§360kk. Performance standards for electronic products — Inbound Citations
21 U.S.C. § 360kk
Code of Federal Regulations Citations
Cited by 7 regulations in the Code of Federal Regulations.
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The importation of any electronic product for which standards have been prescribed under section 534 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360kk) shall be refused admission into the United States unless there is affixed to such product a certification in the form of a label or tag in conformity with section 534(h) of the act (21 U.S.C. 360kk(h)). Merchandise refused admission shall be destroyed or exported under regulations prescribed by the Secretary of the Treasury unless a timely and adequate petition for permission to bring the product into compliance is filed and granted under §§ 1005.21 and 1005.22.
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The standards listed in this subchapter are prescribed pursuant to section 534 of Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 360kk) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety.
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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.
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(2) Provides consultation to the Commissioner on all performance standards proposed for consideration under 21 U.S.C. 360kk; and
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(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.
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(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.
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(c) TEPRSSC is a permanent statutory advisory committee established by section 358(f)(1)(A) of the Public Health Service Act, as added by the Radiation Control for Health and Safety Act of 1968, transferred to the FD&C Act (21 U.S.C. 360kk(f)(1)(A)), and is not subject to termination and renewal under paragraph (a) of this section, except that a new charter is prepared and filed at the end of each 2-year period as provided in § 14.40(c). Also, the statutory medical device classification panels established under section 513(b)(1) of the FD&C Act (21 U.S.C. 360c(b)(1)) and part 860, and the statutory medical device good manufacturing practice advisory committees established under section 520(f)(3) of the FD&C Act (21 U.S.C. 360j(f)(3)), are specifically exempted from the normal 2-year duration period.
United States Code Citations
Cited by 13 provisions in release 119-102.
Citations to 21 U.S.C. § 360kk as a whole
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(1) pursuant to section 360kk of this title, develop and administer performance standards for electronic products;
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(6) consult and maintain liaison with the Secretary of Commerce, the Secretary of Defense, the Secretary of Labor, the Atomic Energy Commission, and other appropriate Federal departments and agencies on (A) techniques, equipment, and programs for testing and evaluating electronic product radiation, and (B) the development of performance standards pursuant to section 360kk of this title to control such radiation emissions.
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(1) Every manufacturer of electronic products who discovers that an electronic product produced, assembled, or imported by him has a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, or that an electronic product produced, assembled, or imported by him on or after the effective date of an applicable standard prescribed pursuant to section 360kk of this title fails to comply with such standard, shall immediately notify the Secretary of such defect or failure to comply if such product has left the place of manufacture and shall (except as authorized by paragraph (2)) with reasonable promptness furnish notification of such defect or failure to the persons (where known to the manufacturer) specified in subsection (b) of this section.
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(e) If through testing, inspection, investigation, or research carried out pursuant to this part, or examination of reports submitted pursuant to section 360nn of this title, or otherwise, the Secretary determines that any electronic product—(1) does not comply with an applicable standard prescribed pursuant to section 360kk of this title; or(2) contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation;he shall immediately notify the manufacturer of such product of such defect or failure to comply. The notice shall contain the findings of the Secretary and shall include all information upon which the findings are based. The Secretary shall afford such manufacturer an opportunity to present his views and evidence in support thereof, to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the product by reason of the emission of such radiation hazard. If after such presentation by the manufacturer the Secretary determines that such product does not comply with an applicable standard prescribed pursuant to section 360kk of this title, or that it contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, the Secretary shall direct the manufacturer to furnish the notification specified in subsection (c) of this section to the persons specified in paragraphs (1) and (2) of subsection (b) of this section (where known to the manufacturer), unless the manufacturer has applied for an exemption from the requirement of such notification on the ground specified in paragraph (2) of subsection (a) and the Secretary is satisfied that such noncompliance or defect is not such as to create a significant risk of injury, including genetic injury, to any person.
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(1) does not comply with an applicable standard prescribed pursuant to section 360kk of this title; or
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(a) Any electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed under this part, or to which is not affixed a certification in the form of a label or tag in conformity with section 360kk(h) of this title shall be refused admission into the United States. The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon the latter’s request, samples of electronic products which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may have a hearing before the Secretary of Health and Human Services. If it appears from an examination of such samples or otherwise that any electronic product fails to comply with applicable standards prescribed pursuant to section 360kk of this title, then, unless subsection (b) of this section applies and is complied with, (1) such electronic product shall be refused admission, and (2) the Secretary of the Treasury shall cause the destruction of such electronic product unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days after the date of notice of refusal of admission or within such additional time as may be permitted by such regulations.
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(b) If it appears to the Secretary of Health and Human Services that any electronic product refused admission pursuant to subsection (a) of this section can be brought into compliance with applicable standards prescribed pursuant to section 360kk of this title, final determination as to admission of such electronic product may be deferred upon filing of timely written application by the owner or consignee and the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as the Secretary of Health and Human Services may by regulation prescribe. If such application is filed and such bond is executed the Secretary of Health and Human Services may, in accordance with rules prescribed by him, permit the applicant to perform such operations with respect to such electronic product as may be specified in the notice of permission.
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(1) for any manufacturer to introduce, or to deliver for introduction, into commerce, or to import into the United States, any electronic product which does not comply with an applicable standard prescribed pursuant to section 360kk of this title;
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(a) The district courts of the United States shall have jurisdiction, for cause shown, to restrain violations of section 360oo of this title and to restrain dealers and distributors of electronic products from selling or otherwise disposing of electronic products which do not conform to an applicable standard prescribed pursuant to section 360kk of this title except when such products are disposed of by returning them to the distributor or manufacturer from whom they were obtained. The district courts of the United States shall also have jurisdiction in accordance with section 1355 of title 28 to enforce the provisions of subsection (b) of this section.
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Whenever any standard prescribed pursuant to section 360kk of this title with respect to an aspect of performance of an electronic product is in effect, no State or political subdivision of a State shall have any authority either to establish, or to continue in effect, any standard which is applicable to the same aspect of performance of such product and which is not identical to the Federal standard. Nothing in this part shall be construed to prevent the Federal Government or the government of any State or political subdivision thereof from establishing a requirement with respect to emission of radiation from electronic products procured for its own use if such requirement imposes a more restrictive standard than that required to comply with the otherwise applicable Federal standard.
Citations to §360kk(h)
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(a) Any electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed under this part, or to which is not affixed a certification in the form of a label or tag in conformity with section 360kk(h) of this title shall be refused admission into the United States. The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon the latter’s request, samples of electronic products which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may have a hearing before the Secretary of Health and Human Services. If it appears from an examination of such samples or otherwise that any electronic product fails to comply with applicable standards prescribed pursuant to section 360kk of this title, then, unless subsection (b) of this section applies and is complied with, (1) such electronic product shall be refused admission, and (2) the Secretary of the Treasury shall cause the destruction of such electronic product unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days after the date of notice of refusal of admission or within such additional time as may be permitted by such regulations.
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(a) If the Secretary finds for good cause that the methods, tests, or programs related to electronic product radiation safety in a particular factory, warehouse, or establishment in which electronic products are manufactured or held, may not be adequate or reliable, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are thereafter authorized (1) to enter, at reasonable times, any area in such factory, warehouse, or establishment in which the manufacturer’s tests (or testing programs) required by section 360kk(h) of this title are carried out, and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, the facilities and procedures within such area which are related to electronic product radiation safety. Each such inspection shall be commenced and completed with reasonable promptness. In addition to other grounds upon which good cause may be found for purposes of this subsection, good cause will be considered to exist in any case where the manufacturer has introduced into commerce any electronic product which does not comply with an applicable standard prescribed under this part and with respect to which no exemption from the notification requirements has been granted by the Secretary under section 360ll(a)(2) or 360ll(e) of this title.
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(5) for any person (A) to fail to issue a certification as required by section 360kk(h) of this title, or (B) to issue such a certification when such certification is not based upon a test or testing program meeting the requirements of section 360kk(h) of this title or when the issuer, in the exercise of due care, would have reason to know that such certification is false or misleading in a material respect.