ML20217M925
| ML20217M925 | |
| Person / Time | |
|---|---|
| Issue date: | 07/22/1998 |
| From: | Halman E NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Combs F NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20217M898 | List: |
| References | |
| FRN-63FR66492, RULE-PR-31 AG06-1-007, NUDOCS 9910280086 | |
| Download: ML20217M925 (63) | |
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UNITED STATES M Ob -/
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j NUCLEAR REGULATORY COMMISSION o
WASHINGTON, D.C. 20555-oCK1
% %,8 July 22, 1998
~~
MEMORANDUM TO: Frederick C. Combs, Acting Director Division of Industrial and Medical Use Safety Office of Nuclear Material Safety and Safeguards FROM:
Edward L. Halman, Dire Office of Administration
SUBJECT:
OFFICE CONCURRENCE ON A PROPOSED RULE ENTITLED
" REQUIREMENT FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE REQUESTED INFORMATION" The Office of Administration (ADM) concurs, subject to the comments provided, on the proposed rule that would amend 10 CFR Part 31 to add an explicit requirement that general licensees who use certain measuring, gauging, or controlling devices that contain byproduct material provide the NRC with information concerning these devices. We have attached a marked copy of the package that presents our comments.
We have provided a rewritten Summary statement that would comply with the requirements of the Office of the Federal Register (OFR) concerning Summary statement content. We have provided a revised document title that more clearly identifies the subject of the proposed amendment. Finally, we have made a number of editorial changes to the text of the proposed rule in keeping with the President's June 1,1998, memorandum on plain language.
To assist your staff in preparing the list of documents centrally relevant to this proposed rule that is required by NRC's regulatory history procedures, please instruct your staff to place the designator "AG06-1"in the upper right-hand corner of each document concerning the proposed rule that you forward to the Nuclear Documents System.
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
l 9910280086 991022 PDR PR 31 63F'R66492 PDR A
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The Commissioners FROM-L. Joseph Callan, Executive Director for Operations
SUBJECT:
PROPOSED RULE: 10 CFR PART 31 " REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL" PURPOSE:
To inform the Commission that the EDO intends to publish, as directed by the Commission, a proposed rule that would explicitly require general licensees, who possess certain devices containing byproduct material, to provide the Nuclear Regulatory Commission (NRC) with information concerning devices that they have received for use under a generallicense. This provision would be used primarily to institute a registration and accounting system for devices using certain quantities of specific radionuclides.
BACKGROUND 7
Theshue.he., a nuu-, ;f errrr::: " : hnerally licensed devices conta{
radioactive materiayssued under 10 CFR 314have not beenQisposed of(or prepor J
handledf resultyi conc u ed that mor,n, radiation exposure to the)ublic and contamination of property. The staff 0p h d frequent and timely contact between the generallicensee and the NRC gr p'j.
could remedy these problems. On December 27,1991 (56 FR 67011), the NRC published a 4
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proposed rule concerning this issue. The proposed rule included a requirement for generals,i 1
3;p licensees under 10 CFR 31.5 to provide [idTo~rmatior gt th; swuo3i cf the NRG rn-p" g
the regulatory basis for the registration of devices es " " a additional requirements in 10 CFR 32.51a and 32.52 for the specific licensees who ma facture or initially transfer these
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devices to the generallicensees. A final rule was not implem nted because resources o
nefjd -to proper'" implement the pre *ianin' _
ute as roposej-1 anj fc
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CONTACT:
Catherine R. Mattsen, NMSS/IMNS (301)415-6264
,,y,
Jayne M, McCausland, NMSS/IMNS j
(301)415-6219 i
)
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The Commissioners 2-In July 1995, with assistance from the Organization of Agreement States, NRC formed a working group to evaluate the issues related to the loss of control of generally licensed 20 nll e5
=J specifically licensed sources of radioactivity. The working group submitted a final report to NRC concerning its evaluatiorpaod 6n October 18,1996, the staff provided its evaluation of the y
t working group recommendations in SECY-96-221. This report was published as NUREG-1551 l
in October of 1996. On November 13,1996, the staff briefed the Commission on its preliminary l
' views of the working group's recommendations.
On November 26,1997, SECY-97-273 requested Commission approval of the staff's recommendation to develop and implement a registration program for certain 10 CFR 31,5 generallicensees. The staff's recommendation was based, in part, on its evaluation of the recommendations of the NRC/ Agreement State Working Group. In art RM Joead April 13, O
% 1998, the Commission disapproved the staff's recommendation iWOV-9740 and directed the staff to terminate the,rulemaking en 10 CFR 21.5 'hn+=== iniH ted in 1991 except for these-e
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provisions that would enable NRC to request information from certain general licensees to
/jr provide the regulatory basis for inibahun(RM,.ibe Co-!stien directed the s a registration program. The4ubjeefproposed rule L responds to that directive. Alee mTfiat S r
subsequent rulemaking, a registration and followup program for generally licensedN u/fo sources / devices identified by the NRC/ Agreement State Working Group in NUREG-1551 apply fees to these general licensees, and jncorporate requirements foripErI1anent labeling of L 10 sources /Wvices. In addition, the Commission directed the staff to provide a set of milestones for implementin the second rulemaking dercr!had eh^v= There ~ httenee cr0 b;bd:di -
(Attachment 1
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/// A A 4-Ardhar %minThe SRM us the de.elcpment enforcement policy with a short amnesty p
am followed by increased civil penalties for lo a or improperly disposed sources. The 5
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_1 F&si %gier nnne Mr'ha proposed rule b;bdx a^"c:Sfef the,Cg+rppl make these changes to the enforcement policy. The bie"m p S6 vill be rovide()tt the Commission with th; tr.' r6 cad w^"'d M issued concurrently with the final rule.
j DISCUSSION:
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The NRC has authority under the Atomic Energy Act of 1954 to request appropriate information from its licensees concerning licensed activities. However, i& too um vi DCro ?15
'iivamw4no explicit provision to this effect has been included in Part 31. This proposed rule j would add an explicit requirement to 10 CFR 31.5 that genual licensees respond in a timely way l
fTo writterhrequests freco U,e NGC for information concerning devices that they have received for use under the generallicense. This provision will be primarily used to institute a registration and accounting system for devices using certain quantities of specific radionuclides. The criteria for determining which devices would be included in the registration program are those recommended by the working group. The licensees will be asked to verify information I
concerning the identification of devices, accountability for the devices, the persons acting as contact with the NRC, and the disposition of the devices.yMs estimatedf t}1at approximately 6000 general licensees would be required to provide registration informatior M +ha PC.
- 7);c r}oh The proposed rule is intended to ensure that certain generallicensees are aware of and understand the requirements for the possession of deviceo containing byproduct material and I'
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.p The Commissioners 3
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can account for their devices. This communicat' ion would provide NRC assurance of u
accountability on the part of these licensees. $8etter meranaen nn tha p34ef generallicensees v ",,.
of their responsibilities wou;J help bensure4 hat 4he-generaMoensees omply with the requirements for proper handling and disposal of generally licensed de cegand shev d help j
reduce the potential for incidents that could result in unnecessary radia,on exposure to the c,.
public contamination of property.
j COORDINATION: od
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The Office of the General Counsel has no legal objection to the proposed rulemaking. The Office of the Chief Financial Officer has reviewed this paper for resource implications and has no
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objections. The Office of the Chief Information Officer has reviewed the proposed rule for information technology and management implications and concurs with it.
RECOMMENDATIONE:
That the Commission:
1.
Acorove a notice of proposed rulemaking (Attachment 2) that would explicitly require generallicensees who possess devices containing byproduct material to provide the NRC with information concerning devices that they have received for use under the general license as requested by the NRC.
2.
Certify that this rule, if adopted, will not have a significant impact on a substantial number of small er.tities, in order to satisfy the requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
3.
Ngie:
a.
It is my intention to sign the draft Federal Register notice in 10 days from the date of this paper unless directed otherwise by the Commission; b.
The rulemaking will be published in the Federal Reoister for a 75-day public comment period; c.
There has been no coordination of this rulemaking with the Agreement States; as directed by the SRM of April 13,1998, no compatibility of Agreement State regulations is required; the Agreement State compatibility issue will be addressed in the second, tnore comprehensive rule also dealing with this issue.
d.
Neither an environmental impact statement nor an environmental assessment has been prepared for this regulvion because it does not have a significant effect on the environment; e.
A draft regulatory analysis has been prepared and will be available in the Public Document Room (Attachment 3);
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The Commissioners
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' The appropriate Congressional committees will be informed (Attachment 4);
g.
< The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regarding economic impact on small entities and the J
reasons forit as required by the Regulatory Flexibility Act; b.
The proposed rule would amend information collection requirements that are l~
subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These requirements I. ave been forwarded to the Office of Management and Budget for
- approval;-
L 1.
A draft press release will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Attachment 5).
l-L. Joseph Callan Executive Director for Operations i
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- Attachments: 1. Milestones for Registration Program i
- 2. Draft Federal Register Notice
- 3. Draft Regulatory Analysis
- 4. Congressional Letters 5 Draft Press Release L6. Approval for Publication '
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i The Commissioners 4
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The appropriate Congressional committees will be informed (Attachment 4);
g.
The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certificatior. regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act; h.
The proposed rule would amend information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These requirements have been forwarded to the Office of Management and Budget for approval; l.
A draft press release will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Attachment 5).
1 I
L. Joseph Callan Executive Director for Operations Attachments: 1. Milestones for Registration Program
- 2. Draft Federal Register Notice
- 3. Draft Regulatory Analysis
- 4. Congressional Letters
- 5. Draft Press Release
- 6. Approval for Publication DOCUMENT NAME: o:\\mattsen\\glip\\ prop _31.cp u m.,...
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RGB RGB-IMNS RRDB/ADM NAME:
CRMattsen PKHolahan FCCombs DMeyer DATE:
/ /98
/ /98
/ /98
/ /98 OFFICE:
BJShelton JGray JLieberman JFunches DATE:
/ /98
/ /98
/ /98
/ /98 OFFICE:
D/OSP Tech D/NMSS DEDR EDO Ed NAME:
RBangart -
EKraus MKnapp HThornpson LJCallan DATE:
/ /98
.' /98
/ /98
/ /98
/ /98 OFFICIAL RECORD COPY NMSS FILE CODE NO.:--
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ATTACHMENT 1 I
MILESTONES FOR REGISTRATION PROGRAM
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' Milostones for registration program for generally licensed devices Final rule package for this rule
'lo EDO -
four months after the end of public comment period Effective Approximately 7/99 The second comprehensive rule Develop initial draft package 9/8/98 OMB ' package to IRM for review _
'10/6/98'
.lssued for Office concurrence and to Agreement States' 10/27/98 Discuss at OAS meeting 10/98 To'EDO 12/24/98 To Commission 12/31/98 i
Publish in Federal Register and transmit OMB package to OMB (3/9/99) -
End of public comment period 75 days after publication Develop draft final rule package 13 weeks after end of comment period -
To Agreement States for review 18 weeks after end of comment period To Office review 20 weeks after end of comment period To EDO.
25 weeks after end of comment period t
- To Commission 28 weeks after end of comment period I
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1 Automated Registration System j
. Begin Registrations 2/2000 j
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ATTACHMENT 2 FEDERAL REGISTER NOTICE I
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[7590-01-P]
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NUCLEAR REGULATORY COMMISSION 10 CFR Part 31 RIN 3150 - EAA h O[
wh Requirement /forIhh osePossessioq ofi ndustrial l
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-l AGENCY: Nuclear Regulatory Commission.
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ACTION: Proposed rule.
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SUMMARY
- The Nuclear Regulatory Commission (NRC) ropos to amend its regulations #c ol' 1
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bypeeduct meter!c! in certain measuring, gauging, or controlling devices
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a explicit equirel generallicensees w
].eeeee 'heee de" ice te provide MNRC with Dl p op as ed oale a c ald,/t odde Jhc In V "
infor tion conc erning the devic The t 1RC in cade ;v use uns piyvision to provice legal g
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m;;rin; recunt;b"/e devicey cow r., in )
basi to request information fr m licensee:
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j cc, ein qur'i+ie e of epecif".cdior.uchd6 ' nat present a high risk (compare d to other
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g nerally licens ed device of exposure to he public orp1ro erty damajnrin, device were lost".3
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eifa ut / of.ru paa. Je fpc M*
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n initiate an annual re istration program. The rule ropose is intendod to ensure that
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M e: c generallicense es are are of and underst; nd the re irements for the posoession ofldevicesg o >J ehnkd n ah [p!
ur isaIari av" i C r ev C65. vo66ui carvu. inwoovit % 3d a.=-
p rres a n e - - -.,,, ~. y.
re-tssg,n,andling and dispos Pgeneralty-licensed devicec cnd-should he'p a
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p INSERT A z
SUMMARY
- The Nucle.r Regulatory Commission (NRC) proposes amending its regulations to add an explicit requirement that generallicensees who use certain measuring, gauging, or controlling devices that contain byproduct material provide the NRC with information concerning L these devices. The proposed' rule would provide the NRC with a legal basis for requesting
. information concerning devi[res that present a comparatively higher risk of exposure to the public or property damage. ye propose'd rule is intended to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded.
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t redue potential or incidents tha
. re gunnecessary radiation eJposttre4olhe
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s well a ntam. s.
of property.
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DATES: Submit comments by (Insert date 75 days after publication date). Comments received after this date will be considered if it is practicable to do so, but the Commission is able to assure consideration only for comments received on or before this date.
y ADDRESSES: Send commentes by mail nr =ddrasee to the Secretary, U.S. Nuclear Regulatory -
. Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications Staff.
Hand-deliver comments to:.11555 Rockville Pike, Rockville, Maryland, between 7:30 am i
and 4:15 pm on Federal workdays.
You may also provide comments via the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc. gov). This site provides the availability to upload comments
. as files (any format), if your web browser supports that function. For information about the j
-. interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-6215; e-mail CAG@nrc. gov.
Certain documents related to this rulemaking, including comments received and the
. regulatory analysis, may be examined at the NRC Public Document Room,2120 L Street NW.,
' (Lower Level), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking.
FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, 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===
On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its Q
m regulations to provide a generallicens (origina!!yW10 CFR 30.21(c)[for the use of byproduct material contained in certain measuring, gaug or controlling device 3. Under current 0 CFR 31.5) certain persons may receive and use a device regulations,.nowmentained containing byproduct material under this general license if the device has been manufactured jo /*
and distributed ih accordanedwith the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license authorizing distribution of generally if e
licensed devices is issued hawa ope etermin a regulatory authogthat the safety features of the device and the instructions for safe operation of that device are adequate and meet regulatory requirements. The general licensee must comply with requirements for labeling, instructions for use, proper storage or disposition of the devicq;ykitikr some of-thesd devices,
'([ hieak testinghh li ense is also subject toberms and conditions set 4 10 CFR 31.2 v
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- yemt y
deakng-wit general'; cense requirements, transfer of byproduct material, reporting and record cmnn n givw keeping, and inspection. The generallicensee is.de required te bomply with the safety (smr instructions contained in or referenced on the label of the device and 16 have the testing or who if servicing of the device performed by an individual / authorized to manufacture, install, or service these devices.
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I-A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded device. The device is designed with inherent radiation safety features so'that it can be used by persons with no radiation training or experience. Thus, the general license is meant to simplify the licensing process so that a case-by-case determination Lof the adequacy of the radiation training or experience of each user is not necessary.
There are about 45,000 general licensees under the CommisstordLQeneel licence inSL pfC 10 CFR 31.5 who possess about 600,000 devices that contain byproduct material. In the past, 5 f, generallicensees h:.; c~; brra mn'stad__b a regular basis because of the relatively
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small radiation risk posed by these devices and the very large number of general licensees.
IP However, there have been a number of occurrences where generally licensed devices containing radioactive material have not been properly handled or properly disposegef whkh-g j has resulted in radiation exposure to the public and contamination of property) hen a ne e s m,
source is accidentally melted in a steel mill, considerable contamination of the mill, the steel product, and theyastes from the process, the slag, and the baghouse dust, can result. AR
!!'Ernia,-
reed!! Of edof these incidentq aMt%to assess the effectiveness of the generallicense C_..-
NRC conducted a 3-year sampling (1b84 through 1986) of general licen progra gg determine whether there was an accounting problem with generally licensed device users and, if so, what action could be taken. The sampling revealed several areas of concern regarding the use of radioactive material under the general license provisions of 10 CFR 31.5. The NRC Jyaiy pi
.a //c m s-.r c rol ua concluded that ther
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aware f ppropriate regulations or the pe'* Of the hnerally licensed u.cc--
gdequate handl genera; Sen:00) an 2) and account fo c'd m..
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devices / Approximately 15 percentif'alljeneia icensees samp ed could not account for all of
.9 their generally licensed devices. As e.='t e he sa.
hNRC concluded that these n
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problems could be remedied by more frequent and timely contact between the general licensee l
and the NRC.
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' 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 1
10 CFR 31.5 to provide information to the NRC upon request, through whlch a device registry l'
could be developed. The proposed rule also included requirements in 10 CFR 32.51a and t
32.52 for the specific licensees who manufacture or initially transfer generally licensed devices.
Although the public comments received were reviewed and a final rule developed, a final rule i
fhe
.was not issued because ef4aek of cve!!adresources to roper implement the prvvmuus A n.1 thelrule(Vs roposed [ wer.
s r* * /" M O The NRC has 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 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 recommendations. All working group meetings were open to the public. 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 these recommendations, the NRC has decided, among other things, to
- / u p a m u. -
l initiate an annual registration, simi ar,to tggrogam originally proposed in the Decembe 1991 proposed rui es generally licensed under 10 CFR 31 However, the NRC has
. decided to do so only for those devices concidered i present a higher risk (compared to other b
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- generally licensed devices) of potential exposure of the public and property loss in '50 0:se of
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lossdcontrol, initially at4eest, the NRC will use the criteria developed by the working group for h e
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determinidwhich so"reabhould be sehjac+ to the registe, ep%
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This proposed rule wetM present ~r a second round of comme" the proposed additio J
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.of an explicit requirement to provide information in response to requests made by the NR While the proposed rule would apply to all 10 CFR 31.5 general licensees, the NRC plans to i
ont contact enerallicensees identified by the working group for the purpose of the registration i
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p W-program.
1oh,__yNRC ne nnrt of thic nnHca is withdrawing the December 27,1991 proposed rule. NRC 1
plans to review the other provisions contained in the December 27,1991 proposed rule and the recommendations of the working group and develop additional requirements in a separate prepcM rolo fn he icened in the naar fn+nemf g,g,sg Discussion
,, thn i
The Atomic Energy Act of 1954 (AEA), as amended, provL_ the NRC r" '5; ewih%
to request appropriate information from its licensees concerning licensed activities. ' "- -~^
y R 31.5 general lic ver. the Commission has not includedfan ex licit 7e porta n)D Q
- provision in this reg 2rd ja !!: regulationslir, Po131. VQ10 CFR 2.204,30.34(e), and 30.61(a)
N M/W require information from licensees by order or demand, these provisions are not considered appropriate for the initiation of a routine registration program. Aiso,b a previous rulemaking, the Commission (then AEC) had proposed the inclusion of a registration req tirement for generally 5
licensed devices (February 5,1974; 39 FR 4583 Jhc pregusai we fec reg ti tic., prior 4e-bes%e receipt of device in response to comment on that proposal, the Commission decided not to 6
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institute a registration requirement at tS t t s part of the final rulemaking on that action (December 16,1974: 39 FR 43531). Given this history, establishing a device registration dc d
@g/cl gri program without a rulemaking process is also considered inappropriate.
This proposed rule would add an explicit requirement to sectd31.5 that eneral 1
r to licenseesirespond n a time!y way%to written requests from the NRC for information concerning
'N products that they have received for use under a general licensg The NRC intends to use this provision primarily to institute an annual registration program for devices using certain quantities of specific radionuclides.
The proposed rule would require a response to requests within 30 days or such other time as specified in the request. For routine registration 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 e-y, pons Commission may provide a longer Mtim n-~"a " ~ a=
In the unusual circumstance of a significant safety concern, the Commission could demand information in a shorter timgY The appropriate address I n')
g{- /br f esp ct91c fjryg r and phone number for " Eg a requestIfor extensi'on w{be provided in the request for uow/tl information. The NRC is specifically soliciting comments on this time period.
The proposed rule is primarily intended to ensure that general licensees covered by the registration program are aware of and understand the requirements forpe possession of ihr pupried tal woult t
devices containing byproduct materi allow NRC to account for devices that have been p 7he ///c belierr$ f))af jf distributed for use under the general license. iBetter awarent:0 :n the p:". Of generallicensees hof their responsibilities w uld htlp to e,iouim that theIg^n^w0*I'$
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' *- :::: comply with the 7})ij k o,gI requirements for proper handling and disposal of generally licensed deviceg0 p
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reduce the potential for incidents that could result in unnecessary radiation exposure to the x
publi well as contamination of property 4 M d>ve?c eh /dd A m /u se'./ /6 The) licensees w[be asked to erify, as well as' certify, information concerning:
fe identification of devices, such as the manufacturer, model and serial numbers; 1.
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[e persons responsible for compliance with the regulations; and 3
he disposition of the devices.
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While the proposed rule would apply to all 10 CFR 31.5 general licensees (about goul0 45,000), the NRC w[only contact approximately 6000 general licensees, possessing about 24,000 evices. This estimate'is based cn the ucc c criteria recommended by the
-working group for determining which sources should have increased oversight. Requests for information would be sent to generallicensees who are expected, based on current NRC records, to ossess devices containing at least 370 MBq (10 mci) of cesium-137, 3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of any transuranic (at this time, the only generally licensed devices meeting this criterion contain americium-241). The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thickness, density, or chemical compositio ndustriege r-K etrochemical and steel manufacturg The requests will include the information contained in NRC' records concerning the possession of these devices. The licensees will be asked to verify, correct, and add to that information. The NRC records are based on information provided to NRC by distributors under 10 CFR 32.52(a) and from general licensees as required by 10 CFR.31.5(c)(8) or (9). If a generallicensee no longer possesses a device meeting the criteriag
%+epekt, they would expected to provide information about the disposition of strett fhc.
devices previously possessed. Errors in current NRC records concerning these general 8
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licensees could be the result of: (1) errors made in the quarterly reports of manufacturers or initial distributors, (2) general licensees not reporting transfers, or (3) errors in recording transfer information made by NRC or its contractors.
a
/ In, In addition to the 6000 general licensees identified for registration,,NRC may occasionally request information from other generallicensees as conddcrc[n cessary or 3
appropriate ase-by-case bas [
[r example, nvestigating the extent that other users have experienced a problem that has been identified with the design of a particular device model. However,Xsignificant modifications to the registration program to include a larger class of licensees mre er"WenM the nn
,,G;a Would nO! dc 00 uny una ^
pr^"Mc~, :Ser, P ":rr'd 0; :t i;i 0; through rulemaking.
Although the proposed amendment would impose some additional costs on licensees, the NRC has estimated these costs to be minimal. This cost is the estimated administrative cost expended by general li,censees to verify the information requested by the NRC regarding prop o.sre t licensed devices. The NRC believes that theTrule's intended effect ofincreased compliance by general licensees with regulatory requirements and resulting NRC and public confidence in the generallicense program potentially afforded by these new requirements outweigh this nominal i
administrative cost.
The NRC is currently considering additional rulemaking concerning the control and accountability of devices generally licensed under 10 CFR 31.5 and is planning to add to the provisions of this rule in a separate rulemaking in the near future. The recommendations made pla ouW in NUREG-1551 will be considered. That anticipated rule wd1 address fees for registration, additionallabeling requirements for 10 CFR 32.51 licensees, and compatibility of Agreement State regulations in this area. Public comments on this proposed rule should only address the 9
requirements proposed in this action. Comments concerning possible future rulemaking and the cey possible imposition of fees will cai ce addressed in th[finalizhth' rule
-Mfb I fp 1'^
py/ F,.! y -
Public Comments on the Original Proposed Rule The NRC reviewed the comments received on the December 27,1991 proposed rule.
?
There were 26 comment letters received from a variety of sources including private and publicly held corporations, private citizens, citizens groups, the Armed Forces, and State governments.
Thekse (civments have been considered to the extent applicable to this more limited proposed rule and will (ontcw Q be considered in the development of ; -
quent rulemaking phr.r.cd to dca'"
h;ls;uc of k
accountability of devices generally '.
10 CFR 31.5. A detailed analysis of the comments received on the Dece.
W sgproposed rule will not be presented in either action as many of the specific comments pertain to specific provisions that have been withdrawn, much time has passed since these comments were made, and additional opportunity for comment is being provided.
Comments received on the December 27,199gproposed rule demonstrated that there was considerable opposition to the rule as proposed, some of it specifically concerning a registration reqairement. Most of this opposition was related to the breadth of the proposal which would have made the registration program a'plicable to all of the 10 CFR 31.5 general licensees, accounting for as many as 600,000 devices. Some respondents questioned whether this was jt stified or cost effective. Some thought the impacts were underestimated, particularly for general sicensees possessing many devic _s, and that tne provision would have serious impacts on certain industries. Registration was specifically opposed for devices used by the 10
airline industry, self-luminous signs, static eliminators, and some other devices which present relatively low risks.
j The NRC be'::.;; 9 he o king group process ba b;;
aluable in identifying tegorizing devices wdare more likely to present a significant risk of criteria for exposure of the public or contamination of property. Therefore, the registration of devices under this proposed rulemaking would be limited to those devices meeting the criteria recommended by the working group. For the most part, generallicensees using devices meeting these criteria have a limited number of vices that would require registration. The NRC is exploring approaches to minimize the administrative effort for both general licensees and the NRC in implementing this requirement.
- This proposal includes a provision to request an extension to the time interval to provide a complete response to requests for information, if the general licensee is having difficulty in meeting the time limit. This provision was included in response to comments on the December 27,1991 proposed rule. Although this difficulty is much less likely to arise within the 71 limited population of generallicensees covered by the current proposal, the Commission aspeed be h' '.
that the additional flexibility is desirable.
Interim Enforcement Policy As had been planned at the time of the 1991 proposed rule, the Commission intends to establish an interim enforcement policy for violations of 10 CFR 31.5 for licensees who discover and report during the initial cycle of the registration program. This polic wIsu.oM v
pplement the v4d normal NRC Enforcement Policy in NUREG-1600, Rev.1. It w[be issued concurrent with the o"1 11
,, pp
' /P '
d f)p!
l final rule nd remain in effect through one complete cycle of the registration program.
Under the current NRC Enforcement Policy, significant violationgsuch as those involving i
lost sources may result in escalated enforcement action including civil penalties. The interim b
g ulel policy would provide that enforcement action normally wEnot be taken for violations identified by f
a licensee and reported to the NRC prc'/ided th appropriate corrective action is taken. For the k
dime period that the interim policy is in effect, it would also apply to general licensees not subject to the registration requirementQf they identity and report violations and take appropriate
~
r{intenkI corrective action. This change from the current NRC Enforcement Policy islto remove any disincentive to identify deficiencies that might be caused by a concern over potential nnforcement action, This action would be teker
- ourage general licensees to search their facilities to assure sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective action when deficiencies are found. However, where the issuance of a Notice of Violation (NOV) without a civil penalty falls within the definition of JM L
" escalated enforcement action", an NOV still may be issued if thebaff believes that taking this action is justified by the safety significance of the violation or the need to record and document l
the general licensee's corrective action in the formal manner required in a response to an NOV.
nowId Escalated enforcement action wee considered for violations involving failure to provide l
the information requested, failure to take appropriate corrective action, or for willful violations including the submittal of false information. Sanctions in those situations may include significant civil penalties as well as orders to limit or revoke the authority to possess radioactive sources j
under a general license.
I At the same time, the Commission intends to increase the civil penalty amounts specified
{
in its current Enforcement Policy in NUREG-1600, Rev.1 for violations involving lost or 12
' improperly disposed sources or devices. This is to ensure that such civil penalties are significantly higher than the costs avoided by the failure to properly dispose of the source or device.
Agreement State Compatibility Under the " Policy Statement on Adequacy and Compatibility of Agreement State pooPNe"(
Programs" approved by the Commission on June 30,1997 (62 FR 46517), thishule 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 oversight program is expected to include provisions that will require a higher degree of compatibility. This will be considered in a subsequent rulemaking to add more explicit requirements for the registration program and additional provisions concerning accountability of generally licensed devices.
Environmental impact: Categorical Exclusion The NRC has determined that this proposed rule is the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii). Therefore, neither an environmental imp?ct statement nor an environmental assessment has been prepared for this regulation.
13
1 Paperwork Reduction Act Statement l
This proposed rule would amend the information collection requirements that are subject
- to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These requirements have been forwarded to the Office of Management and Budget for approval.
Public reporting burden for this collection of information is estimated to average about 20 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commissica, Washington, DC 20555, and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-3019, (3150-0016 and 3150-0001), Office of Management and Budget, Washington, DC 20503.
Public Protection Notification W
If9 dncomant osad tn :.pos 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.
14
Regulatory Analysis The NRC has prepared 'a draft regulatory analysis for this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The comments received on the earlier draft regulatory analysis have been considered to the extent that they apply to this more limited action, The regulatory analysis is available for inspection in the NRC Public Document Room,2120 L Street NW. (Lower Level), Washington, DC. Single copies of the analysis may be obtained by calling Jayne McCausland, U.S. Nuclear Regulatory
~
i 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 As requireg by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies f ac00
a f a d op I d p v.o oitI that thishule bav,e a significant economic impact on a substantial number of small pop om' rpe ci fic.
entitiesc Thiske would require generallicensees who have received evices to respond ro ld s
to requests for information from NRC. The proposed rulefapplyto the approximately 45,000
'/
- persons using products under an NRC general license, many of whom may be classified as i
f small entities. HowcVer, the NRC intends to uce :h;; ::quec..v,c.,.1 req'uest registration i
'information from only approximately 6000 of these generallicensees; this ec,uM ',iduJu l
l id-t a' bout 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 the requirements on any generallicensee would be a 15
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- f[
d' ll
- pfri l
negligible increase in administrative burden.' The rule is proposed to belt ure that C
general licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.
l Backfit Analysis l
The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this proposed ru e and, therefore, a backfit analysis is not required because these amendments would not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects en 0 CFR Part 31 pyproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements,
' Scientific equipment.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. SR M
pnopoo )
1md 553, the NRC isradopting the following amendments to 10 CFR Part 31.
n PART 31 GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL
)
- 1. The authority citation for Part 31 continues to read as follows:
1 i
l l
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0
Authority: Secs. 81,161,183,68 Stat. 935,948,954, as amended (42 U.S.C. 2111, 2201,2233); secs. 201, as amended,202,88 Stat.1242, as amended, 1244 (42 U.S.C. 5841,'
5842).
Section 31.6 also issued under sec. 274,73 Stat. 688 (42 U.S.C. 2021).
2.' Section 31.5 is amended by addin'g paragraph (c)(11) to read as follows.
10 CFR 31.5 Ccrtain measuring, gauging, or controlling devices.2 i
j (c) 1 (11) Shall respond to written requests from the Nuclear Regulatory Commission to provide information relating to the generallicense within 30 calendar days of the date of the 1
request, or other time specified in the request. If the general licensee cannot provide the h.il requested information within the allotted time, it within that same time period, request a longer period to supply the information and provide a justification as to why it cannot comply.
Y Y
y f
l 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.
17-L
f.'
l,
.f i
, Requirements for the P ssion of Industrial Devic ontaining Byproduct
Subject:
Ma er' I(RIN 150-XXXX).
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Dated at Rockville, Marylant this day of
_1998.
For the Nuclear Regulatory Commission.
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(.:Y c r /
,o
- L. Joseph Callan, Executive Director for Operations.
. ~..
l 18 i
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I l
l ATTACHMENT 3
- REGULATORY ANALYSIS i
I I
e
i' REGULATORY ANALYSIS:
REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL 1 STATEMENT OF THE PROBLEM
1.1 BACKGROUND
On February 12,1959 (24 FR 1089), the U.S. Atomic Energy Commission (AEC) amended its regulations to 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 thickness, density, level, interface locationf radiation, leakage, or qualitative or i
quantitative chemical composition or for producing light or an ir"1ized atmosphere. The devices must be manufactured in accordance with the specifications contained in a specific license i
unJett issued either by the Commission p=r* t[10 CFR Parts 30 and 32, or by an Agreement m
State. There are app oximately 45,00 k0 CFR 31 ' general licensees," i.e., persons possessing and using such devices under the general licens These general licensees possess an estimated 600,000 devicegd Ne nrn""^^
)
A general licensee 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 M
testing or servicing performed by the supplier or other specific licensee authorized to Jhc manufacture, install, or servicesweh devices. Generallicensees may not abandon devices and I
F tM
, p'
(C' 1
must maintain records testing and servicing of the device. Generallicensees must also tv nport damageTor loss of devices.
t The NRC is notified when specific licensees transfer devices containing byproduct r nd c u
material to general licensees through quarterly reports submitted pursuert M0 CFR 32.52(a).
1 hese reports identify each generallicensee 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 generallicensee); the type of device transferred; and the quaniity and type of byproduct material contained in the device. Under compatible Agreement 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 generallicensees to transfer or dispose of an/n the generally licensed devices only to the holder of a specific license pureu2nt--t[ 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 I dgeneral licensees to transfer stretT' devices to other general licensees, but only if the device remains in use at a particular location b e rn e-or the device is held in storage in the original shipping container p initial use. In either case, transfers of devices by generallicensees must be reported to the NRC within 30 days of the transfer. No report of a transfer is required if a generally licensed device is transferred to a specific licensee in order to obtain a replacement device. The specific licensee making the transfer is required as part of its specific license to maintain records of the transfer and to be accountable for all radioactive material in its possessi in.
2
c ic(
NRC Study of Conformity with General License Conditions The NRC traditionally has had little contact with generallicensees. The NRC staff c, e asi believes that this is why many general licensees Wwke aware f their responsibilities under a generallicensehesu/ m' this.
n ltgn incidents of mishandling and improper
'E : 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 M
activities.' AnhoK most instances, exposures to the public have not been significanto pne(Mp y & /b-c/enta a en*
thgtoexposures would not have occurred had Bere bed proper handling and dispos np of 3
ig The Commission conducted a study from 1984 through 1986 (General License Study) to a //m.
- ascertain the extent of compliance with generailicense conditions w t became aware of a few incidents where control over generally licensed devices was lost. The results of the study were discussed in SECY-87-167, dated July 9,1987, and in SECY-89-289, dated r-JHhmn i
- September 14,1989. WhM current regulations (10 CFR 30.52) allow for the inspection of i
licensees possessing byproduct material, the Commission has not inspected generallicensees on a regular basis. This is primarily because of the large number of such-Mef e
's licensees and the low risk presented by most of these devices. The Commission hac very-f limited knowledge asdwhether the general licensees are complying with the de: and %
y r /J jp,ife0Q 64 regulations pem;; to the proper use and disposal of generally licensed devicesA Because of the broad range of devices covered under 10 CFR 31.5, the study was
' divided into two parts. The first part covered industrial gauging and measuring 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 3
l L
use, such as self luminous signs', analytical instruments such as x-ray fluorescence spectrometers or liquid scintillation spectrometers, and smaller-scale thickness, density, and l
$\\ G level gauges.-[ summary of the results of the study presented below is based on an unpublished NRC report entitled " General License Study Report."
1.2.1l Part i Results The Part I study included 228 site surveys of generallicensees by the study task force
- and 132 inspections conducted by NRC regional offices; Some greement 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@of these general' licensees could not account for all of their 4
F "'#
i A majority of thes generallicensees either did not notify the NRC of transfers of their gauges improperly transferred their gauges.
At least 2 of these generallicensees were not performing required leak tests or maintaining leak-test records, or they were not inspecting a gauge's on/off shielding mechanisms or not inspecting them as required.
Agreement States reported incidents of thickness gauges being found in landfills and, in one case, even in an abandoned paper mill.
1.2.2 Part ll Results Although Part 11 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 4
l
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 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 one inch in diameter. Ninety-eight interviews were conducted of persons who possess these types l
of devices. Tne findings of Part il are summarized below.
Nonconformity with 6 eral license conditions was very widespread.
Only 16 /o of the generallicensees for exit signs were aware of the regulatory requirements.
Manufacturers and stributors frequ ntly underreported the number of exit signs sold to generallic nsees. Generallic qsees (electrical distributors and contractors) re rted having about 30h) more signs than were listed in quarterly reports of th manufacturers.
Three cas involved missing sources from beta backscatter gauges.
Only 45 o of those surveyed for backscatter gauges were aware of the general
+
license conditions.
Vendor reports did not accurately reflect the number of radioactive sources in the possession of generallicensees. Therefore, when sources were returned to the manufacturer for disposal by general licensees, the NRC was not always notified. Hence, NRC records were not always accurate, i
i 5
-1.3 Subsequent Actions On December 27,.1991 (56 FR 67011)l the NRC published a notice of proposed
)
rulemaking regarding the accountability of generallicensees under 10 CFR 31.5. It proposed a 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.
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 not issued because of i=4 nf au=H=
resources t properl implement the prvvmune cf th(
[
/Ybe The NRC has e issues related to the loss of control of generally i
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 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 recommendations. All working group meetings were open to the public. A final report was completed in July of 1996 and published in October of 1996 as NUREG-1551, ' Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices." The recommendations of the working group provide a major basis for this rulemaking.
6
=
Some of the relevant conclusions of the working group are:
. 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.
jhc s NRC also plans to develop a more comprehensive rulemaking to more completely address issues concerning generally licensed devices. Other recommendations of the working group are to be considered in that action.
i 2 OBJECTIVES The objectives of the amendments to Part 31 are to ensure that certain general i
licensees are aware of and understand the requirements for possession of generally licensed J
devices containing byproduct material and to better enable the NRC to verify the location, use, yhf1C and disposition of sddevices. The intent is to reduce the pessibility of the devices being l
improperly transferred or inadvertently discarded. This may reduce unnecessary radiation l
exposure to the public and unnecessary expense involved in retrieving the items, particularly in j
l the scrap metal stream, as well as to avoid the contamination of steel mills, metals, and waste l
l products.
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j_
3 ALTERNATIVES l
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 l
l with this alternative. No action, of course, does nothing to add'ress identified concerns.
I
[
Often the only communication between a general licensee and the NRC is through the requirement that the NRC be notified when a device containing byproduct material is 1
i t
transferred. information notices have been sent and inspections have been made but only rarely.
l As discussed in Section 1.2 of this analysis, generallicensees have a lack of awareness l
l 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 I
i
. disposition of generally licensed devices. This, in turn, has resulted in radiation exposure to the public and,-in some cases, entailed expensive investigation, cleanup, and disposal activities. In l
l lig'nt of this, no action would not be appropriate.
i l'
j 3.2 Non-rulemaking alternatives L
' There are a number of ways that the potential problems of lack of awareness of regulatory requirements on the part of generallicensees could be addressed. Guidance could be provided in a nurt.ber of formshowever, only periodic contact with the general licensees would be expected to have a significant impact on the level of awareness of requirements. The f
most appropriate means to remind users of their responsibilities would be periodic issuance of information notices owever, these information notices may not reach all users. While 10 CFR 32.52 requires that specific licensee distributors report to the NRC or the Agreement 8
1
State agency the name and/or title of the individual who constitutes the point of contact
' between the general licensee and the NRC, or the Agreement State agency, the General
. License Study indicated that this individual, who is frequently in the purchasing department,
' often did not inform the individual who uses the device of the general license conditions.
Moreover, the study indicated that personnel turnover frequently eliminated the organization's knowledge of the license conditions. ' For similar reasons, information notices may also not b rea u e reach.the appropriate person within the organization of a general licensee r he contacts
' provided in the specific licensees' quarterly reports are frequently not the individuals
' responsible.for, or knowledgeable of, the devices after they have been received and are being used.
Even when generallicensees are aware of their basic responsibilities concerning the
. devices, there may be other factors contributing to noncompliance with requirements. For
' example, the cost of disposal may cause some general licensees to dispose of devices
- improperly, it is important that the general licensees understand that the Commission will hold
- them responsible for these devicesc increased inspection of general licensees and I
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.
None of these actions would result in a high degree of accountability for these devices.
. A registration system together with followup would be more effective in terms of accountability, and would provide a basis for more efficient use of inspection and enforcement efforts.
4 However, for those devices not subjected to a registration requirement, some increased contact l
l such as an occasionalinformation notice may be appropriate.
I-9 1
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l-3.3 Rulemaking to modify reporting requirements This alternative would amend 10 CFR 31.5 to help ensure that devices containing
. byproduct material are maintained and transferred properly and are not inadvertently discarded.
The general mechanism to be used is to require generallicensees to verify compliance with j
)
certain conditions imposed by the generallicense.
- jn l
The amendments, ya newswbparagraph
) to 10 CFR 3 would require a l-generallicensee to respond days (or as vu ~..... ymneu in the reque 0
l requests from the NRC for verification of information relating to the general license and the generallicense 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 would be 'made for verification of the information
-))y,Y
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currently on record concerning devices containing byproduct material w ave been transferred to the general licensee. The general. licensee would verify, correct, and add to the information, as necessary, and port on the disposition of devices no longer in the organization's possession. This process would offer greater assurance that a general licensee
. 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 would 1
i
. 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.
The registration conducted under this ruiemaking will not completely address the factors p
discussed above concerning knowledge of the regulations reaching the appropriate persong jowever, a subsequent rulemaking is planned which will consider changing the suppliers' l
5 10 i
1 reporting requirements to provide information regarding a person with operational responsibility
.for the devices and a backup to this person, rather than simply a point of contact.
- 4. CONSEQUENCES i
quPWO d
4.1 Benefits of Proposed Alternative
' gg0 Thehevisions are intended to bMMr =L. understanding of and compliance with the I
. general license requirements, and thereby reduce the likelihood of incidents resulting in
' unnecessary exposures to the public, and contamination of property. Rudhgfese revisions a
will better enable the NRC to verify the location d disposition of these devices, am thereby 7 gins confirnithe efficacy of the generallicense regulatory program. The primary benefits of this proposed 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 studies conducted are adequate to peices het ha<e bue quantify an.overall net cost ofhmproperly disposed ors 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 proposed 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 proposed action is based on experience (as reported by the steel indus' try).
Uncertainty in these estimates comes from a number of factors including:
11 i
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The number of incidents of meltings reported is small overall; thus there is considerable statistical uncertainty ~in how representative the costs are of future costs averted.
The likelihood of loss may be different for specifically and generally licensed devices and for different categories of devices. However, once a melting has occurred, it usually cann t be determined whether a generally or specifically licensed device was involved.
The cost of a cleanup depends on the type of steel mill; e.g., experience reported did 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 4
'$100 million for a single incident.
The likelihood of meltings depends on the level of effort on the part of metal manufacturers and recyclers in monitoring for radioactive sources in scrap, which has generally increased over time, particularly at larger mills.
4.1.1' Radiation Exposure Averted Benefit 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 someone else to radiation, in some cases, i dividuals 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 4
i gauge contains radicactive material, The generallicense in 10 CFR 31.5 requires that the generallicensee maintain those labels. kLtheManm of sh dowever, the j
i cautionary languag'e can become corroded and unreadsole 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 material.
12 1
If a generally licensed gauge were improperly transferred ~or disposed of such that it became available to a member of the general public, no significant radiation exposure would 4
result providekthe radioactive material sealed source remained in the gauge and the shutter mechanism remained closed. In addition, temporary exposure to an intact gauge should not 7hc nn c cause a significant radiation dosg, a[would normally include a warning label with a radiation 3
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 result in doses of a few rem to doses that are life threateningitgpeum, the likelihood of N
situations which could result in the highest doses is extremely small.jNo incidents in the U.S. to date have resulted in doses in the upper ranger-arid (
j Based on a June 1994 PNL report, " Peer Review of Improper Transfer / Disposal Scenarios 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 I
cesium-137 within this category of 883 mci using data from the General License Data Base on l
I devices registered in the Sealed Source Device Registry during the period 1987-1992. Gamma i
i gauges were chosen for the example analysis as representative of relatively high risk sources amongst generally licensed devices. The: a were very preliminary estimates. The data has i
known errors and the average activity per device being distributed has declined.
l l
l 13 1
i
n i
h Although the potential exists f'or individuals in the public to receive a very significant g Mfwd exposure, the probability is very low.- Thisfrule would further reduce the probability of
, inadvertent exposures.
1
][
4.1.2 Economic Benefits 3
There is a cost savings to industries' might inadvertently come into possession of s
"an improperly disp M device. The most significant of these would be the avoidance of a l
melting of a source and resulting contamination of a steel mill and its products and wastes.
Based on the known incidents in the period 1983-1995 involving the nuclides for which registration would be required, the cost of decontamination and cleanup of these incidents 1
(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 implemented.. If this rule covers 2 of h evices contributing to the melting experience to date (since this rule addresses only devices in NRC-regulated States and some of the melted
~ devices may have been specifically licensed) and reduces the rate of incidents involving those Ldevices by half, the average annual cleanup costs of $12 M would be reduced by about $1.2 M i
per' year.
- There are other costs, though less significant, associated with lost sources which could
~
i de reduced by this rulemaking.
4The rulemaking should also reduce the number of orphaned sources. The cost of j
disposalin the case of orphaned sources falls on parties other than the user of the device, such E as government agencies, e. g., EPA or DOE, or individuals or organizations who inadvertently l
l come into possession of a device.
i 14
- r
1
.-These projected savings would not be entirely attributable to implementation of the rule, b' t also to th6 planned increase in inspection and enforcement efforts, u
4.2-Costs of Proposed Alternative p&
- inh,o),wr-p The 10 CFR 31.5 result in costs to generallicensees and to the i
Comniission. The're also are costs to the Commission associated with the rulemaking process.
4.2.1 Coists of Revisions to 10 CFR 31.5 to General Licensees Registration process:
The revision requires general licensees to respond to requests from the NRC to verify information related to their general licenses. This information can help the NRC confirm that the generallicensees still possess and are in control of their generally licensed devices i
containing byproduct materials and are meeting the generallicense conditions imposed by the i
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 Cornmission's records.
The cost to industry would entail a small annual administrative cost to each of
~
approximately 6000 general licensees. The General License Study found that the average time required to locate and verify license conditions for all devices in the possession of a general licensee was approximately 30 minutes. The general licensees included in the registration t <
requirement'as proposed in 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'
-15 d
I t
?
This estimate assumes that the general licensees are in compliance with the existing requirements in 10 CFR 31.5. For so'me general licensees, particularly in the first year of responding to the' registration request' more effort would 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.
Miscellaneous one time requests:
1 In additio'n to the registration program, there may be an occasional need to re other information from general licensees under this provision. /his might involve r example, 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 oflicensees were envisioned, the 1
Commission would not do so using this provision but would do so through rulemaking. It is J
estimated that no more than 100 such requests per year on average would be made. This l
could include any of the general licensees under 10 CFR 31.5. As the type of information requested would vary and would not be a routine request as in the registration process, the time to respond would vary and may be longer on average than the routine requests. In the unusual
? circumstance of a significant safety concern, the Commission could demand infonration 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 proposed rule would provide that if a generallicensee cannot respond to the NRC's request within the allowed time limit, general licensees may request an extension of time to respond. For the.most part, general licensees using devices for which registration will be 16
I i
requested have a limited number of ~such devices.' Thirty days would usually be provided for routine registration requests it should be quite rare that an extension beyond the time allowed L would be needed. Also, few incidents are expected where information might be requested from other licensees. Thus, it is estimated that only about 25 licensees would request an extension each year. The NRC estimates that the extension process would average about 30 minutes.
This includeshe time to research the subject, draft the correspondence, if the request is to be t
made in writing, and any subsequent communications with the NRC. In some cases, a fairly simple phone call may suffice.' The cost of this effort would 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 4.2.2 Operational Costs of Revisions to 10 CFR 31.5 to NRC i
i Registration process:
1 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 possession of the generallicensees. It is assumed that the NRC uses the information provided by the specific licensees that is stored in the directory and that each request is computer generated. When the NRC receives a response from a generallicensee, it will log in the 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 53.00 per general licensee (averaging roughly 3 minutes per request, $56/ hour).
Cost = 6000 x S3.00 = S18,000
($56/ hour is assumed because of the administrative / clerical nature of the work.)
This estimate assumes that all general licensees comply with the requirement. The
. number of general licensees not responding or responding inadequately is expected to be 17
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/
greatest in the first year (about h) and beclin in subs quent yearhe cost of followup for noncompliance is discussed fMr be' w.
In a dition, number of gen rallicensees may have difficulty' accounting forIde ice ive()1h[n mb y have rece tr would also be l
greatest in the first year (adding estimated 10 to thos a requiring follow
), and fewer in
~
h*
7p et subsequent years.. ' total of 1 Mof eral licensebs needing followuis based in part on the General License Study =..d subsequent expe ience of some Agr ement States W
amt Jhe w
have initiated enhanced oversight programs.
1 in addition, particularly in the first year or so, ther may be calls from general licensees requesting clarifications regarding the registration pro ss as well as other aspects of their
~
responsibilities under 10 CFR 31.5. Assuming 3 / of all generallicensees r ceiving a request for information call for technical assistance in the first year, and one-third of Ihese' require 15 minutes to respond, and the remaining average 1/2 hour of staff time, ab ut 750 hours0.00868 days <br />0.208 hours <br />0.00124 weeks <br />2.85375e-4 months <br /> of 1
additional staff time may result at a cost of approximately S42,000. After th4 initial implementation, this would be 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@ averaging 15 minutes) or ' roughly S8400.
Miscellaneous one time requests:
For the occasional requests for information from general licensees made on a l-
~ case-by-case basis under 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 t
=
group of licensees for a padicular type of information hkely relating to a particular device or i
device type..lf 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 would
- 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 570/ hour = S3500, 18 l
D
$70/ hour is used as it involves primarily time on the part of a professiorel reviewer.
Extension requests:
The cost to the NRC of processing requests for extensions is estimated to average 3O 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:
' 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:
It is expecte %t Mcrc t;"! be a significant cost for followup after the registration process is initiate The cost to NRC will come primarily from follow-up in cases where licensees either do not respond or cannot account for devices they have received,4 and reconciliations of discrepancies between current NRC records and the registration information submitted by general licensees.' Most of this is not a direct cost of this rule, but a means of enforcing existing requirements. In fact, 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 generallicensees randomly). Although the Commission plans to increase inspection and ' enforcement actions as part of an overali effc/t to improve. oversight of these generallicensees, most of the costs of this increased effort are not a direct result of this rulemakinhst of the effort will be followup related to lost or improperly disposed sources.
NRC would 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, 19
First Year:
[ ')
In the first year, it is estimated that 6000 general licensees will be contacted and that a
xim ill require followup efforts because of either nonresponse or discrepancies between th formation in the NRC records and the reports of the generallicensees.
If the followup avera
} hours effort at $56/ hour; Cost = 6000 x 0.05
.urs x $56/hr. = S33,600.
\\
cond Year:
In the econd year, the NRC would requ verification from the same 6000 general licensees notified t irst year, as well as any new ge Ilicensees added to the database j
meeting the criteria for inclusi a result of quarterly trans reports from the suppliers.
In the second year, a followup rate of 2(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, = S13,440 Third and subsequent years:
The NRC would continue to request verification from the entire!st of generallic sees
- 16. the database. In the third and subsequent years, the need for followLp is estimated at ih 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.
d b
4.2.3 NRC Development and Implementation Costs NRC development costs are the costs of preparing a regulation its promulgation 7brc and implementation.
costs may include expenditures for research in support of the
)pt,/nt r// p regulatory action, publishing Wim nf rulemakingfre(sponding to public comments, and 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 re-performed and dealt with a broader range of issue e costs due' are considered outside 20 1
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 professional staff members expended in developing th[Es rule.
NRC implementation costs are those " front-end" costs necessary to effectuate the proposed actior y may arise from the necessity of developing procedures and guidance to assist 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, which is considered as i
a sunk cost. Although the computer database must be updated in order to implement this rule, and this will be done in a way to particularly accommodate a registratioc. ; rocess, the database inust bt
!c !" need Eupdat#pn any re if it is to provide a reasonable information base for inspection a/
and enforcement and regulatory actions 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 are not estimated here.
The total development and implementation costs for this rule and associated guidance preparation is estimated as: 5189,000 (1 % professional staff year x $126,000).
5 DECISION RATIONALE It is recommended that this action be adopted because it represents a reasonable means for the Commission to fulfill its obligation to protect public health and safety, property, and the environment. It would bc imp!cm:nted ter ensure that certain gene allicensees are aware of those requirements with which they must comply provirfe the information on the location, use, and disposition of generally licensed devices needed to confirm the efficacy of the general license regulatory program and the estimates of low risk from these devices. The rationale for this recommendation follows.
21 l
Y The reru!!! nf f. General License Study conducted by the NRC indicated that there is noncompliance with the generallicense requirements contained in 10 CFR 31.5(c). Seeh-75I5 noncompliance presents a risk of low,but avoidable exposure of the public to radiation plus a low probability of significant exposure as a consequence.of improper handling or disposal of the devices generally licensed. The Study revealed that a major reason for noncompliance is that users of the generally licensed devices are unaware that there are regulatory requirements associated with the possession and use of these devices.
tJ This regulatory action wfe$tablish a reason 1ble procedure to ensure that general licensees are aware of the provisions associated with the generallicense 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 would provide confidence that the use of generally licensed devices is being regulated in an appropriate manner.
dis regulatory action would result i up-front Ms stimate met :
ca development and implementation costs to the Commission of $189,000 and annual costs to industry and'the Commission of $103,125 snd S37,320 respectively, with somewhat higher costs in the first two years of implementatiogmed!y.mu.pnm lack of awm n ;; :nd -
r$6"%"nra "*h avidinn ra~';" ~.:n'.:)_ Although the NRC estimates that the overall risk j
associated with these devices is small and, therefore, any risk reduction realized through
- improved compliance with the Commission's regulations by general licensees will also be small, there is some probability of significant dose to the public from incidents resulting from loss of 22 l
4 devices. The staff has concluded that the benefit of increased confidence in the efficacy of the
~
r
. generallicense regul5 tory program outweighs the nominal cost per device. The benefit to be realized even further overshadows the nominal costs'when considered in light of the contribution of this action to the possible avoidance of the substantial cleanup costs which have
[. [ : occurred t$ecause of past improper disposition of generally licensed devices. If this rule covers j
of the devices contributing' to the melting experience to date and reduces the rate of incidence involving those devices by half, the average annual cleanup costs of $12 M would be
- reduced by about S1.2 M per year from the implementation of this rule and the increased inspection and enforcement efforts that 'are also planned.
6 lMPLEMENTATION The regulatory action is not expected to present any significant implementation problemsc The computerized directory that would be required has already been implemented
- by the Commission. However, it is outdated and will require improvement or replacement; this would be the case if it is to be useful at all whether this rule is made effective or not. General licensees will be sent a copy of the final Federal Reaister notice.
'7 EFFECT ON SMALL ENTITIES
..As was discussed in Section 4.2.1 of this analysis, the action will have some economic l
impact on generallicensees of devices containing byproduct material. There are up to 45,000
.j l-i l.
. general licensees under 10 CFR 31.5 of which 6000 will be routinely requested to verify i
i l
. information, some of whom may be "small entities" within the meaning of the Regulatory Flexibility Act (96-534). However, the economic impact on these entities would not be significant.
Jy,2@
23 o
o
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 would total about $100,000/yr, it is estimated that there are approximately 24,000 devices in the possession of the Cor.1 mission's general licensees which will come under the registration requirement. The average Oost to the generallicensees per device per year is about $4.00. Therefore, the action would nct have a significant economic impact on small entities.
1 l
i 24 l-t
i i
ATTACHMENT 4 CONGRESSIONAL LETTERS
)
fn U%
[
. UNITED STATES NUCLEAR REGULATORY COMMISSION f
WASHINGTON, D
- 2055.%4001 f
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
)
Dear Mr.' Chairman:
Enclosed for the information of the Subcommittee 'is a copy of a Notice of Proposed
' Rulemaking to be published in the Federal Reoister in the near future. The Nuclea Commission is proposing to amend 10 CFR Part 31 to-expictlpegwe certain general
\\ y/
r licensees who possess devices containing byproduct material)srprovide the NRC with gp6< ' */ *' y,,.g information concerning devices that they have received for use under a general license as requested by the NRC. This provision would be used primeri' to institute a registration system
/h *
- for devices using certain quantities of specific radionuclides.
This amendment would allow NRC to account for devices which have been distributed for use under the general license and 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 i
a significant burden on licensees.
Sincerely,
(
Dennis K. Rathbun, Director Office of CongrL. - al Affairs
Enclosure:
Federal Reoister Notice i
- cc: Senator Bob Graham -
1
k The Honorable James M. Inhofe, Chairman l
Subcommittee on Clean Air, Wetlands, j
Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister in the near future. The Nuclear Regulatory Commission is proposing to amend 10 CFR Part 31 to explicitly require certain general licensees who possess devices containing byproduct material to provide the NRC with information concerning devices that they have received for use under a generallicense as requested by the NRC. This provision would be used primarily to institute a registration system for devices using certain quantities of specific radionuclides.
This amendment would allow NRC to account for devices which have been distributed for use under the general license and reduce the potential for incidents that could result in unneenssary 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 signi5 cant burden on licensees.
Sincerely, 1
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Original letter sent to: The Hon. Dan Schaeffer Federal Reaister Notice Chairman, Subcommittee on Energy and Power cc: Senator Bob Graham DISTRIBUTION: [O.\\MATTSEN\\GL1P\\ PROP _31. CON]
CJPaperiello DACool JPiccone PHolahan CRMattsen JMcCausland NMSS/RGB NMSS/RGB NMSS/RGB NMSS D:NMSS OCA CRMattsen JPiccone DACool EKraus MKnapp DKRathbun
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,4>
t UNITED STATES NUCLEAR REGULATORY COMMISSION
' WASHINGTON, D.C. 2055tH)o01 4.....
. The Honorable Dan Schaefer, Chairman I.[fk f
Subcommittee on Energy and Power
/?
1
- Committee on Commerce SYe
'4'
)
United States House of Representatives '
Washington, DC 20515
~~
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister in the near future. The Nuclear Regulatory Commission is proposing to amend 10 CFR Part 31 to explicitly require certain general licensees who possess devices containing byproduct material to provide the NRC with
~information concerning products that they have received for use under a general license as.
requested by the NRC. This provision would be used primarily to institute a registration system for devices using certain quantities of specific radienuclides.
This amendment would allow NRC to account for devices which have been distributed for use under the general license and 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.
1 Dennis K. Rathbun, Director Office of Congressional Affairs i
Enclosure:
Federal Reaister Notice i
cc: Representative Ralph Hall
i I:
The Honorable Dan Schaefer, Chairman -
Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Ee. deral Reoister in the near future. The Nuclear Regulatory Commission is proposing to amend 10 CFR Part 31 to explicitly require certain general licensees who possess devices containing byproduct material to provide the NRC with
- information concerning products that they have received for use under a general license as
- requested by'the NRC. This provision would be used primarily to institute a registration system :
for devices using certain quantities'of specific radionuclides.
This amendment would allow NRC to account for devices which have been distributed for use under the general license and 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 er the public and is not expected to impose a significant burden on licensees Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
' Federal Reoister Notice cc: Representative Ralph Hall i
DISTRIBUTION: (0:\\MATTSEN\\GL1P\\ PROP _31. CON]
CJPaperiello DACool JPiccone PHolahan CRMattsen JMMcCausland NMSS/RGB NMSS/RGB NMSS/RGB: NMSS D:NMSS OCA CRMattsen JPiccone DACool EKraus MKnapp DKRathbun
/ /98
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/ 198 L
c-ATTACHMENT 5 DRAFT PRESS RELEASE
\\
1
l I
I Draft Press Release 1
NRC REVISIONS TO GENERAL LICENSE FOR BYPRODUCT i
MATERIAL IN CERTAIN DEVICES The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the use of byproduct materialin certain measuring, gauging, or controlling devices ts.
- pyn jkV explicity require [ general licensees who possess these devices % provide the NRC with information concerning the devices. The NRC intends to use this provision institute a registration system for the devices containing cedain quantities of specific radionuclides that present a higher risk compared to other generally licensed devices of exposure to the public or property damage if a device were lost. Th rule propose is inter.ded to ensure that generallicensees are aware of and understand the requirements 'or the possession of devices containing byproduct material and can account for their de' :ces. Better avisan;;;;; en the,.;.1
- /hij
@h=== "ce crer + hair r::p;nO,l.;,espould helpp ensure that they comply with the requirements for proper handling and disposal of generally licensed devices and should help reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property,
6 ATTACHMENT 6 APPROVED FOR PUBLICATION
J s-Acoroved for PublicatiQD
' 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.
j..
g fp F The enclosed proposed rule,." Requirements for th. Possession of Industrial Devices Containing
' Byproduct Material" would amend 10 CFR 31.5 t explicittf require generallicensees who j
possess devices containing byproduct materialpprovide the NRC with information concerning j
products that they have received for use under a general license as requested by the NRC.
This provision would be used primer!!" to institute a registration system for devices using certain quantities of specific radionuclides. k This' propose' rule.does not constitute a significant question of policy, nor does it amend d
regulations contained in 10 CFR Parts 7,8, or 9 Subpart C concerning matters of policy. I,
{
t therefore, find that this rule is within the scope of my rulemaking authority and am proceeding tn issue it.
Date -
L. Joseph Callan, Executive Director for Operations.