ML20059L020

Forwards 910731 Fr Notice for Amends to 10CFR21 & Subsequent Amends to 10CFR21

ML20059L020
Person / Time
Issue date:	01/27/1994
From:	William Jones NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:	Loeser D MINNESOTA MINING & MANUFACTURING CO. (3M CO.)
References
NUDOCS 9402030055
Download: ML20059L020 (9)

Text

-

T y,,.: e 4

January 27,1994 f

Ms. Deb IAeser 3M Company 3M Center Building 224-2E-06 St. Paul, MN-55144-1000

Dear Ms. Loeser:

< As you requested, I am forw(arding a copy of two different documents.. First is a photocopy of the July 31,1991, Federal Register Notice for the amendments to 10 CFR 21. Second is a copy of subsequent amendments to 10 CFR 21.

If I can be of further assistance, please contact me.

Sincerely, f

William R. Jones.

Reactor Operations Analysis Branch Division of Safety Programs-Office for Analysis and Evaluatio'n of Operational Data

Enclosures:

As stated William R. Jones-Reactor Operations Analysis Branch Division of Safety. Programs 9402030055 940127 office for Analysis and Evaluation PDR ADOCK 04008135 C

'PDR of Operat.ional Data :

Enclosures:

As stated Distribution w/ enclosures:

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'DC15/Centn1 File :

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ROAB.R/F C"'" 5 T;r Distribution w/o enclosures:

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r-a c s.e UNITED STATES NUCLEAR REGULATORY COMMISSION RULES and REGULATIONS 1

TITLE 10. CHAPTER 1. CODE OF FEDERAt. REGULATIONS - ENERGY i

21.3(a) 21.1 PART REPORTING OF DEFECTS AND NONCOMPLIANCE i

21 f

safety hazards or (b) that the facility, and failures to comply under this part Ocurx42. Paortarons

' activity, or basic component supplied and the responsibility of individual Lec.

21.1 Purpose.

to such facility or activity contains de-directors and responsible officers of fects, which could create a substantial auch licensees to report defects under y'4 $P"4 InterpreNons.

O safety hazard, to inunediately notify section 200 of the Energy Reorganization the Commission of such failure to Act of t974.

31.

a 21.s communteauona.

[ comply or such defect, unless he has (c)For persons licensed to operate a 21.6 Postins requirements.

. actual knowledge that the Commission nuclear power plant under part 50 of this 21.7 Exemodons.

has been adequately informed of such chapter. evaluation of potential defects 21.s tcrormselon conection requirements:

OMB spproval defect or is11ure to comply.

and appropriate reporting of defects under ll 50.72,50.73 or 9 73.71 of this Norrrrestion ggy geop,,

ter satisfies each person's

> 21.21 Notifwation of failure to com:4y or

(

eregul ti a in th a p apply, chefuation, notification, and reporting eva existence or a defect and its evaluation.

obligation to report defects under this Paocvaman Docuzms otherwira in parts 31,34,35,39,40,60, part and the responsibility of Individual 21.31 Procurement documents.

61. 70, or art 72 of this chapter, to each uchtc$nsee a

repo ef cts nder Inarsenons. hans e

tl 1 e sed u t to the section 200 of the Energy Reorganization 2#

I" N "'

regulations in this chapter to possess, Act of1974.

2W henance and mWdM use, or transfer within the United States Ewrescarm source matedal, byproduct material, 8 (d) Nothing in these regulations.

8 should be deemed to preclude either an special nuclear material, and/or spent E individual, a manufacturer. or a supplier 21.61 Panure to nottfr.

fuel and high level radioactive waste, or E of acommercialgradeitem(see to construct, manufacture, possess, own, Authodty:Sec. tot.es Stat.ote, as operate or transfer within the United i 21.3(a-1)) not subject to the cmended, sec. 234. 83 Stat,444, as amended States, any production or utilization regulations in this part from reporting to the Commission, a known or suspected -

(42 USC 2201,22a2h secs. 201. as amended, facility or independent spent fuel defect or failure to comply and, as ton, as Stat.1242, as amended.1246 (42 UAC storage installation (ISFSI) or monitored authorized by law, the identity of -

retrievable storage installation (MRS);

Se'c also issued under secs.135.141 and to each director and responsible anyone so reporting will be withheld 8 Pub.t.97-425.96 Stat.2232.2241(42USC officer of such a licensee.%e from disclosure. NRC regional offices

1o155,10161).

regulations in this part apply also to and headquarters will accept collect g

For the purposes of sec. 223. 88 Stat. 9sa. as each individual, corporation, telephone calls from individuals who O emended (12 USC 2273h il 21.8. 21.2ttal wish to speak to NRC representatives cnd 21.31 are issued under sec.181b. sa Stat.

partnership or other entity doing -

concerning nuclear safety-related 948, as amended (42 USC 2201(blh and

, business within the United States, and problems.The location and telephone f each director and responsible officer of iI 2121. 21.41 and 21.41 are loused under sec.

numbers of the five regions (answered such organization, that constructs a Soto,68 Stat. 950, as amanded (42 USC 2201(o11 E production or utilization facility licensed during regular working hours), are listed g for manufacture, construction,or in appendix D to part 20 of this chapter.

operation pursuant to part 50 of this.

The telephone number of the NRC chapter, an ISFSI for the storage of spent Operations Center (answered 24 hou'rs a Or.xt:RAr. PROVISIONS i 21.1 Purpose.

fuellicensed pursuant to part 72 of this -

day-including holidays) is (301) 951- :

The regulations in this part estab-chapter, a MRS for the storage of spent lish procedures and requirementa for fuel or high level radioactive waste

~0550.-

implementation of section 206 of the pursuant to part 72 of this chapter, or a a 21.3 Definitions.

(cologic repository for the disposal ofigh-level radioactive waste und (t)(1) " Basic component." when ap.

Energy Reorganitation Act of 1974.

• As used in this partt That section requires any individual director or responsible officer of a 60 0f this chapter; or supplies basic plied to nuclear power reactors means :

- firtn constructing, owning.. operating comp nents for a facility or activity -

a plant structure, systern, component-O cr supplying the components of any li ensed other than for export.under or part thereof necessary to assure (D O facility or acth*1ty which is licensed or parts 30. 40. 50,60,61. 70. 71. or part 72 of e the integrity of the reactor coolant otherwise regulated pursuant to the s chapkr.

A pressure boundary, (11) the capaht11ty a

,1 Atomic Energy Act of 1954, as ameno.

(b) For persons licensed to construct a an to shut down the reactor and maintain

• ed, or the Energy Reorganization Act facility under a construction perrait E lt in a safe shutdown condition. or (111)

I of 19'l4, who obtains information rea, Issued under i 50.23 of this chapter, t; the capability to prevent or mitigate sonably indicating: (a) That the facilj.

evaluation of potential defects and the consequences of accidents whleh

'.y. activity or basic component sup.

failures to comply and reporting of could result in potential offsite expo.

plied to such fac!Uty or activity fails to defects and failures to comply under sures comparable to those referred to comply with the Atomic Energy Act of 150.55(e) of this chapter satisfies each in i 100.11 of this chapter.

1954, as amended. or any appilcable Tule, regulation, order, or license of person s evaluation. notification. and (2)" Basic component.* when app!!cd the Commte.slon relating to substantial reporting obligation to report defects to other facilities and when applied to i

e.dv 11 10Q1 w

y

a 2Wc) 2:aa)

PART 21

• REPORTING OF DEFECTS AND NONCOMPLIANCE s

other activities licensed pursuant to (2) The installation, use, or oper-(m) " Substantial safety hazard" means g 1

Parts 30,40,50,60,61,70. 71, or 'l2 of ation of a basic component containing a loss of safety function to the extent 4.'

. this chapter, means a component, a def ect as defined in paragraph (d)(1) that there is a major reduction In the O ' structure, system, or part thereof that of this section; or degree of protection provided to public

% is directly procured by the licensee of (3) A deviation in a portion of a fa-health and safety for any facility or

[ a facility or activity subject to the reg.

cility subject to the construction activity licepsed, other than for export, ulations in this part and in which a permit or manufacturing licensing re-g ursuant to Parts 33,40,50, N1, 61*

A p

defect (see. I 21.3(d)) or failure to comply with a.ny applicable regulation quirements of Part 50 of this chapter g 7Q,71.or 72 of this chapter, in this chapter, order, or license issued provided the deviation could, on the cc basis of an evaluation, create a sub- $

by the Commi"lon could create a sub.

stantial safety hazard and the portion a

stantial safety hazard (see i 21.3(k)).

of the facility containing the devlation 2

has been offered to the purchaser for (n) " Supplying" or ** supplies" means

> (3)1n all cases. basic compoAent contractually responsible for a basic

. includes safety related design, analysis, g acceptance;or component used or to be used in a fie

' 8 replacement parts.orsonsulting E (4) A condition or circumstance in.

c!11ty or activity which is subject to 8 inspection, testing, fabrication, a

- volving a basic component that could the regulations in this part..

E services that are associated with the contribute to the exceeding of a safety

~

g component hardware whether these limit, as defined in the technical speci-services are performed by the fications of a.IIcense for operation component supplier or others, issued pursuant to Part 50 of this g 21.4 Interpretations.

Except as soecifically authorized by g"e beviation" means a departure -

from the technical requirements in g me Cmnmission in wWng, no (4) A commercialgrade item is not a part of a besic component until after dedication (see 121.3(o-1)).

cluded in a procurement document lations in this part by any officer or-g (see i 21.3(1)).

D (f) " Director" means an indiv! dual, I h*gn bep n by (3-1)

• Commercial grade item" means mi c3 item that is (1) not subject to design appointed or elected according to law, General Counsel will be recoginized to cr specification requirements that are who is authorized to manage and be binding upon the Commluton.

unique to facilities er activities licensed direct the affairs of a corporation, 7 pursuant to Parts 30,40,50,00,61,70,71, or partnership or other entity. In the f, 72 of this chapter and(2) used la case of an individual proprietorship, p_

cpplications other then facilities or director' means the individual.

> $ 21.5 Cv...a.:; W,.e.

. c' h acth%esIIcensed pursuant to Parts 30, Except where otherwise specified in 40,50,60,a1,70.71 or72 of this chapter this part, all written communications

(

and (3) to be ordered from the

> (g) Discovery means the completion of and reports concerning the regulations minufacturer/ supplier on the basis of.

the documentation first identifying the lin this part must be addressed to the specifications set forth in the existence of a deviation or failure to

,, Document Control Desk, U.S. Nuclear m:nufscturer*a published product comply potentially associated with a description (for example a catalog).

substantial safety hazard within the g Regulatory Commission. Washington.

e DC 20555.In the case of a licensee, a evaluation procedures discussed in

• copy must also be sent to the

~

I 21.21. (a).

appropriate Regional Administrator at (b) " Commission" means the Nucle-the address specified in appendix D to E ar Regulatory Comtnission or its duly (h) Evoluotion means the process of part 20 of this chapter.

L authorized representatives.

determining whether a particular 1

deviation could create a substantial I II g 21.6 Posting requirementa. '

m an e ad n.

c p s as oci d th a (a) Each individual, partnership, cor-m:nufacture, fabrication, placement, substantial safety hazard.

poration or other entity subject to the 8 crection, installation, modification, ot!ficofion means the telephonic regulations in this part, shal; post cur.

- 1 N inspection, or testing of a facility or e mmunication to the NRC Operations rent copies of the following documents E sctivity which is subject to the lis Center or wrinen transmittal of in a conspicuous position on any prem-j regulations in this part and consulting h ini unadon to the NRC Document Ises, within the United States wh.ere services related to the facility or activity u ControlDesk.

the activities subject to this part are thst are safety related.

$ 0) Operating or operation means the conducted (1) the regulations in this -

I part,(2)Section 206 of the Energy Re-operation of a facility or the conduct of

- organization Act of 1974, and (3) pro-a licensed activity which is subject to cedurcs adopted pursuant to the regu-

~U the regulations in this part and

lations in this part.

(c-1)

• Dedication" of a commercial consulting services related to operations (b) If posting of the regulations in g

8

• grade item occurs after receipt when that are safety related-I this part or the procedures adopted that item is designated for use as a pursuant to the regulations in.this a

basic component.

(k) " Procurement document" means part is not practicable, the licensee or

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a contract that defines the require-firm subject to the regulations in this ments which facilities or basic compo-part may, in addition to posting sec-nents rnust meet in order to be consid.

tion 206, post a notice which describes (d) " Defect" means' ered acceptable by the purchaser.

the regulations / procedures, including-

.i

basic component delivered to a pur-01 " Responsible officer" means the the name of the individual to whor l

(1) A deviation (see i 21.3(e)) in a chaser for use in a facility or an acthi-president, vice-president or other indl.

reports may be made, and states whet vidual in the organization of a corpo-they may be examined.

-a

[. ty subject to the regulations in this ration, partnership, or other entity (c)The effective date of this section part if, on the basis of an evaluation

'.(see 121.3( g D. the deviation could who is vested with executive authority has been deferred until January 6, create a substantia.1 safety hazard; or over activities subject to this part.

1978.

21.21(d)

PART 21 e REPORTING OF DEFECTS AND NONCOMPLIANCE g 21.7 Es emptions.

(3) Ensure that a director or has been received should be made by The Commission may, upon appI!ca.

responsible officer subject to the calling the NRC Operations Center.This regulations of this part is informed as paragraph does not apply to interim 5 tion of any interested person or upon E lts own initiative, LTant such exemp.

soon as practicable, and, in all cases, reports described in i 21.21(a 2).

[ tions from the requirements of the within the 5 working days after (ii) Written notification to t e NRC at regulations in this part as it deter.

completion of the evaluation described the address specified in 5 21.5 witidn 30 mines are authorized by law and will in i 21.21(a)(1) or i 21.21(a)(2) if the days following receipt ofinformation by not endanger life or property or the construction or operation of a facility or the director or responsible corporate common defense and 1,ecurity and are activity, or a basic component supplied officer under patagraph (a)(3) of this otherwise in the public interest-for such facility or activity-section, on the identification of a defect (i) Falls to comply with the Atomic or a failure to comply.

Energy Act of 1954, as amended, or any g

[

Sup.

applicable rule. regulation. order, or this paragraph shall include, but need

pliers of commercial grade items are license of the Commission relating to a not be limited to, the following infor.

E exempt from the provtsions of this substantial safety hazard, or mation, to the extent knowrr part to the extent that they supply A

commercial grade items.

(ii) Contains a defect.

(1) Name and address of the individu.

(b)If the deviation or failure t al or individuals informing the Com-comply is discovered by a suppher of missim basic components, or services (11) Identification of the facility, the i 2u Wmm WW associated with basic components, and activity, or the basic component sup-m, ppm,g, the suppher determines that it does not plied for such facility or such activity (a)The Nuclear Regulatoy have the capability to perform the within the United States which falls to Commission has submitted 'he evaluation to determine if a defect comply or contains a defect.

information collection re[utrementsexists, then the suppber must inform the (111) Identification of the firm con-contained in this part to e Office of purchasers or affected licensees within structing the facility or supplying the Management and Dudget (OMB) for five working days of this determination basic component which falls to comply approval as required by the Paperwock so that the purchasers or affected or contains a defect.

g Reduction Act of1900 (44 U.S.C. 3501 et licensees may evaluate the deviation or (iv) Nature of the defect or failure to a; seg ).OMB has approved the failure to comply, pursuant to i 21.21(a).

comply and the safety hazard which is created or could be created by such information collection requirements (c)(1) A director or responsible officer e

defect or failure to comply.

cP2tained in this part under control subject to the regulations of this part or (v) The date on which the informa.

number 3150-0035.

a person designated under i 21.21(c)(5)

(b)'!he appmved information must notify the Commission when he or g t. ion of such defect or failure to com I w o collection requirements contained in this she obtains information reasonably g g indicating a failure to comply or a defect

$ which contains a defect or ialls to part appear in ii 2L21 and 21.5L g

comply, the number and location of all

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construction or operation of a such components in use at, supplied facilitI or an aCliVitY within the United for, or being supplied for one or more NonncAUoM Ec u.

> $ 21.21 Houfication of fanure to compfy or 3

ates ist is subject to the licensing facilities or activities subject to the r-.

requirements under parts 30,40,50,00, regulations in this part.

exletence of a defect and its evaluation.

h p a that (a) Each individual, corporation.

fs h 'hfs o (v )

e correctiv act n ch eg partnership, or other entity subject to responsibility; or name of the individual or organization (ii) A basic component that is within responsible for the action; and the the regulations in this part must adopt appropriate procedures to-his or her organization's responsibility length of time that has been or will be (1) Evaluate deviations and failures to and is supplied for a facility or an taken to complete the action.

comply to identify defects and failures activity within the United States that is (vill) Any advice related to the to comply associated with substantial subject to the licensing requirements defeet or failure to comply about the safety hazards as soon as practicable, under parts 30, 40,50,00,61. 70,71, or 72 iacility, activity, or basic component and, except as provided in paragraph of this chapter.

that has been is belng, or will be given (a)(2) of this section,in all cases within (2)The notification to NRC of a failure to purchasers or licensees.

60 days of discovery,in order to identify to comply or of a defect under

- (5) The director or responsible offi-a reportable defect or failure to comply paragraph (c)(1) of this section and the cer may authorize an individual to that could create a substantial safety evaluation of a failure to comply or a provide the notification required by

_ hazard, were it to remain uncorrected, defect under paragraphs (a)(1) and (a)(2) this paragraph, provided that, this 8 and of this section, are not required if the shall not relieve the director or re-M (2) Ensure thatif an evaluation of an director or responsible officer has actual sponsible officer of his or her responst-

{

E identified deviation or failure to comply knowledge that the Commission has bility under this paragraph.

potentially associated with a substantial been r atified in writing of the defect or (d) Individuals subject to this part 1

safety hazard cannot be completed the failure to comply.

may be required by the Commission to e*

within 60 days from discovery of the (3) Notification required by paragraph supply additionalinformation related to j

deviation or failure to comply, an (c)(1) of this section must be made as a defect or failure to comply.

i interim report is prepared and submitted follows-Commission action to obtain additmn.d to the Commission through a director or (i) Initial notification by facsimile.

information may be based on reports of responsible officer or designated person which is the preferred method of defects from other reportmx entitm-as discussed in i 21.21(c)[5). The interim notification, to the NRC Operations report should describe the deviation or Center at 301-49241187 or by telephone fadure to comply that is being evaluated at 301-951-0550 within two days and should also state when the following receipt ofinformation by the evaluation will be completed.This director or responsible corporate offner interim report must be submitted in under paragraph (altt) of this section, on writing within 60 days of discovery of the identification of a defed or a fadure the deviation or failure to comply.

to comply. Verification that the fermic H9 Jufv 31 1991 f

21R PART 21

• REPORTING OF DEFECTS AND NONCOMPLIANCE

/

Euroscrmr.wr

(

)

PROcURDEENT DOCUMDrTs

$ 21.31 procurement documents.

Each individual, corporation, parte J

pership or other entity subject to the '52 tat Fauurs to noufy.

regulations in this part shall assure Any director or responsible cmcer th_t each procurement document for a 4 subject to the regulations in this part facility, or a basic component issued E who knowingly and consciously fails to by him, her or it on or after January O provide the notice required by i 21.21 O 6,1978 specifles, when applicable, that f shallbe subject to a civil penalty equal the provisions of 10 CPR Part il to the amount provided by section 234 of E *DPIY-7 the Atomicf.nergy Act of1954, as -

InstscTtons, Raccans

• f 21.41 Inspections.

amended.

Each individual, corporation, part-y pership or other entity. subject to the regulations in this part shall permit

{N te tem ved 49 FR 19623) duly authorized representatives of the Commtanton, to inspect its records, premises, activities, and basic compo-nents as necessary to effectuate the purposes of this part.

1

' f~

- p $ 21.51 namintenance and Inspection of

records,

'I (a) Each individual, corporation, 1

partnership, or other entity subject to the regulations in this part must prepare c.nd maintain records necessary to tecomplish the purposes of this part, 1

specifically-(1) Retain evaluations of all -

deviations and failures to comply for a

~

minimum of five years after the date of the evaluation: -

(2) Suppliers of basic components must retain any notifications sent to purchasers and affected licensees for a minimum of five years after the date of

the notification.

l g(3) Suppliers of basic componentsa. must retain a record of the purchasers of

' basic components for to years after j

G delivery of the basic component or service associated with a basic component.

(b) Each individual, corporation, partnership, or other entity subject to the regulations in this part must afford the Commission, at all reasonable times.

the opportunity to inspect records pertaining to basic components that relate to the discovery, evaluation, and reporting of deviations, failures to comply and defects, including ny advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component -

a

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UNITED STATES NUCLEAR REGULATORY COMMISSION HUI ES and REGULATIONS TITLE 10. CHAPTER 1. CODE OF TEDERAL REGUt.ATIONS - ENERGY 21.3(a) 21.1 PART REPORTING OF DEFECTS AND NONCOMPLIANCE G amas. Pmovisions safety hazards or tb) that the facility, and failures to comply under this part in activity, or basic component supplied and the responsibility ofindividual 21.1 Purpose.

to such facility or activity contains de-directors and responsible officers of y Q"jg

fects, which could create a substa.ntial such licensees to report defects under 21.4 Interpretathons, safety hazard, to immediately notify section 200 of the Energy Reorganization a the Commission of such iallure - to Act of 1974.

22.5 communications.

I, comply or such defect, unless he has (c) For persone licensed to operate a 21.6 Postins requirements.

actual knowledge that the Commission nuclear power plant under part 50 of this 21/2 Exemr3tions.

2t Information conect,on sequiremenn has been adequately informed of such chapter. evaluation of potential defects i

M u sppront.

defect or failure to comply.

and appropriate reporting of defects NoTwicatro"

~

under il 50.72. 50.73 or i 73.71,of this gy e,p,,

che ter satisfies cach person's 21.21 Notifiention of failure to comply or (a)The regulatio s in this p tt apply, eva ustion, notification, and reporting cdstence of s defect and its evaluation.

oM adon to report defects under this 8

Pm mammt Docpars otherwise in parts 31. 34,35,39. 40. 00 part and the responsibility of individual -

21.21 l'rocurement documents.

61.70.or art 72 of this chapter, to each directors and responsible officers of individua. partnership, corporation, or such licensees to report defects under Instrcrsons. Rrcoans other entity licensed pursuant to the secHon 200 of the Energy Reorganization 2iAl Inspections.

regulations in this chapter to possess' s Act of 1974.

use, or transfer within the United State Enroaccu mT source material, byproduct material.

'8 (d) Nothing In these regulations j

21.61 Failure to notify.

special nuclear material, and/or spent

$ should be deemed to preclude either an 1

p2162 Oiminal pend,cs fuel and high level radianctive waste, or

6. Individual, a manufacturer, or a suppher to construct,inanufactur e, possess, own.

E of a commercialgradeitem(see l

operate or trester withm the United i 21.3(n-1)) not subject to the l

States, any proo#bn or utilization regulations in this part from reporting to facuity or independent spent fuel the Commission, a known or suspected

> Authority: sec. ut, sa stat. 94a. as storage installation llSFSI) or monitored defect or failure to comply and, as amended, sec. 234. 83 Stat. 444, en amended tw 14211.S C 2201. 2282). secs. 20s as amended, retrievable storage installation (MRS);

authorized by law, the identity of

{ zon, as stat 1242. as emended 1240142 tLSc and to each director and responsible anyone so reporting will be withheld

.o satt,5840).

officer of such a licensee. The from disclosure. NRC regional offices

& Section 212 also issued under secs.135.

regulations in this part apply also to and headquetters will accept co!!ect g 141. Pub. L 97-425. 96 stet. 2232. 2241 (42 each individual corporation, telephone calls from individuals who partnership or other entity doing wish to speak to NRC representatives L.sCsoiss.soteil.

U business within the United States, and concerning nuclear safety-related 8 each director and responsible officer of problems. The location and telephone 8 such organization that constructs a numbers of the five regions (answered E production or utilization facility licensed during regular working hours). are listed e for manufacture, construction, or in appendix D to part 20 of this chapter.

G U ERAT. PRoVIStops operation pursuant to part 50 of this The telephone number of the NRC.

chapter, an ISFSI for the storage of spent Operations Center (answered 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a i fu Nepee, fuellicensed pursuant to part 72 of this day-including holidays) is (301) 951-The regulations in this part est.ab-chapter, a MRS for the storage of spent lish procedures and requirements for fuel or high level radioactive wesie

~0550.

implernentation of section 206 of the pursuant to part 72 of this chapter, or a 3 21J Definitions.

Energy Reorganization Act. of 1974 1

I h P'If Ths.t section requires any individual fh le i di iv as e under Eart (aM1) Basic component, when ap-J 8

director or responsible officer of a 80 of this chapter; or supplies basic plied to nuclear power reactors means firrn constructing, owning, operating 3 or supplying the components of any components for a facility or activity a plant structure system, component

% faellity or activity which is lleensed or licensed, other than for export. under or part thereof necessary to assure (1) parts 30,40. 50,60. 61. 70. 71. or part 72 of e the integrity of the reactor coolant

[ otherwise. regulated pursuant to the this chapter, d pressure boundary. (ID the capability Momic Energy Act of 1954 as amend-(b) F r persons licensed to construct a a to shut down the reactor and maintain

)

a ed. or ihe Energy Reorganization Act facility under a construction permit E lt in a safe shutdown condition or (110 -

of 1974, who obtains information rea-sonably Indicating: (a) That the faelli.

Issued under ! $0.23 of this chapter.

t; the capability to prevent or Initigate ty. activity or basic component sup.

evaluation of potential defects and the consequences of accidents which plied in such f acility or activity falls to failures to comply and reporting of could result. In potential offsiterpo.

comply with the Atomic Energy Act of defects and failures to comply under sures comparable to those referred to 1954 as amended, or any applicable i 50.55(e) of this chapter satisfies each in i 100.11 of this chapter, rule, regulation, order or license of person's evaluation notification, and (2) **Dasic component.** when app!!cd the Commlulon relating to substantial reporting obligation to report defects to other f acilities and when applied to November 30,1992 m

p M C) 2 W a)

PART 21 e REPORTING OF DEFECTS AND NONCOMPUANCE (m)

• Substantial safety hazarf* means other activities licensed pursuant to (2) The installation, use, or oper-a loss of safety function to the extent Parts 30, 40, 50, 60, 61, 70, 71, or 72 of ation of a basic component containing that there is a major reduction la the this chapter, means a component, a defect as defined in paragraph (d)(1) degree of protection provided to public I structure, system, or part thereof that of this section; or Z is directly procured by the licensee of (3) A deviation in a portion of a fa-health and safety for any facility or g! activity licepsed. other than for export.

[ a f acility or activity subject to the reg.

c!11ty subject to the construction ulations in this part and in which a permit or manufacturing licensing re-pursua nt to Parts 30,40, M 00, 61

• k gulrements of Part 50 of this chapter g7 delcet (see i 21.3(d)) or failure to gP j

comply with any applicable regulation provided the dev!ation could, on the e

i in this chapter, order, or license issued basis of an evaluation, create a sub- 0; j

.by t.he Commission could create a sub.

stantial safety h 2.ard and the portion i

stantial saf ety hazard (ace i 21.3(k H.

of the facility containing the deviation has been offered to the purchaser far (n) " Supplying" or "supp!!cs" means J

(3)ln all cases, hosic componen*

contractually responsible for a basic includes safety related design, analysis.

g acceptance; or component tased or to be used in a fa.

)

cility or activity which is subject to a

h inspection, testing, fabrication, E

(4) A condition or circumstance in-the regulations in this part.

j M replacement parts, or consulting volving a basic coreponent that could E services that are associated with the a

contribute to the exceeding of a safety g component hardware whether these Hmit, as deftned in the technical spect-

~

)

services are performed by the fications of a license for operation F

L. component supplier or others.

issued pursuant to Part 60 of this

$ 21.4 Interpretations, D N ** "P**

""UY ""Ih I**d N Commission in wrMng,"no inter-(efdeviation" means a departure a

(4) A commercial grada item is not a from the technical requirements in :

cluded in a procurement document ; pretation of the meaning of the regu-part of a besic component until after dedicatica (see l tt.3(o-1))-

f th Co ion other g

(f) " Director" means an individual. I hm eye (see i 21.3(1)).

tal h **means g

sa llem that is (1) not subject to design appointed or elected according to law, [ General Counsel will be recognized to and be binding upon the Commission.

ce specification requirements that are who is authorized to manage 5

s:nique to facilities or activities IIcensed direct the affatra of a corporation, l

% pursuant to Part:30,40. $0, 00,61,70,71. or partnership or other entity. In the i

A 72 of this chapter and (2) used in f an indMdual proprietorahlp, case director" me*D8 the individu*I-t21.s h w E applications other than facilities or Except where otherwise specified in

$ actMtieslicensed pursuant to Parts 3(L this part, all written communications

'I

40. 50,80.61,70,71.,or 72 of this chapter

- (g) Discovery means the completion of and reports concerning the regulations and (3) to 14 ordered from the the documentation first identifying the E in this part must be addressed to the 4

saanufacturer/ supplier on the basis of specifications set forth in the existence of a deviation or failure to

% Document ControlDesk,U.S. Nuclear manufacturer's published product comply potentially associated with a g Regulatory Commission, Washington.

description (for eammple a catalog).

substantial safety hazard within the DC 20555.In the case of a licensee, a evaluation procedures discussed in g copy must also be sent to the l 21.21. (a).

appropriate Regional Administrator at

~

Nb (b) " Commission ** means the Nucle.

the address specified in appendix D to l

part 20 of this chapter.

E at Resulatory Commission or its duly (h) Evoluotion means the process of I

L authorized representatives.

determining whether a particular

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deviation could create a substantial

• • 8

' ' *1I"

I 21.5 Poetlag requirenwnts.

(a) Each individual, partnership, cor-m an the a ea d c

f manufacture, fabrication, placement' substantial safety hazard.

poration or other entity subject to the regulations in this part, shall poet cur-erection, installation. modification.

(i) Notification means the telephom.e inspection. or testing of a facihty or

. communication to the NRC Operations rent copies of the following documents w wrtuen transnuual of in a conspicuous position on any prem-E activity which is subject to the h inf rmation to the NRC Document1ses, within the United States whert R regulations in this part and consulting the activities subject to this part are services related to the f acility or activity e ControlDesk, conducted (1) the regulations in this t

that are safety related.

2 (J) Operating or operauon means the part,(2) Section 206 of the Energy Re-operation of a facibty or the conduct of

- organization Act of 1974. and (3) pro-a licensed activity which is sub}ect to cedures adopted pursuant to the regu-the regulations in this part and

lations in this part.

(b) If posting of the regulations in

~ (0-1) " Dedication" of a commercial consulting services related to operations E

I, this part or the procedures adoptedp grade item occurs after receipt when that are safety related'

that item is designated' for use as a part is not practicable, the licensee or

basic component.

(k) " Procurement document" means firm subject to the reguleLtions in this i

{

a contract that defines the require-part may, in addition to posting see-l rnents which facilities or basic compo-tion 206, post a notice which describes nents must meet in order to be consid-the regulations / procedures, including

"~

d) " Defect" means' d

((1) A deviation (see i 21.3(e)) in a ered acceptable by the purchaser.

the name of the individual to whom (1) " Responsible officer" means the baale component delivered to a pur.

president, vice-prealdent or other indi-reports may be made, and states where chaser for use in a f acility or en activi-vidual in the organization of a corpo-they may be examined.

I (c) The effective date of this section a

{ ty subject to the regulations in this ration, partnership, or other entity has been deferred untt! January 8, part if. on the baals of an evaluation who la vested with executive authority

• (see l 31.3(g)), the deviation could 1978.

over activities subject to this part.

f create a substantial safety hazard; or 21-2 April 30,1992 I

i l

l l

-,- ~ _ - - -

n

2I'2IId)

PART 21 e REPORTING OF DEFECTS AND NONCOMPLIANCE f I 21.1Esemptions.

(3) Ensure that a director or has been received should be made by The Commission may, upon applies.

responsible officer subject to the calling the NRC Operations Center.This tion of any interested person or upon regulations of this part is informed as paragraph does not apply to interim E its own inillat,1ve, grant such exemp.

soon as practicable, and, in all cases, reports described in i 21.21(a)(2).

E tions from the requirementa of the within the 5 working days after (ii) Written notification to the NRC at regulations in this part as it deter-completion of the evaluation described the address specified in i 2L5 within 30 mines are authorized by law and will in i 21.21(a)(1) or i 21.21(a)(2)if the days following receipt of information by not endanger life or property or the construction or operation of a facility or the director or responsible corporate common defense and security and are act;vi'y, or a basic component supplied officer under paragraph (a)(3) of this t

ot.herwise in the public tr*.erest.

for such facility or activity-section, on the identification of a defect -

(1) Falls to comply with the Atomic or a failure to comply.

~

g Energy Act of1954, as amended, or any hpliers of commercial grade items a epphcable rule, regulation. order. or t

r' ed b rbp h

e t

exempt frorn the provisions of this license of the Commission relating to a E part to the extent that they supply substantial safety hazard, or not be limited to, the following infor-

commercial grade items.

(ii) Contains a defect.

mation, to the extent known:

(D Name and address of the individu.

corr 1 sds v dy a pl er of 1[on basic components, or services (11) Identification of the facility, the Mass W associated with basic components, and activity, or the baale component sup-tn n plier determines that it does not piled for such facility or such activity

. (aj ne Nuclear Regulctory have te capability to perform the within the United States which falls to Commission has submitted the evaluati n to determineif a defect comply or contains a defect.

.information collection tokutrements exists then the supplier must inform the (111) Identification of the firm con-contained in Wa part to a Office of purchasers or affected licensees within structing the facility or supplying the Management and Budget (OMB) for five working da e of this determination -

basic component which falls to comply approval as required by the Paperwork so that the put asers or affected or contains a defect.

Reduction Act of 1980 (44 U.S.C. 3501 at licensees may evaluate the deviation or (iv) Nature of the defect or failure to i seq 10MB has spproved the failure to comply, pursuant to i 21.21(a).

comply and t,he safety hazard which is e information collection requirements (c)(1) A director or responsible officer created or could be created by such contained in this part under control subject to the regulations of this part or defect or failure to comply.

number 3150-0035.

a person designated under i 21.21(c)(5)

(v) The date on widch the informa-(b) ne approved information must notify the Commission when he or tion of such defect or failure to oom I was obtain collection requirements contained in this she obtains information reasonably g

part appearin $ $ 21.21 and 21J1.

dica a failure to comply or a defect 3 which contains a defect or fails to (i) %e construction or operation of a e mply, the number and location of all I" "** "k

• NorsricatioN facility or an activity within the United

"", or* being supplied for one or anore l

a-for j

w g. States that it subject to the licensing facilities or activities subject to the i

g g

requirements under parts 30,40. 50. 80-regulations in this part.

l

,% g m g, %m p

(a) Each individual, corporation.

fe wi in'h a or er o n zs o)s hat

(

Thec ective act n partnership or other entity subject to responsibility; or 21ame of the individual or organization the regulations in this part must adopt (ii) A basic component that is within responsible for the action; and the I

appropriate procedures to-his or her organization's responsibility length of time that has been or will be

]

(1) Evaluate deviations and failures to and is supplied for a facility or an taken to complete the action.

comply to identify defects and failures activity within the United States that is (vill) Any advice related to the to comply associated with substantial sub}ect to the licensing requirements defect or failure to cornply about the safety hazards se soon as practicable, under parts 30, 40, 50, 80, et. 70. 71. or 72 facility, activity, or basic component and, except as provided in paragraph of this chapter.

that has been. is being or will be given (a)(2) of this secuon. in all cases within (2) De notification to NRC of a failure to purchasers or licenaces.

00 days of discovery, in order to identify to comply or of a defect under (5) The director or responsible offi-e reportable defect or failure to comply paragraph (c)(1) cf th!s section sad the cer may autt.orize an individual to th at cou'.d create a substantial safety evaluation of a failure to comply or a provide t!'e notification required by hazard were it to remain uncorrected, defect under paragraphs (a)(1) and (a)(2) this paragraph, praided that, this

[K ar.d of this section. are not required if the shall not telleve the itirector or re-(2) Ensure that if an evaluation of an director or responsible officer has actual sponsible officer of his or her responsi-l.

E identified deviation or failure to comply knowledge that the Commission has bility under this paragra?h.

l g potentially associated with a substantial been notified in writing of the defect or (d)lndividuals subject W this part safety hazard cannot be completed the failure to comply, may be required by the Commission to.

within 80 days from discovery of the (3) Notification required by paragraph supply additional information related to deviation or failure to comply, an (c)(1) of this section must be made as a defect or failure to comply, interim report is prepared and submitted follows-Commission action to obtain additional to the Commission through a director or (i) Initial notification by facsimile, information may be based on reports of responsible officer or designated person which is the preferred method of defects from other reporting entities, se discussed in i 21.21(c)(5). %e interim notification, to the NRC Operations report should describe the devistion or Center at 301-492-8187 or by telephone i

failure to comply that is being evaluated at 301-051-0550 within two days I

and should slso state when the following receipt of information by the l

evaluation will be completed.%fs director or responsible corporate officer interim report must be submitted in under paragraph (a)(1) of this section on writing within 80 days of discovery of the identification of a defect or a failure the deviation or failure to comply, to comply. Verification that the facsimile I

l 21-3 April 30,1992

g 21.62(h) -

.21.31 PART 21

• REPORTING OF DEFECTS AND NONCOMPLIANCE Euroscum7 PnocummmT Docoumis 7 21.31 Procurement documents.

Each Individual, corporation, part-nership or other et.tity subject to the '

$ 21.61 Failure to notify.

.d regulations in this part shall assure Any director or responsible officer th t each procurement. document ior a d subject to the regulations in this pari fccIllty, or a basic component issued E who knowingly and consciously f ails to by him, her or it on or af ter January "a provide the notice required by % 21.21

' 2 6,1978 speelfles, when applicable, that [ shall be subject to a civil penalty equal

. T. the, vvisions of 10 CFR Part 21 in the amount provided by section 234 of

- [ CPply.

?

the Atomicf.nergy Act of 1954, as e

Insrecuens, Reconns

$ 21.41 Inapeetions.

amended.

E ch individuni. corporation. part-

~

nership or other entity subject to the regulations in this part shall pertnit INote removed 49 FR 196231 July authorir.ed representatives of the Cornrnission, to inspect its records,

' premises. activities, and basic compo<

nents as necessary to effectuate the purposes of thts part.

$ 21.62 Criminel penalties.

j d

)>(a)Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willf ul violation of, atternpted violation of, or conspiracy f,

3 lw. t Maintenance and inspection of to violcte, any regulation issued under recortis.

"*U

' #' "' * "I O' ^"

{m) Each individual, corporation.

cw For purpons of ncdon 223. ay 6e 8

partnership or other entity subject to g regu ations in part 21 are issued under the te8ulations in this part must prepare one or more of sections 101b 1Gil. or e

end maintain records necessary to D; 1610, except for the sections listed in 4

accomplish the purposes of this part, paragraph (bl of this section.

rpecifically-(bl The regulations in part 2* that are l1) Retain evaluat; all not issued under sectione 161b.161i. m devletions and failure. %;mply for a 1f11o for the purposes of section 223 are minimum of five years after the date of as f ollo il 2M 2M 2M 21.4 213.

the evaluation:

21.7. 21 n. 2161. and 2122 (2) St pplicts of besic components

'~~~

must retain any notifications sent to purchasers and m!!ected licensees for a minimum of five years after the date of the notification.

(3) Suppliere of basic components py must retain a record of the purchaseis of basic components for 10 years after u-

I?> dallvery of the basic component or cervice associated with a basic 1

component

- (b) Each Individual, corporation.

4 p:rtnershipior other entity subject to the regulations in this part must afford the Commission, at all reasonable times.

the opportunity to inspect records pertsining to besic components thet relate to the discovery evaluation, and trporting of devlations, failures to comply and defects, including any advice jtiven to purchasets or licensees on the placement, cr ction. irM a!!ation, operation. rnaintenance, modification. or inspection of a basic component.

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.en enne)