ML20215N770
| ML20215N770 | |
| Person / Time | |
|---|---|
| Issue date: | 11/05/1986 |
| From: | Norry P NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | |
| References | |
| OMB-3150-0008, OMB-3150-8, NUDOCS 8611070251 | |
| Download: ML20215N770 (11) | |
Text
/W S"""'" ""' 8 3 C._
1'C CMGInL Request for DMB Review
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g gg Imp:rtant Read instructons before cornpletine; form Do not use the same SF 83 Send three copies of this form, the material to be reviewed. and for to r& quest both an Exe<.utive Order 12291 review and approval under paperwork-three copies of the supporting statement, to-the Paperwork Reduction Act Answer all questions in Part 1. If this request is for review under E.O.
Office of Information and Regulatory Af f airs 12291, cornpfete Part 11 and sign the regulatory certification if this.
Office of Management and Budget request is for approva! under the Paperwork Reduction Act and 5 CFR Attention: Docket Library, Room 3201 1320, skip Part 11, complete Part lll and sign the paperwork certification.
Washington, DC 20503 PART 1 -Complete This Part for All Requests.
- 1. Department / agency and Sureau/ office originating request
- 2. Agencycode 1
U.S. Nuclear Regulatory Commission 3 1 5 0 l
l D!ame et person who canTsit ensaer quest.ons regarding this request Telephone number C.E. MacDonald (301 427-4122
- 4. Title of information colintion or ruremaking
~
l 10 CFR Part 71 - Packaging and Transporation of Radioactive Material l
S. t egal au*honty for mformation collection or ru'e (cite Unded State s Coce. Pubhc Law, or Decutive Order) 42 2201(o) uSc
- 6. Affected public(check allthatapply) 5 h Federalagencies or employees
! O ind-dua;s o, nousenoids 3 0 ra,ms e p Non-prof tinstit,ui,ons 2 ll State orlocalgovernments 4 $ Businesses or other for-profit 7 Q Small businesses or organaations PART ll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291
- 7. Regulation identifier Number (RIN)
_ ~~~
_ ___ _. or, None assigned O Dype of submission (check one on each category)
Type of review requested
\\
CLssification Stage of development 10 Standard i O Maior i O eroposed or drari 2
eend,ng 2 O Nonmajor 2 C Fina!orinterim finat.witnpncrrroposal 3 C Emergency 3 0 Final or intenm final, without pnor proposal 4 O Statutoryorjudiciaideadane I. CFR set teon affected CFR
- 10. Does this regulation contam reportmg or recordkeeping requirements that require OMB approval under the Paperwo k Reduction Act and 5 CFR 1320?
. O Yes O No
- 11. If a malcr rule. is there a regulatory imp u.t analys6 attacheo?
1 O ves 2 O No if 'No." did OM8 wa.ve the anews' 3 0 ves 4 0 No C:rtification for Regulatory Submissions in submitting this request for OMU review. tre authortied regulatory contact and the pmgram officeJl Certify that the requirements of E O 12291 and any applicable pohcy directr<cs have been corrphed with Signature o* pregram official
' Cate Signature of authr; reed ragulatoy wrtact 0611070251 l **
- 12. t0M8 use only)
Prmous ed tes t.bso cte 83 108 standard Form 83 (kew 9 8U PGN 1540 00 634 a034 Prescribed by OMB 5 CFR I320and E o 12291
PART lli.-C;mplit2 This Part only if th2 R:;quist is f r Appr:vil cf a C:llicti:n of Information Under the Paperwork Reduction Act and 5 CFR 1320.
I 3 Abstract ~ Describe needs. uses and affected pubhc in 50 words er less
" 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
. licensed _ma.tetial in awa" af type _A_ quanti tie %
- 14. Type of information rotte<. tion (check only one)
Information collections not containedin rules 1 O Regular submission 2 O Emergency submission (cert,Ication attachea)
Information collections contained in rules 3 00 Existing regulation (no change prc,wsed) 6 Fir'ai or entenm final without pnor NPRM
- 7. Enter date of expected or actual Federal 4 0 Notice of proposed rulemaking(FPRM)
A O Regular submission Register publication at this stage of rulemaking 5 0 rinai. NeRM was previousiy pubbsned B O Emersency submission (certshe,t,onattacned)
(month. day. rear >.
- 15. Type of review requested (checA only one) 1 O New coiiection 4 O Reinststement of a previously approved collection for which approval 2 O Revision of a currently approved collection has espired 3 00 Extension of the expiration date of a currently approved collection 5 O Existing collection in use without an oMB control number I
without any change in the substance or in the method of collection L 6. Agency report form number (s)(unclude standard /optronal form number (s))
- 22. Purpose of intormation collection (check as many as apply)
N/A 1 O Asphcation for benerc 2 O erogram evaiuation
- 17. Annual reporting or disclosure burden 3 C General purpose statistics 1 Number of respondents.
4 @ Regulatoryorcomphance 2 Humber of responses per respondent 5 O Program planning or management 3 Total annnal responses (hne I times line 2) 6 C Research 4 Hours per iesponse 7 O Audit 5 Total hours (hne 3 times kne 4)
%*4II
- 18. Annual recordkeeping burden
- 23. Frequency of recordkeeping or reporting (qheck all that apply) 1 Number of recorckeepers 1 @ Recordkeeping 2 Annual hours per recordbeeper.
Reporting 3 Total recordkeeping hours (hne 1 times line 2)
/,UUU 2 R] onoccasion 4 Recordkeeping retention penod 2
years 3 0 weekiy
- 19. Total annual burden.
4 O Montney 5 0 Quartefly 1 Requested (kne 17 5 plus hne 18-3),
- OI 6 0 semi annuatiy 2 In current oMB inventory 0
7 g annu,,iy 3 Difference (Ane 1less Ane2)
Dphnation of difference 8 O B.ennially 4 Program change 9 0 otnertdesenbe>
5 Adjustment.
- 20. Current (most recent) oMB controi number or comment number
- 24. Respondents
- obhgation to comply (checA the strongest obhgation thatapphes) 3150-0008 1 O volunivy
- 21. RIquested empiration date 2 O Required to ebrain or retain a benefit 3 years from approval date 3 Gl Mandatory
- 25. Are the rewondents pnmarily educational agencies or institutions or is the pnmary purpose of the collection related to Federal education programs? O ves Q No
- 26. Does the agency use samphng to select respondents or does the agency recommend or prestnbe the use of samphng or stat stical analysis by rispondents?
. O ves @ No 57.~ Regulatory authority for the information Collection 10 CFR _papt,_71
- or FR
- or. other (specify)
P perwtrk Certification in submittmg this reciuest for oMB approval, the agency head. tre senior official or an authonred representative, certifies that the requirements of 5 CFR 1320. the Pnvacy Act, stat 6tical standards or directives, and any other apphcab'e information pohcy detectives have been Complied with Egnature of prngram official Date Sqnature of agency head. the sen or offecial or an authonzed representative Date Patricia G. Norry, Director 7
j
/b V A,Am y,%y Office of Administratinn 4 CPO : 1984 0 - 453-776
SUPPORTING STATEMENT FOR 10 CFR PART 71 PACKAGING AND TRANSPORTATION OF RADI0 ACTIVE MATERIAL Justification Need for and Agency Use 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 material and for quantities of licensed material in excess of Type A quantities.
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 (D0T) 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 71.7 specifies that licensees may submit an application for an exemption from the 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 prior to a licensee's first use of a package under the general license established by this section, the licensee must submit to the NRC the licensee's name and license number, and the package identifica-tion number specified in the package approval. The information submitted pur-suant to this requirement identifies to the NRC licensing staff the licensees who are using packages approved for use by another licensee. The licensee also commits to comply with the terms and conditions of the specific approval.
Unless users are required to register prior tc 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 in-spection 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 specify the information required in a license application under Part 71 for each proposed packaging design and method of transport. Section 71.31 sets forth the general requirements, 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
2_
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 assur-ance program. The NRC Transportation Licensing staff will review the informa-tion 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 Commission may at any time require further information in order to enable it to determine whether a license, 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 common 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 common defense and
~
security and to meet a'l 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 approvals.
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.
i Section 71.89 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 main-tain 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 tne license.
Section 71.93(c) 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 nonnal 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.
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 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 appro-val techniques. This is a one-time requirement. Only those persons whc 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 provi-sion, 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 gover-nor of a State or the governor's designee for the transport of 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. Licensees must also give notice of revisions to schedules and of cancellations of shipments for which notification was given. Licensees are required to retain a copy of the notifi-cations and cancellations as a record 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 through 71.137 establish 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 responsibi-lity for establishing a QA program.
Prior to use of any package for shipment of licensed material, the licensee shall file a description of its QA program with NRC and obtain its approval. The licensee must also notify NRC of its intent to use a previously-approved QA 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 71.105
4 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. Section 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 changes 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 1
requirements met by the purchased material and equipment. Section 71.117 requires the establishment of measures to assure identification and control of 1
materials, parts, and components, either by number on the item or on records traceable to the item.
Section 71.119 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 the establishment of measures to control the handling, storage, shipping, cleaning and preservation of materials and equipment to be used in packaging 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, j
such as tagging valves and switches, to prevent inadvertent operation.
Section 71.131 requires the establishment of documented procedures for controlling materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation.
Section 71.133 requires establishment of measures for documenting the identi-fication, 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
I
. radioactive material must be retained for a period of 2 years after the shipment. Consistent with applicable regulatory requirements, the licensee is required to establish requirements concerning reccrd retention, such as duration, location, and assigned responsibility. 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 Improved Information Management Technology 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 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 (00E, State licensees).
Effort to Use Similar Information There is no similar information available.
Effort to Reduce Small Business Burden 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 requirement only to have a copy of the drawings and operating procedures. This results in a reduced burden for small businesses.
Consequences of Less Frequent Collection Applications for new package certifications are submitted only once. Other information is collected as dictated by specified events. Less frequent' collection would impair the ability of NRC to evaluate the adequacy of the 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 71.95 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 o' 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 0MB guideline contained in 5 CFR 1320.6(f). These records are needed in order to be able to demonstrate and permit a determination at any time during the life of the package, and 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.
Consultations Outside the Agency There have been no outside consultations since the previous clearance.
Assurance of Confidentiality None, except for proprietary information.
Sensitive Questions None Publication for Statistical Use None
. Estimate of Compliance Burden Reporting Requirements No. of Licensee Staff Hours-
' Total Annual
.Section Responses Annually Per Submittal Licensee Burden (Hrs) 71.5 2
0.5 1
~
-71.7
- Included in 71.31.
71.12 200 1
200 s
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
l' 1
71.95 2
24 48 71.97
-100 1
100 71.101 thru 71.137 100 160 16,000 Total 725 66,417 i
Recordkeeping Requirements Total Record No. of -
Annual Hours per Recordkeeping Retention Recordkeepers Recordkeeper Hours
~ Period 3
71.87
- Included in 71.91 2 yrs 71.91 350 20 7,000 2 yrs &
Life of Pkg
.71.97
- Included in 71.91 1 yr 71.135
- Included in 71.91 2 yrs &
Life of Pkg 350 Total Number of Recordkeepers Total Recordkeeping Hours Annually 7,000 I
TOTAL ANNUAL BURDEN (HRS) 73,417
_.-_,--,.m..-.,
.. Estimated Cost to Public to Respond Section Annual Cost to Respond 71.5
$60 71.7
- Included in 71.21 71.12 12,000 71.31 1,800,000 71.33
-- Included in 71.31 71.35
- Included in 71.31 71.37
- Included in 71.31 71.39 1,200,000 71.85(c) 3,000 71.87(e) & (f)
- Included in 71.91 71.89 1,020 71.91 420,000 71.93 60 71.95 2,880 71.97 6,000 t
71.101 thru 71.137 960,000 TOTAL 4,405,020 Source of Burden and Cost Data and Method of Estimating 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 $60 per hour.
Change in Burden None.
-. -. - ~.-
f
.o
, Estimate of Cost to the Federal Government Annual' Cost - NRC Staff Review (Professional effort - 20,800 hours0.00926 days <br />0.222 hours <br />0.00132 weeks <br />3.044e-4 months <br /> 9 $60/hr)
= $1,248,000~
Annual Cost - Clerical Processing (Clerical effort.- 4,160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> 9 $30/hr)
=$
124,800, Annual Administrative Costs (Postage, handling, envelopes,etc'.)
=$
1,584~
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
=$
30,000 Total Annual Cost
= $1,705,548 1
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