[Federal Register Volume 69, Number 150 (Thursday, August 5, 2004)]
[Rules and Regulations]
[Pages 47732-47762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17654]



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Part III





Department of the Interior





Fish and Wildlife Service



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Department of Commerce





National Oceanic and Atmospheric Administration



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50 CFR Part 402



Joint Counterpart Endangered Species Act Section 7 Consultation 
Regulations; Final Rule

  Federal Register / Vol. 69, No. 150 / Thursday, August 5, 2004 / 
Rules and Regulations  

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DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

RIN 1018-AI95

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

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: Final rule.

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SUMMARY: This final rule, developed by 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), codifies joint counterpart regulations for 
consultation under section 7 of the Endangered Species Act of 1973, as 
amended (16 U.S.C. 1531 et seq.) (ESA), for regulatory actions under 
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). 
Counterpart regulations, described in general terms in part 402, 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 section 7 consultation process described in subparts A and B of 
the same part. These counterpart regulations enhance the efficiency and 
effectiveness of the section 7 consultation process by increasing 
interagency cooperation and providing two optional alternatives for 
completing section 7 consultation for FIFRA regulatory actions. One 
alternative modifies the process for EPA to conduct informal 
consultation with the Service for those FIFRA actions that EPA 
determines are ``not likely to adversely affect'' any federally-
protected threatened and endangered species (``listed species'') or 
critical habitat. The other alternative permits 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 listed species and critical habitats.

DATES: This rule is effective September 7, 2004.

ADDRESSES: The complete file for this rule is available for inspection, 
by appointment, during normal business hours at the Division of 
Consultation, Habitat Conservation Planning, Recovery and State Grants, 
U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 420, 
Arlington, Virginia 22203.

FOR FURTHER INFORMATION CONTACT: Patrick Leonard, Chief, Division of 
Consultation, Habitat Conservation Planning, Recovery and State Grants, 
at the above address (Telephone 703/358-2171, Facsimile 703/358-1735) 
or Jim Lecky, Acting Senior Advisor for Intergovernmental Programs, 
NOAA Fisheries, 1315 East-West Highway, Silver Spring, MD 20910 (301/
713-2239; facsimile 301/713-1940).

SUPPLEMENTARY INFORMATION: Through this final joint rulemaking, the FWS 
and NOAA adopt additional 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 Final Rulemaking, developed with assistance 
from EPA and the USDA, complements the Services' other 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 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, 
including many of the documents mentioned in this Notice, 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 to protect 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 (subparts A and B). 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 subparts A and B, the consultation process reviews a variety 
of

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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. 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 section 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

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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 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 pesticide ``when used in 
accordance with widespread and commonly recognized practice, 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(1).
    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 Document'') (January 2004), and in documents 
referenced in that paper, all of which are part of the administrative 
record of this final rule. 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 Document. 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

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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 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 
Document and the materials referenced therein. Based on this review, 
the Services have determined that the approach used by EPA 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. Reasons for a Counterpart Regulation for EPA Pesticide Actions

    Rationale for the rule as finalized. In developing a process for 
conducting future ESA consultations on FIFRA pesticide regulatory 
actions, the Services and EPA recognized that EPA possesses, 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

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may pose to non-target fish, wildlife, and plant (``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 species in many different locations throughout the 
country may be affected by such use. This broad scope of intended use 
of the 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 
was 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 
is intended to 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 provided strong reasons for the Services to establish 
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 will 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 that would allow 
EPA to make decisions more quickly, and therefore allow such new 
products in the market sooner, should generally 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 will be achieved in a way that avoids unnecessary burdens 
on pesticide users with no sacrifice to the protection of listed 
species.

5. The Counterpart Regulations

    These counterpart regulations 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 rule offers an alternative approach when EPA determines 
that a FIFRA action is not likely to cause adverse effects on listed 
species or critical habitat, and an 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

    This counterpart rule establishes 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

[[Page 47737]]

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 
Listed Species or Habitats

    The section 7 regulations in subpart B 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 process contained in Sec.  402.45 of 
these counterpart regulations 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 consultation 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 regulation will require the 
Service and EPA to have in effect an alternative consultation agreement 
before EPA can utilize the procedures of Sec.  402.45, the alternative 
consultation agreement itself is not part of this rule, and the 
Services have concluded that the alternative consultation agreement 
will 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 Sec.  402.45(b), the required content of the alternative 
consultation agreement includes 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 Services' discretion in 
developing and applying scientific methodologies. The alternative 
consultation agreement will be expected to undergo continuous 
modification and improvement. EPA and the Service will 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 will 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 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 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 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 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 outlined 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 counterpart regulations it will retain full responsibility 
for compliance with section 7 of the ESA.
    Under this rule, EPA will 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 will fulfill its ESA section 7 consultation 
responsibility for actions covered under these 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 under 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

[[Page 47738]]

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, modification, or termination will not affect the legal 
validity of determinations made prior to the suspension, modification, 
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 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 rule, and was made available for the 
public to read to obtain a better understanding of how the Services 
anticipate the requirements of Sec.  402.45 would be satisfied.

C. New Optional Formal Consultation Process

    The counterpart regulations establish a new formal consultation 
process (Sec.  402.46) that will meet all statutory requirements and 
closely follow the procedural steps specified in the current subpart B 
process. The new process will 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 will 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 will depend on the 
nature of the action, an effects determination submitted under Sec.  
402.46 or Sec.  402.47 will 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 will 
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 will be accompanied by an 
effects determination as defined in 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 will 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, 
will occur during consultation, and will 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 will 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 will 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 other consultation procedures in Part 
402. 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

[[Page 47739]]

determination or draft jeopardy opinion, EPA is required to make it 
available to any applicant upon request. The rule also accommodates 
EPA's existing discretion to make these draft documents available to 
the general public for comment within the time periods provided in this 
rule. The Service will 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 will 
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.
    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 will use this provision after 
conferring with the Services, and EPA and the Services intend to 
collaboratively identify priorities where use of this provision will 
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) will apply to 
the consultation. The written statement or opinion provided by the 
Service under Sec.  402.46(c) will 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 will 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 will 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 will 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. Rather, for certain complex FIFRA actions the provision 
strengthens 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 will not satisfy its procedural obligations under section 
7(a)(2) of the ESA until all necessary consultations are completed. 
Likewise, a Service's issuance of a partial biological opinion 
following each such focused consultation will not represent the opinion 
of the Secretary or an incidental take statement under section 7(b) of 
the ESA until all required consultation is concluded on listed species 
and habitats.
    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 
will only use the provision after conferring with the Service, which 
should further insure the continued effective and appropriate use of 
this authority.
    This counterpart rule makes 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 will 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 will 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

[[Page 47740]]

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 will 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 will 
permit an emergency consultation under Sec.  402.05, the quoted passage 
should not be read to mean that the emergency provisions 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 this rule will therefore be consistent with 
practices currently permitted under subpart B.
    The 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 Sec.  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 Sec.  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 Sec.  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. This rule allows EPA to 
employ the conferencing procedures described in Sec.  402.10 for any 
species proposed for listing or any habitat proposed for designation as 
critical habitat, and provides that for the purposes of Sec.  
402.10(d), the procedures in Sec.  402.46 would be a permissible form 
of formal consultation.

Summary of Comments Received

    On January 30, 2004, the Services proposed the rule that would 
establish joint counterpart regulations for consultation under section 
7 of the ESA to streamline consultation on proposed actions under 
FIFRA. The comment period was to close on March 30, 2004 but was 
extended to April 16, 2004. The Services received more than 125,000 
comments on the proposed rule from a large variety of entities, 
including States, agricultural entities, trade associations, industry, 
conservation groups, coalitions, and private individuals. The 
overwhelming majority of comments received were part of letter-writing 
and e-mail campaigns expressing, in a ratio of approximately 1:2, 
general support for or opposition to the proposal. The Services 
considered all of the information and recommendations received from all 
interested parties on the proposed regulations during the public 
comment period and appreciated the comments received on the proposed 
rule. The Services received numerous comments on the ACA, the Overview 
Document and other materials included in the rulemaking record that are 
neither part of the proposed counterpart regulations nor incorporated 
by reference into the regulations. Since these documents are not part 
of the regulations, the Services have only responded to them to the 
extent that the comments on these documents relate to the proposal to 
adopt the counterpart regulations.
    The following is a summary of the comments received on the proposed 
counterpart regulations, and the Services' responses.

General Comments

    Comment: The proposed rule should be withdrawn and the Services 
should instead enforce existing consultation rules.
    Response: The Services believe that the counterpart regulations 
will complement the existing section 7 consultation process and 
therefore are promulgating the final rule.
    Comment: The proposed counterpart regulations are an improvement 
over the current process and will: improve coordination of FIFRA 
actions and ESA evaluations; increase the speed and efficiency by which 
steps can be taken to protect species and/or their habitat; and improve 
the consistency of endangered species assessments for FIFRA-regulated 
products.
    Response: The Services agree with these comments.
    Comment: Several elements of the proposed rule were particularly 
impressive: clarification of the mechanisms by which the Services will 
get information to EPA on a timely basis; recognition that, in many 
cases, it is sensible for EPA to proceed with consultations on a phased 
basis; and confirmation that EPA retains authority to make section 7(d) 
decisions regarding pesticide impacts.
    Response: The Services appreciate these comments.
    Comment: The consultation process between the Environmental 
Protection Agency (EPA) and the Services should be strengthened.
    Response: The Services agree that the section 7 consultation 
process with EPA should be strengthened. The intent of the rule is to 
enhance the efficiency and effectiveness of the consultation process 
through increased interagency cooperation.
    Comment: There is no need to change the current consultation 
process system. In fact, there is inadequate justification for doing 
so. For the public to assess the need for the counterpart regulations, 
the document should include numbers of how many FIFRA actions resulted 
in ``no effect'', ``not likely to adversely affect'', and formal 
consultation, rather than simply how many FIFRA registrations take 
place. Instead of changing the rules, the Services and EPA should work 
to improve the existing process, and work with wildlife experts. 
Moreover, any efficiencies of time that might be gained are 
unnecessary, because the FIFRA registration process can take years and 
is compatible with the timeframes in section 7.
    Response: The Services do not believe past practices are an 
indication of the future, and moreover it is difficult to foresee 
accurately how many FIFRA actions will need to undergo consultation. 
Nonetheless, the Services, EPA and the Department of Agriculture all 
agree that the number of consultations on FIFRA actions likely in 
coming years is so great that the Services could not complete the 
consultations under the existing processes and meet their other ESA 
duties in a timely manner with existing resources. The Services do not 
want to wait until the workload has already become too great before 
implementing the means to manage the workload more efficiently, and are 
taking the proactive step of adopting the counterpart regulations at 
this time. The Services

[[Page 47741]]

note that the counterpart regulations do not change the timeframes in 
section 7.
    Comment: The proposed rule will favor the pesticide industry and is 
therefore not in the public interest.
    Response: The Services disagree with this comment. The counterpart 
regulations will enable EPA and the Services to fully protect 
endangered species and will enable EPA to provide pesticide users the 
products they require to meet the needs of the American people.
    Comment: Public Law 100-478 did more than express Congressional 
intent; it also established the goals of EPA's pesticide labeling 
program, including allowing persons to continue the production of 
agricultural food and fiber commodities and minimizing the impacts to 
persons engaged in agricultural food and fiber commodity production and 
other affected pesticide users and applicators.
    Response: These counterpart regulations are intended to provide 
flexibility to EPA under the ESA by creating optional alternative 
procedures to the existing subpart B consultation process consistent 
with the goals of Public Law 100-478. These counterpart regulations 
will enhance the efficiency and effectiveness of the subpart B 
consultation process by increasing interagency cooperation and 
providing two optional alternatives for EPA's pesticide registration 
program. By providing EPA with more flexibility, impacts to persons 
engaged in agricultural food and fiber commodity production and other 
affected pesticide users and applicators will be minimized.
    Comment: Pesticides are a source of risk to listed species and 
threaten their survival and recovery. Several commenters noted that 
pesticides have been found to disrupt the normal functions of immune 
and endocrine systems of various wildlife species, and even newer 
pesticides are still highly toxic. Another commenter provided the 
opposing view that, through EPA's registration process and voluntary 
withdrawals, the number of available pesticides has been greatly 
reduced, and the remaining pesticides are more pest-specific and less 
environmentally hazardous.
    Response: The Services agree that some pesticide uses have the 
potential to affect listed species and critical habitat. These 
regulations are designed to assist EPA and the Services in evaluating 
these potential effects.
    Comment: Pesticides are necessary in order to manage and control 
invasive plants, which otherwise degrade critical habitat and endanger 
susceptible species. Executive Order 13112 on Invasive Species requires 
all Federal agencies to identify agency action that may contribute to 
the spread of invasive species and to address the invasive species 
problem to the extent practical and consistent with their authorities 
and resources. Use of pesticides has reduced farms' footprints, 
improved soil conservation, and benefited wildlife.
    Response: The Services agree that invasive species can be a threat 
to listed species, and recognize that use of pesticides can be 
beneficial, including the possibility of use to control invasive 
species. This Executive Order, however, does not relieve a federal 
agency from its obligations under section 7 of the ESA for its actions, 
including those for the purpose of controlling invasive species.
    Comment: Pesticides should be banned in areas inhabited by listed 
species, except when licensed individuals are controlling invasive 
species that threaten native wildlife. Another commenter took an 
opposing position, suggesting that in certain circumstances `` for 
example, when a crop grows in close proximity to another crop for which 
pesticide use has been authorized `` a minimum level of pesticide use 
should be allowed without completing consultation. Yet another 
commenter suggested that the use of national standards for the 
protection of listed species frequently do not work due to the variety 
of special local circumstances.
    Response: The Services consider these comments beyond the scope of 
the counterpart regulations, as we do not have the authority to 
generally ban the use of pesticides, nor do we have authority to 
authorize use of a pesticide. The Services note that, through the 
consultation process, the Services may recommend to EPA a wide range of 
measures to address identified effects to listed species caused by the 
use of pesticides, which may be tailored to local conditions.
    Comment: Only 1 percent of pesticides reach their targets. There 
are other methods to promote successful agriculture that do not involve 
extensive pesticide use. EPA needs to give more than lip service to the 
identification of non-toxic alternatives.
    Response: The Services understand that there are circumstances 
under which EPA considers non-toxic alternatives under FIFRA; however, 
the counterpart regulations will apply to EPA's consultation obligation 
with respect to FIFRA actions and do not address EPA's responsibilities 
under FIFRA. These counterpart regulations do not limit the ability of 
EPA to explore alternatives to the action that is subject to 
consultation.
    Comment: The counterpart regulations do not provide the same 
overall degree of protection for listed species as the existing 
consultation rules in subpart B. If EPA is not required to obtain a 
written concurrence from the Services concerning its NLAA 
determinations, the Services will lose the opportunity to identify data 
gaps, additional studies, or mitigation measures.
    Response: The Services disagree with this comment. The procedures 
authorized by these counterpart regulations will be as protective of 
listed species and critical habitat as the process established in 
subpart B. All consultations under the counterpart regulations will 
apply the same legal and biological standards as consultations under 
subpart B. The counterpart regulations merely provide an alternate 
process for meeting these procedural standards. The Services note that 
EPA would still have the option of involving the Service Representative 
to assist with development of effects determinations to identify data 
gaps, additional studies, or mitigation measures. Most important, 
through their review of EPA's ecological risk assessment approach, the 
Services have concluded the EPA's approach should produce effects 
determinations that appropriately identify actions that are not likely 
to adversely affect listed species or critical habitat, and with which 
the Services would likely concur.
    Comment: The proposed counterpart regulations organize the 
consultation process. Such an organized process is favored over the 
unpredictability of litigation. Another commenter expressed the 
opposing point of view that reducing the Services' review of pesticide 
actions could increase litigation against EPA, because EPA would not 
enjoy the same deference to its risk assessments as the Services would 
receive, and therefore the FIFRA registrations may actually be delayed.
    Response: The Services agree that a carefully structured 
consultation process is preferable to the unpredictability of 
litigation. While the Services cannot control litigation decisions made 
by the public, we do not believe that these counterpart regulations 
increase EPA's legal vulnerability under the ESA or change judicial 
review standards, and therefore predicted delays due to litigation 
would be a matter of speculation.
    Comment: A primary purpose of the counterpart regulations must be 
to alleviate the threat of civil and criminal penalties under the ESA 
associated with

[[Page 47742]]

the pesticide use that has resulted from the lack of a final FIFRA 
endangered species program. The counterpart regulations must help 
ensure a timely and efficient pesticide registration process in 
addition to protection of listed species and their habitats.
    Response: The proposed counterpart regulations will improve the 
effectiveness and efficiency of the consultation process for 
pesticides, which will result in more expeditious EPA determinations of 
NLAA and Service determinations regarding the authorization of 
incidental ``take'' of listed species, including any reasonable and 
prudent measures that are necessary or appropriate to minimize the 
impacts of such ``take.'' These regulations will also help ensure that 
registration and reregistration decisions for which ESA determinations 
must be made are completed in a timely manner. As a result, the 
counterpart regulations will improve upon EPA's ability to ensure that 
pesticide use directions are consistent with the requirements of the 
ESA and that users properly following pesticide use instructions are 
not at a theoretical risk of prosecution under the ESA.
    Comment: Several commenters suggested that the provisions in Sec.  
402.45 for informal consultation on actions that are not likely to 
adversely affect listed species or critical habitat are not consistent 
with the legal requirements of the ESA. Commenters suggested that the 
ESA requires the Services to conduct a formal consultation on any FIFRA 
action: (1) That may affect a listed species (citing a 1978 
congressional report on ESA amendments); or (2) that occurs in an area 
where a listed species is present even if there is no effect on a 
listed species; or (3) where EPA makes a no effect determination 
resulting from mitigation measures adopted by EPA. Another commenter 
stated the ESA requires the Service to issue a written concurrence for 
an action agency's not likely to adversely affect determination. A 
commenter also suggested that the decision in NRDC v. Houston, 146 F.3d 
1118 (9th Cir. 1998) means that the ESA prohibits EPA from making NLAA 
determinations without consulting with the Services. Another commenter 
suggested that the counterpart regulations change the threshold for 
consultation from ``may affect'' to ``likely to adversely affect.''
    Response: The Services disagree with these legal conclusions. The 
Services have concluded that the counterpart regulations do not violate 
the language or spirit of the ESA. The ESA does not contain an express 
statutory standard for determining when formal consultation under 
section 7 is required for a proposed agency action. The 1978 
congressional report cited by the commenter in support of a ``may 
affect'' threshold for formal consultation addressed a draft bill that 
was not enacted by Congress. The ESA amendments adopted in 1978 do not 
contain the statutory language discussed in the congressional report. 
In 1986, the Services issued the subpart B regulations requiring formal 
consultation for an action that may affect a listed species or critical 
habitat, but allowing the use of alternative procedures to determine 
that an action is ``not likely to adversely affect'' (NLAA) listed 
species or critical habitat and thereby conclude the consultative 
process.
    As stated in the 1986 regulations, Sec.  402.01, ``Section 7(b) of 
the Act requires the Secretary, after the conclusion of early or formal 
consultation, to issue a written statement setting forth the 
Secretary's opinion detailing how the agency action affects listed 
species or critical habitat.'' However, neither informal consultation 
nor NLAA concurrence is specified in the ESA, and the ESA does not 
prescribe requirements directing how the Services should consult with 
federal agencies on NLAA actions. The Services have exercised their 
discretion through rulemaking to establish an alternate procedure for 
actions that are NLAA. The general informal consultation procedure in 
subpart B, with an individualized concurrence letter from the Services, 
reflects an exercise of the Services' discretion. Federal agencies and 
the Services have effectively employed this alternative to formal 
consultation several hundred thousand times over the past two decades 
for a myriad of diverse agency actions, and use of this alternative has 
been upheld in many court decisions. The counterpart regulations rely 
upon the fundamental structure in the subpart B regulations that 
created an informal consultative process for actions that are not 
likely to adversely affect listed species or designated critical 
habitat, and required formal consultation for other actions to ensure 
that 7(a)(2) requirements are met.
    The counterpart regulations represent an alternative form of 
informal consultation for NLAA actions subject to Sec.  402.45, 
creating a new, carefully-structured training, monitoring and oversight 
relationship between the Services and EPA as an alternative for the 
individual project-based concurrence system that was created in the 
subpart B regulatory framework. The counterpart regulations create a 
system where EPA uses a risk assessment methodology approved by the 
Services, engages in regular exchanges of scientific information with 
the Services, and its staff is trained and supervised to perform NLAA 
determinations just as the Services would in a concurrence letter, with 
less delay and equal protection for listed species and critical 
habitat.
    The Services believe that through implementation of the ACA, and 
the provisions of Sec.  402.45 for periodic review, oversight, and 
termination of the ACA by the Services if necessary, EPA is insuring, 
in consultation with and with the assistance of the Secretary, that 
FIFRA actions are not likely to jeopardize the continued existence of 
any listed species or result in the destruction or adverse modification 
of critical habitat. For these reasons, the Services believe that the 
counterpart regulations comply with the ESA.
    As reflected in the record of this rulemaking, the Services have 
concluded that the approach to ecological risk assessment described in 
EPA's Overview Document is consistent with the ESA, and that this 
approach 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 (See Letter from 
S. Williams and W. Hogarth to S. Hazen, January 26, 2004). Accordingly, 
the Services' opinion, which has taken into account the provisions of 
section 7(b)(3), is that actions for which EPA makes NLAA 
determinations are not likely to jeopardize the continued existence of 
any listed species or result in the destruction or adverse modification 
of critical habitat. Morevoer, the Services have developed and 
discusses drafts of the Alternative Consultation Agreement with EPS. 
The Services and EPA believe that the draft ACA released to the public 
with the proposed counterpart regulations would, with little 
substantive alteration, form the basis for a future final ACA. The 
Services' confidence in the conclusions about the adequacy of EPA's 
future NLAA determinations is strengthened by the agencies consensus on 
the need for (and content of) detailed provisions in the ACA that will 
guide the implementation of Sec.  402.45. Therefore, this alternative 
form of informal consultation does not require separate written 
concurrence for individual FIFRA actions. Interagency coordination will 
continue to occur on NLAA actions through the implementation of the ACA 
and the ongoing review and monitoring

[[Page 47743]]

program. The alternative form of informal consultation described in 
Sec.  402.45 reflects the exercise of the Services' discretion tailored 
to the specific circumstances of FIFRA actions.
    In any case when EPA determines that a FIFRA action may affect a 
listed species or critical habitat, EPA is required to follow either 
the provisions of these counterpart regulations, or the provisions of 
the existing subpart B regulations. Further, the counterpart 
regulations continue to require formal consultation, in the manner 
provided in the regulations, for FIFRA actions that are likely to 
adversely affect a listed species or critical habitat. Therefore, the 
counterpart regulations do not change the threshold for consultation, 
as one commenter believes.
    The Services note that the court decision cited by a commenter 
involved consultation under subpart B where a concurrence letter from 
the Service is required to conclude informal consultation; the case 
does not interpret the ESA as creating a statutory duty for an action 
agency to obtain a concurrence letter from the Service on NLAA actions.
    Finally, the Services note that under subpart B, neither informal 
nor formal consultation is required if a proposed agency action will 
have no effect on a listed species that is present within the action 
area, whether or not the ``no effect'' finding results from mitigation 
measures adopted by the action agency. Under subpart B, the Services do 
not review an action agency's finding that a proposed action will have 
no effect on listed species or critical habitat. The counterpart 
regulations carry forward the same provisions for ``no effect'' actions 
and are consistent with the requirements of section 7 of the ESA and 
the subpart B regulations.
    Comment: Several commenters questioned the legal validity of Sec.  
402.46 and associated provisions on the ground that the section 
improperly delegates or transfers to EPA the Services' duty to prepare 
a biological opinion at the conclusion of formal consultation, or 
limits the Services' ability to reject an effects determination 
prepared by EPA for use as a biological opinion. Conversely, another 
commenter suggested that EPA should have the full responsibility for 
the adequacy of its effects determinations, and there should never be 
any reviewable agency action by the Services in a formal consultation 
on a FIFRA action, or at least the Services should have to meet a 
specified burden of proof to reject an EPA effects determination in a 
formal consultation.
    Response: The counterpart regulations do not delegate or transfer 
to EPA or otherwise limit the Services' ability to fully perform any 
legal duty assigned by law to the Services. Section 7 of the ESA 
requires that formal consultation must conclude with an opinion issued 
by the Services based on the best scientific and commercial data 
available. The Services have retained full legal authority to perform 
this duty. The ESA does not prohibit an action agency from contributing 
to the biological analysis performed during consultation. The Services 
are taking advantage of EPA's expertise in ecological risk assessment 
by allowing EPA to prepare an effects determination that can serve as a 
biological opinion if approved by the Services. If in the judgment of 
the Service an effects determination does not contain the information 
required in a biological opinion, the Service will not consider it for 
use under Sec. Sec.  402.46 or 402.47. The Services retain full and 
complete discretion to accept, modify or reject EPA's effects 
determinations, and the Services remain fully responsible for every 
biological opinion issued at the conclusion of formal consultation. 
While the Services expect EPA's effects determinations to be accurate, 
there is no requirement that the Services must automatically accept any 
effects determination, even if there is ``substantial evidence'' (a 
legal term of art) to support it; the Services must determine the 
adequacy and accuracy of every effects determination. The Services do 
not have to meet any specified burden of proof to issue a biological 
opinion disagreeing with an EPA effects determination. The Services 
believe requiring them to meet a specified burden of proof to reject an 
EPA determination is not consistent with their statutory 
responsibilities and therefore reject that approach. For clarification, 
the Services wish to note that the counterpart regulations as adopted 
do not completely follow an earlier approach suggested in the ANPR 
regarding automatic presumption of validity for EPA findings. For these 
reasons, under Sec. Sec.  402.46 and 402.47, the Services' biological 
opinions constitute agency action by the Services as required by the 
ESA, although the Services agree that EPA has full responsibility for 
the adequacy of the effects determinations it prepares for FIFRA 
actions.
    Comment: The provisions for partial consultation violate the ESA 
because a comprehensive biological opinion must be completed before 
initiation of the agency action, and this procedural requirement has 
substantive implications. Moreover, the provision allows EPA to use 
partial reviews to validate any subsequent determination that an 
allowed use does not violate the 7(d) restrictions.
    Response: As noted previously, 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 does not reduce EPA's 
consultation duties compared to subpart B. Rather, for certain complex 
FIFRA actions the provision strengthens 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 will 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 
will not represent the opinion of the Secretary or operate as an 
incidental take statement under section 7(b) of the ESA until all 
required consultation is concluded on listed species and critical 
habitats. With regard to the possibility that EPA may use such partial 
biological opinions to validate a subsequent determination to proceed 
with an action, the Services note that, like any action agency, EPA 
retains statutory authority to use appropriate information to make 
section 7(d) determinations under the ESA.
    Comment: The provision for successive effects determination 
provisions in Sec.  402.47 violates section 7(d) of the ESA and is 
inconsistent with the central purpose of the ESA to preserve ecosystems 
upon which listed species depend.
    Response: The Services disagree with this comment. The provisions 
of Sec.  402.47 are carefully tailored to fulfill the purposes of the 
ESA and to comply with section 7(d), which allows the action agency, 
and not the Services, to determine whether an action can proceed before 
consultation is concluded.
    Comment: The counterpart regulations should be expanded to address 
actions that would be exempt from any consultation. Not every FIFRA 
action will require an effects determination; the list of categorical 
exclusions should be incorporated as part of the ACA or the counterpart 
regulations.
    Response: The Services have not accepted these suggestions. The 
action agency (here EPA) determines the agency actions on which it 
wishes to

[[Page 47744]]

consult and can make a no effect finding for an action without review 
by the Services. The ESA does not contain an express provision for 
categorical exclusions, a term employed under the National 
Environmental Policy Act. However, action agencies have the opportunity 
to conduct programmatic or other broad-scale reviews to identify 
individual actions that do not require any consultation.
    Comment: The proposed counterpart regulations improperly transfer 
the primary duty to avoid jeopardy to listed species from the Services 
to EPA.
    Response: The Services disagree with this comment. Under the ESA, 
action agencies have the independent legal duty to avoid activities 
that are likely to jeopardize listed species. The Services assist 
action agencies in meeting this duty through consultation, and will 
continue to do so under the new consultation procedures provided in 
these counterpart regulations.
    Comment: The counterpart regulations will lessen EPA's duty or 
ability to avoid actions that are likely to jeopardize the continued 
existence of a listed species.
    Response: The Services disagree with this comment. EPA's duty and 
ability to avoid jeopardy are unchanged. In fact, the Services believe 
EPA may be able to do a better job of avoiding jeopardy under the 
counterpart regulations because consultations can be completed faster 
and in greater numbers than may be possible under subpart B procedures.
    Comment: EPA has failed to consult with the Services and failed to 
reinitiate consultation when required. Moreover, EPA has not responded 
appropriately to notification from the Services that certain pesticides 
may harm listed species. EPA has never integrated ESA compliance into 
its reregistration process and decisions. EPA has not fully implemented 
recommendations in past Biological Opinions, and has no program for 
protecting species from pesticides.
    Response: While the Services are aware of these criticisms of EPA's 
past record of ESA compliance, the Services intend for these 
counterpart regulations to enable EPA to comply with the ESA more 
effectively in the future. These counterpart regulations do not alter 
EPA's substantive obligations under the ESA in the past or the future. 
The counterpart regulations recognize EPA's expertise in ecological 
risk assessment and are carefully tailored to take advantage of that 
expertise while providing training and meaningful oversight to ensure 
that EPA makes appropriate determinations. Further, the Services have 
reviewed EPA's ecological risk assessment process and concluded that it 
will appropriately integrate consideration of the effects on listed 
species and critical habitat into its regulatory processes under FIFRA.
    Comment: EPA cannot be objective under FIFRA due to conflicting 
statutory mandates, scientific standards, and safeguards for listed 
species. Additionally, EPA lacks the legal authority under FIFRA to 
perform endangered species assessments and anyway, FIFRA legal 
standards of review are different than those of the ESA. Further, EPA's 
ties to industry are too close. EPA has displayed little independence, 
making it incapable of independent assessments.
    Response: The Services disagree with this comment. The Services 
believe EPA is objective in its application of the risk assessment 
methodologies that have been endorsed by the Services. The Services 
have a variety of tools available to assure that EPA's effects 
determinations are objective and scientific and intend to use these 
tools to achieve that goal as necessary. The Services do not opine on 
the scope of legal authority of an action agency under the statutes it 
implements such as FIFRA or other separate legal requirements. EPA must 
also comply with the ESA, and the Services do not believe there is 
inherent conflict between the ESA and FIFRA that would prevent EPA from 
being able to do so.
    Comment: It is imperative to develop an organized and 
scientifically defensible prioritization of previously registered 
products not yet consulted on. Further, EPA should give highest 
priority to currently registered pesticides for which EPA is actively 
preparing Reregistration Eligibility Decisions under FIFRA section 4 
and to pesticides seeking new registration under FIFRA section 3. A 
number of these contain new active ingredients which would pose less 
environmental and public risks than the pesticide products they would 
replace, e.g., products to replace the acutely toxic organophosphate 
insecticides or the fumigant, methyl bromide. A related comment stated 
that the rule and the ACA should either recognize EPA's existing 
priority-setting process for decisions concerning new registrations, or 
allow the agencies to develop a similar process.
    Response: These comments are beyond the scope of the proposed 
rulemaking for the counterpart regulations. However, the Services note 
that the Services and EPA are discussing prioritization, although 
action agencies determine when to bring their actions to the Services.
    Comment: EPA should be designated the lead regulatory agency in 
making pesticide product risk assessment and risk management 
determinations as they relate to the potential impact on endangered 
species or habitat.
    Response: The Services agree that, within the confines of the ESA, 
EPA has initial responsibility for assessing impacts of pesticides to 
threatened and endangered species. The intent of the counterpart 
regulations is for the Services to take greater advantage of EPA's 
expertise in ecological risk assessment while continuing to exercise 
all duties required by the ESA.
    Comment: Since FIFRA already provides a procedure for public input 
and comment, it would be duplicative to publish a Federal Register 
notice allowing input by the public in the alternative consultation 
process.
    Response: The commenter has misconstrued the regulation. This 
regulation does not require such a notice to be published in the 
Federal Register.
    Comment: The counterpart regulations should ensure that interagency 
exchanges and public disclosure of proprietary data and applicant-
prepared summaries of data are consistent with section 10 of FIFRA and 
with EPA's information regulations at 40 CFR 2.209(c) regarding the 
treatment of confidential business information.
    Response: The counerpart regulations do not alter in any respect 
the Government's obligations under either section 10 of FIFRA or EPA's 
information regulations regarding the protection of information that 
either may be, or has been determined to be, confidential business 
information. EPA regulations at 40 CFR part 2 address in detail the 
conditions under which such information may be shared by EPA with other 
government agencies, how such agencies must protect the information, 
and the circumstances under which such information is subject to public 
disclosure. Accordingly, the Services do not believe it necessary to 
revise the proposed rule to address this matter.
    Comment: EPA should perform the risk assessment in the course of 
pesticide registration, in accordance with Service procedures. Should 
disagreement on the NLAA determination occur, the Services should have 
to carry the burden to overturn the determination and show that the EPA 
analysis was incorrect.
    Response: The commenter has misconstrued the applicable procedures 
regarding NLAA determinations. Under these counterpart regulations EPA 
may make NLAA determinations without

[[Page 47745]]

obtaining written concurrence from the Services. The Services will 
conduct a review of EPA's program for making NLAA determinations in the 
course of their monitoring and oversight activities, for the purpose of 
determining whether EPA's program is based on the best scientific and 
commercial information available and is consistent with ESA and 
applicable implementing regulations.
    Comment: If EPA and the Services are to agree on a risk assessment 
process that accomplishes both the goals of FIFRA registration and ESA 
section 7 consultation, then EPA should be able to employ the risk 
assessment process for both purposes with minimum oversight by the 
Services.
    Response: The Services interpret this comment as an expression of 
support for the counterpart regulations and believe that, to the extent 
that the comment urges less oversight, the process and degree of 
oversight provided under the rule is appropriate.
    Comment: Agencies should develop and adopt a specific plan for 
transitioning currently on-going consultations to the final counterpart 
regulations.
    Response: Although the development of a plan is not required by the 
regulations, the Services recognize the appropriateness of coordinating 
with EPA to implement these counterpart regulations for any 
consultations not yet completed when these regulations take effect.
    Comment: The Consultation Handbook should be replaced or rewritten 
to specifically apply to the counterpart regulations and the ACA.
    Response: The Services will review the Consultation Handbook in 
order to ensure that it is consistent with the regulations.
    Comment: The counterpart regulations do not provide enough time for 
thorough consultation.
    Response: The counterpart regulations are consistent with the 
statutory timelines for consultation in section 7.
    Comment: The proposed regulations do not adequately provide 
remedies for stakeholders in the event that action deadlines are not 
met during the consultation process.
    Response: The Services are committed to meeting all deadlines 
imposed by the counterpart regulations and decline to provide 
additional enforcement remedies. However, the Services believe the new 
procedures will increase the timeliness of the consultation process.
    Comment: Clarification is needed in the counterpart regulations as 
to how the ESA consultation process will affect EPA's ability to meet 
deadlines for pesticide registration and reregistration in FIFRA as 
established by the Pesticide Registration Improvement Act (PRIA) of 
2003 and the Food Quality Protection Act (FQPA) of 1996.
    Response: EPA has an obligation to comply with section 7(a)(2) in 
connection with certain pesticide regulatory actions it takes under 
FIFRA. The counterpart regulations do not alter that obligation nor do 
they alter any of EPA's obligations under FIFRA. The rule is intended, 
rather, to improve the effectiveness and efficiency of the consultation 
process. In turn, this should help ensure that EPA can, in a timely 
manner, make pesticide regulatory decisions for which ESA consultation 
is required. The counterpart regulations should, therefore, assist EPA 
in its efforts to meet the deadlines provided in PRIA and the FQPA.
    Comment: Decisions on pesticide uses that have no effect or are not 
likely to adversely affect listed species should not be delayed until 
decisions have been made on uses that require formal consultation.
    Response: Under both the existing regulations and the counterpart 
regulations, EPA retains the authority to identify the scope of its 
action, consistent with the definition of ``action'' in Sec.  402.02. 
Consequently, EPA has the discretion to proceed to make decisions on 
certain uses determined to have no effect or to be NLAA once these 
determinations are made.
    Comment: EPA's Office of Pesticide Programs (OPP) should work more 
closely with that agency's Office of Water.
    Response: The Services are not in a position to direct the internal 
operations of EPA's offices.
    Comment: The proposal should be expanded to include all appropriate 
federal agencies and activities, including, at a minimum, the U.S. Army 
Corps of Engineers and EPA's Offices of Wastewater Management and 
Wetlands, Oceans, and Watersheds. There is no need to place artificial 
limits on what activities may be eligible. The joint counterpart 
regulations should be expanded to include any federal agency that 
retains or develops in-house expertise on endangered or threatened 
species.
    Response: The purpose of these counterpart regulations is for 
consultation under section 7 of the ESA for regulatory actions under 
FIFRA. It is beyond the scope of the counterpart regulations as 
proposed to include agency actions other than EPA regulatory actions 
under FIFRA.
    Comment: The proposed ``no concurrence'' approach to NLAAs sets a 
bad precedent for other agencies and should therefore be avoided.
    Response: These counterpart regulations are tailored to EPA's 
existing expertise and knowledge of pesticides regulated under FIFRA. 
If the Services adopt future counterpart regulations for other federal 
agencies, those rules would be based on each agency's capabilities and 
experience.
    Comment: Separate consultation rules for FIFRA actions are 
warranted because such actions are fundamentally different from other 
federal agency actions subject to ESA section 7.
    Response: The Services agree that counterpart regulations for FIFRA 
actions are warranted. Other federal agencies also consult on large and 
complex actions, and whether counterpart regulations would be 
appropriate for other agencies would be considered by the Services on a 
case-by-case basis.
    Comment: It is troubling that EPA is not a cosponsor of these 
regulations. The final counterpart regulations should include an 
amendment to Sec.  402.04 so that its first sentence reads as follows 
(new language italicized): ``The consultation procedures set forth * * 
* the National Marine Fisheries Service, or by regulations promulgated 
by the Services alone in the event the action agency has concurred in 
that procedure.'' The Services should also include a letter from the 
Administrator of EPA (or other appropriate Agency official) expressing 
the Agency's concurrence in the record of this proceeding.
    Response: The proposal did not extend to subpart B, and the 
Services therefore decline to amend Sec.  402.04 in this final rule. 
The Services note that EPA supported the development of the counterpart 
regulations and the Services do not believe the suggestions are legally 
necessary.
    Comment: USDA should have the lead for developing processes that 
support an approach to determining pesticide exposure mitigation 
methods. Also, USDA should be included in some official capacity during 
consultation, to ensure knowledge of actual land management practices.
    Response: EPA is the lead action agency; however, the Services have 
been assured that EPA will continue to collaborate with USDA as well as 
the Services in developing appropriate and necessary mitigation 
measures, and obtaining knowledge of land management practices.
    Comment: EPA and the Services must coordinate with other offices 
and

[[Page 47746]]

agencies beyond USDA, as appropriate, when dealing with antimicrobials.
    Response: The Services will endeavor to coordinate with other 
offices as appropriate.

EPA's Ecological Risk Assessment Process

    A series of general comments stated the Services should not adopt 
the proposed rule because it is based on EPA's flawed approach to 
ecological risk assessment and EPA lacks expertise in key areas of 
ecological risk assessment.
    Comment: It is necessary for the sake of consistency to include, 
either in the counterpart regulations or in the Overview Document, 
clearly described work flows of the screening-level risk assessment 
process.
    Response: The Services disagree that the counterpart regulations 
must describe the details of the screening-level risk assessment 
process. The Services do not believe that a description of the workflow 
within the Overview Document is necessary to analyze the adequacy of 
the ecological risk assessment process.
    Comment: EPA's approach generally is not adequate for identifying 
and quantifying the effects of pesticides, because it is not rigorous 
and not consistent with the current state of scientific knowledge. 
Because of these shortcomings, EPA will probably mistakenly determine 
that a pesticide either had no effect or was not likely to adversely 
affect listed species.
    Response: The Services disagree that EPA does not have an adequate 
ecological risk assessment methodology. After an extensive and 
intensive review of EPA's approach to assessing the risks of pesticides 
to listed species and critical habitat, the Services concluded that 
EPA's approach ``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.'' See Letter from Steve Williams, Director, FWS, and 
William Hogarth, Assistant Administrator, NMFS, to Susan B. Hazen, 
Principal Deputy Assistant Administrator, EPA, dated January 26, 2004 
(Letter of January 26, 2004).
    More specifically, in the Services' expert judgment, the approach 
used by EPA is rigorous; it is carefully described in the ``Overview of 
the Ecological Risk Assessment Process in the Office of Pesticide 
Programs, U.S. Environmental Protection Agency--Endangered and 
Threatened Species Effects Determinations'' January 23, 2004 (Overview 
Document) and the 81 support documents cited therein. In addition, 
EPA's risk assessments for individual chemicals are thoroughly 
documented, with the result that it is possible to identify the 
methodology used in each case.
    The Services have also concluded that ``the approach used by OPP 
should produce effects determinations * * * that are consistent with 
those that otherwise would be made by the Services.'' Letter of January 
26, 2004. This conclusion rests on the breadth of types of data that 
EPA will review and the manner in which EPA will analyze the data. EPA 
routinely requires a pesticide company to submit a substantial body of 
data in support of an application for registration. EPA will supplement 
this required database with information obtained through a systematic 
search of the open literature on the ecotoxicity of environmental 
substances. As recounted in detail in the Letter of January 26, 2004, 
EPA will examine this body of information for all of the types of 
potential impacts that an agency is required to consider under the ESA. 
Reliance on these sources of information is consistent with and should 
fulfill the statutory mandate to ``use the best scientific and 
commercial information available.''
    The Services also disagree that EPA's approach to ecological risk 
assessment is inconsistent with current science. EPA's pesticide 
program routinely draws on the latest results from its Office of 
Research & Development (ORD) and other researchers in the fields of 
ecotoxicology and environmental fate assessment through participation 
in national and international professional, scientific conferences and 
symposia. EPA also works closely with the FIFRA Scientific Advisory 
Panel (SAP) to obtain expert, independent, external scientific peer 
review on every aspect of its approach to ecological risk assessment, 
as well as on specific pesticide assessments. See http://www.epa.gov/scipoly/sap/ As a consequence of this active exchange of ideas and 
expertise with scientific leaders, EPA regularly makes changes to 
improve its methodologies to reflect current science.
    Comment: Claims that EPA's risk assessment process is sufficient 
given the role played by the SAP are misplaced. As demonstrated in 
recent actions involving atrazine, EPA has demonstrated a willingness 
to ignore SAP conclusions.
    Response: The Services appreciate the value that may be gained by 
EPA's use of the SAP as an independent peer review. However, the 
Services' conclusion about the adequacy of EPA's approach to ecological 
risk assessments is based on our independent review of the approach 
identified in the Overview Document, of which SAP review is only one 
part. Ultimately, this conclusion does not rely upon how EPA may have 
responded to any particular recommendation from the SAP.
    Comment: An independent scientific panel with no ties to industry 
should be convened to review all pesticide registrations and only peer-
reviewed data should be used in determinations.
    Response: The Services note that although the ESA does not require 
the use of an outside scientific review panel, it is at EPA's 
discretion to do so during pesticide registration if it so chooses. The 
Services also note that limiting information considered to only peer 
reviewed data is contrary to the statutory requirement of the ESA which 
requires the use of the ``best scientific and commercial data 
available.''
    Comment: EPA's approach to ecological risk assessment is deficient 
because it fails to identify up front, even generally, which listed 
species could potentially be affected by a particular pesticide, and 
thereby limits the effectiveness of its review by failing to account 
for species-specific and habitat-specific information in its 
assumptions, tests, and models. An additional comment suggested the 
need for more involvement at the field and regional level to capture 
such information.
    Response: Based on the Services' review of the Overview Document, 
during its initial screen EPA will assess possible toxic effects on all 
species, including listed species, using the best scientific and 
commercial data available for this purpose. If EPA determines that any 
listed or non-listed species may be harmed by a pesticide, EPA will 
obtain and consider the best available information concerning species-
specific and habitat-specific information to determine the extent of 
those effects on listed species. EPA will do so with the assistance of 
appropriate field and regional involvement of the Services. The 
Services believe this is a sound approach to analyze all potential 
risks to listed species, and disagree that this limits the 
effectiveness of EPA's review.
    Comment: EPA fails to apply the precautionary principle to its 
regulation of pesticides. EPA assumes no risk to listed species when 
EPA lacks data. EPA should begin its assessment with the assumption the 
pesticide will harm listed species and require evidence to the contrary 
before allowing the chemical's use. Whenever EPA has a data gap, it 
should require registrants to provide the information necessary to fill 
that gap.

[[Page 47747]]

    Response: The Services believe that EPA's ecological risk 
assessment approach is appropriately cautious in assessing the effects 
of pesticides to listed species. EPA will use the best scientific and 
commercial information available to assess risks and will consider all 
potential risks in light of that information.
    More specifically, the assertion that EPA assumes no risk to listed 
species when EPA lacks data misconstrues EPA's approach in the absence 
of data. As explained in the Overview Document, EPA has identified a 
base set of information about a pesticide it considers sufficient to 
permit an evaluation of the potential risks posed by the pesticide, and 
has committed to supplement those data with information obtained from 
the public literature. The types of data required will vary depending 
on the use pattern of the product and chemical-specific characteristics 
of the pesticide. EPA requires these data to support the registration 
of a pesticide, and, unless the data are waived, EPA typically would 
not approve the use of a pesticide without the required data. If data 
beyond the base set are considered necessary, EPA will require the 
applicant to provide those data. The agency will use its best 
scientific judgments, on a case-by-case basis, and as discussed in 
detail in the Overview Document, EPA may employ assumptions to account 
for any uncertainty due to missing data, and many steps within EPA's 
approach use conservative assumptions.
    The ESA does not require Federal agencies to eliminate all forms of 
uncertainty in assessing impacts to listed species or critical habitat, 
which would be a practical impossibility. Instead, the ESA requires 
that decisions be based on the best scientific and commercial data 
available. The Services agree that such decisions need to be made on a 
case-by-case basis, using best professional judgment that takes into 
account all of the available relevant information. The Services have 
discussed with EPA the need to document in a transparent manner how it 
addresses data gaps and how it employs assumptions to deal with the 
resulting uncertainty. The Services are satisfied that EPA's approach 
to this general subject, as described in the Overview Document, will 
result in appropriate assessments of the potential risks to listed 
species and critical habitat.
    Comment: EPA's approach to ecological risk assessment is flawed 
because EPA relies on information supplied by registrants which is 
therefore biased, and also because EPA does not use the peer-reviewed 
public literature appropriately. EPA does not have a standard process 
for locating and obtaining data from the open literature and therefore 
fails to locate a significant percentage of the available literature. 
The commenter noted two instances in which EPA had failed either to 
locate or to use a published study that, the commenter believed, was 
relevant to the risk assessment for a pesticide.
    Response: The Services devoted a considerable amount of attention 
to the manner in which EPA obtains information on which it bases its 
effects determination, including data from the open literature 
(including from both peer-reviewed and non-peer-reviewed sources). EPA 
is required to base its determinations on the best scientific and 
commercial data available. Therefore, to the extent that the 
information supplied by the registrant may be the best scientific and 
commercial data available, EPA is required to consider the information. 
As part of the discussions, EPA has committed to conducting literature 
searches using ECOTOX as part of its ecological risk assessments for 
pesticides. The ECOTOX database is a comprehensive system, maintained 
by EPA's ORD, that provides information on chemical effects on 
ecological species. The publicly available component of ECOTOX is 
widely used by other Federal, State, tribal and local government 
agencies (including the Services), international governmental agencies, 
the regulated community, the wider scientific research community and 
the public. As discussed in the Overview Document and the Letter of 
January 26, 2004, EPA's literature search will capture both studies in 
the publicly available component of ECOTOX and other studies that 
either have not yet been completely processed and entered into ECOTOX 
or were considered and rejected as inappropriate for inclusion in the 
public, web-based component.
    Experience to date comparing the results of these broader ECOTOX 
searches conducted according to the Overview Document with other search 
strategies suggests that ECOTOX is at least as successful, if not more 
so, at locating relevant scientific information. Moreover, contrary to 
the comment, these comparisons indicate that ECOTOX does not fail to 
identify a significant portion of the relevant literature.
    Finally, the Services do not find persuasive the comment stating 
that EPA did not consider a relevant study from the public literature. 
Whether or not that is accurate, it does not undermine the Services' 
conclusion, in the future, that EPA will use an acceptable approach to 
assessing ecological risks of pesticides. The Services note that EPA 
has committed to explaining in its risk assessments any decisions not 
to use a study obtained from the open literature or other source. Thus, 
if EPA obtains a study published in a scientific journal but decides 
not to make it part of the risk assessment database, the decision will 
be fully documented, and both the Services and the public would be able 
to evaluate the adequacy of EPA's justification. The Services believe 
this process will ensure that EPA handles studies from the open 
literature appropriately.
    Comment: EPA excludes information generated using methodologies 
that do not conform exactly to the EPA's overly strict ``Good 
Laboratory Practices'' (GLP) guidelines.
    Response: The comment mischaracterizes EPA's approach to the use of 
data from the public literature. As stated in the Overview Document, 
data from the open literature can be used in developing the risk 
assessment. Since such information is typically not collected using the 
EPA's GLP guidelines, it is normally considered ``supplemental 
information,'' meaning that a registrant usually could not satisfy its 
responsibilities to fulfill EPA's data requirements using such data, 
but that EPA could and would still use such data as appropriate in the 
risk assessment.
    Comment: EPA relies inappropriately on ``surrogate species'' in its 
risk assessment. EPA typically has insufficient information about risks 
because the agency usually lacks testing using important classes of 
animals--namely amphibians, reptiles, marine mammals, and freshwater 
mussels--and, despite this limitation, EPA does not include any 
uncertainty factor to account for the possible variation in sensitivity 
across species which can be three orders of magnitude.
    Response: The Services carefully examined EPA's use of toxicity 
data from tests with surrogate species. EPA's Overview Document 
identifies the approximately two dozen different animal and plant 
species that an applicant or registrant (commonly a pesticide company) 
is required to study in the standard battery of eco-toxicity tests on a 
pesticide. The commenters are correct that such species do not include 
any amphibian, reptilian, or fresh water mussel species. As discussed 
above, EPA will review the open literature, and it is possible that 
studies from that source may contain information on the toxicity of a 
pesticide to additional

[[Page 47748]]

species. EPA will use its best scientific judgment to choose the most 
appropriate surrogate for a listed species from all of the available 
data. Even with this extensive database, however, risk assessments 
necessarily must be based on testing with a finite number of species. 
When a species has not been tested, the data on surrogate species 
constitutes the best available scientific and commercial information to 
analyze the toxicological sensitivity of untested species.
    Further, EPA has agreed to discuss in its risk assessments the 
uncertainties associated with use of surrogate species. EPA also 
committed to work with the Services to develop methods to increase the 
level of confidence in future assessments.
    Finally, although not employed expressly to address uncertainties 
in relying on surrogate species, the Services note that throughout its 
risk assessment methodology EPA deliberately uses conservative 
assumptions that add in a measure of additional protections.
    Comment: EPA's approach to ecological risk assessment ignores the 
potential for pesticides to cause adverse, non-fatal, ``sublethal'' 
effects on non-target plants and wildlife. In particular, the studies 
required by EPA are incapable of measuring effects on reproductive 
systems, immune systems, endocrine systems, and genetic integrity. In 
addition, one commenter argued that EPA would not consider data showing 
atrazine caused adverse effects on the sexual development of frogs.
    Response: The Services disagree; as explained in EPA's Overview 
Document, the set of eco-toxicity studies required to support the 
registration of a pesticide include numerous sublethal endpoints, 
including the impact of the test substance on reproductive function, as 
well as endpoints related to body weight, body length, gross 
pathological effects, and behavioral abnormalities. In addition, EPA 
has committed to augment its required studies with any information 
obtained from the open literature, and to use such data on sublethal 
effects to the extent that sufficient and reliable information 
establishes a scientifically sound relationship between the effect and 
the survival or reproductive capacity of an organism. The Services have 
deemed appropriate the existing sublethal endpoints that are included 
by OPP in its risk assessment process, and the manner in which they are 
used for purposes of assessing potential sublethal effects.
    In response to the comment concerning EPA's willingness to consider 
sublethal effects from atrazine, the Services note that, contrary to 
the comment, EPA has conducted its own review and subsequently has 
obtained an independent, external peer review of data on atrazine and 
sexual development of frogs. See SAP meeting on June 17-20, 2003, at 
http://www.epa.gov/oscpmont/sap/2003/index.htm. This series of reviews 
has led EPA to require the registrants of atrazine to perform 
additional studies to evaluate these possible effects.
    Comment: EPA does not perform a substantial analysis of indirect 
effects of a pesticide on listed species. EPA had not documented its 
conclusion that exposure to pesticide concentrations less than \1/2\ 
the LC50 would not cause effects on non-listed species that could 
indirectly affect a listed species dependent on that non-listed 
species. Moreover, EPA incorrectly assumes that where a pesticide has 
no direct effects on listed species, there is no potential for indirect 
effects.
    Response: Although EPA may not have routinely and fully examined 
the potential indirect effects of a pesticide on listed species and 
critical habitat in the past, EPA has committed in its Overview 
Document to the systematic consideration of such indirect effects. The 
Services will, on request, provide EPA with information on listed 
species that will assist EPA in identifying the relevant biological and 
ecological relationships through which indirect effects might occur.
    The commenter also misunderstands the approach to assessing 
indirect effects. The commenter apparently assumes that the direct-
effects screening assessment considers only listed species. A 
conclusion that no indirect effects on a listed species would occur is 
based on the fact that indirect effects may only occur when some 
species--listed or nonlisted--other than the listed species is directly 
affected. The direct-effects screening assessment considers the full 
range of plant and animal species. If no species on which a listed 
species depends is directly affected, then the listed species would not 
be indirectly affected.
    Contrary to the comment, EPA has explained in the Overview Document 
its approach to the use of different thresholds for listed and non-
listed species. The Services are satisfied that the approach EPA 
intends to use in the future will produce an appropriate assessment of 
potential indirect effects.
    Comment: EPA's approach to assessing impacts to critical habitat is 
inappropriate, because it assumes that if a pesticide will not have a 
direct effect on the listed species, then it will not affect the 
habitat. Moreover, this approach is faulty because it only considers 
the biological elements of the habitat, and does not take into account 
the negative impacts of pesticide contamination that would make an area 
unsuitable.
    Response: The commenter misunderstands the approach to assessing 
risks to critical habitat. EPA uses the same approach to assessing the 
effects of a pesticide on critical habitat as it uses to assess direct 
effects on listed species. The difference, however, is that EPA looks 
at the effects on the principle constituent elements of the critical 
habitat--those elements of the habitat on which a listed species 
depends--rather than on the listed species itself. The Services 
disagree that a pesticide will have negative impacts without affecting 
any biological element of the habitat. Pesticides do not automatically 
have an effect simply as a consequence of their presence; rather, the 
presence of a pesticide in a portion of the habitat constitutes harm to 
habitat only to the extent it may negatively affect some biological 
component of that habitat, which is what EPA assesses.
    Comment: Cumulative stressors and impacts to endangered and 
threatened species will no longer be fully addressed.
    Response: The ecological risk assessment process as described in 
the Overview Document commits EPA to consider the environmental 
baseline when appropriate. As part of the environmental baseline, 
cumulative stressors and impacts to listed species will be considered.
    Comment: EPA does not evaluate the potential effects of exposure 
either to inert ingredients in pesticide formulations or to substances 
formed by the environmental degradation of pesticides.
    Response: The comments are incorrect. EPA's Overview Document 
describes the extensive information required to characterize the 
environmental fate of a pesticide, including the identification of any 
toxicologically significant degradation products/metabolites. In 
addition, absent information supporting a different conclusion, EPA 
assumes that any substance formed by the breakdown of a pesticide is as 
toxic as its parent compound. Although limited, EPA also receives 
information from pesticide applicants and registrants about individual 
inert ingredients in pesticide formulations. The ECOTOX literature 
search also captures information on mixtures containing pesticide 
active

[[Page 47749]]

ingredients. EPA has committed to review these data as part of its 
ecological risk assessments. Finally, the Overview Document spells out 
how EPA will use the data it obtains on the toxicity of pesticide 
formulations.
    The Services recognize that more extensive information is typically 
available about pesticide active ingredients than inert ingredients, 
and therefore EPA has a more limited ability to assess the risks posed 
by these compounds to listed species. In light of these limitations, 
the Services have concluded that EPA's approach makes appropriate use 
of the best scientific and commercial information available to evaluate 
these types of substances.
    Comment: Active ingredients are typically formulated with other, 
sometimes more toxic ``inert'' substances to make pesticide products 
and such products are then often mixed with adjuvants. EPA's risk 
assessment process fails to consider the effects of pesticide mixtures 
on endangered and threatened species. EPA does not assess the potential 
additive or synergistic effects of exposure to the combination of these 
substances. Such combinations are important because water monitoring 
data demonstrate the presence of multiple chemicals in many water 
samples and that many of the substances appearing in combination share 
a common mechanism of toxicity.
    Response: While there often is very little or no information, EPA 
has committed to review the open literature for information on whether 
a pesticide formulation or other chemical mixture will be active in an 
additive, synergistic or antagonistic manner. If EPA identifies data 
demonstrating interactive effects, it will use the data in its 
ecological risk assessments to the extent possible. The Services 
believe this approach is scientifically appropriate and consistent with 
the ESA. The Services recognize, however, that this approach still 
leaves some scientific uncertainty about whether pesticides and other 
chemicals will interact to produce more serious effects than expected 
from exposure to individual compounds. There is no scientific consensus 
on how to address this source of uncertainty. Therefore the Services 
also think it is appropriate that EPA has committed to the 
identification of major sources of uncertainty in its risk assessments.
    Comment: EPA does not appropriately consider cumulative effects as 
required under the ESA. Under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), EPA is required to assess cumulative effects for food use 
pesticides and other substances sharing a common mechanism of toxicity.
    Response: EPA's Overview Document contains a commitment to conduct 
a review of cumulative effects, as defined under the ESA, on those 
FIFRA actions for which EPA cannot conclude that the action is not 
likely to adversely affect listed species or critical habitat. Since 
the nature of any cumulative assessment will depend on the scope of the 
action being considered, the Services think that EPA has appropriately 
expressed an intention to evaluate such effects on a case-by-case 
basis. The Services and EPA intend to work together to ensure that an 
adequate evaluation of the cumulative effects is performed for an 
action.
    The Services note that the meaning of the term, ``cumulative 
effects,'' under the ESA is very different from the way that term is 
used under the FFDCA. Under ESA, cumulative effects refers to the 
effects on listed species and critical habitat of future State and 
private activities reasonably certain to occur within the action area 
of the federal action subject to consultation. Under the FFDCA, EPA 
must consider the cumulative effects on humans that may result from 
exposure to the pesticide chemical and other substances sharing a 
common mechanism of toxicity. Thus, the two meanings are quite 
distinct, and the FFDCA use of the term should not be applied to 
assessments under the ESA.
    Comment: The ``levels of concern'' (LOCs) used as criteria by EPA 
to determine whether potential pesticide exposure would pose a risk to 
a listed species are insufficiently explained and, at least in the case 
of diazinon, insufficiently protective. In particular, EPA has not 
justified its use of the 0.1 and 0.05 LOCs for endangered terrestrial 
and aquatic species, respectively, with acute toxicity values.
    Response: As explained in detail in the Overview Document, EPA 
compares the estimated environmental concentrations expected to result 
from use of a pesticide with toxicity values observed in required 
studies and studies from the open literature. If the resulting ratio is 
less than the LOC, EPA concludes, under the ESA, that the exposure has 
``no effect.'' The agency sets different LOCs for different taxa (birds 
and mammals vs. fish and other organisms), and durations of exposure 
(short term/acute vs. longer term/chronic).
    EPA's Overview Document explains the scientific basis for regarding 
these LOCs as protective. In the case of the LOC of 0.1 for acute 
toxicity, this value means that for a pesticide with a typical toxicity 
profile (slope of the dose-response curve of 4.5) the estimated 
probability of mortality resulting from exposure to one tenth the value 
of the median lethal dose (LC50) is approximately 1/300,000. The 
Overview Document also contains estimates of the probability of 
mortality for the 0.05 LOC and for other values for the slope of the 
dose-response curve. The Services are satisfied both with this 
explanation and with the agency's conclusion that there would be no 
effect when the ratio of exposure to toxicity is at or below the 
established LOCs.
    Comment: EPA does not estimate pesticide concentrations in surface 
water.
    Response: The Services disagree; as EPA's Overview Document and 
other public comments make clear, EPA does develop estimates of 
pesticide concentrations in surface water.
    Comment: The models EPA uses to estimate pesticide levels in water 
are likely to underestimate exposure because EPA uses inappropriately 
low model inputs.
    Response: In the vast majority of cases, the estimates produced 
from EPA's models equal or exceed the amount of pesticide residue 
actually present in surface water. While there may be individual model 
inputs that do not correspond to the highest imaginable value that 
could be used, EPA's information indicates that the particular 
combination of central tendency input values and high end input values 
(many of which are not mentioned by the commenters) produces an 
estimate of the concentration of a pesticide in water that is likely 
substantially greater than occurs under real world conditions in most 
locations where a pesticide is used.
    Comment: The input value for pesticide use is not sufficiently 
conservative because EPA considers only a single pesticide application, 
when in reality multiple applications may be allowed.
    Response: This comment is incorrect; as described in the Overview 
Document, EPA's model assumes the maximum number of applications 
specified on the pesticide label.
    Comment: EPA assumes homogenous distribution of pesticide residues, 
and this will understate residues when there is not complete and 
uniform mixing of residues in the waterbody. In particular, EPA's 
models do not account for pesticide residues that settle on surface 
water films of dust or particulate matter, remain in the water, or 
settle into sediment.
    Response: EPA's model accounts for pesticide residue that drifts 
onto the pond, but it assumes homogenous

[[Page 47750]]

mixing of such residue throughout the water body. As described in the 
Overview Document, there are no scientific models currently capable of 
reflecting variability in short-term concentrations in different parts 
of the pond. Thus, the Services regard EPA's approach to reflect the 
use of the best scientific and commercial information available.
    Comment: Listed species may be present in ponds smaller than the 10 
hectare value used by EPA.
    Response: The comment's description of the pond size used in EPA's 
model is incorrect. As described in the Overview Document, EPA's model 
assumes a very small pond (1 hectare surface area and 2 meters deep), 
receiving runoff from a 10 hectare field.
    Comment: EPA assumes that runoff results from a single runoff 
event, when in reality runoff may occur following multiple runoff 
events.
    Response: This comment is correct with respect to the initial tier 
model used by EPA, GENEEC. The basic GENEEC model calculates potential 
runoff following a single rainfall event, using a conservative 
assumption about total rainfall (6'' in 24 hours). If GENEEC suggests 
water concentrations that could pose concerns, EPA then employs a more 
sophisticated model, PRZM/EXAMS, which considers up to 30 years of 
recorded meteorological data, to place the receiving water body in a 
landscape receiving multiple rainfall events over the duration of the 
meteorological record. It is true that the PRZM/EXAMS model considers 
each rainfall as a single continuous event for each day that the 
available meteorological data has a record for a precipitation event.
    Comment: EPA assumes no contribution from post-application 
volatilization, when in reality such volatilization may contribute 
significantly to residues in the receiving waterbody.
    Response: The Services disagree with this comment. As the Overview 
Document states, losses from volatilization post-application in the 
field are typically taken into account.
    Comment: EPA incorrectly assumes spray drift will contribute no 
more than 1% through ground application and 5% through aerial 
application, when data demonstrate spray drift accounts for higher 
loadings in some circumstances. A related comment stated that EPA's 
existing model estimates drift from aerial applications based on older 
technologies. EPA and the Services should take into account new 
technologies and procedures used by aerial applicators.
    Response: EPA has committed to examining (and changing if 
appropriate) its spray drift assumption as part of the risk 
characterization component of a risk assessment. As described in the 
Overview Document, the values assumed by EPA tend to overstate exposure 
in the vast majority of situations, especially when the water body is 
not immediately adjacent to the treated field, as the model assumes. 
When appropriate data show the model overestimates drift, for example 
because new technologies reduce drift, or underestimates drift, EPA 
will adjust its exposure estimates appropriately.
    Comment: EPA's model does not estimate runoff from urban use, and 
its models do not account for nonagricultural use. Moreover, EPA lacks 
data on the extent of use of pesticides in urban areas and therefore 
cannot develop accurate estimates of environmental exposure from such 
use.
    Response: No adequate models currently exist that are specific to 
estimation of pesticide runoff from urban use, nor that are specific to 
some nonagricultural uses. Moreover, there is rarely accurate and 
complete information on the amounts of pesticides used in urban areas. 
In the absence of such data and models, EPA considers surface water 
monitoring results in the risk assessment process for urban use 
pesticides. If such surface water modeling data, when linked to 
surrounding land use information, suggest that existing modeling 
efforts may underestimate surface water loads in urban landscapes, the 
issue would be discussed in the risk characterization section of a risk 
assessment. This discussion would be accompanied by an analysis of how 
such data affects the agency's confidence in risk assessment 
conclusions. The Services think that this approach is consistent with 
the use of the best scientific and commercial data available to EPA.
    Comment: EPA assessments are based on laboratory data and modeling, 
and EPA often ignores monitoring data or other studies that do not 
accord with its findings.
    Response: The Services disagree. As described in the Overview 
Document, EPA routinely reviews information from monitoring programs 
and compares the results with its model estimates of environmental 
concentrations. Because many factors affect the usefulness of 
monitoring data, EPA decides on a case-by-case basis whether and how to 
use such information. Most commonly, EPA uses such data to help 
characterize the risk assessment by providing information about levels 
in water that reflect different use conditions and different locations 
from those modeled. If the monitoring data show higher confirmed 
detections than estimated by modeling, the higher monitoring values may 
be used in the risk assessment or the input values to the model may be 
reevaluated. EPA has committed to document fully the basis for its 
estimates of aquatic pesticide concentrations. The Services think that 
this approach is consistent with the use of the best scientific and 
commercial data available to EPA.
    Comment: Some of the background documents regarding EPA's risk 
assessment process developed by both EPA and the Services for the 
proposed counterpart regulations are inconsistent with the Information 
Quality Act (IQA) and EPA's IQA guidelines and quality systems--
particularly with regard to EPA's biased use of modeling projections 
over monitoring data. This commenter noted, however, that the proposed 
regulatory provisions are statutorily authorized, rational and should 
be promulgated as soon as possible.
    Response: The Services agree, as this commenter noted, that the 
issues raised regarding the IQA do not suggest the need for 
modification to the provisions of the proposed rule. This commenter did 
not suggest that the IQA issues raised reflect upon EPA's ability to 
ensure that its NLAA determinations are accurate. The Services 
disagree, however, with this commenter's characterization that EPA's 
approach is biased against the use of monitoring data. As explained in 
both the Overview Document and the Services' review of that document, 
although EPA's experience is that monitoring data are seldom 
sufficiently robust for risk assessment purposes given the limited 
range of pesticide use scenarios they represent, EPA's practice is to 
use monitoring data to estimate exposure when such data are relevant, 
quantifiable and reliable.
    Comment: EPA's ecological risk assessment methodology ignores 
potentially significant exposures through the dermal and inhalation 
routes. For example, terrestrial species could inhale pesticide spray 
or residues that have volatilized. The comments cited data to support 
the contention that air concentrations of pesticides are significant. 
Similarly, pesticide sprays could drift off-target and be deposited 
onto the fur or feathers of non-target organisms.
    Response: The Services agree that EPA's approach to ecological risk 
assessment generally does not quantify the potential dermal and 
inhalation exposure of non-target wildlife. As EPA

[[Page 47751]]

has discussed in its Overview Document, current analysis of terrestrial 
species focuses exclusively on dietary exposure or expresses exposures 
as a generalized potentially available biomass of pesticide on a per 
unit area basis. The Services agree that the dietary exposure analysis 
is appropriate as a means of estimating dietary exposure. Potential 
exposure through inhalation or dermal contact currently constitutes an 
unknown for which the risk assessment provides no available 
information. EPA has developed proposals to analyze inhalation and 
dermal exposure for birds in such a way that it may be added to dietary 
exposure, and thus used in the development of a risk quotient. See 
http://www.epa.gov/scipoly/sap/#march. Similar proposals for other 
classes of species are expected in the future. EPA reports that it has 
received one of two SAP peer-review reports on its proposals, and that, 
when it has received both reports, it will evaluate the peer review 
suggestions and formulate a plan for implementing the new modeling 
techniques. The Services encourage the development and implementation 
of these proposals, following external peer-review by the FIFRA SAP.
    The Services conclude that EPA's approach to incorporation of 
exposure estimates for non-oral routes is consistent with the ESA, in 
that EPA uses the best scientific and commercial information available. 
Pending implementation of these proposals, following external peer-
review by the FIFRA SAP, the data on dietary exposure remains the best 
available quantified information provided through existing models.
    Comment: EPA may underestimate exposure to the extent that 
pesticides are applied in ways or amounts other than as allowed on the 
label.
    Response: While the Services recognize that misuse may occur, we 
believe it is reasonable to assume pesticides are used lawfully unless 
data demonstrate a widespread and commonly recognized pattern of 
misuse. In fact, as the Overview Document states, many pesticides are 
typically applied at lesser rates and frequency than permitted by the 
label.
    Comment: EPA's exposure assessments do not account for movement of 
pesticides beyond the sites to which they are applied.
    Response: As noted in the Overview Document, EPA's exposure 
assessments do consider off-target movement of pesticides through run-
off and drift. These assessments are based on the concentration levels 
in or immediately adjacent to the site of application, where 
concentration levels would be highest. The Services agree that the 
modeling estimates and monitoring information used by EPA represent the 
best currently available information on exposure, and note that EPA has 
committed to adjusting these models where appropriate.
    Comment: The model used by EPA to estimate drift of pesticides, 
``AgDrift,'' is not completely transparent.
    Response: EPA has sought independent, external scientific peer 
review of AgDrift and has held public SAP meetings at which it 
explained the basic structure of AgDrift. See http://www.epa.gov/oscpmont/sap/1999/july/boom.pdf and http://www.epa.gov/oscpmont/sap/1997/december/spraydrift.htm. These meetings and EPA's supporting 
documents provide the public with a comprehensive description of the 
manner in which the model was constructed and the data on which it is 
based. As a general matter, EPA and the Services support and strive to 
achieve fully transparent scientific analyses. To the extent, however, 
that certain information provided to EPA and the Services is subject to 
release restrictions under federal law, the Services and EPA must abide 
by those restrictions. Further, even if such release restrictions 
apply, the ESA does not authorize the Services or EPA to reject 
consideration of such information if it otherwise constitutes the best 
scientific and commercial data available.
    Comment: EPA's exposure models have not been validated by 
monitoring data.
    Response: Since the commenter did not identify a specific model, 
the Services will only address the comment in general terms. The 
Services have reviewed the appendices accompanying EPA's Overview 
Document. These appendices describe the extensive reviews undertaken by 
EPA and external peer review of the models EPA uses to estimate 
exposure to pesticides. These reviews typically involve, among other 
things, comparisons of model estimates to data produced by monitoring 
of compounds in the environment. These comparisons, as well as the 
extensive external peer review records, support EPA's assertions its 
models are scientifically sound and are not likely to underestimate 
potential exposure to pesticides.
    Comment: EPA does not have the in-house biological expertise to 
accurately make ``may affect'' determinations. Another comment pointed 
out that EPA's Office of Pesticide Programs is the single best federal 
government entity with the greatest available in-house expertise and 
resources to apply towards endangered species/pesticide risk assessment 
and to make appropriate regulatory decisions that adequately protect 
endangered species from potential adverse effects of pesticides.
    Response: The Services note that all federal agencies are required 
to make ``may affect'' determinations, and are presumed to have the 
expertise to do so. Furthermore, EPA has a large staff of scientists 
well-trained in a range of disciplines, who collectively possess the 
expertise to make accurate assessments of the potential effects of 
pesticide use on listed species and critical habitat. Finally, in order 
for EPA to exercise the provisions of Sec.  402.45, the counterpart 
regulations require that the Services and EPA have in effect an 
Alternative Consultation Agreement that describes actions which the 
Services and EPA will take to ensure that personnel have adequate 
training to carry out their roles.
    Comment: EPA has expertise in assessing the fate and transport of 
pesticides. EPA has expertise in toxicity and ecology but not in 
evaluation of indirect or sublethal effects. The Services have such 
expertise.
    Response: The Services agree that EPA has expertise in assessing 
the toxicity and environmental fate and transport of pesticides. The 
Services also think the agency's expertise extends to the methodology 
used to assess indirect and sublethal effects, and that EPA has 
described its approach in its Overview Document.
    Comment: EPA does not have expertise in the life cycle, habitat 
needs, and locations of listed species.
    Response: The Services and EPA agree that the Services have greater 
expertise and knowledge about the biological attributes of listed 
species and their critical habitat than does EPA. Accordingly, the 
counterpart regulations contain three additional methods of achieving 
interagency cooperation that is the fundamental tenet of the section 7 
consultation process. Two of these methods deal directly with making 
the Services' expertise in species biology available to EPA. First, EPA 
could request the Services to provide available information describing 
the environmental baseline for each species or habitat that EPA 
determines may be affected by a FIFRA action. The Services would 
promptly provide such information. In addition, EPA may request a 
Service to designate a suitably-trained Service Representative to 
participate with EPA in development of an effects determination for one 
or more species or habitats. Third, EPA and the

[[Page 47752]]

Services will establish new procedures for regular and timely exchanges 
of scientific information to achieve accurate and informed decision-
making. In light of these methods, the Services conclude that EPA, 
through the Services, will have ready access to any additional 
biological information and insights that it would need to complete 
scientifically sound ecological risk assessments.
    Comment: EPA does not have ongoing relationships with local and 
State wildlife agencies.
    Response: EPA has worked with State and local wildlife agencies on 
a variety of issues, including providing protections for listed species 
and expects in the future to engage these and other stakeholders more 
widely in its pesticide regulatory programs. To the extent that EPA 
thinks that it needs help in developing these relationships, it can 
collaborate with the Services, either pursuant to the ACA or on a case-
by-case basis working with the designated Service Representative.
    Comment: Despite assertions to the contrary in the Overview 
Document, it will not be possible for EPA to perform ``site-specific'' 
risk assessments for listed species because data on species, habitat 
and pesticide use do not exist with which to perform such assessments. 
Moreover, EPA has not conducted adequate site-specific assessments in 
the past.
    Response: EPA has committed in the Overview Document to use a 
variety of sources to obtain information that would be relevant to a 
more refined, site-specific assessment. If detailed information is not 
available, EPA would make the best assessment possible with the best 
scientific and commercial information available and characterize any 
uncertainty in its ecological risk assessment.
    Comment: EPA has never implemented the approach to ecological risk 
assessment described in its Overview Document.
    Response: Although past risk assessments have not contained every 
element described in the Overview, the Overview Document reflects the 
approach to ecological risk assessment that EPA intends to use in the 
future. In fact, the Overview contains a number of new elements that 
will strengthen the agency's future evaluations of pesticide impacts on 
listed species. EPA, however, has routinely been using many of the 
methodologies described in the Overview Document for a number of years. 
While some of the methodologies are relatively recent, EPA has 
experience with all elements of the methodologies described and has 
begun developing effects determinations using these new methodologies. 
Further, the rule provides a number of mechanisms the Services can use 
to ensure that EPA's program for making effects determinations under 
new subpart D is consistent with the requirements of the ESA.
    Comment: Many of EPA's past assessments of ecological risks to 
listed species and critical habitat were not adequate under the ESA. 
Commenters cited several specific examples. The Services, in many past 
reviews of EPA's approach to ecological risk assessment, have 
disparaged EPA's methodologies and have concluded that they deal 
inadequately with a range of effects: sublethal effects of pesticide 
ingredients, indirect effects (alteration of the aquatic community 
structure), effects of inert ingredients and adjuvants, and additive 
and synergistic effects resulting from interactions among different 
chemical substances.
    Response: EPA has committed to make effects determinations using 
the approach to ecological risk assessments reflected in the Overview 
Document: this approach differs from the approaches EPA has used in the 
past. The Services believe EPA's approach to ecological risk assessment 
in the future, as set forth in the Overview Document, addresses the 
specific concerns in the comment. The Services believe that past 
determinations are not a relevant measure of EPA's ability to produce 
adequate effects determinations, and are confident that future effects 
determinations using the methodologies identified in the Overview 
Document will fully comport with the ESA. Comments and responses above 
address the specific concerns identified in these comments.
    Comment: EPA's risk assessment process has been demonstrated to be 
deficient in NRDC v. Whitman and other litigation.
    Response: The Services disagree. First, the litigation cited by the 
comment has not resulted in any finding that EPA's process for risk 
assessment is deficient, and second, the risk assessment processes at 
issue in those lawsuits involved human health, not ecological risks.
    Comment: The Government Accounting Office determined that EPA's 
risk assessment process is biased because it relies on advice of the 
Science Advisory Boards and it allows people to serve on the SAB who 
have conflicts of interest.
    Response: The Services find this comment irrelevant. The Services' 
conclusion about the adequacy of EPA's approach to ecological risk 
assessments rest on the Services' independent review of that approach 
rather than endorsement of an EPA appointed advisory committee. In 
addition, none of the Science Advisory Boards reviewed by the GAO dealt 
with scientific issues involving assessment of the ecological risks of 
pesticides. In fact, EPA does not rely on the SAB for peer review of 
scientific issues involving pesticides; a separate federal advisory 
committee, the FIFRA Scientific Advisory Panel reviews such issues.
    Comment: In the Overview Document, voluntary registrant label 
restrictions should be considered in screening-level risk assessment.
    Response: To the extent that this comment requests that EPA include 
voluntary registrant label restrictions as part of its action, this 
comment is outside the scope of the counterpart regulations because the 
Services defer to the action agency to define the scope of the action. 
The Services note, however, that EPA's standard approach to ecological 
risk assessment takes into account any mandatory restrictions on the 
pesticide labeling voluntarily offered by an applicant or registrant 
and accepted by EPA. EPA then bases the estimates of exposure on these 
restrictions.
    Comment: The proposed counterpart regulations must allow a more 
``real world'' assessment of actual risks, as opposed to assuming that 
all pesticides are generally bad for the environment (which is the 
current model).
    Response: The counterpart regulations do not prescribe use of any 
particular assumptions in EPA's approach to ecological risk assessment. 
The statute merely requires that effects determinations be based on the 
``best scientific and commercial data available.'' EPA's Overview 
Document discusses in detail what data EPA uses, how the agency uses 
these data, and when and how EPA employs assumptions. The Services have 
determined that EPA's approach is consistent with the statutory mandate 
to use the best available scientific and commercial information.

Section-by-Section Analysis

Section 402.40--Definitions

    Comment: The proposed counterpart regulations change the 
longstanding definition of ``best scientific and commercial data 
available'' and ``cumulative impacts'' in a way that is bad for 
species.
    Response: The Services note that ``best scientific and commercial 
data available'' is not defined in the ESA or part 402 of the 
regulations and do not

[[Page 47753]]

intend to change the way that phrase has been applied in the past. The 
Services also note that the term ``cumulative impacts'' is not used in 
the ESA or in the counterpart regulations. The Services use the term 
``cumulative effects'' as defined in Sec.  402.02 and specifically 
reaffirm that definition.
    Comment: The requirement for assessing cumulative effects should be 
waived or at least modified with a disclaimer noting that scientific 
methods for such assessment are not currently available. Other 
commenters requested clarification on the definition of ``cumulative 
effects'' or suggested that the definition was inappropriate.
    Response: The term ``cumulative effects'' is defined in Sec.  
402.02 of the regulations. These counterpart regulations do not change 
or waive the existing definition or the requirement to analyze such 
effects. The Services are aware that the existing scientific tools to 
assess the combined or additive effects of pesticides are very 
rudimentary. The ESA requires use of the best ``available'' scientific 
data, and EPA is not expected to provide more information than is 
currently available. At the same time, EPA should use what information 
is available on cumulative effects.
    Comment: The agencies should explicitly and broadly define the term 
``applicant'' to include any and all registrants of pesticide products 
(in the context of FIFRA section 2(y)), applicants for registration, as 
well as multiple persons (because of complex business and legal 
relationships) involved in a given FIFRA action.
    Response: There is a regulatory definition of ``applicant'' at 50 
CFR 402.02. The Services will defer to EPA to determine, consistent 
with this definition, who qualifies as an ``applicant'' when dealing 
with regulatory actions under FIFRA.
    Comment: The requirement that an effects determination contain the 
information described in Sec.  402.14(c)(1)-(6) should be revised so 
that unnecessary reprinting of paper is avoided.
    Response: The Services note that the effects determination 
submitted under Sec.  402.46 or 402.47 must contain the information 
described in Sec.  402.14(c)(1)-(6). However, it is not necessary to 
print a physical copy of all background information.
    Comment: Section 402.40(b)(3) of the counterpart regulations should 
be revised so that EPA is required to consider any information or 
recommendations from an applicant, and not just be allowed to consider 
this information.
    Response: Although EPA need not necessarily include all information 
in an effects determination, it is required to base its determinations 
on the best scientific and commercial data available. Therefore, to the 
extent that the information supplied by the applicant may be the best 
scientific and commercial data available, EPA is required to consider 
the information.
    Comment: Participation of multiple Service Representatives will 
adversely impact the efficiencies that the proposed counterpart 
regulations are seeking.
    Response: Authorizing the use of multiple Service Representatives 
is specifically intended to ensure efficiency, for example, by 
preventing delays if a specific Service Representative is unavailable. 
The Services will monitor this approach to avoid problems.
    Comment: ``Agency action'' should be defined as a specific use of 
an active ingredient.
    Response: The term ``action'' is defined in Sec.  402.02. The 
Services defer to action agencies to define the action, consistent with 
this definition.

Section 402.41--Purpose

    Comment: The penultimate sentence in Sec.  402.41 should be revised 
to recognize that in many cases data generated by pesticide registrants 
and applicants will be the only reliable scientific and commercial data 
available and that it alone will be enough to support ESA decision-
making. Furthermore, the phrase ``best scientific and commercial data 
available'' needs to be defined to clarify that ``best data'' does not 
mean ``all data'' and that suspect science should not be used in 
assessments.
    Response: The Services recognize the possibility that the best, and 
only, data available could come from pesticide registrants and 
applicants. The ESA requires use of the ``best scientific and 
commercial data available.'' The Services note that making a 
determination as to what constitutes ``best scientific and commercial 
data'' may require a review of data available beyond that generated by 
pesticide registrants and applicants.

Section 402.42--Scope and Applicability

    Comment: Section 402.42(a)(4) properly recognizes the potential 
value of the procedures that will be established by proposed Sec.  
402.47.
    Response: The Services agree with this comment.
    Comment: Additional detail should be included in the final 
counterpart regulations on the process to be followed for emergency 
exemptions.
    Response: The Services believe that further definition is not 
needed in the counterpart regulations. The procedures in Sec.  402.05 
have been applied in the past to address a wide range of issues and 
should be sufficient here.
    Comment: Delaying formal consultation is warranted for any type of 
emergency action. This provision should also apply to the effects 
determination EPA makes pursuant to ESA section 7(a)(2).
    Response: The Services agree that if an action appropriately meets 
the definition of an ``emergency,'' delay of any required formal 
consultation is authorized. The Services have historically allowed 
action agencies to meet their consultation obligations through informal 
consultation for actions determined to be NLAA. Consistent with this 
interpretation a determination of NLAA by EPA under Sec.  402.45 would 
be considered sufficient to meet the requirements of the counterpart 
regulations.
    Comment: The Services should provide a more detailed explanation 
regarding the application of the proposed counterpart regulations to 
emergency exemptions issued to States under section 18 of FIFRA and to 
special local need registrations issued by States under section 24(c) 
of FIFRA. ESA consultation obligations should not extend to either of 
these activities, or should be left to independent States.
    Response: Section 18 emergency exemptions issued by EPA are actions 
for the purposes of the ESA. Accordingly, EPA must satisfy the 
requirements of section 7(a)(2) with regard to those section 18 actions 
that may affect listed species. Emergency actions under FIFRA section 
18 will, in the overwhelming majority of instances, fall within the 
scope of emergency actions addressed in 50 CFR 402.05, and EPA may, 
therefore, utilize either the emergency consultation procedures or 
other available procedures (including the new procedures set forth in 
Sec. Sec.  402.45 and .46) to address its consultation obligations in a 
manner consistent with the need to expeditiously address the emergency.
    With regard to section 24(c) registrations, this comment notes that 
the States, rather than EPA, issue these registrations, and that, 
therefore, ESA consultation obligations should not extend to section 
24(c) registrations. It was not the Services' intention to suggest that 
State action in issuing section 24(c) registrations should be subject 
to the ESA consultation requirements. The consultation

[[Page 47754]]

obligation under section 7(a)(2) applies only to federal actions and 
federal agencies. States may, of course, contact the Services 
independently to discuss the potential effects of their actions on 
listed species. To the extent, however, that section 24(c) 
registrations are federal actions within EPA's purview, section 7(a)(2) 
applies to such registrations in the same manner as it applies to 
existing FIFRA section 3 registrations.
    Comment: ``Reinitiation'' should be more clearly explained in the 
final counterpart regulations with detailed narrative on when such a 
procedure would occur.
    Response: The counterpart regulations incorporate the existing 
rules in subpart B for reinitiation of consultation. These rules have 
been applied by federal agencies for almost two decades with relatively 
little difficulty, and should function adequately for FIFRA actions 
without further elaboration.
    Comment: Private and State data should be considered a viable 
alternative to the Services' and EPA's data.
    Response: Section 402.42(b) does not exclude any source from 
providing data. Information from all sources, including industry and 
States will be considered to satisfy the statutory requirement to use 
the best scientific and commercial data available.

Section 402.43--Interagency Exchanges of Information

    Comment: A month should be eliminated from the assessment process 
by requiring the Services to provide EPA with both information on the 
presence of listed species or their critical habitat and information 
describing the applicable environmental baseline for the species or 
habitat 30 days after EPA's written request.
    Response: The Services disagree with this comment. Baseline 
information is not always needed and therefore should not be asked for 
concurrently with presence of listed species or critical habitat data.
    Comment: Additional information should be provided to EPA with a 
species list: specifically, any use of a pesticide in controlling 
exotics for the benefit of listed species.
    Response: Species lists should include all listed species that may 
be affected positively or negatively.
    Comment: The proposed regulations do not indicate how EPA or other 
affected parties could enforce deadlines for the Services to respond to 
EPA requests for information. The commenter suggested addressing this 
by either including language stating that wherever EPA has asked a 
Service for a response, and the regulations set a time period for 
providing that response, lack of a Service response can be taken by EPA 
as concurrence in EPA's position or as evidence that the Service has 
nothing to add to the decision-making process.
    Response: The Services believe that the timelines noted in the 
counterpart regulations are sufficient enforcement. The Services are 
committed to meet all of the deadlines and expect to do so.

Section 402.44--Advance Coordination for FIFRA Action

    Comment: The proposed language that states the designated Service 
Representative ``shall normally be available to complete advance 
coordination with EPA within 60 days' allows for too much leeway. The 
word ``normally'' should be deleted.
    Response: The Services disagree with this comment. The word 
``normally'' is included because of potential staffing limitations and 
availability. The Services believe that 60 days is reasonable.
    Comment: A two-week timeframe for the Services to designate a 
Service Representative followed by a 60-day availability ``hold'' would 
add four months to the time it would take to implement an effects 
determination.
    Response: The commenter has misconstrued the regulation. The 
counterpart regulations call for a Service Representative to be 
designated and provided to EPA within 14 days. The regulations also 
indicate that advance coordination normally will be completed within 60 
days of the date of Service Representative designation. Further, the 
Services intend that Service Representatives will be available to work 
with EPA from the time they are designated until the coordination 
effort is complete.
    Comment: EPA should have the option of reconsidering its request 
should the process of advance coordination become overly burdensome 
with too many Service Representatives involved in the advance 
coordination of a given FIFRA action.
    Response: The Services note that nothing in the counterpart 
regulations prevents EPA from withdrawing a request for advance 
coordination.
    Comment: Participation of Service Representatives in the effects 
determination is unnecessary and will likely delay the process. Another 
commenter expressed the opposite view, suggesting that the counterpart 
regulations should require early Service involvement to reduce the 
amount of work by avoiding unnecessary investigation of species that 
would not be exposed to or harmed by the pesticide.
    Response: The Services believe participation by a Service 
Representative will lead to a more efficient consultation process, but 
believe that EPA should have the discretion to determine when to 
request early Service participation. If early participation by the 
Service does not prove helpful in a particular case, EPA retains the 
option of withdrawing its request.
    Comment: ``Sufficient detail,'' as used in Sec.  402.44(a), should 
be defined.
    Response: As stated in the counterpart regulations, EPA's 
description of the planned FIFRA action must be sufficient enough to 
``enable the Service to designate a representative with appropriate 
training and experience.'' The Services believe this text provides a 
basis for coordination with EPA on the issue.
    Comment: Deadlines should be set for EPA to produce an effects 
determination.
    Response: The Services disagree with this comment. It is not within 
the authority of the Services to tell EPA when effects determinations 
must be produced.

Section 402.45--Alternative Consultation on FIFRA Actions That Are Not 
Likely to Adversely Affect Listed Species or Critical Habitat

    Comment: The proposal would allow EPA to ignore the environmental 
baseline when making a NLAA determination for an action. Thus, EPA 
would not add direct, indirect, and cumulative effects to the baseline 
as required by 50 CFR 402.14(c)(4) and 402.02.
    Response: The commenter misconstrues the obligation of an action 
agency to consider the environmental baseline under the existing 
regulations in subpart B. Development of an environmental baseline is 
only required when the direct or indirect effects of a proposed action, 
in combination with any effects of interrelated or interdependent 
actions, are likely to adversely affect any listed species or 
designated critical habitat. If an action is not likely to adversely 
affect listed species or critical habitat (an NLAA determination) there 
would be no change to the environmental baseline and therefore no need 
to consider it.
    Comment: The language in Sec. 1A402.45(a) should be changed from 
``EPA need not initiate any additional consultation'' to ``need not 
initiate consultation'.
    Response: The Services disagree with this comment. Since Sec.  
402.45(a)

[[Page 47755]]

describes an alternative form of informal consultation, the suggested 
phrase would be inaccurate.
    Comment: Several elements of the ACA should be incorporated into 
the counterpart regulations: establishment of a framework for operation 
of the Coordination, Communication and Implementation Panel, 
identification of the number of members that will be drawn from the 
participating agencies and the positions from which those members will 
be chosen, requirement that all Panel meetings be open to the public, 
and the entire Guiding Principles section of the ACA. Furthermore, the 
final counterpart regulations should identify specifically who sits on 
the Coordination, Communication, and Implementation Panel, their 
respective roles, and the manner in which they are selected.
    Response: The Services agree that these are relevant issues but 
believe that it is inappropriate to address such issues in a Federal 
regulation. Because these matters should involve administrative, 
internal operating procedures affecting only the Services and EPA and 
because the procedures may change over time, the Services believe these 
matters are more appropriately addressed through the ACA.
    Comment: The Services violated the APA by failing to take comment 
from the public on the ACA. Because the draft ACA is not final, it 
offers no assurances that it represents the direction that EPA and the 
Services intend to go in a final ACA. The agencies are strongly urged 
to offer a more complete version of the ACA for public review and 
comment before it is finalized. Commenters expressed concern that the 
ACA might become a de facto regulation of pesticides.
    Response: The Services disagree with this comment. A draft version 
of the ACA was made available to the public during the public comment 
period of the proposed rule. Further, the proposal provides that the 
final ACA will be made available to the public. It is important to note 
that the ACA is not a regulation, but rather, is an agreement intended 
to describe an interagency process for ensuring and documenting 
compliance with the terms of the counterpart regulations. As such, it 
does not establish any standards for compliance with the ESA nor can it 
serve to regulate pesticides.
    Comment: Clarification is needed so that the procedures conducted 
by the Antimicrobial Division of OPP in its ecological risk assessments 
are included within the procedures that fulfill the requirements of the 
proposed 50 CFR 402.45(b)(2)(i).
    Response: There is no need to clarify the regulations because the 
regulations state that the ACA shall describe actions that EPA and the 
Services have taken to ensure that EPA determinations regarding the 
effects of its actions under FIFRA, which would include determinations 
by EPA's Antimicrobial division, are consistent with the ESA and 
applicable implementing regulations.
    Comment: EPA and Service personnel need to be sufficiently trained, 
including training of Service personnel by EPA in EPA's risk assessment 
process. Appropriate training and ``certification'' should be better 
described in the counterpart regulations.
    Response: The Services agree that sufficient training is important 
and note that the counterpart regulations call for the ACA to describe 
actions that EPA and the Services intend to take to ensure that EPA and 
Service personnel are adequately trained. The required training must be 
adequate for EPA and Service personnel to carry out their respective 
roles but flexibility is necessary to accommodate a variety of roles 
and evolution of responsibilities. The Services disagree that 
additional specification of the training should be included within the 
counterpart regulations themselves.
    Comment: EPA should not have to be trained by Service personnel on 
EPA's risk assessment process. Such a situation would be ``burdensome, 
bureaucratic and inefficient.''
    Response: The Services would not train EPA employees on EPA's risk 
assessment process. The purpose of the training program 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 Services. It is expected that the training program 
will rely upon the ESA Consultation Handbook as much as possible.
    Comment: Criteria should be included in the counterpart regulations 
or in the ACA for determining which ``new information'' and ``relevant 
scientific advances'' qualify as best available data. Although new data 
should include all quality data regardless of the results they support, 
``best available data'' are not equivalent to ``all data''.
    Response: The Services do not believe that it is appropriate to 
include language in the counterpart regulations for determining which 
``new information'' and ``relevant scientific advances'' qualify as 
best available data. The reader is referred to the earlier comment 
regarding Sec.  402.41 in this ``Section-by-Section Analysis'' for a 
discussion on ``best scientific and commercial data available.''
    Comment: An agreement should include procedures for reassessment of 
a NLAA determination and, as appropriate, reclassification to ``no 
effect'' or of ``likely to adversely affect'' with reclassification to 
NLAA or ``no effect.''
    Response: The Services do not believe that this is necessary. EPA, 
as the action agency, retains discretion to revisit its determination.
    Comment: The regulation does not define the ``necessary records'' 
that EPA must retain under Sec.  402.45(b)(2)(vi), leaving undefined 
the entire basis for oversight and therefore acceptance of EPA's 
performance.
    Response: The counterpart regulations do not instruct EPA and the 
Services which records EPA must maintain under the ACA, but leave to 
EPA and the Services discretion to determine which records are 
necessary to complete program evaluation. The Services expect, however, 
that the information EPA must already maintain for purposes of the 
Federal Records Act and judicial review will be sufficient to permit 
the Services to conduct appropriate periodic evaluations of EPA's 
process for making effects determinations.
    Comment: A requirement that EPA's annual report on NLAA 
determinations be made public should be incorporated into Sec.  402.45.
    Response: The Services note that Sec.  402.45(b)(4) states that 
``[t]he alternative consultation agreement and any related oversight or 
monitoring reports shall be made available to the public to the extent 
provided by law.''
    Comment: The provision in the counterpart regulations allowing 
deviation from the ACA undermines the value of the procedures and adds 
uncertainty as to whether listed species will be protected.
    Response: The counterpart regulations specify that the parties may 
depart from the ACA in a particular case to the extent deemed necessary 
by both the EPA and the Services, ensuring to the satisfaction of the 
Services that any departure from its terms will be in full compliance 
with section 7 and the counterpart regulations.
    Comment: Greater transparency of EPA's selection of data will 
reduce the burden of documentation.
    Response: EPA and the Services will continue to work 
collaboratively to ensure transparency of data selection and to 
minimize documentation burdens.

[[Page 47756]]

    Comment: The Services' review of implementation of counterpart 
regulations should be limited to reviewing whether EPA has followed the 
procedures for risk assessment agreed upon by the agencies. Allowing 
for review of all NLAA decisions appears to be inconsistent with the 
proposed counterpart regulations which say that EPA, not the Services, 
is responsible for the NLAA decisions.
    Response: The Services agree that their review of EPA's compliance 
with the counterpart regulations should focus on implementation of the 
overall approach and that EPA is responsible for its NLAA 
determinations. This review, however, will almost certainly involve 
examination of selected NLAA effects determinations. The focus of this 
review will be on how EPA is performing under the rule and the ACA and 
may result in recommendations designed to strengthen EPA's program. 
While these recommendations may be relevant to assessing the adequacy 
of particular NLAA determinations, the Services do not intend their 
oversight efforts to involve a determination-by-determination 
evaluation of all individual NLAA determinations.
    Comment: Allowing any agency to terminate the ACA provides no 
certainty to applicants, registrants or users that the provisions of 
the ACA and/or the counterpart regulations will be applicable in the 
future. The termination provisions should be ``tightened 
considerably.''
    Response: While the Services recognize the concern that Sec.  
402.45 may not be available for use in the future, the Services believe 
meaningful oversight of EPA's activities under this section requires 
authority to terminate the ACA if, ``EPA fails to comply with the 
requirements of this subpart, section 7 of the ESA, or the terms of the 
alternative consultation agreement.'' Since it is difficult to 
anticipate all possible future circumstances, the Services further 
believe that these standards provide needed flexibility.
    Comment: EPA should be given a period of time to take corrective 
action before the ACA could be terminated.
    Response: The Services do not believe such language is required in 
the counterpart regulations but note that Sec.  402.45(c) provides for 
possible corrective action.
    Comment: The Services should revise proposed Sec.  402.45(c) so 
that in the event that the Service Director exercises the authority to 
terminate an ACA, evaluations already underway in accordance with the 
existing ACA be allowed to continue. The commenter suggested that this 
would avoid disruption of schedules and waste of resources that 
applicants and EPA are likely to have committed.
    Response: The Services disagree with making such changes to the 
counterpart regulations. Any termination of an ACA would legally end 
EPA's authority to make NLAA determinations concerning evaluations in 
process without concurrence from the Services. The Services agree that 
in the event an ACA is terminated some disruption is possible but the 
Services intend to structure termination of the ACA in a way in which 
appropriately considers disruptions.
    Comment: If the Services terminate the ACA prior NLAAs should not 
be left in effect.
    Response: The Services disagree with this comment. It is possible 
that the ACA may be terminated for reasons independent of the likely 
validity of any past NLAA determinations, and therefore requiring all 
previous NLAA determinations to be revisited would be an inappropriate 
investment of limited resources, and detract from the ability of the 
Services and EPA to consult on actions likely to adversely affect 
listed species. The Services also note that under 402.45, EPA is 
responsible for the validity of its NLAA determinations and would 
continue to be responsible for those NLAA determinations if the ACA is 
later terminated. Information creating uncertainty regarding the basis 
for an NLAA determination may lead to EPA's reconsideration of the 
determination, or be the basis for reinitiation of consultation with 
the Services. Additionally, termination of the ACA may create 
appropriate grounds for the Services to request reinitiation of 
consultation on any specific NLAA determination.

Section 402.46--Optional Formal Consultation Procedure for FIFRA 
Actions

    Comment: Section 402.46(a) requires that a written request for 
consultation be accompanied by an ``effects determination prepared in 
accordance with Sec.  402.40(b),'' which does not say how the effects 
determination is to be prepared, just what it should include.
    Response: The Services do not intend to prescribe how EPA would 
prepare effects determinations; consequently, in response to this 
comment, the Services are changing the language in the final rule from 
``prepared in accordance with'' to ``as defined in.''
    Comment: The Services should provide EPA with any ``additional 
information'' at the time of notification under Sec.  402.46(b).
    Response: The counterpart regulations provide that the Services' 
shall describe the additional information in detail and shall identify 
a means for obtaining that information. The Services intend that EPA be 
able to obtain the additional information in an efficient manner, and 
believe it will frequently be more efficient for EPA to obtain it 
through an identified Website link or by accessing and retrieving 
selected values from a large database, for example, rather than through 
the Services. This provision, however, would not preclude a Service 
from providing the additional information directly, in cases where the 
Service feels that would be most efficient.
    Comment: EPA should be given the ability to dispute the validity 
and relevance of any additional information sought by the Services and 
be given the opportunity to continue with the consultation in the 
absence of the requested additional information.
    Response: As stated elsewhere in this preamble, EPA does have this 
ability. In response to a request for additional information EPA may 
choose to resubmit the original effects determination with an 
explanation as to why the requested information was not submitted.
    Comment: A deadline for EPA to complete a revised effects 
determination should be included in the final counterpart regulations.
    Response: The Services disagree with this comment and defer to EPA 
to decide how much time it needs to prepare a revised effects 
determination.
    Comment: EPA should be required to provide biological opinions to 
applicants, or at least inform applicants of their availability, as 
soon as the biological opinions are received from the Services. Another 
commenter stated that the chemical industry should not be given 
elevated consultation status, while public input is minimized.
    Response: Section 402.46(c)(2) of the proposed regulations provides 
that EPA shall, upon request of an applicant, provide the applicant 
with any draft biological opinion it receives from the Services. This 
section tracks the requirements of the existing consultation 
regulations at Sec.  402.14(g)(5). As with the existing regulations, it 
leaves to EPA the discretion to develop any additional processes it 
determines may be appropriate to make draft opinions available to 
applicants and to the public. In the Services' experience, action 
agencies have used this provision in the existing regulations to ensure 
that applicants and the public have the ability to provide input in the

[[Page 47757]]

development of final biological opinions. The Services do not believe 
there is a need, therefore, to create an additional obligation for EPA 
in this regard.
    Comment: State pesticide regulatory agencies should be designated 
as co-regulators with EPA and should be allowed full participation in 
the consultation process for species found in their States. These 
commenters noted that such agencies have primary responsibility for 
enforcing the misuse provisions of FIFRA as well as unique knowledge of 
agricultural and other pesticide related activity in their States and 
should, therefore, be involved in the development of mitigation 
measures for listed species.
    Response: The ESA does not provide the Services with authority to 
designate States as ``co-regulators.'' While the alternative 
consultation processes in the counterpart regulations apply only to 
EPA's effects determinations for FIFRA actions, they do not limit EPA's 
existing ability to obtain input from State pesticide regulatory 
agencies to better inform the consultation process. Further, the scope 
of this rule is limited to the consultation process itself and does 
not, therefore, address EPA's approach for participation by States and 
others in the development and implementation of mitigation measures 
under FIFRA.
    Comment: The procedures for applicant involvement during 
consultation should be formalized with a firm deadline for meeting with 
applicants and a requirement for written minutes of meetings attended 
by applicants.
    Response: The Services recognize the desirability of meeting 
promptly with applicants who request a meeting during consultation, but 
decline to require a fixed deadline for such meetings as it may not be 
possible to achieve in all cases due to scheduling conflicts and other 
duties. Likewise, taking formal minutes of every meeting with an 
applicant would be unduly burdensome; any applicant who attends a 
meeting with the Service can document the matters discussed at the 
meeting and submit any written meeting notes to the Service for 
inclusion in the record.
    Comment: The Services' authority to extend deadlines during 
consultation should be limited because they have overused their 
authority in the past.
    Response: The Services agree that consultations should be completed 
as quickly as possible, but do not agree fully with this comment. The 
counterpart rules permit the Services to extend a consultation deadline 
only as permitted by section 7(b)(1) of the ESA.
    Comment: To avoid additional delays, Sec.  402.46(e) should be 
expanded to make it clear that the specified officials have authority 
to make decisions based on whatever information has been put before 
them within the deadlines set forth in the counterpart regulations.
    Response: The ESA requires decisions to be based upon the best 
scientific and commercial data available. The Services believe the 
counterpart regulations establish procedures that will allow timely 
decisions based upon the best scientific and commercial data available.
    Comment: It is inappropriate that final actions under Sec.  
402.46(e) can only be approved by political appointees.
    Response: The comment misconstrues the counterpart regulations. 
Within each of the Services, decisions under Sec.  402.46(e) can be 
delegated to a senior-level non-political employee.

Section 402.47--Special Consultation Procedures for Complex FIFRA 
Actions

    Comment: Because procedures that are relatively routine in the 
world of FIFRA regulation are ``unusually complex'' in the context of 
the Services'' responsibilities, procedures described in proposed Sec.  
402.47 are likely to be more commonly invoked than some may expect.
    Response: The Services agree that this is a possibility.
    Comment: The successive effects determination process should be 
applied to new registrations in a manner that expedites approval of 
registrations for individual uses, use patterns, and use rates. 
Omitting evaluations of new pesticides under the phased approach to 
consultation will unduly delay issuance of many pending or future 
reduced-risk products. Another commenter expressed the opposing 
viewpoint that the counterpart regulations should expressly prohibit 
the use of this procedure for registration of new pesticides.
    Response: The Services do not believe that any changes to the 
proposed rule are warranted. 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. Thus, there should be no need to use the 
procedures in Sec.  402.47 for applications seeking to register new 
active ingredients or new uses of currently registered pesticides. The 
Services note that EPA and the applicant, of course, retain discretion 
to define a FIFRA action to relate only to a specific subset of 
pesticide uses proposed in an application. So long as EPA fulfills its 
responsibilities under the ESA for all listed species and critical 
habitat, defining a FIFRA action in this manner could achieve the 
stated goal of the comment. The Services will work with EPA to expedite 
consultations on new pesticides to the extent possible.
    Comment: EPA and the Services should explore ways to group listed 
species and/or pesticides in consultations. It might be possible to 
develop criteria to group listed species either taxonomically or by 
ecological function. Similarly, active ingredients could be organized 
into either chemically or toxicologically similar groups and consulted 
on by group, not individually.
    Response: The Services note it is within EPA's discretion to define 
the action. Batching similar actions together is permitted under 
subpart B and in fact, the Services encourage batching where 
appropriate. If EPA wishes, the flexibility provided by Sec.  402.47 
may be used to assess affects of pesticides on groups of taxonomically 
or ecologically similar species.
    Comment: Section 402.47 embodies too narrow a reading of the legal 
effects of a partial biological opinion, which should constitute a 
final biological opinion for the geographic area that was the subject 
of the opinion, providing immediate incidental take protection for the 
completed portions of a phased consultation. Also, effects 
determinations made by EPA should have incidental take protection.
    Response: The Services believe that Sec.  402.47 properly describes 
the legal effects of a partial biological opinion. Formal consultation 
on a proposed action is not concluded until all listed species or 
designated critical habitats that may be adversely affected by the 
action have been evaluated in a biological opinion. Incidental take 
protection is provided under section 7(b)(4) at the conclusion of 
consultation of the proposed action. However, 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 has discretion to determine the geographic limit of 
any FIFRA action it may propose, and the Services will consult on the 
action as proposed.

[[Page 47758]]

Revisions to the Proposed Rule

    In Sec.  402.40(g), we deleted the second sentence which read, 
``[t]he Service may designate more than one individual to serve jointly 
as a Service Representative.'' The change is made to remove redundancy 
with the first sentence which states that the ``Service Representative 
is the person or persons designated to participate in advance 
coordination as provided in this subpart.''
    In Sec.  402.45(c), we edited the penultimate sentence which read 
``[t]he Service Director retains discretion to terminate the 
alternative consultation agreement . . .'' to read, ``[t]he Service 
Director retains discretion to terminate or suspend the alternative 
consultation agreement . . .'' The change is made to clarify the 
statement and make it consistent with the final sentence of the 
subsection which begins, ``[t]ermination, suspension, or modification 
of an alternative consultation . . .''
    Language in Sec.  402.46(a) was changed from ``[t]he written 
request shall be accompanied by an effects determination prepared in 
accordance with Sec.  402.40(b)'' to ``[t]he written request shall be 
accompanied by an effects determination as defined in Sec.  
402.40(b).'' This change is intended to clarify that the Services do 
not intend to prescribe how EPA would prepare the effects 
determinations.

Required Determinations

Regulatory Planning and Review

    In accordance with Executive Order 12866, this document is a 
significant rule because of the legal or policy issues it has raised; 
it 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 rule will not have 
a significant economic impact on a substantial number of small entities 
for the following reasons.
    (1) The 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.
    (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 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

[[Page 47759]]

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 rule does not unduly 
burden the judicial system and meets the requirements of sections 3(a) 
and 3(b)(2) of the Order. We promulgate these counterpart regulations 
consistent with section 7 of the ESA.

Paperwork Reduction Act

    This rule will 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 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. 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, 
after preparation of an environmental assessment, that the action does 
not have any significant effects. A Finding Of No Significant Impact 
has been prepared.

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 
NativeAmerican 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.

Final Regulation Promulgation

0
For the reasons set forth in the preamble, the Services amend part 402, 
title 50 of the Code of Federal Regulations as follows:

PART 402--[AMENDED]

0
1. The authority citation for part 402 continues to read as follows:

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

0
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.
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

[[Page 47760]]

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.


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 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.

[[Page 47761]]

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 to 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 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 or suspend 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 as defined in 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.

[[Page 47762]]

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 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: July 27, 2004.
Julie A. MacDonald,
Acting Assistant Secretary for Fish and Wildlife and Parks, Department 
of the Interior.
William T. Hogarth,
Assistant Administrator for Fisheries, National Oceanic and Atmospheric 
Administration.
[FR Doc. 04-17654 Filed 8-4-04; 8:45 am]
BILLING CODE 4310-55-P