[Federal Register Volume 59, Number 29 (Friday, February 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2969]
[[Page Unknown]]
[Federal Register: February 11, 1994]
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Part IV
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 156 and 165
Standards for Pesticide Containers and Containment; Proposed Rules
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 156 and 165
[OPP-190001; FRL-4168-9]
RIN 2070-AB95
Standards for Pesticide Containers and Containment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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SUMMARY: Pursuant to its authority under the Federal Insecticide,
Fungicide, and Rodenticide Act, EPA is proposing container design
requirements for nonrefillable and refillable pesticide containers. EPA
is also proposing procedures, standards, and label language to
facilitate removal of pesticides from containers prior to disposal.
Additionally, this proposal includes standards for containment of bulk
pesticide containers and procedures for container refilling operations.
These proposed regulations are necessary to implement statutory
authority requiring EPA to develop regulations for the safe storage and
disposal of pesticides. Also, preliminary issues related to EPA's
development of effluent limitations guidelines and standards for the
pesticide formulating, packaging, and repackaging industrial category
under the Clean Water Act are summarized.
DATES: Comments on the proposed rule must be received by EPA on or
before May 12, 1994.
ADDRESSES: Submit written comments on the proposed rule, bearing the
document identification number OPP-190001, by mail to: Public Docket
and Freedom of Information Section, Field Operations Division (7506C),
Office of Pesticide Programs, U.S. Environmental Protection Agency, 401
M St., SW., Washington, DC 20460. Deliver comments in person to: Public
Docket and Freedom of Information Section, Field Operations Division
(7506C), Office of Pesticide Programs, U.S. Environmental Protection
Agency, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA 22202.
Information submitted in any comment concerning the proposal may be
claimed as confidential by marking any or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice to
the submitter. Comments will be available for public inspection in Room
1132 at the address given above, from 8 a.m. to 4 p.m., Monday through
Friday, except legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail for the proposed Standards for
Pesticide Containers and Containment: Janice Jensen, Pesticide
Management and Disposal Staff, Office of Pesticide Programs (7507C),
U.S. Environmental Protection Agency, 401 M St. SW., Washington, DC
20460, (703) 305-5288. By mail for the effluent limitations guidelines
and standards for the pesticide formulating, packaging, and repackaging
(PFP) industrial category: Ms. Janet K. Goodwin, Engineering Analysis
Division (4303), U.S. Environmental Protection Agency, Washington, DC
20460, (202) 260-7152.
SUPPLEMENTARY INFORMATION:
The contents of today's preamble are listed in the following
outline:
I. Statutory Authority
II. Background
A. Overview of Amended FIFRA Section 19
B. Phased Implementation of Section 19
C. Container Design, Residue Removal, and Labeling
D. The Container Regulations and their Relationship with the
Pollution Prevention Act
E. Today's Proposal
III. Definitions
A. Definition of Container
B. Definitions for Nonrefillable Container Standards: Container
Design and Residue Removal
C. Definitions for Refillable Container Standards: Container
Design and Residue Removal
D. Definitions for Standards for Pesticide Containment Structures
IV. Nonrefillable Container Standards: Container Design and Residue
Removal
A. Background
B. Today's Proposal
V. Refillable Container Standards: Container Design and Residue
Removal
A. Background
B. Today's Proposal
VI. Standards for Pesticide Containment Structures
A. Background
B. Today's Proposal
VII. Labeling Requirements for Pesticides and Devices
A. Background
B. Today's Proposal
VIII. Upcoming Effluent Limitations Guidelines for Pesticide
Formulators, Packagers, and Repackagers
A. Purpose
B. Applicability
C. Background
D. Expected Approach
E. Pollution Prevention
F. Schedule
IX. Relationship to Other Programs
A. Resource Conservation and Recovery Act (RCRA)
B. Spill Prevention, Control, and Countermeasures (SPCC)
C. Occupational Safety and Health Administration (OSHA)
Requirements
D. Department of Transportation (DOT) Hazardous Materials
Regulations
X. Statutory Review Requirements
XI. Public Docket
XII. References
XIII. Regulatory Assessment Requirements
A. Executive Order 12291
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
I. Statutory Authority
These proposed rules are issued pursuant to the authority given the
Administrator of EPA in sections 3, 8, 19, and 25 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act), 7
U.S.C. 136a, 136f, 136q, and 136w.
II. Background
FIFRA is the law that authorizes EPA to regulate the sale,
distribution, use, and disposal of pesticides in the United States. The
Act requires that EPA license by registration (or specifically exempt
from registration) each pesticide product sold or distributed in the
United States, to ensure that pesticide products will not cause
``unreasonable adverse effects on the environment.'' The term
``unreasonable adverse effects on the environment'' is defined in FIFRA
section 2(bb) to mean ``any unreasonable risk to man or the
environment, taking into account the economic, social, and
environmental costs and benefits of the use of any pesticide.'' As part
of registration, EPA requires the submission of data demonstrating that
the product will not cause unreasonable adverse effects on the
environment. Moreover, EPA reviews and approves the labeling of each
product proposed for registration. The labeling is a fundamental tool
for enforcement of pesticide use. FIFRA section 12(a)(2)(G) provides
that it is unlawful to use a pesticide in a manner inconsistent with
its labeling (commonly called the ``misuse'' provision). Currently 40
CFR 156.10(i)(2)(ix) requires storage and disposal statements on
pesticide labeling.
A. Overview of Amended FIFRA Section 19
Section 19 of FIFRA was amended in 1988, significantly expanding
and strengthening EPA's authority in the areas of pesticide storage,
disposal and transportation. Among other things, that section of the
Act authorizes the Administrator, in conjunction with the registration
or reregistration of a pesticide, to establish:
(1) Data requirements to determine methods of safe storage and
disposal of pesticides [FIFRA sec. 19(a)(1)(A)].
(2) Labeling requirements for the storage, transportation, and
disposal of pesticides, excess pesticides, rinsates, and containers
[FIFRA sec. 19(a)(1)(B)].
Suspended and canceled pesticides were targeted in the amended Act
for specific attention, and EPA was given broad discretionary authority
to prescribe storage, transportation, and disposal requirements by
order or by regulation. Under FIFRA section 19(b), EPA may require the
recall of suspended and canceled pesticides, through either a
``voluntary recall'' by order of the Administrator, or a ``mandatory
recall'' implemented by regulation. Section 19(c) establishes a scheme
for sharing costs for storing suspended and canceled pesticides with
the intent of providing incentives to the manufacturer to expedite safe
disposal of the materials. On May 5, 1993 (Ref. 87), EPA proposed
regulations covering:
(1) Voluntary and mandatory recall plans [FIFRA sec. 19(b)].
(2) Storage and disposal plans; reimbursement of storage costs
[FIFRA sec. 19(c)].
(3) Indemnification, which covers financial losses suffered by end
users as a result of suspension and cancellation of a pesticide product
[FIFRA sec. 15].
Further, section 19 not only authorizes, but mandates the issuance
of regulations in two areas of particular concern:
(1) Pesticide container design standards [FIFRA sec. 19(e)].
(2) Residue removal standards and procedures [FIFRA sec. 19(f)].
Section 12(a)(2)(S) makes it unlawful to violate any regulation
issued under section 19.
B. Phased Implementation of Section 19
The preceding summary illustrates the variety of subjects addressed
by FIFRA section 19. Because of this variety, EPA is implementing FIFRA
section 19 provisions in phases.
Phase I of these regulations, addresses the procedural provisions
of recall, indemnification of end users, and storage and disposal plans
for suspended and canceled pesticides.
Today's Phase II proposal addresses the container design and
residue removal provisions, as well as associated pesticide labeling
requirements necessary to container design and residue removal
implementation. In addition, Phase II addresses containment provisions
for container refilling operations and refillable bulk containers. In
Phase III, EPA plans to address section 19 provisions on data
requirements, additional containment concerns, and storage, disposal,
and transportation of registered pesticides.
C. Container Design, Residue Removal, and Labeling
FIFRA sections 19(e) and (f) grant EPA broad authority to establish
standards and procedures to assure the safe use, reuse, storage and
disposal of pesticide containers. FIFRA section 19(e) requires EPA to
promulgate regulations no later than 3 years after the effective date
of section 19(e) (by December 24, 1991) for ``the design of pesticide
containers that will promote the safe storage and disposal of
pesticides.'' The regulations must ensure, to the fullest extent
practicable, that the containers:
(1) Accommodate procedures used for removal of pesticides from the
containers and rinsing of the containers.
(2) Facilitate safe use of the containers, including elimination of
splash and leakage.
(3) Facilitate safe disposal of the containers.
(4) Facilitate safe refill and reuse of the containers.
EPA must require compliance with regulations issued under section
19(e) no later than 5 years after the effective date of section 19(e)
(by December 24, 1993).
FIFRA section 19(f) requires EPA to promulgate regulations no later
than December 24, 1991 ``prescribing procedures and standards for the
removal of pesticides from containers prior to disposal.'' The
regulations may:
(1) Specify, for each major type of pesticide container, procedures
and standards providing for, at a minimum, triple rinsing or the
equivalent degree of pesticide removal.
(2) Specify procedures that can be implemented promptly and easily
in various circumstances and conditions.
(3) Provide for reusing, whenever practicable, or disposing of
rinse water and residue.
(4) Coordinate with requirements imposed under the Resource
Conservation and Recovery Act (RCRA) for rinsing containers.
Section 19(f) provides that EPA, in its discretion, may exempt
products intended solely for household use.
The underlying concern of these provisions is to provide
appropriate safeguards for activities or processes involving pesticide
containers when these activities fall outside the scope of application
activities that are addressed through labeling. Therefore, EPA
construes the terms ``storage'' and ``disposal'' in the above
provisions broadly, to include activities (such as repackaging) that
affect the safe storage and disposal of pesticide containers. This
broad interpretation is consistent with the legislative history of
section 19 that indicates Congress' intent that ``disposal of
pesticides include preparation for disposal such processes as
packaging, repackaging, recycling, and decanning of pesticide
ingredients required to store or dispose of pesticides safely'' (Ref.
81).
In addition to the specific authorities in FIFRA sections 19(e) and
(f), other FIFRA provisions provide EPA with authority relevant to
regulating pesticide containers:
(1) Section 19(a)(1)(B) authorizes EPA to require that pesticide
labeling contain requirements and procedures for the transportation,
storage, and disposal of the pesticide, its container, rinsate, and any
material used to contain excess pesticides.
(2) Section 19(a)(3) authorizes regulations governing, among other
things, storage, transportation, and disposal of containers of a
pesticide whose registration has been suspended or canceled.
(3) Section 3 provides for registration of pesticides.
(4) Section 8 requires producers, registrants, and applicants for
registration to keep records.
(5) Section 25 provides general regulatory authority.
Today's proposal is issued pursuant to the above authorities and
implements the mandates in sections 19(e) and (f). Three new subparts
to 40 CFR part 165 would be created to implement the statutory mandates
in sections 19(e) and (f): subpart F (nonrefillable container
standards: container design and residue removal), subpart G (refillable
container standards: container design and residue removal), and subpart
H (standards for pesticide containment structures). The regulations in
40 CFR part 156 (labeling requirements) would be amended to require new
residue removal instructions.
In developing this proposed rule, EPA has tended to favor the use
of performance-based standards rather than design-specific criteria.
Performance-based standards are preferred because they allow for
greater flexibility in meeting requirements and can accommodate changes
in technology.
Specifically, proposed subpart F would establish requirements under
sections 19(e) and (f) for nonrefillable containers. The regulations
would facilitate safe use and disposal of these containers through
requirements relating to container integrity, elimination of leaks and
drips during use, and permanent marking of essential information on the
container. In addition, the regulations would facilitate the safe use
of certain rigid containers by requiring standardized closures to
encourage use of closed pesticide dispensing systems. Subpart F also
would require that rigid containers used with dilutable (i.e., allowed
by the label to be diluted prior to application) pesticides be tested
to assure that pesticide residues can be removed from these containers.
These residue removal requirements assure that containers accommodate
residue removal procedures in a way that promotes safe storage and
disposal.
To facilitate safe use, disposal, refill, and reuse of the
containers, subpart G would establish standards for refillable
containers including container integrity and permanent marking. Subpart
G also would implement sections 19(e) and (f) by including procedures
for removal of pesticide residue from refillable containers, and
refilling such containers. These residue removal and refilling
procedures would promote safe storage and disposal of pesticides.
Proposed subpart H would establish standards for containment of
container refilling operations and stationary bulk pesticide
containers. The design and operating requirements for bulk containers
and containment structures (pads and secondary containment) would
promote safe storage by facilitating the safe use, refill, and reuse of
these containers. Subpart H would address the concerns underlying
sections 19(e) and (f) by providing appropriate controls for activities
and processes involving container refill and residue removal that will
assure safe storage and disposal.
The proposed amendments to 40 CFR part 156 would require that the
labeling of dilutable pesticides in rigid nonrefillable containers
include specified residue removal instructions, in accordance with the
direction in section 19(f) to prescribe residue removal standards.
With the exception of the requirements outlined in the preceding
paragraph, this proposal would not require registrants to incorporate
the proposed requirements into the labeling of pesticide products. EPA
recognizes, however, that the pesticide labeling system is generally
viewed by the public as the definitive source of regulatory
requirements for pesticides. EPA therefore requests comment on whether
some or all of the proposed requirements should be referenced by label,
including the option of referencing the regulation on the labeling as
was done with the Worker Protection Standards published August 21, 1992
(Ref. 92).
Additionally, EPA is proposing minor conforming changes to 40 CFR
part 165 to reflect the requirements of this proposal. The rule would
remove outdated or unnecessary definitions from Sec. 165.1, revise or
remove outdated or duplicative material in Sec. 165.2 and Sec. 165.11,
and redesignate and transfer the current part 165 regulations into
subpart A of part 165.
EPA has specified compliance dates in this rulemaking and requests
public comment on these proposed compliance dates. Due to the delay in
promulgating this rule, the statutory time for compliance under FIFRA
section 19(e)(2) (i.e., the 2-year period between December 1991 and
December 1993) will not be directly applicable to the final rule.
Accordingly, as further specified later in this preamble, EPA is
proposing compliance dates which EPA believes are reasonable and
reflect the statutory time frames which Congress intended to apply.
Similarly, FIFRA section 19(f)(2) sets December 24, 1993 as the
deadline for the State programs to ensure compliance with section
19(f). Section 19(f)(2) provides that a State must be carrying out an
adequate program to ensure compliance with section 19(f) by December
24, 1993 in order for the State to continue to exercise its primary
enforcement authority under section 26, or its certification authority
under section 11. Since EPA has not yet promulgated final regulations
under section 19(f), EPA recently published a policy statement setting
forth criteria for determining, on an interim basis, the adequacy of
State programs and a process for States to obtain EPA's interim
determination of adequacy (Ref. 86). EPA will make an interim
determination of adequacy based on an initial written commitment by a
State to conduct several activities that will enable a State to develop
an adequate program for assuring compliance with the final rule. EPA
will announce in the Federal Register its interim determination of
adequacy for the States who submit a written commitment.
EPA solicits comments and data on all aspects of the proposed rule,
including comments on the alternatives discussed in the preamble, and
recommendations (supported by data where appropriate) on alternatives
not specifically discussed in the preamble that would improve the
proposal and achieve the goals of this rulemaking. Where appropriate,
EPA may adopt options other than those included in the regulatory text,
based on information submitted by commenters.
D. The Container Regulations and their Relationship with the Pollution
Prevention Act
Congressional passage of the Pollution Prevention Act of 1990
1 (PPA) makes pollution prevention national policy. Section
6602(b) (42 U.S.C. 13101(b)) identifies an environmental management
hierarchy in which pollution should be prevented or reduced whenever
feasible; pollution that cannot be prevented should be recycled in an
environmentally safe manner, whenever feasible; pollution that cannot
be prevented or recycled should be treated in an environmentally safe
manner whenever feasible; and disposal or other release into the
environment should be employed only as a last resort.
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\1\Enacted as Public Law 101-508, sections 6601 through 6611;
codified as 42 U.S.C. secs. 13101 et seq.
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In short, preventing pollution before it is created is preferable
to trying to manage, treat, or dispose of it after it is created.
According to PPA section 6603(5), source reduction reduces the
generation and release of hazardous substances, pollutants, wastes,
contaminants, or residuals at the source, usually within a process. The
term includes equipment or technology modifications, process or
procedure modifications, reformulation or redesign of products,
substitution of raw materials, and improvements in housekeeping,
maintenance, training, or inventory control. Source reduction does not
include any practice that alters the physical, chemical, or biological
characteristics or the volume of a hazardous substance, pollutant or
contaminant through a process or activity that is not integral to or
necessary for producing a product or providing a service.
Although the PPA focuses largely on industrial pollution
prevention, EPA is also bringing to bear the concept of pollution
prevention or source reduction in other sectors of economic activity.
As EPA's Pollution Prevention Strategy explains, pollution prevention
in agriculture can be the ``development and adoption of low input
sustainable agricultural practices that eliminate the wasteful use of
inputs, such as fertilizers, pesticides, and water,'' and ``soil
conservation and land management practices that prevent erosion of
sediment and runoff of pesticides and fertilizers'' (Ref. 98).
Pertaining to this proposal, section 6604(b)(2) (42 U.S.C.
13103(b)(2)) of the PPA directs EPA to, among other things, ``review
regulations of the Agency prior and subsequent to their proposal to
determine their effect on source reduction.'' EPA believes that this
proposed rule is consistent with the purpose of the PPA's requirement
to consider source reduction. EPA's emphasis on source reduction and on
evaluating rules in light of the environmental management hierarchy is
also entirely consistent with congressional directives in FIFRA section
19. In amending FIFRA in 1988, Congress clearly intended to move the
management of pesticide storage, transportation, and disposal further
up the environmental management hierarchy toward source reduction.
In the context of pesticide containers, EPA believes application of
the environmental management hierarchy has several specific
characteristics:
(1) Improving the design of pesticide containers and enhancing
integrity (Sec. 165.102), and facilitating the removal of residues from
those containers (Sec. 165.104).
(2) Encouraging efficient transfer operations
(Sec. Sec. 165.102(b), (d) and (e)) to increase the amount of pesticide
reaching the intended target, thereby reducing waste and unwanted
environmental releases.
(3) Increasing the efficiency of cleaning operations
(Sec. 165.104(a) and (b)) to reduce wastes and releases resulting from
cleaning.
(4) Improving practices of storing pesticides in bulk containers
and transferring the pesticides from bulk containers into refillable
containers to reduce potential releases of pesticides during storage
(Sec. 165.146).
(5) Encouraging, whenever feasible, increased use of refillable
containers (Sec. Sec. 165.120 through 165.139) to reduce the number of
containers needing disposal, and reduce (Sec. 165.130(b)(1) and
Sec. 165.134(g)) the pesticide residues commingled with those
containers.
(6) Reducing worker exposure during handling by encouraging the use
of closed pesticide dispensing systems (Sec. 165.102(e)).
EPA recognizes that source reduction in the context of pesticides
and agriculture generally has other important components. These include
improving efficiency in pesticide production and formulating processes,
improving application efficiencies, encouraging integrated pest
management and low input sustainable agricultural practices, and
encouraging the use of safer pesticides when pesticides are necessary.
Currently, EPA is pursuing efforts in each of these other areas. For
example, see EPA's Notice of Proposed Rule Making (NPRM) on Effluent
Guidelines for the Pesticide Manufacturing Industry (Ref. 97), and the
Notice relating to Clean Water Act Effluent Limitations Guidelines and
Standards for the Pesticide Formulating, Packaging, and Repackaging
industrial subcategory included in this preamble in Unit VIII. See also
EPA's Notice in the Federal Register on the policy for reduced risk
pesticides (Ref. 89).
In requesting comment on today's proposal, EPA seeks comment on
whether this rule adequately moves pesticide handling ``up'' the
environmental management hierarchy set out in PPA section 6602(b),
specifically to encourage source reduction, and if there are other
options EPA could pursue to further these efforts.
E. Today's Proposal
EPA examined the problems associated with using and handling
containers prior to developing these regulations. Many of the findings
may be found in ``Pesticide Containers: A Report to Congress'' (Ref.
65), cited in this preamble as the Report to Congress and ``State of
the States: Pesticide Storage and Disposal'' (Ref. 70), cited in this
preamble as the State of the States Report. This section gives a brief
overview of current pesticide container types and handling practices in
order to give the reader an understanding of the scope and nature of
container use and handling problems.
1. Numbers of containers. The Report to Congress reported that an
estimated 223 million pesticide containers were manufactured in 1986,
90 million of which held agricultural pesticides. This was probably a
substantial underestimate, since a 1988 survey conducted by the
pesticide industry estimated that 233 million pesticide aerosol
containers alone were manufactured that year, more than the previous
estimate for the total number of pesticide containers in 1986. A more
thorough examination of the diversity of pesticide industries,
pesticide formulations, and container types and numbers can be found in
the Report to Congress and the regulatory impact analysis for the
container design and residue removal regulations (Ref. 67).
2. Types of pesticide containers. Pesticide containers are made
from a variety of materials, including stainless steel; several types
of plastic, including linear high density polyethylene, low density
polyethylene, and cross-linked high density polyethylene; polyvinyl
alcohol, in the form of water-soluble packaging; glass; paper;
cardboard; aluminum; and various combinations of materials, including
teflon, fiberglass, and foil. Pesticides are sold in two general types
of containers. Containers not intended for refill or reuse are by far
the most commonly used container type. This proposal refers to these
containers as ``nonrefillable containers'' (the definition of
``nonrefillable container'' proposed in these regulations is discussed
later in this preamble). Containers intended for refill and reuse are
used predominantly in the agricultural market, with some applications
in industrial and institutional markets, and generally are used to sell
and distribute pesticides in larger quantities. This proposal refers to
these containers as ``refillable containers'' (``refillable container''
is discussed in Unit III of the preamble and defined in proposed
Sec. 165.3).
3. Life-cycle of pesticides and containers. The life-cycle of
pesticides sold and distributed in nonrefillable containers differs
from that of refillable containers.
Pesticides sold in nonrefillable containers pass through the
distribution chain, which varies according to the market, until they
are purchased by the end user. The end user is generally solely
responsible for opening the container, dispensing the pesticide,
removing the pesticide residue from the container (``cleaning'' the
container), and disposing of the container, rinsates, and excess
pesticide.
Pesticides sold in refillable containers have a different life-
cycle. These pesticides are not prepackaged; rather, they are generally
distributed in large, undivided quantities to dealers and retailers,
then dispensed into refillable containers, and sold to the end user.
The refillable container is returned to a dealer repeatedly for
refilling. The sale and distribution of pesticide in this manner, in
bulk form, is similar to the way that gasoline is sold.
Refillable containers may be owned by registrants, dealers,
farmers, and other users. In the mid-1980s, several registrants began
providing end users with inexpensive (approximately $50) refillable
containers or ``minibulks'' in order to encourage their use. As
discussed in Unit III of the preamble and defined in Sec. 165.3, EPA is
proposing to define ``minibulk'' and ``bulk'' refillable containers
into specific size categories. As documented in the Report to Congress
(Ref. 65), registrants and other producing establishments, however, are
finding these containers problematic, partly because they do not have
much control over the farmer-owned containers, and partly because these
containers are not particularly durable. The current trend is toward
more durable and better-designed containers that are owned by the
registrant. These more durable containers cost an average of about
$300.
A producing establishment will typically have from 1 to 10 larger
stationary refillable containers, ranging from 500 gallons to 12,000
gallons, from which a pesticide is dispensed into smaller refillable
containers.
4. Pesticide container integrity. As discussed in the Report to
Congress (Ref. 65), the integrity of any container may be compromised
if the container is constructed of materials that are not compatible
with the pesticide, if the container's design is faulty, if the
container is handled inappropriately or if it is stored under adverse
conditions. For example, the walls of containers may weaken because of
an interaction between the solvent and the container's material of
construction. When stored outside, sunlight can cause photodegradation
of the resins in plastic containers. Container fixtures (e.g., hoses,
valves, sight gauges) may weaken and break at the point where they
attach to the container, especially if the container is plastic and the
fixtures are metal. The stresses induced from minor collisions with
service vehicles, forklifts, and even stresses from normal handling
have caused weakened containers to leak and even burst.
5. Spills and leaks from containers. There are many activities
related to container handling that present a potential for exposing an
end user to pesticides and/or releasing pesticides into the
environment. These problems can occur throughout all phases of
container handling, including opening, dispensing, and closing or
resealing. Certain container design features, such as the position of
handles and openings and the size of the openings, promote spilling and
leaking through splashing and dripping.
The use of closed systems can reduce spills, leaks, and applicator
exposure. Although closed systems are becoming more common, the wide
variety of container opening sizes and designs has restricted the
expansion of their use. Some end users resort to jury-rigging or
altering the closed systems to fit the container, with spillage and
leakage resulting from unsuccessful attempts.
Refillable containers are intended for frequent refill and reuse,
and can reduce the number of containers requiring disposal.
Unfortunately, spills and leaks can occur throughout all phases of
handling minibulk and bulk containers, including cleaning, filling,
transportation, dispensing and storage. In the State of the States
Report (Ref. 70), several States have reported that costly cleanups
have been required at pesticide facilities as a result of fire, failure
of refillable containers, and persistent leaking and spilling of
pesticides at one place over time. Even in light of potential liability
concerns, a significant number of pesticide dealers have not yet placed
their larger refillable containers in protective dikes or secondary
containment structures.
6. Residue removal from containers. Removing pesticide residue
after emptying a nonrefillable container is necessary to minimize human
health and environmental risks, and prepare containers for recycling or
disposal. Pesticide containers that contain residues, if disposed of
improperly, present potential risks to humans and the environment
through contamination of surface and groundwater, direct contact by
humans (such as trash handlers) and animals, runoff and leaching into
sensitive habitats from contaminated soil, contamination of landfills,
and other means. In addition, acceptance of empty containers by
pesticide recycling programs is highly dependent on the cleanliness of
the container.
Container design characteristics may interfere with the removal of
pesticide residues from the container during the cleaning procedure
(residue removal). For example, pesticide can be trapped in the seams
along the top, bottom, and sides of the container, as well as in hollow
handles and threading in the container's opening. Pesticide may also be
adsorbed to the interior walls of the container or absorbed in various
amounts into the container material itself.
7. Current residue removal label language. Label directions on
storage and disposal, which encompass residue removal, are addressed in
40 CFR 156.10(i)(2)(ix). Today's proposal would add additional
requirements to this provision (see Unit VII of this preamble).
III. Definitions
EPA is proposing to revise the definitions in 40 CFR part 165 by
removing a number of the definitions that are outdated or not used in
the regulations, by revising some existing definitions, and by adding a
number of new terms. The definitions now used in 40 CFR part 167 for
``produce,'' ``producer,'' and ``establishment'' would be included in
part 165. In addition, the definitions set forth below, when used in
part 165, would have the meanings as explained. Although many of these
terms are used in more than one of the proposed subparts, the
discussion below is organized according to the subpart that uses the
term most extensively.
A. Definition of Container
EPA proposes to retain the definition of ``container'' that is
currently in the 40 CFR part 165 regulations and recommended
procedures. This definition would ensure consistency with the existing
guidelines on storage and disposal that also will be retained in part
165. The following language would also be added to the definition of
container: ``Containers that are used to sell or distribute a pesticide
product and that are also spray applicator tanks are considered to be
containers for the purposes of this part.'' Vessels that are used to
sell or distribute a product and that are also attached to the
application equipment, for example, the ``Lock and Load'' system or
small volume returnable containers that are a part of a direct
injection system, would be considered containers. This language would
be added to assure that if these types of equipment are used as
containers, they would be regulated as such under section 19.
EPA requests comment on whether the definition of ``container'' for
purposes of FIFRA section 19 should be broadened to accommodate the
containment provisions included in this proposal in light of the new,
broader authority granted by Congress in the revisions to section 19.
In particular, should the definition of container be expanded to
include the secondary containment structure?
B. Definitions for Nonrefillable Container Standards: Container Design
and Residue Removal
EPA proposes that ``nonrefillable container'' be defined as a
container that is designed and constructed for one-time filling only. A
nonrefillable container cannot be reused or refilled. EPA intends that
this definition include, but not be limited to, containers used for the
following pesticide products: baits, traps, collars, and bars.
The proposed definition of ``agricultural pesticide'' (also used in
the other proposed subparts) would apply to pesticides that are labeled
for use sites described in the definition of ``agricultural commodity''
[Sec. 171.2(a)(5)] as follows: ``The term 'agricultural commodity'
means any plant, or part thereof, or animal, or animal product,
produced by a person (including farmers, ranchers, vineyardists, plant
propagators, Christmas tree growers, aquaculturists, floriculturists,
orchardists, foresters, or other comparable persons) primarily for
sale, consumption, propagation, or other use by man or animals.'' The
term ``agricultural pesticide'' would also apply to pesticides intended
for use in a nursery or greenhouse, in order to more fully include
pesticide use sectors that currently use closed systems. EPA intends
the proposed definition to include general and restricted use
pesticides.
A modification of the existing definition of ``triple rinse'' and a
new definition of ``pressure rinse'' are proposed in order to better
describe the triple and pressure rinsing procedures that are proposed
in the amendments to 40 CFR part 156.
C. Definitions for Refillable Container Standards: Container Design and
Residue Removal
The proposed definition of ``design type'' is intended to clarify
what constitutes a different container design and applies to both
refillable and nonrefillable containers. If any of the parameters
listed for defining the design type are different between two
containers, the containers would have different designs. This is
important in terms of whether a container would need to be tested. The
definition of design type is based on the definitions of packaging
design type and intermediate bulk container (IBC) design type in the
United Nations Recommendations on the Transport of Dangerous Goods
(U.N. Recommendations) and the U.S. Department of Transportation (DOT)
definition of ``different packaging'' in HM-181 [performance-oriented
packaging standards for the Hazardous Materials Regulations] (Refs. 82
and 83).
In section 9.7.1.2 of the U.N. Recommendations (Ref. 76), ``a
packaging design type is defined by the design, size, material and
thickness, manner of construction and packing, but may include various
surface treatments. It also includes packagings which differ from the
design type only in their lesser design height.'' The definition of IBC
design type in section 16.1.4.2.1 is similar. DOT regulations, 49 CFR
178.601(c)(4), state, in part, that:
A different packaging is one that differs (i.e. is not
identical) from a previously produced packaging in structural
design, size, material of construction, wall thickness or manner of
construction, but does not include: (i) a packaging which differs
only in surface treatment; ...; (iii) A plastic packaging which
differs only with regard to additives ...; (v) Packagings which
differ from the design type only in their lesser design height.
EPA is proposing to adopt a combination of the criteria in the DOT
description of different packaging to define a design type.
Specifically, Sec. 165.3 would specify that a container design type is
defined by certain parameters: structural design, size, material of
construction, wall thickness, manner of construction, and, for
refillable containers as appropriate, pump fittings. With several
exceptions, a change in any one of these parameters would constitute a
different design type. The exceptions are that containers with various
surface treatments and containers that differ only in their lesser
design height may be included in one design type.
The term ``structural design'' as used by DOT refers to the general
shape and appearance of a container, e.g., cylindrical or cubical, as
well as any recessed areas or otherwise distinctive features of the
container. ``Manner of construction'' refers to the way the container
is made and would distinguish, for example, between plastic containers
that are blow molded and those that are rotationally molded.
EPA is proposing to add pump fittings to the list of critical
parameters, because EPA believes this design feature may have a
significant impact on the drop test performance of a container.
As an example, a minibulk container design type is characterized by
its structural design, size, material of construction, surface
treatment, wall thickness, manner of construction, and pump fittings.
If any one of these design parameters is different when comparing two
containers (except design height or surface treatment), the containers
would be considered to be different design types and each container
design type would have to be drop tested in accordance with
Sec. 165.124(d).
The use of ``one-way valves'' is intended to prevent unauthorized
persons from placing material into a refillable container. EPA requests
comment on whether the definition of one-way valve proposed in
Sec. 165.3 is adequate to describe the technology necessary to prevent
a person from inserting a substance into a container through that
valve.
In this proposed rule, a ``refillable container'' is defined as ``a
container that is intended to be filled with pesticide more than
once.'' A container would be ``intended to be filled with pesticide
more than once'' if it is on a registrant's list of acceptable
refillable containers for a pesticide product, as specified in proposed
Sec. 165.130(b)(2).
The regulations propose definitions for four major types of
refillable containers: ``liquid minibulk,'' ``liquid bulk,'' ``dry
minibulk,'' and ``dry bulk.'' The distinctions are based on the kind of
pesticide (i.e., liquid or dry) the container is designed to hold and
the size of the container. EPA believes it is appropriate to define
different container terms for each of the four major types because each
is designed and handled differently, and the appropriate design or
performance standards may vary.
First, refillable containers are distinguished by whether they are
designed and constructed to hold liquid or dry pesticide. The four
major types of refillable containers do not include containers for
pesticides that are gases or that are in a semi-solid state, such as
gels. EPA does not intend to regulate refillable containers for gaseous
pesticides at this time because EPA is not aware of problems with this
type of container. EPA is not aware of any pesticide gels that are
distributed or sold in refillable containers.
The second distinction among the types of refillables is based on
the size of the container, which is usually a good indicator of whether
the container will be portable or stationary. In general, the term
``minibulk'' is intended to identify a container that is considered to
be portable. The term ``bulk'' usually refers to a container that is a
stationary storage container. However, EPA is proposing a definition
based on size rather than portability because size is an objective
criterion, while ``portability'' is a more subjective concept that is
difficult to describe precisely.
The size criteria are different for liquid and dry refillables. For
liquid minibulk containers, the proposed rule would define the
container as capable of holding up to and including 3,000 liters (793
gallons), which is based on the United Nations (U.N.) definition of
intermediate bulk containers (Ref. 76). Section 16.1.2.1 of the U.N.
Recommendations defines IBCs, in part, as ``rigid, semi-rigid or
flexible portable packagings, other than those specified in Chapter 9,
that: (a) have a capacity of not more than 3.0 m3 (3,000 litres),
....''
This proposed definition of liquid minibulk container does not have
a lower quantity limit. Therefore, the proposed regulatory definition
of liquid minibulk would include those plastic and metal portable
containers that are currently referred to as minibulks, as well as the
metal 15- and 30-gallon containers that are commonly called small
volume returnables, or microbulks. The proposed regulatory definition
of liquid minibulk would apply to containers with, for example, a
capacity of several ounces if the container could be refilled.
The definition of a ``liquid bulk container'' would be similar to
that of a liquid minibulk, but with a capacity limit of undivided
quantities greater than 3,000 liters (793 gallons).
Most portable refillable containers, i.e., those used to transport
pesticide products from a dealer to a farm, have capacities of 250
gallons or less. Nearly all the portable containers for pesticides used
in the agricultural, institutional, and industrial markets are 600
gallons or less. Most stationary storage tanks have capacities of at
least 1,000 gallons. Therefore, EPA believes that the size limit of
3,000 liters (793 gallons) for liquid refillable containers is
reasonable and appropriate.
The size separation for dry refillable containers is intended to
distinguish between minibulk and bulk containers in a similar way. The
criterion of 2,000 kilograms (4,409 pounds) is based on the capacity of
containers that are commonly used today. To EPA's knowledge, the
largest portable refillable container (that is not a transport vehicle)
currently used for dry pesticides can hold up to 1 ton (907 kilograms
or 2,000 pounds) of product. To account for the possible development of
larger minibulk containers through technological advancement, EPA more
than doubled this quantity to 2,000 kilograms (4,409 pounds). In other
words, the size criterion is intended to accommodate the refillable
containers currently used to sell and distribute dry formulations and
to allow for the development of larger containers in the future. EPA
requests comment on whether this quantity limit is appropriate or
whether EPA should base the size criterion for dry refillable
containers on the capacities of existing containers.
A ``refiller'' is defined as a person who engages in the activity
of repackaging pesticide product into refillable containers. A refiller
could be a registrant, a person operating under contract to a
registrant, or a person operating under written authorization from a
registrant.
A ``refilling establishment'' is defined in the proposal as ``an
establishment where the activity of repackaging pesticide product into
refillable containers occurs.'' This definition is intended to include
every place where a refillable container is filled or refilled with
pesticide product from another refillable container (that is not a
transport vehicle). The definition would not include producing
establishments that fill only nonrefillable containers for distribution
and sale.
Refilling establishments are a subset of producing establishments.
Refilling establishments must be in compliance with all existing
requirements for producing establishments, including FIFRA sections 7
and 8 and EPA's regulations in 40 CFR part 167. The part 165
regulations would place additional requirements on refilling
establishments.
EPA is proposing a definition for the term ``repackage'' in
Sec. 165.3. For purposes of this part, repackage means to transfer a
pesticide formulation from one container to another without a change in
the composition of the formulation or the labeling for sale or
distribution. Transfer of a pesticide from one storage tank to another
would not be repackaging. ``Repackaging'' covers a broader range of
activities than ``refilling,'' which refers to repackaging into
refillable containers, i.e., refilling is a subset of repackaging. For
example, a registrant can repackage a product from a 55-gallon drum
into nonrefillable 2.5-gallon jugs, which would not be considered to be
refilling. Another difference between the two terms is how they are
used: pesticide products are repackaged, while pesticide containers are
refilled. This proposal focuses on ``refilling refillable containers
with pesticide product for distribution or sale'' and ``repackaging
pesticide product into refillable containers for distribution or
sale,'' which have the same meaning.
D. Definitions for Standards for Pesticide Containment Structures
Several definitions proposed in subpart A pertain to standards for
pesticide containment structures found in subpart H of the proposed
rule. These definitions, discussed below, include: appurtenances,
containment pad, containment structure, operator, owner, pesticide
dispensing area, secondary containment unit, stationary bulk container,
and 25-year, 24-hour rainfall event.
The proposed definition for ``stationary bulk container'' would
include any bulk container that holds pesticide, including transport
vehicles such as trucks and rail cars, provided that the container
remains in place at a facility for 14 or more days. Containers holding
concentrated pesticides or dilute pesticides (e.g., field dilutions or
rinsates) could qualify as stationary bulk containers.
The proposed definition of ``appurtenance'' is intended to identify
the types of conduits that are used when pesticides are dispensed to
and from containers. For example, all the pipes and associated valves,
pumps, and meters running from a stationary bulk container to the end
of the pipe where pesticide is discharged would be considered
appurtenances.
Certain stationary bulk containers and their appurtenances would be
required by subpart H to be protected by a ``secondary containment
unit.'' The term ``secondary'' refers to the containment structure's
function as a backup in case of leaks or spills from the bulk container
or its appurtenances. Such leaks and spills could range from relatively
small volumes (e.g., slow drips from a poorly sealed valve) to release
of the entire contents of the bulk container, such as during container
failure.
The term ``pesticide dispensing area'' would include any area where
pesticide is transferred out of or into a container and is intended to
include direct transfers (e.g., container to container) or indirect
transfers (e.g., those involving appurtenances) of pesticides. The
vessel from which or into which the pesticide is transferred could be
of a wide variety (e.g., container, application equipment, transport
vehicle, etc.). The pesticide being transferred could be in a form as
sold and distributed or pesticide that has been diluted (e.g., for
field application or from container-cleaning operations).
As described in subpart H, certain pesticide dispensing areas would
be required to be protected by a ``containment pad.'' A containment pad
is a structure that provides a means of spill control at a pesticide
dispensing area, while a secondary containment unit serves as spill
control for stationary bulk containers. As proposed in subpart H, a
containment pad could be constructed as an integral component of a
secondary containment unit, or vice versa.
The more general term ``containment structure'' would be defined in
Sec. 165.3 to mean either a secondary containment unit or a containment
pad.
The term ``operator,'' as it pertains to subpart H, would mean any
person in control of, or having responsibility for, the daily operation
of a facility at which a containment structure is required. The term
``owner'' would mean any person who owns a facility at which a
containment structure is required.
Subpart H refers to the term ``25-year, 24-hour rainfall event,''
defined as a rainfall event with a probable recurrence interval of once
in 25 years, in describing a design criterion to prevent stormwater
run-on at containment structures. The magnitude of such rainfall events
is reported as inches of liquid precipitation and can vary
geographically.
IV. Nonrefillable Container Standards: Container Design and Residue
Removal
A. Background
Proposed subpart F would revise 40 CFR part 165 to facilitate the
safe use and disposal of nonrefillable pesticide containers by
establishing container design criteria for all nonrefillable containers
and residue removal laboratory performance standards for rigid
containers containing dilutable pesticides.
Nonrefillable containers are the most common type of containers
used for the sale and distribution of pesticides. Nonrefillables come
in many types and shapes ranging from small aerosols, 1-quart plastic
containers, 2.5-gallon jugs, 5-gallon buckets, and bags of all sizes to
drums (55 gallons and larger). Nonrefillables are used by pesticide
applicators in every market sector, and are especially prevalent in the
household market.
As will be discussed more fully later in this document, the
problems associated with the use of nonrefillable containers include
spilling, leaking, and splashing during the handling of the container.
Unwanted release of pesticide may occur during the opening, closing,
pouring, and emptying of the container. Pesticide residues may be
difficult to remove from the inside of containers if the pesticide
adheres to the container's walls or is trapped in seams, lips and
handles. These residues may be released to the environment and could
contaminate surface and groundwater and sensitive habitats as a
consequence of poor container handling and disposal practices.
Containers with residues may be difficult to dispose of in municipal
solid waste facilities or to recycle because facility operators
regularly reject dirty containers in response to contamination
concerns. A more thorough examination of the spilling and splashing
problems associated with current container designs, the impact of
residues on container disposal and recycling, the diversity of
pesticide industries, pesticide formulations, packaging practices, and
quantities and types of containers can be found in the Report to
Congress (Ref. 65).
B. Today's Proposal
Subpart F of today's proposed regulations contains the
nonrefillable container design standards, a residue removal performance
standard, and certification and recordkeeping requirements.
The definition section of proposed subpart A of this NPRM contains
definitions of terms used in proposed subpart F and in related subparts
of today's proposal. Terms in the proposed definition section that are
important to the understanding of subpart F include: Agricultural
pesticide, container, design type, and nonrefillable container.
1. Scope and applicability. Section 165.100 would provide that
subpart F includes nonrefillable container design requirements and
performance standards. These requirements and standards would reduce
the risks to users and the environment from pesticide containers that
spill and leak during use or retain pesticide residue upon emptying.
All nonrefillable containers used for the distribution and sale of
pesticides would have to meet these performance standards and
requirements. The requirements in subpart F would apply to registrants,
which means that containers for unregistered pesticides would not be
subject to these requirements. EPA requests comment on whether
unregistered pesticides should be subject to these requirements and, if
so, whether the requirements should extend to all unregistered
pesticides.
Proposed Sec. 165.100 would state that subpart F does not apply to
manufacturing use products. ``Manufacturing use product'' is defined in
40 CFR 158.153(h) and ``end use product'' is defined in 40 CFR
158.153(b).
In order to be excluded from the scope of this rule, a MUP or
formulation intermediate would have to be intended solely for
formulation into other pesticide products and be labeled for
formulation use only. Any product that bears end uses, including
industrial products such as cooling towers biocides or paint
preservatives, regardless of whether they may also bear manufacturing
uses or could under current policies be used for pesticide formulation,
would be covered by this rule.
EPA is proposing to exclude products that are solely MUPs from
subpart F at this time because EPA has a limited amount of information
on the kinds of containers used for MUPs and EPA is not aware of any
problems that have occurred with containers for MUPs. Because MUPs are
handled by registrants and workers who are used to and trained to
handle chemicals on a regular basis, it is possible that the
stewardship of MUP containers is better than the stewardship of end use
product containers at other levels of the pesticide distribution chain.
EPA's study of pesticide containers and the resulting Report to
Congress (Ref. 65) focused on containers holding end use products. EPA
has data and documentation of problems for end use product containers
and has drafted these proposed regulations to address these known
problems.
While EPA is not proposing to include the containers of MUPs in
this proposal, EPA is strongly considering expanding the applicability
of subpart F to include MUPs in the final rule. Because MUPs generally
are more concentrated than end use products, it may be appropriate to
require the manufacturing use product containers to meet the
requirements of subpart F. EPA requests comments and information on the
problems, handling, and disposal of MUP containers, and on whether MUP
containers should be subject to the same requirements as end use
product containers or should be subject to different standards than end
use product containers.
2. Container design standards. Proposed Sec. 165.102(a)(1) would
prohibit a registrant from distributing and selling a pesticide product
in a nonrefillable container that does not meet the container design
standards and requirements of subpart F.
Section 165.102(a)(2) would state that information on container
failures or other incidents involving pesticide containers that may
result in releases of pesticide may be reportable under FIFRA section
6(a)(2). This proposed provision would not establish new reporting
requirements; the reference to FIFRA section 6(a)(2) provisions is
included to facilitate the reporting of container failures to EPA.
Additionally, EPA would delete Sec. 165.2(g), relating to notifying the
Regional Administrator, because EPA believes that FIFRA section 6(a)(2)
provides for adequate protection.
For purposes of regulating under section 19, EPA is interested in
receiving reports of container failures and other related incidents in
order to evaluate the effectiveness of the regulations, to discover
potential problems that may need to be addressed in future rulemakings,
to identify container design types that may not meet the proposed
requirements, and to determine if certain container design types have a
problem with container integrity and strength over time.
FIFRA section 6(a)(2) requires registrants to report information on
unreasonable adverse effects of a pesticide. EPA published a policy on
reporting under section 6(a)(2) in the Federal Register on July 12,
1979. On September 24, 1992, EPA published a proposal for 40 CFR part
159, Reporting Requirements for Risk/Benefit Information (Ref. 91),
that specifically addresses reporting container failures under section
6(a)(2).
The part 159 proposal includes the following as an example of
reportable container failures: ``The registrant receives verifiable
reports that five cans of the registrant's product leaked 3 years after
the registrant sold them. The registrant has no information regarding
incidents of toxic and adverse effects caused by leaks. Nonetheless,
the registrant should know that such information about container
failures may raise serious questions about the proper terms and
conditions of registration of the product, due to the possibility of
uncontrolled, unpredictable exposure to the product or its residues, as
demonstrated by the series of incidents. Therefore the information
would have to be submitted within 30 calendar days of the time the
registrant possesses or knows of the information. However, if the
registrant investigates, and, within the time permitted, discovers that
three cans leaked because they were stored under conditions which were
neither in accordance with the labeling or commonly recognized practice
(such as the cans were damaged in a warehouse fire), the series of
incidents need not be reported unless that registrant has knowledge
that EPA is considering terms and conditions of registration to which
such information would be relevant.''
EPA believes that FIFRA section 6(a)(2) provides an adequate means
of obtaining information about container failures. However, this
reporting mechanism is dependent upon registrants being notified about
container failures by dealers, refillers, and even end users. EPA
believes that there are many market-based reasons for dealers or
refillers to notify the registrant of container failures, including:
(1) By making the registrant (who would be responsible for the
containers meeting the part 165 standards) aware of the problems, the
registrant could improve the containers, thus alleviating the dealer's
or refiller's problems.
(2) The dealer or refiller may try to obtain financial assistance
from the registrant to replace the failed container and lost product.
(3) If the container failure is associated with a pesticide
release, the dealer or refiller might want to obtain guidance and
financial compensation on reporting responsibilities, spill
remediation, and disposal.
Despite these market pressures, EPA is concerned that registrants
may not become aware of container failures because it is not mandatory
for dealers or refillers to report to registrants. EPA considered other
mechanisms for the reporting of container failures, including requiring
dealers and refillers to report container failures to the registrant.
The registrant, of course, is subject to reporting adverse effects
information under FIFRA section 6(a)(2). This option would ensure that
registrants receive reports of container failures, thus increasing the
potential for reporting to EPA. Another option considered by EPA was to
require dealers and refillers to report container failures directly to
EPA. This option would ensure that EPA receives reports of container
failures in a very timely manner.
EPA requests comments on the proposed approach of relying on market
forces and the existing FIFRA section 6(a)(2) mechanisms to provide EPA
with container failure information and on the other reporting options.
EPA particularly requests comments on the burden to the various parties
under each of the reporting options.
Proposed Sec. 165.102(a)(3) would clarify that compliance with the
proposed part 165 regulations would not be an exemption from DOT's
Hazardous Material Regulations at 49 CFR parts 171 through 180. If a
pesticide is a DOT hazardous material, the pesticide would be required
to be packaged in compliance with both DOT and EPA regulations.
3. Container integrity. EPA is proposing in Sec. 165.102(b) to
require that all nonrefillable container design types prevent leakage
under conditions of normal storage, distribution, sale, and use. In
choosing a general performance standard, EPA recognizes that not every
possible storage or use condition can be anticipated, but that normal
environmental conditions, the effects of long term storage, and
container/formulation interactions should be considered by the
registrant when choosing packaging for a pesticide product.
The risk of exposure to humans, animals, and the environment from
concentrated pesticides is greatly increased if the pesticide is not
completely and securely confined in its container during storage.
Pesticide containers may lose their structural integrity during
mishandling or when stored under various conditions (especially long-
term storage), including: (1) Storage in extremely high and low
temperatures, (2) storage of bags and cardboard containers under humid
conditions (damp basements and regions of the country that regularly
experience high humidity), and (3) storage of certain plastic
containers in direct sunlight, resulting in photodegradation of the
plastic. Incompatibility between the pesticide formulation and the
construction material(s) may also result in degradation or failure of
the container.
A discussion of integrity problems of nonrefillable containers may
be found in the Report to Congress (Ref. 65).
Section 165.102(b) would also require that the container's
construction materials be compatible with the formulation.
Consideration of any chemical reactions that could occur between the
container and the formulation will allow the registrant to choose a
container that is made of materials that will not react with the
formulation.
Compatibility is intended to cover a broad range of potential
occurrences. EPA does not consider a pesticide formulation and
container to be compatible if, for example, the formulation: (1) Is
corrosive to the container, (2) causes softening, premature aging, or
embrittlement of the container, or (3) otherwise causes the container
to weaken or to create the risk of discharge. A container and
formulation are not compatible if there is a significant chemical,
electrolytic, or galvanic reaction between the two. Also, a container
and formulation are incompatible if there is some interaction between
the two, such as the active ingredient permeating the container wall,
that would cause the formulation to differ from its composition as
described in the statement required in connection with its registration
under FIFRA section 3. EPA requests comments on whether this
description of compatibility is adequate and/or whether EPA should
define compatibility in the regulations.
EPA requests comments on the ability of registrants to comply with
the nonrefillable container integrity standard as well as the need for
additional or alternative requirements, such as a drop test.
EPA envisions the nonrefillable container integrity standard being
enforced in situations where significant leakage problems occur for a
given container design type and formulation. Existing enforcement
mechanisms, such as a stop sale, use, or removal order (SSURO), could
be used to prevent the further sale or distribution of that container/
formulation combination.
EPA is considering the development of a standard for container
failure frequency to define what would be considered a violation and to
clearly establish a violation of the proposed container integrity
standard. Noncompliance would result if containers of a particular
design type failed at a frequency greater than that established by EPA.
A nonrefillable container that fails at a rate exceeding the failure
frequency could be banned from the distribution and sale of pesticide.
EPA requests comments on the establishment of a container failure
frequency and requests specific suggestions for methods to determine
and to set such a standard.
4. Permanent markings. Proposed Sec. 165.102(c) would require
certain information, specific to the pesticide sold or distributed in
the container, to be marked permanently on every nonrefillable
container. Permanent marking includes, but is not limited to, etching,
embossing, ink jetting, stamping, heat stamping, mechanically attaching
a plate, molding, or marking with durable ink. EPA intends that the
information be visible and fixed on the container for the lifetime of
the container. This permanent marking would be in addition to the label
and labeling, unless the label itself is a permanent part of the
container material (e.g., etched, ink jetted, stamped, or molded).
Proposed Sec. 165.124(b) of subpart G would require certain information
to be permanently marked on refillable containers. (See the discussion
in Unit V.B.3 of this preamble.) While permanent marking means the same
thing for nonrefillable and refillable containers, EPA anticipates that
the containers will be permanently marked using different methods. For
example, EPA anticipates that most nonrefillable containers would be
permanently marked by ink jetting, embossing, or marking with permanent
ink, while refillables would be permanently marked by molding or
mechanically attaching a plate.
The information proposed to be permanently marked includes the EPA
registration number of the pesticide [Sec. 165.102(c)(1)] and the name,
symbol, or code of the material(s) from which the nonrefillable
container is constructed [Sec. 165.102(c)(2)].
a. EPA registration number. This will allow for the identification
of the pesticide even if the label is missing or illegible,
facilitating the safe disposal of excess pesticide and containers. When
the EPA registration number of the product cannot be confirmed or
identified, the current or previous contents of the container and its
residue are unknown. Identification of the contents by an analytical
chemistry laboratory can be costly and may not provide complete
information (for instance, the exact product may not be identifiable).
Waste management facilities and municipal collection programs usually
consider the cost of identification to be prohibitive, and may refuse
to accept unidentified pesticide products because of potential
liability under the Resource Conservation and Recovery Act (RCRA) or
the Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA). Unidentifiable pesticides have been rejected from
pesticide collection programs in several States (for example, Maine,
Minnesota, North Carolina, and Virginia) (Ref. 70). Users may keep
unidentifiable pesticides and containers in storage indefinitely, or
may even resort to open dumping. State authorities who find quantities
of pesticide containers with illegible or missing labels in open dumps
end up assuming the cost of identification if the user cannot be found.
b. Material of construction. This will help recycling programs
identify container materials and encourage the recycling of pesticide
containers, thereby facilitating safe disposal of containers and
furthering EPA's waste minimization goals. EPA is not proposing a
system or code to identify the material of construction, because there
is no one universally accepted or mandated scheme at this time. The
construction material should be identified clearly enough so that
persons who are not container manufacturers can determine the material
of construction. To EPA's knowledge, there are a limited number of
materials currently used to produce pesticide containers. Therefore,
EPA does not anticipate identifying the container material in the
absence of a specified code to be problematic.
Several independent organizations have developed material
identification mechanisms. One well-known organization, the Society of
the Plastics Industry (SPI), has assigned numbers to certain groups of
plastics. The numbers are engraved or embossed directly on the
container to aid in the quick identification of the material. Certain
beverage can manufacturers print the name of the material (steel,
aluminum) on the container. EPA anticipates that most registrants will
use either the SPI code or the material name to mark nonrefillable
containers with the material of construction. However, there are
existing packaging regulations and standards that address
identification of the material of construction. Container standards
such as the DOT Specifications 56 and 57 for metal portable tanks and
the Midwest Agricultural Chemicals Association (MACA) voluntary
standards establish conventions for identifying the material of
construction for larger, refillable containers, as discussed in Unit
V.B.3 of this preamble.
5. Container dispensing capability. EPA believes that a regulation
that assures the safe use of containers should apply to all aspects of
normal use of the container, including the elimination of splash and
leakage during pouring of the pesticide from the container, closing or
resealing the container, and storage and cleaning of the container.
Proposed Sec. 165.102(d) would require nonrefillable containers
containing liquid pesticides to be designed and constructed to:
(1) Pour from the container in a continuous, coherent stream (i.e.,
without glugging and/or splashing) [Sec. 165.102(d)(1)].
(2) Dispense without dripping or leaking down the outside of the
container at any time during the dispensing or after the container has
been emptied [Sec. 165.102(d)(2)].
(3) Once the container has been resealed, not allow any pesticide
or rinsate to escape from the container during storage or while the
user is agitating the container during the triple rinse residue removal
procedure [Sec. 165.102(d)(3)].
The Report to Congress (Ref. 65) concludes that certain container
design features can result in spilling, splashing, glugging, dripping,
and leaking during normal use activities, including:
(1) Solid handles can promote glugging during pouring because of
inadequate air flow back into the container.
(2) Handles on top of the container can position the user's hand in
likely splash areas.
(3) The design and position of the opening can contribute to
leakage/drippage of the pesticide down the side of the container during
and after dispensing.
(4) Once opened, the lid, cap, or other closure mechanism may not
securely reclose the container, and may result in leakage and spillage
of pesticide during storage, transportation, and container agitation
during the triple rinse residue removal procedure.
EPA is not proposing specific numerical standards or test methods
to verify these design standards. The Report to Congress (Ref. 65)
contains a method to demonstrate glugging based on a variation in
internal pressure of the container and this method could be adapted for
use by registrants. The registrant could use the data from this method
or use photographic evidence to demonstrate dispensing capability, as
well as for other aspects of the design standards.
6. Standardized closures. The safe use of pesticide containers
extends to safe dispensing, and closed systems (also known as closed
transfer systems) allow for the safest possible transfer consistent
with typical pesticide dispensing procedures. Applicator exposure,
spills, leakage, and splashing during the dispensing of pesticide from
the container have been shown to be reduced when a closed system is
used. To facilitate and encourage the use of closed systems, EPA is
proposing in Sec. 165.102(e)(1) to require the standardization of
container closures for liquid agricultural pesticides.
Pesticide container closures come in a wide variety of sizes and
shapes, including pull-off tabs, pop-up funnels, and closures and
openings with or without threading. The current nonuniformity among
container closures makes it difficult for a user to incorporate closed
transfer systems into handling practices. Users may have to purchase or
obtain many adapter devices to fit all of the container types to the
closed system(s) they own. Lacking a proper adapter, a user may try to
secure the closed system to the container using whatever means is
available. If this jury-rigging fails, leaking and spilling may result.
Moreover, closed systems are not available for many container opening
styles. The standardization of the container closure (and therefore the
opening also) would encourage and facilitate the use of closed systems
by limiting the number of adapters and/or closed systems a user would
have to own.
Closed systems are used predominantly in the agricultural sector,
although they are growing in popularity in the industrial and
institutional markets. A growing number of registrants are requiring
the use of closed systems as a means of reducing applicator exposure.
Some States (California, notably) are also requiring that closed
systems be used with certain pesticides in certain application
situations. EPA is targeting agricultural pesticides with the
standardized closure requirements. EPA has limited information on the
use of closed systems in other markets, such as industrial and
institutional. EPA requests information on the use of closed systems in
other pesticide sectors, including the types of systems, costs, extent
of use, and comments on whether a standardized closure requirement
would facilitate the use of closed systems.
Section 165.102(e)(1) proposes four closure sizes (two bungs and
two screw caps) whose design specifications have been adapted from caps
and bungs commonly found in the agricultural sector and from current
voluntary industry standards (Ref. 90). Section 165.102(e)(1) also
proposes that only rigid containers with a capacity greater than or
equal to 3.0 liters (0.79 gallons) would have to conform to the closure
specifications due to the constraints of adapting the closure
specifications to small containers. Also, smaller containers are not
used as often in the agricultural sectors.
Section 165.102(e)(2) would permit a registrant to request and
justify the need for an exemption from the standardized closure
requirement. EPA recognizes that the use of a nonstandardized closure
with certain pesticide formulations may result in a further reduction
of applicator exposure, or may be required for proper mixing, loading,
or application. Because EPA believes that most agricultural
formulations can be accommodated using the four proposed closures, EPA
anticipates a limited number of situations where non-standardized
closures might be appropriate. However, EPA would consider any requests
for a waiver from the standardized closure requirement and would
carefully evaluate them with respect to the criteria set out in
Sec. 165.119(b).
The proposed requirement for standardized closures should not
overlap with the Child-Resistant Packaging requirements for residential
use pesticides (40 CFR part 157), unless a pesticide product's labeling
allows both the use on agriculture sites and residential use [as
defined in Sec. 157.21(e)], and the pesticide is packaged in a
container larger than 0.79 gallons (3.0 liters) but less than 5.0
gallons (18.9 liters). EPA would consider the registered use sites when
considering a request from a registrant to use a non-standardized
closure.
Section 165.102(e)(3) proposes to exempt aerosol and pressurized
containers from the requirement for standardized closures because the
closures are not appropriate for the typical design used to dispense
aerosol pesticide from containers. Pesticides packaged in aerosol and
pressurized containers are considered to be those products that are
sold under pressure where the pesticide cannot be poured or dispensed
from the container as a liquid, the container is not designed to allow
the opening of the container for dispensing as a liquid, and where the
containers are designed to contain pressurized materials.
7. Residue removal-- a. The residue removal problem. FIFRA section
19(e)(1)(B)(i) requires EPA to promulgate regulations that ensure, to
the fullest extent practicable, that the design of pesticide containers
accommodates procedures used for the removal of pesticides from the
containers and the rinsing of the containers. In addition, FIFRA
section 19(f)(1)(B)(i) states that the regulation may specify pesticide
residue removal standards providing for, at a minimum, triple rinsing
or the equivalent degree of pesticide removal. EPA believes it is the
intent of Congress to ensure that pesticide containers are capable of
being cleaned at least to a level that is equivalent to triple rinsing.
In order to fulfill this intent, EPA is proposing to set a residue
removal performance standard that certain pesticide products would be
required to meet. The performance standard would act as a benchmark for
residue removal by specifying the maximum quantity of pesticide active
ingredient that can be found in rinsate after a specified residue
removal procedure is used. EPA would require that a specified level of
pesticide residue removal be achieved in the laboratory before a
registrant may distribute or sell a pesticide product in a
nonrefillable container. This performance standard would be applicable
to all registered products within certain categories of container and
formulation combinations.
EPA believes that if pesticide containers are capable of being
cleaned to a high level, users will be able to achieve a higher degree
of container cleanliness prior to disposal or recycling. EPA believes
human and environmental exposure and risks are posed by pesticide that
is readily available in the container, specifically, the pesticide that
can escape from an empty container during storage and transportation to
a disposal facility. Pesticide container recycling programs and
municipal waste facilities report the frequent rejection of certain
pesticide formulation and container combinations because of
unacceptable pesticide residues (Refs. 16, 23, 24, 29, 37, 49 and 65).
EPA is proposing a performance standard that affords a practicable
level of residue removal that is achievable for the majority of
pesticide products, while targeting those pesticide/container
combinations that have difficulty in achieving an acceptable level of
residue removal, such as those frequently rejected from recycling
programs.
EPA believes that proper residue removal will encourage recycling
and reduce human and environmental exposures to pesticide residues from
empty, unrinsed containers. Residues from containers can contaminate
soil, surface water, and groundwater, posing a risk to wildlife,
sensitive habitats, and human health (examples: drinking water and
exposure to empty containers by trash handlers and children) (Refs. 20
and 65).
The Report to Congress and other sources conclude that residue
removal efficiency is a function of the combination of, and interaction
between, the container variable(s) and the formulation variable(s)
(Refs. 10, 11, 29 and 65). A performance standard approach would not
seek to achieve residue removal efficiency through the prohibition of
certain container types or formulation characteristics that do not
facilitate residue removal, nor would it require the use of a limited
set of container types that have been shown to not retain residues;
rather, a performance standard would consider the residue removal
efficiency of the container and formulation in combination.
EPA believes the establishment of a laboratory performance standard
is the most desirable strategy, as it provides registrants the greatest
amount of flexibility to achieve the standard. A registrant could
modify or change the variables of container design and/or formulation
characteristics as the registrant so chooses, as long as the
performance standard is met.
By setting a laboratory performance standard, EPA is laying the
groundwork for effective residue removal at the user level. When
effective residue removal is fostered by container designs and
formulations in conjunction with proper container cleaning procedures,
EPA believes that containers will be more readily accepted by pesticide
container recycling and collection programs, and by municipal solid
waste facilities.
EPA believes that promulgation of this proposed laboratory
performance standard will:
(1) Encourage the use of containers with design features that
facilitate residue removal.
(2) Encourage the use of formulations that facilitate residue
removal.
(3) Help to assure those involved with the disposition of the
pesticide containers (i.e., farmers, landfill operators, recyclers,
etc.) that the containers can be cleaned adequately.
(4) Discourage or eliminate those container/formulation
combinations that are known to cause problems.
b. Rigid/dilutable category targeted for proposed performance
standard. At this time, EPA is proposing to establish a residue removal
performance standard and laboratory residue removal testing procedures
for one type of container/ formulation combination. That container/
formulation combination includes rigid containers with pesticides that
are required or allowed by the label or labeling to be diluted prior to
application (referred to as ``rigid/dilutable''). By ``rigid
containers,'' EPA means containers that have definite retained shape
and form and that are self-supporting. EPA is not aware of any
regulatory definitions of rigid in DOT regulations or in U.N. packaging
standards. For the purposes of subpart F, rigid containers would
include containers constructed of metal, molded polyethylene, glass,
and paperboard (cardboard). Rigid containers would also include bag-in-
a-box containers, because the box is an integral part of the package
and bears the label, and the bag or bladder is considered a liner. The
bag/bladder liner can and should be rinsed prior to disposal. Water-
soluble packages, containing dilutable pesticide, that are sold in
cardboard tubes, boxes, or other packaging types would not be
considered rigid containers for the purposes of these regulations. The
water-soluble film is not a liner and cannot be rinsed because it
dissolves to become part of the spray mix. Removal of pesticide
residues should not be necessary for the outer packaging because the
pesticide is contained within the water soluble packages. EPA requests
comments on the proposed description of ``rigid container.''
c. Future inclusion of other categories. EPA ultimately intends to
set performance standards for other container/formulation categories.
The categories may include non-rigid containers with dilutable and non-
dilutable pesticide, rigid containers with non-dilutable pesticide, and
aerosols. Standards would be based on what is practicable for the
specific type of container and what residue removal procedure is
appropriate for the container/formulation combination. Data on residue
levels for these categories are being investigated. For example, EPA
and the Paper Shipping Sack Manufacturers Association (PSSMA) conducted
a study of the residue in paper bags (Ref. 61).
d. Rigid/dilutable performance standard. EPA is proposing in
Sec. 165.104(b) to establish a residue removal performance standard
that represents a practicable level of residue removal for the majority
of container/formulation combinations currently in use, based on data
available to EPA. To achieve this goal, the proposal would establish a
standard through the utilization of a standardized triple rinse
procedure, and would require that a minimum of 99.9999 percent removal
of pesticide active ingredient be achieved, expressed in terms of
reduction of concentration of the pesticide in the residue. In setting
the standard, EPA evaluated the residue data produced using a
standardized triple rinse methodology. The data analysis indicates that
a 99.9999 percent removal standard is practicable for the majority
(approximately 70 percent) of rigid/dilutable products tested. The
Report to Congress (Ref. 65) examines the container and formulation
characteristics that may have resulted in inefficient removal of
residues for these products.
EPA is proposing that registrants be responsible for assuring that
each rigid nonrefillable container design type and dilutable pesticide
formulation combination meets the 99.9999 percent residue removal
performance standard before the sale or distribution of the pesticide
product would be permitted.
EPA has gathered a number of studies of the efficiency of triple
and/or pressure rinsing. These studies used a variety of protocols and
rinsing procedures, making it difficult to compare their results. These
documents are included in the docket as background information (Refs.
1, 3, 14, 25, 30, 31, 39, 51, 59).
Several different dilutable formulation types in rigid containers
with capacities ranging from 1 pint to 5 gallons were tested according
to a procedure developed by EPA. The data are summarized in the
following Tables 1 and 2 below. In Table 1, 70 percent of the
agricultural pesticide products tested met the standard of 99.9999
percent removal, while 86 percent achieved 99.999 percent removal. EPA
believes that the container/formulation types tested and presented in
Table 1 (including plastic and metal containers ranging from 1 pint to
5 gallons) are representative of pesticide products for the
agricultural industry.
Table 1.-- Laboratory Standard - Agricultural Products Data Summary.\1\
----------------------------------------------------------------------------------------------------------------
Total Number Meeting 6- Percent Meeting 6- Number Meeting 5- Percent Meeting 5-
Formulation type Number\2\ 9's\3\ 9's 9's\4\ 9's
----------------------------------------------------------------------------------------------------------------
Dry flowable........... 1 1 100 1 100
Emulsifiable
concentrate........... 20 15 75 18 90
Aqueous solution....... 3 2 67 3 100
Flowable liquid........ 15 10 67 12 80
Encapsulated........... 4 2 50 3 75
----------------------------------------------------------------------------------------
Total............. 43 30 70 37 86
----------------------------------------------------------------------------------------------------------------
\1\ This summary is based on data generated in 1990 by an EPA contractor and the National Agricultural Chemicals
Association (NACA). The data are in the Report to Congress (Ref. 65). The procedure followed was a well-
defined, thorough, laboratory triple rinse.
\2\ The total number of different container/formulation combinations for a given formulation type.
\3\ The number of different container/formulation combinations that would meet a standard of 99.9999 percent
residue removal (6-9's). Note: container/formulation combinations that were tested in triplicate were
considered to meet the standard only if all three data points met the standard.
\4\The number of different container/formulation combinations that would meet a standard of 99.999 percent
residue removal (5-9's). Note: container/formulation combinations that were tested in triplicate were
considered to meet the standard only if all three data points met the standard.
In Table 2 below, 59 percent of the containers representative of
the industrial, institutional and residential markets that were tested
met the standard of 99.9999 percent removal, while 89 percent achieved
99.999 percent removal. EPA believes the container types tested
(plastic and metal containers ranging from 1 pint to 5 gallons) are
representative of these industries.
EPA has received residue removal data from the Chemical Specialties
Manufacturers Association (CSMA) on containers and formulations that
CSMA claims are representative of household and institutional products
(Ref. 77). This information indicated that 2 of the 12 container/
formulation combinations tested would meet a standard of 99.9999
percent removal. These preliminary results do not appear to be
consistent with the data in Table 2. EPA requests comments, including
additional data, on whether household and institutional pesticide
container/formulation combinations have different characteristics than
agricultural pesticide containers/formulations or whether there are
specific reasons for the difference in percentages meeting a standard
of 99.9999 percent such as a smaller sample size in the CSMA testing.
Table 2 reads as follows:
Table 2.-- Laboratory Standard - Industrial, Institutional, and Household Products Data Summary\1\
----------------------------------------------------------------------------------------------------------------
Total Number Meeting 6- Percent Meeting 6- Number Meeting 5- Percent Meeting 5-
Number\2\ 9's\3\ 9's 9's\4\ 9's
----------------------------------------------------------------------------------------------------------------
Formulation type
Emulsifiable
concentrate......... 9 8 89 9 100
Flowable liquid...... 9 1 11 6 67
Encapsulated......... 9 7 78 9 100
----------------------------------------------------------------------------------------
Total.............. 27 16 59 24 89
----------------------------------------------------------------------------------------
Container size
1 gallon............. 9 5 56 8 89
Less than 1 gal...... 18 11 61 16 89
----------------------------------------------------------------------------------------
Total.............. 27 16 59 24 89
----------------------------------------------------------------------------------------------------------------
\1\This is based on data generated in 1991 by an EPA contractor. The procedures followed was a well-defined,
thorough, laboratory triple rinse.
\2\ The total number of different container/formulation combinations for a given formulation type or container
size range.
\3\ The number of different container/formulation combinations that would meet a standard of 99.9999 percent
residue removal (6-9's). Note: container/formulation combinations that were tested in triplicate were
considered to meet the standard only if all three data points met the standard.
\4\ The number of different container/formulation combinations that would meet a standard of 99.999 percent
residue removal (5-9's). Note: container/formulation combinations that were tested in triplicate were
considered to meet the standard only if all three data points met the standard.
EPA believes that the most straight forward method of measuring the
amount of accessible pesticide is to perform the test on a container
that has been -properly cleaned using a standardized triple rinse
procedure. After completion of a triple rinsing procedure, an
additional rinse of the container (i.e., a fourth rinse) would be
performed and the concentration of pesticide active ingredient in the
fourth rinse would be determined.
The rigid/dilutable performance standard being proposed would
require that, at a minimum, a 99.9999 percent reduction of active
ingredient concentration in the fourth rinse must be achieved. A
99.9999 percent removal of pesticide from the container is achieved if
the concentration of active ingredient in the fourth rinse is less than
or equal to 0.0001 percent of the pesticides' original active
ingredient concentration. Based on data available to EPA, this percent
removal standard represents a practicable level of residue removal for
the majority of rigid/dilutable containers currently in use. EPA
believes that this standard is preferable to a lower standard (e.g.,
99.999 percent removal) because it would provide for a reasonable
degree of improvement in the level of residue removal achievable by the
currently most inefficient container/ formulation combinations.
The purpose of measuring the concentration of pesticide in the
fourth rinse is to measure the pesticide that is readily accessible
after a triple rinse. This procedure does not measure the total amount
of pesticide left in the container after a triple rinse, because it
does not include the total amount of pesticide that remains trapped in
the container. Small amounts of pesticide can be adsorbed on and/or
absorbed into the container (Ref. 65).
In order to measure conformance to the residue removal performance
standard, Sec. 165.104(b)(1) proposes that the rigid/dilutable residue
removal methodology set out in Sec. 165.106 must be followed. The
residue removal test methodology is a triple rinse procedure with an
additional rinse (fourth rinse) that is conducted under strictly
controlled laboratory conditions. EPA developed the methodology through
the testing of representative rigid/dilutable products. Some of the
test parameters, such as the drain and shake times and the quantity of
water used, were based on triple rinse procedures common in many
current State regulatory definitions of triple rinsing. Section
165.104(b)(2) proposes that the testing would have to be conducted in
accordance with the Good Laboratory Practice Standards (GLP) at 40 CFR
part 160.
EPA developed the testing and analysis methodologies to provide
standardized, uniform, and controlled testing of compliance. In the
testing and analysis methodologies, EPA has set out the specific
testing elements and standards (such as water temperature) that EPA
believes are critical to the accurate determination of residue
quantities. EPA plans to issue ``Nonrefillable Container Residue
Removal Methodologies: Rigid Containers and Dilutable Pesticide'' in
EPA's Pesticide Assessment Guidelines, which will give more detailed
information on the methodologies (such as the recommended orientation
of the container during the shaking and the draining periods).
As part of the general testing methodology, EPA would impose a
statistical performance standard to ensure that a specified percentage
of containers meet the residue removal performance standard with a
predetermined level of confidence. A minimum testing of 19 different
containers would be required to ensure with reasonable confidence that
the container/formulation combination meets residue removal performance
standard. This approach employs an adaptation of a statistical model
used in setting ``Tolerance Limits'' for performance criteria (Ref. 8).
For pesticide formulations with more than one active ingredient,
the registrant would have to calculate the percent removal for each
active ingredient, and each active ingredient must meet the residue
removal standard.
EPA is aware that several different nonrefillable container design
types, as defined in proposed Sec. 165.3, may be used with one
registered pesticide product (EPA registration number). The regulations
would require compliance with the residue removal standard by each
nonrefillable container design type that is used with each registered
pesticide product. Separate tests must be completed for each
nonrefillable container design type and registered pesticide product
combination. EPA requests comment on the proposed requirement that all
rigid nonrefillable design types used for each registered pesticide
product must meet the residue removal standard.
EPA requests comments on the reasonableness of the residue removal
performance standard as applied to all dilutable pesticide packaged in
rigid containers, including types of containers or pesticides for which
a different standard may be appropriate, and on alternatives to the
proposed standard.
EPA believes that a large percentage of products can meet the
residue removal standard, and those that do not initially meet this
standard may require only a modification of container design in order
to comply. Larger nonrefillables, such as drums, may have difficulty
meeting the residue removal standard.
EPA considered requiring testing at specified intervals during
production to ensure continued compliance with the residue removal
performance standard, but elected not to propose such a requirement
because it did not seem necessary. While the regulations would not
prohibit production testing, the registrant would be responsible for
all of his product meeting the residue removal performance standards.
EPA recognizes that registered pesticide products containing small
quantities of active ingredient may encounter difficulties in
documenting a 99.9999 percent reduction of active ingredient
concentration. Although current laboratory equipment can detect very
small concentrations of chemicals, there are detection limitations.
When a residue removal procedure is performed on a pesticide product
that contains a small initial concentration of active ingredient, the
active ingredient concentration in the rinsate could fall below the
detection capability of typical laboratory equipment.
EPA considered establishing different criteria for those pesticide
products where the detection of active ingredient concentration in the
fourth rinse (as set out in the proposed methodology) would exceed
currently available detection limits. One approach considered was to
presume that products with active ingredients that are undetectable
after the fourth rinse using approved analytic techniques meet the
99.9999 percent removal standard. Another approach that was considered
was to exempt all products that contain active ingredient less than a
certain concentration.
EPA did not propose these approaches because of insufficient
information about how concentration of undetectable amounts of the
active ingredient relates to residue risk and due to concerns that
other chemical components of a product's formulation may hinder active
ingredient removal to such an extent that it can be determined that the
product does not meet the proposed 99.9999 percent removal standard.
EPA requests comments on the exemption of products with low initial
active ingredient concentrations or the establishment of alternative
residue removal standards for products with low initial active
ingredient concentrations (other than the proposed 99.9999 percent
residue removal standard). EPA also solicits comments on how to address
setting detection limits for these products.
EPA considered, but decided not to propose, an exemption from the
residue removal standard for household use (residential use) pesticide
products. FIFRA section 19(f)(1)(C) states: ``The Administrator may, at
the discretion of the Administrator, exempt products intended solely
for household use from the requirements of this section.'' However, EPA
is proposing to require rigid/ dilutable household use pesticides to
comply with the residue removal standard because many of these products
are the same formulation, contain the same active ingredient
concentration, and are sold in the same package size as pesticide
products used in agricultural, industrial, institutional, and other
commercial markets. Additionally, even if a product is packaged or
formulated differently for household use than for other uses, it may
still pose residue removal concerns. EPA believes it may not be
reasonable to exempt products from the proposed residue removal
standard just because they are purchased by household users when they
may pose residue removal concerns the same as, or similar to, non-
household use products.
EPA recognizes that there are instances where the risks of human
and environmental exposure from pesticide residues remaining in
containers may be reduced because of a household or other pesticide
product's low active ingredient concentration and low toxicity. EPA
requests comments on the inclusion of all household use pesticides in
the residue removal requirement, including alternative residue removal
standards for low active ingredient concentration and low toxicity
household use products, as well as how to regulate products sold to
commercial and household users with essentially the same net content.
EPA also solicits comment on how ``household use'' would be defined for
purposes of exempting them. In addition, many household use products
have dual uses in that they can be diluted or used at full strength.
EPA solicits comments on whether such products should be considered
dilutable for the purposes of the rule.
EPA is proposing to allow a waiver of the residue removal
requirement under certain circumstances. A registrant could submit a
request to EPA to have the residue removal requirement waived for a
pesticide product packaged in nonrefillable containers. The waiver
proposed in Sec. 165.104(c) is a general standard to accommodate the
circumstances under which EPA would grant a waiver from the residue
removal standard. EPA is considering several criteria on which to base
the evaluation of a waiver request, such as whether a registrant can
show that a waiver is necessary for reasons of practicality or
feasibility or if a registrant can show that the pesticide residues in
the container would not present an unreasonable risk to humans or the
environment. EPA requests comments on criteria that would be
appropriate to use to evaluate waiver requests. Because EPA's intent in
establishing a residue removal standard is to reduce human and
environmental risk from pesticide residues, as well as facilitate the
reuse and disposal of pesticide containers, EPA believes that a waiver
based on no unreasonable risk to humans or the environment would be
appropriate.
EPA requests comments on the following examples of circumstances in
which a waiver could be granted:
(1) The registrant can use validated modelling techniques based on
the concentration of active ingredients to show that residue levels
after triple rinsing would result in very low or undetectable residue
levels.
(2) The registrant can show that even before triple rinsing the
active ingredient in question is low in toxicity and is present in low
concentrations.
(3) The registrant performs the required triple rinse tests and the
resulting residues are undetectable with the use of approved analytic
techniques.
(4) The registrant has established a returnable container program
that collects from users all empty containers of the noncomplying
product. Before granting a waiver, EPA would encourage the registrant
to switch to smaller nonrefillable containers or refillable containers,
as described in subpart G of this proposal. EPA also requests comment
on whether there are other circumstances in which a waiver from the
residue removal requirement should be granted.
e. Other options considered. EPA considered several other possible
options for addressing pesticide residue removal before finally
electing to propose a laboratory performance standard. Those options
included: (1) Prohibiting certain container design features or
formulation characteristics that have been proven to exhibit
unacceptable cleaning efficiencies, (2) requiring certain container
designs that have been proven to exhibit acceptable cleaning
efficiencies, and (3) developing residue removal standards according to
EPA's established pesticide toxicity categories. EPA requests comments
on these options and on other alternatives that would achieve the goals
set out in this proposal.
EPA does not propose to regulate technical design characteristics
of containers or formulation characteristics, as would be required in
options 1 and 2, for the following reasons: (1) Not all variables of
residue removal would be addressed, (2) technology advances rapidly,
rendering some design features obsolete and introducing others, (3)
flexibility to the regulated community is reduced, (4) EPA does not
have sufficient data supporting benefits or advantages/disadvantages of
one design feature over another, and (5) some features offer benefits
in other areas that affect their disadvantages for residue removal (for
example, while hollow handles on plastic jugs tend to retain pesticide,
they also facilitate pouring without glugging).
EPA elected not to develop residue removal standards according to
EPA's existing categorization of pesticide toxicity [Sec. 156.10(h)(1)]
because the toxicity categories are primarily based on the risks of
pesticide exposure to humans. EPA's intent in establishing a residue
removal standard is to reduce environmental, as well as human exposure
to residues remaining in pesticide containers, and the toxicity
categories do not factor in environmental risks. EPA requests comments
and suggestions on a strategy that could be used to develop residue
removal standard(s) based on pesticide toxicity.
f. User conformance in the field to the laboratory performance
standard is not required. EPA emphasizes that the laboratory residue
removal performance standard of 99.9999 percent removal is not an
enforcement standard that would be used in the field to check on user
compliance with container cleaning instructions set out on the label.
The proposed performance standard would apply only to registrants.
Users would be required to follow the residue removal procedure(s)
specified on the label, as discussed in the proposed amendments to 40
CFR part 156. EPA believes the proposed performance standard should
ultimately help users clean containers because certain container design
and formulation variables affecting residue removal efficiency will be
eliminated. By designing container/formulation combinations that rinse
clean to at least a certain minimum level, registrants will increase
the likelihood of effective residue removal in the field, even if
conditions in the field vary from controlled laboratory conditions.
EPA intends to investigate the establishment of field residue
removal enforcement standard(s) to measure user compliance with the
residue removal label instructions. Options that may be appropriate
methods of establishing a field standard include:
(1) Adopting the residue removal laboratory performance standard
that EPA is proposing to establish for each container/ formulation
combination (99.9999 percent removal for rigid/ dilutables). One issue
with this option is the possible difficulty users would have in meeting
the standard in the field. The laboratory testing would be performed
under strictly controlled conditions, whereas field conditions are
highly variable and in many cases are out of the control of the user
(e.g., water temperature, pH, salinity, etc. may effect the solubility
of certain formulations in water).
(2) Setting a performance standard less than the laboratory
standard. One issue with this option is that it might not be a
reasonable measure of user compliance because EPA does not have
sufficient information or data to determine whether this standard is
achievable under a wide variety of field conditions.
(3) Requiring registrants to set the field standard for their
pesticide products and submit the data used to support the standard.
One issue with this option is the determination of the methods and
tests that registrants would be required to submit. Registrants may be
unwilling to set a stringent field standard because of potential
liability for user compliance.
EPA believes it may be appropriate to defer the establishment of a
field enforcement standard until more information about the benefits
and advantages/disadvantages of such a standard are identified. EPA
requests comments on whether to establish field enforcement
standard(s).
8. Certification requirements. Section 165.111 proposes to require
that all registrants who package pesticide in nonrefillable containers
submit a certification stating that the container design and residue
removal standards of proposed Sec. Sec. 165.102 and 165.104 have been
met. A certification would be required for each registered pesticide
product (i.e., each EPA registration number), and the stated compliance
must be true for each container design type that is used with the
registered pesticide product.
Section 165.111(b) proposes that a certification be submitted for
all currently registered pesticide products, as well as new pesticide
products. Section 165.111(c) specifies that the contents of the
certification must include basic information about the registrant and a
statement that the registrant is in compliance with the appropriate
sections of subpart F.
The certification would be based on tests and documentation. The
information provided in the certification will identify the pesticide
product and allow EPA to check compliance with the requirements of
Sec. Sec. 165.102 and 165.104. Under the proposed Sec. 165.114, EPA may
perform inspections, and/or require submission, of the data or records
required to be maintained in Sec. 165.114. For example, if EPA knows
that a particular container/formulation combination has difficulty
achieving the residue removal standard, then registrants who submit
applications for registration of a pesticide product with this
container/formulation may be required to submit the data they are using
to support the certification.
9. Recordkeeping and inspections. Section 165.114 proposes to
require that registrants maintain certain records showing compliance
with subpart F for as long as the nonrefillable container design type
is used with the pesticide formulation and for 3 years thereafter. The
records would be available for EPA (or its authorized representative)
or States for inspection and copying, but would have to be submitted to
EPA only if EPA specifically requested their submission from the
registrant.
The records proposed to be kept are as follows:
(1) Section 165.114(a) and (b). A copy of the certification
statement and some basic information identifying the pesticide product.
(2) Section 165.114(c). Records showing compliance with the
container dispensing capability requirements of Sec. 165.102(d),
including documentation of any testing performed. The test data or
documentation could include data generated through a testing method or
photographic evidence that demonstrates dispensing capability.
(3) Section 165.114(d). Records showing compliance with the
standardized closure requirements of Sec. 165.102(e). In ordering and
purchasing containers from a container supplier, the registrant could
require the proposed closure design specifications in the purchase
contract. Alternatively, the container supplier may have literature
demonstrating that a certain container design type conforms to the
proposed specific closure design specifications, or may provide
relevant information or data in a letter to the registrant.
(4) Section 165.114(e). Records showing compliance with the residue
removal requirements of Sec. 165.104, including documentation or
testing.
EPA anticipates that many pesticide products will not require
residue removal testing to determine compliance with the residue
removal standard because registrants will acquire data that is
acceptable to EPA from other registrants and sources. Section
165.114(e)(1)(ii) would allow a registrant to use residue removal test
data that have been generated for a different pesticide product. The
registrant may demonstrate that a product shares the same formulation
characteristics as the one that has met the residue removal standard,
and is packaged in the same container that has been documented as
meeting the standard with this type of formulation. The registrant
would be required to submit a written explanation of why the data for
the other pesticide product should be allowed to substitute for data
that would otherwise be generated for his pesticide product. EPA
requests comments on the circumstances under which submission of
residue removal data from pesticide products with substantially similar
container/formulation characteristics would be sufficient in lieu of
data generation for every pesticide product. EPA also requests comments
on the factors to be considered in determining when container and
formulation characteristics should be considered ``substantially
similar'' for the purposes of this requirement.
Section 165.114(e)(1)(iii) would allow the registrant to submit a
letter from the facility or the container manufacturer that conducted
the testing to provide the registrant with some flexibility. The
letters would be required to contain information about the specific
test type, a description of the container, a description of the
pesticide formulation, and the test results, as well as specify the
location of the original test data.
EPA reserves its right, on a case by case basis, to require the
registrant to submit the residue removal data. The certification that
the container/formulation combination meets the residue removal
standard, having been tested by the proposed methodology, is
information that would be required to be submitted under FIFRA section
19. The certification, as well as the underlying residue removal data,
are data necessary to maintain a registration under FIFRA section 3. If
the registrant has only a letter from the testing facility in its
records instead of the actual residue removal data as would be allowed
by Sec. 165.114(e)(1)(iii), the registrant would be responsible for
assuring that it could obtain the data so that it could submit the data
to EPA, if required to do so.
Testing must be conducted in accordance with the Good Laboratory
Practice Standards (GLP) at 40 CFR part 160. Section 160.15 requires
the testing facility to permit an authorized employee or duly
designated representative of EPA to inspect and copy the test data, at
reasonable times and in a reasonable manner. If the facility denies EPA
access to the test data, EPA would not consider the data to be reliable
for purposes of supporting the registration.
Proposed Sec. 165.114(e)(2) would specify that the registrant would
have to keep a statement of compliance or noncompliance with respect to
GLP, as described by 40 CFR 160.12, with the residue removal records.
Section 160.12 requires a statement of compliance or noncompliance to
accompany all testing and studies submitted to EPA. However, the
proposed 40 CFR part 165 regulations would not require registrants to
submit data as a routine practice; registrants would only have to keep
the residue removal data or related documentation in their records.
Therefore, EPA believes that it is appropriate to require registrants
to keep a copy of the GLP statement of compliance or noncompliance with
the residue removal data.
EPA is considering requiring registrants to submit the GLP
statement of compliance or noncompliance to EPA as part of the
certification in Sec. 165.111. Receiving the GLP compliance statements
would provide EPA with information that could be helpful in determining
which data to request registrants to submit. In addition, the GLP
compliance statements would give EPA a list of the laboratories that
have done the residue removal testing, so the laboratories could be
inspected. EPA requests comments on whether the GLP statement of
compliance or noncompliance should be kept with the residue removal
records as proposed, or submitted to EPA.
10. Compliance dates. In section 19(e) of FIFRA, Congress directed
EPA to promulgate container design regulations by December 24, 1991 and
required compliance with these regulations by December 24, 1993.
However, the compliance dates in the statute no longer apply directly
because EPA did not meet the statutory deadline for promulgating the
final rule. EPA is therefore proposing in Sec. 165.117(a) to provide a
period of 2 years after the date of publication of the final rule in
the Federal Register before registrants would have to be in compliance
with subpart F. As a matter of policy, EPA believes some lead time is
necessary for compliance with these regulations, and a 2-year
implementation period would provide adequate time for registrants to
perform the testing and analysis necessary to comply with the
requirements of subpart F. Additionally, 2 years reflects the time
frame established in the statute. EPA does not believe Congress would
have intended to impose major additional compliance burdens on the
regulated community as a result of EPA's delay in issuing this rule.
Accordingly, EPA believes it is reasonable to provide a compliance date
of 2 years after the date of publication of the final rule in the
Federal Register. All pesticides sold or distributed by registrants in
nonrefillable containers would have to be in compliance at that time.
Proposed Sec. 165.117(c) would specify that certifications for
pesticide products registered as of the date of publication of the
final rule would be required to be submitted to and received by EPA
within 2 years after the date of publication of the final rule in the
Federal Register.
In addition, EPA is proposing in Sec. 165.117(b) that as of 5 years
after the date of publication of the final rule in the Federal
Register, persons other than registrants may only sell or distribute
pesticide packaged in nonrefillable containers that are in compliance
with the requirements of subpart F. Persons other than registrants
include, but are not limited to, dealers, retailers, grocery and pet
stores, veterinarians, garden centers, and merchandise catalog
companies.
11. Waiver requiring EPA approval. Section 165.119 contains the
procedures to be followed when applying for exemption from the
standardized closure requirement of Sec. 165.102(e) of subpart F.
Section 165.119(a) would specify the general information that must
accompany the requests and directions on where to submit the requests.
Section 165.119(b) would specify the general information that must
accompany the request for an exemption from the requirements for
standardized closures of Sec. 165.102(e) of subpart F.
V. Refillable Container Standards: Container Design and Residue
Removal
A. Background
This proposal would revise 40 CFR part 165 to facilitate the safe
refill, reuse, and disposal of refillable containers by establishing
container design criteria and refilling responsibilities and practices.
Refillable containers are most commonly used in the agricultural
pesticide market, but are also used in industrial and institutional
applications and by pest control operators. Refillables come in a
variety of types and shapes, ranging from 15-gallon ``keg-like''
containers called small volume returnables to huge, 12,000-gallon
stationary storage tanks.
Portable refillable containers, generally larger than 100 gallons,
were introduced into the agricultural pesticide industry in the late
1970s and early 1980s. Fostered by EPA's Bulk Pesticides Enforcement
Policy which, under certain conditions, allowed repackaging without a
registration for the repackaged product, the use of these containers at
first grew exponentially. Although the rate of growth has slowed, the
use of these portable refillable containers continues to grow. A
National Agricultural Chemicals Association (NACA) survey showed a 3
percent increase in liquid capacity sold in minibulks between 1988 and
1989, with a similar increase projected for 1990 (Ref. 18).
The use of minibulks is most common in the Midwest and other
regions where many acres of the same crop are farmed. It has been
predicted that the use of minibulks will continue to increase for
several years and level off when most of the potential monoculture crop
markets have been tapped. This may be occurring already, because
relatively few users need 100 or more gallons of a pesticide product at
any one time.
The problems and concerns associated with the use of refillable
containers are different from nonrefillable container problems such as
spilling, leaking, and splashing because pesticide transfer equipment
is generally an integral part of refillable containers. Pesticide
product usually is pumped from a refillable container, forming a closed
or semi-closed system, instead of being poured from the container, as
often occurs with nonrefillables. The two major concerns posed by
refillable containers are the potential for a large release of
pesticide and the possibility of contamination of the product being
sold or distributed in the refillable containers. Large releases of
pesticide to the environment can contaminate surface and ground water
and sensitive habitats. Contaminated product could cause crop damage,
illegal tolerances, and possibly unhealthy exposure. A more thorough
examination of the current practices and problems associated with
using, cleaning, and disposing of refillable containers can be found in
the Report to Congress (Ref. 65).
B. Today's Proposal
Subpart G of the proposed part 165 regulations contains the
refillable container standards, which can be categorized into two major
types: container design standards and procedural requirements for
refilling. The design standards describe the minimum design and
construction requirements that EPA believes are necessary for the safe
use and reuse of refillable containers. The refilling requirements set
out the responsibilities of both registrants and refillers. These
refilling requirements include the procedures and practices that EPA
believes are necessary for refillers to follow to ensure the safe
refill and reuse of these containers.
EPA considered three different regulatory options for subpart G.
The options differ mainly in the designation of parties who would be
responsible for the containers meeting the design standards. The option
proposed in the regulatory text, option 1, would make the registrants
responsible for containers meeting the container design standards. The
general philosophy of the three options and a detailed description of
each are presented in Unit V.B.8 of this preamble.
The definition section of proposed subpart A contains definitions
of terms used in proposed subpart G and in related subparts of today's
proposal. Terms that are key to the understanding of subpart G include:
(1) Container.
(2) Design type.
(3) Dry bulk container.
(4) Dry minibulk container.
(5) Liquid bulk container.
(6) Liquid minibulk container.
(7) One-way valve.
(8) Refillable container.
(9) Refiller.
(10) Repackage.
(11) Tamper-evident device.
(12) Transport vehicle.
1. Scope and applicability. Section 165.120 would cover the scope
of subpart G, which would set forth design and construction standards
for refillable containers and would establish standards and
requirements for refilling such containers.
Section 165.122 would describe the applicability of the subpart G
regulations. The subpart in general would apply to three different
entities: (1) Registrants who distribute or sell a pesticide product to
refillers for repackaging into refillable containers, (2) registrants
who distribute or sell a pesticide product in refillable containers
(i.e., registrants who are refillers), and (3) refillers. As described
below, however, different sections of subpart G would apply to specific
subgroups of these three categories.
Registrants are divided into two categories to distinguish between
the two scenarios for repackaging pesticide into refillable containers.
In the first and more common situation, registrants distribute or sell
product to refillers, generally in large, undivided quantities, and the
refillers transfer the product into smaller refillable containers that
go to the end user. In the second situation, the registrant packages
the product directly into a portable refillable container that is then
distributed or sold by a refiller or dealer to the end user, or the
registrant delivers its pesticide product directly to the end user's
bulk tank. In either of these situations, the registrant is the
refiller. The key to the distinction is the party who actually
transfers the pesticide product into the refillable container.
The container design and construction standards and requirements of
Sec. Sec. 165.124, 165.126, and 165.128 would apply to: (1) Registrants
who distribute or sell pesticide product to refillers that, in turn,
repackage the product into refillable containers, and (2) registrants
who distribute or sell pesticide product in refillable containers. Unit
V.B.8 of this preamble discusses in detail the reasons EPA is proposing
to hold registrants solely responsible for compliance with the
container design standards and how refillers can determine that
refillable containers comply with these standards.
The standards and requirements in Sec. 165.129 would apply to
registrants allowing transfer of their registered pesticide product
into refillable containers by refillers for distribution or sale.
Section 165.130 would establish the responsibilities of registrants
in terms of the refilling of refillable containers. Section 165.132
would prescribe related recordkeeping requirements.
Sections 165.134 and 165.136 would establish comparable
responsibilities, procedures, and recordkeeping for refillers.
Section 165.139 would establish a compliance date for the
requirements to be met by all registrants and refillers.
Several general exemptions would be included in Sec. 165.122(b).
Subpart G would not apply to containers that contain manufacturing use
products or to transport vehicles that contain pesticide.
Similar to subpart F (see Unit IV.B.1 of this preamble), EPA is
proposing to exclude manufacturing use products from subpart G because
EPA has a limited amount of information on the kinds of containers used
for manufacturing use products and the problems with these containers.
EPA requests comments and information on the problems, handling
practices, and disposal of manufacturing use product containers. As
with subpart F, EPA is strongly considering expanding the applicability
of subpart G in the final rule to include manufacturing use products.
EPA's ``Enforcement Policy Applicable to Bulk Shipments of
Pesticides'' (Ref. 63) dated July 11, 1977 and the subsequent amendment
to the policy dated March 4, 1991 (Ref. 62) apply to manufacturing use
products as well as end use products. EPA intends to rescind the Bulk
Pesticides Enforcement Policy when subpart G goes into effect. As a
result, manufacturers and distributors that are not registrants of a
manufacturing use product would no longer be able to repackage that
manufacturing use product for distribution or sale under the terms of
the Bulk Pesticides Enforcement Policy. EPA is unsure of the extent to
which registrants currently are allowing other manufacturers or
distributors to sell or distribute their manufacturing use products
under the terms of the Bulk Pesticides Enforcement Policy. Therefore,
EPA is uncertain about the potential effect of the proposed regulations
on manufacturing use products. EPA welcomes comments on the impact that
exclusion from subpart G would have on the distribution of
manufacturing use products.
The other exclusion in subpart G is for transport vehicles that
contain pesticide. Without the exemption, transport vehicles would be
subjected to the requirements of subpart G because they would be
included in the proposed definition of refillable container (see
subpart A). However, EPA does not intend to address the design of
transport vehicles.
EPA's intent with the provision in proposed Sec. 165.122(b)(2) is
to exempt transport vehicles with pesticide-holding tanks that are an
integral part of the transport vehicle and that are the primary
containment for the pesticide. For example, EPA would like to exclude
tank cars and tank trucks used in the distribution of bulk pesticides
from the container design standards of this subpart. However, EPA is
concerned that there are situations where the distinction between a
container and a transport vehicle may not be clear. For example, EPA is
aware that pesticide product may be sold or distributed in minibulk
containers on small trailers. In this case, EPA would consider the
vessel to be a container and therefore subject to the standards of this
subpart. EPA requests commenters to describe other examples of unusual
container and/or transport vehicle situations that may cause confusion
regarding the transport vehicle exclusion in Sec. 165.122(b)(2).
2. Container design standards. Section 165.124 proposes container
design standards for refillable containers. EPA is concerned about the
structural integrity, strength, and durability of refillable
containers. During repeated refill and reuse, refillable containers may
be subjected to rough conditions, such as being dropped, bumped, left
in the sunlight, or subjected to temperature extremes. Even under the
best circumstances and the most careful handling, a certain amount of
``wear and tear'' is expected. Therefore, EPA believes that refillable
containers should have a minimum degree of integrity to provide for the
safe use, reuse, and refill of these containers.
Proposed Sec. 165.124(a)(1) would prohibit the distribution or sale
of a pesticide product in a refillable container unless the container
meets the standards of Sec. 165.124. Therefore, a container could not
be refilled with a pesticide product for distribution or sale unless it
met the standards required by this section. Refillable containers in
which pesticide product is distributed or sold would include minibulk
containers and bulk containers at refillers. As also specified in
Sec. 165.124(a)(1), the registrant would be responsible for assuring
that the refillable containers in which the registrant's product is
distributed or sold meet the standards of this section.
Section 165.124(a)(2) would state that information on container
failures or other incidents involving pesticide containers that may
result in releases of pesticide may be reportable by registrants under
FIFRA section 6(a)(2). This requirement is the same as that in
Sec. 165.102(a)(2) for nonrefillable containers.
As discussed in Unit IV.B.2 of this preamble, EPA is relying on
market forces to ensure that dealers and refillers notify registrants
of container failures and similar incidents. As a matter related
specifically to refillable containers, EPA expects that refillers would
notify registrants of failures of any container that the registrant has
identified as acceptable under proposed Sec. 165.130(b)(2), and not
just the containers that the registrant owns.
Proposed Sec. 165.124(a)(3) would clarify that compliance with the
proposed part 165 regulations would not be an exemption from DOT's
potentially applicable Hazardous Materials Regulations (HMR) at 49 CFR
parts 171 through 180. The same provision is proposed in
Sec. 165.102(a)(3) for nonrefillable containers. If a pesticide is a
DOT hazardous material, the pesticide would be required to be packaged
in compliance with both DOT and EPA regulations. For specific proposed
part 165 requirements that may overlap with DOT requirements, such as
some of the permanent marking requirements and the drop test, EPA is
proposing that compliance with the DOT requirement would satisfy the
part 165 requirements. Such compliance would prevent duplicative
standards or testing.
3. Permanent marking. Section 165.124(b) proposes permanent marking
of certain information on refillable containers. The markings would
provide information to the user and refiller; facilitate the safe
reuse, handling, and disposal of the container; and facilitate
enforcement of the regulations. Permanent marking means the same thing
as it does for nonrefillable containers, although EPA anticipates that
different permanent marking methods will be used depending on the
container type, as discussed in Unit IV.B.4 of this preamble.
EPA is proposing that the following information be permanently
marked on each refillable container: (1) The name of the container
manufacturer, (2) the model number assigned to the design type of the
container, preceded by the phrase ``Model No.:'', (3) the month and
year (last two digits) of manufacture of the container, (4) the rated
capacity of the container, in appropriate units of weight or volume,
(5) the name, symbol, or code of the material(s) from which the
container is made, (6) a serial number or other identifying code that
will distinguish each individual container from all other containers,
and (7) the phrase ``Meets EPA standards for refillable pesticide
containers.''
This type of information is typical of that required by DOT,
recommended by the United Nations, and recommended by the Midwest
Agricultural Chemicals Association (MACA), a regional trade
association, to be marked on refillable containers for chemicals and
substances. MACA's Bulk Pesticide Task Force Committee has developed
specifications, called the MACA-75 standards, in consultation with
technical, regulatory, and legal experts. The MACA-75 standards are
voluntary manufacturer specifications and user guidelines for
refillable containers for liquid pesticides and other agri-chemicals
not subject to DOT specification packaging (Ref. 38).
The following table summarizes the markings representing each of
the packaging standard schemes. DOT standards listed are those for the
Specification 57 containers (metal portable tanks). The U.N.
Recommendations specify certain markings for all intermediate bulk
containers (IBCs) and additional markings for each individual type of
IBC; e.g., metallic, rigid plastic, flexible, etc. (Ref. 76). The table
includes the information that would be on a metallic IBC, including the
markings common to all IBCs. The table also lists the information
specified by the MACA-75 standards and proposed by the part 165
standards.
Permanent Marking Required by Representative Packaging Standards
------------------------------------------------------------------------
U.N. metal
Type of marking DOT 57 IBC MACA 75 Part 165
------------------------------------------------------------------------
Container
manufacturer....... X X X X
Volumetric capacity. X X\1\ X X\2\
Rated gross weight.. X X X X\2\
Materials of
construction....... X X\1\ X X
Serial number....... X X\1\ X X
Date of manufacture. X X X
Specification
identification..... X X
Code identifying IBC
type............... X
Code identifying
packaging group.... X
Model number........ X
Design pressure..... X X\1\ X
Tare weight......... X X\1\ X
Original (or
leakage) test date. X
Date of last
leakproofness test. X\1\
State authorizing
mark............... X
Stacking test load.. X
U.N. packaging
symbol............. X
Minimum thickness... X\1\
Date of last
inspection......... X\1\
Test pressure....... X
``Meets EPA
standards''........ X
------------------------------------------------------------------------
\1\ These are standards for metallic IBCs only. The other markings
identified in this column are for all IBCs.
\2\ The proposed part 165 standards would require either the volumetric
capacity or the rated gross rate.
The information EPA is proposing to be marked on refillable
pesticide containers is a subset of the three examples. Different
pieces of information are intended to be used for different purposes.
The name of the container manufacturer and model number are
necessary for registrants, refillers, and EPA and State inspectors to
be able to identify acceptable containers. Under this proposed rule,
registrants would be responsible for refillable containers meeting the
container design standards. A registrant would also be required to
develop and provide to refillers a list of containers that are
acceptable for refilling with the registrant's product(s). Marking the
container with the container manufacturer and the container model
number would provide registrants with a way to identify the acceptable
containers to refillers.
Each model number should identify one and only one design type.
This would facilitate EPA's ability to trace a particular minibulk
container (with a model number) to a design type and then to the
relevant drop test data. EPA is considering adding a regulatory
requirement that would prohibit a model number from identifying more
than one design type. EPA requests comments on the necessity and
feasibility of this potential requirement.
Additionally, identifying the container manufacturer, the model
number, the date of manufacture, and the serial number would help
registrants or refillers to determine the source of a faulty container
or batch of containers.
The container's date of manufacture and material(s) of construction
are intended to facilitate safe disposal of the containers. The date of
manufacture is necessary on plastic liquid minibulk containers so a
refiller could determine if a container's maximum lifetime of 6 years
after the date of manufacture (as described in Sec. 165.134(f)) has
expired. While other types of refillable containers do not have a
maximum lifetime specified in the regulations, the date of manufacture
would still be useful to manage a container throughout its life.
The phrase ``Meets EPA standards for refillable pesticide
containers'' is intended to provide a quick way for registrants,
refillers, and inspectors to identify a container as one that meets the
standards of subpart G. Although further inspection would be necessary
to determine if the container is acceptable for a particular product,
the phrase could serve as a useful initial check. Also, this phrase
would provide an easy means for EPA inspectors to identify pesticide
containers.
Proposed Sec. 165.124(b)(2) would state that if any of the
information, such as the date of manufacture, the rated capacity, the
material of construction, or the serial number, is required by DOT
regulations or by the terms of a DOT exemption, then compliance with
DOT's requirement would satisfy the corresponding requirement of this
paragraph. DOT exemptions are product-specific and include a series of
container specifications and requirements. ``By the terms of a DOT
exemption'' means according to the standards contained in an exemption
approved by DOT under the provisions of 49 CFR part 107. Section
165.124(b)(2) is included to prevent duplicative requirements between
the proposed part 165 regulations and the DOT regulations.
4. Minibulk containers. Section 165.124(c) would establish a
general integrity standard for minibulk containers under conditions of
normal storage, distribution, sale, and use. With one exception, this
standard is the same as the nonrefillable container integrity standard
proposed in Sec. 165.102(b) and discussed in Unit IV.B.3 of this
preamble. The difference between the two standards is that
compatibility between the minibulk container and the pesticide product
sold or distributed in the container is not included in the integrity
standard for minibulks because it is addressed by the registrant's
written list of acceptable containers.
One goal of the container design standards is to ensure that
refillable containers have a minimum degree of durability and strength.
To facilitate this goal, Sec. 165.124(d) would require a drop test for
minibulk containers (for both dry and liquid formulations). The drop
test standard proposed in this rulemaking is intended to serve as a
benchmark indicator of the strength and durability of containers. The
standard does not serve as a guarantee that a minibulk container will
be able to withstand the ``wear and tear'' associated with repeated
refilling and reuse.
Liquid minibulk and dry minibulk containers generally are portable
containers that are transported from refillers to the field and back.
EPA has data on a number of spills that have occurred when minibulk
containers were damaged when they fell out of vehicles during
transportation. For example, the Illinois Environmental Protection
Agency investigated at least four incidents of this type in 1989 (Ref.
55).
Also, 11 incidents involving spills from minibulk containers during
transportation were reported between 1985 and 1989 to the National
Response Center (NRC) (Ref. 60). The NRC, administered by the U.S.
Coast Guard, provides a Federal mechanism to receive and refer for
action and/or investigation reports of oil, chemical, biological, and
etiological releases into the environment in the United States and its
territories. Some incidents involving releases of certain hazardous
substances or materials listed under several statutes, including the
Comprehensive Environmental Response, Compensation, and Liability Act,
secs. 101(14) and 102 (42 U.S.C. 9602) and the Transportation Safety
Act of 1974 (49 U.S.C. 1802 and 1803), are required to be reported to
the NRC. These statutes, however, include only some pesticides on their
list of hazardous substances or materials. Thus, only a portion of the
incidents involving pesticides must be reported to the NRC, and the
actual number of spills is probably larger.
The above data show that minibulk containers can and do fall off
transportation vehicles. Minibulks also can be dropped while being
loaded into or out of vehicles or while being handled with forklifts.
Therefore, EPA believes that minibulk containers should be designed to
minimize the potential for container damage that could result in a
pesticide release.
Portable containers must be durable enough to withstand potential
stresses and strains that may be encountered during repeated
transportation, rinsing, and refilling. While this handling is
difficult to simulate, certain performance tests and criteria can be
established to ensure that the containers are sturdy enough to
withstand some potential abuse, such as sudden impacts, jars, or drops.
Most packaging standards, such as the DOT Hazardous Materials
Regulations (HMR) and U.N. Recommendations, specify a series of tests,
which may include bottom lift, top lift, stacking, leakproofness,
hydraulic pressure, drop, and vibration tests.
EPA considered a number of different tests as indicators of
minibulk container durability and integrity, including leakproofness,
pressure, drop, vibration, stacking, and lift tests. In this proposed
rule, EPA has chosen to focus on the drop test. EPA's intent is to set
a minimum number of standards to address the problems specific to
pesticide containers and to have these standards apply to all pesticide
minibulk containers, regardless of the hazard classification of the
pesticide in the container. The drop test was selected because the data
available to EPA indicate that the drop test best simulates the type of
incidents that commonly result in pesticide releases from minibulk
containers. As EPA gains experience and knowledge of the problems with
pesticide containers, EPA may reconsider the necessity of some of the
other tests.
EPA would like to be consistent with existing packaging
requirements, which would minimize the potential for duplicative
testing. EPA considered adopting a drop test standard from three
different organizations -- U.N., DOT, and MACA. EPA has chosen to
incorporate U.N. drop tests into the proposed regulations because U.N.
tests are the most universally accepted and used of the three drop
tests discussed in this preamble. Additionally, DOT has published a
proposed rule that would incorporate U.N. standards for IBCs into the
HMR (Ref. 84). Therefore, proposing the U.N. standard is consistent
with EPA's goal of minimizing the potential for duplicative testing.
In the DOT regulations, the drop tests are designated for each
individual type of container. For example, the Specification 57 metal
portable tank must be capable of passing a 2-foot drop test (49 CFR
178.253-5). A Specification 34 container, a reusable polyethylene drum
for use without overpack, must be capable of passing two different 4-
foot drop tests, where one is at a low temperature (49 CFR 178.19-7).
In December 1990, DOT published HM-181, a significant revision of
the previously existing HMR. One of the goals of HM-181 is to align the
HMR with U.N. Recommendations (Ref. 82). The performance standards in
HM-181 apply to non-bulk packagings with liquid capacities of 450
liters (119 gallons) or less or, for solids, capacities of 400
kilograms (882 pounds) or internal volumes of 450 liters or less. These
requirements could apply to minibulk containers that are smaller than
400 kilograms or 450 liters.
HM-181 will not change the testing requirements for minibulk
containers with capacities of greater than 450 liters or 400 kilograms.
In other words, HM-181 does not incorporate U.N. standards for IBCs. As
mentioned above, however, DOT recently published a NPRM that would
incorporate the standards for IBCs in Chapter 16 of U.N.
Recommendations into the HMR (Ref. 84).
EPA estimates that about one-third of all pesticide active
ingredients are classified as DOT hazardous materials. Specification 57
metal portable tanks often are used for pesticides that are DOT
hazardous materials. However, any plastic minibulk that currently is
being used for a pesticide classified as a DOT hazardous material must
receive an exemption from DOT, because there are no specifications
established by regulation for plastic portable tanks. For plastic
portable tanks, the specifications and requirements set out in the
exemptions are generally based on the requirements in Specification 34.
EPA chose not to incorporate any of DOT's drop tests, because the
tests were too specific to certain containers. EPA's goal is to set one
drop test standard for all minibulks for all pesticides. Incorporating
the DOT drop tests and ensuring consistency would require making the
same quantity, material of construction, and hazard class distinctions
that are in the HMR. EPA believes this would be too complicated and
inconsistent with the goal of establishing minimum standards applicable
to all pesticide containers. In addition, many of the detailed
specifications are being phased out over the next several years,
according to the schedule set out in HM-181.
EPA also considered the drop test recommended in the MACA-75
standards. The MACA-75 standards detail a 2-foot drop test and specify
that nonmetallic tanks be tested at a low temperature. While this drop
test has the benefit of being developed by a segment of the
agricultural industry and having industry support, EPA has decided not
to propose the MACA-75 drop test because it would not be consistent
with either the DOT regulations or U.N. standards. Also, while the
MACA-75 standards are well known and commonly used in the agricultural
pesticide market, they are virtually unknown in other markets, such as
the institutional and industrial segments, and the part 165
requirements would apply to containers for pesticides used in all of
these markets.
U.N. Recommendations specify drop tests for each type of IBC
[containers with capacities greater than 450 liters (119 gallons) but
less than or equal to 3,000 liters (793 gallons)], including metallic,
flexible, rigid plastics, composite with plastic inner receptacles,
fiberboard, and wooden containers. Many minibulk containers would be
classified as IBCs.
Many dry minibulk containers are refillable bags and therefore have
flexible bodies, although EPA is aware of at least one dry minibulk
design type with a rigid plastic body. Liquid minibulk containers have
metal or rigid plastic bodies. Therefore, EPA has incorporated U.N.
drop tests for IBCs with flexible, metal, and rigid plastic bodies into
the proposed rule.
Section 165.124(d)(1) would require each liquid and dry minibulk
container design type to pass successfully the appropriate drop test.
In addition, Sec. 165.124(d)(2) would require that each minibulk
container be capable of passing the appropriate drop test, even though
each minibulk container would not have to be tested.
Section 165.124(d)(3) would require the drop tests to be conducted
in accordance with the Good Laboratory Practice Standards in 40 CFR
part 160.
Proposed Sec. 165.124(d)(4) would state that if a pesticide product
is required to be packaged according to DOT standards and the DOT
requirements include a drop test, then compliance with the DOT drop
test would satisfy the part 165 minibulk drop test requirement.
However, the registrant still would have to comply with the
certification and recordkeeping requirements concerning the drop test
in Sec. Sec. 165.126 and 165.128.
The registrant would not necessarily have to conduct the drop test;
the container manufacturer or another entity could actually conduct the
testing. However, the registrant would be responsible for ensuring that
the container meets the drop test standard. The actual methodology for
the drop tests is proposed in Sec. 165.125 and discussed in Unit V.B.7
of this preamble.
5. Apertures. Section 165.124(e) would address the potential
problem of contamination in liquid minibulk containers by requiring
each aperture of a liquid minibulk to have a one-way valve and/or a
tamper-evident device. EPA's concern about contamination of pesticide
product in liquid minibulks arises partly because refillers and
registrants have little or no control over what happens to these
containers when they are in the field. EPA has received anecdotal
evidence of end users removing pumps from minibulks in efforts to
remove all of the pesticide from the containers (Ref. 74). This
situation is problematic for the refiller, because the refiller has no
assurance about whether the end user simply tried to remove all of the
product or used the container to store a substance other than the
pesticide product.
EPA believes that tamper-evident devices are needed on all liquid
minibulk container openings unless access into the container is
prevented by other design features, such as one-way valves. One-way
valves and tamper-evident devices (both terms are defined in proposed
Sec. 165.3) would not prevent pumps and closures from being removed
from containers. However, EPA believes that one-way valves and tamper-
evident devices would give refillers reasonable indication about
whether substances other than the pesticide product for which the
containers are labeled may have been introduced into the containers.
These design requirements would be an important part of ensuring the
safe refilling and reuse of liquid minibulk containers.
Many liquid minibulk containers have several openings, or
apertures, including a vent, an opening used for filling and/or
cleaning the container, and an opening used for withdrawing products.
However, some of the smaller liquid minibulk containers (small volume
returnables) have a single opening that serves as a filling and
withdrawal port and may also provide a venting mechanism.
Many liquid minibulk containers that are currently being produced,
particularly those that meet MACA-75 standards, already have tamper-
evident devices. Many of the liquid minibulk containers that are
currently used have one-way valves on the withdrawal port, because
container manufacturers and registrants are concerned with preventing
users from introducing foreign materials into the opening from which
pesticide is dispensed. EPA believes that all minibulks should have
these minimal protective measures.
The most common type of tamper-evident device currently used in the
agricultural pesticide industry is a wire that is attached to the
closure and then hooked through a slot, like the eye of a needle. The
refiller seals the wire to form a loop after the container is refilled.
The wire loop is broken if anyone attempts to remove the closure from
the container. Other types of tamper-evident devices include cables,
heavy tape, or plastic rings that are broken or removed if the closure
is removed from the container.
One issue regarding one-way valves is the location of the valve.
Specifically, would the valve have to be part of the container, or
could the one-way valve be part of the equipment attached to the
container to withdraw pesticide? This is an important consideration for
small volume returnable containers, because there is often only one
opening on the container. If a one-way valve allowing pesticide
withdrawal were placed in the container, this valve would have to be
braced open to fill the container, which is difficult to accomplish.
Instead, many small volume returnables are designed with the one-way
valve in the coupler that must be used to withdraw product from the
container.
EPA's intent with the requirement for one-way valves is to prevent
any person other than the refiller from placing material into the
container. Therefore, it would be acceptable to have the one-way valve
in a coupler that attached to the container if the coupler is the only
reasonably foreseeable way to withdraw pesticide from the container.
EPA requests comment on the issue of locating the one-way valve.
Another question regarding tamper-evident devices and one-way
valves is whether these requirements should apply to dry refillable
containers as well. EPA encourages the incorporation of tamper-evident
devices and one-way valves into the design of dry minibulk containers.
However, EPA does not believe it is appropriate to require them at this
time. EPA has no information indicating that there is a problem with
contamination caused by dry minibulk containers being used to store or
transport substances other than pesticide and then being returned for
refilling. EPA requests comments on whether a requirement for tamper-
evident devices and one-way valves should apply to dry minibulk
containers.
6. Bulk containers. Section 165.124(f) proposes standards for
liquid and dry bulk containers at refilling establishments of refillers
operating under contract to or written authorization from a registrant.
EPA is interested in the integrity, strength, and durability of bulk
containers, which are generally used for stationary storage of large
quantities of pesticides. Bulk containers are often located outside and
therefore may be subjected to rough weather conditions, including
direct sunlight, precipitation, and temperature extremes. Because bulk
containers are larger than minibulk containers, the potential for a
large release exists if container integrity is breached.
Because of the possible costs and inherent dangers associated with
large volumes of pesticides, bulk containers usually are designed and
constructed to be strong and durable. However, some refillers have
experienced problems with leakage from the fittings on liquid bulk
containers, particularly when corrosive pesticides are being stored.
As stated earlier, subpart G does not apply to the design of
transport vehicles. In this proposal, EPA intends to regulate the
design of large, stationary containers that are used for the
distribution or sale of pesticide. Specifically, the opening paragraph
in Sec. 165.124(f) would specify that the standards in Sec. 165.124(f)
would apply only to bulk containers at the refilling establishments of
refillers operating under contract to or written authorization from a
registrant.
The standards for bulk containers in Sec. 165.124(f) would not
apply to bulk containers at a registrant's facility. A bulk container
at a registrant's facility could be used for many purposes, including
storing raw materials (active ingredients or inerts), formulating a
product, storing a product before it is packaged into nonrefillable
containers, and storing a product that will be transferred into tank
trucks. Without limiting the applicability of Sec. 165.124(f), the
proposed container design standards for bulk containers would apply to
registrants' bulk containers used for storing a pesticide product that
will be transferred into tank trucks or directly into portable
refillable containers. EPA does not have enough information at this
time on whether there are bulk container problems at registrant
facilities. EPA believes that many of the registrants' bulk containers
are located indoors, and therefore are not subjected to the
deteriorating effects of the weather. As discussed in Unit IV.B.1 of
this preamble regarding manufacturing use products, it is possible that
the stewardship of containers at registrant facilities is better than
that at other levels of the pesticide distribution chain, because
containers at registrant facilities are handled by workers who are used
to and trained to handle chemicals on a regular basis. Additionally,
EPA believes that economic considerations would push registrants to
having containers of sufficient integrity to hold the product.
However, EPA is considering applying the standards of
Sec. 165.124(f) to registrants' bulk containers that are used to sell
or distribute a pesticide product, because there is an inherent risk
associated with bulk containers due to the quantity of product they
hold. EPA requests comment on whether it is appropriate to apply the
standards in Sec. 165.124(f) to those bulk containers at registrants'
facilities that are used to sell or distribute pesticide products in
refillable containers.
Also, the standards of Sec. 165.124(f) would not apply to bulk
containers at custom blenders or independent custom applicators if
these facilities are not refilling establishments where a refiller is
operating under contract to or under written authorization from a
registrant. However, proposed subpart H would require bulk containers
at independent custom applicators and custom blenders to be secondarily
contained. EPA believes that the number of bulk containers at custom
blenders and custom applicators that would be subject to subpart H but
not subpart G is limited -approximately 340 containers. However, since
EPA has no reason to believe that the bulk containers at refilling
establishments are different from those at the facilities of
independent custom applicators or custom blenders, EPA is considering
expanding the scope of subpart G to apply the standards in
Sec. 165.124(f) to all bulk containers used to store or to sell or
distribute a pesticide product at independent custom applicators and
custom blenders in the final rule. EPA requests comments on any reasons
why the standards should not be expanded.
Many current State regulations for bulk pesticide storage address
the integrity of the containers used to store pesticide (Ref. 70).
Generally, these State specifications are performance standards that
address the stresses and conditions that a container most likely would
have to withstand. EPA is proposing to regulate the integrity of bulk
containers in a manner similar to that of many States. In fact, the
language that EPA is proposing for the container integrity of dry and
liquid bulk containers in Sec. 165.124(f)(1) is based, in part, on bulk
pesticide storage regulations in Wisconsin and Minnesota (Refs. 40 and
79).
Proposed Sec. 165.124(f)(1)(i) would specify that bulk containers
would have to meet the integrity standards except during a civil
emergency or an act of God. By act of God, EPA means any unanticipated
grave natural disaster or other natural phenomenon of an exceptional,
inevitable, and irresistible character, the effects of which could not
have been prevented or avoided by the exercise of due care or
foresight. This proposal incorporates the definition of act of God from
section 101(1) of the Comprehensive Environmental Response,
Compensation, and Liability Act [92 U.S.C. 9601(1)].
Proposed Sec. 165.124(f)(1)(ii) would require all bulk containers
and their appurtenances to be resistant to extreme changes in
temperature. Also, all bulk containers and their appurtenances would
have to be constructed of materials that are adequately thick to not
fail and that are resistant to corrosion, puncture, and cracking. Under
Sec. 165.124(f)(1)(iii), the containers would have to be capable of
withstanding all operating stresses, taking into account static head,
pressure buildup from pumps and compressors, and any other mechanical
stress to which the containers may be subjected in the foreseeable
course of operations.
In addition to the containers' integrity, EPA is concerned about
the potential development of high internal pressures in liquid bulk
containers. Because the bulk containers are often located outside, they
may be subjected to direct sunlight and high temperatures.
Many States with bulk pesticide storage regulations require the
storage containers to be equipped with vents. In Sec. 165.124(f)(2),
EPA is proposing that each liquid bulk container be equipped with a
vent or other device designed to relieve excess pressure, prevent
losses by evaporation, and exclude precipitation. This proposed
requirement is similar to that in Minnesota's bulk pesticide storage
regulations (Ref. 40).
One kind of vent that would meet this requirement is a conservation
vent. Such a vent is normally closed, but will open under either vacuum
or internal pressure. Wisconsin's bulk pesticide storage regulations
require each fixed storage container used for liquid bulk pesticide to
be equipped with a conservation vent (Ref. 79).
EPA also is proposing to prohibit external sight gauges on liquid
bulk containers. As described in Sec. 165.124(f)(3), external sight
gauges are pesticide-containing hoses or tubes that run vertically
along the exterior of the container from top to bottom. External sight
gauges are vulnerable to damage and could cause all of the contents of
a container to be released if they are broken. Therefore, EPA believes
it is necessary to prohibit external sight gauges to ensure the safe
use, reuse, and refilling of liquid bulk containers. There are other
ways to determine the volume of liquid pesticide in a container,
including float gauges, calibrations on the side of translucent plastic
containers, calibrated dip sticks, and electronic devices (Ref. 79).
In Sec. 165.124(f)(4), EPA proposes to require all connections on
liquid bulk containers, except for vents, to be equipped with shutoff
valves that can be locked closed. A shutoff valve is a valve that
allows the flow of pesticide from the container connection to be
stopped. EPA believes it is necessary to have shutoff valves to
decrease the potential for a large spill. For example, if a hose broke
during the transfer of pesticide from a container in the absence of a
shutoff valve, pesticide would continue to be released from the
container until the container was empty or until the hose could be
replaced, which could be a very risky mechanical intervention. However,
if the connection had a shutoff valve, a person could stop the flow of
pesticide simply by closing the valve. EPA is proposing that the
shutoff valve has to be able to be locked to prevent releases due to
vandalism. Many currently available valves can be locked closed with a
simple padlock.
EPA is not currently proposing to regulate the location of the
shutoff valve. The Wisconsin pesticide bulk storage regulations,
however, specify that the shutoff valve be ``located on the storage
container or at a distance from the storage container dictated by
standard engineering practice'' (Ref. 79). In a guidance document
explaining the regulations, Wisconsin clarifies that ``the valve should
be no farther from the container than 3 times the diameter of the
plumbing being used to connect the valve to the container. For cone
bottom tanks the first valve can be located within three pipe diameters
of the tank skirt or frame, provided the pipe is rigidly connected to
the skirt or frame'' (Ref. 79). EPA believes it may be necessary to
specify the location of the shutoff valve to ensure that it is located
within the secondary containment structure, if containment is required.
EPA requests comments on whether it is necessary to regulate the
location of shutoff valves, and if so, what the location should be.
7. Minibulk container drop test methodology. Proposed Sec. 165.125
would prescribe the drop test methodology for flexible, metal, and
rigid plastic minibulk containers. Wherever possible, EPA has used the
exact wording in U.N. Recommendations. Significant changes and
additions are discussed below.
Section 165.125(b) describes the preparation and general
requirements that would be necessary for all of the specific drop
tests. A difference between the proposed tests and U.N. tests is the
requirement in Sec. 165.125(b)(2) that any pump, valve, meter, hose, or
other hardware that is attached to the container during transportation,
storage, or use would also be attached during the test. EPA is
proposing this requirement because, as discussed previously, minibulk
containers usually are transported from the dealer to the field with
the associated hardware attached to the containers. Unless minibulk
containers are designed to provide protection, the appurtenances can be
damaged or sheared off of the containers in the case of sharp blows or
jolts to the containers. As a result, the pesticide could spill from
the ruptured container.
Preventing a spill when a container is dropped with hardware
attached can be achieved in several ways. The pump can be recessed;
e.g., the liquid minibulk can be designed with a depression or area in
which the pump fits without protruding from the contour of the
container. Another type of protection is a 10- to 12-inch lip or ridge
on the top of the container that extends above the level of the pump.
An alternative design with the same purpose is a spring-loaded check
valve in the connection between the pump and the minibulk. If the pump
is sheared off or jolted out of place, the spring automatically closes
the valve and leakage is prevented. Both of these options -- hardware
protection and the use of a spring-loaded check valve -- offer equal
environmental protection, although the extent to which pumps are
damaged may vary considerably.
Sections 165.125(b)(4) through (b)(6) would set out the conditions
under which a container could be drop tested with a test material other
than the pesticide product that will be transported in the container.
The registrant would be responsible for selecting an appropriate test
substance. Section 165.125(b)(4) would allow a substance to be
substituted for a dry pesticide if it has the same physical
characteristics, such as mass and grain size, as the pesticide to be
carried. Section 165.125(b)(4) also would allow the use of additives
such as lead shot to achieve the requisite total package mass, as long
as they are placed so that the test results are not otherwise affected.
Section 165.125(b)(5) would allow a container for a liquid pesticide to
be tested with another substance, if the other substance's relative
density and viscosity are similar to those of the pesticide to be
carried. Section 9.5 of the U.N. Recommendations states that relative
density and specific gravity are considered to be synonymous (Ref. 76).
Section 165.125(b)(6) would set out the conditions where water could be
used as the test substance.
EPA is not proposing numerical standards to define ``similar
relative density and viscosity.'' Instead, EPA is placing the
responsibility for determining the similar relative density and
viscosity of a test substance on the registrant. EPA anticipates that
most registrants will test their containers using water as the test
substance, in accordance with Sec. 165.125(b)(6), and therefore won't
have to determine whether a test substance has similar relative density
and viscosity. EPA requests comments on whether ``similar'' relative
density and viscosity should be defined.
Sections 165.125(b)(4) through (b)(6) propose requirements based on
the relative density or another characteristic of the pesticide to be
sold or distributed in the container. In other words, the testing would
be specific to a single formulation and container combination, which
could be problematic if the minibulk container is not going to be
dedicated to a specific product. However, the tests in
Sec. Sec. 165.125(c) through (e) are written to allow a test done at a
drop height higher than the required minimum to satisfy the drop test
conducted at the minimum height. Therefore, a registrant could drop
test a minibulk container based on the most dense pesticide product to
be sold or distributed in the minibulk container and satisfy the drop
test requirement for any of its products to be sold or distributed in
the container.
For example, a test for a pesticide with a relative density of 1.4
that is conducted with water as the test substance would require a drop
height of 1.4 meters, according to proposed Sec. 165.125(b)(6)(ii).
(Drop height = 1.4/1.2 x 1.2 meters = 1.4 meters). A container that
passed this 1.4-meter test could also be used to package a pesticide
product with a relative density of 1.3, because the testing height of
1.4 meters would be greater than the required height (1.3 meters).
Therefore, if a registrant intends to use a container to sell or
distribute several products, the container would only have to be tested
(with water) at a drop height based on the pesticide product with the
largest relative gravity.
Section 165.125(b)(7) would require the test records to include the
number of containers of each particular design type that were tested
for the design type to successfully pass the drop test. This would
indicate whether a registrant simply continued to test a container
design type until one container passed. EPA believes that there are
market incentives to prevent registrants from continuing to test
containers of a design type that fails more than once or twice,
including the cost of the minibulk containers and, more importantly,
the liability and associated problems of containers failing in the
field. However, EPA is considering establishing a regulatory limit on
how many times a design type could be tested. For example, EPA could
set a standard such that if two containers of a design type fail the
drop test, the entire design type would fail and would have to be
modified. This would ensure that a maximum of two containers would be
tested unsuccessfully for a given design type. EPA requests comments on
whether it is necessary to limit the number of containers of each
design type that can be tested before one container passes and, if so,
whether the approach discussed above is appropriate.
Sections 165.125(c) through (e) would provide specific details for
the drop tests. These specifications would mandate the capacity to
which the container is to be filled, the type of surface to receive the
drop, the drop height, and the criterion for passing the test. Section
165.125(c) would apply to dry minibulk containers with flexible bodies,
but not to liquid minibulk containers, because EPA is assuming that
liquid pesticides would not be transported in refillable containers
with flexible bodies. EPA requests information on any liquid pesticide
products that are distributed or sold in flexible refillable
containers. As proposed in Sec. 165.125(c)(1), EPA considers a minibulk
container with a flexible body to consist of a body constituted of
film, woven fabric, or any other flexible material or combination
thereof. This description of flexible bodies is based on the U.N.
definition of flexible IBCs in section 16.3.2.1 of the U.N.
Recommendations (Ref. 76).
Section 165.125(d) would apply to minibulk containers (for either
liquid or dry product) with metal bodies. Different filling
requirements and drop heights would be used for testing containers for
liquid or dry formulations. Similarly, Sec. 165.125(e) would apply to
minibulks (for either liquid or dry product) with rigid plastic bodies,
with different filling requirements and drop heights for liquid or dry
minibulk containers. The different filling requirements in
Sec. Sec. 165.125(d) and (e) -- to 95 percent of the capacity for dry
minibulks and to 98 percent of the capacity for liquid minibulks -- are
the same as specified in U.N. Recommendations.
Proposed Sec. Sec. 165.125(d)(4) and (e)(5) would require the
container to be dropped ``on that part of the base considered to be the
most vulnerable.'' EPA anticipates that this would require the
containers to be dropped onto a corner or edge of the base rather than
flat on the base of the container to fulfill this requirement.
The drop heights in U.N. specifications vary according to the
hazard level (packing group number) of the substance to be transported
in the container (Ref. 76). The drop height is 1.2 meters (3.9 feet)
for packing group II substances and 0.8 meters (2.6 feet) for packing
group III. EPA is proposing different drop heights, depending on
whether the pesticide formulations to be sold or distributed in the
containers are dry or liquid. For liquid minibulks, EPA is proposing
the packing group II test -- a drop of 1.2 meters. For dry minibulk
containers, EPA is proposing the packing group III test, which is less
stringent - a drop of 0.8 meters.
EPA is proposing a higher drop height for liquid minibulks to
ensure environmental protection. EPA believes that a higher drop height
for liquid minibulk containers is appropriate because it is more
difficult to contain and recover a release of liquid material than a
release of dry material.
In some ways, U.N. drop tests are not as rigorous as some of the
DOT and MACA drop tests. The orientation in which the container is
dropped in the drop tests in the DOT Specification 57 and MACA-75
standards is more demanding than the orientation in U.N. IBC drop
tests. For example, Specification 57 requires a ``free drop onto a flat
unyielding horizontal surface, striking the target surface in the
position and attitude from which maximum damage to the tank (including
piping and fittings) is expected'' [49 CFR 178.253-5(a)(2)]. In order
to comply with this requirement, the container generally would be
dropped on its top -- either on the fittings or a corner -- which would
cause the force of the container contents to impact directly on the
closures. The closures are often on the top of the container and are
one of the container parts most likely to fail. On the other hand, the
drop test for IBCs with metal or rigid plastic bodies in U.N. standards
(section 16.2.8.6.3) specifies a drop ``in such a manner as to ensure
that the point of impact is on that part of the base of the IBC
considered to be the most vulnerable'' (Ref. 76). In this orientation,
the initial force of the container contents would impact upon the
bottom of the container. The base of the container is generally less
likely to fail than a closure, given similar conditions (wall
thickness, container material, etc.)
Considering the difference in severity between the orientation of
the U.N. IBC drop test (also the proposed part 165 test) and the DOT
Specification 57 drop test, EPA believes it is appropriate to propose a
drop height of 1.2 meters (3.9 feet) for liquid minibulk containers
instead of 2 feet, like the DOT Specification 57.
EPA requests comments on whether the drop tests being proposed are
appropriate.
8. Container design responsibility. A significant issue regarding
these proposed regulations is who should be held responsible for
ensuring that the refillable containers would meet the standards in
Sec. 165.124. This proposal includes three different regulatory options
for who would be held responsible for doing so. The parties that
potentially could be held responsible include registrants, refillers,
container owners, and container manufacturers. However, before these
options are presented, it is necessary to provide background
information on the pesticide registration regulations in 40 CFR part
152, the usual distribution chain for products that are repackaged into
refillable containers, and the way in which refillable containers enter
the distribution chain.
A registrant must submit, among other things, formulation
information, data, and labeling to EPA to obtain a registration for a
pesticide product. A ``pesticide product,'' as defined at 40 CFR
152.3(t), includes the composition, packaging, and labeling of the
pesticide in the form in which the pesticide is, or is intended to be,
distributed and sold. In the typical nonrefillable chain of commerce,
the registrant produces the pesticide formulation, packages it or
contracts for the packaging, labels it, and releases it for
distribution or sale. The package is not opened until it reaches the
end user. If a second producer wishes to repackage that pesticide, that
producer must obtain a separate registration for the product that
includes the formulation and the second registrant's package and label.
In the refillable chain of commerce, pesticide products distributed
or sold in refillable containers and the containers themselves often
enter the pesticide distribution chain separately.
As discussed in Unit V.B.1 of this preamble, there are at least two
ways for product sold in refillable containers to enter the pesticide
distribution chain. First, some registrants package the products
initially into the refillable containers for distribution or sale. In
this case, the refillable containers and the products enter the
pesticide distribution chain together, much as a pesticide product in a
nonrefillable container would.
Second, and more commonly, pesticide products that are distributed
or sold in refillable containers are sold or distributed in ``bulk
form'' (large undivided quantities) by a registrant to a dealer who has
obtained written authorization to repackage the registrant's product
and to use the registered product's label. Such dealers are refillers
as defined in this proposal. The pesticide product is transferred from
tank cars or trucks to bulk containers at the dealer's facility. The
dealer then transfers the pesticide formulation from the bulk
containers into minibulk containers, generally for sale to end users.
In these situations, the containers and products may enter the
distribution chain at different times. Containers can be purchased from
container manufacturers by any party in the pesticide distribution
chain, including registrants, distributors, dealers, and end users.
While EPA has not been able to determine accurately the number of
liquid minibulk containers that are owned by each group nationwide, a
survey of refillers (dealers) in Iowa during the 1990 Iowa less-than-
56-gallon pilot project reported the following data:
(1) Seventy-five percent to 85 percent of liquid minibulk
containers were dealer-controlled (owned by registrant, owned by
dealer, owned by registrant and leased by dealer, etc.).
(2) Fifteen percent to 25 percent of liquid minibulk containers
were owned by farmers (Ref. 17).
In general, the minibulk containers that are purchased by
registrants and then loaned, leased, or sold to refillers are of
significantly better quality than other minibulks, including those
owned by end users or purchased directly by dealers.
Most liquid bulk containers are owned by refillers. Refillers may
purchase liquid bulk containers independently. Alternatively, a
registrant might give a refiller a liquid bulk container as part of an
incentive program to buy and sell the registrant's products in bulk.
For example, some pesticide manufacturers provide bulk storage tanks to
dealers, who then ``earn'' the cost of the container by meeting a
certain obligation for the volume of pesticide sold. Refillers also may
lease liquid bulk containers from pesticide registrants.
Dry minibulk and dry bulk containers generally are purchased and
owned by registrants, because currently, refillers repackage
predominantly liquid pesticide products. However, the number of
refillers that handle dry pesticide in large quantities is increasing.
Therefore, the number of refillers who purchase dry minibulk and dry
bulk containers also may increase.
a. Introduction to the options considered by EPA. As previously
discussed, any person in the pesticide distribution chain may provide
the container for refilling. The question is ``Who should be
responsible for assuring that refillable containers meet the container
design standards of part 165?'' EPA is proposing that registrants be
held responsible for meeting the container design standards for
minibulk and bulk containers.
In making the choice, EPA considered the following three regulatory
options.
(1) Registrants would be responsible for containers meeting the
proposed design standards. Registrants would identify the acceptable
containers to refillers and EPA by specifying the container
manufacturer and model number. In a variation to this option,
registrants would identify the acceptable containers to refillers and
EPA by specifying design type parameters.
(2) Anyone could request EPA's approval to use a certification
seal. This could be container manufacturers, but it also could be
registrants, refillers, or even end users. The seal would indicate that
a person had certified to EPA that the container meets the part 165
standards. Registrants would address container/formulation
compatibility by identifying design type parameters to refillers and
EPA.
(3) Container manufacturers would be responsible for containers
meeting the proposed design standards. Registrants would address
container/formulation compatibility by identifying design type
parameters to refillers and EPA.
In evaluating the options for container design responsibility, EPA
considered the differences among the options in terms of seeking the
least burdensome approach that is also effective, practicable, and
easily enforceable. EPA believes that Option 1 is more effective, more
practicable, and significantly more easily enforceable than the other
two options.
EPA also considered whether the proposed regulations would
encourage refillable containers. For the following reasons, EPA
considers it desirable to encourage the use of refillable containers
with the proposed part 165 container regulations:
(1) FIFRA section 19(e)(1)(B)(iv) encourages the use of refillable
containers; it directs EPA to promulgate regulations on container
design to facilitate safe refill and reuse.
(2) Refillable containers are consistent with the concept of
pollution prevention and waste minimization.
(3) The demand from end users for refillable containers is strong
and growing.
EPA believes there may be a difference among the options in terms
of whether the regulations would encourage refillable containers. EPA
requests comments on whether each option would encourage refillable
containers, as well as the reasons why or why not.
On the other hand, EPA does not believe there would be a
significant difference among the containers that are designed and
produced under the various options. EPA anticipates that container
manufacturers will make containers that meet the standards in order to
fulfill a market demand, regardless of who is responsible under EPA's
regulations.
Similarly, there may not be a big difference among the options in
terms of the costs to design complying containers. The containers
likely would be designed similarly regardless of who was responsible.
Also, the recordkeeping requirements and the associated costs would be
similar for all of the options. However, the party responsible for
recordkeeping varies, which may alter the burden of the proposed
regulation.
EPA requests comments on the differences in the risks, benefits,
and costs among the options, and on ways in which these options could
be improved.
b. Option 1-- Registrants, model numbers. In option 1, which is
preferred by EPA, registrants would be responsible for the containers
meeting the proposed design standards. The containers would be marked
with the phrase ``Meets EPA standards for refillable pesticide
containers.'' The phrase would not imply any degree of review or
acceptance by EPA. In proposed Sec. 165.126, registrants would be
required to certify to EPA that the refillable containers that are
refilled with their products meet the design standards. Under
Sec. 165.128, registrants would be responsible for maintaining records
on the refillable containers used to distribute or sell their products.
Registrants would be required by Sec. 165.130(b)(2) to develop a
written list of acceptable containers for each product. This list would
identify those refillable containers that could be used for selling or
distributing the registrant's product. Acceptable containers would be
those that the registrant has determined meet the standards of
Sec. 165.124 and are compatible with the pesticide formulation to which
the list applies. As described in Sec. 165.130(b)(2)(ii), the
containers would be required to be identified by, at a minimum, the
container's manufacturer and model number. Section 165.130(c) would
require registrants to provide this written list of acceptable
containers to refillers. Under the proposed Sec. 165.132, registrants
would be required to keep a copy of the list of acceptable containers.
EPA would have access to this list because the registrant would be
required to make the records available for inspection and copying and
to submit them upon request.
Refillers would be required by Sec. 165.134(c)(1)(i) to refill
product only into refillable containers that are identified on the
registrant's list of acceptable containers. The refiller would know
that the registrant had ensured that the containers on the list met the
standards of Sec. 165.124 and were compatible with the formulation.
Option 1 is sensible for several reasons. Under FIFRA, registrants
are responsible for the containers as part of the registered pesticide
product. Registrants already submit data and other information as
required to show that their pesticide products do not cause
unreasonable adverse effects on the environment. Registrants are in the
best position in terms of technical knowledge to determine which
containers are most suitable for their products. Also, between
registrants and nonregistrant refillers, registrants are generally
larger organizations and thus financially more capable of being
responsible for container testing.
Refillers would be able to identify allowable containers because
they could only repackage products into containers specified on the
lists of acceptable containers. It would be easy for refillers to
recognize the acceptable containers because the containers would be
identified by model numbers.
EPA inspectors easily would be able to determine whether a product
was refilled into a container meeting the requirements of part 165
because they would know (or have access to) the acceptable model
numbers. Similarly, EPA inspectors would be able to determine that
containers had been properly tested by inspection of registrants'
records.
Requiring registrants to be responsible for container design
standards may not encourage the use of refillable containers. The
regulatory approach of holding registrants responsible for container
design standards could have the effect of encouraging registrants to
dedicate containers to a specific pesticide product. With dedicated
containers, the number of minibulk and bulk containers needed by each
refiller could increase, which could place an increased storage,
handling, and maintenance burden on refillers. Another possible effect
could be to discourage farmer-owned containers, which may represent
about 15 percent to 25 percent of the current number of liquid minibulk
containers. EPA specifically requests comments on whether option 1
would encourage refillable containers.
The specific requirements of this option are discussed in greater
detail in Units V.B.9 through V.B.13 of this preamble.
As a variation to option 1, EPA considered requiring containers to
be identified by design type parameters rather than by the container's
manufacturer and model number. Under this variation, registrants would
still: (1) Be responsible for the containers meeting the proposed
design standards, (2) certify to EPA that the refillable containers
meet the design standards, and (3) maintain records for the refillable
containers. Refillers would be required to refill product only into
refillable containers that the registrant identifies as acceptable.
Similar to option 1, this variation has the potential to discourage
the use of generic refillable containers obtained independently by
refillers or users.
Another disadvantage of this variation is that refillers and EPA
inspectors may have difficulty identifying acceptable containers if
they are given only a description of the design type parameters instead
of a definitive list of acceptable models. EPA rejected this variation
partly because of this potential difficulty in identifying acceptable
containers.
In addition, EPA does not believe the container design parameters
could be described so that refillers would know what to look for in
determining acceptable containers. Therefore, EPA also rejected this
variation because it doesn't appear practicable or easily enforceable.
c. Option 2.-- Certification seal. Under option 2, any person would
be allowed to produce a container meeting EPA's design standards. In
addition, any person would be allowed to certify to EPA that the
container meets the part 165 standards. EPA would grant the person
permission to mark the container permanently with a seal (``the
certification seal''). The seal, which would indicate that a person had
certified to EPA that the container meets the part 165 standards, could
be a phrase such as ``Meets 40 CFR part 165 container standards.'' This
statement would be the only one that could be used as the seal. EPA
envisions that principally container manufacturers or registrants would
avail themselves of this option, but refillers or end users could also.
The submission to EPA would include a certification that the container
meets the part 165 container design standards, a description of the
container (including its design parameters, the container manufacturer,
and the container model number), and a citation to the location of the
test data and records. Use of the seal would be denied if the owner of
the data and records did not provide EPA access to inspect and copy the
data and records. The person who certifies compliance with the standard
would be required to maintain a copy of the certification submission.
EPA would grant permission to mark refillable containers
permanently with the seal if all of the certification submission
criteria were met. EPA would notify the person making the certification
of EPA's approval or disapproval to use the seal. EPA would not be
approving the refillable container, but rather, allowing the seal to be
used based on the certification. EPA could compile a list of the model
numbers for which approval to use the seal was granted.
This option could include persons other than registrants or
refillers. Section 19(e) of FIFRA does not restrict its applicability
to any particular persons, and there is no express statement of an
intent to limit applicability of FIFRA section 19(e) to registrants.
Refillers and registrants would be required to repackage product
only into containers that had the certification seal.
With this option, registrants would be required to address
compatibility between the containers and the pesticide formulations.
Compatibility depends to a great extent on the container's material(s)
of construction. Therefore, the registrant would be required to
develop, for each product, a list of container construction materials
that would be acceptable for the containers in which its product could
be distributed or sold. This would be similar to the list of acceptable
containers in option 1.
Registrants would be required to provide this written list of
acceptable container construction materials to refillers and to keep a
copy of it. Refillers would be required to repackage a pesticide
product only into refillable containers that are marked with the
certification seal and that are made from materials identified as
acceptable by the registrant.
Option 2 has several advantages. It allows more flexibility than
option 1, because refillers wouldn't be bound to specific container
models selected by the registrant, unless the registrant required its
pesticide to be sold or distributed in dedicated containers. This
flexibility might help encourage refillable containers because, in not
being limited to specific manufacturers and model numbers, it may be
easier for parties in the distribution chain to obtain acceptable
containers. It would be easy for refillers to identify allowable
containers, because they would look for the seal and also ensure the
container is made from a material the registrant has identified as
acceptable. Similarly, EPA inspectors could determine if a pesticide
had been repackaged into an improper refillable container by looking
for the seal and reviewing the registrant's list of acceptable
container materials. The inspectors would know or would have access to
a list of the model numbers of containers that have been certified to
meet the standard through the information supplied to EPA. EPA also
would have a list of the locations of the data and records. This
approach to data and recordkeeping would be similar to the inspection
of laboratories under the Good Laboratory Practice Standards in 40 CFR
part 160. As a condition for using the certification seal, permission
would have to be given for EPA to inspect testing facilities and the
data.
A disadvantage of this option is that the need to certify and to
obtain EPA permission to mark a container permanently with the
certification seal may discourage some persons from seeking approval of
a wide number of containers or from seeking improvements in existing
containers. Moreover, the disadvantage to EPA is the need to establish
and maintain what is, in essence, a licensing program for pesticide
containers with its accompanying costs and administrative requirements.
EPA believes an option that creates such administrative burdens for the
industry and EPA is a less desirable option.
Also, it could be more difficult to enforce this option because the
records and data could be held by container manufacturers, testing
facilities, registrants, refillers, or end users. EPA routinely
inspects registrants and registered establishments. EPA's enforcement
program, which is carried out in cooperation with the States, is
directed to registrants, producers, and users. In other words, EPA has
a framework for and experience in regulating registrants and producers,
but not for handling container manufacturers or other parties.
d. Option 3-- Container manufacturers. Under option 3, container
manufacturers would be responsible for containers meeting the design
standards in the proposed Sec. 165.124. The container manufacturer
would mark the containers permanently with a seal, which would be a
certification that the container meets the standards of part 165. As in
option 2, the seal could be a phrase such as ``Meets 40 CFR part 165
container standards.'' The container manufacturer would be responsible
for keeping records for the containers. Refillers would be required to
repackage product only into containers that were marked with the seal.
Similar to option 2, registrants would be required to address
compatibility between the containers and the pesticide formulations.
The registrant would be required to develop, for each product, a list
of construction materials that would be acceptable for the refillable
containers and provide this list to refillers. Registrants would keep
the requisite list of acceptable container materials, and would make
the list available to EPA and the states.
Refillers would be required to repackage pesticide product only
into refillable containers that are marked with the seal and that are
made from materials identified as acceptable by the registrant.
Option 3 makes sense for several reasons. It allows more
flexibility than Option 1, mainly because refillers wouldn't be bound
to specific container models selected by registrants, unless the
registrant required specific containers for its pesticide products.
This flexibility might help encourage the use of refillable containers
because it may be easier for parties in the pesticide distribution
chain to obtain acceptable refillable containers. Refillers could
identify allowable containers by looking for the seal and checking to
be sure that the container is made from a material the registrant has
identified as acceptable. Similarly, EPA inspectors could determine if
pesticide has been repackaged into an improper refillable container by
looking for the seal and reviewing the registrant's list of acceptable
container materials.
Because this option assigns responsibility for container design
standards to container manufacturers, it departs from the traditional
FIFRA regulatory scheme that places the burden of registrability of
pesticides on pesticide registrants. However, section 19(e) of FIFRA
does not restrict its applicability to any particular person. Neither
FIFRA section 19 nor the legislative history for the 1988 amendments to
FIFRA indicate Congress intended to preclude regulation of container
manufacturers for container design.
Under option 3, EPA would be entering an industry sector it has
never regulated before under FIFRA. The disadvantage and the main
reason this option was rejected is that EPA lacks information and
experience in this industry, and has no regulatory infrastructure in
place. Also, EPA's enforcement capability could be limited because
there is no link between responsibility for container design and sale
or distribution of the pesticide.
Again, EPA welcomes comments on the merits and drawbacks of these
options.
9. Certification, recordkeeping, and inspection. As discussed
regarding option 1, registrants would be required to certify that the
containers meet the container design standards and to maintain records
regarding these standards.
Proposed Sec. 165.126(a) would require registrants to certify, for
each product sold or distributed in refillable containers, that all
refillable containers in which that product is distributed or sold meet
the standards of Sec. 165.124. This would apply both to registrants who
distribute or sell pesticide product to refillers for refilling and to
registrants who distribute or sell pesticide product in refillable
containers. Section 165.124(b) would specify the contents of the
certification, including an acceptable certification statement.
Proposed Sec. 165.126(c) would specify that a certification be
submitted with each application for a new registration. For currently
registered pesticides, as proposed in Sec. 165.139, a certification
would be required to be submitted no later than 2 years after the date
of publication of the final rule in the Federal Register.
Section 165.128 would specify the container design recordkeeping
requirements for registrants. This section would apply to registrants
who distribute or sell pesticide product to refillers for refilling and
to registrants who distribute or sell pesticide product in refillable
containers. The records would have to be maintained for as long as the
registrant allows the container to be used; that is, for as long as the
container is identified on the registrant's list of acceptable
containers, and for 3 years thereafter. Registrants would be required
to make the records available for inspection and copying and to furnish
them upon request.
Section 165.128(a) would require that a description of the
container be a part of the records for all refillable containers. A
description of the container is necessary to link the records to the
actual containers. Specifically, the description would be required to
include, but not be limited to, the kind of refillable container
(liquid minibulk, liquid bulk, etc.), the model number of the
container, the container manufacturer, and the container's design type
parameters, including the structural design, size (capacity and
dimensions), material of construction, wall thickness, manner of
construction, and (for minibulks) pump fittings.
Proposed Sec. 165.128(b) would specify the records pertaining to
the drop test that would be required for dry minibulk or liquid
minibulk containers. For minibulk containers, the records would be
required to include at least one of three different kinds of records.
The first kind of record, as described in Sec. 165.128(b)(1)(i), would
be a copy of the test data, including a description of the test, a
description of the container tested, the test results, the date and
location of the test, and the test operators' names. ``A description of
the test'' would include the exact details of the drop test that was
performed, including which procedure was followed [i.e., the test
specified in Sec. 165.125(c), (d), or (e)], the drop height, and the
characteristics of the material that was used to fill the container for
the tests, such as the relative density of the material. The
description of the container is necessary to verify that the correct
container was tested. The rest of the information in proposed
Sec. 165.128(b)(1)(i), i.e., the test result, the date and location of
the test, and the test operators' names, is similar to the type of
information included in the recordkeeping specified by DOT's HM-181,
specifically in 49 CFR 178.601(k). As discussed in Unit V.B.7 of this
preamble, the test records would have to include the results of failed
tests of the same design type.
Two other kinds of records are included to allow the registrant
flexibility. EPA does not expect that all registrants will do the drop
test themselves. Therefore, Sec. 165.128(b)(1)(ii) would specify that a
letter from the container manufacturer would be acceptable. Similarly,
Sec. 165.128(b)(2)(iii) would specify that a letter from the facility
that conducted the test would be acceptable. The letters would be
required to contain much of the same information as that specified for
the first kind of record, including the specific test type, a
description of the container, and the test results. Instead of
including the date and location of the test and the test operators'
names, the letters would be required to specify the location of the
original test data.
Section 165.128(b)(3) would specify that EPA reserves the right, on
a case by case basis, to require submission of the drop test data. EPA
considers these data necessary to maintain a registration under FIFRA
section 3. Therefore, while registrants would not be required to
maintain a copy of the test data, registrants would still be
responsible for assuring that they could obtain the data so that they
could submit the data to EPA, if required to do so. Since the testing
must be done according to the GLP standards, EPA would also have the
right to inspect the testing facility and copy the data under 40 CFR
160.15. If EPA were denied access to the testing facility or the data,
then EPA would not consider the test data reliable for supporting the
registration.
Proposed Sec. 165.128(b)(2) would require that the registrant keep
a statement of compliance or noncompliance with respect to the GLP
standards, as described by 40 CFR 160.12, with the drop test records.
Similar to the approach for the residue removal data (as discussed in
Unit IV.B.9 of this preamble), EPA is considering requiring registrants
to submit the GLP statement of compliance or noncompliance for the drop
testing. As in Unit IV.B.9 of this preamble, EPA requests comments on
whether the GLP statement of compliance or noncompliance should be kept
with the drop test records as proposed, or submitted to EPA.
10. Transfer of registered pesticide products into refillable
containers. FIFRA section 3(a) provides in pertinent part that ``... no
person ... may distribute, sell, offer for sale, hold for sale, ... to
any person any pesticide which is not registered with the
Administrator.'' Registration is the principal means of ensuring that a
product is brought under the FIFRA regulatory scheme. The registrant
must demonstrate to EPA's satisfaction that the product meets the
statutory criteria for registration with respect to composition,
labeling, and the lack of unreasonable adverse effects. The registrant
must take responsibility for quality control of the product's
composition and for adequate labeling describing the product, its
hazards, and its uses. Repackaging of a pesticide produces a new
pesticide product that must be registered before it can be distributed
or sold.
In 1977, EPA issued an enforcement policy for bulk shipments of
pesticides. The policy describes certain conditions in which EPA allows
the transfer and repackaging of bulk pesticides to occur without
requiring registration of the repackaged pesticides (Ref. 63). The 1977
Bulk Pesticides Enforcement Policy (the Policy) defined ``bulk'' for
the purposes of the Policy as ``any volume of pesticide greater than 55
gallons or 100 pounds held in an individual container.'' EPA developed
the Policy to accommodate business practices of manufacturers and
distributors who handle pesticides in large undivided quantities rather
than in small individual containers because EPA believed:
(1) The need to properly dispose of excess numbers of containers
would be reduced.
(2) Less warehouse space would be required.
(3) Labor and handling costs would be reduced.
(4) Inventories could be more accurately controlled.
EPA also recognized that encouraging the use of refillable containers
would aid in minimizing waste.
In the Policy, EPA determined that repackaging of bulk pesticides
could occur without a separate registration if certain conditions were
met that would assure that the purposes of registration would be
satisfied. The conditions are that repackaging of the registered bulk
pesticides could involve nothing more than changing the product
container; i.e., no change in: (1) The pesticide formulation, (2) the
pesticide's labeling except to add an appropriate statement of net
contents and a registered establishment number, and (3) the identity of
the party accountable for the product's integrity.
The Policy elaborated on the accountability requirement. The
pesticide has to be: (1) Transferred at an establishment owned by the
registrant, (2) transferred at a registered establishment operated by a
person under contract with the registrant, or (3) transferred at a
registered establishment owned by a party not under contract to the
product registrant, but who had been furnished written authorization
for use of the product label by the registrant. The requirement for
written authorization assures that the registrant remains responsible
for quality control of the product's composition and adequate labeling
describing the product, its hazards, and its uses.
The 1977 Policy only addressed the transfer of a volume of
pesticide greater than 55 gallons or 100 pounds held in an individual
container. In March 1991, the Policy was amended to allow repackaging
of any quantity of pesticides into refillable containers, provided:
(1) The container is designed and constructed to accommodate the
return and refill of greater than 55 gallons of liquid or 100 pounds of
dry material.
(2) Either: (a) the containers are dedicated to and refilled with
one specific active ingredient in a compatible formulation, or (b) the
container is thoroughly cleaned according to written instructions
provided by the registrant to the dealer prior to introducing another
chemical into the container, in order to avoid cross-contamination.
(3) All other conditions of the July 11, 1977 Policy are met (Ref.
62).
Container disposal is a growing problem in some areas of the
country. The 1991 amendment to the Policy that allowed refillers to
repackage less than 55 gallons of product into containers with
capacities greater than 55 gallons was envisioned as a step toward
encouraging greater use of refillable containers and thus reducing the
number of containers for disposal.
In FIFRA section 19(e), Congress directed EPA to promulgate
container design regulations that facilitate safe reuse of containers,
thus indicating that Congress considered encouraging the use of
refillable containers important. Now that EPA is proposing container
design standards for refillables and requirements for refillers, EPA
believes it should expand the practice permitted by the Policy to allow
repackaging into any refillable container that meets the part 165
standards. Accordingly, EPA intends to replace the Bulk Pesticides
Enforcement Policy with Sec. 165.129. The proposed Sec. 165.129
provides that a registrant may allow a refiller to repackage the
registrant's pesticide product into any size refillable container and
to distribute or sell such repackaged product under the registrant's
registration, provided all conditions set out in the rule are met. In
other words, the refiller would not have to obtain a separate
registration to distribute or sell the repackaged product.
One of the proposed conditions is that the transfer of the
pesticide product into refillable containers must be done at a
registered establishment. This is based on the regulations at 40 CFR
part 167, governing registration of establishments, which require that
repackaging of pesticides occur at registered establishments.
Registrants, distributors, or dealers who deliver pesticides to farmers
or other end users are responsible for assuring that the site where the
transfer occurs is a registered establishment.
The proposed rule would not change the existing law; the Bulk
Pesticides Enforcement Policy would be replaced by a regulation. The
registrant would remain responsible for the integrity, labeling, and
packaging of the repackaged product. Both the registrant and refiller
may be held liable for violations pertaining to the repackaged
pesticide. For example, the registrant and the refiller both would be
responsible if the product was adulterated. Both the refiller and the
registrant would be the ``person'' who distributed or sold an
adulterated product. The registrant would be responsible because the
registrant authorized the refiller to repackage the pesticide. The
proposed requirements in Sec. Sec. 165.130 and 165.134 would address
the responsibilities of registrants and refillers for labeling,
container inspection, and residue removal. In order to assure the
registrant's accountability for the repackaged product, EPA is
considering adding to Sec. 165.129 a requirement that registrants
submit to EPA an acknowledgement that: (1) They have entered into a
repackaging agreement with a refiller and (2) they are responsible for
the integrity of the repackaged product.
The Bulk Pesticides Enforcement Policy would remain in effect until
the date specified for compliance in Sec. 165.139, at which point it
would be rescinded.
Proposed Sec. 165.129 would apply to registrants authorizing
distributors and/or dealers (refillers) to repackage the registrants'
registered pesticide products into refillable containers. Refillers
operating under contract to a registrant and refillers operating under
written authorization by a registrant would be regulated the same under
subpart G. Section 165.129 would not apply to registrants repackaging
their own pesticide products solely at their own establishments. Under
40 CFR 152.46(b), the registrant can modify the package size and label
net contents statement without notifying EPA. This would be an
amendment to the registration not requiring EPA notification or
approval.
As a result of recent compliance monitoring efforts, EPA has
received information that indicates there may be a significant
contamination problem with repackaged products. Despite considering it
desirable to encourage the use of refillable containers as outlined in
Unit V.B.8.a of this preamble, EPA may consider the alternative of not
allowing the practice of bulk repackaging to continue, and invites
comments and information on contamination incidents or other problems
associated with bulk repackaging. If registrants could not authorize
repackaging of their pesticides by refillers, then refillers would have
to obtain a registration to sell or distribute the repackaged product.
As producers, registrants and refillers are required to comply with
the section 8 recordkeeping and section 7 reporting regulations in 40
CFR parts 169 and 167, respectively.
11. Registrant responsibilities concerning refilling activities.
Section 165.130 would prescribe the requirements for registrants to
promote safe refilling and reuse of containers. These requirements
would include providing refillers with written authorization or a
written contract, developing a written refilling residue removal
procedure for each product, developing a written list of acceptable
containers for each product, and ensuring that the label and labeling,
residue removal procedure, and acceptable container list are available
at the establishments where the registrant's product is repackaged into
refillable containers.
Note that registrants also would be subject to the proposed
requirements in Sec. 165.134 for all refilling operations they conduct.
Additionally, repackaging by the registrant must be done at a
registered establishment, as required by 40 CFR part 167. Currently,
the Bulk Pesticides Enforcement Policy provides an exemption from the
requirement for the transfer of pesticides to be conducted at
registered establishments for registrants that deliver bulk pesticides
directly to commercial applicators, if the pesticides are metered off
into the applicator's tanks without being put into a dealer's holding
tank. EPA sees no reason to continue this exception from the registered
establishment requirement. Accordingly, when the Bulk Pesticides
Enforcement Policy is rescinded, this practice will no longer be
allowed. EPA requests comments on the effect of discontinuing this
exception.
The proposed Sec. 165.130(a) would set out the general
responsibilities of a registrant. Under Sec. 165.130(a)(1), a
registrant would be required to provide a written contract or a written
authorization to a refiller prior to distribution or sale of the
pesticide product to the refiller. The requirement for the written
contract or written authorization would not apply if the registrant of
the repackaged product is the sole refiller.
Proposed Sec. 165.130(a)(2) would hold the registrant responsible
for product integrity of the pesticide product repackaged by the
refiller under written authorization or contract. Product integrity
means that the pesticide product is not adulterated or different from
the composition as described in the statement submitted by the
registrant in connection with registration under section 3 of FIFRA.
This proposed requirement reflects current law. Under FIFRA section
12(a)(1), it is unlawful for any person to distribute or sell to any
person a pesticide which is adulterated or whose composition differs
from the composition described in the statement required in connection
with registration. Both the registrants and the refillers are selling
or distributing the product. The registrant is responsible because the
registrant has authorized the refiller to repackage the registrant's
pesticide product and to use the registrant's label according to the
terms of the written authorization or contract. The registrant remains
accountable for its repackaged product which is distributed or sold in
the refillable container.
Registrants have raised the issue of whether there should be an
exception from liability for adulteration or contamination of the
pesticide product if registrants can show that the adulteration or
contamination occurred solely because of actions or lack of actions by
the refiller. EPA believes it is appropriate for registrants to be held
responsible for acts by the refillers because the repackaging is being
done under the registrant's registration and the refillers are agents
of the registrants for purposes of carrying out the written
authorization or contract.
Proposed Sec. 165.130(b) would require registrants to develop
written procedures for residue removal from refillable containers in
preparation for refilling (the refilling residue removal procedure) and
written lists of acceptable containers. Both the residue removal
procedures and acceptable container lists would be product-specific.
Section 165.130(b) would apply to registrants who distribute or sell
pesticide products to refillers for repackaging into refillable
containers and to registrants who distribute or sell pesticide products
in refillable containers.
Under Sec. 165.130(b)(1), registrants would be required to develop
a written refilling residue removal procedure for each pesticide
product. The refilling residue removal procedure would describe the
procedures for removing pesticide residues from a container before it
is refilled with the registrant's product.
Proposed Sec. 165.130(b)(1)(i) would set the performance standard
for residue removal before refilling a container. Specifically,
Sec. 165.130(b)(1) would require the refilling residue removal
procedure to be adequate to ensure that the composition of the
pesticide does not differ at the time of its distribution or sale from
its composition as described in the statement required in connection
with its registration. To obtain a registration, applicants must submit
a statement of formula and product chemistry data that includes, among
other things, certified limits for active ingredients, inerts, and
impurities of toxicological significance (40 CFR part 158).
Additionally, any impurity that exceeds 0.1 percent by weight of the
active ingredient must be identified and the nominal concentration of
the impurity in the product must be furnished [40 CFR 158.155(d)].
If any impurity were to be introduced into the pesticide
formulation from some external source, such as the previous product in
the container, the result could be adulteration of the pesticide
product. Contamination from previous pesticide formulations is a
concern with refillable containers.
Contamination of pesticides from failure to clean out previously
held pesticides properly can lead to crop damage, residues exceeding
the tolerances, or illegal applications of pesticides to foods for
which there are no tolerances. This could lead to unanticipated risks
from the use of the pesticide. Also, such contamination from
mismanagement of refillable containers could be very costly, due to
reimbursing growers for crops that have been damaged and/or cannot be
sold.
In 1990, Iowa ran a pilot project in which dealers were allowed to
repackage less than 56 gallons of product into containers with
capacities of 56 gallons or larger (Ref. 32). As part of the project,
the Iowa Department of Agriculture and Land Stewardship sampled
representative minibulks to test the product repackaged into the
container for the presence of the active ingredient(s) previously in
the container.
Twelve minibulk containers were tested and 4 of the 12 were
determined to be contaminated (i.e., they contained active ingredients
other than those specified on the containers' labels). No contamination
from the previous active ingredient was detected in six samples.
Contamination of the active ingredient could not be determined in two
other samples, because the second pesticide product contained the same
active ingredient as the previous product. Of the four contaminated
samples, the active ingredient previously contained in the minibulk was
detected in two. The other two samples, both from the same dealer, were
contaminated with an active ingredient other than that of the
previously held product.
Despite the limited number of containers sampled, the Iowa project
shows that there can be a problem with contamination and product
integrity with refillable containers.
As a result of recent compliance monitoring efforts, EPA has
received information that indicates there may be a significant
contamination problem with repackaged products. The results of sampling
pesticides in refillable containers in Region 7 indicated that about 60
percent of the samples from bulk storage tanks contained contamination
and about 80 percent of the samples from minibulk containers contained
contamination (Ref. 7).
Contamination of a pesticide in the refillable container that
results from the container not being properly cleaned before refilling
would be a violation of FIFRA section 12(a)(1)(E) if the pesticide is
adulterated, or section 12(a)(1)(C) if the product composition differs
from the registered product.
Another possible source of contamination is the use of common
piping, pumps, meters and discharges hoses to distribute pesticide
product from bulk tanks. The Minnesota Department of Agriculture
conducted a survey of 40 refillers in Minnesota and found that 29 of
these facilities had dedicated (separate) plumbing systems, while 11
had common plumbing systems (Ref. 35). If the pipes, pumps, meters and
hoses are not properly purged between transfers, the residue from the
first product can contaminate the second product. EPA requests comments
on the potential contribution of common plumbing systems to
contamination and whether EPA should address plumbing systems in the
final rule.
Under proposed Sec. 165.130(b)(1)(ii), if the refilling residue
removal procedure requires the use of a solvent other than the diluent
used for application of the pesticide as specified on the label under
``Directions for Use,'' or if there is no diluent used for application
(examples: granules, some ultra-low-volume concentrates), the refilling
residue removal procedure would be required to describe how to manage
the rinsate resulting from the procedure in accordance with applicable
Federal and State regulations. The rinsate management instructions are
intended to encourage the reuse of rinsates by application in
accordance with label instructions, rather than having to dispose of
them. In situations where registrants recommend or require cleaning
with a solvent that would result in rinsate that could not be applied
to any labeled site, registrants would have to describe how to manage
that rinsate. An example of acceptable rinsate management instructions
for a solvent that can be reused to rinse containers would be:
``Collect the solvent solution in a designated container and reuse it
to clean other containers. After using the solvent to clean 25
containers, contact the registrant for disposal instructions.''
The requirement for a residue removal procedure in proposed
Sec. 165.130(b)(1) would apply only to cleaning the containers before
they are to be refilled. Residue removal prior to disposal (by users or
refillers) is addressed in the proposed modifications to labels in part
156 of this chapter (see the discussion in Unit VII.B.7 of this
preamble). Proposed Sec. 156.144(e)(2) would require registrants to
provide a label statement giving instructions on cleaning refillable
containers prior to disposal.
Proposed Sec. 156.144(e)(2) would allow the registrant a number of
options for a residue removal label statement, as long as the chosen
procedure is appropriate for the characteristics and formulation of the
pesticide product and is adequate to protect human health and the
environment, as provided in Sec. 156.144(e)(2)(ii).
One option under Sec. 156.144(e)(2)(iii)(A) would be the refilling
residue removal procedure developed by the registrant. EPA anticipates
that in most cases registrants would be able to use the same procedure
for residue removal both before refilling and prior to disposal,
although the language placed on the label for cleaning prior to
disposal would most likely be a condensed and simplified version of the
refilling residue removal procedure. EPA believes that residue removal
procedures sufficient to ensure that the product subsequently sold in a
container would not differ from its composition as described as a
condition of registration most likely would clean containers well
enough to be safely disposed, whether that would be recycling,
incinerating, landfilling, or another management option. EPA
anticipates that the procedures proposed by registrants for the label
would generally provide for triple rinsing or the equivalent degree of
pesticide removal from refillable containers.
Under Sec. 156.144(e)(2)(iii)(B), registrants also could base their
label language on standard industry practices that they use to prevent
adulteration during refilling, as long as the general standard is met.
Proposed Sec. 156.144(e)(2)(iii)(C) includes a potentially
acceptable label statement for residue removal from refillable
containers prior to disposal. EPA developed this statement by compiling
key components of current industry practices. The residue removal
procedure described in Sec. 156.144(e)(2)(iii)(C) would include filling
the container 10 percent full with water, agitating the container
vigorously or recirculating the water with the pump, emptying the
container and repeating the process two more times. This procedure
involves rinsing the refillable container three times, although it is
different from the description of triple rinsing for nonrefillable
containers as proposed in Sec. Sec. 156.144(d)(1)(ii)(A) and (iii)(A).
EPA believes that the procedure for cleaning refillable containers in
proposed Sec. 156.144(e)(2)(iii)(C) would provide for triple rinsing or
the equivalent degree of pesticide removal from the refillable
container.
Finally, the registrant could propose a different residue removal
statement that the registrant considers appropriate.
The proposed approach for cleaning refillable containers before
disposal is different from that of nonrefillable containers. At this
time, EPA is not proposing to set a numerical performance standard for
the amount of residue that can remain in a refillable container. EPA
does not have sufficient information on the amount of residue remaining
after refillable containers are cleaned. Also, currently there are no
established, standardized refillable container cleaning procedures
which would assist in developing the data to set a laboratory
performance standard.
The situation with refillable containers does not parallel that
with nonrefillables because of the larger range of sizes for the
refillable containers that may be used to distribute or sell the
pesticides. The effectiveness of cleaning a container, if measured by
the concentration of pesticide in the rinsate, depends on the amount of
product retained when the container initially is emptied. The amount of
product retained depends, in part, on the internal surface area of the
container, which is related to the container size. Different procedures
may be necessary or appropriate, depending on the size of the
containers. For example, residue removal procedures for cleaning a 110-
gallon liquid minibulk container may not be appropriate for a 10,000-
gallon liquid bulk container. Similarly, a given residue removal
standard may be appropriate for a limited range of container sizes. For
example, EPA expects that larger nonrefillable containers, such as
drums, may have difficulty meeting the residue removal standard in
Sec. 165.104. (See the discussion in Unit IV.B.7 of this preamble).
EPA also anticipates that, unlike nonrefillable containers, many
plastic refillable containers will be incinerated rather than recycled.
Metal refillables can be recycled at steel reclamation facilities.
Because the incineration of plastic containers and the recycling of
metal containers occur at high temperatures that offer a high degree of
pesticide destruction, the amount of pesticide remaining in the
containers may not be as crucial.
Unit VII.B.4.a of this preamble discusses the proposed label
statement that would require end users to rinse nonrefillable
containers immediately after emptying out the useful contents of the
container. EPA is not proposing to require cleaning refillable
containers immediately upon emptying the useful contents. It may not be
practical to require refillables to be cleaned immediately since the
refillers, the parties required to clean the refillable containers, are
generally not the people emptying the containers. In addition, EPA is
not as concerned about pesticide product drying inside a refillable
container because the container should remain closed until the refiller
is ready to clean and/or refill it.
Therefore, EPA believes it is appropriate to regulate residue
removal from refillable containers differently than residue removal
from nonrefillable containers, and specifically, not to set a
performance standard for refillable containers at this time. However,
EPA also believes that refillable containers, like nonrefillables,
should be designed to facilitate draining and residue removal. To
accomplish this, EPA is considering the development of a laboratory
residue removal procedure and a numerical standard for refillable
containers. EPA requests comment on the appropriateness of the proposed
approach to regulating residue removal from refillable containers
before disposal. EPA also solicits comments on the possibility of
setting a numerical residue standard for refillable containers and
suggestions for developing such a standard.
Proposed Sec. 165.130(b)(2) would require registrants to develop a
written list of acceptable containers (bulk and minibulk) for each
registered product. Proposed Sec. 165.130(b)(2)(i) would specify that
acceptable containers would be those that the registrant has identified
as meeting the standards in Sec. 165.124 and being compatible with the
pesticide formulation to which the written list of acceptable
containers applies. Registrants would have to determine which
containers would be compatible with each formulation so as to reduce
the possibility of an adverse interaction between the formulation and
container. Product-specific lists of acceptable containers would be
required because of the requirement for the container and formulation
to be compatible.
The concept of compatibility between a container and formulation is
the same for refillable and nonrefillable containers and is discussed
in Unit IV.B.3 of this preamble.
Section 165.130(b)(2)(ii) would require the registrant to identify
the containers by specifying, at a minimum, the container's
manufacturer and model number. This scheme of specifying containers
would provide a relatively simple way for registrants, refillers, and
inspectors to identify containers.
The proposed definition of container in Sec. 165.3 would include
some spray applicator tanks. EPA has received reports that some
refillers transfer product directly into farmers' spray applicator
tanks. Under the proposed regulation, this practice could take place
only if a farmer's spray applicator tank was included on a registrant's
written list of acceptable containers. EPA believes that it is unlikely
that a registrant would include spray applicator tanks on a list of
acceptable containers. EPA is considering prohibiting registrants from
including spray applicator tanks on their written list of acceptable
containers because EPA does not believe that having a refiller
repackage product directly into a farmer's spray applicator tank is a
safe practice. EPA requests comments on whether the regulations should
be revised to prohibit registrants from including spray applicator
tanks on their list of acceptable containers.
Proposed Sec. 165.130(c) would require registrants to provide
certain documentation to refillers. Specifically, a registrant whose
pesticide product is repackaged by a refiller into refillable
containers would be required to provide refillers with all of the
documentation described in Sec. 165.130(c)(2). A registrant would be
required to provide the documentation before or at the time of sale or
distribution of the pesticide product to the refiller.
By proposed Sec. 165.130(c)(2), a registrant would be required to
provide a refiller with: (1) The written refilling residue removal
procedure for the pesticide product; (2) the written list of acceptable
containers for the product; and (3) the pesticide product's label and
labeling.
The requirement for the registrant to provide labels and labeling
to refillers would help ensure that the end user receives relevant
product information. The refiller would attach the label to the
container into which the product is repackaged. Refillers would need a
copy of the label and labeling for each container used to distribute or
sell the registrant's product.
The other documentation, i.e., the refilling residue removal
procedure and the list of acceptable containers, would be required to
be provided to refillers to ensure that the refillers have the
information necessary to refill and reuse the containers safely.
12. Registrant recordkeeping and inspection. Section 165.132 would
specify the recordkeeping requirements for registrants. The specific
recordkeeping requirements would be different for registrants who
distribute or sell pesticide products in refillable containers (i.e.,
those who refill themselves) and registrants who distribute or sell
pesticide products to refillers for repackaging into refillable
containers. A distinction is made between these two groups because
different records and different lengths of time for record retention
are appropriate for each group. However, in both cases, the registrants
would be required to make the records available for inspection and
copying and to furnish them to EPA upon request.
By Sec. 165.132(a), a registrant who distributes or sells a
pesticide product to a refiller for repackaging into refillable
containers would be required to maintain the records for as long as the
pesticide is distributed or sold to a refiller, and for 3 years
thereafter. These registrants would be required to maintain copies of:
(1) Each written authorization or written contract provided to a
refiller for repackaging the registrant's pesticide product into
refillable containers, (2) the written refilling residue removal
procedure for the pesticide product, and (3) the written list of
acceptable containers for the pesticide product.
Section 165.132(b) would require a registrant who distributes or
sells a pesticide product in refillable containers to maintain the
records for as long as the registrant distributes or sells the product
in refillable containers, and for 3 years thereafter. These registrants
would maintain the same records, except for the written authorizations.
13. Refiller responsibilities and procedures. Section 165.134 would
set out the responsibilities of a refiller that are intended to ensure
a sufficient degree of product and container integrity. EPA is
proposing these procedural requirements for refillers because the
refillers are actually doing the refilling and container handling.
The requirements of Sec. 165.134 would apply to all refilling
operations, which could include any of the following situations: (1) A
registrant refilling a container for a refiller who is operating under
contract to or authorization from that registrant, (2) a refiller
operating under contract to or authorization from a registrant
refilling a container for an end user (regardless of the establishment
where that refilling takes place), and (3) a registrant refilling a
container for an end user (regardless of the establishment where that
refilling takes place). EPA requests comments on whether the proposed
requirements are appropriate in all of these situations.
Custom blenders provide the service of mixing pesticides with
fertilizer, feed, or another pesticide to a customer's specification.
(See 40 CFR 167.3). Custom blenders that fill refillable containers at
the end user's request with a blended mixture of pesticide would be
refillers under subpart G and subject to the refiller responsibilities
and procedures in Sec. 165.134. Although EPA has limited information
about the practices of custom blenders, EPA recognizes that some of the
proposed requirements in Sec. 165.134 may cause problems for custom
blenders. For example, custom blenders may blend a pesticide that they
obtained in nonrefillable containers, and therefore the registrant may
not have developed a list of acceptable containers or written residue
removal procedures.
For the final rule, EPA is considering two options: (1) Issue a
regulation on refilling practices that is tailored specifically to
custom blenders that distribute pesticide mixtures, or (2) exempt
custom blenders from the requirements of subpart G. The latter option
would be consistent with EPA's past practice. Currently, custom
blenders are exempted from the establishment registration requirements
and the production reporting requirements in part 167. However, custom
blenders that fill refillable containers with blended pesticides for an
end user are performing activities very similar to dealers that are
repackaging pesticides into smaller refillable containers for end use.
EPA has the same concerns about contamination of the repackaged
pesticide, and the integrity of the container for custom blends as for
other pesticides being repackaged in refillable containers.
Additionally, custom blenders would be subject to the secondary
containment requirements being proposed in subpart H. EPA requests that
commenters provide information on how the requirements of Sec. 165.134
could be revised to address the specific practices of custom blenders.
If the final rule regulates the refilling practices of custom
blenders and requires that the repackaging of the pesticide by custom
blenders occur only at registered establishments, Sec. 167.20, which
exempts custom blenders from the establishment registration
requirement, would be amended to be consistent with the part 165
requirements.
Section 165.134(a) would require a refiller to possess certain
items from a registrant before repackaging the registrant's pesticide
product into refillable containers. These items include the written
authorization or contract and other information that the registrant
would be required to provide to the refiller as specified in
Sec. 165.130. Registrants and refillers would be jointly responsible
for the exchange of these items; registrants would be responsible for
providing them and refillers would be responsible for obtaining them.
By proposed Sec. 165.134(a), a refiller would be required to
possess: (1) The written authorization or contract from the pesticide
product's registrant, if required, (2) the product's label and
labeling, (3) the registrant's written refilling residue removal
procedure for the pesticide product, and (4) the registrant's written
list of acceptable containers for the pesticide product.
The written authorization or contract would be required if the
refiller is repackaging the pesticide product for the registrant under
the conditions of Sec. 165.129. A written authorization or contract
would not be required if the registrant of the product is the refiller,
as discussed in Unit V.B.11 of this preamble.
These items are necessary for different reasons. As discussed
earlier, a written authorization or a written contract is necessary for
the refiller to be able to rely on the registrant's registration to
repackage the registrant's pesticide product for distribution or sale.
Requiring the refillers to obtain the product's labeling would assure
that the label for the registered products would be available for the
refilled container. The written refilling residue removal procedure for
the pesticide product would provide instructions so that the refiller
would know how to clean the containers. The written list of acceptable
containers is necessary so the refiller would know which containers
could be used for repackaging a registrant's product.
Section 165.134(b) would clarify that a refiller is responsible for
the product integrity of the pesticide product that the refiller
repackages into refillable containers. By product integrity, EPA means
that the pesticide product must not be adulterated or differ from the
composition as described in the registrant's statement submitted in
connection with registration under section 3 of the Act. Refillers
would be responsible for product integrity in addition to the
registrants, as specified in Sec. 165.130(a)(2).
EPA considered exempting refillers from responsibility for the
product integrity under a narrow range of conditions. Specifically, EPA
considered an exemption from responsibility for product integrity if
the refiller could show that it repackaged the product into a container
on the registrant's list of acceptable containers for the product,
followed the registrant's refilling residue removal procedure for the
product, and complied with the requirements of Sec. 165.134, including
the container inspection procedure at Sec. 165.134(e). If these
conditions were met, the refiller would have done everything according
to the registrant's instructions. However, EPA rejected this idea. Even
if the refiller followed the registrant's instructions and complies
with the regulations, there could be other actions a refiller should
have taken or refrained from taking to avoid contamination.
Additionally, EPA believes that holding refillers responsible for
product integrity for all repackaged product would improve product and
container stewardship. EPA requests comments on the refiller's proposed
responsibility for product integrity and on the exemption therefrom
considered by EPA.
Proposed Sec. 165.134(c) would set out several general conditions
that a refiller must meet. Section 165.134(c)(1)(i) would require
refillers to repackage a pesticide product only into a refillable
container that is identified on the registrant's list of acceptable
containers for that product. This requirement is included for
enforcement purposes. If a refiller repackages a registrant's product
into a container that is not on the list of acceptable containers, the
refiller would violate proposed Sec. 165.134(c)(1)(i).
Proposed Sec. 165.134(c)(1)(ii) would prohibit refillers from
changing the pesticide formulation, unless the refiller has a
registration for the new formulation. Refillers operating under written
authorization or contract from a registrant would not be allowed to
change the formulation, which is consistent with proposed
Sec. 165.129(a).
Section 165.134(c)(2) would refer refillers to the potentially
applicable standards for secondary containment units and containment
pads located in proposed subpart H of part 165. EPA believes that
secondary containment structures and containment pads are necessary for
the safe reuse and refill of containers, as described in Unit VI.A of
this preamble, the background discussion for subpart H. As discussed
briefly in Unit V.B.6 of this preamble, the scope and applicability of
subpart G (refillable containers) and subpart H (containment
structures) are different. For example, the requirements of proposed
Sec. 165.134 would apply to refillers, which include both registrants
and pesticide retailers. However, proposed Sec. 165.141(b) would
specify that subpart H applies to refilling establishments whose
principal business is retail, i.e., only a subset of refillers'
facilities.
Section 165.134(d) would require a refiller to identify the
pesticide product previously contained in the refillable container. The
refiller could identify the previous product by reference to the label
or labeling. The purpose of this requirement is to determine whether a
residue removal procedure would have to be conducted according to
Sec. 165.134(g).
Section 165.134(e) would require refillers to inspect each
refillable container before repackaging a pesticide product into that
container. Container inspections would promote the refilling of sound
containers, which is necessary for safely refilling and reusing
containers. The container design standards, such as the drop test for
minibulks, would ensure that the containers had a certain minimum
degree of strength. However, having a container design type that passes
the relevant drop test does not ensure that a container will remain
sound after years of use.
The condition and integrity of a refillable container may be
affected by factors specific to that container and its history, such as
the original design, the material(s) of construction, storage and
handling conditions, and exposure to sunlight, precipitation, and
temperature extremes. Industry representatives and container users have
expressed concern regarding the effect of ultraviolet light on the
integrity of plastic refillable containers that are exposed to sunlight
for extended periods of time. Ultraviolet light can cause stress
cracking on the surface of plastic containers and can cause the
containers to become brittle.
EPA believes that the inspection of containers each time they are
refilled is necessary to detect problems with each specific container.
Section 165.134(e) would specify the conditions under which a container
would fail an inspection. The inspection primarily would be to make
sure the container does not have any major structural problems. The
person doing the inspection would not need to be a packaging expert.
The visual inspection would be expected to consist of at least the
following three steps. First, the exterior and interior (if possible)
of the refillable container and the exterior of the appurtenances would
be visually inspected for signs of corrosion or ultraviolet light
damage; structural defects, such as cracks, holes, dents, defective
welds, or weakened welds; and damage to the fittings, valves, tamper-
evident devices, or other appurtenances that could affect the integrity
of the container. Second, the exterior of the container would be
visually inspected to determine if the information proposed to be
marked permanently on the container in Sec. 165.124(b) is present and
legible. Third, liquid minibulk containers would be visually inspected
to determine if each appurtenance has an intact and functioning one-way
valve and/or a tamper-evident device.
Proposed Sec. 165.134(e) would prohibit a refiller from repackaging
product into a refillable container that fails the inspection.
Paragraphs 165.134(e)(1)(i) through (e)(1)(iii) set out the conditions
that define how a container fails the inspection.
By proposed Sec. 165.134(e)(1)(i), a container would fail the
inspection if there is significant corrosion or ultraviolet light
damage. The term ``significant'' is included to differentiate between
small rust spots and an amount of corrosion or ultraviolet light damage
that could cause the container to leak under a reasonably expected
jolt, such as a drop of several inches on its base.
Under proposed Sec. 165.134(e)(1)(ii), a container would fail the
inspection if there are structural defects including, but not limited
to, significant cracks, visible holes, bad dents, defective welds, or
weakened welds. Again, ``significant'' is included to differentiate
minor surface stress cracks from cracks that compromise the ability of
the container to hold the product. ``Visible holes'' could cause
product to leak from the container; these are different from tiny
pinholes that are not visible. ``Bad'' is included to differentiate
between minor indentations and dents that may indicate that the
container may not be able to contain the product. A similar criterion,
i.e., whether or not the container could hold product under reasonably
foreseeable conditions, can be applied to determine if welds are
``defective'' or ``weakened.''
By Sec. 165.134(e)(1)(iii), a container would fail the inspection
if there is damage to any of the fittings, valves, tamper-evident
devices, or other appurtenances that could affect the integrity of the
container. The criterion of whether or not the container could hold
product under reasonably foreseeable conditions can be applied to
determine if there has been damage that would cause the container to
fail the inspection.
By Sec. 165.134(e)(2), a container would fail the inspection if the
information required in Sec. 165.124(b) to be permanently marked on the
refillable container is not legible or is not permanently marked on the
refillable container. This criterion for failing the inspection is
included because if this information is not readily available, the
refiller may not have the information necessary to refill and reuse the
container safely. This part of the inspection also would affirm that
the container meets the Sec. 165.124 container design requirements.
Under Sec. 165.134(e)(3), a container would fail the inspection if
the refillable container is a liquid minibulk container and it does not
have an intact and functioning one-way valve or a tamper-evident device
on each aperture.
EPA understands that many of the proposed criteria for defining
when a container fails the inspection, such as ``significant corrosion
or ultraviolet light damage,'' ``significant cracks,'' and ``bad
dents'' are subjective. EPA requests comment on whether the proposed
criteria are appropriate and whether they are written in a manner that
can distinguish between containers that are and are not acceptable to
be refilled.
A part of the container inspection procedure would include looking
at the date of manufacture of the container, which would be required as
permanent marking. Under proposed Sec. 165.134(f), a refiller would be
prohibited from repackaging pesticide product into a plastic liquid
minibulk container more than 6 years after the date of manufacture of
the container, which would limit the lifetime of these containers. The
6-year limit is intended to give plastic liquid minibulks a year to get
into the pesticide distribution chain and a 5-year lifetime.
EPA is concerned about the long-term durability of plastic minibulk
containers. From many discussions with industry representatives, 5
years is generally accepted as a ``safe'' lifetime of one of these
containers. As discussed in the Report to Congress (Ref. 65), many
minibulk containers have been in the field successfully for 5 years
(since the late 1980s). However, after that point, the integrity of the
container is questionable. Several registrants have instituted programs
to pull the 1980s models from the field and replace them with new
minibulks.
Limiting the lifetime of plastic minibulks is consistent with the
recommendations in both the MACA-75 voluntary industry standards and
U.N. Recommendations for rigid plastic IBCs. For example, section
16.4.11.1 (regarding specific requirements for rigid plastic IBCs) of
the U.N. Recommendations (Ref. 76) states, ``Unless otherwise approved
by the competent authority, the period of use permitted for the
transport of dangerous liquids should be five years from the date of
manufacture of the receptacle except where a shorter period of use is
prescribed because of the nature of the liquid to be transported.''
EPA is considering incorporating into the regulations a waiver that
would allow plastic liquid minibulk container design types to be used
for longer than 6 years. The waiver would be for a specific time period
based on information submitted by the registrant. It is possible that
future plastic liquid minibulk containers may be significantly better
than current designs due to improvements in technology, such as a new
resin or a different manufacturing method. To EPA's knowledge, nearly
all plastic liquid minibulk containers are constructed of linear high
density polyethylene (HDPE) or cross-linked HDPE and are manufactured
by either a blow molding process or a rotational molding process. It is
possible that a change in either the plastic resin used and/or the
manufacturing process could lead to a significant change in the
sturdiness and durability of the containers.
Some of the potential criteria EPA could use for evaluating
requests for waivers from the 6-year lifetime limit include whether the
container design type: (1) is constructed of a plastic resin other than
linear HDPE or cross-linked HDPE that can be shown to be more durable
and sturdy; (2) is manufactured by a process other than blow molding or
rotational molding that can be shown to be more durable and sturdy; or
(3) utilizes some other advance that contributes to a significant
increase in the sturdiness and durability of the containers. In
addition, EPA would expect the registrant to provide data, a revised
container lifetime expectancy and a justification for the different
life span. EPA would have to review and approve the waiver before the
design type could be added to the registrant's list of acceptable
refillable containers. EPA requests comments on whether such a waiver
should be included in the final rule and, if so, whether the approval
criteria discussed above are appropriate or if they should be modified.
EPA is also considering an option of allowing plastic liquid
minibulk containers to be tested after the 6-year lifetime has expired
in order to extend the useful life of the container. EPA realizes that
a container that is handled carefully and protected from detrimental
conditions (such as extremely hot temperatures, freezing conditions,
precipitation and sunlight) may be able to continue to be used safely
for more than 6 years. Specifically, EPA is considering incorporating a
test procedure similar to the DOT retest procedure set out in 49 CFR
173.32(e). Section 173.32(e) of the DOT hazardous materials regulations
specifies that a pressure test and a visual inspection of the container
under pressure be conducted at a specified time interval (every 1, 2 or
5 years depending on the container type). The pressure test specified
in the DOT regulations is a relatively simple and inexpensive test that
utilizes a small air compressor (if air is to be used) or the existing
water line (if water is to be used) to increase the pressure inside the
container. The person who conducts the test must mark the test data on
the container and maintain records of the test until the next test
date.
EPA requests comments on whether a similar test procedure should be
incorporated into the final rule as a means to extend the life of
individual plastic liquid minibulk containers. EPA also requests
comments on the details of the test, such as: (1) Who should be allowed
to conduct the testing (registrants and/or refillers?); (2) how long
should the life of a container be extended if it passes the test (e.g.,
one or two years?); and (3) how should the extension of the container
lifetime be indicated on the container? (e.g., should the test date be
marked on the container or should a notation that specifies the ``new''
expiration date be marked on the container?).
Section 165.134(g) would require the refiller to follow appropriate
refilling residue removal procedures. This section describes the
situations in which a refiller would have to clean containers before
using them for repackaging pesticide products. Refillable containers
would not always have to be cleaned before they are refilled. However,
EPA is concerned that the pesticide product being repackaged into the
container could become contaminated with impurities from previously
contained products. EPA believes that specifying the conditions under
which a refillable container needs to be cleaned would help minimize
the potential for contamination. Also, specifying these conditions
would set out consistent ground rules for when the refilling residue
removal procedures would need to be conducted, which would benefit
refillers.
EPA also would like to minimize the amount of rinsate that is
generated, which is consistent with EPA goals of waste minimization and
pollution prevention. Management or disposal of the rinsate can be
burdensome to a refiller. EPA believes that minimizing the cleaning of
containers may help encourage refillable containers because it would be
less burdensome for refillers in terms of rinsate management and
handling costs. On the other hand, a desire to minimize container
cleaning is secondary to maintaining the integrity of the products.
When EPA amended the Bulk Pesticides Enforcement Policy in 1991 to
allow repackaging of any quantity of pesticide product, EPA was
concerned about contamination of the products sold in refillable
containers (Ref. 62). To address this concern, the policy allows the
repackaging of any quantity of a pesticide product into refillable
containers, provided that either:
(1) The containers are dedicated to and refilled with one specific
active ingredient in a compatible formulation, or
(2) The container is thoroughly cleaned according to written
instructions provided by the registrant to the dealer prior to
introducing another chemical to the container in order to avoid cross-
contamination. EPA proposes to follow this approach in Sec. 165.134(g),
with some expansion.
Section 165.134(g)(1) would specify that a refiller would have to
conduct the pesticide product's refilling residue removal procedures
before repackaging the pesticide product into a refillable container,
except under the conditions specified in Sec. Sec. 165.134(g)(1)(i) -
(iii). In general, refillers would be required to clean containers in
situations other than those where a container previously held a product
with a single active ingredient and is being used to repackage a
product with the same active ingredient.
If the three conditions specified in Sec. Sec. 165.134(g)(1)(i)-
(iii) are met, a refiller could repackage product into the container
without conducting the refilling residue removal procedure.
The first condition would be that each tamper-evident device is
intact, if the refillable container has a tamper-evident device. An
intact device would provide reasonable assurance to the refiller that
the container had not been tampered with, and had contained only the
product identified on the label.
The second condition would be that the container previously held a
product with a single active ingredient and is being used to repackage
a product with the same single active ingredient.
The third condition would be that there is no reaction or
interaction between the product being repackaged and the residue
remaining in the container that would cause the composition of the
product being repackaged to differ from its composition as described in
the statement required in connection with its registration under
section 3 of the Act.
Under the second and third conditions, a container could be
refilled with the same product as it previously held or with a product
that has the same active ingredient ``in a compatible formulation,'' as
specified in the 1991 amendment to the Bulk Pesticide Enforcement
Policy.
EPA considered specifying other situations in which the refilling
residue removal procedure would not have to be conducted. For example,
if the original product contains one active ingredient and the
container is to be refilled with a product with two active ingredients,
including the one in the original formulation, there should be no
contamination of the active ingredients. In this case, if the
conditions in proposed Sec. Sec. 165.134(g)(1)(i) and (iii) were met,
it may be that the container would not need to be rinsed. Nevertheless,
to ensure product integrity, EPA is proposing a limited universe of
situations where refilling is allowed without cleaning the container.
In particular, EPA is concerned about the effect the inert ingredients
may have in causing the product being sold in the refillable container
to differ from the registered product.
Proposed Sec. 165.134(g)(2) would state that in addition to
conducting the refilling residue removal procedure, in all cases where
the container has a broken (not intact) tamper-evident device, other
procedures may need to be taken to assure that product integrity is
maintained. EPA is concerned that the refilling residue removal
procedure may not be thorough enough, because with broken tamper-
evident devices, a refiller would have no reasonable assurance about
the identity of the container's previous contents. The container may
have been used to store a substance other than a pesticide, such as
gasoline or motor oil. EPA anticipates that refilling residue removal
procedures developed by registrants will not be designed to account for
situations such as these.
EPA considered another option for cleaning containers with broken
tamper-evident devices. EPA considered requiring the refiller to
identify the container contents by sampling the residue remaining in
the container, to clean the container if necessary, and to verify that
the container has been sufficiently cleaned by sampling the residue in
the container. EPA rejected this option because the refillers may not
have the expertise to conduct the testing of the samples drawn from the
residue and the testing could be costly. In addition, EPA does not have
sufficient information to set a standard for what would be considered
``sufficiently clean.''
EPA requests comments on whether additional procedures beyond those
set out in Sec. 165.134(g) are needed to clean containers with broken
tamper-evident devices.
Regardless of whether the container would be required to be cleaned
or not, the product distributed or sold in the refillable container
must not be contaminated so that it differs from the composition of the
registered product, as discussed earlier. EPA is concerned that there
may be a problem with the conditions proposed in Sec. 165.134(g) if a
container previously holding a product with a high concentration of one
active ingredient is to be refilled with a product having a
significantly lower concentration of the same active ingredient. Such a
container would not be required to be cleaned under the proposal (if
the formulations were compatible and the container's tamper-evident
devices were intact). The second formulation could differ from its
composition defined in the registration statement not by a different
active ingredient, but by the higher concentration that may result. In
this case, the active ingredient may exceed its certified limits and
could be subject to enforcement. EPA requests comments on the potential
problem of significantly different concentrations of the same active
ingredient.
EPA also requests comments on whether the proposed conditions for
conducting the refilling residue removal procedures are appropriate.
The proposed conditions in Sec. 165.134(g) would apply to all types of
refillable containers, as specified in the proposal. EPA requests
comments on whether it is appropriate to subject liquid bulk containers
to the same conditions as liquid minibulk containers.
Section 165.134(h) would allow a refiller to repackage any quantity
of pesticide product into a refillable container up to the rated
capacity of the container. Currently, under the Bulk Pesticides
Enforcement Policy, refillers can only repackage registered pesticide
products into containers with capacities greater than 55 gallons liquid
or 100 pounds of dry material. EPA believes that any container that
meets the requirements of Sec. 165.124 can be safely refilled and
reused, regardless of the capacity of the container.
Smaller refillable containers are desirable for the many
applications that do not require 55 gallons of pesticide, such as
treatments of small fields and uses of pesticides that are applied at
low rates. Smaller refillables may become increasingly important if the
trend toward selling more highly concentrated pesticide formulations
continues.
The provision to allow the repackaging of any quantity of product
into a refillable container should lead to increased use of refillable
containers, thereby decreasing the number of nonrefillable containers
requiring disposal.
EPA believes that by allowing any quantity of product to be
repackaged into acceptable containers and not defining a minimum
capacity for refillable containers, EPA will encourage the use of
refillable containers. EPA requests comment on whether this is an
accurate assessment of the effect of loosening the quantity
restrictions involved with refilling.
Section 165.134(i) would require a refiller to label the refilled
container properly. A refiller would be required to securely attach the
new label. The label would have to be attached in such a manner that
the label can reasonably be expected to remain affixed during the
foreseeable conditions and period of use. EPA expects that a refiller
would first remove the previous label and labeling, if any, to ensure
that the pesticide product is not misbranded. The refiller would be
attaching labels provided by the registrant of the pesticide product
which is being repackaged. To comply with the labeling requirements of
Sec. 156.10, the refiller would include the EPA assigned establishment
number and the net contents statement. A pesticide product is
considered misbranded if its label does not bear the registration
number, assigned under section 7, of the establishment in which it was
produced [FIFRA sec. 2(q)(1)(D)]. Also, it is misbranded if the net
weight or measure of the contents is not affixed to the container
[FIFRA sec. 2(q)(2)(C)(iii)]. The proposed blank spaces on the label
would accommodate this information.
14. Refiller recordkeeping and inspection. Section 165.136
describes the records that a refiller would be required to maintain.
Section 165.136(a) would require a refiller to maintain copies of the
agreement and information obtained from each product's registrant.
These records would be required to be maintained for as long as the
refiller distributes or sells a pesticide product in refillable
containers, and for 3 years thereafter. By proposed Sec. 165.136(a), a
refiller would be required to maintain copies of: (1) The written
contract or written authorization from the registrant of the pesticide
product, as described in Sec. 165.129(a), (2) the registrant's written
refilling residue removal procedure for the pesticide product, and (3)
the registrant's written list of acceptable containers for the
pesticide product.
Section 165.136(b) describes the records that a refiller would be
required to maintain each time a refillable container that has been
used to distribute or sell a pesticide product is delivered to the
refiller to be refilled. By proposed Sec. 165.136(b), the information
would include the name and address of the person providing the
refillable container, the serial number of the container, the date the
container was received, and the name and EPA registration number of the
pesticide that was last distributed or sold in the refillable
container.
These records would create a link between the container and the
previous formulation sold in the container. These records, in addition
to the records specified in proposed Sec. 165.136(c) which would link
the container to the next product repackaged into it, would help assure
the safe refill and reuse of containers. EPA believes the records in
proposed Sec. Sec. 165.136(b) and (c) would minimize the potential for
contamination of the product sold or distributed in the container and
make the regulations more easily enforceable. For example, whether or
not a refillable container needs to be cleaned depends on both the
previous product and the product to be repackaged in that particular
container. In general, the records in Sec. Sec. 165.136(b) and (c) are
intended to ensure that a refiller effectively manages, handles, and
tracks containers within its own facility by making available a minimum
amount of information regarding the container's history.
The records in Sec. 165.136(b) would have to be kept only for those
containers that the refiller is going to refill; i.e., only those
containers delivered to the refiller to be refilled. A refiller would
not have to keep records for those refillable containers that the
refiller returns to a registrant. In other words, this section would
not establish a nationwide container tracking system.
A log that includes the specified information would be sufficient
to satisfy the requirements of proposed Sec. 165.136(b).
Section 165.136(c) specifies the information a refiller would have
to record and maintain each time a product is repackaged into a
refillable container for sale or distribution. One record would be
required for each container for each instance of filling or refilling.
The records specified in proposed Sec. 165.136(c) generally are
intended to verify that the refiller is complying with the Sec. 165.134
requirements regarding containers, including repackaging, inspection,
and residue removal.
The first three pieces of information specified in proposed
Sec. 165.136(c) would identify the specific sale or distribution of a
pesticide product. These records would include: (1) The name, EPA
registration number, and amount of the pesticide product distributed or
sold in the refillable container, (2) the date of the distribution or
sale, and (3) the name and address of the consignee. Section
165.136(c)(4) would require a refiller to record the serial number of
the container, which would link the specific pesticide formulation to a
specific container.
The connection between the specific product and the container in
which it is sold or distributed is important in several ways. The
records in proposed Sec. 165.136(c) would help substantiate that the
refiller took proper steps in refilling containers. While the refiller
would be required by proposed Sec. 165.134(i) to place its EPA
establishment number on the label, the Sec. 165.136(c) records would
provide a connection between the container, the product, and the
refiller, in case the refiller did not put its EPA establishment number
on the label or if the label fell off the container.
In addition, the information required in Sec. 165.136(c)(1) through
(c)(4) would allow an inspector to spot check whether the refiller is
repackaging product only into refillable containers identified on the
list of acceptable containers provided by the registrant, as required
by proposed Sec. 165.134(c)(1)(i). An inspector could compare the
refillable container (which would be permanently marked with the serial
number and the model number) at the refiller's facility with the
Sec. 165.136(c) records and the registrant's list of acceptable
containers to determine compliance or noncompliance with proposed
Sec. 165.134(c)(1)(i).
Refillers may already be required to keep some of the information
specified in Sec. 165.136(c) -- the identity and amount of the
pesticide product, the date of distribution or sale and the identity of
the consignee -- under 40 CFR part 169 or 40 CFR part 171. Section
169.2(d) requires that this information be kept for the shipment of all
pesticides, devices, and active ingredients used in producing
pesticides; and, in states where EPA administers the certification
plan, Sec. 171.11(g) requires restricted use pesticide dealers to
maintain this information, for each transaction involving a restricted
use pesticide.
In general, a log that includes the specified information would be
sufficient to satisfy the requirements of proposed Sec. 165.136(c).
As specified in Sec. 165.136(c)(5), a refiller would be required to
record that the container inspection procedure was conducted and the
results of the inspection, which would indicate compliance with
Sec. 165.134(e).
Refillers would be required under Sec. 165.136(c)(6) to record
whether a refilling residue removal procedure was conducted and if not,
the reasons why the container was not cleaned. This information, in
addition to the records specified in Sec. Sec. 165.136(b) and
165.136(c)(1) through (c)(4), could be used to indicate whether the
refiller cleans containers when necessary, as specified in
Sec. 165.134(g).
In addition, the information specified above -- whether a refilling
residue removal procedure was conducted, the container identification,
the previous product identification, and the repackaged product
identification -- is important in case the product in the container is
determined to be contaminated. This information could aid in
determining who is responsible for contaminated product and how the
product got contaminated.
15. Compliance date. In section 19(e) of FIFRA, Congress directed
EPA to promulgate container design regulations by December 24, 1991 and
required compliance with these regulations by December 24, 1993. For
the reasons set out in Unit IV.B.9 of this preamble for proposed
subpart F, Sec. 165.139(a) would provide a period of 2 years after the
date of publication of the final rule in the Federal Register before
compliance with subpart G would be required. This would apply to both
the container design and the refilling requirements. In other words,
within 2 years of the publication date of the final rule, pesticides
could only be distributed or sold in containers that meet the
requirements of subpart G. Also, within 2 years of the publication
date, registrants and refillers would have to meet the refilling and
recordkeeping requirements of subpart G. The Bulk Pesticides
Enforcement Policy will be in effect until the compliance date; i.e., 2
years after the final rule promulgating subpart G is published in the
Federal Register.
Proposed Sec. 165.139(b) would specify that certifications for
pesticide products registered as of the publication date of the final
rule would be required to be submitted to and received by EPA within 2
years of the date subpart G is published as a final rule.
EPA believes that a 2-year implementation period would provide
enough time to comply with the procedural requirements of subpart G
including the exchange of information between the registrant and the
refiller.
Container and equipment (e.g., pump and meter) manufacturers have
indicated that it takes about a year for the designing and testing that
is necessary to go from a set of specifications to a final product.
Therefore, EPA does not anticipate a problem with the availability of
acceptable containers and appurtenances.
Additionally, EPA believes that many containers currently being
used meet the proposed requirements, with the possible exception of
some of the proposed permanent marking. EPA believes that existing
containers that meet most of the standards (such as the drop test) can
be retrofitted; e.g., permanently marked with information such as a
serial number.
EPA is concerned that there may be containers that could not be
used after the 2-year phase-in period, although the containers may be
structurally sound. For example, a sound minibulk container may not be
permanently marked with the phrase ``Meets EPA standards for refillable
pesticide containers'' and, for some reason, may not be able to be
retrofitted. EPA is aware that prohibiting the use of containers such
as these may create a disposal problem and cause a financial burden to
the owners of these containers.
One option EPA considered was a ``grandfather'' provision, which
would allow existing containers to be used for a specified period of
time, such as 5 years. However, the proposed regulatory scheme clearly
makes registrants responsible for the containers in terms of both
meeting the proposed standards of Sec. 165.124 and ensuring
compatibility with the pesticide formulation. Extending an automatic
regulatory exemption for existing refillable containers could allow a
refiller to repackage a product into a container other than a container
on the registrant's list of acceptable containers, if the registrant
allowed its product to be distributed or sold in such containers.
Therefore, EPA rejected the option of a grandfathering provision for
all refillable containers because of the potential problems with
incompatibility and substandard containers, as well as the possible
confusion caused by inconsistency between the regulations and the
registrant's list of acceptable containers.
EPA also considered an option where registrants could
``grandfather'' existing containers that met minimum standards. Under
this option, EPA would allow registrants, under certain conditions, to
have containers on their list of acceptable containers that don't meet
all of the standards in Sec. 165.124. Some conditions that EPA might
consider appropriate include: (1) The container is currently in use in
the field, i.e., it is an ``existing'' container, (2) EPA approves a
date suggested by the registrant, such as 5 years after the date the
regulations are published, after which the container cannot be used.
(Plastic minibulk containers could not be used after they are more than
6 years old), and (3) the container meets a set of standards, that
would have to be approved by EPA. While this option would provide a
registrant some flexibility, it could still cause confusion for
refillers who are trying to comply with the regulations. For example,
if an existing container without a serial number was allowed to be
used, the refiller could not comply with the recordkeeping
requirements. In addition, this option could impose a considerable
burden on EPA resources for administering an approval program for each
registrant.
EPA requests comment on whether a 2-year phase-in period for
compliance with subpart G is appropriate or whether an alternative,
such as the option described above, should be incorporated into the
final rule. EPA requests commenters to be as specific as possible about
suggesting alternatives, including information on the number of
existing containers that might need to be grandfathered, suggestions
for the standards that might be appropriate for the grandfathered
containers, and the potential confusion and conflicts the use of the
grandfathered containers might have on other parts of the regulations
and the regulated community.
VI. Standards for Pesticide Containment Structures
A. Background
1. Introduction. Subpart G of this proposed rule introduces
container design and residue removal standards for pesticide refillable
containers, including liquid bulk containers and dry bulk containers.
In subpart H, EPA proposes standards for containment structures to
intercept and contain spills and leaks from stationary bulk containers,
areas where pesticides are dispensed from and into stationary bulk
containers, and areas where containers are refilled. These containment
standards would apply to facilities of agricultural pesticide refilling
establishments and custom blenders (as defined in Sec. 167.3), and to
facilities of businesses that apply agricultural pesticides for
compensation (also referred to as for-hire applicators in this
preamble).
The proposed requirements include criteria for design, maintenance,
and operation of containment structures. They are intended to introduce
basic safeguards in States that currently lack containment regulations
and to harmonize with containment requirements in States where adequate
containment safety programs already exist. EPA believes that the
proposed Federal containment standards, together with proposed
requirements for container design and residue removal, are essential
for ensuring the safe use, reuse, and refill of containers as required
by FIFRA section 19.
These proposed standards are intended to prevent pesticide
contamination of soil and water resources at pesticide bulk container
storage facilities and at facilities where container refilling
operations occur. Although spills can occur throughout the chain of
pesticide commerce (from manufacturer to user), the accumulated
evidence points to agrichemical dealerships, custom blenders, and for-
hire applicators as facilities where pesticide contamination of ground
and water is most frequently documented. Bulk pesticide containers are
located at many of these facilities, and agrichemical dealerships often
serve as refilling establishments for refillable agricultural pesticide
containers. Failure of stationary bulk containers at such facilities
can result in significant environmental contamination, but so too, can
failures of hoses and pipes (appurtenances), operational errors (e.g.,
overfilling), improper containment systems, improper disposal of
pesticide rinsates, and vandalism. These findings lead EPA to conclude
that unless storage of bulk containers and refilling operations are
addressed as integrated systems, the FIFRA section 19 mandate for
regulations that ensure safe reuse and refill of pesticide containers
cannot be satisfied.
These proposed standards are designed to supplement the proposed
subpart G standards addressing design, structural, and residue removal
standards for refillable containers. EPA believes that additional
standards are necessary for containment structures because the safety
of use, reuse, and refill depends on a number of factors that affect
the refilling activity, particularly in situations where pesticides are
stored in large refillable containers and where refilling operations
routinely occur.
The remainder of Unit VI.A of this preamble describes pesticide
bulk container storage facilities and refilling operations and
characterizes their sources of pesticide leaks and spills. The nature
of environmental problems for such operations is also discussed, as are
efforts by States to prevent further environmental problems.
2. Pesticide bulk containers and refilling operations: sources of
leaks and spills. Bulk containers are used at many levels in the
pesticide distribution network -- from registrants, formulators,
distributor tank farms, and dealerships to for-hire and private
applicators. The categories of bulk pesticide container facilities for
which EPA has accumulated the most substantial evidence of soil and
ground-water contamination, and thus the focal point of the proposed
containment regulations, are the facilities of refilling establishments
and for-hire applicators of agricultural pesticides. Facilities where
agricultural pesticides are custom blended from bulk containers are
also proposed for regulation. Typically, bulk containers for
agricultural pesticide refilling establishments, for-hire application
services, and custom blending operations are maintained at the
facilities of agrichemical dealerships. However, bulk containers are
also used at the facilities of independent for-hire applicators and may
also be used at the facilities of independent custom blenders, though
EPA believes that independent custom blenders are likely to be rare.
Refilling establishments whose principal business is retail, custom
blenders and for-hire applicators of agricultural pesticides (referred
to collectively as ``commercial agrichemical facilities'' in this
preamble) may use pesticide bulk containers for many purposes. For
example, they may refill minibulk pesticide containers for sale and
distribution or for use as shuttles to transport pesticides from the
dealership to the field for their for-hire application services. They
may also use bulk containers to supply pesticides to custom blending
services where pesticide is mixed with material such as fertilizer,
another pesticide, or seed on a customer-order basis. Commercial
agrichemical facilities may also use bulk containers to store
fertilizers, but unless such fertilizers are mixed with and therefore
labeled as pesticides, they are not subject to FIFRA.
Pesticide bulk containers at these facilities usually hold
herbicides. Liquid bulk containers typically range in capacity from
1,000 to 5,000 gallons, though some dealers may have containers with a
capacity of 30,000 or more gallons. Dry bulk containers that hold as
much as 90,000 pounds can be found at dealerships.
At commercial agrichemical facilities, pesticides generally are
transferred to and from bulk containers via appurtenances (pipes,
hoses, pumps, and/or meters) that terminate at a dispensing area. This
dispensing area may serve as a site to clean or refill containers,
nurse tanks, or application equipment, and it may also be used to
transfer pesticides from delivery vehicles into bulk containers. In
some cases, pesticide rinsates resulting from cleaning operations are
collected and stored in bulk containers. Depending on State and local
regulations and registrant requirements, bulk containers and dispensing
areas may or may not be located inside a protective containment
structure.
A number of potential sources of pesticide spills exist at
refilling operational sites and facilities that store or dispense
pesticides from bulk containers. Available information suggests that
chronic small leaks from containers and appurtenances or recurrent
improper pesticide waste disposal are responsible for environmental
contamination in many cases (see later discussion). Larger, sudden
releases of concentrated product probably occur less frequently, but
perhaps due to their more dramatic nature and to existing release
reporting requirements such as CERCLA section 403 and EPCRA section
304, their occurrence is better documented than chronic spills. Causes
for such major spills include: (1) Bulk container failure (due to
structural defects, corrosion of the containers by incompatible
pesticides, improper installation, fire, collisions with equipment,
etc.), (2) failure of pipes, hoses, valves, or pumps, (3) operator
errors (e.g., neglecting to shut off valves, overfilling, leaving
transfer operations unattended), and (4) vandalism.
Insight into the causes of these mishaps can be gained from Federal
and State spill incident reports and from comments by industry. The
National Response Center (NRC, administered by the U.S. Coast Guard)
provides a Federal mechanism to receive and refer for action and/or
investigation reports of oil, chemical, biological, and etiological
releases into the environment in the United States and its territories.
Some incidents involving releases of certain hazardous substances or
materials listed under several statutes, including the Comprehensive
Environmental Response, Compensation, and Liability Act, secs. 101(14)
and 102 (42 U.S.C. 9602) and the Transportation Safety Act of 1974 (49
U.S.C. 1802 and 1803), are required to be reported to the NRC. These
statutes, however, include only some pesticides on their list of
hazardous substances or materials. Although only a portion of the
incidents involving pesticides are reportable, the NRC database does
include a number of incidents in which significant quantities of
pesticides were released.
In analyzing incident data provided by the NRC for a reporting
period of 1982 through May 1991, EPA identified 40 incidents in which
spills appeared to be associated with bulk pesticide containers (Ref.
60). Transportation incidents, other than those involving mishaps
during transfers into or from delivery vehicles, were excluded from
this analysis. Seventy percent of the spills (28 of 40) involved
herbicides. The reported quantities of pesticide released ranged from 2
gallons to an estimated 1,000 gallons. The most frequently listed
causes of spills, in descending order, were:
(1) Transfer mishaps (hoses or couplings failing or dislodging
during load-in or load-out, etc.) (38 percent).
(2) Appurtenance failure (leaks or breaks in pipes or valves,
valves left open, sight gauge failure, etc.) (30 percent).
(3) Container failure (corroded, collapsed) (12 percent).
(4) Overfilling (13 percent).
(5) Vandalism (5 percent).
(6) Unspecified (2 percent).
The Nebraska Department of Environmental Control also maintains a
spill incident database that includes reports of pesticide spills.
During a 10-year reporting period (May 1981 through March 1991), 20
incidents were reported that appeared to involve bulk pesticide
operations. The quantities of pesticides reported spilled (all
herbicides) ranged from a few gallons to 1,400 gallons. Failure of
appurtenances was the most commonly encountered cause of discharge (six
cases; 30 percent). Vandals were reported responsible for spillage in
four incidents and operator errors (e.g., overfilling containers and
allowing hoses to become dislodged during transfers) caused four
incidents. Container failures (e.g., container tipped over and burst)
accounted for three other spills. The causes of incidents were not
reported in three cases (Ref. 34).
In documenting the need for containment regulations for large
pesticide containers, the Wisconsin Department of Agriculture, Trade
and Consumer Protection (WDATCP) cited nine pesticide spills that
occurred from 1981 to mid-1984. Volumes released ranged from a few
gallons to 1,700 gallons. Causes included four transfer mishaps (hose
and valve failure), four container-related incidents (valve failure,
container rupture, overflow from rain into an open container) and one
fire (Ref. 78).
Subsequently, the WDATCP noted several additional bulk-related
spills of herbicides, including (Ref. 42):
(1) A 4,600-gallon spill when ice sheared off a container valve.
(2) A 550-gallon loss when a hose outside of containment ruptured.
(3) A 3,000-gallon release into a warehouse (cause not specified).
(4) A 40-gallon spill due to a plumbing failure (containment
allowed recovery and use of the herbicide).
The WDATCP also indicated that installation of containment
structures enabled many commercial operations to detect small spills
that previously eluded notice (Ref. 42).
Some pesticide registrants whose agricultural pesticides are sold
and distributed from bulk containers at refilling establishments cite
appurtenance failure as a leading cause of leaks and spills. Other
common causes they identify are hoses/couplings dislodging during load-
out, human error (e.g., leaving valves open on unattended equipment),
and overfilling. Pinhole leaks in bulk containers, sight gauge failure,
vandalism, and fire also have been noted as sources of spills. Spills
from bulk containers or appurtenances that were reported to companies
range from 1 gallon to 5,000 gallons, but quantities of several hundred
gallons are typical (Ref. 66).
The above information from Federal, State and industry sources
consistently indicates that in addition to container failures, leading
causes of sudden spills at bulk pesticide storage and dispensing
operations are failures of appurtenances and/or human errors during
pesticide transfers, vandalism, and fire. In addition to these larger
and more noticeable spills, small chronic leaks of pesticide
concentrate and improper management of pesticide rinsates also can
occur and contribute to environmental contamination. These findings
underscore that regulations promoting safe container reuse and refill
should address not only the structural integrity of bulk containers,
but also should include safeguards for appurtenances, dispensing
operations, and container refilling operations.
3. Frequency of leaks and spills. Although several databases on
chemical spill incidents are available, none provides a comprehensive
outlook on pesticide-related incidents. As mentioned previously, a
Federal reporting mechanism is in place at the National Response
Center, but as this applies only to releases of specified substances
above a threshold quantity, many incidents involving pesticides could
be exempt from reporting. Chronic small spills may go unnoticed and
uncontrolled discharges of dilute pesticide rinsates may not be
recognized as a significant source of environmental contamination by
facility owners and operators. Reluctance of operators to bring spills
to the attention of environmental or other authorities also may lead to
under-reporting.
Despite reporting limitations, EPA has obtained independent rough
estimates of the frequency with which spills are noted at facilities
that store pesticides in bulk containers or conduct loading/refilling
operations. These estimates pertain only to spill incidents that were
clearly noticeable, i.e., relatively large quantities of pesticides
were involved; many of the cases were reported as a result of
complaints. They were not derived from environmental sampling surveys
of facilities for pesticide contamination.
The Michigan Department of Agriculture has compiled a summary of
agriculture-related pollution emergency incidents (such as reported
spills of agrichemicals and improper disposal of farm wastes, including
pesticide rinsates) from 1987 through early 1991. Based on reports of
180 incidents, EPA estimates that about 1 of every 75 Michigan
pesticide dealers (1.3 percent) experiences a reported release each
year (Ref. 68).
The Nebraska Department of Environmental Control requires the
reporting of spills of threshold quantities of CERCLA hazardous
substances, as well as spills of 10 pounds or more of pesticide active
ingredients. Based on Nebraska's 1984 through 1990 data, calculations
suggest that noticeable leaks occur annually at nearly 1 percent of the
State's 350 bulk storage and refilling establishments (Refs. 34 and
68).
The Michigan and Nebraska figures agree with those offered by some
registrants, who estimate that 1 percent to 1.5 percent of agricultural
pesticide bulk storage sites report spill incidents each year (Refs. 66
and 68).
4. Soil and ground-water contamination. Many States have documented
soil and ground-water contamination problems resulting from pesticide
spills at commercial agrichemical facilities that engage in pesticide
storage and transfer operations. Two of the most comprehensive reports
to date on this subject were jointly authored by the Wisconsin
Department of Agriculture, Trade and Consumer Protection and the
Wisconsin Department of Natural Resources. Their 1989 study (Ref. 20)
of 20 for-hire agricultural pesticide applicator facilities was
prompted by the detection of pesticide residues in private wells at or
near 18 facilities and by reports of pesticide spills at two other such
facilities. Fourteen of the sites studied were facilities that handled
liquid pesticides in containers larger than 55 gallons. The survey
revealed that pesticide contamination of soil was commonplace at these
facilities. The greatest total concentrations of pesticides occurred at
acute spill areas (where relatively large accidental spills had
occurred), areas where containers were burned, mixing and loading
sites, and pesticide storage areas. Soil sampling data obtained after
implementation of soil remediation actions at these sites showed that
chronic spillage continued to be a problem and even increased in
several cases, because the users continued to engage in improper
disposal practices (Refs. 20 and 80).
Pesticide residues were detected in drainage-ways and temporary
ponds adjacent to pesticide handling areas. The residues subsequently
may have dispersed into ground water through leaching and via movement
of surface waters: pesticide residues were reported in ground water at
concentrations that often exceeded Wisconsin health advisory levels. In
four cases, ground water up-gradient from the facility also contained
pesticide residues, suggesting additional sources of contamination
(Ref. 20). The report concluded that the most effective approach toward
preventing further environmental problems would be to develop long-
range management practices and install proper secondary containment for
bulk containers and containment pads for pesticide transfer operations
(Ref. 20).
In 1991, the same Wisconsin agencies reported the results of an
environmental survey of 27 randomly selected agricultural pesticide
application business sites (Ref. 45). (This study was designed to
assess operations representing the industry as a whole.) The
investigation revealed the presence of pesticides in soil at 25 of the
27 locations. Soil at 18 (66 percent) of the sites may eventually
require remediation; these sites had pesticide concentrations exceeding
those that would have been expected had pesticide been applied at
labeled field rates. Pesticides also were found in ground water at more
than half (55 percent) of the sites. At nine of these locations (33
percent of total sites) pesticide levels exceeded Wisconsin ground-
water standards.
Given these results, the Wisconsin agencies estimate that between
45 percent and 75 percent of the State's commercial agrichemical sites
may require soil remediation and that 29 percent to 63 percent
potentially exceed the State's ground-water standards for pesticides.
Many of the latter also may require remediation (Ref. 45).
A study of commercial agrichemical facilities in Utah found
pesticide contamination resulting from a variety of handling activities
such as spills of pesticide in bulk container storage and dispensing
operations, mixing and loading into application equipment (for
facilities that engaged in for-hire application), and equipment
cleaning activities. Residues were detected in pesticide handling areas
and adjacent areas to which they drained, as well as in gravel
driveways and parking lots (Ref. 47).
Much of the contamination found in the Utah study appeared to be
associated with spills of custom blended pesticide/fertilizer mixtures.
Pesticide-impregnated fertilizer loading areas have been identified by
the National AgriChemical Retailers Association as being associated
with elevated concentrations of pesticide contamination (Ref. 46).
Case studies of Iowa commercial agrichemical facilities revealed
pesticide levels approximating formulation concentrations in pools of
water and soil in areas where pesticides were loaded and handled or
where containers and equipment were rinsed (Ref. 21). The Iowa
Fertilizer and Chemical Association estimates that 40 percent to 50
percent of the sites in Iowa may require remediation for existing or
potential ground-water contamination (Ref. 15). In Kansas, 70 percent
to 80 percent of the detections of pesticide in ground water could be
traced back to pesticide dealerships (Ref. 46). Minnesota identified
ground-water contamination in 20 of 100 active spill incident cases at
commercial agrichemical facilities in 1991 (Ref. 41).
Between 1984 and 1989, complaint-generated investigations in
Illinois confirmed several incidents of pesticide contamination of
private well water. Thirteen of these instances were attributed to the
handling of pesticides at agricultural pesticide retail facilities.
Likely causes of this contamination included pesticide runoff and
waste-water discharges into surrounding areas, and chemical spills
resulting primarily from leaking storage containers and handling
mishaps (Ref. 57). In 1987 and 1988, the Illinois Department of Public
Health surveyed wells at 81 commercial agrichemical facilities
(randomly selected from a statewide pool of over 1,500 licensed
facilities). The survey detected pesticides in 65 percent of these
sites, with multiple pesticide residues detected in many of the wells
(Ref. 33). By contrast, various public water supply monitoring projects
conducted by the Illinois Environmental Protection Agency (IEPA)
typically reveal pesticides in only about 1 percent of samples (Ref.
19).
A recent joint study by the Illinois Department of Agriculture and
the Illinois State Geological Survey (Ref. 26) revealed that soils from
all of 49 randomly selected agrichemical facilities contained
pesticides at levels that exceeded draft IEPA site-specific soil
cleanup objectives. One or more pesticide residues also were detected
in 25 percent of the 52 water-supply wells sampled at the sites,
however, concentrations of pesticides in water samples generally were
less than those encountered in the 1987-1988 Illinois Department of
Public Health survey (Ref. 33). These recent findings led the authors
of the joint report (Ref. 26) to suggest that although ground water
below many currently active agrichemical facilities does not appear to
have been extensively impacted by past facility practices, concern for
ground water is warranted.
Other studies point to pesticide contamination of public or private
drinking water wells located near commercial agrichemical facilities.
For example, Hallberg (Ref. 22) cites 10 Iowa case studies in which
pesticide concentrations in ground water near dealerships were a
hundredfold or more concentrated than background levels. In more than
80 percent of the instances in which herbicides other than atrazine
have been detected in Iowa's public wells, the wells were located near
commercial agrichemical facilities (Ref. 13).
In a 1989 survey, the Michigan Department of Agriculture sampled
well water from 50 commercial agrichemical bulk storage sites.
Pesticides were detected and confirmed in well water from eight (16
percent) of the sites; health advisory levels for pesticides were
exceeded in three of the wells. Pesticide concentrations in soils were
not determined. The report concluded that commercial agrichemical bulk
storage operations located on hydrogeologically vulnerable sites pose a
threat to ground-water quality (Ref. 36).
Other types of users/operations with practices similar to
commercial agrichemical facilities may cause environmental
contamination, but for these there is less evidence available. A survey
conducted by the Association of American Pesticide Control Officials
(Ref. 2) responded to by 28 States revealed 826 commercial agrichemical
facilities with documented environmental degradation, but also 121
private sites. Of the 121 private sites, 32 were associated with
agricultural research sites. In water quality surveys of farm wells,
detections of the highest levels of pesticides sometimes have been
attributed to factors such as improper pesticide storage or handling
near the well (Refs. 9, 27, and 54).
5. Contamination remediation costs. Remediation of contamination
resulting from inadequate pesticide containment and poor waste
management practices can be very costly. For example, one registrant
spent $207,714, $51,300 and $184,440 for clean up of three separate
spills from bulk containers between 1981 and 1983 (Ref. 50). While most
States have not begun to assess systematically the degree to which
commercial agrichemical facilities require remediation, information
from midwestern States indicates a substantial problem. Based on
results of samples taken from 50 sites and on files of other open
cases, the Minnesota Department of Agriculture estimates that virtually
all of the 1,000 commercial agrichemical facilities active in the State
will need to conduct contamination assessments and that some degree of
remediation will be required for at least half of the sites. Cost
estimates derived from the Department's experience with approximately
100 cases suggest that 50 percent to 60 percent of the contaminated
sites will be remediated for at least $20,000 to $50,000, not including
certain costs (such as attorney fees); 20 percent for $50,000 to
$200,000; and 20 percent for more than $200,000, with costs
occasionally exceeding $1 million (Ref. 6).
The Illinois Environmental Protection Agency notes that while
conclusive data do not yet exist, some two-thirds of the State's 1,500
commercial agrichemical sites eventually could be found to warrant some
degree of remediation for contamination ``hot spots.'' Typical costs
for assessment and remediation for such facilities would average
between $15,000 and $50,000. Another 15 percent of the facilities are
projected to require more extensive cleanup (cost range $50,000 to
$250,000); 2 percent to 5 percent more could require even more
expensive remediation (Ref. 56). A recent Illinois study of site
contamination at agrichemical facilities (Ref. 26) estimates that
statewide costs for soil remediation will range from $8 million to $96
million, with the most realistic estimate thought to be $42 million.
These estimates do not include costs for site assessments or for
remediation of contaminated ground water.
A study conducted by the WDATCP indicates that 45 percent to 75
percent of Wisconsin's commercial agrichemical facilities are likely to
require soil remediation. Many also may need to remediate ground-water
contamination (Ref. 45). Typical costs for soil remediation range from
$10,000 to $50,000. If ground-water contamination is encountered,
especially if municipal water supplies are affected, the costs can be
much higher. For example, a Wisconsin agrichemical facility recently
spent $350,000 to characterize the extent of pesticide contamination in
a municipal drinking water supply and install ground-water remediation
equipment, and further significant expenses are anticipated (Ref. 43).
In Iowa, where roughly half of the commercial agrichemical
facilities will require remediation, direct costs for site assessments,
monitoring, and remediation of pesticide dealerships could reach $50
million to $100 million (Ref. 15).
6. State bulk containment regulations. As of December 1992, 27
States had implemented or were drafting containment regulations for
pesticides (Ref. 71). In the State of the States Report (Ref. 70), EPA
learned that pesticide containment regulations vary considerably among
the States. Requirements range from relatively minimal standards to
comprehensive rules governing construction of bulk containers,
secondary containment for storage containers, containment pads for
various operations (such as refilling, mixing and loading, washing,
rinsing), spill response, recordkeeping, and rinsate and precipitation
accumulation management. Some States also include standards for
facility location and abandonment and requirements to notify the State
of various activities. Some critical areas in which State pesticide
containment regulations (implemented or draft) differ include (Ref.
70):
a. Applicability of regulations to persons, quantities, and
identities of materials. State bulk regulations vary with respect to
facilities/operators to whom containment requirements apply. Rules may
pertain to manufacturers, distributors, or users of pesticides or may
apply more specifically, such as to repackagers, dealers, commercial
applicators, and/or farmers.
Some States apply secondary containment requirements to any
pesticide container with a volume exceeding 55 gallons; others use 210-
, 300- or 500-gallon criteria. Containment rules may apply to technical
grade, formulation grade, or similar grade pesticides or may extend to
rinsates and use solutions.
b. Capacity of secondary containment for bulk containers. States
commonly set the minimum holding capacity of secondary containment
structures according to the volume of the largest container within the
structure plus a margin for safety. The safety margin generally
requires compensation for volume displaced by containers and equipment
and requires additional capacity for structures exposed to
precipitation. Some variations among States in safety margin include
(separately or in combinations):
(1) Ten percent of the volume of the largest container.
(2) Twenty five percent of the volume of the largest container.
(3) The volume of rainfall from a 25-year, 24-hour storm.
(4) Six inches of freeboard.
c. Materials for secondary containment. Most States allow concrete,
steel, or solid masonry, provided the material is impermeable to
pesticide. Several permit soil containment. Others allow various
synthetic materials, if they are compatible with pesticides.
d. Specifications for containment pad. States typically require
paved, curbed and/or sloped containment for pesticide handling
operations. Most specify construction with concrete, although some
allow asphalt.
e. Permitting and notification. Several States require permits
prior to construction or, for existing facilities, procedures and
permits must be followed to phase facilities into compliance with new
regulations. Several also require notification to the State annually
prior to initial delivery.
In summary, most States do not currently have pesticide containment
regulations. Some States are delaying development of containment rules
until Federal standards appear. Among the States that have rules, there
exists considerable variation in the scope and stringency of
requirements. The Federal containment requirements proposed today would
establish basic standards which are generally similar to State
standards, although they may be more rigorous than some and less
stringent than others. These Federal standards would not preclude
States from adopting more rigorous State requirements.
7. Conclusions. There is considerable evidence that the routine
storage and dispensing of large quantities of pesticides at commercial
agrichemical facilities is associated with significant environmental
contamination by pesticides. Although it is not always possible to
relate specific incidents of contamination at such facilities to
particular activities, it is clear that improvements in containment and
related management practices for pesticide bulk storage and container
refilling operations can help prevent environmental contamination.
As discussed further in Unit VI.B.1 of this preamble, EPA proposes
to require containment structures at refilling establishments, custom
blenders, and for-hire applicators where agricultural pesticides are
stored and dispensed. Containment requirements for bulk container
storage and container refilling operations, in conjunction with
container design standards and adequate procedures for residue removal,
would provide an integrated system of environmental safeguards. Each of
these three regulatory components is considered essential to ensure the
safe refill and reuse of pesticide containers.
B. Today's Proposal
Subpart H of the proposed regulations is organized into three
general categories: general standards for containment structures,
secondary containment for bulk containers, and containment for
pesticide dispensing areas (where the contents of bulk containers are
dispensed and/or containers are refilled). Performance standards for
containment materials and design are proposed, as are requirements for
operation, maintenance, and recordkeeping. Certain containment
requirements for facilities with existing structures are proposed as
interim standards to allow sufficient time for retrofitting and to
provide a phased approach to meeting new requirements.
The definition section of proposed subpart A of this proposed rule
contains definitions of terms used in proposed subpart H and related
subparts. Terms that are key to the understanding of subpart H include:
(1) Agricultural pesticide.
(2) Appurtenances.
(3) Container.
(4) Containment pad.
(5) Containment structure.
(6) Dry bulk container.
(7) Dry pesticide.
(8) Liquid bulk container.
(9) Pesticide dispensing area.
(10) Owner.
(11) Operator.
(12) Refillable container.
(13) Refilling establishment.
(14) Secondary containment unit.
(15) Stationary bulk container.
(16) Transport vehicle.
(17) 25-year, 24-hour rainfall event.
1. Scope and applicability. Section 165.140 sets out the scope and
purpose of subpart H. The regulations would establish requirements for
containment of stationary bulk containers and requirements for
containment of pesticide dispensing areas. These requirements are
intended for two purposes: to protect human health and the environment
from exposure to pesticides from spills and leaks, and to reduce wastes
produced when pesticides are stored and handled in bulk containers and
during container refilling operations.
Descriptions of the applicability of subpart H would appear in two
tiers in Secs. 165.141 and 165.142. Section 165.141 identifies
facilities and persons that would be responsible for meeting the
requirements of subpart H. For those facilities included, Sec. 165.142
would then delineate the universe of stationary bulk containers and
pesticide dispensing areas to which the containment requirements apply.
a. Facilities and persons covered. Section 165.141 would apply the
requirements of subpart H to the following three types of facilities
that contain a stationary bulk container or a pesticide dispensing area
for an agricultural pesticide (as defined in subpart A): (1) Pesticide
refilling establishments (as defined in subpart A) whose principal
business is retail sale, (2) custom blenders as defined in 40 CFR
167.3, and (3) the facilities of businesses that apply an agricultural
pesticide for compensation (other than trading of personal services
between agricultural producers).
Facilities that refill an agricultural pesticide into refillable
containers and whose principal business is retail sale would be
encompassed whether or not they used a stationary bulk container to
supply the refilling operation. Retail-oriented establishments would be
included because EPA has obtained significant evidence of environmental
contamination from pesticide leaks and spills at such establishments
(as documented in Units VI.A.2 through VI.A.4 of this preamble). EPA
intends to defer consideration of containment requirements at refilling
establishments whose primary function is formulation or manufacturing
of pesticides, since EPA does not possess sufficient information
regarding the practices and environmental problems of these facilities.
Moreover, EPA believes that such facilities may warrant containment
requirements considerably different from those in today's proposal. If
formulation and manufacturing activities are conducted at a refilling
establishment whose principal business is retail sale, EPA intends that
containment requirements would be applicable at the facility.
Also encompassed in Sec. 165.141 would be facilities of businesses
that apply an agricultural pesticide for compensation (other than
trading of personal services between agricultural producers). This is
intended to include the facilities of those pesticide applicators who
provide a service of controlling agricultural pests, whether or not
they are part of a refilling establishment. The facilities of such for-
hire applicators may store and handle large quantities of agricultural
pesticides on a routine basis. As discussed in Unit VI.A.4 of this
preamble, there is substantial evidence of soil and ground-water
contamination by pesticides at such facilities. Among potential sources
of pesticide releases are areas where pesticides are stored and
dispensed from bulk containers into application equipment and areas
where containers are rinsed.
EPA does not intend Sec. 165.141(b)(3) to include the facilities of
farmers who apply agricultural pesticide for other farmers on a for-
hire basis when such service is a minor component of the farm's
operation and when it is conducted only on an occasional basis. EPA
does not believe that these facilities necessarily will have the same
environmental impacts as refilling establishments because their for-
hire activities constitute only a small part of the facilities'
activities. However, comments are requested to address this assumption
and to identify the number and characteristics of farm facilities that
would be affected by extending the requirements for containment of bulk
storage/dispensing areas to such for-hire farm facilities.
EPA intends that the requirements of subpart H should apply to the
facilities routinely used by for-hire applicators, but not to field
application sites, since different requirements may be appropriate in
locations that are used on a temporary basis. Pesticide transfers at
temporary sites in the field may be addressed in future rulemaking.
Section 165.141 would apply the requirements of subpart H to the
facilities of custom blenders (as defined in 40 CFR 167.3) who blend an
agricultural pesticide on a customer-order basis with materials such as
fertilizers and other pesticides. Based on the available evidence (see
Unit VI.A.4 of this preamble), EPA believes bulk pesticide storage and
dispensing in custom blending operations pose environmental risks
similar to those encountered at refilling establishments. Since most
custom blenders are thought to operate as a part of the business of
refilling establishments, containment requirements would be applicable
by the previously mentioned sections in Sec. 165.141. However, because
some custom blenders may operate independently, Sec. 165.141 also would
include a separate statement of applicability to custom blenders. (Note
that the scope of proposed subpart H differs somewhat from the scope of
proposed subpart G with respect to custom applicators and custom
blenders. Refer to Unit V.B.6 of this preamble for a discussion of this
issue).
In addition to identifying applicable facilities, Sec. 165.141
would stipulate that the owners and operators of the containment
structure are jointly responsible for assuring that the facility
complies with the requirements of subpart H. As defined in subpart A of
the proposed rule, the term ``owner'' means any person who owns a
facility at which a containment structure is required; ``operator''
means any person in control of, or having responsibility for, the daily
operation of a facility at which a containment structure is required.
The intent of Sec. 165.141 is to hold the owner and operator jointly
liable. EPA requests comments as to whether both the owner and operator
or only one of these parties should be held responsible, or whether
other parties also should be held responsible.
Although commercial agrichemical facilities represent only a subset
of the realm of facilities/operations where containment requirements
might be appropriate, EPA is not proposing at this time that
Sec. 165.141 extend the requirements of subpart H to other types of
facilities that store and dispense pesticides in bulk containers or
conduct refilling operations. EPA is giving priority to rulemaking for
commercial agrichemical facilities because these are the facilities for
which the clearest pattern of soil and ground-water contamination by
pesticides has been established. However, because EPA intends to
consider further containment-related rulemaking for other elements of
the pesticide industry, commenters are invited to address relevant
problem areas encountered industry-wide.
Specifically, some form of containment provisions may be
appropriate for bulk storage facilities of registrants and
distributors. These operations generally maintain and handle very large
stocks of pesticides year-round; thus, EPA believes requirements
different from those proposed today may be appropriate. Specific
comments are requested that will assist EPA in characterizing the
scope, operating practices, environmental risks, and structural and
operational safeguards appropriate for these establishments.
EPA believes that containment requirements also may be necessary
for pesticide bulk containers and certain dispensing operations at the
user level. EPA believes that if bulk-related spillage occurs
frequently at commercial agrichemical facilities, it probably also
occurs at least as frequently at farm sites where pesticides are stored
and dispensed from bulk containers. EPA assumes that pesticide storage
and dispensing activities can be similar whether conducted at the
facilities of a for-hire applicator or the facilities of a large farm.
In addition, it is assumed that commercial facilities generally are
subject to more frequent inspections by regulatory authorities and that
refilling establishments are more likely to receive registrant guidance
on containment than are farm facilities. Therefore, EPA is strongly
considering expanding the applicability of Sec. 165.141 of the rule to
include agricultural users with bulk pesticide containers. EPA requests
comments specifically on whether it would be reasonable to so broaden
the final rule.
EPA also requests specific comments regarding whether Sec. 165.140
and Sec. 165.141 should be extended to apply containment requirements
to facilities where non-agricultural pesticides are stored or dispensed
from bulk containers. EPA believes that some facilities that handle
non-agricultural bulk pesticide containers (e.g., roadside weed control
operations, mosquito control operations) are sufficiently similar to
agricultural commercial facilities to cause similar environmental
problems. To determine whether it would be appropriate to extend the
proposed requirements to such facilities, EPA requests comments and
data on the scope of such establishments, their practices, state of
containment structures, and evidence of spillage or environmental
damage. EPA also requests similar information on the wood preservative
industry, structural pest control operations, and other institutional
and industrial pesticide operations for which containment provisions
may be appropriate. EPA does not intend to subject facilities to dual
regulation, and in cases where facilities are regulated under other
Federal statutes (e.g., regulation of wood preserving facility drip
pads under RCRA), comments are requested on how or whether existing
requirements could be supplemented. However, EPA notes that some
pesticides, if discarded, would be listed or characteristic wastes,
regulated under Subtitle C of RCRA. In such cases, RCRA requirements
would continue to apply.
EPA assumes that many of the facilities covered in Sec. 165.141
will also store and dispense fertilizers in large quantities. Unless
fertilizers are mixed with pesticides and therefore labeled as such,
they are not subject to FIFRA nor would they be directly subject to the
proposed regulations. However, EPA is aware that a number of States
have proposed or implemented containment regulations to protect against
uncontrolled releases of fertilizers to the environment. While the
requirements proposed today have been developed for containment of
pesticides and not fertilizers, they may contain some elements that
would be of use to States or other entities that are interested in
fertilizer containment or spill prevention measures.
b. Stationary bulk containers covered. Section 165.142 identifies
the types of stationary bulk containers and pesticide dispensing areas
to which the requirements of subpart H would apply. Section 165.142(a)
would apply secondary containment requirements to stationary liquid and
dry bulk containers at facilities encompassed in Sec. 165.141. Two key
characteristics of stationary bulk containers (as defined in subpart A)
are their holding capacity and the duration of time for which they
remain at a facility. EPA would define a liquid bulk container or a dry
bulk container by the respective volume or weight of pesticide that it
is rated to hold. Bulk containers for liquid pesticides would be
refillable containers designed to hold liquid pesticide in undivided
quantities of greater than 3,000 liters (793 gallons); bulk containers
for dry pesticides would have a capacity of greater than 2,000
kilograms (4,409 pounds). Containers of less than these volume/weight
capacities would not be required to be protected with a secondary
containment unit. The definition would include any bulk containers,
including transport vehicles, that are fixed or remain at a facility
for at least 14 consecutive days.
Thus, Sec. 165.142 applies requirements for secondary containment
to large, stationary pesticide containers. The capacities for liquid
and dry bulk containers are proposed as criteria to trigger secondary
containment requirements on the premise that container design
requirements, as proposed in subpart G of this notice, will help assure
that smaller containers do not cause a significant problem in the event
they are used for stationary storage. (See discussion of pesticide
dispensing operations below for situations in which containment would
also be required for smaller containers).
The container capacities for bulk containers are substantially
greater than volume criteria adopted by States with containment
regulations. The States use ``bulk'' criteria ranging from 55 to 500
gallons to trigger secondary containment requirements for liquid
pesticides. For dry pesticides, a typical containment trigger is 300
pounds. In proposing larger volume/weight criteria, EPA is attempting
to target containers that pose the greatest risk of catastrophic
consequences in the event of failure.
Although most bulk containers used at commercial agrichemical
facilities will be fixed in one position, EPA anticipates that some
pesticide bulk containers may not. For example, some facilities may use
or be visited by pesticide bulk delivery trucks or rail cars. EPA
believes it necessary to require that containment pads, but not
secondary containment units (with potentially greater capacity
requirements), be used for transport vehicles during customary short-
term visits at applicable facilities. However, when such vehicles are
used at one location for prolonged storage or repeated on-site
dispensing of pesticide, the primary function of the vessels shifts
from pesticide transport to pesticide storage or handling. Given the
attendant increase in risks of accumulated leakage and unsafe use in
such situations, EPA reasons that full holding capacity of secondary
containment provisions are warranted. Therefore, Sec. 165.142 would
apply the same containment requirements to fixed bulk containers as to
non-fixed bulk containers that remain at an applicable facility for at
least 14 days. EPA believes that 13 days would adequately accommodate
the on-site tenure of transport vehicles under normal circumstances.
An option EPA considered but decided not to propose would apply
secondary containment requirements only to bulk containers from which
pesticides were dispensed for container refilling operations. This
limited option was discarded because no evidence was found to suggest
that pesticide bulk containers used for refilling operations inherently
are more likely to suffer leaks and spills than bulk containers used
for other purposes (e.g., dispensing to application equipment or
delivery vehicles).
As proposed in Sec. 165.142, a stationary bulk container would be
exempt from the requirements of subpart H if it satisfied any one of
the following conditions:
(1) The container has been cleared of all pesticide that can be
removed by customary methods such as draining, pumping, or aspirating
(whether or not residues have been removed by washing or rinsing).
(2) The container holds pesticide rinsates or wash waters and is so
labeled.
(3) The container holds only pesticides which would be gaseous when
released at atmospheric temperature and pressure.
(4) The container is dedicated and labeled for non-pesticide use.
Section 165.142(a)(2)(i) would allow certain bulk containers that
are out of service to remain at the facility without containment. The
exemption applies even if some pesticide residues remain in the bulk
container, provided that all pesticide that can be removed by customary
methods such as draining, pumping or aspirating has been removed.
However, EPA expects that in most cases, stationary bulk containers
will actually be equipped with secondary containment. EPA also
considered a more stringent criterion; namely, that unless residues
remaining in such containers were further removed by washing or
rinsing, containment would be required. EPA rejected this measure
because it was not clear that the benefit derived from the additional
cleaning would outweigh the rinse-water disposal problems it could
create.
The exemption of Sec. 165.142(a)(2)(ii) for stationary bulk
containers holding pesticide rinsates and wash waters is based on the
fact that EPA currently does not possess sufficient information on the
risks of storage of such dilute pesticides. As discussed in Unit VI.A.4
of this preamble, contamination of soil and ground water has been
associated with improper management and disposal of pesticide rinsates
and wash waters, but the extent to which storage of such materials in
bulk containers has been problematic is not clear. EPA requests
comments to assist in determining conditions under which secondary
containment is appropriate for bulk containers of dilute pesticides and
to help in estimating the numbers of facilities and bulk containers
that may need to be protected.
Today's proposal would exempt from containment requirements bulk
containers that hold pesticides that would be gaseous if released at
atmospheric temperature and pressure. This exemption is based on the
fact that the preponderance of EPA's information on environmental
contamination at commercial agrichemical facilities pertains to soil
and water contamination, not to releases to air. Comments are requested
to clarify whether and the extent to which aerial releases of
pesticides from bulk containers warrant containment measures to protect
human health and the environment.
c. Pesticide dispensing areas covered. Section 165.142(b) sets out
the applicability of containment pad requirements for pesticide
dispensing areas at facilities covered in Sec. 165.141. The term
``pesticide dispensing area'' is defined to include an area in which
pesticide is transferred out of or into a container. Section
165.142(b)(1) would identify four specific conditions under which the
requirements for containment pads in subpart H would apply to pesticide
dispensing areas. These four areas are as follows:
(1) As proposed in Sec. 165.142(b)(1)(i), an area in which
pesticide is dispensed from a stationary bulk container would be
required to meet the containment pad requirements of subpart H.
Containment requirements would apply regardless of the purpose of
dispensing. For example, containment requirements would apply whether
pesticide dispensing is done to refill refillable containers, service
containers, transport vehicles, or application equipment, or to empty
the bulk container prior to cleaning.
The intent of this portion of Sec. 165.142 is to require that at a
minimum, containment pad requirements apply to the area where material
is transferred from the appurtenance of a stationary bulk container
into a receiving vessel, including the area physically covered by the
receiving vessel. Containment pad requirements also would be intended
to apply even if there is no receiving vessel on the pad, such as might
occur when rinsate is discharged from the appurtenance of a stationary
bulk container during container cleaning. EPA is proposing that
containment requirements apply to these areas because large volumes of
pesticides are transferred there and are subject to spillage from
operating practices and mishaps, as well as equipment failures (see
Units VI.A.2 through VI.A.4 of this preamble, for discussion).
(2) Section 165.142(b)(1)(ii) would apply containment pad
requirements to pesticide dispensing areas in which pesticide is
dispensed from any container other than a stationary bulk container for
purposes of refilling a refillable container for sale or distribution.
The area where pesticide is dispensed into the refillable container,
including the area physically covered by the refillable container,
would be required to meet requirements for a containment pad. EPA
believes that containment is warranted in refilling areas for the same
reasons described above for Sec. 165.142(b)(1)(i). Containment
requirements would not apply if pesticide is dispensed from small
containers for purposes other than refilling. EPA requests comment on
whether containment requirements should be broadened to include
dispensing from small containers for other purposes (see further
discussion below).
(3) An integral component of container refilling operations is the
emptying, cleaning, and rinsing of refillable containers in preparation
for refill. During this process, significant quantities of pesticide
concentrates and rinsates may be generated or transferred. Section
165.142(b)(1)(iii) would apply containment requirements to areas where
such activities occur. EPA believes that without structures to
intercept and collect pesticide spills in such areas, safe refill
cannot be assured. Evidence presented in Unit VI.A.4 of this preamble
indicates that environmental contamination can occur not only where
pesticide concentrates are spilled, but also in areas where pesticide
rinsates are routinely dispensed.
(4) Section 165.142(b)(1)(iv) also would apply containment pad
requirements to areas at a facility where pesticides are dispensed from
transport vehicles into stationary bulk containers. This requirement is
predicated on EPA's finding (documented in Unit VI.A.2 and Unit VI.A.3
of this preamble) that mishaps can result in pesticide spills during
dispensing both from (load-out) and into (load-in) stationary bulk
containers. EPA believes that in most situations, pads used for
dispensing pesticide from stationary bulk containers also will be able
to be used as containment pads to accommodate dispensing from transport
vehicles. (See discussion on Sec. 165.152(b)(1) in Unit VI.B.5 of this
preamble for size considerations of pads used for such transport
vehicles.)
EPA considered but rejected two other options pertaining to the
applicability of containment pad requirements. One option would require
containment pads wherever any pesticide container routinely is stored,
emptied, filled, cleaned, or handled at a facility. This broad approach
was not adopted because EPA lacked sufficient data to determine what
type of containment was warranted in different situations. A second,
much more narrow option would apply containment pad requirements only
to pesticide container refilling operations at refilling
establishments. However, environmental data, discussed in Units VI.A.2
and VI.A.4 of this section, suggested that refilling operations are not
likely to be the sole cause of contamination at facilities covered;
activities such as dispensing pesticides from bulk containers into
spray equipment and improper disposal of pesticide rinsates could also
be contributing factors. Thus, this narrow approach was rejected in
favor of the approach proposed in Sec. 165.142.
As proposed in Sec. 165.142(b)(2), a pesticide dispensing area
would be exempted from the containment pad requirements of subpart H
under any of the following three conditions:
(1) If the only pesticides handled in the pesticide dispensing area
are pesticides which would be gaseous if released at atmospheric
temperature and pressure. EPA proposes to defer action on containment
requirements for gaseous pesticides, pending further collection of
information.
(2) If the only pesticide containers refilled within the pesticide
dispensing area were stationary bulk containers protected by a
secondary containment unit that complied with the requirements of this
subpart. This exemption stems from the fact that the portion of a
stationary bulk container where pesticide is dispensed into the
container could fall under the definition of a ``pesticide dispensing
area,'' triggering containment pad requirements. Because the act of
refilling a stationary bulk container will occur only infrequently, but
storage of pesticide in stationary bulk containers will occur on a
prolonged or continuing basis, EPA believes the safeguards of a
secondary containment unit would be more appropriate than the
safeguards of a containment pad. Although the exemption for containment
pad requirements pertains to the stationary bulk container, the area
where pesticide is dispensed out of the appurtenance of the stationary
bulk container (e.g., for filling containers, application equipment,
etc.) would be required to be protected by a containment pad.
(3) If the pesticide dispensing area is used solely for dispensing
pesticide from a rail car that is not a stationary bulk container. EPA
believes that operations involving dispensing from rail cars typically
will involve brief visits to off-load into bulk containers. It is not
clear that containment pads are warranted in such temporary situations,
especially since such pads would be less likely to be able to serve
multiple purposes than would pads where trucks are off-loaded. However,
if a rail car is used as a stationary bulk container, secondary
containment would be required.
Under this proposal, a facility required to install a containment
pad for transfers to and from bulk containers would not be required to
use the pad for filling of application equipment from containers
smaller than bulk containers; nor would it be required to use the pad
for application equipment washing operations. However, it clearly would
be in the facility's interest to use the pad if such operations are
conducted on-site, since spills, leaks, and improper disposal of wash
waters could result in environmental contamination. EPA believes that
requirements for the use of containment pads when cleaning equipment or
when dispensing pesticide from small containers into application
equipment merits further consideration. EPA requests comments on useful
criteria to determine to whom or under what situations containment pad
requirements should apply for containers smaller than bulk containers
and whether the standards proposed today for containment pads would be
appropriate. EPA also requests data reflecting the numbers of
facilities that could be affected by so extending containment
standards.
2. General requirements for containment structures. EPA is
proposing general requirements for containment structures in
Sec. 165.146. Both containment pads and secondary containment units
would be required to meet the standards for materials, design,
construction, operation, inspection, and maintenance proposed in this
section. The proposed standards would apply to structures for dry
pesticides as well as for liquids, since the former can routinely
become exposed to rainfall, wash water or other liquids. The proposal
also would provide a phase-in period, establishing certain interim
standards for existing containment structures and full requirements for
new containment structures.
Section 165.144 would identify existing containment structures as
those for which installation commenced on or before the date 3 months
after the date of publication of the final standards for pesticide
containers and containment in the Federal Register; new containment
structures would be those for which installation commenced after that
date.
Section 165.144 would also provide criteria to distinguish between
new and existing structures. These criteria derive from EPA's Hazardous
Waste Management System regulations issued under the Resource
Conservation and Recovery Act (Ref. 93) and from EPA's Prevention of
Significant Deterioration regulations issued under the Clean Air Act
(Ref. 85). EPA requests comment on whether alternative or supplementary
criteria should be used to define existing and new containment
structures. (See also discussion of compliance dates for new and
existing structures in Unit VI.B.7 of this preamble.)
a. Rigid structures. Section 165.146 would require that the
containment structure be constructed of rigid material, capable of
withstanding the full hydrostatic head (dynamic or static), load, and
impact of any pesticides, precipitation, other substances, equipment,
and appurtenances placed within the structure. Rather than specifying a
list of acceptable construction materials, Sec. 165.146 would leave
open the choice of materials (with a few exceptions), as long as
rigidity performance standards were satisfied.
Containment structures for pesticides and other chemicals such as
petroleum products, solvents, and fertilizers have been constructed
with a variety of materials. Some examples of rigid systems are
reinforced concrete dikes, stainless steel pans, and basins cast from
synthetic polymers. Examples of non-rigid materials are asphalt or
earthen dikes, unfired clay, and portable synthetic materials which can
be rolled up or folded.
Key technical guidance documents (Refs. 28 and 58) recommend that
rigid materials, especially reinforced concrete, be used for structural
support in pesticide containment facilities. Many State pesticide
containment regulations require construction with concrete (Ref. 70).
EPA believes that rigid materials are best able to withstand the full
force of contained materials and any vehicles or other equipment that
might be used on the structure. Although flexible, portable containment
structures may be appropriate in certain other situations, EPA believes
that durable, rigid materials should be required for containment at
facilities covered in this proposed rule.
In Sec. 165.146(a)(2) of today's proposal, EPA would prohibit the
use of earthen materials, unfired clay or asphalt as structural
materials for containment structures. Such materials are not
recommended in technical guidance documents for pesticide containment
systems (Refs. 28 and 58). For containment of very large containers of
chemicals (e.g., tanks with a holding capacity of 100,000 gallons or
more), engineers may seek less expensive alternatives to rigid
containment materials, such as clay-lined earthen berms. However, a
number of significant failures of earthen containment structures have
been documented (Ref. 12). The level of protection afforded by earthen
liners can be degraded by exposure to sunlight and cold cracking and
may be vulnerable to damage from animal activity. Costs associated with
cleanup of pesticide spills inside clay containment structures can be
high, given the likely need to excavate and reconstruct the liner, and
test and dispose of contaminated soil (Ref. 44).
Since the overwhelming majority of the containment systems affected
by today's proposal is anticipated to involve storage and dispensing of
relatively small volumes of pesticides (as opposed to 100,000-gallon
systems), EPA believes that rigid materials would be appropriate.
Comments are requested regarding whether these prohibitions would
subject facilities to undue hardship, and if so, what alternative
safeguards could be proposed to ensure that containment structures
constructed of these materials would function effectively.
b. Hydraulic conductivity. Containment structures must be
sufficiently resistant to penetration by pesticides to prevent the
leaching and release of harmful quantities of pesticide. Section
165.146 proposes that containment structures must meet specific
quantitative criteria for hydraulic conductivity. Section
165.146(a)(3)(i) would specify a standard for hydraulic conductivity of
less than or equal to 1 x 10-6 centimeters per second (cm/sec) for
existing containment structures during an interim period that would
begin 2 years after the final rule is published and would end 8 years
later; thereafter, a more stringent standard of 1 x 10-7 cm/sec or
less would apply to existing structures. (Further discussion of a
proposed interim phase-in schedule for existing structures appears in
this section and in Unit VI.B.7 of this preamble).
As proposed in Sec. 165.146(a)(3)(ii), new containment structures
would be required to achieve a hydraulic conductivity that is less than
or equal to 1 x 10-7 cm/sec 2 years after the publication date of
the final rule. These standards could be attained by using structural
materials; surface sealants and coatings; liners beneath the structure;
or combinations thereof. The hydraulic conductivity standards would
apply for the entire pesticide-bearing portion of the structure.
The proposed hydraulic conductivity criteria pertain to the rate of
water movement through containment material. EPA believes that although
it would be preferable to base the criterion directly on the
permeability of the containment material to the pesticide,
manufacturers of containment materials frequently will not have
available information on permeability performance of their products for
a wide variety of pesticides. However, EPA believes that the rate of
movement of water through the containment material is customarily
measured by manufacturers of containment materials and would provide a
reasonable index for the rate of movement of liquid pesticide.
A hydraulic conductivity standard of less than or equal to 1 x
10-7 cm/sec proposed in Sec. 165.146(a)(3)(ii) was selected for
many of the same reasons it was proposed under RCRA subtitle C for
surface protection (sealants and coatings) of wood preservative drip
pads [see Notice of Proposed Rulemaking in 56 FR 63848, December 5,
1991 (Ref. 95)]. EPA believes that concrete is the material chosen by
most owners of pesticide containment structures. Well-designed and
constructed concrete, when unfractured, has been demonstrated to have a
hydraulic conductivity of 10-7 cm/sec or less. Thus, a hydraulic
conductivity standard of 10-7 cm/sec is essentially a proxy
standard for well-constructed, unfractured, common concrete.
EPA believes that well-constructed, unfractured concrete generally
could serve as an adequate containment material for pesticides. When
suitable materials are used and properly installed, concrete offers the
advantages of structural strength, durability and economy. EPA believes
that when well-constructed concrete is unfractured, it will adequately
retard migration of pesticide through the structure and reduce the risk
of harmful releases of pesticides to the environment. To illustrate the
amount of liquid that could pass through an unfractured concrete
containment structure with a hydraulic conductivity of 10-7 cm/
sec, a 25 ft2 sump that is continually wetted would release 0.05
gallons of material per day.
When exposed to field conditions, concrete is susceptible to
fracturing, and even microscopic cracks can diminish its ability to
retain liquids. Microfractures could allow liquids to permeate many
times more rapidly than material that is on a crack-free structure;
therefore, EPA believes that concrete exposed to field conditions is
unlikely to meet the proposed standard of less than or equal to 1 x
10-7 cm/sec and is unlikely to provide an adequate level of
protection. In addition, recent preliminary findings by the Tennessee
Valley Authority (Ref. 5) indicate that concrete alone may not be an
adequate barrier to prevent the penetration of some agricultural
pesticides. For these reasons, EPA believes that new containment
systems constructed of concrete would require additional protection in
the form of treatment with sealers or coatings, and/or protection from
below with a liner. EPA believes materials are available that can meet
or exceed (i.e., have a lesser hydraulic conductivity value than) 1 x
10-7 cm/sec, although some additional research and technology
transfer may be needed to facilitate the matching of containment
materials to different pesticides and field conditions.
Although a hydraulic conductivity standard of 1 x 10-7 cm/sec
is proposed today for pesticide containment structures as well as in
the rule for wood preservative drip pads, it should be noted that the
two rulemaking initiatives differ regarding the containment materials
to which these standards would apply. For wood preservative drip pads,
the standard applies to surface protection treatments for concrete pads
(i.e., sealants, coatings, covers) but not to liners. Rather than a
hydraulic conductivity standard, liners for wood preservative drip pads
must meet various design, construction, and installation requirements.
In today's proposal, compliance with the hydraulic conductivity
standard could be attained by sealants, by coatings, by structural
materials in the containment structure, or by a liner beneath the
structure.
Under Sec. 165.146(a)(3)(i) of today's proposal, during an interim
period, existing containment structures could be composed of materials
meeting a less stringent hydraulic conductivity standard, namely less
than or equal to 1 x 10-6 cm/sec. This provision is intended to
allow operators to derive up to 10 years additional service (until the
end of the interim period) from existing, concrete containment
structures without applying a coating or sealant, provided that visible
cracks are repaired and that the structure otherwise will be inspected,
maintained, and operated in compliance with requirements proposed in
this section. There is a precedent in the States (Illinois) for using a
hydraulic conductivity standard of 1 x 10-6 cm/sec for pesticide
containment structures.
In selecting a hydraulic conductivity standard for existing
structures, EPA attempted to identify a criterion that would comport
with hydraulic conductivity standards that have been set forth in state
regulations on pesticide containment. Most state regulations do not
cite hydraulic conductivity construction standards, but those that do
typically specify values no less stringent than 10-6 cm/sec (this
value usually applies to liners). EPA is therefore proposing a
hydraulic conductivity standard of 10-6 cm/sec in an effort to
harmonize with state regulations governing existing structures. In
essence, the 10-6 cm/sec standard is intended to serve as a
surrogate standard to represent a containment structure that is
composed of well constructed concrete but that has been exposed to
fracturing conditions in the field.
EPA requests comments on whether hydraulic conductivity standards
are appropriate for existing containment structures or if other types
of criteria should be used to indicate the ability of existing
containment structures to retain pesticides. For example, in place of a
hydraulic conductivity standard, should EPA require that during the
interim period, existing containment structures must be maintained free
of visible cracks and other defects? If this or similar qualitative
standards are proposed, would such requirements be applicable to
concrete as well as to other appropriate containment materials?
EPA believes that less stringent hydraulic conductivity standards
are not appropriate for the long term, since more rapid rates of
penetration may result in significant releases of pesticides to the
environment and also may lead to costly disposal problems when
contaminated concrete structures are decommissioned. Therefore, EPA is
proposing today that for new structures, the effective date for
compliance with the 1 x 10-7 cm/sec hydraulic conductivity
standard would be 2 years after publication of the final rule. EPA
believes it would be prudent for operators of existing concrete
structures to coat or seal their structures as soon as possible with
material meeting the 1 x 10-7 cm/sec standard; however, EPA
realizes that coating or sealing existing structures may not be a
simple task. Bulk containers would need to be removed from secondary
containment units and the containment structures would require thorough
preparation either by scarifying, grinding, or sandblasting, and
vacuuming or a wet treatment involving degreasing, acid treatment, and
neutralization (Ref. 28). Because this may be a significant
undertaking, EPA is proposing to require compliance with the more
stringent hydraulic conductivity standard in synchrony with schedules
for other standards requiring significant structural changes.
Therefore, for existing structures, compliance with the standard of 1 x
10-7 cm/sec would not be required until after an additional 8-year
interim period.
EPA assumes that manufacturers of sealers, liners, and coatings can
provide documentation to verify that their products meet hydraulic
conductivity criteria [see proposed recordkeeping requirements in
Sec. 165.157(b)]. A typical method for measuring the infiltration rate
of water vapor into a synthetic coating or liner is ASTM E96 Procedure
E. EPA would consider this form of verification acceptable and requests
comment on whether other procedures such as ASTM E96 Procedure H should
be considered. EPA does not believe that it would be practicable to
require routine hydraulic conductivity tests of installed materials. In
fact, EPA is unaware of any generally accepted test methods for
determining the permeability of a surface sealer, coating, or cover
once it has been applied. EPA requests comments as to whether owners or
operators of existing containment structures will be able to and should
be required to document that installed containment materials can meet a
standard of 1 x 10-6 cm/sec.
EPA invites other comments regarding the proposed hydraulic
conductivity standards. In particular, commenters are requested to
discuss whether all containment structures (new and existing) should
meet the more stringent standard of 10-7 cm/sec within 2 years of
publication of the final rule. Comments are also solicited on whether
hydraulic conductivity criteria should apply to all types and parts of
containment structures, or whether they should be tailored to match
relative risks of releases. For example, should the hydraulic
conductivity standard for pesticide containment pads be more stringent
than the standard for secondary containment units, since the former are
likely to be subjected more frequently to pesticide spills and rinsate
discharges? Should sumps or other areas where pesticides can routinely
accumulate meet a more stringent standard than other parts of the
containment structure? EPA also requests comments regarding whether the
proposed hydraulic conductivity values of 10-6 and 10-7 cm/
sec are appropriate as standards for containment structures, or, if
not, what factors should EPA consider in proposing alternative
hydraulic conductivity values.
Although a hydraulic conductivity standard is applicable to
concrete and other porous or easily fractured materials, it may be less
applicable to certain other materials (e.g., steel) that may inherently
meet the conductivity standard. EPA requests comments as to whether
alternative language is needed to clarify the acceptability of other
materials in meeting the proposed standard.
Comments also are requested to assist EPA in determining if a
hydraulic conductivity standard is appropriate for liners used beneath
containment structures, or whether alternative design, construction,
and installation criteria should apply to such liners. For example,
when synthetic liners are used for wood preservative drip pads,
regulations at 40 CFR part 264 subpart W and part 265 subpart W [55 FR
50450, December 6, 1990 (Ref. 94) require that they prevent leakage
from the drip pad into adjacent soil and water. Liners for wood
preservative pads must also be constructed of materials that will
prevent drippage/leachate from being absorbed into the liner; the
materials also must have appropriate chemical properties and sufficient
strength and thickness to prevent failure due to pressure gradients,
physical contact with the drippage/leachate to which they are exposed,
climatic conditions, and stresses of installation and daily operation.
The liners also are required to be placed on a foundation or base
capable of providing support to the liner and resistance to pressure
gradients above and below the liner to prevent failure of the liner due
to settlement, compression, or uplift. EPA requests comments to clarify
whether design, construction, and installation standards such as those
applying to liners for wood preservative drip pads should apply to
liners for pesticide containment structures, in lieu of or as a
supplement to the proposed hydraulic conductivity standard.
EPA considered several other approaches to specify the ability of
containment materials to resist penetration by pesticides. One
alternative was the use of specific design criteria (e.g., specifying
type and thickness of concrete, spacing of reinforcement bars, etc.).
Another approach was to require that the structure be constructed of
material that is impermeable or impervious to the pesticide being
stored or handled. Another option was to set a specific length of time
over which the containment structure would be required to retain
spilled material. For example, a spill retention period of 72 hours was
recently proposed by EPA as a standard for secondary containment of
large, aboveground oil tanks under section 311(j)(1)(c) of the Clean
Water Act (Ref. 88). EPA requests comments on whether these or other
qualitative criteria should be used as an alternative or supplement for
hydraulic conductivity.
c. Resistance to pesticides. Section 165.146(a)(4) would require
that containment structures be composed of materials that are resistant
to the pesticide that is being stored or dispensed. Unless containment
materials are resistant, exposure to pesticide could cause them to
become weakened or corroded, or to otherwise deteriorate. EPA believes
that manufacturers of containment materials routinely will be able to
provide documentation to verify that materials are resistant to
particular pesticides. EPA requests comments on whether the term
``resistant to the pesticide'' is clear and/or whether EPA should
define this phrase in the regulations. Comments also are requested to
assist EPA in determining appropriate qualitative or quantitative
criteria for resistance to pesticides.
d. Stormwater control. Precipitation may enter a containment
structure either directly or through stormwater run-on from surrounding
land or structures. The presence of this water on the containment
structure can be undesirable because it diminishes the holding capacity
of the structure and may eventually flush pesticide residues from the
structure to adjacent lands and waters. Even if the structure does not
overfill, if pesticide residues mix with the water, the water may need
to be managed as pesticide. This can create a disposal management
problem if an operator is not prepared to use the pesticide-containing
water according to the appropriate label or if there is not adequate
storage to hold the material until it can be properly used.
In later sections of this preamble (Units VI.B.3, VI.B.4, and
VI.B.5) capacity requirements for containment structures are discussed.
These sections include discussions of requirements that would allow for
retention of direct rainfall and/or the possibility of roofing to
protect containment structures from direct rainfall. In contrast, the
present section of the preamble describes proposed construction and
design requirements to prevent stormwater from entering containment
structures via run-on from adjacent areas.
As stipulated in Sec. 165.146(b)(1), EPA is proposing that at a
minimum, any containment structure must be designed and constructed to
prevent water and other liquids from seeping into it or flowing onto it
from adjacent land or structures during a 25-year, 24-hour rainfall
event. EPA is concerned that operators will find it difficult to
properly manage pesticide-containing stormwater or prevent pesticide
releases from containment structures that are located on poorly drained
areas.
A 25-year, 24-hour rainfall event is commonly used as a design
benchmark for the capacity of secondary containment structures. For
example, the National Pollution Discharge Elimination System (NPDES)
Best Management Practices Guidance Document (Ref. 75) indicates that
containment structures should be designed to retain precipitation from
a 25-year, 24-hour storm to prevent run-off from being released to the
environment. EPA believes that, just as a 25-year, 24-hour storm is a
reasonable criterion for stormwater retention, it would also serve as a
reasonable standard to which pesticide containment structures should be
built to prevent stormwater seepage and run-on from entering the
structure from adjacent lands or structures. EPA requests comments as
to the utility of this specific requirement and whether containment
designers will be able to translate information on 25-year, 24-hour
storm values into appropriate siting/design specifications.
Alternatively, EPA requests comments on whether other flood criteria,
such as a 100-year flood level, would be more appropriate.
EPA is proposing a requirement for stormwater control that is
performance-based rather than design-based. Thus, the proposed approach
would not stipulate that containment walls be constructed to some
minimum height, such as 3 inches or 6 inches. EPA believes that a
performance-based stormwater control requirement will allow owners/
operators flexibility to comply under varying site-specific conditions.
For example, all other things being equal, containment structures built
on well-drained, elevated areas may be constructed with lower curbs/
walls than structures built in depressions. Structures sited on
drainage ways may rely on higher curbs/walls, may install stormwater-
diverting structures (such as berms) uphill, or both. Structures built
in arid areas (and, hence, with less precipitation during a 25-year,
24-hour storm) may generally need lower walls or less elevation than
structures located in regions with more rainfall. Sites with porous
soils and low water tables will drain better than sites with compact
soils and high water tables, and containment structures design can vary
accordingly. If stormwater can drain into the containment structure
from the overhanging roofs of adjacent buildings, gutters or other
methods could be used to divert the stormwater away from the structure.
EPA requests comments on alternative approaches to stormwater
control for containment structures. For instance, rather than
specifying that stormwater run-on must be prevented from entering a
containment area during a 25-year, 24-hour rainfall event, the rule
could provide that, at a minimum, no discharge may take place from a
containment structure during a 25-year, 24-hour rainfall. This approach
would generally comport with typical NPDES requirements; however,
because it would essentially impose capacity requirements on
containment structures, readers should refer to the discussions on
capacity requirements in Units VI.B.3, VI.B.4, and VI.B.5 of this
preamble.
e. Site preparation. This proposal does not include specifications
for site preparation. For example, there is no proposed requirement for
testing the proposed construction site for soil and ground-water
contamination prior to construction. There is also no requirement that
contaminated sites be properly cleaned prior to construction. However,
because recent evidence points to widespread pesticide contamination of
soil and ground water at commercial agrichemical facilities, EPA
strongly urges any person who is contemplating constructing or
purchasing a containment structure, especially at a site with a history
as an agrichemical facility, first to conduct an environmental
assessment of the site. If construction proceeds and significant
contamination is found later, the effectiveness of the structure would
be questioned and the structure may have to be removed in conjunction
with remediation efforts.
f. Support of containers and appurtenances. Section 165.146(b)(2)
would require that containers and appurtenances on containment
structures be protected from damage by personnel and moving equipment.
The need to protect equipment against accidents is supported by EPA's
finding that spills and leaks at pesticide bulk storage and handling
facilities are often related to operator error and equipment failure.
The proposed language would provide several choices in securing
protection, including measures such as the use of supports to prevent
sagging, flexible joints in the event that connections are jarred or
dislocated, and the use of guard rails, barriers, and protective cages.
A number of State pesticide containment regulations require similar
protective measures. As a variation of this requirement, EPA considered
requiring that all appurtenances used to dispense pesticides to or from
containers be protected by containment. For example, a pipe running
from a distant pesticide bulk container to a containment pad would
itself require containment. EPA is not proposing this alternative due
to a lack of information on the practicability of containing all
appurtenances.
g. Configuration of drains and appurtenances. Section 165.146(b)(3)
proposes that for new structures (and existing structures after 8
years), pipes or drains through the walls or base of the containment
structure would not be allowed. An exception would be granted for pipes
through walls separating adjacent containment structures, provided the
structures meet all applicable proposed requirements. EPA believes that
areas in which containment structures are penetrated by plumbing
fixtures are difficult to keep sealed. Moreover, leaks in drains
beneath structures are difficult to detect. The proposed interim period
of 8 years would provide existing facilities the opportunity to
continue operating prior to upgrading.
EPA is concerned that appurtenances that are buried or otherwise
inaccessible to inspection may be sources of significant undetected
leakage. This problem frequently has been documented for buried
appurtenances of petroleum product containers. For example, an EPA
study, ``Causes of Release from UST Systems,'' (as discussed in Ref.
96) concludes that faulty piping, loose fittings and vents cause 84
percent of test failures for ``tightness'' of underground storage tank
systems. (``Tightness'' tests measure changes in product volumes over
time to determine if tank systems are leaking.) External corrosion is a
common source of damage to such underground piping, but natural forces
and accidents also cause piping failures. Piping near the surface is
subject to damage from overloading and from soil heaving during freeze/
thaw cycles. EPA believes that the problem of undetected leakage is
generic to buried appurtenances, regardless of their contents.
Therefore, Sec. 165.146(b)(3) of today's proposal would require that
appurtenances be configured in such a way that if leaks and spills
occur, they can easily be observed.
EPA considered implementing this requirement for all structures
(existing and new) 2 years after the rule is published, but chose to
defer the requirement for existing systems for 8 additional years due
to the possibility that compliance with this provision may require
substantial remodeling costs for existing systems. Thus,
Sec. 165.146(b)(3) of today's proposal would defer for an interim
period of 8 years the requirement that appurtenances be configured in
such a way that any leakage that might occur can be readily observed.
Comments are requested to assist EPA in determining whether leak
detection systems, hydrostatic testing, or other methods would better
assure the integrity of appurtenances.
h. Operations. Section 165.146(c) proposes general standards for
the operation of containment structures. As discussed in Units VI.A.2
through VI.A.4 of this preamble, operational problems such as
overfilling containers or equipment, allowing hoses to become
dislodged, leaving pesticide transfer operations unattended, and
improperly disposing of spills and rinsates have contributed to
contamination of soil and ground water. Indeed, even after remediation
of commercial agrichemical facilities and installation of new
containment systems, contamination often recurs because operators
apparently continue to engage in improper pesticide handling and
disposal practices (Refs. 20 and 80). The protection offered by
containment structures is intended to address spills or leakage after
it occurs, but cannot alone ensure that pesticide storage or transfer
operations will not result in environmental contamination. EPA believes
that structural safeguards must be coupled with sound operational
procedures to ensure safe refill and reuse of containers.
Section 165.146(c)(1) would require any containment structure
(secondary containment unit or containment pad) to be operated in a
manner that prevents pesticides, including residues in rinsates and
rainwater, from escaping the structure to surrounding areas. This
section would also require that all materials containing pesticide
residues be handled in accordance with label directions and applicable
regulations.
Section 165.146(c)(2) would require the owner or operator to ensure
that an individual be present whenever pesticides are being transferred
at the containment structure. This proposed requirement is based on
information gathered by EPA suggesting that significant spills can
occur at agrichemical bulk storage facilities when pesticide transfer
operations are left unattended (see Units VI.A.2 and VI.A.3 of this
preamble). EPA also believes that the person in attendance should be
trained in the proper methods of pesticide storage and dispensing and
versed in the facility's spill control and recovery procedures. EPA is
not proposing that such training be mandatory and formally certified,
but invites comments as to whether such a measure should be required.
Because vandalism has caused major pesticide spills at agrichemical
facilities, Sec. 165.146(c)(3) would require that lockable valves on
stationary bulk containers (as proposed by subpart G for bulk
containers at refilling establishments) be locked closed when the
facility is not attended.
Section 165.146(c)(4) would require that the owner or operator
ensure that contained spills and leaks are collected and recovered to
the maximum practicable extent and in a manner that ensures protection
of human health and the environment. Certain technical guidance
documents recommend immediate cleanup of spills and leaks at
containment structures (Refs. 28 and 58). Timely cleanup of the
containment structure can increase its service life by preventing long-
term corrosive conditions, can reduce the volume of pesticide-
containing rainwater that needs to be disposed (in unroofed
structures); and can minimize the potential for human or animal
exposure to pesticides. In addition, long-term retention of spilled
materials in a containment structure would displace some of its holding
capacity, increasing the probability of releases during periods of
heavy rainfall or other unanticipated events.
As proposed, Sec. 165.146(c)(4) would require that spills or leaks
be cleaned up as soon as practicable and no later than by the end of
the day in which pesticides have spilled or leaked in the containment
structure. EPA requests comments on alternative provisions to require
immediate cleanup of spills, or to allow a set period of time (e.g. 24
hours) until cleanup.
Section 165.146(c)(5) would require the owner or operator to ensure
that recovered materials containing pesticides be handled as prescribed
by label instructions and applicable Federal, State, and local
regulations. EPA also requests comments on any alternatives to the
proposed containment requirements that would reduce the likelihood of
spills and leaks, and thus reduce the potential quantity of material
that would have to be recovered and managed.
i. Inspection and maintenance. General requirements for inspection
and maintenance of containment pads and secondary containment units are
proposed in Sec. 165.146(d). Without vigilance and regular upkeep, even
relatively small defects can lead to hazardous and costly uncontrolled
releases of pesticides. Since the proposed rule does not set forth
environmental monitoring or leak detection requirements that would warn
operators of containment defects, EPA believes that requirements for
regular inspections and maintenance are crucial for ensuring safe bulk
storage and refill operations.
Section 165.146(d)(1) would require the monthly inspection of all
stationary bulk containers and their appurtenances and containment
structures for external signs of damage or leakage. This requirement
would apply during periods in which pesticides were being stored or
handled in the containment area. Regular inspections are proposed to
facilitate the timely detection and correction of containment flaws and
thereby prevent pesticide discharges to the environment. The proposed
monthly inspection schedule for containment structures generally
comports with inspection requirements of applicable State regulations.
Since weekly inspection schedules were recently proposed by EPA for
wood preservative drip pads (Ref. 95), EPA considered whether weekly
inspection schedules also would be appropriate for containment
structures for agricultural pesticides. EPA assumes that pesticide
containment structures addressed in today's proposal generally will be
smaller and (during operating hours) will have a greater frequency of
personnel visits per unit area than will wood preservative drip pads.
Additionally, pesticide spillage would be required to be cleaned up
sooner after it occurred on containment structures for agricultural
pesticides than it would for wood preservative pads. EPA believes that
these factors would lead to defects being noted more quickly in
containment structures for agricultural pesticides than in drip pads
for wood preservatives. Therefore, EPA is proposing a monthly rather
than a weekly inspection schedule for containment structures covered in
today's proposal. EPA requests comments as to whether a monthly
frequency of inspection is appropriate, or whether a different
inspection schedule should be established.
Section 165.146(d)(2) proposes that any cracks and gaps in a
containment structure or appurtenance must be sealed with material that
is resistant to the pesticide being stored or handled and that also
satisfies applicable requirements for hydraulic conductivity. Expansion
cracks and joints are said to be the biggest sources of releases from
concrete secondary containment structures (Ref. 53). Cases of
uncontrolled releases of agrichemicals (sometimes involving thousands
of gallons of product) have been attributed to poorly sealed joints and
cracks in containment structures (e.g., Ref. 52). EPA requests comments
as to whether manufacturers of caulking, waterstops, and other types of
sealing materials readily can document that their products conform to
the proposed standards for hydraulic conductivity and pesticide-
resistance.
Section 165.146(d)(3) would prohibit the storage of pesticides on a
containment structure that fails to meet the requirements of subpart H.
Dispensing of pesticides would also be prohibited, unless the
dispensing is done to remove pesticides promptly until suitable repairs
could be effected. By the provision for ``prompt removal,'' EPA intends
that the owner or operator would be required to remove all of the
pesticide as promptly as practicable. At some facilities, such removal
may be achieved immediately by transferring the pesticide from a flawed
containment structure to one that is intact. In other cases, it may be
necessary to dispatch a transport vehicle to remove pesticide until
repairs are completed. However, EPA believes that most repairs will be
relatively minor and should be able to be completed in less time than
would be required to remove pesticide from the defective structure.
EPA solicits comments as to whether there should be additional
inspection and maintenance requirements, such as a criterion that
containment structures be inspected annually (or every 3 or 5 years) by
a registered professional chemical, civil, industrial, or petroleum
engineer and be certified to meet all applicable material, structural,
and design criteria.
j. Detection of leaks from containment structures. Even well-
designed containment structures may develop leaks. For example, failed
caulking, small fractures, pinhole leaks, and related structural flaws
may develop unnoticed and lead to unanticipated release of pesticide
through the containment structure. EPA considered two options to
address such problems. One approach would require the installation and
regular monitoring of leak detection systems beneath the containment
structures and of ground-water monitoring wells nearby. The second
option would not require leak detection systems, provided the
structures were subjected to regular visual inspections and proper
maintenance. EPA believes that certain proposed requirements would
lessen the need for rigorous containment leak detection requirements.
For example, prohibitions on drains and buried appurtenances and a
proposed requirement that stationary bulk containers be elevated so
that any leaks can readily be observed (discussed in Unit VI.B.3 of
this preamble) would reduce the possibility of containment leaks
escaping notice. The use of structural materials, surface sealants and
coatings to meet hydraulic conductivity standards would also reduce the
need for leak detection systems, since EPA believes that all these
materials would be relatively amenable to visual inspection for
defects.
Although the proposed rule adopts this second approach, EPA
requests comments as to whether leak detection systems and ground-water
monitoring requirements would be more appropriate in some or all
instances. For example, if a containment structure meets the
requirement for hydraulic conductivity through the use of an underlying
liner, should leak detection/ground-water monitoring systems be
required because the liner cannot be visually inspected? Should leak
detection systems be required preferentially for containment pads over
secondary containment units, since the former more routinely come into
contact with spilled pesticides? Should leak detection systems be
required for outdoor containment structures rather than indoor
structures, since outdoor structures are subject to more damaging
exposure to the elements? Should leak detection systems be installed
under the entire containment structure, or only under the sump, since
this is the area of the structure with the greatest exposure to spilled
materials?
3. Containment for stationary liquid bulk containers. A containment
structure that is designed and constructed to contain pesticide spills
from stationary bulk containers is referred to in the proposal as a
secondary containment unit. Stationary bulk containers may hold either
liquid pesticide or dry pesticide. As proposed in subpart H, secondary
containment units would be required to satisfy general requirements for
containment structures in Sec. 165.146, and additional requirements
specific to containment of stationary bulk containers in Sec. 165.148
(for liquid pesticides) or in Sec. 165.150 (for dry pesticides).
Section 165.148 would specify standards for the capacity of secondary
containment units for liquid bulk containers, as well as certain
construction, design, inspection, and maintenance requirements.
a. Capacity. EPA believes that any secondary containment unit
should have sufficient holding capacity to retain not only the small
leaks and spills encountered in routine conditions, but also major
spills from bulk containers. To develop quantitative standards for
capacity, EPA evaluated various factors, especially capacity
requirements in State containment rules.
Two capacity requirements for secondary containment units
protecting containers with liquid pesticides are set forth in today's
proposal in Sec. 165.148(a): the first would cover existing structures
for an interim period of 8 years; the second would cover new structures
(and existing structures after the interim period had lapsed). The
interim standard for existing structures [in Sec. 165.148(a)(1)] would
require a minimum capacity of 100 percent of the volume of the largest
stationary bulk container in the existing secondary containment unit,
plus an additional 10 percent (110 percent, total) of the capacity of
the largest container if the storage area is not protected from
rainfall, plus the volume displaced by containers and appurtenances.
This interim capacity standard for existing secondary containment units
in Sec. 165.148(a)(1) is proposed on the basis of general conformance
with current or proposed State containment regulations.
The standard in Sec. 165.148(a)(2) for new containment structures,
and for existing structures after the interim period in
Sec. 165.148(a)(3), would require a minimum capacity of 110 percent of
the volume of the largest bulk container, plus an additional 15 percent
(125 percent, total) of the capacity of the largest container if the
storage area is not protected from rainfall, plus the volume displaced
by containers and appurtenances. (This capacity requirement is referred
to hereafter as the 110/125 standard.)
The 110/125 standard for capacity should prove adequate to contain
most spills. The 110 percent criterion for storage areas under a roof
provides sufficient capacity to hold the contents of a full container,
plus a margin of safety to accommodate sloshing from sudden releases or
other unforeseen displacement events. The 125 percent criterion for
storage areas without roofing adds an extra margin of safety for
retention of precipitation.
EPA has considered the following rainfall-based alternative to the
proposed 110/125 standard for new containment structures: 110 percent
of the volume of the largest bulk container, plus an additional
capacity adequate to contain precipitation from a 25-year, 24-hour
rainfall event if the storage area is not protected from rainfall, plus
the volume displaced by containers and appurtenances. (This option is
also described in the discussion on stormwater run-on control
requirements, in Unit VI.B.2 of this preamble.) With this option,
required containment capacity would vary according to local rainfall
patterns. EPA believes that either the rain-based standard or the
proposed 110/125 standard would provide adequate protection, although
most States with containment regulations do not use a 25-year, 24-hour
storm criterion for containment capacity. Comments pertaining to the
relative advantages and disadvantages of these capacity criteria are
requested.
Comments are requested to aid EPA in characterizing the procedures
involved in retrofitting existing structures to meet more stringent
capacity requirements. Discussion of the feasibility of either
modifying the containment facility or the configuration of containers
or other approaches to meet more stringent capacity requirements would
be particularly helpful.
In developing the proposed capacity requirements, EPA also
considered but elected not to propose a requirement that secondary
containment units be protected from the direct introduction of
precipitation by a roof or similar cover. EPA believes that in many
cases, the advantages of keeping rainwater out of containment
structures will significantly outweigh the costs of installing a roof.
However, in arid regions, a roof may not be cost-effective. EPA
requests comments as to whether, and under what circumstances, a roof
or similar cover should be required to protect secondary containment
units from the direct introduction of precipitation.
b. Ability to observe leaks from containers. Stationary bulk
containers that rest flush upon containment structures are exposed at
the base to increased moisture, which may make them more susceptible to
corrosion and failure. The outside base of such containers cannot be
inspected readily for flaws, and they also hinder inspection, cleanup,
and maintenance of the covered portion of the containment structure. In
the event that both the bulk container and the covered area of the
containment structure develop defects, pesticide could leak to the
environment undetected.
In Sec. 165.148(b)(1), EPA proposes to require that stationary bulk
containers be positioned to allow for the observation of leakage from
the base of the containers. This requirement would help alert operators
that containers are leaking, allowing them to make timely cleanups and
repairs. However, EPA believes that design constraints of certain
existing containment structures and bulk containers may necessitate
major retrofitting efforts to meet this requirement. Thus, for existing
secondary containment units, EPA is proposing in Sec. 165.148(b) to
defer this requirement for an interim period of 8 years.
Section 165.148(c) would require that during the interim period,
monthly inventory and reconciliation be conducted for the contents of
bulk containers that are not elevated. The proposed method of inventory
and reconciliation would help to determine if the container was leaking
by comparing the quantity of material actually measured in the bulk
container versus the quantity that would be expected (as determined by
adding or subtracting deposits or withdrawals from the container to the
quantity measured in the bulk container at the previous month's
inventory). However, EPA believes that variables that can also
influence container volume, such as thermal expansion, container
deformation, and evaporation and condensation within the container,
will make this method inadequate for indicating small leaks. EPA
requests comments on the suitability of other means of checking non-
elevated containers for leaks, such as periodic volumetric tests that
can compensate for the effects of thermal expansion.
c. Anchored bulk containers. Liquids from spilled pesticides,
rainwater, water from fire suppression, and other sources can
accumulate in containment structures. As the level of liquid rises
inside the structure, it can exert significant floatation forces
against partially filled or empty containers (Refs. 4 and 28).
Floatation can cause stationary bulk containers to become uprooted,
collide with other containers and equipment, and spill. For these
reasons, Sec. 165.148(b)(2) would require any stationary bulk container
that is protected by a secondary containment unit either to be
adequately elevated or anchored to prevent floatation in the event that
the secondary containment unit fills with liquid. The intent of this
provision is to allow facilities the choice of either elevating
containers sufficiently to avoid floatation, or to anchor the
containers (or both, if desired). EPA believes that the need to anchor
bulk containers will be greatest for flat-bottomed containers that are
not elevated. Since non-elevated bulk containers would be permissible
at existing structures during the interim period, EPA is proposing that
the provision for anchoring become effective during the interim period
(and thereafter) and apply to both new and existing secondary
containment units.
4. Containment for stationary dry bulk containers. Section 165.150,
would require that, in addition to meeting the general requirements for
containment structures posed in Sec. 165.146, containment structures
for stationary dry bulk containers must have a capacity of at least 100
percent of the volume of the largest stationary dry bulk container
within the containment structure, compensating for any volume displaced
by containers and appurtenances. This requirement would apply to new
containment structures, but would be deferred for an 8-year interim
period for existing structures.
EPA believes that secondary containment for dry bulk containers is
appropriate because spills of dry pesticides could mix with rainwater,
fire suppression water, or other liquids to reach and contaminate soil
and water supplies. Therefore, the proposed rule would require that
secondary containment units for dry pesticides be designed to hold 100
percent of the capacity of the largest bulk container in the
containment unit. This proposed approach differs from the requirements
established in the few State rules that address storage of large
quantities of dry pesticide. States generally define dry ``bulk''
quantities as 100 pounds to 300 pounds of material. They also require
storage under a roof and, if outdoors, on pallets or raised concrete
platforms. While 100-pound to 300-pound quantities may be addressed by
roofing and flooring requirements, EPA believes that larger quantities
defined as bulk in this proposal (more than 2,000 kilograms) pose
potentially greater risks of serious environmental contamination if a
release associated with exposure to water occurs, and therefore warrant
protection similar to that proposed for liquid bulk containers.
Rather than require that secondary containment units for dry bulk
containers be designed to contain a specific volume, EPA considered
requiring that secondary containment units for dry pesticides be
designed to extend a specified distance beyond the perimeter of the
bulk container. However, EPA lacked sufficient information to determine
what would constitute an adequate distance for containment. EPA
requests comments regarding factors that could be considered for
setting the dimensions of secondary containment units for dry bulk
containers. Comments are also solicited as to whether secondary
containment units for dry bulk pesticide containers should be protected
by roofing or similar cover from the direct introduction of
precipitation (see related discussion in Unit VI.B.3. of this
preamble).
5. Containment for pesticide dispensing areas. Section 165.152
proposes standards for the capacity, design, and construction of
containment pads at pesticide dispensing areas. As proposed,
containment pads would be required to meet the requirements of
Sec. 165.152 in addition to the general requirements for containment
structures set forth in Sec. 165.146.
Because undersized pads can allow pesticide spills and leaks to
escape, holding capacity is a key element of containment pad design.
EPA is proposing in Sec. 165.152(a) a minimum containment pad capacity
of 1,000 gallons, or, if no container or pesticide holding equipment on
the pad exceeds a capacity of 1,000 gallons, the proposed minimum
capacity of the pad would be at least 100 percent of the capacity of
the largest container or pesticide holding equipment on the pad. This
proposed minimum standard is based primarily on a review of current or
proposed containment pad regulations in the States. EPA believes that
this standard could be met by most, if not all, existing State-
regulated containment pads and that it affords an adequate level of
environmental protection.
EPA considered, but is not proposing, a requirement that pesticide
containment pads be protected by roofing or similar cover from the
direct introduction of precipitation (see related discussion in Unit
VI.B.3. of this preamble). EPA requests comments as to whether, and
under what circumstances protection from the direct introduction of
precipitation should be required for containment pads.
Section 165.152(b) would require containment pads to meet certain
design and construction requirements. By proposing in
Sec. 165.152(b)(1) that the containment pad be designed and constructed
to intercept leaks and spills of pesticides that may occur in a
pesticide dispensing area, EPA intends that the containment pad be of
sufficient dimensions to cover areas where pesticides are transferred
into or out of containers or their appurtenances, including the
container itself. EPA recognizes that at some facilities, tanker trucks
delivering pesticide for sale or distribution to the facility will be
considerably larger than containers or equipment normally used on the
containment pad. Because such deliveries are not expected to be
frequent, EPA is proposing in Sec. 165.152(b)(1) that the pad be at
least large enough to protect the area where the pesticide delivery
hose or device connects to the vehicle, but not necessarily large
enough to accommodate the entire vehicle. This size exception for
containment pads is not intended to apply to those transport vehicles
that are used routinely in the day-to-day operation of the facility,
such as trucks with nurse tanks.
Container refilling and cleaning and similar operations are likely
to result in routine exposure of containment pad surfaces to
pesticides. To facilitate the collection of pesticides,
Sec. 165.152(b)(2) would require that the base of the containment pad
be sloped toward a liquid-tight sump. EPA believes that a graded
surface will lessen the time that pesticides remain on the pad and
facilitate pesticide collection, which in turn will reduce the
likelihood of pesticide escaping the pad. The requirement for sloped
surfaces and liquid-tight sumps would be deferred for 8 years for
existing containment pads. This interim period would allow operators of
facilities that currently do not meet the proposed requirement to
derive further use of their systems before retrofitting.
The structural integrity of the sump is critical because it is the
portion of the pad with the greatest exposure to spilled pesticide and
rinsates. EPA requests comments on whether, and the extent to which,
performance criteria for the sump should differ from general
containment requirements. For example, should sumps be constructed of
double-walled stainless steel with observation ports to check the
annular space for leaks?
Section 165.152(b)(3) would require a means, such as manually
activated pumps, of removing collected materials from the sump. Pumps
that are automatically activated would not be allowed if they lack an
automatic mechanism to prevent overflows at the receiving vessel.
6. Integrated systems. Section 165.153 of the proposal would permit
facilities to design containment structures that would combine
secondary containment units and containment pads. EPA believes that
such combined systems would be acceptable, provided that the separate
requirements for each of the component structures are satisfied. Thus,
a secondary containment unit could include within its boundaries a
pesticide containment pad, as long as the integrated system complied
with all applicable standards. Conversely, a pesticide containment pad
could include as a component a secondary containment unit for a
stationary bulk container. Section 165.153 would also allow for
multiple stationary bulk containers to be protected within a single
secondary containment unit. EPA requests comments as to whether the
storage of multiple pesticide products within a common containment
structure should be restricted in some situations. For example, should
integrated systems be prohibited if spills could result in mixtures of
pesticides whose labels do not allow application to the same crop?
7. Compliance dates. Section 165.156 identifies the dates on which
compliance with requirements in this proposal would take effect,
distinguishing compliance dates for new versus existing structures. As
noted in Unit VI.B.2 of this preamble, Sec. 165.144 would define a new
containment structure as a containment structure for which installation
has commenced more than 3 months after publication of the final rule in
the Federal Register. An existing containment structure would mean a
containment structure for which installation has commenced earlier than
the reference date (i.e., on or before 3 months after the date of
publication of the final rule in the Federal Register). Section
Sec. 165.144 would also describe criteria under which installation
would be considered to have commenced.
Section 165.156(a) would require that as of 2 years after
publication of the final rule, new containment structures would comply
fully with all applicable requirements of subpart H. EPA believes that
21 months between the reference date for new structures (3 months after
publication) and the compliance date (24 months after publication)
would provide a reasonable period of time for new structures to be
planned and built in compliance with the full requirements of subpart
H. EPA believes that further shortening the period before compliance is
required may not provide ample time for facilities to be constructed in
locales with significant seasonal constraints on construction.
Conversely, a longer period before compliance would unnecessarily
prolong the environmental risks of spills and leaks at commercial
agrichemical facilities.
Section 165.156(b) would establish an interim period that would
commence 2 years after the date of publication of the final rule and
would end 10 years later (net interim duration: 8 years). During the
interim period, existing containment structures would be required to
meet those requirements identified in subpart H as interim requirements
for existing containment structures, and to fully meet all other
applicable requirements. As proposed in Sec. 165.156(c), after the
interim period, interim requirements for existing facilities would no
longer apply and all facilities would be required to meet the
requirements of new containment structures.
In proposing this phase-in approach for existing structures, EPA
believes that certain structural standards are crucial to safe
containment. These critical standards include:
(1) Construction with rigid materials.
(2) Use of pesticide-resistant materials.
(3) Hydraulic conductivity no greater than 1 x 10-6 cm/sec.
(4) Stormwater run-on protection for a 25-year, 24-hour storm.
(5) Protection of appurtenances and containers.
(6) Sealed joints and cracks.
(7) Pad capacity requirements.
(8) Minimum secondary containment capacity of 100/110 percent
(indoors/outdoors) of the volume of the largest container.
(9) Anchoring stationary bulk containers that are susceptible to
floatation.
If an existing structure does not already comply with these
standards, EPA believes that appropriate modifications can be readily
implemented at existing structures within 2 years.
Certain other standards are proposed to be deferred for a total of
10 years for existing structures because many existing structures that
have been constructed at considerable expense may have design or
structural features that are not amenable to upgrading without major
modification. EPA believes that the cost of immediate retrofitting of
such structures may outweigh incremental gains in protection and may
place undue burdens on owners of such structures. EPA has concluded
that these standards should be phased in over time for existing
structures. Standards that EPA proposes to defer for an interim period
include:
(1) Hydraulic conductivity less than or equal to 1 x 10-7 cm/
sec.
(2) Plumbing configured to facilitate leak detection.
(3) No drains or pipes penetrating the containment structure.
(4) Minimum secondary containment capacity based on 110/125 percent
(indoors/outdoors) of the largest liquid container and on 100 percent
of the largest dry bulk container.
(5) Bulk containers elevated for leak observation.
(6) Pads sloped and with sumps.
The 10-year compliance period proposed in Sec. 165.156(b) is
estimated to represent roughly one-half to two-thirds of the 15- to 20-
year service life of an average well-built and well-maintained
containment structure. The expected service life of containment
structures is difficult to predict as it can vary with the quality of
materials used, construction practices, operational practices, exposure
and maintenance practices. EPA believes that 15-20 years may be a
reasonable estimate for most existing structures, although some may
last considerably longer and others may need replacement or renovation
sooner than this time frame. EPA also believes that the majority of
existing structures will have been constructed considerably more than
10 years before the interim compliance period expires.
It is believed that by allowing structures 10 years to complete
upgrades, EPA would minimize impacts on owners of existing structures
who have invested large capital expenditures to meet state requirements
and those who voluntarily upgraded structures. The 10-year time frame
would allow owners to recoup the benefits from the depreciation of the
capital investment and financially prepare to upgrade their aging
structure to meet the full requirements of new structures. EPA believes
that the proposed maximum time limit would allow owners/operators of
existing structures a variety of ways to plan for and accomplish an
orderly transition toward compliance with the standards for new
structures.
Although 10 years would be the maximum time period allowed, EPA
encourages a more rapid transition where possible, so that the benefits
of these improvements can be realized sooner. EPA requests comments and
information as to whether an interim time different from the proposed
10-year period (2 years + 8 years) would be more appropriate.
EPA considered but is not proposing a requirement that standards
for new structures would apply when existing structures are repaired or
renovated, as well as when they are replaced. EPA requests comments on
the advisability of such a requirement and on how to define when it
would apply.
EPA considered other strategies to address existing structures. One
option, based on containment structure age rather than a fixed 10-year
period, would have allowed existing structures to operate under certain
minimal standards until they were 15 years old, when the full
requirements would apply. Existing structures that were cited for spill
violations or that expanded in size by 50 percent or more would be
required to meet the full requirements. An underlying assumption for
this option is that older containment structures are more likely to
result in releases of pesticides than are newer structures. Under this
option, a containment structure that is 15 years in age or older (as
well as those of unknown age) at the 2-year compliance date would be
required to meet the standards of a new structure by the 2-year
compliance date. A structure that is 10 years old at the 2-year date
would be required to retrofit 5 years later. The major difference
between this approach and the proposed fixed-interim period approach is
that under the age-based system, older existing structures would be
required to upgrade to comply with new structure standards much sooner
than under the fixed interim period approach. On the other hand, under
the age-based schedule, very recently built existing containment
structures would be required to comply with standards for new
structures later than would such structures under the proposed
approach.
EPA solicits comments and information pertaining to the benefits
that could be obtained by phasing in containment standards based on age
rather than on a fixed interim period. Information is also requested
that may further reveal whether, and to what extent, older containment
structures may pose significantly more of a threat to human health and
the environment than more recently built containment structures.
Another option would have applied the full requirements (i.e.,
those proposed today for new structures) to all structures, regardless
of whether the structures were new or existing. Another option would
have left intact the interim standards for existing structures, but
would require that some or all upgrades be completed sooner than 10
years after the publication date of the final rule. Under this option,
a time-tiered compliance schedule would be possible, with some interim
standards being replaced with full standards earlier than others. EPA
requests comments regarding whether these or other options would
provide cost-effective approaches for containment.
EPA also requests comments on whether the proposed reference date
to distinguish new from existing structures (3 months after the date of
publication of the final rule in the Federal Register) is appropriate.
For example, EPA considered an option that would move the reference
date to coincide with the compliance date, effectively allowing any
facility that commenced construction prior to the 2-year compliance
date to be designated as existing structures. EPA discarded this option
because the interim standards for existing structures were developed
for structures that would otherwise need to retrofit extensively. EPA
reasoned that structures for which installation had not commenced until
3 months after the publication of the final rule in the Federal
Register should be able to be built to comply with the full set of
requirements.
8. Recordkeeping. Section 165.157(a) would require retention of
records for a 3-year period to verify the facility's compliance with
applicable requirements of the proposed rule. Section 165.157(a)(1)
would require that records be retained to document inspections and
maintenance of containment structures, stationary bulk containers, and
their appurtenances. Information to be recorded would include the name
of the person performing the inspection or maintenance activity, the
date of the activity, conditions noted, and maintenance performed.
Section 165.157(a)(2) proposes recordkeeping requirements for
monthly inventory and reconciliation of pesticides in stationary bulk
containers that do not readily allow for inspection for possible
leakage (see also discussion on Sec. 165.148(c), in Unit VI.B.3 of this
preamble). Information proposed to be logged for each applicable
container would include the name of the product stored, quantity
reported from previous inventory, quantities dispensed, measured
quantity remaining, and reconciliation. These logs would need to be
recorded only during the interim period.
Proposed Sec. 165.157(a)(3) would require that records be kept to
document the duration over which pesticide remains in one location at
the facility in any bulk container not protected by a secondary
containment unit that meets the requirements of subpart H. This
proposed requirement is intended to assist in determining whether the
bulk container has exceeded the 13-day residence criterion that
triggers requirements for secondary containment of stationary bulk
containment.
Section 165.157(b) would require the retention of written
confirmation of hydraulic conductivity and pesticide-resistance, as
applicable, for as long as the containment structure is in use, and 3
years thereafter.
VII. Labeling Requirements for Pesticides and Devices
A. Background
The provisions of 40 CFR 156.10(i)(2)(ix) require that the labeling
of a pesticide product bear the directions for storage and disposal of
the pesticide and its container required by part 165, and that these
directions be grouped under the heading ``Storage and Disposal.'' The
current part 165 does not contain specific labeling directions. EPA's
Pesticide Regulation Notice 83-3 (cited in this preamble as PR Notice
83-3) (Ref. 64) provides that the requirements of Sec. 156.10(i)(2)(ix)
may be satisfied if the registrant provides on each pesticide label
certain statements instructing the user on pesticide residue removal
procedures and container disposal. PR Notice 83-3 sets out statements
for a variety of pesticide products and container types.
B. Today's Proposal
1. Amendments to part 156. EPA proposes to amend 40 CFR part 156 to
add Sec. 156.140, Identification of container type, and Sec. 156.144,
Residue removal instructions, under new subpart H entitled ``Container
Labeling.'' To accommodate the requirements of these proposed additions
as well as the proposed amendments to 40 CFR part 165, the following
amendments to Sec. 156.10 would be necessary:
(1) Section 156.10(i)(2)(ix) would refer to the new additions to
part 156 (Sec. 156.140 and Sec. 156.144).
(2) Section 156.10(d)(7) would require that a space be reserved on
labels intended for use on refillable containers so the net weight or
measure of content can be marked in by the refiller prior to
distribution or sale of the pesticide.
(3) Section 156.10(f) would require that a space be reserved on
labels intended for use on refillable containers so the refiller can
mark in its EPA-assigned establishment number prior to distribution or
sale of the pesticide.
A pesticide product is considered misbranded if its label does not
bear the registration number, assigned under FIFRA section 7, of the
establishment in which the pesticide was produced [FIFRA sec.
2(q)(1)(D)]. Also, it is misbranded if the net weight or measure of the
contents is not affixed to the container [FIFRA sec. 2(q)(2)(C)(iii)].
The proposed blank spaces on the label would accommodate this
information.
2. Identification of container categories. EPA is proposing in
Sec. 156.140 to require statements to be placed on the container label
or the container itself that would identify the container for the user
as either a nonrefillable or refillable container. Placement would be
limited to the container label or the container because labeling that
is not attached to the container may become separated from the product
and thus unavailable to the user. EPA believes this statement is
necessary because of reports of the reuse of existing containers in
ways that pose unacceptable risks, or actual harm, to humans,
livestock, and the environment. These reports include the reuse of
pesticide containers as water jugs and flotation devices, and the reuse
of larger containers that have been cut in half to serve as animal feed
troughs and barbecues. The intent of the label language would therefore
be to make clear that nonrefillable containers cannot be refilled with
anything and refillable containers can be refilled only with pesticide.
Two statements are proposed for pesticides in nonrefillable
containers. The first statement would prohibit the reuse or refilling
of the container. Nonrefillable containers would not be allowed to be
refilled or reused because they would not have to meet the proposed
refillable container integrity standards. (Today's proposal would
require that refillable containers be designed and constructed to
facilitate safe refill and reuse.) The statement also would recommend
that the user offer the container for recycling. EPA does not consider
recycling to be a direct ``reuse'' of the container for the purposes of
this requirement. For example, the container could be recycled by
having its physical form demolished, and the materials from which it
was made could be reused to manufacture new containers.
The second statement proposed in Sec. 156.140(a)(2) for pesticides
in nonrefillable containers would require that a lot number or other
identification code to identify the batch of pesticide product be
marked permanently on the container label or the container itself by
the registrant or the producer. The usefulness of this batch code
depends on its availability to enforcement personnel, and because
labeling that is not securely attached to the container may become
separated from the product, EPA would limit the placement of the code
to either the container label or the container.
While EPA is not proposing to require a mandatory recordkeeping or
tracking system for these batch codes/lot numbers, EPA believes batch
codes/lot numbers would facilitate the safe use of containers by
allowing EPA to identify and trace pesticides that are found to be
adulterated, unstable, off specification, or otherwise defective. When
used in conjunction with the EPA establishment number (currently
required by EPA in Sec. 156.10(f) to appear on the label or the
immediate container), the batch codes/lot numbers would allow for the
tracing of defective products back to the place of manufacture, and
identification of other products packaged during the same time.
Registrants would be able to choose the type of identifying code
they wish to use for this purpose. Several manufacturers already place
(stamp or ink jet) batch codes, lot numbers, or other identifying codes
on containers voluntarily to aid in quality control, production
assessment, and identification of the time and date of manufacture.
The statement for refillable containers would identify the
container as a refillable pesticide container and prohibit the user
from refilling the container with substances other than pesticides.
EPA's PR Notice 83-3 (Ref. 64) does not distinguish between refillable
and nonrefillable containers. As discussed later in this preamble, the
label statements of PR Notice 83-3 will be amended as necessary to
reflect changes made by this rule.
3. Residue removal statements. Section 156.144(a) would require
that all labels bear instructions for removal of pesticide residues
prior to container disposal.
EPA realizes that the residue removal requirements proposed today
may not be appropriate for every pesticide product and is therefore
proposing in Sec. 156.144(b) that registrants may request modifications
and waivers from the residue removal label language.
Section 156.144(c) would require residue removal statements to
appear under ``Container Cleaning,'' a proposed subheading under the
Storage and Disposal heading of the Directions for Use. The addition of
this subheading would standardize the organization of the ``Storage and
Disposal'' section, thereby increasing the ease of compliance with
label requirements.
The proposed Sec. 156.144 segregates the requirements for residue
removal label statements into Sec. 156.144(d) for nonrefillable
containers and Sec. 156.144(e) for refillable containers in order to
decrease any confusion that may ensue from establishing different
requirements for the two container categories.
4. Residue removal statements for nonrefillable containers. Section
156.144(d) proposes that the labels of all pesticides packaged in
nonrefillable containers must bear instructions for residue removal
prior to disposal. EPA intends to establish specific label language for
each container/formulation category at the same time as the
corresponding laboratory residue removal standards are established in
Sec. 165.104. Accordingly, proposed today in Sec. 156.144(d)(1) are
label instructions for the rigid/dilutable category (as discussed in
Unit IV.B.7.b. of this preamble. This category includes products that
are meant to be diluted prior to application and that are packaged in
rigid containers, i.e., those containers constructed of materials such
as glass, metal, and rigid plastics). Because PR Notice 83-3 (Ref. 64)
also specifies container disposal instructions, EPA intends to amend PR
Notice 83-3 to reflect the establishment in regulation of these rigid/
dilutable statements and instructions. At this time, EPA does not
intend to change the residue removal language that is specified in PR
Notice 83-3 for the other container categories. Additional changes will
be made to PR Notice 83-3 as new container/formulation categories have
their residue removal standards and instructions established in
regulation.
Although allowable by FIFRA section 19(f)(1)(C), EPA does not
propose to exempt products intended solely for household use that are
rigid/dilutable from the residue removal label language requirements of
Sec. 156.144(d)(1). In many instances, the same pesticide product in
the same container is sold for agricultural or industrial use, as well
as for use in the home, yard, or garden. The current PR Notice 83-3
(Ref. 64) states that all products intended solely for household use
packaged in rigid containers (e.g., bottles, cans, jars) must bear the
statement, ``Rinse thoroughly before discarding in trash.'' The
proposed container rinsing label statements would require the user to
use a specific residue removal procedure. EPA specifically requests
comments on whether rigid/dilutable products that are distributed and
sold for household use by consumers should be exempted from
Sec. 156.144(d)(1) and on any other exemptions that may be appropriate
and, if so, what alternative residue removal procedure should be
provided for these containers.
It is possible that household pesticide users might experience some
difficulty properly adding the container cleaning rinsate to the use
mixture or using the rinsate itself as a use solution. EPA believes
that an educational outreach program addressing proper rinsate
management may alleviate many potential problems. Another option would
be to require registrants to include on the label detailed instructions
on how to properly add the rinsate to the application mixture or to use
the rinsate as a use solution. EPA requests comments on the
appropriateness and feasibility of such an educational program and/or
requiring rinsate management directions on the labels of household
products. If the rinsate can't be added to the use solution or used
directly for some reason, the disposal methods available to the
household pesticide user include disposing of the rinsate in the trash
and pouring the rinsate down the drain. EPA requests comments on the
appropriateness of these two potential methods for managing the rinsate
from household pesticide containers. In addition, EPA requests comments
on whether there are circumstances in which it would be more
appropriate to not create rinsate from household pesticide containers
by requiring that the label include directions to wrap the container in
newspaper and discard in the trash instead of rinsing instructions.
The proposed label statements pertaining to the rigid/dilutable
category consist of two elements: a statement on timing of the residue
removal and a statement that includes at least one residue removal
(rinsing) procedure.
a. Timing of the residue removal procedure. EPA considers the
timing of the residue removal procedure to be a critical factor in
residue removal effectiveness. EPA therefore proposes in
Sec. 156.144(d)(1)(i) that users be required to clean containers
immediately after emptying out the useful contents of the container.
The Report to Congress (Ref. 65) identifies the timing of the
rinsing procedures as a critical element of effective residue removal.
When rinsing is not performed immediately after the emptying of the
useful contents of the container, the residue dries on the inside and
outside of the container. Many liquid formulations are particularly
difficult to remove once they have dried. Container disposal becomes
more difficult when pesticide residues cannot be removed. This is
especially true for pesticide container recycling and collection
programs where pesticide residues are a major concern. For example,
three letters to EPA from the Minnesota Department of Agriculture (Ref.
23) summarizing pesticide container recycling programs reported the
rejection of containers with visible pesticide residues and that the
residues were a greater problem for the containers that were not rinsed
immediately after emptying. A plastic pesticide container collection
program in Iowa (Ref. 16) reported that 50 percent of the containers
collected were rejected by landfill operators because of the presence
of colored or dried residues in the containers as a result of improper
rinsing.
Surveys conducted in various States show that many users are not
aware of the importance of the timing of their container rinsing
practices. One example is a survey, conducted in Ohio, that reported
that 14 percent of the applicators surveyed indicated they did not, or
they only sometimes, rinsed their containers after emptying them (Ref.
48). Additionally, 45 percent of the users surveyed strongly agreed and
48 percent agreed that ``It is not necessary to rinse used containers
if they are locked up away from others.''
Users may not be aware of the importance of timing because label
statements generally do not require rinsing to be performed at any
specific time, nor do any of the residue removal statements found in PR
Notice 83-3 (Ref. 64) specify the timing of residue removal. User
compliance with this proposed label statement should increase the
number of containers that can enter container collection and recycling
programs, thereby reducing the difficulties now experienced by users
seeking disposal options for their empty containers.
b. Establishing detailed residue removal statements. The current
Sec. 156.10 does not require registrants to place specific residue
removal instructions on their labels. PR Notice 83-3 (Ref. 64)
instructs registrants to add triple rinse requirements to their labels
for rigid containers (metal, plastic, glass) but does not set out the
triple rinse or equivalent procedures. Triple rinsing as a means of
cleaning containers was originally derived from dilution principles
used in laboratories and was adopted as a practical procedure for
pesticide users. EPA is proposing to establish detailed triple rinse
and pressure rinse procedures to clearly communicate to the user the
elements of the cleaning procedure that are critical to rinsing
efficiency. Today's proposal would require the placement of either
procedure on the label, with the option of including both. EPA requests
comments on whether registrants should be required to place both triple
and pressure rinsing statements on the label to allow users to use
either container cleaning procedure.
The critical elements of the triple rinse statement are based on
the laboratory triple rinse methodology that EPA is proposing in
Sec. 165.106. By requiring users to follow a similar methodology, EPA
hopes to assure a high level of cleaning efficiency under typical field
conditions where the variables of water (varying pH, salinity,
temperature, etc.), air temperature, and relative humidity are less
controllable.
Section 156.144(d)(1)(ii)(A) proposes the triple rinse procedure
for dilutable liquid pesticide formulations, whereas
Sec. 156.144(d)(1)(iii)(A) proposes the triple rinse procedure for
dilutable dry pesticide formulations. The statements differ only by a
phrase in the first sentence, which instructs users to empty the
remaining pesticide concentrate from the container prior to rinsing.
The phrase ``and continue to drain for 30 seconds'' that is found in
the statement for liquid formulations is not part of the dry
formulation statement because dry materials do not ``drain'' as liquids
do.
The proposed pressure rinse instructions are modeled after rigorous
procedures currently used in the field, and are generally considered to
result in a degree of residue removal efficiency equivalent to triple
rinsing (Refs. 31 and 65). The results of the studies in the Report to
Congress generally indicated comparable residue removal for the two
methods. EPA concludes that pressure rinsing is at least as efficient
as triple rinsing in removing pesticide residues from containers (Ref.
65). Section 156.144(d)(1)(ii)(B) proposes the pressure rinse procedure
for dilutable liquid pesticide formulations, whereas
Sec. 156.144(d)(1)(iii)(B) proposes the pressure rinse procedure for
dilutable dry pesticide formulations. As with the triple rinse
statements, these two statements differ only by a phrase in the first
sentence pertaining to the emptying of pesticide concentrate from the
container prior to rinsing.
EPA considered proposing an additional pressure rinse procedure
that specified recirculation via a pump for larger nonrefillables, such
as drums. EPA requests comments on whether the proposed pressure
rinsing procedure is appropriate for larger nonrefillable containers.
EPA estimates that the triple rinsing instructions proposed today
will take approximately 5 minutes to perform, whereas the pressure
rinsing procedure would take approximately 2 minutes. EPA is evaluating
the efficiency of shorter triple rinse procedures (Ref. 69). EPA
requests comments on the time burden of the proposed rinsing
procedures, and the voluntary submission of data on residue removal,
including in particular the cleaning efficiency of any suggested
shorter triple rinse and pressure rinse procedures. EPA also requests
comments and data on alternative residue removal procedures.
No field residue removal standard is proposed today. The laboratory
residue removal standard proposed in Sec. 165.104 is to ensure that
container design and formulation characteristics would facilitate
residue removal. Registrants -- not users--would have to meet the
laboratory standard. By establishing a requirement in Sec. 165.104 that
a pesticide product must meet a laboratory residue removal performance
standard, EPA believes a high level of residue removal from containers
will be achieved when the user follows the label instructions, even
under less than optimal field conditions. A field experiment conducted
on existing pesticide products using triple rinse procedures less
stringent than those proposed today reported levels of 99.9 percent
removal from several container types, showing that this triple rinse
procedure can remove a significant amount of residue (Ref. 3).
5. Non-water diluents. The laboratory residue removal procedure
proposed in Sec. 165.104 uses water as the diluent. Even if a product
has complied with Sec. 165.104, it is possible that a registrant may
request EPA to allow modification of the label instructions to require
users to clean the container with a nonwater diluent. Under proposed
Sec. 156.144(d)(1)(iv), EPA may grant the request if certain conditions
are met. Handling of the rinsate generated during residue removal must
be in accordance with the label. Reuse of the rinsate cannot be
accomplished unless the non-water diluent is permitted by the label to
be used in application. If reuse in application is not permitted, then
the rinsate must be collected and stored for eventual disposal.
EPA is proposing in Sec. 156.144(d)(1)(iv) to allow the use of non-
water diluents to clean containers if the registrant shows that the use
of a non-water diluent is necessary and proposes appropriate
instructions. The residue removal instructions would have to be
modified to identify the diluent. The instructions may allow the
rinsate to be added to the application equipment if the label
``Directions for Use'' permit application of the resulting rinsate. If
the ``Directions for Use'' do not identify the non-water diluent as an
allowable addition to the pesticide, the label would have to specify
collection and storage of the rinsate in lieu of use.
EPA must have approved, in writing, the modification of the residue
removal instructions before the pesticide product can be distributed or
sold.
6. Future addition of residue removal statements. EPA is proposing
to hold Sec. 156.144(d)(2) in reserve for the residue removal
statements of other container/formulation categories. EPA acknowledges
that the residue removal procedures proposed for rigid/dilutables may
not be appropriate for all container and package types (such as paper
bags) or formulations (e.g., ant/roach/fly traps, baits, and other non-
dilutable or ready-to-use pesticide products). EPA requests comments
and data on alternative residue removal procedures for container/
formulation types other than rigid/dilutable.
7. Label statements for refillable containers. Section 156.144(e)
would require that the labels of all pesticides packaged in refillable
containers bear statements and instructions for residue removal prior
to disposal.
EPA is proposing in Sec. 156.144(e)(1) a statement to require users
to clean refillable containers prior to disposal. In
Sec. 156.144(e)(2), EPA is proposing to require the registrant to
develop and place on the label a cleaning procedure to be used prior to
disposal of the container. See Unit V.B.11 of this preamble for a
discussion of this provision.
In Sec. 165.124, EPA is proposing to require liquid minibulk
containers to be equipped with tamper-evident devices to minimize the
potential of pesticide product becoming contaminated. EPA considered
but decided not to propose a label statement informing users that if
they present a liquid minibulk container with a damaged tamper-evident
device for refilling, the container could not be refilled with
pesticide unless it was cleaned and a new tamper-evident device was
installed. Cleaning and installing a new device may incur a cost to the
user. A possible label statement that might suffice to alert the user
to this issue is ``If the tamper-evident devices on this container are
damaged, then the container must be cleaned and new devices must be
installed before refilling.'' EPA requests suggestions and comments on
the need for a label statement concerning tamper-evident devices.
8. Compliance dates. EPA is considering three options for
compliance schedules and requests comments on these schedules, as
described below, or on alternatives to these schedules:
(1) Compliance with the proposed part 156 amendments would be
required no later than the compliance date of the proposed part 165
residue removal requirements.
(2) Compliance with the proposed part 156 amendments would be
required the next time a label amendment of any type is requested by
the registrant (voluntary request) or required by EPA, or by the
compliance date of the proposed part 165 residue removal requirements,
whichever is earliest.
(3) Compliance with the proposed part 156 amendments would be
required the next time a label amendment of any type is requested by
the registrant (voluntarily request) or required by EPA, but would not
be postponed longer than 1 year past the compliance date of the
proposed part 165 residue removal requirements.
VIII. Upcoming Effluent Limitations Guidelines for Pesticide
Formulators, Packagers, and Repackagers
A. Purpose
The goal of the Clean Water Act (33 U.S.C. 1251 et seq.) is to
achieve zero discharge of wastewater pollutants to the waters of the
United States. Under the Clean Water Act (CWA), EPA is developing
Effluent Limitations Guidelines and Standards (effluent guidelines) for
the Pesticide Formulating, Packaging, and Repackaging (PFP) industrial
category. EPA expects that the effluent guidelines will affect, among
other facilities, the same refilling establishments as are affected by
today's bulk containment proposal (40 CFR part 165, subpart H). EPA
seeks to develop a regulatory approach to the effluent guidelines for
PFPs that is consistent with the bulk containment requirements proposed
today. The purpose of this part of today's Notice is to inform
interested parties that EPA is developing these CWA regulations for
scheduled proposal in January 1994, to describe EPA's anticipated
approach to these regulations, and to provide advanced notice to
parties who are interested in the opportunity to comment on the January
1994 proposed rulemaking.
B. Applicability
The PFP effluent guidelines will apply to facilities engaged in
pesticide formulating, packaging, and repackaging; this includes
refilling establishments (considered a type of ``repackager''). The EPA
database (see Unit VIII.D of this preamble) established to support the
PFP effluent guidelines currently includes refilling establishments. It
does not include the other types of facilities covered by today's bulk
containment proposal; i.e., commercial applicators and custom blenders.
Therefore, EPA expects that the effluent guidelines being developed for
PFPs will not apply to commercial applicators or custom blenders.
C. Background
Pesticide formulating and packaging operations currently are
regulated by the Best Practicable Technologies (BPT) Effluent
Guidelines for the Pesticide Chemicals Point Source Category,
promulgated in 1978 (40 CFR part 455 subpart C). This effluent
guideline set a BPT limitation of ``no discharge for process wastewater
pollutants'' for PFP facilities that discharge directly to lakes,
streams, rivers, or other waters of the United States (``direct
dischargers''). Facilities that discharge to publicly owned treatment
works (POTWs) (``indirect dischargers''), are not covered by the BPT
limitations.
D. Expected Approach
Effluent guidelines establish limitations on the pollutants
discharged into waters of the United States from industrial point
sources. Pollutant limitations are based on the best performance
achievable by appropriate control technologies, including in-process
and wastewater treatment technologies.
EPA surveyed a sample population of the pesticide formulating and
packaging industry in 1990. Included among the facilities surveyed were
companies that repackage pesticide products, many of which are
refilling establishments. EPA obtained responses from 188 refilling
establishments.
Of those refilling establishments, 135 reported generating
wastewater or rinsate from rinsing their bulk tanks and associated
equipment or rinsing the other refillable containers. Forty-two
companies also reported having to manage and dispose of some pesticide-
containing stormwater. The most frequently reported means of managing
these pesticide-containing rinsates and stormwaters was through
application according to label requirements. This management practice
was reported by 149 companies.
The management of pesticide-containing rinsates and stormwaters by
application in accordance with the label is currently practiced by most
refilling establishments in the eastern and midwestern United States.
The most common practice in California is to treat the pesticide-
containing rinsates and stormwaters and reuse the treated water.
California's practices are different due to the diversity of
agriculture and number of pesticides used during the year. Since most
of California's agricultural region experiences net evaporation, there
is apparently not any problem associated with an excess or accumulation
of water needing management or disposal.
The bulk containment system requirement for refilling
establishments proposed in today's Notice (40 CFR part 165, subpart H)
provides for the containment of rinsates, spills, or leaks and
stormwater that may contain pesticides. EPA preliminarily believes that
these proposed requirements are consistent with the control
technologies the Agency is considering as the basis for the PFP
effluent guidelines and standards for pesticide refilling
establishments. EPA data appear to show that zero discharge to surface
waters is technically feasible at refilling establishments, since 98
percent of these establishments are now achieving it. Through the
construction of bulk containment as proposed today, pesticide-
containing waters could be contained and held for reuse according to
the label, thus achieving zero discharge to surface waters. Therefore,
EPA anticipates that zero discharge may be the basis for the proposed
effluent guideline for refilling establishments. This zero discharge
requirement would apply to the rinsates and stormwater falling within
the contained area. The zero discharge requirement would prohibit
discharges by refilling establishments both to surface waters and to
POTWs.
E. Pollution Prevention
EPA is exploring source reduction opportunities and applications of
the environmental management hierarchy in developing effluent
guidelines (see Unit II.D of this preamble). While today's bulk
containment proposal (subpart H) focuses on preventing the pesticide
product from becoming a source of pollution, the effluent guidelines
effort focuses on identifying opportunities to eliminate or reduce the
volume of pesticide-containing wastewaters discharged to surface waters
by refilling establishments. EPA is looking at ways to reduce these
discharges by reducing the generation of wastewater and/or reusing
these wastewaters.
Historically, the effluent guidelines program has based its
limitations and standards on the best performance of control
technologies demonstrated within the industry or transferred from other
industries. This has included pollutant reductions achieved through:
(1) Process changes.
(2) Recycling or reuse at the production process stage.
(3) Recycling or reuse following treatment.
(4) Treatment only.
EPA notes that some refilling establishments currently apply the
principles of source reduction as follows:
(1) Avoid creating a contaminated stormwater stream by enclosing
pesticide bulk storage tanks and loading pads under a roof.
(2) Prevent the stormwater from being contaminated through better
housekeeping, such as prompt cleanup of spills and leaks, and increased
inspection and maintenance to avoid leaks.
(3) Recover product value contained in rinsates through reuse when
applying pesticides.
At the time of the proposal of the PFP effluent guidelines, EPA
will request comment on a number of issues related to refilling
establishments, including the technical practicality and feasibility of
the practices listed above and their economic achievability at
refilling establishments. EPA will also solicit information on whether
other source reduction practices should be considered.
F. Schedule
EPA's proposed effluent guidelines regulation for the pesticide
formulators and packagers industry (40 CFR part 455), which would
include the effluent guidelines regulation for refilling
establishments, is scheduled to be issued in January 1994. Promulgation
of the effluent guidelines regulation is scheduled for August 1995.
IX. Relationship to Other Programs
Certain laws administered by EPA and other agencies may affect the
design of pesticide containers or procedures and standards for removal
of residue from pesticide containers. This section identifies the laws
that EPA considers to have the most significant impact on pesticide
containers. The description of these laws is for informational purposes
only; no changes are being proposed in the laws described below.
Nothing in this proposal, if ultimately implemented, is intended to
alter obligations under other statutes. However, EPA solicits comment
on any changes that should be made to this proposal to aid in
coordinating with these or other applicable laws and regulations.
A. Resource Conservation and Recovery Act (RCRA)
Requirements under RCRA may affect the handling of pesticide
containers under certain circumstances. RCRA Subtitles C and I are
described briefly below.
FIFRA sections 19(f)(3) and 19(h) specify that FIFRA section 19
does not affect the requirements or authorities of RCRA. Accordingly,
this proposal does not alter any existing RCRA requirements, and any
applicable RCRA provisions will apply in addition to the provisions of
any final rule issued under FIFRA section 19. In addition, FIFRA
section 19(f)(1)(B)(iv) specifies that the residue removal regulations
may be coordinated with requirements for container rinsing under RCRA.
As outlined below, this proposal would provide for coordination in this
area.
1. Hazardous waste requirements. Subtitle C of RCRA creates a
cradle-to-grave system for managing hazardous wastes. RCRA Subtitle C
regulations include requirements for generators, transporters, and
others who handle hazardous wastes. The regulations cover any ``solid
waste'' (defined at 42 U.S.C. 1004 and 40 CFR 261.2) that is listed as
a hazardous waste or exhibits a characteristic of hazardous waste, as
set out in part 261. Pesticides and pesticide containers that are
discarded or intended to be discarded may qualify as hazardous wastes
if they are listed under Sec. 261.33 (discarded commercial chemical
products, off-specification products or manufacturing intermediates,
container residues, and spill residues), or if they exhibit a
characteristic of hazardous waste as described in part 261 subpart C,
and are not otherwise exempt from regulation.
A hazardous waste remaining in a container is not subject to
Subtitle C regulation if, among other things, the container is
``empty'' as defined in Sec. 261.7. A container is ``empty'' if the
wastes are removed pursuant to Sec. 261.7(b)(1) or (b)(2), or, in the
case of an acute hazardous waste, the container has been triple rinsed
or otherwise cleaned pursuant to Sec. 261.7(b)(3). It is EPA's intent
that triple rinsing as provided in this proposal would meet the
requirements of Sec. 261.7(b)(3), thus meeting the directive in FIFRA
section 19(f)(1)(B)(iv).
2. Underground storage tanks. RCRA Subtitle I provides for the
development and implementation of a comprehensive regulatory program
for ``underground storage tanks'' (USTs), defined at 42 U.S.C. 6991 and
40 CFR 280.12 as tanks that are used to contain an accumulation of
``regulated substances'' and whose volume (including underground pipes
connected thereto) is 10 percent or more below ground. Regulated
substances include petroleum or substances defined as hazardous under
the Comprehensive Environmental Response, Compensation, and Liability
Act of 1980 (CERCLA) (except hazardous wastes regulated under RCRA
Subtitle C). CERCLA hazardous substances, enumerated at 40 CFR part
302, include a number of pesticides. UST requirements at 40 CFR part
280 include standards for new tanks as well as requirements for leak
detection, closure, corrective action, and financial responsibility.
EPA is not aware of the extent of industry use of USTs to store
agricultural pesticides, and therefore has not made specific provision
in subpart H of this proposal for containers that may be subject to UST
requirements. EPA specifically solicits comment on the use of
underground tanks to store agricultural pesticides and on the preferred
means of coordinating UST and FIFRA requirements (e.g., by exempting
containers regulated under the UST program from the FIFRA requirements
for bulk containers).
B. Spill Prevention, Control, and Countermeasures (SPCC)
Under section 311(j)(1)(C) of the Clean Water Act (CWA), EPA has
promulgated regulations at 40 CFR part 112 (known as the SPCC
regulations) for the prevention of oil spills into navigable waters and
adjoining shorelines. The regulations apply to facilities that, because
of their location, could reasonably be expected to discharge oil into
navigable waters or adjoining shorelines. Part 112 includes spill
prevention procedures, methods, and equipment requirements for non-
transportation related facilities with total aboveground oil storage
capacity greater than 1,320 gallons (or greater than 660 gallons
aboveground in a single tank) or buried underground oil storage
capacity greater than 42,000 gallons. On October 22, 1991 (Ref. 88),
EPA proposed revisions to these regulations clarifying the mandatory
nature of the rule requirements governing SPCC plans.
Because the definition of ``oil'' under CWA section 311 is very
broad (including oil ``of any kind and in any form''), it could
potentially include pesticides that contain oil or are oil-based. EPA
expects that comparatively few of the facilities covered by today's
proposal would be subject to SPCC requirements. For those few, however,
both today's proposed rule and the SPCC requirements would apply.
C. Occupational Safety and Health Administration (OSHA) Requirements
The Occupational Safety and Health Act (U.S.C. 2601 et seq.)
addresses occupational safety and health hazards by establishing
requirements for employers and employees and authorizing OSHA to
establish mandatory occupational safety and health standards.
Tanks and containers that are used to store flammable and
combustible liquids in occupational settings are subject to OSHA
requirements under 29 CFR 1910.106. For storage tanks, Sec. 1910.106(b)
contains design and construction requirements, including standards for
materials, spacing, venting, drainage and diking, fire and flood
resistance, and testing for strength and tightness. Section 1910.106(c)
contains specifications for piping, valves, and fittings. Section
1910.106(d) sets out design and construction requirements for
containers and portable tanks, and also contains specifications for
storage areas.
D. Department of Transportation (DOT) Hazardous Materials Regulations
The Hazardous Materials Transportation Act of 1974, (49 U.S.C. 1801
et seq) authorizes DOT to designate as hazardous materials those
materials that may pose unreasonable risk to health and safety or
property, and regulate the handling and transportation of such
materials.
DOT regulates the transportation of hazardous materials at 49 CFR
parts 171 through 180 (Hazardous Materials Regulations) by prescribing
rules for, among other things, the manufacture, marking, and testing of
the packaging or container for the hazardous material. A hazardous
material is defined at 49 CFR 171.8 as a substance that has been
determined by the Secretary of Transportation to be capable of posing
an unreasonable risk to health, safety, and property when transported
in commerce. DOT lists specific hazardous materials at 49 CFR 172.101
and 172.102, and also defines several categories of hazardous materials
in 49 CFR part 173.
Some pesticides classify as hazardous materials. For such
pesticides, the containers would have to comply with DOT's requirements
(if the pesticide is being transported in commerce) as well as the
container design rules being proposed today. There would be some
overlap between DOT's hazardous materials regulations and EPA's
container design regulations. More specifically, DOT's testing
requirements for non-bulk packaging at 49 CFR part 178 include drop-
test requirements similar to EPA's proposed drop-test regulations for
refillable minibulk containers. EPA does not intend to subject
pesticide containers to two sets of drop test requirements. If a
registrant is required to package its pesticide in containers that meet
these DOT testing requirements, then such containers will be considered
to satisfy EPA's proposed drop test requirement. Additionally, EPA
believes that containers manufactured to DOT specifications would meet
EPA container integrity requirements. Thus, if a pesticide is required
to be transported in a particular DOT specification container, then
that container would be likely to meet EPA's proposed container
integrity requirements for nonrefillables at Sec. 165.102(b), for
minibulk containers at Sec. 165.124(c), or for bulk containers at
Sec. 165.124(f)(1), whichever applies.
X. Statutory Review Requirements
As required by FIFRA 25(a), this proposal was submitted to the U.S.
Department of Agriculture (USDA) for review and comment. USDA elected
not to comment officially on this proposal.
This proposal was submitted to the Committee on Agriculture of the
U.S. House of Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the U.S. Senate. EPA did not receive
comments on this proposal.
The FIFRA Scientific Advisory Panel (SAP) waived its review of this
proposal.
XI. Public Docket
EPA has established a public docket (OPP-190001) containing the
material used to develop this proposed rule, as well as all of the
material referenced in the References section below. The public docket
is open from 8 a.m. to 4 p.m. Monday through Friday, and is located in
Rm 1132, Cyrstal Mall #2, 1921 Jefferson Davis Highway, Arlington,
Virginia.
XII. References and Support Documents
1. Archer, T., ``Removal of 2,4-Dichlorophenoxyacetic Acid (2,4-D)
Formulations from Noncombustible Pesticide Containers,'' Bulletin of
Environmental Contamination and Toxicology, 13, 44-51 (1975).
2. Association of American Pesticide Control Officials. ``SFIREG
Survey Report Regarding Agrichemical Site Remediation and Disposition
of Certain Agrichemical Containing Materials,'' (1992).
3. Braun, H.E., et. al. ``Efficiency of Water Rinsing for the
Decontamination of Used Pesticide Containers,'' Archives of
Environmental Contamination and Toxicology, 12, 257-264 (1983).
4. Broder, M. Tennessee Valley Authority, ``Containment of
Fertilizers and Pesticides at Retail Operations,'' TVA/NFERC-91/3.
Circular Z-291. Muscle Shoals, AL (1991).
5. Broder, M., D. Nguyen, and A. Harner. Tennessee Valley
Authority, ``Effects of Fertilizer and Pesticide on Concrete,''
presentation to American Society of Agricultural Engineers,
International Summer Meeting, Charlotte, NC, (1992).
6. Buzicky, G. Minnesota Department of Agriculture, [Costs for
cleanup of agrichemical dealerships in Minnesota], Personal
communication to U.S. EPA, summarized in memorandum by D. Howard,
November 11 (1991).
7. Callier, D. U.S. EPA, Region 7, [Information on bulk repackaging
and cross-contamination], Personal communication to attendees of
Technical Meeting on Bulk Repackaging Issues, May 4 (1993).
8. Conover, W.J. Practical Nonparametric Statistics, 2nd edition,
New York, Wiley and Sons (1980).
9. Dade County Environmental Resources Management. ``Agrichemical
Mixer-Loader Wells in Dade County, Florida: Potential for Groundwater
Pollution,'' Miami, Florida (1989).
10. Dwinell, S. Florida Department of Environmental Regulation,
``Final Report: Jackson County Pesticide Container Recycling
Demonstration Project,'' (1991).
11. Dwinell, S. Florida Department of Environmental Regulation,
``Final Report: South Florida Pesticide Container Recycling
Demonstration Project,'' (1991).
12. Elsner, G. Minnesota Department of Agriculture, ``Earthen Dikes
as Secondary Containment for Fertilizers,'' (1991).
13. Fawcett, R.S. ``Big Spring Revisited,'' Agrichemical Age,
(October, 1989).
14. Frank, R., et. al. ``A System for Rinsing Herbicide Residues
from Drums During Highway Right-of-Way Spray Operations,'' Bulletin of
Environmental Contamination Toxicology, 39, 680-687 (1987).
15. Frieberg, D. Iowa Fertilizer and Chemical Association,
``Environmental Cleanup of Fertilizer and Agricultural Chemical Dealer
Sites,'' (1991).
16. Frieberg, D. Iowa Fertilizer and Chemical Association, ``Final
Report on Iowa Pesticide Container Recycling Project'' (1990).
17. Frieberg, D. Iowa Fertilizer and Chemical Association, ``Iowa
Pilot Project: Less than 56 Gallon Repackaging,'' (1990).
18. Gilding, T. National Agricultural Chemicals Association,
[Results of NACA pesticide container survey], Personal communication to
U.S. EPA, October 12 (1989).
19. Good, G. and A.G. Taylor. Illinois Environmental Protection
Agency, ``A Review of Agrichemical Programs and Related Water Quality
Issues,'' Illinois Environmental Protection Agency Report, Springfield,
Illinois (1987).
20. Habecker, M. A. Wisconsin Department of Agriculture, Trade
Consumer Protection, ``Environmental Contamination at Pesticide Mixing/
Loading Facilities: Case Study, Investigation and Remedial Action
Evaluation,'' (1989).
21. Hallberg, G. Cooperative Extension Service, ``Agricultural
Chemicals and Groundwater Quality in Iowa: Status Report, 1985,'' Iowa
State University, Ames, IO (1985).
22. Hallberg, G. ``Overview of Agricultural Chemicals in Ground
Water. Agricultural Impacts on Ground Water: A Conference,'' National
Well Water Association (1986).
23. Hansen, R. Minnesota Department of Agriculture, [Results of
pesticide container collection programs], Personal communications to
U.S. EPA, October 4, 1990, November 1, 1990, January 28, 1991 (1990-
1991).
24. Hansen, R. and L. Palmer. Minnesota Department of Agriculture,
``Pesticide Container Collection and Recycling in Minnesota,''
Pesticide Waste Management: Technology and Regulation, American
Chemical Society, Washington, DC (1992).
25. Hsieh, D., et. al., ``Decontamination of Non-combustible
Agricultural Pesticide Containers by Removal of Emulsifiable
Parathion,'' Environmental Science and Toxicology, 5, 826-829 (1972).
26. Illinois Department of Agriculture and Illinois State
Geological Survey, ``Agrichemical Facility Site Contamination Study''
(1993).
27. Jennings, G.D. North Carolina Cooperative Extension Service,
``Pesticides in Private Wells in Moore and Hoke Counties,'' Draft
report, North Carolina State University (1991).
28. Kammel, D., R. Noyes, G. Riskowski, and V. Hofman. ``Designing
Facilities for Pesticide and Fertilizer Containment,'' MidWest Plan
Service-37, Iowa State University, Ames, Iowa (1991).
29. Kelleher, K. Houston County Recycling Coordinator,
[Observations from a pesticide container collection program], Personal
communication to U.S. EPA, October 24 (1990).
30. Lamberton, J., et. al., ``Pesticide Container Decontamination
by Aqueous Wash Procedure,'' Bulletin of Environmental Contamination
and Toxicology, 16, 528-535 (1976).
31. Leasure, J.K. ``Triple Rinsed -- Or Equivalent,'' Southern
Illinois University, unpublished report (1978).
32. Lohafer, Iowa Department of Agriculture and Land Stewardship,
[Results of minibulk sampling], Personal communication to U.S. EPA,
December 7 (1990).
33. Long, T. ``Groundwater Contamination in the Vicinity of
Agrichemical Mixing and Loading Facilities,'' Illinois Agricultural
Pesticides Conference [includes updated and supplemental data] (1989).
34. MacDonald, B. Mitchell Systems Corporation, ``Summarization of
Nebraska Agrichemical Spill Data,'' memorandum to U.S. EPA, July 17
(1991).
35. Magnusson, M. Minnesota Department of Agriculture, [Summary of
the Minnesota Bulk Pesticide Repackaging Survey], Personal
communication within the Minnesota Department of Agriculture, January
15 (1993).
36. Michigan Department of Agriculture. ``Agricultural Chemicals in
Michigan Groundwater Pilot Survey of 1989,'' Pesticide and Plant Pest
Management Division (1989).
37. Michigan Department of Agriculture. ``Environmental Stewardship
and the Michigan Department of Agriculture: A Report to Governor John
Engler'' (1993).
38. Midwest Agricultural Chemicals Association, Inc. ``Revised
MACA-75 Manufacturer Specification and User Guidelines for Portable
Agri-Chemical Tanks,'' June (1992).
39. Miles, J., et. al., ``Assessment of Hazards Associated with
Pesticide Container Disposal and of Rinsing Procedures as a Means of
Enabling Disposal of Pesticide Containers in Sanitary Landfills,''
Journal of Environmental Science and Health, B, 305-315 (1983).
40. Minnesota Department of Agriculture. ``Bulk Pesticide Storage
Regulations,'' Chapter 1505.3010, Subpart 2.
41. Minnesota Department of Agriculture. ``Minnesota Superfund: A
Report on Use of the Minnesota Environmental Response, Compensation,
and Compliance Fund During Fiscal Year 1991'' (1991).
42. Morrison, P. Wisconsin Department of Agriculture, Trade and
Consumer Protection, ``Bulk Pesticide Facility Spills,'' Personal
communication to Mitchell Systems, Arlington, VA (1991).
43. Morrison, P. Wisconsin Department of Agriculture, Trade and
Consumer Protection, [Costs for cleanup of agrichemical dealerships in
Wisconsin], Personal communication to U.S. EPA summarized in November
12 memorandum by D. Howard (1991).
44. Morrison, P. Wisconsin Department of Agriculture, Trade and
Consumer Protection, [Explanation of certain portions of Wisconsin's
bulk pesticide rules], Personal communication to U.S. EPA (1991).
45. Morrison, P. and S. Kefer. Wisconsin Department of Agriculture,
Trade, and Consumer Protection and Wisconsin Department of Natural
Resources, ``Report on Wisconsin Pesticide Mixing and Loading Site
Study,'' (1991).
46. Myrick, C. National AgriChemical Retailers Association, [Brief
summarization of contamination characteristics associated with
agrichemical dealerships], Personal communication to U.S. EPA, July 21
(1992).
47. Novak, M. Utah Department of Environmental Quality, ``Survey of
Potential Soil and Groundwater Contamination at Licensed Pesticide
Dealers in Utah,'' (1991).
48. Ozkan, H. Ohio State University, ``Proper Rinsing and Disposal
of Pesticide Containers,'' February 14 (1991).
49. Palmer, L. and R. Hansen. Minnesota Department of Agriculture,
[Information on pesticide container collection programs], Personal
communication to members of the Minnesota Pesticide Container Advisory
Committee, September 30 (1991).
50. Paulson, D. Ciba-Geigy, ``Why Containment - Industry's
Perspective,'' Conference Proceedings, National Symposium on Pesticide
and Fertilizer Containment: Design and Management, MidWest Plan Service
(1992)
51. Peck, D. ``The Determination of Residue of Certain Pesticides
After Triple Rinsing,'' August (1985).
52. Read, D. Minnesota Department of Agriculture, ``Agricultural
Containment Failures,'' Personal communication to U. S. EPA. January 28
(1992).
53. Sausville, P. New York Department of Environmental
Conservation, ``The Pros and Cons of Concrete,'' Aboveground Tank
Update, July, pp. 13-14 (1991).
54. Stumpf, K. Ciba-Geigy, [Examples of point source contamination
involving pesticides], Personal communication to U.S. EPA, July 24
(1992).
55. Taylor, A. Illinois Environmental Protection Agency, ``Field
Investigation Reports of Seven Agrichemical Transportation Spills in
Illinois,'' (1990).
56. Taylor, A. Illinois Environmental Protection Agency, [Costs for
cleanup of agrichemical dealerships in Illinois], Personal
communication with U.S. EPA summarized in November 15 memorandum by D.
Howard (1991).
57. Taylor, A. Illinois Environmental Protection Agency,
``Testimony in Support of Regulatory Proposals Regarding Agrichemical
Storage and Handling Facilities,'' (1989).
58. Tennessee Valley Authority. ``Environmental Handbook for
Fertilizer and Agrichemical Dealers,'' editor: J. Parker, TVA/NFERC-91/
11. Circular Z-303. Muscle Shoals, AL (1991).
59. Tiernan, T. Wright State University, ``Assessment of Rinsing
Procedures for Removing Pesticides from Containers Used by Agricultural
Applicators,'' Quarterly Progress Report submitted to U.S. EPA,
February 1 (1990).
60. U.S. Coast Guard. National Response Center [selected spill data
with summary notes by U.S. EPA Office of Pesticide Programs] (1982
through 1991).
61. U.S EPA and Paper Shipping Sack Manufacturers Association,
``EPA/PSSMA Paper Bag Residue Study'' (1993).
62. U.S. EPA, Office of Compliance Monitoring. ``Amendment to the
July 11, 1977 Enforcement Policy Applicable to Bulk Shipment of
Pesticides,'' March 4 (1991).
63. U.S. EPA, Office of Compliance Monitoring. ``Enforcement Policy
Applicable to Bulk Shipment of Pesticides,'' July 11 (1977).
64. U.S. EPA, Office of Pesticide Programs. ``Label Improvement
Program -- Storage and Disposal Label Statements,'' Pesticide
Regulation Notice 83-3 (1983).
65. U.S. EPA, Office of Pesticide Programs. ``Pesticide Containers:
A Report to Congress,'' EPA publication number EPA 540/09-91-116, May
(1992).
66. U.S. EPA, Office of Pesticide Programs. ``Registrant
information on bulk-related spills,'' September 25 (1992).
67. U.S. EPA, Office of Pesticide Programs. ``Regulatory Impact
Analysis: Proposed Container Design and Residue Removal Regulations
Under the Federal Insecticide Fungicide and Rodenticide Act as Amended
1988,'' (1993).
68. U.S. EPA, Office of Pesticide Programs. ``Regulatory Impact
Analysis: Standards for Pesticide Containment Structures Under the
Federal Insecticide Fungicide and Rodenticide Act as Amended, 1988,''
(1993).
69. U.S. EPA, Office of Pesticide Programs. Research conducted by
Formulogics, Inc., ``Triple Rinsing of Containers, Rinsing Variables''
(1991).
70. U.S. EPA, Office of Pesticide Programs. ``State of the States:
Pesticide Storage, Disposal and Transportation,'' prepared for EPA by
Mitchell Systems Corporation, EPA publication number EPA 734-R-92-012
(1992).
71. U.S. EPA, Office of Pesticide Programs. ``Status of State
Regulations for Containment of Pesticide Bulk Containers,'' December 31
(1992).
72. U.S. EPA, Office of Pesticide Programs. ``Supporting Statement
for SF-83 Container Design and Residue Removal Regulations (40 CFR part
165),'' prepared for EPA by Mitchell Systems Corporation (1993).
73. U.S. EPA, Office of Pesticide Programs. ``Supporting Statement
for SF-83 Containment Structure Regulations (40 CFR part 165),''
prepared for EPA by Mitchell Systems Corporation (1993).
74. U.S. EPA, Office of Pesticide Programs. ``Trip Report to
Missouri,'' May 25 (1990).
75. U.S. EPA, Office of Research and Development. ``NPDES best
management practices guidance document,'' EPA publication number EPA-
600/9-79-045, December (1979).
76. United Nations. ``Recommendations on the Transport of Dangerous
Goods,'' 6th revised edition, New York (1989).
77. Vieira, K. Clorox, [Data from container rinsing tests conducted
by Chemical Specialties Manufacturers Association], Personal
communication to U.S. EPA, July 13 (1993).
78. Wisconsin Department of Agriculture, Trade, and Consumer
Protection. ``Background Report on Proposed Chapter Ag 163, Wisconsin
Administrative Code (pesticide bulk storage),'' (1985).
79. Wisconsin Department of Agriculture, Trade, and Consumer
Protection, Agricultural Resource Management Division. ``Explanations
and Interpretations of Ag 163, Wisconsin Administrative Code, Pesticide
Bulk Storage,'' (1989).
80. Zuelsdorff, N. Wisconsin Department of Agriculture, Trade, and
Consumer Protection, ``Pesticide Storage and Spill Containment; State
Initiatives,'' Proceedings, National Symposium on Pesticide and
Fertilizer Containment: Design and Management, MidWest Plan Service,
Iowa State University, Ames, IO (1991). Legislative/Administrative
References.
81. Leahy, P., 134 Congressional Record S13454, daily edition
September 28 (1988).
82. U.S. DOT. ``Performance-Oriented Packaging Standards; Changes
to Classification, Hazard Communication, Packaging and Handling
Requirements Based on UN Standards and Agency Initiative,'' 55 FR
52402, December 21 (1990).
83. U.S. DOT. ``Performance-Oriented Packaging Standards; Revisions
and Response to Petitions for Reconsideration,'' 56 FR 66124, December
20 (1991).
84. U.S. DOT. ``Intermediate Bulk Containers for Hazardous
Materials,'' 57 FR 36694, August 14 (1992).
85. U.S. EPA, Office of Air. ``Approval and Promulgation of State
Implementation Plans: Clean Air Act Amendments to Prevent Significant
Deterioration, 43 FR 26395, June 19 (1978).
86. U.S. EPA, Office of Compliance Monitoring. ``Interim
Determination of Adequacy of State Pesticide Residue Removal
Programs,'' 58 FR 43994, August 18 (1993).
87. U.S. EPA, Office of Compliance Monitoring. ``Pesticide
Management and Disposal,'' 58 FR 26856, May 5 (1993).
88. U.S. EPA, Office of Emergency and Remedial Response. ``Oil
Pollution Prevention; Non-transportation Related Onshore and Offshore
Facilities; Proposed Rules,'' 56 FR 54612, October 22 (1991).
89. U.S. EPA, Office of Pesticide Programs. ``Incentives for
Development and Registration of Reduced Risk Pesticides,'' 57 FR 32140,
July 20 (1992).
90. U.S. EPA, Office of Pesticide Programs. ``Notice of Voluntary
Packaging Standardization Scheme for Liquid Agricultural Pesticide
Formulations,'' 49 FR 212, October 31 (1984).
91. U.S. EPA, Office of Pesticide Programs. ``Reporting
Requirements for Risk/Benefit Information,'' 57 FR 44290, September 24
(1992).
92. U.S. EPA, Office of Pesticide Programs. ``Worker Protection
Standard,'' 57 FR 38102, August 21 (1992).
93. U.S. EPA, Office of Solid Waste. ``Hazardous Waste Management
System: General,'' 45 FR 33066, May 19 (1980).
94. U.S. EPA, Office of Solid Waste. ``Wood Preserving;
Identification and Listing of Hazardous Waste; Final Rule,'' 55 FR
50450, December 6 (1990).
95. U.S. EPA, Office of Solid Waste. ``Wood Preserving;
Identification and Listing of Hazardous Waste; Standards and Interim
Status Standards for Owners and Operators of Hazardous Waste Treatment,
Storage, and Disposal Facilities; Proposed Rulemaking,'' 56 FR 63848,
December 5 (1991).
96. U.S. EPA, Office of Underground Storage Tanks. ``Underground
Storage Tanks; Technical Requirements and State Program Approval; Final
Rules,'' 53 FR 37082, September 23 (1988).
97. U.S. EPA, Office of Water. ``Pesticide Chemicals Manufacturing
Effluent Limitations Guidelines and Standards,'' 57 FR 12560, April 10
(1992).
98. U.S. EPA. ``Pollution Prevention Strategy,'' 56 FR 7849,
February 26 (1991).
XIII. Regulatory Assessment Requirements
A. Executive Order 12291
Under Executive Order 12291, EPA must determine whether a rule is
``major'' by performing a Regulatory Impact Analysis (RIA). EPA has
determined that this is not a major rule because it is not likely to
have: (1) An annual effect on the economy of $100 million or more, (2)
a major increase in costs or prices for consumers, individual
industries, Federal, State, or local government agencies, or geographic
regions, or (3) significant adverse effects on competition, employment,
investment, productivity, innovation, or on the ability of United
States-based enterprises to compete with foreign-based enterprises in
domestic or export markets. Two RIAs -- one for the container and
labeling requirements and one for the containment requirements -- have
been developed and submitted to the Office of Management and Budget
(OMB) for review (Refs. 67 and 68). These documents are available for
public inspection at the address given at the beginning of this Federal
Register notice. In addition, this proposed rule was submitted to OMB
for review as required by E.O. 12291. Unless otherwise specified, the
discussion below represents a summary of the two RIAs together.
In developing the proposed regulations, EPA analyzed three
regulatory options in each of the RIAs. Regulatory Option 2 represents
EPA's proposed rule, Regulatory Option 1 represents a less stringent
option and Regulatory Option 3 represents a more stringent option.
The proposed rule would primarily affect registrants (formulators)
who package formulated pesticide products (formulating industry),
refillers/refilling establishments (generally agrichemical dealers) who
refill refillable containers (refilling industry), independent (for-
hire) aerial and ground applicators who apply agricultural pesticides
for compensation, and household and certain institutional end users who
will be affected by a triple rinse requirement for the first time.
Representative facilities were developed for each of the groups (except
end users) according to size and, for formulators, the pesticide market
segment served.
The costs of compliance were estimated on an individual facility
and a total industry basis, resulting in uneven cost streams
representing capital, initial, intermittent, compliance period and
operational and maintenance (annual) costs of compliance. Such
compliance streams were converted to an equivalent, constant-level cost
per year (an annualized cost) using an annual revenue requirement (ARR)
methodology. The annualized cost or ARR for each representative
facility was then compared to that facility's sales and profits before
tax to estimate the impacts of compliance. Any facility with an ARR to
sales ratio greater than 1.0 percent and an ARR to profits before tax
ratio of greater than 20 percent would be considered significantly
affected.
The total combined estimated costs of compliance for the proposed
rule would be $27.2 million to $37.7 million under Regulatory Option 1;
$38.7 million to $49.9 million under Regulatory Option 2 (EPA's
proposed option); and $102.6 million to $113.8 million under Regulatory
Option 3.
Under Regulatory Option 2 (the proposed rule), the total costs to
each of the industry sectors would be $19.9 million to $27.2 million
for the formulating industry, $11.2 million for the refilling industry,
$1.6 million for the independent (for-hire) applicator industry, and
$6.0 million to $9.9 million for end users. The formulating industry
would be most affected, bearing at least 50 percent of the total costs
of these proposed regulations.
The container RIA analyzes each of the regulatory options in two
scenarios, based on the number of container/formulation combinations
that are assumed would be tested for the nonrefillable container
residue removal standard. Scenario 1 assumes 50 percent of all rigid
container/dilutable formulation combinations would be tested for
residue removal, and Scenario 2 assumes 100 percent of all such
combinations would be tested.
In general, formulating facilities would not be significantly
affected under Scenario 1 of Regulatory Option 2. However, under
Scenario 2 of Regulatory Option 2, the following representative
formulating facilities would be affected significantly: small
formulating facilities in all of the pesticide sectors, one of the
model large agricultural facilities, and medium representative
industrial facilities.
Refilling facilities would not incur significant impacts as a
result of either the container standards or the containment standards.
Some independent (for-hire) aerial and ground applicators (less than 20
small and less than 80 medium aerial applicators) would be
significantly affected by the proposed rule. The number of small
applicators projected to be significantly affected as a result of the
costs of compliance does not represent a substantial number of small
aerial applicators.
EPA believes that rinsates and runoff from pads will not be
required to be treated as hazardous wastes. According to an Office of
Water survey, 98 percent of facilities surveyed are able to recycle
rinsates as reusable pesticide. The remainder of facilities will be
accounted for under water effluent guidelines. Thus EPA estimates that
the additional costs imposed by the proposed containment rule for
disposal of runoff and rinsates are zero.
The combined direct benefits of the rule have been estimated in a
range of $11.1 million to $16.0 million, with the midpoint at $13.6
million, as well as 1,650 to 2,250 acute illness incidents avoided
annually. The proposed container design/residue removal regulations are
expected to generate direct health and environmental benefits due to
fewer incidents of container failure, better ``usability'' of
containers, and less human and environmental exposure to insufficiently
rinsed containers. These benefits are expected to range from $4.1 to
$5.0 million and 1,650 to 2,250 acute illness incidents avoided
annually. The proposed containment regulations are expected to generate
direct environmental and health benefits due to fewer uncontrolled
releases of pesticides into the environment. These benefits are
evaluated in terms of avoided costs for remediating contaminated sites
and are estimated to range from $7.0 to $11.0 million annually.
In addition, indirect benefits are estimated based on the expected
shift from nonrefillable to refillable containers. All of these
indirect benefits ($106.1 million) are attributable to the shift from
nonrefillables to refillables. It is possible that all of this shift
could occur without this regulation over time. Therefore, it is assumed
that 25 to 75 percent of this shift is due to this rule. In this case,
total indirect benefits would be estimated at $26.5 to $79.6 million
annually. EPA solicits comments on the extent to which the indirect
benefits as characterized in the Container Design/Residue Removal RIA
properly reflect the percentage of indirect benefits that would be
attributable to the rule.
B. Regulatory Flexibility Act
This rule was reviewed under the provisions of section 3(a) of the
Regulatory Flexibility Act (RFA) [5 U.S.C. 605(b)]. The results of that
review have been incorporated into the regulatory impact analyses.
The RFA requires that regulatory agencies consider the potential
impacts of regulations on small businesses. A significant adverse
impact exists if one of the following criteria is met: (1) Annual
compliance costs increase total costs of production for small entities,
for the pertinent process or product being regulated, by more than five
percent, (2) compliance costs as a percent of sales for small entities
are at least ten percent higher than compliance costs as a percent of
sales for large entities, (3) capital costs of compliance represent a
significant portion of capital available to small entities, considering
internal cash flow plus external financial capabilities, and (4) the
requirements of the regulation are likely to result in closure of small
entities.
In developing these regulations, EPA has considered impacts on
small businesses by analyzing different stringency levels of
regulations (Regulatory Options 1, 2, and 3). Further, as indicated in
Unit XIII.A of this preamble, sensitivity analysis was evaluated on the
residue removal testing issue through the inclusion of scenarios 1 and
2 under each regulatory option in the container RIA. Scenario 1 assumes
50 percent of all rigid container/dilutable formulation combinations
would be tested for residue removal, and Scenario 2 assumes 100 percent
of all such combinations would be tested.
The analysis indicates small facilities would not be significantly
impacted under Regulatory Option 1 and Scenario 1 of Regulatory Option
2. Scenario 1 reflects EPA's anticipation that many container/
formulation combinations will not require residue removal testing. This
is because registrants (formulators) would acquire data that is
acceptable to EPA from other registrants and sources. If formulators
can demonstrate that a product shares the same formulation
characteristics as one that has met the residue removal standard and is
packaged in the same container that has been documented as meeting the
standard with that type of formulation, the burden on small formulators
is smaller. While it is not known just what percentage of container/
formulation combinations would ultimately be tested, analysis clearly
indicates that if all rigid/dilutable combinations were tested, small
formulating facilities in all of the pesticide sectors would likely
experience significant impacts under two regulatory options.
Neither the container RIA nor the containment RIA indicate that the
representative refillers/refilling establishments would be adversely
affected by compliance with the proposed regulations.
Some small for-hire applicators, primarily aerial application
businesses, (1) may experience increases in total costs of production
that are greater than five percent, (2) may have compliance costs at
least ten percent higher than those for large entities, and (3) may
face closure as a result of the proposed rule. However, the number of
small aerial applicators adversely impacted cannot be considered
``substantial,'' and such entities could avoid the costs of compliance
with the containment portion of the proposed rule by working from
smaller, nonbulk containers.
C. Paperwork Reduction Act
The information collection requirements contained in this proposed
rule have been submitted for approval to the Office of Management and
Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Two Information Collection Requests (ICRs) -- one for the container and
labeling requirements and one for the containment requirements -- have
been prepared by EPA (Refs. 72 and 73) and copies may be obtained from
Sandy Farmer, Information Policy Branch (2136), EPA, 401 M St., SW.,
Washington, DC 20460 or by calling (202) 260-2740.
According to the container ICR, the total annual burden to
respondents and EPA is estimated to be 573,425 hours. In addition,
total annual costs to respondents and EPA are estimated to be
$16,869,059. Public respondent burden for this collection of
information (for the container standards) is estimated to average 93.90
hours per response, including the time for: reviewing instructions;
planning and coordinating compliance activities; creating new and
gathering existing data; compiling and reviewing data; completing
paperwork and submitting the required data to EPA; and maintaining data
in company files.
According to the containment ICR, the total annual burden to
industry and EPA is estimated to be 15,519 hours. Total annual costs to
respondents and EPA are estimated to be $473,263. Public respondent
burden for this collection of information (for the containment
standards) is estimated to average 2.72 hours per response, including
the time for: reviewing instructions; planning and coordinating
compliance activities; creating new and gathering existing data;
compiling and reviewing data; completing paperwork; and maintaining
data in company files.
Send comments regarding these burden estimates or any other aspect
of these collections of information, including suggestions for reducing
the burden, to Chief, Information Policy Branch, 2136, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, DC. 20460;
and to the Office of Information and Regulatory Affairs, Office of
Management and Budget, Washington, D.C. 20503, Attn: Desk Officer for
EPA. The final rule will respond to any OMB or public comments on the
information collection contained in this proposal.
List of Subjects
40 CFR Part 156
Environmental protection, Labeling, Pesticides and pests.
40 CFR Part 165
Environmental protection, Packaging and containers, Pesticides and
pests, Waste treatment and disposal.
Dated: February 2, 1994.
Carol M. Browner,
Administrator.
Therefore, it is proposed that 40 CFR chapter I, subchapter E, be
amended as follows:
PART 156--[AMENDED]
1. In part 156:
a. The authority citation would continue to read as follows:
Authority: 7 U.S.C. 136-136y.
b. In Sec. 156.10 by adding paragraph (d)(7), and by revising
paragraphs (f) and (i)(2)(ix) to read as follows:
Sec. 156.10 Labeling requirements.
* * * * *
(d) * * *
(7) For pesticide packaged in a refillable container, an
appropriately sized area on the label shall be left blank to allow the
net weight or measure of content to be marked in by the refilling
establishment prior to distribution or sale of the pesticide.
* * * * *
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase ``EPA Est.'',
of the final establishment at which the product was produced may appear
in any suitable location on the label or immediate container. It must
appear on the wrapper or outside container of the package if the EPA
establishment registration number on the immediate container cannot be
clearly read through such wrapper or container. For pesticide packaged
in a refillable container, an appropriately sized area on the label
shall be left blank after the phrase ``EPA Est.'' to allow the EPA
establishment registration number to be marked in by the refilling
establishment prior to distribution or sale of the pesticide.
* * * * *
(i) * * *
(2) * * *
(ix) Specific directions concerning the storage, residue removal
and disposal of the pesticide and its container, in accordance with
Sec. Sec. 156.140 and 156.144 and part 165 of this chapter and other
Agency instructions. These instructions shall be grouped and appear
under the heading, ``Storage and Disposal.''
* * * * *
c. By adding subpart H entitled ``Container Labeling,'' consisting
of Sec. Sec. 156.140 and 156.144, to read as follows:
Subpart H - Container Labeling
Sec.
156.140 Identification of container types.
156.144 Residue removal instructions.
Subpart H-- Container Labeling
Sec. 156.140 Identification of container types.
The following statement(s) shall be placed on the label or
container. The information may be located on any part of the container
except the closure. If the statements are placed on the container, they
shall be permanently marked on the container.
(a) Nonrefillable container -- (1) Statement identifying a
nonrefillable container. The following statement is required:
Nonrefillable container. Do not reuse or refill this container.
Offer for recycling if possible.
(2) Batch code. A lot number, or other code used by the registrant
or producer to identify the batch of the pesticide product which is
distributed and sold.
(b) Refillable container. The following statement is required:
Refill this container only with pesticide. Do not reuse this
container for any other purpose.
Sec. 156.144 Residue removal instructions.
(a) General. Except as provided by paragraph (b) of this section,
each pesticide product must bear on the label instructions pertaining
to the removal of pesticide residues from the container prior to
container disposal that are specified in this section. The residue
removal statements and instructions are required for both nonrefillable
and refillable containers.
(b) Modification. EPA may, on its own initiative or based on data
submitted by any person, modify or waive the requirements of this
section, or permit or require alternative labeling statements.
(c) Placement and subheading of residue removal statements -- (1)
Placement. All residue removal statements and instructions shall be
placed under the `Directions for Use' portion of the label, under the
heading ``Storage and Disposal.''
(2) Subheading. All residue removal statements and instructions
shall be grouped together under the subheading `Container Cleaning'.
(d) Residue removal statements for nonrefillable containers. The
label of each pesticide packaged in a nonrefillable container shall
bear the following residue removal statements and instructions as
appropriate.
(1) Rigid container containing a liquid or dry dilutable pesticide.
The statement in paragraph (d)(1)(i) of this section and the
instructions of either paragraph (d)(1)(ii) or (d)(1)(iii) of this
section, as appropriate, shall appear on the label of liquid or dry
dilutable pesticides packaged in rigid containers.
(i) Timing of the residue removal procedure. (A) The following
statement must immediately precede the instructions required in
paragraph (d)(1)(ii) or (d)(1)(iii) of this section:
Clean container immediately after emptying.
(B) When both triple and pressure rinse procedures will be allowed,
the statement of paragraph (d)(1)(i)(A) of this section may be
substituted with the following statement:
Triple rinse or pressure rinse container immediately after
emptying.
(C) When only a triple rinse container cleaning procedure will be
required, the statement of paragraph (d)(1)(i)(A) of this section may
be substituted with the following statement:
Triple rinse container immediately after emptying.
(D) When only a pressure rinse container cleaning procedure will be
required, the statement of paragraph (d)(1)(i)(A) of this section may
be substituted with the following statement:
Pressure rinse container immediately after emptying.
(ii) Residue removal instructions for dilutable liquid pesticides.
One of the following instructions shall appear on the label of
dilutable liquid pesticide products, but both instructions may be used.
(A) Triple rinse. For triple rinse, use the following label
instruction:
Triple Rinse as follows: Empty the remaining contents of this
container into application equipment, and drain for 30 seconds after
the flow begins to drip. Fill the container 1/4 full with water and
recap. Agitate for 30 seconds. Pour rinsate into application
equipment or store rinsate for later use or disposal. Drain for 30
seconds after the flow begins to drip. Repeat this procedure two
more times.
(B) Pressure rinse. For pressure rinse, use the following label
instruction:
Pressure rinse as follows: Empty the remaining contents of this
container into application equipment, and continue to drain for 30
seconds after the flow begins to drip. Hold container over
application equipment or collect rinsate for later use or disposal.
Insert pressure rinsing nozzle, and rinse at 40 PSI for 30 seconds.
Drain for 30 seconds after the flow begins to drip.
(iii) Residue removal instructions for dilutable dry pesticides.
One of the following instructions shall appear on the label of
dilutable dry pesticide products, but both instructions may be used.
(A) Triple rinse. For triple rinse, use the following label
instruction:
Triple Rinse as follows: Empty the remaining contents of this
container into application equipment. Fill the container 1/4 full
with water and recap. Agitate for 30 seconds. Pour rinsate into
application equipment or store rinsate for later use or disposal.
Drain for 30 seconds after the flow begins to drip. Repeat this
procedure two more times.
(B) Pressure rinse. For pressure rinse, use the following label
instruction:
Pressure rinse as follows: Empty the remaining contents of this
container into application equipment. Hold container over
application equipment or collect rinsate for later use or disposal.
Insert pressure rinsing nozzle, and rinse at 40 PSI for 30 seconds.
Drain for 30 seconds after the flow begins to drip.
(iv) Non-water diluent. (A) A registrant who wishes to require
users to clean a container with a diluent other than water (e.g.,
solvents) must submit to the Agency a written request to modify the
residue removal instructions of paragraph (d)(1)(ii) or (iii) of this
section, as applicable. The registrant may not distribute or sell the
pesticide until the Agency approves the request in writing.
(B) The registrant must indicate why a non-water diluent is
necessary for efficient residue removal, and must propose residue
removal instructions that are appropriate for the characteristics and
formulation of the pesticide product and non-water diluent. The
proposed residue removal instructions must identify the diluent. If the
Directions for Use permit the application of a mixture of the pesticide
and the non-water diluent, the instructions may allow the rinsate to be
added to the application equipment. If the Directions for Use do not
identify the nonwater diluent as an allowable addition to the
pesticide, the instructions must require collection and storage of the
rinsate in a rinsate collection system.
(C) The Agency may approve the request if the Agency finds that the
proposed instructions are necessary and appropriate.
(2) [Reserved]
(e) Residue removal statements for refillable containers. The label
of pesticide packaged in refillable containers shall bear the following
statements and instructions.
(1) Timing of the residue removal procedure. (i) The following
statement must immediately precede the instructions required in
paragraph (e)(2) of this section:
Clean container before disposal.
(ii) The statement in paragraph (e)(1)(i) of this section may be
substituted with the following statement or another phrase that more
precisely describes the cleaning procedure:
Pressure rinse container before disposal.
(2) Residue removal instructions prior to container disposal. (i) A
statement giving instructions on cleaning each refillable container
prior to disposal is required. Instructions shall be given for all
pesticide products, including those that do not require dilution prior
to application.
(ii) The statement on residue removal instructions shall be
appropriate for the characteristics and formulation of the pesticide
product and must be adequate to protect human health and the
environment.
(iii) Subject to meeting the standard in paragraph (e)(2)(ii) of
this section, the statement on residue removal instructions could
include any one of the following:
(A) The refilling residue removal procedure developed by the
registrant for the pesticide product.
(B) Standard industry practices for pesticide refillable
containers.
(C) For pesticides that require dilution prior to application, the
following statement:
Empty the remaining contents from this container. Fill the
container about 10 percent full with water. Agitate vigorously or
recirculate water with the pump for 2 minutes. Pour or pump rinsate
into application equipment or rinsate collection system. Repeat this
rinsing procedure two more times.
(D) Any other statement the registrant considers appropriate.
(f) Compliance date. As of [2 years after the date of publication
of the final rule in the Federal Register] the labels of all pesticide
products distributed or sold by the registrant in nonrefillable and
refillable containers shall be in compliance with the requirements of
this part.
PART 165-- [AMENDED]
2. In part 165:
a. By revising the authority citation to read as follows:
Authority: 7 U.S.C. 136a, 136f, 136m, 136q and 136w.
Sec. 165.11 [Removed]
b. By removing Sec. 165.11
Sec. Sec. 165.1-165.10 [Redesignated]
c. By redesignating Sec. Sec. 165.1 through 165.10 as set forth in
the table below, and by transferring all of the newly redesignated
sections to subpart A of part 165:
Redesignation Table
------------------------------------------------------------------------
Old New
------------------------------------------------------------------------
165.1.......................................................... 165.3
165.2.......................................................... 165.1
165.3.......................................................... 165.5
165.4.......................................................... 165.7
165.5.......................................................... 165.8
165.6.......................................................... 165.10
165.7.......................................................... 165.12
165.8.......................................................... 165.11
165.9.......................................................... 165.14
165.10......................................................... 165.16
------------------------------------------------------------------------
SUBPARTS B-D [Reserved]
d. By removing and reserving the designations for subparts B
through D.
e. By revising newly redesignated Sec. 165.1 to read as follows:
Sec. 165.1 Authorization and scope.
(a) The regulations and recommended procedures in this part address
management of excess pesticides, management of pesticide containers,
and acceptance by the Administrator of pesticides for safe disposal.
The following provisions apply only to subpart A of this part:
(1) Regulations for acceptance for safe disposal of pesticides
canceled under section 6(c) and recommended procedures for disposal or
storage of pesticides, pesticide containers, and pesticide-related
wastes are those which the Administrator judges as necessary, with an
adequate margin of safety, to protect public health and the
environment. Such procedures are subject to addition and revision as
the Administrator deems necessary.
(2) The recommended procedures for the disposal of pesticides and
pesticide containers apply to all pesticides, pesticide-related wastes
(and their containers) including those which are or may in the future
be registered for general use or restricted use, or covered under an
experimental use permit, except those single containers discussed in
paragraph (a)(4) of this section. These disposal procedures are
mandatory only for the Agency in carrying out its pesticide and
container disposal operations.
(3) The recommended procedures and criteria for the storage of
pesticides and pesticide containers apply to all pesticides and excess
pesticides and to used empty containers and containers which contain
pesticides. These procedures and criteria apply to all sites and
facilities where pesticides that are classed as highly toxic or
moderately toxic, and bear the signal words DANGER, POISON, or WARNING,
or the skull and crossbones symbol, on the label are stored. Pesticides
covered by an experimental use permit should also be stored in
accordance with these procedures. These procedures are mandatory only
for the Agency in carrying out its pesticide and container storage
operations. Temporary storage by the user of the quantity of the
pesticide needed for a single application may be undertaken in isolated
areas in accordance with the procedures and criteria given in
Sec. 165.16(a).
(4) Recommended pesticide and pesticide container disposal
procedures shall not apply to containers of pesticides registered for
use in the home and garden if securely wrapped in several layers of
paper and disposed of singly during routine municipal solid waste
disposal, nor to containers of pesticides used on farms and ranches
where disposal by an open-field burial of single containers is
undertaken with due regard to the protection of surface and sub-surface
waters.
(b) As a general guideline, the owner of excess pesticides should
first exhaust the two following avenues before undertaking final
disposal:
(1) Use for the purpose originally intended, at the prescribed
dosage rates, providing these are currently legal under all Federal,
State, and local laws and regulations.
(2) Return to the manufacturer or distributor for potential re-
labeling, recovery of resources, or reprocessing into other materials.
Transportation must be in accordance with all currently applicable U.S.
Department of Transportation regulations.
Sec. 165.3 [Amended]
f. Newly designated Sec. 165.3 is amended by removing paragraphs
(a), (d), (e), (g), (h), (i), (l), (p), (s), (u), and (y).
g. Section 165.3 is further amended by removing the remaining
paragraph designations, arranging the remaining definitions in
alphabetical order, revising the definitions for ``Container,'' and
``Triple rinse,'' and by adding alphabetically the other terms and
definitions set forth below to read as follows:
Sec. 165.3 Definitions.
* * * * *
Act means the Federal Insecticide, Fungicide and Rodenticide Act.
* * * * *
Agricultural pesticide means any pesticide product labeled for use
in a nursery or greenhouse or for use in the production of any
agricultural commodity, including any plant, plant part, animal, or
animal product produced by persons (including farmers, ranchers,
vineyardists, plant propagators, Christmas tree growers,
aquaculturalists, horticulturists, orchardists, foresters, or other
comparable persons) primarily for sale, consumption, propagation or
other use by man or animals.
Appurtenances means equipment or devices which are used for the
purpose of transferring pesticides from a bulk container or to any
refillable container, including but not limited to, hoses, fittings,
plumbing, valves, gauges, pumps and metering devices.
Container means any package, can, bottle, bag, barrel, drum, tank,
or other containing-device (excluding spray applicator tanks) used to
enclose a pesticide or pesticide-related waste. Containers that are
used to sell or distribute a pesticide product and that are also spray
applicator tanks are considered to be containers for the purposes of
this part.
Containment pad means any structure that is designed and
constructed to intercept and contain pesticides, rinsates, and
equipment wash water and prevent them from running off or leaching from
a pesticide dispensing area.
Containment structure means either a secondary containment unit or
a containment pad.
Design type means the characteristics of design and construction of
a container that render it distinguishable from other containers. A
container design type is defined by the following parameters:
structural design, size, material of construction, wall thickness,
manner of construction, and, for refillable containers as appropriate,
pump fittings. A change in any one of these parameters constitutes a
different design type, except that a design type may include containers
with various surface treatments and containers that differ only in
their lesser design height.
Dry bulk container means a refillable container designed and
constructed to hold only dry pesticide formulations with the capacity
to hold undivided quantities of greater than 2,000 kilograms (4,409
pounds).
Dry minibulk container means a refillable container designed and
constructed to hold only dry pesticide formulations with the capacity
to hold undivided quantities of less than or equal to 2,000 kilograms
(4,409 pounds).
Dry pesticide means any pesticide that is in solid form and that
has not been combined with liquids; this includes formulations such as
dusts, wettable powders, dry flowable powders, granules, and dry baits.
* * * * *
Establishment means any site where a pesticidal product, active
ingredient, or device is produced, regardless of whether such site is
independently owned or operated, and regardless of whether such site is
domestic and producing a pesticidal product for export only, or whether
the site is foreign and producing any pesticidal product for import
into the United States.
* * * * *
Liquid bulk container means a refillable container designed and
constructed to hold liquid pesticide formulations with the capacity to
hold undivided quantities of greater than 3,000 liters (793 gallons).
Liquid minibulk container means a refillable container designed and
constructed to hold liquid pesticide formulations with the capacity to
hold undivided quantities of less than or equal to 3,000 liters (793
gallons).
Nonrefillable container means a container that is not a refillable
container and that is designed and constructed for one time containment
of a pesticide.
* * * * *
One-way valve means a valve that is designed and constructed to
allow the withdrawal of material from, but not the introduction of
material into, a container.
* * * * *
Operator means any person in control of, or having responsibility
for, the daily operation of a facility at which a containment structure
is required.
Owner means any person who owns a facility at which a containment
structure is required.
Pesticide dispensing area means an area in which pesticide is
transferred out of or into a container.
* * * * *
Pressure rinse means the flushing of the container to remove
pesticide residue by using a pressure method.
Produce means to manufacture, prepare, propagate, compound, or
process any pesticide, including any pesticide produced pursuant the
section 5 of the Act, and any active ingredient or device, or to
package, repackage, label, relabel, or otherwise change the container
of any pesticide or device.
Producer means any person, as defined by the Act, who produces any
pesticide, active ingredient, or device (including packaging,
repackaging, labeling and relabeling).
Refillable container means a container that is intended to be
filled with pesticide more than once.
Refiller means a person who engages in the activity of repackaging
pesticide product into refillable containers. This could include a
registrant, a person operating under contract to a registrant, or a
person operating under written authorization from a registrant.
Refilling establishment means an establishment where the activity
of repackaging pesticide product into refillable containers occurs.
* * * * *
Repackage means, for the purposes of this part, to transfer a
pesticide formulation from one container to another without a change in
the composition of the formulation or the labeling content, for sale or
distribution.
* * * * *
Secondary containment unit means any structure, including rigid
diking, that is designed and constructed to intercept and contain
pesticide spills and leaks and prevent runoff or leaching from
stationary bulk containers.
* * * * *
Stationary bulk container means a liquid bulk container or a dry
bulk container that is fixed at a single facility or establishment or,
if not fixed, remains at the facility or establishment for at least 14
consecutive days, during all of which time the container holds
pesticide.
Tamper-evident device means a device which can be visually
inspected to determine if a container has been opened.
Transport vehicle means a cargo-carrying vehicle such as an
automobile, van, tractor, truck, semitrailer, tank car or rail car used
for the transportation of cargo by any mode.
Triple rinse means the flushing of the container three times to
remove pesticide residue by using a non-pressurized method.
* * * * *
25-year, 24-hour rainfall event means a rainfall event with a
probable recurrence interval of once in 25 years, as defined by the
National Weather Service in Technical Paper Number 40, ``Rainfall
Frequency Atlas of the United States'', May, 1961, and subsequent
amendments, or equivalent regional or State rainfall probability
information developed therefrom. Technical Paper Number 40 may be
obtained from the National Climatic Data Center, Federal Building,
Ashville, NC 28801-2696; telephone 704-259-0682.
* * * * * *
h. By adding and reserving subpart E and adding new subparts F, G,
and H to part 165 to read as follows:
Subpart F-- Nonrefillable Container Standards: Container Design and
Residue Removal
Sec.
165.100 Scope and applicability.
165.102 Container design standards.
165.104 Residue removal standards.
165.106 Rigid/dilutable residue removal methodology.
165.111 Certification.
165.114 Recordkeeping and inspections.
165.117 Compliance dates.
165.119 Waiver from standardized closures requiring Agency
approval.
Subpart G -- Refillable Container Standards: Container Design and
Residue Removal
165.120 Scope.
165.122 Applicability.
165.124 Container design standards.
165.125 Minibulk container drop test methodology.
165.126 Certification.
165.128 Container design recordkeeping and inspection.
165.129 Transfer of registered pesticide products into refillable
containers.
165.130 Registrant responsibilities concerning refilling
activities.
165.132 Registrant recordkeeping and inspections.
165.134 Refiller responsibilities and procedures.
165.136 Refiller recordkeeping and inspections.
165.139 Compliance dates.
Subpart H -- Standards for Pesticide Containment Structures
165.140 Scope and purpose.
165.141 Applicability to facilities and persons.
165.142 Applicability to stationary bulk containers and pesticide
dispensing areas.
165.144 Existing and new containment structures.
165.146 Containment structures: general requirements.
165.148 Specific requirements for containment of stationary liquid
bulk containers.
165.150 Specific containment requirements for stationary dry bulk
containers.
165.152 Specific containment requirements for pesticide dispensing
areas.
165.153 Integrated systems.
165.156 Compliance dates.
165.157 Recordkeeping requirements and inspections.
Subpart F -- Nonrefillable Container Standards: Container Design
and Residue Removal
Sec. 165.100 Scope and applicability.
This subpart establishes design and construction standards and
requirements for nonrefillable containers used for the sale or
distribution of pesticide products. This subpart applies to
registrants. This subpart does not apply to containers that contain
manufacturing use products, as defined in Sec. 158.153(h) of this
chapter.
Sec. 165.102 Container design standards.
(a) General. (1) A registrant shall not sell or distribute a
pesticide product in a nonrefillable container unless the nonrefillable
container meets the standards of this section.
(2) Information on container failures or other incidents involving
pesticide containers that may result in releases of pesticide may be
reportable under section 6(a)(2) of the Act.
(3) Compliance with part 165 container design requirements does not
exempt registrants from compliance with the Department of
Transportation's (DOT) Hazardous Materials Regulations at 49 CFR parts
171 through 180, if DOT's requirements are applicable.
(b) Container integrity. Each nonrefillable container design type
shall prevent leakage under conditions of normal storage, distribution,
sale, and use, and shall be compatible with the pesticide formulation
it contains.
(c) Permanent marking. Each nonrefillable container shall be
permanently marked with the information listed in this paragraph. The
information shall be visibly located on the outside part of the
container except on a closure. Placement on the label or labeling is
not sufficient unless the label is an integral, permanent part of or
permanently stamped on the container. The information shall include:
(1) The EPA registration number of the pesticide.
(2) The name, symbol, or code of the material(s) from which the
container is constructed.
(d) Container dispensing capability. Each nonrefillable container
design type for liquid pesticide shall:
(1) Allow the contents of the nonrefillable container to pour in a
continuous, coherent stream.
(2) Eliminate dripping so that no pesticide is visible on the
outside of the nonrefillable container during the use of the container
or after the closure (cap) is removed and the container is emptied.
(3) Reclose securely so as not to allow the escape of any pesticide
or rinsate during storage or the triple rinse residue removal
procedure.
(e) Standardized closures -- (1) Requirement. A liquid agricultural
pesticide that is packaged in a rigid nonrefillable container greater
than or equal to 3.0 liters (0.79 gallons) shall be packaged in a
container having one of the following standardized closures:
(i) Bung, 50.0 millimeters (2.0 inches), external threading, 11.5
threads per 25.4 millimeters (11.5 threads per inch) National Pipe
Threading (NPT) standard.
(ii) Bung, 50.0 millimeters (2.0 inches), external threading, 5
threads per 25.4 millimeters (5 threads per inch).
(iii) Screw cap, 63.0 millimeters (2.5 inches), at least one thread
revolution at 6 threads per 25.4 millimeters (6 threads per inch).
(iv) Screw cap, 38.0 millimeters (1.5 inches), at least one thread
revolution at 6 threads per 25.4 millimeters (6 threads per inch). Cap
to fit on separate rigid spout or on flexible pull-out plastic spout
designed to crimp-on container with a 63.0 millimeter (2.5 inch)
orifice.
(2) Non-standardized closure. A registrant may request approval to
use a non-standardized closure by following the procedures established
in Sec. 165.119.
(3) Exemptions. Aerosol and pressurized containers are exempt from
the requirements for standardized closures in this paragraph.
Sec. 165.104 Residue removal standards.
(a) Residue removal standard. Each nonrefillable container design
type and pesticide formulation combination shall meet the applicable
residue removal standard of this section.
(b) Standard for rigid containers with dilutable pesticide -- (1)
Requirement. If the nonrefillable container is rigid and the pesticide
product labeling allows or requires the pesticide product to be mixed
with a liquid diluent prior to application (dilutable), then the
registrant shall demonstrate for each container/formulation combination
that at least 99.9999 percent removal of each active ingredient is
achieved using the rigid/dilutable residue removal methodology of
Sec. 165.106. Percent removal represents the percent of the original
concentration of the active ingredient when compared to the
concentration of that active ingredient in the fourth rinse.
(2) Good Laboratory Practice Standards. The testing shall be
conducted in accordance with the Good Laboratory Practice Standards in
part 160 of this chapter.
(c) Modification. The Agency may, on its own initiative or based on
data submitted by any person, modify or waive the requirements of this
section.
Sec. 165.106 Rigid/dilutable residue removal methodology.
(a) General. The rigid/dilutable residue removal methodology of
paragraphs (b), (c) and (d) of this section shall be adhered to in
demonstrating compliance with the residue removal standard of 99.9999
percent removal of Sec. 165.104.
(b) General testing methodology. The methodology used in conducting
testing under paragraph (c) of this section shall adhere to the
following:
(1) The number of containers tested shall be adequate to meet the
residue standard specified in Sec. 165.104(b) in a statistically valid
manner, with the minimum requirements being as follows: A minimum of 19
containers shall be selected at random and tested, with at least a 95
percent confidence that at least 85 percent of containers tested will
meet the minimum residue removal standard.
(2) The temperature of the distilled water used to rinse the
containers in each rinse cycle shall be 23 3 degrees
Celsius (73 5 degrees Fahrenheit).
(3) The volume of distilled rinse water used in each rinse cycle
shall be 25 1 percent of the rated volume of the
container. The volume of distilled rinse water added to the container
in each rinse cycle shall be recorded.
(c) Test methods. The testing shall be conducted by following the
steps in paragraphs (c)(1) through (c)(4) of this section in sequence.
(1) Step 1. The container shall be filled to its rated capacity
with the pesticide formulation, capped and then shaken vigorously in
order to expose the entire inside of the container to the pesticide.
(2) Step 2. The cap shall be removed from the container. The
contents of the container shall be emptied by inverting it over a
suitable collection vessel and, if a liquid formulation, allowed to
drain for 30 seconds after the flow begins to drip. The container shall
be recapped to prevent the residue from evaporating. The rinse cycle of
paragraph (c)(3) of this section shall begin within 30 minutes.
(3) Step 3. Distilled rinse water, according to paragraphs (b)(2)
and (b)(3) of this section, shall be added to the drained container.
The cap shall be placed back on the container and the container shall
be shaken vigorously for 30 seconds. The cap shall be removed from the
container. The container shall be inverted over a clean collection
vessel and allowed to drain for 30 seconds after the flow begins to
drip.
(4) Step 4. The rinse cycle of paragraph (c)(3) of this section
shall be repeated three more times, i.e., conducted a total of four
times (four rinse cycles). The rinsate from the fourth rinse cycle
shall be analyzed following the methods in paragraph (d) of this
section.
(d) Analysis methods. The analysis of the test shall adhere to the
following steps:
(1) The rinsate from the fourth rinse cycle shall be analyzed for
each active ingredient using any validated analytical procedure
suitable for the analysis of the active ingredient in water.
(2) The temperature of the fourth rinsate when tested shall be 23
3 degrees Celsius (73 5 degrees Fahrenheit).
(3) The rinsate ratio and percent removal shall be calculated as
follows below, and both calculations shall be recorded.
(i) The rinsate ratio is the ratio of the concentration of active
ingredient found in the fourth rinse to the formulation's original
active ingredient concentration. This rinsate ratio quantity shall be
calculated as follows:
TP11FE94.011
(ii) The percent removal compares the active ingredient
concentrations in the fourth rinsate and the original formulation,
measuring how much the concentration of active ingredient found in the
fourth rinsate has been reduced from the formulation's original active
ingredient concentration. The percent removal shall be calculated as
follows:
percent removal = [1.0 - A] X 100.0.
Sec. 165.111 Certification.
(a) Certification. The registrant shall certify to the Agency that
all nonrefillable container(s) used for each registered pesticide
product meet the standards of Sec. 165.102 and Sec. 165.104.
(b) Submission of certification. Certification shall be submitted
with each application for a new registration. For pesticide products
registered as of [date of publication of the final rule in the Federal
Register], a certification shall be submitted according to the
compliance schedule in Sec. 165.117. The certification shall be
submitted to the address given in Sec. 165.119(a)(2).
(c) Contents of certification. The certification shall contain the
following information:
(1) The name and EPA registration number of the pesticide product
to which the certification applies; the registrant's name and address;
the date; and the name, title, signature, and telephone number of the
company official authorized to make the certification.
(2) A written statement that the nonrefillable container(s) in
which the pesticide product is distributed or sold meet the standards
of Sec. 165.102 and Sec. 165.104. The statement, ``I certify that the
nonrefillable container(s) that are used for the distribution or sale
of this pesticide product meet the standards of 40 CFR 165.102 and
165.104.'' will satisfy this requirement.
Sec. 165.114 Recordkeeping and inspections.
The registrant shall maintain the records required by this section
for as long as the nonrefillable container design type is used with the
registered pesticide product, and for 3 years thereafter. The
registrant, upon request of any officer or employee of the Agency or of
any State or political subdivision duly designated by the Agency, shall
furnish and make available for inspection and copying the records
specified in paragraphs (a) through (e) of this section.
(a) General information. The registrant shall keep the name and EPA
registration number of the pesticide product, and description of the
design type of the nonrefillable container(s) in which the pesticide
product is distributed or sold.
(b) Certification. The registrant shall keep a copy of the
certification described in Sec. 165.111 for each pesticide product.
(c) Container dispensing capability. The registrant shall keep at
least one of the following records pertaining to the requirements of
Sec. 165.102(d) for each nonrefillable container design type for each
pesticide product:
(1) Test data or documentation demonstrating that the nonrefillable
container with the pesticide product meets the standard in
Sec. 165.102(d).
(2) Test data or documentation showing a different nonrefillable
container with the same or a different pesticide product meets the
standard in Sec. 165.102(d), together with a written explanation of why
such data or documentation demonstrates that the container meets the
standard in Sec. 165.102(d).
(d) Standardized closures. The registrant shall keep at least one
of the following records pertaining to the requirements of
Sec. 165.102(e) for each nonrefillable container design type for each
pesticide product:
(1) A letter or literature from the container supplier.
(2) A specification in the contract between the registrant or
applicant and the container supplier.
(3) A copy of the Agency approval of any non-standardized closure.
(e) Residue removal. (1) The registrant shall keep at least one of
the following records pertaining to the residue removal standard of
Sec. 165.104 for each nonrefillable container design type for each
pesticide product:
(i) Test data showing that the container design type and pesticide
formulation combination meets the standard in Sec. 165.104 and that
residue removal methodology in Sec. 165.106 was followed.
(ii) Test data showing a different nonrefillable container with the
same or a different pesticide formulation meets the standard in
Sec. 165.104, together with a written explanation of why such data
demonstrates that the container design type and pesticide formulation
combination meets the standard in Sec. 165.104.
(iii) A letter from the facility that conducted the test describing
the specific test type, a description of the container design type, a
description of the pesticide formulation, the test results, and the
location of the original data.
(2) The registrant shall keep with the residue removal records a
statement of compliance or noncompliance with respect to Good
Laboratory Practice Standards as described at Sec. 160.12 of this
chapter.
(3) The Agency reserves the right to require, on a case by case
basis, submission of the residue removal test data for any pesticide
product registered or proposed for registration.
Sec. 165.117 Compliance dates.
(a) As of [2 years after the date of publication of the final rule
in the Federal Register], all pesticide products distributed or sold by
the registrant in nonrefillable containers shall be distributed or sold
in compliance with this subpart.
(b) As of [5 years after the date of publication of the final rule
in the Federal Register], all pesticide products distributed or sold by
persons other than the registrant in nonrefillable containers shall be
distributed or sold in compliance with this subpart.
(c) Certifications for pesticide products registered as of [date of
publication of the final rule in the Federal Register] shall be
submitted to and received by the Agency by [2 years after the date of
publication of the final rule in the Federal Register].
Sec. 165.119 Waiver from standardized closures requiring Agency
approval.
(a) General. Requests for a waiver from the standardized closure
requirement of Sec. 165.102(e) shall be submitted in writing to the
Agency.
(1) The Agency must have approved in writing the request for the
waiver before the registrant is allowed to distribute or sell the
pesticide product in the nonconforming nonrefillable container.
(2) Requests shall be submitted to the following address: U.S.
Environmental Protection Agency, Office of Pesticide Programs,
Registration Division (7505C), 401 M St., SW., Washington, DC 20460.
(3) Requests shall be accompanied by two copies of the following
information, which may be part of an application for registration or
amended registration:
(i) The name and address of the registrant; the date; and the name,
title, signature, and phone number of the company official making the
request.
(ii) The name and EPA registration number of the pesticide product
for which the waiver is requested.
(iii) A statement indicating that the request is for a waiver from
the standardized closure requirement of Sec. 165.102(e).
(iv) A description of the design type of the nonrefillable
container for which the waiver is requested.
(v) Documentation or justification to demonstrate that the non-
standardized closure meets one of the criteria in paragraph (b) of this
section.
(b) Approval of waiver. The Agency may approve a nonstandardized
closure when the Agency is satisfied that:
(1) The non-standardized closure is necessary for the proper
mixing, loading, or application of the pesticide product.
(2) The non-standardized closure will offer exposure protection to
handlers during mixing and loading that is the same or greater than
that provided by the standardized closures.
Subpart G -- Refillable Container Standards: Container Design and
Residue Removal
Sec. 165.120 Scope.
(a) Container design. This subpart sets forth design and
construction standards and requirements for refillable containers used
for the distribution or sale of pesticide products.
(b) Refilling requirements. This subpart establishes the standards
and requirements for repackaging pesticide products into refillable
containers.
Sec. 165.122 Applicability.
(a) The requirements of this subpart apply as follows:
(1) Registrants who distribute or sell pesticide products in
refillable containers shall comply with:
(i) Section 165.124 with respect to container design of refillable
containers, Sec. 165.125 with respect to the minibulk container drop
test methodology, Sec. 165.126 with respect to certification of
containers, and Sec. 165.128 with respect to recordkeeping pertaining
to container design.
(ii) Section 165.130 with respect to registrant responsibilities
concerning refilling activities and Sec. 165.132 with respect to
recordkeeping pertaining to these responsibilities.
(iii) Section 165.134 with respect to refiller responsibilities and
procedures and Sec. 165.136 with respect to recordkeeping pertaining to
these responsibilities and procedures.
(iv) Section 165.139 with respect to compliance dates.
(2) Registrants who distribute or sell pesticide products to
refillers for repackaging into refillable containers shall comply with:
(i) Section 165.124 with respect to container design of refillable
containers, Sec. 165.126 with respect to certification of containers,
and Sec. 165.128 with respect to recordkeeping pertaining to container
design.
(ii) Section 165.129 with respect to the transfer of pesticide
products into refillable containers.
(iii) Section 165.130 with respect to registrant responsibilities
concerning refilling activities and Sec. 165.132 with respect to
recordkeeping pertaining to these responsibilities.
(iv) Section 165.139 with respect to compliance dates.
(3) Refillers shall comply with:
(i) Section 165.134 with respect to refiller responsibilities and
procedures and Sec. 165.136 with respect to recordkeeping pertaining to
these responsibilities and procedures.
(ii) Section 165.139 with respect to compliance dates.
(b) The requirements of this subpart do not apply to:
(1) Containers that contain manufacturing use products, as defined
in Sec. 158.153(h) of this chapter.
(2) Transport vehicles that contain pesticide in pesticide holding
tanks that are an integral part of the transport vehicle and that are
the primary containment for the pesticide.
Sec. 165.124 Container design standards.
(a) General. (1) A pesticide product shall not be distributed or
sold in a refillable container unless the container meets the standards
of this section. The registrant is responsible for assuring that the
refillable containers in which the registrant's product is distributed
or sold meet the standards of this section.
(2) Information on container failures or other incidents involving
pesticide containers which may result in releases of pesticide may be
reportable under section 6(a)(2) of the Act.
(3) Compliance with part 165 container design requirements does not
exempt registrants from compliance with the Department of
Transportation's (DOT) Hazardous Materials Regulations at 49 CFR parts
171 through 180, if DOT's requirements are applicable.
(b) Permanent marking. (1) Each refillable container shall be
permanently marked with the information listed in this paragraph. The
information shall be visibly located on the outside part of the
container except on a closure. Placement on the label or labeling is
not sufficient unless the label is an integral, permanent part of or
permanently stamped on the container. The information shall include:
(i) The name of the container manufacturer.
(ii) The model number assigned to the design type of the container,
preceded by the phrase ``Model No.''.
(iii) The date of manufacture of the container in the order of the
month (two digits) and year (last two digits).
(iv) The rated capacity of the container, in appropriate units of
weight or volume.
(v) The name, symbol, or code of the material(s) from which the
container is constructed.
(vi) A serial number or other identifying code that will
distinguish each individual container from all other containers.
(vii) The phrase ``Meets EPA standards for refillable pesticide
containers.''
(2) If any of this information, such as the date of manufacture,
the rated capacity, the material of construction, or the serial number,
is required by the DOT Hazardous Materials Regulations at 49 CFR parts
171 through 180 or by the terms of a DOT exemption issued under 49 CFR
part 107, then compliance with DOT's requirement will satisfy the
corresponding requirement of paragraph (b).
(c) Minibulk integrity. Each minibulk container design type shall
prevent leakage under conditions of normal storage, distribution, sale,
and use.
(d) Drop test for minibulk containers. (1) The applicable drop test
specified in Sec. 165.125 shall be successfully performed on each
minibulk container design type before a container of the design type is
used for the sale or distribution of the pesticide product. Section
165.125 prescribes the drop test methodology for flexible, metal, and
rigid plastic minibulk containers.
(2) Each minibulk container shall be capable of passing the
appropriate drop test.
(3) The testing shall be conducted in accordance with the Good
Laboratory Practice Standards in part 160 of this chapter.
(4) If a pesticide product is required to be packaged according to
the DOT Hazardous Materials Regulations at 49 CFR parts 171 through 180
or by the terms of a DOT exemption issued under 49 CFR part 107 and the
DOT requirements include a drop test, then compliance with DOT's drop
test requirements will satisfy the requirements of this paragraph.
(e) Apertures. Each aperture of a liquid minibulk container shall
have a one-way valve, a tamper-evident device, or both.
(f) Standards for bulk containers. The standards in Sec. 165.124(f)
apply only to bulk containers at the refilling establishments of
refillers operating under written contract to or written authorization
from a registrant.
(1) Container integrity. (i) Except during a civil emergency or an
act of God (any unanticipated grave natural disaster or other natural
phenomenon of an exceptional, inevitable, and irresistible character,
the effects of which could not have been prevented or avoided by the
exercise of due care or foresight), each liquid bulk and dry bulk
container and its appurtenances shall meet the following standards:
(ii) Each liquid bulk and dry bulk container and its appurtenances
shall be resistant to extreme changes in temperature and constructed of
materials that are adequately thick to not fail and that are resistant
to corrosion, puncture, or cracking.
(iii) Each liquid bulk and dry bulk container shall be capable of
withstanding all operating stresses, taking into account static head,
pressure buildup from pumps and compressors, and any other foreseeable
mechanical stresses to which the container may be subjected in the
course of operations.
(2) Vent. Each liquid bulk container shall be equipped with a vent
or other device designed to relieve excess pressure, prevent losses by
evaporation, and exclude precipitation.
(3) Gauge. External sight gauges, which are pesticide containing
hoses or tubes that run vertically along the exterior of the container
from the top to the bottom, are prohibited on liquid bulk containers.
(4) Shutoff valve. Each liquid bulk container connection, except
for vents, shall be equipped with a shutoff valve which can be locked
closed.
Sec. 165.125 Minibulk container drop test methodology.
(a) General. This section prescribes the drop test methodology for
flexible, metal, and rigid plastic minibulk containers.
(b) Preparation. (1) The test sample shall consist of at least one
minibulk container taken at random.
(2) The test shall be carried out on minibulk containers prepared
for transport. Any pump, valve, meter, hose, or other appurtenance that
would be attached to the container during transportation, storage, or
use shall be attached during the test.
(3) The pesticide to be transported in the minibulk container may
be replaced by other substances, as specified in paragraph (b)(4),
(b)(5), or (b)(6) of this section. The registrant is responsible for
selecting an appropriate test substance.
(4) For dry pesticides, when another substance is used it shall
have the same physical characteristics (mass, grain size, etc.) as the
pesticide to be carried. It is permissible to use additives, such as
bags of lead shot, to achieve the requisite total package mass, so long
as they are placed so that the test results are not affected.
(5) For liquid pesticides, when another substance is used, its
relative density and viscosity shall be similar to those of the
pesticide to be carried. The registrant is responsible for determining
whether a test substance has a relative density and viscosity similar
to the pesticide to be carried.
(6) Water may be used for the liquid drop test under the following
conditions:
(i) Where the pesticide to be carried has a relative density not
exceeding 1.2, the drop height shall be that specified in paragraph
(d)(6) or (e)(7) of this section for that minibulk container.
(ii) Where the pesticide to be carried has a relative density
exceeding 1.2, the drop height shall be that specified in paragraph
(d)(6) or (e)(7) of this section for that minibulk container multiplied
by the ratio of the relative density of the pesticide to be carried,
rounded off to the first decimal, to 1.2, i.e., relative density x
specified drop height.
(7) If the minibulk container passes the test, the test records
shall include the number of containers of that particular design type
that were tested.
(c) Dry minibulk containers that consist of flexible bodies. (1)
Minibulk containers with flexible bodies are those that consist of a
body constituted of film, woven fabric or any other flexible materials
or combinations thereof.
(2) The dry minibulk container shall be filled to not less than 95
percent of its capacity and to its maximum permissible load, the load
being evenly distributed.
(3) The dry minibulk container shall be dropped on its base on to a
rigid, non-resilient, smooth, flat, and horizontal surface.
(4) The dry minibulk container shall be dropped from a height of at
least 0.8 meters (2.6 feet).
(5) The dry minibulk container shall pass the test successfully if
there is no loss of contents after one drop. A slight discharge, e.g.,
from closures or stitch holes, upon impact shall not be considered to
be a failure of the dry minibulk container provided that no further
leakage occurs after the dry minibulk container has been raised clear
of the ground.
(d) Minibulk containers that consist of metal bodies. (1) A dry
minibulk container shall be filled to not less than 95 percent of its
capacity.
(2) A liquid minibulk container shall be filled to not less than 98
percent of its capacity.
(3) Pressure relief devices shall be removed and their apertures
plugged, or shall be rendered inoperative.
(4) The minibulk container shall be dropped on to a rigid, non-
resilient, smooth, flat, and horizontal surface, in such a manner as to
ensure that the point of impact is on that part of the base of the
minibulk container considered to be the most vulnerable.
(5) A dry minibulk container shall be dropped from a height of at
least 0.8 meters (2.6 feet).
(6) A liquid minibulk container shall be dropped from a height of
at least 1.2 meters (3.9 feet).
(7) The minibulk container shall pass the test successfully if
there is no loss of contents after one drop. A slight discharge from a
closure upon impact shall not be considered to be a failure of the
minibulk container provided that no further leakage occurs.
(e) Minibulk containers that consist of rigid plastic bodies. (1) A
dry minibulk container shall be filled to not less than 95 percent of
its capacity.
(2) A liquid minibulk container shall be filled to not less than 98
percent of its capacity.
(3) Arrangements provided for pressure relief may be removed and
plugged or rendered inoperative.
(4) This test shall be carried out when the temperature of the test
container and its contents have been reduced to -18 degrees Celsius (0
degrees Fahrenheit) or lower. Test liquids shall be kept in the liquid
state, if necessary by the addition of anti-freeze.
(5) The minibulk container shall be dropped on to a rigid, non-
resilient, smooth, flat, and horizontal surface, in such a manner as to
ensure that the point of impact is on that part of the base of the
minibulk container considered to be the most vulnerable.
(6) A dry minibulk container shall be dropped from a height of at
least 0.8 meters (2.6 feet).
(7) A liquid minibulk container shall be dropped from a height of
at least 1.2 meters (3.9 feet).
(8) The minibulk container shall pass the test successfully if
there is no loss of contents after one drop. A slight discharge from a
closure upon impact shall not be considered to be a failure of the
minibulk container provided that no further leakage occurs.
Sec. 165.126 Certification.
(a) Certification. Each registrant who distributes or sells a
pesticide product to a refiller for repackaging into refillable
containers and each registrant who distributes or sells a pesticide
product in refillable containers shall certify to the Agency that all
refillable containers in which the pesticide product is distributed or
sold meet the standards of Sec. 165.124.
(b) Contents of the certification. The certification for each
pesticide product shall contain the following:
(1) The name and EPA registration number of the pesticide product
to which the certification applies; the registrant's name and address;
the date; and the name, title, signature, and telephone number of the
company official making the certification.
(2) A written statement that the refillable container(s) in which
the pesticide product is distributed or sold meet the standards of
Sec. 165.124. The statement, ``I certify that the refillable
container(s) used for the distribution or sale of this pesticide
product meet the standards of 40 CFR 165.124.'' will satisfy this
requirement.
(c) Submission of certification. Certification shall be submitted
with each application for a new registration. For pesticide products
registered as of [date of publication of the final rule in the Federal
Register], a certification shall be submitted according to the
compliance schedule in Sec. 165.139.
(d) Address. Certifications shall be submitted to the following
address: U.S. Environmental Protection Agency, Office of Pesticide
Programs, Registration Division (7505C), 401 M St., SW, Washington, DC
20460.
Sec. 165.128 Container design recordkeeping and inspection.
Each registrant who distributes or sells a pesticide product to a
refiller for repackaging into refillable containers and each registrant
who distributes or sells a pesticide product in refillable containers
shall maintain the records in this section for the refillable
containers which are listed as acceptable for the sale or distribution
of the product. The records shall be maintained for as long as the
registrant authorizes the container to be used and for 3 years
thereafter. The registrant, upon request of any officer or employee of
the Agency or of any State or political subdivision duly designated by
the Agency, shall furnish or make available for inspection and copying
the records as specified in paragraphs (a) through (c) of this section.
The records in paragraphs (a) and (b) of this section shall be
maintained for each design type.
(a) Description of container. The registrant shall keep, for all
refillable containers, a description of the container, including but
not limited to the kind of refillable container (liquid minibulk,
liquid bulk, etc.), the model number of the container, the container
manufacturer, and its design type parameters.
(b) Minibulk containers. (1) The registrant shall keep at least one
of the following records pertaining to the drop test requirement in
Sec. 165.124(d) for minibulk containers:
(i) A copy of the test data, including a description of the test, a
description of the container tested (including all of the information
specified in paragraph (a) of this section), the test results
(including the results of any failed test(s)), the date and location of
the test, and the names of the test operators.
(ii) A letter from the container manufacturer that verifies that
the container design type has been tested according to the methodology
in Sec. 165.125 and that includes a description of the test, a
description of the container tested (including all of the information
specified in paragraph (a) of this section), the test results
(including the results of any failed test(s)) and the location of the
original test data.
(iii) A letter from the facility that conducted the test that
verifies the container design type has been tested according to the
methodology in Sec. 165.125 and that includes a description of the
test, a description of the container including all of the information
specified in paragraph (a) of this section, the test results (including
the results of any failed test(s)) and the location of the original
test data.
(2) The registrant shall keep with the drop test records a
statement of compliance or noncompliance with respect to Good
Laboratory Practice Standards, as described at Sec. 160.12 of this
chapter.
(3) The Agency reserves the right to require the registrant, on a
case by case basis, to submit the drop test data for any pesticide
product registered or proposed for registration.
(c) Certification. The registrant shall keep a copy of the
certification described in Sec. 165.126 for each pesticide product.
Sec. 165.129 Transfer of registered pesticide products into refillable
containers.
(a) A registrant may allow a refiller to repackage the registrant's
pesticide product into refillable containers and to distribute or sell
such repackaged product under the registrant's existing registration if
the following conditions are met:
(1) The repackaging results in no change to the pesticide
formulation.
(2) The pesticide product is repackaged at a producing
establishment registered with EPA as required by Sec. 167.20 of this
chapter.
(3) The registrant has made one of the following arrangements, if
applicable.
(i) The registrant has entered into a written contract with the
refiller to repackage the pesticide product at a registered
establishment and to use the registrant's pesticide product label.
(ii) The registrant has provided written authorization to the
refiller to repackage the pesticide product at a registered
establishment and to use the registrant's pesticide product label.
(4) The pesticide product is repackaged only into refillable
containers that meet the container design standards of Sec. 165.124.
(5) The pesticide product is labeled with the product's label with
no changes except the addition of an appropriate net contents statement
and the EPA establishment number.
(b) Repackaging a pesticide product for distribution or sale
without either obtaining a registration, or meeting all of the
conditions in paragraph (a) of this section is a violation pursuant to
section 12 of the Act.
(c) Both the registrant and the refiller that is repackaging the
pesticide product under contract to or written authorization from the
registrant may be liable for violations pertaining to the repackaged
product.
Sec. 165.130 Registrant responsibilities concerning refilling
activities.
(a) General responsibilities. (1) If a registrant is allowing a
refiller to repackage the registrant's product under a written contract
or a written authorization as specified in Sec. 165.129(a), the
registrant shall provide the written contract or written authorization
to the refiller before the registrant distributes or sells the
pesticide product to the refiller.
(2) The registrant is responsible for the pesticide product
repackaged and distributed or sold by a refiller operating under
written contract or written authorization not being adulterated or
different from the composition as described in the statement required
in connection with registration under section 3 of the Act.
(b) Developing information. Each registrant who distributes or
sells a pesticide product to a refiller for repackaging into refillable
containers and each registrant who distributes or sells pesticide
product in refillable containers shall develop the following:
(1) The registrant shall develop, for the pesticide product, a
written refilling residue removal procedure, which describes the
procedures for removing pesticide residues from a container before it
is refilled.
(i) The refilling residue removal procedure shall be adequate to
ensure that the composition of the pesticide does not differ at the
time of its distribution or sale from its composition as described in
the statement required to be submitted by the registrant in connection
with registration under section 3 of the Act.
(ii) If the refilling residue removal procedure requires the use of
a solvent other than the diluent used for application of the pesticide
as specified on the label under ``Directions for Use'', or if there is
no diluent used for application, the refilling residue removal
procedure shall describe how to manage the rinsate resulting from the
procedure in accordance with applicable Federal and State regulations.
(2) The registrant shall develop a written list of acceptable
refillable containers (minibulk and bulk) which can be used for the
sale or distribution of the registrant's pesticide product.
(i) Acceptable containers are those which the registrant has
determined meet the standards in Sec. 165.124 and are compatible with
the pesticide formulation to which the written list of acceptable
containers applies.
(ii) The registrant shall identify the containers as acceptable by
specifying, at a minimum, the manufacturer of the container and the
model number of the container.
(c) Providing information. (1) Each registrant whose pesticide
product is repackaged by a refiller into refillable containers shall
provide the refiller with all of the information and documentation
described in paragraphs (c)(2)(i) through (c)(2)(iii) of this section
before or at the time of sale or distribution of the pesticide product
to the refiller.
(2) The registrant shall provide the refiller with:
(i) The written refilling residue removal procedure for the
pesticide product.
(ii) The written list of acceptable containers for the pesticide
product.
(iii) The pesticide product's label and labeling.
Sec. 165.132 Registrant recordkeeping and inspections.
(a) Each registrant who distributes or sells a pesticide product to
a refiller for repackaging into refillable containers shall maintain
the records listed in paragraphs (d)(1) through (d)(3) of this section
for that pesticide product. The records shall be maintained for as long
as the registrant distributes or sells the pesticide product to a
refiller and for 3 years thereafter.
(b) Each registrant who distributes or sells a pesticide product in
refillable containers shall maintain the records listed in paragraphs
(d)(2) through (d)(3) of this section for that pesticide product. The
records shall be maintained for as long as the registrant distributes
or sells the pesticide product in refillable containers and for 3 years
thereafter.
(c) The registrant, upon request of any officer or employee of the
Agency or of any State or political subdivision duly designated by the
Agency, shall furnish or make available for inspection and copying the
records specified in paragraphs (d)(1) through (d)(3) of this section.
(d) The registrant shall keep the following records:
(1) Each written contract entered into with a refiller and each
written authorization provided to a refiller for repackaging the
registrant's pesticide product into refillable containers.
(2) The written refilling residue removal procedure for the
pesticide product.
(3) The written list of acceptable containers for the pesticide
product.
Sec. 165.134 Refiller responsibilities and procedures.
All refilling operations by a refiller shall be conducted in
accordance with this section.
(a) Items in possession of refiller. Before repackaging a pesticide
product into any refillable container for distribution or sale, a
refiller shall have in its possession the following items:
(1) The written contract or written authorization, as described in
Sec. 165.129(a), from the product's registrant for the pesticide
product. A written contract or written authorization is not required if
the registrant of the product is the refiller.
(2) The pesticide product's label and labeling.
(3) The registrant's written refilling residue removal procedure
for the pesticide product.
(4) The registrant's written list of acceptable containers for the
pesticide product.
(b) Product integrity. A refiller is responsible for the pesticide
product which the refiller repackages into refillable containers and
distributes or sells not being adulterated or different from the
composition as described in the statement required in connection with
registration under section 3 of the Act.
(c) Refilling conditions. (1) A refiller shall:
(i) Repackage a pesticide product only into a refillable container
that is identified on the list of acceptable containers provided by the
registrant.
(ii) Not change the pesticide formulation, unless the refiller has
a registration for the new formulation.
(2) Standards that may be applicable for secondary containment
units and containment pads are located in subpart H of this part.
(d) Identification of pesticide previously contained in refillable
container. A refiller shall identify the pesticide product previously
contained in the refillable container to determine whether a residue
removal procedure must be conducted in accordance with paragraph (g) of
this section. The refiller can identify the previous pesticide product
by reference to the label or labeling.
(e) Container inspection. Before repackaging a pesticide product
into any refillable container, a refiller shall visually inspect the
exterior and interior (if possible) of the container and the exterior
of appurtenances to determine whether the container meets the necessary
criteria with respect to continued container integrity, required
markings, age of the container, and tamper-evident devices. The
container shall fail the inspection, and shall not be refilled, if:
(1) The integrity of the container is compromised in any of the
following ways:
(i) There is significant corrosion or ultraviolet light damage.
(ii) There are structural defects including, but not limited to,
significant cracks, visible holes, bad dents, or defective or weakened
welds.
(iii) There is damage to the fittings, valves, tamper-evident
devices or other appurtenances that could affect the integrity of the
container.
(2) The container does not bear the permanent markings required by
Sec. 165.124, or such markings are not legible.
(3) The container does not have an intact and functioning one-way
valve or tamper-evident device on each aperture, if required.
(f) Age of plastic liquid minibulk containers. A refiller shall not
repackage a pesticide product into a plastic liquid minibulk container
more than 6 years after the date of manufacture of the container.
(g) Residue removal procedures. (1) A refiller shall conduct the
pesticide product's refilling residue removal procedures before
repackaging the pesticide product into a refillable container, unless
all of the following conditions are met:
(i) Each tamper-evident device is intact, if the refillable
container has one or more tamper-evident devices.
(ii) The container previously held a product with a single active
ingredient and is being used to repackage a product with the same
single active ingredient.
(iii) There is no reaction or interaction between the pesticide
product being repackaged and the residue remaining in the container
that would cause the composition of the product being repackaged to
differ from its composition as described in the statement required to
be submitted by the registrant in connection with registration under
section 3 of the Act.
(2) In addition to conducting the refilling residue removal
procedure, in all cases where the container has a broken (not intact)
tamper-evident device, other procedures may need to be taken to assure
that product integrity is maintained.
(h) Quantity that may be refilled. A refiller may repackage any
quantity of a pesticide product into a refillable container up to the
rated capacity of the container.
(i) Relabeling procedures. A refiller shall securely attach the new
label (such that the label can reasonably be expected to remain affixed
during the foreseeable conditions and period of use). The new label and
labeling shall comply in all respects with the requirements of
Sec. 156.10 of this chapter. In particular, the refiller shall ensure
that the net contents statement and EPA establishment number appear on
the new label.
Sec. 165.136 Refiller recordkeeping and inspections.
Each refiller shall maintain the records listed in this section.
The refiller, upon request of any officer or employee of the Agency or
of any State or political subdivision duly designated by the Agency,
shall furnish or make available for inspection and copying the records
listed in this section.
(a) Recordkeeping for each pesticide product. The following records
shall be maintained for as long as the refiller distributes or sells a
pesticide product in refillable containers, and for 3 years thereafter.
The refiller shall maintain copies of the following:
(1) The written contract or written authorization, as described in
Sec. 165.129(a), from the product's registrant for the pesticide
product.
(2) The registrant's written refilling residue removal procedure
for the pesticide product.
(3) The registrant's written list of acceptable containers for the
pesticide product.
(b) Return of refillable containers. For each refillable container
that has been used in the distribution or sale of a pesticide product
and delivered to the refiller to be refilled, the following information
shall be recorded and maintained for 3 years after the date of receipt:
(1) The name and address of the person providing the refillable
container.
(2) The serial number of the refillable container.
(3) The date the refillable container was received.
(4) The name and EPA registration number of the pesticide product
that was last distributed or sold in the refillable container.
(c) Refilling of refillable containers. Each time a refiller
repackages a pesticide product into a refillable container and
distributes or sells the product, the following records shall be
generated and maintained for at least 3 years after the date of
repackaging:
(1) The name, EPA registration number, and amount of the pesticide
product distributed or sold in the refillable container.
(2) The date of the distribution or sale.
(3) The name and address of the consignee.
(4) The serial number of the refillable container.
(5) A record that the refiller has conducted the container
inspection procedure and the results.
(6) A record of whether a refilling residue removal procedure was
conducted, and if not, why not.
Sec. 165.139 Compliance dates.
(a) As of [2 years after the date of publication of the final rule
in the Federal Register] all pesticide product distributed or sold in
refillable containers shall be distributed or sold only in compliance
with this subpart.
(b) Certifications for pesticide products registered as of [date of
publication of the final rule in the Federal Register] shall be
submitted to and received by the Agency by [2 years after the date of
publication of the final rule in the Federal Register].
Subpart H -- Standards for Pesticide Containment Structures
Sec. 165.140 Scope and purpose.
(a) Scope. This subpart prescribes the requirements for containment
of stationary bulk containers and pesticide dispensing areas at
pesticide refilling establishments and at certain other facilities that
store bulk quantities of pesticide products.
(b) Purpose. The purpose of this subpart is to protect human health
and the environment from exposure to pesticides resulting from spills
and leaks and to reduce the generation of wastes associated with the
storage and handling of bulk quantities of pesticide products and with
pesticide container refilling operations.
Sec. 165.141 Applicability to facilities and persons.
(a) General applicability. The requirements of this subpart apply
to each facility identified in paragraph (b) of this section which
contains a stationary bulk container or a pesticide dispensing area
used for an agricultural pesticide.
(b) Facilities covered. The requirements of this subpart cover:
(1) Refilling establishments whose principal business is retail
sale.
(2) Custom blenders, as defined in Sec. 167.3 of this chapter.
(3) Facilities of businesses which apply an agricultural pesticide
for compensation (other than trading of personal services between
agricultural producers).
(c) Responsibilities of owners and operators. The owners and
operators of the facility are responsible for assuring that the
facility complies with the requirements of this subpart.
Sec. 165.142 Applicability to stationary bulk containers and pesticide
dispensing areas.
(a) Stationary bulk containers. (1) Unless exempted by paragraph
(a)(2) of this section, each stationary bulk container at a facility
shall be protected by a containment structure which shall meet:
(i) The general requirements of Sec. 165.146.
(ii) The secondary containment requirements of Sec. 165.148 for
liquid bulk containers or, as applicable, of Sec. 165.150 for dry bulk
containers.
(2) A stationary bulk container is exempt from the requirements of
this subpart if any of the following conditions exists:
(i) All pesticide that can be removed from the container by
customary methods such as draining, pumping or aspirating has been
removed (whether or not residues have been removed by washing or
rinsing).
(ii) The container holds only pesticide rinsates or wash waters,
and is so labeled.
(iii) The container holds only pesticides which would be gaseous if
released at atmospheric temperature and pressure.
(iv) The container is dedicated to non-pesticide use, and is so
labeled.
(b) Pesticide dispensing areas. (1) Unless exempted in paragraph
(b)(2) of this section, each pesticide dispensing area where any of the
following activities are conducted must be protected by a containment
structure which meets the general requirements of Sec. 165.146 and the
specific requirements for containment pads of Sec. 165.152:
(i) The dispensing of pesticide from a stationary bulk container
for any purpose, including, but not limited to, refilling refillable
containers, service containers, transport vehicles or application
equipment, or emptying prior to cleaning.
(ii) The dispensing of pesticide from any container other than a
stationary bulk container for the purpose of refilling a refillable
container for sale and distribution. Containment requirements do not
apply if pesticide is dispensed from such containers for purposes other
than refilling.
(iii) The emptying, cleaning or rinsing of any refillable
container.
(iv) The dispensing of pesticide from a transport vehicle for
purposes of filling a stationary bulk container.
(2) A pesticide dispensing area is exempt from the requirements of
this subpart if any of the following conditions exist:
(i) The only pesticides in the pesticide dispensing area are
pesticides which would be gaseous when released at atmospheric
temperature and pressure.
(ii) The only pesticide containers refilled or emptied within the
pesticide dispensing area are stationary bulk containers and the area
is protected by a secondary containment unit meeting the requirements
of this subpart.
(iii) The pesticide dispensing area is used solely for dispensing
pesticide from a rail car which does not remain at a facility long
enough to meet the definition of a stationary bulk container.
Sec. 165.144 Existing and new containment structures.
(a) Existing containment structures. For purposes of this subpart,
existing containment structure means a containment structure for which
installation has commenced on or before [3 months after the date of
publication of the final rule in the Federal Register]. Installation is
considered to have commenced if:
(1) The owner or operator has obtained all Federal, State, and
local approvals or permits necessary to begin physical construction of
the containment structure; and if
(2)(i) Either a continuous on-site physical construction or
installation program has begun; or
(ii) The owner or operator has entered into contractual
obligations, which cannot be canceled or modified without substantial
loss, for physical construction or installation of the containment
structure, to be completed within a reasonable time.
(b) New containment structures. For purposes of this subpart, new
containment structure means a containment structure for which
installation has commenced after May 12, 1994.
Sec. 165.146 Containment structures: general requirements.
Each stationary bulk container and each pesticide dispensing area
shall be protected by a containment structure which meets the
requirements of this subpart.
(a) Material. (1) The containment structure shall be constructed of
reinforced concrete or other rigid material which will withstand the
full hydrostatic head (dynamic or static), load and impact of any
pesticides, precipitation, other substances, equipment, and
appurtenances placed within the structure.
(2) The containment structure shall not be constructed of natural
earthen material, unfired clay, or asphalt.
(3)(i) During the interim period as specified in Sec. 165.156(b),
each existing containment structure shall have a hydraulic conductivity
less than or equal to 1 x 10-6 centimeters per second. This
standard may be satisfied by the use, separate or combined, of any of
the following materials:
(A) Structural materials.
(B) Surface sealants or coatings.
(C) A continuous liner at the bottom of the containment structure.
(ii) Each new containment structure shall have a hydraulic
conductivity less than or equal to 1 x 10-7 centimeters per
second. After the expiration of the interim period specified in
Sec. 165.156(b), each existing containment structure also shall meet
this requirement. The standard for hydraulic conductivity may be
satisfied with materials in the manner specified in paragraph
(a)(3)(i)(A) through (a)(3)(i)(C) of this section.
(4) The containment structure shall be constructed of materials
that are resistant to the pesticide.
(b) Design and construction. (1) The containment structure shall,
at a minimum, prevent water and other liquids from seeping into or
flowing onto it from adjacent land or structures during a 25-year, 24-
hour rainfall event.
(2) Appurtenances and pesticide containers shall be protected
against damage from operating personnel and moving equipment. Means of
protection include but are not limited to supports to prevent sagging,
flexible connections, the use of guard rails, barriers, and protective
cages.
(3) No new containment structure shall have an appurtenance,
discharge outlet or gravity drain through the base or wall, except for
direct interconnections between adjacent containment structures which
meet the requirements of this subpart. Appurtenances shall be
configured in such a way that spills or leaks readily can be observed.
After the expiration of the interim period as specified in
Sec. 165.156(b), each existing containment structure also shall meet
this standard.
(c) Operation. (1) The owner or operator shall operate the
structure in a manner that prevents pesticides or materials containing
pesticides from escaping from the containment structure. This includes,
but is not limited to, pesticide residues washed off the containment
structure by rainfall or liquids used for cleaning the area within the
containment structure. All materials containing pesticide residue shall
be handled in accordance with label directions and applicable Federal,
State and local laws and regulations.
(2) The owner or operator shall ensure that transfers of pesticides
between pesticide containers or between transport vehicles and
containers are attended at all times.
(3) The owner or operator shall ensure that each lockable valve, if
required by Sec. 165.124(e)(4), on a stationary bulk container shall be
locked closed whenever the facility is unattended.
(4) The owner or operator shall ensure that spills and leaks of
pesticide on or in any containment structure are collected, and
recovered in a manner that ensures protection of human health and the
environment (including surface water and ground water) and ensures the
maximum practicable recovery of the pesticide spilled or leaked. At a
minimum, cleanup shall occur no later than the end of each day on which
pesticides have been spilled or leaked in or on the containment
structure.
(5) The owner or operator shall ensure that all materials resulting
from spills and leaks are managed in accordance with label instructions
and applicable Federal, State and local laws and regulations.
(d) Inspection and maintenance. (1) At least monthly during periods
when pesticides are being stored or dispensed on the containment
structure, the owner or operator shall inspect each stationary bulk
container and its appurtenances and each containment structure for
visible signs of wetting, discoloration, blistering, bulging,
corrosion, cracks or other signs of damage or leakage.
(2) The owner or operator shall repair any areas showing visible
signs of damage and seal any cracks and gaps in the containment
structure and appurtenances with material that is resistant to the
pesticide being stored or dispensed and that meets the standard for
hydraulic conductivity set forth in Sec. 165.146(a)(3)(i) or
(a)(3)(ii), as applicable.
(3) No pesticide shall be stored or dispensed on a containment
structure if the structure fails to meet the requirements of this
subpart, until suitable repairs have been made. Prompt removal of
pesticides, including emptying of bulk containers, in order to effect
repairs or recovery of spilled material is acceptable.
Sec. 165.148 Specific requirements for containment of stationary
liquid bulk containers.
Each stationary liquid bulk container shall be protected by a
secondary containment unit which meets the requirements of Sec. 165.146
and of this section.
(a) Capacity. (1) During the interim period as specified in
Sec. 165.156(b), each existing secondary containment unit shall have,
at a minimum, the following capacity, in addition to compensating for
any volume displaced by containers and appurtenances:
(i) At least 110 percent of the capacity of the largest stationary
bulk container within a secondary containment unit that is not
protected from precipitation.
(ii) At least 100 percent of the capacity of the largest stationary
bulk container within a secondary containment unit that is protected
from precipitation.
(2) Each new secondary containment unit shall have, at a minimum,
the following capacity, in addition to compensating for any volume
displaced by containers and appurtenances:
(i) At least 125 percent of the capacity of the largest stationary
bulk container within a secondary containment unit that is not
protected from precipitation.
(ii) At least 110 percent of the capacity of the largest stationary
bulk container within a secondary containment unit that is protected
from precipitation.
(3) After the expiration of the interim period as specified in
Sec. 165.156(b), each existing secondary containment unit shall meet
the requirements of paragraph (a)(2) of this section.
(b) Design and construction. (1) Each new secondary containment
unit shall allow for the observation of leakage from the base of any
enclosed stationary bulk container. This requirement may be achieved by
elevating the stationary bulk container on structures such as legs,
skids, raised beds of rounded gravel, or by other methods, provided
that leaked material readily can be observed and the integrity of the
secondary containment unit is preserved. After the expiration of the
interim period as specified in Sec. 165.156(b), each existing secondary
containment unit also shall meet this standard.
(2) Any stationary bulk container protected by a secondary
containment unit shall be adequately elevated or anchored to prevent
floatation in the event that the secondary containment unit fills with
liquid.
(c) Inspection and maintenance. Each month during the interim
period as specified in Sec. 165.156(b), the owner or operator shall
inventory and reconcile the contents of any stationary bulk pesticide
container which is protected by an existing secondary containment unit
but not elevated (as described in paragraph (b)(1) of this section) so
as to allow for observation for leakage beneath the container.
Inventory and reconciliation shall compare the quantity of material
measured in the bulk container versus the quantity expected (as
calculated by adjusting the quantity of pesticide measured in the bulk
container at the previous month's inventory for subsequent amounts
dispensed into and from the container).
Sec. 165.150 Specific containment requirements for stationary dry bulk
containers.
(a) Each stationary dry bulk container shall be protected by a
secondary containment unit which meets the requirements of Sec. 165.146
and of this section.
(b) Each new secondary containment unit shall have, at a minimum,
the capacity to contain 100 percent of the volume of the largest
stationary dry bulk container within the containment structure, in
addition to compensating for any volume displaced by containers and
appurtenances. After the expiration of the interim period as specified
in Sec. 165.156(b), each existing secondary containment unit also shall
meet this requirement.
Sec. 165.152 Specific containment requirements for pesticide
dispensing areas.
Each pesticide dispensing area shall be protected by a containment
pad which meets the requirements of Sec. 165.146 and this section.
(a) Capacity. The containment pad shall have, at a minimum, a
holding capacity of 1,000 gallons or, if no container or pesticide-
holding equipment on the containment pad exceeds a capacity of 1,000
gallons, the minimum capacity of the containment pad shall be at least
100 percent of the capacity of the largest pesticide container or
pesticide-holding equipment used on the pad.
(b) Design and construction. (1) The containment pad shall be
designed and constructed to intercept leaks and spills of pesticides
which may occur in the pesticide dispensing area. The surface area of
the containment pad shall be sufficient to extend completely beneath
any container on the pad except transport vehicles which are dispensing
pesticide for sale or distribution to a facility's stationary bulk
container. For such vehicles the surface area of the containment pad,
at a minimum, shall accommodate the portion of the vehicle where the
delivery hose or device couples to the vehicle.
(2) The surface of each new containment pad shall be sloped toward
a liquid-tight sump where liquids can be collected for removal. After
the expiration of the interim period as specified in Sec. 165.156(b),
each existing containment pad also shall meet this requirement.
(3) The containment pad shall have a means of removing and
recovering spilled, leaked, or discharged material and rainfall such as
by a manually activated pump. Automatically activated pumps lacking
automatic overflow cutoff switches for the receiving container are
prohibited.
Sec. 165.153 Integrated systems.
Containment pads and secondary containment units may be combined
into integrated systems provided the requirements of Sec. 165.146 and,
as applicable, Sec. Sec. 165.148, 165.150, and 165.152 are satisfied
separately. If more than one stationary bulk container is located at a
facility, the requirements for secondary containment units may be
applied individually to each stationary bulk container or collectively,
at the option of the facility.
Sec. 165.156 Compliance dates.
(a) As of [2 years after the date of publication of the final rule
in the Federal Register] each new containment structure shall be in
compliance with all applicable requirements of this subpart.
(b) The interim period of this subpart begins on [2 years after the
date of publication of the final rule in the Federal Register] and ends
on [10 years after the date of publication of the final rule in the
Federal Register]. During this interim period, each existing
containment structure shall be in compliance with those requirements
identified as interim and shall be fully in compliance with all other
applicable requirements.
(c) As of [10 years after the date of publication of the final rule
in the Federal Register] each existing facility shall be in compliance
with the full requirements of this subpart. Interim requirements shall
no longer apply to any facility or containment structure.
Sec. 165.157 Recordkeeping requirements and inspections.
Each owner or operator shall maintain the records listed in this
section. The owner or operator, upon request of any officer or employee
of the Agency or of any State or political subdivision duly designated
by the Agency, shall furnish or make available for inspection and
copying the records listed in this section.
(a) The following records shall be maintained for at least 3 years:
(1) Records of inspection and maintenance for each containment
structure and for each stationary bulk container and its appurtenances,
including the name of the person conducting the inspection or
maintenance, date, conditions noted, and maintenance performed.
(2) During the interim period referenced in Sec. 165.156(b),
monthly records of inventory and reconciliation, including for each
stationary bulk container applicable under the provisions of
Sec. 165.148(c), the name of product stored, the quantity measured at
previous inventory, the quantities dispensed from or added to
container, and reconciliation with the quantity measured at the most
recent inventory.
(3) For any dry or liquid bulk container that holds pesticide but
is not protected by a secondary containment unit that meets the
requirements of this subpart, records of the duration over which the
container remains at the same location at the facility.
(b) Each owner or operator shall maintain written confirmation of
hydraulic conductivity as required in Sec. 165.146(a)(3) and (d)(2) and
statements of resistance to the pesticide as required in
Sec. 165.146(a)(4) and (d)(2). The owner or operator shall maintain
these records for as long as the containment structure is in use, and 3
years thereafter.
[FR Doc. 94-2969 Filed 2-10-94; 8:45 am]
BILLING CODE 6560-50-F
