ML20013F819
| ML20013F819 | |
| Person / Time | |
|---|---|
| Issue date: | 03/13/1998 |
| From: | Shelton B NRC |
| To: | |
| References | |
| NUDOCS 9803240287 | |
| Download: ML20013F819 (12) | |
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[7590-01-P]
U. S. NUCLEAR REGULATORY COMMISSION e
Agency Information Collection Activities: Proposed Collection; Comment request AGENCY:
U. S. Nuclear Reguk.iory Coramission (NRC)
" ACTION:
Notice of pending NRC action to submit an information collection request to OMB
- and sclicitation of public comment.
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SUMMARY
- The NRC is preparing a submittal to OMB for review of continueo approval of information collections undel the provisions of the Paperwork Reduction Act of r
1995 (44 U.S.C. Chapter 35).
Information pertaining to fM requirement to be submitted:
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The title of the information collection: 10 CFR Part 21, " Reporting of j
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Defects and Noncompliance" 2.
Current OMB approval number: 3150-0035 3.
How often the collection is required: On occasion 1
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Who is required or asked to report: All directors and responsible officers j
of firms and organizations building, operating, or owning NRC licensed
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I facilities as well as directors and responsible officers of firms and organizations supplying basic components and safety related design, i
analysis, testing, inspection, and consulting services to NRC licensed l
r facilities or activities.
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The number of annual respondents: 100 annually i
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The number of hours needed annually b complete the requirement or i
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request: 17,093 (13,480 reporting hours and 3,613 recordkeeping hours)
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Abstract: 10 CFR Part 21 implements Section 206 of the Energy i
Reorganization Act of 1974, as amended. it requires directors and r
responsible officers of firms and organizations building, operatina owning, or supplying basic components to NRC licensed facilities or activities to
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report defects and noncompliances that could create a substantial safety hazard at NRC licensed facilities or adivities. Organizations subject to 10 CFR Part 21 are also required to maintain such records as may be a
required to assure compliance with @ regulation.
The NRC staff revlaws 10 CFR Part 21 reports to determine whemer the reported defects in basic components ard related services and failures to 5.i t i
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comply at NRC licensed facilities or activities are potentially generic safety proolems.
bubmit, by (irisert date 60 days after publication in the Federal Reoister), comments that address the following questions:
1.
is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information hr /e practical utility?
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Is the burden estimate accurate?
3.
Is there a way to enhance the quality, utility, and clarity of tba information to be collected?
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How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information j
technology?
l A copy of the draf'. supporting statement may be viewed free of charge at the NRC Public Document Room, 2120 L Street, NW (lower level), Washingicn, DC. OM::' clearance requests are availablo at the NRC worldwide web site (http:/Avww.nrc. gov) under the FedWorld collection link on the Some page tool bar. The document veill be available on the NRC home page site for 60 days after the signature date of this notice.
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' domments and questions about the information collection requirements may be directed to the j
NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-6 F33, Washington, DC,20555-0001, or by telephone at 301-415-7233, or by internet electronic mail at l
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BJS1@NRC. GOV.
. Dated at Rockville, Maryland, this[3_
y of Ac h,1998.
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For the Nuclear Regulatory Commission l
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W da 36:(h6 hon 3Retlearance Officer Office of the dhiefanformation Officer 4
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DRAFT SUPPORTING STATEMENT FOR 10 CFR PART 21
" REPORTING OF DEFECTS AND NONCOMPLIANCE" (OMB Olearance No. 3150-0035)
Extension Request with Revised Burden Estimate DESCRIPTION OF THE INFORMATION COLLECTION 10 CFR Part 21.21 requires directors and responsible officers of firms and organizations building, operating, owning, or supplying basic components to NRC licensed facilities, or conducting NRC licensed activities, to report defects in components and failures to comply that could create a substantial safety hazard (SSH).10 CFR 21.51 requires each organization subject to 10 CFR Part 24 to mr.intain such records as may be required to assure compliance
. with 10 CFR Part 21.
A.
JUST!FICATION 1.
Need for and Practical Utility of the Collection of Information Part 21," Reporting of Defects and Noncompliance," implements Section 206 of the Energy Reorganization Act of 1974 (42 U.S.C. 5846). Section 206 requires individual directors and responsible officers of firms constructing, owning, operating, or supplying the basic components of an; facility or activity licensed under the Atomic Energy Act to immediately report to the Commission the discovery of c'efects in basic components or failures to comply that could crea'.; n SSH. In addition to imposing obligations or, the individual directors and responsible officers of NRC !icensees, Section 206 also imposes obligations on the directors and responsible officers of non-licensees that construct facilities for or supply basic ccmponents to licensed facilities or activities. Any individual officer or director who knowingly fails to comply with the notification requirements is subject to civil penalties.
Part 21 contains reporting and recordkeeping requirements which ensure that the NRC is informed of safety defects so that the agency can take appropriate regulatory action. Records are required to be maintained so that technica! 14 sues may be ciectively resolved and for enforceability of the regulations.
p Section 21.7 provides, that the Commission may, upon application of any interested
- person or upon its own initiative, grant exemp;icqs from the requirements of 10 CFR Part 21.
Section 21.21(a) requires the vendor (not an N".C licensee) or licensee to adopt appropriate procedures to; i
' (1). evaluate dev;ations and failures to comply to determine whcther a defect exists
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that could result in a substantial safety hazard Depending upon the outcome of i
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2 the evaluation, a report of the defect must be submitted to NRC as discussed under Section 21.21(d)(1) below.
(2) ensure that if the vendor or licensee cannot complete an evaluation of either the failure to comply or deviation within 60 days of its discovery, an interim written 4
report should be submitted to the Commission describing the deviation or the failure to comply. The report must be submitted within 60 days of discovery of the deviation or the failure to comply.
(3) ensure that a director or responsible officer of a company covered by 10 CFR Part 21 be notified within 5 working days of the determination (based on the evaluation under Section 21.21(a)(1) and (2) above) that a defect or failure to comply associated with an SSH exists.
Section 21.21(b) requires that a vendor that lacks the ability and/or information to perform an evaluation of a deviation transmit information to the purchasers or affected licensees of the basic component within 5 working days of the determination. The purchasers or affected licensees are then expected to evaluate the information as discussed under Section 21.21(a)(1) above.
Section 21.21(d)(1) requires that a director or responsible officer subject to 10 CFR Part 21 or a person designated under 21.21(d)(5) notify the Commission when he or she obtains information reasonably indi:.ating a failure to comply or a defect affecting (1) the construction or cperation of a facility or an activity within the U.S. that is subject to NRC licensing requirements and that is within his or her organization's responsibility; or (ii) a basic component that is within his or her organization's responsibility and is supplied for a facility or an activity with.1 the U.S. that is subject to the NRC lict nsing requirements.
Section 21.21(d)(2) permits the non-reportir.g of defects and failures to comply if the individual director or responsible officer has actual knowledge that the NRC has already been notified.
Section 21.21(d)(3)(l) requires the Commission to be notified by the vendor, licensee or dedicating entity via telephone or facsimile w.inin two days following receipt of information by a director or responsible 6.cer that a defect or failure to comply associated with an SSH exists.
Section 21.21(d)(3)(ii) requires the submittal of a written report by the vendor, licensee or dedicating entity to the Commission within 30 days of identification of a defect or failure to comply associated with an SGH. The report contents are defined in Section 21.21(d)(4).
rection 21.21(e) provides for the Corrmission to obtain from individuais subject to 10 CFR Part 21 any needed additional information related to a defect or failure to comply.
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3 Section 21.51(a)(1) requires vendors, licensees, or dedicating entity to retain records of evaluations of deviations and failures to comply for 5 years after the date of the evaluation.
_i Section 21.51(a)(2) requires vendors of basic components to retain notifications of defects or failures to comply that were sent to purchasers and affected licensees for 5 years after the date of the notification.
Section 21.51(a)(3) requires vendors of basic components to retain a record of purchasers of basic components for 10 years after delivery of the basic component or service associated with a basic component.
2.
Aaency Use of the Information 10 CFR Pad 21 reports are reviewed by the NRC staff to determine whether the reported defects or failures to comply in basic components at NRC licensed facilities or activities are potentially generic safety problems. These reports have been the basis for the issuance of numerous NRC information notices, generic letters and bulletins that have contributed to the improved safet" of the nuclear industry.
s The records required to be maintained in accordance with 10 CFR 21.51 are subject to inspection by the NRC to determine compliance with the subject regulation. These l
records fallinto four categories: records relating to evaluations defined by 10 CFR i
21.3, records.of previously submitted reports pursuant to 10 CFR 21.21, records F procedures required to assure cmpliance with 10 CFR Part 21, and procurement documuits necessary to ensure that background specifications are available to evaluate potential defects and failures to comply.
Industry org9nizations, such as the Institute for Nucl ear Operations (INPO) and the Nuclear Energy Institute (NEI), are urged to share and distribute such information to i
all affected parties as it becomes avaZable. The NRC further disseminates significant generic information to all affected parties via 'IRC infc,rmation notices, generic letters and bulletins, and encourages the eliminatic*
Aplicate reporting. Computer -
databases are used extensively by the NRC anu.ie nuclear industry for tracking these reports.
3.
Reduction of Burden Throuah Information Technoloov There are no legal obstacles to reducing the burden associated with this information j
collection. NRC encouraps the use ofinformation technology.
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Effort to Identify Duolication and Use Similar Information i
l Commission regulations contain several safety deficiency reporting requirements.
Distinctions exist between the: s requirements. Revisions to 10 CFR Part 21 which became effective October 29,1991, clarified the reporting and evaluation requirements to reduce duplication among 10 CFR Part 21,10 CFR Part 50.55(e),10 i
4 CFR Part 50.72,10 CFR Part 50.73 and 10 CFR Part 73.71. See Section 21.21(d)(2) discussion, above.
10 CFR Part 21 implementa Section 206 of the Energy Reorganization Act of 1974, as amended. it is the only regulation that currently requires directors and responsible officers of firms and organizations building, operating, or owning NRC licensed facilities, supplying basic components and services, or conducting NRC licensed activities, tc report defects and failures to comply that could create substantial safety hazards. Similar requirements are not currently available within the NRC or the industry to accomplish the intent of Section 206.
5.
Effort to Reduce Small Business Burden Approximately 10,000 licensees and other organizatiors are under the scope of 10 CFR Part 21. The majority of these respondents are not considered to be small businesses. The revised 10 CFR Part 21, effective October 29,1991, reduced the reporting burden for these licensees and other organizations by eliminating the need for duplicative reporting.
6.
Conse c ces to Federal Prooram or Poiicv Activities if the Collection is Not Conducted or is Conducted Less Frecuently 10 CFR Part 21 has no specific period for reporting; instead, it requires the reporting of defects and failures to comply immediately after it is deternined that they could create a substantial safety hazaro. Imposing greater restrictions to the collection of l
such informa' ion would reduce NRC effectiveness in the area of assessing potentia!!y generic safe!y issues ead in disseminaung such information to affected parties.
7.
Circumstances wKch Justifv Variation from OMB Guidelines 10 CFR Part 21 requires the reporting of defects and failures to comply that could create a substantial safety hazard in facilities or activities licensed by the NRC. This information is needed within two days by telephone or facsimile and 30 days by written report to ensure that the NF.C receives prompt notification of these defects and failures to comply, evaluates them, and is able to promptly disseminate to other licensees information regarding those defects and failures to comply that are determined to be potentially generic safety problems.
In addition,10 CFR Part 21 requires records to be retained beyond the 3-year limit established by OMB. This longer retention is required because review of experience with existing records in recent reviews indicates that a 3-year retention would not be adequate for review and evaluation of recurring defects. It is necessay to be able to verify that the deviation has been adequately evaluated, reported, and corrected as required. Records of evaluations are therefore required to be retained for 5 years.
Supplier notifications to purchasers /affected licensees are retained for 5 years.
Supplier records of the identification of purchasers of basic components are retained for 10 years after delivery of the basic component.
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Consultation Outside the NRC 4
The NRC published a notiu of proposed rulemaking (Federal Register,- October 24, 1994), requesting public comment. This was in response to a petition submitted by_
NUMARC (now NEI) for the purpose of broadening the definition of commercial grade.
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- items that could be dedicated for use in safety-related applications. Such broadening l
would reflect the current marketplace for procurement of basic components, the 2
U results of NRC inspections, and NRC experience with dedication by licensees and i
their agents of commercial grade items for safety-related service. Nearl,v P!!'he l
public comments (18 of 19 let+ers received) supported this change. The final rule
' incorporating the broadened definition cf commercial grad < items was effective in
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October 1995' 4
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Pavment or Gift to R6soondents 9.
Not applicable.
- 10. Confidentiali+v of the Information l
Information that is identified as ; oprietary or confidential, which is defined as information that if disclosed could do substantial harm to an organization's competitive position, would be withheld from disclosure under a Freedorp of
-J Information Act request if the NRC determines that it is in the pubhc interest to withhold it.
- 11. Justification for Sensitive Questions 1This rule does not request sensitive information.
.12. Fatimated Industry Burden and Burden Hour Cost The total burden to respondents, reporting and iecordkeeping in accordance with 10 CFR Part 21 is estimated to be 17.093 hours0.00108 days <br />0.0258 hours <br />1.537698e-4 weeks <br />3.53865e-5 months <br /> based on 90 initie! notifications, 90 written reports,'and 50 interim reports, annually from 100 respondents, or $2,239,183 i
at $131 per hour of professional staff time. Details are included in the attached table.
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- 13. Estimate of Other Additional Costs j
None.
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Estimated Annual Cost to the Federal Govemmutt M'
NRC Burden Table Reports
- Effort
- Total
. Cost ($/yr)
Activity 6ssues/vr)
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(hr/vr)
(85131/hr)
Review Part 21 -
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90 60 5,400-
$707,400 NRC currently reviews reports by issue, not by the type of report (initial, interim, or final information). Thus, though the number of reports received is estimated at 230 per year, NRC reviews are estimated to involve about 90 issues per yrer.:
No applications pursuant to 10 CFR 21.7 are anticipated; thus, no burden is
' estimated.
This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.
- 15.. Reasons for Chanaes in Burden or Cost The total estimated burden to the nuclear industry to undertake Part 21 activities has decreased from 22,913 to 17,093 horidue to an anticipated reduction from 3aC to 180 in the nunnr of Part 21 repnrts filed annually by industry. These anticipated -
changes are based on current experience.
.16. Publication for Statistical Use The data collected through this regulation provide input for generic communications iscued by the NRC steh as information notices, generic letters, and bulletins. Each report received is coded and entered into a computer database system that is used for tracking these reports. The data are not published except as reflected in notices and bulletins.
- 17. Reason for Not Disolavina the Exoiratic Salg The requirement is contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could becom obsolete would be unduly burdensome an( coo difficult to keep current.
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- 18.. Excentions to the Certification Statement
- Not applicable.
Bi-. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL MUTHODS Statistical methods are not used in the collection of information.
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jpdustrv Burden Table Reoortina Reauirement3 i
No. of Reports Effort Total Cost ($/yr)
Section (Annually)
(hr/reot)
(hr/vr)
(@$131/hr) 21.7 0
0 0
0 21.21(a)(2)
(interim report if not resolved in 60 days) 50 95 4,750
$622,250 21.21(d)(1)*
(report of failure to comply or defect) e Initial Notification 90 2
180 23,580 (21.21(d)(3)(l))
e 30-day written follow up (21.21(c)(3)(ii))
90 95 8.550 1,120,000 Total 13,480
$1,765,880 Includes effort for 21.21(a)(1) and (3),21.21(b), and 21.21(e). Reports require two
..Nonses: initial notification by facsimile or telephone with a 30-day written foibwup notification.
Recordkeeoina Reauirements No. of Burden Total Cost ($/yr)
Section Records' (hr/reci~
(hr/vr)
(@$131/hr) 21.51(a)(1)
(retain eval-uations 5 yeat 0 800 3/8 300
$39,300 21.51(a)(2)
(retain noti-fications 5 yrs) 500 3/8 188 24,628 21.51(a)(3)
(retain purchsse records 10 yrs) 25,000 1/8 3,125 409,375 Total 3,613
$473,303 Based on 100 plant-licensees Estimated time required for reviewing, filing, and copying a record
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