[Federal Register Volume 65, Number 12 (Wednesday, January 19, 2000)]
[Notices]
[Pages 2977-2979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Establishment by the National Institutes of Health of Categorical 
Exclusions Under the National Environmental Policy Act

AGENCY:  National Institutes of Health, DHHS.

ACTION:  Notice of establishment by the NIH of categorical exclusions 
under the National Environmental Policy Act.

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SUMMARY:  The NIH is establishing procedures governing compliance with 
the National Environmental Policy Act of 1969 and the Council on 
Environmental Quality's implementing regulations. This notice lists the 
categories of actions taken by the NIH that normally do not require the 
preparation of either an environmental impact statement or an 
environmental assessment under the National Environmental Policy Act. 
This list has been prepared in accordance with the Council on 
Environmental Quality's regulations and with Chapter 30 of the 
Department of Health and Human Services (DHHS) General Administration 
Manual (GAM). These exclusions apply to all NIH organizations and 
activities.

DATES:  These categorical exclusions are effective January 19, 2000.

FOR FURTHER INFORMATION CONTACT:  Joseph G. Hugo, P.E., Chief, 
Pollution Control Section, Division of Safety, Office of Research 
Services, National Institutes of Health, Building 13, Room 2W64, 
Bethesda, Maryland 20892. Telephone 301-496-7775, FAX 301-480-8056, E-
mail Address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In an August 20, 1999, Federal Register notice (64 FR 45558), the 
NIH published for comment the agency's proposed categorical exclusions 
for actions taken by the NIH that the agency has determined do not 
individually or cumulatively have a significant effect on the quality 
of the human environment. The NIH also submitted its proposed 
categorical exclusions to the Council on Environmental Quality (CEQ) 
for its review and comment. The National Environmental Policy Act of 
1969 (NEPA), as amended, 42 U.S.C. 4321 et seq., and CEQ's regulations 
implementing NEPA, 40 CFR Parts 1500-1508, mandate that agencies 
perform environmental reviews of their actions. CEQ's regulations also 
require that agencies establish procedures governing categories of 
actions that are normally excluded from NEPA review because they do not 
individually or cumulatively have a significant effect on the human 
environment. 40 CFR 1508.4.
    After reviewing the types of actions that it takes, the NIH is 
providing notice of the actions that will normally be categorically 
excluded from further environmental review because individually and 
cumulatively they will not have a significant effect on the human 
environment. If a proposed action is included in one of the categories 
but extraordinary circumstances as described in section D of this 
notice apply, an environmental review will be performed.

II. Comments on the Proposed Categorical Exclusions

    The NIH received one comment on its proposed categorical 
exclusions. CEQ did not provide any comments. A nonprofit animal 
advocacy group raised a concern with one of the NIH's proposed 
functional exclusions, which applied to, ``The identification, 
collection, testing, and distribution of substances and living 
organisms for research purposes.'' The commentator was concerned that 
the terms ``substances'' and ``living organisms'' are unacceptably 
vague and that this proposed exclusion could be read to exclude from 
environmental review the collection and distribution of animals. The 
comment cited an estimate by the United States Department of 
Agriculture/Animal Plant Health Inspection Service that 17 to 22 
million animals are used in research each year and indicated that the 
action of collecting and distributing this many animals would have a 
cumulative effect on the human environment.
    The NIH's intent in establishing this exclusion was primarily to 
exclude from NEPA review agency actions involving the collection and 
distribution of materials and reagents used in the research of human 
diseases or those which may contain unknown or unstudied constituents 
that could prove useful in the diagnosis and/or treatment of human 
disease(s). The NIH did not intend this exclusion to cover all actions 
involving animals. Consistent with the concerns about vagueness, the 
proposed categorical exclusion has been rewritten to clarify what 
actions it covers. The revised exclusion states: ``The identification, 
collection, testing, and distribution of chemicals, drugs, biologicals, 
plants or plant derivatives, microorganisms, and/or cell cultures for 
use in the research, diagnosis, and/or treatment of human diseases.'' 
This

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exclusion is not intended to apply to the collection or distribution of 
animals for research purposes. Although the NIH has rewritten the 
exclusion in response to the comment to more clearly explain which 
actions it covers, the NIH believes that at least part of the 
commentator's concerns are based on a misunderstanding of NIH actions. 
The proposed exclusion, like all the proposed exclusions, would apply 
only to actions taken by the agency itself, not to actions taken by 
other Federal agencies or by any other party. Thus, the comment's 
reliance on an estimate of the total number of animals used in research 
each year by all researchers is misplaced. Also, the commentator was 
concerned that under the proposed exclusion, ``the NIH could exempt 
threatened and endangered species during all phases of research.'' The 
NIH recognizes that extraordinary circumstances may require an 
environmental review of an action otherwise within a categorical 
exclusion, and one of the extraordinary circumstances proposed and 
retained in this final list of categorical exclusions is an action's 
``Possible impact on an endangered or threatened species.''
    The complete and final list of NIH's categorical exclusions 
established under NEPA and CEQ's implementing regulations follows:

Contents

A. General exclusions
B. Functional exclusions
C. Program exclusions
D. Extraordinary circumstances

A. General Exclusions

    Subject to a review for extraordinary circumstances, NIH will not 
perform an environmental review of actions excluded by regulation from 
NEPA review. NIH will also not perform an environmental review of 
actions categorically excluded from NEPA review in DHHS GAM Chapter 30.

B. Functional Exclusions

    The following actions are normally excluded from NEPA review, 
subject to a review for extraordinary circumstances.
    1. Routine administrative and management support, including budget 
and finance, planning, procurement of supplies and services, management 
and oversight of grants and other funding instruments, legal counsel, 
public affairs, program evaluation, travel, and human resources 
management.
    2. Maintenance, including repairs necessary to ensure the operation 
of existing facilities, grounds maintenance, and the decontamination of 
laboratory or other space and equipment.
    3. Acquisition of space by lease and modifications of leases, when 
the use of the space will comply with all applicable Federal, State, 
and local laws, including all environmental protection and zoning laws, 
and lease extensions and terminations.
    4. Relocation of employees into existing Government-owned or 
Government-leased space.
    5. Facility planning and design.
    6. Construction, or construction pursuant to a lease, of 12,000 
square feet or less of occupiable space.
    7. Interior construction and renovation of NIH facilities.
    8. The acquisition, sale, release, disposal, abandonment, closure, 
or transfer of real or personal property, provided that the action does 
not violate applicable Federal, State, or local laws, including 
historical preservation laws.
    9. Acquisition of equipment and the repair or replacement of NIH-
owned equipment.
    10. Acquisition, installation, maintenance, and operation of 
utility and communications systems, data processing cables, and similar 
electronic equipment.
    11. Packaging, storage, and disposal of hazardous substances, 
including low-level radioactive, medical, and chemical waste materials 
generated by intramural research activities, provided that the waste is 
packed, stored, and disposed of in compliance with all applicable 
Federal, State, and local laws.
    12. The identification, collection, testing, and distribution of 
chemicals, drugs, biologicals, plants or plant derivatives, 
microorganisms, and/or cell cultures for use in the research, 
diagnosis, and/or treatment of human diseases.
    13. Research and training activities that are conducted in NIH 
facilities: By or under the supervision of NIH employees; under the 
Stevenson-Wydler Technology Innovation Act of 1980, as amended, 15 
U.S.C. 3701 et seq.; or in accordance with 45 CFR part 9.
    14. The issuance of revocable licenses, use permits, and easements 
allowing outside parties to use NIH facilities.
    15. Filing for, obtaining, licensing, enforcing, and protecting 
intellectual property rights arising from NIH-conducted or NIH-
supported research or other activities.
    16. Actions taken to comply with requirements of applicable 
legislation or regulations (e.g., meet emissions requirements 
established pursuant to Clean Air Act).
    17. The preparation and submission of proposals for legislation, or 
major recommendations or reports to Congress on proposals for 
legislation, that, based on reasonable judgment, will not establish or 
modify programs that will have a significant effect on the quality of 
the human environment.
    18. The awarding, renewal, suspension, termination, or 
discontinuance of: Collaborative research agreements, including 
Cooperative Research and Development Agreements (CRADA) established 
under the Stevenson-Wydler Technology Innovation Act of 1980, as 
amended, 15 U.S.C. 3701 et seq.; contracts; cooperative agreements; 
grants; and interagency agreements entered into by the NIH pursuant to 
the Economy Act, 31 U.S.C. 1535. For those contracts, cooperative 
agreements, grants, and interagency agreements that involve 
construction of more than 12,000 square feet of occupiable space, 
recipients of NIH funds must certify that they are in compliance with 
all Federal, State, and local environmental laws and must, as 
prescribed by NIH, perform all environmental reviews required by NEPA, 
including preparing environmental assessments and, if necessary, 
environmental impact statements, and submit these documents to the NIH 
for review, approval and adoption.
    19. All actions undertaken in preparing for and conducting 
litigation.
    20. The collection, processing, retention, evaluation and 
dissemination, including publication, of data and other information, 
including the acquisition and management of resources necessary to 
carry out those functions.
    21. Proposing and adopting guidelines.
    22. Traffic management measures, including the installation and 
operation of traffic control and safety devices and actions designed to 
control or reduce the number of motor vehicles coming onto the NIH 
Bethesda campus.
    23. Actions taken to respond to public health emergencies.

C. Program Exclusion

    The DHHS procedures on environmental review of agency actions 
authorize the establishment of a categorical exclusion for programs 
within an agency that will not have a significant effect on the human 
environment. Actions taken by the following NIH organizations and their 
components are normally excluded from NEPA review, subject to a review 
for extraordinary circumstances. Actions taken by any successor 
organizations to those listed will also be categorically excluded. 
Actions taken by organizations of NIH not listed in this

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category may be included in other categories of excluded actions.
    1. Center for Information Technology.
    2. Center for Scientific Review.
    3. Fogarty International Center.
    4. Office of Administration.
    5. Office of Communications.
    6. Office of Equal Opportunity.
    7. Office of Education.
    8. Office of Community Liaison.
    9. Office of Loan Repayment and Scholarship.
    10. Office of Human Resources Management.
    11. Office of Financial Management.
    12. Office of Technology Transfer.
    13. Office of Program Coordination.
    14. National Library of Medicine.

D. Extraordinary Circumstances

    Consistent with CEQ's regulations, environmental review is required 
for all NIH actions involving extraordinary circumstances. Following 
are examples of extraordinary circumstances that may apply to specific 
NIH actions.
    1. Greater scope or size than other actions included within a 
category.
    2. A threatened violation of a Federal, State, or local law 
established for protection of the environment or for public health and 
safety.
    3. Potential effects of the action are unique or highly uncertain.
    4. Potential effect on a protected or ecologically sensitive area 
of land, like a wetland or floodplain.
    5. Possible impact on property that is listed or eligible for 
listing on the National Register of Historic Places or that is 
otherwise of scientific, cultural, or historic importance or interest.
    6. Possible impact on endangered or threatened species.
    7. Use of especially hazardous substances or processes for which 
adequate and accepted controls and safeguards are unknown or not 
available.
    8. Substantial and reasonable controversy exists about the 
environment effects of the action.

    Dated: January 10, 2000.
Ruth L. Kirschstein,
Acting Director, National Institutes of Health.
[FR Doc. 00-1128 Filed 1-18-00; 8:45 am]
BILLING CODE 4140-01-M