21 U.S.C. § 360mm: Imports

Summary

Electronic products brought into the United States must meet the required safety standards and must have the proper certification label or tag. If a product does not meet the rules or lacks the right label, it will be denied entry. Treasury must give samples of imports to the Department of Health and Human Services (HHS) if HHS asks. The owner or consignee will be told and can ask for a hearing. If HHS finds the product is not compliant, it will be refused entry and Treasury will destroy it unless the owner exports it within 90 days (or longer if allowed by rules). If HHS thinks the product can be fixed, the owner can apply and post a required bond. With a bond and permission, the owner may do specified work to bring the product into compliance. The owner must pay all related expenses (including travel, per diem, government salaries, storage, transport, and labor). Unpaid costs can become a lien on future imports. Manufacturers must name and file a written agent to receive legal papers. If they do not, papers may be posted at the Secretary’s office.

Title 21, §360mm

Food and Drugs, Source: USLM XML via OLRC

(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 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)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 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)Liability of owner or consignee for expenses connected with refusal of admission

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)Designation of agent for purposes of service

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