NRC Information Notice 1991-039: Compliance with 10 CFR Part … · 2012. 11. 18. · to be a defect, and NRC was not notified of the defect, as required by 10 CFR 21.21(b). A contributing

W. . UNITED STATES* NUCLEAR REGULATORY COMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555

June 17, 1991

NRC INFORMATION NOTICE NO. 91-39: COMPLIANCE WITH 10 CFR PART 21,"REPORTING OF DEFECTS AND NONCOMPLIANCE"

Addressees:

All Nuclear Regulatory Commission (NRC) material licensees.

Purpose:

The purpose of this notice is to remind licensees of the requirements containedin 10 CFR Part 21, "Reporting of Defects and Noncompliance" (Attachment 1). Itis expected that licensees will review this information, distribute this noticeto responsible staff, and consider actions, if appropriate, to ensure compliancewith applicable requirements. However, this notice does not in itself establishany new requirements.

Description of Circumstances:

Past inspections at materials licensees indicate that many licensees are notcomplying with all the requirements of Part 21 and are unclear about theapplicability of Part 21 to their licensed programs.

In'one case, a company supplying teletherapy units discovered a failure, in atimer which could have resulted in a substantial safety hazard. Althoughthe failure was evaluated and the timer was determined to require replacement,an evaluation to determine if a substantial safety hazard could exist was notperformed. As a result, a responsible officer or director in the licensee'sorganization was not informed that the timer contained what NRC later determinedto be a defect, and NRC was not notified of the defect, as required by 10 CFR21.21(b). A contributing factor in this case was the failure to establishappropriate procedures to evaluate whether a deviation could represent asubstantial safety hazard, as required by 10 CFR 21.21(a).

In another case a radiographic equipment manufacturer reviewed circumstancessurrounding separation'of a source assembly from the drive cable. Althoughthe licensee took actions to recall the defective source, it failed to reportthe defect to NRC and had not developed procedures for evaluating manufacturingdefects, to determine applicability to Part 21 reporting.,

Discussion:

Part 21 was issued in June 1977, and applies to all licensees and certainunlicensed vendors. The requirements in Part 21 are to ensure that equipmentdeficiencies or failures that could create a substantial safety hazard involvingNRC-regulated activities are reported to NRC. Prompt licensee reporting of

91061-10125e-11C

PI% I te tookc4 9l

An;_ - -

"II0l oet

oe < IN 91-39June 17, 1991Page 2 of 3

defects will enable NRC to determine if a defect is generic in nature, so thatappropriate measures can be taken to ensure protection of the public healthand safety.

The requirements are based on Section 206 of the Energy Reorganization Act,which states, in part, "Any individual director or responsible officer of afirm constructing, owning, operating, or supplying the components of any facility f-or activity which is licensed or otherwise regulated pursuant to the AtomicEnergy Act of 1954, as amended, or pursuant to this Act, who obtains informationreasonably indicating that such facility or activity or basic components suppliedto such facility or activity (1) Fails to comply..., or (2) Contains a defectwhich could create a substantial safety hazard, ... shall immediately notifythe Commission of such failure to comply, or of such defect...."

The principal requirements of Part 21 include the following:

(1) Licensees must post required documents related to Part 21 in aconspicuous location. These include a copy of the regulation, Section206 of the Energy Reorganization Act of 1974, and any procedures developedpursuant to Part 21. [10 CFR 21.6(a) and (b)]

(2) Licensees must-develop procedures for identifying and evaluatingdeviations, or informing affected customers, so that the customer canevaluate the deviation; and must also develop procedures for reportingdefects to a director or responsible officer. [10 CFR 21.21(a)]

(3) Licensees must report defects to NRC, within certain time frames.(10 CFR 21.21(b)]

(4) Procurement documents issued by the licensee for basic components muststate that Part 21 applies to the procurement. (10 CFR 21.31]

NRC staff recognizes that these requirements are very broad and requireconsiderable licensee judgment to implement. As a minimum, licensees shoulddetermine which aspects of their licensed activity could result in a substantialsafety hazard from a defect in a basic component. Attachment 2 providesguidelines for determining what constitutes a substantial safety hazard.NUREG-0302, Revision 1, published in October 1977, provides responses toquestions on Part 21 raised in public regional meetings and contains severalexamples that will provide additional guidance on what constitutes a substantialsafety hazard. Copies of NUREG-0302 may be purchased from the National TechnicalInformation Service, Springfield, VA 22161.

Furthermore, licensees are required to have procedures that implement therequirements to report defects. Procedures should assign responsibilities tothe appropriate individuals, to identify and report deviations to responsiblecompany officers. The responsibilities of company officers should be described;that is, to evaluate and report deviations to purchasers, and to inform NRC ofdefects within the required time frames. Licensees should evaluate their ownprograms and develop procedures appropriate for their activities. Attachment 3provides a sample procedure for identifying and reporting defects, under Part 21.

-i IN 91-39June 17, 1991Page 3 of 3

Manufacturers or suppliers who provide licensees with basic components thatcontain, or are used with, radioactive material, would normally need moreextensive procedures to ensure proper identification and reporting of defectsthan customers who do not supply components to others. These procedures shouldcontain, as a minimum, the following:

- 1. Directions to acquire information sufficient to describe the deviation.

2. Directions to analyze the effect of the deviation, in a basic component,if used by a licensee.

3. Directions to reach a conclusion, based on the analysis as to whether thedeviation could create a substantial safety hazard.

Licensees are subject to inspection for compliance with Part 21, as wellas other applicable NRC requirements, and may be subject to enforcement actionfor noncompliance. This information notice does not require any written response.If you have any questions about this matter, please contact the technical contactlisted below or the appropriate NRC regional office.

Richard E. Cunningham, DirectorDivision of Industrial and

Medical Nuclear Safety

Technical Contact: Cheryl A. Trottier, NMSS301-492-3422

Attachments:1. 10 CFR Part 212. Guidelines for Determining Whether a Substantial

Safety Hazard Exists3. Sample Procedure for Identifying and Reporting

Defects Under 10 CFR Part 214. List of Recently Issued NMSS Information Notices5. List of Recently Issued NRC Information Notices

c.1

Attachment 1.UNITED STATES NUCLEAR REGULATORY COMMISSION June 17, 1991

RULES and REGULATIONS Page 1 of 2TITLE 10. CHAPTER 1, CODE OF FEDERAL REGULATIONS - ENERGY

21.1

PART

.aaz NOIIS..... 02113 PYSP10

1i WPurpose.21. Scope21.2 Defnintions.21,4 Interpreta±Iom.21. Colmunicaticns,21.5 Post~ng ftqulirnint&

21.5 Isfamatka coletiom aquemOUD appraL

3214 Notificatin Of faiure to Ioexistence of a deect.

ftoumSL1 Pr et ment.

lzeros Uso21.1 tlo

21*1 failure So not~y.

amnSO me. MAL 23U a Mn" Umm414m USC.OLU*_.

6ee. 21241aho baedoindn sm. 125Pwb. L P4L StaLU2IM U (42 V.

Lo Silas m sad assatiled.01) to=1101.1 11ed2.1w mdn

i 0o, hL m -emed( P E103.31

Teregulate"ionn this pert

Impemetatonof seotionNo~ser BargaissicmAct'@1

Lfad

That ectin eulrsusany mEctor am em" nie o

of1c.woa~rcig wig p

a sauply * tltn n

fy.actiity0 motr~t Which copospteriserlued pouc aclt r &UatRIAtmoarly withythc Atfmic54. ug

ty95. acivit amendsi oraNWone

-rule regulation order, or RII=the Commission relatig to sus

21.3(a)

REPORTING OF DEFECTS AND NONCOMPLIANCE

safety hazards or (b) that the facility. grado Item (e I 2i(afl t subjectactivity. or basic coMPoent supplied So the regubons thb pat fom-to such facility or activity contain de- to theprngulato in theo isspon anon:feeta. which could create a substaptial ffe orttns t o ch omtin2komplyCsafetyL hazard, to immediately notlfy and. as dutored oy iasl. toe Ideniy

z the Commission of such failure to an.sauhrzdblateiniy6 comply or such defect, unless he has of a ryone t w e withheld

actal nwledge that the om tmwUdon: aben dequately inforned of such

deaect or ilure to comply. I221J D allous.Isued i Ui art:

no or I au sope. ptXI) "Badc comW t." when WThe regulatio In td part pply. .id to nuclear poer a s

except a specifically provided a plant sucre system, componentotherwise In Parts 31.34. 3S. 3.4. O. or Purt thereof noesary to asure (1)61. 70 er 7 of tils chapter. to each the integrity Of the reactor coolantIndividual, partnershlp, corporation. or PruIW bOuntday, (Ii) the cpabilltyother entity licensed pursuant lo th to shut down the reactor and maintainregulations Intis ch dl It In aL safe .hutdmow conidition or (IIIuse ad/o %amfr ar'10P03112L the capabilit to pMee or mitigatueanlranerwithin the United the consequences of accidents whichStates source material, byproduct could result In potential offalte expo.material special nucla material. andU suree omparable to the referred toorspent fuel and I4vel radioactive In I 100.11 of this chapter.waste, or So c2) 'Bade component," when appliedpossess, own, operate anderr tnfr to othe faciltie and when applied to

0L within the United S&ta any production o ther acivties. loined _urguant toor utlizationahterlne penot Pdts 11O. 40, 50. 60. 61. 70. I. or n2 ofs- nt h stom p this chapter meinx a component,

ML mntre erealse . ntaaion structure ysteM, or part thereof thatri , monitre ttrbievble natetoh zl4brtl lcepst~004 = to ach irecorit directly procured by the boans. of12RS n Soeadrto(a facility or activity subject to the reg-

us,. I 2.2(1) ad rsponibl oficer(se ultiona In this Part and in which aE I uch alceee.defec (see 12L3(d)) or failure to

I I ga In this part apply'also So comply with ny applcbe tgatonM e IndlvIdual corporation. In this chapter. order or Iene Issued

Carslp orrotSr entty doin by the Commission could create a sub.n SitteWd 8ta nd -stl saety heard (me I 212C)l.

each direco and respoible offlcer of (2) I an eaP -bad co tw insuc 412111311tontha cnstuct (1111 ludes, desiga ftopection. teattng or

Isuch pran ductiou tautclizatione cnsltn services important to ssfet),11i.8 c)l a productionulfation hat eo with the compo-

li d u ct en hardware whether these serice.utah- construionr oprtion (see ILnthD are performed by te component gap-t or puatSoP"t0dofichapteran plier or oths

of the -ndpeden t t std.a.-194 tala ( f the stoap of ratc s.C0W eemi,,mwU :mm pe ld

WIwit spent fue l d p ant to Part n of Ih S Ih s hkm' H sin wH nr of a this chaer or a to d t bl NRC um m W m .Wating "I rb"Miomf ny tom Instaithe r ll.u nd N3e a" S-esdor storage of spent hdeorm high-eve = I4 FRU24e7ti radioaiv wat licnse puruat So

en~ Pat 2oftis chapter,orspplis(m

mra- { tuL3(afra facility o acthrity s guahsfadll- lcenseother tanfrexport, une ____

raubils ,tro Iv , tt tt Is 1apter. Noth In n ctheeX4=A of n*37 Ndbsvt"wO.MXlicable rgltossolbededSoIV I*,..m amm"1w raw offimane of pr ethran Indi l ora s_ a i

ntll manufact rip~lw r faonmecal w t ,.... H t

21-1 October31, 1989

/-21.3(a)

PART 21 * REPORTING OF DEFECTS AND NONCOMPLIANCE ' 1.6(c)

(43 A commercial Srad Item is not apaut ae bais componant until anrdeicaoe (se I 2 o-lo.1

(a-1) Commercal Uresd Item" maInsU5 Item that Its (1p ot subject to desipof specllcatlom requiremento that areunique to facilitIes oa acivitine licensdI

: pual to hrs Mi. 40. X 8M,1.706 JL oof tis hapter ad2 ed In

* appltons othet than aclties atactivies icense Pursuat to Parts 3,4.OMO 41.7Onw 7l269Uth chapterNW d(3 to be ored omtfhLsanufacturar/supal on th basis ofspecdt 3, Cribto themanufachres -p ddescruptim (for examople a catalo.

I.

- IIII

(b) Commlslou mea the Nude.ar Regulatory CoMMISaIn oW its dulyauthortzedl representatlvye(C) "Constructig or "construction"Means the desn, mnufas ure, Sbri.cai, placeMent, eretion, stafftion IOdlfcton, nsecton, orte-in fas faclit or atity whic Issubjc to the regulazn In thi parand cosmng sevcsrelated to theailt ow civt that ar motnt

tosfey

(4) A conditIon or circumstance Ifnvolving a basic component thtcud (I) "Supplying' Ow "supplies" means.contribute to the exceedingthaa~ty Col ~ UStW epnil for a basiclimit. us defined In the ofa safwetF component ued of to be used In f a.

limitoas dfinedn the sped. cntY Or activity which Is subject tofiala faUeufor operation the reultlonInti SIssued pursuant to Paut 30 of thisntohipa.chapter.te) "Deviation" means a departure ;from the technical requirements In ZI 1_ Intawsadomeluded In a procurement document Exceot as specifically authorized by(se 121.3(1)). masa nidUL the Commission las writing no Inter.( Dprotb of the meaning of the regpoappointed ow elected according to l. lations In thi pat by any officer owwho Is authorized to manage andh Co m sio odirect the affairs of at corporation. eIlyeo thaawiten Intrprtaison bytherpartnershIp ow other entity. In the G r Cous V be recognied tocase af an Individual proprietorshlI b binding upon the Commi Ision,'dlrectoe means the Individual .sg) ETvaouetlon" Mean the processaccomplished by or for a lcensee to rdetermine whether a E devi. I :21.5 Comml, cao a...aon could create a ubstanlUal saoty E.cepi whhi otherwiSa speclied Inehazard. this parp. Slu communications and(h) "Operaeti or "operatI mpeorna crarng the nC.ulatlana inmeans the operation of a facility ow thit pin to*huld 1w adldkeed to thrthe conduct of A licensed actvity Dn!,cmo. Office of %ucitar Reactorwhich i8sSubject to th. regubatoznj In Iclt~pvion or Dwrecton. Offic, ofthis Padt and conultin 3erVIce rezlat .0 Nuclear Material Safety and Safeuard&,ed to operations that arhe mportant to - opt U.S, u

(U 'PCommissA on. Waaihington, DC 2=58 ora cotratv that defines the reu.to the Administrator of a Reponalmets which facilities ow basis compo OfficeaI the address specifted isDents must meen In order to be conad. Appendix D of Purt 20 of this chapter.rend acceptable by the pVrvhiff. Communications and reports may be(J) 'Rexpongible officer" Means the delivered In person at the Commissdon'spreidatvle~paiat r the tWi offices at 2120 L Street NW.vidul t th oraniztimof copo.Washington. DCor- at as22555 Rockvillehtlo, ptnerhlp owothe enity Pike. Rockville. Mazry4an

r,,, (o-) 'Dedication- of a commereij, gade Item occura after receipt when

tha Item Is desgated for use as abasi compnen

L

Cd) "Ddefet" meannr (1) A devian (e I 2L3e)) to abasi component delivered to a pup IL'Sutantil saet hazanr medeschae r uu In a facility or ai dsetan tIoo th sexteL t subject to th re_ In thU tthuetaIs a ma* Wree to he- pILaton the bai fa vlaindegre &Woltil rovide to publisosaji .. hea the'ltc Urif forany bftyorL~~~ow actmv n itftsIN et

(2) The ri 1 or ohcatrI

ns gCS) Each Individual partnersht cop.porlon or other entity subject to theregulations tn this parthal pa cur-arent copies of the following docrmmnW

to a consplctico poaltiol on any pr-1ee, within the United t"a whmthe activities subjec to thi pueconducd (1) the reguaIMM In thispt (2) Bection 0@ of the Xr Re,orgaNS&IM Act of 13. and C pre.0eduve adopt pWuat to the root.lationsia n this PUrtb) Uf posting of the regulation lathis pet ow the proere adopedpursunt to the regulationg In thisPa Is not practicable, the Insee orfirm subjet to the regulaton in thisst may, in adtion to poet ngsta'n 206. pMo a noUoti which decnimthe ocprocedrae Includrg lthe name of the individul to whomr rtmy be made, a s whethey may be examined.

Ce) The effective dat ot thiseti on~elhas been defered until Jaur 6,

IS0

I5

Ulan of a bai compoent containingA defect u defined to par ph MdXU)of this :ctio or(3) A deviation to a poriona oat ai fcity subjec to the constrUon

permi o manufacturing liceng re-quirements of Pt 50 ot this chaptrprovided the deviation could, on thebasis of an eVlUaion, crate a sub.stantill safety hazrd and the portionof the facility containing the deviautonhas been offered to the purchaser foracceptunce or

November 30, 198S 21-2

Attachment 1IN 91-39JUne 17, 1991Page 2 of 2

21.7 PART 21 * REPORTING OF DEFECTS AND NONCOMPLIANCE 2511b)

Slates that Is sub ect tq the licensing facility. activity. or buic componentJ 21.IJ ExemptlBL requirements unter Parts 30 4A 80 eo . t~hat hus been. Is being. or w111 be given

The Commission may. upon appliea. n. At n of this chapter and that s to purchasers or licensees.Uon of any Interest~ed person or upon w~sithbhisorpnaltaton's esponeibillty (4) The directcr or rsponsible otn-It O Initiative. grant such exerp r (U) a basic component that is hn may authorize an Individual totions from the requirements f e his Organizations rponsibilitynd provide the notification required byregulations in this pan deter. supplied for a facility or en achvi stall notr relaev the dectetr or-re

mines re aut aoseee shd tn e Wn tqeeyIraede ahtfA lllr nto reomleetedretro.e

orizd by law and will , within th United States that is 0 gponsible officer of his or her responso-not endanger life or property or the oto licnsing requirements Know bb ty under this paragraph.

comndfneadscrt n e Pante mur be sm ede viti 2 n. y orr or ofxe "xysbett h

co m monwi d n se and s e r y a retac0.7s71.elpt of thi in a o bjct to paragraphoth i tchapter. The abovdenotification Is Aot (b) of this section may be required by

Irequired If such individual has actual the Cominissivet to supply additionalSup- 113ow1led1e that the Commission bas Information related to the defect or

: pliers of commercisl grade Items are Ibeen adequately informed. ofsuch defect faflure to comply.exempt from the provisions of this O r S i tobcmply. Patocuri2n a- r DoctI upe sapt to the extent that they supply & zu Procurembet docbumeta.

paragraph must be made within 2 days nership or other entity subject to the1110 domalo smeomfollowing receipt of the information. rglatloPJ In this vant shall Assure

id 31. b, ui .f dI 1 Notification must be made to the that each procurement, document for A,ie ,i am go Director. Office of Nuclear Reactor facility, or a basic component Issued

(a) The Nuclear Reoulator I Regulationr or Directo Office of by him, her or it on or after January

contained no this too n g 20535. or the In tCMmI1-21on has uditt It Nucle aterl Setyenctd Seeads h o PlC l thaaeen t. Uudie lmt( )dto the Administor of acReiol te ledtos.approval a required by the P ork N ce if en dr n t ibmeans t Indthle puaReduction A~t other than written communication

0e141' has aploved written report must be submitted tothe nerhip or other entity subject to to(1}sed= aPpropriate Offcer wI)hin 1 ldays after regulations In this part shall permit

ionfrmaD In coletion pc durate Ofc w ohn d aer eup y authorzed representatives of thecontained this prt uthe information is obtained. Three 8 Comh t llm to prect a rs .aumbeer tihe4l. copies of each report must be submitted a.oprmt- acutivt and basic c ompo -

(b) Th approved Information to the Director. Office of Nuclear " nents As necesry to effectuate thec i urements contained In ts IReactor Regulation. or Director. Office purposes of this part.part app r gzar it M d JL I of Nuclear ateril Safetyand I ISI KalatesateeeU of Uests..L eo fr rd n as appropriate. (b y o ch licansee on facilit or So-

tozztxJJ U Ml Sty I A r z}nhec t d nt~ t sur bjer to the regultrions con cs122) <>Dntricaio ofd ecLlffs to goo* (c thec wrottlns * epect oreqi by puto nntt uchl mantin ubchJee Iet nsi

2t. eOilco f F cl s this paragraph shall Icue butneedi connection with the licensed facility_ terreduteUe J e nurrnot be limited Wt. the following Infor or activItY ta may 'be required to

(a) Each Individual, coprto. Maton to the extent knwn . tr compliance with 'the regula.partnerstip or other ec) Name end address of the *ividu- tu; in this part.the riepasations In this paut Shall adot I or InvduJ informing &he CoM. tb EWAc indiIdUUAL. co~rpoatonappropriate procedures Io: mini.m partnership, or other entity subJect to

ct) Provide for. ( o) E Saluating dcvi ( Identification of the facility, the the regulations In this par shall pr* etons, or (U) Informing the licensee or acvty, or the basi Component sup. par records In Connection with theI purchaser of the deviation In Order plied for such facility or such activity designs, manufacure, fabrimcai.that the licensee or purchlaser * witan the 'Uited States which tai to c re to be erecton. nalation.cause th deviation to be evaluated comply or ContaisI caodect. modification. Inspection. or testing of

. unless the deviation has ben core- I et IdentIfictio of the frim con.: any facility basic component suppliededt and 1 strUCting the facilty Or supplying the for any licensed facility or to be used

(2) Assure that a dtirctor Or resPOn.: basic component which fails to comply Ii n iesdatvt ufcettsbeofcriifomdIt tbs Con-: o.r Contains a. dfefaLt I assure comnpliance with the regula.

atrctivony or operati c ponnofafclty orp Cs4 (IT) Nature Of the defec Or failure to t ons In t PArt After delivery of theco et Comply and the safety h Which t facility or component And prior to thefor such facility or ativ c e re by suche

(I) Valls to COMp ith t Atomc th de fawe to copucl. pu r un leto tEnergy2Act of 1984 as ameed. Th evaluatns (we I 21.3(g)) or fotifies.LWaY amplcabie rule regulation. Or , (t)on of su nVlch Ueec o iifarnure tions to the Commission (me 1 21.21).or license of the Commission rlelatin ofy wsuc e to obtauned.osuch tecords shefl be offered to theto a substantial safety hazard. or (vi) In the case of a basic component purchaser of the facility or compo-

(ii) Contains a defect. The effective which contains a defect or falls to nen. If such purchaser determinesdate of this paragraph has been de- comply, the number and location of all my Mich recordsoferred until January 9,1971.suci components in ane at supplied (1) Are not related to the creation of

for, or being supplied for one or more IL substantiall safety hazard. he MAYr (DA dieco o o shl offiear facilities or acTtiviie subject go the authorize such records go be de.l s oji the eultosfthspart or regulations In this part stroyed, or

N einae eso hl iof (vil) The corrective Action which his (2) Are related to the creation of aCOW5I~ 'I5been, in being, or will be taken:~ the substantial safety hazard, he shall

U. ioratonun resnal Indicating a name of the Individual or organization ~csuse such records to be offered to the; failure to Comply aa defect affectingl (1) responsible for the action.; an the organization to which he Supplies

the construction or operationc of a length of time that has been or will be basic components or for which he con-facility or an activity within the United taken to complete the Action. structa a facllity or activity.

(viii) Any advice related to thedefect or failure to comply about the If such purchaser Is unable to make

the determination As required above21.3 November 30, 1988

21.51(b)PART 21 * REPORTING OF DEFECTS AND NONCOMPLIANCE

then the responsibility for making thedetermInation shall be transferred tothe individuaL corporatioL partner-ship or other entity subject to theregulations in this part that issued theprocurement document to the pur-chaser. In the event that the determi.nation cannot be mede at that level

" then the responsibIlity sua be trans.erred In a similar manner to another

IndiciduaL ororton. partnershjp.or other entity subject to the regulb-tUons In thWe pat, untD. if neceeay.the licensee sha ma the determina.tion

(c) Records that ac prepared onlyfor the purpow of assuring compliancewith the regulaons I this put andare not related to evaluations or notif.cations to the Commission may be de-stroyed after delivery of the facility orcomponent.

(d) The effective date of the sectonhaa been deferred until January 6.

1979 -

ri ul Famweg.1fAny dhtcior o resoible oMce}subfd to am rulations i this pan

whkno owing ot sciousy* fals topre t notic rquired by 2121d b Ubkd toa|clvil penaj,,q ei

$ theamuneb~euo.a 4$it> of 194 *

oteab rgmove 49 FR 196231

November 30, 1988 214

I

Attachment 2IN 91-39June 17, 1991

* Page 1 of 1

- GUIDELINES FOR DETERMINING WHETHERA SUBSTANTIAL SAFETY HAZARD EXISTS

1. A substantial safety hazard means the loss of a safety function to the

extent that there is a major reduction in the degree of protection provided

to ensure public'health and safety. Note that the term "public health and

safety" includes both members of the public and licensee workers/employees.

2. From a radiological perspective, a substantial safety hazard exists if

there is a potential for moderate exposure to, or release of, licensed

material.

a. Guidelines for determining moderate exposure:

o Greater than 25 rem (whole body or its equivalent to other body

parts) to occupationally exposed workers in a period of a year or

less.

o Exposure of 0.5 rem (whole body or its equivalent to other body

-parts) to an individual in an unrestricted area in a period of a

year or less.

b. Guideline for determining potential for release of licensed material:

o Release of materials in amounts reportable under the provisions

of 10 CFR 20.403(b)(2).

For additional discussion, see NUREG-0302, Revision 1 (page 21.3(k)-1), which

may be purchased from the National Technical Information Service, Springfield,

VA 22161.

* -J Attachment 3

June 17, 1991Page 1 of 1

SAMPLE PROCEDURE FORIDENTIFYING AND REPORTING DEFECTS

UNDER 10 CFR PART 21

Employees shall:

1. Identify deviations in a basic component (insert appropriate part orcomponent nomenclature).

2. Promptly report the deviations to the responsible company officer ordirector (insert appropriate position).

Company official (insert appropriate position) shall:

1. Cause deviation to be evaluated or reported to purchaser.

2. If determined to be a defect, promptly (within two days of receipt ofinformation) inform the Nuclear Regulatory Commission (NRC).

- By telephone, facsimile, or in writing to the Director, Office ofNuclear Material Safety and Safeguards, USNRC, Washington, DC 20555,or to the Regional Administrator.

3. If initial notification was by telephone or facsimile, a written reportmust be sent to NRC within 5 days of receipt of the information.Submit three copies.

- Identify the basic component with the defect or activity that failedto comply.

- Include the nature of the defect or failure and the safety hazardcreated or that could be created by the defect or failure.

- Identify the date the information was obtained and the name of theindividual informing NRC.

- List all locations where the basic component may be in use.

- Describe corrective actions taken or being taken.

- Advice related to the defect that has been, or will be given tocustomers.

I

Attachment 4IN 91-39June 17, 1991Page 1 of 1

LIST OF RECENTLY ISSUEDNMSS INFORMATION NOTICES

Information . Date of

Notice No. Subject , Issuance Issued to

06/07/9191-35

91-30'

91-26

91-23

91-16

91-14

91-03

Labeling Requirements forTransporting Multi-HazardRadioactive Materials

Inadequate Calibration ofThermoluminescent DosimetersUtilized to Monitor ExtremityDose at Uranium Processing and

Fabrication Facilities

Potential NonconservativeErrors in the Working FormatHansen-Roach Cross-SectionSet Provided with-The Kenoand Scale Codes

Accidental Radiation Over-exposures to Personnel dueto Industrial RadiographyAccessory Equipment Malfunc-tions

Unmonitored Release Pathwaysfrom Slightly Contaminated Re-cycle and Recirculation WaterSystems At A Fuel Facility

Recent Safety-Related Inci-dents at Large Irradiators

Management of Wastes Contam-inated with RadioactiveMaterials ("Red Bag" Wasteand Ordinary Trash)

* All U.S. NuclearCommission (NRC)

Regulatoc1licensee.

04/23/91 All fuel cycle licenseesroutinely handling unshie'ed uranium materials.

04/02/91 All fuel cycle licenseesand other licensees, in-cluding all holders ofoperating licenses fornuclear power reactors,who use physics codes tosupport criticalitysafety in the use offissile material.

03/26/91 All Nuclear Regulatory Cormission (NRC) licenseesauthorized to use sealedsources for industrialradiography.

03/06/91 All fuel cycle facilities.

03/05/91 All Nuclear RegulatoryCommission (NRC) licensee!authorized to possess anduse sealed sources atlarge irradiators.

01/07/91 All medical licensees.

K) Attachment 5IN 91-39June 17, 1991Page 1 of 1

LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICES

Information Date ofNotice No. Subject Issuance Issued to

91-38

91-37

Thermal Stratification inFeedwater System Piping

Compressed Gas CylinderMissile Hazards

06/13/91 All holders of OLs or CPsfor nuclear power reactors.


91-36

91-35

Nuclear Plant StaffWorking Hours

Labeling Requirements forTransporting Multi-HazardRadioactive Materials

06/10/91 All holdersfor nuclear

of OLs or CPspower reactors.

06/07/91 All U.S. NuclearCommission (NRC)

Requlatorylicensees.

91-34

91-33

91-32

Potential Problems inIdentifying Causes ofEmergency Diesel GeneratorMalfunctions

Reactor Safety Informationfor States During Exercisesand Emergencies

Possible Flaws in CertainPiping Systems Fabricatedby Associated Piping andEngineering




91-31

91-30

Nonconforming MagnafluxMagnetic Particle (14AM)Prepared Bath

Inadequate Calibration ofThermoluminescent Dosi-meters Utilized to MonitorExtremity Dose at UraniumProcessing and FabricationFacilities


04/23/91 All fuel cycle licensees andother licensees routinelyhandling unshielded uraniummaterials.

OL = Operating LicenseCP = Construction Permit

IN 91-39June 17, 1991Page 3 of 3

Manufacturers or suppliers who provide licensees with basic components that

contain, or are used with, radioactive material, would normally need more

extensive procedures to ensure proper identification and reporting of defects

than customers who do not supply components to others. These procedures should

contain, as a minimum, the following:

1. Directions to acquire information sufficient to describe the deviation.

2. Directions to analyze the effect of the deviation, in a basic component,

if used by a licensee.

3. Directions to reach a conclusion, based on the analysis as to whether the

deviation could create a substantial safety hazard.

Licensees are subject to inspection for compliance with Part 21, as well

as other applicable NRC requirements, and may be subject to enforcement action

for noncompliance. This information notice does not require any written response.

If you have any questions about this matter, please contact the technical contact

listed below or the appropriate NRC regional office.

Richard E. Cunningham, DirectorDivision of Industrial andMedical Nuclear Safety





*See previous concurrence

OFFC: IMOB* : IMOB : IMAB* :IMSB* :NMSS* : IMNS* :IMNS/f/

NAME: CTrottier/ll:JHickey : JGlenn :CHaughney :EKraus :GSjoblom:RECtunhingham

DATE: 5/01/91 :5/ /91 : 05/01/91 :5/02/91 :5/16/91 :5/23/91 :6//J/91

OFFICIAL RECORD COPY

-

IN 91-June , 1991Page 3 of 3

the appropriate individuals, to identify and report deviations to responsible

company officers. The responsibilities of company officers should be described;

that is, to evaluate and report deviations to purchasers, and to inform NRC of

defects within the required time frames. Licensees should evaluate their own

programs and develop procedures appropriate for their activities. Attachment 3

provides a sample procedure for identifying and reporting defects, under Part 21.

Manufacturers or suppliers who provide licensees with basic components that

contain, or are used with, radioactive material, would normally need more

extensive procedures to ensure proper identification and reporting of defects

than customers who do not supply components to others. These procedures should

contain, as a minimum, the following:


2. Directions to analyze the effect of the deviation, in a basic component,

if used by a licensee.

3. Directions to reach a conclusion, based on the analysis as to whether the

deviation could create a substantial safety hazard.

Licensees are subject to inspection for compliance with Part 21, as well

as other applicable NRC requirements, and may be subject to enforcement action

for noncompliance. This information notice does not require any written response

to NRC. If you have any questions about this matter, please contact

Cheryl A. Trottier at 301-492-3422.






Defects Under 10 CFR Part 214. List of Recently Issued NMSS Information Notices

5. List of Recently Issued NRC Information Notices

*See previous concurrence t'

OFFC: IMOB* : IMOB : IMAB* :IMSB* :NMSS* : IMNS* :I

NAME: CTrottier/ll:JHickey : JGlenn :CHaughney :EKraus :GSjoblom:RECunningham

DATE: 5/01/91 :5/ /91 : 5/01/91 :5/02/91 :5/16/91 :5/23 91 :6/4l /91

OFFICIAL RECORD COPY :N S :NMSSIN/PART21 : ot o:RBernero

:6/ /91 :6/q /91

IN 91-June , 1991Page 3 of 3

the appropriate individuals, to identify and report deviations to responsiblecompany officers. The responsibilities of company officers should be described;that is, to evaluate and report deviations to purchasers, and to inform NRC ofdefects within the required time frames. Licensees should evaluate their ownprograms and develop procedures appropriate for their activities. Attachment 3provides a sample procedure for identifying and reporting defects, under Part az.

Manufdcturers or suppliers who provide licensees with basic components thatcontain, or are used with, radioactive material, would rnormally lateu moreextensive procedures to ensure proper identification and reporting of defectsthan customers who do not supply components to others. These procedures shouldcontain, as a minimum, the following:




Licensees are subject to inspection for compliance with Part 21, as wellas other applicable NRC requirements, and may be subject to enforcement actionfor noncompliance. This information notice does not require any written responseto NRC. If you have any questions about this matter, please contactCheryl A. Trottier at 301-492-3422.






*See previous concurrence (( C f-C' 'e ' .,) L .(?f\Lt< X /h'

OFFC: IMOB* : IMOB : IMAB* :IMSB* :NMSS* : IMNS* :IMNS

NAME: CTrottier/ll:JHickey : JGlenn :CHaughney :EKraus :GSjoblom:RECunninghdlfl

DATE: 5/01/91 :5/ /91 : 5/01/91 :5/02/91 :5/16/91 :5/23/91 :6/ /91

OFFICIAL RECORD COPY :NMSS :NMSSIN/PART21 :GArlotto:RBernero

:6/ /91 :6/ /91

* -4,

IN 91-May , 1991Page 3 of 3

the appropriate individuals to identify and report deviations to responsiblecompany officers. The responsibilities of company officers should be described;that is, to evaluate and report deviations to purchasers, and to inform theNRC of defects within the required time frames. Licensees should evaluatetheir own programs and develop procedures appropriate for their activities.Attachment 3 provides a sample procedure for identifying and reportingdefects under 10 CFR Part 21.

Manufacturers or suppliers who provide licensees with basic components thatcontain, or are used with, radioactive material, would normally need moreextensive procedures to assure proper identification and reporting of defectsthan customers who do not supply components to others. These procedures shouldcontain as a minimum, the following:


2. Directions to analyze the effect of the deviation in a basic component ifused by a licensee.

3. Directions to reach a conclusion based on the analysis as to whether thedeviation could create a substantial safety hazard.

Licensees are subject to inspection for compliance with 10 CFR Part 21, as wellas other applicable NRC requirements, and may be subject to enforcement actionfor noncompliance. This information notice does not require any written responseto NRC. If you have any questions about this matter, please contactCheryl A. Trottier at (301) 492-3422.



Technical Contact: Cheryl A. Trottier, NMSS(301) 492-3422





OFFC: IMOB* : IMOB* : IMAB* :IMSB* :NMSS : IMNS :IMNS

NAME: CTrottier/ll:JHickey : JGlenn :CHaughney :EKraus :GSjoblom:RECunningham

DATE: 5/01/91 :5/ /91 : 5/01/91 :5/02/91 :5/ /91 : 5/ /91 :5/ /91

OFFICIAL RECORD COPYIN/PART21


the appropriate individuals, to identify and report deviations to respornsiblecompany officers. The responsibilities of company officers should be described;that is, to evaluate and report deviations to purchasers, and to inform NRC ofdefects within the required time frames. Licensees should evaluate their ownprograms and develop procedures appropriate for their activities. Attachment 3provides a sample procedure for identifying and reporting defects, under Part 21.

Manufacturers or suppliers who provide licensees with basic components thatcontain, or are used with, radioactive material, would normally need moreextensive procedures to ensure proper identification and reporting of defectsthan customers who do not supply components to others. These procedures shouldcontain, as a minimum, the following:




Licensees are subject to inspection fur compliance with Part 21, as wellas other applicable NRC requirements, and may be subject to enforcement actionfor noncompliance. This information notice does not require any written responseto NRC. If jcu have any questions about this matter, please contactCheryl A. Trottier at 301-492-3422.








OFFC: IMOB* : I : IMAB* :IMSB* :NMSS* : IMNSX'.IMNS

NAME: CTrottier/l1:JRgd ey : JGlenn :CHaughney :EKraus :6 1oM :RECu-n-ningha-m

DATE: 5/01/91 :5/ 9 : 5/01/91 :5/02/91 :5/16/91 : 5/91 :6/ /91


* ,. or


the appropriate individuals to identify and report deviations to responsiblecompany officers. The responsibilities of company officers should be described;that is, to evaluate and report deviations to purchasers, and to inform theNRC of defects within the required time frames. Licensees should evaluatetheir own programs and develop procedures appropriate for their activities.

Manufacturers or suppliers who provide licensees with basic components thatcontain, or are used with, radioactive material, would normally need moreextensive procedures to assure proper identification and reporting of defectsthan customers who do not supply components to others.

These procedures should contain as a minimum, the following:


2. Directions to analyze the effect of the deviation in a basic component ifused by a licensee.

3. Directions to reach a conclusion based on the analysis as to whether thedeviation could create a substantial safety hazard.

Licensees are subject to inspection for compliance with 10 CFR Part 21, as wellas other applicable NRC requirements, and may be subject to enforcement actionfor noncompliance. This information notice does not require any written responseto NRC. If you have any questions about this matter, please contact theappropriate NRC regional office, or this office.


Technical Contact: Cheryl A. Trottier, NMSS(301) 492-3422




OFFC: IMOA : IMOB : IMA!'{ : IM : NMSS : IMNS : IMNS

NAME: CTrohtier/ll:JHickey : JGlenn :Crl aFey :EKraus :GSjoblom:RECunningham

DATE: 5/l /91 :5/ /91: 5/\/91 :5/V/91 :5/ /91 : 5/ /91 :5/ /91


Documents

NRC Information Notice 1991-039: Compliance with 10 CFR Part … · 2012. 11. 18. · to be a defect, and NRC was not notified of the defect, as required by 10 CFR 21.21(b). A contributing