ML20203F221

Responds to 970924 e-mail Re Issue of Whether Engineering Being Practiced in Review & Approval of Equipment & Facilities During Matls Licensing Process

ML20203F221
Person / Time
Issue date:	02/09/1998
From:	Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Frazee T WASHINGTON, STATE OF
Shared Package
ML20203F226	List: ML20203F221
References
NUDOCS 9802270232
Download: ML20203F221 (11)

Text

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• 4 UNITED STATSS 0 B NUCLEAR REGULATORY COMMISSION

• 'I nowiwarow, o.c. soonwooi 4....,* February 9, 1998 Mr. Terry C. Frazee, Heed Radioactive Material Section Department of Health Airdustrial Contar Building W5 F .O. Box 47827 Olympia, WA 98504 7827

Dear Mr. Frazee:

This is in response to your E mail of September 24,1997 regaroing the issue of whether '

engineering is being practiced in the review and approval of equipment and facilities durir.g the materials licensing process. In youi E mail, you requested 6 response to four questions. The response to one question was provided to you by telephone conference between yourself and Ms. Cardella Maupin of my staff. The responses to the remainlrig three questions are discussed below.

1. Under what Title, chapter and sectien of the CFR is " engineering" review vequired of an Agreement State?

Response

Except for provisions for specific engineering input for uranium mill impoundments, low-level waste sites and SSAD evall,ations, there is no specific section of 10 CFR which requires Agreement States to conduct an engineering review. However, our experience has shown that engineers or perst ns with equivalent training are necessary in order to properly evaluate applications requesting use and/or registration of radioactive sealed sources and devices, certain incident investigations (e.g., bracytherapy wire failure, broken source rod failures, etc.) and certain licensing actions.

l For example,10 CFR 34.20 states that an engineering analysis may be substituted for actual testing of a device. It is the reviewers / inspectors responsibility to ensure that the engineering analysis is acceptable; therefore, reviewers / inspectors must have proper training and education to perform the review. An engineering review is necessary to make the determination that a sealed source is encapsulated in a material resistant to corrosion as required by 10 CFR 36.21. Part 30.32(g) of 10 CFR sates that, 'An application for a specific license to use byproduct material in the form of a sealed source or in a device that contains the sealed source must either, (1) Identify the source or device by manufacturer and model number as registered with the Commission under Section 32.210 of this chapter or I with an Agreement State; or j (2) Contain the information identified in Section 32.210(c)."

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j Tony C. Frazee 2-l Part 32.210(c) of 10 CFR requires information, such as, prototype testing, quality )

l assurance and quality control, maintenance, and operating and safety procedures. This j

information, typically associated with engineering reviews and analyses, is necessary in l l order to perform a safety evaluation.  ;

m 3

Other areas which should involve an ' engineering review' are found in 10 CFR 36.33(a)(1) and 10 CFR 36.39.

2. !f a scaled source and device (SS&D) licensee uses a licensed professional engineer (PE) (whether in-house or an outside consultant paid by the licensee), is a second 4

independent PE review by the State required? '  ;

l l Mesponse:

In accordance with the current guidance for the Integrated Materials i t Performer'ce Evaluation Program (IMPEP) for SS&D evaluation and approval progrsms, there is no requirement for reviews to be performed by a PE. >

> However, an initial arid concurrence review of the licensee's st.bmittal should be made by the Sta^e to meet thi provisions of the IMPEP criteria under, " Technical i Quality of the Product Evaluanon Program." I have enclosed a copy of page 33 l of the final version of Management Directive 5.6, which describes the second

' concurrence' review.

Although the IMPEP criteria under this indicator do not require these reviews to be i

conducted by a PE, the reviewer is required to have specified technical training. The IMPEP criteria provide that SS&D evniustion staff should have a bachelor's degree or i equivalent training in the physical and/or life sciences, in addition, SS&D reviewers should be able to: (1) understand and interpret, if necessary, appropriate prototype [

tests which ensure the integrity of the products under normal, and likely accidental,  :

j conditions of use; (2) understand and interpret test results; (3) read and understand i blueprints and drawings; (4) understand how the device works e.nd how safety features ,

operate; (5) understand and apply the appropriata regulations l.(6) understand the conditions of use; (7) understand extemal dose rates, source activities and nuclide ,

chemical form; and (8) understand and utilize basic knowledge of engineering materials and their properties. ,

i .

3. Do you agree with or wish to modify our statement concoming the " practice of engineering" versus the role of health physics as stated above? (it is our contention that we perform or practice health physics and review the engineering work of others.

. We assert that only creative engineering work requires the PE's approval and that is '

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accomplished by the licensee or applicant when needed.)

Response:  ;

. Although the majority of the work in material licensing involves health physics

_ practices, some license reviewers must have engineering expertise in certain l

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i Terry C. Frazee - 3 areas. This includes, for example, engineering expertise in order to confirm analyses of shielding designs, SS&D reviews, and material's evaluation, as well as the engineering analyses you mentioned in your E mail related to low level webte and uranium recovery, ,

We hope this adequately responds to your questions. If you require additionalinformation,

- please contact me or Cardelia Maupin at (301) 415 2312. l l

ncerely, Vh Paul H. d'ohaus, h

puty Director Office of State Programs

Enclosure:

As stated W

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1, Terry C. Frazee 3- TEB se areas. This includes, ,'or example, engineering expertise in order to confirm analyses of shielding designs, SS&D reviews, and material's evaluation, as well as the engineering analyses you mentioned in your E mail related to low level waste and uranium recovery.

We hope this adequately responds to your questions, if you require additionallnformation, please contact me or Cardelia Maupin at (301) 415 2312.

Sincerely, Original Signed D/:

PAUL H. LoHAUS Paul H. Lohaus, Deputy Director Office of State Programs Enclor,ure:

As attited DistributiOD:

DIR RF (7S255) DCD (SP08)

SCDroggitis PDR (YES/)

LBolling CHackney, RIV DSollenberger, APSO LMcLean, RIV JHornor, RIV/WC Washington File DOCUMENT NAME: G:\ CHM \ ENGINEER.WA *See previous concurrence.

to m . ew w w. a.ewn.ni. meem. w in, w c cm .m .=cn-e.ne=>... r . em .im .ucn-v.e.<. v . No em OFFICE OSP l OSP:DD l NMSS/IMNS OGC l OSP:D o NAME CHMaupin:nblgd/nb PHLohaus DCool FXCameron RLBangart// 2/

DATE 10/24/97* 10/24/97*- 12/24/97* 02/03/98* //98

02gV 11/20/97* 12/03/97*

12/01/97*

OSP FILE CODE: SP AG 29_

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Volusse 5, Governmental Relations cod Public Affairs Integrated Materials Perf;rinance Evaluati:3 Program (IMPEP)

Handbook 5.6 pan III i

I Non-Common Performance Indicator 1-I4gislation and Program Elements Required for Competibility (F)(continued)

Category N (4) l Not applicable.

I Non Common Performance Indicator 2-Sealed

Source and Device Evaluation Program (o)

) Tbchnical Quality of the Product Evaluation Program (1)

! Satisfactory (a)

• Review cif a representative sample of SS&D evaluations completed during the review period indicates that product evaluations are thorough, complete, consistent, of acceptable technical quality, and I

adequately address the integrity of the products in use and likely

accidents. (i) l e Health and safety issues are properly addressed. (ii) e All initial and concurrence reviews 2 are performed by penons l

! having adequate training. (iii) l '

• All registrations clearly summarize the product evaluation and provide license reviewers with adequate information to license

possession and use of the product. (iv)

• De6ciency letters clearly state regulatory positions and are used at the proper time. (v) e An independent technical review of the application and proposed certificate of registration is performed by a second indhidual and supports the finding that the product is acceptable for licensing purposes.

techalid reviewer (It must is important concur with to the keep in mind initial review.) (vi that the indep)e s Applicable guidance documents are followed, unless approval to a use alternate procedures is obtained from managetaent. (vii) 8A eneeurtenes rev6ewlaelu and the doewerses generene by the ininal esrenewer.en independent asshaient The concurrense towewinclum4ew of the es evaluation unsterials.subanined of each area by n rewswis not to es the e a act w e ry 7e'#ie:'&M" C,'s.Te".".q,::".".lt:C"", -

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e Approved: (Draft 9/8/97) 33 1

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Terry C. Fraree 3-areas. This includes, for example, engineering expertise in o,1er to confirm analyses of shleiding designs, SS&D reviews, d material's evaluation, as well as the engineering analyses you mentioned in your E ait related to low level waste and uranium recovery.

We hop 9 this adequately responds to your q estions. If you require additionalinformation, please contact me or Cardelia Maupin at (30 ) 415-2312.

Sincerely, Paul H. Lohauc, Deputy Director Office of State Programs

Enclosure:

As stated Distribution:

DlR RF (7S255) DCD SP08)

SCDroggitis PDR ( ES./)

LBolling DSollenberger, APSO JHornor, RIV Washington File .

DOCUMENT NAME: G:sCHM\ ENGINEER.WA 'See p e I s erfncurrence.

to r.e.i . . eor or tw. oocum.ni. inoie.i. ic es. den; e . copy etnout n.ewm.av.e.ur. c . con, min it.cn ei _ _ _ g4 y . No eccy OFFICE OSP l OSP:DD NMSS/IMNS ipGC OSP:D NAME CHMaupin:nb/gd/nb PHLohaus DCool FXClimeron l RLBangart DATE 10/24/97' 10/24 & 12/3/97* 12/24/97* $1/48 01/ 98

,.l IOSP FILE CODE: SP AG 29 i)

Terry C. Frazee o3-includes, for example, confirm tory engineering analyses of shielding designs, SS&D reviews, and material's valuation, as well as the engineering analyses you mentioned in your E mail rehted to low-level waste and oranium recovery.

We hope this edequately responds to your quos 'ons, if you require additionalinformation, please contact me or Cardella Maupin at (301) 4 5 2312.-

Sincerely, 1

s au! H. Lohaus, Deputy Director ice of State Programs

Enclosure:

As stated l

l Distribution:

DIR RF (7S255) DCD(SP 8)

SCDroggitis PDR(YES )

LBolling DSollenberger, APSO JHornor, RIV Washington File DOCUMENT NAME: G:tCHMtENGINEER.W)A *See provi s concurrence.

to c*. . c , e em e.co % % in m. we c ,an ,w neuev.new. r . con. .n.enm.ev.nc e. r =

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Terry C. Frazee 3

. , r includes, for example, confirmatory engineering analyses of shielding designs, ,

SS&D r6 views, and material's evaluation, as well as the engineering analyses "

you mentioned in your E mail related to low-level waste and uranium recovery.

W hope this adequately responds to your questions, if you require additionalinformation, pies contact me or Cardella Maupin at (301) 415 2312.

Sincerely, Paul H. Lohaus Deputy Director Office of State Programs

Enclosure:

As stated 4

Distributlory DIR RF (7S255) DCD (SP08)

SCDroggitis R (YES/)

LBolling DSollenberger, APSO JHornor, RIV Washington File DOCUMENT NAME: G:\ CHM \ ENGINEER.m See pre us concurrence.

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OFFICE OSMR l QR$D()Il?li NMSS/IMNS OSP4 l l NAME CHMaupinM6/g4/14(% PHLbhaus' '

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~ OSP E CODE: SP AG 29

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Tctry C. Frazee 3-

3. Do you agree with or wish to modify our statement concerning the " practice of engineering" versus the role of health physics as stated above? (It is otyhontention that we perform or practice health physics and review the engineerinpork of others. ,

We assert that only creative engineering work requires the PE's ap oval and that is accomplished by the licensbe or applicant when needed.)

Response: Although the majority of the work in materialli nsing concerns health physics practices, we perform engine ing work in some areas. This includes, for example, confir tory engineering analyses of shielding designs, SS&D re ws, and materiars evaluation, as we!! as the engineering nalyses you mentioned in i your letter related to low level waste nd uranium recovery.

We hope this adequately responds to your questions. you have any additional questions, I can be reached at (301) 415 2326.

Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs Enclesure:

As stated

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Qittribution:

DIR RF (7S255) [, M G DCD (SPOS)

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Re'/!:: "rece &r::=

-g- > Apgg Washington File 1 IMG,2 Fiie DOCUMENT NAME: G:tCHMtENGINEER.WA *See previous concurrence, To receive a cop i of this document, Ind6ctte lathe bor *C"

• Copy wohout attachment / enclosure T o Cop r wnh attachment' enclosure '90 s No copy OFFICE %MP\\ 9th'[ OSP;DD l NMSS/IMNS OSP.D l NAME CM &jpin:ntalgd/kk PHLohaus _

DCOOL RLBangart DATE 10/24/97* 10/24/97* 11/ /97 11/ /97 . , ,

OSF FILE CODE: SP AG 29 SP R.12, SP l+2

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,, ,- m Mr. Terry C. Frazee 2- .,  ;

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. Although the IMPEP criteria under this indicato do not require L

,e these reviews to be conducted by a PE, there re requirements ..

l, / for technical training. The IMPEP criteria pro de that SS&D evaluation staff should have a bachelor's de ee or equivalent training in the physical and/or life sciences, addition, SS&D - r reviewers should be able to: (1) understan and interpret, if .

necessary, appropriate prototype tests whi h ensure the integrity of the products under normal, and likely a idental, conditions of

• use; (2) understand and interpret test res its; (3) read and understand blueprints and drawings; (4)pnderstand how the device works and how safety feattires operate; (5) understand and apply the appropriate regulations; ) understend the conditions of use; (7) understand ext al dose rates, source activities and nuclide chemical form; nd (8) understand and utilize basic knowledge of engineerir materials and their properties.

3. Do you agrea with or wish to modify our staterne t concerning the " practice of engineering" versus the role of health physics a stated above? (It is our contention that we perfor n or practice health physics and eview the engineering work of others.

We assert that only cientive engineering work equires the PE's approval and that is accomplished by the licensee or applicant wh n needed.)

Response: Although the majority of the ork in materiallicensing concerni, health physics practices, we. rform engineering work in some  !'

areas. This includes, for e mple, confirmatory engineering f

analyses of shielding desi s, SS&D seviews, and material's evaluation, as well as the ngineering analyses you mentioned in your letter releted to low evel waste and uranium recovery.

We hope this adequately responds to your q estions, if you have any additional questions, I can be reached at (301) 415 2326.

Sincerely, Paul H. Lohaus, Deputy Director

{: ~

Office of State Programs

Enclosure:

L e As stated ,

.e . Distribution:

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1 EXECUTIVE TASK. MANAGEMENT SYSTEM

<<< PRINT SCREEN UPDATE FORM >>>

TASK # - 7S255 DATE- 09/30/97 m --------

MAIL CTRL. - 1997 TASK ..STAR'.iED - 09/30,'97 TASX DUE - 10/13/97 TASK COMPLETED -

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/ /

TASK DESCRIPTION

- ENGINEERING REVIEW REQUESTING OFF. - WA REQUESTER - FRAZEE WITS - 0 FYP

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.... ... . . .. ~~ .

PROG - CHM PERSON - STAFF LEAD - CHM PROG.

AREA -

PROJECT STATUS -

OSP DUE DATE: 10/13/97 PLANNED ACC. -

N LEVEL CODE - 1 1

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