ML20198B238

Request for OMB Review & Supporting Statement Re 10CFR34, Licenses for Radiography & Radiation Safety Requirements for Radiographic Operations. Estimated Respondent Burden Is 54,482 H

ML20198B238
Person / Time
Issue date:	05/15/1986
From:	Norry P NRC OFFICE OF ADMINISTRATION (ADM)
To:
References
OMB-3150-0007, OMB-3150-7, NUDOCS 8605210577
Download: ML20198B238 (11)

Text

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/M mem e=w sooard re,m s3 #

tue , sept,rnner iwh Request for OMB ReviewC n111od Ly e,w# [LM .

important Read instructions before corople ting form. Do not use the same SF 83 Send three copies of this form, the material to be reviewed, and for to request both an E secutive Order 12291 review and approval under paperwork -three copies of the supporting statement, to-the Paperwork Redortion Att Answer all questions in Part t If this request is for review under E O Of fice of information and Regulatory Af fairs

]2291. complete Part li and sigri the regulatory certif. cation if this Othce of Management and Budget riquest is for approval under the Paperwork Reduction Act and 5 CFR Attention. Docket Library. Room 3201 1320. sbp Part 11, complete Part til and sign the paperwork certification Washington, DC 20503 PART l.-Complete This Part for All Requests.

I'. Department / agent y and Hureau%f'tice origmating request . Agency code U.S. Nuclear Regulatory Comission

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Dame of person who tan t est answer questions regarding ttm request Telephone number John Hickey <301 1 427-4093

4. Title of intofn ation cofie(tion or rulemanirig 10 CFR 34, Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations S. t evI authorsty for informat,on <oflert on or ruIe (nte Unoted Swes Code. Puta.c ias. cr E uecwwe Order) 42 usc 2201(o)

6. A'te< ted public (che(4 all that amy) $ C Federa agencies s or errployees 1 C Ind*vuluais or households 3 C farms 6 C hon prof.t institutions 2 C 51ateor localgovernments 4 [3 8 ninessm er other tnt prctt 7 (( Small busine%es or organi/ations PART ll.-Complete This Part Only if the Request is for OMB, Review Under Executive Order 12291

7. Rryulation identier Number (RIN)

- . _ _ ~ _ _ _ _ . Or, Nor+ awFred U ,

Dype of subminnon (cheTione rn esch cate r'acy) Type of review requested Ct:sstlicatters Stage or development g Q 5tancarc 1 C Ma;or 1 C Prcored or oratt 2 Pendir g 2 C None-a,or 2 C r u e, nt-,,m e.nai. ~en or.o, nn re.ai 3 C tme,sency 3 C Finat or **erun toaf, ethout prior propM 4 C Statuto'y or gudioaldeadline

9. Cf H set tron attecte<1 l .-...- _ CFR . _ . .

10. Does the regulit,on (onta n reporting or record.eco,n,t te we+ects that recuae OMO approvat unrier the pacerwori Recuction Act i and $ CF R 1320? C ye, "] Ne l ll. it a vname rute. n there a rcrulatory imr..ct anaws att w h@ l U Yes 2 U No it No " did OYH *av the an ps 3 3 U ves 4 U.No Cartificction for Regulatory submissions r

in sut.m.tt.ry th6 reunest for OMB rev.ew, the autnonfed rewo'ory conut and the ervam o f.nal < ertity that the requerernents of E O 12291 and ant apstatue poht y direc twes have rcen r omplied w.th Wature of pergam o rf.oa Date j

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PART'llt.~-Complet)This Part Only if the Request is for Approvilaf a C:ll:cti:n of Information Under the Paperwork Reduction Act and 5 CFR 1320.

13. Abstract-Describe needs, uses and affected pubirc in 50 words or less

" Radioactive materials, radiation safety" 10 CFR 34 establishes rules governing the domestic licensing of byproduct material for use in industrial radiography. ,

!4. Type of mformatico collection (chech only one)

Information collections not contained in rules 1 I Regular submission 2 O Ernergency submission (certaticat,onattached)

Llormation collections contained in rules 3 3 Esistmg regulation (no change proposed) 6 Fmat or interim final without pnor NPRM 7 Enter date of espected or actual Federal 4 Notice of proposed rulernaking(NPRM) A E Regularsubmission Heester pubhcation at this stage of rulemaking 5 0 Final. NPRM was previously pubhshed B O Emersency submission (cert r, cat,on attached) (month. d>r > ear >.

15. Typs of reviea requested (chec& only one) 1 O New collection 4 0 Re nstatement of a previeusiy approved coiiection for wnicn approvai 2 O Revision of a currentty approved coiiection " "

• 3 @ Estension of the empiration date of a currently approved collection 5 0 Existing ccitection in use wthout an oMB control number without ariy change m the substance or m the method of collection

16. Agency report form number (s)(mclude standardioptional form number (s)) 22. Parpose of information collect,on (chech as many as apply)

None 1 C ^P P"#d " ' ' b'"

2 O eregram evaivat on

17. Annual reportmg or disclosure burden 3 O Generalpurpose statistics 1 Humber of respondents . .

4 h Regulatory or comphance 0 b S O PrWram plar rong or ma iger ent 2 Number of responses per respondent .

3 Total annua' responses (hne J times hoe 2) 6 0 Research 4 Huurs per response .

Varles 7 O Audit 5 Tot.sf hours (lme 3 tomes ime 4)

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18. Annuit recordheepmg burden 23. Frequency of recordheepug ar reporting (check allthatap)/y) 1 Number of recordbeepers I h Recordheepir:g O b Reporfing 2 Annual hours per recordkeeper.

3 Total recordkeeping hours (hne j t,mes hne 2) 5 7 g on ,cc,,,,,

4 Recordheepmg retention penod 3 years 3 0 weeuy

19. Total annual burden 4 O Morithly 54,482 1 Requested trene 17 $ plus kne 18 3) .

_ 54,482 5 0 Quarterti 2 in current oMB mventory 6 0 semr annuany 3 Difference (tme i less hne 2) 7 O Annvany laplanation of difference 8 O FLenn,ahy 4 Pengram change _

9 $ other(describe)Rene m LapAlication_fsry 5 year 5 Adgment

20. Current (m en control number or comment number 24. Respondents' obt'gatior' to rompiv (chec A the strongest obligation thJtapphes) 1 O Voluntary

21. Requested empiration date p j Required to otitain ce retain a benef.t 3 years from appoval date 3 j y y ma,n, ___

25. Are tbc responder'ts primarity educational agenoes or institutions or is the pr,mory purpose of the ccitec tion related to redr. rat education programs? Yes Q No

26. Does the agent $ use samphng to select revondents or does the agency recommend or presenbe the use of sampart or statrstical analysis Yes 3 No by respondents .

2 7. Hegulator thority for he mtormation conection CFR 4  ; or FH . or. Gtr ec ovecity) _

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P5&Tri Cir66csiion In sutmttrg tha request for oMB approval, the agency head. the semor off oal or an authorged res eser'tative wt r'es that tt e requirements of 5 CFR 1320. the Privac y Act stat.5tical standards or directives, and any other appl. catsi e mformaton pot.c y ditectives have twem omphed wM

$f f'Jture ofPTfrain n et4 at Date

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Qnatuer of agency head the senior of'. oat or an authoracd representative ~Date Patricia G. Norry, Director Office of Administration d> b /

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i SUPPORTING STATEMENT FOR 10 CFR PART 34 LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS Justification Need for and Practical Utility of the Information 10 CFR Part 34 provides certain requirements exclusive to licensees using byproduct material for purposes of industrial radiography, a technique of non-destructive testing. The byproduct material is normally employed in the form of sealed sources which emit high levels of radiation. Those sources are remotely moved from their shielded position in the radiographic device to an unshielded position up to about 15 feet away and again returned to their shielded position during each radiograph. These radiographic devices are also often moved from location to location at a job site, and further transported from job site to job site. The many manipulations of the sources and movement and transport of the devices result in unique and continuing potential and actual hazarjous radiological conditions.

Section 34.3 requires that applications for specific licenses for use of sealed sources in radiography be filed on NRC Fonn 313, " Application for Material License." Form 313 bas been previously cleared under OMB No.

3150-0120, which should be referred to for further supporting information, burden and cost data.

_Section 34.11(b) required applicants to hwe a training program for radio-graphers and radiographers' assistants, and to submit to the Commission a schedule or description of the program specifying (1) the initial training; (2)-periodic training; (3) on the job training; (4) means to be used to detennine the radiographer's knowledge and understanding of and ability to comply with Commission regulations and licensing requirements, and the

operating and emergency procedures of the applicant; and (5) means to be used to determine the radiographer's assistant's knowledge and urderstanding of and ability to comply with the operating and emergency procedures of the l

applicant. This information is reviewed by the NRC staff to ensure that radiographers and their assistants will have sufficient training to enable them to work safely and in compliance with NRC regulations, license conditions, and licensee operating and emergency procedures.

The burden and cost associated with this requirement are incurred in connection with the submission of the application, NRC Form 313, referred to under Section 34.3 above, and will therefor be reported under the clearance for that fonn, OMB No. 3150-0120, which should be referred to for information collection burden and supporting data.

t Section 34.11(c) requires that applicants establish and submit to the Commission satisfactory written operating and emergency procedures. The operating and emergency procedures are intended to provide radiography personnel with step-by-step instructions and procedures so that the performance of industrial radiography will not endanger health or pose a danger to life or property. The preparation of operating and emergency l

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- l i procedures is intended to assure that radiography personnel are aware of )

specifically what needs to be done and how it shall be done, so that there is no misunderstanding of what is required of eachperson involved in the overall radiography operation. The NRC reviews the operating and emergency procedures to ensure that they are complete, clearly written, unambiguous, and germane to the applicant's proposed program for use of sealed sources and exposure devices for the performance of industrial ragiography.

The. burden and cost associated with this requirement are incurred in connection with the submission of the application, NRC Fom 313, referred to under Section 34.3 above, and will therefor be reported under the clearance for that form, OMB No. 3150-0120, which should be referred to for information collection burden and supporting data.

Section 34.11(d) requires licensees to conduct internal inspections / audits of the perfomance of radiographers and radiographer's assistants at -

intervals not to exceed three months and to retain records of such

! inspections / audits for two years. NRC's planned record retention rulemaking will amend this section to require the retention of these records for three years. A proposed revision to Section 34.11(d) will add a requirement that ifcensees submit a description of their procedures for inspecting the perfomance of each radiographer and radiographer's assistant. The i purpose of the inspections / audits is to make management assure itself that personnel are working safely and as required by NRC regulations, license conditions, and licensee operating and emergency procedures. The records of the inspections / audits will be used by the licensee to keep track of deficiencies, if noted, so that they can be corrected. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC staff during inspections to detemine whether or not possession and use of the licensed material has been in accordance with NRC l

regulations and license conditions.

l The burden and cost associated with this requirement are incurred in

, connection with the submission of the application, NRC Fom 313, referred i

to under Section 34.3 above, and will therefor be reported under the clearance for that fom, OMB No. 3150-0120, which should be referred to for

infomation collection burden and supporting data.

! Section 34.11(e) requires an applicant to submit a description of its

overall organizational structure pertaining to the radiography program,

including specified delegations of authority and responsibility for

! operation of the program. The NRC staff will review this information in order to ensure that the licensee's organization will provide adequate management oversight, supervision and accountability for safe operation of i the radiography program and that the lines of authority and responsibility

are clear and unambiguous.

l The burden and cost associated with this requirement are incure ad in connection with the submission of the application, NRC Form 313, referred to under Section 34.3 above, and will therefor be reported under the clearance for that fom, OMB No. 3150-0120, which should be referred to for infomation collection burden and supporting data.

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Section 34.11(f) requires an applicant that desires to conduct its own leak tests to determine possible leakage or contamination from sources used in industrial radiography to provide its specific procedures for perfoming the tests. The procedures for perfoming the tests must specify the method of perfoming the leak test, the instrumentation to be used for measurement of the leak test sample, and the experience of the person who will perfom the tests. The NRC staff reviews the procedures to ensure that the method of obtaining the leak test sample will be adequate to detemine if there is any leakage or contamination from the sealed source, that the instru-mentation which will be used for measurement is capable of making a cuanti-tative determination of any leakage or contamination, and that the person who will perform the leak tests has training and experience in perfoming such tests.

The burden and cost associated with this requirement are incurred in connection with the submission of the application, NRC Form 313, referred to under Section 34.3 above, and will therefor be reported under the clearance for that fom, OMB No. 3150-0120, which should be referred to for information collection burden and supporting data.

Section 34.24 requires that the licensee maintain sufficient calibrated and operational radiation survey instruments to make physical radiation surveys as required by 10 CFR Parts 34 and 20. It further reouires that each radiation survey instrument be calibrated at intervals not to exceed three months and after each instrument seWicing and that a record shall be maintained of the results of each instrument calibration and the date thereof for two years after the date of calibration. NRC's planned record retention rulemaking will amend this section to require retention of these records for three years instead of two years. The making of radiation suWeys is one of the most important aspects of radiation safety and the instruments must provide reasonable accuracy in the measurement of the levels of radiation to which individuals are exposed during conduct of radiographic operations. The licensee will use the records to assure itself that calibrated instruments are always available to radiographers and radiographer's assistants. The regulations require that the records be retained for the prescribed portod so that they may be reviewed by NRC staff during periodic inspections to ascertain the instrument calibration history and to determine the extent of compliance with this important aspect of radiation safety.

Section 34.25(c) requires a record of the results of the leak tests of sealed sources required by Section 34.25(b) to be maintained for six months after the next required leak test is performed or until transfer or disposal of the sealed source. NRC's planned record retention rulemaking will amend this section to require that these records be retained for three years, in order to confom to a new uniform system of record retention periods.

A leak test is the only effective method of detemining the integrity of the sealed sources. Serious radiological hazards could result from a leaking source. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC staff durino periodic inspections to aid in determining the extent of compliance by the licensee.

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- 4-Section 34.25(d) requires that licensees report within five days of the leak testing any result which would indicate that a source is leaking. The  :

report must describe the equipment involved, the test results, and the  !

corrective action taken. The NRC Inspection and Enforcement staff uses the report in assessing whether the corrective actions initiated by the licensee are adequate to protect workers and the public from the hazards of a leaking source.' The NRC licensing staff uses the report to identify generic problems with regard to source design, radiographic equipment design, or problems in source manufacturing and quality control.

Section 34.26 requires that the licensee conduct a quarterly physical inventory of sealed sources received and possessed under a license and maintain records of the inventories for two years from the date of the

- inventory. NRC's planned record retention rulemaking will amend this section to require that these records be retained for three years instead of two years, in order to conform to a new unifom system of record reten-tion periods. The inventories are used by the licensee to maintain control of the location of the sources, and to control the type, quantity and use of byproduct material within the limits authorized by the license. The regulations require that the inventory records be retained for the pre- '

scribed period so that they may be reviewed by NRC staff to detemine the extent of compliance with authorized possession limits.

Section 34.27 requires that each licensee maintain current utilization ,

logs, which must be kept available for two years from the date of the '

recorded event, at the address specified in the license, showing for each sealed source the following infomation: (a) a description (or make and model) of the radiographic exposure device or storage container in which the sealed source is located; (b) the identity of the radiographer to whom assigned; and (c) the plant or site where used and dates of use. The regulations require that the records be retained for the prescribed period so that they may be used by NRC inspection staff to assist in detemining whether the licensed material has been properly controlled and used. The records are also used by the licensee to maintain control of the licensed material . NRC's planned record retention rulemaking will amend this section to require that these records be retained for three years instead 1 of two years, in order to confom to a new unifom system of record reten-tion periods.

I i Section 34.28(b) requires that the licensee conduct a program for inspection and maintenance of radiographic exposure devices, storage containers and source changers at intervals not to exceed three months and maintain records of those inspections for two years. NisC's planned record retention rule-making will amend this section to require that these records be retained for three years instead of two years, in order to conform to a new uniform  !

7 I system of record retention periods. Periodic inspections and properly 1 maintained equipment are important to the safe conduct of radiography. The

records assist the ifcensee in keeping track of when the equipment was last i

inspected and maintained and when it is next due. The regulations require  ;

l that the records be retained for the prescribed period so that they may be j used by NRC staff to determine the extent of compliance by the licensee, [

< and to detect problems that may be generic to the equipment so that correc- i tive action might be taken.

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Section 34.29(c) requires that the alams on permanent radiographic installations required by Section 34.29(b) be tested at intervals not to exceed three months or prior to the first use thereaf ter of the source in the installation and maintain records of tests for two years. NRC's planned record retention rulemaking will amend this section to require that these records be retained for three years instead of two years, in order to conform to a new uniform system of record retention periods. These alarms are an important backup to the radiation survey instrument and are intended to prevent inadvertent entry into a radiographic installation (cell) while a source is in the unshielded position. The records are used by the licensee to keep track of when the tests were last performed and when they are next due. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC inspectors to detemine compliance with required testing of important safety equipment.

Section 34.31(c) requires that records of training for radiographers and radiographer's assistants be maintained for three years. Specific training rdquirements have been established because of the radiation hazards associated with radiographic operations. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC staff to determine whether the training has been adequate and is in accordance with the requirements of the regulations and license conditions.

Section 34.33(b) and (e). Section 34.3(b) requires licensees to make daily records of pocket dosimeter readings. Section 34.33(e) requires that records of daily pocket dosimeter readings shall be kept for two years.

Reports received from film badge or TLD processors are to be kept for inspection until the Commission authorizes their disposal. NRC's planned record retention rulemaking will amend this section to require that these records of daily pocket dosimeter readings be retained for three years instead of two years, and that reports from film badge or TLD processors be retained until the Commission terminates the license, in or(er to conform to a new unifom system of record retention periods. The records are an important mechanism for controlling exposure to radiation on a day to day basis. They also provide indications of inadvertent exposure or a possible unusual event. In addition, they provide a backup record of estimated exposure in the event that a film badge or thermoluminescent dosimeter is lost. The regulations require that the records be retained for the pre-scribed period 50 that they may be reviewed by NRC inspectors to determine licensee compliance with regulations and to detemine the effectiveness of the licensee's exposure control program.

Section 34.43(c) requires that a record of a radiation survey be maintained for two years when that survey is the last survey to determine if the source is fully shielded prior to locking the exposure device and ending direct surveillance of the operation. At this time the exposure device is normally being prepared for storage or transport and it is very important that the source be fully shielded. A radiation survey is the most reliable and practical method to make this detemination. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC inspection staff to determine the extent of compliance with safety reouierments by the licensee. A forthcomina revision to Section 34.43 would require, in Section 34.43(d), that licensees maintain a record of a time-of-storage survey for three years af ter the survey. The three year record retention period will conform to the new unifom record retention periods being developed.

Section 34.51 requires an application from any licensee who wishes an exemption from the requirements of regulations contained in 10 CFR Part 34.

Upon receipt of the application, the NRC may grant an exemption from any particular part of the regulation if it is determined that the exemption is authorized by law and will not result in undue hazard to life and property.

Use of Improved Information Management Technolooy There is no legal impediment to the use of improved infomation management technology by licensees and applicants.

Efforts to Avoid Duplication The Federal Infomation Locator System was searched to detemine NRC and other Federal agency duplication. No duplication was found.

Efforts to Minimize Burden for Small Businesses Many NRC radiography licensees are small businesses. Efforts have been made to keep the requirements for infomation to a minimum. However, since the consequences of mishandling of a radiography source are likely to be the same for large and small entities, it is not possible to further reduce the burden on small businesses by less frequent or less complete recordkeeping or reporting.

Consecuences of Less Frequent Collection Applications are only required to be submitted for the initial license, for amendments, and for renewal every five years. The application process requires that applicants and licensees perform a comprehensive review of their entire radiation safety program to assure that all activities will be or are being conducted safely and in accordance with NRC regulations. The '

review and submission of the infomation required for the application is essential to NRC's determination of whether the applicant has training, experience, equipment, facilities and procedures for the use of byproduct material that are adequate to protect the public health and safety. Other reporting and recordkeeping requirements are occasioned by specified events such as leak tests, instrument calibrations, and inventories of licensed material . Conduct of these tests and other events and collection of infomation concerning them at the required frequency is essential to the assurance of protection of the health and safety of workers and the public.

Circumstances Which Justify Variation from OMR Guidelines Section 34.25(d) varies from OMB guidelines in requiring that licensees report within five days of the leak testing any result which would indicate that a source is leaking. This requirement for a report in less than 30 i

days is necessary because a leaking source could present a radiological hazard to workers and the public, and NRC must be notified promptly in order to be able to assess whether corrective actions initiated by the licensee are adequate.

Consultations Outside the Agency There have been no consultations outside the agency since the previous clearance of this infomation collection requiremer t.

Assurance of Confidentiality None, except for proprietery information.

Sensitive Questions None.

Publication for Statistical Use None.

Estimate of Compliance Burden Reporting Requirements No. of Licensee Staff Hours Total Annual Section Responses Annually Per Submittal Licensee Burden (Hrs) 34.3 - See OMB Clearance No. 3150-0120 34.11(b) - See OMB Clearance No. 3150-0120 34.11(c) - See OMB Clearance No. 3150-0120 Proposed 34.11(d) - See OMB Clearance No. 3150-0120 34.11( e) - See OMB Clearance No. 3150-0120 34.11( f) - See OMB Clearance No. 3150-0120 34.25(d) 10 0.5 5 34.51 1 2 2 Total 11 , 7 Recordkeeping Recuirements Current Planned Total Record Record No. of Annual Hours per Recordkeeping Retention Retention Recordkeepers Recordkeeper Hours Period Period 34.11(d) - See OMB Clearance No. 3150-0120 2 yrs 3 yrs 34.24 400 2 800 2 yrs 3 yrs 34.25(c) 400 2 800 6 mos 3 yrs 34.26 400 1 400 2 yrs 3 yrs 34.27 400 5 2,000 2 yrs 3 yrs 34.28(b) 400 5 2,000 2 yrs 3 yrs 34.29(c) 150 0.5 75 2 yrs 3 yrs 34.31(c) 400 1 400 3 yrs 3 yrs 34.33(b) & (e) 400 80 32,000 2 yrs 3 yrs 34.43(c),(d) 400 40 16,000 2 yrs 3 yrs Total Number of Recordkeepers 400 Total Recordkeepina Hours Annually 54,475

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. .a Estimated Cost to Public to Respond Section Annual Cost to Resoond 34.3 - See OMB Clearance No. 3150-0120 34.11(b) - See OMB Clearance No. 3150-0120 34.11(c) - See OMB Clearance No. 3150-0120 34.11(d) - See OMB Clearance No. 3150-0120 34.11(e) - See OMB Clearance No. 3150-0120 34.11(f) . - See OMB Clearance No. 3150-0120 34.24 $48,000 34.25(c) 48,000 34.25(d) 300 34.26 24.000 34.27 120,000 34.28(b) 120,000 34.29(c) 4.500 34.31(c) 24,000 34.33(b) & (el 1,920,000 34.43(c),(d) 960,000 34.51 120 TOTAL $3,268,920 Source of Burden and Cost Data and Method of Estimating Data This data is based on previous infomal consultations by the staff with a small number of typical licensees and on the number of submittals to NRC in past years. Cost to licensees and applicants is calculated at a rate of

$60 per hour.

Estimated Annual Cost to the Federal Government The estimated annual cost of professional staff effort for activities other than application review is $180,000 (3,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> 0 $60/hr). Application review and other administrative and clerical activities are attributable to and reported under the clearance for NRC Fom 313, OMB No. 3150-0120, which should be referred to for additional burden and cost information.