ML20249C036

Request for OMB Review & Supporting Statement Re 10CFR21, Reporting of Defects & Noncompliance

ML20249C036
Person / Time
Issue date:	06/17/1998
From:	Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20249C029	List: ML20249C028 ML20249C036
References
OMB-3150-0036, OMB-3150-36, NUDOCS 9806250213
Download: ML20249C036 (9)

Text

_ - _ _ _ _

PAPERWORK REDUCTION ACT SUBMISSION Please rud ths instructions before complzting this form. For additional forms or assistance in s 3pleting this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the a

Supporting Statement, and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget. Docket Library, Room 10102,72517th Street NW, Washington, DC 20503.

1. Agency / Subagency onginating request

2. OMB control numoer U.S. Nuclear Regulatory Commission 7a 3150-0036 b.None

3. Type of information collection (check one)

4. Type of review requested (check one)

a. New collection g

a. Regular

c. Delegated

b. Revision 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 1

d. Reinstatement, without change, of a previously approved substantial number of small entities?

collection for which approval has expired g

b.No

e. Reinstatement, with chan of a previously approved

a. Three years from approval date collection for which approva has expired Requested e@am Me

f. Existing collection in use without an OMB control number

b. Other (Specify):

7. Title 10 CFR 21, Reporting of Defects and Noncompliance

8. Ag ncy form number (s) (if applicable)

Not applicable D l

9. Kaywords Nuclear facilities, Nuclear Reactors, Equipment

10. ADstract 10 CFR21 requires that firms or organizations building, operating, owning, or supplying basic components to NRC licensed facilities regort and keep records of defects and noncompliance that could create a substantial sifety hazard at licensed cilities or to NRC activities.

3

11. Affected public (Marn onmary wtn v amt au otners that nowy wtn *x*)

12. Obligatnon to respond tuera pnmary utn y and an others tnet appiy,.,rn x-)

a. Individuals or households

d. Farms

a. Voluntary T

b. Business or other for-profit

e. Federal Government

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 reporting and recordkeeping cost Durden on tnousanas orconers; 100

a. Total annualized capital /startup costs 0

a. Number of respondents b Total annual responses 230

b. Total annual costs (O&M) 0

1. Percentage of these responses

c. Total ennualized cost requested 0

collected electronically 0.0

d. Current OMB inventory

c. Total annual hours requested 17.093

e. Difference O

d. Current OMB inventory 22,913

f. Explanation of difference e, 06fference (5.820) 9'** #8"98

f. Explanation of differencs

2. Adjustment

1. Program change

2. Adjustment (5.820) k

15. Purpose of information collection

16. Frequency of recordkeeping or reporting lchech allthat apply) g (Mark pnmary with "P' and a# others that apply wrth "X")

7

a. Recordkeeping

b. Third-party disclosure

)

l

a. Application for benefits

e. Program planning or management 7

c. Reporting l

b. Program evaluation

f. Research 7

1. On occasion

2. Weekly

3. Monthly d

~

~

~

~

c. General purpose statistics T

g. Regulatory or compliance

4. Quarterly

5. Semi-annually

6. Annually y

d. Audit

7. Bennially

8. Other (describe)

17. St tistical metnods 18 Agency contact tverson who can best answer questions regarding the Does this information collection employ statistical methods?

Name:

Roberta Ingram 301-415-1219

(

9906250213 900617 Phone:

(

PDR ORO EUSOMB l

PDR

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10/95 f/-M[O v==en nR ev dY M

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O mm en r, av.e.,.,,

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FINAL SUPPORTING STATEMENT FOR 10 CFR PART 21

" REPORTING OF DEFECTS AND NONCOMPLIANCE" (OMB Clearance 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 j

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 j

could create a substantial safety hazard (SSH).10 CFR 21.51 requires each organization subject to 10 CFR Part 21 to maintain such records as may be required to assure compliance with 10 CFR Part 21.

A.

JUSTIFICAT!ON 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 any facility or activity licensed under the Atomic Energy Act to report immediately to the Commission the discovery of defects in basic components or failures to comply that could create an SSH. In addition to imposing obligations on the individual directors and responsible officers of NRC licensees, Section 206 also imposes obligations on the directons and responsible officers of non-licensees that construct facilities for or supply basic components 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 technicalissues may be effectively resolved and to facilitate enforceability of the regulations.

Section 21.7 provides that the Commission may, upon application of any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR Part 21.

C*ction 21.21(a) requires the vendor (not an NRC licensee) or licensee to adopt appropriate procedures to:

(1) evaluate deviations and failures to comply to determine whether a defect exists that couid result in an SSH. Depending upon the outcome of the evaluation, a

e 2

r 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 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 exists.

l 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 of or I

l affected licensees that possess the basic component within 5 working days of the determination. The purchasers or affected licensees are then expected to evaluate l

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 indicating a failure to comply or a defect affecting (i) the construction or operation 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 !s within his or her organization's responsibility and is supplied for a facility or an activity within the U.S. that is subject to NRC licensing requirements.

Section 21.21(d)(2) permits the non-reporting of defects and failures to comply if the individurd director or responsible officer has actual knowledge that the NRC has already been notified.

Section 21.21(d)(3)(i) requires the Commission to be notified by the vendor, licensee or dedicating entity via telephone or facsimile within two days following receipt of information by a director or responsible officer that a defect or failure to comply exists.

Section 21.21(d)(3)(li) 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. The report contents are defined in Section 21.21(d)(4).

Section 21.21(e) provides for the Commission to obtain from individuals subject to 10 CFR Part 21 any needed additional information related to a defect or failure to comply.

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.

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.

Araency Use of the Information 10 CFR Part 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 safety of the nuclear industry.

The records required to be maintained in accordance with 10 CFR 21.51 are subject to inspection by the NRC to determine compliance with th_e subject regulation. These records fallinto four categories: records relating to evaluations defined by 10 CFR 21.3, records of previously submitted reports pursuant to 10 CFR 21.21, records of procedures required to assure compliance with 10 CFR Part 21, and procurement documents necessary to ensure that background specifications are available to evaluate potential defects and failures to comply.

Industry organizations, such as the Institute for Nuclear Operations (INPO) and the Nuclear Energy Institute (NEI), are urged to share and distribute such information to all affected parties as it becomes available. The NRC further disseminates sign;ficant generic information to all affected parties via NRC information notices, generic letters and bulletins, and encourages the elimination of duplicate reporting. Computer databases are used extensively by the NRC and the nuclear industry for tracking these reports.

3.

Reduction of Burden Throua.h Information Technoloav There are no legal obstacles to reducing the burden associated with this information

- collection. NRC encourages the use of information technology.-

L

. 4.

Effort to identify Dun!iration' and Use Similar Information

. Commission regulations contain several safety deficiency reporting requirements.

Distinctions exist between these 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 CFR Part 50.72,10 CFR Part 50.73 and 10 CFR Part 73.71. See Section 21.21(d)(2) discussion, above.

Au _

_im__._____.-i

.l _ i. __ _

4 10 CFR Part 21 implements 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 1

activities, to report defects and failures to comply that could create an SSH. Similar requirements are not currently available within the NRC or the industry to accomplish the intent of Section 208.

5.

Effort to Reduce Small Business Burden Approximately 10,000 licensees and other organizations are under the scope of 10 CFR Part 21. The majority of these respondents are not considered to be small l

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.

Consequences to Federal _Proaram or Poliev Activities if the Collection is Not

. Conducted or is Conducted Less Freauentiv 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 determined that they could create an SSH. Imposing greater restrictions to the collection of such information would reduce NRC effectiveness In the area of assessing potentially generic safety issues and in disseminating such information to affected parties.

7.

Circumstances which Justifv Variation from OMB Guidelines 10 CFR Part 21 requires the reporting of defects and failures to comply that could create an SSH 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 NRC receives prompt notification of these defects and failures to comply, evaluates them, and is able to promptly disseminate to other licensees j

information regarding those defects and failures to comply that are determined to be i

I potentially' generic safety problems.

In addition,10 CFR Psit 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 necessary to be able to l

verify that the deviation has been adequately evaluated, reported, and corrected as 1

required. Records of evaluations are thereforo 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 4

I for 10 years after delivery of the basic component.

I i

ia

.l

o 5

8. ' Consultation Outside the NRC -

Opportunity to comment on the information collection was published in the Federal.

Register on March 20,1998 (63 FR 13703). No comments were received.

9.

Payment or Gift to Respondents Not applicable.

10. Confidentiality of the Information -

Information that is identified as proprietary 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 Freedom of Information Act request if the NRC determines that it is in the public interest to withhold it.

11. Justification for Sensitive Questions This rule does not request sensitive information.

12. Estimated Industnt Burden and Buroen Hour Cost The total burden to respondents for reporting and recordkeeping 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 initial notifications, 90 written reports, and 50 interim reports, annually from 100 respondents, or $2,119,532

- at $124 per hour of professional staff time. Details are included in the attached table.

13. Estimate of Other Additional Cests -

None.

14c Estimated Annual Cost to the Federal Government NRC Burden Table Reports

• Effort.

Total Cost ($/yr)

Activity (issues /vr)

(hr/ issue)

{tirlyI)

(@S124/hr)

Review Part 21 issues 90 60 5,400

$669,600 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.

j at 230 pe.r year, NRC reviews are estimated to involve about 90 issues per year.

1 1

i s

);'

_ _ _ _ _ - _ _ - _ _ _ _ _ - _ - _ _ _ _ _ _ _ = _

4 6

No applications pursuant to 10 CFR 21.7, Exemptions, 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. Bensons for Chanaes in Burden or Cost The estimated burJen to the nuclear industry to undertake Part 21 activities has decreased from 22,913 to 17,093 nours due to an anticipated reduction from S50 to 230 in the number of Part 21 reports filed annually by industry. There is no change in the recordkeeping burden. These anticipated changes are based on current experience.

16. Pub!! cation for Statistical Use The data collected through this regulation provide input for generic communications issued by the NRC sinh as information notices, generic letters, and bulletins. Each report received is codud 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 Exoiration Date The requirement is contained in a regulation. Amending the Code of Federal Regulatioi.* 5 display information that, in an annual publication, could become obsolete would be unduly burdensome and tco difficult to keep current.

.18. Egcentions to the Certification Stefament Not applicable.

B.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Statistical methods are not used in the collection of information.

1 T

f was 4

1

e-Industry Burden Table Reoortina Reauiremgals No. of Reports Effort Total Cost ($/yr)

SAGliDD (Annuallvi (hr/reot)

(hr/vr)

(63124/hr) 21.7 0

0 0

0 21.21(a)(2)

(interim report if not resclved in 60 days) 50 96 4,750

$589,000 21.21(d)(1)*

(report of failure to comply or defect) e Initial Notification 90 2

180 22,320 (21.21(d)(3)(l))

e 30-day written followup (21.21(d)(3)(ii))

90 95 8,550 1,060,200 Total 13,480

$1,671,520 Includes effort for 21.21(a)(1) and (3),21.21(b), and 21.21(e). Reports require two responses: initial notification by facsimile or telephone with a 30-day written followup notification.

Recordkeeoina Requirements No. of Burden Total Cost ($/yr)

Section Records *

(hr/ rect (hr/vri

(@$124/hr) 21.51(a)(1)

(retain eval-uations 5 years) 800 3/8 300

$37,200 21.51(a)(2)

(retain noti-l fications 5 yrs) 500 3/8 188 23,312 21.51(a)(3)

(retain purchase records 10 yrs) 25,000 1/8 3,175 387,500 i

- Total 3,613

$448,012

)

. Based on 100 plant-licensees l

. Estimated time required for reviewing, filing, and copying a record