ML20216C192
| ML20216C192 | |
| Person / Time | |
|---|---|
| Issue date: | 03/05/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Daniel K NEW YORK, STATE OF |
| References | |
| NUDOCS 9803130319 | |
| Download: ML20216C192 (27) | |
Text
l Mr. Kenneth R. D nti, Jr., Deputy Director ,
+ b Cure:u of Radiological Health LMR - 5 1998 New York City Department of Health Two Lafayette Street,11th Floor New York, NY 10007
Dear Mr. Daniel:
As requested, we have reviewed the proposed transportation regulations, Section 175.02 Definitions and Section 175.105 Transportation and Packaging of Radioactive Materials, provided to us on January 30,1998. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Part 71. We also discussed our review of the regulations with Mr. Gene Miskin on February 9,1998.
As a result of our review, we have five comments that have been identified in the enclosure.
Please note that we are only providing comments on issues that we believe affect the j compatibility of your regulations. Under our current procedure, a finding that a State regulation meets the compatibility criteria of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we have determined that if your proposed regulations were adopted, incorporating the comments and without other significant change, they would meet the compatibility criteria as indicated in the OSP Intemal Procedure B.7.
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All l Agreement States Letter SP-96-027, "Reauest to HiahliaN Chanoes to Aareement State Reaulations Submitted to NRC for Compatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.
if you have any questions regarding the comments or any of the NRC regulations used in the ,
review, please contact me or Dr. Stephen N. Salomon of my staff at (301) 415-2322, or by Internet at SNS@NRC. GOV.
Sincerely, WginalSigned By:
E' PAULH.LOHAUS
$Mj$ [!!!f Paul H. Lohaus, Deputy Director PDR Office of State Programs
Enclosure:
((j l As stated t i kI Ca I
- p. Distributiqtrl:
\
[' SDroggitis PDR (YES/)
JMyers C? TO'Brien, ASPO ,.__.,,,_-.
b" C
BUsilton - ' ' ----*
NYC File i f, N 1 *See previous concurrence.
DOCUMENT NAME: G:\SNS\NYCTRANS.SNS T3 receive a copy of this docurnsnt. indicate in the box: "C" = Copy wdhout attachnent/ enclosure *E" = Copy with attachrnent/ enclosure "N" = No copy OFFICE OSP l OSP:DD [ OGC l OSP:D /l-l/ l NAME SSalomon:nb:gd PHLohaus FXCameron RLBangart ' M />
DATE 02/19/98* 02/19/98* 03/03/98* 0385/98 OSP FILE CODE: SP-AG-20-1 lI....c ll llllll l.l1 I1.1
\~
~
Kenneth R. D:nul, Jr., Deputy Di or
- Bure:u of Radiological Heilth New York City Department of Health
\
Two Lafayette Street,11th Floor New York, NY 10007
Dear Mr. Daniel:
As requested, we have reviewed the propo' sed transportation regulations, Section 175.02 Definitions and Section 175.105 Transportation and Packaging of Radioactive Materials, provided to us on January 30,1998. The redulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Part 71, We s'so discussed our review of the regulations with Mr. Gene Miskin on February 1998.
As a result of our review, we have fin comme that have been identified in the enclosure.
Please note that we are only providing comment pn issues that we believe affect the compatibility of your regulations. Under our current procedure, a finding that a State regulation meets the compatibility criteria of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we ha'ye determined that if your proposed regulations were adopted, incorporating the commentp and without other significant change, they would meet the compatibility c,iteria as indicatedin the OSP Intemal Procedure B.7.
\
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to uh for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Highlight Changes to Agreement State Regulations Submitted to NRC for Comam+ihility Review" (lyarch 1,1996), please highlight the 1 final changes and send one copy in a computer readsfole format, if possible. I If you have any questions regarding the comments or any of
\
NRC regulations used in the j review, please contact me or Dr. Stephen N. Salomon of my a ff at (301) 415-2322, or by Intemet at SNS@NRC. GOV. ,
1 Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs ,
l
Enclosure:
As stated Distnbution-DIR RF (8S-25) DCD (SP0Q SDroggitis PDR (YES()
JMyers TO'Brien, ASPO BUsilton NYC File
- See previous concurrence.
DOCUMENT NAME: G:\SNS\NYCTRANS.SNS T3 vece6ve e copy of this slocument. keslicebe in the hos: "C" e Copy without attachment /enclosu wWI rttachment/ enclosure "N" s No copy OFFICE OSP l OSP:DD l OGQ)V P OSP:D l \ l NAME- SSalomon:nb:gd PHLohaus FXCameron RLBangart i DATE 02/19/98* 02/19/98* 02/-) /98 02/ /98 \
,/) OSP FILE CODE: SP-AG-20-1 i
\
j 1
O a l
Mr. Kenneth R. Daniel Acting Director Bureau of Radiological Health New York City Department of Health
- Two Lafayette Street,11th Floor 4 New rk, NY 10007 I
Dear Mr. niel:
As requested, have reviewed the proposed transportation regulations, Section 175.02 Definitions and tion 175.105 Transportation and Packaging of Radioactive Materials, provided to us on uary 30,1998. The regulations were reviewed by comparison to the equivalent NRC regu tions in 10 CFR Part 71. We also discussed our review of the regulations with Mr. Ge Miskin on February 9,1998.
As a result of our review, have five comments that have been identified in the enclosure.
- Please note that we are onl oviding comments on issues that we believe affect the compatibility of your regulatio Under our current procedure, a finding that a State regulation i meets the compatibility criteria the equivalent NRC regulation may only be made based on a review of the final State regulatio However, we have determined that if your proposed regulations were adopted, incorpor ing the comments and without other significant change, they would meet the compatibility crit ria as indicated in the OSP Internal Procedure B.7. 3 4
We request that when the proposed reg tions are adopted and published as final regulations, a copy of the "as published" regulations rovided to us for review. As requested in our All Agreement States Letter SP-96-027, "Rea t to Hiahlicht Chanaes to Aareement State
~
Raantations Submitted to NRC for Comnatibilhu Review" (March 1,1996), please highlight the final changes and send one copy in a computer eadable format, if possible.
If you have any questions regarding the comments r any of the NRC regulations used in the review, please contact me or Dr. Stephen N. Salomo of my staff at (301) 415-2322, or by Internet at SNS@NRC. GOV.
Sincerely, Paul H. Lohaus, Dep ty Director ,
Office of State Progra
]
Enclosure:
As stated j Distnbution !
SDroggitis PDR (YES_f.__ N i JMyers TO'Brien, ASPO )
1 BUsilton i NYC File \
DOCUMENT NAME: G:\SNS\NYCTRANS
- c. %p, S[ l u . u . .- v . - .- ,r . . ,
OFFICE OSPS mb l OSI $ Wl OGC l OSP:D l l NAME. SSalomon:nb PHLohtu'g,' FXCameron RLBangart DATE 02/ 11 /98 02/M/98 02/ /98 02/ /98 OSP FILE CODE: SP-AG-20-1 1
1 a e d E8?
p i UNITED STATES g
.p j NUCLEAR REGULATORY COMMISSION WAsHWeGToN, D.C. 30086-0001
% March 5, 1998 Mr. Kenneth R. Daniel, Jr., Deputy Directur Bureau of Radiological Health New York City Department of Health Two Lafayette Street,11th Floor New York, NY 10007
Dear Mr. Daniel:
As requested, we have reviewed the proposed transportation regulations, Section 175.02 Definitions and Section 175.105 Transportation and Packaging of Radioactive Materials, provided to us on January 30,1998. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Part 71. We also discussed our review of the regulations 1 with Mr. Gene Miskin on February 9,1998. i As a result of our review, we have five comments that have been identified in the enclosure.
Please note that we are only providing comments on issues that we believe affect the compatibility of your regulations. Under our current procedure, a finding that a State regulation meets the compatibility criteria of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we have determined that if your proposed regulations were adopted, incorporating the comments and without other significant change, they would meet the compatibility criteria as indicated in the OSP Internal Procedure B.7.
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Hiahlicht Channes to Aareement State Reaulations Submitted to NRC for Comse,Li;tv Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible, if you have any questions regarding the comments or any of the NRC regulations used in the review, please contact me or Dr. Stephen N. Salomon of my staff at (301) 415-2322, or by Internet at SNS@NRC. GOV.
S' rely, .
)N !
} L ' b Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated
a i COMMENTS ON PROPOSED NEW YORK CITY REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Category Reaulation Reaulation Sublect and Comments B 175.02 and 71.4 Definitions 175.105(a)(5)
A number of definitions appear to have been omitted-Carrier, Licensed Material, Normal Form Radioactive Material, Fissile Material Package, Type B Package, I Packaging, Type A Quantity, and '
Type B Quantity.
These definitions are designated as category B, and should be adopted in Article 175 in an essentially identical manner to those of NRC.
B 175.02 71.4 Low specific activity (LSA) material !
The exponents for the average specific activity in LSA-l-(123)(1)(iv) .
and LSA-Ill-(123)(3)(iii) should be I negative instead of positive. These are apparently typographical errors.
B Omitted 71.83 Assumptions as to unknown properties This provision is designated category B and should be adopted in an essentially identical manner to that of NRC. An appropriate place to insert this provision is after Section 175.105(d)(1).
D 175.105(4) 71.0(d) Requirements for license i
Paragraph (ii) incorrectly cites NYC section 175.105(a)(4). Although this program element is Category D, not required for compatibility, the citation ,
should be corrected to avoid confusion.
B 175.105(f) Appendix A Appendix A-Determination of A1 to Part 71 and A2 The word " emitters" is omitted from paragraph V, apparently a typographical error.
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t a EXECUTIVE TASK MANAGEMENT SYSTEM
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STATUS - OSP DUE DATE: 2/20/98 PLANNED ACC. - N LEVEL CODE - 1 1
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/;) t uraoz LAURENCE F. FRIEDMAN, Ph.D., CHP
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f \ 1 Director Tus Crn or N Y ,
]I n et of Radiological Ilealth otranmzur or u i 12) 676-1556 (I G k Gd 90 f
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O IMMEDIATE O IMPORTANT Q ROUTINE O For your In'ormation/ files O Please see me O Please read O Discuss with oppropriate persons O Please comment Q Prepore for my signature O Please handle O And return Q Please investigate Q And inform me O Answer directly, with r py to me O Re Attoched REMARKS C .14 ( f 6 LUY ^
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i175.02 The indicated paragraphs of $175.02 are amended as follows:
{l75.02 Definitions. ,h 7[, y (a) As used in this Code, the following definitions shall apply:
O "A " means the maximum activity of special form radioactive material permitted in a T A package. "A 2" means the l (1) maximum activity of radioactive material, other than special forra. :=' :x..n LS A and SCO material, permitted in a Type A package. 'Ihese values are either IUted in Table 1, Appendix A of(175.105 of this Code or may be derived in accordance with the procedure prescribed in sucuppendix A.
[ (52) " Conveyance" means;-c:y cdSS, .... P., v.
!xt .. _._:.;;y _:_f. = __,da; naeb
', ' agh: : x., = hdd, .....r_ ...;;;, = d:En:d dxt c._ :f (1) For transoort by oublic hichway or rail any transoort vehicle or laree freicht container:
(2) For transoort by water any vesset or any hold. cumustnis. or defined deck area of a vessel includine any transoort vehicle on beard the vessel: and [
(3) For transoort by aircraft any aircrafi.
h (78) " Exclusive use" (also referred to in other regulations as " sole use" or ' full load") means tae sole use of a conveyance by a single consignor and for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consienor and the carrier must ensure that any loadine or unloadine is cerformed by oersonnel havine radioloeical trainine and resources anorooriate 'for safe handline of the consignment. The consienor must issue soecific instructions. in writine. for maintenance of exclusive use shioment controls. and include them with the shionine caner information orovided to the carrier by the consienor. [
(88) IDeleted]"9xi': d=dExS;' _. ._ i: n ;; .._.;; cf "xik E :x;! p__ ! ;x in:: := cf t: f;" .. : ; :'.._ L._x
_x:d!:; :: :': ; 5 ==':2 :: pxdd: ::A"::n!!:y xfry drin; ex r_.. :i---
(i) Ex-:k CEx ' ^ in'.:g: ' ? x.y 5: ex;p_ c' ^in x"-::s' xxtu: : d h xy ;nn;m;",
d r'? n;dn -
x5: nii_E:y af=y __....;b drin; . , : n ... . . p .. ' .d;.. = ::: ;x:,.;d f: px;; __ c' :x5; =;.E:y
.22:y 5:: x;y h x,_:xd i;- :sfx:: !:f:wnkx' O!) F-ik C!=: " ^. px'.;;; - 'ih x;y b .:_,_n:2 ::;.in ". :in pxb;n n =y c. .;....x' b;:, fx ni::xE:y 2- ', ' ::.ch. ".bi & : :: =O x :;;. _,_ .. _.._r dx :f 5 0. ";c 21..._.. . ng.; ;; ;in ..xbr "..xE:y 7
n f= 7 . _. . d dal:; . 4_..== ' diriin! px!a;x ;_y bx nxx,; 'nd:, :: kn ex ' : d :: .. . . i_: l 0.
ik Chr "' ^ :i:,.... .. :f pxt_y_ r '- Eh b _ .x" ' in n.xp; n_::= ty :pxit c:_.y.. ..; tr;;x: 6: ?.4,_. : d f
6; x c 0 p x vid: x b . n!.:x E:y nf=y.
h 89 (m..")'- ^" Fissile
^ material" means =y 4._2! xxb ; ..._...;' xx../: ; cf, _ _ 22. ':; := = .._.., P- S =' xx"ds.
plutonium-238, plutonium-239, plutonium-241, uranium-233, and-uranium-235 or any combination of these radionuclides. S^S :::::! = d:ph;d .:_..::r a Pdk .._.._t 9x 5 xxx 5 ;r: 6x"bd ' ;'75.P'
_xxd: ; :: 6: :- :25 ;;id :: pxvii :=k n! xE:y nf=y hi; :._c. r;;;.:-- Unirradiated natural uranium and 1 droleted uranium. and natural uranium or deoleted uranium that has been irradiated in thermal reactors only are not included in this dennition. Certain exclusions from fissile material controls are orovided in 10 CFR 71.53/ .
h (123) " Low specific activity (LSA) material" means radionctive material with limited soecific activity that satisfies the desenotions and limits set forth below. Shieldine materials surroundine the LSA material may not be considered in determinine the estimated averaee soecific activity'of the oackaec contents. LSA material must be in one of three erouns: [
(1) L SA.L /
(i) Orcs containine only naturally occurrine radionuclides (e e.. uranium. thorium) and uranium or thorium concentrates of such ores. or /
(ii) Solid unirradiated natural uranium or dcoleted uranium or natural thorium or their solid or liould comoounds or mixtures: or /
fiii) Radioactive material other than fissile material for which the A; value is unlimited: or [
CB (iv) Mill tailines (unimnineted earth. concrete. rubble. other debris. and activated >rGerial in which the radioactive material is ,
6j essentially uniformiv distnbuted. and the aversee specific activity does not excee#10k ' / - .,
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{2) LSA-fl. l (i) Water with tritium concentration un to 0 8 TBo/ liter (20 0 Ci/ liter): or [
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%f I fii) Material m which the radioactive material is distributed throuehout. and the averare soccific activity does not exceed 103 U A,/e for solids and cases. and2 10 A;/c for liouids. / ;
Page 1 of 17 l i
s
- il75.02 (3) LM-#I. Solids (e c.. consolidated wastes. activated materials) in which:
(i) The radioactive material is distributed throuchout a solid or a collection of solid obiects. or is essentially uniformiv distributed in a solid comnact bindine acent (such as concrete. bitumen. ceramie. etc.h and /
(ii) The radioactive material is relativelv insoluble. or it is intrinsically contained in a relativelv insoluble material. so that. even under loss of oackacing. the loss of radioactive material ocr oackace by leachine. when olaced in water for 7 days. would not exceed 0.1 Ae and /
-y (iiil The averace specific activity of the solid does not exceed 2x U(f
_,/c.=y ;f'h: fe!!n?ng:
g by
(!) unn h.= = 'h=! == =d phy;.x! = :h: mix' n:xt:ma of'h;x xx; '
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fn) un m d : d =;m! = &p!= d =n ;m = ::' _S= d : .; !^; = r; (ii;) == ::!& h q;2= n!=Fx pmdid ?: xx....._r; in net ==d !!! MS; (5.0 r "'=nx) pr """"c;
(! ) ==ca.! ' - Sh 'h: 9n= ny = --i"y = shy 1:"h;=d ad ' "? 'h: c: m=d mag:
x n... . in pc g. ... f x ': ^;in .1 =x:a -
(A) ' ' MBq (" 000! "" =m) :f :d'==Edx f= - Sh i: .^.2 quxty ; " ppxS: ^ ef l 75. ! 05 6 =' -- . 'ha LES GSq (0 05 ni);
(S; ' ' MSq (0 ^^5 r"! =m) :f:d!==!!da f= '? 'h; .^ 2 q;xty F ^.ppaf .^. cf !!75.!05 b m:n in ' E5 CSq ;" 05 ni), he ' -na in '7 CPq (! nm); =
- C) ' ^!Sq (0.2 "" =m) :' nf cudda fr -Sh 'h: .^.2 qux'hy F ^.pp=1; .* cf j! ?!? "' b m = ?- 2' CSq f+ etm+
(;; nhjn= c' n==f=== ==rm' ". :: m ' :=ur m.S; cf th= .: r===!, pmW&d i= ": nim.: =
nu! S n= ni!y S;p..:.ihk :nd i: 2:'=: x;tr 'n=:=, rt.= ;x=gd n.: a un f ' :q== r==, in n : nxd 2.' MSq' m2 (0 ^^^' ""b=k'C'*2) :' mix :':dx f "? ^: ^.2 q =ty F ^.pr.$: ^ af ; '75 ?"' S =: mm S= .
LS5 Sq (0 ^' xm), " .Sq/C'*2 (0.00! '"'=m!CM2) f= :in n.1x;dd=
h (144) " Package" means the packaging together with its radioactive contents as presented for transport.
(1)" Fissile material nackace" means a fissile material oackacine tocether with its fissile material contents.[
(2)"Tvne B nackace" means a Tvoe B nackacine tocether with its radioactive contents. On nooroval. a Tvoe B nackace desien is desicnated by NRC as B(U) unless the nackace has a maximum normal ooeratine oressure of more than 700 kPa (100 lb/ini cauce or a cressure relief device that would allow the ielease of radioactive material to the environment under the tests snecified in 10 CFR 71.73 (hvoothetical accident conditionst in which case it will receive a desicnation B(M) B(U) refers to the need for unilateral anoroval ofinternational shinments: B(M) refers to the need for multilateral nooroval ofinternational shinments. There is no distinction made in how nackaces with these desicnations may be used in domestic transoortation. To determine their distmetion for international transnonation. see USDOT reculations in 49 CFR Part 17L.& Tune _B oackace annroved before Sentember 6.1983. was desicnated only as Tvoe B. Limitations on its use are specified f 75.105(eg (21I) "Special form radioactive material" means radioactive material which satisfies the following conditions:
g (i) it is either a single solid piece or is contained in a scaled capsule that can be opened only by destroying the capsule;
- _ (ii) the piece or capsule has at least o e dimension not less than 5 mm.(0.197 inch); and
/ (iii) it satisfies the igHegtfre en'ts of 10 CFR 71.75.Ipecial form encapsulation designed in accordance with the i
k requirements of 10 CF 1.4 ' .in effect on June 30,1953,(see 10 CFR nart 71. revised as of January 1.1983L and constructed i
f prior to July I,1985, an special form encaosulation desicned in accordance with the reouirements of 10 CFR 714 in effect on
/ March 31.1996. (see 10 CFR nart 71. revised as of Januarv 1.1983t'and constructed before April 1.1998. may continue to be
' \7 used. ^ :px;.? 'n ==; x!== f a &dg=d = nn r==d dc .'un ?^, ' 0 =; m;= qumr:C ;f;pr:gmpF ,
appFxh': = S
- m: c: &;ig; r . n =Sn. Any other soecial form encansulation must meet the soecifications of this I definition. i h (228) " Transport index" means the dimensionless number, rounded up to the first decimal place, placed on the label of a package to designate the degree of control to be exercised by the carrier during transportation. The transnort index is determined alfollows, (1) For non-fissile material nackaces. the number determined by multiolvine the maximum radiation level in millisievert (mSv) ocr hour at one meter (3.3 fil from the externafsurface of the nackace by 100 (cauivalent to the maximum radiation lesel in millirem per hour at one meter (3.3 flik or /
(2) For fissile material nackaces. the number determined by multiolvine the maximum radiation level in millisievert ner hour at one meter (3 3 ft) from the external surface of the nackace by 100 (cauivalent to the maximum radiation level in millirem ner Page 2 of 17
e e .
s $175.02
/
hour at one er G.3 im. or. for criticality control oumoses. the number obtained as described in 10 CFR 71.59 whichever is larggt
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- Type A package" means a package that does not meet Type B package requirements.
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Page 3 of 37
.- , e il75.105(a)(1)
The existing $175.105 is repealed in its entirety, and the following is enacted in its place:
- . ll75.105 Transportation and Packaging of Radioactive Materials.
GeneralProvisions (a)I)(1) Purpose and Scope #
D(2) Records. /
(3) Completeness and accuracy of information.
pg/ - (4) Requirement for license. -
(5) Definitions.
(6) Transportation oflicensed material.
Exemptions l (b)D(1) Specific exemptions d(2) Exemption of physicians.
g(3) Exemption for low-level materials.
(c) GeneralLicenses (1) General license: NRC-approved package.
j (2) Previously approved package.
, (3) General license: USDOT specification container.
! (4) General License: Use of foreign approved package.
l (d) Operating Controls and Procedures i P I j (2) Preliminary determinations.l} Applicability of operating controls and procedures.
p( i l (3) Routine determinations.
(4) Air transport of plutonium.
(5) Opening instructions.
(6) Records.
p (7) Inspection and tests.
p (8) Reports.
g(9) Advance notification of shipment of irradiated reactor fuel and nuclear waste ;
and very large quantities of other radioactive material.
Quality Assurance (1) Quality assurance requirements.
, (2) Quality assurance organization.
(3) Quality assurance program.
j (4) Package design control.
) (5) Procurement document control.
(6) Instructions, procedures, and drawings.
(7) Document control.
(8) Control of purchased material, equipment, and services.
(9) Identification and control of materials, parts, and components.
(10) Control of special processes.
(11) Internal inspection.
(12) Test control.
(13) Control of measuring and test equipment.
(14) Handlint., storage, and shipping control.
J (15) Inspectic n, (16) Nonconforming test, parts, materials, and oroperating components. status.
(17) Correctiva action.
(18) Quality asetrance reords.
(19) Audits.
A d(pendix I) A-Determination ofAl and A2 1
, (a) General Provisions Q (1) Purpose and Scope (i) The regulations in this section establish requirements for packaging, preparation for shipment, and transportation of l licensed material. The packaging and transport oflicensed material are also subject to other sections of this code (e.g., fil75.03, 175.101) and to the regulations of other agencies (e.g., the U.S. Department of Transportation (USDOT) and the U.S. Postal I i
l Page 4 of 17 J
Q175.105(a)(2)
Service') having juris[dn over means of transport. The requirements of this part are in addition to, and not in substitution fo other requirements.
(ii) The regulations in this section apply to any person who delivers radioactive material to a canier for transport or transports radioactive material outside the confines of the person's facility and into any public area. No provision of this section authonzes possession oflicensed material. g/
}, f (2) Records.
q Each record required by this part must be legible throughout the retention period specified by each Department regulation. The j record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. g (3) Completeness and decuracy ofinformation.
(i) Information provided to the Department by an applicant for a license, or by a licensee, or information required by statute or by the Department's ' regulations, orders, or license conditions to be maintained by the applicant or the licensee must be complete and accurate in all material respects.[
i (ii) Each licensee shall notify the Department of information ident fied by the applicant or licensee as having, for the regulated activity, a significant implication for public health and safety or common defense and security. A licensee violates this requirement only if the licensee fails to notify the Department of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification must be provided to the Department within two working days ofidentifying the information. This requirement is not applicable to information that is already required to be provided to the Dephrtmer[t by other reporting or updating requirements. /
's&}f ab (4) Requirementfor license.
(i) Except as authorized in a general license or a specific license issued by the Department, or as exempted in this section, no person may-(A) Deliver radioactive material to a carrier for transport; or 7/'
(D) Transport radioactive material. y'
[ 7/, /O
~ ~ - _ k/ C5 g/J.
e (ii) Exemptions from the requirement for license in ms in<tn 4 e spec- 1 5.105(b)(3 General licen which no NRC package approval is required are issued in6175.105(c hroug 75.105 c
' 'The enerallicense 11_75.105(c)(l) requires that an NRC certificate of compliance or other package approval be issuco for the package to be used under tne gerieral g g license. The transport of licensed material or delivery of licensed material to a carrier for transport is subject to the operating
.( controls and procedures requirements of subsection (d) of this section, to the quality assurance requirements of subsection (c) of k i .jmd to the general provisions of subparagraph 16) of this section, including USDOT regulations referenced in 117 *~7/I A/
- 0) Depnitions.
The following terms are as defined here for the purpose of this section. These definitions are in addition to those in (175.02. To ensure compatibility with international transportation standards, all limits in this part are given in terms of dual units: The Intemational System of Units (SI) followed or preceded by U.S. standard or customary units. The U.S. customary units are not exact equivalents, but are rounded to a convenient value, providing a functionally equivalent unit. For the purpose of this part, either unit may be used.
h certificate holder means a person who has been issued a certificate of compliance or other package approval by the Commission. -
p Close repection by waice means immediate contact by water of sufficient thickness for maximum reflection of neutrons. [
Containment sysrem means the assembly of components of the packaging intended to retain the radioactive material durmg i transport. /
, h Low toxicity alpha rwitters means natural uranium, depleted uranium, natural thonum; uranium-235, uranium-238, thorium-l 232, thorium-228 or thorium-230 when cor.tained in ores or physical or chemical concentrates or tailings; or alpha emitters with I a half-hfe ofless than 10 days. V h Afarimum normal operating pressure means the maximum gauge pressure that would develop in the containment system in period of I year under the heat condition specified in 10 CyR 71.71(c)(l), in the absence of venting, external cooling by an ancillary system, or operational controls during transport. V
' Postal Service Manual (Domestic Mail Manual), section 124.3, which is incorporated by reference at 39 CFR 111.1.
I l
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il75.105(a)(6)
( h Natural thorium myes thorium with the naturally occurring distribution of thorium isotopes (essentially 100 weight percent thorium-232)a V h Optimum interspersed hydrogenous moderationycans the presence of hydrogenous material between packages that the maximum nuclear reactivity results. V Surface Contaminated Object (SCO) .means a solid object that is not itself classed as radioactive material, but which has radioacuve material distri uted on any ofits surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:
(1) SCO-1: A solid object on which: [
2 (i) The non-fixed contamination 2 on the accessible surface averaged over 300 cm (or the area of the surface 3 ifless than 300 cm'l does not exceed 2 4 Bq/cm (10' microcurie /cm') for beta and gamma and low toxicity alpha emitters, or 0.4 Bq/cm (10' microcurie /cm ) for all other alpha emitters; /
(ii) The fixed contamination on the accessible surface averaged over 300 cm' (or the area of the surface if less than 300 cm2 )
2 does not exceed 2 4x10' Bq/cm (1.0 microcuric/cm*)Jor beta and gamma and low toxicity alpha emitters, or 4x10' Bq/cm 2(0.1 microcurie /cm ) for all other alpha emitters; and [
(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 < m' (or the area of 2 2 the surface ifless than 300 2 cm') does not exceed 4= 10' Bq/cm (1 microcurie /cp1 ) for beta and gamma and low toxicity alpha emitters, or 4 = 10' Bq/cm (0.1 microcurie /cm*) for all other alpha emitters. (
(2) SCO-II: A solid object on which the limits for SCO-1 are exceeded and on which: #
(i) The non-fixed contamination 2 on the accessible surface averaged over 300 cm'(or the area of the surface 2 ifless than 300 c does not exceed 400 Bq/cm (10 2 microcurie /cm') for beta and gamma and low toxicity alpha emitters or 40 Bq/cm (10~
2 microcurie /cm ) for all other alpha emitters; / '
(ii) The fixed contamination on the accessible surface averaged over 300 cm' (or the area of the surface if less than 300 cm')
3 2 does not exceed Bx10' Bq/cm (20 microcuries/cm ) for beta and gamma and low toxicity alpha emitters, or Fx10' Bq/cm2 (2 l microcuries/cm') for all other alpha emitters; and l
(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of I 2 I the surface if less than 300 cm') does not exceed 8 x 10' Bq/cm (20 microcuries/cm') for beta and gamma and low toxicity alpha emitters, or 8 = 10' Bq/cm' (2 microcuries/cm') for all other alpha emittersy Uranium- natural, depleted, enriched /
(1) Natural uranium means uranium with the naturally occurring distribution of anium isotopes (approximately 0.711 weight )
percent uranium-235, and the remainder by weight essentially uranium-238).
(2) Depleted uranium means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes. 7 (3) Enriched uranium means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes. /
47l T S(i) Each person(6) Transpor/a"o" o!!icc"sca malcriat-who transports radioactive material outside the site of usage, or where transport is on public higha sys, or who delivers radioactive material to a carrier for transport, shall comply with the applicable requirements of the USDOT regulations in 49 CFR parts 170 through 189 appropriate to the mode of transport. /
(A) The person shall particularly note USDOT regulations in the following areas: /
(a) Packaging- 49 CFR part 173: Subparts A and B and I. [
(b) Marking and labelin Subpart D, 66172.400 through 172.40bil72.436 through 172.440, and subpart E. /g-49 CFR part 172:
(c) Placarding- 49 CFR part 172: Subpart F, especially fil72.500 through 172.519,172.556, and appendices B l and C. V (d) Accident reporting-49 CFR part 171: fil71.15 and 171.16 (e) Shipping papers and emergency information- 49 CFR part 172: Subparts C and G. / !
(/) llazardous material employee training- 49 CFR part 172: Subpart H. /
(g) Hazardous material shipper / carrier registration - 49 CFR part 107: Subpart G.
(B) The person shall also note USDOT regulations pertaining to the following modes of transportation:
l l
l Page 6 of 17 i
- e a il7f.105(b)(1)
(a) Rail- 49 CFR part 174: Subparts A through D and K. /
(b) Air- 49 CFR part 175. t/
(c) Vessel- 49 CFR part 176: Subparts A through F and M. /
(d) Public Highway- 49 CFR part 177 and parts 390 through 397.
(ii) If USDOT regulations are not applicable to a shipment of licensed material, the licensee shall confonn to the standards and requirements of the USDOT specified in ubsection (a) of this section to the same extent as if the shipment or transportation were subject to USDOT regulations. , .
(b) Exemptions
}Q (1) Specific exemptions On application of any interested person or on its own initiative, the Department may grant any exemption from the requirements of the regulations in this that it determines is authorized by law and will not endanger life or property nor the common defense and security.
g j& (2) Exemption ofphysicians.
l _
Any physician licensed by a State to dispense drugs in the practice of medicine is exempt fro (1175.105(h with respect to transport by the physician of licensegl.matenalfar use in the practice of medicine. However, any physician operating under this exemption must be licensed under {l7,5.103fthis code. Such transport must not be by public modes of transportation including, but not limited to,' trams, hmicabCcar services, trains, ferrys, or other means which would be returned immediately to public use after transporting licensed material. g
~7 y }& (3) Exemptionfor low-levelmaterials. o (i) A licensee is exempt from all requirements of this section with respect to shi radioactive material having a specific activity not greater than 70 Bq/g (0.002 pCi/ /pment or carriage of a (ii) A licensee is exempt from all requirements of this section, other than 175.10510y6) and 11"I ), with respect to shipment or carriage of the following packages, provided the packages con atn no fissile spaterial, or the fissile material exemption standards of 10 CFR 71.53 are satisfiep \
(A) A package containing no more than a Type A quantity of radioactive material; / 7/ )/rhf (B) A package in which the only radioactive material is low specific activity (LSA) material or surface contaminated objects (SCO), providedp external radiation level at 3 m from the unshielded material or objects does not exceed to mSv/h(I rem /h);or V '
(C) A package' transported within locations within the United States which contains only americium or plutonium in special form with an aggregate radioactivity not to exceed 20 curies. / ggf y 7j,67 (iii) A licensee is exempt from all requirements of this section, other thaail75165(0)(6) and l75.105(dMith respect to shipment or carriage of low-specific-activity (l.SA) material in group LSA4,^or'siirface contarE} mated obje SCO-1. ,
g h (c) General Licenses (1) Generallicense: NRC-approvedpackage.
(i) A general license is hereby issued to any licensee of the Department to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, certificate of compliance, or other approval has been issued by the NRC. F (ii) This general license applies only to a licensee who-[
(A) 11 part. +'74 quality assurance program approved by the Department as satisfying the provisions of sub (B) Has a copy of the certificate of compliance, or other approval of the package, and has the drawings and other.
documents referencedjn the approval relating to the use and maintenance of the packaging and to the actions to be taken j before shipment; g/ -
(
(C) Comphes with the terms and conditions of the license, certificate, or other approval, as applicable, and the applicable requirements of this section; and /
(D) Submits in writing to the Director, Office of Nuclear Materia Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, before the licensee's first use of the package; the licensee's name and license number and the package identification number specified in the package approval. V l
Page 7 of 17
(
L
I l
l
. Il75.105(e)(2) l I
! (iii) This general license applies only when the package approval authorizes use of the package under this general license. V (iv) For a Type B or fissile material package, the design of which was approved by NRC before April 1,1996, the general license is subject to the additional restrictions c}(2D i
(2) Previously approvedpackagef N (i) A Type B package previously approved by NRC but not designated as B(UlsB(M)(the identification number of the NRC Certificate of Compliance, may be used under the general license 6f 175.105(c)(tgwith the following additional conditions: %-
(A) Fabrication of the packaging was satisfactoril
.? ? A / b*
gust 31,1986, as demonstrated by application of its model number in accordance with5.105(d)(2)(iii),_ subparagrapl@ y camMa'ad (B) A package used for a shipment to a location outside the United tates is subject to multilateral approval, as defined l
in USDOT regulations at 49 CFR 173.403; and p
(C) A serial number that uniquely identifies each packaging which conforms to the approved design is assigned to, and legibly and durably marked c,n, the outside of each packaging. / g 7 f /g,,,,,
(ii) A Type B(U) package, a Type B(M) package, a low specific activity ( material package or a fissile material package, previously approved by the NRC but with6ut the gesignatio identification number of the NRC Certificate of Compliance, may be used under the general license Qf175.105(c)J( the following additional conditions:
(A) Fabrication of the package is satisfactojy enmplet_ed b number in accordance with subparagraptiT75.105(d)(2)(iii(y gg g(Q April 1,1999 as demonstr (B) A package used for a shipment to a location o tside the United States is subject to multilateral approval as defined in USDOT regulations at 49 CFR 173.403; and (C) A serial number which uniquely identifies cach packaging wh ch conforms to the approved design is assigned to and legibly and durably marked on the outside of each packaging. '
f (3) Generallicense: USDOTspecification container. f (i) A general license is issued to any licensee of the Department to transport, or to deliver to a carrier for transport, licensed material in a specification container for fissile material or for a Type B quantity of radioactive material as specified in USDOT regulations at 49 CFR parts 173 and 178/
(ii) This general license applies only to a licensee who has a quality assurance program approved by the Department as satisfying the provisions of subsection (e) of this section. y (iii) This general license applies only to a licensee who- y,
(A) Has a copy of the specification; and /
(B) Complies with the terms and conditions of the specification and the applicable requirements of this section.y (iv) This general license is subject to the limitation that the specification container may not be used for a shipment to a location outside the United Sta;es, except by multilateral approval, as defined in USDOT regulations at 49 CFR 173.403. y
Q[ (4) General License: Use offoreign approvedpackage. y,**
(i) A general license is issued to any licensee of the Department to transport, or to deliver to a camer for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate that has been revalidated by USDOT as meeting the applicable requirements of 49 CFR 171.12. / p (s///
(ii) Except as otherwise provided in this section, the general license applies _only to a heensee who has a quality assurance program approved by the Department as satisfying the applicable provisions of subsectionM of this section.
(iii) This general license applies only to shipments made to or from locations outside the United States.
(iv) This general license applies only to a licensee who-(A) Has a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in th certificate, relating to the use and maintenance of the packaging and to the actions to be taken before shipment; and l (B) Complies with the terms and conditions of the certificate andysvalidatienrand with the applicable requirements of this section. With respect to the quality assurance provisions offubsection (c)bf this part, the licensee is exempt from design, construction, and fabrication considerations. '
g I
Page 8 of 17
s ,, ,
il75.105(d)(1)
Operating Controls and Procedures f h (d) (!) Applicability ofoperating controls andprocedures.
J A licensee subject to this section, who, under a general or specific license, transports licensed material or delivers licensed material to a carrier for transport, shall comply with the requirements of thispubsection,.with the quality assurance requirements of subsection (e) of this section, and with the general provisions of subsectjo 175.105(0 this section.
(2) Preliminary determinations.
Q .Yl1 f7< Baere the nrsi use of any packaging for the shipmeni oriiceesed maieriai-(i) The licensee shall ascertain that there are no cracks, pinholes, uncontrolled voids, or ather defects that could significantly reduce the effectiveness of the packaging;[
(ii) Where the maximum normal operating pressure will exceed 35 kPa (5 lbf/in') gauge, the licensee shall test the containment system at an internal pressure at least 50 percent higher than the maxirrtum nohnal operating pressure, to verify the capability of that system to maintain its structural integrity at that pressure; and p,/
(iii) The licensee shall conspicuously and durably mark the packaging with its model nurnber, serial number, gross weight, and a package identification number assigned by the NRC. Before applying the model num - the licensee shall determine that the packaging has been fabricated in accordance with' the design approved by the NRC.
ff (3) Routine determinations.
Before cach shipment of licensed material, the licensee shall ensure that the package with its contents satisfies the applicable h requirements of this section and of the license. He licensee shall determine that-(i) The package is proper for the contents to be shipped; p,/
(ii) The package is in unimpaired physical condition except for superficial defects such as marks or dents; /
(iii) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects; r (iv)
Any the liquid; sy[ stem for containing liquid is adequately scaled and has adequate space or other specifie (v) Any pressure relief dcvice is operable and set in accordance with written procedures; [
(vi) The package has been loaded and closed in accordance with written procedures; [
(vi') Any structural part of the package that could be used to lift or tie down the kage during transport is rendered inoperable for that purpose, unless it satisfies the design requirements of 10 CFR 71.45; (viii) The level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable, and within the limits specified in USDOT regulations in 49 CFR 173.443; v' (ix) External radiation levels around the packagy and around the vehicle, if applicable, will not exceed the limits specified in 10 CFR 71.47 at any time during transportation;/
(x) Accessible package, surface temperatures will not exceed the limits specified in 10 CFR 71.43(g) at any time during )
transportation; and (xi) For fissile material, any moderator or neutron abscrber, if required, is present and in proper condition.
(4) Air transport ofplutonium.
Notwithstanding the provisiens of any general licenses and notwithstanding any exemptions stated directly in this part or
/
included indirectly by citation of 49 CFR chapter I, as may be applicable, the beensee shall assure that plutonium in any form, ,
whether for import, export, or domestic shipment, is not transported by air or delivered to a carrier for air transport unless:
(i) The plutonium is contained in a medical device designed for individual human application; or [
(ii) ne plutonium is contained in a material in which the specific activity is not greater than 74 Bq/g (0.002 mci /g) of material and in which the radioactivity is essentially uniformly distributed; or 2
(iii) and isThe plutonium shipped is shipped in accordance iq(a singtontkye containing no more than an A quantity of plutonium in an with 175.105(
l[
(iv) The plutonium is shipped in aMe specifically autborized for the shipment of plutonium by air in the Certificate of Compliance for that package issued by the NRC. / ,
N (LQ (v) For a shipment of plutonium by air which is subject to subparagraph (iv) of this paragraph, the licensee shall, through special arrangement with the carrier, require com ance with 49 CFR 175.704, U.S. Department of Transportation regulations applicable to the air transport of plutonium.
- Page 9 of 17
- e
., {l75.105(d)(5)
Opening instructions.
f (5)
O Before delivery of a package to a carrie cor transport, the licensee shall ensure that any rpecial instructions needed to safely ID operuhe package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with A A /7 6 $ k)
{, Q (6) Records.
(i) Each licemee shalbmaiatai , or a period of 3 years after shipment, a record of each shipment of licensed material not exempt und )dhowing where applicable-(A) Identification of the packaging by model number and serial number; 9 (D) Verification that there are no significant defects in the packaging, as shipped;#
(C) Volume and identification of coolant; [
(D) Type and quantity oflicensed material in each package, and the total quantity of each shipment; /
(E) For each item ofirradiated fissile material-(a) lientification by model number and serial number; #
(b) Irradiation and decay history to the extent appropriate to demonstrate that its nuclear and thermal characteristics comply with license conditions; and /
(c) Any abnormal or unusual condition relevant io radiation safety; /
(F) Date of the shipment; /
(G) For fissile packages and for Type B packages, any special controls exercised; /
(H) Name and address of the transferee; (1) Address to which the shipment was made; and [
(J) Results of the detenninations required 175.105 cDfA)- d by the conditions of the package approval.
(ii) The licensee shall make available to the Department for inspection, upon reasonable notice, all records required by this section. Records are only valid if stamped, initialed, or signed and dated by authori rson pr otherwise authenticated. V' (iii) The licensee shall maintain sufficient written records to fhma W Eiic'e orthe quahty of packaging. The records to be maintained include results of the determinations r quired by 75.105(d)(2 - sign, fabrication, and assembly records, results of reviews, inspections, tests, and audits; results of moniton r performance and materials analyses; and results of maintenance, modification and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability and the action taken in connection with any deficiencies noted. The records must be retained for three years after the life of the packaging to which they apply.
k (7) Inspection and tests.
(i) The licensee or certificate holder shall permit the Department, at all reasonable times, to inspect the licensed material, '
p packaging, premises, and fac lities in which the licensed material or packaging is used, provided, constructed, fabrMated, tested, stored, or shipped.
(ii) The licensee shall perform, and permit the Department to pe form, any tests the Department deems necessary or
( / appropriate for the administration of the regulations in this chapter.
S'7i& a> acrorts.
The licensee shall report to the Department within 30 days--
(i) Any instage in which there is significant reduction in the effectiveness of any approved Type B, or fissile, packaging during use; /
(ii) Details of any defects with safety significance irt Type B, or fissile, packaging after first use, with the means empicyed to repair the defects and prevent their recurrence; or /
(iii) Instances in which the conditions of appront in the certificate of compliance were not observed in making a shipment. 4---
(, f (9) Advance notification ofshipment ofirradiated reactorfueland nuclear waste and very large quantities of J other radioactive material.
(i) As specified in subparagraphs (ii), (iii) and (iv) of this section, each licensee shall provide advance notification to the govemor of a State, or the governor's designee, of the shipment of licensed material, through, or across the boundary of the Page 10 of 17
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,. e $175.103(d)(9)
State, before the transport, or delivp<6e a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage. V (ii) Advance notification is required under this section for shipments of irradiated reactor fuel in , stics less than that subject to advan e notification requirements of 10 CFR 73.37(f). Advance notification is also requireo under this section for shipment oflicensed material, other than irradiated fuel, meeting the following three conditions: /
(A) The licensed material is required by this part to be in Type B packaging for transportation; /
(D) The licensed material is being transported to or apco a State boundasy en route to a disposal facihty or to a collection point for transport to a disposal facility; and V (C) The quantity oflicensed material in a single package exceeds the least of the following:
(a) 3000 timys the A, value of the radionuclides as specified in appendix A, Table A-1 for special f)rm radioactive material; V (b) 3000 times the As v of the radionuclides as specified in appendix A, Table A-1 for normal form radioactive material; or (c) 1000 TBq (27,000 Ci).
(iii) Proceduresfor submitting advance nottfication.
(A) The notification must be made in writing to the office of each appropriate governor or governors designee and to the Department. f d
(D) A notification delivered by mail must be postmarked a ast 7 days before the beginning of the 7-day period during which departure of fhe shiprnent is estimated to occur.
(C) A notification delivered by messenger must reach the office of the governor or of the governor's designee t least 4 days before the beginning of the 7-day period during which departure of the shipment is estimated to occur.
(a) A list of the names and mailing addresses of the governors' designees receiving advance notification of transportation of nuclear waste was published in the Federal Register on June 30,1995 (60 FR 34306)#
(b) ne list vill published annually in the Federal Register on or about June 3 ta reflect any changes in information.
(c) A list of the names and mailing addresses of the governors' designees is available en request fr the Director, Office of State Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-000) .
(D) The licensee shall retain a copy of the notification as a record for 3 years /
(iv) Information to be furnished in advance notification of shipment. Each advance notification of shipment of irradiated reactor fuel or nuclear waste must contain the following information/
(A) The name, addre and telephone nurnber of the shipper, carrier, and receiver of the irradiated reactor fuel or nuclear waste shipment; (D) A description of the irradiated reactor fuel or nuclear waste contained in the shipment, as specified in the regulations of USDOT in 49 CFR 172.202 and 172.203(d); ,,/
(C) The pop of origin of the shipment and the 7-day period during which departure of the shipment is estimated to occar; V (D) %e 7-day period during which arrival of the shipment at State boundaries is estimated to occur; (E) The destination of the shipment, and the 7-day period during which arrival c:the stipment is estimated to occur; and;,, -
(F) A point of contact, with a telephone number, for current shipment information. V (v) Rcwsion notice. A licensee who finds that schedule information previously furnished to a governor or governor s designee, in accordance with this section, will not be met, shall telephone a responsible individual in the office of the governor of the State or of the governor's designee and inform that individual of the extent of the delay bey the schedule originally reported. The beensee shall maintain a record of the name of the individual contacted for 3 years.
I (vi) Cancellation notice.
(A) Each heensee who cancels an irradiated reactor fuel or nuclear waste shipment for which advance notification has been sent shall send a car)pellation notice to the governor of each State or to the governor's designee previously notified, and to the Department. /
Page 11 of 17 L .
e il75.105(e)(1)
(B) The licensee shall state in the notice that it is a cancellation and identifype advance notification that is being canceled. He licensee shall retain a copy of the notice as a record for 3 years. V (e) Quality Assurance (1) Quall'y assurance requirements.
(i) Purpose. This subpart describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, rnaintenance, repair, and modification of components of packaging that are important to safety. As used in this subpart, " quality assurance" comprises all those planned and systematic actions necessary to provide adequate' confidence that a system or component will perform satisfactorily in service. Quahty assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quahty of the matenal or e edetermined r uirem ts ngto *
(ii) Establishment ofpro ram Nadf/Iwe shall estahl% -M execu a uality assurance program satisfying each of the applicable criteriar 11175.105(e)(IMrougl@5.10$(e)(19M satisfying any specific provisions that are applicable to the licensee's activities incTuTmg procurement of packagmg. ine licensee shall apply each of the applicable criteria in a graded approach, i.e., to an extent that is consistent with its importance to safety.
I (iii) Approval ofprogram. Before the use of any package for the shiprnent oflicensed material subject to this subsection, each licensee shall obtain Department approval of its quality assurance program. Each licensee shall file a description of its quahty assurance program, inclujd' g a discussion of which requirements of this subpart are applicable and how they will be satisfied, with the Department./
(iv) Existmg package designs. The provisions of this paragraph deal with packages that have been approved for use in accordance with this part before January 1,1979, and which have been designed in accordance with the provisions of this part in effect at the time of application for package approval. Those packages will be accepted as having been designed in accordance with a quality assurance program that satisfies the provisions of subparagraph (ii) of this section (v) Existingpackages. The provisions of this paragraph deal with packages that have been approved for use in accordance with this part before January 1,1979; have been at least partially fabricated prior to that date; and for which the fabncation is in accordance with the provisions of this part in effect at the time of Splication for approval of package design. nese packages will be accepted as having been fabricated and ass bled in accordance with a quality assurance program that satisfies the provisions of subparagraph (ii) of this subsection.
(vi) Previously appmvedprograms. A Department-approved quality assurance program that satisfies the applicable criteria of Appendix B of 10 CTR Part 50, and that is established, maintained, ar.d executed with regard to transpon packages, will be accepted as satisfying the requirements of subparagraph (ii) of this paragraph. Before first use, the licensee shall notify the Depar*,nent of its intent to apply its previously approved Appendix B program to transportatioyctivities. The licensee shall idatify the program by date of submittal to the Department and date of Department approval. V fl& (2) Quality assurance organization.
) (i) ne licensee shall be responsible for the establish.nent and execution of the quality assurance program. The licersee may delegate to others, such as contractors, agent; or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. The licensee shall clearly establish and delineate, in writing, the authority and duties M persons and organizations performing activities affecting the safety-related functions of structures, systems, and components. Theseyetivities include performing the functions associated with attaining quality objectives and the quality assurance functions. V (ii) The quality assurance functions are-(A) Assuring that an appropriate quality assurance program is established and effectively executed; and /
(B) Venfying, by procedures such as chefc 'ng, auditing, and inspection, that activities affecting the safety-related functions have been performed correctly. v (iii) The persons jnd organizations performing quality assurance functions must have sufficient authority and organizational 7 freedom to- v 4 (A) Identify quality problems; (B) Initiate, recommend, or provide solutions; and
/
/
(C) Venfy implementation of solutions. /
(iv) The persons and organizations performing quality assurance functions shall report to a management level that assures that the required authority and organizational 1reedom, includmg sufficient independence from cost and schedule, when opposed to safety considerations, are provided. /
Page 12 of 17
f i
'
- e il75.105(e)(3)
)
' (v) Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that the persons and organizations assigned the quality assurance functions have the required authority and organizational freedom. [
(vi) Irrespective of the organizational structure, the individual (s) assigned the responsibility for assuring effective execution of I any portion of the quality assurance program, at any location where activities subject to this section are being performed, must ha c direct access to the levels of management necessary to perform this function. /
67 w/ o> wm~~e p~z~~ 7 M 78 (i) ne licensee shall establish, at the earliest practicable time consistent the schedule fnr -@hi the activities, a h quality assurance program that complies with the requirementsr;tiMI75.105(c) J througlf75.105(e document the quality assurance program t y written procedures or uhnus and shall carry vm & pugram in accordance with e liceusee shall
{
i those procedures throughout the period during wbch the packaging is used. The licensee shall identify the material and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.
(ii) The licensee, through its quality assurance program, shall provide control over activities affecting the quality of the identified materials and components to an extent consistent with their importance to safety, and as necessary to assure conformance to the approved design of each individual package used for the shipment of radioactive material. The licensee shall assure that activities affecting quality are accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The licensee shall take into account the need for special controls, processes, t uipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.
(iii) The licensee shall base the requirements and procedures of its quality assurance program on the following considerations concerning the complexity and proposed use of the package and its components: g (A) The impact of malfunction or failure of the item to safety; 7 (D) The design and fabrication complexity or uniqueness of the item; (C) ne need for special controls and surveillance over processes and equipment; #
(D) The degree to which functional compliance can be demonstrated by inspection or test; and V i (E) ne quality history and degree of standardization of the item.
(iv) The licensee shall provide for indoctrination and training of personnel performing activities affecting quality, as necessary i to assare that suitable proficiency is achuved and maintained. ne licensee shall review the status and adequacy of the quality l assurance program at established intervals. Management of other organizations participating in the quality assurance program '
shall review regularly the status and adequacy of that part of the quality assurance program which they are executing. y
})Q (4) Package design wntrol.
(i) The licensee shall establish measures to assure that applicable regulatory requirements and the package design, as specified in the license for those materials and components to which this section applies, are correctly translated into specifications, drawings, procedures, and instructions. These measures must include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from standards are controlled. Measures must be established for ui the related selection and functions cf the review materials, forand parts, suitability componentsof application of the packaging of materials, parts, eq/pment, and processes tha (ii) The bcensee shall establish measures for the identification and control of design interfaces and for coordination among participating design organizations. Rese measures must include the establishment of written procedu es, among participating design organizations, for the review, approval, release, distribution, and revision of documents involving design interfaces. The design control measures must provide for verifying or checking the adequacy of design, by methods such as design reviews, ahemate or simplified calculational methods, or by a suitable testing program. For the venfying or checking process, the licensee shall designate individuals or groups other than those who were responsible for the origmal design, but who may be frorn the same organization. Where a test program is used to serify the adequacy of a specific design feature in lieu of other verifying or checking processes, the licensee shall include suitable qualification testing of a prototype or sample unji under the most adverse design conditions. The licensee shall apply design control measures to items such as the following: V (A) Criticality physics, radiation shieldmg, stress, thermal, hydraulic, and accident analyses; y (B) Compatibility of materials; (C) Accessibihty for inservice inspection, maintenance, and repair; V l
Pagc 13 of 17
" ,.* e fl75.105(e)(5)
(D) Features to facilitate decontamination; and (E) Delineation of acceptance criteria for inspections and tests.
(iii) The licensee shall subject design changes, including field changes, to design control measures commensurate with those applied to the original design. Changes in the conditions specified in the package approval require the Department's hiproval. [
flt (5) Procurement document control.
p The licensee shall estehlish measures to assure that adequate quality is required in the documents for procurement of material, equipment, and services, whether purchased by the licensee or by its contractors or subcontractors. To the extent necessary, the licensee shall require contyr ctors or subcontractors to provide a quality assurance program consistent with the applicable provisions of this part.#
,jjl (6) Instmettons, procedures, and drawings.
The licensee shall prescribe activities afTecting quahty by documented instructions, procedures, or drawings of a type appropriate to the .circumstancer and shall require that these instructions, procedures, and drawings be followed. He instructions, procedures, and drawings must include appropriate quantitative or qualitative acceptance criteria for determining taat important activities have been satisfactorily accomplished.
ty7ll!B m oocument contra.
D
/
ne licensee shall establish measures to control the issuance of documents such as instructions, procedures, and drawings, including changes, which prescribe all activities affecting quality, nese measures must assure that documents, including changes, are reviewed for adequacy, approved for release by authorized personnel, and distributed and used at the location whey fe prescribed activity is performed. nese measures must assure that changes to documents are reviewed and approved. /
h ]f.ll& (8) Control ofpurchased material, equipment, and services.
(i) The licensee shall establish measures to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures must include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products on delivery /
(ii) The licensee shall have available documentary evidence that material and equipment conform to the procurement specifications before installation or use of the material and equipment. De licensee shall retain, or have available, this documentary evidence for the life of the package to which it applies. The licensee shall assure that the evidence is sufficient to identify the specific requirements met by the purchased material and equipment. v (iii) The licensee shall assess the effectiveness of the control of quality by contractors and subcontractors at intervals consistent l with the importance, complexity, and quantity of the product or services. p
~fl pllf (9) Identsfication and control ofmaterials, parts, and components.
ne licensee shall estabhsh measures for the identification and control of materials, parts, and components. These measures must assure that identification of the item is maintained by heat number, part number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, installation, and use of the item. Rese identification and l control measures must be designed to prevent the use ofincorrect or defective materials, parts, and coiaponents. y
} }{,llf (10) Controlofspecialprocesses.
The licensee shall establish measures to assure that special processes, including welding, heat treating, and nondestructive testing, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, s andards, specifications, criteria, and other special requirements. y (II) Internalinspection.
& )olNThe beensee shall establish and execute a program for inspection of activities affecting quality by or for the organization performing the activity, to verify conformance with the documented instructions, procedures, and drawings for accomplishmg the activity. He inspection must be performed by individuals other than those who performed the activity being inspected.
Examination, measurements, or tests of material or products processed must be performed for each work operation where necessary to assure quality. If direct inspection of processed material or products is not carried out, indirect control by monitoring processing methods, equipment, and personnel must be provided. Both inspection and process monitoring must be provided when quahty control is inadequate without both. If mandatory inspection hold points, which require witnessing or inspecting by the licensee's designated representative and beyond which work should not proceed without the consent of its designated representative, are required, the specific hold poir.ts must be indicated in appropriate documents. ,, -
f, } & (12) Test control.
The licensee shall establish a test program to assure that all testing required to demonstrate that the packaging components will perform satisfactorily in service is identified and performed in accordance with written test procedures that incorporate the requirements of this part and the requirements and acceptance limits contained in the package approval. De test procedures must Page 14 of 17
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l 4
e e c 9175.105(fM13) include provisions for assuring that all prerequisites for the given test are met, that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions. The licensee shall document and evaluate the test results to assure that test requirements have been satisfied. #
6 D
}l, j 13) Control ofmeasuring and test equipment.
he licensee shall establish measures to assure that tools, gauges, instruments, and other measuring and testing devices used in
%v activities ne saary limits.affecting/quahty are properly controlled, calibrated, and adjusted at specified ti l
h"1 (14) llandling, storage, and shipping control.
The licensee shall establish measures to control, in accordance with instructions, the handling, storage, shipping, cleaning, and preservation of materials and equipment to be used in packaging to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, and specific moisture content and temperature levels must be specified and provided. /
f }f (I5) Inspection, test, and operating status.
/ *
(i) The licensee shall establish measures to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status ofinspections and tests performed upon individual items of the packaging. Rese measures must provide for the identification of items that have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent bypassing of the inspections and tests. #
(ii) The licensee shall establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation. g (16) Nonconforming materials, parts, or components.
> ie licensee shall establish measures to control materials, parts, or components that do not conform to the licensee's requirements to prevent their inadvertent use or installation. These measurec must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items must be reviewed and accepted, rejected, repaired, or reworked in accordance with documented procedures.p,,/
h}f,jh (17) Corrective action.
- The licensee shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. In the case of a significant condition adverse to quahty, the measures must assure that the cause of the condition is determined and corrective action taken to preclude repetition. He identification of the significant condition adverse to quality, the cayse of the condition, and the corrective action taken must be documented and reported to appropriate levels of management. 4/
f ,f (I8) Quality assurance records. ~//, ///
j The licensee shall maintain sufficient written records to descrikd!(activities affecting quality. The records must include the instructions, procedures, and drawings required bft 75.105(ep prescribe quality assurance activities and must include closely related specifications such as required quahficatio Torpersonnel, procedures, and equipment. He records must include the instructions or procedures which establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. ne licensee shall retain these records for 3 years beyond the date when the licensee last engages in the activity for which the quality assurance program was developed. If any portion of the u procedures or instructions is superseded, the licensee shall retain the superseded material for 3 years after it is superseded.
)
(19) Audits.
The licensee shall carry out a comprehensive system of planned and periodic audits, to venfy compliance with all aspects of the quahty assurance program, and to determine the effectiveness of the program. He audits must be performed in accordance with wntten procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited.
Audited results must be documented and reviewed by management havi responsibihty in the area audited. Follow-up action, includmg reaudit of deficient areas, must be taken where indicated.
The formulae and tables in this appendix must be inserted.
(f) Appendis A-Determination of Al and A2 1 Values of A iand A for2 individual radionuclides, which are the bases for many activity limits elsewhere in these regulations are given m Table A-l. He curie (Ci) values specified are obtained by converting from the Terabecquerel (TBq) figure. The curie values are expressed to three significant figures to assure that the difference in the TBq and Ci quantities is one lenth of one percent or less. Where values of As or A 2are unlimited, it is for radiation control purposes only. For nuclear criticality safety, some materials are subject to controls placed on fissile material. /
f Page 15 of 17
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- e 4 m (175.105(f)(1)
II. For individual radionuclides whose identities are known, but which are not listed in Table A-1, the determination of the values of Ai and A2requires D nwnt approval, except that the values of As and A2 in Table A-2 may be used without obtaining Department approval.
111. In the calculations of As and A2for a radionuclide not in Table A-1, a single radioactive decay chain,in which radionuclides are present in their naturally occurring proportions, and in vhich no daughter nuclide has a half-life either longer than 10 days, or longer than that of the parent nuclide, shall be considered as a single radionuclide, and the activity to be taken into account, and the As or A 2value to be applied shall be those corresponding to the parent nuclide of that chain. In the case of radioactive decay chains in which any daughter nuclide has a half-life either longer than 10 days, or greater than that of the parent nuclide, the parent and those daughter nuclides shall be considered as mixtures of different nuclides. /
IV. For mixtures of radionuclides wMse identities and respective activities are known, the following conditions apply:
(a) For special form radioactive material, the maximum quantity transported in a Type A package:
B(i) /
, A,(i)
(b) For normal form radioactive material, the maximum quantity transported in a Type A package:
B(i) g j
, A2 (i)
Where B(t) is the activity of radionuclide / and A,(i) and2 A (l) are the i A and2 A values for radionuclide I, respectively./
Alternatively, an A ivalue for mixtures of special form material may be determined as follows:
A, for mixture =
f(i) /
, A,(i)
Whereffi) is the fraction of activity of nuclide iin the mixture and A,(i) is the appropriate Ai value for nuclide i.
l An A 2value for mixtures of normal form material may be determined as follows:
1 A, for mixture =
f(i) i
, A2 (i)
Whereffi) is the fraction of activity of nuclide iin the mixture and2 A (i)is the appropriate 2 A value for nuclide 4. !
V. When the identity of each radionuclide is known, but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest As or A 2value, as appropriate, for the radionuclides in each group may be used in applymg the formulas in 11V. Groups may be based on the total alpha activity and the total beta' gamma activity when these are known, using the lowest As or A values for the alpha emitters and beta / gamma Cqpg 4 b p.).rb.h WY&
Page 16 of 17 I
3 FAX INFORMATION U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS STATE PROGRAMS FAX: (301) 415-3502 NUMBER OF PAGES: 3 including this page DATE: February 9,1998 TO: Jean Miskin Bureau of Radiological Health New York City Department of Health FAX: 212-676-1548 information and Verification: 212-676-1556 Phone: 212-676-1556 FROM: Steve Salomon 301/415-2368 INTERNET: SNS@NRC. GOV MESSAGE: Attached are draft comments on proposed NYC j transporation regulations. If the omitted definitions are found elsewhere, please fax them '
to me. Also, any other comments are welcome. l Thanks, Steve.
i
l COMMENTS ON PROPOSED NEW YORK CITY REGULATIONS AGAINST COMPATIBILITY AND IIEALTH AND SAFETY CATEGORIES l
l State NRC Cateeory Reeulation Reculation Subiect and Comments B 175.02 and 71.4 Definitions 175.105(a)(5)
A number ofdefinitions are apparently omitted unless found elsewhere in the NYC regulations--
Carrier, Licensed material, Normal form radioactive material, Fissile material package, Type B package, Packaging, Type A quantity, and Type B quantity.
Because these definitions have significant transboudary implications they are category B, and should be j essentially identical to those of NRC. .
B 175.02 71.4 Low specific activity (LSA) material The exponents for the average specific activity in LSA-1 and LSA-III should be negative instead of positive. These are apparently typograpl ical errors but should be corrected because this definition is category B with significant transboundary implications.
B Ommitted 71.83 Assumptions as to unknown properties This provision was omitted. It was originally designated NRC in error.
Because this program element has significant transboundary implications it is category B and should be essentially identical to that of NRC. An appropriate place to insert this provision is after Section 175.105(d)(1).
D 175.105 (4) 71.0(d) Requirements for license Paragraph (ii) incorrectly cites NYC l secticn 175.105(a)(4). Although this program element is Category D, not required for compatibility purposes,
, .. 3 6s~~
the citation should be corrected to avoid confusion.
B 175.105(f) Appendix A Appendix A-Determination of Al to Part 71 and A2 The word " emitters"is omitted from paragraph V, apparently a typographical error.
Because this program element has significant transboundary implications,it is designated category B, and the program element should be essentially identical to NRC. Therefore, the word
" emitters" should be inserted.
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