Pesticides; Emergency Exemption Process Revisions Pilot and
Request for Comment
[Federal Register: April 24, 2003 (Volume 68, Number 79)]
[Notices]
[Page 20145-20155]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap03-53]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0231; FRL-7293-6]
RIN 2070-AD36
Pesticides; Emergency Exemption Process Revisions Pilot and
Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizes EPA to issue emergency exemptions to
States and Federal agencies, allowing them to use a pesticide for an
unregistered use for a limited time if EPA determines that emergency
conditions exist. EPA is announcing and seeking comment on a limited
pilot program initiated by this Notice. The pilot is limited to
exemption applications for which the requested chemical is a pesticide
previously identified by EPA as a reduced-risk pesticide. Under this
limited pilot, EPA will allow applicants for certain exemptions to re-
certify that the emergency conditions which initially qualified for an
exemption continue to exist in the second and third years, and will
allow for a new tiered approach to be used for documenting a
``significant economic loss.'' This limited pilot is the result of
extensive stakeholder involvement and an effort to streamline the
emergency exemption process. EPA is also seeking comment on another
potential improvement to the emergency exemption program that would
provide exemptions for certain pest resistance management purposes. EPA
is considering these improvements to the emergency exemption program in
an effort to reduce the burden to both applicants and EPA, allow for
quicker decisions by the Agency, and facilitate resistance management,
while maintaining health and safety requirements. EPA currently intends
to publish a proposed rule in 2003 that will propose several potential
improvements to the emergency exemption regulations. EPA will consider
any available information from this pilot as it proceeds with
rulemaking.
DATES: Comments, identified by the Docket ID No. OPP-2002-0231, must
be received on or before June 23, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Joseph Hogue, Field and External
Affairs Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: 703-308-9072; fax number: 703-305-5884; e-mail
address: hogue.joe@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
Federal, State, or Territorial government agency that petitions EPA for
section 18 use authorization. Regulated categories and entities may
include, but are not limited to:
[sbull]
Federal Government (NAICS Code 9241), i.e., Federal
agencies that petition EPA for section 18 use authorization.
[sbull]
State or Territorial governments (NAICS Code 9241), i.e.,
States, as defined in FIFRA section 2(aa), that petition EPA for
section 18 use authorization.
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 North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the summary of the applicability provisions as found
in Unit III.B. of this Notice. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed in the FOR FURTHER INFORMATION CONTACT section.
B. How Can I Get Copies of this Notice and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under Docket ID No. OPP-2002-0231. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall i
2, 1921 Jefferson Davis Highway, Arlington, VA.
This Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is 703-
305-5805.
2. Electronic access. You may access this Federal Register Notice
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.regulations.gov/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket identification number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA
[[Page 20146]]
intends to work towards providing electronic access to all of the
publicly available docket materials through EPA's electronic public
docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the Docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket identification number in the subject line on the
first page of your comment. Please ensure that your comments are
submitted within the specified comment period. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments. If you wish to submit CBI or
information that is otherwise protected by statute, please follow the
instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit
CBI or information protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed below, EPA recommends that you include your name, mailing
address, and an e-mail address or other contact information in the body
of your comment. Also include this contact information on the outside
of any disk or CD ROM you submit, and in any cover letter accompanying
the disk or CD ROM. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. EPA's policy is that EPA
will not edit your comment, and any identifying or contact information
provided in the body of a comment will be included as part of the
comment that is placed in the official public docket, and made
available in EPA's electronic public docket. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in Docket ID No.
OPP-2002-0231. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by electronic mail (e-mail) to
opp-docket@epa.gov, Attention Docket ID No. OPP-2002-0231. In contrast
to EPA's electronic public docket, EPA's e-mail system is not an
``anonymous access'' system. If you send an e-mail comment directly to
the Docket without going through EPA's electronic public docket, EPA's
e-mail system automatically captures your e-mail address. E-mail
addresses that are automatically captured by EPA's e-mail system are
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Mail Code: 7502C, 1200 Pennsylvania
Ave., NW., Washington, DC 20460, Attention Docket ID No. OPP-2002-0231.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
i
2, 1921 Jefferson Davis Highway, Arlington, VA, Attention
Docket ID No. OPP-2002-0231. Such deliveries are only accepted during
the Docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person identified in the FOR FURTHER INFORMATION CONTACT section.
II. Purpose of this Notice
This Notice announces the implementation of and seeks public
comment on a limited pilot starting with the 2003 growing season. The
pilot involves two potential process improvements to the emergency
exemption program that are the result of an effort to streamline the
emergency exemption process. EPA is taking this action after extensive
stakeholder involvement (see Unit IV.). The pilot is limited to
exemption applications for which the requested chemical is a pesticide
previously identified by EPA as a reduced-risk pesticide. Under the
limited pilot, EPA will allow applicants for certain exemptions to re-
certify (and incorporate a previous application's information by
reference) that the emergency conditions which initially qualified for
an exemption continue to exist in the second and third years, and will
allow for a new tiered approach to be used for documenting a
``significant economic loss.'' EPA is also seeking
[[Page 20147]]
comment on another potential change being considered for the emergency
exemption program, i.e., whether to allow exemptions for pest
resistance management purposes.
EPA is considering these improvements to the emergency exemption
program regulations in 40 CFR part 166 in an effort to reduce the
burden to both applicants and EPA, allow for quicker decisions by the
Agency, and facilitate pest resistance management, while maintaining
health and safety requirements. EPA currently intends to publish a
proposed rule in 2003 that will propose several potential improvements
to the emergency exemption regulations. EPA will consider any available
information from this pilot as it proceeds with rulemaking.
The potential revisions to the emergency exemption process
described in this Notice arose from an effort to evaluate the emergency
exemption regulations at 40 CFR part 166, begun in 1995. As part of
that effort, in November 1996, the Agency hosted a Section 18
Stakeholders Workshop to discuss possible improvements to the Agency's
emergency exemption process and receive stakeholder input. The
improvements discussed at the workshop, and those included in this
Notice, directly affect only applicants for emergency exemptions.
States are the primary applicants for emergency exemptions, although
Federal agencies may also apply.
Recommendations from the Association of American Pest Control
Officials (AAPCO) Section 18 Task Force, representing the States, are
the general basis for EPA's plan announced by this Notice. AAPCO
originally provided EPA with recommendations following the 1996
workshop and recently submitted a revised, shortened list of three
recommendations. This Notice begins to address those three
recommendations. EPA has carefully refined each recommendation in an
effort to address concerns expressed by other stakeholders. In refining
those recommendations, the Agency attempted to maximize the
streamlining benefits while making sure it can still carry out its
health and safety responsibilities. A discussion of the evaluation
process leading up to this Notice, including stakeholder input and
recommendations, is in Unit IV.
After receiving comment on this Notice or near the end of the first
year under the pilot, EPA plans to again consult the Pesticide Program
Dialogue Committee (PPDC) on the potential improvements discussed in
this Notice. At that time, the Agency, applicants for emergency
exemptions, and many others will be able to share and discuss their
experiences concerning the pilot provisions. The diverse group of
stakeholders represented at PPDC meetings provides an excellent source
of feedback to the Agency. Input from the PPDC will be carefully
considered, along with public comments received in response to this
Notice, public comments on the proposed rule expected in 2003, and
experience from the pilot, when deciding what will be included in the
final rule.
The following is a summary of the statutory and regulatory
framework of the Emergency Exemption Program, a description of the
extensive stakeholder involvement that forms the basis for the limited
pilot and this request for comment, a detailed description of the
limited pilot, and the Agency's request for comment.
III. Existing Statutory and Regulatory Framework
A. Statutory Provisions--FIFRA Section 18
Section 18 of FIFRA gives the Administrator of EPA broad authority
to exempt any Federal or State agency from any provision of FIFRA if
the Administrator determines that emergency conditions exist which
require such exemption.
B. Regulatory Provisions--40 CFR Part 166
Regulations governing such FIFRA section 18 emergency exemptions
are codified 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 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 apply to 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 requested or granted under section 18 fall under the category of
``specific exemptions.'' Typical justifications for specific exemptions
include, but are not limited to, 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
pests to a registered product, or loss of efficacy of available
products for any reason. 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 applies to EPA under section 18, it
must submit a request in writing that documents the emergency
situation, the pesticide proposed for the use, the target pest, the
crop, the rate and number of applications to be made, the geographical
region where the pesticide 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 food, drinking water, and residential
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 water 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
concludes that the situation is an emergency, and that the use of the
pesticide under the exemption will be consistent with the standards of
the Food Quality Protection Act (FQPA) and 40 CFR part 166, 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 viewed 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
[[Page 20148]]
registration or seek a new registration to address that future need.
IV. Background and Summary of Stakeholder Feedback
A. 1996 Section 18 Workshop to Streamline Emergency Exemption Process
In 1995, as part of an effort to streamline regulations, the Agency
began a process to evaluate the emergency exemption regulations at 40
CFR part 166, and to formulate recommended changes to the operating
procedures. As part of that effort, in November 1996, the Agency hosted
a Section 18 Stakeholders Workshop to discuss possible regulatory
changes to the Agency's section 18 process and receive stakeholder
input. Participants of that meeting included representatives from State
agencies responsible for pesticide oversight, chemical companies, and
environmental and public interest groups. Participants voiced their
concerns and identified suggestions for improving the emergency
exemption process.
Although EPA scheduled the section 18 workshop prior to passage of
the FQPA, in August 1996, the workshop was held shortly after the law
was enacted. Because FQPA included new requirements affecting emergency
exemptions, and was just 3 months old at the time of the workshop, the
new law was of great interest to participants. Stakeholders at the
workshop were deeply concerned that the new requirements of FQPA would
hurt both the Agency's review time and approval rate for exemption
requests, as well as increase the burden on applicants (primarily
States) for information and documentation. Several of the
recommendations raised in the workshop addressed these three concerns.
B. NASDA/AAPCO Initial Recommendations to EPA for Improvements
Subsequent to the November 1996 Section 18 Stakeholders Workshop,
the National Association of State Departments of Agriculture (NASDA)
and the Association of American Pest Control Officials (AAPCO) jointly
sent a letter to EPA to provide recommendations for changes to the
emergency exemption process. The letter referred to recommendations
contained in a series of NASDA Proposed Resolutions. A copy of that
letter and the Proposed Resolutions are available in the public docket
for this Notice. The NASDA/AAPCO recommendations, which generally
summarized issues raised at the workshop, were:
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 pesticides 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.
The NASDA Proposed Resolutions also included recommendations
concerning the establishment of time-limited tolerances for residues in
food of pesticides used under emergency exemptions. Tolerances for
pesticide uses under section 18 have already been addressed separately
by EPA, as FQPA required that the Agency publish a regulation to put in
place a process for that purpose. Therefore, the NASDA/AAPCO
recommendations concerning tolerances are not included in this
discussion.
C. The Food Quality Protection Act and Evolution of the Emergency
Exemption Program
FQPA included new requirements affecting emergency exemptions, as
stated above. FQPA set a new safety standard, and, for the first time
required time-limited tolerances for pesticide residues in food
resulting from pesticide use under emergency exemptions. As a result of
FQPA, each emergency exemption request must be evaluated based on the
potential risk to human health and the environment, including the
aggregate risk to the public from ingestion of treated food, pesticide
residues in drinking water, and exposure to the pesticide in and around
the home and other non-occupational settings.
Processing time for emergency exemption requests (days from receipt
of request to decision) increased significantly in 1997, the first year
after FQPA, as EPA developed methodology to implement section 18 under
the new law. Due to the urgent nature of emergency exemption requests,
the Agency worked very hard to streamline the process. Average
processing time decreased to pre-FQPA rates in 1998, and has decreased
each year since then. The average processing time for exemption
requests reached an all-time low of 44 days in 2000, for the first time
surpassing the Agency's goal of 50 days, and decreased again to 34 days
in 2001.
The approval rate for exemption requests is similar to pre-FQPA
levels. The number of exemption requests has increased sharply since
1996, as have the number of exemptions granted. EPA believes the burden
on applicants to request any individual emergency exemption has not
increased since the recommendations were made, and in some cases it has
decreased. The Agency has worked hard to be flexible with applicants,
to make full use of existing data, and to minimize documentation
requirements where appropriate, with particular attention to issues
raised in the NASDA/AAPCO recommendations. Although FQPA did not
appreciably increase applicant burden in preparing any specific
emergency exemption request, the Agency is always interested in
improving and streamlining its processes.
[[Page 20149]]
D. Stakeholder Feedback and EPA Response Since Workshop and Initial
Recommendations
Since the Section 18 Stakeholders Workshop in 1996 and receipt of
the NASDA/AAPCO recommendations, EPA has worked closely with
stakeholders to develop the best approach to address the
recommendations. Adoption of any of the recommendations would primarily
affect applicants for emergency exemptions. Because only States, U.S.
territories, and Federal agencies can apply for emergency exemptions,
EPA has had the rare opportunity to work very closely with a large
percentage of the parties affected by a procedural change to gain
valuable, ongoing feedback during the effort to develop the potential
improvements discussed in this Notice.
After the initial NASDA/AAPCO recommendations were submitted, a
workgroup consisting of EPA staff and several representatives of State
agencies responsible for pesticide oversight met regularly to develop
specific options to address each of the recommendations. During this
time and subsequently, the Agency looked for ways to improve the
process and further expedite decisions on requests. EPA reviewed the
NASDA/AAPCO recommendations, and the options developed by the
workgroup, to determine what could be accomplished through non-
regulatory internal process improvements. These efforts paid off in
repeatedly shortened average review times for emergency exemption
requests.
Due to the significant improvements in the emergency exemption
process and program during the several years following the original
NASDA/AAPCO recommendations, the needs of the States changed. The AAPCO
Section 18 Task Force has reviewed the past set of recommendations and
recently provided updated, final State recommendations for improving
the emergency exemption program (see Unit IV.E.). Each of the original
eight recommendations has either been intentionally excluded by AAPCO
in their final three recommendations, or is being addressed in this
Notice. AAPCO's letter with the final recommendations acknowledged
that, based on several years of experience with the section 18 process
under FQPA, they no longer suggested that EPA pursue the other initial
recommendations. The initial recommendations numbered 1, 4, and 7 (see
Unit IV.B.) are addressed in this Notice. The second and third of the
initial recommendations were designed to be implemented together, and
were essentially another option for the fourth, which AAPCO ultimately
favored. EPA does encourage and help to coordinate regional emergency
exemption requests involving multiple States, which was the fifth
recommendation. Concerning recommendation number six, EPA is continuing
to work with States to develop monitoring criteria for wildlife and
endangered species in the context of pesticide registration. While the
eighth recommendation, to allow exemptions based on reduced risk, has
not been adopted, EPA does take reduced risk benefits into account as a
factor in decisions.
EPA also solicited public comments on the original NASDA/AAPCO
recommendations to improve the emergency exemption process, in the
preamble to the proposed rule titled ``Tolerances for Pesticide
Emergency Exemptions'' (64 FR 29823, June 3, 1999) (FRL-5750-1). The
Agency only received comments on the listed recommendations from four
parties. Two of the commenters were State departments of agriculture.
Both States generally agreed with all the recommendations, but in
particular supported the three revisions addressed in this Notice. One
State offered refinements to several of the recommendations.
The other two commenters were public interest groups. Both groups
opposed all of the recommendations. However, EPA believes that the
operational revisions to the process being piloted have been refined in
such a way as to address most of the concerns stated in their comments.
One group noted that the current emergency exemption regulations are
the result of negotiated rulemaking, a process which included a
balanced representation of interests, but that the Section 18
Stakeholders Workshop, which culminated in the NASDA/AAPCO
recommendations was not an adequately open process. EPA believes the
workshop included participants from a wide array of interests, as
representatives from State agencies responsible for pesticide
oversight, chemical companies, and environmental and public interest
groups attended. Also, the Agency's plan to undertake notice-and-
comment rulemaking procedures before adopting any final changes to the
section 18 process will again allow all interested parties to
participate in the development of the potential changes.
In May 2002, EPA presented its general plan concerning the three
revisions to the emergency exemption process included in this Notice to
the PPDC. The PPDC provides a forum for a diverse group of stakeholders
to provide feedback to EPA on various pesticide regulatory, policy, and
program implementation issues. A wide array of stakeholders provided
comments at the May meeting, which EPA has considered in refining the
pilot and proposed revisions in this Notice. A transcript of the
presentation and discussion at the May PPDC meeting is in the public
docket for this Notice.
E. Final Recommendations by AAPCO Section 18 Task Force
AAPCO provided EPA with their updated recommendations for improving
the emergency exemption process:
1. Multi-year section 18 exemptions. EPA should delegate authority
to the States to reissue section 18 exemptions for a second or third
year, based on the State's confirmation that the basis for an emergency
situation continues to exist.
2. Resistance management. EPA should support specific exemptions
for pest resistance management where there is documented scientific
evidence of resistance to currently registered pesticides or where
valid research demonstrates that resistance is developing.
3. Criteria for significant economic loss. EPA should base
decisions on crop yield rather than crop value (or profit loss) in
situations where crop yield is a better indicator of pest damage.
These are three of the eight recommendations originally submitted
to the Agency in 1997. These updated recommendations were provided to
EPA by AAPCO, verbally at the May 2002 PPDC meeting, and again in a
letter in September 2002, from the president of AAPCO. A copy of that
letter is available in the public docket for this Notice. The three
potential revisions discussed in this Notice would essentially address
these three recommendations, albeit with modifications based on input
from other stakeholders. Each of the initial eight recommendations has
either been dropped by AAPCO in their final recommendations, or is
being addressed in this Notice.
V. Limited Pilot of Potential Process Improvements Beginning with the
2003 Growing Season
This limited pilot was developed after long and careful
consideration of input by stakeholders. EPA believes that the changes
being piloted will significantly benefit both applicants for pesticide
emergency exemptions and the Agency. These benefits are expected to
accrue without any increase in risk to human health or the environment.
The pilot
[[Page 20150]]
will also provide valuable information that will aid the Agency in
developing and completing regulatory revisions related to these process
improvements, which the Agency currently expects to propose in 2003.
A. Which Emergency Exemptions will be Included in the Pilot?
The pilot will be limited to emergency exemption applications for
which the requested product is a pesticide previously identified by EPA
as a reduced-risk pesticide, as discussed below. The pilot will only
involve specific exemptions, and does not affect public health or
quarantine exemptions. The pilot will begin with emergency exemptions
for the 2003 growing season. As such, EPA will consider the two process
improvements when it reviews eligible applications for emergency
exemption for the 2003 growing season, including those applications
that are currently pending final decision on and any applications
received after April 16, 2003. The Agency recognizes that those
applications currently under review by EPA that are eligible for the
pilot, are not likely to include information that addresses the two
improvements described in this Notice. In such cases, the Agency
intends to work with the applicants to apply the pilot provisions where
appropriate and desired by the applicant. It should be noted that at no
time during the pilot is any applicant required to use the pilot
provisions, even if eligible. Any applicant which chooses to forgo the
pilot and use the established application process may do so.
EPA chose to focus the pilot on reduced-risk pesticides, a specific
set of pesticide products which includes conventional pesticides which
were registered under EPA's Reduced-Risk Pesticide Initiative, plus
biological pesticides registered through the Biopesticides and
Pollution Prevention Division (BPPD). The goal of the Reduced-Risk
Pesticide Initiative and BPPD is to encourage the development,
registration, and use of lower-risk pesticide products which would
result in reduced risks to human health and the environment when
compared to existing alternatives. A detailed description of reduced-
risk pesticides may be found in Pesticide Regulation Notice 97-3, which
is available in the public docket for this Notice. The reduced-risk
determination for conventional pesticides is made by EPA for each use
of a pesticide, particularly when compared to existing registered
alternatives for that use. However, for use in implementation of the
revised practices under the pilot in this Notice, any active ingredient
which is contained in at least one product registered under the
Reduced-Risk Initiative, plus any biological pesticide, will be
considered a reduced-risk active ingredient. Any product containing one
or more of these active ingredients and no others will be eligible,
while any product containing any other active ingredient will not be
eligible for exemption under the pilot.
EPA has prepared a list of all reduced-risk active ingredients, as
defined above, so that applicants and others may easily determine which
emergency exemption requests may be eligible for consideration under
the pilot for the revised approach for documentation of significant
economic loss. The new economic loss approach under the pilot may be
applied to any exemption request for a reduced-risk pesticide on this
list. However, in order for exemptions to be eligible for re-
certification of an emergency under the pilot, in addition to the
restriction to reduced-risk pesticides, they must also meet the other
criteria for candidacy for re-certification set forth in Unit V.B.1.
Therefore, the Agency has prepared a second list of existing (i.e.,
granted for use in 2002) exemptions that are eligible for re-
certification. EPA has also prepared a guidance document for
implementation of the revised practices under the pilot, which is
intended to further aid applicants in preparing applications. The two
lists for determining eligibility of exemptions under the pilot are
appendices to the guidance document, which will be sent to the States
and included in the public docket for this Notice.
B. What Process Improvements are Being Piloted?
Two potential improvements to the emergency exemption program will
be tested through this limited pilot.
1. Re-certification of emergency condition by applicants--i. What
is our current practice? EPA authorizes emergency exemptions (except
quarantine exemptions) for no longer than 1 year. However, depending on
the nature of the non-routine condition which caused the emergency,
some exemptions may subsequently be granted again, 1 year at a time.
Currently, EPA conducts a full review of an application for the first
year of an exemption, to determine whether an emergency condition
exists, to ensure the use will not result in unreasonable adverse
effects to man or the environment, and, if the use will result in
pesticide residues in food or feed, to make a safety finding consistent
with section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
Applicants may submit an application for a subsequent year, in which
case the Agency must again confirm the emergency condition and
acceptability of the risk. For requests after the first year, the
applicant again submits information to support the emergency finding,
and EPA reevaluates the situation to determine, relative to the first
year, whether: (1) The emergency condition has changed; (2) any
alternative products have been newly registered for the use, or other
effective pest control techniques are now available; (3) any changes
have occurred in the status of the chemical's risk assessment; and (4)
the requested use pattern has changed.
ii. How will re-certification work under the pilot? The first
potential improvement that is part of the pilot will allow applicants
for certain exemptions to re-certify in the application that the
emergency conditions which initially qualified for an exemption
continue to exist in the second and third years. Under the pilot, this
re-certification by the applicant will serve as the basis for EPA's
determination that an emergency condition continues to exist. An
acceptable application which re-certifies the emergency will
incorporate by reference all information submitted in a previous
application or applications to document the initial emergency condition
for which an exemption was granted previously. Eligible applications in
years two and three may consist only of applicants' re-certification of
the emergency condition, incorporation by reference of supporting
materials, and specification of the pesticide application practices
that growers would observe. Applicants would not need to submit new
documentation that the emergency condition continues or the additional
data elements generally required under 40 CFR 166.20.
EPA will apply specific criteria to determine whether an exemption
request will be eligible for re-certification of the emergency
condition by the applicant. All of the following criteria need to apply
in order for EPA to consider an exemption as a candidate for re-
certification of an emergency under the pilot:
1. EPA granted the same exemption the previous year, and it is the
second or third year of the request by that applicant. The Agency
determined that the situation the previous year satisfied requirements
for an emergency condition (40 CFR 166.3(d)). A complete application
will be required the first year of an exemption for a particular
[[Page 20151]]
applicant, in order to establish the existence of the emergency. Re-
certifications will not be accepted as the basis for an emergency after
3 years of an exemption to an applicant.
2. The emergency situation can reasonably be expected to continue
for longer than 1 year. Examples of these include situations where a
registered product relied upon by growers becomes permanently
unavailable; expansion of a pest's range; and, documented loss of
efficacy of a registered product. Situations which would not be
expected to continue would include a temporary supply problem of a
registered product; an isolated weather event; and a sporadic pest
outbreak.
3. The exemption is not for a new chemical, a first food use, or
for a chemical under Special Review. An exemption that is for a product
containing an active ingredient which has never been contained in a
product registered as a pesticide under section 3 of FIFRA, or has
never been registered for a food use, has officially been placed under
Special Review by the Agency, or has been the subject of a Notice of
Intent to Cancel under FIFRA section 6, would not be considered for
candidacy for re-certification of the emergency.
4. The requested pesticide is registered for another use and has
been designated as ``reduced-risk'' by EPA for one or more uses. The
reduced risk program is explained in PR Notice 97-3. This program
offers pesticide manufacturers incentives for developing registration
applications for pesticides which are less risky than the alternatives
for a given pest problem. A committee of EPA scientists evaluates and
selects pesticides and uses which are considered to be reduced risk.
Under the pilot, EPA will accept re-certifications of emergency
conditions for exemptions which satisfy the eligibility criteria
described above. It may not be clear to applicants whether some
exemptions are eligible for re-certification. Since eligibility
determinations must be made by the Agency, EPA has developed a list of
emergency exemptions granted for use in 2002 that appear to be
candidates for re-certification for the 2003 growing season. This list
(included in the guidance document available in the public docket) is
intended to help avoid an applicant's assumption that an exemption is
eligible for re-certification of the emergency, when in fact it is not.
EPA will attempt to include all appropriate candidates on this list.
However, applicants may contact the Agency to request an eligibility
determination for exemptions they believe satisfy the criteria but
which are not on the list.
For applications which are eligible and include a proper re-
certification of the emergency condition, EPA will continue to assess
whether the requested use poses a risk to human health or the
environment that exceeds statutory and regulatory standards. If the
risks posed by the requested use are determined to be unacceptable, the
exemption request will be denied. However, when the emergency condition
and requested use in an eligible year are the same as in the initial
year of the exemption, EPA will only re-evaluate the situation to
determine, relative to the first year, whether: (1) Any alternative
products have been newly registered for the use; (2) any changes have
occurred in the status of the chemical's risk assessment; and (3) the
requested use pattern has changed. If an effective product has been
registered for the requested use since the previous exemption was
granted, then an emergency condition no longer exists. If the Agency
has received new risk information since granting the previous
exemption, then the risk will be re-evaluated. Likewise, if the request
includes any change in the use pattern which may increase exposure
(application rate, number of applications, type of application, pre-
harvest interval, re-entry interval, total number of acres, and all
other directions for use) then the risk will also be re-evaluated.
For eligible requests with applicant certification of a continuing
emergency, if the three remaining review factors (product
registrations, risk assessment status, and requested use pattern) have
not changed, the Agency's review time is expected to be significantly
reduced. In such cases, applicants are expected to benefit by expedited
decisions, in addition to the reduced burden due to the certification
of the emergency. Applicants will be permitted to modify the use
pattern for the emergency program in an application in which they re-
certify the emergency. However, EPA will need to determine whether, and
how, such changes impact exposure and risk to human health or the
environment. Therefore, these changes may undercut the ability of
applicants to receive an expedited Agency decision. If the use pattern
is the same as in the first year, applicants may include a separate
certification that their requested use pattern has not changed in the
re-certification year, and incorporate by reference all use pattern
specifications submitted in a previous application or applications.
This certification of an unchanged use pattern will aid in expediting
the Agency's decision.
If the Agency determines that there has been insufficient progress
towards registration of the requested chemical on the requested crop, a
request could be denied, consistent with current regulations and
practice, regardless of eligibility for re-certification. Progress
toward registration is determined for a pesticide-crop combination,
whereas the year-count (first, second, third, etc.) in the eligibility
cycle for re-certification would be determined separately for each
applicant, and could often differ among applicants in a given year.
Lack of progress towards registration would generally not cause denials
during the first 3 years of exemptions for a chemical-crop combination.
However, since some applicants may apply for the first time, in a year
subsequent to the first request for a chemical-crop combination by
another applicant, lack of progress towards registration could
potentially interrupt the eligibility cycle for some applicants.
EPA is sensitive to emergency exemption requests being repeated for
a number of years and requires that steps be taken to obtain a
registration for the emergency use. Under this pilot for re-certifiable
emergencies, EPA will not allow re-certification of emergencies for
exemptions that have been granted for more than 3 years.
iii. Why pilot this potential improvement? Allowing applicants to
re-certify the existence of an ongoing emergency condition for certain
eligible exemption requests is expected to reduce the burden to both
applicants and EPA as well as allow for quicker decisions. When an
applicant certifies the continuation of the emergency condition and
incorporates previously submitted materials by reference, a complete
new application sufficient to characterize the situation in accordance
with 40 CFR 166.20 will not be required. This will save applicants time
and effort in gathering data and preparing their submissions. The
Agency will save time and resources by not having to annually repeat
the analyses that support the applicable requests. If no pesticides
which can avert the emergency have been newly registered, and nothing
has changed to affect the assessment of risk, then re-certification of
an emergency will lead to significantly shorter Agency review, saving
valuable time for those affected by the emergency.
EPA's experience indicates that emergency situations which continue
after the initial year generally cause comparable losses in succeeding
years. Therefore, with the certification of a
[[Page 20152]]
continuing emergency, the economic data and other supporting
information required by 40 CFR part 166 would be unnecessary.
The limited focus of the pilot on reduced-risk pesticides will
significantly reduce the number of exemptions potentially affected
under the pilot. Nevertheless, the Agency expects the pilot to provide
valuable experience. Any available information from the pilot will be
considered along with public comments in forming a better proposed rule
that EPA currently intends to issue in 2003 and aid in the development
of final improvements to the emergency exemption program.
2. Tiered approach for documentation of ``significant economic
loss''--i. What is our current practice? EPA determines whether the
loss from an emergency would result in net cash returns (gross revenue
less operating expenses) below the historical variation in net cash
returns. Applicants are required to submit economic information
necessary to make this determination, when available. In addition to
information used to estimate the amount of the anticipated yield and
profit losses, annual data for 5 years of average yields, prices, and
production costs are submitted by applicants and analyzed by EPA to
establish profit variability.
ii. How will the tiered approach to determining significant
economic loss be used under the pilot? A large majority of emergency
exemptions are granted because they meet the regulatory criteria for an
emergency condition that affected growers will suffer a ``significant
economic loss'' due to an urgent, non-routine situation if the
requested exemption is not granted. This second potential improvement
that is part of the pilot will allow applicants to develop the
significant economic loss documentation necessary to support many
specific exemption requests through a less burdensome economic
methodology.
This tiered approach is based on an analysis of data found in a
random selection of past requests for emergency exemptions submitted by
States, including requests that were denied. The analysis shows that in
many cases significant economic loss can be demonstrated in a more
flexible manner without loss of reliability. The analysis of past
section 18 requests suggests that the current approach is often
unnecessarily burdensome in terms of information requirements. This new
approach under the pilot will often reduce the burden to applicants
relative to the current approach, while maintaining the level of
approvals of current regulations. The tiered approach is intended to
require less data from applicants in cases where the same conclusion of
a significant economic loss would be made with the additional data and
analysis.
Current regulations (40 CFR 166.20(b)) list certain information
which must be included, as appropriate, in an application for a
specific exemption:
(b) Information required for a specific exemption. An
application for a specific exemption shall provide all of the
following information, as appropriate, concerning the nature of the
emergency:
(4) A discussion of the anticipated significant economic loss,
together with data and other information supporting the discussion,
which addresses all of the following:
(i) Historical net and gross revenues for the site;
(ii) The estimated net and gross revenues for the site without
the use of the proposed pesticide; and
(iii) The estimated net and gross revenues for the site with use
of the proposed pesticide.
The regulations state that all of the above information must be
included ``as appropriate.'' EPA exercises judgement based on
experience, in determining when something less, or different, is
appropriate. For example, under the current approach the Agency
typically considers 5 years of annual data on historical net and gross
revenues to be appropriate, although the regulations do not prescribe 5
years. However, in some cases, such as a very minor or new crop for
which less data are available, this requirement is not considered
appropriate if the applicant substitutes other credible information.
Therefore, EPA believes that the pilot approach will allow applicants
to focus their applications on the most ``appropriate'' information for
determining whether or not a significant economic loss will occur.
Because the analysis of past exemption requests, on which the pilot
approach is based, demonstrates that the likelihood of approval of some
requests is not significantly changed by the pilot tiered approach, EPA
believes that the requirement of those data in those cases is not
appropriate. However, even when annual historical data are not
required, applicants would generally continue to utilize historical
data under the pilot approach, albeit in a different way. Each tier
requires a quantitative threshold to be met, which is a certain
percentage of a baseline of either crop yield, gross revenues, or net
revenues. The best approach to determine the baseline in most cases is
to use the average of historical data, including yield and price data.
Whereas the existing method generally requires detailed historical
data, with the new approach the analytical burden for determining
significant economic loss will be divided into three successive tiers.
If the pest situation does not appear likely to result in a significant
economic loss based on the first tier analysis, it could qualify based
on further analysis in succeeding tiers. Each additional tier would
require more data and involve more analysis on how the emergency
affects profitability. For a loss to be considered economically
significant, it must exceed a threshold. Each tier has a quantitative
threshold that will generally apply to all eligible emergency exemption
applications. Where conditions do not neatly fit into the tiered
approach, for example long-term losses in orchard crops, the Agency may
make a finding of significant economic loss based on other criteria,
such as changes in the net present value of an orchard, if these losses
are demonstrated by the State.
Tier 1--Yield Loss. Tier 1 is based on crop yield loss. If the
projected yield loss due to the emergency condition is sufficiently
large, EPA will conclude that a significant economic loss will occur,
due to the magnitude of the expected revenue loss. The yield loss
threshold in Tier 1 will be 20% for all crops. This threshold is set at
a sufficiently high level such that a loss which exceeds the threshold
will also meet the thresholds in Tiers 2 and 3, if the additional
economic data were submitted and analyzed. Therefore, for such large
yield losses it will not be appropriate or necessary to separately
estimate economic loss, which requires detailed economic data.
Tier 2--Economic Loss as a Percentage of Gross Revenues. A yield
loss which does not satisfy the threshold in Tier 1 could also lead to
a significant economic loss because yield loss may not capture all
economic losses. In addition to yield losses there may be other impacts
that affect economic loss, including quality losses and changes in
production costs, such as pest control costs and harvesting costs. For
situations with yield losses that do not meet the significant economic
loss criterion for Tier 1, EPA will evaluate estimates of economic loss
as a percent of gross revenue in Tier 2, to determine if the loss meets
that threshold for a significant economic loss. The economic loss
threshold in Tier 2 will be 20% of gross revenue for all crops. Again,
this threshold in Tier 2 is set with the intention that losses
exceeding the threshold also meet the threshold in Tier 3, if it were
analyzed.
[[Page 20153]]
Tier 3--Economic Loss as a Percentage of Net Revenues. Because
typical profit margins (net cash revenues as a percentage of gross
revenues) vary among crops, EPA will consider impacts on net cash
revenues in Tier 3 if neither yield or economic losses are above the
required thresholds in Tiers 1 and 2. Specifically, Tier 3 will measure
economic loss as a percent of net cash revenues. The loss threshold in
Tier 3 will be 50% of net cash revenues for all crops during the pilot.
Some emergency conditions which fall short of the thresholds in Tiers 1
and 2 may qualify as a significant economic loss in Tier 3,
particularly for crops with narrow profit margins. Even if economic
loss seems small in comparison to gross revenues, the situation could
still be determined to be a significant economic loss if the profit
margin is narrow.
For those emergency exemptions in which significant economic loss
is a qualifying factor, applicants will determine which tier their
situation is expected to qualify under, specify that tier in their
request, and submit the data necessary for analysis under that tier.
The three tiers are designed such that when an emergency condition
qualifies for significant economic loss under a lower tier, data for
higher tiers is not required, and the burden and cost are reduced. Each
successive tier builds upon the previous one. That is, the information
required for estimating a lower tier is also necessary in estimating
each higher tier. This will allow an applicant to collect data, and
build a case for significant economic loss, as needed and determined by
the conditions.
iii. Why pilot this potential improvement? This new methodology for
determining a significant economic loss is intended to streamline the
data and analytical requirements for emergency exemption requests. In
addition, the methodology is designed to be more flexible than the
existing procedure for determining a significant economic loss.
Specifically, the Agency believes this approach makes a better
comparison between the emergency situation and what would exist without
the emergency, rather than a comparison with the past. An analysis of
past section 18 requests suggests that this new approach will not cause
a significant change in the overall likelihood of a significant
economic loss finding, although findings may differ in individual
cases. Further, it is expected to lead to considerable savings to both
applicants and EPA from reduced data and analytical burdens. Under the
pilot procedure, applicants may elect to submit the minimum amount of
data necessary to demonstrate a significant economic loss in one of
three increasingly refined tiers. If the first tier is sufficient, the
burden is reduced most significantly. Even in the highest tier, the
burden may be reduced relative to the old approach as the analysis
focuses on the current year rather than historical data. Like re-
certification of emergencies, this will save applicants time and
resources in gathering data and preparing submissions. The Agency's
burden will be reduced due to streamlined reviews.
As with re-certification of emergencies, the Agency expects the
pilot to provide useful experience with the tiered approach for
documentation of significant economic loss. That experience will be
considered along with public comments to assist in the planned
rulemaking process for improving the emergency exemption regulations.
The Agency will analyze the selected threshold levels during the pilot
period to confirm that they are appropriate, and also use any helpful
information supplied in public comments. EPA will also scrutinize the
approach of using a uniform threshold level in each tier for all crops,
and consider whether different levels for various crop groups would be
more appropriate.
VI. Request for Comment
A. Comment Sought on Improvements Being Piloted
The Agency seeks comment on the potential changes included in the
limited pilot described in Unit V., and on how those provisions should
be implemented through a future rulemaking. EPA currently intends to
publish a proposed rule in 2003 that will propose several potential
improvements to the emergency exemption regulations. EPA will consider
any available information from this pilot as it proceeds with
rulemaking.
If the re-certification process is fully implemented through
rulemaking, the eligibility criteria established in that rulemaking
would become final, and may differ from the criteria under the pilot.
The Agency expects that after such a final rule, whenever EPA granted
an exemption, and classified it as a candidate for re-certification, it
would also include in the approval letter the number of years of
candidacy remaining at that time (i.e., 1 or 2 years). This
notification in the approval letter of candidacy for the following year
will not occur during the pilot, as the criteria under the pilot are
not final. Instead, EPA will prepare a list of candidate exemptions
(see Unit V.A.) for each year that the pilot is in effect.
The scope of the pilot is purposely limited to reduced-risk
pesticides in order to significantly reduce the number of exemptions
potentially affected, while still benefiting from the experience of the
potential improvements to inform the rulemaking process. However, EPA
does not anticipate that the improvements being piloted should be
limited to reduced-risk pesticides in a final rule.
B. Comment Sought on Consideration of Resistance Management Exemptions
Although not included in the limited pilot described in this
Notice, the Agency is considering another potential improvement to the
emergency exemption program, i.e., whether to allow exemptions for pest
resistance management purposes. This potential improvement was not
included in the pilot due to uncertainty and complexity of issues with
respect to the appropriate requirements for scope and degree of
resistance development, as well as level and type of documentation. To
aid the Agency in developing this potential improvement for inclusion
in the proposed rule that is currently expected in 2003, the Agency
specifically seeks comment on this additional potential improvement to
the emergency exemption program that would allow exemptions for
resistance management under specific criteria where pest resistance to
registered pesticides is developing or has developed.
1. What is our current practice? Exemptions are only authorized for
resistance management in cases where documented pest resistance to the
registered pesticide has already developed and use of the registered
pesticide is expected to result in significant economic losses. Under
current regulations, if there is at least one available registered
pesticide that is effective enough to prevent significant economic
losses, then the situation is generally not found to be an emergency
regardless of whether or not the alternative is considered to be
vulnerable to the development of resistance by the target pest.
2. How might resistance management exemptions work? Some
emergencies are the result of the development of pest resistance to a
registered pesticide that is essential for the management of a pest
which, unchecked, can cause significant economic loss. The optimal time
to respond to this emergency would be early enough to prevent or retard
the development of widespread resistance. Timely action in granting the
emergency use of another pesticide could increase
[[Page 20154]]
the useful life of the essential registered pesticide and ultimately
limit the need for more emergency exemptions. The potential improvement
would take a more preventive approach to resistance management.
Under such an approach, EPA could review applications and look for
all four of the following criteria before approving an emergency
exemption request for resistance management:
i. Pest resistance is developing or has developed to the registered
pesticide product. Claims that a pest is developing or has developed
resistance to a pesticide should be documented by scientific evidence.
The applicant would submit the best readily available information which
supports their case. Because acceptable techniques for verifying
resistance vary considerably for the numerous crop-pest-pesticide
combinations, EPA determinations on sufficiency of documentation would
be made on a case-by-case, weight-of-the-evidence basis. Resistance
development would be documented through field studies, references to
field studies, or loss of ability to control the pest in the field and
confirmed to be due to pest resistance in commercial plantings or other
actual use conditions such as in greenhouses.
Typically, documentation of a decrease in susceptibility to a
pesticide would involve collections of pest samples from fields
suspected of containing high frequencies of resistant pests, and
laboratory bioassay would be conducted to estimate the frequency of
resistant individuals and the degree of resistance. Field tests would
be conducted to assess the degree to which the laboratory resistant
bioassay reflects loss of efficacy under typical treatment conditions
in the field. Because resistance developed or measured under laboratory
or other non-field conditions may not accurately reflect conditions in
normal use situations, the applicant would need to demonstrate that the
data presented can substitute for field conditions. That is, the
laboratory bioassay must have relevance to the field such that
individuals shown to be resistant in the laboratory bioassay actually
do contribute to a substantial loss of efficacy under the treatment
conditions of the field. The data should reflect numerous
susceptibility estimates within single locations and multiple locations
to confirm resistance and account for within-field variability. The
geographic extent of resistant populations should be described.
The applicant could present evidence on previously reported
resistance incidences that are substantially similar to the pest
situation under consideration, as well as a rationale for why
resistance is anticipated. Applicable situations include those where
resistance has been documented, either in the U.S. or outside the U.S.,
for the same pest species or related pest species, similar pesticide
use patterns, and comparable climatic conditions. Documentation of
comparable situations should also include evidence that the loss of
efficacy was not due to misapplication, weather, or other effects not
due to resistance. Documented field failures due to pest resistance
outside the U.S. and/or laboratory or non-commercial greenhouse
experiments could also be included to substantiate resistance in the
same or closely related pest species. However, evidence should be
presented to justify the use of related pest species, since even
closely related pest species may have a different genetic potential to
develop resistance.
Information should be provided on the genetic, biological (biotic
and behavioral), and operational (chemical and application technology)
characteristics that influenced the selection of resistance. Evidence
should be provided that indicates the typical number and frequency of
pesticide applications, and rate of application used, and host, and why
the target pest is likely to develop or has developed resistance at the
requested and/or reported site(s), country, county, State, or region.
The applicant must also discuss what has been done to manage resistance
to the existing registered alternatives and why the requested pesticide
is essential to managing pest resistance. This information is important
for understanding the basis of resistance and choosing appropriate
strategies to manage it.
ii. The registered chemical to which resistance is developing is
considered essential for the management of the pest(s) in the
particular crop. The pesticide to which resistance is developing should
be a registered pesticide which serves as the standard treatment, is
critical for obtaining control of the emergency pest, and for which
suitable registered alternatives are lacking. If the registered
pesticide is used only rarely, the likelihood of resistance developing
is generally greatly reduced. Applicants would be asked to document
that the pest is one which occurs regularly in the subject crop and
State, and is capable of causing a significant economic loss (see Unit
V.B.) if no effective control were available. This criterion would
ensure that, while addressing resistance proactively by preventing
future emergency conditions before they occur, the scope of these
exemptions would not include those for which an actual emergency would
never occur.
iii. The request is for only one chemical, which is in a different
class, or has a different mode of action, from the registered chemical
to which resistance is developing. Applicants would be asked to provide
evidence to demonstrate that the requested chemical has a different
mode/mechanism of action, metabolic effect, behavioral response, target
enzyme, or target life stage from the available effective registered
pesticides. Evidence should also be presented regarding whether the
requested pesticide may result in unintended pesticide exposure in non-
target pests, if available. Pesticide Registration Notice 2001-5,
available in the public docket for this Notice and on the Internet at
http://www.epa.gov/opppmsd1/PR_Notices/pr2001-5.pdf, describes the
Agency's voluntary policy toward resistance management based on mode of
action. The Appendices of that document provide the mode of action
classification of all of the available registered active ingredients
for insecticides, miticides, acaricides, fungicides, bactericides, and
herbicides for agricultural uses.
iv. The applicant has a credible approach to managing the
development of resistance using both the requested chemical and the
chemical to which resistance is developing. The applicant would be
asked to include various pest management strategies to reduce selection
pressure to not only the requested pesticide, but also the registered
alternatives that still may have utility. When available, the applicant
should also include supplemental control measures for reducing
selection pressure, especially those of a non-chemical nature (e.g.,
biocontrol, scouting, cultural practices, crop rotation, and use of a
pest forecasting system). Management tactics might also include
biological and ecological factors that influence pest migration,
dispersion, or overwintering, for example. Management strategies should
consider all useful information on the stability and inheritance of
resistance (cross- and multiple resistance) and relevant information on
pest ecology, biology, and toxicology.
3. Why is this potential improvement being considered? EPA believes
that granting emergency exemptions on the basis of resistance
management is a proactive approach for addressing the development of
resistance in its early stages, thereby preventing significant economic
losses before they occur. Availability of an additional pesticide for
resistance management may reduce the likelihood of the common scenario
[[Page 20155]]
of increasing frequency and rate of application of a single available
pesticide with decreasing effectiveness. Therefore, a decrease in risk
to man and the environment is expected to accompany the economic
benefit to pesticide users.
4. Are there particular questions to consider in preparing
comments? The Agency is looking for specific comments on the types of
data or documentation to demonstrate resistance and the proposed
approach for this type of emergency exemption. In order to help focus
public comments on the resistance management proposal, the following
questions and issues are offered for consideration and comment:
i. There is likely to be some delay in confirming resistance in the
field once it is suspected.
Given this circumstance, what level of documentation would be
appropriate through laboratory, greenhouse, or field studies either in
county, State, region, inside or outside the U.S.?
ii. How should noted resistance in related pest species be used to
aid a request?
iii. How many years of field data and how many geographic locations
would one need to establish a reasonable case for pest resistance?
iv. Comments are requested on the documentation of cross-resistance
potential.
v. Should emergency exemptions for resistance management be limited
to requests for chemicals in a different class, or with a different
mode of action, than the chemical to which resistance is developing?
vi. What evidence should be provided to demonstrate the likely
effectiveness of proposed management strategies to manage resistance?
C. General Considerations for Commenters
As you prepare comments for submission to EPA, you may find the
following suggestions helpful:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the Notice or collection
activity.
7. Make sure to submit your comments by the deadline in this
Notice.
8. 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.
List of Subjects
Environmental protection, Pesticides, Emergency exemptions.
Dated: April 16, 2003.
Stephen L. Johnson,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 03-10169 Filed 4-23-03; 8:45 am]
BILLING CODE 6560-50-S
![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}