ML23194A135

OMB 3150-0007, Final Supporting Statement for 10 CFR Part 34, Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations

ML23194A135
Person / Time
Issue date:	09/07/2023
From:	Office of Nuclear Material Safety and Safeguards, NRC/OCIO
To:
Vanessa Cox
References
OMB 3150-0007
Download: ML23194A135 (18)

Text

FINAL OMB SUPPORTING STATEMENT FOR 10 CFR PART 34 LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS (3150-0007)

EXTENSION

Description of the Information Collection

U.S. Nuclear Regulatory Commission (NRC) regulations in Title 1 0 of the Code of Federal Regulations (10 CFR) Part 34 establish rules that specify radiation safety requirements for the issuance of licenses for the use of sealed sources containing b yproduct material and radiation safety requirements for persons using these sealed sources in i ndustrial radiography.

The requirements in Part 34 specify what information must be su bmitted in an application for a license to conduct industrial radiography, including, for examp le, the applicants program for training radiographers and radiographers' assistants, procedures for verifying and documenting the certification status of radiographers, written operating an d emergency procedures, and a description of the applicant's organizational structure as it a pplies to the radiation safety responsibilities in industrial radiography.

The information required by Part 34 is collected to ensure that an applicant for a license to conduct industrial radiography is properly qualified to perform this activity and to ensure the safety of employees and members of the public. The regulations provide for comprehensive and consistent radiation safety requirements in NRC and Agreement S tate regulations and safety requirements designed to reduce the likelihood of accidents inv olving radioactive sources in industrial radiography.

Persons affected by the information collection requirements of Part 34 include applicants for and holders of NRC and Agreement State licenses to conduct industri al radiography.

A. Justification

1. Need for and Practical Utility of the Information

Part 34 provides certain requirements exclusive to licensees us ing byproduct material for purposes of industrial radiography, a technique of nondestr uctive testing. The byproduct material is normally employed in the form of sealed s ources 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 sev eral 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 job site, and also transported from job site to job site. The many manipulations o f the sources and movement and transport of the devices result in unique and cont inuing potential and actual hazardous radiological conditions.

Information collections in 10 CFR Part 34 are listed in Appendi x A.

2. Agency Use of the Information

The NRC uses the information required by this part, including t he records that 10 CFR Part 34 requires licensees to maintain during the applic ation process, inspections, license renewals, and license amendment 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 Through Information Technology

The NRC has issued Guidance for Electronic Submissions to the NRC which provides direction for the electronic transmission and submitta l of documents to the NRC. Electronic transmission and submittal of documents can be accomplished via the following avenues: the Electronic Information Exchange (EIE) process, which is available from the NRC's Electronic Submittals websi te, by optical storage media (e.g., CD-ROM, DVD), or by email. It is estimated that approximately 90 percent of the responses are filed electronica lly.

4. Effort to Identify Duplication and Use Similar Information

No sources of similar information are available. There is no du plication of requirements.

5. Effort to Reduce Small Business Burden

Most of the NRC radiography licensees are small businesses. Eff orts have been made to keep the requirements for information to a minimum. How ever, 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 n ot possible to further reduce the burden on small businesses by less frequent or less complete recordkeeping or reporting.

6. Consequences to Federal Programs or Policy Activities if the Co llection is not Conducted or is Conducted Less Frequently

If the information collection was not conducted, or was conduct ed less frequently, the NRC would not have the information needed to assure that licens ees are conducting and will continue programs in a manner that will assure adequat e protection of the public health and safety. Required reports are collected and ev aluated on a continuing basis as events occur. Applications for new licenses and amendments are submitted only once. Applications for license renewals are subm itted every 15 years.

Information submitted in previous applications may be reference d without being resubmitted.

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7. Circumstances Which Justify Variation from OMB Guidelines

Section 34.27(d) varies from OMB guidelines in requiring that l icensees 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 beca use 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 correct ive actions initiated by the licensee are adequate.

Section 34.61 varies from OMB guidelines in requiring that lice nsees maintain a copy of the license, license conditions, documents incorporated by refe rence, and all amendments until the NRC terminates the license. This informati on is needed so that the licensee will have copies available for review and be able to verify that it is in compliance with the conditions of the license and the commitmen ts that it has made.

Section 34.81 varies from OMB guidelines by requiring that lice nsees retain records of current operating and emergency procedures specified in Section 34.45, until the Commission terminates the license. This information is needed s o that operators have access to an up-to-date set of written operating and emergency procedures so that they can operate the radiography equipment properly and plan accordi ngly for emergencies.

Section 34.83(c) requires that licensees maintain reports recei ved from the personnel dosimeter processor. This requirement restates existing require ments in 10 CFR Part 20, which is cleared under OMB clearance number 315 0-0014.

Section 34.83(d) varies from OMB guidelines by requiring that l icensees maintain records of estimates of exposures as a result of off-scale pock et dosimeters or lost or damaged personnel dosimeters until the Commission terminates th e license. This information may be needed to reconstruct a worker's dose histor y in the event the worker loses his/her records, and to permit a planned special e xposure.

Section 34.89(a) requires licensees to maintain certain documen ts and records at specified locations. The retention periods for the various docu ments vary and may be required for as long as the license is in effect. This informat ion is needed at the various sites so that the licensee's operating personnel can ha ve easy access to the documents they need to perform the job safely.

Section 34.89 (b) requires licensees conducting operations at t emporary job sites to maintain certain documents and records at each temporary job si te. The retention periods for the various documents vary and may be required for as long as the license is in effect. This information is needed so that the licensee's operating personnel can have easy access to the documents they need to perform the job safely.

Appendix A requires the development of procedures, policies, an d application records in various sections of the Appendix. The expectation is that a certifying entity would maintain copies of these procedures throughout the life of the program or as long as an individuals certification remains in effect. The retention is necessary to ensure the certifying entity maintains an up-to-date description of its pr ogram and records of the certifications issued.

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8. Consultations Outside the NRC

Opportunity for public comment on the information collection re quirements for this clearance package was published In the Federal Register on April 20, 2023 (88 FR 24453). Through the email, four testing and inspection r adiography licensees were contact as part of the consultation process. No comments were received in responses to these consultations.

9. Payment or Gift to Respondents

Not Applicable.

10. Confidentiality of Information

Confidential and proprietary information is protected in accord ance with NRC regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b). However, no information normally considered confidential is requested, although proprie tary information may be submitted.

11. Sensitive Questions

None.

12. Estimated Burden and Burden Hour Cost

The estimates are based on submittals to NRC in past years.

The number of NRC licensees is known, whereas the total number of Agreement State licensees is an estimate based on NRCs best information available from the Agreement States. The NRC uses the ratio of the total of NRC li censees to the total number Agreement State licensees to estimate the number o f Agreement State respondents for each section. The NRC uses this ratio app roach as the total number of Agreement State licensees subject to various Pa rt 34 Sections is not known exactly and, therefore, must be estimated. For the es timates in this document, NRC used a ratio of 7.3 Agreement State licensees to every one NRC licensee.

A summary of the burden and responses are in the tables below. The details of the burden for the reporting, recordkeeping, and third-party di sclosure requirements are shown in Tables 1, 2, and 3, respectively on t he spreadsheet submitted as a supplemental document to this submission.

4 TOTAL BURDEN FOR 10 CFR 34 NRC Agreement Licensees State Total Cost at $290/hour Licensees Reporting 240.00 3,574.00 3,814.00 $1,106,060.00 Recordkeeping 26,462.44 191,515.08 217,977.52 $63,213,480.80 Third-Party Disclosure 2,620.20 19,135.40 21,755.60 $6,309,124.00 TOTAL 29,322.64 214,224.48 243,547.12 $70,628,664.80

TOTAL RESPONSES FOR 10 CFR 34

NRC Licensees Agreement State Licensees Total

Reporting 24 175 199 Recordkeeping 66 482 548 Third-Party Disclosure 264 1,927 2,191 TOTAL 354 2,584 2,938

The total number of respondents is 548 (66 NRC licensees plus 4 82 Agreement State licensees). The total number of reports is 199 (24 NRC licensee s plus 175 Agreement State licensees). The total number of responses for Part 34 is 2,938 (199 reporting responses plus 548 recordkeepers) plus 2,191 third party disclo sure responses).

The total burden and cost for Part 34 is 243,547.12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> at a cost of $70,628,664.80 (243,547.12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> x $290/hour). The burden estimates are based on staffs best estimate of the time required to perform information collection activities. Cost estimates are based on the rate used in NRCs license fee rule.

The $290 hourly rate used in the burden estimates is based on t he NRCs fee for hourly rates as noted in 10 CFR 170.20 Average cost per profes sional staff-hour. For more information on this rate, see the Revision of F ee Schedules; Fee Recovery for Fiscal Year 2023 (87 FR 37197).

13. Estimate of Other Costs

The quantity of records to be maintained is roughly proportiona l to the recordkeeping burden. Based on the number of pages maintained for a typical c learance, the records storage cost has been determined to be equal to 0.0004 times the recordkeeping burden cost. Therefore, the storage cost for this clearance is estimated to be $25,285 (217,977.52 hours6.018519e-4 days <br />0.0144 hours <br />8.597884e-5 weeks <br />1.9786e-5 months <br /> x $290 x 0.0004)

14. Estimated Annualized Cost to the Federal Government

The staff has developed estimates of annualized costs to the Fe deral Government related to the conduct of this collection of information. These estimates are based on staff experience and subject matter expertise and include the b urden needed to

5 review, analyze, and process the collected information and any relevant operational expenses.

For the requested clearance period, the annualized burden and c ost to NRC staff for review of reports under Part 34 is estimated to be 117 hours0.00135 days <br />0.0325 hours <br />1.934524e-4 weeks <br />4.45185e-5 months <br /> an d $33,930 (117 hours0.00135 days <br />0.0325 hours <br />1.934524e-4 weeks <br />4.45185e-5 months <br /> x $290).

15. Reason for Change in Burden or Cost

The total burden decreased by 27,685 hours0.00793 days <br />0.19 hours <br />0.00113 weeks <br />2.606425e-4 months <br />, from 270,760 to 243,075 hours8.680556e-4 days <br />0.0208 hours <br />1.240079e-4 weeks <br />2.85375e-5 months <br />. The burden for NRC and Agreement State licensees changed as follows :

• NRC Licensees. The overall burden for NRC licensees decreased b y 3,863 hours0.00999 days <br />0.24 hours <br />0.00143 weeks <br />3.283715e-4 months <br /> (from 33,185 to 29,322). The burden decreased due to the decrea se in the number of NRC licensees by eight, from 74 to 66 since the last renewal.

• Agreement State Licensees. The burden for Agreement State licen sees decreased by 23,350 hours0.00405 days <br />0.0972 hours <br />5.787037e-4 weeks <br />1.33175e-4 months <br /> (from 237,575 to 214,225). The number of NRC li censees is known, whereas the total number of Agreement State licensees is an est imate based on NRCs best information available from the Agreement States. The NRC uses the ratio of the total of NRC licensees to the total number Agreeme nt State licensees to estimate the number of Agreement State respondents for each sec tion. The NRC uses this ratio approach as the total number of Agreement State licensees subject to various Part 34 Sections is not known exactly and, therefore, m ust be estimated.

The ratio used to estimate Agreement State respondents changed from 7.2 to 7.3.

The number of Agreement State licensees decreased by 51, from 5 33 to 482.

The current submission has correctly identified all respondents, including licensees reporting information to the NRC as well as those required to r etain records. The number of respondents has decreas ed from 607 to 548 (66 NRC licensees plus 482 Agreement State licensees). Note that licensees reporting i nformation are a subset of the licensees who are recordkeepers, and do not repre sent an additional group of licensees.

The number of responses has decreased from 3,296 to 2,938 due t o the number of events reported in the Nuclear Materials Events Database. The t otal number of responses per year decreased from 37 to 24. The total burden ho urs per year decreased from 635.50 to 240. All the events reported were equi pment failure or malfunction issues under Part 3.4.101 (a)&(b).

The professional cost increased from $278/hour to $290/hour.

The number of NRC licensees is expected to remain at or near th e current number (66) over the coming 3 years. This assumption is based on the change from the previous clearance period. The number of Agreement State licensees is li kewise expected to remain at or near the current number (482) over the coming 3 ye ars.

16. Publication for Statistical Use None.

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17. Reason for Not Displaying the Expiration Date

The recordkeeping and reporting requirements for this informati on collection are associated with regulations and are not submitted on instrument s such as forms or surveys. For this reason, there are no data instruments on whic h to display an OMB expiration date. Further, amending the regulatory text of the C FR to display information that, in an annual publication, could become obsole te would be unduly burdensome and too difficult to keep current.

18. Exceptions to the Certification Statement None.

B. Collections of Information Employing Statistical Methods

Statistical methods are not employed in this collection of info rmation.

7 Appendix A

10 CFR Part 34 Information Collection Requirements

Section 34.1 provides that an applicant must submit the followi ng information with the application:

34.13(b): Schedule and description of training programs for rad iographers and radiographers assistants that meet the requirements of § 34.43 ;

34.13(c): Procedures to verify and document the certification s tatus of the radiographers it employs, including that the certification is valid;

34.13(d): Written operating and emergency procedures as described in § 34.45 covering its radiation safety program;

34.13(e): Program for semiannual inspections of the job performance of ea ch radiographer and radiographers assistant as described in § 34.43;

34.13(f): Description of overall organizational structure as it applies to radiation safety responsibilities in radiography, including specified delegations of responsibility and authority;

34.13(g): Identification and listing of the qualifications of the individ ual designated as the Radiation Safety Officer (RSO), responsible for implementing th e licensees radiation safety program, as described in § 34.42;

34.13(h): For applicants who intend to perform leak testing of sealed sou rces or exposure devices containing depleted uranium (DU) shielding, a description of procedures for performing the tests and the qualifications of t he person(s) authorized to do the leak testing; also, if the applicant inten ds to analyze its own leak test wipe samples, a description of the procedures to be followed;

34.13(i): If the applicant intends to perform its own calibrations, a des cription of the methods to be used and the relevant experience of the person(s) who will perform the calibrations;

34.13(j): An identification of locations of and a description o f all field stations and permanent radiographic installations; and

34.13(k): Specification of location where all documents and rec ords required by this part and other parts of this chapter will be maintained as specified in §34.89.

This information is reviewed by the NRC staff to determine whet her the training, radiation safety, and internal inspection programs and procedures and the license e's organizational structure will provide adequate protection of the public health and safety. Th e NRC review and the findings therefrom form the basis for NRC licensing decisions.

Section 34.20(b)(1) requires that each radiographic exposure de vice have an attached label bearing information identifying the radionuclide in the device, its activity, and the date the activity

8 was last measured, the manufacturer, serial, and model number, and the licensee's name, address, and telephone number. This information will serve as a safety notice to users and members of the public. The label requirement has been incorpora ted in the regulations, in part, in conformance with American National Standard Institute (ANSI) Standard N432.

Section 34.25(b) requires that each radiation survey instrument be calibrated at intervals not to exceed 6 months and after each instrument servicing, and Sectio n 34.25(c) requires that a record of the calibration be maintained in accordance with § 34.65. The radiation survey is one of the most important aspects of radiation safety, and the inst ruments must be periodically calibrated to assure reasonable accuracy when measuring radiati on levels that individuals are exposed to during radiographic operations. The licensee will us e the records to assure itself that the instruments available to radiographers and radiographe rs' assistants are properly calibrated. The records allow NRC inspectors to verify that req uired calibrations have been performed.

Section 34.27(c)(1) requires a licensee who uses sealed sources to have the source tested for leakage at intervals not to exceed 6 months, and Section 34.27( c)(2) requires the licensee to maintain records of leak test results of sealed sources in acco rdance with § 34.67. A leak test is the only effective method of determining the integrity of the s ealed sources. Serious radiological hazards could result from a leaking source. The records allow N RC inspectors to verify that required leak tests have been performed.

Section 34.27(d) requires that licensees report within 5 days r esults of leak testing which indicate that a source is leaking. The report must describe the equipmen t involved, the test results, and the corrective action taken. The NRC staff uses the report in a ssessing whether the corrective actions initiated by the licensee are adequate to protect worke rs and the public from the hazards of a leaking source. The NRC staff also uses the report to iden tify 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 thos e radiographic devices that use depleted uranium (DU) for shielding at least annually and maint ain records of these tests in accordance with § 34.67. These records allow the licensee and t he NRC to verify that the required tests have been performed to verify the condition of the S tu be.

Section 34.29(a) and (b) require that the licensee conduct a qu arterly 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 3 years from the date of the inventory. This information is used by the licensee and NRC to verify that all radioactive material is accounted for and is properly stored.

Sections 34.31(a), (b)(1), and (2) require that the licensee ha ve 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 materials.

Section 34.31(c) requires the license make a record of any equi pment problems and any maintenance performed during the daily visual and operability c hecks specified in § 34.31(a), or during the inspections specified in § 34.31(b), and specifies t hat these records must be made in accordance with § 34.73 with each record retained for 3 years a fter it was made. The records are needed for the licensee and NRC to verify that appropriate actions have been taken if

9 problems are found and to assist the licensee in keeping track of when the equipment was last inspected and maintained and when the inspection is next due. T he records are used by NRC staff to determine the extent of licensee compliance.

Section 34.33(b) requires that entrance controls and/or the vis ible and audible alarms on permanent radiographic installations required by Section 34.33( a) be tested and records of the tests maintained. Entrance controls are to be tested monthly wh ile both visible and audible alarms must be tested at the beginning of each day the installa tion is to be used in order to ensure that they are functioning properly to prevent inadverten t entry into a radiographic installation (cell) while a source is in the unshielded positio n. Records of the alarm tests and entrance control tests are to be maintained under § 34.75 for 3 years after they are made.

These alarms are an important backup to the radiation survey in strument and are intended to prevent inadvertent entry into a radiographic installation (cel l) while a source is in the unshielded position. These records are used by NRC to ensure compliance wi th its regulations regarding worker and public health and safety.

Section 34.35(a) requires that the licensee not use a source ch anger or container to store licensed material unless the source changer or the container ha s securely attached to it a durable, legible, and clearly visible label that indicates whom to notify in case of danger. This requirement ensures that any individual who may come in contact with the source changer or storage container is made aware of the presence of radioactive material and can notify the proper individual as necessary.

Section 34.35(b) requires that the licensee not transport licen sed material unless the material is packaged, labeled, marked, and accompanied with appropriate shi pping papers in accordance with regulations set out in Part 71. This is necessary so that the licensee may demonstrate that it is in compliance with regulations stated in Parts 34 and 71.

Section 34.41(c) requires applicants who intend to conduct lay barge, offshore platform, or underwater radiography, describe the procedures to be performed. This information is necessary because these activities require special operating an d emergency procedures that are not normally expected of most licensees.

Section 34.42(a) requires the licensee to have minimum qualific ations, training, and experience for RSOs for industrial radiography. This necessary to ensure c ompliance with its regulations regarding worker and public health and safety.

Section 34.42(c)(1) requires the licensee to establish and over see all operating, emergency, and ALARA procedures as required by 10 CFR Part 20 of this chap ter and review them regularly to ensure that the procedures in use conform to curre nt 10 CFR Part 20 procedures, conform to other NRC regulations and to the license conditions. These records are used by NRC to ensure compliance with its regulations regarding worker and public health and safety.

Section 34.42(c)(2) requires the licensee to oversee and approv e all phases of the training program for radiographic personnel, ensuring that appropriate a nd effective radiation protection practices are taught. These records are used by NRC to ensure c ompliance with its regulations regarding worker and public health and safety.

Section 34.42(c)(3) requires the licensee to ensure that requir ed radiation surveys and leak tests are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits. Th ese records are used

10 by NRC to ensure compliance with its regulations regarding work er and public health and safety.

Section 34.42(c)(4) requires the licensee to ensure that person nel monitoring devices are calibrated and used properly by occupationally-exposed personne l, that records are kept of the monitoring results, and that timely notifications are made as r equired by § 20.2203 of this chapter. The records allow NRC inspectors to verify that requir ed calibrations have been performed.

Section 34.42(c)(5) requires the licensee to ensure that operat ions are conducted safely and to assume control for instituting corrective actions including stopping of operations when necessary.

These records are used by NRC to ensure compliance with its reg ulations regarding worker and public health and safety.

Section 34.43(b)(1) requires the licensee to provide radiograph ers with copies of pertinent sections of Parts 19, 20, 30, and 34, as well as instructions i n applicable Department of Transportation regulations as referenced in Part 71, the NRC li cense, and the licensee's operating and emergency procedures. These are needed to ensure that radiographers are sufficiently knowledgeable of applicable regulations prior to u sing licensed material.

Section 34.43(c)(1) requires the licensee to provide radiograph ers' assistants with copies of pertinent sections of Parts 19, 20, 30 and 34, and instructions in applicable Department of Transportation regulations as referenced in Part 71, the NRC li cense, and the licensee's operating and emergency procedures. This is needed to ensure th at radiographers' assistants are sufficiently knowledgeable of applicable regulations prior to using licensed material.

Section 34.43(f) requires that the licensee maintain records of training to include oral, written, and practical examinations, refresher safety training, and semi annual inspections of job performance, and that these records be maintained in accord wit h § 34.79 and kept for 3 years after the record is made. These records are needed to enable li censees to adequately administer their training program and to demonstrate compliance with NRC requirements. The retention of these records for 3 years allows the NRC to inspec t to ensure that these individuals are properly trained.

Section 34.45(a) requires that licensees have a program for rou tine operations and emergencies for employees to follow in performing safety functions. This pr ogram, and its associated procedures, is necessary to ensure that individuals handling ra dioactive material will have guidance in appropriately carrying out safety functions and is to include: (1) safe handling and use of sealed sources and radiographic exposure devices, (2) co nducting radiation surveys, (3) controlling access to radiographic areas, (4) locking and s ecuring radiographic exposure devices, storage containers, and sealed sources; (5) personnel monitoring, (6) transporting sealed sources, (7) inspection, maintenance, and operability ch ecks of radiographic exposure devices, transport and storage containers, and survey instrumen ts, (8) steps to be taken if a pocket dosimeter reads off-scale, (9) identifying and reporting defects and noncompliance, (10) accident procedures, (11) minimizing exposure, (12) source reco very, and (13) maintenance of records.

Section 34.45(b) requires that the licensee maintain copies of current operating and emergency procedures in accordance with § 34.81 and § 34.89. These record s are necessary to ensure that individuals have current procedures to use in the conduct of radiographic operations.

11 Section 34.47(b) requires radiographers to read and record the exposure on their direct reading dosimeters (pocket dosimeters o r electronic personal dosimeters ) at the beginning and end of each shift, and that records be maintained for 3 years after th e record is made, as specified in

§ 34.83(a). The requirement is to ensure that the licensee know s the radiation exposure a worker received during a given shift in case the worker's perso nnel dosimeter is lost, so that the licensee can take appropriate action (e.g., adjust the worker's assignments so as to maintain the accumulated dose within regulatory limits). These records are r eviewed by NRC to ensure compliance with regulatory limits.

Section 34.47(c) requires that pocket dosimeters or electronic personal dosimeters be checked at periods not to exceed 12 months for correct response to radi ation, and that records shall be maintained for 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 m ade if an individual's pocket dosimeter goes off-scale and that the result of the determinati on be maintained in accordance with § 34.83(d). This requirement restricts individuals from wo rking with radiation after a dosimeter discharges, unless any exposure to radiation can be r uled out or the RSO makes a determination of the individual's exposure and makes a record o f that determination. This determination is needed to verify that an individual's dose doe s not exceed regulatory limits.

Section 34.47(e) requires that if a personnel dosimeter is lost or damaged, the worker is required to cease work immediately until a replacement film badge or the rmoluminescence dosimeter is provided and the exposure is calculated for the time period fro m issuance to loss or damage. In addition, the results of the calculated exposure and the time p eriod involved must be included in the records as specified in § 34.83(d). This requirement is als o to ensure that a worker's dose does not exceed regulatory limits.

Section 34.47(f) requires that the licensee maintain reports re ceived from personnel dosimeter processors until the license is terminated and that the record be maintained in accordance with

§ 34.83(c). This information may be needed to reconstruct a wor ker's dose history in the event the worker loses his/her records, to permit a planned spe cial exposure, and to show compliance with regulatory limits.

Section 34.47(g)(4) requires that alarm ratemeters be calibrate d at periods not to exceed 1 year for correct response to radiation, and that the licensee must m aintain records of the calibrations for 3 years after the record is made as specified in § 34.83(b). This requirement provides a means for the licensees to demonstrate that their alarm ratemet ers are properly calibrated.

Section 34.49(c) requires that radiography licensees conduct a survey of the radiographic exposure device whenever a source is exchanged or before placin g a radiographic exposure device in storage if that survey is the last one performed on t he workday, and

Section 34.49(d) requires these surveys be recorded as specifie d under § 34.85. This information is needed to demonstrate that the radioactive sourc e is in the fully shielded position at the end of the workday after the device has been placed in i ts storage location. Without such a survey, the device could, 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 limits.

12 Section 34.61 requires the licensee to have a copy of the licen se, license conditions, documents incorporated by reference, and all amendments until the NRC ter minates the license. The purpose is so that the licensee will have copies available for review and be able to verify that it is in compliance with the conditions of the license and the commit ments that it has made.

Section 34.63 requires that the licensee maintain records showi ng receipts and transfers of sealed sources and devices using DU shielding for 3 years after the record is made. The records must include: the date, the individual making the recor d, the radionuclide, number of becquerels (curies) or mass (for DU), and manufacturer, model, and serial number of each sealed source 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 licensee maintain records of th e calibrations of their radiation survey instruments, and that the records be retained for 3 year s. The records allow NRC inspectors to verify that required calibrations have been perfo rmed. The licensee will use the records to assure itself that the instruments available to radi ographers and radiographers' assistants are properly calibrated. In addition, these records are necessary to verify that the licensee is in compliance with NRC requirements as described in § 34.25, and to ensure the safety of the users of these instruments.

Section 34.67 requires that the licensee maintain records of le ak test results and that the records be retained for 3 years. These records are necessary to verify that the licensee is in compliance with NRC requirements as described in § 34.27, and f or the licensee to ensure the integrity of the sealed sources/devices in use.

Section 34.69(a) requires that the licensee maintain records of quarterly inventories of sealed sources and devices containing DU shielding as specified in § 3 4.29, and that each record be retained for 3 years after it is made.

Section 34.69(b) requires that the record include the date of t he inventory, the name of the individual conducting the inventory, the radionuclide and the n umber of becquerels (curies) in each device, location of sealed source and/or devices, and the manufacturer, model, and serial number of each sealed source and/or device, as appropriate. For devices containing DU shielding, the record must also show the mass of DU in each con tainer. The inventories are used by the licensee to verify the location of sources and/or d evices and to control the type, quantity and use of byproduct material. The records allow NRC i nspectors 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 utilizatio n logs showing for each sealed radioactive source: (1) a description, including the make, mode l number, and serial number of the radiographic exposure device or transfer or storage contain er 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 dates removed f rom and returned to storage.

Section 34.71(b) requires that the licensee retain records of u tilization logs for a period of 3 years after the record is made. The records required by this se ction allow NRC inspectors to determine whether the licensed material has been properly contr olled and used.

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

Section 34.73(b) states that records of equipment problems and maintenance as required by

§ 34.73(a) must include the date of check or inspection, name o f 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 equipme nt was last inspected and maintained and when inspection is next due. The records are use d by NRC staff to determine the extent of compliance by the licensee.

Section 34.75 requires that the licensee maintain records of th e alarm system and entrance control device tests at permanent radiographic installations as specified under § 34.33 and retain each record for 3 years after it is made. The records are neede d to enable the licensee to keep track of when entrance control and alarm system tests were last performed and when they are next due. The records are also used by NRC inspectors to determ ine compliance with required testing of important safety equipment.

Section 34.79 requires that the licensee maintain records of tr aining of radiographers and radiographers' assistants in accordance with § 34.43(f).

Section 34.79(a) requires that the record includes certificatio n documents, copies of written tests, dates of practical examinations, and names of individual s conducting and receiving the practical examinations.

Section 34.79(b) requires that records of refresher safety trai ning and semiannual inspections for each radiographer and each radiographer's assistant be maintain ed. The records must list the topics discussed, the dates of the training, and names of the i nstructors and attendees. For the semiannual inspections of each radiographer and radiographer's assistant by the RSO or designee, specified in § 34.43(e), the records must also includ e a list of the items checked and any noncompliance observed. This is needed to enable licensees to demonstrate compliance with NRC requirements and to keep track of when training is req uired. The records of the semiannual inspections of job performance will be used by the l icensee to ensure that workers are conducting operations in accordance with the license. The r ecords are used by NRC staff to determine the extent of compliance by the licensee.

Section 34.81 requires the licensee to retain records of curren t operating and emergency procedures specified in § 34.45, until the Commission terminate s the license. The records allow the operators to have access to an up-to-date set of written op erating procedures so that they can operate the radiography equipment properly. The NRC inspect ors review these procedures to ensure that previous instructions are being provided to the workers.

Section 34.83 requires licensees to maintain exposure records s pecified in § 34.47 as follows:

(a) direct reading dosimeter readings and yearly operability te sts and retain them for 3 years after the record is made, (b) records of alarm ratemeter calibr ations and retain them for 3 years from the date the record was made, (c) reports from personnel d osimeter processor until the Commission terminates the license, and (d) records of estimates of exposures as a result of off-scale personal direct reading dosimeters or lost or damaged personnel dosimeters until the Commission terminates the license. The records serve as an impo rtant mechanism for

14 controlling exposure on a day-to-day basis, provide indications of inadvertent exposure, and provide a backup record of estimated exposure in case a personn el dosimeter is lost. The records are used by NRC staff to determine the extent of compli ance by the licensee.

Section 34.85 requires the licensee to maintain a record of the last survey made on each radiographic exposure device on each day it is used, just prior to placing the device in storage, as specified in § 34.49(c). Each record must be maintained for 3 years after it is made. These records enable the licensee to verify that the required radiati on surveys have been done and that they are in compliance with the radiation dose limits.

Section 34.87 requires the licensee to maintain each record in a legible form, which may include electronic storage media, and that includes all pertinent infor mation throughout the specified retention period.

Section 34.89(a) requires licensees to maintain copies of recor ds 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.

Section 34.89(b) requires licensees to maintain copies of docum ents and records sufficient to demonstrate compliance at any field stations and each temporary job site as applicable. The purpose is to demonstrate compliance with NRC regulations in co nducting radiographic operations and to ensure that adequate information is available at sites where radioactive material is handled. These documents and records include: (1) t he 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 t hat location as required by

§ 34.71; (4) records of equipment problems in daily checks of e quipment as required by

§ 34.73(a); (5) records of alarm system and entrance control ch ecks required by § 34.75, if applicable; (6) daily pocket dosimeter readings as required by § 34.47(b); (7) operating and emergency procedures required by § 34.45; (8) evidence of the l atest calibration of the radiation survey instrument in use at the site, as required by § 34.65; ( 9) evidence of the latest calibration of alarm ratemeters and operability checks of pocket dosimeters as required by § 34.47(c); (10) latest survey records required by § 34.85; (11) the shipping pa pers for the transportation of radioactive materials required by § 71.5 of this chapter; and ( 12) when operating under reciprocity pursuant to § 150.20 of this chapter, a copy of the Agreement State license authorizing the use of licensed materials.

Section 34.101(a) requires written reports within 30 days of th e occurrence of the following: (1) unintentional disconnection of the source assembly, (2) inabili ty 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 fun ction.

Section 34.101(b) specifies that the report required under Sect ion 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 o f 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.

Section 34.101(c) requires the licensee to notify the appropria te NRC regional office prior to conducting radiographic operations or storing radioactive mater ial in excess of 180 days at any location not listed on the license. These requirements are nece ssary in order to provide the

15 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 § 34.43(a) and their need and practical utility. Appendix A specifies the requ irements to be an independent organization and the certification program criteria all organiz ations must address.

Appendix A does not impose requirements on NRC's radiography li censees. Part I of the Appendix provides the requirements to be an independent certify ing organization. Parts II and III provide the requirements for the certification program and writ ten examinations for a certifying entity, including the Agreement States. NRC anticipates that ce rtifying 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 wou ld review the program description to ensure that it includes the elements in that par t.

Appendix A, Part I, item 6 requires that an independent certify ing organization have a set of written organizational by-laws and policies that provide adequa te assurance of lack of conflict of interest and a system for monitoring and enforcing those by-law s and policies. The procedures are needed to ensure the independent certifying organization ha s a program in place for monitoring and enforcing its by-laws and policies.

Appendix A, Part I, item 9 requires that an independent certify ing organization have written procedures describing all aspects of its certification program, maintain records of the current status of each individual's certification and the administratio n of its 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 awareness of each individual's certification, and to record its activities on the administration of its certification program. They would review the records during periodic program reviews.

Appendix A, Part I, item 10 requires that an independent certif ying organization have procedures to ensure that certified individuals are provided du e process with respect to the administration of its certification program, including the proc ess of becoming certified and any sanctions imposed against certified individuals. The procedures are needed to ensure that the independent certifying organization provide certified individua ls adequate due process.

Appendix A, Part I, item 11 requires that an independent certif ying organization have procedures for proctoring examinations and for ensuring that th e individuals 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 examin ees. The procedures are needed to help ensure fairness in the examination process.

Appendix A, Part I, item 12 requires that independent certifyin g organizations and/or Agreement States exchange information about certified individuals with th e Commission and the Agreement States. This information is needed to ensure that knowledge abo ut certified individuals is shared between the regulatory bodies and the certifying organization.

Appendix A, Part I, item 13 requires that an independent certif ying organization provide a description to the Commission of its procedures for choosing ex amination sites and for providing an appropriate examination environment. The procedures are need ed to ensure that the independent certifying organization provide for appropriate exa mination sites and environments.

16 Appendix A, Part II, item 2 requires that a certification progr am must require applicants for certification to provide documentation that demonstrates that t he 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 an NRC licensee that the applicant has demonstrated the capability of independently working as a radiographer. Submission of this documentation to the certifyin g organization is necessary for the certifying organization to verify an applicant's training a nd to determine that the applicant meets certain certification criteria.

Appendix A, Part II, item 3 requires that a certification progr am must include procedures to ensure that all examination questions are protected from disclo sure. The procedures are intended to ensure that the examinees will not have access to c ertification examination questions.

Appendix A, Part II, item 4 requires that a certification progr am must include procedures whereby an application can be denied, or a certification revoke d, suspended, and reinstated.

The NRC would review an independent certifying organizations p rogram description to ensure that it includes this element. The procedures are intended to e nsure that the certification program include provisions for denying applications, revoking, suspending, and reinstating an individual's certification.

Appendix A, Part II, item 6 requires that a certification progr am must include procedures for renewing the certifications and, if the procedures allow renewa ls without examination, require evidence of recent active full-time employment and annual refre sher training. The procedures are intended to ensure that the certification program include provisions for certification renewal.

Appendix A, Part II, item 7 requires that the certification pro gram provide for timely responses to public enquiries concerning an individual's certification statu s.

Appendix A, Part III, item 3 requires that test items in writte n examinations be drawn from a question bank containing psychometrically valid questions based on the material in § 34.43(g).

17 NRC GUIDANCE DOCUMENTS FOR INDUSTRIAL RADIOGRAPHY

NUREG-1556, Volume 2, Rev. 1, Consolidated Guidance About Mater ials Licenses, Program-Specific Guidance About Industrial Radiograph y Licenses

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