RECOMBINANT DNA ADVISORY COMMITTEE CHARTER

PURPOSE

In accordance with Section 301 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 241), the Secretary of Health and Human Services (Secretary) is directed to conduct and support research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control and prevention of physical and mental diseases and impairments of humans. In carrying out this mandate, exploration of the genetics of microbial agents and of animal cells by use of recombinant DNA (deoxyribonucleic acid) technology has shown tremendous promise for uncovering basic aspects of health and disease, and is appropriate for support by the National Institutes of Health (NIH). However, the use of this technology raises hypothetical hazards to public health and the environment and significant ethical, legal, and societal issues. The goal of the Recombinant DNA Advisory Committee (Committee) is to consider the current state of knowledge and technology regarding DNA recombinants, their survival in nature, and their transferability to other organisms, and their societal impact. The Committee shall recommend guidelines for the safe and ethical conduct of recombinant DNA research. The Committee is a technical Committee, established to look at a specific biomedical area.

AUTHORITY

42 U.S.C. 282(b)(6), Section 402(b)(6) of the PHS Act, as amended. The Committee is governed by the provisions of The Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

FUNCTION

The Committee shall advise the Director, NIH, concerning the current state of knowledge and technology regarding DNA recombinants, and recommend guidelines to be followed by investigators working with recombinant DNA.

As noted in the NIH Guidelines for Research Involving Recombinant DNA Molecules (59 FR 34496, amended, 59 FR 40170, 60 FR 20726, 61 FR 1482, 61 FR 10004, 62 FR 4782, 53335, 56196, 59032, 63 FR 8052, 26018), the Director, NIH, must seek the advice of the Recombinant DNA Advisory Committee before taking the following actions: changing containment levels for types of experiments that are specified in the NIH Guidelines; assigning containment levels for types of experiments that are not explicitly considered in the NIH Guidelines; certifying new host-vector systems; promulgating and amending a list of classes of recombinant DNA molecules to be exempt from the NIH Guidelines; permitting experiments specified by Section III-A of the NIH Guidelines; adopting other changes in the NIH Guidelines; interpreting and determining containment levels upon request by the Office of Biotechnology Activities; revising the "Classification of Etiologic Agents" for the purposes of the NIH Guidelines.

The Committee may recommend special workshops for exploration of particular problems.

STRUCTURE

The Committee shall consist of 15 members, including the Chair, appointed by the Director, NIH, at least 8 of whom shall be selected from authorities knowledgeable in the fields of molecular genetics, molecular biology, recombinant DNA research, or in scientific fields other than molecular genetics, molecular biology or recombinant DNA research, and at least 4 of whom shall be persons knowledgeable in applicable law, ethics, standards of professional conduct and practice, public attitudes, the environment, public health, occupational health, or related fields.

In addition, there shall be non-voting representatives from each of the following Federal agencies:

• Department of Agriculture
• Department of Commerce
• Department of Defense
• Department of Health and Human Services
  • National Institutes of Health
  • Office of Public Health and Science
    • Office of Human Research Protections
  • Centers for Disease Control and Prevention
    • National Institute for Occupational Safety and Health
  • Food and Drug Administration
    • Center for Biologics Evaluation and Research
• Department of Energy
• Department of Interior
• Department of Justice
• Department of Labor
• Department of State
• Department of Transportation
• Environmental Protection Agency
• Executive Office of the President
• National Aeronautics and Space Administration
• National Science Foundation
• Nuclear Regulatory Commission
• U.S. Arms Control and Disarmament Agency
• Department of Veterans Affairs

Ad hoc subcommittees will be formed, as needed. Subcommittees shall be composed of Committee members and, as required, of ad hoc consultants with expertise in the particular areas addressed by each subcommittee. All subcommittees shall report to the parent Committee. All proposals referred to a subcommittee for formal review must be approved or disapproved by a majority of a quorum of the subcommittee members before being submitted to the parent Committee. If a proposal is deferred by a subcommittee for two successive meetings, the investigator may appeal this decision by application to the full Committee.

Members shall be invited to serve for overlapping terms of four years; terms of more than two years are contingent upon the renewal of the Committee by appropriate action prior to its expiration. A member may serve after the expiration of the member's term until a successor has been appointed.

Management and support services shall be provided by the Office of Biotechnology Activities, Office of the Director, NIH.

MEETINGS

Meetings shall be held approximately four times a year at the call of the Chair with the advance approval of a Government official who shall also approve the agenda. A Government official shall be present at all meetings.

Meetings shall be open to the public except as determined otherwise by the Secretary; notice of all meetings shall be given to the public.

Meetings shall be conducted, and records of the proceedings kept, as required by applicable laws and Departmental policies.

QUORUM

A quorum for the Committee and each of its subcommittees shall consist of a majority of the appointed members eligible to vote. The non-voting agency representatives shall not be counted in calculating the quorum. Of the voting members, any who are disqualified from participating in an action on a particular issue, e.g., because they have not signed the "Commitment to Protect Privileged Recombinant DNA Information," or because of a real or apparent conflict of interest, shall not be counted in calculating the quorum. All votes relating to any review or recommendation by the Committee and its subcommittees shall be open to the public unless the meeting has been closed to the public in accordance with 5 U.S.C. 552b(c).

COMPENSATION

Members shall be paid at the authorized rate (currently $200 per day) for time spent at meetings, plus per diem and travel expenses as authorized by Section 5703, Title 5 U.S.C., as amended, for persons in the Government service employed intermittently. Members who are officers or employees of the United States Government shall not receive compensation for service on the Committee.

ANNUAL COST ESTIMATE

Estimated annual cost for operating the Committee, including compensation and travel expenses for members but excluding staff support, is $295,280. The estimated annual staff-years of support is 0.8, at an estimated cost of $69,957.

REPORTS

In the event a portion of a meeting is closed to the public, a report shall be prepared which shall contain, as a minimum, a list of members and their business addresses, the Committee's functions, dates, and places of meetings, and a summary of the Committee's activities and recommendations made during the fiscal year. A copy of the report shall be provided to the Department Committee Management Officer.

TERMINATION DATE

Unless renewed by appropriate action prior to its expiration, the Charter for the Recombinant DNA Advisory Committee shall expire on June 30, 2003.

APPROVED: May 29, 2001

Ruth Kirschstein
Acting Director, NIH