ML20062H450
| ML20062H450 | |
| Person / Time | |
|---|---|
| Issue date: | 11/27/1990 |
| From: | Norry P NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| To: | |
| References | |
| NUDOCS 9012040316 | |
| Download: ML20062H450 (13) | |
Text
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WN!'ID C'%!.T.*i d_
S'*" "'" '" 3 3 Request for OMB R.e.v.ie..w.s,_
[L, Q1 Cn i A;deoternov 1983) 4 Important R:aa instructions before completing form. Do not use the same SF 83 Send three copies of this form. the material to be reviewed, and for to request botn an Executive Order 12291 review and approval under paperwork-three copies of the supportirg statement, to:
the Paperwork Reduction Act.
i Answer all Questions in Part 1. If this request is for review under E.O.
Office of Information and Regu!atory Af fairs 12291. cornotete Part 11 and $1gn the regulatory certification. If this Office of Management and Budget reauest is for ecotoval under the Paperwork Reduction Act and 5 CFR Attention: Docket Library, Room 3201 1320, skip Part il, compiete Part lil and sgn the paperwo k certification.
Washington, DC 20503 PART l.-Cornplete This Part for All Recuests.
- 1. Deprtment/as;ency and Bureaurottice onginatmg request j 2. Agency cooe U.S. Nuclear Regulatory Commission 3 1 5 0
' J. Name of person wno can best vsner Lestions regaroing tn:s redest Te:epnene nurnter St_ephen McGuire
( 301)492-3757
- 4. Title of mtormmion ecocct o+ or rusen aiung 10 CFR 36, Licenses and Radiation Safety Requirements for Large Irradiators J. Le4dl a' thort!y hr WOrmdL0n cCoeClion Or ruie (Cile United SlJres C0Ce Puo4C law. Cr Otecurwe oraer; 42 mc2201(o)
- 4. Affecteo pt.bhc (C"co al,INr acD*>
5 C Federalagencies or employees i C :naividua.s or t'ouscnows 3 CF3'm ti C Non profit institutions 2 )C State o reca] rwerrrmn 4 E Dusinesses or ot er 'or-ercfit 7 0 SmaH businesses or otranizations
? ART 11.~0cmokte Th!s P rt OMv (f the Recuest is for OMB Review Under Executive Order 12291
- 9. Regu!ation Icent Aer Neb er ANi
. _, _ _ _ ~ _.._ _ _. cr. lurie awened C L T. roe at suanun exn cw ' =xn wryl Type of renew requested C.2 ssatir' anon J! age of deverooment 1 C Stancara U Mato-
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P'oNied c' craf t 2 C Pencing 2 C Nanr ::-or 2 C Fmaiorin'enm hN' mtnenorprooosai
- C Emergency 3 C Fins or intenm trat witncut onor prooosai 4 C Statutory orludicialdeadhne A CT:secton stremea
- "R t O. Coas Inis r=cu!atio i c
- mni ni.wn's er recraveso'na reasirements mat recurre OMB aporovai under the Paoerwor < Pecuction Act a1d 5 CFR 1320?
. C Yes C No
- 11. If a rN!ct rue, o,'Mrg a reg Mc ? mSJct an3Wsis att1c'40?
2 C Yes 2 O No 3 C Yes 4 0 No i!"No ' 6J CMB wave im a: m W Cifttfication TCr r(equiatcry ;,uDmissions In suDmittmg this request ter OMS revew the author' Zed regulatory contact anc the program offic:al certify that the requirements of E.O.12291 and any apphcacie CofiCY directives n.We DMrs Ccn cred wit" Date rgnatu e o prgam oncal
%gr,ature or aancmeo ruumtM cor:A?
I i
,,, i t l Date
- 12. q u Af B use omy) standard form 83 (Rev 9 63) 7<ewoe et ors casetete y tr3 Prescribed by OMB LisN 7520-m 5 R4Mt
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$ CFR 1120 and E o 12291 9012040316 901127 q[O PDR ORG EUSOMB
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PAET ll; -Complete This Part only if the R:ou:st is 1:r Appr;v:1of a C:llecthn of informatern Unrer tnt Prp rwith Reducten Act rnd 5 CFR 1320.
- 13. Arstran-occnneneecs.usesand affecteaaubhein sowerdsoriess " Radiation Safety Radioactive Materials" The proposed 10 CFR 36 would adopt safety requirements for the licensing, reporting and recordkeeping for large gammar irradiators, which are for the most part a codification of current licensing policy and practices.
14.1 yoo of inrarmatten coiiection (cnecx omy one)
Info?mation conectrons net contamed i t rules 13 keguiar submissica 2 ] Emergency submission (cettricarson artacced)
Informa tion colisctbons contamed in rules 3 U Exist ag revulation(no enante prooosed) 6 finai or intenm fina6 without prior NPRM
- 7. Enter date et eroecteo or actual Fcoerai 4 3 Notice of proposed ruiemakirg(NPRM)
A C Regular submission Register pubiitation at tnis stage of ruiemaking 5 U Fu.a;. NPRM vias prevsousiy pubbsted B C Emergency submission (certification ar! ached)
(moith, day. year; 12/90 D hce ct rev ew reouesta tchecn omy one) 13 New conectier.
4 O Reinstateme,i et a prev.ousiv approvec coiiectioiiior *nien approve has eroired J C wevis on of a currently approved conectior, 3 ] E> tension cf the eciration cate of a currently accroved coilection 5 C Ersting collection in use witnout an oMB controi number witnoe :nv enance 'n tne suostance or in tne metnod of conection R ng:ney reost terra numcer(s)(trysuce stancard/ optional form numoer(s))
l 22. Purpose of information conection (checA as many as a000 j
1 O Aephcation for eenefits 2 C Program evaivation
- 17. Armual re;orting or ersoosure Dureen l
3 C Generalpurpose statist:cs 1
4 T Reguiatory or compnance i imoet of iesconcents 1
5 C Program planning or management 2 m.mec et responses cer resconcern 1
6 U Researen 3 Totm annur resocnses (irne 1 trmes ima tr 1
7 C Audit
.i Nu's cer response l
1 l
? TotM nou'unt'e 3 times t ne C IJ. annusi reeorcreeping Durcen
- 23. F requency of recoranceping or reporting (cneca air that apply) 1
- 11) Recordxceping 1 Number of recoroneepers l
l Reporting 2 Annuai nours per recorckeepet 3 To:al recorokeepina nours (Isna 1 times line 2)
I I
l 2 30 onoccasion 4 Hnordkeeoing retention period l
years' 3 g w,,g,y
- 19. lota6 annuai eurcen 4 O Montniy 1 Requestes Orne 17 5 pius one 183) 1 5 0 Quarterly 2 in current oMB inventory G C Semeannually 3 Ditterence (fsne J sess uns 2) 7 O Annvany Exooanatson ot ditterertct 8 0 Bsennially 4 Program change 9 C otrer(cescribe) 5 AcNstment
- 20. current tmest rece-t) oMB controi numeer er commert numoer
- 24. Responcents' obogshon to comply (check the strorgest ochgation tnat appnes) 1 C voluntary
- 21. He Lestec eroiration date 2 O Required to obtain or retain a benefit 3 years from approval 3 5D Mandatory
_25. Ara the resconcents onmanly educational agencies or institutions or is the pnmary purpose of tne coilection related to Feoeral education programs? O yes
- 26. oces the agency use samohng to se'ect respondents or does tne agency recommend or presenbe tne use of sampung or statistical analysis
. O ves @ No ny resooncents?
- 27. H:guratory autnenty for tne information conection 10 cra_ 36
- o, FR
- or,otner (spec;fy)
Paperwork CartlEcation in submitting tnis request for oMB approval, tha agency head, the senior official or an autnonzed representative. certifies that the requirements of 5 CFR 1320. the Pnvacy Act, statistical standaros or directives, and any other appheabie information policy directives have been comphed with.
Date Signature of progeam otticial S gnature of agency neac. tne sa' r otticial or an autnonted reoresentative oate W-
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h 9 7 -10 Patricia G. N rey, DS0 for in~ormation R Vources Manaaement O CPO i 1984 0 - 4$ 3-776 I
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's OMB SUPPORTING STATEMENT FOR 10 CFR 36,
" LICENSES AND RADIATION SAFETY REQUIREMENTS FOR LARGE IRRADIATORS" Description of Information Collection The reporting requirements of 10 CFR 36 would affect 25 NRC licensees.
The licensees would make the required reports available at their place of business or send the reports to the appropr1ste NRC Regional Office (Appendix 0 of 10 CFR 20).
Records retained for inspection onsite include the license applica-tion, training records, emergency procedures, film badge and TLD results, records of radiation surveys, radiation survey meter calibration records, results of leak tests, records of inspection and maintenance, a log book record of malfunctions, operating difficulties, and operating problems, an inventory of all sealed sources, and records of the leak tests of stainless steel pool liners.
Reports are only required as occasioned by the occurrence of specific events such as the theft or loss of radioactive material, events involving over exposures. excessive concentrations or levels of radiation, loss of one day or more of operation of the facility, property damage in excess of,2,000, leaking sources, damaged sources, and pool water contamination.
,40 tu be reported, if not included in the aforamentioned events, are sources stuck in unshielded position, fire or explosion in the radiation room, damage to source racks, abnormal water loss or leakage from the source storage pool, detection of radiation by the product exit portal monitor, abnormal or unusual radioactive contamination, and degradation of the pool liner or walls.
Licensees must also notify individuals of their exposure to radiation or radioactive material.
These recordkeeping and reporting requirements are currently performed by licensees in accordance with the requirements of 10 CFR Parts 19, 20, and 30.
The proposed Part 36 brings together in two specified sections, 636.81 and S36.83, all of the recordkeeping and reporting requirements for licensees of large irradiators, thus providing the licensees a convenient " check list" to make sure all required records are being kept and to ensure reports are submitted as occasions require.
These records and reports are necessary for the NRC to fulfill its responsibility to protect the health and safety of the 1
0 public and to enhance safe operation of the large irradiators by analyzing operational occurrences and data and communicating safety-related improvements and precautions with all licensees.
All reports submitted will be subject to public disclosure upon request.
The only exception is that certain proprietary information (information of commer-cial value, " trade secrets") could be withheld if properly identified by the licensee at the time of submitting the report.
A.
Justification 1.
Need for the Inf ormation Collection The information that will result from the recordkeeping and reports required by the proposed rule should provide timely general operation performance data and information on precursor events that may have safety significance. This infor-mation will be used to monitor the irradiator's operation to ensure safety significant events can be identified for proper corrective action and so that this operational data may be shared with other irradiator facilities to pre-clude their repetitior Trends may also be determined and analyzed to allow preventive action (maintenance) thus ensuring safe operation.
Recordkeeping i
l also provides a history of operation that can be utilized in assessing an abnormal occurrence in order to determine the root cause.
All of the record-keeping activities are currently required by various 10 CFR Chapter 1 regula-tions or by license conditions.
The regulatory objective is to utilize opera-l tional data to promote safe operation of the large irradiators.
Licensees of these facilities are the sole source of operational data.
i The information collection requirements of the proposed 10 CFR 36 are identified below.
636.11.
Application for a soecific license, and 636.13.
Specific Licenses l
l for large irradiators.
Taken together, these two sections require a licence applicant to submit an application on Form NRC 313. The purpose of the application is to permit the NRC to determine whether the applicant's equipment, procedures, and personnel 2
are adequate to protect public health and safety.
Burden will be applied to NRC Form 313, clearance number 3150-0120 at next clearance extension.
636.19 Request for written statements.
This section requires licensees to submit, upon request, any additional information that NRC may need to determine whether or not the license should be modified, suspended, or revoked. The purpose of the section is to allow the NRC to obtain additional information if there is a question about whether public health and safety are being adequately protected.
436.81. Records and retention periods.
l The records that a licensee nust maintain and their retention period are specified in a siigle section.
The records and their retention period are as follows-(a) A copy of the license application and the license authorizing the licensee to operate the facility, until a new license is issued.
The purpose is so that the licensee has a record of the commitments that it has made and that it must comply with, g
(b) Records of individual's training, tests, and safety evaluations provided to meet the requirements of S36.51 (except S36.51(e)) until 3 years after th9 individual terminates as an irradiator operator.
The records al1Jw NRC inspectors to verify that irradiator operators have received the required training.
(c) -Records of the annual evaluations of the safety performance of, irradiator operators required by 636.51(c) for 3 years after the evaluation. The records allow NRC inspectors to verify that the licensee has been evaluating the performance of its operators.
(d) An up-to-date copy of the operating and emergency procedures required by 636.53, and records of all revisions made within the previous 3 years.
The records allow the operators to have access to an up-to-date set of written operating procedures so that they can operate the 3
t irradiator properly. The procedures may be disposed of immediately upon being replaced by a new or revised procedure.
(e) Film badge and T1.D results required by $36.55, until the license is terminated by the Comission. The records allow NRC inspectors to verify that the licensee is complying with the NRC's radiation dose limits. This requirement is a reminder to licensees and is the same astherequirementin$20.401(a)and(c)(1).
Therefore it has the same retention period.
1 (f)
Records of radiation surveys required by 636.57(a) and (b) for 3 years.
The records a'llow NRC inspectors to. verify that required radiation surveys have been done and that radiation dose limits are being complied with.
(g) Records of radiation survey meter calibrations required by S36.57(c) for 3 years from the date of each calibration.
The records allow NRC inspectors to verify that required calibrations have been performed.
L j
(h) Records of the results of leak tests required by S36.59, for 3 years.
The records allow NRC inspectors to verify that required leak tests to detect radioactive contamination have been done.
(i) Records of operational quality assurance checks required by S36.61 l
for 3 years.
The records allow NRC inspectors to verify that the licensee is making necessary safety checks to maintain the irradiator in safe working condition.
(j) Records of malfunctions, defects, operating difficulties or irregularities, and operating problems for 3 years after the problem is corrected.
These records allow NRC inspectors to verify that the irradiator is being properly maintained and repaired.
The records also allow NRC to identify generic problems that may decrease safety.
(k) An inventory of all sealed sources (but not check sources), until the irradiator is decommissioned. The inventory must include for each sealed source:
date received, person from whom received, model of 4
4 g
4 the source, serial number of the source if any, radionuclide in the source, activity of the source in curies at the time of receipt, an up-to-date location of the source, date source was disposed cf if applicable, and the person to whom disposed source was sent if appli-cable. The records allow the NRC and the licensee to account for all radioactive sources and assure that no radioactive sources have es-caped effective control.
(1) Records of the checks of quality assurance in design as required by
$36.39 and in construction as required by S39.41 until the license is terminated.
The quality assurance checks must be signed and dated.
The title or qualification of the person signing must be included.
These records allow the NRC inspector to assure that the irradiator was properly and carefully designed and conrtructed.
(m) Records of water added to the pool as required by S36.1(a)(14) for three years.
The records allow the NRC inspactor to assure that the irradiator pool is not leaking and that an effective barrier is pre-sent to prevent leakage of radioactive contamination from the irradiator.
(n) Records related to decommissioning of the irradiator as required by 630.35(g).
This reference is added for completeness to remind the licensee that another part (Part 30) requires certain records, as specified in Part 30, that are related to decommissioning.
S36.83 Reports (a) The licensee shall notify the Commission of:
(1) the theft or loss of radioactive material as required by S20.402, and (2) events in-volving radioactive material possessed by the licensee that may have caused or threatens to cause radiation overexposures, excessive con-centrations or levels of radiation, loss of one day or more of opera-tion of the facility, or property damage in excess of $2,000 as required by S20.403 or S20.405. This is not a new requirement but is merely a reminder to licensees that they must follow the reporting requirements in S20.403 and S20.405.
5
i (b) The licensee shall notify individuals of their exposure to radiation or radioactive materials as required by S19.13.
This is also not a new requirement but is merely a reminder to licensees that they must meet the reporting requirements in S19.13.
(c) The licensee shall report leaking sources, damaged sources, and pool water contaminated in excess of the concentrations in Table 1, Column 2 of Appendix B of Part 20 in writing to the appropriate NRC Regional Office listed in Appendix 0 of Part 20 of this chapter within 3 days of discovering the contamination.
The report must describe the source involved if known, the extent of the leakage or contamination, the cause of circumstances leading to the leak or contamination to the extent that they are known, and corrective actions taken up to the time the report is made.
The NRC needs reports of leaking radioactive sources to be able to confirm that radioactive contamination has been property cleaned up and to identify whether there are generic problems with certain models of sources.
(d) The licensee shall report within 5 days in writing to the appropriate NRC Regional Office listed in Appendix 0 of Part 20 the following events if not reported under paragraphs (a) or (c) of this section:
(1) Sources stuck in unshielded position.
(2) Fire or explosion in radiation room.
(3) Damage-to source racks.
(4) Failure of the cable used to move the source racks.
(5) Significant major breakdown in access control systems.
(6) Detection of radiation by the product exit portal monitor.
(7) Abnormal or unusual radioactive contamination.
(8) Degradation of the pool liner or walls.
(9) Abnormal water loss or leakage from the source storage pool.
4 The purposes of these reports are to ensure that the licensee has properly corrected a potentially hazardous situation and to determine if any class of irradiators might have generic safety problems that should be corrected.
6
2.
Agency Use of Informat M
=
Analysis of operational data surrounding several safety significant occurrences i
.in the world-wide community of large irradiators has been utilized by the NRC i
to develop the presently used safety criteria and license conditions.
These requirements have precluded a repetition of these events at facilities and have St e
C fice o Nuc r a S fet ad a g ards N S) n tors the operation of the large irradiators in conjunction with regional staff
_j assigned to inspect and monitor these facilities.
Reports containing timely operational data are essential in order to confirm and ensure safe operation.
If the reports indicate the possibility of a continuing hazard at the irradia-tor, the NRC will take action.
In many situations an emergency inspection may be carried out.
Records retained by the licensee are also important and are reviewed during routine and special inspections of these facilities to assure safe operation.
Accordingly, the proposed rule requires reports to be submit-ted to the appropriate NRC Regional office listed in Appendix 0 of 10 CFR Part 20, 3.
Reduction of Burden Throuch Information Technology There are no current information technology applications which would impact (e.g., reduce) the burden of these information collection requirements.
However, the NRC encourages the use of any new technology.
4.
Effort to Identify Duplication The collection of the specified information is not a duplication of other information the affected licensee must submit for other purposes. The nature of the information being requested is unique to NRC's activities at the facilities. The Information Requirements Control Automated System (IRCAS) was searched and no duplication was found, 7
w
5.
Effort to Use Similar Information There is no other information already available that can be used to assess the safe operation of the irradiators or to identify trends and precursors that must be corrected to ensure continued safe operation.
6.
Effort to Reduce Small Business Burden While a number of the licensees are considered small businesses, under the NRC's current definitions, all licensees have the same responsibility for safe operation of their irradiators. Therefore, there is no way to reduce the
' burden on small businesses by less frequent or less complete records or reports while maintaining the required level of safety.
7.
Consecuences of Less Frecuent Collection The proposed 5 day reporting period represents a balance between allowing l
sufficient time to collect, analyze, and write up the necessary information and requiring that the report be submitted before memories of what happened fade. These reporting periods will provide the regulatory analyst information i
in a time frame that is necessary to analyze and react in a timely manner con-sistent with the operation of the irradiator. The reporting period is judged to be sufficiently short so that the licensee's corrective actions may be sup-i plemented when needed to protect the health'and safety of the public and the irradiator employees.
8.
Circumstances Which Justify Variations From OMB Guidelines Any report required in less than 30 days is a variation from OMB Guidelines.
Reports of significant safety problems are required in less than 30 days:
(1) in case emergency actions are necessary to reduce the hazard; (2) in case an i
emergency NRC inspection is necessary to assure the problem is being handled properly;and(3)incasetheproblemisimportantenoughthatother licensees should be promptly informed.
Records that raust be retained longer than 3 years are contained in:
536.81(a); 9 36.81(e); 936.81(k); 936.81(1); and 636.81(n). The justifications are as follows:
8
s
$36.81(a): The license must be kept for as long as it is in effect.
It would be difficult to obey the conditions of a license if there were no written copy.
636.81(e):
This merely restates, as a reminder, an existing Part 20 requirement, i
G36.81( k):
It is important in protecting public health and safety to be able to track the receipt, possession, and disposal of all licensed radioactive sources, t
636.81(1):
As long as the facility is in operation, records of the design and construction of its principal safety features are important in maintaining and demonstrating the safety of the facility.
636.81(n): This merely restates, as a reminder, the existing requirements in530.35(g).
9.
Consultation Outside the NRC Telephone discussions with the Agreement States having the greatest number of
. licensed large irradiators disclosed that the proposed rule would benefit the states from the standpoint of simplifying their effort to assure compatible recordkeeping and reporting requirements in their regulations.
It should be noted the Agreement State licensees report to their states, not directly to the NRC, so there will be no duplication of effort, 10.
Confidentiality of Information Reports submitted generally would be subject to public disclosure :n accordance with 10 CFR 2.790 and 10 CFR Part 9.
Section 2.790 allows the NRC to withhold certainproprietaryinformation(informationofcommercialvalueor" trade secrets") if, at the time of submittal of the report, the requirements for withholding the information are met (refer to 10 CFR 2.790(b)). Also, there 9
4 4
are provisions in 10 Cr'R Part 9 for the NRC to withhold from public disclosure documents such as reports of radiation exposure to individuals and other per-p sonal records.
- 11. Justification of Sensitive Questions No sensitive information is requested under these regulations.
- 12. Estimated Annual Cost to the Federal Government The annual burden on the NRC to review records is estimated to be 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> per licensee per year, or 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> for all_25 licensees. The annual burden to review reports for all licensees is estimated to be an additional 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> per year. The total is 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> per year. At a cost of $92 per hour, the total annual cost to NRC is $36,800 per year.
13.
Estimate of Burden The total burden is estimated to be 750 hours0.00868 days <br />0.208 hours <br />0.00124 weeks <br />2.85375e-4 months <br /> per licensee per year, or a total of 18,750 hours0.00868 days <br />0.208 hours <br />0.00124 weeks <br />2.85375e-4 months <br /> per year for all 25 irradiator licensees. The details are shown in the attached Tables 1 and 2.
- 14. Reasons for Change in Burden A new CFR Part dealing with the large irradiators is being added.
- 15. Publication for Statistical Use There is no application to statistics in the information collected. There is no publication of this information.
10
Table 1.
Reporting Burden of Proposed Part 36.
No. of Annual Responses Annual hours Total burden Section Licensees per licensee per licensee hours Comment or explanation
$36.11 25 0
0 Covered under 536.13. Burden for 536.11 and 536.13 to be incorporated into burden for NRC 313, riearance number 3150-0120.
36.13 25 1
100 2,500
$36.19 25 1
1 25 536.69 25 1
1 25 Assuming 1 report / year from the 25 licensees.
536.83(a) 25 0
0 This is a reminder referring to 20.403.
536.83(b) 25 0
0 This is a reminder referring to 519.13.
536.83(c) 25 1
9 225 536.83(d) 25 1
40 1,000 Total 151 3,775
C Table 2.
Recordkeeping Burden of Proposed Part 36.
[-
No. of Annual hours Total burden Section Recordkeepers per licensee hours Corr:nent or explanation 536.21(b) 25 2
50 936.81(a) 25 1
25 536.81(b) 25 20 500 536.81(c) 25 2
50 536.81(d) 25 40 1,000 536.81(e) 25 20 500 536.81(f) 25 80 2,000 536.81(g) 25 6
150 536.81(h) 25 20 500 536.81(1) 25 200 5,000 536.81(j) 25 20 500 536.81(k) 25 20 500 536.81(1) 25 160 4,000 Averaged over 10 years 536.81(m) 25 8
200 536.81(n) 25 0
0 Covered under 30.35(g)
Total 599 14,975
-