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21 U.S.C. § 360oo — Prohibited acts

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360oo — Prohibited acts

**(a)** It shall be unlawful— (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim); (2) for any person to fail to furnish any notification or other material or information required by section 360ll or 360nn of this title; or to fail to comply with the requirements of section 360ll(f) of this title; (3) for any person to fail or to refuse to establish or maintain records required by this part or to permit access by the Secretary or any of his duly authorized representatives to, or the copying of, such records, or to permit entry or inspection, as required by or pursuant to [section 360nn of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360nn&num=0&edition=prelim); (4) for any person to fail or to refuse to make any report required pursuant to [section 360nn(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360nn/b&num=0&edition=prelim) or to furnish or preserve any information required pursuant to [section 360nn(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360nn/f&num=0&edition=prelim); or (5) for any person (A) to fail to issue a certification as required by [section 360kk(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk/h&num=0&edition=prelim), or (B) to issue such a certification when such certification is not based upon a test or testing program meeting the requirements of [section 360

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Source location: Title 21, Chapter 9, § 360oo; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 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

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360nn — Inspection, records, and reports

**(a) Inspection of premises** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk/h&num=0&edition=prelim) 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. **(b) Record keeping** Every manufacturer of electronic products shall establish and maintain such records (including testing records), make such reports, and provide such information, as the Secretary may reasonably require to enable him to determine whether

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360hh — Definitions

As used in this part— (1) the term “electronic product radiation” means— (A) any ionizing or non-ionizing electromagnetic or particulate radiation, or (B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product; (2) the term “electronic product” means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation; (3) the term “manufacturer” means any person engaged in the business of manufacturing, assembling, or importing of electronic products; (4) the term “commerce” means (A) commerce between any place in any State and any place outside thereof; and (B) commerce wholly within the District of Columbia; and (5) the term “State” includes the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, and American Samoa.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360oo — Prohibited acts

Page 412 TITLE 21—FOOD AND DRUGS § 360oo of Title 42, The Public Health and Welfare, as this sec- tion. 1990—Subsec. (a). Pub. L. 101–629, § 19(a)(1)(B), (2)(E), substituted ‘‘section 360kk(h)’’ for ‘‘section 263f(h)’’, ‘‘this part’’ for ‘‘this subpart’’, and ‘‘section 360ll(a)(2) or 360ll(e)’’ for ‘‘section 263g(a)(2) or 263g(e)’’. Subsecs. (b) to (e). Pub. L. 101–629, § 19(a)(1)(B), sub- stituted ‘‘this part’’ for ‘‘this subpart’’ wherever ap- pearing. Subsec. (f). Pub. L. 101–629, § 19(a)(1)(B), (2)(E)(ii), sub- stituted ‘‘this part’’ for ‘‘this subpart’’, ‘‘section 360ll’’ for ‘‘section 263g’’ in three places, and ‘‘section 360ll(a)’’ for ‘‘section 263g(a)’’. Statutory Notes and Related Subsidiaries NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment of this section not to be construed to su- persede or limit the functions under any other provi- sion 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. § 360oo. Prohibited acts (a) It shall be unlawful— (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 appli- cable standard prescribed pursuant to section 360kk of this title; (2) for any person to fail to furnish any noti- fication or other material or information re- quired by section 360ll or 360nn of this title; or to fail to comply with the requirements of sec- tion 360ll(f) of this title; (3) for any person to fail or to refuse to es- tablish or maintain records required by this part or to permit access by the Secretary or any of his duly authorized representatives to, or the copying of, such records, or to permit entry or ins

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