ML20217L759
| ML20217L759 | |
| Person / Time | |
|---|---|
| Issue date: | 08/27/1991 |
| From: | NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML20217L002 | List: |
| References | |
| FRN-56FR67011, RULE-PR-31, RULE-PR-32 AD34-1-053, AD34-1-53, SECY-91-275, SECY-91-275-01, SECY-91-275-1, SECY-91-275-C, NUDOCS 9708190040 | |
| Download: ML20217L759 (33) | |
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August 27, 1991 SEcY-91-275 (NEGATIVE CONSENT) far: The Commissioners f_ts: James M. Taylor, Executive Director for Operations Sub.iet t : PROPOSED AMENDMENTS TO 10 CFR PART 31, " GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL," AND 10 CFR PART 32,
" SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL"
Purpose:
To obtain Commission approval for publication of a frital Reaister notice for the proposed amendments. Summary: In May 1990 the staff submitted a Commission Paper (SECY-90-175) which responded to a staff requiremt.its memorandum dated October 3, 1989 concerning the adequacy of oversight of generally licensed material. The Commission agreed with the staff recommendations in SECY-90-175 and directed the staff, among other thugs, to establish a registration and response system for general licensees. The attached rulemaking package responds to that request and would require general licensees who posses certain measuring, gauging, or controlling devices to provide the NRC with information about the identification of devices and the people responsible for these devices. The resources needed to implement the proposed rulemaking can be accommodated from within current resources shown in the Five Year Plan. Backaround: Between 1984 and 1986, the staff conducted a 3-year sampling, both by telephone calls and site visits, to determine the extent of compliance with the regulations which apply to the general licensees. Based on the sampling, the NHSS staff concluded that there was a general lack of awareness of the appropriate regulations on the part of general licensees and that there was an inadequate handling and accounting for generall.y-licensed devices. The impetus for the study in part was a number of incidents of improper use or disposition of generally-licensed devices. The staff believes these incidents were the result of NOTE: TO BE MADE PUBLICLY AVAII.ABLE UHEN THE FINAL SRM IS MADE AVAILABLE 9708190040 970812 b 56 67011 PDR
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4 . e a l l lho Conmissioners 2 ignorsnce of the requirements and responsibilities for possession of these devices on the part of general licensees evidenced by the study. Although no significant public health and safety hazards resulted from these incidents, otherwise avoidable exposures did take place. Between 1985 and 1990, contamination incidents involving licensed material cost an average of $750,000 per year in cleaning up and dispusing of contaminated material. On May 14, 1990, the staff submitted a Commission paper (SEcY 90-175) which responded to the staff requirements memorandum (SRM) dated October 3, 1989, concerning the adequacy of regulatory oversight of generally-licensed materials. In SECY 90-175, the staff identified certain generally-licensed devices that should be controlled through the specific licensing program. These devices are gamma gauges that of nee m sity are configured with a large air gap such that a wo-ker auld place a body part directly in the radiation beam. i staff indicated its intent to initiate a separate rulen.mng dealing with these devices. The staff also identified in SECY 90-175 several types of devices which appear to be suitable for exemption from regulatien. These devices include static climinators containing krypton-85, beta backscatter devices, gas chromatographs containing nickel-63, x-ray fluorescence analyzers containing cadmium-109 and iron-95, and calibration and reference sources with small activities. Hisuse or improper disposal of these devices would have a minor impact on aublic health and safety. Establishing exemptions for tiese devices could eliminate the need for up to 10,000 general licenses and 700 specific licenses. However, in accordance with Commission direction, staff plans to initiate rulemaking under the Commission's BRC policy for devices that appear suitable for exemptions have been suspended pending the outcome of the cons (nsus building process. With regard to the remaining larger group of devices for which neither exemption nor specific licensing appears appropriate 1 the staff stated that it intended to develop a rule charx aimed at ensuring proper regulation of these generally-licensed devices. The Commission concurred with the staff recommendations of SECY 90-175 and, by SRM dated August 13, 1990 (Enclosure 1), directed the staff to proceed with these rulemakings, and in particular, "to establish a registration and response system for general licensees...." This rulemaking package has been developed in response to that SRM.
The Commissioners 3 Discussign: There are approximately 35,000 general licensees who possess an estimated C00,000 devices containing byaroduct material regulated under 10 CFR Parts 31 and 32. Tle proposed amendments (Enclosure 2) have been developed to ensure that the general licensees are aware of and understand the requirements attendant to possession of these devices. This will be accomplished through (1) an initial verification by the NRC staff of the information regarding the identification of the device and aeo)1e responsible for the device collected at the time it w11c1 the general licensee takes possession of the device, and (2) periodic follow-ups by the staff to remind general licensees of their regulatory responsibilities and to verify the currency of the information on possession and use of these devices. The staff believes that increased awareness and understanding of the regulations on the aart of general licensees will increase the likelihood t1at they will comply with the Commission requirements for a generally-licensed device. Compliance with regulations will ensure that these devices are properly handled and accounted for and not inadvertently or improperly discarded, thereby reducing the potential for unnecessary radiation exposure to the public. Although, as discussed in SECY 90-175, the potential health and safety impact from the misuse or improper disposal of generally-licensed devices was assessed to be small, the inadequate accounting of such devices evidenced in the 3-year sampling adds an uncertainty to the determination of the actual risk. Through the proposed amendments, the NRC should be able to gather information that would confirm that the risk is indeed low, and provide a basis for confidence that generally-licensed devices are being handled and regulated in an appropriate manner. The proposed changes in Parts 31 and 32 are summarized as follows: Section 31.2, ' Terms and Conditions" - each general licensee would become subject to 10 CFR 30.9 which imposes requirements regarding the completeness and accuracy of information submitted to the Commission by licensees. Section 31.5, "Certain Measuring, Gauging, or Controlling Devices"- all references to specific licenses issued by Agreement States which authorized distribution of devices to persons generally-licensed by Agreement States would be deleted, and general licensees would be required to provide NRC with information about the devices and the people responsible for the device under provisions of a general
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t 4 The Commissioners 4 license. This would include the name and telephone number of the person res)onsible for controlling the use of the device, address w1ere the device is located, and whether the specific requirements of Section 31.5 have been met. Section 31.6, " General License to Distribute, Install, and Service Devices Generally Licensed in S 31.5" - removes the time limitation of 180 days placed on the specific licensee for distributing, installing, or servicing devices in non-Agreement States, in addition, it would impose information transfer and reporting requirements upon specific ilconsees from an Agreement State who have a general license to distribute devices to general licensees in non-Agreement States. As a result of these modifications and a previous omission, the title of S 31.6, is being modified to include the words " distribute and service." In addition, S 31.4, "Information Collection Requirements: OMB Approval, "would be mcdified to include the information collection requirements added to S 31.6 in the OMB approved list of information collection requirements fer Part 31. Section 32.51a, " Conditions of Licenses" - would require specific licensees to provide users of generally-licensed devices with written instructions, precautions, leak testing requirements, transfer and reporting requirements, and disposal options in order to ensure that devices are used safely and are properly transferred. Section 32.52, " Material Transfer of Reports and Records" - would require the distributor of a device, a specific licensee, to use a prescribed new format, or to provide all of the information required by the format on a clear and legible record, when submitting a transfer report to the NRC. The new format requests more detailed and complete information about the general licensee to whom the device was transferred than currently requested in S 32.52. Resources: Promulgation of this rule will involve both development and implementation, and operation costs for the NRC. The one-time development and implementation costs are about $63,000 and not considered to be a major factor in implementing the rule. Details of these costs are contained on pages 21 and 22 of the enclosed Regulatory Analysis (Enclosure 3). The operation costs include distributing notit. cations to and retrieving responses from general licensees and updating the tracking system for generally-licensed devices. The distribution and retrieval costs are estimated to be about 0.9 FTE per year based upon sending initial notices and periodic verification notices to selective groups of general
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, 4 The Commissioners 5 licensees based upon safety significance. Each year, notices will be sent to about 9,500 general licensees. ,
These notices would be dispatched based upon the )otential i hazard of the devices. Thus by the end of the titrd year about28,500ofthepotential35,000generallicenseeswould have been contacted. This means that with only a few i exceptions (beta backscatter gauges in microcurie.e. calibration / quantities, , quantities, and static eliminators containing Po-210) all ' general licensees will have been contacted by the end of the third year. Periodic notices would then be started after the initial notices have been sent to general licensees. . The frequency of the periodic notices will be determined based on the results of the first round of notices. The draft FY 1992-1996 FYP includes 3.5 FTE and $600K in Fiscal Year 1992 and 2.5 FTE and 5600K in subsequent years for NMSS to track general licensees, maintain records, manage contracts to test the safety features of device designs, perform a mail survey, and perform limited followup by telephone or letter. The operation costs also include inspection and enforcement followup to problems surfaced during the notification and retrieval process. Based upon the pilot General License Study and experience with specific licensees, the staff estimates that it will need to follow-up the mail surveys with telephone contacts in approximately 15% of the cases or about 1400 general licensees per year. These calls would be prioritized based on the potential hazard of the devices. The staff expects that these calls would reduce the number of licensees that would require regional inspections to a about 400 to 500 per year. ine staff estimates inspection costs for followu) on the 400 to 500 cases per year to be about 4.5 FTE eac.) year for the regions. The current budget includes 3 FTE each year beginning in Fiscal Year 1992. Thus, there is a shortfall of 1.5 FTE which will be accommodated by internal reprogramming from non-core activities. The Regulatory Analysis estimates there will be about 75 escalated enforcement actions per year as part of the
- followup to the violations identified during the notification and retrieval process (page 24). The staff recognizes it-will need to revise the program for handling enforcement in order to handle this additional load within current resourcas. At the time of the final rulemaking on this matter, the Commission intends to provide for an interim enforcement policy to supplement the current
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t & The Commissioners 6 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 Cnforcement Policy significant violations such as those involving lost sources may result 4 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 deficiencies are found. However, enforcement action will be considered for violatiuns involving the failure to provide the information requested or take 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 general license. Recommendation: Unless the staff is instructed to the contrary within 10 days from the date of this paper, the enclosed amendments to 10 CFR Parts 31 and 32 will be issued as a proposed rule. {oordination: The Agreement States have participated during the development phase of the proposed rule and their comments were incorporated as appropriate. The Offices of Governmental and Public Affairs, Nuclear Mater.1 Safety and
t ie C,wnedmn 7 h Safeguards Enforcement, and Administration concur with the ! contents of this paper. The Office of the General Counsel : has no legal objection. ,
, - /
b& J nes M. T or xecutive Director for Operations ;
Enclosure:
-1. Staff Requirements Memo (August 13,1990)
- 2. - Federal hgister Notice
- 3. Draf t Regulatory Analysis
- 4. Congrossional letters-4 SECY NOTE: In the absence of instructions to the contrary, SECY will notify the staff on Thursday, September 12, 1991, that the Commission, by negative consent, assents to the action proposed in this paper.
DISTRIBUTION: Commissioners OGC OCAA OIG GPA REGIONAL OFFICES EDO SECY
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I Enclosure 1 Staff Requirements 11emo 9
# 'o UNITED STATES ACTION - Beckjord, RES/ ,
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#'n NUCLEAR HEGULATORY COMMISSION )
.l W AS6HN OT ON, D.C. 2066s CyS: Taylor
%, ,. August 13, 1990 n
CFF6CE of THE OO stentiany Jordan, AE00 ! Scroggins, OC l MEMORANDtT., FOR: Jane M. Taylor SBaggett, NMSS j SMoore, HMSS Executive Director for O st kons FROM Samuel J. Chilk, Socrata: > SUDJECT: SECY-90-175 - STAFF REQU: M NTS - OCTOBER 3, 1989, FOLloWING A BRIEFI! ON STUDY OF ADEQUACY OF REGUIATORY OVERSIGHT OF MATERIALS UNDER A GENERAL LICENSE r; This is to advino you that the Commission (with all Commissionors agrooing) has concurred in the staff's recommendations. The staff should proceed with the rulomaking to modify the general licenso in 10 CFR 31.5 and to establish a registration and responso system for general licensoos through the proposed rulemaking. The periodic verification lotters provided for in the rule should be accompanied by a copy of the regulations from time to timo. Those actions should promoto better tracking, improved communications, and enhanced licensco understanding of the requirements and compliance with them. Staff should prepare and submit a proposed rule for Commission review.
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-{EDC>P (RES) (SECY Sucponse: M/1/^ 0 F gggggg, The staff should also proceed with a rulemaking to modify 10 CFR 32.51 to restrict the maximum air gap betwoon the device and the product for generally licensed devices. -A proposed rulo should
/ be prepared and submitted for Commission review.
Y
-(EDOt (RES) (SECY suspense 3/29/91) 9000192 As a separate but related matter, staff should proceed with intentions to estab ish through rulemaking separato exemptions for certain devices. Staff should ensure that proposed exemptions of cortain devices that are currently used under
\g. Nv general and specific iconses are analyzed and exempted in accordance with the Dolow Regulatory Concern policy. The staff should integrato its proposal to considor exempting these devices into the BRC implomontation program.
-(EDO)- (NMSS) (SECY Suspense: 9/14/90) 9000193 SECY NOTE: TilIS SRM, Tile Sulk 7ECT SECY PAPER, AND THE VOTE SHEETS OF COMMISSIONERS ROGERS, CURTISS, AND REMICK WILL BE MADE PUBLICLY AVAIlABLE IN 10 WORKING DAYS FROM Tile DATE OF THIS SRM. "
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s a 2 The staff should conduct reviews and analyses, as described below, and report findings to the commission.
- 1. Given the staff's belief that losses of generally licensed devices are underreported, it is likely that some kinds of accidents and misuses might also be underreported. The staff's recommendation for periodic verification letters itself indicates a concern that some general licensees might not know what problems they are required to report, or even that they are required to report. The staff should present the information obtained through these periodic surveys to tdus commission, with an evaluation of the need for further regulatory action. This evaluation should consider the need to require a specific license for additional types of devices or applications, to provide additional guidance to general licensees, for changes in the verification letters, and for other changes to part 31, such as a requirement for additional training.
- 2. The April 1987 report by Oak Ridge Associated Universities entitled " Improper Transfer / Disposal Scenarios for Generally Licensed Devices" suggests a potential for significant doses from several types of devices. Although the staff has informally determined that this document is based on unrealistic assumptions that produce dose estimates that are too conservative, the staff currently has no documented analysis supporting its conclusions.
The staff should explain why the doses estimated in the Oak Ridge report are unlikely to be experienced in practice or otherwise insufficient as a basis for rulemaking. To support its conclusions, the staff should obtain a peer review of the Oak Ridge report and analyze the potential doses associated with radioactive materials under a general license. Staff should use its analysis as a major part of the basis for making future improvements in regulatory oversight of general licensos and for making decisions on whether to recommend specific licensing for other generally-licensed devices. The staff's analysis could also provide a basis for gathering additional information on categories of general licensees where survey responses are sparse. This analysis should be independent of the proposed rule on the registration and response system, however, so that the rulemaking will not be delayed.
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- 3. The staff should assess the design dose criteria established for generally licensed devices in 10 CFR Part 32 to ensure that members of the public are adequately protected. In the recent Commission deliberations on final revisions to 10 CFR Part 20, Commissioner Curtiss raised a concern about adoption of 10% of the occupational limit (i.e. 500 mrem /yr) as the design criterion for generally licensed devices in 10 CFR 32.51(a) (2) (ii) and 32.51(c) . Rather than delay promulgation of the final revisions to 10 CFR Part 20 and the conforming changes, this issue should be resolved as part of an integrated program to improve regulatory oversight of generally licensed material and devices. Staff should carefully consider what the design criteria should be, given that the people receiving the exposures are members of the general public rather than radiation workers, and should provide recommendationr for the Commission's consideration on whether revision of the design criteria should be initiated.
The staff should submit a plan with milestones for the accomplishment of these reviews and analyses.
-f EDo)- (NMSS) (SECY suspense: 2/1/91) 9000194 cc: Chairman Carr Commissioner Rogers Commissioner Curtiss Commissioner Remick OGC GPA e
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l' 1 i. l i a i-l i I l-l- i a f Enclosure 2 federal Register Notice i I i i l i i I' l i l', p i i ) l .. 1 l ': i' 1 i l- i
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[7590-01) FEDERAL REGISTEk NOTICE NUCLEAR REGULATORY COMMISSION 10 CFR Parts 31 and 32 RIN 3150 - AD34 Requirement for the Possession of Industrial Devices Containing Byproduct Material 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, 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, distributors of generally licensed devices under 10 CFR Part 31.5-(specific. licensees) 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 attendant to the. possession of devices containing byproduct 1 Enclosure
1 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 l result in unnecessary radiation exposure to the public. ! DATE: The coment period expires 75 days after publication. Coments received after this date will be considered if it is practicable to do so, but the NRC is able to ensure consideration only for coments received on or before this date. ADDRESSES: Mail written coments to the Secretary, U.S. Nuclear Regulatory Comml>sion, Washington, DC 20555, Attention: Docketing and Service Branch. Deliver coments to One White Flint North,11555 Rockville Pike, Rockville, MD, between 7:30 am ani 4tl5 pm on weekdays. Copies of the draft regulatory analysis, as well as copies of the coments recalved on the proposed rule, may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. FOR FURTHER INFORMATION CON 1ACT: Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555, telephone (301) 492-3795. 2 Enclosure
SUPPLEMENTARY INFORMATION: Backgrcund . 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 conditions for 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 upon a determination 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 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 -f user is not necessary. 3 Enclosure
i l Discussion ! l i There are about 600,000 devices containing byproduct material in use by about 35,000 Itcensees 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 '- , integrity of the source capsule. Nonetheless.-there have been a number of occurrences where radioactive material has not been properly handled or disposed of resulting in radiation exposure of the public. Although no significant public health and safety i hazards'resulted from these incidents, had proper handling and disposal procedures 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. - 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 m __ _ _ . , __
0
- l storage of devices in warehouses, disposal in scrap yards, incineration of j waste, melting in a smelter, and disposal in a landfill, included in the risk i 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 ,
i 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 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 provides the basis for the regulatory changes proposed in this action. The rule would be a matter of compatibility for the Agreement States. The Agreement States participated in the development of this rule. Copies of the proposed rule 5 Enclosure
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were circulated to the Agreement States. They have supported the rulemaking and all of their comments were considered and incorporated as appropriate. The risk assessment and the sampling above also led the Commission to conclude that for a small group (a few hundred) of generally licensed gamma gauges the radiation risk, though small in an absolute sense, may be sufficient to warrant their conversion to specific licenses. In addition, there also appears to be another, larger group of generally licensed devices (about 10,?00) where the radiation risk is estimated to be very low. These devices, e.g., beta backscatter gauges and analytical devices may be candidates for exemption from further regulation under the Commission's BRC Policy. The Commission is considering these actions. This proposed regulation addresses the vast majority of generally licensed devices that fall in the middle of the risk spectrum, for these devices, the risk is small to the extent that specific licensing can not be justified. But neither is it so small, especially in consideration of the very large numbers of such devices extant, that exemptions would appear to be appropriate. An estimated 35,000 persons use certain measuring, gauging, or 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 provisiens 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
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 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 revis>>ns a new paragrapn (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, 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 1 rcferences to specific licenses issued by Agreement States that authorize distribution of devices to persons generally licensed by Agreement States. At present, 10 CFR 31.6, " General license to install devices generally 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. 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 i restriction for i 31.5 licenties. This change will be convenient to the NRC,
?- Enclosure
Agreement States, and manufacturers because it will reduce-and simplify paper work without increasing the risk to public health and safe'*. Proprsed para-graph 31.6 (a) would require the general licensee holding a specific license from an Agreement State to report to the NRC all persons rcceiving a device from the licensee, as specified in the accompanying proposed revision to i 32.52. Proposed paragraph 31.6 (d) would require that licensee to supply , each of the recipients of a generally licensed device a copy of the general license contained in i 31.5. Proposed paragraph 31.6 (e) would require that written instructions and precautions be provided to persons servicing a generally licensed device. Proposed paragraph 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 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 nntification 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." 10 CfR 32.51a, " Conditions of licenses," presently imposes conditions on applications for a specific license to manufacture or initially transfer generally licensed devices to general licenses. The tddition of proposed paragraph (c) to i 32.51a would require such specific licensees to provide recipient users of generally Itcensed devices with written instructions and - precautions to ensure that the devices are used safely. In addition, these 8 Enclosure
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specific licensees would be required to provide those users with information regarding testing requirements, transfer and reporting requirements, and disp %al optiora for the devices being transferred. 10 CFR 32.52, " Material transfer reports ar.d records," currently requires specific licensees authorized to distribute devices to general licensees to file transfer reperts with th$ NRC on a quarterly basis. The revised regulation would prescribe the fo met to be used when submitting transfer ' reports to t.he NRC. The proposed format will provide more detailed and complete information about the gNwal licensee to whom the device is transferred. The format is presented in proposed Subpart E of Pan 32, 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. In addition, specific licensees would be required to identify a persor. 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 who received the devices during the preceding reporting period and ask 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 5 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 9 Enclosure
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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 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 nominal (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 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 actin 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 10 Enclosure
. , t I
to identify deficiencies caused by a concern of potential enforcement action. This action woulo 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 , 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 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 Exclusion The NRC has determined that the proposed rogulations are the type of action described in the categorleal 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. 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 approva 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
t 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 burden, to the Information and Records Management Branch (HNBB-7714), U.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, Weshington, 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 Nucicar 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 12 Enclosure
receipts do not exceed $3.5 million over a 3-year period. The proposed rule affects about 35,000 persons using products under this general license, many of whom would be classified as a small entity. However, the NRC believes that the economic impact of the proposed requirements on any general licensee would be negligible. The proposed rule is being issuet to better ensure that the general licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession. . Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to these proposed rules and therefore a backfit analysis is not required because these proposed amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1). List of Subjects in 10 CFR Parts 31 and 32 10 CFR Part 31 i Byproduct material, Criminal penalties, labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment. 4 Y 13 Enclosure
. 1 l c -.
10 CFR Part 3r - Byproduct material, Criminal penalties, Labeling, Nuclear materials, l Radiation protection, Reporting and recordkeeping requirements, and Scientific
. equipment-For the reasons set out--in the preamble and under the authority of the
- Atomic Energy Act of 1954, as amended, the En6rgy Reorganization Act of-1974, as amended, and 5 U.S.C. 553, the NRC is-proposing to adopt the following- l amendments to 10 CFR Parts 31 and 32:
- c. PART 31 - GENERAL DOMESTIC LICENSM FOR BYPRODUCT MATERIAL
- 1. The authority citation for Part 31 is revised to read as follows:
Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat.1242, as amended, 1244 (42 U.$.C. 5841, 5842). Section 31.6 also issued under sec. 274, 73 Stat 688 (42 U.S.C. 2021). i for the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
$531.5(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 31.11(b) and (e) are ; issued under sec. 1610, 68.St'at. 950, as amended (42 U.S.C. 2201(o)). i
- 2. Section 31.2 is revised to read as follows: 5 31.2 Terms and conditions.
14 Enclosure
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The general licenses provided in this part are subject to the provision ' ofSS30.9,30.14(d),30.34(a)to(e),30.41,30.51to30.63,andParts19, 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 Information collection requirements: DMB approval.
- (b) The approved information collection requirements contained in this part appear in SS 31.5. 31.6, 31.8, and 31.11.
- 4. In 5 31.5. paragraph (b) is revised and paragraph (c)(ll) is aJded to read as follows: 5 31.5 Certain measuring, gauging, or controlling devices.'
(b) The general license in paragraph (a) of this section applies on1.v to byproduct material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications L 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 t
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 L _ _
(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 Itcense. 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 dovice was submitted to the NRC.
(iii) Name, title, and telephone number of the person who is responsible for ti.e 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 S 31.5(c)(1) through 31.5(c)(10) have been met.
- 5. Section 31.6 is amended by revising the section heading and the introductory paragrap5 and by adding paragraphs (a), (d), (e), and (f) to read as follows:
5 31.6 General license to distribute, install, and service devices , generally licensed in S 31.5. Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, distribute, install, or service devices 16 Enclosure
o . described in 5 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 5150.3(f), provided that: (a) The Agreement State licensee files the appropriate transfer reports ar. required by paragraphs (a) and (b) of 5 32.52. (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. (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 Rec,ional 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 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. 17 Enclosure
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 under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(c)).
- 7. Section 32.51a is amended by adding paragraph (c) to read as follows:
5 32.51a Same: Conditions of licenses. (c) Furnish the individuals identified under S 31.5(c)(11) or S31.6(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:
S 32.52 Same: Material transfer reports and records. 18 Enclosure
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 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 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 of Part 32 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 persona 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 repott must cover each calendar quarter and must be ffled within 30 days of the end of the calendar quarter. (b) Report quarterly to the responsible Agreement State agency all 4 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
l I 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. (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. Subpart E (Section 32.310) is added to 10 CFR Part 32 to read as follows:
Subpart E - Report of Transfer of Byproduct Materials S 32.310 Transfer Report Format. This section contains the format required by 5 32.52. 20 Enclosure
t 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 3ERSON RESPONSIBLE FOR CONTROL OF THE DEVICE NAME AND TITLE TELEPHONE NUMBER FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY AND UNITS NUMBER NUMBER
- - - - - . - . ~ _ - _ _ _ . _.
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. James H. Taylor, Executive Director for Operations. l 22 Enclosure
t Enclosure 3 Draf t Regulatory Analysis
-4 4
.ARGONNE NATIONAL LABORATORY 9700-South Cass Avenue, Argonne, Illinois 60439 DRAFT REGULATORY ANALYSIS:
REQUIREMENTS FOR POSSESSION OF DEVICES CONTAINING BYPRODUCT MATERIAL by Philip H. Kier Environmental Assessments and Information Sciences Division and Joseph J. Mate U.S. Nuclear Regulatory Commission June =1991 work. sponsored by U.S. NUCLEAR REGULATORY COMMISSION-
' Office of Nuclear Regulatory Research
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CONTENTS t ABSTRACT.................................................................. 1 STATEMENT OF THE PR0BLEM............................................... 1.1 Background......................................................... 1.2 NRC Study of Conformity with General License Conditions. . . . . . . . . . . . 1.2.1 Part I Results............................................... 1.2.2 Part II Results.............................................. 2 0BJECTIVES............................................................. 3 ALTERNATIVES........................................................... 3.1 No' Change.......................................................... 3 ; 2 Mod i fy Reporti ng Requi rements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2.1 Knowledge of Conditions in General Licenses . . . . . . . . . . . . . . . . . 3.2.2-Verification of Conformity with General License Conditions...
- 4. CONSEQUENCES ..........................................................
4.1 Bene fi t s o f Al te rn ati ve 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 RATIONALE,.................................................... 6 IMPLEMENTATION......................................................... 7 EFFECT ON SMALL 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
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- 22 .a _.2..... ..M.- __, .wa - _..am.-nJ. a 6. - - - .
. 4 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 certain license conditions that must be complied with relating to the possession and use of these devices. Lack 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 occurred. 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 fra 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
l 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 regulatory 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 $437,000. 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 would improve the generat 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 cnd 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 v
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provide NRC.with the confidence-that generally 11 censed devices are being
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I I 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 Commission (AEC) amended its regulations to pr. 4de, 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 Commission's regulations apply only in "Non-Agreement States". An " Agreement State is one which has entered into an 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 tha Atomic Energy Act to have similar regulations to those of the Commission.) The devices must be manufactured in accordance with the specification contained in a specific license issued either by the Commission 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 l 1
2 license for possession and use of such devices. General licensees possess an estimated 600,000 devices to which Commission regulations apply. A general licensee, under the jurisdiction of the Commission or an Agreement State, is currently 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 reported. At present, the Commission is notified when possession of devices containing byproduct material is transferred from a Commission licensed specific licensee to any general licensee, through qurrterly reports submitted 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 Commission 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 9f 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 Com. ission within 30 days of the transfer.
l l 3 l I 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 insignificant but unnecessary exposure of the public to radioactive
'.t er i al , in fact the occurrence of a few such incidents led the Commission to conouct a study from 1984 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 devices covered under 10 CFR 31.5, the study was divided into two parts. The first part covered industrial gauging and measuring device , such as large-scale 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.
l.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 HRC regional offices. Some
. +
i i 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 largo-scale gauges, clearly established that there is a compliance 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 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 Il Results 3 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 the 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 4 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. Beta backscatter gauges contain a small sealed source and a radiation detector that measures how much radiation is reflected back from a material sample, m -v ----4 _+----
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 II are summarized below:
- Nonconformity with the general license conditions was very widespread.
e Only 16% of the general licensees for exit signs were aware of the regulatory requirements. e 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 reports of the manufacturers.
- Three cases involved missing sources from beta backscatter gauges.
e Only 45% of those surveyed for backscatter gauges were aware of the general license conditions.
- 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.
6 2 OBJECTIVES The objectives of the proposed revisions to Parts 31 and 32 of the Comission'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.
, i l
7 3 ALTERNATIVES The following sections describe the alternatives to be considered in this regulatory analysis. 3.1 NO CHANGE This alternative would continue the status quo by making no change in the current regulations governing devices containing byproduct material. 3.2 MODIFY 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 transferred properly and are not inadvertently discarded. The general m:chanism 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
. s 8
-proposcJ revisions would 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 the name and/or title of the individual'who constitutes the point of contact between the NRC, or the Agreeuent State agency, and the general licensee. The General License Study indicated that this individual, who is frequently in the purchasing department, ofte, did not inform the individual who uses the device of the general license conditions. Moreover
'high personnel turnover frequently destroyed the organization' 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 license transferee using the format depicted in the proposed-10 CFR 32.310. This-format calls for identification of the person responsible for meeting regulatory rcquirements associated witt, 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 tne 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.
9 Proposed subsection (c) of 10 CFR 32.5)a would also help ensure that users of devices are aware of-the conditions in the general license. It woule provide that the responsible user be furnished with written instructions and precautions necessary to ensure safe installation, operation, se: ice, and disposal of the d3vice. 4 3.2.2 Verification of Conformity with General License Conditions Currently, the only connunications 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 4 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 4 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. 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 fir' st 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-licensees of their regulatory responsibilities and to reduce the likelihood that devices contair,ing byproduct material are illegally transferred or inadvertently disposed of.
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10-NRC recognizes specific licensees 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
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4 11-4 CONSEQUENCES-The estimates of costs and benefits of the proposed revisions are based on the guidance found in NUREG/BR-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 used 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 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 impropei 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 dispo::ition of these devices, and thereby confirm both the assessment of low z__ +
o- .. I 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 C1) gauge was mixed in with scrap. The plant and about 51 Hg (100 tons) 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 m llion. 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. The decontamination cost was $600,000. In 1987, it 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 scales, it set off the radiation alarm. The contaminated flue dust, 40K lbs, was moved off-site for disposal. The cost of tne 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 railroad cars. Thus far the decontamination has cost 8ayou 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 which contains some rare elements, the steel
TABLE-1 TYPES OF COSTS LIKELY TO BE AVOIDED BY THE PROPOSED REVISION U " ^ ' P ^ F STATE YEAR COMPANY METAL ISOTOPE COST C OF TA LU D ST CA 85 Tamco Fe Cs-137 1.5 mill gauge in moved of f site scrap for disposal Steel 1.5 Ci US Pipe Fe C s-137 600K gauge in on-site At 85
& Foundry 10-50 mci scrap facility (forever)
Florida Fe Cs-137 250K gauge in moved of f site TN 87 Steel 20 mci scrap for disposal C LA 89 Bayou Fe Cs-137 50K- gauge in on site in Steel .5 Ci scrap RR cars PA 89 Cytemp Fe Thorium 100K mixed in contaminated Speciality rare steel buried Steel elements no flue dust UT 90 Nucor Fe C s-137 2 mill - gauge in Steel 200 mci or( site in scrap RR cars 1
- costs of disposal not included and will be subtantial as of 8/1990
I 14 was found to be contaminated. Some thorium was mixed in with the rare earth elements. The contaminated steel was sent to brokers for burial, and the 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) gauges were mixed in with scrap. 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 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 ALTERNATIVE 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.
15 4.2.1 Costs of Revisions to 10 CFR 31.5 The proposed revision would require general licenseer to respond to requests from the Commission for verification of information relating to their general licenses. This information would help the Commission verify the location of generally licensed devices containing byproduct materials and confirm compliance with the general license conditions imposed by its regulations. The Commission 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 that a general licensed device had been shipped. This request would cover only those licensees receiving devices shipped during that quarter. The Commission also would periodically send each general licensee a request for verification 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 Commission. 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 "Hondbook" 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 infarmation on this form into the directory. From NUREG/CR-4627, " Generic Cost Estimates", l
o . 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 't 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 sntered. 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 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 cost. 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 annual cost of this step would then ba: Cost (step 2) quarters /yr x 5,000 shipments / quarter x
$1.29/ shipment = $25,800/yr.
Step 3. A general licensee would have to respond to the Commission's request for verification for those devices transferred to the general licensee
17 during the quarter. The General License Study found that the average time required to locata 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 tcke a general licensee about 15 minutes of staff time to comply. Assuming that the cost to industry of staff time is also $41/hr, the annual cost of this step, which is characterized by the
" Handbook" as an Indust y operations cost, is estimated as:
Cost (step 3) = 4 quarters /yr x 5000 shipments / quarter x
$10.25/ shipment = $205,000/yr Step 4. When the Commission receives a response from a general licensee, it will log in the response on the computerized directory or somehow record that verification has been received. It is assumed that the staff effort associated with this step costs approximately $1 per response (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:
"ost (step 4) = 4 quarters /yr x 5,000 shipments / quarter x
$1/ shipment = $20,000/yr Step 5. The Commission would mail periodic requests to general licensees to verify compliance with general license requirements for all devices in the possession of the general licensees. These periodic verification requests would repeat steps 2 through 4 but would differ from the initial verification requests in the number mailed annually. In this analysis, it will be assumed that one-third of the approximately 28,500
18 general licensees (9.500) under NRC's jurisdiction would receive a verification request annually. Although there are approximately 35,000 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 werial (i.e. calibration / reference sources in microcurie quantities, beta bactscatter gauges in micrucurie quantities, and static climinators containing Po-Z?1). 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 cho.ge at a later date, the general licensee is required to inform the NRC. It is estimated that about 100 such notices might occur snnually. The time to enter tha data from a licensee into the computer system is estimated to be ' bout 3 minutes per entry. A total of about 5 hours 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 possessios, 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 general licensees of responding to periodic verification requests is then: Cost (step 6) = 9,500 requests /yr x 541/hr x 0.5 hr/ request = $194,750/yr
\ l 19 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 minutes, giving a total of about 25 hours for all the requests. The total cost for all licensees is estimated to be $1,025. To summarize, it is estimated that the annual operations costs of the proposed revision of 30 CFR 31.5 are $400,775 for general licensees and
$67,380 for the Commission in undiscounted 1988 dollars. These costs do not include costs to the Commission of creating and maintaining a computerized directory of devices, which are consiuered sunk costs.
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 licensees issued by Agreement States. There are approximately 150 specific licensees in the United States, of which approximately 90 hold licenses issued by Agreement States and approximately 60 hold licenses issued by the Commission. Only the former are affected by the proposed revisions. Subsection (a). This new subsection would require holders of specific liceines from Agreement States to file with the Commission the Section 32.310 form for each shipment to a general licensee under NRC's jurisdiction. Currently, some Agreement State specific licensees send reports to the Commission voluntarily. There would be only negligible cost for these specific licensees to substitute the Commission's format. For the other 1
20 specific licensees from Agreement States, this subsection would impose a new 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 hours ($82) spent and postage of $4. It is assumed that this cost would apply for one-third (30) of the specific licensees in Agreement States. The annual cost of the new subsection would then be estimated at Cost (subsectiona)=30 reports /quarterx$86/reportx 4 quarters /yr - $10,320. 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 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 impicmentation cost. Approximately 38 vendors would expend about 16 hours each, or 608 hours at $41/hr for a total cost of $24,928. Subsection (d). This new subsection would require holders of specific licenses from Agriement States to provide general itcensee transferees with copies of the general license contained in 10 CFR 31.5, instead of the Agreement State license. The associated ccat 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 thh new subsection is then estimated to be:
21 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 1.icense Survey, which is the research in support of the proposed regulatory action, has already been perforraed 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 '
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22 4 1 i cost of one NRC professional staff is $74,000/ staff-yr. The component of NRC'S development 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 and ,
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 single 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 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 f 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 t 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 Enforcement Costs Enforcement costs are those costs incurred by NRC after it determines that a licensee.is not in compliance with the agency's regulations. The
23 Office of Nuclear Material Safety and Safeguards has indiccted that the proposed regulatory action may result in an increase in enforcement activities on the part of the NRC. Costs per enforcement action would likely remain unchanged, but the number of enforcement actions might increase 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 1.0 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, 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 gauge users are inspected, in about half of 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 .52) survey submittals with violations per year. This number is believed to be on the high side because specific itcensees tend to have more regulatory requirements to comply with than do general licensees.
l l 24 Based on an annual escalated enforcement rate l for lost devices of j 1.5% for specific licensees, it is estimated that about 75 general licensees might require escalated enforcement actions per year. Current practice of the i Office of Enforcement (OE) requires about 2 FTEs to process approximately 100 actions per year. Thus, the proposed rule would require an additional 1.5
- FTEs 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 1
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, such as Public Affairs and Congressional Affairs, that are involved in the enforcement action process. However, the total combined resource needs for these offices is estimated to be less than 0.2 FTEs. This workload can be absorted by the current staff. Using the estimates provided in " Generic Cost Estimates," NUREG/CR-4627 Rey, 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 percent discount rate. If one uses the 10 percent discount rate, ',he costs could range from $1.5 million to $2.3 million. 4 1 An escalated enforcement action is: a Notice of Violation for rny Severity level I, II, or til violetion; a civil penalty for a violation at any severity level; and any order based upon violations. w_. . . + . .=q ..,y ,...e., s.,,.m.a-..--m, - _ _.--.a---m .__._____.u._ m a m-- --
25 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 be estimated 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 will continue to be incurred as long as there is commerce in the subject devices, at current levels, with the proposed 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 value 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 are not a direct cost of this rulemaking. TABLE 2 Sumary of Costs to NRC and Industry of Proposed Changes Cost ($1000) Item Upfront Annual Present Value NRC development 59 NRC implementation 4 NRC operation 67 570 Industry operations General licensee 401 3413 Specific licensee 36 306 Industry implementation 25
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5 DECISION RATIONALE It is recommended that the proposed action be adopted because it represents a reasonable means for the Comission to fulfill its obligation to protect the public health and safety. 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 recomendation follows. The results of a survey conducted by the Comission indicated that there is noncompliance with the general license requirements contained in 10CFR31.5(c). Such noncompliance presents a risk of insignificant but 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 licensed 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 to ensure that general licensees are aware of the provisions associated with i the general license and ' comply with the applicable regulatory requirements. It is believed that increased awareness and understanding of the Comission requirements on the part of the general licensees will increase the likelihood 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
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e O 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 is estimated that adoption of the proposed regulatory action would result in upfront development and implementation costs to the Commission of
$63,000, annual cost 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 of a deviceoverthelifetimeofthemajorityofdevices(seeSection7). 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 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 cleanup costs which have occurred because of past improper disposition of generally licensed devices.
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28 6 IMPLEMENTATION The proposed regulatory action is not expected to present any significant implementation problems. The computerized directory that would be required has already been implemented by the Comission. The only action needed for implementation is that the Comission develop and mail an information notice to specific licensees to inform them of their new responsibilities under the amended 10 CFR 31.6. _ = _ _ _ _ .
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 entities" 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 be $205,000/yr. It is estimated that there are approximately 80,000 devices transferred from specific licensees to general licensees under the Commission's jurisdiction per year. 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 responding 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 cost to the general
, 1. 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. I The price of the generally licensed devices ranges from $185 to
$250,000. However, 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. 9 4 I i
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i 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 subcommittee is a copy of a Notice of > Proposed Rulemaking to be published in the Federal Reaister. 10 CfR Part 31 : estabitshes 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 ' > made in 10 CFR Part 32 on the transfer reporting requirements im)osed on persons authorized to distribute byproduct material. These c1anges are being made because there is inadequate accounting for generally licensed devices, and also a general lack of awareness of the appropriate regulations on the part of general licensees, it is anticipated that the proposed rules will ensure that these two problems aro remedied by more timely contact between the general licensee and the NRC. Sincerely,
. M Eric S. Beckjord, Di ector Office of Nuclear Re ulatory Research
Enclosure:
Notice of Proposed Rulemaking- , cc: The lionorable John J. Rhodes 1
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The Honorable Bob Graham, Chairman Subcommittee on Nuclear Regulation Connittee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Register. 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 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. These changes are being made because there is inadequate accounting for generally licensed devices, and also a general lack of awareness of the appropriate regulations on the part of general licensees. It is anticipated that the proposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC. Sincerely. O <7 i i d .
< W Eric S. Beckjord )irector Office of Nuclear egulatory Research
Enclosure:
Notice of Proposed Rulemaking cc: Senator Alan K. Simpson
f , .o o / gung %* UNITED STATES [' 3 m / *g NUCLEAR REGULATORY COMMISSION g a W AEHING T ON. D. C. 20665
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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 lulemaking to be published in the Federal Register. 10 CFR Part 31 establistes 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 ?2 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material. These changes are being made because there is inadequate accounting for generally licensed devices, and also a general lack of awareness of the appropriate regulations on the part of general licensees. It is anticipated that the proposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC. Sincerely. S. Eric S. Beckjor W jDirector Office of Nucle Regulatory Research
Enclosure:
Notice of Proposed Rulemaking cc: Representative Carlos J. Moorbead
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..... AD 34-l 4, UNITED STATES 8,
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.'- NUCLEAR REGULATORY COMMISSION wAsmo tow, p. c. mu P0R s, j m . , ,,,,
HLMORANDUM f0R: Joseph J. Mate Regulatory Development Branch Office of Nuclear Regulatory Research fROM: David L. Meyer Chief Regulatory Publications Branch . Division of freedom of Information l and Publications Services Office of Administration
SUBJECT:
REVIEW OF SECY-91-276 " PROPOSED RULE ON REQUIREMENTS
. FOR THE POSSESSION Of INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" ,
i The Regulatory Publications Branch (RPB) receives and reviews most Commission I Papers that discuss rulemaking actions or related items. We have reviewed - SECY-91-275 that presents the pro)osed rule on " Requirements for the Possession of Industrial Devices Containing Jyaroduct Material" for Connission consideration. We have enclosed a marked copy of t1e proposed rule that presents minor editorial and format corrections. These corrections should be made before the proposed rule is forwarded for publication in the federal Register. If you have any' questions regarding our consnents, please contact Micheal T. Lesar on extension 27758 or Alzonia W. Shepard on extension 27651.
/
David L. Meyer Chief Regulatory Publications Branch Division of freedom of Information and Publications Services Office of Administration
Enclosure:
As stated i e b0 .
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N'Qb '};L fO b~L -l c
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. [7590-01) i
- fCOEPAL PIC!$TCP, NOT!CE Y NUCLEAR REGULATORY COMHSSION i >
10 CFR Parts 31 and 32 t RIN 3150 - AD34 Requirement for the Possession of Industrial Devices Containing Byproduct Material 4 AGENCY Nuclear Regulatory Commission. ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Comission (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 othcr things, would require general licensees who possess these devices to provide the NRC information about the identification of devices and the people responsible for.
stes w.s.-t'.t ussta wuo b95. - the devices. Further^ distributors of generally licensed devicesGiidir 10 CTD- y
%m. J (Part 31 d issiecific' licensee would be-required to use a uniform format when
-submitting the quarterly transfer reports to NRC. The proposed rule is -
intended to ensure that gen w.1 licensees are aware of and understand the i NK- . y requirements (alttendant to)the possession of devices containing byproduct i 1 Enclosuro
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k PInud 0 material. Thisg:md rNlo rer,est wili p er assu /ry' 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 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 Commission, Washington, DC 20555, Attention: Docketing and Service Branch. 4 Deliver 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 FURTHER INFORMATION CONTACT: Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3795. Y e 2 Enclosure
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d I i l F l SUPPLEMENTARY INTORMATION: s r i
Background
l On February 12-1959(24FR1089),theAtomicEnergyCommissionamended :
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its regulations to provide a general license for the use of byproduct material ' contained in certain. luminous, measuring, gauging, and controlling devices.
. fw eegu of Under the curren* reggy=m
; orAa general license, certain personi may , l f ___._,.. j' j receive and use a device containing byproduct material-if-the device has been ,
b
. manufactured and distributed in accordance with the specifications contained !
in a specific license issued by the NRC o; by an Agreement State. A specific license is issued on determination by a regulatory authority that the t/ safety features of the_ device and the instructions for safe operation are i s adequate and meet regulatory requirements. The general licensee is required i 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 3 generally licensed device is a
- black box,' that h , the radioactive material l l' is contained in a sealed source usually within a snielded device. The device !
is designed.with inherent radiation safety features so~that it can be used by
. persons with no radiation training or exportance. Thusj the general license
- policy is a; mechanism to simplify.the license process si that a case-by-case '
1detemination of the. adequacy of the radiation training or axperience of each user is.not necessary.
- 3- Enclosure
._ , . . . . .- . - - ._. -. _ ,. ,,,,-. .a a.m,_-,,_,_...._.,.-..__.__,___,,.mx,,_.uJ-.
) Discussion s There are about 600,00 Y)*/g 1 l v o devicesjc',ntaingbyproduct material in use by about 35,000 licensees vnder the Commissio.'s p nern license regulatory program. General licensees have not been contacted by NRC on a regular basis because of the relatively small radiatioet 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 moltsn steel, and hit by construction vehicles with only ninor losses in radiation shielding while maintaining the integrity of the source capsule, gg Nonetheless, there have been a number of occurrences where radioactive Q,. t pL cl a material lias not been properly handled or disposed org result in radiation exposure of the public. Although no signific.nt public health and safety hazards res d edfromtheseincidents. gad # roper handling and disposal V 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 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 accountabilitv, as occurred above, remains the most frequent incident and the predominant dr.cern. - Because of these occurrences, the NRC's Office of Nuclear Material Safety and Safeguards (HMSS) conducted a radiological risk assessment addressing 4 Enclosure
I storage of devices in warehouses, disposal in scrap yards, incineration of waste, melting in a smelter, and disposal in a landfill.hneluded in the risk Y assessment incident at a stJel company in 1983 (discussed in NUREG-1188, 'The Auburn Steel Comp;r.y .7&dia.clive Contamination Incident") that probably represents a worst-case see ario for generally licensed gauging devices QY
^.iths;.l individual YoNn~t 4Vd doses were low and pyrs withina.;r::eripf=d
- n. , limits y b
y.fcme ct i for exposure of members of the public they ;;e.erth&!! 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 sar.,,Hng (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 kheuseofradioactivematerialunderthe / general licens provisions. On the basis of the sampling, the NRC concluded that there isg(l) r. lack of awareness of appropriate regulations on the part Tf the user (general licensee) and (2) inadequate handling and accounting for i these generally licensed devices. The NRC further concluded that these two iroblemscouldberemediedbymorefrequentandtimelycontactbetweenthe general licensee ar.d the NRC. This conclusion by the NRC provides the basis for the regulatory changes proposed in this action. The-rule-would-be-a-matter of-compatibilityJor. the-Agteement-StatesrThe-Agreement-States..
. partic,1 pated-irr-the-tievelopment of this rule-Copiedof-the-proposed rule h T N.J-6 R 'T '4 5 Enclosure
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Ng were circulated in .n3 .'reement States. They have supported the rulemaking N andalloftheircommentswereconsideredandincorporatedasfpkropriate. The risk assessment and the sampling above also led t [Comission to j wfu puun) conclude that for :. m:.11 g?sup (a few hundred) of gene f licens gama Adtre f' gaugesgtne radiation risk, though small in an absolu,te sense, may be sufficient to warrant their conversion to specific'Itcenses. In addition, ; i e [o powU - there also appears to be another, larger group'of general licens evices I (abow 10,000) where the radiation risk is. estimated to be very low. These 4 devices, e.g., beta backscatter gauges and analytical devices may be candidates for exemption from further regul i u er the Comission'h j Policy. The Comission is considering @ise adMonsp Thi:; proposed . i regulation addresses the vast majority of generally licensed devices that fall l
\
- in the middle of the risk spectrum. For these devices, the risk is small to i the extent that specific licensing can not be justified. But hbN #
small, especially in consideration of the very large numbers of such e vices j xtent, that exemptions would appear to be appropriate.
~
An estimated 35,000 persons use'certain measuring, gauging, or 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, D , 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 NRC t$mby V f
NT#Me's.wie Wdapemer:H k en m 6 Enclosure
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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)ofI31.4isbeingaanded v to add : 41.5 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 prop'osed 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; a 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 mct. - 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 distr: a ion of devices to persons generally licensed by Agreement States. 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 i 31.5. The currentregulation,10CFR31.6.isnoscloarwithrespecttotime 1
/0#4 5 0. * * , bJM restrictions. ' aragrap -.20-(b)(3)sf10CFRFari.15 imposes a 180-day-per-calendar-year. limitt ion 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
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Agreement States, and manufacturers because it will reduce and simplify paper work without increasing the risk to public health and safety.hr#oposed p:r:- V
/
g .aph 31.6 (a) would require the general licensee holding a specific license
~ - from an Agreement State to report to the NRC all persons receiving a device from the licem ee, as specified in the accompanying osed revision to i 32.52. Proposed 31.6(d)wouldrequire licensee to supply #
each of the recipients of a generally licensed device a copy of the general license contained in 5 31.5. Proposed r.p s 31.6 (e) would require that 7 written instructions and precautions be provided to persons servicing a generally licensed device. Propose r;;r;ph 1.6 (f) would also require a - person performing routine installation / servicing / relocation of these devices to notify the appropriate NRC regional office at least 1 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 5 31.5." Le ' 10 CFR 32.51a, "fonditions of licenses," presently imposes cond' u on /
/applica for a-specific license to manufacture or initially transfer /
generally licensed devices to general licenses. The addition of proposed paragraph (c) to 5 32.51a would require such specific licensees to provide recipient users of. generally licensed devices with written instructions and precautions h ensure that the devices are used safely, in addition, these 8 Enclosure
~o -_y
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 sutnitting transfer reports to the NRC. The proposed fornatNprovide more detailed and complete information about the general licensee to whom the devi e is transferred. The format is presented in proposed Subpart E[Nrt %, 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 legi-s 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 i 32.52, the NRC would send letters to the general licensees h i ll & 3 ye o received the devices during the preceding reporting period An)_ sik &M%
$ W t& Q o
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)(11)(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 tha*, they still have the device, verify the safety-related information, and remind them of their 9 Enclosure
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 gent al licensee would allow the NRC to validate and update the information current N .'ontained 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 nominal (on the order of
$10 per device). Accordingly, the Commission believes that the increased compilance 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 a
coments on this matter. At the time of the final rulemaking on this matter, the Commission 1 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 / 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 10 Enclosure
4 to idem try deficiencies caused by a concern of potential enforcement action. 1n t'on would be taken to encourage general licensees to search their p facticc1es to assure sources are located, to determine if applicable requircaents have been met, and to develop appropriate corrective action when deficiencies are found. However, enforcement action will be considered for i violations involving the failure to provide the information requested or take appropriate corrective actions or willful violations including the submittal of falso information. Sanctions in those situations may include c'ivil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a general license. Environmental Impact: Categorical Exclusion a The NRC has determined that nt' e proposed regulations are the type of action des:ribed 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 it.it peptred regulation. Paperwork Reduction Act Statement The proposed rule amends the infor1ation 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 11 Enclosure
f reviewing instructions, searching existing data sources, gathering ant' 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 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, NE0B-3019, (3150-00lG 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 rCysis examines the cost and benefits of the alternatives
' onsidered by th. W . 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 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 _ _ _ . _ _ . _ . _ . _ _ . - - - - - - - _ _ - - - - - - - - . - - - - - - - - - - - - - - - - - - -- -~- ---
l l 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 - 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 a 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 mater ials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment. 13 Enclosure l l
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10 CFR Part = Byproduct material, Criminal penalties, Labeling, Nuclear materials, ; Radiation protection, Reporting and recordkeeping requirements, and Sciencihc equipment. 2 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 W Y amendments to 10 CFR Parts 31 and 3 W PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL e
- 1. The authority citation for Part 31 is revised to read as follows:
6 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). For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273); 5S31.5 (c)(1)-(3) and.(5)-(9)', 31.6, 31.8(c), 31.10(b),-and 31.ll(b), (c), and : (d) are issued-under sec. 161b, 68 Stat. 948, as amended-(42 U.S.C. 2201(b); and ss31.5 (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)).
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- 2. Section 31.2 is revised to read as follows 31.2 Terms and ditions.
'T 14- Enclosure
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,= The general licenses provided in this, pcrt 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 8 general license. "- f I 3. In S 31.4 paragraph (b) is revised to read as follows: 5 31.4 Th[bAaiionc5ectioErequirements: OMB appr D t e e s s
- s (b) The approved information cellection requirements contained in this part appear in SS 31.5, 31.6, 31.8, and 31.11.
g ,+ + + M'
- 4. In 5 31.5, paragraph (b) is revised and paragraph (c)(ll) is added to ead as, follows 31.5 Certain measuring, gauging, or controlling devices.* V
^ * *
, (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
(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 1icensersnall 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. 4 (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 S 31.5(c)(1) through 0) have been met. - g -){- k $
- 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 generally licensed in S 31.5. Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, distribute, install, or service devices q 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 ir, offs;n,.e waters, as defined in S 150.3(f), provided that: (a) The Agreement State licensee files the appropriate transfer reports as required by paragraphs (a) and (b) of S 32.52, s s s e s
*- l C
M (d) The person shall furnish a copy of the general license contained 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. 4 (c) 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 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 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. 1 1 17 Enclosure
1 PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
- 6. The authoriti cit t'on 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.$ 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 e are issued under sec. 161o, 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:
5 32.51a Same: Conditions of licenses. (c) Furnish the individuals identified under S 31.5(c)(ll) or S31.6(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:
5 32.52 Same: Material transfer reports and records. : 18 Enclosure
I Each person licensed under S 32.51 or S 31.6 to initially transfer - devices to generally licensed persons sh:.ll: (a) Report quarterly to the Director of the Office of Nuclear Material Safety and E:fcge:rds, 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 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 ar k
.,323 S 32.310. " Transfer Report Format," or on a clear and legible record as
^,h 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 4
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 l 19 Enclosure !
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.
(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 Ej ion 32.31 added to 10 CFR Part 32 to read as follows:
4 Subpart E - Report of Transfer of Byproduct Haterials S 32.310 Transfer Report Format. l o s section contains the format required by S 32.52. l 20 Enclosure
Subpart E-Report of Transfer of Byproduct Materials Section 32.310 - Transfer Report Format NAME OF VENDOR AND LIC$NSE NUMBER REPORTING PERIOD FHOM TO GENERAL LICENSEE INFORMATION COMPANY NAME, 6TREET, CITY, DEPARTMENT STATE, ZIP CODE SERSON 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 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 Comission. 4 pames M.7 )aylor. f.
,9forOperations.(xecutiveDirector 5
a 22 Enclosure
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8' ' ?'n UNITED STATES E, c s i NUCLEAR REGULATORY COMMISSION-
* / WASHINGTON, D.C. 20666 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 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 t1e NRC with specific information about the licensed c;evices. Corresponding changes would also be made in 10 CFR Part 32 on tiin transfer reporting requirements imposed on persons authorized to distribute byproduct material. These changes are being made because there is inadequate accounting for generally licensed devices, and also a general lack of awareness of the appropriate regulations on the part of general licensees.
.It is anticipated that the proposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC.
Sincerely,
, h A.
Eric S. Beckjord, Di ector Office of Nuclear R ulatory Research
Enclosure:
Notice of Proposed Rulemaking cc: The Honorable John J. Rhodes /-
0 it fhD 34-l ) d 'o,, UNITED STATES hDk l 8 a NUCLEAR REGULATORY COMMISSION W ASHING TON. D. C, 2055$
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! FROM: DUE: 10/18/91 EDO CONTROL: 0007077 DOC DT: 10/04/91 FINAL REPLY: COMMISSIONER CURTISS TO: . . . JAMES M. TAYLOR FOR SIGNATURE OF: ** PRI ** CRC NO: EXECUTIVE DIRECTOR DESC: ROUTING: Q'S RE SECY-275, PROPOSED AMENDMENTS TO 10 CFR , TAYLOR PARTS 31 AND 32 SNIEZEK THOMPSON DATE: 10/07/91 BLAHA ,e
, BERNERO (
ASSIGNED TO: CONTACT: - ,
< LIEBERMAN g RES BECKJORD ,. ,
5 4 , +- SPECIAL INSTRUCTIORS OR REMARKS: 7
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October 4,.1991- -i OFFICE OF THE . ,
' COMMissachtR MEMORANDUM-FOR: James M. Taylor- --
Executive-Director for Operations y FROM James R. Curtiss . 61 . t i
SUBJECT:
PROPOSED AMENDM S TO 10 CFR PART 31,
" GENERAL DOMESTIC LICENSES FOR BYPRODUCT-MATERIAL," AND 10 CFR PART 32, " SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR' TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL"
.(SECY-91-275) -,
Before I vote on the subject paper, I would appreciate answers to the followinr' questions:
- 1) How'do the proposed changes relate to the provisions of 10 CFR Bart 1507 .For example,-is the imposition.of a L
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 150?
- 2) The paper indicatas 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?
- 3) 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?-
f0 ' Q 'Il ~ EDO --- 007077 Ii'7'd 1 di n] t'. - *J%,.:
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- 4) Is the computerized data base limited to NRC licensees?
Did the staff consider a national computerized data base for all general licensees?
- 5) 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?
- 6) 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? ,
- 7) -Has the staff considered the results of the survey reported to the Commission in SECY-91-241 in formulating the recommendations contained in SECY 275, particularly the situation that existed with tritium light sources (i.e., th. apparent lack of control over sources sold primar.*1y in 1989)? What, specifically, does the staff recoamend to ensure that this situation is avoided in the future?
4
- 8) 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?
- 9) In view of the instances of poor reporting by NRC-licensed distributors, are additional inspection and enforcement efforts needed to ensure m7re comprehensive identification of-recipients by distributors, in order to implement the notification provisionc of this rule?
- 10) 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?
- 11) The discussion of costs in section 4.2 of Enclosure 3 does not include the c~ost associated with implementation of the rule by Agreement States. In view of the fact that this rule will become a matter of
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- compatibility, would it:be' appropriate to include-a
. discussion or such costs? :
cc t - The-Chairman: Commissioner Rogers' e Commissioner Remick SECY - _ - -- . . GPA 1 5 e f A if - t 4 I f. 4 i 1 9 4
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b 3 4-- l NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION fDg TO BRENDA J0. SHELTON (T714-MNBB) ACTION DATE NRC CLEARANCE OFFICER U.S. NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 Nuclear Regulatory Commission 10/08/91 ON 08/13/91. YOU REQUESTF0 APPROVAL OF THE FOLLOWING INFORMATIOR COLLECTION: TITLE 10 CFR 31, GENFRAL ODMESTIC LICENSES FOR BYDRODUCT *tATERIAL AGENCY FORM NOS.* (N ACCORDANCE WITH THE PAPERWORK REDUCTION ACT, WE HAVE TAKEN THE FOLL3 WING ACTION ON THIS INFORMATIDN COLLECTION: APPROVED FOR USE THROUGH 05/31/93. 3MB NO. 3150-0016. THE OFFICE OF MANAGEMENT AND BUDGET CONTROL NUMBER MUST BE DISPLAYED IN ACCORDANCE WITH 5 CFR41320. UNLESS OTHERWISE PROVIDED IN " REMARKS," EXPIRATION DATES MUST ALSD DE DISPLAYED AS REQUIRED BY 5 CFR 1320. EFFECT ON' BURDEN: RESPONSES REPORTING HOURS PREVIOUS STATUS 653 799 NEW STATUS 653 T99 O!FFERENCE
- O O TEMARKS:
4 i
$ . _ . . t. ,
NOTICE OF 3FFICE OF MANAGEMENT AND BUDGET ACTION PAGE 2 OMB NO2 3150-0016 AUSTRACT
'R A0!0 ACTIVE MATERI ALS, R ADI ATION S AFETY'
-THE PROPOSED RULE, 10 CFR 31 AND 32, REQUIREMENTS FOR THE - POSSESSION OF INDUSTRIAL DEVICES CONTAINING SYPRODUCT MATERIAL, REQUIRES LICENSEES TO RESPOND. TO NRC ABOUT R ADIDACTIVE MATERI AL USED UNDER THE GENERAL LICENSE PROVISION OF 10 C.FR .)l.5 AN3 REQUIRES DISTRIBUTORS OF DEVICES AUTHORIZE 0 UNDER 10 CFR 31 5 AND 32.52 TO USE A UNIFORM _ FORMAT FOR QUARTERLY REPORTS. ALLOWANCE. LETTER NO FUNCTION: DN PLAN NO EXCEED BJ0GET: NO 3504(i): N/A N0e OF FORMS: I USE: PUBLI; REQUEST: REVISION RESPONDENTS: 69,000 RESPONSES -653 HOURS: 799 AFFECTED ~ PUBLIC: ST ATE /LCL GOV E BUS / INST C NON-PROFIT INST SMALL BUSINESS YES ACTIVITY TYPE:
- PURPOSE: REG / COMP
' FREQUENCY: OCCAS COLLECTION METHOD: MAIL S/A , RETENTION: COLLECTION AGENT: RC0KPNG RQT CONFIDENTIALITY: YES 1 COMPULSORY STATUS: MANDATORY . FEDERAL COST: PUBLIC COST: REVIEWER: Ron Minsk . .CCTION_ _ .! AUTHORIZING OFFICIAL ! TITLE: DEPUTY ADMINISTRATOR!DATE 110/08/91 AFPROVED BY2 t/S/ JAMES B. MACRAE FOR ! OFFICE OF INFORMATION
!- !AND REGULATORY AFFAIRS ! 'IMPORTANT: BECAUSE THIS INFORMATION COLLECTION HAS BEEN APPROVE 0, PLEASE SEND
- TO THE 0.M.B.:AS SOON AS AVAILABLE: ONE COPY OF THE FINAL PRINTED (OR OTHERWISE REPRODUCEO) REPORT FORM, OR REPORTING OR RECOR0 KEEPING REQUIREMENT, TRANSMITTAL
- LETTER, INSTRUCTIONS, AND ANY_ DOCUMENT BEING SENT TO EACH RESPONDENT. ,
J =1 ... NOTICE OF'3FFICE:0F. MANAGEMENT AND BUDGET ACTION ,, , TO s. BRENDA J0. SHELION (T714-MNBB) ACTION DATE 1 NRC CLEARANCF OFFICER U.S. NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 Nuclear Regulatory Comelssion 10/08/91 CN 08/13/91, YOU REQUESTED APPROVAL OF THE FOLLOWING INFORMATION COLLECTION $1TLEt 10L CFR P ART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTUR'E ORLTRANSFER CERTAIN ITEMS CONTAINING SYPRODUCT MATERIAL QGENCY' FORM NOS.: BN ACCORDANCE WITH . THE P APERWORK REuuCTION ACT, WE HAVE TAKEN THE FOLLOWING DCTION CP4 THIS INFORMATION COLLECTION GFPROVED FOR USE THROUGH 05/31/93. OMB NO. 3150-0001. hHEOFFICE-0FMANAGEMENTANDBUDGETCONTROLNUMBERMUSTBEDISPLAYEDIN QCCORDANCE _ WITH 5 CFRi1320. UNLESS OTHERWISE PROVIDED IN " REMARKS ," 3XP! RATION DATES MUST ALSO SE DISPLAYED AS REQUIRED BY 5 CFR 1320. s QFFECT ON~ BURDEN: RESPONSES ~ REPORTING HOURS B REVIOUS STATUS. 11,825 11,480 .EW STATUS 1 1 ,.8 2 5 11,480 rIFFERENCE O O 2EMARKS: 4
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'5 L NOTICE CF JFFICE OF MANAGEMENT AND BUDGET ACTION PAGE 2 I
OMS NO. 3150_0001-ABSTRACT: , OR AOIDACTIVE H ATERI ALS, R ADI ATION S AFETY' THE PROPOSED RULE, 10 CFR 31 AND 32, REQUIREMENTS FOR THE POSSESSION
]F INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL, REQUIRES LICENSEES TO ' RESPONO TO NRC ABOUT R A010 ACTIVE MATERI AL USED UNDER THE GENERAL
_ICENSE PROVISION OF 10 CFR 31.5 AN3 REQUIRES DISTRIBUTORS OF DEVICES AUTHnp T1fD UNDER 10 CFR 31.5 AND 32.52 TO USE A UNIFORM FORMAT FOR 3UARTERLY REPORTS. ALLOWANCE LET1ER: NO FUNCTION: DN PLAN: N0 EXCEED BUDGET: NO 3504(H): N/A
- 10. OF FORMSJ 1 USE: PUBLIC REQUEST: REVISION lESPONDENTS: 306 RESPONSES: 11,825 HOURS: 11,480 l\FFECTED PUB 1.IC: STATE /LCL GOV C BUS / INST C NON-PROFIT INST
-iM ALL BUSINE SS: YES ACTIVITY T YPE: 'URPOSE: REG / COMP
- REQUENCY: OCCAS C OTLY C ANNL C 3THER
- 0LLECTION METHOD: MAIL S/A RE TE NT I ON: COLLECTION AGENT: RC0KPNG RQT CONFIDENTIALITY: NO OMPULSORY STATUS: MANDATORY CEDERAL COST: PUBLIC COST:
REVIEWER: Ron Minsk 4 , i 1CTION ! AUTHORIZING OFFICIAL ITI1LE: DEPUTY ADMINISTRATOR!OATE
,PPROVED BY: t/S/ JAMES B. MACRAE FOR ! OFFICE OF INFORMATION 110/08/91
! !AND REGULATORY AFFAIRS !
MPORTANT: DECAUSE THIS INFORMATION COLLECTION HAS BEEN APPROVE 0, PLEASE SENO O THE 0.M.B. AS SOON AS AVAILADLE: ONE COPY OF THE FINAL PRINTED (OR DTHERWISE , EPRODUCEO) REPORT FORM, OR REPORTING OR RECOR0 KEEPING REQUIREMENT, TRANSMITTAL ETTER, INSTRUCTIONS, AND ANY 00CUMENT BEING SENT TO EACH RESPONDENT. { l _ _ --" ~ ^- '- '}}