[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]

[[Page 3785]]


Part IX

Department of Commerce

National Oceanic and Atmospheric Administration


50 CFR Part 402

Department of the Interior

Fish and Wildlife Service


50 CFR Part 402

Environmental Protection Agency

40 CFR Chapter I

Endangered Species and Pesticide Regulation; Proposed Rules

[[Page 3786]]


National Oceanic and Atmospheric Administration

50 CFR Part 402

RIN 0648-AQ69


Fish and Wildlife Service

50 CFR Part 402

RIN 1018-AI95


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.


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.

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: 

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

[[Page 3787]]

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-
    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 
    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 
    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 

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

[[Page 3790]]

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 
    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 

    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. 
    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 

[[Page 3791]]

    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 
    [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 
    [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 
    (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 
    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 
    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 

[[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, 
    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 
    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]