ML20126A978

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Responds to Request for Views on Encl H.R.5934, Consumer- Patient Radiation Health & Safety Act of 1979. Bill Alters Regulatory Responsibilities Re Public Health & Safety. Commission Does Not Support Bill as Drafted.Draft Ltr Encl
ML20126A978
Person / Time
Issue date: 02/07/1980
From: Ahearne J
NRC COMMISSION (OCM)
To: Staggers H
HOUSE OF REP., INTERSTATE & FOREIGN COMMERCE
Shared Package
ML20126A980 List:
References
NUDOCS 8002290013
Download: ML20126A978 (20)


Text

7 %* UNITED STATES 4

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f U February 7,1980 CHAIRMAN The Honorable Harley 0. Staggers, Chairman -

Committee on Interstate and Foreign Commerce United States House of Representativas Washington, D.C. 20515

Dear Mr. Chairman:

This letter responds to your request for the Nuclear Regulatory Commission's views on H.R. 5934, the " Consumer-Patient Radiation Health and Safety Act of 1979." The NRC endorses the aim of this legislation to minimize expo-sure of consumer-patients to potentially hazardous radiation, but we be-lieve the bill, as drafted, contains serious weaknesses.

For example, Section 102(e) states a finding that "the protection of public health and safety from unnecessary consumer-patient exposure to potentially hazardous radiation from all sources is the primary responsibility of State and local government. . . ." We note that the Atomic Energy Act has vested in the Nuclear Regulatory Commission, rather than State or local governments, the primary responsibility for regulating the use of radioactive byproduct materials, which are a major source of radiation for medical purposes. In a recent policy statement the NRC stated its intention to " continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public." 44 Fed. Reg. 8242 (February 9,1979). This regulatory position was not questioned by any of the commenters on the draft policy statement but rather was consistently recognized as a necessary role in the medical uses of radioisotopes.

Consequently, we would not support legislation that does not recognize NRC's regulatory role in this regard.

As another significant alteration of present regulatory responsibilities, Section 121(d) of H.R. 5934 would transfer from the Enviromental protec-

t. ion Agency'to the Secretary of Health, Education and Welfare the authority to develop Federal radiation guidance with respect to all radiation matters

' directly or indirectly affecting health, including formulation of environ-mental radiation standards. This transfer of authority is not limited to matters of consumer-patient radiation therapy hazards and goes well beyond the needs addressed by the bill. It would contradict recommendations for a reconstitution of a Federal Council on radiation similar to the previous Federal Radiation Council made in recent congressional evaluations and by the Federal Task Force on the Health Effects of Ionizing Radiation

("Libassi Report"), Such a change would fragment the Federal program to regulate the hazards of ionizing radiation.

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The Honorable Harley O. Staggers Turning _to matters of detail in H.R. 5934, we have the following comments:

1. Section 131(a) requires the Secretary to promulgate voluntary

' minimum standards for the accreditation of educational institutions conducting education programs in radiologic services. Section

, 132(a) requires the Secretary to promulgate voluntary minimum standards for licensure of radiologic technologists. Section 141 makes compliance with all such standards mandatory on all Federal agencies. These standards are likely to substantially affect a large number of NRC licensees and man.y Federal agencies. Hence we believe it would be essential to include in any such bill a requirement that standards developed pursuant to Sections

, 131 or 132 shall be promulgated only after prior consultation ,

and coordination with the Nuclear Regulatory Commission.

2. Section 104(5) defines " radiologic technologist," for purposes of the Act, as "any person, other than a medical or dental practitioner, who administers radiation to consumer-patients,"

and further enumerates several categories of radiologic technologists.

Frequently in radiation therapy a radiation physicist acting on a prescription by~a physician, directly supervises the administration of radiation to the patient by the radiation technologist, but does not himself administer it. Thus following the word " administers," the words "or directly supervises the administration of," should be inserted to provide for the qualification of such persons.

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3. Section 121(b) enumerates categories of criteria and guidelines to be promulgated by the Secretary (HEW). Diagnostic nuclear medicine is not included. We believe that diagnostic nuclear medicine thould te included under any such guidelines and that the categories in Section 121(b) should be changed to read as follows:

"(1) the application of diagnostic X-rays to consumer-patients;

"(2) the administration of radioactive drugs for diagnostic

. purposes to consumer-patients;

"(3) the therapeutic external application of beam radiation to '

consumer-patients for treatment of disease; and

"(4) the therapeutic internal application of radiation to consumer-patients for treatment of disease, such as therapeutic nuclear

medicine applications." .

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The Honorable Harley Staggers Coninissioners Gilinsky and Bradford have expressed the following separate views regarding H.R. 5934:

We endorse the objective of minimizing the exposure of consumer-patients to potentially hazardous radiation. While the Nuclear Regulatory Congnission may be the appropriate agency to regulate the machinery and materials employed in nuclear medicine, it is not clear that it is the agency most competent to regulate the substance of the treatment or to license those administering such treatments. We endorse the coninents made in the paragraphs numbered 1, 2, and 3, above.

For reasons discusseo above and because of the many changes in detail which we believe are notessary before H.R. 5934 could be developed into a satisfactory piece af legislation, a majority of the ,Coninission does not support the bill as currently drafted. Thank you for giving us the opportunity to comment.

Sin,cerely, J hn F. Ahearne 1

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    • ,,4 CHAIRMAN The Honorable Harley O. Staggers Chairman, Committee on Interstate I and Foreign Commerce l United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

This letter responds to your recuest for the Nuclear Reculatory Commission's  :

views on H.R. 5934, the " Consumer-Patient Radiation Health and Safety Act I of 1979." ine NRC endorses the aim of this legislation to minimize expo- l sure of consumer-patients to potentially ha:ardous radiation, but we be-  !

liev.e the bill, as drafted, contains serious weaknesses.  !

For example, Section 102(e) states a finding that "the protection of public  !

nealth and se#ety from unnecessary consurer-patient exposure to potentially l ha:ardous raciation from all sources is the pric.arj responsibility of State a nd local government. . . . " We note that the Atomic Energy Act has vested in t'e ?; clear Regulatory Commission, rather than State or local covernments, the prirary responsibility for regulating the use of radioactive byproduct aterials, which are a major source of radiation for medical purposes. In  !

a recect policy statenent the NRC stated its intention to " continue to i regulate the medical uses of radioisotcpss as necessary to provide for the l radiat ce sa'ety of workers and the ceneral oublic." 44 Fed. Rec. E242

( Fe br;2 ry 9,1979) . This regulatory positien was not cuestionec by any of One co- enters on the draf t policy state ent but rather was consistently recc;ni:6d as a necessary rcle in tne nedical uses c# rad' isotopes.

Ccrsecuently, we would nct support legislation tcat does not recogni:e NRC's re;.iatory role in this recard.

As enother si;nificant alteration of present ree;latcry resoonsibilities, Section 121(d) of .R. 5934 would transe er from the Environ.nental Protec-tion *;er.cy to the Secretary cf Health, Education, and '.-l elf are the authority to de. ele: Federal radiation cuicance wita respe: to all radiation natters dire:tly :r indirectly affecting health, including forrulation of environ-

~entai radiation standards. This transfer cf authority is nct limited to natters of consumer-patient radiation therapy ha:ards and coes well beyond the needs addressed by the bill. It would contradict recommendations for a ,

reccostitution of the Federal Radiation Council made in recent congres- I sional evaluations and by the Federal Task Force on the Health Effects of i Ionizin; Radiation ("Libassi Report"). The NRC views such a change as an l undesirable fragmentation of the Federal oro.: ram to reculate the hazards of

. I ionizin; radiation.

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i g The Honorable Harley O. Staggers < 2 Turning to' matters of detail in' H.R. 5934, we have the following comments:

'1. Section 131(a) requires the Secretary to promulgate voluntary minimum standards for the accreditation of educational institutions conducting education programs in radiologic services. Section 132(a) requires the Secretary to promulgate voluntary minimum standards for licensure of radiologic technologists. Section 141 makes compliance with all such standards mandatory on all Federal agencies. These standards are likely to substantially affect a large number of URC licensees and many Federal agencies. Hence we believe it would be essential to include in'any such bill a recuirement that standards developed pur-suant to Sections 131 or 132 shall be promulgated only af ter prior consultation and coordination with the Nuclear Regulatory Commission.

2. Section 104(5) defines " radiologic technologist," for purposes of the

.Act, as "any person, other than a medical or dental practitioner, who administers radiation to consumer-patients," and further enumerates several categories of radiologic technologists. Frequently in radia-tion therapy a radiation physicist, actine on a prescription by a physician, directly supervises the administration of radiation to the patient by the radiation technologist, but does not himself administer it. Tnus following the word " administers," the words "or directly supervises the administration of," should be inserted to provide for the cualific6 tion of such persons.

3. Section 121(b) enunerates categories of criteria and guidelines to be crow 1 gated by the Secretary (KDl). Diacnostic nuclear medicine is not included. We believe that ciacnostic nuclear medicine should be included under any such guidelines and t5at the categories in Sec-tion 121(b) should be changed to read as follows:

"(1) tne application of diagnostic X-rafs to consumer-patients;

"(2) toe Edninistration of radioactive cru;5 fo diagnostic purposes to consumer-patients ;

"(3) the therapeutic external a?Diitation of bear radiaticn to consu .cr-catients for treatment of disease; and

"(4) the therapeutic internal applicction c' rsdiation to consu er-patients for treatment of disease, such as 19erapeutic nuclear

. medicine applications."

For reasons discussed ab0ve and because cf tne many changes in cetail which we believe are necessary before H.R. 5934 could be developec in.o a satis-f actory piece of legislation, NRC does not support this bili. Thank you for giving us the opportunity to comment.

Sincerely, John F. Pearne

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- 0 A To provide for the protection of the public health (including consumer patients)

- from unnecessary exposure to radiation.

t-IN THE HOUSE OF REPRESENTAT1TES NorrMBEE 16,19 9  ;-

Mr. Lrs; introduced the following bill: which was referred to the Committee on Interstate and Foreign Commerce e

A BILL U 1

To provide for the protection of the public health (including l consumer patients) f om unnecessary exposure to radiation.

1 Be it enacted by the Senate and Housc of Representa- ,

2 lit'cs of the Unitcd States of.4 merica in Congress assembled.

3 SHORT TITLE i 4 SEc.101. This Act may be cited as the " Consumer-5 Patient Radiation Health and Safety Act of 1979".

T.GLE OF CONTENTS pan; I-GrNIF.At. PROV SIONS Sec.101. Shon itle.

See.100. Findings.

Sec.103. Statement of purposes Sec.104. Definitions.

2 TABLE OF CONTENTS-Con:inued PART U-FEDERAL RAcrATioN PaoTEcTjoN GtnoEuNEs Sec.121. Promulgation of ra6ation protection guidelines.

PART C-DEPARTMINT OF EIALTH, EDUCATION, AND WELFARE Sec.131. Recommended minimum ra6ation protection standr.rds for accreditation.

Sec.132. Recommended minimum standards for licensure of ra6ologic t.echnolo.

gists.

Sec.133. State assistance.

Sec.134. Grants to educational ins:itutions.

Sec.135. Grants to certification organi:ations.

Sec.136. State Program Grams.

PART IV-FEDEEA:. ACTDmES Sec.141. Federal agency compliance.

Sec.142. Federa! arsistance preg ams. t i

PAET Y-ADW}STRATION t

Sec.151. AdtniniFtrati\ e procedures.

Sec.1 2. consultation.

PART U-APPROFELATIONS AUTHoE1:ATJoss .'

Sec.102. Authori::: ion of approp-ia: ions.

1 FINDINGS 2 Src.102. The Congress finds that-S (a) it is in the interest of the Nation's public 4 health and safety to minimize exposure of consumer-5 patients to potentially hazardous radiation:

G fo) while the use of radiologic procedures is essen-tlal in modern medicine, even the most advanced pro-i S cedures will not adeouately protect the health and [

9 safety of either the consumer-patient subjected to ra-i 10 diologic procedures or the individuals performing such l 11 radiologic procedures, inchiding their progeny. unless i

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the indhiduals performing such radiologic procedures s

2 are fully qualified by reason of education and experi- '

3 ence in the operation of radiologic equipment or in the '

4 performance of radiologic procedures so as to avoid un- .

o' necessary consumer-patient and operator exposure to 6 .. unnecessary radiation and to assure efficacious 7

consumer-patient radiologic services; S

(c) it is in the interest of public health to have an i" 9

adequate and continuing supply of well-educated radio-r -

10 logic technologists; II - E (d) consistent with Federal radiation protection 12 guidance for diagnostic X-rays approved by the Presi-

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23 dent on January 26,1975, it is in the national interest - -

14 and in the interest of public health and safety to assure 15 that persons administering potentially hazardous radi- .

16 ation to consumer-patients are properly qualified as has 17 been recommended bv- .

15 (1) the National Advisory Committee on Ra-19 diation to the Surgeon General in 1966:

20 (2) the Secretary's Task Force on Environ-21 mental Health and Related Problems in June 22 1967; 23 (3) the Surgeon General's Medical X-ray Ad-24 visory Committee on Public Health Consider- i i

4 1- ations in Medical Diagnostic Radiology in October 2 1967; 3 (4) the 1970 report of the Secretarv to the -

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4 Congress pursuant to the Radiation Control for s s.,

5 Heahh and Safety Act of 1968;

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d- G (5) the National Academy of Sciences-Na- sg i -4. .7 tional Research CounciPs Advisory Committee on t;!

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.,. ..- S the Biological Effects of Ionizing Radiations in S 4

., 3 9 November 1972; and - 'J iJ.

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10 (6) the Conference of Radiation Control Pro-  ;

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12 (e) that the protection of the public health and I\ $ p $

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safety from unnecessary consumer-patient exposure to [ -

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Os j 15 primar.v res.ponsibilit.y... , _. _of State and local covernment: - -

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17 (f) any person who prescribes or a6ninisters ra-IS diologic procedures to consumer-patients, including at 19 Federal facilities, should be required to demonstrate 20

'-[ competence by reason of education. experience, and ex-9' 21 amination, j 1 22 STATEMENT OF PURPOSES 23 SEc.103. The purposes of this Act, which shall be car- l 24 ried out consistent with the maximum protection of public f,

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1 health from unnecessary consumer-patient exposare to radi. A 2 ation, are to-1 3 $

(a) provide for the establishment of criteria and #

4 I guidelines for the credentialing or licensure of all per-5 p:o sonnel administering radiation to consumer-patients; 6

(b) provide for the establishment of criteria and

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n guidelines for use in accrediting programs for the edu-8 cation cf radiologic technologists; 9

(c) provide for the formulation of criteria and 10 guidelines applicable to all Federal agencies in the (1) 11 establishment and execution of consumer-patient radi- 3 12 x ation protecticn programs and (2) formulation of con-

  • Ce 13 sumer-patient radiation protection standards; 14 ,

(d) insure that all Federal agencies a6ninister 15 programs carried out or funded by such agencies so as

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16 to further the purposes of this Act; and '

17 (e) encourage State adoption and administration of

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for the education of radiologic technologists and for the U

20 licensure of radiologic technologists.

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o1 DEFINITIONS d f,_ .

22 e SEc.104. Unless otherwise expressly provided, for the R 23 purposes of this Act the term- 9 n'.;

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(1) " Administrator" means the Administrator of ^

25 ti e Environmental Protection Agency; +.c

.g 1- (2) " dental prac'titioners" means licensable doctors 2 of dentistry, who do or will prescribe or administer ra-3- diation to consumer-patients; 4 (3) " medical practitioners" means licensable doc-5 tors of medicine, osteopathy, podiatric medicine, or

. 6 chiropractic, who do or will prescribe or administer ra-7 diation to consumer patients or for specified limited S procedures, postgraduate physician trainees, such as .

9 interns and residents; i 10 (4) " radiation" means ionizing and nonionizing ra- . -

i 11 diation from such sources as consumer and commercial l 12 products, medical and dental radiation (including ding-

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13 nostic X rays), and natural radiation; 14 (5) " radiologic technologist" means any person.

15 other than a. medical or dental practitioner, who ad-16 ministers radiation to consumer-patients and includes, 17 but is not limited to, medical radiologic technologists 15 (including radiographers), dental radiologic technolo-19 gists (including demal hygienists and dental assistants).

20 radiation therapy technologists, and nuclear medicine 21 technologists; and  ;

22 (6) " Secretary" means the Secretary of Heahh, I:

23 Education, and Welfare, i I

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PART Il-FEDERAL RADIaTios PROTECTION 2 ,

GmDEuNES 3

PROMULGATION OF RA_DIATION PROTECTION GUIDELINES '.

4 SEc.121. (a)(1) The Secretary shall promulgate Feder- '

t 5 al radiation guidance with respect to consumer-patient radi-G ation matters directly or indirectly affecting public health. ~

7 Such guidance shall contain information regarding (A) the

  • i S sources of consumer patient radiation exposure and G) tech-O niques, procedures and methods to minimize unnecessary and 10 nonefficacious cor..;umer-patient radiation exposure. 1 11 \

(2) Pursuant to paragraph (1), the Secretary shall, in 12 consultation with affected Federal agencies, promulgate 13 guidelines regarding medical and dental exposure to consum. .

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er-patients. Such guidelines shall be in a form so as to (At l 15 facilitate the establishment of optimum techniques to mini-16 mize consumer-patient exposures, G) eliminate inconsistenev li and the resuhant need for retakes of diagnostic radiol $cic 15 procedures, (C) eliminate unproductive screening programs:

19 and (D) obtain the optimum diagnostic information with mini-1 20 mum consumer-patient exposure.

21 i (b) Within eighteen months of enactmem, the Secretary 'C I:4; 22 shall promulgate criteria and guidelines with respect to-23 j{

(1) the application of diagnostic X-rays to con- J 24 sumer-patients:

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.%.. b-& a 14 STANDARDS FOR ACCREDITATION 15 SEc.131. (a) Not later than December 31,1950, the N NSM Gr.g$$e.Ec

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10 1 nologists, technologist-in-training, and students in radiologic 2 technology.

3 (b)(1) The Secretary shall, within one year after promul-4 gation of voluntary minimum standards under this section, 5 review and evaluate any voluntary certification programs or G State licensure programs in existence as of such date and, 7 based on such review and evaluation, determine whether 8 such programs meet such standards.

9 (2) If the Secretary is satisfied that the program meets 10 such standards he shall. within one year thereafter, certify 11 such programs as in conformance with such standards.

12 (c) The Secretary shall review and, as appropriate. re-13 vise the standards promulgated by him pursuant to this sec-14 tion.

15 STATE ASSISTANCE 16 Szc.133. The Secretary shall provide the States such 17 advice and assistance as will foster esta?.lishmem of appropri-18 ate programs to achieve the purposes of this Act. Such ad-19 vice and assistance shall include model laws and may include 20 educational curriculum and teaching aids. Such model law 21 shall provide that-22 (a) graduation from an educational institution for 23 the education of radiologic technologists which is ac-24 Credited as in conformance with the volumary stand-26 STds promu} gated pursuant to section 181 shal} sStisfy

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1 (the requirements for a provisional license as a tech- i; i-2- nologists-in-training conditioned on licensure within "..

3 one year in one or more categories of specialization the 4 Secretary may designate; g

5 (b) it shall be unlawful for an individual to apply G potentially hazardous radiation to consumer-patient.;

7 unless such individual is a medical or dental practition-t S

i er or meets the standards promulgated pursuant to see- '

9 tion 182; and '

10 (c) if adopted by the State any violation of the i 11 model law by an individual applying potentially hazard- '

12 ous radiation to consumer-patients shall be subject to a 13 civil penalty of not more than $1,000. and any such .

14 violation shall be with respect to each Act or omission 15 made unlawfui by such law.

16 GRANTS TO EDUCATIONAL INSTITl'TIONS 17 SEC.134. The Secretar:. may, under title UI of the IS Public Health Senice Act, make grants to educational pro-19 grams accredited pursuant to section 131 to carry out the 20 purposes of this Act.

21

- GRANTS TO CERTIFICATION ORGANIZATIONS 22 SEC.135. The Secretary may make grants to States or 23 professional organizations designated pursuant to section 24 181th)in an amount up to 6624 per centum of the cost of the 25 first year and up to 33% per centum of the cost of the see-

sgu u -

12 1

ond, third, and fourth years for the planning, development, 2 and establishment of programs to carry out the purposes of 3 this Act.

4 STATE PROGRAM GRANTS 5

SEc.136. (a) The Secretary may, in accordance with 6 subsections (b) and (c), make grants to State radiation protec-7 tion agencies up to 50 per centum of the costs of programs 8 which the Secretary determines are consistent uith the pur- t 9 poses of this Act. Such grants shall provide for the accredita-10 tion of educational programs and for the mandatory licensure  !

11 of radiologic technologists. r 1 12 (b) Within six months of the issuance of any criteria and J 13 minimum standards pursuant to section 131 for the accredita-14 tion of educational programs, the Governor of a State may 15 file with the Secretary a letter of intent that such State will, I l

IG within two years of the issuance of such criteria and mini-17 mum standards. adopt as a minimum such criteria and stand-18 ards for the accreditation of such educational programs. If.

19 after two years, a State fails to adopt such standards. or is 20 unable to adopt such standards or more stringent standards, 21 eligibility for grants pursuant to this section shall terminate: 1 I

22 Provided, hotccrer, That upon application of a Governor, the i i

23 Secretary may grant an extension for not more than two '

i 24 years if after resiew the Secretary determines that good faith '

25 efforts have been made by the State and reasonable assur-

.  : l l

l 13 l 1 ance is provided that an effective accreditation program will i 2 be presided by the State within the period of the extension.

4 3 (c)(1) Within six months of the issuance of any criteria 4 and minimum standards issued pursuant to section 132 for 5 the licensure of radiologic technologists, the Governor _ of a t

6 State may file a letter of intent that such State will, within 7 two years of the issuance of such criteria and minimal stand-

)t 5

6 ards, adopt as minimum standards for such criteria and the

/

9 licensure of radiologic technologists. If after two years. a 10 Governor fails to adopt such standards, or is unable to adont '

11 such standards or more stringent standards. eligibility for j 12 grants pursuant to this subsection shall terminate: Provided. -

13 horerer, That upon application of a Governor, the Secretarr 14 may grant an extension for not more than !Wo years if arter 15 resiew the Secretary determines that good faith efforts have 16 been made by the State and reasonable assurance is provided 17 that an effective licensure program will be provided by the 15 State within the period of the extension.

19 (d) Notuithstanding any other provision of this section.

20 in the case of a State which has, prior to the effective daie of r 21 standards and guidelines promulgated pursuant to this sub- i r'

22 part, established standards for the accreditation of education-

+

23 al programs or licensure of radiologic technologists such I 24 State shall be deemed to be in compliance with the conditions  !

25 of this section unless the Secretary determines after notice l t

o 14 I

and hearing, that such State standards do not meet the mini-2 mum standards prescribed by the Secretary or are inconsist-8 ent with the purposes of this Act.

4 PART IV-FEDERAL ACTIVITIES

~

O FEDERAL AGENCY C-OMPLIANCE 6

SEC.141. Each department, agency, and instrumentali-7 ty of the executive branch of the Federal Government shall S comply with any minimum standards promulgated pursuant 9 to this Act.

1C .

FEDERAL ASSISTANCE PROGRAMS 11 SEC.142. (a) In order to carrv s., the purposes of this 12 Act the President shall, not later than one year after the 13 date of enactment. issue an Executive order recuiring each 14 Federal agency which is authorized to extend Federal assist.

15 ante or reimbursement of funds by men:, of grants. loans.

16 contracts. or other forms of financial assistance or reimburse-17 ment to pror.ptiv effectuate the purposes of in.s Act inch:d-is ing the adoption of minimum standards pro:nu! gated pursuant 19 to thiS Act.

20 fb) The President may bv order exempt any speci!!c 21 gram, loan. contract, or other form of fir.ancial assistance 22 from the requirements of this subsection if he determines i

23 such exemption is in the national interest The President  !

24 shall notify the Congress in writing of such exemption at '

25 least ninety days before it is effective.

l.

15 1 PART T-ADMINISTRATION

-2 SEC.151. Guidelines and standards prescribed under 3 this Act shall be promulgated by rule in accordance with the ..;

4 procedures set forth in section 553 of title 5, United States 5 Code.

G. CONSULTATION .,

7 SEc. 152. In establishing guidelines and minimum ,

' f..

S standards under this Act the Secretary shall consult with the i-Si Environmental Protection Agency, State health departments, ,

10 and appropriate professional organizations.

11 PART VI-APPROPRIATIONS ATJTHORIZATION 12 SEC.161. There is authorized to be appropriated to the '

1.

13 Secretary such sums as necessary to carry out the purposes 14 of this Act.

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