§360kk. Performance standards for electronic products

21 U.S.C. § §360kk. Performance standards for electr

• Title: 21 — Food and Drugs
• Chapter: SUBCHAPTER V—DRUGS AND DEVICES
• Part: C

Text

(a) Promulgation of regulations
(1) The Secretary shall by regulation prescribe performance standards for electronic products to control the emission of electronic product radiation from such products if he determines that such standards are necessary for the protection of the public health and safety. Such standards may include provisions for the testing of such products and the measurement of their electronic product radiation emissions, may require the attachment of warning signs and labels, and may require the provision of instructions for the installation, operation, and use of such products. Such standards may be prescribed from time to time whenever such determinations are made, but the first of such standards shall be prescribed prior to January 1, 1970. In the development of such standards, the Secretary shall consult with Federal and State departments and agencies having related responsibilities or interests and with appropriate professional organizations and interested persons, including representatives of industries and labor organizations which would be affected by such standards, and shall give consideration to—
(A) the latest available scientific and medical data in the field of electronic product radiation;
(B) the standards currently recommended by (i) other Federal agencies having responsibilities relating to the control and measurement of electronic product radiation, and (ii) public or private groups having an expertise in the field of electronic product radiation;
(C) the reasonableness and technical feasibility of such standards as applied to a particular electronic product;
(D) the adaptability of such standards to the need for uniformity and reliability of testing and measuring procedures and equipment; and
(E) in the case of a component, or accessory described in paragraph (2)(B) of section 360hh of this title, the performance of such article in the manufactured or assembled product for which it is designed.
(2) The Secretary may prescribe different and individual performance standards, to the extent appropriate and feasible, for different electronic products so as to recognize their different operating characteristics and uses.
(3) The performance standards prescribed under this section shall not apply to any electronic product which is intended solely for export if (A) such product and the outside of any shipping container used in the export of such product are labeled or tagged to show that such product is intended for export, and (B) such product meets all the applicable requirements of the country to which such product is intended for export.
(4) The Secretary may by regulation amend or revoke any performance standard prescribed under this section.
(5) The Secretary may exempt from the provisions of this section any electronic product intended for use by departments or agencies of the United States provided such department or agency has prescribed procurement specifications governing emissions of electronic product radiation and provided further that such product is of a type used solely or predominantly by departments or agencies of the United States.
(b) Administrative procedure
The provisions of subchapter II of chapter 5 of title 5 (relating to the administrative procedure for rulemaking), and of chapter 7 of title 5 (relating to judicial review), shall apply with respect to any regulation prescribing, amending, or revoking any standard prescribed under this section.
(c) Publication in Federal Register
Each regulation prescribing, amending, or revoking a standard shall specify the date on which it shall take effect which, in the case of any regulation prescribing, or amending any standard, may not be sooner than one year or not later than two years after the date on which such regulation is issued, unless the Secretary finds, for good cause shown, that an earlier or later effective date is in the public interest and publishes in the Federal Register his reason for such finding, in which case such earlier or later date shall apply.
(d) Judicial review
(1) In a case of actual controversy as to the validity of any regulation issued under this section prescribing, amending, or revoking a performance standard, any person who will be adversely affected by such regulation when it is effective may at any time prior to the sixtieth day after such regulation is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such regulation. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based the regulation, as provided in section 2112 of title 28.
(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendations, if any, for the modification or setting aside of his original regulation, with the return of such additional evidence.
(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to review the regulation in accordance with chapter 7 of title 5 and to grant appropriate relief as provided in such chapter.
(4) The judgment of the court affirming or setting aside, in whole or in part, any such regulation of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28.
(5) Any action instituted under this subsection shall survive, notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.
(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.
(e) Availability of record
A certified copy of the transcript of the record and administrative proceedings under this section shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, exclusion of imports, or other proceeding arising under or in respect of this part irrespective of whether proceedings with respect to the regulation have previously been initiated or become final under this section.
(f) Technical Electronic Product Radiation Safety Standards Committee
(1)(A) The Secretary shall establish a Technical Electronic Product Radiation Safety Standards Committee (hereafter in this part referred to as the "Committee") which he shall consult before prescribing any standard under this section. The Committee shall be appointed by the Secretary, after consultation with public and private agencies concerned with the technical aspect of electronic product radiation safety, and shall be composed of fifteen members each of whom shall be technically qualified by training and experience in one or more fields of science or engineering applicable to electronic product radiation safety, as follows:
(i) Five members shall be selected from governmental agencies, including State and Federal Governments;
(ii) Five members shall be selected from the affected industries after consultation with industry representatives; and
(iii) Five members shall be selected from the general public, of which at least one shall be a representative of organized labor.
(B) The Committee may propose electronic product radiation safety standards to the Secretary for his consideration. All proceedings of the Committee shall be recorded and the record of each such proceeding shall be available for public inspection.
(2) Payments to members of the Committee who are not officers or employees of the United States pursuant to subsection (c) of section 210 of title 42 shall not render members of the Committee officers or employees of the United States for any purpose.
(g) Review and evaluation
The Secretary shall review and evaluate on a continuing basis testing programs carried out by industry to assure the adequacy of safeguards against hazardous electronic product radiation and to assure that electronic products comply with standards prescribed under this section.
(h) Product certification
Every manufacturer of an electronic product to which is applicable a standard in effect under this section shall furnish to the distributor or dealer at the time of delivery of such product, in the form of a label or tag permanently affixed to such product or in such manner as approved by the Secretary, the certification that such product conforms to all applicable standards under this section. Such certification shall be based upon a test, in accordance with such standard, of the individual article to which it is attached or upon a testing program which is in accord with good manufacturing practice and which has not been disapproved by the Secretary (in such manner as he shall prescribe by regulation) on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this section.

History

(June 25, 1938, ch. 675, §534, formerly act July 1, 1944, ch. 373, title III, §534, formerly §358, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1177; amended Pub. L. 91–515, title VI, §601(b)(2), (3), Oct. 30, 1970, 84 Stat. 1311; renumbered §534 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §§3(w), 4(a)(2), Aug. 13, 1993, 107 Stat. 778, 779.)

Editorial Notes

Editorial Notes

Codification
Section was classified to section 263f of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments
1993—Pub. L. 103–80, §4(a)(2), amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263f of Title 42, The Public Health and Welfare, as this section.
Subsec. (f)(2). Pub. L. 103–80, §3(w), made technical amendment to reference to section 210 of title 42 to reflect correction of corresponding provision of original act.
1990—Subsec. (a)(1)(E). Pub. L. 101–629, §19(a)(2)(B), substituted "section 360hh" for "section 263c".
Subsecs. (e), (f)(1)(A). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".
1970—Subsec. (f)(2). Pub. L. 91–515 struck out provisions related to payment of compensation and travel expenses of members of the Committee who are not officers or employees of the United States, and substituted "to members of the Committee who are not officers or employees of the United States pursuant to subsection (c) of section 210 of title 42" for "under this subsection".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies
Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.