Pesticides; Emergency Exemption Process Revisions, 4495-4512 [06-743]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 18 (Friday, January 27, 2006)]
[Rules and Regulations]
[Pages 4495-4512]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-743]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 166

[EPA-HQ-OPP-2004-0038; FRL-7749-3]
RIN 2070-AD36


Pesticides; Emergency Exemption Process Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This action revises the regulations governing emergency 
exemptions that allow unregistered uses of pesticides to address 
emergency pest conditions for a limited time. One change provides 
applicants for certain repeat exemptions a simple way to re-certify 
that the emergency conditions that qualified for an exemption in a 
previous year continue to exist. Another change revises the criteria 
for determining when a potential emergency condition is expected to 
cause a significant economic loss and revises the data requirements for 
documenting the loss. These revisions streamline and improve the 
application and review process by reducing the burden to both 
applicants and the Environmental Protection Agency (EPA, or ``the 
Agency''), allowing for potentially quicker decisions by the Agency, 
and providing for consistent and equitable determinations of 
``significant economic loss`` as the basis for an emergency. This 
action also includes several minor revisions to the regulations. None 
of these various improvements compromise protections for human health 
and the environment.

DATES: This final rule is effective on March 28, 2006.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2004-0038. All documents in the 
docket are listed on the www.regulations.gov web site. (EDOCKET, EPA's 
electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced federal-wide electronic docket management and 
comment system located at https://www.regulations.gov/). Follow the on-
line instructions. Although listed in the index, some information is 
not publicly available, i.e., CBI or other information whose disclosure 
is restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA, Monday 
through Friday, excluding legal holidays. The Docket telephone number 
is (703) 305-5805.

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-
0001; 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 
an emergency use authorization under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Potentially 
affected entities may include, but are not limited to:
     Federal Government (NAICS Code 9241), i.e., Federal 
Agencies that petition EPA for section 18 use authorization.
     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 in this unit 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. If you have any questions regarding the applicability of 
this action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. An electronic version of 40 CFR part 166 is available at E-
CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.

II. Purpose

    The primary purpose of this rulemaking is to simplify the process 
of applying for emergency exemptions, and allow for potentially quicker 
responses to emergency pest conditions, without affecting current 
protections for human health and the environment. This action revises 
the regulations at 40 CFR part 166, to make a variety of improvements 
to the pesticide

[[Page 4496]]

emergency exemption program and process. The two most significant of 
the revised requirements are streamlining provisions intended to reduce 
the burden to both applicants and the Agency and to expedite decisions 
on some exemption requests. The first of these revisions expressly 
authorizes applicants for certain repeat exemptions to re-certify that 
an emergency condition continues in subsequent years, and to 
incorporate by reference all information submitted in a previous 
application rather than annually re-submit complete but perhaps 
redundant applications.
    The second change revises the approach to determining when a 
potential emergency condition is expected to cause a ``significant 
economic loss'' (SEL). In addition to reducing the application and 
review burden, the new economic assessment approach will result in 
consistent and equitable determinations of whether a significant 
economic loss is expected. These two streamlining approaches have been 
tested in limited pilot projects since 2003.
    In addition, EPA is making a number of revisions to correct or 
update minor administrative aspects of the emergency exemption 
regulations. The reason for each of these minor administrative 
revisions falls into one of the following categories: Conformance with 
statutory requirements arising from the Food Quality Protection Act of 
1996 (FQPA); codification of improved practices that have been 
voluntary but widely followed by applicants; and correction of 
typographical or administrative errors. Also, the Agency is adding 
specific language to the regulations to clarify that treatment of 
``invasive species'' is a valid basis for issuing a quarantine 
exemption.

III. Statutory Authority

    EPA regulates the use of pesticides under the authority of two 
federal statutes: FIFRA and the Federal Food, Drug, and Cosmetic Act 
(FFDCA).
    FIFRA provides the basis for regulation, sale, distribution, and 
use of pesticides in the United States. FIFRA generally prohibits the 
sale and distribution of any pesticide product, unless it has been 
registered by EPA in accordance with section 3. (7 U.S.C. 136a). 
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 that require 
such an exemption. (7 U.S.C. 136p). Under section 2(aa) of FIFRA, the 
term ``State'' is defined to include a ``State, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
the Trust Territory of the Pacific Islands, and America Samoa.'' (7 
U.S.C. 136(aa)).
    Section 408 of FFDCA authorizes EPA to set maximum residue levels, 
or tolerances, for pesticides used in or on foods or animal feed, or to 
exempt a pesticide from the requirement of a tolerance, if warranted. 
(21 USC 346a). Section 408(l)(6) provides that where EPA grants an 
emergency exemption under FIFRA section 18, the Agency must establish a 
time-limited tolerance or exemption from the requirement of a tolerance 
for any residues of the pesticide chemical in food or feed.

IV. Background

A. April 2003 Notice Initiating Pilot for Two Primary Revisions now 
being Codified

    EPA published a Notice in the Federal Register on April 24, 2003 
(68 FR 20145) (FRL-7293-6), announcing the initiation of a limited 
pilot program to test two potential improvements to the emergency 
exemption process. The pilot continued through the end of 2005, but has 
not been extended for 2006 as it is superceded by this final rule. The 
two potential improvements included in the pilot were: (1) Allowing 
applicants for certain repeat exemptions to re-certify that the 
emergency condition still exists in the second and third years, and to 
incorporate by reference all information submitted in a previous 
application rather than annually re-submit to EPA complete new 
applications and, (2) a new approach to documenting an SEL that focuses 
on the significance of the potential loss relative to yields and/or 
revenues without the emergency rather than a comparison to historical 
profit variation. The April 2003 notice also discussed whether 
exemptions for the purpose of pest resistance management might be 
allowed. Finally, the notice solicited public comment on all three 
potential changes and announced EPA's plan to issue a proposed rule 
addressing them. The two revised practices included in the pilot are 
also included in this final rule, with modification. Today's final rule 
expands the application to all pesticides, beyond the restriction to 
reduced-risk pesticides under the limited terms of the pilot.
    Anyone interested in the background leading up to the pilot 
program, or other related documents, may wish to review the 
announcement of the pilot, and the related documents. EPA considers the 
comments on the pilot program to be part of the administrative record 
for this rulemaking. A public docket was established for that 
announcement under docket ID number EPA-HQ-OPP-2002-0231. Interested 
parties should follow instructions under ADDRESSES for accessing the 
docket, but should use docket ID number EPA-HQ-OPP-2002-0231 to access 
the docket for the April 24, 2003, announcement.

B. September 2004 Proposed Rule

    EPA published a proposed rule on September 3, 2004 (69 FR 53866) 
(FRL-7371-3). The proposed rule included proposals for the two revised 
practices in the pilot program, but without the limitation to reduced-
risk pesticides, as well as a number of minor administrative revisions. 
Key public comments and Agency responses are briefly summarized in Unit 
V. of this document and, more completely, in a separate Response to 
Comments document available in the public docket.
    Those interested in seeing the proposed rule, related documents, 
and public comments submitted may access them in the docket. A public 
docket was established for this rulemaking under docket ID number EPA-
HQ-OPP-2004-0038. Interested parties should follow instructions under 
ADDRESSES for accessing the docket.

C. Summary of Pilot Experience

    The pilot was started on April 24, 2003, and will not be extended 
for the 2006 growing season as it is being superceded by today's final 
rule. Applicability of the pilot was restricted to ``reduced-risk'' 
pesticides in order to limit the scope and effectively add an 
additional margin of safety while the new procedures were tested. 
Although participation in the pilot was limited, the process worked 
well for both applicants and EPA.
    For the 2003 growing season, 16 exemptions were identified by EPA 
as eligible for re-certification, of which 7 submitted re-certification 
applications. In 2004, 12 exemptions were eligible, of which 4 applied 
by re-certification, while in 2005, 10 exemptions were eligible for re-
certification and 6 used the process. EPA made expedited decisions on 
re-certification requests under the pilot in an average of 9 days in 
2003, 14 days in 2004, and 8 days in 2005, counted from receipt of the 
request until the decision was made. Of the exemptions that were 
eligible but for which no re-certification was submitted, some were for 
pesticide uses that had obtained federal registration under FIFRA 
section 3 since the previous year's exemption, some were not requested 
at all (indicating that the

[[Page 4497]]

emergency ended), and the others were requested using conventional 
exemption requests.
    The revised approach to determining an SEL applied to any new 
exemption request, as long as the requested chemical was designated as 
reduced-risk. However, for all 3 years of the pilot, EPA voluntarily 
conducted economic evaluations of exemption requests using both the 
current approach of historical 5-year data, as well as the proposed new 
loss-based (tiered) approach. This experience indicates that the new 
approach will not cause EPA to find SEL more commonly, nor expand the 
definition of emergency. A retrospective analysis to develop the loss-
based approach, covering 2000 through 2003, showed that approximately 
the same number of requests would result in an SEL finding using the 
new, loss-based approach as actually occurred under the existing 
approach. The new criteria will, in most cases, reduce applicants' data 
burden and thereby streamline the exemption process.

V. Public Comments, EPA Responses, and Modifications for Final Rule

    This unit briefly discusses the major public comments received on 
the proposed rule, EPA's responses to those comments, and changes made 
in the final rule as a result. All comments leading to modifications to 
the proposed revisions for the final rule are included here, as are 
opposing comments on the same issues, and comments opposed to proposed 
revisions for which modifications were not made. A more detailed, 
complete summary of public comments and Agency responses is available 
in a separate document in the public docket for this rule. That 
document also addresses comments and responses on the April 2003 
document that announced the pilot program.
    A total of 28 submissions of public comments on the proposed rule 
were received. A total of 41 commenters were represented by these 
comments, as some were submitted jointly by multiple parties. For ease 
of discussion and a better understanding of the sources of the various 
comments, commenters are grouped according to the type of organization 
or interest. The number of comment submissions on the proposed rule, by 
type of commenter are: Two by education/research groups; 3 by 
agriculture/food industry groups; 1 by environmental/public interest 
groups (joint submission by 13 groups); 12 by grower groups; 2 by 
pesticide industry/registrants; 1 by a private citizen; and, 10 by 
States (9 State lead pesticide regulatory agencies and 1 by the 
American Association of Pesticide Control Officials, which represents 
the States in pesticide regulatory matters).
    Generally, all except for the environmental/public interest groups 
and the private citizen favored both of the two primary proposals, 
although a few only commented on one of the two, and some suggested 
modifications. The 13 environmental/public interest groups and the 
private citizen were opposed to both of the primary revisions, but the 
environmental/public interest groups also suggested some modifications 
to the proposals.
    All changes made in the final rule relative to the proposed rule 
are explained in this unit, while a summary of all provisions of the 
final rule is in Unit VI. EPA decided to make these changes to the 
proposed revisions after considering public comments on the proposed 
rule. Each substantive comment is briefly paraphrased, followed by 
EPA's response to that comment. Where multiple commenters made a 
substantially similar comment, it is stated once, with an indication of 
how many made the comment and the types of organizations the commenters 
represent.
    This unit is organized into separate sections for the two main 
provisions of the final rule, a section on all other aspects of the 
rule, and a section on miscellaneous comments not covered in the first 
three sections. Within each section, one or more issues raised by 
commenters is addressed. For each issue, all applicable comments are 
presented, followed by EPA's response, including the resulting 
modification to the proposed revision, if any, and the rationale for 
making the change or not.

A. Re-certification of Emergency Condition by Applicants

    EPA has significantly reorganized Sec.  166.20(b)(5) for improved 
clarity, but no substantive changes relative to the proposed rule are 
intended, except as discussed below.
    1. Commenter Issue: Allow re-certification beyond third year--(a) 
Comments requesting modification to proposal. The proposed rule would 
have allowed re-certification applications only in the second and third 
years of an exemption for an applicant, assuming the exemption met the 
eligibility criteria (e.g., type of emergency condition that could 
reasonably be expected to continue). Many commenters stated that 
eligibility to use a streamlined re-certification application for 
repeat requests should not be limited to the second and third years of 
an exemption, but rather be longer or indefinite, as there is no 
compelling reason to limit it to 3 years. These commenters argued that 
re-certification is specifically and solely for the purpose of 
determining the existence of an emergency condition, and that EPA could 
still decline a valid re-certification application based on new risk 
information, availability of new alternative controls, or insufficient 
progress toward registration of the requested use.
    In addition, full registration of a pesticide product often takes 
longer than 3 years, particularly for minor uses, even when States move 
expeditiously to identify the need. The commenters felt that States and 
affected growers should not be penalized when registration actions take 
more than 3 years. Commenters who supported allowing re-certification 
beyond the third year suggested various alternative limitations, 
including no limit. These general comments were made by 22 commenters 
(9 grower groups, 7 State lead agencies, 2 education/research groups, 2 
agriculture/food industry groups, and 2 pesticide industry/
registrants).
    (b) Opposing comments. Other commenters felt that applicants should 
not be allowed to re-certify emergency conditions at all. They stated 
that repeat conditions are routine, and therefore not an emergency, as 
defined in the regulations. These commenters believe that repeat 
requests reflect poor management by growers and that repeat exemptions 
should be more difficult, not easier, to obtain. They contend that EPA 
already grants too many repeat exemptions and ignores progress-toward-
registration requirements. Allowing applicants to re-certify emergency 
conditions would only make matters worse. These comments were made by 
13 environmental/public interest groups in a joint submission, and by 
one private citizen.
    (c) EPA Response, including decision on re-certification limits. 
EPA has carefully considered the comments summarized above concerning 
whether, and how long, to allow re-certification applications. The 
Agency is convinced not only that the re-certification process will 
provide the intended benefits of reduced burden and potentially quicker 
emergency response without negative consequences, but also that it 
would afford the same benefits in subsequent years as it would in the 
second and third years. Therefore, benefits would increase with the 
greater applicability of this improved process. Any specific limit to 
the number of years of eligibility for re-certification would be 
arbitrary. Therefore, in the final rule EPA has chosen to remove the 
applicability

[[Page 4498]]

restriction for re-certification that would have limited it to the 
second and third years.
    However this modification to the proposed 40 CFR 166.20(b)(5) 
includes the authority for EPA to declare an exemption ineligible for 
re-certification at any time, on a case-by-case basis. In determining 
whether to end eligibility for re-certification, the Agency will 
consider the continued validity of the information, generally from the 
original application, that documents the projected losses, as well as 
whether any of the other information needs to be updated. If EPA 
decides that updating the documentation of an SEL is likely to 
significantly improve the projected loss estimates, or, if any other 
information casts doubt on whether the initial conditions still exist, 
then the Agency may declare the exemption ineligible for re-
certification. The applicant for any exemption that is ineligible for 
re-certification may use a standard, full application format.
    In response to comments questioning whether re-certification, or 
any repeat exemption requests, should be allowed at all, EPA has 
recognized for many years that an emergency may continue for multiple 
years when the emergency condition continues relative to the routine 
situation prior to the first occurrence of the emergency. This most 
commonly occurs when a pesticide, formerly relied upon by growers, 
becomes unavailable for use or loses effectiveness and no other 
effective means of pest control is available. Such a situation would 
generally continue until an alternative control becomes available, 
e.g., an effective alternative pesticide becomes registered for the use 
(often the chemical requested for the exemption), or an effective 
alternative non-chemical control becomes available.
    The ability to indefinitely re-certify emergency conditions is not 
expected to increase the number of exemption requests submitted or the 
number of exemptions granted. EPA expects that when an emergency 
condition continues in a subsequent year, States would submit a repeat 
application regardless of whether a streamlined or full application 
were required. This rule reduces the burden in such situations. EPA 
believes that the reduced burden afforded by this rule would not induce 
applicants to make a repeat request.
    Re-certification that an emergency condition continues to exist, 
for a previously granted exemption, would be part of a streamlined 
application for an emergency exemption. If the same emergency condition 
exists in a subsequent year that existed for the first year of an 
exemption, then EPA would generally again find that the emergency 
condition exists, regardless of whether a full application or a re-
certification application were submitted. A re-certification 
application would simply reduce the burden on the applicant and help 
the Agency make the emergency determination more quickly. However, a 
determination by EPA that an emergency condition exists is not 
sufficient basis for an exemption to be approved. A re-certification 
application is no more likely to be approved than a full application 
for the same repeat request. Like a full application, a re-
certification application would also be reviewed for, and could be 
denied owing to any of the following: New risk information; 
availability of new, effective alternative controls; or insufficient 
progress toward registration of the requested pesticide use.
    Some commenters believe EPA grants too many repeat exemptions and 
that some exemptions are repeated for too many years. EPA would like to 
limit the number and length of long-running exemptions, and is pursuing 
new opportunities for minimizing such outcomes. Each year, EPA makes 
registration decisions on a large number of pesticide uses sought 
separately by State applicants under the emergency exemption program. 
For the fiscal years 2001 through 2004, EPA transitioned 313 uses to 
federal labels that had been requested under the section 18 exemption 
program, thereby precluding further repeat exemptions for those uses. 
These products are registered after a comprehensive analysis of the 
risks posed by these uses.
    In addition, the Pesticide Registration Improvement Act (PRIA), 
enacted in early 2004, established time limits for EPA to make 
decisions on registration actions under section 3 of FIFRA which should 
further accelerate the pace of registration decision-making for all 
actions. Because of the emphasis within PRIA on review schedules, EPA 
is processing registration decisions more quickly than in the past. 
Pesticide uses that are requested for repeat exemptions will either 
gain registration more quickly than in the past, or their registration 
application could be not granted or denied in the same timeframe. The 
congressionally mandated review schedules under PRIA all become shorter 
and more compressed in upcoming years. For instance, the Agency's 
available review period for a new food use for a conventional pesticide 
goes from 38 months in FY 2004 to 22 months in FY 2006. Similarly, the 
review schedule for each type of registration action becomes shorter in 
later implementation years of the law. Although PRIA shortens the 
timeframe for registration decisions, the law also provides more 
resources through registrant fees and does not compromise the rigorous, 
comprehensive nature of the risk analysis necessary to support each 
registration decision. In this manner, EPA expects that each 
registration action will be evaluated within the context of PRIA. Under 
the previous priority planning scheme, certain actions did not receive 
priority due to resource and policy considerations. Additionally, EPA 
is mandated to complete re-registration of older pesticides by the end 
of 2006. Remaining decisions on eligibility to re-register pesticide 
products are also expected to affect repeat exemptions, leading to the 
denial of some and paving the way for the registration of others.
    The Interregional Research Project No. 4 (IR-4) program is a highly 
successful cooperative effort and partnership of the State land grant 
universities, industry, the U.S. Department of Agriculture (USDA), and 
EPA, to address the chronic shortage of pest control options for minor 
crops. In many cases, the crop protection industry lacks economic 
incentive to pursue registrations on minor crops because of low acreage 
and limited sales potential. IR-4 generates and supplies research data 
needed by EPA in order to register compounds for use on minor crops. 
The IR-4 process continues to improve, and registrations for repeat 
exemptions are among the highest priorities in the IR-4 queue. In 1999, 
IR-4 initiated a streamlined project schedule of 30 months for its 
highest priority clearance projects. Pest management gaps associated 
with section 18 applications qualify for this highest priority schedule 
of 30 months. IR-4 is also increasingly performing research on 
pesticides which are presumed to pose less hazard than traditional 
synthetic chemicals. Over three quarters of the pesticides IR-4 
evaluates and then submits for review to EPA are classified as reduced-
risk materials under the Agency's programs for supporting transition to 
lower toxicity and sustainable means of pest management. Additionally, 
the review schedule under PRIA also favors and places a bias in support 
of submissions involving reduced-risk pesticides. For instance, the 
Agency's review time period under PRIA for a new use of a conventional 
pesticide in FY 2006 is 22 months whereas the review period for a 
reduced-risk pesticide in FY 2006 is 20 months. These incentives could 
help IR-4 and its collaborators realize a large

[[Page 4499]]

number of clearances. EPA anticipates that the processes discussed 
above will further enhance recent successes in registering repeat uses 
faster, as well as ensure that regulatory evaluations for any pending 
registration actions associated with a section 18 use will take place 
efficiently.
    EPA has authority under Sec.  166.32 to revoke any exemption during 
its active use period, if the Agency learns that the emergency no 
longer exists, the risks are unacceptable, the use is not effective, or 
users are not complying with the terms and conditions of the exemption. 
When necessary and appropriate, this provides another means to end 
long-running exemptions quickly, without waiting for an exemption to 
expire.
    2. Commenter Issue: Make voluntarily canceled pesticides ineligible 
for re-certification--(a) Comments requesting modification to proposal. 
Some commenters felt that voluntarily canceled pesticides should be 
added to the list of pesticide categories for which, when requested for 
an exemption, the applicant is not eligible to use a re-certification 
application. The proposal already lists several categories of 
pesticides (e.g., new active ingredient, first food use, canceled 
pesticides) that warrant heightened review and public notice, and are 
therefore not eligible for re-certification. These commenters contended 
that EPA should not allow re-certification for voluntarily canceled 
pesticides. This comment was made by 13 environmental/public interest 
groups in a joint submission.
    (b) Opposing comments. No other comments were received on the issue 
of pesticide categories ineligible for re-certification.
    (c) EPA Response, including decision on modification. The proposed 
rule listed several categories of pesticides as ineligible for re-
certification. Specifically, the existing regulations at 40 CFR 
166.24(a) identify a number of situations where, upon receipt of an 
application for an emergency exemption, the regulatory status of a 
pesticide product calls for public notice and comment. EPA believes 
there is a legitimate need for heightened review and awareness of 
exemption requests with the listed regulatory statuses. Both the 
notice-and-comment requirements as well as the need for heightened 
review would preclude the benefit of an expedited review that would 
otherwise be expected from a re-certification application. The 
categories proposed as ineligible for re-certification include new 
pesticide active ingredients, first food uses, canceled or suspended 
pesticides, and pesticides that have been the subject of a Special 
Review. Because a pesticide that has been voluntarily canceled by its 
registrant may be similar to these other categories of pesticides, the 
Agency agrees with this comment and believes this category of pesticide 
uses should also be ineligible for re-certification. Therefore, the 
proposed 40 CFR 166.20(b)(5) is modified accordingly in the final rule. 
Also, EPA is expanding the provision for 40 CFR 166.24 to add this 
category of pesticide uses to those for which EPA will issue a Notice 
of Receipt. Therefore, a Notice of Receipt will be published in 
connection with the submission of emergency exemption uses that involve 
pesticide uses which have been voluntarily canceled. Therefore, while 
applicants may still request exemptions for a voluntarily canceled 
pesticide, the streamlined re-certification application process will 
not be allowed for such uses.
    3. Commenter Issue: Add to documentation requirements for repeat 
exemptions--(a) Comments requesting modification to proposal. Some 
commenters suggested that repeat applicants should be required to 
document at least:
    (i) What effect the exemption had on the emergency condition during 
the first year,
    (ii) Why the exemption continues to be necessary,
    (iii) That there are no feasible non-chemical alternatives, and,
    (iv) That the original predictions of economic harm are legitimate. 
This comment was made by 13 environmental/public interest groups in a 
joint submission.
    (b) Opposing comments. No other comments were received on the issue 
of modifying the documentation requirements for repeat exemption 
requests.
    (c) EPA Response, including decision on modification. EPA's 
responses below correspond to the lettered list of the commenters' 
suggested documentation requirements for repeat requests:
    (i) Annually, in a post-exemption report per Sec.  166.32, and with 
any repeat application per Sec.  166.20(a)(11), applicants will still 
be required to include a description of the effect the exemption had on 
the emergency condition.
    (ii) A re-certification application must contain a certification 
that the same emergency condition previously documented continues and 
is the reason the exemption continues to be necessary.
    (iii) EPA believes that the applicant is in a better position than 
the Agency to identify availability of a non-chemical alternative, 
i.e., cultural practice, for the specific use in their State. EPA 
agrees that it would be appropriate to have applicants (which are 
primarily State agencies) for repeat exemptions document availability 
and effectiveness of new non-chemical controls identified since the 
previous year's application, or to certify that none are known. 
Therefore, in the final rule EPA has added a requirement, at Sec.  
166.20(b)(5)(v)(E), that applicants certify that they are not aware of 
any alternative non-chemical practice that may offer a meaningful level 
of pest control, or else provide documentation that each such known 
practice does not provide adequate control or is not economically or 
environmentally feasible. In situations where such effective and 
feasible cultural practices are available, EPA would not grant the 
exemption because there would not be an emergency condition, by 
definition.
    (iv) One way to validate the reasonableness of the estimated losses 
would be to allow them to happen, i.e., to grow the crop under the 
emergency condition without use of the requested pesticide. EPA already 
has the discretion to grant a repeat exemption subject to the condition 
that some research areas be grown under the emergency condition without 
use of the requested pesticide, although such validation has generally 
not been required. Occasionally, confirmatory data, such as comparative 
product performance studies, are required on repeat requests. The re-
certification program would not alter this practice. Furthermore, re-
certification requires that other economic factors that result in a 
projection of an SEL (e.g. cost of alternative, crop prices) have not 
changed substantially, and that there is no new information about pest 
damage.

B. Determining and Documenting ``Significant Economic Loss'' (SEL)

    1. Commenter Issue: Lower quantitative thresholds for SEL, add 
flexibility--(a) Comments requesting modification to proposal. Some 
commenters said that the thresholds for the three tiers for determining 
SEL should be lower, as the proposed thresholds require total 
elimination of net income to qualify. Also, EPA should be allowed 
flexibility to use judgement to make an SEL finding for situations not 
meeting any of the thresholds. Commenters argued that total elimination 
of annual net income is too severe a threshold, and that some lesser 
loss constitutes a significant economic loss. These commenters feel the 
three tiers should be screens to identify obvious emergencies, and that 
flexibility, which does not clearly exist

[[Page 4500]]

in the proposed rule, should be added to identify the less obvious 
emergencies. No commenter suggested an alternative level for any 
threshold, or a basis on which to develop one. This general comment was 
made by 17 commenters (9 grower groups, 4 State lead agencies, 2 
agriculture/food industry groups, and 2 pesticide industry/
registrants).
    (b) Opposing comments. Other commenters felt that the proposed 
quantitative thresholds for determining SEL are already too low. They 
stated that the proposed tiered approach to document an SEL with the 
selected thresholds would unreasonably expand the definition of 
emergency and make it easier to find that an emergency exists. These 
commenters felt that the proposed method allows prohibited pesticide 
uses for profit. They assert that the proposed new approach together 
with the quantitative thresholds for the three tiers are unlawful, 
arbitrary and capricious, and contrary to congressional intent. This 
comment was made by 13 environmental/public interest groups in a joint 
submission.
    (c) EPA Response, including decision on modification. After 
considering all comments, EPA believes that the proposed thresholds are 
appropriate and should not be relaxed, but that flexibility should be 
available to allow EPA to use judgement to make an SEL finding where 
projected losses are particularly difficult to quantify or other 
factors warrant an emergency exemption. Some commenters concluded that 
the proposal provided no flexibility for EPA to use judgement to 
determine an SEL for situations not meeting any threshold, regardless 
of how close to a threshold quantitative loss projections may come. To 
the extent that this comment reflects a concern that EPA would consider 
only quantitative data in determining whether the loss thresholds are 
met, EPA notes that it interprets the language of both the proposed and 
final rule to allow for consideration of estimates based on qualitative 
information, either alone or in addition to quantitative information, 
in determining whether losses under the emergency condition would 
exceed the thresholds for SEL. However, EPA intends to limit the use of 
qualitative information to document projected losses, relying on such 
information only in cases where credible quantitative information is 
not available.
    In response to the concern that the quantitative loss thresholds of 
Sec.  166.3(h)(1) may not apply to all pest activity primarily 
affecting the current growing season, EPA has expanded Sec.  
166.3(h)(2) so that EPA may use its broader criteria wherever they are 
more appropriate. The proposed rule provided a loss-based approach with 
quantitative thresholds applicable to pest activity primarily affecting 
the current growing season under Sec.  166.3(h)(1), and ``for all other 
pest activity'' included in a provision at Sec.  166.3(h)(2) to 
determine an SEL for situations where the loss-based approach does not 
adequately address the expected loss, similar to a provision in the 
existing regulations. Such losses include those not confined to the 
current year or those that impact capital assets rather than productive 
activities. This change to Sec.  166.3(h)(2) will allow the flexibility 
to apply an appropriate methodology for assessing the consequences of 
an emergency, and help ensure that any of the widely variable 
situations potentially causing an SEL can be adequately addressed.
    Although no commenter addressed the issue, EPA has corrected the 
scope of the proposed SEL definition. The SEL criteria under the 
proposed Sec.  166.3(h)(1) would have applied to ``pest activity that 
primarily affects the current crop.'' For the final rule ``or other 
output'' is added after ``current crop,'' so that non-crop productive 
activities (e.g., dairy production) may also be assessed under the 
loss-based, tiered approach. For the same reason, EPA has removed the 
word ``crop'' from Sec. Sec.  166.3(h)(1)(i) and 166.20(b)(4)(i).
    As explained above, some commenters believe that the proposed 
thresholds for SEL are too high, arguing that these thresholds 
effectively require total elimination of net income to qualify. Other 
commenters believe that the proposed thresholds make it easier to find 
that an emergency exists, allowing unregistered pesticide uses for 
profit. Actually, the selected thresholds neither raise nor lower the 
standard for SEL. EPA's retrospective analysis of past exemption 
requests, discussed in the Economic Analysis available in the public 
docket for this final rule, shows that the new approach would not make 
SEL findings any more common and would not otherwise expand the 
definition of emergency. The analysis indicates that virtually the same 
number of requests would result in an SEL finding using the new 
approach as actually occurred under the current approach, although 
different findings (in both directions) may occur in some individual 
cases.
    Although the new tiered approach for determining SEL maintains the 
same overall standard to qualify, its fixed, quantitative thresholds 
intentionally make the standard consistent, in contrast to the current 
variable standard. However, the fixed SEL standard allows an easy 
comparison of the quantitative thresholds to farm income statistics. It 
is true that, according to USDA statistics, the new thresholds for SEL 
are roughly equivalent to elimination of net farm income from the 
affected crop, if fixed costs are also considered. Because the new SEL 
standard is comparable to the average of the current standard, for the 
first time it is apparent that the current standard is approximately 
equivalent to elimination of net farm income. However, when the States 
recommended revising the approach to determining SEL, their stated 
reason was to establish a fixed standard that is more equitable and 
easier to document. EPA had extensive interaction with stakeholders 
during the development of this rule, but received no input saying that 
the existing standard for SEL was too high.
    EPA acknowledges that economic terms such as ``net revenue'' and 
``net farm income'' may be confusing and are not always used the same 
way by all parties. Although the proposed threshold for the third tier 
for SEL is 50% of ``net revenues,'' as defined in the preamble to the 
proposed rule, this is not equivalent to ``profits'' because it does 
not include fixed costs. For the purpose of this rule, EPA defines net 
revenue as gross revenue less variable operating costs. A calculation 
of ``profit'' would typically subtract fixed costs from this amount. In 
this case, ``profit'' is roughly equivalent to the gross pay of a 
typical salaried employee and is essentially the return to the farmer's 
labor and managerial skills. This is also referred to as ``net farm 
income.'' If typical fixed costs were included in the consideration of 
impacts on income, a loss of 50% of net revenues (Tier 3 threshold) 
would, according to USDA statistics, result in approximate elimination 
of net farm income. With this as the context for the SEL thresholds, 
EPA believes that there is no basis for concern that farmers might 
unduly profit from emergency exemptions.
    Section 18 of FIFRA provides broad discretion for EPA to define and 
determine, by regulation, when an emergency exists. The Agency believes 
that the new approach and thresholds are not arbitrary or capricious, 
as they are essentially refinements to make the standard that has been 
used for years more uniform and equitable, without raising or lowering 
it. Furthermore, while this standard may seem severe to some, the 
standard for SEL was always intended to identify and avert true 
economic emergencies, and was not intended to maintain farm income at 
or

[[Page 4501]]

near a certain level. EPA believes that there should be a high standard 
for allowing an exemption from the requirements of registration. Even 
if EPA were to consider a lower standard, the Agency is not aware of a 
basis for selecting a lower standard that would not be arbitrary.

C. Other Regulatory Provisions

    1. Commenter Issue: Confirm efficacy and economics of non-chemical 
alternatives--(a) Comments requesting modification to proposal. 
Commenters stated that EPA should use section 18 to promote Integrated 
Pest Management (IPM) by confirming the efficacy and economics of non-
chemical alternatives for pesticide uses requested for an emergency 
exemption. This comment was made by 13 environmental/public interest 
groups in a joint submission.
    (b) Opposing comments. No other comments were received on this 
issue.
    (c) EPA Response, including decision on modification. The existing 
Sec.  166.20(a)(4)(ii) already requires applicants to explain why 
alternative practices would not provide adequate control or would not 
be economically or environmentally feasible. Some time after this final 
rule is issued, EPA plans to provide new guidance for applicants to 
improve the quality and consistency of information submitted on non-
chemical alternatives. Although EPA supports and encourages IPM and use 
of risk-reducing, alternative, non-chemical controls, as evidenced by 
the Agency's voluntary Pesticide Environmental Stewardship Program, the 
Agency does not directly regulate cultural practices. For this reason 
and because applicants are typically State agricultural agencies, EPA 
believes that the applicant is in a better position than the Agency to 
identify availability of a non-chemical alternative practice for the 
specific use in their State, and to assess its effectiveness and 
feasibility. In this final rule, a new provision has been added at 
Sec.  166.20(b)(5)(v)(E) to require that applicants using the re-
certification process separately certify that they are not aware of any 
available chemical alternatives or reasonable non-chemical alternative 
practices, or if they know of any such practice that they include with 
the application documentation demonstrating that the chemical or 
practice does not provide adequate control or is not economically or 
environmentally feasible.
    2. Commenter Issue: Clarify or improve notification/confirmation 
for crisis exemptions--(a) Comments requesting modification to 
proposal. Commenters stated that for crisis exemptions, the proposal to 
have applicants notify EPA and receive verbal confirmation from the 
Agency of no risk-based objections before using the crisis provisions 
needs clarification and possible revision. The proposal says that EPA 
will attempt to provide such confirmation as quickly as possible, and 
within 36 hours. Commenters stated that they may not be able to reach 
the appropriate EPA contact on a Friday, a weekend, or a holiday, which 
could delay confirmation and use of the crisis exemption until 36 hours 
after the beginning of the next work day. They suggest that EPA make 
someone available at all times, or, add a provision that notification 
can be made by voicemail, and a consent by default would be assumed 
after 36 hours if the applicant has not heard back from EPA by that 
time. One commenter also suggested that EPA should make exceptions to 
the 36-hour waiting period for EPA confirmation for some uses, 
including public health crises, bioterrorism attacks, and non-food 
uses. This comment was made by two State lead agencies.
    (b) Opposing comments. No other comments were received on this 
issue.
    (c) EPA Response, including decision on modification. The reason 
for this revision is to replace the current ambiguous language at 40 
CFR 166.43(a), which allows for the possibility of a State or federal 
agency notifying EPA after beginning use of the crisis provisions. The 
revision will codify a process that has been widely practiced and 
accepted by applicants, and that has become more necessary after 
enactment of FQPA. FQPA expressly required that time-limited tolerances 
be established for emergency exemption uses that may result in residues 
in food. EPA maintains that it is in the best interest of all parties 
(including States, EPA, users of pesticides under section 18, the food 
processing and marketing industries, etc.) that there is some assurance 
before the use begins that EPA will be able to establish a ``safe'' 
tolerance for a pesticide to be used under a crisis exemption. Without 
that assurance, users run the risk of producing an adulterated crop 
that results in unsafe pesticide residues and would be illegal to sell. 
It is also important that EPA be given the opportunity to voice other 
objections to a use being considered for a crisis exemption. The Agency 
may be aware of risk issues unknown to the applicant, and has the 
authority to deny crisis provisions for a particular pesticide use, 
under Sec.  166.41(a).
    EPA is keenly aware of the time-sensitivity of emergency situations 
for which crisis exemptions are needed. The Agency will continue to 
make every effort to receive and quickly respond to notifications of 
intent to declare a crisis. EPA believes that the concerns raised by 
these commenters can be adequately addressed in the same manner that 
EPA has managed these issues since enactment of FQPA. It is true that 
EPA staff are not available at all times, such as at night or during 
weekends, to receive notification of a State's intent to declare a 
crisis. However, EPA believes that applicants generally first become 
aware of the need for a crisis exemption at least a few days before 
notifying EPA of its intent to issue a crisis exemption. If an 
applicant notifies the Agency of their intent to declare a crisis as 
soon as possible, even before they have gathered all of the necessary 
information, EPA should be able to provide confirmation before use of 
the pesticide is needed. The Agency believes that the existing 
confirmation process now being codified has not caused significant 
delays to use of crisis exemptions in the past. In fact, there have 
been cases where EPA staff have worked with applicants during weekends 
in order to provide timely confirmation, and in extraordinary 
circumstances EPA will continue to do this in the future. A default 
presumption of no EPA objection to a crisis exemption, in cases when 
the Agency cannot be immediately reached, would provide neither the 
necessary assurances for users of the pesticide, nor proper protections 
for human health and the environment.
    EPA is not taking the commenter's suggestion that an exception to 
the need for EPA confirmation be made in cases of non-food uses, or 
public health or bioterrorism threats. For non-food uses, EPA can 
generally provide confirmation more quickly than for food uses, but 
must still be allowed the opportunity to identify other unacceptable 
risks. In the case of major public health threats or bioterrorism, a 
national emergency network and system is in place that will enable 
applicants to contact EPA at any time, and EPA will quickly respond. 
Through the National Infrastructure Protection Plan, as part of a 
network of federal, State, and local governments, agencies can quickly 
contact EPA whenever a public health threat arises, including 
terrorism. In such cases, the Agency expects to be able to act very 
quickly and at any time. For certain listed biological threats, there 
is an expedited process in place whereby, once notified of the 
emergency need for an unregistered pesticide or use, EPA would evaluate 
the applicant's remedial action plan and, after considering the

[[Page 4502]]

safety and efficacy of such use, would decide whether to issue a crisis 
decision.
    The Agency has modified the proposed language at Sec.  166.43(a) 
for the final rule, to remove references to EPA's confirmation and the 
36-hour time period, as it is not appropriate in this paragraph for 
notification by applicants to EPA. EPA will strive to provide the 
confirmation as quickly as possible and within the customary 36 hours, 
and will attempt to match the urgency of decision-making with the 
urgency of the situation. This final rule does not attempt to change 
the timeframe in which EPA provides confirmation. The Agency's practice 
will continue that the 36-hour clock does not start until EPA actually 
receives and acknowledges the notice, and only applies to business 
days. The lack of a response in 36 hours should not be interpreted as 
approval of the crisis exemption; this final rule does not include 
decision by default. The language in the proposed Sec.  166.40(c) is 
modified for this final rule to allow EPA to withhold confirmation due 
to any objection, not just risk-based objections.

D. Miscellaneous Comments

    Protections for endangered species under the emergency exemption 
program and pest resistance management issues are discussed in Unit 
VIII. These are important issues that were discussed in the preamble to 
the proposed rule, but for which no regulatory revisions were proposed. 
Some comments received on these issues are addressed in Unit VIII, 
while other significant miscellaneous comments are included below.
    1. Commenter Issue: The section 18 pilot violates the 
Administrative Procedure Act--(a) Comment summary. Commenters stated 
that the section 18 pilot violates the Administrative Procedure Act 
(APA) as a binding regulation without notice and comment. These 
commenters went on to say that EPA solicited public comment on the 
pilot provisions in the Federal Register Notice that initiated the 
pilot, but failed to respond to those comments. This comment was made 
by 13 environmental/public interest groups in a joint submission.
    (b) Opposing comments. No other comments were received on this 
issue.
    (c) EPA Response. The comment that the pilot violated the APA is 
not relevant to the proposed or final rule and to whatever extent it 
might have been relevant to the pilot program, the issue is moot 
because EPA has ended the pilot program. EPA disagrees with the comment 
because the section 18 pilot program was not a binding regulation and 
did not require notice and comment rulemaking under section 553 of the 
APA. EPA believes that participants in the section 18 pilot program 
conformed to the requirements of the Agency's existing regulations 
pertaining to emergency exemption requests at 40 CFR part 166. The 
purpose of the pilot was to gain experience and gather information for 
the rulemaking on improvements to the section 18 process. The pilot was 
intentionally limited in scope. During the course of the pilot, less 
than 5% of all applications received were eligible for the pilot and 
utilized its provisions. No applicant was required to use the pilot. 
EPA is confident that the pilot's standard for an emergency finding was 
no higher or lower than the current standard. The risk side of the 
assessment and decision process was not changed for the pilot. 
Furthermore, an additional safety margin was essentially added to the 
pilot by limiting application to ``reduced-risk'' pesticides.
    During development of the proposed rule, EPA carefully considered 
public comments received on the Federal Register Notice that initiated 
the pilot. Those comments and EPA responses are summarized in the 
separate response-to-comments document that also addressed comments on 
the proposed rule and is available in the public docket.
    2. Commenter Issue: Documentation for endangered species needs 
clarification--(a) Comment summary. Commenters stated that 
documentation requirements for endangered species concerns in emergency 
exemption requests need clarification and further guidance. They also 
said that EPA, the U.S. Fish and Wildlife Service and the National 
Marine Fisheries Service have data on endangered species that States do 
not have, and these federal agencies should either provide such data, 
or make it readily available to States. One commenter suggested that 
when measures are necessary to protect endangered species, EPA should 
involve the State early (before decision). This comment was made by 
three State lead agencies and by AAPCO.
    (b) Opposing comments. No other comments were received on this 
issue.
    (c) EPA Response: EPA believes that an important aspect of assuring 
protections of endangered and threatened species in the implementation 
of the emergency exemption program is to have available good 
information on the potential exposure and risk of a requested use to a 
listed species and its habitat. Some time after promulgation of this 
final rule, EPA plans to issue improved guidance on what information 
regarding threatened and endangered species should be included with an 
application. EPA will continue to involve applicants in the discussion 
of possible mitigation measures whenever it appears that threatened or 
endangered species may be at risk.

VI. Final Rule Revisions to Emergency Exemption Process

    While Unit V. summarizes changes in the regulatory provisions of 
the final rule from those in the proposed rule, Unit VI. summarizes how 
this final rule revises the existing regulations at 40 CFR part 166 
that govern the emergency exemption process.

A. Re-certification of Emergency Condition by Applicants

    1. How the re-certification process will work. This final rule adds 
a new paragraph (b)(5) to 40 CFR 166.20 that allows applicants for 
eligible repeat exemptions to submit streamlined ``re-certification'' 
applications. The re-certification application process applies only to 
specific exemptions, and is not available to applicants for quarantine 
exemptions, public health exemptions, or crisis exemptions. In 
addition, re-certification can only be used if the same exemption was 
approved for the same applicant the previous year, or use period, and 
meets other eligibility criteria discussed below. Subject to 
limitations specified in Sec.  166.20(b)(5) and discussed below, where 
an emergency condition that originally qualified for an emergency 
exemption continues in a subsequent year, eligible applicants may re-
certify that the same emergency condition continues and rely on the 
preceding year's submission to document the economic impact of the pest 
emergency. This re-certification approach allows applicants to 
incorporate by reference all information submitted in a previous 
application, instead of submitting a complete new application and 
supporting documentation. The re-certification of the emergency 
condition by the applicant combined with other information available to 
EPA will serve as the basis for EPA's determination as to whether an 
emergency condition continues to exist.
    While a re-certification application may allow for speedier 
preparation of exemption requests and quicker determinations by EPA 
that an emergency condition exists, it will not result in automatic 
granting of an emergency exemption. In addition to an emergency 
finding, before granting an exemption EPA must also determine that, 
among other things, there are no

[[Page 4503]]

effective registered alternatives to the requested pesticide use, no 
feasible alternative practices that provide adequate control are 
available, the requested pesticide use will not cause unreasonable 
adverse effects on human health or the environment, and there has been 
sufficient progress towards registration of the requested use. If an 
effective product has been registered for the requested use since the 
previous exemption was approved, an emergency condition may no longer 
exist. If the Agency has received new risk information since approving 
the previous exemption, then the risk will be re-evaluated. Likewise, 
if the request includes any change in the conditions of use that may 
increase exposure, such as application rate, number of applications, 
type of application, pre-harvest interval, re-entry interval, total 
number of acres, or change in the geographic area proposed for 
treatment, then the risk will also be re-evaluated. EPA may determine 
that sufficient progress towards registration has not been made for a 
requested pesticide use. The risk evaluation process for repeat 
requests is not changed by this rule.
    Not all repeat exemption requests will be eligible for re-
certification. Upon approval of any specific exemption, EPA intends to 
make an initial assessment regarding potential eligibility for a 
streamlined re-certification application the following year, in the 
event that the applicant reapplies the next year. EPA will consider the 
following in determining potential eligibility to use a streamlined re-
certification application:
    1. Whether the emergency situation could reasonably be expected to 
continue for longer than 1 year. An emergency situation could 
reasonably be expected to continue where, for example, a registered 
product relied upon by growers becomes permanently unavailable, a pest 
expands its range, or a registered product ceases to be effective 
against a pest. Situations that would not be expected to continue, and 
therefore not be eligible for re-certification, would include a 
temporary supply problem of a registered product, an isolated weather 
event, or a sporadic pest outbreak.
    2. Whether the pesticide product, owing to its regulatory status, 
warrants heightened review before any additional use is approved. EPA 
will rely primarily on the same criteria used in the existing 
regulations at 40 CFR 166.24(a), which identifies a number of different 
situations where, upon receipt of an application for an emergency 
exemption, the regulatory status of a pesticide product calls for 
public notice and comment. The first five categories listed below are 
from the existing 40 CFR 166.24(a), while the sixth is a similar 
category, added for the final rule, as discussed in Unit V.A.2. An 
applicant will be ineligible to use a re-certification application when 
the following categories of pesticides are requested for an exemption:
    (a) A new chemical;
    (b) The first food use of an active ingredient;
    (c) Any use of a pesticide if the pesticide has been subject to a 
suspension notice under section 6(c) of the Act;
    (d) A pesticide which:
    (i) Was the subject of a notice under section 6(b) of the Act and 
was subsequently canceled, and
    (ii) Is intended for a use that poses a risk similar to the risk 
posed by any use of the pesticide which was the subject of the notice 
under section 6(b);
    (e) A pesticide which:
    (i) Contains an active ingredient which is or has been the subject 
of a Special Review, and
    (ii) Is intended for a use that could pose a risk similar to the 
risk posed by any use of the pesticide which is or has been the subject 
of the Special Review;
    (f) A pesticide which:
    (i) Contains an active ingredient which was contained in a 
pesticide product that was voluntarily canceled by its registrant, and
    (ii) Is intended for a use that could pose a risk similar to the 
risk posed by any use of the pesticide which was voluntarily canceled 
by its registrant.
    Furthermore, EPA may declare that an exemption that was previously 
eligible for re-certification is no longer eligible. In determining 
whether to end eligibility for re-certification, the Agency will 
consider the continued validity of the information, generally from the 
original application, that documents the projected losses, as well as 
whether any of the other information needs to be updated. If EPA 
decides that updating the documentation of an SEL is likely to 
significantly improve the projected loss estimates, or, if any other 
information casts doubt on whether the initial conditions still exist, 
then the Agency may declare the exemption ineligible for re-
certification. The applicant for any exemption that is ineligible for 
re-certification may use a standard application.
    In instances where EPA determines that an exemption is potentially 
eligible for re-certification, EPA will advise the successful applicant 
that, should it reapply the following year, they appear eligible to use 
a re-certification application. EPA anticipates that this advice will 
be included in the notice of approval of the current year's 
application. However, if an exemption is not classified as a candidate 
for re-certification in the approval notice, and an applicant believes 
that subsequent information would make it eligible, the applicant may 
contact the Agency to request an eligibility determination. In some 
instances, EPA may determine that an emergency condition exists, and 
that the exemption appears eligible for a re-certification application 
the following year, yet conclude that additional information should be 
gathered in order to support approval in future years. In such 
instances, EPA may indicate in the approval notice that the exemption 
appears eligible for re-certification provided the applicant submits 
the specified information. Finally, EPA reserves the authority to 
declare an emergency exemption ineligible for re-certification where, 
in the Agency's sole discretion, it determines that a complete 
application is necessary.
    An acceptable re-certification application must include not only 
the applicant's re-certification that the emergency condition 
continues, but also its certification to several other specific facts, 
or be accompa