ML20244B942

Request for OMB Review & Supporting Statement Re 10CFR34, Licenses for Radiography & Radiation Safety Requirements for Radiographic Operations

ML20244B942
Person / Time
Issue date:	06/08/1989
From:	Amenta J NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0007, OMB-3150-7, NUDOCS 8906140059
Download: ML20244B942 (12)

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10 CFR Part 34 - Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations

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

Section 34.3 requires that applications for specific licenses for use of sealed sources in radiography be filed on NRC Form 313, " Application for Material License." Form 313 has been previously cleared under OMB No. 3150-0120, which should be referred to for further supporting information, burden and cost data.

Section 34.11(b) requires applicants to have a trainin, program for radio-graphers and radiographer' assistants, and to submit to the Commission a schedule or description of the program specifying (1) the initial training; (2) periodic training; (3) on the job training; (4) means to be used to determine the radiographer's knowledge and understanding of and ability to comply with Commission regulations and licensing requirements, and the operating and emergency procedures of the applicant; and (5) means to be used te determine the radiographer's assistant's knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant. This information is reviewed by the NRC staff to ensure that radiographer and their assistants will have sufficient training to enable them to work safely and in compliance with NRC regulations, license conditions, and licensee operating and emergency procedures.

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

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

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

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

Section 34.11(d) requires that licensees submit a description of their pro-cedures for inspecting the performance of each radiographer and radiographer's assistant. Section 34.11(d) also requires licensees to conduct internal inspections / audits of the performance of radiographer and radiographer's assistants at intervals not to exceed three months and to retain records of such inspections / audits for three years. The purpose of the inspections / audits is to make management assure itself that personnel are working safely and as required by NRC regulations, license conditions, and licensee operating and emergency procedures. The records of the inspections / audits will be used by the licensee to keep track of deficiencies, if noted, so that they can be corrected. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC staff during inspections to determine whether or not possession and use of the licensed material has been in accordance with NRC regulations and license conditions.

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

Section 34.11(e) requires an applicant to submit a description of its overall organizational structure pertaining to the radiography program, including specified delegations of authority and responsibility for operation of the program. The NRC staff will review this inforrr.ation in order to ensure that the licensee's organization will provide adequate management oversight, supervision and accountability for safe operation of the radiography program and that the lines of authority and responsibility are clear and unambiguous.

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

Section 34.11(f) requires an applicant that desires to conduct its own leak tests to determine possible leakage or contamination from sources used in industrial radiography to provide its specific procedures for performing the tests. The procedures for performing the tests must specify the method of

3-performing the leak' test,,the instrumentation to be used for measurement of the leak test sample, and the experience of the person who will perform the te'ts; s The NRC staff reviews the procedures to ensure that the method of obtaining the leak test sample will be adequate to detercrine if there is any leakage or contamination from the sealed source, that the instrumentation which will be used for measurement is capable of making a quantitative determination of any leakage or contamination, and that the person who will perform the leak tests has training and experience in performing such tests.

The burden and cost associated with this requirement are incurred in connection with the submission of the application, NRC Form 313, referred to under Section 34.3 above, and will therefor be reported under the clearance for that form..

OMB No. 3150-0120, which should be referred to for information collection burden and supporting data.

Proposed Section 34.20(b)(1) requires that each radiographic exposure device

' have an attached label bearing information identifying the radionuclides in the device, its activity, and the manufacturer and model number. This information will serve as a safety notice to users. The label requirement is being incorporated in the regulations in conformance with ANSI Standard N432.

Section 34.24 requires that the licensee maintain sufficient calibrated and operational radiation survey instruments to make physical radiation surveys as required by 10 CFR Parts 34 and 20. It further requires that each radiation survey instrument be calibrated at intervals not to exceed three months and after each instrument servicing and that a record shall be maintained of the results cf each instrument calibration and the date thereof for three years after the-date of calibration. The making of radiation surveys is one of the most important aspects of radiation safety and the instruments e st provide.

reasonable accuracy in the measurement of the levels of radiation.to which individuals are exposed during conduct of radiographic operations. The licensee will use the records to assure itself that calibrated instruments are always available to radiographer and radiographer's assistants. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC staff during periodic inspections to ascertain the instrument calibration history and to determine the extent of compliance with this important aspect of radiation safety.

Section 34.25(c) requires a record of the results of the leak tests of sealed sources required by Section 34.25(b) to be maintained for three years after it is made. 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 regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC staff during periodic inspections to aid in determining the extent of compliance by the licensee.

Section 34.25(d) requires that licensees report within five days of the leak testing any result which would indicate that a source is leaking. Thd 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 licensing staff also uses the report to identify generic problems with regard to source design, f I

4 radiographic equipment design, or problems in source manufacturing and quality control.

Section 34.26 requires that the licensee conduct a quarterly physical inventory of sealed sources received and possessed under a license and maintain records of the inventories for three years from the date of the inventory. The inventories are used by the licensee to maintain control of the location of the sources, and to control the type, quantity and use of byproduct material within the limits authorized by the license. The regulations require that the inventory records be retained for the prescribed period so that they may be reviewed by NRC staff to determine the extent of compliance with authorized possession limits.

Section 34.27 requires that each licensee maintain current utilization logs, which must be kept.available for three years from the date of the recorded event, at the address specified in the license, showing for each sealed source the following information: (a) a description (or make and model) of the radiographic exposure device or storage container in which the sealed source is located; (b) the identity of the radiographer to whom assigned; and (c) the plant or site where used and dates of use. The regulations require that the records be retained for the prescribed period so that they may be used by NRC inspection staff to assist in determining whether the licensed material has been properly controlled and used. The records are also used by the licensee to maintain control of the licensed material.

Section 34.28(b) requires that the licensee conduct a program for inspection and maintenance of radiographic exposure devices, storage containers and source changers at intervals not to exceed three months and maintain records of those

. inspections for three years. Periodic inspections and properly maintained equipment are important to the safe conduct of radiography. The records assist the licensee in keeping track of when the equipment was last inspected and maintained and when inspection is next due. The regulations require that the records be retained for the prescribed period so that they may be used by NRC staff to determine the extent of compliance by the licensee, and to detect problems that may be generic to the equipment so that corrective action might be taken.

Section 34.29(c) requires that the alarms on permanent radiographic installations required by Section 34.29(b) be tested at intervals not to exceed three months or prior to the first use thereafter of the source in the installation and maintain records of tests for three years. These alarms are an important backup to the radiation survey instrument and are intended to prevent inadvertent entry into a radiographic installation (cell) while a source is in the unshielded position. The records are used by the licensee to keep track of when the tests were last performed and when they are next due.

The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC inspectors to determine compliance with required testing of important safety equipment.

Proposed Section 34.30 requires the reporting of radiographic equipment failures that are considered to pose a safety hazard. The information will be {

used by NRC to assess the quality assurance and quality control procedures and practices of device manufacturers. It will also provide a base for analysis of failure rates and lead to improved safety from exposure to the general public

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The information will be reviewed upon receipt to L -and radiography personnel.

l assess'any immediate. health and safety risk involved, so that NRC can initiate immediate action to correct any equipment problem'which poses an unacceptable-health and safety risk.

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

Section 34.32 requires that licensees retain a copy of current operating and emergency procedures as a record until the Commission terminates the license-and requires that, if the procedures are changed, the superseded material be retained.for'three years. The operating and emergency procedures are needed to ensure that the licensee plans for and provides instructions to employees on a number of issues affecting safety. These issues include the safe handling and use of. sealed sources and radiographic exposure devices, conducting radiation surveys, controlling access to radiographic areas, locking and securing sources, devices, and storage containers, personnel monitoring, transporting sources, accident procedures, maintenance of records, inspection and maintenance of devices and containers, defect and noncompliance reports, and immediate steps to be taken if a pocket dosimeter reads off-scale. The procedures are used by the licensee to provide operating and emergency instructions to workers and are reviewed by NRC inspectors to ensure that current instructions are provided.

Section 34.33(b) and (e) Section 34.3(b) requires licensees to make daily records of pocket dosimeter readings. Section 34.33(e) requires that records of daily pocket dosimeter readings shall be kept for three years. Reports received from film badge or TLD processors are to be kept for inspection until the. Commission authorizes their disposal. The records are an important mechanism for controlling exposure to radiation on a day to day basis. They also provide indications of inadvertent exposure or a possible unusual. event.

In addition, they provide a backup record of estimated exposure in the event that a film badge or thermoluminescent dosimeter is lost. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC inspectors to determine licensee compliance with regulations and to determine the effectiveness of the licensee's exposure control program.

Section 34.43(d) requires that a record of a radiation survey be maintained for three years when that survey is the last survey to determine if the source is fully shielded prior to locking the exposure device and ending direct surveillance of the operation. At this time the exposure device is normally being prepared for storage or transport and it is very important that the source be fully shielded. A radiation survey is the most reliable and practical method to make this determination. The regulations require that the records be retained for the prescribed period so that they may be reviewed by NRC inspection staff to determine the extent of compliance with safety requirements by the licensee.

6 Section 34.51 provider that any licensee who wishes an exemption from the requirements of regulations contained-in 10 CFR Part 34 may submit an application. Upon receipt of the application, the NRC may grant an exemption from any particular part of the regulation if it is determined that the exemption is authorized by law and will not result in undue hazard to life and property.

Reduction of Burden Through Information Technology There are no legal obstacles to reducing the burden associated with this information collection. However, because of the types of information and the infrequency of submission, the application form and reports do not lend themselves readily to the use of automated information technology for submission.

Effort Identify Duplication The Information Requirements Control Automated System (IRCAS) was searched to identify duplication. None was found.

Effort to Use Similar Information There is no similar information available to the NRC.

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

Consequences of Less Frequent Collection Applications are only required to be submitted for the initial license, for amendments, and for. renewal every five years. The application process requires that applicants and licensees perform a comprehensive review of their entire-radiation safety program to assure that all activities will be or are being conducted safely and in accordance with NRC regulations. The review and submission of the information required for the application is essential to NRC's determination of whether tne applicant has training, experience, equipment, facilities and procedures for the use of byproduct material that are adequate to protect the public health and safety. Other reporting and recordkeeping requirements are occasioned by specified events such as leak tests, instrument calibrations, and inventories of licensed material. Conduct of these tests and other events and collection of information concerning them at the required frequency is essential to the assurance of protection of the health and safety of workers and the public.

Circumstances Which Justify Variation from OMB Guidelines Section 34.25(d) varies from OMB guidelines in requiring that licensees report within five days of the leak testing any result which would indicate that a

7 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 promptly in order to be able to assess whether corrective actions initiated by the licensee are adequate.

Consultations Outside the Agency There have been no consultations outside the agency since the previous clearance of this information collection requirement.

Assurance of Confidentiality.

None, except for proprietary information.

Sensitive Questions None.

Publication for Statistical Use None.

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8 Estimate of Compliance Burden Reporting Requirements No. of Licensee Staff Hours Total Annual Section Responses Annually Per Submittal Licensee Burden (Hrs) 34.3 - See OMB Clearance No. 3150-0120 34.11(b) - See OMB Clearance No. 3150-0120 34.11(c) - See OMB Clearance No. 3150-0120 34.11(d) - See OMB Clearance No. 3150-0120 34.11(e) - See OMB Clearance No. 3150-0120 34.11(f) - See OMB Clearance No. 3150-0120 34.25(d) 10 0.5 5

[ Proposed 34.30 18 1 18]*

34.51 1 2 2 Total 11 7 Recordkeeping Requirements Total Record No. of Annual Hours per Recordkeeping Retention Recordkeepers Recordkeeper Hours Period 34.11(d) - See OMB Clearance No. 3150-0120 . 3 yrs

[ Proposed 34.20(b)(1) 400 1.5 600 3 years]*

34.24 400 1 400 3 yrs 34.25(c) 400 0.5 200 3 yrs .

34.26 400 1 400 3 yrs 34.27 - 400 3 1,200 3 yrs 34.28(b) 400 4 1,600 3 yrs 34.29(c) 150 0.5 75 3 yrs

• Burden for proposed rule is provided for purpose of this clearance, but is not included in totals. It will be added to inventory when rule becomes final.

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g l Recordkeeping Requirements (cont'd) .

Total Record No. of Annual Hours per Recordkeeping Retention Recordkeepers Recordkeeper Hours Period 34.31(c) 400 1 400 3 yrs 34.32 400 2 800 Duration of License l: 34.33(b) & (e) 400 70 28,000 3 yrs 34.43(c),(d) 400 40 16,000 3 yrs Total Number of Recordkeepers 400 l

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Total Recordkeeping Hours Annually 49,075 TOTAL BURDEN 49,082 hours9.490741e-4 days <br />0.0228 hours <br />1.35582e-4 weeks <br />3.1201e-5 months <br /> Estimated Cost to Public to Respond Section Annual Cost to Respond 34.3 - See OMB Clearance No. 3150-0120 34.11(b) - See OMB Clearance No. 3150-0120 34.11(c) - See OMB Clearance No. 3150-0120 34.11(d) - See OMB Clearance No. 3150-0120 34.11(e) - See OMB Clearance No. 3150-0120 34.11(f) - See OMB Clearance No. 3150-0120

[ Proposed 34.20 $36,000]*

34.24 $24,000 34.25(c) 12,000 34.25(d) 300 34.26 24,000 34.27 72,000 34.28(b) 96,000 34.29(c) 4,500 1

[ Proposed 34.30 1,080]*

• Burden for proposed rule is provided for purpose of this clearance, but is not included in totals. It will be added to inventory when rule becomes final.

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10 Estimated Cost to Public to Respond Section Annual Cost to Respond 34.31(c) 24,000 34.32 48,000 34.33(b) & (e) 1,680,000 34.43(d)- 960,000 34.51 120 TOTAL $2,944,920 Source of Burden and Cost Data and Method of Estimating Data This data is based on previous informal consultations by the staff with a small number of typical licensees and on the number of submittals to NRC in past years. Cost to licensees and applicants is calculated at a rate of $60 per hour.

Reason for Change in Burden The change in burden is an adjustment based on a recalculation in record-keeping burden. This adjustment results from NRC's recent enactment of a rule which adopts a uniform system of record retention periods.

Estimated Annual Cost to the Federal Government The estimated annual cost of professional staff effort for activities other than application review is $180,000 (3,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> @ $60/hr). 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.

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