ML20248F634
| ML20248F634 | |
| Person / Time | |
|---|---|
| Issue date: | 02/27/1989 |
| From: | Rothschild M NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20248F519 | List: |
| References | |
| FOIA-98-86, RULE-PRM-35-7 NUDOCS 9806040364 | |
| Download: ML20248F634 (3) | |
Text
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,'t UNITED STATES [ 7-j
- j NUCLEAR REGULATORY COMMISSION WA$HING TON, D. C. 20555 L )
"'....],g February 27, 1989 f,
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l NEMORANDUM FOR: Anthony Tse, Nuclear Engineer Regulation Development Branch Division of Regulator) Applications Office of Nuclear Regulatory Research FROM:
Mar.forie U. Rothschild, Attorney Divisicn of Rulemaking and Fuel Cycle Of fice of the General Counsel i
SUBJECT:
PRnPOSED AMEllDMENT OF 10 CFR 635.a00: ADDING FAI.l.AD!llM-103 FOR INTERSTITIAL TREATMENT OF l CAltCER(PRM-35-7)
I have reviewed the et,0ve draf t metrorandum and its enclosures, inclucing the j
draf t Federal Register notice of proposed rulemaking to amend 10 CFR 635.400
("Use of bracytherary sources") to add palledium-103 to the list of l
hracytherapy snurces in $35.400. The proposed rulemaking responds to a petitior, for rulemaking submitted by Theragenics Corp. This pack. age was transmitted for office concurrence.
I We have discussed a n. ark-up of these documents containing my preliniinary concents and suggested revisions. I t, ave now completed my review, including j discussion of the proposed amendc.ent with cognizant IWSS staff (Steven l Beggett and Dr. Donnc-Beth Howe). Attached is the final mark-up of the packagc ccr.taining suegested r(visions and comments. I wcu!d slso like te r.ote the following':
- 1. Pages 2-3. Enclosure A (Notice cf Proposed Rulemaking), the last sentence on page 2 (which centinues en page 3) should be revised to include the appropriate references to "The Federal Food, Drug, i and Cosmetic Act, as amended". Also, inasinuch as the referenced
! letter from the Food and Drug Administration (FDA) appears to be several years old, Dr. Howe is checking to see if the palladium-l 103 seeds have in fact now been classified (as either a Class I, II, or III device) under Section 513 of the Federal Food, Drug and Cosmetic Act, as amended.
- 2. Page 3. Enclosure A, the first sentence of the first full paragraph should he modifico to state why Theragenics submitted infonnation on
..w palladium-lC3 seeds to the State of Georgia. I suggest the followir.g revision of this sentence:
"In March 1986, Theragenics, en " Agreement State" liccesee of /N the State of Georgia, subr.iitted thfonnation on the radiation /I safety properties of palladiurr-103 to Georgit in order to f!
Information in this record was deleted in accordanta with the freedom of Information r
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Act, exemptions 5 t 7y. qt-gt.
' * * : s., ' W . < / Off '
t W I IEl d) l. n h& r/1 t s 6 980528 - -.
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5 obtain a ' Certificate of Registration,' which is necessary for Theragenics to manufacture and distribute palladium-103 seeds to specific licensees."
- 3. Page 3, Enclosure A, last full paragraph, first sentence, this sentence should be modified to indicate that this is an flRC registry.
- 4. Pages 3-4 Enclosure A, the second sentence of the " Conclusion" section of the nutice should be modified to include the basis for the conclusion that the addition of palladium-103 as a sealed source to the list of secled sources specified in 10 CFR 635.400 would not cause additional risk to hospital personnel or the public. Based on my discussion with Dr. Howe, I propose revising this sentence to read as follows:
"The NRC has determined that the additiua of palladium-103 as a sealed source in seeds to the list of sealed sources specified in 10 CFR 935.400 would not cause additional risk to hospital personnel or the public because the radiatice safety and hardling instructions for palladium-103 are similar to the instructions for the brachytherapy sources currently listed'in 635.400."
- 5. Pages 3-4 Enclosure A, the fcurth sentence of the " Conclusion" section should be modified tc read as follows:
"Most users would nct have to follow the present requirement of submitting individual license amendment applications in order to be able to use pa11adium-103 as a sealed source in seeds f or the interstitial treatment of cancer..."
Also, the last sentence of this section should be modified to read as follows:
"A reduction in the number of license amendment applications would reduce the expenditure of NRC staff resources in reviewing and granting or denying the requested license amendments."
- 6. Page 4. Enclosure A. " Environmental Impact: Cate
'first sentence, the citation of 10 CFR 651.22(c)gorical is incorrectExclusion",
E9 inasmuch as there is not any 151.22(c)(2)(1). It appears that thi! pr oposed amendn4pt is the type of action described in
!51.J ic)(2). Therefore, this sentence should be revised to cite 10CFR651.22(c)(2).
- 7. Page 5, Enclosure A. " Regulatory Flexibility Certification", the third sentence of this paragraph should be revised to indicate how the proposed amendment would reduce the regulatory burden on i.
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' medical use licensees. I propose revising this sentence to read as follows:
"This action would reduce the regulatory burden on medical use licensees planning to use the sealed source because most users would not have to follow the present requirement of submitting a license amendment application in order to use palladium-103 as a sealed source in seeds for the interstitial treatment of cancer (if the license permits the use of any I bracythercpy sources specified in 10 CFR 535.d100)."
- 8. Enclosure C (Letter to Congress), first paragraph, last sentence, the last two lines of this sentence should be modified to read as tolicws:
"... add palladium-103 as a sealed source in seeds to the list of brachytherapy sources permitted for use in the interstitial treatment of cancer."
- 9. Enclosure C (Letter to Congress), as presently worded, this letter does not indicate why the flRC is proposing to amend 635.400, other than that the proposed rule would reduce the regulatory burden on 1 medical licensees. Therefore, I would propose adding e new upening sentence to the second paragraph of the letter stating as follows:
l "The proposed amendment would not cause additional risk to hospital personnel or the public because the radiation safety and handling instructions for palladium-103 are similar to the instructions for the brachytherapy sources currently listed in %35.400."
In addition to the above coments and suggested revisions, you will note that there are other suggested revisions made on the attached mark-up, most l l of which are of an editorial nature (or corrections of citations). It is '
my assumption that this package, when revised to reflect my comments and suggested revisions, will be transmitted to us again for final office i
l review and concurrence.
/S/
Marjorie U. Rothschild, Attorney Divisicn of Rulemaking and Fuel Cycle Office of the General Counsel
Attachment:
As stated cc w/ attachment:
S. Treby, 0GC 0.-B. Howe, filiSS S. Chidakel, OGC S. Baggett, NMSS 1
l Pall.A0 DISTRIBUTION
.?/23/89 Central Files OGC r/t OGC s/f MRothschild Sireby Regs
/ ~ ~
OFC RAFC/0GC :0A/R)F0/0GC : : - -
NAME :ttRothschild:jec: Sir'eby : : : :
DATE :2/ 11/89 :?/. /89 . : -