ML20203J685
| ML20203J685 | |
| Person / Time | |
|---|---|
| Issue date: | 07/05/1995 |
| From: | Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Faircloth L SENATE, ENVIRONMENT & PUBLIC WORKS |
| Shared Package | |
| ML20203J328 | List:
|
| References | |
| FOIA-97-384 NUDOCS 9712220041 | |
| Download: ML20203J685 (3) | |
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.. UNITED STATES S NUCLEAR REGULATORY COMMIS810N 5 I waswinorow, o.c. asses 4ees
\,*****, July 5, 1995
% Honorable Lauch Faircloth, Chairman subcommittee on Clean Air, Wetlands, Private Property and Nuclear safety Committee on Environment and Public Works United states senate Washington, D. C. 20510
Dear Mr. Chairman:
Enclosed for your information is the Nuclear Regulatory Commission's Fiscal Year 1995 second quarter base table.
sir.eerely, ef Dennis K. Rathbun, Director office of Congressional Affairs
Enclosure:
As Stated cc: Senator Bob Graham l
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J#w 23, 1995 U.S. NUCLEAR REGULATORY COMMIS$10N FY 1995 $ECOND QUARTER BASE TABLE REPROGRAMMING ADJUSTMENTS (DollarsinThousands) eaprsersnelrg Adjusteente telsed Progreen Prior Seseline
- Second w ter Rwited Proposed Allocallen Program morose ' Altecation Program 301/95 menose '
8eactor Program $217.162 $265 $277.427 $t98 $21'.3!$
hwelear Materials and hwclear waste Program 91.336 !?! 91.607 328 31.935 Maeagew nt and twpport Program 175.826 312 176.138 3.303 179.441 Ir*spector General Program 5.080 0 5.080 0 5.080 total hRC $549.404 $848 $550.!$2 $4.529 $554.781
' the it 1995 initial and First euerter gese Table 82, dated march 8,1995.
These, changes are discussed on the following pages.
f this is the totet of hat's Ft 1995 sporopriations of 5525,581.000 and the use of $29,200,000 in funds unectigated at the ,
end of f f 1994 and carried over inti 't 1995.
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- l June 23,19M U.S. NUCLEAR REGULATORY COMMIS$10N FY 1995 SECOND QUARTER BASE TABLE .
REPROGRAMMING ADJUSTMENTS FOOTNOTE #2 REPROGRAMMING ADJUSTMENTS HG2ND OUARTER PROGRAM CHANGES (Reflected in 3/31/95 Baseline)
The program changes, shown in the table, have resulted from funding adjustments and the use of $848,000 in unobligated carryover funds. These changes are related primarily to increased activities in the following areas:
nuclear criticality analyses, simulator studies of nuclear power plants, digital interface guidelines for nuclear power plants, epidttiologic studies of radiation induced thyroid disease, consolidation costs, and mission related travel activities.
PROPOSED PROGRAM CHANGES (Reflected in Revised Allocation)
The proposed program changes discussed below reflect the allocation of
$4.529,000 of FY 1994 unobligated carryover funds to meet the programatic needs of the agency.
Reactor Program $898,000 The proposed program increase provides for technical assistance for c 9 rational data analysis, remote sensing support, and standard reactor design analysis.
Nuclear Materials and Nuclear Waste Program $328,000 The prcposed program increase includes funding for technical assistance for the analysis of operational data.
Management and Support Program $3,303.000 The proposed program increase supports funding for renovation related to normal wear and tear, space planning, and elevator maintenance for headquarter facilities, and the relocation of a regional office to the Atlanta Federal Center as required by.GSA.
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k" UNITED STATES ;
NUCLEAR REGULATORY COMMIS810N
- ! WASHINGTON, D.C. 3000HSM
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November 6, 1995 l
Jhe Honorable Lauch Faircloth, Chaiman Subcomittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Public Law 97-415, enacted on January 4,1983, amended Section 189 of the Atomic Energy Act of 1954 to authorize the Nuclear Regulatory Comission to issue and make immediately effective any amendment to an operating license upon a determination by the Comission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Comission of a request for a hearing.
In addition, the legislation requires the Comission to periodically (but not less fret,uently than oisce every 30 days) sublish notice of any amendments issued, or proposed to ve issued, under t1e new authority above.
Enclosed for your information is a copy of the Comission's Biweekly Notice of Applications and Amendments to Operating Licenses involving no significant hazards considerations, which was published in the Federal Reaister on Wednesday, October 2b, 1995 (60 FR 54714).
Sincerely, hh 'L William T. Russell, Director Office of Nuclear Reactor Regulation
Enclosure:
Federal Reaister Notice cc: Senator Bob Graham&ha - - cP g
$4714 Federal Register / V:1. 60, No. 206 / Wednesday, October T5,1995 / Notices publication of this notice will be is filed by the above dete. the considered in making any final Commission or an Atomic Safety and determination. Licensing Board, designated by the Normally, the commission will riot Commission or by the Chairman of the issue the amendment until the Atomic Safety and Licensing Board expiration of the 30 day notice period. Par,el. will rule on the request and/or However, should circumstances change petition: and the Secretary or the during the notice period such that designated Atomic Safety and Licensing failure to act in a timely way would Board willissue a notics of a hearing or SiweeUy Nottoo; Applicatione and result, for example,in derating or an appropriate order.
Amendments to Facility Operating shutdown of the facility.the As required by to CFR 2.714, a Lloonees ineotving No Slyntftcent Commission may lasue the license petition for luve to intervene shall set Hesards Cons &derations amendment before the expiration of the forth with particularity the interest of 30 day notice period, provided that its t.M petitioner in the proceeding and I. Background final determination is that the how that interest may be affected by the Pursuant to Public Law 97- 415, the amendment involves no significant tvsults of the proceeding.Ths petitaon U.S. Nuclear Regulatory Commission haurds consideration.The final abould specifically explain the reasons determination will consider all public wh) .utervention should be permitted Ithe Commission or NRC staff)is with particular reference to trie publishing this regular biweekly notice. and State comments received before Public Law 97-415 rev6eed section 189 action is taken. Should the Commission following' factors:(1)The nature of the of the Atomic Energy Act of 1954,as take this action,it will publish in the pe*itioner s right under the Act to be amended (the Act). to require tie Federal Register a notice of issuance made a party to the proceeding:(2) the i Commission to publish nouco of any and provide for opportunity for a nature and extent of the pettuoner's I amendments issued,or proposed to be huring after issuance. The Commission property, financial, or otner interest in I issued, under a new provision of section expects that the need to take this action the proceeding: and (3) the possible 189 of the Act.Thisprovision grants the will occur very infrequently, effect of any order which may to Commission the authority to lasue and Written comments may to submitted entered in the proceeding on the make immediately effective any by mail to the stulos Review and petitioner's interest. The petition should amendment to an operating license Directivn Branch, Division of Freedom also identify the specific aspect (s) of the upon a determination by the ofInformstlon and Publications subject matter of the proceeding as to Commission that such amendment Servicn. Office of Administradon, U.S. which petitioner wishes to intervene. l involves no significant hazards Nuctur Regulatory Commission. Any person who has filed a petition for 2 consideration, notwithstanding the Washington, DC 20555, and should cite luve to intervene or who has been i the publication date .nd page number of admitted as a party may amend the l pendency before the Commission of a this Federal Regleter notice. Written tition without requesting leavs of the 1uest for a hearing hoard up to 15 days prior to the first ) his biweekly noticefrom anyall includes person, comments may also be delivered to notices of amendments issued, or Room 6D22.Two White Flint North, prehearing conference scheduled in the proposed to be issued from September 11545 Rockville Pike, Rockville. proceeding, but such an amended 29,1995, through Octoter 13,1995. The Maryland from 7:30 a m. to 4:15 p.m. petition must sausfy the specificity lut biweekly notice was published on Federal workdays. Copies of written requirements descnbed above. October 11,1995 (60 FR 52927). comments received may be examined at Not later than 15 days prior to the first the NRC Public Document Room, the prehearing conference scheduled in the Notke of Consideration ofluuance of Gelman Building. 2120 L Street, NW., pmceeding, a petitioner shall file a Annendsnents '.o Facility Operating Washington, DC. The filing of requests supplement to the petition io intervene f r a hearing and peutions for leave to which must include a list of the a t on e don' intervene is discussed below, contentions which are sought to te and Opportunity for a Hearing Dy November 24,1995, the licensee litigated in the matter, Each contentinn The Commission has made a may file a request for a hearing with must consist of a specific statement of proposed determination that the respect to issuance of the amendment to the issue of law or fact to be raised or follov fryt amendment requests hvolve the subject facility operating licenu and controverted. in addiuon. the petiuoner no signincant hazards consideration. any person whose intmst may be shall provide a brief explanation of the Under the Commission's regulations in affected by this procwding and who bues of the contention and a concise 10 CFR 50.92, this means that operation wishes to participate as a party in the statement of the alleged facts or empert of the facility in accordance with the proceeding must file a wntten request opinion which support the contention proposed amendment would not (1) for a hearing and a petition for leave to and on which the petitioner intends to involve a significant incnase in the intervene. Requests for a heanng and a rely in proving the contention at the probability or consequences of an petition for leave te intervene shall to hearing. The petitioner must also accident previously evaluated; or (2) filed in accordance with the provide references to those specific crate the pouibility of a new or Commission's " Rules of Practice for sources and documents of which the different klnd of accident from any Domestic Licensing Proceedings"in 10 petitioner is aware and on which the accident previously evaluated; or (3) CFR part 2. Interested persons should petitioner intent!: to rely to establish involve a significant reduction in a consult a current copy of to CFR 2.714 those facts or espert opinion. Petitioner margin of ufsty.The basis for this which is evallable at the Commission's must provide sufficient information to , proposed determination for each Pubhc Docurnent Room, the Celman show that a genuine dispute exists with ! amendment equest is shown below. Building. 2120 L Staet, NW., the applicant on a material issue of law The Commission is seeking public Washington, DC and at the local pubhc or fact. Contentions shall te limited to comments on this proposed document room for the particular metters within the scope of the determination. Any comments received facility involved. If a request for e amendn ent under consideration. The within 30 days after the date of hearing or petiuon for leave to intervene contention must be one which,if l l .
Federal Registee / V:1. 60. No. 206 / Wednesday. October 25. 1995 / Notices 54725 proven, would entitle the petitioner to the petition and/or roguest should W consequena of en accident as evolueted and relief. A peutioner who falls to file such granted based upon a balancing of endorsed by the NRC in NUREG-t 366. a supplement which satisfies these factors specified in to CTR " Improvements to Technical Specifications requirements with respect to at least one 2.714(a)(1){i)-(v) and 2.714(d). Surveillaus Requirements." and Generic contention will not be permitted to For further details with respect to this tener 93-os. "1ine-liem Technical action, see the application for Specmcations improvements to Reduce participate Those permittedas a party, to intervene become amendment which is available for Surveillance Requirements for Testing parties to the proceedir g. eubject to any pubik inspection at the Commluion's Dunns Power Operations " Thm changes limitations in the order granting leave to Pubhc Document Room, the Gelman *m 8pP licable to PVNGS. intervene, and have the opportunity Io Building. 2120 L Street NW., The ADT entension from one hout to 24 participate fully in the conduct of the Washington, DC. and at the local public boun for a SfT that is inoperable due to
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hearing. including the opportunity to document room for the particular g e present evidana and cross examine facility involved. or pressure does not invcin a significant if a ngis uested, the Arisons Public Ser, rice Company, et al. locman in the conwquences of an accident. Docket Nos.STN Sa-520. STN S0-S29 In order to fully evoluste the affect of the SIT Commissloa wil snake a final ACT extension, probabilistic ufety enslysis determination on the issue of no and STN S0-530. Palo Verde Nuclear si nificant her.ards consideration.The Generating Station. Units Nos.1.2 and f rSAl methods wm utthud The results of 8 I
- fi al determination will serve to decide 3.Maricopa County, Arisona y"'"C when the hearing is held. Dole of amendments request: June 13* rnult, thm would be no signincant increm If the final determination is that the 1995, as supplemented by letter dated in the consequences of an ocddent amendment request involves no Aunust 16,1995. previously evolueted. Then analpes are signiflunt har.ards consideration the drscription of amendments request: dmiled in CE NPSD-994.Cornbustion Commlulon may issue the amendment The proposed amendmeats would Engineering Owners Group "loint and make it immediately effective, extend allowed outage times (AOTs) for Apphutions Report for Safety Inpoction Tank notwithstanding the requ6st for a a safety in}ection tank (SIT), a low. A07/STI Entennon." May 1995 hearing. Any hearing held would take preuure safety injection (LPSI) subtrain. 2. The proposed change don not crnte the place after issuance of the amendment. and an emergency diese! Jtenerator possibihty of a new or different Lind of
!! the final determination is that the (EDG) and add the bases for the occ6 dent from any accident previously amendment request involves a extended ADTs. evaluated.
signifiant hazards consideration, any Basis for proposed no significant This propowd chany does not change the hearing told would take place before hosords considerution efeferm/ notion; design. configuration. or method of operation the issuance of any amendment. As required by 10 CFR 50.91(a), the of the plant. Therefore, this c.hanne does not A request for a hearing or a petition licensee has provided its aristysis of the cmte the possibihty of a new or different for leave to intervene must to filed with issue of no significant hazards klad OI *CCid'"' In any previ usly the Secretary of the Commission, U.S. consideration, which is presented evalueted Nuclear Regulatory Cornmission. 3. The proposed chenp does not involve below.* Washington, DC 20555, Attention: e signment mducuon in a margin d safety. Docheting and Services Branch, or me 1. The propmd c.hany does not involve The proposed chenps do not involve a or to delivered to the Commission's Pubbca(" a signir I " *(C'cant "8 inemm
- in the,ignific.ni,,
pr duction in a margin of safety. tehtityY The proped chr , , do not affect the Document Room, the Gelman Building. $"0"d 2120 L Street, NW.. Washington DC, by the above date. Where petitions are filed The propowd arnendment does riot invoin (*,'$, a significant incnase in the probabiht or " d"'N'e'
- inis conuquences of an accident previousfy during the last 10 days of the nouca period. It is requested that the Utloner evoluted '""Q'[
g ,d b promptly so inform 'ho Comm sion bI The sefety in>ction Tuls istTil m Ch*n8e Thm eveintions demonstroied that the chenps are either risk neutral or risk a toll. free telephone call to Westem [sivelingcomponents System. TheinSITS the are Ernergency Cor beneficial. These evaluations are detailed in not'en acciden, Union at 1-(800) 244-5100 (in Minouri Initiator in any occident previously CE NPSD-994. 1-(600) 342-6700). The Westem Union ,y ius,ed. Therefore, tius chany does not operator should be given Detagram tavoin e significant incmw in the The NRC staff has reviewed the Identification Number N1023 and the probability of an accident previonly tir*nsee's analysis and, based on that following mesange addressed to (Project evolueted. review,it appears that the three Drwfor). petitioner's name and SITS wm desigrwd to mitigate the standards of 50 92(c) are satisfied. telephone number, date petition was consequences of 1mes of Conlant Accident' Therefore, the NRC staff proposes to melled, plant name, and publication WAl Tbm propowd changes do not determine that the amendments request date and page numtwr of this Ice deral [,,',',',",Y,('$"*Pd i s H$ die involve no significant her.ards Register notice. A copy of the petition consequences of accidents previously consideration. should also le acnt to the Office of the ,velueted do not significantly incime loco / Pubhc Document Room General Counsel, U.S. Nuclear The allowsd outan time ( AOTI extension location: Phoenix Public 1.ibrary 1221 Regulatory Commission Washington, for baron mncentretmn outside the N. Central Avenue. Phoenix, Arizona DC 20555, and to the attomey 'or the prescribed tunits does not involve a hcen s,,. signific at incneae in the mwqueces of an 85004-Nontimely filings of petitions for accident as evaluated and approvsid by the Afforneyfos licensce: Nancy C.14ftin, NRC in NURfXI-1432." Standard Technical Esq., Corporate Secretary and Counsel, leave supplermentalto intervene, amended petitions and/or petitions's request f* caum I r Combusuon Enginwnng Arizona Public Service Compan .P.O. Thw chenps m applicable to Box 53999, Mall Station 9068, P oenix, for a he'aring will not be entertained s absent a determinadon by the The changes pertaining to Sriinoperability Amona 850726 Commission, the presiding officer or the based solely on mstrumentation malfunction NRC Project arector: William H Atomic Safety and Licensing Board that do not invoin a signMcant increase in the Bateman. l l
54716 Tederal Register / V:1. 60, No. 200 / Wednesday October 25, 1995 / Notices ' i Carolina Power & Ught Coenpany, Ne new accident oc anarios are intreasuced Det het No. 5e-201, H. B. Robioeon bomforproposed no significant
*b*n the RIL* *!* ett**ded Ior a short 5 tease Electric Plant, Unit No. 2, period of tirne due to autornatic plant hazards considention determination: t Darlington Coussty, Soeth Carolina As required by 10 CFR $0.91(a) the '
"'P 08" M C n** fad" OPmtor adions licensee has tecauw the probability of a sLaultaneous Ibte of amendment request: issue of no s@provided September 11,1995. occurnace of an indepenoent accident is ificant hazards its analysis of th Iow. Thmfore, en allowance for Rlla to be consideration, which is presented Desertption of amendtnent request: j exceeded for a maximum of one 11I hour does below:
The proposed change is to (1) modify a not esoate the pouibility of a new or diffmnt limiting condition for operstion (LCO). Lind of accident frorn any accidest t. The proposed changes do not invoin a TS Section 3.10.1.3, to provide for P'evt usly evaluated signikant incream in the probebility or , temPor*ty conditions In which the full 1 The proposed change does not involve conwquencn of an accident previously l evaluated. yengt control rod insertion limits (RIta) a signiacant reduction in the margin of The snethodologie used in the occident are escoeded due to automatic plant safety. The proposed change adds an analyses recasin unch need. The proposed responses or cornervative operator allowente for PJLa to te exceeded for a changes do not change or alter the design inanimum of one It) hour. The proposed actions and (2) add an allowance for change don not invoin the addition or usumptions for the systems or components RILs to be exceeded for a time no greater modification of plant eqwpment. nor does used it to mitigate the consequences of an than the time criteria established by the alter the design or ooerotion of plant systems, accident. not advenely effectUse of ZlRID fuel fuel performance or cledding does asiel power distribution methodology or The overall performance of the IMctor impact nuclear design methodology. 1 hour, whichever is sooner. An action Control System. Power Distnbution Control. Tbmfore, omdent analysis enults m not is added for the reactor to tw placed in and Control Rod Drive System is not impeded the h9t shutdown condition within 6 degreded. Thes Is no increese in fatigue or The operating liroits will not be changed hours if compliance with the RILa nurnter of opconal cycles of equipment, and the analysis rnethods to demonstrate and thm is no change in system interfecu. operation within the liinits will remain in cannot be restored within the specified tirne period, Wher the R11a m evoeded for a limited accordance with NRC-approved tirne period, due to autornatic plant roethodoloipes. Other than the changes to the Bosts for proposed no significant responses or conserveuve operstor actions, fuel assembbes there am no physical horords corisidemtion determination: the margin of safety is not reduced tecauw changn to the plant associated with this As requirsed by 10 CFR 50.91(a), the the probability of a sirnultaneous occuinoce Technical S ecification chsnge. A safet licensee has provided its analysis of the of no independent accident is acceptably analysis wil continue to to performed or issue of no significant har.ards I w. Thenfore, en allowance for Rlla to be to d ns a compliance with conrideration, whir.h is presented C[c
'"'d'd I ' 'y"'* *"a"' ~*d =*avm " - b,ddiMM e Zlu I *"' I 8I h "' d "
seiow: This proposed change does not a:";a;*:l,l*
'3 e.d ,uei ,ods meei ihe .ame fusi essembiy involve a algnificant hazards and fuel rod design bases as other VANTAGE The NRC staff has reviewed the 5 fuel assembilu. In addition, the to CFR consideration for the following reasons, licensee's analysis and, based on this 50.46 cntena are applied to the ZlRLO clad
- 1. The propneed change does not involve review,it appears that the three fuel rods The un of thew fuel asumblin a significent incnew in the probability or standards of to CFR 50 92(c) are will not rnuit in a change *to the reload consequences of an accident previously satisfied. Therefore, the NRC staff design and safety analysis limits. Since the evaluated The proposed change don not proposeo to determine that the onginal dnign cnterta m met. the ZIRLO involve the addmon or modincat on of plant amendment request involves no clad fust rode will not be an initiator for any equipment nor does it alter the des 6sn. new accident. The clad material is similar in metenal or operation of plant systems. No significant hazards consideration.
chemical cornposition and has similar analyzed accidents are initiated by an entire l.ocol Public Document Roorn physical and mechanical properties as tontrol rod bank enceeding the Rita, due t locofion: Hor'sville AfemonolIJbmry, Zircaloy 4. Thus, the cladding integrity is automatic plant responsee or conservative H7 West Mly Avenue Hartsville malr. rained and the structurelintegrity of the operetot actions The overell perfurmance of South Carolino 29550- fuel ensembly fa sc* .ifected. 2.!RLO cladding the Reactor Control System. Power Afforneyfor licensee: R E. Jones, improves corrosion performance and Distnbution Control procutures and Control General Counsel. Ca'olina Power l' dimensional atabihty. No concerns have been Rod thve System is not degraded There is identified with respect to the use of an no incnese in fatigue or number of Light Company Post Office Bos 1551, aswmbly containing a combination of operational cycles of equipment. and thm is Raleigh, North Carolina 27602. Zircaloy-4 and ZlRLO clad fuel rods Since no change in system interfaces The NRC Project Director: David B. the dose predictions in the safety analyses consequences of previously evaluated Matthews. an not sensitive to the fuel rod claddmg acc6 dents are not increased since eaceeding matenal used. the radiological consecuences the Rits for a hmited penod is acceptable as Commonwealth Edison Cornpany, of accidents pntiously evaluated h the the probal.ihty of a simultaneous onurance Docket Nos. STN 50454 and STN 50- safety analysis remain valid. of an it. dependent accident is low. Therefore, 455 Byron Station, Unit Nos.1 and 2 Replacing the reference to the Final Safety sn allow ance for RILa to be escceded for a Ogle County, Illinois Analysis Report (FSAR) with a reference to maismurn of one itI hout does not affect the the l'pdated Final Safety Analysis Report probabihty of occurnnte or consequences of Dociet Nos. STN 50-456 ond STN 50-(UFSAR)is an editonal change to reflect the an analysed accident. 457. Braidwood Sfofion, Unit Nos. I and current document. Addmg that reload fuel 2 The proposed change does not crnte the 2. Will County, Illinois shall be similar in physical design to the possibihty of a new or different kind of Date of amendment request: initial core loading or previous cycle loading accident trom any accident prev 6ously September 14,1995. is a clarification. A reload analysis is n aluated The proposed change adds an cor.ipleted for each cycle in accordance with allowente for Rlls to be esceeded for a Descrsprion of amendment request: USNRC. approved methodologies. ma ximum of one (1) hour. The proposed The proposed amendment would allow Therefore, the proposed changes do not change dws not involve the addition or the use of an alternate zirconium based invoh e a signincant inenau in the modacation of plant equipment, not does it fuelcladdin8.ZIRLO and armit pmbebihty or consequences of an accident P aber the design or operation of plant systems limited substitution of ZlRLO filler rods previously eyaiusted. The only prm edural changes required wdi b, for fuel rods. The proposed amendment 2. The proposed changes do not enate the those associated with recovery from the possibdity of a new or different kind of infrequent condition of enreeding the Mlls also Nludes a clanfication and an accident frr m any accident prniously euitorial change. evaluated.
Federal Register / Vd. 60. No. 206 / Wednesday. October 25, 1995 / Notices 54717 VAN 1 ACE $ fuel penmbbee with ZIRLD f'a==amwealth Ediane Company. Process MSIV leakap.The analyon clad fuel rods setssfy the same design bues Declet Nat. 60-373 and 50.-374 Presented provide ensurance that this sa those used for other VANTAGE 6 fuel eddiuonal function does not compmmin the lASalle County Stat 6on. Units 1 and 2. whabahty of thou systems. They will aseemblies. All design and performance csiterie cos.unue to to met and no new LaSalle CousII' Illinois therefore continue to function u intended Dale of amendment requesf: August and not be subyct to an increened feilure rete teilure medanisma have been identined. The ZJRLD cladding material offen icoproved 28,1995, or e failure of a different Lind than ourmion rnistance end structural integrity. Description of omendment request: previously considered. will not be The pmpcsed changes do not aflect the The proposed amendments would in eddition, edurely im h*SIV functionali7the eseruuho design or operation of any oystem or support elimination of the Main Steam hmime MSm em not inawnd les component in the plant. The seiery functions isolation Valve L4eka8' Control S) stem being modified in any way and will continue of the related structures. systems or to provide their intended isolation function. (MSIV 1 S) and Instead use the main i coroponents are not changed in any spanner. The MSIV LES will be cut and capped, not is the rehebility of an structure, system. stearnline drains and condenser to l process MSIV leakage. The proposed which will coropletely isolete it imen other or cornponent reduced. The changes do not Pl ant systerns. Future degredetion of its effect the manner by which the facility is changes would also increase the alloweble MSTV leakage from 100 anociated piping would not impecs any operated and do not chany any facility other system or create e failure not design feature structure,or system. No new standard cubic feet r hour (scfh) for ce different type of equipment will to all four main steam nos to 100 scfh per @e"'h*jjk'* g lylAPg installed Since there is no change to the steans line (400 scfb for all four main maintained for the abandoned MSIV LES fecility or operating procedures, and the steam lines). safety functions and rebebility of structures. Basis for proposed no significonf pihing until it ischanges he proposed removed from do not thea plant. invoin systerns, or cornponents are not al'ected, the hazards considerofion defermination: significant reduction in a margin of se'ety proposed chanys do not caste ti,e As required by 10 CFR 50 91(a)' the because: licensee has provided its analysis of the The proposed chargte has teen evaluated et t any acci v ly with rapact to done tunits contained in evaluated lasue of no significant hazards Tb
'" P$*"
- 3. The proposed chanps de not involn a consideration, which is presented does Ic t enfy the u.
signifeent reduction in e er argin of enfety, beloW1 of the main steam lines and the condenser for The use of Zirceloy-4, ZlRLD, or stainless The proposed changes do not involve e leologe control,in place of the MSIV LES, steel f ller rods in fuel eseembhes will not signincant incnew in the probabihty or and with an ellowable totalleakage of 400 involve e e tgnificent reduction in the margin conwquences of en accident previously acfh. mainteine adequate rnargins to the of safety locauw onelyses using NRC- evaluated because: critene hateJ ehove. epproved methodology will be performed for The proposed changes involve eliminating Even though there is e reduction in the each connguration to demonstrate continued the tsquirement for the Main Steam loolation margin to ufety, the new doses remain well operetion withm the hmits that assure . Valve taakap Control System (MSIV LESI. within the critena of 10 CFR 100 and 10 CFR acceptable plant response to accidents and This system is manually initiated following 50. Appendis A. This reduction in margin is transients These analyses will be performed a design basis loss of Coolant Accident not significant when compared to the using NRC-approved roethods that have teen (LDCAl Smce operation of the LES is increewd milability and capability of the apprmed for opphcetion to the fuel initiated afler the occident has alrudy tegun, main stearn lines and condenser as e meth9d connguretion elimination of that system will not effect the of treating MSIV leakage. The new leakage Use of ZIRLD cladding material does not probabilary of a LOCA. The LES only pathway is consistent with the philosophy of char.ge the VANTAGE 5 reload design and interfaces with the main steamhnes, with the protection by multiple barmrs for limiting safety anelysis hmits. The use of thne fuel exception of one MSIV IES power supply fission product relope to the environment. In asumbhes will take into considerstion the which supphes power to the Reactor addition, the new method is passive and does normal core operating condicons allowed in Protection System Scram Discharp Volurra not rec,uire any new logic control or the Techniul Specificetions. For each cycle high lavel ectsm This power supply will interlocks. The new pathway is also capable reload core, the fuel assembhes will te remain in place aher the MSIV LCS 6s of handling a larpt amount ofleakage then evolunted using NRC-spproved reload design isolated from the main steamhnes Therefore, the MSIV LES. which ws previously subrect methods, including consideration of the core since the only significant systero interface is to concems that it would not funct6on at phys 6cs analysis puking factors and core with the main steamlines, and the eystem leakage rates higher than its design capacity. overop haear heet rete effects does not impe.ct the reliabihty of any plant or et reactor pressures greater then 35 psig equipment. elimination of that system will . revised calculated LOCA dows remem The NRC staff has reviewed the not cauw an increue in the hkotthood that well within the rendatory timits for MSfV licensee's analysis and, based on this any accident might occur. leakage retoe of 400 ocfh for all four main The pmt+eed change ta increase the steam lines (100 scfh per steam hnel, and the review,it appears that the three margin to ufety is not significantly redumd standards of 10 CFR 50 92(el ar, allowable MSIV lukage hmit imm 100 scfh satisfied Therefore, the NRC etaff through all four main steem hnes to 100 scfh as e result of the proposed changes. I proposes to determine that the Q",*d"$'Qd'd*CO, [juo The NRC staff has reviewed the licensee s analysis and, based on this toquested amendments involve no operabihty will not be degraded with the significant hazards consideration. local .[iow ,d gna n ,,di..g g . review,it appears that the three Pubhc Documenf Room location:For The consequences of a LDCA en not standards of to CFR 50.92(c) are Byron. the Byron Public Library District, significantly increased and do r.ot escoed the satisfied. Therefore, the NRC staff 109 N. Franklin, P.O. Box 434 Byron, previously scapied beensing criteria for this proposes to determine that the Illinois 61010; for Braidwood, the accident. General Electnc has calculated the requested amendments involve no Wilmington Public Library,201 S. revised LDCA doses, which have been added significant hazards consideration. to the pmvlous LOCA doses. These resulting locoIPublic Documenf Room Kankakee Street, Wilmington, Illinois vaNn am wou belcw the emptance cruena location Jacobs Memorial Library, 60481 of 10CFR100 and 10CF1t$0. Appendix A. ill;nois \, alley Community College, Afforneyfor heensee: Michael 1. The pmposed changes do not create the Oglesby,Ilh,nois 61348 Miller, Esquire; Sidley and Austin,One Possibihty of a new or different kind of Aftorneyfor heensee: MichaelI. F test National Plaza, Chicago, Illinois occident imm any accident previously evaluated because. Miller, Esquire; Sidley and Austin, One 60603' The proposed changes require the use of First Nations! Plata, Chicago. Illinois NRC Project Director: Robert A. Capra. the main steam pip ng and condenser to tio603.
54718 Federal Register / Vol. 60, No. 206 / Wedaesday, October 25, 1995 / Notices A71C Project Carector: Robert A. Capra. The proposed chanan are administrstive material propertm 95% lower bound burst Duke Power Company, Docket Noa. 50 in nature, and will not effect any operating curve. 95% lower bound oddy curnnt 369 and 50-370, McGuire fJutlear parameters or hmits *heh could result in a reduttion in a margin of safety. inessurement uncensinties. a id 95% upper Station. Units 1 and 2. Mecklenburg bound crack growth rate. The anal sis County, North Carolina The NR cenmustu t at tube Inkage en licensee. C staff s analysis and, has basedreviewed on this the CondiUonal Probability of burst are (ktte of ornendment request: review,it appears (nat the three acceptably low during either normal September 1,1995. operation or the most hmiting accident Descrsprion of amendment request: standards of to CFR 50 92(c) are condition. a postulated main stearn hoe bruk satisfied. Therefore the NRC staff (Mst.Bl event. Ceneric Letter 68-16 provided guidance proposes to determine that the As part of the implementation of the on reraoving cycle-specific parameters amendment request involves no k the which are calculated using NRC. significant hazards consideration- Qu g approved methodologies from the circumferential indications in the esponslon Technicil Specifications (TS). The loco 1Public Document Room location: Atkins IJbrary, Univershy of tranution region will be used to calculate the parameters are replaced in the TS with North Carolina, Charlotte (UNCC primary tr> secondary leakase. The allowable a reference to a named report which Inkage is bounded by the masimurn leakage contains the parameters, and a Station). North Carolina 28223. which results in doses within the opphcable Attorneyforlicensee.Mr. Albert Carr, dow litnits (t OCFR100 and General Design rt quirement that the parameters remain Duke Power Company,422 South l cnteria 19). The herit is calculated usina the wsthin the limits specified in the report. Church Street. Charlotte. North Carolina The proposed changes incorporate NRC. 28242. ,y
,'Q",*d',Pl "g'p"y,' C(*"('ysam gg ,
j approved methodologies, approved NRCProject Director: flerbert N. circumferential cru{k repair hm revisions to previously approved Berkow, proper 1 on of the postulated MSLB leakage i methodologies. or republished versions bued on the protected EOC distribution for of previously approved rnethodologies Entergy Operations Inc., Docket No, the nest cycle. The rejected EOC into section 6.9 2 of the Oconee TS. The 50-368, Arkansas Nuclear One, Unit $','$Ndy curr ' limits to which these methodologies are No. 2 Pope County, Arkansas fs sI on crack arc length. applied are (1) Am.al Power imbalance Dote of omcridmenf requesf j The reduction in the luk rate limit reduon Protective Pressure LirnitsLimits. prots.ctive and (2) Variable Reactor Low RCS Segmbe 25 I the possibihtv that a defer.t in a leaking tute P f endment regucst.- "'"8""' acceptable." ' ' 'h*' I' " ""I'Y Protective System Trip Setting Limits The pmposed amendinent adds a repair for the Flus /rlow/ Imbalance and Therefore. this change does not involve a limit for cirmmfemntial cracks in steam Variable Low Reactor Coolant S stem generator tubes. It deletes the signifir ont increase in the pnibabihty or Pressure Ttip Functions, and (3 power conme nen of any m.cident previously reauirement to re air cracks that are evaluated. imbalance 1.imits. Since the proposed within the repair imit. The proposed Cretenon 2-Dnes not create the Possibihty
.hanges only incorporate NRC. approved amendment also rcduces the PrimeII.to. of a New or Different Kind of A cident from '
methodologies into the TS the licensee see ndary leak rate limit. any Previously Evaluered. proposed that the changes are Basis forproposed no sign /ficant Implementation of the pro sed administrative in nature and can be hasards considero! ion determination: cirtumferentist crgk repair mit don not ar,sumed ta have no impact. or potential As required by 10 Cf R SC 91(a), the sntrodute any signifkant changes to the plant imhct. 01 the health and safety of the licensee has provideid its analysis of the design bails The only acident possible from implementation of this limit is a tute E" issue of no sigrtificant hat.ards Sous forproposed no sigmficant rupture, which has already been evaluated in consideration, which la presented the ANO-2 Safety Analysis Report. hasards consoderofion determination: below. The rnazimum primarv to-secondary As required by to CPli 50 91(a), the Cr tenon 1-Dues Not involve a Signifunt Inkage rate has been reduced to 1s0 gallone Ikensee has provided its analysis of the Increase in the Probabihty of Consequences per day through any one steam generator to issue of no signincant hazards of an Accident Previously Evaluated. help preclude the potential for escessive consideration, which is presented leakage dunng all plant conditione. The RG g g 0 * ,- (RCl 1.121."*. Basis for Plugging 1.121 DegradedC'* ' with crlierior, or estabhshing the draft Resul8 to The proposed changes will not create a PWR Steam Generatur Tubes 7 the traditional operstmns1 leak rate hmit considers (11 the detection of a crack before potantial tuba canificant hasards consid6 ration, as defined masimum depth based enteria for steam by to CRf S0 91, because: genersior tube repair impliculy ensures that rupture as a result of faulted plant tubes accepted for continued service will conditions;(2) the maintenance of a margin (11 The proposed changes will not trivolve to tube rupture of not less than three for retaht adequate structural and leslage a signifkant it; crease in the probabahty or normal operating conditions, and (3) that any integnty duttng noral operating, transient. consequences of an accident previously and postulated accident conditions. It is Inkage rate irsrnse will te gradual to es atuated The proposed changes are admhlstrative recognized that defects 6n tubes pematted to provide time for corrective action. The 150 m nature.and do not affect any system, remain in service occasionally gruw through. sgehon per day limit is intended to provide w all and deselop smaH leaks. Limits on or leakage detection and plant shutdown la procedurs, or manipulation of any equipment allowable pnmarv to-sesoodary leakage w hith could affect the probability or the event of an unespected crack propagation estabhshed in the technical spectikations resultmg in arcessive leakage, consequences of any accident. 5 team generator tube integnty is (2) The propo.ed changes will not create ensure tirr.ely plant shutdown before the structural and leakage integrity of the maintamed through inservice mspection and the possibihty of any new or different kmd pnmary.to-secondary loakage monitonng. effected tube is challenged. of accident trom any accident previously Any tutm's exceeding the circumferential et aluated. The proposed change to irnplement a circumferential crack repair hmit in the crack repair hmit are removed imrn service. The propmed cnanges are administrative Therefore, this charige dws not create the in nature, and cannot introduce any new espension transition region for ANO-2 inects possabahty of a new or different Lind of the criteria of RG 1121. The 40% degraded failure mode or transient which could cre_.aarea repair hmi' was determined by accident from any previously evaluated. ans accident, Cntenon 3-Dnes not involve a Significant 131 The propowd changes =ill not inveh e performing a structural analysis per the a signifkent reiluttion an a marlin of safety. ritoramendations of the HG and applying the Reduction in the Margin of Safety. InHowing uncertaintiet 45% tower bound The use of the circumFrential crack repair limit will maintain stearn generator tube 1 1
l Federal Register / Vol. 60, No. 206 / Wednesday. Octobel 25, 1995 / Notices M719 Wtegnty tornmenearete = tth the cnteria of below. The liceraee's analysis was The c.hanan a the onrtemperature and RG 1 !!1. tipo troplementetson of the hmal, presented separately for the following Ont;cwer ldeltal 7 reanor tnp functions do not invoin a toduction in the snarps of i even under worst use conditions, the areea: core thermal limits, wurnace of circurniers%s) crecung in the "'"Y I *'*""'h'"8 W "I#I""*"* 0""'mPM.uN ideltel T and
! with the Overtern;ersiure and Overpower pected t overpower ldeltel T reactor trip gd,ltel T rsector trip functions. as nrified by hd to te m 3 n re?or b pr e event the mults of the ucident analym, are during normal or faulted plent condtuons setpoint; steam generator process messurement accuracy; and DNB within ecceptable hralu. All transients i The thstnbut on of crec.k it.dicauons left in impacted by implettantauon of the R11)P wrvue will result in me,itable prirnary to, parameter surveillance requirements.
wmndary leakage and and6tional tute burst Core Thermal Limits. overtemperature ldelts) mthodol han tano amhsad and han i protability during all plant conditions. The instelisuon of stearn genretor tut
- T and onrpower ldeltal T Reactor Trip "[* ll[,P ybe n of fey I Setpoint regubgd for each aflected se ty anal sis is aluge end slwwes reduces RCS flow margin. (t) Opmtion of the facility in noordance metatained.This coulusion is not c[enged Implemenution of the circumferential oech with the propteed amendments would not the Overteropereture and Ove wer repear hmit willdecrnw the aumlerof tubes invoin a signi$ cant incnau in the b[eltal
[ T wtpotat modificeuona, o which snust be repelred by plunging adequacy of the reviwd Technical w probability or con vences of en accident sleevira thmby retaining eddauons Specitaations values to rnelateto the plant in prmously evoluet marpe that would otherwtes be reduce . The rev6eed Ovenemperature and e ante opereung condioon has been ihmfare, this change does not involv e Ovwpower ldeltal T toactor trip functions do aanfirined. Therefore, the changes to the significant reduction in the margin of u ty. not invoin en increene in the protability or Overtemperature and Overpower Ideltel T The NRC staff has reviewed the consequencn of an occident previously rnetor trip functsons do not invoin a licensee's analysis and, based on this enlusted tocause operation with then signincent reduct6on in the rnergin of eefety, nyiew,it appears that the thr,e revised nlues will not caun any dnign " Steam Generator Process Meesurement standards of 10 CFR 50.92(c) e, onelysis meptanu nuoria to te oc"'O Accurwy The structurel and functionalinusrity of all unsfled. Therefore, the NRC staff
"" d O um of h fullity in utordnu propcses to determine that the (lY"",",$"l,'d
, rpc r idelul T with the proposed amendments would not inmin e algnincant incmn in the amendment request involves no significant horards consideration. routor tnp functions are part of the accident protabihty or con uences of an ecc6 dent mitissuon responw and an not initiators for local Pubhe Discument floorn any transient. Therefore, the probability of P* A*"'I Y "'I"*"
locolson:Tomlinson Library, Arkansas The nd n pnoogl a sturn occurnace pmiously enluated are not g,n, w ,,, Tech University, Russellville, AR 72801. effated- opificant noemw in the prot ability or Afrorneyfor l'renser: Nicholas S. The c. banes to the Oortmoperature end consequenen of an utident previously Reynolds. Lsquire, Winston and Strewn. Onrpower Idettel T reactor inp funct6cas do ,y,3,,,,,d Operation with ihne revised 1400 L Street, N.W., Washington, DC rod uc' not tornersafl ct the integnty uuhred of the for inlugetin of nfiuionfsologscal niun will not couw env design or snelysis 20005-3502. scrvptomo crtierte to be eacceded The
'"C" **
- Suli CI S" "C'd'DL-
/=7tC Prefer! Dsrector: William D. d in "addition, C"""9"he t off site mass releases und as structurel and functioulintegrity of any g ,' nlant systern to unannted The Steam input to the dou calculetions are unchanged bntor Water tsnt trip functions are part Florida Power and Light Company, imm thow previously assumed umfore. of the ucident mitigetion twponse and ero Docket Nos. 50-250 and 50-251. Turkey th' on 'll' do'e Pmdictions remain within ,,ot themoeins taltutors for any transient.
Point Plant Unite 3 and 4. Dade County, the acreptants criterie of to CF R part 100 Therefore, the protability of cxturwoco limits for each of the translents aflected. previously evaluated is not affected N de Since it has been concluded that the transient I be changes to the reactor trip wtpoints do Duft of amendment request:May 5, analym rnults are unaffected by the not effect the Latogrity of the fission produci 1995, as supplemented September 28, parameter modshemnons,it is cxmcluded that t.fn,,, utilised for mitigation of rodiologu al 3993 the pm ibility or ccusequences of an done consequences as e result of en accident-Drscription of ornendment requett; eccident pmiously evaluated are not The Steam Generetor Water Level tow. tow The luensee pro iones to change Turkey L*C*"d. tnp setpoint usumed in the ulety analyses (2) The propowd licenu amadments od has t=wn rovtwd and screptable mults wm Point Units 3 an 4 Technical not crea'.* the possib6hty of a new or different obtained. The Steam Generator Water level-Spectgcations (TS) by revising TS 2.1.1, und of accident imm any accident low wtpoint is not credited in the safet> Selety Limit-Reactor Core; TS 2.2 pmiously evaluated. analysis consequently, the required marpn Limiting Salety System Settings- The mieed Onttemperature and of selety for each aflucted safety enelysis has Reactor Trip System Instrumentation Overpower ldeltal T reactor trip functions do been maintained to addauon.the of! site mass Setpoints.TS 3/4.2.5 Power Distnbution not cmte the pouibihty of a new or different ,,i,em used as input to the don Limits ~ Departure frorn Nucleate und of eccident trom any accident calculations are unchanged imm those Boiling (DNli) Parameters; TS 3/4.3.2 pm6ously evaluated locauw the utpolat pmiously essumed. Thmfore, the offsite Engineered Safety Features Actuation adlustments do not aflect accident instation dose predictions rema6a within the Systern Instrumentation and the wquencn No new o;wreting configurstle is ocxvptancs critene of 10 CFR Part 100 hmits int ediustments for each of the trsosient entlyses affected. auociated BASES, The proposed teing imruned by that would create e newthe setblure nenano In Smco it has twen determined that the mision 1o the TS includes (a) the addition. co new failure modes c.t brniting transient analysis results are urunected by implementation of Westinghouse's NRC smale fenurn han been identified. thou parameter modificeuons. FpL spproved Revised Thermal Design Therefore, the types of accidents defined in cxmcludes that the conseqaeaces of an Procedure (R11)P), and (b) e revision to the llFSAR ctentinue to reprnent the credible occident previously evaluated are not the Sturn Generetor Water levellow, spectrum of events to te analysed which incrwied. Law trip setpoint. determine safe plant operet on Thefore. 6t (1) The proposed license amendments do Basis for proposed no signifierint is concluded that no new or diffmot und of not crwte the possibthey of a new or di5mnt eccidents frorn thow previousi evaluated und of accident froen any scrident llotords constderation determination'. C" "** " As required by 10 CFR 50 91(a), the W *" I ""I"*
- revisions The wtpoint valun do not eHect the lK4nsee has provided its analysis of the D) The proposed inense amendments do numed accident initisuon sequences. In kuuo of no significAnt hatards not invoin a significant reduction in a addition, no new failure snodes or limiting consideration, which is presented margin of safety. single failurn han been identif;cd for any
$4720 Federal Resister / V:1. 60. No. 200 / Wednesday. October
- 25. 1995 / Notices plant equipment Therefore. the types of :
clanfication to more orxurstely reflect the suidents def ned le the UFSAR wnunue to survesilano actanty- inenase the time e Nuclear represent the credible spectrum of ennts to to 6nelysed =h6c h de' ermine safe plant The Allomable Value does not affect theInstrumentation System (NIS) channel operat6un. Therefore, the possibility of a view e:isumed acudent initiation sequences In in a functional group may be bypassed or dillerent kind of occident from any addition. no new fallure modes or single 1o perform testing frorn 2 to 4 hours. etendent evaluated is not incrnsed. falh.res han been identMed far any plant TS Toble J'J-2-Revise ACrlON (1)The prtipowd Inense amendments do equiprnent. Thmtore, the type of accidents Statement 14;incnase the time to be in not involve a sign hcant reduction in the dehned in tLO iTSAR continue to represent margin to wiety. the tredible sgectrum of vents to be flOT STANDBY with the numter of T he turnnt inhnical Spnification trip analysed whah determine safe plant OPERABLE channels one less that the setpoints and allowable values were chantled oper'euon. Theretore, it is concludedMinimum that no Channels OPERABLE to snannta6a the current ulety enelysis limits new or different Land of accidents frorn those requirement from 8 to 12 hours. Revise The Stum Generator Water level law low previously evaluated have been created as a ACTION Statements 14. 20 and 22 trip utpiint assumed in the safety analyses iesult of then revistons. increase the allowed outage time for test has teen te ised and acceptable rnults were ()) The propowd hcense amendmen s do of the logic trains ftom 2 hours to 8 obtenned The $ team Generator Water f.evel. riot involve e angnificant reduction in the low setpoint no nos c.redited in the ulety margin to safety. hours. Revise ACHON Statements 15. 18 and 25;increen the time ellowed for entlysis Conwguently, the required mergin The RCS loss of Flow actpoint assumed in of salsty .sr each affer.ted safety entlysis has the ulety saalysis remains unchanged 5tnc, a channel to be in teen maintained. Thereby, the edequacy of the safety enelysis limit setpoint value le service in an untripped condition from the reviwd Technnel $pecifiut6on values to unchanged and no ufety analysis is effected. 1 hout to 6 hours. malntale thi plant in a safe o the required margin of safety for each TS Table 4.3-1-Revise the tondmon as alsocortfarrood perating effect,d safety analysis is maintained. surveillance interval for items 2 s. 4. 7 DN3 parameter Surveillerne Requirements Thereby, the adequacy of the revised 8.10,11,12 and Note (9) from monthly (t)0 Technlcal Specification values to maintain to quarterly. Revise the surveillance w6th th;wrothon of the ferility in accordance e proposed ernendments would not '[ " " Tt fo en M Flow Allowsble Value oes not
' interval for item 2.b from monthly to startup, and item 3 from monthly /
p b61ty ta ue es of an occident involve e significant reduction in the margin startup to startup only. Revise the previously evaluated. ofufety. surveillance Interval for items 17.a. With the retenhon of the prev 6ous Safety 17.b.17.c and 17.d from monthl Analyses L.imits for Departure from Nuclute The NRC staff has reviewed the afwling. R t%hng (DNIllIT S. 3/a1 Si and the vaisting licensee's analysis and, based on this to "31 days,evisa Note (11 from 7 days" Reutor Coolant Systern IRCSilow flow trip review,it appears that the three ' and delete Note (8). Nomnnel Trt Setpoint (NTS). there to no TS Table d.J.J-Revise the incnese in ske protebdity or consequences standards of 50.92(c)are satisfled surveillance interval for items 1.d.1.e. of an suident prev 6ously evaluated teceuw Therefore, the NRC staff proposes'to 1.f,4.d. S.c,6.b. and 8.a from monthly there is no chany.e to any dn6sn or analysne involves determine that the amendment request muertence triteria The struuurel and no significant her.ards gfS BAS [SJ/4 J ! and. .J/4
~
JJ funcuonalintegrity of any plant system 6 consideration. unaffected. The propmed hcense Revise the BASES sntion for Technical IocalPubhc Document Room Specification Sections 3/4.3.1 and 3/ amendments reuw the surveillence locotson: Florida international 4.3.2 to reference the u ntinghouse requirements for DNB peremeters and University. Univers(ty Park. Miami, nnu WCAPs 10271 and 10271. Supplement irate the RTDP uncenaenty analysts 6nto 2. and asmciated Nuclear Regulatory e West 6nghouw methodology for the RCS Less of Flow determineuon ei the Florida 33199'LcenseerJ. R Newman Afforneyfor . Esquire, Moritan,Imwls & Bocklus.1800 MPons (SERs). Commission (f>RC) safety evaluation Allowable Value The thanges to the teet tot trip functwns M Street. NW.. Weshington. DC 20038. Basis forproposed no significan! do not effect the integrity of the fission N11C Pro Matthews. ject Director: Da vid D. hazards consideration determination: produc1 bartners utthsed for mitigation of As required by 10 CFR 50.91(a) the radiohinbral an accident. The enersindove toconsequences safety for the RCS as a result of Florida Power and 1.ight Company. licensee has provided its analysis of the tons of Flow trip remains prututed as the Docket Nos. 50-250 and 30-251. Turkey luus of no significant har.ards trip setpoints assumed in the safety analysu Point Plant UnPs 3 and 4, Dade County, below:consideration, which is prnented are not rev6wd, in addmon, the offsite mens Florida retows used as input to the do,e (1)Opersuon of the feelhty in accordance calcuktions are unchanged imm those Ibte of amendment request: July 26, 1995, as supplemented by letter dated with the propowd ernendments would not pres.ously assumed.1herefure, the offsite involve a significant increen in the dme predations femmin within the October 4.1995. probabihty or consequences of en accident eueptante er tone of to CFR Part too timtts Desenplion of amendment request: promusly evaluated for ee< h of the transients eficcted Since Theit licensee proposes to revise the De Pmpd chanan in Mnical ha teen determined that the tranuent resuhe technical specifications surveillance """'" *"'" * "" are unaffnted by these parameter intervals and allowed outage tinies for 4Howed outage Hmes for the subsect Reactor modifketmns. 61 a concluded that the the channel operational tests performed Protecuon System fRPSl/Nuclest consequentes of en ecodent previously on the analog " bistable"comparator instrumentation System (MS)/Enginwred evolueted are not turseawd Solety Futures Actuation System itSFAS) (210peration of the tac 6hty in accordance modules for the reactor trip. reactor trip tulog instrumentation have been r soth the proposed amendment would not permissivo functions, engineered safety scurdance with the secommendations a create the possibthty of a new or d fferent features actuation and permissive criteria of Weshnghoun WCAP-10271. klad of ecodent from any accident functions identified below. previousiv entuated. WCAP 10271. Supplement 2. and the NRC's 75 Toble J J-t-Revise ACTION SERA on the same subsect dated February 21. The resised Attowable Value docs not Ma ments Za. 6,12 and th incmase the 1985 and dated February 22.1980 create the posutnhty of a new or d6fferent kind of etodent fmm any accident ilme allowed for a channel to be The proposed changes do not insolve any Prev 60usly evaluated Rev'iuon of the in0Perable or out of service in an hardware or setpoint t hanges Similarly, the survedlance requuements merely provides untripped condition frorn 1 hout to 6 proposed chantes do not eher the manner 1r. hours Revise ACTION Statement 2b; wh6ch afety hinns. brnuing safety system wipnints or hmating condaions for opereHon
Federal Repeter / Vd. In0. No. 206 / Wednesday. October 25, 1995 / Notices 54721 em determined. implementation of the toetrumentet on is designed to ne twied in intervel imm monthly to quenerly, ht is, propeed denpo d<es eflect the petdebihty bypws and current Tschenel Specifications quanerly surwillance test intmals would ofleilum of the RP$. including NIS.and allow testing in bypass. Testing in bypass is not euced b alloweble instrument drift of LSFAS. but does not eher the menner in eleo scosmeed by !!1I $ter.derds. hw enalcq devices-w hkh protection is aflorded not the menner Therelm, testing in bypass has teen implemeneation of the proposed thenpes is in which hmnting wrpcinni critorie are prov6ously apprend and implementation of espaned to ruuh in en onroll impronment estabhshed for the RPS/I;$FAS the proposed changes for tesung in bypass in selety by: instrumentation sysums Conwquently,the dces not creet, the pcesibihty of a new or (e) Fewer inednnent reactor trips ger unit proposed chenpo do not rwult in en incnese different kind of accident from any per year. This is due to less frequent testing in the wverity or conesquenew of any previously enluawd. Furtherniore. since the which minirstaes the time spent in a partial etctdent previously enluated. pmpowd chanps do not alter the mann.t in trip condinon. Implementeuos of the proposed changes is whkh protect 6on is efforded cor the menuer (b) Higher quehty repelrs leading to espected to result la en acteptebly small in whkh bmiting criteria ero estabbshed fM improved equipment reliebihty due to longer
- lacanw in total RPS unevellebihty. This W RPS and ESF A5 isotrunentation eyewms, allowed repair tan w.
Inueese is primertly due to leu frequent the presibthty of a new or different kind of (c) Improvements in the effectinness of surveillantes and was poencelly quantihed accident from any previously onlusted has b opreting staff in monitoring and to te las then 3% within WCAP-10278. not teen created. controlling plant operet on.This is due to a WCAP-10271 eleo documents ht the The propowd changes do not twult in a less it,quent distrect6ons of the operster and heptementation of the proposed chenys is cheny he the menner in which the RPS of shift supervisoe imm ettending to also espected to twult in a signifkent E5FAS prov6 des plant protection. No cheny instrumentet6pn testing reducuon in h probabihty of core melt from is telna made w hich ehere the functlun of The Westinghouse snelysis demonstrates inadvertent teettor trips (WCAP-102711- N RPI or ESFAS (other then in a test mode) that any espected incroeses in probability of Thl2 le Ib result of e reduction in th* Rother, the likelihoud or probehihty of 0* com frelt or core damage frequency are emell numter of inodottent reactor trips (0.6 lewer RPS and ESFAS functionlng properly is the and am brefore weptable. Conooquently. Inadvertent toector trips per unit per yearl on), ,flect. h changes in Tec.hnical specifketions auct.rring during neung of the RPS Thefon.the proposed cbensee do not nuockwd with an extension of the instrutnentation. This reduction is primarily create the possibihty of a new tw different surwillance intervels and out of service attributable toles ng bypus for e phceble kind of accident nor invoin a reduction in times for the RPS/ESFAS instrumentation
'w"s"r'.02,'ibmenw"*e'L"AduO ' ar a daa'd 'a * '** ara ='-ni-maal'k atir e d c' th-C in tredverient core melt probab6hty is
^* ="" * ;M m' Bin of plant selety, c chen in Technical suffic6ently lary to counter the increened
$ h e macloud th an entension The NRC etaff hee reviewed the cxwe melt prohebility, resultlag in en owrall ofthe surwillence intervels and out of lirmneee's analysis and, bawd on this reduction in total core melt pmbebthty of servim tienes for the RPS/ESFAS review,it appears that the three instrumenteuon eyewme will not create the standards of 50.92(c) are satisfied.
di debilistic risk a new or different kind of ot7WCN- 0271. Supplement 21 possibth Therefore, the NRC staff proposes to aseen any pmvlously evolueted by wu documented by Watin house for the occident determine that the amendment requnt pner6c trnplementeuon of t$e pmposed the NRC, and dces not create the slbihty involves no significant hasards changes for IJ.FAS instrutnenteuon. This of a new or different kind of acci ont from g , enQc np]tus of sty" Wwtint houw enluation elong with the ordance loco / Public Document Room locoWn: Florida intemational R ontre o d n$a t it a6 core with h propreed amendments would not invoin e signi6 cent reduction in a margin of Unintsity, University Park. Miami, demap freque%rincnese Floride *.,3199. upper bound fu wunghouw represented plante. For an selety. Afforneyforlicenser J.R. Newman, oore reehstic testing stretep6es, the co,, The proposed changes in Technical domste frequency incrosse would be Spec 6hcotton eurwillence inwrwis and Esquise. Morgan. Lewis & Bocklus,1800 eviw's ntially less then this. allowed outeps tirnoe for the subloct RPS/ M Street NW, Washington, DC 20036. Ce miuently, h chance in Technical ESFAS analg instrumenteuon beve bee,t NRC Pmject Dsrector: David B. Spe< *ns sesociated with an utenston mvised in scardance with the Matthews' oftse 'illones intervels and out of mcomtrwndet6ons and criterte of een as a for b RPS/ESFAS Watinghouse WCAP-10271.WCAP 10271. Malme Yankee Atomic Power Corspany, instrumwieunn eystems will how only e Supplernent I, and the NRC's SEns on the Docket No. 30-309. Malee Yanhoe emell impct on plant risk. On this beste, f Pt. emme subject dated February 21.1945 and Ateenic Power Station. Llacoln County, uncludes ht the propamed thence will not dewd February 22,1949. g ,g,, how e signihcent effect on the probability or These changes in Teshnic41 Specifketions consequentes of Ikonsing be:Is ownte; and only effect b frequency of the channel Dole of amendment requesf: July 24, the pmhebihty or conesquences of en operellonel twis and b allowed outer 1995 occident previously evoluewd for Turkey times; they do not alter the menner in which Ducription of amendment request; Point does not significantiv incrosee. protection is efforded not the menner in The amendment would (21 Operation of the incility in occordance whkh limidng setpoint criterie am mod echnical Specification (TS) with the proposed anendments would not established. In addition, the fundamental pmceu to implement these channel 3,12.B by adding an Exception to pemnit creek the poesihihty of a new or diffmnt a once per operating cycle 10 day kind of ocddent imm any acx6 dent opereuonal tests mmelne the same. previously evaluewd. The proposed changes do not alter the restoration time for Remedial Action The propoemd changes in Tec*tnical snenner in which selety limits, limiting selety statement 3.12.B.2. The extended Specthention eurwillence inwrwis and system setpo6sts or limiting mnditions for restoration time would allow allowed outage tunes for the subject RPS/ operation em determined. The impact of maintenance to be cornpleted on the RSFAS analog tastnunentation beve been reduced teoung is to allow a longer tim emergency diesel generators. In revloed in accordance with the inwrval over which instrument uncertelnues addition, the Baals of TS 3.12 is recommendettons end utwrie of te , drift) may act. De siw specific revww suppIemented in support oI the Wwttn6 house WCAP.-10271 WCnP10271, of istorical dnft date and the conwrvatin Supplement I, end b NRC's SERs on the opphcetion of drtft in the Wwitnghouse ProPowd amendment. eenw subtect dated February 21,1985 and roethodology are pufhcient to demonstrate Sosisforproposed no significonf deted February !!, tees. that the basis of the Technical Specificat6on hosords consioerotion determination: Ttw pmposed changes do not invoin any setpoint determinetsons are not edwreely As required by to CFR 50.91(a), the bettiware cv wtpo6nt chanys. Some esisting effected by extending the surveillance licensee has providtd its analysis of the i l
i 54722 Federal Register / Vol. 60 No. 206 / Wednesday, October 25, 1995 / Noticea
^
luue of no significant basards consideretion. The NRC ataff has Maine Yankee Ateenic Power Conspany. The reduction in reted thennel power, Decket No. 30400. Malee Yaakse twetor protection systeen trip points, reviewed the licensee's analysts against the standards of to CTR 50.92(cl. The Atornic Maine Power Station. Lincole County, and operating limits conservatlvoly NRC stell's review is presented below: offset the reduction in reactor coolant Date of amendment request: August system flow. Plant operating conditions
- 1. The propowd arnendment does not 15,1995. remain bounded by Final Safety involve a significant inu&se in the Description of amendment request: Analysis Report (FSAR) Chapter 14, probability or consequences of an The proposed amendment would allow Safety Analysis. Thus, the proposed accident previously evaluate >d. reduced power operation as a function amendment does not crate the The emergency diesel pnerators of total reactor coolant flow, for flow Poulbilit a new or different kind of (CDGl are not accident initiators for any reductions as much as 5 percent below acclden any accident previously accident previously evaluated, nor does the cune ly spect d minl um flow. "j,yua Q he proposed amendment does not u p7o a used e e erm tc a +d w a il w n below n dch M a safety analysw. To evaluate the s>ffect of W.000 pm,if rated thermal oweris y,af f.
the proposed extended restoration ilme reduced y 1.5 percent for 1.0 pa;nt rated po'wer is conservatively of the EDCs fully, probabilistic safety percent that total reactor coolant flow la reduced, consistent with the ructor anal sts (PSA) methods were used. .. cool ,1t flow reduction. The power resufts of these analyses show no reduced' s/ rPg *" reduction is specifically designed to significant increase in tore damage , n n de n in, maintain the margin to the specified frequency. Thus, the proposed change acceptable fuel design limit on the A,us te9utred by to CIR 50.91(a)' the ' departure from nuclear boiling ratio does not involve a significant increase in the probability or consequences of an H P ji ed lys an 1ysis of the (DNBR), as defined in MY TS 2.2. The accident previously evaluated. consideration. The NRC raff ha, Ikensee has evaluated this margin using revi the lh's analysis spinst the methodologies identified in Maine
- 2. The proposed amendment does not the s Yattkee Tochtdcal Specification 3.14.
create the possibility of a new or , ,rttandards s review isofprwented to CFR below:50.92(c). The The reduction in power level, operating different LJnd of accident from any accident previously evaluated. 1, The proposed amendment does not lirr its, and tuctor protection system involve a significant incraw in the **tPointa ensurw that the DNBR rnargin The propowd chany does not alter probability or consequences of an is maintained for those FSAR Chapter
, the design, configuration, or method of accident previously evaluated. 14 events that rely on automatic reactor operation of the plant. Therefore, the The proposed amendment does not l'iP Protection. Power level reductions e ~
proposed change does not crute the involve any changw in the use that the total sensible heat in the poulbillt of a new or different kind of configuration of the reactor coolant reactor coolant system is conservative accident from any accident previously system. Thus, precursors to accidents for those events dependent on initial i evaluated, previously evaluated are unchanged. } stem energy. Thus, the propowd l 3. The proposed amendment dow not 5 en uction 1n or 8' '" ' Involve a significant reduction in a g, , , , , redu tlon in f ufe - l
**'8 I " d " I' minor chany to the overall plant heet Bawd on this review,it appears that The proposed chaop does not affect balance, which is conurvatively offset the thme standards of 10 CFR 50.92(c) by the proposed requirement to reduce are satisfied. Thmfere, the NRC staff system or component limiting conditions for operation, or the bases isted thermal power by 1.5 percent for Pr Poses to determ.no that this each 1.0 pertent reduction in reactor amendnwnt request involves no used in the deterministic analyses to establish the margin of safety.The PSA coolant system flow. Analysis by the licensee shows that a 1.0 rcent st(acant u haurdsDocumentconsideration.
Roorn evaluations used to evaluate the reduction in rated therms wer for location: Wlacasset Public Library, liigh pecpowdare changes chenpo eitner demonstrated that the every 1.0 percent reduction 7n reactor Street. P.O. Box 367 Wiscasset ME risk neutral or risk coolant system flow la sufficient to 04578. teneficial. Thus the p opowd cht.nge "" ^^" does not involve a significant reduction ensure that the current departure from Lynch " Esquire, Maine Yankee Atomic in a margin of safety- nuclear boiling retto is maintained. 'the licensee asserts that achieving the Itased on this review,it appears that reduced power arid other, related limits, runsw c M d4011 the three standards of to CFR 50 92(c) within 24. hours of a subject flow NRC Project Directo'. r Phillip F. are satisfled. Therefore, the NRC staff yeg,,, reductlon will not significantly increau proposes to determine that the the pmbebility or consequences of an amendment request involves no Northust Nuclear Energy Coespany, et accident previously evaluated. Thus, the al., Docket No. 50-334, Millatose significant hazards consideration. proposed amendment does not involve Nuclur Power Station Unit Noa,2 local Pubhc Document Room a significant increase in the probability New London, Comaectical locarsorn Wincasset Public Library, liigh or consequences of an accident Date of amendment reguest: Street. P.O. Box 367. Wiscasset ME previously evaluated. September 19,1995. t 04578. 2, The proposed amendment does not Description of amendment request: Attorneyforlicensee; Mary Ann create the possibility of a new or The topowd amendment would reduce Lynch, Esquire, Mame Yankee Atomic different kind of scrident from any the uency of the surveillance Power Company,329 Bath Road. accident previously evaluated. interva of the Safetyinjection Tanka Brunswick ME 04011. The proposed amendment does not Involve any modifications or additions (SITS) boron concentration from coce tWICPro/cet Director: Phillip F, oer 31 days to once per 6 month.s. to plant equipment. and the design and ~ Basis for proposed no sign? scant McNee operation of the plant are not affected. hosords consideration determination:
Federal Itegister / Vol. 60. Ns. 206 / Wednesday. October 25, 1995 / Notices 54723 As twqu[ red by 10 CFR 50 91(a), the Northeast Nuclear Energy Company, et a (plus or minust 3 pertent tolmnce for the licensee has provided its anal) sis of the al.. Ducket No. 50-336. Millstone Prusunwr ufety ulvn and the main steam issue of no signific. ant hazards Nuclear Power Station. Unit Nos. 2. ** W " * * *' M
- I'*L M 3 M *(
- consideration (SitC), which is presented New landon. Connecticut *",',',Y",I,P,,","Q* "g,d ,iA ' ' [g 'j','"
I*I " Date of omendment request- of design hus, even with the larger es-Pursuant to itGR50 92. Northust Nuclear September 29.1995 found tolerances. the rnargin of -
- for Drscripfion of omendment request; RCS and steem generator onrp i *ation Energy Company (NNICol has reviewed the as maintained.
profosed charige. NNTCO tondudes that the The proposed amendment would D change does not involve a signinunt haards modify the Technical Specifications 3.4.2.1,34.2.2.3.7.1.1, and Table 4.7-y,,', '$8["['"[,* "Qh",,$"
, , p consideration sina the proposed c.hany minusf 3 percent u.lound tolersace and to setiones the critens in loCTR$o 92k).1 hat 1- extend the margin for operator action to one is, the proposed thenge does not- The proposed license amendment hour. A compenson of the calculated doses 1 Involve a alpifiunt incnase in '.he combines three separate changes to the shows that with the new essurnptions, there pro'ebility or consequences of an accident Millstone Unit No. 2 Technical would te a very emell incnose in calculated previously analysed Specifications which pertain to safety doses. The increased calculated doses.
. The revtud Safety injection Tank ($fT) valves. The first proposed modificatir'n however. remain well telow the Standard surveillance requirements meet all design would expand the as found tolerance of II " "CC' *"C# Cdd' end performente critene The thenp has no """gm" e Posed [ange in the sh' utdo mode oes not tropact the probability or lelffect on the ability of the SIT to erform the lift settinE[ressure for theconsequenen of en accident previously pressurizer an the main steam safety its duigned function of providing ted valves from the current value of plus or eniusted. The proposed chasse makes the
= eier to tie core following a oction required for inopereble main steam minus 1 percent to plus or minus 3 depressurination es a result of a loss of safety valves consistent with the mndes that pertent. Clarifications have also toen Centent Accident (LDCA). Therefore.the PmPo$ed by specifying that the lift the technicpaincauon is apphcable thenps to SfT surveillance requirements setting pressure shall te determined at would not ify the assumptions made inand will not incrww the probablhty or '$ '1" d reti g conditions and all '"g*
a n,*r uences of an accident previously ee a P d c &o v.ive orinc, sir. from technic.i dm W
- 2. Create the possibility of a new or the raluired lift setting. The second specinuuons hu an irapact on any design different kind of eccident imrn any Portion of the modification would tesis accident anelysia.
prniously enslysed. eliminate the need to verify the main Based upon these evolustions,it is 1he revised SIT surwillance requirments steam ssfety valve orifice size. The third concluded that the proposed changes do not meet all duign and performance criteria The modification would modify the main significantly loosene the probabihty or change has no telftect on the ability of the steam safety valve action statement to consequences of any design tesis accident. SrT to perform its design function of reflect that if a mein steam safety valve 2. Cnate the possibil6ty of a new or diffmnt kind of occident from any providing torsted water to the core following is inoperable and compensating action sed e depressurisation as e anuit of a LIXA The cannot be taken that the plant must tw Previously a chane to the SfT surveillena requirement will not cnete the poulbthey of a new of brought to hot shutdown (Mode 4)in 12 D'fl ib i ren
@dentbf a o w orany previously analyzed.
d of hours instead of cold shutdown (Mode diffent Lind of accident imra any 5)in 30 hours. The proposed chanan do not cheap the previously analysed Basis for proposed no significant es.left wtpoints The change in p found
- 3. Involve e significant reducuon in the horords considerution deterrnination: toi, %ces for the wlety velves is being made
'""4'" *I '* I'D' As required by 10 CFR 50.91(a), the tt Ject the results of past surulliances that The toren concentation of the MT will not licensee has provided its analysis of the inoicate that the setpoints can drift mon to eflected by the chany to the survwillance than the curnot citeria. Howent, thm is no luus of no significant hasards ST wiic at t o r id on consideration ($11Cl, which is presented $agnin the plant mangumuon or in udef basis constatent with the historial I*I* The proposed change which requires the performen a Thm chanps will ben no * *
- The propowd changes do not invoin plant to go to Mode 4 in 12 hours testead of krnpact on the mergin of safety. an SHC because the changes would not: Mode 5 in 30 bours if the action statement
- 1. Invoin a signincant inceses in the is not met, is consistent with the appbcable The NRC staff has reviewed the probabihty or consequenas of an occident modes of the technical specification il e., the tiemins,ee's analyste and, bened on this previously evaluated. technical specification is not opplicable in review,it appears that the three The change in the as found pressuriser Mode 41. No new or different kind of standards of 10 CFR 50.92(c) ar, safety vain tolerance will not incnue the occident from those previously onelysed can satisfied. Therefore, the NRC staff Pmbebihty of ocrurrence of any of the design to postulated as a result of this propond tesis accidents. Enn with the tanter c.bange proposes to determine that the t lorsnm.the setpoint will provide margin to Thus. the changes do not enete the amendment request involves no normal opersuon. the reactor setpoint. end a pificant hasards consideration. FORY Ipower operated relief valve setpointi- occident pouibihtbof any a new or different previously kind of analysed.
local Public Docume tf floom This minimates the challenges to safety 3 Involve a significant reduction in the location: L4arning Resources Center, valves and assuns that thm is no incnase roargin of afety. in the probabinty of an inedvertent opening As discussed above the loss ofload event Three Rivers Community Technical College. $74 New London Turnpike-
*I ' P'""""' 'IIF d'h'8"*3'""I '"" *I *' **I" Norwich, CT 06360- with the increase "Y in all"I"'wed8"."foun es d ' '"" steam is lation vain han been teen lynd to tolerance for the mein stearn oefety valves, show that esen with a iplus or minual 3 Afforneyfor licensee: Lillian M. the setpoints will still provide margin to percent iolerance for the pressuriser safety Cuoco. Esq., Senior Nuclear Counsel, normal operation. Thus, thm is no impact ulm and tne main steam ufety nivu.that Northeast Utilities Service Company, the pmtsbihty of an inadvertent opening both the peak RCS pressure and the pesh P.O. Box 270,llattford, CT 06141-0270 of a steam senerit r safety volve. steam generator pressure rernein below 110 The loss of load event and the tradorient pertent of design Thus, even *vith the larger NRC Profect Director: Phillip F. cknure of one main steam isolation vain es.found tolerances. the margin of safety for McKee, han been reanalysed to show that even with KCS and steam generator onrpressuritation
*54724 Federal Register / Vd. 60. No. 206 / Wedneaday, October 25, 1995 / Noticos ls maintained la addition, the steam
- 1. Involve e significant lacrease in the =
tenerator tube rupture hu toen reenalysed with a Iplus or reanuel 3 percent tolerance on probability or consequences of an occ2 dent Requiren. uts or changes thereto are the stearn generator safety valves and h previously esaluated. provided to the Susquehanna Reyww p results show en insignifuant increue in the The proposed change relocates the Commmn for information. Thus. thm are calculated doses provipons of the Fue Pmtection Pmgrom ht no advern impacts on the protectin The proposed change slao directs the are contained in the inhn6 cal Spectfications boundann, wirty limits. or margin of safety. and placn them in the Technical siru.e operabihty and survetilance operstar to bring the plant to hot shutdown Requirements Manual. No requirements are requiremsats wul remain la e controlled ' instead of cold shutdown to be consistent
> with the oppikable modes of the tubn6 cal teing edded or deleted Review and approval document. the changes do not reduce specincation There is no tropect on the of those portions of the Fire Prutoction effectiver.eos of TechnicalSpecification Prugram contained in the Technical requirements Any c.hanps to the Fue anurnptions made or the results of any t' accident previously analysed. Requirements Manual and revisions thereto Protection Program requirements will be
- will to the responsibility of the Plant rnade in accordance with the provisions of 10 Thervlore. It is concluded that do not trivolve a sigmficant reduction in the the chanres Operations Review Conuninee O'R $0.59 end condition.
justtheas fireitprotection was license their mpunsibility to review chan i margin of safety. to the fim protection LLmlung Condition The N The NRC staff has reviewed the O wration and Survellance R licensee's anal)' sis and, based on this bnsee'RC staff het reviewed s analysis and, band on this the when they were part of the Tehuiremente nical review,it appears that the three review,it appears that the thrw Spnifkat6ons. Requiring review by the Plant standards of 10 CFR 50.92(c operations Review Committee retalortes the stendards of 10 CFR $0.92(c) are importance of the Technical Requirements satisfled. %crefore, the NRC staff satisfled. Therefore, the NRC staff proposes to determine that the proposes to determine that the Manual and h recuirements controlled by amendment request involves no amendment request involns no Approwd Technical Reg romenta orit and significant usurn hazards a multidiseghnwi consideration. r significant hazards consideration. local Public Document Room (" ,$,"*,% h,e Loco / Pubhc Document Room location:Osterhout Fros Ubre , locritiori; terning Rnources Center, information. No desl 3 n buis asidents areReference Department. 7i Sou Three PJvers Community Techalcal strected by h change, nor am ufety systerns Franuln St:eet. %lbs. Barn. College,574 New tendon Turnpike. advernly affected by b chanp. Thefore, Pennsylvania !8701. Norwich, Cr 06360. the is no impact on & probability of macurrence toccurrencsi or the Attorneyfor ficensee:)sy Silbe'g, Attorneyforlicensee: Ullian M. Esquire, Shaw Pittman. Potts and momquences of any dnign basis scendents Cuoco. E ., Senior Nuclear Counsel. 2. Create the pouibiury of a new or Trowbridge. 2300 N Street NW., Northeast tilities Service Company, d ' I3"d dent imm any Waahington. DC 20037. p"'[j,, y NRCProject Dsrector: John F. Stotr P.u. Box 270. Hartford. CT 06141-0270. NRC Project Director:Phillip F. Tbe pmposed chan'po relocate & McKee Virglaia Electric and Power Company. provisions of the Fire Pmtection Pmpram that Docket No. 50-338. North Ann are contained in the Technical Specarications Pennsyleania Powe? and Ught and places them in the Techancel Station. Unit No.1. Louise County. Company. Docket Nos. 50-387 and 50- '"' Virginia 3na sua ddei d eye " Station.quhaana Steam Electric TWT c[ntc i Requirements Manual. T(m are no new September Date of amendment request: Unita 1 and 2. I,userne County. 19,1995. Pennsyleania Esilure modes assuciated wtth the propowd chanys Thmfare, since h plant will wscription of amendment request: Date of omendment request: mounua to operete as destgoed. the he proposed change would revise the September 18,1995 Technical Specifications (TS) for the pmposed chanses wul not modify b plant Description of ornendment request: rwponw to an accident. North Anna Power Stadon, Units 1 & 2 The proposad amendment would 3 Involve e signifkant reduction in a (NA-1 & 2
' relocate Fire Protection requirements marino of u sety. changes wo). Specifically, the proposed uld revise TS Umsting from the Technical Specifications to the No thany la being pmposed for the Fire Condition for Operetion (LCO) 3.7.1.1 Pmtection Pmgram quiremenu themselves. d Action Statements. TS i sble 3.
d t
'th Ito would tevise 7ocho m ndrn n a na e and e ne N@ur Mtled Meximum Allowable Ray WuWn Mux @
leal Specifications to incl.ade the requirement for a contained therein are betog incorporeted into S*tpoint With Inoperable Steam Une b Tdo kel Requinments Manual. Plant Safet program and procedure to implement procedu n will conunue to provide the Operation" the Technical Requirements Program, ipecifk untructions neceenary for the andMaximum "y Valves Allowable During 3 Imohowe and also revises Technical implementation of the requirementsdust as Neutron Flux High Setpoint With Specifications to add the requirement wtaa > requiremenu runded in the Inoperable Steam Une Safety Valves for the Plant Operations Review Technical Specifications. Fire Protection During 2 I,oop Operation. and the Committee io review all proposed Prosmrn chanpa will be submet to the 33,,, 3f 4,7,3,3, . 3,g,,y y,"ly,,agg, go,TS pnwistons of to m 50.59 and the current changes Io the TechnicaI Requirements 1 & 2. Table 3.7-1 Provides the Prognm and to forward copies of r re peutect6on 16cenu condition. As such, h maximum allowable power tante protecuve reviewed changes to the Susquehanna changee (to not directly affect boundenes por does it (do theyl anfmpact neutron & flux high setpoints with one or Review Committee- safety limits for the boundary Review and more main steam safety valves (MSSVs) Bosssforproposed no signif approval of those portsons of the Fim inoperable dunng two loop and three hosords conssdemtion deterrn.qcont notion: pmtection Pmgram contained in the loop operation. The proposed changes As required by 10 CFR 50 St(a),the Technkel Requirernents Manual and the provide more conservauve power ta licensee has provided its anal) sis of the avisions thmto will to the twponsibility of neutron flus high setpoints calculat issue of no sinnificant hazards the plant operations Review comrruttee just utilizing the Westinghouse Electric as it was their res consideration, w hlch is Presented (h*"B" *h' h*ponsibility to review CoFPOT8 tion (Westin house) bd* *, PN*CU*" Id*3 d"8 ******"*** condition for Opereuon and Surveillance ' EI "" d' ' The proposed chenp*, do not: Requirements when they were part of the the information for setpoints for two Ter.bnical Spec fication. Approved Technical loop operation. The proposed changes also revise the TS Bases to reflect the i l l l
. . - - - . _ . . _- - _ - -~. - . . - - _ - - -
federal Register l Vrt. 00 No. 200 / Wednesday. October 25. 1995 / Notices r4725 methodology used 1o establish the new kind of accioent from any accident setpoints, and delete the 140 Action Specibily, operstmn of the North Anna imiousiv enluated power statlan in utordance with the
$6stement and the TS Bases for Iwo loop A inmin e significant nduction in a pro =
operaWn margin of asfety. wiljosed not Techn6al spufications chtnses Addstionally, the information in Table The proposed thenge reduces the total 1. Insolve e significant incnne in the t 3.7-1 and the 140 Action Statement energy ensure hof abihtytia reactor of the MScoolanNi stern thei will prohebihty or conwquences of an notadent essociated with two loop operation have theit intended function as assumed in b to periorm previouly miumd. been deleted since Virginia Electric and tvrrent occibas analyws Conecting this No new or unique accident precursors are non totmduced by thwe chanew to ournillance Power Comp 6ny is Prohibited by the us,,tonomatista restores the margin of requirements Tiw probebtitty of turbine license from operating in this y i, wh,i ,,, onginally envissor ed la configuration. addition, the swul's or b occident analyses ruiuite erectAon with an extended 1S-month test interval for b nheat stop snd intmept Sosis forproposed?o significonf whhch are documented in the UFSAR tound operation under the proposed charips. no volves has toen determined to to within the horords consideration detmn/ notion: appuceble acceptance crtteria, ht the is no wiety meepin ieduct on l As re ropwed charg does not The hoevy hub dwign of the turbine rottes
- bcen' quired by 10 CFR 50.911a), the Tbmiore inalw a signsthe pscant mducten ta provide e margia furtherof apurance that the l .ne has Provided its analysis of the pmtebility of eurecten of dwtmoin Assue of no significant haurds talety.
missiles ternains minimal. contadention, which is presented The N Sawd upon the twults of the probabilistic i beluw: licenwe,RC staff has rey;ewed a analysis and, bened on this the eveintion,the embebaht of a turbine 5 incall retion of the North Anna r" View. It 8PPears that the three pnoted mmile u im than 10 e per ym. pow Statio accordence with the standards of 50 92(c) are satisfied. which h Commlwien hw endorsed as b emptaus level for turbine operation. p"g(gsed Tubatul Specifications changes Therefore, tha NRC staff proposes to The rebut stop and intmept valve determine that the amendmtnt request inspection laterval utenston and b
- 1. Involv, e signif cant lacreees in the involve. no significant haurds consideration. ehminotion of h addiuonal viewt/ surface prutobihty prev 6ously entwor conNueous of an eccident inspect om do not che h d wign, This che%p redures ne power level 61 loco / Public Document Room operatio2. or feilure ta es of the nlm and whkl. %e toector may to operated a 4th oM locolion:The Alderman Library.Special der camponuts la h tuetu mnpwd or more mate seem ufety utves (MSSVal Collections Department. University of snopereble to ensure he the esconder Virginia. Charlottesville, Virginia TS$o",fischanses dc notinvolve e 22903-2498. ens nincant incmue in the probabihty or eystem is not overprmunsed durlus t e nwet sevm prmurtsetion trans6nt of the Atrotneyforlicenser: Michael W. comuences of an accident previously eye Sted.
secondary side There es no change to toe Maupin. Esq.. Riverfront Plan. East funct6on of the MSSys by the propowd Tb . demonstnted high rebbility of b Tcwer 951 L Byrd Street. Richmond
- sa a u t r suh ,"' wd turbiu roheet stop and intmept velves and the verincattoo rik operabthty of the other C ProjectIhrector: Devid B.
prayoned thenges will provide coneerntive power reny neutmn flu high trip wtpoints ows. ']Q3j g ($$gd* such that the maximum power level allowed Virgiana Electric anel Power Com protection systern will operete es designed. if y, needed. Turbtw rehnt stop sad intmspt br opeterion with inopmble MS$t:is Docket Nes. 84-33s and 36-339 **1" '"t18 rform'd to d** ha MS V Anna Power 54auen. Unita No i and d*'******8dtP*h' t'h*bthey of these velves. is c will I i mot increase h probebthey of an accident. Th6e chany is consaient with h curwnt No. 2. Laesias Coasty, Virgiale Og;te of amendment request; [ and powwner wlm) willconunue to to 3, 3m acc6 dent enelyels assumptions br the MSSVs Se tunber 19.19M. and does not chany h containment verined every 31 deye or as required by h scription of omendment roguest: Technical Spec 1hcauons. twpones for en dwign basis neat The proposed change would revise the 2. Cmte h poselbility of a new or Therefuro, no c any to the mittgetL.o of en Technical 5pecifications (TS) for the diffmot kind of accident from any eccident occident will rwuh imm this propW North Anna Power Station. Units No.1 Previousilyl evolueted thenp and no thange will occur in % and No. 2 (NA-162). Specifically the consequenm of any acddent curnatly proposed chane would increase the cheny to the surnillance requimments will analysed.
- 2. Creete the possibility of a new c' surveillance test interval for the turbine not requin hardwm modifketicas 11 e..
diffwent kind of ecrident trum any modent rehool etop and Intwtspt valves to once alterotions to plant configurouon). operation prov6ov=ll)I evolueted, por 18 months and extend the visual of the lecthues with thm propowd and surface inspection Intwval to 60 Tochancal Specifkathou dou not cmte the Since h implementation of the propowd posibiltry far any new or dt9 mot had of changes to the wtpoints will not require months. The[toposed change wouldaccident which ha act alrudy toen hard ware modifkatkms (i e., alterations i also remove e requirement to perfotin ovelveted in the Updated Final Selety plant conf puretion).operouon of the additional visual and surface Analyels Report (UFS ARI. la addition. k teethtbes wtth thm popowd Technkel inspections on the remaining turbine ,,sults of h probabihstic mlption SpectGcolions does not caete the possibility overspeed protection system control lodiceve ht no additional transients hm lur any now or dithreat kind of utident boon turodued whlch has not etterly toen evaluated. valves of that type when unacceptable flaws or excessive corrosion are The proposed revision to the Technical The proposed revision to the Technical Specthcotions will not rwult in any physical identified which can be directly ahmt6on to my plant eyotan.not would
$secifications will not resulttoto aftmtion to any plant rystem. not would any physkal attributed to a service condition specific :hore b the inspected velve.
there be e change to the method by which any ul e.y releaed eyotem pwform its any selety related system performs its Basisforprope;ed no signifkoni funcuon. The delen and operation of h function The dwign and operstkm of the llosords considerotion cleferminadon: turbin' o*ePed protocuon end turbine main steam eyotem is not being chenyd As requtred by to CFR SO,91(a). the ""*'"I 'Y""' "'e not teing chened Tbm changes do not thenp b dulen, bconm has provided its analysis of the The proposed Tschalcal Specinceuons , operation, or hilm enodes of b male steem issue of no significant hazards thenps do not e8ect the daign, opwouon, syment Thenfore, the propoeed thenge does consideration. which it prwented or failure mode of the ulm and other not create the possibihty of a new or difleront below: cx.mponents of h turbine overopwd protection systern.
.- ~ .
i . 54724 Federal Regioler / Vol. f 0, No. 206 / Wednesday, October 25, 1995 / Notices l Therefore. the propned chanae dcas not trtste trw posit,ility of a new or different Description of amendment request! Information such n equi inent cide any auident This appliration to rvvise the ( [o o g operability r9irements uring Bra duood. Unit 1. Techniul 3 lavolve a signdaunt reduction in a Spgitatiorss (TSsl p oposes to shutdown conditions.12) clarifying margin of safety. requirements such as limiting f (ontinue to use the v tage based repair conditions for operation aid action b W proposeil c her.ges would noi redute the margin of salety as defined in the basis criteria which were added to the
; statements utilizing STS terminology,
' lot any luhnu_al Speofnet.ons. The design Draldwood. Unit 1. TSs by a ikent,e 01 deleting superseded requirements and operation t,f the turt rw overspeed ornendment issued on August 18.1994.
This August 15.1995. request will be and modifications to the TS based on t ge nsed a the licersee's responses to Generic e bI oIthe c nsidered by the staff only in the event tatters (CL), and (4) relocating spec
' turbine reheel stop and intercept telves w6ll that the staff un not reach a timely tie demonstrated on a refueling outage tesis, decision on your pending items to mora appropriate TS locations.
uest for in additnoo. the results of the acosdent ikense amendments date September 1, 't he September 20,1995. a >pliulion arialrwe wh6th are darutnented in the noned to upgrade only son 6 0 UfTAR contious to tuund operation under 1995, to raise the present lower voltage the proguned changes. so that there is no repair limit from 1.0 volt to 3.0 volts. Administrative Controls)of the Quad Cities TS. sateiv snarsin reductmn thereture, the Date of pubhcotton ofitsdividual notice m f ederal Regleter: October 5 Date of pubhcotion ofIndividual proposed chenge does not involve a 1995 (60 FR 52222). notice in Federal Register: October 5 segnsfetant rodartson in a martpn of safety. Espiration date ofindividuol notice: 1995 (60 FR 52226). The NRC ataff has reviewed the November 6,1995. Expiration date ofindividualnotoce; Ilt ensee's analysis end. based on this November 6.1995. review,it appaars that the three localPubhc Document Boorn location: Wilmington Public Ubrary, IncalPublic Document Boorn standards of 50 92tc) are satisfied. 201 S. Kankalee $tts et. Wilmington' location:Dison Public Ubrary,221 Therefore,the NRC staff proposes to lilinois 60451. Hennepin Avenue, Dixon, Illinois 61021. no ns h 8 g a **F North Atlantic Energy Service Docket Noa. 50-237 and 50-249, ' local Pubhc Document Room Drnden Nuclear Power Station. Unite J Co iorallon, Docket No. 50-443, f locotton:ne Alderman ubrary,Special and 3 Grundy County, Illinois Sea Station Unit No.1. Collections Deparmnt, Unhersity of Rockingham County, New Hampehire Virginia. Charlottes,,sile, Virginia Wrket Nos. 50-25 and 50-265 22005-249s. Quod Cities Nuclear romer Station, Date of ornendment tronost: Umts 1 and 2,11ock Island County' S $ s e r5 1995. Attornerforikensee:Mkheel W. flhnois Desenpriore cf omendment request: Maupin, Es . Hunton and Williams. Date of ornendment request: The roposed amendment would Rherfront I ara. Fast Tower,951 E. S tember 15,1995. the Appendia A Technical B d Street, Rirhmond. VirEints 23219. C Pmicct Director: David B. scr:ption of amendment request:To modi 5 cci [ cations (TSsl for the Tur Matthews. rione out open itemsidentified b the C & W Y Yh S inMY, b NRC staff's review of the upgrad f to esed amendment would chan e Previously Publielied Notices of sections 1.0,3/4.4. 3/4.10. and 5 0 of the a mot Statson Appendit A Tec nical Caesidwetloa Wlanuance M Dresden and Quod Cities Technkel Specification Table 3.7-1 to reduce the Amendments to facility Operating Specifications to the BWR Standard maximum allowable Power Range t 1.lcenses Proposed No Significant ifications Neutron Flus-High setpoints with Hazards Cunsideration Determination
- Date of pu Techniul 5(cotion ofindmdual notsce in Federal Register. October 5, inoperable Main Steam Sately Valves and Opportualty for a Hearing IMSSVs) and Table 3.7-2 to reduce the Ths followsng notices were previousiy 1995 (60 FR 52220). opening set nts of the MSSVs.
publhhed as separate indivl<tual Esporotson date ofinJsvidual notu Date of p bhcotion of mdividual November 6.1995. notsce in Federal Register: Octoter 2. notices. The notke content m as the local Pubhc Document Room ume as above. They were published as 1995 {60 FR 51505). location for Dresden, Morris Area Emp#rorson date ofindsviduol noitre individual notices either because time Public Ubrary District. 604 Utert Not ember 1,1995. did not allow the Commission to wait Street, Morris, Illinois 60450. for und for this beweekly notice or tecause the forni Pubhe Document Room ein, Dison Public Ubrary,221 location Exeter Public Ubrary, action invoked estent cimumstancn. They are repeated here twAine the Hennepin Aunue. Diaon. Illinois 61t.21 foundws Park. Exeter, NH 03833. hiwnkly notics lists all amendrnents Coinsnonwealth Ulison Caenpany, Drwket Noa. 50-254 and 50-265, Quad Notice d lasuance of Asnendmente le facility Operating Ucanoes i vo ing no 3 ifi an a s Cit n Nuclear Pow Station. Unita 1 m sid M om and 2 Rock taland County,!!!inois During the period since publication of For details, see the individual notion the lut biweekly notice, the lhte of airwndment request: in the Federal Regis6er on the day and September 20,1995, Commission has issued the following page cited. This notice does not estond amendments ne Commission has Drscription of amendment request: the notico period of the original notka h propowd amendment would detarmined for sech of these upgrade the Quad Cities TS to the amendments that the application ComewieweaM Maos Com m y, compiles with the itendards and Decket Nea. STN M-454 STN 56- Standard Technical S 457, Braidweed 54aties. Umet Nea.1 contaired in NUREG 0123, pecifica T hetions (STSI requirements of the Atomic Enw Act of 1954, as amended (the Act), an the and 2, h 60 Cevuty, Ilhneis Technical Specific 4thn Upgrade Commission's rules and regulettoes. Date of ometidment request. August Program (TSUPIis not a complete 15,1995 adaption of the STS. The TS upgrade N Commission has made appropriate focuses on (11 intettrating additional findings as required by the Act and the Commisanon's rules and regulatione in
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Federal Resist:r / Vol. 60, No. 206 / W:dn:sday Octobet 25, 1995 / Notices 54727 le CML Gapset I, which are act forth in The Censusaseva reistead sealmetion of recaty Operating beenw No. DPR. the Ikonsa amendinent, t the arnoedessuets la coetannad in a Saiety JJ andIV1849: Amendment revised the Notka of Consideration of issuance of Evaluation desed Octsdier 4.19es. Anwedawnt to Iocihty Operating Technkel Speciliulions. No significant hasarda caswideratioes Ate of trutsol notsty in Toderal Lkanas. Proposed No 56sulhcant coenments eweived: No. Register, Mank 15.1995 (60 TR 14016) Hazards Consideration Determination, kcalPu6/sc Dncument Aoorn The Commission's related evaluation of and Opportunity for A flearing in location:Phoenis Public Library,1221 connection with these actions was N. Central Avenue. Phoenix, Arizona these amendments is contained in a published in the federal Register as Safety Evaluation dated October 5.1995. 85004. No significant hazards consideration indicaled. Unless otherwise indicated, the Bahimon Gas and Eleckk Canpany, comments t$ceived: No. Commission has determined that these Dodel Nos. 50-317 and 50-318. Calvert gc,7 p,37j, pgc,,,,, g,,, amendments satisfy the criteria for Cliffs Nuclear Power Plant. Unit Nos.1 locotion:Calvert County Library. Prince categorical exclusion in attordance and 2,Calvert County. Maryland Trederick. Maryland 20678 I with 10 CFR 51.22. Therefore, pursuant Date ofopplication for amendments: Commonwnith Edison Company. to 10 CFR 51.22[bl, no environmental June 2,1995 impact statement or environmental Docket Nea 50-295 and 50-304. Zion Bnef description of omendments:The Nuclur Power Station Unita 1 and 2. assessment need be prepared for these Lake County. lHinois amendments revise the tolerances for amendments if the Commission ha. the pressuriset safety valve as found prepared an environmental assessment Date of application for omendments: acteptsnce criterion. undet Ihe spnial cartumatances March 8,1995, as supplemented on June Nie ofissuonce: September 26,1995. 1.1995. provision in 10 Cl R 51.12(b) and has Ff/cetive date: As of the date of Brief description of amendments: The made a determination based on that issuants to be implem:sted within 30 usessment, it is so indicated. amendments revise the secondary i For further details with respect to the days. undervoltage setpoint, I action see (1) the applications for Amendinent Nos.: 206 and 184. Ate ofissvonce:Octoter 2.1995. arnendtnent. (2) the amendment, and (3) facihty Operating Utense Nos. DPR. Effective date: October 2.1995 the Commission's related leiter. Safety 53 and DPA49: Amendments revised Amendinent Nos.:169 and 156. Evaluation and/or Environmentas the Technical Specincations. Focility Operating Ucense Nos. DPR. Assessment as indicated. All of these Date ofinitial notice in Federal 39 and DPR-48:The amendments Items are available for public inspection Reglater: July 5,1995 (60 TR 35060) The revised the Technical!pecifications. at the Commission's Public Document Commission's related evaluation of Nte ofinitiol notice in Federal Room, the Gelman Building 2120 L these amendments is contained in a Register: August 30.1995 (60 FR 45178) Street, NW.. Washington, DC, and at the Safety Evaluation dated Septemter 26 The Commission's related evaluation of local pubhc dccument rooms for the 1995. No significant harards consideration the amendments is contained in a Safety particular facilities involved' Evaluation dated October 2.1995, comments received: No. No significant hasards consideration Arizona Public Service Company, et al., beof fubhc &cument Room comments received: No. Dochel Nos. STN 50-528. STN 50-829 location: Calvert County Library. Prince and STN 50-530, Palo Verde Nuclear Frederick. Maryland 20678. locof fublic Document Soorn Generating Station. Unita 1.2 and 3, location: Waukegan Public Library,128 Maricopa County. Arisona Baltimore Gas and Electric Company, uny h. Waubgan. Mnois Date of opphcotion for omendments: Docket Nos. 50-317 and 50 318. Caleert B M B5. August 3.1905. Cliffs Nuclear Power Plant. Unit No.1. Consolidated Edison Company of New Brsef descroption of amendments: Calvert County, Maryland York. Docket No. 50-247. Indian Point These amendrnents add the analytical Ate o/ OPPl icationfor amendinents: Nuclear Genereting Unit No. 2 d Watcheeler County, New York a utt?AllowYe u ,' Br e des'eropt n of omendments:The
&te ofopplication for amendment:
CEN-372-P-A. dated May 1990, and its amen ments revise the Technical February 18,1994 as supplemented associated NRC Safety Evaluation, dated SpnincaHon? (TSs) to increase the lune 3. November 1. December 2 April 10,1990. to the list of analytical amount of Trisodium Phosphate December 14 and December 16.1994, methods in Technical Specification Dodecahydrate located in the and August 25,1995, 6 91.10 used to determine the Palo containment sump laskets w hich is Brief description of amendment:The Verde Nuclear Generating Station core required to te vertfled by TS operating !!mits survelllance. The test requirements for amendment revises the surveillance Date of asuance: October 4,1995. verifying that the appropriate pH intenals for the Doric Acid Tank kevel. Effective date: October 4,1995, to t, the Service Water inlet Temperature (acidity / alkalinity) would be maintained Monitor instrument, the Doric Acid implemented pnor to startup from RF06 in the containment sump weer Makeup Flow System.the Plant Noble for Units 1 and 2. and RF5 for Unit 3. following a design. basis accident are Gas Activity Monitor, the Condenser Amendment Nos.: Unit 1- moved from the TSs to the TS Bases Amendment No.101: Unit 2- Evacuation System Activity Monitor, section; however, the requirement to the low Turbine Auto Stop Oil Pressure Amendment No. 89. Unit 3-Amendment No. 72. perform the test remains in the TSs The Trip, the 6.9 kv Undervoltage Monitor, associated TS Bases sections are the Sampler Flow Rate Monitcr. and the Focahty Operating License Nos. NPr. updated Io toflect the changes. 41.NPF-31 andNPr *4:The Refueling Water Storage Tank. Date ofissuance: October 5.1995, amendments revised the Technical Date ofissuance: October 12,1995. Specifications, Effccisre dore: As of the date of issuance to tw implemented within 30 Effective dore: As of the date of Daft ofimtsalnotsce in Federal days. issuance to be implemented within 30 days. Regnaler: August 30,1995 (60 FR 45173) Amendment Nos.: 207 and 185. Amendment Noa 184. I
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$4724 Federal Rekister / Vol f>0. No. 206 / Wednesday, October 25, 1995 / Notices Facihty Operating Ucense No DPR-Detr ofinitial noucr in teertal 16: Amendment revised the Technical Regleten September 4.1991 (56 TR seven 6:aprovements from tbe Revised Specifications. Standard Technical Specifications for 43tt08) and July 6,1995 l60 FR 29675).
Date ofimtsal retire in Feeeral Babcock & Wilcox Nuclear Power Plants Regissee: April 28.1994 (59 FR 22003) The Comminion's related evaluation (NUREG-1430). The amendnent also The Commission's related evaluation of of the Safety Evaluation datedamendment Octoier 4.1995. is changes contained in a incorporating the the Bases the seendment is contained in a Sale'y No signifkant hazards consideration results of analpes to support allowance Evaluation dated October 12.1995. for drift of the Pressurire Code Safety No sigallicant haurds consideretke comments noived: No. Valve setpoint. Tte remaining portion comments rweived: No. localPwNac Document Aoran of the request relating to revisio is to locotton: University of New Orleana localPubhc Document Room Library, toultlana Collection, taleiront. Control Roore Emergency Ventilation Jocataon: White Plains Public Library. system are teing reviewed separately. toe Martine Avenue, White Plains, New New Orleans L.A 70122. Ate o//ssuonce:Octoter to.1993. York 10610 et er a Effecti"e date:Octoter 10.1995.
. M al..
Duket No, ne-219, Three Mile talaed Amendment No.: 196. I:ntergy Operstiana, lec., Dukat No. Facihty Operating Ucense No. DPR-So-3es. Arkaeses Norleer One, Ueet Nwlear 54 sties. OsN No.1. DaupMe No. 2. Pope Couetyn Arkansaa County, Peeeeyteamie 30 Amendment revised ihe Technical Specifiutions. Datc of opplicatinn for amersdment: Dute of apphcotson for amendment: Dotr ofiniUcinotM in Tederal March 17.1995. June 1,1995, as supplemented August Regieter- March 15,1995 (60 FR 140211 23.1995. Onef destnption of omendment: The no Jure 22 and Septemter 20,1995. amendment tevises requirernents Uneldesenption of e nendment:The letter provided clarifying informatson associated with channel functional testa amendment changes the Technical of the core protection calculator Speellications to relocate the procedural no signiflunt hazards consider following a high temperature alarm. details of the Radiological Effluent determination. Technical Specifications to the Offsite Date ofissuance: Octoter i t.1995. The Commission's related evaluation f//ective dote: Octoter 11.1995, to be Done Calculation Manual. With these of this amendment is contained in a Implemented within 30 days. changes, the specifications related Io Safety Evaluation dated Octoter 10. Amendment No : 168. RETS reporting requiremerts were 1995. rocahty Operating Drense No NPP.d simpilfled and changes to the definition No significant hazards consideration Amendment revised the Technical of the ODCM were made to make the comments received: No. Specifications. definition consistent with the localfubhc Document Room amendment. Date ofimlioinotice in Federal location: law /Covernment Publications Register: August 2.1995 (60 FR 39437) Dute oflasuance: October 2.1995. Section. State Library of Pennsyitania. Effective dote: As of the date of (Regional Depository) Walnut Street and
%e Commission's related evaluation of the arnendment is contained in a Safetyissusncedays. to be implemented within 120 Commonwealth Avenue. Box 1601, Esaluation dated Octnter 11,1995. Harrisburg, PA 1/105.
No significant hazards consideration Amendment No.: 197. Torihty Operating Ocense No. DPR- I ""* " comments received: No. gN local Pubhc Document Room 30 Amendment revised the Technical 31 5 16 nald Specifications. C. Cook Nuclear Plant, Unit Nos.1 and location Tomlinson Library. Arkansas Date ofinitial notice in Federal 2. Berrien County, Michigan Tech University.Russellville. AR 72R01. stegister: July 5,1995 (60 FRDate 35078) The of application for amendinents:
.sugust 23,1995, letter provided November 12,1993, as supplementet.
32 a er tear supplemental information that did not gtation, gnit 3, St. Charles Parish. Novemter 18,1994. May 30,1995, and
# "I'I * "
- chan[e the initial proposed
,;gng cant hazards consideration no Au ust 8.1995.
nef descnption of amendments: The Dole of amendment request:luly 18 determination. amendments delete from the Technical 1991, as supplemented by letters dated The Commission's related evalui 4 a Specifications the sections and tables March th.and December 2.1994.and of this amendment is contained in a entitled " Component Cyclic or March 9.and August 30,1995. Safety Evaluation dated October 2.11,95. Transient Limits" and relocate the Bnef description of ornendment: The No sign'ficant hazards consideration information to the Updated Final Safety amendment changes the Appendit A comments received: No. Analvsla Report. TS: by subdividing TS 3r4.7.6. " Control local Pubhc Document Room Do're ofissuance: September 28.1995. Room Air Conditioning System,"into location: LawlGourament Publications Effective dote: September 28.1995. Section. State Library of Pennsylvania, with fullimplementation within 45 five separate TSs covering the following (Regional Depository) Walnut Street and days. three distinct functions control room emergency air filtration, control rnom Commonwealth Avenue. Box 1601, Harrisburg, PA 17105. Amendment Nos.: 201 and 186. air temperature, and control room Tacihty Operating Ucense Nos. DPR-isolation and pressurtration The GPU Nuclear Corporation, et al $8 and DPR-74. Arnendments revised amendment also changes the Ilases Docket No. 50-289. Thrwe Mile Island the Technical Specifiutions. sectinns of the TS to reflect the above Nuclear Station. Unit No.1. Daupl.in Date ofinitioInotice in Federal changes. County. Pennsyleania Register: December 22.1993158 FR Date of assuance: October 4.1995. Date of applicotion for omendment: 67449). The November 18,1994. May F/fective date October 4.1995. 30.1995, and August 8.1995 Amendment No : 115. january 16.1995, as supplemen? June supplements provided clarifying 22 and September 20.1995. Focshty Operatsng brense No NPF- information and corrections to Bnef desenptoon of amendment: The addntional pages which referenced the .W Amendment Specificatic ns remed the Techrocal amendment tovises the Technical Specifications for TM1-1 to incorporate table to be deleted This information was within the vope of the original
Federal Register / Vol. 60. No. 206 / Wedn:sday. October 25, 1995 / Notic:s 54729 l apphcation and did not change the 45179). The Commission's related fire protection program elements from stafra inlual proposed no significant evaluation of the amendment is the Technical Specincations and haurds consideration determination. contained in a Safety Evaluation dated incorporate by reference.the NRC-The Commission's related evaluation of October 2.1995. appros ed Fire Protection Program and the amendments is contained in a Safety No significant haurds consideration ' Evaluation dated Septemtwr 2A.1995. comments received: No, maior commitments, including the fire No significant hazards consideration har.ards analysis. into the Updated Loco / Pubhc Documeat Room Safety Analysis Report. commenis rnelved: No. location:Wiscasset Public Ubrary High e local Pubhc Document Room Date ofissuance: October 6,1995. Street. P.O. Box 367. Wiscasset. ME location:Maud Preston Palenske 04578 Effective date: October 6.1995, with m ri bre 5 0MarLes Street,bl. fuliimplementation within 30 days. Y* * ' Northers Stalas Power Company. Amendment Nos.: 120 end 113. Dochet No. th-283, Montbcelle Nuclear Indiana Mkhlgan Power Cornpany ~ Pacihty Operating IJtense Nos. DFB-Dodet Nos. W318 and S314. Donald Generating Plant. Wright County. 42 and DPR40. Amendmes.ts revised Minnesota C. Cool Nuclear Plant. Unit Nom. l and the Technical Specifications.
- 2. Berrien County. Mkhigan Dotr of opphcotion fot omendment: Dutr ofinit ol notice in federal June 8,1994, sa superseded by letter Register: December 21,1994 (59 FR Date of opphcotion for omendments:
May 26.1995- dated April 20.1995, and supplemented 65818). The April 18.1995, letter Brief descr plion of amendments:The by letter dated August 18.1995. provided clarifying information within Rrief descrrption of amendment:The the scope of the original submittal and amendments modify Technical Specifiution Sections 3/4.3.1 and 3t amendment revises Sections 3.7/4.7 did not change the staffs initial which pertain to the standby gas proposed no significant haurds 4.3 2 at d their accompanying Bases, to relocate the tables of response time trestment system (SCTS) and secondary consideration determination The containment. The amendment revlees Commission's related evaluation of tl.e hmits for the ructor trip system and the surveillan ;e requirements for both engineered safety feature acutation amendments is contained in a Safety SGTS and the secondary containment system instrumentation to the Updated and revisas the performance Evaluation dated Odober 6.1995. No significant hasards consideration FinalSafety Analysis Regrt. r,quirements for the SGTS filters and comments received: No. hf I oYeY$ntIt.195 P"$' h*y' i h local Pubhc Document Room Amendment Nos :202 and 187 Pocrhty Opemeing Ocense Nos. DPfl- gjfecg' 4 g, WCW MH MMM. g,,,d e I hoc,ny,q o :94 g* gpg5' Technolo6y and flence Department. 58 and DPR-74. Amendments revised 300 NPallet Mall. Minneapolit. the Technical Specifications. Pacihty Operating dcense No. DPR-Jf. Amendment revised the Technical W nn w a $5401. Date ofImrialnotice #n iederal Register July 5.1995 (60 FR 35082)The Specifiutions. Sacramento Municipal Utility District. Commluion's related evaluation of the Date ofinitiolnotier in Federal Docket No. 60-312. Ran ho Seco Re amendments is centained in a Safety %gleter: July 20,1994159 FR Nuclear Generating Station, 37075). Evaluation dated October to.1995. e April 20 and August 18.1995. Sacrossento County. California
, No significant haurds consideration submittals Provided clarifying g
g within the scope of the Date of applicationfor omendment comments received: No' t Room loco / Pubhc Documen original submittel and did not change June 20. Im the stafTs initial proposed no significant Brie desenption of amendment:This Me I u a'Y' 5 M t Street' St* heurds consideration determination, amen ment modifies the technical loseph. Michigan 49085, The Commission's related evaluation specifications on spent fuel storage of the amendment is contained in a building load handlit.g limits to allow Maine Yankee Atomic Powei l'empany. Safety Evaluation dated Octotwr 2.1995, the placement of the top shield plug on Docket No. 50-309. Malne Yankee No significant heurds consideration a dry shielded canister containing spent Atomic Power Station, uncoln County. comments received: No. fuel which is being prepared for transfer Maine localPubhc Document Room to the Rancho Seco Independent Spent Dofe of opphcotion for amendment; location: Minneapolis Public ubrary, Fuel Storage Installation. May 5.199L Technology and Science Department. finef desenprion of amendment:The Dofe ofissuance: October 5.1995. 300 Nicollet Mall, Minneapolis. amendment revises the surveillanca Minnesota $5401 Effxtin date: October 5.1995 frequency of radiation area, and efiluent Amendment Noa 123. and process monitors from monthly to Northern States Power Coanpany. Pacihty Opemting Ocense No. NPP-1: quarterly; and the required fr,quency Docket Nos. 50-232 and 60-306. Prairie The amendment revised the Tec}mical laland Nuclear Generating Plaat. Unit Specifications. for minimum exeruse of control Noa.1 and 2.Goodhue County. element assemblies also from monthly Minnesota. Date ofinitial notice in Federal Register: August 30,1995 (60 FR I eo sIsuance: October 2.1995. Dete of oPPhcotion omendments: 45184), he Commisalon's related Effectne date: As of the date of July 11.1994, as su emented April evaluation of the amendment is issuance, to be implemented within 30 18.1995 (supersed the February to, containod in a Safety Evaluation dated da ys. 1993. application). October 5.1995. . Xmendment No : 153. Bnef description of amendments:ne No significant haurds consideration Pocihty Operating Ocense No. DP11- amendments change license conditico comments received: No. 36: Amendment revised the Technical 2 C.(4) of each license to conform to the Specifications and/or utense, standard fire protection license local 8She twoore Room Dole of sturial notice in Federal locotsore Cantrsh Ubrary. Government Register. August 30,1995 (60 FR condition as stated in Generic Letter 86- Docsna nts,828 i Street. Sacramento.
- 10. In addition. the amendments delete California 95814.
54730 Federal Register / Vol. 60. No. 206 / Wednesday. Octobar 25, 1995 / Notices South Caroline Electric a Cas Com y. South Carollas Public appliutirm and the initial proposed no significant haurds considerstion Date of/ssuance: October 2.1995. Se e Authonty. Docket No. 50-395 Effartiw date: October 2,1995 determination. Virgil C. Sunnmer Nuclear Station, Unit Amendment Nos.t 212 and 202. The Comm.ssion's related evaluation rocility Operarmg Ucense Nos. DPfl. No.1. Fairfield County. South Caroline of the amendments is cantained in a Date of application for amendment: 77 and DPR-79: Amendments revise the Safety Evaluation dated September 28, technical specifications. gno 30,1995. as suppgemented on 1995 August 11,1 5. Nb Date ofinitial notice in Federal heurds consideration Register: August 30.1995 (60 FR 45166) comments received: No. The Commissin amenjment revises the TechnicalBne description g,(,; puy9,, of amendment:Tbe p,,,,,,,, g,,, zy,,,,,g,,,,n's relate,,d
, Specifications (TS) for the pressuriser location: Houston. Love Memorial g , ,,,, , evaluation
,g g, , S,q,,,of power operated tellef valves to follow Library,212 W. Burdeshaw Street. Post Evaluatioo dated October 2.1995.
No significant heurds consideration the NRC s guidance of Generic letter Office Box 1369. Dothan, Alabame 90-06 (Generic lesue 70), and the 36302. comments received: None. improveid Wettinghouse Standard TS locolPublic Document floom Southern Nuclear Operating Cornpany. locarlon: Chattanooga.Harnilton County (NUREG-1431. Rev.11. Library.1101 Broad Street Chattanooga, Date of lssuance: September 18,1995. Inc.. Docket No. 50-344, }ueeph M. Farley Nuclear Plant. Unit 1. Houstoe Tennessee 37402'
- Effective date: Se Amendment No.:ptember 129.
16.199$. County. Alabama Tennessee Valley Authority. Docket facihtyOperatingbeenseNo NTF- Date of amendment request, Nos. 50-327 and 50-328. Sequoyah 12 Amendment revises the TS. December 7,1994. as supplen ented by Nuclear Plant. Unita 1 and 1. Hamilton Date ofimtsal notice in 1ederal lettet dated May 31,1995. County. Tennesaw Register: Auust to. 1995 (60 FR 42608). Drief Desenption of ornendment:%e Date of application for amendments: The August 11,1995, supplemental amendment revised Farley Unit 1 August 7.1995 (TS 95-12). letter corrected an error in the original Technical Specifications 4.4 6.2,4.4.6.4, Briefdescnprion of unendments:The submittal and did not change the initial 4.4.6.5. 3.4.7.2, and 3.4.9 for Cycle 14 amendments correct various editorial proposed no significant haurds operation to permit the use of steam errors in the text of the technical consideration. The Commission's generator tube repalt criteria for defacts specifications and remove provisions related evaluation of the amendment la confined within the thickness of the that have ex contained in a Safety Evaluation dated ort plate, September 18,1995. tubeDate osupfissuance: September 28 1995 applicable pired Date of/ssuance: October 4.1995.
. No significant heurds consideration Effective date: As of the date of Effeetne date: October 4.1995.
comments rotelved: No. luuance to be implemented prior to the Amendment Nos.: 213 and 203. localPublic Document Room start of Unit 1. Cycle 14 operation, facihty Operating Ucense Nos. DPR-location ~ Fairfleid County Ubrary,300 Amendment No.: 117. 77 and DFB-79: Amendments revise the Washington Strwt Winnsboro. SC Facihty Operating Ucense No. NPF-2: technical specifications. 29180. Amendment rnised the Technical Specifications. Date ofinitio/ notice in Federal Southern Nuclear Operating Com sy. Register: August 30,1995 (60 FR 4s185) Date ofinitiolnotice in Federal lac., Docket Nos. 50-348 and 50-N4, Register: Febrvary 15.1995 (60 FR The Commission's related evaluation of Joseph M. Farley Nuclear Plant. Unita 6754) The May 31,1995, letter provided the amendment 1 and 2. Houston County. Alabama Evaluation dated Octoberis4,1995. contained in a Safet4 clanfying information that did not No significant hazards consideration Date of amendments request: August chang. ;be scope of the December 7 1994 comments received: None. 17,1994, as supplemented by letters pmpodap no llcation significantand the initial her.ards localPubhc Document Room dated June 15 and August 11,1995. location: Chattanooga. Hamilton County Brief Description of amendments: The consideration determination. Library,1101 Broad Street. Chattanooga, amendments eliminate periodic The Commluton's related evaluation Tennessee 37402. pressure sensor response time testing of the amendment 16 contained in a surveillance requirements for specific Safety Evaluation dated September 28 Tennessee Valley Authority. Docket No. i Reactor Tnp System and Engineered 50-327. fequoyah Nuclear Plant. Unit Safety Feature Actuation System 1995'significant No hazards consideration1. Hamilton County. Tennnaw i instrurnentation sprified in Technical comments received: No. l Date of application for omendment: ! Specification Sections 4.3.1.3 and Local Pubhe Document Room July 19.1995, superseded September 7 I 4 3.2.3 locofion: Houston Love Memorial 1995 and supplemented Septe,mter 15 Date ofissuonce: September 28,1995- Library,212 W. Burdeshow Street, Post and 26,1995 (TS 95-15). Office Box 1369. Dothan, Alabama Effectwe dore: As of the date of 36302. Briefdescription ofomendment:The issuance to be implemented within 30 amendment revises the TS surveillance days from the date ofissuance. Tennessee Valley Authority. Docket requirements and bases to inccrporate Amendment Nos.: 116 and 108. Nos. 50-327 and 50-328. Sequoyah attemate S/G tube plugging criteria at Focihty Op rotmg Ucense Nos. NPp. Nuclear Plant, Unita 1 and 2. Hamilton tube support plate (TSP)intersecttons. 2 ond BPF4. Amendmes.ts reviu the County Tennwen The approach taken is similar to Techniul Specifications. guidance given in Generic Letter (GL) Date of opphcotion for amendments: Date ofirutial notice in Federal August 7,1995 (TS 95-18). 95-45. " Voltage-Based Repair Criteria Register September 28.1994 (59 FR Brief description of omendmentse ne for Westinghouse Steam Generator 49434)The June 15 and August 11, Tubes Affected by Outside Diameter 1995, letters provided clarifying amendments revise the titles of various Stress Corrosion Cracking."
- administrative positions found in information that did not change the Date ofissuonce
- October 11,1995.
scope of the August 17,1994 Section 6.0 cithe Technical Specifications. Effective date: October 11.1995. Amendment No.: 214. f l 1
Tederal Register / V:1. to, No. 206 / Wednesday, October 25, 1995 / N:tices 54731 facihty Operotmg Ucense Nos. DPR Amendment No.:142. SWhn 4.0.5e,"Survei11ance 77: Amudment revises the luchnical roc /hty Operchng Ocense No. NTF- Requirements for Inservice inspection specifications. Jt The amendment revised the and Testing Propram." This clause Dore ofintriot notice in Federal Technical Specifications. required prior hRC approval before Regiskr: August 1,1995160 TR 39189) Date ofitubal nouce in Federal implementation of a relieIrequnt upun The lettera dated Septemter 7,15 and Register: July 6,1994 (59 FR 34670). finding an ASME Code requimment 26,1995 provided information that did The Commissicn's related evaluation of impractical because of prohibitive dose not change the initial proposed no the amendment is contained in a Safety tates or limitations in the design, significant hazards considwauon. The Euluation dated October 5,1995. construction, or system configuratio i. Commission's related evaluation of the No significant hazards consideration Date issuance: Octoter 4,1995. arnendment is contained in a Safety comments rocsived; No. E ect e dote:Octoter 4,1995, to be Evsluation dated Octoter 11,1995. bro / Public Docurnent Room imp emented within 30 days of No significant hazards consideration loco. ion: Richland Public ,955 issuanm. comments received: No. Northgate Stmt, Richland, Was ington Amendment No.:90. kcal Public Document Room 9g352. Facility Operating Ucense No. NPT-locodon: Chattanooga-Itamilton County 42. no amendment revised the Ubrary,110111 road Street, Chattanooga, Wolf Creek Nuclear rating Technical 5 ifications. Tennessee 37402. Corporade, Docket o. So-4s2A. lf Date ofin 101 notice in Federal Creek Genc+ating Ststiu, Colley Register: August 30,1995 (60 TR V lala Eiectric and Power Cormpany, County. Kansas 45191). The Commission's related Date of amendment te urst:Ma 24, evaluation of the amendment is ort A a P wer et Un is o1 and No. 2,loulas County, Virginia 1994, as supplemented b letter d ted contained in a Safety Et lustion dated A l6,1995. Octobe 4,1995. Ekste of opplication for amendments: ri descripHon of amendm.mt:This No st.pslficnnt hazards cons)deratien March 30, *995, as supplemented amen ent revius the technical comments received: No. August 24,1993 ,ecifications (TS) to implement the bcol Pubhc Document Room Un description amendments:no RC's revised to CFR 50.36 on locations:Em a Stste University, amen rnents reviu o North Anno 1 technical specificadon improvements William Alle White Ubrary,1200 and 2 Technical Specifications to allow for nuclear power reactors. CommercialStreet Em oria, Kansas one of the two service water loops to be S ificadons that do not meet any of 66801 and Washbum t iversity School isolated from the component cooling i e four criteria or regulatory of Law Ubrary. Topeka, Kansas 66621
' " "" requirements related to inclusion in the Neuce oflaeuance of Annendseents to to ln order o r fu bibPbe ,
oblated i service water headus. TS are rol58 cated to Chapter 16 of the Facility Operating Ucenses and Final Date issuance: October 11,1995. M8 Dofe imonm Y An*
- PM*
oter 2,1995. Determination of No Significant i dore:Octoter 11,1995. Hazards Consideradon and - Y date:Octoter 2,1995, to le rnendment Nos.: 194 and 175. riunity for a Hearing fEsigent Torility Operotmg Ucense Nos. NPT- Imp emented within 120 days from the Pu He AnmM or Emupncy 4 and NPF-7. Amendments revised the date uf issuance. Amendment No.:89. Circametanca) Technical S fimti During the riod since publication of Date ofin bolnob di Federal facillfy O eruting P Ucense No. NPr. Register: May 10,1995 (60 FR 24923). 42. The amendment revised the the last biw y notice, the De Commission's related evaluatic.n of Technical S ifications. Commission has issued the following the amendments is contained in e Safety Date of f tioinotice in Federal amendments. The Commission has Evaluation dated Octoter 11,1995. Regietee: July 6,1994 (59 FR 34671). determined for each of these No significant heurds consideradon The April 6,1995, supplemental 1.tter amendments that the op lication fee the mrnments received: No. rovided additional clari ng amendment complies w the brolPubhc Document Room formation and did not go the etAndards and requirements of the , locobon:The Alderman ubrasy, Special initial no significant hasards Alnmic Energy Act of 1954, as amended Collections Department, University of consideration determinadon. (the Act), and the Commission's rules Virginia, Charlottesville, Virginia The Commission's related evaluadon and regulations, no Commission has 22905-2498. of the amendment is contained in a made appropriate findings as required Safety Evaluation dated October 2,1995, by the Act and the Commluion's rules Wuhington Public Power Suppl No algnificant hazards consideration and regulations in 10 CFR Chapter I, System, Docket No. 50-397, Nuc ar comments remived: No. which are set forth in the license Pre >ct No. 2, Benson County. beal Public Documeni Room amendment. ! Washington locobons: Emporta State University, Because of exigent or emergtency Date of application for amendment: William Allen White ubrary,1200 circumstances associated witn the date j Decomter 6,1993. Commercial Street, ris, Kansas the amendment was needed, there was l Brief desenpt on of amendment:The 66801 r.nd Wuhbum iversity School not time for the Commission to publish, ! amendment changw the surveillance of Law Ubrary. Topeka, Kansas 66611. for public mmment before tasuance, its requirements in Technical Speci6 cation usual 30-day Notice of Consideration of Wolf Creek Nuclear rating 4.6.6.1.b.3 to provide more appropriate o, So-442 Won Issuance of Amendment, Proposed No acceptance oiteria for demonstrating
%retma, %t Significant Huards Considerstion
' 880'*U"' W o
b ability of the primary containmsnt ogen recombiner s stems. [I Determination, and Opportunity for a Hearing. le ofissuonce; er5,1995. Date of amendment request:Ju?v 25, For exigent circumstances, the echve date: October 5,1995, to be 1995. Corranission has either issued a Federal imp emented within 30 days of Snef description of amendment:The Register notice providing opportunity luuance. amendment deletes a clause from for public comment or has used local l
54732 Federal Register / Vol. 60 No. 206 / Wednuday. October 25. 1995 / Notices media to provide notics to b public in for further details with tapect to the which petittor ,r wishes to intervene, the area surrounding a licenm's facility action sn (1) The application for Any person who has filed a petition for , of the licensee's application and of the amendment.12) b amendment to lave to intervene or who has toen ' Commluion's proposed determination Facility Operating Ucense, and (3) the admitted as a party may amend the of no significant hasards consideration. Commission's related letter, Safety petition without roquating leave of b , The Commission has geovided a Evaluation and/or Environmental Board up to 15 days prior to the first 4 rwsonable opportuntry for the public to Assessment. as indicated. All of these preheanng confance scheduled in the comment. using its but efforts to make items are evallable for public inspection promeding, but such an amended cvalleble to h public means of at the Commission's Public Document petition must satisfy the specificity communication for h public to Room, the Gelman Building. 2120 t, requirements dncnted above. rnpond quickly, and in b case of Street. NW., Washington. DC, and at the Not late than 15 days prior to the first telephone comments, the comments local public document room for the prehearirg animace scheduled in the have been recorded or transcrited as - particular facility involved, proceeding.a p ssr cer shall file e appropriate and the licenm has toen The Commission is also offering an supplement to t.. . ruluon to intervene informed of the public comments. opportunity for a hearing with twpect to which must include a list of the in circumstances where fallum to act the issuance of the amendment. By contentions which are sought to be in a timely way would have anulted, for Novemter 24,1995, the licenses may litigated in the matter. Each contendon nample In dmting or shutdown of a file a request for a haring with respect must consist of a specinc statement of nuclear power plant or in prevention of to issuance of the amendment to h the issue of law or fact to be raised or either ruumption of operation or of subject facility operating license and controverted. In addition, the petitioner , inunse in power output up to b any person whose intest may tw shall provide a brief explanation of the . plant's licensed power level, the effected by this procwding and who bem of h contention and a concise Commluton tuay not have had an wishes to participate as a party in the statement of the alleged facts or expert opportunity to provide for public promeding must file a written request opinion which support the contention t.omment on its no significant huards for a heering and a petition for leave to and on which h peutioner intends to consideration determination. In such intervene. Requests for a hearing and a rely in provir 4 h contention at the case, tholicense amendment has toen petition for leave to intervene shall be hearing. The p 'jtioner must also issued without opportunity be nled in accordena with the provide nferences to those specinc comment. If bro has toen some Ume Cc'umission's " Rules of Practice for sources and documents of which the for public emnment but less than 30 Domntic Ucensing Proceedings"in to petitioner is aware and on which the days, the Commission may provide an CFR Part 2. Interested persons should pedtioner intends to rely to establish j opportunity for public comment. If consult a cumnt copy of to CFR 2.714 those facts or expert opinion. Petitioner
, comments have leen requested. it is so which is available at the Commission's must provide sufficient information to stated. In either event, the State has Public Document Room, the Colman show that a genuine dispute estats with twen consulted by telephone wbenever Building. 2120 L Street, NW., the applicant on a material lasue of law possible. Washtr ston, DC and at th a local public or fact. Contentions shall tw limited to Under its regulations, the Commission document room fx the particular matters within the scope of the may luue and make an amendment facility involved. lf a request for a amendment under consideration. The immediately effective, notwiktanding hearing or petition for leave to intervene contention must be one which,if the pendency t= fore it of a request for is filed by the above date, h proven, would entitle h petidoner to a hearing from any person,in advance Commlulon or en Atomic Safety and relief. A petitioner who fails to file such of the holding and completion of any Ucensing Board, designated by the a supplement which satisfies thne required hearing, where it has Commluton or by the Chairman of the requirements with respect to at least one determined that no significant hazards Atomic Safety and ucensing Board contention will not tw permitted to consideration is involved. Panel, will rule on the request and/or participate as a party.
The Commission has applied the petition: and the Secretary or the Those permitted to intarvene tecome atandards of 10 CFR 50.92 and has made designated Atomic Safety and ucensing parties to the proceeding. subject to any a final determination that the Board will issue a notim of a hearing or limitations in the order granting leave to amendment involves no significant an appropriate order. Intervene, and have the opportunity to hazards consideration. The basis for this As required by to CFR 2.714. a participate fully in the conduct of the determination is contained in the petitinn for leave to intervene shall set ha;aring, including the opportunity to documents related to this action. forth with particularity b intemt of prnent evidence and cross-examine Accordingly, the amendments have h petitioner in the proceeding, and witnesses. Since the Commission has been issued and made effective as how that internt may be affected by b made a final determination that the indicated. results of the proceeding. The petition amendment involves no significant Unless otherwise indicated, the should specifically explain the reasons hazards consideration,if a hearing is Commission has determined that these why intervention should to permitted requested,it will not stay the amendments satisfy the criteria for with particular reference to the effectiveness of the amendment Any ; categorical esclusion in accordance following factors:(1)The nature of the hwring held would take place while b ) with to CFR 51.22. Therefore, pursuant petitioner's right under b Act to to amendment is in eflect, to 10 CFR St.22(bl, no environmental made a party to b prucmding:(2) the A request for a hearing or a petition ) impact statement or environmental nature and extent of the petitioner's for leave to latervene must be filed with 1 assessment need be prepared for these property, financial, or other interest in the Secretary of the Commisalon,ll.S. I amendments. If the Commission has the procwding: and (3) the possible Nuclear Regulatory Commission, l prepared an environmental assessment effect of any order which may be Washington, DC 20555, Attention: l under the special circumstances entered in the proceeding on b Dncketing and Services Branch, or may provision in to CFR St.12(b) and has petitioner's interest. The petition simuld be delivered to the Commission's Public made a determination based on that also identify b specific aspect (s) of the Document Room, the Gelman Building, asseument. it is ao indicated, subject matter of the proceeding as to 2120 L Street, NW.. Washington IX:, try
pederal Register / V;1. 60. No. 200 / Wednesday. Octobet 25, 1995 / N tices $4733 the aheve date. Where petitions are filed NRC Project Director: Brian E. Ilollan, during the :sst to days of the notke Acting. period, it is requested that the petitioner promptly so inforrn the Commission by Pacific Gas and Electric C*rnpany, a toll free telephone call to % estarn Docket Nos. 50-275 and 50-323. Diablo Union at 1-400) 248-5100 (in Missouri Canyon Nuclear Fower Plant, Unit Nos. 1-(800) 342-6700) The Westem Union h",(d 2. i,San Luis Obispo County, o verslot should be given Datagram i entifita1Lon Numbst NtoiJ and the Date of opplicottonfor omendments: fohawing message sJdressed to (Pro /cca September 30,1995. Dnrectory. petitioner's name and Bri descriptior. of omendments:The telephone number, date petition was amen ments increase the setpoint mailed, tant nams, ano publication iolerance of the main steam safety date an page number of this Federal valves (MSSVs) from plus or minus 1 Register notice. A copy of the petition Percent to plus or minus 3 pernnt, with should slso be sent to the Office of the the exception *. hat the lowest set MSSVs General Counsel. U.S. Nuclear would have a tolerance of -2 percent / Regulatory Commission. Washington. e 3yercent. DC 20555, and to the attorney for the vote ofissuance October 1.1995. lic6 tace. Effective defe: October 1.1995. Nontimely filings of petitions for Amendment Nos.. Unit 1-leave to intervene. amend >d petitions, Amendment No.108: Unit 2-supplemental petitions and/or requests Amendment No.107. for a hearing will not be entertained Facihty Operating Ucense Nos. DPR-absent a cLlermination by the 80 and DPR42:The amendments Commission, the presiding officer or the revised the Technical Specifications. Atomic Safety and Licensing floard that Public comments requested as to the petition and/or uest should be proposed no significant hazards gratted baed upon a lancing of the conalderation: No. factors specified in 10 CER 2.714(a)(1) The Commission's related evaluation (IHv) es.d 2.7u(d). of
' the amendment, finding'of emergency
****"'"'"" 0"'I " ""I" "
Detroit Edison Company, Docket No. In significant hazards consideration 5F341. Fermi-2. Monroe Count 7 are contained in a Safety Evaluation Michigan dated October 1.19h Date of application for omendment: Locol Pubhc Document Room Octola?r 2,1995. locotion:Califomia Polytechnic State Bn description of amendment:The University. Robert E. Kennedy Library. amen ment revises the Technical Government Documents and Ma Specifications to allow deferral until the Dep.mont San Luis Obispo, lifornia next plant outage of certain portions of 9;1407. logic system funstional surveillance testing for the diesel gt nerator 480-volt Attorn forlicensee:Christa her1 Warner. .. paciBc Gas and E ectric load sequencer and output breaker Company P.O. dox 7442. San reclosure logic circuitry. Francisco, California 94120. Date ofissuance: October 13.1995. NRCProject Director: William H. Effective date: October 13.1905, with Bateman, fullimplementation within 45 days. Amendmens No.:105. Deted at Rockville. Maryland, this 18th day facihty Operating Ucense No. NPF- *IOC'*b*' MS-43 Amendment revises the Technical For the Nuclear Regulate y Casamission. Specifications. Ehaer G. Ademean. Public comrnents requested as to DeputyDuector. Division ofReactor proposed no significant hazards Propeer*-WA' Office of Nuclear fleoctor consideration: Nn. Regulatic.n. The Commission's ' elated evaluation IrR Doc. 95-26275 Filed 10-24-05. 8 45 am) of the amendment, finding of emergency sus e coes rees.w circumstances, and final determination of no significant hazards consideration are contained in a Safety Evaluation dated October 13,1995. kol Pubhc Document Room locatmn: Monroe County Library System. 3700 South Custer Road. Monroe, Michigan 48161. Attorneyfor sicenser:lohn ilynn. Esq., Detroit Edison Company 2000 Second Avenue. Detroit, Michigan 48226,
- . - . . . . . . _ . . . - . _ . . ~ _ .. . - . . . ~ - . . - . - - . . . - - . - - - . . . - , , _ . . .
f h k.
-. UNITED STATES ;
- j. . .
y NUCLEAR REGULATORY COMMISSION-
- W# SNINGTON, D.C. 3000HOM
***** February-23, 1996 i.
h Honorable Iauch Faircloth,-Chairman *~ subcommittee on Clean Air, Wetlands, Private
-Property and Nuclear safety
. Committee on Environment and Public Works United states. Senate - Washington, DC 20510 + 1
- 4. Dear Mr. Chairman l I as forwarding the' Nuclear Regulatory Commission's (NRC's)
" Report to Congress on Abnormal Occurrences, July-september 1995," for events at-licensed nuclear facilities for the third quarter of calendar year 1995. These quarterly reports are i required by'section 208 of the Energy Aeorganisation Act of 1974 (PL 93-438). In the context of the Act, an abnormal occurrence (AO)-is an unscheduled incident or event that the Commission determines to be significant frca the standpoint of public health or safety.
This report addresses three Aos at NRC-licensed facilities. Two involved medical brachytherapy misadministrations, and one involved ingestion of radioactive material by research workers. One AO-submitted by the Agreement states involving importation
- into the United states of a package having excessive external radiation is includod. No updates of-previously r6 ported Aos
! (Appenoix B) or "other Events of Interest" items (Appendix C) are
- heing reported.
l sincerely, f f nnis K. Rathbun, Director yr office of Congressional Affairs Enclosure
'As. stated i
ces senator Bob' Graham i. r 4 A n a s M Gt, w on u -. ~ . - - -
,~
- , , , - --- - --.- ~ ,.,.- - - - - , - - - - - - . - - . - , , . , , . . - - - . .
~*
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^
NUREG-0090 ! Vol.18, No. 3 5 Report to Congress on Abnormal Occurrencee 6 July - September 1995 U.S. Nuclear Regulatory Commission Office for Analysis and Evaluation of Operational Data p# ~%.,, s ..... l l 1
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pa tee,9 5 / 't UNITED STATES i i** B NUCLEAR REGULATORY COMMISSION i( [ waswiwovow, o c. no cooi 5A .o# April 10, 1996 The Honorable Lauch Faircloth, Chairman committee on Clean Air, Wetlands, Private Property and Nuclear Saftty ' Constittee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
The Omnibus Budget Reconciliation Act of 1990, as amended, requires that the NRC recover approximately 100 percent of its budget authority, less the approsriation from the Nuclear Waste Fund, for each Fiscal Year 1991 through 1998 sy assessing license and annual fees. For FY 1996, the NRC must collect approximately $462.3 million through these fees. This is $41.3 million less than the amount to be recovered for FY 1995 and $50.7 million less than the FY 1994 amount. The budget reduction results in reduced annual fees for NRC licensees. In order to comply with the law, the Cossaission is amending its fee regulations in 10 CFR Part 170 and 171. The final amendments to 10 CFR Part 170 will revise the professional hourly rates and " flat" licensing fees to reflect the costs of providing NRC licensing services to applicants and licensees. The final amendments to 10 CFR Part 171, which assess annual fees for costs not recovered through 10 CFR Part 170, will establish the amount of the FY 1996 annual fees to be assessed to operating reactors, fuel cycle licensees, transportation certificate holders, and materials licensees. All of the FY 1996 annual fees will decrease by about 6 percent as compared to FY 1995. The reduction in the annual fees results from changes in (1) the budget to be recovered from fees; (2) the amount of the budget recovered by 10 CFR Part 170 fees and other offsetting receipts; and (3) the number of licensees paying fees. Those NRC licensees that can qualify as a small entity under the NRC's size standards will continue to be eligible to pay reduced annual fees. Enclaed is a copy of the final rule which is being transmitted to the Federal Register for publication. The final rule will become effective 60 days after publication. Sincerely, l ' Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Final Revision to , 10 CFR Parts 170 and 171 ) I cc: Senator Bob Graham l
l: -. l 4 [7590- 01-P)
- l NUCLEAR RFGULATORY COMMISSION 10 CFR Parts 170 and L71' RIN: 3150-AF39 i
Revision __of Fee Schedules; 100% Fee Recovery,-FY 1996 i AGENCY: Nuclear Regulatory Commission. ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Conunission (NRC) is amending the licensing, inspection, and annual fees charged.to its applicants ,
and-licensees. The amendments are necessary to implement the Omnibus Budget Reconciliation Act of 1990 (OBRA-90) , which mandates that the NRC recover approximately 100 percent of its budget authority in Fiscal Year (FY) 1996 less amounts appropriated from the Nuclear Waste Fund (NWF) . The amount to be
-recovered for FY 1996 is approximately $462.3 million.
EFFECTIhEDATE:. -(60 days after publication in the Federal:
- Register) .
ADDRESSES: Copies _ of consnents received and the agency workpapers that support these final changes to 10 CFR Parts 170 and 171 may be examined at the NRC Public Document Room at 2120.L Street, NW.
9 o (Lower Level), Washington, DC 20555-0001. FOR FURTHER INFORMATION CONTACT: C. James Holloway, Jr., Office of the Controller, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Telephone 301-415-6213. SUPPLEMENTARY INFORMATION: I. Background. II. Rerponses to Comments. ~ III. Final Action. IV. Section-by-Section Analysis. V. Environmental Impact: Categorical Exclusion. VI. Paperwork Reduction Act Statement. VII. Regulatory Analysib. 4 VIII. Regulatory Flexibility Analysis. IX. Backfit Analysis. I. Background Public Law 101-508, the Omnibus Budget Reconciliation Act of 1990 (OBRA- 90) , enacted November 5, 1990, requires that the NRC recover approximately 100 percent of its budget authority, less the amount appropriated f rom the Department of Energy (DOE) administered NWF, for FYs 1991 through 1995 by assessing fees. OBRA-90 was amended in 1993 to extend the NRC's 100 percent fee recovery requirement through FY 1998. 2
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The NRC assesses'two types._of fees-to recover its budget authority.__ First, license and inspection fees,! established-in ! 10 CFR<Part 170 under the authority of the Independent' Offices Appropriation Act - (IOAA) , 31 U.S.C. 9701, recover the NRC's1 costs of providing individually identifiable services to' specific applicants and licensees. Examples of the services provided by-the NRC-for which--these fees are assessed are the review of , applications.for the issuance of new-licenses, approvals or renewals, and amendments to licenses or approvals. Second, annual fees, established in 10 CPR Part-171 under the authority of OBRA-90, recover generic and other regulatory costs not recovered through 10 CFR Part 170 fees. 4 On June 20, 1995 (60-FR 32218), the NRC publiched its final
. rule' establishing the licensing, inspection,.and annual fees necessary for the NRC to recover approximately 100 percent of its
-budget authority for--FY 1995, less the appropriation received from the Nuclear Waste Fund. The NRC stated in the FY 1995 final rule that.in an effort-to stabil12e annual fees, begirt..ing in FY 1956, the NRC would adjust the annual fees by_the percentage 1
change (plus or minus) in NRC's total budget authority unless , there was a substantial change in the total lNRC budget authority or.the magnitude of the budget: allocated to a specific class of i licensees,-in which: case the annual fee base would be recalculated (60 FR 32225;-June 20,-1995). The-NRC also stated that the percentage change would be' adjusted based on changes in K
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O the 10 CFR Part 170 fees and other receipts as well as on the number of licensees paying fees. On January 30, 1996 (61 FR 2948), the NRC published a proposed rule to establish the licensing, inspection, and annual fees necessary for the NRC to recover approximately 100 percent of its budget authority for FY 1996,-less the appropriation received from the Nuclear Waste Fund. Several changes were
. proposed by the NRC to the fees to be assessed for FY 1996.
These changes were highlighted in the proposed rule (61 FR 2948; January 30,.1996). The major changes are summarized as follows:
- 1. Stabilize 10 CFR Part 171 annual fees by adjusting all annual fees downward by about 6 percent. This change is consistent with the NRC's intention, stated in the FY 1995 final rule, that annual fees would be' stabilized, beginning in FY 1996, by adjusting the FY 1995 annual fees by the percent change (plus or minus) in the NRC budget authority taking into consideration the estimated collections from 10 CFR Part 170 fees and the number of licensees paying feear
- 2. Assess 10 CFR Part 171 annual fees of less than
$100,000 to materials licensees on the anniversary date of-the license. This change continues the streamlining of fees and allows the NRC to make the billing process more efficient by 4
Q I distributing the billing and collection of annual fees over the entire year. The current practice is to bill over 6,000 l 1 naterials licensees at the same time during the fiscal year; ;
- 3. Eliminate the materials " flat" renewal fees in 10 CFR 170.31 and include the costs of the renewals in the annual fees in 10 CFR 171.16(d) for the affected licensees. This change continues the simplification of fees initiated in FY 1995 and is consistent with NRC's recent Business Process Reengineering initiatives to extend the duration of certain materials licenses (61 FR 1109; January 16, 1996);
- 4. Revise the two professional hourly rates in 10 CFR 170.20 which are used to determine the Part 170 fees assessed by the NRC. The rate for FY 1996 for the reactor program is $128 per hour and the rate for the materials program is $120 per hour; and
- 5. Adjust the 10 CFR 170.21 and 170.31 licensing (application and amendment) " flat" fees for materials licenses to reflect the costs of providing the licensing services.
II. Responses to Comments The NRC received eight comments on the proposed rule. Although the comment period ended on February P.9, 1996, the NRC 5
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~ has reviewed and evaluated all coments received, including hose I a
that;were late.- Many of the coments were similar in nature. For evaldation
.purposesj these coments have been grouped, 'as appropriate, and addressed as single issues in this final rule. The coments are as-followst ,
A,. Cnements reaardina the maior chances croposed in the FY 1996 faa rule,
- 1. Strammline and stabiliza annual f ans, coment . All comenters responding to this proposed change t
were encouraged by and supported the positive steps taken by NRC to equitably distribute and to reduce the burden of user fees on licensees. Several comencers indicated that this change represents a greater simplification and streamlining of the fee setting procedures and has eliminated the dramatic swings in NRC
-fees seen in the past. Comenters stated that the approximate 6 percent reduction in annual fees for all licensees is evidence of this.- Other commenters stated that the-NRC should continue the J
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- process of streamlining and commensurate fee reduction because it is a responsible-approach in light of today's highly competitive ,
global nuclear marketplace. 6 ,
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Response. Consistent with the comments, the final rule adopts the methodology to streamline and stabilize FY 1996 annual fees by adjusting these fees by the percentage change (plus or minus) in NRC's total budget authority. The FY 1995 annual fees have been used as base annual fees and these annual fees have been adjusted downward for FY 1996 based on the percentage change in the NRC's budget authority, taking into consideration the total number of licensees paying fees and estinated collections from 10 CFR Part 170 licensing and inspection fees. Therefore for FY 1996, all annual fees have been adjusted 6.5 percent below the FY 1995 levels.
- 2. Assess annual fees of less than $100,000 to materials licenses on the anniversary date of license.
Comment. Commenters supported the NRC's proposal to invoice materials annual fees of less than $100,000 on the anniversary date of the license. Commenters stated that, while helping to assist NRC in its billing efforts, it will also provide some relief to entities who have several licenses. The proposed system will allow these licensees to distribute their cash outlays over a longer period of time easing the financial stresses caused by a single payment period. Resnonse. Consistent with the comments, the NRC in this final rule will assess 5171.16 (d) annual fees for those materiale 7
c licenses whose annual fees are less than $100,000 based on the anniversary of the date the license was originally-issued. t Accordingly, a new paragraph is-added to 1171.19. For FY 1996, those affected materials licenses with a license anniversary date between O<:tober 1, 1995, and the effective date of this final-FY 1996 fee-tule vill be billed unon publication of the final rule in the Fedtral Register and annually thereafter during the anniversary month of the license. Those affected materials , licenses whose license anniversary date is on or after the effective dLte of this final FY 1996 fee rule will be billed during the anniversary month of the license and annually thereafter based on the annual fee in effect at the time of billing. The specific license categories of materials licensees affected by this change are listed in $171.19(d) of this final rule.
- 3. Revise the two orofessional rates in 10 CFR 170.*z0 based on the FY 1996 budoet and adiust the 10 CFR 170.21 and 170.31 9
licensina (anolication and amendment) " flat" fees for licenmes to reflect the costs of nrovidina the licensine services. Comment. Commenters supported the revised method of calculating two hourly rates adopted by NRC in FL 1995 to separately,: and more equitably, allocate costs associated with the reactor program and the materials program. Commenters stated that the two rates, based on cost center concepts that identify l 0 l l
,D and allocate budgeted resources, is inherently fairer and more equitable to licensees and is more consistent with-Congressional intent to identify'and properly assess fees to.those entities that utilize NRC resources and regulatory services. However, some commenters indicated that, while they are pleased that the materials rate increase is under 4 percent ($116 per hour to $120 per hour) and generally in keeping with inflation, the rate itself is unjustifiably high. These commenters stated that the
$120 hourly rate equals or exceeds the hourly rate of senior consultants or principals at major (national) consulting companies and that it exceeds the accepted rate for similar work in private industry. Some commenters pointed out the increase in the hourly rates exceeds the general increase that was provided to all Federal government workers on January 1, 1996, and they encourage the NRC to control its costs by seeking efficiencies in order to attain a downward trend of licensing and inspection fees comparable to that being realized in the annual fees. 'Other commenters indicated that the average ecst per staff hour assumes a lower number of work hours relative to.that commonly applied in industry and a multiplier which would appear to significantly exceed those commonly enjoyed by private industry. Some commenters stated that although summary calculations are presented in the proposed revisions, insufficient detail is j
provided to determine the justification for an increase in the hourly fees, i.e., the NRC has not listed the assumptions used in forecasting the predicted FTEs (full time equivalents) considered l 9
necessary;for the materials program. Response. Consistent with the comments,-the NRC has l established in this final rule two professional hourly rates for FY 1996 which will be used to determine the 10 CFR Part 170 fees. A rate of $128 per hour is established in 5170.20 for the reactor program and a second rate of $120 per hour is established in -$170.20 for the nuclear materials and nuclear waste programs. The two rates are based on the " cost center" concept that is now being used for budgeting purposes. The NRC professional hourly rates are established to incover approximately 100 percent of the agency's Congressionally-approved budget, less the appropriation from the Nuclear Waste Fund (NWF) , as required by OBRA-90. The rates reflect the NRC budgeted cost per direct professional hour. This cost includes the salary and benefits for .e direct hours, and a prorata share of the salary and benefits for the program and agency overhead and agency general and administrative expenses (e.g., rent, supplies, and information technology). Both the method and budgeted costs used by the NRC in the development of the hourly rates 7f $128 and $120 are discussed in detail in Part III, Section-by-Section Analysis, relating to S170.20 of the proposed rule (61 I7t 2951; January 30, 1996) and the same section of this final rule. For examples Table II shows the budgeted costs and the direct FTEs that must be recovered through fees assessed for 10
the hours expended by-the direct FTEs. The budgeted costs as well as the direct resources are those required by the NRC to implement-its statutory responsibilities and effectively accomplish the mission of the agency. Additional information on the bourly rates is provided in the NRC workpapers located in the Public Document Room. The specific details regarding the budget for FY 1996 are documented in the NRC's publication " Budget Estimates, Fiscal Years 1996-1997" (NUREG-1100, Volume 11), which is available to the public. Copies of NUREG-1100, Volume 11, may
- be purchased from the Superintendent of Documents, U.S.
Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328. Copies are also available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161. A copy is also available for inspection and copying for a fee in the NRC Publ'.c Document Room, 2120 L Street NW. (Lower Level), Washington, DC 20555-0001. B. Other comments. 2
- 1. Public interest exemntions, s
Comment. Commenters supported NRC's decision to continue to charge annual fees to Federal agencies and to deny their requests for exemption based on "public good" claims. Resnonse. Consistent with the proposed rule and the 11
comments received, the NRC does not intend to grant public good exemptions to Federal agencies.
- 2. Fee lecislation.
comment. Several commenters noted that the NRC had completed its report on fee policy as required by the Energy Policy Act of 1992 and that the NRC had cent a report to Congress with legislative recommendations. The commenters commended NRC's efforts in this regard and stated that they continue to believe that 100 percent fee recovery for NRC, as mandated by OBRA-90, is inequitable and unfair to licensees because licensees are paying for certain costs that are not directly related to and do not benefit them. 1te commenters acknowledged that without legfslative changes to OBRA-90, the central problems with NRC's fees cannot be completely resolved. Commenters strongly I supported more efforts to define a more equitable fee base and recommended that the NRC continue to work with Congress and the Administration to obtain the necessary legislative changes. In this regard, commenters stated that it is time for NRC to actively pursue a legislative agenda with Congress by drafting i l specific language to modify OBRA-90 or the Atomic Energy Act. , Resoonse. The need for legislation is beyond the scope of this rulemaking proceeding. As indicated in the FY 1995 final L rule (60 FR 32218; June 20, 1995), the NRC will continue to work l 12
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- 3. Reexamine-the issue of fees.
comments Some commenters stated that both ' Congress and the NRC should reexamine the whole issue of fees in the context of the substantial concerns of licensees regarding t'= -i trend of more st&tes entering into the Agreement State program. These commenters refer to the stated intentions of Pennsylvania, Ohio, Nassachusetts, and Oklahoma to become Agreement States. The commenters indicated thct the NRC Nould then lose about 30 percent of the existing license base and fees would significantly incriase unless other budgeting methods are approved or the number of FTEs is reduced in proportion to the reduction in the number of licenses. Commenters from the uranium recovery industry also indicated that,-as the uranium recovery industry continues to shrink in size, the decreasing number of licensees will ultimately be charged increasing annual fees thereby forcing more financial hardships on an already depressed industry. Commenters state that the current system gives preferential treatment to licensees in Agreement States. One commenter suggested that the NRC should enter into reimbursable agreements with the Agreement States before FY 1997, as stated in the FY 1995 final rule. In addition, one commenter believes that NRC should assess the 13
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Environment'a'l Protection Agency (EPA) 'for NRC work such as review ofiregulations promulgated by-EPA relating Lv radienuclide emission standards. i Lesponse. In rl 1995, . the NRC changed the methodology for allocating those budgeted costs (about 10 percent of the NRC budget . authority); that = cause f airness and equity concerns because ,
.the-legislation requested by the NRC had not been passed by the-Congress (60'FR 32218; June 20, 1995). These costs, which include the cost of the Agreement State oversight and regulatory t
support to the Agreement States, are now treated in a manner similar to overhead. These costs are distributed based on-the percentage of the budget directly attributable to a class of licensees. -Commenters at that time supported this method of allocation as being more equitable, pending legislative relief by Congress to remedy this inequitable situation. If additional states become Agreement States and the NRC decides to rebaseline the fees based on substantive changes to the budget, then any '
-increased cost for Agreement State oversight and regulatory support to the; Agreement States would be identified, treated similar to overhead, and distributed based on the percentage of the budget directly. attributable to a class of licensees.
.The-NRC-also revised its. methodologies in the-FY 1995 final ~
rule for determining annual fees for fuel facility and uranium recovery licensees. The revised methodologies resulted in annual 14 l _ _ . . . ,, . . . . , . . . .
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l fees that more accurately reflect the costs of providing
- regulatory services . to the subclasses of fuel f acility and i uranium recovery licensees. The revised methodologies were fully explainec in Section IV, Section-by-Section Analysis, of the.
final FY 1995 rule (60 FR 32218; June 20, 1995). In response to comments relative to annual fee increases as a result of the decrease in the number of licensees, the changes adopted in the FY 1995 final rule to stabilize fees should minimize large fee changes as a result of decreases in licensees. This is substantiated by this final FY 1996 rule which reduces all annual fees by the percent change to the FY 1995 levels. The NRC indicated in the FY 1995 proposed rule (60 FR 14672; March 20, 1995) that it planned to increase the use of reimbursable agreements with Agreement States and Federal agencies beginning in FY 1997. '*o this end, the NRC has begun this process for Federal agencies. For exanple, in FY 1995 the NRC entered into reimbursable agreements with the National Aeronautics and Space Administration (NASA) for the Cassini mission and the Department of Energy (DOE) for plutonium disposition. Reimbursable agreements with Agreement States, however, continue to generate strong responses, both positive and negative, on-the part of licensees and Agreement States. With respect to the interaction between the NRC and EPA on 15-
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the. promulgation of-regulations, NRC interactions with EPA are an integralapart of NRC's responsibilities under the Atomic Energy-L Act '. Therefore, NRC must include the costs of this work'in its budget and cannot perform such work under reimbursable agreements. In' addition, the Independent Offices Appropriation Act of 1952, as. amended, precludes the NRC from charging fees to Federal agencies for specific services rendered. While the NRC can assess annual' fees to Federal agencies holding ITRC licenses, the EPA is not considered a licensee of the NRC with respect to regulations promulgated by EPA relating to radionuclide emission standards.
- 4. Eges based on other factors.
Comment. One commenter indicated that NRC fees should take into consideration the competitive condition of certain markets and the effect - of fees on domestic ar.d foreign competition. For example, the commenter-suggested that the NRC assess a small fee, such-as $5.00 per pound, on-imported uranium to help offset the NRC budget and that OBRA+90 be amended to include this provision.
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In addition, the commenter suggested that a fee be added to foreign Separative Work Units (SWUs) used by U.S. utilities to enrich uranium.- The commenter-indicated that these fees, if levied, would not only solve part of-the NRC's financing-problems,'but would also " rejuvenate the domestic uranium mining, e . milling, and enrichment businesses." Another commenter believes-16-
that NRC should give full consideration to the effects of imposing significant~ annual fees on the domestic uranium recovery industry particularly in light of the Secrete.ry of Energy's determination that the industry is non-viable and the requirement of the Atomic Energy Act that the country maintain a viable domestic source material industry to sustain vital national interests. 4 Resoonse. OBRA-90 requires that the fees assessed to licensees have a reasonable relationship, to the maximum extent practicable, to the cost of providing the service. The IOAA requires that licensing fees be based on the cost of the services rendered. Consistent with these requirements, the NRC assesses licensing fees for import licenses. Basing flees on market competitive poritions or assessing a $5,00 per pound surcharge on imported uranium would not be consistent with these statutes. The issue of adverse economic impact of fees on NRC licensees was addressed in the FY 1991 final rule published July 10, 1991 (56 FR 31476). The NRC indicated that there will be adverse impacts from implementing the legislation and to eliminate the adverse effects, the annual fees would have to be eliminated or reduced. s The issues of basing fees on market' competitive positions, the amount of material possessed, the frequency of use of the material, and the size of the facilities, were also addressed by
-the NRC in previous rules and in the Regulatory Flexibility Analysis in Appendix A to the final ruls. published July 10, 1991 17
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- J (56;FR 31511-31513). The-NRCLdid not adopt that approach becauwe , ]
it-would require licensees to submit large-amounts!of_new data- -
- and would< require _ additional.NRC staff to evaluate the. data
' submitted r.nd to develop and administer.even more complex fee schedules. The 14RC continues to believu that uniformly allocating the generic and-other regulatory costs to the specific licensee within a class to determine the amount of the annual fee
- is a fair, equitable, and practical _way to recover those costs-and_that establishing reduced annual fees' based on gross receipts
, (size) is the most appropriate approach to minimize the impact'on small entitf.es.- Therefore, the NRC finds no basis for altering its_ approach at this time. This approach was upheld by the D.C.
Circuit in its March 16, 1993 decision in Allied-Sienal.
- 5. Commant. Several cosments were received from uranium
, recovery licensees suggesting: (1) a tiered fee system that would result in full fees for operating facilities and reduced fees for facilities-in shutdown or standby status; (2) a licensee. review board be established to review NRC fees annually; (3) the NRC establish standards for its activities, such as a schedule for
- . response intervals for processing licensing actions; and-(4) 10 CFR Part 170 bills-for' services rendered be itemized to show-hours spent, a description of the work performed, the names of individuals who. completed
- the work and the dates the work was .
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-N-Response.y -In; response to a petitionLof rulemaking from the J
'American! Mining Congress-(now the National Mining Association)
-the-NRC addressed each of these commentsLin the Federal Register on. April 28, 1995 (60 PR'20918L20922).- For'the reasons provided i
in response to the petition, the NRC is not adopting _the suggestions from the commenters-in this final rule. While denying the petition, the NRC noted that it would-continue _its current practice 1of-providing available backup data to support 10-CFR Part 170 licensing and inspection billings upon request by the licensee or applicant, j 6 .. Relationshin-between fees and reaulatory services. Comment. Several commenters indicated that although they appreciate NRC's efforts to stabilize fees, they have concerns about the lack of a reasonable relationship between the cost to uranium recovery licensees of NRC:'s regulatory program and the benefit ' derived from such services. The commenters assert 1that I the Commission cannot impose fees under the IOAA unless there is a rational relationship between the fees and the regulatory services provided.- The commenters, citing'Cantral &S. Motor Freicht Tariff Ass'n v. United-States, 777 F.2d 722, 729 (D.C. Cir. 1985), note that in applying'this IOAA requirement, the fees
' assessed must be reasonably related to, and may not exceed the value of the. service to the recipient whatever the agency's cost-may be. The_commenters then suggest_that the NRC fee system may 3 19
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uviolate_this pr'.nciple because the proposed hourly rate of $120 _ for services-provided by agency professionals is unduly high. , Response. The Commission believes that its IOAA fee schedule is_ fully supported by applicable legal precedent and-r does not adopt commenters' suggestion. In upholding the Commission's IOAA fee schedule, the United States Court-of : Appeals for the Fifth Circuit held that the NRC may recover the full cost of providing_a service to an identifiable recipient. (Emphasis in original) Mississinoi Power & Licht v. NRC, 601 F.2d at 230. This is consistent with the earlier teaching of National Cable Television Ass'n Inc. v. FCC, 554 F.2d 1094, 1106 (D.C. l 1976) relied upon by the court in Central & S Motor Freicht l ! Tariff Ass'a, gup.ra. There the court held that fees should be a reasonable approximation of the attributable costs which the Commission identifies as being expended to benefit the recipient. The Court-suggested that a fee might be questionable if the fee unreasonably- exceeds- the value of- the specific services for which it is charged. Here the services provided by the-NRC are required for licensees to maintain their licenses and the benefits derived therefrom. The basis for the revised hourly rates ils fully discussed in NRC's-response to comment A.3. which relate to the hourly' rates being assessed by NRC under 10 CFR Part 170. The commenters*have provided virtually no evidence that could cause the NRC to conclude thatLits fees unreasonably
. exceed'the value of the services rendered.
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- 7. Comnatitive bids by contractors.
Comment. Two commenters indicated that to control costs government agencies routinely require competitive bids for contract-labor. The commenters stated that costs incurred by the Oak Ridge National Laboratory (ORNL) are considered by many licensees to be excessive, yet 10tc awards contracts to ORNL on an apparently sole source basis. The commenters suggest that NRC consider as large a pool rus possible for potential contractors including both government laboratories and private consultants when seeking contract labor. Response. The NRC is committed to making its regulatory programs more efficient and effective wherever it can do so without diminishing its ability to protect the public health and safety. The NRC follows accepted contracting practices in all contract awards. Before determining whether to place work with a commercial source under the competitive proposal process or with a DOE laboratory, the NRC considers' the type of work to be done, the expertise required, and the past performance of the contractor. If the NRC determines that commercial sources are appropriate to-perform the work and that conflict of interest can be avoided, a competitive procurement may be initiated. Otherw';.. = DOP laboratory may be selected to perform the work. Costs are routinely considered and negotiated in either case. 21 .
1 2 Costs for particular actions are also affected by_the j
. quality of the licensee. submittal, the timeliness-and quality of licensees responses t0 NRC questions, delays caused-by external factors, the complexity of the site, and the degree of cooperation by the licensee with NRC.
- 8. Reaulatory deficiencies.
Comment. Two commenters indicated that the proposed rule ) has no provision for allowing licensees to object to unreasonable costs. The commenters stated that without such a mechanism, licensees are at the mercy of the regulators and are expected to pay for services billed and that there is no assurance that any given regulatory function performed by the NRC will be completed expeditiously, efficiently, or within a reasonable range o2 cost. Response. While the NRC is committed to the expeditious review of each application and uses all reasonable means of a keeping costs as low as feasible, its responsibility for ensuring the public health and safety and environmental protection cannot be compromised. The NRC is committed to the effective use of its increasingly limited resources and therefore-cannot afford to use these resources unwisely if it is to successfully perform its mission. 10 CFR Part.170.51 of the Commission's regulations provides the' mechanism whereby licensees are allowed to dispute a l debt if they believe the debt is incorrect, Disputed debts must l t 22 l
be submitted in'accordance with the provisions of 10 CFR Part
-15.31 " Disputed Debts."
- 9. Fee deferral ooliev for stendard clant and early site reviews.
Comment. One commenter urged the NRC to reestablish the NRC's previous fee deferral policy for standard plant and early site reviews in order to encourage the development of standardized designs and in light of the NRC decision to issue designs to be certified through rulemaking rather than by granting a license for the certified design. Resoonag. The NRC addressed this issue in the FY 1995 final rule (60 FR 32222; June 20, 1995), indicating that the Commission vecided in its FY 1991 final fee rule that the costs for standardized reactor design reviews, whether for domestic or foreign applicants, should be assessed under 10 CFR Part 170 to those filing lan application with the NRC for approval or certification of a standardized design (56 FR 31478; July 10, 1991). The Coundssion revisited this issue as part of its review of fee policy required by tha Energy Policy Act of 1992 (EPA-92) and reconfirmed its FY 1991 decision. The NRC continues to believe that the costs of these reviews should be assessed to advanced reactor applicants. The NRC finds no compelling justification for singling out these types of applications for
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special treatment and shifting additional costs to operating power reactors or other NRC licensees, and does not believe the points made by the commenter are sufficient to change current policy.
- 10. Credit for services rendered to NRC by licensees.
Comment. One commenter stated that the company performs services for the NRC which include training of NRC personnel, familiarization visits for NRC staff and contractors, and NRC requested tours for foreign and domestic dignitaries. The commenter believes that recovery of the costs by the licensee from the NRC would be justified and suggested that cost recovery for the licensee be implemented via " credits" against NRC annual fees. Resnonsa. The annual fees assessed by the NRC are those necessary to recover 100 percent of its budget authority. In order to give " credits" to licensees, the NRC would have to adjust the entire annual fee structure for a few licensees who volunteer to assist the NRC from time to time. Other licensees would be required to pick up the lost sums attributable to the credits. The NRC notes that it is solely within the discretion of the licensee to determine whether or not such assistance should be provided to the NRC. Therefore, the NRC is not adopting this suggestion. 24 ; l
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l i i
- 11. Billina of the Of fice of Nuclear Reaulatorv _Research activities related to denian certification reviews. I comment. One commenter stated that hAC should bill design certification \pplicants for tha Office of Nuclear Reactor ,
Regulation (NRR) activities only and not bill for any activities relating to the Office of Nuclear Regulatory Research (RES), i Response. This issue was addressed in the final FY 1995 fee rule. After careful consideration of the comments received on the proposed rule, the NRC indicated that beginning with the ef fective date of the FY 1995 final fee rule the NRC would bill applicants for RES's direct review and evaluation of the standard design in support of the NRC's Final Design Approval (FDA) design certification (60 FR 14673; March 20, 1995). In the final FY 1995 fee rule, the NRC stated that it was changing its fee policy in this area and that it will charge vendors for only the researen which is necessary to support the issuance of the FDA or certification. Research initiated to address generic issues, such as human factors or code development, will be included in the annual fee assessed under 10 CFR Part 171 annual fees (60 FR 32224; June 20, 1995). The NRC does not believe the arguments advanced by the commenter are sufficient to warrant a change _in i agency policy. 25
.- -- - , _ _ - , - - . . , , , _ . . ~ . , - _ ,
III. Final Action The NRC is amending its licensing, inspection, and annual fees to recover approximately 100 percent of its FF 1996 budget authority, including the budget authority for its Office of the Inspector General, less the appropriations received from the NWF. For FY 1996, the NRC's budget authority is $473.3 million, of which $11.0 million has been appropriated from the NWF. Therefore, OBRA-90 requires that the NRC collect approximately
$462.3 million in FY 1996 through 10 CFR Part 170 licensing and inspestion fees and 10 CFR Part 171 annual fees. This amount to be recovered for FY 1996 is about $41.3 million less than the total amount to be recovered for FY 1995 and $50.7 million less when compared to the amount to bt tecovered for FY 1994. The NRC estimates that approximately $120.5 million will be recovered in FY 1996 from '.ees assessed under 10 CFR Part 170 and other offsetting receipts. The remaining $341.8 million will be recovered through the 10 CFR Part 171 annual feen established for FY 1996.
As a result of the reduced amount to be recovered ftr FY 1996 and the final changes outlined in this section, the FY 1996 annual fees for all licensees have been reduced by 6.5 percent compared to the annual tees assessed for FY 1995. The following exanples illustrate changes in annual fees. 26 ,
- - . .-. .. - . . .- - . - - = . - - - . - - _ . - . _ - - - -
o ! FY 1995 FY 1996 h s of Licensees Annual Fee Annual Fgg ! Power Reactors $2,936,000 $7,746,000 t , Nonpower Reactors 56,500 52,800 High Enriched Uranium Fuel 2,569,000 2,403,000 i Facility : Low Enriched Uranium Fuel 1,261,000 1,179,000 Facility i UF, Conversion Facility 639,200 597,800 Uranium Mills 60,900 57,000 Tvnical Materials Licannees Radiographers 13,900 13,000 Well Loggers 8,100 7,500 Gauge Users 1,700 1,600 Broad Scope Medical 23,200 21,700 The NRC is also continuing its streamlining of the fee structure and process for materials licenses which began in FY 1995 and will make other changes as discussed in Sections A and B. Among the changed will be a change in the billing date for the annual fees imposed on many materials licensues. The NRC's fees for FY 1996 will become effective 60 days after publication of the final rule in the Federal Register. The NRC will send a bill for the amount of the annual fee upon publication of the FY 1996 final rule to the licensee or certificate, registration or approval holder not subject to quarterly billing (those licensees who pay annual fees of less 27 ,
than $100,000) and whose anniversary date (the first day of the raonth in which the original license was issued) is before the ef fective date of the final FY 1996 rule. For these licensees, payment will be due on the ef fective date of the FY 1996 rule. Those materials licensees whose license anniversary date during FY 1996 falls after the effective date of the final FY 1996 rule will be billed during the anniversary month of the license and ptyment will be due on the date of the invoice. A. Amendments to 10 CFR Part 170 Fees for Facilities. Materials, Imnort and Ernort Licenses, and Other Reculatory Servicgg. Four amendments have been made to 10 CFR Part 170. These amendments do not change the underlying basis for the regulation
-- that fees be assessed to applicants, persons, and licensees for specific identifiable services rendered. The amendments also comply with the guidance in the Conference Committee Report on OERA-90 that fees assessed under the Independent Offices Appropriation Act (IOAA) recover the full cost to the NRC of identifiable regulatory services each applicant or licensee receives.
l l First, the two professional hourly rates established in FY 1995 in 5170.20 are revised based on the FY 1996 budget. These l l rates are based on the FY 1996 direct FTEs and that portion of i 28
. l the FY 1996 budget that either does not constitute direct program !
support (contractual ' services costs) or is not recovered through ! the appropriation from the NWF. These rates are used to { determine the Part 170 fees. The NRC has-established a rate of
$128 per hour ($223,314 per direct FTE) for the reactor program. l l
This rate is applicable to all activities whose fees are based on' i full cost under 5170.21 of the fee regulations. A second. rate of. - 9 $120 per hour ($209,057 per direct FTE) is established for the nuclear materials and nuclear waste program. This rate is !
- applicable to all materials activities whose fees are based on full cost under 5170.31 of the fee regulations.
The two rates are based on cost center concepts adopted in FY 1995 (60 FR 32225; June 20, 1995) and used for NRC budgeting i purposes. In implementing cost center concepts, all budgeted i . resources are assigned to cost centers to the extent they can be : separately distinguished. These costs include all salaries and benefits, contract support, and travel that support each cost c center activity. 4 Second, the NRC has adjusted the current Part 170 licensing i and inspection foes in 55170.21 and 170.31 for' applicants and 4 licensees to reflect the changes-in-the revised hourly rates. Third, to con enue FY 1995 initiatives . for-- streamlining its fee program and improving the predictability of does, the NRC has ! 29 1 i
- v. -hy. .r., . . - ,e _ , , . , , . . . ,,,,,_.,,,<..yw v., , - . , _ _ , . ., ,,-.,m.-...e ,..-.,%.y ,-,.,m,,,,y. . . - , , _ , , . . - . - - - ~ , . , , - . . . -v
I eliminated certain materials " flat" renewal fees in 5170.31 and has amended 5170.12 accordingly. This final action is also consistent with NRC's recent Business Process Reengineering initiative to extend the duration of certain materials licences. The NRC published a proposed rule in the Federal Register for comment on September 8, 1995 (60 FR 46784) explaining this initiative. In the September 8, 1995, proposed rule, certain materials licenses would be extended for five years beyond their expiration date. Additionally, comments were requested on the general topic of the appropriate duration of licenses. A final rule was published in the Federal Register on January 16, 1996 (61 FR 1109). The elimination of 10 CFR Part 170 materials " flat" renewal fees continues to recognize that the NRC's " regulatory service" provided to licensees, as referred to in OBRA-90, is comprised of the total regulatory activities that the NRC determines are needed to regulate a class of licensees. These regulatory activities include not only renewals but also inspections, research, rulemaking, orders, enforcement actions, responses to allegations, incident investigations, and other activities necessary to regulate classes of licensees. This final action does-not result in any net fee increases for affected licensees and would provide those licensees with greater fee predictability, a frequent licensee request in comments on past fee rules. The materials annual fees, which include the cost for 30
4 4 may renewals, are effective for FY 1996. Isterials licensees who paid a " flat" 10 CFR Part 170 renewal fee for renewal , applications filed in FY 1996 vill receivo a refund for those payments, as appropriate. Fourth, the language in $170.31, Category 15, relating to export and import licenses, is amended to clarify that export and
~
import of naterials includes the export and import of radioactive waste. The NRC amended 10 CFR Part 110 effective August 21, 1995 (60 FR 37556; July 21, 1995), to require specific licenses for the export or import of radioactive waste. In summary, the NRC has (1) revised the two 10 CFR Part 170 hourly rates; (2) revised the licensing fees assessed under 10 CFR Part 170 to reflect the cost to the agency of providing the services (3) eliminated the materials 'flata renewal fees in S170.31 and amended 5170.12 accordingly; ar.d (4) amended Category 15 in 5170.31 to make clear that fees will be assessed for
-licenses authorizing the export or import of radioactive waste.
B. Amendments to 10 CFR Part 171; Annual Fees for Reactor s Ooeratina Licenses, and Puel Ovele Licenses and Materials i Licenses. Includina Holders of Certificates of Comoliance, Reaistrations, and Quality Assurance Proaram Approvals and Government Acencies Licensed by NRC. 31
Three amendments have been made to 10 CFR Part 171. First, the NRC is amending 55171.15 and 171.16 to revise the annual fees for FY 1996 to recover approxinately 100 percent of the FY 1996 budget authority, less fees collected under 10 CFR Part 170 and funds appropriated from the NWF. t In the FY 1995 final rule, the NRC stated that it would stabilize annual fees as follows. Beginning in FY 1996, the NRC would adjust the annual fees only by the percentage change (plus or minus) in NRC's total budget authority unless there was a substantial change in the total. NRC budget authority or the magnitude of the budget allocated to a specific class of l licensees. If either case occurred, the annual fee base would be recalculated (60 FR 32225; June 20, 1995). The NRC also indicated that the percentage change would be adjusted based on changes in the 10 CFR Part 170 fees and other receipts as well as on the number of licensees paying the fees. The NRC does not believe the changes to the FY 1996 budget compared to the FY 1995 budget warrant establishing new baseline fees for FY 1996. Therefore, the NRC is establishing the FY 1996 annual fees for all licensees at a level of 6.5 percent below the FY 1995 annual fees. The 6.5 percent reduction is based on the changes in the budget to be recovered from fees, the amount of the budget recovered for 10 CFR Part 170 fees and other offsetting receipes, and changes in the number of licensees paying annual fees. Table I shows the total budget and fee amounts for FY 1995 and FY 1996. 32
TABLE I ; calculation of the Percentaae Chance to the FY 1995 Annum 1 Fees (Dollars in Millions) - FY95 FY96_. . Total Budget $525.6 $473.3 Less NWF -22.0 -11.0 Total Fee Base $503.6 $462.3 Less Part 170 Fees and Other Receipts 141.1 120.5 Total Annual Fee Amount $362.5 $341.8 I As shown in Table I, the total amount to be recovered from annual fees in FY 1996 is $20.7M ($341.8-$362.5) or 5.7 percent less than the amount that was to be recovered from annual fees in FY 1995. This difference is the net change resulting from a reduction in the budget and a reduction in the expected collection from 10 CFR Part 170 fees and other receipts. The NRC notes that the rede::: tion in 10 CFR Part 170 fees for FY 1996 results primarily from the fact that NRC had a one-time collection of five quarters of 10 CFR Part 170 fees in FY 1995 as a result of changes in its billing practices which pemits the NRC to bill for services shortly after they are rendered. In addition to changes in the budget and 10 CFR Part 170 33 I i
O e fees and other receipts, the number of licensees to pay fees in FY 1996 changed compared to FY 1995. Also, the amount of the ; small entity surcharge (difference between annual fee and small i entity feel decreased as the annual fees decreased. The changes in the number of licensees in the various classes plus the reduction in the small entity surcharge result in an additional decrease in the annual fee per licensee of 0.8 percent. Thus the total change in the annual fees for FY 1996 compared to FY 1995 is a decrease of 6.5 percent (5.7 percent plus 0.8 percent). Second, Footnote 1 of 10 CFR 171.16(d) is amended to provide for a waiver of annual fees for FY 1996 for those materials licensees, and holders of certificates, registrations, and approvals who either filed for termination of their licenses or approvals or filed for possession only/ storage licenses before October 1, 1995, and permanently ceased licensed activities entirely by September 30, 1995. All other licensees and approval holders who held a license or approval on October 1, 1995, are subject to FY 1996 annual fees. This change is made in recognition of the fact that since the final FY 1995 rule was published in June 1995, some licensees have filed requesto for termination of their licenses or certificates with the NRC. Other licensees have either called or written to the NRC since the FY 1995 final rule became effective requesting further clarificat!on and information concerning the annual fees assessed. The NRC is responding to these requests as quickly as 34 l 1 -_
possible. However, the NRC was unable to respond and take action on all such requests before the end of the fiscal year on September 30, 1995. Similar situations existed after the FY 1991-1994 rules were published, and in those cases, the NRC 1 provided an exemption from the requirement that the annual fee is waived only when a license is terminated before October 1 cf each fiscal year. i Third, beginning in FY 1996, the NRC will assess 5171.16(d) annual fees based on the anniversary of the date the license was originally issued for those materials licenses whose annual fees l l are less than $100,000. Accordingly, a new paragraph is added to { 5171.19. For example, if the original license was issued on June ; 17, then the anniversary date of that materials license, for ! annual fee purposes is June 1. The licensee will be billed in June of each year for the anntal fees in effect on the anniversary date (the first day of the month that the original license was issued) of the license. For FY 1996, those affected materials licenses with a license anniversary date between October 1, 1995, and the effective date of the final FY 1996 fee rule will bc billed upon publication of the final rule in the Federal Register and annually thereafter during the anniversary month of the license. Those affected materials licenses whose license anniversary date is on or after the-effective date of the final FY 1996 fee-rule will be billed during the anniversary month of the license and annually thereafter based on the annual 35
fee in effect at the time of billing. The specific license categories of materials licensees affected by this final change are listed in 5171.19(d) of this final rule. Billing certain materials licensees on the anniversary date of the license will allow the NRC to make the billing process more efficient by distributing the billing and collection of annual fee invoices over the entire year. The current practice is to bill over 6,000 materials licenses simu'.taneously during the fiscal year. Section 171.14 is amended to credit quarterly partial annual fee psyments for FY 1996 already made by certain licensees in FY 3 ,. ..ther toward their tctal annual fee to be assessad, or to make refunds, if necessary. Materials licensees who paid a " flat" 10 CFR Part 170 renewal fee for renewal applications filed in FY 1996 will receive a refund for those payments, as appropriat2. The final amendments to 10 CFR Part 171 do not change the underlying basis for 10 CFR Part 171; that is, charging a class of licensees for NRC costs attributable to that class of licensees. Th3 changes a:e consistent with the NRC's FY 1995 s final rule indicating that, for the period FY 1996-1999, the expectation is that annual fees will be adjusted by the percentage change (plus or minus) to the NRC's budget authority l adjusted for NRC o*fsetting receipts and the number of licensees paying annual fees. 36
.- - - _ . . ~ - - - _ . -
1 h O j IV. Section-by-Section Analysis The following analysis of those sections that will be amended by this final rule provides additional explanatory
~
information. All references are to Title 10, Chapter I, U.S. Code of Federal Regulations. Part 170 Section 170.12 Payment of fees. This section is amended to conform to the streamlining changes being made by the-NRC. Section 170.12(a), which describes application fees, is amended to recognize that the NRC 4 will not issue a new license or amendment prior to receipt of the prescribed fee. Section 170.12 (d) , which describes renewal fees, is amended to recognize that materials " flat" renewal fees are eliminated. Section 170.12(g), which discusses inspection fees, is amended to recognize that materials " flat" inspection fees were eliminated in the FY 1995 final rule (60 PR 32218; June 20, 1995). s Section 170.20 Average cost per professional staff hour. , This section is amended:to establish two professional staff-hour rates based en FY 1996 budgeted costs--one for the reactor 37
, , , ,y-.ev y- ~, ,. ---_ ~ - .-
'e--
- i -, -. -,,-.-.._,,,,,-,,m, e..e,- ,-,-.-.-=,v., , , .
program and one for the nuclear material and nuclear waste program. Accordingly, the NRC reactor direct staff-hour rate for FY 1996 for all activities whose fees are based on full cost under 5170.21 is $128 per hour, or $223,314 per direct FTE. The NRC nuclear naterial and nuclear waste direct staf f-hour rate for all materials activities whose fees are based on full cost under
$170.31 is $170 per hour, or $209,057 per direct FTE. The rates are based on the FY 1996 direct FTEs and NRC budgeted costs that are not recovered through the appropriation Crom the NWF. The NRC has continued the use of cost center concepts established in FY 1995 in allocating certain costs to the reactor and materials programs in order to more closely align budgeted costs with
! specific classes of licensees. The method used to determine the two professional hourly rates is as follows:
- 1. Direct program FTE levels are identified for both the
- r. actor program and the nuclear material and waste program.
- 2. Direct contract support, which is the use of contract or other services in support of the line organization's direct program, is excluded from the calculation of the hourly rate because the costs for direct contract support are charged directly through the various categories of fees.
- 3. All other direct program costs (i.e., Salaries and Benefits, Travel) represent "in-house" costs and are to be
< 38
allocated by dividing them uniformly by the total number of direct FTEs for the program. In addition, salarios and benefits plus contracts for general and administrative support are allocated to each program based on that progrands salaries and benefits. This method results in the following costs which are included in the hourly rates. Table II FY 1996 dudget Authority to be Included in Hourly Rates (Dollars in millions) Reactor Materials Salarv and Benefits Procram Procram Program $149.6 $46.3 Allocated Agency Management & Support 40.9 12.7 Subtotal $190.5 $59.0 General and Administrative Suonort (G LA ). Program Travel and Other Support 11.7 3.2 Allocated Agency Management and Support 69.5 21.5 Subtotal $81.2 $24.7 Less offsetting receipts .1 ----- Total Budget Included in Hourly Rate $271.6 $83.7 Program Direct FTEs 1,216.2 400.5 Rate per Direct FTE $223,314 $209,057 Professional Hourly Rate $128 $120 Dividing the $271.6 nillion budget for the reactor program by the number of reactor program direct FTEs (1216.2) results in a rate for the reactor program of $223,314 per FTE for ,FY 1996. 39
Dividing the $83.7 million budget for the nuclear materials and nuclear waste program by the number of program direct FTEs i (400.5) results in a rate of $S09,057 per FTE for FY 1996. The i l Direct FTR Hourly Rate for the reactor program is $128 per hour (rounded to ths nearest whole dollar). This rate is. cal:ulated , by dividing'the cost per direct FTE ($223,314) by the number of [ productive hours in one year (1744 hours) es indicated in OMB Circu*ar A-76, " Performance of Commercial Activities." The 4 Direct FTX Hourly Rate for the materials program is $120 per' hour [ (rounded to the nearest whole dollar). This rate is calculated by dividing the cost per direct FTE ($209,057) by the number of 5 productive hours in one year (1744 hours). The method used to calculate the FY 1996 hourly rate is the same as the method used i in the FY 1995 rule. The FY 1996 rate is slightly higher than the FY-1995 rate due in part to the Federal pay raise given to > all Federal employees in January 1995. Section 170.21 Schedule of Fees for Production and Utilization Facilities, Review of Standard Reference Design Approvals, Special Projects, Inspections and Import and Expote Licenses, t The NRC is revising the licensing and inspection fees in this section, which are based on full-cost reco'<ery, to reflect FY 1996 budgeted costs and to recover costs incurred by the NRC in providing licensing and inspection services to identifiable recipients. The fees. assessed for services provided under the , 40 l
. i f
schedule are-based on the professional hourly rate, as-ahown in t 5170.20, for the reactor program and any direct program support-l (contractual services) costs expanded by the NRC. Any
- professional hours expended on or after the effective date-of the I
final rule will be assessed at the YY 1996 hourly rate for the- , reactor program, as shown in 5170.20. Although the average f amounts of' time needed to review import and export licensing
- i applications have not changed, the fees in 5170.21, facility !
Category K, have increased from FY 1995 as a result of the 4-
. increase in the hourly rate. j For those applications currently on file and pending completion, footnote 2 of 5170.21 is revised to provide that ;
professional houru expended up to the effective datw of the final , I rule will be assessed at the professional rates in effect at the time the service was rendered. For to91 cal report applications , currently on file that are still pending completion of the t review, and for whit.n review costs have reached the applicable i fee ceiling es'ablished c by the July 2, 1990, rule, the costs incurred af ter any a;pplicable ceiling was reached through August !
- 8, 1991, wi.',1 not be billed to the applicant. Any professional ;
hours expended for the review of topical report applications, I amendments, revisions, or supplements to a topical report on or j af ter August 9,- 1991p are assecsed at the applicable rate 1 established by- 5170.20. 41-
.- ~_--a_-_____~ . ._ _ _... _ .--._ _ _ ._ _ __ _-..__, .
. l l\
Section 170.31 Schedule of Fees for Materials Licenses and Other i Regulatory Services, Including Inspections and Import and Export Licenses, f The licensing and inspection fees in this section, which are ! based on full-cost recovery, are modified to recover the FY 1996 costs incurred by the NRC in providing licensing and inspection services to identifiable recipients. The fees assessed for services provided under the schadule are based on both the professional hourly rate as shown in $170.20 for the materials program and any direct program support (contractual services) costs expended by the NRC. Licensing fees based on the average time to review an application (" flat" fees) are adjusted to reflect the increase in the professional hourly rate fron, v116 per hour in FY 1995 to $120 per hour in FY 1996. The " flat" renewal fees for certain materials licenses in 5170.31 are eliminated and comLined with the materials annual fees in 5171.16(d). The amounts of the licensing " flat" fees were rounded off so that the amounts would be de minimis and the resulting flat fee s would be convenient to the user. Fees that are greater than
$1,000 are rounded to the nearest $100. Fees under $1,000 are rounded to the nearest $10.
Fee Category 15, covering the fees for export and import 42 1 1
licenses, is amended to include clarifying language that export and import of materials includes the export and import of radioactive waste. The NRC amended 10 CFR Part 110 on July 21, i 1995 (60 FR 37556), to require specific licenses for the export and import of radioactive waste. The final rule became effective August 21, 1995. I The licensing " flat" fees are applicable to fee categories 1.C and 1.D; 2.B and 2.C; 3.A through 3.P; 4.B through 9.D, 10.B, 15.A through 15.E and 16. Applications filed on or after the effective date of the final rule are subject to the revised fees in this final rule. Although-the average amounts of time needed f to review licensing applications have not changed, the " flat" 2 fees in 5170.,31 have increased from FY 1995 as a result of the increase in the hourly rate. For those licensing, inspection, and review fees that are based on full-cost recovery (cost for professional staff hours plus any contractual services), the materials program hourly rate of $120, as shown in 5170.20, applies to thore professional staff hours expended on or after the effective date of the final rule. Part 171 Section 171.15 Annual Fee: Reactor Operating Licenses. 43 ,
c The annual fees in this section are revised as described below. Paragraph (d) is removed and reserved and paragraphs (a), (b), (c) (1) , (c) (2) and (e) are revised to comply with the requirement of OBRA-90 that the NRC recover approximately 100 percent of its budget for FY 1996. Paragraph (b) is revised in its entirety to establish the FY 1996 annual fee for operating power reactors and to change fiscal year references from FY 1995 to FY 1996. The fees are established by reducing FY 1995 annual feeJ (prior to rounding) by 6.5 percent. The activities comprising the base FY 1995 annual fee and the FY 1995 r.dditional charge (surcharge) are listed in paragraphs (b) and (c) and contAnue to be shown for convenience purposes. Paragraphs (c) (1) is revised in its entirety and (c) (2) is removed and reserved. With respect to Big Rock Point, a smaller, older reactor, the NRC hereby grantu a partial exemption from the FY 1996 annual fees similar to FY 1995 based on a request filed with the NRC in accordance with 5171.11. s Each operating power resctor, except Big Rock Point, will pay an annual fee of $2,746,000 in FY 1996. Paragraph (d) is removed and reserved. 44
Paragraph (e) is revised to show the amount of the FY 1996 annual fee for nonpower (test and research) reactors. In FY 1996, the annual fee of $52,800 is 6.5 percent below the FY 1995 level. The Energy Policy Act of 1992 established an exemption for certain Federally-owned research reactors that are used primarily for educational training and academic res' arch purposes, where the design of the reactor satist' s certain technical specifications set forth in the legi 4 tion. Consistent with this legislative requirement, thi NRC granted an exemption from annual fees for FY 1992 and FY 1993 to the Veterans Administration Medical Center in Omaha, Nebraska, the U.S. Geological Survey for its reactor in Denver, Colorado, and the Armed Forces Radiobiological Institute in Bethesda, Maryland, for its research reactor. This exemption was initially codified in the July 20, 1993 (58 FR 38695) final fee rule at 5171.11(a) and more recently in the March 17, 1994 (59 FR 12543) finhl rule at 5171.11(a) (2) . The NRC amended 5171.11 (a) (2 ) on July 20, 1994 (59 FR 36895) to exempt from annual fees the research reactor owned by the Rhode Island Atomic Energy Commission. The NRC will continue to grant exemptions from the annual fee to Federally-owned anc State-owned research and test reactors that meet the exemption criteria specified in 5171.11. Section 171.16 Annual feest Materials Licensees Holders of Certificates of Compliance, Holders of Sealed Source and Device Registrations, Holders of Quality Assurance Program Approvals, 45
O
. l and Government agencies licensed by the NRC.
I Section 171.16(c) covers the fees assessed for those ; licensees that can qualify as small entities under NRC sise standards. The NRC will continue to assess two fees for i licensees that qualify as small entities under the NRC's size standards. In general, licensees with gross annual receipts of $350,000 to $5 million pay a maximum fee of $1,800. A second or lower-tier saali entity fee of $400 is in place for small entities with gross annual taceipts of less than $350,000 and small governmental jurisdictiont with a population of less than 20,000. No change in the ams m. of the small entity fees is being made because the small entity fees are not based on the budget but are established at a level to reduce the impact of fees on small entities. The small entity fees are shown in this final rule for convenience. Section 171.16(d) is revised to establish the FY 1996 annual fees for materials licensees, including Government agencies, licensed by the NRC. These fees were determined by reducing the FY 1995 annual fees (prior to rounding) by 6.5 percent. For the first time, the NRC is combining the " flat" material renewal fees in 10 CFR Part 170 with the annual fees in 10 CFR Part 171. As described in the Federal Regitter on September 8, 1995 (60 FR 46784), recent NRC internal reviews and regulatory 46
impact surveys of materials licensees have highlighted areas in which the current materials licensing process can be improved. The NRC has completed the preliminary phases of its Business Process Reengineering (BPR) initiative to redesign the process of licensing medical, academic, and industrial users of byproduct materials as well as with regard to some small scope users of source and special nuclear materials. The NRC has extended, by rulemaking, certain specific materials licenses by five years from the current expiration dates of those licenses. Resources that would have otherwise been used to renew these licenses would be devoted to the BPR project. The NRC is also examining whether to permanently change the license duration for mate'ials r licenses. The NRC estimates that approximately 80 percent of its approximately 6,500 materials licenses will be extended by the final rulemaking published in the Federal Register January 20, 1996 (60 FR 1109). Consistent with this change in license renewals, the NRC is, for fee purposes, combining the naterials
" flat" renewal fees in 10 CFR Part 170 with the annual fees in 10 CFR Part 171.
This action also recognizes that the NRC's " regulatory service" provided to licensees, as referred to in OBRA-90, is comprised of the total regulatory activities that the NRC determines are needed to regulate a class of licensees. These regulatory activities include not only " flat" fee inspections but also research, rulemaking, orders, enforcement actions, responses 47
-to allegations,. incident investigations, and other activities !
necessary to regulate classes of licensees. In addition to being i consistent with the regulatory service concept of OBRA-90, the NRC believes that materials licensees' " flat" renewal fees can be i combined with their annual fees without creating any significant t I questions of fairness. This is beenuse the concept of the annual fee, including the renewal fee, has, in effect, alres'y been implemented for most materials licensees. First, materials licensees currently pay a aflat tee" per renewal based on the ! average cost of a renewal for their fee category,_and second, the renewal term of five years is i?sntical for most materials licensees. Thus, licensees in the same materials license fee , category already pay essentially the same average annuc1 cost for renewals. Further, the average cost will decrease to a 1 i relatively small amount as a result of the five-year extension and potential change in license duration. Therefore, combining renewal and annual fees results in essentially the same average , cost per license over' time. This approach will provide materials licensees with simpler and more predictable NRC fee charges as there will be no additional fees paid for periodic renewals. Because certain materials FY 1996 annual fees will include s renewals, those materials licensees.who paid a " flat" 10 CFR Part l 170 renewal fee for renewal applications filed in FY_1996 will be issued a refund, as appropriate. Beginning in FY 1996, the NRC will also bill annual fees for 48 , i
,'s, . . . . _ . ~ _ _ . , _ - , , _ . . _ - , . - _ - _ _ _ - , _ _ _ . - - _ _ _ _ _ _
_- .-. . - - . - - - - - = - _ - .- - ---
. i most materials licenses on the anniversary date of the license (licensees whose annual fees are $100,000 or more will continue ,
to be assessed quarterly). The annual fee assessed will be the i fee in effect on the license anniversary date. This final rule will-apply to those materials licenses in the following fee i categories: 1.C. and 1.D. ; 2. A. (2 ) through 2.C.; 3.A. through 3.P.s 4.A. through 9.D., and 10.B. Billing most materials licenses on the anniversary date of the license will allow the NRC to improve the efficiency of its billing process; under this final rule an average of-approxinately 500 annual fee invoices will be sent to materials licensees each month. The current practice of billing over 6,000 materials licensees simultaneously each fiscal year is eliminated. For annual fee purposes,- the anniversary date of the materials license is considered to be the first day of the month in which the original materials license was issued. For example, if the original materials license was issued on June 17 then, for annual fee purposes, the anniversary date of the materials license is June 1 and the licensee will be billed in June of each year for the annual fee in effect on June
- 1. This final change to the billing system means that during the transition period of FY 1996 affected materials licensees with an anniversary date falling between October 1, 1995, and the effective date of the FY 1996 fee rule will receive a bill payable on the effective date of the FY 1996 final rule.
Affected materials licensees with license anniversary dates falling on or after the effective date of the FY 1996 final rule 49 . i l
9 will be billed during their anniversary month of their license. i Under this final rule, some materials licensees will unavoidably receive two annual fee bills during the 12 month tzansition l period. For example, a materials licensee who paid its FY 1996 ; annual fee bill in May 1996, the planned effective date of the FY ! 1996 fes rule, will receive a bill six months later in November 1996 (FY 1997) if November is the anniversary month of that materials license.- In this example, the licensee will pay the same annual fee in FY 1997 (November) as he paid in FY 1996 (May). Materials licensees will continue to pay fees at the FY 1996 rate in FY 1997 until such time as the FY 1997 final fee rule becomes effective. Each bill would be for a different i fiscal year, therefore, no double billing would occur. The NRC believes that the efficiencies gained by billing certain materials annual fees throughout the year as well as having materials licensees know exactly when they will be billed each year for the annual fee outweigh the inconveniences that may be caused during the transition period. New licenses issued during FY 1996 will receive a prorated annual fee in accordance with the curront proration provision of 5171.17. For example, j those new materials licenses issued during the period October 1 through March 31 of the FY_will be assessed one-half the annual fee for FY 1996. New materials licenses issued on or after April . i 1, 1996, will not be assessed an annual fee for FY 1996. l Thereafter, the full annual fee is due and payable each 50 l
. r f subsequent fiscal year on the caniversary date of the license. l Beginning with the ef fective- date of this FY 1996 final rule, affected licensees will be billed and will pay the annual fee in ! effect on the anniversary date of the license. Affected ( licensees who are not sure of the anniversary date of their l materials license should check the original issue date of the ! license. A materials licensee may pay a reduced annual fee if the licensee qualifies as a small entity under the NRC's size j standards and certifies that it is a small entity using NRC Form l i 526. The amount or range of.the FY 1996 annual fees for all 4 materials licensees is summarized as follows: Materials Licennes Annual Fee Ranges patamory of Licenna Annual Fees Part 70 - High $2,403,000 enriched fuel facility , Part 70 - Low $1,179,000 ,
' enriched fuel facility Part 40 - UFs $597,800
- conversion facility Part 40 - Uranium $20,600 to $57,000 recovery facilities Part 30 - Byproduct
$450 to $21,700 l' !
Material Licenses 51 ;
l l Part 71 - Transporta- $950 to $72,700 i tion of Radioactive i' Material Part 72 - Independent $260,900 Stc age of Spent Nuclear Fuel l' Excludes the ahnual fee for a few military " master" materials licenses of broad-scope issued to Government agencies, which is ,
$388,400. t Section 171.16(e) is revised in its entirety to indicate the activities that were a part of the additional charge (surcharge) included in the FY 1995 annual fees. These activities are listed ind continue to be shown for convenience.
1 Footnote 1 of 10 CFR 171.16(d) is amended to provide a waiver of the annual fees for materials licensees, and holders of certificates, registrations, and approvals, who either filed for termination of their licenses or approvals or filed for possession only/ storage only licenses before October 1, 1995, and permanently ceased licensed activities entirely by September 30, 1995. All other licensees and approval holders who held a license tr approval on October 1, 1995, are subject to the FY 1996 annual fees. Section 171.7' Payment, l 52
~ .- . . . . , . . - .- - . . . . . - - . - - - . _ . . - _ . - - .
Paragraph (b) is_ revised to give credit _for partial payments made by certain licensees in FY 1996 toward their FY 1996 annual fees. The NRC anticipates that the first, second, and third quarterly payments for FY 1996 will have been made by operating. power reactor licencaes and some large materials licensees before this final rule is effective. Therefore, the NRC will credit payments received for those quarterly annual fee asnessments toward th'e total annual fee to be assessed. The NRC will adjust the fourth quarterly bill to recover the full amount of the revised annual fee or to make refunds, as necessary. The NRC also expects that certain materials licensees will have paid renewal fees for renewal applications that were filed in FY 1996, whereas this final rule includes the renewals in the annual fee. The NRC will refund these renewal fee payments,, as appropriate. Payment of the annual fee is due on the date of the invoice and interest ,ccrues' from the invoice date. However, interest will be waived if payment is received within 30 days from the invoice dat>. Paragraph (c) is revised to update fiscal year references , and to delete the references concerning payment requirements for those licensees whose annual fees are less than $100,000. A new im agraph (d) is added co cover those licensees whose annual fees are less than $100,000 and who will be billed on the anniversary date of their license beginning in FY 1996. 53
- =. . . -. . . - -
During the-past-five yearr many licensees have indicated that, although.they held a valid WRC license authorizing the possession and use of special nuclear, source, or byproduct material, they were either not using the material to conduct operations or had disposed of the material and no longer needed the license. In response, the NRC has consistently stated that annual fees are assessed based on whether a licensee holds a valid NRC license that authorizes possession and use of radioactive material. Whether or not a licensee is actually conducting operations using the material is a matter of licensee discretion. The NRC cannot control whether a licensee elects to possess and use radioactive material once it receives a license from the NRC. Therefore, the NRC reemphasizes that the annual fee will be assessed based on whether a licensee holds a valid NRC license that authorizes possession and use of radioactive 1 material. To remove any uncertainty, the NRC issued minor clarifying amendments to 10 CFR 171.16, footnotes 1 and 7 on July 20, 1993 (58 FR 38700). The NRC reinstated the exemption from 10 CFR Part 171 ann.lal l fees for nonprofit educational institutions on April 18, 1994 (59 FR 12539; March 17, 1994). In that final rule, the NRC indicated that although nonprofit research institutions were not exempt ; l from annual fees, such institutions were free to file an ; 1 exemption request based on the "public good" concept if they felt they could qualify. Several nonprofit research institutions have 54 1
since filed and been granted an exemption from the annual fees on that basis. In addition, some Federal agencies who hold materials licenses have filed for exemption from annual fees based on the public good concept as well. The requests from Federal agencies to receive public good exemptions have been denied by the NRC. The NRC did not intend to extend public good exemptions to Federal agencies. V. Environmental Impact: Categorical Exclusion The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22 (c) (1) . Therefore, naither an environmental impact statement nor an environmental impact assessment has been prepared for the. final j regulation. By its very nature, this regulatory action does not affect the environment, and therefore, no environmental justice issues are raised. VI. Paperwork Reduction Act Statement This final rule contains no information collection s requirements and, therefore, is not subject to the requirements-of the Faperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) . l j VII. Regulatory Analysis 55
~ With respect; to -10 CMt Part 170, this final rule was
- developed pursuantLto Title V of the Independent Offices-Appropriation Act of 19521(IOAA) (31 U.S.C. 9701) and the
- Commission's fee guidelines. When developing these guidelines the Commission took into account guidance provided by the U.S.
Supreme' Court on~ March 4, 1974, in its decision of National Cab 13 Television Association.-Inc. v. United States, 415 U.S. 36 (1974) and Federal Power Commission v. New Enoland Power Comnany, 415 U.S. 345 (1974). In these decisions, the Court held that the-IOAA authorizes an agency to charge fees for special benefits rendered to identifiable persons measured by the "value to the recipient" of the agency service. The meaning of the IOAA was further clarified on December 16, 1976, by four decisions of the U.S. Court.of Appeals for-the District of Columbia: National Czble Television As ociation v. Federal Cnemunications Commiss12D, 554 F.2d 1094 (D.C. Cir. 1976); National Association gi,,Jyondcasters v. Federal Communications commission, 554 F.2d 1118 _(D.C. Cir. 1976); Electronic Industrier Association v. Federal Communications enemimmion, 554 F.2d 1109 (D.C. Cir. 1976) and Caoital cities en=munication. Inc. v. Federal Cnmmunications Commission, 554 F.2d 1135 (D.C. Cir. 1976). These decisions of the Courts enabled the Commission to develop fee guidelines that are.still used for cost recovery and fee development purpoces. The Commission's fee ~ guidelines were upheld on August 24, 1979, by'the U.S. Court-of Appeals for the Fifth Circuit in 56 4
., m --
w - , - -
.. . _ ~ . - . . -_ .-. _. . . _ _ - . -.
Mississinoi Power and Licht Co. v. U.S. Nuclear Reculatorg Commission, 601 F.2d 223 (5th Cir. 1979), cert. denied, 444 U.S. 1102-(1980). The Court held that-- (1) The NRC had the authority to recover the full cost of providing services to identifiable beneficiariesi {2) 12ue NRC could properly assess a fee for the costs of l providing routine inspections necessary to ensure a licensee's compliance with the Atomic Energy Act and with applicable regulations; (3) The NRC could charge for costs incurred in conducting envitonmental reviews required by NEPA; (4) The NRC properly included the costs of uncontested hearings and of administrative and technical support services in the fee schedule; (5) The NRC could assess a fee for renewing a license to operate a low-level radioactive waste burial site; and (6) The NRC's fees were not arbitrary or capricious. With respect to 10 CFR Part 171, on November 5, 1990, the Congress passed Public Law 101-508, the Omnibus Budget 57
1
- Reconciliation Act of 1990 (OBRA-90) which required that for FYs 1991-through 1995,.approximately 100 percent of the NRC budget authority be recovered through the assessment of-fees. OBRA-90 was amended in 1993 to' extend the 100 percent fee recovery requirement'for NRC through-FY.1998. To accomplish this.
Lstatutory' requirement, the NRC, in accordance with $171'.13, is publishing the final amount of the FY 1996 annual-fees for
. operating reactor licensees, fuel' cycle. licensees, materials licensees, and. holders of Certificates of Compliance, registrations of sealed source and devices anu QA program approvals, and Government agencies. OBRA-90 and the Conference Committee Report specifically state that--
4 (1) The annual fees be based on the Commission's FY 1996 budget of $473.3 million less the amounts collected from Part 170 fees and the funds directly appropriated from the NWF to cover the NRC's high level waste program; (2) The annual fees shall, to the maximum extent I practicable, have a reasonable relationship to the cost'of
-regulatory services provided by the Commission; and l
1
-(3)2 The annual fees be assessed to-those licensees the Comission, . in -its . discretion, - determines can f airly, equitably, and practicably contribute to their payment.
4 58 1 1-m += a- _'A ---&19 6 &m<> m m- m W-' ~W vs w, r 9 -nw-r A x- Y- m
10'CPR'Part 171, whd-h est.ablished annual fees fe: operating power reactors effectivt ,ctober 20, 1986 (51 FR 33224; September 18, 1986), was challenged and upheld in its entirety in Florida Power and Licht Comnany v. United States, 846 F.2d 765 (D.C. Cir. 1988), cert. denied, 490 U.S. 1045 (1989). The NRC's FY 1991 annual' fee rule was largely upheld by the D.C. Circuit Court of Appeals in Allied Sional v. NRC, 988 F.2d 146 (D.C. Cir. 1993). VIII. Regulatory Flexibility Analysis The NRC is required by the Omnibus Budget Reconciliation Act of 1990 to recover approximately 100 percent of its budget authority through the assessmant of user fees. OBRA-90 further requires that the NRC establish a schedule of charges that fairly and equitably allocates the aggregate amount of these charges among licensees. This final rule establishes the schedules of fees that are necessary to implement the Congressional mandate for FY 1996. The final rule results in a decrease in the annual fees charged to all licensees, and holders of certificates, registrations, and approvals. The Regulatory Flexibility Analysis, prepared-in accordance with 5 U.S.C. 604, is included as Appendix A to this final rule. l 59 l 1
. l
.IX. Backfit Analysis The NRC has determined that the backfit. rule, 10 CFR 50.109, does not apply to this final' rule and that a backfit analysis;is not required for this final rule. The backfit analysis is not required because these final amendments do not require the modification of or additions to systems, structures, components, >
or the design of a facility.or the design approval or
~
' manufacturing' license for a facility or the procedures or organization required to design, construct or operate a facility.
Lisc of Subjects
-10 CFR Part 170 -- Byproduct material, Import and export licenses, Intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.
10 CFR Part 171 -- Annual charges, Byproduct material, Holders of certificates, registrations, approvals,- Intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and-reactors, Source' material, Special nuclear material. 60
I f 4 For the reasons set out in the preamble and under the'
' authority of the' Atomic Energy Act of 1954, as amended, and 5. ;
U.S.C.-552 and 553, theLNRC is adopting the following amencments to 10 CFR Parts 170 and 171. PART 170 -- FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT ~
-LICENSES, AND OTHER-REGULATORY SERVICES UNDER THE ATOMIC ENERGY _
ACT OF 1954,~AS AMENDED
- 1. -The' authority citation for Part 170 continues to read as follows:
Authority: 31 U.S.C. 9701, 96 Stat. 1051; sec. 301, Pub. L. 92-314, 86 Stat. 222 (42 U.S.C. 2201w) ; sec. 201, Pub. L. 93-4381, 88 Stat. 1242, as amended (42 U.S.C. 5841) ; sec. 205, Pub. L. 161-576, 104 Stat. 2842, (31 U.S.C. 901).
- 2. In Section 170.12, paragraph (d) (1) is removed and reserved and paragraphs (a) and_(g) are revised to read as follows:
E170;12 Payment of fees. (a) Application fees. Each application for which a i fee-is prescribed'shall be accompanied by_a remittance in-the full amount-of the fee. -The NRC will not issue a new license or i 61 l
,- j i
\
l amendment prior to the receipt of the prescribed fee. All
. application fees will be charged irrespective oflthe Commission's- - disposition of the application or a withdrawal of the application.
(d) * ** (1) [ Reserved). (g) Inspection fees. Fees for all inspections subject to full cost recovery will be assessed on;a per inspection basis for completed inspections and are payable, on a quarterly basis, upon notification by the Commission. Inspection costs include preparation time, time on site, and documentation time and any associated contractual service costs, but exclude the time involved in the processing and issuance of a notice of violation or civil penalty, w
- 3. Section 170.20 is revised to read as follows:
E170.20- Averace cost ner orofessional staff-hour. 62-
)
Fees for permits, licenses, amendments, renewals, special projects, Part'55 requalification and replacement examinations ~ anditests, other required-reviews, approvals, and inspections-under SS170.21 and'170.31 that are based upon the full costs for the review ~or inspection will be calculated using the following applicable professional staff-hour-rates:- Reactor Program $128 per hour (5170.21 Activities) Nuclear Materials and Nuclear Waste Program $120 per hour (5170.31 Activities)
- 4. In 5170.21, the introductory text, Category K, and footnotes 1 and 2 to the table are revised to read as follows:
E170.21 Schedule of fees for oroduction and utilization facilities. review of standard referenced desien aporovals, soecial croiects, insoections and import and eroort licenses. Applicants for construction permits, manufacturing licenses, operating licenses, import-and export licenses, approvals of facility standard reference designs, requalification and replacement examinations for reactor operators, and special _ projects and holders of construction permits, licenses, and other 63
l approvals shall pay ~ fees for the following categories of ,
-services.
Schedule of Facility Fees (seeifootnotes at end of table) Facility Categories and Type ~of Fees Fees 1/ 2/ K. Import and export licenses: Licenses for the import and export only of produccion and utilization facilities or the export only of~ components for prcduction and utilization facilities issued pursuant to 10 CFR Part 110.
- 1. Application for import or export of reactors and other facilities and exports of components which must be reviewed by the Commissioners and the Executive Branch, for. example, actions under 10 CFR 110.40(b).
-Application-new license . . . . . $7,800 Amendment . . . . . . . . . . . . $7,800 64 7
i
.1 !
l
.o l
- 2. -Application for export of reactor and other
.. 1 components requiring Executive Branch review only, for example, those. actions under 10-CFR ;
110.41(a) (1) - (8) . Application-new license . . . . . $4,800 Amendment . . . . . . . . . . . . $4,800
- 3. Application for export of components requiring fotsign government assurances only.
Application-new license . . . . . . $3,000 Amendment . . . . . . . . . . . . . $3,000
- 4. Application for export of facility components and equipment not requiring Commissioner review, Executive Branch. review,.or foreign government l
assurances. Application-new-license . . . . . $1,200 Amendment . . . . . . . . . . . . $1,200
- 5. Minor amendment of any export or import license to
-extend the expiration date, change domestic information, or make other revisions which do not require in-depth analy sis or review.
65'
l Amendment . .. . . . . . .. . . . $120 i' Fees will not be charged for orders issued by the Commission - pursuant to 52.202 of this chapter or for amendments resulting
'specifically from the requirements of these types of Commission orders. Fees will be charged for approvals issued under a specific exemption provision of the Commission's regulations under Title 10 of the Code of Federal Regulations (e.g., SS50.12, 73.5) and any other sections now or hereafter in effect regardless of whether the approval is in the form of a license amendment, letter of approval, safety evaluation report, or other form. Fees for licenses in.this schedule that are initially issued for less than full power are based on review through the issuance of a full power license (generally full power is considered 100 percent of the facility's full rated power) .
Thus, if a licensee received a low power license or a temporary license for less than full power and subsequently receives full power authority (by way of license amendment or otherwise), the total costs for the license will be determined through that period when authority is granted for full power operation. If a situation aricas in which the Commission determines that full s operating power for a particular facility should be less than 100 percent of full rated power, the total costs for the license will be at that determined lower operating power level and not at the 100 percent capacity. 66
I I' Full cost fees will be determined based on the professional staff time and appropriate contractual support services expended. For applications currently on file and for which fees are determined based on the full cost expended for the review, the professional staff hours expended for the review of the application up to the effective date of the final rule will be determined at the professional rates in effect at the time the service was provided. For those applications currently on file for which review costs have reached an applicable fee ceiling established by the June 20, 1984, and Ju'y 2,
. 1990, rules but are still pending completion of the review, the cost incurred after
- any applicable ceiling was reached through January 29, 1989, will not be billed to the applicant. Any professional staff-hours expended above those ceilings on or after January 30, 1989, will be assessed at the applicable rates established by 5170.20, as appropriate, except for topical reports whose costs exceed
$50,000. _ Costs which exceed $50,000 for any topical report, amendment, revision or supplement to a topical report completed or undcr review from January 30, 1989, through August 8, 1991, will not be billed to the applicant. Any professional houru expended on or after August 9, 1991, will be assessed at the applicable rate established in 5170.20. In no event will the total review costs be less than twice the hourly rate shown-in 5170.20.
67
- Section 170.31-'is. revised to read as follows:
5.- - r E170 31- -schedule of' fees for materials licenses-and other ~ , reaulatorv' services, includina inmoections, and'imnort and avnort , licenses.- i 1 L Applicants for-materials licenses, import and export , licenses, and other regulatory services and holders of materials- , ' ' licenses, or import and export. licenses-shall pay fees'for the , 4
- . following-categories of services. This schedule includes faes for health and safety and safeguards inspections where applicable. .,
SCHEDULE OF MATERIALS FEES (See footnotes at end of table) Categorv of materials licenses and tvoe of fees 1' Eggl ' l'
- 1. Special nuclear material:
A. Licenses for possession-and use of-200
, 3 rams or more of plutonium in unsealed form or'350 grams or more of. contained U-235.in unsealed form or 200 gratr.s or more of U-233 in'. Unsealed form. This includes applications.to terminate licenses as;well as licenses authorizing
.68 ,
5 possession only: License, Renewal, Amendment . .. .. . Full Cost-Inspections . . . . . -. . . .. .. .-. Full Cost-B. Licenses for receipt and storage of spent
~
fuel at an independent spent fuel storage _. t installation (ISFSI) : P License, Renewal,. Amendment . . . . . . Full Cost Inspections . . . . . . . . . . . . . Full Cost C. Licenses _for. possession and use of special nuclear material in sealed sources contained in devices used in industrial measuring systems, including x-ray fluorescence analyzers :i' Application - New license . . . . . . $550 Amendment'. . . . . . . . . . . . . . $300 i s D. A11'other special nuclear material licenses, except licenses authorizing ~special nuclear material in unsealed form in combination that would constitute a' critical quantity, as-defined-in S 150.11 of this chapter, for which 69 i
l 1 the licensee shall-pay the same fees.as those-for Category 1A:A' i Application - New license . . . . . . $600 Amendment . . . . . . . . . . . . . . $200 E. Licenses for construction and operation of
-a uranium enrichment facility.
Application . . . . . . . . . . . $125,000 License, Renewal, Amendment . . . Full Cost Inspections . . . . . . .. . . . Full Cost
- 2. Source material:
I A. (1) Licenses for possession and use of source
. material in recovery operations such as milling, in-situ leaching, heap-leaching, refining uranium nd11 concentrates to uranium hexafluoride, ore buying stations, ion exchange facilities and in processing of ores containing source material ~for extraction of. metals other than uranium or thorium, including licenses authorizing the possession of byproduct waste material l
.(tailings) from source material recovery l
70 l
operations,.as well as licenses authorizing the possession and maintenance of a facility. in a standby mode: License,-Renewal, Amendment .- . . . Full Cost l Inspections . . . . . . . . . . . . Full Cost (2) Licenses that authorize the receipt of byproduct material, as defined in Section 11e(2) of the Atomic
-Energy Act, from other persons for possession and disposal except those licenues subject to fees in Category 2. A. (1) .
License, renewal, amendment . . . . . Pull Cost Inspections . . . . . . . . . . . . . Full Cost (3) Licenses that authorize the receipt of byproduct-material, as defined in Section 11e(2) of the Atomic Energy Act, from other persons.for posesssion and disposal incidental uo the disposal of the uranium waste tailings generated by the licensee's udlling operations, except those licenses subject to the fees in Category 2. A. (1) . License, renewal, amendment'. . . . . Full Cost Inspections . . . . . . . . . . . . . Full Cost 71 -
. . . . . . - . _ . - . _ - . . - - - . . . - . - - - ~ . . _ . _ . - .
B.- Licenses which--authorize the possession, use and/or installation of source material forl shielding: Applicacion - New license . ... . $160L Amendment . . . . . . . . .- . . . . $240 , C. All other source material licenses: Application'- New license . . . . $2,800 Amendment . . . . , . . . . . . . $420
- 3. Byproduct material:
A. Licenses of broad scope for possession and use of byproduct material issued pursuant to Parts 30 and 33 of this chapter for processing or manufacturing of items containing byproduct material for commercial distribution: Application - New license . . . .. $3,000 Amendment.. . . . . . . . . . -. . . -$550 s B. Other licenses for possession and use of byproduct material issued pursuant - to Part 20 of this chapter- for 4 processing or manufacturing of items containing-byproduct-material for commercial distribution: 72
Application - New-licentte . ... . . . . $1,200-Amendment . . ., . . . . . . .. . $580.. c . _- - Licenses issued pursuant to 5532.72, 32.73, and/or 32.74 of this chapter authorizing-the processing or manufacturing and distribution or redistr1bution of radiopharmaceuticals, generator 2, reagent kits-and/or sources and devices containing byproduct material: Application - New license . . . . . $4,100 Amendment . . . . . . . . . . . . . $520 D. Licenses and approvals issued pursuant to 5532.72, 32.73, and/or 32.74 of this chapter authorizing distribution or redistribution of radiopharmaceuticale, generators, reagent kits and/or sources or devices not involving proccssing of byproduct material: Application - New license-. . . . . $1,500 Amendment . . . . . . . . . . . . . $430 E. Licenses for possessica and use of byproduen material in sealed sources for irradiation of materials in which the source is not removed from-its shield self-shielded unito) : 73 4
Application --New license . . . . . .. $1,200 Amendment . . . . . . . . . . . . . . $360 F. Licenses for possession and use of less than 10,000 curies of byproduct material in sealed sources for irradiation of materials in which the source is exposed for irradiation purposes. This category also includes underwater irradiators for irradiation of materials where the source is not exposed for irradiation purposes. Application - New license . . . . . $1,500 Amendment . . . . . . . . . . . . . $370 G. Licenses for possessfi and use of 10,000 curies or more of byproduct matt al in sealed sources for irradiation of materials in which the source is exposed for irradiation. purposes. This category also includes uderwater irradiators for irradiation of materials where the source is not exposed for irradiation purposes. Application - New license . . . . . $6,000 Amendment . . . . . . . . . . . . . $780 H. Licenses issued _oursuant to Subpart A of Part 32 of 74
.- l l
this-chapter to distribute items containing byproduct material that require device review to persons exempt from the-iicensing requirements of Part'30 of this chapter, except specific licenses authoriziny redistribution of items that have been authorized for j i distributien to persons exempt from the licensing ; requirements of Part 30 of this chapter: Application - New license . . . . . $2,400 Amendment'. . . . . . . . . . . . . $1,000 I. Licenses issued pursuant to Subpart A of Part 32'of this chapter to distribute items containing byproduct material or quantities of byproduct material that do not require device evaluation to persons exempt from the licensing requirements of Part 30 of this chapter, except for specific licenses authorizing redistribution
-of-items that have been authorized for distribution to persons exempt from the licensing requirements of Part 30 of this chapter:
s Application - New license . . . . . $4,400 Amendment .. . . . . . . . . . . . $860 J. Licenses issued pursuant to Subpart B of Part 32 of l this chapter to distribute items containing bypreduct 75 i l (
.aL- s 2. J- 6 ,o A- e>,a- - + - . ~u-- ' ~
m s m er M+o 4 o materialfthat require sealed source and/or_ device review to persons generally licensed under Part 31 of this chapter,_ except specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under-Part 31 of this chapter: Application - New license . . . . . $1,600 Amendment.. .-. . . . . . .
. . . . $290 K. Licenses issued pursuant to Subpart B of Part 32 of this chapter to distribute items containing byproduct material or quantities of byproduct material that do tuu require sealed source and/or device review to persons generally licensed under Part 31 of this
. chapter, except specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under Part 31 of this charcer:
Application - New license . . . . . $1,300 s Amendment . . . . . . . . . . . . . $110 L. Licenses of broad scope for possession and use of byproduct material-issued pursuant to Parts 30 and 33 of-this chapter for.research and development that do 76~
4-not authorize commercial distributions-Application - New license . . . . $4,300 l A:nendment . . . . . . . . . .. . . $660 M. Other licenses for possession and use of byproduct material issued pursuant to Part 30 of this chapter-for research and development that do not authorize comercial distribution: Application - New license . . . . . $1,500 Amendment . . . . . . . . . . . . . $610 N. Licenses that authorize services for other licensees, except: (1) Licenses that authorize only calibration and/or leak testing services are subject to the fees specified in fee Category 3p; and (2) Licenses that authorize waste disposal services are subject to the fees specified in fee Categories 4A, 4B, s and 4C: Application --New license . . . . . $1,900 Amendment . . . . . . . . . . . . . $590 77
-e
. Licenses for1 possession 1and use of: byproduct materialz
~
O. issued pursuantito Part 34lof this-chapter for . industrial radiography operations:- Application - New license . . . . . $3,900 Amendment . . . . . . . . . ., . . $720 P. All other specific byproduct material licenses, except those in Categories 4A through 9D: Application - New license . . . . . . $550 Amendment . . . . . . . . . . . . . , - $300 l
- 4. Waste-disposal and processing: .
. A. Licenses specifically authorizing the receipt of waste bypreduct material, source material, or special nuclear material from other persons for the purpose of
-contingency: storage or commercial land disposal by the.
licensee; or licenses authorizing contingency storage of low-level radioactive waste at the site c2 nuclear power reactors; or licenses for receipt of wast.e from other persons for incineration or other treatmen?., packaging of resulting waste and residues, and transfer of packages to another person authorized to receive or dispose of waste material: 78
,-, - ,w -, --,--,r -- --, - , , -
License, renewal, amendment . . . Pull Cost Inspections . . . . . . .. . . . Full Cost B. . Licenses specifically authorizing the receipt of waste byproduct material, source material, or special nuclear material from other persons for the purpose of packaging or repackaging the material. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material: Application - New license . . . . $3,400 Amendment .... . . . . . . . . $410 C. Licenses specifically authorizing the receipt of prepackaged waste byproduct material, source material, or special nuclear material from other persons. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material: Application - New license . . . . $1,700 Amendment .. . . . . . . . . . . $290
- 5. Well logging:
79 l
A. Licenses _for possession.and use~of byproduct material, source material, and/or special nuclear. material for' well logging, well surveys, and tracer studies other-than' field flooding--tracer studies: Application - New license . . . . $3,200 Amendment . . . . . . . . . . . . $640 B. Licenses for possession and use of byproduct material for field flooding tracer studies: License, renewal, ame:1dment _ . . . Full Cost
- 6. Nu: lear laundries:
A. Licenses for c.ommercial collection and laundry of items contaminated with byproduct material, source material, or special nuclear material: Application - New license . . . . $5,100 Amendment . . . . . . . . . . . . $790 7 ~. Human use of byproduct, source, or special nuclear material: A. -Licenses issued pursuant to Parts 30, 35, 40, and 70 of this chapter-for human use of byproduce material, 80
e source material, or special nuclear material in sealed sources contained in teletherapy devices: Application - New license . . . . $2,800 Amendment . . . . . . . . . . . . $470 B. Licenses of broad scope issued to medical institutions or two or more physicians pursuant to Parts 30, 33, 35, 40, and 70 of this chapter authorizing research and development, including human use of byproduct naterial, excepc licenses for byproduct material, source mate rial, or special nuclear material in sealed sources con ained in teletherapy dev.'.ces: Application - New license . . . . $3,000 Amendment . . . . . . . . . . . . $500 C. Other licenses issued pursuant to Parts 50, 35, 40, and 70 of this chapter for human use of byproduct material, source material, and/or special nuclear material, except licenses for byproduct material, source material, or special nuclear material in sealed sources contained in telecherapy devices: Application - New license . . . . $1,400 Amendment . . . . . . . . . . . . $440 81
- 8. Civil defense:
A. Licensen for possession and use of byproduct material, ; source material, or special nuclear material for civil defense activities: , i Application - Ned license . . . . . $760 t Amendment . . . . . . . . . . . . . $350
- 9. Device, product, or sealed source safety evaluation:
A. Safety evalt'ation of devices or produ:ts containing byproduct material, source material, or special nuclear i material, except reactor fuel devices, for commercial distribution: l Application - each device . . . . $3,400 Amendment - each device . . . . . $1,200 , i B. Safety evaluation of devices or products containing byproduct material, source material, or special nuclear material manufactured in accordance with the unique specifications of, and for use by, a single appliennt, except reactor fuel devics.: r Application - each device . . . . $1,700 82 ,
. _. ._.= _ _ _ _ _ . __ _ _ . _ _ __ _ - _ _ _ .-__ _ . _ . _ . _ .
l j Amendment - each deview . . . . . .
$600 i
l C. Safety evaluation of sealed sources.containing i i' ! byproduct material, source material, or special nuclear -l material, except reactor fuel, for. commercial distributions i l Application - each source . . . . $720 j Amendment - each source . . . . . . $240 D. Safety evaluation of sealed sources containing , byproduct material, source material, or special nuclear - i material, manufactured in accordance with the unique n specifications of, and for use by, a Fingle applicant, l except reactor fuels t Application - each source . . . . . $360 ; Amendment - each source . . .. . . $120 3
- 10. Transportation of radioactive material :
A. Rvaluation of casks, packages, and shipping containers: [ Approval, Renewal, Amendment . . Full Cost - Inspections . . . . . . - . . - , . . . . Full Cost i i 83 ,
+
~ ,- . - . -, - . , - . - . . . - . - , , -- .- . . ~ , - - , . . . - , , , , . , -
k 4 B. Evaluation of 10 CFR Part 71 quality assurance prograins : > t I Application - Approval . . . . . . $340 Amendment . . . . . . . . . . . . $250 Inspections . . . . . . . - . . - . . . Full Cost
- 11. Review of standardized spent fuel facilities:
i Approval, Renewal, Amendment . . Full Cost Inspections . . . . . . . . . . Full Cost.
- 12. Special projectsi'l Approvals and preapplicacion/
licensing activities . . . . . Full Cost Inspections . . . . . . . . . . Full Cost
- 13. A. Spent fuel storage cask Certificate of Compliance Approvals . . . . . . . . . . . . Full Cost-Amendments, revisions, and supplements . . . . . . . . . . Full Cost Reapproval . . . . . . . . . . . Full Cost B ,- Inspections related to-spent fuel storage cask 84 ,
4 h 7 e w-, e e. vs. . n.: , - > , , . , . + - . -.,--.-q--- , ,-~ ,-n,+ - , - c-~,, -~~,- , &
. l
. l Certificate of frinliance . . . . . . Full Cost i
C. Inspections related to storage of spent fuel under
$72.210 of this chapter . . . . . . . . Full Cost p
- 14. Byproduct, source, or special nuclear material licenses and other approvals authorizing decommissioning, i
decontamination, reclamation, or site restoration activities pursuant to 10 CFR Parts 30, 40, 70, and 72 of this chapter: . Approval, Renewal, Amendment . . Full Cost Inspections . . . . . . . . . . Full Cost
- 15. Import and Export licenses:
Licenses issued pursuant to 10 CFR Part 110 of this chapter for the import and export only of special nuclear material, source material, tritium and other byproduct material, heavy water, or nuclear grade graphite. A. Application for export or import of high enriched uranium and other materials, including radioactive waste, which must be reviewed by the Conunissioners and the Executive Branch, for example, those acticas under 10 CFR 110.40(b).. This category includes applicatirq for export or import of radioactive wastes in multiple 85
. }
forms from multiple generators or brokers in the i uporting country r.nd/or going to multiple treatment, j storage or disposal facilities in one or more receiving j i countries. ; Application-new license . . . . . $7,800 i l Amendment . . . . . . . . . . . . $7,800 . B. Application for export or import of special nuclear , material, source material, tritium and other byproduct material, heavy water, or nuclear grade graphite,- l including radioactive waste, requiring Executive Branch t review but not comrrissioner review. This category includes application for the export or import of radioactive ,aste involving a single form of waste fbom , a single class of generator in the exporting country to ; a single treatment, storage and/or disposal facility in , t the receiving country, Application-new license . . . . . $4,800 Amendment . . . . . . . . . . . . $4,800 C. Application for export of routine reloads of low enriched uranium reactor fuel and exports of source material requiring only_ foreign government assurances under-the Atomic Energy Act. s 86 L i I.
0 Application-new license . . . . . $3,000 Amendment . . . . . . . . . . . . $3,000 D. Application for export or import of other materials, including radioactive waste, not requiring Commissioner review, Executive Branch review, or foreign government assurances under ths Atomic Energy Act. This category includes application for export or import of radioactive waste where the NRC has previously authorized the export or import of the same form of waste to or from the same or similar parties, requiring only confirmation from the receiving facility and licensing authorities that the shipments may proceed according to previoucly agreed understandings and procedures. Application-new license . . . . . $1,200 Amendment . . . . . . . . . . . . $1,200 E. Minor amendment of any export or import license to extend the expiration date, change domestic information, or make other revisions which do not require in-depth analysis, review, or consultations with other agencies or foreign governments. Amendment . . . . . . . . . . . . . $120 87
- 16. Reciprocity: i Agreement State licensees who conduct activities in a non- i Agreement State under the reciprocity provisions of 10 CFR t
150.20. Application (initial filing of i Form 241) . . . . . . . . . . $1,100 , Revisions . . . . . . . . . . . $200 ; F_Iypsr f fees - Separate charges,.as shown in the schedule, will ; assessed for preapplication consultations and reviews and applications for new licenses and approvals, issuance of new licenses and approvals, amendments and certain renewals to existing licenses and approvals, safety evaluations of sealed , sources and devices, and certain inspections. The following guidelines apply to these charges (a) Aeolication fees. App 1dcations for new materials licenses and approvals; applications to reinstate expired, terminated or inactive licenses and approvals except those subject to fees assessed at full costs, and applications filed by Agreement State licensees to register under the general license provisions of 10 CFR 150,20, must be accompanied by the prescribed application fee for each category, except that: 88
(1) Applications for licenses covering more than one fee category of special nuclear material or source material must i be accompanied by the preteribed application fee for the highest fee category; and ; (2) Applications for licenses under Category 1E must ; be accompanied by the prescribed application fee of $125,000. ; i (b) License /anoroval/ review fees. Fees for applications for new licenses and approvals and for preapplication , consultations and reviews subject to full cost fees (fee Categories 1A, 1B, 1E, 2A, 4A, SB, 10A, 11, 12, 13A, and 14) are due upon notification by the Commission in accordance with 5170.12(b), (e), and (f). (c) Renewal /rencoroval fees. Applications subject to full cost fees (fee Categories 1A, 1B, 1E, 2A, 4A, SB, 10A, 11, 13A, and 14) are due upon notification by the Commission in accordance with S170.12(d). 4 b (d) Amendment / Revision Fees. (1) Applications for amendments to licenses and approvals ) and revisions to reciprocity-initial applications, except those l subject to fees assessed-at full costs. must be accompanied by l the prescribed amendment / revision fee fo, Tach license / revision 89
--- gr r. - - +-yw4,, ,w wpv-- -
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9 -pe,p - - , s 9-
affected. An application for an amendment to a license or approval classified in more than one fee category must be [ accompanied by the prescribed amendment fee for the category j affected by the amendment unless the amendment is applicable to , I two or more fee categories in which case the amendment fee for. [ the highest fee ettegory would apply. For those licenses and approvals subject to full costr (fee Categories 1A, 1B, IE, 2A, , 4A, 5B, l'A, 0 11, 12, 13A, and 14), amendment fees are due upon notification by the Commission in accordance with 5170.12 (c) . j t l (2) An application for amendment to a materials license or approval that would place the license or approval in a higher fee category or add a new fee category must be accompanied by the prescribed application fee for the new category. j (3) An application for amendment to a license or approval that would reduce the scope of a licensee's program to a lower fee category must be accompanied by the prescribed amendment fee for the lower fee category. (4) Applications to terminate licenses authorizing small materials programs, when no dismantling or decontamination procedure'is required, are not subject to fees. (e) Insoectien fees. Inspactions resulting from investigations conducted by the Office of Investigations and 90
--w,, .,.. . . , , - . - . , , , , . - , . , _ , , ,. - . - - , ,..r.. , - . , y--n - - - , - - -v, y----
nonroutine inspections that result from third-party allegations , are not subject to fees. The fees assessed at full cost will be determined based on the professional staff time required to conduct the inspection multiplied by the rate established under 5170.20 plus any applicable contractual support services costs incurred. Inspection fees are due upon notification by the Commission in accordance with 5170.12 (g) . l' Fees will not be charged for orders issued by the Commission pursuant co 10 CFR 2.202 or for amendments resulting specifically from the requirements of these types of Commission orders. However, fees will be charged for approvals issued under a specific exemption provision of the Commission's regulations under Title 10 of the Code of Federal Regulations (e.g., 10 CFR 30.11, 40.14, 70.14, 73.5, and any other sections now or hereafter in effect) regardless of whether the approval is in the form of a license amendment, letter of approval, safety evaluation report, or other form. In addition to the fee shown, an applicant may be assessed an additional fee for sealed source and device evaluations as shown in Categories 9A through 9D. l' Pull cost fees will be determined based on the professional staff time and appropriate contractual support services expended. For those applications currently on file and for which fees are determined based on the full _ cost expended for the review, the ; professional staff hours expended for the review of the 91 !
_- - -= -- -. _ . . - _ .- . . - . . -- application up c: the effective date of the final rule will be determined at the professional rates in effect at the time the' service was provided. For applications currently on file for " which review costs have reached an applicable fee ceiling established by the June 20, 1984, and July 2, 1990, rules, but are still pending completion of the review, the cost incurred after any applicable ceiling was reached through January 29, 1989, will not be billed to the applicant. Any professional staff-hours expended above those ceilings on or after January 30, , 1989, will be assessed at the applicable rates established by 5170.20, as appropriate, except for topical reports whose costs exceed $50,000. Costs which exceed $50,000 for each topical report, amendment, revision, or supplement to a topical report completed or under review from January 30, 1989, through August 8, 1991, will not be billed to the applicant. Any professional hours expended on or after August 9, 1991, will be assessed at the applicable rate established in S170.20. The udnimum total review cost is twice the hourly rate shown in 5170.20. i' Licensees paying fees under Categories 1A, la, and 1E are not subject to fees under Categories 1C and ID for sealed sources authorized in the same license except in those instances in which an application deals only with the sealed sources authorized by the license. Applicants for new licenses that cover both byproduct natorial and special nuclear material in sealed sources for use in gauging devices will pay the appropriate application 92
9 fee for fee Category 1C only. l' Fees will not be assessed for requests / reports submitted to the NRC: (a) In response to a Generic Letter or NRC Bulletin that does not result in an amendment to the license, does not result in the review of an alternate method or reanalysis to meet the requirements of the Generic Letter, or does not involve an unreviewed safety issues (b) In response to an NRC request (at the Associate Office Director level or above) to resolve an identified safety or environmental issue, or to assist NRC in developing a rule, regulatory guide, policy statement, generic letter, or bulletin; or (c) As a means of exchanging information between industry organizations and the NRC for the purpose of supporting generic regulatory improvements or efforts. s PART 171 -- ANNUAL FEES FOR REACTOR OPERATING LICENSES AND FUEL CYCLE LICENSES AND MATERIALS LICCNSES, INCLUDING HOLDERS OF CERT.TFICATES OF COMPLIANCE, REGISTRATIONS. AND QUALITY ASSURANCE PROGRAM APTROVALS AITD GOVERNMENT AGENCIES LICENSED BY THE NRC. l 93
i
- 6. The authority citation for Part 171 continues to read as follows:
Authority: Sec. 7601, Pub. L. 99 272, 100 Stat. 146, as amended by sec. 5601, Pub. L. 100-203, 101 Stat. 1330, as amended by Sec. 3201, Pub. L. 101-239, 103 Stat. 2106 as amended by sec. 6101, Pub. L. 101-508, 104 Stat. 1388, (42 U.S .C. 2213); sec. 301, Pub. L. 92-314, 86 Stat. 222 (42 U.S.C. 2201(wl); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 2903, Pub. L. 102-486, 106 Stat. 3125, (42 U.S.C. 2214 note) .
- 7. In S171.15, paragraph (d) is removed aid reserved and paragraphs (a), (b), (c) (1) , (c) (2) and (e) are revised to read as follows:
E171.15 Anqt;,:11 Fees Reactor coeratino licenses. (a) Each person licensed to operate a power, test, or research reactor shall pay the annual fee for each unit for which the person holds an operating license at any time during the Federal IT in which the fee is due, except for those test and research reactors exempted in $171.11(a) (1) and (a) (2) . (b) The FY 1996 uniform annual fee for each operating power reactor which must be collected by September 30, 1996, is I $2.746,000. This fee has been determined by adjusting the FY 94
\
i 1995 annual fee downward by approximately 6 percent. The FY 1995 , annual fee was comprised of a base annual fee and-an addir.ional ! charge (surcharge). The actiarities comprising the base FY 1995 annual fee are as follows: (1) Power reactor safety and safeguarde regulation except licensing and inspection activities recovered under 10 CFR Part 170 of this chapter. ; (2) Research activities directly related to the rugulation of power reactors. (3) Generic activities required largely for NRC to L*egulatu power reactors, e.g., updat.ing Part 50 of this chapter, or operating the Incident Response Center. (c) The activities comprising the FY 1995 surcharge are as follows: (1) Activities not attributable to an existing NRC licensee or class of licensees; e.g., reviews submitted by other government agencies (e.g., DOE) that do not result in a license or are not associated with a licenses international cooperative ) i safety program and international safeguards activities; low-level waste disposal generic activities; uranium enrichment generic l activities; and ! 95 l
-. . - . ._ . - _._ -._ - . _ ~ . . - _ - - . - - . - . - . . - . ._
~
(2) Activf, ties not currently assessed under 10 CFR Part 170 licensing and. inspection fees based on existing Commission policy, e.g., revicws and innpactions conducted of nonprofit educational institutions, and costs that would not be collected l from small entities based on Commission policy in accordance with ;
'the Regulatory Flexibility Act.
f , (d) (Reserved). (e)- The FY 1996 annual fees for licensees authorized to-operate a nonpower (test and research) reactor licensed under Part 50 of this chapter, except for those reactors exempted from f ees under $171.11(a) , are as follows: l Research reactor
$52,800 ,
Test reactor $52,800 L 4 l
- 8. In 5171.16, the introductory text of paragraph (c) and ,
Paragraphs (c) (1), (c) (4) , (d), and (e) are revised to read as. follows: E171.16 Annual Feas Materials Licensees. Holders of
-96 l-
'I
O t Certificates of ceweliance, Holders of Sealed Source and Device ! Reaistrations. Holders of Quality Assurance Proaram Anorovals and l Government aaencias licensed by the NRC, 1 i . . . . * ; (c) A licensee who is required to pay an annual fee under , I this section may qualify as a small entity. If a licensee PI qualifies as a small entity and provides the comission with the ! proper certification, the licenses may pay reduced annual fees l t for FY 1996 as follows: j Sgnpli Businesses Not Enamaad Mavimum Annual Fee in Manufacturina and Small Per Licensed Cateacry Hot-For-Profit Oraanizations (Gross Annual Receints) 3
$350,000 to $5 million $1,800 Less than $350,000 $400 ,
~ Manufacturina entities that ; have an averman of SQQ emnievens or inar, 35 to 500 employees $1,800 Less than 35 employees $400 small Governmental Jurisdictions (Includina nubliciv sunnerted educational institutions) _ (Ponulation)
- 20,000~to 50,000 $1,800 l Less'than 20,000 $400 .
Educational Institutions that are not State or Publicly ' 9 *1 y-, - 4-,-9 -e- , .r3- ep. - . - _ .....-.,e. --c,m,.,..,e,, .mc.,.,eow.,,,,,,..,.n,.-.,.w.,....,...,,--,.%.e,% ,.-y., ...74.,-v., .y--. . ..m- , --.w... , , , . . ,
1
- l l
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Sunnortad, and have 500 Emnlovaes , er Lass. , f 35 to 500 empicyees $1,800 l Less than 35 employees $400 , (1) A licensee qualifies as a small entity if it meets the . I size standards attablished by the NRC (See 10 CFR 2.810) . j (4) For FY 1996, the maximum annual fee a small entity is required to pay is $1,800 for each category applicable to the license (s). (d) The FY 1996 annual fees for materials licensees and - . holders of certificates, registrations or approvals subject to l fees under this section are shown below. The FY 1996 annual fees, which rust be collected by September 30, 1996, have been I determined by adjusting downward the FY 1995 annual fees by approximately 6 percent. The FY 1995 annual fee was comprised of a base annual fee and an additional charge (surcharge). The act!vities comprising the FY 1995 surenarge are shown in paragraph (e) of this section. (' SCHEDULE OF MATERIALS ANNUAL FEES
.AND FEES FOR GOVERNMENT AGENCIES LICENSED BY NRC (See footnotes at and of table) '
98 1
- - . . = _ . - ., - - - . - . - _ - - - - - - - . _ _ . . - - - . - . - - - - . --
t Cateaory of materials licenses Annual FeesMa E' E I
.1. Special nuclear material:
A. (1) Licenses for possession and use of U-235 or plutonium for fuel fabrication activities. (a) Strategic Special Nuclear Material: Babcock & Wilcox SNM-42 $2,403,000 Nuclear Fuel Services SNM-124 $2,403,000 (b) Low Enriched Uranium in Dispersable Form Used for Fabrication of Power Reactor Puel: Combustion Engineering (Hematite) SNM-33 $1,179,000 General Electrie Company SNM-1097 $1,179,000 Siemens Nuclear Power SNM-1227 $1,179,000 l Westinghouse Electric SNM-1107 $1,179,000 Company I (2) All other special nuclear materials licenses not 99
. . = . . . - - - .. - - - - - . - - - - - ,
- . - . - l
1 1 included in Category 1.A.(1) which are licenJed for fuel cycle activities. l (a) Facilities with limited operations: B&W Puel Company SNM-1168 $469,200 (b) All others: General Electric SNM-960 $318,600 B. Licenses for receipe and storage of spent fuel at an independent spent ! fuel storage installation (ISFSI). $260,900 C. Licenses for possession and use of special nuclear material in sealed sources contained in devices used in industrial measuring systems, including x-ray fluorescence analyzers. $1,200 D. All other special nuclear material licenses, except licenses authorizing special nuclear material in unsealed form-in combination that would constitute a-critical quantity, as defined in 5 150.11 of this chapter, for which . 100
,..<r , , - > - - . . , - - - - - , ,, +- e- +-., ,. - - - - . - ,
. l the licensee shall pay the same fees
) as those for Category 1.A.(2). - $2,800 Y i h E. Licenses for the operation of a i uranium enrichment facility. $ N/Auf l 2. -Source material: I l l A. (1) Licenses for possession and use of j source e.aterial for refining-uranium i mill concentrates to uranium hexafluoride. $597,800 ,
?
i 4 (2) Licenses for possession and u.T-of : source material in recovery operations such'a6 milling, in-situ leaching, ; i heap-leaching, ore buying stations, ion exchange facilities and in processing of ores conteining source material for extraction of metals other than uranium 3.- or thorium, including licenses authorizing 1 l the possession of byproduct waste material i (tailings) from source material recovery operations,_as well as licenses authorizing ; the possession and maintenance of a facility l in a standby mode. 1 101-i
,u 1,.~y.' - ,[,,,a.-,_---,,.,-%~ , - , , , . . , , ,,.m. . + , , . ,~,,,.,_,w.-,, o_4 - . ,
\
Class I facilities' . . . . . . . $57,000 l i Class II f acilities' . . . . . . . $32,200 Other f acilities' . . . . . . . $20,600 1 (3) Licenses that authorize the receipt of byproduct material, as defined in Section 11e. (2) of the Atomic Energy Act, from other persons for possession and disposal, except those licenses subject to the fees in Category 2.A.(2) or Category 2. A. (4) . $41,800 (4) Licenses that authorize the receipt of byproduct material, as defined in Section 11e(2) of the Atomic Energy Act, from other persons for possession and disposal incidental to the disposal of the uranium waste tailings generated by the licensee's milling operations, except those licenses subject to the fees in Category 2. A. (2) . $7,400 B. Licenses which authorize only the possession, use and/or installation of source material for shielding. $450 C. All other source material licenses. $8,100 102
. . . , _ - , + ,.y..- - - - - ,- - - -, -
- i f
c
'3. Byproduct material:
A. Licenses of broad scope for possession and use of byproduct material issued pursuant to' Parts 30 and 33 of this chapter for processing or manufacturing : of items containing byproduct material j for commercial distribution. $15,400 B. Other licenses for possession and use of byproduct material issued pursuant to Part 30 of this chap';er for processing or manufacturing of items containing byproduct material for , , commercial distribution. $5,200 C. Licenses issued pursuant te 5532.72, 32.73, and/or 32.74 of this chapter authorizing the processing or manufacturing and distribution or redistribution of radiopharmaceuticals, s , generators, reagent kits and/or sources and devices containing byproduct material. This category also includes the possession and use of source material for. shielding
. authorized pursuant to Part 40 of this 103
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chapter when included on the same , license. $10,400 D. Licenses and approvals issued pursuant to 5532.72, 32.73, and/or - 32.74 of this chapter authorizing distribu-tion or redistribution of radiophar-maceuticals,-generatris, reagent kits and/or sources or devices not involving processing of byproduct material. This : category also includes the possession and use of source material for shielding arthorized pursuant to Part 40 of this chapter when included on the same ; license. $4,100 U. Licenses for possession and use of byproduct material in sealed sources for irradiation of materials in which the source is not removed from its shield (self-shielded units). $2,900 s F. Licenses for-possession and use of less , than 10,000' curies of byproduct material in sealed sources for irradiation of waterials in which the= source is exposed l 104-i I i
for irradiation purposes. This category also includes underwater irradiators for irradiation of materials in which tha source is not exposed for irradiation purposes. $3,500 G. Licenses for possession and use of 10,000 curies or more of byproduct material in sealed sources for irradiation of materials in which the so'urce is exposed for irradiation purposes. This category also includes underwater irradiators for irradiation of materials in which the source is not exposed for irradiation purposes. $18,100 H. Licenses issued pursuant to Subpart A of Part 32 of this chapter to distribute items containing byproduct material that require device review to persons exempt from the licensing requirements of Part 30 of this chapter, except specific licenses authorizing redistribution of items that have been authorized for distribution to persons exempt from the licensing requirements of Part 30 of this 105
- -... . . . . . ~ .- . . . . . -- - . _ ..-_ - . - - - _ . - . -- - - --
1 chapter. $4,600 I. Licenses issued purruant to Subpart A of Part 32 of this chapter to distribute j i items containing byproduct material or , quantities of byproduct material that do not require device evaluation to , persons exempt from the licensing requirements of Part 30 of this chapter, except for specific licenses authorizing i redistribution of items that have been authorized for distribution to' persons exempt from the licensing requirements of Part 30 of this chapter. $6,200 J. Licenses issued pursuant to Subpart B , of Part 32 of this chapter to distribute , items containing byproduct material that require sealed source and/or device review to_ persons generally licensed under Part 31 of this chapter, except , specific licenses authorizing redistribution of-items that have been authorized for distribution to persons generally licensed under Part 31 of this chapter, $3,500 i 106 i t e---4 - ,ys6 - - - -ve ye vr . --w.cr -., ,-,h4.--.mre-%-r-- w++-'-,--ww-=<se.--- -
- r w trev-rmem-------n -,e am--- - --v-* -
is- -. - -
K. Licenses issued pursuant to Subpart B of Part 31 of this chapter to distribute items containing byproduct material or quantities of byproduct material that do not require sealed-e- rce and/or device review to persons gsnarally licensed under Part 31 of this chapter, except specific licenses authorizing redistribution of items that have been authorized for distribution to persons generally licensed under Part 31 of this chapter. $3,000 L. Licenses of broad scope for possession and use of byproduct material issued pursuant to Parts 30 and 33 of this chapter for research and development that do not authorize commercial distribution. $11,400 M. Other licenses for possession and use of byproduct material issued pursuant to Part 30 of this chapter for research and development that do not authorize commercial distribution.- $5,100 107
N. Licenses that authorize services for . other licensees, except: ( '. Licenses that authorize only l calibration and/or leak testing services are subject to the fees specified in fee Category 3P; and (2) Licenses that authorize waste disposal
]
services are subject to the-fees specified ) in fee Categories 4A, 4B, and 4C. $5,600
- 0. Licenses for possession and use of I
l byproduct meterial issued pursuant to , Part 34 of this chapter for industrial radiography operations. This category also includes the possession and use of source material for shielding authorized pursuant to Part 40 of this-chapter when authorized on the same license. $13,000 P. All other specific byproduct material licenses, except those in Categories 4A through 9D. $1,600 t
- 4. Waste disposal;and_ processing:
108 4 t-t
E t.. ,
*:enses specifically authorizing the
-ceipt of waste byproducc material, source material, or special nuclear material frca other persens for the purpose of contingency storage or
} commercial land disposal by the licenseen or licenses authorizing cont.ingency storage of low-level
;mdioactive waste at the site of ) nuclear power reactore; or licenses for receipt of waste from other persons for incineration or other r
treatment, packaging of resulting waste and residues, and transfer of packages to another person authorized to receive or dispose of waste material. $94,3J0ll B. Licenses specifically authorizing the receipt of waste byprocact material, source material, or special nuc3:ar material from other persons for the purpose of phekaging or repackaging the material. The licensee will dispose of the material by transfer to another person authorizvd to 109 1
I receive or dispose of the material. $13,300 C. Licenses specifically authorizing the receipt of prepackaged waste byproduct material, source material, or special nuclear material from other perr,ons. The licensee will dispose of the material by transfer to another person authorized to receive or dispose of the material. $7,100
- 5. Well logging:
A. Licenses for; possession and use of byproduct material, source material, and/or opscir.1 nuclear material for well logging, well surveys, and tre.cer studies other than field flooding tracer studies. - $7,500 B. Licenses for possession and use of byproduct material for field flooding tracer studies. $12,200
- 6. Nuclear laundries:
110
1.- _, A. -Licenses'for' commercial-collection end laundry of items contaminated with byproduct. material, source material, or special-nuclear material. $13,600 ,
- 7. Human use of byproduct, source, or special nuclear material.
A. Licenses issued pursuant to Parts 30, 35, 40- and 70 of this chapter for human use of byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devicos. This category also includes the possession and use of source material for shielding when authorized on the.same license. 69,500
.B. Licenses of broad scope issued to medical institutions or two or more.
. physicians pursuant to-Parts 30, 33, s
35, 40, and 70 of this chapter-I authorizing research and development, , including. human.use.of byproduct
~ material exceptolicenses for byproduct material, source material, or special 111
_ _ - ._ =
Iwelear material in sealed sources t contained in teletherapy devices. This category also includes the possession and use of source material for shielding when authorized on the same license.F $21,700 C. Other licenses issued pursuant to Parts 30, 35, 40, and 70 of this chapter for human use of byproduct material, source material, and/or special nuclear material except licenses for byproduct material, source material, or special nuclear material in sealed sources contained in teletherapy devices. This category also includes the possession and use of source material for shielding when authorized on the same license.F $4,300
- 8. Civil defense:
A. Licenses for possession and use of byproduct material, source materiL1, or special nuclear material for civil defense activities. $1,600 112
9., Device,1prbduct, :nr sealed source safety evaluation: ' A .- Registrations issued for the. safety' evaluation of devices ~or products containing byproduct naterial, source , material, or special nuclear material, except reactor fuel devices, for commercial distribution. $6,700 J
- 3. Registrations issued for the safety evaluation of' devices or products containing byproduct material, sor.rce material, or special nuclear material manufactured in acccardance with the .
unique specifications of, and for'use by, a single applicant, except reactor fuel devices. $3,400 C. Registrations issued for the safety evaluation of sealed sources containing byproduct material, source material, or special nuclear material, except reactor fuel, for commercial distribution. $1,400 D. Registrations issued for the safety. 113
evaluation of sealed sources containing byproduct material, source material, or special nuclear material, manufactured in accordance with the unique specifications of, and for use by, a single applicant, except reactor fuel. $720
- 10. Transportation of radioactive matterial:
A. Certificates of Compliance or other package approvals issued for design of casks, packages, and shipping containers. Spent Fuel, High-Level Waste, and N/A'i plutonium air packages Other Casks N/A'i B. Approvals issued of 10 CFR Part 71 quality assurance program, s Users and Fabricators $72,700 Users $950
- 11. Standardized spent fuel facilities. N/A'l 114 1
- 12. Special Projects N/A'l
- 13. A. Spent fuel storage cask Certificate N/A'!
of Compliance. b B. General licenses for storage of $260,900 spent fuel under 10 CFR 72.210.
- 14. Byproduct, source, or special nuclear N/A'l material lic.enses and other approvals authorizing decommissioning, decontamination, reclamation, or site restoration activities s
f pursuant to 10 CFR Parts 30, 40, 70, and 72.
- 15. Import and Export licenses N/A'l
- 16. Reciprocity N/A'l
- 17. Master materials licenses of broad $388,400
[ scope issued co Govtrnment agencies.
- 18. Department of Energy:
A. Certificates of Compliance . . . . . $1,077,000H' B. Uranium Mill Tailing Radiation Control Act (UMTRCA) activities . . . . . . $1,812,000
=
115
1 1 l' Annual fees will be assessed based on whether a licensee held a valid license with the NRC authorizing possession and use of radioactive material during the fiscal year. However, the annual fee is waived for those materials licenses and holders of certificates, registrations, and approvals who either filed for termination of their licenses or approvals or filed for possession only/ storage licenses prior to October 1, 1995, and permanently ceased licensed activities entirely by September 30, 1995. Annual fees for licensees who filed for termination of a license, downgrade of a license, or for a POL during the fiscal year and for new licenses issued during the fiscal year will be prorated in accordance with the provisions of 5171.17. If a person holds more than one license, certificate, registration, or approval, the annaal fee (s) will be assessed for each license, certificate, registration, or approval held by that person. For licenses that authorize more than one activity on a single license (e.g., human use and irradiator activities), annual fees will be assessed for each category applicable to the license. Licensees paying annual fees under Category 1. A. (1) are not subject to the annual fees of Category 1.C and 1.D for sealed sources , authorized in the license. l' Paynent of the prescribed annual fee does not automatically renew the license, certificate, registration, or approval for which the lee is paid. Renewal applications must be filed in accordance with the requirements of Parts 30, 40, 70, 71, or 72 116 l l
L. 4 of'this_ chapter. I' For FYs 1997 and 1998, fees for these materials licenses will be calculated and assessed in accordance with 5171.13 and will be published in the Federal Register for notice and comment. A' A Class I license includes mill licenses issued for the extraction of uranium from uranium ore. A Class II license includes solution mining licenses (in-situ and heap leach) issued for the extraction of uranium from uranium ores including research and development licenses.- An "other" license includes ) licenses for extraction of metals, heavy metals, and rare earths. l' Two lic0nses have been issueo by NRC for land disposal of special nuclear material. Once NRC issues a LLW disposal license for byproduct and source material, the Commission will consider establishing an annual fee for this type of license. F Standardized spent fuel facilities, Parts 71 and 72 Certificates of Compliance, and special reviews, such as topical reports,,are not assessed an annual fee because the generic costs of regulating these activities are primarily attributable to the users of the designs, certificates, and topical reports.
.UJL icensees in this category are not assessed an annual fee because-they are charged an annual fee in other categories while 117
i a: j they,are/ licensed to operate. l
+
1 l' No .annualJf ee----is : charged because it4 is not! practical to administer.due to the-relatively,short' life or. temporary nature: -
-of the license.- ;
l' Separate annual' fees will not be assessed for pacemaker-licenses issued to medical institutions who also hold nuc3 ear-
. medicine licenses under Categories 7B or 7C.
M'-This includes Certificates of Compliance issued to DOE that are not under the Nuclear Waste Fund. MI No annual' fee has been established-because there are, currently no licensees in this particular fee category- . (e) The activicies comprising the FY 1995 surcharge are as L follows: ' 1 l L (1)- LLW disposal generic activities; (2) . Activities not attributable.to an. existing NRC licensee-p l:t or classes-of. licensees;-e.g., international cooperative. safety
- program and international: safeguards activities;-support;for the Agreement State-program; site-decommissioning management plan
-(SDMP) L activities; and
? l8 -
l
. z .. . :. , . . ,. , . - - . . -
,..- , ..l
7 j (3) Activities not currently-assessed under 10 CFR Part-170
. licensing and inspection fees based on existing law or Commission policy,-'e.g., reviews and inspections conducted of nonprofit
- eaucationalJinstitutions and Federal agencies; activities _related o
to decommissioning and reclamation and costs that would not be g collected .from small entities based on Comission policy in accordance with the Regulatory Flexibility Act.
..... 4
's . In $171.19, paragraphs (b) and (c) are revised and a nrs paragraph (d) is added to read as follows:
E171.19 Pavmant. (b) For FY 1996 through FY-1998, the Cotmission will adjust the : fourth quarterly bill for . operating power reactors - and certain materials licensees to recover the-full amount of the revised annual fee. If the amounts collected in the first three
-quarters exceed the amount of the revised annual fee, the overpayment will be refunded. The.NRC will rafund any " flat" materials renewal fees payments received for renewal applications filed-in FY 1996, as-appropriate. All other licensees,-or-holders of a certificate, registration, or approval of a QA program will be sent a bill for the full amount of.the annual fee 119
4 upon publication of.the final rule or on the anniversary date of , the license. - Payment is due on the invoice date and interest accrues from the date of the invoice. However, interest will be waived it. payment is' received within 30 days from the invoice date.
-(c) For FYs 1996 through 1998, annual fees in the amount of $100,000 or more and described in the Federal Register notice pursuant to 5171.13 must be paid in quarterly installments of 25 percent ar> billed by the NRC. The quarters begin on October 1, January 1, April 1, and July 1 of each fiscal year.
(d) For FYs 1995 through 1998, annual fees of less than
$100,000 must be paid as billed oy the NRC. Beginning in FY 1996, materials license annual fees that are less than $100,000 will be billed on the anniversary of the license. The materials licensees that will be billed on the anniversary date of the license are~those covered by fee categories 1.C. and 1.D.;
2.A.(2) through 2.C.; 3.A. through 3.P.; 4.B. through 9.D.; and 10.B. For annual fee purposes, the anniversary date of the license is considered to be the first day of the month in which the original license was issued by the NRC. During the transition year of FY 1996, licensees with license anniversary dates falling between October 1, 1995, and the effective date of the FY.1996 final-rule will raceive an annual fee bill payable on the effective date of the final rule, and licensees with license 120
c. 3 anniversary dates that fall on or after the effective date of the-final rule will be billed on the anniversary of their license. Starting with the^ effective date of the FY 1996 final rule, 1 1 - licensees that are billed on the_ license anniversary date-will be assessed the annual fee in effect on the anniversary-date of the I license. Dated at Rockville, Maryland, .this g_ ay of M, 1996. For the Nuclear Regulatory Commission.
, sf .
[J / ? Ja - . Taylog ive Director for' Operations.
.g.
1 121 6; i i.
4 APPENDIX A TO THIS' FINAL RULE , REGULATORY FLEXIBILITY ANALYSIS FOR THE. AMENDMENTS TO 10 CFR PART 170 (LICENSE FEES) AND 10 CFR PART 171 (ANNUAL FEES) J I. Background. The Regulatory Flexibility Act of 1980 (5 U.S.C.-601 et seq.) establishes as a principle of regulatory _ practice that agencies endeavor to fit regulatory and informationhl requirements, consistent with applicable statutes, to a scale commensurate with the businesses, organizations, and government jurisdictions to which they apply. To achirve this principle, the.Act requires that agencies consider the-impact of their actions on small entities. If the agency cannot certify that a rule will not significantly impact a substantial number of small entities, then a regulaSory flexibility analysis is required to examine the impacts on small entities and the alternatives to minimize these impacts. To assist in considering these impacts under the Regulatory
' Flexibility Act (RFA), first the NRC adopted size standards for determining which NRC~ licensees qualify as small entities (50 FR
-50241;-December.9, 1985, These size' standards were clarified November 6,11991 (56 FR 5t672). On April'7, 1994 (59 FR 16513),
-the Small Business Administ;ation (SBA)-issued a final rule 122 e
. ~. .. _,
changing-its size' standards. The SBA adjusted its-receipts-based size ,standarde levels to udtigate the effects of inflation from 1984 to 1994. On November 30, 1994 (59 FR - 612 93 ) , the NRC published a proposed rule to amend its size standards. After evaluating the two commenth received, a final rule that would revise the NRC's size standards as proposed was developed and approved by the SBA on March 24, 1995. The NRC published the final rnJe revising its size standards on April 11, 1995 (60 FR 18344). The revised standards became effective May 11, 1995. The revised standards adjusted the NRC receipts-based size standards from $3.5 million to $5 million to accommodate inflation and to conform to the SBA final rule. The NRC also eliminated the separate $1 million size ctandard for private practice physic 3ans and applied a receipts-based size standard of
$5 ndllion to this class of licensees. This mirrored the revised SBA standard of $5 million for medical practitioners. The NRC also established a size standard of 500 or fewer employees for business concerns that are manufacturing entities. This standard is the most commonly used SBA employee standard and is the standard applicable to the types of manufacturing industries that hold an NRC license.
s The NRC used the revised standards in the final FY 1995 fee rule and is using them in this FY 1996 final rule. -The small entity fee categories in 5171.16(c) of this final rule reflect ; the changes in-the NRC's size standards adopted in FY 1995. A 123
newLmaximum small entity fee for manufacturing industries with 35 oto 500 employees was established at $1,800 and a lower-tier small entityffee of $400 was established for those manufacturing industries with lasc than 35 employees. The lower-tier receipts-based threshold of $250,000 was raised to $350,000 to reflect approximately the same percentage adjustment as that made by the SBA when they adjusted the receipts-based standard from $3.5 million to $5 million. The NRC believes that continuing these actions-for FY 1996 will reduce the impact of annual fees on small businesses. The NRC size standards are codified at 10 CFR 2.810. Public Law 101-508, the Omnibus Budget Reconciliation Act of 1990 (OBRA-90), requires that the NRC recover approximately 100 percent of its budget authority, less appropriations from the Nuclear Waste Fund, for Fiscal Years. (FY) 1991 through 1995 by assessing license and annual fces. OBRA-90 was amended in 1993 to extend the 100 percent recovery requirement for NRC through 1998. For FY 1991, the amount for collection was approximately
$445.3 million; for FY 1992, approximately $492.5 million; for FY 1993 about $518.9 million; for FY 1994 about $513 million; for FY 1995 about $503.6 million and the amount to be collected in FY 1996 is approximately $462.3 ndllion.
To comply with OBRA-90, the Commission amended its fee regulations in 10 CFR Parts 170 and 171 in FY 1991- (56 FR 31472; 124
1 of /. <
.g.
l July 10, 1991) fin FYE1992,-(57 FR 326fis July 23, 1992) in'FY 1993 (58 FR 38666;^ July 20, 1993)'in FY 1994 (59 FR 36895; July 20;~1994) and in FY 1995 (60-FR 32218; June-20, 1995) based on a careful evaluation of over 1,000 comments. These final rules established the methodology used by NRC in identifying-and
-determining the fees assessed and collected in FYs 1991-1995.
The NRC-indicated in the FY 1995 final rule that it would attempt to stabilize annual fees as follows. Beginning-iu FY 1996, it.woul3 adjust the; annual fees only byLthe percentage change -(plus-or minus) in NRC's total budget authority unless
-thera war a substantial change in the total NRC budget-authority or the magnitude of the budget allocated to a specific class of licensees, in which case the annual fee base would be -
recalculated (60 FR 32225; June 20, 1995). The NRC also indicated that the percentage change would be adjusted based on changes:in the 10 CFR Part-170 fees and other receipts as well as an adjustment for the number of licensees paying the fees. As a-result,Jthe NRC is establishing the FY 1996 annual-fees for all licensees at 6.5 percent below-the FY 1995 annual fees. . The NRC
-believes thatLthe 6.5 percent _ downward adjustment to the FY 1995-annual fees-is not a substantial enough change to warrant establishing!a new baseline for FY 1996.
c The NRC is also continuing to-streanline the fee structure- : 1 and procesu for materials licenses, efforts which began in FY 125
1995. Two changes are being nade in this area. . First, the NRC will assess annual fees for certain materials licenses on the anniversary date of the license. Billing certain materials licenses on the anniversary date of the license will allow NRC to make improved efficiencies in the billing proces2 whereby approximately 500 annual fee invoices will be Pent to materials licensees each month. The current practice of billing over 6,000 materials licensees at the same time in the fiscal year is eliminated. The NRC believes that the efficiencies gained by billing certain materials annual fees on a monthly ba.ad.s as well as materials licensees knowing exactly when they will be billed each year for the annual fee cutweigh the inconveniences that may be caused during the FY 1996 transition period. Second, the NRC is further streamlining the materials fee program and improving the predictability of fees by eliminating the materials " flat" renewal fees in 5170.31. This action is consistent with the NRC's recent Business Process Reengineering initiative to extend the duration of certain materials licenses, s The NRC published a proposed rule explaining this initiative in the Federal Register on September 8, 1995, (60 FR 46784). In the proposed rule, certain materials licenses would be extended for five years beyond their expiration date. Additionally, comments were requested on the general topic of the appropriate duration 126
n 4 y- ~ of;1icenses.--Anfinal rule was published.in'the Federal Register
- on January-16L?1996 (61 FR 1109).-
-II . Imnact en small entities.
The comments received on the proposed-FY 1991-1995 fee ruit, revisions and the small entity certifications received-in response'to-the final FY 1991-1995 fee rules indicate that NRC
-licensees qualifying as small entities under the NRC's size standards-are primarily those licensed under the NRC's materials program. Therefore, this analysis will-focus on the economic impact of the annual fees on materials licensees.
I The Commission's fee regulations result in substantial fees i being charged to those individuals, organizations,-and companies a that are licensed under the NRC materials program. Of these 1 ]- materials licensces, about 18 percent (approximately 1,300 licensees) have requested small entity certification in the past. L In:FY 1993, the NRC conducted a survey of its materials licensees. The results of this survey indicated that about 25
= percent of-these licensees could= qualify .as small entities under i the current:NRC size standards, t
-The~commenters on the FY 1991-1994 proposed fee rules indicated.the following results if the proposed annual fees were not. modified:
127 .
- Large firms would-gain an unfair competitive advantage over small entities, One commenter noted that a small
'well-logging _ company (a " Mom and_ Pop" type of operation) would find it difficult-to absorb _the-annual fee, while a large corporation would. find it easier.
Another commenter noted that-the fee increase could be more easily absorbed by a high-volume nuclear medicine clinic. A gauge licensee noted that, in the very competitive soils testing market, the annual fees would put it at an extreme disadvantage with its much large-competitors because the proposed fees would be the same for a two-person licensee as for a large firm with thousands of employees. L
- Some firms would be forced to cancel their licenses.
One commenter, with receipts of lers than $500,000 per year, stated that the proposed rule would, in effect, force it to relinquish its soil density gauge and license, thereby reducing its ability to do its work effectively, Another commenter noted that the rule would force the company and many other small businesses to get rid of the materials license altogether. Commenters stated that the proposed rule would result in about 7.0 percent of the well-logging licensees terminating their licenses-immediately and approximately 25 percent terminating their licenses 128
g before the next annual assessment. Some companies would ga out of business. One commenter noted that the proposal would put it, and several other small companies, out of business or, at the very least, make it hard to survive.
- Some companies would have budget problens. Many medical licensees commented that, in these times of slashed reimbursements, the proposed increase of the existing fees and the introduction of additional fees would significantly affect their budgets. Another noted that, in view of the cuts by Medicare and other third party carriers, the fees would produce a hardship and some facilities would experience a great deal of difficulty in meeting this additional burden.
Over the past five years, approximately 2,900 license, approval, and registration terminations have been requested.
-Although some of these terminations were requested because the license was no longer needed or licenses or registrations could be combined, indications are that other termination requests were due to the economic impact of the fees.
TheLNRC continues to receive written and oral' comments from , small materials licensees. These commenters previously indicated i l 129
s-that=the $3.5 million-threshold for small entities was not- . representative-of'small businesses with gross receipts in the thousands of dollars.- These commenters_believe that the $1,800
-maximum annual.-fee represents a relatively high percentage of fgross annual receipts:for these " Mom and Pop" type businesses. ,
Therefore, even the reduced annual fee could have.a significant
-impact.on the ability of these types of businesses to continue to operate.
To alleviate the continuing significant impact of the annual fees on a substantial number of small entities, the NRC considered' alternatives, in accordance with the RFA. These alternatives were evaluated in the FY 1991 rule (56 FR 31472; July-10, 1991) in the FY 1992 rule (57 FR 32691; July 23, 1992), in the _ FY 1993 rule (58 FR 38666; July 20, 1993); in the FY.1994 rule (59 FR 36095; July 20, 1994) and in the FY 1995 rule (60 FR 32218; June 20, 1995). The alternatives considered by the NRC can be summarized as follows. Base fees on some measure of the amount of radioactivity possessed by the licensee (e.g. , number of sources).
- . Base-fees on the frequency-of use of the licensed radioactive material (e.g.,_ volume of patients).
)
130 3
y a
?
3
- 1 Base fees on the NRC size standards for small entities.
'The NRC'has reaxamined the FY 1991-1995 evaluations of the these alternatives. Based on that reexamination, the NRC
= continues to believe that' establishment of a maximum fee for small entities is the most appropriate option to reduce the impact'on small entities.
The NRC established, and is continuing for FY 1996, a maximum annual fee for small entities. The RFA and its
-implementing guidance do not provide specific guidelines on what constitutes _a significant economic impact on a small entity.
'Therefore, the NRC has no benchmark to assist it in determining
, the amount or the percent of gross receipts that should be chnrged to a small entity. For FY 1996, the NRC will rely on the analysis previously completed that established a maximum annual i- fee-for a small entity and the amount of costs that must be recovered _from other.NRC licensees as a result of establishing the maximum annual fees. The NRC continues to believe that the 10 CFR Part 170 license fees (application and amendment), or any adjustments to these licensing fees during the past year, do not have a-significant impact on small_ entities. In issuing this final rule _for FY 1996, the'NRC concludes that the 10 CFR Part 170 materials license fees do not.have.a significant impact on a substantial
-131
i number of small entities and.that the 10'CFR Part 171 maximum annual small entity fee of $1,800 be continued. By maintaining the maximum annual fee for small entities at
$1,800, the annual fee for many small entities is reduced-while i at the same time materials licensees, including small entities, pay for most-of the FY 1996 costs attributable to them. The costs not recovered from small entities are allocated to other materials licensees and to operating power reactors. However, r the amount that must be recovered from other licensees as a result of maintaining the maximum annual fee is not expected to increase. Therefore, the NRC is continuing, for FY 1996, the maximum annual fee (base annual fee plus surcharge) for certain small entities at $1,800 for each fee category covered by each license issued to a small entity.
While reducing the impact on many small entities, the Commission agrees that the maximum annual fee of $1,800 for small entities, when added to-the Part 170 license fees, may continue to have a significant. impact on materials licensees with annual gross receipts in the thousands of dollars. Therefore, as in FY 1992-1995, the NRC is continuing the lower-tier small entity annual fee of $400 for small entities with relatively low gross annual-receipts. The lower-tier small entity fee of $400 also applies to manufacturing. concerns, and educational institutions
.not State or publicly supported, with less than 35 employees.
132 -
o a This lower-tier small entity fee was first established in the final rule published in the Federal Registe': on April 17, 1992 (57 FR 13625) and now includes Lanufacturing companies with a relatively small number of employees. III. Summarv. The NRC has determined the 10 CFR Part 171 annual fees significantly impacts a substantial number of small entities. A maximum fee for small entities strikes a balance between the requirement to collect 100 percent of the NRC budget and the requirtment to consider means of reducing the impact of the fee on small entities. On the basis of its regulatory flexibility analyses, the NRC concludes that a umximum annual fee of $1,800 l for small entities and a lower-tier small entity annual fee of 1 ! $400 for small businesses and not-for-profit organizations with gross annual receipts of less than $350,000, small governmental , I jurisdictions with a population of less than 20,000, small i manuf acturing entities that have less than 35 employees and l educational-institutions that are not State or publicly supported and have less than 35 employees reduces the impact on small entities. At the same time, these reduced annual fees are consistent with the objectives of OBRA-90. Thus, the revised fees for small entities maintain a balance between the objectives of OBRA-90 and the RFA. Therefore, the analysis and conclusions 133
s !
$l
~
established in the FY 1931-1995 rules remain valid for this final :- l rule for FY 1996. e 134
~
Lp oa nseg% UNITED STATES.' g j- NUCLEAR REGULATORY COMMISSION o 8 WASHINGTON. D.C. 30006-0001
**w.* May 2, 1996
/_ihgBonorableLauchFaircloth, Chairman 1 Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety 1 Comittee on Environment and Public Works .
United States Senate 1 Washington, DC 20510
Dear Mr. Chairman:
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its fitness-for-duty rule (10 CFR Part 26), which was published in the Federal Register on-June 7, 1989 (54 FR 24168). NRC's review of experience gained since imalementation of the current rule on January 3,1990, indicated that although the rule is sound and provides a means for deterrence and detection of substance abuse, some modifications to the rule will enhance the effectiveness of licensees' fitness-for-duty programs and reduce unnecessary burdens while assuring continued protection of public health and safety. The proposed amendments take into account experience in implementing the rule, developments in this area, and actions by other Government agencies related to this matter. Enclosed for your information is a copy of the proposed rule as approved by the Commission for publication in the federal Register for public comment. Sincerely, af - Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Proposed Rule cc: -Senator Bob Graham i L l l-
;n'[(:o; ,
.- .[7590-01 P]!
i h NUCLEAR REGULATORY COMMISSION _ 10 CFR Part 26 ' : RIN 3150 AF12
- Modifications to Fitness-For-Duty Program Requirements .
i l AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) p.aposes to amend its .
regulations to modify the current Fitness-For-Duty Program (FFD) requirements. The proposed amendments would apply to all licensees authorized to construct or operate a nuclear power reactor and all licensees authorized to possess or transport Category I nuclear material. The proposed rule.is intended to ensure compatibility with chmges made to the Department of
; Health and Human (HHS) testing guidelines, reduce unnecessary burdens, and ensure
. continued protection of public health and safety. 1 c Itat &M(p o @
s = 1 o l The NRC specifically requests comments on a number of issues and, in particular, as to whether the changes would ptovide a substantial increase in the overall protection of the public health and safety and the common defense and security, whether the rule as whole does
- not constitute a backfit since the rule's cumulative effect is to case licensee burdens or leave them essentially the same, whether those subject to the rule would not object to the nr v reqairements in view of their perception of overall benefit and, if so, whether their non-objection could be grounds for not applying the backfit rule.
DATE: The comment period expires (insert date 90 days from date of publication in the Federal Register). Comments received after thir, date will be considered if it is practical to do so, but the Commission is able to assure consicieration only for comments received on or . before this date. ADDRESSES: Mail comments to: The Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, ATTN: Docketing and Service Branch. Deliver comments to: One White Flint North,11555 Rockville Pike, Rockville, Maryland between 7:30 am and 4:15 pm on Federal workdays. Copies of the draft regulatory analysis, comments received, the Americans With Disabilities Act Technical Assistance Manual, HHS's Medical Review Officer Manual, and NIDA's Technical Advisory of March 11,1991, may be examined at: the NRC Public
- Document Room,2120 L Street, NW. (Lower Level), Washington, DC.
2
Copies of NUREG/CR 5784, " Fitness for Duty in the Nuclear Power Industry: A Review of the First Year of Program Performance and an Update of the Technical Issues," NUREG 1385, " Fitness for Duty in the Nuclear Power Industry: Responses to
. implementation Questions," and NUREG/CR-5758, " Fitness for Duty in the Nuclear Power Industry: Annual Summary of Program Performance Reports," CY 1994, Volume 5, may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328. Copies are also available from the National Technical Information Service,5282 Port Royal Road, Springfield, VA 22161. A copy is available for inspection and/or copying in the NRC Public Document Room,2120 L Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Loren L. Bush, Jr., Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Telephone: (301) 415-2944. SUPPLEMENTARY INFORMATION:
Background
The NRC is proposing to amend its regulations on "Fitners-for Duty Programs," as part of its ongoing activities to improve its regulations. 3
. - - -. - = -. . .
The objective of the licensee's fitness-for-duty program is to provide reawnable assurance that nuclear power plant personnel are reliable, trustworthy, and not under the j
' influence of any substance, legal or illegal, or mentally or physically impaired from any cause, which in any way adversely affects their ability to safely and competently perfonn th duties. Fitness for-duty programs developed under the requirements of 10 CFR Part 26 are intended to create an environment which is free of drugs and the effects of such substances.
In its deliberation of the many issues associated with the rulemaking, the Commission desired that the rde ensure a proper balance between safeguarding individual rights and the Commission's responsibility to protect public health and safety. The changes proposed in this rulemaking are intended to be consistent with the Commissioni dginal goals and to ensure there is a proper balance between the Commission's responsibility for protecting the public health and safety and its interest in protecting individual employee rights from unconstitutional invasi7n of their right to privacy. The NRC has reviewed the experience gained since publication of the rule on June 7, 1989 (54 FR 24468), which was implemented by licensees January 3,1990. NRC review included information from several sources, such as inspections, periodic reports by licensees on program performance, reports of significant FFD events, industry-sponsored meetings, initiatives by the Nuclear M:;aagement and Resources Council (NUMARC) (now the Nuclear
- Energy Institute) and the Substance Abuse and Mental licalth Services Administration -
(SAMHSA)(forn. ly the NationalInstitute on Drug Abuse [NIDA]) and its Drug Testing Advisory Board, and current literature, The review indicates that, although the rule is i 4
fundamentally sound and provides a means for deterrence and detection of substance abuse, some matters need to be addressed. These matters include the - . (1) Need to ensure corrpatibility with changes made to the HHS guidelines;
~
(2) Reduction of burden on licensees while fulfilling the pu' pose of the rule;
. (3) Need for a limited number of new requirements, e.g., to further reduce the d
potential for subversion of the testing process ar to make clear that the appeal process applies to all persons' covered by the rule; and . (4) Need to clarify the Commission's original intent in se.eral areas to reduce incorrect or inconsistent use and differing interpretations end to make a number of administrative changes.- i While none of the proposed amendments represent major changes, they do represent modifications that would substantially reduce the cost of implementation to licensees; enhance overall program integrity, effectiveness, and efficiency; and help to ensure the continued protection of public health and safety. Discussion I The proposed amendments take into account the experience gained in implementing the initial rule, developments in the FFD area, and actions by other Government agencies on drug testing and other FFD concerns. During implementation of new regulations, particularly regulations in rapidly evolving disciplines such as drug testing and employee reliability, a 5
i substantial' number of lessons ar'c learned from' experience. The first five years' of experience 3
- with the NRC's fitness-for duty rule are no' exception. A significant number of the proposed
^
revisions are adjustments to the rule that would decrease the burden on licensees without reducing the protection of public health and safety afforded by the rule. For example, one _ . proposed revision would allow licensees to grant unescorted access to personnel covered by another licensee's FFD program. This would facilitate interchange of employees in, for ; _ example, " peer evaluator" situations. Another prcposed revision of this type would permit licensees to accept generic portions of training provided by anothat licensee to people covered by the rule. This revision would recognize that significant portions of all licensees' fitness-for-duty training cover the same general subjects and would facilitate more timely contractor 1 support during outages. While some proposed revisions would increase program efficiency, others would ensure that the Commission's FFD program more effectively achieves its objectives. - For example, the Commission is proposing several revisions to the rule's drug and alcohol testing requirements that would clarify testing processes and purposes. While many of these rule changes would strengthen testing requirements, others would reduce the testing burden on licensee and contractor employees. These and other revisions would bolster the rule's protection of public safety while reducing the industry's regulatory burden where possible.
-The NRC.is also proposing a substantial number of revisions to respond to legal and-regulatory changes that have occurred since the publication of 10 CFR Part 26. For example, J the Department of Transportation (DOT) and its operating administrations (e.g., the Federal - l Aviation Administration (FAA), the Federal Railroad Administration (FRA), and the Federal _- l i
6
* , e
~'
1 Highway Administration (FHA)) and other Federal and State agencies have expanded their drug and alcohol testing requirements during the past five years. Some of these regulatory ' .,
. changes have created requirements applicable to some licensee employees and contractors that
- duplicate the NRC's drug and alcohol testing requirements. To reduce unnecessarily.
duplicative burdens, the Cominissian is proposing to permit testing performed under these other programs to be accepted in lieu of 10 CFR Part 26 testing when individuals covered by an NRC program are also subject to another propam. Another change since the publication. of 10 CFR Part 26 has been the implementation of the requirements of the Americans with
. Disabilities Act (ADA). While the ADA specifically exempts the NRC's progra.n from certain requirements, various proposed revisions to the regulation accommodate certain aspects of the Act. For example, the current rule requires licensees to determine whether unescorted 4
't access to protected areas and other activities specified in 10 CFR 26.2 have ever been denied to people seeking unescorted access because of substance abuse and related activities. This I section would be revised to limit such inquiry to events that may have occurred during only the previous five years.
During the first years of FFD rule implementation a number of requirements have been found to be ambiguous and therefore subject to inconsistent application by licensees. These ambiguities have been costly to licensees and NRC staff as they have required a substantial number of discussions involving licensee FFD staff, attorneys, and consultants; NRC inspectors; and NRC headquarters staff. Although these ambiguities have already been
. clarified for many licensee programs, the NRC is proposing revisions that would clarify the Commission's intent and help ensure that the regulation is consistently implemented, 7
i 4 inspected, and enforced throughout the industryi increased consistency of rule application throughout the industry will benefit licensees and their employees by reducing the chances of
- arbitrary or' discriminatory application cf the mie.
Finally, there are a number of proposed revisions that would improve the clarity of the: , i rule. For example, several terms regarding the testing process and testing results have been
- more carefully defmed and consistently used to eliminate difficulties in interpretation.
- In considering the actions to be taken, the NRC will continue to consider the proper .7
; balance betweu safeguarding an individual's rights and protecting public health and safety.
p in proposing these FFD rule revisions, the NRC also notes that it is continuing to move toward a performance based regulatory approach in most ofits rule making. Performance-based regulations are intended to give regulated entities clear guidance as to the ! objective of those regulations but not to be overly prescriptive in mandating specific means by , which those entities must achieve the objectives. In taking this approach, the Commission 4 expects to promote efficiencies in nuclear facility operations while maintaining the highest standards of public health and safety. Both NRC policy and Congressional directives emphasize the need for the Commission to move toward performance-based regulation. While some of the proposed FFD rule ravis'ons reflect this performance-based philosophy--most notably the increased licensee discretion incorporated into { 26.80 auditing
- requirements-the somewhat prescriptive nature of the current 10 CFR Part 26 (particularly of Appendix A), and many of the proposed revisions, are a partial departure from that regulatory
- approach.- The NRC islieves that several characteristics of and issues associated with fitness-for-duty programs make it necessary for the Commission to continue to provide detailed 8
w --4
- er s e,r"7s ee --
e _ _ _ _ . _ _ _ _ _ _ _ _ _ _ . _ _ _ _s
r ... . e . c -directives in this particular context. A relatively more specific regulatory approach, for -
- example, will continue to assure that state and local restrictions will not hinder the stringent 1
drug and alcohol testing needed to assure that personnel covered by the rule will continue to ; safely and competently perform their duties, if the NRC's requirements are not clearly stated in the rule,'some state and local laws would prohibit licensees from implementing !e l program elements, thus making complete achievement of the rule's performance objectives. difficult or impossible. The NRC believes that it must maintain the specificity of this rule in - order to clearly preempt such state and local laws that could otherwise apply to licensees' fitness-for duty programs. i The rule's specificity also protects the rights of personnel subject to 'he rule's , mandates Many of the rule's detailed requirements address the need to assu e that testing is performed in a highly reliable manner and that workers are not wrongly accused due to false positive test results. :Many of these details address these concerns and have served to provide high confideace that false positives will not be obtained. While protecting workers against unwarranted damage to their careers in this way, these detailed requirements provide quality controls that also assure accurate, valid, and dependable test results. This, in turn, bolsters FFD progrnm credibility and acceptance among workers. The specific provisions in the rule
. have assured workers who do not abuse drugs or alcohol that FFD program requirements are administered fairly and competently and that their fellow workers who do violate FFD policy
~ will likely be detected and removed from duty.- e The rule's specificity has also benefited licensees during the first five years of the l rule's implementation. This specificity has, for example, helped assure that positive test 9 e
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. . ~ ;
- rer.ncan be more easily defended when challe ged in court and'during unemployment .l proceedings. They have also provided a clear stateinent of the NRC's position for licensees
. and labor representatives to use when negotiating FFD related issues in collective bargaining -
agreements. The introduction of drug testing and related fitness-for-duty program requirements into the workplace is a mandatory issue for collective bargaining under_the National Labor Relations Act. A prescriptive fitness for-duty rule enables licensees and labor , ieysaatatives to more effectively achieve the NRC's program objectives by clearly showing-i that the' NRC requires particular program elements to be implemented in specific ways. Like the NRC, other Federal and state agencies have also found it necessary to i establish specific requirements rather than adopt a more performance-based approach to assuring worker fitness. For example, the detailed nature of the NRC's FFD rule is matched l by the drug use and alcohol abuse prevention rules promulgated by the DOT and its five l , operating administrations. The level of detail of the HHS require:nents for the testing of Federal workers is also comparable to that provided by Fart 26. The experience of these 4 agencies bears out the need for relatively specific regulations in this workplace fitness context. The NRC seeks public comment on the following issues. Public comments should be submitted to the NRC as indicated under the heading Addresses.
- 1. :Would any of the proposed changes, group of related requirements (e.g.,
modifications to prevent subversion of the testing process, further ensure the accuracy and integrity of testing,' clarify actions for removal), or the rulemaking as a whole provide a - substantial increase _in the overall protection of the public health and safety or the common-10-1 l----------_n ,n. .,. . .-- ~ , - - , -e, , w. ,
- defense and security? Are the groupings and subgroupings of the changes contained in the--
Backlit Analysis section of this Federal Register notice appropriate and are the changes categorized properly? Are the changes in Group Ill worthwhile and necessary to better-
- accomplish the FFD rule's objective, clarify the rule's existing requirements, and reduce cmbiguities. Does the rule as a whole not constitute a backfit since the ruWs cumulative.
effect is to ease licensee burdens or leave them essentially the same,' rather thari to increase them. Does anyone subject to the rule not object to the new requirements in view of their perception of an overall benefit and, if so, would their non-objection be grounds for not applying the ba:kfit rule? Although the NRC believes that the proposed specific changes to the fitness-for-du:y rule (FFD)'would be the most efficient method of accomplishing the regulatory objectives of the changes, are there any viable alternative approaches that should be considered, particularly with respect to the proposed changes in Group Ill B7 Could the rule
- be less specific in stating the requirements? The staffs analysis of alternative approaches j
such as development of a Regulatory Guide, NUREG good practices, meetings with licensees, or industry initiatives, is contained in the draft Regulatory Analysis.
- 2. Should the NRC revise Appendix A to 10 CFR Part 26 to incorporate revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs recently adopted by
.the Departmut of Health and Human Services (HHS) (June 9,1994; 59 FR 29908)? The L
Commission proposes adoption of the changes to the HHS guidelines. In most instances, the L L HHS guidelines have been adopted as published by HHS; however, in some cases modifications are proposed to allow compatibility within the framework of the original FFD p jg .
- . . . . , . . - . . - - .# 1, ,. i - _G _
's rule (e.g.. on site testing provisions dictated differences in minimum specimen volume,
- minimum number of blind performance specimens, on-site determination of the validity of specimens), The NRC' desires to be consistent with the HHS Guidelines, absent a compelling _
~ reason why a departure is necessary.
- 3. With respect to the discussion of the proposed changes to j 26.24, are there any altemative techniques for testing for alcohol that should be considered for adoption by the W NRC7
- 4. During the past five years of program operations, several parties have recommended that the NRC consider obtaining certain types ofinformation in addition to that currently required to be submitted under the provisions of f 26.71 (d). They believe that the Commission could use such information to better manage its FFD program oversight responsibilities, which includes formulation of public po: icy. The specific additional types of information and their potential use by the NRC are described in the discussion of proposed revisions to i 26.71 but are not incorporated into the proposed changes to the text of the rule.
The NRC requests public comment on whether the licensees should be required to collect, analyze, and submit to the NRC such additional types ofinformation.
- 5. The NRC is proposing to' add a new Section 2.7 (e) to Appendix A that would require testing to determine specimen validity (i.e., detect evidence of adulteration or dilution) before performing a screening test on site (if appropriate) and at the HHS laboratory. This 12 i
-. ' 1, .
'i
' would be an adaptation of a change HHS made to its guidelines inJune,1994. However, not l all dilute specimens are the result of attemptr to avoid' detection. Hence, to minimize the j
probability .of incorrect conclusions from such events, suspect specimens, including those with
~
abnormal specific gravity (SG) would be subject to screening and confirmation testing using _ _l the limit of detection that the laboratory is' capable of performing. The Commission requests comments regarding this change, and, in addition, requests comments on three other revisions to detect evidence of adulterat i on or dilution th;.: . ire under consideration:-
- s. Including Ph and/or creatinine as well as SG in the requir.d testing to detcrmine spec men validity; ,
- b. Requiring tests to determine specimen validity (which might include SG, Ph,- ,
and/or creatinine) immediately after specimen collection at all sites and immediv.e collection of a second specimen from those individu4s providing specimens with abnormal qualities; and
- c. Requiring tests at one half of the cut-offlevels specified for each drug instead of at the HHS cenified laboratory's limit of detection for suspect specimens.
- 6. With respect to the discussion of the preposed changes to 0 ction 2.7 of Appendix-A:
a; Should the NRC require tests for agents that can be added to urine as an attempt to mask THC (marijuana) or other drugs?
- b. ? Should the NRC raise the cutofflevels for screening and confirmation tests for j opiates to reduce the laboratory-confirmed positives for opiates that the medical -
J 33 I
l review officer (MRO) determines to be negative? Given the high level of concern for safety in the nuclear industry, should the NRC retain the current levelt even if HHS should raise the levels for " demand reduction" programs covered by its i Guidelines as it proposed on November 16,1995 (60 FR 57587). I
- 7. . A key element of assuring the integrity of the testing program is the continued assurance of test accuracy through licensees' submission of blind performance test specimens to HHS-certified Ir~ sratories as required by Section 2.8 (e) of Appendix A. The NRC has received a number of suggestions regarding improving these blind performance test specimen requirements. The Commission is considering each of these suggested revisions and invites public comment on the following:
- a. A limited HHS survey of blind performance test specimens supplied by various ,
vendors has indicated a wide range of drug or metabolite concentrations in spiked specimens. Should the NRC require licensees to assure that concentration ranges for blind perfonnance test specimens be within a defined range (to be determined in consultation with HHS)?
- b. Should the NRC require that providers of performance test specimens be separate and independent (no conflict of interest) from those performing the specimen collection, specimen testing, MRO, and auditing functions?
- 8. The NRC has received requests from several licensees and vendors to permit the
- on-site use of non-instrumented, qualitative immunoassay methods that involve the use of 14
- ,. - . - . . . _- . _ . - - _ -.-. .. - . .-. - - - - . ~
7, i q :- Inexpensive, disposable devices. :As discussed in more detail under the proposed changes to
-Section 2.7 of Appendix A, these screening techniques have not been validated to achieve.the high levels ot' specificity and accuracy that are needed in FFD programs.: Of concern to the-
. Commission is that these devices may pro 6uce an unacceptably high number of false negative:
test results and may be easily subverted. The Commission invites public comment on the - advisability 'of creating guidelines, quahty' assurance procedures, and performance standards to q
. govern use of these devi ces. Al ternativel y, should the Commission prohibit the use of these l devices until such time as HHS (or another agency) has developed guidelines, procedures, and- 1 standards. Should there be a Conforming Products List for these devices similar to that published by the National Highway Traffic Safety Administration (NHTSA) for evidential breath measurement devices? Who should administer such a program?
Grouns of interrelated revisions. .; Several of the proposed rule changes should be considered as groups ofinterrelated revisions that, if adopted, will interact with each other and with the current rule to accomplish important FFD objectives. Foremost among these are several revisions intended to minimize subversion of the testing process. - Subversion has proven to be a continuing problem that threatens the effectiveness of workplace testing programs across the country. ~ Although a-- number of wchniques for subverti. g the testing process exist, flushing (diluting the specimen by drinking :opious amounts of water) appears to be the most common. . The proposed rule is intended to reduce the potential for successful subversion by flushing include (1) a 15' u m.. .2 -
requirement that licensees minimize the time between notification of the person to repo random test and the collection of the specimen and (2) a requirement to determine the validity 9 of specimens, which would be done through testing for specific gravity _(SG) and may i i several other methods.- Other forms of subversion include the adulteration of specimens and - the submission of surrogate specimens. Reducing the time between nodfication and testing-will also counter these subversion techniques. To further reduce the potential for subversion, the NRC propcses using a narrower temperature range than set by the HHS guidelines for determining an acceptable specimen. This would make it more difficult to submit surrogate specimens and to use some dilution techniques. The proposed rule also would revise vario l sections to state more clearly that any act or attempted act of subversion is to be considered a violation of FFD policy. These revisions would provide an integ.aed response to the problem l. of subversion. The Commission also is proposing to require that dilute and other questionable specimens be tested at the lowest level of detection (LOD) that the laboratory is qualified to use. While this revision would have an anti su'oversion effect, its primary purpose would be to further protect those being tested. Currently, when a testing laboratory determines that a specimen is' dilute or otherwise of questionable qurlity, the person tested is required to produce a second specimen under the direct observation of a collection site person. Test i results indicate, however, that a great majority of dilute specimens result from reasons other p - than drug use. Requiring level of detection testing would infringe less on the individual's privacy by minimizing the neej to produce a second specimen under direct observation.- It would protect those being tes'ed also by providing MRos veith additional useful informa: ion 16 L ,
-_ g n - . . ~ . . _ - - - -- - - - . - - . . - . . - . - - -
g .: g e to enable them to make accurate determinations of whether a specimen of questionable' r Jvalidity has actpally been adulterated or diluted. lThe preposed revisions pertaining to removal from unescorted access because of FFD policy viola'aon and' subsequent return to work constitute a second important group of 1 ' interrelated revisions. One revision woald clarify the Commission's original intent that any ' violation of a licensee's FFD policy must result in immediate removal from unescorted access ; s status upon determination of a violation. Before ,a person is allowed to retum to work, the - condition that led to removal would have to be resolved through a medical determination of.
~
i, fitness conducted by appropriately qualified personnel and the person would have to be tested under a proposed retum to-duty testing requirement. Another related revision would clarify the _ Commission's intent that persons to whom unescorted access is reinstated after a policy violation are to be subject to follow-up testing for a three-year period.~ These sad other proposed changes are intended to provide a more complete set of requirements relating to removals and retuni to duty. , The NRC is also proposing a set of revisions that would address situations in which n individuals subject to the rule's testing requirements are only infrequently on site. Although most licensees have appropriate provisions in this area, several licensees have gone to great expense in bringing off site workers to the collection facility for testing immediately upon their being chosen from 'the random testing pool. Some off-site workers have been required j _ to drive 2-4 hours each way, fly cross country, and/or stay overnight: Some licensees use
- - mobile collection facilities or teams to travel to the location of the person selected for testing.
One proposed revision would make clear the NRC's original intent that people need not be - 17
_ . _ . ._ . .~ __ . _ _ _ _ . _ . . _ . . _ _ _ _ _ . _ _ s .: (_ $'[ 1 immediately brought to the site for testing in'such situations. Another related revision would:
- eliminate the requirement for a suitable' inquiry into a person's' employment status when the person returns to a site a6er having not been covered by an FFD program for thirty days or less. This revision would also clarify the requirements applicable to indisiduals who come to l
the site only infrequently. A fourth group of revisions relates to testing for alcohol. Impairment caused by - ! alcohol raisuse creates a safety risk that is fundamentally similar to the risk posed by the. misuse of illegal drugs. Some licensees, however, have imposed lesser sanctions for alcohol violations, an approach that is contrary to the Commission's intent. The NRC proposes to - rectify this situation by explicitly requiring the same minimum sanctions for abuse of alcohol t as currently exist for use of illegal drugs. Several proposed revisions would contribute to this objective. One revision would explicitly define the FFD policy violations involving alcohol. . Likewise, alcohol test results between 0.02 and 0.04 percent would be forwarded to the Medical Review OfYicer (MRO) for back calculatian to determine whether the person had an impermissibly high blood alcohol content while on duty. The requirements concerning conduct of suitable inquiries would also be revised to explicitly require that licensees y
- determine whether persons seeking unescon.xf access status have ever used alcohol in a manner that resulted in on-duty impairment.
A fifth group of proposed revisions would address current ambiguities associated with the testing for the use of amphetamines. The studard for confirmatory testing for methamphetamines would be supplemented with the requirement that specimens must also - . contain a specific amount of amphetamine to be confirmed as positive. Multiple screening 18
. : ; ce u tests would b ' e permitted to reduce the amphetamine testing problems caused by crou reactivity.J A requirement that specimens confirmed positive for amphetamines must also be tested for d and I isomers is another related proposed revision. __ Another proposed revision
- would allow an extra two days for HHS-certified laboratories to report to licensees test results having suspected amphetamines. These revisions would serve to' clarify and rationalize testing?
requirements for amphetamines.
., .i Use of old test results.
. t
- , The NRC also cautions licensees that test results obtained before January 3,1990, should be considered with great care. The results may be questionable for the following l
reasons: 1
- The HHS laboratory certification program was initiated in 1988 and by the end of 1989 about 40 laboratories were certified. - Many of the laboratories.being used did not meet current performance standards for accuracy and reliability.
i >
- In some cases, confirmation term may not have been conducted.
= In many cases, there was no review by a technically qualified person, such as a n
. MRO, to determine if legitimate uses of drugs (particularly amphetamines and opiates) _were causing the results reported by the laboratories.
- The NRC staff has been informed of several cases in_which persons alleged they had a record of a questionably positive drug test 5 to 15 years ago, have since worked in the ::uclear industry with a good work record and no positive drug tests, and are now deni:d employment.
i e g
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. c. , ;
' y :' L The Commimon recognizes that positive drug test results obtained before the rule was implemenh may indicate persons who have a significant past history of drug ' abuse but, because of the factors noted above, other available information should also be considered. .
1 Descrintion of nronosed channes by section. 4 The following discussion describes the changes to the current FFD rule that are being . proposed and the reasons for the changes. Section 26.2' Scone. The NRC proposes to amend this section to include specified classes of personnel who administer testing programs. Although Section 2.3 of Appendix A requires that licensees carefully select and monitor persons responsible for administering the testing program based upon the highest standards of honesty and integrity, some licensees' testing programs have not included all persons originally intended to be tested. This action is taken to clarify the Commission's original intent because although the<e people normally work outside the protected area, their actiont do have an ongoing effect on safety and would have an impact on the confidence of management and the workforce in the integrity of the program and the reliability of the results. Persons who administer testing programs are in a position to perm it
- substance abusers to remain tmdetected. The persons who administer the tests could
- inadvertently omit testing of an employee as a result ofimpaired behavior on the part of the 20~
.- ., w i . f.,
test administrator because of substance abuse or intentionally because of motives associated I: with substance abuse, empathy with the abuser, etc.- Furthermore, the omission of test - administrators from testing and other program requirements tends to undermine the_ credibility. oflicensees' FFD progran.s.
- Several reported incidents have confirmed the need to assure that FFD program personnel meet the highest standards of honesty, integrity, reliability, and trustworthiness. For - q example, one licensee added collection personnc! .a the testing pool after investigation of an
' allegation determined that two specimen collectors were substance abusers. In another instance, a contracted MRO not in the testing pool was reported to be an alcoholic and an abuser of prescription drugs, t
The proposed revision to i 26.2 (a) would fulfill the NRC's original objective for this section and require all licensees to extend the coverage of their programs to the following
- three classes of FFD personnel:
- --* Personnel who can link test results with the person who was tested; f
- Personnel making removal and return-to-work recommendations or decisions; and 2
- Personnel involved in the selection and notification of employees for testing and the
- col'ection of specimens.
Specimen collectors, the MRO, the FFD program manager, Employee Assistance Program (EAP) counselors, and other selected' administrative staff would be examples of FFD program personnel .who would be included within this clarification of the rule's scope, t Testing of FFD personnel is further discussed in conjunction with Section 2.3 of Appendix A. 4 t p 21 f
. . .-u- - . . . . . s .. . . .- - - - , .- -- .-, - . . . , , - - - .
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The NRC also proposes to amend i 26.2 to' allow reduced scope programs for facilities L that are in the process of being decommissioned. Because the level of risk associated with - these facilities will decline during decommissioningithe revision is designed to provide the NRC with the flexibility to tailor the FFD pogram to site-specific factors as' deemed- j sppropriate by the NRC to protect public health and safety. Finally, the NRC proposes to amend i 26.2 to provide that people covered by a - j program regultted by another Federal or state ageacy that meets the general performance - objectives of the FFD rute need not be additionally covered by a licensee's FFD program. Duplicate testin: and training requirements applicable to an appreciable number of individuals working et nuclear facilities have become an increasing problem as the Department of Transportation's drug testing requirements and new alcohol testing rule have been r implemented. Differences in specific program requirements, such as the use of different cut-off levels (but which are at least as stringent as the HHE guidelines), would be unlikely to have a significant effect on the licensee's FFD program in meeting the general performance objectives. The licensee would continue to be responsible for behavioral obsen>ation, immediate removal from duty of pt...ons_ whose fitness may be questionable, and for-cause - testing for a specific situation. This' revision would reduce the burden on individuals covered by multiple Federal and State programs with requirements that_ duplicate the FFD rule. L 4 t 9 L 22
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- - . - - - = - - -.- ,-.- -,- - -- .. . . . . ._._ - - - - ._- .
- ~.j 7
t Section 26.3 Definitions.
-i The NRC proposes that this .iection.be modified to clarify definitions of some terms,- :
- to enake terms and definitions raore consistent with those tr.ed by other Federal agencies -l (including the Substance Abu'e and Mental Health Senices Administration and the Department of Transportation), to provide new definitions to support other sections of the rule, and to remove three terms, " random test," _ fallow-up testing," and " suitable inquiry,"
because they are already fully defined in the text of the rule In addition, several teems have been utaved to this section from Section 1.2 of Appendix A because they first appear in the , main body of the rule. For the most part, changes in this section are intended to eliminate differing-interpretations and ambiguitie: in current wording. The Commission proposes three changes l to the terms used for definitions of drug test results. The changes include modification to the l definition of " confirmed positive test" to reflect proposed changes to terms and definitions, , and the addition of the terms " laboratory confirmed positive" and " unconfirmed positive test result." " Laboratory confirmed positive" would refer to the positive outcome of a gas chromatography / mass spectrometry (GC/MS) test. These tests are reviewed by the MRO to determine if they show a violation of the FFD policy or if there is a medical explanation for i l the positive result. " Unconfirmed positive test result" would refer to the result of a screening test that is not negative. The original wording of the rule refers to these results in a number of ways, most often as " presumptive positives." The term " presumptive positive" and other terms used to refer to this result have been replaced with " unconfirmed positive test result"
-23
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il I throughout the rule to increase clarity.and consistency. The definition of" confirmatory test"
- would be revised to reflect a proposed revision made elsewhere in the rule relating to blood j tests for alcohol that could be used in an appeal. The term " screening test" would replace the former terms " initial or screening test" in the interests of clarity.
The NRC proposes to add a definition of" medical determination of fitness" to support
- proposed changes to other sections of the regulatio's. This te m would clarify the role of the MRO or other licensed physician in determLi.g 11tness for duty and provide a standard regarding what constitutes this determination. The focus of the medical deter nination would t
be to determine if a rule or policy vio!ation has occurred and to evaluate the potential for. on duty impairment (e.g., of sensory, cognitive, motor and communicative skills) that would
-interfere with the safe performance of the individual's duties.
A new definition of " behavioral observation" is proposed that would clarify the role of ( o supervisors in monitoring the behavior of workers under their oversight. It is the NRC's . intent that all personnel having unescorted access to the protected area be subject to behavioral observation. To accomplish this goal, supervisors are expected to observe the behavior of all personnel with whom they have routine contact, not only those workers for r .whom they ave h direct supervisory responsibi!!ty. Licensees would, for example, be responsible for ensuring that contractor employees whose supervisors may remain off site be subject to behavioral oversight by licensee supervisory personnel when within the protected - area The contractor employees would, however, still be subject to behavioral observation by their own supervisors when off site. A definition for " supervisor" is proposed to clarify that
- 24
01 . , --, - J l i supervisors include all personnel with supervisory responsibilities over workers with
; unescorted access, whethe they are on site or off sia.
- The NRC proposes to add the terms " abuse oflegal drugs" and " substance abuse" and '
definitions for these terms to clarify the intent of the rule and to support changes to d management actions and sanctions regarding alcohol and other legal drugs and substance I
- 4 abuse.
The NRC proposes to vJd the term "subvt.rsion" and to define it in terms of the 7 intentional causing of a missing or inaccurate drug or alcohol test result at any stage of the testing program, including the process of selection and notification, specimen collection, [ specimen analysis, testing, and reporting of test results. l Finally, the NRC proposes that the definition of " aliquot" be modified by adding
- language designed to make it clearer that the aliquot is a representative sample of a specimen -
and can be used for retesting, t Section 26.7 Communications.
- A new section, " Communications," similar to existing sections in other 10 CFR Parts would be added to ensure that communications with the NRC are processed properly.
Section 26.8 - Information collection reauirements: OMB anoroval. f
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o . The NRC proposes to delete 6 26.8 (c) which presents an estimate of the total time burden for this Part's recordkeeping requirements and solleits licensee comments concerning the accuracy of the estimate and ways by which the burden can be reduced. This information is not normally codified in the regulations and is being deleted to maintain consistency with other parts throughout 10 CFR Chapter I. Burden estimates and requests for public comments on the burden estimates continue to be published in the preamble of Federal Register Notices for NRC rulemaking in accordance with Office of Management and Budget (OMB) 4 regulations. Section 26.20 Written ooliev and erocedures. The NRC proposes several changes to this section. One amendment would make it clear that licensees' overall description of th:lr policy on FFD must be prepared in a summary form, which .nost licensees have done, and made readily available to employees covered by the rule [6 26.20 (a)). It has been noted during inspections that a few licensees had ; incorporated thdr FFD policy into the several procedures that were not readily available to employees. The NRC's intent remains that licensees publish a statement notifying employees of the policy as is required by the Drug Free Workplace Act of 1988. Other amendments would cluify f 26.20 (4) and (d) to ensure that a licensee's FFD policy addresses employees' off site involvement with illegal drugs, the abuse of legal drugs, the subversion of the testing process by adulterating or substituting specimens, the refusal to provide a ipecimen, and use of prescription and over the counter medications that may cause , 26
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impairment. This revision would make explicit the need to address FFD concerns that have emerged during the first five years of program operation. Another amendment would clarify the requirements pertaining to licensees' procedures to ensure that persons called in to perform an unschedu!cd working tour are St to perfonn the task assigned f f 26.20 (c)]. This section currently requires called in employees to state whether they have consumed alcohol witnin the licensee's pre-duty abstinence period. The proposed revision would make it clear that this declaration of fitness includes fitness to perform tasks assigned, not just alcohol consumption. These revisions would afford employees an added safeguard in that they would have an opportunity to express their own opinion as to whether they believe themselves fit in view of fatigue, ill.iess, use cf medict. ion or consumption of alcohol to perform assigned tasks. This requirement would also enable licensees to obtain the iriformation over the telephone to avoid having to get that person safely home after arriving on site unfit to work, call in another person, and avoid the potential for civil law suits that could arise from accidents while the ca!!ed in person is in travel. Another amendment would remove the statement that the Commission may review the licensee's FFD policy and procedures at any time [{ 26.20 (0]. This provision is unnecessary because the Commission may always inspect the l'censee's program. A new f 26.20 (0 would add a paragraph that would allow licensees to credit i unescorted access status granted by other licensees. Such individuals must be covered by the . random testing and behavioral observation programs of either the original licensee employer or that of the host licensee. This change would facilitate the interchange of personnel among licensees in. for example, situations where a " peer evaluator" frot . one licensee works with a l 27
_ _ _ - ~ . _ . _ _ _ _ _ _. . _. _..___ ._ e .
. o i
second licensee (e.g., inspections conducted under the auspices of the Institute of Nuclear i Power Operations (INPO)). It clarifies that there is no need for a licensee to audit another licensee's program before granting unescorted access to that licensee's employee. The NRC continues to believe that an sostinence period of at least 5 hourt preceding l i t l any scheduled working tour is appropriate and wishes to clarify the implications of this i abstention period for employees. This requirement continues to accommodate a reasonable and moderate amount of off-duty alcohol consumption outside the abstention period. l Employees isors complete their training either before or very soon after they assume their duties. Although the NRC considered amending the rule to clarify requirements concerning situations in which contractor, and possibly some licensee, supervisors do not have unescorted access privileges themselves but supervise people who do have such privileges, it believes the following guidance should sumee. The NRC expects that those supervisors who do not come on site would be trained in drug recognition, behavioral observation, and procedures for initiating corrective action. The NRC also expects that, while on site, these workers are observed by someone trained in these matters. The NRC is concerned that some licensees may have appointed people as " acting" supervisors for periods ofle s than three months ar.d have given these people none of the programmatie training required by this section. The NRC believes that even " acting" supervisors must be trained in the five topics appearing in { 26.22 (a) as soon as feasible. The NRC is also proposing to allow a written examination that demonstrates t.n adequate knowledge of pertinent FFD issues and material to be used in lieu of refresher training for supervisors and escorts in two out of every three years. Allowing the use of a 30
l j 5
*& exam would increase flexibility without compromising the integrity of FFD programs ,
I L ed & :'ecrease administrative expenses. The NRC has declined to change the nominal 12-month frequency associated with this refresher training for supenisors and escorts as it ; l i Proposes to do for the policy communications and awareness training required by i 26.21 (b ! Supervisors and escorts must, for example, he able to recognia drug use or degradation of j performance of the people working around them. Having training, or a written examination in lieu of training, at an interval of mere than 12 n.onths may not be suflicient to ensure that I supervisors and escorts would remain diligent and effective in performing these fimetions. l Another proposed amendment would allow licensees to accept the training of people who have been subject to a Part 26 program at another site and have had initial or refresher
- training (or testing in lieu of refresher training) wi hin t 12 months before assignment to
- superviso_ry duties. This proposed revision would facilitate the movement of supenisory i personnel among licensees and decrease licensee costs for training individuals in a numbe.* of common areas that are consistent across licensee programs. As noted previously, because there are some differences among licensees, new employees should be trained in those aspects of the licensee's program that are site specific. 6 As noted by the Commission's regulatory review group, behavioral observation training as described in i 26.22 (a) should not focus solely on substance abuse. 'nstead, it should also provide managers and supervisors training in appropriate actions to take (e.g., referral to EAP) when individuals have FFD problems other than substance abuse that affect them (e.g., stnss, fatigue). i
+
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_ _ __ _ _= _ ._ _. _ _ . _ _ . _ . __ _ j a i Saetion 26.23 Contractors and Vandars.
-i ,
This section currently requires that personnel who have been denied av..a or removed from activities within the scope of Part 26 for violations of an FFD policy will not be . assigned to activities within the scope of Part 26 without the knowledge and consent of the licensee. During the first five years of FFD program operations instances occurred in which personnel with a history of substance abuse known to the contractor employer were sent on site without the licensee being informed of such history. Therefore, this section is xvised to t make clear that persons with a known (to the contractor or vendor) history of substance abuse must not receive these assignments without the knowledge and consent of the licensee. The NRC understands that some contractors have requested escorted accen for individuals with a drug history in order to avoid informing the licensee. The Commission 1 j Jesires comments as to whether the rule should be revised so that this practice is no longer permitted. t i
. . Section 26.24 Chemical Testino.
The NRC proposes to revise the descriptions of the four types of testing that are currently required. The proposed changes are intended to rectify inconsistent interpretations of testing requirements that have appeared across the industry during the five years of FFD program operations. In { 26.24 (a) (1), chemical testing before granting unescorted access would be referred to as "preaccess testing." It continues to be the NRC's intention that any 32 .
test, whether before or after the beginning of a person's term of employment with the licensee, that is perfonned with the intent that it may be a test as required by i 26.24 (a) (1) must meet the standards set forth in Part 26 and be reported to the NRC as a preaccess test. t One proponed amendment to this paragraph designed to rWuce unnecessarily redundant testing _ i, . l of applicants for acceu privileges, would allow licensees to consider any drug and alcohol test I
; meeting Part 26 standards and perfonned within 60 usys before the granting of unescorted
- access to serve as a preaccess test. A test performad by another licensee or under a testing program required by the U.S. Department of Transportation are examples of tests that would qualify as preocceu tests under this proposed revision. In such circumstances, the NRC
\ would expect that licensees would use a dependable means of confirming that the person - ! seeking access had actually bee.n tested.- This could be accomplished by the electronic l - exchange of pertinent information among licensees using a computerized data base that the industry is currently considering for implementation. As another clarification of the NRC's original intent, as described in item number 4.5 of NUREG 1385, "FFD in the Nuclear Power Industry. Responses to I:nplementation Questions, { 26.24 (a) (1) would be amended to explicitly prohibit the granting of unescorted access unti! the person's negative preaccess test resu!t has been obtained. However, another change.would allow some relief from thk requirement. Unescorted access could be granted before receipt of a negative test restk e person seeking accen has no history indicating the use ofillegal drugs or the abuse oflegal drugs and has either had a negative result on a test meeting Part 26 standards performed within six months before the granting of unescorted , access or been covered by a program meeting Part 26 standards for two consecutive weeks 33-s
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during that six month period. this relief from the requirement to obtain a negative test result before the granting of access is, based upon industry experience of the demonstrated reliability l of workers who have been covered by a rigorous program in the past. In these circumstances, j the NRC expects that licensees would confirm the occurrence of such tests or such coverage. These proposed revisions are intended to reiterate the importance attached to establishing an f Individuals' fitness status before unescorted accen is granted. At the same time, these i revisions would allow some efficiencies borne out by industry experience in the granting of , access without compromising public health and safety. Some additional relief would bc : provided where the individual is transferring from another licensee. In this case, if the _ l t individual has been covered by an FFD program for 30 of the previous 60 days, no specimen need be collected and tested. Other propond changes to this section (( 26.24 (a)(2)] would more clearly describe the full meaning of the currently required attributes of random testing. Some licensees who randomly tested only during weekday day shifts previded predictable gaps in testing. People working during evenings and on weekends knew they would not be tested. Workers who were randomly selected for testing, but did not happen to be on site at the time scheduled for specimen collection because they normally worked off site or worked a night or weekend 3 shift, were deleted from the list of people to be tested that day and other workers who were present substituted in their place.' Thus, not all workers had an equal chance of being tested. All testing personnel and employees must be made aware that tests are truly_ random and unpredictable, and therefore that unannounced tests may occur during any day or night duty hours. Predictable patterns of random testing are prohibited by the rule. The proposed rule ! 34 9 y - - 9-.--> - - - . - , - , - + - -y a-me- g e. -e w ,, w------,,ry-c, y---m--+ *,ww,+w.-wwww.w-,-w,-,, woe- w w
Q , 0 changes would create no new random testing requirements, but would instead clarify currently existing requirements that random testing be unpredictable and conducted at various times during the day. As discussed in item number 4.6 of NUREG 1385, which points out that lillS's " Medical Review Officer Manual" suggests that random sampling procedures should permit no " safe periods" for any employce: "Each work day should present each employee with a new opportunity of having to produce a semple . . . ." A ;vovision would be added to clarify that reasonable efforts must he made in test persons selected for random testing. For persons off site and within n n ssonabk tweling time and distance, the NRC expects collection of specimens be completed as prornptly as notification and travel can be accomplished. For other rcrson:- H mt M . af.uo n~,ing
' ', ud "" la the NRC expects that upon their return to the site the. h r. op : #
the provisions of 6 26.24 (a) (2) and that the test would 1,e ,en "b o e on ' >m s. A proposed amendment would provide flexibility to condu.t for cametets 4 '6.?4 (a) (3)) no more than 2 hours for the alcohol part of U.c h.u m a ...,n .s. .~ .to., e u oi the test following an indicated need for testing. This cinn.ip i, suo e.!e - .""mo"Me situations where no collection personnel are on site and need to : e s.nled m -. e in* .luar needs to be transported to another location for testing While it is 4, th, best intmsts of huh the licensec and the worker in this situation to collect the spedu.cna an >o4. rov.ibic,as currently required, more flexibility is appropriate. A shoater tims is >peciikd f ar alcohol because of the more rapid metabolism of this substance. Other additions to this section would be clarification of the conditions that initiate a for-cause test and clarification that an MRO or other licensed medical person must determine 35
i I the fitness for duty of an individual tested for cause before that worker may retum to duty. l
- Although the NRC considered amending the rule if to clar i y requ rements concerning situatio l I
in which a worker may be potentially impaired from causes that would not be detectable by . ,
. drug and alcohol testing, it believes the following guidance should suffice. Although - :
t impalement caused by factors other than substance abuse is usually not a violation of the! rule by the worker, it is the responsibility of the licensee to assure that no impairment, J regardless of cause, threatens public safety. l The NRC has received, but declined to adopt, recommendations that this section bc ; revised to authorire licensees to administer an " alcohol only" test in censin situations. Under - this recommendation, only a breath test would be required when conditions that directly i indicate alcohol use, such as alcohol on the breath, create a reasonable suspicion that the ; person may have misused alcohol in violation of the licensee's fitness for-duty policy. The NRC believes that allowing an alcohol only test in these circumstances would be inappropriate. It is preferable to perform both an alcohol test and a drug test, whether the alcohol test is positive or negative, to fully investigate the individual's fitness for duty. However, if the alcohol test is negative and the individual is determined fit by a designated licensee representative qualified to make the detem instion, the individual could be retumed to duty pending laboratory testing of the urine specimen and receipt of urinalysis results. The I
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9 I 36
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Commission believes that this provides an appropriate balance between assurance ola thorough inquiry and determination of 6tness and reduction of the impacts caused by time away from the work station. The requirements pertaining to follow up testing (j 26.24 (a)(4)) would be clarified by incorporating the provisions of ( 26.27 (b) (4) to make explicit that all people to whom unescorted access is reinstated under { 26.27 (b) must be subject to unannounced and unpredictable testing for at least three years folk c.:ng reinstatement. The duration of l rollowi.o tisiing is supported by rese,uch which indicates that chronic abusers of alcohol and othe: drugs usually need several years to recover from their habits. Under these proposed imen hi.cru, lin niec:; would be runoised to iilopt a prograra that is tailored to the odio . medical Ww, and th~ rnrvr< ik miniinom trquirements. These amenilments re ii o " led to clarifj the utiient ui ditiec, an6 < which licensees c,ui n instate unescorted aceew loflowing a Orst or second violation of an FFD policy. A proposed requirement that
.he i. .n..n he inne rcisi4ste . .WJul h, sonfunn the followup te> ting to the existing equo co e!'. for s nidoen testing.
I he NRC pnipo_ses to add .i lilth type of required chemical testing referred to as
'retnin to duty" testing (s 26.24 (a)(5)). In its current form, the rule does not clearly state
.ne ce naa>> ion's intent that ikcasec.s .ss ould test personnel haung nuescorted access when 6 hey return to work after extended absences. The NRC staff is aware that most, but not all, licensees are already testing people when they return to their sites after extended absences.
The proposed new { 26.24 (a)(5) would require return-to-duty testing when workers seek to regain unescorted access to protected areas in two types of circumstances. First, workers 37
seeking to regain unescorted access afier having be:.. denied access under the provisions of f
~
i
- 26.27 (b) would be tested and a negative result obtained before access is restored. Second. a l
worker who seeks to regain acceu at a particular licensee's plant after an absence _from the 1 i possibility of being tested under that licensee's FFD program for more than 60 days would 1 I have to be tested under this requirement. Provisions are made in the rule to lessen the impact. This proposed revision is also intended to clarify expectations regarding individuals selected for random testing who are away from the site and not available for testing. The NRC staff understands that some licensees are currently calling people in for random tests from long i distances (e.g., a 2. to 4 hour drive each way, cross-country flights, overnight stays). Some licensees use mobile collection facilities or teams to travel to the persons selected for testing. I The NRC staff is also aware that many licensees are routinely testing people such as utility headquarters staff, contractors, and consultants who come to the site only infrequently but
~ '
may have access status. The new retum to duty testing requirements and the revisions to the : F i pre access and random testing requirements ({ 26.24 (a) (1) and (2)) are intended to provide i licensees the explicit flexibility to adjust their testing programs to eliminate unnecessarily
- heroic efforts" to test. l The 60 day period was chosen in order to be consistent with the current preaccess precessing standards in NUMARC 9103, " Nuclear Power Plant Personnel Access Authorization Data Exchange Guidelines," dated October 1992. The industry guidelines provide that to be issued a badge in a situation where an individual has an existing access authorization, the individual must either be currently covered by an FFD program including l random testing, or have satisfactorily completed preaccess drug and alcohol testing within 60
' i 38 E- =.,+.-w-- -, - vn ., e[ v ,e.,r - = * ->--+,-e,v r~- - + w-- r- e-wy- w--r
days before badging, and be subject to a behavioral observation program and an FFD program. The industry guidelines also provide that the individual's activities should be checked if a licensee or contractor / vendor employee had bee's away from a licensee, or
~
approved contractor / vendor, behavioral observation program for more than 30 consecutive > days. The industry guidelines also provide that suitable inquiry should be updated if reinstatement of access is requested for an individual who has been away from an FFD prograra for a period of 30 days or mere. For workers who have been absent from the possibility of being tested under the , licensee's program for more than 60 days, any drug or alcohol test meeting Part 26 standards and performed within 60 days before the granting of unescorted access could serve as the
-c return to duty test. The returning worker would have to obtain a negative test result before returning to work unicss he or she has no history indicating the use ofillegal drugs or the misuse or abuse of legal drugs and has either had a negative result on a test meeting Part 26 standards performed within six months before the reinstatement of unescorted access or been covered by a program meeting Part 26 standards for two consecutive weeks during that six-month period. As was adopted for preaccess testing, tests performed by another licensee or t under a testing program required by the U.S. Department of Transportation are examples of tests that would qualify as return to duty tests under this proposed revision. In such circumstances, the NRC would expect that licensees would use a dependable means of ,
confirming that the person seeking access had actually been tested or been covered by another ,
- program. This could be accomplished, for example, by the electronic exchange of pertinent 39
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s . l information among licensees using a computerized data base that the industry is currently i Considerittg. Various proposed editorial changes to i 26.24 (d) would leave its requirements -! essentially unchanged from the amendment to this paragraph published by the NRC on - l i August 26,1991 (56 FR 41922). l The NRC is proposing a new paragraph ($ 25.24 [e]) that would require that licensees I keep to a minimum the time between notifying individua!s to be tested and the actual i collection of specimens. This requirement is intended to eliminate a significant vulnerability . e N (time) in the testing proctu. Time is very important to persons attempting to avoid detection. Yime enables them to flush themselves, obtain surrogate specimens, or obtain materials to f l dilute or adulterate their specimens. For example, an investigation was conducted to i I determine why t vo adjacent sites, drawing their workforce from the same geographic area, had significantly different positive rates for random tests. It was determined that different time intervals between notification and collection was the cause of the discrepancy. The licensee with the low rate had a 2 hour notification policy not vigorously enforced; the licensee with the higher rate had a 15 minute notification policy which it aggressively , t enforced. A DOT study showed an increase in the po.itive rate when there was little or no prior waming of specimen collection. Whereas " normal" random testing of motor carrier .
*' personnel were positive at a 2.5% rate, roadside stops produced at a 4.8% positive rate, in t' response to that experience, DOT revised its rule to require the person, upon notification, to j immediately proceed to be tested. NRC inspections and surveys indicate that some licensees I
keep workers on the job and test them only at the end of a shift even though they have been g 40
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notified that they are to be tested hours before, in other cases, licensees permit delaying tactics that result in lengthy periods between notification and testing. In both of these cases, alcohol can be metabolized below detectable levels and the person can Dush himself or herself, to some degree, of drugs. Some licensees release workers for tests in a manner that allows them ample opportunity to obtain materials that might subvert the test results (e.g., adulterants or surrogate samples kept in a locker or vehicle). The NRC understands that operational necessity may prevent the tested person from reporting immediately and that being escorted between notification and test may be an unreasonable burden. However, several licensees have reduced the notification time by using the supervisor to coordinate the worker's availability for testing and withhold notification until the individual must proceed to the collection site. Licensees report that this approach does not cause any burden or inconvenience; it is merely a different way of doing things. One licensee reported that it escorted persons selected for random testing without giving them prior notice, which produced a low number of questionable specimens (NUREG/CR 5758, " Fitness for Duty in the Nuclear power Industry: Annual Summary of program perfermance Reports," CY 1994, Volume 5, page C 5). Therefore, the Commission expects that licensees will assure that opportunities for subverting the test are eliminated as much as is practicable. Section 26.24 (c) (paragraph (f) in the proposed rule) currently requires that MROs' review of test results be completed and licensee management notified of those results within 10 days of the initial positive screening test. The intent of this requirenant is to ensure that results are obtained within a reasonable time after specimen collection. Industry experience has indicated in some cases that the current requirement is impractical. In order to make this 41
o l requirement more effective across the industry, the NRC is proposing to require that MROs' review of laboratory test results be completed and licensee management notined "as soon as I i practicable" after specimen collection and no more than 14 days after the collection of a l specimen. - Because many licensees condun on site screening tests, the
- collection of a j i
specimen" standard would establish a more consistent and controllable time line than " initial j screening test." The licensees conducting initial screening tests on site would have the same I amount of time to review the HHS certined laboratories' reports as do those licensees not conducting onsite testing. Experience has shown that the majority of certi6ed laboratories i take only 1 to 3 days from receipt of a specimen to screen and confirm tests; isolated i exceptions are usually caused by testing for 6 acetylmorphine (6 AM), formerly referred to as j 6 monoscetylmorphine (6 MAM), and occasionally by unusal technical problems. The Commission believes that most test results should be known to an MRO within 5 to 7 days . from specimen shipment to the laboratory. The Commission has no great concem where there ; is a legitimate technical basis for a short, reasona9 delay by the laboratory, for example, j where a specialized low volume test, such as 6 AM, is done twice a week rather than every i day. This revision would require, therefore, that MROs must advise licensee management of , available test results and of the progress of the review if the review has not been completed within 14 days of the specimen collection. While slightly relaxing the test result reporting requirements, the NRC would still expect MRO reviews to be completed as soon as - l , practicable, and, in accordance with a proposed clarincation of Section 2.9 (c) of Appendix A, I that the MRO notify management immediately after the determination of a positive test result: or other violation of FFD policy, l 42
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o . . The h.% also proposes to clarify i 26.24 (f) to require that the MRO inust report all violations of the licensee's FFD program to management in writing and in such a manner that confidentiality is ensured. This requirement is also proposed as new paragraph (i) in Section 2.9 of Appendix A, which addresses reporting requirements and the review of test results. This provision is simply a clarification of existing practice and an adoption of a change made to the fil{S guidelines in June 1994, and would not place a significant burden on licenas since it would require that only FFD program violations, rather than all test results, be reported in writing to management. Requiring that all determinations of FFD program violations be submitted in writing will assist in preventing reporting errors. Furthern. ore, although it is currently common practice to submit such information in a manner that ensures confidentiality, the NRC believes that due to the sensitive nature of the information this provision should be explicitly required, as llHS does in its guidelines. The NRC proposes to taodify 6 26.24 (g) with several editorial changes to clarity requirements for performing screening, confirmatory, and blind perfonnance tests at HHS-certified laboratories. These changes serve to clarify and explicitly state the currently existing practice by licensees. In addition, this paragraph and i 26.24 (d) would require licensees to ensure that all collected specimens are tested and that laboratories report results for all specimen tests performed. This provision serves to clarify existing requirements would be a cornpanion to the change to f 26.24 (f), and would be an adaptation of a change made to the HHS guidelines in June 1994, in which HHS required written reports on all specimens, both positive and negative, to ensure that all specimens had been tested and all results reviewed by the MRO. 43
. o ,
,i , The NRC is proposing to require that a confirmatory test for alcohol be performed if l
- the screening test indicates a blood alcohol concentration of 0.02 percent or greater instead of; i
0.04 percent as currently required ($ 26.24 (h)). In cases where the confirmatory test ; indicates a blood alcohol concentration between 0.02 percent and 0.04 percent, the resuh would have to be forwarded to the MRO for review and, if appropriate, back calculation (see new Section 2.9 (h) of Appendix A). The purpose of this procedure would be to detennine whether the tested person had a BAC of 0.04 percent or greater, indicating a Siolation of the l l FFD rule, at any time during the work shift Section 26.24 (h) currently provides for a blood test to be administered if the tested ' ! person demands further confirmation" of a positive confirmatory test for alcohol. The NRC is proposing to revise the regulatory language to better reflect the purpose of blood tests in j that they would be used for providing additional information that could be considered during l l an appeal pursuant to i 26.28. Furthermore, licensees would be required to ensure that the -[ blood specimen is drawn promptly after the confirmatory breath analysis. The result of the ; gas chromatography analysis of the blood specimen need not necessarily be measured against f the alcohol cut off level. Instead, the MRO should determine in these cases whether it is [ appropriate to extrapolate back in time to estimate the highest BAC that the worker had while on duty, in a related matter, the NRC desires data on the number of times blood specimens have been drawn and any instance where the BAC results were overtumed. Approaches licensees have taken to maintain this capability ar.d the associated costs would be useful for ! evaluation of possible future changes _in this requirement. t t
. ~ _ , ~ - , , - . _ ~ . _ - . . _ -
i i in another revision to this section, the NRC is proposing a new paragraph (f 26.24 (i)) [ i i to address cases where an individual has a medical condition that makes collection of breeth, i blood, or urine specimens dimcult or hazardous. The MRO, in consultation with the worker's -i treating or private physician, would be authorized to determine a method of specimen i collection provided the methods chosen can achieve comparable results. The Commission , f anticipates that these occasions, which would include, for example, post accident testing of an inkred individual, would be extremely rare._ ) in connection with the blood tests which may be performed under i 26.24 (h) and (I), th8 NF% wies the the Occupational Safety and Health Administration (OSHA) has determined thet some employees face a significant hedW risk as the resuh of occupational J exposure to blood and other potentially infectious materials because the materials may contain , i certairi bloodborne pathogens. OSHA published a final rule in the Federal Register on December 6,1991 (56 FR 64004), that establishes requiremen" applicable to all occupational ; l exposure to blood or other potentia!!y infectious materials. This coverage appears to include , 7 personnel involved in the collection and handling of blood specimens collected pursuant to the NRC FFD rule. The OSHA rule lequires employers that have one or more employees with this occupations) exposure to tak several measures to minimim the exposure. These ; measures include determining employees' potential exposure, establishing a written Exposure Control Plan designed to eliminate or mirimize c:nployee exposure, and taking various . r precautions to ptevent contact with blood in the course of work. The NRC anticipates that
, licensees will evaluete their responsibilities under this OSHA rule.
E 45 ;
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< j i f Section 26.2$ Fmniovee Aamimance Pronrams (EAP). i I j The NRC proposes to revise this section by replacing the permissive "should" with the i mandatory "must" to clarify its original intent that licensees design their employee assistance f programs to achieve early intervention and must provide for confidential assistance. W actually achieving early intervention in all situations whe's employees' problems could adversely affect on-the job performance may not b: possible, it is reasonable to expect that [a licensees' EAPs be designed to achieve this goal and not include obvious impediments to i early intervention. This would assure that self referrals are kept confidential and do not resul! in punitive action. The NRC wishes to emphasize that Employee Assistance Program staff shall inform licensee management when a person constitutes a hazard to himself or herself or others and that self referral does not influence in any way the determination of an FFD violation. , Section 26.27 Manmoement Actions and Sanctions To Be Imoosed. The NRC proposes changes throughout this section to require the same sanctions for
- alcohol violations as currently exist for use ofillegal drugs. Explicit sanctions were not contained in the original rule because the NRC wished to study the matter further. As a result - t of further study, the NRC concludes that impairment caused by alcohol abuse cisates a safety risk' that is fundamentally similar to the risk posed by the use of illegal drugs. Both types of abat involve violation of explicit licensee policies, are unacceptable in the nuclear power -
46 r
.-a- - . - ., - , - - . - . . - - -
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O , O , i l i a j industry, and should strongly be discouraged.- Currently, licensees vary widely in the;r i responses to alcohol abuse with sanctions ranging from a three-day suspension to termination. The FFD rule's lack of explicit minimum sanctions concern'.ng alcohol has created problems l 1 I for many licensees in negotiating and defending sanction decisions. Creating minimum i sanctions for alcohol violations that are equal to those of illegal drugs will assist licensees in iI dealing with these situations while sending a strong message to workers about the risks involved in abusing alcohol. As discussed under the proposed changes to { 26.20, it is
- important for licensees to ensure that their employees understand the several factors related to i alcohol consumption that could result in a violation of the licensee's FFD policy. ,
Section 26.27 (a) would be revised to clarify certain aspects of the requirements for ; the written statement obtained from persont seeking unescorted access and for the conduct of suitable inquiries, in both cases, the revisions would require licensees to determine whether the person has a history of substance abuse or has previously violated a licensee FFD policy. i These changes are being proposed with the' intention of requiring the gathering of more , complete information on the backgrounds of applicants for unescorted access, particularly as to potential problems with the abuse of alcohol, in addition, the history, except for removal from activiiles within the scope of this part due to rctions taken as the result of an FFD policy, would be limited to the last 5 years. It should also be noted that the proposed revisions are intended to ensure consistency between the suitable inquiry aspects of both the 1 access authorization rule and the FFD rule and that one suitable inquiry for each worker l should be sufficient to fulfill the requirements of the two rules. As in the Access 1 Authorization program, Nst efforts" requirements of { 26.27 (a) (3) are accomplished { 47
i l through contacts with previous employers, in addition, fitness history need r.ot be obtained j for those covered by other programs or absent for 30 days or less. The NRC has received recommendations that a standard form be available for all ! licensees' une in performing suitable inquiries into individuals' backgrounds as required by i this section. The NRC will defer to licensees should they wish to develop and use this type _ ; e of form. There have been a few rsports of instances where a contractor or vendor employee j with concurrent unescorted access to several power reactor sites had tested positive and that j information was not shared with the other licensees. Although the individual was denied ; accen by the testing licensee, the unescorted access status was continued by the other licensees. The NRC considered requiring. licensees to assure that such notifications are made or to make periodic checks with other licensers and contractor employers but believes that the j licensees' procedures to implement the access authorization ru% (10 CFR 73.56) should facilitate the sharing of the information. . Section 26.27 (b) (1) would be revised to clarify several points. Applicants would be , added to the types of people to be denied unescorted acceu if their fitness is questionable. Violations of FFD policy, such as refusals to test u subversion of the testing pmcess, is added as a basis for denial. The successful resolution of the impairing or questionable i condition has been added as a condition to assign'nent of duties, and a more systematic ] review of the fitness of all personnel beirg returned to duty whose ntness had been deemed
; questionable would be required.- This action is being taken because there have been several instances in which licensees did not temove or delayed removal of workers whose fitness was 1
48 i
questionable and " automatically" returned workers to duty without a test or adequate determination of fitness. Companion changes are proposed for { 26.3, conceming medical determination of fitness, and i 26.24 (a), regarding for cause and return to-duty testing. The NRC proposes various amendments to j 26.27 (b) (2) and (3) [formerly one paragraph (2)] The first amendment would more clearly specify that confirmed positive drug ar.d alcohol testing determentions are to be considered violations of FFD policy. Another amendment would clerify that people who are suspended because of policy violation are still to be covered by the licensee's FFD program with respect to behavioral observation, chemical testing, and sanctions for violations and that a positive test result during the assessment or treatment period would constitute a second positive test. In a related matter, the NRC expects that, in those rare cases when an individual is randomly tested before the results of a previous ! test are known to the individual and bo'h results are positive, the licensee will consider whether the second test result is likely to be the result of the use indicated by the first test and, if not, declare the second test to be a second positive and take appropriate acticn. As amended, this paragraph would also require that a person who is reinstated following a policy violation must successfully complete a retum to-duty test and be subject to subsequent follow-up testing. Section 26.27 (b) (4) and (5) (formerly paragraphs (3) and (4)) would be revised to fully recognize the abuse of alcohol es an FFD violation. The NRC also proposes to revise paragraph (b) (5) to more directly express its intention that a person must be determined to be l fit to safely and competently perform activities under Part 26 by an appropriate licensee l l manager and the MRO or other qualified physician before being returned to those actisities. l l 49
o I . 4 Like other proposed amendments to this section, these amendments would be intended to - elevate the importance given to licensee decisions regarding unescorted access reinstatement following FFD policy violations. Section 26.27 (c) would be clarified so that the exact act that violated the FFD policy is recorded and provided in response to an inquiry. Subversion of the testing process would be added to the examples of violations that must be recorded and provided in response to a suitable inquiry. Each of these examples of employee activity would be a violation of the licensee's FFD policy. A new provision would require that any attempt to subvert the testing process must result in denial of uriescorted access for a minimum of three years which would l be consistent with the sanction required by ( 26.27 (b) (3) for a second violation of a licensee's FFD policy. This sanction was chosen because the NRC wishes to convey the seriousness of such acts. Lastly, paragraph (c) would be revised to allow licensees to dispose of records five years following denial of any access authorization resulting from the activity. i These revisions would establish a basis for consistent mmimum treatment of these violations across all licensee programs for employee activities that have resulted in varying licensee response during the first five years of FFD program operation. The NRC also proposes to revise paragraph (d) of f 26.27 to direct licensees to treat NRC contractors similarly to NRC employees if a licensee believes an NRC contractor to be under the influence of any substance or otherwise unfit for duty. The NRC is aware that the requirements of the American with Disabilities Act of 1990 , (ADA) may have implications for licensees' compliance with the requirements of 6 26.27. The employment provisions of the ADA, which became effective on July 26,1992, require 50 ,
employers with 25 or more employees to pmtect disabled persons from discrimination in the
**wkplace. People who have previously been addicted to drugs or alcohol but who have been successfully rehabilitated, or can demonstrate a successful period of abstention or negative test results, are among those the the ADA protects. It is the NRC's understanding that a person who has casually used drugs in the past but was not addicted to those drugs cannot claim the ADA's protection. The Act specifically excludes from its protection employees or applicants who are cunent users ofillegal drugs. The Act also specifies that covered entities may require employees to comply with the FFD regulations of the NRC to the extent such employees are covered by these regulations (Sec.104(c)(5)(B), Pub. L.101336,42 U.S.C.
12114; see also 29 CFR 1630.16(b)). The Equal Employment Opportunity Commission has published the Americans li'ith Disabilitics Act Technical Assista sce Alanual which somewhat clarities the meaning of
" current use" of illegal drugs. According to the Afanual, "cunent use" is drug use that has occurred recently enough to justify an employer's reasonable belief that involvement with drugs is an on going problem. For purposes o rtaking an employment action, current drug use is to be determined on a case by-case basis and is not limited to the day of use or recent days or weeks. Clearly, when determining whether a particular person is a current user of drugs, and therefore not eligible for ADA coverage, the required amount of time that mest have elapsed since a person's last use of drugs must depend to a large extent on the nature of the particular employment context in which an employraent action is being considered. This is confirmed by the Afanual when it states that an employer may take an employment action against an employee with a history ofillegal drug use if it can demonstrate that the individual 51
i I poses a direct threat to health or safety because of the high probability that he or she would return so illegal drug use. . P The NRC's policy, as reflected in 10 CFR Part 26, is that until a person can show that , l he or she has abstained from substance abuse for at least three years, there is a continuing probability of resumption of substance abuse that is too hig' given the exceptional safety , concerns of the nuclear power industry. This has been supported by medical evidence and , clinical experience. Given the heightened safety concerns of the nuclear power industry, it is the N.'C's view that a person is a current user and not a disabled person under the ADA because of drug or alcohol abuse until that person has demonstrated abstinence from substance abuse for a minimum of three years after a positive test. Even when con:ldered disabled because of drug or alcohol abuse, a person covered by a program pursuant to 10 CFR Part 26 i is by terms of the Americans With Disabilities Act still subject to the NRC's fitness for duty regulations. Section 26.28 Anneals. The NRC is proposing amendments to the -ight to appeal granted by ( 26.28.- This section currently requires that people subject to the rule have an opportunity to appeal positive drug and alcohol test results, in keeping with revisions to several other sections that would be
- intended to counter testing subversion, an amendment would extend this right to appeal to all determinations of FFD violations.
52 wv-,i-m,- , . , , , av -- , , ,w, . - * , -w=, .w,, e,- -,w,., .m,- ,,, .--,....w.. m.,.,w,,- =,=,.--ww
_- ..-.- - - -.- ~.- -. - - - -. - - - -. - . - _ . t i l l The NRC proposes to clarify that the right to appeal includes applicants for unescorted l access. The NRC understands that some licensees did not provide an appeals process to persoi.s who tested positive on pre access tests. The factors that could produce false positives among licensee er.;ployees and contractors (e.g., administrative errors, medical prescriptions) { are equally likely to occur during pre access testing of applicants for unescorted access. (Note ; that a change so i 26.24 will permit licensees to consider any test meeting the Part 26 standards as a pre access test. Those standards include the appeals process under i 25.28, and , apply to any test that the licensee plans to subsequently use as a pre access test.) If applicants , for unescorted access are not provided an appeals process, it is possible that some of them will be efTecti ely barred from the industry based on test results erroneously determined as i positive. Providing applicants an opportunity to appeal the validity of the test result would also enhance program credibility. . 4 The NRC also proposes to clarify the contents and purpose of the notice to the individual determined to have violated an FFD policy, clarify that the review process must bc objective and impartial, clarify that the individual may submit additional relevant information, exterd arpi rights to applicants for access, and assure that relevant records are corrected if an appeal is successful. The NRC understands that, in some cases, the individual did not mderstand the purpose of ti.e appeal process. The NRC also understands that, in many instances, persons responsible for the initial determination were conducting the review. The l ~ NRC believes that the effectivenen of the FFD program depends, to a large extent, on the , perception by the workforce that the program is fair and worthy of their support, and that all reasonable efforts are being made to ensure that any decisions that could affect their careers 53 ; F 1
' , . - - 4. -
..m.,. ,m. ,,.,+m,_. .,.#m-. -mm-,,._m.._-,- .-.~.,mnw..-,,- , w rm --w.e , _wy_,.,,ny,.- .. .,.r.-., . , , , , , , . v y .r 7 r re .
t . l are fair and based upon information that is complete and accurate and forms a sound basis for ) the decision. The use of even-handed, fact-finding procedures should ensure that incorrect determinations that could undermine the quality of a licensee's workforce and, thereby, be counter to the interests of safety, will not stand uncorrected. As a related concem, the NRC has been informed that some licensees have required individuals to py for the reanalysis of their specimen and the analysis of their split sample when pursuing appeals. Having to pay for the reanalysis can be expected to obstruct the individual's exercise of the right to appeal the licensee determination of policy violation as granted by this section. The NRC, therefore, considers requiring persons covered by the rule to pay for reanalysis of their specimen or analysis of the split sample to be inappropriate, llowever, requiring the person to pay after the fact should these subsequent tests also be positive would be an acceptable measure to control unwarranted appeals. Section 26.29 Protection ofInformation. The NRC proposes to amend this section to clarify that contractors and vendors who legitimately seek information for unescorted a: cess decisions by licensees are authorized to obtain this information. Cortractors and vendors were unintentionally omitted from this provision in the original rule. A second proposed amendment would allow disclosure of personal information collected in compliance with the rule to presiding officers of judicial or administrative proceedings that are initiated by the person who is the subject of the information. The 54
1 purpose of this amendment.wduld be to allow disclosure to, for example, state agencies. mvestigating whether the firing of an employee was justified in order to determine unemployment compensation e'ntitlements. This disclostre would be permissible as long as the subject errployee ' initiated the proceeding. Section 26.29 (c) would be moved from current j 3.2 of Appendix A and amended to e clarify that licensees must provide to the subject individual, upon written request, copies'of all records pertaining to violations of FFD policy, including test results, MRO reviews, and management determinations pertaining to the individual. Some licensees have interpreted this section in ways that make it difficult for workers to obtain their records. For example, some , licensees have allowed the tested persons to see the documents but have not provided thein , copies of the documents. This is particularly difficult in the case of contractor employees who may no longer reside in the plant area. These actions are contrary to the NRC's intent - that persons covered by the rule have full and convenient access to documents pertaining to employment actions taken in response to the results of tests conducted under this rule. Section'26.70 Insnections.
- The NRC is proposing to revise this section to clarify its intent that FFD service contractors must make available for inspection by duly authorized representatives of the Commission documents, records, and reports related to the FFD services they provide to licensee, contractor, or vendor FFD programs. In some instances,' contracted service providers -
and testing laboratory personnel have been reluctant to provide documents to NRC inspectors. 55
1
.E Section 26.71 Racordkeeninn Reauirements. .
l The proposed amendments to this section would clarify the NRC's intent that licensees: retain relevan't records pertaining to determinations of FFD plicy violations, not ),st records
- of confirmed positive test results. These records are to include those related to personnel .
actions following policy violation determinations (such as refusals to test and subversion of the testing process) as well as those pertaining to the testing process that detects the violations. This revised wording would clarify licensees' recordkeeping responsibilities as well as ensure that people covered by the rule would have sufficient access to documentation
-of personnel actions that can su b stant i ll a yffa ecthi k status.
t e r wor I_ l The proposed amendments to this section would also reduce the reporting frequency for program performance data from semiannually to annually and add the number of subversion attempts by type to reporting requirements to support the greater emphasis on subversion elsewhere in the proposed rule. The NRC has considered, but decided not to adopt, a recommendation that utilities with more than one site submit only a single semiannual program performance report for all sites. Such consolidation of data would prevent analysis of site specific performance and NRC inquiry into obvious inconsistencies such as large numbers *of pome results at one site and no positives at the second or neighboring site. Despite obtaining the FFD programmatic performance information that has been submitted pursuant to this section for the five years of program operation, the NRC believes that add:.bnal types _of information could be useful in fulfilling its responsibilities of 56 w 4--- , , w
.+ ; . .,
. ,s -
q 4 overseeing licensees' FFD programs and formulating public policy. As noted in th"e . introduction to this notice, several parties have recommended that the NRC consider ob'taining - certain types of information in addition to those currently required by this section or now > being proposed for inclusion under i 26.73. Such information coula include the number and : nature of grievances, arbitration proceedings, and lawsuits stemming from FFD-related issues; information related to licensees' EAP programs including types of senices provided, whether ; such services are provided by licensee or contractor personne;, employee-to-counselor ratios,- the number of personnel who are admitted to EAP programs by self referral and by
. supervisory refmal, the reported and diagnosed problems,'and overall results of EAP ,
programs; and laboratory testing results that are being provided to MROs and what problems MROs are having in interpreting test results and making judgments as to whether FFD policy violations have occurred. [ Having access to this information would enable the NRC to gain a clearer and more detailed understanding of the actual operation of the programs. This information would also be useful for purposes of revising the regulation or providing guidance so that the general 1 performance objectives stated in 6 26.10 can be better achieved. The NRC, therefore, seeks public comment as to whether f 26.71 (d) should be revised further to require that these types of information be collected and analyzed by _ licensees and submitted to the NRC. The NRC -
.4 seeks public comment as to whether the NRC should develop a management information system similar to that promulgated by DOT and its operating administrations (58 FR 68194
- through 68285; December 23,1993).
i. l , .57 s rw r,-1,,=,,n, ,- -- *,t e em . c ,, ua'-.,e - o c--., .e-w . . . . - r +,-4 v-r-m,-w- . s . . - . - - , - - - - , - - - - - , - - - ,,- r
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- i
- i The NRC ' wishes to acknowledge the usefulness of lessons learred and program initiatives reported by many licensees that are summarized in NUREG/CR 5758 each year for ,
licensees to consider and use to improve their programs and avoid common problems. , Section 26.73 Reoortino Reauirements. 1 The current rule requires that licensees inform the Commission of significant FFD events and describes examples of significant events involving acts by licensed operators and supervisors that must be reported to the NRC. Item 10.1 of NUREG-1385 emphasized that the NRC expects licensees to exercise prudent judgment on whether or not unusual situations
' should be reported and that the significant events were not limited to the examples contained in the rule. However, the NRC understands that many significant events that would be useful for formulating public policy or that the NRC should responc to in a timely t shion have not been reported because licensee management decided not to report the event unless it was specifically required by the rule. Therefore, the NRC is clarifying that significant events are not limited to those listed and provides additional examples. One of the proposed
- amendments would add FFD program personr.el, in keeping with clarifications to the scope of the regulation under { 26.2 (a), as a class of individuals whose improper acts would be ,
- reportable. Another proposed amendment would expand an example to include that my violation of FFD policy (e.g., possession'of illegal drugs, refusal to take a test, attempt to t
subvert the testing process) by a supervisor, licensed operator,- or FFD program personnel 58
..-.g - , - - - ,,,-,-a , + - - a
9 must be reported in contrast to the current examl il e which describes reporting only confirmed positive test results. Section 26.80 Audits. This section would be revised to permit licensees some discretion in conducting audits and to address a petition for rulemaking (PRM 2o-1) filed on January 19,1994. Rather than emphasizing compliance with a requirement to conduct an audit at a fixed armual frequency, licer.ees would be responsible for determining the appropriate frequency, scope, and depth of auditing activities within a 3 year period based upon a review of program performance indicators. These performance based aud.s would be conducted so that all program elements are adequately covered at least once during the 3-year period. In addition, the interval between audits of a program element would be relaxed to 36 months. The NRC is specifically interested in public comments on program performance indicators in addition to those contained in the text of the proposed amendment to the rule and whether they should be added to the rule or included in a guidance document. This relaxation of audit requirements would not be extended to contractors and vendors, whether they are implementing any portion of a licensee's program for their employees under the provisions of Q 26.23, or providing contracted FFD services, such as specimen collection, testing, and MRO reviews. The amendments to this section would also clarify that licensees must continue to audit their HHS-certified laboratc, ries on an annual basis. 59
I The NRC recognizes that FFD is an evolving discipline and that new issues and-problems will continue te 3 Le. In some cases, turnover of FFD program personnel further -
- exacerbates the problems. There is a frequent turnover in the contracted services, such as specimen collections, MRO reviews, and EAP services. Licensee audits have found many problems that were associated in some way with personnel changes. A proposed amendment -
to this section would require licensees to audit program elements that may potentially be
- affected by significant changes in personnel, procedures (e.g., specimen collection, testing, and MRO reviews and reports), or equipment as soon as reasonably practicable but no later than 12 months after the changes. The purpose of these focused audits would be to assure that the change has not adversely affected the operation of the particular program element or l function in question. One of the clear lessons of the early period of this rule's
-implementation during 1989 to 1991 was that licensees that performed early pro-active audits L
l
.of their FFD programs were able to more easily and effectively. correct programmatic l
I problems and achieve effective program operations than those that waited the full nominal 12-l month period before auditing their programs. Accordingly, this aspect of the performance based audit program would help ensure that whatever programmatic problems that may result from significant changes in personnel, procedures, or equipment will be detected and corrected L L on a timely basis, Licensee audits of HHS-certified laboratories continue to find problems. In one case,< the licensee's auditors had found sufficient problems in the first part of an audit to issue a I l stop-work order. - The laboratory subsequently lost its HHS certification. Therefore; based on experiences gained to date, the NRC continues to believe that licensees must continue to audit 60 f~ .
l . l , at least annually the quality of contractor or vendor-performed program elements, particularly when such activities are provided off site or are not under the direct, daily supervision of the licensee. With respect to the petition fo .ulemaking, which was filed with the Commission by Virginia Power and assigned Docket No. PRM 26-1 on January 19,1994, the petitioner requested that the Commhsion's regulations be amended to relax the existing mandatory audit frequency and require each licensee to audit its FFD program nominally every 24 months instead of nominally every 12 months with additional audits if performance warrants. The petitioner requested tl.e change based on its contention that the present requirement ir resource intensive but of marginct importance to safety. The petitioner's further basis was that the 8.idustry's performance in ensuring a drug-free workplace has been very effective, the frequency and extent of auditing should be based on the need to assess performance, and that the licensees need increased flexibility to concentrate available audit resources in areas of observed weakness rather than mandatory audits of marginal safety significance. The petitioner stated that such a change would be consistent with audit requirements concerning operational safety, and that the blind performance test procedures and the quality cont ols required by Section 2.8 of Appendix A to 10 CFR Part 26 provide sufficient controls to ensure continued reliability and accuracy of the chemical testing. The petitioner indicated that its proposed change is n'.t intended to preclude additional or more frequent audits if perfonnance trends indicate additional overview is necessary. The NRC believes that its proposed changes would go beyond that requested by the petitioner in that the interval for auditing the FFD program would be 3 years instead of 2, and 61 h - . .. . . .
6' e
- the actual interval of the audits would be based more on need, as demonstrated by performance, than at a fixed interval. Therefore, adoption of the proposed change by the NRC would grant the petitioner's request with respect to audits of licensee programs.
However, the NRC believes that licensees must continue to vigorously audit contractor / vendor performed program elements, and has maintained the existing frequency of these audits. The .dRC understands that licensees have assumed that the term " audit" in Part 26 means a quality assurance (QA) audit that conforms to their normal audit program requirements and American National Standards institute (ANSI) standards, such as ANSI N45.2, " Quality Assurance Program Requirements for Nuclear Facilities," ANSI N45.2.12,
" Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants," ANSI N45.2.23, " Qualifications of Quality Assurance Program Audit Personnel for Nuclear Power Plants," and ANSI N.18.7, " Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants." The NRC does not require that these audits be performed by the QA organization la accordance with the QA program commitments for the conduct of nudits. As stated in the current rule, the NRC expects that these audits must be conducted by individuals who are qualified (technically competent) in the subject (s) being
- audited and are independent of the program (to assure objectivity and no conflict of interest).
'At the licensee's option, the QA organization may perform, lead, or assist in these audits.
The following discussion describes the changes to Appendix A to Part 26 that are being proposed and the reasons for the changes. 62 a 1,-*s' w- - we-q --- a rw w 7
.u Section 1.1 Anolicability.
Numbering changes to this section are being proposed to ensure uniform style and format throughout the rule. Section 1.2 Definitions. Proposed changes to this section include deletions of defined terms that are either redundant with definitions in i 26.3, were moved to f 26.3, or are clear in the context of this Appendix. A proposed revision would define " limit of detection" (LOD) which is now used in the rule. Another proposed amendment would delete the term " permanent record book." This change would make the Appendix consistent with recent amendments to the HHS guidelines and the Department of Transportation FFD regulations that eliminated the requirement for a permanent record book. Because HMS no longer requires a permanent record book, the NRC proposes to remove requirements for a permanent record book throughout the rule. The permanent record book was originally required based on the belief that such a book was necessary to ensure that critical information regarding collection and testing of each individual specimen was recorded. However, the FFD drug testing program specified in Part 26 requires that all information on individual tests be recorded on the chain-of custody form and other forms and requires that all information related to determining violations be retained for fivc years. Therefore, there is no compelling need to maintain a separate longstanding record book. Eliminating this requirement reduces the regulatory 63 l
t . l burden on licensees and increases the efficiency of licensee drug testing programs (because the time taken to enter information into the record book while the testee waits is eliminated). The elimination of this requirement does not preclude licensees from making their own determination of the advantages of the use of a permanent record book and deciding to continue to maintain one. A definition of " limit of detection" has been added to support some of the several proposed changes intended to cope with subversion of the testing process and to protect individuals from incorrect allegations of weh attempts. Section 2.1 The Substances. The NRC proposes to amend this section to include return-to-duty testing and to clarify that when a licensee tests foi any illegal drug during a for-cause test or analysis of a suspect specimen (currently permitted by the rule), the licensee may consider any detected drugs or metabolites (as currently authorized in section 2.7 (d) of this Appendix for samples suspected of adulteration or dilution). The NRC deems it appropriate, in these particular instances, where reasonable suspicion of an FFD problem exists, to allow close scrutiny at the dis *etion of the licensee. The licensee continues to be responsible for assuring that the results establish a valid basis for any action taken. The NRC has given consideration to adding additional substances to the panel of drugs to be tested (e.g., benzodiazepines, barbiturates, and/or LSD) but has chosen not to add substances at this time. In the interests of developing and maintaining a coherent and well-organized drug testing program, the NRC anticipates continuing to follow the lead set by HHS 64 l
~
in its guidelines. HHS reviews' the panel of drugs from time to time from a national perspective. At this time, the NRC prefers to have any new additions to 'he minimum required drug panel dependent on HHS first adding substances to its panel of drugs to be L tested. However, should the interest of public health and safety indicate a need to add: substances to the drug panel, the NRC will take appropriate, timely action.- .The NRC continues to expect a licensee to consider any localized patterns of substance abuse when
' designing its FFD program, as required by { 26.24 (c).
- Section 2.2 - General Administration of Testina.
Section 2.2 (a) would be amended to clarify that licensees may dispose of chain-of-custody forms associated with FFD policy violations after 5 years and need not retain chain-of-custody forms recording no FFD violations or other anomalies after appropriate summary information has been recorded for program administration purposes. Licensees recently
- pointed out that current rule does not permit destruction of these records and that they have started to accumulate an appreciable volume of files. The retention of records for 5 years following Imnination of unesconed access would provide appropriate records for responding to background investigation inquiries while reducing the storage burden on licensees.
Proposed modifications to section 2.2 (d) (4) would clarify that the optional blood test for - alcohol misuse is intended for use in a subsequent appeal of a confirmed positive alcohol test.
, By asking for a blood test,'the individual is asking for information that can be used to appeal s licensee's determination of an FFD policy violation.
65 4 y i',-,.'a'- r- t-'--+--4 9 4 - - - - --
'*-+ '----' * - -- -- " *- -- -" -
Section 2.3 Preventine Subversion of Testine, ' The proposed amendments to this section would clarify the individuals for whom appropriate background checks and psychological evaluations are required and would reduce the required frequency for those activities from every three years to every five years. These changes were made in response to licensee experience and for consistency with generally accepted security practices for reinvestigations into reliability and trustworthiness. This section also contains clarifications that would conform with proposed revisions to { 26.2 that would clarify the Commission's original intent that FFD program personnel responsible for the administration of testing would meet the highest standards for honesty and integrity and be under the drug and alcohol testing requirements of the rule. These additions specify that testing of FFD program personnel shall, to the extent practicable, be done by personnel independent of the FFD program. Rather than describe in the rule how this requirement should be implemented, the NRC recommends that the random selection process, specimen collection, and testing services could be considered for performance by licensee employees specifically qualified for these infrequent duties, persons under contract to meet this-requirement, or an exchange of services arranged among sites or utilities in the same geograohical area. Alternatively, if a licensee maintains FFD programs both on site and at corporate headquaners, the FFD personnel who administer the program at headquarters could administer the testing of on site FFD personnel and vice versa. This requirement is intended to reduce the possibility of FFD program personnel being responsible for testing themselves or their close colleagues. Unless otherwise specifically 66
-Q 0-covered by the rule, personnel selected to test FFD program personnel would be independent of the administration of the FFD program to the extent practicable.
Ssption 2.4 Soecimen Collection Procedures. ; Ti. NRC proposes a number of changes in this section to increase the clarity and consistency in the wording of the rule. In additi,n to minor editorial changes, the NRC proposes to clarify 6 at there is no requirement for the courier's signature to be included on the chain-of custody form () 2.4 (d)). Because specimens are scaled in packages that would indicate any tampering during transit to the laboratory, and couriers, express carriers, and postal service personnel do not have access to the custody and control forms, there is no need l for such personnel to document the chain of custody for the package during transit. This is in keeping with standard forensic laboratory procedures and would streamline the specimen transportation process. This is also consistent with a recent revision to the HHS guidelines. In regard to suggestions that the NRC specify actions to be taken if there is a break in i the chain of custody, the NRC is aware that the Department of Transportation end HHS have published guidance that addresses the proper handling of breaches in the chain of custody in the transportation industries. The NRC believes this type of guidance is not necessary in the i ruir 'out expects that licensees would take action to discover and correct problems with the custody and control of specimens. Licensees should be aware that, when actual breaks in a specimen's chain of custody are detected and confirmed, the te::t result associated with that t specimen must be invalidated. The NRC notes that judicial rulings indicate that minor
" administrative" problems should not be considered breaks in the chain of custody Examples i
E include failure to include a middle initial or one digit of a social security number being l 67
incorrect, which are among the many techniques used in attempts by individuals to invalidate tests. Another " administrative" example found by the courts not to be a break in the chain is the collector and donor leaving a scaled specimen bottle unattended for approximately I rninute with reasonable measures in place to conclude that no person had access during that period. This should not be interpreted to mean that the courts will accept sloppy collection procedures. The Commission expects that licensees will be suf6ciently diligent and attentive to detail in this matter. The NRC would also note that licensees that test urine specimens for the five drugs specified in Appendix A to Part 26 at the specified concentration levels can use the OMB approved Federal Drug Testing (chain-of-custody) Form (OMB Number 9999 0023) developed by the Department of Transportation and HHS and published in the Federal Register on August 19,1994 (59 FR 42996). Licensees that test for additional drugs or use cutoff levels different than established by HHS in its laboratory certification program may not use the OMB approved form, but should use a "look alike" form. That the collection site person shall note on the chain-of-custody form any unusual behavior or appearance of a person being tested remains a requirement of Section 2.4 (g) (9). The NRC has noted and considered the privacy considerations associated with this requirement and continues to believe that the need to take note of such behavior or appearance is an appropriate part of the testing process. Clarification to Section 2.4 (f) would assure that a specimen of questionable validity would constitute a reason to believe the individual may alter or substitute a specimen. In accordance with HHS Guidelines, the NRC proposes to eliminate the directive that tested individuals be provided an opportunity to set forth on the chain of-custody form information concerning medications taken or administered in the past 30 days (Section 2.4 (g) (4)). The availability of such information does not eliminate the need to do a confirmatory 68
.- , .
- l t
- z. ,
test on an unconfirmed positive screen test result.. This information becomes useful only at. j
- the point at which the MRO reviews a confirmed) positive test result. : It is at_this stage, when ;
i this information can be conveyed by the tested individual directly and confidentially to the MRO, that information about medications the person may be using or has used becomes'
. germane to determining whether a fitness-for-duty policy violation has occurred. Eliminating ,
- the opportunity for the tested individual to provide this information on the chain-of-custody form would enhance the individual's privacy interests by precluding the chance of any testing ,
program or licensee personnel other than the MR4. earning of the individual's use of medication. The NRC proposes to amend Section 2.4 (g) (10) to allow licensees to have an- 1 individual, other than a collection site person, accompany an individual into a rest room not in the . designated collection site if the designated collection site is inaccessible. The NRC also proposes to amend Sections 2.4 (g) (15) and 2.4 (g) (24) to allow licensees to have an individual, other than a collection site person, observe the collection of a specimen whenever there is reason to believe the individual may have altered or substituted the specimen. ; i However, the requirement that the individual be of the same gender as the employee still exists.- This proposed change is based on NRC's belief that it not always possible, under all circumstances, to have a collection site person of ti.e same gender available. These revisions- ? are consistent with the June 1994 changes to de HHS guidelines. The NRC proposes reducing the required urine specimen quantity from 60 milliliters l
]
-(ml) to 30 mi for the primary specimen and, when split specimens are collected, to require the collection of an additional 15 ml (Section 2.4 (g)(11)). This change conforms with recent revisions to the HHS guidelines Because some licensees conduct on-site testing and test for additional drugs, they may need to collect an additional volume to meet these needs. - The -
l 69
. . . .o, __. _ _ _ -_ . 2 _ __ _ __ _ __
. _ . . - - e _ __ _ - ._ . ._ _ .._. _ _ . _ . . _ _ _ __ _ _
e a NRC understands that laboratories require only.a few milliliters for testing and that a 30 ml . sample is sufficient in volume for both immediate testing and for the retention of a second J aliquot for further testing, if necessary. The NRC also understands that accurate measurement y of specimen temperature is difficult with a small volume but does not believe that " partial"- l specimens should be disposed of and not tested. Reported experience in other industries-indicates that the con umption of water by those unable to give a urine specimen should be limited to one 8-ounce glass of water every 30 minutes but not to exceed a maximum of 24 ounces. This rate would protect the health ofindividuals who are providing specimens and is consistent with the recent revision to the HHS guidelines. t The NRC proposes changes to the collecti >n procedures to ensure that a urine specimen is not adulterated or diluted and to' detect surrogate samples being submitted. Licensees have reported several examples of specimens being adulterated or diluted and surrogate samples being submitted. This experience is consistent with that of other workplace programs discussed at HHS's Drug Testing Advisory Board meetings. These recommended ' ~ changes reflect the NRC's desire to minimize the vulnerabilities in the collection and testing of urine sp cimens that substance abusers have exploited, in addition to limiting the time l between notnication and collection recommended in 6 26.24 (e), the first proposed change in the collection procedure in Section 2.4 (g) woald provide clearer guidance that an observation f of a y-ine specimen for color and clarity be used to identify only obvious signs of adulteration i b - (Section 2,4 (g)(14)).l Urine color and clarity are affected by a wide range of physiological changes including an individual's health, level of hydration, medications, and diet. Test L personnel should therefore use observation of color and clarity of the specimen only for gross signs of adulteration.- These may include crystals settled in the bottom of the container, off-colors such as blue or green, and an excess of bubbles when the container is shaken. The 4
. t r.
.. 70
, - - n we v,+ve e -.-w-,sww-o- - N-5y
w *.
, l second proposed change (Sections 2A(g) (13) and 2.4 (g) (15)) would establish a narrower '
temperature band for acceptable urine specimens, with a minimum temperature of not less , c than 34'C/9ef (now specified in whole nuinbers in accordance with HHS guidelines). This j should make attempts to submit surrogate samples more difficult and, together with other -- changes, would be consistent with practices by a few licensees that have produced good results.LThe third proposed change would allow licensees to set their own parameters, within 3-the range set by the rule, of the accepted urine temperature range. This increased flexibility recvgnizes that there are a number of acceptable options for recording temperature and that each allows different minimum and maximum acceptable readings. For example, some temperature recording devices are located in the specimen container and record a " peak" temperature immediately. The temperature that is expected to be recorded by this device is close to core body temperature- a temperature that could occasionally require a second specimen under direct observation under the current rule. The current temperature requirement is based on a method that records the temperature several minutes after the - specimen leaves the body. The range of temperatures (i.e., the spread between the minimum and maximum acceptable temperatures) must be limited as specified in the rule. The type of temperature reading device, and the acceptable range of temperature for that device, must be specified in the licensee's procedures. Two other proposed changes would reduce the likelihood of undetected tampering by requiring secure sealing of specimen bottles and, in accordance with HHS guidelines, shipment in tamper evident containers. 4 The NRC proposes two changes in this section with regard to testing for alcohol (Section 2.4.(g) (18)). First, the NRC proposes to remove the requirement that the worker-undergo a second breath test for alcohol when the first test is essentially zero (less than 0.01-BAC). The licensee may, at its discretion, collect and measure the breath a second time. 71
e , !
- This change reduces the impact on individuals being tested and on the licensee by redwing l
- the amount of time taken by the testing process. It has been determined that a second : q
- negative test result is not technically necessary. Second, the NRC recognizes that alcohol is
~
metabolized relatively quickly (nominally 0.015 percent BAC per hour) and proposes to make explicit that the length' of time between a confirmed positive breath ~ test for alcohol and the , drawing of a blood specimen to test for purposes of appeal must be minimized. This _ proposed amendment would require that the interpretation of the results of such a test must consider the time elapsed between the confirmed positive breath test and the drawing of blood for use in an appeal process. Section 2.4 (g) (24) [formerly'(25)] would be revised to provide flexibility in internal reporting and actions when an individual fails to cooperate. The NRC proposes making various revisions to the requirements for specimen
. preparation and transportation to the ufS-certified laboratory or to the licensee's testing facility to decrease the chance that specimens will be degraded between the time they are collected and the time they are screened and confirmation tested (Section 2.4 (i)). Reports from several licensees have suggested that specimen degradation during shipment has been the ,
cause of" false negative" test resuhs. The NRC has been advised that specimens not kept chilled during storage or transit may have become contaminated because of the buildup of bacteria and their wastes to an extent sufficient to ponibly alter laboratory test results. Information on this phenomenon is limited and there are conflicting opinions regarding the seriousness of the problem. For exampk, one MRO stated that 19 of 21 on-site screening test positives we e not confirmed because of degradation of the samples during shipment. _(See Appendix B to NUREG/CR-5784.) Also, the reasons for unsatisfactory results of blind performance tests reported by the HHS-cenified laboratories are that the blind specimens
~
L 72
'., - - ~ . . . - . _ . , . , . , _ . . - , - , , , -
-- degraded below the cutoff levels or that the specimen containers adsorbed some of the drugs or metabolites. Therefore, the NRC has conducted pilot tests to gain additional insight on whether specimen degradation was a problen;. These pilot tests detected a significant level of cocaine metabolite deterioration when urine specimens with a high resative acidity /alksdinity (pH) level were stored at relatively high temperaturers (i.e ,100* F) for 36 hours or more. A modest study by one licensee showed a definite decreue in the concentration levels of THC in specimen . bottles stored at room temperature for one wee'c (e.g., from 199 to 178 r.,/mL);
where the specimen was allowed to touch the inside of the cap sealer, the concentration was reduced more than one half (e.g., from lY9 to 77.8 ug/mL). The NRC specificelly invites comments regarding the proposed revisions concerning specimen degradation and whether rule changes should be made or the information published in report form for voluntary use. In particular, the NRC is interested in data that licensees conducting on site testing could provide. Of specific interest wou!d be examples of on site uncontirmed positives that had degraded during shipment. Licensees or other parties submitting such information should include any known factors, such as temperatures and duration of exposure to the su:.pect . condition, that may have contributed to the problem. , At this time, the NRC proposes two specific revisions intended to address this-specimen degradation problem. The first revision would continue to require that urine specimens be shipped to the HHS-certified laboratory within six hours of collection or cooled to not more than six degrees centigrade pending shipment (as previously required by 2.7 (c)). The second revision would require that the time between specimen shipment and receipt of the specimen at the HHS-certified laboratory not exceed 48 hours, or that the time between shipment and the screening test at the HHS-certified laboratory not exceed 72 hours. 73
# =,
a 1 9 The NRC proposes several~other minor editorial revisions to Section 2.4 in response to industry experience. These revisions do not substantially alter the intent of the original rule. .l Changes to Section 2.4 (i) would simplify the tra: king system for the courier and the 1:.boratory. The NRC proposes that collection persowel should report incidents when an individual refuses to cooperate in the testing process to an appropriate authority (Section 2.4
- (J)), as designated by the licensee, rtir than through the MRO to appropriate management.
The NRC believes the MRO reed not be a key player because refusals to cooperate are administrative concems rather than medical problems. Stglign 2.6 Licensee Testine Facility Personnel. ' A change conforming to the HHS guidelines is proposed to assure that training of licensee testing facility managers includes maintenant.e of chain-of-custody. Section 2.7 Laboratory and Testine Facility Analysis Procedures.
. Proposed revisions to this section further clarify wording cnd procedures discused in previous sections.
The NRC proposes several changes in this section that would be consistent with the recent revisions to the HHS guidelines. The NRC proposes to redt.ce the screening cutoff level for marijuana from 100 nanograms per milliliter (ng/ml) to 50 ng/ml (Section 2.7 (f) , formerly 2.7 (e)). Current testing technology is capable of supporting reliable and valid results at this level. - In add'i tion, analysis of results in nuclear industry drug testing programs shows that positive test rates (indicating increased detection) increased substantially when the 74'
_ _ _ . . . - _ ._ ._ _._ . . _ _ _ . _ ._ _ ._ _.__. _ . . ~ . _ . - . _
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- screening level was lowered to 50 ng/mi from 100'ng/ml. These proposed changes .would 1
make the NRC's FFD rule consistent with the HHS Guidelines (59 FR 29908; June 9,1994) - l L and the cutoff levels used by all other Federal agencies. This change is needed to ensure that ; licensees' specimens are tested by a process certified by HHS (any cutoff level different than the HHS-certified procen must be accompanied by appropriate QA measures). The NRC ; 3 L , proposes a revision to eliminate the requirement that test results be reported in batches. . (Section 2.7 (h) (1)). In addition to being consistent with the recent revisions to the HHS guidelines and the currect general practice, this would significantly decrease the amount of j . time required for licensees to receive certain types of test results from the laboratory, o The NRC proposes to clarify its original intent that licensees which retain split ! specimens must use a different HHS certified laboratory in cases where a split specimen is being tested for an appeal (f 2.7 (k)). The NRC was informed by HHS that requiring a i different laboratory essentially guarantees a different process for preparing the specimen , which would provide a high assurance of detection of any laboratory error or inaccuracy of l test results. In one instance, the same laboratory that produced a positive test retested the specimen during an appeal and, using the same method, made the same mistake and produced a second false positive test. The false positive was discovered in response to repeated appeals L
' by comparing this laboratory's results with the resu.ts reported by another laboratory. *~
Although suspected false positives have been extremely rare, this proposed revision would . further reduce the possibility' for recurrence of a false positive due to a lateratory error. The NRC is proposing a number of revisions to this section aimed at enhancing the effectiveness and reliability of licensee FFD program by requiring testing to determine the validity of specimens; this adaptation of a recent change to the HHS guidelines would detect n evidence of adulteration or dilution, thereby reducing the potential for subversion of the 75
- testing process. This change would also address concerns that the rule does not require the laboratories to report the results of tests, such as pH, specific gravity (SO), and creatinine, to the extent these tests are performed. Licensees have encountered various practices, such as .
adulteration and dilution,- by sub' stance abusers to avoid detection and the NRC desires to minimize the vulnerabilities in the testinF process that have been exploited. One of these nrae:s muld be to Ateitaine specimen validity. Licensees conducting onsite testing would ir ,c.g. tired !n deteimine the validity of all specimens z!!ected; this would avoid disposal of
- v. i-o.m tI<e mud lmve tv en determined invalid by the laboratory. The validity of the
.per n , , mui<t f ie ,1cten iine.I ibooigh 8.lw ndd 1 ofic: ting for specific gravity on arrival if ibe no. < iireo =.. h I;cenve'A onsiir testing fi.c'8ity or the HHS-certified laboratory ipm- a- .<y). fl.e <td requet.ts anninents on wh:ther those tea for determining
.p . e , i+ .:.,.en , ca..i.; u c t G2: 3e..iQ/.up*loaiy (pf 4, centimoc, and other ic#ts for
. ?. '.
- r. .' ..h .e
.i u . s b. 4. u uph , Md .: . pan af the co%ctir.n pro.; CSS so b- . <
4 _r ' . .n . t ,, t
,,te(t ignewinit 'f tuid v efe' dirPC( ubsetVatioll. To piucct
% i u ., e . . . m w e. . iii.. .ad in et,out the ,mt idity of a speciroco, ihe NRC is e.,f. d.m dui nu ze . r i beer .f * . m..u i a lx: outs of Tecification would be subjected
. t_.
. c c g . . .v, ...' pun.pq:. : .- , ., f it . i: nit of detection ibat the lab iratory is capable 1 p. .. .i a g, the raf:' undei stands that ibh may not be technically feasible for specimens
. om....c.. 3 .;o,w ..dutimou lu those ca>cs, the laboratuiy would not test to limit of detection
'JDD w .d . ould rqrni 14; ;pe. iiaen . conditiva. The NRC understands that some NHS-
- e.iilied hdonitoile s hve mi 1.00 much lower than the established cutoff values, while athen may not be able to achieve an LOD less than 40 percent of established cut off levels. <
i ! Theiefore, the NRC iequuts comments on the desirability of requiring that tests of specimens which are outside of specifications (i.e., show evidence of adulteration or dilution) be 76
i y-performed at the HHS-certified laboratory's LOD and depending on licensees to select d ~ laboratories capable of achieving the lower LODs and to develop appropriate quality, controls, j
- Recognizing the ability of HHS-certified labora;ories to identify drug metabolites at lower ~
concentration levels found in. dilute specimens in a forensically sound mannu, the NRC
' - believes this is an appropriate approach .to reducing the potential for incorrect conclusions -
a
- about the validity of a specimen.
- The NRC be.lieves that the information developed during these procedures would I
enable the MRO to make an accurate determination of whether a specimen of questionable validity has actually been adulterated or diluted. If the specimen has been heavily adulterated l L or diluted, specimen validity test results would indicate an obvious attempt to subvert the testing process. -lf the specimen is moderately diluted, with no drugs detected, and the worker's health habits reveal consumption of appropriate quantities ofliquids, the MRO j would determine no attempt to subvert the testing process, If drugs are detected, the MRO would conclude that the worker has attempted to subvert the testing process. p in keeping with this proposed change to reduce subversion of the testi ng process the , NRC proposes to require (in Section 2.7 (d)) that the Medical Review Officer report any adulteration or dilution evidence (excluding hydration resulting from an acceptable reason) to
. licensee management in order to enable licensee management to more vigorously pursue -
subversion attempts (Section 2,7 (h) (1), fom.:rly Section 2,7 (g) (1)). Hydration resulting
- from acceptable reasons (e.g., drinking fluids for health reasons) would be excluded because-F _this type of hydration occurs frequently, especially in warm climates. Another revision would
; add urine specimens that are determined on site to be questionable for adulteration or dilution t
L to those specimens that licensees must ship to an HHS-certified laboratory for testing (Section -
- 2.7 (d)).1 By a related revision, all specimens that have been adulterated or diluted, er that the 4.
77 l-b bi- W g- -=$t . g* 'y Myer9pTC' -'TI- 1 y- a- er #hyf - g- w --
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licensee specifies have been associated wkh personnel actions for other reasons, would be subject to long4erm frozen storage for at least one year by HHS-certified laboratories (Section = l 2.7 (i)). The NRC recognizes that these changes are minor clarifications or modifications to 4
- existing requirements and understands that many licensees are currently performing these proposed a:tions.
The NRC proposes four changes to the requirements for testinge . First, the NRC proposes that a test for d (dextro) and I(levo) isomers of methamphetamine be required for all positive tests for amphetamines (an additional two days are provided the laboratory for_- processing specimens suspected of contai n ing amphetamines) (Section 2.7 (g) (6)). Some legal drugs (e.g.,-Vicks inhaler) contain amphetamine compounds that may yield a laboratory-F confirmed positive for amphetamine use. Laboratory confirmatory tests for the d and / . , isomers are able to differentiate between compounds and to identify those positive test results 1 ~ that are the result of legal use. - Many licensees have already been using this test as further confirmation 'of positive test results for amphetamines. This proposed revision would mandate the use of this test by all licensees and be consistent with current laboratory practice described __by llHS in its Technical Advisory of March 11,1991. Second, a new Section 2.7 (f) (3) would permit multiple screening tests only in certain limited situations.' This would adopt p with some modification a 1994 change HHS made to its guidelines which is intended to be I: limit J to amphetamines to reduce the effect of possible cross reactivity due to_ structural analogs,' and to unique testing problems. However, a few licensees have expressed concem
- when they. leamed their laboratory was routinely using' multiple screening tests on all
- specimens. Multiple screening tests should not be used on a routine basi: because of the
- increased number of false negative test results that could occur. Third, the NRC is also proposing to sduce the 'ime t that licensees must wait for laboratories to provide testing results l.
t 78-
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- r. :- :
and, thereby, enable licensees to grant unescorted ac' cess to new employees and to conclude
- activities related to drug testing in a more timely' manner (Section 2.7 (h) (1)), it is the NRC .
stafrs understanding that most HHS certified laboratories can; and usually do, report negr.tive ; I i results to the licensee within 24 hours of receipt of specimens. - A laboratory-confirmed' L positive result usually requires another 24 to 48 hours; Exceptions are when a positive test; result for amphetamine requires further testing for d and Iisomers or an opiate positive requires further testing for 6-acetylmorphine (6-AM) at a few laboratories. The reduced c period of time provided to laboratories to report results assures that licensees will receive
- 4
- results in a timely manner and will reduce the time that new employees will have to wait for their unescorted access, thereby reducing costs to the licensee. Fourth, the NRC proposes to 8
require that a methamphetamine confirmatory test result contain at least 200 ng/ml of amphetamine for the result to be reported as a laboratory positive (Section 2.7 (g)). This revision would conform with a similar change made to the !!!IS Guidelines on . lune 9,1994 , (59 FR 29908). This requirement was adopted by HHS to prevent false positive 6 methamphetamine results that can be caused by chromatographic resolution problems in the confirmatory testing process. In a related matter, the NRC understands that a significant percentage of laboratory-confirmed positives for opiates are determined to be negative by the MROs based on use of e prescription medication, poppy seed consumption, no clinical evidence, or other reasons, in I several public meetings, MROs and other FFD program personnel have expressed concern that the c'urrent. opiate' testing levels are not properly targeting opiate abusers. The concern is that 4 the program is not effective in deterring or detecting heroin use (the rule requires clinical signs of abuse for the MRO to determine the test result as positive, yet heroin is frequently smoked or inhaled leaving no clinical signs of abuse), and large numbers of laboratory- , 4 - 79 - J
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confirmed positives for opiates are determined negative, which imposes an unnecessary bur
- on the MROs and costs to the licensees. - Data from eight licensees summarized in Table 3.1:
1 of NUREG/CR 5784 indicate that only 2 of 124 laboratory-confirmed opiate positives were , confirmed by MROs as positive'(both of these positive results were reported by one licensee) s These data are consistent with anecdotal reports from HHS and DOT officials and MROs. The NRC understands that the Deps.i...cr.t of Defense (DOD) has raised its screening-1 test cutoff level for opiates to 2,000 rig /ml and the confirmatory test cutoff levels for morphine to 4,000 ng/ml, codeine to 2,000 ng/ml and 6-AM (a metabolite specific for heroin) . to 10 ng/ml. The NRC is specifically interested in public comments and supporting data as to whether it should raise the cutoff levels for screening and confirmation tests for o;intes. . Should the NRC set its levels consistent with those set by the DOD and proposed by HHS on November 16,1995 ( 60 FR 57587)? Given the level. of concem for safety in the nuclear s y industry, should the NRC retain the current levels? Two revisiris related to the short term refr.gerated storage of specimens are also being , proposed (Section 2.7 (c)). This section currently requires that specir. ens that do not receive a screening test within seven days of arrival at the HHS-certified laboratory be chilled in
. secure refrigeration units. The NRC has determined through pilot experiments that at least one drug. metabolite is subject to deterioration if a urine specimen containing this metabolite is ,
4 allowed to stand for more than 32 hours at relatively high temperatures. The NRC has also i become aware of anecdotal evidence that indicates that, when specimens are shipped or stored - q
^\ , at warm temperatures, there is a potential for drug er metabolite deterioration such that specimens containing drugs or metabolites over the cutc4 level at the time they; were i -
submitted can be found to bs negatis in either streening or later confirmatory tests. The 80 1 4 r e#- . -
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I ,.3 NRC is,' therefore, proposing to require that specimens that will not receive a screening test
- and, if appropriate, a confirmatory test within one day of arrival at the HHS-certified. l laboratory be stored in a chilled condition until tested. ,
The NRC proposes several modifications that would clarify or modify requirernents in light of industry experience. These modifications do not significantly affect the rule's original intent and 'are intended to reduce unnecessary problems in the implementation of the rule.
- First, Sections 2.7 (f) (1) and (g)'(2), formerly Sections 2.7 (e) (1) and (f) (2), would be - ;
- modified to clarify that licensees using lower cutoff levels are not required to perform two-different tests at different cutofflevels, instead, they are expected to use extrapolation techniques to provide the required estimates of the number of positive test rer. sits from HHS-4 e
certified laboratories that would have occurred using the NRC cutotrlevel. Second, the NRC proposes to delete the requirement that licensees have emergency power equipment available for refrigeration units in the event of a power outage (Section 2.7 (c)). Instead, the proposed revision would require only that licensees have sorn kind of contingency measures availab'e to maintain specimens in a chilled state. Third, the NRC proposes to allow routine , I administrative tasks now assigned to the MRO to be performed by the administrative staff of 9 the MRO (Section 2.7 (h) (2)), formerly Section 2.7 (g) (2). Licensee experience has found
- that the duties of the MRO are extensive and that many of the duties prescribed in the rule i
. could be performed equally well by the MRC's staff without compromising the privacy of e
- individuals.' Fourth, the NRC proposes to make explic!t that licensee contracts with HHS-certified laboratories provide that the licensee and the NRC should be able to obtain from the laboratory all information and documentation that is reasonably necessary for the licensee s k inspection or audit of the laboratory, including, but not limited to, copies of the laboratory's
- - HHS certification results (Section ' . (n), formerly Section 2.7 (m)). In addition, this 81 4
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revision provides for reduced licensee inspection activities in those areas currently inspect under the lillS certification program. l'ifth, the NRC proposes to add to Section 2.7 (n) a provision that would permit, in the event that a licensee's lillS certified laboratory loses its certification, the licensee to use for up to 3 months an lillS certified laboratory that has been audited by another NRC licensee that shares the sarne drug testing and cutoff standards. In such cases, the licensee would be required to audit the newly contracted laboratory within three months. Sixth, the NRC proposes to revise Section 2.7 (h) (5) (fonnerly Section 2.7 (g) (5)) to clarify that the laboratories, which are now required to provide expert testimony covering drug test results, would retain the originals of the specimen chain of custody form in order to assure that evidence is available for appeals. The documents would be retained by the laboratory consistent with the proposed retention requirements in Section 2.2 (a) of the Appendix. Seventh, the NRC proposes to clarify the original intent of Section 2.7 (k) (formerly Section 2.7 (j)) with regard to the applicability of the quantification of test results to split specimens. In a related matter, the NRC considered but decided not to adopt a change to Section 2.7 (h) (3) to further clarify that the laboratory must provide quantitation of test results to the MRO when requested. Some laboratories have been reluctant to provide such requested information. Eighth, the NRC proposes to clarify that the ir.dividual must be informed of hir/her option to test the split sample (Section 2.7 (k)). Inspections have indiceed that, for various reasons, not all individuals are so informed. Nid, the NRC proposes to make explicit that all standards used to calibrate alcohol breath analysis equipmerit and equipment used at licensees' testing facilities for conducting screening tests must be current and valid for their purpose (Section 2.7 (p; 3), former!y Section 2.7 (o) (2)). The NRC has received comments from licensees regarding the receipt of out-of date calibration standards for alcohol breath analysk and regarding the inability of some screening test 82
. , o j t
- equipment to test at required levels. The NRC is also aware of the deliberate ute of expired 1
calibration standards. . The NRC also proposes to revise Section 2.7 (k) by requiring an individual's request that his or her split specimen be tested in a timely manner. Current wording of the rule does not establish a time limit for an individual to request a test of a split specimen. The proposed revision wnid permit licensees to establish a definition of " timely." but it could not be restricted to less than 72 hours from the time the individual is notined of the violation. Although recently revised HHS guidelines established a maximum time limit of 72 hours, the NRC believes licensees should be provided the flexibility to determine appropriate time limits for split specimen testing requests that meet particular demands associated with the licensee's ~ no'ification experience (e.g., notification of result occurring just before a long holiday period 1 or the individual out sick). This revision would also ensure that individuals' rights are I protected by establishing the ininimum 72 hour period within which they may make a request for split specimen analysis.
- A proposed revision to Section 2.7 (p) (3) (formerly Section 2.7 (o) (3)) would allow l use of alcohol breath analysis equipment that conforms to the September 17,1993,
- amendments to the National Highway Traffic Safety Administration's (NHTSA) Model r Specifications for evidential breath testing devices originally published in 1984. While these amendments reflect new lower evaluation thresholds for devices to measure breath alcohol, licensees need not acquire new devi:es that meet these amended standards. Breath analysis equipment that meets the 1984 NHTSA standards will continue to be acceptable in NRC FFD .o programs. i *The NRC considered a potential revision to test for agents used to mask the presence of THC and other drugs. An. analysis of specimens producing negative screening tests'to
.i . l 1
i assure that they do not contain agents that mask the presence of THC and other drugs could li be specified by rule. Products that can be added 30 urine as masking agenti are currently available and tests for these products are currently used by some laborateries, Testing for ! I these products would increase the detection of attempts at subverting the testing process. l While it has decided not to propose this revision et this time, the NRC invites public comment i on both the need for and the resource impact of such a requirement. The NRC has received requers from several licensees and vendors to permit the on-site use of non instrumented qualitative immunoassay methods that involve the use of inexpensive, disposable devices. Convenience and speed in obtaining results appear to be the i main advantages of these devices. Such testing does not use laboratory analysis techniques, can be performed quickly, and can produce virtually immediate results. These compact and I portable teiting devices show promise as a quick and easy method for testing in certain circumstances such as physician's diagnostic needs when the presence of drugs or alcohol can affect what treatment is suitable for emergency room patiets. These testing devices may also be well adapted to some criminal justice applications, roadside esting, or testing in remote locations. They are generally able to identify the five drup or drug metabolites of concern to j the NRC, ; While Part 26 does not currently preclude the use of such non instrumented devices for screening tests, tr.e NRC is aware that there are several technical variables involved in the use ; of these devices that may prevent them from achieving the high levels of specificity, accuracy, . j and repeatability demanded in licensees' FFD drug testing programs. Temperature and barometric pressure can aber the araount of urine being tested and the repeatability of the test. Temperature variations may affect the teactivity of the chemical reagents and indicator strips
- being used. These effects alter the amount of urine being tested and the repeatability of the L :
84_- l 1 u__ ... . . . _ . . . _ ; L ._. . ._n .. ._ .s . _ _ . - . _ ~ . . - . . . , . , _ _ _ - a.. ... ,.,,,.r._, . J ._ _d
test. The NRC's concem is whether these types of technical variations will have suf0cient impact to alter the specincity, accuracy, and repeatability of the test results. The NRC is concerned that the use of such devices may lead to a number of false negative screening test results. (The concern for false positive screening test results is minimal since all positively screened specimens must be tested at an lillS certified laboratory and any positive results from the laboratory followed by a review of the results by an MRO.) The Commission believes that the use of testing devices that might increase the number of false negative screening test results is not consistent with the goals of FFD testing or to the credibility of the program to those subject to testing. The NRC is also concerned that there are not suf0cient procedural safeguards currently
- in place that would ensure reliably accurate screening test results if these non instrumented devices were to be used by licensees. There are, for example, no quality control procedures known to the Commission that could be used to validate the results produced by the use of these devices, nor is there any mechanism in place to validate industry wide results over time.
For example, accurate tests at the beginning and end of a batch of specimens tested with an instrumented test would indicate all specimens in the batch we accurately tested. On the other hand, " batch" testing with these non instrumented devices is probably not feasible. Littewise, the potential for subversion that could be introduced by the use of these devices has not yet been adequately investigated or addrc sed. Requirements may need to be developed to protect an employce's right to privacy and to minimize the chances for subversion of the testing process. No procedural safeguards exist in the text of the rule or in Appendix A that I would address opportunities for subversion of the testing process which may be created by the use of these new devices. i 85
i
- l Given the uncertainties surrounding the potential use of non instrumented testing devices, the NRC would prefer that these devices not be used for screening tests in licensees
- i FFD programs at this time. The NRC is aware that 1111S has been mandated to invest gate ;
the accuracy and reliability of these devices. The NRC will monitor the liffS investigation and continue to pursue its own inquiry into the feasibility of the use of these devices for FFD screening tests. As part of this effort, the NRC will determine whether new guidelines, quality assurance procedures, and performance standards that would govern their use should be added to Part 26. To aid in this effort, the NRC invites public comment on the advisability of its creating guidelines, procedures, or standards for non instrumented testing devices. The NRC would welcome specific recommendations as to how Part 26 could be amended or other means that would address the concerns discussed above and other issues surrounding the use of such devices. Alternatively, the NRC invites public comment on the advisability of its waiting until procedures or standards goveming the use of non instrumented testing devices are developed by other agencies and then evaluating and adapting those standards to the nuclear power industry's requirements. Should there be a Conforming Products List for these devices similar to that published by the NilTSA for evidential breath measurement devices, and who should administer such a program? The NRC also would be interested in learning under what conditions, if any, would the use of non instrumented drug testing devices produce cost savings as compared to licensees' current means of screening. The NRC notes that Section 2.7 (h) (4) (formerly Section 2.7 (g) (4)) requires that lillS-certified laboratories transmit drug test results to MROs in a manner designed to protect the confidentiality of that information, in order to promote the efficient administration of FFD programs, it is the Commission's policy that FFD program personnel can assist MROs in 86
- l i
, l I the receipt and processing of the laboratory repons. While some programs have chosen to l require that test results be received only by their MROs, others have allowed other program personnel under the supervision of an MRO to receive the results and forward them to the hfRO. The NRC believes that both approaches are acceptable as long as the procedures for receiving and handling test results within the program are designed to preserve the confidentiality of the test results and actually accomplish that purpose. The NRC reiterates that a test result reported u a confirmed positive by an liliS-certified laboratory must not be considered a violation of a licensee's FFD policy until such result is reviewed by the hiRO to determine ifit constitutes evidence of such a violation. Therefore, the procedures through which the hiROs receive test results from tills certified laboratories should contain explicit safeguards against improper disclosure of the report and premature actions such as the laboratory. confirmed test result being recorded in the employee's personnel file, an employment action being taken, or licensee management being notified of the positive result until aller the hfRO has determined that there is not an acceptable medical explanation for the positive result. Section 2.8 Ouality Assurance and Ouality Control. A proposed revision to Section 2.8 (b) would clarify that the cunent requirement that licensee testing facilities " process" blind performance specimens means that licensees conducting on-site testing must perform an immunoassay test on all such performance specimens before they are submitted to the liliS certiGed laboratory. This revision is intended to make clearer the NRC's original intent regarding this requirement. A further revision would make explicit the requirement that licensees must evaluate the results of their 87
4 IIHS-certified laboratory's testing of the blind performance test specimens and a sampling of specimens screened as negative submitted by the licensee and take corrective action as appropriate. The NRC, after consulting with SAMHSA, proposes an adaptation of recent changes to the HilS guidelines for blind performance test specimens (Section 2.8 (c)). As HHS did with its guidelines, the modifications would reduce the percentage of blind performance specimens, reduce the proportion of blind performance tests relative to the total number of tests submitted, and reduce the maximum required number of blind performance test specimens. These changes are intended to ensure that the number of blind performance test spechnens required to be submitted are adequate to assure quality in the testing process and particularly in the HlfS certified laboratory. The NRC proposes to reduce the percentage of blind performance tests from 50 percent to 20 percent for the initial 90 day period and from 10 percent to 3 percent after the initial period, consistent with changes made to the HHS guidelines and the Department of Transnortation's rules. The maximum number of blind performance test specimens required to be submitted both in the initial 90-day period and after is also lowered in the proposed revision. Ilowever, the NRC believes a maximum number less than that established by the HilS guidelines would assure adequate quality in the testing process. Whereas HHS lowered the maximum number of blind specimens to be submitted during the initial 90 day period from 500 samples to 200, the NRC proposes a further reduction to 100 specimens. The maximum number of specimens submitted thereafter during each quarter was reduced from 250 to 100 by HHS; NRC proposes a further reduction to 25 blind specimens per quarter. Because the NRC permits on site testing and very few specimens with unconfirmed positive test results would be submitted to laboratories at these sites, the NRC, in consultation 88
with SAMilSA, proposes that there should be a minimum number of blind specimens (10 per quarter is recommended) to ensure that a sufficient number are submitted to assure the quality of the testing process. The NRC intends that utilities with multiple collection sites submitting specimens to the same llHS certified laboratory meet the percentage requirement for each collection site. Ilowever, a licensee may combine the number of specimens collected from its multiple sites to meet the total minimum requirement for all collection sites. That is, if one or more of the utility's collection sites and the corporate ofYice contract with the same laboratory, they may pool their number of regular test specimens to meet requirements for the minimum number of blind performance test specimens. The NRC expects that blind specimens will be submitted to the laboratories from each collection site and that submission will be uniformly distributed throughout each quarter to correspond with the submission rate for other specimens. The NRC also proposes to lower the percentage of blind performance test specimens which would be blank and raise the percentage which would be positive for one or more drugs (Section 2.8 (c)(3)). Increasing the percentage of positive specimens would help offset the reduction in the minimum percentage requirements for blind performance test specimens and would assure that an adequate number of positive performance tests for each drug are submitted for goality control. Also, the NRC proposes that 10 percent of the positive blind specimens be appropriately adulterated or di!;ted and " spiked" to 60 percent of the cutoff value to challenge the laboratory's ability to determine specimen validity as proposed in Section 2.7 (e) of the Appendix. The third proposed revision would clarify that licensees must investigate any testing errors or unsatisfactory performance identified throughout the testing process or during the appeals process (new Section 2.8 (f), formerly Section 2.8 (c) (4), (5), and (6)). The NRC 89
v , , intended, in the original rule, that testing or process errors discovered in any part of the program, including the appeals. process, be investigated as an unsatisfactory performance of a test. Thorough investigation and reporting of such test results will continue to assist the NRC, the licensees,1111S, and the HliS certified laboratories in preventing future occurrences. De NRC also proposes to clarify Section 2.8 (e) (2) by modifying the reference to
the initial 90 day period of any new drug testing program" te read "the initial 90-day period of any contract with an }{}{S certified laboratery." The clarification would help assure that intensified quality testing is performed during the initial phase of testing by any new laboratory, as originally intended. (See previous discussions in item number 10.5.6 of NUREG 1354 and item number 4.1$ of NUREG 1385.)
The NRC proposes revising Section 2.8 (c)(1) by clarifying the criteria that licensees must follow when purchasing blind quality control specim~ns. Currently requirements only ensure that blind quality control materials be purchased from labs certified by fills or a lillS-recognized certification program. Due to the fact that not all suppliers of blind quality control i materials adhered to uniform standards for preparation and certification, unacceptable blind quality control specimens have been used. These unacceptable blind quality control test results, e.g., false negatives or false positives, lead to increased costs and lowered efficiency because of additional tests and follow up actions necessary to validate the results of previously tested saual specimens. More importantly, the uucceptable results may tend to cause loss of confidence in the testing process. In order to eliminate these problems, the NRC proposes to explicitly state the criteria, as lillS did in its recent revisions to its guidelines, in order to clarify for licensees the standards for blind quality control materials and make the rule consistent with existing practice. 90
. c- ;
, t 4' holan 2.9 Paa=*ian and Review of Resuks. e The NRC proposes a number of revisions to this section to clarify the original intent ? h 4 c 'he rule. f ' Section 2.9 (d) requires the MRO to determine if there is clinical evidence of opiate l abuse before verifying a test result to be positive for that drug (meaning a clinical examination of all persons whose specimen was te *orted by the laboratory.as positive for ' taurphine or codeine). The NRC has become aware that some MROs believe that the [ opponunity for an individual to discuss a positive test result and related matters in a telephone conversation rather than at a face to face interview is sufficient to comply with this section. Providing the opponunity for only telephone conversations in some situations may not be. I adequate, panicularly in cases where opiate use is in question. FFD experience demonstrates
+
i- that personal, face to face, contact between the MRO and the subject individual can play an imponant part in arriving at fair and defensible judgments as to whether a violation of FFD , ' policy has occurred. This process will be funher clarified in the near future by HHS through ; revisions to its Medical Review Officer Manual. The NRC proposes to clarify that the standards applied to the determination of whether 1 clinical evidence of opiate abuse exists would include a range of evidence, including . substantial evidence oflack of reliability and results inconsistent with ingestion of food or medication.- Some MROs have interpreted this section of the regulation as restricting the t types of evidence they should consider (Section 2.9 (d)), in some cases resulting in " pro fonna" rejection of all laboratory positives for opiates. ; 4 ' With regard to legal drugs, the NRC proposes to remove the requirement that Medical l l Review Officers determine whether there is clinical evidence of unauthorir.ed uE of over; 91 i
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j i counter and prescription dmss (Section 2.9 (d)). This requirement has created dimculties for ; Medical Review Omcers because there is little guidance that can be developed regarding what ; i constitutes clinical signs of abuse for these suba~*s j l L The NRC notes that during the first five years of program operations, there has been j programmatic inconsistency in MROs' decisions concerning the abuse of legal drugs, such as l the use of drugs prescribed for one's spouse. This inconsistency has resulted in significant j I variance in management actions taken la response o this type of dmg use. The NRC is not proposing a revision to this section. Instead, the NRC expects MROs to use prudent judgment j in dealing with those situations which raise significant FFD concerns. I The NRC proposes clarifying 'that a medical determination of fitness be conducted ), 1 (Section 2.9 (g)) in the following cases: (1) where there is a reason to believe inat on duty ! i impairment may exist (whether or not there is an FFD policy violation), (2) in the evaluation- l of all for-cause tests results, (3) before making retum to-duty recommendations, (4) before , l granting unescorted access to the protected area when a record of a prior FFD violation exists, ' and ($) if a history of substance abuse is otherwise identified. The licensed physician or i Medical Review Omcer is to report to licensee management both determinations of FFD i violations and determinations of any condition under which an individual may not be able to safely and competently perform his or her duties. These requirements are intended to increase assurance that a medical evaluation is performed for circumstances where fitness may be ; questionable. The NRC wishes to emphaslae that the determination of an impairment problem
- that does not constitute an FFD violation must not result in' punitive action toward the individual.
The NRC proposes to require Medical Review Omcers to review BAC readings ; between 0.02 percent and 0.04 percent and to extrapolate the results of breath analysis for ; 92-
,, . ;;, _ - ; i
alcohol, or GC analysis of blood, back in time when appropriate (Section 2.9 (h)). This would ensure that individuals who can reasonab!y be concluded to have had a BAC at or above 0.04 percent while on duty will be found to be in violation of the FFD policy. The NRC proposes to revise Section 2.9 (c) by clarifying what constitutes a " timely" request by an individual that an aliquot be reanalyzed. This would be an adaptation of the timeliness standard for testing split specimens recently adopted in the HHS Ouidelines. However, under the HHS approach the split specirren " belongs" to the donor and the primary specimen " belongs" to the employer; therefore, the Wi3 guidelines are silent on timeliness for reanalysis of the primary specimen. Current wording of this paragraph in the NRC's rule requires an MRO to authorize a reanalysis of the original aliquot on the timely request of the individual tested. This ambiguity could be problematic for licensees who must determine how
" timely" such a request actually is. The proposed revision would permit licensees to establish a definition of " timely", but it could not be restricted to less than 72 hours from the time the individual is notified of the violation. The NRC believes licensees should be provided the flexibility to determine appropriate time limits for requests for retesting specimens that meet particular demands associated with the notification of the worker (e.g., notification occurring just before a long holiday period or extended illness), yet this revision would also ensure that individuals' rights are protected by affording them a minimum of 72 hours within which they may make a request for reanalysis of the specinien. In addition, the NRC is allowing licensees the flexibility to dispose of test results, based on scientific insufficiency, after three years.
The NRC proposes adding a new Section 2.7 (p) (6) and amending Section 2.9 (b) by restricting the types of arrangements that can exist between the MRO and the HHS certified laboratory or the operating contractor of an on site testing facility. The NRC proposes to 93
I require that the MRO not be an employee, an agent of, or have any financial interest in the laboratory'or on site testing facility operator for khich the MRO is reviewing drug testing 4 results. Similarly, the laboratory and on site testing facility operator shall not have any
- relationship with the MRO that may be construed as a conflict ofinterest. These restrictions are consistent with recent changes to the HHS guidelines and the NRC believes that they will assist in eliminating any conflict of interest between the MRO and the contract laboratory and on site testing facility operator that may affect the impartiality and objectivity of the MRO in
.-reporting testing deficiencies or errors to licensee.
I Section 3.2 Individual Access to Test and I sharatory Certification Results. 1 The NRC proposes to delete this section and incorporate relevant portions ofit as Section 26.29 (c). . i Section 4.1 Une of HHS-certified Laboratories. The NRC proposes to add a caution, upon the advice of SAMHSA, that the HHS certification process applies only to the drugs and cutoff levels specified by HIIS and that the i defer. lbility of the results of tests at more stringent cutofflevels than timse required under
. HHS guidelines, for analyses of blood specimens for alcohol, and tests for substances other
- than the 5 covered under HHS guidelines depends on appropriate measures by licensees to l assure that the reported results are valid.-
Environmental Impact: Categorical Exclusion g
- 94 .,,.,.m.- nrw-wvy,wrr-., ., ., ,,-w. - , * - - ...,,=.-w, . - . . , e ,- -m w ,, .m y,w w w w vy-- --,--rwr-w-yv ,w-wsyw.---w,w--er -,
O , O The NRC has determined that this proposed rule is the type of action described as a categorical exclusion in 10 CFR 51.22(c)(2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed rule. Paperwork Reduction Act Statement This preposed rule amends information callection requirements that are subject te the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the information collection and paperwork requirements. The proposed rule will relax existing information collection requirements and will contain new infor.tiation collections. The overall effect will also reduce existing information collection requirements, and the overall public burden of this collection ofinformation is expected to be decreased by 170 hours per year per site. These estimates for both reduction and addition to burden include the time required for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. The U.S. Nuclear Regulatory Commission is seeking public conenent on the potential impact of the collection of information contained in the proposed rule. Comments to the OMB on the collection of information or on the following issues must be submitted by (insert date 30 days after publication in the Federal Register).
- 1. Is the proposed collection ofinformation r.ecessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?
95
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- 2. Is the burden estimate accurate 7 i
- 3. Is there a way to enhance the quality, utility, and clarity of the information tc bc l collected?
i
- 4. How can the burden of the information collection be minimized, including the use !
.1 , 3 of automated collection techniques? Send comments regarding these burden estimates or any other aspect of this [ l $ collection of information, including soggestions for reducing the burden, to the Information ] and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Cornmission, ! Washington, DC 20555 0001, and to the Desk Officer. Office ofInformation and Regulatory. I i Affairs, NEOB 10202, (3150 0146), Office of Management and Budget, Washington, DC j 20503. ! The NRC may not conduct or sponsor, and a person is not required to respond to, a { collection of information unless it displays a currently valid OMB control number. ;
.. i n ;
Regulatory Analysis The Commission has prepared a draft regulatory analysis on this proposed rule. The ; analysis examines the benefits, cost' savings, and costs of the alternatives considered by the ; Commission. The draft analysis is available for inspection in the NRC Public Document i Room,2120 L Street NW. (Lower Level), Washington, DC. Single copies may be obtained ; from Loren L. Bush, Jr., Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory
- Commission,- Washington, DC, telephone (301) 415 2944, i r
E- _ 96 ,
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Regulatory Flexibility Act Cenification I in accordance with the Regulatory Flexibility Act of 1980, (5 U.S.C. 605(b)), the ) Commission certifies that this rule will not have a significant economic impact on a substantial number of small entities. This proposed rule affects only the licensing and i i operation of nuclear power plants and activities associated with the possession or trouportation of Category I material. The comp 3nies that own these plants do not fall within l 1 the scope of the definition of *small entities" set forth in the Regulatory Flexibility Act or the size standards adopted by the NRC on April 11,1995 (60 FR 18344 10 CFR 2.810). .l i Backfit Analysis i This proposed rule would modify a prior Commission position by adding new ; requirements and rescing other requirements. The modifications are intended to improve the i effectiveness of the rule in the lighi of demonstrated program performance and lessons learned f since the implementation of the rule and to enhance overall program integrity. Some of the modifications would be made to make the rule consistent with modificaticas to the nat ial standards on drug testing promulgated by the Department of Health and Human Services. Other modifications are intended to prevent subversion of the te. sting process (examples include: limiting the tirne between notification and testing, using a narrower temperature range to make it more difficult to submit a surrogate sample), funher ensure the accuracy and integrity of tes?ing (examples include: determining specimen quality, using a narrower temperature range, and requiring timely shipping and testing of specimus to prevent degradation of specimens), clarify actions for remnval and retum to senice, incorporate 97 i m,,..,-.,w--,--._-+- , _ , - , - m a ,... e .,_ _ _--... _ ,_.-,,,,_. w . - u .._.._----a--._,..-;-,-. _ .a - . ;
advances in technology (example: measures to eliminate " false positives" from legitimate use of amphetamines), and protect individual rights. The proposed changes are, for the most part, minor program adjustments or clarifications and do not alter the Commission's original intent. Furthermore, the modifications would better achieve the level of assurance in the accuracy of results and the integrity of the testing process which was originally intended. The NRC believes that some of the changen are needed to minimize the vulnerabilities that are being exploited by substance abusers. To facilitate public consideration of these proposed changes, the Commission has placed the proposed rule changes into the three groups appearing below. The first group consists of those changes intended to conform the rule to the HHS Mandatory Guidelines that have been modified since the rule was last revised. Subgroup IA lists those changes intended to make the NRC rule compatible with the HHS Ouidelines as revised. Because the Commission continues to desire to permit more stringent programs than set forth in the HHS Ouidelines, it was necessary to adjust some of the new HHS requirements to meet the needs of the nuclear power industry. These are listed in subgroup IB. The second group consists of those rule changes that would reduce licensees'
- regulatory burden. Subgroup llA lists those thanges in this category for which the Commission was able to calculate specific monetary savings to licensees. Som, of the proposed changes in the second group would provide licensees with FFD program administrative flexibility that would provide some indeterminate reduction in burden. These changes are found in subgroup 11B.
Group 111 contains several proposed revisions that the Commission believes to be worthwhile and necessary to better accomplish the FFD rule's objectives. Subgroup lilA 98
consists of those proposed rtvisions that are particularly important to achieving the rule's objectives. These include revisions designed to reduce the incidence of subversion of drug and alcohol testing and to enhance the rule's protection of the rights of workers subject to tc t rule. - The proposed changes appearing in subgroup filB would serve to clarify the rule's' existing requirements, reduce ambiguities that have often resulted in interpretative debates, and make other administrative changes. Some of the Group ill changes, such as establishing a more restric'ive temperature range, would restI t in a departure from the HHS guidelines. i Whether the proposed changes would, considered as a whole or individually, piovide a substantial increase in overall protection of the public heelth and safety is a significant question. NRC staffis of the preliminary view that these changes, although desirable, would l 3 not provide a substantial increase. Public comment is specifically requested on this question of substantiality. If the Commission were unable to conclude at the final rulemaking stage that these f changes would provide a substantial increase in overall protection, the fiuther question arises whether the rule should nevertlieless go forward. One approach to continuation of the rulemaking would be to view the rule as a whole and to conclude, if warranted, that the rule's . cumulative effect is to ease licensee burdens or leave them essentially the same, rather than to ; increaae them. This would be consistent with an interpretation that the backfit rule does not apply to relaxations of requirements. However, the mandatory nature of the proposed rule, :
~
and effects on interested persons other than licensees, could present complicating factors. Alternatively, the question is presented whether those subject to the rule would decide not to object to the new requirements in view of a perceived overall benefit and, if so, whether non. objection could be grounds for not applying the backfit rule. The basis here would be that the !
- , - - . - . . - - - . . . -- - . - . . . = - - -
backfit rule was s.olely directed at controlling objectionable impositions of additional requirements. Public comment on these considerations is specifically invited. LIST OF PROPOSED CHANGES TO 10 CFR PART 26 i Group in Adoption of National Standards A. Changes to ensure cornpatibility with the HHS Guidelines as revised in June 1994. G26.241 (f) MRO to report FFD policy violation in writing (g) Ensure all collected specimens are tested and resnits are reported Section 1.2 of Appendix At
- Delete definition of permanent record book Section 2.4 of Appendix At (d) Courier signature net needed on chain of custedy documents (g)(4) Eliminate requimment that tester request list of medications prior to specimen collection (g)(9)+(24) Eliminate the requirement for a permanent record book (g)(10)+(IS)+(23)+(24) Allow accompaniment or obsemtion by person of same gender, other than a collection site person (g)(I!) Clarify fluid intake to assist in providing specimen (g)(13) Specify the temperature range for an acceptable urine specimen in whole numbers (i) Clarify requirements concerning use of second, tamper evident shipping container 100
Section 2.6 of Appendix As .
. Assure training of licensee testing facility managers includes maintenance of chain of custody Section 2,7 of Appendix A:
(f) Lower the cutoff level for marijuana screening tests from 100 ng/ml to 50 ng/ml (g) Modify the criteria for determining that a specimen is p>sitive for amphetamines (g) Require testing for d and / isomers of amphetamines (h) Eliminate batch reporting of results (p) Laboratory shall not have a conflict of interest with licensee's MRO Section 2.8 of Appendix A: (c) Require blind quality control materials meet standards for preparation, certification, and stability Sectica 2.9 of Appendix A (b) MROs shall not have a conflict of interest with certified laboratories Section 4.1 of Appendix A (b) Note that licensees need to take appropriate measures when testing outside HilS certification proecss H. Changes to conform HHS Guidelines resisions to the framework of the original FFD rule. 626.24: (d)(1)+(g) . Require licensees to ensure that all collected specimens are tested and results reported Section 2.4 of Appendix A: 101
1 (gX11) Reduce required minimum quantity of each urine specimen from 60 ml , to at least 30 ml (Where licensee chooses to test on site, split specimens, or to test for additional drugs. more than 30 ml will be necessary) i Section 2.7 of Appendix At (c) Validity of specimens,i.e., tests for adulteration and dilution at HHS laboratory (f) Pamit multiple immunoassay (screening) tests for the same drug or drug class (k) Clarifications to split specimen collectior, and dispatch procedures and laboratory ' selection (k) Minimum time for requests by individuals to have split specimen tested at another ilHS laboratsry Section 2.8 of Appendix A () Feduce the maximum number and percentage of blind performance specimens to be submitted per quarter but require a minimum
- Section 2.9 of Appeadix As (c) Minimum time for request by individual for reanalysis of original specimen added Group II: Reduct9m in Burden A. Changes with quantitative monetary benefits.
626.2: (f) Eliminate duplicate testing under multiple programs
$26.20:
(f) Credit for unescorted access status granted by another licensee (26.21: (b) Refresher training intervals extended from 1 to 2 years F (b) Acceptance of generic portions of training provided by another licensee 102
0 4 0
$26.22t j (c) Acceptance of generic portions of training provided by another licensee 626.24:
(a)(1) Flexibility in pre access test'ng . i
' - tents witnin past 60 days may be considered pre access tests if they meet ;
the standards of Part 26 ) I - access may be granted peni!.ng test results for individuals covered by an ; acceptable FFD program for 2 consecutive weeks in the past 6 months-I
- no pre access test for ' hose transferring from another program who have been covered by an FFD program meeting the requirements of Part 26 ,
for 30 of the past 60 days (a)(2) Persons off site and unavailable when chosen for random testing may be i tested when next on site , (a)(3) People tested for cause for alcohol can retum to duty while awaiting urinalysis results (a)(5) Clarify existing testing requirements for persons unavailaNe for testing for short periods and insure consistency with the access authorization - program E (e) Limit time between notification and specimen collection (26.27: (a) Fitness history need not be obtained for those covered by other programs or absent for 30 days or less 326.71: . (d) Reduce frequency of program performance reports 103
. . _ . _ .=, . - - - . _ _ _ _ _ . _ _ . . . - _ _ _ _ . _ . _ _ . . _ .- _ _ .-
626.80: (a) Change to performance based audit as the basis for reducing required frequency Section 2.2 of Appendix A (a) Permit prompt destruction of chain of. custody forms showing negative test results Section 2.3 of Appendix A
- Extend reinvestigation interval for FFD program personnel frorn 3 to 5 years Section 2.4 of Appendia A (g)(18) Eliminate second breath specimen when test sho">s no alcohol .
Section 2.7 of Appendix A (e) Test questionable spe.:imens to level of detection (h) Permit MRO staff to perform certain support functions (n) Eliminate need to audit areas covered by 11115 inspections B. Changes that provide greater flexibility and indeterminate monctary benefits. $26.2: (e) Reduce requirements during decommissioning $26.22: (c) Refresher training intervals may be extended from 12 to 36 months if written exam is given every 12 months 326.24: (a)(3) Provide flexibility in timeliness of for cause test > (f) MRO to complete review as soon as practicable and inform management if determination of test result is delayed more than 14 days after collection instead of completing review and notifying within 10 days after screening test (i)- Flexibility for unusual medical conditions 104 l
r
$26.27:
s . (a) Certain aspects of fitness history to be limited to 5 years (a) Power reactor licensees usually need not obtain statements responding to activities related to possession or transport of Category I nuclear material r (c) Allow records of FFD violations to be dinarded after 5 years ; l i
$26.29:
4 ! (b) Pemilt provision of personal informa4n for judicial or administrative proceedings j i ~ initiated by the subject individual . . l (b) Permit provision of personal information to contractors and vendors j
. i Section 2.2 of Appendix At (a) Reduce time for retention of chain of custody forms showing violations ,
t Section 2.4 of Appendix A (g){l3) Allow licensees to set temperature range within rule limits (g)(24) MRO or other derignated medical person can authorize an observed 'm collection i (j) Flexibility on licensee intemal reporting and actions when individual fails to cooperate . Section 2.7 of Appendix At 4 (c) Flexibility in means of keeping specimens chilled (f)Mg) When licensee uses more stringent cutoff levels, tests at level set by the rule can be calculated and need not be conducted
. (h) = Reduce time for laboratories to report results -
(n) Flexibility provided if lab loses certification ; (p) Flexibility to use old or new NHTSA standards for breath analysis equipment I 105 _ . ~. _, _ . _ _ , , - _ . .- ~ _. - . _ . _ . _ _ . _ _ _ . . _ . _ _ . _ _ _ . _
Section 2.8 of Appendix A (f) Allow disporal of records of investigative findings after 3 years Section 2.9 of Appendix A: (d) Delete requirement for hiRO determination of clinical evidence of legal dmgs (i) Allow disposal of records of negative test results, based on scientific insufficiency, after 3 years i Group Ill Olber Worthwhile Changes A. Improvements based on experieners that the NRC believes are needed and proposes to adopt. {26 24: (a)(5) Require return.to duty testing after extended absences or denial of access Require onsite testers to determine validity of specimens on site (d)(1) (h) Require back calculations for BACs between 0.02 cnd 0.04 {26.27: (b)(3)+(4) hiinimum sanctions for positive test for alcohol or the use of alcohol within the protected area
$26.28:
- Assure that appeal rights cover all types of violations, including confirmed positive test results from applicants for unescorted access and determinations of subversion
- Assure that relevant records are corrected if appeal is successful
{26.29: (c) Assure provision of copies of records to individuals upon written request 106
Section 2.4 of Appendix At (g)(13)+(IS) More restrictive temperature range for an acceptable urine specimen (i) Laboratory must receive specimens within 48 hours of shipment l Section 2.7 of Appendix A (d) Specimens questionavne for adulteration or dilution at licensees' testing facilities must be shipped to liHS laboratory for testing (c) Require onsite testers to determine v'lidity of specimens on site B. Clariflestions to existing requirements, changes to reduce interpretive dehairs, , and administrative changes which are also propmeil. 626.2: (a) FFD program personnel to be covered by if0 rule
$26.3:
- To support other rule changes, revis. c Ating M~irior. . mu. ,.+ Mimoons and relocate some definitions from Section L2 of Appien& \.
626.7: New section ensures communications are .sent to Docunvnt l'..no J Dc.sk 526.8 (c) Section regarding burden estimates deleted 526.20:
- Minor clarifying and conforming edits (introduction, (c), (d), (e) (2))
(a) Offsite involvement with drugs, subversion of the testing process, and refusals to test added to policy statement
. (a) Clear and concise policy statement must be readily available (a) Policy must address impairment from legal drug use 107
0 (d)(3)+(4) ~ Policy must specify actions to be taken for subver. ion and refusal to i provide a specimen Declaration of fitnen to perform tasks assigriod when contacted for call- l (eXI) 4
.In (f) Statement regarding Commission's rigF. to review licensee policy is deleted 1
$26.21:
(a) Minor administrative and clarifying t. lits i l 326.22: l
-(c) Supervisory training for licensee employees must be completed as soon as feasible -
following assignment to supen'isory duty 4 (c) Supervisory training for contractor employees must be completed no later than 10 days following assignment to supervisory duty i- $26.23: (a) Clarify that persons with a known (to the contractor or vendor) history of ! Substance abuse must not receive assignments to the protected area without the knowledge and consent of the licensee 626.24: j (aXI) Specify that all testing prior to granting unescorted access is to be called t pre access testing Clarify that negative pre access test result must be obtained prior to ; (aXI)- a: cess (aX2) - Random testing must be conducted on weekends, backshifts, a:xt :- holidays
, f 108
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, . _ . - , _ , . . . r.M,.....--..,..,.~., ,_,,v-., ..r,-.,,,_-. ~,
l Individuals selected for random testing during an absence of 60 days or (a)(2) more to be tested cnly once to meet both random and return to duty I testing requirements (see i 26.24 (a) (5)); tests to be reported as random l (a)(3) Clarify conditions that initiate for cause test (a)(3) Ensure removal of unHt persons and determination of Stnest prior to return to duty (a)(4) Relocate follow up testing equirem:nts from ( 26.27(b)(4/5) and clarify testing is to be unpredictable and tailored to medical history . (a)(4)i-(c) *(d)+(f) + (g) + (h) Minor clarifying edits (h) Clarify that blood testing for alcohol is for purposes of appeal . (h) Clarily that any detec.able qu.intit) of alcoholin a blood specimen may be considered to ileterinine FFD violation yM.25;
- C'arify that EAPs must he designed to achieve early intervention and must assure con 6dentiality
#26.27:
(a)+(b) Clarifying and conmtming edits (b)(1)+(3)+(5) Clarification of requirements with re.spect to access denial. removal, and return to service (b)(2) Conforming change regarding the threshold for alcohol policy violation (b)(3) People suspended must still be covered by behavioral observation, chemical testing. and sanctions for violations E
(c)' Clarify that acts of subversion must be violations of policy and result in denial of unescorted access for 3 years and that the specific cause for removal must be provided in response to_an inquiry. (d) Clarify licensee handling of NRC contractors believed to be unfit {26.28:
- Clarify that the appeals process must be objective and conductn. by pe-sons not associated with the FFD progran
- Clarify that an mdividcal may submit additional relevant information
{26.29: (b)+(c) Clarifying and conforming edits
$26.70:
(a) Clarifies the records that NRC may inspect
$26.71:
(b)+(c) Conforming edit (d) include number of subversion attempts by type in program performance repons
$26.73:
4 (a) Conforming chango (a)' Provides additional examples of significant FFD events {26.S0.: (c) ' Conforming edit Section 1.! of Appendix A:
- Minor clarifying edits Section 1.2 of Append;a A:
Delete terms defined elsewhere in Part 26 or relocated to 0 26.3 110
0
- Add definition of limit of detection (LOD)
Section 2.1 of Appendix A: (a) Conforming editorial changes (b) Conforming editorial changcs (c) Minor edit , Section 2.2 of Appendix A: (a)+(d) Minor and conforming edi s Section 2.3 of Appendix A: -
- Minor clasifying edits
- Fitness for-duty program personnel tested by independent personnel to the extent practicable Section 2.4 of Appendix A:
(f) Minor clarifying changes (f) Current or previous specimen that fails to meet normal standards constitutes a reason to require observed testing (g) Minor clarifying changes (g)( 14)+( 15)+( 18)+( 19)+(20)+(23)+(24)+(27) Conforming and clarifying changes (g)(23) Require secure scaling of specimen bottle (h)F(i) Minor clarification of scaling and labeling requirements (i) Continue to require specimens to be shipped to HHS laboratory or cooled within 6 hours of collection as previously required by { 2.7 (c) (i)+(j) Conforming changes Section 2.5 of Appendix A:
- Minor clarifying edits
~l11
6 Section 2.7 of Appendix A: (b)+(d)+(f)+(g)+(h)+(i)t(k)+(1)+(m) Minor clarifying edits (c) Require chilling or testing within one day of arrival at HHS laboratory' (d)' MRO to report adulteration or dilution to management immediately (f)+(g) Standards for BAC established (h) Evidence of subversion must be reported by HHS laboratory (h) Laboratory retention of o.iginal chala of custody form (i) Specimens associated with subversion te be placed in long-term storage (j) Retesting of adulterated or diluted specimens need only confirm specimen not . valid , (m) HHS laboratories must have blood analysis capabilities (n) Specify that licensee contracts with HHS laboratories will assure that copies of records are available to licensees and NRC inspectors (p) Calibration standt.rds (for calibrating equipment used to test for alcohol and screen for drugs) must be current and valid (p) Two year retention period for laboratory procedure manuals after end of contract with licensee _ (p) Licensee to retain latest testing procedure manual until it is no longer performing onsite testing Section 2.8 of Appendix A: 4
- (a)+(b)+(E)+(e)+(f) Minor clarifying and conforming edits (b) Laboratory results on blind performance specimens must be evaluated and approptiate corrective actions taken l
- 0) . Change the proportion of blank and positise blind performance test specimens l
l 112
(c) - Assure regularity of submission of blind test specimens (e) - Adulterate or dilute and spike some blind performance specimens . (e) Specify that initial %-day period for blind performance testing rate applies to all new contracts with HHS laboratories (f) Investigation of.esting process errors and inclusion of report of action taken , (O All false positive errors must be reported to NRC Section 2.9 of Appendix A: (a) Minor conforming edits (b)+(c)+(d)+(e)+(0 Clarifying and conforming changes to MRO duties for reporting and review of results (d) Clarification of clinical evidence of abuse (0+(g) Medical determination of fitness to perform duties defined , $ (h) Conforming language for extrapolation of BAC results between 0.02 and 0.04 (i) Minor clarifying edits Section 3.2 of Appendix A:
- Section deleted and incorporated into {26.29(c)
Section 4.1 of Appendix A: (a) SAMHSA replaces NIDA and change of room number List of Subjects in 10 CFR Part 26 Alcohoi abuse, Alcohol testing, Appeals, Chemical testing, Drug abuse, Drug testing, J Employee assistance programs, Fitness for duty, Management actions, Nuclear power reu. tors, Protection of information, Reporting and recordkeeping requirements, Sanctions. IG i
F$r the reasons set out in the preamble and under the authority of the Atomic Energy ,
; Act of 1954, as amended, the Energy' Reorganization Act of 1974, as amended, and ' ;
- 5 U.S.C. 553, the NRC is proposing to adopt the f Ilowing amendments to _10 CFR Part 26.'
- l. ;The authority citation for Part 26 is revised to read as follows: ;
Autbority: Secs. 53, 81,103,104,107,161, 68 Stat. 930, 935, 936, 937, 939, 943,' as {
's amended, (42 U.S.C. 2073, 2111, 2112, 2133, 2134, 2137, 2201): secs. 201, 202, 2%, 88
- Stat.1242,1244,1246, as amended (42 U.S.C. 5841,5842, 5846).
- 2. In { 26.2, paragraphs (a) and (d) are revised, and new paragraphs (e), and (f) are added to read as follows:
L { 26.2 Scope. l (a) The regulations in this part apply to licensees authorized to operate a nuclear power , reactor, to possess or use formula quantities of SSNM, or to transport formula quantities of , SSNM. Each licensee shall implement a fitness-for-duty program which complies with this . -- part. - The provisions of the fitness-for-duty program must apply to:
' (1) All persons granted unescorted access to nuclear power plant protected areas; l
(2) Licensee, vendor, or contractor personnel mquired to physically report to a licensee's Technical Support Center (TSC) or Emergency Operations Facility (EOF) in g accordance with licensee emergency plans and procedures;_ 114
(3) SSNM licensee and transporter personnel who: i i i (i) Are granted unescorted access to Category lA Material; (ii) Create or have access to procedures or records for safeguarding SSNM; (iii) Make measuiements of Category IA '<!aterial; (iv) Transport or escort Category IA Material; or (v) Guard Category IA Material; and (4) FFD program personnel who: (i) Can link test results with the person who was tested; (ii) Make removal and return-to-work recommendations or decisions; (iii) Are involved in the selection and notification of employees for testing and in the collection and on site testing of specimens. 115 l i
. .. _ . _ _ _ . . _ _ _ - . _. . . ~ _ _ . . _ . _ _ _ _ _ _ _ _ . . . _ _ . .
o l(d) The regulations in this part apply to the Corporation required to obtain a certificate ;
~
of compliance or an approved compliance plan under Part 76 of this chapter only if the ' Corporation elects to engage in activities involving formula quantities of strategic special .; i
- nuclear material, When applicable, the requirements apply only to the Corporation and personnel c' arrying out the activities specified in 6 26.2 (a) (3).
(e) For facilities in the process of being d commissioned, the scope of a fitness for- [ . duty program may be reduced to persons and specified areas as deemed appropriate by the . NRC to protect public health and safety. , 4
-(f) Persons performing activities under this part who are covered by a program segulated by another Federal agency or State that meets the general performance objectives of g
this part need only be covered by those aspects of a licensee's fitness.for-duty program not included in the Federal agency or state program.
- 3. Section 26.3 is amended by removing the definitions for follow-up testina, random jg}1, and suitable inauiry, revising gljggg[, confirmatory test, and confirmatory nosit ive test, and adding in alphabetical order the following defmitions, abuse of lenal druon, behavioral observation, blood alcohol concentration, HHS-certified laboratory. laboratory-confirmed
. positive, licensee's teetino facility, medical determination of fitness, substance abuse.
1 subversion an subvert the testinn crocess supervisor, and unconfirmed nositive test result.
- t 26.3 - Definitions.
116
O i Abuse of legal drugs means the use of.a legal drug (e.g., alcohol, prescription, over -
;the-counter drugs) in a manner that constitutes a health or safety hazard to the individual or to others, including on-the job impairment. Legal or employment actions against an ir.dividual for use oflegal drugs constitute evidence of the existence of a health or safety hazard.
Aligget means s' portion'of a specimen used for testing, it is taken as a sample ~ representing the whole specimen. p
- Behavioral observation means observation by supervisors in the course of their contacts with other personr.el to.det:ct degradations in performance, signs ofimpairment, or.
changes in behavior which may indicate the need to evaluate an individual's fitness for duty. 4 Blood Alcohol Concentration (BAC) means a measure of the mass of alcohol in a
-volume of blood.
Confirmatory test means a second analytical procedure to identify the presence of a specific drug or drug metabolite which is independent of the screening test and which uses a different technique ud chemical principle from that of the screening test in order to ensure reliability and accuracy. (At this time, gas chromatography /mos spectrometry (GC/MS) is the only authorized confirmation method for cocine, marijuana, opiates, amphetamines, and phencyclidine.) For determining blood alcohol levels, a " confirmatory test" means a second I test using another breath alcohol analysis device. Additional information may be obtained by l gas chromatography analysis of blood. Confirmed nositive test means a laboratory confirmed positive test result that has been verified as a _ violation of FFD policy by the Medical Revicw Officer (MRO) after evaluation. 117 l i
= _ . - - - :. .
... .v l
. A " confirmed positive test" for alcohol is obtained as a result of a confirmation of bloodl
. alcohol levels of 0.04 percent or higher with a second breath analysis without MRO evaluation or as the result of an extrapolition back in time (back calculation) performed by the MRO.-
i
. . . i HHS-certified laboratory means a urine testing laboratory that maintains certification to perform drug testing under the Depanment of Health and Human Services (HHS) " Mand Guidelines for Federal Workplace Drug Testing Programs." ,
Laboratory confirmed nositig means the result of a confirmatory test that has established the presence of drugs, or drug metabolites, at a sufficient level to be an indication of prohibited drug use. Licensee's testinc facility means a drug testing facility operated by the licensee or one
+
of its vendors or contractors to perform on site the initial testing of urine specimens. Medical determination of fitness means the process whereby a licensed physician, who may be the MRO, qualified to make such determination examines and interviews an individual
- and reviews any appropriate and relevant medical records, in accordance with standard clinical procedures, in order to determine whether there are indications that the individual may be in violation of the licensee's FFD polky or is otherwise unable to safely and competently I18
. .- , .: 1
, ., j y .. .
,i
- perform dutiestThe qualifications for making the determination are related to the fitness
~
- Issues yi. .i.cd by the patient.-
1
?
i 1 Screening test means an immunoassay screen'for drugs or drug metabolites' to i - - eliminate " negative" urine specimens from furthe consideration, or the first breathalyzer test ,, i for alcohol. Initial screening may be performed at the licensee's testing facility; a second , - screen and confirmation testing for drugs or drug metabolites must be conducted by a HHS- 1
-. ;i
- certified laboratory.
substance abuse means the use, sale, or possession of illegal drugs or the abuse of - legal drugs (e.g., alcohol, prescription' drugs, and over the-counter drugs) or other substances. , Subversion and Subvert the testinn crocess mean an act intended to avoid being tested ,
- ' or to bring about an inaccurate drug or alcohol test result for oneself or others. Acts of subversion can occur at any stage of the testing program including selection and notification of individuals for testing, specimen collection, specimen analysis, and testing result reporting processes and can include providing a surrogate urine specimen, diluting a specimen, (in vivo f
i or in vitm) and adding an adulterant to a specimen. Supervisor means any person who has the immediate oversight responsibilities to direct
- -. activities of any other person or person.= within the protected area or has ongoing ,
responsibility for the supervision of an individual with unescorted access status while that -
- individual is not in the protected area.
119 , L. , d g, -
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s
. Unconfirmed nositive test result means the result of a screening test for drugs and drug metabolites that indicates the presence of some drug or drug metabolite and that has the potential to be confirmed through GC/MS testing by an HHS-certified laboratory as a laboratory confirmed positive test result, or the result of a screening test for alcohol indicatir.g a blood alcohol content of 0.02 percent or greate..
6
- 4. Section 26.7 is added to read as follows:
6 26.7 Communications. Except where otherwise specified in this part, all communications and reports concerning the regulations in this part must be addressed to the NRC Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Copies of all communications must be sent to the appropriate regional office and resident inspector. Communications and reports may be delivered in person at the Commission's offices at 2120 L Street, NW., Washington, DC, or at 11555 Rockville Pike, One White Flint North, Rockville, Maryland. i 26.8 [Amendedj 5._ In i 26.8, paragraph (c) is removed. 120
9~
- i. In i 26.20, the introductory text and paragraphs (a), (c), (d), (c), (e)(1), (e)(2), and (f) are revised to read as follows:
{ d i i 26.201 Written policy and procedures.
- Each licensee subject to this part shall establish and implement written policies and procedures designed to meet the general performance objectives and specific requirements of this part. Each licensee shall retain a copy of itt !stest written policy and procedures as a -
record until the Commission terminates the licenses for which the policy and procedures were developed. If any portion of the policies and procedures are cuperseded, the superseded material must be retained for at least three years. As a minimum, written policies and procedures must address fitness for duty through the following:
-(a) An overall description of licensee policy on fitness for duty. The policy must address use of and offsite involvement with i.negal drugs, abuse oflegal drugs (e.g., alcohol, prescription and over-the-counter drugs), subversion of the testing process, and refusals to provide a specimen for testing. A clear and concise wTitten statement of this policy must be prepared and be in-sufficient detail to provide affected individuals with information on what is expected of them, and what consequences may result from lack of adherence to the policy.
This statement must be readily available to au persons subject to the policy.
. (1) As a minimum, the written policy must prohibit the consumption of alcohol--
(i) Within an abstinence period of at least 5 hours preceding any scheduled working-tour, and 121
u , t _(ii) During the period of any working tour. _ r d l (2) Licensee policy should also address other factors that could affect fitness for ' utyi such as mental stress, fatigue, illness, and .the use of prescription and over-the-counter medications that could cause irr.peirmentc
. . . 3 e
(c) Procedures to be utilized in testing for drugs and alcohol, including procedures for protecting individuals providing a specimen and the integrity of the specimen, and the quality L controls used to ensure the test results are valid and attributable to the correct individual. l L
-(d) A description of immediate and follow-on actions which will be taken, and the procedures to be utilized, in those cases where persons who'are employed by licensees, vendors, or contractors, and are assigned to duties within the scope of this part, are -
determined tb have-- (1) Been involved in the use, sale, or possession of illegal drugs; (2) Consumed alcohol during the mandatory pre-work abstinence period, while on duty, or to excess before reporting to duty as demonstrated with a test that can be used to
' determine blood alcohol concentration; L
122 i I _. -_ _
. ( _ , - - _ , - _ . -
3* - .. .
- i
;o
' ; (3) Attempted to subvert the testing process by adulterating or diluting specimens (in -
-l vivo or in vitro), substituting spec _imens, or by any other means; or-(4) Refu:,ed to provide a specimen for analysis, h i
(e) A procedure that will ensure that persons called in to perform an unscheduled working tour are fit to perform the task assignet As a minimum, this procedure must-(1) Require a statement to be made by a called-in person when contacted as to whether - . he or she considers himself or herself fit to perform the task assigned and whether he or she
- has consumed alcohol within the length of time stated in the pre-duty abstinence policy; 4
- (2) If alcohol has been consumed within this period, require a determination of fitness for duty by breath analysis or other means (collection of urine under { 26.24 (a) (3) is not required); and -
i-
. (f) Licensees seeking to grant unescorted access pursuant to 10 CFR 73.56 to
$ personnel covered by another licensce's FFD program that complies with this part may credit that licensee's program through verification that the individual is currently and will continue to be subject to the random testing and behavioral observation programs of either his or her employer or those of the host licensee.
- 123 w * *7t-- ermw*4g-4 g- m -e- c -
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- 7. -
!!n i 26.21, the introductory text of paragraph (a) and paragraphs (a) (2) and (b) are _
revised to read as follows: 1 i 26.21 L Policy commucications and awareness training. . (a) Persons assigned to activities within the scope of this part must be provided with , T appiopriate training to ensure they understand-(2) The personal and public health and safety hazards associated.with the use of illegal drugs and the abuse of legal drugs including alcohol; (b) Initial training in the five topics in paragraph (a) of this section must be completed before assignment to activities within the scope of this part. Refresher training in those five topics must be completed on a nominal 24 month frequency or more frequently where the ' need is indicated. A record of the training must be retained for a period of at least three
-years. Licensees may accept training of individuals who have been subject to another Part 26 -
c program and who have had initial or refresher training within the 24 months before assignment provided that training by the accepting licensees in the site-specific topics covered
~ by paragraphs (a) (1), (4), and (5) of this section is completed before the granting of unescorted access to the protected area. l l
~124 I
- 8. In { 26.22, the introductory text of paragraph (a) and paragraphs (a) (4) and (c)'are i
revised to read as fellows: 9 26.22 Tralaing of supervisors and escorts. (a) Managers and supervisors of activities within the scope of this part must be - provided appropriate training to ensure they understand-(4) Behavioral observation techniques for detecting degradation in performance,- impairment, or changes in an individual's behavior; and ~ (c) Initial training for escorts and licensee employees' supervisors must be completed before assignment of duties within the scope of this part, except that after an initial supervisory assignment, the initial training must be completed as soon as feasible but no later - than 3 momhs following the assignment of supervisory duties. Initial training for supervisors of contractor perr,onnel must be completed before assigmnent of the supervised contractor personnel to duties within the scope of this part or within 10 days after initial supervisory assignment, whichever is later. Refresher training must be completed on a nominal 12 month frequency, or more frequently where the need is indicated. A written examination on the training material given on a nominal 12 month frequency may be used in lieu of refresher - : training. Tbe written examination must require a demonstration of adequate knowledge of the 125
.- e areas covered in paragraph (a) of this section. Refresher training must be completed on a nominal 36-month frequency even if examinations are used to fulfill this requirement during the interim period. ~A record of the training or examination in lieu of training must be retained for a period of at least three years. Licensees may accept training ofindividuals who have been subject to a Part 26 program and who have had initial or refresher training within the 12 months before assignment provided that training by the accepting licensee in the topics covered by paragraphs (a) (!), (2), and (5) of this section is completed before granting unescorted access to the protected area.
- 9. In { 26.23, the introductory text of paragraph (a) and paragraph (a) (2) are revised to read as follows:
l 26.23 Contractors and vendors. (a) All contractor and vendor personnel perir ning activities within the scope of this part for a licensee must be subject to either the licenas p.ogram relating to fitness for duty, or to a program, formally reviewed and approved by the licensee, which meets the requirements of this part. Written agreements between licensees and contractors or vendors for activities within the scope of this part must be retained for the life of the contract and will clearl., show that-- (2) Personnel with a known history of substance abuse or having been denied access or removed from activities within the scope of this part at any nuclear power plant for violations 126
+:.- .. j i
of a fitness for-duty policy will not be assigned to work within the scope of this part without - ,
- I
. the knowledge and consent of the licensee.
a
- 10. In i 26.24, paragraphs (a), (c), (d) (1), the introductory text of (d) (2), (d) (2) (i) and (d) (2) (iv) are revised, paragraphs (c), (f), end (p) are redesignated 'as paragraphs (f), (g), and - :
i (h) and revised, and new paragraphs (e) and (i) are added to read as follows: . . t i 26.24 Chemical testing. (a) To provide a means to deter and detect substance abuse, the licensee shall implement the following chemical testing programs for persons subject to this pan: (1) (i) Preaccess testing for drugs and alcohol must be conducted within 60 days before the initial grcnting of unescorted access to protected areas or assignment to activities within the scope of this pan unless the individual: (A) Has been covered by a program meeting the requirements of this pan for at least
'30 days during the 60 days immediately previous to the granting of unesconed access, and ,
(B) Has no history of substance abuse.
- (ii) Any negative drug and alcohol test meeting the standards of this part and performed within 60 days before granting unesconed access may serve as the preaccess test.
-127 l
..J
1
~
4 A negative test result must be obtained before the granting of unescorted access unless the , individual has no history indicating the use of illegal drugs or the abuse of legal drugs (e.g., alcohol, prescription;and over-the counter drugs) and has either had a negative test result on a test meeting the standards of this part performed within six months before granting unescorted , access or has been covered by a program meeting the standards of this part for two
~
consecutive weeks during that period. (2) Unannounced drug and alcohol tests rrust be imposed in a statistically random and unpredictable manner so that all persons in the population subject to testing have an approximately equal probability of being selected and tested. Randorn *estin'g must include testing during all types of work periods, including weekends, backshifts, and holidays. The tests must be administered so that a person completing a test is immediately eligible for another unannounced test. At a minimum, tests must be administered on a nominal weekly frequency and at various times during the day. Reasonable efforts must be made to test persons selected for randum testing. Persons off site when selected for testing, and not. (_ reasonably available for testing in a timely manner, must be tested upon returning to the site. , For persons off site for more *han sia ty days, such tests will fulfill the requirement for return-i to-duty testing and should be reported to the NRC as random tests. Random testing must be l-o
- conducted at an annual rate equal to at least 50 percent of the workforce.
l (3) (i) For-cause drug and alcohol testing must be conducted L (A) Following any observed behavior or physical condition that creates a reasonable suspicion of possible substance abuse including attempts to subvert the testing prucess; l l 128
- . ..~ -.. . ._
o 1 (B) After accidents involving a failure in individual performance resulting in personal I injury, in a radiation exposure or release of radioactivity in excess of regulatory limits, or actual or potential substantial dcgradations of the level of safety of the plant if there is reasonable suspicion that the individual's performance contributed to the event; and
.(C) after receiving credible information that an individual is abusing drugs or alcohol.
(ii) The individual's unescorted access status must be suspended until pronounced fit , for duty based on a medical determination of fitness. If the test is based on suspected use of alcohol and the breath analysis is negative, the individual, if detennined fit for duty by a medical determination of fitness, may be returned to duty pending results of urinalysis for drugs. For cause drug and alcohol testing must be conducted as soon as practicable, but within no more than 2 hours for an alcohol test and 8 hours for specimen collection for a drug test. (4) Follow up testing must be conducted on an unannounced and unpredictable basis to verify continued abstention from the use of substances as covered under this part. An individual (i) Whose unescorted access is reinstated after a suspensinn under f 26.27 (b) (3), or (ii) is granted unescorted access after removal under { 26.27 (b) (3) or (4) must be
. subject to follow-up testing that is tailored to the individual's medical history but not less l:
129 l
4 frequently than once every month for four months ar.d at least once every three months for the next two years and eight months after unescorted access is reinstated. (5) Return to duty testing must be conducted when a person seeks to regain unescorted access to protected areas of the site in question after an absence from the possibility of being tested under that site licensee's program for more than 60 days or when a person seeks to regain unescorted access after having been denied access under the provisions of 6 26.27 (b). Any negative drug and alcohol test meeting the standards of this part .md perfonced within 60 days before the 5.snting of unescorted access may serve as the return-to. duty <c u .ncept in the case of those who have been uenied access under the provisions of s 16 T/ (b) A l negative test result must be obtained before the granting of uiiescoin d ao.c.,5. inn the 1 l individual has no history indicating the use of illegni i op ,, .he abu- d % .. 1 ngf y 9 alcohol, prescription and over-the-counter drug.)< and cohei has leJ a .m.,9 w a-o:t 40 a test meeting the standards of this part performed uithin si> inoo:he hefM it': 6 m vnt of unescorted access or has been covered by a prograin meeting the wumianh . f dos n m ior two consecutive weeks during that period. l (c) Licensees shall test specimens collected under each type of test listed in g 26.21 (a) for all substances described in paragraph 2.1 (a) of the NRC Guidelines ( Appendix A to Pr.rt 26). In addition, licensees may consult with local law enforcement authorities, hospitals, and drug counseling services to determine whether other substances with abuse potential are being used in the geographical locale of the facility and the local workforce. When appropriate. 130
m . _ . . ._ m ._- . . . . _ . _ . __ . . _ . _ _ _ _ __ -._ _ _
- l C ? _. g i _! C - ,
> = other subitan,:es so identified may be added to the panel of substances for testing. ; iAppropriate cut-off limits must be established by the license for these substances, - l t (d)(1). All collected urine and blood specimens must be forwarded to a laboratory-- l cenified by the Depanment of Health and Human Servi 6es (HHS), except that licensees may ;
. conduct tests of aliquots to determine which specimens are negative and need no further testing, provided the licensee's staff possesses the necessary training and skills for the tasks assigned, the staffs qualifications are documented, and adequate quality controls for the .
testing are implemented. All such testing of specimens must include tests to ensure specimen validity as required by Section 2.7 (e) of Appendix A to Part 26. Quality control procedures for screening tests by a licensee's testing facility must include the processic.g of blind - h performance test specimens and the submission to the HHS certified laboratory of a sampling of specimens initially anlyzed as negative. Except for the purposes discussed in { 26.24 (d)
- (2), acce.as to tl: results of the above screening tests must be limited to the licensee's testing staff, the Medical Review Officer (MRO), the Fitness-for Duty Program Manager, and ;
employee assistance program staff, when appropriate. 4-(2) An individual may not be removed or temporarily _ suspended from unescorted
- access or be subjected to other administrative action based solely on an unconfirmed positive result from any drug test, other than for marijuana (THC) or cocaine, unless other evidence 4
indicates that the' individual is impaired or might otherwise pose a safety hazard. With respect to on site screening tests for marijuana (THC) sad cocaine, licensee management may-
- be informed and licensees may temporarily suspend individuals from unescorted access or d
, 131-h
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J from normal' duties or take lesser administrative actions against the individual based on an: unconfirmed _ positive test result provided the licensee complies with the following conditions:
'(i) For the drug for which action will be taken, at least 85 percent of the unconfirmed positive iest results from on-site screening tests during the last 12 month data reporting period ,
submined to the Commission under i 26.71 (d) were subsequently reported as positive by the 1 i
'HHS-certified laboratory as the result of a GC/Mf' confirmatory test.-
i Oy) No disclosure of the temporary removal or suspension of, or other administrative wnu mainst, an individual whose test is not subsequently confinned us a violation of FFD o4 , .uy be mnde in reynnse te a sunable ing'iiry conducted under the provisions of
; 161. i),8 backgronud investigation undocted unda the provisions of 6 73.$6, or to any Ae, .oquiry or investigation. For the purpose of assuring that no records have been retained, .
n ecess to she viem of tiles and records must be provided to licensee personnel conducting
.tpem o ciews, inquiries into an allegation, or audits under the provisions of G 26.80, or to an NRi' imptior or other Federal otlicials - The tested individual must be provided a statement that the recor,is specified in paragraph (d)(2)(iii) of this section have not been retained and
- must be informed in writing that the temporary removal or suspension or other administrative action that was taken will not be disclosed and need not be disclosed by the individual in response to requests for information concerning removals, suspensions, administrative actions
' or history of substance abuse.
132
(e) The period of time albwed between_the notification of the individual and the actual collection of a specimen must be kept at a minimum consistent with operational constraints. Whenever practicable, the individual Aould not be allowed the time or opportunity to obtain materials or take any action that would subvert the testing process or the
. test results.
(f) The Medical Review Officer shall complete the review of test results repotted by the HHS-certified laboratory and notify licensee management as soon as practicable. The MRO shall report all determinations of violations of the licensee's FFD policy (e.g., positive test results and attempts to avoid detection) to management in writing and in a manner designed to ensure confidentiality of the information. To assure that action is taken immediateiy, provisions must be made to ensure that the MRO is able to contact appropriate licensee management at any time. Should the MRO's review not be completed within 14 days of the collection of a specimen, licensee management must be advised of available test results, the status of the review, the reasons for the fielay, and appropriate recommendations. (g) All testing of urine specimens for drugs, except screening tests performed by licensees under paragraph (d) of this section, must be performed in a laboratory certified by the U.S. Department of Health r.nd Human Services (HHS) for that purpose consistent with its standards and procedures for certification. Except for suspect specimens submitted for special processing (Section 2.7 (d) of Appendix A to Part 26), all specimens sent to HHS-certified laboratories must be subject to screening analysis by the laboratory and all specimens screened as unconfirmed positives must be subject to confirmatory testing by gas chromatography / mass spectroscopy analysis by the laboratory. Licensees shall submit blind performance test 133
7 a . l specimens to HHS-certiflid laboratories in' accordance with the NRC Guidelines. I.icensees 1 must ensure that all collected _ specimens are tested at d that IW,ratories report results for all specimens sent for testing, including blind performance test specimens. p (h) Tests for alcohol must be~ administered by breath analysis using breath alcohol , analyses devices meeting evidential standards described in Section 2.7 (p) (3) of Appendix A to Part 26. If the screening test shows a bresth alcohol content indicating a BAC of 0.02 4
. percent or greater, a confirmatory test for alcohol must be performed using another breath measurement' instrument. A confirmatory test result showing a breath alcohol content indicating a BAC between 0.02 percent and 0.04 percent must be forwarded to the MRO for
" evaluation as described in Section 2.9 (h) of Appendix A to Part 26. A confirmatory test for alcohol indicating a blood alcohol concentration (BAC) of 0.04 percent or greater must be declared a positive test. Further testing for alcohol must be administered if demanded by the , L !- mdividual for the purpc,ses of obtaining additional information that could be considered during an appeal pursuant to { 26.28. Any such test must be a gas chromatography analysis of blood performed on a blood specimen drawn, with the consesa of the individual, promptly after the confirmatory breath analysis. Any detectable quantity of alcohol in the blood specimen may be considered, including extrapolation back in time, to determine if a violation of the FFD I policy occursed. l (i) If an individual has a medical condition that makes collection of breath, blood, or l. urine specimens difficult or hazardous, the MRO, in consultation with the treating or personal ph'ysician, may authorize an attemative evaluation process, tailored to the individual case, for-l determining whether a violation of fitness-for-duty policy has occurred, provided this process 134
*
- i 1
includes measures to prevent subversion and can achieve results comparable to those produced by urinalysis for illegal drugs and breath analysis for alcohol.-
- 11. Sectin 26.25 is revised to read as follows:
i 26.25 Employee assistance programs (EAP). Each licensee subject to this part shall maintain an employee assistance program to strengthen fitness-for-duty programs by offering assessment, s*. ort-term counseling, referral . services, and treatment monitoring to employees with problems that could adversely affect the performance of activities within the scope of this part. Employee assistance programs must be designed to achieve early intervention. The EAP must also provide Eir confidential assistance except that the employee assistance program staff shall inform licensee management when a determination has been made that any individual's condition constitutes a hazard to himself or herself or others (including those who have self referred).
- 12. Section 26.27 is revised to read as follows:
{ 26.27 Management actions and sanctions to be imposed. (a) (1) (i) Before the initial granting of activities within the scope of this part, as described in { 26.2 (a), the licensee shall obtain a written statement from the individual as to
- whether he or she:
(A) Has in the past 5 years used, sold, or possessed any illegal drugs. or had a legal or employment action taken against him or her for alcohol or drug use; 135 (-
- - -- -- . - - . _ - - ~ - - - . . -.
~ (B) Has in the past 5 years been determined to have violated a fitness for-duty policy,-
or as a result of action taken'in accordance with an FFD policy been denied initial assignment , to activities within the scope of this part as described in f 26.2 (a), or has been subject to a plan for treating substance abuse (except for self referral for treatment); or s (C) Has at any time as a result of action taken in accordance with an FFD policy been removed from activities within the scope of this aut as described in i 26.2 (a). (ii) Power reactor licensees need not obtain statements responding to the activities listed in { 26.2 (a) (3) unless the background investigation conducted in accordance with 10 CFR 73.56 indicates the person was previously employed by a licensee authorized to possess or transport Category i nuclear material. . (2) The statement must include the individual's declaration as to the specific type, l duration, and resolution of any such matter. (3) The licensee shall complete a suitable inquiry on a best efforts basis to verify the accuracy of the individual's written statement under (a) (1) and (a) (2). This suitable inquiry should cover at least the past 5 years but in no case less than the past 3 years. (4) If a record of the type described in paragraphs (a) (1), (2), and (3) of this section i is established which raises a concern about the person's history of alcohol or drug use, the - l new assignment to activities within the scope of this part or granting of unesconed access
\
l must be based upon a management and medical determination of fitness for duty and the l L 136 u -
.y .
establishment'of an appropriate follow up testing program, as specified in { 26.24 (a) (4).; The restrictions of paragraph (b) of this section must be observed.' To meet the suitable
-inquiry requirement, the idemity of persons denied unescorted access or removed under the provisions of this pan and the circumstances for the deriial or removal, including test results, will be made available in response to a licentse's, contractor's, Lor vendor's inquiry supported
. by a release signed by the individual being investigated that authorias the disclosure of the
-l inf3rmation. - A suitable inquiry nc:d not be conducted for any period of 30 days or less that the individual was not covered by an FFD program meeting the requirements of this part.
(5) Failure by an individual to list reasons for removal or revocation of unescorted i I
- access or failure to authorize the release of information is sufficient cause for denial of unescorted access. Temporary unesconed access pursuant to 10 CFR 73.56 may not be e.ffected by this pan provided that the applicant for unesconed access passes a chemical test conducted according to the requirements of ( 26.24 (a) (1).
4 h (b) Each licensee subject to this part shall, at a minimum, take the following actions. The requirements of this paragraph do not prohibit the licensee from taking more stringent action. F (1) Personnel, including applicants, who are impaired, those whose fitness may be questionable, and those determined to have violated the licensee's fitne+/or-duty policy shall be immediately denied unesconed access or otherwise removed from activities within the scope of this pan. These persons may be assigned to or returned to their duties only after impairing or questionable conditions are resolved and the individual is determined to be fit to
- 137
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l . safely and competently perform activities within the scope of this part by an appropriate manager and a licensed physician qualified to make the medical determination of fitness. (2) Lackir.g any other evidence to indicate the use, sale, or possession of illegal drugs or une of alcohol on site, the following must be presumed to be an indication of off site dreg or alcohol use in violation of the company FFD policy: (i) A laboratory confirmed positive test result that is verified by the MRO as a policy
- violation; and (ii) A cenfirmatory breath test for alcohol that indicates the individual had a BAC of 0.04 percent or greater during any scheduled working tour.
(3) The first violation of the FFD policy involving a confirmed positive drug or alcohe zetermination must, at a minimum, result in immediate removal from activities within thizope of this part for at least 14 days and referral to the EAP for assessment and coumeling during any suspension period. Plans for treatment, follow up, and future employmen', if applicable, mur be developed, and any rehabilitation program deemed appropriate must be initiated during suG suspension period. Although the individual must be removed f. om activities covered by this part, the individual must continue to be covered during any suspension period by the license (4 FFD program with respect to behavioral observation if in a work stetus, chemical testing, and sanctions for violations of the licensee's
- FFD policy, ' Before an individual is permitted to be retumed to duty or assigned to perform activities within the scope of this part, the individual must be determined to be fit to safely
~138
l and competently perform such activities by an appropriate manager and a licensed physician qualified to make the medical determination of fitness. A return to duty test under 6 26.24 (a) (5) must be conducted before the individual may be returned to duty and follow.up testing y under i 26.24 (a) (4) must be conducted to verify continued abstinence from the ase of l subt.tances. Any subsequent violation of FFD policy, including during an assessment or
~
treatment period, must immediately result in removal from activities described in { 26.2 (a) for a minimum of 3 years from the date of removsl. i (4) Any individual determined to have been involved in the sale, use, or possession of illegal drugs or the use of alcohol while, as applicabic, within a prot:cied area of any nuclear power plar.t, wi'hin a facility that is licensed to possess or use SSNM, or within a l trangotter's facility or vehicle, must immediately be removed from activities within the scope - ; of this part as described in { 26.2 (a) for i minimum of 5 years from the date of removal. l (5) Persons removed for periods of three years or more under the provisions of Paragraphs (b)(2), (bX3), (b)(4), and (c) of this section and who would have been removed under the current standards of a hiring licensee, may be granted unescorted access and j assigned duties within the scope of this cart by a licensee subject to this part only when the ) hiring licensee receives satisfactory medical as,urance that the person 1,as abstained from the use of illegal drugs or the abuse of legal drugs (e.g., alechol, prescription and over the. : l counter drugs) for at least three years. Before an individual is permitted to be retumed or assigned to perform activities within the scope of this part, the individual must be determined' to be fit to safely and competently perform these activit esi by an appropriate manager and a licensed physician qualified to make the medical determination of fitness; A retum.to-duty 139 l 1 7c o
test under { 26.24 (a)(5) must be conducted before the individual may be assigned duties and follow up testing under 6 26.24 (a) (4) must be conducted to verify continued abstinence from the use of substances. Any further violation of FFD policy must immediately result in permanent denial from activities described in { 26.2 (a). (6) Paragraphs (b) (2), (3), (4), and (5) of this section do not apply to valid prescriptions or over the counter drugs. Licenser r.anctions for confirmed abuse of valid prescription and over the counter drugs must be sufficient to deter abuse of legally obtainabll substances as a substitute for abuse of proscribed drugs. l l (c) Any act or attempted act to subvert the testing process must be a violation of the licensee's FFD policy and must result in denial of unescorted access for a minimum of 3 years. A refusal to provide a specimen, effort to subvert the testing process, or resignation before removal for violation of company fitness for duty policy concerning drugs and alcohol must be recorded and provided in response to a suitable inquiry. The specific cause for a removal, e.g., that a laboratory confirmed positive test result was obtained and that the individual resigned before an MRO review, must also be provided in response to a suitable inquiry. A record of these actions must be retained for five years following denial of any access authorization for the purpose of meeting the requirements of ( 26.27 (a). (d) If a licensee has a reasonable belief that an NRC employee or NRC contractor may be under the influence of any substance, or otherwise unfit for duty, the licensee may not deny access but shall escort the individual. In any instance of this occurrence, the appropriate 140
t Regional Administrator must be notified immediately by telephone. During other than normal working hours, the NRC Operations Center must be notified. t
- 13. Section 26.28 is revised to read as follows:
I 26.28 Appeals. Each licensee subject to this part, and each contractor or vendor implementing a fitness for duty program under the provisions of f 26.23, shall esto - h a procedure for r licensee and contractor or vendor employees and applicants for unescorted access to appeal a determination of a violation of FFD policy. The procedure must provide notice to the individual of the grounds for the determination of a violation of FFD policy, and must provide an opportunity to respond and to submit additional relevant information. The procedure must provide for an objective, impartial review of the facts relating to the determination of 3 violation of FFD policy. The review must be conducted by persons not associated with the administration of the FFD program, as described in f 26.2 (a) (4), and may include internal management, if the appeal is successful, the relevant records must be corrected. A licensee review procedure need not be provided to employees of contractors or vendors wher he contractor or vendor is administering its own alcohol and drug testing. , i
- 14. In f 26.29, paragraph (b) is revised and paragraph (c) is added to read as follows:
I 26.29 Protection of information. 141 w
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e (b) Licent.ees, contractors, and vendors may not disclose the personal information collected and maintained to persons other than assigned Medical Review Officers, other , licensees, contractors or vendors, or their authorized representatives legitimately seeking the information as required by this part for unescorted access decisions and who have obtained a release from current or prospective employen or contractor personnel, NRC representatives, appropriate law enforcement ofDelats under court order, the subject individual or his or her - representative, or to those licensee representatives who have a need to have access to the information in performing assigned duties, including medical determinations of 6tness and I audits of licensee, contractor, and vendor programs. to the presiding ofDeer in a judicial or administrative proceeding initiated by the subject individual, to persons deciding matters on review or appeal, and to o.;.er persons pursuant to court order. This section does not authorize the licensee, contractor, or vendor to withhold evidence of criminal conduct from law enforcement ofDelais. (c) Upon receipt of a written request by the subject individual, the licensee, contractor, or vendor possessing such records shall promptly provide copies of all records pertaining to the determination of a violation of the l' ensee's FFD policy, including test results, MRO reviews, and management determinations of results pertaining to the subject individual, ihcords relating to the results of any relevant laboratory certi6 cation review or revocation of l certincation proceeding shall be obtained from the relevant laboratory and provided to the subject individual upon request. l l 142 l
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- 15. In i 26.70, paragraph (b) (2) is revised to read as follows.
i l 1.
)
, 6 26.70 - Inspwtions. t i (b) ] i (2) Duly ' authorized representatives of the Commission may inspect, copy, or take - away copies of any licensee, contractor, or vendor documents, recordt, and reports related to implementation of the licensee, coimuttc;, y vendor fitness for4uty program under the scope ! of the contracted activities. This includes exarnents, records, and reports of FFD service , contractors (e.g., contracted HilS laboratory, Mko, EAP, e.d specimen collection services) related to licensee, contractor, or vendor FFD programs. j t r
- 16. In { 26.71, paragraphs (b), (c) and (d) are revised to read as follows:
. f i 26.71 Recordkeeping requirements.
?
(b) Retain relevant records pertaining to the determination of a violation of the FFD j i policy and the related perso met actions for a period of at least five years; i 143
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4 (c) Retain records of persons made ineligible for three years or longer for assignment to activities within the scope of this pan under the provisions of f 26.27 (b) (3), (4), and (5) l l l or (c), until the Commission term!nsies each license under which the records were created; 1 and I (d) Collect and compile fitness.for-duty program performance data on a standard form and submit these data covering the calendar year . teary 1st through December 31st to the Commission by March ist of the following year. The data for each site (corporate and other. . suppon staff locations may be separately consolidated) must include: random testing rate; ,
-3 drugs tested for and cut offlevels, including results of tests using lower cut offlevels and ;
tests for other drugs; workforce populations tested; numbers of tests and results by population. )
- i and type of test (i.e., pre access, random, for.cause, etc.); substances identified; summary of 1 management actions; number of subversion attempts by type; and a list of events reponed, l The data must be analyred and appropriate actions taken to correct program weaknesses, The data and analysis must be retained for three years. Any licensee choosing to temporarily suspend individuals under the provisions of f 26.24 (d) shall repon test results by process stage (i.e., on site screening, laboratory screening, confirmatory tests, and MRO ;
determinations) and the number of temporary suspensions or other administrative actions taken against individuals based on on site unconfirmed screening positives for marijuana (THC) and for cocaine, c t
- 17. In { 26.73, paragraph (a) is revised to read as follows: ,
i
- l 26.73 Reporting requirements.
i 144- :
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- I (a) Each lice me subject to this pan shall inform the Commission of significant i i
fitnesi for-dutj events including, but not limited to: l t i I (1) Sale, distribution, use, possession, or presence of illegal drugs or use of alcohol i within the protected area, j (2) Any acts by any person licensd under 'O CFR Part 55 to operate a power reactor, i by any supervisory personnel assigned to perform duties within the scope of this part, or by - any FFD program persornwl as specified in i 26.2 (a) (4)-- . l t
-(i) Involving the sale, use, or possession of a controlled substance, (ii) Resulting in determinations that such an individual has violated the licensee's FFD.
policy, ; (iii) Involving use of alcohol within the protected area, or , (iv) Resulting in a determination of unfitness for scheduled work due to the consumption of alcohol, (3) Any act that would cast doubt on the honesty and integrity of the FFD program t personnel specified in i 26.2 (4) (4), 4 I 145
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.- ,l l
1 (4) Arrest of a worker for sale, distribution. use, or possession of illegal drugs on or ; oft site. 5 i
- 18. In i 26.80, paragraphs (a) and (c) are revised to read as follows: ,
- l
$ 26.80 ' Aud6ts. t (a) Each licensee subject to this part shall audit the fitness for-duty program as needed but no less frequently than every 36 months. Licensees are responsible for determining the appropriate frequency, scope, and depth of auditing activities within the three year period based on review of program performance indicators such as the frequency, rature, and severity of discovered problems, testing errors, personnel or procedural changes, previous audit findings, and " lessons leamed." As soon as reasonably practicable, but not later than 12 months after a significant change in fitness for-duty personnel, procedures, or equipment, licensees shall audit the particular program element (s) affected by that change to assure continued program effectivenen. Program elements which must continue to be audited nominally every 12 months include FFD program elements implemented by contractors and P vendors under the provisions of f 26.23, testing grformed 'at HHS certified laboratories, and .
FFD services provided to the licensee by contractors and vendors off site or not under the direct daily supervision or observation of licensee personnel. Licensees may accept audits of . contractors and vendors conducted by other licensees and need not re audit the same
. contractor or vendor for the same period of time. Each sharing utility shall maintain a copy 3 of the audit report, to include findings, recommendations, and corrective actions. Licensees 146'
0 i retain responsibility for the effectiveness of contractor and vendor programs and the l
-f implementation of appropriate corrective action.
(c) The result of the audit, along with recommendations, if any, must be documented and reported to senior corporate and site management. The resolution of the audit findings and conective actions must be documented. The documents must be retained for three yearst Appendix A To Part 26 Guidelines For Drug and Alcohol Testing Programs
- 19. Section 1.1 of Appendix A to Part 26 is revised to read as follows:
1.1 Applicability (a) These guidelines apply to licensees authorized to operate nuclear power reactors and licensees who are authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM). (b) Licensees may. set more stringent cut off levels than speciSed herein or test for substances other than'specified herein and shall inform the Commission of such deviation within 60 days ofimplementing such change. Licenwes may not desinte from the other provisions of these guidelines without the written approval of the Commission. s 147-i:
,- .. l (c) Only laboratories which are HHS certified are authorized to perform urine drug l testing for NRC licensees, vendors, and licensee contractors. ;
i
- 20. Section 1.2 of Appendix A to Part 26 is amended by removing all definitions except chain of custody, collection site,' and collection site ocraQn, adding the def*mition oflimit of b
detection, and revising the introductory statement to read as follows: 1.2 - Denaltions. In addition to the definitions contained in i 2a.3, the following definitions apply: Limit of Detection (LOD) means the lowest concentration of an analyte that an , analytical procedure can reliably detect, which should be signifSantly lower than the , established cut offlevels. 148 l-l
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_ _ ._ . ~ ._ _ __ _ __ _ . _ _ . _ _ . _ _ . _ - _.. . . _ i
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- 21. In Section 2.1 of Appendix A to Part 26, paragmphs (a), (b), and (e) are revised to '
read as follows:- ! i 2.1 The Substances, ! i j (a) Licensees shall, as a minimum, test for marijuana, cocaine, opiates, amphetamines, . l phencyclidine, and alcohol for pre-access, for cause, random, follow-up, and retum to duty tests. -! _( b) Licensees may test for any illegal drugs and may consider any detected drugs or metabolites when detemiining appropriate action during a for cause test or analysis of any- { specimen suspected of being adulterated or diluted (in vivo or in vitro), substituted, or tampered with by any other means. l p , t e e e o e - (e) This section does not prohibit procedures reasonably ir,cident to analysis of a specimen for controlled subs:ances (e.g., determination of pH or tests for specific gravity.. creatinine concentration, or presence of adulterams). 1
' 22. . In Section 2.2 of Appendix A to Part 26, paragraphs (a), the introductory text to paragraph '(d), (d) (2) and (d) (4) are revised so read as follows: _
e i 149 1
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l 2.2 General Adelaistration o.f Testing. . (a) Use of a chain of custody form. The original must accompany the specimen to the HHS-certified laboratory. A copy must accompany any split i,pecimen. The form must be a record on which is retained identity data (or codes) on the individual providing the specimen l and information on the specimen collection process and transfers of custody of the specimen. Chain-of custody forms related to determinations of violations of the FFD policy must be i retsined for a period of at least five years following tenninstion of the individal's unescorted , access authorization as required by 6 26.71 (b), or the completion of all legal proceedings related to a positive test, whichever is later. Chain-of-custody forms recording specimens with negative test results and no FFD violations or anomalies may be destroyed after l appropriate summary information has been recorded for program administration purposes. l l t e e o e e (d) Written procedures, instructions, and training must be provided as follows: e e e e e , (2) A non medical collection site person shall receive staining in compliance with this appendix and shf iemonstrate proficiency in the application of this appendix before serving l l: - as a collection s8 person. ~ A medical professional, technologist, or technician licensed or ; i otherwise approved to practice in the jurisdiction in which collection occurs may serve as a l: collection site person if that person is provided the instructions described in Section 2.2 (d) ; _ (3) of this appendix and perfonns collections in accordance with those instructions. 150-
(4) The option to pro.ide a blood specimen for the purposes of obtaining additional information that could be considered during an appeal pursuant to f 26.28 following a positive confirmatory breath test must be specified in the written instructions provided to individuals tested. Section 2.3 of Appendix A to Part 26 is revised to read as follows: 23. 2.3_ Preventing Subversion of Testing. Licensees shall carefully select and monitor persons responsible for administering the testing program (e.g., collection site persons, on site testing facility technicians, medical review officers, and those selecting and notifying personnel to be tested), based upon the highest standards for honesty and integrity, and shall implement measures to ensure that these standards are maintained. At a minimum, these measures must ensure that the integrity of such persons is not compromised or subject to efforts to compromise due to personal relationships with any individuals subject to testing.' At a minimum: (1) Supervisors, co workers, and relatives of the individual being tested shall not perform any collection, assessment, or evaluation procedures. 151
= - . .
(2) Appropriate background checks and psychological evaluations of the FFD progra personel specified in i 26.2 (a) must be completed before assignment of tasks dire associated with the licensee's administration of the program, and must be conducted at least once every live years. (3) Persons, specified in i 26.2 (a), responsible for administering the testing program shall be subjected to a behavioral observation pr gram designed to assure that they continue to meet the highest standards for honesty and integrity. (4) FFD program personnel, speelfied in i 26.2 (a), responsible for the administration of testing must be subject to drug and alcohol testing as specified in i 26.24 (a). Fitness for-duty program persormel shall be tested by personnel independent of the administration of the FFD program to the extent practicable.
- 24. In Section 2.4 of Appendix A to Part 26, paragraphs (d),(f), the introductory text of paragraph (g), and (g)(4) and (5), (9) throiigh (1 !), (13) through (15), (18) thrnugh (20), (23) through (25), and (27), (h), (i) and (i) are revised to read as follows:
152
. j
.- i 2.4 Specimes Ceuwties Procedersa.
-i
. e l d i
'(d)
- Chain-of Custody." Licensee cWn of custody forms must be proper y execute i by authorised collection site personnel upon receipt of specimens. Handling and i
j transportation of urine and blood specimens from one authorized individual or place to
-t another must always be accomplished through chain of custody procedures. The signature of.
the person (courier) picking up the specimen being shipped to the HHS certified laboratory
) ,
does not haw . Se included on the chain of custody form as long as specimens are sealed in - tamper evident containers and there is a tracking system that identifies the courier company . conveying the specimens to the laboratory, includes a shipment billing or control number, and j requires the signature of the courier. Every effort must be made to minimize the number of persons handling the specimens. 7 .I e . e e e (f) " Privacy." Procedures for collecting urine specimens must allow individual privacy
'i unless there is reason to believe that a particular individual may alter or substitute the specimen to be provided. For purposes of this appendix the following circumstances are the exclusive grounds constituting a reason to believe that the individual may alter or substitute a
- urir. specimen:. ,
i 5 4 4
. 153 >
I sr
,. m- w,m.. . . , , , ..w..e.wme., y. .e w & , , , , - . . . _,.,,,_.,.mm._ .c _e_-...-...-._,,,,,,,,, - - , . , -..,_rw.m.997.,-,-.,.~.,.r-- *m++-*-*--w--r
I [ (1) The individual has presented, at this or any previous collection, a urine specimen that fails to meet the standards for an acceptable specimen as provided in paragraph 2.4 (g) l
)
(15) of this appendix, or the specimen is determined to be of questionable validity under the i provisions of paragraph 2.7 (e) of this appendix. l (2) The individual has presented a urine specimen that falls outside the normal , temperature range, and the individual declines to provide a measurement of oral body temperature by sterile thermometer, as provided in paragraph 2.4 (t,, (15) of this appendix, or the oral temperature does not equal or exc. ed that of the specimen. I (3) The last urine specimen provided by the individual (i.e., on a previous cecasion) was determined to have a specific gravity of less than 1.003 or a creatinine concentration below .2 g/l, (4) The collection site person observes conduct clearly and unequivocally indicating an ; attempt to substitute or adulterate the specimen. (5) The individual has previously been detcrmined to have used a substance inappropriately or without medical authorizat:0n and the particular test is being conducted as a part of a rehabilitation program or on return to service . ter evaluation and/or treatment for a confirmed positive test result. (g) " Integrity and Identity of Specimens " Licensees shall take precautions to ensure that a urine specimen is not adulterated, diluted, or tampered with during the collection 154
. . _ - - - - - _ = . = ,. . - - _ - . . - - _ . - . -
procedure, that a surrogate specimen is not provided. that a blood specimen or breath exhalent tube cannot be substituted or tampered with, and that the information on the specimen container and in the chain-of custody form can identify the individual from whom the specimen was collected. The following minimum precautions must be taken to ensure that authentic specimens are obtained and correctly identified: (4) After the individual has been positively identified, the collection site person shall ask the individual to sign a consent to testing form. The individu:1 shall not be required to list prescription medications or over the counter preparations that he or she car. remember using. (5) The collection site person shall ask the individuel to temove any unnecessary outer garments such as a coat or jacket that might conceal items or substances that could be used to tamper with or adulterate the individual's urine specimen. The collection site person shall ensure that all personal belongings such as a purse or briefcase remain with the outer garments outside of the room in which the ur.ne specimen is collected. The individual may retair, his or her wallet. (9) The collection site person shall note any unusual behavior or appearance on the cha'm-of custody form. 155
(10) In the exceptional event that a designated collection site is inaccessible and there is an immediate requirement for urine specimen collection (e.g., an accident investigation), a public or on site rest room may be used accordir.g to the following procedures. A collectil l site person of the same gender as the individual shall accompany the individual into the restl room which shall be made seeme during the collection procedure. If practicable, a toilet l bluing agent muu be p1wed ein la. Imvl and any accessible toilet tank. The collection site perr.on shall remain in the icst iuom, but outside the stall, until the specimen is collected, if no bluing agent **. m italb H tete. Specimen dihition, the < nllection site person < hall instruct the individual oir t" on .'. n. 1 A n.itil .he ..pecimen u. deliven :o the collection site per$On \flet .he en ei w . lt
, 9. o i he piraes sihn nt'I TI 4pecimen, the individtlal Will he instructed to thi.h la .a. o.a o. r ou iene with II.. i n' lei.fion site pcison in wmpleting the chain ol e i.tv.ly po . :n.c P ' .o d.e pu~>" of th wm v nder is .u moluble. s the lic",- . y . n ,,, +..o.,ipai> thei+bvnho:i I his p"mn whiti
.. .n n 1 .
be lu mh . ..
'. ....I: o , , . . .o de (ll) l'pon n n e " u, enn ;pei noen 60m the indn edual, the ectlection site persco shall sletri.na ib .' :i r .... . o inant:0 . f unne ,nlli moi in meet ..pceitic 1;cer sec testing prognon eq.n. c. .. . . ; . .h. .go ..:ny coll eciett unta ..< lu.k; il leas F) milUliters fin the primary >peciomo. nM m ie. <r.m tity % any onait- e csting and testing for any i
additional drup. Where sollected specimens are >plit under the prmisions of Section 2.7 (k) I of this appendi. x , an aMtional b twililiters must be collected. The totri to be collected 1 should be of sufficient quantity for all analyses and reanalyses and must be predetermined by each licensee, if there is less than the required quantity of urine ia the container, additional urine must be collected to reach the required quantity. Each successive void must be 156
l collected in a separate comainer. (The temperature of any partial specimen in its separate 4 container must be measured in accordance with paragraph (g) (13) of this section, and the , i j partial specimens must be inspected and sealed as described below for a full specimen. Upon i I obtaining the required amount, the partial specimens must be combined in one container.) The individual tray be given a reasonable amount of liquid to drink for this purpose (e.g., ] normally, an 8 oz. glass of water every 30 minutes, but not to exceed a maximum of 24 oz.). j If the individual falls for any reason ;o provide n sufficient quantity of urine, the collection I site person shall contact the appropriate authority to obtain guidance on the action to be taken. d 3 (13) Immediately after the unne specur.en is collected, the collection site person shall l-measure the temperature of the specimen. The temperature measuring device used must accurately reflect the temperature of the specimen and not contaminate the specimen. The licensee shall determine the temperature range within which the specimen temperature must fall based on the type of temperature measuring devices used, and shall clearly specify the temperature range in its collection procedures. The temperature range of an acceptable urine specimen must be designated by the licensee and must be within a band of 3'C/6'F or less, 1 with a lower limit not low tr than 34'C/94'F. The time from urination to temperature measurement is critical and must in no case exceed 4 minutes. : (14) Immediately after a urine specimen is collected, the collection site person shall also inspect the specimen to determine its color and clarity and look for any signs of i 157
- - - - a-- e.+- -
2+ .w-', y3ar e.r12..+- -me ,n,-e,.e4
contaminants or adulteration. Any unusual findings must be noted on the chain of custody form. (15) An acceptable specimen is free of any contaminants, meets the required quantity l of at least 30 ml. and within the acceptable temperature range and not less than 34C/94'F. (i) An individual may volunteer to have his or her oral temperature taken to provide j evidence to counter the reason to beHeve the individual may have altered or substituted tl,e . specimen caused by the specimen's temperature falling outside the prescribed range, t (ii) If there is a reason to beliese that the individual may have altered or substituted Om epaimen because one or more ofIlo acceptance ciiteria is riot met or there is other ,
,,, min v. :.r'ic.e that th,* individad is Stanpling fe subscrt the testing process, another
- ou br. cc.'!celen inunedvilely under direct observation of a same gender collection ;
.:p.. i...
. ile ;. ma if a collection site per>on of the cune gnder is not available, the licensee shall
,eicu a nme gender 6teserver. The >amt measurements must be performed on the second specioico, ated both specimens inust be fhrwarded to the laboratory for testing, t
e e . e e (18) Alcohol breath tests must be performed by using evidential grade equipment as specified in Section 2.7 (o) (3) of this appendix. The equipment must be operated in accordance with the manufacturer's instructions by individuals trained and proficient in the use of the equipment. The screening test consists of analyzing two breath specimens on the 158
~.
.J-._ ~.__.__..____..__1.
same piece of equipment. If there is reason to believe a source of alcohol in the mouth exists (e.g., breath freshener or stomach contents) and the testing device does not have built in protection for the condition, the collection of the first screening breath specimen must be delayed 15 minutes to allow for dissipation of the material. If the analysis of the first breath specimen is essentially zero (less than 0.01 percent BAC), the test is considered negative and no further testing is required. For each individual whose first screening breath specimen is at or above 0.01 percent BAC, a second breath specimen is to be collected and compared after two minutes but no later than 10 minutes after the first specimen is collected. if the two - specimens are within plus or minus 10 percent of the average of the two measurements, then the test result is considered accurate, if the tests of the two specimens are not accurate, the series of two breath tests must be repeated on another evidential grade breath analysis device ensuring that the plus or minus 10 percent accuracy is achieved. If the result of this screening test is greater or equal to 0.02 percent BAC, a confirmatory test is to be accomplished. The confirmatory test is a repeat of the screening test procedure done on another evidential grade breath analysis device. (19) If the alcohol breath tests indicate that the individual is positive for a BAC at or above the 0.04 percent cut off level or that the individual may have been positive for a BAC at or ;.bove the 0.04 percent cut off levtl du;ing any scheduled working tour (i.e., has a confirmatory test result between 0.02 percent BAC and 0.04 percent BAC), the individual may request a blood test, at his or her discretion, for the purposes of obtaining additional information that could be considered during an appeal. The blood specimen hould be drawn immediately, if possiblz. If a blood specimen cannot be drawn immediately, tne pros -dpri for calculating a BAC level from delayed collection of breath specimens and the extrapolation 159
of BAC results (as per i 26.24 (h) and described in Section 2.9 (i) of this appendix) must be followed for the blood specimen. All vacuum tube and' needle aswmblies uwd for blood collection must be factory sterilized. The collection site person shall ensure that they remain properly sealed until used. Amiseptic swabbing of the skin must be performed with a nonethanol antiseptic. Sterile procedures must be followed when drawing blood and transferring the blood to a storage container; in addition, the container must be sterile and sealed. 4 (20) Both the individual being tested and the collection site person shall keep urine and blood specimens in view at all times before their being sealed and labeled. If a urine specimen is split (as described in Section 2.7 (k)) and if any specimen is transferred to a second container, the collection site person shall request the individual to observe the splitting of the urine sample or the transfer of the specimen and the placement of the tamper evident seal over the container caps and down the sides of the containers. (23) The individual shall initial the identifiedon labels on the specimen bottles for the purpose of certifying that it is the specimen collected from him or her. The specimen bottles must be securely sealed to prevent undetected tampering. The individual must also be asked to read and sign a statement on the chain of custody form certifying that the specimens l identified as having been collected from him or her arc in fact the specimens he or she provided. 160-
o (24) Agreement of the MRO, other designated medical professional. or a higher level mnervisor of the collection site. person, must be obtained in advance of each decision to obtain a urine specimen under direct observation as specified in Section 2.4 (g)(15). 4 (25) The collection site person shall complete the chain of custody forms for both the primary specimen and the split specimen, if collected, and shall certify proper completion of the collection. (27) While any part of the above chain of custody procedures is being performed. it is essential that the specimens and custody documents be under the control of the involved collection site person. The collection site person must not leave the collection site in the interval between presentation of the specimen by the individual and r,ecurement of the specimens with identifying labels bearing the individual's specimen identification numbers and seals initialled by the individual. If the involved collection site person leaves his or her work station momentarily, the sealed specimens and chain of custody forms must be taken with him or her or must be secured. if the collection site person is leaving for an extended period of time, the specimens must be packaged for transfer to the laboratory before he or she leaves the collection site. (h) " Collection Control," To the maximum extent possible, collection site personnel must keep the individual's specimen containers within sight both before and after the individual has urinated or provided a blood specimen. After the specimen is collected and 161
. - - _ _ _ _ - - _ -..-.-.- - . - - - - . _ - - . ~ - - - . . . - - -
j O i whenever urine specimens are split, they must be properly sealed and labated to prevent l undetected tampering. The collection site person shall sign or initial and date the specimer. seal. A chaindf custody fonn must be used for maintaining control and accountability of j i cach specimen including split specimens from the point of collection to final disposition of the specimen. The date and purpose must be documented on the chain of custody form each time , a specimen is handled or transferred, and every individaal in the chain of custody must be l identified. Every effort must be made to minimive the number of persons handling specimens. , (i) " Specimen Preparation and Transportation to Laboratory or Testing Facility." l Collection site personnel shall arrange to transfer the collected specimens to the drug testing $ laboratory or licensee testing facility. To minimize false negative results from specimen l [ degradation, specimens must be sent to the HilS certified laboratory as soon as reasonably ! possible but in no case should the time between specimen shipment and receipt of the I specimen at the HHS certified laboratory exceed 48 hours, or the time between shipment and screening test at the HilS-certified laboratory exceed 72 hours. Collected urine specimens must be shipped to the llHS certified laboratory, or cooled to not more than 6 degrees < centigrade (42.87), within 6 hours of collection. Scaled and labeled specimen bottles being I transferred from the collection site to the drug testing laboratory mum be placed in a second, tamper evident shipping container which must be designed to minimize the pouibility of damage to the specimen during shipment (e.g., specimen boxes, padded mailers, or bulk insulated shipping containers with that capability) so that the contents of the shipping j containers are no longer accessible without breaking a tamper-evident seal. The collection site 162 3
r personnel shall ensure that the chain-of custody documentation is attached to each urine j _ specimen bottle. l l i 4 (J)" Failure to Cooperate." If the individual refuses to cooperate with the urine -l collection or breath analysis process (e.g., refusal to provide a complete specimen, complete paperwork, initial specimen), then the collection site person shall inform the appropriate t authority and shall document the non-cooperation on the specimen chain of-custody form. . The failure to cooperate must be reported immediately to the Medical Review Officer, the '. : t FFD Program Manager, or to other management having a need to know, as appropriate, for further action. The provision of a blood specimen for use in an appeal of a positive breath test for alcohol must be entirely voluntary, and must be at the indivioul's option. . l
- 25. In Section 2.5 of Appendix A to Part 26, paragraph (a)(5) is revised to read as follows: ,
2.5 HHS-certined Laborstv.y Personnel. (a) (5) This individual shall be responsible for the laboratory's having a procedure manual which is complete, up to-date, available for personnel performing tests, and followed by those personnel. The procedure manual must be reviewed, signed, and dated by this responr.ible individual whenever procedures are first placed icto use or changed or when a new individual assumes responsibility for management of the laboratory. Copies of all procedures and dates , 163
f on which they are in effect must be maintained. . (Specific contents of the procedure man! are described in Section 2,7 (p) of this appendix). s
. . 1 l
h i
- In Section 2.6 of Appendix A to Part 26, paragraph (a) is revised to read as follows:
- 26. r 2.6 Lleensee Testing Faellity Persossel. f (a) " Day to Day Management of Operations." Any licensee tewing facility shall have an individual to be responsible for day to day operations and to supervise the testing _
technicians. - This individ6al(s) shall ha<e at least a bachelor's degree in the chemical or - biological sciences, medical technology, or equivalent. He or she shall have training and , experience in the theory and practice of the procedures used in the licensee testing facility. . resulting in his or her thorough understanding of quality control practices and procedures; the review, interpretation, and reporting of test results; maintenance of chain of custody; and proper remedial actions to be taken in response to daecting aberrant test or_ quality control results, i
. . . .- t .
- 27. - Section 2.7 of Appendix A to Part 26, paragraphs (e) through (o) are redesignated (f)
?
through (p), new paragraphs (c), (f) (3),~ (g) (6), and (p) (6) are added, and paragraphs (bXI), 4 (c),2(d), (fXI), (gXI), (2), (3), and (5), (hXI), (2), (3), (5), and (6), (i), (j),-(k), (mX2), (n), L and (pKI), (2), and (3Xii) are revised to read as follows: l
,ee,.z w e, - - , , - ,,.-..v.-. ;,.. - . .a.
+
[
+
2.7. Leberatory sad Testing Facilky Aanlysis Praeedores. : j i i i (b) " Receiving." ; a f (1) When a shipment of specimens is received, laboratory and the licensee's testing- ! 1
- facility personnel shall inspect each package for evidence of possible tampering and compare information on specimen containers within each package to the information on the i
- accompanying chain-of custody forms. Any direct evidence of tampering or discrepancies in i
i the information on specimen containers and the licensee's chain-of custody forms must be reported by the HHS-certified laboratory within 24 hours to the licensee and must be noted on 4 the laboratory's chain-of custody form which must accompany the specimens while they are ; in the laboratory's possession. Indications of tampering with specimens at a testing facility. e operated by a licensee must be reported within g hours to wnior licensee management.
+
r (c)"Short Term Refrigerated Storage." Specimens that do not receive a screening test
! and, if appropriate, a confirmatory test within one day of arrival at the HHS-certified laboratory, or are not shipped within 6 hours of collection ftom the licensee's collection or -
testing facility,'as well as any retained split specimens, must be placed in secure refrigeration l
' r i
units or other means of securely maintaining the specimens in a chilled condition until testing 6
- 165- .
4
-..r, , -._s-.._ r - ,-~.._, 2, . . - - . _ , , ~ , - . . . . . _ _ _ . , , - _ . . . , . . , - . . . . _ , . _ . _ _ . - . . . _ - . , _ . , . _ - _ - -
_m _ ~ _ _ _ _ ___ - _ _ . _ . _ _ _ _ _ _.__ . _ _
.j i
or shipment. Temperatures must not exceed 6'C/43'F. Contingency measures must be available to maintain the specimens in a chilled state in case of prolonged power failure.- (d) " Specimen Processing." Urine specimens identified as unconfirmed positive or as 1 questionable for adulteration or dilution by a licensee's testing facility must be shipped to an HilS-certified laboratory for testing. Laboratory facilities for drug testing will normally process urine specimens by grouping them into batches.- The number of specimens in each , batch may vary significantly depending on the size of the laboratory and its workload. When
. conducting either screenin;', or confirmatory tests at either the licensec s testing facility or an i HHS certified laborsicry, every batch must contain an appropriate number of standards for calibrating the instrumentation and a minimum of 10 percent controls. Both quality control and blind performance test specimens must appear as ordinary specimens to laboratory analysts. Special processing may be conducted to analyze specimens suspected of being adulterated or diluted (including hydration). Any evidence cf adulteration or dilution, and any
- detected trece amounts of drugs or metabolites, must be reported to the Medical Review Officer. The Medical Review Officer shall report any adulteration or dilution evidence
. (excluding hydration resulting from an acceptable reason) to management immediately, ,
- (e) " Determining Specimen Validity." Specimens must be tested at a licensee's testing facility, if the "censee conducts screening tests, and at an HHS-certified laboratory to 1
= determine their validity and to detect evidence of adulteretion' or dilution. At a minimum, i
such testing must include analysis of specific gravity (SG) before being subjected to screening testing. Devices used to determine validity of the specimen must be accurate and not e contaminate the specimen. A specimen acceptable for testing using the cut-off levels in { 2.7 l 166
.h_ '-'
-(f) (1) and i 2.7 (g)-(2) has a specific gravity greater than 1,003 and is free of detectable
^
.Ladulterants.- Specimens determined to be of questionable validity;that show evidence of dilution'must be subject to both screening and confirmation testing using the limit of detection j f
(LOD) that the laboratory is capable of performing. If the specimen's specific gravity (SG) is j7 " less than 1.001, or if there is reason to believe that the specimen has been adulterated, the - . l laboratory need not conduct LOD testing and must report dw possibly adulterated or diluted l condition to the Medical Review Officer. When the MRO cannot determbe P che specimen is valid or invalid, another specimen must be collected as soon as possible under the . g . i provisions of f 2,4 (f). ; 1 (f) " Onsite and Laboratory Screening Tests." , (1) For the analysis of urine specimens, any screening test performed by a licensee's [ testing facility and the screening test performed by an HHS-certified laboratory must use an immunoassay'which meets the requirements of the Food and Drug Administration for commercial distribution. The screening test of broth for alcohol performed at the collection site must use a breath measurement device which meets the requirements of Section 2.7 (p) (3) of this appendix. The following initial cut-off levels must be used when screening 4 specimens to determine whether they are neg tive for the indicated substances: L _
'^
n
- 167 -
e w = , y- s- ,- e e e-- <v-- --w-e a,s-er -- -e ,--w* - ,, e- . e- ,--m- -r ---n -- --
I Sc'reening test cut-off level (ng/ml) l Marijuana metabolites >50 Cocaine metabolites 300-Opiate metabolites' -300 Phencyclidine - 25 Amphetamines ' I,000 Alcohol 2 0.04% BAC
' 25 ng/ml is immunoassay specific for free morphine.
2 Percent, by weight, of alcohol in a person's blood shall be based upon grams of alcohol per 100 milliliters of blood or grams of alcohol per 210 liters of breath. . In add tion, licensees may specify more stringent cut-off levels. In such cases, the -- results of HHS screening tests must be reported for both levels. Only the more stringent tests need be conducted, and the results for the cut-off levels above may be calculated. (3) Multiple screening tests (also known as rescreening) for the same drug class may be pe formed on (i) unconfirmed positive specimens (e.g., an unconfirmed positive for amphetamines) only when needed to reduce the effect of possible cross reactivity due to structural artalogs; (ii) those specimens where a valid analytical result cannot be obtained - using one particular immunoassay technique due to interference in the assay (e.g., prescription
~ medication); or (iii) unconfirmed positive specimens that appear to have a high concentration 168
4 of drugs.or metabolites to determine an appropriate dilution requirement for GC/MS confirmation analysis. t (g) " Confirmatory Test." : (1) Specimens which test negative as a result of a screening test must be reported as , 4 negative to the licensee and will not be subject to any further teming unless special processing of the specimen is desired because adulteration or dilution is suspected. (2) All urine specimens identified as unconfirmed positive on the screening test performed by a HHS-certified laboratory must be confirmed using gas chromatography / mass spectrometry (GC/MS) techniques at the cut-off values listed in this paragraph for each drug, or at the cut-off values required by the licensee's unique program, where differences exist. All confirmations must be made by quantitative analysis. Concentrations which exceed the linear region of the standard curve must be documented in the laboratory record as " greater than highest standard curve value." 169
;_.._ _ . _ _ . . _ . , . . . _ _ . _ . . _ . _ _ .2 _ _ .
l I l Confirmatory test cut off level (ng/ml) Marijuana metabolite' 15 Cocaine metabolite 2 150 Opiates: Morphine 300 Codeine 300 Phencyclidine 25 Amphetamines: Amphetamine 500 , Methamphetamine' 500 Alcohol d O 04% BAC
' Delta 9-tetrahydrocannabinol 9 carboxylic acid.
'Benzoylecgonine.
8 Specimen must also contain amphetamine at a concentration 2 200 ng/ml. d Percent, by weight, of alcohol in a person's blood shall be based upon grams of alcohol per 100 milliliters of blood or grams of alcohol per 210 liters of breath, in addiJan, licensees may specify more stringent cut-off levels. In such cases, the results must be reported for both levels. Only the more stringent tests need be conducted, and the results for the cut-off levels above may be calculated. d (3) The analytic procedure for analysis of blood specimens voluntarily provided by _ individuals testing positive for alcohol on a breath test must be gas chromatography analysi s. e -n o e e 170
- (5) Confirmatory tests for opiates must include a test for 6-acetylmorphine (AM), ;
8
'(6) Specimens that have a positive GC/MS test result for amphetamines must be tested for the d and I isomers. The results of this additional test must be reported to the MRO. >
Laboratory quality control and inspection criteria must be included for this additional test. (h) " Reporting Results." . (1) The HHS-certified laboratory shall report test results to the licensee's Medical
- Review Officer within 4 working days (6 for suspected amphetamines) after receipt of the specimen by the laboratory, Before any test result is reponed, the results of screening tests, confirmatory tests,' and quality control data, as applicable, must be reviewed and the test -
certified as an accurate repon by the responsible individual at the laboratory. The repon must
- identify the substances tested fcr, whether positive or negative; the cut off(s) for each; the specimen number assigned by the licensee; any indications of tampering, adulteration, or dilution that may be present; and the drug testing laboratory specimen identification number.
(2) The HHS-certified laboratory and sny licensee testing facility shall repon as
- negative all specimens, except suspect rpecimens being analyzed under special processing, which are negative on the screening test or negative on the confirmatory test. Specimens testing positive on the confirmatory analysis must be reponed positive for a specific-substance. Except as provided in i 26.24(d), unconfirmed positive results of screening testing 171
-1 i
I at the licensee's testing facility will not be reporthd to licensee management. The MRO's i staff may perform routine administrative support functions, including receipt of test results ; Land scheduling interviews for the MRO. ,
. (3) The Medical Review Officer may routinely obtain from the HHS-certified laboratory, and the laboratory must provide, quantitstion of test results. The Medical Review
. Officer may only disclose quantitation of test results for an individual to licensee managemer!t if required in an appeals process, or to the individual under the provisions of f 26.29 (c).
. (This does not preclude the provision of program performance data under the provisions of 10 CFR 26.71 (d).)- Quantitation of negative tests for urine specimens shall not be disclosed, I
! - except where deemed appropriate by the Medical Review Officer for proper disposition of the results of tests of suspect specimens. Alcohol quantitation for a blood specimen must be p*ovided to licensee management with the Medical Review Officer's evaluation. (5) The laboratory shall retain the origi tal chain-of-custody form and must send only to the Medical Review Officer certified true copies of the original chain-of custody form and the test report.- . In the case of a laboratory-confhmed positive or special processing of suspect. specimens,' the document must be signed by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the 172
- i i i validity of the test reports. Laboratones must retain these documents consistent with the requirements contained in Section 2.2 (a) of this appendix. ,
i - (6) The HHS certified laboratory and the licensee's testing facility shall provide to the licensee official responsible for coordination of the fitness for-duty program a monthly statistical summary of urinalysis and blood testing and shall not include in the summary any
- personal identifying information. Initial test data from the licensee's testing facility and the . -
HHS certified laboratory, and confirmation data from HHS-certified laboratories must be included for test results reported within that month. Normally this summary must be forwarded frora HHS-certified laboratories by registered or certified mail and from the licensee's testing facility not mor: than 14 calendar days after the end of the month covered by the summary. The summary must contain the following information: 4 (i) Screening Testing:
-(A) Number of specimens received;
.(B) Number of specimens reported out; and (C) Number of specimens ser:ened positive for:
(1) Marijuana metabolites (2) Cocaine metabolites; (1) Opiate metabolites; (4) Phencyclidine; (1) Amphetamines; and 173 h T+ +- T - e t 4 *.y+y-
- T m r me- r-
j (fi) Alcohol. e , J
' (i) "Long-Term Storage." Long term frozen storage (-20* C or less) ensures that any
! urine specimens that have been associeted with personnel actions will be available for any necessary retest during administrative or disciplinary proceedings. Unless otherwise-authorized in writing by the licensee, HHS-certified laboratories shall retain and place in properly secured long term frozen storage for a minimum of 1 year all specimens that have
- been confirmed positive, or that have been adulterated or diluted. Within this 1-year period, a
- licensee or the NRC may request the laboratory to retain the specimen for an additional period of time. !f no such request is received, the laboratory may discard the specimen after the end 6f 1 year. The laboratory must maintain any specimens under legal challenge for an j - indefinite peHM. Any split specimens retained by the licensee must be transferred into long-term storage upon determination by the Medical Review Officer that the specimen has a laboratory confinned positive test.
- (j) " Retesting Specimens." Because some analytes deteriorate or are lost during freezing and/or storage, quantitation for a retest is not subject to a specific cut-off requirement
. but must provide data sufficient to confirm the presence of the drug or metabolite. For the retesting of specimens that have been dctermined to have been adulterated or. diluted, the i retest need only confirm that the specimen is not valid.
174 v- , .- er , ,, ,.ev -
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- - . - _ - .- - .- - . . . ~ ..- - - - - - . . - - .-.-
. (k) " Split Specimens."' Urine specimens may be split, at the licensee's discretion, into two parts at the collection site. One half of such specimens (hereafter called the primary specimen) must be analyzed by the licensee's testing facility or the HHS-certified laboratory 6
for the licensee's purposes as described in this appendix. The other half of the specimen
+
(hereafter called the split specimen) may be withheld from transfer to the laboratory, scaled, and stored in a secure manner by the licensee until all processing of the primary specimen has been completed. If the primary specimen is determined to be negative and free of any . evidence of subversion, the split specimen in storage may be destroyed. -If the unconfirmed I positive result of a screening test has been confirmed, or if the primary specimen is
' determined to have been subject to adulteration, dilution, or other means of testing subversion. ,
the tested iadividual may request in a timely manner (as established by the licensee, but not to 4 be restricted to less than 72 hours from the time of the individual's notification of the screening test result) that the split specimen be tested. The individua! must be informed of e this option. The split specimen must be forwarded on the day of the request to another HHS. certified laboratory that did not test the primary specimen. The chain-of-custody and testing procedures to which the split specimen is subject must be the same as those used to test the primary specimen and must meet the standards for retesting specimens. In other words, the _ quantification of the result is not subject to a pecific cut off requirement but must provide
; data sufficient to confirm the presence of the drug or metabolite (Section 2.7 (j) of this appendix). The quantitative results of any second testing process shall be made available to
- the Medical Review Officer and to the individual tested. Except as noted in this section, all 4
S E < 175 L
.4 l other requirements of this appendix applicable to primary specimens shall also be applicable
- to split specimens, ,
4 t _ (m) %borstory Fucilities." s . . . (2) HHS certified laboratories must have the capability, at the same laboratory premises, of performing screening and confirmatory tests for cach drug and drug metabolite for which service is offered and for blood analysis for alcohol content (BAC). Any licensee testing facilities must have the capability, at the same premises, of performing screening tests for each drug and drug metabolite for which testing is conducted. Breath tests for alcohol may be performed at the collection site. (n) " Inspections and Audits." The NRC and any licensee utilizing an HHS-certified laboratory reserves the right to inspect or audit the laboratory at any time. Licensee contracts with HHS-certified laboratories for' drug testing and analyses of blood for alcohol content
- (BAC), as.well as contracts for collection site services, must permit the NRC and the licensee to conduct unannounced inspections and audits and to obtain all information and documentation reasonably relevant to the inspections and audits. Licensee contracts with 176 e
e,we--= r n n--
t HHS cenified laboratories must also provide the licensee and the NRC with the ability to obtain copies of any documents, including reviews and inspections pertaining to the Itboraton's certification by HHS, and any other data that may be needed to assure that the laboratory is performing its testing and quality control functions properly and that laboratory ' staff and procedures meet applicable requirements. Annual licensee inspections and audits of HHS-certified laboratories must include review ofinspection reports made under the HHS-cenification program but need not duplicate areas covered by the HHS inspection in , addition, before the award of a contract, the licensee shall carry out pre award inspections and evaluation of the procedural aspects of the laboratory's drug testing operation. If an HHS-certified laboratory loses its cenification, in whole or in pan, a licensee is permitted to immediately use an HHS-certified laboratory that has been audited by another NRC licensee having a compatible drug panel and cut off standards. The licensee shall audit the newly contracted HHS-cenified laboratory within three months. The NRC reserves the right to inspect a licensee's testing facility at any time. (p) " Additional Requirements for HHS Certified Laboratories and Licensees' Testing Facilities." (1) " Procedure manual." Each laboratory and licensee's testing facility shall have a procedure manual which includes the principles of each test, preparation of reagents, standards 177
I and controls, calibration procedures, derivation of results, l'incarity of methods, sensitivity of the methods, cut off values, mechanisms for reporting results, controls, criteria for Lunacceptable specimens and results, remedial actions to be taken when the test systems are outside of acceptable limits, reagents and expiration dates, and references. Copies of all procedures and dates on which they are in effect must be'maintainoj as part of the manual. Each HHS-certified laboratory shall retain a copy ofits latest procedure manual as a record until at least 2 years after it is no longer under coi. tract ta an NRC licensee to test specimens, of urine for drugs. Each licensee shall retain a copy of its latest procedure manual as a record until'it is no longer conducting on-site testing of specimens of urine for drugs. Superseded material must be retained for at least three years. (2) " Standards and controls." HHS-certified laboratory standards shall be prepared with pure drug standards which are properly labeled as tt, content and concentration. The standards must be labeled with the following dates: when received; when prepared or opened; s when placed in service; and expiration date. All standards used to calibrate alcohol breath analysis equipment and equipment used at licensees' testing facilities for conducting screening tests must be current and valid for their purpose. f2) Instruments and equipment. e' $ -$ $ $ e r 178 I
1..
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(ii) Alcohol breath analysis equipment must be an evidential grade breath alcohol
. analysis device of a brand and model that conforms to National Highway Traffic Safety
; Administration (NHTSA) standards (49 FR 48855; December 14,1984 or 58 FR 48705; September 17,1993) and to any applicable State statutes.
1 A 'I M (6) " Restrictions." The laboratory shall not enter into any relationship with a . licensee's MRO that may be conr. rued as a potential conflict ofinterest or derive any financial benefit by having a licensee use a specific MRO.
- 28. In Section 2.8 of Appendix A to Part 26, paragraphs (a), (b), (c), and (e) are revised, and new paragraph (f) is added to read as follows:
t 2,8 Quality Assurance and Quality Control. (a) " General." HHS-certified laboratories and the licensee's testing facility shall have
- a quality assurance program which encompasses all aspects of the testing process including, 4
but not limited to, specimen acquisition, chain of custody, security, reporting of results, screening and confirmatory testing, and validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed to monitor the conduct of each step of the process of testing for drugs. i
- l 179 l
't
(b) " Licensee's Testing Facility Quality Control Requirements for Screening Tests." Because all unconfirmed positive licensee facility screening tests for drugs are forwarded to an HHS-certified laboratory for screening and confirmatory testing when appropriate, the NRC does not require licensees to assess their testing facility's false positive rates for drugs. To ensure that the rate of false negative tests is kept to the minimum that the immunoassay technology supports, licensees shall perform an immunoassay test on all blind performance test specimens and submit these and a sampling of specimens screened as negative from every test run to the HHS certified laboratory. The results reported by the certified laboratory must be evaluated and appropriate corrective actions taken. The manufacturer required performance tests of the breath analysis equipment used by the licensee must be conducted as set forth in the manufacturer's specifications. (c) " Laboratory Quality Control Requirements for Screening Tests at HHS-Certified Laboratories." (1) Each analytical run of specimens to be screened must include: (i) Urine specimens certified to contain no drug; (ii) Urine specimens fortified with known standards; and (iii) Positive controls with the drug or metabolite at or near the threshold (cut-off). 180 1
.. i
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(2) in addition, with each batch of specimens, a sufficient number of standards must - be included to ensure and document the linearity of the assay method over time in the concentration area of the' cut-off. After acceptable values are obtained for the known standards, those values will be used to calculate specimen data. Implementation of procedures
.to ensure that carryover does not contaminate the testing of an individual's specimen must be documented. A minimum of 10 percent of all test specimens must be quality control specimens. Laboratory quality control specimens, prepared from spiked urine specimens of ,
determined concentration, must be included in the run and should appear as normal specimens to laboratory analysts. One percent of each run, with a minimum of at least one specimen, must be the laboratory's own quality control specimens. (c) " Licensee Blind Performance Test Procedures."
-(1) Licensees shall only purchase blind quality control materials that:
(i) Have been cenified by immunoassay and GC/MS; and (ii) Have stability data which verify performance of those materials over time. 181
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e U
- (2) During the initial 90-day period of e'ty contract with an HHS-certified laboratory (not including rewritten or renewed contracts), each licensee shall submit blind performance test specimens to 'the laboratory within the amount of at least 20 percent of the total number of specimens submitted (up to a maximum of 100 specimens) or 30 blind performance test . specimens, whichever is greater, Following the initial 90-day period, a minimum of 3 percent of all specimens (to a maximum of 25) or 10 blind performance test specimens, whichever is greater, must be submitted per quarter. Licensees should make an attempt to submit blind .
performance test specimens during the initial 90-day period and per quarter thereafter at a frequency that corresponds with the submission frequency for other specimens. (3) Approximately 50 percent of the blhd performance test specimens must be blank (i.e., certified to contain no drug) and the rear.aining specimens must be positive for one or more drugs per specimen in a distribu*. ion such that all the drugs for which the licensee is testing are included in approximately equal frequencies of challenge. The positive specimens must be spiked only with those drugs for which the licensee is testing. In addition,10 percent of the positive blind specimens must be appropriately adulterated or diluted and " spiked" to 60 perces of the cut off value to challenge the laboratory's ability to determine specimen validity, as required by Section 2.7 (e) of this Appendix. (f) " Investigation of Errors and Other Matters." e 182
. J (1) The licensee shall investigate any testing errors or unsatisfactory performance :
discovered in blind performance testing, in the testing of actual specimens, or through the processing of appeals and MRO reviews, as well as any other errors or matters that could: ! 4
- reflect adversely on the integrity of the teming process. ' The investigation must determine relevant facts and identify the root cause(s) of the testing or process error when possible. The licensee and the laboratory shall take action to correct the cause of any errors er the unsatisfactory performance that are within tlx.ir control. A record must be made and retained '
for s' minimum of three yea s of the investigative findings and the corrective action taken,
.-and, where applicable, that record must be dated and signed by the individuals responsible for the day to-day management and operation of the HHS certified laboratory. The licensee shall ,
- submit to the NRC a report of any incident and action taken or planned within 30 days of completion'of the investigation. The NRC shall ensure notification of the finding to HHS.
(2) Should a false positive error occur on a blind performan e test specimen or on a regular test specimen, the licensee shall promptly notify the NRC. The licensee shall require the laboratory to take corrective action to minimize the occurrence of the particular error in the future. If there is reason to believe the error could have been systematic, the licensee may also require review and reanalysis of previoudy run specimens. , (3) Should a false positive error be detennined to be technical or methodological, the licensee shall instruct the laberatory to submit to it all quality control data from the. batch of specimens which included any false positive specimen. In addition, the licensee shall require 183
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4 I the laboratory to retest all specimens analyzed positive for that drug or metabolite from the time of final resolution of tha error back to the time of the last satisfactory performance test cycle. This retesting must be documented by a statement signed by the individual responsible for day-to-day management of the laboratory's substance testing program. The licensee and , the NRC may require an on site review of the laboratory which may be conducted . unannounced during any hours of operation of the labortwry. Based on information provided by the NRC, HHS has the option of revoking o: 2 spending the laboratory's certification or , recommending that no further action be taken if the case is one ofless serious error in which corrective action has already been taken, thus reawnably assuring that the error will not occur again. L
- 29. Section 2.9 of Appendix A to Part 26 is revised to read as follows:
2.9 Reporting and Review of Results. (a) " Medical Review Officer shall review results." An essential part of a licensee's testing program is the final review of results. A laboratory con 5rmed positive test result does not automa'ically identify a nuclear power plaat worker as having used substances in violation of the NRC's regulations or the licensee's company policies. An individual with a detailed knowledge of possible alternate medical explanations is essential to the review of results. This review must be performed by the Medical Review Officer before the transmission of results to licensee management officials. 184
- r .< ,
4 e t , , i 4 (b) " Medical Review Omcer--qualifications and responsibilities." The Medical Review Omcer shall be a licensed physician with knowledge of substance abuse disorders. The MRO may be a licensee or contract employee.- However, the MRO shall not be an employee or agent of or have any financial interest in a laboratory or a contracted operator of an on site : testing facility _whose drug testing results the MRO is reviewing for the licensee. Additionally, the MRO shall not derive any financial benefit by having the licensee use a specific drug testing laboratory or on-site testing facility operating contractor or have any , agreement with such parties that may be construed as a potential conflict ofinterest. The role of the Medical Review Officer is to review and interpret laboratory confirmed positive test results obtained through the licensee's testing f rogram _and to identify evidence of subversion i of the testing process. The MRO is also responsible for identifying issues associated with the collection and testing of specimens, and advising and assisting management in the planning. and oversight of the overall FFD program. In carrying out this responsibility, the Medical T
- Review Officer shall examine alternate medical explanations for any laboratory confirmed positive test result (this does not include confirmation of blood alcohol levels obtained -
4 through the use of a breath alcohol analysis device). This action could include conducting a ; medical intersiew with the individual, review of the individual's medical history, or review of any other relevant biomedical factors. The Medical Review Officer shall review all medical records made available by the tested individual when a laboratory confirmed positive test could have resulted from legally prescribed medication. The Medical Review Officer shall
- not consider the results of tests that are not obtained or processed in accordance with this apoendix, although he or she may c . aider the results of tests on split specimens in making:
185-
- 4_ -!
- his or her determination,'as long as those split specimens have been stored and tested in . ,
Ii
- accordance with the procedures described in this appendix.
(c) "MRO Ver9 cation of Positive Test Results." Before making a final decision to verify a laboratory confirmed positive test result, the Medical Review Officer shall give the individual are opportunity to discuss the test result with' him or her. Following verification of a laboratory confirmed positive test result as a victation of FFD policy, the Medical Review , Offic:r shall, as provided in the licensee's policy, immediately notify the applicable employee-
~
assistance program and the licensee's management official empowered to recommend or take administrative action (or the official's designated agent). Unconfirmed test results must not be reported except as provided by 6 26.24 (d). (d) " Verification for opiates." Before the Medical Review Officer verifies a laboratory confirmed positive result as a violation of FFD policy and the licensee takes action for opiates, he or she shall determine that there is reasonable and substantial clinical evidence--in $ addition to the urine test--of unauthorized use of any opium, opiate, or opium derivative (e.g.. morphine / codeine). Clinical' evidence may incluc'e substantial evidence of a significant lack of-reliability or trustworthiness on the part of the _ worker. Clinical signs of abuse include recent needle tracks or test results that are inconsistent with the ingestion of food or medication including prescription medications containing opiates (e.g.,6-AM test); clinical signs of abuse
- also include behavioral and psychological signs of acute opinte intoxication or withdrawal.
- 186 a
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9
. 1 This requirement does not apply if the GC/MS confirmatic:t testing for opiates confirms the presence of 6-acetylmorphine.
(e) " Reanalysis authorized." Should any question arise as to the accuracy or validity of a laboratory confirmed positive test result, only the Medical Review Officer is authorized to order a reanalysis of the original specimen and such retests are authorized only at , laboratories cer.ified by HHS, The Medical Review Officer shall authorize a reanalysis of the original aliquot on timely request (as established by the licensee, but not to be restricted to less than 72 hours from the time of the individual's notification of the laboratory confirmed positive test result) of the individual tested, and shall also authorize an analysis of any split specimen stored by or for the licensee under the provisions of Section 2.7 (k) of this appendix. (f) "Results consistent with responsible substance use " If the Medical Review Officer determines that there is a legitimate medical explanation for the laboratory confirmed positive test result, and that the use of the substance identified through testing was in the manner and at the dosage prescribed, and the results do not reflect a lack of reliability or trustworthiness. then there has not been a violation of license
- policy. The Medical Review Officer shall report the test result to the licensee as negative. The Medical Review Officer shall further
- evaluate the result and medical explanation to determine if there is a potential risk to public 4
health and safety of the individual being impaired on duty from the substance or from the - 187
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medical condition. If the MRO determines that such a risk exists, he or she shall conduct a medical determination of fitness. (g) " Medical determination of fitness." (1) Occasions when a medical determination of fitness, as defined in { 26.3, must be conducted include, but are not limited to, the following: . (i) When an alternative medical explanation explains the test result but there is a basis for believing impairment on duty could exist. as described in Section 2.9 (f) of this appendix: (ii) In the evaluation of all for-cauu test results; (iii) Before making return-to-duty recommendations subsequent to a worker's removal from duty in accordance with 10 CFR 26.27 (b) or the licensee's fitness-for-duty policy; (iv) Before an individual being granted unescorted access when a statement from an individual obtained pursuant to { 26.27 (a) shows a history of substance abuse or record of prior fitness-for-duty violations; and (v) If a history of substance abuse is otherwise identified. 188
d (2) (i) If the licenshd phhsician or MRO determines that there is neither conclusive _ i evidence of a policy violation nor a significant basis for concern that the individual may be
- impaired while on duty, then he or she shall report the result as negative.
(ii) If the licensed physician or MRO determines that there is not conclusive evidence of a policy violation but that there is a significant basis for concern that the individual may be , impaired while on duty, then he'or she shall report the result as not representing an FFDl ,
. violation but as a condition under which the individual may not be able to safely and ,
competently perform duties. Because these results should not constitute a violation of the - , licensee's policy or the NRC rule, punitive actions under the rule should not be taker. based 4 upon the results. However, the licensed physician, MRO, or the licensee management personnel who are empowered to take appropriate actions shall initiate actions to ensure that any possible limiting condition does not represent a threat to workplace or public health and safety. When deemed appropriate, the matter may also be referred to the EAP. (h) Breath alcohol content indicating a blood alcohol concentration between 0.02 percent and 0.04 percent must be repo-ted to the MRO for review and evaluation. The MRO
- shall determine whether it is appropriate to extrapolate back in time to estimate the highest BAC that the worker had while on duty with the assumption that no alcohol was consumed 4 while on duty. In these cases, the MRO will calculate a range of possible peak BACs that -
+ could have existed while the worker was on duty and make a determination whether the result is a confirmed positive test for alcohol. A similar extrapolation process must be conducted for the results of an analysis of a blood specimen for alcohol, as provided by { 26.24 (h). b e 189-
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- nr.,--
s 9 q l (i) " Result scientifically insufficient."" Additionally, the Medical Review Officer, based on review of inspection reports, quality control data, multiple specimens, and other peninent results, may determine that the result is scientifically insufficient for further action and declare the test specimen negative. In this situation, the Medical Review Offber may request , reanalysis of the original specimen before making this decision. The Medical Review Officer may request that reanalysis be performed by the same laboratory, or that an aliquot of the original specimen be sent for reanalysis to an alterna:e laboratory which is certified in , 4 accordance with the HHS Guidelines. The licensee's testing facility and the HHS-certified
-laboratory shall assist in this review process as requested by the Medical Review Officer by making available the individual (s) responsible for day to-day management of the licensee's test facility, of the HHS-certified laboratory or other individuals who are forensic toxicologists or who have equivalent forensic experience in urine drug testing, to provide specific consultation as required by the licensee. The licensee shall maintain for a minimum of three f
years, records that summarize any negative findings based on scientific insufficiency and shall make them available to the NRC on request, but shall not include any personal identifying 4 information in such reports. [ Removed] - i30. . Section 3.2 of Appendix A is deleted and incorporated into { 26.29. l , 'I i I l I
- 190
- , _ - . . . . . . ~ . . , . . --, ,. -- .- .- .. -
- 9. O 11
- 31. -In Section 4.1 of Appendix A to Part 26, paragraphs (a) and (b) are revised and a new paragraph (c) is added to read as follows: ;
t 4.1 Use of HHS-eertified laboratories. . (a) Licensees subject to this part and their connactors shall use only laboratories certified under the HHS " Mandatory Guidelines for Federal Workplace Drug Testing Programs", Subpart C- " Certification of Laboratories Engaged in Urine Drug Testing for . Federal Agencies,"(53 FR 11970,11986-11989) dated April 11,1988, and subsequent - amendments thereto for screening and confirmatory testing except for screening tests at a licensee's testing facility conducted in accordance with 10 CFR 26.24(d). Information concerning the current certifiaation status oflaboratoria is available from: The Division of Workplace Programs, Substance Abuse and Mental Health Services Administration, Room 13-A 54,5600 Fishers Lane, Rockville, Maryland 20857. (b) Licensees or their contractors may use only HHS-certified laboratories that agree to follow the same rigorous chemical testing, quality control, and chain-of-custody procedures when testing for more stringent cut offlevels as rray be specified by licensees for the classes of drugs identified in this part, for analysis o rblood specimens for alcohol, and for any other.
. substances included in licensee drug panels. Because the HHS-certifiertion process does not apply to these matters, the defensibility of such tests depends on appropriate measures by licensees to assure the reported test results are valid.
191
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e (c) All contracts related to this part between licensees and their contractors and HHS-ceniDed laboratories must require implementation of all obligations of this appendix , applicable to HHS-certi6ed laboratories. 4 Dated at Rockville, Maryland, this hy of ' 1996 V For the Nuclear Regulatory Commission
'h Joh/C. Hoyfe ~ /
Jefretary of th(Commission 192 I i I i. I l t-
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