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agency or organization, and may pay therefor in advance or by way of reimbursement, and in such installments, as he may determine.

(k) State laws unaffected.

Nothing in this section shall be construed as affecting the power of any State to enact and enforce laws relating to the matters covered by this section to the extent that such laws are not inconsistent with the provisions of this section or with the rules and regulations issued under this section.

(1) State law coverage exemption.

Where a State has enacted or hereafter enacts laws relating to matters covered by this section, which provide for standards equal to or more stringent than the provisions of this section or than the rules and regulations issued under this section, the Secretary may exempt clinical laboratories in that State from compliance with this section. (July 1, 1944, ch. 373, title III, § 353, as added Dec. 5, 1967, Pub. L. 90-174, § 5(a), 81 Stat. 536.)

EFFECTIVE DATE

Section 5(b) of Pub. L. 90-174 provided that: "The amendment made by subsection (a) [enacting this section] shall become effective on the first day of the thirteenth month after the month [December 1967] in which it is enacted, except that the Secretary of Health, Education, and Welfare may postpone such effective date for such additional period as he finds necessary, but not beyond the first day of the 19th month after such month [December 1967] in which the amendment is enacted."

SHORT TITLE

Section 5(c) of Pub. L. 90–174 provided that: "This section [enacting this section and note provisions under this section] may be cited as the 'Clinical Laboratories Improvement Act of 1967.' "'

DEFINITION OF "SECRETARY"

Term "Secretary" used in this section as meaning the Secretary of Health, Education, and Welfare, see section 15 of Pub. L. 90-174, set out as a note under section 201 of this title.

Subpart 3.-Electronic Product Radiation Control

§ 263b. Congressional declaration of purpose.

The Congress hereby declares that the public health and safety must be protected from the dangers of electronic product radiation. Thus, it is the purpose of this subpart to provide for the establishment by the Secretary of an electronic product radiation control program which shall include the development and administration of performance standards to control the emission of electronic product radiation from electronic products and the undertaking by public and private organizations of research and investigation into the effects and control of such radiation emissions. (July 1, 1944, ch. 373, title III, § 354, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3), 82 Stat. 1173.)

SHORT TITLE

Section 1 of Pub. L. 90 602 provided that: "This Act [enacting this subpart and provisions set out as notes under this section] may be cited as the 'Radiation Control for Health and Safety Act of 1968'."

DEFINITION OF "SECRETARY" AND "DEPARTMENT" Section 3 of Pub. L. 90–602 provided that: "As used in the amendments made by section 2 of this Act [enacting this subpart], except when otherwise specified, the term

'Secretary' means the Secretary of Health, Education, and Welfare, and the term 'Department' means the Department of Health, Education, and Welfare."

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Section 4 of Pub. L. 90–602 provided that: "The amendments made by section 2 of this Act [enacting this subpart] shall not be construed as superseding or limiting the functions, under any other provision of law, of any offcer or agency of the United States."

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 263c-263n of this title.

§ 263c. Definitions.

As used in this subpart

(1) the term "electronic product radiation"

means

(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or

(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product;

(2) the term "electronic product" means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation;

(3) the term "manufacturer" means any person engaged in the business of manufacturing, assembling, or importing of electronic products;

(4) the term "commerce" means (A) commerce between any place in any State and any place outside thereof; and (B) commerce wholly within the District of Columbia; and

(5) the term "State" includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa. (July 1, 1944, ch. 373, title III, § 355, as added Oct. 18, 1968, Pub. L. 90-602, § 2(3), 82 Stat. 1174.)

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment 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 263b of this title.

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 263b, 263d-263n of this title.

§ 263d. Program of control. (a) Establishment.

The Secretary shall establish and carry out an electronic product radiation control program designed to protect the public health and safety from electronic product radiation. As a part of such program, he shall

(1) pursuant to section 263f of this title, develop and administer performance standards for electronic products;

(2) plan, conduct, coordinate, and support research, development, training, and operational activities to minimize the emissions of and the exposure of people to, unnecessary electronic product radiation;

(3) maintain liaison with and receive information from other Federal and State departments and agencies with related interests, professional organizations, industry, industry and labor associations, and other organizations on present and future potential electronic product radiation;

(4) study and evaluate emissions of, and conditions of exposure to, electronic product radiation and intense magnetic fields;

(5) develop, test, and evaluate the effectiveness of procedures and techniques for minimizing exposure to electronic product radiation; and

(6) consult and maintain liaison with the Secretary of Commerce, the Secretary of Defense, the Secretary of Labor, the Atomic Energy Commission, and other appropriate Federal departments and agencies on (A) techniques, equipment, and programs for testing and evaluating electronic product radiation, and (B) the development of performance standards pursuant to section 263f of this title to control such radiation emissions.

(b) Powers of Secretary.

In carrying out the purposes of subsection (a) of this section, 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 electronic product radiation; and (B) make such recommendations relating to such hazards and control as he considers appropriate;

(2) make grants to public and private agencies, organizations, and institutions, and to individuals 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 individuals, without regard to section 529 of Title 31 and section 5 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 sections this subpart pursuant to grants or contracts entered into under other than competitive bidding procedures shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such assistance, the total cost of the project or undertaking in connection 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 authorized

representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipients that are pertinent to the grants or contracts entered into under this subpart under other than competitive bidding procedures. (July 1, 1944, ch. 373, title III, § 356, as added Oct. 18, 1968, Pub. L. 90-602, § 2(3), 82 Stat. 1174.)

DEFINITION OF "SECRETARY" AND "DEPARTMENT"

The terms "Secretary" and "Department" as used in this section, except when otherwise specified, to mean Secretary of Health, Education, and Welfare and Department of Health, Education, and Welfare, respectively, see section 3 of Pub. L. 90-602, set out as a note under section 263b of this title.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment of this section not to be construed to supersede or limit the functions under any other provision 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 263b of this title.

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263b, 263c, 263c263n of this title.

§ 263e. Studies by the 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 control 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 radioactive materials other than material regulated under the Atomic Energy Act of 1954;

(B) any gaps and inconsistencies in present controls;

(C) the need for controlling the sale of certain used electronic products, particularly antiquated X-ray equipment, without upgrading such products to meet the standards for new products or separate standards for used products;

(D) measures to assure consistent and effective control of the aforementioned health hazards; (E) measures to strengthen radiological health programs of State governments; and

(F) the feasibility of authorizing the Secretary to enter into arrangements with individual 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 nonmedical electronic products for commercial and industrial 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 applicable standard established pursuant to this subpart.

(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 responsibilities and interests, State

governments-particularly those of States which regulate radioactive materials under section 2021 of this title and interested professional, labor, and industrial organizations. Upon request from congressional committees interested in these studies, the Secretary shall keep these committees currently informed 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 Secretary shall be included in the report if so requested by the dissenter. (July 1, 1944, ch. 373, title III, § 357, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3), 82 Stat. 1176.)

REFERENCES IN TEXT

The Atomic Energy Act of 1954, referred to in text, is act Aug. 30, 1954, ch. 1073, 68 Stat. 921, which is classified to section 2011 et seq. of this title.

DEFINITION OF "SECRETARY" and "DeparTMENT"

The terms "Secretary" and "Department" as used in this section, except when otherwise specified, to mean Secretary of Health, Education, and Welfare and Department of Health, Education, and Welfare, respectively, see section 3 of Pub. L. 90–602, set out as a note under section 263b of this title.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment 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 263b of this title.

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 263b-263d, 263f263n of this title.

§ 263f. 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 radiation 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 electronic 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 products. 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 development of such standards, the Secretary shall consult with Federal and State departments and agencies having related responsibilities or interests and with appropriate professional organizations and interested persons, including representatives of industries and labor organizations which would be affected by such standards, and shall give consideration to

(A) the latest available scientific and medical data in the field of electronic product radiation;

(B) the standards currently recommended by (1) other Federal agencies having responsibilities 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 feasibility of such standards as applied to a particular 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 263c 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 operating characteristics and uses.

(3) The performance standards prescribed under this section shall not apply to any electronic product which is intended solely for export if (A) such product and the outside of any shipping container used in the export of such product are labeled or tagged to show that such product is intended for export, and (B) such product meets all the applicable requirements of the country to which such product is intended for export.

(4) The Secretary may by regulation amend or revoke any performance standard prescribed under this section.

(5) The Secretary may exempt from the provisions of this section any electronic product intended for use by departments or agencies of the United States provided such department or agency has prescribed procurement specifications governing emissions of electronic product radiation and provided further that such product is of a type used solely or predominantly by departments or agencies of the United States.

(b) Administrative procedure.

The provisions of subchapter II of chapter 5 of Title 5 (relating to the administrative procedure for rulemaking), and of chapter 7 of Title 5 (relating to judicial review), shall apply with respect to any regulation prescribing, amending, or revoking any standard prescribed under this section.

(c) Publication in Federal Register.

Each regulation prescribing, amending, or revoking a standard shall specify the date on which it shall take effect which, in the case of any regulation prescribing, or amending any standard, may not be sooner than one year or not later than two years after the date on which such regulation is issued, unless the Secretary finds, for good cause shown, that an earlier or later effective date is in the public interest and publishes in the Federal Register his

I

reason for such finding, in which case such earlier or later date shall apply. (d) Judicial review.

(1) In a case of actual controversy as to the validity of any regulation issued under this section prescribing, amending, or revoking a performance standard, any person who will be adversely affected by such regulation when it is effective may at any time prior to the sixtieth day after such regulation is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such regulation. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based the regulation, as provided in section 2112 of Title 28.

(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendations, if any, for the modification or setting aside of his original regulation, with the return of such additional evidence.

(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to review the regulation in accordance with chapter 7 of Title 5 and to grant appropriate relief as provided in such chapter.

(4) The judgment of the court affirming or setting aside, in whole or in part, any such regulation of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of Title 28.

(5) Any action instituted under this subsection shall survive, notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in addition to and not substitution for any other remedies provided by law.

(e) Availability of record.

A certified copy of the transcript of the record and administrative proceedings under this section shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, exclusion of imports, or other proceeding arising under or in respect of this subpart irrespective of whether proceedings with respect to the regulation have previously been initiated or become final under this section.

(f) Technical Electronic Product Radiation Safety Standards Committee.

(1) (A) The Secretary shall establish a Technical Electronic Product Radiation Safety Standards Committee (hereafter in this subpart referred to as the "Committee") which he shall consult before prescribing any standard under this section. The Committee shall be appointed by the Secretary, after consultation with public and private agencies concerned with the technical aspects of electronic product radiation safety, and shall be composed of fifteen members each of whom shall be technically qualified by training and experience in one or more fields of science or engineering applicable to electronic product radiation safety, as follows:

(1) Five members shall be selected from governmental agencies including State and Federal Governments;

(ii) Five members shall be selected from the affected industries after consultation with industry representatives; and

(iii) Five members shall be selected from the general public, of which at least one shall be a representative of organized labor.

(B) The Committee may propose electronic product radiation safety standards to the Secretary for his consideration. All proceedings of the Committee shall be recorded and the record of each such proceeding shall be available for public inspection.

(2) Payments to members of the Committee who are not officers or employees of the United States pursuant to section 210(c) of this title shall not render members of the Committee 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 of tag permanently affixed to such product or in such manner as approved by the Secretary, the certification that such product 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 product radiation or that it does not assure that electronic products comply with the standards prescribed under this section. (July 1, 1944, ch. 373, title III, § 358, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3), 82 Stat. 1177, amended Oct. 30, 1970, Pub. L. 91-515, title VI, § 601(b) (2), (3), 84 Stat. 1311.)

AMENDMENTS

1970-Subsec. (f) (2). Pub. L. 91-515 struck out the provisions which related to the payment of compensation and travel expenses of members of the Committee who are not officers or employees of the United States, and substituted "to members of the Committee who are not officers or employees of the United States pursuant to section 210 (c) of this title" for "under this subsection".

DEFINITION OF "SECRETARY" AND "DEPARTMENT”

The terms "Secretary" and "Department" as used in this section, except when otherwise specified, to mean Secretary of Health, Education, and Welfare and Department of Health, Education, and Welfare, respectively, see section 3 of Pub. L. 90-602, set out as a note under section 263b of this title.

NONINTERFERENCE WITH OTHER FEDERAL AGENCIES Enactment 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 263b of this title.

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 263b-263e, 263g263n of this title.

§ 263g. Notification of defects in and repair or replacement of electronic products.

(a) Notification; exemption.

(1) Every manufacturer of electronic products who discovers that an electronic product produced, assembled, or imported by him has a defect 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 263f of this title fails to comply with such standard, shall immediately notify the Secretary of such defect or failure to comply if such product has left the place of manufacture and shall (except as authorized 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 create a significant risk of injury, including genetic 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) of this section. If such application states reasonable grounds for such exemption, the Secretary shall afford such manufacturer 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 satisfied that such defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he shall exempt such manufacturer from the requirement of notice to the persons specified in subsection (b) of this section and from the requirements of repair or replacement imposed by subsection (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 product; and

(2) by certified mail or other more expeditious 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 evaluation of the hazard reasonably related to such defect 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 regarding defects.

Every manufacturer of electronic products shall furnish to the Secretary a true or representative copy of all notices, bulletins, and other communications to the dealers or distributors of such manufacturer or to purchasers (or subsequent transferees) of electronic products of such manufacturer regarding any such defect in such product or any such failure to comply with a standard applicable to such product. The Secretary shall disclose to the public so much of the information contained in such notice or other information obtained under section 2631 of this title as he deems will assist in carrying out the purposes of this subpart, 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 subpart.

(e) Notice from Secretary to manufacturer of defects or failure to comply with standards.

If through testing, inspection, investigation, or research carried out pursuant to this subpart, or examination of reports submitted pursuant to section 2631 of this title, or otherwise, the Secretary determines that any electronic product

(1) does not comply with an applicable standard prescribed pursuant to section 263f 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 Secretary 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 radiation 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 263f of this title, or that it contains a defect which relates to the safety of use of such product by reason of the emission of

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