21 U.S.C. § 360jj — Studies by Secretary

Page 405 TITLE 21—FOOD AND DRUGS § 360jj the exposure of people to, unnecessary elec- tronic product radiation; (3) maintain liaison with and receive infor- mation from other Federal and State depart- ments and agencies with related interests, professional organizations, industry, industry and labor associations, and other organiza- tions on present and future potential elec- tronic product radiation; (4) study and evaluate emissions of, and con- ditions of exposure to, electronic product radi- ation and intense magnetic fields; (5) develop, test, and evaluate the effective- ness of procedures and techniques for mini- mizing exposure to electronic product radi- ation; and (6) consult and maintain liaison with the Secretary of Commerce, the Secretary of De- fense, the Secretary of Labor, the Atomic En- ergy Commission, and other appropriate Fed- eral departments and agencies on (A) tech- niques, equipment, and programs for testing and evaluating electronic product radiation, and (B) the development of performance stand- ards pursuant to section 360kk of this title to control such radiation emissions. (b) Powers of Secretary In carrying out the purposes of subsection (a), the Secretary is authorized to— (1)(A) collect and make available, through publications and other appropriate means, the results of, and other information concerning, research and studies relating to the nature and extent of the hazards and control of elec- tronic product radiation; and (B) make such recommendations relating to such hazards and control as he considers appropriate; (2) make grants to public and private agen- cies, organizations, and institutions, and to in- dividuals for the purposes stated in paragraphs (2), (4), and (5) of subsection (a) of this section; (3) contract with public or private agencies, institutions, and organizations, and with indi- viduals, without regard to section 3324 of title 31 and section 6101 of title 41; and (4) procure (by negotiation or otherwise) electronic products for research and testing purposes, and sell or otherwise dispose of such products. (c) Record keeping (1) Each recipient of assistance under this part pursuant to grants or contracts entered into under other than competitive bidding proce- dures shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such re- cipient of the proceeds of such assistance, the total cost of the project or undertaking in con- nection with which such assistance is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit. (2) The Secretary and the Comptroller General of the United States, or any of their duly au- thorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the re- cipients that are pertinent to the grants or con- tracts entered into under this part under other than competitive bidding procedures. (June 25, 1938, ch. 675, § 532, formerly act July 1, 1944, ch. 373, title III, § 532, formerly § 356, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1174; renumbered § 532 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(A), (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 In subsec. (b)(3), ‘‘section 6101 of title 41’’ substituted for ‘‘section 3709 of the Revised Statutes of the United States (41 U.S.C. 5)’’ on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts. Section was classified to section 263d 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 263d of Title 42, The Public Health and Welfare, as this section. 1990—Subsec. (a)(1), (6). Pub. L. 101–629, § 19(a)(2)(A)(i), substituted ‘‘section 360kk’’ for ‘‘section 263f’’. Subsec. (b)(3). Pub. L. 101–629, § 19(a)(2)(A)(ii), sub- stituted reference to section 3324 of title 31 for ref- erence to section 3648 of the Revised Statutes (31 U.S.C. 529). Subsec. (c)(1), (2). Pub. L. 101–629, § 19(a)(1)(B), sub- stituted ‘‘this part’’ for ‘‘this subpart’’. Statutory Notes and Related Subsidiaries TRANSFER OF FUNCTIONS Atomic Energy Commission abolished and functions transferred by sections 5814 and 5841 of Title 42, The Public Health and Welfare. See also Transfer of Func- tions notes set out under those sections. 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 or 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. § 360jj. Studies by Secretary (a) Report to Congress The Secretary shall conduct the following studies, and shall make a report or reports of the results of such studies to the Congress on or before January 1, 1970, and from time to time thereafter as he may find necessary, together with such recommendations for legislation as he may deem appropriate: (1) A study of present State and Federal con- trol of health hazards from electronic product radiation and other types of ionizing radiation, which study shall include, but not be limited to— (A) control of health hazards from radio- active materials other than materials regu- lated under the Atomic Energy Act of 1954 [42 U.S.C. 2011 et seq.]; (B) any gaps and inconsistencies in present controls; (C) the need for controlling the sale of cer- tain used electronic products, particularly an- tiquated X-ray equipment, without upgrading such products to meet the standards for new products or separate standards for used prod- ucts; Page 406 TITLE 21—FOOD AND DRUGS § 360kk (D) measures to assure consistent and effec- tive control of the aforementioned health haz- ards; (E) measures to strengthen radiological health programs of State governments; and (F) the feasibility of authorizing the Sec- retary to enter into arrangements with indi- vidual States or groups of States to define their respective functions and responsibilities for the control of electronic product radiation and other ionizing radiation; (2) A study to determine the necessity for the development of standards for the use of nonmed- ical electronic products for commercial and in- dustrial purposes; and (3) A study of the development of practicable procedures for the detection and measurement of electronic product radiation which may be emitted from electronic products manufactured or imported prior to the effective date of any ap- plicable standard established pursuant to this part. (b) Participation of other Federal agencies In carrying out these studies, the Secretary shall invite the participation of other Federal departments and agencies having related respon- sibilities and interests, State governments—par- ticularly those of States which regulate radio- active materials under section 274 of the Atomic Energy Act of 1954, as amended [42 U.S.C. 2021], and interested professional, labor, and industrial organizations. Upon request from congressional committees interested in these studies, the Sec- retary shall keep these committees currently in- formed as to the progress of the studies and shall permit the committees to send observers to meetings of the study groups. (c) Organization of studies and participation The Secretary or his designee shall organize the studies and the participation of the invited participants as he deems best. Any dissent from the findings and recommendations of the Sec- retary shall be included in the report if so re- quested by the dissenter. (June 25, 1938, ch. 675, § 533, formerly act July 1, 1944, ch. 373, title III, § 533, formerly § 357, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1176; renumbered § 533 and amended Pub. L. 101–629, § 19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.) Editorial Notes REFERENCES IN TEXT The Atomic Energy Act of 1954, referred to in subsec. (a)(1)(A), is act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch. 1073, § 1, 68 Stat. 919, which is classified principally to chapter 23 (§ 2011 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 2011 of Title 42 and Tables. CODIFICATION Section was classified to section 263e 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 263e of Title 42, The Public Health and Welfare, as this sec- tion. 1990—Subsec. (a)(3). Pub. L. 101–629, § 19(a)(1)(B), sub- stituted ‘‘this part’’ for ‘‘this subpart’’. 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. § 360kk. Performance standards for electronic products (a) Promulgation of regulations (1) The Secretary shall by regulation prescribe performance standards for electronic products to control the emission of electronic product ra- diation from such products if he determines that such standards are necessary for the protection of the public health and safety. Such standards may include provisions for the testing of such products and the measurement of their elec- tronic product radiation emissions, may require the attachment of warning signs and labels, and may require the provision of instructions for the installation, operation, and use of such prod- ucts. Such standards may be prescribed from time to time whenever such determinations are made, but the first of such standards shall be prescribed prior to January 1, 1970. In the devel- opment of such standards, the Secretary shall consult with Federal and State departments and agencies having related responsibilities or inter- ests and with appropriate professional organiza- tions and interested persons, including rep- resentatives of industries and labor organiza- tions which would be affected by such standards, and shall give consideration to— (A) the latest available scientific and med- ical data in the field of electronic product ra- diation; (B) the standards currently recommended by (i) other Federal agencies having responsibil- ities relating to the control and measurement of electronic product radiation, and (ii) public or private groups having an expertise in the field of electronic product radiation; (C) the reasonableness and technical feasi- bility of such standards as applied to a par- ticular electronic product; (D) the adaptability of such standards to the need for uniformity and reliability of testing and measuring procedures and equipment; and (E) in the case of a component, or accessory described in paragraph (2)(B) of section 360hh of this title, the performance of such article in the manufactured or assembled product for which it is designed. (2) The Secretary may prescribe different and individual performance standards, to the extent appropriate and feasible, for different electronic products so as to recognize their different oper- ating characteristics and uses. (3) The performance standards prescribed under this section shall not apply to any elec- tronic product which is intended solely for ex- port if (A) such product and the outside of any shipping container used in the export of such