ML20147D935

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Provides Info Re Final Amend to 10CFR20 & 35 Dealing W/ Criteria for Release of Patients Administered Radioactive Materials
ML20147D935
Person / Time
Issue date: 01/28/1997
From: Rathbun D
NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA)
To: Faircloth L, Inhofe J, Schaefer D
HOUSE OF REP., ENERGY & COMMERCE, SENATE, SENATE, ENVIRONMENT & PUBLIC WORKS
Shared Package
ML20147D933 List:
References
NUDOCS 9702180141
Download: ML20147D935 (8)


Text

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UNITED STATES NUCLEAR REGULATORY COMMIS810N

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  • t j ***** Jarnaary 28, 1997 i

i The Honorable James Inhofe, Chairman

Subcommittee on Clean Air, Wetlands, Private

! Property and Nuclear Safety Committee on Environment and Public Works i United States Senate

Washington, DC 20510 t

Dear Mr. Chairman:

Enclosed for the infonnation of the Subcosmittee is a final amendment to 10 CFR Parts 20 and 35 dealing with criteria for the release of patients j administered radioactive materials. Roughly 8 to 9 million medical diagnostic

. and therapeutic administrations of radi6 active material are performed in the j United States each year.

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 i amendments of its regulations in Part 20, " Standards for Protection Against Radiation," would require medically unnecessary hospitalization of patients

administered 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,
" Medical Use of Byproduct Material." Thus, the more restrictive requirements 4

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

requirement in question after concluding that the records were not necessary

! to provide for adequate protection of public health and safety.

l Sincerely, m$[/ y -

~

l Dennis K. Rathbun, Director i Office of Congressional Affairs 1

I

Enclosure:

j As Stated 3 cc: Senator Bob Graham

9702180141 970128
PDR ORG NREBRP i PM

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  • P; NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. seess ee01 y*****j' January 28, 1997 The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515 l

Dear Mr. Chairman:

i Enclosed for the information of the Subcommittee is a final amendment to 10 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 United States each year.

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 amendments of its regulations in Part 20 " Standards for Protection Against Radiation," would require medically ~ unnecessary hospitalization of patients administered radioactive materials for the treatment of disease and would thus increase national health care costs.

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,

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

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

medical community on the proposed rule were generally supportive, they objected strongly to one of the recordkeeping requirements contained in the proposed rule. Upon reconsideration, the NRC has deleted the recordkeeping requirement in question after concluding that the records were not necessary to provide for adequate protection of public health and safety.

Sincerely, p, M[ (L Director

~A Dennis Office ofK. Rathbun,ional Affairs Congress i ,

i

Enclosure:

As Stated

, cc: Rep. Ralph Hall i

l

The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515

Dear Congressman Schaefer:

Enclosed for the information of the Subcommitter are copies of a public 4

announcement and a final amendment to 10 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 United States each year.

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 1

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

, Radiation," would require medically unnecessary hospitalization of patients administered radioactive materials for the treatment of disease and would thus increase national health care costs.

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,

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

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 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 l to provide for adequate protection of public health and safety.

Sincerely, Dennis K. Rathbun, Director j Office of Congressional Affairs

Enclosures:

1. Public Announcement

~

2. Federal Register Notice cc: Rep. Frank Pallone Distribution: G:\SCHNEID\ RELEASE \CL.FRM CTrottier/RPHEB rf File Center NCostanzi
  • See previous conc ~

Office RPHEB:DRA RPHEB:DRA D:DRA:RES y -BHtESk )

Name SSchneider* CTrottier* BMorris* [ biforrish Date 1/17/97 1/17/97 1/17/97 1/ 2l /97 oistributi m Yes/No Yes/No Yes/No Yes/No Office OGC Name DRathbuer Date 1/ 2, /97 oistributim Yes/No l OFFICIAL RECORD COPY (File Code No.)3A-3 l 1

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[" . UNITED STATES g- g NUCLEAR REGULATORY COMMISSION

, o f WASHINGTON, D.C. 205f64001 k %j o k i.....s ,

The Honorable Dan Schaefer, Chairman ,

Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515

Dear ,

W... Af r f E b 4 W ,

m ......m r: j

, Enclosed for the information of the Subcommittee ar/e copies of a public announcement and a final amendment to 10 CFR Part's 20 and 35 dealing with criteria for the release of_ patients administer d radioactive materials.

Roughly 8 to 9 million medical ~ diagnostic and herapeutic administrations of radioactive material are performed in the U ted States each year.

4 The rule is largely in response to three titions for rulemaking-that were submittedbythemedicalcommunitybecaup6ofconcernsthattheNRC'srecent amendments of its regulations in Part 29, " Standards for Protection Against Radiation," would require medically unnecessary hospitalization of patients

] administered radioactive materials for/the treatment of disease and would thus 1 increase national health care costs.  !

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

" Medical Use of Byproduct Material'." Thus, the more restrictive requirements inPart20donotapplytoreleageofpatients. While the comments of the medical community on the proposed rule were generally supportive, they 4 objected strongly to one of the'recordkeeping requirements contained in the proposed rule. Upon reconsid ation, the NRC has deleted the recordkeeping requirement in question after concluding that the records were not necessary

~

, to provide for adequate prot tion of public health and safety.

Sincerely, 4

4 Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

1. Public Announcement
2. Federal Register' Notice cc: ".q . T n a u m ,efdAfw ,,7]sg/d.u zq/9 - 12pbJO D

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

. United States House of Representatives Washington, DC 20515

Dear Congressman Schaefer:

)

Enclosed for the information of the Subcopmittee are copies of a public announcement and a final amendment to 10 CFR Parts 20 and 35 dealing with criteria for the release of patients admini (ered radioactive materials.

Roughly 8 to 9 million medical diagnostic nd therapeutic administrations of l radioactive material are performed in t United States each year.  !

l The rule is largely in respons to three petitions for rulemaking that l were submitted by the medical commu ty because of concerns that the NRC's '

recent amendments of its regulati s in Part 20, " Standards for Protection Against Radiation," would requir medically unnecessary hospitalization of patients administered radioact e materials for the treatment of disease and would thus increase national ealth care costs. .

The rule makes it cl r that the release of patients administered radioactive materials con nues to be regulated by the requirements in NRC's  !

Part 35, " Medical Use of yproduct Material." Thus, the more restrictive  !

requirements in Part 20 do not apply to release of patients. While the l comments of the medic - community on the proposed rule were generally i

supportive, they obj ted strongly to one of the recordkeeping requirements contained in the pr osed rule. Upon reconsideration, the NRC has deleted the i recordkeeping requ ement in question after concluding that the records were not necessary to ovide for adequate protection of public health and safety.

Sincerely, I Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

1. Public Announcement
2. Federal Register Notice cc: Rep. Frank Pallone Distribution: G:\SCHNEID\ RELEASE \CL.FRM CTrottier/RPHEB rf File Center NCostanzi Office RPHEB:DRA, RPHEB:DRA /D:Dk k D:RES Name SSchneidd CTrottierb htb$is DMorrison Date I / (l'[97 l/d /97 //I1 /97 / /97 oistritutim Yes/No Yes/No Yes/h Yes/No Office OGC Name DRathbun Date / /97 Distributim Yes/No 0FFICIAL RECORD COPY (File Code No.)3A-3

f * *U ,

j fa' . A UNITED STATES g g NUCLEAR REGULATORY COMMISSION t WASHINGTON, D.C. 20555-0001

.....,o The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, j Private Property and Nuclear Safety i Committee on Environment and Public Works United States Senate Washington, DC 20510 ,-

/

Dear Congressman Faircloth:

Enclosed for the information of the Subcommittee a e copies of a public l announcement and a final amendment to 10 CFR Par 4 20 and 35 dealing with i criteria for the release of patients administer d radioactive materials. l Roughly 8 to 9 million medical diagnostic and herapeutic administrations of radioactive material are performed in the Un"ted States each year.

1 The rule is largely in response to three titions for rulemaking that were l 4

submitted by the medical community becaup6 of concerns that the NRC's recent amendments of its regulations in Part 20, " Standards for Protection Against Radiation," would require medically un cessary hospitalization of patients .

administered radioactive materials fo the treatment of disease and would thus  !

increase national health care costs. l The rule makes it clear that the re, ease of patients administered radioactive materials continues to be regulatef f"by the requirements in NRC's Part 35,

" Medical Use of Byproduct Materia . Thus, the more restrictive requirements in Part 20 do not apply to relea of patients'. While the comments of the 4

medical community on the propos rule were generally supportive, they objectedstronglytooneofthe/recordkeepingrequirementscontainedinthe proposed rule. Upon reconsideration, the NRC has deleted the recordkeeping requirement in question after oncluding that the records 'were not necessary  !

to provide for adequate prote tion of public health and safety.

i Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs l

Enclosures:

1. Public Announcement
2. Federal Register Notice ,

i a '

cc: Senator Bob Graham i

4

. .n - . - -. _. . _ . .. -

The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, I Private Property and Nuclear Safety Committee on Environment and Public Works United' States Senate Washington, DC 20510

Dear Congressman Faircloth:

Enclosed for the information of the Subcommittee are copies of a public l announcement and a final amendment to 10 CFR Parts 20 and 35 dealing with i 4

criteria for the release of patients administered radioactive materials. i Roughly 8 to 9 million medical diagnostic and therapeutic administrations of radioactive material are performed in the United States each year.

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 amendments of its regulations in Part 20, " Standards for Protection Against Radiation," would require medically unnecessary hospitalization of patients administered radioactive materials for the treatment of disease and would thus increase national health care costs.

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,

" Medical Use of Byproduct Material." Thus, the more restrictive requirements 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 objected strongly to one of the recordkeeping requirements contained in the proposed rule. Upon reconsideration, the NRC has deleted the recordkeeping requirement in question after concluding that the records were not necessary to provide for adequate protection of public health and safety.

Sincerely, 1

Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

1. Public Announcement l
2. Federal Register Notice cc: Senator Bob Graham i Distribution: G:\SCHNEID\ RELEASE \CL.FRM CTrottier/RPHEB rf File Center NCostanzi
  • See previous conc. . A Office RPHEB:DRA RPHEB:DRA D:DRA:RES ARN ]

Name SSchneider* CTrottier* BMorris* DMn Date 1/17/97 1/17/97 1/17/97 1/ 7) /97 oistribution Yes/No Yes/No Yes/No Yes/No unnummusumummanumu- sumimmuumunamunes-memanumm - - - - - - - - - - - -

Office OGC Name DRathbun Date 1/ /97 Distribution Yes/No 0FFICIAL RECORD COPY (File Code No.)3A-3

.. . - ~ _ - .. - - . .-

The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety

, Committee on Environment and Public Works

! United States Senate l Washington, DC 20510 l

Dear Congressman Faircloth:

/

Enclosed for the information of the Subcommi) ee are copios of a public l l announcement and a final amendment to 10 CFR Par !l 20 and 35 dealing with l criteria for the release of patients administer radioactive materials.

Roughly 8 to 9 million medical diagnostic and herapeutic administrations of l radioactive material are performed in the Un ed States each year.

l The rule is largely in response to t ree petitions for rulemaking that were submitted by the medical community cause of concerns that the NRC's l recent amendments of its regulations in art 20, " Standards for Protection  !

l Against Radiation," would require medi ally unnecessary hospitalization of l patients administered radioactive mat rials for the treatment of disease and l would thus increase national health are costs.

l The rule makes it clear that the release of patients administered radioactive materials continues t be regulated by the requirements in NRC's Part 35, " Medical Use of Byprodu Materi al . " Thus, the more restrictive l

requirements in Part 20 do not ply to release of patients. While the t.omments of the medical communi y on the proposed rule were generally supportive, they objected stro gly to one of the recordkeeping requirements contained in the proposed rul . Upon reconsideration, the NRC has deleted the recordkeeping requirement in question after concluding that the records were not necessary to provide for adequate protection of public health and safety.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs .

Enclosures:

i

1. Public Announcement l
2. Federal Register Notice cc: Senator Bob Graham Distribution: G:\SCHNEID\ RELEASE \CL.FRM CTrottier/RPHEB rf File Center NCostanzi ,

Office RPHEB:CRA,%- RPHEB:DRA , D:D N S D:RES Name SSchneideb/,

+

CTrottied M is g

DMorrison Date

{ / '] /97 / / ll /97 l/ 11 /97 / /97 oistribution Yes/No Yes/No Yes/ o Yes/No immmmmmmmmmmmmmeimassimamammessuemmum . . . - - - - =.

Office OGC Name DRathbun l

Date / /97 Distribution Yes/No 0FFICIAL RECORD COPY (File Code No.)3A-3

. . -