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

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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Stable record: federal_law:legal_authorities:record_usc_c2d610a7489ac84faef091f8
Source file: Laws/federal/codes/united-states-code/title-21/section-360nn-inspection-records-and-reports--42aec7d71a.md
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Source location: Title 21, Chapter 9, § 360nn; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(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 such manufacturer has acted or is acting in compliance with this part and standards prescribed pursuant to this part and shall, upon request of an officer or employee duly designated by the Secretary, permit such officer or employee to inspect appropriate books, papers, records, and documents relevant to determining whether such manufacturer has acted or is acting in compliance with standards prescribed pursuant to this part. **(c) Disclosure of technical data** Every manufacturer of electronic products shall provide to the Secretary such performance data and other technical data related to safety as may be required to carry out the purposes of this part. The Secretary is authorized to require the manufacturer to give such notification of such performance and technical data at the time of original purchase to the ultimate purchaser of the electronic product, as he determines necessary to carry out the purposes of this part after consulting with the affected industry. **(d) Public nature of reports** Accident and investigation reports made under this part by any officer, employee, or agent of the Secretary shall be available for use in any civil, criminal, or other judicial proceeding arising out of such accident. Any such officer, employee, or agent may be required to testify in such proceedings as to the facts developed in such investigations. Any such report shall be made available to the public in a manner which need not identify individuals. All reports on research projects, demonstration projects, and other related activities shall be public information. **(e) Trade secrets** The Secretary or his representative shall not disclose any information reported to or otherwise obtained by him, pursuant to subsection (a) or (b) of this section, which concerns any information which contains or relates to a trade secret or other matter referred to in [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim), except that such information may be disclosed to other officers or employees of the Department and of other agencies concerned with carrying out this part or when relevant in any proceeding under this part. Nothing in this section shall authorize the withholding of information by the Secretary, or by any officers or employees under his control, from the duly authorized committees of the Congress. **(f) Information required to identify and locate first purchasers of electronic products** The Secretary may by regulation (1) require dealers and distributors of electronic products, to which there are applicable standards prescribed under this part and the retail prices of which is not less than $50, to furnish manufacturers of such products such information as may be necessary to identify and locate, for purposes of section 360ll of this title, the first purchasers of such products for purposes other than resale, and (2) require manufacturers to preserve such information. Any regulation establishing a requirement pursuant to clause (1) of the preceding sentence shall (A) authorize such dealers and distributors to elect, in lieu of immediately furnishing such information to the manufacturer, to hold and preserve such information until advised by the manufacturer or Secretary that such information is needed by the manufacturer for purposes of section 360ll of this title, and (B) provide that the dealer or distributor shall, upon making such election, give prompt notice of such election (together with information identifying the notifier and the product) to the manufacturer and shall, when advised by the manufacturer or Secretary, of the need therefor for the purposes of section 360ll of this title, immediately furnish the manufacturer with the required information. If a dealer or distributor discontinues the dealing in or distribution of electronic products, he shall turn the information over to the manufacturer. Any manufacturer receiving information pursuant to this subsection concerning first purchasers of products for purposes other than resale shall treat it as confidential and may use it only if necessary for the purpose of notifying persons pursuant to section 360ll(a) of this title.

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

18 U.S.C. § 1905 — Disclosure of confidential information generally

Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.

Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905

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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.

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360hh

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

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

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

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

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360oo

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

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

Page 410 TITLE 21—FOOD AND DRUGS § 360mm § 360mm. Imports (a) Refusal of admission to noncomplying elec- tronic 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 certifi- cation in the form of a label or tag in con- formity 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 prod- ucts which are being imported or offered for im- port into the United States, giving notice there- of to the owner or consignee, who may have a hearing before the Secretary of Health and Human Services. If it appears from an examina- tion of such samples or otherwise that any elec- tronic 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 un- less 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 re- fused 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 produ

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 360nn

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