ML20244D875
| ML20244D875 | |
| Person / Time | |
|---|---|
| Issue date: | 04/17/1989 |
| From: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | |
| References | |
| FRN-54FR13892, RULE-PR-35 54FR13892, NUDOCS 8904240169 | |
| Download: ML20244D875 (2) | |
Text
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4 DOCKET NUMBER DD PROPOSE RULE ED M
( l'R l389;L REGULATORY ANALYSIS 10 CFR PART 35 e O A PALLADIUM-103 FOR INTERSTITIAL TREATMENT CANCER 3 g
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- 1. STATEMENT OF PROBLEM '
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10 CFR 35.400, "Use of Sources for Brachyt JMP specific radioactive sealed sources that ma u for U treatment of cancer in brachytherapy. In De r 19M e NRC received a petition for rulemaking filed b *T66eald ce Corporation dated November 30, 1988 (docketed PR '~- to amend 10 CFR 35.400.
The petitioner requested that the NRC amend its regulations to add palladium-103 as a sealed source in seeds for interstitial specified in treatment of cancer to the list of sources 10 CFR 35.400. The petitioner stated that, under the present regulation, users of palladium-103 must go through the cumbersome process of amending their licenses before they can use the product and that amending 10 CFR 35.400 would eliminate this cumbersome process.
- 2. OBJECTIVES '
HRC's objectives are to protect the health and safety of workers and the public in the licensing of byproduct materials for medical uses. The State of Georgia, an
" Agreement State" which licenses Theragenics, performed safety evaluations of the use of palladium-103 and issued a Certificate of Registration. Subsequently, the NRC reviewed the certificate for consistency with other certificates in the Registry of Source and Device Designs and added palladium-103 to the Registry. This action, in effect, granted a premarketing approval of the source and would permit the use of the source pr'ovided that the user's license was amended to include the source.
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- 3. ALTERNATIVES There are only two alternatives:
(1) Maintain the status quo, i.e., a licensee seeking to use palladium-103 must first apply for and obtain a license amendment permitting the use; and .
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e (2) Amend 10 CFR 35.400 to include palladium-103 as a sealed source in seeds for interstitial treatment of cancer.
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- 4. CONSEQUENCES In terms of the public health and safety, both alternatives would' permit the use of palladium-103 as a sealed source:in seeds for brachytherapy, thus, there would be essentially no difference between the two alternatives.
In terms of cost, both the medical use licensees and the NRC. alternative if adopted, would eliminate the amendment applicationAlternative 2, process for most licensees who plan to use the sealed source and the review and approval process for the NRC.
- 5. DECISION RATIONALE Since Alternative 2 would result in less burden to the medical use licensees and the NRC staff while providing the same level of protection of the public health and safety, the NRC proposes to adopt this alternative.
- 6. IMPLEMENTATION Implementation involves adding palladium-103 as a sealed source CFR in seeds 35.400. for interstitial treatment of cancer in 10 Mb['5/RM Rc e
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