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

Summary

Imported electronic products that do not meet required safety standards or do not have the proper certification label must be turned away and not allowed into the United States. If the Department of Health and Human Services (HHS) asks, the Treasury must give HHS samples of the imported items and must tell the owner or consignee, who can request a hearing. If HHS finds the items fail to meet standards, they will be refused entry and the Treasury will destroy them unless they are exported within 90 days (or within more time if rules allow). If HHS thinks the product can be fixed to meet the rules, the owner can file a timely written request and post a bond. HHS may then allow work to be done under its rules. All costs for destruction, supervision, storage, transport, and labor must be paid by the owner or consignee; if they fail to pay, a lien can be placed on their future imports. Manufacturers must name and file a written agent in the U.S. to receive official notices; if they do not, notices may be posted in the HHS office.

Title 21, §360mm

Food and Drugs — Source: USLM XML via OLRC

(a)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 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, 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)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 standards prescribed pursuant to section 360kk of this title, final determination as to admission of such electronic product may be deferred upon filing of timely written application by the owner or consignee and the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as the Secretary of Health and Human Services may by regulation prescribe. If such application is filed and such bond is executed the Secretary of Health and Human Services may, in accordance with rules prescribed by him, permit the applicant to perform such operations with respect to such electronic product as may be specified in the notice of permission.

(c)All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of operations provided for in subsection (b) of this section, and all expenses in connection with the storage, cartage, or labor with respect to any electronic product refused admission pursuant to subsection (a) of this section, shall be paid by the owner or consignee, and, in event of default, shall constitute a lien against any future importations made by such owner or consignee.

(d)It shall be the duty of every manufacturer offering an electronic product for importation into the United States to designate in writing an agent upon whom service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made for and on behalf of said manufacturer, and to file such designation with the Secretary, which designation may from time to time be changed by like writing, similarly filed. Service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made upon said manufacturer by service upon such designated agent at his office or usual place of residence with like effect as if made personally upon said manufacturer, and in default of such designation of such agent, service of process, notice, order, requirement, or decision in any proceeding before the Secretary or in any judicial proceeding for enforcement of this part or any standards prescribed pursuant to this part may be made by posting such process, notice, order, requirement, or decision in the Office of the Secretary or in a place designated by him by regulation.

Notes & Related Subsidiaries

Editorial Notes

Codification Section was classified to section 263h 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 263h of Title 42, The Public Health and Welfare, as this section. 1992—Subsecs. (a), (b). Pub. L. 102–300 substituted “Health and Human Services” for “Health, Education, and Welfare” wherever appearing. 1990—Subsec. (a). Pub. L. 101–629, § 19(a)(1)(B), (2)(D), substituted “this part” for “this subpart”, “section 360kk(h)” for “section 263f(h)”, and “section 360kk” for “section 263f”. Subsec. (b). Pub. L. 101–629, § 19(a)(2)(D), substituted “section 360kk” for “section 263f”. Subsec. (d). Pub. L. 101–629, § 19(a)(1)(B), substituted “this part” for “this subpart” in two places.

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.

§360mm Imports