[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Proposed Rules]
[Pages 56918-56944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27397]
[[Page 56917]]
_______________________________________________________________________
Part VII
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 165
Standards for Pesticide Containers and Containment; Proposed Rule
Federal Register / Vol. 64, No. 203 / Thursday, October 21, 1999 /
Proposed Rules
[[Page 56918]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 165
[OPP-190001A; FRL-5776-3]
RIN 2070-AB95
Standards for Pesticide Containers and Containment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule; partial reopening of the comment period.
-----------------------------------------------------------------------
SUMMARY: EPA issued a proposed rule in the Federal Register proposing
container design and residue removal requirements for refillable and
nonrefillable pesticide containers and standards for pesticide
containment structures. (59 FR 6712, Feb. 11, 1994). EPA is today
reopening the comment period to obtain public comment on three issues
brought out in the comments on the proposed rule or by recently enacted
legislation and on one other issue. EPA is considering changes that
would reduce the scope of the container standards, add an exemption for
certain antimicrobial pesticides, and adopt some of the Department of
Transportation (DOT) hazardous materials regulations. EPA is also
seeking comment on the definition for small business used to identify
small pesticide formulators, agrichemical dealers and commercial
pesticide applicators in the small entity impact analysis. These
potential changes, if adopted in the final rule, would support EPA's
goal of pollution prevention by promoting the use of refillable
containers and would harmonize and promote consistency within the
Federal packaging standards by adopting the DOT standards. In addition,
the changes would decrease the estimated economic impact by reducing
the number of pesticide products subject to the container requirements
compared to the original proposal.
DATES: Comments, identified by the docket number OPP-190001A, must be
received on or before December 20, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the ``SUPPLEMENTARY INFORMATION'' section of
this notice.
FOR FURTHER INFORMATION CONTACT: Nancy Fitz, Office of Pesticide
Programs (7506C), 401 M St., SW, Washington, DC 20460; telephone number
(703) 305-7385; and e-mail address: fitz.nancy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are a
pesticide formulator, agrichemical dealer, or an independent commercial
applicator. However, the issues addressed in this action apply mainly
to pesticide formulators. Potentially affected categories and entities
may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS SIC Potentially Affected
Entities
------------------------------------------------------------------------
Pesticide formulators........... 32532 2879 Establishments that
formulate and
prepare
insecticides,
fungicides,
herbicides, or
other pesticides
from technical
chemicals or
concentrates
produced by
pesticide
manufacturing
establishments.
Some formulating
establishments are
owned by the large
basic pesticide
producers and
others are
independent.
Agrichemical dealers............ 44422 5191 Retail dealers that
distribute or sell
pesticides to
agricultural users.
Independent commercial 115112 0721 Businesses that
applicators. apply pesticides
for compensation
(by aerial and/or
ground application)
and that are not
affiliated with
agrichemical
dealers.
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed above could also be
affected. The Standard Industrial Classification (SIC) codes and the
North American Industrial Classification System (NAICS) codes have been
provided to assist you and others in determining whether or not this
action applies to certain entities. To determine whether you or your
business is affected by this action, you should carefully examine the
applicability provisions in Unit VII of this document and in
Secs. 165.100, 165.120, 165.122, 165.140, 165.141, and 165.142 of the
original proposed rule (59 FR 6712, February 11, 1994). If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document and various support documents from the EPA internet Home Page
at http://www.epa.gov/. On the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register - Environmental Documents.'' You can also go
directly to the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/.
2. Fax on Demand. You may request to receive a faxed copy of this
document, as well as some supporting information, if available, by
using a faxphone to call (202) 401-0527 and selecting item 6077. You
may also follow the automated menu.
3. In person. The EPA has established an official record for this
action under docket control number OPP-190001A. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. A public version of this record, including printed,
paper versions of any electronic comments submitted during the comment
period, is available for inspection in the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The PIRIB telephone
number is 703-305-5805.
C. How and to Whom do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To
[[Page 56919]]
ensure proper receipt by EPA, it is imperative that you identify docket
control number OPP-190001A in the subject line on the first page of
your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW, Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is 703-305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in WordPerfect 5.1/
6.1 or ASCII file format. All comments in electronic form must be
identified by the docket control number OPP-190001A. Electronic
comments may also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI Information That I Want to Submit to the
Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit in response to this
document as CBI by marking any part or all of that information as 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 version
of the official record. Information not marked confidential will be
included in the public version of the official record by EPA without
prior notice. If you have any questions about CBI or the procedures for
claiming CBI, please consult with the person identified in the ``FOR
FURTHER INFORMATION CONTACT'' section.
E. What Should I Consider as I Prepare My Comments for EPA?
We invite you to provide your views on the various options we
discuss in this document, new approaches we haven't considered, the
potential impacts of the various options (including possible unintended
consequences), and any data or information that you would like the
Agency to consider during the development of the final action. You may
find the following suggestions helpful for preparing your comments:
Explain your views as clearly as possible.
Describe any assumptions that you use.
Provide solid technical information and/or data to support
your views.
If you estimate potential burden or costs, explain how you
arrive at the estimate.
Tell us what you support, as well as what you disagree
with.
Provide specific examples to illustrate your concerns.
Offer alternative ways to improve the rule.
Make sure to submit your comments by the deadline in this
notice.
To ensure proper receipt by EPA, be sure to identify the
docket control number assigned to this action in the subject line on
the first page of your response. You may also provide the name, date,
and Federal Register citation.
II. Background
A. Statutory Background
Sections 19(e) and (f) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) 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 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.
FIFRA section 19(f) requires EPA to promulgate regulations
``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 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.
In addition, section 19(h), titled ``Relationship to Solid Waste
Disposal Act,'' specifies that nothing in section 19 shall diminish the
authorities or requirements of RCRA.
The Food Quality Protection Act (FQPA) of 1996 amended section
19(h) of FIFRA to add an exemption for certain antimicrobial
pesticides. Since this new statutory language was not in existence at
the time of the original proposed rule, EPA seeks comment on EPA's
interpretation of how this statutory exemption applies to the proposed
container regulations.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.)
requires an agency to prepare a regulatory flexibility analysis for any
rule for which the agency is required to issue a notice of proposed
rulemaking under the Administrative Procedures Act or any other
statute, unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
For the purpose of analyzing potential impacts on small entities,
section 601(6) of the RFA defines small entities to include small
governments, small non-profit organizations, and small businesses,
which are also further defined in section 601. The definition of small
business provided in section 601(3) uses the definition of small
business in section 3 of the Small Business Act, 15 U.S.C. 632, under
which the Small Business Administration (SBA) establishes small
business size standards. 13 CFR 121.201.
In analyzing potential impacts, the RFA recognizes that it may be
appropriate at times to use an alternate definition of small business.
As such, section 601(3) of the RFA provides that an agency may
establish a different definition of small business after consultation
with the SBA Office of Advocacy and after notice and an opportunity for
public comment. In this document, EPA seeks comments on the ``small
business'' definitions used to identify potentially affected small
entities in the initial regulatory
[[Page 56920]]
flexibility analysis that was prepared for the 1994 proposed rule,
i.e., for identifying small pesticide formulators, small agrichemical
dealers, and small commercial pesticide applicators.
B. Regulatory Background
In a Notice of Proposed Rulemaking issued on February 11, 1994 (59
FR 6712) (Ref. 1), EPA proposed standards for pesticide containers and
containment structures. This proposal included requirements for
nonrefillable and refillable containers that would ensure the safe use
and disposal of the containers. The proposal also included standards
for containment structures, which would promote safe storage by
facilitating the safe use, refill, and reuse of refillable containers.
Additionally, the proposed rule contained amendments to the labeling
regulations in 40 CFR part 156 to ensure adequate levels of residue
removal from containers.
The public comment period for the proposed rule closed on July 11,
1994. EPA received about 1,900 pages of comments from over 200
commenters, including many trade associations and individual companies
from the pesticide manufacturing, pesticide retail, and container
manufacturing industries as well as many State regulatory agencies. A
summary of these comments is available in the docket. (Ref. 2)
EPA received many comments during the public comment period on two
of the issues being re-opened for comment in this document;
specifically, the scope of the container standards and the relationship
between the 1994 proposed rule and the Department of Transportation
(DOT) standards for hazardous materials packaging. For each of these
issues, a brief summary of the comments and a description of a modified
regulatory option being considered are provided.
III. Scope of the Container Standards
A. Background on 1994 Proposal
In the February 1994 Notice of Proposed Rule Making (NPRM), EPA
proposed that the container standards would generally apply to all
pesticides and all containers, regardless of the pesticide market
sector (e.g., agricultural, industrial, institutional, household,
etc.), the type of pesticide (e.g., insecticide, herbicide, sanitizer,
disinfectant, etc.), or the type of container (e.g., plastic jug, steel
drum, paper bag, minibulk tank, etc.). Where appropriate, EPA proposed
a limited applicability for specific requirements. For example, the
proposed nonrefillable container dispensing capability standards would
only apply to containers holding liquid pesticides, i.e., those
containers that have the potential to drip or ``glug'' (the common
industry term for not pouring in a continuous, coherent stream) during
pouring.
During the public comment period, many commenters opposed the broad
scope of the proposed container standards and requested EPA to exempt a
specific subset of pesticides from the scope of the container
requirements. The categories of pesticides that were suggested for
exemption from the rule include: (1) Lower-risk pesticides; (2)
nonagricultural pesticides in general; (3) antimicrobial pesticides;
(4) swimming pool chemicals; (5) industrial biocides; and (6)
disinfectants and/or sanitizers. To support the exemption requests,
commenters generally argued that the pesticides suggested for exemption
pose lower risk than agricultural pesticides (e.g., active ingredients
that are less toxic, less persistent, more biodegradable, and/or at a
lower concentration, and the pesticides are in smaller containers,
etc.); that the containers suggested for exemption are handled
differently than containers for agricultural pesticides; and/or it
would be more burdensome for these pesticides/containers to come into
compliance than for agricultural pesticides/containers. See the comment
summary document (Ref. 2) for more information.
B. Regulatory Option Under Consideration
EPA is considering exempting some pesticides and containers from
the final container rule. However, rather than exempting products based
on the pesticide market sector or the type of pesticide, EPA believes
it is more appropriate to exempt pesticides based on the relative risk
they pose.
Under the regulatory option being considered for defining the
general scope of the rule (i.e., for pesticides other than
antimicrobial products that are eligible for exemption), a pesticide
product would be subject to the container standards if the product met
at least one of the criteria being considered: (1) The product is
classified in Toxicity Category I or II; (2) the container capacity is
greater than or equal to the container size criterion of 5 liters (1.3
gallons) or 5 kilograms (11 pounds); or (3) the product is intended for
outdoor use and the label includes at least one of the specified
environmental hazard statements. If the product does not meet any of
these criteria, it would not be subject to the container standards.
(See Unit IV of this document for a discussion of which antimicrobial
pesticides would be subject to the container standards.)
C. Discussion
1. General principle of risk. When considering which pesticides
should be subject to the pesticide container regulations, it is worth
reviewing the goals of the proposed container standards, which include:
Ensuring that pesticide containers are strong and durable
to minimize container failures and the subsequent releases of pesticide
to the environment
Minimizing human exposure during container handling, e.g.,
loading and unloading the container, container cleaning, and management
before disposal
Facilitating container disposal and recycling
Minimizing cross-contamination in refillable containers
Codifying safe refilling management practices
Failure to attain any of these goals could lead to unreasonable
adverse effects on the environment. For example, the first item relates
to an event that can easily be visualized as causing people or the
environment to be directly exposed to pesticides -- a container fails
and releases the pesticide. Regarding the second item, a pesticide user
could be exposed if pesticide splashes or drips from a container while
the user is handling the container. Under exposure scenarios such as
these (or under pesticide exposures during container disposal or
recycling, from cross-contamination or from unsafe refilling
practices), unreasonable adverse effects would be more likely to occur
with pesticides that are higher-risk than with pesticides that are
lower-risk. Therefore, EPA has considered several characteristics of
pesticides and containers to distinguish between those that are higher-
risk and those that are lower-risk in such situations.
2. Toxicity criteria. One factor in distinguishing higher-risk
pesticides is the toxicity of the pesticide. EPA is considering the
following criteria to identify the higher-toxicity, higher-risk
pesticides for general inclusion in the container rule:
i. Toxicity Category I classification
ii. Toxicity Category II classification
iii. One of several environmental hazard statements (e.g. ``This
pesticide is toxic to wildlife.'') on their labels.
The regulations in 40 CFR 156.10(h) define four categories that
account for human toxicity, with Toxicity Category I including the most
toxic pesticides and Toxicity Category IV the least toxic.
[[Page 56921]]
These categories are based on hazard information, including the oral
LD50, inhalation LC50, dermal LD50,
eye effects, and skin effects of the pesticide. The following table 1
describes the hazard indicators defining each toxicity category as set
out in Sec. 156.10(h)(1), the human hazard signal word for each as
required by Sec. 156.10(h)(1)(i), and the precautionary statements
regarding hazard to humans and domestic animals set forth in
Sec. 156.10(h)(2)(i)(B).
Table 1.--Information on Toxicity Categories as set out in 40 CFR 156.10(h)
----------------------------------------------------------------------------------------------------------------
Toxicity Categories
-------------------------------------------------------------------------------
I II III IV
----------------------------------------------------------------------------------------------------------------
Hazard Indicators...............
Oral LD50.................... Up to and From 50 thru 500 From 500 thru Greater than 5,000
including 50 mg/ mg/kg. 5,000 mg/kg. mg/kg
kg.
Inhalation LC50.............. Up to and From 0.2 thru 2 mg/ From 2 thru 20 mg/ Greater than 20 mg/
including 0.2 mg/ kg. kg. kg
kg.
Dermal LD50.................. Up to and From 200 thru From 2,000 thru Greater than
including 200 mg/ 2,000 mg/kg. 20,000 mg/kg. 20,000 mg/kg
kg.
Eye effects.................. Corrosive; corneal Corneal opacity No corneal No irritation.
opacity not reversible within opacity;
reversible within 7 days; irritation
7 days. irritation reversible within
persisting for 7 7 days.
days.
Skin effects................. Corrosive......... Severe irritation Moderate Mild or slight
at 72 hours.. irritation at 72 irritation at 72
hours. hours.
Required Label Language.........
Human hazard signal word...... ``Danger''; and in ``Warning''....... ``Caution''....... ``Caution''
some cases:
``Poison'' and
the skull and
crossbones.
Precautionary statements Fatal (poisonous) May be fatal if Harmful if [No precautionary
regarding hazard to humans if swallowed swallowed swallowed statements
and domestic animals: oral, [inhaled or [inhaled or [inhaled or required.]
inhalation, or dermal absorbed through absorbed through absorbed through
toxicity. skin]. Do not skin]. Do not skin]. Avoid
breathe vapor breathe vapor breathing vapors
[dust or spray [dust or spray [dust or spray
mist]. Do not get mist]. Do not get mist]. Avoid
in eyes, on skin, in eyes, on skin, contact with skin
or on clothing. or on clothing [eyes or
[Front panel [Appropriate clothing].
statement of first aid [Appropriate
practical statement first aid
treatment required.]. statement
required.]. required.].
Precautionary statements Corrosive, causes Causes eye [and Avoid contact with [No precautionary
regarding hazard to humans eye and skin skin] irritation. skin, eyes or statements
and domestic animals: skin damage [or skin Do not get in clothing. In case required.]
and eye local effects. irritation]. Do eyes, on skin, or of contact
not get in eyes, on clothing. immediately flush
on skin, or on Harmful if eyes or skin with
clothing. Wear swallowed. plenty of water.
goggles or face [Appropriate Get medical
shield and rubber first aid attention if
gloves when statement irritation
handling. Harmful required.]. persists.
or fatal if
swallowed.
[Appropriate
first aid
statement
required.].
----------------------------------------------------------------------------------------------------------------
Because these categories cover the full range of toxicities in a
continuum, it is difficult to make a clear-cut distinction among them.
However, EPA is considering an option that would specify the two most
hazardous groups -- Toxicity Categories I and II -- as criteria for
pesticides that would be subject to the container standards. EPA
believes it is appropriate to use classification in Toxicity Categories
I and II as criteria for inclusion in the container standards, because
it would include, by the definitions given in table 1, the most toxic
pesticides. In addition, the specified label language seems to indicate
a notable difference in the hazard posed by pesticides in Toxicity
Category II and those in Toxicity Category III.
The United States is participating in a global effort to harmonize
the classification and labeling of chemicals for human and
environmental hazards, which is being lead by international agencies
such as the Organization for Economic Cooperation and Development
(OECD), World Health Organization, International Labor Organization and
the United Nations Committee of Experts on the Transport of Dangerous
Goods. OECD is the focal point for the harmonization of classification
for health and environmental hazards, including toxicity endpoints for
acute toxicity, reproductive toxicity, carcinogenicity, mutagenicity,
sensitization, irritation and corrosion, and target organ effects and
environmental endpoints for aquatic and terrestrial effects. The
harmonized system is to be based on the intrinsic nature of all
chemicals and mixtures regardless of their intended use (certain
chemicals have both pesticide and non-pesticidal uses).
The global harmonization effort is still under negotiation. A basic
principle of the effort is that the level of protection should not be
reduced. Hazard categories will be defined, but countries will select
elements deemed appropriate for regulating transport, worker and
environmental protection. However, there may be new definitions of each
toxicity category, particularly with regard to inhalation toxicity, and
the number of products captured by each may expand or contract. Since
in this notice EPA is considering an approach of exempting certain
pesticide products from the container standards based on
[[Page 56922]]
their toxicity category, any change in the toxicity classification may
change the universe of products subject to the container rule. If the
final criteria for toxicity categories differ significantly from those
currently used by EPA, a clarification of the products subject to the
container standards can be included in the final rule.
EPA believes it is important and necessary to also account for
environmental factors when evaluating the risk posed by pesticide
containers. The approach EPA is currently considering is to rely on
whether or not at least one of the environmental hazard statements is
included on the label. Some environmental hazard statements are
required by 40 CFR 156.10(h)(2)(ii). For the purposes of the regulatory
option being considered here, EPA is looking at the following
environmental hazard statements (label statements) or similar warnings
or precautionary statements pertaining to wildlife, fish, birds, or
groundwater:
This pesticide is toxic (or extremely toxic) to wildlife.
This pesticide is toxic (or extremely toxic) to fish.
This pesticide is toxic (or extremely toxic) to birds.
This chemical is known to leach through soil into ground
water under certain conditions as a result of agricultural use. Use of
this chemical in areas where soils are permeable, particularly where
the water table is shallow, may result in ground-water contamination.
This chemical demonstrates the properties and
characteristics associated with chemicals detected in ground water. Use
of this chemical in areas where soils are permeable, particularly where
the water table is shallow, may result in ground-water contamination.
EPA believes it is appropriate to consider only realistic
environmental exposure scenarios. For example, it is possible that the
label of a pesticide product for indoor use could have one of the
environmental hazard statements, such as ``This pesticide is toxic to
fish.'' In this case, the chance of fish in the environment being
exposed if the container fails is very small, since the container would
most likely be stored and the pesticide used inside. Therefore, in the
regulatory option being considered, the environmental hazard criterion
would apply only to pesticides intended for outdoor use.
EPA is considering specifying several environmental hazard criteria
in addition to the label statements listed earlier. Some pesticides are
classified as restricted use for environmental or ecological reasons.
EPA is considering adding this criterion (classification as restricted
use for environmental or ecological reasons) to help distinguish the
higher-risk pesticides in terms of environmental risk. However, EPA
believes that pesticides that meet this criterion would most likely
have at least one of the specified environmental hazard statements on
their labels. EPA is also considering adding a criterion for
``biological activity'' or phytotoxicity to include pesticides that are
applied at low application rates. Low application rate pesticides may
not trigger the container size criterion since only small volumes are
used. However, a small release of a low application rate herbicide may
still pose significant risks in the environment, because such
pesticides are designed and intended to be effective in low doses.
These potential criteria are not included in the draft regulatory
language in this document, although EPA may decide to include one or
both of them in the final rule.
3. Container size criterion. In addition, EPA is concerned that
even products that don't meet any of the higher-toxicity criteria may
pose a significant risk if they are present in large enough quantities.
Therefore, EPA is also considering container size as a criterion for
defining the scope of the container standards. EPA is currently
considering a size criterion of 5.0 liters (1.3 gallons) for containers
holding liquid formulations and 5.0 kilograms (11.0 pounds) for
containers holding solid formulations. These sizes were selected to be
consistent with the limited quantity exceptions in the DOT Hazardous
Materials Regulations (HMR) in 49 CFR parts 171-180. As described in
Unit V of this document, many commenters strongly urged EPA to be
consistent with the DOT HMR which would include adopting the DOT
limited quantity exceptions. Therefore, EPA believes it is appropriate
to base a container size criterion on the package sizes delineated in
the DOT limited quantity exceptions.
4. General discussion. The flow chart below depicts the changes
being considered for the scope of the container standards for
pesticides other than antimicrobial pesticides that are eligible for
exemption. The changes to the scope and applicability provisions would
be the same for nonrefillable containers (in proposed subpart F) and
refillable containers (in proposed subpart G). Under the approach being
considered for the general scope (and as shown in the flow chart), the
container standards would not apply to manufacturing use products, as
proposed in 1994. Regarding products other than manufacturing use
products, if the pesticide product meets at least one of the criteria
being considered (i.e., Toxicity Category I, Toxicity Category II,
greater than (or equal to) the minimum container size, or outdoor use
products with one of the label environmental hazard statements) then
the product would be subject to the container standards. If the product
did not meet any one of these criteria, it would not be subject to the
container standards. Potential alternative regulatory text that is
being considered for the final rule is provided in Unit VII of this
document.
BILLING CODE 6560-50-F
[[Page 56923]]
[GRAPHIC] [TIFF OMITTED] TP21OC99.002
BILLING CODE 6560-50-C
EPA believes that it has authority to reduce the scope of these
regulations. FIFRA section 19(e) requires EPA to promulgate regulations
that promote the safe storage and disposal of pesticides. FIFRA section
19(f) requires EPA to promulgate regulations prescribing procedures and
standards for the removal of pesticides from containers prior to
disposal, but provides the EPA with much discretion in accomplishing
this goal. In addition, FIFRA section 25(b) allows EPA to exempt (by
regulation) any pesticide from the requirements of FIFRA if EPA
determines that pesticide to be of a character which is unnecessary to
be subject to FIFRA in order to carry out the purposes of FIFRA.
Under the changes being considered to the scope of the container
rule, the standards would not apply to small containers holding
pesticides in Toxicity Category III or IV that don't have any of the
environmental hazard statements on their labels or that have at least
one of the environmental hazard statements but are not intended for
outdoor use. EPA believes it is appropriate to exclude these groups of
pesticides and containers from regulation because the relatively small
risk to humans and the environment if the container fails, due to their
low toxicity, small quantity and/or limited exposure to the
environment, is not commensurate with the costs of imposing the
standards on these pesticides and containers.
These potential changes to the scope of the proposed rule are being
considered only for the container design and residue removal standards
in subparts F and G -- not for the proposed modifications to the 40 CFR
part 156 label provisions. EPA believes that it is appropriate to have
container cleaning and disposal instructions on the labels of all
pesticides because of safety and environmental protection
considerations for recycling operations. It is necessary for pesticide
containers to be properly emptied and cleaned prior to being recycled
to protect workers who handle the recyclable material and to prevent
releases of pesticides to the environment. Because pesticide containers
from all segments of the pesticide industry are currently being
recycled, container cleaning and disposal instructions are needed on
the labels of all pesticides. EPA believes that FIFRA sections 19(e)
and (f) provide the Agency with the authority to make this
determination.
D. Request for Comments
EPA solicits comments on the potential modifications to the scope
and applicability of the container standards. In addition to any
general comments on the approach being considered, EPA requests
comments on the following specific issues. (1) Is it appropriate to
apply the container standards only to the higher-risk pesticides? (2)
Are the criteria being considered by EPA to distinguish between higher-
risk and lower-risk pesticides appropriate? (3) In particular, is
container size a reasonable factor to consider and, if so, is the
suggested size criterion appropriate or should EPA adopt a different
size limit? (4) Should alternative or additional environmental hazard
criteria, such as those described in Unit III.C.2 of this document be
considered? (5) Are there certain container types (e.g., glass
containers) that are sufficiently unsafe that such container types
should be regulated for all pesticides? (6) Should the potential
modifications to the scope be made to the container-related provisions
only or should the changes also be made to the proposed label
standards?
IV. Antimicrobial Exemption
A. Statutory Background
The Food Quality Protection Act (FQPA) of 1996, Public Law No. 104-
170, amended section 19 of FIFRA to exempt certain types of
antimicrobial pesticides from the pesticide container provisions under
certain circumstances. Specifically, FQPA added the following to FIFRA
section 19(h):
A household, industrial, or institutional antimicrobial product
that is not subject to regulation under the Solid Waste Disposal
[[Page 56924]]
Act (42 U.S.C. 6901 et seq.) shall not be subject to the provisions
of subsections (a), (e), and (f), unless the Administrator
determines that such product must be subject to such provisions to
prevent an unreasonable adverse effect on the environment.
Since this language was added after the pesticide container and
containment rule was proposed, EPA believes it is appropriate to
solicit public comment on the applicability of this provision to the
proposed container regulations. In addition, EPA must interpret the
antimicrobial exemption provision to answer two broad questions. First,
what is the scope of ``household, industrial, or institutional
antimicrobial product[s] that [are] not subject to regulation under the
Solid Waste Disposal Act''? Second, which ``product[s] must be subject
to [the container] provisions to prevent an unreasonable adverse effect
on the environment''?
B. Scope of the Antimicrobial Exemption
1. Regulatory option under consideration. EPA believes that a
``household, industrial, or institutional antimicrobial product that is
not subject to regulation under the Solid Waste Disposal Act'' is a
pesticide product that meets all of the following criteria. (i) The
product meets the definition of ``antimicrobial pesticide'' in section
2(mm) of FIFRA; (ii) the product is classified in at least one of the
following antimicrobial product use categories: (a) food handling/
storage establishments premises and equipment; (b) commercial,
institutional, and industrial premises and equipment; (c) residential
and public access premises; (d) medical premises and equipment; (e)
materials preservatives; (f) industrial processes and water systems;
(g) antifouling coatings; (h) wood preservatives; or (i) swimming
pools; and (iii) the product is not subject to regulation under the
Resource Conservation and Recovery Act as a hazardous waste when it
becomes a waste.
2. Discussion. The first criterion above requires an
``antimicrobial product'' to be an ``antimicrobial pesticide,'' as
defined in FIFRA. Section 2(mm) of FIFRA provides the following
definition for an antimicrobial pesticide.
(1) IN GENERAL.--The term `antimicrobial pesticide' means a
pesticide that--
(A) is intended to-- (i) disinfect, sanitize, reduce, or
mitigate growth or development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes or systems,
surfaces, water, or other chemical substances from contamination,
fouling, or deterioration caused by bacteria, viruses, fungi,
protozoa, algae, or slime; and
(B) in the intended use is exempt from, or otherwise not subject
to, a tolerance under section 408 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 346a and 348) or a food additive regulation
under section 409 of such Act.
(2) EXCLUDED PRODUCTS.--The term `antimicrobial pesticide' does
not include --
(A) a wood preservative or antifouling paint product for which a
claim of pesticidal activity other than or in addition to an
activity described in paragraph (1) is made;
(B) an agricultural fungicide product; or
(C) an aquatic herbicide product.
(3) INCLUDED PRODUCTS.--The term `antimicrobial pesticide' does
include any other chemical sterilant product (other than liquid
chemical sterilant products exempt under subsection (u)), any other
disinfectant product, any other industrial microbiocide product, and
any other preservative product that is not excluded by paragraph
(2).
Because this is a very complex definition, EPA considered using a
more straightforward definition for ``antimicrobial product.''
Specifically, EPA considered defining ``antimicrobial product'' to be
any product covered under section (1)(A) of the definition of
``antimicrobial pesticide'' in FIFRA section 2(mm), without taking the
remainder of that definition into account. However, EPA rejected this
approach because the Agency is unaware of evidence that indicates
Congress intended ``antimicrobial products'' to be different than
``antimicrobial pesticides.'' Additionally, EPA believes that
distinguishing between ``antimicrobial products'' and ``antimicrobial
pesticides'' could be confusing to regulators and the regulated
industry and could pose enforcement problems. If a pesticide product is
not included in the definition of antimicrobial pesticide (e.g., if it
is excluded by paragraph (2) of the definition), it is not eligible for
the antimicrobial product exemption from the container standards and,
thus, is subject to the general scope criteria as discussed in Unit III
of this document.
The second criterion for defining the scope of the antimicrobial
exemption states that a pesticide product is a ``household, industrial,
or institutional'' product if it is classified in at least one of nine
specified antimicrobial product use categories.
In response to other FQPA provisions pertaining to antimicrobial
pesticides, EPA is developing regulations on the registration of
antimicrobial pesticides and the associated data requirements. In its
proposal on data requirements (that would amend 40 CFR part 158), EPA
intends to categorize all antimicrobial uses into one of the following
12 use categories. All currently registered antimicrobial use patterns
are included in one of these larger use classifications for data
requirement purposes, but EPA has not to date classified the existing
use patterns in this organized fashion.
Agricultural premises and equipment
Food handling/storage establishments premises and
equipment
Commercial, institutional, and industrial premises and
equipment
Residential and public access premises
Medical premises and equipment
Human drinking water systems
Materials preservatives
Industrial processes and water systems
Antifouling coatings
Wood preservatives
Swimming pools
Aquatic areas
The list of the 12 use categories with all of the appropriately
classified use sites is included in the docket (Ref. 3).
In today's document, EPA is considering the approach of identifying
nine of these use categories to identify ``household, industrial, or
institutional'' antimicrobial products. Specifically, EPA believes that
the following nine use categories generally fit within the common
understanding of household, industrial and institutional uses:
Food handling/storage establishments premises and
equipment
Commercial, institutional, and industrial premises and
equipment
Residential and public access premises
Medical premises and equipment
Materials preservatives
Industrial processes and water systems
Antifouling coatings
Wood preservatives
Swimming pools
The other three categories, which are listed below, would not be
considered household, industrial, or institutional uses because they
fall outside the common understanding of these uses:
Agricultural premises and equipment
Human drinking water systems
Aquatic areas
EPA considered developing definitions for household, industrial,
and institutional use, but rejected this approach because of the
difficulty in distinguishing among these pesticide market sectors. EPA
believes that relying on the antimicrobial product use categories in
the antimicrobial registration data requirements rule to distinguish
between ``household, industrial, and institutional antimicrobial
products'' and all others
[[Page 56925]]
for the purposes of the container rule will offer a consistent approach
to the definitional issues involved with this criterion. There may be
implementation issues with this approach since it is unlikely that the
pesticide container and containment rule and the rule on antimicrobial
pesticide registration data requirements will be finalized at the same
time. However, EPA will coordinate between these rules to ensure
consistency and proper notice to the public on the issue of
antimicrobial product use categories.
The third criterion for defining the scope of the antimicrobial
exemption establishes that a pesticide product ``is not subject to
regulation under the Solid Waste Disposal Act'' if it is not subject to
regulation under the Resource Conservation and Recovery Act as a
hazardous waste when it becomes a waste. The Solid Waste Disposal Act
(SWDA) is the Federal waste management statute, which is commonly
referred to as the Resource Conservation and Recovery Act (RCRA), 42
U.S.C. 6901 to 6992k. (Technically, RCRA was the name of the law that
extensively amended the SWDA in 1976.) The terms ``RCRA'' and ``SWDA''
are used synonymously in this document.
EPA believes that the intent of the statutory language in question
-- ``that is not subject to regulation under the SWDA'' -- is to
include in the antimicrobial exemption household, industrial, or
institutional antimicrobial products that are not subject to regulation
under RCRA as hazardous wastes when they become wastes. If a household,
industrial, or institutional antimicrobial product would be classified
as a hazardous waste when it becomes a waste (either by being on one of
the RCRA hazardous waste lists or by meeting one of the hazardous waste
characteristics), then the product would not be eligible for the FIFRA
section 19(h) exemption. An initial review showed that none of the
``listed hazardous waste pesticides'' are antimicrobial pesticides. EPA
believes that most household, industrial, and institutional
antimicrobial products would not be subject to regulation under RCRA as
hazardous wastes when they become wastes and, therefore, would be
eligible for the FIFRA section 19(h) exemption.
EPA considered several other interpretations of the SWDA reference,
but rejected them because the group of pesticides that would be exempt
did not appear to be an accurate or realistic representation of
Congress's intent. One alternative interpretation is based on the fact
that household, industrial, or institutional antimicrobial products are
products and not wastes. Pesticide products are regulated by FIFRA;
pesticide wastes are regulated by RCRA. Under this interpretation, no
household, industrial, or institutional antimicrobial products would or
could ever be subject to regulation under the Solid Waste Disposal Act,
and, therefore, they all would be eligible for the FIFRA section 19(h)
exemption. However, EPA believes that the scope of the exemption under
this interpretation is too broad to realistically represent the
Congressional intent.
Another alternative would be to include in the exemption only
household, industrial, or institutional antimicrobial products that are
not subject to any regulation under RCRA (i.e., as solid waste or
hazardous waste) when they become wastes. However, this interpretation
would appear to eliminate the exemption altogether, because all
antimicrobial product waste (including liquids) would fit into the RCRA
regulatory definition of ``solid waste.'' Therefore, all of the
household, industrial, or institutional antimicrobial products would be
subject to regulation under the Solid Waste Disposal Act. Under this
interpretation, none of these products would be eligible for the FIFRA
section 19(h) exemption. It seems reasonable to presume that Congress
did not intend this result, as it would clearly nullify the exception
that Congress had crafted for antimicrobial pesticides. It would seem
to be an absurd interpretation that Congress intended this section to
have no effect. Further, it is reasonable to presume, given the
structure and regulatory history of SWDA, that Congress intended its
reference to regulation under SWDA to mean regulation as a hazardous
waste under SWDA. Though SWDA does provide for regulation of solid
waste (in particular, restrictions on ``open dumping''), hazardous
waste has been subject to much more extensive regulation and has been
to a significant degree the focus of Federal regulation under SWDA.
(Ref. 4) It is therefore likely that the most reasonable interpretation
of this provision is to interpret ``subject to regulation under the
Solid Waste Disposal Act'' to mean ``subject to regulation as a
hazardous waste under the Solid Waste Disposal Act.''
In summary, EPA believes that the scope of ``household, industrial,
or institutional antimicrobial products that are not subject to
regulation under the Solid Waste Disposal Act'' includes pesticide
products that: (1) Meet the definition of antimicrobial pesticide in
FIFRA section 2(mm); (2) fall within one of the specified antimicrobial
product use categories; and (3) are not subject to regulation under
RCRA as hazardous wastes when they become wastes. Throughout the
remainder of this document, these pesticides are referred to as
``eligible antimicrobial pesticides,'' i.e., those pesticides that are
eligible for the antimicrobial exemption.
3. Request for comments. EPA requests comments on this
interpretation of the statutory antimicrobial exemption. In addition to
general comments, EPA solicits comments on the following specific
questions.
i. Is it appropriate to adopt the statutory definition for
``antimicrobial pesticide'' to define ``antimicrobial product'' for the
purposes of the pesticide container and containment rule? If an
alternative definition of antimicrobial product should be adopted,
please explain why and provide an alternative definition.
ii. Is it appropriate to rely on antimicrobial product use
categories developed for data requirement purposes to distinguish among
household, industrial, and institutional antimicrobials and all others
for container regulatory purposes or should EPA adopt another approach
such as defining each of these pesticide use sectors?
iii. Is EPA's interpretation of the statutory reference to the SWDA
appropriate or should EPA adopt an alternative interpretation?
In addition, EPA requests information about which antimicrobial
pesticides, if any, are subject to regulation as hazardous wastes under
RCRA when they become wastes.
C. Preventing Unreasonable Adverse Effects on the Environment
1. Regulatory option under consideration. Under the regulatory
option being considered, EPA has determined that eligible antimicrobial
products classified in Toxicity Category I must be subject to a
substantial majority of the container provisions to prevent an
unreasonable adverse effect on the environment. As discussed in greater
detail below, eligible Toxicity Category I antimicrobial products would
be subject to all of the nonrefillable and refillable container
standards with two exceptions. First, eligible Toxicity Category I
antimicrobial products would be exempt from the nonrefillable residue
removal standard. Second, eligible Toxicity Category I antimicrobial
products that are used in swimming pools would be exempt from certain
refillable container standards (including, but not limited to serial
[[Page 56926]]
number markings, one-way valves or tamper-evident devices, and some
recordkeeping) that would greatly interfere with the current wide use
of refillable containers in that industry segment.
2. Description of options. EPA considered a wide range of options
for determining which eligible antimicrobial products must be subject
to the container provisions to prevent an unreasonable adverse effect
on the environment. The four options that EPA preliminarily believes to
be the most appropriate are described in Units IV.C.2.i - iv of this
document. The options are listed in the order of how many eligible
antimicrobial products would be exempt, where option 1 would exempt the
most and option 4 would exempt the least. Options 2 and 3 would exempt
the same number of products, but would apply different sets of
standards to the products that would be included.
This section of the document is intended to provide a brief summary
of the options. The following unit provides a comparison, analysis, and
more detailed explanation of the options and explains why option 3 is
put forth as EPA's preferred option.
i. Option 1. Exempt all eligible antimicrobials, but include a
provision to require a specific product or group of products to comply
with the container regulations if a problem becomes evident. Eligible
antimicrobials (i.e., household, industrial, or institutional
antimicrobial products that are not subject to regulation under the
Solid Waste Disposal Act) would be exempt from the pesticide container
regulations, unless EPA specifically includes the antimicrobial product
or products. EPA could make a case-by-case determination that a
specific product or group of products must be subject to the container
standards to prevent an unreasonable adverse effect on the environment.
The regulations could include a provision such as the following to
allow such case-by-case decisions to be made: ``EPA may determine that
an antimicrobial product or products must comply with the container
standards. EPA may consider evidence such as field studies, use
history, accident data, monitoring data, or other pertinent evidence in
deciding whether the product must comply with the container standards
to prevent an unreasonable adverse effect on the environment.''
The overall criterion that would be used to make product-specific
inclusion decisions is that the antimicrobial product would cause an
unreasonable adverse effect on the environment unless it complied with
the container standards. EPA would consider requiring a specific
antimicrobial product to comply with the container standards in
situations where EPA became aware of situations such as, but not
limited to: (1) An antimicrobial product with a non-negligible number
of containers that leaked or otherwise accidentally released pesticide
to the environment; (2) an antimicrobial product with a non-negligible
number of container-related documentable exposures to persons using the
product, particularly if there are significant health effects to the
pesticide users; or (3) the use of refillable containers to distribute
antimicrobial products has expanded into new market segments and use
sites, where the safeguards of the proposed regulations are necessary
to prevent exposure and unreasonable risks to pesticide users and human
health and the environment in general. In situations such as these, EPA
could decide to require just the specific product in question to comply
with the container regulations. However, EPA could also require similar
products distributed in similar containers to comply with the container
standards if the Agency could reasonably expect the same problems from
these other antimicrobial products.
A provision such as this could be added to any of the other options
to account for new information about problems with specific products
that might not be included by the general criteria. In order to
simplify this discussion, EPA chose not to add such a provision to
create a ``suboption'' for each of the following options. In the final
rule, however, EPA may decide to add a ``case-by-case provision'' to
one of the following options.
ii. Option 2. Subject eligible antimicrobials classified in
Toxicity Category I to all of the container regulations. Eligible
antimicrobials classified in Toxicity Category I would be included in
the pesticide container regulations. Other eligible antimicrobials
(i.e., those in Toxicity Categories II, III, and IV) would be exempt
from the container regulations. Under this option, EPA would make a
determination that eligible antimicrobials classified in Toxicity
Category I must be subject to all of the container regulations to
prevent an unreasonable adverse effect on the environment.
iii. Option 3. Subject eligible antimicrobials classified in
Toxicity Category I to a subset of the container regulations. This
option is similar to option 2 in that eligible antimicrobials
classified in Toxicity Category I would be included in the pesticide
container regulations and other eligible antimicrobials (i.e., those in
Toxicity Categories II, III, and IV) would be exempt from the container
standards. EPA would make an unreasonable adverse effects determination
similar to that in option 2. Under this option, however, only a subset
of the container standards would apply to eligible antimicrobial
pesticides in Toxicity Category I.
Specifically, eligible Toxicity Category I antimicrobial products
would be subject to all of the nonrefillable container standards except
for the residue removal standard (which was proposed as Sec. 165.104).
Also, eligible Toxicity Category I antimicrobial products that are used
in swimming pools would be exempt from certain refillable container
standards (including, but not limited to serial number markings, one-
way valves or tamper-evident devices, and some recordkeeping). All
other eligible Toxicity Category I antimicrobial products would have to
comply with all of the refillable container standards. The full list of
requirements that would apply under this approach is provided in the
potential alternative regulatory text in Unit VII of this document. The
exemptions from specific requirements are discussed in more detail in
Unit IV.C.3 of this document.
iv. Option 4. Apply the scope criteria being considered for other
pesticides (as discussed in Unit III of this document) to eligible
antimicrobials. Eligible antimicrobials would be subject to the same
exclusion/inclusion criteria as other pesticides, according to the
modifications being considered for the scope of the container
regulations. As discussed in Unit III of this document, EPA is
considering criteria based on: (a) Classification in Toxicity
Categories I or II; (b) container size; and (c) environmental hazard
statements on the labels of outdoor pesticides to distinguish between
higher-risk and lower-risk pesticides. Under this approach, EPA would
make a determination that eligible antimicrobials that meet any of the
criteria must be subject to the container regulations to prevent an
unreasonable adverse effect on the environment.
3. Discussion. One issue regarding these options is whether EPA can
set general criteria for making an unreasonable adverse effect
determination or if such a determination must be made on a case-by-case
basis. EPA believes that the statutory language ``unless the
Administrator determines that [an eligible antimicrobial] product must
be subject to [the container]
[[Page 56927]]
provisions to prevent an unreasonable adverse effect on the
environment'' does not preclude the adoption of either approach
(general criteria or a case-by-case decision). Section 19(h) provides
the Agency with considerable flexibility to make a reasonable
interpretation of the statutory language. EPA believes that the Agency
can set general criteria and/or make case-by-case decisions in making
unreasonable adverse effect determinations.
Another issue regarding these options is estimating how many
products would be included in the regulations by each of the options.
(Ref. 5) EPA estimates that there are about 5,000 registered
antimicrobial end-use products being marketed in the United States.
While not all of these products would be household, industrial, or
institutional antimicrobial products that are not subject to regulation
under the SWDA, this analysis will use 5,000 products as a reasonable
upper limit. To estimate the percentage of eligible antimicrobial
pesticides classified in Toxicity Categories I and II, EPA analyzed
information in an Office of Pesticide Programs data base. Based on this
analysis, EPA estimates that about 70% of eligible antimicrobial
products are classified in Toxicity Category I and an additional 15%
are classified in Toxicity Category II. The number and percent of
eligible antimicrobial products that would have to comply with the
container standards under the four options is summarized in the
following table 2.
Table 2.-- Summary of Options for Exempting Certain Antimicrobial Products
----------------------------------------------------------------------------------------------------------------
Products Included Products Exempted
Option Number Description ----------------------------------------------------------
Number Percent Number Percent
----------------------------------------------------------------------------------------------------------------
Option 1........................ Exempt all except some > 0 most (< 5,000)="">< 100="" case-by-case.="" option="" 2........................="" include="" toxicity="" 3,500="" 70="" 1,500="" 30="" category="" i.="" option="" 3........................="" include="" toxicity="" 3,500="" 70="" 1,500="" 30="" category="" i.="" option="" 4........................="" include="" toxicity="" 4,250="" -="" 4,500="" 85="" -="" 90="" 500="" -="" 750="" 10="" -="" 15="" category="" i="" &="" ii,="" container="" size,="" environmental="" criteria.="" ----------------------------------------------------------------------------------------------------------------="" under="" option="" 1,="" eligible="" antimicrobials="" would="" be="" exempt="" from="" the="" pesticide="" container="" regulations,="" unless="" epa="" made="" a="" case-by-case="" determination="" that="" a="" specific="" product="" or="" group="" of="" products="" must="" be="" subject="" to="" the="" container="" standards="" to="" prevent="" an="" unreasonable="" adverse="" effect="" on="" the="" environment.="" this="" option="" would="" exempt="" nearly="" all="" eligible="" antimicrobials="" from="" the="" container="" rule.="" therefore,="" this="" option="" would="" have="" the="" lowest="" economic="" costs="" since="" the="" economic="" costs="" of="" the="" rule="" are="" directly="" related="" to="" the="" number="" of="" products="" that="" would="" be="" regulated.="" epa="" rejected="" option="" 1="" because="" the="" agency="" believes="" that="" the="" risk="" of="" exempting="" nearly="" all="" eligible="" antimicrobial="" products="" is="" too="" high.="" under="" this="" approach,="" few,="" if="" any,="" antimicrobial="" pesticides="" would="" initially="" be="" subject="" to="" these="" regulations,="" even="" those="" antimicrobial="" pesticides="" that="" are="" in="" toxicity="" category="" i.="" a="" high="" percentage,="" about="" 70%,="" of="" eligible="" antimicrobials="" are="" classified="" in="" toxicity="" category="" i="" (mostly="" because="" they="" meet="" the="" criteria="" for="" eye="" and/or="" skin="" effects).="" this="" is="" a="" significantly="" larger="" percentage="" than="" for="" other="" segments="" of="" the="" pesticide="" industry.="" based="" on="" an="" analysis="" of="" information="" in="" an="" office="" of="" pesticide="" programs="" data="" base="" (ref.="" 5),="" epa="" estimates="" that="" about="" 20%="" of="" agricultural="" pesticides="" are="" classified="" in="" toxicity="" category="" i="" (with="" an="" additional="" 15%="" in="" toxicity="" category="" ii)="" and="" about="" 10%="" of="" pesticides="" for="" forestry="" and="" ornamental="" turf="" and="" plants="" are="" classified="" in="" toxicity="" category="" i="" (with="" an="" additional="" 15%="" in="" toxicity="" category="" ii).="" this="" information="" is="" summarized="" in="" the="" following="" table="" 3.="" table="" 3.--="" comparison="" of="" highly="" toxic="" products="" in="" different="" pesticide="" market="" segments="" ------------------------------------------------------------------------="" percentage="" of="" products="" --------------------------------="" pesticide="" industry="" segment="" toxicity="" toxicity="" toxicity="" category="" category="" category="" i="" ii="" i="" or="" ii="" ------------------------------------------------------------------------="" forestry="" and="" ornamental="" turf="" and="" plants="" 10="" 15="" 25="" agricultural="" crops.....................="" 20="" 15="" 35="" eligible="" antimicrobials................="" 70="" 15="" 85="" ------------------------------------------------------------------------="" in="" addition,="" the="" large="" quantity="" of="" antimicrobial="" products="" used="" each="" year="" supports="" including="" some="" of="" these="" products="" within="" the="" scope="" of="" the="" container="" requirements.="" the="" following="" table="" 4="" summarizes="" the="" u.s.="" usage="" of="" different="" types="" of="" pesticides="" in="" 1995.="" (ref.="" 6)="" according="" to="" this="" information,="" eligible="" antimicrobial="" pesticides="" account="" for="" over="" 40%="" of="" all="" pesticides="" used="" in="" 1995="" (on="" a="" weight="" basis).="" table="" 4.--="" pesticide="" usage="" in="" the="" united="" states="" in="" 1995="" ----------------------------------------------------------------------------------------------------------------="" quantity="" of="" pesticide="" used="" -------------------------------------------------="" type="" of="" pesticide="" millions="" of="" pounds="" active="" ingredient="" percent="" ----------------------------------------------------------------------------------------------------------------="" non-antimicrobial="" pesticides="" conventional="" pesticides.......................................="" 973="" 21="" [[page="" 56928]]="" sulfur,="" petroleum="" (oil,="" distillates,="" etc.),="" sulfuric="" acid="" and="" 249="" 6="" other="" miscellaneous="" chemicals="" used="" as="" pesticides.............="================================================" subtotal....................................................="" 1222="" 27="" eligible="" antimicrobial="" pesticides="" wood="" preservatives="">1.......................................... 718 16
Specialty biocides by end use.................................
Swimming pools, spas, individual water treatment 2.......... 175 4
Disinfectants and sanitizers 3.............................. 32 1
Other 4..................................................... 50 1
Chlorine/hypochlorites........................................
Bleaching disinfectant and pools............................ 925 20
=================================================
Subtotal.................................................... 1,900 42
Non-eligible antimicrobial pesticides 5
Chlorine/hypochlorites........................................
Disinfection of potable and waste water.................... 1,390 31
=================================================
Subtotal.................................................... 1,390 31
-------------------------------------------------
TOTAL 6................................................... 4,512 100
----------------------------------------------------------------------------------------------------------------
\1\ Includes water and air borne preservatives and creosote/coal tar/petroleum preservatives. The original
report (Ref. 6) also included 7 million pounds of fire retardants in the category of wood preservatives. The 7
million pounds of fire retardants are not included as wood preservatives in this table.
\2\ Specialty biocides only. Does not include hypochlorite or chlorine consumption, which is reported
separately.
\3\ Includes industrial/institutional applications and household cleaning products. Specialty biocides only.
Does not include hypochlorite or chlorine consumption, which is reported separately.
\4\ Includes biocides for adhesives and sealants, leather, synthetic latex polymers, metalworking fluids, paints
and coatings, petroleum products, plastics, and textiles. Does not include: hospital and medical antiseptics,
food and feed preservatives, and cosmetics/toiletries. These latter types of usage are not included (in Ref.
6), as they are regulated largely by the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic
Act rather than FIFRA. The FDA and EPA share regulatory responsibilities over some of the specialty biocide
usage reported in the table.
\5\ This category of chlorine/hypochlorites usage is not considered a ``household, industrial, or institutional
use.'' See the discussion of antimicrobial use product use categories in Unit IV.B.2 of this document.
\6\ The total is 7 millions pounds less than in Ref. 6 because 7 million pounds of fire retardants were removed
from the original estimate of wood preservatives. See footnote 1.
Because most eligible antimicrobial products pose a high (Toxicity
Category I) or relatively high (Toxicity Category II) hazard to humans
and the large quantity of eligible antimicrobials used annually (over
40% of pesticides used in 1995, based on pounds of active ingredient),
EPA believes that it is appropriate and necessary to require certain
eligible antimicrobial products to comply with the container standards
to prevent unreasonable adverse effects on the environment.
In option 2, EPA would require eligible antimicrobial products in
Toxicity Category I to comply with the container standards. EPA
believes it is appropriate to include these products because they
present the highest hazards to humans. Subjecting these highest-risk
pesticides to the container standards that are intended to ensure the
safe storage, use, refill/reuse and disposal of pesticides would
provide benefits, by lowering the overall risk to man and the
environment, that would not be obtained by option 1.
However, EPA prefers option 3, a variation of option 2, because it
offers some cost and environmental benefits over option 2. Option 3
would exempt eligible antimicrobial products in Toxicity Category I
from certain container requirements.
To ease the economic impact on registrants of antimicrobial
pesticides, option 3 would exempt eligible antimicrobial products from
the nonrefillable residue removal standard, which was proposed as
Sec. 165.104. While representatives from all sectors of the pesticide
industry commented that the proposed nonrefillable residue removal
standard would be a burdensome and costly requirement, the
antimicrobial industry pointed out some characteristics of their
containers and products that pose particular difficulties with respect
to residue removal. Commenters stated that antimicrobial products tend
to have extremely low active ingredient concentrations, which makes it
difficult to make the measurements needed to determine compliance with
the proposed standard. In addition, commenters said that antimicrobial
formulations often contain ingredients that create foam when containers
are shaken during the triple rinsing procedure, making it more
difficult to comply with the proposed residue removal standard. (Ref.
2) Based on the comments, EPA believes these problems are more
prevalent with antimicrobials than with other pesticides. EPA also
believes that the ``unreasonable adverse effect'' language of section
19(h), which requires review of costs and benefits, allows EPA more
flexibility to exempt antimicrobial pesticides from these requirements
than does the language in section 19(e) and (f) which is more directed
at risk. Therefore, under the regulatory approach under consideration,
eligible antimicrobial products would not have to comply with the
nonrefillable residue removal standard. Please note that EPA is
considering a range of modifications to the residue removal standard in
the final rule that take into account all of the comments on the
proposed standard. This document is not soliciting additional comments
on the proposed nonrefillable residue removal standard.
[[Page 56929]]
Another significant concern with the proposed rule that was raised
in the public comments was that the refillable container standards
posed many impediments to the extensive and successful use of
refillable containers that are currently used to distribute swimming
pool chemicals. The swimming pool chemical industry commented that the
following proposed requirements would require significant and costly
changes to the many refillable containers currently used: the serial
number marking; one-way valves or tamper-evident devices; relabeling
the container; and recordkeeping. (Ref. 2) EPA agrees that applying
these requirements to swimming pool pesticides would disrupt the
current refillable container system for swimming pool chemicals and
would probably cause the refillables to be replaced by millions of
single-use, nonrefillable containers. EPA believes that adding millions
of pounds of these nonrefillable containers to the waste stream is
inconsistent with the goals of section 19(e) of FIFRA, particularly
that the regulations facilitate the safe refill and reuse of
containers.
In addition, many of the proposed refillable container standards in
question are intended to minimize the possibility of cross-
contamination in refillable containers. Cross-contamination is less of
a concern for swimming pool pesticides than for agricultural pesticides
for several reasons. First, several commenters indicated that the
refillable containers in the swimming pool market are only used to
distribute sodium hypochlorite and not other kinds of antimicrobial
pesticides. (Ref. 2) Second, these antimicrobial pesticides are used on
the same site, i.e., swimming pools. EPA evaluates the risks posed by
swimming pool pesticides at the concentrations at which they are used.
Therefore, low levels of contamination from other swimming pool
chemicals would pose little additional risk to humans or the
environment because of the low concentrations and because the
contaminant is intended to be used in swimming pools. In other words,
the contaminant would not be applied to a site, pest, or crop for which
it wasn't intended, which could easily happen in an agricultural
setting. [Note: this does not exempt swimming pool chemicals from
complying with the product chemistry registration requirements and
related policies, including PR Notice 96-8 ``Toxicologically
Significant Levels of Pesticide Active Ingredients'' (Ref. 7)].
Therefore, this option would exempt swimming pool antimicrobial
pesticides from certain refillable container standards.
As described above in the discussion of options 2 and 3, EPA
believes it is appropriate to require eligible antimicrobial products
that are in Toxicity Category I to comply with most of the container
standards. About 70% of eligible antimicrobials would therefore have to
comply with most of the container standards. This might be considered
too large a percentage of antimicrobial products to be subject to the
regulation. Therefore, EPA is requesting comments on possible ways to
divide the eligible antimicrobial products in Toxicity Category I into
subcategories, for the purposes of regulating the products that pose
the highest risk and exempting the others. For example, the formulation
of the product may be related to the exposure of the handler when
dispensing a product from a container. For example, liquid formulations
may cause higher exposures than solid formulations due to dripping,
glugging, and leaking. In this example, EPA could choose to require
only liquid eligible antimicrobial products in Toxicity Category I to
comply with most of the container standards. EPA requests comments on
whether it is appropriate to divide eligible antimicrobial products in
Toxicity Category I into subcategories and, if so, EPA requests
suggestions on reasonable criteria for making such a distinction.
Option 4 would apply the same exclusion/inclusion criteria being
considered for other pesticides to eligible antimicrobials. As
discussed in Unit III of this document, EPA is considering criteria
based on (1) classification in Toxicity Categories I or II; (2)
container size; and (3) environmental hazards to distinguish between
higher-risk and lower-risk pesticides. Subjecting a larger group of
higher-risk pesticides to the container standards would provide more
benefits -- by further lowering the overall risk to man and the
environment -- than for options 2 and 3. However, EPA rejected option 4
mainly because the Agency believes that the FQPA amendment to FIFRA
section 19(h) indicates a Congressional intent for EPA to regulate
eligible antimicrobial products differently than all other pesticide
products. In particular, the standard set for subjecting antimicrobial
products to the container standards by FIFRA section 19(h) is ``to
prevent an unreasonable adverse effect on the environment.'' On the
other hand, the mandates in FIFRA sections 19(e) and (f) establish a
level of ``safety,'' e.g., ``safe storage and disposal'' and ``safe
use.'' In addition, Congress's revision to section 19(h) indicates that
Congress was particularly concerned about the economic impacts of
section 19(e) and (f) on the manufacture and use of antimicrobial
pesticides. Therefore, EPA believes that Congress intended that
eligible antimicrobial products should not be regulated unless there is
an extremely serious risk to humans or the environment if exposed
during a container incident, as there would be for Toxicity Category I
products. EPA believes a Toxicity Category I product would pose a
serious risk in such a situation regardless of whether it is classified
in Toxicity Category I because of its systemic toxicity, e.g., oral or
dermal LD50 or inhalation LC50, or because of its
eye and/or skin effects.
Because of the many questions raised by the statutory antimicrobial
exemption, it is instructive to review the approach EPA is considering
to implement this exemption. The following flow chart depicts EPA's
potential approach for implementing the antimicrobial exemption as
discussed above.
BILLING CODE 6560-50-F
[[Page 56930]]
[GRAPHIC] [TIFF OMITTED] TP21OC99.003
BILLING CODE 6560-50-C
EPA is interpreting the antimicrobial pesticide exemption to be an
exemption from the container design and residue removal standards in
proposed subpart F for nonrefillable containers and proposed subpart G
for refillable containers. On the other hand, EPA does not intend to
exempt eligible antimicrobials from the proposed container-related
labeling requirements. EPA believes that container cleaning and
disposal instructions should be included on the labels of all
pesticides. As described in Unit III.C.4 of this document, it is
necessary for pesticide containers to be properly emptied and cleaned
prior to being recycled to protect workers who handle the recyclable
material and to prevent releases of pesticides to the environment.
Because containers from all segments of the pesticide industry,
including eligible antimicrobial products, are currently being
recycled, container cleaning and disposal instructions are needed on
the labels of all pesticides. EPA believes that section 3 of FIFRA
provides the Agency with the authority to require cleaning and disposal
instructions on the labels of eligible antimicrobial pesticides.
Cleaning and disposal instructions were required on the labels of
eligible antimicrobial products as part of the directions for use
before FIFRA section 19(a) was added in 1988.
Decisions on the label requirements to be included in the final
rule will be made separately from the issues discussed in this
document. When making these decisions, EPA will consider all the
comments received during the initial public comment period, including
suggestions for alternative label instructions for household and
institutional pesticides. EPA is not soliciting further comments on the
specific label statements and standards proposed in 1994.
4. Request for comments. EPA requests comments on the approach
under consideration for determining that an eligible antimicrobial
product must be subject to the container standards to prevent an
unreasonable adverse effect on the environment, specifically, setting
classification in Toxicity Category 1 as a general criterion and
requiring these eligible antimicrobial pesticides to comply with a
subset of the container standards, as well as the other possible
approaches. EPA also solicits comments on the following specific
questions.
i. Should EPA establish general criteria for making this
determination (such as classification in Toxicity Category I) or should
such a
[[Page 56931]]
determination be made only on a case-by-case basis?
ii. If general criteria should be included, is the criterion being
considered appropriate or should EPA establish alternative or
additional general criteria, such as classification in Toxicity
Category II, a provision that accounts for environmental risk, and/or a
container size limit?
iii. Should EPA establish a detailed procedure for making a case-
by-case determination if there is a serious hazard problem related to
the containers of a specific antimicrobial product or group of
products? Are the examples of situations where EPA might make such a
determination, as discussed in Unit IV.C.2.i of this document,
reasonable? What other situations or criteria should EPA use in making
a decision to require a specific product to comply with the container
regulations?
iv. Is it appropriate to subject eligible antimicrobial products to
only a subset of the container requirements as set out in option 3?
v. Is it appropriate for EPA to divide eligible antimicrobial
products in Toxicity Category I into subcategories? If so, what would
be reasonable criteria for making such a distinction?
vi. Should eligible antimicrobial pesticides in Toxicity Categories
II, III, and IV be exempt from the container-related standards only,
i.e., should they be required to comply with the label standards? If
eligible antimicrobial pesticides in Toxicity Categories II, III, and
IV should be exempt from the label standards, please explain why these
containers do not need to be properly cleaned prior to being disposed
of or recycled.
D. Summary of Scope Modifications and the Antimicrobial Exemption
As described in Unit IV.C.3 of this document, EPA is considering
different criteria for antimicrobial pesticides than for all other
pesticides in terms of determining whether they would be subject to the
container standards. For antimicrobials that are ``eligible'' for
exemption, i.e., household, industrial, and institutional antimicrobial
pesticides that are not subject to RCRA, EPA is considering requiring
those that are classified in Toxicity Category I to comply with most of
the container standards. EPA has determined that eligible antimicrobial
pesticides that are classified in Toxicity Category I must be subject
to the container standards (other than the nonrefillable residue
removal standard and, for antimicrobial products used in swimming
pools, some of the refillable container standards) to prevent an
unreasonable adverse effect on the environment.
For all pesticides other than eligible antimicrobials, EPA is
considering applying the full set of container standards to those that
meet at least one of the following criteria: Toxicity Category I
classification, Toxicity Category II classification, container size
greater than or equal to 5.0 liters for liquids or 5.0 kilograms for
solids, or outdoor use pesticides that have one of the specified
environmental hazard statements on their label. EPA has determined that
pesticides that meet one of these criteria are higher-risk from a
container-release point of view and should be subject to the container
standards.
Because of the overlap in criteria being considered to delineate
the antimicrobial exemption and to define the general scope of the
container standards, it is useful to consider how these approaches
would mesh in the final rule. The following table 5 sets out which
pesticides would be included in the container regulations (for both
nonrefillable and refillable containers) and which would be exempt,
considering both the possible modifications to the scope and the
exemption for certain antimicrobial pesticides. Potential alternative
regulatory text that is being considered for the final rule is provided
in Unit VII of this document.
Table 5.--Summary of the Scope Modifications and the Antimicrobial
Exemption
------------------------------------------------------------------------
Conditions for
General Category Inclusion or Exemption Included or
1 Exempt? 2
------------------------------------------------------------------------
Manufacturing use products.... Any manufacturing use Exempt
product is exempt
from the regulations.
------------------------------------------------------------------------
Antimicrobial products that A product is included Included
are eligible for exemption in the regulations if
and that are end use products. it satisfies all of
the following
conditions:
It is an end
use product..
It is a
household,
industrial, or
institutional
antimicrobial product
that is not a
hazardous waste when
disposed..
It is in
Toxicity Category I..
[Note: Although these
products are included
in the regulations,
they are exempt from
certain specific
requirements, such as
the residue removal
standard for
nonrefillable
containers. Also,
swimming pool
pesticides in this
category are exempt
from some of the
refillable container
standards.].
-----------------------------------------
A product is exempt Exempt
from the regulations
if it satisfies all
of the following
conditions:
It is an end
use product..
It is a
household,
industrial, or
institutional
antimicrobial product
that is not a
hazardous waste when
disposed..
It is in
Toxicity Category II,
III, or IV..
------------------------------------------------------------------------
All other end use products, A product is included Included
which includes the following in the regulations if
three categories: (1) it satisfies both of
products that are not the following
antimicrobial products; (2) conditions:
antimicrobial products that It is in the
are not eligible for ``all other end use
exemption because they are products'' general
hazardous wastes when category..
disposed; and (3) It is in
antimicrobial products that Toxicity Category I
are not eligible for or II..
exemption because they are
not household, industrial, or
institutional antimicrobial
products.
------------------------------------------------------------------------
[[Page 56932]]
A product is included Included
in the regulations if
it satisfies all of
the following
conditions:
It is in the
``all other end use
products'' general
category..
It is in
Toxicity Category III
or IV..
It is in a
container whose
capacity is equal to
or greater than 5
liters (1.3 gallons)
or 5 kilograms (11
pounds)..
-----------------------------------------
A product is included Included
in the regulations if
it satisfies all of
the following
conditions:
It is in the
``all other end use
products'' general
category..
It is in
Toxicity Category III
or IV..
It is in a
container whose
capacity is less than
5 liters or 5
kilograms..
It has a
label with at least
one of the
environmental hazard
statements..
It has a
label that permits
outdoor use..
-----------------------------------------
A product is exempt Exempt
from the regulations
if it satisfies all
of the following
conditions:
It is in the
``all other end use
products'' general
category..
It is in
Toxicity Category III
or IV..
It is in a
container whose
capacity is less than
5 liters or 5
kilograms..
It has a
label with at least
one of the
environmental hazard
statements..
It has a
label that does not
permit outdoor use..
-----------------------------------------
A product is exempt Exempt
from the regulations
if it satisfies all
of the following
conditions:
It is in the
``all other end use
products'' general
category..
It is in
Toxicity Category III
or IV..
It is in a
container whose
capacity is less than
5 liters or 5
kilograms..
It has a
label without any of
the environmental
hazard statements..
------------------------------------------------------------------------
\1\ This column lists the conditions that determine whether a product is
included in the regulations or is exempt from the regulations.
\2\ This column provides a quick indication of whether the products
described in the previous column are included in the regulations or
are exempt from the regulations.
E. Request for Comments
EPA requests comments on the overall approach being considered for
implementing the antimicrobial exemption and for modifying the scope of
the container standards. EPA solicits comments on the complexity,
clarity, and appropriateness of the approach and on potential
alternatives. Also, EPA requests input on the potential impacts of the
approach being considered, i.e., how many pesticides would be excluded
and how many would be included.
V. Department of Transportation (DOT) Packaging Standards
A. Background on 1994 Proposal
The third issue being opened for comment in this document is a
regulatory approach being considered by EPA to adopt and refer to the
relevant portions of the DOT Hazardous Materials Regulations (HMR).
During the public comment period, EPA received many comments that
urged EPA to be consistent with the DOT regulations. Over 20
respondents, including individual companies and trade groups from the
pesticide registrant and container manufacturing industries, provided
commentary on the DOT HMR and the United Nations (U.N.) Recommendations
on the Transport of Dangerous Goods. All of the commenters agreed that
EPA should be consistent with the DOT HMR and the U.N. standards in
terms of definitions, requirements, and testing. Respondents argued
that such consistency would: (1) Facilitate compliance because the
industry is already familiar with the DOT and U.N. standards; (2)
eliminate the potential burden of complying with two different,
overlapping regulatory schemes; and (3) not establish additional trade
barriers. Most of the commenters on the DOT issue specifically favored
the use of DOT's packing group III criteria as the minimum standard for
pesticide products not regulated by DOT as hazardous materials. (Ref.
2)
EPA is considering incorporating this suggestion to change the
container regulations by adopting and referring to the DOT packing
group III criteria. While EPA discussed the DOT standards in some
detail in the preamble of the 1994 proposal, EPA did not specifically
discuss the approach of adopting and referring to the DOT HMR in the
final rule. Therefore, EPA is describing the approach under
consideration and soliciting comments in this document.
B. Regulatory Option Under Consideration
Pesticides that are classified as DOT hazardous materials would
continue to be packaged in accordance with the DOT HMR. Under the
regulatory approach being considered for the final rule, EPA would
cross-reference the HMR, so EPA could enforce these standards.
Pesticides that are not classified as DOT hazardous materials would be
required to be packaged in accordance with the specified packaging
design, construction, and marking standards that would apply to a DOT
packing group III material. All pesticides, regardless of DOT hazardous
material classification, would have to comply with additional
requirements for pesticides (``pesticide-specific requirements'') that
have no equivalents in the DOT HMR, e.g., a standard for minimizing
dripping. In addition, EPA
[[Page 56933]]
is considering incorporating a provision to provide exceptions for
pesticides not classified as DOT hazardous materials that would be
similar to the limited quantity exceptions in the DOT HMR.
Potential regulatory language that is being considered for the
approach of referring to and adopting the DOT standards is provided in
Unit VII of this document.
C. Discussion
1. Adoption of the DOT standards. The HMR are based on the
authority in the Federal hazardous materials transportation law, the
Hazardous Materials Transportation Act, and are found in 49 CFR Parts
171 through 180. The HMR establish standards governing a wide range of
the safety aspects of transportation, including requirements for
classification of materials, packaging (including manufacture,
continuing qualification, and maintenance), hazard communication (i.e.,
package marking, labeling, placarding, and shipping documentation),
transportation and handling, and incident reporting. For the purposes
of applying DOT standards to pesticides that are not classified as DOT
hazardous materials, EPA has focused on the DOT requirements for
package design (and manufacture, continuing qualification, and
maintenance) and package marking, because these are the areas that
overlap with the proposed pesticide container standards. EPA is not
considering incorporating the HMR standards for labeling, placarding,
shipping documentation, transportation and handling, and incident
reporting for pesticides that are not classified as DOT hazardous
materials. In general, these standards are outside the scope of the
original proposed rule for pesticide containers and containment. In
other words, EPA is considering referring to and adopting only a subset
of the DOT HMR for pesticides that are not classified as DOT hazardous
materials.
The DOT HMR include general packaging requirements that address
areas such as compatibility, closures, venting, and filling limits. The
HMR also set out performance standards for packaging, including drop,
leakproofness, hydrostatic pressure, stacking, and vibration tests. The
stringency of these tests varies according to the packing group (PG) of
the material being transported. The packing group represents a measure
of the relative hazards, where PG I includes materials that pose a
relatively great hazard and PG III includes materials that pose a
relatively minor hazard.
Under the revisions to the pesticide container rule being
considered, pesticides that are classified as DOT hazardous materials
would continue to be packaged in accordance with the DOT HMR. Most
pesticides that are classified as DOT hazardous materials are in
Packing Group III, although some are in PG II and a few are in Packing
Group I. (Ref. 8) Nothing in the pesticide container rule would change
any of the incorporated DOT requirements -- if a pesticide is
categorized as a PG II material, it would continue to have to meet the
PG II standards and likewise for pesticides in PG I or PG III.
Under the regulatory approach being considered, pesticides that are
not classified as DOT hazardous materials would be required to be
packaged in accordance with the specified packaging design,
construction, and marking standards that would apply to a DOT PG III
material. Such pesticides would not have to meet the DOT standards for
labeling, placarding, or shipping papers which, as discussed above, are
outside the scope of the original proposed container regulations.
Specifically, pesticides that are not classified as DOT hazardous
materials would have to comply with the packaging standards in 49 CFR
173.24, 173.24a, 173.24b, 173.28, 173.203, 173.213, 173.240, and
173.241, the packaging standards and testing requirements in 49 CFR
part 178; and the continuing qualification and maintenance requirements
in 49 CFR part 180. EPA would retain its independent authority to
enforce compliance with these regulations as with any other regulations
promulgated under FIFRA.
2. Include pesticide-specific standards. One issue involved with
the regulatory approach under consideration is whether the DOT package
design and marking standards should be the only requirements for
pesticide containers or whether EPA should promulgate additional
standards that apply only to pesticide containers. Some of the
commenters on the proposed rule implied that the only standards
necessary are the DOT standards and that EPA should not add any
additional requirements. EPA disagrees with this assessment and
believes that it is appropriate to promulgate additional pesticide-
specific requirements because the purposes of the two sets of
regulations are different.
The Hazardous Materials Transportation Act provides DOT with the
authority to ``issue regulations for the safe transportation of
hazardous materials in intrastate, interstate, and foreign commerce ...
[that] shall govern any aspect of hazardous materials transportation
safety which the Secretary of Transportation deems necessary or
appropriate.'' An overall goal of this law is ``to improve the
regulatory and enforcement authority of the Secretary of transportation
to protect the Nation adequately against the risks to life and property
which are inherent in the transportation of hazardous materials in
commerce.''
Section 19 of FIFRA gives EPA a much broader mandate for addressing
pesticide containers. Section 19(e) requires EPA to promulgate
``regulations for the design of pesticide containers that will promote
the safe storage and disposal of pesticides.'' This section further
specifies that the regulations ensure that containers accommodate
procedures used for the removal of pesticides and facilitate the safe
use, safe disposal, safe refill, and safe reuse of the containers. In
addition, section 19(f) requires EPA to ``promulgate regulations
prescribing procedures and standards for the removal of pesticides from
containers prior to disposal.''
EPA believes the broader mandate in FIFRA justifies the approach of
requiring that pesticides meet certain pesticide-specific requirements
in addition to the DOT standards. In the regulatory option under
consideration, EPA would not include in the final regulations a
proposed FIFRA-specific container standard if there was an equivalent
DOT standard (e.g., the drop test for minibulks). EPA would merely
incorporate the equivalent DOT standard. However, EPA would retain
other proposed standards (e.g., the container dispensing standards to
minimize dripping and to require pouring in a continuous, coherent
stream) that did not have equivalent DOT standards.
Therefore, all pesticides that would be subject to the pesticide
container regulations -- regardless of whether or not they are
classified as DOT hazardous materials -- would have to comply with both
the DOT HMR requirements incorporated into EPA's regulations and the
pesticide-specific requirements in the final pesticide container rule.
Table 6 categorizes the proposed pesticide container ``design'' and
marking requirements according to whether or not the DOT HMR have an
equivalent standard. The table is included only to provide a general
idea of the proposed requirements that EPA may replace in the final
rule with DOT standards and those proposed standards that EPA would
retain as pesticide-specific requirements. EPA is not soliciting
further comments on the
[[Page 56934]]
proposed pesticide container standards listed in the table, except
regarding the extent to which DOT standards are appropriate equivalents
to such standards. EPA has considered the comments previously submitted
on these proposed requirements and will continue to do so as the final
rule is developed.
Table 6.-- Comparison of the Proposed Container Standards with the DOT
Requirements
------------------------------------------------------------------------
Proposed Pesticide Container Proposed 40 CFR Equivalent 49 CFR
Requirement Cite Cite
------------------------------------------------------------------------
Proposed Pesticide Container
Standards with DOT Equivalents
Nonrefillables: Container 165.102(b) 173.24(b)
integrity/compatibility........ 173.24(e)
Nonrefillables: Marking - 165.102(c)(2) 178.3(a)
container material............. 178.503(a)
Nonrefillables: Dispensing - 165.102(d)(3) 173.24(f)
reclose securely...............
Nonrefillables: Certification\1\ 165.111 178.2(a)(2)
Nonrefillables: Recordkeeping\1\ 165.114 178.601(l)
Refillables: Marking other than 165.124(b) 178.3(a)
serial number and EPA statement 178.503(a)
178.703
Refillables: Minibulk container 165.124(c) 173.24(b)
integrity...................... 173.24(e)
178.704
Refillables: Drop test for 165.124(d) 178.603
minibulk containers............ 178.803
178.810
Refillables: Drop test 165.125 178.602
methodology.................... 178.603
Refillables: Certification\1\... 165.126 178.2(a)(2)
Refillables: Recordkeeping\1\... 165.128 178.601(l)
178.801(l)
Refillables: Inspection prior to 165.134(e) 173.28
refill......................... 180.352
Refillables: Age of plastic 165.134(f) no time limit
liquid minibulk................
Proposed Pesticide Container
Standards without DOT Equivalents
Nonrefillables: Marking - EPA 165.102(c)(1) none
registration no................
Nonrefillables: Dispensing - 165.102(d)(1) none
minimize glugging..............
Nonrefillables: Dispensing - no 165.102(d)(2) none
dripping.......................
Nonrefillables: Standardized 165.102(e) none
closures.......................
Nonrefillables: Residue removal 165.104 none
standard.......................
Refillables: Marking - serial 165.124(b) none
number and EPA statement.......
Refillables: Apertures.......... 165.125(e) none
Refillables: Bulk container 165.124(f) none
standards......................
------------------------------------------------------------------------
\1\ The DOT HMR include provisions for certification and recordkeeping
for the standards in the HMR. However, EPA may choose to retain the
proposed certification and recordkeeping requirements for the
pesticide-specific requirements.
The proposed ``procedural'' requirements for registrants and
refillers in proposed 40 CFR 165.130, 165.132, 165.134, and 165.136 are
not included in the table because they are not container design or
marking requirements. These four sections would establish requirements
for registrants to develop and provide certain documents to refillers,
for refillers to obtain these documents and follow specified container
handling procedures, and for both registrants and refillers to maintain
records. Under the approach being considered for the final rule, EPA
would generally retain these procedural standards in the final rule.
However, some of the requirements, such as the registrants providing
refillers a list of acceptable containers which would be identified by
the container manufacturer and model number, may need to be modified to
mesh with the revisions.
3. Limited quantity exception. The HMR include exceptions from
portions of the overall regulatory scheme in certain situations, e.g.,
for damaged packages placed in salvage drums (49 CFR 173.3), for small
quantities of hazardous materials (49 CFR 173.4), and for the shipment
of waste materials (49 CFR 173.12). Also, the regulations in 49 CFR
173.150 - 173.156 set out limited quantity and consumer commodity
exceptions for different hazard classes and divisions. The limited
quantity exceptions provide relief from some of the HMR requirements,
specifically the labeling requirements (unless the package is
transported by aircraft), the packaging standards and testing
requirements in 49 CFR part 178, and the placarding provisions. Also,
if a limited quantity meets the definition of ``consumer commodity,''
relief from the shipping paper requirements is provided in many cases.
In the HMR, the size of packages that are eligible for limited
quantity exceptions varies according to the
[[Page 56935]]
hazard class (e.g., Class 8), hazard division (e.g., Division 6.1),
and, in some cases, the packing group of the material. The DOT limited
quantity exceptions generally provide regulatory relief from the HMR,
although they do add some requirements. First, the exceptions only
apply to combination packaging (e.g., four plastic jugs in a cardboard
box). Second, the packaging must comply with the general packaging
standards in 49 CFR 173.24. Third, the package cannot exceed 30
kilograms (66 pounds) gross weight.
Pesticides already regulated under DOT's hazardous materials
regulations as Packing Group I, II or III materials shall be subject,
under EPA's FIFRA regulations, to the same limited quantity exception
to which they are subject under DOT's regulations. For pesticides not
already regulated under DOT's regulations, EPA is considering
incorporating the relevant parts of the limited quantity exception in
49 CFR 173.155 for Class 9 hazardous materials (miscellaneous hazardous
materials) into the final pesticide container rule. Based on amendments
made by DOT in 1996, the package sizes eligible for the Class 9 limited
quantity exceptions are those that are less than 5.0 liters (1.3
gallons) for liquids and less than 5.0 kilograms (11 pounds) for
solids. The purposes of incorporating a DOT limited quantity exception
are to maintain consistency with the HMR and to provide regulatory
relief for relatively small quantities of pesticides.
EPA is considering using the Class 9 limited quantity exception
for pesticides not previously covered by DOT regulations for several
reasons. First, Class 9 includes miscellaneous hazardous materials,
which are defined in 49 CFR 173.140 to be materials that pose a hazard
during transportation but don't meet the definition of any other hazard
class. Pesticides that have not previously been covered by DOT's
hazardous materials regulations (i.e., that are not classified as DOT
hazardous materials) logically fit into such a grouping. Second, DOT
has generally placed hazardous materials that are defined as DOT
hazardous materials as a result of EPA regulation (e.g. hazardous
substances under the Comprehensive Environmental Response,
Compensation, and Liability Act and hazardous wastes under RCRA) into
Class 9. Therefore, EPA would be following DOT precedent by regulating
these pesticides consistently with many other Class 9 hazardous
materials.
Under the regulatory approach being considered, EPA would be
applying only the DOT packaging and marking standards to pesticide
containers -- not the DOT labeling, placarding, and shipping paper
requirements. Therefore, only the ``relevant parts'' of the limited
quantity exception would need to be incorporated -- not the provisions
that relate to DOT labeling, placarding, and shipping paper standards.
Also, EPA believes it is unnecessary to incorporate the consumer
commodity exception (as opposed to the limited quantity exception)
because the only additional relief provided by a consumer commodity
exception is from the shipping paper requirements.
4. EPA modification. The regulatory text under consideration (in
Unit VII of this document) includes a provision that would allow EPA to
modify or waive the requirements of the regulatory section that refers
to and adopts the DOT requirements if a person provides an application
for exemption to the Director of the Office Pesticide Programs that
contains data showing that the alternative, i.e., the partial or
modified, set of standards achieves a level of safety that is at least
equal to that specified in the requirements of this section. This
provision is included to provide flexibility in cases where, for some
reason, a container could not meet all of the DOT packing group III
standards, but would still function safely and adequately during the
use, handling, cleaning, and disposal of the pesticide container.
The DOT standards provide the regulated industry with a similar
opportunity to obtain administrative relief from the Hazardous
Materials Regulations through an exemption process described in 49 CFR
part 107. DOT receives applications for exemptions and grants
exceptions if the situations meet the criterion of equivalent levels of
safety or levels of safety consistent with the public interest and the
policy of the Hazardous Materials Transportation Act. For example, in a
Federal Register notice (Ref. 9), DOT announced the actions taken on
exemptions from July 1997 through December 1997, which included
granting 32 modification exemptions, 48 new exemptions and 39 emergency
exemptions, denying seven exemption applications, and having seven
exemption applications withdrawn.
It is essential for EPA to incorporate a modification process into
its regulations to prevent EPA regulations from being less flexible
than the DOT requirements, which would happen if DOT granted an
exemption for a pesticide and EPA did not have a mechanism to provide
the same relief. EPA anticipates that the modification process would be
used predominantly to maintain consistency with exemptions granted by
DOT that affect pesticides, although EPA would maintain its authority
to deny an exemption, even where DOT has granted an exemption, if EPA
could not find that an exemption was appropriate under FIFRA and its
regulations. On the other hand, EPA could choose to implement the
modification provision for technical reasons, if a registrant can show
that the modified or more limited set of standards achieves a level of
safety that is at least equal to the full set of incorporated DOT
requirements.
EPA believes the draft modification provision is sufficient because
of the interaction between the Agency and pesticide registrants,
despite the fact it is significantly less detailed than the DOT
exemption process. However, EPA is considering the option of adopting a
more detailed exclusion process in the final rule if the Agency
concludes that a general provision would not be adequate, based on
comments or information received during the comment period.
5. Providing notice to the public. The regulatory text under
consideration (in Unit VII of this document) also includes a provision
that says EPA will provide notice to the public in the Federal Register
if DOT proposes to change any of the regulations that are incorporated
in EPA's pesticide container regulations. The intent of this provision
is to ensure that the pesticide-related regulated community is notified
of regulatory modifications being considered by DOT, since the
pesticide industry may not regularly monitor DOT's regulatory activity.
6. Alternative approach. Under the regulatory approach being
considered for the final rule, EPA would refer to and adopt the full
HMR for pesticides that are classified as DOT hazardous materials.
Specifically, Sec. 165.102(b)(1) of the potential alternative
regulatory language includes the following statement: ``Pesticide
products that meet the definition of a hazardous material in 49 CFR
171.8 shall be packaged as required by 49 CFR parts 171-180.'' EPA
believes this approach is advantageous because EPA could enforce the
DOT standards for pesticides that are DOT hazardous materials.
However, EPA is considering not explicitly stating in its
regulations that pesticides that are DOT hazardous materials must
comply with the DOT HMR. EPA requests comments on whether the Agency
should simply include a reference to the DOT HMR, such as ``Pesticide
products that meet the definition of a hazardous material in 49 CFR
171.8 are subject to the
[[Page 56936]]
requirements of 49 CFR parts 171-180.'' Another alternative would be to
cite only the portions of the HMR that pesticides that are not
classified as DOT hazardous materials would have to comply with.
Under the regulatory approach being considered for the final rule,
pesticides that are not classified as DOT hazardous materials would be
required to be packaged in accordance with the specified packaging
design, construction, and marking standards that would apply to a DOT
packing group III material. EPA believes this approach would be the
most straightforward in terms of compliance by the regulated industry
and enforcement by the appropriate governmental agencies. The pesticide
registrants and enforcement officials could rely on the marking
indicating compliance with the packing group III standards.
EPA considered but rejected an alternative approach specifying that
pesticides that are not classified as DOT hazardous materials would be
required to be packaged in containers that are capable of meeting the
specified packaging design, construction, and some of the marking
standards that would apply to a DOT packing group III material. Under
this approach, the containers would not actually have to be marked to
indicate compliance with the PG III standards. This would eliminate the
need to comply with some of the continued maintenance and production
testing. However, to make this approach work logistically, EPA would
have to specify some recordkeeping so the Agency could determine that
the containers were capable of meeting the PG III standards and require
some marking, such as ``Meets EPA standards for refillable containers''
to provide an indicator of compliance to enforcement officials.
Standards similar to these two provisions were included in the proposal
and were strongly criticized by commenters, who opposed standards that
would create a different framework and set of packaging standards for
accomplishing the same goals as the existing DOT standards.
D. Request for Comments
EPA requests comments on the regulatory approach discussed above
for revising the pesticide container regulations to refer to and adopt
the DOT HMR packaging and marking standards. In addition to general
comments, EPA solicits comments on the following questions and issues:
(1) Is it clear which portions of the DOT HMR would be referred to
and adopted?
(2) Does the sample regulatory text in Unit VII of this document
accomplish EPA's intent?
(3) Is the approach of incorporating the Class 9 limited quantity
exception appropriate?
(4) The regulatory option under consideration would expand the
number of tests containers are required to meet. Under the original
1994 proposal, nonrefillable containers weren't subject to any of the
DOT performance tests and minibulks were subject to a drop test only.
Despite the large increase in potentially applicable testing
requirements, EPA believes referring to and adopting the DOT HMR PG III
standards would not greatly increase the economic burden of the
regulations because: (i) Many pesticide products, including an
estimated one-third of all agricultural products, are classified as DOT
hazardous materials (Ref. 8); (ii) many other pesticides are packaged
in containers that meet the DOT PG III standards, even though it isn't
required; and (iii) the container and pesticide manufacturing
industries are familiar with the DOT regulations. Is EPA's assessment
that there would only be a relatively minor cost increase attributed to
the regulatory approach being considered accurate? EPA also requests
specific information about the potential economic impacts of referring
to and adopting the DOT PG III standards, such as the costs of
conducting the leakproofness, hydrostatic pressure, stacking, and drop
testing.
(5) In general, the proposed regulations would apply to all types
of packaging, including but not limited to rigid (plastic and steel)
containers, paper and plastic bags, and water-soluble packaging,
although specific requirements would apply to appropriate subsets of
these container types. Under the regulatory approach discussed in this
document, EPA would require all types of pesticide containers to meet
the DOT PG III standards. EPA believes that it may be easier for some
kinds of packaging, e.g., rigid plastic or steel containers, to comply
with the DOT PG III standards than for other types of containers, e.g.,
bags or water-soluble film. EPA requests comments about whether the
ease of complying with the DOT PG III standards varies according to the
container type and whether certain kinds of packaging may be
disproportionately impacted.
(6) Is the provision that would allow EPA to modify or waive the
requirements referring to and adopting the DOT requirements sufficient
or should EPA include a more detailed exemption provision?
(7) Should EPA adopt any of the alternative approaches discussed in
Unit V.C.6 of this document instead of the preferred approach discussed
in Units V.B and V.C.1 - V.C.5 of this document?
VI. Proposed Definition of Small Business Used in Impact Analysis
As discussed in Unit II.A. of this document, section 601(3) of the
RFA establishes as the default definition of small business the SBA
size standards, which are primarily intended to define whether a
business entity is eligible for government programs and preferences
reserved for small businesses (13 CFR 121.101). Section 601(3) of the
RFA also allows an agency to establish an alternate definition of small
business after consultation with the SBA Office of Advocacy and after
notice and an opportunity for public comment.
In the regulatory impact analyses (RIA) and the initial regulatory
flexibility analyses for the 1994 proposed rule (Ref. 10 and 11), EPA
used alternate definitions of small business for identifying the
potentially affected small entities. The alternate definitions were
presented in these analyses, but EPA did not specifically solicit
comment on these alternate definitions in conjunction with the 1994
proposed rule. EPA is, therefore, specifically seeking comment on the
establishment of these alternate definitions for use in identifying
small pesticide formulators, small agrichemical dealers, and small
independent custom (aerial and ground) applicators for analytical
purposes related to this rulemaking. These alternate definitions are
only used for analytical purposes and do not in any way affect the
scope or any other provision of the proposed rule.
The following discussion provides additional information about the
alternate definitions that EPA used in the regulatory flexibility
analysis for the 1994 proposed rule.
A. Overview of the Alternate Definitions for Use in the Analysis
As described in Unit I.A. of this document, the three major
industry sectors that would be affected by the pesticide container and
containment rule are pesticide formulators, agrichemical dealers, and
independent custom (aerial and ground) applicators. The SBA, at 13 CFR
part 121, defines a small business as having:
500 or fewer employees for pesticide formulators (SIC
2879)
100 or fewer employees for agrichemical dealers (SIC 5191)
[[Page 56937]]
Maximum revenues of $5.0 million for independent
applicators (SIC 0721)
In analyzing the potential impacts of the 1994 proposed rule, EPA
determined that it was appropriate to use alternate definitions to
assess the potential impacts on small pesticide formulators, small
agrichemical dealers, and small independent custom (aerial and ground)
applicators. EPA's alternative definitions of small businesses for
pesticide formulators, agrichemical dealers, and independent commercial
pesticide applicators are given in the following table 7. SBA's
definitions are also provided in the table for the purposes of
comparison.
Table 7.--Comparison of the Definitions of Small Businesses to Use in
Analyzing Impacts
------------------------------------------------------------------------
Definition of Small Business
---------------------------------------
Industry Sector SBA definition (13 Proposed EPA
CFR part 121) definition
------------------------------------------------------------------------
Pesticide formulators........... 500 or fewer 1 to 19 employees
employees.
Agrichemical dealers............ 100 or fewer 1 to 9 employees
employees.
Independent commercial Maximum revenues One plane and
applicators\1\. of $5.0 million. $93,750 in sales
------------------------------------------------------------------------
\1\ Profiles of small, medium, and large facilities were developed for
aerial applicators but not for ground applicators, because not enough
information was available to profile ground applicators.
B. Discussion
After careful consideration of the SBA small business definitions
for the three industry sectors, EPA determined that it was appropriate
to use alternate definitions of small business. As indicated
previously, the SBA size standards are primarily intended to define
whether a business entity is eligible for government programs and
preferences reserved for small businesses (13 CFR 121.101), with the
objective ``to ensure that a concern that meets a specific size
standard is not dominant in its field of operation.'' (13 CFR
121.102(b)). See section 632(a)(1) of the Small Business Act. Under
SBA's definitions, all agrichemical dealers, all independent commercial
applicators, and nearly all pesticide formulators would be considered
small businesses. When assessing the potential impacts on small
entities, however, EPA believes that it is important to ensure that the
definition of small business is not as broad. EPA is concerned that
using an overly broad definition of small business in the analysis may
cause potentially significant economic impacts on smaller facilities to
be camouflaged when combined with information about potential impacts
on those facilities that meet the SBA size standard for small business,
but which are not typical of a small business in that industrial
sector. For example, a small pesticide formulator with 1 to 19
employees is going to have significantly different sales and profits
than a formulating facility with over 100 employees. To account for
such differences, facilities in the pesticide formulating, agrichemical
dealer, and independent applicator industries were profiled as small,
medium or large, as summarized in the following table 8.
Table 8.-- Profile of Small, Medium, and Large Business Categories Used
in the Impact Analysis
------------------------------------------------------------------------
Definition of Number of Percent of
Industry sector/size category facilities facilities
------------------------------------------------------------------------
Pesticide formulators
Small....................... 1 to 19 172 62
employees.
Medium...................... 20 to 99 81 29
employees.
Large........................ 100 to 2,499 24 9
employees.
Agrichemical dealers
Small....................... 1 to 9 12,991 77
employees.
Medium...................... 10 to 49 3,623 22
employees.
Large........................ 50 to 99 181 1
employees.
Independent applicators\1\
Small........................ 1 plane and 780 39
$93,750 in
sales.
Medium....................... 2 to 4 planes 1,120 56
and $375,000
in sales.
Large........................ 5 or more 100 5
planes and
$750,000 in
sales.
------------------------------------------------------------------------
\1\ Profiles of small, medium, and large facilities were developed for
aerial applicators but not for ground applicators, because not enough
information was available to profile ground applicators.
In considering the analysis of the 1994 proposed rule on pesticide
formulators, the RIA defined a number of ``representative'' facilities,
with different financial characteristics (e.g., sales, net profit
before tax, and tax rate) and varying operating characteristics (number
of employees, filling lines, and formulations). The RIA then evaluated
the impacts of three different regulatory options on a small and
medium-sized representative facility in each of the four different
pesticide markets (agricultural, industrial, institutional, and
household) and on four different kinds of large representative
facilities in the agricultural market. For each regulatory option, the
RIA also considered two different implementation scenarios for the
nonrefilable residue removal standard. Based on the regulatory
flexibility analysis prepared for the 1994 proposed rule, Table 9
provides a summary illustration of the representative facilities that
might be significantly impacted under the different regulatory options
and implementation scenarios presented in the 1994 proposed rule.
Table 9 below shows that, for the options/scenarios identified in
the analysis with a potential for significant impacts, the small
representative facilities are more likely to have these
[[Page 56938]]
impacts than the medium or large facilities. If EPA had evaluated the
impact of the proposed regulations on only medium or large facilities
(based on an ``average'' small business under SBA's definition), the
potential impacts on these small companies might not have been
identified as clearly in the analysis.
The initial regulatory flexibility analysis identified residue
removal testing as the most critical variable affecting EPA's small
formulators. The proposed regulations addressed this issue in several
ways. First, the proposal made allowances for using residue removal
test data from similar products and containers as documentation that
another container/formulation combination meets the residue removal
standard (i.e., implementation scenario 1). Second, the regulations
include a provision for obtaining a waiver from the residue removal
standard. The regulatory flexibility analysis also describes an
alternative to increase the compliance period for residue removal
testing, although this alternative was not included in the proposed
rule.
Table 9.--Representative Facilities that would be Significantly Impacted by the Proposed Pesticide Container Regulations\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\2\ Option 1 \2\ Option 2 \2\ Option 3
Representative Facility by Market and -----------------------------------------------------------------------------------------------------------------
Size \3\ Scenario 1 \3\ Scenario 2 \3\ Scenario 1 \3\ Scenario 2 \3\ Scenario 1 \3\ Scenario 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small agricultural facility........... x x x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small industrial facility............. x x x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small institutional facility.......... x x x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small household facility.............. x x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medium agricultural facility.......... x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medium industrial facility............ x x x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medium institutional facility......... x x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medium household facility.............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large agricultural facility 1.........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large agricultural facility 2.........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large agricultural facility 3......... x x
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large agricultural facility 4.........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ In the analysis, a representative facility was determined to be significantly impacted if the ratio of its annualized cost of compliance (ARR) over
its sales was greater than one percent and the ratio of its ARR over its profits before tax was greater than 20%.
\2\ EPA considered three regulatory options. Option 1 included the least stringent standards, option 2 was the EPA proposed rule, and option 3 included
the most stringent requirements.
\3\ For each regulatory option, EPA considered two implementation scenarios for the nonrefillable residue removal requirement. Under scenario 1, 50% of
container/formulation combinations would have to be tested to determine compliance with the residue removal standard. Under scenario 2, all container/
formulation combinations would have to be tested.
This example of the economic impact analysis and regulatory
flexibility analysis for pesticide formulators supports the use of
EPA's alternative definitions for small businesses, by showing that
EPA's alternative definitions:
Are more reflective of the small facilities in the
relevant industry sectors
Provide a more meaningful analysis of the facilities
likely to have the most significant economic impact
Distinguish facilities that have the stronger technical
expertise and larger revenue sources (and, therefore, can more easily
comply with the regulations) from those that do not.
C. Consultation with the SBA Office of Advocacy
EPA recently contacted the SBA Office of Advocacy for the purpose
of consulting on the use and establishment of the alternate definitions
of small business for analytical purposes related to this rulemaking.
(Ref. 12) After a discussion of the potential changes presented in this
action, the regulatory flexibility analysis prepared for the 1994
proposed rule, and the alternate definitions EPA used in that analysis,
the SBA suggested that EPA consider combining the small and medium
categories for the purpose of analyzing the potential impacts on small
entities. SBA indicated that it generally
[[Page 56939]]
recommends using a broader definition of small business to ensure a
broader assessment of the potential impacts on small entities.
Additional information is available in the public version of the
official record described in Unit I.B.3 of this document.
D. Request for Comments
EPA solicits comments on the alternate definitions used in the
impact analyses to identify small pesticide formulators, small
agrichemical dealers, and small independent commercial applicators. EPA
will consider SBA's recommendations, along with any public comments
received, when preparing the final rule. Comments regarding the
alternate definitions should be submitted to EPA according to the
process established in Unit I.C. of this document.
VII. Potential Alternative Regulatory Text
If the changes discussed in this document are adopted, the
potential alternative regulatory text in this section, or a variation
of it, may be incorporated into the final rule. However, EPA may choose
to retain the regulatory text from the original 1994 proposal or
incorporate language implementing one of the alternative approaches
discussed in this section.
EPA is considering the following two modifications to the
regulatory text for the final rule for Subpart F ``Nonrefillable
Container Standards: Container Design and Residue Removal.'' First, EPA
is considering replacing the proposed regulatory text for 40 CFR
165.100 with the following.
Sec. 165.100 Applicability and scope.
(a) Scope. 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
pesticide registrants.
(b) Manufacturing use products. This subpart does not apply to
containers that contain manufacturing use products, as defined in
Sec. 158.153(h) of this chapter.
(c) Antimicrobial pesticide products. (1) Except as provided in
paragraph (c)(2) of this section, this subpart does not apply to
containers that contain a pesticide product that meets all of the
following criteria:
(i) The pesticide product meets the definition of
``antimicrobial pesticide'' in FIFRA section 2(mm).
(ii) The label of the pesticide product includes directions for
use on sites in at least one of the following antimicrobial product
use categories:
(A) Food handling/storage establishments premises and equipment.
(B) Commercial, institutional, and industrial premises and
equipment.
(C) Residential and public access premises.
(D) Medical premises and equipment.
(E) Materials preservatives.
(F) Industrial processes and water systems.
(G) Antifouling coatings.
(H) Wood preservatives.
(I) Swimming pools.
(iii) The pesticide product does not meet the criteria for
hazardous waste as set out in part 261 of this chapter when the
pesticide product is intended to be disposed.
(2) A pesticide product that meets the criteria in paragraphs
(c)(1)(i) through (1)(iii) of this section is subject to the
following requirements if the pesticide meets the criteria of
Toxicity Category I as set out in Sec. 156.10(h)(1) of this chapter:
(i) 40 CFR 165.102(b) regarding DOT standards for nonrefillable
containers.
(ii) 40 CFR 165.102(c) regarding permanent marking for
nonrefillable containers.
(iii) 40 CFR 165.102(d) regarding container dispensing for
nonrefillable containers.
(iv) 40 CFR 165.111 regarding certification for nonrefillable
containers.
(v) 40 CFR 165.114 regarding recordkeeping and inspections for
nonrefillable containers.
(vi) 40 CFR 165.117 regarding compliance dates for nonrefillable
containers.
(d) General applicability. Except for pesticide products that
are excluded by paragraph (b) of this section or addressed by
paragraph (c) of this section, a pesticide product distributed or
sold in a nonrefillable container shall meet all of the standards of
this subpart if at least one of the conditions in paragraphs (d)(1)
through (4) of this section is met:
(1) The product meets the criteria of Toxicity Category I as set
out in Sec. 156.10(h)(1) of this chapter.
(2) The product meets the criteria of Toxicity Category II as
set out in Sec. 156.10(h)(1) of this chapter.
(3) The container size is equal to or larger than 5.0 liters
(1.3 gallons) for liquid formulations or 5.0 kilograms (11.0 pounds)
for solid formulations.
(4) The product label meets the standards in paragraphs
(d)(4)(i) and (ii) of this section.
(i) The product label includes at least one of the following
environmental hazard statements:
(A) This pesticide is toxic (or extremely toxic) to wildlife.
(B) This pesticide is toxic (or extremely toxic) to fish.
(C) This pesticide is toxic (or extremely toxic) to birds.
(D) This chemical is known to leach through soil into ground
water under certain conditions as a result of agricultural use. Use
of this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in ground-water
contamination.
(E) This chemical demonstrates the properties and
characteristics associated with chemicals detected in ground water.
Use of this chemical in areas where soils are permeable,
particularly where the water table is shallow, may result in ground-
water contamination.
(F) Any environmental hazard statement pertaining to wildlife,
fish, birds, or groundwater.
(ii) The product label permits outdoor use.
Second, EPA is considering deleting proposed Secs. 165.102(a)(3)
and 165.102(b) and incorporating the following regulatory text as
Sec. 165.102(b). Proposed Secs. 165.102(a)(1) and 165.102(a)(2) would
not be changed under the regulatory approaches being considered in this
document. The proposed standard for container integrity in proposed
Sec. 165.102(b) could be deleted because there is an equivalent
standard in the incorporated DOT standards.
Sec. 165.102(b) DOT standards. (1) Pesticide products that meet
the definition of a hazardous material in 49 CFR 171.8 shall be
packaged as required by 49 CFR parts 171-180. In addition, such
pesticide products shall comply with the requirements of this
subpart.
(2) Pesticide products that do not meet the definition of a
hazardous material in 49 CFR 171.8 shall be packaged in containers
that are designed, constructed, and marked to comply with the
requirements of 49 CFR 173.24, 173.24a, 173.24b, 173.28, 173.203,
173.213, 173.240, 173.241, Part 178, and Part 180 as applicable to a
Packing Group III material, liquid or solid, as appropriate. In
addition, such pesticide products shall comply with the requirements
of this subpart.
(3) Limited quantities of pesticide products that do not meet
the definition of a hazardous material in 49 CFR 171.8 are excepted
from the requirements set out in paragraph (b)(2) of this section
when packaged in combination packagings according to this paragraph.
Each package shall conform to the general requirements for
packagings and packages in 49 CFR 173.24 and may not exceed 30
kilograms (66 pounds) gross weight. The following combination
packagings are authorized:
(i) For liquids, inner packagings not over 5.0 liters (1.3
gallons) net capacity each, packed in strong outer packagings.
(ii) For solids, inner packagings not over 5.0 kilograms (11.0
pounds) net capacity each, packed in strong outer packagings.
(4) The Agency may modify or waive the requirements of this
section if a person provides an application for exemption to the
Director of the Office of Pesticide Programs that contains data
showing that the alternative (partial or modified) set of standards
achieves a level of safety that is at least equal to that specified
in the requirements of this section.
(5) If the Department of Transportation proposes to change any
of the regulations that are incorporated in paragraph (b)(1),
(b)(2), or (b)(3) of this section, the Agency will provide notice to
the public in the Federal Register.
EPA is considering the following two modifications to the
regulatory text for the final rule for Subpart G ``Refillable Container
Standards: Container Design and Residue Removal.'' First, EPA is
considering replacing the proposed regulatory text for 40 CFR 165.120
with the following potential alternative regulatory text. [This
language is very
[[Page 56940]]
similar to the above regulatory text for nonrefillable containers. The
main differences are the lists of regulatory sections that eligible
antimicrobial products in Toxicity Category I would have to comply
with.]
Sec. 165.120 Applicability and scope.
(a) Scope. This subpart establishes design and construction
standards and requirements for refillable containers used for the
sale or distribution of pesticide products. This subpart also
establishes the standards and requirements for repackaging pesticide
products into refillable containers.
(b) Manufacturing use products. This subpart does not apply to
containers that contain manufacturing use products, as defined in
Sec. 158.153(h) of this chapter.
(c) Antimicrobial pesticide products. (1) Except as provided in
paragraphs (c)(2) and (3) of this section, this subpart does not
apply to containers that contain a pesticide product that meets all
of the following criteria:
(i) The pesticide product meets the definition of
``antimicrobial pesticide'' in FIFRA section 2(mm).
(ii) The label of the pesticide product includes directions for
use on sites in at least one of the following antimicrobial product
use categories:
(A) Food handling/storage establishments premises and equipment.
(B) Commercial, institutional, and industrial premises and
equipment.
(C) Residential and public access premises.
(D) Medical premises and equipment.
(E) Materials preservatives.
(F) Industrial processes and water systems.
(G) Antifouling coatings.
(H) Wood preservatives.
(I) Swimming pools.
(iii) The pesticide product does not meet the criteria for
hazardous waste as set out in part 261 of this chapter when the
pesticide product is intended to be disposed.
(2) A pesticide product that meets the criteria in paragraphs
(c)(1)(i), (c)(1)(ii)(A) through (ii)(H), and (c)(1)(iii) of this
section is subject to the following requirements if the pesticide
meets the criteria of Toxicity Category I as set out in 40 CFR
156.10(h)(1):
(i) 40 CFR 165.124(a) regarding DOT standards for refillable
containers.
(ii) 40 CFR 165.124(b) regarding permanent marking for
refillable containers.
(iii) 40 CFR 165.124(e) regarding apertures for refillable
containers.
(iv) 40 CFR 165.124(f) regarding standards for bulk refillable
containers.
(v) 40 CFR 165.126 regarding certification for refillable
containers.
(vi) 40 CFR 165.128 regarding recordkeeping and inspection for
refillable containers.
(vii) 40 CFR 165.129 - 165.136 regarding procedural standards
for registrants and refillers who repackage pesticide into
refillable containers.
(viii) 40 CFR 165.139 regarding compliance date for refillable
containers.
(3) A pesticide product that meets the criteria in paragraphs
(c)(1)(i), (c)(1)(ii)(I), and (c)(1)(iii) of this section is subject
to the following standards if the pesticide meets the criteria of
Toxicity Category I as set out in Sec. 156.10(h)(1) of this chapter:
(i) 40 CFR 165.124(a) regarding DOT standards for refillable
containers;
(ii) 40 CFR 165.124(f) regarding standards for bulk refillable
containers;
(iii) 40 CFR 165.126 regarding certification for refillable
containers;
(iv) 40 CFR 165.128 regarding recordkeeping and inspection for
refillable containers;
(v) 40 CFR 165.129 regarding the transfer of registered
pesticide products into refillable containers;
(vi) 40 CFR 165.130 - 165.132 regarding procedural standards for
registrants who repackage pesticide into refillable containers;
(vii) 40 CFR 165.134(a) - 165.134(h) regarding procedural
standards for refillers who repackage pesticide into refillable
containers;
(viii) 40 CFR 165.136(a) regarding recordkeeping for each
pesticide product that is repackaged by a refiller; and
(ix) 40 CFR 165.139 regarding compliance date for refillable
containers.
(d) General applicability. Except for pesticide products that
are excluded by paragraph (b) of this section or addressed by
paragraph (c) of this section, a pesticide product distributed or
sold in a nonrefillable container shall meet all of the standards of
this subpart if at least one of the conditions in paragraphs (d)(1)
through (4) below is met:
(1) The product meets the criteria of Toxicity Category I as set
out in Sec. 156.10(h)(1) of this chapter.
(2) The product meets the criteria of Toxicity Category II as
set out in Sec. 156.10(h)(1) of this chapter.
(3) The container size is equal to or larger than 5.0 liters
(1.3 gallons) for liquid formulations or 5.0 kilograms (11.0 pounds)
for solid formulations.
(4) The product label meets the standards in paragraphs
(d)(4)(i) and (ii) of this section:
(i) The product label includes at least one of the following
environmental hazard statements:
(A) This pesticide is toxic (or extremely toxic) to wildlife.
(B) This pesticide is toxic (or extremely toxic) to fish.
(C) This pesticide is toxic (or extremely toxic) to birds.
(D) This chemical is known to leach through soil into ground
water under certain conditions as a result of agricultural use. Use
of this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in ground-water
contamination.
(E) This chemical demonstrates the properties and
characteristics associated with chemicals detected in ground water.
Use of this chemical in areas where soils are permeable,
particularly where the water table is shallow, may result in ground-
water contamination.
(F) Any environmental hazard statement pertaining to wildlife,
fish, birds, or groundwater.
(ii) The product label permits outdoor use.
Second, EPA is considering deleting proposed Secs. 165.124(a)(3)
and 165.124(c) and incorporating the following regulatory text as
Sec. 165.124(c). Proposed Secs. 165.124(a)(1) and 165.124(a)(2) would
not be changed under the regulatory approaches being considered in this
document. The proposed standard for minibulk container integrity in
proposed Sec. 165.124(c) could be deleted because there is an
equivalent standard in the incorporated DOT standards.
Sec. 165.124(c) DOT standards. (1) Pesticide products that meet
the definition of a hazardous material in 49 CFR 171.8 shall be
packaged as required by 49 CFR parts 171-180. In addition, such
pesticide products shall comply with the requirements of this
subpart.
(2) Pesticide products that do not meet the definition of a
hazardous material in 49 CFR 171.8 shall be packaged in containers
that are designed, constructed, and marked to comply with the
requirements of 49 CFR 173.24, 173.24a, 173.24b, 173.28, 173.203,
173.213, 173.240, 173.241, Part 178, and Part 180 as applicable to a
Packing Group III material, liquid or solid, as appropriate. In
addition, such pesticide products shall comply with the requirements
of this subpart.
(3) Limited quantities of pesticide products that do not meet
the definition of a hazardous material in 49 CFR 171.8 are excepted
from the requirements set out in paragraph (b)(2) of this section
when packaged in combination packagings according to this paragraph.
Each package shall conform to the general requirements for
packagings and packages in 49 CFR 173.24 and may not exceed 30
kilograms (66 pounds) gross weight. The following combination
packagings are authorized:
(i) For liquids, inner packagings not over 5.0 liters (1.3
gallons) net capacity each, packed in strong outer packagings.
(ii) For solids, inner packagings not over 5.0 kilograms (11.0
pounds) net capacity each, packed in strong outer packagings.
(4) The Agency may modify or waive the requirements of this
section if a person provides an application for exemption to the
Director of the Office of Pesticide Programs that contains data
showing that the alternative (partial or modified) set of standards
achieves a level of safety that is at least equal to that specified
in the requirements of this section.
(5) If the Department of Transportation proposes to change any
of the regulations that are incorporated in section (b)(1), (b)(2),
or (b)(3) of this section, the Agency will provide notice to the
public in the Federal Register.
VIII. Statutory Review Requirements
As required by FIFRA 25(a), this document was submitted to the U.S.
Department of Agriculture (USDA) for review and comment. USDA elected
not to comment officially on it. This document 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 document. The FIFRA Scientific
Advisory Panel
[[Page 56941]]
(SAP) waived its review of this document.
IX. References
1. U.S. EPA, ``Proposed Rule: Standards for Pesticide Containers
and Containment'' 59 FR 6712 (February 11, 1994).
2. U.S. EPA, ``Summary of Comments on the Proposed Rule on
Standards for Pesticide Containers and Containment,'' (October 28,
1996).
3. U.S. EPA, ``Appendix of Antimicrobial Product Use Sites and
Categories,'' (January 14, 1997).
4. Rogers, William H. ``Environmental Law: Hazardous Wastes and
Substances,'' West Publishing, St. Paul, Minnesota, pp. 40-59,
(1992).
5. U.S. EPA, ``Characterization of Antimicrobial Pesticides,''
(July 16, 1998).
6. U.S. EPA, ``Pesticide Industry Sales and Usage: 1994 and 1995
Market Estimates,'' number 733-R-002, (August 1997).
7. U.S. EPA, ``Pesticide Regulation (PR) Notice 96-8:
Toxicologically Significant Levels of Pesticide Active
Ingredients,'' (October 31, 1996).
8. U.S. EPA, ``Characterization of Pesticides as Department of
Transportation Hazardous Materials,'' (July 15, 1998).
9. U.S. DOT, ``Notice of Actions on Exemption Applications,'' 63
FR 14990 (March 27, 1998).
10. U.S. EPA, ``Regulatory Impact Analysis: Proposed Container
Design and Residue Removal Regulations Under the Federal
Insecticide, Fungicide, and Rodenticide Act as Amended, 1988,''
(1993).
11. U.S. EPA, ``Regulatory Impact Analysis: Standards for
Pesticide Containment Structures Under the Federal Insecticide,
Fungicide, and Rodenticide Act as Amended, 1988,'' (1993).
12. U.S. EPA, ``Use of an Alternate Definition for `Small
Business' in the Small Entity Economic Impact Analysis Conducted for
the 1994 Proposed Standards for Pesticide Container and Containment
[RIN 2070-AB95],'' (1999).
13. U.S. EPA, ``Economic Analysis for the Potential Changes
Discussed in the Supplemental Federal Register Notice,'' (July 28,
1998).
14. U.S. EPA, ``Supporting Statement for SF-83; Container Design
and Residue Removal Regulations (40 CFR part 165),'' prepared for
EPA by Mitchell Systems Corporation (1993).
X. Regulatory Assessment Requirements
The regulatory assessment requirements applicable to the original
proposed rule are discussed in the preamble for that proposal. (See 59
FR 6774, February 11, 1994) The following discussion is intended to
supplement that original discussion by describing the regulatory
assessment requirements applicable to this action.
A. Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), it has been determined that this
action is not a ``significant regulatory action'' subject to review by
the Office of Management and Budget (OMB). The Agency's estimated
impacts of the proposed rule are contained in a document entitled
``Regulatory Impact Analysis: Proposed Container Design and Residue
Removal Regulations under the Federal Insecticide, Fungicide, and
Rodenticide Act as Amended, 1988'' (Ref. 10) The Agency's estimates
with regard to the potential changes discussed in this document are
contained in a document entitled ``Economic Analysis for the Potential
Changes Discussed in the Supplemental Federal Register Notice'' (Ref.
13). Both of these documents are available as a part of the public
version of the official record for this rulemaking (see Unit I.B.3 of
this document). The impacts related to the potential changes discussed
in this document are briefly summarized here.
1. Summary of potential economic impacts. EPA estimates that the
potential changes presented in this document would decrease the overall
estimated cost of the rule by 13 to 27%.
As set out in the Regulatory Impact Analysis (RIA) of the 1994
proposed rule (Ref. 10), the annualized cost of the proposed rule was
estimated to be between $38.7 million and $49.9 million, which would be
split between the pesticide formulating industry (about $20 million to
$27.2 million), the pesticide refilling industry ($11.2 million),
independent (for-hire) pesticide applicators ($1.6 million) and
pesticide end users ($6 million to nearly $10 million).
The potential regulatory changes discussed in this document would
primarily affect the pesticide formulating industry. The proposed
regulations that would apply to the pesticide refilling industry (i.e.,
mainly the ``procedural'' container-related standards and the
containment regulations), independent pesticide applicators (the
containment standards), and pesticide end users (the label
requirements) would not be modified significantly by the changes
discussed in this document.
EPA estimates that the potential changes discussed in this document
would decrease the overall cost of the rule by 13 to 27%. The
regulatory options discussed in Units III and IV of this document would
lower the costs by decreasing the number of pesticide products and
containers that would be subject to the pesticide container standards
and by excluding certain antimicrobial products from the nonrefillable
residue removal standard. (See Ref. 13 for a more detailed discussion
of the economic analysis.)
2. Antimicrobial exemption. EPA estimates that about 25% of the
20,000 currently registered pesticide products are eligible
antimicrobial pesticides. As discussed in Unit IV.C.3 of this document,
an estimated 70% of eligible antimicrobial pesticides are classified in
Toxicity Category I and, therefore, would be subjected to the container
standards. Also, the nonrefillable residue removal standard accounts
for about 50% of the annualized cost for the pesticide formulating
industry, as estimated in the economic analysis of the proposed rule.
If EPA implemented the exemption for certain antimicrobial products
as discussed in this document, 30% of the eligible antimicrobial
products would be exempt from the rule and the remaining products would
not have to comply with the nonrefillable residue removal standard. In
this scenario, the cost to the pesticide formulating industry for
eligible antimicrobials to comply with the rule would be $1.8 million
to $2.4 million (compared to a range of $5.0 million to $6.8 million
for the same products to comply with the proposed rule).
3. Modifications to the scope. For the purpose of analyzing how
many products, other than eligible antimicrobials, would be included by
the scope modifications under consideration, EPA estimates that 50 to
90% of pesticides other than eligible antimicrobial pesticides would
meet one of the scope criteria, as shown in the following table 10.
Table 10.--Analysis of the Scope Criteria Under Consideration
------------------------------------------------------------------------
Percentage of
Criterion products included
in criterion (%)
------------------------------------------------------------------------
Toxicity Category I.................................. 10 - 25
Toxicity Category II................................. 15 - 20
Environmental Hazard Statement....................... 10 - 20
Container Size....................................... 15 - 25
==================
Total.............................................. 50 - 90
------------------------------------------------------------------------
According to this estimate, 10 to 50% of products other than
eligible antimicrobials would be categorized as ``lower-risk'' and
would be exempt from the container standards. If EPA implemented the
modifications to the scope as discussed in this document, the cost to
the formulating industry for products other than eligible
antimicrobials to comply with the rule would be $7.5 million to $18.4
million
[[Page 56942]]
(compared to a range of $15.0 million to $20.4 million for the proposed
rule).
4. Combined cost decrease. Therefore, the estimated annual cost to
the pesticide formulating industry of the container standards
(considering the antimicrobial exemption and the modifications to the
scope) would be $9.3 million to $20.8 million. The following table 11
compares the costs of the container standards estimated for the
proposed rule and the changes being considered in this document. EPA
estimates that the changes considered in this document would lead to a
$6.4 million to $10.6 million cost decrease compared to the proposed
rule -- a 13 to 27% decrease.
Table 11.--Comparison of Cost Estimates
----------------------------------------------------------------------------------------------------------------
Annualized Cost (millions of $)
-------------------------------------- Percent Decrease
Industry Segment 1994 Proposal (59 Changes in this (%)
FR 6712) Document
----------------------------------------------------------------------------------------------------------------
Pesticide formulating industry......................... 19.9 - 27.2 9.3 - 20.8 31 - 53
Pesticide refilling industry........................... 11.2 11.2 0
Independent (for-hire) pesticide applicators........... 1.6 1.6 0
Pesticide end users.................................... 6.0 - 9.9 6.0 - 9.9 0
========================================================
Total................................................ 38.7 - 49.9 28.1 - 43.5 13 -27
----------------------------------------------------------------------------------------------------------------
5. DOT packaging standards. The third major regulatory change
considered in this document would require all pesticide containers
(that are subject to the container regulations) to comply with at least
the DOT packing group III standards in addition to pesticide-specific
requirements which were previously proposed. Unlike the other two
issues that have already been discussed, the change to refer to and
adopt the DOT PG III standards would increase the costs to the
pesticide formulating industry.
However, EPA believes that the magnitude of the cost increase from
referring to and adopting the DOT PG III standards will be relatively
minor, particularly compared to the $6.4 million to $10.6 million
decrease from the other changes. As discussed in Unit V.D of this
document, despite the increase in potentially applicable testing
requirements, EPA believes referring to and adopting the DOT standards
would not greatly increase the economic burden of the regulations
because: (i) Many pesticide products are classified as DOT hazardous
materials; (ii) many other pesticides are voluntarily packaged in
containers that meet the DOT standards; and (iii) the container and
pesticide manufacturing industries are familiar with the DOT
regulations.
6. Request for comments. EPA is interested in comments on its
assessment of the potential impacts associated with the changes
presented in this document. EPA is particularly interested in any
information or data specific to the number of products and containers
that would be excluded by these potential changes, and any information
or data related to the costs or cost savings attributable to each of
these potential changes.
B. Paperwork Reduction Act
This action does not contain any new information collection
requirements that need additional approval or review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act, 44
U.S.C. 3501 et seq (PRA). In conjunction with the proposed rule that
was published in 1994, EPA prepared an Information Collection Request
(ICR) document for the paperwork burden imposed by the proposed
container and labeling standards (EPA ICR No. 1631.01) (Ref. 14).
Although EPA specifically sought comment on the ICR document in the
proposed rule, EPA is hereby seeking additional comment on the original
estimated burden presented in that ICR document, specifically with
regard to the anticipated decrease in the burden resulting from this
action. The ICR document is available in the public version of the
official record for the proposed rule (Ref. 14), and a copy may be
obtained in person from the PIRIB as described in Unit I.B.3. of this
document, by mail from Sandy Farmer, OP Regulatory Information
Division; U.S. Environmental Protection Agency (2137); 401 M St., SW.;
Washington, DC 20460, by calling (202) 260-2740, or electronically by
sending an e-mail message to farmer.sandy@epa.gov.'' An electronic
copy of the ICR document has also been posted with this Federal
Register notice on EPA's home page.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information subject to OMB approval under
the PRA unless it displays a currently valid OMB control number. The
OMB control numbers for EPA's regulations, after initial publication in
the Federal Register as part of the final rule, are maintained in a
list at 40 CFR part 9. The information requirements contained in EPA's
1994 proposal, as potentially amended by the changes discussed in this
document, are not effective until EPA issues a final rule and has
obtained OMB approval for the information collection requirements
contained in the final rule.
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
EPA anticipates that the changes being considered in this document
should decrease the estimated total annual reporting and recordkeeping
burden of 573,425 hours by about 13 to 27%. This decrease results
mainly from decreasing the number of products and containers subject to
the regulations. Not requiring eligible antimicrobial products to
comply with the nonrefillable residue removal standard should further
decrease the original burden estimates. In addition, referring to and
adopting the DOT standards as a minimum should streamline the reporting
and recordkeeping process by allowing companies to use the processes
and systems they currently have in place for complying with the DOT
HMR. Many companies cited this as a significant reason for supporting
the
[[Page 56943]]
DOT regulatory option. On the other hand, the potential additional step
of EPA providing a separate notice in the Federal Register whenever DOT
issued a Federal Register notice that proposes to change any of the
incorporated DOT standards may increase the burden on EPA and industry.
However, EPA believes that any such increase would be insignificant
compared to the decreases described above.
Please note that OMB has not approved the ICR associated with the
container and labeling provisions in the 1994 proposed rule. Instead,
OMB provided comments about the proposed residue removal standard and
the potential burden that the standard may have on registrants of
products with active ingredients that have low toxicities or that are
present at small concentrations. Specifically, OMB stated that ``EPA
should consider less burdensome testing requirements to meet the
objective that disposal of containers pose no unreasonable risk to
health or the environment.'' As stated in Unit IV.C.3 of this document,
EPA is considering changes to the residue removal standard in the
context of preparing a final rule, but is not specifically addressing
this issue in this document. However, EPA's preferred approach for
implementing the FQPA antimicrobial provision -- excluding eligible
antimicrobial products in Toxicity Category I from the nonrefillable
residue removal standard and exempting all other eligible antimicrobial
products from the entire rule -- would greatly decrease the potential
burden that would be imposed by the final rule and would address OMB's
comment.
EPA is specifically interested in your comments on EPA's need for
this information, the accuracy of the provided burden estimates, and
any suggested methods for minimizing respondent burden, including the
use of automated collection techniques. Send comments on the ICR to the
EPA at the address provided in Unit I.C of this document. In addition,
send a copy of your comments on the ICR to OMB at the following
address: Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th St., NW., Washington, DC 20503, marked
``Attention: Desk Officer for EPA.'' Please remember to include the ICR
number in any correspondence. The final rule will respond to comments
that EPA receives on the information collection requirements.
C. Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(Public Law 104-4), EPA has determined that this regulatory action is
not subject to the requirements of sections 202 and 205, because this
action does not contain a ``Federal mandate'' that would result in
expenditures of $100 million or more for State, local, or Tribal
governments, in the aggregate, or for the private sector in any one
year. This regulatory action would not impose an enforceable duty on
any State, local or Tribal governments or on anyone in the private
sector. In addition, this document contains no regulatory requirements
that might significantly or uniquely affect small governments.
Therefore, no action is needed under section 203 of the Unfunded
Mandates Reform Act.
D. Executive Order 12875
Under Executive Order 12875, entitled Enhancing Intergovernmental
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a
regulation that is not required by statute and that creates a mandate
upon a State, local or tribal government, unless the Federal government
provides the funds necessary to pay the direct compliance costs
incurred by those governments, or EPA consults with those governments.
If EPA complies by consulting, Executive Order 12875 requires EPA to
provide to the Office of Management and Budget a description of the
extent of EPA's prior consultation with representatives of affected
State, local and tribal governments, the nature of their concerns,
copies of any written communications from the governments, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 12875 requires EPA to develop an effective process
permitting elected officials and other representatives of State, local
and tribal governments ``to provide meaningful and timely input in the
development of regulatory proposals containing significant unfunded
mandates.''
Today's document does not create an unfunded Federal mandate on
State, local or tribal governments. This document does not impose any
enforceable duties on these entities. Accordingly, the requirements of
section 1(a) of Executive Order 12875 do not apply to this document.
E. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments, or EPA
consults with those governments. If EPA complies by consulting,
Executive Order 13084 requires EPA to provide to the Office of
Management and Budget, in a separately identified section of the
preamble to the rule, a description of the extent of EPA's prior
consultation with representatives of affected tribal governments, a
summary of the nature of their concerns, and a statement supporting the
need to issue the regulation. In addition, Executive Order 13084
requires EPA to develop an effective process permitting elected
officials and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.''
Today's document does not significantly or uniquely affect the
communities of Indian tribal governments. This document does not
involve or impose any requirements that affect Indian Tribes.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to this document.
F. Executive Order 12898
Pursuant to Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency has considered
environmental justice related issues with regard to the potential
impacts of this action on the environmental and health conditions in
low-income and minority communities and has determined that this
document will not adversely affect environmental justice.
G. Executive Order 13045
This document is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866 (see
Unit X.A above), nor do the environmental health or safety risks
addressed by this action have an affect on children.
H. Regulatory Flexibility Act
Pursuant to section 605(b) of the RFA, EPA hereby certifies that
this action will not have a significant economic impact on a
substantial number of small
[[Page 56944]]
entities. The RFA requires an agency to prepare a regulatory
flexibility analysis for any rule for which the agency is required to
issue a notice of proposed rulemaking under the Administrative
Procedures Act or any other statute, unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. This action does not impose any new
requirements that would result in any adverse impacts on the
potentially affected entities. Instead, the changes considered in this
document would decrease the potential impacts of the 1994 proposed
rule. EPA prepared an initial regulatory flexibility analysis for the
1994 proposed rule. Although EPA did not specifically certify under
section 605(b) of the RFA, EPA stated that the regulatory flexibility
analysis showed that there would not be significant impact on
potentially affected small facilities and that there would not be a
substantial number of small aerial applicators adversely impacted (see
59 FR 6712, at 6776). This action does not affect that conclusion and
the potential changes would only decrease the estimated total impact
presented in that analysis.
The initial regulatory flexibility analysis that EPA prepared as
part of the 1994 proposed rule made the following conclusions. First,
whether or not small formulating facilities would be significantly
impacted depended on how many container/formulation combinations would
need to be tested to confirm compliance with the proposed residue
removal standard. Second, representative refillers/refilling
establishments would not be adversely affected by compliance with the
1994 proposed regulations. Third, some small for-hire applicators,
primarily aerial application businesses, could be adversely affected by
the proposed containment requirements.
The potential changes discussed in this document would not affect
pesticide refillers and for-hire applicators significantly, so the
relevant conclusions presented in the initial regulatory flexibility
analysis that EPA prepared as part of the 1994 proposed rule would not
change. The rest of this discussion focuses on EPA's assessment of the
potential impact of the changes considered in this document on small
formulating facilities, including the nonrefillable residue removal
standard.
EPA anticipates that the changes being considered in this document
would decrease the costs for small formulators. As discussed
previously, EPA estimates that the changes in this document would lead
to a 13 to 27% lower cost than the cost of the proposed rule. EPA
believes that all formulators would experience similar cost decreases,
since formulators in each of the size categories -- small, medium, and
large -- would have products exempt from the container regulations by
either the antimicrobial exemption or the scope criteria.
In addition, EPA believes that the antimicrobial exemption would
make it unlikely that small formulating facilities in the household,
industrial, and institutional pesticide markets would be significantly
impacted. The crucial factor determining the significance of the impact
on these facilities was the implementation of the residue removal
standard. Under the approach being considered, antimicrobial products
that would be subject to the container standards (eligible
antimicrobial pesticides in Toxicity Category I) would not have to
comply with the nonrefillable residue removal standard. While small
household, institutional, and industrial formulators produce pesticides
other than antimicrobials, exempting antimicrobial products from the
nonrefillable residue removal standard should greatly decrease the
potential economic impact on these facilities. Also, it is worth noting
that changes to the residue removal standard are being considered
separately from this document.
As discussed previously, the change to refer to and adopt the DOT
PG III standards would increase the costs to the pesticide formulating
industry. However, EPA believes that the magnitude of the cost increase
from referring to and adopting the DOT PG III standards will be
relatively minor, particularly compared to the significant cost
decrease due to the other changes being considered. EPA therefore
certifies that the regulatory changes considered in this notice will
not have a significant economic impact on a substantial number of small
entities.
As discussed in Unit VI. of this document, EPA believes it is
appropriate to use alternate definitions of small business for the sole
purpose of assessing the potential impacts of the proposed rule on the
potentially impacted small businesses. With this document, EPA is
providing the public with an opportunity to comment on these
definitions and has consulted with the SBA Office of Advocacy as
required by section 601(3). Seeking comment on the use of the alternate
definitions does not impact EPA's ability to certify that this action,
which is likely to decrease the potential burden of the 1994 proposed
rule, will not result in a significant impact on a substantial number
of small entities. Comments regarding the potential impacts of these
changes, including any comments on the definitions, should be submitted
to EPA according to the process established in Unit I.C. of this
document.
I. National Technology Transfer and Advancement Act
This document does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Section 12(d) directs EPA to use voluntary consensus standards
in its regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, business practices, etc.) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA requires EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. EPA
invites public comment on this conclusion.
J. Federalism Review
On August 4, 1999, President Clinton issued a new executive order
on federalism, Executive Order 13132 (64 FR 43255, August 10, 1999),
which will go into effect on November 2, 1999. In the interim, the
current Executive Order 12612 (52 FR 41685, October 30, 1987) on
federalism still applies. Under this order, this rule will not have a
substantial direct effect upon States, upon the relationship between
the national government and the States, or upon the distribution of
power and responsibilities among the various levels of government. This
rule does not apply to States; it applies to pesticide registrants,
manufacturers and agricultural chemical dealers.
List of Subjects in 40 CFR Part 165
Environmental protection, Antimicrobial pesticides, Packaging and
containers, Pesticides and pests.
Dated: October 12, 1999.
Carol M. Browner,
Administrator.
[FR Doc. 99-27397 Filed 10-20-99; 8:45 am]
BILLING CODE 6560-50-F
