ML20127F576
| ML20127F576 | |
| Person / Time | |
|---|---|
| Issue date: | 01/07/1993 |
| From: | Cranford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| To: | |
| References | |
| OMB-3150-0008, OMB-3150-8, NUDOCS 9301200290 | |
| Download: ML20127F576 (15) | |
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% e4 - Request f org >,.0i, NIB p st , Revjew..), _ 91 I important Reaa e" a m wye ccap etrg term Do not use the same SF 83 bena tnree cop 1es Of th's ittm the material to Oe renewed artc 1, 0 N reser w ar L>eatae Orde 12291 reven ano approol under pawnoi-three cop'es o' the supportmg statement. to
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- 2291 : m te PM o and s gn tne reg;atory certifcat.on if en s OH<e of Management end Bucget rec est :s to awe,a! ecer tne Paperwon Re:v: tion Act and 5 CFR Attenton Doc &et Library, Room 3201 1320 s -p M P corv ete Fa-t lo ano s en tne papernon ce t beaten War.h rgion. DC 20503 PART l.-Cr,mplete This Part for All Requests.
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PART lil.-Campbte This Pcrt Gnly if ths Raquisils for Approvst of a Collection of Inform: tion Undst ths Peperwork Reduction Act and 5 CFR 1320.
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" Transportation Safety, Radioactive Materials" 10 CFR Part 71 establishes requirements for packaging, preparation for shipment, and trans-portation of licensed material, and prescribes procedures, standards, and requirements for approval by NRC of packaging and shipping procedures for fissile material and quantities of li c eme d . ma t erl c Lin..exc ess_othpe_A q u a ntitl e s , __ _
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& A e ine 'mp me 25 pnmardy eduCJtional agencies or snatitut,ons Or is tre onmarf pu%e c' t$e cohection related to fede'ai educat?on pfcgrams? C Yes C No
- 6. Dues *N arm use samphng to select respondents or does tre ager:cy recommerto or prescree tne use of sampWg o. statisticai ara' yrs e_,
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Faperwork Certihcabon m se tt eg ths rea aest for OYB apormat, tre ageacf tea;t the semor uti cial or a, aut9 creed representatsve, certifies tnat the requirements of 5 CFR 1300, the hV3cy Ac' stP tt:ca: st3"dFOs or d#cCtries Ed AN Otfer'apDhcatHe mfGrreation pohty QJMtives Pave been comphed eth 5f at te b:Wa* d6c.a! 'Date A
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t c SUPPORTING STATEMENT FOR 10 CFR PART 71 PACKAGING AND TRANSPORTATION OF RADI0 ACTIVE MATERIAL (3150-0008)-
DescriDtion of the Information Collection NRC regulations in 10 CFR Part 71 establish requirements for packaging, preparation for shipment, and transportation of licensed material, and prescribe procedures, standards, and requirements for approval by NRC of packaging and shipping procedures for fissile n..terial and for quantities of licensed material in excess of Type A quantities.
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A. Justification Need for and Aaency Use of the Information Collection Section 71.5 requires that licensees transporting licensed material outside the confines of their plant or other place of use, or delivering licensed material to a carrier for transport, including cases when Department of Transportation (00T) regulations are not applicable, conform-to the standards and requirements of 00T specified in Section 71.5(a), including marking and labeling of packages. Licensees are also required to file with the Commission any requests for modifications, waivers, or exemptions from the requirements of 00T regulations appropriate to the mode of transport.
Section 71.6 afb) requires that an applicant or licensee notify the Commission of information which the licensee recognizes as having significant implications for the public health and safety or the common defense and security. This requirement applies only to information which is not covered by other reporting or updating requirements. The information must be provided within two working days, '
This requirement is necessary because there may be some circumstances in which a licensae possesses _some information which could be important to the protection of public health and safety or the common defense and security but which is not otherwise required to be reported. The codification of this full disclosure requirement should not result in significant additional burdens on applicants or licensees. No formal program is required. What is expected is that licensees will maintain a professional attitude toward safety and that- if some potential safety information is identified by the licensee, the information will be provided freely and promptly to the NRC so that the agency can evaluate it and act on-it if necessary.
Section 71 J % ifies that licensees may submit an application for an exemption from (ne requirements of the regulations contained in 10 CFR Part
- 71. 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 endanger life or property or the common defense and security.
Section 71.12(c)(3) requires that 3rior to a licensee's first use of a package under the general license establisied by this section, the licensee must submit to the NRC the licensee's name and license number, and the package identification number specified in the pack ~ age approval. The information-submitted pursuant to this requirement identifies to the NRC licensing staff the licensees who are using packages approved for use by another l_icensee.
The licensee also comits to comply with the terms and conditions of the specific approval. Unless users are required to register prior to first use of a package, it would not be possible to notify users of changes to the package designs which could affect safety. Knowledge of-the identity of users is also essential to the inspection program. This is a one-time requirement.
Persons need only report if they plan to make use of a particular package design.
Sections 71.31. 71.33. 71.35. and 71.37 s aecify the information required in a license application under Part 71 for eaci proposed packaging design and method of transport. Section 7LE sets forth the general requirenients, including the submission of information specified in sections 71.33 through 71.37 and, in the case of fissile material, an identification of the proposed fissile class. Section 71.33 specifies requirements for package description.
Section 71.35 specifies requirements for package evaluation. Section 71.37 specifies requirements for identification and description of the quality assurance program. The NRC Transportation Licensing staff will review the information submitted with the application to determine whether an applicant's package design, description, evaluation, quality assurance program, and other procedures and programs described in the application are adequate to meet all specified requirements.
Section 71.39 specifies that the Comission may at any time require further information in order to enable it to determine whether a .icense, certificate of compliance, or other approval should be granted, denied, modified, suspended, or revoked. Such additional information is sometimes needed to clarify information submitted in the application, or to rectify deficiencies in proposed or existing programs for protection of the public health and safety and the comon defense and security. The additional information submitted is reviewed by the NRC Transportation Licensing staff to assess the adequacy of the applicant's design, procedures, and other measures for protection of the public health and safety and the comon defense and security and to meet all specified requirements. The NRC review and the findings derived therefrom form the basis for NRC decisions concerning the issuance, modification, or revocation of licenses, certificates of compliance,- or other approval s. -
Section 71.85(c) requires that the licensee mark the packaging with its model number, gross weight, and a package identification number assigned by NRC.
This information is necessary to identify the packaging and provide assurance to others that the packaging meets the requirements of 10 CFR Part 71.
Section 71.87(e) and (f) require that the licensee have written procedures for setting any pressure relief devices on the package and for loading and closing the package. These written procedures are necessary to provide assurance that the package and any pressure relief device provide the proper protection to the licensed material during both normal and accident conditions of transport.
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Section 71 32 requires that prior to delivery of a package to a carrier for transport, the licensee shall assure that any special instructions needed to safely open the package are sent to or have been made available to the consignee.
Section 71.91 requires the licensee to maintain records of each shipment of licensed material not exempt under Section 71.10 for two years and to maintain quality assurance records for the life of the packaging. The licensee must also maintain records of the determinations required by Section 71.85, of monitoring, inspection, and auditing of work performance during design, fabri-cation, assembly, testing, modification, maintenance, and repair of the pack-aging. These records are required to determine whether the licensee's shipping activities are conducted in accordance with the authorization in the license.
Section 71.93fc) requires that the licensee notify NRC at least 45 days prior to fabrication of a package to be used for the shipment of licensed material having a decay heat load in excess of 5 kW or with a maximum normal operating pressure in excess of 103 kilopascal guage. This information is needed to give NRC inspectors the opportunity to verify independently that a package (cask) for the shipment of hazardous quantities of radioactive material (spent nuclear fuel) is constructed in accordance with the approved package design and quality assurance program. Certain vital parts of casks are covered up by other components during fabrication and are not inspectable after the completion of fabrication.
Sgction 71.95 requires that licensees report to the NRC within 30 days any instance in which there is a significant reduction in the effectiveness of any authorized packaging during use, and details of any defect with safety signi-ficance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence. This requirement is needed to provide feedback to NRC concerning the adequacy of approved packages and package approval techniques. This is a one-time requirement. Only those persons who note a substantial reductSn in the effectiveness of an authorized package during use, or a defect with safety significance, are required to "
report under this provision, amounting to only one or two reports a year. The reports are an important part of the program to improve the quality of packaging for licensed radioactive material and the related regulatory review process, and to provide assurance that any defective packages will be removed from use without incident.
Section 71.97 requires each licensee to give advance notification to the governor of a State or the governor's designee for the transport nf certain nuclear wastes to, through, or across the boundary of the state. The notification must be in writing, must contain the name, address, and telephone number of the shipper, carrier, and receiver of the nuclear waste shipment; a description of the nuclear waste, the point of origin of the shipment, the seven-day period during which departure of the shipment is expected to occur, and the seven-day period during which arrival of the shipment at State boundaries is estimated to occur; the destination of the shipment and the seven-day period during which arrival of the shipment is estimated to occur, and a point of contact with a telephone number for current shipment information. Licenseas must also give notice of revisions to schedules and of 3
cancellations of shipments for which notification was given. Licensees are l required to retain a copy of the- notifications and cancellations as a record l for one year. In addition, licensees must keep for one year a record of the name of the individual in the Governor's office who was contacted and informed concerning a revision in shipment schedule information. The records are required in order to permit NRC inspectors to determine compliance with the regulations.
Sections 71.101 throuah 71 R establi;n quality assurance (QA) requirements which apply to all activities affecting the components of packaging which are ,
significant to safety. Sections 71.101 and 71.103 specify licensee responsibility for establishing a QA program. Prior to use of any package for shipment of licensed material, the licence shall file a description of its QA program with NRC and obtain its approva 'he licensee must also notify NRC of its intent to use a previously-approvu wA program. Section 71.103 requires licensees to clearly establish and delineate in writing the authority and duties of persons and organizations performing activities affecting the safety-related functions of structures, systems and components.
Section 71.10E requires the establishment of a QA program, documented by written procedures or instructions. Section 71.107 requires the establishment of written procedures for package design control. Section 71.109 requires-licensees to establish measures to assure that adequate quality is required in procurement documents. It also requires that licensees shall, to the extent necessary, require contractors or subcontractors to provide a QA program consistent with the applicable provisions of Part 71. Etq_ tion 71.111 requires that activities affecting quality shall be prescribed by documented instructions, procedures, or drawings. Section 71.113 requires the establishment of measures to control the issuance of documents, such as instructions, procedures, and drawings, including char.ges thereto, which prescribe all activities affecting quality. Section 71.115 requires the establishment of measures to assure that purchased material, equipment, and services conform to the procurement documents, and requires that such documentary evidence be available prior to installation or use of_the material and equipment. The documentary evidence must be retained by or available to the licensee and must be sufficient to identify the specific requirements met by the purchased material and equipment. Section 71.117 requires the establishment of measures to assure identification and control of materials, parts, and components, either by number on the item or on records traceable to the item. Section 71.112 requires the establishment of measures to assure that special processes, including welding, heat-treating, and non-destructive testing, are controlled and accomplished by qualified personnel using qualified procedures, in accordance with-applicable codes, standards, specifications, criteria, and other special requirements. Section 71.121 requires the establishment of a program for inspection of activities affecting quality, including specification of any necessary mandatory hold points -in appropriate documents. Section 71.123 requires written procedures for a. test-program to demonstrate that the packaging components will perform satisfactorily in' service, and requires that the test results be documented and evaluated. Section 71.125 requires the establishment of measures to assure the proper control, calibration, and adjustment of tools, gages,
! instruments, and other measuring and testing devices. Section 71.127 requires i the establishment of measures to control the handling, storage, shipping, .
l cleaning and preservation of materials and equipment to be used in packaging 4
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in accordance with instructions to prevent damage or deterioration.
Section 71.129 requires establishment of measures to indicate, by the use of markings such as stamps,_ tags, labels, routing cards,- or other suitable means, the status of inspections and tests performed on individual items of-the packaging. Measures- are'also required for indicating the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation. Section 71.131 requires the establishment of doctmented procedures for controlling materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or in.stallation. Section 71.133 requires establishment of measures for documenting the identification, cause, and correction of significant-conditions adverse to quality. Section 71.135 requires that the licensee maintain sufficient records to furnish evidence of activities affecting quality, including design records, records of use and the results of reviews, inspections, tests, audits, monitoring of work performance, and materials analyses, as well as closely related data such as qualifications of personnel, procedures, and equipment. Records must be identifiable and retrievable.
Records pertaining to the fabrication of the package must be retained for the life of the package to which they apply. Records pertaining to the use of the package for shipment of radioactive material mu:t be retained for a period of 2 years after the shipment. Consistent with applicable regulatory requirements, the licensee is required to establish requirements concerning record retention, such as duration, location, and assigned responsibi_lity.
Section 71.137 requires that a comprehensive system of- QA audits be carried out in accordance with written procedures or check lists, and that audit results be documented and reviewed by management.
The purpose of these requirements is to assure that packages are designed, fabricated, tested, procured, used, maintained, repaired, and modified in accordance with the Certificate of Compliance (approval) issued for the package.
Use of Imoroved Information Manacement Techno11gy There are no legal obstacles to reducing the burden associated with this information collection. Applicants-and licensees may use electronic-information processing systems to prepare and submit-required information.
Efforts to Avoid Duplication The Information Requirements Control Automated-System (IRCAS)_was searched to determine duplication. None was found. NRC has adopted a single package approval system (Certificate of Compliance for each package design) and subsequent registration of other users without additional technical data that.
has minimized duplication by licensees and others (DOE, State licensees).
Effort to Use Similar Information There is no similar information available.
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[ffort to Reduce Small Business Burden l in previous years the requirement for each package user to have a copy of the entire safety analysis report for each package was deleted in favor-of a i requirement only to have a copy of the drawings and operating procedures.
This results in a reduced burden for small businesses.
Conseouences of less Freouent Collection Applications for new package certifications are submitted only onca. Other information is collected as dictated by tpecified events. Less frequent collection would impair the ability of NRC to evaluate the adequacy of the l safety of package designs for transport.
Circumstances Which Justify Variation from OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.6(b) Section 71.6a(b) requires that licensees submit-a notification to NRC in less than thirty days from the date of identifying information having significant implications for the public {
health and safety or the common defense and security and which is not covered '
by other reporting requirements. The requirement to provide notification within two working days following the identification of the information~is necessary to ensure-that NRC is made aware of the significant safety infor-matian so as to take prompt effective action to protect the public health and safety. !
Contrary to the OMB guidelines in 5 CFR 1320.6(b), Section 71.95 requires that licensees report to the NRC within 30 days any instance in which there is a significant reduction in the effectiveness of any authorized packaging during use, and details of any defect with safety significance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence. This requirement is needed to provide feedback to NRC concerning the adequacy of approved packages and package. approval techniques. This is a one-time requirement. Only those persons who note a substantial reduction in the effectiveness of an authorized package during use, or a defect with safety significance, are required to report under this-provision, amounting to.only one or two reports a year. The reports are an important part of the program to improve the quality of packaging for licensed radioactive material and the related regulatory review process, and reporting within the prescribed time is needed to provide assurance that any defective packages will be removed from use without incident.
Sections 71.91 and 71.135 require that quality assurance records be retained for the life of the package to which they apply, which period may exceed the 3-year OMB guideline contained in 5 CFR 1320.6(f). These records are needed in o, der to be- able to demonstrate and permit a determination at any-time :
during the life of the package nand 'after any accident involving the package, that the package has been designed, fabricated, tested, procured, used,_ _
maintained, repaired, and modified in accordance with the approved package design and quality assurance program.
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- Consultations Outside the Acency There have been no outside consultations since the previous clearance.-
M surance of Confidentiality None, except for proprietary information, Sensitive Ouestions t
None Publication for Statistical Use None f
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Litjmate of Compliance Bur < ten "
Reportino Reouirementi Licenseel No of Licensee Staff Hours Total Annual Section Responses Annually Per Submittal Licensee Burden (Hrs) 71.5- 2 0.5 .1 71.6a(b) 35 1- 35-71.7 - Included in 71.31 71.12 200 1 200 71.31 100 300 30,000 71.33 - Included in 71.31 71.35 - Included in 71.31 71.37 - Included in 71.31 71.39 20 1,000 20,000 71.85(c) 100 0.5 50 71.89 100 0.17 17 71.93 1 1 1 71.95 2 12 4 48 71.97 100 1 100 71.101 thru 71.137 _10Q 160 16.000-Total 760 66,452 Recordkeepino Reauirements Total Record No. of Annual Hours per Recordkeeping Retention Recordkeepers Re,cordkeeper Hours Period 71.87 - Included-in 71.91 3 yrs 71.91 350 18 6,300 Life of Pkg.
+ 3 yrs 71.97 - Included in 71.91 3 yrs 71.135 - Included in 71.91 Life of Pkg
+ 3 yrs Total Number of Recordkeepers: 350 Total Recordkeeping Hours Annually: 6.300 TOTAL ANNUAL BURDEN (HRS): 72,752 8
-Estimated Cost to Public to Respond Section. Annual Cost to Rescond 71.5 . $123 71.6a(b) $4,305 71.7 - Included in 71.31 71.12 $24,600 71.31 $3,690,000 71.33 - Included in 71.31 71.35 - Included in 71.31 71.37 - Included in 71.31 71.39 $2,460,000 71.85(c) $6,150 71.87(e) & (f) - Included in 71.91 71.89 $2,091 71.91 $774,900 71.93 $123 71.95 $5,904 71.97 $12,300 71.101 thru 71.137 $1,968,000 TOTAL $8,948,496 Source of Burden and Cost Data and Method of Estimatina Burden and Cost This data is based on 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 $123 per hour.
Reason for Chance in Burden There is no change in burden.
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Estimate of Cost to the Federal Government-Annual Cest - NRC Staff Review (Professional effort - 20,800--hours 9 $123/hr) - $2.558.400-Annual Cost - Clerical Processing (Clerical effort - 4,160' hours 0 $60/hr) =$ 249.6M Annual Administrative Costs (Postage, handling, envelopes, etc.) =$ 1.825 Annual Cost for Record Holdings (1,440 cu. ft x $209/cu. ft.) =$ 300.960 Annual Printing Costs -$ 200 Annual Cost for Storage of Forms in NRC Supply
($2.10 per 1,000) =$ 4 Annual ADP Cost =$ 30.0@
Total Annual Cost = $3.140.989 B. Collection of Information Employina Statistical Methods Statistical methods are not used in this collection of information.
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.I-(7590-01) .
l NUCLEAR REGULATORY COMMISSION Documents Containing Reporting or Recordkeeping Requirements: Office of Management and Budget Review AGENCY: Nuclear Regulatory Commission ACTION: Notice of the Office of Management and Budget review of information collection.
SUMMARY
- The Naclear Regulatory Commission (NRC) has recently submitted to tha 3ffice of Management and Budget (0MB) for review the -following proposal for the collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
- 1. Type of submission, new, revision, or extension: Extension.
- 2. The title of the information collection:
10 CFR Part 71 - Packaging and Transportation of Radioactive Material
- 3. Tha form number if applicable: Not applicable.
- 4. How often the collection is required: Applications for package-certification may be made at any time. Required reports are collected and evaluated on a continuing basis as events occur.
- 5. Who will be required or asked to report: All NRC specific licensees ~who-place byproduct, source, or special nuclear material-into transportation, and all persons who wish to apply for NRC approval of package designs for-i use in such transportation.
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.G. An estimate of-the number.of responses: 760
- 7. An estimate of the' total number of hours needed annually to l complete the-
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requirement or request: Approximately 87 hours0.00101 days <br />0.0242 hours <br />1.438492e-4 weeks <br />3.31035e-5 months <br /> per response plus-18 hours per recordkeeper. The total annual industry burden is estimated to be 72,752 hours0.0087 days <br />0.209 hours <br />0.00124 weeks <br />2.86136e-4 months <br />.
- 8. An indication of whether Section 3504(h), Pub. L.'96-511 applies:
Not applicable.
- 9. Abstract: NRC regulations in 10 CFR Part 71 establish requirements for packaging, preparation for shipment, and transportation.of licensed material, and prescribe procedures, standards, and requirements for approval by NRC of packaging and shipping procedures .for fissile material and for quantities of licensed material in excess of Type A quantities.
Copies of the submittal may be inspected or obtained for a fee .from the NRC Public Document Room, 2120 L Street, N.W. (Lower level), Washington, DC.
~ Comments and questions may be directed-by mail to the OMB reviewer:
Ronald Minsk Office of Information.and Regulatory' Affairs (3150-0008) .
NE08-3019 l-Office of Management and Budget L
Washington, DC 20503 l
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3-Comments may also be communicated by telephone at (202) 395-3084.
The NRC. Clearance officer is Brenda Jo. Shelton, (301)'492-8132.
Dated at Bethesda, Maryland, this day of b '
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For the Nuclear Regulatory Commission
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Gerald F. Cranford Designated Senior Official for.Information Resources Management l
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