[Federal Register Volume 68, Number 79 (Thursday, April 24, 2003)]
[Notices]
[Pages 20145-20155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10169]


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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.

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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: [email protected].

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 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.epa.gov/edocket/ 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

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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 
[email protected], 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 
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

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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