ML20013H342

Notice of Pending NRC Action to Submit Info Collection Request to OMB & Solicitation of Public Comment on 10CFR34, Licenses for Radiography & Radiation Safety Requirements for Radiographic Operations. W/Supporting Statement

ML20013H342
Person / Time
Issue date:	04/15/1998
From:	Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0007, OMB-3150-7, NUDOCS 9804170294
Download: ML20013H342 (23)

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[7590-01-P)

U. S. NUCLEAR REGULATORY COMMISSION r

. Agency Information Collectioa Activities: Proposed Collection; Comment request AGENCY:

U. S. Nuclear Regulatory Commission (NRC) i Notice of pending NRC action to submit an information collection request to OMB ACTION:

t and solicitation of public comment.

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i The NRC is preparing a submittal to OMB for review of continued approval of

SUMMARY

information collections under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

l Infomistion pertaining to the requisement to be submitted:

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The title of the information collection:

10 LFR Part 34 - Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations 2.

Current OMB approval number: 3150-0007 i

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9904170294 990415

'CF SUBJ L-4-3 PT3418 EPI CF J

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3 How often the collection is required: Applications for new licenses and ar.undments may be submitted at any time. Applications for renewal are 1

submitted every 10 years. Reports are : 1mitted as events occur.

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Who is required or asked to report: Applicants for and holders of specific I

licenses authorizing the use of licensed radioactive material for radiography.

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The number of annual responses: 73 from NRC licensees and 146 from Agreement State licensees.

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The number of hours needed annually to complete the requirement or request: Ucersee reporting of 106.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> and 213 hours0.00247 days <br />0.0592 hours <br />3.521825e-4 weeks <br />8.10465e-5 months <br /> for Agreement States (approdnately 1.46 hours5.324074e-4 days <br />0.0128 hours <br />7.60582e-5 weeks <br />1.7503e-5 months <br /> per response), for a total reporting burden i

of 319.6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />. Licensee recordkeeping of 60,178.8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> and 120,570 hours0.0066 days <br />0.158 hours <br />9.424603e-4 weeks <br />2.16885e-4 months <br /> for Agreement O3tes (approximately 380 hours0.0044 days <br />0.106 hours <br />6.283069e-4 weeks <br />1.4459e-4 months <br /> per licensee), for a t

total.?cordkeeping burden of 180,748.8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />. The industry total burden is f

i 60,285.3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> annually for NRC licensees and 120,783 hours0.00906 days <br />0.218 hours <br />0.00129 weeks <br />2.979315e-4 months <br /> annually for Agreeme.nt State licensees.

7, Abstract: NRC regulations in 10 CFR Part 34 establish radiation safety l

I requirements for the use of radioactive materialin industrial radiography.

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The information in the applications, reports and records is used by the NRC-i staff to ensure that the health and safety of the public is catected and that

~ licensee possession and use of source and byproduct material is la

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compliance with license and regulatory requirements.

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Submit, by (insert date 60 days after publication in the Federal Reaister), comments that address the following questions:

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Is the proposed collection of information necessary for the NRC to properly j

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perfc m its functions? Does the information hr.ve practical utility?

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Is the burden estimate accurate?

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Is there a way to enhance the quality, utility, and clarity of the information to be collected?

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How can the burden of the information collection be minimized, including the 1

use of automated collection techniques or other forms of information I

i technology?

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A copy of the draft supporting statement may be viewed free of ens ge at the NRC Public j

Document Room, 2120 L Street, NW (lower level), Washington, DC. OMB clearance requests j

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are available at the NRC worldwide web site (http://www.nrc. gov) under the FedWorld collection link on the home page tool bar. The document will be available on the NRC home page site for 60 days after the signature date of this notice.

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! i Comments and questions about the information collection requirements may be directed to the r

NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-6 F33,

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' Washington, DC,20555-0001, or by telephone at 301-415-7233, or by Intemet electronic mail at i:

. BJS1@NRC. GOV.

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--_ 1998.

Dated at Rockville, Maryland, this /E

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For the Nuclear Regulatory Commission.

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ken'dayo. Sheltgrf(NRCflearance Officer j

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.O SUPPORTING STATEMENT FOR 10 CFR PART 34 LICENSES FOP. RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERAYlONS (3150-0007)

REVISION Description of the Information Collection NRC regulations in 10 CFR Part 34 establish rules that specify radiation safety requirements for the use of licensed byproduct material in industrial radiography. The regulations provide for comprehensive ard consistent radiation safety requirements in NRC and Agreement State regulations, and safety requirements designed to reduce the likelihood of accidents involving radioactive sources in industrial radiography.

A.

Justification 1.

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 for the purpose of examining structures and various materials. The sources are remotely moved from their shielded position in the radiographic device to an unshielded position up to several meters away from the device and again returned to their shielded position at the completion of each radiograph. These radiographic devices are also often moved from location to location at a jobsite and also transported from jobsite to jobsite. The many manipulations of the sources and i

movement and transport nf the cievices result in unique and continuing potential and actual hazardous radiological conditions.

Section 3411 requires that applications for specific licenses for use of sealed sources in radiography be filed on NRC Form 313, " Application for Material License." The NRC materials licensing staff will review the information submitted on NRC Form 313 to determine whether an appi;cint for a license has training, experience, equipment, facilities, and procedures for the use of licensed material that are adequate to protect the public health and safety.

The use of NRC Form 313 has been previously approved by OMB under clearance number 3150-0120, which should be referred to for information collection burden and supporting data.

Section 34.13 provides that an applicant must submit the following information with the application:

34.13(b) - Schedule and description of training prograne for racSographers and radiographers' assistants that meet the.equiremet.'.s of @ 34.43; 34.13(c) - Procedures to verify and document the certification s'atus of the k"I [ /

t' radiographers it employs, including that the certificatiori s valid; i

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34.13(d) - Written operating and emergency procedures as described in S 34.45 covering its radiation safety program; 34.13(e) - Program for semi-annualinspections of the job performance of each radiographer and radiographer's assistant as described in 6 34.43; 34.13(f)

- Description of overall organizational structure as it applies to radiation safety responsibilities in radiography, including specified delegations of i

responsibility and authority; 34.13(g) - Identification and listing of the qualifications of the individual designated as the Radiation Safety Officer (RSO), responsible for implementing the licensee's radiation safety program, es described in S 34.42; l

34.13(h) - For applicants that intend to perform leak testing of sealed sources or exposure devices containing DU shielding, a description of procedures for performing the tests and the qualifications of the person (s) authorized to do the leak testing; also, if the applicant intends to analyze its own leak test wipe samples, e description of the procedures to be followed; 34.13.(l) - If the applicant intends to perform their own calibrations, a description of calibration procedures for survey instruments, based on 9 34.25, and a description of relevant experience of the person (s) who will perform the dibratiom, 34.13(j)-

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intifh N n of locations of and a description of all field stations and i

permaner,, Wgraphic installations. This requirement has previously been included under " Facilities and Equipment," ! tem 9, on NRC Form 313; 34.13(k) - Specification of location where all documents and records required by this part and other parts of this chapter will be maintained as specified in 6 34.89; 1

34.41(c) - For applicants that intend to conduct lay barge, offshore platform, or i

underwater radiography, procedures describing activities to be performed.

This information is reviewed by the NRC staff to determine whether the training, radiation safety, and intemal inspection programs and procedures and the licensee's organizational structure will provide adequate protection of the public health and safety. The NRC review ar;d the findings i

therefrom form the basis for NRC licensing decisions.

1 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 34.11 above. The use of NRC Form 313 has been previcasty approved by OMB under clearance number 3150-0120, which should be ref 3rred to for information collection burden and supporting data.

Section 34?.0(b)(1) requires that each radiographic exposum device have an attached label

. bearing information identifying the radionuclide in the device, its activ ty and the date the activity was last measured, the manufacturer, serial, and model number, and the licensee's neme, address, and tefephcae number. This information will serve as a safety notice to users and members of the public. The label requh ement has been incorporated in the regulations, in part, 4 mnformance with ANSI Standard N432.

. jbetion 34.25(b) requires that each radiation survey instrument be calibrated at intervais not to uceed six months and after each instrument servicing, and Section 34.25(c) requires that a l

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record of the calibration be maintained in accordance with @ 34.65. The radiation survey is one of the most important acpects of raoiation safety and the instruments must be periodically calibrated to assure reasonable accuracy when measuring radiation levels that individuals are axposed to during radiographic operations. The licensee will use the records to assure itself that the instruments available to radiographers and radiographer's assistants are properly calibrated.

The records allow NRC inspectors to verify that required calibrations have been performed.

Section 34.27(c)(1) requires that a licensee who uses sealed sources to have the source tested for leakage at intervals not to exceed six months, andj.ection 34.27'c.)G) requires the licensee to maintain records of leak test results of sealed sources in accordance with @ 34.67 A leak test is the only effective method of determining the integrity of the sealed sources. Serious radiological hazards could result from a leaking source. The records allow NRC inspectors to verify that required leak tests have been performed.

Section 34.27M) requires that licensees report within five days results of leak testing which i

indicate that a source is leaking. The report must describe the equipment involved, the test results, and the corrective action taken. The NRC 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 staff also uses the report to identify generic problems with regard to source design, radiographic equipment design, or problems in source manufacturing and quality control.

Section 34.27(e) requires leak testing of the 'S" tubes of those radiographic devices that use depleted uranium (DU) for shielding at least annually and maintain records of these tests in accordance with @ 34.67. These records allow the licensee and the NRC to verify that the required tests have been performed to verify the condition of the "S" tube.

Section 34.29(a) and (b) require that the licensee conduct a quarterly physical inventory to account for all sealed sources, and all devices containing DU, received and possessed under the license and maintain records of the inventories under @ 34.69 for three years from the date of the inventory. This information is used by the licensee and NRC to verify that all radioactive materialis accounted for and is properly stored.

Section 34.31(a) and (b)(1) and (2) require that the licensee have a program for inspection and maintenance of radiography devices, source changers, associated equipment, transport and storage containers, and survey instruments, and for inspection and maintenance of Type B packaging used to transport radioactive raaterials. Sevien 34.31(c) requires the license make a record of any equipment problems and any maintenance performed during the dai'y visual and operability checks specified in @ 34.31(a), cr during the inspections specified in @ 34.31(b), and specifies that these records must be made in accordance with @ 34.73 and each record retained l

for 3 years after it was made. The records are needed for the licensee and NRC to verify that appropriate actions have been taken if problems are found and to assist ths licensee in keeping track of when the equipmerd was last inspected snd maintained ar.d when the inspection is next i

due. The records are used by NRC staff to determine the extent of heensee compliance.

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Section 34.33(b) requires that entrance controls and/or the visible ud audible alarms on permanent radiographic installations required by Section 34.33(a) tse tested and records of the

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4 tests maintained. Entrance controls are to be tested monthly while both visible and audible alarms must be tested at the beginning of each day the installatior' is to be used in order to ensure that they are functioning properly to prevent inadver%nt entry into a radiographic installation (cell) while a source is in the unshielded position. Records of the alarm tests and entrance control tests are to be maintained under S 34.75 for three years amer it is made, These alarms are an important backup to the radiation survey instrument and are intended to prevent inadvertent entry Liu a radiographic installation (cell) while a source is in the unshieldcd position. These records are used by NRC to ensure compliance with its regulations regarding worker and public health and safety.

Section 34.35(a) requires that the licensee not use a source changer or container to store licensed material unless the source changer or the container has securely attached to it a durab'e, legible, and clearly visible labei. This requirement ensures that any individual who may come in contact with the source changer or sinrage container is made aware o' the presence of radioactive material.

34.35(b)(2) requires that the licensee not transport licensed material unfass the material is packaged, labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in 10 CFR Part 71. This is necessary so that the licensee may demonstrate that it is in compliance with regulation stated in Parts 34 and 71.

Section 34.43(b)(1) requires the licensee to provide radiographers with copies of pertinent sections of Parts 19,20,30, and 34, as well as instructions in applicable Department of Transportation regulations as referenced in 10 CFR Part 71, the NRC license, and the licensee's operating and emergency procedures. These are needed to ensure that radiographers are sufficiently k'owledgeable of applicable regulations prior to using licensed material Section 34.43(c)(1) requires the licensee to provide radiographers' assistants with copies of pertinent sections of Parts 19,20, and 30, and instructions in applicable Department of Transportation regulations as referenced in 10 CFR Part 71, and the NRC license under which the Essistant will perform iadiography, as well as copies of the licensee's operating and emergency procedures.

This is needed to ensure that radiographers' assistants are sufficiently knowledgeable of applicable regulations prior to using licensed material.

Section 34.43{D requires that the licensee maintain records of training to include oral, written, and practical examinations, re% sher safety training, and semi-annual inspections of jou performance, and that these r.nords be maintained in accord with 34.79 and kept for 3 years after the record is made. These records are needed to enable licensees to adequately administer their training program and to demonstrate compliance with NRC requirements. The need for retention of these records for a period of 3 years allows the NRC to inspect to ensure that itwse individuals n properly trained.

l Section 34.45(a) requires that licensees have a program for routine operations snd emergencies for employces to follow in performing safety functions. This program, anu its essociated procedures, is necessary to ensure that individuals handling radioactive materia! will have guidance in appropriate!y carrying out safety functions and is to include: (1) safe hcndling and use of sealed sources and radiographic exposure devices, (2) conducting radiation surveys, (3) controlling access to radiographic areas, (4) locking and securing radiographn, exposure u.

5 devices, storage containers, and seated sources; personnel monitoring, (5) transporting sealed sources, (6) inspection, maintenance, and operabi2ty checks of radiographic exposure devices, (7) transport and storage containers, and suivey instruments, (8) steps to be taken if a pocl<et dosimeter reads off-scale, (9) identifying and reporting defects and noncompliance, (10) accident procedures, (11) minimizing exposure, (12) source recovery, and (13) maintenance of records. Section 34.45(b) requires that the licensee maintain copies of current operating and emergency procedures in accordance with 9 34.81 and 5 34.89. These records ais necessary to ensure that individuals hvie current procedures to use in the conduct of radiographic operations.

Section 34.47(b) requires radiographers to read and record the exposure on their direct reading dos meters (pocket dosinteters or electronic persona: dosimeters) at the beginning and end of each shift, and that records be maintained for 3 years after the record is made, as specified in Section 34.83(a). The requirement is to ensure that the licensee knows the radiation exposure a worker received during a given shift in case their film badge or TLD is lost, so that the licensee can take appropriate action (e.g., adjust the worker's assignments so as to maintain their accumulated dose within regulatory limits). These records are reviewed by NRC to ensure compliance with regulatory limits.

Section 34.47(c) requires that pocket dosimeters or electrcnic personal dosimeters be checked at periods not to exceed 12 months for correct response to radiation, and that records shall be maintained 'or 3 years after the record is made as specified in @ 34.83(a). These records are necessary for the licensee to be able to verify that the pocket dosimeter is responding correctly to radiation.

Section 34.47(d) requires that a determination of exposure be made if an individual's pocket dosimeter goes off-scale and that the result of the determination be maintained in accordance with @ 34.83(d). This requirement restricts individuals from working with radiation after a r

dosimeter discharges, unless any exposure 'o radiation can be ruled out or the RSO makes a determination of the individual's exposure and makes a record of that determination. This determination is needed to verify that an individual's dose does not exceed regulatory limits.

Sution 34.47(e) requirss that if a film badge or TLD is lost or damaged, the worker is required to cease work immediately until a replacement film badge or TLD is provided and the exposure is calculated for the time period from issuance to loss or damage. In addition, the results of the calculated exposure and the time period involved must M included in the records as specified in E 34.83(d). This r3quirerc.ent is also to ensure that a worker's dose does not exceed regulatory

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limits.

Egetion 34.4?(f) tuquires that the licensee maintain reports received from filn Sadge and TLD processors until the licqnse is terminated and that the record be maintained in accordance with @

34.83(c). This information may be needed to reconstruct a worker's dose history in the event they lose their records, to permit a planned special exposure, and to show compliance with regulatory limits.

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Section 34.47(o) requires that alarm ratemeters be calibrated at periods not to exceed one year for correct response to radiation and Section 34.47(a)(4) requires that the licensee must maintain records of the calibrations for 3 years after t' e record is made as specified in 9 34.83(b). Thi requirement provides a means for the licensees to demonstrate that their alarm ratemeters are properly calibrated.

i Section 34.49(c) requires that radiography licensees conduct a survey.of the radiographic exposure device whenever a source is exchanged or before placing a radiographic exposure device in storage if that survey is the last one performed on the workday, andamtipp 34.49(d) requires these surveys be recorded as specified under 9 34.85. This information is needed to demonstrate that the radioactive source is in the fully shielded position at the end of the work day after the device has been placed in its storage location. Without such a survey, the device t'ould, if the source is not fully shielded, cause excessive and unnecessary radiation exposure to

- workers and members of the public. These records are reviewed by NRC to ensure compliance with regulatory lim!s.

Section 34.61 requires the licensee to have a copy of the license, license conditions, documents incorporated by reference, and all amendments until the NRC terminates the license. The purpose is so that the licensee will have copies available for review and be able to verify that they are in compliance with the conditions of the license and the commitments that it has made.

Section 34.63 requires that the licensee maintain records showing 'ceipts and transfers of sealed sources and devices using depleted uranium IDU) shielding for 3 years after the record is made. The records must include: the date, the individual making the record, the radionuclide, number of becquerels (curies) or mass (for DU), and manufacturer, model, and serial number of each sealed cource and device, as appropriate. The records allow NRC inspectors to verify the sources / devices the licensee is presently using.

Section 34.65 requires that the lictensee maintain records of the calibrations of their radiation survey instruments, and that the records be retained for 3 years. The records allow NRC inspectors to verify that required calibrations have been performed. The licensee will use the records to assure itself that the instrumsats available to radiographers and radiographerc' assistants are properly calibrand. In addition, these records are necessary to verify that the licen=ee is in compliance with NRC requirements as described in 9 34.25, and to ensure the safety of the users of these instruments.

Section 34.67 requires that the licensee maintain records of leak test results and that the records be retained for 3 years. These records are necessary to verify that the licensee is in i

compliance with NRC requirements as described in 9 34.27, and for the licensee to ensure the integrity of the sealed sources / devices in use.

j Section 34.69 requires that the licensee maintain records of quarterly inventories of sealed

. sources and devices containing depleted uranium (DU) shielding as specified in 34.29.

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Section 34.69(a) requires that each record be retained for 3 gars after it is made. Section 34.69(b) requires that the record include the date of the inventory, the name of the individual conducting the inventory, the ladionuclide and the number of becquerels Icuries) in each device, location of sealehource and/or devices, and the manuf acturer, model, and serial number of

7 each sealed source and /or device, as appropriate. For devices containing DU shielding the record must also show the mass of DU in each container. The inventories are used by the licensee to verify the location of sources and/or devices and to control the type, quantity and use of byproduct material. The records allov; NRC inspectors to verify that the required inventories have been conducted and to ensure that the licensee is in compliance with authorized possession limits.

Section 34.71(a) requires that the licensee maintain utilization logs showing for each sealed radioactive source: (1) a description, including the make, model number a d serial number of the radiographic exposure device or transfer or storage container in which the sealed source is located; (2) the identity and signature of the radiographer to whom assigned; and (3) the plant or site where used and dates of use, including the datea removed from and retumed to storage.

Section 3471(b) requires that the licensee retain records of utilization logs for a period of 3 years after the record is made. The records required by this section allow NRC inspectors to determine whether the licensed material hrs been properly controlled and used.

Section 34.73(a) requires that the licensee maintain records of any equipment problems and any maintenance performed under 9 34.31(a) and (b) during inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments and that the records be retaincd for 3 years after they are made.

Section 34.73(b) states that records of equipment problems and maintenance as required by Section 34.73(a) must include the date of check or inspection, name of inspector, equipment involved, any problems found and what repair and/or maintenance, if any were done. The records are needed to enable the licensee to keep track of when the equipment was last inspected and maintained and when inspection is next due. The records are used by NRC staff to determine the extent of compliance by the licensee.

Section 34.75 rerpires that the licensee maintain records of the alarm system and entrance control device tests at permanent radiographic installations as specified under 9 34.33 and retain each record for 3 years after it is made. The records are needed to enable the licensee to keep track of when entrance control and alarm system tests were last performed and when they are next duo. The records are also used by NRL inspectors to determine compliance with required testing of important safety equipment.

Section 34.79 requires that the licensee maintain records of training of radiographers and radiographers' assistants in accordance with 9 34.43(f). Section 34.79(a) requires that the record includes certification documents, copies of written tests, dates of practical examinations, and names ofindividuals conducting and receiving the practical examinations. Section 34.79(b) requires that records of refresher srfety training and semi-annual inspections for each radiographer and each radiographers assistant be maintained. The records must list the topics discussed, the dates of the training, and names of the instructors and attendees. For the semi-annualinspections of each radiographer and radiographefs assistant by the RSO or designee, specified in 6 34.43(e), the records mus; ilso include a list of the items checked and any non-compliares observed. This is needed to enable licensees to demonstrate compliance with NRC requirements and to keep irack of when training is required. The records of the semi-

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annualinspections of job performance will be used by the licensee to ensure that workers are conducting operations in accord with the !icense. The records are used by NRC staff to determine the extent of compliance by the licensee Section 34.81 requires the licensee to retain records of current operating and emergency procedures specified in 6 34.45, until the Commission terminates the license. The records allow the operators to have access to an up-to-date set of wntien operating procedures so that they can operate the radiography equipment properly. The NRC inspectors review these procedures to ensure that previous instructions are being provided to the workers.

Section 34.83 requires licensees to maintain exposure records specified in 34.47 as follows:

(a) direct reading dosimeter readings and yearly operability tests and retain for 3 years after the record is made, (b) records of alarm ratemeter calibrations and retain them for 3 years from the date the record was made, (c) reports from film badge or TLD processor until the Commission terminates the license, and (d) records of estimates of exposures as a result of off-scale parsonal direct reading dosimeters or lost or damaged film badges or TLDs until the Commiss'on terminates the license. The records serve as an important mechanism for controlling exposure on a day-to-day basis, provide indications of inadvertent exposure, and provide a backup record of estimated exposure in case a film badge or thermoluminescent dosimeter is lost. The records are used by NRC staff to determine the extent of compliance by the licensee.

S.ection 34 05 requires the licensee to maintain a record of the last survey made on each j

radiographic exposure device on each day it is used, just prior to placing the device in storage, i

as specified in S 34.49(c). Each record must be maintained for 3 years cfter it is made. These records enable the licensee to verify that the required radiation surveys have been done and that they are in compliance with the radiation dose limits.

Section 34.89(a) requires licensees to maintain copies of records required by this part and other applicable parts of this chapter at the location specified in 34.13(k) to demonstrate compliance with NRC regulations in conducting radiographic operations and to ensure that adequate information is available to safely handle radioactive material.

l Section 34.89(b) requires licensees to maintain copies of documents and records sufficient to i

demonstrate compliance at any field stations and each temporaryjobsite as applicable. The purpose is to demonstrate compliance with NRC regulations in conducting radiographic operations and to ensure that adequate information is available at sites where radioactive t

material is handled. These documents and records include: (1) the license authorizing the use of licensed material; (2) a copy of Parts 19,20, and 34 of NRC Regulations; (3) utilization records for each radiographic exposure device dispatched from that location as required by 9 34.71; (4) records of equipment problems in daily checks of equipment as required by 6 34.73(a); (5) records of alarm system and entrance control checks required by 34.75, if I

applicable; (6) daily pocket dosimeter readings as required by $ 34.47(b); (7) operating and l

emergency procedures required by @ 34.45; (8) evidence of the latest calibration of the radiation survey instrument in use at the site, as required by g 34.65; (9) evidence of the latest calibration of alarm ratemeters and operability checks of pocket dosimeters as required by 34.47(c),

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(10) latest survey records required by 9 34.85; (11) the shipping papers for the transpodation of radioactive materials required by 5 71.5 of this chapter; and (12) when operating 'mder reciprocity pursuant to 5150.20 of this chapter, a copy of +he Agreement State license authorizing the use oflicensed materials.

I Section 34.101(a) requires written reports within 30 days of the occurrence of the following:

1) unintentional disconnection of the source assembly,2) inability to retract the source assembly to its fully shielded position and secure it in this position, and 3) failure of any component critical to safe operation to properly perform its intended function.

Section 34.101(b) specifies that the report required under Section 34.101(a) is to include: 1) description of the equipment problem,2) cause of the problem,3) manufacturer name and model number of equipment involved,4) date, time and place of the incident, 5) actions taken to establish normal operations,6) corrective action (s) taken to prevent recurrence, and

7) qualifications of personnel involved in incident.

l Section 34.101(c) requires the licensee to notify the appropriate NRC regional office in writing within 30 days prior to conducting radiographic operations or stYng radioactive materialin excess of 180 days at any location not listed on the license. Tk :.e requirements are necessary in order to provide the NRC with information in a timely manner to permit inspection of radioactive material at these locations to ensure that they are in compliance with NRC safety regulations.

The following describes the information collection requirements of Appendix A to 10 CFR 34.43(a) and their need and practical uti'ity. Ar.pandix A specifies the requirements to be an independent organization and the certification program criteria all organizations must address.

Appendix A does not impose requirements on NRC's radiography licansees. Psrt I of the Appendix provides the requirements to be an independent certifying organization. Parts 11 and 111 provide the requirements for the certification program and written examinations for a certifying entity, including the Agreement States. NRC anticipates that certifying entities will maintain their program procedures as long as the organization is identified by NRC as a certifying entity.

For information required under each Part of Appendix A, NRC would review the program description to ensure that it includes the elements in that Part.

i Anoendix A. Part I. item 6 requires that an independent certifying organization have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies. The procedures are needed to ensure the independent certifying organization has a program in place for j

monitoring and enforcing its by-laws and policies.

Aooendix A. Part 1. iter" C tequires that an independent certifying organization have written procedures describing all aspects of its certification program, maintain records of the current statua of each individual's certification and the administration ofits certification program. The procedures are needed to ensure that the independent certifying organization has an adequate certification program. The records are needed by the certifying organization to maintain an I

m

I 10 awareness of each individuars certification, and to record its activities on the administration of its certification program. They would review the records during periodic program reviews.

i l

Anoendix A. Part I. item 10 requires that an independent certifying organization have procedures I

I to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of be. coming certified and any sanctions imposed against certified individuals. The procedures are needed to ensure that the independent certifying organization provide certified individuals adequate due process.

Anoendix A. Part I. item 11 requires that an independent certifying organization have procedures for proctoring examinations and for ensuring that the individuais proctoring each examination are not employed by the same company or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examines. The procedures are needed to help ensure fairness in the examination process.

Accendix A. Part 1. item 12 requires that independent certifying organizations and/or Agreement States exchange information about certified individuals with the Commission and the Agreement States. This information is needed to ensure that knowledge about certified individuals is shared between the regulatory bodies and the certifying organization.

Accendix A. Part I. item 13 requires that an independent certifying organization provide a description to the Commission of its procedures for choosing examination sites and for providing an appropriate examination environment. The procedures are needed to ensure that the independent certifying organization provide for appropriate examination sites and environments.

Anoendix A. Part II. item 2 requires that a certification program must require applicants for certification to provide documentation that demonstrates that the applicant has: (a) received training in the topics set forth in Appendix A to this part; (b) satisfactorily completed a minimum period of on-the-job training; and (c) received verification by an Agreement State or a NRC licensee that the applicant has demonstrated the capability of independently working as a radiographer. Submission of this documentation to th3 certifying organization is necessary for the certifying organization to verify an applicant's training and to determine that the applicant meets certain certification criteria.

Anoendix A. Part II item 3 requires that a certification program must include procedures to ensure that all examination questions are protected from disclosure. The procedures are intended to ensure that the examinees will not have access to certification examination questions.

AnoendiY A. Pa-t II. item 4 requires that a certification program must include procedures whereby an application can be denied or a certification revoked, suspended, and reinstated.

NRC would review the program description to ensure that it includes this element. The -

procedures are intended to ensure that the certification program include provisions for denyir.g applications, revoking, suspending, and reinstating an individuars certification.

.~ Anoendix A. Part II. item 6 requires that a certification program must include procedures for renewing the certifications and, if the procedures allow renewals without examiration, require

_n-_...

l 11 evidence of recent active full-time employment and annual refresher training. The procedures are intended to ensure that the certification program include provisions for certification renewal.

Accendix A. Part II. item 7 requires that the certification program provide for timely responses to public enquiries conceming an individual's certification status.

2.

Acency Use of the Information The NRC uses the information required by this part, including the records that 10 CFR part 34 requires licensees to maintain, during the application process, inspections, license renewals, and license amen 6 aent reviews to assure that licensees are complying with NRC radiation safety requirements for possession and use of licensed radioactive material in radiography.

3.

Reduction of Burden Throuch Information Technolooy l

There are no legal obstacles to reducing the burden associated with this information collection.

However, because of the types of information, including the need for signature of a responsible individual, and the infrequency of submission, the application form and reports do not lend themselves readily to the use of automated information technology for submission.

)

4.

Effort to identifv Duolication and Use Similar Information The information Requirements Control Automated System (IRCAS) was searched to identify duplication. None was found. There is no similar information available to the NRC.

5.

Effort to Reduce Small Business Burden Many NRC radiography licensees are small businesses. Efforts have been made to keep the requirements for information to a minimum. However, since the health and safety consequences of improper handling or use 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.

6.

Consecuences to Federal Procrams or Poliev Activities if the Collection is not Conductesi or is Conducted less Frecuentiv If the information collection was not conducted, or was conducted less frequently, NRC would nct have the information needed to assure that licensees are conducting and will continue programs in a manner that will assure adequate protection of public health and safety. Required reports are collected and evaluated on a continuing basis as events occur. Applications for new licenses and amendments are submitted only once. Application for renewal of licenses are submitted every ten years. Information submitted in previous applications may be referenced without being resubmitted.

7.

Circumstances Which Justifv Variation from OMB Guidelines

12 Section 34.27(d) varies from OMB guidelines in requiring that licensees report within 5 days of the leak testing any result which would indicate that a source is leaking. This requirement for a report in less than 30 days is necessary because a leaking source could present a radiological hazard to workers and the public, and NRC must be notified promp+!y in order to be able to assess whether corrective actions initiated by the licensee are adequate.

Section 34.83(c) requires that licensees maintain reports received from the film badge or TLD processor. This requirement restates existing requirements in 10 CFR Part LO, which is cleared under OMB clearance number 3150-0014.

Section 34.83(d) varies from OMB guidelines by requiring that licensees maintain records of estimates of exposures as a result of off-scale pocket dosimeters or lost or damaged film i

badges or TLDs until the Commission terminates the license. This information may be needed to reconstruct a worker's dose history in the event they lose their records, and to permit a planned special exoosure.

l 8.

Consultations Outside the NRC An opportunity to comment on the information collection requirements in 10 CFR Part 34 is being provided in the Federal Reoister Notice published for this clearance extension.

l 9.

Payment or Gift to Resoondents Not Applicable.

i

10. Confidentialifv of Information None, except for proprietary information.

11. Sensitive Out stions None.

L

12. Estimated Burden and Burden Hour Cost i

See Tables 1 and 2 for the annualized recordkeeping and reporting burdens and costs for NRC licensees. Total 10 CFR Part 34 burden for recordkeeping and reporting is estimated to be 60,285.3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />. Total cost for licensees is estimated at 57,535,662.5 ($125/hr X 60,285.3 hrs).

The estimates are based on submittals to NRC in past years. In addition, there is a burden for completing NRC Form 313 that has been previously approved by OMB under clearance number 3150-0120 which should be referred to for burden estimates.

Aoreement State Burden and Cost

l l

13 it is estimated that, for Agreement State licensees and applicants, there will be 146 responses and 213 burden hours annually, and there will be a recordkeeping burden of 120,570.6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />.

I Therefore, total cost is $ 15,097,950 (213+120,570.6 hrs x $125).

l

13. Estimate of Other Additional Cost.

I Not applicable.

14. E!ihmated Annualized Cost to the Federal Govemmertt The estimated snnual cost of prufessional staff effort for activities other than application review l

is $7,312.5 (58.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> @ $125/hr) (see Table 3). Application review and other administrative and clerical activities are attributable to and reported under the clearance for NRC Form 313, OMB No. 3150-0120, which should be referred to for additional burden and cost information.

These costs are fully recovered through fee assessments to NRC licensees pursuant to 10 CFR l

Pads 170 and 171.

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15. Reason for Chance in Burden or Cost l

The change in burden reflects the addition of Agreement State burden for the first time, the reduction in the number of NRC licensees from 450 to 158, and experience with radiography licensees operating under a revised Part 34.

16. Publication for Statistical Use None.

17. Reason for Not Disolavino the Exoiration Date The requirement is contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.

18. Exceotions to the Certification Statement None.

B. Collections ofInformation Emolovino Statistical Methods Statistical methods are not employed in this collection of information.

I 14 TABLE 1 ANNUAL INFORMATION COLLECTIOt. 2 TDENS ASSOCIATF?#!)TH RECORCKEEPING REC""REMEL.o OF 10 CFR PAP.T 34 e

i Section No. nf Hrs per Total Annual Annual Cost Record Notes Reco 4 Rc.:ord-Recordkeepi g at Si25/hr Refeation

}

keepers keeoer Burden (br)

Pe' id 34.20(b)(1) 158 0.4 63.20 7,900.00 Labels 34.25(c) 158 0.00 0.00 3 (te see

@ 34.65

}

34.27(c)(2) 158 l 0.00 0.00 3 Yrs Isee

@ 34.67 34.17(e)

15t, 0.00 0.00 3 Yrs see

@ 34.67 34.29(b) 158 0.00 0.00 see

@ 34.69 34.31(b)&

158 0.00 0.00 r,ac 34.31(c)

@ S4.73 34.33(b) 40 0.00 0.00 see

@ 34.75 24.35(a) 158 0.8 126.40 15,800.00 3%

3M 35(b)(2) 150 36 5,688.00 711,000.00 3 Yrs 1

S t.A?!b)(1) &

158 2.5 395.00 49,375 00 34.43 (c)(1)

P 8

I t 34.43(f) 58 0.00 0.00 see 34.79 34.45(b) 158 0.00 0 00 RULT ree j

@ 34.81 SUETOlAL 6,272.60 784,075.00 l

S-m E

[

Not): 1. Retain until Geene.e is terminated I

Mb__-

mm f

u 7

Annual Cost Record Notes Total Annual Retention Hrs per at $125/hr Aection j Mo. of Record-Recordkeeping Period f decord-Burder. (hrs) i Keepers 0.00 3 Yrs see keeper 1, 9 34.83(a) 0.00 158 34.47(b) i 0.00 3 Yrs

! see 1

(

0.00

@ 34.83(a) l 158 34.47(c) 0.00 RULT see 0.00

@ 3e!3(d)

_l l

158 0.00 RUl.T' see 34.47(d) 1 0.00 S 34.83(d)

_l 158 34.47(o) l 0.00 RULT see 0.00 34.83(c) 15c l

l see 14.47(f) 0.00 3 Yrs 0.00

@ 34.83(b) J

)

'I24 47(g)(4) 0.00 9 34.85 158 see

~

0.00 3 Yrs l

l r

158 1/ 34.49(d) 3,160.00 RU!.T' 25.28 l

158' O.16 31,600.00 3Yn

]

l 34.61 252.80 1.6 158 31,600.00 3 Yrs l

t 34.63 252.80 1.6 23,700.00 3 Yrs

]l 158_i 34.65 189.60 1.2 158 39,500.00 3 Yrs 34.67 316.00 2

l 158 711,000 00 3 Yrs

]

34.69 5,688.00 36 l

159 533,250.00 3 Yrs l

34.71 4.266.00 27 some new I

150 241,000 00 3 Yrs j

info 34.73 1,928.00 f

40 48.2 4

34.75 98,750.00 3 Yrs f

790.00 5

158 1.713.560 00 j 34.79 13.708 48,

I I

SUBIOTAL l

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16 Section No. of Hrs. per Total annual Annual Cost Record

• Notes Record-record-recorr' keeping at $125/hr _

Retention keepers

.keepe.'

burdan (hrs)

Period 34.81-158 0.08 12.64 1,580.00 RULT' 34.83(a) ~

158 122.5 19,355.00 2,419,375.00 3 Yrs em=

34.83(b) 158 2.5 395.00 49,375.00 3 yrs 34.83(d) 158 3.2 505.60 63,200.00 3 Yrs 34.85 158 120 18,960.00 2,3/0,000.00 3 Yrs 34.89 158 5.4 853.20 106,650.00 RULT Appendix A, 1

10 10.00 1,250.00 life of Pcrt I, item 6 program Appendix A.

1 158 158.00 19,750.00 life of Part I, item 9 program h

Appendix A, 1

10 10.00 1,250.00 life of Pzrt I, item 10 program Appendix A, 1

10 10.00 1,250.00 life of F

Pcrt I, item 11 program Appendix A, 1

10 10.00 1,250.00

! ifs of Prrt I, item 13 program 2 SUBTOTAL ~

4027144 5 034 930 00 t

2 T

?R. rein until doense is terminated.

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j

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I Section No. of Hrs per Total annual.

Annual cost -

Record Notes j

Record-Record-recordkeeping at $125/hr Retention j

keepers keeper burden (hrs)

Period

]

Anpendix A.

158 1

158.00 19,750.00 life of j

l Part 11, item 2 '

program

' Appendix A,.

1 10 10.00 1,250.00 life of

{

P rt il, item 3 program Appendix A, 1

10 10.00 1,250.00 life of-

~

Pcrt II, item 4 program 4

Appendix A,-

1 10 10.00 1,250.00 life of

-l PIrt 11, item 6

,arogram - I Appendix A, 200 0.5 100.00 12,500.00 l

l Part il i

it:m 7 TOTALS 60,178.80 7,522,350.00 t

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a s

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18 TABLE 2 ANNUAL INFORMATION COLLECTION BURDENS ASSOCIATED WITH REPORTING REQUIREMENTS OF 10 CFR PART 34 SECYlON No. Licensee Hours per Total Annual Cost Report Notes Responses _

Licensee Annual at $125/hr Retention Annually

Response

Burden (hr)

Period 34.27(d) 1 4

4.00 500.00 34.101 (a and b) 5 10 50.00 6,250.00 34.101 (c) 65 0.5 32.50 4,062.50 Appendix >; Part I, 2

10 20.00 2,500.00 life of

, _m 12 progtam P

_OTAL-73 106.50 13,312.50

(

__j

l t

i 19 i

TABLE 3 i

ESTIMATED ANNUALIZED COST TO THE FEDERAL GOVERNMENT FOR REVIEW OF REPORTS ASSOCIATED WITH 10 CFR PART 34 I

Section No. - of Fed Govt Staff Hours--

Annual Federal Government Cost at j

Ucensee Per Response

$125/h!

j Responses -

34.27(d) 1 4

500.00 j

)

34.101(a and b) 5 4

2,500.00 1

{

34.101(c) :

65 0.5 4.062.50 Appendix A Part I, item 12 2

1' 250.00 l

TOTAL 73.00 7.312.50 i

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