ML20236J395
| ML20236J395 | |
| Person / Time | |
|---|---|
| Issue date: | 07/06/1998 |
| From: | Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| To: | |
| Shared Package | |
| ML20236J393 | List: |
| References | |
| OMB-3150-0007, OMB-3150-7, NUDOCS 9807080167 | |
| Download: ML20236J395 (21) | |
Text
PAPERWORK REDUCTION ACT SUBMISSION
' Pllese rrd thD instructions befora comp,11 ting this form. For additional forms or assistance in complzting this form, contact your agincy's Papirwork Clasrancs Omcar. Sand two copies of this form, the coll 3ction instrument to be reviewsd, the Supporting Statement, and any additional documentation to: Office of Information and Regulator / Affairs Office of J Management and Budget, Docket Library, Room 10102,72517th Street NW, Washington, DC 20503.
1, Ag;ncy/ Subagency ongtnaung request
- 2. OMB control numeer U.S. Nuclear Regulatory Commission a.
3150-0007
- b. None
- 3. Type of informauon collecton (check one)
- 4. Type of review requesteo (check one)
- a. New collection y
- a. Regular
- c. Delegated y
- b. R2 vision of a currently ' approved collection
- b. Emergency - Approval requested by (date);
- c. Extension of a currently approved collection
- 5. Will this information Collection have a a.Yes significant economic impact on a
- d. Reinstatement, without change. of a previously approved substantal number of small entities?
co!lection for which approval has expired y
b.No
- e. Reinstatement, with change of a previously approved g
- a. Three years from approval date collection for which approval has expired Requested 6' expiration date
- f. Existing collection in use without an OMB control riumber
- b. Other (Specify):
l
- 7. Title l
10 CFR 34, Licenses for Radiography and Radiation Safety Requirement for Radiographic Operations
- 8. Agincy form number (s) (if applicaD/e)
NA
- 9. Keywords Radi tion, Safety, Ind ustrial, Material l
- 10. Abstract
~ 10 CFR 34 establishes radiation safety requirements for the use of radioactive material in industrial
- radiography. The information in the applications, reports, and records is used by the NRC staff to ensure that p blic health and safety is protected, and that licensee possession and use of source and byproduct materialis in c:mpliance with license and regulatory requirements.
11, Aflocted pub llC (Mark ptmary uth *P"and aH omem met syWy um Y)
- 12. Obligallon to respond (Mark pnmary wm "P"and an others that appy uth Y)
- a. Individuals or households
- d. Farms
- a. Voluntary T
- b. Business or other for-profit
~
- s. Federal Govemment
- b. Required to obtain or retain benefits
~
~
- c. Not-for-profit institutions
- f. State, Local or Tribal GovemmentT c. Mandatory
- 13. Annual reporting and recordkeeping hour burden
- 14. Annual reporung and recorokeeping cost burnen (in mousands ordoaarsi 158
- a. Total annual! zed capitai/startup costs 0
- s. Number of respondents l
- b. Totalannualresponses 219
- b. Total annual costs (o&M) 0
- c. Total annualized cost requested 0
l
- 1. Percentage of these responses l
collected electronically 0.0
- d. current OMB inventory o
- c. Total annual hours requested 181,069
- e. Difference 0
- d. Currsnt OMB inventory 151,686 I
g/
- f. Explanation of difference
- e. Difference 29,383
- 1. Program change
- f. Explanation of difference r
- 2. Adjustment
- 1. Program change
- 2. Adjustment '
29,383
/h
- 15. Purpose of informacon collection
- 16. Frequency of recorokeeping or report:ng (Check allthat apply)
- (Most pntnery w@ *P'and a0 others that apply w@ 'X')
]
- a. Recordkeeping
- b. Third-party disclosure
~
~
- e. Program planning or management 7
- c. Reporting
- a. Application for benefits
~
- b. Program evaluation
- f. Research 7 1. On occasion
- 2. Weekly
- 3. Monthly
~
~
- c. General purpose statistics T
- g. Regulatory or compliance
- 4. Quarterly
- d. Audit
- 7. Biennially
~
- 5. Semi-annually
- 6. Annually
- 8. Other (describe) 1 Tyears
~
17, Stausucat methocs
- 18. Agency contact (person who can best answer quescons regeraing the Does this information collection employ statistical methods?
Name:
Frank Cardile
]Yes
, % No 301-415-6185 l
9807000167 900706
$)
Phone:
PDR ORG EUSOMB l-E~~-
M
- o
,on gnaa using inearm.
10/9S
- 19. CIrtific tion far Paperwsrk R: duction Act Submincinna On behalf of this Federal agency,I certify that the collection of information encompassed by this request complies with g
5 CFR 1320.9 '
NOTE: Trie text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8 (b)(3), appear at the end of the instructions. The certification is to be made with reference to those regulatoryprovisions as setforth in the instructions.
. The following is a summary of the topics, regarding the proposed collection ofinformation, that the certification covers:
(a) It is necessary for the proper performance of agency functions; (b) It avoids unnecessary duplication;
- (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous tenninology that is understandable to respondents; (e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; (f) It indicates the retention periods for recordkeeping requirements; (g) ' It informs respondents of the information called for under 5 CFR 1320.8 (b)(3):
(i). Why the information is being collected; (ii) Use ofinformation; (iii) Burden estimate;
- (iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature of extent of confidentiality; and
- (vi) Need to display currently valid OMB control number; (h) It was developed by an office that has planned and allocated resources for the efficient and effective manage-d
- ' "");
(i) liiSes*"effEON*d ekc'I"eSYSNstI8aiSb*y tneiEo"d$ fogy!,*a$l (j) -It makes appropriate use ofinformation technology.
If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in item 18 of the Supporting Statement.
I i:
Signature of Authonzed Agency Omcial Date Date Sgnature of Senior Omcial or designee.
- jy deJo. helton. NR les icer. Omce of the hief information Officer 10/95 OMB 83-1 N'
l l
l SUPPORTING STATEME:NT FOR FINAL 10 CFR PART 34 LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS (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 materialin industrial radiography. The regulations provide for comprehensive and 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 techniq'ue 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 retumed 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 movement and transport of the devices result in unique and continuing potential and actual hazardous radiological conditions.
Section 34.11 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 rev'ew the information submitted on NRC Form 313 to determine whether an applicant 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 informaion with the application:
+
34.13(b) - Schedule and description of training programs for radiographer and radiographer' assistants that meet the requirements of @ 34.43; 34.13(c) - Procedures to verify and document the certification status of the i
l radiographer it employs, including that the certification is valid; u.c
--.__m__________._________________._____...__________._.____,_.a_
2 34.13(d) - Written operating and emergency procedures as described in @ 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 @ 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; J
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, as described in @ 34.42; 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, a description of the procedures to be followed; 34.13.(i) - If the applicant intends to perform their own calibrations, a description of
)
calibration procedures for survey instruments, based on @ 34.25, and a I
description of relevant experience of the person (s) who will perform the calibrations;
)
34.13(j)- An identification of locations of and a description of all field stations and permanent radiographic installations. This requirement has previously been included under " Facilities and Equipment," item 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
@ 34.89; 34.41(c) - For applicants that intend to conduct lay barge, offshore platform, or underwater radiography, procedures describing activities to be performed.
j l
This information is reviewed by the NRC staff to determine whether the training, radiation safety, and internal inspection programs and procedures and the licensee's organizational structure will provide adequate protection of the public health and safety. The NRC review and the findings therefrom form the basis for NRC licensing decisions.
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 previously approved by OMB under clearance number 3150-0120, which should be referred to for information collection burden and supporting data.
Section 34.20(b)(1) requires that each radiographic exposure device have an attached labei bearing information identifying the radionuclides in the device, its activity and the date the activity 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 incorporated in the regulations, in part, in conformance with ANSI Standard N432.
Section 34.25(b) requires that each radiation survey instrument be calibrated at intervals not to exceed six months ad after each instrument servicing, and Section 34.25(c) requires that a
_K
3 record of the calibration be maintained in accordance with @ 34.65. The radiation survey is one l
of the most important aspects of radiation safety and the instruments must be periodically calibrated to assure reasonable accuracy when measuring radiation levels that individuals are exposed to during radiographic operations. The licensee will use the records to assure itself that the instruments available to radiographer 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 leakap' at intervals not to exceed six months, and Section 34.27(c)(2) requires the liccasee to maicin records of leak test results of sealed sources in accordance with @ 34.67 A leak test is the only effective rrethod of determining the integrity of the sealed sources. Serious radiological hazards could result from a leaking sot'rce. The records allow NRC inspectors to verify that required leak tests have been performed.
Section 34.27(cz requires that licensees report within five days results of leak testing which 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 perforrned to verify the condition of the "S" tube.
Section 34.29(ai 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 inver: tory. This information is used by the licensee and NRC to verify that all radioactive materialis accounted for and is properly stored.
S.getion 34.31(a) and (b)(1) cnd (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 l
packaging used to transport radioactive materials. Section 34.31(c) requires the license make a record of any equipment problems and any maintenance performed during the daily visual and operability checks specified in 8 34.31(a), or 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 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 the licensee in keeping
. track of when the equipment was last inspected arid maintained and when the inspection is next due. The recards are used by NRC staff te determine the extent of licensee compliance.
Section 34.33/b) requires that entrance controls and/or the visible and audible a! arms on permanent radiographic installations required by Section 34.33(a) be tested and records of the
't Web
~
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 in'.;tallation is to be used in order to ensure that they are functioning properly is prevent. inadvertent 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 @ 34.75 for three years after it is made, These alarms are an important backup to the radiation survey instrument and are intended to l
prevent inadvertent entry into a radiographic installation (cell) while a source is in the unshielded 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 durable, legible, and clearly vis ble label. This ;equirement 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.
34.35(b)(2,) requires that the licensee not transport licensed material unless the material is packaged, labeled, masked, 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 ir; %rts 34 and 71.
Section 34.43(b)(1) requires the licensee to provide radiographer 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 Pvt 71, the NRC license, and the licensee's operating and emergency procedures. These are needed to ensure that radiographer are sufficiently knowledgeable of applicat,le regulations prior to using licensed material. Section 34.43(c)(1) requires the licensee to provide radiographer' assistants with copies of pertinent sections of Parts 19,20, and 30, and instructions in applicab!e Department of Transportation regulations as referenced in 10 CFR Part 71, and the NRC license under which the assistant will perform radiography, as well as copies of the licensee's operating and emergency procedures.
This is needed to ensure that radiographer' assistants are sufficiently knowledgeable of i
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 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 these individuals are properly trained.
Section 34.45(a) requires that licensees have a program for routine operations and emergencies for employees to follow in performing safety functions. This program, and its associated procedures, is necessary to ensure that individuals handling radioactive material w!!! have guidance in appropriately carrying out safety functions and is to include: (1) safe handling and j
use of sealed sources and radiographic exposure devices, (2) conducting radiation surveys, (3) controlling access to radiographic areas, (4) locking and securing radiographic exposure
~
5 devices, storage containers. and sealed sources; personnel monitoring, (5) transporting sealed soveces, (8) inspection, maintenance, and operability checks of radiographic exposure devices, (7) transport and storage containers, and survey instruments, (8) steps to be taken if a pocket dosimeter reads off-scale, (9) identifying and reportirg def' cts 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 S 34.81 and @ 34.89. These records are necessary to ensure that individuals have current proccdures to use in the conduct of radiographic operations.
Section 34A7(oj requires radiographer to read and record the exposure on their direct reading
.laimeters (pocket dosimeters or electronic personal dosimeters) at the beginning and end of such shift, and that records be maintained for 3 years after the record is made, as spec fi0d 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 electronic personal dosimeters be checked i
at periods not to exceed 12 months for correct response to radiation, and that records shall be maintained for 3 years after the record is made as specified in S 34.83(a). These records are I
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 individuel's pocket dosimeter goes off-scale and that the result of the determination be maintained in accordance with S 34.83(d). This requirement restricts individuals from working with radiation after a j
desimeter discharges, unless any exposure to radiation can be ruled out or the RSO makes a
' determination of the individual's exposure and makes a record of that determination. This i
determination is needed to verify that an individual's dose does not exceed regulatory limits.
Section 34.47(e) requires 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 be included in the records as specified in 6 34.83(d). This requirement is also to ensure that a worker's dose does not exceed regulatory limits.
Section 34AZ@ requires that the licensee maintain reports received from film badge and TLD processois until the license is terminated and that the record be maintained in accordance with S
' 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, sr.d to show compliance with regulatory limits.
t i
j 6
Section 34.47(o) requires that alarm ratemeters be calibrated at periods not to exceed one year i
for correct response to radiation and Section 34.47(c)(4) requires that the licensee must maintain records of the calibrations for 3 ySers after the record is made as speciied in S 34.83(b). This requirement provides a means for the licensees to demonstrate that their alarm ratemeters 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 placing a radiographic exposure device in storage if that survey is the last one performed on the workday, and Section 34.49(d)
J requires these surveys be recorded as spe::ified under S 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 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 l
with regulatory limits.
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 availaNe 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 show3g recc! pts and transfers of sealed sources and devices using depleted uranium (DU) shielding for 3 years after the record is made. The records must include: the date, the individual making the record, the radionuclides, 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.
Srction 34.65 requires that the licensee 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 h::ve been performed. The licensee will use the records to assure itself that the instruments available to radiographer and radiographer' assistants are properly calibrated. In addition, these records are necessary to verify that the licensee is in compliance with NRC requirements as described in S 34.25, and to ensure the safety of the users of these instruments.
Section 34.67 requires that the licensee maintain records of leap test results and that the records be retained for 3 years. These records are necessary to verify that the licensee is in compliance witr. NRC requirements as described in 34.27, and for the licensee to ensure the
~ integrity of the sealed sources / devices in use.
Section 3439 requires that the licensee maintain records of quarterly inventories of sealed sources and devices containing depleted uranium (DU) shielding as specified in S 34.29.
Section 34.69(a) requires that each record be retained for 3 years 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 radionuclides and the number of becquere:s (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 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 allow 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 and 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 dates removed from and returned to storage.
Section 34.71(b.) requires that the licensee retain records of utilization togs 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 has been properly controlled and used.
Section 34.73(a) requires that the licensee maintain records of any equipment problems and any I
maintenance performed under S 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 retained for 3 years after they are made.
Section 34.73(b) states that records of equipment problems and maintenance as required by Sectiun 34.73(a) must include the date of check or inspection, name of inspector, equipment involved, any problems found and what repair and/or mainter ance, if any were done. The records are needed to enable the licensee to keep track of wher the equipment was last inspected and maintained and when inspection is next due. The records cre used by NRC staff to determine tile extent of compliance by the licensee.
Section 34.75 requires that the licensee maintain records of the alarm system and entrance control device tests at permanent radiographic installations as specified under S 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 wete last performed and when they cre next due. The records are also used by NRC inspectors to determine compliance with required testing of important safety equipment.
Section 3QS requires that the licensee maintain records of training of radiographer and radiographer' assistants in accordance with $ 34.43(f). Section 34.79(a) requires that the record includes certification documents, copies of written tests, dates of practical examinations, and names of individuals conducting and receiving the practical examinations. Section 34.79(b) requires that records of refresher safety training and semi-annual inspections for each radiographer and each radiographer 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-annual inspections of each radiographer and radiographer assistant by the RSO or designee, specified in @ 34.43(e), the records must also include a list of the items checked and any non-compliances observed. This is needed to enable licensees to demonstrate compliance with NRC requirements and to keep track of when training is required. The records of the semi-m
-__-___m--_
~
8 annual inspections of job performance will be used by the licensee to ensure that workers are condecting operations in accord with the license. 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 cperating and emergency procedures specified in @ 34.45, until the Commission terminates the license. The records allow the operators to have access to an up-to-date set of written 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 yee s 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 personal direct reading dosimeters or lost or damaged film badges or TLDs until the Comtnission terminates tha 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.
.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 mairitained for 3 years after 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 thre location specified in 9 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 documents and records sufficient to demonstrate compliance at any field stations and each temporary jobsite 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 material is handled. These documents and records include: (1) the license authorizing the use of licensed material; (2) a copy of Pmts 19,20, and 34 of NRC Regulations; (3) utilization records for each radicaraphi:: exposure device dispatched from that location as required by
@ 34.71; (4) records of equipment problems in daily checks of equipment as required by 9 34.73(a); (5) records of alarm system and entrance control checks required by @ 34.75, if applicable; (6) daily pocket dosimeter readings as required by @ 34.47(b); (7) operating and emergency procedures required by 9 34.45; (8) evidence of the latest calibration of the radiation survey instrument in use et the site, as required by @ 34.65; (9) evidence cf the latest calibration of alarm ratemeters and operability checks of pocket dosimeters as required by @ 34.47(c);
j I
9 (10) latest survey records required by 9 34.85; (11) the shipping papers for the transportation of l
radioactive rnaterials 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.
l 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.
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 storing radioactive material in excess of 180 days at any location not listed on the license. These requirements are necessary in order to provide the NRC with information in a timely manner to permit inspection of radioactive material at 'hese 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 pract! cal utility. Appendix A specifies the requirements to be an independent organization and the certification program crite,ria all organizations must address.
Appendix A does not impose requirements on NRC's radiography licensees. Part I of the Appendix provides the requirements to be an independent certifying organization. Parts 11 and lli provide the requirements for the certification program and written examinations for a certifying entity, including the Agreement States. NRC anticipates that certifying ent! ties will maintain their program procedures as long as the organization is identified by NRC as a certifying entity.
i l
For information required under each Part of Appendix A, NRC would review the program description to ensure that it includes the elemerits h that Part.
Accendix A. Part 1. 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 l
are needed to ensure the independent certifying organization has a program in place for monitoring and enforcing its by-laws and policies.-
Accendix A. Part I. item 9 requires that an independent certifying organization have written procedures describing all aspects ofits certification program, maintain records of the current i
status of each individual's _ ratification and the administration of its certification program. The
{
procedures are needed to ensure that the independent certifying organization has an adequate l
certification program. The records are needed by the certifying organization to maintain an I
i
~
10 awareness of each individual's certification, and to record its activities on the admirJstration of its cenikation program. They would review the records during periodic program reviews.
booendix A. Part 1. item 10 requires that an independent certifying organization have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against certified individuals. The procedures are needed to unsure that the independent certifying organization provide certified individuals adequate due process.
Accendix A. Part I. item 11 requires that an independent certifying organization have procedures for proctoring examinations and for ensuring ihat the 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 examinees. The procedures are needed to help ensure faimess in the examination process.
Accendix A. Part 1. item 12 requires that independent certifying organizations and/or Agreement Statea 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.
Acoer dix 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.
Acoerdix A. Part II. iten2 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 ccmpleted 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 documerdation to the certifying organization is necessary for the certifying organization to verify an applicant's training and to determine that the appiicant meets certain certification criteria.
Accendix 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.
Accendix A. Part 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 provisiona vor denying applications, revoking, suspending, and reinstating an individual's certification.
Accendix A. Part !!. item 6 requires that a certification progran' must include procedures for renewing the certifications and, if the procedures allow renewals without examination, require m
,,____o__.___-____.
~
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 11.1 el requires that the certification program provide for timely responses to public enquiries conce;ning 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 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 Throuch information Technoloav There are no legal obstacles to reducing the burden associated with this information collection.
However, because of the types ofinformation, including the need for signature of a responsible individual, and the infrequency of submission, the application form and reports do not lend i
themselves readily to the use of automated information technology for submission.
4.
Effort to identifv Duplication and Use Similar Information The Information Requirements Control Autometed System (IRCAS) was searched to identify duplication. None was found. There is no similarinformation 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 ofimproper handling or use of a radiography source are likely to be the same for large and small er.tities, it is not possible to further reduce the burden on small businesses by less frequent or less complete recordkeeping or reporting.
6.'
Consequences to Federal Procrams or Poliev Activities if the Collection is not Conducted or is Conducted Less Frecuentiv If the information collection was not conducted, or was conducted less frequently, NRC would not have the information needed to assure that licensees are conducting and will continue programs in a manner that will assure adequate protection of the 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 oflicenses are submitted every ten years. Information submitted in previous applications may be referenced without being resubmitted.
l 7.
Circumstances Which Justifv Variation from OMB Guidelines I
L----
r 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 promptly 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 20, 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 badges or RDs until the Commission terminates the !! cense. 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 exposure.
8.
Consultations Outside the NRC An invitation to comment on the information collection requirements in 10 CFR Part 34 was published in the feilal& gists on April 22,1998 (63 FR 19962). There were no comments.
9.
Payment or Gift to Recoondents Not Applicable.
- 10. Confidentiality of Information None, except for proprietary information.
- 11. Sensitive Questions None.
- 12. Estimated Burden and Burden Hour Cost See Tables 1 and 2 for the annualized recordkeeping and reporting burdens and costs for NRC licensees. Total 10 CFR Part 34.,arden 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 $7,294,521.30 ($121/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 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 />.
l
~
13
- 13. Estimate of Other Additional Cost.
Not applicable.
- 14. Estimated Annualized Cost to the Federal Government The estimated annual cost of professional staff effort for activities other than application review is $7,078.50 (58.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> @ $121/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 Parts 170 and 171.
- 15. Reason for Chanae in Burden or Cost The change in burden from the last renewal reflects the addition of Agreement State burden for the first time (+120,783 hrs); the reduction in the number of NRC licensees from 450 to 158, and experience with radiography licensees operating under a revised Part 34 (-91,400 hrs.). The total burden increase is 29,383 hours0.00443 days <br />0.106 hours <br />6.332672e-4 weeks <br />1.457315e-4 months <br />.
- 16. Publication for Statistical Use None.
- 17. Reason for Not Disolavina 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 of Inforrr.ation Emolovirio Statistical Methods Statistical methods are not employed in this collection of information 1
14 TABLE 1 ANNUAL INFORMATION COLLECTION BURDENS ASSOCIATED WITH RECORDKEEPING REQUIREMENTS OF 10 CFR PART 34 1
S:ction No. of Hrs per Total Annual Annual Cost Record Notes Record-Record-Recordkeeping at $121/hr Retention keepers keeper Burden (hr)
Period 34.20(b)(1) 158 0.4 63.20 7,647.20 Labels 34.25(c) 158 0.00 0.00 3 Yrs see
@ 34.65 34.27(c)(2) 158 0.00 0.00 3 Yrs see
@ 34.67 34.27(e) 158 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 see 34.31(c)
@ 34.73 34.33(b) 40 0.00 0.00 see
@ 34.75 34.35(a) 158 0.8 126.40 15,204.40 3 Yrs 34.35(b)(2) 158 36 5,688.00 688,248.00 3 Yrs 34.43(b)(1) &
158 2.5 395.00 47,795.00 34.43 (c)(1) 34.43(f) 158 0.00 0.00 see
@ 34.79 34.45(b) 158 0.00 0.00 RULT see
@ 34.81 SUBTOTAL 6,272.60 758,984.60 h
Note: 1. Retain until license is terminated
l 15 Section No. of Hrs per Total Annual Annual Cost Record Notes Record-Record-Recordkeeping at $121/hr Retention Keepers keeper Burden (hrs)
Period 34.47(b) 158 0.00 0.00 3 Yrs see
@ 34.83(a) 34.47(c) 158 0.00 0.00 3 Yrs see
@ 34.83(a) 34.47(d) 158 0.00 0.00 RULT' see
@ 34.83(d) 34.47(e) 158 0.00 0.00 RULT see
@ 34.83(d) 34.47(g)(4) 158 0.00 0.00 3 Yrs see
@ 34.83(b) 34.49(d) 158 0.00 0,00 3 Yrs see 34.61 158 0.16 25.28 3,058.88
_RULT' 34.63 158 1.6 252.80 30,588.80 3 Yrs 34.65 158 1.6 252.80 30,588.80 3 Yrs 34.67 158 1.2 189.60 22,941.60 3 Yrs 34.69 158 2
316.00 38,236.00 3 Yrs 34.71 158 36 5,688.00 688,248.00 3 Yrs 34.73 158 27 4,266.00 516,186.00 3 Yrs 34.75 40 48.2 1,928.00 233,288.00 3 Yrs some new info 34.79 158 5
790.00 95,590.00 3 Yrs SUBTOTAL 13.708 48 1.658.726.10
16 l
^
S:ction No. of Hrs. per Total annual Annual Cost Record Notes Record-record-recordkeepi g at $121/hr Retention n
keepers keeper burden (hrs)
Period 34.81 158 0.08 12.64 1,529.44 RULT' 34.83(a) 158 122.5 19,355.00 2,341,955.00 3 Yrs 34.83(b) 158 2.5 395.00 47,795.00 3 yrs 34.83(d) 158 3.2 505.60 61,177.60 3 Yrs j
I
]
34.85 158 120 18,960.00 2,294,160.00 3 Yrs 34.89 158 5.4 853.20 103,237.20 RULT Appendix A, 1
10 10.00 1,210.00 life of Part I, item 6 program Appendix A, 1
158 158.00 19,118.00 life of Part I, item 9 program Appendix A, 1
10 10 00 1,210.00 life of Part I, item 10 program Appendix A, 1
10 10.00 1,210.00 life of Part I, item 11 program Appendix A, 1
10 10.00 1,210.00 life of Part I, item 13 program SUBTOTAL 40.279.44 4.873 812.20
' Retain ur:tillicense is terminated.
17 Section No. of Hrs per Total annual Annual cost Record Notes Record-Record-recordkeeping at $121/hr Retention keepers keeper burden (hrs)
Period Appendix A, 158 1
158.00 19,118.00 life of Part 11, item 2 program Appendix A, 1
10 10.00 1,210.00 life of Part 11, item 3 program Appendix A, 1
10 10.00 1,210.00 life of Part II, item 4 program Appendix A, 1
10 10.00 1,210.00 life of Part il, item 6 program j
Appendix A, 200 0.5 100.00 12,100.00 Part 11 it:im 7 TOTALS 60,178.80 7,326,370.90 i
18 TABLE 2 l
ANNUAL INFORMATION COLLECTION BURDENS ASSOCIATED WITH REPORTING REQUIREMENTS OF 10 CFR PART 34 SECTION No. Licensee Hours per Total Annual Cost Report Notes Responses Licensee Annual at $121/hr Retention Annually
Response
Burden (hr)
Period 134.2]d) 1 4
4.00 484.00
, 34.101 (a and b) 5 10 50.00 6,060.00 34.101 (c) 65 0.5 32.50 3,932.50 i Appendix A, Part I, 2
10 20.00 2,420.00 life of it.m 12 program l TOTAL 73 106.50 12,886.50
19 j
TABLE 3 ESTIMATED ANNUAllZED COST TO THE FEDERAL GOVERNMENT I
FOR REVIEW OF REPORTS ASSOCIATED WITH 10 CFR PART 34 I
)
S:ction No. of Fed Govt Staff Hours Annual Federal Government Cost at Licensee Per Response
$121/hr Responses 34.27(d) 1 4
484.00 34.101(a and b) 5 4
2,420.00 l
34.101(c) 65 0.5 3,932.50 Appendix A, Part I, item 12 2
1 24.00 i
TOTAL 73.00 7,078.50 j
l 1
l I
e-
-u
-