
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360kk]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
              Part C--Electronic Product Radiation Control
 
Sec. 360kk. Performance standards for electronic products


(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 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.

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

                          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, Sec. 4(a)(2), amended directory language of 
Pub. L. 101-629, Sec. 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, Sec. 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, Sec. 19(a)(2)(B), 
substituted ``section 360hh'' for ``section 263c''.
    Subsecs. (e), (f)(1)(A). Pub. L. 101-629, Sec. 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''.


               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.

                  Section Referred to in Other Sections

    This section is referred to in sections 360ii, 360ll, 360mm, 360nn, 
360oo, 360pp, 360ss of this title.
