ML20217L058
| ML20217L058 | |
| Person / Time | |
|---|---|
| Issue date: | 05/21/1999 |
| From: | Veronica Wilson NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20217K959 | List: |
| References | |
| FRN-63FR42269, RULE-PR-31 AG06-2-011, NUDOCS 9910270056 | |
| Download: ML20217L058 (30) | |
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. UNITED STATES a
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O NUCLEAR REGULATORY COMMISSION iE WASHINGTON. D.C. 20555. @ 01 '
\...../ May 21, 1999 Toe MEMORANDUM TO: Donald A. C' ool, Director tb 0 '
1 Division of Industrial and Medical Nuclear Safety
- Office of Nuclear Material Safety and Safeguards 1
FROM: Valeria H. Wilson, Director k}-%g j Division of Administrative Services /
Office of Administration
SUBJECT:
OFFICE CONCURRENCE ON THE PROPOSED RULE ENTITLED l
" REQUIREMENT FOR THOSE WHO POSSESS CERTAIN l INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO -
PROVIDE REQUESTED INFORMATION"
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The Office of Administration (ADM) concurs on the final rule that requires general licensees who possess certain generally licensed industrial devices containing byproduct material to provide requested information. We have attached a marked copy of the prop,osed rule l package rule that presents our comments. i We have included language necessary to indicate compliance with the National Technology Transfer and Advancement Act of 1995 as specified in the interim guidance issued on May 3, 1 1999. j If you have any questions concerning this matter, please have a member of your staff contact David L. Meyer, Chief, Rules and Directives Branch, at 415-7162 (DLM1) or Michael T. Lesar, ADM, at 415-7163 (MTL).
Attachment:
As stated l
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9910270056 991022 PDR PR 31 63FR42269 PDR f?/82?c2h5g
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a kS' UNITED STATES NUCLEAR REGULATORY COMMISSION f- WASHINGTON, D.C. 20555-4001 d$,
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- MEMORANDUM TO
- William D. Travers Executive Director for Operations
! FROM: Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
FINAL RULE: 10 CFR PART 31 " REQUIREMENT FOR THOSE
.WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE i REQUESTED INFORMATION" Attached for yot,r signature is a final rule (Attachment.1) containing amendments to 10 CFR Part 31 that wWexplicitly require generallicensees who possess certain devices containing byproduct material to provide the U.S. Nuclear Regulatory Commission (NRC) with information concerning devices that they have received for use under a generallicense. This provision will ,
- be used primarily to institute a registration and accounting system for devices using certain '
quantities of specific radionuclides.
Backoround: A proposed rule was forwarded to the Commission on August 19,1994in ->
SECY-98-199. It was approved by the Commission in an SRM dated October 23,1998
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- (Attachment 2), and published for public comment on Decemler 2,1998 (63 FR 66492). Seven comment letters were received. - Many of the comments recommended further action by the __
Commissiortph5 Mddressed in the second, more comprehensive rule 4SECY-99-108). No ]
. change r a
Eeen w mad ~x 7)y ,s-cum,w h/~-m s vac
. ) ~, i in the October 23,1998, SRM the Commission also directed'the staff to follow up on W'! I information obtained by mailing copies of the proposed rule to generallicensees. A brief * ' '[. [ p summary of that effort is provided in Attachment 3. /'W The Regula+ory Analysis for this rule is provided in Attachment 4.
Notices: . The jppropriate Congressional committees will be notified (Attachments 5 and 6). A press release will be issued (Attachment 7). An item for the Daily Staff Notes appears as Attachment 8.
CONTACTS: Catherine R. Mattsen, NMSS/IMNS (301) 415-6264 Jayne M. McCausland, NMSSnMNS (301) 415-6219
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Resources: Jhb resources needed t implement this actio are~in the cur nt budget.
l AdSc,r,a"y the, registration program _ud;;J ic established for FY 1999 and 2000. The total resources needed to develop the registration and followup program for generally licensed sources / devices were estimated in accordance with the Commission's April 13,1998, SRM and were provided in SECY-99-108.
7)m ,,</b. i: rw.edll D l Schedule: The staff s ' waiting' for Commission direction on the proposed comprehensive generallicense rule efore the Commission ff(
been diafted assuming that theedsecond propos[SECY-99-108, April 9,199 rule would e published before this final rulg, . , .
' Therefore, the staff will forward this rule for publication after the second proposed rule 7g / +/ , ,.
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Coordination: The Offices of Administration, Enforcement, and State Programs concur with + .F# l these final amendments. The. Office of the General Counsel has no legal objection to this fina g/
fu- f rule. The Office of the Chief Financial Officer has reviewed the final rule for resource impacts ,, 7f -
' and has no objection. ' The Office of the Chief Information Officer has reviewed the final rule fo information technology and information m'anagement implications and concurs in it. '/
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Attachments:
- 1. Final Federal Register Notice with diskette q' l2. .SRM dated October 23,1998
- 3. Proposed Rule Mailings Followup j
- 4. Final Regulatory Analysis
- 5. CongressionalLetters 1
' 6. Notification for Congressional Review "Small Business
- Regulatory Enforcement Fairness Act of 1996" j
- 7. Draft Press Release
- 8. Daily Staff Notes Item
- 9. Approved for. Publication i
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(f W. Travers 2-Resources: The resources needed to implement this action are in the current budget.
Additionally the registration program budget is established for FY 1G9 and 2000. The total resources needed to develop the registration and followup progran, for generally licensed 1 sources / devices were estimated in accordance with the Commission's April 13,1998, SRM and were provided in SECY 99-108.
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Schedule: The staff is waiting for Commission direction on the proposed comprehensive j general license rule before the Commission in SECY-99-108 (April 9,1999). Both rules have j been drafted assuming that the second proposed rule would be published before this final rule.
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Therefore, the staff will forward this rule for publication after the second proposed rule. l
. 1 Coordination: The Offices of Administration, Enforcement, and State Programs concur with these final amendments.' The Office of the General Counsel has no legal objection to this final rule. The Office of the Chief Financial Officer has reviewed the final rule for resource impacts and has no objection. The Office of the Chief Information Officer has reviewed the final rule for information technology and information management implications and concurs in it.
I Attachments: '
- 1. Final Federal Register Notice with diskette
- 2. SRM dated October 23,1998
- 3. Proposed Rule Mailings Followup
- 4. Final Regulatory Analysis
- 5. Congressional Letters -
- 6. Notification for Congressional Review ".Small Business Regulatory Enforcement Fairness Act of 1996"
- 7. Draft Press Release
- 8. Daily Staff Notes item
- 9. Approved for Publication Distribution: WITS # 199800070/NMSS No.199900199 RGordon/RF PHolahan IMNS/ Central File NMSS R/F NMSS Dir. OFF R/F CPoland DMendiola . CGallagher LRiani -
NRC Central File FMiraglia EDO R/F MBridgers i
To receive a copy of this document, indicate in the box: "C* = Copy without attachrnent/ enclosure "E' = Copy with attachment / enclosure 'N' = No copy
- see pewious concurrences DOCUMENT NAME: 0:\martsen\Gl1hGitfedo OFFICE RGB/IMNS l RGB/IMNS l MSB/IMNS l D/IMNS l Tech Ed l NAME CMattsen PHolahan LCarnper DCool EKraus DATE / /99 / /99 / /99 / /99 / /99 OFFICE OSP ADM l OClO l CFO l OE l NAME PLohaus DMerr BJShelton JFunches JLieberrnan DATE / /99 / /99 / /99 / /99 / /99 i
OFFICE OGC D/NMSS DEDR- l EDO l l j NAME JGray CJPaperiello FJMiraglia WTravers
! DATE / /99 / /99 / /99 / /99
!~ OFFICIAL RECORD COPY
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Federal Register Notice l
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[7590-01-P]
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, NUCLEAR REGULATORY COMMISSION .
10 CFR Part 31 RIN 3150 - AG06 Requirements for Those Who Possess Certain Industrial j Devices Containing Byproduct Material to Provide Requested information !
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AGENCY: Nuclear Regulatory Commission. l ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations to add an explicit requirement that general licensees, who possess certain measuring, gauging, or controlling devices that contain byproduct material, provide the NRC with information )
concerning these devices.- The NRC intends to use this provision to request information concerning devices that present a comparatively higher risk of exposure to the public or property damage. The final rule is intended to help ensure that devices containing byproduct material are' maintained and transferred properly and are not inadvertently discarded.
EFFECTIVE DATE: (60 days from date of publication in the Federal Register).
, FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001,
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telephone (301) 415-6264, or e mail at CRM@nrc. gov; or Jayne McCausland, Office of Nuclear Material Safety and Safeguards,]U.S. Nuclear Regulatory Commission, Washington, DC
'20555 0001, telephone (301) 415-6219, or e-mail at JMM2@nrc. gov.
. SUPPLEMENTARY INFORMATION:
Background
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On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a general license for the use of byproduct material contained in certain
- measuring, gauging, or controlling devices (10 CFR 30.21(c)). Under current regulations in 10 CFR 31.5, certain persons may receive and use a device containing byproduct material j
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under this generallicense if the device has been manufactured and distributed according to the q specifications contained in a specific license issued by the NRC or by an Agreement State. A
. specific license authorizing' distribution of generally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for safe operation of that device are adequate and meet regulatory requirements.
The person or firm who receives such a device is a generallicensee. The general licensee is subject to requirements for maintaining labels, following instructions for use, storing
.or disposing of the device properly, and reporting transfers and failure of or damage to the device.' For some devices,' the general licensee must also comply with leak testing requirementsJ The general licensee is also subject to the terms and conditions in 10 bFR 31.2 concerning generallicense requirements, transfer of byproduct materit !, reporting and recordkeeping, and inspection. The generallicensee must comply with the safety instructions 2
contained in or referenced on the label of the device and must have the testing or servicing of the device performed by an individual who is authorized to manufacture, install, or service these 3 devices.
A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shicided 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 is meant to simplify the licensing process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary.
y,, Ii,x y There are about 45,000 generallicensees under 10 CFR 31.gwhhosse s about 600,000 devices that contain byproduct material. The NRC has not contacte.d general licensees on a regular basis because of the relatively small radiation exposure risk posed by these devices and the very large number of generallicensees. However, are thesbcense
,y -p- av u,jili o de rca i i c M ' ' //w r not always aware of appLb'e regulationsfand thus are not necessarily complying with all of
- fp Nr i met the applicable requirements. & particula { concern aEccurrences where generally lice
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devices containing radioactive material have not been properly handled or properly disposed of.
In some cases, this has resulted in radiation exposure to the public and contaminsiion of property. Although known exposures generally have not exceeded the public dose limit, there is a potential for significant exposures. Atso en a source is accidentally melted in a steel 1
mill, considerable contamination of the mill, the steel product, and the wastes from the process, j the slag and the baghouse dust, can result.
The NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to assess the effectiveness of the generallicense program. The sampling revealed several areas of concern regarding the use of generally licensed devices. The NRC concluded that many generallicensees are not aware of the appropriate regulations. proximately 15 percent l 3 l
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. of all generallicensees sampled could not account for all of their generally licensed devices.
The NRC concluded that these problems could be remedied by more frequent and timely contact between the generallicensee and the NRC.
On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking concerning the accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement for general licensees under
- 10 CFR 31.5 to provide information to the NRC upon request, through which a device registry j could be developed. The proposed rule also included requirements in 10 CFR 32.51a and l 32.52 for the specific licensees who manufacture or initially transfer generally licensed devices. I Although the public comments received were reyiewed and a final rule developed, a final rule l fpvJo was not issued because the resourcesko implement the proposed rule properly were not available.
The NRC continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. In July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group tu eva' ate these issues, A final report was completed in July 1996 and published in October 1996 as NUREG-1551," Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."
In considering the recommendations of the working group, the NRC decided, among other things, to again initiate rulemaking to establish an annual registration program of devices generally licensed under 10 CFR 31.5 that would be similar to the program originally proposed in the December 27,1991, proposed rule. However, the NRC decided to do so only for those devices that present a higher risk (compared to other generally licensed devices of potential exposure to the public and property loss if control of the device were lost. The NRC found the l
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t working group process valuabie in identifying criteria for categorizing devices that are more i
. likely to present a significant risk by exposure of the public or through contamination of j property.
On December 2,1998 (63 FR 66492), the Commission again proposed the addition of an. explicit requirement to provide information in response to requests made by the NRC. While l
l- the rule applies to all 10 CFR 31.5 generallicensees, the NRC plans to contact only those general licensees identified by the working group for the purpose of the registration program.
For the most 'part, general licensees using devices meeting these criteria have a limited number
- of devices that will require registration. . . '.
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In that ae he NRC also withdrew the December 27,1991. proposed rule. The NRC
. has reviewed the other provisions contained in the December 27,1991, proposed rule and the ,
recommendations of the working group and developed additional requirementsJn a repcrck - f v' / ( , -
pubiu/ml O ,i- l proposed rule (Insert date and FR cite). The recommendations madejp NUREG-1551 were ,a " l ppen considered in developing the second proposed rule. Thatbl addresses fees for registration, additional reporting, recordkeeping, and labeling requirements for 10 CFR 32.51 licensees, and compatibility of Agreement State regulations in this area.
On March 9,1999 (64 FR 11508), the Commission established an interim enforcement policy for violations of 10 CFR 31.5 that are discovered and reported by licensees during the initial cycle of the registration program. The initial cycle is considered to be the issuance of one round of registration requests to all affected generallicensees. This policy supplements the normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will remain in effect through one complete cycle of the registration program.
Under this interim enforcement policy, enforcement action normally will not be taken for l . violations of 10 CFR 31.5 that are identified by the general licensee, and reported to the NRC if I
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reporting is required, e general licensee kes appropriate corrective action to,,
address the specific violations and prevent recurrence of similar problemsbnd othorMc h'as undertaken r;og i faith efforts to respond to NRC notices and provide requested information.
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PThis change from the Commission's normal enforcement policy isko remove the potential for the threat of enforcement action to be a disincentive for the licensee to identify deficiencies.
Under the interim enforcement policy, enforcemengetion, inclu' ding issuance of civil
,i penalties and Orders, may be taken where there t is((kfailure to take appropriate corrective action to prevent recurrence of similar violations; tf)/$ lure to respond and provide the information required by regulation; '( ) Iful failure to provide complete and accurate i G il b i infe mation to the NRC; or (b) dher willful violations, such as willfully disposing of generally E
licensed material in an unauthorized manner.
As noted in the December 2,1998, proposed rule, and discussed further in the posed k nsert date), the Commission also plans to increase the civil penalty amounts
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specified in its Enforcement Policy in NUREG-1600, Rev.1, for violations involving lost or improperly disposed of sources or devices. This increase will better relate the civil penalty amount to the costs avoided by the failure to properly dispose of the source or device. Due to the diversity of the types of sources and devices, the Commission is considering the establishment of three levels of base civil penalty for loss or improper disposal. The higher tiers would be for sources that are relatively costly to dispose of.
Discussion The Atomic Energy Act of 1954 (AEA), as amended, authorizes the NRC to request appropriate information from its licensees concerning licensed activities. However, the 6
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Commission had not included such an explicit provision in the regulations governing 10 CFR 31.5 general licensees.
1 This final rule adds an explicit requirement to 10 CFR 31.5 that requires general licensees who possess certain measuring, gauging, and controlling devices to respond in a l l
timely way to written requests from the NRC for information concerning products that they have I received for use under a general license.
p The final rule requires a response to requests within 30 days or suchether me as /# ~
specified in the request. For routine requests for information,30 days should be adequate in most instances, and an extension can be obtained for good cause. If more complicated requests are made or circumstances recognized that may require a longer time, the Commission may provide a longer response time. In the unusual circumstance of a significant 1
- 7}y NA L f safety concern, the Commission could demand information in a shorter time. M a phone number pro the request for informatio ase additional guidance is necessary.
The NRC intends to use this provision primarily to institute an annual registration program for devices using certain quantities of specific radionuclides. The registration program is primarily intended to ensure that generallicensees are aware of and understand the reau%ments for t}e possession of devices containing byproduct material. The registration process w[ allo NRC to account for devices that have been distributed for use under the -
generallicense. The NRC believes thatyf generallicensees are aware of their responsibilities, they will comply with the requirements for proper handling and disposal of generally licensed devices. This should help reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property.
The general licensees covered by the registration program will be asked to account for the devices in their possession and to verify, as well as certify, information concerning:
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' 1. The identification of devices, such as the manufacturer, model, and serial numbers;
'2. The persons knowledgeable of the device and the applicable regulations; I 3. The disposition of the devices; and
- 4. The location of the devices.
While the final rule applies to all 10 CFR 31.5 general licensees (about 45,000), the NRC will only contact,e rfpurpoQ6f registratio 'approximately 6000 general licensees, possessing about 24,000 devices his estimate is based on the ciiteria recommended by the working group for determining which sources should have increased oversight. Requests for information will be sent to general licensees who are expected, based on current NRC records,
? /P o to possess devices containing at leastL370 MBq (10 mci) of cesium-137h.7 MBq (0.1 mci) of strontium-90 7 MBq (1 mci) of cobalt-60', o 7 MBq (1 mci) of any transuranic (at this time, the only generally licensed devices meeting this criterion contain curium-244 and Mnt americium-241).fIThrtmainrithf the devices meeting these criteria are used in com industrial applications measuring thickness, density, or chemical composition in petrochemical and steel manufacturing industries. The requests willinclude the information contained in NRC l I
records concerning the possession of these devices. The licensees will be asked to verify, I correct, and add to that information. The NRC records are based on information provided to the INRC by distributors under 10 CFR 32.52(a) and compatible Agreement State regulations and from general licensees as required by 10 CFR 31.5(c)(8) or (9) regarding transfer of generally licensed devices. If a generallicensee no longer possesses devices meeting the criteria,it will be expected to provide information about the disposition of the devices previously possessed. p ..
l Errors in current NRC records concerning these general licensees could be the result of 1) frrors made 'in the quarterly reports of manufacturers or initial distributors )henerallicensees 3 :-
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not reporting transfers,'or'(3) f,rrors made tiy NRC or its contractors in recording transfer L 5 l .'
information.
.in addition to the 6000 general licensees identified for registration, the NRC may I L
l ' occasionally request information from other general licensees on a case-by-case basis as s necessary or appropriate. For example, this~might involve investigating the extent that other users have experienced a problem that has been identified with the design of a particular device model. However, significant modifications to the registration program to include a larger class of licensees would be cione through rulemaking.
Although the amendment to the regulations imposes some additional costs on I
licensees, the NRC has estimated these costs to be minimal. This cost is the estimated ;
- administrative' cost expended by generallicensees to verify the information requested by the i
NRC regarding licensed devices. The NRC believes that the rule's intended effect of increased
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compliance by general licensees with regulatory requirements, and resulting NRC and public i
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confidence in the general license program potentially afforded by these new requirements, outweigh this nominal administrative cost.
1 Public Comments on the Proposed Rule i
The NRC reviewed the public comments received on the December 2,1998, proposed rule.. Seven comment letters were received from: the State of Illinois (an Agreement State),
National Steel Pellet Company, Steel Manufacturers Association (SMA), the Commonwealth of Massachusetts (an Agreement State), the State of New Jersey (a non-Agreement State),
American Iron and Steel Institute (AISI), and one private citizen. Il commenters supported the ,
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proposed rulg#tt) 91e commenter agreedwith the NRC that the proposed change would .
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L increase accountability and control over generally licensed radioactive devices. Another I
commenter supported the proposed regulation'as a step in the right direction, if not completely l l
solving the regulatory problems of the NRC. The steelindustry supported the proposed rule as {
a positive, although small, step toward minimizing the risk associated with improper disposal of spent sources in the scrap supply.
Agreement was expressed by two commenters that the administrative burden on general licensees to provide the minimal information requested by the NRC is reasonable, as is
. the 30-day period in which general licensees have to respond, with extensions granted for good ;
1 cause.
T; .u. . = eral commenters who voiced agreement with the interim enforcement policy. One commenter, the State of New Jersey, believes that it is extremely important to remove any incentive for a general licensee to attempt to discard its source rather than comply
- l with the reporting requirement. The commenter stated that when people get rid of their generally licensed devices in a hurry, the State has to go out and find them in mountains of trash or scrap metal.
Two other commenters, the SMA and AISI, stated that they would support any enforcement program that deters improper disposal of radioactive sources. They also endorse y i the provision allowing general licensees to report and correct violations without incurring i p 4,r ,,ic,i f & l
. penaltieheliev' that this provision would encourage licensees, who are not sure about
.e un sources they hold, to remedy the problem \rather than improperly dispose of attempt to avoid high penalties.
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Current NRC General Licensina Pro' cess and Cost Shift g Comment: In general, the three representatives of the steelindustry expressed similar concerns regarding the current NRC generallicensing process. One commenter, the SMA, stated that the proposed rule did not address the fact that the current regulatory regime has
' shifted the costs of lax accountability and control onto steel makem, insurers, and the
- taxpayers. This commenter stated that generallicensees do not pay for their licenses nor provide information directly to 'NRC about the sources they hold, instead, the cost has fallen on
' steel producers to detect the sources, on steel producers and taxpayers to arranga for proper ~
' disposal, and on steel producers and their insurers to pay the cost when a source is inadvertently melted. This commenter believed that general licensees should be required to shoulder their fair share.
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I Similarly, the AISI pointed out that current NRC regulations have inadvertently and 4
- improperly shifted the costs for accountability and control onto hot metal producers, insurers, 4 I
and taxpayerptfeel producers are being forced to pay the cost of detecting orphaned 40- > ) )
sources arrang or proper disposal, and to pay for the cleanup when a source is inadvertently melted. This commenter also believed that generallicensees should be required I to pay their fair share of these costs and stated that improving licensee accountability would also reduce the risk of the illegal release of generally licensed material into the public scrap supply. In addition, the AISI noted that the inadvertent melting of orphaned sources by domestic steel producers has'resulted in decontamination, disposal, and lost production costs 1 ranging between $10 million and $24 million at electric furnace mills and that the cost of a i similar incident occurring in a major integrated steel mill could easily exceed $100 million.
Response: The Commission recognizes the expense to the steel industry when generally licensed devices containing radioactive material are not properly disposed of or 4
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properly handled.. On6 of 'he en6drate@egfits o this rulemaking reduce the probability of lost and improperly disposed of sources, and ultimately the number of incidents of
. inadvertent meltings. This would reduce the total expense to the steel industry resulting from
'such incidents. A second, more comprehensive rule on this subject is expected to further-c
' improve accountability for devices and thus4houldelsolreduce the impact of improperly
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disposed of sources to the steelindustry. In addition,- the ufe pma registration L w,/d is& M r fee to recover the cost of the NRC enhanced oversight program for those generallicensees being required to register their devices.
- B. ~Reoortino Electronically and Data Verificationg p e !
r 1 Commenft .Two commenters recommended thatNRC provide a means for electronically 1 It ' (
reporting the information requested bybRC in order to save time, mailing expenses, and paper, the
-They also indicated that[NRC should ensure that its database has an adequate data quality
' verification system and ca,n easily flag inconsistencies. I l
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One commenter suggested that the electronic filing could be accomplished through a
[fb secure page on the NRC Internet Web Site and that(NRC could use the employer's tax identification number and a password to secure the information. This commenter also recommended that the NRC database include a data quality verification system to quickly identify and immediately notify licensees of any reporting inconsistencies and that employers couid also be required to annually verify the accuracy of the inventory.
Response: The submission of electronic applications and reports is a generic issue that 7h e impacts more than the general license ' registration program. INRC has evaluated the issue of
. permitting licensees to file applications and reports electronically and plans to publish an ;
'Jh amendment to the regulations to allow such submissions. INRC expects to publish the 12" r-i-
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$ l' amendment next year. At that time,'NRC will evaluate how this change willimpact implementation of the registration program and future enhancements to the design of the rf!IS automated system. However,1NRC currently expects that the initial registration program would require submission of hard copies of the registration forms.
1H L NRC is in the process of upgrading its information technology systems to facilitate !
processing of annual registrations. The upgrades will include adequate data verification for distributor, general licensee, and registration information and will include automated readers for i
processing the large volume of registration forms. The automated readers willidentify changes '
and inconsistencies with the database, convert changes to electronic form, and incorporate the new data.
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C. Control and Accountability ()
Comment: One commenter believed that a great deal of improvement is needed in the, f /-
, <- e regulations governing licensed radioactive devices acic thd 9ercabouts end h they are being r >
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disposed of properly aEelt that a license should not be given out to persons to own as many O
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devices as they pleasegiretendMUcense should be given out per device, thereby limiting th number of devices available and making known the number of devices in use. This commenter felt that radioactive material presents an extreme threat to health and safety even if disposed of properly.
Response: The Comrnission does not believe it is necessary, appropriate, or practical to limit the number of devices going out to generallicensees to one per licensee. Tracking the number of devices in use and who has them is achievable without such a restriction. Generally
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licensed devices are designed to be inherently safe and do not present nearly as great a risk to health and safety as the commenter suggests. Given the nature of the generallicense, i
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restrictions on numbers of devices that can be possessed would be difficult to enforce and would likely lead to difficulties in getting ccuratejnformatioqon devices possessed.
Comment: other commenter that the NR not target Mves hmmendeM businesses with specific licenses, pointing out that they are required toi(1) jave a Radiation
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7 Safety Officer, 2) Actively perform testing and inspections,' and (3) faintain written -
' documentatiorga re almos ereforep'q jw;t always
,<.;i.; aware f),s a of
/n the
//o<byproduct
- o y w riematerial
/h v regulations applicable to byproduct material managed under a general license as well and are more likely to -
adequately account for'and handle devices containing byproduct material in accordance with the regulatory requirements. r
.acummended that os he NRC target ,
general licensees that do not currently maintain byproduct material under a specific NRC i
license because these generallicensees are more likely to be unaware of the' appropriate (
regulations and are more likely tofn account for and handle devices containing byproduct materia
. Responset. Specific licensees who also have generally licensed devices are subject to r- 7h vc hr e,, ihw sp-ork /u ,y z any regulations applicable to the general license wiH be subject to registration. Given the approach of this first rule, it would be possible for NRC to simply not make this request for information from those who also hold specific licenses. However, this would require additional effort to cross reference data on specific licensees with that on generallicensees. Specific ;
licensees, while generally more aware of applicable regulations, do have problems with incomplete accountability for devices. The potential improvement in accountabiity should justify the limited administrative effort of providing registration information even in the cese of those holding specific licenses, if the additional rulemaking concerning registration is made final, specific licensees holding generally licensed devices subject to registration , may wish to avoid the additional fee.
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l If'so, they would have the option of amending their specific license, if necessary, to include the
" devices and move the devices from the general license status, in this case, labels
- may have to be changed to be consistent with the device's regulatory statusi
',j:r e d
- Comment: !! "! 0 pslNAd cut-bybe State of Illinoishhat thefey group of general es licensees in'lllinois ossessIdevices containing curium-244 in quantities that would require registration under the proposed rule.' This commenter recommended thatbNRC contact licensees poss'essing not only americium-241 but also curium-244, and noted that the j
W j& An o s , :;-. / H i,, p s,c d / / - l statement . 3 FR 68493) that americium-241 is the only transuranic radionuclide found in j generally licensed devices in quantities exceeding 37 megabecquerels (1 millicurie), is in error. j Response: The Commission agrees. The omission in th'at statement, of curium-244 as a transuranic element used in generally licensed devices meeting the criteria for registration, was an oversight. Curium-244 will be included in the registration requirement. {
l Comment: Several commenters stated that the NRC should give serious consideration I to the NRC-Agreemert 'State Working Group recommendations as contained in NUREG 1551,
" Final Report of the NRC-Agreement State Working Group to Evaluate Control and -
. Accountability of Licensed Devices." Specifically, one commenter stated that there should be a Responsible Individual (RI) and a Backup Responsible individual (BRI) for each general license.
-This commenter stated that, unlike a specific license where there are a Radiation Safety Officer and Authorizea Users, there may be only one person (RI) who has a real understanding that his
= or her company possesses a generally licensed device that contains a radioactive sourcebamt Men that RI dies, retires, resigns, or is laid oif, there may be no one at the facility withw O _
understancf appreciat' the significance of the generally licensed device. The
' commenter stated that the addition of one extra name and phone number to the records should 15
not be too burdensome on the licensee and[may help havoid the burden of responding to a N'
radiation incident involving the device.
Two other commenters recommended that the NRC consider the Working Group's S f) #
recommended comprehensive measures, including i requirementborINRC to maintain p jc p= .
inventory records,fcompare and reconci!e related discrepancies,fmandate6eporting the
- vi - ; ,, e., . < , . in ,- /.
bankruptcy of a licensee to the NRQg)and State /NRC site inspections and inventories at regular i intervals. These commenters felt that serious consideration should be given to each of these I
measures in order to prevent the continued loss of licensed sources into the scrap stream. I se th ' j One of theIa ommenters also urgedINRC to move forward with the planned I
additional regulations amending or establishing requirements for registration fees, labeling, and
)
1h ro,eme<>h sMe d 1 compatibility with Agreement State requirements 3statudthat the limited registration program would have minitral impact on the radioactive scrap problem if it is the only amendment the NRC proposes.
Response: The more comprehensive measures recommended by the NRC-Agreement State Working Group are being considered in the second, more comprehensive rule tht was /
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published on (Insert date). Comments on those issues will be addressed as part of that f/C rulemaking process.
Reaistration Proaramg c Comment: One commenter noted that the languaged4 proposal did not call for a 4g periodic registration proy.am requiring reporting least nnual ksquenop. Rather, the proposed amendment would merely restate NRC's authority to collect information from fhe licensees. The commenter pointed out thatINRC already has this authority under 42 U.S.C.
2095 and in its own regulations at 10 CFR 30.34. This commenter urged NRCK .xplici call 16 "/
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for a periodic registration program in the amended regulatiorgteti at this would remind general licensees that they have licensed radioactive sources and that there are responsibilities attached to their licenses. would indicate that the Government has knowledge of their sources and the authority to enforce prohibitions on improper disposal.
Response: The NRC has proposed e':plicit provisions for an an al registrat. ion requirement in the second, more comprehensive rule on this suojec .
(r re r M' )
lbr & c Comment: A commenter suggestedFNRC reconsLer one of the provisions a in the eI pt phinh J
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proposa5 a,t@S .' n 4"a4 (February 5,1974fthat would have required registration of the y L (J7 FA !/fEJ)p generally licensed device before customers are allowed to receive them. This commenter stated that this would ensure and document that generallicensees have received copies of the regulations and that they are aware of their rights and responsibilities.
Response: The Commission does not believe preregistration is necessary to ensure and document that generallicensees have received copies of the regulations and that they are aware of their rights and responsibilities. However, the Commission has proposed 1 amendments to address the need for the generally licensed customer to receive additional b<ru pw w ,, a h e c/ / s 7>,hp/ w h o information priOFto purchases in the second, more comprehensive rule P *' '/ /' ' -
Comment: Another commenter strongly encouragedlNRC to adopt a mandatory registration program for all sources, not merely those that pose the greatest risk to steel mills.
Response: The Commission has decided to use the criteria developed by the NRC/ Agreement State Working Group to determine which sources should be subject to the registration program. These criteria were based or c,onsiderations of relative risk and were limited to radionuclides currently in use in devices considered to present a higher risk of potential exposure, as well as potential for contamination of property.
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- b. Fee-Based Systemg f
f
, Comment . One commenter believed that a fee-based system for all generallicensees
. c tp would ensure that}NRC recovers the' minimal cost to initiate and maintain the reporting 7- th '
L program. The commenter stated that such a registration program would enable!NRC to account for c!! sources that have been distributed.' The commenter further suggested that the program could be designed to allow steel companies and the general public to trace the origins
^ of an impreperly disposed of sourcgand4hatbs would help steel companies in determining tha
- liability fo.-the multimillion-dollar clean up costskhe steel companies and their insurers incur when sources are inadvertently melted. SEwouldprovide Federal and State nuclear regulators that handle orphan sources a means to obtain reimbursemeng aodh end result .
would bn an additional deterrent against improper _ source disposition.
Another commenter tvas concerned that, even though a fee-based system for all
.W general licensees would permit [NRC to recover the anticipated cost of initiating and maintaining the reporting program, a fee schedule could slow or prevent implementation of the entire r- th
- proposal, if this is correct, the commenter recommended thatlNRC retain the proposal as published.
Response: The Commission is not addressing comments on its proposed fee-based ,.
n pubMbed <<yve, rop' ttw '
I ^s .,b system as part of this rulemaking process.- The second ruleFaddresses fees for registra _
the comments will be considered in connection with that rulemaking, f
- k. Reaistration Information Available on the Internet j.]
Comment: One commenter was opposed to making the registration information 4
'available on the Internet because such posting would unnecessarily cause public concern over 18 l
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the presence and use of low level devices. The commenter believes that this information I should be available only through the Freedom of Inf'ormation request process.
Response: Some of the information submitted in distributor quarterly reportsqnd entered into the generallicense'trackin'g system that is to be used for handling registration information would be considered proprietary. This database will be designed with security features in order to protect proprietary information. It will not be available on the internet. The NRC would post information on its website concerning lost or unaccounted for devices.
h Civil Penalty Amoun'tsQ Comment: One commenter agreed with the NRC's intent to increase the civil penalty
. amounts for violations involving lost or improperly disposed of sources or devices. The commenter stated that the penalties must be significantly higher than the costs avoided by the failure to@rpispose of the source or devic 3 A second commenter suppohed fining general licensees who violate their general licenses by using a schedule that is proportionate to the damage actually caused by the lost source. The commenter used the example of the cost for cleaning a steel mill contaminated by Jh:
melting such a source. This commenter believed that becauseFNRC's proposed penalty is n much higher than the current fine of $2500 per loss that has been assessed to licensees, it would not significantly deter illegal behavior. The commenter believes that increasing the
~ current relatively minimal penalty levels to amounts that reflect the real world damage caused by loss of a licensed source will provide general licensees with a substantive economic incentive to dispose of their sources legally.
l Besponse: As discussed in the proposed rule s date and FR cite)
-fcc ccw.pias.u;b ru!s), the Commission is considering raising civil penalties for violations 19
involving lost or improperly disposed of sources or devices and may use a tiered approach with higher.than usual civil penalties for sources that are relatively costly to dispose of. This is to
' ensure that such civil penalties better relate to the costs avoided by the failure to properly dispose of the source or device. The cost of cleaning a contaminated steel mill would not be an
, j;n ,
appropriate basis for setting fees. n '
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/ p.
No comments were made concerning the specific worriing of the! proposed a~et No change to the rule has been made as a result of these comments.
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Agreement State Compatibility 1
Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997 (62 FR 46517), this final rule is classified as Compatibility Category D. Category D means the provisions are not required for.
purposes of compatibility; however, if adopted by the State, the provisions should not create any conflicts, duplications, or gaps in the regulation of AEA material. Ultimately, an enhanced o
' versight program is expected to include provisions that will require a higher degree of (ple) fwn:.;v compatibility. This is being considered in the rule gd more explic t
. requirements for the registration png.:.m and additional provisions concerling accountability of .
general!y licensed devices.
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4 M , Environmental Impact: Categorical Exclusion l
l The NRC has determined that this final rule is the type of action described in the l categorical exclusion in 10 CFR 51.22(c)(3)(iii). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this regulatica.
Paperwork Reduction Act Statement
- This final rule amends information collection requirements that are subject to the l
' Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The information collection requirements in this rule have been approved by the Office of Management and Budget,. i
~1 approval number 3150-0016.
l
.The public reporting burden for this information collection is estimated to average l 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the I information collection.
l Public Protection Notification -
l 1
-If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
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! INSERT 21 A l Voluntary Consensus Standards
[. The National Technology Transfer and Advancement Act of 1995, Pub. L 104-113,
- requires that agencies use technical standards that are developed or adopted by voluntary consensus standard bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. - In this final rwei m'e NRC is amending its regulations to require that those who possess certain industrial devices co;;taining byproduct material to provide certain
. -requested information. The amendments are administrative in nature and require certain types I
- - 1 i of specific entities to provide information conceming specific devices in their possession.
Therefore, this action does not constitute the establishment of a standard that establishes l
1 - generally-applicable requirements.
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I Regulatory Analysis l
i The NRC has prepared a regulatory analysis for this' regulation. The analysis examines
' the cost and benefits of the alternatives considered by the NRC. The regulatory analysis is
~
available for inspection in the NRC Public Document Room,2120 L Street NW. (Lower Level), I l
. Washington, DC. Single copies of the analysis may be obtained by calling Jayne McCausland, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6219; or e-mail at JMM2@ nrc. gov.
Regulatory Flexibility Certification l As required oy the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies Jcd that this final rule wi[not have a significant economic impact on a substantial number of small o 5 entities. This rule wdrequirebgeneral licensees who have received specific devices to respond to requests for informdion from NRC. The final rule applies to the approximately 45,000 persons using products under an NRC generallicense, many of whom may be classified as ,
small entities. However, the NRC intends to request 7 , reg)istration
/ M c r/> information
% 4 h Awtwfrom4onlyj f, , , .. . . ,
approximately 6000 of these generallicensee pbout the identification of the devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the devices. The NRC believes that the economic impact of +he tcqunenientsbf sin w; v3 a es n/# cf~ .ru,gs/yii.; /p o fy,,e s t' u rr a, s '
M any generallicensee a. negligible increase in administrative burden. he final rule is v- ,-
intended to ensure that generallicensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.
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I' Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this rule, because these amendments do not involve any provisions that impose backfits as defined 'l In 10 CFR 50.109(a)(1) and, therefore, a backfit analysis is not required.
1 Small Business Regulatory Enforcement Fairness Act in accordance with the Small Business Regulatory Enforcement Fairness Act of 1996,
. the NRC has determined that this action is not a major rule and has :/erified this determination with the Office of Informatio'. and Regulatory Affairs, Office of Management and Budget.
' List of Subjects in 10 CFR Part 31 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and
. containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment.
For the reasons set out above and under the authority of the Atomic Energy Act of 1954, 552 and
. as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C.h53, the NRC is adopting the following amendments to 10 CFR Part 31, 23 j
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l PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL i i
- 1. The authority citation for Part 31 continues to read as follows:
AUTHORITY: Secs. 81,161,183, 68 Stat. 935, 948, 954, as amended (42 U.S.C.
l 2111,2201,2233); secs 201, as amended,202,88 Stat.1242, as amended, 1244 (42 U.S.C.
1 5841,5842).
Section 31.6 also issued under sec. 274,73 Stat. 688 (42 U.S.C. 2021).
I 2. Section 31.5 is amended by adding paragraph (c)(11) to read as follows:
9 31.5 Certain measuring, gauging, or controlling devices.2 )
(c)
(11) Shall respond to written requests from the Nuclear Regulatory Commission to f
provide information relating to the generallicense within 30 calendar days of the date of the request, or other time specified in the request. If the generallicensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by submitting a letter to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 and provide written justification as to why it cannot comply.
2 Persons possessing byproduct material in devices under a general license in 10 CFR 31.5 before January 15,1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of 10 CFR 31.5 in effect on January 14,1975.
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Dated at Rockville, Maryland, this day of 1999.
For the Nuclear Regulatory Commission.
1 William D. Travers, Executive Director for Operations.
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ATTACHMENT 2 l
SRM dated October 23,1998 I
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Action: Paperiello, S5 F
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4 ATgo 3 m :js: 7 eavers
.j - tu E ' UCLE AR RE G ULPO: < : :'."' 5 5
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October 23, 1998 Blaha
- Meye r, ' ADM OFFICE OF THE Shelton, CIO SECRETARY Lieberman, OE Bangart, SP MEMORANDUM TO: Mattsen, NMS$
William D. Travers McCausland, NMSS Executive Director for Operations Anthony J. Galante Chief I r tion Officer FROM: John C , c
SUBJECT:
STAFF REQUIREMENTS - SECY-98-199 - PROPOSED RULE:
10 CFR PART 31 - " REQUIREMENT FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIALS TO PROVIDE REQUESTED INFORMATION" The Commission has approved publication of the proposed rulemaking for 10 CFR Part 31.5 with the changes indicated in the attachment
_ (EGO) (NMSS). (SECY Suspense: 11/20/98) 1998000N The staff should provide the Commission with its best estimate of the schedule and milestones necessary to complete the automated registration system once the business case has been completed and reviewed by the information Technology Business Council, and the recommended alternative has been approved by the EC (if the project cost is over $500K) or the CIO (if the project cost is less than $500K).
(EGO). (NMSS) (SECY Suspense: 920/99) 199800071 1/13/99 The staff should continue to work closely with the Office of the Chief Information Officer (OClO) to ensure that the automated registration system is developed in a timely manner. In order to control the costs of the automated system, the staff should critically evaluate the program needs.
In evaluating alternatives, the staff should explore options such as commercial-off-the-shelf rtgistration software and registration software available from the States or other government egencies that would be sufficiently capable of meeting the basic information capture, recording, and response requirements of the device registration program. The OClO should ensure that resources devoted to the CPIC analysis are " scaled to the size and complexity of the proposed IT investment
- and do not impose "an undue burden on the NRC program staff" (as discussed in SECY-98-032).
Fullimplementation of the registration program should commence no later than deployment of the automated registration system. In the interim, the staff should take the following steps to cddress potential safety significant situations. Since the staff plans to forward the proposed rule to affected generallicensees for information purposes, the staff should plan to " screen" any
( 4 8[D49-OS2f
r information received as a result of this mailing. Specifically, the staff should make available resources to triage the incoming information based on its safety significance, establish simple criteria for determining when, and what type of, follow up action is commensurate with the )
I potential public health and safety risk associated with the device, and perform limited scope inspections when indicated. Follow up activities could range from a simple telephone contact to a limited scope inspection to confirm source identification, location and disposition. Disposition of the information collected in such follow up activities should also be based on its safety significance. This process does not have to be an elaborate one but is intended to identify those situations that, from a public health and safety perspective, warrant action. To complete this j approach, the staff should consider developing the interim enforcement policy prior to the final I rule-as currently planned by the staff-in the event that there is a need to " grant amnesty in a specific situation identified as a result of the initial mailing to generallicensees discussed above.
j Regardless of when the interim enforcement policy is implemented, the staff's plan should '
remain in effect through one complete cycle of the registration program. Also, the Federal Reoister should be revised accordingly.
Regarding the second more comprehensive rule -- the staff should involve the Conference of Radiation Control Program Directors and Agreement States early in the rulemaking process by sharing the draft rule language at the earliest opportunity and including Agreement State and non-Agreement State representation on the Part 31 rule-writing team. This approach will help ensure timely resolution of such key issues as additional device labeling requirements and compatibility.
Attachment:
As stated cc: Chairman Jackson Commissioner Diaz Commissioner McGaffigan OGC CFO OCA OlG OPA Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
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Editorial Changes to Attachments to SECY-98199 f
I Chances'to the Federal Reaister Nohce:
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- 1. }
. On page 1,' paragraph 1, line 2. change .'use' to ' possess.'
- 2. - !
'On page 4, first full paragraph, line 3. insert ' exposure' after ' radiation.' I
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3.
. On page 8, after. item 3, insert a new item as follows: '4. !
The location of the devices * .
{
< i Chances to the Reculatory Analysis:'
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- 1. In page 15, in item 4.2, line 1,' add an 's' to ' result.'
t 2.
On page 21, first full paragraph, lines 4 5, delete the remainder of the sentence after
' devices.
- 3. -
On page 24, last paragraph, line 3, delete the 's' on ' licensees.'
1 Chances to the Conoressional Letters:
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- in paragraph 1, line 3,' replace ' add an explicit requirement' with ' explicitly require.' In
' line 4, replace ' provide NRC with' with ' respond to NRC requests for.' In lines 5-6, delete
'as requested by NRC.' In the last line add 'that are primanly used in commercial and industrial applications' after ' radionuclides'.
2.
In' paragraph 2, add a new first sentence as follows: 'NRC has observed a number of instances in the past where generally-licensed devices have not been properly handled or disposed of.' In line 2, insert 'there by' after 'and.' {
Chances to the Press Release; i
1.
On page 1, paragraph 1, line 1, insert 'in Part 31' after ' regulations.' In line 3, delete the first 'the.' ;
- 2. On page 1,' paragraph 3, line 6, insert ' unnecessary' before ' radiation.'
- 3. 1 On'page 2, paragraph 2, line 1, insert 'certain' before ' general.' Add a new sentence to the end of the paragraph as follows 'About 6,000 generallicensees possessing about l
. 24,000 devices will come under the registration requirement.'
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ATTACHMENT 3 Proposed Rule Mailings Followup l
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Proposed Rule Mallings Followup A copy of the Federal Register notice was sent to approximately 47,000 generallicensee addresses on December 15,1998. Nearly 8900 mailings were returned as undeliverable, .
approximately 816 of these were potential registration licensees. r /f y 6s N>c n r'
- A contractor is performing initial followup activities potential registration licensees /
Regional inspectors will complete followup activities for licensees that the contractor cannot #[*
locate. k The process used by the contractor is as follows:
- 1. Sort returned mail to identify registration licensees.
- 2. Identify nonregistration licensees in the General License Da. abase (GLDB).
- 3. Follow up on returned mail for potential registration licensees to determine correct mailing address.
- 4. Attempt to locate registration licensees by calling telephone number included in the GLDB, searching phone books, Internet, chambers of commerce, and other sources.
Mail the Federal Register Notice (FRN) to correct address and close the followup action.
- 5. If a correct new address cannot be identified and the applicable device vendor is no longer in business, forward the open case to NRC for action.
- 6. After gathering a sufficient number of open cases, contact the device vendors to l
determine whether they have a better add,ress, or the general licensee returned the devices. H i m' '
- 7. Af ter contact witdhe vendor, either: (1h mail the FRN to the corrected address andId l close the case, (2) close the case if all devices have been returned to the vendor, or ($) l forward the open case to NRC Headquarters for further action.
The General License Project Manager notifies the appropriate regional office of the need for followup. Regional followup activities may include telephone interviews, site inspections and surveys, in-person interviews with current tenants and neighbors, and an evaluation of whether it is likely that the licensee will be located.
When to terminate looking for unaccounted for devices will be determined based on a combination of the following:
- 1. Activity of the source incorporated in the device relative to the cut-off activity levels for device registration.
- 2. Radiation levels around the device.
- 3. The length of time that has elapsed since the generallicensee was last contacted, either by the manufacturer or another party.
One of the first lessons learned from this process was that the addresses of generallicensees received from distributors were not always proper mailing addresses. The proposed comprehensive rule would make the requirement for the quarterly material transfer reports more specific in this regard.
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ATTACHMENT 4 Regulatory Analysis 1
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REGULATCdY ANALYSIS:
REQUIREMENTS FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE REQUESTED INFORMATION 1 STATEMENT OF THE PROBLEM
1.1 BACKGROUND
On February 12,1959 (24 FR 1089), the U.S. Atomic Energy Commission (AEC) amended its regulaticns to provide a general license to possess and use byproduct material in certain devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thicknecs, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition or for producing light or an ionized atmosphere. The devices ;
must be manufactured in accordance with the specifications contained in a specific license issued either by the Commission under 10 CFR Parts 30 and 32, or by an Agreement State.
There are approximately 45,000 " general licensees," i.e., persons possessing and using such devices under the general license (10 CFR 31.5). These generallicensees possess an estimated 600,000 devices.
A' generallicensee under the jurisdiction of the Commission is required to follow safety instructions on device labels. to test or service a device (with some exceptions), or to have the tecting'or servicing performed by the supplier or other specific licensee authorized to manufacture, install, or service the devices. Generallicensees may not abandon devices and I
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f must maintain records concerning the testing and servicing of the device. Generallicensees y
f must also report damage to or !oss of devices.-
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l The NRC is notified when specific licensees transfer devices containing byproduct l I .
l L material to general licensees through quarterly reports submitted under 10 CFR 32.b2(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 NRC and the general licensee); the type of device transferred; and the quantity and type of byproduct material contained in the device. Under compatible Agreerr ent State regulations, similar information is obtained from suppliers in Agreement States on transfers to NRC general
- licensees.- Further,10 CFR 31.5(c)(8) requires the general licensees to transfer or dispose of the generally licensed devices only to the holder of a specific license under Parts 30 and 32 or to the holder of a specific license issued by an Agreement State. Section 31.5(c)(9) provides a limited exception to this requirement that allows general licensees to transfer the devices to l other generallicensees, but only if the device remains in use at a particular location or the device is held in storage in the original shipping container before initial use. In either case, transfers of devices by general licensees must be reported to the NRC within 30 days of the transfer. Mc :g M d[transferTis; required if a generally licensed device is transferred t
-not' specific licensee in order to obtain a replacement device. The specific licensee making the transfer is required as part of its specific licens to maintain records of the transfer and to be accountable for all radioactive material in its possession.
1.2 NRC Study of Conformity with General License Conditions The NRC traditionally has had little contact with general licensees. The NRC staff
.. believes that this is why many generallicensees are not aware of their responsibilities under a i-l f.~
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generallicense and that this results in incidents of mishandling andamproper disposition of generally licensed devices. This, in turn, has resulted in radiation exposure to the public and, in some cases, has entailed expensive investigation, cleanup, and disposal activities. In most instances, exposures to the public have not been significant. However, these exposures would not have occurred if the devices were properly handled and disposed of.
The Commission conducted a study from 1984 through 1986 (General License Study) to ascertain the extent of compliance with generallicense conditions after it became aware of a few incidents where control over generally licensed dev;ces was lost. The results of the study were discussed in SECY-87-167, dated July 9,1987, and in SECY-89-289, dated September 14,1989. Although current regulations (10 CFR 30.52) allow for the inspection of licensees poss0ssing byproduct material, the Commission has not inspected general licensees on a regular basis. This is primarily because of the large number of these licensees and the low risk presented by most of these devices. The Commission's knowledge of whether the e
general licensees are complying with the regulations for the proper use and disposal of g ,/ ~#
generally licensed devices is limited. -
@ ,/ a j Because of the broad range of devices covered under 10 CFR 31.5, the udy was divided into two parts. The first part covered industrial gauging and measuring devices, such as large-scale level, density, and thickness monitors. There were then approximately 10,000 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 ,
i spectrometers or liquid scintillation spectrometers, and smaller-scale thickness, density, and 1
level gauges. The summary of the results of the study presented below is based on an j i
unpublished NRC report entitled " General License Study Report."
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F 1.2.1 Part i Results i The Part I study included 228 site surveys of general licensees by the study task force and 132 inspections conducted by NRC regional offices, Some Agreement States also contributed data to the " General License Study." The information gathered by the study, although from a small sample of generallicensees possessing large-scale gauges, clearly established that there is a compliance problem. Among the findings of Part I were the following:
Approximately 16 percent of these generallicensees could not account for all of i
their gauges.
A majority of these generallicensees either did not notify the NRC of transfers of d
their gauges or improperly transferred their gauges. g ///
=
- At least 25 percent of these generallicensees 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 landfills and, in one case, even in an abandoned paper mill.
1.2.2 - . Part 11 Results Although Part ll of the study covered devices that vary greatly in design and use, the range of problems encountered in Part 11 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 covered by a general license, contain tritium gas that excites phosphorous-coated glass tubes to give off light. They are used in places where wiring of electrical signs would be difficult or expensive to do. Beta backscatter gauges contain a small sealed source and a radiation 4
detector that measures how much radiation is reflected back from a material sample. The concern about these devices is the accountability of the removable source which is about 1 inch in diameter. Ninety-eight interviews were conducted of persons who possess these types of devices. The findings of Part 11 are summarized below:
Nonconformity with general license conditions was very widespread.
Only 16 percent of the generallicensees for exit signs were aware of the regulatory requirements.
Manufacturers and distributors frequently underreported the number of exit signs sold to general licensees. General _ licensees (electrical distributors and contractors) reported having about 30 percent more signs than were listed in quarterly reports of the manufacturers.
Three cases involved missing sources from beta backscstter gauges.
Only 45 percent of those surveyed for backscatter gauges were aware of the generallicense conditions.
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Vendor reports did not accurately reflect the number of radioactive sources in the possession of generallicensees. When sources were returned by general licensees to the manufacturer for disposal, the NRC was not always notified.
, -- - 7h u do c
' Mrde, NRC records were not always accurate.
1.3, Subsequent Actions
- On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking regarding the accou.. ability of generallicensees under 10 CFR 31.5. kroposed a f ht l// C number of provisions, including a requirement for these licensees to provide information at the
. request of the NRC in order to provide the regulatory basis for the registration of these devices.
5 L.
- The proposed rule also would have added requirements in 10 CFR 32.51a and 32.52 for specific licensees who manufacture or initially transfer these devices to the general licensees.
Although the public comments received were reviewed and a final rule developed, that rule was
- i. gg ,.
a wt l r.ot issued becauseIresources[to implement the proposed rule' properly were not available.
The NRC has continued to consider the issues related to the loss of control of generally i
licented, as well as specifically licensed, sources of radioactivity. in July 1995, the NRC, with assistance f.om the Organization of Agreement States, formed a working group to evaluate these issues.: The working group consisted of both NRC and Agreement State personnel and encouraged the involvement of all persons having a stake in the process and its final -
i recommendations. All working group meetings were open to the public. A final report was l
completed in July of 1996 and published in October of 1996 as NUREG-1551, " Final Repo,t of
-the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices." The recommendations of the working group prov!Je a major basis for this rulemaking.
l Some of the relevant conclusions of the working group were:
Lack of adequate oversight by regulatory authorities is a major contributing factor.to licensees losing control and accountability over their devices.
. Due to the large population of devices and the low risk associated with the design of many of the devices, an increased oversight program should only be implemented for certain devices.
. General licensees possessing the identified devices should report annually to their regulatory authority with a listing of their current inventory of devices so as to allow the regulator to independently verify that the licensee has maintained accountability and control of the devices.
~
' The NRC has also proposed a more comprehensive rulemaking to more completely address issues concerning generally licensed devices. Other recommendations of the working group were considered in that action.-
2 OBJECTIVES
_ The objectives of the amendment to Part 31 are to ensure that certain generallicensees l
' are aware of and understand the requirements for possession of generally licensed devices j containing byproduct material and to better enable the NRC to verify the location, use, and disposition of these devices. The intent is to reduce the possibility of the devices beir9 improperly transferred or inadvertently discarded. This may reduce unnecessary radiatio.i exposure to the public and unnecessary expense involved in retrieving the items, particularly in orict the scrap metal stream, as c;c" cc tbvoid the contamination of steel mills, metals, and waste
- products.
3 ALTERNATIVES
. 3.1 No action.
This alternative would be to continue the status quo. As costs and benefits are l evaluated in terms of changes from the status quo, there are no costs or benefits associated i with this alternative. df course, shoe not //m a/4niG c dress entified concerns.
M< l Often the only communica' tion between a genera icensee and the NRC is through the l I
requirement that the NRC be notified when a device containing byproduct materialis )
transferred. Information notices have been sent and inspections have been made but only rarely;.
7
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- As discussed in Section 1.2 of this analysis, general licensees have-a lack oI awareness of their responsibilities under a generallicense. The NRC staff believes that this lack of awareness is a major contributor to the occurrence of incidents of mishandling and improper disposition of generally licensed devices. ThisKhas resulted in radiation exposure to the t
public and, in some cases, entailed expensive investigation, cleanup, and disposal activities. R
.Mwhh aM/ru n s: n.
?' d ' hie, o action w ot)(appropriate.
/be !
3.2 Nonrulemaking alternatives There are a number of ways that the potential problems of lack of awareness of I regulatory requirements on the part of generallicensees could be addressed. Guidance could
'- be provided in a number of forms. However, only periodic contact with the generallicensees would be expected to have a significant impact on the level of awareness of requirements. The 10 most appropriate means to remind users of their responsibilities would befpericdi-issu=cc g ( 6 (pea 4h ret / fQ h .,
information notices / However,'these information notices may not reach all users. Whitir A/M##
-l
.--l . 10 CFR 32.52 requires that specific licensee distributors report to the NRC or the Agreement State agency the name and/or title of the individual who constitutes the point of contact betw3en the generallicensee and the NRCgor the Agreement State agency, the General t '
License Study indicated that this individual, who is frequently in the purchasing department, often did not inform the individual who uses the device of thu generallicense conditions.
aho Morec= studybndicated that personnel turnover frequently eliminated the organization's knowledge of the license conditions. For similar reasons,information notices not reach the appropriate person within the organization of a generallicensee because the contacts provided in the specific licensees' quarterly reports are frequently not the individuals 8
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responsible for, or knowledgeable of, the devices after they have been received and are being used.
l l
Even when generallicensees are aware of their basic responsibilities concerning the devices, there may be other factors contributing to noncompliance with requirements. For I
example, the cost of disposal may cause some generallicensees to dispose of devices j l
- improperly, it is important that the general licensees understand that the Commission will hold
)
l l them responsible for these aevices. Increased inspection of general licensees and
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enforcement of the requirements may improve compliance. However, without a registration
]
system, increased inspection would be on a random basis and would not be very efficient.
i None of these actions would result in a high degree of accountability for these devices.
A registration system together with followup will be more effective in terms of accountability, I
and will provide a basis for more efficient use of inspection and enforcement efforts. However, for those devices not subject a registration requirement, some increased contact such as an occasionalinformation notice may be appropriate.
! 3.3 -- Rulemaking to modify reporting requirements i l This alternative amends 10 CFR 31.5 to help ensure that devices containing byproduct l
l material are maintained and transferred properly and are not inadvertently discarded. The i
general mechanism to be used is to require general licensees to verify compliance with certain conditions imposed by the general license.
The amendment, a new paragraph (c)(11) in 10 CFR 31.5, quire general licensee to respond to requests from the NRC for verification of information relating to the bm f r ' d generallicense and the generallicensee within 30 days (or a otherwkspecified in the t
9 I
(b (of' requesQ. The licensee can request an extension within the same allotted time if he is having difficulty in providing the information.
The NRC envisions that requests will be made for verification of the information currently on record concerning devices containing byproduct material that have been transferred to the generallicensee. The general licensee will verify, correct, and add to the information, as necessary, and report on the disposition of devices no longer in the organization's possession. This process will offer greater assurance that a generallicensee is informed of its regulatory responsibilities and will provide information from an independent inventory as a mechanism to assist with verifying accountability of devices. The NRC will make periodic (expected to be annual) requests for verification to remind general licensees of their
- regulatory responsibilities and to reduce the likelihood that devices containing byproduct material are illegally transferred or inadvertently discarded.
,) cc,-
The registration conducted under this rulemaking w ot completely address the factors discussed above concerning knowledge of the regulations reaching the appropriate persons.
However, a subsequent rulemaking has been proposed which, among other things, addresses changing the suppliers' reporting requirements to provide information regarding a person with responsibility for compliance with the regulations rather than simply a point of contact.
i 4 CONSEQUENCES 1
4.1 Benefits of Chosen Alternative The revisions are intended to improve understanding of and compliance with the general license requirements nd duce the likelihood of incidents resulting in unnecessary exposures to the public and contamination of property. These revisions will better enable the 10
x as NRC to verify the location and disposition of these device.s. f thereby[confirmin efficacy of the ge'nerallicense regulatory program. The primary benefits,of this rule can be categorized
- into economic benefits and exposure aversion benefits, in this case, both of these aspects are very difficult to quantify.' Although ranges of potential exposures have been calculated and ranges of costs from individual incidents have been recorded, the working group concluded that
. none of the stu'd ies conducted are adequate to quantify an overall net cost of devices that have been improperly disposed of or lost.' An admittedly uncertain estimate was made of the current economic costs and exposures resulting from improper disposition of both specifically and generally licensed devices meeting the criteria for increased oversight. The degree of effectiveness of a particular process is also uncertain and would depend on the level of effort used in enforcement of the provision.
, . The estimate of economic costs made by the working group and adjusted here for the number of devices covered by this action is based on experience (as reported by the steel industry). g Uncertainty in these estimates comes from a number of factors including:
- The number of incidents of meltings reported is small overal[us there is considerable statistical uncertainty in how representative the costs are of future costs averted.
- a. The likelihood of loss may be diffetent for specifically and generally licensed devices and for different categories of devices. However, once a melting has occurred, i, xAly cannot be determined whether a generally or specifically licensed device was invo' 3a.
The cost of a cleanup depends on the type of steel milges.fexperIence repor
. not include incidents at large integrated steel mills and the resultant costs of such an
!' ' incident are expected to be much greater than those experienced to date, as much as l
f#N'f 19
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$100 million for a single incident.
11 1
I The likelihood of meltings depends on the level of effort on the part of metal
- manufacturers and recyclers in monitoring for radioactive sources in scrapfchh /.
generally increased over time, particularly at larger mills. />' !
t 4.1.1 Radiation Exposure Averted Benefit '
l This rule should avert radiation exposure to the public. Although it is reasonable to assume that a member of the public would not deliberately expose himself or herself or l someone else to radiation, in some cases, individuals might not understand that a gamma ,
. gauge is a potential source of radiation. When a gamma gauge is distributed to a general licensee, the gauge must bear durable, legible labels which include a caution that the gauge contains radioactive material. The generallicense in 10 CFR 31.5 requires that the general licensee' maintain those labels. However, the cautionary language can become corroded and unreadable or painted over. An individual who finds the gauge without this labeling in an uncontrolled situation would have no reason to suspect that the gauge contains radioactive i
material.
f0 If a generally licensed gauge were improperly transferred or disposed of a hat it became available to a member of the general public, no significant radiation exposure would result if the radioactive material sealed source remained in the gauge and the shutter mechanism remained closed. In addition, temporary exposure to an intact gauge should not cause a significant radiation dose The gauge would normally include a warning label with a radiation symbol and cautionary words.
- However,if a gauge with a significant source of activity were to end up in the public domain, the labeling were to be destroyed, and a person somehow exposed the source, a significant exposure could result. Radiation exposure due to improper control could conceivably i
12 i
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result in doses of a few rem to doses that are life threatening. J4o incidents in
/ .-
9 have resulted in doses in the upper rangq,)@ he likelihood of situations which could result in the highest doses is extremely small.
. Based on a June 1994 PNL report," Peer Review of Improper Transfer / Disposal Scenanos for Generally Licensed Devices," the WG estimated the average dose received from incidents of lost devices involving cesium-137 (the most common nuclide involved in incidents historically) could be 7 rem (70 mSv) and the maximum dose that might be received could be somewhat over 1000 rem (10 Sv). The PNL study considered gamma gauges containing 20 mci or greater of cesium-137.- The analysis was based on the average activity of 883 mci of cesium-137 within this category using data from the General License Data Base on devices registered in the Sealed Source Device Registry during the period 1987-1992. Gamma gauges were chosen for the example analysis as representative of relatively high risk sources amongst generally licensed devices. These were very preliminary estimates. The data has known errors and the average activity per device actually distributed is lowe a the registry information gives i rrhaimum activities to be used; also average activities used have declined.
Although the potential exists for individuals in the public to receive a very significant exposure, the probability is very low. This final rule will further reduce the probability of inadvertent exposures. .
i 4.1.2 Economic Benefits There is a cost savings to industries that neight inadvertently come into possession of an improperly disposed device. The most significant of these is the avoidance of a melting of a source and resulting contamination of a steel mill and its products and wastes.
13
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))* # ' (p a' y Based on the known incidents in he period 983 95 involving the nuclides for which
' registration is to be required, the cost of decontamination and cleanup of thcx lwJet using the average cleanup costs) is about $12 million per year. This cost can be considered as a societal cost which may be mitigated or possibly averted in the future if the rule is irnplemented.
If this rule covers 20 percent of the devices contributing to the melting experience to date (since this rule addresses only devices in NRC-regulated States and some of the melted devices may l
have been specifically licensed) and reduces the rate of incidents involving those devices by ' !
helf, the average annual cleanup costs of $12 M will be reduced by about $1.2 M per year.
There are other costs, though less significant, associated with lost sources which may I l
be reduced by this rulemaking.
The rulemaking should also reduce the number of orphaned sources. The cost of i disposalin the case of orphaned sources falls on parties other than the user of the device, such as government agencies e-g PA or DO , or individuals or organizations who inadvertently come into possession of a device.
l oA* W Them projected savings dot entirely attributable to implementation of the rule, but !
also to the planned increase in inspection and enforcement efforts. s l
4.2 Costs of Alternative I l
The amendment to 10 CFR 31.5 results in costs to general licensees and to the l
. Commission. -There also are costs to the Commission associated with the rulemaking process.
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4.2.1 Costs of Revisions to 10 CFR 31.5 to General Licensees i: . Registration process:
l The revision requires generallicensees to respond to requests from the NRC to verify information related to their generallicenses. This information can help the NRC confirm that the general licensees still possess and are in control of their generally licensed devices containing byproduct materials and are meeting the generallicense conditions imposed by the l Commission's regulations. The NRC plans to send a request for verification to each general licensee who has received a generally licensed device meeting the criteria developed by the working group and should still be in possession of it according to the Commission's records.
The cost to industry will entail a small annual administrative cost to each of I
approximately 6000 generallicensees. The GeneraLLicense Study found that the average time required to locate and verify license conditions for all devices in the possession of a general licensee was approximately 30 minutes. The general licensees included in the registration 4
requirement as planned under this rule have fewer devices per licensee on average, so we estimate an average time of 20 minutes per response. Assuming that the cost to industry for staff time is $50/hr, the annual cost of this step is estimated as:
, Cost = 1/3 hour / licensee x $50/ hour x 6000 licensees = $100,000 This estimate assumes that the generallicensees are in compliance with the requirements in 10 CFR 31.5. For some generallicensees, particularly in the first year of responding to the registration request, more effort will be involved because of their lack of awareness of existing requirements and noncompliance with some of them. The cost of this additional effort is not a direct cost of this rule.
i 15 l
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L Miscellaneous one time requests:
In addition to.the registration program, there may be an occasional need to request ;
. other information from generallicensees under this provision. For example, this might involve investigating the extent that other users have experienced a problem that has been identified with the design of a particular device model.' However, if significant modifications to the registration program, such as inclusion of a larger class of licensees, were envisioned, the Commission will not do so using this provision but would do so through rulemaking. It is estimated that no more than 100 such requests per year on average will be made. This could include any of the generallicensees under 10 CFR 31.5. As the type of information requested will vary and will not be a routine request as in the registration process, the time to respono will vary and may be longer on' average than the routine requests. in the unusual circumstance of a
- significant safety concern, the Commission could demand information in a shorter time if appropriate.
If the average time for. responding is assumed to be 30 minutes:
Cost ='100 licensees x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / licensee x $50/ hour = $2500.
Extension requests:
The rule provides that if a generallicensee cannot respond to the NRC's request within the allowed time limit, generallicensees may request an extension of time to respond. For the most part, general licensees using devices for which registration will be requested have a limited number of such devices. Thirty days will usually be provided for routine registration requests. It should be quite rare that an extension beyond the time allowed will be needed.
Also, few incidents are expected where information might be requested from other licensees.
Thus, it is estimated that only about 25 licensees will request an extension each year. The NRC estimates that the extension process will average about 30 minutes. This includes the 16
l L - time to research the subject, draft the correspondence, and any subsequent communications
- with the NRC.' The cost of this effort will be:
Cost = 25 licensees x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / licensee x $50/ hour = $625 {
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4.2.2 : Operational Costs of Revisions to 10 CFR 31.5 to NRC Registration process:
.The NRC will mail periodic (approximately annual) requests to general licensees to -
, verify compliance with certain general license requirements for all devices meeting certain criteria in the poss'ession of the general licensees. It is assumed that the NRC uses the information provided by the specific licensees that is stored in the directory and that each j I
request is computer-generated. When the NRC receives a response from a generallicensee,it j willlog kthe response into the computerized directory or record that verification has been received. It is assumed that the staff effort associated with both of these steps costs approximately $3.00 per general licensee (averaging roughly 3 minutes per request, $56/ hour).
Cost = 6000 x $3.00 = $18,000
($56/ hour is assumed because of the administrative / clerical nature of the work.)
This estimate assumes that all generallicensees comply with the requirement. The 1
number of general licensees not responding or responding inadequately is expected to be j
. greatest in the first year (about 5 percent) and decline in subsequent years. The cost of
~ followup for noncompliance is discussed below. In addition, a number of generallicensees may have difficulty accounting for the devices they have received. This number is also expected to be greatest in the first year (adding an estimated 1' 0 percent to those requiring
. followup), and fewer in subsequent years. The estimated total of 15 percent of general 17 l l
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. licensees needing followup is based in part on the General License Study and the subsequent i
L experience of some Agreement States that have initiated enhanced oversight programs.
In addition, particular y in the first year or so, there may be calls from general licensees requesting clarifications regarding the registration process as well as other aspects of their l 1
responsibilities under 10 CFR 31.5. Assuming 30 percent of all general licensees receiving a request for information call for technical assistance in the first year, and one-third of these -
require 15 minutes to respond, and the remaining average 1/2 hour of staff time, about 750 hours0.00868 days <br />0.208 hours <br />0.00124 weeks <br />2.85375e-4 months <br /> of additional staff' time may result at a cost of approximately $42,000. After the initial implementation, this is expected to be 150 hours0.00174 days <br />0.0417 hours <br />2.480159e-4 weeks <br />5.7075e-5 months <br /> (600 requests (10 percent) averaging 15 minutes) or roughly $8400.
Miscellaneous one time requests:
For the occasional requests for information from general licensees made on a case-by-case basis unoer this provision, it is estimated that NRC will make no more than 100 such requests per year on average. This is primarily expected to be requests sent to a group of licensees for a particular type of information likely relating to a particular device or device type. If this involves an average of 30 minutes per request for determining what
'information is needed, sending out the requests, and reviewing the responses, the cost will be:
Cost = 100 requests x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / request x $70/ hour = $3500.
$70/ hour is used as it involves primarily time on the part of a professional reviewer.
Extension requests:
The cost to the NRC of processing requests for extensions is estimated to average 30 minutes per request. This includes the time to evaluate the request, respond to the general licensee, if necessary, and to log in the action. The cost to the NRC for processing the estimated 25 requests is: '
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N Cost = 25 requests x 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / request x $56/hr. = $700.
Followup Costs:
- A significant cost for followup af ter the registration process is initiated is expected. The cost to NRC will come primarily from followup in cases where licensees either do not respond or cannot account for devices they have received and reconciliations of discrepancies between current NRC records and the registration information submitted by gene allicensees. Most of l this is not a direct cost of this rule, but a means of enforcing preexisting requirements. In fact.
1 the registration process allows for inspection and enforcement efforts related to the requirements in 10 CFR 31.5 to be applied more efficiently and effectively (versus inspecting these general licensees randomly). Although the Commission plans to increase inspection and i
enforcement actions as part of an overall effort to improve oversight of these generallicensees, most of the costs of this increased effort are not a direct result of this rulemaking. Most of the i
effort will be followup related to lost or improperly disposed of sources.
NRC will incur followup costs directly related to this rule when licensees do not respond to the request for information or report unaccounted for discrepancies from information in NRC records. ,
4 First Year:
in the first year, it is estimated that 6000 general licensees will be contacted and that approximately 5 percent will require followup efforts because of either nonresponse or discrepancies between the information in the NRC records and the reports of the general licensees. '
If the followup averages 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> effort at $56/ hour:
Cost = 6000 x 0.05 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr. = $33,600 19
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- Second Year:
in the second year, the NRC will request verification from the same 6000 general licensees notified the first year, as well as any new general licensees added to the database meeting the criteria for inclusion, as a result of quarterly transfer reports from the suppliers.
In'the second year, a followup rate of 2 percent is projected.
Cost = 6000 x 0.02 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr. = $13,440 Third and subsequent years:
The NRC will continue to request verification from the entire list of genera' licensees in the database. In the third and subsequent years, the need for followup is estimated at 1 percent.
Cost = 6000 x 0.01 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr. = $6,720/ year after the first two years.
4.2.3 NRC Development and Implementation' Costs NRC development costs are the costs of preparing a regulation before its promulgation and implementation. These costs may include expenditures for research in support of the i I
regulatory action, publishing rulemaking documents, responding to public comments, and-l issuing a final rule. The General License Study, the working group process, and the additional contractual work, which have been used to support this rulemaking, have already been
- performed and dealt with a broader range of issues. These costs are considered outside the scope of this analysis. Development costs within the scope of this analysis are the costs of proceeding with this specific action and consist mainly of the costs'of the effort of NRC l professional staff members expended in developing this rule. I NRC implementation costs are those " front-end" costs necessary to effectuate the j action. They may arise from the necessity of developing procedures and guidance to assist I o
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l l licensees in complying with the final action. These costs do not include the cost to the NRC of improving and maintaining a computerized directory of devices. Although the computer database must be updated in order to implement this rule, and this will be done in a way to f ~ particularly accommodate a registration process, the database must be updated if it is to provide a reasonable information base for inspection and enforcement and regulatory actions
~ ufe. . eq r wm; nycre related to 10 CFR Part 31 generallicensees/ Additional costs related to accommodating the registration process are expected to be a small fraction of the overall costs for the update and I
are not estimated here. jjic A-%
The total development and implementation costs for this rule and ssociated guidance preparatiorF estimated as: $189,000 (1 % professional staff year x $126,000).
f N
5 DECISION RATIONALE This action is being adopted because it represents a reasonable means for the Commission to fulfill its obligation to protect public health and safety, property, and the environment. It will better ensure that certain general licensees are aware of those requirements with which they must comply and provide the information on the location, use, and disposition of generally licensed devices needed to confirm the efficacy of the generallicense regulatory program and the estimates of low risk from these devices. The rationale for this recommendation follows.
The General License Study conducted by the NRC indicates that there is 6Pm[ucd noncompliance with the generallicense requirements contained in 10 CFR 31.5(c). This
- noncompliance presents a risk of low, but avoidable, exposure of the public to radiation plus a low probability of significant exposure as a consequence of improper handling or disposal of the devices generally licensed. The)BIudy revealed that a major reason for noncompliance is that 21 l
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Users of the generally licensed d'evices are unaware that there are regulatory requirements associated with the possession and use of these devices.
l l .This regulatory action will establish a reasonable procedure to ensure that general licensees are aware of the provisions associated with the general license and comply with the applicable regulatory requirements. It is believed that increased awareness and understanding of the NRC's requirements on the part of the generallicensees willincrease the likelihood that ,
general licensees will comply with those requirements and thereby reduce the potential for
. unnecessary radiation exposure to the public and prevent costs to industry from improper handling or disposal of generally licensed devices. Promulgation of this rule should result in improvement in the accountability for devices and should provide confidence that the use of i
generally licensed devices is being regulated in an appropriate manner.
This regulatory action has resulted in an estimated up-front development and I implementation cost to the Commission of $189,000 and will result in annual costs to industry and the Commission of $103,125 and $37,320 respectively, with somewhat higher costs in the first few years of implementation. Although the NRC estimates that the overall 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, there is some probability of significant dose to the public from incidents resulting from loss of devices.
The staff has concluded that the benefit of increased confidence in 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 contribution of this
-/W action to the possible avoidance of the substantial cleanup costs wiucd have occurred because of paEm oper disposition of generally licensed devices If this rule covers 20 percent of the is nepnr devices contributing to the melting experience to date and reduces the rate of incidence 22 l
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involving those devices by half, the average annual cleanup costs of $12 M will be reduced by b ~n: e of about $1.2 M per year fMhe implementation of this rule and the increased inspection and 2 enforcement efforts that are also planned.
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6 IMPLEMENTATION The regulatory action is not expected to present any significant implementation problems. The computerized directory that will be required has already been implemented by the Commission. However, it is outdated and needs improvement or replacemen[s is the case if it is to be useful to the program irrespective of this rule. General licensees will be sent a copy of the final Federal Register notice. '
E 7 ~ EFFECT ON SMALL ENTITIES As was discussed in Section 4.2.1 of this analysis, the action will have some economic impact on generallicensees of devices containing byproduct material. There are up to 45,000 generallicensees under 10 CFR 31.5 of which 6000 will be routinely requested to verify information, some of whom may be "small entities" within the meaning of the Regulatory
~ Flexibility Act (Pub. L.96-534). ' However, the economic impact on these entities will not be significant.
In Section 4.2.1 of this analysis, it was estimated that the cost of responding to the Commission's.' verification requests to general licensees will total about $100,000/yr.
It is estimated that there are approximately 24,000 devices in the possession of the Commission's generallicensees which will come under the registration requirement. The averagefcost to the generallicensee per device per year is about $4.00. Therefore, the action
- M. will not have a significant economic impact on small entities. _/'
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i ATTACHMENT 5 1
l, Congressional Letters i
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p p no uq l J ~& . UNITED STATES j .j NUCLEAR REGULATORY COMMISSION o :* WASHINGTON. D.C. 20M1
- '$ - o 9.....g The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands,
- Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate.
Washington, DC 20510 ,
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Dear Mr. Chairman:
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Enclosed for the information f the Subcommi ee is a copy of a Notice of Final Rulemaking to be published in the Federal F aister. The U. . Nuclear Regulatory Commission (NRC)is amending 10 CFR Part 31 to,explicitt@.requir that certain generallicensees who possess devices containing bypr'oduct material respond to NRC requests for information concerning devices that they have received for use under a general license. -This provision will be used primarily to institute a registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications.
NRC has observed a number of instances in the past where generally licensed devices have not been handled or disposed of properly. This amendment will allow NRC to account for devi- that have been distributed for use under the general license and thereby reduce the
. poti .at for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverso impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc:. Senator Bob Graham
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[pazuo J& UNITED STATES 7 ? E NUCLEAR REGULATORY COMMISSION I f WASHINGTON. D.C. 205$5-0001
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The Honorable Joe L. Barton, Chairman Subcommittee on Energy and Power Committee on Commerce Un.ited States House of Representatives Washington, DC 20515
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Dear Mr. Chairman:
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Enclosed for the information e Subcommi e is a copy of a Notice of Final Rulemaking to be published in the Federal F[ieoister. The U.$. Nuclear Regulat amending 10 CFR Part 31 toiexplicity require /tnat certain generallicensees who possess devices containing byproduct material respond to NRC requests for information concerning devices that they have received for use under a generallicense. This provision will be used primarily to institute a registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications.
NRC has observed a number of instances in the past where generally licensed devices have not been handled or disposed of properly. This amendment will allow NRC to account for devices that have been distributed for use under the generallicense and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers oi the public and is not expected to impose a significant burden on licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Representative Ralph M. Hall i
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l The Honorable James M. Inhofe, Chairman Subcommittee _on Clean Air, Wetlands,
. Private Property and Nuclear Safety .
1 Committee on Environment and Public Works ' '
United States Senate Washington,- DC_ '20510
Dear Mr. Chairman:
Encl'osed for the information of the Subcommittee is a copy of a Notice of Final Rulemaking to be published in the Federal Reaister. The U.S. Nuclear Regulatory Commission (NRC)is amending 10 CFR Part 31 to explicitly require that certain general licensees who possess devices containing byproduct material respond to NRC requests for information concerning devices that they have received for use under a generallicense. This provision will be used primarily to institute a registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications.
._ NRC has observed a number of instances in the past where generally licensed devices have l not been handled or disposed of properly. This amendment will allow NRC to account for devices that have been distributed for use under the generallicense and thereby reduce the
- potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Identical letter sent to: The Honorable Joe L. Barton Federal Register Notice Chairman, Subcommittee on
._ _ Energy and Power
. cc: Senator Bob Graham
- OlsTRl8uTioN; EDO 199800070 NMss 199900199 EDO r/f Mbridgers PHolahan CPoland ' CRMattsen NMss Dir. Off, r/t JMcCausland DACool -
[oSMATTsEN\GL1RGL1FCON]
To receNe e copy of tfils document, indicate 6n the bos *C* a copp Mthout attachenent/enclosu o "B* = copy w6th attachment / enclosure. "N* a No coco OFFICE RGB\lMNs l NAME CMattsen RGB\lMNs l D:IMNs l TECHED ll D:NMss [ oCA PKHolahan DCool EKraus CPaperiello DKRathbun DATE- / /99 / /99 / 199 / 199 / /99 / /99 OFFICIAL RECORD COPY
ATTACHMENT 6 Notification for Congressional Review "Small Business Regulatory Enforcement Fairness Act of 1996" t
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ss, ca > r'.-c/n 4,, - - u- z, 24722 -
Submission of Federal Rules '
Under the Congressional Review Act President of the Senate O Speaker of the House of Representatives O GAo '
Please fill the circles electronically or with black pen or #2 pencil.
- 1. Name of Department or Agency 2. Subdivision or Office U. S. Nuclear Regulatory Commission NMSS/IMNS
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3 Rule Title 10 CFR Part 31 - Final Rule to Amend 10 CFR 31.5. " Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested information"
- 4. Regulation Identifier Number (RIN) or Other Unique Identifier (if applicable)
RIN 3150-AG06
- 5. MajorRule O Non.majorRule 9
- 6. Final Rule G . Other O
- 7. With respect to this rule, did your agency so: ct public comments?
Yes S No O N/A O 8 Prienty of Regulation (fillin one)
O Economically Significant. or 9 Routine and Frequent or Significant; or Informational / Administrative /Other Substantive. Nonsignificant (Do not complete the other side of this form if filled in above )
9 Effe Cste (if appiscable) s [0 t/e p ,{bs p,}L ra % sir & Ed I/ Wihel
- 10. Concise Summary of Rule (fillin one or both) attached O stated in rule e a
Submitted by: , (signature)
Name: Dennis K. Rathbun TrJe Director. Office of Congressional Affairs For Congressional Use Only: ,
Date Received: I Committee of Junsdiction-
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3/23/99 n
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.24722 Yes No N/A L l A. With respect to this rule, did your agency prepare an analysis of costs r
' and benefits? -
G O O
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B.4 L With respect to this rule, by the final rulemakrng stage,0:d s *'ancy
' licertify that the rule Would not have a s>gnificant e< u
- 0; w 3. 9 O O, substantial number of -small entities under 5 U.S.C. 3 p
- 2. prepare a final Reg'ulatory Flexibahty Analysis under 5 U.S.C. 9 604(a)? e 0-
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l L C. ' With respect'to this rule, did Your agency prepare a wntten statement unaer , -O- G O
. $ 202 of the Unfunded Mandates Reform Act of 19957
, D. . With respect to this rule, did your agency prepare an Environmental Assessment O O O-or an Environmentallmpact Statement under the National Environmental Policy
, , Act (NEPA)?
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' Does this rule contain a collection of information requinng OMB approval e O O under the Paperwork Reduction Act of 19957 '
' ' F. Did you discuss any of the following in the preamble to the rule ? O 9 O e E.O.12612, Federahsm '
O O O e E.O.12630, Government Actions and interference with Constitut:onally O O. O j
- Protected Property Rights.- '
i e E.O.12866, Regulatory Planning and Review O O O e E.O.12875 EnhancingtheIntergovernmentalPartnership 'O O O 1
e E.O 12988. CnniJustice Reform O O O C.O.13045, Protection of Children from Environmental Health Risks O O
'ind Safety Risks O i s . Other statutes or executive ordera Jiscussed in the preamble I
- concerning the rulemaking process (please specity)
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l ATTACHMENT 7 Draft Press Release
NRC CHANGES REGULATIONS i FOR DEVICES CONTAINING RADIOACTIVE MATERIAL j
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l The Nuclear Regulatory Commission is amending its regulations in Part 31 governing the use of radioactive materialin certain measuring, gauging and controlling devices to explicitly require licensees who possess the devices to provide information to NRC upon request.
Companies and individuals are perrnitted to use the devices under an NRC " general l l
license," which means that they need not have a specific license issued to a named individual i
- or organization with specific license conditions and requirements. A generally licensed device I usually consists of radioactive material contained in a sealed source within a shielded container.
.The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. The general license is meant to simplify the licensing process so that a case-by-case determination of the adequacy of radiation training or experience of each user is not necessary.
There are about 45,000 general licensees under the Commission's general license program; they possess about 600,000 devices containing radioactive material. In the past, these generallicensees have not been contacted by the NRC on a regular basis because of the relatively small radiation risk posed by the devices and the very large number of general licensees. However, there have been a number of instances in which generally licensed devices have not been properly handled or properly disposed of, which have occasionally resulted in unnecessary radiation exposure to the public and contamination of property.
A three-year NRC sampling of generallicensees showed that approximately 15 percent of those surveyed could not account for all of their devices. The NRC believes this situation could be addressed by more frequent and timely contact between the general licensees and the i
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While the Atomic Energy Act gives NRC the authority to request appropriate information from licensees, the Commission had not previously included in its regulations an explicit l l
provision in this regard for generally licensed devices.
The NRC plans to use the new requirements for certain generallicensees to establish a i
registration system. This system will cover generally licensed measuring, gauging and '
controlling devices with quantities of certain radioactive materials posing a higher risk to public safety or of property damage if the device were lost than would other generally licensed devices. The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thickness, density or chemical composition in industries such as petrochemical and steel manufacturing. About 6,000 general licensees possessing about 24,000 devices will come under the registration requirement.
The revision requires the affected licensees to respond to NRC requests for information within 30 days, in most cases.
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ATTACHMENT 8 Daily Staff Notes item 1
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g DAILY STAFF NOTES
' OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS Final Rule Sioned by EDO On ,1999, the Executive' Director for Operations approved a final rule, " Requirements for Those Who Possess Certain industrial Devices Containing Byproduct Material to Provide Requested information," that amends 10 CFR Part 31. This rule explicitly requires general licensees who possess certain devices containing byproduct material to respond, in a timely way, to written NRC requests for information concerning devices that they have received for use under a generallicense. This provision will be used primarily to institute a registration and accounting system for devices using certain quantities of specific radionuclides There have been a number of instances in the past where generally licensed devices have not been handled or disposed of properly. This rule helps to ensure that geperallicensees are more aware of their responsibilities and more likely to comply with the requirements for proper handling and disposal of generally licensed devices. This amendment reduces the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property.
This notice informs the Commission that, in accordance with the rulemaking authority delegated to the EDO, the EDO has signed this final rule and proposes to forward it on 1999, to the Office of the Federal Register for publication, unless otherwise directed by the Commission.
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ATTACHMENT 9 Approval for Publication
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Aporoved for Publication l
The Commission delegated to the EDO (10 CFR 1.31(c)) the authority to develop and promulgate rules as defined in the APA (5 U.S.C. 551(4)) subject to the limitations in NRC Management Directive 9.17,~ Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213,038,039, and 0310.
The enclosed final rule, " Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information," amends 10 CFR 31.5 to add an explicit requirement that general licensees who possess devices containing byproduct material provide the NRC with information concerning products that they have received for use under a general license as requested by the NRC. This provision will be used primarily to institute a registration system for devices using certain quantities of specific radionuclides.
This final rule does not constitute a significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7,8, or 9 Subpart C concerning matters of policy. I, therefore, find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
Date William D. Travers, Executive Director for Operations.
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