§360nn — Title 21 Food and Drugs | U.S. Code

Summary

Gives the Secretary the power to check factories and records when there is a real reason to doubt that product testing or safety programs are enough. Authorized inspectors, after showing ID and giving written notice, can enter areas where required tests are done and look at the testing places and procedures at reasonable times. Inspections must be started and finished without delay. If a manufacturer sells a product that does not follow a required safety standard and no exemption was allowed, that is one reason the Secretary can inspect. Manufacturers must keep and share records (including test results), reports, and safety data the Secretary asks for. They must let inspectors see books and documents that are needed to check compliance. The Secretary can also require makers to give safety and technical information to the first buyer at the time of purchase, after talking with the industry. Accident and investigation reports made by the Secretary’s staff can be used in court, and staff may have to testify about what they found. These reports are public but do not have to name people. Research and project reports are public, too. The Secretary must protect trade secrets and other confidential business information, but may share them with government workers who need them or when they are needed in legal proceedings, and must not withhold information from Congress’s authorized committees. By rule, the Secretary can require dealers and distributors to give manufacturers information needed to find first buyers of products with a retail price of $50 or more. Dealers can choose to hold that information until it is needed, must tell the manufacturer if they do, and must turn the information over if they stop selling the product. Manufacturers who get buyer information must keep it confidential and use it only to notify buyers as the law requires.

Title 21, §360nn

Food and Drugs — Source: USLM XML via OLRC

(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.

(b)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)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)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)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, 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)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.

Notes & Related Subsidiaries

Editorial Notes

Codification Section was classified to section 263i of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263i of Title 42, The Public Health and Welfare, as this section. 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), substituted “this part” for “this subpart” wherever appearing. Subsec. (f). Pub. L. 101–629, § 19(a)(1)(B), (2)(E)(ii), substituted “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 AgenciesEnactment of this section not to be construed to supersede or limit the functions under any other provision 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.

§360nn Inspection, records, and reports