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 product may be deferred upon filing of timely written appli- cation by the owner or consignee and the execu- tion by him of a good and sufficient bond pro- viding for the payment of such liquidated dam- ages 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 per- form such operations with respect to such elec- tronic 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 de- struction provided for in subsection (a) of this section and the supervision of operations pro- vided for in subsection (b) of this section, and all expenses in connection with the storage, cart- age, or labor with respect to any electronic product refused admission pursuant to sub- section (a) of this section, shall be paid by the owner or consignee, and, in event of default, shall constitute a lien against any future impor- tations made by such owner or consignee. (d) Designation of agent for purposes of service It shall be the duty of every manufacturer of- fering an electronic product for importation into the United States to designate in writing an agent upon whom service of all administra- tive and judicial processes, notices, orders, deci- sions, and requirements may be made for and on behalf of said manufacturer, and to file such des- ignation with the Secretary, which designation may from time to time be changed by like writ- ing, similarly filed. Service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made upon said manu- facturer by service upon such designated agent at his office or usual place of residence with like effect as if made personally upon said manufac- turer, and in default of such designation of such agent, service of process, notice, order, require- ment, or decision in any proceeding before the Secretary or in any judicial proceeding for en- forcement of this part or any standards pre- scribed 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. (June 25, 1938, ch. 675, § 536, formerly act July 1, 1944, ch. 373, title III, § 536, formerly § 360, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1181; renumbered § 536 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(D), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 102–300, § 6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) 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 AGENCIES Enactment of this section not to be construed to su- persede or limit the functions under any other provi- sion 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 (a) Inspection of premises If the Secretary finds for good cause that the methods, tests, or programs related to elec- tronic 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 em- Page 411 TITLE 21—FOOD AND DRUGS § 360nn ployees 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 manu- facturer’s tests (or testing programs) required by section 360kk(h) of this title are carried out, and (2) to inspect, at reasonable times and with- in reasonable limits and in a reasonable manner, the facilities and procedures within such area which are related to electronic product radi- ation safety. Each such inspection shall be com- menced and completed with reasonable prompt- ness. 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 in- troduced into commerce any electronic product which does not comply with an applicable stand- ard prescribed under this part and with respect to which no exemption from the notification re- quirements 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 (in- cluding 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 act- ing in compliance with this part and standards prescribed pursuant to this part and shall, upon request of an officer or employee duly des- ignated 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 act- ing in compliance with standards prescribed pur- suant 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 nec- essary 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 pro- ceeding arising out of such accident. Any such officer, employee, or agent may be required to testify in such proceedings as to the facts devel- oped in such investigations. Any such report shall be made available to the public in a man- ner which need not identify individuals. All re- ports 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 other- wise obtained by him, pursuant to subsection (a) or (b) of this section, which concerns any infor- mation which contains or relates to a trade se- cret 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 infor- mation by the Secretary, or by any officers or employees under his control, from the duly au- thorized 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 pre- scribed under this part and the retail prices of which is not less than $50, to furnish manufac- turers 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 re- quirement pursuant to clause (1) of the pre- ceding sentence shall (A) authorize such dealers and distributors to elect, in lieu of immediately furnishing such information to the manufac- turer, to hold and preserve such information until advised by the manufacturer or Secretary that such information is needed by the manufac- turer 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 informa- tion 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, im- mediately furnish the manufacturer with the re- quired information. If a dealer or distributor discontinues the dealing in or distribution of electronic products, he shall turn the informa- tion over to the manufacturer. Any manufac- turer receiving information pursuant to this subsection concerning first purchasers of prod- ucts 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. (June 25, 1938, ch. 675, § 537, formerly act July 1, 1944, ch. 373, title III, § 537, formerly § 360A, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered § 537 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(E), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) 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 Page 412 TITLE 21—FOOD AND DRUGS § 360oo of Title 42, The Public Health and Welfare, as this sec- tion. 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), sub- stituted ‘‘this part’’ for ‘‘this subpart’’ wherever ap- pearing. Subsec. (f). Pub. L. 101–629, § 19(a)(1)(B), (2)(E)(ii), sub- stituted ‘‘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 AGENCIES Enactment of this section not to be construed to su- persede or limit the functions under any other provi- sion 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. § 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 appli- cable standard prescribed pursuant to section 360kk of this title; (2) for any person to fail to furnish any noti- fication or other material or information re- quired by section 360ll or 360nn of this title; or to fail to comply with the requirements of sec- tion 360ll(f) of this title; (3) for any person to fail or to refuse to es- tablish 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; (4) for any person to fail or to refuse to make any report required pursuant to section 360nn(b) of this title or to furnish or preserve any information required pursuant to section 360nn(f) of this title; or (5) for any person (A) to fail to issue a cer- tification as required by section 360kk(h) of this title, or (B) to issue such a certification when such certification is not based upon a test or testing program meeting the require- ments of section 360kk(h) of this title or when the issuer, in the exercise of due care, would have reason to know that such certification is false or misleading in a material respect. (b) The Secretary may exempt any electronic product, or class thereof, from all or part of sub- section (a), upon such conditions as he may find necessary to protect the public health or wel- fare, for the purpose of research, investigations, studies, demonstrations, or training, or for rea- sons of national security. (June 25, 1938, ch. 675, § 538, formerly act July 1, 1944, ch. 373, title III, § 538, formerly § 360B, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered § 538 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(F), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) Editorial Notes CODIFICATION Section was classified to section 263j 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 263j of Title 42, The Public Health and Welfare, as this sec- tion. 1990—Subsec. (a)(1). Pub. L. 101–629, § 19(a)(2)(F)(i), substituted ‘‘section 360kk’’ for ‘‘section 263f’’. Subsec. (a)(2). Pub. L. 101–629, § 19(a)(2)(F)(ii), (iii), substituted ‘‘section 360ll or 360nn’’ for ‘‘section 263g or 263i’’ and ‘‘section 360ll(f)’’ for ‘‘section 263g(f)’’. Subsec. (a)(3). Pub. L. 101–629, § 19(a)(1)(B), (2)(F)(iii), substituted ‘‘this part’’ for ‘‘this subpart’’ and ‘‘section 360nn’’ for ‘‘section 263i’’. Subsec. (a)(4). Pub. L. 101–629, § 19(a)(2)(F)(iii), sub- stituted ‘‘section 360nn(b)’’ for ‘‘section 263i(b)’’ and ‘‘section 360nn(f)’’ for ‘‘section 263i(f)’’. Subsec. (a)(5). Pub. L. 101–629, § 19(a)(2)(F)(i), sub- stituted ‘‘section 360kk(h)’’ for ‘‘section 263f(h)’’ in two places. Statutory Notes and Related Subsidiaries NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment of this section not to be construed to su- persede or limit the functions under any other provi- sion 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. § 360pp. Enforcement (a) Jurisdiction of courts The district courts of the United States shall have jurisdiction, for cause shown, to restrain violations of section 360oo of this title and to re- strain dealers and distributors of electronic products from selling or otherwise disposing of electronic products which do not conform to an applicable standard prescribed pursuant to sec- tion 360kk of this title except when such prod- ucts are disposed of by returning them to the distributor or manufacturer from whom they were obtained. The district courts of the United States shall also have jurisdiction in accordance with section 1355 of title 28 to enforce the provi- sions of subsection (b) of this section. (b) Penalties (1) Any person who violates section 360oo of this title shall be subject to a civil penalty of not more than $1,000. For purposes of this sub- section, any such violation shall with respect to each electronic product involved, or with re- spect to each act or omission made unlawful by section 360oo of this title, constitute a separate violation, except that the maximum civil pen- alty imposed on any person under this sub- section for any related series of violations shall not exceed $300,000. (2) Any such civil penalty may on application be remitted or mitigated by the Secretary. In determining the amount of such penalty, or whether it should be remitted or mitigated and in what amount, the appropriateness of such penalty to the size of the business of the person charged and the gravity of the violation shall be considered. The amount of such penalty, when finally determined, may be deducted from any