00-1128. 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.

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 [phone], FAX [phone], E-mail Address: [e-mail].

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 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 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.