ML20135B967

Forwards Final Amend to 10CFR20 & 35 Dealing W/Criteria for Release of Patients Administered Radioactive Matls

ML20135B967
Person / Time
Issue date:	01/28/1997
From:	Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA)
To:	Inhofe J, Schaefer D HOUSE OF REP., ENERGY & COMMERCE, SENATE, ENVIRONMENT & PUBLIC WORKS
Shared Package
ML20135B969	List: ML20135B967 ML20135B993
References
FRN-59FR30724, RULE-PR-20, RULE-PR-35 CCS, NUDOCS 9703030289
Download: ML20135B967 (2)

Text

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UNITED STATES j

g NUCLEAR REGULATORY COMMISSION g

waseemenm, o.c. sesswen i

j Jarnaary 28, 1997 The Honorable James Inhofe, Chatruan j

Subcommittee on Clean Air, Wetlands, Private i

Property and Iluclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510 l

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee is a final amendment to 10 l

CFR Parts to and 35 dealing with criteria for the release of patients administered radioactive materials. Roughly 8 to g million medical diagnostic and therapeutic administrations of radioactive material are performed in the United States each year.

i The rule is largely in response to three petitions for rulemaking that were submitted by the medical community because of concerns that the NRC's recent amendents of its regulations in Part 20, " Standards for Protection Against Radia', ion," would require medically unnecessary hospitalization of patients admir.istered radioactive materials for the treatment of disease and would thus increase national health care costs.

l The rule makes it clear that the release of patients administered radioactive materials continues to be regulated by the requirements in NRC's Part 35, j

' Medical Use of Byproduct Material." Thus, the more restrictive requirements i

in Part 20 do not apply to release of patients. While the comments of the j

medical community on the proposed rule were generally supportive, they j

objected strongly to one of the recordkeeping requirements contained in the proposed rule. Upon reconsideration, the NRC has deleted the recordkeeping i

requirement in question after concluding that the records were not necessary j

to provide for adequate protection of public health and safety.

f Sincerely, Sf.

Dennis K. Rathbun, Director j

Office of Congressional Affairs

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Enclosure:

l As Stated i

ec:

Senator Bob Graham

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uomTao STATES g

NUCLEAR REGULATORY COMMISSION j

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1 January 28, 1997 4

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i The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce l

United States House of Representatives l

Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee is a final amendment to 10 j

CFR Parts 20 and 35 dealing with criteria for the release of patients administered radioactive materials. Roughly 8 to 9 million medical diagnostic and therapeutic administrations of radioactive material are performed in the

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United States each year.

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The rule is largely in response to three petitions for rulemaking that were

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submitted by the medical community because of concerns that the NRC's recent i

j amendments of its regulations in Part 20 " Standards for Protection Against 1

i Radiation," would require medically unnecessary hospitalization of patients i

administered radioactive materials for the treatment of disease and would thus j

increase national health care costs.

l The rule makes it clear that the release of patients administered radioactive j

materials continues to be regulated by the requirements in NRC's Part 35, j

" Medical Use of Byproduct Material." Thus, the more restrictive requirements i

in Part 20 do not apply to release of patients. While the comments of the medical community on the proposed rule were generally supportive, they j

objected strongly to one of the recordkeeping requireevnts contained in the proposed rule. Upon reconsideration, the NRC has deleted the recordkeeping i

requirement in question after concluding that the records were not necessary j

to provide for adequate protection of public health and safety.

i j

Sincerely, I

h&fe

-m i

Dennis K. Rathbun, Director l

Office of Congressional Affairs

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Enclosure:

i As Stated j

cc:

Rep. Ralph Hall 1

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