ML20217L020

Forwards Concurrence on Memo to Commissioner Curtiss

ML20217L020
Person / Time
Issue date:	10/21/1991
From:	Bernero R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
Shared Package
ML20217L002	List: ML20217K996 ML20217L007 ML20217L020 ML20217L029 ML20217L035 ML20217L044 ML20217L066 ML20217L759
References
FRN-56FR67011, RULE-PR-31, RULE-PR-32 AD34-1-054, AD34-1-54, NUDOCS 9708190012
Download: ML20217L020 (8)

Text

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3,. 1 NUCLEAR REGULATORY COMMISSION 8 WASHINGTON, D.C. 20666

+# OCT 211991 MEMORANDUM FOR: Eric S. Beckjord, Director Office of Nuclear Regulatory Research FROM: _ Robert h. Bernero, Director . , , _ ,

Office of Nuclear Material Safety and Safeguards.

SUBJECT:

CONCURRENCE ON MEM08tANDUM TO COMMIS$10NER CURTISS This Office concurs _with the proposed memorandum subject to the

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inclusion of the minor clarifying remarks indicated on the enclosed copy.

c-Robert M. Bernero, Director

. Office of Nuclear Material Safety and Safeguards

Enclosure:

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, . MEMORANDUM FOR:- Commissioner Curtiss l F . .

t M.-. Taylor, Executive Director for Operations FROM: James 1

SUBJECT:

_ PROPOSED AMENDMENTS TO 10 CFR PART 31, " GENERAL DOMESTIC-  !

LICENSES FOR BYPRODUCT MATERIAL," AND.10 CFR PART 32 C

" SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL (SECY-91-275) i :Your memorandum of October 4, 1991, requested the staff to respond to 11

questions which you felt needed answers prior to your voting on the subject .!

rulemaking. .The questions and their responses are provided below:

1 L 1. Question: How do the proposed changes relate to the provisions of 10 CFR Part 1507 For example, is the imposition of a general license on Agreement State distributors an exercise of 10 CFR 150.15(b)? In view

- of. the fact that Part 150 contains provisions relating to safeguards reporting by Agreement State licensees, should some reference to the proposed new Commission reporting requirements for specific Agreement

State licensees distributing generally licensed sources be added to Part 1507 Response: The primary praaosed change to 10.CFR 31.6, related to 4

10 CFR Part'150, wu'id c1Eify that, for devices described in 10 CFR 1

31.5, general licensees in Agreement States would not be subject to tha 180 day limitation specified in 10 CFR 150.20(b)(3). The-limitation applied.to the possession or use of radioactive materials, or other licensed activities, in non-Agreement States. The granting of a general  :

license to Agreement State distributors is not an exercise of 10 CFR 150.15(b) because the existing 10 CFR 31.6 already-provides for the 4- granting of a general license on Agreement State distributors and the.

proposed change would_not affect that.- The staff does not feel .that it is necessary to reference the new reporting requirements in 10 CFR Part '2

-150:since specific licensees in Agreement States:are expected to be-aware of the requirements in-10 CFR 31.6.

12.- 1 0uestion: The paper indicates that the rule will be a matter of c compatibility for Agreement. States. What-level _of compatibility? What

- specifically would the States be required-to adopt? Would the Agreement t

States-be= required to- follow up initially and periodically with all-

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recipients-initheir respective states to verify receipt of-sources and compliance +1th the terms of the general license?

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- Commissioner Curtiss 2 Resoonse: The'1evel of compatibility would be determined by the

. Commission following a recommendation by GPA's Office of State Programs.

At this time, the staff believes that the compatibility should be .

categorized in Division 2. However, if public comments from the  !

Agreement' States indicate that it should not be a Division 2. category, the staff may revise its. thinking. The Agreement States should adopt a_ ,

program of registratian 'anberification that is essentially the same as specified in the proposed rule and incorporate the necessary changes into their regulations. The Agreement States would follow up initially ,

and periodically with general licensees in their respective states to verify receipt of sources and compliance with the terms of the general license.

3. - Duestion: The paper indicates that the staff has coordinated the paper '

with the Agreement States and, where appropriate, incorporated their comments. What issues were raised by the Agreement States, what recommendations did the staff accept, and what recommendations did the staff reject?

Response: 'A draft of the proposed rule was given to GPA's Office of State Programs.who then distributed the document to the Agreement States. Comments from several states-were submitted to State Programs who then forwarded the comments to RES. The comments were reviewed and, wherea appropriate, were incorporated in the paper. Besides indicating general agreement with the concept of the proposed rule, the Agreement States raised the following specific points:

• Compatibility requirements should consider general licensee accountability systems currently in place in the Agreement States.

1

'

• Fees should be charged to general licensees to offset the cost of additional staffing required to administer the program.-

• There is no need for a standard format for submittal of information.

• The-requirements should become a matter of compatibility.

• There should be a raquirement to maintain the labeling on the devices.

• A definite bias was indicated by the inclusion of the Cobalt _60 teletherapy incident in the

Background:

section.

• In section 31.6(d), it is not clear to whom the phrase "each

- person" refers.

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l hJ M M d /~f.GJ kt- p .s y e o A cd n y stj h e u Commissioner Curtiss 3 bf#(M // dewed /M A Wr+ f f th All of the points raised were consi ered and accepted by the staff, -

except for the idea of charging a ee to general licensees to offset the cost of additional staffing and t 2 elimination of the use of a standard format for reporting information With respect to reporting information, licensees would be ven the option of not using the standard format provided all of the required information is included in their iapon L. -

4. Question: Is the computer the staff consider a natic 4g yfg /g g licenst :s?

Response: Yes, the currer

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data from the Agreement St response to a NRC inquiry, been obtaining records dit need NRC computer support #

national data base for the September 7, 1990, the Oft on the general licensees '

removed from the NRC data given to SP for distribut-data base it restricted to

5. Question: What are staff's plans regarding sources previously distributed? Are the pre-1975 sources footnoted in 10 CFR 31.5 for compliance with pre-1975 rules a special problem? If the old sources are transferred, would the new rule capture them? Are there other ways that these pre-1975 sources will become subject to increased regulatory oversight.

Response: The registration and verification system contained in the proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees including those who previously acquired radioactive sources.

10 CFR Part 31.5 has remained fundamentally unchanged since it was issued in 1959. The footnote concerning 1975 was added to allow the continued use of products that contained references to the Atomic Energy Commission (AEC) on their labels. In 1975 all references to the AEC were changed and a new zip code was added. Pre and post-1975 sources would all be treated the same and pre-1975 sources do not pose any special problem. If older sources are transferred, they would be subject to the same requirements as newer sources and the registration system would capture them. The pre-1975 sources would not become subject to any increased regulatory oversight beyond that of this proposed rule.

6. Question: How will we ensure that all licensees who will be subject to this rule, including those to whom sources were distributed decades ago, will be made aware of the requirements of the rule?

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l Commissioner Curtiss 4 Response: -The current NRC data base contains general licensees who -

acquired gauges as early as 1959. We have in the past sent Information Notices to general licensees. The implementation of the )roposed revisions to 10 CFR Parts 31 and 32, with the period of p1ased in contacts, will insure that each general licensee is provided with copies of the appropriate regulations, the general license, and a letter uplaining its responsibilities as a general licensee.

7. Question: Has the staff considered the results of the survey reported to the Commission in SECY-91-241 in formulating the recommendations contained in SECY-91-275, particularly the situation that existed with tritium light sources (1A, the apparent lack of control over sources sold primarily in 1989)? What, specifically, does the staff recommend to ensure that this situation is avoided in the future? ,

EnDonse: An early draft of the survey reported in SECY 91-241 was available when the recommendations in SECY 91-275 were formulated and the staff considered the results of the survey during preparation of the proposed rule. As indicated in SECY-91-241, "the survey continues to support the staff's conclusion that the mail tracking program, which will be the subject of a future Commission Paper, will improve general licensee awareness of compliance with regulatory requirements." The staff strongly believes that the proposed tracking system and the requirement to appoint a responsible person, along with inspector follow-up, should reduce the problems in this area including those associated with the tritium light sources.

8. Question: What type of NRC inspection and enforcement activities for distributors in Agreement States is anticipated for the new general license? What level of NRC resources is envisioned? Is it envisioned that the Agreement State issuing a specific license to manufacture and distribute sources will inspect against NRC's general license?

Runonse: The proposed new general license requirements would not change the current regulatory framework regarding the Agreement State licensees. There are no special inspection and enforcement activities planned for distributors in Agreement States. However, these distributors are also NRC general licensees pursuant to 10 CFR 31.6 and the proposed revisions would provide the NRC with more information about their identity and location. The current practice of' inspecting for cause or event related activities will continue and may involve a small increase in resources due to the additional information. This increase is included in the resource estimate provided in SECY-91-275.

9. Question: In view of the instances of poor reporting by NRC-licensed distributors, are additional inspection and enforcement efforts needed to ensure more comprehensive identification of recipients by distributors, in order to implement the notification provisions of this rule?

Commissioner Curtiss 5 Refponse: No additional inspection and enforcement actions are anticipated at this time because the staff believes that with improved registration and verification, and clearly written requirements, the chances of having unidentified device recipients will be greatly reduced. Furthermore, the revised rules and a more formal review of licensee reports will provide an improved basis for issuance of a Notice

-- of Violation for improper reporting of information to the NRC.

10. Dyestion: The Regulatory Analysis in Enclosure 3 examines only two alternatives: no action and the proposed reporting requirements. Why did the staff not discuss the option of specifically licensing some or all devices, particularly in view of the air gap rule currently being developed?

Resnonse: We did not consider the option of specifically licensing all of the devices to be a viable option in view of the large number of general licensecs. There are currently about 8000 specific licensees that require about 110 FTE at NRC to administer. We concluded that to specifically license 35,000 general licensees would involve several hundred additional FTE's. It was not considered appropriate to address such large resource needs given the staff's desire to improve the regulatory controls for general licensees but to keep the cost to a minimum. This very issue has been the subject of considerable discussioneamong the staff. Separate rulemakings, such as the Air Gap rulemaking, will address the costs of specifically licensing some generally-licensed products.

11. Question: The discussion of costs in Section 4.2 of Enclosure 3 does not include the cost associated with implementation of the rule by Agreement States. In view of the fact that this rule will become a matter of compatibility, would it be appropriate to include a discussion of such costs?

Resoonse: It is true that the discussion of costs in the Regulatory Analysis does not include the cost to the Agreement States associated with implementation of the rule. Only NRC implementation costs were included since they alone could be reasonably estimated. Agreement State costs would be difficult to estimate because we do not now know exactly how each Agreement State would implement the rule.

An acceptable method to roughly estimate the Agreement State costs can be to scale the NRC costs of implementing the rule for its 35,000 general licensees to estimate the costs for the approximately 70,000 Agreement State general licensees. The NRC costs for regulatory oversight, processing of enforcement actions, and inspection and 9

~ Commissioner Curtiss 6:

enforcement are about-7 FTE per year. Thus, the total Agreement State costs could be estimated to be about 14 FTE per year for all the 28-Agreement States.

James M. Taylor Executive Director j for Operations cc: The Chairman- ,

Commissioner Rogers Commissioner Remick SECY OGC 4

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• Commissioner Curtiss 6 enforcement are about 7 FTE >er year. Thus, the total Agreement State costs could be estimated to se about 14 FTE per year for all the 28 Agreement States.

James M. Taylor b Executive Director for Operations cc: The Chairman Commissionar Rogers 1

Commissioner Remick SECY OGC -

Distribution:

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• • • • • OCT 2 81991 MEMORANDUM FOR: Commissioner Curtiss FROM: James M. Taylor, Executive Director for'0perations

SUBJECT:

PROPOSED AMENDMENTS 1010 CFR PART 31, ' GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL,' AND 10 CFR PART 3?,

' SPECIFIC DOMESTIC LICENSES TO MANUFACTURF OR TRANSFER i CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL (SECY-91-275)

I ,

Your memorandum of October 4, 1991, requested the staff to respond to 11 questions which you felt needed answers prior to your voting on the subject rulemaking. The questions and their responses are provided below:

l. QuullDD liow do the proposed changes relate to the provisions of 10 CFR Part 1507 for example, is the imposition of a general license on Agreement State distributors an exercise of 10 CFR 150.15(b)? In view of the fact that Part 150 contains provisions relating to safeguards reporting 6by Agreement State licensees, should some refersnee to the proposed new Commission reporting requirements for specific Agreement State licensees distributing generally licensed sources be added to Part 1507 Bunanie: The primary proposed change to 10 CFR 31.6, related to 10 CFR Part 150, would clarify that, for dev 4es described in 10 CFR 31.5, general licensees in Agreement States would not be subject to the 180 day limitation specified in 10 CFR 150.20(b)(3). The limitation applied to the possession or use of radioactive materials, or other licensed activities, in non-Agreement States. The granting of a general license to Agreement State distributors is not an exercise of 10 CFR :

150.15(b) because the existing 10 CFR 31.6 already provides for the granting of a general license to Agreement State distributors and the proposed change would not affect that. The staff does not feel that it is necessary to reference the new reporting requirements in 10 CFR Part 150 since NRC State Programs will work with the States to assure a>propriate cross-reference to 10 CFR 31.6 and 32.52 are incorporated in tie State regulations or licenses.

2. Question: The paper indicates that the rule will be a matter of compatibility for Agreement States. What level of compatibility? What specifically would the States be required to adopt? Would the Agreement States be required to follow up initially and periodically with all recipients in their respective states to verify receipt of sources and compliance with the terms of the general license?

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O Comissioner Curtiss 2 Response: The level of compatibility would be determined by the Comission following a recomendation by GPA's Office of State Programs. l At this time, the staff believes that the compatibility should be categorized in Division 2. This level of compatibility requires that States address provisions in NRC regulations relating to basic principles of radiation safety and regulatory functions without  !

necessarily using identical lave ."stes may also adopt j requirements more restrictive than NRC rules under this level of 1 l

compatibility, llowever, if public coments from the Agreement States indicate that it should not be a Division 2 category, the staff may revise its thinking. The Agreement States should adopt a program of registration and verification that is essentially the same as specified in the proposed rul6 and incorporate the necessary changes into their regulations. The Agreement States would follow up initially and periodically with general licensees in their respective states to verify receipt of sources and compliance with the terms of the general license.

3. Question: The paper nl'dicates that the staff has coordinated the paper with the Agreement States and, where ap)ropriate, incorporated their coments. What issues were raised by tie Agreement States, what recommendations did the staff accept, and what recomendations did the staff reject?

Responte:4 A draft of the proposed rule was given to GPA's Office of State Programs who then distributed the document to the Agreement States. Comments from several states were submitted to State Programs who then forwarded the coments to RES. The coments were reviewed and, where appropriate, were incorporated in the paper. Besides indicating general agreement with the concept of the proposed rule, the Agreement States raised the following specific points:

- Compatibility requirements should consider general licensee accountability systems currently in place in the l"reement States.

- fees should be charged to general licensees to offset the cost of.-

additional staffing required to administer the program.

- There is no need for a standard format for submittal of information.

- The requirements should become a matter of compatibility.

- There should be a requirement to maintain the labeling on the devices.

- A definite bias was indicated by the inclusion of the Cobalt 60 teletherapy incident in the Background section.

- In section 31.6(d), it is not clear to whom the phrase "each person" refers.

4

.f Commissioner Curtiss 3 All of the points raised were considered and accepted by the staff, I except for the idea of charging a fee to general licensees to offset the cost of additional staffing and the elimination of the use of a standard format for reporting information. The staff intends to address the issue of charging fees to general licensees in a future paper. With respect to reporting information, licensees would be given the option of not using the standard format provided all of the required information is included in their report.

4. Dunihn: Is the computerized data base limited to NRC licensees? Did the staff consider a national computerized data base for all general licensees?

Bupmin: Yes, the current data base is limited to NRC licensees. A national computerized data base was established in 1985 by the NRC and data from the Agreement States was provided to the NRC. Sinc ~e then, in response to a NRC inquiry, the Agreement States indicated that they have been obtaining records directly from distributors and that they do not need NRC computer support for this purpose. They do not require a national data base for their regulatory programs. As a result, on September 7, 1990, the Office of State Programs (SP) indicated that data on the general licensees located in the Agreement States could be removed from the NRC data base. The data was put on flo)py disks and giventogPfordistributiontotheAgreementStates. T1e current NRC data base is restricted to only NRC general licensees.

5. Question: What are staff's plans regarding sources previously distributed? Are the pre-1975 sources footnoted in 10 CFR 31.5 for compliance with pre-1975 rules a special problem? If the old sources are transferred, would the new rule capture them? Are there other ways that these pre-1975 sources will become subject to increased regulatory oversight.

Resoonse: The registration and verification system contained in the proposed amendments to 10 CFR Parts 31 and 32 will include all general .

licensees including those who previously acquired radioactive sources. ~

10 CFR Part 31.5 has remained fundamentally unchanged since it was issued in 1959. The footnote concerning 1975 was added to allow the continued use of products that contained references to the Atomic Energy Commission (AEC) on their labels. In 1975 all references to the AEC were changed and a new zip code was added. Pre and post-1975 sources would all be treated the same and pre-1975 sources do not pose any special problem, if older sources are transferred, they would be subject to the same requirements as newer sources and the registration system would capture them. The pre-1975 sources would not become subject to any increased regulatory oversight beyond that of this proposed rule.

6. Question: How will we ensure that all licensees who will be subject to l this rule, Scluding those to whom sources were distributed decades ago, will be made aware of the requirements of the rule?

l I

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Comissioner Curtiss 4 Ettnant: The current NRC data base includes identification of general After implementation of licensees who acquired gauges as early as 1959.

the proposed revisions to 10 CFR Parts 31 and 32, the staff will begin to provide these as well as future general licensees with copies of the appropriate regulations and letters explaining their responsibilities.

7. DasHant As the staff considered the results of the survey reported to the Commission in SECY-91-241 in formulating the recommendations contained in SECY-91-275, particularly the situation that existed with tritium light sources (1A, the apparent lack of control over sources sold primarily in 1989)7 What, specifically, does the staff recomend to ensure that this situation is avoided in the future?

Response: An early draft of the survey reported in SECY 91-241 was available when the recommendations in SECY 91-275 were formulated and the staff considered the results of the survey during preparation of the proposed rule. As indicated in SECY-91-241 the survey continues to supportthestaff'sconclusionthatthemailtrackingprogram,which will be the subject of a future Commission Paper, will improve general licensee awaren6ss of compliance with regulatory recuirements.' The staff believes that the proposed tracking system anc the requirement to appoint a responsible person, along with ins)ector follow-up, should reduce the )roblems in this area including tiose associated with the tritium 14 git sources.

8. Question: What type of NRC inspection and enforcement activities for distributors in Agreement States is anticipated for the new general-license? What level of NRC resources is envisioned? Is it envisioned that the Agreement State issuing a specific license to manufacture and l

distribute sources will inspect against NRC's general licensef Resoonse: The proposed new general license requirements would not l change the current regulatory framework regarding the Agreement State licensees. There are no special inspection and enforcement activities planned for distributors in Agreement States. However, these ,

distributors are also NRC general licensees pursuant to 10 CFR 31.6 and the proposed revision would provide the NRC with more information about their identity and location. The current practice of inspecting for cause or event related activities will continue and may involve a small increase in resources due to the additional information. This increase is included in the resource estimate provided in SECY-91-275.

9. Ruestion: In view of the instances of poor reporting by NRC-licensed distributors, are additional inspection and enforcement efforts needed to ensure more comprehensive identification of recipients by distributors, in order to implement the notification provisions of this rule?

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Comissioner Curtiss 5 Response: No additional inspection and enforcement actions are ,

anticipated at this time because the staff believes that with improved registration and verification, and clearly written requirements, the chances of having unidentified device recipients will be greatly reduced. Furthermore, the revised rules and a more formal review of licensee reports will provide an improved basis for issuance of a Notice of Violation for improper reporting of information to the NRC.

10. Dunitical: The Regulatory Analysis in Enclosure 3 examines only two alternatives: no action and the proposed reporting requirements. Why did the staff not discuss the option of specifically licensing some or all devices, particularly in view of the air gap rule currently being developed?

EtiPADic: We did not consider the opte e, gecifically licensing all of the devices to be a viable option in o W N the large number of general licensees. There are currently no.,a @ 00 specific licensees that require about 110 FTE at NRC to administer. We concluded that to specifically license 35,000 general licensees would involve several hundred additional TTE's. It was not considered appropriate to address such large resource needs given the staff's desire to improve the regulatory controls for general licensees but to keep the cost to a minimum. This very issue has been the subject of considerable discussion among the staff. Separate rulemakings, such as the Air Gap rulemaking, will address the costs of specifically licensing some generally-licensed products.

11. Question: The discussion of costs in Section 4.2 of Enclosure 3 does not include the cost associated with implementation of the rule by Agreement States, in view of the fact that this rule will become a matter of compatibility, would it be appropriate to include a discussion of such costs?

RelP.Datt: It is true that the discussion of costs in the Regulatory Analysis does not include the cost to the Agreement States associated ,

with implementation of the rule. Only NRC implementation costs were included since they alone could be reasonably estimated. Agreement State costs would be difficult to estimate because we do not now know exactly how each Agreement State would implement the rule.

An acceptable method to roughly estimate the Agreement State costs can be to scale the NRC costs of implementing the rule for its 35,000 general licensees to estimate the costs for the approximately 70,000 Agreement State general licensees. The NRC costs for regulatory oversight, processing of enforcement actions, and inspection and

Comissioner Curtiss 6 enforcement are about 7 FTE >er year. Thus, the total Agreement State costs could be estimated to se about 14 FTE per year for all the 28 Agreement States.

Original Sirned Dp hma 1.1. Taylot ,.

James M. Taylor Executive Director for Operations cc: The Chairman Comissioner Rogers Comissioner Remick SECY OGC Distribution: (CURTIS.NEM)

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-MEMORANDUM FORT James M. Taylor Executive Director for erations FROMt Samuel J. Chilk, Secret SUBJECT! SECY-91-275 - PROPOSED Et DMENTS TO 10 CFR PART 31, " GENERAL DOMES CJLICENSES FOR BYPRODUCT MATERIAL," AN. 10 CFR PART 32,

" SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL" The Commission (with all Commissioners agreeing) has approved issuance of the proposed amendments to 10 CFR Parts 31 and 32 as a proposed rule subject to the changes in the attachment.

-fEDO-)- (RES) (SECY Suspense 12/20/91) 8900090 The followi'ng comments are provided:

1) The discussion of Agreement State licensees and regulatory

programs in the Statements of Consideration should be amplified to reflect the staff responses to several of Commissioner Curtiss' questions. See the insert on page 5 ,

of the notice.

. 2) The regulatory framework and applicability to older sources should be added the Statements of Consideration consistent with the staff responses to commissioner Curtiss' questions 5 and 6. See the insert on page 7 of the notice.

3) on page 6, the discussion of potential changes to the scope of general-licensed devices should be deleted. Mentioning the possibility of future such changes is_not relevant to these amendments at this time and the proposed language would likely cause confusion.

4) The letters to Congress should be modified as shown in the attachments to be more consistent with the summary and background sections of the notice.

SECY NOTE: THIS SRM, SECY-91-275, AND THE VOTE SHEETS OF THE CHAIRMAN, AND COMMISSIONERS ROGERS AND CURTISS WILL BE MADE PUBLICLY AVAILABLE 10 WORKING DAYS FROM THE.DATE OF THIS SRM O $- O kkf i > l, ,

5) The staff response to commissioner Curtiss' questions 8 and 9 indicato that no special monitoring or inspection of how Wall manufacturers and distributors may be complying with the now reporting requiroments is anticipated. He plans to revisit the complianco issue when the final rule is submitted for Commission approval.

Attachment:

As stated cc: The Chairman Commissioner Rogers Commissioner Curtiss Commissionar Romick OGC 01G 4

storage of devices in warehouses, disposal in scrap yards, incineration of waste, melting in a smelter, and disposal in a landfill. Included in the risk l

assessment was an incident at a ste61 company in 1983 (discussed in NUREG- l 1188, "The Auburn Steel Company Radioactivs Contamination Incident") th:t- - I ptobably represents a worst-case scenario for generally licensed gauging devices. Although individual doses were low and within aforementioned limits for exposure of members of the public, they nevertheless represent unnecessary additional public exposure that could have been avoided. In addition, the cleanup costs were in excess of four million dollars with additional costs incurred for the staff efforts of regulatory agencies, in consideration of both the risk assessment and incidents like those noted above, the NRC conducted a three-year sampling (1984 thru 1986) of generallicensies(takenfromthevendors'quarterlyreports)todetermine whether there was an accounting problem with gauge users under general licenses, and if so, what remedial action might be necessary. The sampling was conducted both by telephone calls and site visits. The sampling revealed several areas of concern about the use of radioactive material under the general license provisions. On the basis of the sampling, the NRC concluded that there is (1) a lack of awareness of appropriate regulations on the part of the user (general licensee) and (2) inadequate handling and accounting for these generally licensed devices. The NRC further concluded that these'two problems could be remedied by more frequent and timely contact between the general licensee and the NRC. This conclusion by the NRC provides the basis for the regulatory changes proposed in this action.f Th

[ mhteuf._c m atibil y for T would a34 reement St tes. The Agree ' tates t -

par 14eip ed in the deve pmenLof- th s ru e, es o he proposed le gg g 5 Enclosure

Insert A, page 5 An estimated 70,000 Agreement State licensees use the types of cources and devices covered by the amendments being proposed today for NRC's general licensees. Consequently, the States will play an important role in achieving improved regulatory oversight on a national basis. Many of the States already have accountability programs in place. The Agreement States participated in the development of this ru.la and.. indicated agreement with the concept of the proposed rule. Specific comments from the Agreement States were adopted except for suggestions that NRC charge general licensees fees and that there is no need for a standard format for submitting information. The fee issue will be addressed separately. The proposed rule provides flexibility in the use of the standard format.

The Commission is considering making the amendments a matter of compatibility for the States. NRC staff has suggested that the amendments be categorized as Division 2 level of compatibility.

This level of compatibility requires that States address provisions in NRC regulations relating to basic principles of radiation safety and regulatory functions without necessarily using identical language. States may also adopt requirements more restrictive than NRC rules under this level of compatibility. The NRC would appreciate comments on this suggestion.4 T

4

..,,m:. _ - _ _ _..,_ .

W were circulated to the Agreement States, They have supported the rulemaking and all their comments were considered and incorporated as appr riate.

The ris ssess'wnt and the sampling above also led the mission to 4 conclude that for small group (a few hundred) a# gener y licensed gassa gauges the radiation r- , though small in an absolu sense, may be sufficient to warrant their nyersion to specif licenses. In addition, there also appears to be anothe , larger gr p of generally licensed devices (about 10,000) where the radiation r s estimated to be very low. These devir.es, e.g., beta backscatter ga es an nalytical devices may be candidates for exemption-from rther regulati under the Commission's BRC Policy. The Commission i considering these action This proposed regulation addresses e vast majority of generally lice ed devices that fall 4

in the middle of e risk spectrum. For these devices, the r k is small to the extent t t specific licensing can not be justified. Butneithrisitso small, ecially in consideration of the very large numbers of such devices j (ext t, that exemptions would appear to be appropriate. f An estimated 35,000 persons use certain measuring, gauging, or IStt.'s controllingdevicesunderpgenerallicense. NRC regulations that affect these general-licensees' responsibilities and that are presently being amended are 10 CFR 31.2, 31.4, 31.5, and 31.6. Under 10 CFR 31.2, " Terms and Conditions," all general licensees are subject to certain provisions of Part 30 and also Parts 19, 20, and 21. The proposed revision to 5 31.2 would also subject all general licensees to the requirements of 10 CFR 30.9,

" Completeness and ' curacy of Information," which imposes certain requirements regarding t 'ompleteness and accuracy of the information submitted to NRC by licensees nt aow imposed upon general licensees.

6 Enclosure

. ~ - _ . .- . .- . - . - .--- .- - . - _ . - - . - . - - . - _ -

_. - - -_ --. ~ _ _ - _ _ _ _ . - . - - . _.__--- . _ _ _ _ - .

t Section 31.4 of 10 CFR Part 31, "Information Collection Requirements:

OMB approval," lists the various sections of Part 31 that contain approved information collection requirements. Paragraph b of 5 31.4 is being amended to add 5 31.6 to the approved listing.

Section 31.5, "Certain measuring, gauging or controlling devices,"

provides for a general licensee to acquire, receive, possess, use, or transfer byproduct materials. It also specifies the responsibilities of general licensees regarding the use of byproduct materials. Under the proposed

revisions a new paragraph (c)(11) would be added to require the general i licensee to provide specific information to the NRC upon request. This information would include the complete name and address; specific information about the device, such as manufacturer, model number, and number of devices; name, title, Ahd telephone nu6er of the person responsible for contro11teg the use of the device; the address where the device is located or used; and whether the specific requirements of paragraph (c) of 5 31.5 have been met, in addition, a proposed revision to paragraph (b) of 5 31.5 would delete all references to specific licenses issued by Agreement States that authorize distribution of devices to persons generally licensed ty Agreement States.

1H5EET .-,.

g At present, 10 CFR 31.6, " General license to install devices generally itcensed in i 31.5," provides a general license to certain specific licensees from Agreement States to install or service devices used under i 31.5. The current regulation,10 CFR 31.6, is not clear with respect to time restrictiors. Paragraph 150.20 (b)(3) of 10 CFR Part 150 imposes a 180-day-per-calendar-year limitation on the activities of Agreement State Licensees in r.on-Agreement States. The proposed amendments to i 31.6 would remove this restriction for i 31.5 licensees. This change will be convenient to the NRC, 7 Enclosure

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Insert B, page 7 The registration and verification system contained in the

• proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees, including those who previously acquired radioactive sources. If older sources are transferred, they would be subject to the same requirements as newer sources and j the registration system is intended to capture them. General ,

licensee transfers of sources are limited to either transfer to i specific liceiisees or other general licensees by the existing provisions of 10 CFR 31.5(c)(8) and (9) .

licensees must notify NRC of the transfers.In both cases,ific If the spec licensee is a 10 CFR Part 32 or Agreement State equivalent distributor, the reporting requirements of the proposed rule would apply to any subsepent transfers. The current NRC data base, although limited, includes identification of general licensees who acquired gauges as early as 1959. NRC staff plans to contact these licensees and any new general licensee as part of the enhanced oversight effort.

a

84

/pa re:q# o #

',, UNITED STATES I% ,,, a NUCLEAR HEGUt.ATORY COMMISSION

!. l nsm90 Tow, o. c. rosss

\,...../

e The Honorable Bob Graham, Chairman Subcommittee on Nuclear Regulation 0:=aittee on Environment and Public Works United States Senate Washington, DC 20510

Dear Mr. Chairmen:

Enclosed for the information of the subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal _ Register. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is pro)osing to amend these regulations to require the general licensees to provide t1e NRC with specific information about the licensed devit:es. Corresponding changes would also be made in 10 CFR Part 3: on the transfer reporting requirements imposed on persons authorized to distribute byproduct material.J These ch>ng are being made because th e is7 L Ina qquate account 1,og T generally 1 (ensed ces, and also a . al lack of awl ss of h'e appro te re ations on t rt of ral licensees, it is pMdiente the 3rdpose 4s will e e tha ese two problems

[are remedied by more t elf contact between,th general licens t-and the NRC.)

Ik15tRT C. Sincerely, 9 q <7 i i d J. i  %

Eric S. Beckjord trector Office of Nuclear egulatory Research

Enclosure:

Notice of Proposed Rulemaking ec: Senator Alan K. Simpson a- .-.a.m.- " ~~

l l

• l Insert C, Congressional Letter l Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience. The general licensee is required to comply with the safety instructions provided and to have all servicing done by persons with appropriate experience who are licensed to perform the service. In order to evaluate the effectiveness of the general liennse program, we have conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulaton oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Through these actions, NRC will be able to provide greater assurance,that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiativn exposure to the public.

4 4

4

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Ab 34sl l l

PBR tlEC 6 1991 i

NOTE 10: Margo Bridgers, Chief  ;

Administration and Corrections Branch i FRON - Sher Bahadur, Chief . . .  ?

Regulation Development Branch i

SUBJECT:

SIGNATURE ON FEDERAL REGISTER N011CE Attached is the Federal Regjitar notice and the Congressional Letters that  !

have been modified per SECY SRM dated I;ovember 29,1991(attached).- The  !

federal Reatster notice also includes minor editorial changes suggested by the >

Regulatory Publications Branch (RPB). The SRM changes and the RP8 changes have been comb 8ned into a markup document which is also attached. The final FRN and the Coagressional letters have been reviewed by RPB and they concur with the changes. Please call Joe Mate at extension 23795 when the FRN has i been signed.

Thank you, 4

E^ a '

Sher Bahadur, Chief Regulation Development Branch  :

Attachments:

l. federal Reaister Notice

~

2. Congressional Letters

3. SRM

, 4. Markup Document  ;

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ATTACl1 MENT 1 4

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[7590-01) 1 I

NUCLEAR REGULATORY COMMISSION l t

_10 CFR Parts-31 and 32  !

+

i RIN 3150 - AD34  :

i I

' Requirements for the Poss,ession of Industrial.  ;

Devices Containing Byproduct Material  !

J t

AGENCY:

, Nuclear, Regulatory Commission. ]

ACTION - Proposed rule.-

. t Sul#ERY: The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the safe use of byproduct material in certain measuring.

• t

. gauging, or controlling devices.. The proposed changes, among other things, would require general licensees who possess these devices to provide the NRC {

inf'ormation about the-identification of devices and the. people responsible for l

i the' devices. Further, specific licensees who are distributors of generally  ;

licensed devices under 10 CFR 31.5 would' be required-to use a unifom format'  ;

i when submitting the quarterly transfer . reports to NRC. The proposed. rule is intended to ensure that general' licensees are aware of and understand the [

e requirements:for the possession of devices containing byproduct material.

This awareness will better assure that general licensees will comply with_the i

3

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__g

~ ~ . . - . . . .. - _ - _ . - , - . _ . . _ _ - . , - - ~ , . , _ - . ~ . - - , . , - . - - . . , _ _ . . .

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____-_-_ _ _ _ _._._ m. _

I requirements for proper handling and disposal of generally licensed devices 4 and presumably reduce the potential for incidents that could result in unnecessary radiation exposure to the public..

DATE: Ihe comment period expires 75 days after publication. Comments received after this date will be considered if it is practicable to do so, but

~

the NRC is able to ensure consideration only for comments received on or before this date, ,

ADDRESSES: _ Mail wr'itteil comments to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.

Deliver commentg to One White Flint North,11555 Rockville Pike, Rockville, MD, between 7:30 am and 4:15 pm on weekdays. Copies of the draft regulatory analysis, as well as copies of the comments received on the proposed rule, may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower level),

Washington, DC.

TOR FURTHER INFORMATION CONTACT: Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3795.

t

i

$UPPLEMENTARY INFORMATION

• i l

Backg tund  ;

. i on February 12, 1959;(24 FR 1089), the Atomic Energy Commission amended its' regulations to provide a general license for the use of byproduct material ,

contained in certain luminous, measuring, gaug'. g, and controlling devices.  :

"nder the current requirements for possession of a general license,'certain 1

ptsons may receive and use a device containing byproduct material if the  ;

device has been manufactured and distributed in accordance with the l specifications contained in a specific license issued by the NRC or by an r Agreement state., A specific license is issued based upon a detemination by a regulatory authority that the safety features of the device and the

' instructions for safe operation are adequate and meet regulatory requirements. ,

.The general licensee is required to comply with the safety instructions.  ;

contained in or referenced on the label of the device and.to have the testing or servicing of the device performed by an individual authorized to I manufacture, install, or service these devices. A generally licensed device _

is a " black box " that is, the radioactive material is contained in a _ sealed ,.

source usually within a shielded device. The device is designed with inherent  :

radiation safety. features so that it can be used by persons with no radiation

~

i training or-experience. Thus, the gener'al license policy is a mechanism to simplify th'e license process'so-that a case-by-case determination of the Ladequacy of the radiation training or experience of each user is not  !

i

necessary. .

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Discussion There are about 600,000 devices that contain byproduct material in use by about 35,000 licensees under the Commission's general license regulatory program. General licensees have not been contacted by NRC on a regular basis because of the relatively small radiation risk posed by generally licensed devices. These devices have survived fires and explosions on many occasions without a total loss of shielding. They have been damaged by molten steel, and hit by construction vehicles with only minor losses in radiation shielding while maintaining the integrity'of the source capsule.

Nonetheless, there have been a number of occurrences where devices containing radioactive material have not been properly handled or disposed of ,

e and resulted in radiation exposure of the public. Although no significant  :

public health and safety hazards resulted from these incidents, if proper handling and disposal procedures had been followed, these avoidable exposures would not have occurred. For example, one or more cesium-type gauges were mixed in with some scrap metal that was melted down to form steel and the entire batch of steel was contaminated. In another instance, a static eliminator bar with 22.5 millicuries of americium-241 was sent to a sanitary landfill over which the NRC has no jurisdiction. There have been other types of incidents' involving NRC generally licensed devices including damaged devices, leaking or contaminated sources', and equipment malfunctions. 'i However, loss of accountability. as occurred above, remains the most frequen incident and the predominant concern.

Because of these occurrences, the NRC's Office of Nuclear Material Safety and Safeguards-(NMSS) conducted a radiological risk. assessment addressing ,

4

-e,-,

I I

storage of devices in warehouses, disposal in scrap yards, incineration of l waste, melting in a smelter, and disposal in a landfill. NNSS included in the l l risk-assessment an incident at a steel company in 1983 (distessed in NUREG-1188,"TheAuburnSteelCompanyRadioactiveContaminationIncident")that j probably represents a worst-case scenario for generally licensed gauging l i

devices. Although individual. doses were low and within prescribed limits for j exposure of members of the public, they nevertheless represent unnecessary  ;

additional public exposure that could have been avoided. in addition, the  !

- . cleanup costs were in excess of four million dollars with additional costs f incurred for the staff efforts of-regulatory agencies.  ;

In consideration of both the risk assessment and incidents like those  ;

1

. noted above, the NRC conducted a three-year sampling (1984 thru 1986) of e

general licensees (taken from the vendors' quarterly reports) to determine .

whether there was an accounting problem with gauge users uader general l licenses, and if so, what remedial action might be necoslary. The sampling-f was conducted both by telephone calls and site visits. (he sampling revealed  !

several areas of concern.regarding the use of radioactive material under the  ;

l general license provisions. On the basis of the sampling, the NRC concluded l that there ist (1) a lack of awareness of appropriate regulations on the part.

~

of the user-(general-licensee)-and'(2). inadequate handling and accounting for these-generally 1.icensed devices. The NRC further concluded that these two- r problems could be remedied by.more frequ'ont and timely contact between the' general licensee and the.NRC. This conclusion by the NRC provides the basis

.for the regulatory changes proposed in this action.

l.

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a,sa,

An estimated 70,000 Agreement State licensees use the types of sources and devices covered by the amendments being proposed today for the NRC's general licensees. Consequently, the States will play an important role in achieving improved regulatory oversight on a national basis. Many of the States already have accountability programs in place. The Agreement States participated in the development of this rule and indicated agreement with the concept of the proposed rule. Specific comments from the Agreement States were adopted except for suggestions that the NRC charge general licensees fees ,

and that there is no need for a standard format for submitting information.

The fee issue will be addressed separately. The proposed rule provides flexibility in the use of the standard format.

The Commiss, ion is considering making the amendments a matter of compatibility for the States. The NRC staff has suggested that the amendments be categorized as Division 2 level of compatibility. This IcVel of compatibility requires that States address provisions in NRC regulations relating to basic principles of radiation safety and regulatory functions without necessarily using identical language. States .may also adopt requirements more restrictive than NRC rules under this level of compatibility. The Commission would appreciate comments on this suggestion.

An estimated 35,000 persons use certain nieasuring, gauging, or controlling devices under the NRC's general license. NRC regulations that affect these general licensees' responsibilities and that are presently being amended are 10 LSD 11.2, 31.4, 31.5, and 31.6. Under 10 CFR 31.2, " Terms and Conditions," all general licensees are subject to certain provisions of Part 30 and also Parts 19, 20, and 21. The proposed revision to i 31.2 would also 6

e l

I l

subject all general licensees to the requirements of 10 CFR 30.9,

" Completeness and Accuracy of Information," which imposes certain requirements regarding the completeness and accuracy of the information submitted to the NRC by licensees not now imposed upon general licensees.

Section 31.4 of 10 CFR Part 31, "Information Collection Requirements:

OMB approval," lists the various sections of Part 31 that contain approved information collection requirements. Paragraph (b) of 5 31.4 is being amended to add i 31.6 to ao approved listing. ,

Section 31.5, "Certain measuring, gauging or controlling devices,"

provides for a general licensee to acquire, receive, possess, use, or transfer byproduct materials. It also specifies the responsibilities of general licensees regard,ing the use of byproduct materials. Under the proposed revisionsanewparagraph(c)(ll)wouidbeaddedtorequirethegeneral licensee to provide specific information to the NRC upon request. This information would include the complete name and address; specific information about the device, such as manufacturer, model number, and number of devices; name, titic, and telephone number of the person responsible for controlling the use of the device; the address where the device is located or used; and whether the specific requirements of paragraph (c) of 5 31.5 have been met, in addition, a proposed revision to paragraph (b) of 6 31.5 would delete all references to specific licenses issu'ed by Agreement States that authorize distribution of devices to persons gener' ally licensed by Agreement States.

The registration and verification system contained in the proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees, including those who previously acquired radioactive sources. If older sources 7

are transferred, they would be subject to the same requirements as newer sources and the registration system is intended to capture them. General licensee transfers of sources are limited to either transfer to specific licensees or other general licensees by the existing provisions of 10 Cfx "-

31.5(c) (8) and (9). In both cases, licensees must notify the NRC of the transfers. If the specific licensee is a 10 CFR Part 32 or Agreement State equivalent distributor, the reporting requirements of the proposed rule would apply to any subsequent transfers., The current NRC data base, although limited, includes identification of general licensees who acquired gauges as early as 1959. The NRC staff plans to contact these licensees and any new general licensee as part of the enhanced oversight effort.

At present,4 10 CFR 31.6, ' General license to install devices generally licensed in 6 31.5," provides a general license to certain specific licensees from Agreement States to install or service devices used under i 31.5. The current regulation,10 CFR 31.6, is not clear with respect to the restrictions. 10 CFR 150.20(b)(3), imposes a 180-day-per-calendar-year limitation on the activities of Agreement State Licensees in non-Agreement States. The proposed amendments to i 31.6 would remove this restriction for i 31.5 licenscos. This change will be convenient to the NRC, Agreement States, and manufacturers because it will reduce and simplify paper work without increasing the risk to public health and safety. The proposed 5 31.6 (a) would require the general licen'see holding a specific license from an Agreement State to report to the NRC all persons receiving a device from the licensee, as specified in the accompanying proposed revision to i 32.52.

Proposed i 31.6 (d) would require the licensee to supply each of the 8

l J

l recipients of a generally licensed device a copy of the general license  ;

contained in i 31.5. Proposed i 31.6 (e) would require that written instruc- l 4 tions and precautions be provided to persons servicing a generally licensed '

i device. Proposed i 31.6 (f) would also require a personyin Ton.llow routine  :

installation / servicing / relocation of these devices to notify the appropriate r

NRC regional office at least 3 working days prior-to the start of the t

. - activities. -This notification would allow for a level of periodic inspection of those activities that intentionally place a worker in direct coritact with

. t the device or an unshielded radiation source. It is not intended that the l prior notification requirement apply in cases where a radiological hazard due to an accident or a malfunction of the device exists. To be consistent with the proposed modifications, the section heading would be amended to read  :

e

" General license to distribute, install, and service devices generally c licensed in i 31.5."

10 CFR 32.51a, "Same: Conditions of licenses," prer'ntly imposes

. conditions on applicants for a specific license to manufacture or initially transfer generally licensed devices to general licensees. The addition of proposed paragraph (c) to i 32.51a would require such specific licensees to provide recipient users of generally l'icensed devices with written 4

instructions and precautions to ensure that the devices are used safely. In addition - these specific licensees would be required to provide those users

~

with Information regarding testing requi'rements, transfer and reporting requirements, and disposal options for the devices being transferred.

10 CFR 32.52, " Material-transfer reports a'nd records," currently requires -

specific licensees authorized to distribute devices to general licensees to i

{

4

_.. _ . . .-. ._a. _.. __ _ _ , ~ , . . .. . . - . . - _ _.__- _ ._.._. _._, _ _ .

fils transfer reports with the NRC on a qdarterly basis. The revised regulation would prescribe the format to be used when submitting transfer reports to the NRC. _The proposed format would provide more detailed and complete information about the genera) lic.%. to $;.us the device is transferred. The format is presented in proposed Subpart E, 6 32.310.

Licensees who do not use the prescribed format would be permitted to provide all of the information required by the format on a clear and legible record.'

In addition, spec 8fic licensees would be required to identify a person responsible for meeting the requirements associated with the possesston of the generally licensed device rather than simply identifying a point of contact at the general licensee's location, After recei,pt of the quarterly transfer reports from the specific licensee under i 32.52, the NRC would send letters to the general Itcensees who received the devices during the preceding reporting period requesting them to' verify in writing that they had purchased the devices containing byproduct material and that they understand the requirements of the general license.

The general Itcensee under proposed i 31.5(c)(11)(ti) would be required to respond to the NRC by letter and to verify safety-related information'about the device and its location.. Thereafter, notices would be sent periodically

- to the general licensees requesting that they verify that they still have the device. verify the safety-related information,- and remind them of their regulatoryresponsibilitiesinusingth(device. The frequency of these letters may range from 1 to 3-years. Any failure to respond or any reports of lost' devices would initiate NRCl follow-up action. This contact between the NRC-and. the general licensee would allow the NRC to validate-and update the 10

l info;mation currW!y contained in the data base that the NRC maintains for its general licensees.

Although these proposed requirements would impose additional costs on licensees, the Comission has ediindet these to be nominal (on the order of

$10 per device). Accordingly, the Comission believes that the increased compliance by general licensees and confidence in the appropriateness of the &

ganeral license program potentially. afforded by these new requirements outweigh this cost. Nonetheless, the Comission particularly requdsts '

coments on this matter.

At the time of the final rulemaking on this matter, the Commission intends to provide for an interim enforcement policy to supplement tau current Enforcement Fol{cy in 10 CFR Part 2, Appendix C, to address violations arising from the proposed regulations. The interim policy would remain in effect for one cycle of the notice and response program, approximately three years.

Under the existing NRC Enforcement Policy, significant violations such as those involving lost sources may result in escalateu action including civil penalties. The interim policy would provide that in the initial phase of the implementation of a notice and response pr ? ram, enforcement action would not normally be taken for violations identified by a licensee in submitting information pursuant to the proposed regulation provided appropriate corrective action is initiated. This change from the Commission's normal enforcementpolicyin10CFRPart2,ApdendixC,istoremoveanydisincentive to identify deficiencies caused by a concern of potentihi enforcement action.

This action would tie taken to encourage general licensees to search their facilities to assure sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective action when 11

deficiencies are found. However, enforcement action will be considered for -

violations involving the failure to provide the information requested or take appropriate corrective actions or willful violations including the submittal of false infuruiauerii. ' Sanctions in those situations may include civil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a general license.

Environmental Impact: Categorical Exc'inston The NRC has determined that the proposed regulations are the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii).

Therefore, neitger an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.

Paperwork Reduction Act Statement The proposed rule amends the information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This proposed rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.

The public reporting burden for this collection of information is estimated to average about 20 minutes pdr response, including time for reviewing instructions, searching existing data sources, pthering and maintaining the data needed, and completing ar.d reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this 12 ,

burden, to the Information and Records Management Branch (MNBB-7714), U.S. -

Nuclear Regulatory Commission, Washington, DC 20555, and to _ the Desk Officer, Office of Information and Regulatory Affairs, NE08-3019, (3150-0016 and 3150-

- OC01), Office of Management and Budget, Washington, DC 20503, Regulatory Analysis The NRC has prepared a draft regulatory analysis of this proposed ,

regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

Single copies of the draft analysis may be obtained from Joseph J. Mate, a

Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: 301-492-3795.

Regulatory Flexibility Certification Based on information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic-impact on a substantial number of small entities. The NRC has adopted size standards that classify a s' mall entity as one whose gross annual receipts do not exceed $3.5 million over a 3-year period. The proposed rule affects about 35,000 persons using products under this general license, many of whom would be classified as a small entity. However, the NRC believes that the economic impact of the proposed requirements on any general licensee would 13 w

be negligible. The proposed rule is being issued to better ensure that the general licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.-

Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to these proposed rules and therefore a backfi,t analysis is not required because these proposed amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).

, List of Subjects in 10 CFR Parts 31 and 32 10 CFR Part 31 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipnent.

10 CFR Part 32- ,

Byproduct material, Criminal penalties,-Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment. i 14

. --. -o,- .-- m v

l 1

.e.

1 For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 31 and 32.

PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

1. The authority citation for Part 31 is revised to read as follows:

' Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842).

Section 31 6 also issued under sec. 274, 73 Stat 688 (42 U.S.C. 2021).

4 For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);

553!.5 (c)(1)-(3) and (5)-(9), 31.6, 31.8(c), 31.10(b), and 31.ll(b), (c),

and id) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C.

2201(b); and I!31.5 (c)(4), (5), (8), and (11), 31.6 (d)-(f), and 31.ll(b) and (e) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C.

2201(o)).

2. Section 31.2 is revised to read as follows:

6 31.2 Terms and conditions.

The-general licenses provided in th'is part are subject to the provision ,

of El 30.9, 30.14(d), 30.34(a) to (e), 30.41, 30.51 to 30.63, and Parts 19, 4

15 w

20, and 21 of this chapter' unless indicated otherwise in the language of the general license.

3. In i 31.4 paragraph (b) is revised to read as follows:

i 31.4 Information collection requirements: OMB approval.

t (b) The approved information collection requirements contained in this part, appear in il 31.5, 31.6, 31.8, and 31.11. .

4. In i 31.5, paragraph (b) is revised and paragraph (c)(11) is added to read as follgws:

5 31.5 Certain measuring, gauging, or controlling devices.'

(b) The general license in paragraph (a) of this section applies only to byproduct material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to i 32.51 of this chapter or in accordance with the specifications contained in the general license of 5 31.6.

4 (c)

' Attention is directed particularly to the provisions of the regulations in Part 20 of this chapter that relate to the labeling of containers.

' Persons possessing byprnduct material in devices under a general license in i 31.5 before January 15, 1975, may continue to possess, use, or transfer that material in accordance with the labeling requiremente of 5 31.5 in effect on January 14, 1975.

16 r

_ (11) Shall respond within 30 calendar days of receipt of a request from .

- the Nuclear Regulatory Commission to-verify the following information and any -

other such information as may be requested by the Commission as it-relates to-the general license. Further, the general licensee shall notify the Director ,

of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington D.C. 20555 within 30 calendar days if any of the requested

.-information should change.

(1)- Name and complete address- of the general licensee.

(ii) Identification of specific information about the device, such as:

the manufacturer, model number,'the number of devices, type of isotope, and who has performed what service on the device since the last report concerning thedevicewasgubmittedto'heNRC.

~

(iii) Name, title, and telephone number of the person who is responsible

- for. the device and for ensuring compliance with the appropriate regulations and requirements.-

(iv) Address at which the device is-located or used.

(v) Whether the requirements of i 31.5(c)(1) through (c)(10) have been met.

l *- * *. * *

5. 'Section 31.6 is amended by revising the section heading and the introductory paragraph and by adding par'agraphs (a), (d), (e), and (f) to read 4

as follows:

i 31.6 General license to distribute, install, and service devices generally licensed in 5 31.5.

i 17

, --.,,,,A

Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, distribute, install, or service devices described in i 31.5 within the Agreement State is hereby granted a general

, license to distribute, install, or service the devices in any non-Agreement -

State for an unlimited period of time and a general license to distribute, install, or service the devices in offshore waters, as defined in i 150.3(f),

provided that:

(a) The Agreement State licensee files the_ appropriate transfer reports as required by paragraphs (a) and (b) of i 32.52.

(d) The person shall furnish a copy of the general license contained in i 31.5 of this cpapter to each person who is responsible for the byproduct material and for ensuring compliance with the appropriate regulations and requirements.

(e) -The person shall provide the individual responsible for service of the device with written instructions and precautions necessary to ensure its safe installation, operation, and service. These instructions shall include leak-testing requirements, transfer and reporting requirements, disposal options, including possible costs and reporting requirements for lost or damaged devices.

(f) The person performing routine service / installation or relocation of i devices shall notify the appropriate NRd Regional Office listed in Appendix 0 of Part 20 of this chapter at least 3 working days prior to engaging in such activities in Non-Agreement States. The notification shall include the date l

and location of the activity that will be performed. Prior notification does 1

18

?

! . .i 4

. - not: apply 1in casesLwhere a radiological hazard due to an. accident or-malfunction lof the device' exists.

2

~ ~ ~- '

PART 32 - SPECIFIC DONESTIC LICENSES TO MANUFACTURE OR TRANSFER CE..'AIN ITEMS CONTAINING 8YPR000CT MATERIAL

6. The authority citation for.Part-32 continues to read as follows:

Authority: Secs. 81,;161,182,183, 68 Stat. 935, 948, 953, 9'54,: 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);

l Il 32.13, 32.15 ,(a), (c), and (d), 32.19, 32.25 (a) and (b), 32.29 (a) and (b), 32.54, 32.55 (a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are-issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201-(b)); and il 32.12, 32.16, 32.20,132.25(c), 32.29(c), 32.51a, 32.52, 32.56, and-32.210 are issued under sec.-1610,;68 Stat. 950, as amended (42 U.S.C. 2201(o)).

[

7,- Section 32.51a is amended by adding paragraph-(c) to read as follows:

i 32.51a Same:- Conditions of licenses.

(c) Furnish 'the individuals identified under i 31.5(c)(11) or 131.6(d)_

withwritten:instructionsandprecautiodsnecessary-to-ensuresafe-installation, operation, and service of the device. These instructions must 1nclude:the leak-testing requirements, transfer and reporting- requireme'nts, i.

+

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disposal options including possible costs, and reporting requirements for_ lost or damaged devices.

8. Section 32.52 is revised to read as follows:

1 32.52 Same: Material transfer reports and records.

Each person licensed under i 32.51 or i 31.6 to initially transfer devices to generally licensed persons shall:

(a) Report quarterly to the Director of the Office of Nucleai Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, and send a copy of the report to the appropriate NRC regional office listed in Appendix D of Part 20 of this chapter all transfers of such devices to persons for u,se under the general license in i 31.5 of this chapter. The report must be provided either in the format presented in Subpart E, 6 32.310. " Transfer Report Format," or on a clear and legible record as long as all of the data required by the format is included. If one or more inter-mediate persons temporarily possesses the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediary as in Subpart E, 6 32.310, and clearly designate that person as an intermediary. If no transfers have been made to persons generally licensed under i 31.5 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of the end of th'e calendar quarter.

(b) Report quarterly to the responsible Agreement State agency all trarisiers of such devices to persons for use under a general' license in an Agreement State's regulations that are equivalent to i 31.5. The report must 20

be provided either in the format in Subpart E, 6 32.310, " Transfer Report Format," or on a clear and legible record as long as all of the data required by the format is included. If one or more intermediate persons temporarily possesses the device at the intended place of use prior toits pos"ssssion by the user, the report must include the same information for each intermediary as in Subpart E, 6 32.310, and clearly designate that person as an

, intermediary. If no transfers have been made to persons generally licensed

-under i 31.5 during the reporting period, the, report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter.

(c) Keep records of all transfers of such devices for each general licensee and in. compliance with the above reporting requirements of 6 32.52.

Records required by this section must be maintained for a period of 5 years from the date of the recorded event.

9. Subpart E, Section 32.310 is added to 10 CFR Part 32 to read as follows: -

Subpart E - Report of Transfer of Byproduct Materials 1 32.310 Transfer Report Format.

This section contains the format required by 6 32.52.

21

Subpart E-Report of Transfer of Byproduct Materials Sectio.n 32.310 - Transfer Repos i Furfoot .

NAME OF VENDOR AND LIC$NSE NUMBER REPORTING PERIOD

. FROM TO GENERAL LICENSEE INFORMATION - <

COMPANY NAMd, STREET, CITY, DEPARTM ENT.

STATE, ZIP CODE IERSON RESPONSIBLE FOR' CONTROL OF THE DEVICE MAME AND TITLE TELEPHONE NUMBER FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY AND UNITS NUMBER NUMBER 4

+-

-____m __ ____.-_ _ _ _ _ _ . - _ _ _ e'-

P

Subject:

Requirements for the Possession of Industrial Devices Centaining Byproduct Material (RIN 3150-AD34).

Dated at Rockville, Maryland this /,2 day of Is 1991.

For the Nuclear Regulatory Comission.

, / .

• \ T/ ~

6/M.Taylo/

E ecutive Director for Operations 4

4 4

23

. . - . . . .- . . - . - - . - . . . . - . . . . _ . . - . .~_

+

Subject:

Requirements for the Possession of Industrial Devices Containing Byproduct Material (RIN 3150-AD34).

Dated at Rockville, Maryland this. /A day of h $ u s1991.

For the Nuclear Regulatory Commission.

Original Signed 89 .,

James M. Taylor ,

James M. Taylor Executive Director for Operations G

. EDO JTaylor 12/ /91 23

_ _ _ _ ___ _ _ _ _ _ . __ ,e , ,

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0 ATTACHMENT 2 4

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. 'o UNITED STATES

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E NUCLEAR REGULATORY COMMISSION W ASW No T ON, D. C. 20555

,o The Honorable Peter H. Kostmayer, Chairman Subcommittee on Energy and the Environment em=rittee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515

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 Reaister. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is pro)osing to amend these regulations to require the general licensees to provide tie NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material.

Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience 4The general licensee is required to comply with the safety instructions provided and to have all servicing done by persons with appropriate experience who are licensed to perform the service. In order to evaluate the effectiveness of the general license program, we have conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Through these actions, the NRC will be able to provide greater assurance that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Notice of Proposed Rulemaking cc: The lionorable John J. Rhodes

e a aseg'o

,. UNITED STATES f(p p, NUCLEAR REGULATORY COMMISSION ,

y, t WAsmNGTON, D. C. 20555

%,....) .

The Honorable Bob Graham, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510 Ocar Mr. Chairman:

Enclosed for the information of the subcommittee.is a copy of a Notice of Proposed Rulemaking to be published'in the Federal Reoister.- 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is proposing to amend these regulations to require the general licensees to provide the NRC with specific information about the licensed devices. Corresponding changes would also be made in 30 CFR Part 32 on the transfer reporting-requirements imposed on persons authorized to distribute byproduct material.

Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience. 4The general < licensee is required to comply with the safety instructions provided and to have all servicing done by persons with appropriate experience who are licensed to perform.the service. In order to evaluate the effectiveness of the general license program, we have conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate -

accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Through these actions, the NRC will be able to provide greater assurance that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiation exposure to'the public.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Notice of Proposed Rulemaking cc: The Honorable Alan K.-Simpson

/ 'o UNIT ED STATES y" ~,,

p, NUCLEAR REGULATORY COMMISSION g

l W A$mNGTON, D. C. 20$$5 jf

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The Honorable Philip R. Sharp, Chairman Subcommittee on Energy and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Eg@r_Al Reaister. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is proposing to amend these regulations to require the general licensees to provide the NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material.

Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience. 4The general licensee is required to comply with the safety instructions provided and to have all servicing done by persons with appropriate experience who are licensed to perform the service. In order to evaluate the effectiveness of the general license program, we have conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Through these actions, the NRC will be able to provide greater assurance that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Notice of Proposed Rulemaking cc: The Honorable Carlos J. Moorhead

34 '

4 e

ATTACHMENT 3 6

4

h

. Acijpn: Beckjord,-RES

_/#. . u y%, UNITED $TATES CyS: laylor -

f' n NUCLEAR REGULATORY COMMISSION . S niezek 2,, -- :i W ASHIN GT ON, D.C. 2055s Thompson

/ Blaha g%r* - ****

/

• November 29, 1991 Bernero, NMSS Lieberman, OE OFFICE OF THE- Kamerer, SP

• stentTAny Mate, RES

'Scroggins, 0C Meyer, ADM _

Shelton -IRM HEMORANDUM FOR: James M. Taylor

. Executive Director for eTations PROM: Samuel J. Chilk, Secret

SUBJECT:

- SECY-91-275 - PROPOSED E[DMENTS TO 10 CFR PART 31, " GENERAL DOMES CJ LICENSES FOR BYPRODUCT MATERIAL," AN 10 CFR PART 32,

" SPECIFIC DOMESfIC LICENSES TO, MANUFACTURE OR TRANSFER CERTAIN. ITEMS CONTAINING BYPRODUCT

-MATERIAL" The Commission (with all Commissioners agreeing) has approved issuance of.the proposed amendments to 10 CFR Parts 31 and 32 as ,

a proposed rule subject to the changes in.the attachment.

-fEDO). (RES) (SECY Suspense: 12/20/91) 8900090 The-following comments are providel:

_1) The discussion of Agreament State licensees and regulatory programs'in the Statements of Consideration should be amplified to reflect the staff' responses to several of Commissioner Curtiss' questions. See the insert on page 5 of the notice.

2) The regulatory framework and applicau..Lity to older sources should be added the. Statements of Consideration consistent with the staff responses _to Commissioner Curtiss'-questions 5 and 6. See tha. insert on page:7 of the notice.

1. On page 6, the discussion of potential changes to the scope

_3)

.of' general-licensed devices should be' deleted. Mentioning the possibility of future such changes is not relevant to these amendments at thisztime and the proposed language would_likely cause confusion.

U 4)-- The lettera to Congress should be-modified as shown in-the attachments-to be more consistent with the summary and background sections of the notice.

'SECY NOTE: THIS SRM, SECY-91-275, AND THE VOTE SHEETS OF THE CHAIRMAN, AND COMMISSIONERS: ROGERS _AND CURTISS WILL DE MADE PUBLICLY AVAILABLE 10 WORKING DAYS FROM THE DATE OF THIS SRM 4 .

<-r-- , , - -, ,v.,-m- - - . - . ~ , . - - - - - _ _ - - - - - .

. ._ _ .m. _ .. _ . . _ _ _-_ .. . _ _ ~ - _ . - _ _ . . - - _ . _ . . _ . . _ _ --_ _ _ _. .

.6 2 --

- 5) .The staff response to Commissioner Curtiss' questions 8 and

'9 indicate that no special monitoring or inspection of how well manufacturers'and distributors may be complyi6g with the new reporting requirements is anticipated. He plans to revisit the compliance issue when the final rule is ~

submitted for Commission approval.

4

Attachment:

As stated.

t

'~

cc: .The Chairman-

,. Commissioner-Rogers .

Commissioner Curtiss Commissioner Remick OGC

-OIG e

j 2

. 4 0 m

_._________J__.___._ . . , . ,. _ , , , , _ . . . . , _ . . . . . _ ,

storage of devices in warehouses, disposal in scrap yards, incineration of waste, melting in a smelter, and disposal in a landfill. Included'in the risk assessment was an incident at a steel company in 1983 (discussed in NUREG- , , ,

1188, "The Auburn Steel Company _ Radioactive Contamination Incident") that probably represents a worst-case scenario for generally licensed gauging devices. Although individual doses were low and within aforementioned limits for exposure of members of the public, they nevertheless represent' unnecessary additional public exposure that could have been avoided. In. addition, the cleanup costs were in excess of four million dollars with additional costs incurred for the staff efforts of regulatory agencies.

In consideration of both the risk assessment and incidents like those noted above, thehNRC conducted a three-year sampling (1984 thru 1986) of general licensees (taken from the vendors' quarterly reports) to determine whether there was an accounting problem with gauge users under general licenses, and if so, what remedial action might be necessary. The sampling was conducted both by telephone calls and site visits. The sampling revealed several areas of concern about the use of radioactive material under the general license provisions. On the basis of the sampling, the NRC concluded that there is (1) a lack of awareness of appropriate regulations on the part of the user (general licensee) and (2) inadequate handling and accounting for these generally licensed devices. The NRC further concluded that these two problems could be remedied by more frequent and timely contact between the general licensee and the NRC. This conclusion by the NRC provi. des the basis for the. regulatory changes proposed in this action ule would D Th a Q

fma m atibiljty'for reement St es. The Agreem tates t

L_pa:Licipi ed in the deve upment_.ofd s rule.

les o the proposed le g A 5 Enclosure

Insert A, page 5 ,

An estimated 70,000. Agreement State licensees use the types of sources and devices covered by the amendments being proposed today for NRC's general licensees. Consequently, the States will play an important role in achieving improved regulatory oversight on a national basis. Many of the States already have accountability programs in place. The Agreement States ~ ~

participated in the development of this rule and indicated agreement with the concept of the proposed rule. Specific comments from the Agreement States were adopted except for suggestions that NRC charge general licensees fees and that there is no need for a standard format for submitting information. The fee issue will be addressed separately. The proposed rule provides flexibility in the use of the standard format.",

The commission is considering making the amendmente a matter of compatibility for the States. NRC staff has suggested that the amendments be categorized as Division 2 level of compatibility.

This level of compatibility requires that States address provisions in NRC regulations relating to basic principles of radiation safety and regulatory functions without necessarily using identical language. States may also adopt requirements more restrictive than NRC rules under this level of compatibilityk The NRC would appreciate comments on this suggestion.

S w

-l h

,. _ _ - -_ t were circulated to the Agreement States. They have supported the rulemaking and all their comments were considered and incorporated as appr 'riate.

- The ris ssessment and the sampling above also led the mmission to Q conclude that for small group (a few hundred) of gener y licensed gamma gauges the radiation r , though'small in an absolu sense, may be a

sufficient to warrant'their nyersion to specif In addition, licenses.

there also appears to be anothe , larger gr p of generally licensed devices (about 10,000) where the radiation r s estimated to be.very low. These devices, e.g.,- beta backscatter ga es an nalytical devices may be I

candidates for exemption from rther regulatio under the Commission's BRC Policy. The Commission i considering these action This proposed

-regulation addretses e vast ma.fority of generally lice ed devices that fall 4

in the middle of .e risk spectrum. For these dovices, the r k is small to 4

the extent t t specific licensing can not be justified. But nett is it so small, ecially in consideration of the very large numbers of such devices }

(ext t, that exemptions would appear to be appropriate. f An estimated 35,000 persons use certain measuring, gauging, or

. MC 's

_ f V

controllingdevices-underpgenerallicense. NRC= regulations that affect these general licensees' responsibilities and that are presently being amended are 10 CFR 31.2, 31.4, 31.5, and 31.6. Under 10 CFR 31.2, " Terms and

' Conditions," all general licensees are subject to certain provisions of Part 30 and-also Parts 19, 20, and.21. The proposed revision to 5 31.2 would also

- subject all- general- licensees to -the requirements of 10 CFR 30.9,

" Completeness and Accuracy of:Information," which imposes certain requirements regarding the completeness and accuracy of the information submitted to NRC by licensees not now imposed upon general licensees.

6 Enclosure

- - v'- -

. . .- - - . - . - . .- - - . . ~_- . - --- --

i Section 31.4 of 10 CFR P' art-31 "Information Collection Requirements:

E 0M8 approval," lists .th various sections of Part 31 that contain approved information collection:. requirements. Paragraph b of 5 31.4 is being amended to add 5 31.6 to the approved listing. . ,

e Section 31.5, "Certain measuring, gauging or controlling devices,"

provides-for a general licensee ^ to acquire, receive, possess, use, or transfer s . byproduct materials. It also specifies the responsibilities of general

licensees regarding the use of byproduct materials. Under th,e proposed revisions a new paragraph (c)(11) would be added to require the general licensee to provide specific information to:the NRC upon request. This  ;

information would include the complete name and address; specific information  :

about -the device,- such as manufacturer, model number, and number of devices; name,-title, and telephone number of the person responsible for controlling e -the use.of the device; the address where the device is located or used; and whether the specific requirements of paragraph (c) of 5 31.5 have been met.

-In -addition, a proposed revision to paragraph (b) of 5 31.5 would delete all references to specific licenses issued by Agreement States that authorize distribution of devices to persons generally licensed by Agreement States.

MT,'At g_ present,10 CFR 31.6, " General . license to install . devices generally licensed in 5 31.5," provides a general-license-to certain specific licensees from Agreement States to-install or service devices used under 5 31.5. The current regulation, 10 CFR 31.6, is not clear with respect to time restrictions. ' Paragraph 150.20 (b)(3) of 10 CFR Part 150 imposes a 180-day-1per-calendar-year limitation on the: activities of Agreement State Licensees in

.non-Agreement States.~ The proposed amendments to 5 31.6 would remove this

~

restriction for. 5 31.5 licensees. This change will be convenient to the NRC-7 Enclosure

• r,.. - -,r , - . , ,

Insert B,-page 7 ,

The registration and verification system contained in the proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees, including those who previously acquired radioactive sources. If older sources are-transferred, they would be subject to the same requirements as newer sources and the registration system is intended to capture them. General licensee transfers of sources are limited to either transfer to specific licensees or other general licensees by the existing provisions of 10 CFR 31.5(c) (8) and (9). In both cases, licensees must notify NRC of the transfers. If the specific licensee is a 10 CFR Part 32 or Agreement State equivalent distributor, the reporting requirements of the proposed rule would apply to any subsequent transfers. The current NRC data base, although limited, includes identification of general licensees who acquired gauges as early as 1959. NRC staff plans to contact these licensees and any new general lice'nsee as part-of the enhanced oversight effort.

e e

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, ' /g>h 80 0 jq'o

< UNITED STATES

!4- 'I NUCLEAR REGULATORY COMMISSION

[- .I W AStUNGTON, D. C. 20$55

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The Honorable Bob Graham, Chairman -

Subcommittee on Nuclear Regulation Committee on Environment and Put,lic 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 publishad in the Federal Register. 10 CFR Part 31 establishes general licenses for the possession and use of 6yproduct material contained in certain devices. The NRC is proposing to amend these regulations to require the general licensees to provide the NRC with specific information

, about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material.JThese ch ng are being made because th is7 in quate account 1 T generally 1 ensed ices, and also a al lack i of aw ss o6 e approp ' te re ations on the rt of ral licensees.

It isp cipate the y pose s will e e tha ese two problems (are (cmedied by more t eFy contact- between Att general license andtheNRC.)

hsERT C. Sincerely, ON N'

3. 2 3 4'esS.

Eri Beckjbd lirector Officisof Nuclea'r, egulatory Resea xch

Enclosure:

DE K.  % Ech R Notice of Proposed Rulemaking o t' r i t 4 op e c m M e,3y, o n q g yo;

-cc: Senator Alan K. Simpson gY 'a, k 5% \

9 9 m

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Insert C, Congressional Letter, Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience. The general licensee is required to comply with the safety instructions provided'and to have all servicing done by persons with appropriate experience who arc licensed to perform the service. In order to evaluate the effectiveness of the general license program, we have - -

conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is-inadequate accounting for the devices and a ,

lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Through these actions, NRC will be able to provida greater assurance that generally licensed devices are properly handled a'nd disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

4 O e

in .

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4

. ATTAtilKT.NT 4 a

v b

+

i material. This awareness will better assure that general licensees will comply with the requirements for proper handling and disposal of generally licensed devices and presumably reduce the potential for incidents that could result in unnecessary radiation exposure to the put,1h..~ -

DATE: The comment period expires 75 days after publication. Comments received after this date will be considered if it is practicable to do so, but the NRC is able to ensure consideration only for comments received 'on or before this date.

ADDRESSES: Mail written comments to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.

4 Ocliver comments to One White Flint North,11555 Rockville Pike, Rockville, MD, between 7:30 am and 4:15 pm on weekdays. Copies of the draft regulatory analysis, as well as copies of the comments received on the proposed rule, may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower Level),

Washington, DC.

FOR FURill[R INFORMATION CONTACT: Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3795.

2 Enclosure

3

. M hS711g Mggggp -

i (7590-01)

J/ /

-FEDERA1.-RMMTER-HOTM+-

I NUCLEAR REC'Al.TC3'h t0:1MISS10N 10 CFR Parts 31 and 32 RIN 3150 - A034 4

f Requirement j for the Possession of Industrial /

Devices Containing Byproduct Material 4

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing' the safe use of byproduct material in certain measuring, 1 gauging, or controlling devices. The proposed changes, among other things,

~

would rtiquire general licensees who possess these devices to provide the NRC information about the identification of devices and the people responsible for spe'i tW Uccett tes W ut y

'the devices. Further gdistributors of generally licensed devices under 10 CFR-

~V 1.5 (sge'hfihlNen'wh4 would be required to use a uniform format when submitting the-quarterly transfer reports to NRC. The proposed rule is intended to ensur,e that general licensees are aware of and understand the' requirementsCAttendantt he possession of devices containing byproduct V ,

1-

'm

/ Enclosure 4 .2 %

x m . _ ... #

i i

i i

$UPPLEMENTARY INFORMATION:  !

l' Background-f On' February 12,1959.(24FR1089),theAtomicEnergyCommissionamended its regulations to provide a general license for the use of byproduct material l 1

contained in certain luminous, meauring, gauging, and controlling devices.

oW aes

Under the currentGoncTT.io% g ptsushw ofnm for a general license, certain / person  ;

receive and use a device containing byproduct material if the device has been manufactured and distributed in accordance with the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific puso y license is issued upon a determination by a regulatory authority that the a3 safety features of the device and the instructions for safe operation are adequate and meet regulatory requirements. The general licensee is required )

to comply with the safety instructions contained in or referenced on the label of the device and to have the testing or servicing of_the device performed by.

an individua! authorized to manufacture, install, or service these devices. A l 4

generally-licensed device is a " black box." that.is, the radioactive material is contained in a sealed source usually within a shielded device. The device l

is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. Thus,the general license V 4

policy is a mechanism.to simplify the lic'ensc process so that a case-by-case -i determination of the adequacy of the radiation training or experience _of each user is not necessary.

-I 3 Enclosure ,

- ,.3 ,. ..,,.L.,,:,,... . . + ...-m. . ,.._.,..,.,m ~ - . . - . ,

Discussion -

There are about 600,000 devices contain yproduct material in use by Y about 30,0001kt.. sees under the Commission's general license regulatory program. General licensees have not been contacted by NRC on a regular basis because of the relatively small radiation risk posed by generally licensed devices. These devices have survived fires and explosions on many occasions without a total loss of shielding. They have been damaged by molte'n steel, and hit by construction vehicles with only minor losses in radiation shielding while maintaining the integrity of the source capsule. 3 cmm g ; g c.

Nonetheless, there have been a number of occurrences where radioactive 4

et wo g V

material $as not been properly handled or disposed3c,f resultt[on radiation 4

exposure of the public. Although no significant public health and safety hazards resulted from these incidents, proper handling and disposal #

procedure # bs been followed, these avoidable exposures would not have occurred. V for example, one or more cesium-type gauges were mixed in with some scrap metal that was melted down to form steel and the entire batch of steel was contaminated. in another instance, a static eliminator bar with 22.5 rii111 curies of americium-241 was sent to a sanitary landfill over which the NRC has no jurisdiction. There have been other types of incidents involving NRC generally licensed devices including damaged devices, leaking or contaminated sources, and equipment malfunctions. However, loss of accountability, as occurred above, remains the most frequent incident and the predominant concern.

Because of these occurrences, the NRC's Office of Nuclear Material Safety and Safeguards (NMSS) conducted a radiological risk assessment addressing 4 Enclosure

i

.. l

.* r storage of devices in warehouses, disposal in scrap yards, incineration of p ss

. waste . melting in a smelter, and disposal in a landfill. geluded in the risk Y l l assessment h n incident at a steel company in 1983 (discussed in NUREG- #  !

-1100, "The Auburn Steel Company Radioactive Contamination Incident") that' ,

probably represents a worst-case scenario for genertily licensed gauging I tstsc 6 t t o u V

devices. Although -individual- doses were low and within6forementioned)11mits- .

for exposure of members of the public, they nevertheless represent unnecessary additional. public exposure that could have been avoided, in addition, the i

cleanup costs were in excess of four million dollars with additional costs incurred for the staff efforts of regulatory agencies.

In consideration of both the risk assessment and incidents like those noted above. the NRC conducted a three-year sampling (1984 thru 1986) of

- i 4

general licensees (taken from the vendors' quarterly reports) to determine  ;

whether there was an accounting problem with gauge users under general licenses, and if so, what remedial action might be necessary. The sampling was conducted both by telephone calls and site visits. The sampling revealed

. gGain ee several areas of concernMhe use of radioactive material under the #

_ general license provisions. On the basis of the sampling, the NRC concluded nu s -

, -that there'is ,(1) a lack of awareness of appropriate regulations on the part of the user (general licensee) and-(2) inadequate handling and accounting.for these generally licensed devices. -The NRC further concluded that these two problems could be remedied by more frequent ~ and timely contact between the general ~ licensee and the NRC. This conclusion by the NRC provides the basis I

-fortheregulatorychangesproposedinthisaction[Ther e would be a Ia ter of compa 111ty for the reement States. The Agreemen tates.

partic ated in the velopment of_t s rule. Copie of the propose. ule

. s n ti RN3 E R T A 5 Enclosure  :

i

_ _ - -- . ..- .. . . - , . - .- _ _ _ _ a-u._ _ __.. _ _ ,,_ _ _ _ _ . . -

_ ~ . _- _ - - - . - - - ._- - . . - . . . . . - . . - . - - _ _ - _ . - .

l l

Insert A, page 5 ,

An estimated 70,000 Agreement State licensees use the types of sources a <j devices covered by the amendments being proposed '#

today to TRC's general licensees. Consequently, the Sthtes will play an important role in achieving improved regulatory oversight on a national basis. Many of the States already have accountability programs in place. The Agreement States participated in the development of this rule and indicated agreement with the concept of the proposed rule. Specific comments from th greement States were adopted except for b' suggestions that C charge general licensees-tees and that there is no need for a standard format for submitting information. The fee issue will be addressed separately. The proposed rule

.provides flexibility in the use of the standard format.",

The Commission is considering gking the amendmentg a matter of compatibility for the States. NRC staff has suggested that the L' amendments be categorized as vision 2 level of compatibility.

This level of compatibility requires that States uddress provisions in NRC regulations relating to basic principles of radiation safety and regulatory functions without necessarily using identical language. States may also adopt requirements more restrictive The thanNRC'would NRC rules under this level of appreciate comments on this -

. compatibilitf. 5, suggestion. g .

.g I

O h s . . . , . _ _ . . _ - - , , - . , _ . _ ~ , - , . . . , . _ _

l

. I s 3 were circulated to e Agreement States. The have supported the rulemaking

'a d all of their come ts were considered and in rporated as appropriate.

The risk assessment nd the sampling above als led the Comission to conclu e that for a small g up (a few hundred) of gen ally licensed gama gauges t radiation risk, tho h small in an absolute se e, may be sufficient o warrant their conve ion to specific licenses. In addition, there also ap ars to be another, la er group of generally lic nsed devices (about10,000) ere the radiation ris is estimated to be very 1 . These vices, e.g., bet backscatter gauges an analytical devices may be can dates for exemp on from further regul ion under the Comission' BRC Policy. The Comission is considering these a ions. This proposed regulatio addrjssesthe st majority of general licensed devices that f 1 l in the midd of the risk sp trum. For these devic s, the risk is small to the extent tha specific licens g can not be justifie But neither is it so small, especially in consideration of the very large numb s of such devices extant, that exempt ns would appear to be appropriate. I An estimated 35,000 persons use certain measuring, gauging, or

& N RC.'t V controlling devices under A general license. NRC regulations that affect these general licensees' responsibilities and that are presently being amended are 10 CFR 31.2, 31.4, 31.5, and 31.6. Under 10 CFR 31.2, " Terms and Conditions," all general licensees are subject to certain provisions of Part 30 and also Parts 19, 20, and 21. The proposed revision to 5 31.2 would also subject all general licensees to the requirements of 10 CFR 30.9,

" Completeness and Accuracy of Information," which imposes certain requirements he.

regarding the completeness and accuracy of the information submitted to NRC by u licensees not now imposed upon general licensees.

6 Enclosure w ,>,_m - - - - , ~ - .

Section 31.4 of 10 CFR Part 31. "Information Collection Requirements: '

OMB approval," lists the various sections of Part 31 that contain approved information collection requirements. Paragraph (b)f531.4isbeingamended /

to add 5 31.6 to the approved listing.

Section 31.5, 'Certain meuuring, cauging or controlling devices,"

provides for a general licensee to acquire, receive, possess, use, or transfer byproduct materials. It also specifies the responsibilities of general licensees regarding the use of byproduct materials. Under the proposed revisions,a new paragraph (c)(ll) would be added to require the general licensee to provide specific information to the NRC upon request. This information would include the complete name and address; specific information about the device, such as manufacturer, model number, and number of devices; e

name, title, r.nd telephone number of the person responsible for controlling the use of the device; the address where the device is located or used; and whether the specific requirements of paragraph (c) of 5 31.5 have been met.

In addition, a proposed revision to paragraph (b) of 5 31.5 would delete all references to specific licenses issued by Agreement States that authorize distribution of devices to persons generally licensed by Agreement Std es. y su 4 r gs tIG B At present, 10 CFR 31.6, " General license to install devices generally-licensed in 5 31.5," provides a general license to certain specific licensees from Agreement States to install or service devices used under 5 31.5. The current regulation, 10 CFR 31.6, is not clear with respect to time wtfR F restrictions, d'aragrapfb 0.20 (b)(i)(of 10 CFR Part 150) imposes a 180-day- V per-calendar-year limitation on the activities of Agieement State Licensees in non-Agreement States. The proposed amendments to S 31.6 would remove this restriction for 5 31.5 licensees. This change will be convenient to the NRC, 7 Enclosure

, . , _ .- y - -_m , , , _ ,

l 0

. \

Insort B, page 7 ,

The registration and verification system contained in the proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees, including those who previously acquired radioactive sources. If older sources are transferred, they would be subject to the same requirements as newcr sources and the registration system is intended to capture them. General licensee transfers of sources are limited to either transfer to specific licensees or other general licensees by the existing-provisions of 10 CFR .5 (c) (8) and (9). In If both cases, the specific licensees must notif C of the transfers.

licensee is a 10 CPR art 32 or Agreement State equivalent distributor, the reporting requirements of the proposed rule would apply-to any subsequent transfers. The current NRC data base, although limited, includes identification 94 general 6#

licensees who acquired gauges as early as 1959. lfRC staff plans to contact these licensees and any new general flcensee as part of the enhanced oversight effort.

4 e

N &

Agreement States, and manufacturers because it will reduce and simplify paper work without increasing the risk to public health and safety, oposed M

% rep {31.6 (a) would require the general licensee holding a specific license V from an Agreement State to report to the NRC all persons receiving a device from the licensee, as specified in the accompanying proposed revision to y t us S 32.52. Proposed GaragranfD 31.6 (d) would require hat licensee to supply V 3

each of the recipients of a generally licensed device a copy of the general Proposed Q[a agrand31.6 (e) would require that #

license contained in 5 31.5.

written instructions and precautions be provided to persons servicing a 5v 9 generally licensed device. "

Proposed (Karagrapl 31.6 (f) would also require a person performing routine installation / servicing / relocation of these devices to notify the appropriate NRC regional office at least 3 working days prior to a

the start of the activities. This notification would allow for a level of periodic inspection of those activities that intentionally place a worker in direct contact with the device or an unshielded radiation source. It is not intended that the prior notification requirement apply in cases where a radiological hazard due to an accident or a malfunction of the device exists.

To be consistent with the proposed modifications, the section heading would be amended to read ' General license to distribute, install, and service devices generally licensed in 6 31.5."

sA M '. \/

10 CFR 32.51a, " Conditions of licenses," presently imposes conditions on appilcat for a specific license to manufacture or initially transfer #

generallylicenseddevicestogenerallicensefs. The addition of nroposed paragraph (c) to E 32.51a would require such specific licensees to provide recipient users of generally licensed devices with written instructions and precautions to ensure that the devices are used safely, in addition, thest:

8 Enclosure

< specific licensees would be required to provide those users with information

, regarding testing requirements, transfer and reporting requirements, and disposal options for the devices being transferred.-

10 CFR 32.52, ' Material transfer reports and records," currently requires " - '

specific licensees authorized to distribute devices to general licensees to file transfer reports with the NRC on a quarterly basis. The revised regulation would prescribe the format to be used when submitting transfer

reports to the NRC. Theproposedforma5 ovide more detailed and W complete information about the general licensee to whom the device is transferred. The format is presented in proposed Subpart Egf ."rt M,P 5 32.310. Licensees who do not use the prescribed format would be permitted to provide all of the information required by the format on a clear and legt-4 ble record. In addition, specific licensees would be required to identify a person responsible for meeting the requirements associated with the possession of the generally licensed device rather than simply identifying a point of contact at the general licensee's location.

After receipt of the quarterly transfer reports from the specific licensee under 5 32.52, the NRC would send letters to the general licensees mvuOi* v _

,f whoreceivedthedevicesduringtheprecedingreportingperio{(andasklthemto V verify in writing that they had purchased the devices containing byproduct material-.and that they understand the requirements of the general license.

-The general licensee under proposed 5 31.5(c)(11)(ti) would be required _ to respond to the NRC by letter and to' verify safety-related information about the device ~'and its location.: Thereafter, notices would be'sent' periodically to the general . licensees requesting that they-verify that-they still have the device, _ verify.the safety-related information, and remind-them of their z _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ 9 : __ __ _

__ __ ;_ Enclosure 2

i e

regulatory responsibilities in using the device. The frequency of these letters may range from 1 to 3 years, Any failure to respond or any reports of lost devices would initiate NRC follow-up action. This contact between the NRC and the general licensee would allow the NRC to validate and updh e the information currently contained in the data base that the NRC maintains for its general licensees.

Although these proposed requirements would impose additional costs on licensees, the Comission has estimated these to be nominal (on the' order of

$10 per device). Accordingly, the Comission believes that the increased compliance by general licensees and confidence in the appropriateness of the general license program potentially afforded by these new requirements outweigh this cost. Nonetheless, the Comission particularly requests a

coments on this matter.

At the time of the final rulemaking on this matter, the Comission '

intends to provide for an interim enforcement policy to supplement the current Enforcement Policy in 10 CFR Part 2, Appendix C, to address violations arising from the proposed regulations. The interim policy would remain in effect for one cycle of the notice and response program, approximately three years.

Under the existing NRC Enforcement Policy significant violations such as those 3

V involving lost sources may result in escalated action including civil penalties. The. interim policy would provide that in the initial phase of the implementation of a notice and response program, enforcement action would not .

normally be taken for violations identified by a licensee in submitting information pursuant.to the proposed regulation provided appropriate corrective action is initiated. This change from the Comission's normal enforcement policy in 10 CFR Part 2 Appendix C, is to remove any disincentive 10 Enclosure y , , ,

i h

to identify deficiencies caused by a concern of potential enforcement action.

This action would be taken to encourage general licensees to search their facilities to assure sources are located, to determine if applicable requirements have been met, and to develop appropri.t. to .ective action when deficiencies are found. However, enforcement action will be considered for violations involving the failure to provide the information requested or tske appropriate corrective actions or willful violations including the submittal of false information. Sanctions in those situations may include civil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a gensal license.

Environmental Impact: Categorical Exclusion The NRC has determined that the proposed regulations are the type of l actiondescribedinthecategoricalexclusion10CFR51.22(c)(3)(iii).

Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.

Paperwork Reduction Act Statement

-The proposed rule amends the information collection requirements that are

ubject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This ,

proposed rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.

The public reporting burden for this collection of information is estimated to average about 20 minutes per response, including time for 11 Enclosure

reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of informatica, it.chding suggesilons for reducing this burden, to the Information and Records Management Branch (MNBB-7714),'d.S.

Nuclear Regulatory Commission, Washington, DC 20555, and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-3019, (3150-0016 and 3150-0001), Office of Management and Budget, Washington, DC 20503.

Regulatory Analysis The NRC has prepared a draft regulatory analysis of this proposed a

regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

Single copies of the draft analysis may be obtained from Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: 301-492-3795.

Regulatory Flexibility Certification Based on information available at this stage of the rulemaking proceeding and in accordance with the Replatory flexibility Act, 5 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic i: pact on a substantial number of small entities. The NRC bcs adopted size standards that classify a small entity as one whose gross annual 12 Enclosure

receipts do not exceed $3.5 million over a 3-year period. The proposed rule affects about 35,000 persons using products under this general license, many of whom would be classified as a small entity. However, the NRC believes that ,

the economic impact cf th: p:;;osed requirements on any general licensee would be negligible. The proposed rule is being issueu to better ensure that the general licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.

Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to these proposed rules and therefore a backfit analysis is not required 4

because these proposed amendments do not involve any provisions that would impose backfits as defined ~in 10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Parts 31 and 32 10 CFR Part 31-Byproduct material, Criminal penalties, Labeling, Nuclear materials, '

Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment.

13 Enclosure L

w , --e -r- v- ,-- , v, , - - ,+ w

10 CFR Part 32 '

Byproduct material, Criminal penalties, Labeling, Nuclear materials.

• Radiatic.. prott.,; tion, Reporting and recordkeeping requirements, and Scientific equipment.

for the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 31 and 32 [

PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL 4

1. The authority citation for Part 31 is revised to read as follows:

Authority: Secs. 81, 16), 183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended. 202, 88 Stat.1242, as amended, 1244 (42 U.S.C. 5841, 5842).

Section 31.6 also issued under sec. 274, 73 Stat 688 (42 U.S.C. 2021),

for the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);

SS31.5(c)(1)-(3)and(5)-(9),31.6,31.8(c),31.10(b),and31.ll(b),(c),and (d) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b);

and 5531.5 (c)(4), (5), (8), and (11), 31.6 (d)-(f), and 31.ll(b) and (e) are issued under sec. 1610,68 Stat.950,astamended(42U.S.C.2201(o)).

2. Section 31.2.is revised te read as follows: S 31.2 Terms and chditions.

14 Enclosure

The general licenses provided in this part are subject to the provision of SS 30.9, 30.14(d), 30.34(a) to (e), 30.41, 30.51 to 30.63, and Parts 19, 20, and 21 of this chapter' unless indicated otherwise in the language of the gancral license.

3. In S 31.4 paragraph (b) is revised to read as follows. S 31.4 V lhformationcollectionrequirements: OMB approval.

• s s s (b) 1he approved information collection requirements contained in this part appear in 55 31.5, 31.6, 31.8, and 31.11.

q f 4 4 M

4. In S 31.5, paragraph (b) is revised and paragraph (c)(ll) is added to read as folio S 31.5 Certain measuring, gauging, or controlling devices.' V

<-~-

+ . s . *

(b) The general license in paragraph (a) of 'this section applies only to byproduct material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to S 32.51 of this chapter or in accordance with the specifications contained in the general license of S 31.6.

(c) * * * /

' Attention is directed particularly to the provisions of the regulations in Part 20 of this chapter that relate to the labeling of containers.

' Persons possessing byproduct material in devices under a general license in S 31.5 before January 15, 1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of 5 31.5 in effect on January 14, 1975, 15 Enclosure

4 (11) Shall respond within 30 calendar days of receipt of a request from the Nuclear Regulator,' Comission to verify the following information and any other such information as may be requested by the Comission as it relates to the general license. Further, the general licensee shall notify the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Comission, Washington D.C. 20555 within 30 calendar days if any of the requested information should change.

(1) Name and complete address of the general licensee.

(ii) Identification of specific inft.rmation about the device, such as:

the manufacturer, model number, the number of devices, type of isotope, and who has performed what service on the device since the last report concerning the device was submitted to the NRC, e

(iii) Name, title, and telephone number of the person who is responsible for the device and for ensuring compliance with the appropriate regulations and requirements.

(iv) Address at which the device is located or used. j (v) Whethertherequirementsof531.5(c)(1)through 1.5c)(10)have been met. g g j

-5. Section 31.6 is amended by revising the section heading and the introductory paragraph and by adding paragraphs (a), (d), (e), and (f) to read <

as-follows:-

& S 31.6 General license to distribute, install, and service devices V '

generally licensed in-S 31.5.

Any person who holds a specific license issued by an Agreement Stato authorizing-the holder to manufacture, distribute, install, or service devices 16 Enclosure r y ,.-mn -.r , ~g w - v --s-- -- . , - - - ~ - - - - , , -

described in 5 31.5 within the Agreemeot State is hereby granted a general

~

license to distribute, install, or service the devices in any non-Agreement State for an unlimited period of time and a general license to distribute, install,orservicethedevicesinoffshorewaters,asdefinedins150.3(f),

provided that:

(a) The Agreement State licensee files the appropriate transfer reports as required by paragraphs (a) and (b) of 5 32.52.

/

r.

(d) The person shall furnish a copy of the general license contained in 5 31.5 of this chapter to each person who is responsible for the byproduct material and for ensuring compliance with the appropriate regulations and requirements.

6 (e) The person shall provide the individual responsible for service of

^

the device with written instructions and precautions necessary to ensure its safe installation, operation, and service. These instructions shall include leak-testing requirements, transfer and reporting requirements, disposal options, including possible costs and reporting requirements for lost or damaged devices.

(f) The person performing routine service / installation or relocation of devices shall notify the appropriate NRC Regional Office listed in Appendix D t

of. Part 20. of this' chapter at least 3 working days prior to engaging in such activities in Non-Agreement States. The. notification shall include the date and location of the activity that will be performed. Prior notification does not apply in cases where a radiological hazard due to an accident or malfunction of the device exists. .

t

17. Enclosure

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l j

l PART 32 - SPEClflC DOMES 11C LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAlHING 8YPRODUCT MATERIAL

6. The authority citation for Part 32 continues to read as follows:

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);

SS 32.13, 32.15 (a), (c), and (d), 32.19, 32.25 (a) and (b), 32.29 (a) and (b), 32.54, 32.55 (a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are issued cr. der sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201 (b)); and SS 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52, 32.56, and 32.210 e

are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

7. Section 32.51a is amended by adding paragraph (c) to read as follows:

ei-- S 32.51a Same: Conditions of licenses, u (c) furnish the individuals identified under S 31.5(c)(ll) or 531.6(d) with written instructions and precautions necessary to ensure safe installation, operation, and service of the device. These instructions must include the leak-testing requirements, transfer and reporting requirements, disposal options including possible costs, and reporting requirements for lost or damaged devices.

8. Section 32.52 is revised to read as follows:

fG- S 32.52 Same: Haterial transfer reports and records. V 18 Enclosure

i i

l r

Each person licensed under s 32.51 or s 31.6 to initially transfer ]

devices to generally licensed persons shall:

(a) Report quarterly to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC- i 20555. and send's copy of the report to the appropriate NRC reg l anal office _

listed in Appendix D of Part 20 of this chapter all transfers of such devices l i

to persons-for use under the general license in s 31.5 of this chapter. The report must be provided either in the format presented in Subpart Eg Prt W

s 32.310. " Transfer Report Format," or on a clear and legible record as f long as all of the data required by the format is included. If :,ne or more intermediate persons temporarily possesses the device at the intended place of i t

! use prior to its possession by the user, the report must include the same i e

information for each intermediary as in Subpart E, s 32.310, and clearly designate that person as an intermediary. If no transfers have been made to persons generally licensed under s 31.5 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must 4

be filed within 30 days of the ind of the calendar quarter.

(b) Report quarterly to the responsible Agreement State agency all n transfers of such devices to persons for use under a general license in an Agreement State's regulations that are equivalent to S 31.5. The report must be provided either in the format in Subpart E, s 32.310. " Transfer Report

~

format," or'on a clear and legible record as long as all of the data required

~

iby the format is included. If one or more intermediate persons temporarily _

-possesses the device at the intended place of use prior to its possession by-  ;

- the user, the report must include the same information for each intermediary- i as in:Subpart E, s 32.310, and clearly designate that person as an?

19 Enclosure. -

if -V d y' '1%w"'mw9rp,,yg g--w yvv w- 94 Fw qu-

l l

, intermediary. If no transfers have been made to persons generally licensed under 5 31.5 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter.

(c) Keep records of all transfers of such devices for each general licensee and in compliance with the above reporting requirements of 5 32.52.

Records required by this section must be maintained for a period of 5 years from the date of the recorded event.

9. Subpart E ction 32.310 s added to 10 CFR Part 32 to read as /

follows:

4 70~Subpart E - Report of Transfer of Byproduct Materials V 46 S 32.310 Transfer Report format.

t/

This section contains the format required by S 32.52.

l 20 Enclosure

_ _ _- _ - - . _ _ . , _ . . _ _ _ _ .. , ,_ - . _ . -[ , . 5_. - . - -

Subpart E-Report of Transfer of Byproduct Materials Section 32.310 - Transfer Report Format NAME OF VENDOR AND LICsNSE NUMBER REPORTING PERIOD FROM TO GENERAL LICENSEE INFORMATION -

COMPANY NAME, STREET, CITY, DEPARTMENT STATE, ZIP CODE PERSON RESPONSIBLE FOR CONTROL OF THE DEVICE 1AME AND IITLE TELEPHONE NUMBER FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY AND UNITS NUMBER NUMBER l

9 e

.- ,~s,. - - --- - . - - . - - - .w

, o f

r

Subject:

Requirements for the Possession of Industrial Devices  :

t Containing Byproduct Material (RIN 3150-AD34).

Dated at Rockville, Maryland this day of 1991. [

for the Nuclear Regulatory Commission.

. i emes N. Taylor Executive Director T for Operat'lo ,

)

4 i t

s 22- Enclosure

t

(' M S S T E l\ h(\RKUP i

. /. .. .. .%% UNITED STATES

?N- r ' '*n NUCLE AR REGULATORY COMMISSION

& ,1 wAsmNOTON, O C. 201%

%,*...*f i a

t The Honorable Bob Graham, Chainnan . . .

Subcommittee on Nuclear Regulation ,

Committee on Environment and Public Works -

United States Senate Washington, DC 20510

Dear Mr. Chairman:

e Enclosed for the information of the subcomittee is a copy of a Notice of Proposed Rulemaking to be pub 11 shad in the Federal Register. 10 CFR Part 31 establishes general licenses for the possession and use of 6yproduct material contained in certain devices. The NRC is proposing to amend these regulations to require the general licensees to provide the NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements _ imposed on persons authorized to distribute byproduct material.J These ch>nge(are being made because th + is7 Ein quateaccountj1giggenerally1c'enseddeQes,andalsoa al lack I of aw ss of ne appropr4 te re ations on the rt of ral licensees.

It is 3nt d pate M the y pose s wil1 eJ e tha ese two problems

[are remedied by more tTlhelf contact between,thF general licens NndtheNRC.)

hGGRT' C. Sincerely.

O N' 4 3.8 '

s Eri'c, S. Beckjo'rd 3irector

+

s Office of Nuclear egulatory Research

Enclosure:

0ENN J V. R LYT H B 0 N , D ' )R E g% g

- Notice of- Proposed Rulemaking or p lt q op e u , y s.,,.j ; g q g cc: 7p #.,ouble a nater Alan K. Simpson

~.

v i

(f' Nt N/;g=..J Y\ q

. . ~ - . + _ , . . . . , . - , ,

, a a

',- ~

l Insert C, Congressional Letter ,

Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience. The general licensee is required to comply with the safety instructions provided' and to have all servicing done by persons with appropriate experience who arc licensed to perform the service. In order to evaluate the effectiveness of the general T.icense program, we have conducted surveys of the users of the devices. Our surveys have .

Indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendan to the possession of the devices. Through these actions RC will be able to provide greater assurance that generall licensed devices are properly handled a'nd disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

4 4

, . - - , ., - - - . , .,-,_m , . . . -

g .. . ,*),, UNITED STATES hD } ,g a NUCLEAR REGULATORY COMMISSION -

1 pg

$ wAsamoTON. o. c, noess e es

• MC 13 WI MEMORANDUM FOR: David L. Meyer, Chief ..

Regulatory Publications Branch Olvision of Freedom of Information and Publications Branch Office of Administration FROM: Sher Bahadur, Chief Regulation Development Branch Division of Regulatory Applications .

Office of Nuclear Regulatory Research

SUBJECT:

PUBLICATION OF FEDERAL REGISTER NOTICE f By an SRM dated November 29, 1991 (Enclosure 1), the Commission has approved for publication in the Federal Beaister, a proposed rule entitled the

" Requirements for the Possession of Industrial Devices Containing Byproduct Material" set out in SECY 91-275.

The changes in the Federal Reaister notice directed by the Commission have been made and the Executive Director for Operations signed the notice on ,

December 12, 1991. Enclosed is the signed Federal agaister notice and 13 copies per request (Enclosure 2), as well as a marked-up copy of the notice (Enclosure 3), showing Commission-directed and other editorial changes.

Please implement the Commission's action by arranging for publication of the enclosed proposed rule, allowing 75 days for public comment.

Also enclosed is a Congressional letter package (Enclosure 4) for transmittal to the Office of Congressional Affairs and a Public Announcement (Enclosure 5) for transmittal to the Office of Public Affairs.

In addition, enclosed is a copy of the Draft Regulatory Analysis (Enclosure 6) for transmittal to the Public Document Room.

E

^

I .

I DEC 181991 David L. Heyer, Chief 2 If you have any questions, please call Joe Mate (x23795) of my steif.

h ---

Sher Bahadur, Chief Regulation Develonment. Branch Division of Regulatory Applications Office of Nuclear Regulatory Research

Enclosures:

1. Staff Requirements Memo

2. FR Notice with 13 Copies

3. Marked-Up Copy of FR Notice

4. Congressional Letters

5. Public Announcement

6. Oraft Regulatory Analysis a

1

David L. Meyer, Chief 2 DEC 181991 If you have any questions, please call Joe Mate (23795) of my staff.

Odginal Signed Bn Sher Bahadur, Chief Regulation Development Branch Divisig.n_of Regulatory Applications Office of Nuclear Regulatory Research

Enclosures:

1. Staff Requirements Memo

2. FR Notice with 13 Copies

3. Marked-Up Copy of FR Notice

4. Congressional Letters S. Public Annour.coment

6. Draft Regulatory Analysis 6

Distribution: (MEYERPAC)

Subj-circ-chron Reading Files \SBahadur EBeckjord CHeltemes BMorris FCostanzi MFleishman JMate

• SEE PREVIDUS CONCURRENCE Offe: RDB:DRA:RES RDB:DRA:RES RDB:DRA:RES 0 . . 0:DRA:RES 0- . DiRES Name: JMate:lc* MFleishman* SBahadur FCostanzi CHeltemes EBeckjord Date: 12/17/91 12/17/91 12/t1/91 1 12/ /91 L 12/ /91

. OFFICIAL RECORD COPY i

---

r-,-----,-, - - - , - -n , - w- ----,--,m- m O" W Y ENCLOSURE 1 4

~~

Action: Beckjord, RES Cys: Taylor

[g.e eeeg'#o UNITED STATES NUCLEAR REGULATORY COMMISSION Sniezek Thompson j, P) oi W ASHINGT ON. D.C. 20555 Blaha e Bernero, HMSS

'%*****#,/ November 29, 1991 Lieberman, OE OFFICE OF TH Kammerer. SP ,

scentTAny ditte, RES Scroggins OC Meyer, ADM Shelton, IRM MEMORANDUM TCTa - James H. Taylor Executive Director for crations FROM: Samuel J. Chilk, Secrets y St*BJECT: SECY-91-275 - PROPOSED Et DMENTS TO 10 CFR PART 31, " GENERAL DOMES ICJ LICENSES FOR BYPRODUCT MATERIAL," AN 10 CFR PART 32,

" SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL" The Commission (with all Commissioners agreeing) has approved issuance of the proposed amendments to 10 CFR Parts 31 and 32 as a proposed rule subject to the changes in the attachment.

-(EDO.)- (RES) (SECY Suspense: 12/20/91) 8900090 4

The following comments are provided:

1) The discussion of Agreement State licensees and regulatory programs in the Statements of Consideration should be amplified to reflect the staff responses to several of See the insert on page 5 Commissioner Curtiss' questions.

of the notice.

2) The regulatory framework and applicability to older sources should be added the Statements of Consideration consistent with the staff responses to Commissioner Curtiss' questions 5 and 6. See the insert on page 7 of the notice.

3) On page 6, the discussion of potential changes to the scope of general-licensed devices should be deleted. Mentioning the possibility of future such changes is not ralevant to these amendments at this time and the proposed language would likely cause confusion.

4) The letters to Congress should be modified as shown in the attachments to be more consistent with the summary and background sections of the notice.

SECY NOTE: THIS SRM, SECY-91-275, AND THE VOTE SHEETS OF THE CHAIRMAN, AND COMMISSIONERS ROGERS AND CURTISS WILL BE MADE PUBLICLY AVAILABLE 10 WORKING DAYS FROM THE DATE OF THIS SRM

l

5) The staff response to Commissioner Curtiss' questions 8 and 9 indicate that no special monitoring or inspection of how well manufacturers and distributors may be complying with the new reporting requirements is anticipated. He plans to revisit the compliance issue when the final rule is submitted for Commission approval.

Attachment:

As stated cc: The Chairman Commissioner Rogers Commissioner Curtiss Commissioner Remick OGC OIG 4

1

-- -- - - - - - - - - __,_____m_____________ _____ _

storage of devices in warehouses, disposal in scrap yards, incineration of waste, melting in a smelter, and disposal in a landfill. Included in the risk assessment was an incident at a steel company in 1983 (discussed in NUREG-1188, "The Auburn Steel Company Radioactive Contamination Incident") that probably represents a worst-case scenario for generally licensed gauging devices. Although individual doses were low and within aforementioned limits for exposure of members of the public, they nevertheless represent unnecessary additional public exposure that could have been avoided. In addition, the cleanup costs were in excess of four million dollars with additional costs incurred for the staff efforts of regulatory agencies.

In consideration of both the risk assessment and incidents like those noted above, the NRC conducted a three-year sampling (1984 thru 1986) of a

general licensees (taken from the vendors' quarterly reports) to determine whether there was an accounting problem with gauge users under general licenses, and if so, what remedial action might be necessary. The sampling was conducted both by telephone calls and site visits. The sampling revealed several areas of concern about the use si radioactive material under the general license provisions. On the basis of the sampling, the NRC concluded that there is (1) a lack of awareness of appropriate regulations on the part of the user (general licensee) and (2) inadequate handling and accounting for these generally licensed devices. The NRC further concluded that these two problems could be remedied by more frequent and timely contact between the general licensee and the NRC. This conclusion by the NRC provides the basis D q for the regulatory changes proposed in this action.{Th ule would ea ma m atibil for reement St tes. The Agree tates par 14ciy1 ed in the deve Lof-th s rule. es o oposed Nle gg 4 5 Enclosure

Insert A, page 5 An estimated 70,000 Agreement State licensees use the types of sources and devices covered by the' amendments being proposed today for NRC's general licensees, consequently, the States will play an important role in achieving improved regulatory oversight on a national basis. Many of the States already have accountability programs in place. The Agreement States participated in the development of this rule and indicated agreement with the concept of the proposed rule. Specific comments from the Agreement States were adopted except for suggestions that NRC charge general licensees fees and that there is no need for a standard format for submitting information. The fee issue will be addressed separately. The proposed rule provides flexibility in the use of the standard format.

The Commission is considering making the amendments a matter of compatibility fo,v the States. NRC staff has suggested'that the amendments be categorized as Division 2 level of compatibility.

This level of compatibility requires that States address provisions in NRC regulations relating to basic principles of radiation cafety and regulatory functions without necessarily using identical language. States may also adopt requicements more restrictive than NRC rules under this level of compatibility. The NRC would appreciate comments on this suggestion. ,

A __

were circulated to the Agreement States. They have supported the rulemaking -

and al their comments were considered and incorporated as appr riate.

The ris ssessment and the sampling above also led the mission to Q conclude that for small group (a few hundred) of gener y licensed gama gauges the radiation r , though small in an absolu sense, may be sufficient to warrant their nyersion to specif licenses. In addition, thera also appears to be another, larger gr p of generally licensed devices (about 10,000) where the radiation r s estimated to be very low. These devices, e.g., beta backscatter ga es an nalytical devices ma) be candidates for exemption from rther regulatio under the Comission's BRC Policy. The Commission i considering these action This proposed regulation addresses e vast majority of generally licei ed devices that fall 4

in the middle of e risk spectrum. For these devices, the r k is small to the extent t t specific licensing can not be justified. But neit is it so small, ecially in consideration of the very large numbers of such devices }

(ext t, that exemptions would appear to be appropriate. [

An estimated 35,000 persons use certain measuring, gauging, or tMc 's controllingdevicesunderpgenerallicense. NRC regulations that affect these general licensees' responsibilities and that are presently being amended are 10 CFR 31.2, 31.4, 31.5, and 31.6. Under 10 CFR 31.2, " Terms and Conditions," all general licensees are subject to certain provisions of Part 30 and also Parts 19, 20, and 21. The proposed revision to 5 31.2 would also subject all general licensees to the requirements of 10 CFR 30.9,

" Completeness and Accuracy of Information," which imposes certain requirements regarding the completeness and accuracy of the information submitted to NRC by licensees not now imposed upon general licensees.

6 Enclosure

[

I ,

Section 31.4 of 10 CFR Part 31, "Information Collection Requirements:

OMB approval " lists the various sections of Part 31 that contain approved information collection requirements. Paragraph b of 5 31.4 is being amended to add 5 31.6 to the approved listing.

Section 31.5, "Certain measuring, gauging or controlling devices,"

provides for a general licensee to acquire, receive, possess, use, or transfer byproduct materials, it also specifies the responsibilities of general licensees regarding the use of byproduct materials. Under the proposed revisions a new paragraph (c)(11) would be added to require the general licensee to provide specific information to the NRC upon request. This information would include the complete name and address; specific information about the device, such as manufacturer, model number, and number of devices; e

name, title, and telephone number of the person responsible for controlling the use of the device; the address where the device is located or used; and whether the specific requirements of paragraph (c) of 5 31.5 have been met.

In addition, a proposed revision to paragraph (b) of 5 31.5 would delete all references to specific licenses issued by Agreement States that authorize distribution of devices to persons generally licensed by Agreement States.

INSEE.T  %

3 At present,10 CFR 31.6, " General license to install devices generally licensed in 5 31.5," provides a general license to certain specific licensees from Agreement States to install or service devices used under 5 31.5. The current regulation,10 CFR 31.6, is not clear with respect to time restrictions. Paragraph 150.20 (b)(3) of 10 CFR Part 150 imposes a 180-day-per-calendar-year limitation on the activities of Agreement State Licensees in non-Agreement States. The proposed amendments to 5 31.6 would remove this restriction for 5 31.5 licensees. This change will be convenient to the NRC, 7 Enclosure

i Insert B, page 7 The registration and verification system contained in the proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees, including those who previously acquired radioactive sources. If older sources are transferred, they would be subject to the same requirements as never sources and the registration system is intended to capture them. General licensee transfers of sources are limited to either transfer to specific licensees or other general licensees by the existing provisions of 10 CFR 31.5(c) (8) and (9). In both cases, licensees must notify NRC of the transfers. If the specific licensee is a 10 CFR Part 32 or Agreement State equivalent distributor, the reporting requirements of the proposed rule would apply to any subsequent transfers. The current NRC data base, although limited, includes identification of general licensees who acquired gauges as early as 1959. NRC staff plans to contact these licensees and any new general licensee as part of the enhanced oversight effort.

e 4

.fge n s a,,),

UNITED STATES

!' , a NUCLEAR REGULATORY COMMISSION wash 1NGTO N, D. C. 20555 i/

\; ~... ],I The Honorable Bob Graham, Chairman Subcomittee on Nuclear Regulation . .

Comittee on Environment and Public Works United States Senate Washington, DC 20510

Dear Mr. Chairman:

Enclosed for the information of the subcomittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Register. 10.CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is proposing to amend these regulations to require the general licensees to provide the NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distriSutebyproductmaterial.fThesechyngatarebeingmadebecauseth is L in auste account 3pg T _ generally 1Kensed hices, and also a al lack of av ~ ss of e approp te re ations on the rt of ral licensees, it is3 cip te the g pose s will e e tha ese tro problems are remedied by more t elf contact between general licens ndtheNRC.)

h ssRT C. Sincerely, G

Q .

Eric S. BeckJord )irector Office of Nuclear egulatory Research

Enclosure:

Notice of proposed Rulemaking cc: Senator Alan K. Simpson

Insert C, Congressional Letter Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience. The general licensee is required to comply with the safety instructions provided and to have all servicing done by persons with appropriate experience who are licensed to perform the service. In order to evaluate the effectiveness of the general license program, we have conducted surveys of the users of the devices, our_ surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Through these actions, HRC will be able to provide greater assurance.that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

4

M M -

ENCLOSURE 2 6

t-

[7590-01]

NUCLEAR REGULATORY COMMISSION 10 CfR Part: 31 and 32 C; R 'i C , N ts L rqy AGENCY:

ACTION: Proposeo rule.

SUMMARY

The .uclear Regulatory Connission (NRC) is proposing to amend its regulations governing the safe use of byproduct material in certain measuring, gauging, or controlling devices. The proposed changes, among other things, would require general licensees who possess these devices to provide the NRC information about the identification of devices and the people responsible for the devices. - Further, specific licensees who are distributors of generally

' licensed devices under 10 CFR 31.5 would be required to use a uniform format when submitting the quarterly transfer reports to NRC. The proposed rule is intended to ensure that general licensees are aware of and understand the

, requirements for the possession-of devices containing byproduct material.

This awareness will better assure that general licensees will comply with the-1

requirements for proper handling and disposal of generally licensed devices .:

- and presumably reduce the-potential for incidents that could result in unnecessary radiation exposure to the public.

DATE: The comment period expires 75 days after publication. Comments received after this date will be considered if it is practicable to do so, but the NRC is able to ensure consideration only for comments received on or before this date.

ADDRESSES: Mail written comments to the Secretary, U.S. Nuclear Regulatory 4 Commission, Washington, DC 20555, Attention: Docketing and Service Branch.

, Deliver comments to One White Flint North,11555 Rockville Pike, Rockville, a

MO, between 7:30 am and 4:15 pm on weekdays. Copies of the draft regulatory

analysis, as well as copies of the comments received on the proposed rule, may be examined at the NRC Public Document Room, 2120 L Street NW, (Lower Level),

Washington, DC.

FOR FURTHER INFORMATION CONTACT: Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3795.

2

i .

SUPPLEMENTARY INFORMATION: ,

Background

On February 12, 1959 (24 FR 1089), the Atomic Energy Commission amended its regulations to provide a general license for the use of byproduct material contained in certain luminous, measuring, gauging, and controlling devices.

Under the current requirements for possession of a general license, certain persons may receive and use a device containing byproduct material if the device has been manufactured and distributed in accordance with the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license is issued based upon a determination by a a

regulatory authority that the safety features of the device and the instructions for safe operation are adequate and meet regulatory requirements.

The general licensee is required to comply with the safety instructions contained in or referenced on the label of the device and to have the testing or servicing of the device performed by an individual authorized to manufacture, install, or service these devices. A generally licensed device is a " black box," that is, the radioactive material is contained in a sealed source usually within a shielded device. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. Thus, the general license policy is a mechanism to simplify the license process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary.

3

_ _ _ . . _ _ _ _ _ . _ _ _ _ . _ _ __._m_______._ ______ __.____,_

Discussion .

Teere are about 600,000 devices that contain byproduct material in use by about 35,000 licensees under the Commission's general licent- regulatory program. General licensees have not been contacted by NRC on a regular basis because of the relatively small radiation risk posed by generally licensed devices. These devices have survived fires and explosions on many occasions without a total loss of shielding. They have been damaged by molten steel, and hit by construction vehicles with only minor losses in radiation shielding while maintaining the integrity of the source capsule.

Nonetheless, there have been a number of occurrences where devices containing radioactive material have not been properly handled or disposed of 4

and resulted in radiation exposure of the public. Although no significant public health and safety hazards resulted from these incidents, if proper handling and disposal procedures had been followed, these avoidable exposures would not have occurred. For example, one or more cesium-type gauges were mixed in with some scrap metal that was melted down to form steel and the entire batch of steel was contaminated. In another instance, a static eliminator bar with 22.5 millicuries of americium-241 was sent to a sanitary landfill over which the NRC has no jurisdiction. There have been othei types of incidents involving NRC generally licer, sed devices including damaged devices, leaking or contaminated sources, and equipment malfunctions.

However, loss of accountability, as occurred above, remains the most frequent incident and the predominant concern.

Because of these occurrences, the NRC's Office of Nuclear Material Safety and Safeguards (NMSS) conducted a radiological risk assessment addressing 1 4

)

storage of devices in warehouses, disposal in scrap yards, incineration of waste, melting in a smelter, and disposal in a landfill. NMSS included in the risk assessment an incident at a steel company in 1983 (discussed in NUREG-1188, "The Auburn Steel-Company Radioactive Contamination Incident") that

probably represents a worst-case scenario for generally licensed gauging devices. -Although individual doses were low and within prescribed limits for ,

- exposure of members of the public, they nevertheless represent unnecessary additional public exposure that could have been avoided. In addition, the cleanup costs were in excess of four million dollars with additional costs

, incurred for the staff efforts of regulatory agencies.

, In consideration of both_the. risk assessment and incidents like those

! noted above, the NRC conducted a three-year sampling (1984 thru 1986) of 1 4 general licensees (taken from the vendors' quarterly reports) to determine whether there was_ an accounting problem with gauge users under general

licenses, and if so, what remedial action might be necessary. The sampling -

! was conducted both by telephone calls and site visits. The sampling revealed several areas of concern regarding the use of radioactive material under the general-license provisions. On-the basis of the sampling, the NRC concluded

' that there is: :(1); a lack of awareness of appropriate regulations on the part L of the user (general-licensee) and (2) inadequate handling and accounting for

- these generally licensed devices.1 The NRC further concluded that these two problems could be remedied by more frequent and timely contact between the general-licensee and the NRC~. This conclusion by the NRC provides.the-basis-for the regulatory changes proposed in this action.

5 ,

._ , - , . . . - . . - . -------,,,c,. - - - ..-,-w , , + - - - - , - - - - . - - , - . , ,n . ,.. , - ~ -

An estimated 70,000 Agreem.ent State licensees use the types of sources and devices covered by the amendments being proposed today for the NRC's general licensees. Consequently, the States will play an important role in achieving improved regulatory oversight on a national basis. Many of the States already have accountability progran in place. The Agreement States participated in the development of this rule and indicated agreement with the concept of the proposed rule. Specific coments from the Agreement States were adopted except for suggestions that the NRC charge general licensees fees and that there is no need for a standard format for submitting information.

The fee issue will be addressed separately. The proposed rule provides flexibility in the use of the standard format.

The Comission is considering making the amendments a matter of compatibility for the States. The NRC staff has suggested that the amendments be categorized as Division 2 level of compatibility. This level of compatibility requires that States address provisions in NRC regulations relating to basic principles of radiation safety and regulatory functions without necessarily using identical language. States may also adopt requirements more restrictive than NRC rules under this level of compatibility. The Comission would appreciate coments on this suggestion.

An estimated 35,000 persons use certain measuring, gauging, or controlling devices under the NRC's general license. NRC regulations that affect these general licensees' responsibilities and that are presently being amended are-10 CFR 31.2, 31.4, 31.5, and 31.6. Under 10 CFR 31.2, " Terms and Conditions," all general licensees are subject to certain provisions of Part

,30 and also Parts 19, 20, and 21. The proposed revision to i 31.2 would also 6

l ,.

subject all general licensees to the requirements of 10 CFR 30.9,

" Completeness and Accuracy of Information," which imposes certain requirements regarding the completeness and accuracy of the information submitted to the NRC by licensees not now imposed upon general licensees.

Section 31.4 of 10 CFR Part 31, "Information Collection Requirements:

OMB approval " lists the various sections of Part 31 that contain approved information collection requirements. Paragraph (b) of 5 31.4 is being amended to add i 31.6 to the approved listing.

Section 31.5, "Certain measuring, gauging or controlling devices,"

provides for a general licensee to acquire, receive, possess, use, or transfer byproduct materials, it also specifies the responsibilities of general Itcensees regarding the use of byproduct materials. Under the proposed a

revisions a new paragraph (c)(11) would be added to require the general licensee to provide specific information to the NRC upon requast. This information would include the complete name and address; specific information about the device, such as manufacturer, model number, and number of devices; name, title, and telephone number of the person responsible for controlling the use of the device; the address where the device is located or used; and whether the specific requirements of paragraph (c) of 5 31.5 have been met.

In addition, a proposed revision to paragraph (b) of 9 31.5 would delete all references to specific licenses issued by Agreement States that authorize distribution of devices to persons generally licensed by Agreement States.

The registration and verification system contained in the proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees, including those who previously acquired radioactive sources. If older sources 7

4 T r

+

i

-are_ transferred, they would be subject to-the same requirements as newer <

sources and the registration system is intended to capture them. General licensee transfers of sources are limited to either transfer to-specific '

. licensees-or other_ general licensees by the existing provisions of-10.CFR -

31.5(c)_(8) and (9). In both cases, licensees must notify the NRC of the transfers. -If the specific licensee is a 10 CFR Part 32 or Agreement State i

equivalent _ distributor, the reporting requirements of the proposed rule would

applyfto any subsequent transfers. The_ current NRC data base, although-limited, _ includes identification of general licensees who acquired gauges as

early as 1959. The NRC staff plans to-contact these licensees and any new general licensee as part of the enhanced oversight effort. .

At present,10 CFR 31.6, " General license to install devices generally 6

i licensed in i 31.5," provides a general license to certain-specific licensees from Agreement States to install or service devices used under i 31.5. The

[ current regulation,10 CFR 31.6, is not clear with respect to time restrictions. 10 CFR 150.20(b)(3), imposes a 180-day-per-calendar-year limitation on the activities of Agreement State Licensees in non-Agreement States. The proposed amendments to i 31.6 would remove this restriction for 1 31.5 licensees. This change will be_ convenient-to the NRC, Agreenent States, fand manufacturers because it will reduce and simplify paper work without increasing the risk to public health and-safety. The proposed i

.31.6 (a) would require the general licensee holding a specific license from an Agreement StateLto report to the NRC all persons receiving a device from the licensee, as specified in the accompanying proposed revision to i 32.52.

Proposed i 31.6 (d)_ would require the licensee to ' supply each of the 8 ,

l recipients of a generally licensed device a copy of the general license contained in i 31.5. Proposed i 31.6 (e) would require that written instruc-tions and precautions be provided to persons servicing a generally licensed device. Proposed i 31.6 (f) would also require a person performing routha --

installation / servicing / relocation of these devices to notify the appropriate NRC regional office at least 3 working days prior to the start of the

- activities. This notification would allow for a level of periodic inspection of those activities that intentionally place a worker in direct contact with

the device or an unshielded radiation source. It is not intended that the l

l prior notification requirement apply in cases where a radiological hazard due to an accident or a malfunction of the device exists. To be consistent with the proposed modifications, the section heading would be amended to read 4

" General license to distribute, install, and service devices generally licensed in i 31.5."

10 CFR 32.51a, "Same: Conditions of licenses," presently imposes L

i conditions on applicants for a specific license to manufacture or initially 1'

l- transfer generally licensed devices to general licensees. The addition of l

l proposed paragraph (c) to i 32.51a would require such specific licensees to l

provide recipient users of generally licensed devices with written instructions and precautions to ensure that the devices are-used safely. In

i. addition, these specific licensees would be required to provide those users l

l with information regarding testing requirements, transfer and reporting requirements, and disposal options for the devices being transferred.

l 10-CFR 32.52, " Material transfer reports and records," currently requires specific licensees authorized to distribute devices to general licensees to I

9 l .

file transfer reports _with the NRC on a quarterly basis. The revised regulation would prescribe the format to be used when submitting transfer reports to the NRC. The proposed format would provide more detailed and complete information about the general licensee to whom the da;c. i.-

transferred. The format is presented in proposed Subpart E, 6 32.310.

Licensees who do not use the prescribed format would be permitted to provide all of the information required by the format on a clear and legible record.

In addition, specific licensees would be required to identify a person responsible for meeting the requirements associated with the possession of the generally licensed device rather than simply identifying a point of contact at the general licensee's location.

After receipt of the quarterly transfer reports from the specific 4

licensee under i 32.52, the NRC would send letters to the general licensees who received the devices during the preceding reporting period requesting them to verify in writing that they had purchased the devices containing byproduct material and that they understand the requirements of the general license.

The general licensee under proposed i 31.5(c)(ll)(ii) would be required to respond to the NRC by letter and to verify safety-related information about the device and its location. Thereafter, notices would be sent periodically to the general licensees requesting that they verify that they still have the device, verify the safety-related information, and remind them of their regulatory responsibilities in using the device. The frequency of these letters may range from 1 to 3 years. Any failure to respond or any reports of lost devices would initiate NRC follow-up action. -This contact between the NRC and the general licensee would allow the NRC to validate and update the 10

information currently' contained in the data base that the NRC maintains for its general licensees.

Although these proposed requirements would impose additional costs on licensees, the Commission has estimated these to be r.cataci (on the order of

$10 per device). Accordingly, the Commission believes that the increased compliance by general licensees and confidence in the appropriateness of the general license program potentially afforded by these new requirements outweigh this cost. Nonetheless, the Commission particularly requests comments on this matter.

At the time of the final rulemaking on this matter, the Commission intends to provide for an interim enforcement policy to supplement the current Enforcement Policy in 10 CFR Part 2, Appendix C, to address violations arising a

from the proposed regulations. The interim policy would remain in effect for

- one cycle of the notice and response program, approximately three years.

Under the existing NRC Enforcement Policy, significant violations such as those involving lost sources may result in escalated action including civil penalties. The interim policy would provide that in the initial phase of the implementation of a notice and response program, enforcement action would not normally be taken for violations identified by a licensee in submitting

- information pursuant to the proposed regulation provided appropriate corrective action is initiated. This change from the Commission's normal enforcement policy in 10 CFR Part 2, Appendix C, is to remove any disincentive

- to identify deficiencies caused by a concern of potential enforcement action.

This action would be taken to encourage general licensees to search their

, facilities to assure sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective action when 11

.- - . - - - ~ . _ .- ~- . - - -

deficiencies are found. However, enforcement action will be considered for >

violations involving the failure to provide the information requested or take appropriate corrective actions or willful violations including the submittal of false information. Sanctions ir. th:::-:ituations may include civil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a general license.

Environmental Impact: Categorical Exclusion

• The NRC has determined that the proposed regulations are the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii).

Therefore, neither an environmental impact statement nor an environmental 4

assessment has been prepared for this proposed regulation.

Paperwork Reduction Act Statement The proposed rule amends the information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This proposed rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.

The public reporting burden for this collection of information is estimated to average about 20 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing-and reviewing the collection of information.- Send comments regarding this burden estimate or any other aspect of this collection of information, . including suggestions for reducing this 12

= burden, to the Information and Records Management Branch (MNBB-7714), U.S.

Nuclear kegulatory Commission, Washington, DC 20555, and to the Desk Officer, Office of Information and Regulatory Affairs, NE08-3019, (3150-0016 and 3150-0001), Office of Man!Cemer.t. nd Budget, Washington, DC 20503.

Regulatory Analysis

' The NRC has prepared a draft regulatory analysis of this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

Single copies of the draft analysis may be obtained from Joseph J. Mate, 4

Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: 301-492-3795.

Regulatory Flexibility Certification Based on information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic impact on a substantial number of small entities. The NRC has adopted size standards that classify a small entity as one whose gross annual receipts do not exceed $3.5 million over a 3-year period. The proposed rule affects about 35,000 persons using' products under this general license, many of whom would be classified as a small entity. However, the NRC believes that the economic impact of the proposed requirements on any general lie.ensee would 13

- e_., .

.be negligible. The proposed rule is being issued to better ensure that the .

general licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.

Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not

-apply to these proposed rules and therefore a backfit analysis is 'not required because these proposed amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Parts 31 and 32 4

10 CFR Part 31 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment.

10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection,. Reporting and recordkeeping requirements, and Scientific equipment.

.14

l For the reasons set out in the p.eamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following trendrents to 10 CFR Parts 31 and 32.

PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT HATERIAL

1. The authority citation for Part 31 is revised to read as follows:

Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842).

Section 31.6 also issued under sec. 274, 73 Stat 688 (42 U.S.C. 2021).

4 For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);

il31.5 (c)(1)-(3) and (5)-(9), 31.6, 31.8(c), 31.10(b), and 31.11(b), (c),

and (d) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C.

2201(b); and 1931.5 (c)(4), (5), (8), and (11), 31.6 (d)-(f), and 31.11(b) and (e) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C.

2201(o)).

2. Section 31.2 is revised to read as follows:

6 31.2 Terms and conditions.

The general licenses provided in this part are subject to the provision of il 30.9, 30.14(d), 30.34(a) to (e), 30.41, 30.51 to 30.63, and Parts 19, i

15

20, and 21 of this chapter' unless indicated otherwise in the language of the general Itcense.

. 3. In 6 31.4 paragraph (b) is revised to read as follows:

i 31.4 Information collection requirements: OMB approval.

(b) The approved information collection requirements contained in this part appear in il 31.5, 31.6, 31.8, and 31.11.

4. In 6 31.5, paragraph (b) is revised and paragraph (c)(ll) is ajded to read as follows:

6 6 31.5 Certain measuring, g.nuging, or controlling devices.'

(b) The general license in paragraph (a) of this section applies only to byproduct material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to i 32.51 of thic chapter or in accordance with the specifications contained in the general license of i 31.6.

(c)

' Attention is directed particularly to the provisions of the regulations in Part 20 of this chapter that relate to the labeling of containers.

' Persons possessing byproduct material in devices under a general license in i 31.5 before January 15, 1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of i 31.5 in effect on January 14, 1975.

16

__.___________________________________m__ -_____ -

\

(11) Shall respond within 30 calendar days of receipt of a request from the Nuclear Regulatory Commission to verify the following information and any other such information as may be requested by the Commission as it relates to the general license. Further, the general licensee shall notify the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington D.C. 20555 within 30 calendar days if any of the requested information should change.

(1) Name and complete address of the general licensee.

(ii) Identification of specific information about the device, such as:

the manufacturer, model number, the number of devices, type of isotope, and who has performed what service on the device since the last report concerning the device was submitted to the NRC.

6 (iii) Name, title, and telephone number of the person who is responsible

'or the device and for ensuring compliance with the appropriate regulations and requirements.

(iv) Address at which the device is located or used.

(v) Whether the requirements of i 31.5(c)(1) through (c)(10) have been met.

5. Section 31.6 is amended by revising the section heading and the introductory paragraph and by adding paragraphs (a), (d), (e), and (f) to read as follows:

i 31.6 General license to distribute, install, and service devices generally licensed in i 31.5.

11

I Any person who holds a spegific license issned by an Agreement State authorizing the holder to manufacture, distribute, install, or service devices described in i 31.5 within the Agreement Stati is hereby granted a general license to distribute, install, or service the devices in any non-Agreement State for an unlimited period of time and a general license to distribute, install, or service the devices in offshore waters, as defined in i 150.3(f),

provided that:

(a) The Agreenent State licensee files the appropriate transfer reports as required by paragraphs (a) and (b) of i 32.52.

(d) The person shall furnish a copy of the general licente contained in i 31.5 of this chapter to each person who is responsible for the byproduct a

material and for ensuring compliance with the appropriate regulations and requirements.

(e) The person shall provide the individual responsible for service of the device with written instructions and precautions necessary to ensure its safe installation, operation, and service. These instructions shall include leak-testing requirenants, transfer and reporting requirements, disposal options, including possible costs and reporting requirements for lost or damaged devices.

(f) The person performing routine service / installation or relocation of devices shall notify the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter at least 3 working days prior to engaging in such activities in Non-Agreement States. The notification shall include the date and location of the activity that will be performed. Prior notification does 18 y., s -- v -,

i

.. i a

not apply in cas,es where a radiological hazard due to an-accident or I malfunction of the device exists.

t PART 32 - SPECIFIC'DONESTIC LICENSES TO MANUFACTURE OR  ;

- TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL 4 6. The authority citation for Part 32 continues to read as follows:

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);

il 32.13, 32.15 (a), (c), and (d), 32.19, 32.25 (a) and (b), 32.29 (a) and 4

(b). 32.54, 32.55 (a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201 (b)); and  !

il 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52, 32.56, and 32.210 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

7. Section 32.51a is amended by adding paragraph (c) to read as follows:

i 32.51a Same: Conditions of licenses.

, e * * * *

(c) Furnish the individuals identified under i 31.5(c)(11) or 131.6(d) with written instructions and precautions necessary to ensure safe installation, operation, and service of.the device. These instructions must

-include the leak-testing requirements, transfer and reporting requirements,  ;

19 9

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f i

disposal options including pessible costs, and reporting requirements for lost  ;

or damaged devices.

i +

C. % tion 32.52 is revised'to read as follows:

6 32.52 Same: Material transfer reports and records.  ;

~

Each person licensed under i 32.51 or i 31.6 to initially transfer devices to generally licensed persons shall .

i i (a) Report quarterly to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC

^

[ 20555, and send a copy of the report to the appropriate NRC regional office listed in Appendix 0 of Part 20 of this chapter all transfers of such devices 4: .

to persons for use under the general license in i 31.5 of this chapter. The 4

report must be provided either in the format presented in Subpart E, 6 32.310, ' Transfer Report Format," or on a clear and legible record as long as all of the data-required by the format is included. If one or more inter-

,- mediate persons temporarily possesses the device at the Intended place of use prior to its possession by the user, the report must include the same information for each intermediary as in Subpart E, i 32.310, and clearly i ' designate that person as an intermediary. If no transfers have been made-to persons generally licensed under i 31.5 during the reporting period, the report must so indicate. The report must cover each calendar. quarter and must

- be filed within 30 days of the end of the calendar; quarter.

.(b). Report quarterly to the responsible Agreement State agency all i' transfers of such devices to persons for. use under a general license in an .

T Agreement State's regulations-that are equivalent to i 31.5. The report must I

20

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_. _ _. _ _ _ . _ _ . _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ . _ _.- _ . _ . . _ . . _ . . . ~ .

I be provided either in the format in Subpart E, 6 32.310. " Transfer Report

~

Format," or on a clear and legible record as long as all of the data required -

by the format is included. If one or more intermediate persons temporarily

• - possesses the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediary.

as in Subpart E, I 32.310, and clearly designate that person as an intermediary. If no transfers have been made to persons generally licensed ender i 31.5 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter.

(c) Keep records of all transfers of such devices for each general licensee and in compliance with the above reporting requirements of i 32.52.

4 Records required by this section must be maintained for a period of 5 years  ;

from the date of the recorded event.

9. Subpart E. Section 32.310 is added to 10 CFR Part 32 to read as follows: ,

Subpart E - Report of Transfer of Byproduct Materials i 32.310 Transfer Report Format.

This section contains the format required by i 32.52.

21-

. i i

- . ,, .,mJ r . . - . - - - . - . .._..-,-.-r-.:..~,.

i Subpart E-Report of Transfer of Byproduct i Materials Section 32.310 - Transfer Report Format NAME OF VENDOR AND LICsNSE NUMBER REPORTING PERIOD FROM TO GENERAL LICENSEE INFORMATION COMPANY NAME, STREET, CITY, DEPARTMENT STATE, ZIP CODE d

2ERSON RESPONSIBLE FOR CONTROL OF THE DEVICE 1AME ANDaTITLE TELEPHONE NUMBER FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY AND UNITS NUMBER NUMBER 4

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I

Subject:

Requirements for t.he Possession of Industrial Devices 1 Containing Byproduct Material (RIN 3150-A034).

Dated at Rockville, Maryland this /A day of / b 1991.

For the Nuclear Regulatory Commission.

i /

\

M/ '

me M.Taylo/

E utive Director for Operations e

1 i

4

- 23 '

. t

i 1

I

Subject:

Requirements for the Possession of Industrial Devices Containing Byproduct Material (RIN 3150-AD34).

Dated at Rockville, Maryland this /4 day of h A u s1991. '

For the Nuclear Regulatory Commission.

5 Original Slined By: ,

' h cs M. Taylor James M. Taylor  ;

Executive Director for Operations 4

l EDO~

-JTaylor 12/ /91-

-~

23

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4 I

l 1

l 4

ENCLOSURE 3 4

4-b1 ASTER Mggygp ,

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(7590-01)  :

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+tecm-atemen =:C:

NUCLEAR REGULATORY COMMIS$10N- , , , , ,

10 CFR Parts 31 and 32-RIN 3150 - AD34 ,

S' ,

Requirement g for the Pcssession of Industrial / ,

Devices Containing Byproduct Material l

AGENCY: Nuc1IarRegulatoryCommission. r ACTION: Proposed rule. '

t

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the safe use of byproduct material in certain measuring, gauging, or controlling devices. The proposed changes, among other things, would require general licensees who possess these devices to provide the NRC .

information about the identification of devices and the people responsible for spey.t. ucent ses w* An.t j ,

the devices. Further.gdistributors of generally licensed devices under 10 CFR V

1.5;hqeW1'tN11een'wh) would be required to use a uniform format when submitting the quarterly transfer reports to NRC. The proposed rule is intended to ensur,e that general Itcensees are aware of and understand the-V requirements @tendantt he possession of devices containing byproduct'

/- m 1

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( Enclos }ure E b ___

E__-- - e .- -m.. 6. - - . - + .3 _ *. .A, c. e + se v - - - . ,w,h p-n.-- ,he-r 19 -w , , . - . -

material. This awareness will better assure that general licensees will comply with the requirements for proper handling and disposal of generally licensed devices and presumably reduce the potential for incidents that could result in unnecessary radiation eFp0sure to the public. . . . .

DA1E: The comment period expires 75 days after publication. Comments received after this date will be considered if it is practicable to do so, but the NRC is able to ensure consideration only for comments received on or before this date.

ADDRESSES: Mail written comments to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.

DelivercommenIstoOneWhiteFlintNorth,11555RockvillePike,Rockville, MD, between 7:30 as and 4:15 pm on weekdays. Copies of the draft regulatory analysis, as well as copies of the connents received on the proposed rule, may be examined at the NRC Public Document Room 2120 L Street NW. (Lower Level),

Washington, DC.

FOR FURTHER INFORMATION CONTACT

Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555, telephone (301) 492-3795.

i 2 Enclosure

. - . _ . .. - = . _-. _ - - _ . . --

SUPPLEMENTARY INFORMATION:

Background

On February 12,1959 (24 FR 1089), the Atomic Energy Comission amended its regulations to provide a general license for the use of byproduct material contained in-certain luminous, measuring, gauging, and controlling devices.

etW uns my gigsifshe of Under the current (concittogp forga general license, certain persons may

/

receive and use a device containing byproduct material if the device has been manufactured and distributed in accordance with the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific pu s o Itcense is issued3upon a determination by a regulatory authority that the v a

safety features of the device and the instructions fr= safe operation are adequate and meet regulatory requirements. The general licensee is required to comply with the safety instructions contained in or referenced on the label of the device and to have the testing or servicing of the device performed by an individual authorized to manufacture, install, or service these devices. A generally licensed device is a " black box," that is, the radioactive material is contained in a sealed source usually within a shielded device. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. Thus 3the general license V policy is a mechanism to simplify the lidense process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary.

3 Enclosure

- - . - _ ~ . - . . -. - - - _

Discussion-There are about 600,000 devices contain yproduct material in.use by Y about 35,000 licensees under the txxission's general license regulatory 1

e program. -General licensees have not been contacted by NRc on a regular basis j because of the relatively small radiation risk posed by generally licensed l devices. These devices have survived fires and explosions on many occasions  !

without a total loss of shielding. They have been damaged by molten steel,  ;

and hit by construction vehicles with only minor losses in radiation shielding. j while maintaining the integrity of the source capsule. , cwyn; g; sc.

Nonetheless, there have been a number of occurrences where 4 radioactive I material Wnot been properly handled or disposed of sult h n radiation V  !

exposure of the pubite. Although no significant public health and safety hazards resulted from these incidents, oper handling and disposal [

w o- 7

- proceduresg been followed, these avoidable exposures would not have occurred.

For example, one or more cesium-type gauges were mixed in with some scrap metal that was melted down to form steel and the entire batch of steel was

. contaminated, in another instance, a static eliminator bar with 22.5 millicuries of americium-241 was-sent to a sanitary landfill over which the i

. NRC has no jurisdiction. There have.been other types of incidents involving NRC generally-licensed devices including damaged devices, leaking or contaminated sources, and equipment malfunctions. However, loss of

accountability, asl occurred above, remains the most frequent incident and the predominant concern.

Because of these occurrences, the NRC's.0ffice of Nuclear Material Safety _

and' Safeguards (NMSS) conducted a radiological: risk ~ assessment addressing.

_4 Enclosure .

+

_ =

1

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storage of devices in warehouses, disposal in scrap yards, incineration of waste, molting in a smelter, and disposal in a landfill, geluded in the risk V assessment n incident at a steel company in 1983 (discussed in NUREG- /

1188, "The Anhorn W C Company Radioactive Contamination incident") that probably represents a worst-case scenario for generally licensed gauging ttucu e t 0 v-V devices. Although individual doses were low and within(aforementioned) limits for exposure of members of the public, they nevertheless represent unnecessary additional public exposure that could have been avoided. in addition, the cleanup costs were in excess of four million dollars with additional costs incurred for the staff efforts of regulatory agencies, in consideration of both the risk assessment and incidents like those noted above, the NRC conducted a three-year sampling (1984 thru 1986) of general licenIees (taken from the vendors' quarterly reports) to determine whether there was an accounting problem with gauge users under general licenses, and if so, what remedial action might be necessary. The sampling was conducted both by telephone calls and site visits. The sampling revealed gc.a6 ee /

several areas of concernMhe use of radioactive material under the general license provisions. On the basis of the sampling, the NRC concluded ass t '

that there is (1) a lack of awareness of appropriate regulations on the part of the user (general licensee) and (2) inadequate handling and accounting for these generally licensed devices. The NRC further concluded that these two problems could be remedied by more freqtient and timely contact between the general licensee and the NRC. This conclusion by the NRC provides the basis-for the regulatory changes propcsed in this acti The r e would be a f

m'l ter of compal ility for the reement Statesh The Agreemen .tates velopment of t s rule. Cop of the propose quie Lparticgatedinthe 5 Enclosure

$ng 1NSY.RT fA

4

,h Insert A, page 5 ,

l An estimated 70,000 Agreement State licensees uso the types of l sources devices covered by the amendments being proposed '#

i RC's general licensees. consequently, the Sthtes will I

today to play an- aportant role in achieving improved regulatory oversight on a national basis. Many of the States already have

~

. . sreennt* bili &.y programs in place. The Agreement states participated in the development of this rule and indicated l agreement with the concept of tha proposed rule. Specific-comments.from th greement states were adopted except for L' suggestions that C charge general licensees fees and that there is no need-for a standard format for submitting information. The '

fee issue'will be addressed separately. The proposed rule provides flexibility in the use of the standard format."

The commission is considering ing the amendmentg a matter of L' compatibility for the states. c staff has suggested that the amendments be categorized as vision 2 level-of compatibility. ,

This level of compatibility requires that states address provisions in NRC regulations relating to basic principles of radiation safety and regulatory functions without necessarily using identical language. Stata= may also adopt requirements more restrictive-than NRC rules under this level of y-compatibili$y. The yAE would appreciate comments on this suggestion. g .,g., y h

I m

5

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xwerecirculatedtokheAgreementStates. The have supported the rulemaking h d all of their comm s were considered and in rporated as appropriate.

5

\ The risk assessmentind the sampling above als led the Comission to conclude that for a small g up (a few hundred) of gen ally licensed gama }

gauges radiation risk, tho h small in an absolute s e, may be sufficient o warrant their conve ton to specific licenses. In adoition, there also ap .ars to be another, la er group of generally lic nsed devices (about10,000) ere the radiation ris is estimated to be very 1 . These vices, e.g., bet backscatter gauges an analytical devices may be can dates for exemp on from further regul ion under the Comission' BRC Policy. The Comission is considering these a tons. This proposed l regulatio addresses the st majority of general licensed devices that f 1 l 4

in the midd of the risk sp trum. For these e evic s, the risk is small to the extent tha specific licens g can not 'se justifie But neither is it so small, especially in consideration of the very large numb s of such devices k

extangthatexempt ns would appear o be appropriate, An estimated 35,000 persons use certain measuring, gauging, or et y controllingdevicesunder%c.'.sA general license. NRC regulations that affect these general licensees' responsibilities and that are presently being amended are 10 CFR 31.2, 31.4, 31.5, and 31.6. Under 10 CFR 31.2, " Terms and Conditions," all general licensees are subject to certain provisions of Part 30 and also Parts 19, 20, and 21. The proposed revision to E 31.2 would also subject all general licensees to the requirements of 10 CFR 30.9,

" Completeness and Accuracy of Information," which imposes certain requirements he.

regarding the completeness and accuracy of the information submitted to NRC by u licensees not now irposed upon general licensees.

6 Enclosure

e Section 31.4 of 10 CFR Part 31, "Information Collection Requirements:

OMB approval,* lists the various sections of Part 31 that contain approved information collection requirements. Paragraph (b)f501.4isbeingamended t/

to add i 31.6 to the approved listing.

Section 31.5, "Certain meuuring, gauging or controlling devices," l l

provides for a general licensee to acqJire, receive, possess, use, or transfer  ;

1 byproduct materials. It also specifies the responsibilities of general j licensees regarding the use of byproduct materials. Under the proposed revisions,a new paragraph (c)(ll) would be added to require the general licensee to provide specific information to the NRC upon request. This information would include the complete name and address; specific information about the device, such as manufacturer, model number, and number of devices; name, title, aid telephone number of the person responsible for controlling the use of the device; the address where the device is located or used; and whether the specific requirements of paragraph (c) of 5 31.5 have been met.

In addition, a proposed revision to paragraph (b) of 5 31.5 would delete all references to specific licenses issued by Agreement States that authorize distribution of devices to persons generally licensed by Agreement States, y osto At present, 10 CFR 31.6, ' General license to install devices generally licensed in 5 31.5,* provides a general license to certain specific licensees from Agreement States to 'nstall or service devices used under i 31.5. The current regulation, 10 CrA 31.6, is not clear with respect to time goofR F restrictions, giragrapiJl>0.20(b)(3)6f10CFRPart150)imposesa180-day- V per-calendar-year limitation on the activities of Agreement State Licensees in non-Agreement States. The proposed amendments to S 31.6 would remove this restriction for i 31.5 licensees. This change will be convenient to the NRC, 7 Enclosure

__ _ _ . - . . _ . . . - _ . . .. m . . . _. _ _ .- _ .. ___.__ _ _ __ _._ _ _ _ _ _

-o Insert B, page 7 * ,

I The registration and verification system contained in the '

' proposed amendments to 10 CFR Parts 31 and 32 will include all general licensees, including those who previously acquired radioactive sources. If older sources are transferred, they would be subject to the same requirements as newcr sources and the registration system is intended to capture them. General licensee transfers of sources are limited to either transfer to specific licensees or other general licensees by the existing In both cases, provisions of 10 CFR- .5(c) (8) and (9) . "

licensees must notif artC32 of the transfers. If the specific or Agreement State equivalent licensee is a 10 CPR distributor, the reporting requirements of the proposed rule

'would apply to any subsequent transfers. The current NRC data '

J . base, although limited, includes identification 94Ggeneral '#

licenseeswhoacquiredgauges'asearlyas1959.I1ce,CstAffplans to contact these licensees and any new general nsee as part of the enhanced oversight effort.

4 4

- - - - __ = _ _

-n ,- + .....nn,-- v-. --.- -.- , - + + -- - -- -

Agreement States, and manufacturers because it will reduce and simplify paper work without increasing the risk to public health and safety, oposed M

% rep 31.6 (a) would require the general licensee holding a specific license v' from an Agreement State to report to the NRC all persons receiving a device from tiie licensee, as specified in the accompanying proposed revision to y t wt i 32.52. Proposed Garacraof0 31.6 (d) would require at licensee to supply V 3

each of the recipients of a generally licensed device a copy of the general license contained in 5 31.5. ProposedQIaagrat@31.6(e)wouldrequirethat ,

written instructions and precautions be provided to persons servicing a F f "

generally licensed device. Proposed (JaragrapR)31.6 (f) would also require a person performing routine installation / servicing / relocation of these devices to notify the appropriate NRC regional office at 1 cast 3 working days prior to thestartoftheactivities. This notification would allow for a level of periodic inspection of those activities that intentionally place a worker in direct contact with the device or an unshielded radiation source. It is not intended that the prior notification requirement apply in cases where a radiological hazard due to an accident or a malfunction of the device exists.

To be consistent with the proposed modifications, the section heading would be amended to read ' General license to distribute, install, and service devices generally licensed in 5 31.5."

s W '. V 10 CFR 32.51a, ' Conditions of licenses," presently imposes conditions on applicati for a specific license to manufacture or initially transfer V generally licensed devices to general licensefs. The addition of proposed paragraph (c) to $ 32.51a would require such specific licensees to provide recipient users of generally licensed devices with written instructions and precautions to ensure that the devices are used safely. In addition, these 8 Enclosure

- - - _ _ - _ _ _ _ _ _ _ - . - - _ _ _ _ -__-__.-._.--______-a__--.____------____________u__ _ ~ _ _ _ , _ _ _ . _ _ _ _ _ _ _ , _ , _ _ _ _ _ _ _ , _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

_ _m __

e specific licensees would be required to provide those users with information regarding testing requirements, transfer and reporting requirements, and disposal options for the devices being transferred.

10 CFR 32.52, 'Naterial transfer reports and records," currently requires . , .

specific licensees authortred to distribute devices to general licensees to file transfer reports with the NRC on a quarterly basis. The revised regulation would prescribe the format to be used when submitting transfer reports to the NRC. Theproposedforma5 ovide more detailed and complete information about the general licensee to whom the device is transferred. The format is presented in proposed Subpart Egf l'r t 9 7 5 32.310. Licensees who do not use the prescribed format would be permitted to provide all of the information required by the format on a clear and legi-ble record. Inaddition,specificlicenseeswouldberequiredtoidentifya person responsible for meeting the requirements associated with the possession of the generally licensed device rather than simply identifying a point of contact at the general itcensee's location.

After receipt of the quarterly transfer reports from the specific licensee under 5 32.52, the NRC would send letters to the general licensees who received the devices during the preceding reporting perio hem to verify in writing that they had purchased the devices containing byproduct material and that they understand the requirements of the general license.

The general licensee under proposed 5 3f.5(c)(ll)(ii) would be required to respond to the NRC by letter and to verify safety-related information about the device and its location. Thereafter, notices would be sent periodically to the general licensees requesting that they verify that they still have the

' device, verify the safety-related information, and remind them of their 9 Enclosure

I l

l i

i j

regulatory responsibilities in using the device. The frequency of these l, letters may range from 1 to 3 years. Any failure to respond or any reports of l lost devices would initiate NRC follow-up action. This contact between the i NRC and the general licensee would allow the NRC to validate. and v,ndate Jhe f information currently contained in the data base that the NRC maintains for  ;

its general Ilconsees.

Although these proposed requirements would impose additional costs on -

t

,_ - licensees -the Consission has estimated these to be nominal (on the order of -

510 per device). Accordingly, the Commission believes that the increased i i

compliance by general licensees'and confidence in the appropriateness of the 1

general license program potentially afforded by these new requirement. l eutweigh this cost. Nonetheless, the Commission particularly requests

commentsonthismatter.

At the time cf the final rulemaking on this matter, the Commission  ;

intends to provide for an interim enforcement policy to supplement the current i 1

Enforcement Policy in 10 CFR Part 2, Appendix C, to address violations arising  ;

from the proposed regulations. The interim policy would remain in effect for one cycle of the notice and response program, approximately three years.

Under the existing NRC Enforcement Policy significant violations such as those ' V 3

involving lost sources may result in escalated action including civil penalties. The interim policy would' provide that in the initial phase of the'  ;

implementation of; a notice and response program, enforcement action would not normally be'taken for violations identified by a licensee in submitting

-information pursuant to the proposed' regulation provided. appropriate i

corrective action is initiated. This change from the Commission's normal enforcement policy-in 10 CFR Part 2. Appendix C, is to remove any disincentive .

10 Enclosure ,

[ '4'-'y'9' W t-'9r=WST ?"P W T-PMP -f*M=%w++d- -V+W 'sm-gP h&-'- r up-'e-Fsyt*'-Mc 5?y> 491 p'-+e*"=P' -#-wwt e

t 1

o i

i  :

to identify deficiencies caused by a concern of potential enforcement action.  !

This-action would be taken to encourage general-licensees to search their 4

facilities to assure sources are located, to determine if appitcable requirements have been met, and to develop appropriate corrective action when deiiciencies are found. However, enforcement action will be considered for  ;

violations involving the failure to provide the infomation requested or take r appropriate corrective actions or willful violations including the submittal i 4

f of false information. Sanctions in those situations _may_ include civil-penalties as well as orders to limit or revoke the authority to possess- l radioactive sources under a general license.

Environmental Impact: Categorical Exclusion

[' 4 1

The NRC has determined that the proposed regulations are the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii).

Therefore, neither an environmental impact statement nor an environmental

, assessment has been prepared for this proposed regulation.

1 Paperwork Reduction Act Statement The proposed rule amends'the information-collection requirements that are subject to the Paperwork Reduction ActIof 1980 (44 U.S.C. 3501 et seq.). This proposed rule has_been submitted to the Office of Management and Budget for d I review and approval of the paperwork requirements.

The public reporting burden for this collection of infomation:is estimated to average about 20 minutes per response, including time for-11 Enclosure 3-

~ _ _.

- e + . 5 r e e s m 's.-- . c w a, . m . e-- w e e -- e -e,+-m-wu-w.w - r ew ww - %w,4-- e- v-- m .wa 4.---w-,e.rww.-r--, ns-n---*%w-e-r-.r--m-w.w.ww--.,-e w w -- e w-

j  !

P r

reviewing instructions, searching existing data sources, gathering and j maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including sugoestions for reducing this burden, to the Information and Records Management Branch (MN88-7714), U.S.

Nuclear Regulatory Commission. Washington, DC 20555, and to the Desk Officer, Office of Information and Regulatory Affairs, NE08-3019 (3150-0016 and 3150-0001), Office of Management and Budget, Washington, DC 20503. , .

Regulatory Analysis The NRC has prepared a draft regulatory analysis of this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

Single copies of the draft analysis may be obtained from Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, ,

Washington,.DC 20555, telephone: 301-492-3795.

Regulatory Flexibility Certification 1

Based on information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act 5 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic impact on a substantial number of small entities. The NRC has adopted size standards that classify a small entity as one whose gross annual 12 Enclosure

receipts do not exceed $3.5 million over a 3-year period. The proposed rule affects about 35,000 persons using products under this general license, many of whom would be classified as a small entity. However, tha NRC believes that the economic impact of the proposed. requirements on any general licensee would be negligible. The proposed rule is being issueu to better ensure that the general licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.

Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to these proposed rules and therefore a backfit analysis is not required becausethese$roposedamendmentsdonotinvolveanyprovisionsthatwould impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Parts 31 and 32 4

10 CFR Part 31 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment, t 13 Enclosure

. - - - - - , - . - - =. - .-

t j ...

10 CFR Part 32 ,

byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation nrnt.ection, Reporting and recordkeeping requirements, and Scientific equipment.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 31 and 32 PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT HATERIAL

1. 1he Iuthority citation for Part 31 is revised to read as follows:

Authority: Secs. 81,161,183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended. 207, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5847).

Section 31.6 also issued under sec. 274, 73 Stat 688 (42 U.S.C. 2021).

For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);

SS31.5(c)(1)-(3)and(5)-(9),31.6,31.8(c),31.10(b),and31.ll(b),(c),and (d) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b);

and 5531.5 (c)(4), (5), (8), and (11), 31.6 (d)-(f), and 31.ll(b) and (e) are issued under sec. 1610, 68 Stat. 950, as' amended (42 U.S.C. 2201(o)).

2. Section 31.2 is revised to read as follows: S 31.2 Terms and c

conditions.

14 Enclosure

e

.e.

The general Itcenses provided in this part are subject to the p,rovisina of ss 30.9, 30.14(d), 30.34(a) to (e), 30,41, 30.51 to 30.63, and Parts lf 20, and 21 of this chapter' unless indicated otherwise in the language of the general license.

3. In s 31.4 paragraph (b) is revised to read as follows s 31.4 V' liEformationc.ollectionrequirewnts: OMB approval.

(b) The approved information collection requirements contained in this part appear in $5 31.5, 31.6, 31.8, and 31.11. y 9

4 4 4

4. In s 31.5, paragraph (b) is revised and paragraph (c)(ll) is added to readasfolloA s 31.5 Certain measuring, gauging, or controlling devices.' V (b) The general Itcense in paragraph (a) of this section applies only to byproduct material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued pursuant to S 32.51 of this chapter or in accordance with the specifications contained in the general license of 5 31.6.

(c) * *

• Y l

' Attention is directed particularly to the provisions of the regulations in Part 20 of this chapter that relate to the labeling of containers.

' Persons possessing byproduct material in devices under a general license

.in 5 31.5 before January 15, 1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of 5 31.5 in'effect on January 14, 1975.

15 Enclosure

. - . ,,.w..a _..m,, w .-. ., - - . - - - - , - , _ . ,- .

~ - -

1 i .

(11) Shall respond within 30 calendar days of receipt of a request from the Nuclear Regulatory Comission to verify the following information and any other such information as may be requested by the Commission as it relates to the general license. Further, the general licensee shall notify the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington D.C. 20555 within 30 calendar days if any of the requested information should change.

(i) Name and complete address of the general licensee.

(ii) Identification of specific information about the device, such as:

the manufacturer, model number, the number of devices, type of isotope, and who has performed what service on the device since the last report concerning the device was submitted to the NRC, (iii) Nade, title, and telephone number of the person who is responsible for the device and for ensuring compliance with the appropriate regulations and requirements.

(iv) Address at which the device is located or used. j (v) Whether the requirements of S 31.5(c)(1) through 1.5 c)(10) have been met, g g j

5. Section 31.6 is amended by revising the section heading and the introductory paragraph and by adding paragraphs (a), (d), (e), and (f) to read as follows: I S 31.6 General license to distribute, install, and service devices generally licent in S 31.5.

t.ny person s , holds a specific license issued by an Agreement State authorizing the holder to manufacture, distribute, install, or service devices 16 Enclosure

described in S 31.5 within the Agreement State is hereby granted a general license to distribute, install, or service the devices in any non-Agreement State for an unlimited period of time and a general license to distribute, install, or service the devices in offshore waters, as defined in S 150.3(f),

provided that:

(a) The Agreement State licensee files the appropriatt transfer reports as required by paragraphs (a) and (b) of S 32.52.

/

[ * *

(d) The person shall furnish a copy of the general license co'ntained in S 31.5 of this chapter to each person who is responsible for the byproduct material and for ensuring compliance with the appropriate regulations and requirements.

(e) The4 person shall provide the individual responsible for service of tro dt.vice with written instructions and precautions necessary to ensure its safe installation, operation, and service. These instructions shall include leak-testing requirements, transfer and reporting requirements, disposal options, including possible costs and reporting requirements for lost or damaged devices.

(f) The person performing routine service / installation or relocation of devices shall notify the appropriate NRC Regional Office listed in Appendix 0 of Part 20 of this chapter at least 3 working days prior to engaging in such activities in Non-Agreement States. Theenotification shall include the date and location of the activity that will be performed. Prior notification does not apply in cases where a radiolegical hazard due to an accident or malfunction of the device exists.

l Enclosure 17

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

6. The authority citation for Part 32 continues to read as follows:

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);

SS 32.13, 32.15 (a), (c), and (d), 32.19, 32.25 (a) and (b), 32.29 (a) and (b), 32.54, 32.55 (a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201 (b)); and SS 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52, 32.56 and 32.210 are issued un8er sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

7. Section 32.51a is amended by adding paragraph (c) to read as follows:

6:-- S 32.51a Same: Conditions of licenses. -

(c) Furnish the individuals identified under S 31.5(c)(ll) or 531.6(d) with written instructions and precautions necessary to ensure safe installation, operation, and service of the device. These instructions must include the leak-testing requirements, transfer and reporting requirements, disposal options including possible costs, and reporting requirements for lost or damaged devices.

8. Section 32.52 is revised to read as follows:

6- S 32.52 Same: Material transfer reports and records. V 18 Enclosure i

Each person licensed under S 32.51 or S 31.6 to initially transfer devices to generally licensed persons shall:

(a) Report quarterly to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Comission, Washington, DC 20555, and send a copy of the report to the appropriate NRC reg lonal office listed in Appendix 0 of Part 20 of this chapter all transfers of such devices to persons for use under the general license in S 31.5 of this chapter. The report must be provided either in the format presented in Subpart E,ef P:rt Y

W J

-427 5 32.310. " Transfer Report Format," or on a clear and legible . record as long as all of the data required by the format is included. If one or more intermediate persons temporarily possesses the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediary as in Subpart E, S 32.310, and clearly designate that person as an intermediary. If no transfers have been made to persons generally licensed under S 31.5 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter.

(b) Report quarterly to the responsible Agreement State agency all transfers of such devices to persons for use under a general license in an Agreement State's regulations that are equivalent to S 31.5 The report must be provided either in the format in Subpart E, S 32.310, " Transfer Report Format," or on a clear and legible record as long as all of the data required by the format is included. If one or more intermediate persons temporarily possesses the device at the intended place of use prior to its possession by the user, the report must include the same information for each intermediary

' as in Subpart E, S 32.310, and clearly designate that person as an 19 Enclosure

inte rmediary, if no transfers have been made to persons generally licensed under S 31.5 during the reporting period, the report must so indicate. The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter.

(c) Keep records of all transfers of such devices for each general licensee and in compliance with the above reporting requirements of S 32.52.

Records required by this section must be maintained for a period of 5 years from the date of the recorded event.

9. SubpartE)Sction32.310fsaddedto10CFRPart32toreadas V/

follows:

cd ~'Subpart t - Report of Transfer of Byproduct Materials l'

/

S S 32.310 Transfer Report Format.

This section contains the format required by S 32.52.

20 Enclosure

a

, Subpart E-Report of Transfer of Byproduct Materials Section 32.310 - Transfer Report Format -

NAME OF VENDOR AND LIC NSE NUMBER REPORTING PERIOD FROM TO GENERAL LICENSEE INFORMATION COMPANY NAME, STREET, CITY, DEPARTMENT STATE, ZIP CODE PERSON RESPONSIBLE FOR CONTROL OF THE DEVICE f4AME AND6 TITLE TELEPHONE t"JMBER FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY AND UNITS NUMBER NUMBER e

I

Subject:

Requirements for the Possession of Industrial Devices Containing Byproduct Material (RIN 3150-AD34).

Dated at Rockville, Maryland this day of 1991.

For the Nuclear Regulatory Commission, ilames H. Taylor Executive Director j -

j T for Operatio .

4 I

22 Enclosure

44 W G

ENCLOSURE 4 4

i I

[pm prog o, UNITED STATES y

(j NUCLEAR REGULATORY COMMISSION WASHINGTON. D. C. 20555

%,*..../

The Honorable Peter H. Kostmayer, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs ~~

United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the subcc:;aittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is proposing to amend these regulations to require the general licensees to provide the NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material.

Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training The general licensee is required to comply with the safety orexperience.fovidedandtohaveallservicingdonebypersonswith instructions p appropriate experience who are licensed to perform the service. In order to evaluate the effectiveness of the general license program, we have conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Through thr:e actions, the NRC will be able to provide greater assurance that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Notice of Proposed Rul'emaking cc: The Honorable John J. Rhodes i

'o UNITED STATES

1. f g

! o NUCLEAR REGULATORY COMMISSION

{ I W ASHINGTON, D. C. 20$55 The Honorable Bob Graham, 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 Reoister. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is pro)osing to amend these regulations to require the general licensees to provide tie NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material.

Generally licensed-devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience.. The general licensee is required to comply with the safety instructions provided and to have all servicing done by persons with appropriate experience who are licensed to perform the service. In order to evaluate the effectiveness of the general license program, we have conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply wi; the requirements attendant to the possession of the devices. Through these actions, the NRC will be able to provide greater assurance that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Notice of Proposed Rulemaking cc: The Honorable Alan K. Simpson

s '

[ p ue o g UNITED STATES y g NUCLE AR REGULATORY COMMISSION n W ASHING T ON, D. C, 205$5 l

\..../ ,

The Honorable Philip R. Sharp, Chairman Subcommittee on Energy and Power Committee on Enercy and Commerce United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the subcommittee is a copy of a Notice of Proposed Rulemaking to be putlished in the Federal Reoister. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is proposing to amend these regulations to require the general licent.ees to provide the NRC with specific information about the licensed devicas. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material.

Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience. The general licensee is required to comply with the safety instructions provided and to hate all servicing done by persons with appropriate experience who are licensed to perform the service. In order to evaluate the effectiveness of the general license program, we have conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lack of knowledge of the regulatory requirements associated with the devices, The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Through these actions, the NRC will be able to provide greater assurance that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Notice of Proposed Rulemaking cc: The Honorable Carlos J. Moorhead

The Honorable Peter H. Kostmayer, Chairman . IDENTICAL LETTERS T0:

Subcommittee on Energy and the "nvironment The Hon. Bob Graham, Chairman Committee on Interior and Insular Affairs Sub, on Environment & Public Works United States House of Representatives cc: flan K. Simpson Washington, DC 20515 The Hon. Philip R. Sharp, Chairman Sub. on Energy and Power cc: Rep. Carlos J. Moorhead

Dear Mr. Chairman:

Enc 19 sed for the information of the subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is proposing to amend these regulations to require the general licensees to provide the NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material.

Generally licensed devices are designed with inherent radiation safety features so that the devices can be used by persons with no radiation training or experience. The general licensee is required to comply with the safety instructions provided and to have all servicing done by persons with appropriate experience who are licensed to perform the service. In order to evaluate the effectiveness of the general license program, we have conducted surveys of the users of the devices. Our surveys have indicated that, for a higher percentage of the licensees than we would like, there is inadequate accounting for the devices and a lac ( of knowledge of the regulatory requirements associated with the devices. The proposed rule is intended to enhance our regulatory oversight of the general licensees and to ensure that general licensees are aware of and comply with the requirements attendant to the possession of the devices. Throagh these actions, the NRC will be able to provide greater assurance that generally licensed devices are properly handled and disposed, thereby reducing the potential for unnecessary radiation exposure to the public.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Notice of Proposed Rulemaking cc: The Honorable John J. Rhodes

• SEE PREVIOUS CONCURRENCE Offc: RDB:DRA:RES RDB:DRA:RES RDB:DRA:RES DD:DRA:RES D:DRA:RES DD/GIR:RES D:RES Name: *JMate:jb *MFleishman *SBahadur *FCostanzi *BMorris *CHeltemes *EBeckjord Date: 5/23/90 5/23/90 5/30/90 5/30/90 5/30/90 6/1 /90 7/ /91 Offe: EDO OCA Name: JTaylor DRathbun Date: 7/ /91 7/ /91 0FFICIAL RECORD COPY

/

i IDENTICAL LETTERS ,TO: ~

Chairman Bob Gra am, Senate Subcomittee o Nuclear Regulation ec: Alan Simpsor.

Chairman Ph) ip R. Sharp, House Subcomittee on Energy and. Power cc: C ilos J. Moorhead The Honorable Morris K. Udall, Chairman Subcomittee on Energy and the Environment / t

/

Comittee on Interior and Insular Affairs United States House of Representatives '

/

Washington, DC 20515 /

Dear Mr. Chairman:

Enclosed for the information of the subcondittee is a copy 10 CFR of aPartNotice 31 of Proposed Rulemaking to be published in t)(e Federal Reg contained in certain devices. The NR rovide the NRC with specific information to require the general licensees to onding changes would also be made in 10 CFR about the licensed devices. Corre Part 32 on the transfer reporting equirements imposed on persons authorized to distribute byproduct material. Jhese changes are being m of awareness of the appropria,te regulations on the part of general licensees.

It is anticipated that thedroposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC.

Sincerely, Eric S. Beckjord, Director  !

Office of Huclear Regulatory Research

Enclosure:

/

Notice of/ Proposed Rulemaking

• See previous copy for concurrence.

cc: Ryp/

resentative James V. Hansen D:R RDB:DRA* DD:DRA* 0:DRA*

OFF E:RDB:DRA:* RDB:DRA* temes EBec ord H  : JMate MFleishman SBahadur FCostanzi BMorris(6 /90 6///90 1

5/30/90 5/30/90 E: 5/23/90 5/23/90 5/30/90 FFICE: EDO OCA NAME: JTaylor DRathbun DATE 5/ /90 / /90 0FFICIAL RECORD COPY

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t4(pcg* 3 IDENTICAL LETTERS -TO:

Senate Chairman John B. Brea SubcommitWeTn uc ear Regulation cc: A16n K. Simpson Chairman' Philip R. Sharp House Sabcomittee on Energy and Power cc:' Carlos J. Moorhead The Honorable Morris K. Udall, Chairman Subcomittee on Energy and the Environment .

Comittee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the su comittee is a10copy of a31Notice of CFR Part Proposed Rulemaking to be published in the Federal Register.

establishet general licenses for the' possession and use of byprodu contained in certain devices.

torequirethegenerallicenseesgoprovidetheNRCwithspecificinform about the licensed devices.

part 32 on the transfer reportirig requirements imposed on persons authoriz distribute byproduct material / These changes are being made because there inadequate accounting for generally licensed devices, and also a general ofawarenessoftheappropr)fiteregulationsonthepartofgenerallicensees.

It is anticipated that the/proposed rules will ensure that these two problems are remedied by more timdly contact between the general licensee and the N Sincerely, Eric S. Beckjord, Director Office of Nuclear Regulatory Research

Enclosure:

Notice of Proposed Rulemaking cc: g tive James V. Hansen DD:DRA D RA DD:GIR D:RES OFFICE:RY:0RA: RDP. F dur Ff/Aalizi ris CHeltemes EBeckjord NAME: JRate MFTeithman SBa 5/ /90 5/ /90 DATE: 5/a3/90 5/23/90 5/Jo/90 5/![F/90 /J/%/90 I 0FFICE: EDO HAME: JTaylor DATE 5/ /90 0FFICIAt RECORD COPY

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Distribution: [ CONGRESS.LET)

Subj-circ-chron Reading files DRathbun JTaylor

• RBernero RCunnin5 ham EBeckjord CHeltemes BMorris FCostanzi SBahadur MFleishman JHate 4

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ENCLOSURE 5 4

NRC PROPOSES AMENDMENTS TO REGULATIONS GOVERN 11.J POSSESSION OF INDUSTRIAL DEVICES The Nuclear Regulatory Commission is proposing amendments to its regulations governing the possession of industrial devices . . .

which contain radioactive materials.

As proposed, the amendments would require, among other things: .

--General licensees to supply the NRC information on the identification of devices in their possession and the persons responsible for them; and

--Specific licenseos, who are distributors of generally-licenotd devices, to use a uniform format when submitting quarterly transfer reports to the NRC.

The proposed amendments are designed to provide further assurance that general licensees are aware of and understand the requirements for the possession of devices containing radioactive materials and that they will comply with the requirements for proper handling at;d disposal of these devices.

About 35,000 general licensees use some 600,000 devices under the NRC's program which permits them to receive and use a device containing radioactive material. These devices must be manufactured and distributed in accordance with the specifications contained in a specific license issued either by l

T _ - _ _ _ - - _ - - - _ __ _ __ _ ____

b the NRC or one of 28 Agreement States (States which, by agreement, have assumed part of the NRC's regulatory authority).

An addditional 70,000 licensees use these devices under a general license issued by Agreement States.

A specific license is issued based on a demonstration to a regulatory authority that the safety features of the device and instructions for its safe operation are adequate and meet regulatory requirements.

A general licensco is required to comply with the safety instructions contained in or referenced on the device label and to have the testing or servicing of the device performed by an individual atethorized to manufacture, install or service it.

In a generally-licensed device, the radioactive material is contained in a sealed source usually within a shielded device.

In the past, however, there have been a number of incidents where those devices have not been properly handled or disposed of and the incidents resulted in radiation exposures to members of the public. Although there have been no significant public health and safety hazards resulting from these incidents, the radiation exposures to members of the public could have been avoided if proper handling and disposal procedures had been followed.

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As proposed, the amendments are expected to better assure that general licensees follow proper procedures and presumably reduce the potential for incidents lea' ding to avoidable radiation exposures to members of the public.

The Commission also is considering making the proposed amendments a matter of compatibility for Agreement States--in other words, Agreement States would be required to have similar, but may have more restrictive, requirements for their licensees.

Written comments on the proposed amendments to Parts 31 and 32 of the Commission's regulations should be received by (date).

They should be addresnod to the Secretary of the Commission, Nuclear Regulatory Commission, Washington, D.C. 20555, Attention: Docketing and Service Branch.

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4 4

ENCLOSURE 6 6

'ARGONNE NATIONAL LABORATORY 9700 South Cass Avenue, Argonne, Illinois 60439

- DRAFT Rr.GULATORY ANALYSIS:

REQUIREMENTS FOR POSSESSION OF DEVICES CONTAINING BYPRODUCT MAIERIAL by a

Philip H. Kier Environmental Assessments and Information Sciences Division and Joseph J. Mate U.S. Nuclear Regulatory Commission June 1991 1

work sponsored by lu.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Regulatory Research-

CONTENTS A B ST RA CT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 STATEMENT OF THE PR0BLEM...............................................

1.1 Background.........................................................

1.2 NRC Study of Conformity with General License Conditions. .. . . . . .. ...

1.2.1 Part 1 Results............................................... '

1.2.2 Part 11 Results..............................................

2 0BJECTIVES.............................................................

3 ALTERNATIVES...........................................................

3.1 No Change....................................................'......

3. 2 Mod i fy Reporti ng Requi rement s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.2.1 Knowledge of Conditions in General Licenses. . . . . . . . . . . . . . . . . .

3.2.2 Verification of Conformity with General License Conditions...

4 CONSEQUENCES...........................................................

4.1 Bene fits 6of Al ternative 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.2 Costs of Alternative 2.............................................

4.2.1 Costs of Revisions to 10 CFR 31.5............................

4.2.2 Costs of Revisions to 10 CFR 31.6............................

4.2.3 NRC Development and Implementation Costs.....................

4.2.4 Summary of Costs.............................................

5 DECISION RATI0NAli.....................................................

6 IMPLEMENTATION.........................................................

7 EFFEC 1 ON SHALL ENTITIES...............................................

TABLES 1 - Types of Costs Likely to be Avoided by the Proposed Revision. . . . . . . . .. .

2 Summary of Costs to NRC and Industry of Proposed Changes...............

111

ABSTRACT A survey of holders of general licenses issued by the U.S. Nuclear Regulatory Commission for possession and use of certain devices containing byproduct material was conducted in response to several instances of record where devices were improperly maintained, improperly transferred, or inadvertently discarded. The survey indicated that general licensees are frequently unaware that there are c rtain license conditions that must be complied with relating to the possession and use of these devices, t.ack of compliance with general license conditions has led to improper disposal of some devices, and in some cases, has resulted in exposure of the public to radioactive material. Although the NRC knows of no instance where exposure has caused significant public health and safety hazards, had proper handling and disposal procedures been followed, these exposures would not have otherwise occursed. Moreover, costs ranging from $50,000 to $2,000,000 have been incurred in cleanup and disposal of contamination resulting from incidents of improper disposal, with additional costs incurred for the staff efforts of regulatory agencies.

The staff is proposing to revise certain regulations contained in 10 CFR Parts 31 and 32, to ensure the general licensees' understanding of the regulations and hence better assure their compliance with general license requirements. The revisions would require that a manufacturer, with a specific license from an Agreement State, provide a copy of the NRC general license to each person to whom a device containing byproduct material is transferred in lieu of the alternative presently provided for in some Agreement State regulations equilavent to 10 CFR 32.51a(b) . Such a requirement already exists, under 10 CFR 32.51a, for a specific licensee from IV

P a non-Agreement State. The revisions would also require general licensees to verify their compliance with the general license requirements upon NRC request soon after receiving the devices and periodically thereafter.

The Commission has an obligation to take reasonable steps to help ensure compliance with its regulations when noncompliance increases the risk of exposure to radiation. A regula+ory analysis of the costs and benefits of the proposed revisions has been completed. Costs to be borne by the Commission for the proposed revisions were estimated as follows: $63,000 for development / implementation and $67,000 for annual operations. The annual industry operations costs were estimated to be'5437,000. The annual industry costs translates into a total lifetime implementation cost per device of less than $10. For many devices, this is less than 1% of the purchase price. The staff concluded that these costs would be justified because the proposed revisions woulsimprove the general licensees' understanding of the regulations and their awareness of responsibilities attendant to possession of generally licensed devices. The improved understanding and awareness on the part of general licensees will better assure proper handling and disposal of generally licensed devices, and thereby reduce the likelihood of unnecessary exposure of the public to radioactive material from improperly maintained, transferred, or disposed of devices.

This should also result in fewer incidents occurring which means that the societal costs of decontamination and cleanup of such incidents will be reduced. Finally, the adoption of the proposed amendments will provide NRC with the information needed to confirm the assumption that the risk associated with general licensing of these devices is indeed low. Additionally,-it will b

v

f provide NRC with the confidence that generally licensed devices are be'ng regulated in an appropriate manner.

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1 REGULATORY ANALYSIS:

REQUIREMENTS FOR POSSESSION OF DEVICES CONTAINING BYPRODUCT MATERIAL 1 STATEMENT OF THE PROBLEM

1.1 BACKGROUND

On February 12,1959, (24 FR 1089) the U.S. Atomic Energy Comission (AEC) amended its regulations to provide, in 10 CFR 31.5, for general licenses to possess and use byproduct material in certain devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition or for producing light or an ionized atmosphere. (The Comission's regulations apply only in "Non-Agreement States". An " Agreement State is one which has entered into an a

agreement with the NRC under Section 274 of the Atomic Energy Act and thereby has the authority to regulate the manufacture and use of devices containing byproduct material. " Agreement States" are required under the Atomic Energy Act to have similar regulations to those of the Comission.) The devices must be manufactured in accordance with the specification contained in a specific license issued either by the Comission pursuant to 10 CFR Parts 30 or 32, or by an Agreement State.

At present, there are about 150 " specific licensees," i.e., holders of specific licenses from the NRC or from an Agreement State, who manufacture, distribute, service, or repair the generally licensed devices described above.

There are approximately 35,000 " general licensees," i.e., holders of a general 1

1 1

2 license for possession and use of such devices. General licensees possess an estimated 600,000 devices to which Comission regulations apply.

A general licensee, under the' jurisdiction of the Comission or an Agreement State, i: curr:nt-ly required to follow safety instructions on device labels, to test or service a device, or to have such testing or servicing performed by the supplier or other specific licensee authorized to manufacture, install, or service such devices. General licensees are also required not to abandon a device, and to maintain records of testing and servicing of the device. Damage or loss of devices must be reporte[f.

At present, the Comission is notified when possession of devices containing byproduct material is transferred from a Comission licensed specific licensee to any general licensee, through quarterly reports submitted a

pursuant to 10 CFR 32.52(a). These reports identify each general licensee by name and address (including, for an organization, the name or position of a person who may act as a point of contact between the Comission and the general licensee); the type and model number of the device transferred; and the quantity and type of byproduct material contained in the device. Further, the general licensee is required by 10 CFR 31.5(c)(8) to transfer or dispose of such a device only to the holder of a specific license pursuant to Parts 30 and 32 or. to the holder of a specific license issued by an Agreement State. A limited exception to this requirement is provided by 10 CFR 31.5(c)(9),

wherein the-device can be transferred to'another general licensee. A transfer of a device by a general licensee to either a specific licensee or another general licensee must be reported to the Commission within 30 days of the transfer.

__________.____________.-___.___-__._...m___ sm.m __.__.____m

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3 1.2 NRC STUDY OF CONFORMITY WITH GENERAL LICENSE CONDITIONS .

The NRC traditionally has had little contact with general licensees.

However, improperly maintained, transferred, or discarded devices can result in an insicrifAc'nt but unnecessary exposure of the public to radioactive material. In fact the occurrence of.a few such incidents led the Commission to conduct a study from 198? through 1986 (" General License Study") to ascertain the extent of compliance with general license conditions. The results of the study were discussed in SECY 89-289, dated September 14, 1989, and SECY 87-167, dated July 9, 1987. Currently, the regulations do 'not contain any procedure for verifying that a general licensee has knowledge of or is complying with the rules and regulations pertaining to the proper use and disposal of generally licensed devices. Because of the broad range of a

devices covered und1r 10 CFR 31.5, the study was divided into two parts. The first part covered industrial gauging and measuring devices, such as large-scalo level, density, and thickness monitors. There are approximately 16,000 Commission licensed devices in this category containing sources with activities in the 0.5 to 1 curie range. The second part of the study covered devices which greatly varied in design and use, such as self-luminous signs, analytical instruments such as x-ray fluorescence spectrometers or liquid scintillation spectrometers, and smaller-scale thickness, density, and level gauges. The results of the study summarized below were taken from an unpublished NRC report entitled " General; License Study Report."

1.2.1 Part I Results The Part I study included 228 site surveys of general licensees by the study task force and 132 inspections conducted by NRC regional offices. Some e

.. - - - - . . .~. -.- - - - - . . . . . - - -

4 of the Agreement States also contributed data to the " General License Study."

The~ information gathered by the~ study, although from a small sample of general licensees possessing large-scale gauges, clearly established that there is a

.. enmpliance problem. Among the findings of Part I were the following:

• Approximately 15% of the general licensees could not account for all of their gauges.

• A majority of general licensees did not notify the Commission of transfers of their gauges, improperly -

transferred their gauges, or transferred them without properly notifying the Commission.

• At least 25% of the general licensees were not performing required leak tests or maintaining leak-test records; or 4

they were not inspecting a gauge's on/off shielding mechanisms or not inspecting them as required.

• Agreement States reported incidents.of thickness gauges being found in a landfill and in an abandoned paper mill.

1.2.2 Part II Results Although, Part II of the study covered devices that vary. greatly in design and use, the range of problems encountered in Part II is exemplified by ithe problem relating to self-luminous exit signs and beta backscatter gauges.

' Exit signs, which are one of the most common devices, contain tritium' gas that

excites phosphorous-coated glass tubes-to give off-light.

They are used in places.where wiring of-electrical- signs would be difficult.or expensive to do.

4- l Beta backscatter gauges contain a small sealed source and a radiation detector L that measures how much radiation is reflected;back from a material sample.

4 m

5 The concern about these devices is the accountability of the removable source which is about one inch in diameter. Ninety eight interviews were conducted of persons who possess these types of devices. The findings of Part 11 are summarized belows e Nonconformity with the general license conJIttons was very widespread, e Only 16'. of the general licensees for exit signs were aware of the regulatory requirements. ,

• Manufacturers and distributors frequently underreport the number of signs sold to general licensees. General licensees (electrical distributors and contractors) report having about 30% more signs than were listed in quarterly a

reports of the manufacturers.

e Thr:e cases involved missing sources from beta backscatter gauges, e only 45% of those surveyed for backscatter gauges were aware of the genural license conditions, o Vendor reports did not accurately reflect the number of radioactive sources in the possession of general licensees.

As a result when sources were returned to the manufacturer for disposal, NRC was not notified. Hence, NRC records were not accurate. -

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6 2 OBJEC11VES ,

The objectives of the proposad revisions to Parts 31 and 32 of the Commission's regulations are to ensure that general licensees are aware of and understand the requirements attendant to the possession of generally licensed devices containing byproduct material, and to better enable the NRC to verify the location, use, and disposition of such devices.

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3 ALTERNATIVES The following sections describe the alternatives to be considered in this regulatory analysis.

3.1 20 CHANGE This alternative would continue the status quo by making no change in the current regulations governing devices containing byproduct material.

3.2 M00!FY REPORTING REQUIREMENTS This alternative would amend certain regulations contained in 10 CFR Parts 31 and 32 to help ensure that devices containing byproduct material are maintained and trana': vied properly and are not inadvertently discarded. The 4

general mechanism to be used is to require general licensees to verify compliance with the conditions imposed by general licenses.

3.2.1 Knowledge of Conditions in General Licenses The General License Study indicated that many persons with operational responsibilities for generally licensed devices containing byproduct material may not be complying with the general license conditions as they are unaware that NRC regulations impose requirements on persons who possess such devices.

The staff concluded from the study that one reason for this situation is that holders of general licenses are not receiving information on the general license and the conditions of general licenses when they receive a generally licensed device. This is in contrast to holders of NRC specific licenses, who are required by 10 CFR 32.51a to furnish a general license transferee with a

copy of the 10 CFR 31.5-general license or an Agreement State equivalent. The l

.4 8

proposed revisions woul,d add a subsection (d) to 10 CFR 31.6 that requires holders of specific licenses issued by Agreement States to furnish a copy of the general license contained in 10 CFR 31.5 to transferees.

The staff also concluded from the study that a second reason for noncompliance is that the individual within the organization of the general licensee who received the copy of the general license conditions did not inform the individual with operational responsibilities of those conditions.

10 CFR 32.52 requires that the specific licensee report to NRC or the Agreement State agency ths name and/or title of the individual who constitutes the point of contact between the NRC, or the Agreement State r.gency, and the general licensee. The General License Study indicated that this individual, who is frequently in the purchasing department, often did not inform the e

individual who uses the device of the general license conditions. Moreover high personnel turnover frequently destroyed the organization's knowledge of the license conditions. An amendment to 10 CFR 32.52 would require that a specific licensee report to NRC, or an Agreement State agency, information on the devices and the general liceime transferee using the format depicted in the proposed 10 CFR 37. 310. This format calls for identification of the po son responsible for meeting regulatory requirements associated with the device rather than the " point of contact." This change means that the NRC'or the Agreement State would be informed as to the specific individual responsible for ensuring compliance with the general license conditions. If that individual leaves the general licensee,-10 CFR 31.5 would require that another must be appointed in his or her stead and that NRC must be informed of this change.

~ . - . - .

T Proposed subsection (c) of 10 CFR 32.tla would also help ensure that users-of devices are aware of the conditions in the general license. It would ,

provide that the-responsible user be furnished with written instructions and precautions necessary to ensure safe installation, operation, service, and disposal of the device.

3.2.2 Verification of Conformity with General License Conditions Currently, the only communications between a general licensee and NRC is through the requirement that the NRC be notified when a device containing byproduct material is transferred or disposed of. The proposed amendments, in a new item 11 to 10 CFR 31.5(c), would require a general licensee to respond within 30 days to requests from the Commission for verification of information a

relating to the general-license and the general licensee. One new requirement -

would reinforce the importance of accuracy and completeness in responding to the Commission's request - 10 CFR 31.2 would be revised to make a general license subject to 10 CFR 30.9, which requires that information provided the Commission be accurate and complete.

1 It is envisioned that a first request for verification would be made shortly after NRC receives notice from a specific licensee in the quarterly-report that a device containing byproduct material has been transferred to a general licensee.. This first verification request would offer greater assurance that a general ~ licensee is informed of its regulatory responsibilities. The NRC would then make periodic requests for verification to remind general licensee: of their regulatory responsibilities and to reduce the likelihood that devices containing byproduct mater 'I are illegally transferred or inadvertently disposed of.

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. NRC recognizes specific Itcensees of Agreement States as having equivalent regulations and distribution authorizations. However, there is no  !

uniform requirement equivalent to the requirement in 10 CFR 32.52 that

transfers be reported to NRC. The new subsection (a) of 10 CFR 31.6 would - -

require such reporting in a format that transmits information needed by NRC to

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confirm the safe use of the radioactive material. -

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4 CONSEQUENCES The estimates of costs and benefits of the proposed revisions are based on the guidance found in NUREG/8R-0058, " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission" (' Guidelines") and NUREG/CR-3568 *A ._  ;

Handbook for Value-Impact Analysis" (" Handbook"). The convention useu in regulatory analyses is that costs and benefits are measured in terms of changes from the status quo. As for Alternative 1, which is to make no changes in the current regulations, and which represents the status quo, there

• are no costs or benefits associated with it.

4.1 BENEFITS OF ALTERNATIVE 2 As discussed in Sec. 1.2 of this report, general licensees have a lack 4

of awareness of their responsibilities under a general license. The NRC staff believes that this lack of awareness has resulted in incidents of mishandling and improper disposition of generally licensed devices. This, in turn, has resulted in radiation exposure to the public, and entailed expensive investigation, cleanup, and disposal activities. Although the NRC knows of no instance in which exposure limits to the public contained in 10 CFR Part 20 were violated, had the devices been properly handled and disposed of, the exposures would not have otherwise occurred. The proposed revisions are intended to better assure understanding of and compliance with the general license. requirements, and thereby reduce'the likelihood of such incidents, some of which are described below.and summarized in Table 1. Further these revisions would better enable the NRC to verify the location, and disposition of these devices, and thereby confirm both the assessment of low ,

12 risk to the public from generally licensed devices and the efficacy of the general license regulatory program.

In 1985, at the Tamco Steel plant in California, a Cs-137 (1.5 Ci) gauge was mixed in with scrap. The plant and about 51 Mg (tan _ +ons) of flue dust were contaminated. There were no off-site releases or significant doses to workers. The contaminated flue dust was moved off-site for disposal. The decontamination cost was $1.5 million.

Also in 1985, at the US Pipe and Foundry plant in Alabama, one or more Cs-137 (10-50 mci total) gauges were mixed in with scrap. Portions of the steel plant environs, primarily soil, were contaminated. There was no evidence of off-site releases or significant exposure of workers. The contaminated waste (3500 cubic feet) is being stored in an on-site facility, s

The decontamination cost was $600,000.

In 1987, at the Florida Steel plant in Tennessee, one or more Cs-137 (about 20 mci total) gauges were mixed in with scrap. While a truck, that was shipping the flue dust, was on the weight sales, it set off the radiation alarm. The contaminated flue dust, 40K lbs, was moved off-site for disposal.

The cost of the decontamination was $250,000.

In 1989, at the Bayou Steel plant in Louisiana, one or more Cs-137 (0.5 Ci total) gauges were mixed in with scrap. The cesium was melted in a closed system electric air furnace. The contaminated flue dust is still on site sitting in ratiroad cars. Thus far the decontamination has cost Bayou Steel

$50,000, but the disposal cost will be substantially more than $50,000, in 1989, at the Cytemp Specialty Steel plant in Pennsylvania, while making some aerospace grade steel wnich contains some rare elements, the steel

TABLE-1 TYPES OF COSTS LIKELY TO BE AVOIDED BY THE PROPOSED REVISION e

U " ^ F STATE YEAR COMPAN Y METAL ISOTOPE COST $Of TA L ED ST CA 85 Tamco Fe C s-137 1.5 mill gauge in moved of f site Ste et 1.5 Ci scrap for disposal AL 85 US Pipe Fe C s-13 7 600K gauge in on-site

& Foundry 10-50 mci . scrap f acili ty (forever)

Florida Fe C s-13 7 2SOK gauge in moved of f site TN 87 Steel 20 mci scrap for disposal C LA 89 Bayou Fe C s-13 7 SOK - gauge in on site in Steet .5 Ci scrap  : RR cars PA 89 Cytemp Fe Thorium 100K mixed in contaminated Speciality rare steel buried Ste el elements no flue dust UT 90 Nucor Fe C s-13 7 2 mill - gauge in Steel or( site in 200 mci scrap RR cars

• costo of disposal not included and will be subtantial as of 8/1990

i l

14 was found to be contaminated. Some thorium was mixed in with the rare earth elements. The contaminated steel vas sent to brokers for burial, and the l remaining steel was recharged. The decontamination cost Cytemp Specialty ,

Steel $100,000. .

In 1990, at the NUCOR Steel plant in Utah, one or more Cs-137 (200 mci total)gaugesweremixedinwithscrap. The flue dust was made into a fertilizer and loaded into a truck for delivery. This is where the contaminant was detected. Currently, the fertilizer is being stored on site in railroad cars. The cost of decontamination to date has been $2 million which does not include disposal costs.

While it is not certain that the smelted gauges were generally licensed, these cases illustrate the problem potentially presented by a

generally licensed devices which are not properly accounted for.

Based on the known incidents, and the cost of decontamination and cleanup of these incidents, the cleanup costs have been averaging about

$750,000 per year. This cost can be considered as a societal cost which may be averted in the future if the proposed rule is implemented.

4.2 COSTS OF Al.TERNATIVE 2 The proposed revisions of 10 CFR 31.5 and 31.6 would result in costs to three types of entities: (1) specific licensees; (2) general licensees; and (3) the Commission. There would also be' costs to the Commission associated with the rulemaking process.

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15 4.2.1 Costs of Revisions to 10 CFR 31.5 ,

The proposed ievision would require general licensees to respond to <

requests from the Commission for verification of information relating to their general.11*e m t, .This information would help the Comission verify the location of generally licensed devices containing byproduct materials and confirm compliance with the general license conditions imposed by its regulations. The Comission plans to send'a request for verification to each ,

general licensee who receives a generally licensed device soon after the quarterly reports are received from specific licensees indicating th'at a general licensed device had been shipped. This request would cover only those licensees receiving devices shipped during that quarter. The Comission also would periodically sind each general licensee a request for verification 4

covering all devices in the possession of the general licensee.

This planned procedure would require six steps, each step involving a cost to either the general licensee or the Comission.

Step 1. Under the proposed revision, NRC would enter information from the Section 32.310 format into a computerized directory of devices that contains, as a minimum, the information required by the Section 32.310 format.

There would be a Section 32.310 form for each shipment that occurs each quarter. The cost of entering the data on the form into the directory is characterized by the " Handbook" as an NRC operations cost. There are approximately 5,000 shipments per quarter to general licensees under NRC's

- -jurisdiction (i.e., in Non-Agreements States), and it is estimated that it will take a clerk about 2 minutes on the average to enter the information on this form into the directory, from NUREG/CR-4627, " Generic Cost Estimates",

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16 Abstract 5.2 (Revision 1), the composite NRC labor costs in undiscounted 1988 dollars is approximately $41/ hour (hr). The cost per year (yr) of this step would then be: ,

__ Cost (step 1) = 4 quarters /yr x $1.35/ shipment ($41/hr 9 30 shipments /hr) x 5000 shipments / quarter =

$27,000/yr However, this directory is already extant, is being maintained, and data from transfers under current regulations is being entered. Hence the cost of developing the directory and the cost of routine quarterly data entry are sunk costs and therefore outside the scope of this analysis.

Step 2. Under the proposed rules, the Commission would mail a request 6

for verification to each general licensee that received a shipment of devices during a quarter. This step would be characterized by the ' Handbook" as an NRC operations cast, in estimating the cost of this step, it is assumed that the Commission would use the information from the specific licensees stored in the directory and that each request would be computer-generated. it is estimated that the cost of generating and mailing each request is about $1.29 (This includes a $1.00 total cost for preparing the insert and stuffing the envelope which takes about 1 1/2 minutes and $0.29 for minimum postage). The i annual cost of this step would then be:

Cost (ttep 2) = 4 quarters /yr x 5,000 shipments / quarter x

$1.29/ shipment = $25,800/yr.

Step 3. A general Itcensee would have to respond to the Commission's request for verification for those devices transferred to the general licensee h

-.n., n - ,< v -, , , , . , - -n. r.n- .- em w. -.,--,,..w,--- ..wn-. n~.-,- .-..:-, ,

_ . . . ~ . _ . _ _ _ _ . _ _ _ . _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ _

17 during the quarter. The General License Study found that the average time required to locate and verify license conditions for all devices in the possession of a general licensee was approximately 30 min. As the initial  ;

.- verification request pertains only to those devices received during a quarter, -  :

it is estimated that it would take a general Itcensee about-15 minutes of '

staff time to comply. Assuming that the cost to industry of staff time is i

~

also $41/hr, the annual cost of this step, which is characterized by the q

" Handbook" as an Industry operations cost, is estimated as: .

Cost (step 3) - 4 quarters /yr x 5000 shipments / quarter x .

[

$10.25/ shipment = $205,000/yr f l

i When the Commission receives a response from a general Step 4.

licensee.,itwihlogintheresponseonthecomputerizeddirectoryorsomehow record that verification has been received, it is assumed that the staff effortassociatedwiththisstepcostsapproximately$1perresponse(40 '

responses processed per hour 1 1/2 minutes per response). The annual cost of this step, an NRC operations cost, would be estimated.as:

Cost (step 4) 4 quarters /yr x 5,000 shipments / quarter x

$1/ shipment $20,000/yr-  ;

- Step 5. The Comission would mail periodic requests to general  :

!1icensees to verify compliance:with general itcense requirements for all- 4 devices b the possession of the': general licensees.- These periodic -

vertftcation requests would. repeat steps 2 through 4 but would differ from the -

initial verification requests in the number mailed annually. In this

'anklysis,itwillbeassumedthatone-thirdoftheapproximately28,500 -

M ^ h

<-rc-- w w--- n- e r e e,ne we ,-~~,w--e r=-rwr---nnr,-*~ n- <-w<- -w--m v n,w res-w~-s--~-+ w-v- r , e ,w m w sees ,-v e w n- w x m we,N

i 18 general licensees (9,500) under NRC's jurisdi,ction would receive a verification request annually. Although there are approximately 35,000 l general licensees, about 6,500 of these licensees possess material that will be excluded from the survey because of the nature and quantity of the material (i.e. calibration /refarence sources in microcurie quantities, peta backscatter gaugesinmicrocuriequantities,andstaticeliminatorscontainingPo-210).

The cost to the Commission of sending a single verification request and

-processing the response has been estimated above to be $2.25. Therefore, the ,

annual cost to the Commission of the periodic verification requests is estimated as:

Cost (step 5) = 9,500 requests /yr x $2.25/ request = $21,375 If the information provided by the general licensee should change at a ,

s later date, the general licensee is required to inform the NRC. It is estimated that about 100 such notices might occur annually. The time to enter the data from a licensee into the computer system is estimated to be about 3 minutes per entry. A total of about 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> would be required to enter all of the data into the database. The estimated cost of this activity is $205.

Step 6. The cost to a general licensee of responding to a periodic verification request is greater than the cost of responding to the initial <

request'because the former covers all devices in the possession of the general licensee. As discussed earlier, it is estimated that one-half hour of staff time is required for verification for all devices. The annual costs to ger,eral licensees of responding to periodic verification requests is then:

4 Cost (step 6) = 9,500 requests /yr-x $41/hr x- -

0.5 hr/ request = $194,750/yr

, . , - , , m. ,r--*c,---- -v-- w -s

19 I 1

If the information provided by the general licensee to the NRC should change, the general licensee is required to inform the NRC. It is estimated that about 100 such notices might occur annually. The time needed by a licensee to prepare each request is estimated to be 15 riinutes, giving a total of about 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> for all the requests. The total cost for all licensees is estimated to be $1,025.

To sumarize, it is estimated that the annual operations costs of the proposed revision of 10 CFR 31.5 are $400,775 for general licensees and

$67,380 for the Comission in undiscounted 1988 dollars. These costs do not include costs to the Comission of creating and maintaining a computerized directory of devices, which are considered sunk costs.

4 4.2.2 Costs of Revisions to 10 CFR 31.6 The proposed revisions add subsections (a) and (d) to 10 CFR 31.6, which may entail some costs to holders of specific 1_icenrees issued by Agreement States. There are i.pproximately 150 specific licensees in the United States, of which approximately 90 hold licenses issued by Agreement j

States and approximately 60 hold liconses issued by the Comission. Only the l former are affected by the proposed revisions.

1 Subsection (a). This new subsection would require holders of specific i

licenses from Agreement States to file with the Comission the Section 32.310 f form for each shipment to a general licensee under NRC's jurisdiction.

Currently, some Agreement State specific licensees send reports to the l

l Comission voluntarily.- There would be only negligible ccst for these

-specific licensees to substitute the Comission's format. For the other i: --

_ . . _ . _.. ._ _. __ ._.___.-m...._._. . _ . _ _ _ _ _ . _ _ _ _

. . . I 20 o

D l specific licenstes from Agreement States, this subsection would impose a new l cost. It is estimated on the basis of the NRC staff's understanding of the-  ;

industry, that for each quarterly report there is an average of two staff f hours (582) spent and postage of $4. It is assumed that this cost would apply for one-third g30) of the specific licensees-in Agreement States. The annual e l cost of the new subsection would then be-estimated at

- Cost (subsectiona)=30 reports /quarterx$86/reportx 4 quarters /yr = $10,320. - L Based on quarterly transfer reports received by the Commission, approximately 25% of- the specific licensees generate these transfer reports by computer. The proposed revisions would require some format revisions to the computer programs. It is estimated that it would require no more than two 4

days (16' hours) of staff effort per specific licensee to complete the  ;

revisions. This is a one-time cost that would be characterized as an industry ,

implementation cost. Approximately 38 vendors would expend about 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> each, or 608 hours0.00704 days <br />0.169 hours <br />0.00101 weeks <br />2.31344e-4 months <br /> at $41/hr for a total cost of $24,928.

Subsection (d). This new subsection would require holders of specific licenses from Agreement States to provide genera 111censee transferees with copies of the general license contained in 10 CFR 31.5, instead of the i Agreement State license. The associated cost is small and is estimated to be about $1.30 per shipment for preparing the insert, stuffing the envelope, and postage.- The annual cost of this new subsection is then estimated to be: ,

I 9

.a,_,, e. m., . , -,', . , , , , , me. . . .. , . . . -

m , m..- ,,.~y - - , . ,. . m- 5 .c..- , n .m. v. ,-

l 21 l

, Cost (subsection d) = 20,000 shipments /yr x $1.30/ shipment = $26,000/yr Thus the total cost to holders of specific licenses from Agreement States is estimated to be $36,320/yr. There is also an industry implementation cost estimated to be $24,928.

4.2.3 NRC Development and Implementation Costs NRC development costs are the costs of preparation of a regulation prior to its promulgation and implementation. Such costs may include expenditures for research in support of the proposed regulatory action, publishing notices of rulemaking, holding public meetings, responding to public comments, and issuing a final rule. The General License Survey, which e

is the research in support of the proposed regulatory action, has already been performed and is therefore a sunk cost outside the scope of this analysis.

Development costs within the scope of this analysis are the costs of proceeding with a rulemaking. These are mainly the costs of the effort of NRC professional staff members in the Office of Nuclear Materials Safety and Safeguards (NMSS) and in the Office of Nuclear Regulatory Research (RES) expended in developing the rule, and the cost of publishing a notice of proposed rulemaking (NPRM) and the final rule in the federal Register.

The proposed regulatory action is an amendment to existing regulations with annual costs to industry of less than $1 million spread over thousands of specific and general licensees. The action's preparation cost to NRC is estimated to require a total of two-thirds of a professional staff-year.

Based on Abstract 5.2 (revision 1) from Generic Cost Estimates, the estimated

- . . . ~ . . - _ - . - - . ._- - - - - - -.

22 ,

t cost of one NRC professional staff is $74,000/ staff-yr. The component of NRC'S develo pent costs due to staff effort, then, would be $49,600.

The proposed rule changes are relatively short and can be printed in two pages in the federal Register. The preamble is also relatively short ud .. .

would not require more than six pages. It is estimated that publication of the NPRM and the final rule would require a total of 16 pages. From Abstract 5.1, the cost of a page in the Federal Register is $600. Thus, the cost of publishing the NPRM and the final rule is estimated to be $9,600. The total NRC development costs, which would occur in a sigle year, are estimated to be

$59,200.

NRC implementation costs are those ' front-end" costs necessary to effectuate the proposed action; they may arise from the necessity of a

developing procedures and aids, e.g., regulatory guides, to assist licensees in complying with the final action. The proposed revisions would affect specific licensees and general licensees for devices containing byproduct material . There are no implementation costs for NRC regarding general licensees. However, specific licensees would have to be informed of the regulatory changes. This would require the composition of a short regulatory aid known as an "information notice" and mailing the notice to the

- approximately 150 specific licensees, it is estimated that this cost would not exceed $4,000. The total one-time NRC development and implementation costs are then estimated to be $63,200. '

4.2.4 NRC Enfercement Costs -

Enforcement costs a.e those costs incurred by NRC after it determines that a licensee is not in compliance with the agency's regulations. The

1. % y ye-- ---e V y-w-r + e m r +,- -ww,--g + --

23 Office of Nuclear Material Safety and Safeguards has indicated that the proposed regulatory action may result in an increase in enforcement activities l on the part of the NRC. Costs per enforcement action would likely remain  !

unchanged, but the number of enforcement actions might increasa if the additional information available to the NRC indicates that general licensees have lost or abandoned devices or are handling the devices in an unsafe manner more frequently than currently estimated.

NHSS estimates that on-going program office costs of 0.5 to.l.0 FTEs will be required to provide additional regulatory oversight in the form of providing copies of regulations and directions on the disposal of devices to general licensees. ,

Data obtained from the Inspection 766 computer system indicate that, e

during a five year period of time, NRC conducted 2016 inspections of specific

-licensees with gauges. About 48% (964) of the reports showed no violation.

The other 52% (1052) of the reports show I or more violations of regulatory requirements. A total of 2105 violations were recorded in the 1052 inspection reports that contained violations. Thus past records indicate that if NRC -

specific psuge users are inspected, in about half cf the inspections the licensee would fail to comply with an average of 2 regulatory requirements..

If general licensees' performance-is similar to specific licensees, one could expect an additional 4,940 (9,500 X ..:.) survey submittals with violations per year. This number is believed to be on the high side because specific licensees tend to have more regulatory requirements to comply with than do ,

general licensees. -

r , - y m..--- -5,---psvye-.c. . ,., g. --. ..p--

24 I

Based on an annual escalated enforcement rate for lost devices of 1.5% for specific licensees, it is estimated that about 75 general licensees might require escalated enforcement actions per year. Current practice of the  ;

Offict of Enforcement (OE) requires about 2 FTEs to p*ecer*.approximately 100 actions per year, Thus, the proposed rule would require an additional 1.5 FTE2 for OE to process the additional enforcement actions under the current practices. However, if this rule is adopted, the existing inspection and enforcement system will be streamlined to provide for a better use of OE resources. Additional resources, estimated to be 4.5 FTEs, will be needed by i

the NRC regional offices for followup inspections and required enforcement activities for non-escalated actions. These resources, however are included in the NRC's FY 1992 budget. There are also costs incurred by other offices, e

such as Public Affairs and Congressional Affairs, that are involved in the enforcemant action process. However, the total combined resource needs hr these offices is estimated to be less than 0.2 FTEs. This workinad can be absorbed by the current staff.

Using the estimates provided in ' Generic Cost Estimates,"

NUREG/CR-4627 Rev. 1, for NRC labor rates, the techniques contained in the standard NRC regulatory analysis references, and assuming a 30 year time horizon, total estimates for NRC enforcement range from $2.4 million to $3.6 million, if one uses a 5 per:ent discour.t rate, if one uses the 10 percent discount rate, the costs could range from $1.5 million to $2.3 million.

lAn escalated enforcement action is: a Notice of Violation for any Severity i Level 1, II, or til violation; a civil penalty for a violation at any severity level; and any order based upon violations.

I l

25 P

4.2.5 Summary of Costs The costs of the proposed action will now be summarized in terms of the attributes defined in the ' Handbook *. In accordance with the ' Guidelines",

the present value of annual costs will k cstimated using a 10% real annual discount rate. To obtain a present value, the number of years over which the costs are incurred must be estimated. These annual costs wi'11 continue to be incurred as long as there is commerce in the subject devices, at current levels, with the prooosed revisions in effect. This period will be, assumed, somewhat arbitrarily, to be 20 years. Then, with use of Table C.2 of the Handbook, the present valise of a cost is its annual cost multiplied by 8.51.

Table 2 summarizes these costs. It should be noted that the enforcement costs identified in paragraph 4.2.4 above are not included in the summary since they 6

are not a direct cost of this rulemaking.

TABLE 2 Summary of Costs to NRC and Industry of Proposed Changes 4 Cost ($1000)

Item Upfront Annual Present Value NRC development 59 NRC implementation 4 NRC operation 67 570 Industry operations-General licensee 401 3413 Spectfic licensee 36 306 Industry implementation 25

26 5 DECISION RATIONALE lt is recommended that the proposed action be adopted because it represents a reasonable means for the Commission to fulfill its obligation to protect the public halui .dafety. It will better ensure that general licensees are aware of those requirements with which they must comply, as well as provide the information on the location, use, and disposition of generally licensed devices needed to confirm the efficacy of the general license regulatory program and the estimates of low risk from these devices. The rationale for this recommendation follows.

I The results of a survey conducted by the Commission indicated that there is noncompliance with the general license requirements contained in 10 CFR 31.5(c). Such noncompliance presents a risk of insignificant but i a

! avoidable exposure of the public to radiation as a consequence of improper handling or disposal of the devices generally licensed. The General License Study revealed that a major reason for noncompliance is that users of the generally Itcensed devices are unaware that there are regulatory requirements associated with the possession and use of these devices that must be met.

The proposed regulatory action would establish a reasonable procedure l

to ensure that general licensees are aware of the provisions associated with the general license and comply with the applicable regulatory requirements.

It is believed that increased awareness and understanding of the Commission l requirements on the part of the general licensees will increase the likelihood i that general licensees will comply with those requirements and thereby reduce the potential for unnecessary radiation exposure of the public from improper handling or disposal of generally licensed devices. Promulgation of this proposed rule should also result in supplying the NRC with the information

1 l

27 that would confirm the assessment that the risk associated with these devices ,

is indeed low, and provide confidence that the use of generally licensed devices is being regulated in an appropriate manner.

It it 9ttietted that adoption of the proposed regulatory action would result in upfront development and implementation costs to the Commission of

$63,000, annual costs to industry and the Commission of $437,000 and $67,000, respectively, and an industry implementation cost of $25,000. These costs translate into a very nominal maximum cost of about 1% of the cost oof a device over the lifetime of the majority of devices (see Section 7).' Although the NRC estimates that the risk associated with these devices is small and therefore any risk reduction realized through improved compliance with the Commission's regulations by general licensees will also be small, the staff a

has concluded that the benefit of the increased confidence, in both the assessment of low risk and the efficacy of the general license regulatory program, outweighs the nominal cost per device. The benefit to be realized even further overshadows the nominal costs when considered in light of the possible avoidance of the substantial cicanup costs which have occurred because of past improper disposition of generally licene.ed devices.

28 6 IMPLEMENTATION ,

The proposed regulatory action is not expected to present any significant implementation problems. The computerized directory that w6uld be m)" ired has already been implemented by the Connission. The only action needed for implementation is that the Commission develop and mail an information notice to specific licensees to inform them of their new responsibilities under the amended 10 CFR 31.6.

O I

e l

l I

i l ._ _ _ _ _ _ _

l 29 7 EffECT ON SMALL ENTITIES ,

As was discussed in Sec. 4.2.1 and 4.2.2 of this analysis, the proposed action would have some economic impact on specific licensees and on general licensees of devices containing byproduct material. There are approximately 35,000 general licensees of which 28,500 are affected and approximately 150 specific licensees, many of whom may be "small edities" within the meaning of the Regulatory Flexibility Act (P.L.96-534). However, as will now be demonstrated, the economic impact on these entities would not be significant.

In Sec. 4.2.1 of this analysis, it was estimated that the cost of responding to the Commission's initial verification request to general licensees would bei $205,000/yr. It is estimated that there are approximately 80,000 devices transferred from specific licensees to general licensees under theCommission'Ijurisdictionperyear. In Sec. 4.2.2, it was estimated that the cost to specific licensees of complying with the requirements of new subsections (a) and (d) of 10 CFR 31.6 would be $36,320/yr. It is very likely that the specific licensees would pass on this cost to the Commission's general licensees.

The periodic verification requests impose an additional cost on general licensees. In Sec. 4.2.1, it was estimated that the annual cost of cesponding the periodic verification requests is $194,750. It is estimated that there are approximately 600,000 devices in the possession of the Commission's general licensees. -

The total cost to the general licensees as a result of this rulemaking, for both the initial verification and the periodic followup, would be

$399,750. Costs expected to be passed on to the general licensees from the specific licensees are an additional $25,000. The total sost to the general O

l 30 licensees is $424,750. Since there are approximately 400,000 devices in the hands of general licensees, the average cost per device is about $1.06.

The price of the generally licensed devices ranges from $185 to

$250,000, llowever, many devices in commerce are density or thickness gauges containing byproduct materials such as americium that cost from $1,000 to

$10,000. The useful lifetime of such devices is limited to 3 to 10 yr by the durability of their electronic components. For devices with a 10-yr lifetime, the cost of the proposed action is estimated to be about $10 which is less than one percent of the initial cost of most devices. Therefore, the proposed action would not have a significant economic impact on small entities.

4

' '_ft. .- . mm-,

Federal Regleter / Vol. 56..No.' 349 / Friday. December 27.51991/ Proposed R:les 87011 lr licensed devices and presumably reduce the potential for incidents that could result an unneossaary radiation exposure to the public.

DAfts:The comment period expires

, htarch 12.1992. Commenta received .

after this date will be cm.dered if it is practicable to do so, but the NRC is able '

to ensure consideration only for comments received on or before this

' date.

Appnastas: Mall written comments to the Secretary U.S. Nucleat Regulatory Commission. Washington DC 20555.

Attentioru Docketing and Servia Branch. Deliver comments to One White Filnt North 11555 Rockville Pike.

Rockville. MD. between 7%D are and 4:15 pm on weekdays. Copies of the draft regulatory analysie, as well as copies of the commente received on the proposed

' rule, may be examined at the NRC Public Document Room.2130 L Street NW (Lower LAVeI). Washington. DC.

• P0st PUsrTHEst IsePCstesATsO88 COsrfACTI Joseph I. Mate. Offloe of Nuclear Regulatory Research U.S. Nuclear Regulatnry Commission. Washington.

' --. DC 20555, telephone (301) 492-3795.

NUCt. EAR RE00L.ATORY COMMISSION . Badsmund l'

On February 12,1959 (24 FR 1000), the 10 CFM Parts 31 and 33 Atomic Energy Commission amended its MIN St50-ADM regulations to provide a generallicense f

NM""'* U " E'""'I'" d conta in I ou m suring.

I C gauging, and controlling devices. Under the current requirements for possession Acesscy: Nuclear Regulatory of a generallicense,certain persons may Commission. receive and use a device containing ACTION: Proposed rule, byproduct materialif the device has been manufactured and distributed in summany:We Nuclear Regulatory accordance with the specifications a i Commission [NRC)le proposing to contained in a specific license issued by amend its regulations goveming the safe the NRC or by an Agreement State. A i use of byproduct materialin certain specific license is issued based upon a measuring, gauging. or controlling determination by g regulatory authority devices.The proposed changes, among that the safety features of the devloe other things would require general and the instructions for safe operation licensees who posses these devices to are adequate and meet regulatory

( provide the NRC information about the requirements.The generallicensee is I identification of devices and the people required to comply with the safety responsible for the devices. Further, instructions contained in or referenced specific licensees who are distributors on the label of the device and to have of generally licensed devices under 10 the testing or servicing of the device CFR 31.5 would be required to use a performed by an individual authorized uniform format when submitting the to manufacture, install. or service these quarterly transfer reports to NRC.The devices. A gereers'.:, licensed device is a proposed rule is intended to ensure that " black box." that is, the radioactive generallicensees are aware of and materialis c'ontained in a sealed source understand the requltements for the ' usustly within e shielded device.The possession of devices containing device is designed with inherent tiyproduct material.%1s awareness will radiation safety features so that it can better assure that generallicensees will be used by persons with no radiation comply with the requirements for proper training or experience.Thus, the general i handling and disposal of generally license policy is a mechanism to

_ _ _ )

4 r

37012 Federal Register / V 1. So, N . 249 / Friday. December 27, 1991 / Proposed Rules Jimphly the license process so that a have been avoided. In addition. the compatibility.%e Commission would tse.by-case determination of the cleanup costs were in excess of four appreciate comments on this suggestion.

sdequ:cy of the radiation training or million dollars with additional costs An estimated 35.000 persons use

xperience of each user is not incurred for the staff efforts of certain measuring, gauging or .

necessary. regulatory agencies, controlling devices under the NRC's in consideration of both the risk generallicense. NRC regulations that 4 Discussion affect these generaillcensees' assessment and incidents like those

%:re tre about 600.000 devices that noted above the NRC conducted a responsibilities end that are presently cintaln byproduct materialis use by three year sampling (1984 thru 1966) of being amended are 10 CFR 31.2. 31.4.

about 35.000, licensees under the generallicensees (taken from the 31.5, and 31.0. Under 10 CFR 31.2.

Commisel n s generallicense regulatory vendor's quarterly reports) to determine ' Terms and Conditions." all general whether there was an accounting licensees are subject to certain

{rogram.

een contacted Generallicensees have not by NRC on a regular provisions of part 30 and also parts 19, roblem with b: sis because of the relatively small [icenses, and if auge so,what users remedia under20, action feneraland 21.ne proposed revision to r:dlation risk posed by generally was i 31.2 would also subject all general licensed devices.Hese devices have might conducted be necessary. The samplinfs both by telephone cal and licensees to the requirements of 10 CFR

,urvived fires and explosions on many site visits.He sampling revealed 30.9. " Completeness and Accuracy of '

occasions without a totalloss of several areas of concern regarding the Information." which imposes certain shielding. %ey have been damaged by use of radioactive material under the requirements regarding the m:lten steel, and hit by construction generallicense provisions. On the bests completeness and accurac of the -

vehici;s with only rninor losses in information submitted to t e NRC by "8 h alnta ng of the samptlnf.

is:(1) Alack o awareness of the NRC concluded that not now imposed upon general licensees f es P, appropriate regulations on the part of licensees.

tfeinteht y:ne ess, gere have been a the user (generallicensee) and(2) Section 31.4 of to CFR part 31. .

t inadequate handling and accounting for "Information Collection Requirements:

Eont ni d osc ive mate a h ve not these generally licensed devices.ne OMB approval, lists the vartous i rl handled or die ed of NRC further concluded that these two sections of part 31 that contain ]

been andr sNed n radiation expo e of the pr blems could be remedled by more approved information collection ublic. Although no significant public trequent and timely contact between the requirements. paragraph (b) of I 31.4 is eilth cnd safety hasards resulted from generallicensee and the NRC.his being amended to add i 31.6 to the and c nclusi n by the NRC provides the approved listing.

these incidents,if proper dispos:1 procedures had been folhandlinfowed, .

basis for the regulatory changes Section 31.5. "Certain measuring.  %

these av:idable exposures would not ,

gauging or controlling devices, provides proposed in this action.

h:ve occurred. For example, one or An estimated 70.000 Agreement State for a generallicensee to acquire, more cesium type gauges were mixed in receive, possess, use. or transfer licensees use the types of sources and with s:me scrap metal that was melted byproduct materials. It also specifies the devices covered by the amendments down ta form steel and the entire batch responsibilities of generallicensees being proposed today for the NRC's cf ste:1 was contaminated. In another regarding the use of byproduct inst:nc2, a static eliminator bar with general licensees. Consequently, the States will play an important role in materials. Under the proposed revisions j 215 millicuries of americium 241 was a new paragraph (c)(11) would be added eent ta a sanitary landfill over which the achieving improved regulatory oversight I on a national basis, hiany of the States to require the generallicensee to NRC h:s no lurisdiction.There have already have accountability programs in provide specific information to the NRC been oth:r types of incidents involving upon request. This information would .

NRC g:nirally licensed devices place no Agreement States participated in the development of this include the complete name and address; Including damaged devices. leaking or rule and indicated agreement with the specific information about the desice, y contaminated sources. and equipment such as manuf acturer, model number, m:lfunctions. !!owever, lose of concept of the proposed rule. Specific comments from the Agreement States and number of devices; name, titic und accountability, as occurred above, were adopted except for suggestions telephone number of the person rem: ins the most frequent incident and the predominant concern, that the NRC charge genet allicensees responsible for controlling the use of the j llec:use of these occurrences, the fees and that there is no need for a device the address where the device is j standard format for submitting located or used; and whether the NRC's Office of Nuclear hinterial Safety end Saf: guards (NhtSS) conducted a information.The lee issue will be specific requirements of paragraph (c) of ediological risk assessmerit addressing addressed separately.The proposed rule i 31.5 have been met. in addition a storage of devices in warehouses, provides flexibility in the use of the proposed revision to paragraph (b) of disposil in scrap yards, incineration of standard format. I 3t.5 would delete all references to waste. melting in a smelter, and disposal he Commission is considering specific licenses issued by Agreement in a 1:ndfill. NhtSS included in the risk making the amendments a matter of States that authorize distribution of compatibility for the States. The NRC deviess to persons generally licensed by essessment an incident at a steel comp:ny in 1903 (discussed in NUREG- staff has suggested that the amendments Agreement States.

1108. *The Auburn Steel Company be categorized as Division 21evel of The registration an.1 verification Ridicactive Contamination incident") compatibility.This level of compatibility system contained in the proposed th:1 probably represents a worst case requires that States address provisions amendments to to CFR parts 31 and 3:

stentrio for generally licensed gauging in NRC regulations relating to basic willinclude all generallicensees, devtces. Although individual dotes were principles of radiation safety and including those who previously acquired 1:w and within prescribed limits for regulatory functions without necessarily radioactive sources. lf older sources are aposure of members of the public, they using identicallanguage. States may transferred they would be subject to the nev:rtheless represent unnecessary also adopt requirements more restrictive same requirements as newer sovrees cdditional public exposure that could than NRC rules under this level of and the registration system in intended

e

' Tcd:ral R:Rist:r / Vol. 56, No. :49 / Friday, December 27, 1991 / Proposed Rules 67013 to capture them. Generallicensee would be amended to read "Cencral from t to 3 years. Any failure to respond trcnsfers of sources are limited to either ti,:ense to distribute, install, and service or any reparts ofInst devices would transfer to specibe licensees or other devices generally licensed in i 31.5." initiate NRC follow.up action. This generallicensees by 'he existing to CFR 32.51a,"Same: Conditions of contact between the NRC and the provisions of 10 CFR 315(c) (8) and (9). licenses," presently imposes conditions general licensee would allow the NRC to g

in both cases, licensees must notify the on applicants for a specific license to validate and update the information NRC of the transfers. lf the specific manufacture or initially transfer currently contained in the data base that lictnsee is a 10 CFR pe't 32 or generally licensed devices to general the NRC maintains for its general Nreement State equivalent distributor, licensws.The addition of proposed licensees.

H reporting requirements ci the paragraph (c) to i 32.51a would requite Although these proposed proposed rule would app!) to any such specific licensees to provide requirements would impose additional subsegoent tr6nsfee The current NRC recipient users of generally licensed costs on licensees, the Commission has b( data bast ?lthough limited, b.e devices with written instructions and estimated these to be nominal (on the h_ idcatub . ' of . genatallicensees do precautions to ensure that the devices order of $10 per device). Accordingly, 2; au!res. ges as early us 1954. The are used safely, in additle 1, these the Commission believes that the 2 NM uf 91ans to contact these specific licensees would be required to increased compliance by general 1%aca and any new generallicenree provide those users with information licensees and confidence in the cs p:rt of the enhanced oversight effort. regardlag testing requirements, transfer

] At present, to CFR 3: a4 " General and reporting requirements, and appropriateness of the generallicense 7 program poter ' ally afforded by these

'c license to install devices generally d.sposal optio.y for the devices being new requirer snts outweigh this cost.

lic:nsco m i 31.6 " provides a generel transferred. Nonetheless, the Commission lic:nse to certain specific licentees Nan 10 CFR 32.52," Material transfer h"

reports and records, currently requires particularly requests comments on this ccee.nent States to insta!! or service matter

• dIvices used under i 31.E.The current specific licensees authorized to rryulation, to CFR 31.6. is not clear with distribute devices to generallicensees to At the time of the final rulemaking on this matter, the Commission intends to rsvct to time restrictions. tc CFR file transfer reports with the NRC on a 150.20(b)(3), imposes a 180-day.ptr. quarterly basis. The revised regulation provide for an interim enforcement calendar. year limitation on the activities would prescribe the format to be used policy to supplement tne current of Agreement State 1.icensees in non, when submitting transfer reports to the Enforcement Policy in 10 CFR part 2.

Agreement States. The proposed NRC.The proposed format would appendix C, to address violations cmendments to i 31.9 would remove this provi.le more detailed and complete arising from the proposed regulations.

restricNn for i 31.5 licensees. This information about the general licensee The interim poh,ey wo Id remain in r-ch nge will be convenient to the NRC, to whom the device is trar.sferred.The effect for one cycle of the notice as.1 Agreement States, and manufacturere format is presented in proposed tubpart response program, approximately three b c:use it will reduce and almpliff E. I U.310. Licensees who do not use the years. Under the existing NRC pap;r work without increasing the risk prescribed format would be permitted to Enforcement Policy, significant to public health and safety. The provide all of the information requ"ed violations such as those involving lost proposed i 31.6(a) would require the by the format on a clear and legible sources may result in escalated action generallicensee holding a specific record. In addition, specific licensees including civil penalties. The interim licznse from an Agreement State to would be required to identify a person policy would provide that in the initial report to the NRC all persons receiving a responsible for meeting the phase of the implementation of a notice device from the liunsee, as specified in requirements associated with the and response program, enforcement the accompanying proposed revision to possession of the generdy licensed action would not normally be taken for i 32 52. Proposed 131.0(d) would require device rather than simply identifying a violations identified by a licensee in the licensee to supply each of the paint cf contact at the generallicensee's submitting itformath.n pursuant to t5c recipients of a generally licensed device location. Proposed regulation provided e copy of the generallicense contained After receipt of the quarterly transfer appropriate corrective action is in 13t.5, Proposed i 31.6(e) would reports from the specific !!censee under irti tiated.This change from the require that written instructions and i 32.52, the NRC would send letters to Commission's normal enforcement precautions be provided to persons the generallicensees who received the . policy in to CFR part 2, appendix C,is to servic;ng a generally licensed device. devices during the preceding reporting remove any disincentive to identify Proposed 5 31.6(f) would hiso require a period requesting them to verify in deficiencies caused by a concern of

=

. person performing romine installation / writing that they had purchared the potential enforcement action.This strsicing/ relocation of these devices to devices containing byproduct material action would be taken to encourage notify the appropriate NRC regional and that they understand the general licensees to search their office at least 3 working days prior to requirements of the generallicense.The facilities to assure sources are located, the start of the activities.Th!a ger.erallicer.see under proposed to determine if applicable requirements notification would allow for a level of 6 31.5(c)(11)(ii) would be required to have been met, and to develop periodic inspection of those activities respond to the NRC by letter and to appropriate corre* e action when that intentionally place a worker ir venty safety-related information about deficiencies are fotnd. However, direct contact witi the device or an the device and its location. Thereafter, enforcement action will be considered unshielded radMtion source. It is not notices wou d be sent periodically to the for violations involving the failure to intended that the prior notification generallicensees requesting that they provide the information requested or requirement apply in cases where a verify that they still have the devic 3, take appropriate correct *ve actions or

= rediological hazard due to an accident verify the safety.related information, willful violations including the submittal or a malfunction of the device exists. D and remind them of their regulatory of false information. S nctions in those l be consistent with the proposed respcnsibilities in using the device.The situations may include ciM penalties an  !

modifications, the sution heading frequency of these letters may range well as orders to limit or svoke the

l lt Federal Redster / Vcl. So, N2. 249 / F.iday, Decc.nber 27, 1991 / Proposed Rules 67014 Cathority to posseas radioactive sourcea entitles.The NRC has adopted size toto. ea Stat. 950 es amended (42 U S C und:t a general hoense. standards that classify a small entity as 2:01(on ne whose gross annual receipta do not 2. Section 31.2 is tevised to trad as EnvironmentalImpact Categorical exceed $3.5 million over a 3 year period. gogow,.

' Endusion The proposed rule affects about 35.000 The NRC has determined that the persons using products under this i 31.2 Terms and Conditions.

propos:d regulations are the type of generallicense, many of whom would be The generallicenses provided in this cction d: scribed in the categorical clasbtfied as a small entity. Ilowever, part are subject to the provision of cxclusion to Cf'R 51.22(c)(3)(lii). the NRC believes that the econot@ ll 30.9,30.14(d),3034(a) to (e),30.41 Th:refore, neither an environmental impact of the proposed requirements on 30.51 to 30.03. and parth 19,20, and 21 of impact statement not an environmental any generallicensee would be this chapter 8 unless Indicated otherwise assessment has been prepared for this negligible.The proposed rule is being in the language of the generallicense, propos d regulation. Issued to better ensure that the general 3. In i 31.4 paragraph (b) is revised to P perwork Raductico Act Statement licensees understand and comply with read as follows:

regulatory responsibihtles regarding the The proposed rule amends the generally licensed radioactive devices in 5 31.4 Information coI6ection inform: tion collection requirements that their possession. requirementa: OMB approvat.

cre subbet to the Paperwork Reduction . . . . .

Act d 1960 (44 U.S C. 3501 et seq.). This Backfit Analysis (b)The npproved information propose 4 mle has been submitted to the The NRC has determined that the collection requirements contained in this Office of Wnagement and Budget for backfit rule.10 CFR 50.109, does not part appear in il 31.5,31.B. 31.8, and revisw cnd approval of the paperwork apply to these proposed rules and 31.11.

therefore a backfit analysis is not . . . . .

.rting burden for this required because these propoaed 4. In n 31.5, paragraph (b)is revised reaution 's estimated to amendments do not involve any and paragraph (c)(11)is added to read

' u -

] minutes per response, provisions that would impose backfits ,, goginw,:

lor reviewing as defined in 10 CFR 50.109(a)(1).

as, searching existing data $ 3t.5 Certain measuring, gouging. or

.rcis, gathering and mkintaining the List of Subjects in: contromng devlees.'

dzte nnded, and completing and 70 CFR Part 37 reviewing the collection of information. (b)The generallicense in aragraph Send comments regarding this burden - Byproduct material. Criminal (a) of th,is secuon applies o y to cettmate or any other aspect of this penalties, Labeling, Nuclear materials, byproduct material contained in devices collection of information, including Packaging and containers, Radiation n a ta en sugg:stions for reducing thi.e burden, to protection, Reporting and recordkeeping d o c the information and Records requirements, and Scientific equipment. Ad 6 a Msn:gement Branch (MNBB-7714) U.S. 20 CFR Part 32 specific license issued pursuant to l 32.51 of this chapter or in accordaxe a go , t t e Dea By roduct material. Criminal with the specifications contained in the ,

Officer. Office of Information and penafties, Labeling. Nuclear materials, Regulatory Affairs NEOB-3019,(3150- Radiation prctection. Reporting and 8'"'fallleense of I 31.6.

recordkeeping requirement 3, and (c) , . f 0013 end 3150-0001). Office of (11) ShAll respond within 30 calendar Manag ment and Budget, Washington. Scientific equipment. {

days of receipt of a request from the p DC 20503. For the reasons set out in the Nuclear Regulatory Commisslon to ReEul ^"'1 I ';' preamble and under the authority of the Atomic Energy Act of 1954, as amended, verify the following information and any j

The NRC has prepar?d a draft other such infor: nation as may be >

the Energy Reorganization Act of1974.

reFulatory analysis of tnis proposed as amended, and 5 U.S.C. 553, the NRC requested by the Commission as it regulation. %e analysis examines the relates to the general license. Further, is proposing to adopt the following cost end benefits of the alternatives amendments to 10 CFR parts 31 and 32.

the generallicenne shall notify the considered by the NRC.Tne draft Director of Nuclear Matertal Safety and anatysis is available for inspection in PART 31-GENERAL DOMESTIC Safeguards, U.S. Nuclear Regulatory the NRC Public Document Room,2120 L LICENSES FOR BYPRODUCT Commission. Washington DC 20555 Street NW, (Lower Level). Washington, MATERIAL within 30 calendar days if any of the DC. Single copics of the draft analysis requested i ~ irmation should change.

may be obtained from Joseph J. Mate, 1.ne authority citation for part 311s (i) Name had complete address of the -

Officer of Nuclear Regulatory Research, revised to read as follows: generallicensee.

U.S. Nuclear Regulatory Commiss.u 1. Authority: Secs. 81.166.133. 68 Stat. SJ5, (ii)Identificatian of specific Washington. DC 20555, telephone: 301- 948,954, as amended (42 U.S C. 2111. 22o1. Information cbout the device, such as:

492-3?95. 2233h sees. 2o1, as amended. 202. 68 Stat. the manufacturer, model number, the 1242, as amended. 1244 (42 U.S.C. 5841. 5842).

R:gul: tory Flexibility Cc-tification Section 3te also issued .mder sec. 274. 73

' Auen*n i' d'"c*d Par'icularir '* 'h* j Bas d on informatica available at this stat. esa (42 US.C. 2021). .

steg1 of the rulemakmg proceeding and .

For the purposes of sec. 223,68 Stat. 958. as P ns g tj in trcordance with the Regulatory amed M H H3) perwns po . ens byproduct matenat in

'" d 31 Flexibility Act,5 U.S.C. 005(b). the NRC cja I3[d at sede

""d 'e l61 h'$'y"5 Ms;n ragsegn , ,

certifies that,if promulgated, this rule Stat. 948. as amended (42 U.S.C. 22o1(i,h and transfer that matenalin accordann with the will not have a significant economic il 31.5 (cH4). (5). (6). and (11). 31.6 (dHf). labelins reqmremenu of I sts la effect on lanwy impact on a substantial number of small and 31.11(b) and (e) are issued under sec. u.197s.

"~_ _ _ _ _ . _ _ - - - _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

j

l **

l Feder:1 Register / Vol. So, No. 249 / Frid2y, D:cember 27, 1991 / Propc,xd Rules 67015 l

l number of devices, t pe of isotope, and Regianal Office listed in Appendix D of use under the generallicense in i 31.5 of wh3 has performed hat service on the part 20 of this chapter at least 3 working this chapter. The report must be d;vice since the last report concerning days prior to engaging in such activities provided either in the format presented ,

th) device was submitted to the NRC. In Non. Agreement States. The in subpart E. I 32.310. " Transfer Report (iii) Name, title, and telephone number notification shallinclude the date and Fornat " or on a clear and legible record of the person who is responsible for the location of the activity that will be as lor g as all of the data equired by the des tec and for ensuring compliance with performed. Prior notification does not form a t is included. If one or more tha appropriate regulations and apply in cases where a radiological intermediate persons temporarily rsquirements. hazard due to an accident or possesses the device at the intended (iv) Address at which the device is malfunction of the device axists. place of use prior to its possession by loc.:ted or used. the user, the report must include the (v) Whether the requirements of PART 32-SPECIFIC DOMESTIC same information for each intermediary I 31.5(c)(1) through (c)(10) have been LICENSES TO MANUFACTURE OR as in subpart E. I 32.310, and clearly mit. TRANSF".R CERTAIN ITEMS designate that person as an

. . . . . CONTAINING SYPRODUCT MATERIAL intermediary. lf no transfers have been

5. Section 31.0 is amended by revising 8. The authonty citation for part 32 made to persons generally licensed tha section heading and the introductory continues to read as follows: under i 31.5 during the reporting period, p:r: graph and by adding paragraphs (a), the report must so indicate.The report Au Sus.si,1e1.ta2.1s3.esStat must cover each calendar quarter and (d)- (2) and (f) to read as follows- 935,94a. 953. 954, as amended (42 U.S C. 2111.

2232, 3 c. 1. 88 Stat.1242, as must be filed within 30 days of the end

$ 31.8 Generaillconee to estrtlouta,inman, of the calendar quarter.

• • ** " '" For the purposes of sec'. 223. es Stat. 958, as (b) Report quarterly to the responsible I amended (42 U.S.C. 2273): il 32.13,32.15 (s), Agreement State agency all transfers of Any person who holds a specific (c), and (dl, 32.19, 32.25 (a) and (b). 32.29 (a) such devices to persons for use under a lic;nse by an Agreement Stsie and (b). 32.54. 32.55 (a) (b) and (d). 32.54. general license in an Agreement State's "ithorizing the holder to manufacture, 32.59. 32.62, and 32.210 are issued under sec. regulations that are equivalent to i 31.5.

Vibute, inst 611, or service devices 161b, es Stat. 944. as amended (42 U.S C. 2201 The report must be provided either in oescribed in 4 31.5 within the Ibil;andil 32.12, 32.1a, 32.20, 32.25(c),

32.29(cl. 32.51a. 32.52,32.56, and 32.210 are the format in subpart E, 6 32.310, Agreement State is hereby granted a .. Transfer Report Format," or on a clear e at 950, u gin:ral license to distribute, install, or I",'d

, nhd 1

and legible record as long as all of the service the devices in any non* data required by the format is included.

Agreement State for an unlimited period 7. Section 32.51a is amended by lf one or more intermediate persons of tirne and a generallicense to adding paragraph (c) to read as follows: temporarily possesses the device at the distribute, install, or service the devices Intended place of ose prior to its in offshore waters, as defined in 132.51a Same: Constione of Heenaea.

. . . . . possession by the user, the report must i 150.3(f), provided that: include the same information for each (s) The Agreement Siste licensee files (c) Furnish the individuals identified intermediary as in subpart E, 6 32.310, th3 a p opriate transfe* reports as under I 31.5(c)(11) or i 316(d) with and clearly designate that person as an requ y paragrN as (a) an () wr tien instructions and phecautions necessary to ensure safe installation, intermediary. If no transfers have been operation, and service of the device, made to persons gent: tally licensed under i 31.5 during the reporting period, These instructions must inciude the d (d) The person shall furnish a copy of the report must so indicate. The report tha general license contained in i 31.5 of leak. testing requirements, transfer and must cover each calendar quarter and this ch. apter to each person who is reporting requirements, disposal options including possible costs, and reporting must be M wWn hys oW ed ses onsible for the byproduct material of the calendar quarter.

En for ensuring compliance with the requirements for lost or damaged (c) Keep records of all transfers of appropriate regulations and such devicesas for each general licensee requirements. devices

8. St $ tion 32.52 is revised to read

[og]ows.' and in compliance with the above (e) The person shall provide the reporting requirements of I 32.52.

Individual responsible for service of the I 32.52 Same: Matertal transfer reporta Records required by this section must be device with written instructions and and records, maintained for a period of 5 years from precautions necessary to ensure its safe' Each person licensed under i 32.51 or the date af the recorded event.

installation operation, and service. I 31.6 to initially transfer devices to 9. Subpart E, 6 32.310 is added to to These instructions shall:nclude leak- generally licensed persons shall: CFR part 32 to read as follows:

tetting requirements, transfet and (a) Report quarterly to the Director of reporting requirements, disposal the Office of Nuclear Material Safety Subpart E-Report cf Traasfer of options, including possible costs and and Safeguards, U.S. Nuclear Regulatory Byproduct Materials reporting requirements for lost or Commission, Washir.gton, DC 20555, damaged devices. 9 32.310 Transfer Report Format.

and send a copy of the report to the (f) The person performing routine appropriate NRC regional office listed in This section contains the format service / installation or relocation of appendix D of part 20 of this chapter all required by i 32.52.

d2 Vices shull nohfy the appropriate NRC transfers of such devices to persons for auma coot reso.ai.es

67016 Federal Regist:r / Vol. So, No. 249 / Friday. Dec:mb:r 27.1991/ Propos2d Rules Subpart E-Report of Transfer of Byproduct Materials Section 32.310 - Transfer Report Format NAME OF VENDOR AND LICENSE NUMBER REPORTING PERIOD FROM TO GENERAL LICENSEE INFORMATION COMPANY NAME, STREET, CITY, DEPARTMENT

- STATE, ZIP CODE PERSON RESPONSIBLE FOR CONTROL OF THE DEVICE 4AME AND TITLE TELEPHONE NUMBER FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE '

, ACTIVITY AND UNITS NUMBER NUMBER l

e

~w 98Lutee CODE 79%41-C

._s.. . . _ . _ _ . _ _ . . _ .m_ _ _ _ _ . __ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

.~ .

1 l Federd Register / Vol. So, No. 249 / Friday, December 17, SW1 / Proposed Roles 57017

, Suyect airements for the 1 Possesskm of trialDevices  ;

Cont:Inhag 4p:M Material (RIN 3150-ADM).

Deted et Rocb416e, Marytend this 12th des of Dec:aber teet, ,  ;

For the Nuclear Reyvtetery Commisrion. -

Jeanee M.Teylor,  !

Esecutive Directorfor Operations.

IFR Doc. Skoos:t9 Filed 12-2tMit; a 45 aml ,;

natnee cosa reso4Hs -

M

-. -