ML20206E745
| ML20206E745 | |
| Person / Time | |
|---|---|
| Issue date: | 11/06/1984 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Jennifer Davis, Harold Denton, Deyoung R, Minogue R, Norry P NRC OFFICE OF ADMINISTRATION (ADM), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), Office of Nuclear Reactor Regulation, NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| References | |
| NUDOCS 8606240003 | |
| Download: ML20206E745 (400) | |
Text
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f # **S UNITED STATES
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% ,/ NOV 0 61984 MEMORANDUM FOR: Robert B. Minogue, Director Office of Nuclear Regulatory Research John G. Davis, Director Office of Nuclear Material Safety and Safeguards Harold R. Denton, Director Office of Nuclear Reactor Regulation Richard L. CoYoung, Director Office of Inspecticn and Enforcement Patricia G. Norry, Director Office of Administration FROM: William J. Dircks s Executive Director for Operations
SUBJECT:
CONTROL 0F NRC RULEMAKING By memorandum of February 13,1984, " Control of NRC Rulemaking by Offices Reporting to the EDO," Offices were directed that effective April 1,1984, (1) all offices under ED0 purview must obtain my approval to begin and/or continue a specific rulemaking, (2) resources were not to be expended on rule-makings that have not been approved, and (3) RES would independently review rulemaking proposals forwarded for my approval and make recommendations to me concerning whether or not arid how to proceed with the rulemakings.
q In accordance with my directive, the following proposals concerning rulemaking have been forwarded for my approval along with recommendations from RES con-cerning the proposals:
- 1. Proposed revision of 10 CFR Part 35, Human Use of Byproduct Material.
(Sponsored by NMSS - memorandum, Minogue to ED0 dated August 30,1984.)
Continuation of this rulemaking is approved.
- 2. Proposed amendments to 10 CFR Part 50 (Domestic Licensing of Production and Utilization Facilities) concerning communications procedures; e.g.,
NRC addresses and number of copies for required reports. (Sponsored by ADM - memorandum, Minogue to EDO dated October 4,1984.) Continuation of this rulemaking is approved.
- 3. Proposed amendments to 10 CFR Parts 19, 21, 30, 40, 50, 70, 71, 73 and 110 to provide specific authority relative to the copying of licensee physical security records and to specify retention periods for physical security QDio2NboD3 841/blo O Em iT PbR
records. (Sponsored by RES - memorandum, Minogue to ED0 dated October 12, 1984.) The sponsoring office has decided to terminate this rulemaking and I agree with this decision.
- 4. Proposed amendments (ANPRM) to 10 CFR Part 70 (Domestic Licensing of Special Nuclear Material), to codify licensee physical inventory reporting.
(Sponsored by RES - memorandum, Minogue to EDO dated October 22,1984.)
Continuation of this rulemaking is approved.
- 5. Proposed new rule (ANPRM) 10 CFR Part 39 coqcerning well-logging operations.
(Sponsored by RES - memorandum, Minogue to EDO dated October 22,1984.)
Continuation of this rulemaking is approved.
- 6. Proposed amendments to 10 CFR Parts 30 and 32 concerning format and editorial changes to the regulations. (Sponsored by RES - memorandum, Minogue to ED0 dated October 29,1984.) The sponsoring office has decided to terminate this rulemaking and I agree with this decision.
The NRC Regulatory Agenda (NUREG-0936) should be modified to reflect the status of items 1-6 above.
Although this process for review of rulemaking has not progressed at the rate I had anticipated, from the feedback I have received and the results I have observed to date, I believe it to be a cost effective process and I am committed to its successful implementation.
I note that the most recently published NRC Regulatory Agenda contains about 100 rules so we have a long way to go. In this regard, I ask that the Office Directors ensure that appropriate procedures within their offices have been fully implemented.
Willia . Dircks Executive Director for Operations cc: V. Stello J. Roe
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( MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director =
Office of Nuclear Regulatory Research
SUBJECT:
CONTROL 0F NRC RULEMAKING: RES INDEPENDENT REVIEW 0F ONG0ING RULEMAKING SPONSORED BY NMSS 1
l Based on our independent review of the ongoing rulemaking, " Human Uses of l Byproduct Material--Revisions to 10 CFR Part 35," sponsored by NMSS, RES agrees with the recommendation of the Director, NMSS, that this rulemaking effort should continue.
The basis for our recommendation is as follows:
1 This specific ongoing rulemaking would consolidate requirements dispersed in 10 CFR Part 35, standard conditions for specific licenses authorizing human use of byproduct material, branch positions, and certain regulatory guides that apply to institutions and physicians licensed for the interr.61 or external administration of byproduct material, or the radiation therefrom, to human beings. The consolidation of widely dispersed requirements would:
o Result in a greater degree of safety along with cost savings by not requiring a license amendment every time a procedure is changed.
o Reduce confusion on the part of the licensee by codifying all the requirements in one place.
o Promote uniformity among regional offices in issuing licensing documents and inspecting licensees for compliance with regulatory requirements and license conditions.
o Eliminate the practice that the license require, as a condition, that the licensee follow the statements and representations (including those not related to health and safety) set forth in the application for license and any supplement to it.
The complete RES independent review package has been sent to OEDO (Attention:
DEDR0GR) and to the Director, NMSS. This package includes some suggested wording changes in the rulemaking package which we believe will improve the quality of the supporting documentation for the proposal.
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Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
As stated
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ENCLOSURE C Results of RES Staff Review h
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RESULTS OF RES STAFF REVIEW I. Introduction The subject rulemaking is a proposed revision of 10 CFR 35, " Human use of Byproduct Material." NMSS prepared an earlier proposal which was described in SECY-83-62 and presented to the Commission. The present version reflects guidance from the Commission to the staff on that earlier proposal, as well as additional comments from headquarters and regional staff and from the Agreement States. Comments by the Division of Radiation Programs and Earth Sciences on the latest version were provided in a May 10, 1984 memorandum. Norman McElroy, the NMSS contact, has discussed our comments in detail and resolved them to our satisfaction.
II. Quality Control Review A check of the package submitted by NMSS against the documentation requirements specified in II.C.I. of the " Procedures for Conducting RES Independent Rule of Rulemakings," revealed that several documents were missing. Norman McElroy provided the Periodic and Systematic Review (Enclosure 3), the Regulatory Analysis (Enclosure 4), the Environmental Impact Analysis (Enclosure 7), a summary table of comments on content of SECY-83-62 regulation (Enclosure 8),
and a summary table of human use licensee citations issued in 1982 (Enclosure 9); copies are attached for the RES Independent Review Board. At this stage of. development it is not necessary to examine the draft public announcement or the draft congressional letter.
The Regulatory Analysis was reviewed using the criteria outlined in " Contents and Format for the Regulatory Analysis" of NUREG/BR-0058. The regulatory analysis was very well-written and addressed all six requirements in Section III.B. Especially noteworthy was the table developed to estimate the burden on six hypothetical licensees of complying with each individual section of the proposed regulation. This table with accompanying discussion contains the basic information collection burden estimates required by the Paperwork Reduction Act and the economic impacts on small entities required by the Regulatory Flexibility Act. A complete OMB Statement has been prepared in accordance with draft NRC appendix 0230; it was spot-checked and appeared comprehensive. The Cost Analysis Group (CAG) reviewed the cost analysis section of the Regulatory Analysis and provided comments in their April 6,1984 memorandum; all comments have been resolved.
The Environmental Impact Analysis (Environmental Assessment - Finding of No Significant Impact) was reviewed using 10 CFR 51, " Licensing and Regulatory Policy and Procedures for Environmental Protection." The specific impacts discussed were exposure of the public resulting from release of patients containing radiopharmaceuticals or permanent implants, mobile service transportation, storage of volatiles and gases, and exposure of the ecosystem.
The discussion of why none of these will result in any significant impact on the environment was technically sound and well-presented.
The RES Independent Review procedures state that CRGR guidelines apply only to requirements imposed on one or more classes of power reactors. NMSS rulemaking concerning medical licensees is therefore exempt from CRGR review.
III. Evaluation of Rulemaking Proposal a) Issue to be addressed.
NMSS is proposing a complete revision of the regulations for licensing the intentional irradiation of humans by medical practitioners. These regulations are codified in 10 CFR 35, " Human Use of Byproduct Materials."
b) Necessity and urgency for addressing the issue.
At the present time the requirements that apply to human use are dispersed throughout the existing Part 35, standard license conditions, branch policy positions, and regulatory guides. The proposed revision will codify all the requirements in one place, thus reducing confusion on the part of the licensee and promoting uniformity among the Regions in licensing and inspection. Also by codifying the requirements, it will not be necessary to tie the licensee to all statements made in his application including those not related to health and safety. This will allow greater flexibility and reduce the number of requests for amendments.
The urgency for revising Part 35 results from the fact that an earlier version was presented to the Commission in SECY-83-62. The Commission directed the staff to revise it and resubmit it for their review.
c) Alternative to rulemaking.
There is really only one alternative, and that is to do nothing. The present system, while cumbersome, is workable, d) How the issue will be addressed through rulemaking.
As noted in (b) above, the revision will codify all the requirements for medical use in the regulation itself, e) How the public, industry, and NRC will be affected.
Because no additional requirements will be imposed, no economic burden will be imposed on the licensee (or be passed on to the public as increased costs for medical treatment). On the contrary, the resulting flexibility will reduce licensee costs and NRC staff time for amendments.
Regarding protection of the public and worker health and safety there will be no change since the requirements will be the same as those presently imposed, but dispersed throughout various sources.
f) NRC resources and scheduling.
l Most of the resources have already been expended in preparing the first version for the Commission, in incorporating the Commission's directives, I
2
and in responding to comments from other NRC offices and licensees. NMSS hopes to issue a Notice of Proposed Rulemaking by the end'of August 1984.
Analysis of public coments submitted during the coment period and preparation of the final rule will require substantial staff effort.
IV. Additional Discussion Item-Mobile Nuclear Medical Services Ref: Congressional Letter from MASI
Background:
Disgnostic radiopharmaceuticals are reconstituted in multi-dose vials from which the user can draw a single dosage. Current licensing policy allows mobile nuclear medicine services to transport both unit dosages and multi-dose vials for use at client facilities.
Events: :In an earlier draft the drafting comittee proposed to restict mobile services to transport of unit dosages because it was assumed that they were inherently safer in case of an accident. During the NRC and Agreement State coment period that ended March 30, several individuals pointed out that both were safe, and there had been no problem with current policy. Also, one licensee who had obtained the draft called an NRC license reviewer and said: (1) if a client has an extra patient, there would be no pharmaceutical available; and (2) if the mobile service arrived early or late, the unit dosage may be outside the prescribed dosage range due to radioactive decay.
The markup draft was changed, in response to these coments, to allow mobile services to transport multi-dose vials.
3
j#"% UNITED STATES
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'% ,' , ,," , J AUG 3 01984 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES INDEPENDENT REVIEW 0F ONG0ING RULEMAKING SPONSORED BY NMSS Based on our independent review of the ongoing rulemaking, " Human Uses of Byproduct Material--Revisions to 10 CFR Part 35," sponsored by NMSS, RES agrees with the recomendation of the Director, NMSS, that this rulemaking effort should continue.
The basis for our recommendation is as follows:
This specific ongoing rulemaking would consolidate requirements dispersed in 10 CFR Part 35, standard conditions for specific licenses authorizing human use of byproduct material, branch positions, and certain regulatory guides that apply to institutions and physicians licensed for the internal or external administration of byproduct material, or the radiation therefrom, to human beings. The consolidation of widely dispersed requirements would:
o Result in a greater degree of safety along with cost savings by not requiring a license amendment every time a procedure is changed.
o Reduce confusion on the part of the licensee by codifying all the requirements in one place.
o Promote uniformity among regional offices in issuing licensing documents and inspecting licensees for compliance with regulatory requirements and license conditions.
< o Eliminate the practice that the license require, as a condition, that the licensee follow the statements and representations (including those not related to health and safety) set forth in the application for license and any supplement to it.
The complete RES independent review package has been sent to OEDO (Attention:
DEDROGR) and to the Director, NMSS. This package includes some suggested wording changes in the rulemaking package which we believe will improve the quality of the supporting documentation for the proposal.
b-Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
As stated
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JUL 2 71984 MEMORANDUM FOR: Robert B. Minogue, Director Office of Nuclear Regulatory Research FROM: Robert M. Bernero, Chairman RES Independent Review Board
SUBJECT:
MINUTES OF RIRB DELIBERATIONS FOR ONG0ING RULEMAKING SPONSORED BY NMSS The rulemaking review package received June 1, 1984 (Mail Control
- RES-841230A), states
...the Office of Nuclear Material Safety and Safeguards l has reviewed the on-going rulemaking activities listed below. On the basis of our review, we recommend the !
approval of continued activity on these rules." l Enclosed is the draft independent review package as prepared by responsible RES staff and considered by the RES Independent Review Board.
Also enclosed are the voting sheets of the RIRB members that reflect their deliberations. As indicated, the RIRB members voted 4 to 0 that the NRC should proceed with " Human Uses of Byproduct Material - Revisions to 10 CFR Part 35," sponsored by NMSS. By their concurrence in these minutes, the RIRB members recommend that the RES independent recommendation read, as proposed by one RIRB member, as follows:
1 Although RES agrees that NRC should proceed with this ongoing !
rulemaking, the Commission paper and supporting documents such as j the regulatory analysis should be modified to state that this i consolidation of widely dispersed requirements will result in a greater degree of' safety along with cost savings by not requiring a license amendment every time a procedure is changed. The Commission paper, as now written, would indicate that there is little incentive for continuing on with this rulemaking since it states on page 9 of the Commission paper that the effect of i
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JUL 2 71984 selecting the recommended alternative would be that the staff does not expect any change in worker or public dose or signifi-cant cost or savings.
N Robert M. Bernero, Chairman RES Independent Review Board
Enclosures:
- 1. Draft independent review package for
" Human Uses of Byproduct Material-Revisions to 10 CFR Part 35"
- 2. Voting sheets of RIRB members
RES INDEPENDENT REVIEW BOARD VOTING $HEET TO: ROBERT M. BERNER0, CHAIRMAN, RIRB FROM:
TITLE OF RULEMAKING: " Human Uses of Byproduct Material - Revisions to 10 CFR Part 35" (soonsored by NMSS)
AGREE WITH DRAFT RES REQUEST RIRB INDEPENDENT RECOMMENDATIONS MEETING.
IN DRAFT INDEPENDENT REVIEW PACKAGE.
MODIFY DRAFT RES NOT PARTICIPATING.
X INDEPENDENT RECOMMENDATIONS AS INDICATED BELOW.
COM ENTS AND SUGGESTIONS:
Although P.ES agrees that NP.C should proceed with this ongoing rulemaking, the Commission paper and supporting documents such as the regulatory analysis should be modified to state that this consolidation of widely dispersed requirements will result in a greater degree of safety along with cost savings by not requiring a license amendment every time a procedure is changed. The Commission paper, as now written, would indicate that there is little incentive for continuing on with this rulemaking since it states on page 9 of the Commission paper that the effect of selecting the recommended alternative would be that the staff does not expect any change in worker or public dose or significant cost or savings, y
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- 0. E. Bassett /
RES INDEPENDENT REVIEW BOARD VOTING SHEET TO: ROBERT M. BERNERO, CHAIRMAN, RIRB FROM:
TITLE OF R'JLEMAKING: " Human Uses of Byproduct Material - Revisions to 10 CFR Part 35" (r,oonsored by NMSS)
, AGREE WITH DRAFT RES REQUEST RIRB INDEPENDENT RECOMMENDATIONS MEETING.
IN DRAFT INDEPENDENT REVIEW PACKAGE.
MDDIFY DRAFT RES NOT PARTICIPATING.
INDEPENDENT RECOMMENDATIONS AS INDICATED BELOW.
COMMENTS AND SUGGESTIONS:
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MEM ER, RIRB t , vM
'I DATE' j
f RES INDEPENDENT REVIEW BOARD VOTING SHEET TO: RIRB FROM:
TITLE OF RULEMAKING: " Human Uses of Byproduct Material - Revisions to 10 CFR Part 35" (noonso[rdbyNMSS)
AGREE WITH DRAFT RES Y INDEPENDENT RECOMMENDATIONS IN DRAFT INDEPENDENT REVIEW REQUEST RIRB MEETING.
PACKAGE.
MDDIFY DRAFT RES NOT PARTICIPATING.
INDEPENDENT RECOMMENDATIONS AS INDICATED BELOW.
COMENTS AND SUGGESTIONS:
MEM ER, RIRB 7 - [dV DATE l
JUL 0 21984 RES INDEPENDENT REVIEW BOARD VOTING SHEET TO: ROBERT M. BERNER0, CHAIRMAN, RIRB FROM: /([r/ 8 fo//ep TITLE OF RULEMAKING: " Human Uses of Byproduct Material - Revisions to 10 CFR Part 35" (soonsored by NMSS)
AGREE WITH DRAFT RES REQUEST RIRB X INDEPENDENT RECOMMENDATIONS IN DRAFT INDEPENDENT REVIEW MEETING.
PACKAGE.
MDDIFY DRAFT RES NOT PARTICIPATING.
INDEPENDENT RECOMMENDATIONS AS INDICATED BELOW.
CODMENTS AND SUGGESTIONS:
MEPEER, RIRB s/a8/u DkTE
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BUN 2 2 1984 MEMORANDUM FOR: James C. Malaro, Chief Regulatory Analysis and Materials Risk Branch Division of Risk Analysis and Operations, RES FROM: Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
SUBJECT:
RES INDEPENDENT REVIEW 0F ONG0ING RULEMAKING As requested by your June 8,1984 memorandum, the NMSS package, " Human Uses of Byproduct Material" Revision to 10 CFR 35, was assigned to the Health Effects Branch for review.
The draft staff recommendation is that NRC should proceed with the specific ongoing rulemaking. One item, involving addition of materials not yet approved for licensing, is suggested for further consideration.
Enclosed is our draft independent review package. The RES task leader is Judith D. Foulke, x74563.
n/fddL Karl R. Goller, Director Division of Radiation Programs
- and Earth Sciences, RES
Enclosures:
A. Rulemaking review package received from NHSS B. Draft staff recommendations C. Results of RES staff review cc: R. Cunningham, NMSS l
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//$fl Distributien w/o runcl.
RES Central Files Circ /Chron RAMRB/r/f/
RMinogue MErnst JMalaro JUN 8W JHenry RES Mail Control No. RES-841230A MEMORANDUM FOR: Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES FROM: Robert M. Bernero, Chairman RES Independent Review Board
SUBJECT:
CONTROL OF NRC RULEMAKING: RES INDEPENDENT REVIEW 0F ONG0ING RULEMAKING Enclosed is a rulemaking review package received from a sponsoring office for RES independent review. (Enclosure 1)
In accordance with procedures approved by the EDO on May 30, 1984, the rulemaking review package is assigned to your Division for action. (Enclosure 2)
The ED0-approved pracedures allow a total of 20 working days for completing the RES independent review. To assist RES in completing its independent review in a timely manner, please submit the draft independent review package for this specific rulemaking to RAMRB by 5 working days from the date of this memoran-dum.
Original sigmd by Malcolm L Emn Robert M. Bey o, Chainnan RES Independi ew
Enclosure:
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- 1. Human Uses of Byproduct Material - Revisiolseg,4 N r ::,
10CFR Part 35 jf % G,
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- 2. Procedures for Conducting RES #* -
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ENCLOSURE A Rulemaking Review Package Received From NMSS I
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%.... / MAY g MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: John G. Davis, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
CONTROL 0F NRC RULEMAKING - EDO INITIAL REVIEW In response to your memorandum of February 13, 1984, and in accordance with instructions provided in subsequent memoranda from the Office of Nuclear Regu-latory Research (RES), the Office of Nuclear Material Safety and Safeguards has reviewed the on-going rulemaking activities listed below. On the basis of our review, we recommend the approval of continued activity on these rules.
REVIEWED BY NMSS FOR EDO INITIAL REVIEW A. " Human Uses of Byproduct Material - revisions to 10 CFR Part 35"
- 8. " Radon and Technetium Estimates for Table S-3" C. " Reporting Requirements for Safeguards Events" D. " Physical Protection Requirements for Independent Spent Fuel Storage Installations" E. " Material Control and Accounting Requirements for Low Enriched Uranium Facilities" F. " Clarification of General thysical Protection Requirements" I WLA John G. Davis, Director Office of Nuclear Material Safety and Safeguards
Enclosures:
Review Packages for the above listed rulemaking activities cc w/ encl: RES RM 841230 i
i
. _ ._. . _ _ _ __ -_- ._._ _. _ . _ _ _ . . _ _ . ~ .
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DIVISION OF FUEL CYCLE AND MATERIAL SAFETY i
! " Human Uses of Byproduct Material - 10 CFR Part 35" Division
Contact:
Norman McElroy
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TITLE: .
Human Uses of Byproduct Material -
CFR CITATION:
10 CFR 35 ABSTRACT:
The present regulation is incomplete and hard to interpret; it needs a thorough revision and reorganization. The proposed rule would also revise certain requirements and procedures that apply to the use of byproduct material for patient care. For example, NRC's approximately 2500 specific medical licenses now contain a license condition requiring measurement of the activity of radiopharmaceutical dosages before administering them to patients. The proposed rule would replace this condition in all specific medical licenses with a regulation requiring measurement of activity in the radiophannaceutical and recording of the patient dosage.
Since the current regulation needs extensive reorganization and rewriting, the NRC did not consider any alternative other than a complete revision. The proposed rule will maintain the current level of radiation protection for medical workers, patients, and the public. Based on a cost analysis of the regulation as it would apply to representative medical licensees, the NRC does not expect any significant savings or additional expenses for affected persons. This cost analysis will be made available to the public.
TIMETABLE:
NPRM 08/31/84 LEGAL AUTHORITY:
42 USC 2111; 42 USC 2201; 42 USC 2232; 42 USC 2233 CFFECTS ON SMALL BUSINESS AND OTHER ENTITIES: Yes AGENCY CONTACT:
Norman L. McElroy Office of Nuclear Material Safety and Safeguards Washington, DC 20555 301 427-4052
OFFICE FINDINGS ON PR0o0 SED RULEMAKING 10 CFR PART 35
- 1. Issue The current regulation covering " Medical Licenses for Human Uses of Byproduct Material" is incomplete and hard to read. The purpose of the proposed rulemaking is to codify all medical license require-ments in the regulations. The principle issue is the need for regulatory control by license condition in addition to control by regulation.
- 2. Need The need t'or the proposed rulemaking is based on the fact that the current regulatory system is not clear to licensees and is time-consuming for both licensees and NRC licensing and inspection staff.
The urgency is based on the fact that the Commissioners are expecting a submission.
- 3. Alternatives Since the current regulation is incomplete and hard to read, the staff did not consider any alternative other than a complete revision.
- 4. Proposed Action There is almost unanimous consensus, and therefore no " issue," that the regulation needs to be revised. Concerning the licensing issue the staff is proposing that any regulatory controls in the license be licensee specific and that all generic controls be in the regulation.
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- 5. Effects of Proposed Action The benefit to all will be an easy-to-read, complete standard.
Since the rulemaking is essentially codifying current practice, the staff does not foresee any change in worker or public exposure, or any change in licensee costs. There might be a small savings of NRC licensing and inspection time.
6.. Resources and Schedule NRC resources: 1.5 staff years Planned schedule of rulemaking steps:
Distribute SECY paper and Regulatory Guide 10.8 for NRC and Agreement State comment 2/28/84 Comment period closes 4/30/84 Distribute paper and Regulatory Guide for Concurrence 6/15/84 Concurrence /non-concurrence due 6/30/84 Forward paper and Regulatory Guide to EDO 7/15/84
- l :q ORAFT MEMORANDUM FOR: William J. Oircks -
Executive Director for Operations FROM: John G. Davis, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
PROPOSED REVISION OF PART 35 The staff has prepared a proposed revision of 10 CFR Part 35, " Human Use of Byproduct Material" for comment. The proposed revision is based on SECY-83-62 anc the Commission's reponse to that proposal. Individuals from NMSS, IE, RI, RII, RIII, RIV, RV, RES, OPE, SP, ADM, ELO. and two Agreement States nelped prepare this proposal.
The following offices have concurred with the proposal, indicating that'they have no objection to publishing the proposed revision for comment: (fill in]
John G. Davis, Director Office of Nuclear Material Safety and Safeguards Enc 1: Proposed revision of 10 CFR Part 35 02/08/84 (McElroy/0 RAFT TRANSMITTAL MEMO)
O b ORAFT COMMISSION PAPER
~
For: The Commissioners From: ~ William J. Dircks, Executive Director for Operations
Subject:
PROPOSED REVISION OF 10 CFR PART 35 " HUMAN USE OF EYPRODUCT MATERIAL" Purcose: To obtain Commission approval of.a notice of proposed rulemaking.
Categorv: This paper covers a significant policy on ifcensing of byproduct materials. '
Xssue: Revision of the human use regulations and change in the method of ,
licensing of human use of byproduct material.
Overview: The phrase " human use" is used to refer to the intentional irradiation of humans by medical practitioners in the practice of the healing arts. The staff is proposing to revise the regulations governing human use and to change the method by which persons are licensed for human use of byproduct material. The staff had prepared an earlier proposal which was circulated as SECY-83-62. This new proposal reflects guid-l ance from the Commission to the staff on that earlier proposal (Enclosure 2), and additional comments from headquarters and regional staff and the Agreement States that were received.
l The NRC issues licenses to both medical facilities and private prac-tice physicians for the use of byproduct materials in medical diag-nosis and treatment of humans. During the past three decades, use has l
Contact:
Norman L. McElroy 427-4052 l 02/09/84 CP 10 CFR 35 l
l
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The Commissioners 2 j l
l grown annually at a rate of about 15 percent. There are currently about 2200 hospitals and 400 private practica physicians who are NRC licensees. In 1981, NRC staff received 73 applications for new ifcenses, 224 renewal applications, and 1,303 amendment applications for a total of 1,620 requested licensing actions.
. Most medical institutions and private practice physicians operate under a specific license which authorizes many types of byproduct materials procedures. An application is made on a standard NRC form and supplemented with detailed descriptions of radiation safety proca-dures, personnel qualifications, and facilities and equipment. Each application is reviewed in detail before a license is issued. There are also a few nuclear medicine procedures authorized by general license. A general license authorizes physicians to use small quanti-ties of certain prepackaged radiopharmaceuticals, and is obtained simoly by filing a registration form. Section 35.31 specifies safety measures and possession limits. The NRC staff does not perform a technical review of the registration form but only validates it.
The staff is proposing to simplify the regulatory program for medical licensees. The specific objectives are to:
l Make regulations consistent with well established technology and standards, l
Write all prescriptive requirements in simple English and codify them in the regulations, and l
Assure uniformity among the'ragions in licensing and inspection.
l l Key features of the proposed rule change designed to meet these objectives include:
1 I
-e The Commissioners 3 Consolidation of the requirements that apply to human use that are now dispersed throughout existing regulations, branch policy positions, standard conditions of licenses and regulatory guid-ance into a concise and coherent set of regulations, and Allowance for greater flexibility under the license, thereby reducing the number of amendment requests.
In preparing this proposal, the staff has taken direction from the Commission's policy (Policy and Planning Guidance, 1984, NUREG-0885, Issue 3, page 7 item 2, and page 8 ftem 3) that "...NRC regulations should allow individual licensees the flexibility to select the most cost-effective ways to satisfy NRC safety objectives... Existing regulatory requirements that have a marginal importance to safety should be eliminated..."
Background:
The previous proposal, SECY-83-62, had two key features. The drafting committee tried to incorporate into a single codified regulation all the standards that apply specifically to the human use of byproduct material. The current Part 35, current Regulatory Guide 10.8, and a list of frequently used license conditions served as the principal references. The drafting committee believed that the proposed regula-tion was sufficiently stringent and specific to provide clear guidance and a basis for enforcement action that was not based on statements made by the licensee during the application process. Therefore, as the second key feature, the drafting connittee recommended that appli-cants no longer be required to submit for agency review and approval the detailed, site-specific procedures that would be followed to effect compliance with the regulations. The applicant would merely certify that adequate procedures had been developed. Also since training and experience requirements would now appear in the regula-tions, applicant authorized users would simply be allowed to certify
~
that they met the training and experience requirements.
~' 9 The Commissioners 4 Some individuals on the NRC staff and most of the Agreement State program directors opposed the proposal. Some felt that the regulatory text was incomplete. Many felt that, to assure the public health and safety, it is necessary to review an applicant's procedures for com-pleteness and adequacy.
The Commission directed the staff (Enclosure 2) to revise the proposal, keeping in mind four general directives that are discussed in the following paragraphs.
"(1) The Commission approves the consolidation of the essential safety elements ... into a Part 35 rule." The drafting committee has col-lected and analyzeo technical comments that were received from head-quarters and regional staff and the Agreement States. Many suggestions have been incorporated in the proposed regulation. In many cases the committee did not believe the suggestions could stand the test of need based on public health and safety. A summary table of technic"al comments and their resolution is attached as Enclosure 8.
"(2) The Commission has decided to continue the pre-licensing review of physicians' qualifications ..." The Enclosure 1 preamble has been revised to reflect this directive. The Commission should note that, for the sake of consistency in the proposed regulation, NRC would require pre-licensing review of Radiation Safety Officer qualifica-tions (consistent with current practice), and Qualified Teletherapy Calibration Expert qualifications (contrary to current practice, in which the licensee compares tnat individual's qualifications to the standards in current Part 35). This new requirement should not impose ,
a significant burden on the industry because informal contact with '
regional inspe= tors indicated that roughly 70*.' of these experts hold certification from a specialty board that the staff proposes to recog-nize as evidence of adequate training and experience.
-d j
The Commissioners 5
"(3) The Commission has decided to continue the pre-licensing review of applicants' operating procedures ..." The staff will continue to review procedures submitted in support of an application in order to determine whether they are sufficient to meet the requirements of the regulations. (Consistent with current practice, an applicant will be allowed to simply certify that he will follow a model procedure supplied in Regulatory Guide 10.8 that was developed by NRC with public comment, or will be allowed to submit an alternative procedure
, for review. Many new model procedures have been developed for applicants' consideration.) However, to allow each licensee to make prompt use of new safety methods and to adjust procedures to meet new needs caused by changes in need for patient care services or patient load, licensees will be free to modify their procedures without NRC review or approval as long as they meet the requirements of the regulations. At an institution, the Radiation Safety Committee must review and approve a modified procedure before it may be implemented.
At non-institution facilities, the.RSO and management must review and approve modifications. (This may be compared to technical speciff-cations that apply to reactor licensees. Within the context and requirements of the regulations, licensees would be free to make changes in procedural detail to meet changed operating needs.) A licensee will be cited for failure to meet the requirements of the regulations or license conditions (which would list, for example, authorized users, locations of use, authorized methods of use, authorized byproduct material and inventory limits, and other site-specific limitations), failure to have the written procedures required by the regulations, failure to follow those procedures, failure to have the records required by the regulations, or failure to follow technically valid procedures.
"(4) The staff should clarify how it will imolement the proposed requirements regarding license amencments, while continuing to ensure safety in the licensee's operations." The Enclosure 1 preamole has 02/09/84 CP 10 CFR 35
N The Commissioners 6 been clarified to indicate when a license amendment request must be submitted and what information will be needed to support it. Amend-ment requests will be required for (a) new users (supported by training and experience summaries)
(b) new types of use (supported by all procedures needed for that type of use)
(c) a new method of use (supported by the specific procedure needed for the method of use), and (d) new locations of use (supported by a complete new application if the base of operation changes, or simply the additional address if satellite operations were approved on' the original license).
A section on enforcement policy during the transition period was also added.
Procosai: The staff is suggesting that the Commission publish for public comment a proposed revision of Part 35 and a new method for licensing human use of byproduct material. Three alternative courses for the Commission are discussed below.
Alternative 1: Take no action.
Alternative 2: Publish the proposed revision of Part 35 attached as Enclosure 1.
Alternative 3: Publish the proposed revision of Part 35 after modifying the preamole to require that licensees submit procedural modifications for NRC review and approval.
e The Commissioners 7 Discussion of Alternative 1:
All the individuals who commented on the proposed revision that was submitted in SECY 83,62 agreed that the current Part 35 was in need of revision because it is d!fficult to read and does not contain all the requirements necessary for radiation safety in the human use of by-product materials. The Commission " approved the consolidation of essential safety elements" (Enclosure 2). The staff is not aware of anyone who would recommend retaining the current Part 35 over the proposed revision.
Effect of Selectino Alternative 1:
Because the current Part 35 does not contain all the critical safety elements for human use, the NRC would have to continue to review
- detailed applications and require that licensees follow procedures that were reviewed and approved by NRC. This alternative does not provide any greater degree of safety than the other alternative, but is more costly to both NRC and licensees than Alternative 2, and denies the industry the benefit of a clear, consolidated codification of the i
regulations offered by both of the other alternatives. It is difficult to maintain standardization under this scheme because the legal basis for controlling a licensee is the licensee's appifcation rather than j the regulations.
Discussion of Alternative 2:
l l
The NRC would publish in the Federal Register for comment the proposed regulations and licensing method described in Enclosure 1. An appli-cant would submit: 1. evidence of training and experience, 2. a description of facilities and equipment and 3. procedures, all for pre-licensing review and approval. However, the licensee, would be free to modify facilities and procedures or replace equipment with approval of the Radiation Safety Officer (RS0) and management or at an institution, 02/09/84 CP 10 CFR 35
- y. .u _ ,__m.
N The Commissioners 8 the RSO and the Radiation Safety Committee (RSC) as long as the modi-fications conform with the requirements of the regulations.
Proponents: The proposed licensing method provides for agency review before allowing a program to begin. The implementation of a safe program requires the support of the individuals who have special safety training. If that training is not evident in the key individ-5 uals, the license should not be issued. Issuance of the license should stand as evidence that the agency has found the applicant trained to know safe from unsafe and. legal from illegal, and that the applicant is sufficiently equipped to handle material safely within the scope of use permitted by the license. Licensure would connote that those key individuals are also competent to recognize and imple-ment procedure modifications that provide a level of safety consistent with the requirements of the regulations, and to select replacement equipment and to modify facilities to the extent consistent with those requirements for purpose of improved patient care or safety, or reduced cost. Such modifications could not be made capriciously because they would have to be approved by the RSO and management or the RSO and RSC before being implemented. This method allows the licensee the flexi-bility to meet new site-specific needs. License processing would be compatible with both hard copy and comouter assisted information systems.
Opoonents: Most licensees are small facilities that are staffed by a few authorized user physicians, and technicians who have graduated from a two year formal training program or have been trained at the facility by an authorized user or co-worker. They might employ a part-time consultant who is qualified to review changes on the basis of safety, but that individual may not be aware of the ramifications implicit in a proposed modification because he is not thoroughly familiar with the day-to-day operations. On a private oractice i
license, tne aut'horized user may also be the RSO and management, ano 02/09/84 CP 10 CFR 35
, , -d The Commissioners 9 therefore would be reviewing his own handiwork for safety corside-rations. At an institution the only two individuals on the RSC who are required to have had radiation safety training are the authorized user and RSO, who may be the ones proposing the change. Therefore, in either cage there would be no independent agent required to review modi fications.
Effect of Selectino Alternative 2:
The staff recommends below that the Commission select Alternative 2.
The staff does not expect any change in worker or public dose or significant costs or savings to any entity if the Commission follows r
those recommendations. Rather, the proposal would require some redi-rection of training, and other resources and would probably be per-ceived as a change from the current policy of strict prescriptiveness
, to a policy granting more authority for the licensee who must handle material safely.
A short textual analysis follows for the four groups that would be l affected. A more complete regulatory analysis is attached as Enclosure 4.
1RC l Under the decentralization program now completed, almost all human use
! licensing is now handled by individuals who Iso do inspections. The l
training of these individuals would have to , directed because it now stresses checking the application for completeness and adequacy and then inspecting the licensee for compliance with the application.
Under the proposal the inspectors would have to be trained to recog-c nize, in the field, program elements that do not meet the standards f required by the regulation. The inspector would have to be more thorougnly familiar with the regulation, but would no longer have to 02/09/84 CP 10 CFR 35 l
t
~e The Commissioners 10 familiarize himself with each licensee's procedures before conducting an inspection. This would help to ensure uniformity among the regions.
Since a major goal of the drafting committee was to prepare the state-ment of consideration, regulation, and regulatory guide in plain English, the staff expects fewer deficient applications.
Acreement States AGREEMENT STATES: PLEASE PROVIDE TEXT FOR THIS SECTION.
Licensees The requirements in the proposed regulation were taken from the current regulation, licensing policy, frequently used license condi-tions, and standards recommended in the current regulatory guidance
, followed by many ifcensees. -Thepif' ore, the staff does not expect any increase or decrease in worker dose or any significant cost increase.
There may be some insignificant savings in amendment fees for those licensees who need to modify their procedures. Since more licensing guidance will now be available to the public, licensees may have a clearer understanding of the regulatory process in general and the applicable requirements.
The Public Most man-made non-occupational dose is the result of intentional irradiation of individuals for their own medical benefit under the prescription of a state-licensed physician. Therefore an attempt to reduce public dose would, except in rare circumstances, be a clear intrusion into the practice of medicine. Concerning costs or savings, since they are ultimately borne by the public, because the staff does not foresee any significant changes in day-to-day operations within NRC, the Agreement States, or licensees, the staff does not expect any cost or savings for the public.
-e The Commissioners 11 Discussion of Alternative 3:
The NRC would retain the current licensing method under which an i applicant submits: 1. evidence of training and experience, 2. a description of facilities and equipment, and 3. procedures, all for review, and, when licensed, is required to use byproduct material in accordance with the statements made in the application. The licensee would have to submit all changes in facilities, equipment, and proce-dures for NRC review and approval.
prooonents: The requirement that licensees use material in accord with the procedures in the application provides assurance that licensees have safe procedures available, and provides a clear basis for enforcement action in cases of noncompliance. This is the only way to assure public health and safety. When a question of procedure adequacy or completeness arises, the license reviewer is able to consult reference works or co-workers rather than having to make a quick technical judgment during a field inspection. This also allows
! the license reviewer to ' exercise a certain amount of flexibility to meet each licensee's specific needs. Most Agreement State program directors believe this method of licensing is necessary in order to answer any questions that the applicant or reviewer has, and to resolve any differences of opinion on what is required for compliance. This method may require less extensive training for field inspectors because the inspection is based on compliance with a site-specific step-by-steo radiation safety program.
l Oooonents: The applicant has no public notice beforehand of whether a conservative or liberal reviewer will handle his application or how many rounds of deficiency letter responses will be needed to convince the reviewer that the applicant can handle material safely. Since the licensee is required to use material in accord with the application and letters written in its support, to remain in compliance he may not f
replace any equipment or service contractor or change any facility 02/09/84 Cp 10 CFR 35
-,-d The Commissioners 12 described, or modify any procedure without requesting a license amend-ment. Such a detailed review of an application does not assure safe use, but rather simply existence of adequate facilities, equipment, and procedures; safe use can only be assured by unannounced inspection.
Most citations are not issued for failure to follow a certain pro-cedure or have a particular production model piece of equipment avail-able, but rather for doing nothing when something is required, or doing something that is clearly forbidden. Many experts believe that the critical elements of a medical radiation safety program are well defined and easily codified. Therefore, except in peculiar circum-stances, there is no need to continue with case-by-case regulation. --
This licensing policy may require more extensive training for reviewers and is prone to backlog due to the bulk of material sub-mitted for review and the number of license amendments needed.
Effect of Selectino Alternative 3:
The industry would benefit by having a clear, consolidated set of regulations. The additional requirement to submit changes in facili-ties, equipment, and procedures for NRC review and approval would be costly to both NRC and licensees, but would not be likely to result in a higher degree of safety than that provided by Alternative 2 and would not provide any stronger basis for enforcement actions. Further-more, if the licensee made a determination that a modification would result in safer or more efficient operations, the review and approval requirement would prohibit prompt adoption of the modification. -
Recommendation: The Commission:
- 1. Select Alternative 2. *
. 1 l
l i
-e The Commissioners 13
- 2. Accrove publication of a notice of proposed rulemaking (Enclosure 1) that would describe a new licensing method and would consolidate all human use requirements into 10 CFR Part 35.
i .
Certify that this rule, if promulgated, will not have a negative economic impact on small entities. 'This certification is necessary to satisfy the requirements of the Regulatory Flexi-bility Act, 5 U.S.C. 605(b).
- 3. Note:
- a. The rulemaking would be published in the Federal Register for 60-day public comment period;
- b. The staff conclusions, set forth in Enclosure 3, provide the analysis called for by the Periodic and Systematic Review of Regulations;
- c. Neither an environmental impact statement nor a negative declaration need be made in connection with this rulemaking because it is nonsubstantive and insignificant from the standpoint of environmental impact (Enclosure 7);
- d. The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regard-ing economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act;
- e. The proposed rule contains information collection N requirements
} that are subject to review by OMB. Upon Commission affirma- [
tion, formal request for CMB review and clearance will be initiated; 02/09/84 CP 10 CFR 35
The Commissioners 14
- f. A public announcement (Enclosure 5) will be issued when the proposed rule is filed with the Office of the Federal Recister;
- g. The appropriate Congressional Committees will be informed (Enclosure 6); and
- h. Copies of the Federal Register notice of proposed rulemaking will be distributed to all Commission licensees. The notice will be sent to other interested parties upon request.
William J. Oircks Executive Director for Operations
Enclosures:
- 1. Federal Recister Notice of Proposed Rulemaking
- 2. Memo Chilk to Dircks dated June 23, 1983.
- 3. Periodic and Systematic Review
'/'1 -4 Regulatory Analysis
- 5. Draft Public Announcement
- 6. Oraft Congressional Letter eff v7. Environmental Impact Analysis 9,s - 8. Summary table of comments on content of SECY-83-62 regulation
- jY' 19. Summary table of human use licensee citations issued in 1982
- 10. Draft Regulatory Guide 10.8 Commissioners' comments or consent should be provided directly to the Office of the Secretary by .
Commission Staff Office comments, if any, should be submitted to the Commissioners with an information copy to SECY. If the paper is of such a nature tnat it requires additional time for analytical review and comment, the Commis-stoners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners EDO OGC ELD OPE ACRS SECY ASLBP REGIONAL OFFICES AS LAP OCA OIA 02/09/84 CP 10 CFR 35
-8 ,
, [7590-01]
DRAFT NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 31, 32, 35, and 40 HUMAN USES OF BYPRODUCT MATERIAL AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
SUMARY: The Nuclear Regulatory Commission (NRC) is proposing to revise its regulations to modify the process for licensing medical users of radioactive byproduct material. The proposed revision would primarily affect future NRC licensing actions for hospitals, clinics, and individual physicians.
By clarifying and consolidating all the essential safety require-ments that are now contained in the regulations, license conditions, regulatory guides, and staff positions, the proposed regulation provides a single source of requirements for human use, thereby reducing the administrative burden on the licensee. The proposed regulation also provides the basis for allowing more flexibility in licensees' updating of their day-to-day procedures that would conserve licensee and NRC
- resources. The proposed revision to the regulations would provide a more efficient method for regulating the medical uses of byproduct material.
02/08/84 1 Enclosure 1
-- - - - -v-.,.-,-.w.-y -r -e-, -
y - - ----- - - - - . , - ~ - - - - - - - - - - -
~?
[7590-01]
DATE: Comment period expires (insert 60 days after FRN). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments filed on or before this date.
ADDRESSES: Submit written comments and suggestions to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C.
20555, Attention: Docketing and Service Branch.
Copies of the preliminary regulatory analysis and the comments received may be examined at the Commission's Public Document Room at 1717 H Street NW., Washington, D.C. Single copies of the preliminary regulatory analysis and environmental impact are available from Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Telephone: (301)427-4052.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safegu'ards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Telephone: (301)427-4052.
SUPPLEMENTARY INFORMATION:
BYPRODUCT MATERIAL IN MEDICINE Use for Patient Care Radioactive materials are used in drugs in the field of nuclear medicine. Drugs labeled with radioisotopes are known as radiopharmaceuticals.
02/08/84 2 Enclosure 1 l
- - ~T
[7590-01]
In diagnostic nuclear medicine, patients receive these materials by injection, inhalation, or oral administration. Physicians use radiation detection equipment to visualize the distribution of a radioactive drug within the patient. Using this technology, it is possible to locate tumors and blood clots, assess organ function, or monitor the effective-ness of a treatment. In therapeutic nuclear medicine, larger quantities l~ of radiopharmaceuticals are administered to treat hyperactive thyroid conditions and certain forms of cancer. An estimated 15 to 20 million nuclear medicine procedures are performed in this country annually.
Sealed radioactive sources that produce high radiation fields are used in the field of radiation therapy to treat cancer. A very highly radioactive source can be placed in a taletherapy unit that can be adjusted to direct a radiation beam to the part of the patient's body to be treated. An estimated 2 million teletherapy treatments are performed annually by NRC licensees. Smaller, less radioactive sealed sources are designed to be implanted directly into a tumor area or applied on the surface of an area to be treated. This procedure is known as brachy-therapy. NRC Ifcensees perform approximately 10,000 brachytherapy treatments annually.
Sealed radioactive sources can also be used in machines that are used for diagnostic purposes. The source provides a beam of radiation that is projected through the patient. A device on the other side of the patient detects the amount or distribution of radiation that goes through the patient, which can provide information about tissues within the patient. This is a relatively new development in the field of medicine and the NRC has no estimate of the number of procedures per-formed annually.
02/08/84 3 Enclosure 1
M
[7590-01]
_.- State AFederal Reculation v Me )
twentyyht states, known as Agreement States, have assumed respon-sibility for regulating certain radioactive materials within their respective borders by agreement with the NRC. They issue licenses for human use of byproduct material. In non-Agreement States, the NRC issues licenses to medical facilities and individual physicians. These licenses authorize certain uses of radioactive materials for diagnostic
. and therapeutic medical procedures in humans.
I NRC'S REGULATORY PROGRAM i
l Current Licensina Practica l The current regulations in 10 CFR Part 35, " Human Uses of Byproduct Material," provide for general and specific licenses for human use. The general license in 9 35.31 authorizes physicians to use small quantities of prepackaged individual doses of radioactive materials. Physicians simply submit a registration fom NRC-483 to NRC and a validated copy with an assigned registration number is returned to the applicant.
Most medical institutions and physicians who use byproduct material need more byproduct material than can be safely permitted by a general ifcense. A specific license, which authorizes a larger inventory of byproduct material and a wider variety of uses, may be issued for one or l
more of six types of human use, defined as Groups I-VI in the current 5 35.100. Each group is comprised of a number of diagnostic or thera-peutic procedures that have been grouped together because they require similar radiation safety precautions for safe use. A separate specific license may also be issued for use of a teletherapy unit. All these license applications, which are much more detailed than a general license 02/08/84 4 Enclosure 1
-d o .
[7590-01]
application and actually contain the applicant's step-by-step procedures, - ~ -
are reviewed individually by NRC.
, NRC currently has about 2600 medical licensees. In 1981, the NRC received 73 new applications for specific licenses, 244 license renewal applications, and 1,303 license amendment requests for a total of about 1,600 licensing actions. The NRC has issu'd a 650 general licenses, and in 1981 received five new applications.
To help licensees design their radiation safety programs, the NRC has published many NUREG reports and regulatory guides that contain radiation safety guidance. These publications address three general areas: radiological health and safety, personnel training and exper-ience, and facilities and equipment. Experience has shown that if licensees follow the guidance in the pubitcations the human use of byproduct material generally poses no hazard to workers and the public.
Problems with Current Practice
- The General License. This program is based on the fact that the quantities and forms of material that are authorized by a general license present a very low health risk. Issuing a general license for all in-vivo use of radioisotopes to qualified appifcants would be the simplest approach '
for the NRC and licensees. Unfortunately, it would not assure an acceptable level of safety in the regulated industry.
The NRC also believes it is no longer productive to issue human use general licenses. The tests authorized under 6 35.31 have been super-seded by new in-vitro precedures with more specificity and greater diagnostic accuracy. These developments have been reflected by a significant decrease in appilcations for the general license. As noted 4
02/08/84 5 Enclosure 1 i
M
[7590-01I above, although NRC has on file 650 in-vivo general licenses under i 35.31, only five new applications were received by NRC in 1981.
To determine the status of general license use, the staff performed a telephone survey by attempting to contact 10 percent of the current registrants. The survey indicated that less than 9 percent of the current registrants still use material under a general license; many are now using byproduct material under a specific NRC license. Because of the low level of use of the general license, the NRC has concluded that it no longer serves a useful role in licensing the human use of byproduct material.
The Specific License. Because of the increased potential radiation hazard to workers and the public, the specific license program incor-parates three regulatory features: case-by-case review of applications, on-site inspections, and periodic license renewals.
A major problem with the current licensing program is that radiation protection requirements are not located in one document.
Requirements are scattered in the regulations, Inspection and Enforce-ment (IE) orders that modify a ifcense or group of licenses, and as l
1 conditions attached to individual ifcenses. Suggestions for good practice are contained in NRC regulatory guides and technical reports (NUREG's). For example, Regulatory Guide 10.8, " Guide for the i
Preparation of Applications for Medical Programs," and NUREG-0267,
" Principles and Practices for Keeping Occupational Radiation Exposure at Medical Institutions As Low As Reasonably Achievable," contain many I
recommendations that the NRC believes are critical for the safe use of byproduct material. The revision of Part 35 incorporates those l 02/08/84 6 Enclosure 1 i
[7590-01]
4 recommendations, and also corrects the piecemeal fashion in which the regulations have been amended over the years to address specific problems.
When preparing a specific license aplication for review under the current licensing program, the applicant must include sufficient infor-sation for NRC reviewers to conclude that byproduct material will be used safely. Applicants include, as an integral part of the application package, copies of their proposed step-by-step procedures. In many cases, the procedures are edited versions of procedures described in Regulatory Guide 10.8.
I When NRC receives the application, a licensing reviewer evaluates the applicant's training and experience, facility, equipment, and procedures in detail. If the application is found 'to be incomplete or inadequate, a " deficiency letter" is sent to the applicant explaining what additional information is needed. Review of the appifcation is not resumed until a written response from the. applicant has been received.
Staff studies indicate that about. 40 percent of all applicants receive either a deficiency letter or phone call for additional information because of the conservative licensing and review practices needed due to the incompleteness of the regulations. Deficiency letters are costly for the NRC and the applicant and greatly increase the time required to complete ifcensing actions.
When the application, including any additional submitted infor-mation, is approved, the NRC issues a specific ifcense that grants the authority for human use of byproduct material in accordance with the procedures submitted with the application. Requirements in addition to those contained in tha regulations are frequently incorporated in the ifcense as conditions of use. Since the ifcensee must comply with 02/08/84 7 Enclosure 1
M
[7590-01]
conditions specified in the license, the license, rather than the regulations, is frequently used to regulate radiation s,afety in the day-to-day use of byproduct material.
)
The specific license is valid for five years. The license must be amended before methods of use or procedures may be added or changed, or before adding authorized users. Amendments to a specific license involve an application, review, and approval process similar to that for new li- .
censes. Renewals are treated in the same manner as new lic'ense applications.
s This medical regulatory process was appropriate during the. evolution i
I of the use of byproduct material in medicine. Radiation safety problems were not well defined, regulatory requirements had not caught up with developing technology, and physician training curricula had not been established. Therefore, it was necessary to review each individual radiation safety program to ensure that the applicant had adequate
. personnel, facilities, and equipment.
PROPOSED REVISION OF THE REGULATORY PROGRAM Overview NRC intends to modify its regulation of the medical use of by-product material. The Commission plans to revise the regulations to provide a single source of requirements specifically related to human use of byproduct materials, and within the boundaries set by the regula-l tions, allow medical licensees to modify their procedures, facilities, and equipment so they can make prompt use of new safety methods and also l l
l meet new needs caused by changes in need for various patient care ser-vices or patient load. The proposed revision of 10 CFR Part 35 is I consistant with the Commission's general policy on human use of byproduct i 02/08/84 3 Enclosure 1
"' T
[7590-01]
m_aterial issued February 9, 1979 (44 FR 8242), which states "NRC will continue to regulate the medical uses of radioisotopes, as necessary, to provide for the radiation safety of workers and the general public."
Codification of Recuirements in the Regulations NRC proposes to simplify regulation of medical licensees by incor-porating all human use requirements in 10 CFR Part 35. These requia-tions would become the primary source of requirements for the human use of byproduct material and would serve to regulate the day-to-day uses of radioisotopes for patient care. Licensees would not face significant new regulatory burdens because, in most cases, these requirements cur-rently appear as ifcense conditions which must be met. Under the proposed revision, the ifcense would authorize human use of byproduct materials for specified types of use. Licensees would be regulated by the require-ments for use codified in the regulations. This would simplify inspec-
, tions for NRC because inspectors would only need to be familiar with one set of regulations rather than a different set of license conditions and procedures at each facility.
License Application, Issuance, and Authority and Responsibility The NRC staff will continue to review the procedures submitted by the applicant in order to determine whether they are sufficient to meet the requirements of the regulations. A new revision of Regulatory i
Guide 10.8, " Guide for the Preparation of Applications for Medical Programs," will contain model procedures that the applicant can use to develop site-specific procedures to meet the requirements in the regula-tions. If the applicant's program is incomplete or inadequate, NRC 02/08/84 9 Enclosure 1 i
~e (7590-01I will stop processing the application and will issue a deficiency letter that describes apparent shortcomings in the appiteant's program and requests clarification. Also consistant with current practice, app 11-cants will alternatively be allowed to simply certify that they will follow the model procedure developed by NRC staff and published in i
Regulatory Guide 10.8 to meet a certain requirement.
To allow each licensee to make prompt use of new safety methods and to adjust procedures to meet new needs caused by changes in need for patient care services or patient load, licensees will be free to modify their procedures without NRC review or approval _after_following-an_
internal review and approval process._The right to modify procedure does not relieve the licensee from the requirement to comply with the regulations. At an institution, the Radiation Safety Committee must review and approve a modified procedure before it may be implemented.
At non-institution facilities, the RSO and management must review and approve procedure modifications. This regulatory scheme would not incorporate the current requirements that licensees use byproduct material in accordance with the statements made in the application. This change would bring the regulatory scheme into accord with the general licensing requirements in 530.33(a) which address equipment and facilities and training and experience, but not procedures.
The proposed regulations require specific training and experience for the use of material in each use group. Proposed authorized user (AU) physicians, and Radiation Safety Officers (RS0) and qualified teletherapy calibration experts (QTCE; identified in current Part 35 as
- the Qualified Expert) will have to submit summaries of their training and experience. This is currently required for AU's and RSO's, but 02/08/84 10 Enclosure 1
[7590-01]
would be a new requirement for QTCE's, whose credentials are currently reviewed by the licensee. The staff will review those individuals'
] training and experience against the standards in the regulation before
)
authorizing them to work as an AU, RSO, or QTCE. (Also consistent with l
current practica, any individual who does not meet the standards may ask l for an exemption from the training and experience requirements. The NRC l staff will review the individuals' training and experience with the assistance of its Advisory Committee on the Medical Use of Isotopes, and may issue the exemption as a ifcense condition.)
9 Enforcement Under this regulatory scheme, a ifcensee will be cited for failure to meet the requirements of the regulations or ifcense conditions (which would list, for example, authorized users, locations of use, authorized methods of use, authorized byproduct material and inventory limits, and other site-specific limitations), failure to have on hand the written procedures required by the regulations, failure to follow the procedures on hand, failure to have the records required by the regulations, or failure to follow technically valid procedures. Use of material without
( authorization either by license or by virtuc of working under supervision, would be a violation of the regulations which would subject the individual to an enforcement action.
Amendments As mentioned above, under the current regulatory scheme, the
, licensee is required to handle material exactly according to the pro-l l cedures submitted with the application. The NRC frequently receives 1
02/08/84 11 Enclosure 1
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requests for permission to modify day-to-day operating procedures.
Since the regulations will now contain sufficient prescriptive and performance criteria on which to base enforcement actions, the NRC would allow licensees to modify their procedures. This would eliminate the licensee's need to prepare a formal amendment request for the NRC and l pay an amendment fee in order to make modifications in procedures. This j would g relieve the licensee .from the regulatory requirement to comply l with the regulations in Part 35 or other parts of Title 10.
l Four types of amendments will still be required:
(1) Nw users. The NRC will review the training and experience of each proposed AU, RSO, and QTCE as described above before listing the individual on a license. -
(2) New type of use. Requests to add a type of use (for example, l adding radiopharmaceutical therapy to a license that authorizes radio- .
i
. pharmaceuticals for imaging) to an existing license will be handled as a new application. The AU's training and experience will be reviewed for adequacy with respect to the new type of use, and procedures which must be submitted in support of the request will be reviewed for completeness and adequacy with respect to the new type of use before the amendment is issued.
(3) New method of use. Two types of amendments will be needed:
(a) If a new radioactive material (RAN) becomes available, and the procedures needed for its safe use are identical to the procedures already established for an already established and authorized use (for example, a new imaging agent administered by intravenous injection), the new RAM will be added by rulemaking to the list of materials in the appropriate use group specified in the regulations. The NRC will mail 02/08/84 12 Enclosure 1
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to licensees a notice that says those who are authorized to use material !
I in that group say begin using the new RAM on the effective date of the final rule that adds the new RAM to the regulations. No individual licensing action will be taken.
(b) If a new RAM becomes available but its safe use depends on following a new procedure that current licensees have not submitted and NRC has not reviewed, two actions will be taken.
(i) The new RAM will be added by rulemaking to the appropriate use group in the regulations but authorization to use it will be limited to persons licensed after it was added to the use group. These persons would have submitted the new RAM procedure for review in their appli-cation packages.
(ii) NRC will mail to current licensees a notice that says they may apply for authorization to use the new RAM. With that notice, NRC will also supply a model procedure, which'wculd become a new appendix in Regulatory Guide 10.8, for the new RAM. Those~1icensees who want to use the new RAM will have to submit a request for amendment which includes a proposed procedure that will be reviewed by NRC for completeness and adequacy.
i (4) New location of use. Two types of amendment may be needed:
(a) A request to leave one location of use and begin working in a new location, for example when moving a private practice to a new office or when moving into a new hospital building, will have to be supported by a complete new application package.
(b) Some licensees receive packages, prepare radicpharmaceuticals, and package waste at a central facility, but actually use the byproduct material at satellite locations. This might be a mobile nuclear medicine 02/08/84 13 Enclosure 1
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~
[7590-013 service that provides diagnostic services at clients' facilities such as clinics, small hospitals, or nursing homes, or it may be a licensee that has a principal facility and outlying clinics. If the licensee has been approved to offer service at satellite locations, a request to add another satellite location will only have to identify the new location.
(Due to the training, space, and equipment commitments needed for safety during therapy procedures, the NRC does generally not authorize lican-sees to perform therapies at satellite locations. Such requests will be .
handled on a case-by case basis.)
l Summary of Chances Proposed in the Reculatory Program In summary, the regulation will be amended to require that licensees meet standards that are currently imposed by license conditions. The NRC will continue to review user training and experience. The NRC will review site-specific procedures for completeness and adequacy and issue deficiency letters if necessary, but will allow ~1icensees to modify procedures that were submitted in support of the application if the Radiation Safety Committee, or management and RSO outside an institu-tion, approves the modification. However, the right to modify procedures does not relieve the licensee from the requirement to comply with the l regulations. Amendments will generally be reviewed just as new applica-tions are reviewed, but they may incorporate by reference the original appifcation and any previous amendments.
I 02/08/84 14 Enclosure 1
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NOTES Word Usace In preparing the proposed revision of Part 35, one goal was to remove language that might be misinterpreted. The following words used in the revision may require clarification.
- 1. Type of use and m . In the current Part 35 there are six
" groups" of use described in 5 35.100. Each group is comprised of a set 3
of medical procedures that require similar training and equipment for radiation safety purposes. The word " group" has not been used in the proposed revision in order to avoid confusion between the old and new Part 35. The revision uses the phrase " type of use" for this concept.
Some types of use are amalgamations of old groups, and some types are
.new. The six types of use are: (1) uptake, dilution, and excretion --
Subpart 0; (2) imaging and localization -- Subpart E; (3) radiopharma-cautical therapy --Subpart F; (4) brachytherapy -- Subpart G; (5) sealed sources for diagnosis --Subpart H; and (6) teletherapy -- Subpart I.
- 2. Method of use and procedure. The word " procedure" is frequently used in supporting documentation for byproduct materials programs.
Sometimes it refers to a specific set of steps that must be taken to l effect an end, for example a procedure for ordering and receiving pack-ages. Sometimes it is used to indicate a type of medical examinaton or
, therapy, for example a thyroid uptake study or a cesium implant therapy, l
without indicating the amount of byproduct material used or the specific steps taken in handling it. The word may also be used to indicate the l number of patients cared for over a period of time, for example an l
average workload of fifteen procedures each day. In order to avoid l
02/08/84 15 Enclosure 1
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[7590-01] l i
confusion, the phrase " method of use" appears in the proposed revision.
Each type of use is comprised of several methods of use. Each method of use should identify, explicitly or by context, the radionuclide, its chemical and physical form, method of administration, and purpose (diag-nosis or therapy).
- 3. Oose and dosace. In pharmacy, the word dose is used to indicate the amount of chemical administered; in radiation biology it is used to indicate the amount of ionizing energy absorbed; and in radiation safety it is used to indicate a worker's exposure to radiation. In order to avoid confusion, the word dosage is used in the proposed revision to indicate quantities that are measured with the base unit Curie and the word dose to indicate quantities that are measured with the base unit rad or ren.
- 4. Record and recort. A record is a user-retrievable notation or i
complete document. It may consist of something as small as a check-mark on a form or something as extensive as a survey of a newly installed teletherapy unit with appended calculations to demonstrate compliance with the limits on exposure in uncontrolled areas. A report is a transfer of information which might be made face to face, by telephone, telegram, computer link, or hard copy transmittal.
- 5. Test and check. For many pieces of equipment, drafting committees comprised of industry experts have prepared standards of performance and com'plete calibration protocols. If a piece of equipment is subjected to the protocol in the calibration laboratory and meets all the standards, then the ability of the equipment to perform as expected in normal field use is assured. In the proposed revision this concept of complete examination is referred to as a " test." During field use it 02/08/84 16 Enclosure 1
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is common practice to subject a piece of equipment to a quick examination to determine whether it is operable. This procedure does not examine all parameters of equipment performance. In the proposed revision this concept of perfunctory examination is referred to as a " check."
- 5. Location of use, facility, and area. The phrase " location of use" is used to describe the building or buildings (typically identifying a single street address) where byproduct material is used. The phrase
" facility" connotes a room or contiguous rooms where byproduct material is used, such as a nuclear medicine clinic comprised of an office, an imaging room, and a dosage preparation and waste storage room. The word
" area" connotes the space used by a worker when perfaming a specific task connected with receiving, handling, or storing byproduct material.
, 6. Chemical form. The current regulation requires that if a radiopharmaceutical is used for indications other than described in the package insert, the user must never-the-less follow instructions on chemical and physical form, dosage, and route of administration. The proposed revision has deleted the word chemical in its restatement of this requirement because to change the chemical form would be to create a radiopharmaceutical other than the one received from the authorized distributor. Deletion of this word in the proposed revision does not authorize Part 35 licensees to manufacture radiopharmaceuticals.
- 7. Available for use. In many cases the regulation states an equipment possession requirement becasue the piece of equipment is considered by experts to be an integral part of the radiation safety program. In a few cases the need for a piece of equipment is sporadic and normally scheduled weeks in advance. For example, a licensee who has a diagnostic sealed source in a device (see S 35.500) usually only 02/08/84 17 Enclosure 1
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[7590-01]
needs a survey instrument when receiving or returning a radioactive source; there is no need to have the instrument en hand every day. The phrase "available for use" is intended to connote that the licensee either may possess equipment or contract for measurement services, but is not required to have regular day-to-day possession of the described equipment.
- 8. Operable. The word " operable" is, to some people, conspicuous in its absence from the proposed regulation. If a survey instrument, room monitor, gas trap, or fume hood is not operable, whether due to dead or absent batteries or incomplete or improper maintenac:e, it is no longer a working survey instrument, room monitor, gas trap, or fume hood, and is more appropriately described, for safety purposes, as an assemblage of metal and plastic that once served a useful purpose.
Records Retention The Cometssion requires that licensees make and retain records as evidence of compliance with regulations and license conditions. A review of records during inspections is the least burdensome way that the Commission may be assured that the licensee has developed and implemented a radiation safety program. However, permanent retention of
, all required records, or retention between inspections, would be j
~
unreasonable and would run counter to recent guidance to regulatory agencies that was issued by the Office of Management and Budget.
Therefore the Commission has, in the proposed revision, generally adhered to the following policy.
- 1. For recurring records that are created on a daily basis, for example end-of-day surveys, the Commission has made a judgment that 02/08/84 18 Enclosure 1
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records retention for one year provides adequate evidence of compliance with requirements.
- 2. For non-recurring, sporadic, or periodic records, such as individual patient dosages or survey instrument calibrations respectively, the Commission has made a judgment that records retention for two years provides adequate evidence of compliance with requirements.
- 3. In a few cases e record is only created once or the Commission considers the record to be critical evidence of compliance with regula-tions that, if not followed, might cause an immediate discernible impact on a worker or member of the public. See, for example, requirements for the geometry test for a dose calibrator and the taletherapy dosimetry squipment calibration, respectively. In those cases the commission has made a judgment that retention for the duration of the license is nd,cessary.
In a separate project the staff is beginning to develop a compre-hensive records retention policy that may conflict with the policy reflected in this proposed rulemaking. Readers should note that, for sake of uniformity, some records retention requirements may be changed when the comprehensive policy is implemented.
Effect on Broad Licensees In addition to the more common " group" licenses the NRC issues that authorize byproduct material for uses described in the groups, the NRC has also issued about 100 " broad" ifcenses under Part 33 that include human use. There are two types, a pure broad license and a hybrid broad license.
02/08/84 19 Enclosure 1
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About 50 pure human use broad licenses have been issued. They are issued to large academic institutions that have had several years experi-ence using radioactive materials, and vest in each institution's Radiation Safety Committee (RSC) the authority to permit medical practitioners to use byproduct material for human use in both patient care and medical research, and individuals 'to use byproduct material for research in test tubes and animals, and to review the facilities and safety procedures all these individuals will use. Before NRC issues a pure broad ifcense it reviews the applicant's administrative and safety procedures, the '
training and experience of the RSO and each individual member of the RSC, and the standards and procedures the RSC will.use when it reviews permit requests. This type of license is needed to allos for the orderly evolution of the medical sciences. The NRC will continue to review RSO and RSC committee member qualifications on a case-by-case basis because the size and individuality of each broad license program precludes the preparation of generic prescriptive qualifications. These licensees would be required to comply with the proposed prescriptive and perfor-mance criteria of Part 35, but wculd be exempted from the training and
, experience requirements of Subpart J and the materials and use restric-tions of proposed $$ 35.49, 35.100, 35.200, 35.300,35.400, and 35.500.
About 50 human use hybrid broad licenses have also betn issued.
They are sfailar to the pure broad license described above, except that the RSC only has the authority to permit individuals to use material in test tube and animal research, and only authorizes human use in accor-dance wit,h the groups in current S 35.100. The NRC continues to review the training and experience of medical practitioners before allowing them to use material for human use. Since the control of human use in 02/08/84 20 Enclosure 1
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thesa cases is the same as that exercised over the more common group licensees, the basis for a determination of compliance will be the same as that described below for group licensees.
Since, whether at a group or broad license facility, teletherapy is separately licensed "for treatment of humans" and the NRC reviews qualifications of proposed users and safety procedures, no significant inconsistencies with current taletherapy programs or new teletherapy programs are expected.
l Transition Policy Under the current regulatory program, the license document with the appended application is used to regulate each individual licensee. Since the requirements in the proposed revision were taken from commonly used license conditions and regulatory guidance that most licensees have incorporated in their applications, the Commission does not expect any significant inconsistencies between current licensee radiation safety programs and radiation safety programs of applicants who apply after the
, effective date of the proposed regulations. Therefore, current licensees will be cited if they do not comply with the new regulations. However, if there is inconsistency between a license and the regulation (for example a license may require survey instrument calibration biennially, but the proposed regulation would require calibration annually) with the license less stringent than the regulation, the license would be con-sidered as an exemption from the regulation. Since the less stringent license requirement was reviewed for safety considerations and approved by the NRC, such inconsistencies would not result in an increased risk to workers or the public. On the other hand, if the license requirement 02/08/84 21 Enclosure 1
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[7590-01]
is more stringent than the regulation, the ifcense requirement will stand in place of the regulation because it may serve to balance another license requirement elsewhere that is less stringent than the proposed regulation.
In the case of records retention, the regulation will take prece-dance because in the past the Commission has not offered such guidance on this topic and many applicants have either not specified a period of retention or have incorporated a single, all encompassing record reten- '
tion phrase "until the Commission authorizes their disposal" rather than shouldering the burden of justifying a shorter period. If a record has been created and it is substantively identical to a record described in the proposed regulation and no clear and specific retention requirement has been stated for that record, ifcensees could follow the retention guidance in the final rulemaking.' Licensees would still have to comply - '
with any record retention requirement for a particuale topic that is specifically stated or referenced in a license condition or another Part
- (for example Part 20) of the regulations. For example, surveys that provide the basis for occupational dose records or measurements of effluent release are governed by Part 20.
The NRC particularly requests public comments on this transition
- policy and would like to know if licensees envision problems of inter-
, pretation or compliance that the staff might not foresee.-
r DISCUSSION OF PROPOSED REGULATIONS
- The primary purpose in initiating this revision to the regulations is to simplify the regulatory process by providing licensees with a single source of requirements for the human use of byproduct material.
l l 02/08/84 22 Enclosure 1
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Radiation protection standards now contained in several existing regulations, Inspection and Enforcement orders that modify a single license or group of licenses, technical reports (NUREGs), standard conditions of licenses, and regulatory guides would be consolidated into
, a concise set of regulations. The requirements that apply to all licen-sees appear first, followed by the specific requirements for each of the six basic types of use.
The general license in current 535.31 has been eliminated from the .
proposed regulations, and all human use will be specifically licensed.
Current human use general licensees will be incorporated in NRC's filing system for keeping track of specific licensees, but they will be limited to the methods of use described in the current $ 35.31, and relieved, by license condition, from those provisions of the proposed Part 35 that are more burdensome than the current requirements for human use general licensees.
, , The only action they will need take is to respond affirmatively to a notice that asks if they want to continue to have an NRC license limited i
to the methods of use authorized by the current general license. They
- will not be assessed application, amendment, or renewal fees as long as their material use is limited to that described in current $35.31. The current Part 35 also grants a general license for in vitro work described
! in 531.11 to group licensees without requiring that they submit an in vitro registration form. Under the proposed regulation, applicants would i
have to specifically request this authorization. Part 31 will be amended to continue this authorization for current in vitro licensees.
l In the proposed regulation, items of general information, general administrative requirements, and general technical requirements are addressed first in Subparts A through C, respectively. Subparts 0 02/08/84 23 Enclosure 1
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[7590-01]
through I contain the additional technical requirements that apply to licensees for each of the six types of human use. Subpart J lists the training and experience requirements, and Subpart X lists the penalties for violations of the regulations.
In order to maintain consistency among the various parts of NRC's regulations, conforming amendments have been made to the affected sec-tions of Parts 30, 31, 32, and 40. These conforming amendments can be found immediately after the revised Part 35. A section-by-section discussion of the proposed revision of Part 35 follows.
Authority This listing provides notice that the NRC may initiate criminal prosecution of persons who do not comply with the prescriptive require-ments issued under sec. 161b or the recordkeeping and reporting require-ments . issued under sec.161o.
Subpart A--General Information 5 35.1 Purpose and scope.
The regulations in this part apply to all persons ifcensed by the Commission to intentionally administer byproduct material or the radiation from byproduct material to humans, and to individuals working under their supervision.
5 35.2 License required.
This section requires that persons have a Ifcense issued by the -
Commission or an Agreement State before they handle byproduct material for human use. The Commission uses the specific licensing process to 02/08/84 24 Enclosure 1
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[7590-01]
limit the use of byproduct material to persons who have the equipment, facilities, training, and experience needed to ensure its safe use.
Individuals who are working under the supervision of an authorized user do not need a license, but this does not relieve them of the requirement to conduct their work in accordance with requirements of the license and the regulations of this chapter. The licensee remains responsible for the noncompliance of such agents or employees, and may be subject to sanctions for their failure to comply.
$ 35.8 Reporting, recordkeeping, and appifcation requirements: OMB Approval.
This section certifies that the Office of Management and Budget has reviewed and approved the information collection requirements contained in this part.
$ 35.15 Definitions.
The term " Agreement State" was included to identify those states that have agreed with NRC to assure the safe use of byproduct material within their borders.
The word "ALARA" was added to identify the acronym for the phrase "as low as reasonably achievable."
The term " authorized user" was added to identify individuals who are identified by name on a license and who are authorized by the Commission or an Agreement State to administer byproduct material, or j the radiation therefrom, to humans for medical care, and supervise its i
use by others.
i l
l
, 02/08/84 25 Enclosure 1
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The term " dentist" was added to identify a group of practitioners licensed by the States who might use byproduct materials in their practice.
The term " human use" was included to help identify the scope of this part. The word " intentional" was added to the current definition of the term " human use" to make it clear that occupational and non-occupational exposures under the regulations of Part 20, accidental exposures, and unwanted exposures from other sources of radiation (e.g.,
nuclear powered cardiac pacemakers, smoke detectors, and radioactive waste) are not considered human use.
The word " institution" was added to identify organizations with medical byproduct material programs in which the safe use of byproduct material depends on the cooperation of individuals from several different
. departments.
The word " management" was added to identify the individual respon-sible for defining the licensee's policies and allocating personnel, budget, and space resources.
The word " misadministration" was included to define those instances in which a mistake has been made in the human use of byproduct material.
The definitions are consistent with the current 5 35.41.
The term " mobile nuclear medicine service" was added to describe the transport of byproduct material for the purpose of offering diagnos-l tic nuclear medicine services at addresses other than the principal business address of the licensee.
The word " output" was added to describe the amount of radiation in a teletherapy beam.
02/08/84 26 Enclosure 1
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i The word " physician" was included to identify individuals licensed by the States to practice medicine and therefore eligible to apply for a license to use byproduct material in the practice of medicine.
The word " podiatrist" was added to identify a group of practi-tioners licensed by the States who might use byproduct materials in their practice.
The term " qualified teletherapy calibration expert" was included to replace the term " qualified expert" which is used in the current I 35.24.
The new term t.etter reflects the training, experience, and responsibil-ities of the individual who is responsible for calibrating a licensee's taletherapy unit.
The term " Radiation Safety Officer" was added to identify the individual named on a license and who is responsible for managing the
! licensee's radiation safety program.
t The term " sealed source" was included to identify byproduct material that is specially encapsulated to prevent leakage or escape during use j and storage. It is the same definition as used in 5 30.4.
The term " provisional authorized user" was added to identify authorized l
users who, while working for a licensee on a temporary or occasional basis, use byproduct material under the restrictions of the temporary employer's license, which does not identify the visitor as an authorized user. This provisional authorization was taken from a frequently used license condition.
$ 35.16 Application for license.
At an institution, only management may apply for a license, and the individual physicians would be listed as authorized users. An individual physician may not apply for a use within an institution (an organization 02/08/84 27 Enclosure 1 l
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I that provides various medical services). This requirement reflects the ;
i need for coordination with other employ,ees who may not be under the administrative control of the authorized user. For use based outside an institution, such as for private practice or mobile service, any person may apply. An application must be filed on Form NRC-313 because it elicits information in an orderly manner that will allow for uniformity in application review procedures.
Teletherapy applications must be submitted separately because the scope and nature of information needed is much different than that needed for the other types of human use. This requirement does g imply that the applicant should have two separate safety programs.
This section also reflects the Commission's decision to delegate to Regional Administrators some licensing functions which, until recently, were conducted in the headquarters. This program was described in a Federal Recister notice published April 14, 1983 (48 FR 16030).
i 1
i
$ 35.17 License amendments.
The Commission requires that the licensee obtain an amendment for any changes in the byproduct material program that might increase the l
l potential for radiation exposure to workers and the general public, or l make it difficult for the Commission to determine whether a licensee is in compliance with its regulations. The Commission has determined that certain changes are potentially significant for the following reasons
( and thus will require an amendment:
i (1) The NRC sust be assured that the licensee has adequate training ar.d experience and facilities before authorizing a change in the type or method of human use or amount of byproduct material used. Such a change l might also indicate a need for increased inspection frequency.
! 02/08/84 28 Enclosure 1 I
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i (2) The use of byproduct material at an address not identified on I the license would make it impossible for the Commission to make unannoun-ced inspections. For the purpose of this part, the phrase " location of use" refers to a building. Except for teletherapy, moving from one room i
to another within a building would not constitute a change in location of use.
(3) The Commission must be assured that the training and exper-
- ience of Radiation Safety Officers, authorized users, and qualified teletherapy calibration experts is sufficient to ensure that they are i
able to understand and follow regulations for the safe use of byproduct material.
$ 35.18 Notifications.
A notification requirement was added to require the licensee to notify the Commission if an authorized user, Radiation Safety Officer (RS0), or qualified teletherapy calibration expert is no longer affil-l iated with the licensee's byproduct inatorial program, because the NRC would no longer be assured that the collective training and experience of the licensee's remaining personnel is adequate to assure the safe use of byproduct material for all the types of use authorized by the license.
j The Commission has made a judgment that notification within 30 days is l sufficient because technicians who have worked under the supervision of I
the authorized user can adequately assure the safe receipt and proper storage of byproduct material for a few weeks. (This parallels the l Commission's judgment that ccmmon carriers who handle byproduct material i
l 02/08/84 29 Enclosure 1
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1 packages need not be licensed). However, over a longer period of time, absence of an individual, to oversee a byproduct material program may increase the probability of an accumulation of unused byproduct material 4
or unauthorized use of material. This presents an unacceptable potential hazard.
$ 35.28 License issuance.
The Commission has selected a license term of five years. A shorter term would not benefit the public health and safety because past exper-fence indicates that medical programs do not generally change signifi-cantly over that period of time. A shorter term may unduly interfere in patient care because the licensee would spend an inordinate amount of time requesting renewals. A longer term may lead to unintentional abandonment of the license.
4 The applicant must use Form NRC-313 to provide for an orderly safety review of the appifcant's program. The Commission will apply l
l certain standards when reviewing an application so as to ensure that the safety of workers and the public will not be compromised if the license is granted. The staff must be assured that the appitcant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property ($ 30.33(a)(2)), and that the authorized users are qualified by training and experience to use the material for the purposes listed in the application in such a manner as to protect health and minimize danger to life or property ($ 30.33(a)(3)), and that the applicant has established procedures adequate to assure the safe use of byproduct material. It is the sense of Congress that fees may be 02/08/84 30 Enclosure 1 l
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necessary to recover operating costs. The Commission's discussion of this topic is in 36 FR 145, published January 6, 1971.
$ 35.29 Specific exemptions.
A person may request an exemption from any requirement of this part.
The Commission may allow the exemption if the applicant can show that it will not compromise the health and safety of workers and ther public.
Subcart 8--General Administrative Requirements
$35.30 ALARA program.
An ALARA program is a management tool needed to assure that all reasonable efforts are made to assure the safe use of byproduct material in institutions. (See ' Management Organization and Administration for ALARA' by Kathren, Health Physics, Vol. 42, No. 2, February 1982,
- p. 119-131, and ' Radiation Safety in a Nuclear Medicine Department,' by Gandsman et al., Health Physics, Vol. 38, No. 3, March 1980, p. 399-408.)
Many workers from different departments within an institution might be occasionally exposed to byproduct material. The Commission has made a judgment that a formal ALARA program is the only management tool that can provide assurance that sources of radiation and work procedures in a large facility are regularly reviewed for safety. Specific requirements usually considered part of an ALARA program are required by $5 35.31 and 35.32. Since outside of an institution the safe use of byproduct material does not usually depend on the cooperation of individuals from several different departments, and in most cases the authorized users are also 02/08/84 31 Enclosure 1
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the management, non-institutional licensees need not have a formal written ALARA program.
l 5 35.31 Radiation Safety officer.
The Radiation Safety Officer (RS0) is an individual with special expertise who is needed to coordinate the safe use of byproduct material in ac:ordance with the license and regulations.
$ 35.32 Radiation Safety Committee.
The proposed Part 35 requires institutional licensees to establish
( a Radiation Safety Committee to oversee the use of byproduct material.
Under this proposal, committee membership must include a physician
, identified on the institution's license as an authorized user of by-i product material for each type of use permitted by the license, the i institution's Radiation Safety Officer, a representative of the insti-
- tution's management and a representative of the nursing service. A similar requirement was published as a proposed rule on April 9,1979 (44 FR 21023). (Institutions that only request a Itcense for diagnostic sealed sources will be exempted from this requirement by license con-dition because the radiation safety program, due to the nature of the source and its method of use, would not depend on the cooperation of individuals from several different departments.) The NRC is not soliciting comments on the Radiation Safety Committee rule of Part 35 because an opportunity to comment on the rule has already been provided in the recently completed rulemaking on the Radiation Safety Committee.
That rulemaking, published as a final rule on September 13, 1982 (47 FR 40149), has been incorporated in the proposed wording of Part 35.
02/08/84 32 Enclosure 1
[7590-01]
To assure the safety of workers and the public in light of site-specific exigencies, the Committee must review on the basis of s (1) the qualifications of each individual to be listed as r zed an autho i user, and (2) each proposed method of use.
In its reviews, the committee should consider compliance with NRC regulations, special physical or chemical containment problems, the amount of byproduct material that will be used, and the relative hazard of the material ,
all in light of the licensee's facility and staff.
The committee must review occupational exposures.
A review more frequent than quarterly would inappropriately emphasize normal and expected statistical variations in exposure data.
A less frequent review would allow an unnecessary or unnecessarily high exposure to
- continue uncorrected for an unacceptably long period.
The quarterly review should be guided by two trigger levels for individual exposures .
The lower level would be a minimum level below which
'taken.
Above the minimum level, the source of exposure should be deter-mined and consideration given to methods of reducing the exposure r .
The higher level should trigger immediate intervention by the Radiati Safety Officer to reduce the exposure.
The committee should review the appropriateness and completeness of the intervention, and should dev a permanent solution to maintain exposures at a lower level.
i
! The annual review of the safety program is needed to determine its adequacy in light of the current and projected use of all byproduct material.
In the Commission's judgment, a review at least once each year is adequate to assure that exposures remain ALARA considering the few
{ program adjustments typically made during any single year. More time' 1
1 02/08/84 33 Enclosure 1 l
-,.e s
[7590-01]
! between reviews might not permit the committee e y recom-to make tim l mandations for avoiding unnecessary worker or patient exposure .
I 35.33 Requirement for Authority and Statement of Responsibilitie s.
To ensure that material is used safely, the RSO need and Committ a clear statement of their duties from management so that que about authority, responsibility, and jurisdiction do not keep thes individuals from acting.
$ 35.34 Provisional authorized user.
The uninterrupted provision of medical care occasionally sa req i
i visiting authorized user to work for a licensee when a its perma 1 may be unable to do so.
, This was allowed in the past by a standard license condition.
t If the licensee had a copy of an NRC license that listed the visitor as a authorized u,ser, the visitorn er could work u d the license for sixty days each year without requesting cense amend-a li ment.
The scope of this concept has been expanded to allow NRC lic to employ Agreement State authorized users, andetosixty removeday th
, time Ifmit.
In order to reduce paperwork burden, the licensee does not i
have to add the visitor as an authorized user is filed for some other purpose.
equest until an am Since the provisional authorized user's training and experience has been reviewed by a regulatory ,
public health and safety will not be adversely affected.
8 35.35 Mobile nuclear medicine service administrative requirements .
i Mobile nuclear medicine service has been limited to diagnostic human use because the inherent hazard of therapeutic amounts of b
+
02/08/84 34 Enclosure 1
4 (7590-01]
material makes it unsuitable for use in locations where th might not have clear and direct control over personnel,orfacilities equipment. ,
These licensees are required to have a letter of permission from the management of each cliet facility to assure that the client management is aware of and in agreement with the human use of bypro material within the facility.
l The Commission did not authorize transportation of multi-dose via or generators,because physicians are exempted in 8 71.9 from transpor i tion requirements, and these materials cannot be safely transported unless they are properly packaged.
Mobile service may be provided to both unlicensed and Itcensed clients, the former because they have no other access to services and the lattar because they may occasionally need assistance during peri of high patient load or technologist absence.
$ 35.37 i
Records and reports of misadministrations. ' ~
The proposed Part 35 retains the misadministration definitions and
{
reporting and recordkeeping requirements of the current PartA 35.
discussion of these requirements is in 45FR 31701, published May 14 ,
1980.
NRC is not soliciting comments on the misadministration require-I ments of the proposed Part 35 because they are the same as the require-ments of the current Part 35. On October 29, 1982, the Commission in SECY 87.-388 disapproved the staff's recommendation to propose withd of this requirement.
02/08/84 35 Enclosure 1 m 1 - - - - - - - - - - - - - -
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[7590-013
$ 35.28 Supervision.
The authorized user is qualified to use byproduct material in the practice of medicine. Frequently, specific tasks may be delegated 1
(under S 35.2(b)) to individuals with less training and experience.
However, it is necessary that a qualified individual instruct them, oversee their work on a frequent basis, and be available to promptly respond in unusual or emergency situations. 'When using byproduct mate-rial, supervised individuals must comply with 1,nstructions, procedures, and the regulations.
5 35.49 Suppliers.
In order to authorize only the use of materials reviewed.by the government for safety and effectiveness considerations, authorized users may use only byproduct material that has been manufactured and distributed under procedures that were reviewed for safety by the NRC, the Food and Drug Administration (FDA), or an Agreement State. In certain institutions, the FDA has vested in a Radioactive Drug Research Committee (RORC)
(pursuant to 21 CFR 361.1) the right and responsibility to review for safety research projects that involve the administration of radiopharma-cauticals to humans for medical reseathh. It is the Commission's judgment that the review criteria established by the FDA are, when followed by I the RORC, sufficient to assure the health and safety of the public and workers.
The NRC will continue its current practice of allowing, on a case-by-case basis, re-transfer of radiopharmaceuticals between Part 35 li-consees if an applicant specifically requests an exemption from this section and shows the exemption is in the public interest.
02/08/84 36 Enclosure 1 .
l
[7590-01] 1 i Suboart C--General Technical Recuirements
$ 35.50 Possession, use, calibration, and check of dose calibrators.
A dose calibrator is needed to ensure that the dosage of material given is the dosage that was prescribed. It must be tested for accuracy, the ability to exactly measure a specified quantity, and linearity, the ability to exactly measure a range of quantities. The requirements are generally consistent with the recommendations of the American National Standards Institute. (See ANSI M42.13-1978. In the interest of economy i
i and efficiency, the NRC uses voluntary national standards in its regula-tory program if they provide adequate assurance of safety.) The activity _ . . . . _
1evels of the accuracy check sources were chosen because a lower activity would invalidate the accuracy test due to expected statistical fluctua-tions, and a higher activity would present an unnecessary source of l radiation exposure to workers. The radionuclides required reflect the i fact that dose calibrators are not as accurate as might be expected for
! the photon energies commonly used for imaging (see " Joint NCDRH and 1
State Quality Assurance Surveys in Nuclear Medicine," HHS Publication FDA 83-8209). The linearity test should only be done over the range between highest individual dosage measured and 10 microcuries to insure that the dosage given is the dosage that was prescribed. It is not necessary to test for linearity for all amounts that might be measured, for example the first elution from a fresh generator or a multidose t I vial, because this would subject the worker to unnecessary radiation dose and would require using the complete amount for the test, thereby depleting the clinic inventory for the day. The geometry test assures that the shape of the syringe or vial containing the byproduct material 02/08/84 37 Enclosure 1
~d
[7590-01]'
does not affect the dosage measurement. The daily constancy check assures that the dose calibrator has worked consistently since it was last tested.
Licensees whose level or scope of use does not indicate need for a dose calibrator may request an exemption from this section. The request should be supported by a description of an alternative method that the licensee will use to measure radiopharmaceutical dosages.
i
$ 35.51 Calibration and check of survey instruments.
The 1000 mR/hr limit was chosen because that is the highest rad-fation exposure rate that is likely to be encountered in the medical environment. The calibration frequency and the other prescriptive and performance requirements in this section are generally consistent with ANSI N323-1978.
5 35.53 Measurecent of radiopharmaceutical dosages.
This section requires that the ifcensee assay the radioactivity of each radiopharmaceutical dosage before it is administered to a patient and keep a record of the assay results. This is required to ensure that the patient receives the intended dosage. The time at which the measure-ment must be made has been purposefully omitted to allow for flexibility in Itcensee's procedures.
- A similar requirement was published as a proposed rule on September 1,
- 1981 (46 FR 43840). The comment period on the proposed rule expired November 30, 1981. The NRC is incorporating the dosage measurement proposal in this revision. The proposed Part 35 dosage measurement requirement differs from the 1981 proposal in its recordkeeping require-ment. The Part 35 proposal requires the dosage measurement record to 02/08/84 38 Enclosure 1
. , 'T
[7590-01]
include the patient's name, and identification number if one has been assigned, and prescribed dosage. This information is not required by the 1981 proposal. NRC invites comment on the requirement that dosage measurement records include patient information. NRC is not soliciting comment on other portions of the dosage measurement requirements because they are substantively the same as the 1981 proposal. Comments received
! in response to the 1981 dosage measurement proposal will be addressed in I
the statament of consideration published with the final rule revising Part 35.
$ 35.58 Authorization for calibration and reference sources.
! These sources are needed to check and test radiation instruments and to mark images. They represent a small radiation hazard in relation to the amount of radioactivity used in patient care. The activity level s chosen to allow ifcensees to have a range of sources with several
- energies and half-lives available.
t
! 5 35.59 Requirements for possession of sealed sources.
The user must follow the manufacturer's instructions because they I
have been reviewed for safety considerations by the Commission or an l
Agreement State. The six-month test interval has been recommended by I
the National Council on Radiation Protection and Measurements (NCRP)1 in !
Report No. 57, " Instrumentation and Monitoring Methods for Radiation Protection." More frequent testing is inconsistent with ALARA l
1The National Council on Radiation Protection and Measurements (NCRP) is a nonprofit corporation chartered by Congress in 1964 to draft pro-
- posed recommendations on protection against radiation and radiation measurements, quantities, and units, particularly those concerned with radiation protection.
i i 02/08/84 39 Enclosure 1
M
[7590-01h
. considerations governing worker exposure because it would cause occupational exposure with a negligible probability of finding a leaking source. The test procedures described are intended to maximize the probability of detecting contamination from a leaking source. Report No. 57, Section 3.3.5.3 recommends minimum detectable limit of 0.005 micro-curies for equipment used to measure leak test samples. This level is
'also consistent with the requirements of other parts of the current regulations (see, for example, il 31.5 and 34.25), and is only slightly higher than the minimum detectable activity exhibited by instrumentation available to licensees. The Commission has made a judgment that this level provides the most conservative detection level technically achiev-able at-a reasonable cost. It is noted that this requirement would reduce the current permissible amount of detectable contamination from
> teletherapy sources ten-fold, from 0.05 microcuries to 0.005 microcuries for purpose of consistency. The Commission has made a judgment that the exempted sources do not present a contamination hazard because of the j small amount of radioactivity in the sources, the method in which they are constructed, the short half-life of the byproduct material, or the small hazard of the byproduct material. To conduct a physical inventory more frequently than quarterly is inconsistent with ALARA exposure goals. To inventory less frequently may, in case of a misplaced source, allow an unacceptable radiation exposure to go on for too long without detection. The radiation survey assures that sources are safely stored.
I
(
$ 35.60 Syringe shields.
Syringes that contain byproduct material are an external radiation hazard and should therefore be shielded at all times. In some cases the
( 02/08/84 40 Enclosure 1 i
[7590-01]
use of a shield when making an injection could interfere significantly with the injection. Since this would jeopardize patient benefit, in such cases the higher radiation ex90sure to the hands that is received by the technician who does not use a shield is warranted. For example, a shield need not be used when the risk of spoiling the injection is greater than the benefit of reduced worker exposure.
$ 35.61 Vial shields.
A vial radiation shield can significantly reduce the radiation exposure to the fingers and hands of an individual handling a vial of byproduct material.
$$ 35.62 Syringe labels, and 35.63 Vial labels.
Some misadministrations have been caused by accidentally trans-posing vials or syringes. The proper labelling of containers will help to avoid this type of mistake.
5 35.70 Surveys for contamination and ambient radiation exposure rate.
Since radiopharmaceuticals are frequently handled, it is plausible that a syringe or some radioactive waste may be mislaid. This would result in unnecessary radiation exposure to workers and the public. The exposure rate survey will bring this problem to the attention of workers.
The weekly exposure rate survey of waste storage areas will ensure that exposure rates in that area will be monitored so that special steps can be taken if greater than average use of radiopharmaceuticals results in higher than average exposure rates in the waste storage area.
02/08/84 41 Enclosure 1
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[7590-01]
The Commission knows that a wipe test made several days after spillage of a short-lived radiopharmaceutical will probably not detect any contamination. The periodic contamination survey serves as a check of workers' physical control of radiopharmaceuticals. If contamination is found, it indicates that controls or safety measures may be inadequate or are not always being used.
5 35.75 Release of patients containing radiopharmaceuticals or permanent
- implants.
4 A patient whose body contains byproduct material is a potentially hazardous source of radiation. The Commission proposes to allow release 1 faits based on residual activity in the patient or exposure rate at a specified distance from the patient at the licensee's option. The j 30 aCl burden limit is based on a recommendation of the NCRP and current licensing practice. The 6 mR/hr at one meter limit is based on the
, ' exposure rate from 30 sci of iodine-131, the most commonly used thera-peutic radiopharmaceutical. The Commission is considering allowing the option because the 30 act limit is consistent with NCRP guidance, but some individuals believe that the exposure rate is more relevant and easier to measure. The Commission believes that either limit provides an adequate measure of safety for the general public, and has made a judgment that further reductions in public exposure are not reasonably achievable considering the cost and potential for detrimental effect from an unnecessarily long hospital confinement.
02/08/84 42 Enclosure 1 L
1
-e
[7590-013 v
5 35.80 Mobile nuclear medicine service technical requirements. s_u (2 3 4 (
K6S The Commission has limited radiopharmaceutical transportation bypg these licensees to unit dosages because they h to be inherently safer under accident conditions and there does not appear to be suffi-cient need for bulk radiopharmaceuticals in mobile nuclear medicine 1
. service. The service must remove all radioactive waste generated during the use of byproduct material at a client facility because it is unlikely that the client facility has a license to receive and process radio-active waste. This licensee must constantly control byproduct material because, since there is no assurance that the licensee can control access to areas of use while working in a facility that is under another person's administrative control, client facilities should be considered as unrestricted areas.
Equipment checks are needed to assure the proper function of equipment t after transport and before byproduct material is handled. A survey is 1
neeced to assure that all byproduct material has been removed from the location of use. The mobile nuclear medicine service must carry a calibrated survey meter to monitor exposure and contamination in case of any accident that may result in a release of byproduct material.
I l
5 35.90 Storage of volatiles and gases.
Some radiopharmaceuticals present an inhalation or immersion hazard (e.g., iodine-131 and xenon-133). That hazard can be minimized by storing these in a fume hood or double airtight barrier (such as a l
l folded plastic bag within a folded plastic bag).
l l
l 02/08/84 43 Enclosure 1 y -- m ,, ~~-- ,---+-,----ow--r, ,r-
r
~e-
[7590-01]
t 535.92 Decay-in-storage.
~
i For most hospital radiopharmaceutical waste, decay to background '
levels is essentially complete over a period of days or months. The l requirements of 5 20.301, directed primarily at longer half-lived material, are not necessary for short half-lived radiopharmaceutical waste.
I Because the special handling required for long half-lived material is usually not needed for radiopharmaceutical waste, short half-lived waste would be exempted from the requirements of 5 20.301. A decay period of ten half-lives was chosen because such a time period will assure that, in most cases, byproduct material will have decayed to levels below those in 5 30.71, which are quantities that, under certain ordinary conditions, are exempt from a requirement for a specific ifcense.
Oecay-in-storage may only be used for radioactive material with a half-life of 65 days or less. This half-life cutoffTait was chosen because storage in excess of 650 days is more appropriately considered as permanent storage. Waste must be monitored to assure that long-lived wasta was not accidentally mixed with short-lived waste and that no waste has been added to the container since it was sealed. When the waste is monitored,
, neither the waste nor the survey instrument may have any radiation
' shielding because it might hide the presence of long-lived byproduct material in the wasta. The requirement to remove or obliterate radiation labels is in $20.203(f)(4) and is included here for completeness.
Generator columns must be individually monitored because they contained larger amounts of radioactivity and also may have small amounts of long-lived contaminants.
i l
l 02/08/84 44 Enclosure 1
~
, . ~?
[7590-01]
Subpart 0--Votake, dilution, and excretion (Group General /I )
$$ 35.100 Use of radiopharmaceuticals for uptake, dilution and excre-tion studies, and 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.
Drugs approved for human use by the FDA have a label or package insert that specifies the FDA-approved use, physical form, route of administration, and dosage range. NRC relies primarily on FDA's deter-mination of a radioactive drug's safety and effectiveness when it is used according tc the package insert. By restricting the physician to the FDA-approved physical form, route of administration, and dosage range, NRC assures the safety of the public while allowing the physician flexibility regarding the choice of the clinical procedure. The FDA also authorizes the Radioactive Drug Research Committee (RORC) at an institution to review and approve the use of radioactive materi&ls for human use for research purposes. The Commission believes that the guidelines used by the FDA when reviewing the credentials of the RORC members, and the guidelines that the FDA requires the RDRC to use when evaluating research proposals, are adequate to assure the safety of
[
workers and the public without unduly restricting medical research.
The radiopharmaceuticals listed in $35.100 were taken from those i listed in the current $535.31 and 35.100(a). Those listed in $35.200 were taken from current $535.100(b) and (c). Mercury-203 was not in-l cluded in the proposed revision because the Commission believes that there are other radiopharmaceuticals available that provide equivalent diagnostic information with much less radiation dose to the patient.
02/08/84 45 Enclosure 1 l
i
,.e
[7590-013 l Manufacturers are currently distributing generally licensed radio-pharmaceuticals under a license issued pursuant to 532.70. If this revision is adopted by the Commission, these manufacturers would have to j apply for a license amendment to distribute radiopharmaceuticals pursuant to 532.72.
l 535.120 Possession of survey instrument. .
j A low level survey instrument is needed to check areas of use for
! contamination. Since the total amount of radioactivity used for uptake, I
l dilution, and excretion studies is relatively small, the Connaission does not believe the licensee needs an ionization survey instrument to measure dose rates.
Suboart E--Imacino and localization (Group II/III) 5 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.
Xenon-133 as a gas or saline solution has been added to this group.
Manufacturers are currently distributing the product under a license issued pursuant to Part 30. If this revision is adopted by the Commis-sion, these manufacturers would have to apply for a license amendment to I
distribute xenon pursuant to $32.72.
Through continuing medical research, new uses may be found for i
existing approved radiopharmaceuticals. These new uses, which may require a different dosage, route of administration, or physical form, 4
may not appear on the manufacturer's label or package insert instruc-tions. It was such a situation that resulted in a petition filed by Dr. George V. Taplin (Docket No. PRM-35-1) requesting an exemption for 02/08/84 46 Enclosure 1
,. e 4
[7590-01]
Tc-99m pentatate as an aerosol for lung function studies. A proposed rule was published on April 13, 1982 (47 FR 15798). The comment period on this proposed rule expired June 14, 1982, and 35 comments were received.
, The NRC adopted the rule in final form without enange on February 4, 1983 (48 FR 5217). The NRC is incorporating this regulation into this revision of Part 35 without soliciting public comment because there are no substantive changes to the rule as adopted.
, f 35.204 Permissible molybdenon-99 concentration.
When molybdenum-99 undergoes radioactive decay, clinically useful technetium-99m is produced. Unwanted molybdenum may appear in the technetium solution. The permissible concentration of molybdenum-99 was chosen to be consistent with the permissible concentration listed in the United States Pharmacopeia (USP', ; the nationwide standard for all pharma-cauticals used in the practice of medicine. It is the judgment of the Commission that the USP standard provides an adequate level of safety and to require a different standard would be confusing and unproductive.
Since diagnostic dosages of technetium-99m are generally 30 millicuries or less, the maximum permissible level of molybdenum-99 in such a dosage would result in a patient receiving an undesired 4.5 microcuries of molybdenum-99. The molybdenum would be taken up primarily by the liver.
The dose to the liver would be about 0.2 rads as a result of the molyb-denue concentration. The Commission has made a judgment that this radiation dose is insignificant compared to the radiation dose which would be received by the patient due to the administration of the techna-ti um.
02/08/84 47 Enclosure 1
e
[7590-01]
The person who elutes the generator must measure and keep a record of the molybdenum concentration. Persons who receive prepared radio- 1 pharmaceuticals do not have to make this measurement. '
5 35.205 Control of aerosols and gases.
The Commission believes that a system that provides for the col-1ection or controlled dispersal of aerosols and gases is needed to reduce exposure to workers and the public. If control is by dispersal in the atmosphere, licensees should note 5 20.106, which limits the amount of radioactivity in the affluent stream.
t 5 35.220 Possession of survey instruments.
The licensee needs a low level survey instrument to check for contamination and an ionization type instrument to measure dose rates in areas where large amounts of radioactive material are stored.
Subcart F--Radiopharmaceuticals for theracy (Group IV/V) l 5 35.300 Use of radiopharmaceuticals for therapy.
l The radiopharmaceuticals listed in 535.300 were taken from those listed in the current 5535.100(d) and (e).
Drugs approved for human use by the FDA have a label or package insert that specifies the FDA-approved use, physical form, route of administration, and dosage range. NRC relies primarily on FDA's deter-mination of a radioactive drug's safety and effectiveness when used
{ according to the package insert, and therefore would require that the f
02/08/84 48 Enclosure 1
(7590-01]
licensee use the radiopharmaceuticals in accordance with the package insert.
$$35.310 Safety instruction, and 35.410 Safety instruction.
In the hospital setting, the use of byproduct material presents special training problems which are not addressed in Part 19 because they are unique to the medical environment. For example, visitor control in a hospital cannot be accomplished by physical barriers which might impede the delivery of emergency medical care. Also, after administra-tion, the byproduct material is contained in an ambulatory human. There-fore, the Commission has made a judgment that worker instruction in addition to that required by Part 19 is necessary. (This parallels special instruction required, for example, for radiographers and radio-grapher's assistants pursuant to S 34.31 of this chapter.)
535.315 Safety precautions Because of the special contamination hazards of radiopharmaceutical therapy patients, a private room with private sanitary facilities is needed to protect the public, who might be visiting nearby patients, from unnecessary exposure to radiation. The RSO must be notified in case of the patient's death or medical emergency in order to determine I
whether special contamination control procedures must be implemented.
535.320 Possession of survey instruments.
The licensee needs a low level survey instrument to check for con-tamination and an ionization type instrument to measure dose rates in l areas where large amounts of radioactive material are stored.
l 02/08/84 49 Enclosure 1
-- d l
[7590-01]
l l
Subpart G--Sources for brachytheracy (Group VI)
$ 35.400 Use of sources for brachytherapy.
This section identifies brachytherapy sources that may be used in human use. The list was taken from the current 5 35.100(e),'which is a l
l list of sources commonly used for patient care. Tantalum wire has been added.
5 35.404 Release of patients treated with temporary implants.
. A corponsibility of the Commission is to restrict the movement of
(
byproduct material when the public exposure would be increased. Brachy-therapy sources for temporary implants have high levels of radiation, and remain radioactive for a long period of time. Loss of control of these sources and their rele'ase to unrestricted areas may result in potentially lethal radiation exposure to members of the public. The Commission has made a judgment that temporary confinement of the brachy-therapy patient is necessary to assure public safety. Section 35.404 requires that the licenses confine the patient until all temporary brachytherapy sources have been removed. The records required by this section may be amalgamated with the records required by 5 35.406; there is no need for duplication.
5 35.406 Brachytherapy sources inventory.
Because of the particular hazard of brachytherapy sources due to their high activity and small size, the Commission believes that an inventory procedure that requires a nose count and line entry each time a source is handled will help to assure that if a source is misplaced, 02/08/84 50 Enclosure 1 I i
l - - . . _ _ . _ _
- M
[7590-01]
this will quickly become apparent to the licensee, who can then promptly begin a search for the source.
5 35.415 Safety precautions.
Because of the high exposure rates around brachytherapy patients, a ,
private room is needed to protect the public, who might be visiting nearby patients, from unnecessary exposre to radiation. The RSO must be notified in case of the patient's death or medical emergency to ensure that control of brachytherapy sources is retained.
S 35.420 Possession of survey instrument.
The licensee needs a h~igh level survey instrument to measure exposure rates in storage areas and uncontrolled areas around a patient's room, and to check to be sure all sources have been removed from the patient before release from confinement.
Subpart H--Sealed sources for diacnosis (Group VII)
$ 35.500 Use of sealed sources for diagnosis.
This is a new use group established to incorporate the recent development of medical devices which use a sealed source of byproduct material to create a beam of ionizing radiation. These devices are currently available to persons licensed to use materials listed in 5 35.100(f). Since the devices represent a lower level of hazard than the other sealed sources in that group, the Commission has determined that these devices should comprise a new group.
02/08/84 51 Enclosure 1
~4
[7590-01h 5 35.520 Availability of survey instrument.
The licensee needs a survey instrument to measure the exposure rates around-a packaged sealed source that is to be returned to the manufacturer, and to survey for contamination in case of an accident that might have compromised the integrity of the sealed source. However, since a source exchange is an infrequent and scheduled event, and since a hazardous accident would be a very rare occurrence, the Commission L
believes that it is sufficient, for safety purposes, to require the licensee to make arrangements to borrow or rent an instrument or contract with a measurement service when measurements are necessary.
l Suboart I--Teletherapy (Group VIII) 5 35.600 Use of a sealed source in a teletherapy unit.
This is a new use group established to deal with a well-established l type of use. Safety measures that apply to all licensees within this group have been used over the years and are reflected in these proposed regulations.
5 35.605 Maintenance and repair restrictions.
This section provides that only specially licensed persons may maintain, adjust, or repair teletherapy units because this type of work requires special training and equipment in order to be done safely.
5 35.606 Amendments.
l Amendments are required for items identified in paragraphs (a) through (f) because any change described in these paragraphs could l 02/08/84 52 Enclosure 1 i
,~. - - -
e - d
[7590-01]
result ir an increase in radiation levels in excess of the levels l
authorized in S 20.105. The service of a qualified teletherapy calibra- l tion expert is a critical component in assuring the safe use of a tele-therapy unit. The Commission has made a judgment that only an individual with prcper training and e.cperience can determine the operating character-istics of the licensee's teletherapy unit.
$ 35.610 Posted instructions.
Emergency instructions must be posted to remind individuals of the proper steps to be tsken in case of an emergency and to identify indivi-duals to be notified in an emergency. The Commission believes this is also an appropriate place to remind workers that it is important to ensure that only the patient is in the room before turning the unit on.
The reminder is necessary because it is possible that when two workers are stationed on one teletherapy unit one worker may inadvertently turn the unit on when the other worker is still in the treatment room, or a worker may turn the unit on to check its operation after a patient or ,
co-worker has entered the treatment room unbeknownst to the worker at the control console.
$ 35.615 Doors, interlocks, and warning systems.
NCRP Report No. 57, " Instrumentation and Monitoring Methods for Radiation Protection," on page 42, states that a survey of a new tele-therapy facility must determine that ". . .All entrances into the irrad-iation room or other high radiation areas are provided with barriers equipped with interlocks that are not dependent on the operation of a single circuit, and that will interrupt radiation production when the 02/08/84 53 Enclosure 1
'T
[7590-01]
barrier is opened." There have been incidents in irradiation facilities in which personnel were unnecessarily exposed to radiation because door interlocks or alarss were intentionally bypassed for convenience. See, for example, cases 19, 21, and 28 in NUREG/BR-0001, " Case Histories of Radiography Events," vol. 1, 1980. If the interlocks and warning systems had not been bypassed, personnel would n'ot have been irradiated. The Commission, however, has made a judgment that the dual warning system of a door interlock and a radiation monitor in the teletherapy room obviates i
the need for the dual circuit door interlock recommended in the report.
The beam condition indicator light will indicate to workers about to enter the room whether the unit is turned on or off.
- $ 35.620 Possession of survey instrument.
l The licensee needs a survey instrument on hand in order to measure exposure rates in case the radiation monitoring device or the teletherapy unit fails.
$ 35.621 Radiation monitoring device.
The radiation monitoring device is needed to indicate radiation levels in the teletherapy room in the event of the failure of the inter-locks or the warning system. There have been a number of reported incidents in which individuals have been unnecessarily exposed following the failure of the source retraction mechanism, coupled with a failure of the primary beam condition indicator system. Therefore, 9 35.621 requires licensees to install a permanent radiation monitor in each teletherapy room, to check its operation before using the teletherapy 02/08/84 54 Enclosure 1 l
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[7590-01]
unit, and to use a portable survey instrument or personal audible alarm dosimeter if the monitor is inoperable.
Identical requirements were published as a proposed rule on April 28, 1982, (47 FR 18131). These requirements were adopted in a final rule published January 18, 1983 (48 FR 2116). The NRC is incor-porating the rulemaking on teletherapy monitoring and servicing in this rulemaking on the revision of Part 35. NRC is not soliciting comment on the new teletherapy requirements of the proposed Part 35 because they are identical to the requirements of the' earlier 1982 rulemaking.
$ 35.622 viewing system.
If a patient moved during a therapy administration, this could result in a 200 rad dose to healthy tissue. Therefore, a viewing system is needed to monitor the orientation of the patient and the teletherapy unit to assure the prescribed application of radiation.
$ 35.630 Dosimetry equipment.
Dosimetry equipment is needed to assure that the dose prescribed is the dose actually given. In order to help ensure accuracy it must be calibrated. The equipment requirements are the same as the current
$$ 35.22 and 35.23. This section also contains the proposed resolution i
l of the petition filed by the American Association of Physicists in i
Medicine, Petition Docket No. PRM 35-2 (see 47 FR 4311; January 29, 1982). Currently, regulations require that primary dosimetry equipment
- be calibrated every two years. The petitioner requested this two year l
j requirement be relaxed to four years if, two years after calibration, the primary dosimetry system is compared with a system that was cali-02/08/84 55 Enclosure 1 l
-d
[7590-Oh brated within the past two years, and the results of the comparison indicate that the calibration factor used to convert an inst,rument reading to a dose ' measurement had not changed by more than two percent.
(Intercomparison meetings are occasionally scheduled by several quali-fied teletherapy calibration experts within a geographic area. Each expert takes a dosimetry system to the meeting, where each dosimetry system in turn is exposed to the same radiation dose from a teletherapy unit. The response of each dosimetry system can then be compardd to the response of the other systems. If each' system measures the same rad-iation dose in rads, this provides assurance that each system is working properly.) This suggestion has been incorporated into these proposed regulations. The petitioner also asked that the licensee be required to
- make quarterly constancy checks to assure the consistency of operation of the dosimetry system. The Commission did not incorporate this sug-gestion because the apparent exposure rate of constancy check devices as indicated by the dosimetry system may vary by as much as two percent even though the calibration factor for the dosimetery equipment has not changed. Therefore, the Commission does not believe that periodic 4 constancy checks would necessarily provide increased assurance of proper operation.
$ 35.632 Full calibration measurements.
Full calibrations are needed to ensure that the dose given is the dose that was prescribed. The required frequency of full calibrations )
remains unchanged from that of the current Part 35. The test for timer I accuracy has been clarified to include on-off error. The accuracy of localization devices which are used to position the teletherapy patient 02/08/84 56 Enclosure 1 i
s--~ , _ . _ _ _ . . _ . . . _ _ , . . - _
~
[7590-01]
i has been added to minimize the risk of unintentionally irradiating healthy tissue. The function of mechanical and electrical interlocks which are used to limit the directions in which the beam can be aimed, and thereby reduce the exposure rate in uncontrolled areas, has also been added. The licensee need no longer perform all measurements with a calibrated dosimetry system. Instead, the calibrated dosimetry system need only be used for one representative masurement, and then a relative exposure rate system can be used to complete the calibration. This would-allow for use of computer-controlled measurement systems that cannot be easily shipped for calibration.
The exposure rate from a radioactive source goes down as time
! progresses due to source radioactive decay. To assure accurate dose delivery, the regulation requires that licensees mathematically take this into account in calculating patient doses. The regulation requires that the licensee use time periods of not longer than one month when making decay calculations. This will assure that the actual dose does i
not differ from the calculated dose by more than one percent due to this I decay error.
S$ 35.633 Periodic spot-checks, and 35.642 Safety checks for teletherapy facilities.
A monthly spot-check is required by 5 35.22 of the current regu-lations to ensure that the teletherapy unit is giving the expected radiation dose. The following changes have been made. Timer accuracy has been clarified to include on-off error. The accuracy of localiza-tion devices has been added. The qualified teletherapy calibration expert must review the results of the spot-check measurements within 02/08/84 57 Enclosure 1
i
~(
[7590,013 fifteen days, and must notify the licensee in writing of the results of the monthly check, to assure the licensee and the Commission that the check results were reviewed by a qualified individual. The Commission has made a judgment that a response period of less than fifteen days would be unreasonably expensive. A requirement to check certain safety systems in the teletherapy facility has been added. These checks, which i
I are needed to assure that safety systems required by other sections of the regulations are working properly, need not be performed by the qual-ified teletherapy calibration expert. Devices that are not working must be promptly repaired in order to assure the safety of the teletherapy facility, e/
5 35.641 Radiation surveys for teleth,arapy facilities.
The Commission has used these maximum and average permissible source leakage radiation levels for several years as license conditioris.
They are consistent with guidance from the NCRP in its Report No. 33,
" Medical X-ray and Gamma-ray Protection for Energies up to 10 MeV -Equip-ment Design and Use," Section 4.2.2. The Commission has made a judgment that they are sufficiently restrictive to keep exposures as low as reasonably achievable.
l j 5 35.643 Modification of teletherapy unit or room before beginning treatment program.
The section is needed to require that licensees take prompt action to reduce exposure rates in uncontrolled areas that may be caused by errors in design or construction.
02/08/84 58 Enclosure 1
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(7590-013 i
$ 35.644 Reports of teletherapy surveys, checks, tests, and measurements.
Given the potential for high exposure to workers and the public, the radiation survey information required by $ 35.644 is needed to assure that teletherapy sources have been properly installed and are sufficiently shielded to assure compliance with the exposure limits of Part 20.
S 35.645 Five year inspection. ~
Many licensees replace teletherapy sources at five year intervals.
Requiring a mechanical check at five year intervals helps to assure the source exposure mechanism is in good working order and will not stick in the exposed position. The mechanic who exchanges sources and inspects 4
units can remove the source, inspect the drawer mechanism, and then install the new source. More frequent checks would require greater time near a very radioactive source. Less frequent checks would not be sufficient to assure the continuous proper operation of the exposure mechanism. The identification information in the record is needed to establish which unit was inspected, when, and by whom. The remaining information is needed so the Commission may determine that the inspec-tion was of sufficient depth to assure the health and safety of workers and the public.
Subcart J--Trainina and Experience Requirements A combination of theoreticai and practical training and experience is necessary to assure the safe use of byproduct material. The criteria in this subpart were developed by the staff with the advice of the Advisory Committee on the Medical Use of Isotopes (ACMUI). The 02/08/84 59 Enclosure 1
, --.v--.+- - , . . -
M
[7590-01]
requirements for the Radiation Safety Officer have not been published before. The requirements for authorized users are similar to those published as an amendment to Appendix A of Regulatory Guide 10.8, " Guide for the Preparation of Applications for Medical Programs," in the Federal Register on Decester 2, 1982 (47 FR 54376). The requirements for the qualified teletherapy calibration expert are similar to those required of a qualified expert pursuant to the current S 35.24.
$$ 35.900(a), 35.910(a), 35.920(a), 35.930(a), 35.940(a), 35.941(a),
35.950(a), 35.960(a), and 35.961(a) concerning certification.
The Commission has made a judgment that in some cases, certifica-tion by an appropriate professional board constitutes proof of adequate training and experience because the criteria which must be met to attain certification are more stringent than the training and experience required by the Commission. '
S 35.900(b) Authorized user as a Radiation Safety Officer.
The training and experience required by the Commission includes safety considerations for the byproduct material that the authorized user may use. Therefore an authorized user is qualified to oversee the safe use of byproduct material that he is authorized to use pursuant to the conditions of the license.
4 5 35.900(c) Training within the last five years or continuous involvement.
Radiation safety regulations and practices may be expected to change with time. The Commission has made a judgment that training 02/08/84 60 Enclosure 1
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[7590-01]
received within the preceding five years is sufficiently up-to-date to assure the safe use of byproduct material. If an individal received training more than five years prior to the application and has not had continuing involvement in the field, training must be repeatsd.
55 35.900(d), 35.910(b), 35.920(b), 35.930(b), 35.940(b), 35.941(b),
35.950(b), 35.960(b), and 35.961(b) Training and experience.
The criteria identified in these sections were developed by the staff with the assistance of the ACMUI over the past several years. The Commission has made a judgment that, for each type of use, the training and experience described is necessary to assure the safe use of byproduct material. The duration of training and experience is usually specified in classroom (not credit) hours. Training may be received as part of a formal program at an accredited university, at a proprietary school, e
from an equipment or pharmaceutical manufacturer, as private tutored .
instruction, or elsewhere. Supervized work experience must be recieved at an institution under an appropriate preceptor because usually only such an individual is qualified to teach the field use of byproduct material, and, if the experience were not received at an institution, the student would be less likely to receive experience with all the methods of use commonly used or all the management problems associated with the safe handling of byproduct material.
55 35.910(c) and 35.920(c) Integrated programs.
The Accreditation Council for Graduate Medical Education (ACGME) reviews and approves training programs for physicians. Approval of these training programs is based, in part, on adequate radiation safety 02/08/84 61 Enclosure 1
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[7590-01]
content. The Commission has made a judgment that individuals who have successfully completed an approved training program have received suffi-cient training and experience to use byproduct matcrial safely.
$$ 35.901 and 35.970 Current radiation safety officers and authorized users.
The staff has reviewed and found acceptable the training and experience of each individual who is currently listed as a radiation .
safety officer or an authorized user. Further review of the credentials of these individuals is unnecessary.
5 35.971 Three month training program. l In addition to the ACGME, the American Board of Radiology, the American Board of Osteopathic Radiology, and the American Board of Nuclear Medicine review and approve nuclear medicine training programs for physicians. These three boards independently arrived at the conclu-sion that, while currently acceptable, a three month training program may not allow sufficient time in the future to provide the training and experience needed to develop a satisfactory level of expertise in nuclear medicine, including radiation safety. All three boards and the ACGME are therefore planning to require that, by August 31, 1987, training programs be of six months duration. The Commission has made a judgment that, in the meantime, individuals who have successfully completed an approved three month training program have received sufficient training and experience to use byproduct material safely.
02/08/84 62 Enclosure 1
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[7590-01]
$ 35.990 Violations.
This section gives notice that the Commission will initiate legal proceedings if necessary to enforce requirements.
$ 31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing.
This conforming amendment grandfathers human use licensees who are also using byproduct material for in vitro work under the provisions of
$$ 31.11 and 35.14(c). In the future, applicants will have to specifi-cally request permission to use $ 31.11 materials as a separate line item on their applications so that the Commission will known how many persons are doing in vitro testing. The use of materials listed in
$ 31.11 will only be subject to the requirements of that section; Consistent with current regulatory practice, the use of materials listed in 5 31.11 will not be' subject to the requirements of Parts 19, 20, 21, and 35 except for the Mock Iodine-125 disposal, loss or theft, and notification clause of 5 31.11(f).
DERIVATION TABLE l
The following derivation table indentifies the origin of each section of the proposed regulations. Sources of the proposed regula-tions include 10 CFR Parts 19, 30, and 35, Federal Register Notices (FR), frequently used ifcense conditions, licensing staff policy, regulatory guides (RG), Office of Inspection and Enforcement bulletins, I the United States Pharmacopeia, and new text prepared by staff.
l 02/08/84 63 Enclosure 1
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[7590-01]
NEW SECTION NUMBER ORIGIN Subpart A--General Information 35.1 Purpose and scope. 35.1 revised 35.2 License required. 35.2 revised 35.8 Reporting, recordkeeping, and new text application requirements: -
OMB Approval.
35.15 Definitions.
Agreement State 20.3 ALARA acronym Authorized users term used on licenses Dentist new ters .
! Human use 35.3(a) revised Institution new tem Management new tem -
Misadministration 35.41 Mobile nuclear medicine service new term Output new term Physician 35.3(b) revised Podiatrist new tem Qualified teletherapy calibration expert new term Radiation Safety Officer term used on licenses Sealed source 30.4(r) verbatim 02/08/84 64 Enclosure 1 t
[7590-01]
Provisional authorized user new term; similar to " visiting authorized user" license condition
- 35.16 Application for license, 35.4 revised amendment, or renewal.
35.17 License amendments. new text; compare 30.38 35.18 Notifications. 'new text 35.28 License issuance. new text, compare 30.36 35.29 Specific exemptions. new text; compara 30. H Suboart 5--General Administrative Requirements 35.30 Al. ARA program. new text; see RG 10.8 Appendix 0 revised 35.31 Radiation Safety Officer. RG 10.8 35.32 Radiation Safety Committee. 35.11(b) revised 35.33 Requirements for authority new text and statement of responsibilities.
35.34 Provisional authorized user. license condition 35.35 Mobile nuclear medicine service licensing policy administrative requirements 35.37 Records and reports of 35.42 verbatim misadministrations.
35.38 Supervision, expanded from RG 10.8 p. 3 35.49 Suppliers. 35.14 revised 02/08/84 65 Enclosure 1
-- e'
[7590-013 Subpart C--General Technical Requirements 35.53 Possession, use, calibration, RG 10.8 Appendix 02 revised, and check of dose calibrators, and new text 35.51 Calibration and check of RG 10.8 Appendix 01 revised, survey instruments, and new text 35.53 Measurement of radio- proposed rulemaking 35.15 pharmaceutical dosages. (46 FR 43840; September 1, 1981) 35.58 Authorization for calibration 35.14(d) revised and reference sources.
35.59 Requirements for possession 35.14(e)(1)(i), 35.14(f)
~
of sealed sources. revised 35.60 Syringe shields. Inspection and Enforcement letter April 16, 1979 35.61 Vial shields. Inspection and Enforcement letter April 16, 1979 35.62 Syringe labels. new text 35.63 Vial labels. new text 35.70 Surveys for contamination RG 10.8 Appendix I' revised and ambient radiation exposure rate.
35.75 Release of patients containing new text radiopharmaceuticals or permanent implants.
02/08/84 66 Enclosure 1
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[7590-01]
35.80 Mobile nuclear medicine service licensing policy technical requirements.
35.90 Storage of volatiles and gases. RG 10.8 Appendix M revised 35.92 Decay-in-storage. license condition Subpart 0--Uptake, dilution, and excretion (Group General /I) 35.100 Use of radiopharmaceuticals, 35.31 and 35.100 (I) revised for uptake, dilution, and excretion studies.
35.120 Possession of survey instrument. RG 10.8 page 5 Supart E--Imacino and localization (Grouc II/III) 35.200 Use of radiopharmaceuticals, 35.100 (II) and (III) revised generators, and reagent kits for imaging and localization studies.
35.204 Permissible molybdenum-99 US Pharmacopeia i
concentration.
35.205 Control of aerosols RG 10.8 Appendix M revised and gases.
l 35.220 Posession of survey instruments. RG 10.8 page 5 Subpart F--Radiopharmaceuticals for theracy (Group IV/V) l 35.300 Use of radiopharmaceuticals i
35.100 (IV) and (V) revised j for therapy.
35.310 Safety instruction. 19.12 revised l
35.315 Safety precautions. RG 10.8 Appendix K l 02/08/84 67 Enclosure 1
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[7590-01]
35.320 Possession of survey instruments. RG 10.8 page 5 Subpart G--Sources for brachytherapy (Group VI) t 35.400 Use of sources for 35.100 (VI) revised brachytherapy.
35.404 Release of patients treated 35.14(b)(5)(vii) revised with temporary implants.
35.406 Brachytherapy sources inventory. RG 8.18 page 8 35.410 Safety instruction. 19.12 revised 35.415 Safety precautions. RG 10.8 Appendix L i
l 35.420 Possession of survey instruments. new text Subpart H--Seeled sources for diacnosis (Group VII) l 35.500 Use of sealed sources for new text diagnosis.
I' 35.520 Availabilty of survey instrument. new text I
1 l
t Subpart I--Teletherapy (Group VIII) 35.600 Use of a sealed source in new text a teletherapy unit.
35.605 Maintenance and repair license condition restrictions.
35.606 Amendments. new text 35.610 Safety instruction. license condition
, and new text 35.615 Doors, interlocks, license condition l and warning systems.
l l
! 02/08/84 68 Enclosure 1
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, [7590-01]
35.620 Possession of survey instrument. new text 35.621 Radiation monitoring 35.25 (48 FR 2115; device. January 18, 1983) 35.622 Viewing system. license condition 35.630 Dosimetry equipment. 35.22, 35.23 revised 35.632 Full calibration 35.21 revised measurements.
35.633 Periodic spot-checks. 35.22 revised and license condition 35.641 Radiation surveys for license condition teletherapy facilities 35.642 Safety checks for license condition teletherapy facilities.
35.643 Modification of teletherapy new text unit or room before beginning a treatment program.
35.644 Reports of teletherapy surveys, license condition checks, tests and measurements.
3 35.645 Five year inspection. license condition Subpart J--Training and experience requirements 4
35.900 Radiation Safety Officer. new text 35.901 Radiation Safety Officer new text training exception.
35.910 Training for uptake, Revision of Federal Register dilution, and excretion Notice (47 FR 53476; December 2, studies. 1982) 02/08/84 69 Enclosure 1 4
, ,_m . . - .
~?
[7590-01]
35.420 Training for imaging . Revision of Federal Register and localization studies. Notice (47'FR 53476; December 2, 1982) 35.930 Training for therapeutic use Revision of Federal Register of radiopharmaceuticals. Notice (47 FR 53476; December 2, 1982) 35.940 Training for therapeutic Revision of Federal Register use of brachytherapy sources. Notice (47 FR 53476; December 2, 1982) 35.941 Training for ophthalmic Revision of Federal Register use of strontium-90. Notice (47 FR 53476; December 2, 1982) 35.950 Training for use of sealed new text sources for diagnosis.
35.960 Training for teletherapy. Revision of Federal Register Notice (47 FR 53476 December 2, 1982) 35.961 Training for qualified 35.24 revised teletherapy calibration expert.
35.970 Experienced physician training new text exception.
35.971 New physician training new text exception.
6 02/08/84 70 Enclosure 1
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[7590-01]
Suboart E--Enforcement 35.990 Violations. . new text
- ADMINISTRATIVE STATEMENTS ,oo$3-Environmental Impact - Necative Declaration We The proposed rule, if adopted, would not result in any activity that significantly affects the quality of the human environment. The Commis-sion has determined that under the National Environmental Policy Act, and the criteria in 10 CFR Part 51, an environmental impact statement is not required for this proposed rule.
The environmental impact appraisal forming the basis for this deter-mination is available for inspection at the NRC Public Document Room, 1717 H Street NW., Washington, DC, and as noted in the " Addresses" section. -
Pape mark Reduction Act Statement 9 W c53 41i
.The Nuclear Regulatory Commission will submit this proposed rule to b the Office of Management and Budget (OMB) for any review that may be Ptees -ary under the Papemork Reduction Act, Public L.96-511. The SF-83
% .m st for Clearance," the Supporting Statement, and any other docu-mentation submitted to OMB, have been placed in the NRC Public Document Room at 1717 H Street NW., Washington, DC 20555, for inspection, and copying for a fee.
02/08/84 71 Enclosure 1
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[7590-01]
Regulatory Flexibility Certification Based on the information available at this stage of the rulemaking proceeding, in accordance with Section 605(b) of the Regulatory Flexi-bility Act of 1980, the Commission certifies that this proposed rule, if promulgated, will not have a s'ignificant adverse economic impact on a substantial number of small entities. The NRC has issued approximately 2600 medical licenses under 10 CFR Part 35. Of these, approximately 2200 are held by institutions, and approximately 400 by individual physicians. Most of the institutional licensees are community hospitals that range in size from 75 bed facilities to 750 bed facilities. The Small Business Administration size standards, 13 CFR Part 121, classify a hospital as a small entity if its capacity is less than 150 beds or if its gross annual receipts do not exceed $1.5 million. Under these size standards, a substantial number of NRC medical licensees could be con-sidered "small entities" for purposes of the Regulatory Flexibility Act.
Although the number of medical licensees that would fall into the.
small entity category constitutes a substantial number for purposes of the Regulatory Flexibility Act, there should not be a negative economic impact on these small entities. The primary objective of the proposed rule is to simplify the medical licensing process by consolidating requirements without lessening the protection necessary to preserve public health and safety. This will be accomplished through incorpora-i tion of frequently used license conditions into the regulations and the jp elimination or modification of requirements that are not essential to
{ g the protection of public health and safety. These steps will make it
- easier for a licenses to determine what is required to obtain a license and what is required of licensees.
l 02/08/84 72 Enclosure 1 ;
[7590-01]
The Commission has prepared a preliminary value/ impact statement for this propcsed regulation which contains information concerning the anticipated economic effect of this regulation on licensees and presents the basis for the Commission's belief that the proposed regulation would not result in additional cost to any licensees. It is available for public inspection in the NRC Public Document Room at 1717 H Street NW..
Washington, DC. Single copies are available from Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC Telephone: (301)427-4052.
Because of the widely differing conditions under which licensees covered by this proposed regulation operate, the Commission specifically seeks public comment from small entities. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the Commission of this in a comment that indicates: .
(1) The licensee's size in terms of annual income or revenue, number of employees and, if the licensee is a treatment center, the number of beds and patients treated annually; (2) How the proposed regulation would result in a significant
( economic burden on the licensee as compared to that on a larger licensee; (3) How the proposed regulations could be modified to take into account the licensee's differing needs or capabilities; (4) The benefits that would be gained or the detriments that would be avoided to the licensee, if the proposed regulations were modified as l suggested by the commenter; and (5) How the regulation, as modified, would still adequately protect l public health and safety.
F 02/08/84 73 Enclosure 1
(7590-01]
List of Suojects in 10 CFR Parts 30, 31, 32. 35, 40, and 71 Rules of General Acolicability to Domestic Licensina of Byproduct Material Part 30 - Byproduct material, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Penalty, Radiation protection, aA.
Reporting 3 requirements.
J A
GeneralDomesticLicensesforByoroductMaterial Part 31 - Byproduct material, Labeling, Nuclear materials, Packaging and containers, Penalty, Radiation protection, Reporting requirements, Scientific equipment.
- Specific Domestic License to Manufacture or Transfer Certain Items l
j Containing Byproduct Materials
^
Part 32 - Byproduct material #, Labelin Nuclear materials, Penalty, "A:
o Radiation protection, Reportinggrequirements.
Human Use Of Byproduct Material
[h M " , .
+ tJ ti RCG/BR -do s 3 -
Part 35 - Byproduct material, Drugs, Healtgdevices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
Domestic Licensina of Source Material Part 40 - Government contracts, Hazardous materials - transportation,
& &W Nuclear materials, Penalty, Reporting requirements, Sow ce material, Uranium.
1 0;u08/84 74 Enclosure 1
[7590-01]
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy R* organization Act of 1974, as amended, and section 553 of title 5 of the United States Code, notice is hereby given that adoption of the following revision of 10 CFR Part 35 and the following amendments to 10 CFR Parts 30, 32, and 40 is contemplated.
- 1. 10 CFR Part 35 is revised to read as follows:
PART 35--HUMAN USE OF BYPRODUCT MATERIAL Sec.
Subpart A--General Information 35.1 Purpose and sco'pe.
35.2 License required.
35.8 Reporting, recordkeeping, and application requirements:
OMB approval.
35.15 Definitions.
35.16 Application for license, amendment, or renewal.
35.17 License amendments.
35.18 Notifications.
35.28 License issuance.
35.29 Specific exemptions.
Subpart B--General Administrative Requirements 35.30 ALARA program.
35.31 Radiation Safety Officer 35.32 Radiation Safety Committee 35.33 Requirement for authority and statement of responsibilities.
02/08/84 75 Enclosure 1
[7590-01]
35.34 Visiting authorized user.
, 35.35 Mobile nuclear medicine service administrative requirements.
l l 35.37 Records and reports of misadministrations.
35.38 Supervision.
35.49 Suopliers.
Subpart C--General Technical Requirements 35.50 Possession, use, calibration, and check of dose calibrators.
35.51 Calibration and check of survey instruments.
35.53 Measurement of radiopharmaceutical dosages.
35.58 Authorization for calibration and reference sources.
35.59 Requirements for possession of sealed sources and brachytherapy sources.
35.60 Syringe shields.
35.61 Vial shields.
35.62 Syringe labels.
35.63 Vial labels.
l t
35.70 Surveys for contamination and ambient radiation exposure rate.
35.75 Release of patients containing radiopharmaceuticals or permanent implants.
35.80 Mobile nuclear eedicine service technical requirements.
35.90 Storage of volatiles and gases.
l 35.92 Decay-in-storage.
l Subpart 0--Uptake, dilution, and excretion (Group General /I) l 35.100 Use of radiopharmaceuticals for uptake, dilution, and excretion studies.
l 02/08/84 76 Enclosure 1
l
[7590-01] l 35.120 Possession of survey instrument.
Subpart E--Imaging and localization (Group II/III) 35.200 Use.of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.
35.204 Permissible molybdenum-99 concentration.
35.205 Control of aerosols and gases.
35.220 Possession of survey instruments.
Subpart F--Radiopharmaceuticals for therapy (Group IV/V) 35.300 Use of radiopharmaceuticals for therapy.
35.310 Safety instruction.
35.315 Safety precautions.
35.320 Possession of survey instruments.
Subpart G--Sources for brachytherapy (Group VI) 35.400 Use of sources for brachytherapy.
35.404 Release of patients treated with temporary implants.
35.406 Brachytherapy sources inventory.
35.410 Safety instruction.
35.415 Safety precautions.
i 35.420 Possession of survey instrument.
Subpart H--Sealed sources for diagnosis (Group VII) 35.500 Use of sealed sources for diagnosis.
35.520 Availability of survey instrument.
, 02/08/84 77 Enclosure 1
l
[7590-013 Subpart I--Teletherapy (Group VIII) 35.600 Use of a sealed source in a teletherapy unit. <
35.605 I l ,
Maintenance and repair restrictions. :
35.606 Amendeents.
l 35.610 Safety instruction. l t
( 35.615 Doors, interlocks, and warning systems. I 35.620 Possession of survey instrument. t i
- 35.621 Radiation monitoring deyice. -
35.622 Viewing system.
35.630 Dosimetry equipment.
35.632 Full calibration measurements. .
l 35.633 Periodic spot-checks.
35.641 Radiation surveys for teletherapy facilities.
35.642 Safety checks for teletherapy facilities.
35.643 Modification of teletherapy unit or room before beginning treatment program.
35.644 Reports of teletherapy surveys, checks, tests, and measurements.
35.645 Five year inspection.
l Subpart J--Training and experience requirements l 35.900 Radiation Safety Officer.
35.901 Radiation Safety Officer training exception.
35.910 Training for uptake, dilution, and excretion studies.
35.920 Training for imaging and localization studies.
35.930 Training for therapeutic use of radiopharmaceuticals.
35.940 Training for therapeutic use of brachytherapy sources.
02/08/84 78 Enclosure 1 l
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[7590-01]
l 35.941 Training for ophthalmic use of strontium-90.
35.950 Training for use of sealed sources for diagnosis.
35.960 Training for teletherapy.
35.961 Training for qualified teletherapy calibration expert.
35.970 Experienced authorized user training exception.
35.971 New physician training exception.
Subpart K--Enforcement 35.990 Violations.
Authority: Secs. 81,161,182,183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273); 55 35.2, 35.17, 35.30(a) and (c), 35.31(a) and (b), 35.32, 35.33, 35.34(a), 35.38, 35.49, 35.50(a)-(d), 35.51(a)-(d), 35.53(a) and (b),
35.59(a)-(c), (e)(1), (g) and (h), 35.60, 35.61, 35.62, 35.63, 35.70(a)-(f),
i 35.75,35.80(a)-(e),35.90,35.92(a),35.100,35,120,35.200,35.204(a) and (b), 35.205, 35.220, 35.300, 35.310(a), 35.315, 35.320, 35.400, j 35.404(a),35.406(a),35.410(a),35.500,35.520,35.600,35.605,35.606, 35.610(a) and (b), 35.615, 35.620, 35.621(a)-(d), 35.621(f) and (g),
l l 35.622, 35.630(a) and (b), 35.632(a)-(f), 35.633(a)-(f), 35.641(a) and (b), 35.642(a) and (b), 25.643(a) and (b), 35.645(a) and (b), 35.900, 35.910, 35.920, 35.930, 35.940, 35.941, 35.950, 35.960, and 35.961 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b));
and $$ 35.18, 35.30(c), 35.31(b), 35.33(b), 35.34(c), 35.35(b), 35.37(a)-(d),
l 02/08/84 79 Enclosure 1
. .y _
j l
[7590-01]
35.50(e), 35.51(e), 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),35.304,35.310(b),35.404(b),
35.405, 35.406(b) and (c), 35.410(b), 35.610(c), 35.621(e), 35.630(c),
35.632(g),35.633(j),35.641(c),35.642(c),35.643(c),35.644,and 35.645(c) are issued under sec. 1610, 68 Stat. 950 as amended
~
(42 U.S.C. 2201(o)).
I Subpart A -- General Information
{
I 35.1 Purpose and scope.
This part prescribes requirements for issuance of specific licenses authorizing the human use of byproduct material. This part also pre-
, scribes require'nents for the human use of byproduct material in order to provide for the protection of the public health and safety. The'provi-sions and requirements of this part are in addition to, and not in j substitution for, other requirements of this chapter. The requirements and provisions of Parts 19, 20, 21, 30, and 170 of this chapter apply to
- applicants and licensees subject to this part unless specifically exempted.
I 35.2 License required.
(a) No person shall manufacture,' produce, acquire, receive, possess, use, or transfer byproduct material for human use except in accordance with a specific license issued by the Commission or an Agreement State i
and as allowed in paragraph (b) of this section.
(b) An individual may receive, possess, use, or transfer byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in 5 35.38, unless i
prohibited by license condition.
02/08/84 80 Enclosure 1
I [7590-01]
h 19 FR l% 2.G 6 35.8 Reportino, recordkeepino, and application requirements: VWW-OMB accroval.
(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget for approval as required by the Paperwork Reduction Act (Pub.
L.96-511). OMB approved the information collection requirements on (1) The Ole control number is .
(2) OMB approval expires .
(b) The approved information collection requirements include the i
application, recordkeeping, and reporting requirements contained in 55 35.16, 35.17, 35.18, 35.30(c), 35.31(b), 35.32(a), 35.33(b), 35.34(c),
35.35(b),35.37(a)-(d),35.50(e),35.51(e),35.53(c),35.59(d),(e),(g),
and (i), 35.70(g), 35.80(f), 35.92(b), 35.204(c), 35.310, 35.404(b), 35.406, 35.410(b), 35.606, 35.610, 35.621(e), 35.630(c), 35;632(g), 35.633(e) and (j), 35.641(c), 35.642(c), 35.643(c), 35.644, and 35.645(c).
6 35.15 Definitions.
" Agreement State" means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended.
"ALARA" means as low as reasonably achievable.
" Authorized user" means a physician, dentist, or podiatrist who is identified as an authorized user on a Commission or Agreement State license that authorizes the human use of byproduct material.
" Dentist" means an individual licensed by a State or Territory of ,
the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice the art of dentistry on humans.
02/08/84 81 Enclosure 1 i
p -
[7590-013
" Human use" means the intentional internal or external administration of byproduct material, or the radiation therefrom, to human beings in the practice of medicine in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico in the art of medicine.
" Institution"meansanorganizationinwhichseveralmedical t
disciplines are practiced. .
" Management" means the chief executive officer.
" Misadministration" means the administration of:
(1) A radiopharmaceutical or radiation from a sealed source other than the one intended; -
(2) A radiopharmaceutical or radiation to the wrong patient; (3) A radiopharmaceutical or radiation by a route of administra-tion other than that intended by the prescribing physician; (4) A diagnostic dosage of a radiopharmaceutical differing from i
the prescribed dosage by more than 50 percent; (5) A therapeutic dosage of a radiopharmaceutical differing from the prescribed dosage by more than 10 percent; or (6) A therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10 percent.
" Mobile nuclear medicine service" means the transportation and use of byproduct material for human use and for checks and tests of equipment used in conjunction with human use by the ifcensee.
" Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.
02/08/84 82 Enclosure 1 i
L
[7590-01]~
" Physician" means a medical doctor or doctor of osteopathy licensed 4
by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.
" Podiatrist" means an indi.vidual licensed by a State or Territory i
of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice the art of podiatry on humans.
" Provisional authorized user" means an authorized user who is not identified on the license of the person for whom he is working.
" Qualified teletherapy calibration expert" means the individual identified as the qualified teletherapy calibration expert on a Commission license.
- " Radiation Safety Officer" means the individual identified as the Radiation Safety Officer on a Commission license. '
" Sealed source" means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.
6 35.16 Apolication for license. amendment, or renewal.
(a) For use in an institution, only management may apply. For use outside an institution, any person may apply.
1
- (b) An application for a license for human use of byproduct material as described in $635.100, 35,200, 35.300, 35.400, and 35.500 of this part must be made by filing Form NRC-313, " Application for Materials j License." For guidance in completing the form refer to the instructions contained in Regulatory Guide 10.8 Revision 2, " Guide for the Preparation of Applications for Medical Programs." A request for a license snendment i
or renewal may be submitted in letter format.
02/08/84 83 Enclosure 1 t
[7590-01]
4 X O (c) An application for a license for human use of byproduct material W Ig g(h #
as described in 335.600 of this part must be made by filing Form NRC-313.
b For guidance in completing the form refer to the instructions contained h in Regulatory Guide 10.X, " Guide for the Preparation of Applications for Teletherapy Programs." A request for a license amendment or renewal may l be submitted in letter format.
(d) The applicant shall mail the completed application form as directed below.
- (1) If the applicant is not a Federal agency and is located in l l
I Connecticut, Delaware, Maine, Massachusetts, New Jersey, Pennsylvania, '
or Vermont, the applicant shall mail or deliver the completed appli-cation form to U.S. Nuclear Regulatory Commission, Region I, Material Licensing, 631 Park Avenue, King of Prussia, Pennsylvania 19406.
(2) If the applicant is not a Federal agency and is located in Virginia or West Virginia, the applicant shall mail or deliver the completed application form to U.S. Nuclear Regulatory Commission, Region II, Material Licensing Section, 101 Marietta Street, Suite 3100, Atlanta, Georgia 30303.
(3) If the applicant is not a Federal agency and is located in Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, or Wis-consin, the applicant shall mail or deliver the completed application form to U.S. Nuclear Regulatory Commission, Region III, Material Licen-sing Section, 799 Roosevelt Road, Glen Ellyn, Illinois 60137.
N 6 30- (4) If the applicant is not a Federal agency and is located in kh klahoma, Montana, South Dakota, tttah, or Wyoming, the applicant shall b[ mail or deliver the completed o U. S. Nuclear Regulatory Commission, Region IV, Material 4icensing Section, 611 Ryan Plaza Drive, Suite 1000, Arlington, Texas 76011.
02/08/84 84 Enclosure 1
[7590-01]
(5) If the applicant is not a Federal agency and is located in Alaska, Hawaii, or a U.S. territory or possession in the Pacific, the applicant shall mail or deliver the completed application form to U.S.
Nuclear Regulatory Commission, Region V, Material Licensing Section, 1450 Maria Lane, Suite 210, Walnut Creek, California 94596.
(e) If the applicant is a Federal agency, if the applicant is an
- agency of the District of Columbia, or if the applicant is located in a State, territory, or possession that is not mentioned in paragraphs (d)(1) through (5), of this section, the applicant shall
(1) Mail the completed application form to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or (2) Deliver the completed application form to the Commission offices at:
(i) 1717 H Street NW., Washington, DC, or 1
(ii) 7915 Eastern Avenue, Willste Building, Silver Spring, Maryland.
1 35.17 License amendments.
A licensee shall apply for and must receive a license amendment:
(a) Before using byproduct material for a method or type of human use not permitted by the ifcense issued under this part; (b) Before the licensee permits anyone, except a provisional authorized user described in 5 35.34, to work as an authorized user under the license; (c) Before the licensee permits an individual not listed on the '
license to perform the duties of the Radiation Safety Officer or Qual-ffied Teletherapy Calibration Expert; 02/08/84 85 Enclosure 1 m.- - ,- , , - . _ .,.,y,_ , . _ , ,
~
a
[7590-01]
(d) Before receiving byproduct material in excess of the amount authorized on the license; and (e) Before adding to or changing the location or locations of use or mailing address identified on the license.
t 35.18 Notifications.
, The licensee shall notify the commission by letter within thirty days when an authorized user, Radiation Safety Officer, or qualified teletherapy calibration expert, permanently discontinues performance of duties under the license. The licensee shall mail the report to the appropriate address identified in 6 35.16.
I 35.28 License issuance. .
The Commission shall issue a license for the human use of byproduct material for a term of five years if:
(a) The applicant has filed Fors NRC-313 Application for Materials License in accordance with the instructions in $35.16; '
i
- (b) The applicant has paid any applicable fee as provided in i Part 170 of this chapter; 1 1
(c) The Commission finds the applicant equipped and committed to
)
observe the safety standards established by the Commission for the protection of the public health and safety; and (d) The applicant meets the requirements of Part 30 of this chapter.
4 i
6 35.29 Specific exemotions.
The Commission may, upon application of any interested person or
- upon its own initiative, grant such exemptions from the regulations in l
02/08/84 86 Enclosure 1 l l
l
[7590-01]
this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
4 Subpart 8--General Administrative Requirements E 35.30 ALARA procras.
(a) Each institutional licensee shall establish a program to maintain individual and collective dose equivalents as low as reasonably achievable.
(b) To satisfy the requirement of paragraph (a) of this section:
(1) Management, the Radiation Safety Officer, and all authorized
- users must participate in the establishment, implementation, and oper-ation of the program as required by the regulations or requested by the Radiation Safety Committee.
(2) The program must include an annual review by the Radiation Safety Committee of the types and amounts of byproduct material used, occupational dose reports or summaries, and continuing education and 4
training for all personnel who work with or in the vicinity of byproduct material. The purpose of the review is to ensure that individuals make every reasonable effort to maintain individual and collective occupational dose as low as reasonably achievable, taking into account the state of
- technology, and the cost of improvements in relation to benefits.
(c) The licensee shall keep a written description of the ALARA program for the duration of the license. The written description must include:
(1) A commitment by management to keep individual and collective occupational dose as low as reasonably achievable; 02/08/84 87 Enclosure 1
_-.e-.ym..,.m,,.,m,..__-..,m._--,..-- , , , _ - _ _ _ _ _ - , . , .,,m.- -,___m.--__-____- . . _ _ - - . - . _.____ _ _ _ __ _
, - , . . . . . . - - - . - - - - - - -_.a, r. - -
[7590-013 i
(2) A requirement that the Radiation Safety Officer brief management once each year on the byproduct a terial program; (3) Personnel exposi:.e investigational levels that, when exceeded,
- will initiate an investigation of the cause of the exposure by the Radiation Safety Officer; and (4) Personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation of the cause of the exposure by the Radiation Safety Officer and a consideration of actions that might be 4
taken to reduce the probability of recurrence.
l 6 35.31 Radiation Safety Officer.
l
! (a) Each licensee shall appoint a Radiation Safety Officer who is l
- responsible for implementing the radiation safety program. The Radiation
[ Safety Officer must be reponsible to the licensee's management for l ensuring that radiation safety activities are being correctly performed j in accordance with approved procedures in the daily operation of the i
licensee's byproduct material program.
(b) The Radiation Safety Officer shall:
(1) Investigate known instances of deviation from good practice and implement corrective actions as necessary; (2) Establish and implement written policy and procedures for:
(i) Authorizing the purchase of byproduct material; (ii) Receiving and opening packages of byproduct material; (iii) Storing byproduct material; (iv) Keeping an inventory record of byproduct material; (v) Using byproduct material safely; i
- 02/08/84 88 Enclosure 1 l
i
[7590-01]
(vi) Taking emergency action in the event of loss of control of byproduct material; (vii) Performing periodic radiation surveys; (viii) Performing checks of survey instruments and other safety equipment; (1x) Disposing of byproduct material safely; (x) Training personnel who work in or frequent areas where byproduct material is used or stored; (xi) Keeping.a copy of all records and reports required by the regulations, a copy of the regulations, a copy of the license application and ifcense and amendments, and the written policy and procedures required by the regulations.
(3) For use not at an institution, approve or disapprove modifications of procedures with the advice and consent of management; and (4) For use at an institution, assist the Radiation Safety Cossaittee in the performance of its duties.
6 35.32 Radiation Safety Committee.
Each institutional licenses shall establish a Radiation Safety Committee to oversee the use of byproduct material. Management may establish more than one cossaittee to meet these responsibilities, but each committe that is established shall meet the administrative require-ments. To satisfy this requirement:
l (a) The committee must meet the following administrative requirements:
, (1) Membership must consist of at least three individuals and must I
- include an authorized user for each type of use permitted by the license, l the Radiation Safety Officer, a representative of the nursing service, l
l 02/08/84 89 Enclosure 1 1
. ----- ., p. - - , - - - - - - . - - - . - - ,n--------we--n-w-..----,.,-,----------n-m.--,--+ ,+ ..--n--,-------- - - - - - - - - - - - - - - - - "
t i
(7590-013 if there is one, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be j
- included as the licensee deems appropriate.
(2) The committee must meet a least quarterly.
I (3) To establish a quorum and to conduct business, one-half of the committee's membership must be present, including the Radiation Safety i Officer and the management representative.
(4) The minutes of each Radiation Safety Committee meeting must include:
)
(i) The date of the meeting; I
\
! (ii) Members present; I 4 )
(iii) Members absent; l (iv) Summary of deliberations; (v) Recommended actions and the numerical results of all ballots;
. and I
'(vi) ALARA program reviews described in 535.30(b)(2) l 1
(5) The Committee must provide each member with a copy of the !
meeting minutes, and maintain one copy for the duration of the license. 1 (b) To oversee the use of licensed material, the committee must:
(1) Se responsible for monitoring the institutional program to l maintain individual and collective doses as low as reasonably achievable; ;
f (2) Review on the basis of safety and approve or disapprove any individual who is to be listed as an authorized user or the Radiation Safety Officer before submission of the license application or application
- for amendment; (3) Review on the basis of safety and approve or disapprove each proposed method of use of byproduct material; i
02/08/84 90 Enclosure 1 l
- , . ~ . . - - - . . ~ . . . , _ . - _ _ , _ _ - _ , , . . _ - - , _ . . . , _ , _ _ _ . _ - _ . . _ . .-,,,__,____,,,,n..._ , _ _ - - - - .
[7590-01]
4 (4) Review on the basis of safety and approve or disapprove with the advice and consent of the Radiation Safety Officer and the management representative, procedures and modifications of procedures for the safe use of byproduct material; (5) Review quarterly, with the assistance of the Radiation Safety
~
Officer, occupational radiation exposure records of all personnel working with byproduct material; (6) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with r,espect to i
cause and subsequent actions taken; (7) Review annually, with the assistance of the Radiation Safety Officer, the byproduct material program; and (8) Establish a table of investigational levels for occupational dose that, when exceeded, will initiate investigations and consider-ations of action by the Radiation Safety Officer.
- 6 35.33 Requirement for authority and statement of responsibilities.
(a) The licensee shall provide the Radiation Safety Officer, and '
at an institution the Radiation Safety Committee, sufficient authority and organizational freedom to:
(1) Identify radiation safety problems;,
- (2)- Initiate, recommend, or provide solutions; and (3) Verify implementation of solutions.
(b) The licensee shall establish in writing the authorities, i
l duties, responsibilities, and radiation safety activities of the Radiation i
Safety Officer, and at an institution the Radiation Safety Committee.
i 02/08/84 91 -
Enclosure 1 i
e _ . - - . - . - ~ . - , - . - - - . - - __mm-..-. ,,,m--,--+--- -, - - , - , , - - -- - - .w- .m----.. - , . ..--..---,.-,..---,y, -w
e
[7590-013 -
1 35.34 Provisional authorized user.
(a) A licensee may permit any provisional authorized user to use licensed material for human use under the terms of the licensee's license if:
(1) The provisional authorized user has the prior written permission of the lice'nsee's management and, if such use occurs on behalf of an institution, the institution's Radiation Safety Committee; (2) The licensee has a copy of a Commission or Agreement State l license that lists the provisional authorized user as an authorized user i for human use; and (3) The provisional authorized user performs only those procedures for which he is specifically authorized by a Commission or Agreement State license.
(b) The_licenseeneednotapplyforalicense'aiendmentinorder
- to permit a provisional authorized user to use licensed material as described in paragraph (a) of this section.
(c) The licensee must request that the provisional authorized user j be listed as an authorized user the next time the licensee applies for a license amendment or renewal.
(d) The licensee shall retain for two years after the provisional authorized us'er's last use of licensed material copies of the records specified in this section unless the provisional authorized user has been listed as an authorized user on the licensee's license.
1 35.35 Mobile nuclear medicine service administrative recuirements.
(a) The Conssission will only license mobile service in accordance with Subparts 0, E and H of this part and 5 31.11 of this chapter.
02/08/84 92 Enclosure 1 i
[7590-01]
(b) Mobile service licensees shall retain for the duration of service a letter signed by the management of each location where services are rendered that authorizes use of byproduct material.
6 35.37 Records and reports of misadministrations.
(a) When a misadministration involves any therapy procedure, the licensee shall notify by telephone the appropriate NRC Regional Office listed in Appendix 0 of Part 20 of this chapter. The licensee shall also notify the referring physician of the affected patient and the patient or a responsible relative (or guardian), elless the referring physician personally informs the licensee either that he will inform the patient or that, in his medical ~ judgment, telling the patient or the patient's responsible relative (or guardian) would be harmful to one or the other, respectively. These notifications shall be made within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee discovers the misadministration. If the referring physician, patient, or the patient's responsible relative or guardian cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify 1
them as soon as practicable. The licensee is not required to notify the patient or the patient's responsible relative or guardian without first consulting the referring physician; however, the licensee shall not l
delay medical care for the patient because of this.
(b) Within 15 days after an initial therapy misadministration report to NRC, the licensee shall report, in writing, to the NRC~ Regional Office initially telephoned and to the referring physician, and furnish a copy of the report to the patient or the patient's responsible relative (or guardian) if either was previously notified by the licensee under paragraph (a) of this section. The written report shall include the 02/08/84 93 Enclosure 1
[7590-O'1]
1 licensee's name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; whether the licensee informed the patient or the patient's responsible relative (or guardian), and if not, why not. The report must not include the patient's name or other information that could lead to identification of the patient.
(c) When a misadministration involves a diagnostic procedure, the licensee shall notify, in writing, the referring physician and the appropriate NRC Regional Office listed in Appendix 0 of Part 20 of this 4
chapter. Licensee reports of diagnostic misadministrations are due
. _ . within 10 days after the end of the calendar quarters (defined by March, June, September and December) in which they occur. These written reports must include the licensee's name; the referring physician's name; a description of the event; the effect on the patient; and the action i taken to prevent recurrence. The report should not include the patient's name or other information that could lead to identification of the patient.
(d) Each licensee shall maintain for the duration of the license a l record of each misadministration. The record must contain the names of all individuals involved in the event (including the physician, allied health personnel, the patient, and the patient's referring physician),
the patient's social security number, a brief description of the event, the effect on the patient, and the action taken to prevent recurrence.
(e) Aside from the notification requirement, r}othing in this
- section shall affect any rights or duties of licensees and physicians in l
I relation to each other, patients, or responsible relatives (or guardians).
02/08/84 94 Enclosure 1
[7590-01]
6 35.38 Supervision.
The licensee who permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an l authorized user as authorized by $ 35.2(b) shall:
. (a)(1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct
~
material; (2) Review the supervised individual's use of byproduct material and the records kept to reflect such use; (3) Require the authorized user to be immediately available by telephone to the supervised individual; and (4) Require the authorized user to be able to be physically present ,
and available to the supervised individual on one hour's notice. The supervising authorized user need not be present for each use of byproduct
~
naterial .
(b) Require the supervised individual receiving, possessing, using or transferring byproduct material under 5 35.2(b) to:
(1) Follow the instructions of the supervising authorized user; (2) Follow the procedures established by the Radiation Safety l Officer and (3) Comply with the regulations of this part and the license conditions with respect to the use of byproduct material, l
l r
l 6 35.49 Suppliers.
The licensee may use for human use only:
(a) Byproduct material manufactured, labeled, packaged, and distributed i in accordance with a license issued pursuant to the regulations in 02/08/84 95 Enclosure 1 i
r-s ,- g,,- y,,n---,,-,m--- y ,ww.- ymmaawa,w,~v--go -------+-~-~w~ =v~~-avyr~~'-4r---'tmw'--~'wv v've**~me-w-v~w m ~w-w"~"*"~'"'"'~"~'d
[7590-01]
Part 30 and $$ 32.72, 32.73, or 32.74 of this chapter or equivalent regulations of an Agreement State; (b) Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with an approval by the Commission pursuant to I 32.73 or an Agreement Stata under equivalent regulations for the preparation of radiopharmaceuticals for human use; (c) Radiopharmaceuticals authorized by a Radioactive Drug Research Committee that has been approved by the Food and Drug Administration pursuant to 21 CFR 361.1; and (d) Teletherapy sources manufactured and distributed in accordance with a license issued persuant to Part 30 of this chapter or equivalent regulations of an Agreement State.
Subpart C--General Technical Requirements i 35.50 Possession, use, calibration, and check of dose calibrators.
(a) Each human use licensee who is authorized to administer
- radiopharmaceuticals shall have in his possession a dose calibrator and use it to measure the amount of activity administered to each patient.
(b) The licensee shall:
(1) Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy the require-ment of this paragraph, the check must be done on a frequently used l setting with a sealed source of not less than 10 microcuries of radium-226 or 50 microcuries of any other photon-emitting radionuclide; i
j (2) Test each dose calibrator for accuracy upon installation and
- at least annually thereafter by assaying at least two sealed sources 02/08/84 96 Enclosure 1 i
[7590-01]
containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated activity, whose activity is at least 10 microcuries for radium-226 and 50 microcuries for any other photon-emitting radionuclide, and at' least one of which has a principal photon energy between 100 kev and 500 kev; 4
(3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the range of its use between the highest dosage that will be administered and 10 microcuries; and (4) Test each dose calibrator for geometry dependence upon installa-tion-over the range of volumes and volume configurations for which it will be used. The licenses shall keep a record of this test for the duration of the use of the' dose calibrator.
(c) The licensee shall also perform appropriate checks and tests required by this section following adjustment or repair of the dose calibrator.
(d) The licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries and shall repair or replace the dose calibrator if the accuracy error exceeds 10 percent.
t (e) The licenses shall retain a record of each check and test required by this section for two years unless directed otherwise.
(1) The record required in paragraph (b)(1) of this r. action must include the model and serial number of the dose calibrator, the identity of the radionuclide contained in the check source, the date of the check, the activity measured, and the initials of the individual who performed the check.
L i
02/08/84 97 Enclosure 1
~
[7590-01]
(2) The record required in paragraph (b)(2) of this section must include the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radio-nuclide contained in the source and its activity, the date of the test, theresultsofthetekt,andthesignatureoftheRadiationSafety.
Officer.
(3) The record required in paragraph (b)(3) of this section must include the model and serial number of the dose calibrator, the calcu-lated activities, the measured activities, the date of the test, and the signatu"e of the Radiation Safety Officer.
(4) The record required in paragraph (b)(4) of this section must include the model and serial number of the dose calibrator, the configu-ration of the source measured, the activity measured for each volume measured, the date of the test, and the signature of the Radiation i
Safety Officer.
6 35.51 Calibration and check of survey instruments.
(a) The licensee shall calibrate the survey instruments used to show compliance with this Part before first use, annually, and following l
repair; (b) To satisfy the requirements of paragraph (a) of this section, the licensee shall:
(1) Calibrate all scale readings up to 1000 milliroentgens per hour with a radiation source;
- (2) Calibrate two readings on each scale that must be calibrated; and l
I 02/08/84 98 Enclosure 1
'I
[7590-01]
(3) Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration.
(c) To satisfy the requirements of paragraph (b) of this section, the licensee may: ...
(1) Consider a point as calibrated if the indicated exposure rate differs from the esiculated exp'osure rate by not more than 10 percent; aM (2) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent if a correction chart or graph is conspicuously attached to the instrument.
(d) The licensee shall check each survey instrument for proper i operation with the dedicated check source before and after each use.
I The licensee is not required to keep records of these function checks.
I i (e) The licensee shall retain a record of each calibratton required
, in paragraph (a) of this section for two years. To satisfy the require-ments of this paragraph, the record must include:
(1) A description of the calibration procedure; and (2) A description of the source radionuclide used and its certified activity, the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the signature of the individual who performed the calibration.
I 35.53 Measurement of radiopharmaceutical dosaaes.
The licensee shall:
02/08/84 99 Enclosure 1 l
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(a) Assay before human use the activity of each radiopharmaceutical dosage that contains more than 10 microcuries of a photon-emitting radionuclide; (b) Assay before human use the activity of each radiopharmaceutical dosage with a desired activity of 10 microcuries or less of a photon-emitting radionuclide to verify that the dosage does not exceed 10 microcuries; (c) Retain a record of the measurements required by this section for two years. To satisfy this requirement, the record must contain the:
(1) Generic name, trade name, or abbreviation of the radiopharma-cautical, its lot number, and expiration date; (2) Patient's name, and identification number if one has been assigned; (3) F.escribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than 10 microcuries; ~
(4) Date and time of the measurement; and (5) Initials of the individual who made the measurement.
6 35.58 Authorization for calibration and reference sources.
Any person authorized by 5 35.2 for human use of byproduct material may receive, possess, and use the following byproduct material for check, calibration, and reference use:
(a) Sealed sources that were manufactured and distributed by a person licensed pursuant to $ 32.74 of this chapter or equivalent Agree-ment State regulations and that do not exceed 6 millicuries each; 02/08/84 100 Enclosure 1 i
[7590-01]
(b) Any byproduct material listed in gg 35.100 or 35.200 with a half-life not longer than 100 days in individual ascunts not to exceed 15 mil 11 curies; (c) Any byproduct material listed in $5 35.100 or 35.200 with a half life longer than 100 days in individual amounts not to exceed 200 microcuries each; (d) Technetium-99m in individual amounts not to exceed 50 millicuries.
I 35.59 Requirements for possession of' sealed sources and brachytheracy sources.
(a) A licensee in possession of any sealed source or brachytherapy source shall use the source in accordance with radiation safety and handling instructions supplied by the manufacturer, and shall maintain such instructions in a legible form convenient to users of the source.
1 (b) A licensee in possession of a sealed source shall:
(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier ind cating that the source was tested within six sonths prior to transfer to the licensee; and (2) Test the source for leakage at intervals not to exc2ed six n)nths or at other intervals approved by the Commission or an Agreement State and described in the label or brochure that accompanies the source.
(c) To satisfy the leak test requirements of this section, the licensee must:
(1) Take a wipe sample frora the sealed source or from the surfaces cf the device in which the sealed source is mounted or stored on which radioactive contaminttien might be axpected to accumulata or wash the source in a small volume of detergent solution and treat the entire volume as the sample; 02/08/84 101- Enclocure 1 l
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(2) Take teletherapy source test sample when the source is in the "off" position; and (3) Measure the sample so that the leakage test can detect the l
presence of 0.005 microcuries of radioactive material on the sample.
)
(d) The licensee shall retain leakage test records for two years.
The records must contain the model number and serial number if assigned l
)
of each source tested, the identity of each source radionuclide and its i l
estimated activity, the measured activity of each test sample expressed !
in microcuries, a description of the method used to measure each test '
sample, the date of the test, and the signature of the Radiation Safety
. Officer.
i (e) If the leakage test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall:
(1) Immediattely withdraw the sealed source from use and store it in accordance with Parts 20 and 30 of this chapter; and (2) File a report within five days of the leakage test with the i
appropriate Nuclear Regulatory Commission Regional Office listed in l Appendix 0 of Part 20 of this chapter, with a copy to Director of Inspection and Enforcament, U.S. Nuclear Regulatory Commission, Washington, DC l 20555, describing the equipment involved, the test results, and the 1
corrective action taken.
l (f) The licensee need not perform a leakage test on the following sources:
(1) Sources containing only byproduct material with a half-life of l
1ess than 30 days; j (2) Sources containing only byproduct material as a gas; U2/08/84 102 Enclosure 1 I
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(3) Sources containing 100 microcuries or less of beta or gamma-emitting material or 10 microcuries or less of alpha-emitting material; (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage prior to any use or transfer unless it
_has been leakage-tested within six months prior to the date of use or transfer;
~
(5) Seeds of iridium-192 encased in nylon ribbon; (6) Sources containing only hydrogen-3; (7) Wires of iridium-192; and (8) Wires of tantalum-182.
(g) Any licensee in possession of a sealed source or brachytherapy source shall conduct a quarterly physical inventory of all such sources in the licensee's possession. The licensee shall retain each inventory
, record for two years. The inventory records must contain the model i
number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, and the signature of the Radiation Safety Officer.
(h) Any licensee in possession of a~ sealed source or brachytherapy source shall survey with a low range survey meter quarterly all areas where such sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
(i) The licensee shall retain a record of each survey required in paragraph (h) of this section for two years. The record must include the date of the survey, a plan of each area that was surveyed, the
- measure'd exposure rate at several points in each area expressed in l
02/08/84 103 Enclosure 1 l
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aillires per hour, the model number and serial number of the survey instrument used to make the survey, and the signature of the Radiation Safety Officer.
6 35.60 Syrince shields. ~
(a) The licensee shall keep syringes that contain byproduct mate-rial to be administered in a radiation shield.
(b) The licensee shall require each individual who administers a radiopharmaceutical by injection to use a syringe radiation shield unless the use of the shield is contraindicated for that injection.
4 35.61 Vial shields.
The licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield. ,
6 35.62 Syrince labels.
The licensee shall conspicuously label each syringe, or syringe radiation shield that contains a syringe with a radiopharmaceutical to be administered, with the radiopharmaceutical abbreviation or type of diagnostic study or therapy procedure to be performed.
6 35.63 Vial labels.
The licensee shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical to be administered with the chemical name or its abbreviation. ,
I l
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I 35.70 Surveys for contamination and ambient radiation exposure rate.
(a) The licenses shall survey with a low range survey meter at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.
(b) The licensee shall survey with a low range survey meter at least once each week all areas where radiopharmaceuticals or radio-pharmaceutical waste is stored.
(c) The licensee shall conduct the surveys required by paragraphs (a) and (b) of this section so as to be able to measure exposure rates that are greater than 0.1 mil 11 roentgen per hour.
(d) The licensee shall establish radiation exposure rate action levels for the surveys required by paragraphs (a) and (b) of this section and shall require that the individual who is performing the survey imme-diately notify the Radiation Safety Officer if an exposure rate exceeds -
an action. level.
(e) The licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.
(f) The licensee shall conduct the surveys required by paragraph (e) i of this sectionso as to be able to detect contamination on each wipe sample of 200 disintegrations per minute.
i (g) The licensee shall establish removable contamination action levels for the surveys required by paragraph (e) of this section and i
shall require that the individual who is performing the survey immedi-ately notify the Radiation Safety Officer if contamination exceeds the action level.
l 02/08/84 105 Enclosure 1
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1 i
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(h) The licensee shall retain a record of each survey for one l 1
year. The record must include the date of the survey, a plan of each l
area that was surveyed, the action level established for each area, the measured exposure rate at several points in each area expressed in '
millires per hour or disintegrations per minute, the model number of the I instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey.
)
l 9 35.75 Release of patients containing radiopharmaceuticals or permanent isolants.
(a) The licensee shall not authorize release from confinement for medical care of any patient administered a radiopharmaceutical until either:
(1) The exposure rate from the patient is.less than 6 milliroentgens per hour at a distance of one meter; or (2) The activity in the patient is less than 30 mil 11 curies.
(b) The licensee shall not authorize release from confinement for medical care of any patient administered a permanent brachytherapy isolant until the exposure rate from the patient is less than 6 milli-roentgens per hour at a distance of one meter.
6 35.80 Mobile nuclear medicine service technical requirements.
A licensee providing mobile service shall:
(a) Transport to each location of use only syringes or vials containing unit dosages of prepared radiopharmaceuticals; (b) Bring into each location of use all byproduct material to be used and, before leaving, remove all unused byproduct material and all i associated waste; 02/08/84 106 Enclosure 1
[7590-01]
(c) Secure or keep under constant surveillance and immediate control all byproduct material when in transit or at a location of use; (d) Check survey instruments and dose calibrators as described in 55 35.50 and 35.51, and check all other transported equipment for proper function before administering byproduct material to humans at each location of use;
~
(e) Carry a calibrated survey meter in each vehicle that is being used to transport byproduct material, and survey for ambient radiation exposure rate with a low range survey meter prior to departure from the location of radiopharmaceutical use to ensure that all radiopharmaceuticals and all associated waste have been removed; and (f) Retain a record of each survey required in paragraph (e) of this section for one year. The record must include the date of the survey, a plan of each area that was surveyed, the measured exposure
, rate at several points'in each area expressed in millirem per hour, the model number of the instrument used to make the survey, and the initials of the individual who performed the survey.
6 35.90 Sterace of , volatiles and cases.
The licensee shall store volatile radiopharmaceuticals and radioactive gases in a fume hood or in a container with twc airtight barriers against release.
6 35.92 Decay-in-storace.
(a) The licensee may hold byproduct material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt f' rom the requirements of 9 20.301 of this chapter if the licensee:
02/08/84 107 Enclosure 1
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(1) Holds byproduct material for decay a minimum of ten (10) half-livest (2) Monitors byproduct material at the container surface prior to disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a low range survey meter set on its most sensitive scale and with no interposed shielding; (3) Removes or obliterates all radiation labels; and (4) Separates and monitors each generator column individually with all radiation shielding removed to ensure that it has decayed to background radiation level prior to disposal.
(b) For paragraph (a) of this section, the licensee shall retain a record of each disposal for two years. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the model number of the survey instrument used, the background radiation exposure rate, the radiation exposure rate measured at the surface of each waste container, and the name of the individual who performed the disposal.
Subpart 0--Uptake, dilution, and excretion (Group General /I) 6 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies.
(a) The licensee may use the following prepared radiopharmaceuticals for diagnostic studies involving the measurement of uptake, dilution, or excretion:
(1) Iodine-131 as sodium iodide, iodinated human serum albumin I
(IHSA), labeled rose bengal, or sodium iodchippurate; l
l 02/08/84 108 Enclosure 1 l i
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(2) Iodine-125 as sodium iodide or iodinated human serum albumin (IHSA);
(3) Cobalt-58 as labeled cyanocobalamin; (4) Cobalt-60 as labeled cyanocobalamin; (5) Chromium-51 as sodium chromate or labeled human serum albumin; (6) Iron-59 as citrate; (7) Technetium-99m as pertechnstate; (8) Any byproduct material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or excretion for which the Food and Drug Administration (FDA) has accepted a " Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a
' New Drug Application" (NOA), or which has been authorized by a Radioactive Drug Research Committee that has been approved by the FDA pursuant to 21 CFR 361.1.
(b) The licensee using a radiopharmaceutical listed in paragraph (a) of this ,section for a clinical procedure other than one specified in the product label or package insert instructions for use shall comply with the product label or package insert instructions regarding physical form, route of administration and dosage range.
1 i
l 6 35.120 Possession of survey instrument.
Each licensee authorized to use byproduct material for uptake, dilution, and excretion studies shall have in his possession a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 mil 11 roentgen per hour.
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1 Subpart E--Imaging and localization (Group II/III) 1 35.200 Use of radienharmaceuticals, generators, and reacent kits for imaging and localization studies.
(a) The licensee may use the following radiopharmaceuticals, generators, and reagent kits for imaging and localization studies:
(1) Molybdenum-99/ technetium-99m generators for the elution or extraction of technetium-99m as pertechnetate; (2) Technetium-99m as. pertechnetate; (3) Prepared radiopharmaceuticals and reagent kits for the preparation of the following technetium-99m labeled radiopharmaceuticals:
(i) Sulfur colloid; (ii) Pentatate sodium; (iii) Human serum albumin microspheres; (iv) Polyphosphate; (v) Macroaggregated human serum albumin; (vi) Etidronate sodium; (vii) Stannous pyrophosphate; (viii) Human serum albumin; (ix) Medronate sodium; (x) Gluceptate sodium; (xi) 0xidronate sodium; (xii) Disofonin; and (xiii) Succiser.
(4) Tin-113/ indium-113e generators for the elution of indium-113m as choride; J l 02/08/84 110 Enclosure 1
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[7590-01]
(5) Iodine-131 as sodium iodide, fodinated human serum albumin, macroaggregated iodinated human serum albumin, colloidal (microaggregated) iodinated human serum albumin, rose bengal, or sodium iodohippurate; (6) Iodine-125 as sodium iodide or fibrinogen; (7) Chromium-51 as human serum albumin; (8) Gold-198 in colloidal form;
- (9) Mercury-197 as chlormerodrin; (10) Selenium-75 as selenomethionine; (11) Strontium-85 as nitrate; (12) Ytterbium-169 as pentetate sodium; (13) Indium-113e as chloride; (14) Xenon-133 as a gas or saline solution; (15) Any byproduct material in a radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing byproduct material for which the Food and Drug Administration has accepted a " Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Orug Application (NOA), or which has been authorized by a Radioactive Drug Research Committee that has been approved by the FDA pursuant to 21 CFR 361.1.
(b) The licensee using the radiopharmaceuticals listed in paragraph (a) of this section for clinical procedures other than those specified in the product label or package insert shall comply with the product label or package insert regarding physical form, route of administration, and dosage range.
(c) The licensee shall elute generators and prepare reagent kits in accordance with the manufacturer's instructions.
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(d) The following radiopharmaceuticals, when used for the listed clinical procedures, are not subject to the restrictions in paragraphs (a) and (b) of this section:
(1) Technetium-99m pentatate as an aerosol for lung function studies.
6 35.204 Permissible molybdenum-99 concentration.
(a) The licensee shall not administer to humans a radiopharma-cautical containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m.
(b) The licensee who prepares technetium-99m radiopharmaceuticals from molybdenum-99/ technetium-99m generators shali measure the molyb-denum-99 concentration in each eluate or extract.
(c) The licensee who must measure molybdenum concentration shall -
also maintain a record of the measure for two years. The record must include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in millicuries, the measured activity of the molybdenum expressed in microcuries, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium, the date of the test, and the initials of the individual who performed the test.
6 35.205 Control of aerosols and cases.
(a) The licensee who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within
\
the limits prescribed by 55 20.103 and 20.106 of this chapter.
l i
1 02/08/84 112 Enclosure 1
[7590-01]
(b) The system must either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.
(c) The licensee shall only administer radioactive aerosols and gases in rooms that are at negative pressure compared to surrounding rooms.
(d) The licenses shall check the operation of collection and I
ventilation systems each six months.
6 35.220 Possession of survey instruments.
Each licensee authorized to use byproduct material for imaging and localization studies shall have in his possession a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour and a portable high level ionization type radiation survey instrument that has a scale with a full scale deflection of 1 roentgen per hour.
Subpart F--Radiopharmaceuticals for therapy (Group IV/V) i 6 35.300 Use of radiopharmaceuticals for theracy.
The licensee may use the following prepared radiopharmaceuticals:
(a) Iodine-131 as iodide for treatment of hyperthyroidism, cardiac dysfunction, and thyroid carcinoma; (b) Phosphorus-32 as soluble phosphate for treatment of polycythemia i
vera, leukemia, and bone metastases; l
02/08/84 113 Enclosure 1
[7590-01]
(c) Phosphorus-32 as colloidal chronic phosphate for intracavitary treatment of malignant effusions; (d) Gold-198 as colloid for intracavitary treatment of malignant effusions; (e) Any byproduct material in a radiopharmaceutical and for a therapeutic use authorized by the Food and Drug Adeinistration.
I 35.310 Safety instruction.
(a) The licensee shall provide oral and written radiation ~ safety instructions for all personnel caring for the patient undergoing radio-pharmaceutical therapy. To satisfy this requirement, the instructions must describe procedures for: '
(1) Patient control;
~'
(2) Visitor contro1; (3) Contamination control; (4) Waste control; and (5) Notification of the radiation safety officer in case of the patient's death or medical emergency.
(b) The licensee shall keep for two years a list of individuals receiving instructions required by paragraph (a) of this section, a description of the instructions, the date of instruction, and the name of the individual who gave the instruction.
I 35.315 Safety precautions.
(a) The licensee shall provide each individual hospitalized for radiopharmaceutical therapy a private room with private sanitary facilities.
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(b) The licenses shall notify the Radiation Safety officer immediately in case of the patient's death or medical emergency.
(c) The licensee shall post the patient's door with a " Radioactive Materials" sign and note in the patient's chart where and how long visitors may stay in the patient's room.
(d) The authorized user and RSO must specifically authorize visits by individuals under age 18 on a case-by-case basis.
(e) The licensee shall either monitor material and items removed from the patient's room to determine that its radioactivity cannot be distinguished from the natural background radiation level with a low range survey meter set on its most sensitive scale and with no interposed
~
shielding, or handle it as radioactive waste.
(f) The licensee shall survey for removable contamination before assigning another patient to the room. The room must not be reassigned until removable contamination is less than 200 disintegrations per 100 1 square centimeters each second.
6 35.320 Possession of survey instruments.
Each licensee authorized to use byproduct material for radiopharmaceutical therapy shall have in his possession a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour and a portable high level ionization type radiation survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour.
02/08/84 115 Enclosure 1
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i l
Subpart G--Sources for brachytherapy (Group'VI) l f 35.400 Use of sources for brachytherapy.
The licensee shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions:
(a) Casium-137 as a ' sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;
! (b) Cobalt-60 as a sealed source in needles and applicator cells '
l for topical, interstitial, and intracavitary treatment of cancer; i
l (c) Gold-198 as a sealed source in seeds for interstitial treat-i ment of cancer; K (d) Iridium-132asseedsencasedinnylonribbonor for terstitial treatment of cancer;
['
d (e) Strontium-90 as a sealed source in an applicator for, treatment
% of superficial eye conditions;-
NN C~I (f) Iodine-125 as a sealed source in seeds for interstitial treatment 5 of cancer; and g)j Tantalum-182 as wire 6 35.404 Release of patients treated with temporary implants.
(a) The licensee shall not release from confinement for medical care a patient treated by the temporary implant of a source listed in j $ 35.400 until a radiation survey of the patient is made to confirm that all sources have been removed.
i (b) The licensee shall retain a record of patient surveys for two years. Each record must include the name of the patient and the exposure l rate from the patient expressed as millirem per hour and measured within one meter of the patient.
2/1/84 116 Enclosure 1
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1 35.406. Brachytheracy sources inventory.
1 (a) Each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall immediately count the number returned to ensure that all sources taken from the storage area have been returned.
(b) The licensee shall make a record of brachytherapy source use which must include:
(1) The names of the individuals permitted to handle the sources, (2) The number and activity of sources removed from storage, the room number of use or patient's name, the time and date they were removed from storage, the number and activity of the sources in storage after the removal, and the initials of the individual who emoved the sources from storage; (3) The number and activity of sources returned from use, the room number of use or patient's name, the time and date they were returned to storage, the number and activity of sources in storage after the return, 1
and the initials of the individual who returned the sources to storage.
(c) The licensee shall retain the record required in paragraph (b) of this section for two years.
t 6 35.410 Safety instruction.
(a) The itcensee shall provide written radiation safety instruc-l tions to all individuals caring for the patient undergoing implant therapy. To satisfy this requirement, the instructions must describe:
I -
(1) Size and appearance of the brachytherapy sources; i
02/08/84 117 Enclosure 1
[7590-01]
(2) Safe handling and shielding instructions in case of a dislodged source; (3) Procedures for patient control; (4) Procedures for visitor control; and (5) Procedures for notification of the Radiation Safety Officer in case of the patient's death or medical emergency.
(b) The licensee shall retain for two years a record of individuals receiving instructions required by paragraph (a) of this section, a description of the instructions, the date of instruction, and the name of the individual who gave the instruction.
f 35I.415 (afetyprecautions.
(a) The licensee shall provide each individual hospitalized for implant a private room. -
(b) The licensee shall notify the Radiation Safety Officer immediately in case of the patient'., death or medical emergency.
(c) The licensee shall post the patient's door with a " Radioactive Materials" sign and note in the patient's chart where and how long visitors may stay in the patient's room.
I (d) The authorized user and RSC must specifically authorize visits by individuals under age 18 on a case-by-case basis.
l 6 35.420 Possession of survey instrument.
i Each licensee authorized to use byproduct material for implant therapy shall have in his possession a portable high level ionization type radiation survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour.
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[7590-01]
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Subpart H--Sealed sources for diagnosis (Group VII)
I 35.500 Use of sealed sources for diacnosis. .
The licensee shall use the following sealed sources in accordance with the manufacturer's radiation safety and handling instructions:
t (a) Iodine-125 as a sealed source in a device for bone mineral e{.S' analysis; (b) Americium-241 as a sealed source in a device for bone mineral analysis; and (c) Iodine-125 as a sealed source in a portable device for imaging.
I 35.520 Availability of survey instrument.
Each licensee authorized to use byproduct material as a sealed
, source for diagnostic purposes shall have available for use a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 mil 11 roentgen per hour or a portable high leve1' ionization type radiation survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour that has been calibrated in accordance with 5 35.51 of this part.
Subpart I--Teletherapy (Group VIII) i 6 35.600 Use of a sealed source in a teletherapy unit.
The regulations and provisions of this subpart govern the use of teletherapy units that contain the following sources for the treatment of humans:
02/08/84 119 Enclosure 1
[7590-013 (a) Cobalt-60 as a sealed source; and (b) Cesium-137 as a sealed source.
I 35.605 Maintenance and repair restrictions.
Only a person specifically licensed by the NRC or an Agreement State to perform teletherapy unit maintenance and repair shall install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source or maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels.
I 35.606 Amendments.
The licensee shall apply for and must receive a license amendment prior to:
(a) Making any change in the treatment room shielding; (b) Making any change in the location of the teletherapy unit within the treatment room; (c) Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room; (d) Relocating the teletherapy unit; (e) Removing the teletherapy unit; or (f) Allowing an individual not listed on the licensee's license to perform the duties of the qualified teletherapy calibration expert.
4 1
02/08/84 120 Enclosure 1
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[7590-013 6 35.610 Safety instruction.
(a) The licensee shall post written instructions at the teletherapy unit console. To satisfy this requirement, these instructions must inform the operator of:
(1) The procedure to be followed to ensure that only the patient is in the treatment room before turning the primary beam of radiation on; (2) The procedure to be followed if:
(i) the operator is unable to turn the primary beam of radiation off with controls outside the treatment room; or (ii) any other abnormal operation occurs; and (iii) The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted in the event of any abnormal operation of the telethe'rapy unit or console.
(b) The licensee shall provide instruction in the topics identified in paragraph (a) of this section to all individuals who operate a teletherapy i
unit.
! (c) The licensee shall retain for two years a record of individuals receiving instructions required by paragraph (b) of this section, a description of the instructions, the date of instruction, and the name of the individual who gave the instruction.
6 35.615 Doors, interlocks, and warnino systems.
(a) The licensee shall control access to the teletherapy room by a door at each entrance.
(b) The licensee shall equip each entrance to the teletherapy room with an electrical interlock system that will:
02/08/84 121 Enclosure 1
[7590-01]
(1) Prevent the operator from turning the primary beam of radiation on unless each treatment room entrance door is closed; (2) Turn the primary beam of radiation off immediately when an entrance door is opened; and (3) Prevent th; irimary beam of radiation from being turned on following an interlock interruption until all trestment room entrance doors are closed and the beam on-off control is reset at the console.
(c) The licensee shall equip each entrance to the teletherapy room with a beam condition indicator light.
6 35.620 Possession of survey instrument.
Each licensee who is authorized to use byproduct material in a teletherapy unit shall have in his possession either a portable low level radiation survey instrument whose most sensitive scal,e has a full-scale deflection of not more than 1 milliroentgen per hour or a
- portable high level ionization type radiation survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour.
1 35.621 Radiation monitorina device.
(a) The licensee shall install a permanent radiation monitor in
! each teletherapy room capable of continuously monitoring beam status.
, (b) Each radiation monitor must be capable of providing visible notice of a teletherapy unit malfunction that may result in an exposed ,
l i
or partially exposed source. The visible indicator of high radiation !
levels must be observable by an individual entering the teletherapy 1
I room.
02/08/84 122 Enclosure 1 i
[7590-01]
l (c)- Each radiation monitor must be equipped with an emergency power supply separate from the power supply to the teletherapy unit.
This emergency power supply may be a battery system.
(d) Each radiation monitor must be checked for proper operation each day before the teletherapy unit is used for treatment of patients.
(e) The licensee shall maintain a record of the check required by paragraph (d) of this section for two years. The record must include the date of the check, notation that the monitor indicates when the source is and is not exposed, and the initials of the individual who performed the check. *
(f) If a radiation monitor is inoperable for any reason, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked for proper operation at the beginning of each day of use.
(g) The licensee shall promptly repair or replace the radiation monitor if it is inoperable.
6 35.622 Viewina system.
The licensee shall construct or equip each teletherapy room to l permit continuous observation of the patient from the teletherapy unit console during f* radiation.
4 i
j 02/08/84 123 Enclosure 1 I
[7590-01]
l 6 35.630 Dosimetry equipment.
(a) The licensee shall have a calibrated dosimetry system available l
' for use. To satisfy this requirement, one of the following two conditions l sust be met.
(1) The system must have been calibrated by the National Bureau of Standards or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration must have been I performed within the previous two years and after any servicing that may have affected system calibration; or (2) The system must have been calibrated within the previous four years; eighteen to thirty months aftsr that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the National Bureau of Standards or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). 1 The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee shall not use the intercomparison result to change the calibration i
factor. The licensee shall use a teletherapy unit with a cobalt-60 i
source when intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, and a teletherapy unit with a cesium-137 source when intercomparing dosimetry systems to be used for calibrating casium-137 teletherapy units.
(b) The licensee shall have available for use a dosimetry system for spot-check measurements. To satisfy this requirement, the system 02/08/84 124 Enclosure 1 4
--w, -- - , . . - --- -- - - , _ _ - - -
[7590-01]
2 may be compared with a system that has been calibrated in accordance with paragraph .(a) of this section. This comparison must have been performa$ within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement *in paragraph (a) of this section.
(c) The licensee shall retain a record of each calibration, inter-comparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instrument that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of this section, the correction factors that were deduced, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by '
AAPM. .
A i
6 35.632 Full calibration measurements.
(a) Any licensee authorized to use a teletherapy unit for treating humans shall perform full calibration measurements on each teletherapy unit:
(1) Before the first use of the unit for treating humans; and (2) Before treating humans under the following conditions:
(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for physical decay; 02/08/84 125 Enclosure 1
-z.
(7590-01]
(ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; (iii) Following any repair of 'the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and (3) At intervals not exceeding one year.
(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of:
(1) The output within 13 percent for the range of field sizes and for the distance or range of distances used in radiation therapy; (2) The coincidence of the radiation field and the field indicated by the light beam localizing device; I
(3) The uniformity of the radiation field and its dependence on the orientation of the useful beam; (4) Timer accuracy; (5) On-off error; and (6) The accuracy of all distance measuring and localization devices used for treating humans.
(c) The licensee shall use the dosimetry system described in 5 35.630(a) to measure the output for one set of exposure conditions.
The radiation measurements required in paragraph (b)(1) of snis section may then be made using a dosimetry system that indicates relative dose rates.
(d) The licensee shall make full calibration measurements required by-paragraph (a) of this section in accordance with the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine. These procedures are 02/08/84 126 Enclosure 1
[7590-01]
described in Physics in Medicine and Biolocy Vol. 16, No. 3, 1971, pp. 379-396, which has been approved for incorporation by reference by the Director of the Federal Register. Copies of the document are avail-able for inspection or may be obtained from the U.S. Nuclear Regulatory Commission, Public Document Room, 1717 H Street NW, Washington, D.C.
20555. A copy of the document is also on file at the Office of the
, Federal Register, 1100 L Street NW., Room 8301, Washington, D.C. 20408.
A notice of any change in the material will be published in the Federal Register.
(e) The licensee shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding one month.
(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by a qualified teletherapy calibration expert.
(g) The licensee shall retain a record of each calibration for the duration of the license. The record must include the date of the cali-bration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a radiograph l of a single field with the location of the light field indicated on the radiograph, the measured timer accuracy for a typical treatment time, the calculated on-off error, the estimated accuracy of each distance 02/08/84 127 Enclosure 1
[7590-01]
measuring or localization device, and the signature of the qualified teletherapy calibration expert.
I 35.633 Periodic spot-checks.
(a) The licensee authorized to use taletherapy units for treating humans shall perform spot-checks on each teletherapy unit once in each calendar month.
(b) To satisfy the requirement of paragraph (a) of this section.
I measurements must include determination of:
(1) Timer accuracy; (2) On-off error; (3) The coincidence of the radiation field and the field indicated by the light beam localizing device; (4) The accuracy of all disi.ance measuring and localization devices used for treating humans; (5) The output for one typical set of operating conditions; and (6) The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output'(i.e., the value obtained at last full calibration corrected mathematically for physical decay).
(c) The licensee shall use the dosimetry system described in 6 35.630(b) to make the measurement required in paragraph (b)(5) of this j section.
(d) The licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the qualified teletherapy calibration expert. That individual need not actually perform the spot-check measurements.
)
02/08/84 128 Enclosure 1
[7590-01]
(e) The Itcensee shall have the qualified teletherapy calibration expert review the results of each spot-check within 15 days. The quali-fied teletherapy calibration expert shall p'romptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for two years.
(f) The licensee authorized to use a teletherapy unit for treating humans shall perform spot-checks of each teletherapy facility at intervals not exceeding one month.
(g) To satisfy the requirement of paragraph (f) of this section, checks must assure proper operation of:
(1) Electrical interlocks at each teletherapy room entrance; (2) The function of electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and cperation of the beam on-off mechanism);
(3) All beam condition indicator lights on the taletherapy unit, on the control console, and in the facility; (4) The viewing system; '
(5) Operability of treatment room doors from inside and outside the treatment room; and l (6) Operability of any electrically assisted treatment room doors l
with the teletherapy unit electrical power turned off.
(h) The licensee shall lock the control console in the off position if any door interlock malfunctions, and shall not use the unit until the interlock system is repaired.
(1) The licensee shall promptly repair any system identified in paragraph (g) of this section that is not operating properly.
l 02/08/84 129 Enclosure 1
~
[7590-01]
(j) The licensee shall retain a record of each spot-check required by paragraphs (a) and (f) of this section for two years. The record must include the date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit and source, the mai.ufacture?'s name, acdel number and serial number of the instrument used to measure the output of the teletherapy unit, the measured timer accuracy, the calculated on-off error, a radiograph of a single field with the location of the light field indicated on the raciagraph, the measured timer accuracy for a typical treatment time, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, the difference between the anticipated output and _
the measured output, nota'tions indicating the operability of e.ach entrance door electrical interlock, each electrical or mechanical step, each beam condi, tion indicator light, the viewing system and doors, and the signature-of the individual who performed the periodic spot-check.
6 35.641 Radiation surveys for teletheracy facilities.
(a) Before human use, after each installation of a/celetherapy source, and after making any change for which an ame.ndmont is required by 5 35.606(a)-(d),the licensee shall perform radiatio l.1 surveys to
'~
verify that: f (1) The maximum and average radiation levels a% one meter from the teletherapy source when in the off position do not fxceed 10 millircentgens per hour and 2 milliroentgens per hour, respectively; and (2) With the teletherapy source in tha on pfsition with the largest clinically available treatment field and with a phantom in the primary beam of radiation, that 2 02/08/84 130 Enclosure 1
[7590-01]
(i) Radiation quantities in restricted areas adjacent to the treatment room are not likely to cause personnel exposures in excess of the limits specified in 5 20.101 of this chapter, and (ii) Radiation quantities in unrestricted areas adjacent to the treatment rcos do not exceed the limits specified in 5 20.105(b) of this chapter.
(b) If the results of the surveys required in paragraph (a) of this section indicate any radiation quantity in excess of the respective limit specified in.that paragraph, the licensee shall lock the control in the off position and not use the unit:
(1) Except as may be necessary to repair, replace, or test the
- - -taletherapy unit shielding or the treatment room shielding; or 4
(2) Until the licensee has received a specific exenption pursuant to 5 20.501 of this chapter.
~
(c) The licensee shall maintain a record of the radiation measurements made following installation of a source: for the duration of the liennse.
The record must include the date of the measurements, the reason the survey is raquired, the manufacturer's name, model number and serial number of tae teletherapy unit, the source, and the instrument used to measure radiation levels, each radiation level measured a.round the tel'a-c therapy source while in the off positien and the average of all mensura- '
i ments, a pl an of each area that was surveyed, the measured exposura rate
\
at several points in each area expressed in millirem per hour, the l calculated maximum quantity of radiation over a period of one weet fo'-
each restri.:ted and unrestricted area., and the signature of the Radia, tion Safety Offi::er. l l
i 02/08/84 131 Enclosbre1 l
e
[7590-01]
- 'E 35.642 Safety checks for teletheracy facilities.
(a) The licensee shall promptly test all systems listed in 5 35.633(g) for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by $ 35.606(a)-(d).
l (b) If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system specified in f 35.633(g),
the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or test the malfunctioning system.
(c) The licenses shall retain a record of the facility checks following installation of a source for two years. The record must include notations indicating the operability of each entrance door l
interlock, each electrical or mechanical stop, each beam condition indi-cator light, the viewing system, and doors, and the signature of the Radiation Safety Officer.
i 6 35.643 Modification of teletherapy unit or room-before beginnina a treatment procram.
I If the survey required by 9 35.641 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 9 20.105(b) of this chapter, before beginning the i
treatment program the licenses shall:
(a) Either equip the unit with stops or add additional radiation shielding to ensure compliance with 9 20.105; (b) Perform the survey required by 5 35.641 again; and l
02/08/84 132 Enclosure 1
[7590-01]
(c) Include in the report required by 5 35.644 the results of the initial survey, a description of the modification, and the results of the second survey.
6 35.644 Reports of teletherapy surveys, checks, tests, and measurements.
The licensee shall mail an original and a copy of the results of the records required in 55 35.641, 35.642, 35.643, and the output from the teletherapy source expressed as Roentgens per hour at a distance of one meter from the source and determined during the full calibration required in 5 35.632, to the appropriate U.S. Nuclear Regulatory Commission Regional Office listed in 535.16 of this Part within thirty days following completion of the action which initiated the record requirement.
6 35.645 Five-year insoection.
(a) The licensee shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.
(b) This inspection and servicing may only be performed by persons specifically' licensed to do so by the Commission or an Agreement State.
(c) The licensee shall keep a record of the inspection and servicing for the duration of the license. The record must contain the inspector's name, the inspector's license number, the date of inspection, the manufac- .
turer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector.
02/08/84 133 Enclosure 1
[7590-01]
(d) Amendments to teletherapy licenses that extenced the time interval for the inspection and servicing requirement of paragraph (a) of this section that were in effect on March 4, 1983 remain in effect and are not rescinded by this section.
Subpart J--Training and Experience Requirements 1 35.900 Radiation Safety Officer.
Except as provided in 5 35.901, the licensee shall require an indi-vidual fulfilling the responsibilities of the Radiation Safety Officer as provided in 6 35.32 to:
(a) Se certifie.d by:
(1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Medical Nuclear Physics; or (3) American Boted of Nuclear Medicine Science in Nuclear Medicine Science; or (b) Be an authorized user for those byproduct material uses that come within the Radiation Safety Officer's responsibilities; or (c) Have had 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training and one year of experience as follows:
(1) 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> of radiation pnysics and instrumentation; (2) 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> of radiation protection; (3) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of mathematics pertaining to the use and measurement of radioactivity; 02/08/84 134 Enclosure 1
[7590-01]
(4) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of radiation biology; (5) 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> of radiopharmaceutical chemistry; and (6) One year of full time experience in medical radiation safety at an institution under the supervision of the individual listed as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the human use of byproduct material.
(d) The training and experience specified in paragraph (c) of this section must have been obtained within the five years preceding the date of application or the Radiation Safety Officer must have had experience equivalent to one year of full time employment in medical radiation safety within the last five years.
6 35.901 Radiation Safety Officer training exception.
An individual identified as a Radiation Safety Officer on a Commission or Agreement State license on (*** insert effective date of final rule
- ), who oversees only the use of byproduct material for which the licensee was authorized on that date, need not comply with the training requirements of 8 35.900.
t i 6 35.910 Traininc for uptake, dilution, and excretion studies.
Except as provided in 89 35.970 and 35.971, the licensee shall require the authorized user of a radiopharmaceutical listed in 5 35.100(a) to be a physician who:
(a) Is certified in:
(1) Nuclear medicine by the American Board of Nuclear Medicine; or l
(2) Diagnostic radiology with special competence in nuclear radiology by the American Board of Rar'iology; or 02/08/84 135 Enclosure 1 l
. _ - . . ~_- - . _ . . - ._ _ _-.
~
[7590-013 (3) Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or (b) Has completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of training in basic radioisotope i
handling techniques applicable to the use of prepared radiopharmaceuticals, and 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of supervized clinical experience. To satisfy the basic training requirement, the training must include classroom and laboratory instruction and supervised experience in a nuclear medicine laboratory as follows:
(1) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> of radiation physics and instrumentation; (2) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> of radiation protection; (3) 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> of mathematics pertaining to the use and measurement of radioactivity; -
(4) 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> of radiation biology; and
' (5) 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> of radiopharmacedical chemistry; or (c) Has successfully completed a six-month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section within five years of the date of application for a license,
- or have had experience equivalent to one year of full time employment in nuclear medicine within the last five years.
)
6 35.920 Training for imacino and localization studies.
Except as provided in 5 35.970 or 35.971, the licensee shall require .
l the authorized user of a radiopharmaceutical, generator, or reagent kit '
listed in 3 35.200(a) to be,a physician who:
02/08/84 136 Enclosure 1 3 - - , ..--. -- , ,, ,--,o,
1
[7590-01] j (a) Is certified in: l 1
(1) Nuclear medicine by the American Board of Nuclear Medicine; or (2) Diagnostic radiology with special competence in nuclear radiology !
by the American Board of Radiology; or (3) Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or
~
(b) Has completed 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of instruction in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuti-cals, generators, and reagent kits, 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experi-ence and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised clinical experience.
(1) To satisfy the requirement for instruction, the classroom and laboratory training must include:
(i) 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> of radiation physics and instrumentation; (ii) 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> of radiation protection; (iii) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of mathematics pertaining to the use and measurement of radioactivity; (iv) 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> of radiopharmaceutical chemistry, and (v) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of radiation biology.
l (2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at an institution and must include:
l (i) Ordering, receiving and unpacking radioactive materials safely l
l and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meter; (iii) Calculating and safely preparing patient dosages; (iv) Using administrative controls to prevent the misadministration 1
02/08/84 137 Enclosure 1
[7590-013 of byproduct material; 4
- (v) Using emergency procedures to handle and contain spilled byproduct material safely and using proper decontamination procedures; f
and (vi) Eluting technetium-99m from generator systems, assaying and testing the eluate for molybdenum-99 and alumina contamination, and processing the aluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals. .
, (3) To satisfy the requirement for supervised clinical experience, training must be under the supervision of an authorized user at an institution and must inglude:
(i) Examining patients and reviewing their case histories to i
determine their suitability for radioisotope diagnosis, limitations or contraindications; -
(ii) Selecting the proper radiopharmaceutical and calculating the dosage; (iii) Administering dosages to patients and making proper use of syringe radiation sh* elds; (iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and (v) Patient followup; or (c) Has successfully completed a six-month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the l topics identified in paragraph (b) of this section within five years of I
02/08/84 138 Enclosure 1
[7590-01]
the date of application for a license, or have had experience equivalent to one year of full time employment in nuclear medicine within the last five years.
1 35.930 Trainina for therapeutic use of radiopharmaceuticals.
Except as provided in 3 35.970, the licensee shall require the authorized user of a radiopharmaceutical listed in 5 35.300 for therapy to be a physictan who:
(a) Is certified in nuclear medicine by the American Board of Nuclear Medicine; or (b) Has completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of instruction in basic radioisotope handling techniques applicable to the use of therapeutic radiophar-maceuticals, and have had supervised clinical experience.
1 (1) To satisfy the requirement for instruction, the classroom and
,. laboratory training must include:
(i) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> of radiation physics and instrumentation; (ii) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> of radiation protection; (iii) 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> of mathematics pertaining to the use and measurement i
of radioactivity; and (iv) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of radiation biology; (2) To satisfy the requirement for supervised clinical experience, training must be under the supervision of an authorized user at an institution and must include:
(i) Use of iodine-131 for diagnosis of thyroid function and the I
treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; (ii) Use of soluble phosphorus-32 for the treatment of polycythemia vera, leukemia, or bone metastases in 3 individuals; l
02/08/84 139 Enclosure 1
- - - - - = we---,r--e-iy-,,w-e-ee----w ee- -aw- - - - - - - , - - ,~ .- ---ww ar-wr--,w- --- ,- w-, - - _ - -w--- --e- r== - , -, - --e------ --- -- - - - - - - - - - - - -
l
[7590-01] l (iii) Use of colloidal phosphorus-32 for intracavitary treatment of malignant effusions in 3 individuals; (iv) Use of iodine-131 for treatment of thyroid carcinosa in 3 individuals; and l (v) Use of colloidal gold-198 for intracavitarf treatment of malignant effusions in 3 individuals. .
E 35.940 Trainina for therapeutic use of brachytheraov sources.
Except as provided in 5 35.970, the licensee shall require the authorized user using a brachytherapy source listed in 5 35.400 for 4
therapy to be a physician who:
(a) Is certified in:
, (1) Radiology or therapeutic radiology by the .berican Board of.
' Radiology; 3 (2) Radiation oncology by the American Osteopathic Board of Radiology; (3) Radiology, with a specialization in radiotherapy, as a British
" Fellow of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or l (b) Has completed 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of instruction in basic radioisotope j handling techniques applicable to the therapeutic use of brachytherapy i sources and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience and three years of supervised clinical experience.
l (1) To satisfy the requirement for instruction, the classroom and
! laboratory training must include:
l 02/08/84 140 Enclosure 1 ,
_ . _ _ _ _. _ _ . _ _ . ~
. [7590-01]
(i) 110 hours0.00127 days <br />0.0306 hours <br />1.818783e-4 weeks <br />4.1855e-5 months <br /> of radiation physics and instrumentation;
- (ii) 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of radiation protection; (iii) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> of mathematics pertaining to the use and measurement of radioactivity; and (iv) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> of radiation biology.
(2) To satisfy the requirement for supervised work experience, 4
training must be under the supervision of an authorized user at an institution and must include:
(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Checking surysy meters for proper operation; (iii) Preparing, implanting and removing sealed sources safely; t
(iv) Using administrative controls to prevent the misadministration
- of byproduct material; and (v) Using emergency procedures to handle and control byproduct material.
(3) To satisfy the requirement for a period of supervised clinical
, experience, training must include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accredi-tation Council for Graduate Medical Education, and an additional two years of clinical experience in therapeutic radiology under the supervi-sion of an authorized user at an institution.
6 35.941 Trainina for ophthalmic use of strontium-90.
Except as provided in 5 35.970, the licensee shall require the
! authorized user using only strontium-90 for ophthalmic radiotherapy to be a physician who:
02/08/84 141 Enclosure 1
[7590'-01] .
I l
(a) Is certified in radiology or therapeutic radiology by the American Board of Radiology; or l
{ (b) Has completed 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of instruction in basic radioisotope handling techniques specifically applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of iupervised clinical training
- in ophthalmic radiotherapy. ,
(1) To satisfy the requirement for instruction, the classroom and laboratory training must include: I (1) 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> of radiation physics and instrumentation; (ii) 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> of radiation protection; (iii) _4_ hours of mathematics pertaining to the use and measurement 4
of radioactivity; and (iv) 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of radiation biology.
(2) To satisfy the requirement for a period of supervised clinical training in ophthalmic radiotherapy, training must be under the super-vision of an authorized user at an institution and must include the use of strontium-90 for the ophthalmic treatment of five individuals and must include the examination of each individual to be treated, calculation of the dose to be administered, administration of the dose, post-administra-
! tion followup, and review of each individual's case history.
1 q 35.950 Trainino for use of sealed sources for diaanosis.
Except as provided in f 35.970, the licensee shall require the authorized user using a sealed source in a device listed in 5 35.500 to be a physician, dentist, or podiatrist who:
(a) Is certified in 02/08/84 142 Enclosure 1
. _ _ _ . . _ . _ _ _ . - . - . _ _ _ . _ . _ ~ - -
[7590-01]
(1) Radiology, diagnostic radiology with special competence on nuclear radiology, or therapeutic radiology by the American Board of Radiology; or (2) Nuclear medicine by the American Board of Nuclear Medicine; or (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or ,
(b) Has completed 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of instruction in basic radioisotope handling techniques specifically applicable to the use of the device .
To satisfy the requirement for instruction, the training must include:
(1) 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> of radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumenta' tion; (2) 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> of radiation biology; and (3) 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> of radiation protection and training in the use of the device for the purposes authorized by the license.
I 35.960 Traininc for taletherapy.
Except as provided in 5 35.970, the licensee shall require the authorized user using a sealed source listed in f 35.600 in a taletherapy unit to be a physician who:
(a) Is certified in:
(1) Radiology or therapeutic radiology by the American Board of Radiology; or (2) Radiation oncology by the American Osteopathic Board of Radiology; or (3) Radiology, with specialization in radiotherapy, as a British
" Fellow of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or 02/08/84 143 Enclosure 1
)
[7590-013 (4) Therapeutic radiology by the Canadian Royal College of Physicians I i
and Surgeons; or <
(b) Has completed 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of instruction in basic radioisotope techniques applicable to the use of a sealed source in a teletherapy unit 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, and three years of super-vised clinical experience. I I
l (1) To satisfy the requirement for instruction, the classroom and I
laboratory training must include:
1 I
(i) 110 hours0.00127 days <br />0.0306 hours <br />1.818783e-4 weeks <br />4.1855e-5 months <br /> of radiation physics and instrumentation; l (ii) 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of radiation protection; (iii) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> of mathematics pertaining to the use and measurement of radioactivity; and (iv) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> of radiation biology.
(2) To satisfy the requirement for supervised work experience, l
[, , training must be under the supervision of an authorized user at an institution and must include:
(1) Review of the full calibration measurements and periodic spot checks; (ii) Preparing treatment plans and calculating treatment times; (iii) Using administrative controls to prevent misadministrations; (iv) Implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and (v) Checking and using survey meters.
(3) To satisfy the requirement for supervised clinical experience, training under the supervision of an authorized user must include:
02/08/84 144 Enclosure 1 I
t
[7590-01] ,
l (1) Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications; !
(ii) Selecting the proper dose and how it is to be administered; (iii) Calculating the teletherapy doses and collaborating with the -
authorized user in the review of patients' progress and consideration of the need to modify originally prescribed dose as warranted by patients' reaction to radiation; and (iv) Post-administration followup and review of case histories.
6 35.961 Trainina for cualified teletherapy calibration expert.
The licensee shall require the individual ' calibrating or checking the radiation output of a teletherapy unit as a qualified teletherapy calibration expert as provided by II 35.632 and 35.633 to:
(a) Be certified by the American Board.of Radiology in:
(1) Therapeutic radiological physics; or (2) Roentgen ray and gamma ray physics; or (3) X-ray and radium physics; or (4) Radiological physics; or l
(b) Hold a master's or doctor's degree in physics, biophysics, i
radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a qualified teletherapy I
calibration expert at an institution where teletherapy is performed. To satisfy this requirement, the neophyte qualified teletherapy calibration l
l 02/08/84 145 Enclosure 1 I
w .,_.---- _ _ /
[7590-01]
expert must have performed the tasks listed in SS 35.59, 35.632, 35.633, and 35.641 of this part under the supervision of a qualified teletherapy calibration expert during the year of work experience.
6 35.970 Experienced authorized user trainino exception.
A physician, dentist, or podiatrist identified as an authorized
~
user for the human use of byproduct material on a Commission or Agreement State license on (*** insert effective date of final rule ***) who performs only those methods of use for which he was authorized on that date need not comply with the training requirements of Subpart J.
6 35.971 New physician trainino exception.
A physician who, by August 31, 1987, has successfully completed a three month nuclear medicine training program approved by the Accredita-tion Council for Graduate Medical Education need not comply with the requirements of $$ 35.910 or 35.920.
Subpart K--Enforcement 6 35.990 Violations.
(a) An injunction or other court order may be obtained to prohibit
. violation of any provision of:
(1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974; or (3) Any regulation or order issued under these Acts.
(b) A court order may be obtained for the payment of a civil penalty imposed for violation of:
02/08/84 146 Enclosure 1 N
[7590-01]
f (1) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 under section 234 of the Atomic Energy Act of 1954; (2) Section 206 of the Energy Reorganization Act of 1974; (3) Any rule, regulation, or order issued under these Acts; (4) Any term, condition, or limitation of any license issued under these Acts; or
- (5) Any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954.
j (c) Any person who willfully violates any provision of the Atomic Energy Act of 1954, as amended, or any regulation or order issued under j the requirements of the Act :tay be guilty of a crime and, upon conviction, may be punished by fine or imprisonment or both as provided by law.
Regulations issued under the Act include regulations issued under sec.161, and cited in the authority citation at the beginning of this part for the purposes of sec. 223.
The following amendments are also made to existing parts of the regulations in this chapter. The authority for these conforming amendments
l sec. 201, Pub. L.93-438, 88 Stat.1242, as amended (42 U.S.C. 5841).
PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF l BYPRODUCT MATERIAL i
- 2. Section 30.4 is amended by revising paragraphs (h) and (1) to read as follows and by adding new paragraphs (x) and (y) as follows: ,
! 6 30.4 Definitions.
n n n a n I
l l 02/08/84 147 Enclosure 1
[7590-01]
)(,
uW (h) " Human use" means the intential internal or external administration of byproduct material, or the radiation therefrom, to human beings in the practice of medicine in accordance with a license issued by a State or Territory of the United States, the District 'of Columbia, or the Commonwealth of Puerto Rico in the art of medicine.
n n a n n (1) " Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory'of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine; a n a n n (x) " Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Pua.rto Rico to practice the art of dentistry on humans.
(y) '" Podiatrist" means an individual licensed by a State or Territsry of the United States, the District of Columbia, or the Common-wealth of Puerto Rico to practice the art of podiatry on humans.
n n a n a
- 3. Section 30.34 is amended by revising paragraph (g) to read as follows:
6 30.34 Terms and conditions of licenses.
n a a a n (g) A licensee may prepare technetium-99m radiopharmaceuticals only with technetium-99m that contains less than 0.15 microcuries of molybdenum-99 per mil 11 curie of technetium-99m. The licensee shall
'[ perform tests and maintain the records required by 9 35.204 g M 02/08/84 148 Enclosure 1
[7590-01] )
PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL 6 31.11 [Amendedl n a n n a 4.
Section 31.11(b) is revised to read as follows:
(b) No person shall receive, acquire, possess, use, or transfer byproduct material pursuant to the general license established by paragraph (a) of this section until he has filed form NRC-483, " Registration Certificate-In Vitro Testing with Byproduct Material Under General License," with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C.
20555 and received from the Commission a validated copy of Form NRC-483 with registration number assigned, or unless he has a license that authorizes the human use of byproduct material and that expires before [*** insert five years after effective date of final rule ***],
or unless he has a license that authorizes the human use of byproduct material and also authorizes the use of byproduct material consistent with the requirements of this section.
n n a n a PART 32 - SPECIFIC DOMESTIC LICENSE TO MANUFACTURE OR TRANSFERCERTAINITEMSdONTAININGBYPRODUCTMATERIALS i
l 6 32.70 (Removed]
l S. Section 32.70 is removed. -
- 6. In 5 32.72 the introductory text of paragraph (a) and para- ,
i graph (a)(4)(1) are revised to read as follows:
l l
i l 02/08/84 149 Enclosure 1
[7590+01]
1 32.72 Manufacture and distribution of radiopharmaceuticals containina byproduct material for medical use under aroup licenses.
(a) An application for a specific license to manufacture and distribute radiopharmaceuticals containing byproduct material for use by persons authorized pursuant to Part 35 of this chapter will be approved if:
a a n a n (4)(1) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay, and the label affixed to each package, or the leaflet or brochure that
- accompanies each package, contains a statement that the radiopharmaceuti-cal is licensed by the U.S. Nuclear Regulatory Commission for distribu-
, tion to persons licensed to use byproduct material listed in $$ 35.100, 35.200, or 35.300, as appropriate, or under an equivalent license of an Agreement State. .
. n a n n n
- /
- j 7. In 5 32.73 paragraph (a)(5)(ii) is revised to read as follows
e /
6 32.73 Manufacture and distribution of cenerators or rescent kits for l
preparation of radiopharmaceutical containing t,yproduct material.
(a)
(5) ***
i (ii) A statement that this generator or reagent kit (as appropriate)
I is approved for distribution to persons licensed by the U.S. Nuclear
[ p,,<tf Regulatory Commission to use byproduct material identified in 5 35.200
. ~ . -
/ (flCFR Part 3Mor under an equivalent license of an Agreement State.
[c / n a n a n
)
l l
l 02/08/84 150 Enclosure 1 l
' ~ _ - _ _ _ _ _ _ _ _ _ . _ .
1
[7590-01] l
- 8. In 5 32.74 the introductory text of paragraph (a) and para-graph (a)(3) are revised to read as follows:
6 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use.
(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to Part 35 of this chapter for use as a calibration or
~
reference source or for the uses listed in SS 35.400 and 35.500 of this chapter will be approved if:
a a a a =
(3) The label affixed to the source.or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the (name of source or device) is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed to use byproduct material identified
[
in 95 35.58, 35.400, or 35.500, as appropriate,ch CFR Part 35')or underMM an equivalent license of an Agreement State. yJ}n 5 52.72-n a n a n PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL
- 9. Section 40.4 is amended by revising paragraph (g) to read as follows:
66 40.4 Definitions.
n n a n n (g) " Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of 02/08/84 151 Enclosure 1
(
l
[7590-01] . I Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the l
practice of medicine; I n a a a a t Dated at Washington, D.C. this day of 198[. )(
For the Nuclear Regulatory Commission.
Samuel J. Chilk, Secretary of the Commission.
L 02/08/84 152 Enclosure 1
____ _ _ _ _ _ _ _--- - - ---A
r ]
- f
-l PERIODIC AND SYSTEMATIC REVIEW - 10 CFR PART 35 Introduction Task IV G.2 of the TMI Action Plan directed the staff to review all existing regulations for content, quality and clarity. SECY 81-435 and 435A established specific' review criteria and created the Regulations Coordinating Committee (RCC) to plan, schedule, and coordinate the review. Under the RCC charter, one guideline for setting the-priority of specific regulations for review was a Commission or staff initiative for a major revision of an existing rule. The Periodic and Systematic Review of 10 CFR Part 35 is in response to a staff decision that a substantial revision of the human use licensing require-ments of Part 35 was necessary.
It should be noted that the re-evaluation of Part 35 does not address the misadministration sections of the current rule ($$ 35.41 - 35.44). When these provisions were first promulgated, the Commission established a specific time period for their evaluation. Due to this separate time period and the unique nature of the misadministration issue, the proposed revision to Part 35 and this Periodic and Systematic Review do not include this rabject within their scope of analysis.
Analysis
- 1. The Need for the Regulation.
Under 10 CFR Part 35, the NRC issues licenses to hospitals and physicians for the use of radioactive materials for diagnostic and therapeutic purposes.
The NRC currently has approximately 2600 medical licensees, and 15 to 20 million nuclear medicine procedures are performed in the United States each year. .The proposed facilities, personnel, program controls, and equipment used in these procedures are carefully reviewed during the licensing process to ensure the safety of the public, patients, and occupationally exposed workers.
- 2. Direct and Indirect Effects.
The nuclear medicine field has grown substantially over the past three decades, as evidenced by the increase in license applications, renewals, and 02/08/84 1 Enclosure 3
es
.g
(
\ e amendments. In addition to this numerical growth, the scope of use has expanded dramatically over the years. In order to adequately regulate new developments, many safety measures were added as license amendments or recommended in regula-tory guides, rather than being incorporated in the regulations. However, over the past few years nuclear medicine procedures have stabilized, and uniform and comprehensive safety requirements can now be codified in the regulations in order to establish a more coherent regulatory program.
The current practice of publishing the licensing requirements and guidance in several different sources has resulted in negative impacts on both the licensees and the NRC staff. The applicant is often uncertain about what must be included in a license application. This results in either an application that provides a substantial amount of extraneous information or in one that does not provide enough of the information necessary to make a licensing decision. This requires additional NRC staff time to review large amounts of unnecessary information or to write deficiency letters that request additional information or clarification. In either case, there are frequent delays in the licensing process that lead to a backlog in license applications. The existing regulations also severely limit a licensee's flexibility in selecting the most cost-effective method for complying with NRC requirements since even a minor program change must be approved by a license amendment.
These negative effects of the existing regulatory program have initiated the reevaluation and revision of Part 35.
- 3. Alternative Approaches.
For a detailed analysis of the effects of the proposed revision to Part 35, see the Ve!=/L;9;1 Ct:t:::r' prepared as part of the rulemaking package. 8 ppa /afopy Anolysj3 In developing an earlier staff proposal on the revision of Part 35, SECY-83-62, the staff considered reducing the number of requirements to a few, and simply providing guidance for good practice. Since such a regulatory scheme might not have protected the public health and safety, probably would have left the industry in a state of confusion given the very prescriptive regulatory scheme used for the past several years, and might have made enforcement actions more difficult, the staff did not consider this to be a reasonable alternative.
02/08/84 2 Enclosure 3
F D 4 .
The staff finally proposed in SECY-83-62 that, since the safety requirements had been codified, applicants simply be allowed to certify that they had met the training and experience standards and would comply with the regulations. In its response to SECY-83-62 (Enclosure 2), the Commission directed the staff to continue pre-licensing review of physician qualifica-tions and operating procedures. The SECY-83-62 alternative is therefore no longer reasonable.
The staff also considered that, since the safety requirements had been codified, applicants be required to submit evidence of training and experience and a radiation safety plan that described the licensee's general radiation safety policy and critical safety elements that would be incorporated in site-specific procedures. The staff decided that this alternative was inconsistent with Commission instructions.
The alternative selected by the staff to regulate the human use of byproduct material, the alternative directed by the Commission, includes codification of all generic requirements and staff pre-licensing review of training and experience and procedures.
- 4. Public Comment.
One important reason for revising Part 35 is to allow public comment on requirements before they are imposed in final form. The existing system of imposing requirements through license conditions does not allow for public comment. Incorporating generic license conditions into the regulations will allow public comment on these requirements before they are finalized. In addition, a few representative licensees, some nuclear medicine professional associations, and Agreement State government personnel were contacted on the development of the proposed rule.
- 5. The Regulation Is Written in an Understandable Manner.
The revision of Part 35 has, in part, been prompted by the lack of clarity in the existing rule. The proposed revision is designed to be clear, coherent, and taderstandable.
02/08/84 3 Enclosure 3
, .J
- 6. Reporting Burdens.
- Although the current reporting and recordkeeping activities, and the burdens associated with these requirements, have been cleared by the OMB under the Paperwork Reduction Act, the proposed revision will modify many of the existing requirements. For specific information on the information collection activities of the proposed revision, see the OMB supporting statement in the rulemaking package.
- 7. Name, Address, and Telephone Number of a Knowledgeable Agency Official.
This information will be included as part of the Federal Register Notice that publishes the proposed rule.
- 8. Plan for Evaluation.
Implementation of the revised licensing system under Part 35 will be continuously monitored to determine whether the regulatory objectives are achieved. The proposed revision is itself the result of an evaluation of the existing rule. The staff does not foresee need for another evaluation before the one required as part of the Regulations Coordinating Committee schedule of priorities for review.
f l-02/08/84 4 Enclosure 3 l
l l
l 1
REGULATORY ANALYSIS FOR THE PROPOSED REVIS0N OF PART 35 1
This regulatory analysis was prepared following instructions to Office Directors from the Executive Director for Operations, circulated December 13, 1982. Under those instructions, Part II.A, this proposed rulemaking is not subject to a mandatory regulatory analysis review. However, in the footnote on page 1 of the guidelines, the EDO directed that "... other rulemaking I actions not covered by the mandatory review categories ... should also be supported by an analysis based on the guidance provided in Part III.B of the Guidelines but much less detail is required."
f
- 1. STATEMENT OF PROBLEM This proposed rulemaking affects all persons who are licensed by the NRC to irradiate individuals with byproduct material, or its radiation, in the practice of the healing arts. This industry is currently subject to all the general radiation safety materials regulations (Parts 19, 20, 21, and 30),
Part 35, " Human Uses of Byproduct Material," licensing branch policies, a few generic orders, and many generic license conditions.
The problem with this regulatory scheme is three-fold: 1. All the regula-tory criteria are not published in a single unified text, therefore the applicant or licensee must look in several places to find all the standards that apply to his program; 2. Licensing branch policy and a listing of the applicable 1 generic IIcense conditions are not generally available to the public, therefore the applicant cannot accurately plan for resources needed to meet regulatory burdens until the license is in hand; and 3. Since the requirements are scattered, in order to assure the public health and safety the staff requires that applicants submit for review many detailed procedures that will be followed when the license is issued. Then, they are required by license condition to conduct their programs in accord with the statements made in the application.
7
~
02/01/84 1 Enclosure 4
This proposed rulemaking may be taken at this time because the staff does not believe that dramatic new types of use that would require generic license conditions will evolve in the next decade; rather, the staff believes research will be devoted to refinement of current methods and development of new materials for which the radiation safety measures are similar to the safety measures for materials currently authorized for use. Even if we do see new technologies that have to be handled on a case-by-case basis, that portion of any licensee's program designed to 9rovide conventional patient care will benefit from the clarification and codification of regulations.
If no action is taken, the staff believes the industry will continue to be confused about whether a specific standard is a requirement or a suggestion.
The codification of all regulations in a single document may result in fewer enforcement actions because all requirements will be in one text and all licensees will be working und.er the same set of requirements.
- 2. OBJECTIVES The purpose of this proposed rulemaking is to codify, in plain English, all radiation safety requirements specific to the human use of byproduct material. The staff and the industry generally agree that the requirements in the proposed rulemaking are needed to protect the public health and safety.
- 3. ALTERNATIVES In developing an earlier staff proposal on the revision of Part 35, SECY-83-62, the staff considered reducing the number of requirenients to a few, and simply providing guidance for good practice. Since such a regulatory scheme might not have protected the public health and safety, probably would have left the industry in a state of confusion given the very prescriptive regulatory scheme used for the past several years, and might have made enforcement actions more difficult, the staff did not consider this to be a reasonable alternative.
The staff finally proposed in SECY-83-62 that, since the safety require-ments had been codified, app' : ants simply be allowed to certify that they had met the training and experience standards and would comply with the regulations.
02/01/84 2 Enclosure 4
g - .
In its response to SECY-83-62 (Enclosure 2), the Commission directed the f.taff to continue pre-licensing review of physician qualifications and operatin.J procecures. The SECY-83-62 alternative is therefore no longer reaisonable.
The staff also considered that, sin:e the safety requirements had been codified, applicants be required to submit evidence of training and experience and a radiation safety plan that described the licensee's general radiat on safety policy and critical safety elements that would be incorporated in site-specific procedures. The staff decided that this alterncY.ive was 11 con-sistant with Commission instructions.
The alternative selected by the staff to regulate the human use of f byproduct material, the alternative directed by the Commission, includes codification of all generic requirements and staff pre-licensing review:Iof training and experience and procedures. ,
- 4. CONSEQUENCES ;
I Some general comments on the consequences of the proposed action a,re i
made below. Since the Commission has selected an alternative, the costs and I
benefits of the other alternatives have not been analyzed. A detailed burden I
analysis (expressed in dollars and man-hours) for the directed 2.lternative follows the narrative portion of this regulatory analysis.
- n Igeneral, the staff does not believe there will be any significhnt i
increase in or relief from regulatory burden on licensees, NRC, or Acrrement 1
(States. NRC would have to redirect its training effort because it currently emphasizes review of applicants' procedures at the NRC office rather than an on-site review of work methods at the licensees' facilities. However, the long-term benefit may be a more safety-oriented inspection based on a f unifor'n, lationwide code of standards. l
[ AGREEMENT STATES: PLEASE PROVIDE A PARAGRAPH DESCRIBING TH3 C014 SEQUENCES OF THE PROPOSED ACTION ON YOUR OPERATIONS.]
)',, 9,, /foy fbN /T/)/b Grninia d u l0 .,'$ ' 47 g, . ,
( -fpf /> w, + , n pss d I" /h n '!',
l ,, , p ,,,
p (, ,fglj, , , ,9) es / /$f O*/ 's l
. 02/01/84
, 3 Enclosure 4 i
m
, 0 The staff does not expect any relief from regulatory burden or additional burden for licensees because the requirements in the regulation. nave, for the
. mast part, been taken frorn requirements imposed by other means. There may be fewer ncncompliance citations because all the generic requirements will be published in one place.
l The staff does not foresee any impact on other NRC programs or require-ments. The staff does not foresee any significant transition problem because, as currently written, each license can stand by itself without reference to the current or proposed Part 35. The staff does not foreses any scheduling, enforceability, policy, institutional, or legal problems.
- 5. DECISION RATIONALE The staff is recomnending the proposed revision because it clarifies requirements and grants some authority to licensees to modify their procedures, facilities, and equipment to meet needs caused by char.ging patient care needs.
The proposed revision is complete and the staff does act foresee any need for wide-ranging revisions, additicns, or deletions for :lt least the next decade.
~
, 6. IMPLEMENTATION Since they are fairly complete and site-specific, the current licenses will stand alone to provide for public health and safety. As licenses come due for renewal, they can be reviewed and issued under the proposed regulatory method. Since the equipment and procedures spsicified in the regulation are similar to those required of current licensees, the staff does not foresee any need for significant expenditures of time or noney for renewal licensees or new applicants. However, the staff has specifically requested public comment on the transition policy described in the preamble to the Notice of Proposed Rulemaking.
l The staff is not aware of any relationship between this part and other existing or proposed requirements that w-:uld affect those requirements or causa a need for a reassessment of other actions, systems, or analyses.
1 j 02/01/84 4 Enclosure 4 l
ggf, /hn/' jf O AWMlM N A 97f 0J r l b y fepg/92%9
- fpp //je /4*sl b/O! /Y ""fl be rans/Ve e/ a 9,, ,, gas,/es, 16s f w p rser o f A'.P n o /p er, 7,, 4 4
,j;,4 by,//sr ne "sev ' h A"! N"r ne in .r q Burden of Proposed Revision of Part 35 Y Fe9 Vl"l/VP stive f)c /G&rf /s/> > P, On the following pages, the cost of complying with each individual section of the proposed regulation is estimated. Then, six hypothetical licensees that are representative of the medical industry are described. For each of the six licensees, the total regulatory burden is estimated by adding the burden due ftoeachsectionwithwhichthelicenseewouldhavetocomply(notallsections apply to all licensees). In most cases these are not new burdens because similar requirements are currently imposed by license condition.
1 Explanation of column descriptors and entries DEFGHIM: Describes which class of licensee must comply; cf Subparts 0 through I in proposed Part 35; M refers to mobile service.
Sec: The subsection where the requirement is stated.
l R/0: R denotes a requirement; O denotes a privilege (with concomitant burdens if the privilege is exercised) contained in proposed Part 35.
1
! Freq: Sy-5 years; a-annually; 6m-each six months; q quarterly; m-monthly; w-weekly (50 weeks per year); d-daily (250 days per year);
2xd-twice daily. Note that some frequencies are specified in the regulation, and some have been assumed (superscripted "a") for purpose of estimating total cost.
Hrs for Records: An estimate of hours spent preparing records, reports, and logs, either by a professional (Pro) or by a technician or secretary (Tec). For recurring actions, this is the time needed to do the action once. Cost of paper, forms, and f
f filing space are insignificant and are not included.
Hrs for Work: An estimate of hours spent doing something, other than records generation, that is required of either a professional (Pro) or a technician or secretary (Tec). For recurring actions, this 02/01/84 5 Enclosure 4
L is the time needed to do the action once. These estimates are based on the experience of staff when previously employed by licensees.
Eqpt & Supplies: An estimate of cost of capital equipment and consumable supplies needed based on catalogue prices from nation wide retailers. Capital equipment is amortized over 5 years.
Contract cost: An estimate of the fee charged for a service by an outside contractor. Based on informal surveys.
$/yr: Dollar cost for compliance each year.
Pro Hrs /yr: Total professional time consumed per year for compliance.
Tec Hrs /yr: Total technical and secretarial hours consumed per year for compliance.
N, RG, LC, or R: N-a new requirement imposed by the proposed Part 35 RG-a recommended procedure, contained in a regulatory guide, that is frequently adopted by applicants LC-a frequently imposed license condition, I&E order, or licensing branch policy R-a current regulation Note: RG, LC, and R imply similar, not identical requirements 02/01/84 6 Enclosure 4
m Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, DEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R (Several footnotes follow the Table)
S35.2 License Required.
OEFGHM R Sy 1901 40 R I R Sy 3001 60 R 535.16 Application for license, amendment, or renewal.
DEFGHM R Sy 2021 10 4 2 R 4021 10 8 2 R I R Sy 535.17 License amendments.
All 0 Sy 2 2 1 401 8 0.4 0.2 R 535.18 Notifications.
3 0.1 0.1 All R Sy 0.5 0.5 N
$35.30 ALARA program.
Inst R a 104 10 RG 5
S35.31 RadjationSafetyOfficer. 96 RG All R m 8
$35.32 Radiation Safety Committee.
Inst R q 26 87 40 8 R S35.37 Records and reports of misadminstrations.
DEHM c R 3y 8 1 1 0.3 0.3 R 535.50 Possession, use, calibration, and check of dose calibrators.
DEFM a R 2000 400 RG DEFM bl R d .02 .02 10 RG l 100 0.4 RG OEFM b2 R a .20 .20 500 DEFM b3 R q* .50 1 1
6 0.4 RG RG l DEFM b4 R Sy 1 S35.53 Measurgmentofradiopharmaceuticaldosages. 150 RG
, DEFM R 15xd .02 .02 S35.59 Requirements for possession of sealed sources and brachytherapy sources, DEFM bcd R 6m 0.5 0.5 1508 30 1 R t
758 15 2 R l G bcd R 6m 1 1 R
- 0. 5 0.5 758 15 1 l HI bcd R 6m 0.5 0.5 4 R l All~ g R qtr 0.5 0.5 4 N
- DEFGM hi R qtr l
S35.60 Syringe shields.
02/01/84 7 Enclosure 4
Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Mrs Mrs N, RG, OEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R 635.61 Vial shields.
DEM R 50011 100 RG S35.62 Syringe labels.
DEM 8012 80 N S35.70 Surveys for contamination and ambient radiation exposure rate.
DEM a R d 0.2 0.4 150 RG DEM b R w 0.1 0.1 10 RG OEM e R w 0.2 0.5 35 RG S35.75 Reigase of patients containing radiopharmaceuticals or permanent implants.13 F M R m 500 6000 LC 635.80 Mobilg nuclear medicine service technical requirements.
M d R 2xd 0.4 100 LC a
e R 2xd 0.2 0.2 100 LC 635.92 Decgy-in-storage.
DEFM 0 m 0. 5 1 18 LC 635.120 Possession of survey instrument.
O R 500 5019 150 RG S35.204 Pegmissiblemolybdenum-99 concentration.
E R d .02 .04 15 R S35.205 Controls of aerosols and gases.
E ab R 200014 400 RG E d R 6m 0.1 0.2 0.6 RG S35.220 Possession of survey instruments.
E lo 500 5019 150 RG E hi 1000 5019 250 RG j S35.310 Sa{etyinstruction. 36
- F R m 0.1 0.5 3.015 7 RG l
635.315 Sa{etyprecautions.
i F a R m 45018 5400 RG a
F c R m 0.2 2 RG a 24 l F e R m 1.0 2.017 12 RG
! S35.320 Possession of survey instruments.
F lo R 500 5019 150 RG F hi R 1000 5019 250 RG I S35.404 Re} ease of patients treated with temporary implants.
G a R m 0.1 0.1 1 1 RG I
02/01/84 8 Enclosure 4
Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, DEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R S35.406 Brgchytherapysourcesinventory.
G a R m* 0.1 1 RG G b R m 0.2 2 RG i S35.410 Sa{etyinstruction.
G R m 0.1 0.5 3.015 7 36 RG 935.415 Sa{etyprecautions.
G a R m 4501s 5400 a
G c R m 0.2 2 RG S35.420 Possession of survey instrument. 4 G R 1000 5019 250 RG S35.520 Agailabilityofsurveyinstrument.
H R q 10018 400 RG S35.610 Sa{etyinstruction.
I R y 0.1 0.5 1.018 1 2 RG S35.615 Doors, interlocks, and warning systems.
I b R 200 40 LC I c R 100 20 LC S35.620 Possession of survey instrument.
I hi R 1000 50 250 RG S35.621 Radiation monitoring device.
I a R 750 150 R I d R d 0.02 0.1 30 R 935.622 Viewing system.
I R 1000 200 LC 635.630 Dosimetry equipment.
I a R 2y 2500 40 700 R 535.632 Full calibration measurements.
I R a 16 16 32 R 635.633 Periodic spot checks.
I a R m 0.5 1 18 R I f R m 0.5 1 18 LC i 635.641 Rad {ationsurveys.forteletherapyfacilities.
I al R Sy 0.5 1 0.3 LC a 4 I a2 R Sy 8 4 4 12 LC 02/01/84 9 Enclosure 4
1 Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, DEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R 535.642 Safgty checks for teletherapy facilities. 0.3 I a R Sy 0.5 1 N S35.645 Five year inspection.
I R Sy 200020 400 LC l
l 02/01/84 10 Enclosure 4
l l
l l
Footnotes 1A fee required by Part 170.
2 Assume one amendment for a new user or use over 5 years.
3 Assume one key individual leaves over 5 years.
4 Preparing the program is part of the application time. This cost assumes six hours to prepare an annual briefing and one hour for the RSO to deliver the briefing to three administrators.
sAssume eight hours once each month to investigate a deviation from good practice. Developing policy and procedures is part of the application time.
Procedure modification is not required and therefore not costed. Helping the Radiation Safety Comtrittee is costed in $35.32.
6 Typing and distributing minutes.
7 Assume RSO needs three hours to prepare agenda, and five individuals attend a one hour meeting.
sAssuming 15 procedures per day, 250 days per year, and a frequency of 0.01% (see SECY-82-388 p 2), there will be about one misadministration every three years.
9 Radioactive check sources to convert wipe sample cpm to microcuries.
toAssume two at $150.
4 gg g?
11 Assume five at $100.
12 Assume 4000 labels per year at $10 per 500.
130iagnostic dosages do not require patient confinement for radiation safety purposes. Assume one radiopharmaceutical therapy procedure each month with one additional day of confinement (beyond that needed for patient care) in a private room at $500 each day. Permanent implant administra-tions generally do not require patient confinement for radiation safety purposes.
14 Cost of a closed, shielded gas collection system.
1sAssume RSO briefs six nurses for one-half hour.
16 Assume three days in a private room at $500 instead of a semi private room at $350.
17 Assumed time needed to decontaminate room.
18 Assume the RSO briefs two technicians each year.
02/01/84 11 Enclosure 4
Footnotes (Continued) 19 Calibration service.
20 Assume two days at $750 each day, plus $500 total per diem and travel.
21 Draft Regulatory Guide 10.8 for all applications except teletherapy, and a draft Regulatory Guide that is being developed for teletherapy, are avail-able for use by applicants. Except for site-specific information that must be submitted, applicants can certify that they will follow the model proce-dures in the guides, or mark-up the model procedures to meet their site specific needs and submit clean mark-ups for staff review. This burden estimate assumes that most applicants will use most of the model procedures.
02/01/84 12 Enclosure 4
c Sections'not costed 35.1 Purpose and scope.
35.8 Reporting, recordkeeping, and application requirements: OMB approval.
35.15 Definitions.
35.28 License issuance.
35.29 Specific exemptions.
35.31 Radiation Safety Officer. Having an RSO is required by the general criteria of $30.33 which require that the applicant be qualified by training and experience. Development of procedures is costed @ $35.16.
35.33 Requirement for authority and statement of responsibilities. This is part of the management responsibility to provide a position descrip-tion for any worker.
35.34 Provisional authorized user. This is an option, not a requirement.
The review process may be conducted during the meetings costed at 635.32.
35.35 Mobile nuclear medicine service administration requirements.
35.37abde Records and reports of misadministrations. Therapy misadministrations are very rare (see SECY-83-388 p 2). Investi-gating and making a record of a misadministration is costed @
$35.31 as part of a deviation from good practice.
35.38 Supervision. This is part of the management responsibility to supervise employees.
35.49 Suppliers.
35.50cde Dose calibrators do not break down frequently. Records are costed within the prescriptive requirements to test or check the calibrator.
.35.51 Calibration and check of survey instruments. The calibration cost is included as a contract cost in the section that requires possession of the instrument. The survey instrument check (d of this section) is included in the time needed to make a survey.
35.58 Authorization for calib' ration and reference sources.
35.59e Leaking sources are very rare.
35.63 Vial labels. Vial shields can be permanently labeled in a few minutes.
35.90 Storage of volatiles and gases. A plastic bag within a plastic bag will meet the requirement of the regulation.
02/01/84 13 Enclosure 4
o 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies.
1 4- 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.
35.205c Control of aerosols and gases. Negative pressure in imaging rooms can be achieved by closing the door, turning off or covering supply vents, and fully opening exhaust vents.
35.300 Use of radiopharmaceuticals for therapy.
4 35.400 Use of sources for brachytherapy.
! 35.500 Use of sealed sources for diagnosis.
35.600 Use of a sealed source in a teletherapy unit.
35.605 Maintenahce and repair restrictions.
I 35.606 Amendments. None of the changes which require an amendment request.
are frequently made.
35.615a Doors, interlocks, and warning systems. Doors are usually installed for compliance with Part 20.
35.643 Modification of teletherapy unit or room before beginning a treatment program. A modification for safety purposes is not usually necessary.
35.644 Reports of teletherapy surveys, checks, tests, and measurements.
The licensee need only submit a copy of a record which was costed
! in another section.
The following sections were not costed because they are industry-specific training and experience standards generally required by 630.33(a)(3).
35.900 Radiation Safety Officer.
35.901 Radiation Safety Officer training exception.
35.910 Training for uptake, dilution, and excrettun studies.
35.920 Training for imaging and localization studies.
f 35.930 Training for therapeutic use of radiopharmaceuticals.
35.940 Training for therapeutic use of brachytherapy sources.
35.9e 6 Training for ophthalmic use of strontium-90.
35.95J Training for use of sealed sources for diagnosis.
02/01/84 14 Enclosure 4
t 35.960 Training for teletherapy.
35.961 Training for qualified teletherapy calibration expert.
35.970 Experienced authorized user training exception.
35.971 New physician training exception.
35.990 Violations.
i 02/01/84 15 Enclosure 4
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ffffNah 4 h lbe &////W WW N C C */hl5 f)/f HYPOTHETICAL LICENSEES lY/! 0l l/Ye/Jfe c (~dWW fr,9ee/ h <W /? o Case Description and Regulatory Burden per year (see following tally sheets)
- 1. A nuclear medicine diagnostic clinic that is not based in a hospital, and conducts 15 procedures each day. Annual regulatory burden: $1618, 110 professional hours, and 398 technician hours.
- 2. A nuclear medicine diagnostic clinic that is based in a hospital and conducts 15 procedures each day. Annual regulatory burden:
$1618, 160 professional hours, and 406 technician hours.
- 3. A hospital with a nuclear medicine clinic that conducts 15 diagnostic procedures each day and one radiopharmaceutical therapy procedure each month. Annual regulatory burden: $13,018, 179 professional hours, and 466 technician hours.
- 4. A hospital with a nuclear medicine clinic that conducts 15 diagnostic procedures each day and one brachytherapy procedure each month.
Annual regulatory burden: $7033, 177 professional hours, and 448 technician hours.
- 5. A hospital with a nuclear :::adicine clinic that conducts 15 diagnostic procedures each day and has one cobalt-60 teletherapy unit. Annual regulatory burden: $3211, 233 professional hours, and 463 technician i
hours.
- 6. A mobile nuclear medicine service that conducts about 5 procedures each day at each of two client locations. Annual regulatory burden:
$1618, 110 professional hours, and 598 technician hours.
16 Enclosure 4 02/01/84
^
L CASES
< 1 2 3 4 5 6 Pro Tec Pro Tec Pro Tec Pro Tec Pro Tec Pro Tech S:ction $ hrs hrs $ hrs hrs $ hrs hrs $ hrs hrs $ brs hrs $ hrs hrs 35.2 40 40 60 40 35.16 4 2 4 2 8 2 4 2 35.17 8 0.4 0.2 8 0.4 0.2 8 0.4 0.2 8 0.4 0.2 35.18 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 35.30 10 35.31 96 96 96 35.32 40 8 35.37 0.3 0.3 0.3 0.3 0.3 0.3 35.50 500 16.8 500 16.8 500 16.8 35.53 150 150 150 35.59bcd 30 1 30 1 15 1 15 1 30 1 35.59g 4 4 4 4 35.59hi 4 4 4 4
! 60 35.60 60 60 35.61 100 100 100 35.62 80 80 80 35.70 195 195 195 35.75 6000 35.80 200 35.92 18 18 18 35.120* 150 150 150 35.204 15 15 15
, 35.205 400 0.6 400 0.6 400 0.6 35.220* 250 250 250 35.310 7 36 35.315 5400 12 24 35.404 1 1
.35.406 .
3 35.410 7 36 35.415 5400 2 35.610 1 2 35.615 60 35.621 150 30 35.622 200 35.630 700 35.632 32 35.633 18 18 35.641 12.3 4 35.642 0.3 35.645 400 "This expenditure also meets requirements of $$ 35.320, 35.420, 35.520, and 35.620.
02/01/84 17 Enclosure 4
L CASES (Continued) 1 2 3 4 5 6
$ 1618 1618 11400 5415 1593 1618 subtotal P-hrs 110 160 19 17 73 110 T-hrs 398 406 60 42 57 598
$ 1618 1618 1618 carryover P-hrs 160 160 160 T-brs 406 406 406
$ 1618 1618 13018 7033 3211 1618
-TOTAL P-hrs 110 160 179 177 233 110 T-brs 398 406 466 448 463 598 02/01/84 18 Enclosure 4 l
a ,
- DRAFT ENVIRONMENTAL ASSESSMENT FOR THE PROPOSED REVISION OF 10 CFR PART 35, " HUMAN USE OF BYPRODUCT MATERIAL;" FINDING OF NO SIGNIFICANT IMPACT.
- 1. Introduction The Nuclear Regulatory Commission (NRC) is proposing to revise its regulations that govern the use of byproduct material for patient diagnosis and therapy. Most of the revision would consist of a clarification and consoli-dation of requirements that are part of the application review process or that are currently imposed on licensees as license conditions or inspection and enforcement orders. The revision would also change the method of applying for a " human use" license.
Since some of the regulations may have a physical effect on the human environment, the staff has prepared the following Environmental Assessment.
- 2. Need for the Revision; Rejection of the No Action Alternative-Guidance in the safe use of byproduct material in patient care is currently scattered among the regulations, orders, license conditions, guides, and technical reports. A document that consolidates the critical elements in the guidance is needed to ensure that each individual who needs the information will receive all the information. The document could be a NUREG Report, a Regulatory Guide, or a revision of the regulations. The NRC chose a revision of the regulations in order to reduce the time needed to issue a license and to ensure uniformity of requirements throughout the NRC-licensed medical industry.
hI f ybf There are currently about 2600 " human use" licensees. Each year, the NRC l,
receives about 75 new applications, 250 renewal applications, and 1300 amendment
(/ requests. In order to ensure that the applicant has made a commitment to use I
byproduct material safely, the staff thoroughly reviews each procedure that an 02/08/84 1 Enclosure 7
applicant proposes to use. Since some of the safety criteria that the NRC considers critical are not in the regulations, the application and license are the primary documents used to establish the licensee's responsibility for the safe use of byproduct material. In order to simplify the licensing process without compromising the safety of workers and the public, the Commission believes it is necessary to have the critical safety prescriptive and perfor-mance criteria in the regulations. (Publication of a NUREG report or a Regulatory Guide would provide a consolidated document, but neither has regulatory force. )
Therefore, the Commission has determined that, in order to make the licensing process more efficient and to reduce the amount of time needed to issue a license, amendment, or renewal, the regulations must be revised.
- 3. The Proposed Action and Its Impact
- a. Specific Sections. Most of the proposed revision deals with the safe use of byproduct material in the workplace. The following sections deal with exposure of the public and the environment. .
S 35.75 Release of patients containing radiopharmaceuticals or permanent implants. This section requires that the licensee not release a patient until the exposure rate from the patient is less than 6 milliroentgens per hour at a distance of one meter. The Commission notes that a study of the radiation exposure of family members of patients who were administered 8 to 150 milli-curies of I-131 indicated that the median exposure to a family member living with the patient was 19 milliroentgens (AJPHv68n3 Mar 78pp225-230). Currently, according to a frequently used license condition, the licensee may release a (For I-131, patient who contains less than 30 millicuries of radioactivity.
the most hazardous frequently used radiopharmaceutical, this amount of activity would create an exposure rate of about 6 milliroentgens per hour at a distance of one meter from the patient.) The Commission notes that the International Commission on Radiological Protection has, for many years, recommended limits on radiation exposu of incividuals. "The dose equivalent limits . . .
recommended by the [1%,,. . have been in effect for over 20 years. They have 2 Enclosure 7 02/08/84
3 been widely used internationally and have been incorporated into legislation in a number of countries and regions. Furthermore, there is no evidence to indicate that the [ICRP's] recommended system of dose limitation has failed to provide an adequate level of safety . . . The [ICRP's] recommended whole body dose equivalent of 5 mSv (0.5 rem) in a year, as applied to critical groups, has been found to provide this degree of safety. . ." [ Annals of the ICRP, Pergammon Press, Oxford. ICRP Publication 26, adopted January 17, 1977, paragraphs 77 and 119.] Therefore the Commission has determined that neither the exposure to a family member nor the exposure rate to other individuals or the environment would produce any discernible effect. (See also the discussion of $$ 35.90 and 35.205 that follows.)
S 35.80 Mobile service technical requirements. A mobile service transports and uses byproduct material away from the licensee's base of operation. (The safe transportation of the byproduct material is regulated by the Department of Transportation.) The licensee will be authorized to transport prepared unit dosages, but not multi-dose vials or radionuclide generators. This will ensure that only byproduct material to be used for patient care will be transported. The regulation requires that the licensee ensure, by radiation survey, that all byproduct material, except that administered to the patient, has been removed from the place of use.
Concerning the transportation of by product material, the Commission notes the following information that has been extracted from " Final Environ-mental Statement on the Transportation of Radioactive Material by Air and Other Modes" NUREG-0170 v 1 USNRC Dec. 1977.
"[page iv] Radiation exposure of transport workers and members of the general public along the transportation route occurs from the normal j permissible radiation emitted from packages in transport. More than half of the 9800 person-rem exposure resulting from 1975 shipments was received by transport workers associated with the shipments. The remaining 4200 person-rems was divided among approximately ten percent of the U.S. population. None
- of these exposures would produce short-term fatalities. On a statistical basis, expected values for health effects that may result from this exposure 02/08/84 3 Enclosure 7 l
l are 1.7 genetic effects per year and 1.2 latent cancer fatalities distributed over the 30 years following each year of transporting radioactive material in the United States at 1975 levels (Chapter 4, Section 4.9). More than half of this effect results from the shipment of medical-use radioactive materials where the corresponding benefit is generally accepted (Chapter 1, Table 1-2).
" Transportation accidents involving packages of radioactive material present potential for radiological exposure to transport workers and to members of the general public. The expected values of the annual radiological impact from such potential exposure are very small, estimated to be about one latent cancer fatality and one genetic effect for two hundred years of shipping at 1975 rates (Chapter 5, Section 5.9). More than two-thirds of that impact is attributable to nuclear fuel cycle and other industrial shipments (Chapter 1, Table 1-2). [Only 13% of the impact is attributed to medical shipments.]. . .
" Examination of the consequences of a major accident and assumed subsequent release of radioactive material indicates that the potential consequences are not severe for most shipments of radioactive material (Chapter 5, Section The consequences are limited by one or more parameters: short half-life, 5.6).
nondispersible form, low radiotoxicity. . .
"[page vii] On the basis of the analysis and evaluation set forth in this statement and after weighing the small adverse environmental impact resulting from transportation of radioactive materials and the costs and benefits of the alternatives available for reducing or avoiding the adverse environmental effects, the staff concludes that:
- a. Maximum radiation exposure of individuals from normal transpor-tation is generally within recommended limits for members of the general public (Chapter 3, Section 3.5). There are transportation operations at a few locations where some transport workers receive radiation exposures in excess of the recommended limits established for members of the general public. In most cases, these operations employ radiation safety personnel to establish safe procedures and to train and monitor transport workers as though they were radiation workers.
02/08/84 4 Enclosure 7
a
- b. The average radiation dose to the population at risk from normal transportation is a small fraction of the limits recommended for members of the general public from all sources of radiation other than natural and medical sources (Chapter 3, Section 3.5) and is a small fraction of natural background dose (Chapter 3, Section 3.3). . .
"[Page viii] Based on the above conclusions, the NRC staff has determined that the environmental impacts of normal transportation of radioactive material and the risks attendant to accidents involving radioactive material shipments are sufficiently small to allow continued shipments by all modes."
Currently only about 30 of the Commission's 2600 human use licensees are authorized to transport byproduct material for mobile service. The NRC does not expect any significant increase in mobile service, and therefore does not expect any significant increase in risk due to transportation.
3 635.90Storageofvolatilesandgases,and(35.205Controlofaerosols and gases. These sections allow the storage of volatile radiopharmaceuticals and gases in a fume hood, and the venting of waste material to the atmosphere.
The purpose of these sections is to protect employees from inadvertent release of byproduct material in the workplace. The release of byproduct material to the environment is regulated by Part 20, " Standards for Protection Against Radiation."
The Commission notes that the ICRP has calculated the concentration of a radionuclide in an effluent stream that would cause a member of the population at large to receive an exposure of 0.5 rem in one year. " . . .the [ maximum permissible concentration] values for [the population at large] are one-tenth of the occupational values for. . . the 168 hour0.00194 days <br />0.0467 hours <br />2.777778e-4 weeks <br />6.3924e-5 months <br /> week. " [ Health Physics, v3, June 1960. " Report of Committee II on Permissible Dose for Internal Radiation (1959)", p5] The maximum permissible concentration values in 10 CFR 20 Appendix B for soluble Tc-99m, insoluble TC-99m, insoluble I-131, and Xe-133 are equal to one-tenth of the "168 hour0.00194 days <br />0.0467 hours <br />2.777778e-4 weeks <br />6.3924e-5 months <br /> week" values referred to in the i previous sentence. The appendix B value for soluble I-131 is more restrictive than one-tenth of the "168 hour0.00194 days <br />0.0467 hours <br />2.777778e-4 weeks <br />6.3924e-5 months <br /> week" value. (These are the radionuclides l
02/08/84 5 Enclosure 7
- r most frequently used in human use.) Therefore,. allowing releases up to the concentration values of'10 CFR Part 20 Appendix 8 is not likely to be unsafe to humans.
Concerning radiation exposure of the ecosystem, the Commission notes that a National Academy of Sciences-National Research Council committee stated that
" Evidence to date indicates that probably no other living organisms are very much more radiosensitive than man so that if man as an individual is protected, then other organisms as populations would be most unlikely to suffer harm. In fact, it is very difficult if not impossible to detect any effects of radio-nuclides in the environment even at concentrations much higher than the minimum established by regulation agencies." ["The Effects on Populations of Exposure to Low Levels of Ionizing Radiation," Report of the Advisory Committee on the Biological Effects of Ionizing Radiations, National Academy of Sciences-National Research Council, Washington, D.C. 20006 November 1972, p34.] Since it was determined in the preceding paragraph that man as an individual will be protected,
'we may assume there will not be any detectable effect on other living organisms.
For these reasons, the Commission has determined that, if approved, these sections will not result in any significant impact on the environment.
8 35.92 Decay-in-storage. This section allows the licensee to release decayed byproduct material to the environment. Before doing so, the licensee must survey the material to ensure that the radiation from the material cannot be distinguished from natural background radiation levels. Because there would be no detectable radiation emanating from the released material, there will be no discernible effect on the environment.
S 35.404 Release of patients treated with temporary implants. This section requires that the licensee determine by source count and radiation survey that all implant sources have been removed from the patient. This will ensure that a source and the radiation emanating from it are not unintentionally released to the environment.
02/08/84 6 Enclosure 7
o
$ 35.604 Information to be submitted with application. This section requires that an applicant for a teletherapy license submit information that will allow the staff to make an independent estimate of the environmental exposure due to radiation that penetrates through the teletherapy room walls.
This will help to ensure that the applicant will be able to comply with the requirements of S 20.105, which regulates permissible levels of radiation in unrestricted areas.
The regulations in that section require that the licensee demonstrate that it is unlikely that any individual in an unrestricted area would receive a dose in excess of 0.5 rem in one year. The Commission has determined that this provides an adequate degree of safety for humans (see the discussion of 6 35.75 in this assessment). Occasionally applicants choose to minimize the exposure of individuals by physically restricting access to an area (by a fence, for example) ratner than by providing additional radiation shielding.
In such a case it is conceivable that, although human exposure would be kept below 0.5 rem in one year, some flora and fauna may be exposed to higher levels of radiation.
As noted in the discussion of SS 35.90 and 35.205 in this assessment,
"....it is very difficult if not impossible to detect any effects of radio-nuclides in the environment even at concentrations much higher than the minimum established by regulation agencies." Since it is recognized that, for purposes of radiation protection, there is no inherent difference in the effects of internal as contrasted to external radiation exposure (ICRP Publica-tion 26, paragraph 104), that observation may be expanded to govern this discussion of external radiation exposure.
In these cases the higher levels of radiation proposed by applicants are usually not dramatically higher than the 0.5 rem per year limit, and are usually requested by applicants only when the cost of additional radiation shielding would be an unreasonable expense. The Commission notes that the potential for human benefit due to the availability of radiation therapy far outweighs the conceivable impact on the ecosystem that might be caused by the higher radiation levels. In light of all this the Commission has determined that the benefit to society outweighs any credible impact on the environment.
02/08/84 7 Enclosure 7
D
- b. General. The Commission issues licenses that authorize the intentional irradiation of individuals by licensees. The Commission recognizes that there is a chance that the irradiation of an individual for diagnostic or therapeutic purpose may have deleterious effects. However, in a policy statement that was published February 9,.1979 (44 FR 8242), the Commission gave notice that, while it will regulate the radiation safety of patients where justified by the risk to patients, it will not intrude into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine. For each method of human use authorized by the regulations, the possibility of individual human benefit has been demonstrated by scientific research.
- 4. Summary The Commission has decided that a need exists for a change in the regulations that govern the human use of byproduct material. The change will provide a clear, concise set of regulations for the affected industry. The Commission has determined that there will be no discernible impact on the environment. Therefore, it is not necessary to prepare an environmental impact statement.
l 02/08/84 8 Enclosure 7
l, e
SUMMARY
TABLE OF COMMENTS ON CONTENT OF SECY-83-62 REGULATION OVERVIEW Many individuals recommended that commonly used general safety measures be included in the revision of Part 35 that was contained in SECY-83-62. For example, they would require use of gloves and laboratory coats for individuals handling radiopharmaceuticals, require use of whole body dose monitors for all Part 35 radiation workers and finger dose monitors for individuals who elute generators or handle bracnytherapy sources, specify frequency of radiation worker training, require the use of radionuclide sources for survey instrument calibration, package ordering and opening procedures that are more stringent than required in the current Part 20, requirements that food not be stored along with byproduct material and radioactive solutions not be pipetted by mouth, and specify frequency of air sampling measurements.
The Task Force believes that if such regulations are needed to ensure worker or public protection, an identical case is easily made for placing such requirements on almost all other classes of licensees. Therefore, to assure uniformity and consistency, such requirements would be more properly placed in Parts 19 and 20. The suggested requirements have not been incorporated in the proposed revision of Part 35 because they are not specific to medicine.
Generally, only requirements that are specific to the human use of byproduct material were included in the revision. The few exceptions to this statement are requirements that might apply to some other groups of licensees but are considered critical elements in a medical radiation safety program and whose absence, in light of the specificity of other Part 35 requirements, might be construed as an indication that the requirement was not meant to apply to Part 35 licensees. Examples are performance requirements for survey instru-ments anc contamination surveys.
Many individuals also recommended that more safety measures that are specific to medicine be included in the revision. Some examples that were submitted are: 1. recalibration of imaging equipment that was transported in support of mobile service, 2. storing and preparing volatile radiopharmaceuti-cals and gases in a fume hood, 3. testing frequency for radioactive gas 02/09/84 1 Enclosure 8
t trapping devices, 4. provision of private room with private toilet for hospitalized radiopharmaceutical and brachytherapy patients, and treating such rooms as restricted areas during therapy, 5. control of contaminated items and associated waste, 6. use of remote handling tools for manipulating brachytherapy sources, and 7. use of electrical or mechanical position limit switches on teletherapy units if the. room shielding is inadequate. Many of these comments have been incorporated.
There were many suggested general and medical-specific requirements that might be good practice but are not necessary to keep worker and public doses as low as reasonably achievable below permissible limits. The goal of the drafting committee was to include only those requirements that are specific to the medical use of byproduct material and for which a clear safety need was defined.
Basis of the Table Source documents that were reviewed to prepare this table are identified below. Most comments were keyed to a section of the SECY-83-62 regulation that is identified as a subheading. (If in parenthesis, a commenter suggested a new section not in SECY-83-62.)
The content of the. suggestion is summarized in the left column, and the source document is identified by number and page. In the right column, a J indicates that the comment was added and the new section number is given (a few sections that were in SECY-83-62 have been renumbered); a 0 indicates that the comment was not incorporated and the reason is given.
Since this is a summary table, comments have been dramatically condensed.
Comments that are addressed in the new Statement of Consideration (S of C) are not included in this table. To make a critical review the reader must refer to the source documents. Copies are available from Norman L. McElroy, NMSS, (301) 427-4052.
02/09/84 2 Enclosure 8
Source Documents
- 1. Memo from Vacca and DelMedico (NRC staff) to Chilk dated April 26, 1983.
- 2. Memo from Whatley (Alabama) to Nussbaumer dated May 25, 1983.
- 3. Letter from Shealy (Conference of Radiation Control Program Directors) to Kerr dated October 7, 1982.
02/09/84 3 Enclosure 8
r B 6 35.2 License required Clarify reference to Agreement 0 - defer to ELD.
States - 3p1 6 35.15 Definitions Define podiatrist, dentist - 1 Encl 4 y - added. See 35.15.
Describe responsibilities of auth 0 - ELD recommends responsibilities in user - 1 Enci 4 regulations, not definitions.
Define supervision - 2p10d J - already in SECY-83-62 @ 35.38.
Clarify " visiting authorized 4 - See " provisional authorized user."
user" - 3p1 6 35.16 Application form Clarify the wording - 1 Encl 4 4 - 35.16.
Reflect full regionalization - J - 35.16.
1 Enci 4 t t- X Use an application form that elicits ] - the new form will elicit most infor-more information -1p49 mation that is currently requested.
See 35.16 6 35.17 License amendments Restri>.t " locations of use" (e) V - Section (e) has been restricted, and clarify "other program (f) deleted.
changes" (f) - 3p1 6 35.28 License issuance Licensee may modify procedures V - RSO and management approval required.
without Commission approval - See $ of C.
6 35.30 ALARA program All licensees must have an ALARA 0 - only needed at institutions.
program - 1p51, Enc 1 4 See S of C.
6 35.31 Radiation Safety Committee Clarify ALARA program review - V - 35.30b2.
3p2 6 35.32 Radiation Safety Officer All licensees must identify R50 V - added @ 35.31 1p 54, 1 Enci 4 6 35.33 Authority and Responsibilitie:
Specify annual worker training and 0 - trequency belong's in Part 19, content -1p55a suggested phrases restate Part 19 requirements.
02/09/84 4 Enclosure 8
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6 35.34 Visiting authorized users ;
Only NRC authorized users as 0 - No safety basis, unduly restrictive. '
visiting authorized users -
1 Enci 4 Retain records - 3p2 / - 35.34d S 35.35 Mobile nuclear medi:ine service administration requirements, No generators or kits on mobile 4 - Already in SECY-33-62 @ 35.80i.
service vans -1p56a Mobile services may only have 0 - unnecessary interference with non-licensees as clients -1p56a delivery of patient care. See S of C.
Mobile service must have 1tr of / - already in SECY-83-62 @ 35.35b.
authorization from client management -1p56a 6 35.50 Dose calibrator requirements Have a dose calibrator on nand V - 35.50a.
1p59a Calibration procedure to test 0 - much more prescriptive than ANSI dose calibrator - 1p59a. 3p2 standard N42.13-1978 6 35.51 Survey meter requirements Have a survey meter on hand - 1p60a- V - 35.120, 35.220, . . 35.li20 1p60a Calibrate annually - 1p60a / - already in SECY-83-62 @ 35.51a.
Survey meter calibration procedure / - comment 1 unnecessary, 2-4 1p 60a, 2no10g already in SECY-83-62 @ 3fi Performance standards for survey /-twoofthethreesuggenke.51. d elements meters - 1p60a were already in SECY-83-62, the third allowed contractor servich and ELD says is unnecessary.
Check instruments before and after / - already on SECY-83-62 0 35.51d.
each use - 1p60a Keep a record of the calibration - / - already on SECY-83-62 @ 35.51e.
1p60a (6 35.52) Procedures for ordering, receiving, and opening oackages Don't order more or different than 0 - violation of license authorized - 1p61a Have written procedures for receiving / - 35.31b2ii.
material - 1p61a Train package receivers lp61a 0 - required by Part 19 Have opening procedures - 1p61b 0 - required by Part 20 Critical .iements for opening 0 - noted in Part 20 procedures 1p61b (6 35.52) General rules for safe use Critical safety elements when 0 - applicable to entire nuclear industry, handling material - 1p61c not peculiar to medicine.
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02/09/84 5 Enclosure 8 I
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(6 35.57) In vitro testing per 31.11 Allows general license wi thout 0 grandfather current users, in future, registering - 1p61d request as a line item. See S of C.
6 35.58 Authorization for calibration sources Expand list of sources - 1 Enci 4 4 - 35.58. X S 35.59 Requirements for possession of sealed sources Clarify leak test interval - 1p62 4 - 35.59b2.
Clarify leak test procedure - 2no10h 0 - unduly prescriptive.
Clarify teletherapy leak test J - 35.59c.
procedure - 2no101 6 35.62 Syrinae labels Label syringes with radiopharm 0 - unduly prescriptive.
abbreviation - 1p64 See 35.62.
6 35.70 Surveys for contamination and exposure rate Detect 0.1 mR/hr - 1p64a 4 - 35.70c.
Establish action levels - 1p64a J - 35.70d.
6 35.75 Release of radioactive patients 30 mci for radio pharms and 0 - 30 mci in patient can't be measured.
6 mR/hr @/m for perm. irrplants - 35.75 would allow either. See 5 of C.
1p65a.
More control over patients - 0 - not a significant public health 1 Enci 4 concern.
6 35.80 Mobile service technical requirements Have an on-site physician - 1p65b, 0 - unnecessary hazard is comparable to 1 Enci 4 giving a blood sample or having a stomach x-ray.
Take all material in, remove it all J - already in SECY-83-62.
when you leave - 1p65b See 35.80b Recheck diagnostic equipment at 4 - 35.80d.
each site - 1p65f Remove all material before leaving - J - already on SECY-83-62.
1p65b See 35.80b.
Make close-out survey - 2no10e. 4 - already in SECY-83-62.
See 35.70.
6 35.90 Storage of volatiles and cases Storage in a fume hood or airtight 4 - already in SECY-83-62.
container - 1p66a- See 35.90 Handle therapy iodine dosages 0 - unnecessarily restrictive in a fume hood - 1p66a Check your fume hood biannually - 0 - belongs in Part 20.
1p66a Test trapping devices monthly - 0 - belongs in Part 20. but see 35.205.
1p66a Pre-license review of use areas - J - added to Regulatory Guide 10.8.
2no10f 02/09/84 6 Enclosure 8
o M
Require " operable" fume hood 0 - unduly prescriptive. If its not with minimum face velocity operable, it's not a fume hood.
stated - 2no10m See S of C.
6 35.100 Radiopharmaceucicals for uptake Comply with chemical form - 1p67 0 - see preamble re " word usage." j Specify IND, NDA drugs - 1 Enc 1 4 J - 35.100, 35.200. I RDRC's are for research, not 0 - Added to clarify that, although l patient care, so delete this - not for patient care, such human use 1 Enci 4 is authorized.
Make "any licensee's RDRC," not 4 - 35.100a.
just "the licensee's RDRC." -
1 Enci 4 Loosen restrictions on authorized 4 - 35.100, 35.200.
use - 1 Encl 4 6 35.200 Radiopharmaceuticals for imaging Delete xenon gas 1p68, also 0 - it is a diagnostic radiopharmaceutical RG 10.8 p51 was appended used for imaging. Although it requires some different safety procedures, the level of user training needed and risk to patient are similar.
Comply with chemical form - 1p69 0 preamble re " word usage."
6 35.304 Safety instruction Confine patients to a private room V - 35.315 with toilet - 1p70a Keep the patient's room as a 0 - restricted area is defined in Part 20.
restricted area - 1p70a Control contaminated items - 1p70a 0 - not specific to human use.
Notify RSO of emergencies - 1p70a J - 35.315.
6 35.400 Brachytherapy sources Delete iridium and tantalum as 0 - the drafting committee would like wire lp70a public comment on these.
6 35.405 Safety instruction Add source description to 4 - 35.410.
training - 1p71a Confine patients to a private room J - added private room. See 35.415.
with toilet - 1p71a toilet not needed for safety.
Survey waste for displaced sources - 0 - not needed. but see 35.406.
1p71a Notify RSO of emergencies - 1p71a J - 35.415.
Handle sources with remote tools - 0 - not specific to human use. but 1p71a See 35.400 introductory text.
(6 35.406) Brachytherapy sources inventory Designate a responsible individual - V - already in SECY-83-62.
1p71a See 35.33b 3iii.
Keep an inventory - 1p71a 6 - already in SECY-83-62 see 35.59 g, 35.406 Keep a ledger of source use - 1p71a J - already in SECY-83-62. See 35.404.
But due to the hazard of these sources and the extent of misunderstanding here, suggested elements have been added.
02/09/84 7 Enclosure 8
a 6 35.605 Maintenance and repair restrictions Don't move unit or source - 1p73a J - already in SECY-83-62. See 35.606.
Don't work on the unit - 1p73a J - already in SECY-83-62. See 35.605.
6 35.606 Amendments Delete identical source exchange 4 - deleted. See 35.606 requirement - 1 Encl 4 6 35.610 Emergency instructions Add an element - 1p73 4 - added. See 35.6106i1.
Change title - 1 Enci 4 / - changed. See 35.610.
6 35.620 Doors, interlocks Words are misleading - 1 Enci 4 0 - no one else complained of the wording.
See re-numbered 6 35.615.
6 35.622 Viewing system I t Add aural communication - 0 - No apparent safety need. )(
1 Enci 4 (6 35.623) Electrical and mechanical stops Use mechanical and electrical stops 0 - stops are only one of several ways to ensure compliance with limits to ensure compliance with area dose for unrestricted areas - 1p75a rate limits.
6 35.630 Dosimetry equipment Add "or abnormality" - 1p73 J - 35.630.
Add constancy check - 1 Enci 4 0 - AAPM is revising its recommendation on this topic.
6 35.632 Full calibration measurements Add "or axis distance" - 1p77 0 - the singular is among the plural.
See 35.632bl.
Add " dependence on orientation" - J - 35.632b3.
1p77 Add " manufacturer's name" - Ip77 J - 35.632g.
6 35.633 Spot checks Add " manufacturer's name" - 1p79 V - 35.633j
- Delete " measured time accuracy and 0 - these are important spot-check
- on-off error" - 1p79 items.
(6 35.640) Circumstances requiring special survey
, Events requiring special survey J - added. See 35.641a.
6 35.641 Radiation surveys Survey record elements - 1980b J - most were already in SECY-83-62.
The other have been added.
Define scatter phantom - 2no100 0 - unnecessarily detailed.
02/09/84 8 Enclosure 8 i
o 6 35.644 Survey reports Extended inspection interval V - 35.645d.
authorized - 1p82a 6 35.910 Training for uptake . ..
Training within last five years - V - 35.910a3.
1p83 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> seems too stringent; / - The training requirement has been no clinical experience reduced to parallel training require-required - 1 Enci 4 ments for similar amounts of material.
See 35.910 (cf 33.15b).
6 35.920 Training for imaging . ..
Training within last five years - V - 35.920a3.
1p84 6 35.930 Training for radiopharmaceutical therapy Delete A0BR - 1p86 4 - deleted. See 35.930a.
6 35.940 Training for brachytherapy Add "3 yr clinical experience" - 1p87 4 - 35.940b.
6 35.941 Training for Sr-90 Add " training at an institution" - V - 35.941b2.
1p88 6 35.950 Training for diagnostic sealed sources No training has oeen specified - V - 35.950.
1 Enc 1 4 6 35.960 Training for teletherapy Add certain certifications - 1p89a 4 - 35.960a.
Revise classroom training - 1p89 4 - 35.960b.
More critical elements for work ] - added one, two were already in, experience - 1p89b two are inapplicable.
More critical elements for clinical / - 35.960b3.
experience - 1p89 Require calibration and spot-check 0 - required, in 35.961, of the more experience - Ino10p appropriate individual.
6 32.72 Pharmaceutical distributors Delete " unit dosage" - 1 Enci 4 4 - deleted. See 32.72a41.
Add group numbers - 1 Enci 4 / - 32.72.
6 32.74 Source or device distributors Add group numbers - 1 Enci 4 V - 32.74.
6 35.961 Training for teletherapy expert Add a certain certification - 1p90 4 - added. See 35.961a4.
Clarify two years' experience - 1p90 J - added. See 35.961b.
Training exemption request - 1p90a 0 - see 35.29.
02/09/84 9 Enclosure 8
l
SUMMARY
OF HUMAN LICENSEE CITATIONS ISSUED IN 1982 This table is a summary, by category, of all the citations issued to human use licensees for violation of (1) NRC regulations, (2) NRC orders, (3) license conditions, or (4) commitments made in the license application.
The raw data was supplied by the Division of Fuel Facilities, Materials and Safeguards, Office of Inspection and Enforcement. It is routinely collected as part of their inspection and enforcement program.
The left-most column is the legal basis for the citation. It might be a violation of: a section of the regulations or clear violation of the license, for example adding authorized users without NRC approval, or using more material than is allowed by the license; an order or conditioned permission mailed to licensees in response to a generic safety problem (LTR);
a violation of a standard license condition (SLC); or a violation of the license condition that requires the licensee to use material in accord with representations made in the application (APPL), that perhaps included a promise that a certain regulatory guide (RG) procedure would be used. The second column shows the legal basis for the citation under the proposed regu-lation. The third column is a short description of the citation topic, and the fourth column notes the number of citations issued to human use licensees in 1982.
Of the 1240 citations issued in 1982, 1197 (96.5%) would continue to be citations under the proposed regulations. Furthermore, due to the completeness of the proposed regulation, there may be a much clearer legal basis for more types of citations tha. tould not be issued in the past.
02/08/84 1 Enclosure 9
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NEW TOPIC NUMBER OLD LICENSE REQUIRED 30.3 30.3 license required 2 30.34c 30.34c use only at location on license 19 35.2 35.2 license required 1 35.14b2 35.200 et al. us'e only material listed in regs 2 35.14c 35.2 unauthorized user 1 35.14d 35.58 use only calibration sources listed in regs 4 RG10.80 35.58 et al. use proper, authorized calibration sources .
10 SLC 35.2, 35.17 license or amendment required 22 35.17 unauthorized RSO 1 APPL SLC 35.100 et al. use only for authorized purposes 1 35.38 unauthorized users 1 APPL POSTINGS 19.11a post regs 12 19.11a 19.11b 19.11b post other documents 7 19.11c 19.11c post NRC Form 5 11 19.11d post conspicuously 6 19.11d TRAIN WORKERS 19.12 train workers 31 19.12 SLC 35.610 practice teletherapy emergency plan 1 WORKER AND PUBLIC DOSE LIMITS 20.101a 20.101a worker dose limits 12 20.102a 20.102a determine prior dose 1 limit airborne concentrations 2 20.103 20.103 20.105b 2 mR/hr and 100 mR/wk 23 20.105b 20.108 make bioassays 17 20.108 20.202 supply personnel monitors 52 20.202 20.207a control dose in unrestricted areas 31 20.207a 20.401a keep worker dose records 14 20.401a report worker overexposures 2 20.405a 20.405a report worker dose summary 3 20.407 20.407 RG10.8L 20.202 supply personnel monitors 1 EQUIPMENT have a survey meter 12 APPL 35.120 et al.
calibrate survey meters 39 RG10.801 35.51 RG10.802 35.50 dose calibrator geometry test 16 dose calibrator accuracy test 28 RG10.802 35.50 35.50 dose calibrator linearity test 128 RG10.802 RG10.802 35.50 dose calibrator constancy check 61 RG10.802 35.50 use proper dose calibrator test sources 1 02/08/84 2 Enclosure 9
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NEW TOPIC NUMBER OLD PACKAGE RECEIPT l 20.205b 20.205b monitor packages 10 30.51a 30.51a keep records of receipt and disposal 10 30.51c3 30.51c3 keep records 5 years 2 RG10.8G 35.31 establish an ordering procedure 2 MATERIALS CONTROL 20.207b 20.207b watch material in unrestricted areas 9 20.402a 20.402a report loss or theft immediately 1 20.402b 20.402b report loss or theft in 30 days 1 20.403b 20.403b report incidents 1 RG10.8M 35.90, 35.205 store and control gases 1 SAFETY MEASURES 20.203 20.203 use signs and labels 16 20.203f 20.203f use labels for containers 3 RG10.8G NC wear gloves (22)
RG10.8G NC monitor hands ( 3)
RG10.8G 35.60 use syringe shields 16 RG10. 8G NC wear lab coats (4)
RG10.8G NC don't eat or drink in lab (14)
DOSAGES TO PATIENTS 35.204 measure Mo-99 concentration 16 35.14b4 35.14b6 35.100, 35.200 follow package insert 14 35.43 35.37 report misadministrations 3 35.53 measure dosages 4 RG10.8G APPL 35.50 use a dose calibrator 5 SURVEYS 20.201a make precautionary surveys 37 20.201a 20.20lb 20.20lb make necessary surveys 151 20.40lb 35.40lb keep survey and monitor records 54 35.14b5iii 35.404 survey implant patients 1 35.25 35.644 survey new teletherapy units 5 RG10.8I 35.70 make daily surveys 80 RG10.8I 35.70 make weekly surveys 11 RG10.8I 35.70 keep survey records 3 WASTE DISPOSAL 20.301 20.301 authorized methods 21 20.302 20.302 get permission for other methods 1 20.303 20.303 sewerage release limits 1 20.305 20.305 don't incinerate 2 20.401c3 keep disposal records 4 20.401c3 RG10.8J 35.92 decay-in-storage method 2 02/08/84 3 Enclosure 9
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OLD NEW TOPIC NUMBER SEALED SOURCES 35.14e 35.59e test for leakage 55 35.14e 35.59c record leakage in "microcuries" 5 35.14f 35.59g inventory . quarterly 8 TELETHERAPY CALIBRATIONS AND CHECKS 35.21a 35.632 calibrate if output is off 5% 2 35.21a 35.632a calibrate after source drawer repair 4 35.21b 35.632d calibration procedure 6 35.22 35.633 make spot checks 4 35.22 35.633 check timer accuracy 2 35.22b 35.633b check field / light coincidence 2 35.22b 35.633b compare measured to calculated output 3 35.25a 35.644 keep calibration records 3 TELETHERAPY EQUIPMENT AND PERSONNEL 35.23a 35.630a have dosimetry equipment 1 35.24 35.961 qualified expert training 6 35.25c 35.961 qualified expert training records 1 LTR 35.615 install radiation monitor in treatment room 3 SLC 35.615 use doors and interlocks 1 TRANSPORTATION 71.5a 71.5a follow 00T regulations 11 ADMINISTRATIVE MATTERS RG10.88 35.32a have a radiation safety committee 15 RG10.80 35.30 review worker doses quarterly 2 RG10.80 35.30 review materials program annually 1 Total citations issued in 1982: 1240 Citations not covered (NC) in proposal: 39 Citations covered in proposal: 1201 4 Enclosure 9 02/08/84
r ,
ENCLOSURE B Draft Staff Recommendations l
l
p DRAFT STAFF RECOMMENDATIONS Based on the staff review, DRPES finds that the proposed rulemaking should continue on the schedule adopted by NMSS.
One item was noted that should be brought to NMSS'_ attention. Section 35.400, Use of Sources for Brachytherapy, of the proposed rule lists iridium-192 as wire in (d) and tantalum-182 as wire in (g). The iridium-192 wire is currently the subject of a petition for rulemaking. We are not aware of any action regarding addition of tantalum-182 to the list. Therefore, it may be necessary to delete these before the NPRM is published.
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. Enc 1 ltr fm Bruce W. Ram.ond concerning proposed revision to Part 35 dealing with thrk envelope ATTN: John Savercool radfoactive materials atSONED TO Ca[
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Respectfully referred to Please update ne on this proposal and let me know what the NRC plans to do with it. Thank you.
Rep. Phil Gramm 1230 Longworth House Bldg. .
k*ashington, D.C. 20515 ATTENTION: John Savercool l 1*ery respectfully,
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April 18, 1984
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The Honorable Phil Gramm D Representative United States Congress United States Capital h'a s h i n g t on , D.C. 20515
Dear Representative Gramm:
Currently there is within the CRCl a proposed revision to ILIEt c;15DEifi n gwiDi3 ifi 6plGXe:En NJU i a 1 sl If this pro-posed regulation is published and adopted by the NRC changes will have a direct and derogatory effect on the operation of not only our company but other similar providers through-out the country. MASI is a mobile medical services company, providing nuclear medicine, ultrasound and C.T. services to small rural hospitals, primarily in the north central Texas area. For the small rural hospital the mobile service is without a doubt the most efficient way to provide needed patient services. W.hEpf5jEs7dfGUs~i34 of PagM5;'ydiiTd: haYe C3]FIEcgIypy.t;omt-only, oiggicseCbut;;thogemf-the,1
- p. csp 14cluhs.e rJAq eiJ oTed M S cE7PTrf"~X5?Bist31as 1 inp1Id a tl'6E*.37iW" (f il em t ytrhG~~.iQT[f]@ Yid-h[ndMid67wit'd:peff5' t hMHFXsiipiil915g 'o' (n
Y f f iGMRC~.t),y~e25fERCCHqMed rm'. thF t#2am).1 Presently nobile services are allowed to transport multi dose and single dose vials of radioactive materials both in agreement and non-agreement states. The proposed change would be to allow only transportation and transfer of single, assigned unit doses. The problem with this change is that these unit doses would have to be ordered from a nuclear pharmacy or compounded by the technician before leaving the base hospital. Since they are assigned, no additional patients would be abic to be done once we arrive at a hospital. h'e would be forced to tell the physician "I'm sorry, we cannot do this patient today, he will have to wait until tomorrow". This is neither quality medical care .
nor cost efficient, nor in my opinion, from a radiation safety standpoint, is it necessary. The impact on our business if we
, are unable to do additional patients during the day from a
- a bid-i Pep re}sen t a tiveThe } onorable Ph' l Gramm April 18, 1984 Page 2 ,
I financial standpoint is obvious. The impact on the hospitals is one that is equally as serious. Since the passage of TEFRA have become major points in the provision of healt'h This care.an proposed rule would have the effect of increasing the length of-stay for an inpatient in.a hospital because we were not allowed to carry an extra dose to perform the examination.
The reason that this regulation would have such a large effect in the rural areas on the average approximately 60-75% ofon th patients 85%. are medi~ care and in some places this is as high as inpatientObviously an extension in the length of stay for an could be financially devastating to a small hospital.
Another potential effect this would have on the provision of health as care isinthe necessary theinability ficid. to perform emergency procedures, In most rural locations the nearest is not nuclear pharmacy is an hour to two hours away. This care.
it was your relative or my relative thatvery conducive to providing If prompt pat care, I would certainly be more than a bit upset was in need of this to wait if I had to the next day or for the technician to drive two hours one way and two hours back before he could perform the examination.
I feel'that the present licensing system is more than adequate to address the radiological safety aspects of the provision of mobile nuclear medicine. There may be some cases of abuse of the system, control however, we should not punish the majority to the minority. We also need a consistent If through TEFRA we are to control costs, we certainly cannotfederal policy.-
do this if another governmental agency is placing restrictions upon the health care industry that would increase costs. We would appreciate whatever help you may be able to lend in this matter.
Sinperely, NE CAL ANC LLAR SERVICES, INC,
- N B uo W. bd31496{I/
President Hammo.d)j
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B E RNS T
- HALARO FILE The Honorable Lloyd Bentsen United States Senator 912 Federal Building Austin, TX 78701
Dear Senator Bentsen:
i Thank you for your letter to Mr. Kamerer dated May 18, 1984, on behalf of your constituent, Mr. Bruce H. Hamond, president, Medical Ancillary Services, Inc. Mr. Hamond expressed some concerns about an early draft revision of our regulations governing the medical use of radioactive materials as it pertains to mobile nuclear medicine service companies.
The Nuclear Regulatory Comission staff is currently redrafting the proposed revision of the medical regulations for the Comissioners' consideration. The staff will take Mr. Hamond's coments under consideration when revising the mobile services sections.
The staff plans to forwar'd the proposed revision to the Comissioners late this sumer. If the Comissioners approve the proposed revision, it will be published in the Federal _ Register for public coment.
Thank you for your interest in this matter. If we can provide further infomation, please do not hesitate to contact us.
Sincerely, Ibed) T. A, Rehm DISTRIBUTION - EDO 14443 y# William J. Dircks E cu Di ent al File 0 14443 RMinogue per tb rector for EDO r/f ABentley WKerr BClausser GCunningham JGDavis LUnderwood DMausshardt NMSS r/f RECunningham 6 39 equ VLMiller T NLMcElroy WJDircks A
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l j WASHINGTON, D. C. 20556 I g,...../ OCT 4 E84 MEMORANDUM FOR: William J. Dircks Executive Director for Operations
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FROM: Robert B. Minogue, Director /@'(
j Office of Nuclear Regulatory Research
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SUBJECT:
CONTROL OF NRC RULEMAKING: RES INDEPENDENT REVIEW 0FONGOINGRULEMAKINGSPONSOREDBYADMi f V' b Based on our independent review of the rulemaking, "Comunications Procedures #
Amendments (10 CFR Part 50)," sponsored by ADM, RES agrees with the recomenda-tion of the Director, ADM that this rulemaking effort should continue.
l The basis for our recomendation is as follows:
i
! Many of the sections in 10 CFR Part 50 concerned with application and reporting requirements are silent with respect to the numbers of copies of written commu-
- nications that licensees and pemit holders should submit to the Comission.
The NRC staff has been trying to address the problem of vague and confusing i communication procedures over the course of many years by issuing Regulatory Guide 10.1, " Compilation of Reporting Requirements for Persons Subject to NRC
- Regulations," and NRR Generic Letter 82-14, " Submittal of Documents to the Nuclear Regulatory Commission." These are guidance documents that do not i
resolve the issue of specifying the numbers of copies of reports that licensees and pemit holders must submit to specific addressees in the Comission.
The alternative of incorporating report submittal procedures into technical specifications has been suggested, but this would affect only holders of operating licenses and would not affect applicants and holders of construction pemits.
In view of these factors and the overall independent review of written commu-nications procedures, RES concludes that there is no reasonable alternative to proceeding with this specific ongoing rulemaking to streamline the submittal of standardized number of copies of 10 CFR Part 50 written comunications by applicants and licensees to an established central NRC receipt point, the Docu-ment Control Desk.
ThecompleteRESindependentreviewpackagehasbeensenttoOEDO(Attention:
DEDROGR) and to the Director ADM. This package includes some suggested wording changes in the rulemaking package which we believe will improve the quality of the supporting documentation for the proposal.
Y.
Robert B. Minogue. Director Office of Nuclear Regulatory Research .
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(( / OCT 4 1984 MEMORANDUM F0E: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES INDEPENDENT REVIEW 0F ONGOING RULEMAKING SPONSORED BY ADM Based on our independent review of the rulemaking, " Communications Procedures Amendments (10 CFR Part 50)," sponsored by ADM, RES agrees with the recommenda-tion of the Director, ADM that this rulemaking effort should continue.
The basis for our recommendation is as follows:
Many of the sections in 10 CFR Part 50 concerned with application and reporting requirements are silent with respect to the numbers of copies of written commu-nications that licensees and permit holders should submit to the Commission.
The NRC staff has been trying to address the problem of vague and confusing communication procedures over the course of many years by issuing Regulatory Guide 10.1, " Compilation of Reporting Requirements for Persons Subject to NRC '
Regulations," and NRR Generic Letter 82-14, " Submittal of Documents to the Nuclear Regulatory Commission." These are guidance documents that do not resolve the issue of specifying the numbers of copies of reports that licensees and pennit holders must submit to specific addressees in the Commission.
The alternative of incorporating report submittal procedures into technical specifications has been suggested, but this would affect only holders of operating licenses and would not affect applicants and holders of construction permits.
In view of these factors and the overall independent review of written commu-nications procedures, RES concludes that there is no reasonable alternative to proceeding with this specific ongoing rulemaking to streamline the submittal of standardized number of copies of 10 CFR Part 50 written communications by applicants and licensees to an established central NRC receipt point, the Docu-ment Control Desk.
The complete RES independent review package has been sent to OED0 (Attention:
DEDROGR) and to the Director, ADM. This package includes some suggested wording changes in the rulemaking package which we believe will improve the quality of the supporting documentation for the proposal.
fht k.
Robert B. Minogue, Director Office of Nuclear Regulatory Research
RES INDEPENDENT REVIEW PACKAGE et % UNITED STATES
- NUCLEAR REGULATORY COMMISSION g-g j WASHINGTON, D. C. 20666
- e l
g,*****/ AUG l 4 1984 MEMORANDUM FOR: Robert B. Minogue, Director Office of Nuclear Regulatory Research FROM: Robert M. Bernero, Chairman RES Independent Review Board l
SUBJECT:
M1h0TES OF RIRB DELIBERATIONS FOR ONGOING l RULEMAKING SPONSORED BY ADM The rulemaking review package received May 24,1984 (Mail Control RES-841193),
states:
"The Office of Administration (ADM) has reviewed the ' Communications Pro-l cedures' proposed rulemaking against the review criteria defined in your ,
February 13, 1984 memorandum Control of NRC Rulemakings by Offices Report-ing to the ED0 and the underlying factors that prompted the initiation of :
this rulemaking and recommends that thc rulemaking process be continued."
l Enclosed is the draft independent review package as prepared by responsible RES l
-staff and considered by the RES Independent Review Board.
l At RIRB meeting No. 1 on July 6, 1984, the RIRB members voted 4 to O to recom-mend that the NRC should proceed with the rulemaking, "Comunications Proce- ,
dures Amendments (10 CFR Part 50), sponsored by ADM, subject to the following i conditions:
( o Correct regulatory drafting errors in the draft Federal Register no-tice of proposed rulemaking.
o Resolve question of whether this proposed rule amends information collection requirements in 10 CFR Part 50.
o Clarify that amending communications procedures will not alter NRC's l
regionalization policy, particularly with respect to the Fort St.
Vrain Nuclear Generating Station.
! o Identify forward comitment of NRC resources whenever written commu-nication requirements in 10 CFR Part 50 are added, rescinded, or amended.
o Resolve concerns that the proposed rule, as presently structured, may not reduce overall, the number of copies of reports submitted to the
! Commission.
i l
l l
Robert B. Minogua The bases for the conditions are as follows:
o Regulatory drafting errors. The Agency Contact should cause a com-prehensive review of the draft Federal Register notice to eliminate numerous regulatory drafting errors. For example, page 2 of the Federal Register notice cites 550.30(c)(1)(1) which would be removed by amendatory language on page 12; page 4 uses the words of issuance for a final rule rather than a proposed rule; proposed 650.4(b)(3) cross-references 550.30(c)(3) which would be removed by amendatory language on page 12; and the proposed revision of Appendix E, section V, uses the version before it was revised December 1982.
o Paperwork reduction. The preamble in the Federal Register notice states that this proposed rule amends information collection require-ments. ADM staff members, however, are not certain whether the proposed rule does this. It might reduce burden and dollar costs ancillary, but not chargeable to, the reporting and application re-quirements in 10 CFR Part 50. If this is true (based on a forth-coming response from OMB), the Agency Contact will have to replace the Paperwork Reduction Act statement with one indicating that OMB clearance is not required.
o Regionalization. The proposed revision of 10 CFR 50.4 would remove existing 550.4(c)(1) that delegates authority to the Regional Admin-istrator of Region IV authority and responsibility for implementing selected parts of the Commission's nuclear reactor licensing program for the Fort St. Vrain Nuclear Generating Station. The RES indepen-dent reviewer's preliminary judgment is that the proposed rulemaking could avoid raising unnecessary questions by advising interested per-sons that changing the addressee for signed originals of written com-munications will not alter the limited licensing authority for Fort St. Vrain in Region IV as set out in the Comission's Policy State-ment on Regionalization (March 1,1984,49FR7676).
o Relationship to proposed regulations. The proposed rulemaking con-stitutes a forward commitment by the NRC to amend proposed $50.4 whenever a written communication requirement is added or rescinded in 10 CFR Part 50. In addition, each new or amended written comu-nication requirement in 10 CFR Part 50 will have to contain a cross-reference to 650.4. The RES independent reviewer's preliminary judgment is that the forward commitment of NRC resources should be identified for the information of all NRC staff likely to be involved in 10 CFR Part 50 rulemaking, o Claimed reduction in number of copies of reports.
- 1. The abstract notes that the proposed amendments would simplify the procedures for making Part 50 submittals to the NRC and would establish a central NRC receipt point for the Part 50 sub-mittals. The proposed amendments would accomplish the opposite.
In most cases, the licensee would be required to send the
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Rob 2rt B. Minogue connunication to three addressees,'NRC Headquarters, the Regional Office, and the Resident Inspector, whereas the existing pro-visions usually require submittal to two addresses at most.
- 2. One of the major incentives for this rulemaking, as indicated in the abstract and the " Supplementary Infonnation" section of the rulemaking, 'is to require fewer copies of submittals. Using-information available to me, it appears, in a substantial number of submittals, that the number of copies required to be submitted are increased, rather than reduced. Further, the cost data provided in Attachment 1 of the Regulatory Analysis incorrectly indicates that no changes have been made when, in fact, the number of copies have been increased. -Examples where Attachment 1 incorrectly indicates no change are:
- a. Submittals under Appendix G.V.E. now require or.c .eport to NRR by Regulatory Guide 10.1. The proposed rule would require submittals to NRC Headquarters (Document Control),
the Regional Office and the Resident Inspector. Similarly, the existing requirements in the regulation itself or in Regulatory Guide 10.1 now specify less copies than in the proposed rule with regard to reports required by' Appendix H.II.B.3; Appendix H.III.A; and Appendix J.V.B.
- b. The proposed rule requires five copies for the report required by $50.54(p). Regulatory Guide 10.1 now specifies three copies.-
- c. The proposed rule would require thirteen copies of the
' updated FSAR required by 650.71(e). Regulatory Guide 10.1 specifies twelve copies to NRR.
- 3. The proposed revised section 50.4(b)(1)(ii) states that "...any communications from the applicant to the Commission pertaining to an application" re that a total of forty copies (including the original) quires be submitted. This provision should be deleted because it is excessively broad, subject to misinterpre-tation, and conflicts with the provisions in the proposed followingsubparagraphs(2),(4),(5),and(6).
- 4. Proposed subparagraph (b)(2)(xii) of 50.4 includes the reports required by 650.54(a)(2), and $55(f)(2). - Since these reports were required to be submitted by June 10, 1983 it appears unnec-essary to include these reports in the proposed rulemaking.
Also, conforming changes are not proposed in 950.54(a)(2) and 955(f)(2)sothatthesesubparagraphswouldconflictwith950.4.
- 5. Subparagraph (xiv) of proposed paragraph 650.4(b)(2) would require that changes to quality assurance topical report descriptions be submitted to the appropriate Regional Office and the appropriate NRC Resident Inspector, as well as the
. Robert B. Minogue u Headquarter's Document Control desk. During rulemaking on this subject, in response to public comments, the requirement to sub-mit the- topical report to Regional Offices was deleted because of the' burden on the topical report organization of having to detednine which Regional Offices are involved and sending copies to all of the involved Regional Offices. If~it is now decided that these organizations need to make such determinations and send copies to all the involved Regional Offices, the " Supple-mentary Information" section should explain the rationale for this: change. This is another example where Attachment 1 of the Regulatory Analysis incorrectly indicates no change in the copies required to be submitted to NRC.
- 6. SectionII.1.cofAppendixKnowrequiresthat"acompletclisting of each computer program...shall be furnished to the Nuclear Regulatory Commission." I am not aware of the number of such copies currently being furnished. The proposed rulemaking would require that, instead of a listing of each computer program, forty copies, including the original, of the " Computer programs used in emergency core cooling system (ECCS)' evaluation model pursuant to Appendix K.II.1.c" would have to be furnished, including a copy to the Regional Office and to the Resident Inspector. This proposed requirement appears excessive and I question the need for the computer program by the Regional Office and to the Resident Inspector. Thi: pr:p=:d r:;:f rz t *gg
- ppar; =:n;h =d I ; nti= th: xxd fx th: xe tc _
pr:;rr by th: R:;i:=1 ^ "i:: xd th: Esit;; LiaWm . Is it the intent that the computer program tapes be submitted? If not, the provision needs clarification. I also note that Attachment I to the Regulatory Analysis indicates no change in these Appendix h. requirements.
LCz p Robert M. Bernero, Chairman RES Independent Review Board
Enclosure:
Draft independent review package for " Communications Procedures Amendments (10 CFR Part 50)"
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NUCLEAR REGULATORY COMMISslON umTED STATES p
g WASHWGTON. D. C. 20556 g
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JUN 151l184 MEMORANDUM FOR: James C. Malaro, Chief Regulatory Analysis and Materials Risk Branch Division of Risk Analysis and Operations, RES FROM: Robert M. Bernero. Director Division of Risk Analysis and Operations, RES l.
l
SUBJECT:
RES INDEPENDENT REVIEW 0F ONG0ING RULEMAKING l SPONSORED BY ADM In response to the memorandum dated June 15,1984, DRA0 has prepared a draft independent review package for the rulemaking, " Communications Procedures Amendments (10 CFR Part 50)," sponsored by ADM.
The draft staff recommendations are that NRC should proceed with the i specific ongoing rulemaking sub. ject to the following conditions:
l o Correct regulatory drafting errors in the draft Federal Register notice of proposed rulemaking.
l o Resolve question of whether this proposed rule amends
- infonnation collection requirements.
! o Clarify that amending communications procedures will not l alter regionalization policy, o Identify forward consnitment of NRC resources whenever written communication requirements in 10 CFR Part 50 are added, rescinded, or amended.
Please review the draft independent review package for adequacy and
- schedule it-for RIRB deliberations.
C "/
p T R5 e b Berne o, rector I Division of Risk Analysis and Operations
- Office of Nuclear Regulatory Research i
Enclosures:
A. Rulemaking review package received from ADM B. Draft staff recommendations C. Results of RES staff review '
Contact:
J. Henry 443-7614
.i
F ENCLOSURE A RULEMAKING REVIEW PACKAGE RECEIVED FROM ADM i
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f&Y 101534 MEf 0RA!!DUM FOR: Willian Dircks Executive Director for Operations FR0ll: Patricia G. florry, Director Office of Administration SLEJECT: PROPOSED RULB%KI!1G PR0fULGATED BY THE OFFICE OF ADl:IllISTRATI0fl "C0ftUllICATI0liS PROCEDURES" (10 CFR 50.4)
The Office of Administration (ADil) has mytewed the "Cornunications Pmcedures" proposed rulemaking against the review criteria defined in your February 13, 1984 menorandum " Control of flRC Rulemakings by Offices Reporting to the ED0" and the underlying factors that protpted the initiation of this rulemaking and recomentthat the rulemaking process be continued. The data required for your assessment of the need for the rulemaking are enclosed.
The Comunications Procedures rule was initiated as a result of recognized problems in the guidance given to licensees and applicants for submitting doctments to NRC. ADM, in conjtmetion with the Office of Nuclear Reactor Regulation, the Office of Nuclear Material Safety and Safeguards, the Office of Inspection and Enforcement, and the Regional Offices developed this proposed ru1 snaking to clarify and standardize the comunications procedures.
OtB regulation, 5 CFR 1320.6, limits the ntnber of copies that we can require of licensees and applicants to an original and two copies unless ;
the need for more copies can be adequately justified. During the development i of this rulemaking, serious consideration was given to the actual llRC copy requirement needs and adjustments were made accordingly.
Because of the natum of NRC's mission, it is not feasible to reduce all j copy requirenents to three copies. However, this rule will streamline copy requirements for licensee reports to an original and two copies in most cases. To further lessen the burden associated with submittals, this rule will eliminate the re-transmittal of licensee comunications between Regions and Headquarters by establishing the Doctnent Control
- Desk as the receiving point for all 10 CFR 50 submittals, centralize submittal requirements under 50.4, and with minimal exception, standardize '
the nutber of copies to be submitted.
Please contact John Philips on extension 27086 if you require additional information Ortsnal signed by E41193
- M. STEELE CONCURRED FOR W. BESAW Pctr! cia Norry
- CONCURRED BY TELEPHONE Patricia G. Norry. Director , / /7 .
ome, .I.lD.C.*. ... ....I D.C.*. ..T.I.D.C.*...C ffice of Ah ation
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Comunications Procedures Amendments, 10 CFR 50" e
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I Enclosure i
TITLE:
Corrunications Fro:ecuru A er.cments CFR CITATION:
10 CFR 50 ABSTRACT:
This proposed rule would amend the regulations which establish the procedures for submitting correspondence, reports, applications, or other written communications pertaining to the domestic licensing of production and utilization facilities.
The proposed amendments are expected to resolve confusion regarding submittal procedures and improve the communication process with the affected applicants and licensees.
The proposed amendments would:
- Simplify the procedures for making Part 50 submittals to the NRC.
o Facilitate the timely dissemination'of Part 50 submit .ls to NRC staff.
o Reduce postage and copying costs for applicants and licensees by requiring fewer copies of submittals. .
o Establish a central NRC receipt point for Part 50 submittals.
o Include the NRC Resident Inspectors in the formal communication process between NRC and licensees.
o Require that applicants and licensees cite the specific regulation governing the submission of Part 50 canmunications.
o Supercede all outdated submittal directions contained in other sources of submittal guidance, such as Regulatory Guide 10.1 (Revision 4), NRR Generic Letter 82-14, and the technical specifications of operating licenses.
The current regulations of 10 CFR Part 50 are often vague with respect' to the proper procedures for submitting written communications to the NRC. Efforts to resolve the c'onfusion resulted in the i issuance of Regulatory Guide 10.1 Revision 4 and NRR Generic Letter __...
82-14. Although these documents addressed the problem, they did not entirely resclve the confusion. Moreover, subsequent changes in the organizational structure of NRC were not reflected in the guidance documents.
l
Tr.c current regulations also caust unnecesscry delays in the disseminaticr.
of infonnation to NRC staff. For example, any document submitted to an NRC Regional Office will not usually be disseminated to NRC Headquarters staff until two weeks later. These problems can be resolved only by amending 10 CFR Part 50, since the current regulations are the source of the problems.
The proposed rule is expected to reduce postage and copying costs for licensees and applicants subject to 10 CFR Part 50. An annual savings of $140,000 is estimated. In addition, the NRC is expected to realize a small savings in postage costs. Preparing and publishing this rule would cost NRC approximately 320 hours0.0037 days <br />0.0889 hours <br />5.291005e-4 weeks <br />1.2176e-4 months <br /> of staff time at
$60 per hour for a total of $19,200. g d TIMETABLE: dM NPRM 06/ )D/84 LEGAL AUTHORITY:
42 USC 2201 EFFECTS ON SMALL BUSINESS AND OTHER ENTITIES: No AGENCY CONTACT:
Michael D. Collins Office of Administration Washington,'DC20555 ~
301 492-4955 ,
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NUCLEAR REGULATORY C0ftilSSION 10 CFR Part 50 Comunications Procedures Amendments AGENCY: Nuclear Regulatory Comission.
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Comission (NRC) proposes to amend its regulations that establish the procedures for submitting correspondence, reports, applications, or other written communications pertaining to the domestic licensing of production and utilization facilities. The proposed amendments indicate the correct mailing address for delivery of the comunications and 'specify th'e number of copies required to faci ~..: ate action by the NRC. The proposed amendments, if adopted, are expected to resolve a number of problems that have developed during the past several years regarding the submittal of applications and reports. In addition to clarifying the procedures, these amendments will result in a substantial reduction in reproduction and postage costs for the NRC and.affected licensees.
I DATE: Coment period expires . Comments received after this date will be ' considered if it is practical to do so, but assurance of consideration cannot be given except for those comments received on or before this date.
ADDRESSES: Interested persons are invited to submit written coments l and suggestions to the Secretary of the Commission, U.S. Nuclear Regulatory Comission, Washington, DC 205S5~,- Attention: Docketing and Services Branch. ,
l l
TUR FURTHER INFORK;TIO:4 CDiiACT: Michati C cli % , fu m " ' ' .* em Branch, Division of Technical Information and Document centrol, Office of Administration, Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301) 492-8585.
SUPPLEMENTARY INFORMATION: Because of recent revisions to the NRC's requirements for the submittal of information by applicants and licensees, confusion has arisen with regard to copy requirements and proper submittal procedures. In an effort to clarify these matters, the NRC issued Regulatory Guide 10.1 (Rev.ision 4) " Compilation of Reporting Requirements for Persons Subject to NRC Regulations," and on August 8,1982 the Director, Division of Licensing, Office of Nuclear Reactor Regulation, issued Generic Letter 82-14 " Submittal of Documents to the Nuclear Reguletory Commission." While these efforts at clarification resolved much of the confusion, applicants and licensees continue to demonstrate concern and confusion as to specific requirements. Therefore, the NRC is issuing this rule to specify' copy requirements and provide mailing instructions.
This rule supersedes all existing requirements and guidance with respect to the number of copies and mailing procedures. This rule codifies actions to reduce copy requirements. For example, $ 50.30(c)(1)(i) would be amended to reduce copy requirements for amendment applications from W '
60 to 40; copy requireme or licensee reports would be reduced to three. The proposed rule, reduce overall the number of copies transmitted to the Commission. These changes would result in reduced reproduction and postage costs for licensees.
Undesignated par'agraphs in the amended text have been designated and obsolete titles of NRC personnel have been updated to reflect current NRC titles.
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- 2 P This proposed rule ame*nds infont,ation collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
These requirements were approved by the Office of ?!anagement and Budget approval number 3150-0011.
REGULATORY FLEXIBILITY CERTIFICATION STATEMENT Based upon the information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commis'sion hereby certifies that, if promulgated, this rule will not have a significant economic impact upon a substantial number of small entities. The proposed rule would amend 10 CFR 50 by specifying submittal procedures which facilitate NRC processing. The rule is expected to affect nuclear generating facilities by reducing the overall regulatory burden of reproducing and transmitting submittals to the Comission. Therefore, it is not expected to have a significant economic impact on any licensee. However, coments on the expected economic impact of this proposed rule on any small entity are welcome.
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Antitrust, Classified inf ormation, firt pru ention. Incorporation by reference, Intergovernmental relations, Nuclear power plants and reactors, Penalty, Radiation protection, Reactor siting criteria, and Reporting Wodkugy requirements.
( k uu.aA M 4 W h O-Under the authority of the Atomic inergy Act of 1954, as amended, the 1 ,gxAA.
Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, the following amendments to 10 CFR Part 50 are published as a document Ap subject to codification.
The authority citation for this document is: Sec.161 Pub. L.83-703, 68 Stat. 948, as amended (42 U.S.C. 2201), and Sec. 201, Pub. L.93-438,
}
88 Stat.1242 (42 U.S.C. 5841). 4go.
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- l. Section 50.4 is revised to read as follows: U g sA-p.c. s 80.4 Written Communications. '
7 9. . L -
(a) Address Requirements. The signed original of all correspondence, reports, applications, and other written communications from the applicant or licensee to the Nuclear Regulatory Commission concerning the regulations in this part or individual license conditions must be addressed to the U.S. Nuclear Regulatory Commission, ATTN: Document Control D'esk, Washington, DC 20555.
f.c.
(b) Distribution cuirements. Copies of all correspondence, reports, and other written communications concerning the regulations in this part or individual license conditions must be submitted to the Nuclear Regulatory Commission at the locations and in the quantities set forth below (addresses for the NRC Regional Offices are listed in Appendix D of Part 20 of this chapter).
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(1) Permits, Licenses; and Amendments. Each licensee or applicant shall submit any written conmunications, as defined in paragraphs (i) through (xviii) of this section, which are required for an application 4
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- t- c t to : : r.:t ; m *
. '. t a t m ; l i c e n s e , c c ~ , .' esc, as itilec . en t;; a et'.._:.::t specified in tras u;ticr.. tre s . ped original and 37 copies to the Nuclear Regulatory Comission, Document Control Desk, ,
Washington, DC 20555, one copy to the appropriate Regional Office and one copy to the appropriate NRC Resident Inspector, if applicable; (i) Application for exemption pursuant to 550.12 ,f tFis pert; -
(ii) Application (including any applicable drawings, maps, photographs, models, or computer printouts) for an operating license, construction permit or amendment pursuant to 5550.30 through 50.49, and any communications from the applicant to the Commission pertaining to an application; e
(iii) Additional TMI-related requirements pursuant to 550.34(f) .ef thi;-pert; (iv) Request for approval of design feature or specification pursuant to 550.35(b) e4-t.h4-par-t; (v) Analysis to ensure safe plant operation pending completion of equipment qualification pursuant to 550.49(i) ef this pr-t; (vi) Application for amendment of technical specifications pursuant to 550.55a(g)(5)(ii) Of this-part; (vii) Application for exemption pursuant to 550.73(f) e4-thh Peet; (viii) Application for transfer of license pursuant to 550.80(b) et La not; (ix) Application for termination of license pursuaht to 550.82(a) ef this-pert; 5
T
( >. ) Application for atendment of license or construction permit pursuant to 150.90 f tFi; prt, except as provided in paragraph
, (b)( ) of this section relating to safeguards information; 7 (xi) Analysis o'f no significant hazards consideration pursuant to 550.91 f th b p.,;.; ;
(xii) Information concerning the modification of structures, systems or components ofhfacility pursuant to 550.109 Of thi: prt; (xiii) Evaluation of the potential for effects from long-term buildup of radioactive material in the environment pursuant to Appendix I " Concluding Statement of Position of the Regulatory Staff," A.3.a of this part; (xiv) Computer programs used in emergency core cooling system (ECCS) evaluation model pursuant to Appendix K.II.l.c of this part; (xv) Application for a manufacturing license pursuant to Appendix M of this part; (xvi) Application for license to construct and operate nuclear power reactors of the same design pursuant to Appendix N of this part;
( (xvii) Preliminary or final standard design for a nuclear power
- reactor pursuant to Appendix 0 of this part; and l
t 1 (xviii) Application for early site suitability review pursuant to h Appendix Q of this part. ,
(2) Reports and er{ommunications.Written communications, as I
defined in paragraphs (i) through (xxviii) of this section, that are required of holders of operating license or construction permits, must i .
6
t< Lubmitted es foilens: the signed original to the L;it ar -4;ulatery Comission, Document Control Desk, Washington, DC 20E55, one,co;;y to the appropriate Regional Office, and one copy to the appropriate NRC Resident Inspector, if applicable; (i) Periodic report of the progress and results of research and development programs pursuant to 550.35(b) M t;,;. yo,i.;
(ii) Notification of exceeding any safety limit for nuclear reactors pursuant to 550.36(c)(1)(i)(A) # t;,is part; (iii) Notification of exceeding any safety limit for a fuel reprocessing plant pursuant to 550.36(c)(1)(i)(B) M thi5-pert; (iv) Notification of failure of an automatic safety synem to function as required for nuclear reactors pursuant to $50.36(c)(1)(ii)(A)
M this ye,i; (v) Notification of failure of an automatic alarm or protective device to function as required for a fuel reprocessing plant pursuant to 350.36(c)(1)(ii)(B) Of thi; ;;rt; (vi) Notification of failure to meet limiting conditions for operation (Licensee Event Report) pursuant to 550.36(c)(2) r# thi: p;rt; W-(vii) Reports required by approved technical specifications pursuant to 550.36(c)(5) f this pert. These reports include but are not limited to the following: startup reports, periodic operating reports, source leakage- reports, annual environmental reports (Parts A and B), and nonroutine environmental operating reports; (viii) Semiannual effluent release report pursuant to 550.36a (a)(2)
_ bh II I J yet 7
e
(i>) 5 c ta :.u i e f u c. _ , . o - .. i ;
to safety pursuant to ILO.4(s,) ~ - , :a (x) Request for extension of submittal deadline pursuant to 550.49(g) Of this -part; (xi) Notification of a significant problem requiring extension of completion date pursuant to 550.49(h) Of thi: part; (xii) Description of a quality assurance program pursuant to 550.54(a)(2) or 550.55(f)(2) Of this p;M; (xiii) Change to the Safety Analysis Report quality assurance program description pursuant to 550.54(a)(3) or 550.55(f)(3) Of this part; (xiv) Change to an NRC-accepted quality assurance topical report description pursuant to 550.54(a)(3) or 550.55(f)(3) of this pu t; (xv) Statement to enable the Commission to determine whether a license should be modified, suspended, or revoked pursuant to 550.54(f) of thi; pstt; (xvi) Report of levels of insurance or financial protection pursuant to 550.54(w)(4) :f thi; pr.rt; (xvii) Construction deficiency report and interim deficiency report pursuant to 550.55(e)(3) ;f this- part; (xviii) , Notification of impracticality of conforming with code requirements purs'uant to 550.55a(g)(5)(iii) f this-part; a.,.
(xix) Annual report of changes, tests and experiments pursuant to 550.59(b)hfthispert; (xx) Reports required by the Nuclear Regulatory Commission pursuant to 550.71(a) f this part, e.g., responses to Bulletins issued by the Nuclear Regulatory Commission; 8
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t : ." . x ; :. : :
(xxi) ...; finena ci rq .
(xxii) Licensee Event Report (LER) and supplemental infomation
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pursuant to 550.73(c) and (d) cf tF.ia m t; (xxiii) Infomatisn regarding modification of structures, systems, or components of a facility pursuant to 550.109(c) cf tt.i: prt; (xxiv) Infomation regarding reactor vessel beltline material inservice program pursuant to Appendix G.V.E. of this part; (xxv) Proposed withdrawal schedule for urveillance capsules pursuant to Appendix H.II.B.3 of this part; (xxvi) Report of capsule withdrawal and fracture toughness tests pursuant to Appendix H.III.A of this part; w.
(xxvii) Report of release in excess of design objectives pursuant to Appendix I.IV.A.3. of this part; (xxviii) Reactor containment. building integrated leak rate test pursuant to Appendix J.V.B of this part.
.e. )l. . c -
(3) Acceptance Review Application. Written communication required for an _ application for detemination of suitability of docketing pursuant to
' h50:N(c)(h# tM;--part must be submitted as follows: the signed original hA and 13 copies to the Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555,and one copy to the appropriate Regional Office.
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(4) Security Plan and Related Submittals. Written communications, as defined in paragraphs (i) through (iv) of this section, must be submitted as follows: the signed original and three copies to the Nuclear Regulatory Comission, Document Control Desk, Washington, DC 20555, and two copies to the appropriate Regional Office; (i) Physical security plan pursuant to 550.34 ef ttia yori.;
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s
(ii) Laicparcs cer.:ir p ng ;ian pursuar.t to !!:. M ~... g; ;
(iii) Change to security plan or safeguards contingency plan made without prior Commission approval pursuant to 550.54(p) :f thi: prt; (iv) Safeguards information contained in an application for amendment pursuant to $50.90 cf thi: p rt.
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(5) Emergency Plan and Related Submittals. Written communications as defined in paragraphs (i) through (iii) in this section, must be submitted as follows: the signed original to the Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555, two copies to the appropriate Regional Office, and one copy to the appropriate NRC Resident Inspector; (i) Emergency plan pursuant to 550.34 ;f this rect; (ii) Change to an emergency plan pursuant to 550.54(q) of this-pert; (iii) Emergency implementing procedures pursuant to Appendix E.V. of this part. .
(6) Updated FSAR. An updated final safety analysis rsport (FSAR) or replacement pages, pursuant to 550.71(e) e' th-;5 pert must be submitted as. .
follows: the s.igned original and 10 copies to the Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555, one copy to the appropriate Regional Office, and one copy to the appropriate NRC Resident Inspector.
jf.'-
(c) Form of Communications. All copies submitted to meet the requirements set forth in paragraph (b) of this section must be typewritten, printed or ~~
otherwise reproduced in permanent form on unglazed paper. Exceptions to these requirements may be granted for the submittal of 10
r i t r( tm : . ; . tegra; hic, er eletiru k f er : . Frior to nSiing any sukittal in c hcr than paper fom, the applicant or licensee mest contact the Division of Technical Information and Document Control, Nuclear Regulatory Comission, Washington, DC 20555, Telephone (301) 492-8585, to obtain specifications, copy requirements, and prior approval.
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j (d) Delivery of Comunications. Written comunications may be delivered to the Document Control Desk at 7920 Norfolk Avenue, Bethesda, MD, between the hours of 8:15 a.m. and 4:00 p.m. Eastern Time.
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(e) Citation of Regulatory Requirement. All correspondence, reports, and other written comunications submitted to the Nuclear ,
Regulatory Comission pursuant to the regulations of this part must -
reference the applicable regulation in the upper right corner of the g/#o. b,"
first page of the submittal.
.e.
79 (f) Conflicting Requirements. If there is a conflict between the Comission's regulations in this part, a license condition or technical specification, or other written Commission approval or authorization pertaining to the submittal requirements for the same type of application or report, the submittal requirements specified in the regulations in this part for the applications and reports apply unless the Commission, pursuant to 550.12 cf this prt, grants a specific exemption from the submittal requirements specified in the regulations in this part.
./p*t d k N T 9 In 550.12,/ paragraph (b) is revised to read as follows:
2.
g.c.
550.12SpecificExemotions.
(b) Any person may request an exemption permitting the conduct of activities prior to the issuance of a construction permit prohibited by 550.10. The request must be submitted as specified in 550.4. The Comission may grant such an exemption upon considering and balancing the following factors:
- 11 .
)
- 3. In 550.30, paracraphs (a) and (b) are revised to read as foliov.;
and paragraph (c) is removed. _M
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550.30 s nmW of applicationsph'lelopfM %@"c- %-
(a) Serving of applications. 4 ,
(1) Each filing of an application for a license to construct and/or operate a production or utilization facility (including amendments to the applications) must be submitted to the U.S. Nuclear Regulatory Cocynission in accordance with $50.4.
(2) An additional 10 copies of the general information and 30 copies of the safety analysis report, or part thereof or amendment thereto, must be retained by the applicant for distribution in accordance with the written instructions of the Director, Office of Nuclear Reactor Regulation, or the Director, Office of Nuclear Material Safety and Safeguards, as appropriate.
(3) Each applicant shall, upon notification by the Atomic Safety and Licensing Board appointed to conduct the public hearing required by the Atomic Energy Act for the issuance of a construction permit, update the application and serve the updated copies of the application or parts of it, eliminating all superseded information, i together with an index of the updated application, as directed by the Atomic Safety and Licensing Board. In addition, at that time the applicant shall serve the Atomic Safety and Licensing Appeal Panel. Any subsequent amendment to the application must be served on those served copies of the application and must be submitted to the U.S. Nuclear Regulatory Commission as'specified in 550.4.
(4) At the time of filing, o'ne~ copy of each application must be made available in an appropriate office near the site of the proposed facility for inspection by the public and updated as amendments to the application prior to the public hearing may be made. This updated copy must be made available at the public hearing for the use of any other parties to the procaeding.
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(5) The applicant shall certify that tr . u; d in t c ;' 4d of tw application contain the current contents of the application subbitted in accordance with the requirements of this part. The applicant shall update and serve copies of the application and make available a copy of the updated application in an appropriate office near the site of the facility for inspection by the public.whenever the Comission may issue a notice of public hearing concerning the issuance of an operating license.
(6).The serving of copies required by this section must not occur until the application has been docketed pursuant to 52.101(a) of this chapter. Copies must be submitted to the Comission, as specified in 550.4, to enable the Director, Office of Nuclear Reactor Regulation,
- or Director, Office of Nuclear Material Safety and Safeguards, as appropriate, to determine whether the application is sufficiently complete to pr7 nit docketing.
(b) Dath or affirmationj f
Each application for a license, including whenever appropriate a construction permit, or amendment of it, and each amendment of each application must be executed in a signed original by the applicant or duly authorized officer thereof under oath or affirmation.
i
- 4. In 550.36, paragraph (c)(5) is revised to read as follows: 1 J2.c - i 550.36 Technical pecifications.
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1 (c) t l (5) Administrative controls. Administrative controls are the
! provisions relating to organization and management, procedures, recordkeeping, i
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review and audit , a nd re;tr ir ; neces sa r., :o er s_rc cpc ratiu c ' it.c facility in a safe manner. Eech licensec shali submit any reports to the Comission pursuant to approved technical specifications as specified in 550.4.
- 6. In 550.36a, paragraph (a)(2) is revised to read as follows:
550.36a Technical specifications on effluents from nucleanpower reactors.
(a)
(2) Each licensee shall submit a report to the Comission within 60 days after January 1 and July 1 of each year, that specifies the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in gaseous effluents during the previous six months of operation, including any other information as may be required by the Coranission to estimate maximum potential annual radiation doses to the public resulting from effluent releases. The report must be submitted as specified in 550.4. If quantities of radioactive materials released during the reporting period are significantly above design objectives, the report must cover this specifically. On the basis of these reports and any additional information the Comission may obtain from the licensee or others, the Comission may require the licensee to take action as the Comission deems appropriate.
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- 6. In 550.49, paragraphs (h) and,(i) are revised to read as follows:
550.49 Environmental qualifica1ioILQf electric equipment imgant to safety for nuclear _ power plants.
14
( r. ) Lan lia r.s ec t hil r,c tify tu Ec u.,at spc;ifiec in 150.4, of any sicnificant equipment qualifiution preblem that may require extension of the completion date provided in accordance with paragraph (g) of this section within 60 days of its discovery.
M Wt b (i) h rs @ operating licenses granted after February 22, 1983, but prior to November 30, 1985, shall perform an analysis to ensure that the plant can be safely operated pending completion of equipment qualification required by this section. This analysis must be submitted, as specified in 550.4, for consideration prior to the granting of an operating license and must include, where appropriate, consideration of:
pW
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- if 7.
,pffT In g50.54,jparagraphs (a)(3)j arid (a)(3)(1), (f), (p), (q), and (w)(4) are revised to read as follows:
550.54 Conditions of licenses.
(a)
(3) After March 11,_1983, each licensee described in paragraph (a)(1) of this section may make a change to a previously accepted quality assurance program description included or referenced in the Safety Analysis Report, provided the change does not reduce the comitments in the program description previously accepted by the NRC. Changes to the quality assurance program description that do not reduce the commitments must be submitted to the HRC at least annually in accordance with the requirements of $50.71 Of thh put. Changes to the quality assurance program description that do reduce the comitments must be submitted to NRC and receive NRC approval prior to implementation, as follows:
15
(i) Chenps tea a ine Safety Analysis hpr: u !c L utmi t ted ,
as specified in 150.4. Chences made to NRC-accepted cuality assurance topical report descriptions must be submitted, as specified in 550.4.
(f) The licensee shall at any time before expiration of the license, upon request of the Comission, submit, as specified in 550.4, written statements, signed under oath or affirmation, to enable the Comission to determine whether or not the license should be modified, suspended, or revokecfg) . b (p) The licensee shall prepare and maintain safeguards cgtgn plan procedures in accordance with Appendix C of 10-EfR part 73 A for making decisions and the actions contained in the Responsibility Matrix of the safeguards contingency plan. .The licensee may make no change
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which would decrease the effectiveness of a security plan prepared pursuant to 550.34(c) or Part 73 of this chapter, or of the first four categories of information (Background, Generic Planning Base, Licensee Planning Base, Responsibility Matrix) contained in a liceng safe rds contingency plan prepared pursuant to 550.34(d) or Part h3 3 without prior approval of the Commission. A licensee desiring to make such a chahge shall submit an application for an amendment to a license pursuant to
%eA< M 550.90. The licensee may make changes to the security plan or to the safeguards contingency plan without prior Commission approval if the g'p l changes do not decrease the safeguards effectiveness of the plan. The l licensee shal1 ma.intain records of changes to the plans made without l
prior Comission approval for a period of two years from the date of the l .
change, and shall submit, as specified in 550.4, a report containing a description of each change within two months after the change is made.
Prior to the safeguards contingency plan being put into effect, the licensee shall have:
I 16 l
(y, A iicensee autnori:c: te p: u ess aid /or operate a nuclear porer rentor shall follow and maintain in effect eriergency plans which meet the standards in 550.47(b) ;f this p ut and the requirements in Appendix E to this part. A licensee authorized to possess and/or operate a research reactor or a fuel facility shall follow and maintain in effect emergency plans which meet the requirements in Appendix E of this part. The nuclear power reactor licensee may make changes to these j plans without Comission approval.only if the changes do not decrease p 2 ur*' ,<
the effectiveness of the plans and the plans, as changed, continue to g
A meet the standard of 550.47(b) f thi:; pcrt and the requirements of -
Appendix E of this part. The research reactor licensee and/or the fuel facility licensee may make changes to these plans without Comission approval, only if these changes'do not decrease the effectiveness of the plans and the plans, as changed, continue to meet the requirements of Appendix E of this part. Proposed changes that decrease the effectiveness of the approved emer'gency plans shall not be implemented without application to and approval by the Comission. The licensee shall submit, as specified in 550.4, a report of each proposed change for approval. If a change is made without approval, the licensee shall submit, as specified in 550.4, a report of each change within 30 days after the change is made.
i (w)
(4) The licensee shall report, as specified in 550.4, on April 1 of each year, the present levels of insurance or financial protection it maintains and the sources of the insurance or protection.
- 8. In 550.55, paragraphs (e)(3), (f)(3), and (f)(3)(i) are' revised to l read as follows:
l 550.55 Conditions of construction permits.
l * * * * *
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17 L
- o "
(t )
(3)(i) The holder ~ of' a construction permit shall also submit, as specified in 550.4, a written report on a reportable deficiency within 30 days.
(ii) The report must include a description of the deficiency, an analysis of the safety implications and the corrective action taken, j ano sufficient information to permit analysis and evaluation of the deficiency and of the corrective action. If sufficient information is not available for a definitive report to be submitted within 30 days, an interim report containing all available information shall be filed, as specified in 550.4, together with a statement that indicates when a complete report will be filed.
e .* * *
- 1 (f) * * *
(3) After March 11. 1983, each construction permit holder described in paragraph (f)(1) of this section may make a change to a previously accepted quality assurance program description included or referenced in the Safety Analysis Report, provided the change does not reduce the i commitments in the program description previously accepted by the NRC.
l-Changes to the quality assurance program description that do not reduce the commitments must be submitted to NRC within 90 days. Changes to the quality assurance program description that do reduce the commitments must be submitted to NRC and receive NRC approval before implementation, as follows: .
(i) Changes to the Safeky Analysis Report must be submitted for l review as specified in 350.4. Changes made to NRC-accepted quality assurance topical report descriptions must be submitted as specified in 550.4.
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- 9. In _550.55a, paragraphs (c)(5)(ii) an: (;)(E)(iii'; art revised te read as follows:
ISO.55a Codes and standards.
l (g) Inservice inspection requirements, f$ t # 40 (5)
(ii) If a revised inservice inspection program for a facility conflicts with the technical specification for the facility, the licensee shall apply to the Commission for amendment of the technical specifications l
l to conform the technical specification to the revised program. The licensee shall submit this application, as specified in 550.4, at east i six months before the start of the period during which the provisions become applicable, as determined by paragraph (g)(4) of this section.
l l
(iii) If the licensee has determined that conformance with certain code requirements is impractical for its facility, the licensee shall notify the Commission and submit, as specified in 550.4, information to support the determination!.
- 10. In 550.59, paragraph (b) is revised to read as follows:
550.59 Changes, tes_ts and avnerime0h.
[
\
(b)(1) The licensee shall maintain records of changes in the facility and of changes in procedures made pursuant to this section, to the extent that these changes constitute changes in the facility as 19
described in tv :4 ' ( ' , cnaly is rc m ; e- tv the e t i t ' '. ;N: t '. ty constitute changc ir, procedures as descriced in the safc;y analysis report. The licensee shall also maintain records of tests and experiments carried out pursuant to paragraph (a) of this section. These records must include a written safety evaluation which provides the bases for the determination that the change, test, or experiment does not involve an unreviewed safety question.
(2) The licensee shall submit, as specified in 350.4, a report containing a brief description of any changes, tests, and experiments, including a summary of the safety evaluation of each. The report must be submitted annually or at such shorter intervals as may be specified in the license.
(3) The records of-changes in the facility shall be maintained until the date of termination of the license, and records of changes in procedures and records of tests and experiments shall be maintained for a period of five years.
- 11. In 550.71, paragraphs (a), (b) and (e)(1) are revised to read as follows: j,36 p w ?
550.71 Maintenance of records, making of reports.
(a) Each licensee and each holder of a construction permit shall l maintain all records and make all reports, in connection with the activity, as 'may be required by the conditions of the license or permit l
or by the rules, regulations, and orders of the Comission in effectuating v
the purposes of the Act, including 5105 of the Act. Reports must be submitted in accordance with 550.4.
(b) With respect to any production or utilization facility of a type described in 5550.21(b) or 50.22, or a testing facility, each i
20
licensee and cad. holder of a anmuction permit shall subri: i ts annual financial report, including the certified financial statements, to the Commission as specified in 550.4 upon issuance of the report.
(e)
(1) The licensee shall submit revisions containing updated information to the Commission as specified in 550.4 on a replacement-page basis that is accompanied by a-list which identifies the current pages of the FSAR following page replacement.
- 12. In 550.73, paragraphs (c), (d), and (f) are revised to read as follows:
550.73 Licensee event report system.
(c) Supplemental information. The Commission may require the licensee to su.bmit specific additional information beyond that required ,
by paragraph (b) of this section if the Commission finds that supplemental material is necessary for complete understanding of an unusually complex or significant event. These requests for supplemental information will be made in writing and the licensee shall submit, as specified in 550.4, the requested information as a supplement to the initial LER.
(d) Submission of reports. Licensee Event Reports must be prepared on Form NRC 366 and submitted within 30 days of discovery of a reportable event or situation to the U.S. Nuclear Regulatory Commission, as specified in 550.4.
21 t , y _ - -- - ..,,.--.-..-r-r - --. , -..--- - -_- - - - . ,
(f) /equests R for exemptions to the reporting requirements under this section must include adequate justification and be submitted as specified in 550.4.
Upon a request or at the initiation of the NRC staff, the NRC Executive Director for Operations may, by a letter to the licensee, grant exemptions to the reporting requirements under this section.
- 13. In550.82, paragraph (a) is revised to read as follows:
550.82 Applications for termination of licenses.
(a) Any licensee may submit an application to the Commission as specified in 550.4 for authority to surrender a license voluntarily and to dismantle the facility and dispose of its component parts. The Commission may require information, including information as to proposed procedures for the disposal of radioactive material, decontamination of the site, and other procedures, to provide reasonable assurance that the dismantling of the facility and disposal of the component parts will be performed in accordance with the regulations in this chapter and will not be inimical to the common defense and security or to the health and safety of the public.
- 14. Section 50.90 is revised to read as follows: . . , _
550.90 Application for amendme_nt of license or construction permit.
I
{
l 22
Whenever a holctr of 2 license or cor.struction permit desires to amend the license or permit, application for an amendment must be filed, as specified in 150.4 with the Commission, fully describing the changes desired, and following as far as applicable the form prescribed for original applications.
- 15. In 550.91, paragraph (a)(1) is revised to read as follows:
550.91 Notice for public comment; State consultation _.
(a) Notice for public com ent. (1) At the time a licensee requests an amendment, it must provide, as specified in 550.4, to the Commission its analysis, using the standards in 550.92, about the issue of no significant hazards considerationd)?
- 16. In 550.109, paragraph (c) is revised to read as follows:
150.109 Backfitting.
(c) The Commission may at any time require a holder of a construction permit or a license to submit, as specified in150.4, any information concerning the addition or proposed addition, the elimination or proposed elimination, or the modification or proposed modification of structures, systems, or components of a facility that it deems appropriate.
23
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- 17. In Appcndix E, section V is revised to read n k iitw::
Appendix E - EMERGENCY PLANNING AND PREPAREDNESS FOR PRODUCTION I
AND UTILIZATION FACILITIES qb 10 V. Implementing Procedures [
No less than 160 days prior to the scheduled issuance of an operating license for a nuclear power reactor or a license to possess nuclear material, the applicant shall submit detailed implementing procedures for its emergency plan to the Commission as specified in 550.4. In cases where a decision on an operating license is scheduled less than one year after November 3,1980, the licensee shall submit such implementing procedures as soon as practicable, but before full power operation is authorized. Prior to March 1,1981, licensees who are authorized to operate a nuclear power facility shall have submitted the licensee's emergency plan implementing procedures to the Administrator of the appropriate NRC Regional Office. Any changes to maintain these implementing procedures up-to-date must be submitted, as specified in 550.4, within 30 days of these changes.
I HRC staff has developed two regulatory guides: 2.6 " Emergency Plannir.g for Research Reactors," and 3.42 " Emergency Planning in Fuel Cycle Facilities and Plants Licensed Under 10 CFR Parts 50 and 70," and a joint HRC/ FEMA report, NUREG-0654: TEMA-REP-1 " Criteria for Preparation and Evaluatio.n of Radiological Emer[ency Response Plans and Preparedness in Support of Nuclear Power Plants for Interim Use and Coment," January 1980, to provide guidance in developing plans for coping with emergencies.
Copies of these documents are available at the Commission's Public Document Room 1717 H Street, Ny Washington, QL20555. Copies of these documents may be purchased from,the Government Printing Office. Information )(
on current prices may be obtained by writing the U.S. Nuclear Regulatory Commission, Washington, QCo 20555, Attention: Publications Sales Manager.
K
. 24
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lt. In Appendix G, section V, rcragra;t i is revised to read 25- fci h .
AppendixG-FRACTURETOUGHNESSREQUIREMENTS[
V. Inservice Requirements - Reactor Vessel Beltline Material j
/
E. The proposed programs for satisfying the requirements of sections V.C. and V.D. of this appendix must be submitted as specified in 550.4, for review and approval on an individual case basis at least three years prior to the date when the predicted fracture toughness levels will no longer satisfy the requirements of section V.B. of '. bis appendix.
- 19. In Appendix H, section II, paragraph B.3 and section III, paragraph A are revised to read as follows:
Appendix H - REACTOR VESSEL MATERIAL SURVEILLANCE PROGRAM REQUIREMENTS,/
II. Surveillance Program Criteria B. * * *
- 3. A proposed withdrawal schedule must be submitted with a
. . . . technical justification as specified in 550.4. The proposed schedule must be approved prior to implementation.
25
III. k g rt of h st Result:
A. Each capsule withdrawal and the test results must be the subject of a summary technical report to be submitted as specified in
$50.4 within one year after capsule withdrawal unless an extension is granted by the Director, Office of Nuclear Reactor Regulation.
- 20. In Appendix I, section IV, paragraph A.3 and paragraph A.3.a of the " Concluding Statement on Position of the Regulatory Staff (Docket-RM-50-2)" are revised to read as follows:
Appendix I - NUMERICAL GUIDES FOR DESIGN OBJECTIVES AND LIMITING CONDITIONS FOR OPERATION TO MEET THE CRITERION f/
Q). . .
7 u mw:-g Sec. IV. Guides on technical specifications for limiting conditions for operation for light-water-cooled nuclear power reactors licensed under 10 CFR Part 50.
A. * *
- l
- 3. Report these actions as specified in 650.4, within 30 days from the end of the quarter during which the release occurred.
l I
Concluding Statement on Position of the Regulatory Staff (Docket-RM- 50-2) 26 l
A.
- 3. * *
- a. The applicant submits, as specified in 550.4, an evaluation of the potential for effects from long-term buildup on the environment in the vicinity of the site of radioactive material, with a radioactive half-life greater than one year, to be released; and
- 21. In Appendix J, section V, paragraph B.l. is revised to read as follows:
Appendix J - PRIMARY REACTOR CONTAINMENT LEAKAGE TESTING FOR WATER-COOLED POWER REACTORS,y
/
V. Inspection and Reporting of Testsf/
B. Report of test results. 1. The preoperational and periodic tests must be the subject of a summary technical report submitted to the Commission as specified in 550.4 approximately three months after the conduct of each test. The report must be titled " Reactor Containment Building Integrated Leak Rate Test."
l
- 22. In Appendix K, section II, paragraph 1.c. is revised to. read as follows:
Appendix K - ECCS EVALUATION MODELS 27
~
II. Eeauired Pacumentation
- 1. * * *
- c. The licensee shall submit to the Comission as specified in 560.4, a complete listing of each computer program, in the same form as used in the evaluation model.
- 23. In Appendix M. Paragraph 2 is revised to read as follows:
Appendix M - STANDARDIZATION OF DESIGN; MANUFACTURE OF NUCLEAR POWER REACTORS; CONSTRUCTION AND OPERATION OF NUCLEAR POWER REACTORS MANUFACTURED PURSUANT TO COMMISSION LICENSE
- 2. An application for a manufacturing license pursuant to this Appendix M must be submitted as specified in 550.4 and meet all the requirements of 5550.34(a)(1)-(9) and 50.34a (a) and (b), except that the preliminary safety analysis report shall be designated as a " design report" and any required information or analyses relating to site matters shall be predicated on postulated site parameters which must be specified in the application. The application must also include information pertaining to design features of the proposed reactor (s) that affect
! plans for coping with emergencies in the operation of the reactor (s).
l * * * *
- _
- 24. In' Appendix N, paragraph 2. is revised to read as follows:
APPENDIX N - STANDARDIZATION OF NUCLEAR POWER PLANT DESIGNS:
LICENSES TO CONSTRUCT AND OPERATE NUCLEAR POWER l
. REACTORS OF DUPLICATE DESIGN AT MULTIPLE SITES 28
- 2. A;Tlicaticos for construction permits submit ec pursuant te tnis absendix must' include the information required by 550.33, 50.33a, 50.34(a) and 50.34a(a) and (b) and be submitted as specified in 550.4. The applicant shall also submit the information required by 561.IO of this chapter. # M M E
4 t
- 25. In Appendix 0, paragraph 2 is revised to read as follows:
4 Appendix 0 - STANDARDIZATION OF DESIGN; STAFF REVIEW OF STANDARDDESIgNS j -
i
- 2. The submittal for review of the standard design must be made in the same manner and in the same number of copies as provided in 5550.4 and 50.30 for license applications.
- 26. In Appendix Q, paragraph 2 is revised to read # '
Appendix Q - PRE-APPLICATION EARLY REVIEW 0F SITE SUITABILITY ISSUES a
'2 . The submittal for early review of site suitability issue (s) must be made in the same manner _and,in the same number of copies as provided in $550.4 and 50.30 for license applications. The submittal i
must include sufficient information concerning a range of postulated
! facility design and operation parameters to enable the Staf.f to perform the requested review of site suitability issues. The submittal must contain suggested conclusions' on the issues of site suitability submitted for review and must be accompanied by a statement of the bases or the
, 29 .
6
reasons for these conclusions. The submi:til r.;st also list, it the extend possible, any long-range objectives for ultimate developmer.: of the site, state whether any site selection process was used in preparing the submittal, describe any site selection process used, and explain what consideration, if any, was given to alternative sites.
Dated at Bethesda, Maryland, this day of 198)
For the Nuclear Regulatory Commission.
William J. Dircks, Executive Director for Operations 6
4 30
M< ' .a y k b si; o- F.k . ; en 3 tit:
"Comn. wiims F'roceduru k mdmm .10 Ui f '
INTRODUCTION In accordance with the regulatory analysis guidelines established by the Office of the Executive Director for Operations (EDO) December 13, 1982 memorandum to Office Directors and Regional Administrators, a. regulatory analysis has been prepared for the proposed rule entitled "10 CFR Part 50
- Communications Procedures Amendments." Although the proposed rule does not meet the threshold criteria mandating a regulatory analysis, the ED0 has directed that other rulemaking actions should also be supported by a less detailed analysis based on the Regulatory Analysis Guidelines (NUREG/BR-0058).
STATEMENT OF PROBLEM The current 10 CFR 50 regulation contains vague, confusing, and outdated directions regarding the proper procedures for submitting written communication to the U.S. Nuclear Regulatory Commission (NRC). For example, fewer than half of the 50 types of reports and applications required by 10 CFR 50 have clear directions that tell licensees where to send submittals and how many copies to send. This situation causes cc iusion for applicants and licensees subject to 10 CFR 50. Efforts to clarify the submittal procedures resulted in the issuance of Regulatory Guide 10.1 (Revision 4) " Compilation of Reporting Requirements for Persons .
Subject to NRC Regulations" and NRR Generic Letter 82-14 " Submittal of Documents to the Nuclear Regulatory Commission." Although these guidance documents addressed the problem, they did not entirely resolve the confusion. Moreover, subsequent changes in the NRC organizations and their functional responsibilities added to the confusion. New document dissemination requirements have developed as a result of the. Resident Inspector Program, Regionalization, the formation of the Office of
~
Resource Management, the establishment of the NRC Document Control Desk, etc. .
The proposed amendments are expected to resolve confusion regarding submittal procedures and improve the communication process with the affected applicants and licensees. In addition, the amendments would reduce postage and copying costs for licensees and would result in a small reduction in administrative burden for NRC.
The effective mhnagement of the receipt, control, and dissemination of correspondence, reports, applications, and other written communications pertaining to the domestic licensing of production and utilization facilities is essential to accomplishing the NRC's fourfold mission of:
protecting the public health and safety, protecting the environment, safeguarding nuclear materials, and assuring conformity with antitrust O
laws. The propesed araendnents would improve the connunication process between NRC staff and licensees. The present regulations continaally cause problems for the Office of Nuclear Reactor Regulation, the Office of Inspection and Enforcement and the Regional Offices. These offices helped the Office of Administration develop the proposed rule and they support its promulgation.
OBJECTIVE The proposed amendments would clarify the submittal procedures of 10 CFR 50 and improve the communication process between NRC and licensees.
Specifically, the proposed amendments would:
o Simplify the procedures for making 10 CFR 50 submittals to the NRC.
Address Requirement Licensees and applicants would be required to submit all written communication to the Document Control Desk, U.S.
Nuclear Regulatory Connission, Washington, DC 20555, the appropriate Regional Office, and the NRC Resident Inspector (if applicable). The present regulations are not specific or consistent in this regard.
Copy Requirements Standard copy requirements would be established. With few exceptions, the amendment would require three copies of reports and 40 copies of applications. The current copy requirements vary considerably according to submittal type.
Submittal Directions By. clarifying the submittal procedures, the proposed amendments would reduce delays in document processing caused when a licensee sends an insufficient number of copies or uses an incorrect address.
Facilitate the timely dissemination of 10 CFR 50 submittals to NRC staff, national laboratories, and public document rooms.
By requiring licensees to submit communications directly to NRC Headquarters, the Regions, and the Resident Inspectors, NRC staff would avoid unnecessary delays in receiving submittals. For example, Regional Offices would no -
longer need t6 re-submit licensee submittals to Headquarters since Headquarters would receive the submittal directly (and more quickly) from the licensee.
O
l l
l Establish an NRC central control point for 10 CFR submittals.
As the primary submittal point, the Document Control Desk would
. receive all written communications. This would greatly improve NRC's document control efforts and lessen the likelihood of the staff being unable to locate critical documents.
Include the NRC Resident Inspectors in the formal comunication process between licensees and NRC.
The amendments would require licensees to send copies of submittals directly to the appropriate Resident Inspector. This would fomalize a distribution action already perfomed by many licensees and eliminate the need to re-transmit submittals from the Regions to the Resident Inspectors.
Require applicants and licensees to cite the specific regulation governing a 10 CFR 50 submittal.
A specific regulation citation will help the NRC document control staff select the appropriate NRC distribution list for a submittal.
This would improve the accuracy of distribution coding and reduce the need for remedial actions caused by distribution errors.
Supersede all outdated submittal directions contained in other sources of submittal guidance, such as Regulatory Guide 10.1 (Revision 4), NRR Generic Letter 82-14, and the technical specifications of operating licenses.
The proposed amendments would correct the deficiencies found in the other sources of submittal guidance. After the promulgation of the rule, revised guidance documents will be issued. -
ALTERNATIVES
- 1. Clarify by amendment the submittal procedures in 10 CFR 50.
- 2. Revise the existing guidance documents addressing submittal procedures.
- 3. Incorporate submittal procedures into the technical specifications of individual operating licenses issued under 10 CFR 50.
CONSEQUENCES
~
- a. Cost and Benefits of Alternatives Alternative 1. Amend 10 CFR 50 Effects on Ir.Justry Amending 10 CFR 50 will result in a small savings for nuclear generating facilities by reducing the burden of copying and transmitting I
w
submittals to NRC. An annual aggregate savings of $140,000 is estimated. Approximately 2.2 million fewer pages of submittals would be sent to NRC annually. This would reduce copying costs by
-$110 thousand and postage costs by $28 thousand. Attachment 1 provides the cost analysis in greater detail.
Effects on NRC The proposed amendments are expected to; Eliminate the need to re-transmit 10 CFR 50 submittals between Headquarters and the Regions.
- Speed up the dissemination of 10 CFR 50 submittals to NRC staff.
Reduce problems and delays caused by deficient 10 CFR submittals.
An annual savings of $14 thousand in postage costs is estimated.
Approximately 1 million fewer pages would be mailed. One million pages is about 273 thousand ounces. Two hundred seventy three thousand times $.05 (average bulk postal rate per ounce) equals a savings of approximately $14 thousand. Preparing and publishing the rule would cost NRC approximately 320 hours0.0037 days <br />0.0889 hours <br />5.291005e-4 weeks <br />1.2176e-4 months <br /> of staff time at
$60 per hour for a total cost of $19,200.
Effects on Public Besides facilitating public access to 10 CFR 50 submittals through the Public Document Rooms, the proposed amendments are expected to have little effect on the public.
Alternative 2. Revising the existince documents .
Effects on Industry Same as in Alternative 1, estimated annual aggregate cost savings of $140 thousand. However, revising guidance documents without amendming regulations will result in conflicting submittal directions for applicants and licensees.
! Effects on NRC
~
- As in Alternative 1, annual savings ar'e" estimated at $14 thousand and preparing and issuing the revised guidance documents would cost
$19,200.
Effects on Public Same as Alternative 1, little effect on public is expected.
e
Alternative 3. Incorporate submittal procedures into technical specifications of individual operating licenses.
Effect on Industry Same as Alternative 1, estimated annual aggregate savings of $140 thousand.
Effects on NRC As in Alternative 1, annual postage savings are estimated at $14 thousand. The cost of amending each of the individual operating licenses is approximately $874 thousand. It requires approximately 104 professional staff hours to issue a single license amendment.
Amending each of the licenses for the power reactors (75) and nonpower reactors (65) would require 14,560 staff hours. At $60 per hour the total cost is $873,600.
Effects on Public Same as Alter :tive 1, little effect on the public is expected.
- b. Impacts on Other Requirements None of the alternative regulatory actions is expected to impact NRC prograns and licensee operations except as specified in the preceding analysis. There would be no effect on: interagency or intergovernmental agreements between NRC and other agencies, and US international agreements and commitments. ,
DECISION RATIONALE Alternative 1, amending the submittal procedures of 10 CFR 50 is recommen'ded as the regulatory action which would best address the problems occurring with 10 CFR 50 submittals. Merely revising the existing guidance documents, Alternative 2, without amending the regulations will likely cause more confusion about proper submittal procedures. The issuance of revised guidance documents would more appropriately follow the promulgation of the communication amendment.
Alternative 3, incorporating submittal directions into the individual operating licenses, would impose considerable burden on NRC staff and counteract recent efforts to move reporting and recordkeeping requirements from-licenses to the regulations.
Alternative 1 is the most effective method of accomplishing the stated objectives.
9
IMPLEMENTATIO"
- a. Schedule for Implementing the Proposed Requirements o .May 1,1984 - Submit rulemaking to EDO for approval. l May 20, 1984 - Recirculate rulemaking to offices for concurrence.
June 20, 1984 - Submit Rulemaking to CRGR.
July 20,1984 - Publish proposed rule.
September 20, 1984 - Analyze comments on proposed rule.
October 20, 1984 - Publish final rule.
- b. Relationship to Other Existing or Proposed Requirements Licensee Event Report (LER) Rule, 50.72 The LER rule changed submittal procedures for LER's. The Document Control Desk was established as the primary NRC receipt point for event reports. The proposed communications amendment conforms to these directions and formally requires the licen' sees to send copies to the appropriate NRC Resident Inspector.
G
- 6-t
Attachment 1 Cost Data for "Comunications Procedures Amendments,10 CFR 50" (Derived from 1983 Document Statistics from NRC Document Control System) 10 CFR 50 Effect on Applicants and Licensees Submittal Type (Change in number of pages submitted to NRC annually)
I. Applications Increase Reduction No Change 50.12 X 50.30 -1,944,504 50.34(f) X 50.35(b) X 50.49(i) X 50.55a(g)(5)(ii) X 50.73(f) X 50.80 X 50.82(a)
- X 50.90 -52,290
- 50.91 X 50.109 X App. I X App. K X II. Reports 50.35 b) X 50.36c)(1) .
X 50.36 c)(5) -251,960 50.36a(a)(2) +9,152 50.49(g) X 50.49(h)~ X 50.54(a) X 50.54(f) '
X 50.54(w)(4) X 50.55(e)(3) +8,862 50.55a(g)(5)(iii) X 50.59(b) '
-92,352 50.71(a) X 50.73 +5,082 50.109(c) X App. G.V.E. X App. H.II.B.3. X App. H.III.A X App. I.IV.A.3 X App. J.V.B X e
Attachment 1 (Cont'd) 10 CFR 50 Effect on Applicants and Licensees Submittal Type (Change in number of pages submitted to NRC annually)
III. Acceptance Review Increase Reduction No Change Application 50.30(c)(3) -26,760 IV. Security Plan Submittals 50.34 X 50.54(p) X 50.90 X V. Emergency Plan Submittals 50.34 -31,320 50.54(q) +46,255 .
App. E.V. +148,190 VI. Updated FSAR 50.71(e) x TOTAL INCREASE TOTAL REDUCTION
+217,541 -2,424,280 .
' NET CHANGE IN PAGES SUBMITTED
-2,206,439 l
l Cost Savings for Nuclear Generating Facilities Savings in copying costs:
l 2,206,439 pages x $.05 (per page copy cost) = $110,321, c .
l Savings in postage costs:
2,206,439 pages weighs 551,609 ounces 551,609 ounces x $.05 (average bulk postal rate per ounce) =
$ 27,580 l
l I . i l
V .
Results of Preliminary Office Review of Rulemaking Titled "Comunications Procedures Amendments,10 CFR 50"
~
Issue to be Addressed The current 10 CFR 50 regulation contains vague, confusing, and outdated directions regarding the proper procedures for submitting written comunication to the U.S. Nuclear Regulatory Commissio'n (NRC). For example, fewer than half of the 50 types of reports and applications required by 10 CFR 50 have clear directions that tell licensees where to send submittals and how many copies to send. This situation causes confusion for applicants and licensees subject to 10 CFR 50. Efforts to clarify the submittal procedures resulted in the issuance of Regulatory Guide 10.1 (Revision
- 4) " Compilation of Reporting Requirements for Persons Subject to NRC Regulations"- and NRR Generic Letter 82-14 " Submittal of Documents to the Nuclear Regulatory Comission." Although these guidance documents addressed the problem, they did not entirely resolve the confusion.
Moreover, subsequent changes in NRC organizations and their functional responsibilities added to the confusion. New document dissemination requirements have developed as a result of the Resident Inspector Program, Regionalization, the formation of the Office of Resource Management, the establishment of the NRC Document Control Desk, etc.
The proposed amendments are expected to resolve confusion regarding submittal procedures and improve the communication process with the affected applicants and licensees. In addition, the amendments would reduce postage and copying costs fqr licensees and would result in a small reduction in administrative burden for NRC.
Need for Addressing the Issue .
The effective management of the receipt, control, and dissemination of correspondence, reports, applications, and other written comunications pertaining to the domestic licensing of production and utilization facilities is essential to accomplishing the NRC's fourfold mission of:
protecting the public health and safety, protecting the environment, safeguarding nuclear materials, and assuring confonnity with antitrust laws. The proposed amendments would improve the comunication process between NRC staff and licensees. The present regulations continually cause problems for the Office of Nuclear Reactor Regulation, the Office of Inspection and Enforcement and the Regional Offices. These offices helped the Office of Administration develop the proposed rule and they support its promulgation.
i Alternatives to Rulemaking -
- 1. Revise existing guidance documents. ,
The existing guidance documents, Regulatory Guide 10.1 (Resision 4) and Generic Letter 82-14, are based on the regulations of 10 CFR k
e
- 50. Issuing revised guidarce documents without amending the regulations would result in conflicting submittal directions for applicants and licensees and would increase the confusion about submittal procedures. Revired guidance documents would more appropriately follow the promulgation of the communications amendment.
- 2. Incorporate submittal procedures into the technical specifications of individual operating licenses.
This alternative would require the staff to amend each of the operating licenses for approximately 75 power reactors and 65 non-power reactors. Besides requiring a large amount of NRC staff resources this alternative would counteract recent efforts to move reporting and reccrdkeeping requirements from individual licenses to the regulations.
How Issues will be Addressed by Rulemaking The proposed amendments would clarify the submittal procedures of 10 CFR 50 and improve the connunication process between NRC and licensees. Specifically, the proposed amendments would:
Simplify the procedures for making 10 CFR 50 submittals to the NRC.
Address Requirement Licensees and applicants would be required to submit all written consnunication to the Document Control Desk, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, the appropriate Regional Office, and the' NRC Resident Inspector (if applicable). The present regulations are.not specific or consistent in this regard.
, Copy Requirements Standard copy requirements would be established. With few exceptions, the amendment would require three copies of reports and 40 copies of applications. The current copy requirements vary considerably according to submittal type.
Submittal Directions By clarifying the submittal procedures, the proposed amendments would reduce delays in document processing caused when a licensee sends an insufficient number of copies or uses an incorrect address.
Facilitate the timely dissemination of 10 CFR 50 submittals to NRC staff, national laboratories, and Public Document Rooms.
By requiring licensees to submit communications directly to NRC Headquarters, the Regions, and the Resident Inspectors, NRC staff would avoid unnecessary delays in receiving submittals.
For example, Regional Offices would no longer need to re-submit licensee submittals to Headquarters since Headquarters would receive the submittal directly (and more quickly) from the licensee.
Establish an NRC central control point for 10 CFR submittals.
As the primary submittal point, the Document Control Desk would receive all written communications. This would greatly improve NRC's document control efforts and lessen the likelihood of the staff being un.able to locate critical documents.
Include the NRC Resident Inspectors in the fomal communication process between licensees and NRC.
The amendments would require licensees to send copies of submittals directly to the appropriate Resident Inspector.
This would formalize a distribution action already performed by many licensees and eliminate the need to re-transmit submittals from the Regions to the Resident Inspectors.
o Require applicants and licensees to cite the specific regulation governing a 10 CFR 50 submittal.
A specific regulation citation will help the NRC document control staff select the appropriate NRC distribution list for a submittal. This would improve the accuracy of distribution coding and reduce the need for remedial actions caused by dis.tribution errors.
i Supersede all outdated submittal directions contained in other j sources of submittal guidance, such as Regulatory Guide 10.1 (Revision 4), NRR Generic Letter 82-14, and the technical specifications of operating licenses.
The proposed amendments would correct the deficiencies found in the other sources of submittal guidance. After the promulgation of the rule, revised guidance documents will be issued.
l l l
y o .
How the Public, Industry, and l'RC will be Affected Public The rule is expected to have very little effect on the public. The rule would facilitate public access to 10 CFR 50 submittals through the public Document Room.
Industry The rule is expected to affect nuclear generating facilities by reducing the overall burden required to reproduce and transmit submittals to NRC. An annual aggregate savings of $140,000 is estimated for the affected applicants and licensees.
NRC The rule is expected to:
Eliminate the need to re-transmit submittals between Headquarters and the Regions; reducing postage costs.
- Speed up 'the dissemination of submittals to staff.
Reduce problems with deficient submittals for the staff and the docunent control personnel.
An annual savings of $14,000 is expected to result from the reduction in postage costs.
NRC Resources and Scheduling Needed for the Rulemaking preparing and publishing the rule would cost NRC approximately 320 hours0.0037 days <br />0.0889 hours <br />5.291005e-4 weeks <br />1.2176e-4 months <br /> of staff time at $60 per hour for a total of $19,200. No special scheduling of HRC staff resources would be required. e I
e e
ENCLOSURE B DRAFT STAFF RECOMMENDATIONS I
i i
+ ~ - . . . . ., - _ _ . _ , . , , - . _ , --.
i
' Draft staff recomendations. -
RES staff recomends that the specific rulemaking, " Communications Procedures Amendments (10 CFR 50)," sponsored by ADM be continued,
' subject to the following conditions:
o Correct regulatory drafting errors in the draft -
Federal Register notice of proposed rulemaking, o Resolve question of whether this proposed rule amends information collection requirements in 10 CFR Part 50.
o Clarify that amending communications procedures will~
not alter NRC's regionalization policy, particularly with respect to the Fort St. Vrain Nuclear Generating Station.
o Identify forward commitment of. NRC resources whenever_
written communication requirements in 10 CFR Part 50 are added, rescinded, or amended.
ENCLOSURE C l
RESULTS OF RES STAFF REVIEW 4
l i
l 1
- 1. Quality Control Evaluation The rulemaking review package developed by ADM plus telephone calls to staff members indicate that the Agency Contact for the specific rulemaking has taken into consideration the several elements of a rulemaking to be submitted to the ED0 for signature on the Federal Register notice.
At this time, the rulemaking has been submitted to the CRGR and has been exempted from CRGR review.
A draft memorandum from the Director, ADM, transmitting the rulemaking to the EDO for signature indicates that, because of the minor nature of the rulemaking, no public announcement will be issued and no letter will be dispatched to Congressional committees.
Some matters must be resolved, however, before the notice of proposed rulemaking is published in the Federal Register:
oRegulatory drafting errors. The Agency Centact should cause a comprehensive review of the draft Federal Register notice to eliminate numerous regulatory drafting errors. For example, page-2 of the Federal Register notice citestl50.30(c)(1)(1) which would be removed by amendatory language on page 12; page 4 uses the words of issuance for a final rule rather than a proposed rule; proposed 550.4(b)(3) cross-references 550.30(c)(3)whichwouldbe removed by amendatory language on page 12; and, the proposed revision of Appendix E, section V, uses the version before it was revised December 1982.
ePaperwork reduction. The preamble in the Federal Register notice states that this proposed rule amends information collection requirements. ADM staff members, however, are not certain whether the proposed rule does this. It might reduce burden and dollar costs ancillary, but not chargeable to, the reporting and application requirements in 10 CFR l' art 50. If this is true (based on a forthcoming response from OMB), the Agency Contact will have to replace the Paper work Reduction Act statement with one indicating that OMB clearance is not required.
eRegionalization. The proposed revision of 10 CFR 50.4 would remove existing 450.4(c)(1) that delegates authority to the Regional Administrator of Region IV authority and responsibility for implementing selected parts of the Commission's nuclear reactor licensing program for the Fort St. Vrain Nuclear Generating Station. The RES independent reviewer's preliminary judgment is that the proposed rulemaking could avoid raising unnecessary questions by advising interested persons that changing the addressee for signed originals of written communcications will not alter the limited licensing authority for Fort St. Vrain in Region IV as set out in the Comission's Policy Statement on Regionalization (March 1, 1984, 49 FR 7676).
eRelationship to proposed regulations. The proposed rulemaking constitutes a forward commitment by the NRC to amend proposed 350.4 whenever a written communication requirement is added or rescinded in 10 CFR Part 50.
In addition, each new or amended written communication requirement in 10 CFR Part 50 will have to contain a cross-reference to f50.4. The RES independent reviewer's preliminary judgment is that the forward commitment of NRC resources should be identified for the information of all NRC staff likely to be involved in 10 CFR Part 50 rulemaking.
- 2. Evaluation of rulemaking.
- a. The issue to be addressed, i.e., the proolem to be corrected.
Although the current regulations in 10 CFR 50.4 concerned with communi-cations set out specific addresses for del _ivery of written documents by mail or in person, there are many exceptions otherwise specified in 10 CFR Part 50. These exceptions have resulted in the holders of construction permits or operating licenses for production or utilization facilities delivering the originals of some written reports or communications to appropriate NRC Regional Offices. This fractionates the docketing files with respect to original written reports in both NRC Headquarters and Regional Offices.
~
In addition, many reporting requirements in 10 CFR Part 50 do not specify whether the licensee or permit holder must submit a single written report or an original plus multiple copies.
The staff's preliminary-judgment is that the Commission has created the issue of vague and confusing communication procedures over the course of many years of inadequate regulatory drafting practices for final rules codified in 10 CFR Part 50.
1 4
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e -
g 2
- b. The necessity and urgency for addressing the issue.
The necessity for addressing the issue arose, at least in part, when NRC staff proposed to revise Regulatory Guide 10.1, " Compilation of Reporting Requirements for Persons Subject to NRC Regulations," Rev. 4, to identify primary and secondary recipients of reports. The regulatory guide states: "For the most part, neither the NRC's. regulations nor the technical specifications of a facility license specify the number of copies of a report to be submitted by a licensee to the Commission."
The staff had difficulty in specifying the number of copies of reports to be submitted by licensees or permit holders to the Document Conttol Desk (DCD) which was not then identified in the NRC's regulations.
With regard to urgency, the staff's preliminary judgment is that early resolution of thi? issue will make the Commission's Document Control System and Regulatory Information Distribution System (RIDS) more workable and useful at their present stage of development. Also, resource savings by licensees, permit holders, and the NRC will begin to accrue only when the subject rule becomes effective.
- c. Alternatives to rulemaking.
I In addition to the previously discussed Regulatory Guide 10.1, the staff has issued NRR Generic Letter 82-14, " Submittal of Documents to the Nuclear Regulatory Commission." These are guidance documents that do not resolve the issue of specifying the numbers of copies of reports that licensees and permit holders must submit to the Commission.
i The alternative of incorporating report submittal procedures into l technical specifications has been suggested. This would affect only holders of operating licenses and would not affect applicants and
' holders of construction permits.
The staff's preliminary judgment is that there is no appropriate alternative to rulemaking to address the issue.
- d. How the issue will be addressed through rulemaking.
l The proposed rulemaking will undertake several actions:
- 1) Specify the Document Control Desk as the addressee for each signed original report application,,or other written communication.
(Revised 550.4(a)).
- 2) Specify distribution requirements for written communications in connection with applications for construction permits, operating licenses, or amendments of these. (Revised 550.4(b)).
l i
k~ .)
4 3)' Identify.each application ~ requirement and each reporting requirement. -(Revisedss50.4(b)).
- 4) Require the respondent to reference'the applicable regulation
~
in the upper right corner of the first page of the submittal (New550.4(e)).
- 5) In the applicable regulation, cross-reference the revised 650.4 concerned with written communications.
The staff's preliminary judgment is that the proposed rulemaking will address the issue in the short term, but for the long term, the preamble to the proposed rule should consnit the Commission to amending proposed 10 CFR 50.4, " Written communications," whenever the Commission adds or.
rescinds a communications requirement in 10 CFR Part 50, and drafting each new or amended communication requirement to cross-reference 10 CFR 50.4.
- e. How the public, industry, and NRC will be affected as a result of rulemaking, including benefits and costs (risk, occupational exposure, and resources).
The staff's preliminary judgment is that the public will be little affected as a result of the proposed rulemaking except for the potential .
for earlier viewing of some written reports in the Commission's Public Document Room and Local Public Document Rooms.
Industry will benefit from reduced requirements for the numbers of copies of applications and reports that licensees and construction pennit holders must submit annually. One holder of an operating license for the Fort St. Vrain Nuclear Generating Station will be affected to the extent that the respondent will again be required to submit signed originals or written communications -to Washington, D.C.
(Regionalization took place December 8, 1982,'47 FR 55204.)
NRC will benefit to the extent the staff can utilize DCD and RIDS more efficiently. There will, however, be 3 resource costs:
e The files of signed originals of written communications for the Fort St. Vrain Nuclear Generating Station will have to be transferred from Region IV to the DCD and consolidated in Washington, D.C.
e _ The staff- will have to include a confonning amendment to 10 CFR 50.4 in each rulemaking that adds or recinds a communication requirement-in 10 CFR Part 50 and will have to draft each new, rescinded, or amended consnunication requirement to cross-reference 10 CFR 50.4 e NRR staff will likely withdraw NRR Generic Letter 82-14 and-other staff likely will revise Regulatory Guide 10.1 to reflect the amended communications procedures in 10 CFR Part 50.
The staff's preliminary judgment is that, for the public, industry, and NRC, the resources benefits exceed the resources costs.
J
- 3. The need for the rulemaking.
The need for t proposed rulemaking lies in the application and reporting re u ents as set out in existing 10 CFR Part 50. Many of the sections concerned with application and reporting requirements are silent with respect to the numbers of copies of written connunications that licensees and permit holders should submit to the Commission. In at least one case (10 CFR 50.55(f)(3)(i)), changes made to NRC-accepted quality assurance topical report descriptions must be submitted to an outdated addressee (NRC Region IV Vendor Program Branch).
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- 4. Consistency of the rulemaking with applicable policies and I planning guidance.
The staff's preliminary judgment is that the rulemaking does not create any inconsistency in policy and planning guidance for collecting operating (and other) data without hindering plant operation. Also, this issue which affects numerous licensees is being addressed in the context of rulemaking rather than case-by-case.
4 t
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- f. NRC resources and scheduling needed for rulemaking.
The staff's preliminary judgment is that ADM's estimate of approximately 320 hours0.0037 days <br />0.0889 hours <br />5.291005e-4 weeks <br />1.2176e-4 months <br /> to prepare and publish the rule is reasonable if the resources expended to date are considered sunk costs and the staff time applies to preparing and publishing the proposed rulemaking.
With regard to scheduling, the staff's preliminary judgment is that ADM's estimate of publishing a notice of proposed rulemaking in June 1984 is optimistic. The notice will have to undergo at least one more comprehensive retyping to prepare it for office concurrence prior to signature by the Executive Director for Operations.
- 5. The importance of the rulemaking relative to accomplishing the NRC mandate.
By its nature of being concerned with improving the communications process with affected Part 50 applicants and licensees, and proposed rulemaking is of. low importance relative to accomplishing the NRC's-mandate. The proposed rulemaking, per se, will not affect the public health and safety, the environment, or the safeguarding of nuclear materials.
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(a) Except where otherwise spectned er except as provided under a regional hconalns pro paragraph (c)grom identined isof this section, any communication or report concerning the regulations in this part and any application Bled under these regulations may be submitted to the Commisalon as follows:
Nuc) l ear Reactor Regulation. U.S.(1 By mal! a3 dressed to-Director of Nuclear Regulatory Commission.
Washington. D C 306ss.
(2) By delivery in person to the Commission offices at-(i)1717HStreet NW., Washington, D.C.:or (11)?920 Norfolk Avenue Bethesda.
(b)Before makhg any subenittalla microform, the applicant or Ikensee shall cantact the Division of Technical Information and Document Control. UA
- Nuclear Regulatory Commiselon.
- Washington. D.C 30665. Telephone (301
- 4e2-45a5, to obtain spec 18 cations and )
a copy requirements.
p (c)(1) The Commission has delegated to the Regtanal Administrator of Reglos IV authority and responsibility for implementing selected parta ofits nuclear reactor licenalng program for the Fort St. Vrain Nuclear Genereting Station.
(2) Any application Bled under the regulations to this part and any Ingairy, communication, informatic,n. or report relating to the Fort St. Vrain Nuclear i
Generating Station must be submitted to i the Regional Administrator RegionIV, U.S. Nuclear Regulatory Commission, et t Ryan Plass Drive. Suite 10DIL Arlington. Texas 7e011. Upon receipt.
the Reponal Administrator of Region IV or his aestynee will transmit to the Director of Nuclear Reactor Regulation i any matter which is not within the scope of the Regional Administrato(s "
delegated licensing authority.
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#* "'%eg UNITED STATES 4 t NUCLEAR REGULATORY COMMISslON WASHINGTON, D.C. 20555 OCT 121984 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING Based on our review of the ongoing RES-sponsored rulemaking, " Copying of Records and Retention Periods for Security Records," RES recommends that it be withdrawn in its entirety and a new rulemaking be initiated to specify record retention periods for security records. The results of this independent review endorse my previous findings (attached) and has been coordinated with I&E, the user office. In summary, the basis for my recommendation is as follows: o RES agrees with I&E that the public comments on the published proposed rulemaking concerning the potential for inadvertent disclosure of proprietary information are valid and that the current practice of. licensees routinely providing needed records to the NRC without expense to the Commission is sufficient to protect the health and safety of the public and safeguard special nuclear material. o Since OMB requires that a record retention period be specified for any record that is required by a regulation, a new rulemaking to amend 10 CFR-73.70 to specify record retention periods for security records should be initiated. There are significant changes in format, language, and retention period required; therefore, it must be republished as a proposed rule. The complete RES review package has been sent to OEDO (Attention: DEDROGR) and to the Director, I&E. f>. Wu Robert B. Minogue, Director Office of Nuclear Regulatory Research l I l , l l I i i
#""% UNITED STATES e k. NUCLEAR REGULATORY COMMisslON f ?
j a WASHINGTON, D.C. 20555
\...../ AUG 3 01964 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
REVIEW BY ED0 0F ONGOING RULEMAKING " COPYING 0F RECORDS AND RETENTION PERIODS FOR SECURITY RECORDS" SPONSORED BY RES As a result of the review of the subject ongoing rulemaking for which RES is the sponsoring office, we recomend termination of this rulemaking. The lack of_ explicit authority to copy licensee records was originally identi- ' fied by I&E as an area of concern which could adversely affect its ability to conduct inspections and investigations. To address this concern, a proposed rule to provide this authority was published for coment in November 1983. This rule also contained an amendment spebifying retention periods for safe-guards records. It is current practice for licensees to routinely provide needed records to the NRC without expense to the Commission. Further, most of the public coments received on the proposed rule expressed concern regarding the poten-tial for inadvertent disclosure of proprietary information. Given the history of satisfactory cooperation by the licensees and the increased potential for i disclosure of proprietary information that may result from the rule, there is no need, at this time, for a generic resolution on copying of records. The need to specify the retention period for security records still exists. ADM has out for office concurrence a proposed rule, " Retention Periods for Records," whose purpose is to close all remaining open ended recordkee)ing requirements in NRC regulations. Simply modifying the ongoing ADM rulema cing l for specifying these record retention periods for physical security records is not possible at this time because the subject RES proposed rule has already i been published and must be concluded or withdrawn before any part of it can be included in another rulemaking action. Furthermore, the language of the , subject proposed rule does not conform with that of the ADM rule and I&E wants l a significantly different retention period from that which was published in l the subject proposed rule. Resolving these issues with a new rulemaking is a l more practicable approach than trying to salvage the subject rulemaking by withdrawing part of it and rewriting another part since, in any case, publishing an amended proposed rule for public coment is required. I i I l 1
l ? William J. Dircks 2 g The user office, I&E, has indicated that the record copying part of this rule is not needed. We have reviewed the rulemaking action and can find no sub-stantive reason to disagree with I&E. Therefore, it is recommended that the rulemaking be terminated. A withdrawal of rulemaking will be prepared and published in the Federal Register. Further, a new rulemaking is recomended to specify the record retention period for physical security records. This new rulemaking will be initiated in conjunction with I&E, 01 and ADM. l I&E, as the original requester for this rulemaking, has concurred in these { recommendations. i kbM M l Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
RES Rulemaking Review l Package for " Copying of Records and Retention Periods for Security Records"
7
*"" UNITED STATES y- 4
, NUCLEAR REGULATORY COMMISSION I
{* WASHINGTON. D. C. 20555
\, ...../
OCT 12 E84 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING Based on our review of the ongoing RES-sponsored rulemaking, " Copying of Records and Retention Periods for Security Records," RES recommends that it be withdrawn in its entirety and a new rulemaking be initiated to specify record retention periods for security records. The results of this independent review endorse my previous findings (attached) and has been coordinated with I&E, the user office. In sumary, the basis for my recommendation is as follows: o RES agrees with I&E that the public comments on the published proposed rulemaking concerning the potential for inadvertent disclosure of proprietary information are valid and that the current practice of licensees routinely providing needed records to the NRC without expense to the Commission is sufficient to protect the health and safety of the public and safeguard special nuclear material, o Since OMB requires that a record retention period be specified for any record that is required by a regulation, a new rulemaking to amend 10 CFR 73.70 to specify record retention periods for security records should be initiated. There are significant changes in format, language, and retention period required; therefore, it must be republished as a proposed rule. The complete RES review package has been sent to OEDO (Attention: DEDROGR) and to the Director, I&E. 1 0. b Robert B. Minogue, Director Office of Nuclear Regulatory Research i i
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#"% UNITED STATES k NUCLEAR REGULATORY COMMISslON I E WASHINGTON. D. C. 20555 5
o, I
\.....*f AUG 3 01964 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
REVIEW BY ED0 OF ONGOING RULEMAKING " COPYING 0F RECORDS AND RETENTION PERIODS FOR SECURITY RECORDS" SPONSORED BY RES 1 As a result of the review of the subject ongoing rulemaking for which RES is the sponsoring office, we recomend tennination of this rulemaking. The inck of explicit authority to copy licensee records was originally identi-fied by I&E as an area of concern which could adversely affect its ability to conduct inspections and investigations. To address this concern, a proposed rule to provide this authority was published for coment in November 1983. This rule also contained an amendment specifying retention periods for safe-guards records. It is current practice for licensees to routinely provide needed records to the NRC without expense to the Comission. Further, most of the public coments received on the proposed rule expressed concern regarding the poten-tial for inadvertent disclosure of proprietary information. Given the history of satisfactory cooperation by the licensees and the increased potential for disclosure of proprietary information that may result from the rule, there is no need, at this time, for a generic resolution on copying of records. The need to specify the retention period for security records still exists. ADM has out for office concurrence a proposed rule, " Retention Periods for Records," whose purpose is to close all remaining open ended recordkeeping requirements in NRC regulations. Simply modifying the ongoing ADM rulemaking for specifying these record retention perieds for physical security records is not possible at this time because the subjert RES proposed rule has already been published and must be concluded or witheawn before any part of it can be included in another rulemaking action. Furthermore, the language of the subject proposed rule does not confonn with that of the ADM rule and I&E wants a significantly different retention period from that which was published in the subject proposed rule. Resolving these issues with a new rulemaking is a more practicable approach than trying to salvage the subject rulemaking by withdrawing part of it and rewriting another part since, in any case, publishing an amended proposed rule for public coment is required. i l i
William J. Dircks 2 AUG 3 o g The user office, I&E, has indicated that the record copying part of this rule is not needed. We have reviewed the rulemaking action and can find no sub-stantive reason to disagree with I&E. Therefore, it is recomended that the rulemaking be terminated. A withdrawal of rulemaking will be prepared and published in the Federal Register. Further, a new rulemaking is recomended to specify the record retention period for physical security records. This new rulemaking will be initiated in conjunction with I&E, 01 and ADM. I&E, as the original requester for this rulemaking, has concurred in these recomendations. Ih M M Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
RES Rulemaking Review Package for " Copying of Records and Retention Periods for Security Records"
c- , A ja "%, UNITED STATES V
+
t NUCLEAR REGULATORY COMMISSION F [. 5
'S WASHINGTON, D. C. 20555 b *
/ JUL 0 61984 N9e \fg
***.* r m
John N. Grace, Director MEMORANDUM FOR:
)
Division of Quality Assurance, Safeguards '# and Inspection Programs, I&E [ FROM: Robert M. Bernero, Director Division of Risk Analysis and Operations, RES
SUBJECT:
DRAFT RECOMMENDATIONS TO ED0 CONCERNING WHETHER AND HOW TO CONTINUE WITH " COPYING 0F RECORDS AND RETENTION PERIODS FOR SECURITY RECORDS" RULEMAKING SPONSORED BY RES Enclosed for your consideration are draft recommendations supported by a draft office review concerning whether and how to continue with " Copying of Records and Retention Periods for Security Records" rulemaking sponsored by RES for which your office is identified as the user office. This memorandum constitutes my concurrence in the enclosed draft recommendations which will be submitted to the Director, RES, within two weeks of the above date. Please acknowledge receipt by returning this memorandum with or without comments on the draft recommendations as indicated below.
/$4A Robert M. Bernero, Director Division of Risk Analysis and Operations, RES
Enclosure:
As stated Receipt knowledged. No Comme Receipt Acknowledged. Comments follow te: 7 / V A John N. Grace, Director '
// Division of Quality Assurance, SafeguardsandInspectionPrograms,I&E t
This package contains the following documents: o Regulatory Agenda Ji o Rulemaking Package as submitted for NRC office concurrence in February,1984 o Recommendations to the EDO o Screening Analysis o Memo dated May 29, 1984 from R. C. DeYoung to R. B. Minogue l l P
Regulatory Agenda TITLE: Authority for the Copying of Records and Retention Periods for Security Records CFR CITATION: 10 CFR 19; 10 CFR 21; 10 CFR 30; 10 CFR 40; 10 CFR 50; 10 CFR 70; 10 CFR 71; 10 CFR 73; 10 CFR 110. ABSTRACT: The purpose of this rule was te define more clearly the authority of an NRC inspector to copy and take away a licensee record that is needed for inspection and enforcement activities. It also specified the period that a licensee physical security record must be maintained. Due to licensee cooperation I&E no longer sees the need for explicit authority to copy and take away records. The rulemaking is therefore being withdrawn. For that portion of the rule which codifies licensee practice for retention of physical security records a new rulemaking will be initiated. TIMETABLE: NPRM 11/22/82 47 FR 52452 NPRM Comment Period Begin 11/22/82 47 FR 52452 NPRM Comment Period End 01/21/83 Final Action to be Determined
2 LEGAL AUTHORITY: 42 USC 2073; 42 USC 2207 EFFECTS ON SMALL BUSINESS AND OTHER ENTITIES: No AGENCY CONTACT Sandra Frattali Office of Nuclear Regulatory Research Washington, DC 20555(301)443-7680
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, 'c- NUCLEAR REGULATORY COMMISSION wasmwovow.o c mss t
MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
RULEMAKING TO PROVIDE SPECIFIC AUTHORITY RELATIVE TO THE COPYING OF LICENSEE RECORDS AND TO SPECIFY RETENTION PERIODS FOR PHYSICAL SECURITY RECORDS The enclosed Commission Paper requests Commission approval to publish final amendments to 10 CFR Parts 19, 21, 30, 40, 50, 70, 71 and 110 authorizing NRC representatives to copy and take away copies of licensee records, and a final amendment to 10 CFR Part 73 specifying retention periods for physical security records. The paper is forwarded for Commission action rather than EDO signa-ture because it includes a minor change to Part 110 and, therefore, is not covered by the authority delegated to the E00. Discussion: The amendments to 10 CFR Parts 19, 21, 30, 40, 50, 70, 71 and 110 address concerns identified by the Office of Inspection and Enforcerrent which affect the NRC's ability to effectively inspect and investigate licensee programs. These concerns relate to specific authority of NRC representatives to make and take away copies of licensee records. The amendment to 10 CFR Part 73 specifies retention periods for physical protection records by codifying staff positions ! and licensee practices, except for security-related maintenance records. The retention period for security-related records is reduced from the current practice of 5 years to 2 years. Specifically, the amendments are as follows: i 1. Parts 19, 21, 30, 40, 50, 70, 71 and 110 are amended to authorize NRC l representatives to make copies of any licensee record kept pursuant to l Commission regulations and remove such copies for Commission use.
- 2. Security records maintained pursuant to 10 CFR Part 73.70 and Appendix B to Part 73 are to be retained for 2 years, with the following exceptions:
- a. Results of initial performance tests for security equipment would be retained for the life of the equipment,
- b. Records of access to locks, keys, combinations and other access control components would be retained for the period that these items are used for security purposes.
l t i
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= J. Dircks .%
On October 19, 1982, the Commission approved a proposed rulemaking providing specific authority for NRC representatives to copy and remove copies of licensee records, and specifying the retention period for licensee physical security records. The proposed rule was published in the Federal Register on November 22, 1982 for a 60-day comment period (47FR52452). Comments were received from 24 respondents.- They have been considered and the amendments revised accordit: gly. A regulatory analysis has been prepared and is provided as an enclosure to the Commission Paper. This final rule is nonsubstative and insignificant from the standpoint of environmental impact. As a result, it is exempt from environmental consider-ation under 10 CFR Part 51.5(d)(1) and (2). Therefore, an environmental impact statement or negative declaration and environmental impact appraisal need not be prepared. A The final amendments do not impose new reporting, recordkeeping or information 4 collection requirements. The record retention periods serve to codify and reduce current record retention guidelines and practice. A copy of the final , amendment will be provided to the Office of Management and Budget for its information. The amendments will not, if promulgated, have a significant economic impact on a substantial number of small entities. Licensees directly affected by the rule changes will be sent copies of the Federal Register notice. A public announcement will not be issued. Appropriate Congressional Committees will be notified by a letter similar to the draft letter included in the Commission Paper. CRGR Review: The final amendments do not impose a significant additional burden on licensees or affect any technical requirements applicable to reactor licensees or applicants. For these reasons, the final amendments are not being submitted for formal CRGR review. A copy of the Commission Paper, with enclosures, is being provided concurrently to the CRGR for their information.
. . - . - - - - --. - ,-.--._,_,- - -_ _ - - - . - , _ - - - ._. _ _ , _ - . . - ~ .
- b. J. Dircks 3 Coordination: The Office of Nuclear Material Safety and Safeguards, the Office of Inspection and inforcement, the Of fice of Nuclear Reactor Regulation, the Of fice of Investigation, the Of fice of Administration, and the Regional Of fices concur in the content of this paper. The Executive Legal Director has no legal objection.
Robert B. Minogue, Du ettor Of fice of Nuclear Regulatory Research
Enclosure:
Commission Paper i l
For: The Commissioners From: Executive Director for Operations
Subject:
RULEMAKING TO PROVIDE SPECIFIC AUTHORITY RELATIVE TO THE COPY-ING OF LICENSEE RECORDS, AND TO SPECIFY RETENTION PERIOD FOR PHYSICAL SECURITY RECORDS
Purpose:
To obtain Commission approval to publish final amendments which clarify the Commission's authority to copy and take away copies of certain licensee records, and specify the retention period for licensee physical security records. Category: Minor policy question requiring Commission approval. Discussion: Background and Proposed Action The lack of specific authority to copy and remove copies of licensee records was originally identified by the Office of Inspection and Enforcement as an area of concern which could adversely affect its ability to properly inspect licensee safeguards programs and conduct investigations under Parts 50 and 70. While paragraphs 50.70(a) and 70.55(a) and (b) require the licensee to allow inspection of both facilities and records, there is no explicit authority for a Commission representative to make and take away copies of licensee records. This has caused delays in obtaining information needed for inspection and enforcement activities and investi-gations. The amendments specifically authorize Commission representatives to copy and take away copies of records required by NRC regulations, orders, or license conditions. During the development of these amendments, it was recognized that this authority should also extend to inspections and investigations of licensee programs other than safeguards. Therefore, for consistency, this authority is also being added to appropriate paragraphs in Parts 19, 21, 30, 40, 71, and 110. ; l
Contact:
Dr. 5. Frattali, RES ; 443-7680 i
The Commissioners 2 Section 73.70 presently requires that a licensee maintain certain physical security records for an unspecified period of time. Staf f guidance, however, has been set forth in
" Interim Acceptance Criteria for a Physical Security Plan for Nuclear Power Plants" (NUREG-0220), " Security Plan Evaluation Report Workbook" (NUREG-0416), and " Security Personnel Train-ing and Qualification Criteria" (NUREG-0674). The guidance indicated that security records should be retained at the site for at least 1 year, with the following exceptions:
(1) Initial performance test results should be maintained for the life of the equipment. (2) Maintenance records should be maintained for a period of 5 years. (3) Individual security training and qualification records should be maintained for a period of 2 years. (4) Records of access to locks, keys, combinations, and other related equipment should be maintained for the period of employment or for the duration that these locks, keys, and combinations are in use. Current power reactor physical protection plans conform to the above staff position. This amendment codifies the staf f position except that the retention period for security-related maintenance records is reduced from 5 years to 2 years. Experience has not indicated that a 5 year retention period is necessary for these documents. On October 19, 1982, the Commission approved a proposed rule-making providing specific authority to copy and remove copies of licensee records, and specifying the retention period for licensee physical security records. The proposed rule was published in the Federal Register on November 22, 1982, for a 60-day comment period (47 FR 52452). Comments were received from 24 respondents. They have been considered and the amend-ments revised accordingly. The substr.ntive comments received on this proposed rulemaking concerned the authority to copy and remove copies of records. Most of the comments expressed concern that specifying such broad authority for NRC representatives might result in inadvertent disclosure of sensitive information (e.g. , pro-prietary information, safeguards information, medical recurds, p esonnel records) into the public domain. The amendments base therefore been revised to provide for the protection of such information in accordance with established NRC procedures. The other amendments included in this paper, concerning reten-
The Commissioners 3 tion periods for physical security records, resulted in no substantive comments, impact of Regulations As discussed above, the amendments serve to provide specific authority to copy records kept pursuant to NRC regulations, orders, or license conditions. In addition, the amendments codify the existing staff position and general licensee prac-tice on security records retention, except that the retention period for security maintenance records is reduced. There-fore, the proposed regulations require no additional resources. Recommendation: That the Commission:
- 1. Approve the amendments (Enclosure A) for publication in the Federal Register.
- 2. Certify, in accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. Section 605(b), that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.
- 3. Note:
- a. That appropriate Congressional Committees will be informed by means of a letter similar to that con-tained in Enclosure C.
- b. That this final rule is nonsubstantive and insigni-ficant from the standpoint of environmental impact.
As a result, it is exempt from environmental con-siderations under 10 CFR 51.5(d)(1) and (2). There-fore, an environmental impact statement or negative declaration and environmental impact appraisal need not be prepared for this rule,
- c. That the regulatory analysis (Enclosure B) will be placed in the Public Document Room,
- d. That a public announcement will not be made.
- e. That these regulations do not impose new reporting, recordkeeping, or information collection require-ments. The amendments serve to codify and reduce existing record retention guidelines and practice.
The amendments will be submitted to the Office of Management and Budget for its information and con-sideration pursuant to the Paperwork Reduction Act of 1980 (Public Law 96-511).
The Commissioners 4
- f. That the ACRS has been informed.
- g. That the Chief Counsel for Advocacy of the Small Business Administration will be informed of the Regulatory Flexibility certification and the reasons for it as required by the Regulatory Flexi-bility Act, 5 U.S.C. Section 605(b).
William J. Dircks Executive Director for Operations
Enclosures:
A - Federal Register Notice B - Regulatory Analysis C - Draft Congressional Letter J
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NUCLEAR REGULA10RY C0m15510N 10 CFF. Parts 19, 21, 30, 40, 50, 70, 71, 73, and 110 Authority for the Copying of Records and Retention Periods for Security Records AGENCY: Nuclear Regulatory Commission. ACTION: Final rule. SumARY: The Nuclear Regulatory Commission is amending its regulations to provide specific authority for NRC representatives to copy licensee records maintained pursuant to Commission requirements and to specify retention periods for required security records. These amendments will result in the avoidance of delays in obtaining information needed for Commission inspection and enforcement activities and investigations, and in the codification of guidance relating to record retention periods. EFFECTIVE DATE: (30 days after publication in the Federal Register). FOR FURTHER INFORMATION CONTACT: Dr. Sandra D. Frattali, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301)443-7680. 1 Enclosure A
[7590-02) SUPPLEMLNTARY INFORMA110N.
Background
The Commission is amending its regulations to provide specific authority for Commission representatives to make and remove copies of licensee records maintained pursuant to Commission requirements and to specify retention periods for existing security records. The lack of specific authority to copy and remove copies of licensee records was originally identified by the Commission as an area of concern which could adversely affect its ability to properly inspect licensee safeguards programs and conduct investigations under Parts 50 and 70. While paragraphs 50.70(a), 70.55(a), and 70.55(b) require a licensee to allow inspection of both facilities and records, there is no explicit authority for a Commission representative to make and take away copies of records. This has caused delays in obtaining information needed for inspection and enforcement activities and investigations. During the development of these amendments it was recognized that this problem could also adversely affect inspections and investigations of licensee programs other than safeguards. Revised paragraphs 19.14(a), 21.41, 30.52(b), 40.62(b), 50.70(a), 70.55(b), 71.63(a)(2), and 110.53(c)(2) will authorize Commission employees to copy, at Commission expense, and remove copies of records maintained pursuant to NRC requirements. The amendments there-fore apply to inspections and investigations of all types of licensee programs. In addition, the Commission is modifying and codifying staff guidance relating to the retention period for physical security records maintained by licensees pursuant to paragraphs 73.30(d), 73.37(b)(10), 73.46(b), 2 Enclosure A
[ :"0-01) 73.50(a), 73.55(b), section 73.70, and paragraph 1.B. of Appendix B to Part 73, The staff guidance, which is currently reflected in approved physical protection and guard training plans, is contained in " Interim Acceptance Criteria for a Physical Security Plan for Nuclear Power Plants" (NUREG-0220), " Security Plan Evaluation Report Workbook" (NUREG-0416), and " Security Personnel Training and Qualification Criteria" (NUREG-0674). The codification is in a renumbered and revised Section 73.70 and requires that physical security records be maintained for two years, except that: (a) results of the initial performance tests for security equipment must be retained for the life of the equipment, and (b) records of access to locks, keys, combinations, and related access control equipment must be maintained for the period that these locks, keys, and combinations are used for physical security purposes. Summary of Public Comments On November 22, 1982, the Nuclear Regulatory Commission published proposed amendments to 10 CFR Parts 19, 21, 30, 40, 50, 70, 71, 73, and 110 in the Federal Register (47 FR 52452). Interested persons were invited to submit written comments and suggestions in connection with the proposed amendments within 60 days after publication in the Federal Register. Comments were received from 24 respondents. The amendments have been modified in response to these comments. Almost all of the commenters expressed concern that, as proposed, the amendments might result in information of a sensitive nature (e.g., proprietary information, safeguards information, personnel records, medical records) being inadvertently disclosed via response to Freedom of Information Act requests or by being placed in NRC Public Document 3 Enclosure A
[7590-01) l Rooms. Several of the commenters recommended that if the authority to copy such records is to be specifically given to NRC representatives, provi-sions should be included that either the representative must establish a need to know or that some method of exempting certain records from the copying provisions should be established. These comments f ail to recog-nize two points: these records are exempt from disclosure under 10 CFR Parts 2 and 9; and NRC inspectors and investigators already have the authority to copy licensee records. These amendments are intended to clarify that authority, not to establish any new authority. In response to these concerns, however, the final rule has been revised to emphasize that the records copied by an NRC representative during an inspection or investigation will be withheld from disclosure in accordance with estab-lished agency practice under 10 CFR Parts 2 and 9. In response to comments from two respondents, consideration was given to requiring the NRC to provide the licensee with a list of records taken. Because this procedure would interfere with NRC investigative activities by possibly giving an indication of the direction of the investigation, this suggestion has not been incorporated in the final rule. Three commenters objected to the term "a representative of the Commission" on the basis that the term was undefined and could presumably include consultants or NRC contractor employees who would thereby have access to too broad a range of information. Consideration was given to using the term "an employee of the Commission" in lieu of " representative." However, several NRC Regional Offices are considering contracting out certain aspects of their inspection programs. In addition, the investi-gation program has been using non-NRC employees to assist in the investi-gations. These personnel are trained and provided with appropriate 4 Enclosure A
[7590 01) credentials authorizing access to licensee facilities and records. How-ever, they are not considered employees of the NRC. Therefore, the final rule has been revised to use the term "a duly authorized representative of the Commissicn." Four commenters expressed concern that specifying unrestricted authority to copy and take away information would result in less ef f ec-tive inspections. This was based on the idea that, given this authority, inspectors might use it to take copies of everything and conduct " paper" inspections in their own offices rather than at the licensee site. Another concern expressed was that information could more easily be taken out of context, resulting in inaccuracies in the inspection reports. The Commission recognizes that the quality of its inspections and investigations is heavily reliant on the information collected in the course of onsite interaction and cooperation between the NRC and the licensee. There is no intent of allowing NRC representatives to use these provisions to conduct " paper" inspections or investigations. The intent of the provisions is to improve the inspections and investigations by (1) allowing the inspector or investigator to use all of the onsite time available for conducting the inspection or investigation, rather than copy-ing information by hand; (2) allowing the inspector or investigator to have complete, accurate information on which to base the report, rather than just partial information; and (3) in the rare instance that a gees-tion comes up, providing a specific reference so that no time is wasted in determining whether or not the authority to copy the record (s) exists. 5 Enclosure A
[75% i.) No invironmental Impact This final rule is nonsubstantive and insignificant from the stand-point of environmental impact. As a result, it is exempt f rom environ-mental considerations under 10 CFR 51.5(d)(1) and (2). Therefore, an environmental impact statement or negative declaration and environmental impact appraisal need not be prepared for this rule. PAPERWORK REDUCTION ACT STATEMENT This final rule does not contain a new or amended information collec-tion requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget Approval Number 3150-0002. REGULATORY ANALYSIS The Commission has prepared a regulatory analysis on this final regu-lation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The analysis is available for inspection in the NRC Public Document Room,1717 H Street NW. , Washington, DC. Single copies of the analysis may be obtained from Dr. Sandra D. Frattali, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301)443-7680. REGULATORY FLEXIBILITY CERTIFICATION In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this rule does not have a significant 6 Enclosure A
[7590-01) economic impact on a substantial number of small entities. Any increased costs incurred in order to copy and take away copies of certain licensee records will be borne by the NRC and not the licen.*,ee. Industry will benefit from codification of the modified records retention requirement. By reducing the retention period for security maintenance records from five years to two years, and based on estimated storage costs of $210 per cubic foot per year, an estimated savings of $11,340 per year should result for each licensee. LIST OF SUBJECTS IN 10 CFR Part 73 Hazardous materials-transportation, Nuclear materials, Nuclear power plants and reactors, Penalty, Reporting requirements, Security measures. Under the Atomic Energy Act of 1954, as amended, the Energy Reorgani-zation Act of 1974, as amended, and 5 U.S.C. 552 and 553, the following amendments to 10 CFR Parts 19, 21, 30, 40, 50, 70, 71, 73, and 110 are published as a document subject to codification. The authority citation for this document is Sec. 161, Pub. L. 83-703, 68 Stat. 948, as amended (42 U.S.C. 2201) and sec. 201, Pub. L. 93-438, 88 Stat. 1242 (42 U.S.C. 5841). PART 19 - NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS
- 1. Paragraph (a) of S 19.14 is revised to read as follows:
S 19.14 Presence of representatives of licensees and workers during inspections. 7 Enclosure A
[ 7 b90- Ol j (a) Each licensee shall af ford to the Comrission at all reasonable times, opportunity to inspect materials, activities, facilities, premises, and records pursuant to the regulations in this chapter. A duly authorized representative of the Commission may copy, at Commission expense, any record kept pursuant to the regulations in this part, Commission order, or license condition, and take possession of and remove such copies for Commission use. These records must be withheld from public disclosure in accordance with established Commission procedures. A A A A A PART 21 - REPORTING OF DEFECTS AND NONCOMPLIANCE
- 2. Section 21.41 is revised to read as follows:
6 21.41 Inspections. Each individual, corporation, partnership or other entity subject to the regulations in this part shall permit duly authorized representa-tives of the Commission to inspect its records, premises, activities, and basic components as necessary to effectuate the purposes of this part. A duly authorized representative of the Commission may copy, at Commission expense, any record kept pursuant to the regulations in this part and take possession of and remove such copies for Commission use. These records must be withheld from public disclosure in accordance with established Commission procedures. r 8 . Enclosure A
~
[7590-03) PAR 130 - RULES OF GENERAL APPLICABIL11Y 10 DOMESilC LICENSING OF BYPRODUC1 MATERIAL
- 3. Paragraph (b) of 5 30.52 is revised to read as follows:
5 30.52 Inspections. A A A A A (b) Each licensee shall make available to the Commission for inspection, upon reasonable notice, records maintained pursuant to the regulations in this chapter. A duly authorized representative of the Commission may copy, at Commission expense, any record kept pursuant to the regulations in this part, Commission order, or license condition, and take possession of and remove such copies for Commission use. These records must be withheld from public disclosure in accordance with estab-lished Commission procedures. PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL
- 4. Paragraph (b) of 6 40.62 is revised to read as follows:
- 6 40.62 Inspections.
!
- A A A A (b) Each licensee shall make available to Commission for inspection, upon reasonable notice, records maintained pursuant to the regulations in this chapter. A duly authorized representative of the Commission may o
l copy, at Commission' expense, any record kept pursuant to the regulations ( in this part, Commission order, or license condition, and taxe possession l of and remove such copies for Commission use. These records must be with-i 9 Enclosure A
[759D-01, held from public disclosure in accordance with established Commission procedures. PART 50 - DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES
- 5. Paragraph (a) of 5 50.70 is revised to read as follows:
5 50.70 Inspections. (a) Each licensee and each holder of a construction permit shall permit inspection, by duly authorized representatives of the Commission, of its records, premises, activities, and of licensed materials in posses-sion or use, related to the license or construction permit as may be necessary to effectuate the purposes of the Act, including section 105 of the Act. A duly authorized representative of the Commission may copy, at . Commission expense, any record kept pursuant to the regulations in this part, Commission order, or license condition, and take possession of and remove such copies for Commission use. These records must be withheld from public disclosure in accordance with established Commission procedures.
* * *
- a PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL
- 6. Paragraph (b) of 9 70.55 is revised to read as follows:
$ 70.55 Inspections.
(b) Each licensee shall make available to the Commission for inspec-tion, upon reasonable notice, records kept by the licensee pertaining to 10 Enclosure A
[7590-03) its receipt, possession, use, acquisition, import, export, or transfer of special nuclear material. A duly authorized representative of the Commission may copy, at Commission expense, any record kept pursuant to the regulations in this part, Commission order, or license condition, and take possession of and remove such copies for Commission use. These records must be withheld from public disclosure in accordance with estab-lished Commission procedures. PART 71 - PACKAGING OF RADIDACTIVE MATERIAL FOR TRANSPORT AND TRANSPORTATION OF RADI0 ACTIVE MATERIAL UNDER CERTAIN CONDITIONS
- 7. Paragraph (a) of S 71.63 is revised to read as follows:
S 71.63 Inspections and tests. (a) The licensee shall permit the Commission at all reasonable times to inspect the licensed raterial, packaging, and premises and facilities in which the licensed material or packaging are used, produced, tested, stored or shipped. A duly authorized representative of the Commission may copy, at Commission expense, any record kept pursuant to the regula-tions in this part, Commission order, or license condition, and take possession of and remove such copies for Commission use. These records must be withheld from public disclosure in accordance with established Commission procedures. 11 Enclosure A
[ 7 te. - D1] PAR 173 - PHYS] CAL PR01[C110N OF PLAN 15 AND MATERIALS
- 8. Section 73.70 is revised to read as follows:
$ 73.70 Records (a) Each licensee subject to the provisions of SS 73.20, 73.25, 73.26, 73.27, 73.45, 73.46, 73.55, or 73.60 shall keep the following records:
(1) Names and addresses of all individuals who have been designated as authorized individuals. (2) Names, addresses, and badge numbers of all individuals authorized to have access to vital equipment or special nuclear material, and the vital areas and material access areas to which authorization is granted. (3) A register of visitors, vendors, and other individuals not employed by the licensee pursuant to $$ 73.46(d)(10), 73.55(d)(6), or 73.60. (4) A log indicating name, badge number, time of entry, reason for entry, and time of exit of all individuals granted access to a ncrmally unoccupied vital area. (5) Documentation of all routine security tours and inspections, and of all tests, inspections, and maintenance performed on physical barriers, intrusion alarms, communications equipment, and other security-related equipment used pursuant to the requirements of this part. (6) A record at each onsite alarm annunciation location of each alarm, false alarm, alarm check, and tamper indication that identifies the type of alarm, location, alarm circuit, date, and time. l l l 12 Enclosure A
[7590-01] In addition, details of response by f acility guards and watchmen to each alarm, intrusion, or other security incident must be recorded. (7) Shipments of special nuclear material subject to the require-ments of this part, including names of carriers, major roads to be used, flight numbers in the case of air shipments, dates and expected times of departure and arrival of shipments, verification of communication equip-ment on board the transfer vehicle, names of individuals who are to communicate with the transport vehicle, container seal descriptions and identification, and any other information to confirm the means utilized to comply with $$ 73.25, 73.26, and 73.27. This information must be recorded prior to shipment. Information obtained during the course of the shipment such as reports of all communications, change of shipping plan, including monitor changes, trace investigations and other informa-tion, must also be recorded. (8) Procedures for controlling access to protected areas and for controlling access to keys for locks used to protect special nuclear material. (b) The licensee must maintain records subject to the requirements of this part at the licensee's site for the following periods: (1) Results of initial performance tests for security equipment must be maintained for the life of the equipment. (2) Records that certify accomplishment of security training and qualification requirements, including test scores, must be maintained for two years. 13 Enclosure A
, J . i ;)
(3) Records of access to locks, keys, combinations, and other access control components must be maintained for the period that these locks, keys, combinations, and related components are used f or security purposes. (4) Other records required by this section must be maintained for two years. PART 110 - EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL
- 10. Paragraph (c) of 5 110.53 is revised to read as follows:
6 110.53 United States address, records and inspections. a a a m n (c) Each licensee shall permit the Commission to inspect its records, premises, and activities pertaining to exports and imports when necessary to fulfill the requirements of the Atomic Energy Act. A duly authorized representative of the Commission may copy, at Commission expense, any record kept pursuant to the regulations in this part, Commission order, or license condition, and take possession of and remove such copies for Commission use. These records must be withheld from public disclosure in accordance with established Commission procedures. Dated at Washington, DC, this day of , 1984. For the Nuclear Regulatory Commission. Samuel J. Chilk, Secretary of the Commission. 14 Enclosure A
I REGULATORY ANALYSIS
- 10 CFR PARTS 19, 21, 30, 40, 50, 70, 71, 73, and 110 AUTHORITY FOR THE COPYING OF RECORDS AND RETENTION PERIODS FOR SECURITY RECORDS
- 1. Statement of the Problem The Office of Inspection and Enforcement has identified an area of con-cern which could adversely affect its ability to properly inspect licensee safeguards programs and conduct investigations.
While paragraphs 50.70(a), 70.55(a), and 70.55(b) require the licensee to allow inspection of both facilities and records, there is no explicit authority , for a Commission representative to make and remove copies of records. This has caused delays in obtaining information needed for inspection and enforcement activities and investigations. The amendment specifically authorizes Commis-sion representatives to copy, take possession of and remove copies of records required by NRC regulations, orders, or licensee conditions. This authority is being added to appropriate paragraphs of Parts 19, 21, 30, 40, 50, 70, 71, and 110. Section 73.70 presently requires that a licensee maintain certain physi-cal security records for an unspecified period of time. Staff guidance, how-ever, has been set forth in " Interim Acceptance Criteria for a Physical Secu-rity Plan for Nuclear Power Plants" (NUREG-0220), " Security Plan Evaluation Report Workbook" (NUREG-0416), and " Security Personnel Training and Qualifi-cation Criteria" (NUREG-0674). The guidance indicated that security records "A value/ impact statement was prepared and placed in the Public Document Room when these amendments were published in proposed form for public comment (47 FR 52452) The content of the value/ impact statement has been modified somewhat and reformatted as a regulatory analysis, in order to comply with a revision in NRC rulemaking procedures. The regulatory analysis is available in the NRC Public Document Room, 1717 H Street NW., Washington DC. 1 Enclosure B
should be retained at the site for at least 1 year, with the following exceptions: (1) lnitial performance test results shall be maintained for the life of the equipment. (2) Maintenance records shall be maintained for a period of 5 years. (3) Individual security training and qualification records shall be main-tained for a period of 2 years. (4) Records of access to locks, keys, combinations, and other related equipment shall be maintained for the period of employment or for the duration that such locks, keys, and combinations are in use. Current power reactor physical protection plans conform to the above staff position. The final amendment included in this action would codify the staf f position except that the retention period for security-related maintenance records would be reduced from 5 years to 2 years. Although a 1 year retention period was indicated by the staff guidance, a 2 year period is being used in these amendments for consistency with standard NRC retention schedules.
- 2. Objective The objective of these amendments is to improve the ability of the NRC to properly inspect licensee safeguards programs and conduct investigations, by clarifying the inspectors' and investigators' authority to copy licensee records. The amendments specifying retention periods for security records are merely codifying current licensee practice.
- 3. Alternatives The alternatives considered for each of the actions being taken were as follows:
2 Enclosure B
T~ 3.1 Authority to Copy Records 3.1.1 Maintain the status quo Without the specific authority to copy and take away copies of licensee records, the NRC inspectors and investigators have been placed in the position of either copying the information they need for their inspections by hand, or obtaining the information by written request af ter completing the onsite por-tion of their inspection. This adversely affects the ability of the NRC to ef ficiently and effectively inspect licensee safeguards programs and conduct investigations. 3.1.2 Provide specific authority to copy records only in Part 21 Although this alternative would provide the necessary authority, it would tie the authority to situations where the inspector believes the public health and safety is in imminent danger; it would not clearly apply in a routine inspection situation. 3.1.3 Amend Parts 19, 21, 30, 40, 50, 70, 71, and 110 This alternative clearly gives the inspectors and investigators the authority to copy and take away copies of licensee records in a routine inspec-tion situation. 3.2 Retention Periods for Security Records 3.2.1 Maintain the status quo The status quo requires that licensees retain physical protection records to meet regulatory objectives. Continued reliance on staf f positions causes licensees to maintain some records longer than necessary resulting in an ! unnecessary burden which would not be consistent with the Paperwork Reduction Act of 1980 and Commission policy. I i 3 Enclosure B
3.2.2 Codifying prPsent licensee practice ; The appropriate means of complying with the Paperwork Reduction Act of 1980 and Commission policy regarding records retention is to amend the Commis- , sion's regulations to codify what is already being done by the licensees.
- 4. Consequences The amendments relating to copying of records are expected to result in more efficient use, and in some instances, a reduction of inspector and investi-gator time spent onsite. The NRC costs associated with photocopying needed licensee records will be more than offset by the savings in inspector hours (at
?60 per hour) which would otherwise be required to manually copy information from licensee records. Photocopy machines are already in place within NRC Resident Inspector offices; therefore, no additional equipment purchases are required. Although Parts 19, 21, 30, 40, 50, 70, 71, and 110 are all being amended for_ consistency, it is expected that the most frequent use of this authority will be made during inspections or investigations of Part 50 and Part 70 licensees. It is also expected that the authority will only be used on an infrequent basis. With proper handling by the NRC of any sensitive information that is copied, the licensees should not experience any impact.
Industry will benefit from codification of the modified staff position relating to records retention. It is estimated that security maintenance records are accumulated at the rate of 1.5 cubic feet per month, or 18 cubic feet per year. By reducing the retention period for these records from 5 years to 2 years, and based on estimated storage costs of $210 per cubic foot per < year, an estimated savings of $11,340 per year should result for each licensee. No other impact on industry has been identified. No impact on other government agencies has been identified. [ 4 Enclosure B
- 5. Decision Rationale The actions will increase the efficiency of NRC inspector and investigator time onsite and reduce the record retention burden on licensees without sub-stantial additional cost or reduced public protection. Other alternatives were rejected because they did not fully accomplish the objectives. The amendments serve to remove areas of concern from the regulations which may impede an effec-tive and efficient inspection and enforcement and investigation program. The records retention period codifies a modified staff position, and is expected to meet regulatory needs while reducing licensee storage costs by approximately
$11,000 per year per site.
1 i l 5 Enclosure B
l DRAFl CONGRESSIONAL LETTER 1 l
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of a Federal Register Notice which was approved by the Commission on , 1984. The Nuclear Regulatory Commission (NRC) is amending its regulations to provide specific authority to copy and take away copies of records maintained pursuant to NRC requirements, and specify retention periods for licensee physical security records. Although licensees are required to allow inspection of both facilities and records, there is no explicit authority for Commission representatives to make and take away copies of licensee records. This amendment provides that authority. The record retention periods serve to codify present licensee practice, except for security equipment maintenance records. The retention period for this class of records would be reduced from the current five years to two years. Sincerely, Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
Federal Register Notice 1 Enclosure C
r RECOMMENDATIONS TO THE ED0 FOR CONTINUED RULEMAKING
" AUTHORITY FOR THE COPYING OF RECORDS AND RECORD RETENTION PERIODS FOR SECURITY RECORDS" 'pckground The rule addresses two issues, NRC authority to copy licensee records and security record retention periods. The lack of explicit authority to copy licensee records was originally identified by the Office of Inspection and Enforcement as an area of concern which could adversely affect its ability to conduct inspections and investigations. A proposed rule was published for comment on November 22, 1983 in 47 FR52452. This rule also contained an amend-ment specifying retention periods for safeguards records. The public comments received which opposed the rule did so primarily because of issues relating to the potential for inadvertent disclosure of sensitive information such as proprietary information, personnel records, etc. via F0IA requests or through being placed in the PDR.
Status I&E reconsidered their position and decided there was no longer a need for explicit authority to copy records. They requested that the rule be withdrawn since it could cause an unnecessary administrative burden and licensees are routinely providing needed records to the NRC inspectors and investigators without expense to the Commission. Further, most of the public comments raised the issue of protection of proprietary information. I&E indicates that in the face of the potential difficulty in solving this problem and given the history of cooperation by the licensees there is no need for a generic resolution of this issue at this time.
2 However, the rule also specifies a retention period for security records required by 10 CFR 73.70. In the memo requesting termination of the rule-making, I&E indicates that this part is included in another proposed rule-making, the ADM rule to close record retention periods. This is not the case. Since the RES rule was published in proposed form, it must be either concluded or withdrawn before another rulemaking covering the same subject action can be initiated. Further, the RES and the ADM version differ in language and format. In addition while both versions propose a two year retention period and I&E concurred with this period when the RES proposed rule was published, IE reconsidered their position and did not concur in the RES final rule. Instead, they requested a 5 year retention period for all records required by 10 CFR 73.70. The record retention issue still needs to be addressed by a rulemaking action. Simply changing the retention period from 2 years to 5 years in the current rule and publishing only that part is not possible. It would be necessary to publish the rulemaking again as a proposed rule because requiring a 5 year retention period is a significant change from requiring a 2 year retention period. Recorrmendations We have reviewed this rulemaking and can find no substantive reason for not complying with the user (I&E) request for terminating the action. Therefore, it is recommended that this rulemaking action be terminated. A new proposed
3
. rule to close the record retention period of 10 CFR 73.70 should be initiated.
Its language and format would be similar to that of the proposed ADM rule and we recorinend that, if practicable, it be included in the ADM rule when that rule goes final. The record retention period required would be 5 years provided that the user office, I&E, justifies the need for the longer period. 1 3 T e. i i
, , ~ . . . - . - . ._-, . . . - , , , . . _ - . , , - - , . - - . , . , .
r SCREENING ANALYSIS AUTHORITY FOR THE COPYING 0F RECORDS AND RECORD RETENTION PERIODS FOR SECURITY RECORDS
- 1. The issue to be addressed, i.e., the problem to be corrected.
- o. Authorize NRC employees to copy and take away copies of licensee records. I&E indicates this is no longer a problem. ,
o Specifying retention periods for physical security records.
- 2. The necessity and urgency for addressing the issue.
o The lack of specific authority to copy and remove copies of licensee records was identified by I&E and 01 as an area of concern which could adversely affect their ability to properly inspect licensees. However, since licensees routinely provide records to the NRC, I&E has has reconsidered their. position and feel this authority is not neces-sa ry, o 0MB requires that if a record is required by a regulation, a record retention period be specified. The physical security record require-ments of 10 CFR 73.70 lack such a specified retention period. ;
- 3. Alternatives to rulemaking, o Maintain the status quo. This is satisfactory for copying records but there is still an open ended record retention period to consider.
The NRC does not meet requirements of OMB regulation 5 CFR 1320.6.
- 4. How the issues will be addressed through rulemaking, o The amendments to 10 CFR Parts 19, 21, 30,40, 50, 70, 71 and 110 giving explicit authority for NRC employees to copy and remove copies ;
of records are not needed and will be withdrawn. 1 o The amendment to 10 CFR 73.70 to specify record retention periods for physical security records will also be withdrawn. A nes-proposed rulemaking will be initiated. Justification for longer record retention period will be provided by I&E. ,
2
- 5. How the public, industry, and NRC will be affected as a result of rulemaking, including benefits and costs, occupational exposure, and resources.
o The withdrawal of the current rulemaking will have no impact. o The record retention periods required in the current proposed rulemaking are generally less than current licensee practices resulting in a lesser burden on the licensee, however, the longer record retention period requirement in the new proposed rulemaking will result in additional burden on the licensee.
- 6. NRC resources and scheduling for withdrawing the rulemaking.
o - Contractual Funds Required - none Professional Staff Months - 2 months NPRM to be Determined
A .
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l MEMORANDUM FOR: Robert Minogue Director Office of Nuclear Regulttary Research FROM: Richard C. DeYoung, Director Office of Inspection and Enforcement
SUBJECT:
RULEMAKING ON COPYING OF RECORDS AND RETENTION PERIODS FOR SECURITY RECORDS As a result of difficulty some time ago in obtaining copies of licensee records, a rulemaking was initiated at the request of this office. A proposed rule was published for coment on November 22, 1983 in 47 FR 52452. Many of the commen-tors are opposed to the rule primarily because of issues related to protection of proprietary information. Following reconsideration of the rule I was concerned with the provision related to copying records at NRC expense. This could create an unnecessary adminis-trative burden since licensees are routinely providing records to NRC inspectors and investigators without Comission expense. I elaborated on this matter in my memorandum to Karl Goller on March 23, 1984. In those instances where difficulty has been encountered, discussions between appropriate NRC and licensee officials have promptly resolved the issue. Thus, at this time there does not appear to be a need for a generic resolution of the matter, especially in the face of the difficult proprietary protection issues. Therefore, I recomend that the rulemaking be tenninated. I still, of course, believe that copies of records are at times necessary to perform our responsi-bilities. However, given the general cooperation of licensees and the effort needed to resolve the outstanding rulemaking issues, it appears more appropriate to handle any dispute on a case by case basis. The notice terminating the rule-making should make it clear that we are prepared to initiate appropriate enforcement action in accordance with Subpart B of 10 CFR 2 to obtain records necessary to carry out the agency's responsibilities. i, 841220
3 l l Robert Minogue j l l The rulemaking also addressed the issue of retention times for certain records. l This issue is the subject of another ongoing rulemaking so that it need not be pursued as part of the subject rulemaking. Should you have any further questions on this matter, please call me. O Richard . D Young!) Director Office o spection and Enforcement cc: H. R. Denton, NRR J. G. Davis, NMSS B. B. Hayes, 01 G. H. Cunningham, ELD
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; WS MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RUI.EMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING, " CODIFYING INVENTORY REPORTING REQUIREMENTS" Based on our review of the ongoing RES sponsored rulemaking, " Codifying Inventory Reporting Requirements," RES recomends that it be continued. The results of this independent review endorse my previous findings (attached) and have been coordinated with I&E, the original requesting office and NMSS, the licensing office. In sumary, the basis for my recommendation is as follows: " o The current material control and accounting regulations for fuel facilities require the performance of physcial inventories of special nuclear material (SNM) by licensees on a periodic basis. Current regulations do not require these licensees to submit the results to the NRC unless certain specified thresholds are exceeded. However, this information is used by NRC to determine compliance with regulations, evaluate licensing performance, and to provide data for NUREG-0430, Licensed Fuel Facilities Status Report / Inventory Difference Data. This document which reports licensed fuel facilities physical inventory difference data following agency review-of the information and completion of any related investigations was - initiated in response to congressional and public concerns by the Director of ISE in 1977. Coincident with the first publication of this document, a briefing was held with representatives from the governors' offices of the involved states, NRC and DOE (D0E published a companion report). At this briefing, the NRC representative presented tha first issue of NUREG-0430, . and made a commitment to continue the publication of this document semiannually. o To help meet the above needs, I&E instituted in 1975 a voluntary reporting system known as the Safeguards Status Report System (SSRS). Currently fourteen licensees voluntarily provide verbal reports, with a written follow-up, of the results of physical inventories to the appropriate i regional office. I&E has requested and RES agrees that there should be an explicit regulatory basis for this reporting system. Futhermore, the i
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-W. J. Dircks 2 OCT 2 2 y Paperwork Reduction Act of 1980 requires agencies making an information request of 10 or more persons to obtain OMB approval for the request and for any form used to collect the information. This voluntary reporting
- system was started prior to the Act and clearance has never been obtained from OMB for this reporting of physical inventory information by licensees.
Thus, an additional objective of this rulemaking is to obtain OMB approval for the information collection, o Since the SNM physical inventory information is needed by NRC/I&E and the proposed rulemaking would codify existing practice with little or no impact on licensees, the NRC, or the )ublic, it is recommended that the rulemaking be continued. A package for t1e proposed rulemaking will be prepared by RES and published in the Federal Register. An OMB package will also be prepared by RES to satisfy the information collection requirements. The complete RES review package has been sent to OED0 (Attention DEDROGR) and to the Director, I&E. k< i h. Robert B. Minogue, Di r Office of Nuclear Regulatory Research o
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MEMORANDUM FOR: William J. Dircks
] Executive Director for Operations ! FROM: Robert B. Minogue, Director } Office of Nuclear Regulatory Research 1
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SUBJECT:
CONTROL 0F NRC RULEMAKING: RES REVIEW 0F ONG0ING
, RES SPONSORED RULEMAKING, " CODIFYING INVENTORY REPORTING REQUIREMENTS" Based on our review of the ongoing RES sponsored rulemaking, " Codifying Inventory Reporting Requirements," RES recomends that it be continued. The , results of this independent review endorse my previous findings (attached) and have been coordinated with I&E, the original requesting office and NMSS, the licensing office.
In sumary, the basis for my recomendation is as follows: o The current material control and accounting regulations for fuel facilities require the performance of physcial inventories of special nuclear material (SNM) by licensees on a periodic basis. Current regulations do not require these licensees to submit the results to the NRC unless certain specified I thresholds are exceeded. However, this information is used by NRC to I determine compliance with regulations, evaluate licensing performance, and j to provide data for NUREG-0430, Licensed Fuel Facilities Status i Report / Inventory Difference Data. This document which reports licensed I fuel facilities physical inventory difference data following agency review { of the information and completion of any related investigations was 5 initiated in response to congressional and public concerns by the Director i of I&E in 1977. Coincident with the first publication of this document, a briefing was held with representatives from the governors' offices of the , involved states, NRC and DOE (DOE published a companion report). At this briefing, the NRC representative presented the first issue of NUREG-0430, and made a comitment to continue the publication of this document semiannually. o To help meet the above needs, I&E instituted in 1975 a voluntary reporting system known as the Safeguards Status Report System (SSRS). Currently fourteen licensees voluntarily provide verbal reports, with a written follow-up, of the results of physical inventories to the appropriate regional office. I&E has request 3 and RES agrees that there should be an explicit regulatory basis for this reporting system. Futhermore, the i
W. J. Dircks 2 OCT 2 2 gg4 Paperwork Reduction Act of 1980 requires agencies making an information request of 10 or more persons to obtain OMB approval for the request and for any form used to collect the information. This voluntary reporting system was started prior to the Act and clearance has never been obtained from OMB for this reporting of physical inventory information by licensees. Thus, an additional objective of this rulemaking is to obtain OMB approval for the information collection, o Since the SNM physical inventory information is needed by NRC/I&E and the proposed rulemaking would codify existing practice with little or no impact on licensees, the NRC, or the public, it is recommended that the ruleuaking be continued. A package for the proposed rulemaking will be prepared by RES and published in the Federal Register. An OMB package will also be prepared by RES to satisfy the information collection requirements. The complete RES review package has been sent to OED0 (Attention DEDR0GR) and to the Director, I&E. h. Robert B. Minogue, Di ector Office of Nuclear Regulatory Research 4 i l l 1
t . OCT 2 2 gg MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONGOING RES SPONSORED RULENAKING, " CODIFYING INVENTORY REPORTING REQUIRD1ENTS" Based on our review of the ongoing RES sponsored rulemaking, " Codifying Inventory Reporting Requirements," RES recomends that it be continued. The results of this independent review endorse my previous findings (attached) and have been coordinated with I&E, the original requesting office and NHSS, the licensing office. In sumary, the basis for my recomendation is as follows: o The current material control and accounting regulations for fuel facilities require the performance of physcial inventories of special nuclear material (SNM) by licensees on a periodic basis. Current regulations do not require these licensees to submit the results to the NRC unless certain specified thresholds are exceeded. However, this information is used by NRC to determine compliance with regulations, evaluate licensing performance, and to provide data for NUREG-0430, Licensed Fuel Facilities Status Report / Inventory Difference Data. This document which reports licensed fuel facilities physical inventory difference data following agency review of the information and completion of any related investigations was initiated in response to congressional and public concerns by the Director of I&E in 1977. Coincident with the first publication of this docu:nent, a briefing was held with representatives from the governors' offices of the involved states, NRC and DOE (DOE published a companion report). At this briefing, the NRC representative presented the first issue of NUREG-0430, and made a comitment to continue the publication of this document semiannually. o To help meet the above needs, I&E instituted in 1975 a voluntary reporting system known as the Safeguards Status Report System (SSRS). Currently fourteen licensees voluntarily provide verbal reports, with a written follow-up, of the results of physical inventories to the appropriate regional office. I&E has requested and RES agrees that there should be an explicit regulatory basis for this reporting system. Futhermore, the
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W. J. Dircks 2 OCT 2 21984 Paperwcrk Reduction Act of 1980 requires agencies making an information request of 10 or raore persons to obtain 0;;5 approval for the request and for any fora used to collect the information. Tnis voluntary reporting systen was started prior to the Act and clearance has never been obtained frou OMS for this reporting of pnysical inventory information by licensees. Tnus, ai, additional objective of this rulenaking is to obtain O!iB approval for the inforuation collection. o Since the S!C physical inventory information is needed by NRC/I&E and the proposed rulenaking would codify existing practice with little or no inpact i on licensees, the liRC, or the public, it is recomended that the rulemaking l bc continued. A package for the proposed rulenaking will be prepared by i RES and published in the Federal Register. An OMB package will also be prepared by RES to satisfy the information collection requirements. The complete RES review package has been sent to OEDO (Attention DEDROGR) and to the Director, I&E.
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RES REVIEW PACKAGE D. i. .. iu . -. b . . ~~ a a 4- * - + - --- - -
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r MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
REVIEW BY EDO 0F ONGOING RULEMAKING " CODIFYING INVENTORY REPORTING REQUIREMENTS" SPONSORED BY RES As the result of our review of the subject ongoing rulemaking for which RES is the sponsoring office, we reconnend continuatioiy of the rulemaking. The current material control and accounting regulations for fuel facilities require the perfonnance of physical inventories of special nuclear material (SNM) by licensees on a periodic basis. Current regulations do not require these licensees to submit the results to the NRC unless certain specified e threshholds are exceeded. However, this information is needed by MRC to determine compliance with the regulations and to provide data for NUREG-0430, Licensed Fuel Facilities Status Report / Inventory Difference Data. Currently fourteen affected licensees make a voluntary commitment as part of their operating plan to report verbally, with a written follow up, results of physical
- inventories to the appropriate regional office. If they did not do so voluntarily, NRC would have to conduct additional inspections to acquire the i
needed infomation. NRC could continue to rely on each individaul licensee to voluntarily provide this needed infomation. However, the need for this type of information is generic to all such facilities including any facilities of this i type that may be licensed in the future. Rulemaking is the prefered method for resolving such generic issues. Futhermore, the Papenvork Reduction Act of 1980 ) requires agencies making infonnation requests of 10 or more persons to obtain OMB approval for the request and for any form used to collect the infomation. Since clearance has never been obtained from OMB for this reporting of I physical inver.cory information by licensees, an additional objective of this rulanaking is to provide a regulatory basis for this practice and to obtain OMB approval for the information collection. Since the SNM physical inventory information is needed by NRC/I&E and the proposed rulemaking would codify existing practice with little or no impact on licensees, the NRC or the public, it is recommended that the rulemaking be continued. A package for the proposed rulemaking will be prepared and published in the Federal Register. An OMB package will also be prepared by RES to satisfy the information collection requirements. I f~ i I l
DISTRIBUTION: RMinogua Dross FGillespie JNorberg MErnst PTing ISE as the original requester for the rulemaking has concurred in th1SFrattali reconsnendation. SFrattali/rdg HFSG/subj HFGS/rdg Robert B. Minague Director Office of Nuclear Regulatory Research
Enclosure:
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William J. Dircks 2 I&E, as the original requester for the rulemaking, and NMSS, as the licensing office have concurred in this recc:nnendation. Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
RES Rulemaking Review Package for " Codifying Inventory Reporting Requirements" DISTRIBUTION: RMinogue Dross FGillespie JNorberg MErnst PTing SFrattali SFrattali/rdg HFSG/subj HFGS/rdg JGrace, I&E RFBurnett, SG,NMSS CKNulsen, SGMT, NMSS WBBrown, SGFF, NMSS W DD G:NMSS D/ AS&IP/I&E R.Burnett J. Grace CSEE PREVIOUS CONCURRENCE $/gl/84 n 9/z484 cmcc) *RE,S,h0,(HFjiB,,*RES/,D,$Q/,Hf,SE..*RE.S/.0RAQs lif
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This package contains the following documents: o Regulatory Agenda o Proposed Amendment to 10 CFR 70.53(c) o Recommendations to the ED0 o Screening Analysis o 3 Supporting Documents:
- 1) Memo dated May 16, 1984 from L.I. Cobb to J.A. Norberg
- 2) Memo dated March 30, 1984 from L.I. Cobb to E.F. Fox
- 3) Memo dated June 2,1982 from R.C. DeYoung to R.B. Minogue
3 DRAFT REGULATORY AGENDA ENTRY
NRC REGULATORY AGENDA TITLE: Material Status Reports 4 CFR CITATION: 10 CFR 70 4 ABSTRACT: The NRC is amending its regulations in 70.53 to require affected licensees to report data summarizing the results of physical inventories of special nuclear material (SNM). The affected licensees are required by 70.51 to conduct the physical inventories but are not now required by 70.53 to report the summary of the results. In the past, licensees voluntarily provided this information, which is used to determine compliance with NRC regulations and to provide data for NUREG-0430, Licensed Fuel Facility Status Report. Without a regulatory requirement or without licensee's voluntary submittals, NRC would have to conduct inspections to acquire SNM physical inventory data. In conjunction with this rulemaking, the form that licensees use to report summaries of SNM physical inventory data has been modified to include definitions of required data elements. TIMETABLE: NPRM to be determined LEGAL AUTHORITY: 42 USC 5841 EFFECTS ON SMALL BUSINESS AND OTHER ENTITIES: No AGENCY CONTACT: Sandra Frattali , Office of Nuclear Regulatory Research 301-443-7680
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DRAFT TEXT OF RULE AS PROPOSED TO BE PUBLISHED
Preposed Amendtent A .end 10 CFR 70.53 to read as follows: 70.53 Material Status Reports - .
- (c) Each licensee subject to the requirements of S70.51(e) shall submit
.to the appropriate liRC Regional Office listed in Appendix A of Part 73 of this chapter promptly upo'n determination of the quantities listed on the Stim Inventory Report (Form 11RC ) but not later than thirty (30) days from the start of the ending physical inventory required by 570.51(e)(3), an Stim Inventory Report containing the results of 'the inventory. The licensee shall report the inventory results by plant and total facility. If the inventory difference or
, its associated . limit of error exceed, rtspectively, the thresholds in 670.53(b)(1) or s70.53(b)(2), the statetents required by those paragraphs shall be attached to the Slim Inventory Report.
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DRAFT RECOMMENDATIONS TO ED0 RECOMMENDATIONS TO ED0 FOR CONTINUED RULEMAKING "C0DIFYING INVENTORY REPORTING REQUIREMENTS"
Background
The current material control and accounting regulations (MC&A) for fuel facili-ties, 10 CFR 70.51, require the performance of physical inventories of special nuclear material (SNM) by licensees on a periodic basis. Unless certain thresholds prescribed in 10 CFR 70.51 and 70.53 are exceeded, the current regulations do not require licensees to report the summary of the results to the NRC. This information is needed by the NRC to determine compliance with regulations and to provide data for NUREG-0430, Licensed Fuel Facilities Status Report-Inventory Difference Data. Recognizing this need, I&E instituted in 1975 a voluntary reporting system known as the Safeguards Status Report System (SSRS) whereby licensees were requested to report to the NRC physical inventory results in a prescribed format. Currently fourteen licensees voluntarily report physical inventory results verbally, with a written follow-up, to the appropriate regional office. However, in the absence of a regulatory requirement, if the licensees did not voluntarily submit these reports, NRC would have to conduct inspections to acquire needed SNM physical inventory data. Furthermore, the Paperwork Reduction Act of 1980 requires federal agencies making the same information request to ten or more persons to obtain OMB approval for the request, and to inform the recipients that if compliance is voluntary they need not respond. This means that so long as reporting to the SSRS remains voluntary licensees are not required to report. In addition, the NRC must obtain OMB approval each time such a request is made for the voluntary submittal.
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~To remedy this situation, I&E, in a memo dated June 2, 1982, requested that RES amend 10 CFR 70 to require licensees to report physical inventory results to the NRC. This rulemaking will include obtaining OMB approval for the informa-tion request.
Status I&E wants the subject rulemaking to proceed as requested in a memorandum to RES { dated May 16,1984(attached). Because of the importance of the SNM inventory data to the NRC inspection program, the staff believes that the reporting of ! this inventory data should have a regulatory basis. A proposed rule package is I being prepared and will be submitted for office concurrence. l Recommendations Since SNM inventory information is needed by I&E and the rule would codify ' existing practice with little or no impact on licensees, the NRC, or the I public, it is recommended that this rulemaking should proceed. i 2 l l i l
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RESULTS OF SCREENING PROCESS
SCREENING ANALYSIS
- 1. The issue to be addressed, i.e., the problem to be corrected.
o To require reports from licensees of summaries of the results of physical inventories for special nuclear material (SNM).
- 2. The necessity and urgency for addressing the issue.
o Currently, information on the results of physical inventories of SNM required by the NRC is voluntarily provided to the NRC in narrative form. The fourteen licensees voluntarily report verbally, with a written follow up, the results of physical inventories to the appropriate regional office. This rulemaking would make the reporting mandatory.
- 3. Alternatives to rulemaking, o (1) Combining the reporting requirement with the MC&A reform amendments.
(2) Combining the SNM inventory reporting with present material accounting reports. (3) Conduct inspections to acquire the results of physical inventories of SNM. (4) Maintain status quo, rely on voluntary information.
- 4. How the issue will be addressed through rulemaking.
o The proposed rule would require licensees to report information on the results of physical inventories of SNM. The form which is currently used by licensees to report summaries of SNM physcial inventory data will be modified to allow for inclusion of the required additional information. The modification will provide definitions of the required data elements.
- 5. How the public, industry, and NRC will be affected as a result of rulemaking, including benefits and costs, occupational exposure, and resources.
O Codifying the SNM inventory reporting which is currently a voluntary practice would have minimal impact on licensees and will ensure NRC is provided the information it needs. In addition, since the voluntary SNM reporting was instituted in 1975, predating the Paperwork Reduction Act of 1980, the voluntary reporting has never been through the OMB clearance process required. This requirement will now be fulfilled.
4 1 i 1 i l i i 2 k j I
- 6. NRC resources and scheduling for the rulemaking.
i o - Contractual Funds Required - none , 1 Professional Staff Months - 3 months NPRM to be determined. i t i 4 I' i 4 i j' e i i 1 e 1 I t i I t i f f a 1 x i l i i j t r.-e- - , ..-.-.n~.----.-,,-----n,-n-..~., .n.- . .--_-n.,--,n,--. - - - - - - -r
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MEMORANDUM FOR: James A. Norberg, Chief Hur.an Factors and Safeguards Branch Division of Risk Analysis and Operations, RES FROM: Leonard I. Cobb, Chief Safeguards and Materials Programs Branch Division of Quality Assurance, Safeguards, and Inspection Programs, IE
SUBJECT:
CONTINUATION OF RULEMAKING FOR CODIFYING INVENTORY REPORTING REQUIREMENTS FOR SNM LICENSEES (10 CFR 70.53) My Division management has reviewed R. B. Minogue's memorandum of March 16, 1984 regarding the plan for NRC rulemaking. As a result, we request that you please take the steps necessary to have the ED0's office review and approve the continu-ation of the rulemaking process for codifying the physical inventory requirements for SNH licensees. The enclosed namorandum of March 30, 1984 from me to Ed Fox of IE n3y be useful to you, becayse it covers our rcasons for continuing the rulemaking process that we initiated. We plan by August 1984 to provide you with the final versions pf 10 CFR 70.53 and the definitions of the items that SNM licensees will have to report.. (Intemediate activity completion dates are not appropriate for our technical work on this rulemaking.) Thank you for your help. Please let me know if you have questions or coments. _ f ,' Leonard I. Cdtf(, Chidf Safeguards and Materials Programs Branch Division of Quality Assurance, Safeguards, and Inspection Programs, IE
Enclosure:
As stated , cc: W. Brown, NMSS J. Partlow, IE E. Fox, IE S. Peros, IE P. Ting RES
h rch 30, 15U. DCS MEMORANDUM FOR: Edain F. Fox, Jr. , Technical Assistant Program Support Branch, IE FROM: Leonard I. Cobb, Chief Safeguards and Materials Programs Branch Division of Quality Assurance, Safeguards, and Inspection Programs, IE
SUBJECT:
CONTR01. 0F' NRC RULEMAKING: R.'C. DEYOUf!G'S MEMORANDUM 0F MARCH 19, 1984 The enclosure to the subject memorandum should include the SMPB activities related to the rulemaking " Reporting of Material Accounting Data" that will modify 10 CFR 70.53 to require SNM licensees to report the results of their physical inventories. This action has a history dating back to about 1975, which is sumarized in the enclosure. The following are discussions of each of the review items required by the subject menorandum.
- 1. The Problem to be Corrected: SNM licensees are required to conduct inventories, but they are not legally required to report the results to NRC. These results have, until now, been reported to the affected Regions because of informal verbal arrangement made in the past. The problem is that if licensees chose to ignore the informal agreement, the NRC's only recourse would be to conduct special inspections to get the information. Such inefficencies and extra costs should not be necessary,
- 2. The Necessity End Urgency for Addressing the Issue: I cannot explain why the-issue was not resolved in the past, and I think that you may feel the same way after you read the enclosure. Regardless of what has or has not happened and the why's, the Co rnission does not need the potential problem of explaining why SNM licensees are not required to provid:: inventory difference data for the ID Report (NUREG-0340). Thus, the rulemaking should be completed at the earliest possible date.
- 3. Alternatives to Rulemaking: The ur. acceptable alternative is to
- continue to rely on the good graces of licensees for reporting the results of their physical inventories.
- 4. How the Issue Will Be Addressed Through Rulemaking: 10 CFR 70.53 will be rewritten to require SNM licensees to regularly report the results of physical inventories.
- 5. Affects of Rulemaking: There will be no measurable increase in costs to licensees or to the public as a result of this rulemaking. The public will have the assurance that the Co mission requires SNM licensees to report the results of physical inventories.
s . . Edwin F. Fox 2
- 6. fiRC Resources and Scheduling fieeded for the Rulemaking: By about the end of April, 1984, SMPB will have coordinated and completed the documentation needed by RES to carry the rulemaking through the final stages. We see no significant resource needs for SMPB or RES. The reporting requirements should be codified by this sumner.
I think you should be aware of some of the problems SMP3 has encountered in this project. It began in September,1983 in meetings with f; MSS and RES regarding the need for NRC to continue to require Stim licensees to file DOE /tiRC Form 741 (Nuclear Material Transaction Reports), DOE /tiRC Form 742 (Material Balance Report), and DOE /NRC Form 742c (Physical Inventory Listing). In the course of these discussions, the NRC Form 327 (SNM In'ventory Balance Report) came up, along with the outstanding issue (since 1975) of requiring licensee to complete the report. Follow-up cn these documents revealed that not only was there no documented requirement for licensees to report SNM data, but that the definitions of the items on NRC Form 327 were known only by word-of-mouth; the neanings of the items to be reported have never been written down. We began the process of drafting the definitions of the quantities that licensees would have to report, and which the Regions would have to evaluate. This draft process has recently been ccmpleted in coordination with NMSS and the Regions. A revised NRC Form 327 that includes definitions of what licensees are to report will be made available for public corment along with the codification of reporting requirements in 10 CFR 70.53. Further, SMPB will develop a Manual Chapter that formally requires the
. Regions to evaluate licensee reports, and to' initiate actions to correct deft-ciencies and to issye citations for violations.
I believe that this ruler..aking should be completed and hope that you will help formalize the EDO requirement for doing so. Leonard I. Cobb, etc. Safeguards and Materials Programs Brench Division of Quality Assurance, Safeguards, and Inspection Programs, IE
Enclosure:
As stated cc: J. G. Partlow, IE Distribution liC$ SMPS reading / subject QASIP reading J. Counts, IE , L. Cobb, IE SMPB:lE SMEIJE JCcunts LC6bb 3/u/84sc 3/P I /84 rw$ 0.eut. -
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{ iO CRANDUM FOR: Robert B. Minogue, Director Office of Nuclear Regulatory Research FROM: Richard C. DeYoung, Director . Office of Inspection and Enforcement -
SUBJECT:
AMENDMENT TO 10 CFR 70 TO REQUIRE REPORTING . OF INVENTORY RESULTS TO NRC T.he current material accounting regulations for fuel facilities require the perfomance of measured physical inventories by licensees on a periodic basis (10 CFR 70.51). Unless certain thresholds prescribed in 10 CFR 70.51 and 70.53 are exceeded (in which case some limited inventory results are reported), the , current regulations do not require licensees to report inventory results to NRC. . In 1975, faced with new inventory requirements in Part 70, an unreliable system for reporting material accounting data to Headquarters, and a need for tirely, accurate data to help in making safeguards decisions and in responding to incidents and inquiries, IE instituted a reporting system under which licensees were requested to report inventory results in a prescribed fomat to Regional Offices, who in turn would forward the results to IE Rcadquarters. This system is. called the Safeguards Status Report System (SSRS) and the reporting form used is called the SNM Inventory Report. The institution of this system was an 1 ir.ternal IE initiative and the response to it by licensees was not required by > URC regultc. ions. The role of the SSRS expanded in 1977 when its inventory difference (ID) data was used as the basis for the of ficial NRC inventory difference data released to the public in the first publication of NUREG-0350, _Re, cort on _Stratecic_ Seecial l'uclear Material Inventory Differences. The SSRS has served as the scurce of data for each subsequentTfic report on ID's to the public. The Paperwork Reduction Act of 1980 requires federal agencies making the same ir.fomation' request to ten or more persons to obtain OMB approval for the request, and to infom the recipients that compliance is voluntary and they need not respond. This means that so long as reporting to the SSRS voluntary, (1) licensees may refuse with impunity _to report,
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- ~
in technical violation of the law. , Te remedy the above untenable situation, I am simultaneously (1) asking RES to arend 10 CFR 70 to require the reportino of inventory results to the NRC in the ferr.at of the SNM Inventory Report and (2), by septrate memorandum, requesting , ACM to secure OMB approval of the SNM Inventory Report Form. k'e have been ac' vised by the /.DM staff that OMB approval of the reporting form is unlikely in the absence of. regulatory requirements for reporting the data contained itgrein.. g . - L l
t J;cb et,B. Minogue, EES -E- . Enclosure 1 consists of draft language for a new 10 CFR 70.53(c) that would
. require licensees subject to the inventory requirements of 10 CFR 70.51(e) to report the results of their inventories to the appropriate Regional Office within 30 days of the start of an inventory. Their reports would be submitted just as they are now, in the form of an Stim Inventory Report (copy contained in Enclosure 1). My staff has reviewed our files regarding codification of inventory reporting, and we find that IE has nade several requests for anendment of 10 CFR 70 to require the reporting of inventory data. (See .
Enclosure 2 for a chronology of ' previous efforts to codify inventor reporting.) Al't'heugh the safeguards situation has changed somewhat since IE made its first request in 1975, the basis is still valid: (1) we need a rule change to assure licensee compliance with our request to report inventory data (Knuth to Minogue, 1975), and (2) the SSRS is the source document for the . inventory difference data routinely released to the public (McCormick te Jones,1978). Va now have the additional reason that our current system of collecting this infor.Tation is jeopardized by the Paperwork. Reduction Act, and indeed may be, without an appropriate rule change and OH3 approval, technically illegal. In the course of our review of the evolution of the SSRS into its present form, we found that a proposed rule to codify the licensee practice of reporting inventory results to the fiRC was published for comment in the Federal Recister in August of 1976. A copy of this proposed rule is found as Enclosure 3, and we believe it serves as an excellent starting point for a renewed rulemaking action.
. These are several other.g,ermane points regarding our request that I wish to make: i -
(1) Action on this rule should proceed as soon as possible and should not be tied to, delayed by, or otherwise associated with other pending rulemaking initiatives affecti.ng 10 CFR 70 (e.g. , the MCM Reform Amendments for strategic facilities and the LEU Reform Rule for LEU facilities). The need for the inventory reporting rule is ir. mediate in order for tiRC to expeditiously monitor compliance with current accountability regulations and to comply with the Paperwork Reduction
, Act. If the proposed reform amendments for strategic and/or LEU are
, eventually approved (liMSS staff projects a mid-1985 implementation i date 'for the HEU Reform Amendments), the inventory reporting i requirement can be modified as appropriate. [This is a chan i cur 1981 request (Brown to Evans). The long lead time assoc'ge iated frem
- . _ with the Reform Amendments arid the. pre.s.ent untenable situation with j rcgard to the Paperwork Reduction Act dictate that the requested "
i change to require reporting of inventory results not be linked to j other initiatives such as the Reform Amendments.) l ' I i
. s
i E;isrt.3. ".ir T.2, .ES (2) Given that essentially the same rule change we are requesting was previously published for cc=ent, we endorse lir. l'cCormick's 1978 request that the insentory reporting rec,uirements be published as an effective rule. (3) The impact of this requested rule change is minir.al. Presently
. J. seventeen (17) licensees are reporting voluntarily under the 55RS
. ' ' [ ^" systen. The propcsed rule w::uld require the same licensees to raport the same data they are now reporting voluntarily; hence, there would
- n ,
.. .. be no increased (or decreased) burden on the licensees. The only .
impact of this rule would be liRC staff time required to promulgate it, and fortunately, much of this work has already been done. (4) The requested requirement does not duplicate existing reporting requirements for accountability infermation in 10 CFR 70. The existing requirements are for submission of reports of transactions (70.54) and of semi-annual book inventory data (70.53(a)) to the h'uclear Materials Management and Safeguards System (IF.M55). The SSRS data is based on the actual results of each physical inventory, not book balances. Moreover, for the plants of prirary safeguards significance, the inventory frequency is set by 10 CFR 70.51 at bimonthly, not semi-annual, intervals. (5) The infon.ation reported on the SNM Inventory Form includes data other than inventory differences that is used by the l'RC staff in analyzing accountability performance of licensees and in auditing licensee records. Hence, a rule change that required licensee reporting of ID and LEID only would not be sufficient to meet programmatic needs. .
. r .. .-
I consider timely arid positive action on this request to be of utmost irportance. We set a very bad example fo. our lice sees, whom we expect to fellcw the rules we promulgate, if we do not oursei es adhere strictly to the letter and intent of laws or regulations that apply to us.
. o r i g ir.a 1 @ d D R. C. Mod Richard C. DeYoung, Director .
Office of Inspection and Enforcement Er.cl e s u re s : As stated cc: Y. Stello, DED/ROGR J. [ avis, hMSS . P. Ncrry, ADM
- .. Fayrc s , R-I q Jn O'r.eilly,R-II 1 1 '
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Enclosure 1 . Preposed Amendcent Amend 10 CFR 70.53 to rerd as follows: 70.53 Material Status Reports -
-- (c) Each licensee subject to the requirements of 570.51(e) shall submit
.to the appropriate NRC Regional Offic'e listed in Appendix A of Part 73 of this chapter promptly upon determi,ation of the qtantities listed on the SNM Inventory Report (Form NRC ___) but not later than thirty (30) days frcm the start of the ending physical inventory required by 570.51(e)(3), an SNM Inventory Report centaining the results of the inventory. The licensee shall report the inventory results by plant and total facility. If the inventory difference or
. its associated . limit of error exceed, respectively, the thresholds in 570.53(b)(1) or S70.53(b)(2), the statements required by those paragraphs shall be attached to the SNM Inventory Report.
6 __ e . *
- 6
i ., h r.ua ry 24, 1975 Deputy Director for Field Operations (Davis) issues l mem^randum to Regional Directors. " Effective imediately, Regicns are to make ' arrangements with licensees required to perform SNM inventories to , receive promptly from the licensee the results of each inventory perfomed to meet regulatory requirements." The Davis memorandum encloses a copy of a draft SNM Invento,ry Report Fom. February 4',1975 Director of IE (Knuth) sends a memo to Acting , Director of Standards Development (Minogue). Citing the fact that there is a growing concern surrounding MUF data, he said IE was establishing a program to systematica11y review and evaluate-licensee inventory data. To initiate the program, IE had asked Regicnal Offices to obtain MUF and inventory data from licensees on a voluntary basis. In order to assure compliance, he asks that 10 CFR 70 be amended to require all licensees to routinely report the results of each physical inventory conducted pursuant to
~' ~
70,.51(e).
- February 11, 1975 Deputy Director for field Operations, IE (Davis) ,
sands final format fcr Regional repoiting of ir.ventory data to HQ. "Ai rangt erts for the licensee to rc. port this information should' te established betUeen the J
- w '
- ,,e .t u e,... - i
. \
. April 17, 1975 Chief, Materials and Plant Protection Branch, Region 1 (Martin) sends memorandum to IE Headquarters (Whitetker) suggesting that semi-annual material status reports (MSR) (For.2 NRC-742 report to IMMSS ,
system in Oak Ridge) be modified to " closely res~emble , the SNM Inventory Report as promulgated by J.G. Davis, DDFO." Mr. Martin's recomendation was based on the argument that the MSR reporting system was not oriented toward the safeguards requirements promulgated in the proceeding year and had beccme "an obsolete Safeguards docurant for our major fuel facilities." "Until recently, the accountability
.. systems at our major licensees were geared toward g .
being compatable with MSR reporting. The new
. regulations and SNM Inventory Reports clearly require a different accounting system."
October 20, 1975 . Director of IE (Knuth) sends a memorandum to Director of HMSS (Chapman) observing that the accountability
. information collected through the voluntary system of
" ~ ~ licensee reporting appeared to provide "a basis for evaluation of the impact and effectiveness of the accountability portion of the NRC nuclear materials ' safegua$-dsprogram. We are presently initiatir.g a more detailed review.in. an attempt to assess the
i .
, t 4
effect of our inspection and enforcement program on the performance of individual licensees. We believe that there are nore fertile areas for study. made possible by the presentation of this data such as: determination of the overall effectiveness of the present rules governing nuclear materials account, ability in the safeguarding of nuclear . materials, the effects of rule changes on licensee performance, the level of confidence one can assign to 1 the overall accountability system or to the accountability systems for individual licensees, statistical bases for evaluating present MUF's based
~
t on past performance, and others. 1 Program evaluation in the nuclear materials safeguards accountability area is possible because licensee and industry performance is directly measurable. The influence of regulatory requirements and our inspection and enforcement program on licensee, L --- pe.rofrmance can .be inferred with precision." , December 5, 1975 Director of NMSS (Chapman) sends a memorandum to , Director of SD (Minogue) recommending postponement of action on the proposal to codify the system of
. voluntary reporting. .
S g w .. . - -
- 1 December 24, 1975 Director of SD Division of Siting, Health, and Safeguards Standards (Mattson) responds,to Chapman's December 5,1975 memorandum., saying that SD has decided to delay the rulemaking action as requested by, NHSS. .
January 28, 1976 Acting Director of IE.(Davis) responds to the Decembe,r 5,1975 Chapman memorandum and the December 24, 1975 Mattscn memorandum. "In response to the concern of the Concission, IE has institdted a system , to monitor licensee material balance and MUF data on a timely basis. ...In order for the effort to be
,. e.ffective, licensees must promptly report results of their periodically required physical inventories of SNM. At the present time, IE is obtaining SNM material balance accounting information from major licensees on a voluntary basis. The voluntary nature /
of this monitoring effort does not provide a mechanism for enforcement action in those cases in which licensees fail to promptly or routinely submit.
~~
ne.cessary safesvards 'maferial balance data. - -' I s
i ,
. e t
Notwithstanding the position taken by NM55 in Mr. Chapman's December 5,1975 msmorandum to you, we believe that the requested amendment _ requiring reporting of Safeguards material accounting inforNation is important and should be published at
~
the earliest possible tire. k'e initially requested action on the proposed amendment in D.F. Knuth's memoran,dum to you of February 3,1975. Postponing action until the Spring of 1976 as recommended by NMSS appears to be inconsistent with the current NRC . mandate to upgrade the safeguarding of SNM held within the private sector. k'e request that you reconsider the decision to postpone action on the proposed staff paper on licensee reporting of Safeguards material accounting l information. It is our position that timely action is f needed to assure that NRC has the enforcement . capability to obtain material balance data within the nuclear fuel cycle on a timely basis." . February 12, 1976 Director of NMSS (Chap .an) accedes to IE's wishes for early publication. "In view of the urgency which the , Office of inspecticn and Enf'orcement attaches to this matter, I new support their recommendation for prcmp,t
- . action."
i '
March 3,-1975 Director of SD Divisien of Siting, health, and Safeguards Standards (Mattson) circulates draft Comission paper and rule package for other office censideration and concurrance. c
- = <
t Jcne 14, 1976 SECY-R-75-320, Comnission paper entitled " Reporting of Material Accounting Infomation," is foniarded to the Compission for action. July 20,1976 Secretary (Chilk) sends EDO (Gossick) a memorandum outlining Comission's decision on SECY-76-320 - Reporting of Material Accounting Inforh.ation. Th e Comission, by a 4-0 vote: (a)approvedpublication for public coment of amendments to 10 CFR Part 70 which would require licensees to report r.aterial . accounting infohr.ation to tiRC after each physical inventory." August 1976 . fiRC publishes for public comenFthe proposed amendment to 10 CFR 70.53 which would require . licensees to s0bmit 'to Ge regional offices material balance data for each physical inventory conducted pursuant to 10 CFR 70.51(e). - 1977 Action on preposed ' rule dropped. Available lE files do not indicate reason. *
~
. - ... l - . . . ~ _ _ . _ . , _ _ _ _ _ -
i 4 April 12, 1978 lE Assistant Director for Safeguards Inspection I (McCormick) requests SD (Paterials Protection Standards Branch) to reinstitute rulemaking action i for the reporting of inver. tory data. " Licensees are presently reporting this' data to the regional offices on a voluntary basis. 'We believe that actions should be initiated now to review, modify, where necessary, and publish this proposed amendment as an effective rule." j !1cCormick notes a new use for the data reported under the voluntary system: "In August 1977, the Connission initiated a program of routinely releasing to the s public inventory difference data. The prinary source of this data is the SiiM inventory report which the licensees are providing voluntarily. k'e believe that - l i the data base for the release of inventory difference data to the public should be based on a regulatory l , requirement which requires licensees to provide the material balance data to the Corraission." . i L. . .
. - ~ . _ - . . - - _ .- - .
(. , March 17, 1981 R-II Accountabiiity Section Chief (McAlpine) forwards reccmmendation to IE Headquarters that reporting of inventory data be made a regulatory requirement. "The following recommendation is made to improve Safeguards perfo'rmance (note: Although the licensee is' in compliance with all requirements, regulatory changes " or modifications in . existing licensee conditions may be required to achieve adequate Safeguards performance.): The Results of each SNM inventory performed by licensees to meet regulatory requirements, are currently being forwarded .to the appropriate region in i accord with arrangements made in the past between the region and the licensees. It is' recommended that reports of licensee SNM inventory results be made a regulatory requirement, with a copy to the appropriate region, within 30 days following the start of the physical inventory."
*pril 23,1981 I,E Safeguards' Branch Chief (Brown) forwards to NMSS Regulatory Improvements Branch Chief (Evans) the Region II recommendations, requesting that 10 CFR to ,
be amended to include requirements for reporting of inventory data.
. May 20,1978 SD Chief, Materials Protection Standards Branch (Jones) responds to IE's April 12, 1978 memorandum:
" Action has baen initiated to propose amendments for the additional reporting requirement requested in the .
subject memorandu,m. 'Je anticipate that a draft' ComT.ission Paper will be distributed for staff review
. by the end of June,1978."
Mid 1978 NMSS (staff) lobbies SD to postpone action on rule to wait for MCEA Upgrade Rule. 50 accedes to NMSS. 4 July 1978 , NMSS Material Control Licensing Branch issues generic
.. letter and license condition to licensees subject to 10 CFR 70.51(e). The letter says in part j
... inventory differences should continue to be reported to the"NRC Regional Office using the established SNM Inventory Report." A new license condition was added which required the reporting of ID data to the regional offices within 30 calander days k of start of an ending physical inventory.
- Late 1978,1979,1980 No apparent action on proposed rule. Available IE files do not indicate reason. A;;arently stopped by NMSS staff request, citing linkage to propesed MC&A Upgrade Rule. .
~.
e I' y ISSI-!'ay 19E2 No action on proposed rule, f,'o apparent IMSS respor.se to 1E April 1981 request. P.ty 1952 IE (DeYoung) request to RES (Minogue) to reinstitute . ruleaking acti~on to require licensee reporting 'of inventory data to NRC. O
' ~
t 4 O 4 G O e e O e O v.-
C0 ORDINATION WITH USER OFFICE
5"D'*%, UNITED STATES y- 4 NUCLEAR REGULATORY COMMISSION I- o WASHINGTON, D. C. 20555
% ej \...**/ JUL 0 61984 MEMORANDUM FOR: John N. Grace, Director Division of Quality Assurance, Safeguards and Inspection Programs, I&E FROM: Robert M. Bernero, Director Division of Risk Analysis and Operations, RES
SUBJECT:
DRAFT RECOMMENDATIONS TO ED0 CONCERNING WHETHER AND HOW TO CONTINUE WITH " CODIFYING INVENTORY REPORTING REQUIREMENTS" RULEMAKING SPONSORED BY RES Enclosed for your consideration are draft recomendations supported by a draft office review concerning whether and how to continue with " Codifying Inventory Reporting Requirements" rulemaking sponsored by RES for which your office is identified as the user office. This memorandum constitutes my concurrence in the enclosed draft recommendations which will be submitted to the Director, RES, within two weeks of the above date. Please acknowledge receipt by returning this memorandum within two weeks of the above date with or without comments on the draft recommendations as indicated below.
~ -- c Robert M. Bernero, Director Division of Risk Analysis and Operations, RES
Enclosure:
As stated Recipt Acknowledged. No Comments
% t Acknowledged. Comments fol PLEASE SEE COVER MEMO Date: lily 18, 1984 John N. Grace, Director Division of Quality Assurance, Safeguards and Inspection Programs, I&E
#p"ruq% JUi. 2 0 1984 UNITED STATES 8 "hi NUCLEAR REGULATORY COMMISSION
,E WASHINGTON, D. C. 20555 g ..... p8 July 18, 1984 MEMORANDUM FOR: Robert M. Bernero, Director Division of Risk Analysis and Operations, RES FROM: J. Nelson Grace, Director Division of Quality Assurance, Safeguards, and Inspection Programs, IE
SUBJECT:
YOUR MEMORANDUM OF JULY 6, 1984 C0VERING DRAFT RECOMMENDATIONS TO ED0 CONCERNING WHETHER AND HOW TO CONTINUE WITH " CODIFYING INVENTORY REPORTING REQUIREMENTS" RULEMAKING SPONSORED BY RES We have reviewed the subject draft document and are forwarding comments and changes. If the specific changes indicated below are made, I concur in the revised document.
- 1. NRC REGULATORY AGENDA, ABSTRACT.
Comments: First sentence: The reporting requirements involve data in addition to the inventory difference (ID) and the limit of error of the ID (LEID). We know that the quantity " standard error of inventory difference (SEID)" will be used in future changes to 10 CFR 70. However, the present version of 10 CFR 70 refers to limit of error, and we want to use LEID for now. Second sentence: The new 10 CFR 70.53 (c) will affect licensees in addition to those that possess more than "one effective kilogram." General: The reports now indicated in 10 CFR 70.53 are based on " book" inventories. It is critical that IE's SNM inventory report is based on the results of " physical" inventories. Changes: Change the ABSTRACT to read:
"The NRC is amending its regulations in 70.53 to require affected licensees to report data summarizing the results of physical inventories of special nuclear material (SNM). The affected licensees are required by 70.51 to conduct the physical inventories but are not now required by 70.53 to report the summary of the results. In the past, licensees voluntarily provided this information, which is used to determine compliance with NRC regulations and to provide data for NUREG 0430, the Commission's Licensed Fuel Facility
,. r Robert M. Bernero 2 Status Report. Without a regulatory requirement or without licensee's voluntary submittals, NRC would have to conduct inspections to acquire SNM physical inventory data. In conjunction with this rulemaking, the form (NRC 327) that licensees use to report sumaries of SNM physical inventory data has been modified to include definitions of required data elements."
- 2. NRC REGULATORY AGENDA: Timetable, Notice of Proposed Rulemaking.
Comment: September.30, 1984 was suggested in L. Cobb's memorandum of June 1, 1984 to J. Norberg as a date for publishing a Federal Register notice. Because we do not know if and when the ED0 might approve this rulemaking, and because the ED0's memorandum of February 13, 1984 prohibited work on this rulemaking before it is approved, we feel that it is prudent to leave the date open for now. If the ED0 approves our rulemaking, we can establish a timetable when we receive a suggestion in a proposed Task Control Fonn from RES.
- 3. Proposed Amendment Change: Replace the older version of the proposed amendment in your memo-randum with the version included with L. Cobb's memorandum of June 1, 1984 to J. Norberg except that the phrase "Where applicable," is to be inserted at the beginning of the last sentence, and " standard error" is to be replaced with " limit of error."
- 4. SCREENING ANALYSIS:
Item 1." Replace "of inventory difference (ID) and standard error of inventory difference (SEID)" with "of summaries of the results of physical inventories." Item 2.: Replace "ID and SEID" with "the results of physical inventories." Item 3., line 2: Please clarify the phrase "above material accounting reports." Item 3.: In addition to the option of continuing the present practice, IE could conduct inspections to acquire the results of physical inventories of SNM. Item 4, first sentence: Replace "ID and SEID" with "the results of physical inventories." Ite.m 4., second sentence: Replace this sentence with "The form that licensees use to report summaries of SNM physical inventory data has been modified to include definitions of required data elements."
Robert M. Bernero 3
- Item 5, line 6 down
- Replace "1985" with "1975."
Item 6.: Replace "2 months" with "3 months", because IE's regional programs are involved. Replace "09/30/84" with "to be determined."
.- c.
J. Nelson Grace, Director Division of Quality Assurance, Safeguards, and Inspection Programs, IE
Enclosure:
Memorandum dated July 6, 1984 4
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- _ _ _ - _ . - - - - - - - - - - - ~
e nto UNITED STATES e f , ) g( ; NUCLEAR REGULATORY COMMisslON WASHINGTON, D.C. 20555 b Q W% ,,,, fi/ 46 OCT % 21984 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING Based on our review of the ongoing RES sponsored rulemaking " Licenses and Radiation Safety Requirements for Well-Logging Operations--10 CFR Part 39," RES recomends that the NRC should proceed with this specific rulemaking. This Material Safety andinSafeguards. recommendation, draft form, has been coordinated with the Office of Nuclear The basis for our recommendation is as follows: The proposed rulemaking would: (a) provide greater uniformity of NRC regula-tions with those of Agreement States and regulations likely to be adopted by Agreement States as suggested by the Conference of Radiation Control Program Directors, (b) consolidate in one part of the regulations requirements for handling irretrievable well-logging sources now contained in 10 CFR Parts 30 ; t and 70; (c) provide a consistent and improved basis for regulation of these. l devices and operations; and (d) lead to improved safety of well-logging devices and operations through application of the regulations. In addition, utable the annual total collective dose and individual exposures attrib-to well-log \ l Radiation Exposureging operations as shown in NUREG-0174, Vol. 1, " Occupational l category in the nuclear industry.-Twelfth Annual Report 1979" are among the highest for any These data give added priority for NRC action to 10 proposed reduce exposures CFR Part 39. in this industry, as should be provided by the The complete RES review package has been sent to OEDO (Attention: { to the Director, NMSS. DEDR0GR)and
-vY h '
Robert B. Minogue, Director Office of Nuclear Regulatory Research i f
\
_ _ _ _ _ _ . _ . _ - - - - - - - - - - - - - - - - - ~ - ' - - -
P o UNITED STATES [po asc $*g NUCLEAR REGULATORY COMMISslON E g WASHINGTON, D. C. 20555 I !
% ,,,,, 001 % z 1984 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING Based on our review of the ongoing RES sponsored rulemaking " Licenses and Radiation Safety Requirements for Well-Logging Operations--10 CFR Part 39," RES recomnends that the NRC should proceed with this specific rulemaking. This recomendation, in draft form, has been coordinated with the Office of Nuclear Material Safety and Safeguards. The basis for our recomendation is as follows: The proposed rulemaking would: (a) provide greater unifomity of NRC regula-tions with those of Agreement States and regulations likely to be adopted by Agreement States as suggested by the Conference of Radiation Control Program Directors, (b) consolidate in one part of the regulations requirements for handling irretrievable well-logging sources now contained in 10 CFR Parts 30 and 70; (c) provide a consistent and improved basis for regulation of these devices and operations; and (d) lead to improved safety of well-logging devices and operations through application of the regulations. In addition, the annual total collective dose and individual exposures attrib-utable to well-logging operations as shown in NUREG-0174, Vol. 1, " Occupational Radiation Exposure--Twelfth Annual Report 1979" are among the highest for any category in the nuclear industry. These data give added priority for NRC action to reduce exposures in this industry, as should be provided by the proposed 10 CFR Part 39. The complete RES review package has been sent to OEDO (Attention: DEDROGR) and to the Director, NMSS. 4 Robert B. Minogue, Director Office of Nuclear Regulatory Research
F RES INDEPENDENT REVIEW PACKAGE l 6 l l l l k
RES INDEPENDENT REVIEW BOARD VOTING SHEET i T0: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: N. k. gp TITLE OF RULEMAKING: " Licenses and Radiation Safety Requirements for Well-Logging Operations -- 10 CFR Part 39" AGREE WITH DRAFT RES REQUEST RIRB INDEPENDENT RECOMMENDATIONS MEETING. IN DRAFT INDEPENDENT REVIEW PACKAGE. MODIFY DRAFT RES NOT PARTICIPATING. INDEPENDENT RECOMMENDATIONS I AS INDICATED BELOW. COM'<ENTS AND SUGGESTIONS: iV MEMBER, RIRB NfE DATE
r ~ o RES INDEPENDENT REVIEW BOARD VOTING SHEET TO: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: 0. E. BASSETT, MEMBER, RIRB TITLE OF RULEMAKING: " Licenses. and Radiation Safety Requirements for Well-Logging Operations -- 10 CFR Part 39"
,- AGREE WITH DRAFT RES REQUEST RIRB INDEPENDENT RECOMMENDATIONS MEETING.
, IN DRAFT INDEPENDENT REVIEW PACKAGE.
l MODIFY DRAFT RES NOT PARTICIPATING.
! INDEPENDENT RECOMMENDATIONS I AS INDICATED BELOW.
COM.ENTS AND SUGGESTIONS: Whff0W
- 0. E. BASSETT MEMBER, RIRB T[Z/[T'/-
DATE
r gsia vd RES INDEPENDENT REVIEW BOARD VOTING SHEET T0: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: K. R. GOLLER TITLE OF RULEMAKING: " Licenses and Radiation Safety Requirements for Well-Logging Operations -- 10 CFR Part 39" j AGREE WITH DRAFT RES REQUEST RIRB V INDEPENDENT RECOMMENDATIONS MEETING. IN DRAFT INDEPENDENT REVIEW PACKAGE. MDDIFY DRAFT RES NOT PARTICIPATING.
, INDEPENDENT RECOMMENDATIONS I AS INDICATED BELOW.
COMMENTS AND SUGGESTIONS: MEMBER, RIRB 7/a 4 4 DdTE
a ; l I i i I I I RES REVIEW PACKAGE I f I l k i i i }
m
*"% t UNITED STATES g
yo 4 NUCLEAR REGULATORY COMMISSION
) 7.h WASHINGTON, D.C. 20555
%,...../ AUG 2 01984 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
REVIEW BY ED0 0F ONG0ING RULEMAKINGS SPONSORED BY RES Enclosed is the review package of the following specific ongoing rulemaking for which RES is the sponsoring office, titled " Licenses and Radiation Safety Requirements for Well-logging Operations." This submittal responds to the memorandum dated April 9,1984 from J. M. Felton, Director, Division of Rules and Records, ADM, requesting offices to update NRC Regulatory Agenda entries. I recommend that the NRC continue with this rulemaking. The basis for this recommendation is as follows: (1) The proposed rule would provide comprehensive and consistent regulations applicable to well-logging operations. Current NRC regulations do not provide specific requirements but impose them as licensing conditions. (2) The proposed rule would incorporate requirements similar to Part W of the Suggested State Regulation. Four Agreement States have adopted Part W as State regulations and more Agreement States are considering adoption of Part W. Consistency between NRC and Agreement State regulations is essential for well-logging operations because many companies operate in both Agreement and Non-Agreement States. (3) The proposed rule includes safety requirements designed to reduce the likelihood of incidents involving the rupturing of radioactive sources and spreading of radioactive contamination principally from operations to remove a stuck source from a well-logging device or to retrieve a well-logging davice lost in a well. (Fivesuch incidents occurred between August 1982 and September 1983). I recommend that the NRC proceed with the rulemaking as follows:
- a. Publish the proposed rule in the Federal Register in October 1984
- b. Allow 90 days for public coments
- c. Complete final rule in 1985.
To: W. J. Dircks 2 406 2 0 1984 My recomendations have been coordinated in draft fonn with the Director, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards. b bg Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
RES Rulemaking Review Package for Well-logging Operations i
TITLE: Licenses and Radiation Safety Requirements for Well-logging Operations CFR CITATION: 10 CFR 39 ABSTRACT: The rulemaking would impose radiation safety requirements on licensees who perform operations such as well-logging, mineral-logging, radioactive markers and subsurface use of radioactive materials in tracer studies. Current NRC regulations do not address these operations except in a general way. This task would adopt the requirements in the Suggested State Regulations for Control of Radiation Part W as new NRC regulations. Two alternatives were considered: maintain the status quo and promulgate new requirements. Potential costs would be: about one man-year effort for the NRC and about $1,000,000/yr for industry to. implement the new requirements. Since most requirements are alreidy complied by the licensees under licensing conditions, the net increase in cost beyond the current requirements would be about $80,000 per year. The major benefits are: (1) having a comprehensive set of requirements, and (2) minimizing the effort required to obtain reciprocity for NRC licensees to operate in Agreement States or vice versa. TIMETABLE: NPRM 10/00/84 LEGAL AUTHORITY: 42 USC 2201, 42 USC 5841 EFFECTS ON SNALL BUSINESS AND OTHER ENTITIES: No AGENCY CONTACT: Anthony N. Tse Office of Nuclear Regulatory Research Washington, DC 20555 301 443-7902 _ BOO
SUPPORTING STATEMENTS TITLE:
- Licenses and Radiation Safety Requirements for Well-logging Operations CFR CITATION:
10 CFR 39 TASK LEADER: Anthony N. Tse (X37902) SCREENING:
- a. The issue to be addressed.
Existing Commission regulations do not specify detailed safety require-ments governing the use of licensed material in weal-logging operations.
- b. The necessity for addressing the issue.
The rulemaking action is needed to provide comprehensive and consistent regulations to ensure radiation safety and to maintain compatibility between the NRC and the Agreement States in regulating well-logging operations.
- c. Alternatives to rulemaking.
The alternative of maint&ining the status quo was considered and was not adopted because: (1)the current system does not provide legally binding safety requirements, (2)the licensees do not:have a ready reference to the NRC's requirements or any additional amendments, and (3)the current system makes the reciprocity with Agreement States more difficult.
- d. How the issue will be addressed through rulemaking.
A new part (Part 39) will be proposed to address specific radiation safety requirements for well-logging operations.
- e. How the public, industry, and NRC will be affected.
The public would not be affected significantly. Since most of the requirements proposed in the rulemaking are already applied as Enclosure 2
licensing conditions, the increase in cost to the affected licensees from this action would be approximately $80,000 per year for NRC licensees or approximately $500 per licensee per
. year. The NRC would not be affected significantly,
- f. NRC resources and scheduling needed for the rulemaking.
Staff time: 1 man-year. Scheduling: Proposed rule published, 10/84. QUALITY CONTROL EVALUATION:
- 1. Draft regulatory analysis has been prepared and is under Division review.
- 2. Supporting document for 0MB approval will be prepared.
- 3. Congressional Committees will be informed of the action.
- 4. PA will be consulted to determine'whether a public announcement is necessary.
DRAFT RECOMMENDATION: The rulemaking should continue.
\
2 Enclosure 2
v. 4 d'p ucy'o ~g l' UNITED STATES
.,1 j
, * , E NUCLEAR REGULATORY COMMISSION
- WASHINGTON. D. C. 20555 a
%, .....f MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM:
Robert B. Minogue, Director Office of Nuclear Degulatory Research
SUBJECT:
PROPOSED RULE: WELL-LOGGING OPERATIONS (10 CFR 39) Attached 10 CFR Partfor 39. your signature is a notice of proposed rulemaking that would the use of licensed materials in well-logging operations.The new tions imposedo notby them provide licensing specific requirements for well-logging operations butCu conditions. The proposed rule would provide (1) comprehensive and consistent regul applicable to well-logging operations; (2) uniform requirements in NRC and ments designed to reduce the likelihood of accident radioactive August 1982 and sources September in well-logging 1983). operations (5 accidents occurred betwee A new part (Part 39) is proposed for well-logging operations. logging companies use byproduct, source and special nuclear Because well-materials
, if a new part is not proposed, safety requirements would have to be fragmented in Part 30 (byproduct material), Part 40 (source material), and Part 70 (speci nuclear two separate material) parts. and some requirements may have to be repeated at least in the enclosed notice of proposed rulemaking for provided in the "EDO Procedures Manual" at page 11-20b . As 10 a draft entry for the Weekly Report to notify the Commission has been prepare,d for their informa before submitting the proposed rule to the Federal Register (see Enclosu . 't.
Contact:
A. N. Tse, RES 443-7902
7, 9 William J. Dircks 2 Following your approval of this proposed rule, I will notify the appropriate Congressional Committees (see Enclosure 2). Copies of the notice of proposed rulemaking will be distributed to affected licensees and other interested persons oy the Office of Administration. Coordination: The Offices of Nuclear Material Safety and Safeguards, State Programs, Inspection and Enforcement, Administration, Resource Management, Analysis and Evaluation of Operational Data, and the Regions concur in the attached proposed rulemaking for 10 CFR Part 39. The Office of Executive Legal Director has no legal ob pction. The Office of Public Affairs has prepared the draft public announcement (Enclosure 4). Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosures:
- 1. Notice of Proposed Rulemaking
- 2. Draft Congessional Letter
- 3. Draft Weekly Report
- 4. Draft Public Announcement
- 5. D tit Regulatory Analysis
- 6. e - .ft Environmental Assessment Approved for Publication In a final rule published March 19, 1982 (47 FR 11816), the Commission delegated to the EDO (10 CFR 1.40(c) and (d)) the authority to develop and promulgate rules as defined in the APA (5 U.S.C. 551(4)) subject to the limitations in NRC Manual Chapter 0103, Organization and Functions, Office of the Executive i Director for Operations, paragraphs 0213, 038, 039, and 0310.
The enclosed proposed rule entitled " Licenses and Radiation Safety Requirements for Well-logging Operations" would propose specific safety requirements for the j use of licensed materials in well-logging operations. l l l
9 [7590-01] NUCLEAR REGULATORY COMMISSION 10 CFR Parts 19, 20, 21, 30, 32, 39, 40, 51, 70, 71, and 150 Licenses and Radiation Safety Requirements for Well-Logging Operations AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission is proposing a regulation that would specify radiation safety requirements for the use of licensed material in well-logging operations. The proposed regulation would provide: (1) comprehensive and consistent regulations applicable to
~
well-logging operations by consolidating essential radiation safety requirements in a new Part 39, (2) uniform safety requirements in NRC and Agreement States regulations, and (3) safety requirements designed to reduce the likelihood of accidents involving the rupture of radio-active sources in well-logging operations. DATE: Submit comments by (90 days after the publica-tion date). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date. ADDRESS: Submit written comments to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: l 1 Enclosure 1 1
9 [7590-01] Docketing and Service Branch. Copies of comments received on the pro-posed rule may be examined at the NRC Public Document Room, 1717 H Street NW, Washington, DC. FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555,(301)443-7902. SUPPLEMENTARY INFORMATION:
- 1. Introduction Uses of Licensed Material in Well-Logging Operations The oil and gas industry often needs to determine the types and characteristics of the underground formations in a new or existing well.
Licensed materials are used to obtain information on certain properties of an underground formation, such as type of rocks, porosity, hydrocarbon content, and density. Licensed materials are also used for similar purposes in coal or mineral exploration. In well-logging, sealed radioactive sources with associated radia-l tion detectors, known as logging tools, are lowered into a well on a wire-l line. The depth of the well could range from several hundred feet to l greater than 30,000 feet. Information collected by the detectors is sent to the surface through the wireline and plotted on a chart as the logging tool is slowly raised from the bottom of the well. Americium-241 (typi-j cally 0.25 curie to 20 curies) and cesium-137 (typically 2 to 3 curies) I are the radioactive materials most frequently used for this purpose. l 2 Enclosure 1
[7590-01] In subsurface tracer studies, a small amount of radioactive mate-rial in liquid or gaseous form is used. After the liquid or gas tracer is injected into the well, a detector is used in the well to monitor the dispersion of the tracer material. This information will help determine certain underground characteristics such as fluid flow rate and the channeling effect. Iodine-131 (typically 5 to 20 millicuries) is the material most frequently used in subsurface tracer studies. Other licensed materials used in well-logging operations include cobalt-60 used in collar markers, radioactive iron used in nails, uranium used in sinker bars, and iridium-192 used in sands. Collar markers use Co-60 wire (about 1 to 5 microcuries) to mark collars between two sections of casing and provide positive depth measurement. Radioactive iron nails are used to indicate locations of perforations. i Sinker bars are constructed of solid uranium (usually weighing 50 to 100 pounds) and are used to provide additional weight to help push a light weight logging tool through the drilling fluid, called mud by the drill-ing industry, down to the bottom of the well. Sands mixed with small amount of iridium-192 are used to determine the extent of underground hydraulic fracturing.
- NRC and Agreement States' Roles l Twenty-seven Agreement States, including most major oil producing l
States, have assumed responsibility for regulating certain activities, including the use of radioactive materials in well-logging operations, by agreement with the NRC. Each Agreement State issues licenses to per-sons who use radioactive material in well-logging operations in the State. I 3 Enclosure 1 l k
* [7590-01]
The NRC' issues licenses to persons using radioactive materials'in well-logging operations in non-Agreement States. These licenses specify the radiation safety requirements applicable to well-logging operations that the licensee must follow. The NRC has, as of July 1984, 174 licensees authorized to use radioactive materials in well-logging i operations. -The Agreement.. States have approximately 400 licensees involved in well-logging operations. Well-logging licensees from one State frequently perform well-logging jobs in other States. To avoid duplication of licensing effort, NRC' permits, under reciprocity, Agreement State licensees to operate in non-Agreement States according to the conditions of the license issued by their home State. Reciprocity also applies to licensees of the NRC that wish to operate in Agreement States as well as between the dif-ferent Agreement States. Therefore, compatibility between NRC regula-tions and Agreement State regulations .is essential to permit licensees to conduct well-logging operations in various States while maintaining l-a consistent and effective level of protection necessary to ensure public health and safety. I NRC's Current Regulatory Practices Except for requirements concerning the abandonment of irretrievable j well-logging sources set forth in 10 CFR 30.56 and 70.60, current NRC regulations do not provide radiation safety requirements specific to the use of licensed material in well-logging operations. General safety requirements, however, are contained in 10 CFR Parts 20, 30, 40, and 70. At present, NRC reviews a licensee's specific safety program as part of i. 4 Enclosure 1 1 y -
., , c.-- , _ _ - - -. -.,_.s, , , - - - - . - - ~ _ -, -
[7590-01] the license application, and incorporates the safety program into the license as license conditions. Problems with the Current Practice A major problem with the current practice is that radiation safety requirements applicable to the industry are specified as license condi-tions on a case-by-case basis rather than spelled out in uniform regula-tions that are applicable to all licensees. This requires duplication of effort and allows for discrepancies in requirements among specific licenses issued by NRC and the Agreement States. Problems in the con-sistent and uniform application of these requirements could become a greater concern because, under the NRC's program for the decentraliza-tion of material licensing actions, well-logging licenses are issued by the five NRC Regional Offices instead of NRC Headquarters.- Though there are about 50,000 well-logging operations each year, the probability of an accident is small. Nonetheless, accidents have occurred and additional safety requirements are needed to reduce even further the likelihood of an accident. There were five incidents which occurred between August 1982 and September 1983 involving radioactive sources used in well-logging opera-tions. Three incidents involved the rupture of sources in uncontrolled workshop environments by workers performing machining or drilling opera-tions. Two incidents involved the rupture of sources in well holes during logging-tool recovery operations. The cost associated with the cleanup 5 Enclosure 1
\
l 4 [7590-01] l of radioactive contamination from these incidents is estimated to be in excess of 1.5 million dollars. Actions Taken by Agreement States Recognizing the need for comprehensive and consistent radiation safety standards, the Conference of Radiation Control Program Directors established a task force in 1974 to develop necessary standards for well-logging operations. The task force was composed of representatives from States, industry, and Federal agencies, including NRC. By 1981, a set of model regulations was proposed to the Conference by the task force. j In keeping with previous practices of the organization, the Conference adopted the well-logging requirements as Part W of the " Suggested State Regulations for Control of Radiation." Four Agreement States (Arkansas, Kentucky, Oregon,.and Texas) have already adopted Part W requirements as State regulations without significant changes. Several other Agreement States are considering adopting Part W requirements. NRC's Proposed Approach The NRC is proposing to amend its regulations to include specific radiation safety requirements for well-logging operations. These require-ments are included in the proposed 10 CFR Part 39, a new part exclusively dedicated to well-logging operations. The proposed rule is needed for the following reasons: (1) The proposed rule would provide comprehensive and consistent regulations applicable to well-logging operations. Current 6 Enclosure 1
[7590-01] NRC' regulations do not provide specific requirements. Specific requirements pertaining to well-logging operations are imposed as licensing conditions. (2) The proposed rule would incorpurate requirements similar to Part W of the Suggested State Regulations. Four Agreement States have adopted Part W as State regulations and others are considering its adoption. Consistency between NRC and Agree-ment State regulations is essential for well-logging operations because many companies operate in both Agreement and Non-Agreement States. (3) The proposed rule includes safety fequirements designed to reduce the likelihood of incidents involving the rupture of radioactive sources and the spread of radioactive contamina-tion. These incidents may result from operaticns conducted to remove a stuck source from a well-logging device or to retrieve a well-logging device lodged in a well. (4) The proposed rule also includes safety requirements involving l the use of radioactive collar markers, uranium sinker bars, i and of a sealed source in a well without surface casing. If these requirements are adopted as final regulations, NRC would i encourage the Conference of Radiation Control Program Directors and the i l l l l 7 Enclosure 1 i
[7590-01] Agreement States to adopt similar requirements in order to achieve compatible regulations. A new part (10 CFR Part 39), dedicated exclusively to well-logging operations, is proposed to specify the various safety requirements. A new part is needed because these operations use byproduct material, source material, and special nuclear material. If these safety require-ments were not included in one part, they would have to be repeated in Parts 30 (byproduct material), 40 (source material) and 70 (special nuclear material). For instance, the existing regulation on irretriev-able well-logging sources is repeated in Parts 30 and 70 for sources containing byproduct material and special nuclear material, respectively. Furthermore, if the safety requirements were fragmented throughout Parts 30, 40, and 70, licensees, NRC licensing reviewers, and NRC inspec-ti rs could have difficulty in determining the regulations applicable to a specific situation.
- 2. Discussion of the Proposed Rule The proposed Part 39 would prescribe specific safety requirements for well-logging operations that use licensed materials. General provi-sions in Parts 30, 40 and 70, such as renewal, amendment or termination of licenses, would also be applicable to well-logging licensees. The l
l following sections provide a discussion of the major provisions of the l proposed Part 39. 8 Enclosure 1 i
[7590-01] A. Agreement with Well Owner or Operator The proposed rule (S 39.15) would require that a licensee (a well-logging company) enter into a written agreement with a well owner or operator, whichever engaged the licensee to perform the well-logging operations, before the licensee could use sealed sources in well-logging. The requirement to enter into a written agreement on abandonment proce-dures for irretrievable well-logging sources was published as a final rule in the Federal Register (10 CFR 30.56, 70.60, and 150.20) on August 29, 1983 (48 FR 39036). The proposed Part 39 has incorporated the existing requirement for an agreement and proposes to remove SS 30.56 and 70.60 and to modify S 150.20. The proposed rule specifies the terms of this agreement. The well owner or operator would agree, if a sealed source is lodged in the well, to: (1) make a reasonable effort to recover the sealed source; (2) not permit specific types of recovery operations that could endanger the integrity of the sealed source; (3) not release contaminated equipment
? or areas, such as areas surrounding the well, for unrestricted use unless the equipment or the area has been decontaminated (guidance on release of equipment or areas for unrestricted use is available on a case-by-case basis from the NRC staff, in general, limits similar to those in Regula-tory Guide 1.86, " Termination of Operating Licenses for Nuclear Reactors,"
should be met.); and (4) implement specified abandonment procedures when l a sealed source is deemed irretrievable. The sealed source lodged in the well must be retrieved or properly abandoned to avoid possible source I rupture by subsequent re-entry into the well. This requirement is needed because the licensee (the well-logging company) may not have the legal authority or resources to recover a tool ! 9 Enclosure 1 l
[7590-01] and its sealed source if it becomes lost in a well. The well owner or operator controls the overall coordination of activities at the well. When a tool containing a sealed source is lost in the well, the well owner or operator could engage a " fishing company" to recover it. The fishing company is usually responsible directly to the well owner or operator. The licensed well-logging company has no legal right to direct or control the activity of the fishing ccmpany. Therefore, the contractual agreement between the licensee and the well owner or opera-tor is necessary to obligate the well owner or operator to (1) recover the sealed source in a safe manner, (2) properly abandon an irretrievable source, and (3) prevent release of contaminated equipment or areas until they have been decontaminated. It should be noted that the NRC is making the licensee responsible for the sealed source during well-logging until the sealed source is removed from the temporary jobsite or the completion of the abandonment procedures, if the source is determined to be irretrievable. Thus, NRC is making the licensse responsible for ensuring compliance with the regu-lations or for pursuing every legal avenue, based on the written agree-ment, to achieve compliance. The written agreement could assign to the well owner or operator, under the supervision of the licensee in areas of radiation safety, the responsibility for carrying out the recovery operations or abandonment procedures. However, the written agreement could not transfer the possession of the sealed source from one party to another without specific NRC approval. The Commission considered another approach to allocate responsibil-ity among the various parties involved in the well-logging operations. It would have provided a general license to the well owner or operator, 10 Enclosure 1
[7590-01] whichever engaged the well-logging company. Under this approach, NRC would have imposed the same safety requirements as would be contained in the written agreement directly on the party that had the authority to-fulfill these requirements. This alternative was not pursued for the following reasons: (1) Current industry practice, of having written agreements between licensees and well owners or operators, has worked satisfactorily for the last 20 years; (2) The well-logging company is in a better position to handle radiological problems than the well owner or operator, unless the latter's personnel are also properly trained, which would be duplicative and costly; , (3) Licensing well owners or operators, as well as well-loggers may create confusion about who is responsibile for radiological safety when the sealed source enters or leaves the the well. The Commission is interested in ccmments on the costs, advantages and disavantages of the proposed approach and on the alternative. i B. Radiation Detection Instruments The proposed rule (S 39.33(a)) would require that a licensee have a radiation survey instrument at each field station and at each temporary jobsite. These survey instruments are needed to perform routine radiation surveys and to measure for any potential radioactive contamination. Each 11 Enclosure 1 we r u-
[7590-01] survey instrument would have to be capable of measuring 0.1 milliroentgen per hour through at least 100 milliroentgens per hour. The requirement of 100 milliroentgens per hour is proposed because a licensee occasionally needs to define the boundaries of a high radiation area as required by 10 CFR 20.203(c)(2). A grandfather clause (for a period of 5 years) is provided for existing survey instruments capable of measuring 0.1 milli-roentgen per hour through at least 20 milliroentgens per hour to reduce the economic impact on licensees. A 5 year period is proposed because the average life of a field-use survey instrument is estimated to be 5 years. Although the required radiation survey instruments are adequate for
- routine radiation surveys, they are not designed to handle unlikely events such as the rupture of a sealed source resulting in low-level contamina-
, tion of americium-241 in the drilling fluid or mud. Therefore, the pro-posed rule would also require that a licensee have available, when needed, radiation detection instruments (for example, a hign range survey meter or a sodium iodide crystal detector) that are capable of measuring radia-tion levels or contamination levels which could be encountered during an accident. For example, before the initiation of recovery of an americium-241 source from a well, the licensee would have to have an instrument present at the jobsite that is sensitive enough to detect americium-241 contamination. Other types of accidents could also result in high radiation levels; thus, a high range survey meter may be needed. The licensee could own the instrument or use a consulting service that has such an instrument. A 6-month calibration interval would be specified for each survey instrument. This interval is adequate, based on licensing experience, 12 Enclosure 1
[7590-01] to ensure the proper operation of the instrument and is consistent with practices presently required in well-logging licenses. C. Leak Testing of Sealed Sources The proposed rule (S 39.35) would require that sealed sources be leak tested at least every 6 months. Because these sources are subjected to rough handling and severe environmental conditions in a well, it is necessary that they maintain their integrity. A leaking sealed source, if undetected, could cause extensive radioactive contamination to the well, equipment, personnel, and environment. The leak test requirement is consistent with the current requirement for well-loggers and many other types of licensees. Several exemptions are provided in the proposed rule to reduce the burden of leak testing on the industry. The sealed sources exempted from leak testing requirements are those that would present essentially no hazard to the public or the environment in the event of a leak because they contain either gaseous, short lived, or small quantities of radio-active materials. D. Physical Inventory The proposed rule (S 39.37) would require that a semi-annual physical inventory be made to account for sources of licensed material. This re-quirement is needed because the sources used in well-logging operations are frequently transported to and from temporary jobsites. An accurate account of each of the sources would ensure that no source has been lost. The 6-month period is proposed because a licensee could conduct a physi-cal inventory and leak testing at the same time, thus, reducing its burdens. I 13 Enclosure 1
[7590-01] E. Desian and Performance Criteria for Sealed Sources Design and performance criteria are proposed in S 39.41(a) for all sealed sources except those containing gaseous licensed material. These have been proposed as minimum requirements, and are the same (except for the pressure test) as the requirements -for well-logging sources in industry standard ANSI N542, " Sealed Radioactive Sources, Classification," published by the National Bureau of Standards (NBS Handbook 126) in 1978. However, sealed sources used in well-logging are subject to more severe environmental conditions, such as high pressure and high tempera-ture. Therefore, several additional' requirements are proposed to provide further assurances that, under accident conditions, the source is.unlikely to lose its integrity. These requirements would specify that each indi-vidual sealed source would have to (1) pass a pressure test (2) be doubly encapsulated; and (3) contain licensed material in chemical and physical forms which are as insoluble and nondispersible as practical. A singly encapsulated source has a greater chance of causing radioactive contamina-tion than a doubly encapsulated source, and soluble or dispersible mate-rial from a ruptured source could cause more radioactive contamination than less soluble, less dispersible material. These requirements would (1) phase out the use of substandard sources in well-logging, (2) result in less chance of source rupture in the well, and (3) reduce the conse-quence of contamination in the event of a rupture. The proposed rule would require th'at a licensee not use a new sealed source manufactured after [1 year after the effective date of the final rule] unless it is designed and manufactured in accordance with proposed S 39.41(a). The 1 year grace period is proposed to provide sealed source 14 Enclosure 1
4 [7590-01] manufacturers sufficient time to produce sources complying with NRC's requirements. Sealed sources manufactured before [1 year after the effective date of the final rule] could be used by a licensee until [2 years after the effective date of the final rule]. After this 2 year period, however, these sources could no longer be used unless they were certified, by the manufacturer or other testing orginization, as having satisfied the requirements specified in S 39.41(b). Any source that could not meet the performance criteria proposed in 5 39.41(b) would have to be phased out of well-logging. Most sealed sources manufactured after 1968 have complied with the ANSI Standard and there should not be a problem in their ability to comply with the require-ments specified in S 39.41(b). F. Inspection, Maintenance, and Opening of Source or Source Holder The proposed rule (S 39.43(a)) would require that each licensee inspect equipment and tools for obvious defects before the equipment is used each day. Furthermore, paragraph (b) would require that each licensee inspect and maintain equipment and tools at invervals not to exceed 6 months. The licensee would be required to check the equipment and tools for label legibility and for the absence of physical damage. . If any equipment or tools critical to radiation safety were found to be worn or damaged, paragraph (c) would require that the licensee remove them from service until repairs were made. Paragraph (d) of this section would prohibit the licensee from per-forming maintenance on a sealed source or a source holder containing a source, unless the licensee has a written instruction approved by NRC. 15 Enclosure 1
[7590-01] This maintenance may include changing the 0-ring on the source holder containing a source or changing the sealed source from one source holder i to another source holder. This requirement is needed because the worker-t is very close to the sealed source during this maintenance, and thus, could receive a significant radiation dose. This section would also prohibit a licensee from forcing a stuck sealed source out of the source holder or out of the logging tool by operations that could endanger its integrity unless specifically author-ized by the NRC. Prohibited operations could include, but would not be limited to: drilling, cutting, or chiseling. These operations would be
~
prohibited because they could accidently rupture the sealed source and { could cause radioactive contamination of the facility, personnel and l- environment. For similar reasons, a licensee would be prohibited from repairing, opening, or modifying a sealed source unless specifically authorized by NRC to perform these operations, j G. Subsurface Tracer Studies Radioactive materials in liquid or gaseous forms and other materials, such as sand labeled with radionuclides, are used as tracer materials in subsurface tracer studies. These materials could accidently spill on clothing, contaminate hands, be ingested, or, in the case of gaseous or volatile material, be inhaled by personnel. The proposed rule (S 39.45) ] would require that protective gloves, clothing, and other equipment be-used by individuals who handle tracer materials. When volatile materials' L such as iodine-131 are handled, a bioassay could be required when indi- - l viduals work in field operations with more than 50 millicuries of I-125 . or I-131. A licensee would also be required to maintain the temporary 16 Enclosure 1 4
= , . . - , . , . -,c,-- ,,c ,__,7,,.--,,--..,-,,.% ,.~_--,.,m,,,-,.-~_- _-,.-. ,,-,4 -w,,,y,- -,-r- .-_v-,-. . -., s.---
[7590-01] jobsite and the field station free from contamination from licensed materials. In addition, a licensee would not be allowed to inject any licensed material into a fresh water aquifer as part of a subsurface tracer study because the water could be used for human or animal consumption or to irrigate crops. H. Radioactive Markers The proposed rule (S 39.47) would prohibit the use of radioactive markers (used for determining the depth of a well), unless the radioactiv-ity of each marker, at the time of installation, is less than the quantity specified in S 30.71, Schedule B. This limitation in the amount of radio-activity is necessary because it is impracticable for the licensee that installs the radioactive marker to recover the marker when the well owner or operator removes the well casings from the well at a later date. I. Uranium Sinker Bars The proposed rule (S 39.49) would require that after [one year from effective data of the final rule] each uranium sinker bar (used as a weight to pull a logging tool toward the bottom of a well) bear a legend:
" Caution - Radioactive Material - Uranium" and " Notify Civil Authorities or (company name) If Found." This requirement is needed to ensure that, if a uranium sinker bar is lost, someone who finds the bar could identify it as radioactive and would return it to the company. (Because uranium is source material, the licensee must also comply, as necessary, with requirements in 10 CFR Part 40, " Domestic Licensing of Source Materials.")
17 Enclosure 1
[7590-01] J. Use of Sealed Source in a Well Without Surface Casing The proposed rule (S 39.51) would prohibit the use of a sealed source in a well without surface casing unless procedures for protecting fresh water aquifer zones are specifically approved by NRC. (A surface casing is a pipe or tube used as lining in the well to isolate the fresh water zone from the well). The purpose of this requirement is to mini-mize the possibility of contamination of fresh water aquifer zo.nas by accidental rupture of a sealed source. In general, most wells have sur-face casings to prevent oil or other particulates from entering these zones. However, if surface casings cannot be placed, a licensee may not use a sealed source in an uncased well, unless NRC has specifically approved the licensee's procedures for providing adequate protection of the fresh water aquifer from radioactive contamination. Because most uncased wells are primarily encountered in mineral logg-ing, licensees performing mineral logging operations may want to provide specific comments on this requirement, especially on the feasibility of protective alternatives. K. Training Although general requirements on instruction and training are speci-fied in 10 CFR 19.12 and 30.33(a)(3), the proposed rule (S 39.61) would , establish specific training requirements for logging supervisors and logg-ing assistants. Licensees would be prohibited from permitting an indi-vidual to perform well-logging operations unless the individual has been properly trained in accordance with the requirements specified in this section. Training is needed to provide radiation workers with sufficient knowledge and practical experience on radiation safety to ensure safe use 18 Enclosure 1
[7590-01] of licensed materials. The level of knowledge they would need would depend, of course, on their responsibilities. For logging supervisors, the proposed rule would require, at a mini-mum, 40 hours of formal classroom training in the subjects listed under 939.61(e). Furthermore, it would require that an individual must have, at a minimum, 3 months of on-the-job training. This requirement is needed to ensure that a logging supervisor has sufficient practical experience on radiation safety procedures to handle routine operations and unanticipated emergencies in a safe manner. Because logging assistants work under the personal supervision of a logging supervisor, their training requirements can be less stringent than those for the logging supervisors. The proposed rule would require that an assistant be instructed on applicable sections of Parts 19, 20, and 21, and on the licensee's operating and emergency procedures. It would also require that the individual be able to use remote tools, survey instruments, etc., to perform work properly under the supervision of the logging supervisor. The proposed rule would also require that logging supervisors and logging assistants be retrained annually after their initial training. This periodic retraining is needed to: (1) refresh their understanding o of basic radiation safety practices, (2) instruct them on any new proce-dures or on the use of new radiation detection instruments and new tools, and (3) review regulatory requirements or new regulations which may affect their work. 19 Enclosure 1
~- ,
-o [7590-01]
L. Operating and Emergency Procedures The proposed rule (S 39.63) would require that each licensee develop and follow written procedures for well-logging operations and for dealing with emergencies. These written procedures would also be used as: (1) training materials for instructing logging supervisors and logging assistants, (2) reference materials at a field station and at a temporary jobsite, and (3) supporting documents in licensing applications. M. Personnel Monitoring and Radiation Surveys The proposed rule (S 39.65) would require that logging supervisors and logging assistants wear personnel monitoring equipment at all times during the well-logging operation. The requirements in 6 39.65(a),
. (b) and (c) are specific applications of the existing broader requirements in SS 20.108, 20.202, and 20.401, respectively. These requirements are repeated in this part because they constitute key features of a radiation protection program.
Similarily, the proposed rule (S 39.67) would also require that the licensee conduct radiation surveys. This requirement is a specific appli-cation of the existing broader requirement in S 20.201, " Surveys." If gaseous or volatile tracer materials are used, the licensee may be required to provide bioassay service to individuals handling the tracer materials ($ 39.65(b)). Whether a bioastay is needed depends on the type of radioactive materials and quantity used. For example, Regu-latory Guide 8.20, " Applications of Bioassay for I-125 and I-131," states that bioassays should be performed when individuals work in field opera-tions with more than 50 millicuries of I-125 or I-131. 20 Enclosure 1
s [7590-01] N. Contamination Control The proposed rule (9 39.69) would require that licensees monitor for radioactive contamination during fishing or source recovery operations, initiate emergency procedures if a sealed source ruptures, and decontami-nate any equipment, personnel, or environment that is contaminated. This requirement is needed to assure that any rupture of a sealed source in a well during a fishing operation is detected and reported and that emer-gency procedures are initiated. Also, paragraph (c) would reqaire that the licensee decontaminate any contaminated equipment, areas, or personnel. Guidance on release of equipment or areas for unrestricted use is avail-able case-by-case from the NRC. In general, limits similar to those in Regulatory Guide 1.86 should be met. The licensee may perform the decon-tamination or use a contracting or consulting service to perform it. These requirements are important to avoid the possibility of unnecessary wide-spread contamination if a sealed source is ruptured. The monitoring would detect contamination from a source rupture and the initiation of emergency procedures would limit the spread of contamination. Further-more, decontamination would prevent contaminated objects from leaving the site and thus further prevent wide-spread contamination to public areas. O. Security The proposed rule (6 39.71) would require that the licensee main-tain surveillance and control of the jobsite's restricted areas (as defined in Part 20) and prevent unauthorized personnel, such as employees of an oil company or drilling company, from entering a restricted area. This requirement is needed to avoid the inadvertent exposure of these personnel to radiation. 21 Enclosure 1
- [7590-01] !
P. Documents and Records Required at Field Stations and Temporary Jobsites The proposed rule ($$ 39.73 and 39.75) would require that certain documents and records'be kept at a field station or a temporary jobsite. These records are needed so that operating personnel can have easy access to the documents they need to perform the job, to follow any operational restrictions, or to use emergency procedures if an accident occurs. Records of radiation surveys, instrument calibrations, sealed source leak tests, etc., are needed for the licensee to make safety checks or to check schedules for maintenance. The recordkeeping requirement would also enable NRC inspectors to determine whether the requirements have been met. Q. Notification of Incidents and Lost Sources and Abandonment Procedures for Irretrievable Sources . The proposed rule ($ 39.77(a)) would require, in addition to general reporting requirements in Part 20, immediate notification if (1) licensed material has been lost in or near freshwater aquifers or (2) a sealed source has been ruptured at the licensee's facility or temporary jobsite. This requirement is needed because these conditions could cause radio-active contamination. Paragraph (b) would also require that the licensee notify NRC of incidents and lost sources. (This does not include loss of a sealed source lodged in a well because it is covered by paragraph (c) of this section). The requirements are presently contained in a more general form in SS 20.402, 20.403, and 20.405 and are repeated in specific form for the sake of completeness. 22 Enclosure 1
= l o [7590-01] Paragraphs (c) and (d) consolidate the existing regulations, 10 CFR 30.56 and 70.60, on irretrievable well-logging sources into one section in Part 39. -The consolidation would be beneficial because it would put all requi"ements for well-logging operations in a single part. The
,n r6,no.c e d text is essentially the same as the existing text under $$ 30.56 and 70.60, which would be deleted.
R. Application for Exemption The proposed rule (S 39.91) would permit a licensee to apply for an exemption from the requirements in this part. This section is needed to allow NRC to judge on a case-by-case basis whether certain requirements can be waived if if determines that the exemption will not result in undue hazard to life or property.
- 3. Summary The Commission believes that the proposed rule, if adopted, would provide a comprehensive and consistent set of regulations that help maintain compatibility between NRC's and Agreement State's regulations.
Furthermore, the proposed rule would also establish additional require-ments that would reduce the potential for and severity of an accident. The Commission also believes that the economic impact of the rule would be small. The economic impact is analyzed in detail in a draft regula-tory analysis prepared on this proposed rule. Interested persons are encouraged to comment on the proposed rule, on its impact on the public and the industry, and on the draft regulatory analysis. 23 Enclosure 1 o
[7590-01] FINDING OF NO SIGNIFICANT ENVIRONMENTAL IMPACT: AVAILABILITY The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations.in Subpart A of 10 CFR Part 51, that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and therefore an environmental impact statement is not required. This rule would not significantly affect the quality of the human environment because the proposed requirements are designed to control the use of licensed materials in well-logging operations. On the other hand, these requirements, if adopted, would reduce occupational radiation exposures and would also reduce the chances for and consequences of accidents involving licensed materials. Futhermore, most of these > requirements are already being complied with by licensees as licensing conditions. Therefore the proposed rule would have no measurable nega-tive environmental impact. The environment assessment and finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room, 1717 H Street NW, Washington, DC. Single copies of the environmental assessment and finding of no significant impact are available from Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555 (301-443-7902). PAPERWORK REDUCTION ACT STATEMENT This proposed rule contains new information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 24 Enclosure 1
o [7590-01] et seq.). It has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements. REGULATORY ANALYSIS The Commission has prepared a draft regulatory analysis on this pro-posed regulation. The analysis examines the costs and benefits of the . alternatives considered by the Commission. The draft analysis is avail-able for inspection in the NRC Public Document Room, 1717.H Street, NW, Washington, DC. Single copies of the analysis may be obtained from Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555 (301-443-7902). The Commission requests public comment on the draft analysis. Comments on the draft analysis may be submitted to the NRC as indicated under the 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 upon a substantial number of small entities. The proposed rule would provide radiation safety requirements, uniformity in the NRC and Agreement States regulations, and requirements that would reduce the frequency of accidents involving radiation or radioactive materials. The proposed rule affects about 174 specific licensees of which approximately 60% are small entities based on the size standards of the Small Business Administration set out in 13 CFR 25 Enclosure 1
[7590-01] Part 121 (February 9, 1984, 49 FR 5024). These licenses are issued to companies performing well-logging operations. The Commission estimates that the total cost of compliance with the requirements contained in this proposed regulation would be approximately
$7,400 a year for an average well-logging licensee. However, many well-logging licensees are already complying with most of these requirements because the requirements are currently imposed as conditions of the license under which they operate. Therefore, the actual increase in the compliance cost to most licensees would be considerably smaller. The cost to an average well-logging licensee for those requirements not already imposed under a license condition would be approximately $2,000 a year.
The Commission does not believe that this regulation would impose a significant economic impact on most licensees. A detailed analysis of the cost of each individual requirement imposed by the regulation appears in the Regulatory Analysis prepared for this action. The Commission is particularly interested in receiving comment from well-logging licensees on the cost estimates contained in the Regulatory Analysis and on the assumptions on which these estimates are based. The Commission is also interested in receiving comment from small licensees about the potential impact of the proposed regulation and the resultant cost of these require-ments on their operations. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disporportionate adverse economic impact should notify the Commission of this in a comment that indicates the following: 26 Enclosure 1
C' [7590-01] (a) The licensee's size in terms of annual income or revenue, number of employees, number of well-logging trucks, and average number of wells logged or serviced annually; (b) How the proposed regulation would result in a significant economic burden upon the licensee as compared to that on a larger licensee; and (c) How the proposed regulations could be modified to take into account the licensee's differing needs or capabilities. LIST OF SUBJECTS IN 10 CFR PARTS 19, 20, 21, 30, 32, 39, 40, 51, 70, 71, 150 Part 19 - Environmental protection, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements, Sex discrimination. Part 20 - Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packag-ing and containers, Penalty, Radiation protection, Reporting and record-keeping requirements, Special nuclear material, Source material, Waste treatment and disposal. Part 21 - Nuclear power plants and reactors, Penalty, Radiation protection, Reporting and recordkeeping requirements. Part 30 - Byproduct material, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Penalty, Radiation protection, Reporting and recordkeeping requirements. Part 32 - Byproduct material, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting and recordkeeping requirements. 27 Enclosure 1
~ . [7590-01]
Part 39 - Byproduct material, Nuclear material, Oil and gas exploration - well logging, Penalty, Reporting and recordkeeping require-ments, Scientific equipment, Security measures, Source material, Special nuclear material. Part 40 - Government contracts, Hazardous materials-transportation, Nuclear materials, Penalty, Reporting and recordkeeping requirements, Source material, Uranium. Part 51 - Administrative practice and procedure, Environmental impact statement, Nuclear materials, Nuclear power plants and reactors, Reporting and recordkeeping requirements. Part 70 - Hazardous materials - transportation, Nuclear materials, Packaging and containers, Penalty, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment, Security measures, - Special nuclear material. Part 71 - Hazardous materials - transportation, Nuclear materials, Packaging and containers, Penalty, Reporting and recordkeeping requirements. Part 150 - Hazardous materials - transportation, Intergovernmental relations, Nuclear materials, Penalty, Reporting and recordkeeping require-ments, Security measures, Source material, Special Nuclear material. 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 l of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt 10 CFR Part 39. l l 28 Enclosure 1 i s
[7590-01]
- 1. Part 39 is added to 10 CFR Chapter I to read as follows:
PART 39--LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL-LOGGING OPERATIONS SUBPART A - GENERAL PROVISIONS Sec. 39.1 Purpose and scope. 39.2 Definitions. 39.5 Interpretations. 39.8 Information collection requirements: OMB approval. SUBPART B - SPECIFIC LICENSING REQUIREMENTS 39.11 Application for a specific license. 39.13 Specific licenses for well-logging operations. 39.15 Requirement for an agreement with well owner or operator. 39.17 Request for written statements. SUBPART C - EQUIPMENT CONTROL 39.31 Labels, security and transportation precautions. 39.33 Radiation detection instruments. 39.35 Leak testing of sealed sources. 39.37 Physical inventory. 29 Enclosure 1
[7590-01] 39.39 Utilization records. 39.41 Design and performance criteria for sealed sources. 39.43 Inspection, maintenance, and opening of a source or source holder. 39.45 Subsurface tracer studies. 39.47 Radioactive markers. 39.49 Uranium sinker bars. 39.51 Use of a sealed source in a well without surface casing. SUBPART 0 - RADIATION SAFETY REQUIREMENTS 39.61 Training. 39.63 Operating and emergency procedures. 39.65 Personnel monitoring. 39.67 Radiation surveys. 39.69 Radioactive contamination control. SUBPART E - SECURITY, RECORDS, NOTIFICATIONS 39.71 Security. 39.73 Documents and records required at field stations. 39.75 Documents and records required at temporary jobsites. 39.77 Notification of incidents and lost sources; abandonment procedures for irretrievable sources. i 30 Enclosure 1
[7590-01] . SUBPART F - EXEMPTIONS 39.91 Applications for exemptions. ' SUBPART G - ENFORCEMENT 39.101 Violations. AUTHORITY: Sections 53, 57, 62, 63, 65, 69, 81, 82, 161, 182, 183, 186, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2092, 2093, 2095, 2099, 2111, 2112, 2201, 2232, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846). For purposes of sec. 223, 68 Stat. 958 as amended (42 U.S.C. 2273); SS 39.15, 39.31-39.51, 39.61-39.77 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and SS 39.15, 39.33-39.43, 39.61-4 39.67, 39.73-39.77 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)). 1 31 Enclosure 1
. [7590-01]
SUBPART A - GENERAL PROVISIONS 1 6 39.1 Purpose and scope. (a) This part prescribes requirements for the issuance of a license authorizing the use of licensed materials including sealed sources, radio-active tracers, radioactive markers, e.nd uranium sinker bars, in well-logging operations in a single well. This part also prescribes radiation safety requirements for persons using licensed materials in these opera-tions. The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In parti-cular, the provisions of Parts 19, 20, 21, 30, 40, 70, 71, and 150 of this chapter apply to applicants and licensees subject to this part. (b) The requirements set out in this part do not apply to the issu-ance of a license authorizing the use of licensed material in tracer studies involving multiple wells, e.g. , field flooding studies. S 39.2 Definitions.
" Casing" means a metal pipe or tube used as a lining for oil or gas wells to prevent collapse of the well-bore.
" Field station" means a facility where licensed material may be :5tored
- or used and from which equipment is dispatched to temporary jobsites.
" Fresh water aquifer," for the purpose of this part, means a geo-logical formation that is capable of yielding a significant amount of fresh water to a well or spring.
" Injection tool" means a device used for controlled subsurface injection of radioactive tracer material.
32 Enclosure 1
. i
[7590-01]
" Irretrievable well-logging source" means any sealed source con-taining licensed material that is pulled off or not connected to the wireline that suspends the source in the well and for which all reason-able effort at recovery has been expended.
" Licensed material" means byproduct material, source material, or special nuclear material received, possessed, used, or transferred under a license issued by the Commission under the regulations in this chapter.
" Logging assistant" means an individual who assists the logging supervisor in performing the well-logging operations.
, " Logging supervisor" means an individual who provides personal supervision of the use of licensed material at the temporary jobsite and who is responsible to the licensee for assuring compliance with the requirements of the Commission's regulations and the conditions of the license.
" Logging tool" means a device used subsurface to perform well-logging.
" Mineral logging" means any logging performed for the purpose of mineral exploration other than oil or gas.
" Personal supervision" means guidance and instruction by a logging supervisor who is physically present at the temporary jobsite and in j such proximity that personal contact with the logging assistants is maintained and that immediate assistance can be given.
" Radioactive marker" means licensed material used for the purpose of depth determination or direction orientation. This term includes radioactive collar markers and radioactive iron nails.
" Sealed source" means any licensed material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.
i , 33 Enclosure 1
[7590-01] j i
" Source holder" means a housing or assembly into which a sealed source is placed for the purpose of facilitating the handling and use of the source in well-logging operations.
" Subsurface tracer study" means, for the purpose of this part, the release of unsealed licensed material or a substance labeled with licensed material in a single well for the purpose of tracing the move-ment or position of the material or substance in the well-bore or adjacent formation (this term does not include the use of licensed mate-erial in field ficoding studies).
" Surface casing" means a pipe or tube used as a lining in a well to isolate the fresh water zone from the well.
" Temporary jobsite" means a place to which licensed materials are dispatched to perform well-logging operations or subsurface tracer studies.
" Uranium sinker bar," for the purpose of this part, means a weigh't containing uranium used for the purpose of providing additional force to pull a logging tool down toward the bottom of a well.
"Well-bore" means a drilled hole in which well-logging operations and subsurface tracer studies are performed.
"Well-logging" or " wireline service operation," for the purpose of this part, means the lowering and raising of measuring devices or tools which contain licensed material into well-bores or cavities for the purpose of obtaining information about the well or adjacent forma-tions which may be used in oil, gas, mineral, or geological exploration.
"Well-logging operation" means any activity involving licensed material performed in a well, including well-logging, mineral logging, l
34 Enclosure 1
[7590-01] subsurface tracer studies, use of radioactive markers, radioactive iron nails, uranium sinker bars, and radioactive sands.
" Wireline" means a cable containing one or more electrical conduc-tors which is used to lower and raise logging tools in the well-bore.
S 39.5 Interpretations Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpreta-tion by the General Counsel will be recognized to be binding upon the Commission. S 39.8 Information collection requirements: OMB approval. (a) The Nuclear Regulatory Commission has submitted the informa-tion collection requirements contained in this part to the Office of Management and Budget (0MB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements contained in this part under con-trol number 3150- . (b) The approved information collection requirements contained in this part appear in SS 39.11, 39.13, 39.15, 39.31, 39.33, 39.35, 39.37, 39.39, 39.41, 39.43, 39.49, 39.61, 39.65, 39.67, 39.73, 39.75, and 39.77. 35 Enclosure 1
[7590-01] SUBPART B - SPECIFIC LICENSING REQUIREMENTS
$ 39.11 Application for a specific license.
A person, as defined in S 30.4(k) of this chapter, shall file an application for a specific license authorizing the use of licensed mate-rial in well-logging operations on Form NRC 313, " Application for Mate-rial License." Each application for a license, other than a license exempted from Part 170 of this chapter, must be accompanied by the fee prescribed in S 170.31 of this chapter. The application must be sent to the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. S 39.13 Specific licenses for well-logging operations. The Commission will approve an application for a specific license for the use of licensed material in well-logging operations if the applicant meets the following requirements: (a) The applicant shall satisfy the general requirements specified in S 30.33 of this chapter for byproduct material, in S40.32 of this chapter for source material, and in S 70.33 of this chapter for special nuclear material, as appropriate, and any special requirements contained in this part. l l (b) The applicant shall develop a program for training logging ! supervisors and logging assistants and submit to the Commission a sched-ule or description of this program which specifies the-- (1) Initial training; (2) Annual retraining; (3) On-the-job training; 36 Enclosure 1 h
[7590-01] (4) Means the applicant will use, including a copy of the written test, to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the Commission's regulations and licensing requirements, and the applicant's operating and emergency procedures; and (5) Means the applicant will use, including a copy of the written test or an outline of the oral test, to demonstrate the logging assistant's knowledge and understanding of and ability to comply with, the applicant's operating and emergency procedures. (c) The applicant shall establish and submit to the Commission a written operating and emergency procedures as described in 6 39.63. (d) The applicant shall establish and submit to the Commission a program for annual internal inspections of the performance of each log-ging supervisor and assistant to ensure that the Commission's regulations, license requirements, and the applicant's operating and emergency proce-dures are followed by these personnel. Inspection records must be retained for 3 years after each annual internal inspection. (e) The applicant shall submit a description of its overall organi-zational structure pertaining to the well-logging operations, including specified delegations of authority and responsibility. (f) (1) If the applicant wants to conduct and evaluate its own leak tests, it shall establish procedures to be followed in leak testing sealed sources for possible leakage and contamination and submit a description of these procedures to the Commission. The description must include the-- (i) Instrumentation to be used; (ii) Method of performing test; and (jii) Pertinent experience of the person who will perform the test. 37 Enclosure 1
. [7590-01]
(2) If an applicant wants to use a leak test kit, it shall identify the manufacturer and the model number of the kit. S 39.15 Requirement for an agreement with well owner or operator. (a) A licensee shall not perform well-logging with a sealed source unless it executes a written agreement with the well owner or operator, whichever engaged the licensee to perform the well-logging operation. The licensee shall retain a copy of the written agreement for 3 years after the completion of the well-logging operation. (b) This written agreement must specify that: (1) If a sealed source becomes lodged in the well, a reasonable effort will be made to recover it; (2) A person may not attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture; (3) If the environment or if any equipment or personnel are contami-nated with licensed material, they must be decontaminated before release from the site or release for unrestricted use; and (4) If, after reasonable efforts at recovery have been expended, the sealed source is classified as irretrievable, the following require-ments must be implemented within 30 days after a sealed source is classi-fied as irretrievable: l (i) Each irretrievable well-logging source must be immobilized and i sealed in place with a cement plug; (ii) A whipstock or other deflection device must be set at some point in the well above the cement plug, unless the cement plug and source are not accessible to any subsequent drilling operations; and I i l 38 Enclosure 1
[7590-01] (iii) A permanent identification plaque, constructed of long lasting material such as stainless steel, brass, bronze, or monel, must be mounted at the surface of the well, unless the mounting of the plaque is not practical. The size of the plaque must be at least 7-inches square and 1/8-inch thick. The plaque must contain-- (A) The word " CAUTION"; (B) The radiation symbol (the color requirement in S 20.203 of this chapter need not be met); (C) The date the source was abandoned; (0) The name of the well owner or well operator, as appropriate; (E) The well name and well identification number (s) or other designation; (F) An identification of the sealed source (s) by radionuclide and quantity; , (G) The depth of the source and depth to the top of the plug; and (H) An appropriate warning such as "00 NOT RE-ENTER THIS WELL." (c) A licensee may apply under S 39.91 for Commission case-by-case approval of proposed procedures to abandon an irretrievable well-logging source-in a manner not otherwise authorized in paragraph (b)(4) of this section. S 39.17 Reouest for written statements. Each license is deemed to contain the condition that the licensee will, at any time before expiration of the license, upon the Commission's request, submit written statements, signed under oath or affirmation, to enable the Commission to determine whether or not the license should be modified, suspended, or revoked. 39 Enclosure 1 l-
. [7590-01]
SUBPART C - EQUIPMENT CONTROL 9 9 39.31 Labels, security and transoortation precautions. (a) Labels. (1) The licensee may not use a source, source holder, or logging tool containing licensed material unless it bears a durable, legible, and clearly visible marking or label. The label must contain the radiation symbol specified in S 20.203 of this chapter, without the conventional color requirements, and the wording " DANGER (or CAUTION) RADI0 ACTIVE MATERI AL. " The label must be on the smallest component that contains the licensed material transported as a separate piece of equipment. (2) The licensee may not use a storage or transport container to store or transport licensed material unless it has permanently attached to it a. durable, legible, and clearly visible label. The label must contain the radiation symbol, in conventional colors, and the wording
" CAUTION (or DANGER), RADI0 ACTIVE MATERIAL, NOTIFY CIVIL AUTHORITIES (or NAME OF COMPANY)."
(b) Security precautions during storage and transportation. (1) The licensee shall store each source containing licensed mate-rial in a storage container or transportation package. The container or
-package must be locked and physically secured to prevent tampering or
! removal of licensed material from storage by unauthorized personnel. The t licensee shall store licensed material in a manner which will minimize danger from explosion or fire. (2) The licensee shall lock and physically secure the transport pack-age containing licensed material to the transporting vehicle to prevent l 40 Enclosure 1 l
[7590-01] accidental loss, tampering, or unauthorized removal of the licensed mate- { rial from the vehicle. (c) Transportation precautions. The licensee shall comply with the applicable provisions of the transportation regulations prescribed in Part 71 of this chapter. (Trans-portation of radioactive materials are also subject to the Department of Transportation's regulations in 49 CFR Parts 171 through 178 which include-provisions for proper packaging, marking and labeling, placarding of the transport vehicle, monitoring, accident reporting and.for shipping papers.) S 39.33 Radiation detection instruments. (a) The licensee shall keep a calibrated and operable radiation survey instrument at each field station and temporary jobsite to make the radiation surveys that are required by this part and by Part 20 of this chapter. To satisfy this requirement, the radiation survey-instru-ment must be capable of measuring 0.1 milliroentgen per hour through at
.least 100 milliroentgens per hour. Survey instruments acquired before
[one year after the effective date] and capable of measuring 0.1 milli-i roentgen per hour through at least 20 milliroentgens per hour also satisfy this requirement until [5 years after the effective date]. l (b) The licensee shall have available additional calibrated and operable radiation detection instruments capable of detecting radiation and contamination levels that could be encountered during well-logging o operations or in the event of an accident. The licensee may own the l i instruments or may arrange to obtain them from a second party. (c) The licensee shall have each radiation survey instrument required under (a) of this section calibrated-- 41 Enclosure 1 l-
. _ . . .c . . .. a. . . . - ----.~.ie----*e*--"'"'~"-*-'""*
[75?0-01] 1 (1) At intervals not to exceed 6 months and after instrument servicing; (2) At two points located approxinately 1/3 and 2/3 of full scale on each scale (for logarithmic scale, at mid range of each decade, and at two points of at least one decade); and (3) So that accuracy within plus or minus 20 percent of the true radiation level can be demonstrated on each scale. (d) The licensee shall maintain calibration records for a period of 3 years after the date of calibration for inspection by the Commission. S 39.35 Leak testing of sealed sources. (a) Testing and recordkeeping requirements. Each licensee using a sealed source shall have the source tested for leakage. The licensee shall keep a record of the leak test result in units of microcuries and maintain the record for inspection by the Commission for 3 years after the leak test is performed. i (b) Method of testing. A test for leakage must be performed only by a person specifically authorized by the Commission or an Agreement State to perform the test. The test sample must be taken from the nearest accessible point to the sealed source where contamination might accumulate. The test sample must be analyzed for radioactive contamina-tion. The analysis must be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. (c) Test frequency. Each sealed source must be tested for leakage at intervals not to exceed 6 months. In the absence of a certificate 42 Enclosure 1
[7590-01] from a transferor that a test has been made within the 6 months before the transfer, the sealed source may not be used until tested. (d) Removal of leaking source from service (1) If the test conducted pursuant to paragraphs (a) and (b) of this.section reveals the presence of 0.005 microcurie or more of removable radioactive material, the licensee shall remove the sealed source from service immediately and have it decontaminated, repaired, or disposed of by an NRC or Agreement State licensee that is authorized to perform these functions. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by an authorized licensee. (2) The licensee shall file a report with the appropriate NRC Regional Office listed in Appendix 0 of Part 20 of this chapter, within 5 days of the test. The report must describe the equipment involved-in the leakage, the test results, any contamination which resulted from the leaking source, and the corrective action taken. (e) Exemptions from testing requirements. The following sealed sources are exempt from the periodic leak test requirements in para-graphs (a) through (d) of this section: (1) Hydrogen-3 sources; (2) Sources containing licensed material with a half-life of 30 days or less; (3) Sealed sources containing licensed material in gaseous form; (4) Sources of beta- and/or gamma-emitting radioactive material with an activity of 100 microcuries or less; and (5) Sources of alpha-emitting radioactive material with an activ-ity of 10 microcuries or less. 43 Enclosure 1
[7590-01] 1 S 39.37 Physical inventory. Ear'1 licensee shall conduct a semiannual physical inventory to account for all licensed material received and possessed under the license. The licensee shall maintain records of the inventory for 3 years from the date of the inventory for inspection by the Commission. The inventory must indicate the quantity and kind of licensed material, location of the licensed material, the date of the inventory, and the name of the individ-ual conducting the inventory. 4 6 39.39 Utilization records. (a) Each licensee shall maintain a record showing the following information for each utilization of licensed material: (1) The make, model number, and a serial number or a description of each sealed source used; (2) In the case of a radioactive marker or unsealed licensed mate-rial used for subsurface tracer studies, the radionuclide and quantity of activity used in a particular well; (3) The identity of the logging supervisor and logging assistants to whom the licensed material is assigned; and (4) Location and date of use of the licensed material. (b) The licenseo shall maintain the records required by paragraph (a)
-available for inspection by the Commission and shall retain the record for 3 years from the date of the recorded event.
S 39.41 Design and performance criteria for sealed sources. (a) A licensee may not use a sealed source, except one containing licensed material in gaseous form, manufactured after [one 44 Enclosure 1
[7590-01] year after the effective date of the final rule] in well-logging unless the manufacturer certifies to the licensee that the sealed source meets the following criteria: (1) It is of doubly encapsulated construction; (2) It contains licensed material whose chemical and physical forms are as insoluble and non-dispersible as practical; (3) It has individually passed pressure testing to 24,600 pounds per square inch absolute without leakage; and (4) It meets the following performance requirements by prototype test-ing. Compliance with the tests is determined by the ability of the pro-totype to maintain its integrity after each of the following tests: (i) Temperature test - the test source must be held at -40*C for 20 minutes,- 600*C for 1 hour, and then be subject to a thermal shock test with a temperature drop from 600 C to 20 C within 15 seconds; (ii) Impact test - a 5 kg steel hammer, 2.5 cm in diameter, must be dropped from a height of 1 m onto the test source; (iii) Vibration test - the test source must be subject to a vibra-tion from 25 Hz to 500 Hz at 5 g amplitude for 30 minutes; and (iv) Puncture test - a 1 gram hammer and pin, 0.3 cm pin diameter, must be dropped from a height of 1 m onto the test source. (b) After [2 years after the effective date of this rule], a licensee may not use a sealed source manufactured before [one year after the effec-tive data of this rule], except one containing licensed material in gaseous form, unless the manufacturer, or a qualified testing organization, cert-ifies to the licensee that the sealed source meets: (1) The criteria of paragraphs (a)(1), (a)(2), and (a)(3) of this section; or 45 Enclosure 1
[7590-01] (2) The criteria of paragraphs (a)(1), (a)(2), (a)(3) of this section by prototype test, and the performance requirement of paragraph (a)(4) of this section. (c) The licensee shall keep the certification documents described by paragraphs (a) and (b) of this section for inspection by the Commission for 3 years after transfer or disposal of the source or its abandonment in a well. 6 39.43 Inspection, maintenance, and opening of a source or source holder. 4 (a) Each licensee shall inspect the source holders, logging tools, and source handling tools for obvious defects before the equipment is used each day to ensure that the equipment is in good working condition. (b) Each licensee shall conduct a program of visual inspection and maintenance of source holders, logging tools, source handling tools, stor-age containers, transport containers, injection tools, and sinker bars to ensure that the required labeling is legible and that visual physical damage is absent. The licensee shall perform the visual inspection and maintenance at least every 6 months. The licensee shall maintain records of inspection and maintenance for 3 years for inspection by the Commission. (c) If the inspection conducted under paragraph (a) of this section reveals damage to the labeling or to components critical for radiation safety, the licensee shall remove the item from service until repairs are made. (d) Removal of a sealed source from a source holder, and maintenance on sealed sources, holders or pressure housings in which sealed sources are placed, or on other equipment containing a sealed source may not be 46 Enclosure 1
[7590-01] performed unless a written instruction has been approved by the Commission as part of the license application. (e) If a sealed source is stuck in the source holder or logging tool, the licensee may not perform any operation, such as drilling, cutt-ing, or chiseling, on the source holder or logging tool, unless it is specifically licensed by the Commission to perform this operation. (f) The repair, opening, or modification of any sealed source must be performed only by persons specifically licensed to do so by the Commission. S 39.45 Subsurface tracer studies. (a) The licensee shall require all personnel handling radioactive tracer material to use protective gloves and clothing and other appro-priate equipment. The licensee shall take precautions to avoid ingestion or inhalation of radioactive tracer material and to avoid contamination of field stations and temporary jobsites. (Bioassay services may be required by S39.65(b).) (b) A licensee may not inject licensed material into fresh water aquifers unless specifically authorized to do so by the Commission. S 39.47 Radioactive markers. The licensee may not use a radioactive marker in wells, unless the individual marker contains quantities of licensed material not exceeding the specified quantities in S 30.71 of this chapter. 47 Enclosure 1
~
[7590-01] S 39.49 Uranium sinker bars. The licensee may not use a uranium sinker bar in well-logging opera-tions after [one year from the effective date of the rule], unless it is legibly impressed with the words " CAUTION-RADI0 ACTIVE-URANIUM" and " NOTIFY CIVIL AUTHORITIES OR (COMPANY NAME) IF FOUND." S 39.51 Use of a sealed source in a well without surface casing. The licensee may not use a sealed source in a well without a surface casing designed to protect fresh water aquifer zones, unless procedures for protecting these zones are specifically approved by the Commission. SUBPART D - RADIATION SAFETY REQUIREMENTS S 39.61 Training. 1 (a) The licensee may not permit an individual to act as a logging supervisor until that person: (1) Has completed at least 40 hours of formal training in the
- subjects outlined in paragraph (e) of this section; (2) Has received copies of and instruction in
(i) NRC regulations contained in this part and in the applicable sections of Parts 19, 20, 21, 30, 40, 70, and 71 of this chapter; (ii) The NRC license under which the logging supervisor will < perform well-logging operations; and (iii) The licensee's operating, recordkeeping, and emergency procedures; 48 Enclosure 1
[7590-01] (3) Has completed 3 months of on-the-job training and demonstrated competence in the use of licensed materials, remote handling tools, and radiation survey instruments by a field evaluation; and (4) Has demonstrated understanding of the requirements in sub-paragraphs (a)(1) and (a)(2) by successfully completing a written test. (b) The licensee may not permit an individual to act as a logging assistant until that person: (1) Has received instruction in applicable sections of Parts 19, 20, and 21 of this eiapter; (2) Has received copies of and instruction in the licensee's operat-ing and emergency procedures; I (3) Has demonstrated understanding of the materials listed in paragraphs (b)(1) and (2) of this section by successfully completing a written or oral test; and , (4) Has received instruction in the use, under the personal supervi-sion of the logging supervisor, of tracer material, sealed sources, remote handling tools, and radiation survey instruments. (c) The licensee shall provide for the annual retraining of logging supervisors and logging assistants. (d) The licensee shall maintain a record of each logging supervisor's and logging assistant's training, including copies of written tests and dates of oral tests, for 3 years following the termination of employment. (e) The licensee shall include the following subjects in the formal training required in paragraph (a)(1) of this section: (1) Fundamentals of radiation safety: (i) Characteristics of radiation; (ii) Units of radiation dose and quantity of radioactivity; (iii) Hazards of exposure to radiation; 49 Enclosure 1
O t [7590-01]- (iv) Levels of radiation from licensed material; (v) Methods of controlling radiation dose: (A) Working time; (B) Working distances; (C) Shielding; , (vi) Radiation safety practices, including prevention of contamination, J and methods of decontamination;
- (2) Radiation detection instrumentation to be used
(i) Use of radiation survey instruments: (A) Operation; l (B) Calibration; (C) Limitations; (ii) Survey techniques;
- (iii) Use-of personnel monitoring equipment; (3) Equipment to be used
(i) Handling equipment and remote handling tools; (ii) Licensed materials; (iii) Storage, control, and disposal of equipment and licensed I materials; i (iv) Operation and control of equipment and licensed materials; (v) Maintenance of equipment; - (4) The requirements of pertinent Federal and State regulations; and j (5) Case histories and potential consequences of accidents in well-logging operations. i 1 ~ 50 Enclosure 1
[7590-01] !
$ 39.63 Operating and emergency procedures.
Each licensee shall develop and follow written operating and emer-gency procedures that cover instruction in-- (a) The handling and use of licensed materials to be employed so that no individual is likely to be exposed to radiation doses in excess of the limits established in Part 20 of this chapter; (b) Methods and occasions for conducting radiation surveys; (c) Methods and ot.casions for locking and securing licensed materials; (d) Personnel monitoring and the use of personnel monitoring equipment; (e) Transportation of licensed materials to field stations or tempo-rary jobsites, including packing of licensed materials in vehicles, placarding of vehicles when needed, and physically securing licensed materials to transport vehicles during transportation to prevent accidental loss, tampering, or unauthorized removal; (f) Minimizing personnel exposure, including that from inhalation and ingestion of licensed materials, during well-logging operations and in the event of an accident; (g) The procedure for notifying proper persons in the event of an accident; (h) Maintenance of records; (i) The inspection and maintenance of source holders, logging tools, source handling tools, storage containers, transport containers, and injection tools; (j) The procedure to be followed if a sealed source is lodged in a well or ruptured; 51 Enclosure 1 i
[7590-01] (k) The procedure to be used for picking up, receiving, and opening packages containing licensed materials; (1) The procedure for identifying and reporting to NRC defects and noncompliance, as required by Part 21 of this chapter; (m) The procedure and the use of tools for remote handling of sealed sources and radioactive tracer material, except low-activity calibration sources; (n) The procedure to be used for detecting contamination, required by S 39.67(c) through (e), and for preventing the spread of contamina-tion; and (o) The procedure to be used to decontaminate the environment, equipment or personnel if any or all are contaminated. S 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging supervisor or logging assistant unless that person wears, at all times during well-logging operations, either a film badge or a thermoluminescent dosimeter (TLD). Each film badge or TLD must be assigned to and worn by only one individual. The film badge must be replaced at least monthly and TLD badges replaced at least quarterly. The licensee shall have each badge or dosimeter processed. (b) The licensee shall provide appropriate bioassay services to individuals using licensed materials in subsurface tracer studies. (c) The licensee shall keep reports received from the badge or TLD processor and from the bioassay service laboratory for inspection until the Commission terminates the license. 52 Enclosure 1
[7590-01] S 39.67 Radiation surveys. (a) The licensee shall make radiation surveys, including but not limited to paragraphs (b) through (e) of this section, of each area where licensed materials are used and stored. (b) Before transporting the licensed materi is, the licensee shall make a radiation survey of the position occupied by each individual in the vehicle and of the exterior of each vehicle used to transport the licensed materials. (c) After removing the sealed source assembly from the logging tool and before departing from the temporary jobsite, the licensee shall confirm that the logging tool is free of contamination by energizing the logging tool detector or by using a survey meter. (d) If the licensee suspects that, as a result of operations involving a sealed source, the encapsulation of the sealed source could be damaged by the operation, it shall conduct a radiation survey, includ-ing a contamination survey, during and after the operation. (e) The licensee shall make a radiation survey at the temporary jobsite for each subsurface tracer study. The survey must include a measurement of radiation levels before and after the operation, and a measurement of contamination levels after the subsurface tracer study. (f) The results of surveys required under paragraphs (a) through (e) of this section must be recorded and must include the date the survey took place, the name of the individual making the survey, the identifica-tion of the survey instrument used, and the location of the survey. The licensee shall maintain records of surveys for inspection by the Commis-sion for 3 years after they are made. 53 Enclosure 1
y L4 l s [7590-01]
$ 39.69 Radioactive contamination control.
1 (a) During efforts to recover a sealed source lodged in the well, the l 1 licensee shall continuously monitor, with an appropriate radiation detec- i tion instrument or a logging tool with a radiation detector, the circulat-ing fluids from the well to check for contamination resulting from damage to the sealed source. (b) If the licensee detects evidence that the sealed source has ruptured or licensed materials have caused contamination, it shall initiate the emergency procedures required by S 39.63 immediately. (c) If contamination results from the use of licensed material in well-logging operations, the licensee shall decontaminate all work areas, equipment, and unrestricted areas. SUBPART E - SECURITY, RECORDS, NOTIFICATIONS S 39.71 Security. During each well-logging operation, the logging supervisor or other licensee employee designated by the logging supervisor shall maintain direct surveillance of the operation to prevent unauthorized entry into a restricted area, as defined in S 20.3(a)(14) of this chapter. S 39.73 Documents and records required at field stations. (a) Each licensee shall maintain the following documents and records at the field station: (1) A copy of applicable NRC regulations; (2) The license authorizing the use of licensed material; 54 Enclosure 1
1 . [7590-01] (3) Operating and emergency procedures; (4) The record of the radiation survey instrument calibration required by S 39.33; (5) The record of the leak test results required by 9 39.35; (6) Physical inventory records required by S 39.37; (7) Utilization records required by 9 39.39; (8) Records of inspection and maintenance required by S 39.43; (9) Training records required by 6 39.61(d); and (10) Survey records required by S 36.67. (b) Records required by paragraphs (a) (1)-(3) of this section must be kept until the licensee terminates its well-logging operations ! at the field station. Records required by paragraphs (a) (4)-(10) of this section must be kept for 3 years. S 39.75 Documents and records required at temporary jobsites. Each licensee conducting operations at a temporary jobsite shall maintain the following documents and records at the temporary jobsite until the well-logging operation is completed: (a) Operating and emergency procedures; (b) Evidence of latest calibration of the radiation survey instru-ments in use at the site required by S 39.33; (c) Latest survey records required by S 39.67; (d) The shipping papers for the transportation of radioactive mate-rials required by S 71.5 of this chapter; and 55 Enclosure 1
[7590-01] (e) A copy of the NRC license authorizing use of licensed materials, or a copy of the Agreement State license when operating under reciprocity pursuant to 9 150.20 of this chapter. S 39.77 Notification of incidents and lost sources; abandonment procedures for irretrievable sources. (a) The licensee shall immediately notify the appropriate NRC Regional Office by telephone and subsequently within 5 days by confirma-tory letter if it knows or has reason to believe that (1) licensed mate-rial has been lost in or near a fresh water aquifer; or (2) a sealed source has been ruptured. This notice must designate the well or other location and describe the magnitude and extent of loss of licensed mate-rials, assess the consequences of the loss or rupture, and explain efforts planned or being taken to mitigate these consequences. (b) The licensee shall notify the Commission of incidents and sources lost, other than in the well, in accordance with SS 20.402, 20.403, and 20.405 of this chapter. (c) If a sealed source becomes lodged in a well, and when it becomes apparent that efforts M ( tcover the sealed source will not be successful, the licensee dri'- (1) Advise the well owner se operator, as appropriate, of the abandonment procedures under S 39.15(b) or (c) and ensure that these procedures are implemented within 30 days after the sealed source has l been classified as irretrievable; and (2) Notify the appropriate NRC Regional Office by telephone of the circumstances of the loss, and request approval to implement abandonment procedures. 56 Enclosure 1
[7590-01] (d) The licensee shall, within 30 days after a sealed source has been classified as irretrievable, make a report in writing to the appro-priate NRC Regional Office. The licensee shall send a copy of the report to each appropriate State agency that has authority over the particular well-drilling operation. The report must contain the following information: (1) Date of occurrence; (2) A description of the irretrievable well-logging source involved, including radionuclide, quantity, chemical and physical form; (3) Surface location and identification of the well; (4) Results of efforts to immobilize and seal the source in place; (5) Depth of the source; (6) Depth of the top of the cement plug; (7) Depth of the well; (8) Any other information (e.g., warning statement) contained on the permanent identification plaque; (9) Notifications made to State agencies; and (10) A brief description of the attempted recovery effort. SUBPART F - EXEMPTIONS S 39.91 Applications for exemptions. The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulation in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. 57 Enclosure 1 n
[7590-01] SUBPART G - ENFORCEMENT S 39.101 Violations. (a) An injunction or other court order may be obtained to prohibit a violation of any provision of this part. (b) A court order may be obtained for the payment of a civil penalty imposed for violation of this part. (c) Any person who willfully violates any provision of this part issued under section 161b., i., or o. of the Atomic Energy Act of 1954, as amended, or the provisions cited in the authority citation at the beginning of this part may be guilty of a crime and, upon conviction, may be punished by fine or imprisonment, or both, as provided by law. PART 19 - NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS; INSPECTIONS 1 S 19.2 [ Amended]
- 2. Section 19.2 is amended by adding "39," after " Parts 30 through 35," in the first sentence.
S IS.3 [ Amended]
- 3. Section 19.3(d) is amended by adding "39," after " Parts 30 through 35," in the first sentence.
58 Enclosure 1
[7590-01] PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION S 20.2 [ Amended]
- 4. Section 20.2 is amended by adding "39," after " Parts 30 through 35," in the first sentence.
S 20.3 [ Amended]
- 5. Section 20.3(a)(9) is amended by adding "39," after " Parts 30 through 35," in the first sentence.
PART 21 - REPORTING 0F DEFECTS AND NONCOMPLIANCE 6 21.2 [ Amended]
- 6. Section 21.2 is amended by adding "39," after "34, 35," in the first sentence.
PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL S 30.4 [ Amended] i
- 7. In S 30.4, paragraphs (b) and (i) are amended by adding "and 39" after "31 through 35" and paragraph (x) is removed.
59 Enclosure 1
~ . l
[7590-01] 9 30.5 [ Amended]
- 8. Section 30.5 is amended by adding "and 39" after "31 through 35".
S 30.6 [ Amended]
- 9. In S 30.6, paragraph (b) (1) is amended by adding "39" after "30 through 35" in the first sentence.
S 30.11 [ Amended]
- 10. In 6 30.11, paragraph (a) is amended by adding "and 39" after "31 through 35".
S 30.13 [Amanded]
- 11. Section 30.13 is amended by adding "and 39" after "31 through 35".
S 30.14 [ Amended]
- 12. In S 30.14, paragraph (a) is amended by adding "and 39" after "31 through 35" and paragraph (c) is amended by removing "and 34" and adding "34 and 35" after "32, 33". f 60 Enclosure 1
r - [7590-01] S 30.15 [ Amended]
- 13. In S 30.15, paragraph (a) is amended by adding "and 39" after "30 through 35".
S 30.18 [ Amended]
- 14. In S 30.18, paragraph (a) is amended by adding "and 39" after "30 through 34".
I S 30.31 [ Amended]
- 15. Section 30.31 is amended by adding "and 39" after "32 through 35".
S 30.33 [ Amended] ! 16. Section 30.33, paragraph (a)(4) is amended by adding "and 39" after "32 through 35". S 30.34 [ Amended] I l
- 17. Section 30.34, paragraph (a) and (b) are amended by adding "and 39" l
l after "31 through 35"; paragraph (c) is amended by adding "and 39" after "31 through 35" in the first and the second sentences; paragraphs (d) and (e) are amended by adding "and 39" after "31 through 35". l j' 61 Enclosure 1 i i v - --. _. - _ _ , . _ . - . . _ _ _ . .- - . _ _ . _ . - _-
' ~
[7590-01] S 30.39 .[ Amended]
- 18. Section 30.39 is amended by adding "and 39" after."32 through 35".
P S 30.56 [ Removed]
- 19. Section 30.56 is removed.
PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL 5 40.5 [ Amended]
- 20. In S 40.5, paragraph (b)(1) is amended by adding "39," after "30 through 35," in the first sentence.
PART 51 - ENVIRONMENTAL REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS l' l S 51.22 [ Amended] ' l i i (- 21. In S 51.22, paragraphs (c)(3), (c)(10) and (c)(14) are amended by adding "39," after "34, 35," in the first sentence of each paragraph. l 62 Enclosure 1
, , - - , - , -- ., . - - - , - - - - --,,e,, . , -
[7590-01] PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL S 70.4 [ Amended]
- 22. In S 70.4, paragraph (w) is removed.
S 70.5 [ Amended]
- 23. In S 70.5, paragraph (b) (1) is amended by adding "39" after "30 through 35."
S 70.60 [ Removed]
- 24. Section 70.60 is removed.
PART 71 - PACKAGING AND TRANSPORTATION OF RADI0 ACTIVE MATERIAL S 71.0 [ Amended]
- 25. In S 71.0, paragraph (b) is amended by adding "39," after "21, 30," in the first sentence.
63 Enclosure 1
I~ . [7590-01] PART 150 - EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274 S 150.20 [ Amended]
- 26. In S 150.20, paragraph (b) is amended by removing "70.60, to 70.62, inclusive," and adding "70.61, 70.62," after "70.51 to 70.56, inclusive,"; and by adding "$39.15 and Subparts C, D, E, F, and G of Part 39" after "and to the provisions of Parts 19, 20, and 71" of the first sentence.
(The conforming amendments to Parts 19, 20, 21, 30, 32, 40, 51, 70, 71, and 150 are issued under the following authority: Sec. 161, Pub. L. 83-703, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, Pub. L. 93-438, 82 Stat. 1242, as amended (42 U.S.C. 5841).) Dated at Bethesda, Maryland this day of , 1984. For the Nuclear Regulatory Commission. William J. Dircks, Executive Director for Operations. 64 Enclosure 1
o . The Honorable Alan Simpson, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Register. The NRC is con-sidering amending its regulations to provide specific radiation safety require-ments for the use of licensed material in well-logging operations. Current NRC regulations do not provide specific requirements but instead impose them as licensing conditions. The proposed rule would provide: (1) comprehensive and consistent regulations applicable to well-logging operations; (2) uniform requirements in NRC and Agreement State regulations, allowing well-logging licensees to operate in both Agreement States and Non-Agreement States with ease; and (3) safety require-ments designed to reduce the likelihood of accidents involving the rupture of radioactive sources in well-logging operations. Sincerely, Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
Notice of Proposed Rulemaking cc: Senator Gary Hart Enclosure 2
-4 I WEEKLY NOTES DIVISION OF RISK ANALYSIS AND OPERATIONS OFFICE OF NUCLEAR REGULATORY RESEARCH Proposed Rule signed by EDO On , 1984, the Executive Director for Operations approved a proposed rule 10 CFR Part 39. This proposed rule vould provide specific radiation safety requirements for the use of licensed material in well-logging operations. Current NRC regulations do not provide specific requirements but impose them as licensing conditions.
This notice constitutes notice to the Commission that, in accordance with the
~
rulemaking authority delegated to the EDO, the ED0 has signed this proposed rule for publication'in the Federal Register.. 4 J ll a Enclosure 3
r 2 4' DRAFT -
' ~
l' NRC CONSIDERS REGULATIONS ON WELL LOGGING OPERATIONS The Nuclear Regulatory Commission is considering amending its regulations to include specific safety requirements for the use of radioactive materials in well-logging operations. The oil and gas industry uses well-logging techniques to obtain information on the properties of underground formations--such as the type of rock, porosity, hydrocarbon content and density--in new and existing wells. One technique involves lowering a sealed radioactive source, with an associated radiation detector, into a well on a wire line. Information collected by the detector is sent to the surface through the wireline while the radioactive source and detector are slowly raised from the bottom. The log of the well is produced by recording the way in which radiation emitted from the source is reflected back from the underground formation to the detector. Americium and cesium are the radioactive materials most commonly used for this purpose. Similar use of the materials is made in coal and other mineral exploration. As of July 1984, 174 NRC licensees were authorized to use radioactive materials in well-logging operations. In addition, 27 states have reached an i agreement with the NRC under which they regulate well-logging (as well as certain other activities involving commercial use of radioactive materials). These Agreement States have about 400 well-logging licensees. Enclosure 4 .,
e DRAFT Current NRC regulations do not contain radiation safety requirements specifically related to the use of nuclear materials in well-logging operations. Instead these operations are regulated through the general safety requirements for use of nuclear materials and through conditions of each individual license imposed on a case-by-case basis. The proposed rule would provide comprehensive and consistent regulations in this area and is designed to reduce the likelihood of an accident involving radioactive material. Specific requirements of the proposed rule would include: (1) The licensee (well-logging company) would be required to enter into a written agreement with the well owner or operator in which the owner or operator commits to make a reasonable effort to recover any radioactive source that gets stuck in the well. The owner or operator would also agree not to release contaminated equipment or property surrounding the well for unrestricted use until the equipment or property has been decontaminated. This agreement is needed because the well-logging company itself might not have the legal authority or resources to recover a radioactive source that gets lost in a well. (2) Licensees would be prohibited from forcing a stuck sealed radioactive source out of its holder in a manner that could endanger the sealed source's integrity unless the action was specifically authorized by the NRC. Rupture of the sealed source could cause radioactive contamination of the facility, personnel and environment.
r b J
. DRAFT (3) Performance criteria would be established for the sealed radioactive sources. After a phase-in period, the sealed sources used by well-logging licensees would have to be doubly encapsulated, contain nuclear material that
.is relatively insoluble and nondispersible and either have individually passed a pressure test or be similar to a prototype that has passed tests complying with standards of the American National Standards Institute.
Interested persons are invited to submit written comments on the proposed rule, which would be contained in a new Part 39 of the Commission's regulations. Comments should be sent to the Secretary, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, Attention: Docketing and Services Branch, by (90 days after publication in the Federal Register on ).
r g PRELIMINARY REGULATORY ANALYSIS 10 CFR Part 39 LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL-LOGGING OPERATIONS
- 1. STATEMENT OF THE PROBLEM Existing Commission regulations do not specify detailed safety requirements governing the use of licensed material in well-logging operations. Some general requirements pertaining to well-logging operations are addressed in 10 CFR Parts 20, 30, and 70. Because about 50,000 wells are logged each year (total in both the Agreement States and non-Agreement States) in the oil, gas and mineral industry and about 5,000 workers are involved in these operations, a uniform set of radiation safety requirements in the Commission's regulations appears necessary. At present, the Commission specifies safety requirements for these operations as license conditions for 174 NRC licensees (as of July 1984).
Typical radioactive sources used in well-logging operations include sealed sources containing americium-241 (0.25 curie to 20 curies) and cesium-137 (2 to 3 curies); and millicurie quantities of short-lived tracer materials to label well fluids. A major problem with the current practice is that radiation safety requirements applicable to the industry are specified as license conditions on a case-by-case basis rather than spelled out in uniform regulations that are applicable to all licensees. This requires duplication of effort and allows for discrepancies in requirements among the specific licenses issued by NRC and the Agreement States. Problems in the consistent and uniform application of these require-ments could become a greater concern because, under the NRC's program for the 1
0 decentralization of material licensing actions, well-logging licenses are issued by the five NRC Regional Offices instead of NRC Headquarters. In response to concerns expressed by several States with extensive oil and gas activities, a task force was established by the Conference of Radiation Control Program Directors to develop a set of radiation safety requirements for use of radioactive material in well-logging operations. The task force was composed of representatives from the States, the affected industry, and federal agencies, including the NRC. In keeping with previous practices of the organization, the Conference adopted these requirements as Part W of the " Suggested State Regulations for Control of Radiation" (SSRCR). The States of Arkansas, Kentucky, Oregon, and Texas have already adopted Part W requirements as State regulations without substantive changes. Other Agreement States are also considering adopt-ing Part W requirements. Because many well-logging companies operate in both Agreement and non-Agreement States, compatible NRC requirements are needed to ensure uniformity between NRC and the Agreement State regulations. Though there are about 50,000 well-logging operations each year, the probab;1-ity of an accident is very small. Nonetheless, accidents have occurred and additional safety requirements are needed to reduce the likelihood of an accident even further. There were five incidents which occurred between August 1982 and September 1983 involving radioactive sources used in well-logging operations. Three incidents involved the rupture of sources in uncontrolled workshop environments by workers performing machining or drilling operations. Two incidents involved the rupture of sources in well holes during logging tool recovery operations. The cost associated with the cleanup of radioactive material from these incidents is estimated to be in excess of 1.5 million dollars.
- 2. OBJECTIVES This regulatory action focuses on the following objectives:
to provide a comprehensive and consistent set of regulations to ensure radiation safety; 2
7- u.
- to maintain compatibility between the NRC and the Agreement States in regulating these operations:
- to reduce the likelihood of an accident involving radioactive material.
- 3. ALTERNATIVES i
The alternatives considered were as follows: 3.1 Maintain the Status Quo This alternative was not adopted because it would not provide a comprehensive and consistent regulatory framework of safety requirements for well-logging operations. Further, licensees and the public would not have an opportunity to provide comments to the NRC's requirements or any additional amendments. Also, the alternative makes the reciprocity with Agreement States more difficult because the safety requirements could be different. 3.2 Promulgate a New Part in NRC Regulations Based on Part W This alternative was adopted because:
- it provides a sound regulatory base because Part W was adopted by four Agreement States and used successfully; it provides compatability with the Agreement States safety require-ments and thus provides a simple mechanism for reciprocity; it provides licensees with the opportunity to suggest modifications of the regulations.
- it provides a single location for safety requirements for using byproduct, source and special nuclear material in well-logging operations.
3
3.3 Amend Parts 30, 40, and 70 Based on Part W The alternative was not adopted because:
- the safety requirement would be fragmented and thus, more confusing when used by licensees or NRC licensing reviewers and inspectors; many requirements would have to be repeated in two or three Parts.
- 4. CONSEQUENCES 4.1 Costs 4.1.1 NRC Operations Anticipated costs to the NRC are expected to be low for this action. An esti-mated one-time cost of 1/2 professional staff year ($50,000) effort will be needed to support this rulemaking activity. Additional costs include the cost
~o f publication of the Federal Register Notices of Proposed and Final Rulemaking.
4.1.2 Other Government Agencies Agreement States would be asked to review the proposed rule. Each review would require a total estimated staff time of 8 hours. For the 27 Agreement States, the total one-time review effort is estimated at approximately 200 person-hours ($10,000). 4.1.3 Industry Approximately 170-180 licensees of the Commission would be affected by this proposed action. The number of licensees is not expected to vary substantively in the near future. Each licensee would be required by the regulation to imple-ment the requirements in the areas of personnel safety, working practices, operating procedures and equipment. The total cost for implementation of all requirements, if they were being implemented for the first time, would be approximately $1.3 million per year for NRC licensees or approximately $7,400 4
r . per licensee per year as shown in Table 1. However, most requirements are already applied as licensing conditions; thus, the increase in cost to the affected licensees from this action would be approximately $350,000 per year for NRC licensees or approximately $2,000 per licensee per year. 4.1.4 Public There would be no associated cost to the public from this action. 4.1.5 Total Cost The total cost of the proposed rule is comprised of the sum of NRC costs, the costs of other Government Agencies, and Industry costs. The NRC and other Government Agencies costs are one-time costs that occur at the beginning of the rulemaking cycle; therefore these costs can be added directed into the total cast. However, the Industry costs are presented in terms of cost / licensee / year or annual cost. Thus these costs must be summed over a number of years and added to the NRC and other Agency costs to obtain the total cost. The accepted way to aggregate these annual costs is to use the "present Value Discounting" method (this method is described in NUREG/CR-3568 pp.C.1 - C.5). The Present Value of this stream of annual costs equals (the number of licensees) X (cost per licensee) X (the present value discount factor). In the case, we will assume a real discount rate of 10% and a time period of 20 years, which gives a present value discount factor of 8.51. Therefore, the stream of annual Industry costs equals 180 x 2000 x 8.51 or $3 million in constant dollars for a time period of 20 years. And the total cost of this rule would be the sum of NRC costs, other agencies costs and the present value of the stream of annual Industry costs, or $100,000 + $10,000 + $3,000,000 =
$3,110,000 for 20 years.
4.2 Benefits 4.2.1 NRC Operations The benefits from this action are: 5
TABLE 1 Total Industry Cost for Implementing Part 39 Costs No. of Unit cost units (or Total Section Content (or time) Freq/yr/ unit units /yr) cost /yr Remarks 39.1 - General Provisions ---------------------No Cost------------------------ 1. Administrative procedure. 39.11 2. Assumes 2,000 workers operate under NRC licenses. 39.13 Specific License - I hr/Insp. 1/yr 2000 persons $60,000 Assumes $30/hr. Internal Inspec-tion. 39.15 Written Agreement ---------------------No Cost------------------------ Currently required in Parts 30 and 70. cn 39.31 Labels, etc ---------------------No Cost------------------------ Currently required in Parts 20 and 71. 39.33 Detection Instruments - $500/ event -- 20 events /yr $10,000 1. Survey instruments are High Sensitivity currently required by Instruments Part 20.
- 2. Assumes 20 events per year that require consultant with high sensitivity instrumentation (unit cost includes transportation of the consultant).
39.35 Leak Test $40/ 2/yr 1800 sources $144,000 1. Currently required as leak test license condition.
- 2. Assumes 180 NRC licensees with an average of 10 sources per licensee.
TABLE 1 (Continued) Costs No. of Unit cost units (or Total Section Content (or time) Freq/yr/ unit units /yr) cost /yr Remarks 39.37 Physical Inventory 6 min / 2/yr 1800 sources $11,000 1. Currently required as source license condition.
- 2. Assumes $30/hr.
39.39 Utilization Record 3 min / -- 20,000 uses/yr $30,000 1. Currently required as use license condition.
- 2. Assumes 20,000 well-logging operations were performed by NRC licensees ($30/hr).
39.41 Sealed Source $300/ 0.1 1800 sources $54,000 1. Most sources manufactured 'd Performance source (10 yr life) after 1968 comply with
- New Source the requirement.
- 2. Assumes 10 years life for each source.
- Old Source $500/ source 0.3 (replace 20 sources $3,000 1. Assumes 20 cesium sources, in 3 years) which can not meet the requirements, must be replaced.
39.43 Inspection and 1. Currently required as Maintenance license condition.
- Daily 10 min / day -- 10,000 days /yr $50,000 2. Assumes $30/hr.
- Semi Annually 30 min / 2/yr 1800 sources $54,000 source 39.45 Tracer Studies - $10/ study --
5,000 $50,000 1. Currently required as glove, clothing studies /yr license condition.
- 2. Assumes 25% of the 20,000 well-logging operations involving tracer studies.
TABLE 1 (Continued) Costs No. of Unit cost units (or Total Section Content (or time) Freq/yr/ unit units /yr) cost /yr Remarks 39.49 Sinker Bars $10/ sinker 0.2/yr 100 $200 Assume 10% of NRC licensees bars (5 yr life) sinker bars and 6 sinker bars / licensee. 39.51 Wells without $20/ event -- 200 events /yr $4,000 1. Assumes 1% of 20,000 well Surface Casing logged are uncased. 39.61 Training $1,000/ 0.25/yr 2,000 $500,000 1. Currently required by
- formal training person (4 yr period) persons Parts 19.12 and 30.33(a)(3) and as licensing condition.
- annual $100/ 1/yr 2,000 $200,000 2. Assumes 2,000 workers retraining person persons operate under NRC licenses.
39.63 Operating and 100 hr/ 0.1/yr 180 $108,000 1. Currently required as Emergency licensee (10 yr life) licensees license conditions. Procedures 2. Assumes $60/hr for developing procedures. 39.65 - Monitoring and ---------------------No Cost------------------------ Currently required by 39.67 Survey Part 20. 39.69 Contamination 10 hr/ -- 100 events /yr $30,000 1. Assumes 100 events of Control (continous event source recovery. monitoring) 2. Assumes $30/hr. 39.71 Security ---------------------No Cost------------------------ Currently required by Part 20.
-_- ~
1 TABLE 1 (Continued) Costs No. of Unit cost units (or Total Section Content (or time) Freq/yr/ unit units /yr) cost /yr Remarks 39.73 - Documents $100/ -- 180 $18,000 Currently required as 39.75 licensee licensees license condition. 39.77 Notification, ---------------------No Cost------------------------ Currently required by Abandonment Parts 20, 30, and 70. 39.91 Exemptions - - - - - - - - - -- - - - - - - - - -- N o C o s t- - - - - - - - - - - - - - - - -- - - - -- - Administrative procedure. Total cost $1,326,000 Already required $ 975,000 Net cost for implementing the rule $ 351,000 e Total cost / licensee = $1,326,000 = $7,400 180 Net cost / licensee = $351,000 = $2,000 180
r o providing a comprehensive and consistent set of regulations to assure radiation safety; maintaining compatibility between the NRC and the Agreement States in regulating these operations; encouraging the Agreement States to adopt similar regulations; providing a consistent regulatory program for all 5 NRC Regional Offices in administrative licensing and enforcement programs. 4.2.2 Other Government Agencies Publication of the proposed and final rules would be cost reimbursable to the Government Printing Office by the NRC. Agreement States would be able to, with a minimum effort, allow NRC licensees to conduct well-logging operations in their jurisdictions since the Federal and State Regulations would be compatible. 4.2.3 Industry The benefits to the industry are: having a comprehensive set of requirements in the regulations with the opportunity to suggest modifications; minimizing the effort required to obtain reciprocity for NRC licensees to operate in Agreement State or vice versa. minimizing the likelihood of an accident involving radioactive material. 10
r ., 4.2.4 Public The public would benefit from a comprehensive and consistent program that would assure radiation safety. 4.3 Impacts on Other Requirements The existive regulations on the irretrievable well-logging sources (10 CFR 30.56 and 70.60) would be removed. These requirements would be consolidated in this rulemaking. 4.4 Constraints There are no constraints on this proposed rulemaking.
- 5. DECISION RATIONAL An assessment of the costs and benefits of the proposed rule leads to the con-clusion that there will be a positive impact from the uniformity of safety requirements for well-logging operations. Costs associated with this action would be negligible. Therefore, the proposed action is recommended.
- 6. IMPLEMENTATION No implementation pr,oblems are expected. The proposed regulations are similar to the Part W of the Suggested State Regulations which has been developed by representatives from industry, States and Federal agencies, including NRC.
Public comments during the proposed rulemaking are expected to be supportive of the intent of these proposed rules. 11
n .-- o ENVIRONMENTAL ASSESSMENT FOR PROPOSED REGULATION ON WELL-LOGGING OPERATIONS Identification of the Proposed Action The Nuclear Regulatory Commission is proposing a regulation that would specify radiation safety requirements for the use of licensed material in well-logging operations. The proposed regulation would provide: (1) ccmprehensive and consistent regulations applicable to well-logging operations by consolidating essential radiation safety requirements in a new Part 39, (2) uniform safety requirements in NRC and Agreement States regulations, and (3) safety require-ments designed to reduce the likelihood of accidents involving the rupture of - radioactive sources in well-logging operations. The Need for the Proposed Action The proposed action is needed because the existing Commission regulations do not specify detailed safety requirements governing the use of licensed material in well-logging operations. Currently about 50,000 wells are logged each year in both the Agreement States and non-Agreement States in the oil, gas and mineral industry. About 5,000 workers are involved in these operations. A uniform set of radiation safety requirements in the Commission's regulations appears necessary to reduce the occupational exposure and the potential for accidents involving radiological hazard. At present, the Comission specifies safety requirements for these operations as license conditions for the 174 NRC licensees (as of July 1984).
2 A major problem with the current practice is that radiation safety requirements applicable to the industry are specified as license conditions on a case-by-case basis rather than spelled out in uniform regulations that are applicable to all licensees. This situation leads to the duplication of effort by the licensing agency and allows for discrepancies in requirements among the specific licenses issued by NRC and the Agreement States. Problems in the consistent and uniform application of these requirements could become a greater concern because, under the NRC's program for the decentralization of material licensing actions, well-logging licenses are issued by the five NRC regional offices instead of NRC headquarters. In response to concerns expressed by several states with extensive oil and gas activities, a task force was established by the Conference of Radiation Control Program Directors to develop a set of radiation safety requirements for use of radioactive material in well-logging operations. The task force was composed of representatives from the states, the affected industry, and federal agencies, including the NRC. In keeping with previous practices of the organization, the Conference adopted these requirements as Part W of the
" Suggested State Regulations for Control of Radiation" (SSRCR). The States of Arkansas, Kentucky, Oregon, and Texas have already adopted Part W requirements as state regulations without substantive changes. Other Agreement States are also considering adopting Part W requirements. Because many well-logging companies operate in both Agreement and non-Agreement States, compatible NRC requirements are needed to ensure uniformity between NRC and the Agreement State regulations.
r o 3 s Though there are about 50,000 well-logging operations each year, the probabil-ity of an accident is very small. Nonetheless, accidents have occurred and additional safety requirements are needed to reduce even further the likelihood of an accident. There were five incidents which occurred between August 1982 and September 1983 involving radioactive sources used in well-logging operations. Three incidents involved the rupture of sources in uncontrolled workshop environments by workers performing machining or drilling operations. Two incidents involved the rupture of sources in well holes during logging tool recovery operations. The cost associated with the cleanup of radioactive material from these incidents is estimated to be in excess of 1.5 million 3 dollars. - Alternative Use of Resources In connection with the proposed action, the NRC has considered three alterna-tives: maintain the status quo; amend Parts 30, 40, and 70 based on Part W requirement; or promulgate a new part also based on Part W requirements, but dedicated to the well-logging operations. The third alternative is proposed because: o It provides a scund regulatory base. Part W has been adopted by four Agreement States and used successfully. o It provides compatibility bith the Agreement States' safety requirements and thus provides a simple mechanism for reciprocity, o
r o O 4 o It provides licensees with the opportunity to suggest modifications of the regulations. o It provides a single location for safety requirements for using by-product, source and special nuclear material in well-logging operations. o In the long run, it involves the least costly and most efficient way of using NRC's and licensee's resources. Public resources will not be impacted significantly. Environmental Impacts of the Proposed Action The proposed action would not significantly affect the quality of the human environment. The proposed action is designed to control the use of licensed materials in well-logging operations and, therefore, would not have a direct impact on the environment. However, the proposed action would reduce the occupational radiation exposures received by workers and would also reduce the chance and consequences of accidents involving the spread of radioactive contamination in the environment. Furthermore, most of the proposed require-ments are already being complied with by licensees because they are imposed by licensing conditions. Therefore, the proposed action would have no measurable negative environmental impact.
r u o' 5 Agencies and Persons Consulted The proposed action has been reviewed by the NRC staff and has been forwarded to 27 Agreement States for review. A proposed rule will be published and public coments will be requested. Findings of No Significant Impact The Comission has determined not to prepare an environmental impact statement for the proposed action because it would not have a significant effect on the quality of the human environment; the impact will be a beneficial, not a deleterious, one.
."D 06 '.3,'i HEMORN4Dutt FOR: R. Cunningham, Director Division of Fuel Cycle and Material Safety,fatSS FROM: R. Bernero, Director Division of Risk Analysis and Operations, RES
SUBJECT:
DRAFT REC 0biMENDATIONS TO EDO C0iiCERNING 13l ETHER NiD~HOW TOCONTIliUEWITHONG0IliGRULEMAKING(10CFR39) SPONSORED BY RES Enclosed for your consideration are draft reconnendations supported by a draft office review concerning whether and how to continue with an ongoing rulemaking sponsored by RES for which your, office is identified as the user office. This memorandum constitutes my concurrence in the enclosed draft recomendations. I plan to dispatch this memorandu:a with the enclosed draft recomendations to the Director, RES, two weeks from the above date. Please acknowledge receipt by returning this me.norandum with or without coments on the draft :recomendations as indicated below. hn31 signed by Malcolm L Emit Robert M. Bernero, Director Division of Risk Analysis and Operations Office of Huclear Regulatory Research
Enclosures:
- 1. Regulatory Agenda Entry (Well-logging)
- 2. Supporting Statements
- 3. Draft Proposed Rule 4.- Draft Regulatory Analysis Distribution (w/ encl.)
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\ ,,,,, OCT 2 9 384 ybi MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING Based on our review of the ongoing RES sponsored rplemaking " Periodic and Systematic Reevaluation of Parts 30 and 32," RES recommends that the NRC not continue with this specific rulemaking. This recommendation in draft form has been coordinated with the Office of Nuclear Material Safety and Safeguards. ' The basis for our recommendation is as follows: From the time of publication of the criteria for the periodic and systematic review of regulations (10 CFR Chapter I) on January 23, 1981, through the present time, various NRC offices, including RES, NMSS, ELD, and ADM, have amended or proposed to amend essentially all of the sections of 10 CFR Parts 30 and 32 involved in the comprehensive review of those regulations. RES staff has evaluated the final and ongoing proposed amendments against the criteria for periodic and systematic review and has concluded that the NRC has met its comprehensive review objective without the need for a separate periodic and systematic, review of 10 CFR Parts 30 and 32. Accordingly, there is no longer a need to continue this specific ongoing rulemaking proceeding. The staff will continue, however, in the mode of amending 10 CFR Parts 30 and 32 as the need arises for other purposes. The complete RES review package has been sent to OED0 (Attention: DEDROGR)and to the Director, NMSS. l g M i Rober . Minogue, Director Office of Nuclear Regulatory Research
* ** * % UNITED STATES
. *, NUCLEAR REGULATORY COMMisslON f; M j W ASHINGTON, D. C. 20555
..... OCT 2 S 1984 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW 0F ONG0ING RES SPONSORED RULEMAKING Based on our review of the ongoing RES sponsored rulemaking " Periodic and Systematic Reevaluation of Parts 30 and 32," RES recomends that the NRC not continue with this specific rulemaking. This recommendation in draft form has been coordinated with the Office of Nuclear Material Safety and Safeguards. The basis for our recomendation is as follows: From the time of publication of the criteria for the periodic and cystematic review of regulations (10 CFR Chapter I) on January 23, 1981, through the present time, various NRC offices, including RES, NMSS, ELD, and ADM, have amended or proposed to amend essentially all of the sections of 10 CFR Parts 30 and 32 involved in the comprehensive review of those regulations. RES staff has evaluated the final and ongoing proposed amendments against the criteria for periodic and systematic review and has concluded that the NRC has met its comprehensive review objective without the need for a separate periodic and systematic. review of 10 CFR Parts 30 and 32. Accordingly, there is no longer a need to continue this specific ongoing rulemaking proceeding. The staff will continue, hcwever, in the made of amending 10 CFR Parts 30 and 32 as the need arises for other purposes. l The complete RES review package has been sent to OEDO (Attention: DEDR0GR) and i to the Director, NMSS. i s . g W Rober . Minogue, Director Office of Nuclear Regulatory Research l l i l l l
4 s RES RULEMAKING REVIEW PACKAGE
RES IfiDEPEliDE!G LillEW BOARD VOTING SF:EE1 10: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: TITLE OF RULEftAKING: " Periodic and Systematic Reevaluation of Parts 30 and 32" AGREE WITH RECOMMENDATIONS IN RES RULEMAKING REVIEW PACKAGE MODIFY RECOMMENDATIONS IN NOT PARTICIPATING
- RES RULEMAKING REVIEW PACKAGE AS INDICATED BELOW COMMENTS AND SUGGESTIONS:
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D\ RES If4DEPEfiDEr.1 Fit 1EW BOARD V0 TING SHEE1 T0: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: K. R. Goller TITLE OF RULEMAKING: " Periodic and Systematic Reevaluation of Parts 30 and 32" AGREE WITH RECOMMENDATIONS IN RES RULEMAKING REVIEW PACKAGE MODIFY RECOMMENDATIONS IN NOT PARTICIPATING. RES RULEMAKING REVIEW PACKAGE AS INDICATED BELOW COMMENTS AND SUGGESTIONS: l t b s MEMBER, RIRB \
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P.ES IriDEPEf4DEf3 f.itIEW B0ARD V0 TING SEEET 10: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: O . E . Bess eTT, ek t- 6 te. PInc TITLE OF RULEMAKING: " Periodic and Systematic Reevaluation of Parts 30 and 32" REQUEST RIRB AGREE WITH RECOMMENDATIONS MEETING. IN RES RULEMAKING REVIEW PACKAGE MODIFY RECOMMENDATIONS IN NOT PARTICIPATING
- RES RULEMAKING REVIEW PACKAGE AS INDICATED BELOW COMMENTS AND SUGGESTIONS:
l l ob5 h6((%uA4/n O. 2MEMBER,
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MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL OF NRC RULEMAKING: RES REVIEW OF ONGOING RES SPONSORED RULEMAKING Based on our review of the ongoing RES sponsored rulemaking " Periodic and Systematic Reevaluation of Parts 30 and 32." RES recomends that the NRC not continue with this specific rulemaking. This recomendation in draft fonn has been coordinated with the Office of Nuclear Material Safety and Safeguards. The basis for our recomendation is as follows: From the time of publication of the criteria for the periodic and systematic reviewofregulations(10CFRChapterI)onJanuary 23, 1981, through the present time, various NRC offices, including RES, MMSS, ELD, and ADM, have amended or proposed to amend essentially all of the sections of 10 CFR Parts 30 and 32 involved in the comprehensive review of those regulations. RES staff has evaluated the final and ongoing proposed amendments against the criteria for periodic and systematic review and has concluded that the NRC has met its comprehensive review objective without the need for a separate periodic and systematic review of 10 CFR Parts 30 and 32. Accordingly, there is no longer a need to continue this specific ongoing rulemaking proceeding. The staff will continue, however, in the mode of amending 10 CFR Parts 30 and 32 as the need l arises for other purposes. The complete RES review package has been sent to OEDO (Attention: DEDROGR) arJ to the Director, NNSS. 4 Distribution: 1 RES Central Files R-2914 j RAMRB Reading / Subject Robert B. Minogue, Director CIRC /CHRON Office of Nuclear Regulatory Research RMinogue Dross FGillespie RCunningham PPCB, RES CAG, ORM JMalaro JHenry
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- b. Updated NRC Regulatory Agenda entry.
TITLE: Periodic and Systematic Reevaluation of Parts 30 and 32 CFR CITATION 10 CFR 30; 10 CFR 32 ABSTRACT: The proposed rule would be an editorial revision of the regulations governing the domestic licensing of byproduct material and the exemptions from domestic licensing requirements. The proposed rule would reflect the application of good regulatory drafting practices. The proposed rule would simplify and clarify the format of the present regulations so that persons subject to byproduct material regulations can conveniently use and understand them. From the time of publication of the criteria for the periodic and systematic review of regulations in 10 CFR Chapter I on January 23, 1981 (46 FR 7388), through the present time, the NRC has amended or proposed to amend essentially all of the sections of 10 CFR Parts 30 and 32 involved in the comprehensive review of those regulations. NRC staff has evaluated the final and ongoing proposed amendments against the criteria for periodic and systematic review and has concluded that the NRC has met its comprehensive review objective without the need for a separate periodic and systematic review of 10 CFR parts 30 and 32. Accordingly, there is no longer a need to continue this specific ongoing rulemaking proceeding. TIMETABLE: Final Action WITHDRAWN 06/00/84 LEGAL AUTHORITY 42 USC 2111; 42 USC 2201; 42 USC 2232; 42 USC 2233; 42 USC 2234; 42 USC 5846 EFFECTS ON SMALL BUSINESS AND OTHER ENTITIES: No , AGENCY CONTACT James J. Henry Office of Nuclear Regulatory Research Washington, DC 20555 301 443-7614 3MT
=
- c. The rulemaking as currently proposed to be published in the Federal Register, i-
- Comments received on working drafts of proposed recodified 10 CFR 4 Part 30,during 1982 indicated that NRC staff members were confused as to what actually constituted a " periodic and. systematic review"
, of the whole of 10 CFR Part 30. As a consequence, the rulemaking never reached the stage of being proposed for publication in the Federal Register.
4 4 i - 1 I l-s l-l I l 1 L I
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- d. Draft recommendations to the EDO.
- 1. Whether to continue with the rulemaking.
The Director, RES, recomends that the NRC not continue with this rulemaking. The basis for this recommendation is as follows: From the time of publication of the criteria for the periodic and systematic review of regulations (10 CFR Chapter I) on January 23, 1981, through the present time, various NRC offices including RES, NMSS, ELD, and ADM have amended or proposed to amend essentially all of the sections of 10 CFR Parts 30 and 32 involved in the comprehensive review of those regulations. RES staff has evaluated the final and ongoing proposed amendments against the criteria for periodic and systematic review and has concluded that the NRC has met its comprehensive review objective without the need for a separate periodic and systematic review of 10 CFR Parts 30 and 32. Accordintjly, there is no longer a need to continue this specific ongoing rulemaking proceeding. j 2. How to proceed with the rulemaking. The Director, RES, recommends that the NRC proceed with this rulemaking as follows: (i) Update the NRC Regulatory Agenda entry for this rulemaking as enclosed in this Task Leader package, i.e., by adding to the ABSTRACT portion a statement that the NRC has met the objective of this specific ongoing rulemaking, i.e., a comprehensive
, review of its regulations (10 CFR Parts 30 and 32).
Publish the updated entry in the NRC Regulatory Agenda, Sec. I(A) as a rule on which final action has been taken. This will remove the entry from all future issues of the NRC Regulatory Agenda. i (ii) Circulate a Task Control Fonn as enclosed in this Task Leader package to the appropriate tracking system managers to remove
- Task Nos. RA 119-1 and RA 120-1 from NUREG-0566, " Standards Development Status Summary Report" (Greenbook), and Item No. 820130 from the NRC Work Item Tracking System.
Completion of these actions will allow the RES Task Leader to cease expenditure of resources on the rulemaking devoted exclusively to the
- periodic and systematic review of 10 CFR Part 30 and 32. The staff, however, will continue in the mode of amending 10 CFR Parts 30 and 32 as the need arises for other purposes.
P
- e. Results of the screening.
The staff's preliminary judgments set out below are not de novo, but rather are based largely on a document, " Notice of Compre-hensive Review of Regulations and Request for Comments," that was published in the Proposed Rules section of the Federal Register of January 23, 1981 (46 FR 7388). (See sec. f, item 1, of this Task Leader package.) The Federal Register notice references Task IV.G.2 of NUREG-0660. Task IV.G.2 is being tracked in NUREG-0933, "A Prioritization of Generic Safety Issues" as Item IV.G.2: PERIODIC AND SYSTEMATIC REEVALUATION OF EXISTING RULES. (See sec. f, item 2, of this Task Leader package.) The remaining preliminary judgments are based on the RES Task Leader's knowledge and experience in conducting this rulemaking proceeding until it was placed IN HOLD on February 23, 1983. l
- 1. The issue to be addressed, i.e., the problem to be corrected.
The issue is the undertaking of a comprehensive review of the regulations in 10 CFR Chapter I (including 10 CFR Parts 30 and
- 32) to ensure that (1) the regulations, both individually and collectively, achieve the substantive goals set forth in the several statutes which direct the activities of the NRC; and (2) in accordance with Executive Order 12044 and the Regulatory Flexibility Act (Pub. L. 96-354), the regulations are as' simple and clear as possible, they achieve legislative goals effectively and efficiently, and they do not impose unnecessary burdens on the economy, on individuals, on public or private organizations, on small entities, or on state and local governments.
(46FR7388), January 23, 1981). (NOTE: Executive Order 12291, " Federal Regulation," of g February 17,1981, in Sec.10 revoked Executive Order 12044.) ' i l The staff's preliminary judgment is that completed and ongoing rulemakings since January 23, 1981, have adequately addressed the
- issue of a comprehensive review of the regulations in 10 CFR Parts 30 and 32. l l
l
\
l
-l The necessity and urgency for addressing the issue.
2. The original published schedule for review of the regulations in 10 CFR Part 30 was a final rule by September 1983; for review of the regulations in 10 CFR Part 32, a final rule by September 1985. Both schedules had the following caveat:
" Marketing of new products leads to ongoing consideration of revisions to this part. In addition, the review schedule is set to be consistent with planned studies of byproduct and source material in consumer products, general licensing uses, and specific licenses."
The subject planned studies are still underway. In the case of consumer products, the staff has an unpublished rule entitled,
" Revision of Consumer Product Approval Criteria and Regulations," - listed in the NRC Regulatory Agenda.
The staff's preliminary judgment is that the long-range nature of the schedules for the review of the regulations in 10 CFR Parts 30 and 32 and the planned studies of exemptions, general licenses, and specific licenses indicate there is no current necessity' or urgency for addressing the issue.
- 3. Alternatives to rulemaking.
l The issue to be addressed concarns the text of the regulations in 10 CFR Parts 30 and 32. The only way the text can be changed is 4 by rulemaking. Accordingly, there is no alternative to rulemaking. With regard to the periodic and systematic review, there are, however, two alternatives: (1) Rulemaking proceedings devoted exclusively.to revising the regulations in 10 CFR Parts 30 and 32 as a result of the periodic and systematic reviews; and (2) Laissez-faire, i.e., abstention from interference with individual choice and action. Alternative 1 was attempted during 1981 and 1982, but the task was placed in hold as of February 23, 1983, pending a management decision on the scope (major vs. minor) of revisions of the regulations. The task remains in hold. Since the criteria for periodic and systematic reviews of regulations were published on January 23, 1981 (46 FR 7388), several offices including RES, NMSS, ELD, and ADM have amended or are proposing to amend the regulations in 10 CFR Parts 30 and 32. The amendments cover a significant fraction of the sections in 10 CFR Parts 30 and 32.
Based on these factors, the staff's preliminary judgment is that Alternative.2, Laissez-faire, should be the way to proceed with the periodic and systematic review of the regulations in 10 CFR Parts 30 and 32.
- 4. How the issue will be addressed through rulemaking.
Under the preferred alternative (Laissez-faire), the issue will be addressed by the individual choices and actions of NRC staff during the course of conducting rulemakings initiated by the NRC at its own instance or on the petition of any other interested person. The staff's preliminary judgment is that continuing the present practice of various offices' amending the regulations in 10 CFR Parts 30 and 32 as the need arises will adequately address the issue of the periodic and systematic review.
- 5. How the public, industry, and NRC will be affected as a result of rulemaking, including benefits and costs, occupational exposure, and resources.
One of the principal reasons for placing the rulemaking tasks in hold in February 1983 was the need to resolve the question of balancing the estimated costs to the public, industry, and NRC for accommodating amendments to the regulations in 10 CFR Parts 30 and 32 to reap a marginal benefit such as, "5. The regulation is written in plain English and is understandable to those who must comply with it." The tasks remain in hold pending resolution of the questions. With no rulemaking proceeding devoted exclusively to revising the regulations in 10 CFR Parts 30 and 32 as a result of the periodic. and systematic reviews, the staff's preliminary judgment is that the. public and industry will not be affected as a result of the subject rulemaking. With regard to NRC, the resources expended on the periodic and systematic reviews in 1981 and 1982 are sunk costs. Any remaining costs to NRC are minor, but necessary, to take final action on the rulemaking.
- 6. NRC resources and scheduling for the rulemaking.
To proceed with the periodic and systematic review of the regulations in 10 CFR Parts 30 and 32 under Alternative 2, Laissez-faire, at minimum expenditure of resources, the staff should take final action on the subject rulemaking no later than publication of the NRC Regulatory Agenda, NUREG-0936, Vol. 3, No. 3 (Quarterly Report July - September 1984). The schedule for the Director, RES, to make recommendations to E00 for initial review of this ongoing rulemaking is by May 23, 1984. The staff will be unable to meet this date because of a requirement that the user office (NMSS) be allowed two weeks to consider the recommendations the Director, RES, will make to the EDO.
.' l In addition, RES will have to conduct an independent review of this on-going rulemaking. Procedures for RES independent review include 20 working days from time of receipt of a rulemaking to the date when the Director, RES, makes independent recommendations to the EDO. If NRC staff ,
arrives at a consensus to proceed under Alternative 2, Laissez-faire, ' RES staff could complete the independent review in about 30 staff-hours during the 20-working day review period. There is no basis for estimating NRC resources to .take final action on this rulemaking, but the estimate should be closer to the decade of 10 staff-hours than to 100 staff-hours. Accordingly, the staff's judgment is that NRC resources will be on the order of $2400 ($60/ staff-br. x (30+10) staff-br.) to review, approve, and publish an updated NRC Regulatory Agenda entry and to remove this rulemaking from NRC tracking systems. i
I l
- f. Copies of underlying documents.
Item I. 46 FR 7388 l Item 2. NUREG-0933, pp.4.IV.G-1 and.-2 1 r
W 7308 - Federal Register / Vol. 48, No.15 / Friday, knu:ry 23, 1981 / Proposed Rules Commission, Washington, D.C. 30555, telephone:(301) 443-5965. SUPPLassastramy sosponssATsoet On July
. 30,1980, the Commission published for public comment (45 FR 50613) the NRC Action Plan (NUREG-0600), a -
comprehensive and integrated approach for the correction and improvement of the regulation and operation of nuclear NUCLEAR REGULATORY facilities based on the experience gained COtsallSSION from the %ree Mile Island Unit No.2 accident.The Commission is now 10 CFR Cit.1 reviewing the comments. Task f/.G.2. of the NRC Action Plan requires a periodic Periodic and Systematic Review of and systematic reevaluation of existing RegulaHona NRC segulations and sets forth the AoEucy: Nuclear Regulatory Commission's commitment to comply Commission. with Executive Order 12044, Improving Government Regulations ** (3 CFR 152 - ACTsoet Notice of Comprehensive (1978)).His task, which is to be Review of Regulations and Request for completed within five years, calls for a Comments. detailed review of the entire body of
' NRC regulations in order to ensure that suestsARY:The Nuclear Regulatory (1) the regulations, both individually and
. Commission is undertaking a comprehensive review ofits regulations collectively, achieve the substantive 4 (10 CFR Chapter I) in order to ensure (1) ' goals set forth in the several statutes that the regulations, both individually which direct the activities of the and collectively, achieve the substantive Commission, including the Atomic s goals set forth in the several statutes - Energy Act of1954, as amended (42 which direct the activities of the U.S.C. I 2011, et seg.), the Energy Commission, including the Atomic Reorganization Act of 1974, as amended Energy Act of1954, as amended, the (42 U.S.C. I 5801, et seg.), the Administrative Procedure Act, and the Administrative Procedure Act (5 U.S.C.
National Environmental Policy Act: and i 500, et seg.) and the National (2) that, in accordance with Executive Environmental Policy.Act (42 U.S.C. Order 12044 and the Regulatory 4321, et seg.): and (2) that, in accordance Flexibility Act (Pub. L 96-354), the with Executive Order 12044 and the , regulations are as simpliand clear as Regulatory Flexibility Act (Pub. L 96 . possible, that they echieve Icgislative ' 354), the regulations are as simple and goals effectively and efficiently, ar.d clear as possible, that they achieve that they do not impose unnecessary - legislative goels effectively and burdens on the economy, on individuals, efficiently, and that they do not impose on public or private organizalions, on unnecessary burdens on the economy, , small entities, or on state and local on individuale, on public or private governments. Public comment is invited organiiations, on small entities or on upon the appmach to be used by the state andlocal governments. l In conducting this review the NRC
' Commission in conducting this review.
the structure and organization of 10 CFR will ensure that each regulation has Chapter I, and the interrelationship been evaluated for conformance with
.between and among parts withl'n 10 CFR the following criteria, set forth in ,
l . Chapter L Executive Order 12044: DATE:Com:nents period expires March 1.ne regulation is needed. 24,1981. .
- 2. Direct and Indirect effects of the ADoResses:Allinterested persons who regulation have been adequately considered.
desire to submit written comments or 3. Alternative approaches have been suggestions for consideration should considered and the least burdensome of the send them to the Secretary of the *CCePt able attematives haslyeen chosen. Commission, U.S. Nuclear Regulatory 4. Public comments have been considered s and adequate responses have been prepared.
. Commission Washington.D.C.20555,
- 5. De regulation is written in plain English s Attention: Docketing and Service and is understandable to those who must Branch. Copies of allcomments received may be examined in the Commission's - * "PYI "IO E- --
- 6. An esumate has bun made of &e .
Public Document Room at 1717 H Street reporting burdens or record k* ping NW., Washington, D.C. requirements necessary for compliance with l FOR FURTHER INFoRAsATION CONTACT: the regulation and submitted to GAO in , l L Craig Roberts, Office of Standards accordance with the Federal Reports Acts for Development U.S.NuclearRegulatory approvat . m
, . we Fn. M 8'
I Federal Register / W1. 46. Nr.15 / Friday, Jrnu;ry 23, 1981 / Propos.d Ruhs '7389 7.ne name, address, and telephone The NRC will undertake a st'udy of the h number of a knowledgeable agency official overall organization of 10 CFR Chapter It should be further noted that in conducting this review, the Commission l
/ has been provkled for each regulation. I, with an eye toward developing - has assigned highest priority to those '
- a. A plan for evaluating the regulation has been dmloped. options to remedy any organizational areas identified in the TMI Action Plan problems in the NRC's regulations. as most directly affected by the TMl In addition, all regulations which have In soliciting public comment on the accident. These include regulations or will haie a significant economic approach to be used in conducting this involving operator training, emergency impact upon a substantial number of review, the NRC wishes to emphasize planning, environmental monitoring, small entities will be reviewed in order that interested persons should focus radiation protection, and consistent to determine whether such rules should their comments on the structure and treatment of fission product release from be cpntinued without change, or should organization of10 CFR Chapter L fuel cladding failure. Recognizing that be amended or rescinded to minimize including the interrelationship between these areas are of most immediate any significant economic impact of the and among parts within ChapterI. concern, the NRC has developed a
' rules upon small entitles. As required by Opportunity to comment on specific preliminary schedule for conducting this
, the Regulatory Flexibility Act, this part provisions within to CFR will be review over the next five years, which
, of the review will focus on: provided at a later date.The NRC is includes estimated start and completion 1.ne continued need for the rule: particularly interested in any comments dates for individual parts and subparts.
- 2. The nature of complaints or comments the public may have with respect to This schedule is set forth in an received concerning the rule from the public: possible approaches to restructuring the attachment to this notice.
3.He complexity of the rule: regulations. The range of options
- 4. He extent to which the rule overlaps, Dated at Bethesda. Maryland. this soth day available for consideration is wide, of December.1980.
running the gamut from retaining the [ rule bo e ten fees b e. te current structure to undertaking a major For the Nuclear Regulatory Commission. and local governmental rules: and William J.Diicks, 5.ne length of time since the rule has revision of the entire structure of10 CFR Executive Directorfor Operations. U.S. been evaluated or the degree to which Chapter I. Eqch of these options, as well NuclearRegulatory Commission.
, technology economic conditions, or other as the entire midrange,is open for factors have changed in the area affected by comment. . ! the rule.
Schedule for Review of NRC Regulations 10 cFR Part and sue Start revlow corgiete gre. Putseh P@sh Remarks (necas year) emnary revow
- proposed ru e anal rule
, O conduct of Emplor= A- 1987
- None regared_ 9/82 1 Statemere of orgerustion and General information- 1981 None regared- 3/81 a Nee of Practce lor Domeetc Uconome peccesengs- 1984 9/6a 9/85 ,
4 Handecrtmrisson m Federapy Aeststed commemon Pro- Ongomo 12/81 6/s2 7 Commitises 1981 12/81 (') P) 9 Pec Records ongoing 7/81 2/82 10 Cmena and Procedures har ostermmme Engheny cor Ongomg 1/82 8/82 Access to Restncted Data er N42 anal Sewey inforrra-ecn 11 Qeens and Procadres for Detemannig Engotty tar 19e5 0/85 (') - I') RJe Recency @hed (11/21/80). . Access O cr Consod Over Specsal Nuclear Matenal (pro. .? 8 Mea 0 14 Aenensaraive Claims Urder rederer Tort clasms Act t 431 10.e2 : 12/82 it Notces, hseuceane, arid Reports to woAersianapoc. 1963 1/83 (') (') ~ cona e 20 Standards tor Protecton Agasiel Radenun ongC8"g 1U61 12/82 Mwance Notco of Rutsmaking putalehod Marth 20,
. . 1980 (45 FR 18C23).
21 Reparang 'Jf Duesets s'id Nctromchance 1982 4/62 f) P) 25 Access Authni+2saan tar Lk.ense Personnoi 1993 1.84 9/84 30 fhese of Gene ei 4p6cohhty e Domesac Licenseg of Cmgome 1/83 6/e1 Markenne of new pro & cts feeds to entrJing considere. t Sypmouct MaserteL tion of revisions to sus part m adcm ew seviser ' + echoose is est to to canustent weih ptenned stasse f _cf bygraduct and acwce metensi M cnraumer good-
. ucts. general scename unes. and spoofic konees.
31 Generet Domeone Lkenete car everoa,cs MaterteL ongoing e/s4 e/s5 Do. j $2 Spadec tasmeetc Uconnes to Manufacare or Transfer ongeing 9/64 0/85 Det certan noms contarung eypnxbc ustenmL 33 Spacchc Domesac Ucenues of Broad Scope cor Bypro4 Ongoing 8/83 (') (') s uce unterieL i 34 Uconses for Radoyephy and Raaston Safety Requre. Ongong 12/82 6/84 snares for Raeogapruc operaeorm - 35 Human uses of erprocket Maserna Ongeme s/82 6/83 40 Domeste Ucenomg of sasos Material Ongoing 9/84 9/85 ResJts of ongoing studes we affect schedutng of eue _ revtew. m adetm egnsscans amenenents to sus part were reconny made effecove 11/17/80.
$0 Domeetc Lkensmo of Producilon and Utitration Fach Ongovig See remarks _ Revision of Part 50 we hvorve numerous nAemaking ac-tea nons over e= penas 19eo 19s5.
BI Uconome and Regdatory Potcy and Procedres ear En- Ongoing 3/80 1/81 Nonce of proposed rulemakmg pdeshed March 3.1980 stronmensal ProtectorL (45 FR 13739k 65 operators' Ucensee Ongome 3/82 t') P) 80 n=rd of Eng%evel Rasoeceve wastes a r:=r*v=' ongomg 12/79. 3/81 - 1/81,12/88 Part 80 is a proposed new part 11 kwalves two separate Repoemones rulemalung accons. See noece of proposed rusomak. bg en acenomg Processee pddshed Decernbar 4
. 1979 (44 FR 70408) and achranced nonced of nae-
, malung on techncal crtterna pdeshed May 13,1979 (45 FR 31393).
- St Managemord and Deposal of Low-level wastes try Ongohg 4/81 - 9/82 Part 81 would be a new part See Advance Nohce of 9
shamow Land Bunal and Altameeve Chapcoal Methods Rulemalung p@ehad october 25.1978 (43 FR {prara--a 498 t t). 1 I
7300 Federal Resister / W1. 46. Ns.15 / Frkt:y, ):nuary 23, 1981 / Proposed Ruhs
- - N to Crn Pan sus see amt mese Ommesses pse- heash peesh Innumen pumas yee poury poeme
- proposed nos tud nos ,
ye ossemec umssung of syssest masser temastaf Orgeme elet e/es- tres The part us to momed me maned m separts asur se puted 4/st-e/e4, to be sangesand by e/e4. Ft puheems of M testutaf Ier Trwupon and Orgabg _ S/M Wet Proposed season pneenhed Angnet 17, te7e $44 fel Tswissertmann of ftmanessee tasas4mf hpuser Canum de234k Opusmuuk 72 usarame Amoesnieres Ier em Supees of Spera Fund h Cugspg 1t/e3 PJ P) si mampoisme apare Fuss anymee mensammes , ,. 7e resumes Pteamseen af Ptres med ^ n_ test 4/el4/ed- Sles lies put us to soveseed and codemd m siepens sier se panod eleth to to esmessend by e/e4 ' 7e essagemenenlemsmer of US/ teos e/se c) P) rue seonney ammund (12/eg l IAEA Ayement 1 81 test n/st ste2 i
.Sawisse a W tur se % of Puase 4 i es esswer Peseur Assoof mid sassoweeg of Demannel toes tles etes , i senser temmenon me meseired osmL '
too muscour ens t onoome Slot 8/ar h peoece of puomektg pimashed Asy so, sono i ito espotweassetof seneserFessneswastassetes tesi t/ss io/si 140 Fmansed Posenceen negeenises and Insiemrey Orgorg 3/94 12/e4 too end caerund nepasawy Ameer m orgame s/se (') (4
--m ,
te sumpamong en Omsvidemon peopsy test 3/s1 s/st 1M Fees sur Feosess erut testesses test it/s1 e/s2
*Fer omrtun puts, se need and schobde Imr revisione us to duesmened by sie prearnhary routsu. eNot yet sche Met an omr. === rn.d 1-==. e.g antase coot rose.es-es
.~.
9 . I i k 4 e b i
TASK IV.G: IMPROVE SAFETY RULEMAKING PROCEDURES The objectives of this task are to improve NRC rulemaking procedures to provide a greater opportunity for public participation, to assure a periodic and systematic reevaluation of NRC' rules, and to include appropriate provision for backfitting in all new regulations. (Item V.12 discusses related action < assessing the delegation of rulemaking authority to members of the staff.) ITEM IV.G.1: DEVELOP A PUBLIC AGENDA FOR RULEMAKING DESCRIPTION _ At the time NUREG-06604s was prepared, the NRC was issuing quarterly status reports on petitions for rulemaking and proposed rules and a status summary report listing those regulations under development by RES. Also published were advance notices of proposed rulemaking on major NRC actions. The TMI Action Plan *8 called for the publication of a semiannual agenda for significant rulemaking actions as required by Executive Order 12044. The cri-teria for determining significant regulations were to be developed by RES and the publication of the agenda was to be accomplished by ADM, after consultation ( with other program offices. The first semiannual regulatory agenda was ' published in the Federal Register 2s1 in October 1981 and subsequent publications were made in April and October 1982.2ss,2s4 Future publications of the agenda will be made in the Federal Register in April and October every year. This agenda describes the need and legal basis for each regulation and indicates the status of each regulation on the agenda (or previous editions of the agenda) until the issuance of final rules. This item is not directly related to safety and, therefore, is considered a licensing issue. CONCLUSION This Licensing Issue item has been resolved. ITEM IV.G.2: PERIODIC AND SYSTEMATIC REEVALUATION OF EXISTING RULES DESCRIPTION NRC will comply with the intent of Executive Order 12044, which requires a periodic and systematic reevaluation of existing rules and that regulations be written in plain english. NRC will first review its rules for content, quality, and clarity and, at a later date, will review the regulations as a body for proper structure. The initial review will concentrate on areas where rules are broadly affected by the accident at Three Mile Island. This initial review should be completed within five years and should be repeated every five years thereafter. , 3/31/83 4.IV.G-1 NUREG-0933
Since the thrust of this issue is directed at assuring that regulations are clearly stated and easily understood, there is no direct public or occupational s risk reduction which could be attributed to this item.
~
Resolution of this issue should result in less confusion and conflict in the preparation and review of license applications which, in turn, would result in . cost and time savings to both the industry and the NRC staff. I CONCLUSION This ites is a Licensing Issue. l ITEM IV.G.3: IMPROVE RULEMAKING PROCEDURES DESCRIPTION - NRC will reevaluate the rulemakir:2 process to ensure that it is properly focused on resolving important safety issues and that the procedures are clear, understandable, efficient, and well publicized. NRC will then consider a proposal to codify in NRC regulations and practice a procedure under which all new rules would include consideration of backfitting to existing plants. The establishment of the Committee for the Review of. Generic Requirements (CRGR) and the limited delegation of Commission rulemaking authority to the Office of the Executive Director for Operations 370 have implemented changes in the rule-
- making procedure which are in direct response to this issue. As a part of the i
revised process, value/ impact analyses 371 will be required for all proposed or final rules which would (a) likely have an effect on the economy of greater than
$100M in direct and indirect costs, (b) likely result in a significant adverse effect on the public health, safety or environment, or (c) result in a sub-I stantial ir. crease in cost or prices. Value/ impact analyses will include back-fitting considerations. In addition, the Regulatory Reform Task Force has recently recommended a change to the backfit rule (10 CFR 50.109) which would redefine the term "backfitting" as applied to those plants which have received a construction permit and would require an analysis to establish that backfitt-ing a new or revised requirement would result in a substantial increase in the protection of public health and safety.a72 This item is not directly related to public safety and, therefore, is considered a licensing issue.
CONCLUSION . This Licensing Issue has been resolved. ITEM IV.G.4: STUDY ALTERNATIVES FOR IMPROVED RULEMAKING PROCESS l DESCRIPTION ! NRC will study alternatives to the present rulemaking procedures for the purpose of improving the Commission's rulemaking efforts. 3/31/83 4.IV.G-2 NUREG-0933
1
- g. Assessment of the level of compliance by NRC staff with procedures and guidance.
Because the NRC staff could not resolve the question of the scope of the revisions of the regulations in 10 CFR Parts 30 and 32, the RES Task Leader limited the rulemaking to preliminary drafts of alternative text revisions. The rulemaking_never progressed to the point where ancillary requirements, e.g., preliminary draft regulatory analysis, regulatory flexibility analysis, supporting statement for paperiork reduction, or even a draft Federal Register notice, were needed. The rulemaking has remained in hold at a very early stage of the rulemaking proceeding since February 1983.
. 1 1
- h. Supplemental documentation.
- 1. Draft Task Control Fonn
- 2. Draft WITS update
- 3. Draft standard memorandum to ED0
1 e ' RY COMMISSION I AM NUMitH NRC Fsem 197) U.S. NUCLEAR EEOUL n m, TA!K CONTROL .! ga _ l[q-1 l l R A - 120 -l
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SFCY n0 CURR DDc: 12/31/44 CURR DAYS 3 +2s3 RFV 02 a E00 REF: TASM MA8tSt 820n55 UNIG SY8 r*iG DHE 12/31/na nwfG Days: ,241 e TYPE: HPnTD3 G40/01A e CURR DUE: 12/31/84 CUNR DAYS +243 REV 02 13/10/A3 RECVD3 START: COMPLg e URIG CONP(3 Ouft 12/31/a4 06t!G DAY 33 +p43 e DEsC EDO N0g 8NMt ' 8'E VISL h STAFF ESTIMATE OF ACCInLNT SOURCEe TERH BASIS 8 SECY NEP'u TO Ep0 3 29 82 RE 1 6 62 MEETING ON i AFFECTTHG sITINGe FflFRGCNCY PLANNI?sG & SFVFRE . 82 1 . i ( Af.CIDENT PR A TO HE COMPLETED IN in "nhTHS TOe 2 YLARS, StVE RE ACCIDEN T POLICY STA TEMENT. e HASIS: SECY HEND TO EDO 1 29.A2 RE l-6=42 PEETIHn D:1 R2=1 STATHS: = SEVERE ACCIDENT PULICY STATEMEN b 11/09/83: SEE STATUS REppHT ON SOURCE TLRM TO SECY 11 4 83, d3=
.....................................;................'.............2194 t fTEu Nn 829:30 CuaTACT: SENRY cuRR DME: o7/03/85 CHRW DAYS SFCY NO:
ee En0.REF: TASN BASISg 820:29 URIG SYs MIGIHM 30s REV 04 01/30/A3 nqIG Days .454 TYPE ( OPnTDs n4/2e/44 OECVn GAo/0!As e CURR DUET 07/01/83 CuMR DAY 8: 306 REve ce START: CowPLs e ORIG COMPL 00Es 01/30/83 OHIS DAV83 459 e btsC T' Hop 0SFD Rp(F . D EDO NO: SNMt - AWT 3n . PEW!no!C 1 SYSTFMATIC e HtEVALHAT!nn OF PAPTs 30 AND 32, e BASIS: NEGuLATUNY AGENDA . SEE SECY 82 76 BASIS: REGULATORY AGENDA = ' SEE SECY 62 70 s2/2M/n3 TAS* n2/09/a3 ON fiff (DC #45 6PPAoV6P WITHDRawsNG THis Auf/MAa: SNG /@M /uRC R6GutA T PLACEn TNT (I HnLD Ry TCF DTD 2/ n2/10/33: TCFHoln pEnoinG nECISfon o,s SCupE nF PART 3017/m3 PEP'9ING OFCISION ON SCUPE OF PART 30 REVIS!UNS 64 TING DREP ARED PL ACING TASM REVISIOMS. 01/18/R3: 12/02/P2 ST AFF Aw AITING 94HAGFMENT DECISints TN MHLn PENDING ON OECIS!nN ON SCOPE OF PART 30 REV!8 IONS scope nF REVISIONS , TASw LEADER A BRANCH CHIEF A 11/17/M23 FXTEN A 10/18/92: DIVIS!0N SIVE DIVISIH4 COMMENTS RECE1VED. RFSnLUTION OF C0"ENTS UNDENWAYRE NS NEEV httAT!d 10/05/42: h!VISInt, REVIEW REQUEST CIRCuLATF0 10/6)82: F r9/th/tt2 COMPLEft REVIEW REQUEST & oENDING s!GNATURE RY OIR/DRAOR RESPONSE RV !!/3/82 6M/17/M23 TASK LEAOLD PRopuSEn RULEMAMING PACwAGE OHF FROM CRESS 9/19/s2 HAS NEGUN DRAFTING PREAMRLF F0W RECODIFIED PART 30
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- 3. Form memorandum from user office
/*"D, t UNITED STATES
.' i NUCLEAR REGULATORY COMMISslON WASHINGTON, D.C. 20555 NAY 2 2 884 MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety and Safeguards FROM: Robert M. Bernero, Director Division of Risk Analysis and Operations Office of Nuclear Regulatory Research
SUBJECT:
DRAFT RECOMMENDATIONS TO ED0 CONCERNING WHETHER AND HOW TO CONTINUE WITH ONG0ING RULEMAKING SPONSORED BY RES Enclosed for your consideration are draft recommendations supported by a draft office review concerning whether and how to continue with an ongoing rulemaking sponsored by RES for which your office is identified as the user office. This memorandum constitutes my concurrence in the enclosed draft recommendations. I plan to dispatch this memorandum with the enclosed 4 draft recommendations to the Director, RES, two weeks from the above date. Please acknowledge receipt by returning this memorandum with or without comments on the draft recomendations as indicated below. Robert M. Bernero, Director Division of Risk Analysis and Operations Office of Nuclear Regulatory Research
Enclosure:
As stated (PeriodicandSystematic Reevaluation of Parts 30 and 32)
1
= '.~ l l
l MAY 2 21ll64 i Receipt acknowledged. No Comment. Receipt acknowledged. Co'mments as follows: t J Richard E. Cunningham, Dirfctor
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Division of Fuel Cycle and Material Safety. Office of Nuclear Material Safety and Safeguards i 4 1 i l
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