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Pesticides; Emergency Exemption Process Revisions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 3, 2004 (Volume 69, Number 171)]
[Proposed Rules]
[Page 53866-53879]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se04-30]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 166
[OPP-2004-0038; FRL-7371-3]
RIN 2070-AD36
Pesticides; Emergency Exemption Process Revisions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing several revisions to its regulations
governing emergency exemptions that allow unregistered uses of
pesticides to address emergency pest conditions for a limited time. The
first significant change would allow applicants for certain repeat
exemptions a simple way to re-certify that the emergency conditions
that initially qualified for an exemption continue to exist in the
second and third years. The second significant proposal would re-define
significant economic loss and adjust the data requirements for
documenting the loss. These proposed revisions would streamline and
improve the application and review process by reducing the burden to
both applicants and the EPA, allowing for quicker decisions by the
Agency, and providing for more consistently equitable determinations of
``significant economic loss'' as the basis for an emergency. These two
proposals are currently being employed in limited pilot programs. In
addition, EPA is proposing several minor revisions to the regulations
to clarify that quarantine exemptions may be used for control of
invasive species, and to update or revise certain administrative
aspects of the regulations. All of these proposed revisions can be
accomplished without compromising protections for human health and the
environment.
DATES: Comments must be received on or before November 2, 2004.
ADDRESSES: Submit your comments, identified by docket ID number OPP-
2004-0038, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
Agency Web Site: http://www.regulations.gov/. EDOCKET, EPA's
electronic public docket and comment system, is EPA's preferred method
for receiving comments. Follow the on-line instructions for submitting
comments.
E-mail: opp-docket@epa.gov.
Mail: Public Information and Records Integrity Branch (PIRIB)
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: Public Information and Records Integrity Branch
(PIRIB), Office of Pesticide Programs (OPP), Environmental Protection
Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington,
VA. Such deliveries are only accepted during the Docket's normal hours
of operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to docket ID number OPP-2004-
0038. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.epa.gov/edocket, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the federal
regulations.gov websites are ``anonymous access'' systems, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through EDOCKET or regulations.gov, your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit EDOCKET on-line or see the
Federal Register of May 31, 2002 (67 FR 38102) (FRL-7181-7). For
additional instructions on submitting comments, go to Unit I.C. of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.regulations.gov/. 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. 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.
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). Regulated
categories and 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
[[Page 53867]]
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 proposed
rule. 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 (http://www.regulations.gov/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR
part 166 is available at E-CFR Beta Site Two at
http://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, 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 claimed as CBI. In addition to one
complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date, and
page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Purpose
The primary purpose of this notice of proposed rulemaking is to
simplify the process of applying for emergency exemptions, and allow
for quicker responses to emergency pest conditions, without affecting
current protections for human health and the environment. This document
proposes several revisions to the regulations at 40 CFR part 166, in an
effort to make a variety of improvements to the pesticide emergency
exemption program and process. The two most significant of the revised
practices being proposed are streamlining provisions intended to reduce
the burden to both applicants and the Agency, and expedite decisions on
exemption requests. The first of these revisions would expressly
authorize applicants for certain repeat exemptions to re-certify that
an emergency condition continues in the second and third years, and to
incorporate by reference all information submitted in a previous
application rather than annually submit complete applications. The
second revision would pertain to the determination of ``significant
economic loss,'' shifting the emphasis from the historical profit
variability to the potential loss relative to yields and/or revenues
without the emergency, and establishing a tiered analysis that will in
many cases substantially reduce applicants' data burden related to
substantiating the significance of losses. Each of these revisions
would streamline the application and review process for emergency
exemptions. In addition, the proposed economic assessment approach
would directly result in more consistently equitable determinations of
whether a significant economic loss is expected than does the current
approach. These two streamlining proposals are currently being employed
in limited pilot projects.
EPA also intends to achieve several other objectives in this
proposed rule. First, revisions are proposed to correct or update
several minor administrative aspects of the emergency exemption
regulations, which have not been revised since 1986. The reason for
each of these minor administrative revisions falls into one of the
following categories: Correction of typographical or administrative
errors; conformance with requirements of the Food Quality Protection
Act of 1996 (FQPA); and codification of improved practices that have
been voluntarily but widely followed by applicants. Second, the Agency
is proposing to add specific language to the regulations to clarify
that treatment of ``invasive species'' is a valid basis for issuing a
quarantine exemption. Third, this proposed rule includes a discussion
of how the Agency protects endangered and threatened species, and
ensures compliance with the Endangered Species Act, through its
implementation of the emergency exemption program. No regulatory
proposals are included relative to endangered species measures.
Finally, this proposed rule informs the public that EPA has revised its
tentative plan to include in this proposed rule a proposal to allow
exemptions for the purpose of pest resistance management. An
explanation of why resistance management exemptions are not being
proposed at this time, and a discussion of what alternative plans the
Agency has for addressing resistance management, are included.
The Agency encourages interested parties to submit comments on any
of the proposed regulatory revisions by following the instructions
under ADDRESSES. Commenters should explain any modifications they
suggest for the proposed revisions, along with their rationale. EPA
would like applicants for emergency exemptions to submit comments
concerning their experience with the pilot for the two streamlining
provisions being proposed. Applicants who have participated in the
pilot are asked to submit comments explaining the pros and cons of the
revised practices. Applicants who were eligible for, but elected not to
participate in, the pilot are asked to submit comments explaining why
they did not participate. Units V. and VI. outline the specific
revisions being proposed, but also include discussion asking potential
commenters to consider alternative approaches for particular aspects of
the proposal. In addition to inviting public comments on this proposed
rule, EPA plans to consult the Pesticide Program Dialogue Committee
(PPDC) on these proposed revisions, as it has prior to initiating the
pilot for the streamlining proposals. Input from the public comments
received in response to this proposed rule, and experience from the
pilot will be carefully considered, when deciding whether to modify
these proposed revisions for the final rule.
[[Page 53868]]
III. Statutory and Regulatory Framework
A. Statutory Authority
EPA regulates the use of pesticides under the authority of two
federal statutes: the Federal Insecticide, Fungicide, and Rodenticide
Act (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 which 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 U.S.C. 346a).
B. Existing Regulatory Provisions
Regulations governing FIFRA section 18 emergency exemptions are
codified in 40 CFR part 166. Generally, these regulations set forth
information requirements, procedures, and standards for EPA's approval
or denial of a request from a Federal or State agency for an exemption
to allow a use of a pesticide that is not registered when such use is
necessary to alleviate an emergency condition.
Federal and State agencies may apply for an emergency exemption due
to a public health emergency, a quarantine emergency, or a ``specific''
emergency. Most emergency exemptions requested or approved fall under
the category of ``specific exemptions'' and are requested in order to
avert an economic emergency for an agricultural activity. 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 approved.
A Federal or State agency must submit an emergency exemption
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 that may be posed
to human health or to the environment as a result of the pesticide use
(40 CFR 166.20). EPA reviews 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 also 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
approve 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 section 18 and 40 CFR part
166, and, for food uses, section 408 of FFDCA, then EPA may authorize
emergency use of the pesticide.
Use under specific and public health exemptions can be authorized
for periods not to exceed 1 year, and uses under quarantine exemptions
can be authorized for up to 3 years (40 CFR 166.28). Public health
exemptions are for the control of pests that will cause a significant
risk to human health, while quarantine exemptions are intended to
control the introduction or spread of pests that are new or not known
to be widely prevalent or distributed within and throughout the United
States and its territories. Emergency exemptions should not 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 registration or seek a new registration to address
that future need.
IV. Background
A. April 2003 Notice Initiating Pilot for Two Revisions Now Being Proposed
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 two potential improvements currently being
piloted are: (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 submit complete new
applications and, (2) a new approach to documenting a significant
economic loss that focuses on the significance of the potential loss
relative to yields and/or revenues without the emergency rather than
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 proposed rule, without
the restriction to reduced-risk pesticides that limits the scope of the
pilot.
Anyone interested in the background leading up to the pilot
program, or other related documents, may wish to review the Federal
Register Notice announcing the pilot, and the related documents. A
public docket was established for that Notice under docket ID number
OPP-2002-0231. Interested parties should follow instructions under
ADDRESSES for accessing the docket, but use docket ID number OPP-2002-
0231 to access the docket for the April 24, 2003 Notice.
B. Summary of Early Pilot Experience
The pilot program is limited to requests for a specific set of
``reduced-risk'' pesticides, which significantly limits the number of
potentially eligible exemption requests. The summary of participation
in the pilot focuses on the 2003 growing season, since the 2004 season
was still underway at this time.
The first part of the pilot allowed applicants for eligible repeat
exemptions to re-certify the existence of their emergency condition.
The re-certification pilot involves exemptions that meet all of the
following eligibility criteria: (1) EPA approved the same exemption the
previous year, and it is the second or third year of the request
[[Page 53869]]
by that applicant, (2) the emergency situation can reasonably be
expected to continue for longer than 1 year, (3) the exemption is not
for a new chemical, a first food use, or for a chemical under Special
Review, and (4) the exemption is for a chemical previously identified
by EPA as reduced-risk. For the 2003 growing season, 16 exemptions were
identified by EPA as eligible for re-certification and the list was
made available to States and the public. Of the 16 exemptions eligible
to repeat by re-certification, 7 submitted applications using re-
certification. Of the nine exemptions that were eligible but for which
no re-certification was submitted, three were for pesticide uses that
had obtained federal registration under FIFRA section 3 since the 2002
exemption; three were not requested at all in 2003; and the remaining
three were requested using conventional emergency exemption requests.
In the seven instances of a re-certification, EPA staff was able to
make expedited decisions with an average of 9 days from receipt of the
request until the decision was made.
The second part of the pilot, for the loss-based approach for
determining a significant economic loss, is limited only by the
restriction to reduced-risk pesticides. Unlike the re-certification
part of the pilot, there is no specific list of eligible exemptions,
only eligible pesticide active ingredients to be requested. Therefore,
there is no fixed number of eligible exemptions for the loss-based
economic approach. EPA did not receive any submissions using the loss-
based approach for determining a significant economic loss under the
terms of the pilot during the 2003 growing season, although we have
already received some in 2004. For the past year, the Agency has
routinely prepared side-by-side assessments that evaluate the data
under the traditional method, as well as the loss-based approach
outlined in the pilot, to gain a better understanding and compare the
ways of measuring whether pest situations represent emergencies. The
loss-based approach is considered to measure more accurately the
significance of losses associated directly with the pest problem, and
is less influenced by other factors such as market fluctuations. In
addition, cursory assessments of available past submissions have been
done using the loss-based approach.
Both of these proposed revisions offer a cost saving and reduce the
burden on States as well as on EPA. The Agency expects that the level
of participation in both areas of the pilot will increase as the level
of familiarity and understanding among State agencies increases.
Efforts to facilitate the understanding and use of the pilot
initiatives are currently underway.
V. Proposed Revisions to Emergency Exemption Process
The two revisions discussed below are currently being employed in
limited pilot programs that were initiated by a Federal Register Notice
in April 2003. A guidance document was prepared for use by applicants
to participate in the pilot programs. After reviewing this Unit V.,
interested parties may find it useful to review that guidance document
for the Agency's detailed plans for implementation of these revisions.
A final guidance document will be made available when a final rule is
published. In the meantime, the guidance document for the pilot would
be particularly helpful in understanding what information would be
required to be submitted by applicants under the proposed revisions.
The pilot guidance document for the 2004 growing season is available in
the public docket. Interested parties should follow instructions under
ADDRESSES.
A. Re-certification of Emergency Condition by Applicants
1. 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 that
caused the emergency, some exemptions may subsequently be approved
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 human health 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).
If the emergency condition continues in subsequent years,
applicants may submit a similar application, 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, with a full application,
including updated economic data. For these repeat requests 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; (4) the
requested conditions of use have changed; and (5) the pesticide for the
requested use has made sufficient progress towards registration.
2. How would re-certification work under the proposed approach?
This proposed revision would reduce the burden on applicants who seek
re-approval of certain emergency exemptions in subsequent years. EPA
proposes to add a new paragraph (b)(5) to 40 CFR 166.20, which would
allow applicants for eligible repeat exemptions to submit applications
that rely on the preceding year's submission to document the economic
impact of the pest emergency. This re-certification approach would
allow applicants to incorporate by reference all information submitted
in a previous application, instead of submitting a complete re-
application and supporting documentation. The re-certification of the
emergency condition by the applicant combined with the materials
already in EPA's files would serve as the basis for EPA's determination
as to whether an emergency condition continues to exist.
Upon approval of any emergency exemption, EPA would make an up-
front, separate, additional determination regarding eligibility for a
streamlined re-certification application the following year, in the
event that the applicant reapplies the next year. Eligibility for a re-
certification application would not determine whether an emergency
exemption application could be approved. Rather eligibility would
affect the information that should be submitted in the application. EPA
would consider several factors in determining 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 would
include a temporary supply problem of a registered product, an isolated
weather event, or a sporadic pest outbreak.
2. Whether an emergency exemption has been approved more than twice
for the same pesticide at the same site. EPA recognizes that some
emergency situations can continue for more than 1 year, however,
pesticide registration
[[Page 53870]]
pursuant to FIFRA section 3 is the appropriate long-term response,
rather than the section 18 emergency exemption. According to the
regulations and EPA policy, a failure to request registration of a use
requested under section 18 for more than 3 years may indicate that
adequate progress toward registration is not being made. Therefore, EPA
carefully examines all exemption submissions submitted for more than 3
years.
3. Whether the pesticide product, owing to its regulatory status,
warrants heightened review before any additional use is approved. EPA
will rely 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:
(1) The application proposes use of a new chemical.
(2) The application proposes the first food use of an active
ingredient.
(3) The application proposes any use of a pesticide if the
pesticide has been subject to a suspension notice under section 6(c) of
the Act.
(4) The application proposes use of a pesticide which:
(i) Was the subject of a notice under section 6(b) of the Act and
was subsequently canceled.
(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).
(5) The application proposes use of a pesticide which:
(i) Contains an active ingredient which is or has been the subject
of a Special Review.
(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.
In instances where EPA determines that the emergency situation
could reasonably be expected to continue, where an emergency exemption
has been approved not more than twice for the same pesticide at the
same site, and where the pesticide product's regulatory status does not
warrant heightened review, EPA would notify the successful applicant
that, should it re-apply the following year, it is eligible to use a
re-certification application. EPA anticipates that this notification
would 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 is 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
is eligible for re-certification upon submission of the specified
information.
Under the proposed rule, an eligible re-certification applicant
would be exempted from the information requirements of 40 CFR
166.20(a)(1) through (a)(10), and of the existing 40 CFR 166.20(b),
where the applicant certifies that:
(i) The emergency condition described in the preceding year's
application continues to exist.
(ii) Except as expressly identified, all information submitted in
the preceding year's application is still accurate.
(iii) Except as expressly identified, the proposed conditions of
use are identical to the conditions of use EPA approved for the
preceding year.
(iv) Any conditions or limitations on the eligibility for re-
certification identified in the preceding year's notice of approval of
the emergency exemption have been satisfied.
Applicants meeting the above requirements would not need to submit
new, updated documentation that the emergency condition continues or
the additional data elements generally required under 40 CFR 166.20,
except that the interim report specified in 40 CFR 166.20(a)(11) would
still be required where a re-certification is filed before the final
report on the previous exemption is available.
Eligibility for re-certifying the emergency condition would not
determine whether an emergency exemption application could be approved.
For applications that are eligible and include a proper re-
certification of the emergency condition, EPA would again determine
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 would be denied unless the risks could be mitigated.
Where an application re-certifies that the emergency condition and
requested use are the same as in the initial year of the exemption, EPA
would 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; (3) the requested conditions of use
have changed; and, (4) the pesticide for the requested use has made
sufficient progress towards registration. If an effective product has
been registered for the requested use since the previous exemption was
approved, then an emergency condition may no longer exist. If the
Agency has received new risk information since approving the previous
exemption, then the risk would be re-evaluated. Likewise, if the
request includes any change in the conditions of use that 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 would also be
re-evaluated. Because some applicants may start their 3-year re-
certification period in later years than others, it is possible that
EPA may determine that sufficient progress towards registration has not
been made for a pesticide requested by an applicant eligible for re-
certification.
For eligible requests where the applicant has certified a
continuing emergency, if the three remaining review factors (product
registrations, risk assessment status, and requested conditions of use)
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 would be permitted to
modify the conditions of the emergency use in an application in which
they re-certify the emergency. However, EPA would need to determine
whether, and how, such changes impact exposure and risk to human health
or the environment. Therefore, such changes may undercut the Agency's
ability to make an expedited decision. If the conditions of use are the
same as the conditions of use in the exemption approved by EPA in the
previous year, applicants may include a separate certification that
their requested conditions of use have not changed, and incorporate by
reference all conditions of use submitted in a previous application or
applications. This certification that the conditions of use are
unchanged would 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 submitting a re-
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certification application. Registrant progress toward registration is
determined for a pesticide-crop combination, whereas the year-count
(first, second, third) in the eligibility cycle for re-certification
would be determined separately for each State/Federal applicant, and
could often differ among section 18 applicants in a given year. Lack of
progress towards registration would 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.
It is EPA's view that section 18 applies to non-routine conditions,
and thus the Agency does not expect to re-approve emergency exemptions
indefinitely. Under this proposal EPA would not allow submission of re-
certification applications where exemptions have been previously
granted for 3 or more years. As provided in 40 CFR 166.25(b)(2)(ii), an
applicant for an emergency exemption for a use that has been subject to
an emergency exemption in 3 previous years will be required to
demonstrate reasonable progress towards registering the product for the
use, as part of a full application.
3. Why propose this change? Allowing applicants for certain
eligible exemption requests to re-certify the existence of an ongoing
emergency condition and to incorporate by reference all information
submitted in a previous application 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
each step of its review of the documents supporting the exemption
requests. If no pesticides that could 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.
EPA's experience indicates that emergency situations that continue
after the initial year generally are projected to cause comparable
yield losses in succeeding years. Therefore, with the certification of
a continuing emergency, reliance on the previously submitted data and
other supporting information should be adequate to support a decision
to approve or deny an emergency exemption application.
B. Determining and Documenting ``Significant Economic Loss''
1. What is our current practice? In determining whether a pest
emergency is likely to result in ``significant economic loss,'' EPA
ordinarily compares the affected growers' projected per-acre
``profits'' (gross revenue less expenses, where expenses have often
been poorly defined) for the affected crop, based on anticipated yield
losses, to the historical variation in their ``profits'' for that crop
in that region. Applicants are required under 40 CFR 166.20(b)(4) to
submit economic information necessary to make this determination. In
addition to information used to estimate the amount of the anticipated
yield and profit losses, EPA generally asks for annual data for 5 years
of average yields, prices, and production costs to establish profit
variability.
Under the current approach, EPA and applicants estimate expected
net revenues under the emergency conditions and compare them to the
variation in annual profitability during the previous 5 years. If the
expected net revenues under the emergency are less than the smallest
net revenues of the previous 5 years, then the Agency would typically
conclude that a significant economic loss will occur. Some crops have
very wide fluctuations in net revenues (that in many cases are the
result of market forces entirely unrelated to pest pressure). For such
crops, growers may experience a large economic loss due to non-routine
pest-related conditions, without a significant economic loss finding by
EPA under strict adherence to the current approach. Other crops may
have very little variation in historical net revenues, which could lead
to a very small economic loss being found significant under the current
approach.
2. How would the proposed approach work? This second proposed
improvement would focus EPA's analysis on the economic impact of the
pest emergency relative to yields and/or revenues without the pest
emergency, rather than comparing it to historical profit variation for
the crop and region. Moreover, the new approach would allow applicants
to document economic losses with a less burdensome methodology where
appropriate.
The proposed loss-based approach would use the existing methodology
to calculate the economic consequences of an unusual pest outbreak,
although the calculation would be done in steps (tiers) and sometimes
the later steps would be unnecessary. States would still have to submit
data to demonstrate the emergency nature of the outbreak including the
expected losses in quantity, and sometimes quality and/or additional
production costs. However, the proposed approach would impose standard
criteria for determining the significance of that loss, rather than
comparing losses to past variations in revenue or profit. The goal of
the criteria is to compare losses to farm or firm income in the absence
of the emergency in a manner that can be easily and consistently
measured. Further, successive screening levels (tiers) have been chosen
that will permit situations that clearly qualify to be resolved
quickly, with a minimum of data. Each tier has a quantitative threshold
that would generally apply to all eligible emergency exemption
applications. If the pest situation does not appear likely to result in
a significant economic loss based on the first tier analysis, it might
qualify based on further analysis in succeeding tiers. Each additional
tier would require more data and involve more analysis on how the
emergency affects revenues. Where conditions do not neatly fit into the
tiered approach, for example long-term losses in orchard crops, the
Agency would make its significant economic loss determinations based on
other criteria, such as changes in the net present value of an orchard,
if these losses are demonstrated by the applicant.
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 would conclude that a significant economic loss will occur,
due to the magnitude of the expected revenue loss. The yield loss
threshold in Tier 1 would be 20% for all crops. This threshold is set
at a sufficiently high level such that a loss that exceeded the
threshold would 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 would not be necessary to separately
estimate economic loss, which would require detailed economic data.
Tier 2: Economic loss as a percentage of gross revenues. A yield
loss that does not satisfy the threshold in Tier 1 may nonetheless
cause a significant economic loss because yield loss alone may not
reflect all economic losses. In addition to yield losses, there may be
other impacts that contribute to economic loss. Quality losses may result
[[Page 53872]]
in reductions in prices received and/or there may be 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 would 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 would be 20% of gross revenue for all crops. Again,
this threshold in Tier 2 is set with the intention that losses
exceeding the threshold would also meet the threshold in Tier 3, if the
additional Tier 3 analysis were performed.
Tier 3: Economic loss as a percentage of net revenues. If neither
yield or economic losses were above the required thresholds in Tiers 1
and 2, EPA would compare impacts to net revenues. Net revenues are
defined for the purposes of this proposed rule as gross revenues minus
operating costs. The loss threshold in Tier 3 would be 50% of net
revenues for all crops. Some emergency conditions that would 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 (net revenues as a percentage of gross revenues). Even if
economic loss seems small in comparison to gross revenues, the
situation could still be a significant economic loss if the profit
margin is narrow.
EPA selected the sizes of the proposed thresholds (20%, 20%, and
50%) based on average farm income and production expenses in the U.S.,
and an analysis of past requests showing what results the proposed
method would provide with various thresholds. Data on farm income in
``USDA Agricultural Statistics, 2003'' shows that net farm income
averages about 20% of gross revenue. Therefore, an economic loss of 20%
of gross revenue would be sufficient to eliminate net farm income. A
yield loss of 20% results in economic loss of 20% or higher. Also,
since average net farm income is a little less than 50% of net revenue,
an economic loss that is 50% of net revenue would be sufficient to
eliminate net farm income. The analysis of past requests indicated that
the average and median economic losses that qualified as a significant
economic loss were about 18% and 15% of gross revenue, respectively.
Since the first 2 tiers are screening thresholds, these thresholds were
rounded up to 20% to be a little more stringent, with the intention
that if a request did not pass Tiers 1 or 2, it could qualify with Tier
3. The analysis of past requests also showed that the median economic
loss that qualified as a significant economic loss was about 51% of net
revenue. The analysis also showed that these thresholds collectively
result in about the same overall likelihood of an application
qualifying for a significant economic loss. That is, approximately the
same total number of emergency requests that qualified for a
significant economic loss using the current approach would qualify
using the proposed loss-based approach, although there would be some
differences in individual cases.
The regulatory revisions in this proposed rule include the
quantitative thresholds for the three tiers, presented above, as this
is EPA's preferred approach. Commenters are asked to consider whether
the actual thresholds should be included in the revised regulations, or
whether more flexibility should be preserved to refine that aspect of
the proposed approach in the future. Commenters should also consider
whether the levels of the proposed thresholds are appropriate, and if
not, what the levels should be and why.
For specific emergency exemptions (the only ones in which
significant economic loss is a qualifying factor), EPA anticipates that
applicants would first determine whether their projected loss meets the
Tier 1 yield loss threshold of 40 CFR 166.3(h)(1)(i), analytically the
least burdensome criterion. The associated data requirements are
proposed in 40 CFR 166.20(b)(4)(i). If the projected loss does not meet
this threshold, EPA expects that applicants would determine whether
their projected loss meets the Tier 2 gross revenue threshold of 40 CFR
166.3(h)(1)(ii), providing additional data as noted in 40 CFR 166
20(b)(4)(ii). Failing to meet that threshold, applicants would submit
the data to perform the analysis necessary for the Tier 3 net revenue
threshold of 40 CFR 166.3(h)(1)(iii) as given in 40 CFR
166.20(b)(4)(iii). The three tiers established in 40 CFR
166.3(h)(1)(i), (ii) and (iii) are designed such that when an emergency
condition qualifies for significant economic loss under a lower tier,
data for higher tiers are not required, and the burden and cost of
preparing the emergency exemption application 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 would allow an applicant to collect data, and
build a case for significant economic loss, as needed and determined by
the conditions, without requiring additional unnecessary data.
This loss-based approach is designed to capture the economic impact
of pest activity as it affects the current growing season, which will
be sufficient for most emergency exemption applications. Although the
loss-based approach appears in a proposed revision to the definition of
significant economic loss at 40 CFR 166.3(h)(1), EPA is not attempting
to revise the approach for other types of losses, at the proposed 40
CFR 166.3(h)(2). Where losses affect more than the current growing
season, for example long-term losses in orchard crops, the Agency would
continue to make its significant economic loss determinations based on
other criteria, such as changes in the net present value of an orchard,
if these losses are demonstrated by the applicant. In situations where
the simple methods of the loss-based approach would not adequately
reflect the likely extent of the economic loss, EPA would still attempt
to determine, on a case-by-case basis, whether the pest emergency is
likely to result in a substantial loss or impairment of capital assets,
or a loss that would affect the long-term financial viability expected
from the productive activity.
3. Why propose this change? This proposed methodology for
determining a significant economic loss is intended to streamline the
data and analytical requirements for emergency exemption requests, and
allow for quicker decisions by EPA. In addition, the methodology is
designed to reflect more accurately the significance of an anticipated
economic loss. Specifically, this approach makes a more direct
comparison between the losses anticipated owing to the emergency
situation and the yield and/or revenues without the pest emergency,
rather than a comparison to the historical range of profit variability.
Year-to-year profit variability often reflects market forces entirely
unrelated to pest pressure. Although EPA has attempted to make
allowances for crops' differing profit variability when determining the
economic significance of losses under the current approach, EPA now
believes that the loss-based approach better and more directly permits
EPA to evaluate the significance of economic losses.
An analysis of past section 18 requests suggests that this proposed
approach would 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 savings to both
applicants and EPA from reduced data and analytical burdens. Under the
proposed procedure, applicants could elect to submit the
[[Page 53873]]
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 current
approach as the analysis focuses on the current year rather than
historical data. Like re-certification of emergencies, this would save
applicants time and resources in gathering data and preparing
submissions. The Agency's burden would be reduced due to streamlined
reviews.
An analysis of available past requests for emergency exemptions
submitted by States, including requests for which significant losses
were not found, shows that in many cases significant economic loss can
be adequately demonstrated in a more flexible manner without loss of
reliability through the proposed methodology. The loss-based approach
would require less data from applicants in cases that qualify under
Tier 1, where the same conclusion of a significant economic loss would
be made with the additional data and analysis under the higher tiers.
Because the proposed approach shifts the focus from annual price
variability to actual pest-related losses, while still considering
typical net revenues for the crop and State, it leads to more
consistently accurate findings of the significance of economic losses.
Under the current approach, producers of crops that have very wide
fluctuations in net revenues, even if due to price variability, may
experience a large economic loss due to non-routine pest-related
conditions, without a significant economic loss finding by EPA under
strict adherence to the current approach. Other crops and cases may
have very little variation in historical net revenues, which could lead
to a small economic loss being found significant under the current
approach. Again, the proposed approach is designed so that it would not
cause a significant change in the overall likelihood of a significant
economic loss finding, but it may change the findings in individual
cases so that determinations of significance are more accurate,
appropriate and equitable.
Current regulations list certain information that must be included,
as appropriate, in an application for a specific exemption: 40 CFR
166.20(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 existing regulations state that all of the above information
must be included ``as appropriate.'' EPA recognizes that each pest
emergency has individual characteristics, and exercises judgement based
on experience, in determining what information 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, and has suggested in guidance materials that applicants
submit revenue data for the preceding 5 years. However, in some cases,
such as a very minor or new crop for which less data are available, the
Agency may rely on other credible information. Further, EPA does not
compare the emergency situation to the situation with the proposed
pesticide, but to the situation without the emergency. Therefore, EPA
believes that the proposed approach would 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
proposed approach is based, demonstrates that the likelihood of
approval of some requests is not significantly changed by the loss-
based approach, EPA believes that the current requirement of those
additional data in those cases can be improved. However, even when
annual historical data are not required, applicants would sometimes
continue to utilize historical data under the proposed approach, albeit
in a different way. This is because each tier requires a quantitative
threshold to be met, that is a certain percentage of a baseline of
either crop yield, gross revenues, or net revenues. The best approach
to determine the baseline in some cases may be to use the average of
historical data, including yield and price data.
VI. Proposed Minor Updates and Revisions
A. Specifying Invasive Species as Targets under Quarantine Exemptions
Current regulations describe four types of exemptions, one of which
is a quarantine exemption. The purpose of a quarantine exemption is
stated in the regulations as follows:
40 CFR 166.2(b) Quarantine exemption
A quarantine exemption may be authorized in an emergency
condition to control the introduction or spread of any pest new to
or not theretofore known to be widely prevalent or distributed
within and throughout the United States and its territories.
Quarantine exemptions are not directly for the purpose of, or
approved on the basis of, averting a significant economic loss,
although they may ultimately help prevent large economic losses. In
addition to being for the control of pests that are not widely
prevalent or distributed in the U.S., quarantine exemptions are
intended to control recently-introduced, non-native species. In recent
years such species have come to be commonly known as ``invasive
species.'' Because of the potentially widespread and devastating
impacts of invasive species to ecosystems, the environment, and the
economy, the challenge of preventing their introduction, and when
necessary controlling them, has garnered increasing attention in recent
years. Although invasive species implicitly fall within the scope of
quarantine exemptions, the now widely-recognized term does not appear
in the regulations, probably because it was not widely used at the time
40 CFR part 166 was promulgated. EPA is proposing to add the term
``invasive species'' to 40 CFR 166.2(b) and to 166.3(d)(3)(i), to
clarify that the intent of making quarantine exemptions available
includes the control of invasive species. EPA also proposes to add, at
40 CFR 166.3(k), a definition of ``invasive species'' that is derived
from that used in Executive Order 13112 (64 FR 6183, February 3, 1999).
B. Updating Administrative and Communication Processes
A number of minor revisions to 40 CFR part 166 are being proposed
to correct errors or update administrative aspects of the emergency
exemption regulations, particularly in light of the fact that FQPA was
enacted since the regulations under part 166 were last revised. Each of
these revisions is being proposed for one of the following reasons: (1)
To correct typographical or administrative errors or inaccuracies, (2)
to bring the regulations into agreement with current requirements put
in place by the FQPA, or (3) to reflect improvements to the process
that have been identified since 40 CFR part 166 was last revised, and
that have been voluntarily practiced by applicants. Each of these
revisions would be non-substantive or reflect minor changes to
[[Page 53874]]
the regulatory requirements, but all would correct, improve, or update
the regulations. The corrections of typographical or administrative
errors or inaccuracies are self-explanatory. The proposed revisions for
the other reasons are discussed below.
Under FFDCA section 408(l)(6), as amended by FQPA, EPA is required
to establish time-limited tolerances, or exemptions from the
requirement of a tolerance, for pesticide residues in food or feed
resulting from uses under emergency exemptions. The current regulations
predate FQPA and therefore do not reflect this requirement. Four
revisions are being proposed to bring 40 CFR part 166 into agreement
with current practices as required by the FFDCA. Inasmuch as section
408(l)(6) applies to all food-use emergency exemptions, regardless of
whether its requirements are reflected in 40 CFR part 166, these
proposed changes to 40 CFR part 166 do not substantively change the
applicable law. For ease of discussion, below, ``tolerance'' is used to
refer to a tolerance or exemption from the requirement of a tolerance.
First, EPA proposes to amend 40 CFR 166.3(e) to revise the
definition of ``first food use,'' which reads ``The term first food use
refers to the use of a pesticide on a food or in a manner which
otherwise would be expected to result in residues in a food, if no
permanent tolerance, exemption from the requirement of a tolerance, or
food additive regulation for residues of the pesticide on any food has
been established for the pesticide under section 408(d) or (e) or 409
of the Federal Food, Drug, and Cosmetic Act.'' EPA is proposing to
change this definition by removing the word ``permanent,'' so that the
establishment of any tolerance, including a time-limited tolerance,
would be considered when determining whether a use was the first food
use, and by removing the reference to ``food additive regulation,''
because, owing to the FQPA amendments, EPA no longer issues food
additive regulations.
Second, under 40 CFR 166.25, Agency review, the regulations state
that the review enables EPA to make a determination with respect to
several items, including in 40 CFR 166.25(a)(2) the level of residues
in or on all food resulting from the proposed use. The proposed
revision would add to this list the establishment of a time-limited
tolerance for such residues, where necessary.
The third proposed revision made necessary by FQPA is to add, under
40 CFR 166.40, an additional limitation to the authority of a State to
issue a crisis exemption, namely, that a State may issue a crisis
exemption for a food use only where a tolerance or exemption is already
in effect, or where EPA has provided verbal confirmation that a time-
limited tolerance for the proposed use can be established in a timely
manner. It is in the best interests of applicants and potential users
of the pesticide under the crisis exemption that there is some
assurance that an exemption can be established in a timely manner
before use of the pesticide begins. EPA also proposes that all crisis
exemptions be conditioned upon EPA confirming that it has no other
risk-based objection to the use of the pesticide under the crisis
provisions.
The fourth proposed change, which arises because EPA now
establishes formal tolerances under FQPA, is to remove the requirement
under 40 CFR 166.30(b) and 40 CFR 166.47 to directly notify the U.S.
Food and Drug Administration (FDA), the U.S. Department of Agriculture
(USDA), and the State health officials. The purpose of this requirement
was to notify these agencies of levels of pesticides that may occur in
food and feed items as a result of an emergency exemption use. However,
with the requirement that time-limited tolerances be established in
accordance with FFDCA section 408(l)(6), such levels are published in
the Federal Register, as well as the 40 CFR part 180, and detailed
background is given regarding safety of these tolerances. Therefore,
notifying the other regulatory organizations (FDA, USDA, and State
health officials) on an individual basis is considered redundant to the
Federal Register notice and incorporation of the regulatory decision in
the appropriate section of 40 CFR part 180.
Several proposed revisions are to codify minor improvements to the
process that have been identified since the current regulations became
effective. Applicants have been generally following these practices, in
most cases for several years, and EPA believes that the public will
generally agree that these are improvements to the regulatory
requirements. First, under 40 CFR 166.20, Application for a specific,
quarantine, or public health exemption, EPA is proposing to revise 40
CFR 166.20(a)(2)(i)(A) so that an application must include a copy of
the registered label(s) if a specific pesticide product(s) is/are
requested, instead of the current requirement to include the
registration number and name of the product. This is practical because
emergency exemption requests are generally for pesticide products that
are already registered for other uses, but not for the requested use.
Next, under 40 CFR 166.20(a)(3), EPA is proposing to add a new item
and revise several of the others, to specify that the conditions of use
in an application must state the maximum number of applications, the
period of time for which the use is proposed, and to specify the
earliest possible harvest dates of the treated crop. Such information
is clearly necessary for both risk assessment and tolerance setting,
and in those rare occasions where it is not apparent from the
application, EPA must contact the applicant to obtain the information.
Expressly requiring this information in 40 CFR 166.20(a)(3) would
expedite review of applications and allow tolerances to be established
in a timely fashion.
Additionally, EPA is proposing that 40 CFR 166.20(a)(9) be revised
to specify that in addition to the registrant or manufacturer being
notified of the application submission, the application must also
include a statement of support from the registrant or manufacturer, and
the expectation that supplies of the requested material will be
adequate to meet the needs under the proposed emergency use.
The existing regulations establish a measure of whether adequate
progress toward the registration of a requested use is being made.
Existing regulations suggest that the lack of a request for
registration, within 3 years of an emergency exemption first being
requested for the use, suggests that adequate progress is not being
made. EPA proposes to revise 40 CFR 166.24(a)(6)(i) and 40 CFR
166.25(b)(2)(ii) to relax this presumption for repeat emergency
exemption applications for uses being supported by the Interregional
Research Project No. 4 (IR-4). The IR-4 program is a cooperative effort
of the state land grant universities, USDA and EPA, to address the
chronic shortage of pest control options for minor crops. Generally,
the crop protection industry lacks economic incentive to pursue
registrations on minor crops because of low acreage. IR-4 generates and
supplies research data needed by EPA in order to register compounds for
use on minor crops. Owing to the limited pest control options available
for minor use crops, the significance of the need evidenced by IR-4
action, and the limits on IR-4 resources, EPA believes that a somewhat
slower rate of progress towards registration should be accepted for
emergency exemptions for uses being supported by the IR-4 program.
Accordingly, EPA is proposing that 40 CFR 166.24(a)(6)(i) and 40 CFR
[[Page 53875]]
166.25(b)(2)(ii) be revised so that the presumption against adequate
progress toward registration of repeat emergency exemptions for uses
being supported by the IR-4 program would begin after 5 years, 2 years
more than allowed for uses supported by the registrant. For such major
crop uses, the 3-year presumption in the current regulations would
remain in effect.
EPA is proposing that 40 CFR 166.30(a)(1) be revised to reflect
that EPA will not process incomplete applications, and that action on
such submissions will be halted until required additional information
is submitted.
EPA is proposing to clarify 40 CFR 166.32(b) to ensure that
applicants submit interim use reports for exemptions if requesting a
repeated emergency exemption prior to the due date of the final report.
EPA proposes clarifying the authority of an applicant to issue a
crisis exemption by specifying in 40 CFR 166.40(a) that crisis
exemptions are to be used only for unpredictable emergency conditions.
This proposed change is strictly for purposes of clarification, as the
term ``unpredictable'' already appears in the introductory language of
40 CFR 166.40, and does not represent any intention by EPA to change
the circumstances that are acceptable for crisis exemptions.
EPA is proposing that 40 CFR 166.43(a)(1) be revised to improve the
notification process for crisis exemptions, reflect the standard
practice of the state agencies, and provide for advance notice so that
EPA may make a determination of whether a tolerance may be supported in
accordance with FFDCA section 408 requirements. EPA is proposing that
40 CFR 166.43(a)(1) be revised to require advance notification for
crisis exemptions by applicants. The state's authority to exercise the
crisis exemption would be stayed for up to 36 hours pending verbal
confirmation by EPA that a tolerance can be established in a timely
manner and that the Agency has no other risk-based objections. This
would replace the currently ambiguous requirement that notification
must be made at least 36 hours in advance, or no later than 24 hours
after the decision of a State to avail itself of a crisis exemption.
Notification after the crisis has been declared does not allow EPA to
evaluate whether a crisis use can be supported with a section 408
safety finding, or whether other potential risks are unacceptable,
before use of the pesticide begins. In any case, EPA would continue to
provide the necessary verbal confirmations as quickly as possible,
thereby often allowing use of the crisis exemption in less than 36
hours. The Agency recognizes that speed is important for all crisis
exemptions, and that certain situations may be particularly urgent,
including, but not necessarily limited to, national security threats
and some requests under USDA's Animal and Plant Health Inspection
Service quarantine program.
To clarify necessary information for a crisis exemption, EPA is
proposing that 40 CFR 166.43(b)(1) and (b)(4), be revised to specify
submission of the registered label(s) for the pesticide product(s)
proposed for crisis use, as well as proposed use directions specific to
the crisis use, and the timeframe for anticipated use, including end date.
To bring the reporting requirements for crisis exemption requests
into agreement with those for specific, quarantine, and public health
exemption requests, EPA is proposing that 40 CFR 166.49(a)(1) through
(a)(4) be revised and 40 CFR 166.49(a)(5) deleted, to clarify
information requirements, such as applicant, product used, site
treated, and contact information.
VII. EPA Plans for Resistance Management and Endangered Species
Considerations
A. Revised Plans for Addressing Resistance Management
The EPA-USDA Committee to Advise on Reassessment and Transition
(CARAT) is a diverse group of stakeholders formed to make
recommendations to EPA and USDA regarding strategic approaches for pest
management planning, transition to safer pesticides for agriculture,
and tolerance reassessment for pesticides. In October 2003, CARAT
provided draft recommendations, including one that ``EPA and USDA need
to recognize that any transition program has to consider efficacy,
economics, resistance management, and impact on non-targets.'' EPA
agrees with the CARAT on the importance of resistance management and is
exploring how to use its regulatory and non-regulatory initiatives to
support and facilitate effective resistance management.
Although the April 2003 Federal Register Notice indicated that EPA
was considering addressing resistance management in this proposed rule,
EPA now plans to pursue opportunities to address pest resistance
management as it implements the Pesticide Registration Improvement Act
(PRIA) enacted January 23, 2004. This Act requires the Agency to
establish a registration service fee system for applications for
pesticide registration and amended registration. Under this new system,
fees will be charged for new applications for registration received on
or after the effective date of the statute (March 23, 2004) and EPA is
required to make a decision on the application within prescribed
decision timeframes. Under PRIA, EPA will eliminate its backlog of
registration actions and make more timely decisions. This will
accelerate the registration of many products that will be beneficial to
resistance management, including reduced risk products. EPA's reduced
risk process considers resistance management as an important factor.
New products that would address significant resistance management needs
would reach the market sooner, thereby providing a strong incentive to
registrants to incorporate resistance management in their registration
submissions.
In addition, EPA will continue to promote the implementation of its
voluntary resistance management labeling guidelines based on rotation
of mode of action described in Pesticide Registration Notice 2001-5 (PR
Notice 2001-5). These guidelines are part of a North American Free
Trade Agreement (NAFTA) effort to harmonize resistance management
guidelines. The Agency supports incorporating resistance management
considerations into pesticide labeling (i.e., PR Notice 2001-5),
resistance management education programs, crop management and
stewardship programs, and outreach efforts with stakeholders. EPA will
continue working with stakeholder groups on sustainable resistance
management strategies that protect human health and the environment
including the various Resistance Action Committees (RACs), registrants,
consultants, academia, USDA, States, and public interest groups.
B. Protections for Endangered Species
Like all federal agencies, EPA must comply with the requirements of
the Endangered Species Act (ESA), which requires that an agency ensure,
in consultation with the U.S. Fish and Wildlife Service (FWS) and the
National Marine Fisheries Service (NMFS) (jointly referred to as ``the
Services''), that its actions are not likely to jeopardize the
continued existence of threatened or endangered (listed) species or
destroy or adversely modify their critical habitat. This requirement
applies, among others, to EPA actions approving emergency exemptions
under FIFRA section 18. Under current ESA consultation regulations, an
agency must consult with FWS and NMFS if an
[[Page 53876]]
action ``may affect'' a listed species or its critical habitat.
FWS and NMFS, in collaboration with EPA and USDA, have developed a
counterpart regulation (69 FR 48115, August 6, 2004), that would make
the process of consultation about EPA actions involving pesticides more
efficient, effective, and timely, thereby strengthening the protections
for endangered and threatened species. As part of the work supporting
the counterpart rule, the Services and EPA reviewed the Agency's
approach to the assessment of potential risks to listed species
resulting from pesticide use. A January 26, 2004, letter from the
Services to EPA includes a quote stating that EPA's approach to
ecological risk assessment ``will produce effects determinations that
reliably assess the effects of pesticides on . . . listed species and
critical habitat pursuant to the ESA and implementing regulations.''
That letter is in the public docket for this proposed rule, and
interested parties may access it by following the instructions under
ADDRESSES.
As a result of the Services' review of the Agency's ecological risk
assessment methodology, EPA intends to look more closely at potential
risks of pesticide use in connection with decisions on requests for
emergency exemptions. EPA currently requires, under 40 CFR
166.20(a)(7), information to be included in applications for emergency
exemption that addresses potential risks of the requested use to
endangered and threatened species. Although EPA, under existing
requirements, routinely considers the impacts of emergency exemptions
on endangered and threatened species, the Agency seeks to improve the
guidance it gives to applicants concerning data on endangered and
threatened species. EPA will need to rely on States and federal
agencies to supply information as part of their requests for emergency
exemptions that will enable EPA to assess the potential impacts on
listed species and critical habitat of pesticide use under the proposed
exemption. EPA also plans to work with the Association of American Pest
Control Officials (AAPCO) and with individual States, as the primary
applicants for emergency exemptions, to improve the quality of their
submissions as they try to frame the potential impact of a requested
pesticide use on endangered and threatened species. EPA believes these
measures fall within existing requirements but should increase the
availability of essential information needed to make a timely and
substantive determination of the potential impact to endangered and
threatened species. EPA also plans through its reevaluation, to refocus
and possibly increase consideration of these impacts in its decision
process for exemption requests, including any need to consult with
USFWS and NMFS.
VIII. FIFRA Review Requirements
In accordance with FIFRA section 25(a), this proposed rule was
submitted to the FIFRA Science Advisory Panel (SAP), the Secretary of
Agriculture (USDA), and appropriate Congressional Committees. The SAP
has waived its review of this proposed rule, and no comments were
received from any of the Congressional Committees or USDA.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866
Pursuant to Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has designated this proposed rule as a ``significant
regulatory action'' under section 3(f) of the Executive Order because
it may raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order. This action was therefore submitted to OMB for
review under this Executive Order, and any changes to this document
made at the suggestion of OMB have been documented in the public docket
for this rulemaking.
In addition, EPA has prepared an economic analysis of the potential
regulatory impacts of this proposed action on those affected, which is
contained in a document entitled Economic Analysis of the Proposed
Pesticides Emergency Exemption Process Revisions. A copy of this
Economic Analysis is available in the public docket for this action and
is briefly summarized here.
EPA is considering these improvements in an effort to reduce the
burden to both the applicants and EPA, and to allow for quicker
decisions by the Agency, while maintaining health and safety
requirements. As such, this proposed action is not expected to cause
any significant adverse economic impacts if implemented as proposed.
This proposed action would only potentially affect Federal, State, or
Territorial government agencies that can petition EPA for an emergency
use authorization under FIFRA section 18. It would therefore have no
direct impacts on local governments, small entities, pesticide
producers or on government entities that may be registrants of
pesticide products, and would have no direct impacts on any other
sector of the economy.
The only significant impacts expected would be burden reductions to
States and Federal agencies in the application process for emergency
exemptions, and to EPA in the review process, as well as quicker
responses to emergency conditions. As detailed in the economic analysis
prepared for this proposed rule, based on predicted future applications
affected by the proposed revisions, EPA estimates the annual combined
savings for applicants and EPA of around $0.94 million, a little over
$0.6 million from re-certification, and about $0.33 million from
changing to the loss-based method of determining significant economic loss.
B. Paperwork Reduction Act
This action does not impose any new information collection burden
that would require additional approval by OMB under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq. This proposed rule is
expected to reduce the existing burden that is approved under OMB
Control No. 2070-0032 (EPA ICR No. 596), which covers the information
collection activities contained in the existing regulations at 40 CFR
part 166, and under the pilot program announced April 23, 2003 (68 FR
20145). A copy of the OMB approved Information Collection Request (ICR)
has been placed in the public docket for this rulemaking, and the
Agency's estimated burden reduction is presented in the economic
analysis that has been prepared for this proposed rule.
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
An agency may not conduct or sponsor, and a person is not required
to respond to an information collection request unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR, after appearing in the preamble of the final
rule, are listed in
[[Page 53877]]
40 CFR part 9 and included on any related collection instrument (e.g.,
form or survey).
Submit any comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, including the use of automated
collection techniques, along with your comments on the proposed rule.
The Agency will consider any comments related to the information
collection requirements contained in this proposed rule as it develops
a final rule. Any changes to the burden estimate for the ICR will be
effectuated with the final rule.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., the Agency hereby certifies that this proposed
rule will not have a significant adverse economic impact on a
substantial number of small entities. This action will only directly
impact State and Federal agencies, neither of which qualify as a small
entity under the RFA. This proposed rule does not have any direct
adverse impacts on small businesses, small non-profit organizations, or
small local governments. Section 18 only applies to Federal and State
governments.
D. Unfunded Mandates Reform Act
Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4), EPA has determined that this action does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. This proposed rule only
applies to Federal and State government agencies, the only entities
that can petition the EPA under FIFRA section 18. As described in Unit
IX.A., this proposed rule is expected to result in an overall reduction
of existing costs for applicants and EPA of around $0.94 million. As
such, this action will not impact local or tribal governments or the
private sector, and will not significantly or uniquely affect small
governments. Accordingly, this rule is not subject to the requirements
of sections 202, 203, 204, and 205 of UMRA.
E. Executive Order 13132
Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this proposed rule
does not have ``federalism implications,'' because it will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in the Order. As indicated above, this proposed rule is
expected to reduce burden on Federal and State government agencies that
petition EPA under FIFRA section 18, and on EPA in processing the
applications. Thus, Executive Order 13132 does not apply to this
proposed rule. In the spirit of the Order, and consistent with EPA
policy to promote communications between the Agency and State
governments, EPA has specifically solicited comment from State officials.
F. Executive Order 13175
As required by Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (59 FR 22951, November 6,
2000), EPA has determined that this proposed rule does not have tribal
implications because it will not have any affect on tribal governments,
on the relationship between the Federal government and the Indian
tribes, or on the distribution of power and responsibilities between
the Federal government and Indian tribes, as specified in the Order. As
indicated above, this proposed rule only applies to State and Federal
government agencies. FIFRA section 18 does not apply to tribal
governments. Thus, Executive Order 13175 does not apply to this
proposed rule.
G. Executive Order 13211
This proposed rule is not subject to Executive Order 13211, Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) because it is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866 (see Unit XI.A.), nor is it likely to
have any significant adverse effect on the supply, distribution, or use
of energy.
H. Executive Order 13045
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997) does not apply to this proposed rule because this action is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866 (see Unit XI.A.), nor does it
establish an environmental standard, or otherwise have a
disproportionate effect on children.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), (15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, and sampling procedures) that are developed or adopted by
voluntary consensus standards bodies. This proposed rule does not
impose any technical standards that would require EPA to consider any
voluntary consensus standards.
J. Executive Order 12898
This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities. Therefore, under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994), the Agency has
not considered environmental justice-related issues.
List of Subjects in 40 CFR Part 166
Environmental protection, Emergency exemptions, Pesticides and pests.
Dated: August 25, 2004.
Michael O. Leavitt,
Administrator.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
PART 166--[AMENDED]
1. The authority citation for part 166 would continue to read as
follows:
Authority: 7 U.S.C. 136-136y.
2. Section 166.2 is amended by revising paragraph (b) to read as
follows:
Sec. 166.2 Types of exemptions.
* * * * *
(b) Quarantine exemption. A quarantine exemption may be authorized
in an emergency condition to control the introduction or spread of any
pest that is an invasive species, or is otherwise new to or not
theretofore known to be widely prevalent or distributed within and
throughout the United States and its territories.
* * * * *
3. Section 166.3 is amended by revising paragraphs (a), (d)(3)(i),
(e), (h), and adding paragraphs (k) and (l) to read as follows:
[[Page 53878]]
Sec. 166.3 Definitions.
* * * * *
(a) The term the Act means the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended, 7 U.S.C. 136 et seq.
* * * * *
(d) * * *
(3) * * *
(i) Involves the introduction or dissemination of an invasive
species or a pest new to or not theretofore known to be widely
prevalent or distributed within or throughout the United States and its
territories; or
* * * * *
(e) The term first food use refers to the use of a pesticide on a
food or in a manner which otherwise would be expected to result in
residues in a food, if no tolerance or exemption from the requirement
of a tolerance for residues of the pesticide on any food has been
established for the pesticide under section 408(b)(2) and (c)(2) of the
Federal Food, Drug, and Cosmetic Act.
* * * * *
(h) The term significant economic loss means that, compared to the
situation without the pest emergency and despite the best efforts of
the affected persons, the emergency conditions at the specific use site
identified in the application are reasonably expected to cause losses
meeting any of the following criteria:
(1) For pest activity that primarily affects the current crop, one
or more of the following:
(i) Crop yield loss greater than or equal to 20%;
(ii) Economic loss, including revenue losses and cost increases,
greater than or equal to 20% of gross revenues;
(iii) Economic loss, including revenue losses and cost increases,
greater than or equal to 50% of net revenues;
(2) For all other pest activity, substantial loss or impairment of
capital assets, or a loss that would affect the long-term financial
viability expected from the productive activity.
* * * * *
(k) The term invasive species means, with respect to a particular
ecosystem, any species that is not native to that ecosystem, and whose
introduction does or is likely to cause economic or environmental harm
or harm to human health.
(l) The term IR-4 program refers to the Interregional Research
Project No. 4, which is a cooperative effort of the state land grant
universities, the U.S. Department of Agriculture (USDA) and EPA, to
address the chronic shortage of pest control options for minor crops,
which are generally of too small an acreage to provide economic
incentive for registration by the crop protection industry.
4. Section 166.20 is amended by revising paragraphs (a)(2)(i)(A),
(a)(3), (a)(9), (b)(4), and adding paragraph (b)(5) to read as follows:
Sec. 166.20 Application for a specific, quarantine, or public health
exemption.
(a) * * *
(2) * * *
(i) * * *
(A) A copy of the label(s) if a specific product(s) is/are
requested; or the formulation(s) requested if a specific product is not
desired; and
* * * * *
(3) Desciption of the proposed use. The application shall identify
all of the following:
(i) Sites to be treated, including their locations within the State;
(ii) The method of application;
(iii) The rate of application in terms of active ingredient and product;
(iv) The maximum number of applications;
(v) The total acreage or other appropriate unit proposed to be treated;
(vi) The total amount of pesticide proposed to be used in terms of
both active ingredient and product;
(vii) All applicable restrictions and requirements concerning the
proposed use which may not appear on labeling;
(viii) The duration of the proposed use; and
(ix) Earliest possible harvest dates.
* * * * *
(9) Acknowledgment by registrant. The application shall contain a
statement by the registrants of all pesticide products proposed for use
acknowledging that a request has been made to the Agency for use of the
pesticide under this section. This acknowledgment shall include a
statement of support for the requested use, including the expected
availability of adequate quantities of the requested product under the
use scenario proposed by the applicant(s); and the status of the
registration in regard to the requested use including appropriate
petition numbers, or of the registrant's intentions regarding the
registration of the use.
* * * * *
(b) * * *
(4) A discussion of the anticipated significant economic loss,
together with data and other information supporting the discussion,
that addresses one or more of the following, as appropriate:
(i) Crop yield or utilized yield reasonably anticipated in the
absence of the emergency and expected losses in quantity due to the
emergency;
(ii) The information in paragraph (b)(4)(i) of this section plus
prices reasonably anticipated in the absence of the emergency and
changes in prices and/or production costs due to the emergency;
(iii) The information in paragraph (b)(4)(ii) of this section plus
operating costs reasonably anticipated in the absence of the emergency;
(iv) Any other information explaining the economic consequences of
the emergency.
(5) Re-certification of an emergency condition. Applicants for
specific exemptions for which the emergency condition could reasonably
be expected to continue for longer than 1 year, and for which the
exemption was granted for the same pesticide at the same site to the
same applicant the previous year, but no more than twice, may submit
less information by basing such application on previously submitted
information. For applications for such exemptions, except for
applications subject to public notice pursuant to Sec. 166.24(a)(1)
through (a)(5), the information requirements of paragraphs (a)(1)
through (a)(10) of this section, and of paragraphs (b)(1) through
(b)(4) of this section, shall not apply where the applicant certifies
that all of the following are true:
(i) The emergency condition described in the preceding year's
application continues to exist;
(ii) Except as expressly identified, all information submitted in
the preceding year's application is still accurate;
(iii) Except as expressly identified, the proposed conditions of
use are identical to the conditions of use EPA approved for the
preceding year;
(iv) Any conditions or limitations on the eligibility for re-
certification identified in the preceding year's notice of approval of
the emergency exemption have been satisfied.
* * * * *
5. Section 166.24 is amended by revising the introductory text of
paragraph (a) and (a)(6)(i) to read as follows:
Sec. 166.24 Public notice of receipt of application and opportunity
for public comment.
(a) Publication requirement. The Administrator shall issue a notice
of receipt in the Federal Register for a specific, quarantine, or
public health exemption and request public comment when any one of the
following criteria is met:
* * * * *
(6) * * *
(i) An emergency exemption has been requested or approved for that
use in
[[Page 53879]]
any 3 previous years, or any 5 previous years if the use is supported
by the IR-4 program, and
* * * * *
6. Section 166.25 is amended by revising paragraphs (a)(2), (a)(4),
and (b)(2)(ii) to read as follows:
Sec. 166.25 Agency review.
(a) * * *
(2) The Agency's ability and intention to establish a time-limited
tolerance(s) or exemption(s) from the requirement of a tolerance for
any pesticide residues resulting from the authorized use, identifying
the level of permissible residues in or on food or feed resulting from
the proposed use;
* * * * *
(4) The potential risks to human health, endangered or threatened
species, beneficial organisms, and the environment from the proposed use.
(b) * * *
(2) * * *
(ii) The progress which has been made toward registration of the
proposed use, if a repeated specific or public health exemption is
sought. It shall be presumed that if a complete application for
registration of a use, which has been under a specific or public health
exemption for any 3 previous years, or any 5 previous years if the use
is supported for registration by the IR-4 program, has not been
submitted, reasonable progress towards registration has not been made.
7. Section 166.30 is amended by revising paragraph (a)(1), removing
paragraph (b), and redesignating existing paragraph (c) as paragraph (b).
Sec. 166.30 Notice of Agency decision.
(a) * * *
(1) Incomplete applications. The Agency may discontinue the
processing of any application that does not address all of the
requirements of Sec. 166.20 until such time the additional information
is submitted by the applicant.
* * * * *
8. Section 166.32 is amended by revising the introductory text of
paragraph (b) to read as follows:
Sec. 166.32 Reporting and recordkeeping requirements for specific,
quarantine, and public health exemptions.
* * * * *
(b) Interim and final reports. A final report summarizing the
results of pesticide use under any specific, quarantine, or public
health exemption must be submitted to the Agency within 6 months from
the expiration of the exemption unless otherwise specified by the
Agency. For quarantine exemptions granted for longer than 1 year,
interim reports must be submitted annually. When an application for
renewal of the exemption is submitted before the expiration of the
exemption or before submission of the final report, an interim report
must be submitted with the application. The information in interim and
final reports shall include all of the following:
* * * * *
9. Section 166.40 is amended by revising paragraph (a), removing
the period at the end of paragraph (b) and adding a semi-colon and the
word ``and'' at the end of paragraph (b), and adding paragraph (c) to
read as follows:
Sec. 166.40 Authorization.
* * * * *
(a) An unpredictable emergency condition exists;
* * * * *
(c) EPA has provided verbal confirmation that, for food uses, a
tolerance or exemption from the requirement of a tolerance can be
established in a timely manner, responsive to the projected timeframe
of use of the chemical and harvest of the commodity, and that, for any
use, the Agency has no other risk-based objection.
10. Section 166.43 is amended by revising paragraphs (a)(1) and (b)
to read as follows:
Sec. 166.43 Notice to EPA and registrants or basic manufacturers.
(a) * * * (1) The State or Federal Agency issuing the crisis
exemption must notify the Administrator, and receive verbal
confirmation from EPA required in Sec. 166.40(c), in advance of
utilization of the crisis provisions. EPA will attempt to provide such
confirmation as quickly as possible, but shall notify the applicant of
its determination within 36 hours.
* * * * *
(b) Contents of notice. Information required to be provided in
notices shall include all of the following:
(1) The name of the product and active ingredient authorized for
use, along with the common name and CAS number if available, including
a copy of the EPA registered label and use directions appropriate to
the authorized use;
(2) The site on which the pesticide is to be used or is being used;
(3) The use pattern;
(4) The date on which the pesticide use is to begin and the date
when the use will end;
(5) An estimate of the level of residues of the pesticide expected
to result from use under the crisis exemption;
(6) Earliest anticipated harvest date of the treated commodity;
(7) Description of the emergency situation; and
(8) Any other pertinent information available at the time.
Sec. 166.47--[Removed]
11. Section 166.47 is removed.
12. Section 166.49 is amended by revising paragraph (a) to read as
follows:
Sec. 166.49 Public notice of crisis exemptions.
(a) Periodic notices. At least quarterly, the Administrator shall
issue a notice in the Federal Register announcing issuance of crisis
exemptions. The notice shall contain all of the following:
(1) The name of the applicant;
(2) The pesticide authorized for use;
(3) The crop or site to be treated; and
(4) The name, address, and telephone number of a person in the
Agency who can provide further information.
* * * * *
[FR Doc. 04-20038 Filed 9-2-04; 8:45 am]
BILLING CODE 6560-50-S