NUREG-1492, Forwards Coversheets of Reg Guide 8.39, Release of Patients Administered Radioactive Matls & NUREG-1492, Regulatory Analysis on Criteria for Release of Patients.... Subj Reg Guide Is Not Major Rule as Defined in 5 U.S.C. 804(2)
| ML20148E510 | |
| Person / Time | |
|---|---|
| Issue date: | 04/16/1997 |
| From: | Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Gingrich N, Gore A, Murphy R GENERAL ACCOUNTING OFFICE, HOUSE OF REP., SPEAKER OF THE HOUSE, SENATE, PRESIDENT OF THE SENATE |
| References | |
| RTR-NUREG-1492, RTR-REGGD-08.039, RTR-REGGD-8.039 CCS, NUDOCS 9706030142 | |
| Download: ML20148E510 (5) | |
Text
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j "*4<.,,\ UNITED STATES g NUCLEAR HEGULATORY COMMISSION o WASHINGTON, D.C. 30006 4001
%,***** l April 16, 1997 l
I l
l The Honorable Al Gore l President of the United States Senate
, Washington, DC 20510
Dear Mr. President:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is l subcAtting Regulatory Guide 8.39, " Release of Patients Administered l Radioactive Materials."
)
Regulatory Guide 8.39 provides guidance on determining when licensees may authorize the release of patients who have been administered radiopharma-ceuticals e permanent implants containing radioactive material. The guide also provides guidance on instructions that may be necessary for such patients and on records that may be needed for such patients.
We have determined that this regulatory guide is not a " major rule" as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of Regulatory Guide 8.39, which will be distributed to affected licensees and other interested parties.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
Regulatory Guide 8.39 Regulatory Analysis
\
(g dMO 9706030142 9 ORG y6 i i PDR PDR
l
. l'%k UNITED STATES y# ) NUCLEAR REGULATORY COMMISSION
.s # WASHINGTON, D.C. asseMeet
- April 16, 1997 l
The Honorable Newt Gingrich l' Speaker of the United States House of Representatives Washington, DC 20515
Dear Mr. Speaker:
1 Pursuant to' Subtitle E of the Small Business Regulatory Enforcement Fairness I Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting Regulatory Guide 8.39, " Release of Patients Administered ;
Radioactive Materials."
Regulatory Guide 8.39 provides guidance on determining when licensees may authorize the release of patients who have been administered radiopharma-cauticals or permanent implants containing radioactive material. The guide also provides guidance on instructions that may be necessary for such patients and on records that may be needed for such patients.
We have determined that this regulatory guide is not a " major rule" as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of Regulatory Guide 8.39, which will be distributed to affected licensees and other interested parties.
Sincerely, i,
f Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
Regulatory Guide 8.39 Regulatory Analysis a
- - . . . - - . - . . - . - - . - - . - . . - . - - . _ - - - - . . - . . - - - . - . _ . ~ . . . _ _ .
\
[#,..aas%gS
[ UNITED STATES i
g
] NUCLEAR REGULATORY COMMISSION wasmmeron, o.c. senewam j g-b % ***** / April 16, 1997 i
l 1 i l Mr. Robert P. Murphy l General Counsel General Accounting Office l
!- Room 7175 I 441 G Street, NW.
I Washington, DC 20548
Dear Mr. Murphy:
l Pursuant'to Subtitle E of the Small Business Regulatory Enforcement Fairness l j Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is i
submitting Regulatory Guide 8.39, " Release of Patients Administered i Radioactive Materials." i i
Regulatory Guide 8.39 provides guidance on determining when licensees may authorize the release of patients who have been administered radiopharma- ,
i cauticals or permanent implants containing radioactive material. The guide !
l also provides guidance on instructions that may be necessary for such patients i l and on records that may be needed for such patients. I i .
j We have determined that this regulatory guide is not a " major rule" as defir.ed ,
- in 5 U.S.C. 804(2). We have confirmed this determination with the Office of I j Management.and Budget.
1 l
Enclosed is a copy of Regulatory Guide 8.39, which will be distributed to l affected licensees and other interested parties.
l Sincerely, bM Dennis K. Rathbun, Director l Office of Congressional Affairs i
Enclosures:
i Regulatory Guide 8.39 l Regulatory Analysis
I
- '. ==
U.S. NUCLEAR REGULATORY COMMISSlON April 1997 l
@**gf) ***
f OFFICE OF NUCLEAR R REGULATORY GUIDE 8.39 (Draft was DG-8015) i RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIALS l A. INTRODUCTION release, if the total effective dose equivalent is calcu-lated by (1) using the retained activity rather than the
, Section 35.75," Release ofIndividuals Containing activity administered, (2) using an occupancy factor Radiopharmaceuticals or Permanent Implants," in less than 0.25 at 1 meter, (3) using the biological or ef-
! 10 CFR Part 35," Medical Use of Byproduct Material,"
{ permits licensees to " authorize the release from its con-fective half life, or (4) considering the shielding by tissue."
i trol of any individual who has been administered radio-
- pharmaceuticals or permanent implants containing ra. In 10 CFR 35.75(d), the licensee is required to i dioactive material if the total effective dose equivalent " maintain a record, for 3 years after the dat? of release, to any other individual from exposure to the released in. that instructions were provided to a bre st-feeding
- dividual is not likely to exceed 5 millisieverts (0.5 woman if the radir. tion dose to the infant or child from
- rem)." continuedbreast feeding couldresultinatotaleffective Further,10 CFR 35.75(b) requires that the licensee dose equivalent exceeding 5 millisieverts (0.5 rem)."
i
" provide the released individual with instructions, in. In this guide, the individual to whom the radioac-cluding written instructions, on actions recomrhended tive material has been administered is called the i to maintain doses to other individuals as low as is rea. " patient."
sonably achievable if the total effective dose equivalent
. Ibis guide provides guidance to the licensee on to any other individual is likely to exceed 1 millisievert determining (1) when the licensee may authorize the (0.1 rem). If the dose to a breast feeding infant or child release of a patient who has been administered radio-could exceed 1 millisievert (0.1 rem) assuming there pharmaceuticals or permanent implants containing ra-were no interruption of breast feeding, the instructicas dioactive material, (2) when instructions to the patient shall also include (1) guidance on the interruption or are required by 10 CFR 35.75(b), and (3) when records discontinuation of breast feeding and (2) information are required by 10 CFR 35.75(c) and (d) to be generated on the consequences of failure to follow the guidance."
and maintained. The guide lists activities for common-In addition,10 CFR 35.75(c) requires that the li- ly used radionuclides and their corresponding dose censee " maintain a record of the basis for authorizing rates with which a patient may be released in com-the release of an individual, for 3 years after the date of pliance with the dose limits in 10 CFR 35.75.
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, . .. l NUREG-1492
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! Regulatory Analysis on Criteria l l for the Release of Patients !
l Administered Radioactive Material l Final Report U.S. Nuclear Regulatory Commission i
Office of Nuclear Regulatory Research S. Schneider, S. A. McGuire ps# "*%
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