ML20248F619
| ML20248F619 | |
| Person / Time | |
|---|---|
| Issue date: | 10/19/1989 |
| From: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Breaux J, Sharp P, Udall M HOUSE OF REP., ENVIRONMENT & PUBLIC WORKS, HOUSE OF REP., INTERIOR & INSULAR AFFAIRS, SENATE |
| Shared Package | |
| ML20248F519 | List: |
| References | |
| FOIA-98-86 NUDOCS 9806040357 | |
| Download: ML20248F619 (21) | |
Text
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IDDTTICAL IEITERS 30:
Chairman John B. Breaux, Senate Si_th ittee on Nuclear Regulation oc: Alan K. Silipson Chairman 141111o R. Sharp, House Sn h ittee on Energy and Power oc: Carlos J. Moorhead The Honorable Morris K. Udall, Chairman Snbr=nittee on Energy and the Envimme.:nt Cutuittee on Interior and Insular Affairs 1 United States Ibuse of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the enhrmnittee is a copy of a notice of rulemakirry to be published in the Federal Reaister. In response to a petition for rulemaking, the Nuclear Regulatory hianion is ameixiing its regulations to add palladium-103 to the list of bradWapy sources specified in 5 35.400 as a sealed source in seeds for . interstitial treatment of cancer.
The amendment will not increase the risk to the public health and safety but will rduce the regulatory burden to the wimi use licensees who plan to use palladium-103 sealed sources.
Si h y, l
OZIGU;E GIGIiC 3Y I Eric S. Beckjord, Director Office of Nuclear Regulatory Researdi
Enclosure:
Distrib'.Iticri:
Amentnent to subj-circ-diron 10 CFR Part 35 EBeckjord, TSpeis, Toss, IHorris, ZRosztoczy, SBahadur oc: Representative James V. Hamen JTelford, ATse RDB remling files
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MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for Operations -
FROM: Eric S. Beckjord, Director s Office of Nuclear Regulatory Research
SUBJECT:
PROPOSED AMENDMENT TO'10'CFR 35.400: ADDING PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF F CANCER (PRM-35-7) ,
Enclosed for your signature is a' proposed rule (Enclosure A), to be published in the Federal Register, that would amend 10 CFR l Part 35, " Medical Use of Byproduct Material." This amendment would add palladium-103 as a sealed source in seeds to the list I of sealed. sources that may be used in brachytherapy as specified in 10 CFR 5.400, i
! ' BACKGROUND:
L l
A petition for rulemaking was submitted by Theragenics Corporation (PRM-35-7, docketed December 9, 1988) requesting that l
palladium-103 be added to 10 CFR 35.400, "Use of Sources for
! Brachytherapy." 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 in the manner suggested would eliminate this cumbersome process.
Staff review of the petition showed that the addition of palladium-103 to 10 CFR 35.400 would reduce the regulatory burden i on medical licensees who plan to use the sealed source. Thus, as I compared to the current practice,-the proposed change would reduce the burden for both medical licensees and the NRC staff.
!. % wuA War.11; p-^Edregthe same level of protection of the public health and safety because the radiation safety and handling instructions for palladium-103 are similar to the instructions for the brachytherapy sources currently listed in Section 35.400. The proposed rule would grant the petitioner's request by adding s palladium-103 as a sealed source in seeds to the list of approved
% sources in 10 CFR 35.400.
a BACKFIT ANALYSIS:
The staff has determined that a backfit analysis is not required for this proposed rule because the amendment does not constitute '
I a backfit as defined in SeeMem 50.109(a)(1) .
la C P T2 -
, Information in this record was deleted
! in accordar.ce nith the freedom ci in!ctmation 1 Act, exemplicts 5 s
- I-F01A M -
a tu & L4MdQtg ' bJ
i Dr. Anthony N. Tse, Office of FOR FURTHER INFORMATION CONTACT:
Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, j
) Washington, DC 20555, telephone: (301)492-3797.
SUPPLEMENTARY INFORMATION:
' Petition for Rulemaking On November 30, 1988, Theragenics Corporation submitted a (
f petition for rulemaking, PRM-35-7, which was docketed on December 9, 1988. The petitioner requests that the NRC amend its regulations to add palladium-103 ant a sealed source in seeds for ;
the interstitial treatment of cancer to the list of sealed sources currently permitted in 30 CFR 35.400 for use in brachytherapy. A copy of the petition may be obtained from the Regulatory Publications Branch, Division of Freedom of Information and Publications Services, U.S. Nuclear Regulatory l
Commission, Washington, DC 20555.
The petitioner enclosed a document from the Food and Drug of the Department of Health and Human
/ Services Administration that allowsopa, (FDA)L.a,n hng oflladium-103 as a sealed source in seeds.te
/be::rheted. The petitioner stated that, under current NRC I regulations, licensees who are users of palladium-103 must go through the cumbersome process of having their licenses amended before using the product and chat amending 10 CFR 35.400 in the manner suggested would eliminate this cumbersome process.
In supporting the petition, the petitioner submitted several documents, including a letter from the FDA, a safety evaluation 3
report from the State of Georgia, the package insert, and product literature.
The letter from the FDA stated that, under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, as amended, marketing l 2
1 Conclusion 1
The NRC has evaluated the petition and supporting information and proposes to grant the petition. The NRC has determined that the addition of palladium-103 as a sealed source in seeds to the list of sealed sources specified in 10 CFR 35.400 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 Section 35.400. This action would reduce the regulatory burden to the users of palladium-103 seeds (about 700 potential users) as well as to the NRC staff. Most users would not have to follow the present requirement of submitting individcal license amendment applications in order to be able to use palladium-103 as a sealed source in seet.s for the interstitial treatement of cancer (if their license permits the use of any brachytherapy sources specified in 10 CFR 35.400).
/ user / g uld still be required to submit license amendment applications.fi-f?Nirlicenseonlypermitstheuseofspecifg (brachytherapy source [ 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.
Environmental Impact: Categorical Exclusion The NRC has determined that this proposed regulation is the Therefore, typa of action described in 10 CFR 51.22(c)(2).
neither an environmental impact statement nor an environmental
$w assessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork 4
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X. REGULATORY ANALYSIS
$> 10 CFR PART 35 '
, PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER e.
~,
p 1. STATEMENT OF PROBLEM 10 CFR 35.400, "Use of Sources for Brachytherapy," 14e dpreguleti:r.listsspecificradioactivesealedsourcesthat j
may be used for treatment of cancer in brachytherapy. In i
December 1988, the NRC received a petition for rulemaking filed by Theragenics Corporation ~ dated Novembe'r 30, 1988 (docketed PRM-35-7) 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 h
interstitial treatment of cancer to the list of cources specified in 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 procean. p_g
- 2. OBJECTIVES NRC's objectives are to protect the health and safe of ,
porkers and the public in the licensing of byprodue
/ materials for medical uses. The State of Georgia,, performed safety evaluations of the use of palladium-103 and issued a Certificate of Registration. Subsequently, the NRC reviewed A -C 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 presarketing approval of the source and would permit the use of the source provided that the user's license was amended to include the source.
- 3. ALTERNATIVES There are only two alternatives:
(1) Maintainhtatusquo, i.e., M fd: ;; W__ palladium-103 b l e a - +^"" ----
must first apply for and obtain a u p $sj wx license amendment permitting the use; and (2) Amend 10 CFR 35.400 to include palladium-103 as a sealed source in seeds for interstitial treatment of cancer.
Enclosure B
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7-f 4 UNITED STATES y Y p, NUCLEAR REGULATORY COMMISSION ~ J
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MEMORANDUM FOR:
~
Victor Stello,~Jr. .'
Executive Director for Operations FROM: Eric S. Beckjord, Director Office of Nuclear Regulatory Research
SUBJECT:
PROPOSED AMENDMENT TO 10 CFR 35.400: ADDING PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF ^
l CANCER (PRM-35-7) '
d 4ttached for your signature is a proposed rule (Enclosure A), to I Ae published in the Federal Register, that amend ( 10 CFR Part 35,
" Medical Use of Byproduct Material." This amendment would add i
palladium-103 as a sealed source in seeds to the list of sealed sources that may be used in brachytherapy as specified in 10 CFR 35.400. - -
_ _ ~
BACKGROUND:
A petition for rulemaking was submitted by Theragenics Corporation (PRM-35-7, docketed December 9, 1988) requesting that palladium-103 be added to 10 CFR 35.400, "Use of Sources for Brachytherapy)." 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 i product and that amending 10 CFR 35.400 would eliminate this cumbersome process.
! Staff review of the petition showed that the addition of.
palladium-103 to 10 CFR 35.400 would reduce the regulatory burden on medical licensees who plan to use the sealed source. Thus, as jb/ compared to the current practice, the proposed change would reduce the burden for both medical licensees and the NRC staff C21while oviding the same level of protection of the public health safety. The proposed rule would grant the petitioner's
/ request by adding palladium-103 as a sealed source in seeds to the list of approved sources in 10 CFR 35.400.
l Ed f l BACKFIT ANALYSIS:
The staff has determined that a b'ackfit analysis is not required 3 for this proposed rule because the amendment does not constitute a backfit as defined in Section 50.109(a)(1). .
i_
NOTICES:
l A draft regulatory analysis was prepared (Enclosure B).
The appropriate Congressional Committees will be notified
' m 2 _
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6taff review of the petition showed that the addition of palladium-103 to 10 CFR 35.400 would reduce the regulatory burden on medical licensees who plan to use the sealed source. Thus, as compared to the current practice, the -
j proposed change would reduce the burden for both medical licensees and the NRC staff while providing the same level of-protection of the public health and safety.
- Comments were requested previously on the draft Federal Register OGC, notice from the cognizant individuals in NHSS, GPA, and ADM. Appropriate comments were incorporated.
~
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$-}A Eric S. Beckjord, Director
Enclosures:
Office of Nuclear Regulatory Research Memo to Ste.'lo Encia. to the Memo A. FR Notice . -
B. Regulatory Analysis --
C. Draft Congressional letter D. Draft Daily Staff Notes Item cc (w/encle.):
Cognizant individuals 4
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Approved for Publication ' ~' [# O t)\
The Commission" delegated to the EDO (10 CFR 1,2n(n) A[A (di)/the authority to develop and promulgate rules as defined in the APA (5 U.S.C. 551 (4)) subject to the limitations in the NRC Manual Chapter 0103, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213, 038, 039, and 0310.
The enclosed proposed rule, entitled " Palladium-103 for Interstitial Treatment of Cancer," would amend Part 35 to add palladium-103 as a sealed source in seeds to the list of sources specified in 10 CFR 35.400 for brachytherapy. This change would reduce the regulatory burden on medical use licencees who plan to use the sealed source. ,
The propose 1 rule does not constitu'.e a significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7, 8, or 9 Subpart C concerning matters of policy. I, therefore, find that this rule is within the scope of my rulemaking __ _
authority and am proceeding to issue it.
Date Victor Stello, Jr.
Executive Director for Operations N?
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_ d HUCLEAR REGULATORY COMMISSION' 10 CFR Part 35 ,
Palladium-103 for Interstitial Treatment of Cyncer
' AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to l amend its regulations governing the medical uses of byproduct
! material. The proposed regulation would add palladium-103 as a sealed source in seeds to the list cf brachytherapy sources permitted for use in treatment of cancer. Under current NRC q i
regulations, usere must have their licenses' amended before they l
may use palladium-103. The proposed rule, developed in response
! to a petition for rulemaking (PRM-35-7), would reduce the l regulatory burden on medical use licensees who plan to use the sealed source. An evaluation of the potential radiation hazards to hospital personnel and the public showed that there would be minimal risk if the sealed source,is used in accordance with the manufacturer's radiation safety and handling instructions.
DATE: Comment period expires ~(30 days from the date of .
publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except to comments received on or before this date.
iM ADDRESSES: Mail written commente to: Secretary, U.S. Nuclear Regulatory Commission, Washington., DC 20555, Attention:
Docketing and Service Branch. Deliver comments to One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, -
between 7:30 a.m. and 4:15 p.m. weekdays.
Enclosure A
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2 FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of- -
Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: (301)492-3797. ~
SUPPLEMENTARY INFORMATION: -
Petition for Rulemaking L
On November 30, 1988, Theragenics Corporation submitted a petition for rulemaking, PRM-35-7, which was docketed on Deoember 9, 1988. The petitioner requests that the NRC amend its regulations to add palladium-103 as a sealed source in seeds for the interstitial treatment of cancer to the list of sources
/ permitted in 10 CFR 35.400 for use '.n brachytherapy. A copy of the petition may be obtained from the Regulatory Publications Branch, Division of Freedom of Information and Publications Services, U.S. Nuclear Regulatory Commission, Washington, DC
( 20555.
The petitioner enclosed a document from tne Food and Drug Administration (FDA) of the Department of Health and Human i Services that allows palladium-103 as a sealed source in seeds to be marketed titioner stated that, under current NRC (4egulations,puhNiNIium-103 must go through the ,
cumbersome process of naving their licenses amended betore using the product and that amending 10 CFR 35.400 would eliminate this cumbersome process.
In supporting the petition, the petitioner submitted several y documents, including a letter from the FDA, a safety evaluation i
report from the State of Geor cha e insert, a et literature.
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jTheletterfromtheFDAstatedthat , under Section 510 (k) marketing the device (palladium-103 as a sealed source in seeds)
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would be permitted subject to the general controls provisions.of f the Federal Food, Drug, and osmetic Act until such time as'the s / device has been asifie etion 513
% In March 1986 ed informa on on e M t adiation safety properties of palladium-103 to the State of r '
eorg The information on these safety properties included the.
design and construction, prototype testing, conditions of normal use,' labelling, external radiation levels, solubility in body Bpropertiesofthesource, fluids, and quality control and assurance. After reviewing the information and determining the adequacy of the radiation safety the State of Geo.rgia issued a f 4ertificate of Registratiem to Tleragenics on September 22, 1986.
This. certificate summarized the submitted radiation safety information and specified additional' limitations and conditions _
g on the use of the source. This certificate was amended in its ntirety on June 6, 1988 to include a minor design improvement made by Theragenica.
bN owing its determination that the radiation safety
, properties of the source are adequate, the State of eorgia sent MRCacopyofthecertificatetoincludeinthehe stry of Source and Device Designs. The NRC reviewed the certificate for consistency with other certificates in the Registry and added Qy palladium-103 to the Registry on October 29, 1986, and again in h-4, June 1988 to cover the design improvement. This action, in effect, granted a(frenarketina =ppmval of the sealed source)and wowM permitNhe use of palladium-103 provided that the user's S license was amended to include sealed source. .
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Conclusion g$p
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(/ The NRC has us...J. the petitio an suppor ornation and proposes to grant the petition. The addition of palladium-103 as a sealed source in seeds to the list of sealed
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CFRJ35.400 woul not,cause a tiona f iak to hospital personnel o r the public.\ This' acl- uld. -
g /feduce the regulatory burden to the uscre a out ce -
L4 well as to the NRC staff. LHost users would notl ate _t individual license amendment'3tu rnes are !
of any brachytherapy source specified in 10 CFR 35.400). -
However,someuserswould[tillberequiredtosubmitlicen amendments (if their lice.se only permits the use of specif;e !
brachytherapy sources). 7 6 NRC .i, II'o offcrt; d reviewi d
[h[ '
the license amendments,;ould $1.0 L icduced-
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Q Environmental Impact: Categorical E lu EK5 AL i
RC has determined that this proposed eg n ;
p ype of action described in 10 CFR 51.26)(2)@ Therefore, l neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statement '
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This proposed rule does not contain a new or amended i formation collection requ rement subject to the Paperwork eduction Act of 1980 ( .S.C. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget, approval number 3150-0010.
Regulatory Analysis The NRC has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the NRC. The draft regulatory analysis is available for inspection in the NRC Public Document Room, 2120 L Street, Lower Level, NW, Washington, DC.
Single copies of the draft regulatory analysis may be obtained from Dr. Anthony H. Tse (See FOR FURTHER INFORMATION CONTACT heading).
5 [7509-01]
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'The NRC requests public comments on the draft regulatory analysis. Comments may be submitted to the NRC'(See ADDRESSES' ,
heading).
Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule, if adopted, will not have a significant, economic impact on a substantial number of small entities. The proposed rule would y - add the use of palladium-103 as a sealed source in seeds in 10 l CFR 35.400. Thisactio(wouldreducetheregulatoryburdenon medical use 1 es d.c, N a to use the sealed source.
' The NRO has adopted size standards that classify a hospital as a small entity if its annual gross receipts do not exceed $3.5 million, and a private practice physician as a small entity if the physician's annual gross receipts are $1.0 million or less.
Although'some NRC medical use licensees could be considered N "small entities," the number that would fall into this category
.( }doesnotconstituteasubstantialnumberforpurposesofthe ;
4 Regulatory Flexibility Act. However, the proposed rule would -
L have a positive economic impact on about 700 licensees.
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l' Backfit Analysis i The NRC has determined that a backfit analysis is not required or this proposed regulation becau e the amendment does not o
/ constitute a backfit as defined g i"n b0.109(a)(1).
List of Subjects in 10 CFR Part 35 Byproduct material, Drugs, Health facilities, Health Professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
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E l For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C 553, the NRC is proposing to adopt the following amendment to 10 CFR Part 35.
> 1
- 1. The authority citation for Part 35 continues to read as follows:
AUTHORITY: Sees. 81, 161, 182,"183, 68 Stat. 935, 948,<953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 86 Stat. 1242, as amended (42 U.S.C. 5841).
For the purposes of sec. 223, G8 Stat. 958, as amended (42 U.S.C. 2273); 55 35.11, 35.13, 35.20(a) and,(b), 35.21(a) and (b), 35.22, 35.23, 35.25, 35.27(a), (c) and (d), 35.31(a), 35.49, ___
35.50(a)-(d), 35.51(a)-(c), 35.53(a) and (b), 35.59(a)-(c),
(e)(1), (g) and (h), 35.60, 35.61, 35.70(a)-(f), 35.75, 35.80(a)-(e), 35.90, 35.92(a), 35.120, 35.200(b), 35.204(a) and 3 (b), 35.205, 35.220, 35.310(a), 35.315, 35.320, 35.400, '
35.404(a), 35.406(a) and (c), 35.410(a), 35.415, 35.420, 35.500, 35.520, 35.605, 35.606, 35.610(a) and (b), 35.615, 35.620, 35.630(a) and (b), 35.632(a)-(f), 35.633(a)-(i), 35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b), 35.645(a) and (b),
35.900, 35.910, 35.920, 35.'930, 35.932, 35.934, 35.940, 35.941, 35.950, 35.960, 35.961, 35.970, and 35.971 are issued under sec.
161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and 33 35.14, 35.21(b), 35.22(b), 35.23(b), 35.27(a) and (c),
35.29(b), 35.33(a)-(d), 35.36(b), 35.50(e), 35.51(d), 35.53(c),
" 35.59(d) and (e)(2), 35.59(g) and (i), 35.70(g), 35.80(f),
35.92(b), 35.204(c), 35.310(b), 35.315(b), 35.404(b), 35.406(b) and (d), 35.410(b), 35.415(b), 35.610(c), 35.615(d)(4),
35.630(c), 35.632(g), 35.634(j), 35.636(c), 35.641(c), 35.643(c),
35.645, and 35.647(c) are issued under sec. 161o, 68 Stat. 950 as amended (42 U.S.C. 2201(o)).
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! 2. In s35.400, paragraph (g) is added tg read as follows:
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s 35.400 Use of sources for brachytherapy.
(g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer. -
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Dated at Rockville, Maryland, this day of
, 1989. . -
l For the Nuclear Regulatory Commission. I i
Victor Stello, Jr.
Executive Director for Operations i
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REGULATORY ANALYSIS 10 CFR PART 35 -
PALLADIUM-103 FOR INTERSTITIAL TREATHENT OF CANCER l 1. STATEMENT OF PROBLEM In-10 CFR 35.400, "Use of Sources for Brachytherapy," the regulation lists specific radioactive sealed sources that may be used for treatment of cancer in brachytherapy. In
. December 1988, the NRC received a petition for rulemaking filed by Theragenics Corporation-dated November 30, 1988 (docketed PRM-35-7) to amend 10 CFR 35.400.
l The petitioner requested that the NRC amend its regulations to add palladium-103 as a sealed source in seeds for j l interstitial treatment of cancer to the list of sources !
specified in 10 CFR 35.400. T'.e 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 _ _ . , 1 35.400 would eliminate this cumbersome process. !
(
- 2. OBJECTIVES l
NRC's objectives are to protect the health and safety of i workers and the public in the licensing of byproduct materials for medical uses. The State of Georgia performed l 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 i the Registry of Source and Device Designs and added palJadium-103 to the Registry. This action, in effect, granted a presarketing approval of the source and would permit the use of the source provided that the user's license was amended to include the source.
- 3. ALTERNATIVES
,;q- There are only two alternatives:
(1) Maintain status quo, i.e., before using palladium-103, a potential user must first apply for and obtain a license amendment permitting the use; and l (2) Amend 10 CFR 35.400 to include palladium-103 as a sealed source in seeds for interstitial treatment of cancer.
Enclosune B
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- 4. CONSEQUENCES ,
l I In terms of the public. health and safety, both alternatives l would permit the use of palladium-103 as r, sealed source in seeds for brachytherapy, thus, there would be essentially no difference between the two alternatives.
In terms of cost, alternative 2 would be less burdensome for both the medical use licensees and the NRC. Alternative 2, if adopted, would eliminate the amendment application process for most licensees who plan to use the sealed source and the review and approval process for the NRC.
i
- 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 Nhc proposes to adopt this alternative.
- 6. IMPLEMENTATION Implementation involves adding palladium-103 as a sealed source in seeds for interstitial treatment of cancer in 10 CFR 35.400.
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l (Identical letters to be sent j to other Subcommittees) l ,_
The Honorable John B. Breaux, Chairman 1 l Subcommittee on Nuclear Regulation -
! Committee on Environment and Public Works M'
United States Senate -
l Washington, DC. 205{d i
[
Dear Mr. Chairman:
Enclosed for the nformation of the subcommittee is a copy of a notice of Proposed Rulemaking to be published in the Federal l i Register. response to a petition for rulemaking, the Nuclearg ,, , ,,
, Reculatory g ommission is proposing ,o amend its regulations eccd Wi Nuee efhe-a--see4=u tr ;t= cat of-canear., -
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hTheproposedrulewouldreducetheregulatoryburdenonmedical i g ee licensees chich pla Q use the sealed sourcey The notice will be mailed to medical use licensees and other .
interested individuals for comment. We expect the medical l community will be very interested in the notice. l Sincerely, l
Eric S. Beckjord, Director Office of Nuclear regulatory Research l
Enclosure:
Federal Register notice cc: Senator Alan K. Simpson Enclosure C
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t WEEKLY REPORT TO THE COMMISSIOh 0FFICE OF NUCLEAR REGULATORY RESEARCH I
Proposed Rule to be signed by EDO On , the Executive Director for Operations 1 approved a proposed rule that would amend 10 CFR 35.100, "Use of l
Sources for Brachytherapy." This amendment, developed in response to a petition for rulemaking (PRM-35-7, Theragenics l Corporation, docketed December 9, 1988), would add palladium-103 '
as a sealed source in seeds to the list of sources specified in 10 CFR 35.400. The change would reduce the regulatory burden on medical use licensees who plan to use the sealed source.
l This constitutes notice to the Commission that, in accordance with the rulemaking authority delegated to_the EDO, the EDO has signed this proposed rule and proposes to forward it to the ,
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Office of the Federal Register for publication. !
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Enclosure D
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NOTICES: ,
A draft regulatory analysis was prepared (Enclosure B).
The appropriate Congressional Committees will be notified (Enclosure C). A A weekly report to the Commission was prepared letter will be sent to notify the petitior.er of (Enclosure D).
l the proposed rule. Public Affairs /GPA has indicated that a public announcement is not needed.
COORDINATION:
se Offices of Nuclear Material Safety and Safeguards, Administration, and Governmental and Public Affairs concur in this amendment. The Office of General Counsel has no legal objection.
Eric S. Beckjord, Director Office of Nuclear Regulatory Research
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Enclosures:
A. FRN - proposed rulemaking _ _ _ .
B. Draft regulatory analysis, C. Draft congressional letter D. Draft weekly report to Commission DISTRIBUTION (w/o encle.):
Subj-chronecire, RDB reading file RES: EBeckjord, TSpeis, BMorris, ZRosatoczy, WLahc, JTelford, ATse(w/encls.)
NMSS; RBernero, NMcElroy GPA: HDenton, LBolling OGC: WParler, MRothschild ADM: PNorry, MLesar RES
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^ EBeckjord 2/ /89 DRA/RES DRA/RES RES OFF: RDB/DRA RDB/DRA NAME: Tse/Telford WLahs ZRosztoczy BMorris TSpeis DATE: 1/26/89 2/ /89 2/ /89 2/ /89 2/ /89
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