[Federal Register Volume 69, Number 20 (Friday, January 30, 2004)]
[Proposed Rules]
[Pages 4465-4480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1963]


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DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

RIN 1018-AI95

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

[Docket No: 021223326-4022-02]
RIN 0648-AQ69

50 CFR Part 402


Joint Counterpart Endangered Species Act Section 7 Consultation 
Regulations

AGENCIES: Fish and Wildlife Service, Interior; National Marine 
Fisheries Service, National Oceanic and Atmospheric Administration, 
Commerce.

ACTION: Proposed rule.

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SUMMARY: The U.S. Department of the Interior, Fish and Wildlife Service 
(FWS) and the U.S. Department of Commerce, National Oceanic and 
Atmospheric Administration, National Marine Fisheries Service (NOAA 
Fisheries) (referred to jointly as ``Services'' and individually as 
``Service''), after coordination with the Environmental Protection 
Agency (EPA) and the U.S. Department of Agriculture (USDA), are 
proposing joint counterpart regulations for consultation under section 
7 of the Endangered Species Act of 1973, as amended (ESA) for 
regulatory actions under the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA). Counterpart regulations, described in general 
terms in the same part, are intended to provide flexibility in the ways 
that a federal agency may meet its obligations under the ESA by 
creating alternative procedures to the existing section 7 consultation 
process described in the same part. These counterpart regulations would 
complement the existing section 7 consultation process described in the 
same part and enhance the efficiency and effectiveness of the section 7 
consultation process by increasing interagency cooperation and 
providing

[[Page 4466]]

two optional alternatives for completing section 7 consultation for 
FIFRA regulatory actions. One alternative process would eliminate the 
need for EPA to conduct informal consultation and obtain written 
concurrence from the Service for those FIFRA actions that EPA 
determines are ``not likely to adversely affect'' any listed species or 
critical habitat. The other alternative consultation process would 
permit the Service to conduct formal consultation in a manner that more 
effectively takes advantage of EPA's substantial expertise in 
evaluating ecological effects of FIFRA regulatory actions on federally-
protected threatened and endangered species (``listed species'') and 
critical habitats.

DATES: Comments on this proposal must be received by March 30, 2004 to 
be considered in the final decision on this proposal.

ADDRESSES: Comments or materials concerning the proposed rule should be 
sent to the Assistant Director for Endangered Species, U.S. Fish and 
Wildlife Service, 4401 North Fairfax Drive, Room 420, Arlington, 
Virginia 22203. You may also comment via the Internet to 
[email protected]. Please submit Internet comments as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Please also include ``Attn: 1018-AI95'' and your name and 
return address in your Internet message. Comments and materials 
received in conjunction with this rulemaking will be available for 
inspection, by appointment, during normal business hours at the above 
address.
    The FWS has agreed to take responsibility for receipt of public 
comments and will share all comments it receives with NOAA Fisheries, 
EPA and USDA. All the agencies will work together to compile, analyze, 
and respond to public comments.

FOR FURTHER INFORMATION CONTACT: Gary Frazer, Assistant Director for 
Endangered Species, at the above address (Telephone 703/358-2171, 
Facsimile 703/358-1735) or Phil Williams, Chief, Endangered Species 
Division, NOAA Fisheries, 1315 East-West Highway, Silver Spring, MD 
20910 (301/713-1401; facsimile 301/713-0376).

SUPPLEMENTARY INFORMATION: The FWS and NOAA Fisheries are proposing for 
public comment a joint rulemaking to amend existing regulations to 
enhance the efficiency and effectiveness of the consultation process 
under section 7 of the ESA and to provide alternatives to the way EPA 
now consults with the Services under the ESA on regulatory actions 
under FIFRA involving pesticides. This Notice of Proposed Rulemaking 
(NPR), developed with assistance from EPA and the USDA, would 
complement the Services' existing consultation regulations in 50 CFR 
part 402. A rule providing an alternative consultation process for a 
specific Federal agency is called a ``counterpart regulation.'' See 50 
CFR 402.04. The purpose of this proposed rule is to improve interagency 
cooperation for regulatory actions under FIFRA involving pesticides, 
and provide optional, alternative approaches to consultation on 
pesticide actions that better integrate the consultation process under 
section 7 of the ESA with the processes for pesticide regulatory 
actions taken by EPA under FIFRA. By doing so, the Services expect the 
administration of the ESA and FIFRA will better protect threatened and 
endangered species and critical habitat with minimal disruption of the 
nation's access to products licensed under FIFRA that are necessary for 
the production of food and fiber and for health and disease protection. 
Additional supplementary information concerning this proposed rule is 
available on the Internet at http://endangered.fws.gov/consultations/pesticides.

1. The Endangered Species Act and Federal Agency Consultations With the 
Services

    Congress enacted the ESA to establish a program for conservation of 
endangered and threatened species and the ecosystems on which they 
depend. 16 U.S.C. 1531(b). Section 7 of the ESA, 16 U.S.C. 1536, 
imposes obligations upon all Federal agencies whose actions may affect 
listed species or designated critical habitat. Section 7(a)(2) of the 
ESA, 16 U.S.C. 1536(a)(2) directs all Federal agencies, in consultation 
with and with the assistance of the Secretaries of the Interior and 
Commerce (delegated to the respective Services), to insure 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 FWS and NOAA Fisheries are jointly responsible for 
administering the ESA.
    The Services adopted joint consultation regulations set forth at 50 
CFR part 402. These regulatory provisions require action agencies to 
consult with the Services on any Federal action that ``may affect'' a 
listed species or critical habitat. Consultation may be concluded 
``informally'' if the action agency determines that the Federal action 
under consideration is ``not likely to adversely affect'' (NLAA) a 
listed species or critical habitat and the Service gives written 
concurrence. 50 CFR 402.13(a)(1). Such informal consultation fulfills 
the action agency's section 7 consultation obligation. 50 CFR 
402.14(b)(1). Formal consultation, however, may always be pursued and 
is required if the action is likely to adversely affect a listed 
species or critical habitat or if the Service does not concur with an 
action agency's NLAA determination. During formal consultation, the 
action agency and Service examine the effects of the proposed action 
and the Service determines 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 
and whether incidental take of listed species is anticipated. 50 CFR 
402.14(h), 402.14(i).
    Under the current consultation regulations, 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. Additionally, examination of potential 
effects must also address ``interrelated'' and ``interdependent'' 
actions. 50 CFR 402.02. ``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. For a detailed explanation of these 
terms, refer to the Consultation Handbook jointly published by FWS and 
NOAA Fisheries, which further elaborates on the procedures followed by 
the Services when conducting section 7 consultations. http://endangered.fws.gov/consultations/s7hndbk/s7hndbk.htm.
    At the conclusion of formal consultation, the Service will issue a 
biological opinion that details the effects of the action on the listed 
species or critical habitat, and states 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

[[Page 4467]]

U.S.C. 1536(b)(3)(A). If the Service finds an agency action is likely 
to cause any such effect, the biological opinion must also include 
reasonable and prudent alternatives, if any are available, that would 
avoid the effect. Where jeopardy or adverse modification of critical 
habitat is not likely to occur, but take of listed species is expected, 
the Service issues an incidental take statement that specifies 
reasonable and prudent measures and terms and conditions necessary to 
minimize incidental take. 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 any prohibition 
against take that may otherwise apply. 16 U.S.C. 1538(a)(1); 1533(d). 
Following consultation, the action agency is responsible for 
implementing protections, if necessary, through its available 
authority.
    Regulations at 50 CFR 402.04 provide that ``the consultation 
procedures may be superseded for a particular Federal agency by joint 
counterpart regulations among that agency, the Fish and Wildlife 
Service, and the National Marine Fisheries Service.'' The Services 
recognized that in certain instances, the section 7 consultation 
process can be improved by procedures that differ from the standard 
consultation process. The purpose of counterpart regulations therefore 
is to provide an approach that ``allow[s] individual Federal agencies 
to ``fine tune'' the general consultation framework to reflect their 
particular program responsibilities and obligations.'' 51 FR 19937 
(June 3, 1986). At the same time, the preamble to the 1986 regulations 
for implementing section 7 of the ESA states that ``such counterpart 
regulations must retain the overall degree of protection afforded 
listed species required by the [ESA] and these regulations. Changes in 
the general consultation process must be designed to enhance its 
efficiency without elimination of ultimate Federal agency 
responsibility for compliance with section 7.'' Id. (quoting the 
preamble justification for the predecessor regulation).

2. 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 section 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 section 2(a). Ingredients 
which are not active are referred to as ``inert ingredients'' or 
``other ingredients.'' Under FIFRA, an ``inert ingredient'' is defined 
as ``an ingredient which is not active.'' FIFRA section 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.
    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 section 
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 labeling limiting 
application to specific uses. 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. The 
proponent of use bears the burden of demonstrating that a pesticide 
meets this 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 section 
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 section 2(bb). EPA has a broad duty under FIFRA to avoid 
unreasonable adverse effects on the environment generally, which 
includes consideration of effects to all species, whether or not 
federally protected.
    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 section 2(p). FIFRA makes it unlawful for any person ``to 
use any registered pesticide in a manner inconsistent with its 
labeling.'' FIFRA section 12(a)(2)(G). Thus, directions and 
restrictions appearing on, or referenced in, a pesticide product label 
become enforceable Federal requirements subject to penalties for 
misuse. Under FIFRA, most States have primary responsibility for 
enforcement against pesticide misuse. See FIFRA section 26.
    While most regulatory decisions allowing entry of new pesticide 
products into the marketplace are made by EPA in its FIFRA Sec. 3 
registration program, there are three other programs that can authorize 
the limited 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 section 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 
section 24(c)(2). Finally, EPA may issue an experimental use permit 
under FIFRA section 5 authorizing the limited use of an unregistered 
pesticide in field experiments to obtain data necessary to support an 
application for registration. See 40 CFR part 172.
    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

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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 
section 4. As part of the reregistration process, 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 section 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 section 6 and 40 
CFR part 164.
    EPA may issue a Notice of Intent to Cancel the registration of a 
pesticide if it appears at any time that the continued use of the 
pesticide ``generally causes unreasonable adverse effects on the 
environment.'' FIFRA section 6(b). The registrant of a pesticide is 
required to submit to EPA additional factual information regarding 
unreasonable adverse effects. FIFRA section 6(a)(2); 40 CFR part 159. 
The decisions whether to approve a pesticide's entry into the 
marketplace and whether to retain a pesticide on the market are based 
on the most recent scientific information and the same standard: 
whether use of pesticide does not cause ``unreasonable adverse effects 
on the environment.'' 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 section 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 section 2(l).
    EPA's approach to 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. A more detailed description of EPA's approach appears in a 
paper titled: ``Overview of the Ecological Risk Assessment Process in 
the Office of Pesticide Programs, U.S. Environmental Protection 
Agency'' (``Overview Paper'') (January 2004), and in documents 
referenced in that paper, all of which are part of the administrative 
record of this NPR. This document describes EPA's risk evaluation 
process which is based on the current science policy views of EPA's 
pesticide program, but it is not intended to be legally binding. In any 
decision under FIFRA, EPA may: (1) conclude that the general approach 
to assessing ecological risks of a particular pesticide is 
inapplicable; or (2) consider factors or types of information other 
than those described in the Overview Paper. If EPA uses a different 
approach to make an effects determination for a FIFRA action, EPA would 
provide a detailed explanation of its approach in the record for the 
action.
    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 EPA's risk assessment 
methods have included methodology for an assessment of potential risks 
to listed species.
    EPA's approach to assessing risks of pesticides and framework for 
making regulatory decisions benefits from the advice of several 
advisory committees chartered under the Federal Advisory Committee Act 
(FACA). EPA routinely obtains independent, external, expert scientific 
peer review of its risk assessment methodologies from the FIFRA 
Scientific Advisory Panel (SAP). Authorized under FIFRA section 25(d), 
the SAP is chartered under FACA and consists of seven permanent members 
appointed by the EPA Administrator and additional ad hoc members who 
are selected to serve on panels addressing specific scientific issues 
to which they can contribute their expertise. The SAP provides EPA with 
recommendations and evaluations of data, models, and methodologies used 
in EPA's overall risk assessment processes that occur during 
registration and reregistration. Further information is available at: 
http://www.epa.gov/scipoly/sap/.
    EPA also works with stakeholders in the regulated community and 
environmental and public health advocacy groups through two other FACA-
chartered groups: the Pesticide Program Dialogue Committee (PPDC) and 
the Committee to Advise on Reassessment and Transition (CARAT). For 
further information see: http://www.epa.gov/pesticides/ppdc/ and http://www.epa.gov/pesticides/carat/. These latter two advisory groups often 
address ways in which to make regulatory processes more reliable and 
efficient. All three advisory groups comply with the FACA requirements 
for transparency and balanced participation.
    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. Laboratory 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.
    EPA 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 listed 
species, of 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

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aquatic organisms are available, EPA will consider them in establishing 
the toxicity endpoint for risk assessment. EPA conducts 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.
    EPA 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). When estimating EEC, EPA makes 
conservative assumptions designed not to understate potential exposure 
in order to avoid the potential for underestimating risk.
    When assessing risks to listed species and critical habitat, EPA 
evaluates data and risks in a tiered fashion. EPA compares its toxicity 
assessment of an active ingredient with the EEC. As part of a 
conservative initial risk screening, if this comparison demonstrates 
that the EEC is well below the amount of active ingredient that would 
be expected to cause harm to particular species or critical habitats, 
EPA concludes that the use of pesticide products containing that active 
ingredient would have ``no effect'' on those listed species or critical 
habitats. Most of EPA's focus is on the potential risks from exposure 
to the active ingredient and its significant environmental degradates. 
EPA also reviews the available information on the other ingredients in 
pesticide products and on the formulations themselves, to assess the 
potential for increased risk. If the conservative initial screening 
assessment indicates that a use of a pesticide may potentially affect a 
listed species or critical habitat, EPA conducts a more refined 
assessment looking at species-specific information and information 
about pesticide use in the area to determine whether, for example, 
there is spatial and temporal overlap of the pesticide use and species' 
habitat, such that adverse effects would appear likely.
    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 or critical habitat, then EPA may require the 
pesticide applicant or registrant to supply additional laboratory and/
or field data in order to refine the risk assessment, seek changes in 
the allowable use of the pesticide product that are sufficient to 
mitigate any potential risk, or request initiation of consultation with 
the Services. 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.
    Between May and December 2003 inter-agency scientific teams from 
both Services and EPA carefully reviewed EPA's ecological risk 
assessment methodology, including earlier drafts of the Overview Paper 
and the materials referenced therein. Based on this review, the 
Services have determined that the approach used by EPA designated will 
produce effects determinations that reliably assess the effects of 
pesticides on listed species and critical habitat pursuant to section 7 
of the ESA and implementing regulations. The approach used by EPA 
addresses, where applicable, the informational and analytical 
requirements set forth at 50 CFR 402.14(c), relies upon the best 
scientific and commercial data available; and analyzes the best 
scientific and commercial data available by using sound, scientifically 
accepted practices for evaluating ecological effects. Additionally, the 
Services have concluded that the approach used by EPA should produce 
effects determinations that appropriately identify actions that are not 
likely to adversely effect listed species, and that are consistent with 
those that otherwise would be made by the Services. This approach also 
will produce all information necessary to initiate formal consultation 
where appropriate. Letter from S. Williams and W. Hogarth to Susan 
Hazen (January 2004).

3. Public Law 100-478

    In 1988, Congress addressed the relationship between ESA and EPA's 
pesticide labeling program in section 1010 of Public Law 100-478 
(October 7, 1988), which 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. This law provided a clear 
sense that Congress desires 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 have coordinated with USDA in developing these counterpart 
regulations to ensure that the consultation process is efficient and 
timely while remaining as protective as the existing regulations.

4. The Joint Advance Notice of Proposed Rulemaking on Pesticides and 
Endangered Species

    On January 24, 2003 the Services and EPA published an Advance 
Notice of Proposed Rulemaking (ANPR) inviting public comment on a 
variety of ideas for improving the process by which EPA and the Service 
work together to protect listed species and critical habitat. 68 FR 
3785. The ANPR sought public comment on possible approaches to changing 
the current regulations, policies, and practices of the EPA and Service 
to better integrate the FIFRA and ESA processes and to improve the 
efficiency and effectiveness of consultations on pesticide actions. The 
agencies specifically identified several broad approaches to changing 
the current process. For example, the ANPR asked for comment on whether 
it would 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 that share 
key common characteristics. Under existing Service regulations at 50 
CFR part 402, the Service 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 addition, even 
where such programmatic consultations would not be sufficient to 
complete the consultation process for certain individual actions, the 
Notice asked for comment on whether they could serve to improve the 
consultation process on such actions through the standardization of 
risk assessment methodologies and alternatives for species protections.
    The ANPR also requested comment on an approach that would 
streamline the informal consultation process. For

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this approach, which is reflected in the counterpart regulation being 
proposed today, the ANPR asked for comment on 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.
    The agencies also sought comment on an approach that would focus 
the review by the Service during consultation. This approach was 
predicated on the assumption that 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 listed 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. In view of this expertise, the 
ANPR therefore asked for comment on whether the Service should rely on 
EPA's assessment of effects once formal or informal consultation had 
been initiated on a pesticide regulatory action.
    The ANPR also asked 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. The ANPR covered the following topics:
     Modifying EPA's approach to assessing potential 
risk to listed species
     Introducing flexibility in the scope of 
consultations
     The content of consultation packages and 
definition of the term ``best scientific and commercial data 
available''
     Establishing timelines for conducting informal 
and formal consultations on pesticide regulatory actions
     Establishing procedures for consultations on 
emergency actions under FIFRA
     Clarifying the role of the Service
     Establishing procedures for public participation 
and clarifying the meaning of the term, ``applicant,'' in the context 
of consultations between EPA and the Services on pesticide regulatory 
actions
     Clarifying and improving the roles of States, 
Tribes, and other entities that might potentially act as non-Federal 
representatives in consultations between EPA and the Services on 
pesticide regulatory actions
     Fees
     Process for elevating and resolving 
disagreements between EPA and the Service
    In response to the ANPR, the Services received comments from over 
300 groups, organizations, and individuals, about half of which were 
letters and post cards from different individuals making the same 
comment. Comments came from a wide range of stakeholder organizations 
and individuals and presented a diverse array of opinions about what 
actions the government should take to promote and ensure EPA compliance 
with the ESA for actions under FIFRA. While most commenters expressed 
support for the goals of the ESA and many recognized the need to 
implement the ESA in a manner that was efficient and compatible with 
FIFRA, there were strongly differing perspectives about what course 
would best achieve those goals.
    In general, environmental advocacy groups raised a number of 
criticisms about EPA's approach to assessing the risks of pesticides 
and regulating their use, and argued that historically EPA has had a 
poor record of compliance with the consultation obligations of the ESA 
with regard to pesticides. These commenters therefore favored a strong 
role for the Services and opposed any changes to the existing 
consultation regulations. In particular, they argued that a rule which 
either allowed EPA to make NLAA determinations, without consulting with 
and obtaining the concurrence of the Service, or afforded deference to 
EPA's assessments, would be contrary to the ESA. Moreover, such a rule 
would contain insufficient safeguards to assure proper application of 
the ESA and could be subject to abuse by EPA.
    Agricultural pesticide user groups and pesticide manufacturers and 
trade associations generally stressed the extensive expertise EPA 
possesses in the assessment of pesticides' ecological risks and the 
benefits of a more efficient and consistent process. They also argued 
that the existing consultation regulations were designed primarily for 
agency actions that involved construction projects or other actions 
with a relatively limited geographic scope and therefore were 
inappropriate for the types of regulatory actions taken by EPA under 
FIFRA. They also questioned whether the Services had the resources and 
expertise to review FIFRA actions and pointed out that the time 
required to conduct consultations would delay decisions about the use 
of socially beneficial pesticides. These commenters therefore expressed 
support for new consultation procedures that would give EPA greater 
flexibility to reach conclusions under the ESA about the impact of 
FIFRA actions on listed species and critical habitat, with reduced or 
no involvement by the Services.
    The Services and EPA have considered all of the comments, and the 
Services conclude that the goals of the ESA can be fully met using new, 
more efficient administrative processes that take advantage of EPA's 
expertise while retaining a strong role for the Services throughout the 
consultation process to assure that the requirements of the ESA are 
met. Accordingly, the Services are now proposing a counterpart 
regulation for consultation on FIFRA actions.

5. Reasons for a Counterpart Regulation for EPA Pesticide Actions

    Rationale for the rule as proposed. In developing a process for 
conducting future ESA consultations on FIFRA pesticide regulatory 
actions, the Services and EPA recognized that EPA possesses significant 
resources, expertise and authority in the field of ecological risk 
assessment relative to pesticides. 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 a significant body of 
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 maintains a 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 EPA's strong scientific data bases and its expertise 
in the field of ecological risk assessment, EPA's decisions have 
characteristics that are rarely found in other section 7 consultations. 
Pesticide products typically are employed for multiple uses, and can 
potentially be used in many different parts of the country in different 
times of year. Thus, an ESA consultation on a pesticide registration 
must consider many different pesticide use patterns and determine 
whether wildlife or plant species in many different locations 
throughout the country may be affected by such use. This broad scope of 
intended use of the

[[Page 4471]]

product under review contrasts with the narrower geographical scope of 
most actions by Federal agencies that undergo section 7 consultation.
    In addition, the number of annual pesticide decisions made by EPA 
is also a factor potentially affecting how best to improve the section 
7 consultation process. In a typical year, EPA will make hundreds of 
significant decisions regarding pesticide registration. For example, in 
fiscal year (FY) 2003, EPA registered 31 new pesticide active 
ingredients; approved the addition of 334 new uses of previously 
registered active ingredients on over 1,500 different crops; and 
completed more than 6,500 more minor registration actions. EPA also 
completed re-registration assessments on 28 previously registered 
active ingredients, and processed nearly 500 emergency exemption 
requests in FY 2003. Numbers of actions in most of these categories 
have risen each year since FY 2000. The number of requests by EPA to 
initiate consultation on pesticide actions is expected to increase 
substantially in future years. The large number of consultations and 
their complexity is expected to require a significant level of 
resources, requiring careful use of resources by both EPA and the 
Services to effectively address issues of high biological priority and 
high priority to users in the most efficient manner possible. This 
rule, if finalized, may make the consultation process more efficient 
because some FIFRA actions could be conducted pursuant to the 
alternative consultation procedures outlined in this rule.
    These factors provide strong reasons for the Services to propose 
establishing a counterpart rule for EPA FIFRA actions. New, streamlined 
procedures promise to be more efficient for both EPA and the Services, 
and potentially more protective of listed species, because they would 
allow EPA and the Services to focus more resources on those actions 
most likely to pose risk to listed species. The single greatest 
opportunity for efficiency in the consultation process is for the 
Services to take greater advantage of the extensive analysis produced 
by EPA in its ecological risk assessments of pesticides. Relying more 
heavily on the EPA's scientific work product, while at the same time 
assuring EPA's analysis meets the high scientific standards required by 
the ESA, will reduce the amount of work required from the Services in 
each consultation and therefore accelerate completion of consultations.
    Further, those streamlined procedures are expected to enable EPA to 
more quickly implement any risk mitigation measures identified as 
necessary to protect species and critical habitat. Moreover, many of 
the applications submitted for registration of pesticide products 
containing new active ingredients involve pesticide formulations that 
have been developed to have less impact than the currently registered 
products with which they would compete. Thus, any improvements in the 
efficiency and effectiveness of the ESA review process to put these new 
products in the market sooner could benefit listed species, as well as 
more broadly provide benefits for human health and the environment. 
Finally, given the importance of maintaining the availability of 
pesticides for production of food and fiber, disease prevention and 
other purposes that are essential to the health and well-being of the 
American people, EPA and the Services believe that improved integration 
of the FIFRA registration/reregistration and section 7(a)(2) 
consultation processes under new counterpart regulations can be 
achieved in a way that avoids unnecessary burdens on pesticide users 
with no sacrifice to the protection of listed species.

6. The Proposed Counterpart Rule

    The proposed counterpart regulations would establish new methods of 
interagency coordination between EPA and the Services and create two 
new, optional, alternative approaches for EPA to fulfill its 
obligations to ensure that its actions under FIFRA are not likely to 
jeopardize the continued existence of listed species or destroy or 
adversely modify critical habitat. The proposed rule offers a new 
alternative approach when EPA determines that a FIFRA action is not 
likely to cause adverse effects on listed species or critical habitat, 
and a new alternative approach to formal consultations. EPA could also 
elect to follow any of the existing procedures for early (Sec. 402.11), 
informal (Sec. 402.13), or formal consultation (Sec. 402.14) described 
in subpart B of part 402 for these actions.

A. New Methods of Interagency Cooperation

    The proposed counterpart rule would establish three additional 
methods (Sec.Sec. 402.42(b), 402.43 and 402.44) of achieving the 
interagency cooperation that is the fundamental tenet of the section 7 
consultation process. First, under Sec. 402.43 EPA could request the 
Service to provide available information (or references thereto) 
describing the applicable environmental baseline for each species or 
habitat that EPA determines may be affected by a FIFRA action, and the 
Service would provide such information within 30 days of the request. 
This informational exchange would give EPA early and effective access 
to the Service's extensive biological database.
    Second, under Sec. 402.44 EPA may request the Service to designate 
a suitably-trained Service Representative (more than one Service 
employee may jointly serve in this capacity) to participate with EPA in 
the development of an ``effects determination'' for one or more of 
those species or habitats. The Service Representative will participate 
in all relevant discussions with the EPA team (in most cases in 
person), have access to all documentation and information used to 
prepare the effects determination (upon acceptance of the same 
confidentiality limitations applicable to EPA personnel), and have 
appropriate office and staff support to work effectively as part of the 
EPA team. The Service Representative will be expected to keep the 
Service informed at all times as to the progress and scope of the 
effects determination, and the Service may engage in additional 
coordination with EPA as appropriate. In some cases, EPA may decide 
that it does not require the aid of a designated Service 
Representative, and may make an effects determination without that form 
of coordination.
    Third, under Sec. 402.42(b), EPA and the Services would establish 
new procedures for regular and timely exchanges of scientific 
information to achieve accurate and informed decision-making.

B. Consultation on Actions That Are Not Likely To Adversely Affect 
Species or Habitats

    The existing section 7 regulations require an action agency to 
complete formal consultation with the Service on any proposed action 
that may affect a listed species or critical habitat, unless following 
either a biological assessment or informal consultation with the 
Service, the action agency makes a determination that the proposed 
action is not likely to adversely affect any listed species or critical 
habitat and obtains written concurrence from the Service for the NLAA 
determination. The alternative consultation process contained in 
section 402.45 of the proposed counterpart regulation will allow the 
Service to provide training, oversight, and monitoring to EPA through 
an alternative consultation agreement that enables EPA to make an NLAA 
determination for a FIFRA action without formal or informal 
consultation

[[Page 4472]]

or written concurrence from the Service. The Services recently adopted 
a similar approach for certain Federal actions implementing the 
National Fire Plan. 68 FR 68254 (December 8, 2003).
    The new approach to interagency coordination between EPA and the 
Services is intended to be a flexible, adaptable scheme that will 
continually evolve and improve over time as scientific knowledge 
expands. For this reason, although the proposed regulation would 
require the Service and EPA to have in effect an alternative 
consultation agreement before EPA can utilize the procedures of section 
402.45, the alternative consultation agreement itself is not part of 
this rule, and the Services have concluded that the alternative 
consultation agreement would not constitute a rule subject to the 
notice and comment provisions of the Administrative Procedure Act, 5 
U.S.C. 553. As articulated in proposed section 402.45(b), the required 
content of the alternative consultation agreement include provisions 
and procedures to guide the Services and EPA in implementing this 
subsection. The alternative consultation agreement does not create or 
mandate standards for effects determinations; nor does it limit EPA's 
or the Service's discretion in developing and applying scientific 
methodologies. The alternative consultation agreement would be expected 
to undergo continuous modification and improvement. EPA and the Service 
would also be able to mutually agree to depart from the terms of the 
alternative consultation agreement in a particular case. Further, the 
alternative consultation agreement would not create any substantive or 
procedural rights or benefits that could be enforced by third parties 
against either the Services or EPA.
    The Services believe that EPA's expertise in ecological risk 
assessments of pesticides, together with the safeguards built into the 
alternative consultation agreement, make case-by-case discussions and 
written concurrences in EPA's NLAA determinations unnecessary for FIFRA 
actions. The Services have carefully reviewed EPA's assessment 
methodologies and believe that when EPA follows its established 
approach to ecological risk assessment for pesticides EPA will 
correctly make determinations as to when a pesticide is or is not 
likely to adversely affect listed species or critical habitat. 
Requiring the Services to concur on a case by case basis on every NLAA 
determination made by EPA would unjustifiably divert much of the 
Services' consultation resources away from projects in greater need of 
consultation. The proposed counterpart regulations will increase the 
Services' capability to focus on Federal actions requiring formal 
consultation by eliminating the requirement to provide written 
concurrence for actions within the scope of the proposed counterpart 
regulations. EPA and the Services are committed to implementing this 
authority in a manner that will be equally as protective of listed 
species and critical habitat as the current procedures that require 
written concurrence from the Service.
    These proposed counterpart regulations provide an additional tool 
for accelerating EPA's ESA compliance activities, while providing equal 
or greater protection of listed species and critical habitat. Under 
current procedures, EPA already must complete and document a full ESA 
analysis to reach an NLAA determination. The proposed counterpart 
regulations permit a FIFRA action to proceed following EPA's NLAA 
determination without an overlapping review by the Service, where the 
Service has provided specific training and oversight to achieve 
comparability between EPA's determination and the outcome of an 
overlapping review by the Service.
    The approach proposed in these counterpart regulations is 
consistent with Subpart B because it leaves the standards for making 
jeopardy and NLAA determinations unchanged. Further, when EPA operates 
under these proposed counterpart regulations it will retain full 
responsibility for compliance with section 7 of the ESA.
    Under the proposed rule, EPA would enter into an alternative 
consultation agreement with either FWS, NOAA Fisheries or both. The 
alternative consultation agreement will include: (1) A description of 
the actions that EPA and the Service have taken to document the 
approach EPA uses to make determinations regarding the effects of its 
actions on listed species or critical habitat and to evaluate that 
approach for consistency with the ESA and applicable implementing 
regulations; (2) a description of the program for developing and 
maintaining the skills necessary within EPA to make NLAA 
determinations, including a jointly developed training program based on 
the needs of EPA; (3) provisions for incorporating new information and 
newly listed species or critical habitat into EPA's effects analysis on 
FIFRA actions; (4) processes that EPA and the Service will use to 
incorporate scientific advances into EPA's effects determinations; (5) 
a description of a mutually agreed upon program for periodic program 
evaluations; and (6) provisions for EPA to maintain a list of FIFRA 
actions for which EPA has made NLAA determinations. By following the 
procedures in these counterpart regulations, including the 
establishment of the alternative consultation agreement, EPA would 
fulfill its ESA section 7 consultation responsibility for actions 
covered under these proposed regulations.
    The purpose of the jointly developed training program between EPA 
and the Service is to ensure that EPA consistently interprets and 
applies the provisions of the ESA and the regulations (50 CFR part 402) 
relevant to these counterpart regulations with the expectation that EPA 
will reach the same conclusions as the Service. It is expected that the 
training program will rely upon the ESA Consultation Handbook as much 
as possible.
    The Service will use monitoring and periodic program reviews to 
evaluate EPA's performance under the alternative consultation agreement 
at the end of the first year of implementation and then at intervals 
specified in the alternative consultation agreement. The Service will 
evaluate whether the implementation of this regulation by EPA continues 
to be consistent with the best scientific and commercial data available 
and the ESA. The result of the periodic program review may be to 
recommend changes to EPA's implementation of the alternative 
consultation agreement. The Service will retain discretion for 
terminating the alternative consultation agreement if the requirements 
under the counterpart regulations are not met. However, any such 
suspension, exclusion, or termination will not affect the legal 
validity of determinations made prior to the suspension, exclusion, or 
termination.
    Upon completion of an alternative consultation agreement, EPA and 
the Service will implement the training program outlined in the 
alternative consultation agreement. EPA will have full responsibility 
for the adequacy of its NLAA determinations since there would be no 
reviewable final agency action by the Service when EPA makes a NLAA 
determination for a FIFRA action.
    The Services and EPA have developed a draft of an alternative 
consultation agreement that addresses the topics identified in proposed 
Sec. 402.45. This draft alternative consultation agreement is part of 
the administrative record of this proposed rule. The public is 
encouraged to read the draft alternative consultation agreement to 
obtain a better understanding of how the Services anticipate the 
requirements of Sec. 402.45 would be satisfied. Such an

[[Page 4473]]

understanding may be useful in preparing comments on the proposed rule.

C. New Optional Formal Consultation Process

    The proposed counterpart regulation establishes a new formal 
consultation process (Sec. 402.46) that would meet all statutory 
requirements and closely follows the procedural steps specified in the 
current subpart B process. The new process would combine the central 
concepts and procedures of the subpart B consultation process with 
innovations stemming from EPA's expertise in assessing the ecological 
effects of pesticide products.
    The process relies on an effects determination that would be 
prepared by EPA according to analytical methodologies that the Services 
have reviewed and endorsed. The effects determination may be prepared, 
upon EPA's request, with the assistance of a Service Representative. 
While the contents of an effects determination would depend on the 
nature of the action, an effects determination submitted under Sec. 
402.46 or Sec. 402.47 would contain the information described in Sec. 
402.14(c)(1)-(6) and a summary of the information on which the 
determination is based, detailing how the FIFRA action affects the 
listed species or critical habitat. EPA could also include three 
additional sections in an effects determination: (1) A conclusion 
whether or not the FIFRA action is likely to jeopardize the continued 
existence of any listed species or result in the destruction or adverse 
modification of critical habitat and a description of any reasonable 
and prudent alternatives that may be available; (2) a description of 
the impact of any anticipated incidental taking of such listed species 
resulting from the FIFRA action, reasonable and prudent measures 
considered necessary or appropriate to minimize such impact, and terms 
and conditions necessary to implement such measures; and (3) a summary 
of any information or recommendations from an applicant. An effects 
determination with the required information and the additional 
discretionary sections would contain the information currently provided 
by the Service in a biological opinion. All effects determinations 
would be based on the best scientific and commercial data available.
    Once EPA has prepared an effects determination for the species and 
habitats that may be affected, it may initiate formal consultation on a 
FIFRA action under this section by delivering to the Service a written 
request for consultation. The written request would be accompanied by 
an effects determination prepared under Sec. 402.40(b) and a list or 
summary of all references and data relied upon in the determination. 
The Service will be able on request to review any or all of the 
references and data relied upon in the determination as if it was in 
the Service's files. The time for conclusion of the consultation under 
section 7(b)(1) of the Act would run from the date the Service receives 
the written request from EPA. Any subsequent interchanges between the 
Service and EPA regarding the information submitted by EPA, including 
interchanges about the completeness of EPA's effects determination, 
would occur during consultation, and would not delay the initiation of 
consultation or extend the time for conclusion of the consultation 
unless EPA withdraws the request for consultation.
    If EPA has prepared the effects determination without a designated 
Service Representative, the Service retains the discretion to determine 
within 45 days that additional available information would provide a 
better information base for the effects determination and may so notify 
EPA. After such a notification, EPA may revise the effects 
determination and resubmit it to the Service. The timing and form of 
EPA's resubmission are within its discretion, but the time limitations 
in section 7(b)(1) continue to apply. A request for additional 
information does not represent a finding by the Service that the 
effects determination was not based on the best scientific and 
commercial data available. Further, any requested additional 
information must actually be available to EPA during the specified 
consultation period. Where a designated Service Representative has 
participated in the development of the effects determination, the 
Service will rely upon its representative to identify all desired 
available information during the preparation of the determination, and 
this intermediate Service review during consultation is not needed. 
However, EPA at all times retains its duty to use the best scientific 
and commercial data available for its effects determinations, and the 
Services retain their duty to use the best scientific and commercial 
data available during consultation. Once an effects determination has 
been resubmitted following an additional information determination, the 
Service will proceed to conclude the consultation without further 
requests to EPA for additional information, although the Service may 
consider additional information at any time during the consultation 
process. If EPA advises the Service it will not resubmit a revised 
effects determination to the Service after the Service requests 
additional information, its initiation of consultation on the effects 
determination would be deemed withdrawn.
    Within the later of 90 days after the Service receives EPA's 
written request for consultation or 45 days after the Service receives 
an effects determination resubmitted following an additional 
information determination by the Service, the Service will take one of 
three actions: (1) If the Service finds that the effects determination 
contains all required information and satisfies the requirements of 
section 7(b)(4) of the Act, and the Service concludes that the FIFRA 
action that is the subject of the consultation complies with section 
7(a)(2) of the Act, the Service would issue a written statement 
adopting the effects determination; or (2) it may provide EPA a draft 
written statement modifying the effects determination and as modified 
adopting the effects determination; or (3) it may provide EPA a draft 
jeopardy biological opinion along with any reasonable and prudent 
alternatives if available. Providing these draft documents to EPA is 
consistent with current agency practice under existing consultation 
procedures. The deadlines for Service action are subject to section 
7(b)(1) of the Act.
    If the Service provides either the draft statement modifying the 
effects determination or draft jeopardy opinion, EPA would be required 
to make it available to any applicant upon request. The proposed rule 
would also accommodate EPA's existing discretion to make these draft 
documents available to the general public for comment within the time 
periods provided in the draft rule. The Service would on request meet 
with EPA and any applicant, each of which may submit written comments 
to the Service on the draft document within 30 days or a longer period 
if extended under section 7(b)(1) of the Act. The Service will issue a 
final biological opinion or final written statement within 45 days 
after EPA receives the draft opinion or statement from the Service 
unless the deadline is extended under section 7(b)(1) of the Act. Any 
such final opinion or statement will be signed by the Service Director, 
who may not delegate this authority beyond certain designated 
headquarters officials, and would constitute the opinion of the 
Secretary and the incidental take statement, reasonable and prudent 
measures, and

[[Page 4474]]

terms and conditions under section 7(b) of the Act.
    Where consultation on a FIFRA action will be unusually complex due 
to factors such as the geographic area or number of species that may be 
affected by the action, a special provision (Sec. 402.47) allows EPA, 
after conferring with the Service, to address the effects of the action 
through successive effects determinations addressing groupings or 
categories of species or habitats as established by EPA. This provision 
is needed because for some widely-used pesticides, delaying the 
initiation of consultation until adequate information is available for 
every species or habitat that may be affected by the pesticide may 
result in denying some of the most vulnerable species the benefits of 
the section 7 consultation process for as much as several years. 
Further, allowing geographic or other functional groupings of species 
lets EPA and the Service conduct related biological inquiries together 
in an efficient, coordinated manner. EPA would use this provision after 
conferring with the Services, and EPA and the Services intend to 
collaboratively identify priorities where use of this provision would 
most effectively address these biological goals. When successive 
effects determinations are prepared, EPA may initiate consultation 
based upon each such effects determination using the procedures in Sec. 
402.46(a). The procedure in Sec. 402.46(b) and (c) would apply to the 
consultation. The written statement or opinion provided by the Service 
under Sec. 402.46(c) would constitute a partial biological opinion as 
to the species or habitats that are the subject of the consultation. 
The partial biological opinion would describe the provisions relating 
to incidental take of such species for inclusion in an incidental take 
statement at the conclusion of consultation, giving users of pesticide 
products such as farmers and forest managers, nursery operators, and 
other pesticide users prompt and reliable guidance for minimizing 
incidental take of the species. EPA would also retain authority to use 
such a partial biological opinion, along with other available 
information, in making a finding under section 7(d) of the Act as to 
whether the FIFRA action constitutes an irreversible and irretrievable 
commitment of resources which has the effect of foreclosing the 
formulation or implementation of any reasonable and prudent alternative 
as to those species and habitats. After conclusion of all consultation 
on the FIFRA action, the previously-issued partial biological opinions 
would then collectively constitute the opinion of the Secretary and the 
incidental take statement, reasonable and prudent measures, and terms 
and conditions under section 7(b) of the Act unless a partial 
biological opinion were to be modified by the Service using the 
procedures in Sec. 402.46(c). For pesticide products currently in use, 
this process would provide prompt guidance for substantial protection 
for vulnerable species without unduly disrupting longstanding patterns 
of pesticide use in agriculture, public health vector control or other 
important pesticide use patterns throughout the country that are vital 
to the health and welfare of the American people.
    The Services emphasize that Sec. 402.47 is not intended as an 
authorization for EPA to take actions, such as registration of 
pesticides containing new active ingredients or registration of new 
uses, without complying with the requirements of section 7(a)(2) of the 
Act. The provision would not reduce EPA's consultation duties compared 
to Subpart B. Rather, for certain complex FIFRA actions the provision 
would strengthen EPA's and the Services' ability to establish the most 
effective sequence for completing EPA's consultation obligations 
through a series of focused consultations on specific species or 
habitats. EPA would not satisfy its procedural obligations under 
section 7(a)(2) of the ESA until all necessary consultations are 
completed. Likewise, the Services' issuance of a partial biological 
opinion following each such focused consultation would not represent 
the opinion of the Secretary or an incidental take statement under 
section 7(b) of the ESA until consultation is concluded on all listed 
species and habitats that may be affected by the action.
    The Services expect this provision may be used for FIFRA actions in 
a variety of circumstances. For example, after reviewing an action, EPA 
might identify differing levels of risk for different species, and 
might conclude that it would be prudent to seek Service advice on the 
impacts of concern through formal consultation while EPA continued to 
analyze the lesser risk concerns. In addition, if EPA needs to update 
completed consultations on pesticides by addressing impacts on more 
than one newly listed species, EPA might find it more efficient and 
effective to consider each species separately, even though a particular 
pesticide might impact more than one of the newly listed species. 
Nonetheless, EPA has advised the Services that EPA does not intend to 
register any new use or active ingredient until completion of 
consultation under section 7(a)(2) for all species affected by that 
action. However, like any action agency, EPA retains statutory 
authority to use appropriate information to make section 7(d) 
determinations under the ESA. In sum, the Services believe that it is 
advisable for the consultation process on these and other complex FIFRA 
actions to have flexibility, so that EPA and the Services can most 
efficiently and effectively protect listed species and habitats. EPA 
would only use the provision after conferring with the Service, which 
should further insure the continued effective and appropriate use of 
this authority.
    The proposed counterpart rule would make clear that the emergency 
consultation provisions in existing Service regulations are available 
to EPA for consultation on actions under FIFRA section 18 by providing 
that EPA could conduct consultation on actions involving requests for 
emergency exemptions under FIFRA section 18 under section 402.05 or 
another available consultation procedure. As provided in Sec. 402.05, 
any required formal consultation on such an action would have to be 
initiated as soon as practicable after the emergency is under control. 
For the purposes of the consultation required in Sec. 402.05(b), the 
definition of formal consultation in Sec. 402.02 would include the 
procedures in Sec. 402.46 in addition to those in Subpart B.
    The Services believe that EPA's statutory and regulatory standard 
for an ``emergency'' under FIFRA section 18 is generally comparable to 
the intended scope of emergency in Sec. 402.05 and that, therefore, the 
overwhelming majority of FIFRA emergency exemption actions could 
properly be considered emergencies for the purposes of Sec. 402.05. 
Under EPA regulations, FIFRA section 18 emergency exemptions can only 
be issued for urgent, non-routine situations where a pesticide is 
needed to address, for example, significant risks to human health or 
the environment or significant economic loss. 40 CFR 166.1(a), 
166.3(d). Pest problems of these dimensions would generally be 
encompassed within the provisions of Sec. 402.05(a).
    The Services' 1998 Joint Consultation Handbook (page 8-1) contains 
a passage suggesting that emergency actions under FIFRA may not usually 
qualify as emergencies ``unless there is a significant unexpected human 
health risk.'' While a significant unexpected human health risk would 
permit an emergency consultation under Sec. 402.05, the quoted passage 
should not be read to mean that the emergency provisions

[[Page 4475]]

in Sec. 402.05 are available for FIFRA section 18 actions only where an 
unexpected human health risk is present. Such a narrow reading of the 
quoted passage is inconsistent with other statements in the Handbook 
and with past Service practice in comparable circumstances. The plain 
language of Sec. 402.05 is not so limited, and can be read to encompass 
the kind of emergency situations that FIFRA section 18 contemplates 
even if no significant unexpected human health risk is present. The 
Services believe the use of Sec. 402.05 by EPA for FIFRA section 18 
actions under the proposed rule would therefore be consistent with 
practices currently permitted under Subpart B.
    The proposed counterpart rule contains other provisions to ensure 
full compliance with ESA requirements. After a consultation under this 
Subpart has been concluded, EPA shall reinitiate consultation as 
required by section 402.16 as soon as practicable after a circumstance 
requiring reinitiation occurs, and may employ the procedures in this 
Subpart or Subpart B in any reinitiated consultation. EPA must comply 
with section 402.15 for all FIFRA actions subject to consultation under 
this Subpart. EPA must prepare a biological assessment for FIFRA 
actions that constitute ``major construction activities'' to the extent 
required by section 402.12. The typical regulatory actions EPA takes 
under FIFRA (e.g., registration, reregistration, section 18 approvals) 
do not, however, generally constitute ``major construction 
activities,'' and the Services are not aware of any current FIFRA 
activities that would meet this definition. The proposed rule allows 
EPA to employ the conferencing procedures described in section 402.10 
for any species proposed for listing or any habitat proposed for 
designation as critical habitat, and provides that for the purposes of 
section 402.10(d), the procedures in section 402.46 would be a 
permissible form of formal consultation.

Public Comments Solicited

    We intend that any final action resulting from this proposal be as 
accurate and effective as possible. We are soliciting comments or 
suggestions from the public, other concerned governmental agencies, the 
scientific community, industry, or any other interested party 
concerning this proposed rule. Prior to making a final determination on 
this proposed rule, we will take into consideration all relevant 
comments and additional information received during the comment period.
    If you wish to comment, you may submit your comments by any one of 
several methods. You may mail comments to the address specified in 
ADDRESSES. You may also hand-deliver comments to the address specified 
in ADDRESSES. You may also comment via the Internet to 
[email protected]. Please submit Internet comments as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Please also include ``Attn: 1018-AI95'' and your name and 
return address in your Internet message. Our practice is to make 
comments, including names and home addresses of respondents, available 
for public review during regular business hours. Individual respondents 
may request that we withhold their home address from the rulemaking 
record, which we will honor to the extent allowable by law. There also 
may be circumstances in which we would withhold from the rulemaking 
record a respondent's identity, as allowable by law. If you wish us to 
withhold your name and/or address, you must state this prominently at 
the beginning of your comment. We will make all submissions from 
organizations or businesses, and from individuals identifying 
themselves as representatives of officials of organizations or 
businesses, available for public inspection in their entirety.

Required Determinations

Regulatory Planning and Review

    In accordance with Executive Order 12866, this document is a 
significant proposed rule because it may raise novel legal or policy 
issues, and was reviewed by the Office of Management and Budget (OMB) 
in accordance with the four criteria discussed below.
    (a) This counterpart regulation will not have an annual economic 
effect of $100 million or more or adversely affect an economic sector, 
productivity, jobs, the environment, or other units of government.
    (b) This counterpart regulation is not expected to create 
inconsistencies with other agencies' actions. FWS and NOAA Fisheries 
are responsible for carrying out the Act.
    (c) This counterpart regulation is not expected to significantly 
affect entitlements, grants, user fees, loan programs, or the rights 
and obligations of their recipients.
    (d) OMB has determined that this rule may raise novel legal or 
policy issues and, as a result, this rule has undergone OMB review.

Regulatory Flexibility Act (5 U.S.C. 601 et seq.)

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as 
amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA) of 1996), whenever an agency is required to publish a notice 
of rulemaking for any proposed or final rule, it must prepare and make 
available for public comment a regulatory flexibility analysis that 
describes the effect of the rule on small entities (i.e., small 
businesses, small organizations, and small government jurisdictions), 
unless the agency certifies that the rule will not have a significant 
economic impact on a substantial number of small entities. The 
Regulatory Flexibility Act requires Federal agencies to provide a 
statement of the factual basis for certifying that a rule will not have 
a significant economic impact on a substantial number of small 
entities.
    Pursuant to the Regulatory Flexibility Act, the Secretaries of the 
Interior and Commerce certify that this regulation will not have a 
significant economic impact on a substantial number of small entities. 
The purpose of the rule is to increase the efficiency of the ESA 
section 7 consultation process for those activities involving pesticide 
regulation conducted by EPA. The proposed changes are expected to lead 
to the same protections for listed species as the section 7 
consultation regulations at 50 CFR part 402.
    Regulations at 50 CFR 402.04 provide that ``the consultation 
procedures may be superseded for a particular Federal agency by joint 
counterpart regulations among that agency, the Fish and Wildlife 
Service, and the National Marine Fisheries Service.'' The preamble to 
the 1986 regulations for implementing section 7 states that ``such 
counterpart regulations must retain the overall degree of protection 
afforded listed species required by the [ESA] and these regulations. 
Changes in the general consultation process must be designed to enhance 
its efficiency without elimination of ultimate Federal agency 
responsibility for compliance with section 7.'' The proposed rule will 
not have a significant economic impact on a substantial number of small 
entities for the following reasons.
    (1) The proposed rule will modify procedures for formal section 7 
consultation and remove the requirement for EPA to conduct informal 
consultation with and obtain written concurrence from FWS or NOAA 
Fisheries on those FIFRA actions it determines are NLAA listed species 
or critical habitat.

[[Page 4476]]

    (2) The new consultation procedures may affect registrants, who 
provide EPA with the data used to assess the level of environmental 
risk. It is estimated that approximately two-thirds of the 1,850 
pesticide registrants are small businesses. Because this rule is 
expected to streamline the consultation process and would therefore 
potentially accelerate the registration process for new pesticide 
products pesticides and the re-registration process for existing 
pesticides, these businesses are expected to experience no effect or a 
small positive effect as a result of this rule.
    (3) Agricultural producers, many of which are small businesses, may 
be indirectly affected by this rule. Because this rule is expected to 
streamline the consultation process and would therefore potentially 
accelerate the registration process for new pesticide products 
pesticides and the re-registration process for existing pesticides, 
agricultural producers may experience a small indirect benefit from 
this rule.
    Therefore, the Secretaries of the Interior and Commerce certify 
that this action will not have a significant economic impact on a 
substantial number of small businesses, organizations, or governments 
pursuant to the RFA.

Executive Order 13211

    On May 18, 2001, the President issued an Executive Order (E.O. 
13211) on regulations that significantly affect energy supply, 
distribution, and use. Executive Order 13211 requires agencies to 
prepare Statements of Energy Effects when undertaking certain actions. 
Although this rule is a significant action under Executive Order 12866, 
it is not expected to significantly affect energy supplies, 
distribution, or use. Therefore, this action is not a significant 
energy action and no Statement of Energy Effects is required.

Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.)

    In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 
et seq.):
    (a) These counterpart regulations will not ``significantly or 
uniquely'' affect small governments. A Small Government Agency Plan is 
not required. We expect that these counterpart regulations will not 
result in any significant additional expenditures by entities that 
develop formalized conservation efforts.
    (b) These counterpart regulations will not produce a Federal 
mandate on State, local, or tribal governments or the private sector of 
$100 million or greater in any year; that is, it is not a ``significant 
regulatory action'' under the Unfunded Mandates Reform Act. These 
counterpart regulations impose no obligations on State, local, or 
tribal governments.

Takings

    In accordance with Executive Order 12630, these counterpart 
regulations do not have significant takings implications. These 
counterpart regulations pertain solely to ESA section 7 consultation 
coordination procedures, and the procedures have no impact on personal 
property rights.

Federalism

    In accordance with Executive Order 13132, these counterpart 
regulations do not have significant Federalism effects. A Federalism 
assessment is not required. In keeping with Department of the Interior 
and Commerce regulations under section 7 of the ESA, we coordinated 
development of these counterpart regulations with appropriate resource 
agencies throughout the United States.

Civil Justice Reform

    In accordance with Executive Order 12988, this proposed rule does 
not unduly burden the judicial system and meets the requirements of 
sections 3(a) and 3(b)(2) of the Order. We propose these counterpart 
regulations consistent with 50 CFR 402.04 and section 7 of the ESA.

Paperwork Reduction Act

    This proposed rule would not impose any new requirements for 
collection of information that require approval by the OMB under the 
Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This proposed rule 
will not impose new recordkeeping or reporting requirements on State or 
local governments, individuals, businesses, or organizations. We may 
not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
Control Number.

National Environmental Policy Act

    These counterpart regulations have been developed by FWS and NOAA 
Fisheries, along with EPA and USDA, according to 50 CFR 402.04. The FWS 
and NOAA Fisheries are considered the lead Federal agencies for the 
preparation of this proposed rule, pursuant to 40 CFR 1501. We have 
analyzed these counterpart regulations in accordance with the criteria 
of the National Environmental Policy Act (NEPA), the Department of the 
Interior Manual (318 DM 2.2(g) and 6.3(D)), and National Oceanic and 
Atmospheric Administration (NOAA) Administrative Order 216-6 and have 
determined that an environmental assessment will be prepared prior to 
finalization of the rule.

Government-to-Government Relationship With Indian Tribes

    In accordance with the Secretarial Order 3206, ``American Indian 
Tribal Rights, Federal-Tribal Trust Responsibilities, and the 
Endangered Species Act'' (June 5, 1997); the President's memorandum of 
April 29, 1994, ``Government-to-Government Relations with Native 
American Tribal Governments'' (59 FR 22951); E.O. 13175; and the 
Department of the Interior's 512 DM 2, we understand that we must 
relate to recognized Federal Indian Tribes on a Government-to-
Government basis. However, these counterpart regulations do not 
directly affect Tribal resources since only EPA regulatory actions are 
subject to the proposed provisions. The intent of these counterpart 
regulations is to streamline the consultation process; therefore, any 
indirect effect would be wholly beneficial.

List of Subjects in 50 CFR Part 402

    Endangered and threatened species.

Proposed Regulation Promulgation

    Accordingly the Services propose to amend part 402, title 50 of the 
Code of Federal Regulations as follows:

PART 402--[AMENDED]

    1. The authority citation for part 402 continues to read as 
follows:

    Authority: 16 U.S.C. 1531 et seq.

    2. Add a new Subpart D to read as follows:

Subpart D--Counterpart Regulations Governing Actions by the U.S. 
Environmental Protection Agency Under the Federal Insecticide, 
Fungicide and Rodenticide Act

Sec.
402.40 Definitions.
402.41 Purpose.
402.42 Scope and applicability
402.43 Interagency exchanges of information.
402.44 Advance coordination for FIFRA actions.
402.45 Alternative consultation on FIFRA actions that are not likely 
to adversely affect listed species or critical habitat.
402.46 Optional formal consultation procedure for FIFRA actions.
402.47 Special consultation procedures for complex FIFRA actions.

[[Page 4477]]

402.48 Conference on proposed species or proposed critical habitat.

Subpart D--Counterpart Regulations Governing Actions by the U.S. 
Environmental Protection Agency Under the Federal Insecticide, 
Fungicide and Rodenticide Act


Sec. 402.40  Definitions.

    The definitions in Sec. 402.02 are applicable to this subpart. In 
addition, the following definitions are applicable only to this 
subpart.
    (a) Alternative consultation agreement is the agreement described 
in Sec. 402.45.
    (b) Effects determination is a written determination by the U.S. 
Environmental Protection Agency (EPA) addressing the effects of a FIFRA 
action on listed species or critical habitat. The contents of an 
effects determination will depend on the nature of the action. An 
effects determination submitted under Sec. 402.46 or Sec. 402.47 shall 
contain the information described in Sec. 402.14(c)(1)-(6) and a 
summary of the information on which the determination is based, 
detailing how the FIFRA action affects the listed species or critical 
habitat. EPA may consider the following additional sections for 
inclusion in an effects determination:
    (1) A conclusion whether or not the FIFRA action is likely to 
jeopardize the continued existence of any listed species or result in 
the destruction or adverse modification of critical habitat and a 
description of any reasonable and prudent alternatives that may be 
available;
    (2) A description of the impact of any anticipated incidental 
taking of such listed species resulting from the FIFRA action, 
reasonable and prudent measures considered necessary or appropriate to 
minimize such impact, and terms and conditions necessary to implement 
such measures; and
    (3) A summary of any information or recommendations from an 
applicant. An effects determination shall be based on the best 
scientific and commercial data available.
    (c) FIFRA action is an action by EPA to approve, permit or 
authorize the sale, distribution or use of a pesticide under sections 
136-136y of the Federal Insecticide, Fungicide and Rodenticide Act, 7 
U.S.C. 136 et seq. (FIFRA). In any consultation under this subpart, EPA 
shall determine the nature and scope of a FIFRA action.
    (d) Listed species is a species listed as endangered or threatened 
under section 4 of the Act.
    (e) Partial biological opinion is the document provided under Sec. 
402.47(a), pending the conclusion of consultation under Sec. 402.47(b), 
stating the opinion of the Service as to whether or not a FIFRA action 
is likely to jeopardize the continued existence of one or more listed 
species or result in the destruction or adverse modification of one or 
more critical habitats, and describing the impact of any anticipated 
incidental taking of such listed species resulting from the FIFRA 
action, reasonable and prudent measures considered necessary or 
appropriate to minimize such impact, and terms and conditions necessary 
to implement such measures.
    (f) Service Director refers to the Director of the U.S. Fish and 
Wildlife Service or the Assistant Administrator for Fisheries for the 
National Oceanic and Atmospheric Administration.
    (g) Service Representative is the person or persons designated to 
participate in advance coordination as provided in this subpart. The 
Service may designate more than one individual to serve jointly as a 
Service Representative.


Sec. 402.41  Purpose.

    The purpose of these counterpart regulations is to enhance the 
efficiency and effectiveness of the existing consultation process under 
section 7 of the Endangered Species Act (Act), 16 U.S.C. 1531 et seq., 
by providing Fish and Wildlife Service and the National Marine 
Fisheries Service (referred to jointly as ``Services'' and individually 
as ``Service'') and EPA with additional means to satisfy the 
requirements of section 7(a)(2) of the Act for certain regulatory 
actions under FIFRA. These additional means will permit the Services 
and EPA to more effectively use the scientific and commercial data 
generated through the FIFRA regulatory process as part of the best 
scientific and commercial data available to protect listed species and 
critical habitat. The procedures authorized by these counterpart 
regulations will be as protective of listed species and critical 
habitat as the process established in subpart B of this part.


Sec. 402.42  Scope and applicability.

    (a) Available consultation procedures. This Subpart describes 
consultation procedures available to EPA to satisfy the obligations of 
section 7(a)(2) of the Act in addition to those in subpart B of this 
part for FIFRA actions authorized, funded, or carried out by EPA in 
which EPA has discretionary Federal involvement or control. EPA retains 
discretion to initiate early, informal, or formal consultation as 
described in Sec.Sec. 402.11, 402.13, and 402.14 for any FIFRA action. 
The procedures in this Subpart may be employed for FIFRA actions as 
follows:
    (1) Interagency exchanges of information under Sec. 402.43 and 
advance coordination under Sec. 402.44 are available for any FIFRA 
action.
    (2) Alternative consultation under Sec. 402.45 is available for a 
listed species or critical habitat if EPA determines the FIFRA action 
is not likely to adversely affect the listed species or critical 
habitat.
    (3) Optional formal consultation under Sec. 402.46 is available for 
any FIFRA action with respect to any listed species or critical 
habitat.
    (4) The special procedures in Sec. 402.47 are available for 
consultations on FIFRA actions that will be unusually complex due to 
factors such as the geographic area or number of species that may be 
affected by the action.
    (5) EPA shall engage in consultation as to all listed species and 
critical habitat that may be affected by a FIFRA action, and may in its 
discretion employ more than one of the available consultation 
procedures for a FIFRA action that may affect more than one listed 
species or critical habitat.
    (6) EPA shall engage in consultation on actions involving requests 
for emergency exemptions under section 18 of FIFRA that may affect 
listed species or critical habitat, and may choose to do so under Sec. 
402.05 or other provisions of this subpart or subpart B of this part. 
Any required formal consultation shall be initiated as soon as 
practicable after the emergency is under control. For the purposes of 
Sec. 402.05(b) the definition of formal consultation in Sec. 402.02 
includes the procedures in Sec. 402.46.
    (7) EPA must prepare a biological assessment for a FIFRA action to 
the extent required by Sec. 402.12.
    (8) EPA must comply with Sec. 402.15 for all FIFRA actions.
    (9) After a consultation under this subpart has been concluded, EPA 
shall reinitiate consultation as required by Sec. 402.16 as soon as 
practicable after a circumstance requiring reinitiation occurs, and may 
employ the procedures in this subpart or subpart B of this part in any 
reinitiated consultation.
    (b) Exchanges of scientific information. As part of any of the 
additional consultation procedures provided in this subpart, EPA and 
the Services shall establish mutually-agreeable procedures for regular 
and timely exchanges of scientific information to achieve accurate and 
informed decision-making under this subpart and to ensure that the 
FIFRA process considers the best scientific and commercial data 
available on listed species and critical habitat in a manner

[[Page 4478]]

consistent with the requirements of FIFRA and ESA.


Sec. 402.43  Interagency exchanges of information.

    EPA may convey to the Service a written request for a list of any 
listed species or critical habitat that may be present in any area that 
may be affected by a FIFRA action. Within 30 days of receipt of such a 
request the Service shall advise EPA in writing whether, based on the 
best scientific and commercial data available, any listed species or 
critical habitat may be present in any such area. EPA may thereafter 
request the Service to provide available information (or references 
thereto) describing the applicable environmental baseline for each 
species or habitat that EPA determines may be affected by a FIFRA 
action, and the Service shall provide such information within 30 days 
of the request.


Sec. 402.44  Advance coordination for FIFRA actions.

    (a) Advance coordination. EPA may request the Service to designate 
a Service Representative to work with EPA in the development of an 
effects determination for one or more listed species or critical 
habitat. EPA shall make such a request in writing and shall provide 
sufficient detail as to a FIFRA action planned for consultation to 
enable the Service to designate a representative with appropriate 
training and experience who shall normally be available to complete 
advance coordination with EPA within 60 days of the date of 
designation. Within 14 days of receiving such a request, the Service 
shall advise EPA of the designated Service Representative.
    (b) Participation of Service Representative in preparation of 
effects determination. The Service Representative designated under 
paragraph (a) of this section shall participate with EPA staff in the 
preparation of the effects determination identified under paragraph (a) 
of this section. EPA shall use its best efforts to include the 
designated Service Representative in all relevant discussions on the 
effects determination, to provide the designated Service Representative 
with access to all documentation used to prepare the effects 
determination, and to provide the designated Service Representative 
office and staff support sufficient to allow the Service Representative 
to participate meaningfully in the preparation of the effects 
determination. EPA shall consider all information timely identified by 
the designated Service Representative during the preparation of the 
effects determination.


Sec. 402.45  Alternative consultation on FIFRA actions that are not 
likely to adversely affect listed species or critical habitat.

    (a) Consultation obligations for FIFRA actions that are not likely 
to adversely affect listed species or critical habitat when alternative 
consultation agreement is in effect. If EPA and the Service have 
entered into an alternative consultation agreement as provided below, 
EPA may make a determination that a FIFRA action is not likely to 
adversely affect a listed species or critical habitat without informal 
consultation or written concurrence from the Director, and upon making 
such a determination for a listed species or critical habitat, EPA need 
not initiate any additional consultation on that FIFRA action as to 
that listed species or critical habitat. As part of any subsequent 
request for formal consultation on that FIFRA action under this subpart 
or subpart B of this part, EPA shall include a list of all listed 
species and critical habitat for which EPA has concluded consultation 
under this section.
    (b) Procedures for adopting and implementing an alternative 
consultation agreement. EPA and the Service may enter into an 
alternative consultation agreement using the following procedures:
    (1) Initiation. EPA submits a written notification to the Service 
Director of its intent to enter into an alternative consultation 
agreement.
    (2) Required contents of the alternative consultation agreement. 
The alternative consultation agreement will, at a minimum, include the 
following components:
    (i) Adequacy of EPA Determinations under the ESA. The alternative 
consultation agreement shall describe actions that EPA and the Service 
have taken to ensure that EPA's determinations regarding the effects of 
its actions on listed species or critical habitat are consistent with 
the ESA and applicable implementing regulations.
    (ii) Training. The alternative consultation agreement shall 
describe actions that EPA and the Service intend to take to ensure that 
EPA and Service personnel are adequately trained to carry out their 
respective roles under the alternative consultation agreement. The 
alternative consultation agreement shall provide that all effects 
determinations made by EPA under this Subpart have been reviewed and 
concurred on by an EPA staff member who holds a current certification 
as having received appropriate training under the alternative 
consultation agreement.
    (iii) Incorporation of new information. The alternative 
consultation agreement shall describe processes that EPA and the 
Service intend use to ensure that new information relevant to EPA's 
effects determinations is timely and appropriately considered.
    (iv) Incorporation of scientific advances. The alternative 
consultation agreement shall describe processes that EPA and the 
Service intend to use to ensure that the ecological risk assessment 
methodologies supporting EPA's effects determinations incorporate 
relevant scientific advances.
    (v) Oversight. The alternative consultation agreement shall 
describe the program and associated record keeping procedures that the 
Service and EPA intend to use to evaluate EPA's processes for making 
effects determinations consistent with these regulations and the 
alternative consultation agreement. The alternative consultation 
agreement shall provide that the Service's oversight will be based on 
periodic evaluation of EPA's program for making effects determinations 
under this Subpart. Periodic program evaluation will occur at the end 
of the first year following signature of the alternative consultation 
agreement and should normally occur at least every five years 
thereafter.
    (vi) Records. The alternative consultation agreement shall include 
a provision for EPA to maintain a list of FIFRA actions for which EPA 
has made determinations under this section and to provide the list to 
the Services on request. EPA will also maintain the necessary records 
to allow the Service to complete program evaluations.
    (vii) Review of Alternative Consultation Agreement. The alternative 
consultation agreement shall include provisions for regular review and, 
as appropriate, modification of the agreement by EPA and the Service, 
and for departure from its terms in a particular case to the extent 
deemed necessary by both EPA and the Service.
    (3) Training. After EPA and the Service enter into the alternative 
consultation agreement, EPA and the Service will implement the training 
program outlined in the alternative consultation agreement to the 
mutual satisfaction of EPA and the Service.
    (4) Public availability. The alternative consultation agreement and 
any related oversight or monitoring reports shall be made available to 
the public to the extent provided by law.
    (c) Oversight of alternative consultation agreement implementation. 
Through the program

[[Page 4479]]

evaluations set forth in the alternative consultation agreement, the 
Service will determine whether the implementation of this section by 
EPA is consistent with the best scientific and commercial information 
available, the ESA, and applicable implementing regulations. The 
Service Director may use the results of the program evaluations 
described in the alternative consultation agreement to recommend 
changes to EPA's implementation of the alternative consultation 
agreement. The Service Director retains discretion to terminate the 
alternative consultation agreement if, in using the procedures in this 
subpart, EPA fails to comply with the requirements of this subpart, 
section 7 of the ESA, or the terms of the alternative consultation 
agreement. Termination, suspension, or modification of an alternative 
consultation agreement does not affect the validity of any NLAA 
determinations made previously under the authority of this Subpart.


Sec. 402.46  Optional formal consultation procedure for FIFRA actions.

    (a) Initiation of consultation. EPA may initiate consultation on a 
FIFRA action under this section by delivering to the Service a written 
request for consultation. The written request shall be accompanied by 
an effects determination prepared in accordance with Sec. 402.40(b) and 
a list or summary of all references and data relied upon in the 
determination. All such references and data shall be made available to 
the Service on request and shall constitute part of the Service's 
administrative record for the consultation. The time for conclusion of 
the consultation under section 7(b)(1) of the Act is calculated from 
the date the Service receives the written request from EPA. Any 
subsequent interchanges regarding EPA's submission, including 
interchanges about the completeness of the effects determination, shall 
occur during consultation and do not extend the time for conclusion of 
the consultation unless EPA withdraws the request for consultation.
    (b) Additional information determination. For an effects 
determination prepared without advance coordination under Sec. 402.44, 
the Service may determine that additional available information would 
provide a better information base for the effects determination, in 
which case the Service Director shall notify the EPA Administrator 
within 45 days of the date the Service receives the effects 
determination. The notification shall describe such additional 
information in detail, and shall identify a means for obtaining that 
information within the time period available for consultation. EPA 
shall provide a copy of the Service Director's notification to any 
applicant. EPA may thereafter revise its effects determination, and may 
resubmit the revised effects determination to the Service. If EPA 
advises the Service it will not resubmit a revised effects 
determination to the Service, its initiation of consultation on the 
effects determination is deemed withdrawn.
    (c) Service responsibilities. (1) Within the later of 90 days of 
the date the Service receives EPA's written request for consultation or 
45 days of the date the Service receives an effects determination 
resubmitted under paragraph (b) of this section, and consistent with 
section 7(b)(1) of the Act, the Service shall take one of the following 
actions:
    (i) If the Service finds that the effects determination contains 
the information required by Sec. 402.40(b) and satisfies the 
requirements of section 7(b)(4) of the Act, and the Service concludes 
that the FIFRA action that is the subject of the consultation complies 
with section 7(a)(2) of the Act, the Service will issue a written 
statement adopting the effects determination; or
    (ii) The Service will provide EPA a draft of a written statement 
modifying the effects determination, which shall meet the requirements 
of Sec. 402.14(i), and as modified adopting the effects determination, 
and shall provide a detailed explanation of the scientific and 
commercial data and rationale supporting any modification it makes; or
    (iii) The Service will provide EPA a draft of a biological opinion 
finding that the FIFRA action is likely to jeopardize the continued 
existence of a listed species or result in the destruction or adverse 
modification of critical habitat, and describing any reasonable and 
prudent alternatives if available.
    (2) If the Service acts under paragraphs (c)(1)(ii) or (c)(1)(iii) 
of this section, EPA shall, on request from an applicant, provide the 
applicant a copy of the draft written statement or draft biological 
opinion received from the Service. The Service shall at the request of 
EPA or an applicant discuss with EPA and the applicant the Service's 
review and evaluation under this section, and the basis for its 
findings. EPA and any applicant may submit written comments to the 
Service within 30 days after EPA receives the draft written statement 
or opinion from the Service unless the Service, EPA and any applicant 
agree to an extended deadline consistent with section 7(b)(1) of the 
Act.
    (3) The Service will issue a final written statement or final 
biological opinion within 45 days after EPA receives the draft 
statement or opinion from the Service unless the deadline is extended 
under section 7(b)(1) of the Act.
    (d) Opinion of the Secretary. The written statement or opinion by 
the Service under paragraphs (c)(1) or (c)(3) of this section shall 
constitute the opinion of the Secretary and the incidental take 
statement, reasonable and prudent measures, and terms and conditions 
under section 7(b) of the Act.
    (e) Delegation of Authority for Service decisions. Any written 
statement modifying an effects determination or any biological opinion 
issued under this section shall be signed by the Service Director and 
such authority may not be delegated below the level of Assistant 
Director for Endangered Species (FWS) or Director of Office of 
Protected Resources (NOAA Fisheries).


Sec. 402.47  Special consultation procedures for complex FIFRA actions.

    (a) Successive effects determinations. If EPA determines after 
conferring with the Service that consultation on a FIFRA action will be 
unusually complex due to factors such as the geographic area or number 
of species that may be affected by the action, EPA may address the 
effects of the action through successive effects determinations under 
this Subpart addressing groupings or categories of species or habitats 
as established by EPA. EPA may initiate consultation based upon each 
such effects determination using the procedure in Sec. 402.46(a), and 
the provisions of Sec. 402.46(b) and (c) shall apply to any such 
consultation. When consultation is conducted under this section, the 
written statement or opinion provided by the Service under Sec. 
402.46(c) constitutes a partial biological opinion as to the species or 
habitats that are the subject of the consultation. While not 
constituting completion of consultation under section 7(a)(2), EPA 
retains authority to use such a partial biological opinion along with 
other available information in making a finding under section 7(d) of 
the Act.
    (b) Opinion of the Secretary. After conclusion of all consultation 
on the FIFRA action, the partial biological opinions issued under 
paragraph (a) of this section shall then collectively constitute the 
opinion of the Secretary and the incidental take statement, reasonable 
and prudent measures, and terms and conditions under section 7(b) of 
the Act except to the extent a partial biological opinion is modified 
by the

[[Page 4480]]

Service in accordance with the procedures in Sec. 402.46(c). The 
Service shall so advise EPA in writing upon issuance of the last 
partial biological opinion for the consultation.


Sec. 402.48  Conference on proposed species or proposed critical 
habitat.

    EPA may employ the procedures described in Sec. 402.10 to confer on 
any species proposed for listing or any habitat proposed for 
designation as critical habitat. For the purposes of Sec. 402.10(d), 
the procedures in Sec. 402.46 are a permissible form of formal 
consultation.

    Dated: January 27, 2004.
Paul Hoffman,
Acting Assistant Secretary for Fish and Wildlife and Parks.
    Dated: January 26, 2004.
William T. Hogarth,
Assistant Administrator for Fisheries, National Oceanic and Atmospheric 
Administration.
[FR Doc. 04-1963 Filed 1-28-04; 10:11 am]
BILLING CODE 4310-55-P