[Federal Register: January 24, 2003 (Volume 68, Number 16)]
[Proposed Rules]
[Page 3785-3795]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja03-39]
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Part IX
Department of Commerce
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National Oceanic and Atmospheric Administration
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50 CFR Part 402
Department of the Interior
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Fish and Wildlife Service
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50 CFR Part 402
Environmental Protection Agency
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40 CFR Chapter I
Endangered Species and Pesticide Regulation; Proposed Rules
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 402
RIN 0648-AQ69
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 402
RIN 1018-AI95
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Chapter I
[OPP-2003-0010; FRL-7287-3]
RIN 2070-AD72
Endangered Species and Pesticide Regulation
AGENCIES: Fish and Wildlife Service, Interior; National Marine
Fisheries Service, National Oceanic and Atmospheric Administration,
Commerce; and Environmental Protection Agency.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: This Advance Notice of Proposed Rulemaking (ANPR) announces
the intention of the Fish and Wildlife Service (FWS), a bureau of the
Department of the Interior, and the National Marine Fisheries Service
(NMFS), an Agency of the National Oceanic and Atmospheric
Administration (NOAA), jointly referred to as ``the Services,'' in
cooperation with the U.S. Environmental Protection Agency (EPA), to
conduct rulemaking to promulgate ``counterpart regulations'' under the
Endangered Species Act (ESA). Specifically, this ANPR focuses on
regulations and policies affecting the process for consultation between
EPA and the Services regarding EPA actions in its pesticide regulatory
program under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and does not address processes among the Services and any other
office within EPA. Throughout this rulemaking process, the Services and
EPA will work with the U.S. Department of Agriculture (USDA) to
implement the purposes of ESA and to effectuate the intent of the
Congress that ESA compliance for EPA's FIFRA program be designed to
``minimize the impacts to persons engaged in agricultural food and
fiber commodity production and other affected pesticide users and
applicators.'' This ANPR also seeks public comment on possible
approaches to changing the current regulations, policies, and practices
of EPA and the Services to better integrate the FIFRA and ESA processes
and to improve the efficiency and effectiveness of consultations on
pesticide actions to enhance protection of species that are Federally
listed or proposed as threatened or endangered and their proposed or
designated critical habitat. The agencies are specifically requesting
comments that focus on developing solutions to the extremely complex
issues surrounding these consultations. In addition, this ANPR seeks
comment on ways to improve public involvement and understanding of
these processes and the decisions that result from them.
DATES: Comments, identified by docket ID number OPP-2003-0010, must be
received on or before March 10, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: For FWS: Richard E. Sayers, Jr.,
Endangered Species Program, U.S. Fish and Wildlife Service, ARL SQ42,
1849 C St., NW., Washington, DC 20240; telephone number: (703) 358-
2106; fax number: (703) 358-1735; e-mail address: Rick_Sayers@fws.gov.
For NOAA: Laurie Allen, Office of Protected Resources, National
Marine Fisheries Service, National Oceanic and Atmospheric
Administration, 1315 East-West Highway, Rm. 13821, Silver Spring, MD;
telephone number: (301) 713-2322, fax number: (301) 713-0376; e-mail
address: Laurie.Allen@noaa.gov.
For EPA: Arthur-Jean Williams, Field and External Affairs Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5239; fax number: (703) 308-3259; e-mail address:
williams.arty@epa.gov.
SUPPLEMENTARY INFORMATION: This ANPR is organized into four Units. Unit
I. contains ``General Information'' about the applicability of this
ANPR, how to obtain additional information, how to submit comments in
response to the request for comments, and certain other related
matters. Unit II. provides background information on the pesticide
regulatory program and the process by which Federal agencies consult or
confer with the FWS and NMFS to ensure appropriate protection of
Federally listed and proposed, threatened and endangered species
(``listed species'') and their proposed and designated critical habitat
(``critical habitat''). It also explains why EPA and the Services are
considering changing the current approach to consultation for EPA's
pesticide regulatory program and the goals of any future changes. Unit
III. of the ANPR identifies specific aspects of the existing
consultation process followed by EPA and the Services and seeks public
comment on how these aspects might be modified to improve the
consultation process for EPA's pesticide regulatory program. Finally,
Unit IV. discusses regulatory assessment requirements.
I. General Information
While this ANPR is being issued jointly by EPA and the Services,
because EPA has an electronic docket system that allows distribution of
materials more easily to interested persons, EPA has agreed to take
responsibility for all of the administrative duties related to
publication of this document, including the creation of a public
docket, receipt of public comments, and other related matters. EPA will
share all comments it receives with the Services, and all three
agencies will work together to compile and analyze public comments and
on any future steps.
A. Does this Action Apply to Me?
This action is directed to the public in general and may be of
particular interest to persons who manufacture, sell or use pesticides
or who are part of a State or Tribe engaged in the regulation of
pesticide products and to groups interested in environmental
regulation. The Agency and the Services have not attempted to describe
all the specific entities that may be affected by this action. If you
have any questions regarding the applicability of this action to a
particular entity, consult Arthur-Jean Williams at the telephone
number/e-mail address listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0010. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is
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restricted by statute. The official public docket is the collection of
materials that is available for public viewing at the Public
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA and the Services are not
required to consider these late comments. If you wish to submit CBI or
information that is otherwise protected by statute, please follow the
instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit
CBI or information protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2003-0010. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2003-0010. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB), Office of Pesticide Programs (OPP),
Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0010.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2003-0010. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.A.1.
D. How Should I Submit CBI to EPA?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that
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information as CBI (if you submit CBI on disk or CD ROM, mark the
outside of the disk or CD ROM as CBI and then identify electronically
within the disk or CD ROM the specific information that is CBI).
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
ID number in the subject line on the first page of your response. It
would also be helpful if you provided the name, date, and Federal
Register citation related to your comments.
II. Background
A. What Action are the Agencies Taking?
The Fish and Wildlife Service (FWS) of the Department of the
Interior and the National Marine Fisheries Service (NMFS) of the
National Oceanic and Atmospheric Administration (NOAA), together with
the Environmental Protection Agency (EPA), announce their intent to
conduct rulemaking to make changes in the way that EPA consults with
FWS and NMFS (jointly referred to as ``the Services'') under the
Endangered Species Act (ESA) on regulatory actions involving
pesticides, under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). The Services and EPA are issuing this ANPR, in
consultation with the U.S. Department of Agriculture (USDA), to solicit
public comment on a range of possible changes that are intended to
better integrate the consultation process under section 7 of ESA with
the process for pesticide regulatory actions taken by EPA under FIFRA,
and to improve the efficiency and effectiveness of consultation on
pesticide actions. Some of the possible changes would require
modification of the Services' existing consultation regulations in 50
CFR part 402; a rule modifying the consultation regulations for a
specific Federal agency is called a ``counterpart regulation.'' See 50
CFR 402.04. Other possible changes in the current approach to
consultations between EPA and the Services could be accomplished
without rulemaking, for example through a Memorandum of Understanding
or changes in policies and practices at EPA or the Services.
EPA and the Services are currently engaged in a number of separate,
but related activities relative to EPA's responsibilities under ESA, in
addition to the publication of this ANPR. First, under ESA section
7(a)(1), EPA and the Services are engaged in an ongoing Proactive
Conservation Review. This review of EPA's Endangered Species Protection
Program (ESPP) is intended to clarify for the involved Federal agencies
EPA's approach to risk assessment, criteria that indicate a listed
species may be at risk, and the requirements imposed on EPA by the ESA
regulations governing consultation. The review will also identify areas
or issues relative to risk assessment, criteria, and consultations that
may require modification to enhance the effectiveness and efficiency of
consultation among EPA and the Services. While this review is conducted
under ESA section 7(a)(1), the outcomes of the review will likely be
used to help focus discussions on technical and science policy issues
that need to be addressed to carry out responsibilities under ESA
section 7(a)(2) more effectively and efficiently. Second, on December
2, 2002, EPA published a Notice in the Federal Register (67 FR 71549)
(FRL-7283-7) describing and requesting comments on implementation of
its ESPP. The goal of the ESPP is to carry out EPA's responsibilities
under FIFRA in compliance with ESA, while at the same time not placing
unnecessary burden on agriculture and other pesticide users.
Although this ANPR contemplates significant revisions to the
Services' ESA regulations as they relate to EPA's pesticide regulatory
programs under FIFRA, EPA will continue to address its ESA section
7(a)(2) obligations regarding pesticide actions under existing Service
rules until such time as the changes contemplated by this ANPR are
finalized. While EPA and the Services believe these revisions can
greatly improve the efficiency and effectiveness of the consultation
process, all three agencies believe that the work they will be doing
under the existing regulations during this interim period will ensure
that endangered species are protected as required by law.
EPA and the Services believe it is also important that the public
and pesticide registrants and users understand that EPA has significant
authority under FIFRA to protect endangered species and their habitats
from potentially harmful exposure to pesticides, and that FIFRA
provides EPA the exclusive statutory authority for modifying a
pesticide registration. Accordingly, when regulatory action is
determined to be appropriate to protect listed species or their
habitat, EPA will use the authority and procedures set forth in FIFRA
to undertake such action.
B. What are the Agencies' Authorities for Taking this Action?
This ANPR is issued under the authority of section 7 of the
Endangered Species Act (ESA), as amended, 16 U.S.C. 1531 et seq., and
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7
U.S.C. 136 et seq. EPA's statutory authority and programs for
regulating pesticides are discussed in Unit II.C., while Unit II.D.,
describes the applicable provisions of ESA and implementing
regulations.
C. FIFRA and Pesticide Regulation
FIFRA is the primary statute under which EPA regulates the use of
pesticides in the United States. 7 U.S.C. 136 et seq. FIFRA defines a
``pesticide'' as ``. . . any substance or mixture of substances
intended for preventing, destroying, repelling, or mitigating any pest
. . . .'' FIFRA sec. 2(u). When a pesticide is sold or distributed, it
is generally referred to as a ``pesticide product.'' Pesticides contain
both ``active ingredients'' and ``inert ingredients.'' An ``active
ingredient'' is ``. . . an ingredient which will prevent, destroy,
repel, or mitigate any pest . . . .'' FIFRA sec. 2(a). Ingredients
which are not active are referred to as
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``inert ingredients'' or ``other ingredients.'' Under FIFRA, an
``inert ingredient'' is defined as ``an ingredient which is not
active.'' FIFRA sec. 2(m). EPA uses the term, ``formulation,'' to refer
to the particular combination of active and inert ingredients in a
pesticide product. A pesticide ``use'' refers to the particular
combination of circumstances under which a pesticide product may be
applied, such as the rate, timing, method, and site of application.
1. The statutory framework for regulation of new pesticide
products. FIFRA generally prohibits the sale or distribution of a
pesticide product unless it has first been ``registered'' by EPA. FIFRA
sec. 12(a)(1)(A). EPA issues a license, referred to as a
``registration,'' for each specific pesticide product allowed to be
marketed; the registration approves sale of a product with a specific
formulation, in a specific type of package, and with specific product
labeling for a specific use. Each product is evaluated on a case-by-
case basis.
FIFRA requires a person seeking to register a pesticide to
demonstrate that the proposed product meets the statutory standard. EPA
may approve the unconditional registration of a pesticide product only
if the Agency determines, among other things, that use of the pesticide
would not cause ``unreasonable adverse effects on the environment.''
FIFRA sec. 3(c)(5). The statute defines ``unreasonable adverse effects
on the environment'' to include ``any unreasonable risk to man or the
environment, taking into account the economic, social, and
environmental costs and benefits of the use of any pesticide. . . .''
FIFRA sec. 2(bb).
When EPA registers a pesticide, it approves among other things a
specific set of labeling for the product which contains directions for
and restrictions on use of the product. Labeling includes any written
or graphic material attached to the product container, i.e., the label,
as well as other material accompanying the product or referenced on the
label. FIFRA sec. 2(p). FIFRA makes it unlawful for any person ``to use
any registered pesticide in a manner inconsistent with its labeling.''
FIFRA sec. 12(a)(2)(G). Thus, directions and restrictions appearing on,
or referenced in, a pesticide product label become enforceable Federal
requirements. Under FIFRA, most States have primary responsibility for
enforcement against pesticide misuse. See FIFRA sec. 26.
While most regulatory decisions allowing entry of new pesticide
products into the marketplace are made by EPA in its registration
program, there are two other programs that can authorize the use of new
pesticides. Under section 18 of FIFRA, EPA may allow the use of an
unregistered pesticide product by a State or Federal agency when
necessary to address an emergency situation. Under EPA's regulations, a
petition for an exemption must establish that ``emergency conditions''
-- defined as ``an urgent, non-routine situation that requires the use
of a pesticide . . .'' -- exist and that no effective, currently
registered pesticide or non-pesticidal pest control method is
available. 40 CFR 166.4(d). The emergency exemption regulations provide
that EPA will not approve a request unless EPA determines, among other
things, the use of the pesticide product will not cause unreasonable
adverse effects on the environment. 40 CFR 166.25(b). In addition,
under certain limited circumstances, States may approve a new use of a
currently registered pesticide product to meet a ``special local
need.'' FIFRA sec. 24(c). EPA's regulations limit States' exercise of
this authority only to the approval of products that contain active
ingredients that are present in a currently approved pesticide product
and give EPA broad authority to disapprove products intended for uses
that are not closely related to existing uses. See 40 CFR 162.152.
States must notify EPA when they exercise this authority and a State's
registration shall not be effective for more than 90 days if
disapproved by EPA within that period. FIFRA sec. 24(c)(2).
2. The statutory framework for regulation of existing pesticide
products. In addition to a registration program for new pesticide
products, EPA conducts a ``reregistration'' program. Reregistration
focuses on currently registered pesticides and involves a systematic
reexamination of the scientific data to determine whether the
pesticides continue to meet contemporary scientific and regulatory
standards. See FIFRA sec. 4. Among other things, EPA assesses whether
there are adequate data to determine if the statutory standard is met.
FIFRA gives EPA authority to require registrants to provide data if EPA
``determines [the] additional data are required to maintain in effect
an existing registration of a pesticide.'' FIFRA sec. 3(c)(2)(B).
(Imposition of such additional data requirements is subject to the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 - 3520). In
the past, EPA has used this authority to require registrants to conduct
studies that would provide additional data needed for the evaluation of
potential hazards of and exposures to pesticide products. EPA uses such
data to assess pesticide risks and to determine whether changes in the
terms and conditions of registration would be appropriate. In many
cases, EPA's reregistration review has concluded that additional risk
mitigation measures were necessary to reduce potential harm to non-
target plants and wildlife populations. Many registrants voluntarily
have amended their products' registrations to implement these risk
mitigation measures. If, however, registrants do not adopt needed risk
mitigation, EPA may impose the requirements through cancellation or
suspension proceedings, conducted pursuant to FIFRA sec. 6 and 40 CFR
part 164.
EPA may issue a Notice of Intent to Cancel the registration of a
pesticide if it appears that the continued use of the pesticide
``generally causes unreasonable adverse effects on the environment.''
FIFRA sec. 6(b). Thus, the standard for approving a pesticide's entry
into the marketplace and the standard for retaining a pesticide on the
market is based on a determination relative to ``no unreasonable
adverse effects'' Because cancellation proceedings can be lengthy,
FIFRA also contains provisions allowing EPA to ``suspend'' the
registration and use of a pesticide, prior to the completion of a
cancellation process, if use of the pesticide poses an ``imminent
hazard.'' FIFRA sec. 6(c). FIFRA defines an ``imminent hazard'' as ``a
situation which exists when the continued use of a pesticide during the
time required for [a] cancellation proceeding would be likely to result
in unreasonable adverse effects on the environment or will involve
unreasonable hazard to the survival of a species declared endangered or
threatened under [the Endangered Species Act].'' FIFRA sec. 2(l).
3. Ecological risk assessment. In deciding whether a pesticide
product meets the statutory standards for registration or
reregistration, EPA considers, among other things, the potential risks
to non-target wildlife and plant species posed by use of the pesticide
product. EPA's evaluation of such environmental risks follows the
principles contained in its Guidelines for Ecological Risk Assessment.
(EPA 1998). In 1986, EPA developed detailed guidance for the review and
analysis of potential environmental risks from use of pesticide
products. See Standard Evaluation Procedures (SEP) for Ecological Risk
Assessment (EPA 1986). Since 1986 EPA has made many additions and
refinements to the basic approach outlined in the SEP. All of
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EPA's risk assessment methods have included methodology for an
assessment of potential risks to listed species. Refer to the ESPP
Federal Register Notice (67 FR 71549) for a more detailed description
of how EPA assesses the risk to listed species.
EPA requires both new and existing pesticides to be supported by
extensive information about the potential ecological risks of the
pesticide product. Data requirements appear in EPA regulations at 40
CFR part 158. Studies conducted to generate data for EPA are subject to
Good Laboratory Practice requirements that are designed to ensure that
the results are reliable and of high quality. See 40 CFR part 160.
EPA's scientists carefully review all data submissions and
independently evaluate the potential risks of each pesticide. In
situations raising novel or challenging scientific issues, EPA
generally seeks outside peer review of its scientific assessments.
The Agency requires extensive toxicity and environmental fate data
and uses this information, together with field reports of adverse
effects on wildlife caused by pesticides and other relevant
information, to evaluate the potential hazards to non-target species,
including threatened and endangered species, for a pesticide intended
for outdoor use. To assess potential hazard to non-target species, EPA
requires a basic set of laboratory toxicity studies on an active
ingredient using multiple surrogate species of birds, fish, aquatic
invertebrates, non-target insects, and plants. In situations where
additional, scientifically valid, toxicity data related to effects on
wildlife and aquatic organisms are available, EPA will consider them in
establishing the toxicity endpoint for risk assessment. It is EPA's
policy to conduct risk assessments using the toxicity endpoint from the
most sensitive species tested. EPA also requires data from a series of
laboratory and field studies of the environmental fate of both the
active ingredients in a pesticide product and typical formulations
containing the active ingredient. These studies provide data on both
the parent active ingredient, as well as its environmental degradates.
The Agency combines these data, along with information about how the
pesticide product is intended to be used, to develop an estimate of the
potential concentrations of residues of the active ingredient and
significant environmental degradates in the environment (the Estimated
Environmental Concentration or EEC). In order to avoid underestimating
risk, EPA makes assumptions designed not to understate potential
exposure.
When assessing risks to listed species, EPA evaluates data and
risks in a tiered fashion. The Agency compares its toxicity assessment
of an active ingredient with the EEC. If the comparison demonstrates
that the EEC is well below the amount of active ingredient that would
be expected to cause harm to a particular species or critical habitat,
EPA would conclude that the use of pesticide products containing that
active ingredient would have ``no effect'' on listed species. Most of
EPA's focus is on the potential risks from exposure to the active
ingredient and its significant environmental degradates. EPA also has
information, both on the other ingredients in pesticide products and on
the formulations themselves, with which to assess the potential for
increased risk. This ingredient- and formulation-specific information
and many years of reviewing pesticide products support a general
conclusion that inert ingredients in formulations usually do not make
more than a negligible contribution to the overall environmental risks
posed by a pesticide product formulation. If the initial comparison and
subsequent refined assessments indicate that EPA's best estimate of the
EEC for the active ingredient and/or significant environmental
degradates could have toxic effects on a listed species, then EPA may
require the pesticide sponsor to supply additional laboratory and/or
field data in order to refine the risk assessment, require changes in
the allowable use of the pesticide product that are sufficient to
mitigate any potential risk, or determine it necessary to request
initiation of consultation with the Services to obtain a Biological
Opinion on actions that might be taken relative to reducing risk.
Higher tier toxicity data may include studies on the effects of a
pesticide on other wildlife species and plants or studies of longer
durations of exposure. The Agency may occasionally require higher tier
studies to be conducted in the field under simulated or actual use
conditions. EPA may also require additional information to improve its
estimate of potential exposure. Possible risk mitigation measures
include changes in the manner or timing of pesticide applications, the
rate or frequency of applications, or geographical restrictions on use.
D. The Endangered Species Act and Federal Agency Consultations with the
Services
Section 7 of the ESA imposes obligations upon all Federal agencies
whose actions may adversely impact listed species. Of particular
relevance to this ANPR, section 7(a)(2) directs all Federal agencies,
in consultation with and with the assistance of the Secretaries of the
Interior and Commerce (delegated to the Services), to ensure that any
action authorized, funded, or carried out by such agency is not likely
to jeopardize the continued existence of any listed species or result
in the destruction or adverse modification of habitat of such species
that has been designated as critical (``critical habitat''). 16 U.S.C.
1536(a)(2). In meeting this requirement, each agency is required to use
the ``best scientific and commercial data available.'' 16 U.S.C.
1536(a)(2).
The Services adopted joint regulations set forth at 50 CFR part
402, which include procedural requirements. These regulatory provisions
require action agencies to consult with the Services on all Federal
actions that ``may affect'' a listed species or critical habitat.
Consultation may be concluded ``informally'' if the action agency, with
written concurrence from the Services, determines that the Federal
action under consideration is ``not likely to adversely affect'' a
listed species or critical habitat. 50 CFR 402.14(b)(1). ``Formal''
consultation is required on actions that are likely to adversely affect
a listed species or critical habitat and when the Services disagree
with an action agency's determination that the action is ``not likely
to adversely affect'' the species or its critical habitat. During
formal consultation, focus is on whether the proposed Federal action is
likely to jeopardize the continued existence of any listed species or
result in the destruction or adverse modification of critical habitat.
50 CFR 402.14(h).
By regulation, the consultation process reviews a variety of
potential ``effects'' on listed species and habitat, including direct,
indirect, and cumulative effects. ``Direct effects'' are those effects
that will immediately flow from the proposed action. ``Indirect
effects'' are those that will be caused by the proposed action, will
occur later in time, but are still reasonably certain to occur.
``Cumulative effects'' are those effects of future State or private
activities, not involving Federal activities, that are reasonably
certain to occur within the area affected by the proposed action. 50
CFR 402.02. Additionally, examination includes the effects of
``interrelated'' and ``interdependent'' actions. For a detailed
explanation of these terms, please refer to the Consultation Handbook
jointly published by NMFS and FWS, which further elaborates on the
procedures followed by the Services when conducting section 7
consultations.
[[Page 3791]]
http://endangered.fws.gov/consultations/s7hndbk/s7hndbk.htm.
During formal consultation, focus is upon whether the proposed
Federal action is likely to jeopardize the continued existence of any
listed species or result in the destruction or adverse modification of
critical habitat. 50 CFR 402.14(h).
At the conclusion of formal consultation, the Services will issue a
``biological opinion'' that details the effects of the action on the
listed species or critical habitat, and whether the action is likely to
jeopardize the continued existence of a listed species or result in the
destruction or adverse modification of critical habitat. 16 U.S.C.
1536(b)(3)(A). A ``jeopardy'' biological opinion must include
reasonable and prudent alternatives, if any are available. Where
jeopardy or adverse modification of critical habitat does not exist,
the Services must issue an incidental take statement that specifies
reasonable and prudent measures necessary to minimize incidental
impact. 16 U.S.C. 1536(b)(4). When the terms and conditions of the
incidental take statement are followed, all incidental takings that
occur are not subject to liability. 16 U.S.C. 1536(o).
Service regulations implementing section 7 also authorize the
promulgation of counterpart regulations, that establish alternate
consultation procedures for a particular Federal agency. 50 CFR 402.04.
Authority to promulgate counterpart regulations acknowledges that in
certain instances, the section 7 consultation process can benefit from
procedures that differ from the traditional consultation process
established by the Services. This ANPR contemplates such regulations.
E. EPA's and the Services' Goals for this ANPR
The Services and EPA are seeking ways to better integrate FIFRA
pesticide registration and ESA section 7 consultation processes thereby
making the section 7 consultation on pesticides more effective and
efficient. Additionally, EPA and the Services are seeking to improve
public involvement in and understanding of the consultation process on
FIFRA actions. In order to meet these goals, the Services and EPA, in
consultation with USDA, will propose counterpart regulations governing
section 7 consultation for EPA's regulatory actions, as well as any
changes to the FIFRA policies and practices, which may be necessary. In
addition, EPA and the Services are considering other procedural
modifications to the consultation process for pesticide regulation.
In 1988, Congress addressed the relationship between ESA and EPA's
pesticide labeling program. Public Law 100-478, October 7, 1988,
amended ESA and required EPA to conduct a study, and to provide
Congress with a report of the results, on ways to implement EPA's
endangered species pesticide labeling program in a manner that both
complies with ESA and allows people to continue production of
agricultural food and fiber commodities. Thus, the clear sense of
Congress is that EPA should fulfill its obligation to conserve listed
species, while at the same time considering the needs of agriculture
and other pesticide users. Accordingly, EPA and the Services are
working with USDA in this process.
EPA and the Services share the same overall goal--to improve their
capacity to provide needed protection for listed species and their
critical habitat in an expedited manner that is not unnecessarily
burdensome for pesticide users. The Services and EPA believe that
procedures and policies that result in better integration of the ESA
consultation process with pesticide regulatory programs--both
registration and reregistration--should lead to more efficient
production of scientifically sound assessments of risks to listed
species and critical habitat. That, in turn, should benefit both the
listed species and those affected by EPA's pesticide regulatory
programs. Improving the process, including shortening the time frames
for ESA review of currently registered pesticide products, would enable
EPA to more efficiently implement risk mitigation measures to prevent
jeopardy to listed species and to avoid adversely modifying critical
habitat. Moreover, many of the applications submitted for registration
of pesticide products containing new active ingredients involve
pesticide formulations that could have less impacts than the currently
registered products with which they would compete. Thus, any
improvements in the efficiency and effectiveness of the ESA review
process could similarly benefit listed species, as well as more broadly
provide benefits for human health and the environment. Finally, given
the importance of pesticide use for such essential purposes as
production of food and fiber and disease prevention, EPA and the
Services believe that improved integration of the FIFRA registration/
reregistration and section 7(a)(2) consultation processes, under new
counterpart regulations, modification to the FIFRA processes, or
through other mechanisms, will be achieved in a way that avoids
unnecessary burdens on pesticide users.
In developing a process for conducting future ESA consultations on
FIFRA pesticide regulatory actions, the agencies believe it is
important to recognize that EPA possesses significant resources and
expertise in the field of ecological risk assessment relative to
pesticides, while the Services possess the technical and regulatory
expertise necessary for consistent administration of ESA. Under FIFRA,
EPA makes decisions to allow new or continued use of a pesticide only
after carefully examining extensive data on the potential risks that
use of a pesticide may pose to non-target wildlife species. In
addition, EPA's pesticide regulatory program may require companies to
conduct studies needed for a risk assessment. As a result, EPA
generally has significant scientific information available with which
to evaluate the hazards a pesticide may pose to non-target wildlife.
Further, to perform its responsibilities under FIFRA, EPA must maintain
a sizeable staff of well-qualified scientists with many years of
combined experience in assessing ecological risks. Finally, EPA has
performed pioneering work in certain areas of ecological risk
assessment, such as the development of exposure models and
probabilistic risk assessment techniques.
In addition to its strong scientific data bases and its expertise
in the field of ecological risk assessment, EPA's decisions have
certain relatively unique characteristics. Pesticide products typically
include multiple uses, and can potentially be used in many different
parts of the country. Thus, in evaluating a pesticide, EPA considers
different locations where the product may be used and whether wildlife
or plant species may be affected by such use. This broad scope of
review contrasts with actions by Federal agencies that have a narrower
geographical scope. In addition, the number of pesticide decisions is
also a factor potentially affecting the section 7 consultation process.
In a typical year, EPA will make hundreds of decisions regarding
pesticide registration, some involving very extensive risk assessments,
while others require more limited reviews. For example, in fiscal year
2002, EPA registered 26 new pesticide active ingredients; approved the
addition of 720 new uses of previously registered active ingredients on
close to 1,500 different crops; and completed more than 4,700 more
minor registration actions. EPA also completed reregistration
assessments on 36
[[Page 3792]]
previously registered active ingredients, and processed over 500
emergency exemption requests in FY 2002. Numbers of actions in most of
these categories have risen since FY 2000. The combination of the
number and variety of pesticide regulatory decisions EPA makes each
year, together with the possible use of pesticide products on multiple
sites located in different parts of the country, means that the
potential number of consultations about the effects of EPA actions
could be far greater than result from any other single Federal
regulatory program.
The implementation of a number of the changes discussed in Unit
III. would require modification of the existing consultation
regulations and FIFRA procedures. We are interested in public comment
on all potential changes to the current approach to consultation that
could be put into effect through rulemaking or without rulemaking, such
as through interagency agreements.
III. Request for Comment
This unit of the ANPR invites public comment on a number of ways in
which the current regulations, policies, and practices of the Services
and EPA regarding ESA consultations about decisions in the pesticide
regulatory program could be modified. Unit III.A. focuses on possible
approaches to identifying types of actions that would not require case-
by-case consultation between EPA and the Services. Unit III.B. asks for
comments on possible changes to the existing framework, while retaining
the basic approach of requiring consultation whenever EPA determines
that use of a pesticide ``may affect'' protected species. Unit III.C.
invites public comment on certain other aspects of the operational
relationship between EPA and the Services. The agencies note that the
specific approaches described below do not exhaust all of the possible
changes that might improve the effectiveness and efficiency of the
consultation process. Thus, the agencies invite the public to include
comments on other ways to modify the regulations, policies and
practices of EPA, FWS, or NMFS to achieve our mutual goals.
Finally, the agencies emphasize that they have made no decisions
with respect to pursuing any specific modification discussed below. The
agencies will consider public comments about a particular proposed
change in light of the following factors, among others: The consistency
of the approach with the requirements of ESA and FIFRA; the scientific
soundness of the approach; and the impact of the approach on government
resources, pesticide users, and others.
A. The Scope of EPA's Consultations on FIFRA Actions Under ESA
1. Programmatic consultation. Under existing Service regulations at
50 CFR part 402, the Services and Federal agencies can engage in
consultations that address major national programs. There is potential
to use this authority to develop a ``programmatic'' approach to
consultation on the pesticide registration program. In regulating
pesticides under FIFRA, EPA does not develop overall pesticide
registration and reregistration programs as, for instance, the Forest
Service might develop a forest plan; rather, EPA makes decisions about
new and existing pesticide uses on a case-by-case basis, subject to the
standards of FIFRA described above. While these decisions are made on a
case-by-case basis, in many circumstances these individual registration
decisions share common elements. For example, EPA receives hundreds of
applications per year for so called ``me-too'' pesticide products that
are identical or nearly identical to currently registered pesticides.
In addition, some classes of pesticides that are not identical may
nonetheless share common exposure or toxicological profiles. Even where
pesticides may not share common characteristics, there may be
approaches to risk assessment and risk management that are appropriate
for identifying and addressing risk concerns to listed species across
broad classes of pesticides.
Thus, in circumstances where such commonalities exist, it may be
possible for EPA to satisfy some or all of its ESA section 7(a)(2)
consultation obligations for individual registration actions by
completing what could be described as ``programmatic'' consultations
affecting numerous registration and reregistration actions
simultaneously. In addition, even where such programmatic consultations
are not sufficient to complete the consultation process for certain
individual actions, they may serve to improve the consultation process
on such actions through the standardization of risk assessment
methodologies and alternatives for species protections.
While the Services' current section 7 regulations provide authority
for agencies to consult on a group of related actions in this fashion,
there may be benefits to using counterpart regulations to establish
criteria that would delineate the circumstances under which EPA would
be expected to consult with the Services and the circumstances where
consultation would not be necessary. Such regulations could identify
those practices that EPA would follow to identify and delineate
potential adverse effects on listed species and their habitat, as well
as the data standards for such evaluations. Such regulations could lead
to more efficient use of resources by both the Services and EPA, while
at the same time providing the public with an opportunity to
participate more fully in the process of protecting listed species.
EPA and the Services welcome comments on this approach and
specifically request that commenters consider the following questions
in developing their submissions:
[sbull] What are the administrative and programmatic advantages and
disadvantages of this approach?
[sbull] What elements of EPA's pesticide program are particularly
amenable to programmatic consultation?
[sbull] To what extent, if any, could or should this approach
change the consultation process for specific regulatory actions under
FIFRA?
[sbull] To what extent would it be appropriate to change any of
EPA's data requirements, risk assessment methods, or criteria for
evaluating potential risks to listed species in connection with such a
``programmatic'' consultation?
[sbull] What are the advantages or disadvantages to implementing
this approach through rulemaking?
[sbull] What are the advantages or disadvantages to implementing
this approach under the Services' existing consultation regulations?
[sbull] What would be the appropriate method for addressing issues
associated with incidental take under this approach?
2. Changes to the informal consultation process. As described in
Unit II.D., ESA requires Federal agencies to consult with the Services
in meeting their section 7(a)(2) obligations to ensure that agency
actions are not likely to jeopardize listed species or destroy or
adversely modify any critical habitat of such species. The current
consultation regulations at 50 CFR part 402 provide that in
circumstances where a Federal agency determines that its actions ``may
affect'' a listed species or critical habitat it must engage in
consultation with the Services. In circumstances where an agency
concludes that an action will have ``no effect'' on listed species or
critical habitat, no further consultation is required, and the Federal
agency, under such circumstances, has satisfied its section 7(a)(2)
obligations regarding such action.
[[Page 3793]]
In those circumstances where a Federal agency cannot conclude that
its actions will have ``no effect'' on listed species or critical
habitat, but can conclude that its actions are ``not likely to
adversely affect'' listed species or critical habitat, Service
regulations provide that if the relevant Service concurs in writing on
that determination the agency need not engage in further, (i.e.,
formal) consultation with the Service. 50 CFR 402.13. The concurrence
approach, in these situations, serves as a Service opinion or
interpretation that the agency has satisfied its section 7(a)(2)
obligations regarding such actions.
Under these circumstances the Services have determined, by
regulation, that formal consultation is unnecessary for individual
agency actions in order for Federal agencies to satisfy their section
7(a)(2) obligations. While this regulatory regime currently applies to,
and is generally appropriate for, a wide variety of Federal agency
actions, there may be circumstances where the mission and expertise of
a particular agency, or a particular office within an agency, may lend
itself to the development of alternative or additional informal
processes. EPA's regulation of pesticides may be one such instance. As
explained in Unit II.C., one of EPA's core functions in the regulation
of pesticides under FIFRA is the development of extensive ecological
risk assessments, including an evaluation of the effects that pesticide
use may have on various plant and animal taxa. As a result, EPA may
possess sufficient information and analytical expertise to make
informed determinations as to whether a pesticide is ``not likely to
adversely affect'' a listed species or critical habitat. For this
reason, EPA and the Services think it is appropriate to consider
whether there is a need for either further consultation or Service
concurrence in those situations where EPA determines that use of a
pesticide is ``not likely to adversely affect'' listed species or
critical habitat.
This ANPR therefore seeks comment on whether to pursue, through
counterpart regulations or other mechanisms, either of the two
following potential approaches to conducting consultation on pesticide
regulatory actions: (1) If EPA determines that a pesticide is not
likely to adversely affect listed species or critical habitat, no
further consultation would be required; or (2) where EPA determines
that a pesticide is not likely to adversely affect listed species or
critical habitat, EPA would continue to consult with the Services but
EPA would not need to obtain the written concurrence of the Services to
satisfy its section 7(a)(2) obligations.
EPA and the Services welcome comments on these alternate approaches
and specifically request that commenters consider the following in
developing their submissions:
[sbull] The administrative and programmatic advantages and
disadvantages of these approaches.
[sbull] In connection with such regulations, what, if any, criteria
should the Services establish which, if met, would support one or both
of the approaches.
[sbull] Whether in connection with such regulations it would be
appropriate or necessary to change any of EPA's data requirements, risk
assessment methods, or criteria for evaluating potential risks to
protected species.
[sbull] Whether there are additional changes to the informal
consultation process that may be warranted.
3. Focused review by the Services during consultation. The
immediately preceding alternative explores amendments to the
circumstances under which informal consultation would be necessary.
This alternative considers potential approaches to consultation that
would focus review provided by the Services once formal or informal
consultation had been initiated. It is predicated on the assumption
that in the development of this rulemaking, EPA's practices and
policies would be reviewed and, where necessary revised to ensure that
the data and analyses EPA obtains and uses provide the best available
information on the effects on threatened and endangered species. As
discussed earlier, EPA has extensive information available with which
to assess and mitigate potential risks to listed species and their
critical habitat and EPA has developed considerable expertise in these
areas. Based on this expertise, therefore, in the case of pesticide
regulatory actions, this alternative proposes that the Services would
rely on EPA's assessment of effects. Thus in the case of pesticide
regulatory actions, the Services would rely on EPA's assessment.
When consultation is necessary, an approach would be to provide for
a more focused review of EPA pesticide submissions by the Services.
This approach would provide for a rebuttable presumption regarding the
adequacy of the effects analysis in an EPA request to initiate
consultation. There are many potential standards that could be applied
to determine whether the effects analysis would be deemed adequate (see
50 CFR 402.14(c)). This ANPR identifies three:
[sbull] Whether EPA had considered the most current and best
available scientific, commercial, and technical information on listed
species and their habitat and that the determinations were not
arbitrary and capricious.
[sbull] Whether there was clear and convincing information
warranting a different conclusion as to the effects of the proposed
registration.
[sbull] Whether there is substantial evidence to support EPA's
effects determinations.
EPA and the Services are seeking comments on this approach and
specifically request that commenters consider the following questions
in developing their submissions:
[sbull] What are the administrative and programmatic advantages and
disadvantages of this overall approach?
[sbull] What are the administrative and programmatic advantages and
disadvantages of specific provisions?
[sbull] What are other possible appropriate evidentiary or
procedural provisions?
[sbull] Should the Services establish criteria which, if met, would
justify such an approach?
[sbull] Would it be appropriate to change any of EPA's data
requirements, risk assessment methods, or criteria for evaluating
potential risks to protected species?
B. Modifications of the Existing Framework Under FIFRA and the ESA to
Increase the Effectiveness, Efficiency, and Flexibility of the Existing
Interagency Process
1. Modification of EPA's approach to assessing potential risk to
protected species. EPA routinely receives and evaluates extensive
scientific information on the potential hazards of and exposure to
pesticide active ingredients as part of its registration and
reregistration processes. Unit II.C. contains an overview of this
evaluation process and EPA's ESPP Notice describes the risk assessment
process in more detail. Please comment on whether there is a need to
modify the current assessment process for evaluating the potential
risks to protected species, including whether there should be any
changes to EPA's data requirements, assessment algorithms, or criteria
for judging whether the use of a pesticide poses a potential risk to
listed species.
2. Scope of a consultation. EPA's registration and reregistration
decisions typically involve one or more pesticide products containing a
specific active ingredient. A single pesticide product is generally
registered for use on multiple crop and/or non-crop sites and may be
[[Page 3794]]
applied on any approved site throughout the United States. Thus, a
single registration encompasses multiple separate decisions by EPA. The
ESA currently requires a Federal agency to ensure that its ``actions''
do not jeopardize protected species or adversely modify critical
habitat. The Services' regulations state that ``[a]ny request for
formal consultation may encompass, subject to the approval of the
Director, a number of similar individual actions within a given area or
a segment of a comprehensive plan.'' 50 CFR 402.14(c). Thus, EPA and
the Services have discretion to determine the scope of the regulatory
action subject to both formal and informal consultations. Please
comment on the advantages and disadvantages of using counterpart
regulations or other mechanisms to give EPA and the Services more
flexibility to define the scope of EPA's consultation with respect to a
specific regulatory action. For example, please comment on whether it
would be appropriate to have the ability to define EPA's proposed
action in a way that would limit a consultation on a registration
decision to: A particular geographical area, a particular ingredient in
a pesticide formulation, or a particular use of a pesticide product.
3. The contents of a consultation package. The ESA requires that
``each agency shall use the best scientific and commercial data
available.'' ESA sec. 7(a)(2). The Services' consultation regulations
specify that a written request to initiate formal consultation shall
contain:
(1) A description of the action to be considered;
(2) A description of the specific area that may be affected by
the action;
(3) A description of any listed species or critical habitat that
may be affected by the action;
(4) A description of the manner in which the action may affect
any listed species or critical habitat and an analysis of any
cumulative effects;
(5) Relevant reports, including any environmental impact
statements, environmental assessments, or biological assessments
prepared; and
(6) Any other relevant available information on the action, the
affected listed species, or critical habitat. 50 CFR 402.14(c).
The Services' regulations define ``cumulative effects'' to mean
``those effects of future State or private activities, not involving
Federal activities, that are reasonably certain to occur within the
action area of the Federal action subject to consultation.'' 50 CFR
402.02. The consultation regulations do not establish any requirements
with respect to the content of a request for an informal consultation.
Please comment on:
[sbull] The meaning of the statutory phrase, ``best scientific and
commercial data available,'' with respect to the type of information
EPA should be required to include in a review package.
[sbull] The advantages and disadvantages of issuing counterpart
regulations to modify the existing requirements in 50 CFR 402.14(c).
[sbull] Whether the same requirements apply to review packages
submitted for informal consultation as for formal consultation or
whether informal consultation packages should be subject to any
regulatory requirements since they are informal.
[sbull] Given that most EPA actions involve multiple pesticide uses
that may range from regional to national in scope, what is the most
effective and efficient way to address the concept of ``cumulative
effects'' as defined under the Services regulations at 50 CFR 402.02?
4. The time frame for completing formal and informal consultation
on pesticide regulatory actions. The ESA sets a goal of 135 days for
concluding a formal consultation, but also contains provisions that
allow the action agency and the Services to agree, in certain
circumstances, to extend the deadline for completing the consultation.
See ESA sec. 7(b). Neither ESA nor the Services' consultation
regulations establish a time frame for completion of informal
consultations.
Please comment on the advantages and disadvantages of:
[sbull] Establishing specific time frames for concluding formal
consultations on pesticide regulatory decisions, including the
possibility of a shorter time frame and what action by EPA should
trigger the start of a time period for formal consultation.
[sbull] Establishing specific time frames for concluding informal
consultations on pesticide regulatory actions and what action by EPA
should trigger the start of a time period for informal consultation.
[sbull] Defining specific circumstances under which the time frames
should be extended and what those circumstances might be.
5. Identify and establish procedures for dealing with an
``emergency'' for purposes of emergency consultation and other
expedited review. The Services' consultation regulations contain
provisions allowing consultation to be conducted in an expedited manner
in ``emergency circumstances.'' 50 CFR 402.05. This provision applies
to ``situations involving acts of God, disasters, casualties, national
defense or security emergencies, etc.'' The regulations state that
expedited consultation may be conducted in any manner consistent with
ESA, and that formal consultations ``shall be initiated as soon as
practicable after the emergency is under control.'' Under FIFRA, EPA
may issue exemptions to States or Federal agencies to allow the use of
an unregistered pesticide when ``emergency conditions exist which
require such exemption.'' FIFRA sec. 18.
Please comment on whether these and other types of regulatory
actions taken by EPA's pesticide programs should be considered
``emergencies'' that would justify conducting any required ESA
consultation in an expedited manner. For example, if consultation with
the Services were required, should emergency consultation provisions
apply to:
[sbull] Petitions for emergency exemptions under FIFRA sec. 18?
[sbull] Notifications to EPA of State issuance of ``special local
needs'' registrations under FIFRA sec. 24(c)?
[sbull] Other circumstances giving rise to a need for expedited
review?
Are there any circumstances where no review by the Services is
appropriate, for example, when the action is taken to address a public
health emergency as described in 40 CFR part 166, under FIFRA?
6. Clarify the role of the Services. As discussed in Unit II.D.,
ESA and existing consultation regulations describe the role that the
Services play in providing advice and opinions on the impact of agency
actions on protected species and their critical habitat.
What are the advantages and disadvantages of using counterpart
regulations or other mechanisms to establish additional
responsibilities for the Services, for example, by specifying that the
Services should assist EPA in developing the information base for
consultation or by specifying the types of information that the
Services should provide to EPA? What other responsibilities, if any,
should the Services assume? Should counterpart regulations (or some
other mechanism) establish a process that a Service follows to ensure
that, when different parts of its organization issue Biological
Opinions on the same pesticide and/or species, its Biological Opinions
are consistent? If so, how should that process operate?
7. Clarify the term ``applicant'' and the participation afforded to
applicants. The current consultation regulations define the term
``applicant,'' as a person ``who requires formal approval or
authorization from a Federal agency as a prerequisite to conducting the
action.''
[[Page 3795]]
50 CFR 402.02. The regulations provide that during formal consultation,
an applicant shall have an opportunity to submit information; the
Service will discuss with the Federal Agency and the applicant the
Service's review and evaluation of the action as well as the basis for
any finding in the Biological Opinion and the availability of
reasonable and prudent alternatives (if a jeopardy opinion is to be
issued) and the applicant may request a copy of, and comment upon, any
draft Biological Opinion requested from the Service by the Federal
Agency before it is issued in final form by the Service. 50 CFR 402.14.
Should the role outlined in current regulations for an
``applicant'' be retained in counterpart regulations. If so, how should
it be applied with respect to pesticide regulatory actions and what
procedural rights should such an ``applicant'' have? At what points in
the consultation process should the general public have an opportunity
to participate?
8. Clarify and improve the role of States and Tribes and other
potential non-Federal representatives. The current consultation
regulations state that a Federal agency may designate a non-Federal
representative to prepare biological evaluations and/or to conduct
informal consultation with the Services. 50 CFR 402.08. While the
regulations do not specify who may (or may not) act as a non-Federal
representative, they do indicate that, in some circumstances, an
``applicant'' may be a non-Federal representative.
Please comment on the circumstances, if any, that pesticide
companies could or should be designated as a non-Federal
representative. In addition, please comment on whether, in view of the
role that States and Tribes play in the enforcement of EPA regulatory
decisions under FIFRA, States or Tribes could or should be designated
as non-Federal representatives.
Should any special or additional procedures be established to
provide greater participation of States and Tribes in the consultation
process, either as a non-Federal representative or in another capacity?
9. Fees. A substantial increase in the number or complexity of
consultations between EPA and the Services will require a corresponding
increase in agency resources.
Please comment on whether it would be appropriate to charge fees to
offset the added expenditures that would be necessary to conduct such
consultations. Who should pay such fees, and how should the amount of
any fee be determined?
10. Process for elevating and resolving disagreements between EPA
and the Services. Neither ESA nor the current consultation regulations
prescribe how an action agency and the Services will resolve
disagreements arising under ESA. EPA and the Services, however, have
addressed this issue with respect to consultations about two of EPA's
regulatory programs involving water. See Memorandum of Agreement, 66 FR
11202, February 22, 2001.
Please comment on the advantages and disadvantages to using
counterpart regulations or some other mechanism to establish procedures
for expedited resolution of disagreements between the Services and EPA.
C. Other Programmatic Aspects of the Consultation Process
EPA's ESPP Notice has invited public comment on the most
appropriate approach to structure consultations about the potential
impacts of pesticides on listed species. The ESPP Notice identified
several possible approaches: Consultation on a pesticide-by-pesticide
basis; on a geographically defined site-by-site basis; on a crop-by-
crop basis; or a species-by-species basis. See 67 FR 71549, December 2,
2002.
In addition to issues about the structure of consultations, EPA and
the Services are interested in issues relating to establishing
priorities for such consultations. In view of the scope of the
pesticide regulatory program, EPA and the Services think the number of
consultations that may be needed in the foreseeable future could
involve substantial resources. Moreover, given the number of pesticides
and their potentially widespread and overlapping uses, the agencies
foresee that there could be a large degree of potentially redundant
effort unless the consultation process is carefully managed to achieve
the most efficient use of limited resources. The Services and EPA
therefore invite comment on any additional approaches that might
improve the overall consultation process. In particular, the agencies
invite comments on the feasibility and usefulness of developing a
comprehensive, priority-based schedule for completing any necessary
consultations. If such a schedule would be appropriate, how should the
Services and EPA determine which consultations should receive highest
priority? What role, if any, should the public have in forming the
priorities for consultation? How should any priority scheme for
endangered species determinations relate to existing schedules for
reregistration under FIFRA?
IV. Regulatory Assessment Requirements
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), it has been determined that this
ANPR is a ``significant regulatory action'' under section 3(f) of the
Executive Order, because it raises ``novel legal or policy issues
arising out of legal mandates.'' The Agency therefore submitted this
ANPR to OMB for the 10-day review period afforded under this Executive
Order. Any changes made in response to OMB comments during that review
have been documented in the public docket as required by the Executive
Order.
Since this ANPR does not impose any requirements, and instead seeks
comments and suggestions for the Agency to consider in developing a
subsequent notice of proposed rulemaking, the various other review
requirements that apply when an agency imposes requirements do not
apply to this ANPR.
As a part of your comments on this document, you may include any
comments or information that you have regarding these requirements. In
particular, any comments or information that would facilitate the
Agency's assessment of the potential impact of a procedural rule on
small entities pursuant to the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq). The Agency will consider such comments during the
development of the notice of proposed rulemaking as it takes
appropriate steps to address any applicable requirements.
List of Subjects in 50 CFR Part 402
Endangered species, Environmental protection, Pesticides.
Dated: January 9, 2003,
William T. Hogarth.
Assistant Administrator, National Marine Fisheries Service, National
Oceanic and Atmospheric Administration, U.S. Department of Commerce.
Dated: January 8, 2003,
Craig Manson.
Assistant Secretary for Fish and Wildlife and Parks, U.S. Department of
the Interior.
Dated: January 21, 2003,
Christine T. Whitman.
Administrator, U.S. Environmental Protection Agency.
[FR Doc. 03-1661 Filed 1-23-03; 8:45 am]
BILLING CODE 6560-50-S