21 U.S.C. § 360ll — Notification of defects in and repair or re-

Page 408 TITLE 21—FOOD AND DRUGS § 360ll States pursuant to subsection (c) of section 210 of title 42 shall not render members of the Com- mittee officers or employees of the United States for any purpose. (g) Review and evaluation The Secretary shall review and evaluate on a continuing basis testing programs carried out by industry to assure the adequacy of safeguards against hazardous electronic product radiation and to assure that electronic products comply with standards prescribed under this section. (h) Product certification Every manufacturer of an electronic product to which is applicable a standard in effect under this section shall furnish to the distributor or dealer at the time of delivery of such product, in the form of a label or tag permanently affixed to such product or in such manner as approved by the Secretary, the certification that such prod- uct conforms to all applicable standards under this section. Such certification shall be based upon a test, in accordance with such standard, of the individual article to which it is attached or upon a testing program which is in accord with good manufacturing practice and which has not been disapproved by the Secretary (in such manner as he shall prescribe by regulation) on the grounds that it does not assure the adequacy of safeguards against hazardous electronic prod- uct radiation or that it does not assure that electronic products comply with the standards prescribed under this section. (June 25, 1938, ch. 675, § 534, formerly act July 1, 1944, ch. 373, title III, § 534, formerly § 358, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1177; amended Pub. L. 91–515, title VI, § 601(b)(2), (3), Oct. 30, 1970, 84 Stat. 1311; renumbered § 534 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §§ 3(w), 4(a)(2), Aug. 13, 1993, 107 Stat. 778, 779.) Editorial Notes CODIFICATION Section was classified to section 263f of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629. AMENDMENTS 1993—Pub. L. 103–80, § 4(a)(2), amended directory lan- guage of Pub. L. 101–629, § 19(a)(4), which renumbered section 263f of Title 42, The Public Health and Welfare, as this section. Subsec. (f)(2). Pub. L. 103–80, § 3(w), made technical amendment to reference to section 210 of title 42 to re- flect correction of corresponding provision of original act. 1990—Subsec. (a)(1)(E). Pub. L. 101–629, § 19(a)(2)(B), substituted ‘‘section 360hh’’ for ‘‘section 263c’’. Subsecs. (e), (f)(1)(A). Pub. L. 101–629, § 19(a)(1)(B), substituted ‘‘this part’’ for ‘‘this subpart’’. 1970—Subsec. (f)(2). Pub. L. 91–515 struck out provi- sions related to payment of compensation and travel expenses of members of the Committee who are not of- ficers or employees of the United States, and sub- stituted ‘‘to members of the Committee who are not of- ficers or employees of the United States pursuant to subsection (c) of section 210 of title 42’’ for ‘‘under this subsection’’. 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. § 360ll. Notification of defects in and repair or re- placement of electronic products (a) Notification; exemption (1) Every manufacturer of electronic products who discovers that an electronic product pro- duced, assembled, or imported by him has a de- fect 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 fails to comply with such standard, shall imme- diately notify the Secretary of such defect or failure to comply if such product has left the place of manufacture and shall (except as au- thorized 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 cre- ate a significant risk of injury, including ge- netic 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 man- ufacturer 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 satis- fied that such defect or failure to comply is not such as to create a significant risk of injury, in- cluding genetic injury, to any person, he shall exempt such manufacturer from the require- ment of notice to the persons specified in sub- section (b) of this section and from the require- ments of repair or replacement imposed by sub- section (f) of this section. (b) Method of notification The notification (other than to the Secretary) required by paragraph (1) of subsection (a) of this section shall be accomplished— (1) by certified mail to the first purchaser of such product for purposes other than resale, and to any subsequent transferee of such prod- uct; and (2) by certified mail or other more expedi- tious means to the dealers or distributors of such manufacturer to whom such product was delivered. (c) Requisite elements of notification The notifications required by paragraph (1) of subsection (a) of this section shall contain a clear description of such defect or failure to comply with an applicable standard, an evalua- tion of the hazard reasonably related to such de- Page 409 TITLE 21—FOOD AND DRUGS § 360ll fect or failure to comply, and a statement of the measures to be taken to repair such defect. In the case of a notification to a person referred to in subsection (b) of this section, the notification shall also advise the person of his rights under subsection (f) of this section. (d) Copies to Secretary of communications by manufacturers to dealers or distributors re- garding defects Every manufacturer of electronic products shall furnish to the Secretary a true or rep- resentative copy of all notices, bulletins, and other communications to the dealers or dis- tributors of such manufacturer or to purchasers (or subsequent transferees) of electronic prod- ucts of such manufacturer regarding any such defect in such product or any such failure to comply with a standard applicable to such prod- uct. The Secretary shall disclose to the public so much of the information contained in such no- tice or other information obtained under section 360nn of this title as he deems will assist in car- rying out the purposes of this part, but he shall not disclose any information which contains or relates to a trade secret or other matter referred to in section 1905 of title 18 unless he determines that it is necessary to carry out the purposes of this part. (e) Notice from Secretary to manufacturer of de- fects or failure to comply with standards If through testing, inspection, investigation, or research carried out pursuant to this part, or examination of reports submitted pursuant to section 360nn of this title, or otherwise, the Sec- retary determines that any electronic product— (1) does not comply with an applicable standard prescribed pursuant to section 360kk of this title; or (2) contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation; he shall immediately notify the manufacturer of such product of such defect or failure to comply. The notice shall contain the findings of the Sec- retary and shall include all information upon which the findings are based. The Secretary shall afford such manufacturer an opportunity to present his views and evidence in support thereof, to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the product by reason of the emission of such radi- ation hazard. If after such presentation by the manufacturer the Secretary determines that such product does not comply with an applicable standard prescribed pursuant to section 360kk of this title, or that it contains a defect which re- lates to the safety of use of such product by rea- son of the emission of electronic product radi- ation, the Secretary shall direct the manufac- turer to furnish the notification specified in sub- section (c) of this section to the persons speci- fied in paragraphs (1) and (2) of subsection (b) of this section (where known to the manufacturer), unless the manufacturer has applied for an ex- emption from the requirement of such notifica- tion on the ground specified in paragraph (2) of subsection (a) and the Secretary is satisfied that such noncompliance or defect is not such as to create a significant risk of injury, including ge- netic injury, to any person. (f) Correction of defects If any electronic product is found under sub- section (a) or (e) to fail to comply with an appli- cable standard prescribed under this part or to have a defect which relates to the safety of use of such product, and the notification specified in subsection (c) is required to be furnished on ac- count of such failure or defect, the manufac- turer of such product shall (1) without charge, bring such product into conformity with such standard or remedy such defect and provide re- imbursement for any expenses for transpor- tation of such product incurred in connection with having such product brought into con- formity or having such defect remedied, (2) re- place such product with a like or equivalent product which complies with each applicable standard prescribed under this part and which has no defect relating to the safety of its use, or (3) make a refund of the cost of such product. The manufacturer shall take the action required by this subsection in such manner, and with re- spect to such persons, as the Secretary by regu- lations shall prescribe. (g) Effective date This section shall not apply to any electronic product that was manufactured before October 18, 1968. (June 25, 1938, ch. 675, § 535, formerly act July 1, 1944, ch. 373, title III, § 535, formerly § 359, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered § 535 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(C), (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 263g 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 263g of Title 42, The Public Health and Welfare, as this section. 1990—Subsec. (a)(1). Pub. L. 101–629, § 19(a)(2)(C)(i), substituted ‘‘section 360kk’’ for ‘‘section 263f’’. Subsec. (d). Pub. L. 101–629, § 19(a)(1)(B), (2)(C)(ii), sub- stituted ‘‘section 360nn’’ for ‘‘section 263i’’ and ‘‘this part’’ for ‘‘this subpart’’ in two places. Subsec. (e). Pub. L. 101–629, § 19(a)(1)(B), (2)(C), sub- stituted ‘‘this part’’ for ‘‘this subpart’’ and ‘‘section 360nn’’ for ‘‘section 263i’’ in introductory provisions and ‘‘section 360kk’’ for ‘‘section 263f’’ in par. (1) and con- cluding provisions. Subsec. (f). 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. 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-