ML20125D160
| ML20125D160 | |
| Person / Time | |
|---|---|
| Site: | 07100210 |
| Issue date: | 09/24/1979 |
| From: | Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | Gossick L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20125D163 | List: |
| References | |
| RTR-REGGD-07.XXX, RULE-PRM-71-7, TASK-OS, TASK-TP-821-3 NUDOCS 8001140133 | |
| Download: ML20125D160 (6) | |
Text
-
- Hf g p o8,
! b UNITED STATES 8' .Q NUCLEAR REGULATORY COMMISSION g .*c N/ ,: C WASHINGTON, D. C. 20555 l
?; J SEP 2 41979 :
PRM 71-7 MEMORANDUM FOR: Lee V. Gossick Executive Director for Operations i FROM: Rcbert B. Minogue, Director Office of Standards Development {
t i
SUBJECT:
DENIAL OF PETITION TO REMOVE APPENDIX E (QUALITY ASSURANCE }
CRITERIA) 0F PART 71 AND LETTER TO DOT RECOMMENDING ADDITION ;
'~
0F QUALITY ASSURANCE REQUIREMENTS FOR PACKAGES CONTAINING RADI0 ACTIVE MATERIALS t
Enclosed for your signature are: (1) a letter to Walter P. Peoples, Jr., j President, Non Destructive Testing Management Association, setting out the 1 grounds for denial of his petition requesting the Commission to remove Appendix E - Quality Assurance Criteria for Shipping Packages for Radioactive Material - to 10 CFR Part 71 (Enclosure A), (2) a Federal Register Notice of denial of petition for rulemaking (Enclosure B), and (3) a letter to the Depart-ment of Transportation (DOT) recommending adding in 00T regulations the same ,
requirements for quality assurance (QA) programs for packages containing radio- i active material now required in NRC regulations (Enclosure C).
The petition was submitted by letter dated May 10, 1978 by the Non Destructive ;
Testing Management Association, P.O. Box 1214, Magnolia Park Station, Burcank, California and by seven undesignated radiography camera manufacturers and six l g
undesignated source nanufacturers. The petitioners requested that the Commission .
(1) revoke Appendix E - Quality Assurance Criteria for Shipping Packages for Radioactive Material - to 10 CFR Part 71, and (2) delay the effective date of g implementation of Appendix E until a hearing could be conducted. The peti-tioners stated that the basis for their petition was ". .the rule was forced fg on the industry and not discussed nor did the Commission attempt to notify two- a thirds of the manufacturers in this specific area of its attempt to create an l almost insurmountable and expensive paperwork program." The petitioners further !
noted that there was a lack of uniformity in quality assurance requirements !
between Agreement State licensees and NRC licensees. i A notice of filing of petition, Docket No. PRM 71-7, was published in the i Federal Register on June 14, 1978 (43 FR 25749). Thirty-nine persons submitted j comments. lhirty-two persons either suported the petitioners or asked for i revocation of Appendix E to 10 CFR Part 71. Of the 39 commenters, twenty-eight ;
felt that there was a lack of justification for Appendix E QA programs, twenty- ;
seven cited large costs and expensive paperwork associated with these QA require-ments, and fif teen persons felt the industry was not consulted and the re ulatory '
requirements were forced on the industry.
9002114 ;
i 8 0 01140 / M l t
, a n L' }
Lee V. Gossick 2 SEP 2 41979 l
The implementation date, i.e., the date by which licensees had to file descrip-tions of their QA programs with the Commission was extended from the original date of July 1, 1978 to January 1, 1979 as a result of the petition, PRM 71-7, and several letters which were received just prior to the original date. The staff concluded that further extensions of the implementation date or a hearing on the subject were unwarranted.
After careful consideration of the petition, the public comments thereon, and the facts related to the promulgation of the regulation, the staff concluded that: (1) the record shows that both the proposed rule and the effective rule were published in the Federal Register inviting public comments, and the Commis-sion did attempt to notify affected persons; (2) requiring that licensees have an effective QA program for packaging and transportation will improve safety; (3) the paperwork associated with the QA requirements for transportation is not overly expensive or insurmountable; and (4) although there is some nonuniformity in the requirements for packaging and transportation imposed on NRC and Agree-ment State licensees, the differences are not large and are being eliminated.
A detailed analysis of the petition and public comments thereon are presented in the enclosed Federal Register Notice (Enclosure B).
The letter (Enclosure C) to Mr. L. D. Santman, Director of the Materials l Transportation Bureau of the Department of Transportation (DOT), prepared for your signature, recommends DOT add quality assurance (QA) requirements to their regulations for packagings containing radioactive materials. Inspection surveys show a sizable percentage of packages in transport are not in full compliance with DOT requirements. The purpose of this recommendation is to extend QA requirements to all packagings containing radioactive material and to produce uniform QA requirements for all shippers of radioactive material. This would encourage greater diligence on the part of the persons involved to ensure that all types of packagings for radioactive material are designed, manufactured, ,
tested, used, maintained and repaired in accordance with all regulatory require- l ments, design requirements, package specifications and conditions of package approval. This appears to be a reasonable and effective means to maintain a j high level of safety, coincident with the increasing numbers of shippers, with-out imposing undue inspection and compliance efforts on the NRC and its licensees.
The letter to DOT contains the following specific recommendations:
That DOT require QA programs for all types of packagings fer radioactive materials, including those for low specific activity materials and type A ,
quantities of radioactive material; but encouraging the use of a " graded '
approach" in the establishment of these programs. As is the case with !
package designs, review and prior approval of QA programs for other than !
type B, large quantity or fissile material packagings would not be '
required.
However, consistent with the present DOT requirements that package designs for type B, large quantity, or fissile material be reviewed and 90021144
- . - _ - . - m
. .s t
Lee V. Gossick 3 SEP 2 41979 l
l approved by the NRC, the descriptions of QA programs for these same packag-ings should also be reviewed and approved by the NRC, prior to first use.
The staff considers this necessary to achieve an adequate level of quality assurance and to provide consistency in the regulatory requirements for most shippers of radioactive material.
Since QA programs for packages for fissile material and type B quantities are already required and reviewed for NRC licensee-shippers, the review and appro-val of QA programs by NRC staff under DOT requirements is estimated to require only about 1 man year of additional effort on a one-time basis, and a much-reduced effort on a continuing basis.
The implementation of QA requirements by the DOT would deal with the questions raised in the petition concerning the lack of direct QA requirements for manu- !
facturers and licensees located in Agreement States. The'se recommendations are i consistent with the revised Memorandum of Understanding between DOT and NRC.
On this basis, I recommend you sign the letter to DOT.
It is my view that the petition for rulemaking (PRM 71-7) is of a minor non- ,
/
policy nature where the grounds for denial do not substantially modify existing i
/ precedent. In accordance with 10 CFR 1.40(o), I recommend you approve the pub- i lication of the enclosed Federal Register Notice for denial and the letter to the petitioner.
Following your approval, note that:
(1) Appropriate Congressional Committees will be notified of the denial ,
(Enclosure G), j (2) The Commission will be informed of the denial through the Weekly Report, l (3) The issuance of denial will be published in Nuclear Regulatory Commission Issuances, (4) No public announcement will be issued on this matter.
Coordination: The Offices of Nuclear Material Safety and Safeguards and Inspec-tion and Enforcement, and the Division of Rules and Records con-cur in this paper. The Office of the Executive begal Director I
90021145
v s ,e Lee V. Gossick 4 SEP 2 41979 has no legal objection. The Office of Public Affairs concurs that a public announcement is not necessary.
kIM. ))A. a Robert B. Minogue,Director g
Office of Standards Development
Enclosures:
"A" - Letter of Denial for PRM 71-7 "B" - Federal Register Notice "C" - Letter to DOT "D" - Value Impact Analysis "E" - Petitioner's Letter "F" - Petition Announcement (43 FR 25749)
"G" - Draft Congressional Letter "H" - Draft Guide (May 1, 1978)
"I" - Draft Guide (May 15, 1978)
"J" - Effective QA Regulations (42 FR 39364)
"K" - Extension of Implementation Date (43 FR 27174)
"L" - Comment Letters (39)
Approved for Publication Under 10 CFR 1.40(o), the Executive Director for Operations has been delegated authority to deny petitions for rulemaking of a minor or nonpolicy nature, where the grounds for denial do not substantially modify existing precedent. I have found that t.he enclosed denial is in this category and am proceeding to issue it.
OCT 2 1979 c/ ,g_ 'j Date ee V. Gossick Executive Director for Operations Task No. TP 821-3 ,
l 90021146 1
1
Lee V. Gossick 5 SEP 2 41979 Distribution:
LVGossick, ED0 RBMinogue GAArlotto RMBernero j RJJones DRHopkins RJDoda DNussbaumer, NMSS MMalsch, ELD JFelton, DRR WMMorrison, SD LBHigginbotham, IE GH3idinger, IE CEMacDonald, NMSS EEJakel, ELD Docket File (PRM 71-7)
PDR V SECY Central File SD Alpha File SD r/f l
90021147 b
- 7174 , , RU155 AND R2GULATIONS Done at WA.shington, D.C., th!.s 20th tioning the applienbility of these QA [6740-02 .
. day of June 13'18. requirernents to Agrectnent State 11- Title 13-Cor.servation of Power and !
censees. Also, the Commission h:s re.
No z.-The Animal :=d Plant lies!th In. \Yciar P.esources specuon se.-etce ha.s deter =ined that tha ce!ved requests to delay implernents.
docuc en does not contain a:.afor preposal tion of the Appendix E cr!Lerla, Cu.. * ?7.e2 l r : Der.,*.L _eHIRGY REGU-ree.uinne the preps.stion c! e innation The Cornmission !s 6 the process of Irn= set 3:atement under Executive Order LATORY COfAM155 ION, DEPART-lis21 ed OM3 Cine.Ist A.toi. Addressing the question of the appi!ca.
IA2NT C7 EMIRGY '
A. Sc.y,,.. , ,
. b!!1ty of these QA requirements to.
Acting Deputy Admir.istrctor, Agreement State licensees. Because of suscwiln A-CENitAL eutts
. ... . . .. )*c!crincryse rices, this effort, and having considered IDocket No. P. Mis.ts)
- Int Doc. is.174st n!ed 6.::.ta: 2:45mm1 other factors involved. the NRC has PART 1b-2UL25 REL, TING ..O r dete. mined that a delay of 6 months INV mlG^, TlONS in implementing the Appendix E crite.
WO-00 ria appears justified. A short.ter= Establishinent, F.anel Rule Title 10-Energy '~ delay will have no significant adverse
' effect on public health and safety be. AGENCY: Federt1 Energy Regulatory CHAPTER 1-NUCLEAR REGULATORY cause of existing spee!!ic QA provi. Commission. .
COMMISSICH sions in Part 71 and the requirement ACTION: Final rule.
for a QA program, which the staff im- SUM;.!ARY: This s=endment to the PART 71-PACXAGING OF RA0lo. pests for approval of pac's:ghts for regulat!ons of the Feders:1 Energy o - 1 ( or lon ACTIVE MAi2 RIAL FOR TR A N S- shjpp!ng it:adated fuel, high level Eyrjlater FORT AND TRANSPORTATICN OF n .ste, and pluton! urn. o, ccord.ngly, p d'a es rebg to brestinthm '
RA0;OAci!VE MAi RIAL UNDIR the Commission is amending its regu- of persens nnd matters suhJect to fu CERTAtH CONDITIONS lations by extending the date for f!!ing jurisdiction. The regdations adopted a description of a QA progTarn in today are intended to state clearly ihe f 71.51 to Jance.ry 1.1979. Commission's policy :.nd procedures
,xtens. ion .of
.: the implementet. s his amend' .ent re ntes for investigations':enducted under the r eriod for 0 Precr=m n e c uir e. Fact se
~
solely to procedural rn:tters, the Com statutes it administers.
'*"' mission has found that good cause ETTECTIV"E D ATE: June 14.1978.
A ,.i N c, .. .. <* S. . Tucle- ... -o.e.e,.iate.' exists for c:nitt!n; noti:e of proposid FOR FURT4ER INFORSU. TION *
. Commission. rd e = P.k b g. and public procedure con"~A AC"". '
ge*'y gg.' e"n,,.gy, .ni,'
thereen. Es unnecessart,. Since the Thomson vonStein. 205 North Cap-
~' " '~ ~ "-
r.mendr:ent relieves licensees ficm re. itol Street. WP.shm: ten. D.C. 004:5, SUbil.U.RY: The U.S. Nu:ler.: Re r.da. s,. .,.. . . . ,W ,,nd . e.- r e r 'atic s a"n* e"*'"s
- 202 275 1532.
tc.-- Cor-isskn extends un:!! Janu. .
}
ary'1,1959". the date for f!!1ng a de. In effect. it may become effective upon EACKGROUND: Ne t!,:e is hereb.v j s:riptien of a quPSty tssuran:e pro. ;ub'.!:stien b the F::rnAL Rr::s n. given that the r ederai :.nergy Regul:. .
gir.= for transp ort p Pur:uant to the Atcmi: Energy Act tory Ccmmission (the Ccmm!!sion) .3 cririn21 deadline of ,w.ackages.y . 1.D-15. cf The 1954, as amended, the Energy Recr*
a"'...u--""~ , sow.w,
~ ~ ' *- *e- A of itle 18*
, e r e,.a. .. <. .._, gf.,e..t3 . .-. sg.
- u. .w. e .e..,..a. Cc.de r e:iera"l . .c. ,
- c. t e., ,. a .1.t..,o
.. sws.'.,.n,
- e. se.,,
t ab.
... r ,. , ..
...3.,,,-" .,
g:t.!:stion Act cf 1974. P.s arnended. .
... . n. .e. n e s. . .. s e . .u..
... ..i..
o . ,.;.f..s e ., .:"e
. . '"i n is n,o" .; '.-
. .*.~,;
. - -. .0' a.nd sectiens 550 and 553 cf T;tle 5 of to :.,vestigati ns, eff ective fr .:.edne.
re;uests fic= bteres:ed pe rens to the U.-Jted States Code, the feuct'bg ly.,,,he Com=issien hr.s tread autheri. ,
delay i=;ier.entation of the que.lity amendment to Title 10. Ch2.;ter I, t ;
- .:su.rance criteria. Code of Federal Regt:Mions. Par
- 1 ty to invest!gste matters subje:: to its g is pub!!shed as a document su. je ,. t jur:sdiction. Secticr.s 5tb). o(a). and 14 t E7'FICTIVI DATE: June 23.1972. .
of the Natural Ons Act. S Ts*-*' ectic..s ! ,
FOR FURT-IR INFORS!ATION cod!!! cation. . 205:b). 205( ) and 307. of tha i CONTACT: In } 71.51, parag :;hs (2) (b) and (c) Porer Act and Se: tion 12 cf the In. i are amend ed by deletbg "Jdy 1. *erstate Corniner:e Act all nuthe:.:e 1 '
Robert .T. Doda. Offf:e of Sts.ndards 39 8" and substituting therefor "Jznu. the Cor:=iss! n to investigt.te mr.qers Deve:c; ment. U.S. Nu:: ear Rer.ds. *IY I' ,' ITI.. *
- and persens subject to its juris'icu:n.
tory Cc: .miss!cn. W74hingicn. D.C.. Tcr enm;le, Se:tions !.if t.) of the 20555, phone 2 01 440-6910. -
gg,e,, 33, g;, 31, 3 s t; Pub.1. 23 003. ES-4!?: Naturt.1 Ons Act and 307(a) ci the 68 Stat. 930. $3*. S*5. 54E is Stat. 602 (4: Teder1] Por.er Act treadly auther,.:e f S., , P P. ,_ .-. . .. m. . . .._.3.v. , o 4rO w. . . e .~. O N. .
- , ..,. . " 17 ,_ .e' t* p.+ the Ccmmission te- p e.-,'ta,. . ,3 3 3 * . ,..C H2 E'st". ' EM On Au. r.::t 4.1977, the Nu ;eu Regu. ,- ,3.e
. ,. 3..t. ';
!atory C:m=ission pu Ushed effective *u- S . . . Innsunte :ny acts, eendit!:ns. prse. ;
, EI'*8 C' * ****#* "E I h I' **# dC '
t o_ ' * ' .*-
- r.a' .. '. ' c ns ' *.' .10 D:ted at Bethesdr., Md. this 21st day
.... . d . . . *. . . *.a . ..
4n .,
4 . . e s e .. +. . d . . .* . t3 ..-'. .
sar/ or pro er tn crirt to dete = r. I!"'e vn"e#"
th.
,,' *,, *" 13 78* er t.ny ;rrsen has virdsad er :s stout to m.
chu'.e d r. re"." ire =ent t.o fde f. de: rip. jg , ,..y prevain ,s c! this Act er :.ny ru9,
. k tien of a ::un: ty r.Munn:t (CA :r> 7.. . , , , , ., Co . reru;suen, or erf er there.: .ter, er to :M in 1
,. *g.,1 - tor *v -
- tam in!sf yini: the crite nn of .a r.?e . - - '
- mis -d e n." -
- g'g' the c.!er ement :: the =revisice.: c: th s l dix E by Jely 1.1973 H0 FR M50. Act er != ; resent:r. ru:es or re .::se:r.: ;
- thereunder. or in citr.nir.r it.fer= sten to :
. .n h o u g h ,'rt ;:: t . c or*.m e n '.s o r tU ; M.~s- - ,at V. Ooss rcE 1.c s t o .. . . e. ,.. .. .. .. ... .. .# .. ., ... v . -c . r . .. ...... .
." .; e .t !! <. :v .t *: e r
- t' r.
J 0#fVIII'f O!TC#!C* terve.*as I'i2- !'C P- a b4:s f.:t treer.=re.c.ne further '
N' Ed *C' M-
"ne Com: . ... n Mr "
. i.
- M! J In t.ddition. Sce:i:n IM!) cf the n.
.tters fre= int,;rund ;6.n:N ' .u.s. fyll O re. 3 .tt p : .* W e C.::.72: :: "i r.= 1 terstne Crrn=er:c Ac t. gives this .,
t init at FIC'5* t2, YOL. 4, H0. :22 77.1 AY, L%I 3,1774 e l
90021148
.