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21 U.S.C. § 360hh — Definitions
Federal law — U.S. Code and appendices · legal_authorities
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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360hh
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Stable record: federal_law:legal_authorities:record_usc_c6ebf69bb1873d46d974c339
Source file: Laws/federal/codes/united-states-code/title-21/section-360hh-definitions--6f0b4ef2b8.md
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Source location: Title 21, Chapter 9, § 360hh; chapter-009-federal-food-drug-and-cosmetic-act.md
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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
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** As used in this section:
(1) **Accreditation body** — The term “accreditation body” means a body that has been approved by the Secretary under subsection (e)(1)(A) to accredit mammography facilities.
(2) **Certificate** — The term “certificate” means the certificate described in subsection (b)(1).
(3) **Facility**
(A) *In general* — The term “facility” means a hospital, outpatient department, clinic, radiology practice, or mobile unit, an office of a physician, or other facility as determined by the Secretary, that conducts breast cancer screening or diagnosis through mammography activities. Such term does not include a facility of the Department of Veterans Affairs.
(B) *Activities* — For the purposes of this section, the activities of a facility include the operation of equipment to produce the mammogram, the processing of the film, the initial interpretation of the mammogram and the viewing conditions for that interpretation. Where procedures such as the film processing, or the interpretation of the mammogram are performed in a location different from where the mammogram is performed, the facility performing the mammogram shall be responsible for meeting the quality standards described in subsection (f).
(4) **Inspection** — The term “inspection” means an onsite evaluation of the facility by the Secretary, or State or local agency on behalf of the Secretary.
(5) **Mammogram** — The term “mammogram” means a radiographic image produced through mammography.
(6) **Mammography** — The term “mammography” means radiography of the breast.
(7) **Survey** — The term “survey” means an onsite physics consultation and evaluation performed by a medical physicist as described in subsection (f)(1)(E).
(8) **Review physician** — The term “review phys
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 263b
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Authority to regulate** The Commission shall have no authority under this chapter to regulate any risk of injury associated with a consumer product if such risk could be eliminated or reduced to a sufficient extent by actions taken under the Occupational Safety and Health Act of 1970 [[29 U.S.C. 651](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section651&num=0&edition=prelim) et seq.]; the Atomic Energy Act of 1954 [[42 U.S.C. 2011](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section2011&num=0&edition=prelim) et seq.]; or the Clean Air Act [[42 U.S.C. 7401](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section7401&num=0&edition=prelim) et seq.]. The Commission shall have no authority under this chapter to regulate any risk of injury associated with electronic product radiation emitted from an electronic product (as such terms are defined by sections 355(1) and (2) 11 See References in Text note below. of the Public Health Service Act) if such risk of injury may be subjected to regulation under subpart 3 1 of part F of title III of the Public Health Service Act.
**(b) Certain notices of proposed rulemaking; duties of Chronic Hazard Advisory Panel**
(1) The Commission may not issue—
(A) an advance notice of proposed rulemaking for a consumer product safety rule,
(B) a notice of proposed rulemaking for a rule under [section 2076(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section2076/e&num=0&edition=prelim), or
(C) an advance notice of proposed rulemaking for regulations under [section 1261(q)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1261/q/1&num=0&edition=prelim),
relating to a risk of c
Source: Supplied U.S. Code snapshot — release unconfirmed · 15 U.S.C. § 2080
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360ii
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Report to Congress** The Secretary shall conduct the following studies, and shall make a report or reports of the results of such studies to the Congress on or before January 1, 1970, and from time to time thereafter as he may find necessary, together with such recommendations for legislation as he may deem appropriate:
(1) A study of present State and Federal control of health hazards from electronic product radiation and other types of ionizing radiation, which study shall include, but not be limited to—
(A) control of health hazards from radioactive materials other than materials regulated under the Atomic Energy Act of 1954 [[42 U.S.C. 2011](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section2011&num=0&edition=prelim) et seq.];
(B) any gaps and inconsistencies in present controls;
(C) the need for controlling the sale of certain used electronic products, particularly antiquated X-ray equipment, without upgrading such products to meet the standards for new products or separate standards for used products;
(D) measures to assure consistent and effective control of the aforementioned health hazards;
(E) measures to strengthen radiological health programs of State governments; and
(F) the feasibility of authorizing the Secretary to enter into arrangements with individual States or groups of States to define their respective functions and responsibilities for the control of electronic product radiation and other ionizing radiation;
(2) A study to determine the necessity for the development of standards for the use of nonmedical electronic products for commercial and industrial purposes; and
(3) A study of the development of practicable procedures for the detection and measurement of electronic product radiation which ma
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360jj
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360kk
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360ll
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360mm
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360nn
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360oo
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