ML20207L968
| ML20207L968 | |
| Person / Time | |
|---|---|
| Issue date: | 02/26/1999 |
| From: | Jerome Murphy NRC - CENTER REVIEW GROUP |
| To: | Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| NUDOCS 9903180335 | |
| Download: ML20207L968 (200) | |
Text
_
February 26, 1999 6
MEMORANDUM TO:
William D. Tr: vers Ex;cutivs Director for Operations FROM:
Joseph A. Murphy, Chairman (Original /s/ by J. Murphy)
Committee to Review Generic Requirements
SUBJECT:
MINUTES OF THE CRGR MEETING NUMBER 332 The Committee to Review Generic Requirements (CRGR) met on Friday, November 20,1998,
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from 10:00 a.m. to 12:00 noon. Attadment 1 contains the list of attendeer.
J. Roe and L. Bush, both of NRR, briefed CRGR on the draft final Fitness for Duty Rule (10 CFR 26). The staff focused on an overview of the draft final rulemaking package which was later submitted for CRGR review and endorsement. The presentation material used by the staff at the meeting is included as Attachment 2. The staff indicated that the rulemaking was the most appropriate vehicle to promulgate numerous needed improvements to the rule which have been identified over the years. However, the Committee questioned appropriater sss of application of the compliance backfit to several proposed changes. Furthermora,.ne Committee insisted that before formal CRGR review, the staff obtain the required NMSS concurrence on the proposed rule as it applies both the reactor as well as nuclear materials facilities. Subsequently, this rulemaking was scheduled for formal review at CRGR Meeting No. 334, which was hold on December 16,1998. The minutes of th.ht meeting w::e issued on December 31,1998.
In accordance with the EDO's July 18,1983 directive conceming " Feedback and Closure of CRGR Review", a written response is required from the cognizant office to report agreement or disagreement with the CRGR recommendations in these minutes. The response is to be forwarded to the CRGR Chairman and if there is disagreement with the CRGR recommendations, to the EDO for decision making.
Questions conceming these meeting minutes should be referred to Raji Tripathi (415-7584).
i Attachments: As stated cc:
Commission (5)
SECY M.Knapp,DEDE F. Miraglia, DEDO J. Lieberman, OE M. Springer, ADM H. Bell, OlG K. Cyr, OGC J. Lark;ns, ACRS H. Miller, R-l
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L. Reyes, R-il J. Dyer, R-Ill f
E. Merschoff, R-IV C. Paperiello, NMSS A. Thadani, RES S. Collins, NRR J. Lieberman, OE D. Matthews, NRR Q \\ "@
Distribution:
- File Conier 'w/attch.)_ PDR (NRC/CRGR)
CRGR SF CRGRCF RTripathi ~~
JMitchell JJohnson, OCM Streby BSheron ETen Eyck DDambly JJohnson, Ril GMizuno GWest Tquay RAlbert DISK / DOCUMENT NAME: S:\\CRGR\\MITS-332.WPD To recorve a copy. Indicate "C* = Copy w/o attachmenvenclosure; *A* a Copy with attachment / enclosure "N" a No copn NO MARK = NO COPYi OFC CRGR C
C:CR%,
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,f NAME RTripathi DATE k /82 /99 b
! OFFICIAL RECORD COPY(j.{ { F 1 / I b ( -
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UNITED STATES j
NUCLEAR REGULATORY COMMISSION t
WASHINGTON, D.C. 30806 4001 49.up +
February 26, 1999 MEMORANDUM TO:
William D. Uavers Executive Director for Operations FROM:
Joseph A. Murphy, Chairman
/
/
Committee to Review Generic qui ments
SUBJECT:
MINUTES OF THE CRGR MEETING NUMBER 332 The Committee to Review Generic Requirements (CRGR) met on Friday, November 20,1998, from 10:00 a.m. to 12:00 noon. Attachment 1 contains the list of attendees.
J. P.oe and L. Bush, both of NRR, briefed CRGR on the draft final Fitness for Duty Rule (10 CFR 26). The staff focused on an overview of the draft final rulemaking package'which was later submitted for CRGR review and endorsement. The presentation material used by the siaff at the meeting is included as Attachment 2. The staff indicated that the rulemaking was the most appropriate vehicle to promulgate numerous needed improvements to the rule which have j
been identified over the years. However, the Committee questioned appropriateness of application of the compliance backfit to several proposed changes. Furthermore, the Committee insisted that before formal CRGR review, the staff obtain the required NMSS concurrence on the proposed rule as it applies both the reactor as well as nuclear materials facilities. Subsequently, tHs rulemaking was scheduled for formal review at CRGR Meeting No. 334, which was held on i
December 16,1998. The minute's of that meeting were issued on December 31,1998.
in accordance with the EDO's July 18,1983 directive conceming " Feedback and C!osure Of CRGR Review", a written response is required from the cognizant office to report agreement or disagreement with the CRGR recommendations in these minutes. The response is to be forwarded to the CRGR Chairman and if there is disagreement with the CRGR recommendations, to the EDO for decision making.
Questions conceming these meeting minutes should be referred to Raji Tripathi (415-7584).
Attachments: As stated cc:
Commission (5)
SECY M. Knapp, DEDE F. Miraglia, DEDO J. Lieberman, OE M. Springer, ADM H. Bell, OlG K. Cyr, OGC J. Larkins, ACRS H. Miller, R-l L Reyes, R-Il J. Dyer, R-ill E. Merschoff, R-IV C. Paperiello, NMSS A. Thadani, RES S. Collins, NRR J. Lieberman, OE D. Matthews, NRR 4
m
e an Attendance List CRGR No. 332 Meeting (November 20,1998)
CRGR MEMBERS NRC STAFF T. Martin (Chairman)
S. Treby, OGC F. Miraglia J. Roe, NRR J. Murphy L. Bush, NRR D. Dambly G. Mizuno, OGC E. TenEyck for M.1;napp T. Quay, NRR J. Johnson (via video conferencing)
R. Albert, NRR G. West, NRR CRGR STAFF C'lGR STAFF R. Tripathl N. Dudley l
i ATTACHMENT 1
Minutes of CRGR Meeting No. 332, November 20,1998 t
1 BRIEFING MATERIAL USED BY THE STAFF 4
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i NOTE TO:
CRGR FROM:
Jack Roe The Fitness For a Final Rulemaking package is extensive. Considering the size, I have A recommended review approach that will allow you to efficiently review the package. The
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approach fo%ows:
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1.
Read the Commission Paper (4 pages) j 2.
Read MText of Rule showing recommended changes
). This will give you a good picture of the changes made to the rule in cordaxt other rule requirements.
3.
ReadM, Analysis of the Application of the Backfit Rule to the Revisions to the Fitness-For-Duty M This is an important document. The grouping of the proposed revisions in this document is the same as the grouping in the Statement of Consideratiora of the proposed rule.
Group i Adoption of National Standards Group 11 Reduction in Burden (red tab)
Group 111 Other Worthwhile Changes (yellow tab)
If the Commission wanted to select only certain changes recommended (and not select others),
they could use this document as a roadmap.
This document was
. The backfit evaluation was based on 6 classifications (see pages 5,6). Several changes were to " reflect the originalintent of the rule', for these the staff and OGC went back to the original rule and SOC, to assure that there was sufficient information to mal:e that statement.
1 Loren Bush commented on the rule. I have reviewed his letter and the Draft Responses to Public Comments, Attachment D. I have no issue with our response. The sections are 3.1,3.2, 4.2.1, 8.1.2, 9.5.1,18.2.3,19.1.1,19.1.3, and 19.2.5 4.
Briefly review the other documents.
We plan to brief the Comrinssioner's TA soon after they receive the Commission Paper.
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llie staff has determined that each revision fits into at leet one of the following classification $
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l 1) rinrificatinne. Several revisions would clarify current requirements to assure consistent understanding and implementation of the Commission's original intent for these requirements. Inquiries from licensees, attorneys, and NRC i=r+3is during the past eight years about the geific meaning of certain rule sections indicate that the current wording of those sections does not clearly
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convey the Commission's original intent. The staff has responded to these k
inquiries by providing verbal guidance as to the Commission's intent and the staff is confident that most licensees are now properly implementing these requirements. However, since the inquiries continue, clarifications are deemed necessary. Without changing the requirements stated in these sections, these revisions would remove the ambiguities that produced the licensees' uncertainty.
The revisions would rninimize the possibility for any future confur'.on, uncertainty, and mispei% on. According to an Office of Gene al Council G
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(OGC) memo interpreting the Backfit Rule, the rule does not apply to rule revisions that leave current requirements unchanged (memo from M. G. Malsch to Commissioner Asselstine, January 23,1986). Hanniise the revisions clarify, but do not change current requirements, the staff concludes that the revisions are not backfits as defined in 10 CFR 50.109(a)(1).
2)
Adminittative mattert. Revisions such as correction of typographic errors, correction ofinconsistencies, relocating requirements from one section to another, and combining existing requirements into a single section, are administrative matters which, as the Bacyftring Guidelines document notes, are i
not subject to Backfit Rule requirements.
3)
Permittive Relaratinne These revisions are not subject to the Backfit Rule's
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requirements because they are permissive relaxations of current requirements (i.e., licensees are free to either comply with current requirements or adopt the relaxed requiren4cnts as an alternative). Several revisions will provide licensees with the opportunity to reduce costs but do not require licensees to adopt a change. As the Backpftring Guidelines document notes, the Backfit Rule does
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i not apply to permissive relaxations of regulatory burden.
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4) infnemntinn en11etinn and wnnetine mneirementt. Information Collection and reporting requirements are not considered +o be backfits as set forth in the Committee to Review Generic Requirements (CRGR) charter. It should be noted that all information collection and records retention requirements contained I
in this rulemaking have been approved by the Office ofManagement and Budget (OMB) approval number 3150-0148, and that the OMB submittal with respect to this rule contains a analysis of the costs and burdens associated with the information collection and reporting requirements contained in the rule.
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5) c'nmn11.ne, nr,ngnne. Dese revisions fit under the Backfit Rule's compliance exception. His excr: '.on encompasses rule revisions that are necessary to bring licensees into compliance with existing Commission requirements or the Commission's clearly stated intent in promulgating the requirement. The staff is aware that some licensee FFD programs do not currently fully comply with certain Part 26 requirements, sometimes because of differences in interpretation l
of ambiguous language in the regulations. Therefore, the purpose of some of the proposed revisions is to restate or otherwise clarify the requirements so that these licensees' FFD programs may be brought into compliance with those particular requirements. In addition, some of the proposed revisions modify current requirements where there is evidence that the current version of the
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standards is not achieving the purpose that the Commission had when it originally promulgated the rule.
6)
Wncthwhile (%nneee tn he AAnntaA me Reelent Witte Fvmrainne. De staff recommends that the Commission consider worthwhile revisions for promulgation as exceptions to the Backfit Rule as authorized by the June 30, 1993 SRM discussed above. These worthwhile revisions neither fit into one of i
the three exceptions in the Backfit Rule (10 CFR 50.109(a)(4)(i) through (iii)),
nor can the staff conclude that the change represents a substantial increase in safety whose costs arejustified in view of the increased protection.
Accordingly, the staff recommends that these worthwhile changes be adopted as exceptions to the Backfit Rule.
i NOTE: Many of the worthwhile changes are recommended to clarify, or ensure compliance with, an oripani Commission intent that was not explicitly documented, and therefore cannot bejustified as " compliance exceptions" under
, Section 50.109(a)(4)(i).
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ATTACHMENT B TEXT OF RULE SHOWING RECOMMENDED CHANGES W
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m 9/23/98 Version TITLE 10-ENERGY CHAPTER l-NUCLEAR REGULATORY COMMISSION
' PART 26-FITNESS FOR DUTY PROGRAMS-Table of Contents GENERAL PROVISIONS Sec.
26.1 Purpose.
26.2 Scope.
26.3 Definitions.
26.4 Interpretations.
26.6 Exemptions.
NElWW 26.8 information collection requirements: OMB approval.
GENERAL PERFORMANCE OBJECTIVES 26.10 General performance objectives.
PROGRAM ELEMENTS AND PROCEDURES 26.20 Writte.. policy and procedures.
26.21 Policy communications and awareness training.
26.22.Trainir,9 of supervisors and escorts.
26.23 Contractors and vendors.
26.24 Chemical and alcohol testing.
26.25 Employee assistance programs (EAP).
i 26.27 Management actions and sanctions to be imposed.
26.28 Appeals.
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26.29 Protection ofinformation, j
l INSPECTIONS, RECORDS AND REPORTS I
26.70 inspections.
26.71 Recordkeeping requirements.
26.73 Reporting requirements.
AUDITS 26.80 Auo'its.
ENFORCEMENT I
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26.90 Violations.
26.91 Criminal penalties.
APPENDo( A TO PART 26-GU!DELINES FOR DRUG AND ALCOHOL TESTING PROGRAMS AUTHORITY: Secs. 53, 81,103,104,107,161, 68 Stat. 930, 935, 936, 937, 948, as amended, sec. 1701,106 Stat. 2951,2952,2953 (42 U.S.C. 2073,2111,2112,2133,2134, 2137, 2201, 2297f); secs. 201, 202, 206, 88 Stat.1242,1244,1246, as amended (42 U.S.C.
5841, 5842, 5846).
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GENERAL PROVISIONS
$ 26.1 Purpose.
This part prescribes requirements and standards for the establishment and maintenance of certain aspects of fitness-for-duty [Ff51[ programs and procedures by the licensed nuclear power industry, and by licensees authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM).
5 26.2 Scope.
(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!
dj hall persons granted unescorted access to nuclear power plant protected areas!
M to43icensee, vendor, or contractor personnel required to physically report to a licensee's Technical Support Center (TSC) or Emergency Operations Facility (EOF) in accordance with licensee emergency plans and procedures;, amHo (3) SSNM licensee and transporter personnel who:
(4% Are granted unescorted access to Category lA Material; (iMilj Create or have access to procedures or records for safeguarding SSNM; (S)$11) Make measurements of Category lA Material; (4){iv) Transport or escort Category lA Material; or (6)[h Guard Category lA Material {W l E IT D If6555i5~p5Eid5Ei$ M g#iiKWiinisuitiMuiiisiinisnWeliiiiUsiiiiiiiTWRiiE~diaisiEEECBfiWo y
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$I O USI E iE biiA 5I E N E E M E MENf6$%iiili66MMW[5silecti6FI
- (b) The regulations in this part do not apply to NRC employees, to law enforcement personnel, or offsite emergency fire and medical response personnel while responding onsite, or l
SSNM transporters who are subject to U.S. Department of Transportation drug or alcohol fitness L
programs that require random testing for drugs and alcohol. The regulations in this part also do l-not apply to spent fuel storage facility licensees or non-power reactor licensees who possess, l
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14
use, or transport formula quantities of irradiated SSNM as these materials are exempt from the Category i physical protection requirements as set forth in 10 CFR 73.6.
(c) Certain regulations in this part apply to licensees holding permits to construct a nuclear power plant. Each construction permit holder, with a plant under active construction, shall comply with $$26.10,26.20,26.23,26.70, and 26.73 of this part; shall implement a chemical testing program, including random tests; and shall make provisions for employee assistance programs, imposition of sanctions, appeals procedures, the protection of information, and recorJkeeping.
(c) 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 nuclear material.
When applicable, the requirements apply only to the Corporation and personnel carrying out the activities specified in $26.2(a) (i) Lim.@ (5)M375hi$34).
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$2621(EMS)/(2),Nasd (5)tandfacsees16'adltinpartialind sliecius: procedure;foripposiing adplfindingsjef sfTD viciistions Pnensions fdIhIef ths licensee (s) granting Mnescorted 1
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$ 26.3 Definitions.
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Aliiset amanssparborinspecimoniisiidwt6ssingssiliEWiiiiirssHii>is iaiiWissannemis:whosespecknen; ashadoras almenetion essiis"elissnralisiniisupensiisiWeis cisGi'ssist t6sEE6niscts isidli~6thiefsemodhelisisseact decadshon Whafensience,seignsWanpeirmintior:chsniss in 4
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Category lA Material means strategic special nuclear material (SSNM) directly useable in the manufacture of a nuclear explosive device, except if:
(1) The dimensions are large enough (at least 2 meters in one dimension, greater than 1 meter in each of two dimensions, or greater than 25 cm in each of three dimensions) to preclude hiding the item on an individual; (2) The total weight of 5 formula kilograms of SSNM plus its. matrix (at least 50 kilograms) cannot be carried inconspicuously by one person; or (3) The quantity of SSNM (less than 0.05 formula kilogram) in each container requires
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protractea oiversions in order to accumulate 5 formula kilograms.
Comtrission means the Nuclear Regulatory Commission or its duly authorized representatives.
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Con #rmatory test means a second analytical procedure to identify the presence of a specific drug or drug ' metabolite which is indeoendent of the inittel-screening test and which uses a different techmque and chemic.al principle i. rom that of.>*the.w etteFsc.r.w enin,g test..i.n.orde.r to in e
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Cut-offleve/ means the value set for designating a test result as positive.
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Medical Review Of#cer means a licensed physician responsible for receiving iaboratory results generated by an employer's drug testing program who has knowledge of substance abur disorders and has appropriate medical training to interpret and evaluate an individual's positivt test result together with his or her medical history and any other relev_ ant biom_e_dic,al i,n, form,.ation.
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rugs ii6ifdiGg hihsOndicates:thelpeeseneigeonnisulfor'dniginetabolitefa@hst'has; tWiiseensialMeiijonlinned thrggi@hromatogsphihiiisse igniicenznetryJGC&lSitsstirig by an 81HSiessIWed 1sboratoryzesfallSACMG3llSescosityjureatsE Istumatory;conlisned posikve test;tesulti.orJhe. resu.!tio[a.
schuininglistMiliceholindicesing Protected area has the same meaning as in $73.2(g) of this chapter, an area encompassed by physical barriers and to which access is controlled.
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arme at:ha,iongoing responsibilltp for.iliefsuponi ionio(a,nJn,divsdual >.a with;, nescortedlacce,s -
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i status whileM~... n...d. i.sidual:is.i.io.t.h...i...gi.i.s. i. protected,v'idii@.
i Transporter means a general licensee pursuant to 10 CFR 70.20s, who is authorized to j
possess formula quantities of Stiateiid. Spi 6ialN6dsiii;&Asisilil (SSNM) aihefi6sdlirMO CliR
"/3.2 in the regular course of carriage for another or storage incident thereto, and includes the j
driver or operator of any conveyance, and the accompanying guards or escods.
j Vendor means any company or individual, not under contract to a licensee, providing 4
services in protected areas.
t i
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1 B-4 1
4 s
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1
$ 26.4 Interpretations.
i Except as specifically authorized by the Commission in writing, no interpretation of the l
meaning of the regulations in this part by any officer or employee of the Commission other than a i
written interpretation by the General Counsel will be recognized to be binding upon the
)
Commission.
$ 26.6 Exemptions.
The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or p@reperty or the c and security and are otherwise in the public interest. nsqisilist ilsiisiiiiiihldidE5 dei [this'55Et WMWysi@liisisR$5032WTf0MMWIgiscat.Is!
iRMN' essaiitsusir6e.siaiisipsonisa weisiisaicarisisisisiisseassaisarmssitirsassaang diiiniiiilesionii4iiileilspiist mustWiiisdressed to^eielsGItC hh Conhol DeseqMSXNuble.ar Reguladory 8'h=amminainafhsDC205660001aCapies diucomaiunications must isei isiiistelseliquinipriatelegiomd adiosidiiiiisisiiiisiwilinsiscenrh conemunicissionsEsiid japortsfiniiy inehaguered (siersordut Wiii CommissionTcNicalifat2120V81restENW3WashingtonfDCf ofiat l
11tifiSRociadmeTBieMWhlieflinOdorekRodulde,14andand, 9 26.8 information collection requirements: OMB approval.
(a) The Nuclear Regulatory Commission has submitted the information collection j
requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements contained in this part under control number l-3150-0146.
l (b) The approved information collection requirements contained in this part appear in $$
26.20, 26.21, 26.22, 26.23, 26.24, 26.27, 26.29, 26.70, 26.71, 26.73, 26.80 and aAppendix A.
(c) Tra ;c/al burden fer ;taee reeerd;aep;ig rege:reaan;e le ee;;a.e;;d ;e be 010 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> j;
per ;te per yr.;;. ln la.p;einen;;is ita reeerd;,eep;rg requ;reaan;e ;he e' fee;ed l;e.n;;r. ehell reper;;c tra Oerna,;d -n eny ees,aente eeneem,;ig ;te eer~reey ei the ee;;E,e;; end eny suggae;;ene for redee:c4 ;te burden.
GENERAL PERFORMANCE OBJECTIVES
$ 26.10 General performance objectives.
Fitness-for-duty programs must:
l=
(a) Provide reasonable assurance that nuclear power plant personnel, transporter personnel, and personnel of liceneees authorized to possess or use formula quantities of SSNM, L will perform their tasks in a reliable and trustworthy manner and are not under the influence of any substance, legal or illegal, or mentally or physically impaired from r,ny cause, which in any way adversely affects their ability to safely and competently perform their duties; (b) Provide reasonable measures for the earty detection of persons who are not fit to perform activities within the scope of this part; and B-5 i
y,,.
l 4
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(c) Have a goal of achieving a drug-free workplace and a workplece free of the effects cf j
such substances.
i PROGRAM ELEMENTS AND PROCEDURES 1
5 26.20 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 he e.rr.n; jfMwritten policy and procedures as a record until the Commission t.orminates eachMicense5 for which the policy and procedures were developed] and:lif anyportion of the retem-the superseded material 5GiQi jimisine$)or @pojcies and procedures are super minimum, written policies and procedures must address fitness for duty through the following:
a) An overall description of licensee policy on fitness for duty. The policy must address use of l(iidTeb$Nif(lisiliiinisii(fulili)llegal drugs {and-abuse of legal drugsgg cee. L. end en; thema;ei dids, euerssiiiiiifkiii3ssiinfgisiiBesspandjiisisiidi6 -
N iib 5isI@ iiii M K eddjianoise3%rntten Mnthlipolicy 3555snen;s must be Weepsen(iihiOsi[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.-ENNeiiGii[MMyissEiljEEaN pissaigs sil$ss[iiniflsiiliis i
[ff-As a minimum, the written policy must prohibit the consumption of alcohol-(4)[i! Within an abstinence period of at least 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> preceding any scheduled working tour, and (ii!)ll$ During the period of any working tour.
@ Licensee policy should also address other factors that could affect fitness for duty such as mental stress, fatigue l and-illness [5hiiijiijiisi]ii(5iiiidilpn6hTaiEF6ifeiUtliiib6Uhiiiir WWMissidisuesliijfelHisst (b) A description of programs which are available to personnel desiring assistance in dealing with drug, alcohol, or other problems that could adversely affect the performance of activities within the scope of this part.
(c) Procedures to be tstileed iibeiff in testing for drugs and alcohol, including procedures for protecting ;he ein,,;ein E""MajiflissIliin(and the integrity of the specimen, and the quality controls used to ensure the test results are valid and attributable to the correct j
individual.
(d) A description of immediate and follow-on actions which will be taken, and the 1
l procedures to be tetilized ;GEi@, in those cases where einp;eine]siniBiWigli6TafehiIgiiiiiyiipily licenseek, vendors, or contractors]~ahil]iiis assigned to duties within the scope of this part are i
determined to haveE.
N) Bbeen involved in the use, sale, or possession of illegal drugs; er te heve
[2) peonsumed alcohol during the mandatory pre-work abstinence period, while on duty, 1
or to excess pr;.s te p.ERreporting to duty as demonstrated with a test that can be used to determine blood alcohol concentration!
w,_ _iimmeemaioW@lisiiipecimenJo@newaisNMkNk MMhemindRpre (e) A procedure that will ensure that persons called in to perform an unscheduled working 3j' tour are fit to perform the task assigned. As a minimum, this procedure must-i i
4 i
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I
- iiGi8i(1)MWWMMWjiiEdiiMR5is75sidWiif6idisii(MMjhasRequire a statement c
e(
consumed alcohol within the length of time stated in the pre-duty abstinence po (2) If alcohol has been consumed within this period Esiftisjiis5EWhallsd determination of fitness for duty by breath analysis or other meansXcogediori;o[ urine:Liidet j
$21L2#iN3)WMee4Dilred); and (3) Require the establishment of controls and conditions under which a person who has been called-in can perform work, if necessary, although alcohol has been consumed.
Consumption of alcohol during the abstinence period shall not by itself preclude a licensee from using individuals needed to respond to an emergency.
(f) The Ouanweaba.T,.i ;; eny i;,Te rede.; the l,an;n's w i;;en pe::cy end precedures te eeewre ;h.;; hey.T.;;;;he pedeTaenee eyee:L;;; ef ;h;e ped.
(ffi.16isiIsifisisNiiWiIfgishfu~riissiorliil access pursuanfliEl0.lCRt73;56Wpiiinii6isiel 530iii33488ifanneierloomies'sMinogras(MampdlesMW@phedit#st%Ws prograra $wongs vedlication'ilist See individuel ls'cusanth and ascongnus to betsubject to the randoni tesens aistbehaviosai ebservation amera' imsWeltheshisRWemployensrithose 6f:ths 1
hostlicShese; i
i 26.21 Policy communications and awareness training.
(a) Persons assigned to activities within the scope of this part ehe:: fisi(be provided with appropriate training to ensure they understand-(1) Licensee policy and pmcedures, including the methods that will be used to implement the policy; (2) The personal and public health and safety hazards associated with tisiifisis%ilii@al diii@iWiiMabuse of Mdrugs Incisii$g'ead.T,; ease of alcohoi; (3) The effect of prescription and over-the-counter drugs and dietary conditions on job performance and on chemical test results, and the role of the Medical Review Officer, (4) Employee assistance programs provided by the licensee; and (5) What is expected of them and what consequences may result from lack of adherence to the policy, 1
(b) Initial training liiMiiJniiillisiii3?MparagrWihlu)'c(jliilsTas51i6Emust be completed prior teniidife)ssignment to activities within the scope of this part. Refresher training pi[th6ss3ife i6 bio {must be completed on a nominal 4iiHWmonth 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.)
Nisii~addijIW trsisl66Wissisidualsliiilislaavelissii~iidjjesfiii~aisilHsiL~piiitW@r6pasi hind iiiniiiiiiivieteisid inJtselliiii'fedresher training wNhinW241rnordhs before assagnmeint girovided
$lidtsainin$er m$n66iipting Scanseelisiste ste%decific topics covesed typaragraphs*
W@pl ilisecaor9s:compieiedbefas : sis:===isan= nits:dus=Me=acopedthii isarti
$ 26.22 Training of supervisors and escorts.
(a) Managers and supervisors of activities within the scope of this P5 art must be provided appropriate training to ensure they understand-(1) Their role and responsibilities in implementing the program; (2) The roles and responsibilities of others, such as the personnel, medical, and employee assistance program staffs; (3) Techniques for recognizing drugs and indications of the use, sala, or possession of drugs; r
i B-7 l
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(4) Behavioral observation techniques for detecting degradation in performance, impairment, or changes in emplcyceiiirilindiyB6sifbehavior; and (5) Procedures for initiating apprupriate cotre:tive action, to include referral to the employee assistance program.
(b) Persons assigned to escort duties shall be provided appropriate training in techniques for recognizing drugs and indications of the use, sale, or possession of drugs, techniques for recognizing aberrant behavior, and the procedures for reporting problems to supervisory or setudty perrt nnel.
(c) Ir.stial training f6(ssbbrt!ZshdlsUpervis6Fs^ejiipl6ysd)9]icenssss^must be completed prict to bef6Fs} assignment of duties within the scope of this part} and v.ith!r, O months skesptithat after initial superviscri &ssigament/f6Fa5Mikliyee?s'fii5 assig5f5s61565ip55tisbiEduties Widd5ftiWs56pFsf)histisitlthiihitial trainind must bs cof(hplsted as sdon as feasi laterlhan 3 rtonths folidinpLthislitssidhn%nt as appUcebie. initialtrainingfor,sUpefvisdis smployed by -
Frsctors must,lisjs6mpletsd 6efofe'thsiFEssigninsnt to duties witnihlthsts36psLof r
this part or wam 10 daysLafter;theifirst assignment is,orssite s;uperviso!v]dutiss within.the_ scope 6f thislpsrtfwhicheverisitaterdRefresher training must be completed on a nominal 126 month frequency, or more frequently where the need is indicated. Kkrittsii"sisthi6ati6nT6Htissifsihing isatiriaffif5dT66^ih6hiihsl}124ifi6ntliff5&gUsn39'nEP]bEUssd (in lieu of refreshsf trainihg for escortsLand supervisors e.mployed tiy licensees.HThe written examination must require a demoifstrstibn of adequst's kdowisdgeldf thiareas covesd in paragraphT(sfbf thWsestioh.
Reinsshehtrainind f6r esE6rtsi5d supervisors ersploped bilic4n54es must be sompleted on a nomitial 36-monthfraquenby)kehl ekarninatiohs ardsssd to fulfill this rsquirernentjd6 ring the 2
interim pedOd3A record of the training or'sxaminstion in lieu of training must be retained for a period of at least th~ee years.$li656sesfmayl accept tialhingTOfiddidddhisWh6 hs~fslish M
M 26"pf6gFshi[sndlwh6 hayeLhsd thitinRErefreshephainingWithin thsd2 fh6nths bsfordsssignhient/provided that tfalding b/n:is corhpleted before assignmer 1he ?adcspting licsnsse in the;topi6sT66vdrsd by parabrsphida}(n(2)[andIS))f thisl sectio scope;of thislpart, 9 26.23 Contractors t.nd vendors.
(a) A!! contractor and vendor personnel performing activities within the scope of this part for a licensee must be subject to either the licensee's program relating to fitness for duty, or to a l
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 fetained for the life of the contract and will clearty show that-(1) The contractor or vendor is responsible to the licensee for adhering to the licensec's fitness-for-duty policy, or maintaining and adhering to an effective fitness-for-duty programs which meets the standards of this part; and (2) Personnel With a kH6W6filsf6if6@hbstsh6s[dbassidhaving been denied access or removed from activities within the scope of this part at any nuclear power plant for violations of a fitness-for-duty policy will not be assigned to work within the scope of this part without the knowledge and consent of the licensee.
(b) Each licensee subject to this part shall assure that contractors whose own fitness-for-duty programs are relied on by the licensae adhere to an effective program, which meets the requirements of this part, and shall conduct audits pursuant to $26.80 for this purpose.
l I
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5 26.24 Chemical and alcohol testing.
(a) To provide a means to deter and detect substance abuso, the licensee shall implement the following chemical testing programs for persons subfect to this part:
(1) li[Pif6icItsssIResting Ednags.;aridialcoti61]iiiiiisdiIs?siinidsiniiid within 60 days bsfore
. paa to the snettel granting of unescorted access to protected areas or assignment to activities within the scope of this part'shisssRaidiiiiidsil!
MWiisisiAisifissed$slpr6gragr meelHidtliiihiiiiiiiisiheiiriitsRMiispiijitf6Esifisislt30 Biiiipfdrin@isMidijisi:imm6dhiselijwevis(#t6lMarantingWmescorted acxiesRand teWaeidstoevRsubstance *=:
j m%siinsemiinidsii/Widinicohoisiistesiiaissesiiraisiadiisds^WuiiiiiWasiiaissitsdnia siniseow powsmarsnmigdgssonned.consiningier=:unastir.: aces #tsstgM=gativa -
isdvesiidtiitisiat sis %titalisint tidorsaisynnander6imscorted acosss'unless Vid individual tias W6)ilmessyWhensassisis mineliussus:anheihadiliddislbis&iesuR7id M tesfmeetinDM iiisnisamesWidisirGoderami6elihin%iinihsfesomersniing unes&ted accessiWaif bee 6*cossiisdjlliii@pogr55: apaesind gjs]htandardsji(Alis?paitjesiss[conibesutsve weelisWdny 1
1 t..h..a.~t.pa..in_e.. __$_er;) Unennewased drug and alcohol testsygs mus (2)karg in a statistically random and unpred% table manner so that all persons in the population subject to testing have an Ejiiiiiiiiiiihiftiiiip^equa p obability of being selected and tested. Raindorssiihiriy Einiiiirsicisise isistind%urinMlO5Wrijii6dijies(Sas[16cluiW6diisisensiEdi[lischstiiftsjahd i
taolidaysnThe tests must be administered so that a person completing a test is immediate;y eligible for another unannounced test. MM-a minimum, iiIhid6inii tests must be administered on
' a nominal weel,dy frequency and at various times during the day. PEME3W6itifi6iiistlff>s f5E.diiiidisirfgmarss,i,ii.^ymalarenWif.vfr~an~dsiE355ilii@sm.sisiE5"6dflslis. satiesisilsstiiid.16deisting!
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m andnolirelesneal evtAllatile 8or testin0' leta tsnely(genmerfanast b' wetested.at'thelearinist A op$inanitylana iolaious mosaication~s6 sostindividual:sinitimmedist4@
iwisrWiiisidifner:sepsiling forW:sescascii tesesaa his6bia hiripisturnsto-dutijestir@
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signinMUifiguchpers6(asSunOnustLtpi[vaported#91iE}BCMinisitiirn16aC ' Random testing must be conducted at an annual rate equal to at least 50 percent of the workfon::e.
(3)[0 Te.t.4 Efor-cause i.e., e; eeen se psee:Lle Mifar^i6166fi6lN5ti5[hidiUId
~ ~mm MMMN,Ffollowin any observed behavior rplin.,l cond.tionh. d. i.,e. ng thal _creat~es.a.
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' reasonatils~auspecsory possible substance abuse;
[B)Aefter accidents involving a failure in individual performance resulting in personal injury, in a radiation exposure or release of radioactivity in excess of regulatory limits, or ki actual l
or potential substantia 4 degradations of the level of safety of the plant if there is reasonable suspicior, that the wiefe benedu QiGiiiffMcontributed to the event; eHiihil M%efter receiving credible information that an individual is abusing drugs or alcohol.
33is95ilWiddelfshiiisii6HsdilI56sss~sfiiItis"disitliiffsiiiiishilidTsnsifths)idiGiddal is N65 sin @osil11t'faiMpinased isiisiimsinagemord aiiiid"snedical deternanatior6af fitrie 7
i SGodni%ai-MGseyisicoti6t end stie besih sishlysisMegativestneib$isidusi$ " ~
i issEminnattWWWWnsidical determinasionWanessMisibvietsmed@iuthisud165 MiimsarnririalyiisWdisipiMurhaussdrds"aridTalcohol teainghbiNs6 ducted assborfis N@idficablisGnisiliiiilisdFliirniince^diWiiisedl$ Except Under'do^ umenteid 'snusual birie i
c JWisa%.susiiiitMcsaiuctedwHits$^^ ~moreittieriThiopisWiisisicoholM5hd8ti$Ursf6 jf i
minuaihotiiwMudhisXesti
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(4) Follow-up testing joiuid.;tsisusdsiliid]on an unannounced sisiiIaijiifsdistable! basis to
- ven'fy continuud abstontion from the use of substances iiii' covered under this part.Sdi6diGiddal Nf35AIA$Eil@$IiIIEEMl[Wj6EjMiill6ishMU@ifi3Mdsi1T@dishiisiO@itjndtMs B-9 l
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.O frsqUshilp?thsiil656iisisip)dldspsf6Ff60&65hths3ftsfl66sscortsd?sc6sisislisinstatsd arid at less(6hes'eVerp
$26;. Tlifunescal90 dsps forthe next fiusysariandlighfisoht dsdaccessMahreinslateld fodthat i'.diiddaljaftsri'suspshii66 bHUd 27.(b)(3)3of (ii) Unes56fiedV66EssWilllEs isIEsisisd forMiddMddsfsfisffesi6ValifddsfLS26.27(b)
(3)3_ b)'{4)fbr!(cJ'i (5) Returift6%dtitis~tihiidd51 Es"66hdu^clid%nih~s*Esrs66sssksii6^fsdairibbescorted 566esstorpr6tseted areasiof the site kihuesti6n afteran a6ssnde from the possibilitp of being issted Under thst' site licensse's pitigfam for mofe t6sh 60 days br%sn a psrsod seeks to rehain16hesc6risd HE6ess after having besh dehici. 46eess und6f.thspr6Visi6hf6f $26:27(b)2 Anp nedstise deugihd alcohol test meeting tii6 standards 6%this'paitland performed %ithin.60' daysfbefope the grsf4ing bffunes56rtsdlaccessinayLsshe :as thnsturh-t6-dutp test excspi in the cass of_th6hsMo have beshldenisd sceass Under the' provisions of $2627(b)XA negatius' test resull'must bsLobtained befofe thebranting ;of snesc6rted secess"Unless the individual has"ho histor)s?of 50bstancs" abuse and'eithef tias hedInegative test resulfsndiest mseting the '
starid rds bf this"pait performed withirs;six rhonths befoie theieldstatementhf usescorted secess(6r has bee 6 covsfed bp ajrogram3sheetihdthelstandaFds of this part forltwo 66nssdutifs iveek'slinrihg;that period; (b) Testing for drugs and alcohol, at a minimum, must conform to the " Guidelines for Drug and Alcohol Testing Programs," issued by the Nuc;sar I;egulstcry Octnin:ss;cn NRC;and appearing in aAppendix A to this part, hereinafter referred to as the NRC Guidelines. Licensees, at their discretion, may implement programs with more stringent standards (e.g., lower cutkoff levels, broader panel of drugs). All requirements in this part still apply to persons who fail a more stringent standard, but do not test positive under the NRC Guidelines. Management actions must be the same with the more stringent standards as if the individual had failed the NRC standards.
(c) Licensees shall test spidthshs;E6ils6tsd;UddsisicS' tips 6ft ssi listsdlih"S26.24(a) for t
all substances described in [psregisph 2.1(a) of the NRC Guidelines:(AppendiQto'partl26). 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, other substances so identified may be added to the pane! of substances for testing. Appropriate cutt off limits must be established by the licensee for these substances.
(d)(1) Alf'6611ssisdudhsjhi!6!66djspsbiihsiisihUst 65]diwardsdi5^sT15ti6rstojfesrtified tip HHS') except that11icensees may conduct initial screening tests of bhne an-aliquots to determinsjwhich speclids6s[ sis $hegsdyEI6d hidd;~56Tf6tifieftssting} beicre forwerd ng 3; ccted spec;rnens tc s ;&bersicry ceruf;ed by ths Departinent cf !!ealth and !!vinan Oervices (!!!;Sh 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. AlfE6Etitsstihidispecifns5sih6st'indlUdstsstsid"snsBfispsahis6'vs.lidity[ss fscl Ilsdby125) ofAppendiRA to Mart 263 Quality control procedures for initiaFscreening U
tests by a licensee's testing facility must include the processing of blind performance test specimens and the submission to the HHS-certified laboratory of a sampli,ng of specimens initially shaliied teste+as negatWe, Except for the purposes discussedjr[S26.24(d)(2)-below, access to the results of prei;rn;nery thsfa660ss6fssnisp; tests must be limited to the licensee's testing staff, the Medical Review Officer (MRO), the Fitness-for-Duty Program Manager, and the employee assistance program staff, when appropriate.
(2) Ne-Ari; individual may iiot be removed or temporarily suspended from unescorted access or be subjected to other administrative action based solely on an unconf.rrned pissbihpiiiTipositive E6tsshihitssfresult from any drug test, other than for marijuana fEHG) or cocaine rnstati6liiss, unless other evidenceTisclUdi6finfoisisii6ffo6fains(LHdsr'ihsipro6ess? set B-10
.o faitfGr(Ss6tidr[2Me[6f appshd6M indicates that the individual is impaired or might otherwise pose a safety hazard. With respect to on-stte WitsinttreFscreening tests for marijuana (THG) and cocaine [5etsb6l des, licensee management may be informed and licensees may temporarily suspend individuals from unescorted access or from normal duties or take lesser administrative actions against the individual based on an uncer.T.cmed presumptive positive scr6ehihy;tssi 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 specimens which were determined to be presumptively positive as a result of pre:im:nsry on-site 5nsits screening tests during the lastO2-month data reporting period submitted to the Commission under S26.71(d) were subsequently reported as positive by the HHS-certified laboratory as the result of a GC/MS confirmatory test.
(ii) There is no loss of compensation or benefits to the tested person during the period of temporary administrative action.
(iii) Immediately upon receipt of a negative report from the HHS-certified laboratory, any matter which could link the individual to a temporary suspension is eliminated from the tested individual's personnel record or other records.
(iv) No disclosure of the temporary removal or suspension of, or other administrative action against, an individual whose test is not subsequently confirmed as posittve-aivibisti6nlof FFD policyyy the MRO may be made in response to a suitable inquiry conducted under the provisions of $26.27(a), a background investigation conducted under the provisions of $73.56, or to any other inquiry or investigation. For the purpose of assuring that no records have been retained, access to the system of files and records must be provided to licensee personnel conducting appeal reviews, inquiries into an allegation, or audits under the provisions of $26.80, or to an NRC inspector or other Federal officials. The tested individual must be provided a statement that the records spicifisdjin paragraph (d)(2)(iii) of this section have not been retained and must be informed in writing that the temporary removal or suspension or other administrative action that was taken will not be disclosed; and need not be disclosed by the individual;in response to requests for information conceming removals, suspensions, administrative actions or histor of substance abuse.
6ofisatio(y)Ine~ peri 6d ef'tir6FalloWid tistss&Et6F66tifcitiad^of ins e
n of a specimen m6st be kept'at 'a miriimum'corisistent withlop~erationai6onstraints; Whsnevet practicable? thslindividdial should hot beLalloWed the time brbpp6rtunity to' obtaih
~
insterisislottake"an9;a6tiori that woluid sabpert ' he:tssting.pr6 cess or' the test rssults t
results[s(ep6ile3 bitheTiHS$iitifi6d isti6fai6iy[airi3]i6tifyf6ensee m;anagemeht-mtr comp lcted and ;icensee-management nour,ed v.ithin 10 days of the inid&l presumptive positrie screening test ss"566Essfractisabis3TnEMRCfshallisp6ftstildsisiininatidhs bf%iotali6nsjof
^
ths reehses's FFD policy 16mariadsment in Writinh and inia ruannerldssigned 1o ensure bohfidehtiality'of the inform $ tion /To assure'that action is taken irnmediatelyl provisions ~BiEsi be
~
rnade 16' ensure thst the'MROfis able 16 c6ntact appropriate licenses managstr$ent at any time.
Sh6uldlthe MRO's review not be completed Within14 daps'bf:the"c611ection of a' specimen; licensee madsheinent mdst be advised of available; test results/the;statusl6f the revieRths
{essonsiforithe delay /and appropfiatefscornmeindatiorjs1 (fg) All testing of urine; specimens for unne-drugs-testtng, except on-site testing screening tssis[peifoW6fd;bijicassees;under paragraph (d)-above'6;f this ss~ctidh, must be performed in a z
laboratory certified by the U.C. Dep&rtment of llca:th end llumen Oervrees HHS for that purpose consistent with its standards and procedures for certification. Except for suspect specimens submitted for special processing (Oectica $ 2.7(d) 6f]sfof a4ppendix A*(6~pait 26), all specimens sent to fli-!Sicertified laboratories shalFinust be subject to inttreFscreening analysis'by the laboratory and all specimens screened as presumptively positive shalHudst be subject to B-11
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_._ -pm mmw vm.s..
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- ses, z
l laboratory. Licensees shall submit blind performance test specimens to HHS-certified labora*.ories in accordance with the NRC Guidelines (aKppendix A)$136sneesi~E~ iEiifsi~disEat IN EdBuiniif'sissiliiiiiiisifi~155lidiiiiii)iit laliiiiii6iiiis sejinfrHsiillsMall..ispecimens'sesit foi '
~
neelingdaciudillig Illind.performanciltestispecimens, 4
(gh) Tests for alcohol must be administered by breath analysis using breath alcohol I
ene:ine C7 devices meeting evidential standards described in seetten aAppendix A$tsjiiiiik^28. RiniiisinisisliigTiiiiLidissiiss;tdoid~dl6chofs6ssiiin$ 2.7(p)(O)(3) alish'(84C)WA02 fiiu66ii0iif^ iesteF?e cuilinnmangtset foialcohol must;lii[periositted using ano#Far,twssth g
alcohol ans@pis deMA conBunatoryllsis@iibbreath alcohol content indicating a bleed eleche:
eeneentrattenilACof 0.04 perceM or greater must be iissiiisifa positive testfesult. X 656EiisisiffiistfaAiiifahoe4Ri*aIBA6dNW5EiiiiiiUifgressifiifliftlii'individUilhiisThesitin i
slsnuscassius sittino 42Woom hoursteirasac^otam pesenne siipeacefaaer ss individuai hsilbeenliq5jiuost(stelusjohnoseWiarioninMMuusysissliibMeclasedMp6hilivaiMfoi j
alcohol.-The ee.J.a. ;eri eet fer ;;c~he et.;;: be cae c. ene:her bra:h ras..ieri.en:
- ne:reiner.t. OhaM :he F.reen Cinead fui:h.i c~ii.e.._;;ea, th;IFGittiiFisitisi^siiFiilisii61]iiiidst kii'9aisuiliisiiiljili~oif bl66iii.sjisilisisisiifsiidiiiiUis?siiijWaidministand W hequested tp the individualMthelpurposesu obtainisig5dsShonal. infonmatiorittisitlicouldbe2 considered;duddah apposipursuant tsj262S? Suctim test must be a gas chromatography analysis of iimhole blood i
l perfdanedishitalciodspecimen drasiiifsifisiiiWiiFpsibRde"5hii%MMP-Vtifeath I
analysis.7Ardalochol in phiitlood specanecidiaphefoonsidered togethetstith the elspsed.ltiine hetweenwchnannatorfisksnd spa-% wthstsood specirnen d
Mmedicalcondi6en'Siid O MNM sisilialisens duBouefor hazandousstliiindRoliiihonsudtseiosUiidginitreatingWpe@rso physicia:Raiisyinushorbsierfadtimadvs evaluaSon processiteRoced ti thsindarlduali:sislfsi determininifishedhe@violseon}bt,Siness includes measures to pavent subversson:4cedutypoBohiinsfoocungdpprovided Siii#6 ce]
l and can acitieueresults comparadble,to those produced l
t$urinalysisMpegal drugsand breatig analysisitoissicohol l
l 5 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, short-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 should iiiisistjbe designed to achieve earty intervention 57#iiiEADisasfais6 and provide for confidential l
assistance!audsidj#iiib-Tihe 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).
$ 26.27 Management actions and sanctions to be imposed.
disdigis(a)(n) ll)^9666iE'aisilisi6g~af(iridivil$Giljd"ictiintimi5iiiittiidyiii"s~iipii'6f thiijiiirt2as 1
whether luie52s3(si)2Tthe licensee shall obtain a written statement fro ill
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of this section is established 3iiMciffailiss~a'66isuisisfiiUftliijiiiiihitiiiiiiiMa#3(2)75Bdl3) fusi, the new lcohol.cdiru assignment to activities within the scope of this part or granting of unescorted access must be based upon a management and medical determination of fitness for duty and the establishment of an appropriate follow-up testing program,@isiiiiiilliiidMja63!MiR4): p3eTided Tihe restrictions of paragraph (b) of this section areinestWobservedithesefnistiilctiinsEstuds NFS^-liiiiii3Isii@ii6Ethihi(916EiisfandproWKaitiilinence To meet thethe[suitab.le ingidly requirement, the identity of persons denied unescorted access or removed under the provisions of this part and the circumstances for the denial or removal, including test results, will be made available in response to a licensee's, contractor's! or vendor's inquiry supported by a l
l ey,.ed.elease fremisi@6iiiilWthe individual;iislii'16ssiligsisisilfiisidtlistliisltiiie;disdiisurfof ihs.lJilsshief6iQ
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8)WsisiilisilEElinaisiaissfiisisisIailfliississiiiussirss~iil66stiiiig'stidisissSFFDissii69; iisiac_ensee amst enhor compifaisi tisjnequimenenhilormisisectionWfue unescorted sc6ess 6f:coinplate#sullable iisist ryWiillithsisocunecif6f tesiiindividuarswntsen statement"obtsidsd i
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'administsefiillfighsd' alcohol tist irifacconlandsudBq;1hiiIequirementfof( 26;24(s)(1Rirj maleneW'siilistse inquirycovedne teniliiist year ssi:livitiestesiiseenseeininfuiietinfdihati6H a
reBeivedbaiEsiiitelephone:#Tsseconshihiiloontents'st ssif feisphone' sat isfrnaderind retainedfesistonneson received tipalemensic mennisastiassassimnelis4mait ~
WytWindividuallmsiii m__mporarracoessprovisionsielesiin'sweviously> moved fonimianrid a sconsie'iFFD?
p :sfis)ussidumsis(6stumi;cFn7:36 arainct siippacatniand sannot tieIuazed:
rso taisEiilism)ier;stiirsiesseinesers pe@eram f6:!ansesWooilaisinesscensee suitable'ingjiAriMiisirf90si72 hours 2alteir9unes6erted mo6iss;lasheen testored 16%i65itaihlf thessisiisiiFiiiy?oubstisce abuse diether^ vioisuoriisi FFD)oBcy,during tii?absenoe/ahd 'rnust '
assureitiidlWaslsequirementifsfiteelingiriacconsonoisilh$nsceiv(edceofthiM 2624 a)(5)"tinGuilboenfistisfied; in maldne sie suitable inquiry!thsJioensee:hnifEiie:Wonnasi6r incord of)hsiconients sf tiniitelephoneisalliis^madelisid;fiistairie'$2Rinformati6tGsseiseditsy electrahicpiaMindisclUite[deceimilejiiSNnell..
(b) Each licensee su 'e_ct to_this part_sh_all, iifas-a m_in.im, um, take the following actions.
Ne h nii h...., ehe;; Dne--
_ jddsper_aGrapl@.po(prohibit the licensee from taking n-more stringent action.
(1) P55Eci65sl Miihiddi5iliplidinisTidi63iii]iimpairedNe,Lere, er those whose fitness i
may be questionable, inhd 1 hose <lstermined 16haveinssiiiid tiiiiili6idise's fitne5A6EaUffpoiscy shall be irshiiiiiiliatelfidenied, unescorted apoess[dothensise$ removed from activdies within the scope of this part;-end.'Tliisiipersoirts' may be inseignedijiiiiFretumed l6)isi[dstisiIonly after Iliikilifrisjidessin6ssible..conditionsWrssotsiQndhindividifal]iiIdetermined to,be fit _to e
~
safely and competentlyperform activities with. the scope of this partbyan ap ropnesn.e manager in p
Eiifa,Edisisifii6jilsianlis90iididiiiifiiEtliiiIlsisiN6iii detisilsiilliiitMillness# Whit 6rN!Y:lutp test?under$26.24(a)(5)'must biibonducted beleireWindividuatiiispltieIretumed scidUly;stid,i abstinience(fromittle[QUginesting undefi26.24(s)(4);mustWsdridui:ledKverify contins whenapplicalAe!5 useMaubstancesl (2) Lacking any other evidence to indicate the use, sale, or possession of illegal drugs br M6fjiill666ibslon site, e cent,nied peas se ;ee; i;;dt "~ssiltisisigimust be presumed to be an indication of off-stte effsils drug 6EmiEotiofuse-liiivihlation~bf tinifcisiiiiiis ~FF olicii
_M%66Hil6'ry connihied positivejsMTes0ltMNordioIdhMIBO a violatio.n:et (iTF5ihMi?2.E/hiriiitiliitWsl56fi60fiiiifisidl6slissfilsindisiddid.liinifs*BAC[tfial Yi61sIsd $10Estandards established iri$2624(h)O' -[of theRDlpo5cyjiMrd
- 3) The first eenT, riced ie;n,i: ;ce; # lduring~shfscheduled woddngli60iFJ Jiisliiss[7dsisiditisninallisii{must, as-infa minimum, result in immediate remove! from ac i
within the scope of this part for at least 14 days and referral to the EAP for assessment and counseling during any suspension period. Plans for treatment, follow-up, and future employment; ifilipplisibisiij must be developed, and any rehabilitation program deemed appropriate must be iriitiateId during such suspension period. Aidisiiijfisii^iiiulisidssis6isitisiihihisisilid'fr6Tifsstisities
^
66YiWilliRthisiTiiiInt71f thsisidiWoGifliii~riiddined tiipsaillconseeVsriisiNployrvienfitatUsjehdins isirvitatsmentwsnsscorted accessitins:individdet must continue titis^cosere@uring sny B-14
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(45) Persons removed for periods of three years or more under the provisions of Paragraphs (b)(2)-end@f(3)@) M)Eiisil}c) of this section 'er ;be. :c,e; ee:e, see, er i,e.eeee;en of dn.;ge and who would have been removed under the current standards of a hiring licensee, may be granted unescorted access and assigned duties within the scope of this part by a licensee subject to this part only when the hiring licensee receives satisfactory medical assurance that the person has abstained from tiiejiisMdrugslfor at least three years.
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Any eenT.....d use of drag;;hi egh th;; preceae er eny e;her de;;;rn; net;en of euteequen; nve: veiner.; ln ;' e d, see er peace;;;en ef :::ege; sube:ensee idreisr biolati6riIbf FED'ii61 cy must lisiissisiiilTy result in permanent denteGiiFodiiii6iWaiGio0zationMerfMr[ictistiss difcitedin$28.2(ij ef uneeser;ed eu ee.
(SWB) Paragraphs (b) (3), and-(4)7aihd}5) of this section do not apply to[t6ehiississl6f alcohol, valid prescriptions, or over-the-counter drugs. Lcensee sanctions for confirmed misuse of alcohol, valid prescriptions, and over-the-counter drugs inGifshelFbe sufficient to deter abuse l
of legally obtainable substances a substitute for abuse of proscribed drugs.
r,6 i, S,M.)3epse':e res;de ; e-- ~...en fer ;ee;.. end XiipliECs Jc wm,ilshiid.isissil.gi s,.
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desa' dbedRgas.agaminhnitivearsd3huicW.nenwiedi,act#iutiserWisitidd process 26f resignation listois/pr;a ;e removal for violation of company fitness-for-duty policy conceming drugs EHa'incohotjmust be recorded 3ihispi6iiiiledjiisisisiipo65eli6Tifjiuitablei'hiq'Oi/p-es mneve:e fer eeuse. Itis?ssiocilii6iiGiiV6IfiTEnovat.%Minisiliitaboratosconfirmediositipe W5iiislI~esis~51iiiilsed5 rid #sitMirullwiduaisesigned beforfenIRO isvisw2must also)e i
provided iriirasponseitiiVsisitableisilbiryffhes & records $Uhese actiorisimust be retained consistentisfitti$26J1(dffer:h~e gee of,s;.ng :he requ;rernente of $20.27(e) foli i
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revocalsoriMMsthibiisalid5V jdliillisisTaiIsdrtisahj26 Mis (d) If a licensee has a reasonable belief that an NRC employee jiD_ IRC_ con _ tractor)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 i
Regional Administrator must be notified immediately by telephone. During other than aormal l
working hours, the NRC Operations Center must be notified.
l
$ 26.28 Appeals.
Each licensee subject to this part, and each contractor or vendor implementing a fitness-l for-duty program under the provisions of $26.23, shall establish a p?ocedure for licensee and contractor or vendor employees ifrid'Ajii@lici6isl6sijiiiE6Hsiil'siciisito appeal a pee;;,ve i
eleche: er dreg determinationiliinsolation16fITDholicy "The procedure must provide notice to KiiidisldGilloffui[560silif6Ohe?detemnina8cnfeffwi61ailissWFFDissliby7and isiseGiifsWee an opportunity to respond'irif toisubmit addstionalcelevant informationfTlievi6Eidure r6sst l
p"ilfiiidilsiii*arfebjeclWi$iinpertisliiiimediis thijitects relatindtoftnisiotermestionlofyvionshon[6f FFD?podcydIThs)evisninusiniEconducted tip persims6t associated sith 9ss! administration :of liienhls M W$25.2(a)(4); and may he en ; raper;e: #2sade~intemal management-fewsw K#tsfappeelgsucbei,sful[yiiiIisii~v551jicordslmust_ tid 66ihiscisd$A licensee review procedure need not be provided to employees of contractors or vendors when the contractor or vendor is administering his-itsJown alcohol and drug testing.
$ 26.29 Protection ofinformation.
(a) Each licensee subject to this part, wheMcollects personal information on an individual for the purpose of complying with this part, shall establish and maintain a system of files and procedures for the protection of the personalinformation. This system must be maintained until the Commission terminates each license for which the system was developed.
l B-16
.. _ _.. _. _ _ _ _.. _ _ _. _ _ _. ~. _ _ _ _ _ _ _ _. _. _ _ _ _ _ _ _ _ _ _
F (b) Licensees, contractors, and vendors shelfisiiEnot disclose the personal information collected and maintained to persons other than assigned Medical Review Officers, other licensees @iEliFAiFrM$siasWrii*, 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 employees or contractor personnel, NRC representatives, appropriate law unforcemer.t officials 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 liiiidisiifdiisshisiill66sliiflisisisiIshdl audits of licensee's, contractor s, and vendor's programs,16 tui 6f sidiUHiiSIF5iiiiisiN53nllisEdWS%iJtisfl(W) residing ogiogr#Afrheint:
ito persons deciding matters on review or appeal, and to other persons pursuant to court order. This section does not authorize the licensee, contractor, or vendor to withhold evidence of criminal conduct from law enforcement officials.
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request.
INSPECTIONS. RECORDS, AND REPORTS i 26.70 Inspections.
(a) Each licensee subject tr, this part iijBjlsiiGi65iiiiiiiis3iiidlyiijadhi shall permit duly authorized representatives of the Commission to inspect, copy, or take away copies of its records and inspect its premises, activities, and personnel as may be necessary to accomplish the purposes of this part.
(b) Written agreements between licensees and their contractors and vendors must clearly show that the-(1) Ucensee is responsible to the Commission for maintaining an effective fitness-for-duty program in accordance with this part; and (2) Duly authorized representatives of the Commission may inspect, copy, or take away copies of any licensee, contractor, or vendor's documents, records, and reports related to f
implementation of the licensee:s, contractor's, or vendords fitness-for-duty program under the E6ntisiliiigf7MMHS@llertilledlaboratorpftlRO?EANiipd)pecimen collectionsio^
scope of the contracted activities.
services) vessandNii6inseetcontractoi2EvendoMisosiams.
5 26.71 Recordkeeping requirements.
4 i
Each licensee subject to this part and each contractor and vendor implementing a j
licensee approved program under the provisions of $26.23 shall--
j (a) Retain records of inquiries conducted in accordance with $26.27(a), that result in the granting of unescorted access to protected areas, until five years following termination of such 3
access authorizations; (b) Retain records -,,~,......,_
j C;v:,..c 0%.i, $$QiMiliniiisiiniHEIn]ili[eMMEFDijiisisiEand the related c
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l personnel actions for a geriod of at least five years EMiniIgiliti66KilGijiGii66siiiiiihsi iiiiiiiENtiiiGi16tiill5itwhicheverh ister-(c) Retain} records liedainkdMJiliHiilissiliibWwl6liiiiiEMMfYp~pcilidEqf persons raade.d.,Te fer ;hra yeece er leagei fer es;gan en; te y,Wauthorizatiorito jiiiftish7 activities within the scope of this part liiiiliishh*assliiidjunder the pres e;eae of
$26.27(b) (lit,-(3), (4)RS) or (c), until the Commission terminates each license under which the records were created; and (d) Collect and compile fitness-for-duty program performance data on a standard form and submit thes$iiii[ data to the Commission ibliiiWRfififN"gideliiid$assiiiijn 86IUO5k iiiid@lf~
W[Jubihiidil%BH6dgh Debeihbih 1%riojaterApanMj%says$E5Ikihjid6)#heepor]tingpasiocigssh;a = deye e
_a ma m enis.
Linea'J. reper;;as per;ed (Jeaueri-June end July Oea,aher). The data for each site (corporate and other support staff locations may be separately consolidated) must include: random testing l
rate; drugs tested for and cut-off levels, including results of tests using lower cut-off levels and tests for other drugs; workforce populations tested; numbers of tests and results by population, and type of test (i.e., pre-access, random, for-cause, etc.); substances identified; summary of i
management actions;iiiUNilisiiFiliPS -"milisSili3iijissfand a list of events reported. The data must be ar: 'nnd and appropriate actions taken to correct program weaknesses. The data l
and analysis must be retained for three years. Any licensee choosing to temporarily suspend l
individuals under the provisions of $26.24(d) must shin report test results by process stage (i.e.,
on-stte 6Eiiles, screening, laboratory screening, confirmatory tests, and MRO determinations) and i
the number of ternporary suspensions or other administrative actions taken against individuals based on on-site ediliis uneen',.Tued eereer.;as pe;;;.ees g'isiisGHiigitiWiisiltlie 56Hiiehidiisii l
Hisni@or marijuana (THC) and for cocaine.
$ 26.73 Reporting requirements.
(a) Each licensee subject to this part shall inform the Commission of significant fitness-6(il66h(i. Sale, d,cludingM,iisf 560ihiliiid)6:
for-duty events in g-1) streutionhuse, orpossessionectpresence of illegal drugs o-_tuse or presence r
ljwithin the protected area-end, (2) Any acts by any person licensed under 10 CFR part 55 to operate a power reactor; er by an
. (f@y supervisoqpersonnel assigned to perform duties within the scope of this part}gtiplan rggram;M4ms;speclReMS2SM5Me-(i) Involving the sale, use, or possession of a controlled substance,
$idisid0(iljisM6istidMli65hise$fEOjistidy,ii) Resulting in een'.aned ---;;;se ee;e en eu (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.
liRilisiiife[diits esiiiEsist)soubi.6EWhonestWiiMinsEritiMiniRD 37Arifiddi'niifiiidUld?ssifici60t(6iilesiiTQ~6f hiiEFFD?g'ini r6ghiini:puisonnet spiisalaiiM5282(aX42 (4NNtestMXW6isiiffsiTsiils7diittfbstidhI, OIREIMMMlijalfd6@[dW6ff i_llii?
I (b) Notifications must be made to the NRC Operations Center by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the discovery of the evetit by the licensee.
(c) Fitness-for-duty events shall be reported under this section rather than reported under the provisions of $73.71.
B-18 l
l
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(d) By November 30,1993l each licensee whoeiii[is authorized to possess, use, or transport formula quantities of SSNM shall certify to the NRC that it has implemented a fitness-for-duty program that meets the requirements of 10 CFR part 26. The certification shall describe any licensee cut-off levels more stringent than those imposed by this part.
AUDrrs i 26.80 Audits.
(a) Each licensee subject to this part shall ~compEsiliaudit the fitness-for-duty program nea..ne: j e.eri 12 a,en;l.isifissiisifffsid5iiiilsis^tequenditherfewer/Friissilii$lisiisisis iiis
^
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W iiFINipciedeselL c- =yomososiss>W<sernewlpipeidoisismeSitisArigd/siiiif3eseosiiilspined$hsisooniss assisinw merwgniscahemenosumreenwo passannat proosiluresfhrsspiipment!ScenseesisiisdseeR Wliejuisrtidader' program element a
anacsossiy9sitishiings%essurs sin 9ndd guggnmielfacGuiinassiftogram elementsMidi meet conenisisestiiiimudiend naminssyeveryM2:monihsincluderrfojwegam eleinents implementedligioonkscears:sindiendors under%iii paisisionf4326:23ttestsiiiiiiifoWhid"it HHS certBied idierededesfind FFDisesvices provided tiiWie'9comiseWpersonnointibiarebff smiikksande[Milirect)MiyMpervisionMobeeristiiriWucensee" personnel l?,.55,
sed;;e raue; be eend e;ed, nea.ne;;f sweri 12 a.er.;he, ef these per.;ene of f;;ncee-fer-d ty pre,ea.e ;av;eaan;ed by a,n.e:ere er.d vendue. Licensees may accept audits of contractors v
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 of the audit report, to
- nclude findings, recommendations} and corrective actions. Licensees retain responsibility for the effectiveness of contractor and verdor programs and the implementation of appropriate corrective action.
(b) Audits must focus on the effectiveness of the program and be conducted by individuals qualified in the subject (s) being audited, and independent of both fitness-for-duty program management and personnel directly responsible forimplementation of the fitness-for-duty program.
(c) The result of the audit, along with recommendations, if any, must be documented and reported to senior corporate and site management. $hTeaGillfiisp"ioijsisfitishGff6iiriditi66s si$0iissliiBiiiijiiiiijisfiisid55nsoce;ipOliiIITDTprogras@Siisisusehfthiils6ndition(s)'andEsirWen hpeopnesel=ossnesadoossesveerons aseengementisesissiinies/mismaditansirigi:1sha
'taile)DE0mMya0liosh Ingdiading se4ise(5(MdeAciset amesMista MMjmecdudef$tijih
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reasog pspelNiorte[Sti@xantilldgj The resolution of the audit findings and corrective actions must be documented. These documents must be retained for three yearsMO Oe:de;; nee requ;re hensee-eudits of ;ll:Ocer.F;;d !abere:er;e; ;; deea; Led ln apper.dk A.
ENFORCEMENT
$ 26.90 Violations.
(a) An injunction or other court order may be obtained to prohibit a violation of any provision of-(1) The Atomic Energy Act of 1954, as amended; (2) Title 11 of the Energy Rectginization Act of 1974; or B-19
\\
(3) Any regulation or order issued under these Acts.
(b) A court order may be obtained for the payment of a civil penalty imposed eder i
section 234 of the Atomic Energy Act of 1954, for violations of-(1) Section 53,57,62,63,81,82,101,103,104,107, or 109 of the Act; (2) Section 206 of the Energy Reorgrmization Act of 1974; (3) Any rule, regulation, or order icsued under these Sections; (4) Any term, conditica, or lirnitation of any license issued under these Sections; or (5) Any provisions for which a license may be revoked under section 186 of the Atomic Energy Act of 1954.
]
$ 26.91 Criminal penalties.
l (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued *.mder sections 161b,1611, or 161o of the Act. For purposes of section 223, all the regulations in part 26 are issued under one or more of sections 161b,161i, or 161o, except for
. the sections listed in paragraph (b) of this section.
(b) The regulations in pcrt 26 that are not issued under sections 161b,161i, or 161o for, the purposes of section 223 are as follows: $$26.1, 26.2, 26.3, 26.4, 26.6, 26.7, 26.8, 26.90, and 26.91.
1 l
1 B-20 i
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APPENDDr A TO PART 26-GUIDELINES FOR DRUG AND ALCOHOL TESTING PROGRAMS Subpart A-General 1.1 Applicability 1.2 Definitions IX$NEEUMl355 Subpart B-Scienti6c and Technical Requirements 2.1 The Substances 2.2 General Administration of Testing 2.3 Preventing Subversion of Ter 2.4 Specimen Collection Procec' 2.5 HHS-Certified Laboratory P'
.annel 2.6 Licensee Testing Facility Personnel 2.7 Laboratory and Testing Facility Analysis Procedures 2.8 Quality Assurance and Onality Control 2.9 Reporting and Review of hesults Subpart C-Employee Protection 3.1 Protection of Employee Records
3.2 ladMdue
As-se;;; Tee; end Lebere;eri Cer;;f;e ;L.."eeu.".e Subpart D-Certi6 cation of Laboratories Engagedin Chemical Testing 4.1 Use of OHHS-Certified Laboratories B-21
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Subpert A-General 1.1. Applicability.
(4)@ These guidelines apply to licensees authorized to operate nuclear power reactors
. and licensees whe@(are authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM).
(9)(4 Licensees may set more stringent cut-off levels than specified herein or test for substances other than specified herein and shall inform the Commission of such %s deviation within 60 days ofimplementing such change. Licensees may not deviate from the odsiir provisions of these guidelines without the written approval of the Commission.
(S)hl Only laboratories which are HHS-certified are authorized to perform urine drug testing for NRC licensees, vendors, and licensee contractors.
1.2 Definitions.
Is ;te purp.ees of h e ped, @iiidRhisijijiWileniilbiifc~siWBiiilKg2Mthe following definitions apply:
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" Chain of custody." Procedures to account for the integrity of each specimen by tracking its handling and storage from the point of specimen collection to final disposition of the specimen.
" Collection site " A place desi0nated by the licensee where individuals present -
themselves for the purpose of providing a specimen of their urine, breath, and/or blood to be analyzed for the presence of drugs or alcohol.
" Collection site person." A person who instructs and assists individuals at a collection site and who receives and makes an initial examination of the specimen (s) provided by those -
individuals. A collection site person shall have successfully completed training to carry out this function or shall be a licensed medical professional or technician who is provided -
instructions for collection under this part and certifies completion as required herein In any case where: (e) a collection is observed or (b) collection is monitored by nonmedical personnel, the collection site person must be a person of the same gender as the donor.
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i Subpart B-Scientific and Technical Requirements 4
2.1 The Substances.
a l
(a) Licensees shall, as-ii(a minimum, test for marijuana, cocaine, opiates, amphetamines mww, phencyclidine, and alcohol for pre-access, for-cause, random, and-follow-upsshy a
i.mm...._. - tests.
b) 1.Jc_ense_es m_ay test fo_r a_ny illegal drugs _ran_yi. sisf~~s~b_siiHBis_usp_ect_ed_of h_a,ving o
s s
be_.en _
_1andmay,co_nsiderany.d_tect_edd osa_rm.ah.
whend. terminingappropriate i
4 e
m e
actiosiduring a for-cause test, alreldrmtcM$utitestidtidemoval 46 iiiscces{uridetg26M(@
d i
MihisiiWiiiU5iliMustWisMfo80*upJostine prograri, or analysis of any specimen 4
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Isihp_ected of being adulterated or diluted (Eisu6]dMiillii6Fsstistilstsd[threggh hydre;;en o susp l
adi(iiM5anypther means.
(c) Licensees shall establish rigorous testing procedures that are consistent with the intent of these guidelines for any other drugs not specified in these guidelines for which testing is authorized under 10 CFR Piiiif26, so that the appropriateness of the use of these substances can be evaluated by the Medical Review Officer to ensure that indiviiuals granted unescorted access are fit for maintaining access to and for performing duties in protected areas.
(d) Specimens collected under NRC regulations requiring compliance with this part may 3
i only be designated or approved for testing as described in this part and shall not be used to 4
conduct any other analysis or test without the permission of the tested individual.
(e) This section does not prohibit procedures reasonably incident to analysis of a specimen for controlled substances (e.g., determination of pH onRiests for specific gravity, l
creatinine concentration, or presence of adulterants).
I i
j 2.2 General Administration of Testing.
The licensee testing facilities and HHS-certified laboratories described iri this part shall i
develop and maintain clear and well-documented procedures for collection, shipment, and
)
accession of urine and blood specimens under this part. Such Tliiss procedures shelliUUst j
include, as a minimum, the following:
(a) Use of a che;nsf-cuetedy SiiW6iSiiu8i6Hsibliform. The original shall iiiuM l
accomgany the specimen to the HHS-certified laboratory. A copy shelHssst' accompany any split semple;speIcisiiii The form sheltis0Ebe a perir.er,en; record on which is retained identity data i
j (or codes) on the einp;cy;; MdGalbr6siilliridifis[spidisiesland information on the specimen collection process and transfers of custody of the specimen.lf*~"Z Filiiisiiiiirissi6iis"6f"GisiinsiiiiFi:itesiiiFFDjisac7ihusdiiiiiisinedMo!M4. "foihuIrielsW l
quired:W526;7.1 byand NM00lilMbonipletior@$11}ssafhroceedegs faintedM8ssjiolation, whibbev5rM(ated j
W;;:nd coalici forms moording specimensjidhiogative instjesultsfadd ii6fFD3ioisti66s drisonisiae%%destrosed afterlappropnate summaryxinformatiodhsbeerdili6&dedf6r i
iii6bisdUiidministrieim pursximes; (b) Use of a tamperfevident sealing system designed in a manner such that the specimen container top can be sealed against undetected opening, the container can be identified with a unique identifying number identical to that appearing on the cheinef-cue:My ~Wi5iF56nti61 form, and space has been provided to initial the container affirming its identity. For purposes of clarity, this requirement assumes use of a system made up of one or more pre-printed labels and seals (or a unitary label / seal), but use of other, equally effective technologies is authorized.
(c) Use of a shipping container in which one or more specimens and associated paperwork may be transferred and which can be sealed and initialled to prevent undetected tampering.
(d) Written procedures, instructions, and training "iUsishelf-be provided as follows:
p (1) Licensee collection site procedures and training of collection site personnel shall cleariy emphasize that the collection site person is responsible for maintaining the integrity of the specimen collection and transfer process, carefully ensuring the modesty and privacy of the individual tested, and is to avoid any conduct or remarks that might be construed as accusatorial or otherwise offensive or inappropriate.
j (2) A non-medical collection site person shall receive training in compliance with this appendix and shall demonstrate proficiency in the application of this appendix prier to Si46hs serving as a collection site person. A medical professional, technologist, or technician licensed or otherwise approved to practice in the jurisdiction in which collection occurs may serve as a B-24
, ~..
1 e
collection site person if that person is provided the instructions desuibed in M3 2.2(d)(3) Bfltliis s@Ipiiiidi$and performs collections in accordance with those instructions.
(3) Collection site persons shall be provided with detailed, clearly-illustrated, written 3
instructions on the collection of specimens in compliance with this part. Individuals subject to testing shall also be provided standard written instructions setting forth their responsibilities.
RThe option to provide a blood specimen for BisTxiiissisWhiiSnihg?idditi65sl EiflIOEencM" positive tiodRaii" lery) breath test shelFfnust#e specified in th toiliEing a a
provided to individuals tested. The !ae:ree;;ene ehell ;lee ;OM the; %;;are te requee; e nea';rra Lii bc-d Me;!ad;-xM the; the 'ad;i;due eee.p;e ;he Reeth ke; reeul13.
b 2.3 Preventing Subversion of Testing.
Licensees shall carefully select and monitor persons responsible for administering the testing program (e.,g., collection site persons, le:wreLif "~lisNisqRs6il@echnicians, specimerMetmersysidliillisliiiI(65Esii, and those seheting 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. AFAs-a minimum, these measures j
shall p~ sis [ ensure that the integrity of such persons is not compromised or subject to efforts to i
compromise due to personal relationships with any individuals subject to testing.
M%s-a minimum:
(a) Supervisors, co-workers, and relatives of the individual being tested shall not perform any collection, assessment, or evaluation p,rocedures.
lI6FliisiiMIUF31eodiampensonnesisisiEK$siWdW$sisss6sdndips6deh@Uis sdehiHlijnegonMMEED gegrae@c[Ilii[eneent.,Wj
~dssiin$() Appropriate background _ checks and psychological evaluations o" f hisif pe e speibli($32M snust shelFbe completed p.tr ;; @s{assignmen; of any-tasks dwgassociated with the WWadministration of the program, and isusfshelFbe conducted at least once every three4Fe~} years.
j hp Persons [ip5ElG@id26.2(ah responsible for administering the testing program shall j
be subjected to a behavioral observation program designed to assure that they continue to meet i
the highest standards for honesty and integrity.
2.4 Specimen Collection Procedures.
I (a)" Designation of Collection Site." Each drug testing program shall have one or more i
designated collection sites which have all necessary personnel, materials, equipment, facilities, and supervision to provide for the collection, security, temporary storage, and shipping or transportation of urine or blood specimens to a drug testing laboratory. A properly equipped mobile facility that meets the requirements of this part is an acceptable collection site.
(b)" Collection Site Person." A collection site person shall have successfully completed training to cany out this function. In any case where the collection of urine is observed, the collection site person must be a person of the same gender as the donor. Persons drawing blood shall be qualified to perform that task.
~
l (c)" Security.8 R,e purpeee of th;; peregraph ;e Mlilii$KgipcWied to prevent unauthorized access which could compromise the integrity of the collection process or the specimen. Security procedures shall provide for the designated collection site to be secure. If a collection site facility cannot be dedicated solely to drug and alcohol testing, the portion of the j
facility used for testing shall be secured during that testing.
s B-25 n
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-.e.-
i (1) A facility normally used for other purposes, such as a public rest room or hospital examining room, may be secured by visual inspection to ensure other persons are not present, and that undetected access (e.g., through a rear door not in the view of the collection site person) is impossible. Security during collection may be maintained by effective rc striction of access to collection materials and specimens. In the case of a public rest room, the facility must be posted against access during the entire collection procedure to avoid embarrassment to the individual or distraction of the collection site person.
(2) Ifit is impractical to maintain continuous physical security of a collection site from the time the specimen is presented until the sealed container is transferred for shipment, the i
following minimum procedures shall apply: The specimen shall remain under the direct control of the collection site person from delivery to its being sealed in a mailer or secured for shipment.
The mailer shall be immediately mailed, maintained in secure storage, or remain until mailed under the personal control of the collection site person. These minimum procedures shall apply to the mailing of specimens to licensee testing facilities from collection sites (except where co-located) as well as to the mailing of specimens to HHS-certified laboratories. As an option,
)
licensees may ship several cpecimens via courier in a locked or sealed shipping container.
(d) " Chain-of-Custody.8 Licensee ch ;r.-ef-ared6MMELQ forms ehelliiiQst be property executed by authorized collection site personnel upon receipt of specimens.
Handling and transportation of urine and blood specimens from one authorized individual or place to another shelfiiissfalways be accomplished through chain-of-custody procedures. Bis 6ii
" liiliiMsUstiWeiocshisiinilisiWsson*silsi'ijsiiiiraon mueGiiiiiisisitiediiiiNiisiiiissimeri c
bem(Mdd nGropinimen tionssisnit biir teshisinern Besiiwie sessing imboreidr#i6edws6ided, sanisr;.irisent shippinic6htai6si y3saensnisg# dtiEs2.sspfcouderssaxpsess
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- messasstsherslifhiNwquimmen[that 50cKpersonnel d66 ament chainWeea%Bh'ths isuetodeansooidret fanns issHng $% tracking systent providedK#iejcoune transitJoussodyac56a' tabilitilirshiishipping'containsis n
'durinl(shipenent aset bs]maintair cerfierZotpostalservice%Every effort gnustshell-be made to minimize the number of persons handling the specimens.
(e)" Access to Authorized Personnel Only.8 No unauthorized personnel shall be permitted in any part of the designated collection site where specimens are collected or stored. Only the collection site person may handle specimens pnoHo liMiss their securement in the mailing or shipping container or monitor or observe specimen collection (under the conditions specified in this part). lr, ecti:To promote security of specimens, avoid distraction of the collection site person, and ensure against any confusion in the identification of specimens, a collection site person shall conduct only one collection procedure at any given time. For this purpose, a collection procedure is complete when the specimen container has been sealed and initialed, the ehem-ofsastody MEE;@sQ form has been executed, and the individual has departed the collection site.
(f)' Privacy.8 Procedures for collecting urine specimens sheltiiiuifallow individual privacy 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 1
exclusive grounds constituting a reason to believe that the individual may alter or substitute a urine specimen:
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(4)(2) The individual has presented a urine specimen that falls outside the normal
- temperature range; and li)]the individual declines to provide a measurement of oral body temperature by sterile thermometer, as provided in paragraph [23(g)(44)@fof this appendix:
or lilfthe liiisillisiffpral temperature deee net aC er eae.ed the; ef the epee.,c.er,7sM' 1
j NismMj5NMMiiiliMisiijisiiiissWRWisiilsisii (E')[5) The last urine specimen provided by the individual (i.e., on a previous occasion) was determined by the lebere;.cf to have a specific gravity of less than 1.003 or a creatinine
]
concentration below-iFg/t:WiiiEljibmsTliinissaisiTsFaisTiiisi~dsisiinissidliy&llWiulsw~
^
ElisiTps6liBfuncesilidWeislW?asproiides Oii12J(e)MthislappandisijhatMisisti6n
~;
b!MicensesiiiMaalloiecosimid.
t (S)[4] The collection site person observes conduct clearly and unequivocally indicating an attempt to substitute or adulterate the ee c.pl.""~~3 (e.g., Eteidate urlne in p'e:n s; eve, bk,e l
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i (4)[5] The individual has previously been determined to have used a substance inappropriately or without medical authorization and the particular test is being conducted as a
?
part of a rehabilitation program or on retum to service after evaluation and/or treatment for a i
confirmed positive test result.
l (g) " Integrity and identity of Specimens." Licensees shall take precautions to ensure that i
Mausur@ijiiE5i%ilsisiiMjuplindsd$that a blood samp6[or breath exhalent tub a urine specimen is not adulterated or-diluted @sisissisH3lIli during the collection procedure, 4
l cannot be substituted or tampered with, and that the information on the specimen container and i
m-6iilthe PMZSEMieeerd beek ean identify the individual from whom the specimen was collected. The following minimum precautions ehell Mbe taken to ensure that i
authentic specimens are obtained and correctly identified:
(1) To deter the dilution of urine specimens at the collection site, toilet bluing agents shall
}
be placed in toilet tanks wherever possible, so the reservoir of water in the toilet bowl always l
remains blue. There shall be no other source of water (e.g., no shower or sink) in the enclosure j
where urination occurs. If there is another source of water in the enclosure, it shall be effectively secured or monitored to ensure it is not used (undetected) as a source for diluting the specimen.
(2) When an individual arrives at the collection sit 0 for a urine or breath test, the collection site person shall ensure that the individual is positively identified as the person selected for testing (e.g., through presentation of photo identification or identification by the employer's representative). If the individual's identity cannot be established, the collection site person shall not proceed with the collection.
(3) If the individual fails to arrive for a urine or breath test at the assigned time, the collection site person shall contact the appropriate authority to obtain guidance on the action to i
be taken.
(4) After the individual has been positively identifieddhe collection site person shall ask the individual to sign a consent-to-testing forrruneMdisidua(siii(iiisilfe}sijused-end to list aH
. ef the prescription medications and-ii[over-the-counter preparations that he or she can remember using..;",;,, the pee; OO deye.
j J
(5) The collection site person shall ask the individual to remove any unnecessary outer garments such as a cost orjacket that might concealitems or substances that could be used to tamper with or adulterate the individual's urine, L,ee:h, er L eed 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 blood, Lie;;h, er urine eeraple Wissimen2is collected. The individual may retain his or her wallet.
4 (6) The individual shall be instructed to wash and dry his or her hands prior to urination.
i i
(7) After washing hands prior to urination, the individual shall remain in the presence of j
the collection site person and shall not have access to any water fountain, faucet, soap B-27 p
j J
t
=
i dispenser, cleaning agent or any other materials which could be used to adulterate the urine I
specimen.
l
. (8) The individual may provide his@ her urine specimen in the privacy of a stall or otherwise partitioned areas that allows for individual privacy.
(9) The collection site person shall note any unusual behavior o,r appearance irHhe l
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(10) in the exceptional event that a designated collection site is inaccessible and there is an immediate requirement for urine specimen coSection (e.g., an accident investigation), a public or on-site c"~nehi rest room may be used according to the following procedures. A collection site
^
person of the sarre gender as the individual shall accompany the individual into the rest room which shall be rr.ade secure during the collection procedure. If r,eeeMejsihiidabli, a toilet i
bluing agent shelHisilbe placed in the bowl and any accessible toilet tank. The collection site person shall remain in the rest room, but outside the stall, until the specimen is collected, if no bluing agent is available to deter specimen dilution, the collection site person shall instruct the individual not to flush the toilet until the specimen is delivered to the collection site person. After i
the collection site person has possession of the specimen, the individual will be instructed to
. flush the toilet and to participate with the collechon site in completing the chain-of-custody ures5%iliigidGiiiI^sihiyisiisi"6(diii.Isiiise ~~
lifiisfiiii.w,e6II*#. Giili6issiIis,... hall l
m umm.w v -
w ay nn ~ -^ m a.; a Y.
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SJasmegendor<pesson iifsocompanyJ; in y elodiw,d~u,~m yd~hisDesmon_sh_aB..be.w w-u a
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1 (11) Upon receiving a urine specimen from the individual, the collection site person shall determine thodisliibBiiifit contains d kn' 00.. " ice TijUi"ngifof urine ~siilli6isififsiffdiiiIet g.g+g+
7~w77gggp gg isonneesiiindisses^teiininehmoomosinsnetyisslisiidioensbees pan *8edMWis6saseeT ED)oli6/Miss?iiNfedeliHninid quantBifosish/giiiilididefripecimen ansatincisde7miliast:30 magneurstraf;9iiEtee8ngsid9iisHHS.corSEedlituustoryseguiied under$2${iifot#ilijeppendix issWalesipisisitale seasoniisusemaipniiraonness seesesiEadelonsferuspyWhee co8ected susiinensars saisii%initisindestiniGoomfisiosis(5279iiiifMesieppeedRainsendeissmined issmanly snust inesudis:st times his amanceactFieselshNpiedenennined queesty should: sis 5 prooideMiiiE=ese-s,ienatipialiinia sensesipais:siane^ itiandiceiirnuch tiesinp6__
e cesse1mhere'thsispecimen welumels insulEcienttofuW iillanelysis miid seenelysisveguirements hiFiimdesensined tskshssosaseeD&iEjaped==a shouldiissssedntisiesinirpassitseito meef thoseEEquimmihtsV9iHonoiidng'andeiMisiddtpf testiopitWislspeclisen#WiiihHS-certifsd lobosatorgiirovision hipit'episcirnenfarus onets screening tiets. *Pedial spishimerisliiss ilis@o iesilligM:inigunds) shouldim'$ahs 75MMinMuheequendypogeoted'opecimeMf6r s)MS cottEladlobosadelyMf there is less than 6ewielleister:1ho quangl f urine in the container inquisid is f HMS cesWedIsiishisisipliiii@ additional urine shelHiu@st]be collected &Eisih succoom~ isiDi61djiuiiiiWiiilitected;in a separate container b eeJ, ; 06: 4 00 melleisters. (The temperature of thejitypertial-specimen in eachbseparate container sheiHidst be measured in accordance with paragraph (M (fi)(13) of this section, and the perteel
)
specimens shalHisifbe ee.7%c.e4 h er.e eer.3ber lisiiiidsdTs~iiiii6iiisliitiiledlsidiIdEriliid fuilsiiiNiisiifipiiicimen tliiiifiiisifiE%isliiiIsiifefAliM$iintimevaipuiresnentsi) Eistdi specimm must lasMu@iiisinrelety ini(analysis. The individual may be given a reasonable amount of liquid to drink for this purposei(e.g., incisiiBilaWKsE glass of waterjiiiIeystfiiilisiiis3iilil3iiDE556iMid..
EIliisiiiiiiisiif Wiii)iljiiiiiialjilsjiRilisiisiisies,pioidadopninedjiyju[ellidihasil the co
. If the individual fails for any reason to provide s quentiti of urine pufficient ici3tSBMII980lmislan site person shall contact the appropriate authority to obtain guidance on the action to be taken.
(12) After the urine specimen has been provided and submitted to the collection site person, the individual shall be allowed to wash his or her hands.
1 B-28
.o l
i l
(13) Immediately after the urine specimen is collected, the collection site person shall j
measure the temperature of the specimen. The temperature measuring device used must accurately reflect the temperature of the specimen and not contaminate the specimen. TIE lEiisissisIslialllisiililislGliiP~~"4W7IdlliliIsilii6lIIIishis6ihishiisis iefsitilIIEr~fidsiliiU s
based:VEEsitp measunng doispeci_fic_ facto _rs4heu.nsuence;sinesults.i._t(in. clu, demsi..tiji_s_sf i
9 ime l
ncesfusedf te;amtmanttoegardusett.~ j_oen;tskieh.onjo,compiehongthe
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semperattsgsneseurerneakendhdherfactosGMicenseepheBcleartyspeclipNtemp si6re rarige}isswfecsonisiinwaresistasisWii?rahoeitititutconeason proceducesphs largeratumsangeif a6aicciptableTaine.speisiinertsshe@.iWilhidlbendl.oG106]EMER
%iihilowe@nitMWNsesMQ9n3The time from urination to temperature measurement isetiested issatiin no case shelf-exceed 4 minutes, EH.. dim. a.ij.is...isiid.B.~Vsl5.is (46)(1A) Immediately after a urine specimen is collected, the collection site person shall also inspect the specimen to determine its color $iiiiiiiiHiiEand look for any signs of contaminantsWadsliiiiii65 Any unusual findings hiust shelfte noted la 'he pr.aenera record beeldsiD,e A%issMastodpand-con &6I)diin.
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.v e reasonito believe :thelindividuall map have' altered lcr: substituted the ev specirnon cEused b[@pecien@tes!g@sature falling'odisideMisescribed rangei ~ '
, [ii)Tihere is a reason to believe that the individual may have altered or substituted the spccamen becausd"asiE6i'56iiifsniisWi&i6ii"silidiIniIridfniif6EEiiiiiiiiEathei{ isis 6616 MaeEUGEjihndwiddiikstleMplindt6]sutwyrtjidiestingbrocessManoiidr skecimer$ '
shelf 1nust be collected immediatelp)under direct observation of a same gender collection site personSKh6llisilsH"Elteiperson ofDis'ssiss~gendiflidi6FMihiili6shisiisliialGiiblect s hihii" gender ebee6MrWebservefiliill SiibriosediiiE^i missist mahGsroceduies$sThei same gneasurernentsJpustMerlohnodji@lis)isdi@jipedineiiy and both specimens shelf is6ist;be forwarded to the laboratory for testing. Ar5 lrfdMdue' _cr.e, velut Jeer te beve hb er her i__
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(16) All urine specimens suspected of being adulterated or found to be diluted shall be forwarded to the laboratory for testing.
(17_Wh_enev_er t_he,re is reason to believe that a particular individual fisiyhiyi)llibiidM
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a specznen otmay alter or substitute the un.ne specimen to be provided, a second
d
r specimen shall be obtained as soon as possible under the direct observation of a same gender collection site person. Where appropriate measures will be taken to prevent additional hydration.
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B-29
e earnpl ehed by re ee; ag the ebeve pree.dere en ene:her ev; den;,;l-grade breeth ene y3:3 r
devree-j8fJGiifoliidliiiiiihiiiiiiGIHiiiiiif6iIpiitiiiiiiiiilgsiiWFET~"S&Bi~esijgi5isiifsi siNisinedMs assets >1iiferampenexanstaquipWmeis musi%uwanoooodance wth as:imanufaceusesw=*== tOndheduais malnediiiiidinancient gesaisiveWiisiliaiprasnm
!ItheniliiniesconMandlovyahusiiiiiiisCilochotiesWineuth'azistsjsMbreathyestiFpier3r Botectior6if#iiiE8tsfisseenliiis tmealh specimen mestiiiiidelayedfl5?ninutes316
- +=na4btesimeserie Jaf eiininelysWht1hiferst eceisoning tumesi:specimeriW:essentisily zeiid41esiEAiinises)ementencktiejtsikuiiiooneidsed'ne~ elividirisn61udhertes6ngis g
pquirmsWM ire $viduefishoosinistisceiiinsungtreasP =EMiifsisbove0:01isIrdsis BAc%iihesondsomeningtematispecimerkesinosiseceediliid:siiinparedsstiiEisariis ~ ~
inlOipinentliliif81ii:9fiiiOBCreening 4 pea 9fipecimesiniiniiufitiiiidfininuleshnfh6:lisiittishl10lWi60tsi assisiiiifanilspeciaihiaWaaaare=OsteistsE% pace==insiiiimehirijili'sMninus30 percent'bf IliiiinnisisisliifMiis$isiifmessisenicais?$siliiWidscsMississout&siiinisidereidliibcurliiite ^
ilisisiiinsoninginefinismiiiiisifismiimatisiniisliidiisiiiipaissiliiiiinido sweeth tsiits1must tis ~ ~
reinsetodisn:enomer essensies:sede amesa analysisasuiceweistna possumi6uilio pement;BACM piirachievedWnhiesult sf usiiFacreening asst:lijrealetof~s percentaccuraa sananing3estemosman18arananometevideniinHnadeJumam aneiraisidevice:
(19) If the alcohol breath tests indicates that the individual is positive for a BAC at or ali6GIIMii(8% pes 6sst?Wjiss(W#iiintisTridlilif6El~siiiif6ssiitNIesifis"sliiyiff6izsLBA above the 0.043rcent cut-off level during$sciseduledydtid6sdidtiinNfdirmats.ry testresult betweest002 percoast;S6C arx%0ipeacent'BAC), the individual may request a 1
z cenGn ne:er - blood test, at his or her discretion 286ittieliuspoiiiiW6tifiiiihisifisidiisshsil
'hl6issilish stiiksiidMdisilisiniid.TddasiffrDiijspiifM)lood speciepen shouldM)rE s
immediateijdpossble All vacuum tube and needle assemblies used for blood collection shell s
mustpe factory-sterilized. The collection site person shall ensure that they remain properly sealed until used. Antiseptic swabbing of the skin shelFiiiilsibe performed with a nonethanol antiseptic. Sterile procedures shelHiiusilbe followed when drawing blood and transferring be blood to a storage container; in addition, the container must be sterile and sealed.
(20) Both the individual being tested and the collection site person shall keep urine and blood specimens in view at all times prier is M#their being sealed and labeled. If a urine specimen is split (as described in Oestien S 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 semple 'pislissij or the transfer of the specimen and the placerr'ent of the tampers s
evident seal over the container caps and down the sides of the containers.
(21) The collection site person and the individual shall be present at the same time during procedures outlined in paragraphs (h) through (i) of this section.
(22) The collection site person shall place securely on each container an identification label which contains the date, the individual's specimen number, and any other identification information provided or required by the drug testing program, if separate from the labels, the tamperkvident seals shall also be applied.
(23) The individual shall initial the identification labels on the specimen cente:ners S6ttles for the purpose of certifying that it is the specimen collected from him or her.[Thsispecir5en bottles]isisiffseIcisitifeeilidKgsssinfijhdiis6isidiiiipsH5gl 3
G) The individual shalFmustiid6)e asked to read and sign a statement on either4he j
che:n -eLeuetedy M'si%oontroljorm er la the perinenent reserd beek certifying that the i
specimens identified as having been collected from him or her are in fact the specimens he or she provided.
J a
l B-30
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(254)Mi!ssinier$2CdiiiMKdii supervisor la ;h. drug it.';as pingram 5'Whiis$risisdrsilliiiiiiriMiississalldifAs highe isi!6tiislisil]in advance with1mrMisslidecision by e a:LMbr. d% pereen to obtain a urine specimen under the-direct obsurvation[5[W^MJWi[(@5) of e eeme gender celket;en i;{pereen beeed en e reeeen 's be:k.e t'.e; Ce nd!.idad mey d%; er sub4 u;e 2e spee: men s.
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(266) The collection site person shall complete the d.e:rref-cue;edy Sistoc{Eississiiptrol
- forms for both the Mque; 5---fiigiiEI@isifand the split eempMTs~jiiiisl5iiirj, if collected, and shall certify proper completion of the collection.
(276) The specimens and eh.:n-of-c.dedy P9_Qi: isis 6[ forms are now ready 16 lfpiii:Is@sd for transfer to the laboratory or the licensee's testing facility. If the specimens are not immediately prepared for shipment, they shall be appropriately safeguarded during temporary storage.
(2BD 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 shelMnot leave the collection site in the interval between presentation of the specimen by the individual and securement of the semples sjiisihiiisiswith 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 ssiliiCspecimens and chd,ref-cuetedy EWLi. dE6hli6ljforms sheti TriGs(be taken with him or her or shelf EiGiii(be secured. If the collection site person is leaving for an extended period of time, the specimens shellinuii(be packaged for transfer to the laboratory before he or she leaves the ji611sciisn[ site.
(h) 8 Collection Control." To the maximum extent possible, collection site personnel shet!
HRis(keep the individual's specimen containers within sight both before and after the individual has urinated or provided a bree:h er blood eemp;eIngissimen After the specimen is collected and whenever urine specimens are split, they shelhaust:be properly sealed and labeled;to P EUIslIIrsleissisBDidiisili@ M6Nssil663llifibersd6MsjihiiETshistJddhiisi.the E
sp661rnarfiiisus3A 2.eb-ef-cum d N-WF-- 'ispifsjiiiii6srisprom the point of collect i
-Aform shelthiiss[be used for maintaining control and accountability of each specimen incluiling to final disposition of the specimen. The date and purpose shelHnust!be documented on the che!.ref 'uMed E3Z W EE-Zform each time a specimen is handled or transferred, and i
every individual in the chain of custody iisistshelf-be identified. Every effort eb;ll j50sijbe made to minimize the number of persons handling specimens.
(i) 8GjiiBijssQrispassiliin~]sF, Transportation to Laboratory or Tes'.ing Facility.8 Collection site personnel shall arran _e t.o_tran.is.h._r the colle.c_te_d s
' mens to the drug testing l,abora,to o..r sfe lan pru. sc ons
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(42.aWinahi@hoisiiWholsidiinFSpecimensismustbiisiiihtMBis:Hl5cerWied hboWiil6i9 gaggiig'a,igsis.e,isesy,_ciiiinsgeigie.gs,icopiandaranusual cidiGmstad6h@i,s_liis,isbetwesh
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inuc^ eifMinouriilliinis%5is%stiiseenshipsgen6iis@Wiii[iBreening3illiGillhs HNS-cejitifisul e
labbraiorwsxo.iam_ioarsa.n r.axer epe.ceae =: er :=;;e.ecessag.ad er e sewad
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_ ~ -__ _.___
~ _-
______n
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Ehd5 WW4 0.4BM %#%F5 55 55 5 5 9 4 5 g.3 5.lg SE@.5 f 5 MW W%EI E Ef M T.
95%3 T1.P @f.1.FU5ET.I5@.55%8 45 M.03@B.55533g @h5@f.),
B-31
~ - -
4 n
1
, e !aberebr - br en"biillEGife:e under r "; cr.aeee:ag p^ecea 2.7'"", :ta Ttsii
., ~ne ibiTcB6n. M~
unisiiKIsisi 1liiiiiIS~hTiutttii'iG
~
itssoafliatsd urig@gu$edstest bdlgsqSietediendiabeledispecimens bottleAM t i
- gle$e$lilosMLEggtls@gilltNunefedgdsiiiliEMsiiBidildiT51sWhsMsstesting cu j
lahomilcip]viii,% shelf-be placed in wob,are Me60sil24emper4Wident shipising;contai!iiir]iishish paiet)s] designed to minimize the possibility of, damage hiMiii[ssiecimen]during shipment (e.g.,
specimen boxes, padded mailers, or bulk iniiiisiiii? shipping containers with that capability and j
thesesiE9iilWeofisslEifMshlijiiiili{cordainels si@i(M_acdisilblijiistlisGOind)40ng^'s tamper vidertennish= de eesrey scd = =.a:ra ra pees;=,;f er undeu%d 4
- s, ipciag. ca ths -p :f g ths saa: :,.sc, the e:"::ba a:a preca shs: & ga sad sater the i
de% eps;a ia..ne ::ij la re waM;eere br eh;p. Tan;. The a::r.=en ;;% pereenne: shell eneure i.e;;ta d.e!Tefw-edy de-:aTaoM.;en le e;; etad ;c enh cenM;ner see:r.d Mc j
eh; pia.a; O the dr ; %e;,a; ;ebe,eLij.
Q8Fanum to Cooperate." If the individuaQNiiiiii@WinfissiiWiiiiki6Ejii66iiK5(
j iiiiiiihiiles refuses to cooperate with the urine collechon or breath analysis process (e.g., refusal j
to provide a complete specimen, complete paperwork, initial specimen; pnsiilsilisi:omii6diir ihbiiiiiiiiiiifjiiiissilinldsIhili66), then the collection site person shall inform the atd;ee: Rev ee ONicer-appeopdehifsulhodty}and shall document the non-cooperation la ;he penTeaea; rewid i
beek end en the specimen custodyfand? control form. The MRO ehe:: repe,". ;he failure to cooperate sii6silisliiiiiiisd^1iiiisitSanil/Ei[eislM RisliiTOlli6sffthiEFFD*Phidisis IWhsisijii76Eto ;ta eppi pr:et Mmanagementlhavirijliiised stikn6wfaiilapiiiispriatW6f fyrther2achori The provision ofiiEblood specimens for use isiss?sppeai%e cea';nr. a positive breath test for alcohol shelifrifi4be entirely voluntary, sikhiustjhejat the individual's d sere;;oa 6isiiss la ;te ebanee of a ve:ua; rj bleed teet te eewad pee ;rse Liedh tee; stell be
-......... -.......... p s::.se.
2.5-HHS-certified Laboratory Personnel.
)
(a)" Day-to-Day Management of the HHS-certified Laboratories."
(1) The HHS-certified laboratory shall have a ge=';ed lr dMdse fisiji66'sibliliisisoH to assume professional, organizational, educational, and administrative responsibility for tiu j
laboratories 93 drug testing facilities.
j (2) This individual shall have documented scientific qualifications in analytical forensic toxicology. Minimum qualifications are:
l (i) Certification as a laboratory director by the appropriate State in forensic or clinical laboratory toxicology; or (ii) A Ph.D. in one of the natural sciences with an adequate undergraduate and graduate education in biology, chemistry, and pharmacology or toxicology;{ or i
(iii) Training and experience comparable to a Ph.D. in one of the natural sciences, such j
as a medical or scientific degree with additional training and laboratory /research experience in i
biology, chemistry, and pharmacology or toxicologyd and i
(iv) In addition to the requirements in (i), (ii), and (iii) above, minimum qualifications also l
require:
i (A) Appropriate experience in analytical forensic toxicology including experience with the analysis of biological material for drugs of abuse; and (B) Appropriate training and/or experience in forensic applications of analytical toxicology, e.g., publications, court testimony, research conceming analytical toxicology of drugs of abuse, or other factors which qualify the individual as an expert witness in forensic toxicology.
B-32
(3) This individual shall be engaged in and responsible for the day-to-day management of the testing laboratory even where another individual has overall responsibility for an entire multispecialty laborr.ory.
(4) This in'!,vidual shall be responsible for ensuring that there are enough personnel with adequate. training and experience to supervise and conduct the work of their testing laboratoryies. He or she shall assure the continued competency of laboratory personnel by documenting their inservice training, reviewing their work performance, and verifying their skills.
(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 sholdiiusfbe reviewed, signed, and dated by this responsible indmduel jiiiiiiisi whenever procedures are fir ~st placed into use or changed or when a new individual assumes responsibility for management of the ils5]iiBil5 laboratory. Copies of all procedures and dates on which they are in effect shalHisis(be maintaine,d. (Specific contents of the procedure manual are described in Seehon 32.7(0ji) of this appendix!)-
(6) This individual shall be responsible for maintaining a quality assurance program to assure the proper performance and reporting of all test results; for maintaining acceptable i
analytical performance for all controls and standards; for maintaining quality control testing; and for assuring and documenting the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(7) This individual shall be responsible for taking all remedial actions necessary to maintain satisfactory operation and performance of the laboratory in response to quality control systems not being within performance specifications, errors in result reporting or in analysis of performance testing results. This individual shall ensure that test results are not reported until all corrective actions have been taken and he or she can assure that the test results provided are accurate and reliable.
(b)" Test Validation 5 The laborator
%dMdueye) @@ifjiii M@Mjiefrj@y's urine drug testing _ facility shall have a qualisedM s
59M29908 who reviews all pertinent data and quality control results ;n erder to attest to the validity of the laboratory's test reports. A laboratory may designate inere then ene pereen te
,_'2_.pr erm ;h;e 'unet;en. Thie indMdue!(e) mej be any err.p;;jn he le que!;';ed te be ree ene!ble
,_m. _ _. g+gg m
2_.
______.s_
m 2_ _ mm_
IIifidsdiHiEfe5Il5EisiiWSI5Wr5isfhif5fiiiisfiassiidsoniryinoisaientingst isshualHedjd[WjssthIshitia@iiiijimliNWal6ij)its.
(c)
- Day-to-Day Operations and Supervision of Analysts." The laboratory's urine drug testing facility shall have an individual (i) to be responsible for day-to-day operations and to supervise the technical analysts. This individual (s) shall have at least a bachelor's degree in the chemical or biological sciences or medical technology or equivalent. He or she shall have training and experience in the theory and practice of the procedures used in the laboratory, 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 test systems being out of control limits or detecting aberrant test or quality control results.
(d) 80ther Personnel.8 Other technicians or nontechnical staff shall have the necessary training and skills for the tasks assigned.
(e) " Training " The laboratory's SiWiEilii@ t ssting program sha!! make available continuing education programs to meet the needs of laborato,y personnel.
(f)
- Files." Laboratory personnel files shall include: resume of training and experience; certification or license, if any; references; job descriptions; records of performance evaluation and advancement; incident reports; and results of tests which establish employee competency for the position he or she holds, such as a test for color blindness, if appropriate.
B-33
2.6 Licensee T 3 ting Fe:My Personnel.
(a) 8rhy-to-Day Management of Operations.8 Any licensee testing facility shall have an individua' to be responsible for o4y-to-day operations and to supervise the testing technicians.
This indivMual(s) shall have at least a bachelor's degree in the chemical or biological sciencesj er medical technology} or equivalent. He or she shall have training and experience in the theory and practice cf the procedures used in the licensee testing facility, resulting in his or her thorough understanding r3 ouality control practices and procedures; the review, interpretation, and reporting of test rasds and proper remedial actions to be taken in response to detecting aberrant test or quality cordml results.
(b) 80ther Personnel.8 Other technicians or nontechnical staff shall have the necessary training and skills for the tasks assigned.
(c) 8 Files.8 Licensees' testing facility personnel files shall include: resume of training and experience; certification or license, if any; references; job descriptions; records of performance evaluation and advancement; incident reports; results of tests which establish employee competency for the position he or she holds, such as a test for color blindness, if appropriate]
{
and appropriate data to support determinations of honesty and integrity conducted in accordance with 9 2.3 of this appendix.
2.7 Laboratory and Testing Facility Analysis Procedures.
(a) 8 Security and Chain-of-Custody.8 (1) HHS-certified drug testing laboratories and any licensee testing facility shall be secure at all times. They shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle specimens or gain access to tne laboratory processes or to areas whera records and split semples-flifuB5ienE]are stored. Access to these secured areas shall be limited to specifically authorized individuals whose authorization is documented. All authorized visitors and maintenance and service personnel shall be escorted
- at ail times in the HHS-certified laboratory and in the licensee's testing facility. Documentation of individuals accessing these areas, dates, and times of entry and purpose of entry must be maintained.
i (2) Laboratories and testing facilities shall use chain-of-custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results, during storage, and continuing until final disposition of specimens. The date and i
purpose shall be documented on an appropriate 3,;;rref-wetedy EZCW2 form each time a specimen is handled or transferred, and every individual in the chain shall be identified.
Accordingly, authorized technicians shall be responsible for each urine specimen or aliquot in their possession and shall sign and complete f.e:rref-wetedy F-l]TMdforms for those specimens or aliquots as they are received.
(b)
- Receiving.8
)
(1) When a shipment of specimens is received, laboratory and the licensee's testing facility personnel shall inspect each package for evidence of possible tampering and compare L
information on specimen containem within each package to the information on the accompanying CTZ22 d.diref--wetedy forms. Any direct evidence of tampering or discrepancies in the information on specimen containers and the licensee's d.e!.ref-w;Wcisiisiephi6d 56H65l forms attached to the shipment shall jjist be reported bl#7ae H$6ibille@ horst 6iy within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to the licensee in the case of HHS-certified laboratories and jiiuss( shell be noted on the laboratory's 2.diref-wetedy TT]HE2 form which (6EiI shen' accompany the specimens while they are in the laboratory's possession. Indications of tampering with l
l b
I
.-. _ -. ~.,
l 1
specimens at a testing facility operated by a licensee 'hUst shall be reported within 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> to t
senior licensee management.
j (2) Specimen containers will normally be retained within the laboratory's or testing facility's accession area until all analyses have been completed. Aliquois and the chsin-cf-I csdedy Esist6dfshdJcordioijforms shall be used by laboratory or testing facility personnel for conducting initial sdeening and confirmatory tests, as appropricte.
c) "Short-Term scree,ning test and,pd._Re_frigerat_ed_St_orage. Spe._ci. mens that do no._t receive e
~_,
appropnale a, confirm _atorytest with.in seven one da.-.i am. val at the HHS-c yso a
cerufisdjab6 Fit 6ty; or are not shipped within 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> of collection from the licensees.6611esti66'or testing facility and Esiselfss any retained split specimens. sh.all h.~idil be plac,ed in,s, e_c_ur.e.,.-
refrige_rati.
-.~.
.the spec,i.m.. ens sa..c.. N.-. iled cond. i. tion--
j unt<l testm,~_on_u_ nit,s _or o.ther m. eans:of._.s._ec_u. relys,am.~is.
n-3
~. - ~- m t_.....
_i-g or!shipmest. Temperatures shallmust not exceed 6'C/43fE. Emersicacy pceccr E U;sment Contiragenbi^issisuM65stshell be available 16~disihiainjthsT5psdihsiisRa Eliitf6d sbetE in case of prolonged power failure.
I (d) 8 Specimen Processing.n Urine specimens identified as presumptivelj positive or;as i@ssii6hs6Ielf6EIdUhsisii666Edildtiddby a licen:.eWs testing facility shelMidst be shipped to an j
1 HHS-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 i
vary significantly depending on the size of the laboratory and its workload. When conducting
{
either SWe^shidglinitiaFor confirmatory tests at either the licensee's testing facility or an HHS-certified laboratory, every batch sha!!fsnit?contain an appropriate number of standards for calibrating the instrumentation and a m.1-ve.gN.v.y.Wre.,e+rurAX/W.syty/ percent controls. Both quality control and
~
inimum of 10 blind performance test samp.es 3.
specimens must: appear as ordinary sampies1pecimens to y.-
ye.v y. W e '.. ve :mv.-
laboratory analysts. Special processing may be conducted to analyze specimcns suspected of being adulterated or diluted (including hydration). Any evidence of adulteration or dilution, and any detected trace amounts of drugs or metabolites, sha liFJsf be reported to the Medical
_ Review Officer.f.iT6FMRO s.E,. sif_iepi result from an: acceptable reason.iii?any'addits.f.a. tI.66"6f.ililutiS.~Esiidsh6E.. fee. ld
~~
n
+ c
)to managementirnmediately) r.
ing (e) Deth....,...nin.y r
o..., g Spedir6
- 1) L,icensees sho..... d.. -.. e..r.i.,P.; *idity2. e.d. ?n.n-me.ow+gs.. te a6tions to.s.
or,.;y,~~
. ul take) 1entan appropo assure.specimenvalidity;.(
.cr e.g
,. pw,r.a x-w. -
.g DsVI6. Es[iu.sud_18de. termine Valid a
/
Ispecim. enMsiWA,dd,fthefollowin_if_ied1s,bo_rstor n
siM. csri be,iaccurateland not contamina?.
fpecimennA. ~t!a minimum gTactions must~be
.- ~
taksrd!Spscirherisitfial;srs te} ydsd atltheiliosd5eeViesling' faciliffrhUst)irst bs tested f6r dbatinine7:pH/shdYstnies.s.lqif 3..+.:3pebir6snYbre~ stmine"66tident.ratiori'. isles's than 20ihiiligisins
. l ;.4 W -
4-
.,.r
?
c
-w,m, t
--:--<r,:
, : n; y
..Q<
e..%.^
per; dei,' [' terlif the pH 'is'r;,l'e.,lss. t'ha' n 4. $'m./< y'<;or gre'aterthan:;,8.0L' if th....ye nitrite,concenirsbp..:on is' y-%equa'l cni x
!skslettfiarL500)siciogranj5 hsfmilliliter/of if,tneie:is btherlevidencei6f sdultefantsEthe specirhsrOnust tssient 16 the}fHS-certified laborat6'rp f6fWodaisirigEHHS? certified lab 6 Fit 6 des inGst2tesfWesiipecimensi6d sil:6th6Fud6E~specim66s foNyarded undsf thsp6Visi6hs of minim;u.ki.?.
$,26124(d fid. d.:etermins16 p mssuch testing,;/<~ 97_ e.,e..u %yslid.y.t.,y^a., n.d. idli.efed.;s.aden. 6.,a6o t5
~
i
- 'yrQ r ^
t
- ,9...
.. g;_s-a n r
% nc.s--
ys must inclu,...i. ade: analysis for:, ;c:re::a't'inin.$y.e/pH'iand' nit'ritesnif a(v.:s'specimer
- h. ~eatiriirsd. oh.. eshtration kishi thaFE20fnllligramsfpetdsciliter2thelab6storimuslimeasuis the specim..e. n_'s s,pec. ifi,c g~ra~.N..
br shng using
~
(2))A valid spac,onen,a_cce_pfai, sis,.i._ie _._th_e cut-off k,N, ls,,in $f1.,
.@. _,d e
7(f) an 27@X2)'6f fissWpehdidat%it6sti ficenses's'testidd fasilitNXHHS-certified laborat6Fylis fres#adulteishts;shdihaWidrestininslisVelequalto:4dsatefthari20 milli ~ ramsper#eciliieh g
a iha,p.~. -Liisiibetweena.u$,:shd8.0i.nclusiss)?,andi. nitriteboheentrationlesittiadiS00
.~.
~ -
-wi -
x-f 4
saulteratedZdiletsdM6fbeshonabis salidity; v.
WX.::,spe,nirs._erfis16sv.,.lidjifyist,eltherid.~ildisdl6i"idslisiS(sdWii5..sDF6s#1s16sialidifh c
a mw as, +. n
,v
~
e.
. ~:.n~
~
.u-~
..,n c..
Ce.WQ%.. ~.. ~.. W~..,, ~~ - c. >,M[_,MWJW.-w~s[<7&sQ W.s M [.h.&RQQ&,@eb. - ~ iMMW
?
Y Q..
B-35
s%isbifsEUFsWTMsasUfssisNinpisTdiWaiftnin%C0f6E~sh4G5sG66%ittiliiispsafis Spavitp measdrernemt eduall16KgreatQtlyfD20Mgmeastaementlechai idyleQttisQ.5 4
or equal to or; greater than1t0lc nitrife concentratirm. equal 14 or ograms i
pARmillilateMbr if it hss'detehtatndadOlt$ rants) Wheriilahdrathi/grerater than :500 dsterrnines:thsO insalidfit need hot? conduct itsther issti6gibut must esport stWpossibip)0dtsdjotadalterated bondition;:and,thelqdan,titated jesults:#all:1sM,nd~ tith,eomRO, sM
- ~
[4F A specimer.of questionable validity. Esp
. en th. t_c_onta.._ det,ic,iable ms no;.e is a
5dUisistitsMd shows evidensel6f dilutsonWhsdidte hombisdd crsAtirsde/Agiecifid grsyiiffsiutt
)
thst islisbisreoria"creatiniine conochtratichiester;tlia67 niiBidraddisik decilitsf'm36mbinatiori With'a"sp6ctlie'gfasity3estefthant001fand a~ creatinine MMeiodWiess than:20 inilEdrams psf dedster.irisdidsriatinnnrittis%si?ndgiaMhf Jesittsin%003[or159 hsiisgja pH b6noshilati6tigreater;ttsW.5 bLt iseisi;thss9#6rigiesteReiseis;o;tsuintharinoF Specimens;detofdiined to tRothessrionableialidity'thsst b(snt$ sat $6;scrsersnd tssti6dlusing i
P_DA,n-appi696dls,b elyt_kial,kCgits.sisdW_.m w.e,6f quesh.sftohosntratiod
.it.s. hs lo dfd n
foiths%gy(sesi emg.*ptahla rsnse!ofinegatise s6teenidg controlinspo6sss@hss e-tech oic.
use responses onable donor specuaens mu... bs.st ecorn are,d p
issp66sss thstBNireater;than tha hagatise control responses mustLtisubjestLis?c6nfirmati6n testingWGC/MS st,thelaboratofy's'limifof detestist((LOD)MSu~ch testing;need. tid cond6cted i
ohiy for;thesiabstance(sy^ espo?ided taLiri thelsunening tsstRohantdisd testisiultsinnst bn r
fspdrtsd;;t6MMRO$Nsgahve screesini^results1fsfthistspicialprLbessin61nidst 6eissisWed by the MRO7srfdfif the!MROhasisssoWlo:belisysjtliat Disjiitatis6is thebsult::sf s:subVstsi6n
{
atternptlths"sjiscime6snust!als6 b6 subject Lt6;GC/MS 36stingist;ine<laborafsry's;LODj spea_ men must be collected,as:so_td..etermir.se i..f. thefspecim._ skis.s,. alid._
(5)hVhe6.s > s. M.R.x m badss
- -ejdirectobservation.. f a;c-same gen in O
. - - ~
m
-s-onias.possible undetth...~
- o collectidrUsitWpsrsod)
(eXf) Tr;;;m: nary lnius! difsit{shd i.sS5fst$7Sdrsidihi! Tests."
(1) For the analysis of urine specimens, any screening}renm:ns;y-test performed by a licensee's testing facility and the initiaFscreening test performed by as HHS-certified laboratory shalFis5si)use an immunoassay which meets the requirements of the Food and Drug Admini.m.tratio.. n.for commercial dis.s ributio.%vP,.ssd.in. iMHS.c~l, S... A.M. S..M, s ww.myeww.w.ec #w ass m
.j m 29 :~
c.
- iDsiF..ah t
n.
g wr.w u.s.m.m mstrumented. 3immunoassaytesting a73.g c
c
.o teht,for drugs of
..w..ev...
sbuse[iti NRC-redulated FFDlpr6gradis.$NorPsistrumented dskiessinisitssT:ssd f6f thelestsLto dstermer)eipidinenyaliditiroquisd 69322(e)j The screenihd]initiaFlest of breath for alcohol performed at the collection site shaHnustiuse a breath measurf tnent device which meets the requirements of secuen (2.7(e@)(3)." The following iniil&l cut-off levels shelffiGs[be used when screening specimens to determine whether they are negative for the indicated substances:
B-36
fruheHis6isisilHi' test cut-offlevel (ng/ml)
I Marijuana metabolites 40050 Cocaine metabolitss 300 Opiate metabolites 1 300*
Phencyclidine 25 Amphetamines 1,000 Alcoholt 0.04% BAC d25 rig /mi is immunoassay specific for free morphine.
%MWWIsiigfi[sfIsl6ohldlTs7EiisissijT6166d sie stiesstupon'dahira6saahoiwsoo istilisersMblii6dWaamatu#alochoQieE2nidiii N.ltneath!
I i
)
In addition, licensees may specify more stringent cut-off levels. lidi6se caseshlis firesults 6f filWs6IdsniiigToins musFsheit-be reported for both levels l5 euch e.,eediOni W iudifsirindeMMsts need.bshonductedMW6M6[tiis.[duNiffMelRi66siUisiibd ~
calculated; i@5iliyM)?M2FddMWiippii6sbisWsissihisEM745dNis%ddyalidityj areJ2 The li subject to change by the NRC in response to industry experience and changes to the HHS Guidelines made by the Department of Health and Human Services as advances in technology, additional experience, or other considerations warrant sis:si]cisisiR" - ' ' ~
esbeteacee end ei,$eneg.3,j.jea l eve lL_
$YlWIOl6[kSCf#Uns0g tests}@nouges r**;._MIddM1I sarnejrug; cia _ssJnay be 4
Esifonsse.g E.n.ife.s
...ne.. eded..~t.o...,.w..
6 7
-e.s,)g n,.,ly.u.......@r.
e..
p 9,,-.9.-.,
,je.mp.g mo.y 9,g.,,
,,,. seduce...t.h. e. hffo6t.,?..o...,f po_s..s...i.b..l.e.. c...
s spegsams igga i gggg posits,.
,m y.,,,,. es esuUor ys
_he. t.,amm._ x
., m s
.s a..s..t..s...i.tyy~d...u...e.,~t, o..
amp.
o y
y structural. analogs 3 (iirttiose spiiaisissiisherowvalid~aihilv66Hi~riistEihK5f6iii~o6tsidsdississ'6de
$iiriWimisunoassay,techhNue[dspMntosferends.KnipjsssfjeMkiisbribbori me..di6.a.tior$6B 60ssiitib11tisAdateinliie:ah:appmsxiitidilutionannuiremastwoCassic4 Mss 6dran~ wsis?
a (f)(g) 8 Confirmatory Test."
(1) Specimens which test negative as a result of thle eeeend Q@NsMdW6rii6iy screening tssibiUs0 shelf-be reported as negative to the licensee and will not be subject to any further testing unless special processing of the specimen is desired because adulteration or dilution is suspected.
(2) Es6iiiPaZs fdifdiisidWJMM Ask semp6] identified as presumptively positive on the screening test performed by ali HHS certified laboratory ah llifdsi.l:be confirmed using gas chromatography / mass spectrometry (GC/MS) techniques at the cut-off values listed in this paragraph for each drug, andkat the cut-off values required by the licensee's unique program, where differences exist. All confirmations sheiMbe msds;by quantitative analysis.
Concentrations which exceed the linear region of the standard curve shalH,ndsfbe documented in the laboratory record as "greahr than highest standard curve value."
1 B-37
,e d
i e Confirmatory test cut-off level (ng/ml) a Marijuana metabolitel 15*
Cocaine metabolitet 150**
Opiates:
Morphine 300 Codeine 300 wrmw,m L T.
.... - Ir-"M h....
k Phencyclidine 25 i
Amphetamines:
Amphetamine 500 d
Methamphetamine 500 Alcohol" 0.04% BAC 2' Delta-9-tetrahydrocannabinol-9-cart >oxylic acid.
saaBenzoylocgonine.
- tiisiWRKANii6iiialsiraaiisiiiiinipiiiirsei5iiisTissivfii56
'hmonedino2.cophomie.
'ilpeniquenisusisdsulToontain iemphodiiiiheM5 EaneenmasonE2eo:iwat
" Percent!tiifiseight;%icofiiillrisFFeiiiiuhDi6sd insiim 6E:miinisd won gramiatisonnaiputsco
%[tioodygranudd(MNMgM or<twesh..
In addition, licensees may specify more stringent cut-off levels. iiiistuiiiiii'dsiiisii365 Riesults shelliiiGifbe reported for both levels in eat, een;.$U$iWsii6re, stringent fastf6iiisd tie 66niti[i[diilliiiisfMMyiEMi(^tiU@lf Misilfati6iii)HijAss@W (3) The analytic procedure for eenf.imeteri analysis of blood specimens voluntarily p ov,ided by individuals testing positive for alcohol on a breath test shelliiiGi{pe gas I
cnromatography enalysis.
I@iiilSj$(4)iOUINiiiii[Affil6Biiid53piilisillslfaiEEissidN6Aidil652iI6slysi4[shi33mlid 6i subject to change by the NRC in response to industry experience and changes to the HHS Guidelines made by the Department of Health and Human Services as advances in technology, additional experience, or other considerations warrant.sishfi~diiiiiidis]edd%ene; eube;e. eee end j
ether e,,neen;. en % ;;b.
1 (5) Cer.T.n..;;eri teeO fer c-T;;;; ehell lae:ede ; ;;e; fer 0-meneea./.me.T,h;ae (l4AfA) if the screen;ni, ;eet ie p.eeemp;.;; pe;;;.ie fer me.ph ne.
MYiiE6liiE553iisliiiiItTNMICfE8SI45iiG550lff5fMIisssi 66[Wsted f6dliisMleH@liensersf]Mh!apecdonlcdtede snusMMA$iniditionalMss he^meones%f tilshksmartsidisiinust niUrsportedWtimiffWIRO?
LatxuSNM)oitrel.
(g)St)
- Reporting Results.8 (1) The HHS-certified laboratory shall report test results to the licensee's Ltd;ee: Rei e vi ONieer M56 within 5 working days M6FynFAr6@ijii5iiiiiiiiiissfafter rec _eipt of the specimen by the laboratory. Before any test result is reported l(the results ofinrtrafs' creenin.gjests, confirmatory tests, crisiil! quality control data), itWiiji@llssliti6sheltiiGnpe reviewed and the test cert.ified as an accurate report by the responsible individual at the laboratory. The report shalM[tIHe specimen number assigned by the licenseefsiWisiN6EliodisMtif
)dentify the substances tested for, whether positive or negatived the cut-off each B-38
i hhariiinnafM$iilsihifsieljilii~gisisisti and the drug testing laboratory specimen identification number. Tre res#; (pee;; se end ne;,e;;se) kr ell epee,,cas es,T,;;ted ei the aae ;;ae M tre seremry ete;; te reper:ed t,eek te ite !.td;e.: Re.;;;c O'f;eer e; the ee,Te dTe #,en penL.
(2) The HHS-certified laboratory and any licensee testing facility shall report as negative all specimens, except suspect specirnens being analyzed under special processing, which are negative on the ;cN h$ test or negative on the confirmatory test. Specimens testing positive on the confirmatory analysis shelHiiis(be reported positive for a specific substance.
Except as provided in $26.24(d), presump6 positive results of prelimmarysissinihitesting at the licensee's testing facility will not be rep,.;.ted to licensee management.9WMRO'istaff msy EEIA55EIWaldinisissiliis"issiIsiUdssiisiis[Msiiiiiht @sjMult$jhdl scheduling intervimodorAideck (3) The MedseeHteviewefficer WRO. may routinely obtain from the HHS-certified laboratory, and.the laboratory shel@istjprovide, quantitation of test results. The Medical Re.tv. 0%eer MRO may only disclose quantitation of test results for an individual to licensee management-if required in an appeals process, or to the individual under the provisions of
$26:29@ eeeden 0.2. (This does not preclude the provision of program performance data under the provisions of 494FR $ 26.71(d).) Quantitation of negative tests for urine specimens shall not be disclosed, er. cept where deemed appropriate by the !.td;ee: Re.tw 0% eor Ml30 for proper disposition of the results of tests of suspect specimens. Alcohol quantitation for a blood specimen shelH6Gst?be provided to licensee management with the ided;ee Revb w ^.,'f;cere MRafs evaluation.
(4) The laboratory may transmit results to the ided;s: Revke. 0%eer MRO by various electronic means (e.g., teleprinters, facsimile, or computer) in a manner designed to ensure confidentiality of the information. Results may not be provided verbally by telephone from HHS-certified laboratory personnel to the f.kd;e. Revbw 0%e.r MRO. The HHS-certified laboratory must ensure the security of the data transmission and limit access to any data transmission, storage, and retrieval system.
{
(5) The laboratory shallistilsWhiil inil?%~W656srolysiWilisi[hsiisifsend only to 0
the 7.kd:s: Revb 0%eer MRO m-certified trei5copyiss of the original ce;a-ef-cuebdy 66stody-IsidEsiilrol form E6ilWeisfseigiisi@liiWessibiMMMMM56siiiseRspic61 processillidKsispect specimagsf9ieberesnusthsigned by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the validity of the test reports end e;; ded b J/,eh et,ell t.e e ---~ ^ ef tre %e; re eri.!
GitxxiiiidsssiGi otMapper* fsiGilliWdisssi6is~cdiinish@leM[
(ND(a)
~
(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. la;del C75 test data from the licensee's testing facility and the HHS-certified laboratory, and confirmation data from HHS-certified laboratories! ehe:: @ii(be included for test results reported within that month. Normally this summary sheltinUsilbe forwarded from HHS-certified laboratories by registered or certified mail and from the licensee's testing facility not more than 14 calendar days after the end of the month covered by the summary. The summary shelHiUist"contain the following information:
(i) la;0e: EM@ Testing:
(A) Number of specimens received; (B) Number of specimens reported out; and (C) Number of specimens screened positive for:
NfMarijuana metabolites (2); Cocaine metabolites) i (3): Opiate metabolitest (4);Phencyclidinej
($l Amphetamines [liihst lS) Alcohol]
i B-39
=.
j i
I (ii)
Confinnatory Testingi (A) Number of specimens received for confirmation; (B) Number of specimens confirmed positive for:.
MjMarijuana metaboliteR -
$ Cocaine metaboliteR
@lorphine, codeine!
i
$Phencyclidine WAmphetamine(p;
$$4sthamphetamines5Ed
[77Alcoholl 1
(7) The statistics shall be presented for both the cut-off levels in these guidelines and any more stringent cut-off levels which licensees may specify. The HHS-certified laboratory and the licensee's testing facility shall make available quantitative results for all samples tested.when requested by the NRC or the licensee for which the laboratory is performing drug testing services.
(8) Unless otherwise instructed by the licensee in writing, all records pertaining to a given urine or blood specimen shall be retained by the HHS-certified drug testing laboratory and the licensee's testing facility for a minimum of 2 years.
E-:i;ae %[Uurine specimens $ge.8
~(
- Long-Term Stora Long-term frozen storage (-20' C or less) ensures that sS sihiitibandsliiniMiiiiiiiiijisilgtQifijEiijdsjillifs~will be available i
for any necessary retest during administrative or disciplinary proceedings. Unless otherwise authorized in writing by the licensee, HHS-certified laboratories shall retain and place in properly secured long-term frozen storage for a minimum of 1 year all specimens BiE)isisiTsiij confirmed positive [ji@liENiiihW"4Neii?iiiiuij@igiisil Within this 1-year period) a licensee or the NRC may request the laboratory to retain the specimen for an additional period of timerbert ifM no such request is received, the laboratory may discard the specimen after the end of 1 year, e,=.p; re; raMiilaboratory WiniQtall be reg lied te maintain any specimens under legal challenge for an indefinite period. Any split nr.i:: 1~PT~^Zretained by the licensee shal@$iiIin[be transferred into long-term _sto_ rage upon determination by the '. tie: Re;;w Officer $$4Q that the specimen has a lstakelgrylconfirmed positive test.
(i)$ 8 Retesting Specimens.* Because some analytes deteriorate or are lost during freezing and/or storage, quantitabon for a retest is not subject to a specific cut-off requirement but must pro or metabolite.9%i%is iiiiiibi$4(jde da,ta sufficient to confirm the resence of th W
WiiiiisWisi"adi
- iiiniidiil iseini#gifueilishissNhu Manos #smesninnistnesanina i
(t)94 8 Split Oe.T.p.4%egisiiML5 Urine s discretion, into two parts at the collection site lijg' pecimens may be split, at the licensee'si ue'niNisa'liiscutasiRM,2NMrg, One half 55ij of :-d. e r..Mee Mfgi5iliis'lp (hereafter called tre e:4efadgiipyjegiecimen) et.el@ij be analyzed by the licensee's testing facility or the HHS-certified laboratory for the licensee's purposes as described in this ap called the splitW[M)pendix. The other halffiB of the ee.r.p;e Tid (hereafter may be withheld from transfer to the laboratory, sealed, and stored in a secure manr=r by the licensee until (jiisiliijillgi@[the #qe:4 7 7Ejilisisiid has been ~e~siRiiiiLMGii~jiWiiiiip"sjiisiiiiiiiMe' ermined to be negative Mep;cCaiiy c
t l
NiidiiliiiiMil$gjogging$iillightijpe. cimiERMJiiWiI.ilistisied@fer er.;.: the g
g,
_ g" has been
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a e=. u =a ;4=; ta==d r+.;= =a e+=
i e...pe ir, e;ere~e.Taj be -i:;..i;d. l'24 7,fesenes$isiiilshNiliiId%$5iI%ionses%
z ' O C pe, 0 ; by eei.T.i.ia;eri;ee;;i.s, Car.,e; the tested individuaFs uestfSiiWi N_
_~i% MMissstedMM%ise!Nass@yditjspeceri i
forwarded Efs..
~~ ^^wgulosellittiislim6midsgl. tThe split semple mey-specimen must:be cam! _.
hifiii6iisiiiiiiiiiii#iiH~Miiiss]iiiiiilGlijiD4onds9Mffsini?
MINisibilpshelMiS)foloudag orHhetDiday intyidjempiastjto another HHS-certified laboratory that did not test tra e:4ediutmeryspiiphisii The chain-of-custody and testing procedures to B-40
1, 4
,1
-cm which the split e ra s subj.ect:sheltimsel. be the same as those used to test the WlUisdlin8bhM[A :. La.
j li.;;;e: el;que; '7 spioiistiniand sheltinniffneet the standards for retesting specimensEW.]
i
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9tejagetitjisisiflilifi~cNedi~iiUMIdiiEifDiiiiiisissii60t simusijiifoWdsjati g
sunicieWbanlisisseEiemeanoeWihsAnskmasseisms&=i-Whavious j
inlanne8on46eebenpengegni2.7(i)S]). The quantitative results of eay eeeend ee;;ng preceas j
instini$(tlip$iRiiiecimes'shall be made available to the.".tj;ee; "e.t.c ZeerPC and to
}
the individual tested. EbecepfisIs"~noisillii%ilisi6llonhalliid6Ei~'"Ef5HiiGis "NiN6ElitsWMapacimens!sheBlissliiMappliceldsid3hliiNecim$nsdif$sYse$sFil61 a
sulf 6ftiis tesforesiipsf;ipebimesi fan 6WisconssfidEissbetonenterthsaisait aposted faissii primary i
specimenWismoiesisaisisesWais)isputspecimenfe:esiressun,5asiirasts9egar sidiaryspecimen
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i breeenos#4beenoniit sidWinstebogadirimas if ideu enoesitsubversi6n; t
sisiiisiiteinermisikant sifiinnesion1ioiseloistirminisuilherMisisisties0Rs shsGld tii[v&NisifsiFs i
FFDjiolicy viola 80siMhe; licenses mustiinvesd$iiteisiliiconec6se actiorisijFappropriate~ih l
responseA6!airii;mpediMMtc.teilsii]lcyteconR5 qMiinsctedji$18(ff6fAppendiiW (k)ll)" Subcontracting." HHS-certified laboratories shall not subcontract and shall perform j
all work with their own personnel and equipment unless otherwise authorized by the licensee.
The laboratory must be capable of Ri'ema:ng testing of the five classes of drugs (marijuana, j
cocaine, opiates, phencyclidine, and amphetamines) and of whole blood and confirmatory
{
GC/MS methods specified in these guidelines.
l (t)(hi)" Laboratory Facilities."
l (1) HHS-certified laboratories shall comply with applicable provisions of any State i
licensure requirements.
j (2) HHS-certified laboratories shelFiiisiiiihave the capability, at the same laboratory
{
premises, of performing imtvet-siirisihisig~Wisjonistisseldiitests for each drug and drug metabolite for which service is offered, er.d for pr'.ca.;ag een',ca.e;ery :ee:e fer ;;eche: end for l
each dre end drag a,e;ehe::;e fer wh;eh eers;ee e e"eredIissifWs6siljeif66idssie bl6od]foi 5866661[
lilACj Any licensee testing facilities shelfisisi have the capability, at the same premises, of performing Epsuliis@slidiffissisliip'iliiidn327(s)[ssisj imtieFscreening tests for each drug and drug metabolite for which testing is conducted. Breath tests for alcohol may be performed at the collection site.
i (m)(n)81nspectionsissi@isiBis.2 The NRC and any licensee 4;-,g isoisi an HHS-l certified laboratory shelFreserves the right to inspect bijsili[the laboratory at any time.
j Licensee contracts with HHS-certified laboratories for drug testing and~ iiielfiss*bf^iishioidbl66d j
f66alcoholj66EIsistjlAC) een',n..e;.ry tee..g, as well as contracts for collection site services, sheliliisiilpermit the NRC and the licensee to conduct unannounced inspectionslii6d~asiditisiid iiih6imirf58]isilissiWin75iiillil66iisiiirsiiii6siissiiisillifrialisisidiiinisliiFiiiti6idindieudits!
ucenses caninecessimi:sess.cersnediaboresaries austeli6:provissi siirmenneisrid me:NRC
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iiiBiitiisTallEld6[ctitairicopiselbf'aiiigf docsinente, including gewiewsliiiinilnspechons piertainirido esaletmessoire esisscemon eyaessisEd ersitesherydeniidhetsiissibiinsededWassoni smi; the letweesoriaspesaiiinineliinssiansiinitiisimieneinsemianassvnnpedFnistaisiseboraiory sider 4
f inui jarecedmee sneet appRcelde seguirennents.*Annusd Goenseelnepectionsland audits bf HHSs l
BiedlRed 8=Waha~asediiii68 ikqsEcide asiis insgiiscendiiilliissniset sociifMHS Tcertification insn%dijiityksisiioenime s. views *esi HHSheiE8cauch inspeidian socordiss ascosteir(R$jispsicojshedMaleMSises91icalieninspec6eggin addition, pr;er ;e in L
j icielthe award of a contract, the licensee shall carry out pre-award inspections and evaluation of the 4
l procedural aspects of the laboratogs drug testing operation. (isiletS certilisifs fiboHId6ffi6iidi t
iti'siiitbliiidiiin$iiTaifiiililian ph ir tallisheseFperabisiHifisissocBesalphise(iihtHHS-certified labeteApr$9ist fiss;beein audlisil l@MnodgerMICliosasee ttowinitislsumidnigpenel arid 'cist4 I
hlflisbisiTt4licassee:ahatlauditjikseedy.co4ReacletiMHS4estlSed letmistoitwithisihree i
spiiWihi$The NRC shelffeservei the right to inspect a licensee's testing facility at any time.
i (n)(c)" Documentation.8 HHS-certified laboratories and the licensee's testing facility shall j
maintain and make available for at least 2 years documentation of all aspects of the testing j
process. This 2-year period may be extended upon written notification by the NRC or by any
(
licensee for which laboratory services are being provided. The required documentation shall j
include personnel files on all individuals authorized to have access to specimens; I;
i B-41 4
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chain-of-custody documents; quality assurance / quality control records; procedure manuals; all test data (including calibration curves and any calculations used in determining test results);
i i
reports; performance records on performance testing; performance on certification inspections;.
and hard copies of computer-generated data. The HHS-certified laboratory and the licensee's testing facility shall be required to maintain documents for any specimen under legal challenge for an indefinite period.
(e)@ 8 Additional Requirements for HHS-Certified Laboratories and Licenseeis! Testing Facilities."
I (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 and controls, calibration procedures, derivation of results, linearity of methods, sensitivity of the 4
1 methods, cutbff values, mechanisms for reporting results, controls, criteria for unacceptable specimens and results, remedial actions to be taken when the test systems are outside of 2
acceptable limits, reagents and expiration dates, and references. Copies of all pmcedures and dates on which they are in effect sheltisiiilbe maintained as part of the manual. Eiic' tiHHS2 1
UidlNiil%Uli'ENIsliTnTdiSifiINnsiliiffnicediare.nestuifasa '~e~ssidIintilTat Asiast 2 s
~
years albeERNMienget1Wedercontractisfiin)ptClicensasiWiist?apacimensl.fddrugsiEacii licensee;eistiaindads ensite teining radan$JUntilMM)((Ui$eryonducting;itissistaisiiikapijetiisisteerpmoediseTinanual'abi
~
i j
jiMieelind)(.apecimen{bf3 minis [ fob $ rugs [ '"
j Superseded material must be retained for atMihree years.
(2)" Standards and controls." HHS-certified laboratory standards siiid?siistiois'shall be i
prepared with pure drug standards which are property labeled as to content and concentration.
The standards ind"66ntsni shelf-iHUiiibe labeled with the following dates: when received; when prepared or openeik when placed in service; and expiration date. FAN ~sfi5diH3ifisd~655tr61s l
UiisdliiEsiiWiWiniIsi6otisi"lisiiiiiii"a~ihiliiiiif4~uipmenfiisiligidG$iirsiiiint lised;istlicensees'l testing facilities.Joshonduding scesening. jests.fnustWcurrenijahdjalidjodheii6urpose..
4 i
(3) Instruments and equipment.
(i) Volumetric pipettes and measuring devices shall be certified for accuracy or be i
checked by gravimetric, colorimetric, or other verification procedure. Automatic pipettes and dilutors shall be checked for accuracy and reproducibility before being placed in service and i
checked periodically thereafter.
j (ii) Alcohol breath analysis equipment shelf @)e an evidential-grade breath alcohol analysis device of a brand and model that conforms to National Highway Traffic Safety I
Administration (NHTSA)siWM(49 FR 48855[rGKi@WMMddi8fR38ZO5j standards Siipisiniisi37M99for
-/sisissilid) and to any applicable State statutes.
Calibration uhits used iscalibrateilcohol'issallisisilpils~eiiuip~nissi~n~~isOsiiiilil Elisisd:shdjtyisi u
9diilbonicim lOlHTSA standands[(62 FR33416fAugust113,il9973iiissjsubsequently amended)
EridE$ipappicable State statutss:srid]hiiist'tiipsuitableMinditinl[#shuloohol testang Fiquini(iientsApait2sj (iii) There shall be written procedures for instrument set-up and normal operation, a schedule for checking critical operating characteristics for all instruments, tolerance limits for acceptable function checks, and instructions for major troubleshooting and repair. Records shall be available on preventive maintenance.
(4) " Remedial actions." There shall be written procedures for the actions to be taken when systems are out of acceptable limits or errors are detected. There shall be documentation that these procedures are followed and that all necessary corrective actions are taken. There shall also be in place systems to verify all stages of testing and reporting and documentation that these procedures are followed.
(5) 8 Personnel available to testify at proceedings 8 The licensee's testing facility and HHS-certified laboratory shall have qualified personnel available to testify in an administrative or disciplinary proceeding against an individual when that proceeding is based on positive breath analysis or urinalysis results reported by the licensee's testing facility or the HHS-certified laboratory.
B-42
MRiililitishDs.~4i6iiiiiiilbif1iih~aB~nsisiiiiiflil6lsnTy eliii6Hih5iTaillHT56i~riisss's e
MR6 inst sisiitsiirconsnued aiaWpoesneal conmat er inesioitwariseWiinanciapienefit di i
himl@lanenss6idsXssecenasRO; 2.8 Quality Assurance and Quality Control.
- (a) 5 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] but not limited tol specimen acquisition, chain-lof-l custody, security, reporting of results, inittel i
56issiiiingand confirmatory testing, and validation of analytical procedures. Quality assurance procedures shelffnEi(be designed, implemented, and reviewed to monitor the conduct of each i
step of the process of testing for drugs.
(b) " Licensee's Testing Facility Quality Control Requirements for lal:;e; S66iiihihdiTests."
Because all EESfpositive pie ;ra;a.ry 9"T(iciliffi6iii~ilsitests for drugs are j
e forwarded to an HHS-certified laboratory for screening and confirmatory testing when appropriate, the NRC does not require licensees to assess their testing facility'sisit false positive rates for drugs. To ensure that the rate of false negative tests,insiinjiiCPW5iiii is kept to the minimum that the immunoassay technology supports, licensees s,iissijEi(a sampling of specimen hallprocesejo blind performance test specimens and submit l negative from every test run to the HHS-certified laboratory. 7tas7hesiMiijfssissisd;tiEM6iiii'tifsd latniiii6iWiiGifOsiWiislissidjiihdisjijih3prisii~csiksciiirE25ic6cni'takenK:n edd;;;ea,Ithe manufacturer-required performance tests of the breath analysis equipment used by the licensee ehell 5iGi(be conducted as set forth in the manufacturer's specifications.
(c) 8 Laboratory Quality Control Requirements for lal;;e; C~MTests at HHS-Certified Laboratories."
(1) Each analytical run of specimens to be screened sheffisGiiinclude:
(i)(4) Urine specimens certified to contain no drug; (ii)(e) Urine specimens fortified with known standards; and (iii)(3) Positive controls with the drug or metabolite at or near the threshold (cut-off).
ln addition, with each batch of a,p;ee[spisilsiiiii, a sufficient number of standards (2);'be included to ensure and document the linearity of the assay method ov shelf-Ein.st concentration area of the cut-off. After acceptable values are obtained for the known standards, those values will be used to calculate semplesiiiiiiiiiiijdsta. Implementation of procedures to ensure that carryover does not contaminate the testing of an individual's specimen shall1 mss [be documented. A minimum of 10 percent of all test niiisf be quality control specimens. Laboratory quality control-semples'ijissliishs, prepared from spiked urine semplee siiisihisisilof determined concentration, sheff1nhet be included in the run and should minimum of at least one eerap;elspe(m]n, shalHnustpe the laboratory's own e
eeraplee[igiosisiini (d) " Laboratory Quality Control Requirements for Confirmation Tests.n Each analytical run of specimens to be confirmed shallinclude:
(1) Urine specimens certified to contain no drug; (2) Urine specimens fortified with known standards; and (3) Positive controls with the drug or metabolite at or near the threshold (cut-off).
The linearity and precision of the method shall be periodically documented.
implementation of procedures to ensure that canyover does not contaminate the testing of an i
individual's specimen shall also be documented.
(e) 8 Licensee Blind Performance Test Procedures."
(1) Licensees shall purd.;;e 2, era;sl:ee;,ng eer/,we sa;y frein ebere er;ee cer;;f.ed by Ollll0 er e OllllO-re'~w ; ed ar;;T.e;;en pre,en la ecerdance eth the llll0 Ouidel nee."6hly a
v tg
-~
i finieve_esina 6meiidemmunoassipsidocassnisd a
B-43
fa. M,isiliMdEflEiE5NIffMIiWifisifi5meng3MiliisiiihElsilelijiMi[sisiii Leberaterf u
._5 7---'6.pp%. m.._.m.5 _
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,#.5 gig L.I y a pedernienee le e.copered ;;h p.; end re'.rease ;ebe,e;edee.
(2) During the initial 90-day period of any r.;' dr.g ;es...., pr.,,en@fS2Disit(in}lHS2 Eiirilfliiff.lili6iiili@iiMiiifsiW~iisiildih74ffiiljeggedfziniiitii), each liceinsee shall submii f
blind performance test specimens to each llll%; Zed %$ laboratory ~~lt een;..e;e within the amount of at least 50-20l percent of the total number of eea?;ee F.W "Isubmitted (up to a 4
maximum of 500 a.plee!$Ws~issiiliisiis) end ther;;7e, ;i3(iblirulpericissisiiciliii 1
M~MhlCIEiiiiiflii?55mieG00000iiilRiiiW51Riey3Nisiodja minimum ofisspercent of all ke"~
abW_.eas_lisgreaterT r to a maximum of-25025)iiiM_0)l.ind pestoiiisiEiili_siFaig'i_iii iiQ x_
a fie! submitted per quarter. Limoneses shoukimskelariattempt.to
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'uniinit4Gildperfomainos. sittspechneni~dising....
AlklippadotissiGiiissaunftC s
is thereeneweseuenogastboomaisonds:seunibtenissierte guiinawdoikiiiieciaisss; (3) Approximately 8ef0jpercent of the blind performance test eerap;ee ehe:: 55,;Wiiris mustbe blank (i.e., certified to contain no drug) and the remaining semples-shalHijiscimeni inus(be positive for one or more drugs per semp6'lin a distribution such is that all the drugs to be ;ee;ed $idiiittici@i(85Eiiii3ETeijiiiili@ere included in approximately equal frequencies of challenge. The positive e.a+;e; ehe:: "S~duikifbe spiked only with those drugs forwhich the licensee is testing. In"5dibilii i
~isOisTsisisi@ili' elyMisiiaWeiillgulati$isD@h@etiShahmesii203sil)80)ercent'o m
l p
56raninW:cuestvalues===msWhhanass2MarsiisieppendwfarMastasseiicut:stf kahiesMwgiliiillicenseiMehallamiiidliiiiListumato&Kisteltiiindensinsne ispecimid yalidity3 ski perfonh sp[ecied proogainlNssjaquisatigsochonMS)MinDpjumshx.
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unesue'.c;; gjedeanence ;eeCag reed;, er.d beeed sa th:e laseengr,.Cen, Theflisiiisisisefshsil fiissidjsis"s[ny7%"Sissis*EFir""T~TpiiinishisssiiniiE54~eisidfriena voirformance testingjiiMtesting Oflectusi ebeclissinsMWuis@(di6tocessindW5hpesilijind IWIRO ~
res; weges:iiisaasasietheresorsbOnsbers:!Wbtc6ialdr AcctRf$6hths*stegritishhi testi6h jihinessSThiiiiWestigelion must determiisselevant tihtilidipdenefithE]c6tMaise(s)Lof
@estin0WprocessM[atiert posshid&Tliii@censeinMthe laboratory shall take action to a
correct the cause(it) of EngeN0rs;oCthe unsatisfactory performance ;ee; reedt)istisihis]sithsh thsl[6shii61 A record shelHnGelbe made shiGifilhuifMhi@isNiiiift]iifthiiiiyeais?of the
~
investigative findings and the corrective action taker, by the ebere; if, and[minogejijipinistdil that record sheihnuiifbe dated and signed by the individuals responsible for the day-to-day management and operation of the HHS-certified laboratory. Then-Tthe licensee shall send the documentisiitiNiliito the NRC es-a report of 55fthe uneet 'ee;;rgpei'ecnence ;eet;ng lncident si$i]iiisilisilaker[6fpiiissiId;within 30 daysfl{cisijilill5i@ttiiiinvistisiitidh The NRC shall ensure notification of the finding to OHHS.
(6)(2) Should a false positive error occur on a blind performance test specimen bi[6ny ri@dliii"sjiecidiiHE.end ;he ener le de;;.ra;ned ;e be sa eda.:n:.... se ener (c;edee:, eerap e a,Lep, etc.), the licensee shall promptly notify the NRC. The licensees shall require the laboratory to take corrective action to minimize the occurrence of the particular error in the future-andrif24f there is reason to believe the error could have been systematic, the licensee may also require review and reanalysis of previously run specimens.
gJ) Should a false positive error ecGr en e bllad pedeanence ;ee; epes;rnen end the ener le y,(determined to be eiechnical or methodologicaFener, the licensee shall instruct the laboratory to submit to themiljail quality control data from the batch of specimens which included theliiiiif;talse positive specimen. In addition, the licensee shall require the laboratory to retest all specimens analyzed positive for that drug or metabolite from the time of final resolution of the error back to the time of the last satisfactory performance test cycle. This retesting shelll555fbe i
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-stte 1
66ilii review of the laboratory which may be conducted unannounced during any hours of l
operation of the laboratory. Based on information provided by the NRC, OHHS has the option of B-44
o h
revoking or suspending the laboratory's certification or recommending that no further action be taken if the case is one of less serious error in which corrective action has already been taken, thus reasonably assuring that the error will not occur again.
2.9 Reporting and Review of Results (a)" Medical Review Officer shall review results." An essential part of the-E licensee's testing programs is the final review of results. A lati6hE6iy!66hliH55d positive tes't' result does not automatically identify a nuclear power plant 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 attemate medical explanations is essential to the review of results. This review ehell 5j5iijbe performed by the !.k3:ce: Re.k 05eer MRO prbr te tisj5Ri3he transmission of results to licensee management officials.
(b) " Medical Review Officer-qualifications and responsibilities." The id;dkel Reyk..
Officer $dRO shall be a licensed physician with knowledge of substance abu fe MRO-end may be a licensee or contract employee. H6iiisisiiltfei:MRd~shillji6iVeissism EmpiEf36ii'WI6@i6iiii351 idIIiEDIli66iiscriMil[26ntracted operatch6DinWalfs tesung1scietywhoii?dnii* testing resists sis:MROWiebiousindWhiiisioensee/AdditisiellySne MRoisMEMWorivshanancialbeneStti/%st&RiswiW;assioisehE%g3shtihg W5cens4dMiiiinjiiWMe latsnateifM6ssiisdiating tabnityopeniitirie:Bontra suel@ sales
- 5iltihahii[constrsediiiWhoeschalconnictMinierest&The role of the f.td;u.l Revkas 05eer MRO is to review and interpretged.ve test results obtained through the licensee's testing programliBdis?idissifyevidenceFssissisidif6OhiinliisF hi6esis%TiWMRoisisis6 resp 6iiiltiesWldentilingissdes =A~WudeiWhenec^iTp~inut teshnRspecimens75 nor a#isiMid4d:assisanomanagemsnOnlih6)lannirufuh@verslohthsfoversilymprogram in canying out this responsibility, the ided;e Revk.; 05eer MRO shall examine attemate medical explanations for any li66Hii6rfpiijiH55iid] positive test result (this does not include confirmation of blood alcohol levels obtained through the use of a breath alcohol analysis device). This action could include conducting a medical interview with the individual, review of the individual's medical history, or review of any other relevant biomedical factors. The " ^ ' ^"---
NIRD shall review all medical records made available by the tested individual when a liS6ist6iy confirmed positive test could have resulted from legally prescribed medication. The Medteel Revkv. O'eer RARQ shall not consider the results of tests that are not obtained or processed in accordance with theee Ou;de ;r.ee)tiis[sjiisdni, although he or she may consider the results of tests on split semp6]in making his or her determination, as long as those split serr.pk; MMhave been stored and tested in accordance with the procedures described in these Ou;deCr.ee[thiffsiIpisidiiil (c 8&nididii[Revleu(Olli6siisisiifi6iiiis4RreeJ.se Test Reeslte (1 ;rr;er to lMLivmaking a final decision to verify a laboratoiy[c[o$ poli 693iolatid nfirmed; positive test result, bi'Isthijfd66GNenc(16sCiiipciUld[66HiilisiiIIREt{holl6fyiolationjsMatteni@isid ishisisiiidon)j the !.td;s.l Revb O",wr NIRO shall give the individual an opportunity to discuss the test result 6[di%issiPd6UiniN6isiwith him or her. Following verification of a liS6ifii6ii c
Esslirmes(positive fest"resuEMcGisi]66EGrrencejasMiiEstis5 MFD l56e69, the Medreal Revtew-Officer hEJt0 shall, as provided in the licensee's policy, hM'M$ notify the applicable employee assistance program and the licensee's management official em owered to recommend g.ke administrative action or t,he official's desi nated agent
~
- UsEnishind or ta sg-g-
- g aeEiHElsassoniora@poscy violatior(wHhout havin0 dew 1hs;testissuRKother oodissncidinice@leithiiiindividsel iri thiis Dniecinsifmstancesi g,,g g
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065fiEEsd'pUsfitiiO355WsulfdridsH6slKsGtiniifd6isi@ssfi6p~pi66issE6f!6thsisiii.c..tNiipth.at i o g
16is_iGi.de(ii0$(soonsee supresentativiitIiiiiiiNGMdiFdsdi"a~52i?d66Gisshiid"d asdri Wstructed;tsriifk&sFWhosincGhiiiMROIAbidWthshfnifsyshussysM since:tliddits:1hiifiddindualMissi=~a===6sycontactedWthFucensee repssenistius!
siiABills(dM) Mans:@MRO.msihadijiidetesnhaHonWiii%ibHcy violation ~undejW 3
3 A19 ndiM(iii)$1iniEendividuelasiiiiiresent tdMMRCfinfonhs06h docinentinottist,seri6us;mesiissziniur' RottuiiFbircumistanbeiisnavdicntAyj6!sshtsa'HisiBEher y
i frsh[being WWens MROM1icensee sapresentatisiE6r.ftsincontsctisWthe;MRoliria ~
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timely mananimTenii:MRO/bhWhosisl6f nifidemia6cnfibiileopen%sjioceduisifoi determinahasiWFFD)hhoidifittii(initiaOfsei$Wistion base 6riadjiidstidh i
thiidssui@ sided)MRO)sa thformationgo j
(d)" Verification for o Before the Medical Review Officer verifies a is6, plates; revk fer pree.IIW;en medket;en.8 6iii6iyjconfirmed positive result liiij}i61sti66l6ffl(($6liify]and the licensee tai es action for opiates, he or she shall determine that there is leasonatil6}shd j
EGi6iiiijclinical evidence--in addition to the urine test-of unauthorized use of any opium, opiate, or opium derivative (e.g,IiiniiH66KsEishi%ilfMiliiidyssti66Wl663"6Fr5sd morphine / codeine). Clinical signs of abuse include recent needle tracks orIssi7ssUiisthat IUUiUdi5g'N$iissiipti0n nissficatiohs30ntaining.6$iaIss$5MAMMtk6fiiS6Albighsl6@$Ufe als6]hcludelbutMj(hbillimitediO,%beh.aviora,l and psyc,hologica,l sig.ns of acute opiate
-, - -.n n
intoxication or withdrawalt,orgdmissnonlotpon-p._ ibed op stetuse. This requirement does not rescr a
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apply if the GC/MS confirmation testing for opiates confirms the presence of 6-AMfserkiii6s EM6sMbijjissfa66 tits]sF66fRiisF6th Gss;nencecety:merph:ne. rer eEMsgiEt are i
commen y preew;,ed er commenly indsded ln ever-the-cesi,ter preparetiens (e.g.,
bercedk epl nee in the ';i. =-e, berblturetee in the secend) end that are 'k'ed in the lkensee's
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is cFn;;cd evkene; ln eddltka te the vr;ne tet ef unestherked see of eny of these subetences s
va u gwu wus s v umu.w e.
l isti615(Je) 8 Reanalysis authorized." Should any question arise as to the accuracy or valid i
ory;c5hfin{siMipositive test result, only the !.td;;.IUl Re.tve OZeer IUIRd is authorized to order a reanalysis of the original eempk hiin6isiiHIand such i6ssi retests are authorized only at 4
laboratories certified by OHHS. The f.tdkel Revk.c 05cer MRO shall authorize a reanalysis of the original aliquot on timely request (i[silablisl1isd,W, n}6.s?lic,enses[by_the, individual test,ed,. and shall also authorize an analysis of any eemple p_wdgecamen stored by orfor;the l.icensee under thiiW6Yisi66{5fJMM6flthissWdd (f)"Results consistent with responsible substance use." If the f.tdkel Rcvk.y Offker 3
MRO determines that there is a legitimate medical explanation for the niA@id6hfihhsd positive test result) and that URuse of the substance identified through testing @asjin the manner and at the dosage prescribed!s5dWiiihiisUiG does not reflect a lack of reliability emHs d
calely 'e creet en-the jeb ;mpdiment, Etrustworthidb~ss[thsnMhiiM6[bearililyi61st.166T6f li6s6iiissjiblisy8Tthe f.td;ee Revkvc 05cer MRO shall report the test result to the licensee as negadve.$The'MRDTafisilfGrtner FaldiElb7e iisiblfilindWHEN6si~iUIpisiisii66I6?dslehEisel
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i dibeiiris5s%sterstialMtsipubhc heintthirsilsafetyRthsindividusibelaDnpaired en outsfr66s his?sutistanc(6i[fibru;thednedical' onditionJIf ths MRO?determinssithafsub6Xrislyeaistslhslof c
WshiitW'aiiMi6iid?derminatidRaneiR (1)?occasionsMeninedicalESW"5MfisssiiiiZisTdsli5sairiS205KGsibs 6.65a5. 6ded include!6stWset.linsiisa inntnFfollowi5g:
s y
g;ggy i
Siis.~.its. impaindehtisriduisicouldexisissa dr bedWs12;.9(f)l
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g (iin:Before makiridretum-to2stirecommeridati6HsisGtissijash0Es5iiToiksts:HsnbVal 4{
fr6ii@uti;irgsb66idancd#itK326M(bE6iWaicensisXfdnsis;f6@Wp61icW i
B-46
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a O
M8iliis~abhMWiradsd 554s56ftidiis6ess wheriMEatio6"oldained SUisUint viosasions%$26.27(alst;dsMghistoryMsMidslibuseRapoordidsi6($tnesshfoi-dUtj
- sand (i)EmilissiyiirsiulisuiRTisiiiiiiissliii~enissisissMiiisiinsit trM4stnutscensed phyaidan w asRO detennineithet thiiisTuihiithii;66ii616iiiiid dwidsH6 eda:FFD;)olicy dednuorisis:ssignificant basis isFcon6Em^tnat MmdividualjrniP%i impased whilisriduip7#sen hsbifidui shaNl report Skiesult'Mhodativs]
(ilyif nieteissneest physiciaa&MRo;detenni6es siist thereWnst;c6561sisiiEWiaiiE6Fbf a FFDji68cpwielat;on;but Amt theseVEsigniEcont basislofconcom'that thiindividual hisy be
~
' npared widsWMMsiiiWiluishsE report NMiiihot 5ATFFD? poli 6i violationMii@6eisidO(Underishicdithiindntiduefnisphstlist 6@0edisefeIyankhompeten a
a perform ed== Seceuiisthese moults should not oormauteTidolabonlof ne: ascenses'sLfFD poliefkshiiNRC ruli2punuive actions under thiniuse should: hot nutaken based upontiis results, However@Hoensedphysicia!n,adRO7ar{thellicenseemanagementgsersonnel3di6"ars empownsed to take appalpdate mediens:shmWJnitiate acGons;to ensure that 'any r==$ limiting condialsh' aloes &sepresentTahreatEmotpleasWbublic heaW(and safetisWhsn_ deemed appopriateMiinallethiaiale6;ts6etened#tieJAej (g)(h) " Result scientifically insufficient." Additionally, the !.i;d;s: Rev eve Ofncer MRO.,
based on review of inspection reports, quality control data, multiple ee,T,p;eslspiicsieni, and other pertinent results, may determine that the result is scientifically insufficient for further action and declare the test specimen negative. In this situation, the !.i;dial Rev!;.i O'0cer MRO may request reanalysis of the original semple 1igieciNian]befor, making this decision. (The Medteel nev: eve Of5sr A4RO may request that reanalysis be performed by the same laboratory; or-that
)
an aliquot of the original specimen be sent for reanalysis to an attemate laboratory which is certified in 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 !.ted;ee; Gev:;.i Officer MRO 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, tofrovide specific consultation as required by the licensee. The licensee shall maintain @sininimur(ottiiiree' ysifs! 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 information in sweh ihsss reports.
Subpart C-Employee Protection 3.1 Protection of Employee Records Licensee contracts with HHS certified laboratories and procedures for the licensee's testing fac!!ity shall require that test records be maintained in confidence, as provided in 10 CIR S 26.29. Records shall be maintained and used with the highest regard for individual privacy.
3.2 lad vldee! Acwee ;; Test ead L.bere:ery O.d;f;s;;ea Reeslte.
Any ind;vldee! te le the eeyec; ef e drug er ;;whe: ee; ender ;h e ped ehel;, upea r;;;en repet, heve eGwee ;) eny reside si 1,g te hle er her tee;e, ead eay reserde re:eeng to the rewlte of en, relesen;lebeie;ery cer;;;s;;en, res ;, er reveauen-ef-ad;Ga;,en presed;n e.
v B-47
o Subpart D-Certthcati:n of Laboratories Engagedin Chemical Testing 4.1 Use of OHHS-Certified Laboratories (a) Licensees subject to this part and their contractors shall use only laboratories certified under the OHHS " Mandatory Guidelines for Federal Workplace Drug Testing Psogramsh Subpart C
- Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,"(6EH:R 11070,110011000,[MW399CMf5L29008,TW) d.ed Api 11,1000,and subsequent amendments thereto for screening and confirmatory testing except forinitial screening tests at a licensee's testing facility conducted in accordance with 10 CIR
$ 26.24(d). Information 7,onceming the current certification status of laboratories is available Piiiiiiiiiiiil.6~ f Workplace l,.::;;;adFiiiiiiiiiii, CiihEiWestiilah6b"AtxEs from: The 0 o
M-x.e::..;;.. e er. Oraii AL.ee:SubstanosAtideaissiic[84entaljeast Seryloiiiji L
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, Ibiliis))535600 Fishers Lane, floclangB2 Sig.) 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-off levels as may be specified by licensees for the classes of drugs identified in this fTeart, for analysis of jiiiiiiis blood specimens for alcohol, and for any other substances included in licensees' drug panels.EBibiiiiiiiiistiii engE&silihillabiiiilbrfciiirtiG65 tion jiis665iis#MssfMiiiiicii6iisInstsidsfnEKGuideEneslIsisifiiis% more sirmgent.
autorseveis stuirisist siishisth&LHHS;GuidennesnessunglorlaukdEmani substancesg8censedi siid enisifixwenactorsithistitisoisildsissiprocaces outsids theHHS4uidianos must teln inessurestinitWconsiseentDimi:.sili::MtWassunii:sumissiriopoded;eisOesultsioiiFalidissa b
isefensuds:
s[in, usedsmiumssodassihme seguimwiseinsnissanxenfotegasoreWisino jcfat~diiiiiiiiiEliisiiteWiidWiiiiiiiisiftsesiiiiiiiiiiiia6iiEiiiiiiiiFisisiilliiili"65nsiiisi6iis"iiiiiFHHS.
NHosuntipedisexwataries, B-48
T-February 26, 1999 MEMORANDUM TO:
Willhm D. Trsvers Encutiva Dir:ctor for Operations FROM:
Joseph A. Murphy, Chairman (Original /s/ by J. Murphy)
Committee to Review Generic Requirements l
SUBJECT:
MINUTES OF THE CRGR MEETING NUMBER 332 The Committee to Review Generic Requirements (CRGR) met on Friday, November 20,1998, from 10:00 a.m. to 12:00 noon. Attachment 1 contains the list of attendees.
i J. Roe and L. Bush, both of NRR, briefed CRGR on the draft final Fitness for Duty Rule (10 CFR 26). The staff focused on an over/lew of the draft final rulemaking package which was later submitted for CRGR review and endorsement. The preser,tation material used by the staff at the meeting is included as Attachment 2. The staff indicated that the rulemaking was the most appropriate vehicle to promulgate numerous needed improvements to the rule which have been identified over the years. However, the Committee questioned appropriateness of application of the compliance backfit to several proposed changes. Furthermore, the Committee
[
insisted that before formal CRGR review, the staff obtain the required NMSS concurrence on the j
proposed rule as it applies both the reactor as well as nuclear materials facilities. Subsequently, this rulemaking was scheduled for formal review at CRGR Meeting No. 334, which was held on December 16,1998. The minutes of that meeting were issued on December 31,1998, in accordance with the EDO's July 18,1983 directive conceming " Feedback and Closure of CRGR Review", a written response is required from the cognizant office to report agreement or disagreement with the CRGR recommendations in these minutes. The response is to be forwarded to the CRGR Chairman and if there is disagreement with the CRGR recommendations, to the EDO for decision making.
Questions concoming these meeting minutes should be referred to Raji Tripathi (415-7584).
Attachments: As stated cc:
Commission (5)
SECY M. Knapp, DEDE F. Miraglia, DEDO J. Lieberman, OE M. Springer, ADM H. Bell, OlG K. Cyr, OGC J. Larkins, ACRS H. Miller, R-1 L. - Reyes, R-Il J. Dyer, R-Ill E. Merschoff, R-IV C. Paperiello, NMSS A. Thadani, RES S. Collins, NRR j
J. Lieberman, OE D. Matthews, NRR i
Distnbution-File Center (w/attch.);PDR (NRCACRGR)
CRGR SF l
CRGR CF RTripathi JMitchell JJohnson, OCM Streby BSheron ETen Eyck DDambly JJohnson, Ril GMizuno GWest Tquay RAlbert
=
DISK / DOCUMENT NAME: S:\\CRGR\\MITS-332.WPD To,cosive a copy. Indecets 'C's Copy avo allschment/enclosu,e, *A*
- Copp with attechment/encloswe: *N" a No copu NO MARK s NO COPYt oPC CRGR C.
C:CRpp C
C g f NAesE RTnpolhi -
f om a m, v
w.
l I amCiAi.RaCoRoCon
' Attendance List
-a
.c
s aasa:g g
1 UNITED STATES j
NUCLEAR REGULATORY COMMISSION t
WASHINGTON, D.C. 30086 0001
\\,,,,g */
February 26, 1999 MEMORANDUM TO:
William D. Travers Executive Director for Operat~ 3 FROM:
Joseph A. Murphy, Chairman Committee to Review Generic qui ments
SUBJECT:
MINUTES OF THE CRGR MEETING NUMBER 332 The Committee to Review Generic Requirements (CRGR) met on Friday, November 20,1998, from 10:00 a.m. to 12:00 noon. Attachment 1 contains the list of attendees.
J. Roe and L. Bush, both of NRR, briefed CRGR on the draft final Fitness for Duty Rule (10 CFR 26). The staff focused on an overview of the draft final rulemaking package which was later submitted for CRGR review and endorsement. The presentation material used by the staff at the meeting is included as Attachment 2. The staff indicated that the rulemaking was the most appropriate vehicle to promulgate numerous needed improvements to the rLle which have been identified over the years. However, the Committee questioned appropriateness of application of the compliance backfit to several propm changes. Furthermore, the Committee insisted that before formal CRGR review, the staff obtain the required NMSS concurrence on the proposed rule as it applies both the reactor as well as nuclear materials facilities. Subsequently, this rulemaking was scheduled for formal review at CRGR Meeting No. 334, which was held on December 16,1998. The minutes of that meeting were issued on December 31,1998, in accordance with the EDO's July 18,1983 directive conceming " Feedback and Closure of CRGR Review", a written response is required from the cognizant office to report agreement or disagreement with the CRGR recommendations in these minutes. The response is to be forwarded to the CRGR Chairman and if there is disagreement with the CRGR recommendations, to the EDO for decision making.
Questions conceming these meeting minutes should be referred to Raji Tripathi (415-7584).
Attachments: 4 stated cc:
Commission (5)
SECY M. Knapp, DEDE F. Miraglia, DEDO J. Lieberman, OE M. Springer, ADM H. Bell, OlG K. Cyr, OGC J. Larkins, ACRS H. Miller, R-l L. Reyes, R-Il J. Dyer, R-ill E. Merschoff, R-IV C. Paperiello, NMSS A. Thadani, RES S. Collins, NRR J. Lieberman, OE D. Matthews, NRR i