ML20238A018
| ML20238A018 | |
| Person / Time | |
|---|---|
| Issue date: | 07/06/1987 |
| From: | Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20237L662 | List: |
| References | |
| FRN-52FR27782, RULE-PR-30, RULE-PR-32 AB34-2-08, AB34-2-8, NUDOCS 8708280274 | |
| Download: ML20238A018 (2) | |
Text
2 J
AB34-2 PDR i
JUL 0 61987 MEMORANDUM FOR: Victor Stello, Jr. '
l Executive Director for Operations FROM: Hugh L. Thompson, Jr., Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
FINAL AMENCMENTS TO 10 CFR PARTS 30 AND 32 - MANUFACTURERS' REGISTRATION OF SAFETY INFORMATION ON RADIATION SOURCES AND DEVICES - !
Enclosed for your signature is a final rule which amends 10 CFR Parts 30 and 32 j to provide for manufacturers' registration of radiation safety information I about sources and devices containing radioactive material. l This rulemaking establishes regulations that clearly provide for the long- ,
standing practice whereby manufacturers of sealed sources of radioactive l
- material and devices containing sealed sources file radiation safety information l- about their products with the NRC. The information is evaluated and, when
- referenced in specific license applications by the manufacturers' customers, l used by the NRC and the Agreement States in determining that an applicant's proposed equipment and facilities are adequate to protect health and minimize q danger to life or property. 1 This practice is currently con' ducted under a g3neral provision in the regulations l that allows an applicant for specific license to incorporate, by reference in an l
application, information contained in previous reports filed with the Commission.
i The practice is extensively used. The NRC-maintained sealed source and device I registry centains information on approximately 3,000 models of sources and devices from about 400 manufacturers and distributors (vendors). Both the NRC and the 29 Agreement State licensing groups contribute data to and use the registry.
The final rule assures that vendors of sealed sources and devices are informed I of this practice and clearly states that manufacturers registering their i products with the NRC have a responsibility to ensure that the distributed I products meet the radiation safety-related specifications filed with the registry.
After your approval on January 9,1987, the proposed amendment in this rulemaking proceeding was published in the Federal Register for public comment.
We receivec nine letters of comment. Five letters were from regulatory agencies in Agreement States and all support issuance of the enclosed final rule. One letter from a trade association and two letters from manufacturers support the rule. A third manufacturer expressed a need for clarification of what radio-active sources were to be covered by the rule. This clarification is provided in the preamble of the final rule. The text of the final rule is substantially the same as the text of the propcsed amendment.
gB2 274 870820 30 62FR27782 PDR L -- _ _ _ _ _ __ _ - _ - _ _ _ _ _ _ _ . - - _ _ _ - .~ - - ,
Victor Stello, Jr. 2 JUL 0 s 1987 l
i i I recommend that you sign [under authority delegated in 10 CFR 1.40(c) and (d)]
the enclosed final rule that will amend 10 CFR Parts 30 and 32. The appropriate Congressional Committees will be informed of this final rule. A notice to the .
Commission that you have approved this final rule is enclosed for inclusion in the next Daily Staff Notes.
Coordination: The Offices of Nuclear Regulatory Research, Governmental and Public Affairs, Administration and Resources Management, and the General Counsel concur in the enclosed final amendments to 10 CFR Parts 30 and 32. The Office of Governmental and Public Affairs also concurs that a public announcement need '
not be issued.
(Signed) Robert M. Bernam q Hugh L. Thcmpson, Jr., Director Js Office of Nuclear Material Safety
'snd Safeguards
Enclosures:
- 1. Approval for Publication
- 2. FR Notice of Final Rulemaking ,
l 3. Regulatory Analysis
- 4. Draft Congressional Letter
- 5. Draft Daily Staff Notes Item DISTRIBUTION FCMA Central File RECunningham ARM NMSS r/f SCorne11 GPA FCAB r/f CSeeling 6 NMSS office r/f
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OFFICIAL RECORD COPY
- Memo attached.
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,(pa nto jo,, UNITED STATES y ) ,.i( g NUCLEAR REGULATORY COMMISSION
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June 11, 1987 l l
MEMORANDUM FOR: H gh Thompson, Director, NMSS L '
FROM: raMng_rinT,' A sisii6n1 to the Director of PA, GPA
SUBJECT:
AMENDMENT OF PARTS 30 and 32 !
The Office of Governmental and Public Affairs /PA concurs in the recommendation that no public announcement of the amendment to Parts 30 and 32 is required.
This conclusion is based on the fact that the amendment, which provides for pre-marketing rediation safety evaluations and registration of sealed sources and l
devices used under specific license, simply codifies long-standing administra-tive practice. j i
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'.,','.." Ref: SA/ LAB Jul 1 2 1937 l
l MEMORANDUM FOR: Hugh L. Thompson, Jr. , Director Office of Nuclear Material Safety and Safeguards FROM: Harold R. Denton, Director / l Office of Governmental and P 11c A fairs %
SUBJECT:
AMENDPENT OF 10 CFR PARTS 30 and 32 f
1 We have reviewed the subject document regarding premarketing radiation I safety evaluation and registration of sealed sources and devices to be used under specific license.
'rle concur and would like to offer the following coment:
Referance to the number of Agreement States should be changed to
- 29. 4 cc: J. Bradburne, CA J. Fouchard, Po. 1 J. Shea, IP i C. Kammerer, SLITP i
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NOTE: As recommended, the ?
number of Agreement {
States h4s.bcen changed :
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to 29.
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/ a)N 2 21987 MEMORANDUM FOR: Hugh L. Thompson, Director Office of Nuclear Material Safety and Safeguards FROM: William G. Mcdonald, Director Office of Administration and Resources Management
SUBJECT:
MANUFACTURER'S REGISTRATION OF RADIATION SAFETY INFORMATION FOR CERTAIN DEVICES AND SEALED SOURCES The Office of Administration and Resources Management concurs in the final rule that would amend 10 CFR Parts 30 and 32 to endorse formally the current practice under which manufacturers of certain devices and sealed sources file radiation safety information about their products with the NRC. We are enclosing marked-up copies of those pages on which we have additional editorial comments..
If you have any questions, please have a member of your staff contact Michael T.
Lesar, Rules and Procedures Branch, Division of Rules and Records on extension 27758.
1111am G. Mcdonald, Director Office of Administration and Resources Management -
Enclosures:
As stated l
y /O Yg g4g NOTE: The editorial changes offered by ARM have been made.
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- JUL1 IS87 1 MEMORANDUM FOR: Hugh L. Thompson, Jr., Director Office of Material Safety & Safeguards FROM: Eric S. Beckjord, Director Office of Nuclear Regulatory Research
SUBJECT:
OFFICE CONCURRENCE REQUEST: AMENDMENT OF 10 CFR PARTS 30 AND 32 -
We have reviewed the subject final rule and concur in its publication.
L We view the rufemaking as codification of existing licensing practice which has been demonstrated to be administrative 1y cost effective.
Please note that several editorial suggestions are provided in the enclosed marked-up copy of the rule.
t
. MM ricS.Beckford,Dihctor i
l Office of Nuclear Re9J1 story Resa&rch
Enclosure:
Marked-up copy of rule .
NOTE: RES suggested 3 editorial
' changes in the Preamble of the FRN. As discussed in the attached Note to File, 1 of the suggested changes has been mad gl..p % >tt?"~
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~$teven Baggett, NMSS
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