\[Code of Federal Regulations\]

\[Title 50, Volume 2, Parts 200 to 599\]

\[Revised as of October 1, 2000\]

From the U.S. Government Printing Office via GPO Access

TITLE 50\--WILDLIFE AND FISHERIES

CHAPTER IV\--JOINT REGULATIONS (UNITED STATES FISH AND WILDLIFE SERVICE,

DEPARTMENT OF THE INTERIOR AND NATIONAL MARINE FISHERIES SERVICE,

PART 402\--INTERAGENCY COOPERATION\--ENDANGERED SPECIES ACT OF 1973, AS
AMENDED\--Table of Contents

402.01 Scope.

402.02 Definitions.

402.03 Applicability.

402.04 Counterpart regulations.

402.05 Emergencies.

402.06 Coordination with other environmental reviews.

402.07 Designation of lead agency.

402.08 Designation of non-Federal representative.

402.09 Irreversible or irretrievable commitment of resources.

402.10 Conference on proposed species or proposed critical habitat.

402.11 Early consultation.

402.12 Biological assessments.

402.13 Informal consultation.

402.14 Formal consultation.

402.15 Responsibilities of Federal agency following issuance of a
biological opinion.

402.16 Reinitiation of formal consultation.

\[Page 376-377\]

Sec. 402.**01** Scope.

\(a\) This part interprets and implements sections 7(a)-(d) \[16 U.S.C.
1536(a)-(d)\] of the Endangered Species Act of 1973, as amended
(\`\`Act\'\'). Section 7(a) grants authority to and imposes requirements
upon Federal agencies regarding endangered or threatened species of
fish, wildlife, or plants (\`\`listed species\'\') and habitat of such
species that has been designated as critical (\`\`critical habitat\'\').
Section 7(a)(1) of the Act directs Federal agencies, in consultation
with and with the assistance of the Secretary of the Interior or of
Commerce, as appropriate, to utilize their authorities to further the
purposes of the Act by carrying out conservation programs for listed
species. Such affirmative conservation programs must comply with
applicable permit requirements (50 CFR parts 17, 220, 222, and 227) for
listed species and should be coordinated with the appropriate Secretary.
Section 7(a)(2) of the Act requires every Federal agency, in
consultation with and with the assistance of the Secretary, to insure
that any action it authorizes, funds, or carries out, in the United
States or upon the high seas, is not likely to jeopardize the continued
existence of any listed species or results in the destruction or adverse
modification of critical habitat. Section 7(a)(3) of the Act authorizes
a prospective permit or license applicant to request the issuing Federal
agency to enter into early consultation with the Service on a proposed
action to determine whether such action is likely to jeopardize the
continued existence of listed species or result in the destruction or
adverse modification of critical habitat. Section 7(a)(4) of the Act
requires Federal agencies to confer with the Secretary on any action
that is likely to jeopardize the continued existence of proposed species
or result in the destruction or adverse modification of proposed
critical habitat. 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

\[\[Page 377\]\]

listed species or critical habitat Biological assessments are required
under section 7(c) of the Act if listed species or critical habitat may
be present in the area affected by any major construction activity as
defined in Sec. 404.02. Section 7(d) of the Act prohibits Federal
agencies and applicants from making any irreversible or irretrievable
commitment of resources which has the effect of foreclosing the
formulation or implementation of reasonable and prudent alternatives
which would avoid jeopardizing the continued existence of listed species
or resulting in the destruction or adverse modification of critical
habitat. Section 7(e)-(o)(1) of the Act provide procedures for granting
exemptions from the requirements of section 7(a)(2). Regulations
governing the submission of exemption applications are found at 50 CFR
part 451, and regulations governing the exemption process are found at
50 CFR parts 450, 452, and 453.

\(b\) The U.S. Fish and Wildlife Service (FWS) and the National Marine
Fisheries Service (NMFS) share responsibilities for administering the
Act. The Lists of Endangered and Threatened Wildlife and Plants are
found in 50 CFR 17.11 and 17.12 and the designated critical habitats are
found in 50 CFR 17.95 and 17.96 and 50 CFR part 226. Endangered or
threatened species under the jurisdiction of the NMFS are located in 50
CFR 222.23(a) and 227.4. If the subject species is cited in 50 CFR
222.23(a) or 227.4, the Federal agency shall contact the NMFS. For all
other listed species the Federal Agency shall contact the FWS.

\[Page 377-379\]

Sec. 402.**02** Definitions.

Act means the Endangered Species Act of 1973, as amended, 16 U.S.C. 1531
et seq.

Action means all activities or programs of any kind authorized, funded,
or carried out, in whole or in part, by Federal agencies in the United
States or upon the high seas. Examples include, but are not limited to:

\(a\) actions intended to conserve listed species or their habitat;

\(b\) the promulgation of regulations;

\(c\) the granting of licenses, contracts, leases, easements,
rights-of-way, permits, or grants-in-aid; or

\(d\) actions directly or indirectly causing modifications to the land,
water, or air.

Action area means all areas to be affected directly or indirectly by the
Federal action and not merely the immediate area involved in the action.

Applicant refers to any person, as defined in section 3(13) of the Act,
who requires formal approval or authorization from a Federal agency as a
prerequisite to conducting the action.

Biological assessment refers to the information prepared by or under the
direction of the Federal agency concerning listed and proposed species
and designated and proposed critical habitat that may be present in the
action area and the evaluation potential effects of the action on such
species and habitat.

Biological opinion is the document that states the opinion of the
Service as to whether or not the Federal action is likely to jeopardize
the continued existence of listed species or result in the destruction
or adverse modification of critical habitat.

Conference is a process which involves informal discussions between a
Federal agency and the Service under section 7(a)(4) of the Act
regarding the impact of an action on proposed species or proposed
critical habitat and recommendations to minimize or avoid the adverse
effects.

Conservation recommendations are suggestions of the Service regarding
discretionary measures to minimize or avoid adverse effects of a
proposed action on listed species or critical habitat or regarding the
development of information.

Critical habitat refers to an area designated as critical habitat listed
in 50 CFR parts 17 or 226.

Cumulative effects are those effects of future State or private
activities, not involving Federal activities, that are reasonably
certain to occur within the action area of the Federal action subject to
consultation.

Designated non-Federal representative refers to a person designated by
the Federal agency as its representative to conduct informal
consultation and/or to prepare any biological assessment.

Destruction or adverse modification means a direct or indirect
alteration

\[\[Page 378\]\]

that appreciably diminishes the value of critical habitat for both the
survival and recovery of a listed species. Such alterations include, but
are not limited to, alterations adversely modifying any of those
physical or biological features that were the basis for determining the
habitat to be critical.

Director refers to the Assistant Administrator for Fisheries for the
National Oceanic and Atmospheric Administration, or his authorized
representative; or the Fish and Wildlife Service regional director, or
his authorized representative, for the region where the action would be
carried out.

Early consultation is a process requested by a Federal agency on behalf
of a prospective applicant under section 7(a)(3) of the Act.

Effects of the action refers to the direct and indirect effects of an
action on the species or critical habitat, together with the effects of
other activities that are interrelated or interdependent with that
action, that will be added to the environmental baseline. The
environmental baseline includes the past and present impacts of all
Federal, State, or private actions and other human activities in the
action area, the anticipated impacts of all proposed Federal projects in
the action area that have already undergone formal or early section 7
consultation, and the impact of State or private actions which are
contemporaneous with the consultation in process. Indirect effects are
those that are caused by the proposed action and are later in time, but
still are reasonably certain to occur. Interrelated actions are those
that are part of a larger action and depend on the larger action for
their justification. Interdependent actions are those that have no
independent utility apart from the action under consideration.

Formal consultation is a process between the Service and the Federal
agency that commences with the Federal agency\'s written request for
consultation under section 7(a)(2) of the Act and concludes with the
Service\'s issuance of the biological opinion under section 7(b)(3) of
the Act.

Incidental take refers to takings that result from, but are not the
purpose of, carrying out an otherwise lawful activity conducted by the
Federal agency or applicant.

Informal consultation is an optional process that includes all
discussions, correspondence, etc., between the Service and the Federal
agency or the designated non-Federal representative prior to formal
consultation, if required.

Jeopardize the continued existence of means to engage in an action that
reasonably would be expected, directly or indirectly, to reduce
appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or
distribution of that species.

Listed species means any species of fish, wildlife, or plant which has
been determined to be endangered or threatened under section 4 of the
Act. Listed species are found in 50 CFR 17.11-17.12.

Major construction activity is a construction project (or other
undertaking having similar physical impacts) which is a major Federal
action significantly affecting the quality of the human environment as
referred to in the National Environmental Policy Act \[NEPA, 42 U.S.C.
4332(2)(C)\].

Preliminary biological opinion refers to an opinion issued as a result
of early consultation.

Proposed critical habitat means habitat proposed in the Federal Register
to be designated or revised as critical habitat under section 4 of the
Act for any listed or proposed species.

Proposed species means any species of fish, wildlife, or plant that is
proposed in the Federal Register to be listed under section 4 of the
Act.

Reasonable and prudent alternatives refer to alternative actions
identified during formal consultation that can be implemented in a
manner consistent with the intended purpose of the action, that can be
implemented consistent with the scope of the Federal agency\'s legal
authority and jurisdiction, that is economically and technologically
feasible, and that the Director believes would avoid the likelihood of
jeopardizing the continued existence of listed species or resulting in
the destruction or adverse modification of critical habitat.

Reasonable and prudent measures refer to those actions the Director
believes

\[\[Page 379\]\]

necessary or appropriate to minimize the impacts, i.e., amount or
extent, of incidental take.

Recovery means improvement in the status of listed species to the point
at which listing is no longer appropriate under the criteria set out in
section 4(a)(1) of the Act.

Service means the U.S. Fish and Wildlife Service or the National Marine
Fisheries Service, as appropriate.

\[Page 379\]

Sec. 402.**03** Applicability.

Section 7 and the requirements of this part apply to all actions in
which there is discretionary Federal involvement or control.

\[Page 379\]

Sec. 402.**04** Counterpart regulations.

The consultation procedures set forth in this part 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. Such counterpart regulations shall be published in the Federal
Register in proposed form and shall be subject to public comment for at
least 60 days before final rules are published.

\[Page 379\]

Sec. 402.**05** Emergencies.

\(a\) Where emergency circumstances mandate the need to consult in an
expedited manner, consultation may be conducted informally through
alternative procedures that the Director determines to be consistent
with the requirements of sections 7(a)-(d) of the Act. This provision
applies to situations involving acts of God, disasters, casualties,
national defense or security emergencies, etc.

\(b\) Formal consultation shall be initiated as soon as practicable
after the emergency is under control. The Federal agency shall submit
information on the nature of the emergency action(s), the justification
for the expedited consultation, and the impacts to endangered or
threatened species and their habitats. The Service will evaluate such
information and issue a biological opinion including the information and
recommendations given during the emergency consultation.

\[Page 379\]

Sec. 402.**06** Coordination with other environmental reviews.

\(a\) Consultation, conference, and biological assessment procedures
under section 7 may be consolidated with interagency cooperation
procedures required by other statutes, such as the National
Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq., implemented at
40 CFR Parts 1500-1508) or the Fish and Wildlife Coordination Act (FWCA)
(16 U.S.C. 661 et seq.). Satisfying the requirements of these other
statutes, however, does not in itself relieve a Federal agency of its
obligations to comply with the procedures set forth in this part or the
substantive requirements of section 7. The Service will attempt to
provide a coordinated review and analysis of all environmental
requirements.

\(b\) Where the consultation or conference has been consolidated with
the interagency cooperation procedures required by other statutes such
as NEPA or FWCA, the results should be included in the documents
required by those statutes.

\[Page 379\]

Sec. 402.**07** Designation of lead agency.

When a particular action involves more than one Federal agency, the
consultation and conference responsibilities may be fulfilled through a
lead agency. Factors relevant in determining an appropriate lead agency
include the time sequence in which the agencies would become involved,
the magnitude of their respective involvement, and their relative
expertise with respect to the environmental effects of the action. The
Director shall be notified of the designation in writing by the lead
agency.

\[Page 379-380\]

Sec. 402.**08** Designation of non-Federal representative.

A Federal agency may designate a non-Federal representative to conduct
informal consultation or prepare a biological assessment by giving
written notice to the Director of such designation. If a permit or
license applicant is involved and is not the designated non-Federal
representative, then the applicant and Federal agency must agree on the
choice of the designated non-Federal representative. If a biological
assessment is prepared by the designated

\[\[Page 380\]\]

non-Federal representative, the Federal agency shall furnish guidance
and supervision and shall independently review and evaluate the scope
and contents of the biological assessment. The ultimate responsibility
for compliance with section 7 remains with the Federal agency.

\[Page 380\]

Sec. 402.**09** Irreversible or irretrievable commitment of resources.

After initiation or reinitiation of consultation required under section
7(a)(2) of the Act, the Federal agency and any applicant shall make no
irreversible or irretrievable commitment of resources with respect to
the agency action which has the effect of foreclosing the formulation or
implementation of any reasonable and prudent alternatives which would
avoid violating section 7(a)(2). This prohibition is in force during the
consultation process and continues until the requirements of section
7(a)(2) are satisfied. This provision does not apply to the conference
requirement for proposed species or proposed critical habitat under
section 7(a)(4) of the Act.

\[Page 380\]

Sec. 402.**10** Conference on proposed species or proposed critical
habitat.

\(a\) Each Federal agency shall confer with the Service on any action
which is likely to jeopardize the continued existence of any proposed
species or result in the destruction or adverse modification of proposed
critical habitat. The conference is designed to assist the Federal
agency and any applicant in identifying and resolving potential
conflicts at an early stage in the planning process.

\(b\) The Federal agency shall initiate the conference with the
Director. The Service may request a conference if, after a review of
available information, it determines that a conference is required for a
particular action.

\(c\) A conference between a Federal agency and the Service shall
consist of informal discussions concerning an action that is likely to
jeopardize the continued existence of the proposed species or result in
the destruction or adverse modification of the proposed critical habitat
at issue. Applicants may be involved in these informal discussions to
the greatest extent practicable. During the conference, the Service will
make advisory recommendations, if any, on ways to minimize or avoid
adverse effects. If the proposed species is subsequently listed or the
proposed critical habitat is designated prior to completion of the
action, the Federal agency must review the action to determine whether
formal consultation is required.

\(d\) If requested by the Federal agency and deemed appropriate by the
Service, the conference may be conducted in accordance with the
procedures for formal consultation in Sec. 402.14. An opinion issued at
the conclusion of the conference may be adopted as the biological
opinion when the species is listed or critical habitat is designated,
but only if no significant new information is developed (including that
developed during the rulemaking process on the proposed listing or
critical habitat designation) and no significant changes to the Federal
action are made that would alter the content of the opinion. An
incidental take statement provided with a conference opinion does not
become effective unless the Service adopts the opinion once the listing
is final.

\(e\) The conclusions reached during a conference and any
recommendations shall be documented by the Service and provided to the
Federal agency and to any applicant. The style and magnitude of this
document will vary with the complexity of the conference. If formal
consultation also is required for a particular action, then the Service
will provide the results of the conference with the biological opinion.

\[Page 380-381\]

Sec. 402.**11** Early consultation.

\(a\) Purpose. Early consultation is designed to reduce the likelihood
of conflicts between listed species or critical habitat and proposed
actions and occurs prior to the filing of an application for a Federal
permit or license. Although early consultation is conducted between the
Service and the Federal agency, the prospective applicant should be
involved throughout the consultation process.

\(b\) Request by prospective applicant. If a prospective applicant has
reason to

\[\[Page 381\]\]

believe that the prospective action may affect listed species or
critical habitat, it may request the Federal agency to enter into early
consultation with the Service. The prospective applicant must certify in
writing to the Federal agency that (1) it has a definitive proposal
outlining the action and its effects and (2) it intends to implement its
proposal, if authorized.

\(c\) Initiation of early consultation. If the Federal agency receives
the prospective applicant\'s certification in paragraph (b) of this
section, then the Federal agency shall initiate early consultation with
the Service. This request shall be in writing and contain the
information outlined in Sec. 402.14(c) and, if the action is a major
construction activity, the biological assessment as outlined in Sec.
402.12.

\(d\) Procedures and responsibilities. The procedures and
responsibilities for early consultation are the same as outlined in Sec.
402.14(c)-(j) for formal consultation, except that all references to the
\`\`applicant\'\' shall be treated as the \`\`prospective applicant\'\'
and all references to the \`\`biological opinion\'\' or the
\`\`opinion\'\' shall be treated as the \`\`preliminary biological
opinion\'\' for the purpose of this section.

\(e\) Preliminary biological opinion. The contents and conclusions of a
preliminary biological opinion are the same as for a biological opinion
issued after formal consultation except that the incidental take
statement provided with a preliminary biological opinion does not
constitute authority to take listed species.

\(f\) Confirmation of preliminary biological opinion as final biological
opinion. A preliminary biological opinion may be confirmed as a
biological opinion issued after formal consultation if the Service
reviews the proposed action and finds that there have been no
significant changes in the action as planned or in the information used
during the early consultation. A written request for confirmation of the
preliminary biological opinion should be submitted after the prospective
applicant applies to the Federal agency for a permit or license but
prior to the issuance of such permit or license. Within 45 days of
receipt of the Federal agency\'s request, the Service shall either:

\(1\) Confirm that the preliminary biological opinion stands as a final
biological opinion; or

\(2\) If the findings noted above cannot be made, request that the
Federal agency initiate formal consultation.

\[Page 381-383\]

Sec. 402.**12** Biological assessments.

\(a\) Purpose. A biological assessment shall evaluate the potential
effects of the action on listed and proposed species and designated and
proposed critical habitat and determine whether any such species or
habitat are likely to be adversely affected by the action and is used in
determining whether formal consultation or a conference is necessary.

\(b\) Preparation requirement. (1) The procedures of this section are
required for Federal actions that are \`\`major construction
activities\'\'; provided that a contract for construction was not
entered into or actual construction was not begun on or before November
10, 1978. Any person, including those who may wish to apply for an
exemption from section 7(a)(2) of the Act, may prepare a biological
assessment under the supervision of the Federal agency and in
cooperation with the Service consistent with the procedures and
requirements of this section. An exemption from the requirements of
section 7(a)(2) is not permanent unless a biological assessment has been
prepared.

\(2\) The biological assessment shall be completed before any contract
for construction is entered into and before construction is begun.

\(c\) Request for information. The Federal agency or the designated
non-Federal representative shall convey to the Director either (1) a
written request for a list of any listed or proposed species or
designated or proposed critical habitat that may be present in the
action area; or (2) a written notification of the species and critical
habitat that are being included in the biological assessment.

\(d\) Director\'s response. Within 30 days of receipt of the
notification of, or the request for, a species list, the Director shall
either concur with or revise the list or, in those cases where no list
has

\[\[Page 382\]\]

been provided, advise the Federal agency or the designated non-Federal
representative in writing whether, based on the best scientific and
commercial data available, any listed or proposed species or designated
or proposed critical habitat may be present in the action area. In
addition to listed and proposed species, the Director will provide a
list of candidate species that may be present in the action area.
Candidate species refers to any species being considered by the Service
for listing as endangered or threatened species but not yet the subject
of a proposed rule. Although candidate species have no legal status and
are accorded no protection under the Act, their inclusion will alert the
Federal agency of potential proposals or listings.

\(1\) If the Director advises that no listed species or critical habitat
may be present, the Federal agency need not prepare a biological
assessment and further consultation is not required. If only proposed
species or proposed critical habitat may be present in the action area,
then the Federal agency must confer with the Service if required under
Sec. 402.10, but preparation of a biological assessment is not required
unless the proposed listing and/or designation becomes final.

\(2\) If a listed species or critical habitat may be present in the
action area, the Director will provide a species list or concur with the
species list provided. The Director also will provide available
information (or references thereto) regarding these species and critical
habitat, and may recommend discretionary studies or surveys that may
provide a better information base for the preparation of an assessment.
Any recommendation for studies or surveys is not to be construed as the
Service\'s opinion that the Federal agency has failed to satisfy the
information standard of section 7(a)(2) of the Act.

\(e\) Verification of current accuracy of species list. If the Federal
agency or the designated non-Federal representative does not begin
preparation of the biological assessment within 90 days of receipt of
(or concurrence with) the species list, the Federal agency or the
designated non-Federal representative must verify (formally or
informally) with the Service the current accuracy of the species list at
the time the preparation of the assessment is begun.

\(f\) Contents. The contents of a biological assessment are at the
discretion of the Federal agency and will depend on the nature of the
Federal action. The following may be considered for inclusion:

\(1\) The results of an on-site inspection of the area affected by the
action to determine if listed or proposed species are present or occur
seasonally.

\(2\) The views of recognized experts on the species at issue.

\(3\) A review of the literature and other information.

\(4\) An analysis of the effects of the action on the species and
habitat, including consideration of cumulative effects, and the results
of any related studies.

\(5\) An analysis of alternate actions considered by the Federal agency
for the proposed action.

\(g\) Incorporation by reference. If a proposed action requiring the
preparation of a biological assessment is identical, or very similar, to
a previous action for which a biological assessment was prepared, the
Federal agency may fulfill the biological assessment requirement for the
proposed action by incorporating by reference the earlier biological
assessment, plus any supporting data from other documents that are
pertinent to the consultation, into a written certification that:

\(1\) The proposed action involves similar impacts to the same species
in the same geographic area;

\(2\) No new species have been listed or proposed or no new critical
habitat designated or proposed for the action area; and

\(3\) The biological assessment has been supplemented with any relevant
changes in information.

\(h\) Permit requirements. If conducting a biological assessment will
involve the taking of a listed species, a permit under section 10 of the
Act (16 U.S.C. 1539) and part 17 of this title (with respect to species
under the jurisdiction of the FWS) or parts 220, 222, and 227 of this
title (with respect to species under the jurisdiction of the NMFS) is
required.

\[\[Page 383\]\]

\(i\) Completion time. The Federal agency or the designated non- Federal
representative shall complete the biological assessment within 180 days
after its initiation (receipt of or concurrence with the species list)
unless a different period of time is agreed to by the Director and the
Federal agency. If a permit or license applicant is involved, the
180-day period may not be extended unless the agency provides the
applicant, before the close of the 180-day period, with a written
statement setting forth the estimated length of the proposed extension
and the reasons why such an extension is necessary.

\(j\) Submission of biological assessment. The Federal agency shall
submit the completed biological assessment to the Director for review.
The Director will respond in writing within 30 days as to whether or not
he concurs with the findings of the biological assessment. At the option
of the Federal agency, formal consultation may be initiated under Sec.
402.14(c) concurrently with the submission of the assessment.

\(k\) Use of the biological assessment. (1) The Federal agency shall use
the biological assessment in determining whether formal consultation or
a conference is required under Sec. 402.14 or Sec. 402.10, respectively.
If the biological assessment indicates that there are no listed species
or critical habitat present that are likely to be adversely affected by
the action and the Director concurs as specified in paragraph (j) of
this section, then formal consultation is not required. If the
biological assessment indicates that the action is not likely to
jeopardize the continued existence of proposed species or result in the
destruction or adverse modification of proposed critical habitat, and
the Director concurs, then a conference is not required.

\(2\) The Director may use the results of the biological assessment in
(i) determining whether to request the Federal agency to initiate formal
consultation or a conference, (ii) formulating a biological opinion, or
(iii) formulating a preliminary biological opinion.

\[Page 383\]

Sec. 402.**13** Informal consultation.

\(a\) Informal consultation is an optional process that includes all
discussions, correspondence, etc., between the Service and the Federal
agency or the designated non-Federal representative, designed to assist
the Federal agency in determining whether formal consultation or a
conference is required. If during informal consultation it is determined
by the Federal agency, with the written concurrence of the Service, that
the action is not likely to adversely affect listed species or critical
habitat, the consultation process is terminated, and no further action
is necessary.

\(b\) During informal consultation, the Service may suggest
modifications to the action that the Federal agency and any applicant
could implement to avoid the likelihood of adverse effects to listed
species or critical habitat.

\[Page 383-386\]

Sec. 402.**14** Formal consultation.

\(a\) Requirement for formal consultation. Each Federal agency shall
review its actions at the earliest possible time to determine whether
any action may affect listed species or critical habitat. If such a
determination is made, formal consultation is required, except as noted
in paragraph (b) of this section. The Director may request a Federal
agency to enter into consultation if he identifies any action of that
agency that may affect listed species or critical habitat and for which
there has been no consultation. When such a request is made, the
Director shall forward to the Federal agency a written explanation of
the basis for the request.

\(b\) Exceptions. (1) A Federal agency need not initiate formal
consultation if, as a result of the preparation of a biological
assessment under Sec. 402.12 or as a result of informal consultation
with the Service under Sec. 402.13, the Federal agency determines, with
the written concurrence of the Director, that the proposed action is not
likely to adversely affect any listed species or critical habitat.

\(2\) A Federal agency need not initiate formal consultation if a
preliminary biological opinion, issued after early consultation under
Sec. 402.11, is confirmed as the final biological opinion.

\[\[Page 384\]\]

\(c\) Initiation of formal consultation. A written request to initiate
formal consultation shall be submitted to the Director and shall
include:

\(1\) A description of the action to be considered;

\(2\) A description of the specific area that may be affected by the
action;

\(3\) A description of any listed species or critical habitat that may
be affected by the action;

\(4\) A description of the manner in which the action may affect any
listed species or critical habitat and an analysis of any cumulative
effects;

\(5\) Relevant reports, including any environmental impact statement,
environmental assessment, or biological assessment prepared; and

\(6\) Any other relevant available information on the action, the
affected listed species, or critical habitat.

Formal consultation shall not be initiated by the Federal agency until
any required biological assessment has been completed and submitted to
the Director in accordance with Sec. 402.12. Any request for formal
consultation may encompass, subject to the approval of the Director, a
number of similar individual actions within a given geographical area or
a segment of a comprehensive plan. This does not relieve the Federal
agency of the requirements for considering the effects of the action as
a whole.

\(d\) Responsibility to provide best scientific and commercial data
available. The Federal agency requesting formal consultation shall
provide the Service with the best scientific and commercial data
available or which can be obtained during the consultation for an
adequate review of the effects that an action may have upon listed
species or critical habitat. This information may include the results of
studies or surveys conducted by the Federal agency or the designated
non-Federal representative. The Federal agency shall provide any
applicant with the opportunity to submit information for consideration
during the consultation.

\(e\) Duration and extension of formal consultation. Formal consultation
concludes within 90 days after its initiation unless extended as
provided below. If an applicant is not involved, the Service and the
Federal agency may mutually agree to extend the consultation for a
specific time period. If an applicant is involved, the Service and the
Federal agency may mutually agree to extend the consultation provided
that the Service submits to the applicant, before the close of the 90
days, a written statement setting forth:

\(1\) The reasons why a longer period is required,

\(2\) The information that is required to complete the consultation, and

\(3\) The estimated date on which the consultation will be completed.

A consultation involving an applicant cannot be extended for more than
60 days without the consent of the applicant. Within 45 days after
concluding formal consultation, the Service shall deliver a biological
opinion to the Federal agency and any applicant.

\(f\) Additional data. When the Service determines that additional data
would provide a better information base from which to formulate a
biological opinion, the Director may request an extension of formal
consultation and request that the Federal agency obtain additional data
to determine how or to what extent the action may affect listed species
or critical habitat. If formal consultation is extended by mutual
agreement according to Sec. 402.**14**(e), the Federal agency shall
obtain, to the extent practicable, that data which can be developed
within the scope of the extension. The responsibility for conducting and
funding any studies belongs to the Federal agency and the applicant, not
the Service. The Service\'s request for additional data is not to be
construed as the Service\'s opinion that the Federal agency has failed
to satisfy the information standard of section 7(a)(2) of the Act. If no
extension of formal consultation is agreed to, the Director will issue a
biological opinion using the best scientific and commercial data
available.

\(g\) Service responsibilities. Service responsibilities during formal
consultation are as follows:

\(1\) Review all relevant information provided by the Federal agency or
otherwise available. Such review may include an on-site inspection of
the action area with representatives of the Federal agency and the
applicant.

\[\[Page 385\]\]

\(2\) Evaluate the current status of the listed species or critical
habitat.

\(3\) Evaluate the effects of the action and cumulative effects on the
listed species or critical habitat.

\(4\) Formulate its biological opinion as to whether the action, taken
together with cumulative effects, is likely to jeopardize the continued
existence of listed species or result in the destruction or adverse
modification of critical habitat.

\(5\) Discuss with the Federal agency and any applicant the Service\'s
review and evaluation conducted under paragraphs (g)(1) through (3) of
this section, the basis for any finding in the biological opinion, and
the availability of reasonable and prudent alternatives (if a jeopardy
opinion is to be issued) that the agency and the applicant can take to
avoid violation of section (a)(2). The Service will utilize the
expertise of the Federal agency and any applicant in identifying these
alternatives. If requested, the Service shall make available to the
Federal agency the draft biological opinion for the purpose of analyzing
the reasonable and prudent alternatives. The 45-day period in which the
biological opinion must be delivered will not be suspended unless the

Federal agency secures the written consent of the applicant to an
extension to a specific date. The applicant may request a copy of the
draft opinion from the Federal agency. All comments on the draft
biological opinion must be submitted to the Service through the Federal
agency, although the applicant may send a copy of its comments directly
to the Service. The Service will not issue its biological opinion prior
to the 45-day or extended deadline while the draft is under review by
the Federal agency. However, if the Federal agency submits comments to
the Service regarding the draft biological opinion within 10 days of the
deadline for issuing the opinion, the Service is entitled to an
automatic 10-day extension on the deadline.

\(6\) Formulate discretionary conservation recommendations, if any,
which will assist the Federal agency in reducing or eliminating the
impacts that its proposed action may have on listed species or critical
habitat.

\(7\) Formulate a statement concerning incidental take, if such take may
occur.

\(8\) In formulating its biological opinion, any reasonable and prudent
alternatives, and any reasonable and prudent measures, the Service will
use the best scientific and commercial data available and will give
appropriate consideration to any beneficial actions taken by the Federal
agency or applicant, including any actions taken prior to the initiation
of consultation.

\(h\) Biological opinions. The biological opinion shall include:

\(1\) A summary of the information on which the opinion is based;

\(2\) A detailed discussion of the effects of the action on listed
species or critical habitat; and

\(3\) The Service\'s opinion on 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 (a \`\`jeopardy
biological opinion\'\'); or, the action is not likely to jeopardize the
continued existence of a listed species or result in the destruction or
adverse modification of critical habitat (a \`\`no jeopardy\'\'
biological opinion). A \`\`jeopardy\'\' biological opinion shall include
reasonable and prudent alternatives, if any. If the Service is unable to
develop such alternatives, it will indicate that to the best of its
knowledge there are no reasonable and prudent alternatives.

\(i\) Incidental take. (1) In those cases where the Service concludes
that an action (or the implementation of any reasonable and prudent
alternatives) and the resultant incidental take of listed species will
not violate section 7(a)(2), and, in the case of marine mammals, where
the taking is authorized pursuant to section 101(a)(5) of the Marine
Mammal Protection Act of 1972, the Service will provide with the
biological opinion a statement concerning incidental take that:

\(i\) Specifies the impact, i.e., the amount or extent, of such
incidental taking on the species;

\(ii\) Specifies those reasonable and prudent measures that the Director
considers necessary or appropriate to minimize such impact;

\[\[Page 386\]\]

\(iii\) In the case of marine mammals, specifies those measures that are
necessary to comply with section 101(a)(5) of the Marine Mammal
Protection Act of 1972 and applicable regulations with regard to such
taking;

\(iv\) Sets forth the terms and conditions (including, but not limited
to, reporting requirements) that must be complied with by the Federal
agency or any applicant to implement the measures specified under
paragraphs (i)(1)(ii) and (i)(1)(iii) of this section; and

\(v\) Specifies the procedures to be used to handle or dispose of any
individuals of a species actually taken.

\(2\) Reasonable and prudent measures, along with the terms and
conditions that implement them, cannot alter the basic design, location,
scope, duration, or timing of the action and may involve only minor
changes.

\(3\) In order to monitor the impacts of incidental take, the Federal
agency or any applicant must report the progress of the action and its
impact on the species to the Service as specified in the incidental take
statement. The reporting requirements will be established in accordance
with 50 CFR 13.45 and 18.27 for FWS and 50 CFR 220.45 and 228.5 for
NMFS.

\(4\) If during the course of the action the amount or extent of
incidental taking, as specified under paragraph (i)(1)(i) of this
Section, is exceeded, the Federal agency must reinitiate consultation
immediately.

\(5\) Any taking which is subject to a statement as specified in
paragraph (i)(1) of this section and which is in compliance with the
terms and conditions of that statement is not a prohibited taking under
the Act, and no other authorization or permit under the Act is required.

\(j\) Conservation recommendations. The Service may provide with the
biological opinion a statement containing discretionary conservation
recommendations. Conservation recommendations are advisory and are not
intended to carry any binding legal force.

\(k\) Incremental steps. When the action is authorized by a statute that
allows the agency to take incremental steps toward the completion of the
action, the Service shall, if requested by the Federal agency, issue a
biological opinion on the incremental step being considered, including
its views on the entire action. Upon the issuance of such a biological
opinion, the Federal agency may proceed with or authorize the
incremental steps of the action if:

\(1\) The biological opinion does not conclude that the incremental step
would violate section 7(a)(2);

\(2\) The Federal agency continues consultation with respect to the
entire action and obtains biological opinions, as required, for each
incremental step;

\(3\) The Federal agency fulfills its continuing obligation to obtain
sufficient data upon which to base the final biological opinion on the
entire action;

\(4\) The incremental step does not violate section 7(d) of the Act
concerning irreversible or irretrievable commitment of resources; and

\(5\) There is a reasonable likelihood that the entire action will not
violate section 7(a)(2) of the Act.

\(l\) Termination of consultation. (1) Formal consultation is terminated
with the issuance of the biological opinion.

\(2\) If during any stage of consultation a Federal agency determines
that its proposed action is not likely to occur, the consultation may be
terminated by written notice to the Service.

\(3\) If during any stage of consultation a Federal agency determines,
with the concurrence of the Director, that its proposed action is not
likely to adversely affect any listed species or critical habitat, the
consultation is terminated.

\[Page 386-387\]

Sec. 402.**15** Responsibilities of Federal agency following issuance of
a biological opinion.

\(a\) Following the issuance of a biological opinion, the Federal agency
shall determine whether and in what manner to proceed with the action in
light of its section 7 obligations and the Service\'s biological
opinion.

\(b\) If a jeopardy biological opinion is issued, the Federal agency
shall notify the Service of its final decision on the action.

\[\[Page 387\]\]

\(c\) If the Federal agency determines that it cannot comply with the
requirements of section 7(a)(2) after consultation with the Service, it
may apply for an exemption. Procedures for exemption applications by

Federal agencies and others are found in 50 CFR part 451.

\[Page 387\]

Sec. 402.**16** Reinitiation of formal consultation.

Reinitiation of formal consultation is required and shall be requested
by the Federal agency or by the Service, where discretionary

Federal involvement or control over the action has been retained or is
authorized by law and:

\(a\) If the amount or extent of taking specified in the incidental take
statement is exceeded;

\(b\) If new information reveals effects of the action that may affect
listed species or critical habitat in a manner or to an extent not
previously considered;

\(c\) If the identified action is subsequently modified in a manner that
causes an effect to the listed species or critical habitat that was not
considered in the biological opinion; or

\(d\) If a new species is listed or critical habitat designated that may
be affected by the identified action.