CFR Subpart G

CFR Subpart G
in effect

21 C.F.R. § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

The Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC), consisting of 15 members, is established in accordance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360kk(f)(1)(A)) to provide consultation before the Commissioner prescribes any performance standard for an electronic product.

21 C.F.R. § 14.122 Functions of TEPRSSC.

(a) In performing its function of advising the Commissioner, TEPRSSC— (1) May propose electronic product radiation safety standards to the Commissioner for consideration; (2) Provides consultation to the Commissioner on all performance standards proposed for consideration under 21 U.S.C. 360kk; and (3) May make recommendations to the Commissioner on any other matters it deems necessary or appropriate in fulfilling the purposes of the act. (b) Responsibility for action on performance standards under 21 U.S.C. 360kk rests with the Commissioner, after receiving the advice of TEPRSSC.

21 C.F.R. § 14.125 Procedures of TEPRSSC.

(a) When the Commissioner is considering promulgation of a performance standard for an electronic product, or an amendment of an existing standard, before issuing a proposed regulation in the Federal Register the Commissioner will submit to TEPRSSC the proposed standard or amendment under consideration, together with other relevant information to aid TEPRSSC in its deliberations. (b) The agenda and other material to be considered at any meeting will be sent to members whenever possible at least 2 weeks before the meeting. (c) Ten members constitute a quorum, provided at least three members are present from each group specified in 21 U.S.C. 360kk(f)(1)(A) and in § 14.127(a), i.e., Government, industry, and the public. (d) The Chairperson of TEPRSSC will ordinarily submit a report to the Commissioner of the committee's consideration of any proposed performance standard for an electronic product within 60 days after consideration. If the Chairperson believes that more time is needed, the Chairperson will inform the Director of the Center for Devices and Radiological Health in writing, in which case an additional 30 days will be allowed to make the report. (e) Sections 14.1 through 14.7 apply to TEPRSSC, except where other provisions are specifically included in §§ 14.120 through 14.130.

21 C.F.R. § 14.127 Membership of TEPRSSC.

(a) The Commissioner will appoint the members after consultation with public and private organizations concerned with the technical aspect of electronic product radiation safety. TEPRSSC consists of 15 members, each of whom is technically qualified by training and experienced in one or more fields of science or engineering applicable to electronic product radiation safety, as follows: (1) Five members selected from government agencies, including State and Federal Governments. (2) Five members selected from the affected industries after consultation with industry representatives. (3) Five members selected from the general public, of whom at least one shall be a representative of organized labor. (b) The Commissioner will appoint a committee member as Chairperson of TEPRSSC. (c) Appointments of members are for a term of 3 years or as specified by the Commissioner. (1) The Chairperson is appointed for a term concurrent with the Chairperson's term as a member of TEPRSSC. If the Chairpersonship becomes vacant without adequate notice, the Designated Federal Officer may appoint a committee member as temporary Chairperson pending appointment of a new Chairperson by the Commissioner. (2) Members may not be reappointed for a second consecutive full term. (d) A person otherwise qualified for membership is not eligible for selection as a member of TEPRSSC from Government agencies or the general public if the Commissioner determines that the person does not meet the requirements of the conflict of interest laws and regulations. (e) Retention of membership is conditioned upon the following: (1) Continued status as a member of the group from which the member was selected as specified in paragraph (a) of this section. (2) Absence of any conflict of interest during the term of membership as specified in paragraph (d) of this section. (3) Active participation in TEPRSSC activities. (f) Appointment as a member of TEPRSSC is conditioned on certification that the prospective member: (1) Agrees to the procedures and criteria specified in this subpart. (2) Has no conflict of interest as specified in paragraph (d) of this section. (3) Will notify the Designated Federal Officer of TEPRSSC before any change in representative status on TEPRSSC which may be contrary to the conditions of the appointment. (g) Members of TEPRSSC who are not full-time officers or employees of the United States receive compensation under § 14.95, in accordance with 42 U.S.C. 210(c).

21 C.F.R. § 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records.

(a) In accordance with 21 U.S.C. 360kk(f)(1)(B), all proceedings of TEPRSSC are recorded, and the record of each proceeding is available for public inspection. (b) All proceedings of TEPRSSC are open except when the Commissioner has determined, under § 14.27, that a portion of a meeting may be closed.

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