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96 STAT. 2051

for a drug designated under section 526 for a rare disease or Ante, p. 2050. condition and for which a United States Letter of Patent may not be issued, the Secretary may not approve another application under section 505(b) or issue another license under section 351 of the 21 USC 355. Public Health Service Act for such drug for such disease or condi- 42 USC 262. tion for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 505(c)(2) does not apply to the refusal to approve an application under the preceding sentence. "(b) If an application filed pursuant to section 505(b) is approved for a drug designated under section 526 for a rare disease or condition or a license is issued under section 351 of the Public Health Service Act for such a drug and if a United States Letter of Patent may not be issued for the drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 505(b), or, if the drug is a biological product, issue a license under section 351 of the Public Health Service Act, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if— "(1) The Secretary finds, after providing the holder notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or "(2) such holder provides the Secretary in writing the consent 1 of such holder for the approval of other applications or the issuance of other licenses before the expiration of such sevenyear period. "OPEN PROTOCOLS FOR INVESTIGATIONS OF DRUGS FOR RARE DISEASES OR CONDITIONS

^ "SEC. 528. If a drug is designated under section 526 as a drug for a rare disease or condition and if notice of a claimed exemption under section 505(i) or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.". (b) Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting before section 501 the following: "SUBCHAPTER A—DRUGS AND DEVICES.". ORPHAN PRODUCTS BOARD

SEC. 3. Title II of the Public Health Service Act is amended by adding at the end the following:

21 USC 360dd.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/690

 96 STAT. 2052

PUBLIC LAW 97-414—JAN. 4, 1983 "ORPHAN PRODUCTS BOARD

Establishment. 42 USC 236.

Ante, p. 2049.

I, V

21 USC 355.

42 USC 262.

"SEC. 227. (a) There is established in the Department of Health and Human Services a board for the development of drugs (including biologies) and devices (including diagnostic products) for rare diseases or conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for Health of the Department of Health and Human Services and representatives, selected by the Secretary, of the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control, and any other Federal department or agency which the Secretary determines has activities relating to drugs and devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the Board. "(b) The function of the Board shall be to promote the development of drugs and devices for rare diseases or conditions and the coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of such articles for such diseases or conditions. "(c) In the case of drugs for rare diseases or conditions the Board shall— "(Devaluate— -• "(A) the effect of subchapter B of the Federal Food, Drug, ii and Cosmetic Act on the development of such drugs, and "(B) the implementation of such subchapter; « "(2) evaluate the activities of the National Institutes of Tii Health and the Alcohol, Drug Abuse, and Mental Health Administration for the development of drugs for such diseases "(3) assure appropriate coordination among the Food and Drug Administration, the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, and the Centers for Disease Control in the carrying out of their j respective functions relating to the development of ^rugs for such diseases or conditions to assure that the activities of each agency are complementary, "(4) assure appropriate coordination among all interested Federal agencies, manufacturers, and organizations representing patients, in their activities relating to such drugs, "(5) with the consent of the sponsor of a drug for a rare disease or condition exempt under section 5(y5(i) of the Federal Food, Drug, and Cosmetic Act or regulations issued under such section, inform physicians and the public respecting the availability of such drug for such disease or condition and inform physicians and the public respecting the availability of drugs ,; approved under section 505(c) of such Act or licensed under ' •' section 351 of this Act for rare diseases or conditions, "(6) seek business entities and others to undertake the sponsorship of drugs for rare diseases or conditions, seek investigators to facilitate the development of such drugs, and seek business entities to participate in the distribution of such drugs, and "(7) recognize the efforts of public and private entities and '" individuals in seeking the development of drugs for rare diseases or conditions and in developing such drugs. "(d) The Board shall consult with interested persons respecting the activities of the Board under this section and as part of such
 * ii'. or conditions,

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 PUBLIC LAW 97-414—JAN. 4, 1983

96 STAT. 2053

consultation shall provide the opportunity for the submission of oral views. "(e) The Board shall submit to the Committee on Labor and Report to Human Resources of the Senate and the Committee on Energy and congressional Commerce of the House of Representatives an annual report— commi "(1) identifying the drugs which have been designated under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or condition, "(2) describing the activities of the Board, and "(3) containing the results of the evaluations carried out by the Board. The Director of the National Institutes of Health and the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration shall submit to the Board for inclusion in the annual report a .,.., report on the rare disease and condition research activities of the ' ' Institutes of the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration; the Secretary of the Treasury shall submit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by section 44H of the Internal Revenue Code of 1954; and the Secretary infra. of Health and Human Services shall submit to the Board for inclusion in the annual report a report on the program of assistance under section 5 of the Orphan Drug Act for the development of Post, p. 2056 drugs for rare diseases and conditions. Each annual report shall be submitted by June 1 of each year for the preceding calendar year.". TAX CREDIT FOR TESTING EXPENSES FOR DRUGS FOR RARE DISEASES OR CONDITIONS

SEC. 4. (a) Subpart A of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1954 (relating to credits allowable) is amended by inserting after section 44G the following new section: "SEC. 44H. CLINICAL TESTING EXPENSES FOR CERTAIN DRUGS FOR RARE DISEASES OR CONDITIONS.

"(a) GENERAL RULE.—There shall be allowed as a credit against the tax imposed by this chapter for the taxable year an amount equal to 50 percent of the qualified clinical testing expenses for the taxable year. "(b) QUALIFIED CUNICAL TESTING EXPENSES.—For purposes of this section— "(1) QUALIFIED CLINICAL TESTING EXPENSES.—

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"(A) IN GENERAL.—Except as otherwise provided in this paragraph, the term 'qualified clinical testing expenses' means the amounts which are paid or incurred by the taxpayer during the taxable year which would be described in subsection (b) of section 44F if such subsection were applied with the modifications set forth in subparagraph (B). "(B) MODIFICATIONS.—For purposes of subparagraph (A), subsection (b) of section 44F shall be applied— "(i) by substituting 'clinical testing' for 'qualified research' each place it appears in paragraphs (2) and (3) of such subsection, and "(ii) by substituting '100 percent' for '65 percent' in paragraph (3)(A) of such subsection.

26 USC 44H.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/692

 96 STAT. 2054

PUBLIC LAW 97-414—JAN. 4, 1983 SI' *

"(C) EXCLUSION FOR AMOUNTS FUNDED BY GRANTS, ETC.—

The term 'qualified clinical testing expenses' shall not inelude any amount to the extent such amount is funded by any grant, contract, or otherwise by another person (or any governmental entity). "(D) SPECIAL RULE.—For purposes of this paragraph, section 44F shall be deemed to remain in effect for periods after December 31, 1985.

''

"(2) CLINICAL TESTING.—

••f(i

"(A) IN GENERAL.—The term 'clinical testing' means any human clinical testing— "(i) which is carried out under an exemption for a drug being tested for a rare disease or condition under section 505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section), "(ii) which occurs— "(I) after the date of such drug is designated under section 526 of such Act, and "(II) before the date on which an application with respect to such drug is approved under section 505(b) of such Act, and "(iii) which is conducted by or on behalf of the taxpayer to whom the designation under such section 526 applies.

21 USC 355.

"(B) TESTING MUST BE RELATED TO USE FOR RARE DISEASE OR

Ante, p. 2050.

CONDITION.—Human clinical testing shall be taken into account under subparagraph (A) only to the extent such testing is related to the use of a drug for the rare disease or condition for which it was designated under section 526 of the Federal Food, Drug, and Cosmetic Act.

"(c) COORDINATION WITH CREDIT FOR INCREASING RESEARCH EXPENDITURES.—

=

"(1) IN GENERAL.—Except as provided in paragraph (2), any qualified clinical testing expenses for a taxable year to which an election under this section applies shall not be taken into account for purposes of determining the credit allowable under section 44F for such taxable year.

••••'•

"(2) EXPENSES INCLUDED IN DETERMINING BASE PERIOD RE-

SEARCH EXPENSES.—Any qualified clinical testing expenses for any taxable year which are qualified research expenses (within i the meaning of section 44F(b)) shall be taken into account in determining base period research expenses for purposes of applying section 44F to subsequent taxable years. "(d) DEFINITION AND SPECIAL RULES.-:"(1) RARE DISEASE OR CONDITION.—For

purposes of this section, the term 'rare disease or condition' means any disease or condition which occurs so infrequently in the United States that there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date such drug is designated under section 526 of the Federal Food, Drug, and Cosmetic Act. "(2) LIMITATION BASED ON AMOUNT OF TAX.—The credit al-

V lowed by this section for any taxable year shall not exceed the amount of the tax imposed by this chapter for the taxable year

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Page:United States Statutes at Large Volume 96 Part 2.djvu/693

 PUBLIC LAW 97-414—JAN. 4, 1983

96 STAT. 2055

reduced by the sum of the credits allowable under a section of this subpart having a lower number or letter designation than this section, other than the credits allowable by sections 31, 39, and 43. For purposes of the preceding sentence, the term 'tax imposed by this chapter' shall not include any tax treated as not imposed by this chapter under the last sentence of section 53(a). (3) SPECIAL LIMITATIONS ON FOREIGN TESTING.—

1

^ ''' fo e

"(A) IN GENERAL.—No credit shall be allowed under this section with respect to any clinical testing conducted outside the United States unless— "(i) such testing is conducted outside the United States because there is an insufficient testing population in the United States, and "(ii) such testing is conducted by a United States person or by any other person who is not related to the taxpayer to whom the designation under section 526 of the Federal Food, Drug, and Cosmetic Act applies. "(B) SPECIAL LIMITATION FOR CORPORATIONS TO WHICH SEC-

TION 934(b) OR 936 APPLIES.—No Credit shall be allowed under this section with respect to any clinical testing conducted by a corporation to which section 934(b) applies or to which an election under section 936 applies. "(4) CERTAIN RULES MADE APPLICABLE.—Rules similar to

':.

the

rules of paragraphs (1) and (2) of section 44F(f) shall apply for purposes of this section. "(5) ELECTION.—This section shall apply to any taxpayer for any taxable year only if such taxpayer elects (at such time and in such manner as the Secretary may by regulations prescribe) to have this section apply for such taxable year. "(e) TERMINATION.—This section shall not apply to any amount paid or incurred after December 31, 1987." (b)(l) Section 280C of such Code (relating to denial of deduction for portion of wages for which credit is claimed under section 40 or 44B) is amended by adding at the end thereof the following new subsection:

9

2;

26 USC 280C.

"(c) CREDIT FOR QUALIFIED CUNICAL TESTING EXPENSES FOR CERTAIN DRUGS.—

"(1) IN GENERAL.—No deduction shall be allowed for that portion of the qualified clinical testing expenses (as defined in section 44H(b)) otherwise allowable as a deduction for the taxable year which is equal to the amount of the credit allowable for the taxable year under section 44H (determined without regard to subsection (d)(2) thereof). "(2) SIMILAR RULE WHERE TAXPAYER CAPITAUZES RATHER THAN DEDUCTS EXPENSES.—If—

"(A) the amount of the credit allowable for the taxable year under section 44H (determined without regard to subsection (d)(2) thereof), exceeds "(B) the amount allowable as a deduction for the taxable year for qualified clinical testing expenses (determined without regard to paragraph (1)), the amount chargeable to capital account for the taxable year for such expenses shall be reduced by the amount of such excess. "(3) CONTROLLED GROUPS.—In the case of a corporation which is a member of a controlled group of corporations (within the meaning of section 44F(f)(5)) or a trade or business which is

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Page:United States Statutes at Large Volume 96 Part 2.djvu/694

 96 STAT. 2056

PUBLIC LAW 97-414—JAN. 4, 1983

treated as being under common control with other trades or business (within the meaning of section 44F(f)(l)(B)), this subsection shall be applied under rules prescribed by the Secretary similar to the rules applicable under subparagraphs (A) and (B) of section 44F(f)(l)." (2)(A) The section heading of section 280C of such Code is amended to read as follows: "SEC. 280C. CERTAIN EXPENSES FOR WHICH CREDITS ARE ALLOWABLE."

(B) The table of sections for part IX of subchapter B of chapter 1 of such Code is amended by striking out the item relating to section 280C and inserting in lieu thereof the following: "Sec. 280C. Certain expenses for which credits are allowable."

(c)(1) The table of sections for subpart A of part IV of subchapter A of chapter 1 of such Code is amended by inserting after the item relating to section 44G the following new item: "Sec. 44H. Clinical testing expenses for certain drugs for rare diseases or conditions." 26 USC 6096. 26 USC 44H note.

(2) Subsection (b) of section 6096 of such Code is amended by striking out "and 44G" and inserting in lieu thereof "44G, and 44H. (d) The amendments made by this section shall apply to amounts paid or incurred after December 31, 1982, in taxable years ending after such date. „. „..__,,,,„ . GRANTS AND CONTRACTS FOR DEVELOPMENT OF DRUGS FOR RARE DISEASES AND CONDITIONS

21 USC 360ee.

'}&..}

"Qualified clinical testing."

Ante, p. 2050.

21 USC 355. "Rare disease or condition."

SEC. 5. (a) The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in defraying the costs of qualified clinical testing expenses incurred in connection with the development of drugs for rare diseases and conditions. (b) For purposes of subsection (a): (1) The term "qualified clinical testing" means any human clinical testing— (A) which is carried out under an exemption for a drug irub for a rare disease or condition under section 505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section), (B) which occurs— (i) after the date such drug is designated under section 526 of such Act, and '?,)•;' (ii) before the date on which an application with respect to such drug is submitted under section 5050)) of such Act. (2) The term "rare disease or condition" means any disease or condition which occurs so infrequently in the United States that there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made. zi ivjiiW'v ii5';*->niPi? TO i'-f-

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Page:United States Statutes at Large Volume 96 Part 2.djvu/695

 PUBLIC LAW 97-414—JAN. 4, 1983

96 STAT. 2057

(c) For grants and contracts under subsection (a) there are authorized to be appropriated $4,000,000 for fiscal year 1983 and for each of the next two fiscal years.

Appropriation authorization.

HOME HEALTH SERVICES

. SEC. 6. (a) Part D of title III of the Public Health Service Act is amended by inserting after subpart II the following new subpart:
 * rr

"SUBPART III—HOME HEALTH SERVICES O' i

HOME HEALTH SERVICES

i;

"SEC. 339. (a)(1) For the purpose of encouraging the establishment and initial operation of home health programs to provide home health services in areas in which such services are inadequate or not readily accessible, the Secretary may, in accordance with the provisions of this section, make grants to public and nonprofit private entities and loans to proprietary entities to meet the initial costs of establishing and operating such home health programs. Such grants and loans may include funds to provide training for paraprofessionals (including homemaker home health aides) to provide home health services. "(2) In making grants and loans under this subsection, the Secretary shall— "(A) consider the relative needs of the several States for home health services; "(B) give preference to areas in which a high percentage of the population proposed to be served is composed of individuals who are elderly, medically indigent, or disabled; and "(C) give special consideration to areas with inadequate means of transportation to obtain necessary health services. "(3)(A) No loan may be made to a proprietary entity under this section unless the application of such entity for such loan contains assurances satisfactory to the Secretary that— "(i) at the time the application is made the entity is fiscally sound; "(ii) the entity is unable to secure a loan for the project for which the application is submitted from non-Federal lenders at f the rate of interest prevailing in the area in which the entity is located; and , "(iii) during the period of the loan, such entity will remain fiscally sound. "(B) Loans under this section shall be made at an interest rate comparable to the rate of interest prevailing on the date the loan is made with respect to the marketable obligations of the United States of comparable maturities, adjusted to provide for administrative costs. "(4) Applications for grants and loans under this subsection shall be in such form and contain such information as the Secretary shall prescribe. "(5) There are authorized to be appropriated for grants and loans under this subsection $5,000,000 for each of the fiscal years ending on September 30, 1983, and September 30, 1984. "(b)(1) The Secretary may make grants to and enter into contracts with public and private entities to assist them in developing appro-

Grants. 42 USC 255.

Appropriation authorization.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/696

 96 STAT. 2058

Appropriation authorization. Report to congressional committees.

42 USC 1395x. Report and recommendations to Congress. 42 USC 255 note. 42 USC 255 note.

PUBLIC LAW 97-414—JAN. 4, 1983

priate training programs for paraprofessionals (including homemaker home health aides) to provide home health services. "(2) Any program established with a grant or contract under this subsection to train homemaker home health aides shall— "(A) extend for at least forty hours, and consist of classroom instruction and at least twenty hours (in the aggregate) of ^ • supervised clinical instruction directed toward preparing stu- dents to deliver home health services; "(B) be carried out under appropriate professional supervision and be designed to train students to maintain or enhance the personal care of an individual in his home in a manner which promotes the functional independence of the individual; and "(C) include training in— "(i) personal care services designed to assist an individual in the activities of daily living such as bathing, exercising, personal grooming, and getting in and out of bed; and "(ii) household care services such as maintaining a safe living environment, light housekeeping, and assisting in providing good nutrition (by the purchasing and preparation of food). "(3) In making grants and entering into contracts under this subsection, special consideration shall be given to entities which establish or will establish programs to provide training for persons fifty years of age and older who wish to become paraprofessionals (including homemaker home health aides) to provide home health services. "(4) Applications for grants and contracts under this subsection shall be in such form and contain such information as the Secretary shall prescribe. "(5) There are authorized to be appropriated for grants and contracts under this subsection $2,000,000 for each of the fiscal years ending September 30, 1983, and September 30, 1984. "(c) The Secretary shall report to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives on or before January 1, 1984, with respect to— "(1) the impact of grants made and contracts entered into under subsections (a) and (b) (as such subsections were in effect prior to October 1, 1981); "(2) the need to continue grants and loans under subsections (a) and (b) (as such subsections are in effect on the day after the j^. date of enactment of the Orphan Drug Act); and "(3) the extent to which standards have been applied to the training of personnel who provide home health services. "(d) For purposes of this section, the term 'home health services' has the meaning prescribed for the term by section 1861(m) of the Social Security Act.". (b) The Secretary shall report the results of studies currently evaluating home and community based health services, and any recommendations for legislative action which might improve the provision of such services, to the Congress prior to January 1, 1985. (c) The Secretary of Health and Human Services shall compile and analyze the results of significant studies carried out by any public or private entity, group, or individual, relating to current and alternative reimbursement methodologies for home health services. The Secretary shall make recommendations with respect to such reimbursement methodologies as they might be applied in health care

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Page:United States Statutes at Large Volume 96 Part 2.djvu/697

 PUBLIC LAW 97-414—JAN. 4, 1983

96 STAT. 2059

programs funded in whole or in part by Federal funds, and report such recommendations to the Congress within 180 days after the date of the enactment of this Act. (d) The Secretary of Health and Human Services, acting through the Inspector General of the Department of Health and Human Services, shall undertake a thorough investigation of— (1) the methods available to stem fraud and abuse in the provision of home health services under medicare and medicaid; and (2) the extent to which such methods are applied in stemming such fraud and abuse. The Secretary shall report the results of the investigation to the Congress within 18 months after the date of the enactment of this Act. (e)(1) The Secretary of Health and Human Services shall develop and carry out demonstration projects commencing no later than January 1, 1984, to test— (A) methods for identifying patients at risk of institutionalization who could be treated more cost-effectively with home health services and other non-institutional health services; and (B) alternative reimbursement methodologies for home health agencies in order to determine the most cost-effective and efficient way of providing home health services. (2) Methods for identifying patients at risk of institutionalization to be tested by the Secretary under paragraph (1)(A) may include, but not be limited to, the identification of hospitalized medicare patients who are candidates for early discharge due to availability of home health services and individuals in the community who could avoid institutionalization with the availability of home health services. (3) Reimbursement methodologies to be tested by the Secretary under paragraph (1)(B) may include but not be limited to fee schedules, prospective reimbursement, and capitation payments. (4) The Secretary shall report to Congress his findings with regard to the demonstrations carried out under paragraph (1) no later than January 1, 1985. (f) For purposes of this section, the term "home health services" has the meaning prescribed for the term by section 1861(m) of the Social Security Act.

Investigation. 42 USC 255 note.

Report to Congress. 42 USC 255 note.

Report to Congress. "Home health services." 42 USC 255 note. 42 USC 1395x.

ANALYSIS OF THYROID CANCER; ACTIONS BY SECRETARY

SEC. 7. (a) In carrying out section 301 of the Public Health Service Act, the Secretary of Health and Human Services shall— (1) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the risks of thyroid cancer that are associated with thyroid doses of Iodine 131; (2) conduct scientific research and prepare analyses necessary to develop valid and credible methods to estimate the thyroid doses of Iodine 131 that are received by individuals from nuclear bomb fallout; (3) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the exposure to Iodine 131 that the American people received from the Nevada atmospheric nuclear bomb tests; and

42 USC 241 note. 42 USC 241.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/698

 96 STAT. 2060 Report to Congress. Radioepidemiological tables, publication.

.t,-»J*

Update of tables.

PUBLIC LAW 97-414—JAN. 4, 1983

(4) prepare and transmit to the Congress within one year after the date of enactment of this Act a report with respect to the activities conducted in carrying out paragraphs (1), (2), and (3). (b)(l) Within one year after the date of enactment of this Act, the Secretary of Health and Human Services shall devise and publish radioepidemiological tables that estimate the likelihood that persons who have or have had any of the radiation related cancers and who have received specific doses prior to the onset of such disease developed cancer as a result of these doses. These tables shall show a probability of causation of developing each radiation related cancer associated with receipt of doses ranging from 1 millirad to 1,000 rads in terms of sex, age at time of exposure, time from exposure to the onset of the cancer in question, and such other categories as the Secretary, after consulting with appropriate scientific experts, determines to be relevant. Each probability of causation shall be calculated and displayed as a single percentage figure. (2) At the time the Secretary of Health and Human Services publishes the tables pursuant to paragraph (1), such Secretary shall also publish— .., (A) for the tables of each radiation related cancer, an evaluation which will assess the credibility, validity, and degree of certainty associated with such tables; and T (B) a compilation of the formulas that yielded the probabilities of causation listed in such tables. Such formulas shall be ,, published in such a manner and together with information individual who has or has had a radiation related cancer and has received any given dose. (3) The tables specified in paragraph (1) and the formulas specified in paragraph (2) shall be devised from the best available data that are most applicable to the United States, and shall be devised in accordance with the best available scientific procedures and expertise. The Secretary of Health and Human Services shall update these tables and formulas every four years, or whenever he deems it necessary to insure that they continue to represent the best available scientific data and expertise. TECHNICAL AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT
 * necessary to determine the probability of causation of any

SEC. 8. (a) Section 207(a)(1) of such Act (42 U.S.C. 209(a)(1)) is amended by inserting "psychology," after "pharmacy,". (b) Section 306(1)(2) of such Act (42 U.S.C. 242k(l)(2)) is amended by striking out subparagraph (D) and redesignating subparagraphs (E), (F), and (G) as subparagraphs (D), (E), and (F), respectively. (c) Section 308(d) of such Act (42 U.S.C. 242m(d)) is amended (1) by inserting ", if an establishment or person supplying the information or described in it is identifiable," after "No information", and (2) by striking out "authorized by guidelines in effect under section 306(1)(2) or under regulations of the Secretary" and inserting in lieu thereof "such establishment or person has consented (as determined under regulations of the Secretary) to its use for such other purpose". (d) The first sentence of section 311(c)(2) of such Act (42 U.S.C. 243(c)(2)) is amended by striking out "forty-five days" and inserting instead "six months". (e) Section 330(d)(2) of such Act (42 U.S.C. 254c(d)(2)) is amended by inserting before "and the costs" the following: ", the costs of repay-

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 PUBLIC LAW 97-414-JAN. 4, 1983

96 STAT. 2061

ing loans made by the Farmers Home Administration for buildings,". (0 Section 337(a) of such Act (42 U.S.C. 254j(a)) is amended by striking out "carrying out this subpart" and inserting in lieu thereof "carrying out this subpart (other than section 338G)". (g)(1) Section 338B(e) of the Public Health Service Act (42 U.S.C. 254m-(e)) is amended by inserting before the period the following: "or under section 225 as in effect on September 30, 1977". (2) Section 338D(b) of such Act (42 U.S.C. 294w(b)) is amended by striking out "section 338F(b)" and inserting in lieu thereof "section 338E(d)". (3) Section 338E(d)(l) of such Act (42 U.S.C. 294x(d)(l)) is amended by striking out "section 338D(c)" and inserting in lieu thereof "section 338D(b)". (h) Section 340(g) of the Public Health Service Act (42 U.S.C. 256(g)) is amended (1) by striking out "and" after "1980," in paragraph (1) and by inserting before the period in that paragraph a comma and "and $3,000,000 for the fiscal year ending September 30, 1982", and (2) by inserting "and" after "1980," in paragraph (2) and by striking out in that paragraph ", and $3,000,000 for the fiscal year ending September 30, 1982". (i) Section 737(2) of such Act (42 U.S.C. 294jX2)) is amended by inserting "in a State" after "means a school". (j) Section 781(a)(2) of such Act (42 U.S.C. 295g-l(a)(2)) is amended by striking out "under area health education center programs". (k)(l) Section 791A(b)(3)(A) of such Act (42 U.S.C. 295h-la(b)(3)(A)) is amended by striking out "postbaccalaureate" and inserting in lieu

»,

.

42 USC 254o. 42 USC 254p.

.,,.,.,,,,

(2) Section 791(c)(2)(A) of such Act (42 U.S.C. 295h(c)(2)(A)) is amended to read as follows: "(A) such application contains assurances satisfactory to the Secretary that in the school year (as defined in regulations of the Secretary) beginning in the fiscal year for which the applicant receives a grant under subsection (a) that— "(i) at least 25 individuals will complete the graduate 3,f educational programs of the entity for which such applica1^ tion is submitted; and "(ii) such entity shall expend or obligate at least $100,000 in funds from non-Federal sources to conduct such programs; and". (1) Section 831(b) of such Act (42 U.S.C. 297-1(b)) is amended by inserting before the period a comma and the following: "$400,000 for the fiscal year ending September 30, 1983, and $800,000 for the fiscal year ending September 30, 1984". (m) Title VIII of such Act is amended by adding at the end thereof the following: "TECHNICAL ASSISTANCE

"SEC. 857. Funds appropriated under this title may be used by the Secretary to provide technical assistance in relation to any of the authorities under this title.". (n) Sections 1001(c), 1003(b), and 1005(b) of such Act (42 U.S.C. 300(c), 300a-l(b), 300a-3(b)) are each amended by striking out the comma after "1981" and inserting in lieu thereof a semicolon. (o) Section 1101(b) of such Act (42 U.S.C. 300ba))) (as in effect before its repeal by section 2193(b)(1) of the Omnibus Budget Reconciliation Act of 1981 is amended by inserting a comma after "1981".

42 USC 298b-4. ,,,^,, ' '

95 Stat. 826.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/700

 96 STAT. 2062 95 Stat. 571. 42 USC 300q-2. ,^^, '"

'

-.., ^

PUBLIC LAW 97-414—JAN. 4, 1983

(p) Section 1536 of such Act (42 U.S.C. 300n-5) (as amended by section 935 of the Omnibus Budget Reconciliation Act of 1981) is amended by striking out "this title and" and inserting in lieu thereof "this title and—". (q) Section 1602(0(2) of such Act (42 U.S.C. 300g-2(f)(2)) is amended by inserting after "including" the following: "selling real property pledged as security for such a loan or loan guarantee and". (r)(l) The matter in section 1706(a) (42 U.S.C. 300u-5(a)) of the Public Health Service Act preceding paragraph (1) is amended by striking out "Health Information, Health Promotion and Physical Fitness and Sports Medicine" and inserting instead "Health promotion". (2) The section heading for section 1706 of such Act (42 U.S.C. 300u-5) is amended to read as follows: "OFFICE OF HEALTH PROMOTION".

42 USC 300X.

42 USC 241.

42 USC 2689 note, 9401 "

.-, V 42 USC 241. 42 USC 4571, 4578. 95 Stat. 595. 21 USC 1176, ^^^^

(s) The second sentence of section 1904(a)(1)(F) of such Act (42 U.S.C. 300w-3(a)(l)(F)) is amended by striking out "equipment for the systems" and inserting in lieu thereof "equipment for the systems (other than systems with respect to which grants were made as prescribed by section 1905(c)(2))". (t) Effective October 1, 1982, section 1912(b) of such Act (42 U.S.C. 300x-l(b)) is amended to read as follows: "(b)(1) From the remainder of the amount appropriated under section 1911 for any fiscal year, the Secretary shall allot to each State an amount which bears the same ratio to such remainder for that fiscal year as the amounts— "(A) which would have been provided by the Secretary to the State and entities in the State under section 301 of this Act for mental health services demonstrations and under the Community Mental Health Centers Act and the Mental Health Systems Act for mental health services for fiscal year 1981 if the Secretary had obligated all the funds for such purposes available for such Acts under Public Law 96-536, and "(B) provided by the Secretary to the State and entities in the State under the laws referred to in subparagraphs (D) and (E) of paragraph (2) for fiscal year 1980, bore to the total amount appropriated for mental health services demonstrations and mental health services for fiscal year 1981 under Public Law 96-536 for section 301 of this Act, the Community Mental Health Centers Act and the Mental Health Systems Act and ^jjg ^otj^j amouut appropriated for fiscal year 1980 for the provisions of law referred to in subparagraphs (D) and (E) of paragraph (2). "(2) The provisions of law referred to in paragraph (1) are the following provisions of law as in effect on the day before the date of the enactment of the Omnibus Budget Reconciliation Act of 1981: "(A) The Community Mental Health Centers Act. "(B) The Mental Health Systems Act. "(C) Section 301 of this Act. "(D) Sections 301 and 312 of the Comprehensive Alcohol Abuse and Alcoholism, Prevention, Treatment, and Rehabilitation Act of 1970. "(E) Sections 409 and 410 of the Drug Abuse Prevention, Treatment, and Rehabilitation Act. "(3) For purposes of paragraph (1), the total amount appropriated under Public Law 96-536 for mental health services demonstrations

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Page:United States Statutes at Large Volume 96 Part 2.djvu/701

 PUBLIC LAW 97-414—JAN. 4, 1983

96 STAT. 2063

under section 301 of this Act shall be deemed not to exceed $20,000,000; and if such total amount did exceed $20,000,000, the amount that would have been provided to each State and entities in each State shall be ratably reduced for purposes of paragraph (1)(A) to conform to the limit prescribed by this paragraph. "(4) To the extent that all the funds appropriated under section 1911 for a fiscal year and available for allotment in such fiscal year are not otherwise allotted to States because— "(A) one or more States have not submitted an application or description of activities in accordance with section 1915 for the 42 USC 300x-4. J fiscal year; ^ "(B) one or more States have notified the Secretary that they do not intend to use the full amount of their allotment; or "(C) some State allotments are offset or repaid under section 1916(b)(3); 42 USC 300X-5. such excess shall be allotted among each of the remaining States in proportion to the amount otherwise allotted to such States for the fiscal year without regard to this paragraph.". (u)(l) section 1915(c)(5) of such Act (42 U.S.C. 300x-4(c)(5)) is amended (1) by inserting "procedures for" before "procedural", and (2) by striking out "review procedures" and inserting in lieu thereof "review". (2)(A) Section 1915(c)(6)(A)(i) of such Act (42 U.S.C. 300x4(c)(6)(A)(i)) is amended— (i) by striking out "for mental health services"; (ii) by inserting "for mental health services" after "fiscal year 1981"; (iii) by inserting "for mental health services demonstrations under section 301 of this Act" before "if the Secretary"; and (iv) by striking out "such Acts" each place it occurs and inserting in lieu thereof "such provisions of law". (B) Section 1915(c)(6)(A)(ii) of such Act (42 U.S.C. 300x-4(c)(6)(A)(ii)) is amended— (i) by striking out "for mental health services"; (ii) by inserting "for mental health services" after "fiscal year 1981"; (iii) by inserting "and for mental health services demonstrations under section 301 of this Act" before "if the Secretary"; and (iv) by striking out "such Acts" and inserting in lieu thereof "such provisions of law", (v) Section 1932 of such Act is amended by— 95 Stat. 559. (1) inserting "(a)" after "1932.", and 42 USC 300y-ll. (2) adding a new subsection (b) as follows: "(b) The Secretary shall promulgate separate regulations govern- Regulations. ing the administration of this part. Such regulations shall take into account the distinctive features of the grant program authorized under this part.". (w) From the funds appropriated under section 419B of such Act 42 USC 2871 or under any other applicable provision of law, the Secretary of ^o^usc 287" Health and Human Services shall provide for the development and support of not less than ten comprehensive centers for sickle cell disease.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/702

 96 STAT. 2064

PUBLIC LAW 97-414—JAN. 4, 1983 MISCELLANEOUS TECHNICAL AMENDMENTS

95 Stat. 570. 42 USC 300, dooa-i, 300a-3. 95 Stat. 572. 42 USC 300m. 95 Stat. 573. 42 USC 300e-l. 95 Stat. 593. 42 USC 4577. 95 Stat. 593. 95 Stat. 594. 42 USC 4588. 95 Stat. 922. 42 USC 295g-^.

SEC. 9. (a) Section 931(a) of the Omnibus Budget Reconciliation Act of 1981 is amended by striking out " '1980/ " in paragraphs (1), (2), and (3) and inserting in lieu thereof " '1980;' ". ^^^ Section 936(b)(1) of the Omnibus Budget Reconciliation Act of 1981 is amended by striking out "300m(d)(l)(B)(ii)" and inserting in ligu thereof "300m(d)(l)(B)". (c) Section 942(i) of the Omnibus Budget Reconciliation Act of 1981 ig amended by striking out "'feasible (1)'" and inserting in lieu thereof " 'feasible (i)' ". (d)(1) Section 963(b)(4) of the Omnibus Budget Reconciliation Act of 1981 is amended by striking out "clause (2)" and inserting in lieu thereof "clause (3)". (2) Section 311(a)(3) of the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (42 U.S.C. 4577(b)3)) is amended by striking out the period at the end and inserting in lieu thereof a comma. (e) Section 965(a) of the Omnibus Budget Reconciliation Act of 1981 is amended by striking out paragraph (A) and by redesignating paragraphs (B), (C), and (D) as paragraphs (1), (2), and (3), respectively. (f) Section 2741(a)(3) of the Omnibus Budget Reconciliation Act of 1981 is amended by striking out "and 'and' ". (g)(1) Section 709 of the Controlled Substances Act (21 U.S.C. 904) is amended (1) by striking out subsections (a) and (b), (2) by striking out "(c)", and (3) by amending the section heading to read as follows: "PAYMENT OF TORT CLAIMS".

Repeal. 42 USC 300t-ll "°*^®-

^. J,j, .^:;::;;ni;: '' ' ^ - uj 11.^3^^

i'Oii

(2) The item relating to section 709 in the table of contents of the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by striking out "Authorizations of Appropriations" and inserting in lieu thereof "Payment of Tort Claims". (h) Section 302 of the Health Planning and Resources Development Amendments of 1979 (Public Law 96-79) is repealed. (i) The paragraph beginning with "Service and supply fund:" under the heading "PUBLIC HEALTH SERVICE" in the Federal Security Agency Appropriation Act, 1946 (42 U.S.C. 231) is amended by inserting ", or in advance," after "stock furnished". (j)(l) Section 6(b)(1) of the Consumer Product Safety Act (15 U.S.C. 2055(b)(1)) is amended by striking out "paragraph (2)" and inserting in lieu thereof "paragraph (4)". (2) section IKC) of such Act (15 U.S.C 2060(c)) is amended by striking out "section 10(e)(4)" and inserting in lieu thereof "subsection (f)". (3) Section 15(g)(1) of such Act (15 U.S.C. 2064(g)(1)) is amended by striking out "section 12(c)(1)" and inserting in lieu thereof "12(d)(1)'. (4)(A) Section 19(a)(7) of such Act (15 U.S.C. 2068(a)(7)) is amended by striking out "section 9(d)(2)" and inserting in lieu thereof "section 9(g)(2)^'. (B) Paragraph (8) of section 19(a) of such Act is repealed and paragraph (9) and the first of the two paragraphs (10) are redesignated as paragraphs (8) and (9), respectively. (5) Section 31(b)(1) of such Act (15 U.S.C. 2080(b)(1)) is amended by striking out "The Commission" and all that follows through "Substances Act," and inserting in lieu thereof the following:

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Page:United States Statutes at Large Volume 96 Part 2.djvu/703

 PUBLIC LAW 97-414—JAN. 4, 1983

96 STAT. 2065

^ "(b)(1) The Commission may not issue— "(A) an advance notice of proposed rulemaking for a consumer product safety rule, "(B) a notice of proposed rulemaking for a rule under section 27(e), or "(C) an advance notice of proposed rulemaking for regulations under section 2(q)(l) of the Federal Hazardous Substances Act,".

15 USC 1261.

(k) Section 3(a) of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1472(a)) is amended by striking out ", after consultation with the Technical Advisory Committee provided for in section 6 of this Act". (1) Section 15 of the Federal Hazardous Substances Act (15 U.S.C. 1274) (as amended by section 1211(f)(1) of the Omnibus Budget Reconciliation Act of 1982) is amended by adding at the end thereof the following: "(e) For purposes of this section (1) the term 'manufacturer' includes an importer for resale, and (2) a dealer who sells at wholesale an article or substance shall with respect to that sale be considered the distributor of that article or substance.". (m) Section 1211(h)(4) of the Omnibus Budget Reconciliation Act of 1981 is amended by striking out "by inserting ', Science and Transportation' immediately after 'on Commerce', and".

95 Stat. 721. "Manufacturer."

95 Stat. 721. i^ USC 2064.

STUDY

SEC. 10. Of the funds available under section 706 of the Energy Security Act, there shall be made available $800,000 for the costs of 42 USC 8905. a grant or contract for a study of the water quality of the Quabbin Reservoir in Massachusetts. PATENT TERM EXTENSION

SEC. 11. (a) Title 35, United States C!ode, is amended by adding the following new section: "§ 155. Patent term extension "Notwithstanding the provisions of section 154, the term of a patent which encompasses within its scope a composition of matter or a process for using such composition shall be extended if such composition or process has been subjected to a regulatory review by the Federal Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act leading to the publication of regulation permitting the interstate distribution and sale of such composition or process and for which there has thereafter been a stay of regulation of approval imposed pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act which stay was in effect on January 1, 1981, by a length of time to be measured from the date such stay of regulation of approval was imposed until such proceedings are finally resolved and commercial marketing permitted. The patentee, his heirs, successors or assigns shall notify the Commissioner of Patents and Trademarks within ninety days of the date of enactment of this section or the date the stay of regulation of approval has been removed, whichever is later, of the number of the patent to be extended and the date the stay was imposed and the date commercial marketing was permitted. On receipt of such notice, the Commissioner shall promptly issue to the owner of record

35 USC 155. 35 USC 154.

21 USC 301. 21 USC 348.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/704

 96 STAT. 2066

PUBLIC LAW 97-414—JAN. 4, 1983

of the patent a certificate of extension, under seal, stating the fact and length of the extension and identifying the composition of matter or process for using such composition to which such extension is applicable. Such certificate shall be recorded in the official file of each patent extended and such certificate shall be considered as part of the original patent, and an appropriate notice shall be '; •, J r, published in the Official Gazette of the Patent and Trademark Office.". (b) The analysis for chapter 14 of such title 35 is amended by adding at the end the following: "155. Patent term extension.".

Approved January 4, 1983.

..th'.p^ Y'l ^e-forii

\n;it,

LEGISLATIVE HISTORY—H.R. 5238: HOUSE REPORT No. 97-840 Ft. I (Comm. on Energy and Commerce). I CONGRESSIONAL RECORD, Vol. 128 (1982): .|, Sept. 28, considered and passed House. ! Oct. 1, considered and passed Senate, amended. ,^ Dec. 14, House concurred in Senate amendment with an amendment. Dec. 16, Senate concurred in House amendment. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 19, No. 1 (1983): I Jan. 4, Presidential statement.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/705

 PUBLIC LAW 97-415—JAN. 4, 1983

96 STAT. 2067

Public Law 97-415 97th Congress An Act To authorize appropriations to the Nuclear Regulatory Commission in accordance with section 261 of the Atomic Energy Act of 1954, as amended, and section 305 of the Energy Reorganization Act of 1974, as amended, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, AUTHORIZATION OF APPROPRIATIONS

1. (a) There are hereby authorized to be appropriated to the Nuclear Regulatory Commission in accordance with the provisions of section 261 of the Atomic Energy Act of 1954 (42 U.S.C. 2017) and section 305 of the Energy Reorganization Act of 1974 (42 U.S.C. 5875), for the fiscal years 1982 and 1983 to remain available until expended, $485,200,000 for fiscal year 1982 and $513,100,000 for fiscal year 1983 to be allocated as follows: (1) Not more than $80,700,000 for fiscal year 1982 and $77,000,000 for fiscal year 1983 may be used for "Nuclear Reactor Regulation", of which an amount not to exceed $1,000,000 is authorized each such fiscal year to be used to accelerate the effort in gas-cooled thermal reactor preapplication review, and an amount not to exceed $6,000,000 is authorized each such fiscal year to be used for licensing review work for a fast breeder reactor plant project. In the event of a termination of such breeder reactor project, any unused amount appropriated pursuant to this paragraph for licensing review work for such project may be used only for safety technology activities. (2) Not more than $62,900,000 for fiscal year 1982 and $69,850,000 for fiscal year 1983 may be used for "Inspection and Enforcement". (3) Not more than $42,000,000 for fiscal year 1982 and $47,059,600 for fiscal year 1983 may be used for "Nuclear Material Safety and Safeguards". (4) Not more than $240,300,000 for fiscal year 1982 and $257,195,600 for fiscal year 1983 may be used for "Nuclear Regulatory Research", of which— (A) an amount not to exceed $3,500,000 for fiscal year 1982 and $4,500,000 for fiscal year 1983 is authorized to be used to accelerate the effort in gas-cooled thermal reactor safety research; (B) an amount not to exceed $18,000,000 is authorized each such fiscal year to be used for fast breeder reactor safety research; and (C) an amount not to exceed $57,000,000 is authorized for such two fiscal year period to be used for the Loss-of-Fluid Test Facility research program. In the event of a termination of the fast breeder reactor plant project, any unused amount appropriated pursuant to this paraSECTION

97-200 O-84-pt. 2

23: QL3

Jan. 4, 1983 [H.R. 2330] Nuclear Regulatory Commission. Appropriations authorization.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/706

 96 STAT. 2068

Grants and cooperative agreements.

Reallocated funds.

Notification of congressional committees.

PUBLIC LAW 97-415—JAN. 4, 1983

graph for fast breeder reactor safety research may be used generally for "Nuclear Regulatory Research". (5) Not more than $21,900,000 for fiscal year 1982 and $20,197,800 for fiscal year 1983 may be used for "Program Technical Support". (6) Not more than $37,400,000 for fiscal year 1982 and $41,797,000 for fiscal year 1983 may be used for "Program Direction and Administration". (b) The Nuclear Regulatory Commission may use not more than 1 percent of the amounts authorized to be appropriated under subsection (a)(4) to exercise its authority under section 31 a. of the Atomic Energy Act of 1954 (42 U.S.C. 2051(a)) to enter into grants and cooperative agreements with universities pursuant to such section. Grants made by the Commission shall be made in accordance with the Federal Grant and Cooperative Agreement Act of 1977 (41 U.S.C. 501 et seq.) and other applicable law. In making such grants and entering into such cooperative agreements, the Commission shall endeavor to provide appropriate opportunities for universities in which the student body has historically been predominately comprised of minority groups. (c) Any amount appropriated for a fiscal year to the Nuclear Regulatory Commission pursuant to any paragraph of subsection (a) for purposes of the program office referred to in such paragraph, or any activity that is within such program office and is specified in such paragraph, may be reallocated by the Commission for use in a program office referred to in any other paragraph of such subsection, or for use in any other activity within a program office, except that the amount available from appropriations for such fiscal year for use in any program office or specified activity may not, as a result of reallocations made under this subsection, be increased or reduced by more than $500,000 unless— (1) a period of 30 calendar days (excluding any day in which either House of Congress is not in session because of an adjournment of more than 3 calendar days to a day certain or an adjournment sine die) passes after the receipt, by the Committee on Energy and Commerce and the Committee on Interior and Insular Affairs of the House of Representatives and the Committee on Environment and Public Works of the Senate, of notice submitted by the Commission containing a full and complete statement of the reallocation proposed to be made and the facts and circumstances relied upon in support of such proposed reallocation; or (2) each such committee, before the expiration of such period, transmits to the Commission a written notification that such committee does not object to such proposed reallocation. AUTHORITY TO RETAIN CERTAIN AMOUNTS RECEIVED

Ante, p. 948. 31 USC 3302.

SEC. 2. Moneys received by the Nuclear Regulatory Commission for the cooperative nuclear research program and the material access authorization program may be retained and used for salaries and expenses associated with such programs, notwithstanding the provisions of section 3617 of the Revised Statutes (31 U.S.C. 484), and shall remain available until expended.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/707

 PUBLIC LAW 97-415—JAN. 4, 1983

96 STAT. 2069

AUTHORITY TO TRANSFER CERTAIN AMOUNTS TO OTHER AGENCIES

SEC. 3. From amounts appropriated to the Nuclear Regulatory Commission pursuant to section 1(a), the Commission may transfer to other agencies of the Federal Government sums for salaries and expenses for the performance by such agencies of activities for which such appropriations of the Commission are made. Any sums so transferred may be merged with the appropriation of the agency to which such sums are transferred. LIMITATION ON SPENDING AUTHORITY

SEC. 4. Notwithstanding any other provision of this Act, no authority to make payments under this Act shall be effective except to such extent or in such amounts as are provided in advance in appropriation Acts. AUTHORITY TO ISSUE LICENSES IN ABSENCE OF EMERGENCY PREPAREDNESS PLANS

SEC. 5. Of the amounts authorized to be appropriated under section 1, the Nuclear Regulatory Commission may use such sums as may be necessary, in the absence of a State or local emergency preparedness plan which has been approved by the Federal Emergency Management Agency, to issue an operating license (including a temporary operating license under section 192 of the Atomic Energy Act of 1954, as amended by section 11 of this Act) for a Post, p. 207i. nuclear power reactor, if it determines that there exists a State, local, or utility plan which provides reasonable assurance that public health and safety is not endangered by operation of the facility concerned. NUCLEAR SAFETY GOALS

SEC. 6. Funds authorized to be appropriated under this Act shall be used by the Nuclear Regulatory Commission to expedite the establishment of safety goals for nuclear reactor regulation. The development of such safety goals, and any accompanying methodologies for the application of such safety goals, should be expedited to the maximum extent practicable to permit establishment of a safety goal by the Commission not later than December 31, 1982. LOSS-OF-FLUID TEST FACILITY

SEC. 7. Of the amounts authorized to be used for the Loss-of-Fluid Test Facility in accordance with section l(a)(4) for fiscal years 1982 and 1983, the Commission shall provide funding through contract with the organization responsible for the Loss-of-Fluid Test operations for a detailed technical review and analysis of research results obtained from the Loss-of-Fluid Test Facility research program. The contract shall provide funding for not more than twenty man-years in each of fiscal years 1982 and 1983 to conduct the technical review and analysis. NUCLEAR DATA LINK

SEC 8. (a) Of the amounts authorized to be appropriated under this Act for the fiscal years 1982 and 1983, not more than $200,000 is authorized to be used by the Nuclear Regulatory Commission for—

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Page:United States Statutes at Large Volume 96 Part 2.djvu/708

 96 STAT. 2070

Study and analysis.

Report to Congress. Commission action; notification of congressional committees.

PUBLIC LAW 97-415—JAN. 4, 1983

(1) the acquisition (by purchase, lease, or otherwise) and installation of equipment to be used for the "small test prototype nuclear data link" program or for any other program for the collection and transmission to the Commission of data from licensed nuclear reactors during abnormal conditions at such reactors; and (2) the conduct of a full and complete study and analysis of— (A) the appropriate role of the Commission during abnormal conditions at a nuclear reactor licensed by the Commission; (B) the information which should be available to the Commission to enable the Commission to fulfill such role and to carry out other related functions; (C) various alternative means of assuring that such information is available to the Commission in a timely manner; and (D) any changes in existing Commission authority necessary to enhance the Commission response to abnormal conditions at a nuclear reactor licensed by the Commission. The small test prototype referred to in paragraph (1) may be used by the Commission in carrying out the study and analysis under paragraph (2). Such analysis shall include a cost-benefit analysis of each alternative examined under subparagraph (C). (b)(1) Upon completion of the study and analysis required under subsection (a)(2), the Commission shall submit to Congress a detailed report setting forth the results of such study and analysis. (2) The Commission may not take any action with respect to any alternative described in subsection (a)(2)(C), unless a period of 60 calendar days (excluding any day in which either House of Congress is not in session because of an adjournment of more than 3 calendar days to a day certain or an adjournment sine die) passes after the receipt, by the Committee on Energy and Commerce and the Committee on Interior and Insular Affairs of the House of Representatives and the Committee on Environment and Public Works of the Senate, of notice submitted by the Commission containing a full and complete statement of the action proposed to be taken and the facts and circumstances relied upon in support of such proposed action. INTERIM CONSOLIDATION OF OFFICES

SEC. 9. (a) Of the amounts authorized to be appropriated pursuant to paragraph 6 of section 1(a), such sums as may be necessary shall be available for interim consolidation of Nuclear Regulatory Commission headquarters staff offices. (b) No amount authorized to be appropriated under this Act may be used, in connection with the interim consolidation of Nuclear Regulatory Commission offices, to relocate the offices of members of the Commission outside the District of Columbia. THREE MILE ISLAND

SEC. 10. (a) No part of the funds authorized to be appropriated under this Act may be used to provide assistance to the General Public Utilities Corporation for purposes of the decontamination, cleanup, repair, or rehabilitation of facilities at Three Mile Island Unit 2.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/709

 PUBLIC LAW 97-415—JAN. 4, 1983

96 STAT. 2071

(b) The prohibition contained in subsection (a) shall not relate to the responsibilities of the Nuclear Regulatory Commission for monitoring or inspection of the decontamination, cleanup, repair, or rehabilitation activities at Three Mile Island and such prohibition shall not apply to the use of funds by the Nuclear Regulatory Commission to carry out regulatory functions of the Commission under the Atomic Energy Act of 1954 with respect to the facilities at Three Mile Island. (c) The Nuclear Regulatory Commission shall include in its annual report to the Congress under section 307(c) of the Energy Reorganization Act of 1974 (42 U.S.C. 5877(c)) as a separate chapter a description of the collaborative efforts undertaken, or proposed to be undertaken, by the Commission and the Department of Energy with respect to the decontamination, cleanup, repair, or rehabilitation of facilities at Three Mile Island Unit 2. (d) No funds authorized to be appropriated under this Act may be used by the Commission to approve any willful release of "accidentgenerated water", as defined by the Commission in NUREG-0683 ("Final Programmatic Environmental Impact Statement" p. 1-23), from Three Mile Island Unit 2 into the Susquehanna River or its watershed.

42 USC 2011 note. 42 USC 5877 note.

TEMPORARY OPERATING LICENSES

SEC. 11. Section 192 of the Atomic Energy Act of 1954 (42 U.S.C. 2242) is amended to read as follows: "SEC. 192. TEMPORARY OPERATING LICENSE.—

"a. In any proceeding upon an application for an operating license for a utilization facility required to be licensed under section 103 or 104 b. of this Act, in which a hearing is otherwise required pursuant to section 189 a., the applicant may petition the Commission for a temporary operating license for such facility authorizing fuel loading, testing, and operation at a specific power level to be determined by the Commission, pending final action by the Commission on the application. The initial petition for a temporary operating license for each such facility, and any temporary operating license issued for such facility based upon the initial petition, shall be limited to power levels not to exceed 5 percent of rated full thermal power. Following issuance by the Commission of the temporary operating license for each such facility, the licensee may file petitions with the Commission to amend the license to allow facility operation in staged increases at specific power levels, to be determined by the Commission, exceeding 5 percent of rated full thermal power. The initial petition for a temporary operating license for each such facility may be filed at any time after the filing of: (1) the report of the Advisory Committee on Reactor Safeguards required by section 182 b.; (2) the filing of the initial Safety Evaluation Report by the Nuclear Regulatory Commission staff and the Nuclear Regulatory Commission staffs first supplement to the report prepared in response to the report of the Advisory Committee on Reactor Safeguards for the facility; (3) the Nuclear Regulatory Commission staffs final detailed statement on the environmental impact of the facility prepared pursuant to section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)); and (4) a State, local, or utility emergency preparedness plan for the facility. Petitions for the issuance of a temporary operating license, or for an amendment to such a license allowing operation at a specific power level greater than that authorized in the initial temporary operating

42 USC 2133, 2134. Post, p. 2073.

Initial petition.

Affidavits.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/710

 96 STAT. 2072

Publication in Federal Register.

Final order, transmittal to congressional committees.

Judicial review. 28 USC 2341 et seq. Post, p. 2073. Hearing.

PUBLIC LAW 97-415—JAN. 4, 1983

license, shall be accompanied by an affidavit or affidavits setting forth the specific facts upon which the petitioner relies to justify issuance of the temporary operating license or the amendment thereto. The Commission shall publish notice of each such petition in the Federal Register and in such trade or news publications as the Commission deems appropriate to give reasonable notice to persons who might have a potential interest in the grant of such temporary operating license or amendment thereto. Any person may file affidavits or statements in support of, or in opposition to, the petition within thirty days after the publication of such notice in the Federal Register. "b. With respect to any petition filed pursuant to subsection a. of this section, the Commission may issue a temporary operating license, or amend the license to authorize temporary operation at each specific power level greater than that authorized in the initial temporary operating license, as determined by the Commission, upon finding that— "(1) in all respects other than the conduct or completion of any required hearing, the requirements of law are met; "(2) in accordance with such requirements, there is reasonable assurance that operation of the facility during the period of the temporary operating license in accordance with its terms and conditions will provide adequate protection to the public health and safety and the environment during the period of temporary operation; and "(3) denial of such temporary operating license will result in delay between the date on which construction of the facility is sufficiently completed, in the judgment of the Commission, to permit issuance of the temporary operating license, and the date when such facility would otherwise receive a final operating license pursuant to this Act. The temporary operating license shall become effective upon issuance and shall contain such terms and conditions as the Commission may deem necessary, including the duration of the license and any provision for the extension thereof. Any final order authorizing the issuance or amendment of any temporary operating license pursuant to this section shall recite with specificity the facts and reasons justifying the findings under this subsection, and shall be transmitted upon such issuance to the Committees on Interior and Insular Affairs and Energy and Commerce of the House of Representatives and the Committee on Environment and Public Works of the Senate. The final order of the Commission with respect to the issuance or amendment of a temporary operating license shall be subject to judicial review pursuant to chapter 158 of title 28, United States Code. The requirements of section 189 a. of this Act with respect to the issuance or amendment of facility licenses shall not apply to the issuance or amendment of a temporary operating license under this section. "c. Any hearing on the application for the final operating license for a facility required pursuant to section 189 a. shall be concluded as promptly as practicable. The Commission shall suspend the temporary operating license if it finds that the applicant is not prosecuting the application for the final operating license with due diligence. Issuance of a temporary operating license under subsection b. of this section shall be without prejudice to the right of any party to raise any issue in a hearing required pursuant to section 189 a.; and failure to assert any ground for denial or limitation of a

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96 STAT. 2073

temporary operating license shall not bar the assertion of such ground in connection with the issuance of a subsequent final operating license. Any party to a hearing required pursuant to section 189 a. on the final operating license for a facility for which a temporary operating license has been issued under subsection b., and any member of the Atomic Safety and Licensing Board conducting such hearing, shall promptly notify the Commission of any information indicating that the terms and conditions of the temporary operating license are not being met, or that such terms and conditions are not sufficient to comply with the provisions of paragraph (2) of subsection b. "d. The Commission is authorized and directed to adopt such administrative remedies as the Commission deems appropriate to minimize the need for issuance of temporary operating licenses pursuant to this section. "e. The authority to issue new temporary operating licenses under this section shall expire on December 31, 1983.".

^"/^"

Expiration date,

OPERATING LICENSE AMENDMENT HEARINGS

SEC. 12. (a) Section 189 a. of the Atomic Energy Act of 1954 (42 U.S.C. 2239(a)) is amended— (1) by inserting "(1)" after the subsection designation; and (2) by adding at the end thereof the following new paragraph: "(2)(A) The Commission may issue and make immediately effective any amendment to an operating license, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. Such amendment may be issued and made immediately effective in advance of the holding and completion of any required hearing. In determining under this section whether such amendment involves no significant hazards consideration, the Commission shall consult with the State in which the facility involved is located. In all other respects such amendment shall meet the requirements of this Act. "(B) The Commission shall periodically (but not less frequently than once every thirty days) publish notice of any amendments issued, or proposed to be issued, as provided in subparagraph (A). Each such notice shall include all amendments issued, or proposed to be issued, since the date of publication of the last such periodic notice. Such notice shall, with respect to each amendment or proposed amendment (i) identify the facility involved; and (ii) provide a brief description of such amendment. Nothing in this subsection shall be construed to delay the effective date of any amendment. the effective date of this paragraph, promulgate regulations establishing (i) standards for determining whether any amendment to an operating license involves no significant hazards consideration; (ii) criteria for providing or, in emergency situations, dispensing with prior notice and reasonable opportunity for public comment on any such determination, which criteria shall take into account the exigency of the need for the amendment involved; and (iii) procedures for consultation on any such determination with the State in which the facility involved is located.". (b) The authority of the Nuclear Regulatory Commission, under the provisions of the amendment made by subsection (a), to issue and to make immediately effective any amendment to an operating
 * XC) The Commission shall, during the ninety-day period following

Notice of publication.

Regulations establishing standards, criteria, and procedures.

42 USC 2239 note.

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PUBLIC LAW 97-415—JAN. 4, 1983

license shall take effect upon the promulgation by the Commission of the regulations required in such provisions. QUAUTY ASSURANCE Resident inspector program. 42 USC 5841 note.

Commercial nuclear powerplant construction, study.

"Independent inspector."

SEC. 13. (a) The Nuclear Regulatory Commission is authorized and directed to implement and accelerate the resident inspector program so as to assure the assignment of at least one resident inspector by the end of fiscal year 1982 at each site at which a commercial nuclear powerplant is under construction and construction is more than 15 percent complete. At each such site at which construction is not more than 15 percent complete, the Commission shall provide that such inspection personnel as the Commission deems appropriate shall be physically present at the site at such times following issuance of the construction permit as may be necessary in the judgment of the Commission. (b) The Commission shall conduct a study of existing and alternative programs for improving quality assurance and quality control in the construction of commercial nuclear powerplants. In conducting the study, the Commission shall obtain the comments of the public, licensees of nuclear powerplants, the Advisory Committee on Reactor Safeguards, and organizations comprised of professionals having expertise in appropriate fields. The study shall include an analysis of the following: (1) providing a basis for quality assurance and quality control, inspection, and enforcement actions through the adoption of an approach which is more prescriptive them that currently in practice for defining principal architectural and engineering criteria for the construction of commercial nuclear powerplants; (2) conditioning the issuance of construction permits for commercial nuclear powerplants on a demonstration by the licensee that the licensee is capable of independently managing the effective performance of all quality assurance and quality control responsibilities for the powerplant; (3) evaluations, inspections, or audits of commercial nuclear powerplant construction by organizations comprised of professionals having expertise in appropriate fields which evaluations, inspections, or audits are more effective than those under current practice; (4) improvement of the Commission's organization, methods, and programs for quality assurance development, review, and inspection; and (5) conditioning the issuance of construction permits for commercial nuclear powerplemts on the permittee entering into contracts or other arrangements with an independent inspector to audit the quality assurance program to verify quality assurance performance. For purposes of paragraph (5), the term "independent inspector" means a person or other entity having no responsibility for the design or construction of the plant involved. The study shall also include an anedysis of quality assurance and quality control programs at representative sites at which such programs are operating satisfactorily and an assessment of the reasons therefor. (c) For purposes of— (1) determining the best means of assuring that commercial nuclear powerplants are constructed in accordance with the

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96 STAT. 2075

applicable safety requirements in effect pursuant to the Atomic Energy Act of 1954; and (2) assessing the feasibility and benefits of the various means listed in subsection (b); the Commission shall undertake a pilot program to review and evaluate programs that include one or more of the alternative concepts identified in subsection (b) for the purposes of assessing the feasibility and benefits of their implementation. The pilot program shall include programs that use independent inspectors for auditing quality assurance responsibilities of the licensee for the construction of commercial nuclear powerplants, as described in paragraph (5) of subsection (b). The pilot program shall include at least three sites at which commercial nuclear powerplants are under construction. The Commission shall select at least one site at which quality assurance and quality control programs have operated satisfactorily, and at least two sites with remedial programs underway at which major construction, quality assurance, or quality control deficiencies (or any combination thereof) have been identified in the past. The Commission may require any changes in existing quality assurance and quality control organizations and relationships that may be necessary at the selected sites to implement the pilot program, (d) Not later than fifteen months after the date of the enactment of this Act, the Commission shall complete the study required under subsection (b) and submit to the United States Senate and House of Representatives a report setting forth the results of the study. The report shall include a brief summary of the information received from the public and from other persons referred to in subsection (b) and a statement of the Commission's response to the significant comments received. The report shall also set forth an analysis of the results of the pilot program required under subsection (c). The report shall be accompanied by the recommendations of the Commission, including any legislative recommendations, and a description of any administrative actions that the Commission has undertaken or intends to undertake, for improving quality assurance and quality control programs that are applicable during the construction of nuclear powerplants.

42 USC 2011 note. Pilot program.

Study results, submittal to Congress.

LIMITATION ON USE OF SPECIAL NUCLEAR MATERIAL

SEC. 14. Section 57 of the Atomic Energy Act of 1954 (42 U.S.C. 2077) is amended by adding at the end thereof the following new subsection: "e. Special nuclear material, as defined in section 11, produced in facilities licensed under section 103 or 104 may not be transferred, reprocessed, used, or otherwise made available by any instrumentality of the United States or any other person for nuclear explosive purposes.". RESIDENT I N S P E C TO R S

SEC. 15. Of the amounts authorized to be appropriated under section 1, the Nuclear Regulatory Commission shall use such sums as may be necessary to conduct a study of the financial hardships incurred by resident inspectors as a result of (1) regulations of the Commission requiring resident inspectors to relocate periodically from one duty station to another; and (2) the requirements of the Commission respecting the domicile of resident inspectors and

42 USC 2014. 42 USC 2133, 2134.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/714

 96 STAT. 2076 Report to Congress.

PUBLIC LAW 97-415—JAN. 4, 1983

respecting travel between their domicile and duty station in such manner as to avoid the appearance of a conflict of interest. Not later than 90 days after the date of the enactment of this Act, the Commission shall submit to the Congress a report setting forth the findings of the Commission as a result of such study, together with a legislative proposal (including any supporting data or information) relating to any assistance for resident inspectors determined by the Commission to be appropriate. SABOTAGE OF NUCLEAR FACILITIES OR FUEL

SEC. 16. Section 236 of the Atomic Energy Act of 1954 (42 U.S.C. 2284) is amended to read as follows: "SEC. 236. SABOTAGE OF NUCLEAR FACILITIES OR FUEL.—

Penalties.

"a. Any person who intentionally and willfully destroys or causes physical damage to, or who intentionally and willfully attempts to destroy or cause physical damage to— "(1) any production facility or utilization facility licensed under this Act; "(2) any nuclear waste storage facility licensed under this Act; or "(3) any nuclear fuel for such a utilization facility, or any spent nuclear fuel from such a facility; shall be fined not more than $10,000 or imprisoned for not more than ten years, or both. "b. Any person who intentionally and willfully causes or attempts to cause an interruption of normal operation of any such facility through the unauthorized use of or tampering with the machinery, components, or controls of any such facility, shall be fined not more than $10,000 or imprisoned for not more than ten years, or both.". DEPARTMENT OF ENERGY INFORMATION

95 Stat. 1169.

Judicial review.

Quarterly report.

SEC. 17. (a) Section 148 a. (1) of the Atomic Energy Act of 1954 (42 U.S.C. 2168(a)(1)) is amended by inserting after " 'Secretary')" the following: ", with respect to atomic energy defense programs,". (b) Section 148 of the Atomic Energy Act of 1954 (42 U.S.C. 2168) is amended by adding at the end thereof the following new subsections: "d. Any determination by the Secretary concerning the applicability of this section shall be subject to judicial review pursuant to section 552(a)(4)(B) of title 5, United States Code. "e. The Secretary shall prepare on a quarterly basis a report to be made available upon the request of any interested person, detailing the Secretary's application during that period of each regulation or order prescribed or issued under this section. In particular, such report shall— "(1) identify any information protected from disclosure pursuant to such regulation or order; "(2) specifically state the Secretary's justification for determining that unauthorized dissemination of the information protected from disclosure under such regulation or order could reasonably be expected to have a significant adverse effect on the health and safety of the public or the common defense and security by significantly increasing the likelihood of illegal production of nuclear weapons, or theft, diversion, or sabotage

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Page:United States Statutes at Large Volume 96 Part 2.djvu/715

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96 STAT. 2077

of nuclear materials, equipment, or facilities, as specified under subsection a.; and "(3) provide justification that the Secretary has applied such regulation or order so as to protect from disclosure only the minimum amount of information necessary to protect the health and safety of the public or the common defense and security.". STANDARDS AND REQUIREMENTS UNDER SECTION 275

SEC. 18. (a) Section 275 of the Atomic Energy Act of 1954 is amended— (1) by striking in subsection a. "one year after the date of enactment of this section" and substituting "October 1, 1982" and by adding the following at the end thereof: "After October 1, 1982, if the Administrator has not promulgated standards in final form under this subsection, any action of the Secretary of Energy under title I of the Uranium Mill Tailings Radiation Control Act of 1978 which is required to comply with, or be taken in accordance with, standards of the Administrator shall comply with, or be taken in accordance with, the standards proposed by the Administrator under this subsection until such time as the Administrator promulgates such standards in final form."; (2) by striking in subsection b. (1) "eighteen months after the enactment of this section, the Administrator shall, by rule, promulgate" and inserting in lieu thereof the following: "October 31, 1982, the Administrator shall, by rule, propose, and within 11 months thereafter promulgate in final form,'; (3) by adding the following at the end of subsection b. (1): "If the Administrator fails to promulgate standards in final form under this subsection by October 1, 1983, the authority of the Administrator to promulgate such standards shall terminate, and the Commission may take actions under this Act without regard to any provision of this Act requiring such actions to comply with, or be taken in accordance with, standards promulgated by the Administrator. In any such case, the Commission shall promulgate, and from time to time revise, any such standards of general application which the Commission deems necessary to carry out its responsibilities in the conduct of its licensing activities under this Act. Requirements established by the Commission under this Act with respect to byproduct material as defined in section l i e. (2) shall conform to such standards. Any requirements adopted by the Commission respecting such byproduct material before promulgation by the Commission of such standards shall be amended as the Commission deems necessary to conform to such standards in the same manner as provided in subsection f. (3). Nothing in this subsection shall be construed to prohibit or suspend the implementation or enforcement by the Commission of any requirement of the Commission respecting byproduct material as defined in section 11 e. (2) pending promulgation by the Commission of any such standard of general application."; (4) by adding the following new subsection at the end thereof: "f. (1) Prior to January 1, 1983, the Commission shall not implement or enforce the provisions of the Uranium Mill Licensing Requirements published as final rules at 45 Federal Register 65521

42 USC 2022.

42 USC 7911.

Promulgation authority.

42 USC 2014.

Uranium mill licensing requirement regulations.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/716

 96 STAT. 2078 Implementation and enforcement.

Review, public comment, and suspension.

42 USC 2114.

Remedial action. 42 USC 7918.

Ante, p. 2077; post, p. 2080.

PUBLIC LAW 97-415—JAN. 4, 1983

to 65538 on October 3, 1980 (hereinafter in this subsection referred to as the 'October 3 regulations'). After December 31, 1982, the Commission is authorized to implement and enforce the provisions of such October 3 regulations (and any subsequent modifications or additions to such regulations which may be adopted by the Commission), except as otherwise provided in paragraphs (2) and (3) of this subsection. "(2) Following the proposal by the Administrator of standards under subsection b., the Commission shall review the October 3 regulations, and, not later than 90 days after the date of such proposal, suspend implementation and enforcement of any provision of such regulations which the Commission determines after notice and opportunity for public comment to require a major action or major commitment by licensees which would be unnecessary if— "(A) the standards proposed by the Administrator are promulgated in final form without modification, and "(B) the Commission's requirements are modified to conform to such standards. Such suspension shall terminate on the earlier of April 1, 1984 or the date on which the Commission amends the October 3 regulations to conform to final standards promulgated by the Administrator under subsection b. During the period of such suspension, the Commission shall continue to regulate byproduct material (as defined in section H e. (2)) under this Act on a licensee-by-licensee basis as the Commission deems necessary to protect public health, safety, and the environment. "(3) Not later than 6 months after the date on which the Administrator promulgates final standards pursuant to subsection b. of this section, the Commission shall, after notice and opportunity for public comment, amend the October 3 regulations, and adopt such modifications, as the Commission deems necessary to conform to such final standards of the Administrator. "(4) Nothing in this subsection may be construed as affecting the authority or responsibility of the Commission under section 84 to promulgate regulations to protect the public health and safety and the environment.". (b)(1) Section 108(a) of the Uranium Mill Tailings Radiation Control Act of 1978 is amended by adding the following new paragraph at the end thereof: "(3) Notwithstanding paragraphs (1) and (2) of this subsection, after October 31, 1982, if the Administrator has not promulgated standards under section 275 a. of the Atomic Energy Act of 1954 in final form by such date, remedial action taken by the Secretary under this title shall comply with the standards proposed by the Administrator under such section 275 a. until such time as the Administrator promulgates the standards in final form.". (2) The second sentence of section 108(a)(2) of the Uranium Mill Tailings Radiation Control Act of 1978 is repealed. AGREEMENT STATES

42 USC 2021.

42 USC 2014.

SEC. 19. (a) Section 274 o. of the Atomic Energy Act of 1954 is amended by adding the following at the end thereof: "In adopting requirements pursuant to paragraph (2) of this subsection with respect to sites at which ores are processed primarily for their source material content or which are used for the disposal of byproduct material as defined in section 11 e. (2), the State may

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96 STAT. 2079

adopt alternatives (including, where appropriate, site-specific alternatives) to the requirements adopted and enforced by the Commission for the same purpose if, after notice and opportunity for public hearing, the Commission determines that such alternatives will achieve a level of stabilization and containment of the sites concerned, and a level of protection for public health, safety, and the environment from radiological and nonradiological hazards associated with such sites, which is equivalent to, to the extent practicable, or more stringent than the level which would be achieved by standards and requirements adopted and enforced by the Commission for the same purpose and any final standards promulgated by the Administrator of the Environmental Protection Agency in accordance with section 275. Such alternative State requirements 42 USC 2022. may take into account local or regional conditions, including geology, topography, hydrology and meteorology.". (b) Section 204(h)(3) of the Uranium Mill Tailings Radiation Control Act of 1978 is amended by inserting the following before the 42 USC 2021 period at the end thereof: ": Provided, however, That, in the case of a ^°State which has exercised any authority under State law pursuant to an agreement entered into under section 274 of the Atomic Energy Act of 1954, the State authority over such byproduct 42 USC 2021. material may be terminated, and the Commission authority over such material may be exercised, only after compliance by the Commission with the same procedures as are applicable in the case of termination of agreements under section 274 j. of the Atomic Energy Act of 1954.". AMENDMENT TO SECTION 84

SEC. 20. Section 84 of the Atomic Energy Act of 1954 is amended by adding the following at the end thereof: "c. In the case of sites at which ores are processed primarily for their source material content or which are used for the disposal of byproduct material as defined in section l i e. (2), a licensee may propose alternatives to specific requirements adopted and enforced by the Commission under this Act. Such alternative proposals may take into account local or regional conditions, including geology, topography, hydrology and meteorology. The Commission may treat such alternatives as satisfying Commission requirements if the Commission determines that such alternatives will achieve a level of stabilization and containment of the sites concerned, and a level of protection for public health, safety, and the environment from radiological and nonradiological hazards associated with such sites, which is equivalent to, to the extent practicable, or more stringent than the level which would be achieved by standards and requirements adopted and enforced by the Commission for the same purpose and any final standards promulgated by the Administrator of the Environmental Protection Agency in accordance with section 275.".

Alternative f S s l S ^^ 42 USC 2114. 42 USC 2014.

42 USC 2022.

EDGEMONT

SEC. 21. Section 102(e) of the Uranium Mill Tailings Radiation Control Act of 1978 is amended by adding the following at the end thereof: "(3) The Secretary shall designate as a processing site within the meaning of section 101(6) any real property, or improvements thereon, in Edgemont, South Dakota, that—

42 USC 7912. 42 USC 7911.

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Page:United States Statutes at Large Volume 96 Part 2.djvu/718

 96 STAT. 2080

42 USC 7917.

PUBLIC LAW 97-415—JAN. 4, 1983 "(A) is in the vicinity of the Tennessee Valley Authority uranium mill site at Edgemont (but not including such site), and "(B) is determined by the Secretary to be contaminated with residual radioactive materials. In making the designation under this paragraph, the Secretary shall consult with the Administrator, the Commission and the State of South Dakota. The provisions of this title shall apply to the site so designated in the same manner and to the same extent as to the sites designated under subsection (a) except that, in applying such provisions to such site, any reference in this title to the date of the enactment of this Act shall be treated as a reference to the date of the enactment of this paragraph and in determining the State share under section 107 of the costs of remedial action, there shall be credited to the State, expenditures made by the State prior to the date of the enactment of this paragraph which the Secretary determines would have been made by the State or the United States in carrying out the requirements of this title.". ADDITIONAL AMENDMENTS TO SECTIONS 84 AND 275

42 USC 2114.

Ante, p. 2077.

SEC. 22. (a) Section 84 a. (1) of the Atomic Energy Act of 1954 is amended by inserting before the comma at the end thereof the following: ", taking into account the risk to the public health, safety, and the environment, with due consideration of the economic costs and such other factors as the Commission determines to be appropriate,". (b) Section 275 of the Atomic Energy Act of 1954 is amended— (1) in subsection a., by inserting after the second sentence thereof the following new sentence: "In establishing such standards, the Administrator shall consider the risk to the public health, safety, and the environment, the environmental and economic costs of applying such standards, and such other factors as the Administrator determines to be appropriate."; and (2) by adding at the end of subsection b. (1) the following new sentence: "In establishing such standards, the Administrator shall consider the risk to the public health, safety, and the environment, the environmental and economic costs of applying such standards, and such other factors as the Administrator determines to be appropriate.". URANIUM SUPPLY

eomprehensive industry review, submittal to Congress. 42 USC 2210b note.

SEC. 23. (a)(1) Not later than 12 months after the date of enactment of this section, the President shall prepare and submit to the Congress a comprehensive review of the status of the domestic uranium mining and milling industry. This review shall be made available to the appropriate committees of the United States Senate and the House of Representatives. (2) The Comprehensive review prepared for submission under paragraph (1) shall include— (A) projections of uranium requirements and inventories of domestic utilities; (B) present and future projected uranium production by the domestic mining and milling industry; (C) the present and future probable penetration of the domestic market by foreign imports;

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96 STAT. 2081

(D) the size of domestic and foreign ore reserves; (E) present and projected domestic uranium exploration expenditures and plans; (F) present and projected employment and capital investment in the uranium industry; (G) an estimate of the level of domestic uranium production necessary to ensure the viable existence of a domestic uranium industry and protection of national security interests; (H) an estimate of the percentage of domestic uranium demand which must be met by domestic uranium production through the year 2000 in order to ensure the level of domestic production estimated to be necessary under subparagraph (G); (I) a projection of domestic uranium production and uranium price levels which will be in effect both under current policy and in the event that foreign import restrictions were enacted by Congress in order to guarantee domestic production at the level estimated to be necessary under subparagraph (G); (J) the anticipated effect of spent nuclear fuel reprocessing on the demand for uranium; and (K) other information relevant to the consideration of restrictions on the importation of source material and special nuclear material from foreign sources. (b)(1) Chapter 14 of the Atomic Energy Act of 1954 is amended by adding the following new section at the end thereof: "SEC. 170B. URANIUM SUPPLY.—

"a. The Secretary of Energy shall monitor and for the years 1983 to 1992 report annually to the Congress and to the President a determination of the viability of the domestic uranium mining and milling industry and shall establish by rule, after public notice and in accordance with the requirements of section 181 of this Act, within 9 months of enactment of this section, specific criteria which shall be assessed in the annual reports on the domestic uranium industry's viability. The Secretary of Energy is authorized to issue regulations providing for the collection of such information as the Secretary of Energy deems necessary to carry out the monitoring and reporting requirements of this section. "b. Upon a satisfactory showing to the Secretary of Energy by any person that any information, or portion thereof obtained under this section, would, if made public, divulge proprietary information of such person, the Secretary shall not disclose such information and disclosure thereof shall be punishable under section 1905 of title 18, United States Code. "c. The criteria referred to in subsection a. shall also include, but not be limited to— "(1) an assessment of whether executed contracts or options for source material or special nuclear material will result in greater than 87*72 percent of actual or projected domestic uranium requirements for any two-consecutive-year period being supplied by source material or special nuclear material from foreign sources; "(2) projections of uranium requirements and inventories of domestic utilities for a 10 year period; "(3) present and probable future use of the domestic market by foreign imports; "(4) whether domestic economic reserves can supply all future needs for a future 10 year period;

Report to Congress and President. 42 USC 2210b. 42 USC 2231.

Regulations.

Proprietary information, disclosure.

Criteria.

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