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21 U.S.C. § 360kk — Performance standards for electronic products

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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Source file: Laws/federal/codes/united-states-code/title-21/section-360kk-performance-standards-for-electronic-products--6ee40cf6d4.md
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Source location: Title 21, Chapter 9, § 360kk; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360hh&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section2112&num=0&edition=prelim). (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section1254&num=0&edition=prelim). (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section210&num=0&edition=prelim) 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.

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

42 U.S.C. § 210 — Appointment of osteopaths as commissioned officers

Graduates of colleges of osteopathy whose graduates are eligible for licensure to practice medicine or osteopathy in a majority of the States of the United States, or approved by a body or bodies acceptable to the Secretary, shall be eligible, subject to the other provisions of this Act, for appointment as commissioned medical officers in the Public Health Service.

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28 U.S.C. § 1254 — Courts of appeals; certiorari; certified questions

Cases in the courts of appeals may be reviewed by the Supreme Court by the following methods: (1) By writ of certiorari granted upon the petition of any party to any civil or criminal case, before or after rendition of judgment or decree; (2) By certification at any time by a court of appeals of any question of law in any civil or criminal case as to which instructions are desired, and upon such certification the Supreme Court may give binding instructions or require the entire record to be sent up for decision of the entire matter in controversy.

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28 U.S.C. § 2112 — Record on review and enforcement of agency orders

**(a)** The rules prescribed under the authority of [section 2072 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section2072&num=0&edition=prelim) may provide for the time and manner of filing and the contents of the record in all proceedings instituted in the courts of appeals to enjoin, set aside, suspend, modify, or otherwise review or enforce orders of administrative agencies, boards, commissions, and officers. Such rules may authorize the agency, board, commission, or officer to file in the court a certified list of the materials comprising the record and retain and hold for the court all such materials and transmit the same or any part thereof to the court, when and as required by it, at any time prior to the final determination of the proceeding, and such filing of such certified list of the materials comprising the record and such subsequent transmittal of any such materials when and as required shall be deemed full compliance with any provision of law requiring the filing of the record in the court. The record in such proceedings shall be certified and filed in or held for and transmitted to the court of appeals by the agency, board, commission, or officer concerned within the time and in the manner prescribed by such rules. If proceedings are instituted in two or more courts of appeals with respect to the same order, the following shall apply: (1) If within ten days after issuance of the order the agency, board, commission, or officer concerned receives, from the persons instituting the proceedings, the petition for review with respect to proceedings in at least two courts of appeals, the agency, board, commission, or officer shall proceed in accordance with paragraph (3) of this subsection. If within ten days after the is

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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. § 360ii — Program of control

**(a) Establishment** The Secretary shall establish and carry out an electronic product radiation control program designed to protect the public health and safety from electronic product radiation. As a part of such program, he shall— (1) pursuant to [section 360kk of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim), develop and administer performance standards for electronic products; (2) plan, conduct, coordinate, and support research, development, training, and operational activities to minimize the emissions of and the exposure of people to, unnecessary electronic product radiation; (3) maintain liaison with and receive information from other Federal and State departments and agencies with related interests, professional organizations, industry, industry and labor associations, and other organizations on present and future potential electronic product radiation; (4) study and evaluate emissions of, and conditions of exposure to, electronic product radiation and intense magnetic fields; (5) develop, test, and evaluate the effectiveness of procedures and techniques for minimizing exposure to electronic product radiation; and (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim) to control such radiation emissions. **(b) Powers of Secretary** In carrying out the p

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21 U.S.C. § 360ll — Notification of defects in and repair or replacement of electronic products

**(a) Notification; exemption** (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim) 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. (2) If, in the opinion of such manufacturer, the defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he may, at the time of giving notice to the Secretary of such defect or failure to comply, apply to the Secretary for an exemption from the requirement of notice to the persons specified in subsection (b). If such application states reasonable grounds for such exemption, the Secretary shall afford such manufacturer an opportunity to present his views and evidence in support of the application, the burden of proof being on the manufacturer. If, after such presentation, the Secretary is satisfied that such defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he shall exempt such manufacturer from the req

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21 U.S.C. § 360mm — Imports

**(a) Refusal of admission to noncomplying electronic products** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk/h&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim), 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. **(b) Bond** 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 standa

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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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21 U.S.C. § 360pp — Enforcement

**(a) Jurisdiction of courts** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section1355&num=0&edition=prelim) to enforce the provisions of subsection (b) of this section. **(b) Penalties** (1) Any person who violates section 360oo of this title shall be subject to a civil penalty of not more than $1,000. For purposes of this subsection, any such violation shall with respect to each electronic product involved, or with respect to each act or omission made unlawful by section 360oo of this title, constitute a separate violation, except that the maximum civil penalty imposed on any person under this subsection for any related series of violations shall not exceed $300,000. (2) Any such civil penalty may on application be remitted or mitigated by the Secretary. In determining the amount of such penalty, or whether it should be remitted or mitigated and in what amount, the appropriateness of such penalty to the size of the business of the person charged and the gravity of the violation shall be considered. The amount of such penalty, when finally determined

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21 U.S.C. § 360ss — State standards

Whenever any 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) 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.

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