[Federal Register Volume 64, Number 106 (Thursday, June 3, 1999)]
[Proposed Rules]
[Pages 29823-29831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14070]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 176
[OPP-181051; FRL-5750-1]
RIN 2070-AD15
Tolerances for Pesticide Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing procedures and criteria under which EPA would
establish tolerances for residues of pesticide chemicals resulting from
emergency uses of pesticide chemicals authorized by EPA under section
18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This regulation is required by the Federal Food, Drug, and Cosmetic Act
(FFDCA), which was amended by the Food Quality Protection Act (FQPA) of
1996. FQPA established a new safety standard with special protections
for infants and children and extends this new protection to the
emergency use of pesticide chemicals. Specifically, FQPA requires EPA
to establish time-limited tolerances, or an exemption from the
requirement for a time-limited tolerance, for any pesticide uses
authorized by EPA under section 18 of FIFRA that may result in residues
in or on food (including animal feed). EPA actions under section 18 of
FIFRA are taken in response to a petition submitted by a Federal or
state agency. These proposed procedures and criteria will ensure that
the Agency is able to address more quickly any tolerance related issues
in conjunction with any decision made on the petition. EPA believes
that the procedures proposed in this document will be protective of
public health, while continuing to ensure availability of pesticides in
emergency situations.
DATES: Written comments, identified by the docket control number OPP-
181051, must be received on or before August 2, 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.C. of the SUPPLEMENTARY INFORMATION section of this
notice.
FOR FURTHER INFORMATION CONTACT:
Joseph E. Hogue, Policy and Regulatory Services Branch, Field and
External Affairs Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460,
telephone number: (703) 308-9072, e-mail address: hogue.joe@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Important Information
A. Does This Proposed Rule Apply to You?
You may be potentially affected by this proposed rule if you are
the Federal Government or a State or territorial government agency
charged with pesticide authority. Regulated categories and entities may
include, but is not limited to:
------------------------------------------------------------------------
Category Examples
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Federal Government................. Agencies that petition EPA for
section 18 pesticide use
authorization.
State and territorial government State that petition EPA for section
agencies charged with pesticide 18 pesticide use authorization.
authority.
------------------------------------------------------------------------
This table is not all inclusive, but is intended as a guide for
entities likely to be regulated by this action. To determine whether
this proposed rule applies to you, carefully read the applicability
criteria in a proposed Sec. 176.1. 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 or Copies of Support Documents?
1. Electronically. You may obtain electronic copies of this
document and various support documents are available from the EPA Home
page at the Federal Register--Environmental Documents entry for this
document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/).
2. In person. The official record for this proposed rule, as well
as the public version, has been established under docket control number
OPP-181051, (including comments and data submitted electronically as
described below). A public version of this record, including printed,
paper versions of any electronic comments, which does not include any
information claimed as CBI, is available for inspection in 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.
C. How and to Whom Do I Submit Comments to?
You may submit comments through the mail, in person, or
electronically:
1. By mail. Submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., S.W., Washington, DC 20460.
2. In person. Deliver written comments to: Public Information and
[[Page 29824]]
Records Integrity Branch, in Rm. 119, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA.
3. Electronically. Submit your comments and/or data electronically
to: opp-docket@epamail.epa.gov.'' Please note that you should not
submit any information electronically that you consider to be CBI.
Electronic comments must be submitted as an ASCII file avoiding the use
of special characters and any form of encryption. Comments and data
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number OPP-181051. Electronic comments on this
proposed rule may also be filed online at many Federal Depository
Libraries.
D. How Should I Handle Information That I Believe Is Confidential?
You may claim information that you submit in response to this
document as confidential 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 record. Information not marked confidential will be included
in the public docket by EPA without prior notice.
II. Authority
This action is issued under the authority of the Federal Food,
Drug, and Cosmetic Act as amended by the Food Quality Protection Act of
1996.
III. Background
The Food Quality Protection Act of 1996 (FQPA) was signed into law
August 3, 1996. FQPA amends both the Federal Food, Drug, and Cosmetic
Act (FFDCA), 21 U.S.C. 201 et seq., and the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among
other things, FQPA amends FFDCA to bring all pesticide tolerance-
setting activities conducted by EPA under a new section 408 with a new
safety standard and new procedures. FQPA also amends FFDCA by directing
EPA to establish time-limited tolerances for any pesticide use
authorized by EPA under section 18 of FIFRA that may result in residues
in or on food (including animal feed). The FQPA amendments went into
effect immediately.
EPA is proposing regulations to govern the establishment of time-
limited tolerances for pesticide uses authorized by EPA under section
18 of FIFRA. This proposed rule pertains only to regulatory changes
resulting from enactment of FQPA.
IV. Emergency Exemptions under Section 18
Section 18 of FIFRA authorizes EPA to exempt any Federal or state
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166. Generally, these regulations
allow a Federal or state agency to apply for an exemption to allow a
use of a pesticide that is not registered when such use is necessary to
alleviate an emergency condition. A state, as defined by FIFRA section
2(aa), means a state, the District of Columbia, the Commonwealth of
Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the
Pacific Islands and the American Samoa. The regulations set forth
information requirements, procedures, and standards for EPA's approval
or denial of such exemptions.
Federal and state agencies may petition EPA for a section 18
emergency exemption from FIFRA due to a public health emergency, a
quarantine emergency, or a ``specific'' emergency. Most exemptions from
FIFRA petitioned for or granted under section 18 fall under the
category of ``specific exemptions.'' Typical justifications for
specific exemptions include, but are not limited to, the introduction
of a new pest; the expansion of the range of a pest; the cancellation
or removal from the market of a previously registered and effective
pesticide product; and the development of resistance in pest to a
registered product, or loss of efficacy in available products for any
other reasons. Additionally, an emergency situation is generally
considered to exist when no other viable (chemical or non-chemical)
means of control exist, and where the emergency situation will cause
significant economic losses to affected individuals if the exemption is
not granted.
When a Federal or state agency petitions EPA under section 18, it
must submit a request in writing that documents the emergency
situation, the chemical(s) proposed for the use, the target pest, the
crop, the rate and number of applications to be made, the geographical
region where the chemical(s) would be applied, and a discussion of
risks which may be posed to human health or to the environment as a
result of the pesticide use (40 CFR 166.20). EPA conducts an expedited
review of the request, verifying the existence of the emergency,
assessing risks posed to human health through dietary exposure,
assessing risks posed to farmworkers and other handlers of the
pesticide, assessing any adverse effects on non-target organisms
(including federally listed endangered species), and assessing the
potential for contamination of ground and surface water. If an
application for the requested use has been made in previous years, EPA
does an assessment of the progress toward registration for the use of
the requested chemical on the requested crop, and considers this status
in the final determination to grant or deny the exemption. If EPA's
review concludes that the situation is an emergency, and that the use
of the pesticide under the exemption will not cause unreasonable
adverse effects on human health or the environment, then EPA may
authorize the pesticide to be used under section 18.
Section 18 pesticide uses for specific and public health exemptions
can be authorized for periods not to exceed 1 year; uses under
quarantine exemptions can be authorized for up to 3 years. Since
actions taken under section 18 are intended to address a time-specific
crisis or emergency need for temporary relief, most section 18
exemptions are specific exemptions which are granted for just one
growing season. Such actions should not, therefore, be reviewed as an
alternative to registering the use(s) needed for longer periods. If the
situation addressed with the section 18 exemption persists, or is
expected to persist, affected entities must take the proper steps to
amend the existing or seek a new registration to address that future
need.
In general, EPA attempts to form and communicate decisions on
section 18 requests within 50 calendar days of receipt of an exemption
application; in fiscal year 1998 (October 1, 1997--September 30, 1998),
EPA's average response time was 56 days. During FY98, EPA received
requests for 601 exemptions, of which 410 were approved (27 requests
were denied, 67 requests were withdrawn by states, and 97 requests were
still pending at the end of the fiscal year).
EPA maintains lines of communication with the State Departments of
Agriculture (or applicant) during the application review period so they
may keep growers informed on the status of the request. The Agency
works with the State Departments of Agriculture so that in case a
request might be denied, the affected growers may be able to find
alternative solutions. In the early stages of the development of this
proposed rule, EPA consulted with
[[Page 29825]]
representatives from the States of North Carolina and Washington on
behalf of the State's FIFRA Issues Research and Evaluation Group
(SFIREG). SFIREG identifies, analyzes and provides State comments to
the Office of Pesticide Programs on matters relating to pesticide
registration, enforcement, training and certification, water quality,
disposal and other areas of environmental concern related to pesticide
manufacture, use and disposal. In addition, SFIREG provides a mechanism
for EPA to keep the states informed and up-to-date on its pesticide
regulatory programs.
In September 1997, the Office of Pesticide programs formed a minor
use office which focuses on the special needs of growers of minor use
crops. EPA has expanded work in this respect with Interregional
Research Project No. 4 (IR-4), a U.S. Department of Agriculture (USDA)
program which provides national leadership and coordination for
information on the clearance of minor use pesticides and generates data
to support minor-use registrations. IR-4 will often help support minor
use emergency exemptions petitions.
The section 18 program can be an important part of developing
reasonable transition approaches for certain crops, especially minor
use crops, in moving to safer pest control methods. For example, in
certain situations, a pesticide needed for emergency use on minor use
crops might be registered for other use sites which have already filled
the ``risk cup.'' In order to address the needs of minor use farmers,
the Agency might work with pesticide registrants and growers to cap the
existing use on registered crops at a level that allows room in the
risk cup for use of the pesticide in combating an emergency. Under this
offset approach, the Agency could achieve either no risk increase or a
risk reduction and at the same time facilitate and permit critical
emergency exemptions.
In continuing efforts to implement FQPA, EPA is working together
with USDA to ensure that implementation of FQPA is informed by a sound
regulatory approach, by appropriate input from affected members of the
public, and by due regard for the needs of our Nation's agricultural
producers and other pesticide users.
V. Legal Basis of EPA Action
A. Residues in Food Prior to FQPA
Prior to enactment of FQPA, when EPA granted an emergency exemption
under section 18 for use of a pesticide that could result in residues
in or on food, EPA did not establish a tolerance or exemption from the
requirement for a tolerance under FFDCA. rather, EPA advised the Food
and Drug Administration (FDA) of the emergency exemption and the level
of residues that EPA concluded would be present in or on affected foods
as a result of the emergency use, and requested that FDA refrain from
enforcing against foods which contained residues of the pesticide due
to use under the exemption. Similarly, EPA informed the USDA of
pesticide use under an emergency exemption where residues would result
in meat, milk, or eggs.
B. FQPA Requirements
New section 408(l)(6) requires EPA to establish a tolerance or
exemption from the requirement for a tolerance for pesticide chemical
residues in or on food that will result from the use of a pesticide
under an emergency exemption granted by EPA under section 18 of FIFRA,
and requires that the tolerances be consistent with sections 408(b)(2)
and (c)(2) and FIFRA section 18. Section 408(l)(6) also requires EPA to
promulgate regulations governing the establishment of tolerances and
exemptions under section 408(l)(6). New FFDCA section 408(b)(2)(A)(i)
allows EPA to establish a tolerance (the maximum legal limit) for a
pesticide chemical residue in or on a food in accordance with the
following:
1. EPA must determine that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.''
Aggregate exposure includes exposure through food and drinking water,
as well as all non-occupational, non-dietary exposure, such as through
residential uses.
2. Section 408(b)(2)(C) requires EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue.* * *''
3. Section 408(b)(2)(D) specifies certain factors EPA is to
consider in establishing a tolerance. These factors include the use of
reliable data, nature of toxic effects, human risk involved, dietary
consumption patterns, cumulative effects of a pesticide residue with
other substances that have a common mechanism of toxicity, aggregate
exposure levels, variability of the sensitivities of subgroups of
consumers, endocrine disrupting effects, and appropriate safety
factors.
4. Section 408(b)(3) requires that there is a practical method for
detecting and measuring levels of the pesticide chemical residue in or
on food. A tolerance may only be established at a level at or above the
limit of detection of the designated method.
5. Section 408(c) governs EPA's establishment of exemptions from
the requirement for a tolerance using the same safety standard as
section 408(b)(2)(A) and incorporating the provisions of sections
408(b)(2)(C) and (D). In this preamble, EPA will use the terms
``tolerance'' to refer to exemptions from the requirement for a
tolerance as well.
Section 408(l)(6) requires EPA to establish tolerances in
connection with EPA's granting of FIFRA section 18 emergency
exemptions. When EPA establishes a tolerance under section 408(l)(6),
it may do so without providing notice or a period for public comment.
Tolerances established under section 408(l)(6) must also be consistent
with the safety standards in section 408(b)(2) and (c)(2) that are
applicable to all tolerances under section 408, and with FIFRA section
18. Section 408(l)(6) specifies that such tolerances shall have an
expiration date, but does not specify the duration of the tolerance.
VI. Interim Section 18 Practices
Since August 3, 1996, EPA has been acting on requests for section
18 exemptions and has been issuing associated tolerances on a case-by-
case basis under the new safety standard mandated by FQPA. The Agency
sent a letter to Federal and state agencies in September 1996,
informing them of the new procedures and issued guidance on interim
procedures in Pesticide Regulation Notice 97-1 (January 31, 1997). In
establishing section 18-related tolerances during this interim period
before issuing the section 408(l)(6) procedural regulation and before
making broad policy decisions concerning the interpretation and
implementation of the new section 408, EPA does not intend to set
precedents for the application of section 408 and the new safety
standard to other tolerances and exemptions. Rather, these early
section 18 tolerance decisions are being made on a case-by-case basis
and will not bind EPA as it proceeds with further rulemaking and policy
development.
[[Page 29826]]
VII. EPA Proposal
A. Scope
This proposal deals exclusively with procedures for setting time-
limited tolerances for pesticide chemical residues associated with
FIFRA section 18 emergency exemptions. The proposal does not modify any
regulatory policies or procedures associated with the issuance of an
emergency exemption itself, nor does it affect tolerance procedures
which fall under other sections of FIFRA or FFDCA.
B. Definitions
The terms defined in proposed Sec. 176.3 of the regulatory text
have the same meaning as FIFRA section 2, FFDCA section 201, and 40 CFR
part 166.
C. Request for a Section 18 Tolerance
Proposed Sec. 176.5 specifies that EPA will review data to
establish a time-limited tolerance for a pesticide to be used in an
emergency or crisis situation under section 18 only after it has
received the emergency exemption request or a crisis situation has been
declared.
D. Determining Reasonable Certainty of No Harm
In developing these proposed regulations, EPA considered several
approaches for assuring timely access to information adequate to ensure
that a section 18 tolerance, taking into account its limited duration
and emergency nature, meets the new FFDCA safety standard of reasonable
certainty of no harm.
For a number of reasons, EPA proposes to implement the new
provisions of FFDCA related to section 18 tolerances in Sec. 176.7 by
evaluating each submission on a case-by-case basis to determine if
adequate reliable data are available to make the ``reasonable certainty
of no harm'' finding mandated under section 408 of FFDCA. EPA believes
that timeliness of review in a manner responsive to the requirements of
the situation is of critical importance. EPA must be able to conclude
rapidly whether it has enough reliable data readily available to make a
safety finding under FFDCA for the requested use. Even if EPA concludes
that it is unable to establish a time-limited tolerance for the
requested use, the Agency will strive to make that conclusion in
sufficient time for the applicant to search for some additional method
to control the emergency pest situation. This case-by-case evaluation
is consistent with EPA's traditional approach to section 18 exemption
requests and with the statutory mandate of FFDCA section 408(l)(6).
In addition to the practical limits on the time available for
decision-making, EPA believes it is reasonable to rely on available
data for several other reasons, even though those data will generally
be less than those required for the establishment of a permanent
tolerance. Dietary exposures to pesticide chemical residues from use
under a section 18 exemption are generally less than those associated
with permanent tolerances because section 18 uses are of limited
duration, and because section 18 uses generally do not involve the
entire U.S. production of any crop since they are granted on a state-
by-state basis. Moreover, substantial hazard and exposure data are
usually available. Many section 18 exemption requests are for new use
sites of currently registered pesticides or for uses of previously
registered pesticides which are no longer in use. Consequently, EPA may
already have an extensive data base readily available to make the
reasonable certainty of no harm determination to set the tolerance.
Using available data is less likely to require significant increases in
the resources necessary to support exemption requests. It would not
significantly increase the regulatory burden on applicants by creating
new data requirements for section 18 exemptions nor significantly
increase costs to EPA for evaluating the requests. It is important to
limit the resource requirements of the section 18 program so that both
the Agency and applicants have sufficient resources to carry out their
other responsibilities under FIFRA and FFDCA.
1. Data requirements. Under this approach, EPA will review data
that has been submitted as required in 40 CFR part 158 for FIFRA
section 18 requests and whatever additional useful data it has
available in order to make the safety determination required under
FFDCA for establishment of a time-limited tolerance for an emergency
exemption. Pesticide Registration (PR) Notice 97-1, issued January 31,
1997, provides additional guidance on what data to submit to the Agency
to enable EPA to make a ``reasonable certainty of no harm''
determination in order to issue a tolerance (for a copy of PR Notice
97-1, please contact the OPP docket, address above, or visit the EPA
web site). Because EPA already has in its files much of the data it
will review to make a determination on a section 18 tolerance, the
Agency does not expect such data to be submitted routinely with an
exemption request. EPA will exercise its best scientific judgment and
rely on data submitted to support past and pending registration actions
for the subject or closely related chemical, or data submitted to EPA
as part of the reregistration process. When possible, applicants should
cite studies previously reviewed, and found acceptable by EPA, that
pertain to the requested use. EPA will not, however, conduct expedited
reviews of data submitted for permanent tolerances, or for registration
or reregistration actions, solely in order to ascertain the viability
of establishing a tolerance for a section 18 exemption request.
In all cases, applicants must include the earliest anticipated
harvest date of crops for which the section 18 exemption is being
requested. This information is useful for EPA to allocate the necessary
resources to establish the time-limited tolerances in time for the
harvest, and will also be useful to FDA and USDA in enforcing the
tolerances.
2. Agency review under a case-by-case approach. In order to
determine whether EPA will be able to establish a time-limited
tolerance for a requested section 18 use, EPA will consider available
information relevant to the factors listed in FFDCA section
408(b)(2)(D), including:
a. Aggregate exposure to the pesticide chemical residue through:
i. Dietary exposure, including drinking water.
ii. Non-dietary, non-occupational residential exposure [indoor and
out-door].
b. Cumulative effects of the pesticide chemical residue and other
substances that have a common mechanism of toxicity.
c. Extra sensitivity of infants and children.
d. Potential to produce endocrine effects.
Because there is a significant scientific uncertainty at this time
about how to aggregate non-dietary risk factors with dietary risk, and
because generally EPA has limited data with which to evaluate common
mechanism of toxicity and endocrine disruption capacities of chemicals,
EPA will make its ``reasonable certainty of no harm determination''
based on available and reliable information coupled with best
scientific judgment as necessary. If EPA concludes that establishment
of the appropriate tolerance would result in ``a reasonable certainty
of no harm'' as defined in FFDCA section 408(b), then a tolerance may
be established for the requested use.
EPA will be unable to establish a time-limited tolerance for the
proposed emergency exemption use, and therefore will deny the exemption
request, if: (1) The Agency finds that the tolerance
[[Page 29827]]
does not meet the safety standard of reasonable certainly of no harm as
defined in FFDCA section 408, or (2) the Agency does not have enough
reliable data to make a determination that the safety standard is met.
3. Alternative approaches considered. EPA has identified other
possible approaches to establishing section 18 tolerances which it
could pursue. One approach was to require a full data set to support
section 18 tolerances as is required in 40 CFR part 158, subparts D and
F, for the establishment of permanent tolerances. However, the Agency
recognized that adhering rigidly to all data specified in 40 CFR part
158, as they currently exist and as they may be modified in the future,
would effectively remove section 18 as a mechanism to address emergency
pest situations. Review and decisions would not be made in a timely or
responsive fashion, and the process of data collection, submission and
review would be equivalent to that required to establish a permanent
tolerance. This would be unduly burdensome to the applicants that
request emergency exemptions. They generally do not have resources to
develop the data themselves and so would have to rely upon data
developed by the producers of pesticide products. In sum, this approach
does not consider the emergency nature or short duration of most
exemption requests. Therefore, EPA believes that it would be
impractical, given the urgent nature of emergency conditions.
EPA also considered a minimum data set approach in which the
applicant would be required to provide a specific subset of the data
normally required to establish a full tolerance which would be
sufficient to support a safety determination given the time-limited
nature of section 18 tolerances and the urgent nature of emergency
situations. Under this approach, EPA would consider only those defined
data requirements in making a safety finding. If EPA chose to implement
the new provisions of FFDCA in this fashion, applicants would likely
have to provide specific data to EPA to support a section 18 tolerance
in addition to data which must already be submitted for emergency
exemption requests in general, outlined in 40 CFR 166.20.
EPA believes that both the creation of a new, specific minimum data
set to support section 18 time-limited tolerances, and the practical
implementation of those requirements, would result in significant
disruption to the availability of section 18 as a viable response to
emergency situations requiring use of pesticide products. EPA believes
that many applicants would have difficulty complying with a minimum
data set because these requirements would still represent levels of
technical data which most states do not have access to and currently
are unable to develop. As EPA's data requirements evolve, a defined
minimum data set might also require revision. Because a prescribed data
set is not necessary for the Agency to conclude that a tolerance is
safe and because it is EPA's belief that the amendments to FFDCA were
not intended to eliminate or significantly disrupt the availability of
emergency exemptions, EPA is not proposing to establish a minimum data
set required for tolerances associated with section 18 requests.
A fourth approach to setting tolerances under section 18 has been
suggested to the Agency. This approach was initially presented in a
paper developed by a work group of the Pesticide Program Dialogue
Committee and subsequently through a petition submitted by the National
Food Processor's Association. Under this approach, the Agency would not
conduct a full risk assessment under FQPA but would assess the
incremental risk of the proposed section 18 use. If the Agency were to
find the incremental risk insignificant, it would establish a time
limited tolerance and grant the section 18 use without conducting a
full aggregate risk assessment for the existing uses of the pesticide
chemical. This approach would take into account the limited scope and
duration of the emergency use of the pesticide. The NFPA petition
assets that limiting the Agency's review of a section 18 tolerance to
an incremental risk assessment might decrease the amount of time it
takes for the Agency to review the emergency exemption application,
thus taking into account the emergency nature and time sensitivity of
the use and potentially allowing Agency resources to be used in other
areas. In addition, the petitioners believe that the use of an
incremental risk assessment may reduce the time needed to establish a
tolerance after granting an emergency exemption. Although the Agency is
proposing to use a case-by-case approach including aggregate risk
assessment based on available data, the Agency is accepting comments on
all of these alternative approaches.
E. Publication of Tolerances
Tolerances established to support emergency exemption uses of
pesticide products would become effective upon publication of a final
rule under proposed Sec. 176.9. Shortly after promulgation of a
tolerance, EPA would publish a final rule in the Federal Register
establishing the tolerance and specifying the duration of the
tolerance. Section 408(l)(6) of the FFDCA allows EPA to establish a
tolerance without prior public notification or comment period.
Additionally, EPA intends to make tolerances established under FFDCA
section 408(l)(6) available electronically, so that there can be a
record of the most up-to-date tolerances, their expiration dates, and
any other information that can be of practical use to growers, states,
and other various enforcement agencies.
F. Duration of Tolerances
Section 408(l)(6) of FFDCA provides that tolerances for emergency
exemptions shall have an expiration date. Proposed Sec. 176.11
specifies that tolerances would expire and be revoked automatically at
such a time as determined by the Administrator. Timing of expiration
and revocation of the tolerance would be identified at the time of
establishment of the tolerance.
EPA anticipates that, typically, tolerances would not be
established for a period longer than 24 months. In its discretion, and
at its own initiative or at the request of an applicant, EPA may
establish a section 408(l)(6) tolerance for longer periods when
conditions merit such an extended time-frame. If an applicant requests
a longer time-limited tolerance for a section 18 pesticide use, the
applicant must adequately justify the requested duration when making
its emergency exemption request, and EPA would have to consider whether
the extended tolerance could pose higher risks.
G. Lawful Residues After Expiration of Tolerances
Section 408(l)(5) of FFDCA specifies that, if a tolerance for a
pesticide chemical residue in or on a food has been revoked under
section 408, food containing the residue is not unsafe if ``the residue
is present as the result of an application or use of a pesticide at a
time and in a manner that was lawful'' under FIFRA and ``the residue
does not exceed a level that was authorized at the time of the
application or use to be present on the food under a tolerance * * *
then in effect under [FFDCA]. * * * ''
Taking sections 408(l) (5) and (6) together, EPA has concluded that
the best way to effect an ``expiration date'' for a tolerance
established in connection with EPA's granting of a FIFRA section 18
emergency exemption is to specify that the tolerance will expire and be
revoked automatically, without further
[[Page 29828]]
action by EPA, as of a specified date. That date will generally be 24
months or less from the date of issuance of the emergency exemption.
After a tolerance is automatically revoked, food that contains residues
of a pesticide chemical will still be legally marketable so long as the
residues are the result of lawful use of the pesticide under the terms
of the section 18 emergency exemption and are at levels within the
tolerance established under section 408(l)(6).
Occasionally, use of the pesticide might occur before EPA actually
establishes the necessary time-limited tolerance, such as in the case
of a crisis exemption. When a time-limited tolerance is established
after the time that use of the pesticide product is authorized, the
residues on the subject commodity are only legal during the period of
time prior to the expiration and revocation of the tolerance. In other
words, there would be no ``pipeline'' provision for treated commodities
if use occurred before a tolerance was set. In case of such a gap, EPA
will consider setting a longer duration for the time-limited tolerance
to ensure that the commodity will leave channels of trade before the
tolerance expires.
EPA believes that handling the section 18-related tolerances in
this manner will allow EPA to respond promptly to emergency conditions
and will ensure that food containing pesticide residues as a result of
use under an emergency exemption will not be considered adulterated.
H. Limitations of 408(l)(6) Tolerances
Time-limited tolerances established under the authority of FFDCA
section 408(l)(6) apply to pesticide chemical residues resulting from
pesticide applications authorized by EPA under provisions of FIFRA
section 18. In addition, time-limited tolerances established under this
section will cover commodities imported into the United States during
the duration of the tolerance.
The previous establishment of a 408(l)(6 ) tolerance does not alter
the requirement for applicants to submit formal emergency exemption
requests to EPA for review. Issuing a tolerance does not grant
authority to use a pesticide, but rather provides a legal limit on
residues of the pesticide on food shipped in interstate commerce. Even
if a time-limited tolerance for a pesticide has been established in
response to one applicant's (a state, U.S. territory, or Federal
agency) emergency exemption, other applicants must obtain an emergency
exemption for the use of that pesticide if they experience a pest
emergency which requires the use of that pesticide.
VIII. Additional Section 18 Concerns Not Addressed in This Proposed
Rule
On November 21 and 22, 1996, EPA hosted a public workshop to
discuss a range of issues related to emergency exemptions from FIFRA.
The purpose of the meeting was to informally establish a dialogue
amongst and solicit the opinions of a variety of individuals and groups
affected by section 18 decisions. During this meeting, EPA encouraged
discussion of various changes that may be made to regulations governing
section 18. Although the meeting had been planned prior to the passage
of FQPA because the new law had recently been enacted, some portions of
the meeting were devoted to discussions of how implementation of FQPA
could or would affect the section 18 process. Based on the November 21-
22 meeting, there may be additional concerns regarding the section 18
program aside from the tolerance setting procedures set forth in this
proposed rule that are of great interest to many section 18
stakeholders. EPA may, at a later date, prepare a formal proposal to
make changes to the section 18 regulations.
Although this proposed rule only addresses procedures for setting
tolerances in connection with section 18 exemptions, the following
recommendations were presented to EPA by the National Association of
State Departments of Agriculture (NASDA) and the Association of
American Pesticide Control Officials (AAPCO) in a letter dated February
28, 1997, addressed to Assistant Administrator for Prevention,
Pesticides and Toxic Substances, Dr. Lynn R. Goldman, M.D. NASDA and
AAPCO prepared this letter to capture the recommendations of their
membership following EPA's November 1996 Section 18 Stakeholder
Meeting. Specifically, NASDA and AAPCO recommend that EPA implement the
following changes to the section 18 emergency exemption process:
1. Seek changes to current regulations which will allow EPA the
flexibility to base decisions on crop yield as opposed to crop value
(or profit loss) in situations where that is a better indicator of pest
damage.
2. Provide states general guidance regarding the appropriate
documentation of an ``urgent, non-routine situation'' and allow states
to certify that the ``urgent, non-routine situation'' exists based on
the guidance.
3. Implement a performance audit program to ensure compliance with
the guidance and give states justification to resist pressure to
certify an ``urgent, non-routine situation'' when it does not exist.
4. Delegate to the states authority to reissue the section 18
exemption for a second or third year, based on the state's
confirmation/certification that the basis for an emergency continues to
exist.
5. Actively support and coordinate regional section 18 requests.
6. Enter into discussions with the states to establish reasonable
monitoring criteria and approaches for wildlife and endangered species.
7. Support specific exemptions for resistance management where
there is documented scientific evidence of resistance to currently
registered pesticide or where valid research demonstrates that a
dynamic process of resistance is developing.
8. Amend 40 CFR 166.2 to include ``reduced risk'' as an acceptable
basis for granting a section 18 exemption. The definition of ``reduced
risk,'' and the requirements for this request should allow states the
ability to request a section 18 to allow for a pesticide use that will
result in a lower potential for an adverse impact on human health or
any other non-target species, including but not limited to, pest
predators, pollinators, endangered species, and other organisms of
special concern. Requests should be limited to only those situations
where the ``reduced risk'' request will not result in additional risk
to any aspect of the environment. Such requests should only be
permitted where the proposed use is highly effective so that the
potential for an increase in pesticide applications is extremely low.
As stated above, by including the recommendations of NASDA and
AAPCO in this document, the Agency is not proposing to alter existing
regulations which govern implementation of FIFRA section 18, nor is the
Agency prepared to take a position on the propriety of any of the
recommendations. EPA will accept comments on the eight recommendations
presented by NASDA and AAPCO, should individuals or organizations wish
to comment at this time. Comments on these recommendations must be
identified by the docket control number, OPP-181052, rather than the
docket number for this proposed rule.
EPA does not expect to address any comments resulting from these
eight issues in promulgating final rules establishing procedures for
setting tolerances under FFDCA section 408(l)(6), nor does the Agency
intend to allow these issues to delay implementation of the tolerance
setting
[[Page 29829]]
regulations. EPA does intend to develop a proposed rule which would
make various changes to the regulations governing section 18 exemptions
at a later date. At that time, the Agency will describe in much greater
detail these recommendations and any other changes it has considered,
and comments will be officially solicited and addressed as part of that
process.
The Agency is also seeking ideas on how to reduce the time from
when the emergency exemption is granted to when the tolerance is
established per the request of the NFPA petition.
IX. Regulatory Requirements
A. Executive Order 12866
Pursuant to Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), it has been determined that this
proposed action is not a ``significant regulatory action'' and is
therefore not subject to review by the Office of Management and Budget
(OMB). Applicants for section 18 emergency exemptions are the only
parties, other than EPA, directly affected by this proposed action.
According to the economic assessment conducted by the Agency, the
direct costs of this action are insignificant to the applicants
(Federal and state agencies) of section 18 emergency exemptions because
additional data are not readily accessible under case-by-case approach
of determining a reasonable certainty of no harm. A copy of the
economic assessment is available in the public docket for this proposed
rule.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Agency has determined that this regulatory action does not impose any
direct adverse economic impact on small entities. Applicants for
section 18 emergency exemptions are U.S. states, territories, or
Federal agencies which, by definition, are not small entities.
Applicants for section 18 emergency exemptions are the only parties,
other than EPA, directly affected by this proposed action. Therefore,
pursuant to section 605(b), the agency hereby certifies that this
action will not have a significant adverse impact on a substantial
number of small entities. Information regarding this determination will
be provided to the Chief Counsel for Advocacy of the Small Business
Administration (SBA) upon request. Any comments regarding the impacts
that this action may impose on small entities should be submitted to
the Agency at the address listed above.
C. Paperwork Reduction Act
This proposed regulatory action does not contain any new
information collection requirements that would require additional
approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
et seq. The information collection requirements that are related to
this proposed rule have already been approved by OMB under control No.
2070-0032 (EPA ICR No. 596) and control No. 2070-0024 (EPA ICR No.
597). Specifically, EPA regulations at 40 CFR part 166 allow a state,
U.S. territory, or Federal agency to apply for an emergency exemption
pursuant to section 18 of FIFRA, which would allow for a pesticide to
be used for a use for which that pesticide is not registered when such
use is necessary to alleviate an emergency condition. The regulations
set forth information requirements, procedures, and standards for EPA's
approval or denial of such exemptions. OMB has approved the information
collection requirements contained in part 166 under OMB control No.
2070-0032 (EPA ICR No. 596). In addition, EPA regulations in 40 CFR
part 180 described the process and informational needs for requesting
that the Agency establish or provide an exemption for the establishment
of a tolerance or maximum residue level for the use of a pesticide on
food crops. OMB has approved the information collection requirements
contained in part 180 under OMB control No. 2070-0024 (EPA ICR NO.
597).
The public reporting and recordkeeping burden for the collection of
information related to a section 18 exemption is estimated to average
103 hours per response annually. This estimation is based on the number
of requests for section 18 exemptions that the Agency received in
fiscal year 1996 (October 1, 1995-September 30, 1996), and the
estimated burden associated with submitting information related to a
request for the establishment of a tolerance or an exemption for a
tolerance. In FY 1996, EPA received requests for 478 emergency
exemptions pursuant to section 18. According to EPA ICR No. 597, the
Agency has estimated the annual burden to be 1,442 hours for providing
information in support of a full tolerance request under section 3 of
FIFRA.
In general, ``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. The
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. An Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires
approval under the PRA, unless it displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and 48 CFR chapter 15.
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments on the ICR to EPA as
part of your overall comments on this proposed action at the address
provided above, or to the Director, OPPE Regulatory Information
Division, Environmental Protection Agency (Mail Code 2137), 401 M St.,
SW., Washington, DC 20460, with a copy of any ICR comments to the
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. In developing the final rule, the Agency will
address any comments received regarding the information collection
requirements contained in this proposal.
D. Environmental Justice Considerations
Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994),
entitled Federal Actions to Address--Environmental Justice in Minority
Population and Low-Income Populations, 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. The Agency has found that this
proposed rule does not directly affect minority populations or low-
income groups, but will be more protective of certain subpopulations
such as infants and children.
E. Unfunded Mandates Reform Act
Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Pub. L. 104-4), EPA has determined that this action does not contain a
[[Page 29830]]
Federal mandate that may result in expenditures of $100 million or more
for State, local, and tribal governments, in the aggregate, or the
private sector in any one year. The costs associated with this action
are described in the Executive Order 12866 section above. Therefore,
this action is not subject to the requirements of sections 202 and 205
of the UMRA.
F. Enhancing Intergovernmental Partnerships
Under Executive Order 12875, entitled Enhancing Intergovernmental
Parnterships (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. Today's proposal would implement
requirements specifically set forth by the Congress in FFDCA section
408(l)(6) without the exercise of any discretion by EPA. EPA consulted
with various state officials during the development of this proposal,
including representatives from the States of North Carolina and
Washington, who acted as representatives of SFIREG.
G. Consultation and Coordination With Indian Tribal Governments
Under Executive Order 13084, entitled Consulatation 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. Today's proposal would implement requirements specifically
set forth by the Congress in FFDCA section 408(l)(6) without the
exercise of any discretion by EPA. The proposal does not significantly
or uniquely affect the communities of Indian tribal governments.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to this proposal.
H. Children's Health Protection
This proposed rule 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 that is not an
economically significant regulatory action as defined by Executive
Order 12866 (see Unit IX.A.). In addition, this proposed rule is
procedural in nature and does not involve decisions on environmental
health risks or safety risks that may disproportionately affect
children.
I. National Technology Transfer and Advancement Act
This proposed regulatory action 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.
List of Subjects in 40 CFR Part 176
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 24, 1999.
Carol M. Browner,
Administrator.
Therefore, it is proposed that 40 CFR chapter I be amended by
adding new part 176 to read as follows:
PART 176--TIME-LIMITED TOLERANCES FOR EMERGENCY EXEMPTIONS
Sec.
176.1 Scope and applicability.
176.3 Definitions.
176.5 Establishment of a time-limited tolerance or exemption.
176.7 Information needed to establish a tolerance.
176.9 Publications of a tolerance.
176.11 Duration of a tolerance.
176.13 Modification of a time-limited tolerance.
176.15 Effect of a tolerance.
Authority. 21 U.S.C. 346a and 371.
Sec. 176.1 Scope and applicability.
This part describes the procedures and criteria under which EPA
will establish time-limited tolerances and exemptions from the
requirement of a tolerance for pesticide chemical residues associated
with emergency or crisis exemptions under FIFRA section 18. This part
applies only to tolerances issued on the initiative of EPA as the
result of the issuance of an emergency exemption or the declaration of
a crisis exemption. This part does not cover time-limited tolerances in
any other circumstances.
Sec. 176.3 Definitions.
Terms have the same meaning as in the Federal Insecticide,
Fungicide, and Rodenticide Act section 2, and in the Federal Food,
Drug, and Cosmetic Act section 201 and Sec. 166.3 of this chapter. In
addition, the following terms are defined for the purposes of this
part.
Agency means the U.S. Environmental Protection Agency.
Applicant means a State, U.S. Territory, or Federal Agency that
requests an emergency exemption under Secs. 166.20 through 166.35 of
this chapter or declares a crisis exemption under Secs. 166.40 through
166.53 of this chapter.
Crisis exemption means an exemption authorized under FIFRA section
18, in accordance with Secs. 166.40 through 166.53 of this chapter.
Emergency exemption means a specific, quarantine or public health
exemption authorized under FIFRA section 18 and the regulations at
Secs. 166.20 through 166.35 of this chapter.
EPA means the U.S. Environmental Protection Agency.
FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321
et seq.)
FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. 136 et seq.)
Tolerance means the maximum amount of a pesticide chemical residue
that may lawfully be present in or on a raw agricultural commodity, or
processed food, or animal feed, expressed as parts per million by
weight of the pesticide chemical residue in the food or feed.
Tolerance exemption means a formal determination by the Agency
pursuant to FFDCA section 408(c), 21 U.S.C. 346a(c), that no tolerance
is needed for a given pesticide chemical residue in or on a particular
food commodity. For purposes of this subpart, the term ``tolerance''
shall include an exemption from the requirement of a tolerance.
Sec. 176.5 Establishment of a time-limited tolerance or exemption.
EPA will establish a time-limited tolerance for pesticide chemical
residues in or on raw or processed food
[[Page 29831]]
or feed resulting from the use of a pesticide chemical when EPA
authorizes an emergency exemption or a crisis exemption. EPA will
consider establishing such a tolerance only if an applicant under FIFRA
section 18 either has requested an emergency exemption, or has stated
its intention to declare a crisis exemption under FIFRA section 18 for
a use that may result, directly or indirectly, in pesticide chemical
residues in food or feed.
Sec. 176.7 Information needed to establish a tolerance.
(a) EPA will establish a time-limited tolerance only if EPA can
determine that the tolerance is safe, that is, there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue. EPA will base its determination upon data
submitted by the applicant and other readily available data. If, taking
into account the limited duration and emergency nature of a section 18
application, the available data are not adequate to support a
reasonable certainty of no harm determination, EPA will not establish a
tolerance.
(b) Data and other relevant information to support the
establishment of a time-limited tolerance may be submitted by the
applicant, or by any other person, in support of the time-limited
tolerance. The applicant may also cite relevant data previously
submitted to the Agency.
Sec. 176.9 Publication of a tolerance.
(a) If EPA concludes that the tolerance will be safe, it may issue
a regulation establishing the tolerance and publish a notice to that
effect in the Federal Register.
(b) A tolerance under this part may be established without prior
public notification of a proposed tolerance or comment period.
Sec. 176.11 Duration of a tolerance.
(a) Tolerances under this part become effective upon publication in
the Federal Register, unless otherwise specified by the Administrator.
(b) Tolerances will automatically expire and be revoked, without
further action by EPA, at the time set out in the Federal Register
notice estabishing the tolerance.
(c) The Administrator may revoke a tolerance at any time if the
Administrator determines that the tolerance is no longer safe.
Sec. 176.13 Modification of a time-limited tolerance.
If additional emergency or crisis exemptions are authorized that
would extend use beyond the date of expiration or revocation of a time-
limited tolerance, EPA may modify the time-limited tolerance by
extending its duration. EPA will use the same criteria and procedures
for modification as for establishing tolerances under this part.
Sec. 176.15 Effect of a tolerance.
The establishment of a tolerance under this part does not alter the
requirement that any State, U.S. Territory, or Federal Agency comply
with procedures established in part 166 of this chapter for emergency
exemptions of FIFRA.
[FR Doc. 99-14070 Filed 6-2-99; 8:45 am]
BILLING CODE 6560-50-M
