ML20236R540

Notation Vote Approving W/Comments SECY-98-128, Proposed Rule,Rev of 10CFR35,Medical Use of Byproduct Matl

ML20236R540
Person / Time
Issue date:	07/09/1998
From:	Mcgaffigan E NRC COMMISSION (OCM)
To:	Hoyle J NRC OFFICE OF THE SECRETARY (SECY)
Shared Package
ML20236R530	List: ML20236R528 ML20236R534 ML20236R537 ML20236R540
References
SECY-98-128-C, NUDOCS 9807220105
Download: ML20236R540 (15)

Text

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d e- NOTATION VOTE RESPONSE SHEET.

TO: John C. Hoyle, Secretary

- FROM! COMMISSIONER MCGAFFIGAN

SUBJECT:

SECY-98-128 - PROPOSED RULE: REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL

' Approved ~ X' Disapproved Abstain Not Participating- Request Discussion COMMENTS:

See attached comments, n -

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SIGNATURE /L (i(/

Release Vote / N / $ 9 , l'l N DATE O Withhold Vote / /

Entered on "AS" Yes F No l

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.. CottRESPONDENCE PDR

. 1 Commissioner McGaffican's Comments on SECY 08-128:

I 1 commend the staff for their exhaustive efforts in des eloping a proposed rule through an l enhanced participatory process en such a short deadline, and I approve publication of the J proposed rule for public comment subject to the modifications described below. With regard to the request from the Advisory Committee on the Medical Uses ofIsotopes during the recent public Commission briefing to extend the public comment period from 75 to 120 days. that has I since been seconded by several stakeholder. I believe we need to grant the request, although I recognize that this will reduce the time for the staff to resolve comments before submitting the final rule to the Commission for approval in May 1999. As I stated in my vote on SECY-98-127.

the staff could delay finalization of the Medical Use Policy Statement until after the final rule is promulgated.

Based on a review of the information provided and the recent public briefing. I offer the foNwing comments on various cross-cutting and technical issues for the staff's consideration in further development of the proposed rule package.

1. Training and Experience Criteria - Regarding the therapeutic use ofiodine-131. I recognize that the treatment of thyroid cancer is more significant from a patient risk perspective than il ratment of hyperthyroidism because of the quantities typically administered to '." vies.t. As such,I support the increased training and experience requirements fo: i reatment of thyroid cancer to ensure consistency with the training and experience : .t .rements for the therapeutic use of other radiopharmaceuticals that pose similar risks. However, I continue to be concerned that the proposed increase in training and experience requirements for endocrinologists who administer iodine-131 for hyperthyroidism cannot be justified from a public health and safety perspective.

Therefore,I do not support the proposed increased training and experience requirements for the treatment of hyperthyroidism in the absence of a clear safety basis and instead support retention of the current requirements in 10 CFR 35.932.

I also fully support the proposed increase in training and experience requiren-its for users of Strontium-90 eye applicators based on recent and past history of events involving multiple misadministration with this device.

With regard to the emerging field ofintravascular brachytherapy. the staff should continue to keep abreast of this evolving technology to ensure that our radiation safety requirements, including training and experience for users and the use of the team approach and its composition, appropriately reflect the risks associated with these procedures. While 1 do not recommend changing the composition of the team at this time,it seems appropriate to eliminate the requirement for a radiation oncologist to be present during the procedure once the clinical trials are complete and the medical er mmunity has made final decisions regarding the isotope of choice and the appropriate cuantity.

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2. Radiation Safety Committee - I continue to be concemed that the lack of a dedicated j

committee for the sole purpose of overseeing the radiation protection program will prove i

problematic from a public health and safety perspective. Apparently, this concern has also been expressed in the majority of written comments received thus far and by health physicists, radiation safety officers (RSOs) and others during public meetings. While the draft proposed rule is specific with regard to the role, authority, responsibilities, etc. of the RSO, it is silent on the RSO's relationship to the one or more committees that are 1 designated by the licensee as responsible for oversight of the radiation protection program. Yet, the draft rule requires that the RSO agree,in wTiting, to be responsible for implementation of the program. There is a disconnect between what we expect of the RSO and what mechanisms are in place to empower the RSO. This situation may make it extremely difficult for some RSOs to receive the time and attention from senior licensee man?;ement and necessary resources to ensure public health and safety. Finally. while I do not support the current overly prescriptive r quirernents for a radiation safety committee in 10 CFR 35.22, I do not support the total elimination of a stand-alone RSC at a time when licensees must assume greater responsibility for the licensed program under the more performance-based rule. One step at a time, and in my opinion, this step is unacceptably large. Therefore, I suggest that the proposed rule package solicit comment on whether the rule language should be modified to explicitly require that the RSO be a member of the committee primarily responsible for overseeing the radiation protection program in the event that the proposed requirements are fundamentally retained.

3. Patient Notification - As indicated in my vote on SECY-98-054, I continue to support f the current patient notification and related record keeping requirements with one l

modification to address concems by some members of the medical community that the

! current option of providing the patient with a copy of the report provided to NRC can greatly magnify the significance of an event which could be of minimal safety significance. While I understand that some staff would prefer that the patient be informed of the existence of the NRC report,I do not support including a prowion in the rule to accomplish this since required reports to NRC may be unnecessarily alarming to the ptient because they are very bureaucratic in tone and are not typically written in laymen's terms. As a result,I suggest that the language be modified as follows:

35.3045(e)- If the individual was notified pursuant to paragraph (d) of this section, the licensee shall also furnish, within 15 days after discovery of the l

medical event, a written report to the individual that includes a brief description of the event and the consequences as they may affect the individual.

4. Precursor Events - As indicated in my vote on SECY-98-054,I support specific Part 35  ;

rule language to capture precursor events rather than relying on current reporting requirements in other parts that have proven to be less than effective. Ilowever. I suggest that proposed rule be modified to read,"in the opinion of the licensee" rather than in "the opinion of the radiation safety officer or authorized user" to make it consistent with other

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I reporting requirements (10 CFR 34.30 and 36.83) which make the licensee responsible i for reporting certain events and are silent with regard to who at the licensed facility i makes the determination of deportability. I recognize that there has been some controversy over the intent of and need for such requirements; however, by including

- them in the proposed rule, the staff has the flexibility to modify the final rule to revise or delete the reporting requirements if public comment is not supportive.

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5. Reporting requirements for unintentional exposure of an embryo / fetus or nursing child - I support the proposed reporting requirements but suggest that the proposed rule

. be modified to contain notification requirements similar to the " patient notification" E requirements to include allowing the referring physician discretion in deciding whether to notify the mother of the event.~ lt seems inappropriate to notify the regulator, notice that would be publicly available, and not the mother. The proposed rule package should i specifically solicit public comment on this issue.

6. Record keeping requirements - While i recognize that m:.ny record keeping requirements are being codified for the first time (e.g., those related to remote afterloader brachytherapy), the list may appear overwhelming to some. The staff should continue to review the proposed record keeping requirements to determine if there are any that could be deleted, and if so, specifically solicit comment on those requirements. For example, the requirement in 35.2063 to keep records of unsealed patient dosages of byproduct material does not exempt " low-risk" dosages administered pursuant to 35.100 or 35.200.

This seems internally inconsistent since the proposed rule does not require that unit dosages be assayed, 7, Specific comments on certain proposed requirements -

f 10 CFR 35.12(c)- While the proposed rule language reflects current practice ofissuing licenses for teletherapy and gamma radiosurgery separately from other medical uses. the basis for this approach should be briefly explained in the statement of considerations.

10 CFR 35,13(a)- The staff should consider changing the words," clinical procedure" to

" type of use" or similar verbiage to more accurately reflect that types of use are authorized on the license and not specific clinical procedures.

10 CFR 35.13(e) and (f)- The staff should ensure that the distinction between authorized areas / areas of use (e.g., buildings, rooms) and address / address of use (e.g., mailing address) made in these items is clear.

10 CFR 35.390(b)(1)(ii) - This item should be modified to add th. text from the proposed item 35.390(b)(2) into section 35.390(b)(1)(ii) as item (F) so as to make it clear that the required five case studies can be done concurrent with the required 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of practical training required by 35.390(b)(1)(ii). Conforming changes are necessary to renumber the remaining section items.

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. Suggested editorial changes to the I ederal Register notice, letters to Congress. and press release are indicated on the attached pages.

More minor editorial changes to the l'ederal Ergister notice were provided to the staff informally.- .,

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[7590-01-P]

NUCLEAR REGULATORY COMMISSION 4

10 CFR Parts 20,32 and 35 RIN 3150-AF97 Medical Use of Byproduct Material; Proposed Revision AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule

SUMMARY

The Nuclear Regulatory Commission (NRC)is proposing a revision of its regulations goveming the medical use of byproduct matenal. The proposed rule is one component of the Commission's overall program for revising its regulatory framework for medical use. The overall goals of this program are to focus NRC's regulations on those i

medical procedures that pose the highest nskynd to structure its regulations to be rM L ] V risk-informed and erformance-based, consistent with the NRC's " Strategic Plan for Fiscal Year 1997- Fiscal Year 2002." A separate notice in he Federal Register announced the Commission's proposed revision of its 1979 *M ical Use Policy Statementy b (Ek * "

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i DATES: The comment period expires [ insert date 75 days after publication). Comments l received after this date will be considered if it is practical to do so, but the Commission is only l

able to ensure consideration of comments received on or before this date.

I ADDRESSES: Comments may be sent to: Secretary, U.S. Nuclear Regulatory Commission.

Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff.

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State and Federal Regulations Byproduct material or radiation from byproduct materialis regulated by either State or Federal Laws. The NRC regulates the administration of byproduct matenal or radiation from i

byproduct materic!in 20 States, the District of Columbia, the Commonwealth of Puerto Rico, and various territories of the United States There are approximately 1900 NRC licenses authorizing the medical use of byproduct material under 10 CFR Part 35," Medical Uses of Byproduct Material." Thirty States, known as Agreement States, have entered into an agreement with the NRC to regulate the use of byproduct materio. (as authorized by section 274 of the Atomic Energy Act). These States issue licenses and currently regulate about 5000 institutions, e.g., hospitals, clinics, or physicians in pnvate practice. $< v/odu se [d pNd eid (e pse sert on\ a sw llkrhcAcn ok d <w h d ut L n d n sid G b rokombes st Suw es h ed di c. .,

Revision of NRC's Reaulatory Proaram X-m NRC's medical use program includes use of byproduct material in medical diagnosis, gesuaed .

3r 1 therapy, and research. NRC's requirements for medicallicensees are n 10 CFR Part 35. [w "

g EIleven million patients annually undergo medical procedures involving byproduct materials.

The Commission examined the issues surrounding its medical use program in detail during a 1993 intemal senior management review, a 1996 independent extemal review by the National Academy of Sciences, Institute of Medicine, and the Commission's Strategic

% 44 hvo 1 Assessment and Rebaselining . (SA). In particular, medical oversight was addressed in l

I the SA Direction-Setting issue Paper Number 7 (DSI 7) (released September 16,1996). In September 1997, the Commissioriissued its " Strategic Plan" (NUREG-1614 Vol.1) which 5

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consistent with release of patients in accotdance with @~ 3575, or with the approach to protection of the public in 10 CFR Part 20. For this reason, the NRC decided not to adopt the suggested 50 mSv (5 rem) dose limit.

The NRC reviewed the petitioner's request and comments received on the petition and believes there is merit in granting the petition in part as discussed in detaillater, This proposed rule responds to the petition by amending 10 CFR Part 20 to allow the licensee the discretion to permit visitors to receive up to 5 mSv (0.5 rem) in a year from exposure to hospitahzed radiation patients.

111. Discussion and input to Proposed Rule.

The program for revising Part 35 and the associated guidance documents has provided more opportunity for input from potentially affected parties (the medical community and the public) than is provided by the typical notice and comment rulemaking process. Early pubhc input was solicited through several different mechanisms: requesting public input through Federal Register notices; holding open meetings of the govemment groups developing the revised rule language; meeting with medical professional societies and boards; putting background documents, options for the more significant regulatory issues associated with the rulemaking, and attematives for revising the 1979 Medical Use Policy Statement on the Intemet; and convening public workshops. The input received from the public during the development of the proposed rulemakin is categorized and summanzed below, according to the significant regulatory issues that ere identified very early in the rulemaking process.

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overall benefits to the regulatory framework They believed that the FDA regulatory scheme is comprehensive, requinng documentation of adverse effects relating to the use of all drug products. including radionuclides; regulations under 10 CFR Part 20 are adequate to protect health and safety; high-nsk medical use can be regulated on a case-by-case basis through licensing conditions; and some prescriptive license conditions can be offset by performance-based flexibility, which is preferable to presenptive regulations of medical users.

Finally, some commenters questioned the schedule for completion of the rulemaking.

. They Leiieve that sufficient time mur. be provided to undertake a thorough effort to change the rule and for public comment on draft documents, including regulatory guides. They also believe that reorganization of Part 35 based on "similar subject areas"is appropriate, but the rule .

should include references to requirements in Part 20.

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b, Resolution.

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Mp% o A1.6e Commission considered input from a 1993 intemal senior 3

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• W report; extemal review report by the National Academy of Sciences, institute of Medicine; and i

is M, information presented in the Strategic Assessment Direction-Setting issue Paper Number 7 ac,d i"

(DSI-7) prior to determinirig the role of NRC regulation in the medics; use area. On the basis of Efspt S *d these reviews, the Commission believes that Part 35 should be restructured into a v r c r ~ A%., u .

risk-informed, more performance-based regulation. In developing the regulation, the tdai a1L hti L Comrnission considered information on risk provided by members of the public and professional (q

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societies, professional medical standards of practice, and event databases ma_intained by~NRC. ,

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IV. Discussion of Text of Proposed Rule

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10 CFR PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION Section 20.1301, Dose limits for individual members of the public, would be revised.

The proposed rule responds to the petition from the University of Cincinnati by amending S 20.1301 to allow a licensee the discretion to permit visitors to receive up to 5 mSv ( 0.5 rem) in a year from exposure to individuals who are not releasable pursuant to S 35,75. Currently, visitors are limited to 1 mSv ( 0.1 rem). [ , ,,L 4 it 4/ tt e '*

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- The C'ommission has used 5 mSv (0.5 rem) as a threshold for action in multiple 575 location 9 in Parts 20 and 35. This threshold is used as both a dose limit and a reporting level, i

For example, a 35.75 uses the 5 mSv (0.5 rem) as a dose limith The proposed change to @

20.1301 would also use'5 mSv (0.5 rem) as a dose limitq In contrast, however, the proposed

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changes to S 35.3047, Report of a dose to an embryo /fetds or a nursing child, would establish a

' 5 mSv (0.5 rem) reporting threshold (reference S 36.3047 for a more detailed discussion of the proposed change). g y .m ,1 .e in accordance with S 35.75, patients containing radioactive material can be released from licensee control if the total dose to other individuals from exposure to the released patient L

is not likely to exceed 5 mSv ( 0.5 rem). The Commission recognizes that the provisions of

! ' S 35.75 and the proposed revision to S 20.1301(a) could result in rare instances in which certain i

individuals could receive a 10 mSv (1.0 rem) dose. For example, an individual could receive a 5 mSv (0.5 rem) dose while visiting a patient who can not be released pursuant to S 35.75, and 54 L__._____.______.___________

In order to reduce regulatory burden, paragraph (e) would be revised to delete the l requirement for a licensee to apply for a license amendment if there is a change in the areas

. y 490sh cp ma) where b'yproduct materialis used pursuant to @9@ 35.100 and 35.200. However, thi

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does not apply t storage or waste areas because of the potential for large quantities of materials to accumulate in these areas and the possibility of commingling of radioactive material that is used pursuant to other sections of the rule.

I Section 35.14, Notifications, would be revised. Paragraph (a) would be revised to L include a requirement for the licensee to notify NRC no later than 30 days after the date the j

licensee permits an individual to work as an authorized medical physicist pursuant to l

6 35.13(b). ' Paragraph (b) would be revised to require that the licensee notify NRC when an l

. authorized medical physicist permanently discontinues performance of duties under the license.

l Paragraph (b) would also be revised to require that a licensee notify NRC when the licensee changes its name. This provision applies only if there is no change in ownership, as described in 30.34 of this chapter. Otherwise, the licensee must take appropriate action to have its Iicense amendedfA licensee must also notify NRC of any changes in areas where materials

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l-l are used pursuant $9 35.100 and 35.200. These revisions were warranted because of l

requirements in the oposed 35.13.

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• l Section 35.15, Exemptions regarding Type A specific licenses of broad scope, wou!d be revised to add the term

• authorized medical physicist" to paragraph (d). This revision is needed L

because of the requirements ',n the proposed @ 35.13. Under this proposed section, broad

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i' scope licensees would have authority to appoint authorized users, authonzed nuclear 63

I exceeds the thresholas discussed above. Reporting under @ 35.3047 would not necessanly be subject to enforcement action if the licensee had complied with @ 35.75. Although the regulation requires that the licensee provide information on the cause of the incident and corrective actions to prevent recurrence, NRC acknowledges that in many, and if not all, incidents, the liceissee might not have been able to prevent the incident because the individual

)L hhave opted not to disclose her pregnancy or nursing status. NRC is soliciting specific public comment on the impacts of this reporting requirement on licensee procedures, activities, I

or medical practices.

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%ofhwW m}" f Section 35.3067, Reports of leaking sources, would require the licensee to file a report I

with the appropriate NRC Office listed in @ 30.6 of this chapter, with a copy to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, within 5 days if a leaxage test required by Q 35.67 reveals the presence of 185 Bq (0.005 inicrocurie) or more of removable contamination. This reporting requirement is similar to the current requirements for leaking scurces. The report must contain the model number and serial number if assigned, of the leaking source; Radio nuclide and its estimated activity; the measured activity of each test sample expressed in microcuries; a desenption of the method used to measure each test sample; the date of the test; and the action taken.

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Subpart N. Enforcement, contains statements regarding enforcement. This subpart would replace the statements in the current Subpart K. Enforcement.

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y 1 UNITED STATES

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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205654001 o

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( The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power g 69 T)~ ,[:,. h

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, Committee on Commerce l United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the Subcommittee's information is a copy of a notice of a proposed rulemakin to x be published in the Federal Reaister for a 75-day public comment period (Enclosure 1). A copy x

of the press release for the rulemakingprovided in Enclosure 2.

is The U.S. Nuclear Reguiatory Commission (NRC) is proposing to revise its regulaCons in 10 CFR Part 35, " Medical Uses of Byproduct Material," as part of an overall program to revise the Commission's regulatory framework for medical use. The goal of this proposed rulemaking is to restructurgPart 35 into a risk-informed, more performance-based regulation that focuses x

• e re;"Was on those medical procedures that pose the highest risy frcm a radiation safety aspect, with a dxqddecrease in the oversight of low-risk activities. Another component x of the program, revision of NRC's 1979

• Medical Use Policy Statemeht," is being separately y published and transmitted to the Subcommittee.

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The process used to revise Part 35 has provided more opportunity for input from potentially f affected parties (the medical community and the pubiic) than is provided by the typical notice and comment rulemaking process. Early public input was solicited through several different mechanisms: requesting public input through Enderal Reaister notices; holding open meetings of the govemment groups developing the revised rule languag meeting with medical professional societies and boards; putting background docume s, options for the more significant regulatory issues associated with the rulemaking, an an early "strawman" revision of the draft proposed rule on the Intemet and in NRC's Public D cument Room; and convening b d public workshops. The staff benefitted from these interactions a d received many useful commentsMA have been inwpouAeA. inh N p<orm A < A  % s d he.s (cb, A4, / u b ckib r#a.) c m'4 h so b't (g 4Ag ipe pw h bd3 lq N ide. S ncerely, j '

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Gd e t en Mc As J Vses i d J'iobps _

Dennis K. Rathbun. Director Office of Congressional Affairs i Enclosures '

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1. Federal Reaister Notice

, 2. Press Release i cc: Representative Ralph Hall i

Draft press release - 5/20198,10:35 a.m.

NRC PROPOSES EXTENSIVE REVISIONS TO REGULATIONS ON MEDICAL USES OF RADIOACTIVE MATERIAL The Nuclear Regulatory Commission is proposing extensive revisions to its regulations on medical uses of radioactive material. The revisions, designed to be risk-re e4 6 -

informed and performance-based, focus regulation on the medical procedures that pose X A

the highest risk,from a radiation safety aspect.

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The NRC regulates the use of.r.adioastw# material in medical diagnosis and '

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'h redc< M treatment, as well as research.he<e i mne.- e; ;e ed...:.7 :': ;d dbout eleven million l patients a year. g j ,hal r.

In developing the proposed changes to the regulations, the NRC provided extensive opportunities for public inpu Publicly announced meetings and workshops Y were held last year and this year where rulemakirg alternatives for significant " cross-cutting issues" were discussed. The alternatives for the cross-cutting issues were discussed with the NRC's Advisory Committee on the Medical Uses of isotopes, as well as with state regulators, medical professional societies, and the public at meetings in l Philadelphia and Chicago. In addition, the ru;emaking alternatives and an early

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"strawman" version of the NRC staff's proposed revisions to the regulations were made available for comment on the Internet and in the NRC's Public Document Room in Washington, DC. M e erl as 1 ok @s ga. 2 in general, the proposed changes to the regulations reflect an overal: change in p e--

x regulatory philosophy to make the regulation performance based and to delete some of

- the more detailed requirements. An applicant for an NRC medical-use license would have to develop and implement procedures, but would no longer be required to submit 1

4 associated with these procedures. Training and experience were the primary concerns expressed by the public comments during development of the proposed changes to the regulations. Most of the commenters thought the current requirements should be retained. Under the proposed revisions, the current training requirements would stay in effect for two years to allow licensees time to implement the new requirements. During {

the intervening period, licensees would have the option of meeting either the current or the revised requirements.

(5) Precursor events - The proposed revisions to thu regulations require licensees to notify the NRC after identifying any defects, exclusive of ordinary equipment failures, in equipment (hardware and/or software), radioactive material, or

% uJ procedures supplied by a manufacturer or vendor that, in the opinion of the_sadiatio9 y

. safety efficer-or, unauthorized-user,' could lead to a medical event. j l

The proposed changes to the regulations also address a petition for rulemaking {

I filed by the University of Cincinnati. The petition requests a 500-millirem radiation dose limit for certain individuals visiting patients who are required to be confined to the I hospital while receiving radiation treatment, where the visitors are determined by the physician to be necessary for tha patient's emotional or physical support. The current limit of 100 millirem for visitors is the same as for members of the public under other '/

circumstances. The proposed regulations would respond to this petition by allowing

• I K licensees the discretion to permit visitors to receive up to 500 milliremp'irr ym. from exposure to harp!t-!!nd radietierIpatien %hL //3 p M M tocpc 3e 7g, x

! In addition, the proposed changes add a requirement for reporting unintended radiation exposure of an embryo, fetus, or nursing child, and add specific requirements for medical uses of radiation by a licensee at temporary job sites and for specific

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Offu,fOf t",

MCRCTAi<s-l MEMORANDUM TO. L Joseph Callan Executive Director for Operations L

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Annette L. Vietti-Cook. Acting Secretary FROM:

SUBJECT; ST AFF REQUIREMENTS - SECY-98-128 - PROPOSED RULE.

REVISION OF 10 CFR PART 35. MEDICAL USE OF I BYPRODUCT MATERIAL The Commission has approved publication of the proposed rulemaking in the Federal Reaister

~' subject to the comments provided below and the ed torial changes provided in the attachment (SECY Suspense: 8/14/98 (EDO)

1. -In response to the request by the Advisory Committee on the Medical Uses of isotopes and numerous other stakeholder. the comment penod for this proposed rule should be extended to 90 days. The staff could delay finalization of the Medical Use Policy j Statement and related guidance documents until after promulgation of the final rule to accommodate the extended comment period.

2.- Specific comment should be requested on the proposed changes which impact the Radiation Safety Committee (RSC) and the licensee's effectiveness in carrying out radiation protection programs: Since the current revision requires that the Radiation Safety Officer (RSO) acknowledge responsibihty for the radiation protection program in writing, specific comment should also be sought on 1) whether this combination of changes in the proposed revision may actually reduce the effectiveness of radiation protection programs, 2) whether the rule language should be modified to explicitly require that the RSO be a member of any committee responsible for overseeing the radiation protection program in the event that the proposed requirements are fundamentally retained, and 3) whether the RSO will be provided appropriate tools and channels through which to raise safety concerns to the highest levels under the proposed revision.

3.-

The training and experience requirements for the therapeutic use of iodine-131 for treatment of hyperthyroidism and thyroid cancer do not appear justified based on the lack of a history of radiation safety problems with these uses. The staff should provide a more thorough explanation of its basis for raising the number of training hours for each category of use in the FRNL in addition, the staff should remain abreast of the evolving technology in the field of intravascular brachytherapy to ensure radiation safety requirements including training L and experience for users and the use of the team approach and its composition.

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appropnately reflect the nsk associatec w1:n these procedures When submitting the final rule package to the Commission. the staff should provide more detailed information on the FTE effort that will be required to implement the third party examination process for the adequacy of hcensee training and expenence and schcit specific public comment on the need for this additional regulatory layer

4. The new requirement for cahbration of all brachytherapy sources by the licensee before initial use should be revised to allow cahbration by the manufacturer traceable to NIST or other recognized bodies as an acceptable means of meeting the requirement of the proposed rule unless the staff can provide evidence that there have been problems with manufacturers cabbration in the FRN. Specific public comments should be sought on this area of the proposed rule. If the requirement remains as proposed, the staff should solicit comments on whether significant increases in licensees' facthfies or equipment

.JI be needed to comply with t" proposed requirement.

5.

The new requirements regarding precursor events should be deleted from the proposed rule. The staff should use an information Notice to aleri ficensees to existing requirements and reinforce the need for comphance with these requirements in its inspection and enforcement activities.

6.

The Commission continues to support the requirement for patient notification of medical events.

7. The Commission is concerned that the proposed phrase in item 35.3045(e)(2),

"provided a statement is included that the report submitted to the NRC can be obtained from the licensee," is unnecessary. This phrase should be deleted since item 35.3045(e)(1) provides licensees the flexibility to furnish the patient with the report

, submitted to NRC.

! The new requirement for reporting to the NRC of any dose to an embryo / fetus or nursing child greater than 5 mSv should include a requirement to notify the mother at the discretion of the refernng physician. The requirement in S35.3047 for reporting of I certain doses to the embryo / fetus or nursing child should not necessarily be limited to As such, medicallicensees, but should apply to alllicensees pursuant to Part 20.

j while retaining this provision in 35.3047, the broader issue should be addressed in a rulemaking separate from this rulemaking.

8.

The staff should continue to review the proposed record keeping requirements to determine if there are any that could be deleted, and if so, specifically solicit comment on those requirements. For example, the requirement in S35.2063 to keep records of unsealed patient dosages of byproduct matenal does not exempt " low-risk" dosages administered pursuant to 535.100 or $35.200 which are not required to be assayed.

9 The Federal RegSig,r notice should be changed to reflect the following proposed requirements and specific comments should be sought on them

a. 10 CFR 35.12(c) - While the proposed rule language reflects the current practice of issuing bcenses for teletherapy and gamma radiosurgery separately from other medical uses, the basis for this approach should be briefly explained in the statement of considerations.

b. 10 CFR 35.13(a) - The staff should consider changing the words, " clinical procedure' to ' type of use" or similar verbiage to more accurately reflect that types of use are authorized on the license and not specific clinical procedures.

c. 10 CFR 35.13(e) and (f) - the staff should ensure that the distinction between authorized areas / areas of use (e g , buildings, rooms) and address / address of use (e.g. mailing address) made in these items is clear

d. 10 CFR 35 390(b)(1)(ii) - This item should be modified to add the text from the propose item $35.390(b)(2) into 35 390(b)(1;(ii) as item (F) so as to make it clear that the required five case studies can be done concurrent with the required 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of practical training required by $35.390(b)(1)(ii). Conforming changes are necessary to renumber the remaining section items.

e. 10 CFR 35.51 - The proposed list of medical physics tasks contains a reference to 35.634; however, the proposed rule contains no such section. The missing section should be provided or the typographical error corrected.

Attachment:

As stated cc: Chairman Jackson Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OCA OlG

- Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

PDR ,

DCS i

1

Editorial Changes to the Attachments to SECY-98-128

1. Changes to the Federal Register notice

a. On page 1, in the Summary paragrapn. line 5. insed to workers. patients and the public' after 'tiskJ In line 6. insert more' after 'andJ At the end of line 8. add for public comment '

b. On page 5, paragraph 1, add a new ser,tence at the end: 'The use of byproduct material represents only a small fraction of all medical uses nationwide of radionuclides or sources of radiation. e g , X-ray.' In paragraph 2. line 2, insert

'desenbed' after 'are.' In paragraph 2, line 3, insert 'Approximately' at the beginning of the sentence. In paragraph 3. line 4. replace ' Project' with initiative.'

The

c. On page 12, paragraph 3. line 9. after ' workshops' insert a new sentence:

NRC received approximate:y 330 letters providing input te the rulemaking process.

d. On page 17, paragraph 2. line 1. delete were unanimous in' and change

' concluding' to ' concluded.'

e. On page 25, final paragraph, line 6. replace 'is qualified' with 'has met the requirements.'

f. On page 50, paragraph 3, delete line 1 and replace it with: 'As a result of the NRC's Strategic Assessment and Rebaselining efforts, the staff formed the l

Nuclear Byproduct Material Risk Review Group to develop a risk-informed.

graded approach to regulating many material uses, including medical. The group's final recommendations are expected in the fall of 1998 and will be  ;

considered by the staff during the Part ?5 rulemaking process / At the end of l

paragraph 3, add: 'The draft proposed rule reflects numerous changes from the existing requirements which reduce the regulatory burden to the average licensee /

g. On page 54, paragraph 2, line 3, insert for members of the public exposed to patients released pursuant to @35.75' after limit.' in line 4, insert 'for visitors of confined patients' after ' limit.'

t

h. On page 63, paragraph 1, line 3, insert for diagnostic purposas' after 'used ' in l line 4, insert 'any' after ' apply to.' in paragraph 2, line 9. insert ' prior to such change in ownership' after ' amended.'

l. On page 137, paragraph 1,line 6. insert 'not have been aware of the pregnancy or may' after 'may.'

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2. Changes to the Congressional letters.

a. In paragraph 1, line 1. delete the comma. In line 3, insert 'is' after 'rulemakingf

b. In paragraph 2, hne 5, delete the regulations' and insert 'to workers, patients and the public' after ' risk.' In line 6, delete ' subsequent ' Jn line 8, insert 'for public comment' after ' published.'

c. In paragraph 3, line 5, insert ' including the NRC's Advisory Committee on Medical Uses of isotopes' after ' language ' In line 8, insert ' facilitated' after

' convening / in line 10, add after ' comments: 'which have been incorporated into the proposed rule. The staff has scheduled additional public meetings to solicit input prior to finalizing the rule.'

3. Changes to the draft press release:

a. On page 1, paragraph 1, line 3, insert more' after 'and? In line 4, insert 'to workers, patients and the public' after ' risk /

b. On page 1, paragraph 2, line 1, replace ' radioactive' with ' byproduct' and insert

'and radsation from byproduct material' after ' material.' In line 2, change the period to a comma and replace 'The materialis administered to' with 'for.'

c. .On page 1, paragraph 3, line 2 insert 'beyond the normal rulemaking process after %put,' At the end of the paragrapn, add 'as early as January of this year.'

d. On page 1, paragraph 4, line 2, insert 'more' after ' regulations /

e. On page 4, paragraph 3, lines 6 and 8, delete the 's' on ' millirems / In line 9.

replace 'to hospitalized radiation' with 'a' and delete the 's' on ' patients' and add at the end 'who could not be released pursuant to 10 CFR 35.75.'

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