ML20247D962

Obtains Commission Approval to Publish Revised Proposed Rule Re Fitness for Duty Programs for Comment

ML20247D962
Person / Time
Issue date:	08/12/1988
From:	Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
FRN-54FR24468, RULE-PR-2, RULE-PR-26 AC81-2-132, SECY-88-232, NUDOCS 8909150164
Download: ML20247D962 (157)

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^"**'"** S"-88-232 l RULEMAKING ISSUE.

For: The CummisgpE NEE From: Victor Stello, Jr.

Executive Director for Operations Sugcct: PROPOSED RULEMAKING - FITNESS-FOR-DUTY PROGRAMS Forgog: To obtain Comission epproval to publish a reviseo, proposed rule for comment. ,

Eackaround: SECY 88-129 of May 10, 1988, provided the Comission with a prcposed rulemaking th6t would require licensees, authorized to operate nuclear power plant rec.ctors, to implement a fitness-fer-duty prcgram. The Conrission was briefed on the proposed rule and the supporting rcsearch on June 21, 1966. A Staff Requirements Merecrandum (SRM) of July 18, 1988; directed the statf to make specific revisions and return the proposed rule for Commissicn review and approval by negative consent.

Discussicn: The modifications to SECY 88-129 have been ccmpleted cs airected by the SRh. A summary of the stuff responses to the SRM is enclosed which ir.dicates the Notice of Proposed Rulemaking (NPR) page numbers that contain the modifications to each item. To facilitate Ccmmission review, the revised draft NPR is annotated to indicate the SRM items.

The Commission indicated that it wished to select the testing rates. Various alternatives are provided. Should the Conaission select a rate different than that proposea by the staff, the NPR will be appropriately revised before publication.

After discussions with OGC, the staff has modified the

- Regulatory Analysis previously provided with the proposed rule. The beckfit analysis states that the staff has made a preliminary finoing that the rule will provide a substantial increase in the overall protection of public health and safety 6nd that the direct ano indirect costs cf implementation ere justified in view of the increasec

Contact:

Brian Grimes, NRR -,

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f. q The Commissioners protection. .The staff also believes, ano the CRGR has concurred, that a finding could be made t. hat the rule is necessary to provide adequate protection to the health and safety of the public and thus not subject to bcckfit analysis. The NPR requests comments on which of these two options is the more appropriate for this rulemaking.

0GC has no objections to publishing the rule for comment as modified, and the CRGR hus reviewed cr.o approved the changes.

Recommendation: That the Commission approve the revised Federal P.egister Notice and proposed rule. We will issue this rule within five (5) days from the date of this paper unless notified otherwise by.the Commission. / . :,. - . -

m-73.-

Victor Stello, Jr.

Executive Director for Operations

Enclosures:

1. Summary of modifications in response to SRM dated 7/18/08

2. Notice of Proposed Rulemaking

3. Backfit Analysis Draft SECY NOTZ : In the Absence of instructions to the contrary, SECY will notify the staff on FRIDAY, August 19, 1988, that the Commission, by negative consent, assents to the action proposed in this paper.

DISTRIBUTION:

Commissioners OGC OI OIA GPA.

REGIONAL OFFICES' EDO ACRS ASLAP ASLBP

. SECY -

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• i Enclosure 1

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SUMMARY

OF MODIFICATIONS IN RESPONSE TO.3RM DATED 7/18/88 Item 1. Ensure broad fitness-for-duty program.

$ 26.20 (page.105) revised to add legal drugs (e.'g., alcohol, prescription and over-the-counter drugs) anc consideration of mental stress, fatigue, and illness. Conforraing changes. have been ?. ace to the discussion.

Item 2. HHS Guidelines should be minimum standards.

A conforming change to the proposed Notice of Proposed Rulemaking (NpR) was made on page 57 to suppcrt the earlier change to

?26.24(h)(page108). " Minimum" was aodec to cuestion nuraber 4 on page 5.

Item 3. Statistical calculations for selection of a testing rate to prcvide a high percentage of the population tested at least once and a low percentage tested more than once in a year.

Sampling strategies and probabilities related to this issue are on pages 53-55. Evaluation of alternative models indicateo that the objectives of assuring that a high percentage of the population is tested once per year and a low percentage is tested rcore than once in a given year, could be achieved using a testing strategy which, it.

effect, intensified the rate of testing for those who had not been selected for a random test, and continued testing the remainder of the population (tested and found drug free at the time of the test) at a reduced rate.

An example of a sampling strategy which achieves these objectives is given in Case 9 of Table 2 (page 54b). This option calls for testing at the rate of -100 percent of the total population per year with a reduced rate of 30 percent per year for the actual tested population.

The population would be redistributed into tested and untested populations monthly.

2 Enclosure 1 This would provide the following changes from the previcusly proposed testing rate of 100 percent per year:

Probabi'ity of 100% 100% for untested being selected flat rate 30% for tested Adjusted monthly Not at all .37 .09 At least once .63 .91 At least twice .26 .21 At least three times .08 .06 Total tests for 1,000 workers 1,000 1,128 Raising the testing level somewhat (to 125 percent per year as in Case 10 of Table 2) would assttre that nearly all individuals were tested but would result in half again as many individuals being tested a second time (30 percent rather than 20 percent of the i population).

While Case 9 of Table 2 achieved an acceptuble balance among the program objectives, it may not be the only method which does so. Tu (

allow a reasonable amount of flexibility in program implementation, the staff proposes to state performance based objectives rather than a specific methodology in the rule. The rule as proposed would require random tests to be administered in a way that at least 90 percent of the individuals within the scope of the rule are tested each year, that testing be performed throughout the year and that testing rates for individuals already tested with negative results not be lower. than 30 percent per year (21/2 percent per month) for the remainder of the testing year. However, it should be noted that the deterrent effect potentially will be reduced for the tested population.

Item 4. Specify minimum time before an individucl may return to duty following the first confirmeo resitive drug test. Provide appropriate justit1 cation.

The staff recommends that the first confirmed positive test require removal from unescorted access for at least 14 days, and that during this suspension period, the individual be referred for assessn.ent and counseling, development of treatment, follow-up, and future emplcyment plans, and initiation of a rehabilitation program, if l deemed appropriate. Assurance of fitness must be obtained prior l to return to duty. With this approach, individualized programs can I be developed. In appropriate cases, the duration nf the suspension can be much longer in duration than the minimum two weeks.

$ 26.27(b)(1) (page 110) has been revised to reflect this .

recommendation.

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4. F 3 Enclosure 1 The technical discussion that supsurts the staff reccamendnion is at paSes 65-74 of the NPR. Thet discussion points out that orug-abuse " careers" vary to a greht extent between individuals, that the-

' length of time uncer treatment (for those with chemical dependence) should extend for several years, that recovery is more a process than p .a' state, Land therefore, treatment programs need to be tailored to the individual. No recommendation.is made on whether the suspension.

must be without pay.

' Item 5. ' Evaluation process before permitting full return to duties following -

3/5 year removal periods.

[ E6.27(b)(3) (pages 110'and 111) has been added cno requires:

Medical assurance of abstinence from drugs for at least three years; Satisfactory management and medical assurance of fitness.

• Unannounced follow-up tests at lee.st cr.ce every three months-for. three years af ter granting or reinstatement of access.

Item 6. Permanent denial of access for involvement with drugs after suspension and subsequent reinstatement of unescorted access.

5 26.27(b)(3) (pages 110 and 111) has been added and requires that dny Confirmed use of drugs ~through the process developed in response to item 5, above, or any other determination of subsequent involvement in the sale, use, or possession of illegal drugs shall result in permanent denial of unescorted access.

Item 7. Consistent-tracking systems in proposed rule and Access Authorization Policy. Define " suitable ir.quiry."

L " suitable inquiry" has been defined (page 104) to be consistent with the eniployment history elenent of the background investigation in the Access Authorization Policy. l'E6.27 (pages 109-111) has been revisec to support the conduct of a suitable inquiry.

Item 8. Rationale for adopting certain provisions of the rule.

(a) The basis for the conclusion that rulemeking was necessary was expanded (page 3).

(b)~ The basis for concluding that licensees progren.s anequately address alcohol was provided (pages 62 and 63).

(c) The justification for the rate of random testino is provided on pages 53-59 (see niodifications in response to item 3).

(d) The discussion of issues regarding ver edited to more clearly discuss the issuespage (y low cutoff levels was 63),

(e) The rationale for those persons included within the scope of the rule was proviced (page 75).

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4 Enclosure 1 -

Item 9. 'Conarnt period shculd be 60 days.

Revision mace to NPR (page 2).

Item 10. Request comments on additional methods of determining impairment.

Comments requested (phge 5).

Item 11. Include specific reporting requirements.

5 26.73 (page 113) was expanded to neke clear that the Conmission shall be informed of significant' fitness-for-cuty events including:

Sale, use, or possession of drugs within the protecteo area, and, Any such acts, whether onsite or offsite, by a licensed recctor operator or by supervisory personnel assigned duties within the scope of this part.

Notifications would be made wi . 'in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Written reports in 30 days documenting the actions ta.en would be required.

Item 12. Collection and analysis of program performance data ano auolts.

(a) 6 26.71 (page 113) was expanded to require licensees to collect and analyz6 data, and to take appropriate actions to correct any

- program weaknesses. A proposed NRC form is provided for comment (pages 118-119). Submission of the dato to the NRC is not required. -

(b) 6 25.80 (page 114) wes aoded to reouire licer: sees to oudit their fitness-for-duty progrom ano those portions of the programs implemented by contractors.

Item 13. Clarify subject of legal drugs; request public comment.

Comments requested (page 6).

Legal drugs are among the items ac. cessed in the modifications made in response to Item 1.

Item la. Backfit analysis.

• After discussions with OGC, the stoft has modified the Regulatory Anhlysis previously provided with the proposeo rule and now makes aVailable the draft backfit hnalysis for public Comments (pages 96 and 97). The backfit analysis states that the staff has mace a preliminary finding that the rule will provide a substant1hl increase in the overall protection of public health and sdfety and that the direct and indirect costs of implementation are justified in view of 6

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p the increased protection. _ The staff alsc believes, and the. CRGR has .

concurred, that-a finding could be. made that.the rule is necessary to provide adequate-protection to the health and safety of the public:

and thus not subject'to backfit analysis. The NPR requests cenunts on which of these' two options is the more appropriate for this rulemaking.

sitem?IS.. Editorial comments.

The NPR has been revised to incorporate. the editerial and narginal comments provide' ': the marked-up version of SECY 88-129. 1he more significant revisions are on pages 39,- 75, and 80.. .

Note on adequacy of appeals system.

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The t!PR has'been ecdified (page 5) to more specifically request comments en additional cuality control mea:.ures or appeal proceoutes -

that should be considered to ensure that individecls are not misidentified as drug users and to provide a mechanism to correct any errors.

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.6 Enclosure 11 E  : INDEX OF' MODIFICATIONS.

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- SRM-ITEM SECY~PAGES i

'l- 1, 74,-75, 105 2.: 5, 57c i 3; 53-55, 77, 108 4' 65-74, 78, 79,'95, 96,'110

5. 110, 111-6 79, 111-t 7 80, 104, 109, 110, 111

. 8(a)( .3 8(b) 62, 63 9 2 10 5-

- 11 81, 113'

' 12. 80,'81, 113, 114, 117

, 13 6 14 96, 97 15(Secy mark-up) 39, 74, 75, 78, 80 SRM' note. 5 OMB 97, 105, 112 U

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l f: NUCLEAR REGULATORY C0!411SSICN 10 CFR Part 26 Fitness-for-duty Prcgrc.m AGCNCY: Nuclear Fegulatory Comraission. l i

ACTION: Proposed rule.

SUMMARY

The Commission is proposing to cre6te e new part to its regulations to recuire licensees authcrizeo to operate nuclear power reacters to implerrent a fitness-for-duty program, the gereral objective cf which is tc provide reasonable cssurance that nuclear power plant personnel ure not under the influence of any substar:ce, legal or, illegal, or mentally er physictily ,

impaired from any cause, which in any way adversely affects their ability to  :

safely and competently perform their duties. One major element of a iltness-for-duty program and the focus of this rule, is to assure safety by creating an enviror. ment which is free of the effects cf drygs, The rule would, with limited exceptions, apply to ell individuals granted unescorteo access to prclected areas, and to any licensee or contractor personnel recuired to respond to the licensee's Technical Support Center (TSC) or Emergency Operations Facility (EOF) in accordance with licensee emergency plans oro procedures. Under the proposeo rule, testing for impermissible drug use woulo be conducted prior to authorizing unescorted access to protected creas or cssignment to other activities within the scope of the propcsed rule, rde.denly for such licensee and contractor personnel, after certain cperationc1 events, based on reasonable cause, and to verify continued abstention. Iri addition, the proposed rule provides fer cther basic fitness-for-duty prcgram elements such as the development of written policy and procecures, provisicns for f.e training of supervisors cnd errployees, standards for drug testing, management 1 Enclosure A

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scticns,l arKrequirements fer employee essistance prcgrams 'and appeal t

prccedures.

DATES: Comments should'be submitted by'( ). .:# 7 Comments received'ufter this date' will be considered if it is practical to do

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so, but assurance of consideration cannot be given except_as to comments received on or befcre this cate.

ADDRESSES: Coratents should be sent to the Secretary cf the Commission,

" Attention: Docketing and Service Br6r.ch, U.S. Nuclear Regulatcry Commission, Washington, D.C. 20555, or may be hano-delivered to the Of fice of the Secretary, U.S. Euclear Regulatory Commission,11555 Reckville Pike, Rcckville, Maryland, between the hours of a:30 a.m. and e:45 p.m. weekdays.

FOR FURTHER INFORMATION CONTACT: Loren Bush, Peactor Safeguards Srcrch,.

Division of Reactor Inspection and Safeguards, Office of Nuclear Reactcr Regulation, U.S. Fuclear Regulatory Commission, Weshington, DC 20555 Telephcne: (301)-t92-0944. .

. SUPPLEMENTARY-INFORMATION:

Backgrouno On August 5,1982, the Commission published for conti.ent a proposed rule to require licensees-to develop and implement written procedures concerning fitness for duty (47 FR 33980). Sevt.nty-three responses containing 310 comments were received and considered ouring the Comnissich deliberations cn the proposed rule (51 FR 27872). Subsequently, in recognition of init16tives l

ano commitments made by the industry to develop and self-menage l iitness-for-duty programs, the Commission cecloed to defer implementation of I-the rule, to issue a policy statement to further enccurage such self-1Eprovement and to reconsider the need for rulem6 king after evaluating the experience gained unoer the industry program. The Commissitr.'s Policy Statement on Fitness for Duty of Nuclear Power Plant Persohnel was published in the Federal Recister on August 4, 1906 (51 FR 27921). Ten respondents commented on the policy statement (SECY-87-64). On December 1, 1987, the i i

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- 2 Enclosure A

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- Consissictt wos briefed by the ~ Nuclear. Utility t'ar.agement end Resources Ccuncil

!(NUtdARC)'ond the hRC staff cn the experience gaired to date ord on the stetes-

. of irrplenentation of. the Cocinissict.'s fitness-for-duty' policy statement.

Discussion The.Conmission recognizes and appreciates the significant effcrts already undertaken by fMARC, the Institute of tiuclear Power Operations (It:PO), the Ecison Electric Institute (EEI), and each nucieur power reacter licensee in oeveloping and irrplen:enting fitness-for-duty programs for nuclear power plert personnel. Much progress has been made thrcugh the industry efforts in achieving an environment in which nuclear pcwer plant crerations are free of the effects of alcchol ano crugs, t!everttcless, tne Ccrtmission's aclbotkn- cf expcrience gained in the 18 mcnths since tFe policy staterrent teceme effective indicates that rulemeking is new appropriate. During the December 1, 1987 I briefing on the implementatier, of the policy statement, the Consissicn wcs inforrred'that licensees Iid not have uniform progrem standards, there were significant differences in key program elen:ents, and that there were many factors that made it unlikely that the nucicar inaustry could achieve ,

uniformity at the desired level. For example, (1) not all licensees were conducting rar. dom tests,. some because of union intervention et prchibiticn by state lws (2)' drug testing cutcff levels varied significantly,~ sorre of which g were inadequate, (3) disciplinary actions in response to positive test results varied partly due to the degree of locel tolerance toward the verious fitness-for-duty conditions, and (4), training and awareness programs for contractors needed to be improved by many licensees. The current and apparently continuing lack of uniformity in these key program elercents was the basis for the Commission request that a preposed rule be prepared. The rule is designed to take into account existing pregrams, rectify the shortcomings as stated above, anc establish uniform stencarcs to promote the petlic health and scfety. 1 The proposed rule takes into account the many positive aspects of existing industry prograrps while providing for more uniform program standards, with due 3 Enclosure A

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3 regerd tolboth' public and wcrker safety and the rights c,f individuals. -In Loev' eloping-this prcpused' rule, the NRC staff ~ considered public cremerits

. received;in response to.the 1982 proposed rulemaking and the 1986 policy stat'ement. :The' staff also censidered industry experience reported to the

Commission,'together with lessons-learned by.the staff from ev61ueting the effectiveness of utility.' fitness-for-duty programs, from' assessing' reported

. drug.related incidents,.and- frcm reviewinc. similar r ules being developec by

- other Goverrrent1 agencies.

The' Commission' also considered whether the- preposed ru!e shoulo be- appliceblev

. to persons having access to.ir. formation requiring prctection, such as. notict:al security inferiration, safeguards information, or proprietary inforniatico. The Commission believes that determinations of eligibility for access to procected information based cn the current 10 CFR Part 10, or the proposed 14uclear Fcwcr

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Plant Access Authorization Program policy stater:ent reblishea on Merch 9,1988 (52 FR 7534) .will provide a suitable rtechanism to protect that inforrr6ticr.

from those'inciivicuels whose trustworthiness may be in question.

In considering the minimum requirements of this prcposed rule, the Commission has oecided to require certairi programs that could be vieked as rightfully being. left to the'oiscretion of licersee managertent in structuring their programs to meet fitress-for-duty obje Nes, dealing with employees, and in establishing'their benefits. For example, the Commi'.., ion proposes to recuire that licensees maintain Employee Assistance Prcgrams anc that individuals be

. trained in the health hazards of drug' abuse. The Comissier. seeks corrnents as to whether these prograrc elements should be in the rule or included as recommendations in implementing guidance.

In addition, the Concission has preliminarily decided not to include several

rratters in the- rule. These matters are.surmarized in the Appendix to this

,. federal Pegister Notice. The Commission seeks con.rrents as to whether these matters shculd be adced to the rule or includco as reconnendations it in.plementing guidance. In this regard, Public Citizen (a public interest group) submitted a letter on June 4,1987, petitioning the Commission to aniend its regulations to require licensees to report: (1) all instances of drug and

... 4 Enclcsure A

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s alcchol'use by personnel;whil'e on dety, (2) the details 6f..fitress-for-duty programs, (3) the results of rehabilitation programs, and '(4) the iesults.cf (drug testing progran.s. This letter was not noticed due to'the moratorium on

-rulemaking on fitness for duty. established by the Comission's Policy Statenient L(51; FR 27921). However, NRC. staff communicated with Public Citizen and inforrred them of the Comissicn's intent to address the issues raisec. The JCommissicri will- acdress this request in conjunction with'its consideration of public comn.ents provided in response to this. proposed rule.

The Certrission. seeks corrrents fra. knowledgeable persons on' the seitntific and technical basis of the proposw .fu e and the consequences of drug use on the Sdit, cperation of a r,UClear pcuer reactor. The Commissien also seeks commei.ts ori the follwing:

1. 'Are'there practical alternatives to randcm testing, nct discussed herein, that provide'equivslent detorrence ano detection of drug ust?

, 2. _ Khat practical' alternatives, not discussed herein, exist that could g determine physicel and trental irrpairment?  ;

3. L'bnt' rate of randcm testing provides an acceptable probability cf

.petection and adequate deterrence? What should be the basis for any future modifications in the rate for ranoom testing?

4. Are there any reasons why the Commission should not adopt, as minitrum j4 ster.dards, the " Mandatory Guicelines for Federal Workplace Crug Testing Programs" issueo by Health and Human Services (HHS) en April 11,19EC (53 FR 11970) for fitness-far-cuty programs at rcclear power plants?

5. Are there any additional cuality control necsures or appeal procecures that s'nould be considerec to protect the rights of individuals being tested, to ensure that individuals are not misict.ntified in the process as ggfj drug users, and to provide a mechanism to correct any errors? Mars 5 Enclosure A

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6. !Should tre Cerernissicn piovice general ruidance on pottrtial irrpirments, g such'as a?cohcl abuse and prescription crugs? .

.7. . How long; stculd a person be barred from performing activities within the Escope of the proposed ruls followirg removal under the fitotss-for-duty

.,  : policy,4 and under what circumstances should reinstatement be allcwed?!-How long should records of this ren. oval- te retained to facilitate future errployment' decisions?

8.,  : Finully, the! Commission is' especially-interested in reulivir;r corrnents ce the extent tc which hRC regulations: en fitness for duty should adoress cther regulated activities not currently witFir, the' scope cf this prcpestid

. rule. Regulateo activities being ccnsiderec for rulerskir.g ci a Cchalssicr. statement of' policy include:

.The construction and pre-operational testing of nuclear power plants.

prior to the issuance of'a licu.se and the loading of nuclear fbel.

The operation of nonpower reacters used in academic, research, and commercial applications.

Fuel 'ecle facilities involved in the possession and processing cf plutonium or uranium in highly enriched, icw enrichec, or natural uranium forms.

The utilization of nuclear materials in o'ther activities such as radiography, product irradiation, racicpharmaceutical procuction, nuclecr meaicine, uranium milling activities, production and use of various sources, and racicactive waste disposal activities, k.'hile fully supportive of programs to eccress the national problems of drug and l I

alcohol abuse and to previde for the realth and safety of ircividual werkers,  !

i the Conrnissien's policy on the regulation of fitness-for-duty program:, for j persons' involved in the abcVe' activities will primerily be based upon l considerations for the safety of the public cnd fellow workers.

.. 6 Encloscre A

I x:/

.In!the r,atter of' requirements 'fcr fitreess-for-duty programs' at nuclear power.

plants' undergoing constructier and pre-crerationel testing, the Corrmiss itr.

requests views'on:1(1) the relative safety sigreificer.ce of the wide variety of fspecif.icconstructionstepsandcraftsinvol.dd,(2)theextenttowhichthe

, controls; described above do or do not teno to provide adequate identification-or mitigation of individual failures in performance in- these areas and, accorair. gly, (3) the nature and extent of'any fitness-fer-duty program elen,ents which should be ' applied to these, activities. An example.might te the welding

of reactoripriniary system boundaries, structures and supports, one safety-reitteo systems, as' opposed to balar.ce cf plant welding.

Althcugh: fitness for duty prcgrams are intended to provide reoscnable assurance.

that it:cividuals arel not using cr under the influer.ce of any substence, or mehtally or physically impaired frcm any cause that could adversely affect safety, the' specific prcgram elements and procedures contained in the proposed

--rule apply.only to drugs. In meeting the proposed rule's requirements that -

licensees proviae reasonable asstrance that its employees are fit to perform their_ duties, specific neasures.for addressing alcchol, legal drugs; ano otter -

health problems, such as. mental stress and fatigue, are left to,the discretion

.of each licensee.

Options Considered In developing this proposed rule, verious options were considered covering the following subjects:

I. Impairment and reliability.

l The use of alcohol and drugs ccn c1rectly impair job performance. The effects of alcchol, which is a drug, att well known and documented, and therefore, dre not' repeated here. Drugs such as marijuar,6, sedatives, hallucinogens, and high ccses of stimulants could adversely affect on employee's ability to correctly

. Judge situations and rrake decisions (NUREG/CR-3196, " Drug and Alcohol Abuse:

The Bases for Employee Assistance Programs in the Nuclear Inaustry," available from the National Technical Information Service). The greatest impainrent 7 Enclosure A O

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occurs shortly af ter use or abuse, and the negative short-term effects.cn human ]

periormar.ce (including subtle or narginal irrpairments that are difficult f or a l

~ supervisor to oetect) can last for severcl hours or days. .

The problem with determining impairment is that there are many degrees of .

physical and trental imphirment, sorre of which cannot be detected by current n.ethods. Furthermore, a pos1tive urine test does not establish that'on indivioucl is currently subject to any physicicgical or psychological tffects l l

of a drug. The most airect treasurerents of current impairrrent froi.. te.sts of j body fluics are obtained from tests of fluio it. brain tissue, follows.d by tests i i

of blood serum. Although e positivt urine test may nct inoicate current impairtrent, it can provide a reasonable belief and conclusion that the person was impaired or trargir. ally inpaired. For trese reascr.s, tne actier:s taker, ty employers in response to drug use ere typicelly based on " reliability" determinations rather than observable evidence of impairrrent.

Reliability determinations are based upon a well-founoec cssurrptico thdt the use of the drug or alcohol results in inipaired motor and mentcl functioning.

The assumption that the use of illicit crugs and the irisuse of alcchcl can cause significant on-the-job impairment is supported by the scientific literature, The finoings of the studies cited herein suggest the likcly eff ects of substance use cn job performance at nuclear power plants. These were refereed studies (i.e., subject to peer review by experts in the fielo prior to publication) and so represent acceptable experimental techniques with findings that are likely to be valid.

. The following provides a sumirary of the research literature on drug use end irrpairment fcr the five drug types for which random drug testing is requirec (marijuara, cocaine, opiates, phencyclic' ire, and arrphetamines). The recently published "Second Triennial Report on Drug Abuse ono fsrug Abuse Pescarch to the Congress," frcn the Secretary, Departu.ent of health and Puman Services, publisheo in 1987, contains a sunniary of recent research fincir.gs which are consistent with those described below.

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8 Enclosure A 1 -

y A. Marijuar.e-I . .

l 1._ Background.

Frequent smoking of marijuana is asscciated with a decline in social, niental,

-and perceptual skills. Marijuana intoxication impairs motor vehicle driving skills _ such as motor coordination, eye tracking skills, ano perceptual functions (Schwer: ond Pawks, 1985). Mar ijuana intoxication in.;.cirs sensory / perceptual performance such as hearing enc vision (Vurray, IPPf).

Marijuana intoxication ccu shcrten attention span, impair motor skills, decrease manual dexterity, and impair mctcr steadiness (Murray,198t,;

NUREG/CR-3196,1983).

Marijuera intoxit.ation impairs cognitive anc performance tasl:. -(fehr cr.d Kalant,1983). Studies have shown forms of cognitive impairment such as interference with learning, impaireo numerical reascriing, and interference with the transfer of infor1r.ation f t om short-tern. to long-term memcry and 5.u.ceptibility to distraction or stress (Murray, 1985; NUREG/CR-31PC, 1983).

The larger the dese, the greater the rceived subjective effect of a "high" and physiologic indexes, such as increased heart rate (Plum, 1984). Research has clearly deacostrateo thct the degree of im;)airmt.nt in !cdividual subjects is dose related; i.e., the greater the dose, the greater the degree ci impairment (Chesher,1966). It should be rcted that the potency of street samples of marijuana continue to rise, typically two to four times (ano for some 14 tires) as potent as that used in most rcsearch (Cohen,1986). The implication is that impairment from marijuana is likely to be more acute than that reported in the literature.

There are significant cifierences between casual and heavy users of ri'ar1Juana.

In one stucy, casual users of marijuana made five times as rharry errors ori a divided-attention task when they were smuking an ad libitum cose of marijuana as they did when they were smoking the plocebo. Feavy users did not. show any increase of errors in the ad libitum dose condition. A similer study corrpering casual anc ht.avy users shcwed that becvy users displayed more hostility, pccrer work adjustrhent, and worse internrsonal relations than did the casual users.

(Murray,1986).

9 Enclosure A

jf. '

Thel effects 'of marijuareinicxication ons sccial. interaction varies. Some_

= subjects beCOFC[hitharawn;i ether subjects:mure cggressive. Psrijuor.a

' intoxication ger.eraHy affects social behavicr and interaction ir. ^a variety cf

measurable:forins',' a fact with son.e implications- for crew as well as: individual Performance; nThe effects.of ratrijuar,a intoxication cn vehicle driving performance dercostrateo that those who were intoxicated had worse ccaposite' driving perforniance -thanhthose who here notc intoxicated. ' The'st.udy cisc showed thet -

even smell.dosesicf mcrijuana impaired driving Ability (Klonoff, 1974; Febr-and Kalant, 1083).

The effects of marijtecna on dircraft pilot perforraance shcwed that retrijuana can produce residual: behavioral effects 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> cfter ingt.sticn. Simple-

performance measures returned withiri b6seline levels in c relatively short tin.e;. highly ccrplex skilled performance aspecta of the task shcweo ceticits 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after-.incestion (Yesavage, et al.,1965; halsh,1987). Pangcver effects

. of marijuana-induce significant. residual st.bjective and behavioral effects at le6st nine hcurs after smcking (i.e., the next morning) (Chait, et al.,1965; Walsh,1987).

Relctively-low ~ amounts of marijuana combined with cicohol can have serious disruptive effects ~cn performance (Sutton, 1983; Ross and Ross, 1985). Gn some tasks, the effects of combined alcohol end marijuara have shown an antagcr.istic or.less than-additive reaction between the two drugs.- Low deses of marijuana

-ccabined w'ith alcohol produced an antagonistic eifect; high doses of marijuana

-combined with alcohol. produced additive effects. The effects prcduced by these drugs when used singularly and in combination produce qualitatively ard

. quantitatively different effects (Chesher, 1986). Another study ccricluced that both:marijuara -ano alcohol had significant ef fects on drivir,g prformtr.ce, and the effects were particularly detrimental when both draos were combined.

Parijuan'a effects were more rapid than those of alcohol and scrrewhat less severe for most tasks (Peck, et al., 1966).

l 10 Enclosure A

. g-

_im.i______._____._________._______...________._____m_ _ _ _ _ _ . _ _ _ _ _ _ . . _ _ _ _ _ _ _ _ . _ _ _ _ _ _ . _ _ _ _

mym .

c Combining 'alcctol with marijuana can significantly impair cognitive and' task

performance.- Studies of airplane pilot perform 6nce'in siruulcted flight Lderrcostratec that: pilots made significant major errors- (becoming lost or-4 - . stalling) and minor errors (altitude and heading deviations) in performance,

' even though- they knew they were under the influence of marijuana and ettempted to compensate for the ~ effects '(Jen'owsky, et al. .1976; Ross and Ross.1985).

Sin.ilar driving simulator. studies showed major performance decrements (ability m

to traneuver, negotiate curves, following another: car, passing a car , etc.)-

(Smiley, et 'al. ,1981; Mos kowitz,1985). Pt.rformance decrements' art elso noted

.for handsteadiness, execution of moverrents, at:d boay sway (Moskowitz,1565):. A battery of ccgnitive tests also revealed performance decre.ments that WEre additive when marijuera and alcohol were combined (Chesher,1986).

Pased on a scriety of actual ana sin.ulated drivir.g pertorrnance under the influence of marijuana, the study notes that subjects intoxicated on marijuara

. appeared to realize thut they were impaired cr:d comper. sated for this impairroent on task' performance whenever they.could. Such compensation is etviubsly net possible. in unpredictable or einergency situations (Smiley,1986).

One study notes that when the subject is intoxicated due to marijuana, even thcugh the subjective. feeling of being "high" tray no longer be present, performance. decrements may still exist, possibly lastir;g several hours. Thus an operator may be impaired without realizing that his or her performance. is still teing affected by marijuana intoxication (Blum,1984).

Factors such as dosage, degree of irrpairment, and age and experience of the operator must be considered when generalizing frcm clinical results to wcrk settings. (Fehr and Kalant,1983). Other factors for consideration include

'the type of task to be performed and the envirorcent in which it is performed.

Studies of the lon9-term or chrcnic effects of marijuana use on behavior are

-sparse. However, one study notes that heavy chronic cannabis users exhibit behavior labeled as " motivational syndrome". Characteristics of motivational

syndrome incluoe apathy, reduced dri'.e and ambition, irrpaired ability to carry j out complex tasks, failure to pursue long-term piens, reduced tolerance to l l l

.. I'l Er. closure A

- _ _ _ - _ _ _ _ - _ _ _ _ _ _ __ l

f rustraticn, Leircinished ccanunicaticn~ shills, riv.glect nf. perscnal eppearc.nce,

'cr.d; sluggish:inental respcnses. These characteristics are nct specific tc.

chronic cannabis use; they are' f%:.6 with d. number cf. psychcoctive drugs,

primarily those of. a sedative-hypnotic nature, and roay be 16t,eled " chronic connabis intoxication" (Fehr. and Kalant,1983).

Lasting effects..of marijuer.a use may impair the transfer of r.cw inferrrotion

1nttilcng-term tremory storage-(Fehr and Valent,1503). There is increasih5 evidence' that lorig-terni, chronic use cf marijuor,a may' lead to adverse health-effects in the inoividual-(Cohen, IS66). Hcwever, errpirical evioer.cc linkirp the etfects of chronic ~ use tc decteased performance is not' as well developed es are the acute effects of recent use or intoxication. Marijuana . car, iricuce Jucute

remory irpcirnerit that directly affe. cts learr.ing thrcugh e cofunctico of

• -normal stcrage ar.d retrieval nech6hisms (See discussion, Walsh,1987).

2. Physical Signs of Abuse.

Symptoms of marijuana drug use are chronic fatiguc anc lethargy, chronic dry irritating cough, chronic sore tti reat, chronic conjunctivitis (red eyes), or dileted pupils (Blun,,1984).

. Tolerance and Withorawal.

Tolerance to cannabic is coniplex. It is kncwn tnat tolerar.ce to tetrahydrocannabinol (THC) develops with prolonged use. Novice users have a mcderate degree of tolerance which actually decreases with repeated use.

Tolerance then increases with heavy use. There is no oeiinitive evidence that chronic users require ir. creasing errcunt of THC tc traintair the same effects.

Experienced users 00 withstand higher doses than novices, though, ard it is evicent- that chronic marijuana users develop tolerance to the effects cf ThC (Agurell and Hollister, 1986; Blum, 1984).

hithdrahal symptoms after marijuana intoxication are mild, such as lassituos cr mild heocache. Withdrawal syn.ptorus ofter chronic marijuaria use is halted 12 Enclosure A -

I

(e.g. .. heedaches, strcach crainps, feelings of lassitude ) are attributea to psychological depender.ce (l'urray, IgCC).

4. Discussion.

The studies to date have focusec upon the observable short-term effects of marijutna: intoxication. These studies cf marijt6na intoxication show significant effects cr. cognitive and physicel tosk performance. The fir.cir.gs are not entirely conclusive; there are ir. consistencies, for instarce, on the findings regarding memory anc learning. This is ettributea to the methodolc9y of the studies as well as the unique characteristics of connebis, which 1s a complex psychoactive substance. The majcrity of studies suggest, however that the r: ore complex a physical, cepnitive, or behavicrel task becomes, the greater the likelibced that detectable marijcar:d intoxication will significantly affect or impair performance. Certainly, the performance of both routine and emergency-related tasks in a nuclear pcwer plant would usually cualify as complex.

Long-term studies of chronic marijuana use ure less conclusive. This is attributed to the general inadequacy of reported data in clinical studies; peor scmple size; ar.c a lack of adeoucte oiffercntiatico tett.eet, ir.tcxication, withdrawal, and residual change. There is also an absence of before-and-atter lor.gitudinal stucies of regular users (Fehr and Valent,1983). Evicence is accumulating that marijuana may also have long-term health effects which directly affect performance, such as impaired memory (fourray,1986). Long-term adverse health effects due to chronic use, such as physiological damage, are increasingly evicent (Cohen, 1986).

Cultural ano sociceccnomic factors may it. fluence the definition end ideratificaticn of adverse eftects, especially ttcse related to complex emotional er ccgnitive functions (Fehr and Kalant, 1983). For exemple, impaired cognitive ard task performance due to mo 1 juan 6 intoxication is more likely to be recognized in a ccntrol rocm operator than a janitcrial worker.

13 Enclosure A

FF ,

_Q<

LCannabis' use is usually combined with tobacco ar.d alcohcl, art less frequently'.

.fwith cocaine, phencyclidine (PCP), ano other drugs. When cabined with cther drugs, the effects-of cannabis en the user can be influenced by the other

' drugs;' cannabis can also affect the reaction of other crugs in the system (Fehr i and ' Ka lant , 1983)'.

Partjuana is known to impair" human intellectual judgment, short-term trerrory, L and; psychomotor functionshsuch es driving.an automobile (fiurray, 1966)..

Research in the complex psychoactive crc behavioral effects of marijuara has.

i produced somewhat limited and evelified conclusions. 'It is.known, however, thet'niarijuana can significantly impair perforn:or;ce curing intoxication.

.lmpairrent due to hangover effects, chronic use, and withdrawal are also l.

possible.

B. Cocaine 1.' Background.

Cocaine is a central nervous systeni (CNS) stimulant. Cocaine has trany be.havioral and pharmacciogical properties which are similar to amphetamines

. (F1schman,- NIDA Research tionograph #50,.19D1). Cocaine primarily affects brain functions. Cocaine can induce feelings of euphoria, relieve fatigue and boredor,~ and produce effects which are similar to local anesthetics (Vashton and' Gold,1987). Given cocaine's recent elevation to the status of a major drug of-abuse, cocaine psychopharmacology ar.J stuaies of the general behavioral effects of its consumption by human beings are not as well developed as studies of:other drugs of abuse (,lones, NIDA f<esearch Monograph e50,1984). Methods of consuniption and arrounts of dosage vary widely. Cocaine consumption has risen cramaticelly ir. the United States throughout the 19P0s. Cocaine is-listed'as' second among the top 20 ccetrolled substances in 1980, or a percentage increase ef'253 percent for emergency room mentions in a 69 eor period (Frank,1907).

Cocaine is a powerful drug; single doses have been known to induce seizures

-(Washton and Gold, 1987).

- 14 Enclosure A ,

1

' gg 3 " ~a

"[.,

2.' Effects on Performance.

The primary physiological effects of cocaine are cardiovascular: -heart rate,

. blood pressure,' and body temperature are significantly raised following ingestit,n (Byck,1987)._ The effects' caused by cocaine are relatively short in-duration.. Cocaine heightens mental stimulation-(Jones, f.'IDA Research Monograph

1. 50,1984). -Many. cocaine users believe.that ccgnitive ard task per fcrn.arce is

beightened unoer the influence of cocair.c. Studies do not suppurt this contention (Fischnan, NIDA Fesearch Mcnograph f50,1964). Subjective mccd profiles of individuals under the influence of cocaint revealed heightenec confusion, anxiety, friendliness, vigor, elation, arousal, arc positive disposition,ii.e., moods characteristic of stirrulant or amphetamine use (Fischman, NIDA Research Vcncgraph #50, 1984).

Cocaine intoxication drarratically affects vision. Studies have demonstrated that visico is. impaired during cccaine intoxication; subjects reported increaseo sensitivity to light, halos- around bright objects, and difficulty

. focusing the eyes (Siegel, 1987). During one study which measurea ariving performance of subjects while intoxicated on cocaine, 100 percent of the subjects reported lapses of attention while driving enci ignoring relevar.t -

stimuli, such as changes in traffic signals (Siegel, 1987). Cocaine.t,an increase irritability, hyperexcitability, ar.c startle responses (Devis, IEEE; Seigel,1987). Sudden sounds, such as horns or sirens, caused violent responses in intoxicated subjects (i.e., rapid steering cr braking effects while driving an automobile).

Studies have demonstrated that cccaine intoxication interferes with tasks involving the acquisition of new tehavior patterns that require learning; cocaine intoxication causes performance 6ecrements in the acquisition cf new behevicr~ patterrs (Fischn.an, NIDA Research Monograph #50,1984). Inpairntnt in learr.ing has been evidenced in the first 10-15 minutes after intravenous administration of cccair.e; these effects are seen only 1r. the short-term immediately citer administration (Fischman 1984; Walsh,1987).

The belief that cocaine enhances work performance because Inca Indian workers chewed coca leaves and supposedly worked harder is not supported by recent

. 15- -

Enc 1csure A 9

J

-_= . _ -.

(,, ,

+

~

research. The~ subjective; perception of +orking: harder is;prescrt,,yet therr;is :

no measurablesimprover:ent-in per forniar.ce (Fischman, NICA Research Fcregr6pb y e ll#50/1984). "It should; be noted that curient routes cf administration j .

.(intravenous,Lnasal,. smoked)anddoseconcentrationsareit.uchmoreintes.sein

~

1 effects than chewing coca leaves ~and mdy preclude an accurate ccmparison other; .

\. .

U .than aneccotal-observations.

Tests which measured subje. cts' hanc'-grip strength end re4ction time, crcirL ti.e -

4 influence of cocaine:showea no.significant enhancenient 'or decrerrent. in j performance;(Fischman,NIDAResearchl'.onograph#50,'1984).

' Substantial data exist that demonstrate cocaine's similarities to amphetamines

~

in that performance in non-sleep deprivec subjects is l'eitter enhonced rer impaired with normal cosages; these drugs are effective, however, in returning

sleep-deprived subjects to pre-deprivaticr. performance levels. For example, inhalation of up to' 96 mg of cocairie alloud a sleep-c'eprived subject to; return

' to: pre-deprivation; performance levels' (Fischman, NIDA' Research Ponograph t50, 1984).

LCocaine' is often used with other drugs such as alcohol, opietes, or ChS '

depressants; this-polydrug use can uffect complex performance, bewever,

' specific performance effects have not been adequately stuoieo (Byck,1987).

Cocaine use with alcohol may mask alcohol's effects, i.e., a person may fccl sober and alert under the' influence of cocaire ano alcohcl though he -or she n.a,y te. significantly Impaired (Stone, et al. ,1984; Seigel,1987).

Cepression is symptomatic-of withdrawal or abstinence from cocaine ebuse. This is coupled with irritability, anxiety, hypersomnolence, episodic

.uncensciousress, and attentiorial dysfunction and ataxia during the initiil phase. ' Cocaine sn.cLers in one study reported impaired driving duririg this

-tirie; several were involved in separate collisiens resulting in irajcr injuries (Cawin arid Kleber,1986; Siegel,1987).

. 16 Er. closure A

_ . _ _ . _ . _ . - . ___-..___._.____..__________m_.__ . _ _ _ _ .___._______.__.m.___m_ _ _ _ _. _ _ _ _m.__.__ __ ____ _ ______

n.7 .

4 3.- Physical Signs of Abuse.

L Psychological) and behavioral syn.ptonis. of cocaine abuse ere n.arked by

. irritability, decreased or dysfunctional attention, restlessness, hypervigilance, paranoia,andhallucinations(Siegel,1987). Chronic or habitual use produces unacceptable irritability, paranoid and delusicnal-thinking,.and other unpleasant effects (Jones, NIDA Research tecnegroph e50, 1964). Cccaine psychosis may occur with prolcngcd high-dose cocaine use (Fischman,, t!IDA Research l'onograph #50,1964).

' Acute physical symptoms of ~cccaine use ir clude increasea blood pressure and

' heart rate, hypertensier, blurred visicn, increased muscle tensier, tremors, palpitations, slurred speech, dysarthria, thirst, anorexia, 93drisis, increaseo body temperature with sweating, headaches, dizziness, r.ausea, and diarrhtc (Siegel , 1967) .

4. Tolerance and Withdrawal.

Tolerance develops ouickly in cocaine users. The efiects en the central nervous system which are sought for the cocaine "high" are rapidly lessened in frecuent or regular cocaine users (Washion and Cold,1987). In a recent study, the subjective euphoric effect increased in intensity to a peak one hour after intravenous cocaine injection, then declined tcward the baseline at fcur hours despite the presence of ccnstant plasma cocaine levels. This repid tolerancc developn.ent is acute in persons who use cocaine on a regular basis. Tolerance development is quantified as an exponential process based on the finain9s of the study (Ambre, et al., 1988). This acute tolerance development accounts fcr the progressive alteration of the cccaine concentration /effect relationship in individuals (Ambre, et al., 1988).

Symptoms of withdrawal from cocaine can occur even with relctively high doses of cccaine still present in the user's system. Due to acute tolerence development, increasing the frequency or size of the doses fails to produce the desired effects. The euphoric cffects are consistently replaced by dysphoria and global sensations of " feeling bad" .( Ambre, et al. ,1988).

. 17 Enclosure A -

Withdrawal: fc11ct.ir.g complete cessation.of? cocaire- use is markeo by disturbance

'. er.d changes in sleep ratterns. .Cne st'udy suggests. thut these chor.ges are Linacecptely. explairaid by- the term ." psychological: dependence" (Jcr.es, fo1L/,

, :ResearchMonographfl50,1984). These withdrawal symptoms pose a stror.r, negative; incentive that makes it very cifficult to quit using cccaine as long  !

as the drug is available (Jones, !?IDA Research l'onograph f/50,1984;> Jones in PashtonandGolo,1507). Further 'use' followirig withdrawal can ' produce '

. irritability , . paranoia r delusional and confused thinkir.g, ard other unpleasant'  !

effects leading-to-o cycle of ceasing end resuming the use oi ccccine kncwn as- j

~ the~ ','run" . (Jones in Washtnn and Gcid,1957) . The nature of cocaine abuse in I

the workplace vill-presumably be cyclical within individuals over time (DuPont 3 in Washton and Gold, 3g07). l 1

~

~5. ' Discussion. '

I i

Acute tolerance development and severe and unpleasant withdrawal symptcns pose I a two-fold problem for cocair,e users: increasing amounts of cocaine are-reouired to maintain the euphoric "high" which beccmes harder tu achieve; and. l

. cessation of coceine use is a difficult and peitiful withdrawal process which casts serious doub'ts upon terming addiction to cocaine as merely " psychological dependence."

. l. cute tolerance develorn.ent hinders accurate studies of cocaine effects on ccgnitive.anc task performance. f6any single-dose sttdies hcVe been conducted, yet their applicability to regular users (e.g., multiplc use on a daily basis) is questionable. Coceine hos been much less stuaiec than other drugs of abuse such as marijuana or heroin. This is partly due to the pharmokinetics of the l drug itself, and partly due to the inattention given to the drug until the late.1970s, when cocaine became very popular.

Cocaine is a relatively fast-acting drug and is quickly metabolized and excreted from the bocy. Peak effects ere usually experienced IC to 20 minute after ingestion, and total effects lost no more than 40 to 50 ruinutt.s (Walsh and Ychay, 1987). Cocaine's effects are similar te arphetaraines in that it stimulates the CNS ano produces feelings of euphoria. It has been shown thtt ,

18 Enclosure A

,y ,

,fM - <

g, ; . 9 d cocaine [does r.ct sign 1fictntly enbarcec performance nor does .itc 61 ways create

-i.ignifictr.t performar.ce cecrericr.ts. in nernal' dus' ages, herever, areti. toiet tr.cc -

T Mhvelopment i definitely ccFplicates the concentration /crug effect equation',:

s

' making 1" normal" dosages and consequent. effects of cocaine difficult to define.

. Es withl amphetamines.j cocaine u'se appeurs to. return sleep-deprived subiects- to norrral pre-ceprivatieri performance levels.

Cocaine cabses partroia:and aggrcir,19ert.cs. Cocaire. abusers tenc toward

=

r

' 'v L violer.ce, suspiciousness,. cht.i pa:Lancle. There 'are serious irrplic6tiw+ fcr

. users of cocairtt in the.hurkplace'et all levels. Sccicl interectius u.

_ presun! ably worsened by' cucuire use. Cycliccl " runs" of cocaine 'use by u wor ker.

7 create withdrhwal Ord recurrent uss syn,ptors'such as irritebliity tid lessitude LfclloWso by the- previously trentior.ed symptoms of chronic usc.

Thus, while the

-irraeciate effects of the drug.on the central nervcus system trey nct r.tcosrcrily cause'impairnent,: the overall effects on the individual end his or hcr Jinteracticn with others are likely to create performance prcblems in the nuclear pct.cr pinnt sctting. The behavioral'cffects of coccine curir.g all

' phases of. use-- intoxication, hangover, dependence, and withdrewal-- directly dridsindirectly'impdCI performance. ,

C. Opiates Y

1. Background.

Opiates, or o'pioids, encomposs riatural drugs derived from the opium poppy and i' synthetic drugs.'that.posst.ss distinct chenicel structures, but sin.ilor pharmacological characteristics to natural- opium products. The te.rn. ,

' " narcotics." is used to cascribe this class of drugs (Voolf, in Bennctt, Vourakis, and Woolf, 1965).

1 4

Opioids'are used both for medical treatment ar.d personal (recreational) reasons. Opioios primarily affect the Central Nervous System (CLS). Opicids

. are cmong the'most effective drugs known to relieve rein. Connon effects 1 irclude mood changes, mental Rouding, or more ccmmonly, euphoria. Notural

.lcploid drugs include cpium, heroin, codeine, and morphine. Synthetic opioios 10 Enclosure A

\

_ _m. .-_m. _ _ _ _ _ _ , _ _ _ _ _

it.cluce by&omcrphcne (Cilaudid), cxyrrcrphct.e (fiurrorphen), oxycodone (in fcrcodan), hydrccocone (in Hycodan), rethadct.e, propoxyphene (Larvc6),

rreperidine (Den,erol), and other synthetic viriations. Though these various epicios have subtle differences in the duration of ef fccts, withdrawal' patterns, and abscrption, the pharmacologic characteristics of these drugs can be desc"ribed for the group as a whole (Woolf, in Sennett, Voerakis, and hccif, 1983). Cpioics are ingested intraver.cusly, orally, and by inhalotion.

Heroin is first among the top PU cents ollec' substances based on natiorel estiratcs of ene.rgency room trentict.s, e 100 percent increase since 1980; codeine con.binations arid Percadan (licit use) are listeo as 5th and 14th (Frank, 1987).

2. Effects on Ferformcr.ce.

There are trany known effects of cpiolos. Opioids produce mental clctding, promete faulty judgn.ent,. reduce hunger, induce feelings of euphoira, rec;ute the ability to concentrate, recuce sex drive, prooece drowsiness, procuce apatby, reduce activity, and reduce aggrsssive drives (Wecif, in Berett, yout utis, and boolf,1983).

Cognitive and psychornotor perfctnience are generally inpired by narcotic-like crugs, eithough the duration and extent of impairment r) pends on the type et opioid, the dose, end the experience ar.d oug histcry of the user. Ingestion of low to rroderate amounts produces a short-lived feeling of euphorie followed by e state of physical and trentoi relaxation which prsists fcr reveral betrs (Walsh and Yohoy, 1987).

Use of other drugs with opioids can produce cccitiu effects: corrtn ning alecbcl with opioids prcduces n.arkeo scdetica and respirotury depression due to the sedetive effects of these drugs on the CfS; this car leod to unconsciousness or death (koolf, in Bennett, Vcurokis, ard Mf,1983).

I h -

20 Enclosure A l

l l

3. Fhysical.Sicns of Abuse.

Opioid use tray produce sloe effects of drowsit.ess, constipatitti, vausea, vomiting, and orthostatic hypotension (Woolf, in Bennett, Vourchis, and Woolf, 1983).

Characterist',cs of crioic users include pupillary constrictier, depressico, apathy, or lethargy. Fit-like syrrptors are corrrron symptoms of opioid withdrawl, c.g., watery eyes, causec anc vcc.itir.c, muscle cremps, icss cf appetite, cnd other symptoms (Blum,1984).

4. Tolerance and Withdrawel.

Selective tolerar,ce may develcp with cpioid use; toleror.ce rnay develop to cce effect of an opioid but not to others (Woolf, in Bennett, Vcurakis, and Woolf, 1083). Tolerance decreases rapidly follcwing cessation of the drug. Chrcr.ic users may abstain from opioid use for short pericds of time to regain the "high" which they lost due to increaseo tolerar.ce.

All opicids are physically and psychologically addictive. All produce withcrcwal Lyrrptoms with ir.divicual differences in type and severity. The degree to which adciction occurs varies am:ng the opioids. Withdrewei s; w> ton i can be vinient. FJr instance, Withdrahcl frble mCIphine prOduCLs the fclirring syrrptors in crder el uurivy and progresstor. (4 to 10 weeks) af ter cettatico of drug use: rur:ny no.ea, extrere yawiing, nausea., vomiting, diarrhed, sweating, cold / hot flushes, eching joir.ts, muscles, and bones, tv;itchir.g tremor, muscle spesm, elevated temperature, goose flesh, dilatec pupils, blurred vision, high blood pressure, restlessness, anxiety, irritability, incressed respiration, and insomnia (Wcolf, in Ber.nett, Vourakis, end Vcolf, 19L5).

l If an crioid usa is occicted and tolertet of the effects of one cpioid, he er she will usually bt tolerant of another. If cne opioid is subst1tt:ted for the effects of another, then withdrawal syrrptoms will follow that of' the substitute crug. This phenorrencn is the basis for switching opicid addicts tc cpioios with less severe withorawal effects, such as methadcne, in order to detoxify the addict (Woolf, in f>ennett, Veurakis, ano Woolf,1983).

' 21 Enclosure A

-- - - - ~ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ , _ _ _ _ _ _ __

[ .

l

l. '5. D'i s cus sion. -

The cpioids are a large class cf drug primer 11y cerived from the pcppy. Opioid drugs are either natural or synthetic. Opicios affect CNS functions, primarily acting as a pain reliever, cr. in larger doses, a hallucinogen. Cognitive ano psychornotcr perforrrance are generally impaired during cpioid intoxication.

Opioids arc physically erd psychologically ac'dictive, with severe withdraal l symptcirs, c'uring abstention, lasting up to 4-10 weeks (Voolf, ir. Eer.nett, l

Vourakis, end Woolf,1985).

1 Particular attention should be given to licit use on the job of cpiold-based products, such 65 pain relievers or other prescription ano over-the-counter drugs . Suf ficier>t dosaces can irnpair cr.-the-job performance , especially v t en corrbir4c with other drugs tuch as alcohol. (Poskowitz,1985).

D. Phencyclidine

1. Background.

Phencyclidine, correonly known as 7 "P, was first introduced in 1957. It is ncw a n.6jer drug of abuse ano is lis%d as 8th artcng the top 20 controlled subs?.ancS. based cn r.ational estimates of emergency room mentions (irank, 1987). TCP bcs a variety ci effects on the central nervous system (CNS),

n;aking an adequate classific6tien of the drug difficult.. It is best understood <

u a hallucinogen (Holtreck, in 8?ent.ett., 'vourt.his, and Woolf,1963). PCP can cause CU stimulation anc cepressicn with a great deal of variability A.penoing upco the cose and type of PCP. PCF intoxication begins several roinutes after ingestion of the drug and usually 16sts up to G hours or more (balsh uc Yohay, 1987). PCP it vell known for producing unpredictable side effects folltwim intoxication, such as ert.ergence psychosis or fits of agitation cr excitutsility.

Intoxication in low doses of 5 to 20 n.g of PCP resembles an acute confused state (Marwah and Pitts, NIDA Research horeograph #64,1906). higher doses in excess of 20 mg car. f. licit serious neurclogicai, cerd.iovascular, and psychotic reactions. In fact, PCP-induced psychosis is siniilar in effects to clinical schizophrenic (Marwah ar,o Pitts, NIDA Research Nonograph #64,1986).

22 Enclosure A

)

1

Q There~have been relatisely few studies cn the be.havicral effects or PCP on hurnans cue to the pharmckinetic aspects of the crug and the volatility a.c

. unpredictability of the side effects of PCP. Alsc, PCP's pcpularity as a drug of abuse is relatively recent. However, there are sufficient clinical studies, criminal cases, and behavioral observations that conclusively demonstrate PCP's erratic and severe behavicral effects.

2. Effects en Performance.

The behavicral effects associated with PCP use are variable and cften cependent

'upon both the perscn end the environment. Clinical studies have icentified four phases of PCP abuse that r.ay appear in successive stages. The first ptose is terned acute PCP tcxicity. Pehavicral effects include ccmbetiveness, 1 catatonia, convulsions, and coma, all of which are dcse related. V1suul disturbances, particularly distorticr of size, shape, 6r.d c.1ttance percepticn are ccmon. The first phase tray last up to 72 hcurs. The second phcsc is characterized by grand mal seizures, ceria, and death due to respirc *ry depressicn following sufficier:tly high doses. The secono phase may last up to 7 days or longer. The thirc phase is characterized by schizophrenia which r.ioy last a month or longer. The fcurth' phase is characterized by PCP-induceo depression, especially serious due to the high likelihood of suicide at this time (Polbrook, in Bennett, Vourakis, ano Woolf, '.983). Performance impairment at any of these.ievels is highly probable. Clinital ccses have decomcstvo the severe. debilitating physical and psychoicsical ef'ects of PCP abse anc the ..

extremely urpredicteble behavioral ef fects that the drug causes. Persons un& r

(

the influence of PCP My pac:pitate life-threatening situt tions due to the disorienting and bzliucinogeaic effects of PD intoxication CMt.reck, in Bennett, Votr6kis, and Wocif,1983).

Studies have derronstrateo that FCP can also elicit behavicral effects la users similar tc barbiturates or other sedative / anesthetics (Balster, f:ICA Research lAcrcgraph#64,1986). It is obvious that heavy users cf FCp would exhibit

j. matcr signs of intcxicaticn. Task performance requiring motor cccrdinaticri, such as driving ar automobile, would be significar.tly disrupted by FCP (Balster, NICA Pesearch Monograph #64, 1986). In fact, several fatal accidents 23 Enclosure A 1:

1 o_z _

L frvolving FCP-ir.toxicated drivers highlighted severe cccrciraiticn irrpeirnent, acute confusional state, and cn inability cf the intoxicated driver tc thiid P abstractly or make ratics:a1 decisions (Lerner und Burns, NICA Fesearci.

Monograph #64,1986).

In conibination, PCP sigreific6ntly enhances the e.ffects cf classical c'e.pressant drugs, inclucirig barbiturates anu ethanol (Belster ano Kessirger,1983; Balster, AIDA Research For:cerath W64, IEEE). Use of PCP with other depresteris such as alcchol is a potentially lethal ccn.binaticn which has ar. acc;ictm.

effect en PCP interication, cr.d rray explain son,e behavicral cbservdi. ions cf FCP intoxication (Palster , LIDA Research Monograph 4E4, 1986).

FCP Lset s have reportt.d uniciue intcxicetirg etfects of the drug urlikt. that of other drugs of abuse. Powever, self-acn. ministration stboies of FCP reveal thct patti.:ns of abuse are similcr to barbiturate and alcchcl abuse: dosage intate is sufficiently high to cause r.iarkec' behavicral effects (Ec1 ster, fMPA Pesearch Ponograph 564, 19E6).

3. Physical Signs of Abuse.

PCP intoxic.ation is trarked by difficulties in coordination; severe confusian) or agit4ted state; inexplicable mced changes betweer, lessitude and cxtrenie agitation; nzods such as suspicion, ancer, or terror; ard erratic or vicient actions (Belster, f:IM Research P.cnograph r64,1986; Holbrook, 3r. Serinett, lletrakia, arid Kcoif,1983).

4. Tolerance end Withdrawi;1.

Anin.a1 studies hcve clearly determined icierer.ce develeprent felinwing continuchs use of PCP (Balster, LICA Resi. orch Pcnograph 464, IgEC). Tolerance develops in human subjects with niiloly frequent (daily) use (Holbrook, in faennett, Veurakis, and Koolf, 19P?), althcugh long-tcrm implications are i.ct yet fully urderstood (Jain, et al., 1977; Marwah and Pitts, NIDA Fesearch Monograph #64, 1986).

. 24 Enclosure A

c 1

+

s:

b .'Anisal studies / uve h shown dratratic withcr&wal. symptoir.s following. the

teru.inaticr. cf PCP use, such as vocalirstiens; hyperactivity; 16ssitude;

.trenors; and,'in one case, ccrivulsions (Balster, h1Lk Reseorch Monograph h64, p 1986). These symptoms appeared withis S hours of abstinence and were mest severe at 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> (Balster, NICA Research Vonograph #64,1986). PCP haslnot been reported to produce phy:.ical oependence even with chtcr.ic use in humans. )

Fewever, psychological depenoence is reported frequeritly aircng chronic users.

-similar tc the rate of tolerar:ce develupnier.t (Holbreck in Ct.r.nett, Vcerakis, andLVcoif,1502).

j '

5. 'Discession.-

PCP is a ccirplex bellucinogenic drug with diverse, and often darterous.ot ']

lethal, bellavicral effects en hunions. The understar. ding of FCP's physiolcpic cand psychologic effects on h ans is still relatively r.ew. It is well known,-

Fewever, that FCP is'dri cresually dangerous psychoactive substance with j 6 predictable behavior 61 effects. j

. j Long-terra adverse health effects of PCP use are significant. . Irreversible n.errory loss, perscnolity chenges, and thought oiscrders have been docuriiented. . )

Sponter.ccus recurres.ces of crug effects (flashbacks) are possible. humerous .i

. 7_

fctalitles due to PCP intoxichtico h6ve been documentec (Walsh and Yohay, {

1087). Obviously, these characteristics of PCP intoxics. tion, chronic use, and l, \

withercwal have sericus. job performance implications. It may te assun:eo thac l t.ry use of PCP will significantly impair the abuser's short-term, ano perhaps j.

traanent ccgnitive and task performance.

I E. Anpbetarijnes

1. Backgrouro, i

- Arnptetatiiries are central nervous system (CNS) stir;.ulants. The term

" amphetamine" is 9t.neri.c and applies to the group of synthetic cou.pcurds derivea f~ rom ephedrine (Helbrook in Bennett, Voerckis, and Kcoif,1983).

Examples of connon trade name arrphetaniines are Benzedrine (racemic j

.- 25 Enclosure A 0

-____m___.__m.__ __.m_-_ .__.__.______.m.__.. _ ,_m

1 >

'9- q

. 1 arrphetamine);; Cexecrine (dextroamphetaniine); and Desexyn (nethaniphetamine).

The.behavicral effects cf amphetamines are similcr to cccaine; hewever,:the thc types.of stirrulant: differ in that arrphetamines have a longer du'r ation ef . j

' behavioral effect'and grea'.er toxicity than cccaine (Holbrook; see Bennett, )

-1

-Vcurakis and k' coif,- 1983). . . Amphetamines are fcund .in licit ar.d illicit form.

~

l j

-In general, amphetamines stirc,ulate pulse; heart beat; bleed pressure; respireticn; perspiration;. ano, et higher deses, increase bcdy temperature anu basal metabolism (Caldwell..-19PO).

E. Effects on Performance.

'l Amphetamines are widely used to increase ciertness and fight fatigue. Studies -

have shown that ir,' therapeutic doses, airphetori.it.es increase ciertness, decrease

-fatigue, elevate mood, and frecuently produce euphoria. Motor activity is - -l increased anc' physical performance of simple tasks is improved. Sleep patterns j g are disturbed and total sleep time is decreased (Holbrock in Cecr.ett, Voorakis, ar.c k' coif,1983). Users 1cf small doses experience e heightened sense of well-being', sharp attentiver.ess, an increased acuity cf reflexes, anc idealiz'ation.(Caldwell,1980).

The effects of amphetariines en cognitive ar.c. task pyrformte.te are well

, documented. -Amphetamines improve short-term physical performance in a variety o

L cf- areas, such as vigilence perforir,ance (the ability to attend to senscry j L inpur); niotcr perforrnance (swimming, running, etc.); learning or accuisitinn of l L mater skills; and reaction time. k'ith contr611ed deses, the auverte effect.; cn L physical performance were niinimal (NUREG/CR-3916,1983). Simpie short-terrr.

r.ognitive performance, such as performing repetitive tasks which elicit fctigue cr' boredom; simp 1= rath tests; verbal sbility tests; learning of visual infctnetion; and enhanced chility tc read and understand 6 fcreign lutregt. )

improves with centrolled coses (NUREG/CFi-3196,15E3). Tests nf cctnitive-tasks  ;

reodiring relatively frore complex skills stch as calculus cid not shcw performance changes under the influence of an.phetamines (NUREG/CR-3196,1983).

High doses of amphetamines, however, produce experiences of an exagguated sense of well-being, high energy, restlessness, urgency, overideation, ar.d gross-temporal distortion (Caldwell, 1580).

. 26 Enclosure A

L Cccnitin and: task perforr.:ance decrerents due to an.phttnire use en a' regular

basis-~are highly 11kely:: " runs" or cycles sin'iler to cocaine runs of abuse and cbstinence arc also characteristic of arephetaraine abuse. Echcvioral effects L cue.to these cycles of, abuse would directly impact cognitive and task l

_ perforn.ance.; Secondary effects of arrphetamine abuse such as hangovers, rebctr.d depressions. anc insomnia directly irnpact cognitive and task perforn,ance.

Inpretamine abuse emorig. truck drivers is c.itec esz ccc example (Calowell,1980).

s Because of. acute tolercr,ce_ oevelcrrrent, there cre ieher performar.ce Gerer,itr.ts experienced by regular users of cirphetan.ines than by initial users. One study revected, hcwever, that after the establishment of chronic tolerarce ar.d .

sustained drug levels throughcut a 24-hcur period, drug cessotion' procuced ste following performance effects: pcrforrcance impairrrent inititil) cecreased as the drug itsel in the subje.ct declined, fclichec by increased irrptirn.ent es the adverse effects of drug ~ withdrawal - byperexcitability and/or delirjuni -

appeared (Ellinwooo ar.d Nikaido,1987).

1 3. Physical Signs of Abuse. ,

kith 'high doses', gastrointestinal- function may be altered, and naused, vomiting, ciarrhea, and crar. ping nioy eccur.- Cardiovascular signs of heavy use include- hcadache, hypertension, pullcr, and palpitation. ChS signs ,of heavy use include hyperreflexia, restlessness, talkativeness, insomnia, violence, cr.d increast4 libioo. (Cal 6 ell,- ICEO). high dcses may result it; an.phethnine:

psf chocis, which resu.bies a true parancia schizopbr;criia in the clinical sense.

Ar9h etarr.ine 6ddiction is probable with continued or frec, vent use (Helbrook in Pennett, Veurakis, anc roolf,1983).

Evicence of stiollart intoxv ation in tre forr. of hyperexcit/bility tr L ceteriorcticn of driving skills occurs with increasing deses (LTfirwocc enc i N_ikaido',1987). Aggression and violenca dre pctential side effects cf higher doses of stimulants. Highly toxic dcses con incuce hallucination, oelirium, enc celusions (Ellinwecc,1971; Ellinwocd and liikaloo,1987).

27 Enclosure A r i istsi - - . . . . .. . . . . _ . , _ _ , _ . . _ . . _ _

4

4. Tolerance end llithdrawal.

Similar tc cocaine, amphetamirie tclerance cevelopirent is rup10 (Caldwell, 1980). Chronic use of the airphetanInes leads to development of a tolerance for the stimulant and appetite-sLpiressent effects of amphetamines, evui when ac' ministered ir low therapeutic dvses. Chronic abuse leech te high tolerance (Holbroek in Benr.ett, Voorakis, uso kuolf, J PP2).

hrphetemines a*e psycholegicelly acoittive. Though nc physicar witheraval syniptoms cccur follwir.9 abrupt disecrtinuction of use, psychologic changer.,

such as apathy, long periods of sleep, irritability, cepression, and hvorientation, may be prominert for several merths. parercio n.a) fcilcv tFe first seven cays of withdrawal fellchit 9 the cbrupt retraticn 01 heau use:

delusions may pers'st for up to a year (Folbreck in Lennett, Veurakis, er c' k' col f, .1983) .

5. Discussion.

Amphetamines stiri.ulate the CNS dnd cardiovascular system. Shcrt-term prysical and s'imple ccgnitivt task perfortrance is heightened to a minor cegree by the use of aniphetamines. Corrplex cognitive task perforniance is cet heighter eu by the use of errphetamir,es. Sn.all cr.d noderate dcses of amphetamines errance cognitive arr task performance on specific ar.c siirple tasks, SLch as vigilance cod psychonotcr sMlis, hit these perfctr,.ance enhancerrent cf fects decrease considerctly as the compNity of the task incruses (Ellinwccd and Nikolco, 1987). Si;ntficanc performance decrements occur as a ret. ult of ecute tolsrance developtrmt, hangover effects, anc withdrawal svrtuna. Thus , trany short-ta nt gains 9 cegaitivt ano tz.sk performance are ouweighed by the adverse {

performance effects che to regular use of amphetar.iries ard its bf eb ic tental for abure.

l J

Secondary effects of ampnetuniine abuse such as " runs" and withersuc1 "crcshes" may adversely affect cognitive ano tusk perforrrance. The high abuse poter tial of amphetarnines may lead to addiction if used on a frecutrit basis. Chrcnic '

l users of artphetamir.es are likely to develop tolerance to the Ch5 effects of 1

i

, 28 Enclosure A l

l

airphetamines cs well as psychological dependence. Withcrawal syn:ptoms are psychclcgical and produci- a ver'1ety of adverse behaviu al effects which directly 'mpact ccgniti u crd task performance. Similar to cocaine abuse, the nature of snphatamine 6buse in the workplace will presumably be cyclical within individuals over time (Hurst. 1987).

F. Summary Use of any of the itse listed drugs in the preceding discussion car. dire ctly a

and indirectly affect or irpe1r on-the-jcb perforrur:ce thicuch intericaticn, hangover, dependence, or withdrawal effects.

Emphcsis sbculd be placed upon exeminire all phases cf drug use in th.

workplice, since drug-seeking behavicr, administiutien, acute and chtonic intoxication, hangover, and withdrawul phases of drug usage tray all have detrin, ental effects on individuul end team performance (Walsh,1987).

The present ubility tc predict the behavioral . consequences ci drug use is limited; the ability to accurately predict the specific behavicral performance

.cf an individual under the irifluence of a certeln drbg is minimal (Walsh, 1967).

One appliceble measure of drug-induced impairment in the nuclear inctstry may be injury rates. As one researcher states, "A conscn but incorrplete and pccrly understood thread that passes through injury repsrts is the fregttrcy with wnich alcohd and drugs are involveo" (Walsh, 1987).

A multiplicity of variables corr.licates the drug dosage /impairr.ent-celetictshp: the type and poter.cy of the drug, patterns 01 consumption, the Odiv%al's physical erd psycholoc) cal chsracteristica, the envircorrent in which Ole drag is used, and group interottion. McVevcr three generalizations may be made re.9araing the drug dosage /impairnent relaticiship: higF deses gererally have greeter behavicral effects then low doses, well-learned tesks are less affected by drugs than novel tasks, and irotivaticn regardinc the task is an important factor (Walsh, 1987). Further, the studies conclusively demonstrate certain behavioral effects of drug use that impair the user in a variety of ccgnitive, task, psychological, and social performance areas.

l 29 Enclosure A l

L_ _ _ __ _

J3 .

A clear; relationship has been cen4rtstrated among orug _use (nonspecific

[:n .. _

. . . dosage), sereral behavicral f cffects, ar d' impairnent.- It is ebsicus from the

.rcsearch that use of'ariy of.these five crugs or types of drugs alune or in .

' combination has the' overwhelming potential to impair workers in the, performarice of their.' cuties. The question is r.ct whether drugs in. pair performance, but how theyldo-so under given circumstances.

II.. Alterretives'to urinalysis.

The Consission ' considered techniques for arealizing' blood, breath, saliva,

- fingernails, ofic broinwave patterns and cericluded that there is no viable sub.titute for urinalysis it. the riear' future, either technically er practically.

.A'. Analysis of Bicod Plasma.

The analysis of. blood has some significant advantages over 6rinalysis. The main. advantage is-that there is a much acre direct relationship b6 tween blood levels of-e drug and'impeirnient, since levels in the blocc are more directly -

reflective of ' effects on the CNS. In the ' case of alccbol, of ceurse, lepi"

-limits: defining picbable impairrrer.t have be.ur, estchlished in state law.

Equivalent standards for other drugs are not ger.erally available, but an

. analysis of bl6cc can identify the extreme cases where there is r.o coubt of impairment, however, current data is insufficient to est6blish cutoff levels to distinguish between impaireo and unimpaired indivicLals (Consensus Repurt, hov. 8, 1985). Bleed tests are useful in pcst-accident analyses if the subjects can b6 saepted quickly. Another minor davantage cf blood testing is thet tests can uwcily deel directly with the drug of interest, rather then one cf its metabolites (in urine), und n1ay thus avoid sorte cf the prchlems with crossreaction.El

-1/ Cross reaction occurs when a substurece other than the drug cr drug i metabolite being tested fcr ir, a specimen creates a positivo test result.  !

. 30 Enclosure A 1

Tbcre are probitas with testing blood cr plasma, towever. One of the most significar.t is the higher level of intrusive: Ass (Cogcloff and tr.garcia, 1965). . The drawing of biccd it volves pain and trauma for scce; concern atcut AIDS would heighten the anxiety, thcugh unreasonably. The collection cf samples would be rnure expensive, rec;uiring trained fredical personriel (Walsh and Ychay,1987).

There are also particular substerces, such as cocair:e, with such a short half-life in the tit ed that the chances of ic'entifying eret s thrcugh bleed tests are substantially reduced (lishten and Cnid, IEE7). Alsc, the concentration of iretabolites in urire is scnietirrcs higher than the concentration of the drug in plarnt, as in thc. case of amphetamities (f;elter ard Foffat1980,iriSiph._teminesard,Re,la,teaStimulants)andccceirt 3 (l;osht.un and Gcid,1987). In general, drugs and their metabolites car. Le identified c ur a lenger pericd cf t1rne through uriralysis (Washton and Gold,1g87).

C. Analysis of Salive.

The analysis of saliva is receiving considerable attention. Radioitun'ur.cassay (F.IA) proccdures for testing saliva exist; also there is a cor..nercial kit dvailable for testing sdliVd. If technically feasible, tie use of saliVE w0uld avoid some of the intrusiveness and cabarrassment of urinalysis. While clinical studies using seliva have been conducted for o number of yeers (Cucdy, 1984), saliva testing currently coes not represent a viable alternative to urinalysis (Walsh and Yohay, 1987). Analyses of saliva fer purposes of detecting marijuana use, for exenple, have found that such things as food l consumption ano mode of ingestion can dramatically affect the ability of asseys I l

tc. detect marijuana use (Kwks,1982). Also, there is rarely a large enough volune cf trecimen fe', confirn.atice ; orpcsar.

l C. Anelysis of Hair.

l Cte drug testing technique involves the use of hair. hair can be used to I identify where there has been a past history of cfrug use. In fact, it c.in provide information en drug use over a much longer period than can urinalysis

. 31 Enclosure A L

f l

L .- _ _ _ - - - _ _ _ _ - - - _ _ _ _ - _ ___ . _ _ _ _ _ _ _ _ _

I I

s (Paumgartner, Black, Jones,'and Blahs,u1982)u Hcwever, "hai : analysis has notn l bien yhlidated extensively enough in clinical stuoies lto make an adecucte.

-'assessn.ent of its suitability fcr' general' drug ' screening. (Walsh and Yohay, 1987)." _(Puschel, Thomasch, and Arnold 1983).- This is a ver] expensive test, which would prohibit its use' for a large volume of tests, especially the

. initial screening tests. A more appropriate application n.ay be for diagresis

. of te patient's. drug histnry- to cesign the prcper treatment.

0.4 Analysis ci Speech..

Another technique involves the analysis of speech to determine the state cf a person's intoxication. Since drugs affcct the neurotransmitters ano receptors in thc' brain, the spes.ch of the clcchol or drug t.ser 1s affected acccrcingiy.

Th'e measure of' impairment ,is cerived from the time and freq6eccy of spoker.

numerical digits. This technique is intenced. to be a measure of impairnent of.

a ' subject at' the tin.e'cf examination, ano shculd avoid challenges based on invasion of' privacy. . It is not a test- for prior use of drugs where measurable-impairment.no longer exists. -Since the impairing effects of drugs are usually of briefer. duration than the detectable levels in urine, the opportunities fcr oetection of drug use are sontwhat less than with urinalysis.

E. . Analysis of-Qther' Specimens.

Other techniques are at the experimental or developmental stages. For example, breathalizers are being develo,ned for testing for marijuana smoking.

' Generalized tests are being aeveloped for body fluids ranging from sweat to mucous from the eyes. Techniques are being developec to analyze brainwave

. patterns and creasure eye movement. Analysis of fingernails is clso being censidered. hwever, a review ci the literature irdicates that the technical basis W.es wat yrt exist to suppcrt a legally defensible, wioe scale use of thesef techniques tither for screening or confirmatory purposes. Since urir;alystt testing appear:. feasible in the short run, other techniover, will not te considered at this tirae. The Commission will continue to monitor developments in other testing technologies tc determine when and if they offer an improvement over urinalysis.

32 Enclosure A

3 c .

a

III. Random Testino and Alternatives.

Kancom testing (unannounced crug' testing ir/pcsea in a statistically ranccrc tranner) serves two purposes: detectico and deterrence. It wculd appear that-any form of _ unannounced n testing that'would be administered so that a' persun -

completing .u test is irrrediately eligible for another unannounced test wculd satisfy criteris: fcr deterrence. Several potential siternatives were censioered, including employee 6wareress, other types of testing (reemployment, onncunced periodic, f or-cause, etc.), relience on behavioral observsticns and the Employee /ssistance Program, vurious security treasures, and combinations of these alternatives. L Gne goal of the Comission in proposing this rule is to bring at' cut a nuclear l power pient workplace free trom the effects of drugs. Such a workplace wculo ensure, to a large measure, that impairment of function frcm crug use would not adversely affect the sefety of nuclear pour plant operaticns. A workplace

~

free from the effects of' drug use would.also help assure thc reliability et-the nucleer power plant workforce to properly perform activities that require-scrupulous adherence to rules and.precedures. Random testing is a proven effective means of achieving this goal. The Corrmission concludes that unannounced ranoom testing is a strcng oeterrent to drug use, is u necessary element of an effective fitness-for-duty program, and that no alternative or combination cf alternatives would provide an acceptable level of both detection anc deterrence.

Systematic data on the effic.iency of random testing arc cnly availtble from the various programs implemented by the Departirent of Defense. Illicit drug use in the Army has been reported as cropping.from 7.9 percent-1n 1960 to 11.5 percent in 1906 (Raezer, 19E7). In the flavy, rates have been reported to have cropped trc!:. 47 percent in 1981 to ..rcur.d 4 EMent in 1566 (cited in (f. EN; June, 1986), Pates amor.g U S. Coast Gu6rd perwenel are down from 10 percert in 1983 to 3 percent in E86: this decrea.a is attributed tn a rer.6cm drug testing

[ . program (Eureau of National Mfairs,100/). In all three c/.ses, the reducticn wds measured by the rdits Of Confirmed positive tests during random drug testing, ard the observed decrease in rates followed the .irrplerrentaticn of the L . 33 Enclosure A L

_ - _ _ - _ _ _ . _- = _ _ _ 1

irandom drug testing progran..- Tbis. pattern isiconsistent with what would be expected if ranc' car crug testir.g +cs to havc_ a strong ceterrent-offect.

Althcugh other factors,.such es . drug educatico progrcms, negative press-

. associated with drug abuse, stringent disciplinary action, and better selection -

9 (hiring) process,may'beaffectingtheresults,6vailabledataindicatethere are substantial . rec'uctions in drug use asscciated with the implencntation cf a random drug testing program.

g

.The D(partment cf Transportetton'(D0T) has been the leading federal acercy in, iniplementing drug testing prcgrams for private- setter employees stt.fect tu federal regulatery jurisdiction. None of the ager,cies in the Departh,ent

. currently requires random drug or alcohol testing of private sectcr employees,

but rLch requirements are beiL9 dClitely Considered through propnSed i irulemaking.

'The Federal R611t040 Administration (FRA)'hos cetailed regulations covering alcohol and drug use by railroad employees whose working hcurs are regulated under the Hours of Service Act (15 U.S.C. 61). Under the provisiens of 49 CTR Part .219, employees are prchib1ted from using, possessing, or being' impaired by a'lcohol or centrolled substances while on outy. Blood and urine samples of-employees'1nvolved in railrcad accioents are to be taken ono preserved.

Railroad cornpanies may reouire breath or urine tests frcni employees when there is reasonable ~ cause for suspecting prohibitec use of alcohol cr crugs.

Railroads are required to administer a drug test to new Employees coverta uncer the-Act.

The Feoeral Highway Administration (FHA) prohibits 1riterstate ccmmercial trbck .

. drivers frcm using amphetamines, narcotics, or any habit-forming druos, nr,c also reevires thot they have no current clinical diacresis of alcoholism (do CFR-391.41). fha is prepr. ring a rctice of proposed rulemaking that will propose e comprehensive drug centrol p'regram applicable to all drivers in interstate cortcerce (St.e. entry in l'nifieo Agence of Federal Peguletict.t published en October 26, 1987; S2 #R 40630).

I1 34 Enclosure A

l The- Federal Aviaticn kn: ministration (FAA) :rnhibits flight crewmen.bers from l heing unoer the influence of alcohcl or drugs. Tests n.ust be taker withiri fet r hours of acting as a crewmember when there is reasuneble besis tc suspect a violation. The FAA has suggested that randen. and scheduled drug and clcohol testing may be rieeded for flight ano certain ground crewniembers to protect the public safety (December 9, 19PC; 51 FR 44433). A D0T proposed rule that would require rardon, testing 01' airline errployees involud in flight crerations dr.d u.aintenance has been published in the Federal kegister (53 FR 82PE).

The U.S. Ctest Guard (USCG) is the primary n4eritin.e law enforcerrent acer.cy ior the U.S. It has proposed regulations prohibiting creration of a vesscl vbile intoxicated (February 9, 1987; 52 FR 4M 6). Fcr connercial operators.  ;

i intoxication is defined to be .04 percent by veight or rcre alcotcl in the l blood or when the effect of alcohol or ar. illegi1 drug on the cperators' i;anner cr behuvior is apparent. For recreational creraters, the cnly differe::ce is that tl.e applicable percentage is 0.2 percent. Tr.e LSCG 1s preparinc a rotice of proposed rulemaking covering usc of corigercus drugs by r:ertherit starf r'e personnel. The cption being censicerec is a requirerrent that individuals applying for licenses, certificates of registry, anc therchar,t trerirer's occuments provide the results of drug tests before issuance or reraal (he entry in Unified Acer.ca of Feceral Regulations publishec' cn October 26,19M; 52 FR 40562). The proposal also aooresses the need for rondom crug testing.

The pctential alternatives to rancoisi unannounced drug tetung are trany and varied. They include the folicveing:

Take no altern6tive action; Testirig before errployment or badging; j Feriodic drug testing (Er.ncunced testir.9)

"Foi-ccuse" drug testing Eehaviora! Observation Program j Medichi Screening )

1

• Employee Assistance Procrams (EAFs) i Access Authorization Prograni

. 35 Enclosure A l

_ _ _ _ _ . _ _ _ _ _ _ _ . _ _ _ _ _ _ _ l

Workplace security measures and Employee awarer.ess and education prcgrams.

Although systematic data dc not exist to compare the efficacy of these approaches, the literature and the f1huings of the staff's data-gathering activities de suggest scc.e advantages and disacventages fcr each. These'are oiscussed below:

A. . Take ho Alterr.ative Acticn.

The first alternative to randcm drug testing tc be considered is to teke f.o alternative action. This is cledrly nct a viable alternative. Stetistics available on c' rug use in the workplace incicate that a sigt.ificer t niricrity of workers have or cre currently abusing crugs or alcchel in the workplace (Neuner,1985). While the exact statistics vcry from ore. source tc another, a n.1dule range estimete is thot approximately 10-E5 percent of American wur kers abuse drugs and alcohol in the workplace. bh11e the incider.ce of drug abuse in the ruclear industry can be expectea to be lower, based in part on the existing security measures at power plant sites and the relath ely eggressive fitness-fcr-cuty prcgrams that characterize the industry, the potertial for drug abuse still' exists. The fact that 'epproyir.;ately two-thirds of the power plant licensees have not implemer+ad rancom testing programs, some because of union ir:ter vention cr prohibition .j State laws, suggcsts that significant reductions in the abuse of drugs by nuclear utility employees coula be realized when the preventive and deterrent effects ci industry-wide random testing programs are re alizeo.

B. Testing Eefore Employment or Badging.

Tt. sting befcre employment or booging is conducted by raony employers tc cr.sur e thot indiv1cuals who cannot reet fitness-for-duty standaros ere nct placed into ..

i sensitive ,iobs. Ccnsidereo by it.dustry as the fitst line of prctecticn ugainst ]

crug problems, reemployment testing is specifically used to detect and l l

' identify the nature of drug use, if dny, by job applicants, and to identify abusers prior to hiring. Although screening has focused on drug abuse, most

]

. 36 Enclosure A

large iadustrial companies now include tests for alcohol as part of prcemployment testing (Willette, 1986). Individuals with positive results generally do not receive further consideration for employment (McClellan, 1984). Reemployment testing is currently the most prevalent type of drug  !

{

L testing (Hanson, 1986). Virtually every nuclear power utility currently employs this type of testing.

Reemployment testing has some disadvantages. As a part of a company's hiring policy, it will certainly be known to most applicents. This knowledge removes any element of surprise, essentially making it an announced test and, therefore, allows applicants to be prepared for the test. A sophisticated or

" street smart" drug abuser may be able to ovoio detection, and less frequent users may be likely to abstain long encugh to guarantee a "cleun" sample. New .

testing techniques are in the process of being developed that may be capable of identifying previous (several months) drug use. However, these techniques hdve not yet been refined. Consequently, the ability of reemployment testing tc detect substance abusers currently is limited, Even so, licensees report that, typically, 5 percent or more of applicants for employment or ur. escorted access to a power reactor are tested positive.

The primary disadvantage to using reemployment testing as an alternative to random drug testing is that it in no way addresses substance abuse or dependency problems dmong the workforce subsequent to employment. Applicants who pass the reemployment testing and become employees may never face testing again. The deterrence factor, implicit in random drug testing programs, is absent. Reemployment testing is probably most effective when it is directed to keeping individuals currently experiencing chemical dependency out of the workforce, and is thus a necessary part of a total fitness-for-duty program but is not sufficient in itself.

C. Periodic Drug Testing (Annuunced Testing).

Periodic Testing appears to have few, if any, advantages over random cestino.

Periodic testing, whether announced or unannounced, mdy be perceived by employees as less discriminatory than random testing in that, on a given date 37 Enclosure A

all available employees are tested.' In a random testing program, some.

employees are selected at random and tested. Because it may be impractical to test. the entire body of employees on any given day, utilities may ' opt to use a random testing program. Under random testing, some employees may

~

coincidentally be tested more frequently than others, and the' utility may be required to prove that the selection process is truly random in response to a legal. challenge. If testing is announced and scheduled at regular intervals, however, all employees would be tested equally, at least theoretically.

.Further, if selection for random testing is truly random, an employee could, strictly through chance, not be . selected for testing for an extended period of time. As a result, employees with substance abuse problems may not be detected in a timely manner, ano their abuse problems may increase in severity be,ftre they are detected in the random testing program or the behavioral observation program. Periodic testing could ensure that all employees are tested with adequate frequency.

Should the testing be announced, immediate, pronounced disciplinary action could be taken without concern that the action is inappropriately severe, because any employee who cannot remain drug- or alcohol-free for an announced test has a severe substance abuse problem and an obvicus disregard for the safety of the public, co-workers, and self.

It is apparent that announced, periodic tests would not identify some drug

. abusers that periodic or random unannounced testing would identify, and that the deterrent value of announced testing would only be short-term. Announced, periodic testing would be less effective in detecting abuse of drugs that are rapidly metabolized, such as cocaine. It is expected, however, that an announced, periodic program Would identify some regular users of prescription drugs, and ~ users of slowly metabolized drugs such as marijuana. Because

~

announced, periodic testing wculd potentially allow many employees who abuse drugs to escape detection, it seems clear that announced tests would be less effective than random tests at identifying and deterring the occasional drug users. None of the industries surveyed in NRC's review of other regulated industries or those described in literature have adopted this approach.

.. 38 Enclosure A

y

~

l D. For-cause Drug' Testing. i A for-cause testing program has several positive features. In a properly implemented program, when there is cause for a supervisor or co-worker to.

suspect that an employee is unfit or the employee has been involved in an on-the-job acciderit, the employee is given a complete physical examination which includes drug testing. This examination may identify health problems other than drug abuse that have diminished the emoloyee's ability to perform safety-related responsibilities. The examination can also include testing for legal drugs of potential abuse, such as alcohol, over-the-counter drugs, and.

prescription drugs.

A ior-cause program Play have fewer legal problems than a random testirg prograu because there is a specific reasonable cause for the individual test. In a random testing program, the legal justification is that there is a possibility that impaired employees are present who represent a potential risk to the safety of themselves, their co-workers, or the public. However, when a for-cause test is conducted, the employee in question prese.sts an individualized suspicion of illegal conduct. Further, if the motivation for testing is the investigation of an accident, the utility has a clear responsibility to do everything possible to identify the cause of the accident to ensure that similar accidents are prevented in the future. There is a body of legal precedent in support of for-cause testing from various industries with safety concerns, including railroads, transportation companies, and the aviation industry, i

Some of the leading cases supporting for-cause testing include: Schmerber v.

California, 384 U.S. 757 (1966), (blood tests for alcohol on drunk ariving  ;

arrest); Division 241 Amalgamated Transit Union v. Suscy. 5?C F. 2d. 126a (7th Cir.1976), cert. denied, 429 U.S.1029, (blood and urine testing of bus -

drivers after an accident upheld);' Shoemaker v. Handel, 795 F. 2d 1136 (3rd g /f I Cir.), cert. denied,107 S. Ct. 577 (1986), (urine and breath test for licensed  ;

jockeys upheld); McDo_nnell v. Hunter, 809 F. 2d.1302 (8th Cir.1987),

(testing of prison guards); cf. RLEA v. Burnley, F. 2d , (9th Cir.,

decided February 11,1988).

39 Enclosure A

_---__---_.____-__-u--- -

n

\:

• il *.

'A random. testing program can be expected to have a stronger deterrence to

' chronic drug use than would a for-cause testing program. When drug tests are administered to all, employees on a random basis, a chronic drug user can expect, sooner or later, to be identified through the program. Some literature on chronic abusers indicate that they can effectively hide their drug or alcohol: problems from supervisors and fellow employees for a considerable length of. time. On the other hand, an occasional drug user could hope to escape being detected by a rencom drug test, especially if both the tests eno the employee's drug use are infrequent. In'either case, if' supervisors are highly proficient in observing probable impairment, the drug abusing employee may haVe little expectation that he or she could be impaired on duty and avoid a for-cause test. Knowing that fellow workers are disciplined for on-the-job

. impairment also can be expected to deter employees from being impaired on the job. Therefore, for-cause testing might be more effective in ceterring users

'from being im. aired on the job than woulo a random testing program alone.

There are two principal disadvantages of for-cause testing as a substitute for random testing. First, for-cause testing, as discusseo above, is likely to be a less effective deterrent against chronic drug use. Second, if managers are -

unable to identify impaired employees, for-cause tests will only.be administered after a gross indicator, such as an accident, shows that the tests are warranted; i.e., the test will be after the fact and not preventative.

Therefore, with the exception of post-accident testing, the value of for-cause testing is highly dependent on managers' and co-workers' abilities- to identify employees who are impaired and an organizational culture which allows managers to specify testing without disrupting employer /employe.e relationships or incurring adverse consequences. Thus, enhenced supervisor proficiency in.

behavioral observation through training and experience, and strong support from company management, is important in the administration of for-cause; testinc.

While for-cause crug testing is an important element of a fitness-for-duty program it does not appear to be an acceptable alternative to random testing.

40 Enclosure A

E. Bchavioral Observation Program.

Behavioral observation programs are intenced to enable supervisors to detect changes in an employee's behavior and to initiate the appropriate corrective action, usually a referral to the Employee Assistance Program (EAP) for initial evaluation and for-cause testing.

Supervisory referrals typically occur when a job performance problem beccmes dppd rellt. In these cases, the supervisor is responsible for identifying eno documenting the job performance decren:ent. In addition, he or she meets with the employee to describe the problem, to refer the employee to the EAP, and to indicate that continued irrpoired performance is likely to lead to disciplinary action or termination from employment. The supervisor is discourdoed from trying to diagnose the rcot cause of the problem er from trying to provide any counseling (Trice & Beyer, 1984; Hoffman & Roman, 1984). The EAP counselor takes the responsibility for these tasks and for referring the errployee to appropriate resources (the same procedure is followed when an employee self.-refers to the program). If the employee's job performance does not improve, then disciplinary action is taken.

The training that supervisors receive, usually from the EAP staff, in observing employee behavior rray allow them to detect problems that may be missed altogether by a drug screening program or that are obvious to everyone once the problem has reached severe proportions. Whereas a sophisticated and " street stdrt" drug abuser may be able to avoid detection from drug tests, he or she is unlikely to be able to maintdin satisfr.ctory levels of job performance on a day-to-day basis. As a witness te the employec's daily functioning, the supervisor represents a significant opportunity for identifying and removing from duty the employee whose job performance may adversely affect public health dad sdfety.

There are several disadvantages to relying on behavioral observation alone.

The primery disadvantage is the reliance on supervisors' behavioral assessment skills to identify persons unfit for duty and on their willingness to confront troubled employees. The reliance on supervisors' behavioral. assessment skills can be undermined by the fact that in the course of a reguler work day, 41 Enclosure A L

. supervisors have 'little, if any, opportunity to exercise the skills they have-

-received through training. If training is provided on an annual basis only, the skills can become rusty and heighten any reticence the supervisors may have initially experienced.in utilizing these skills. Also, while the. behaviors

' displayed by an individual intoxicated by alcohol are obvious and recognizable to most observers, the various effects of the wide spectrum of drugs currently.

abused may be less femiliar to supervisors, further diminishing any confidence inLrecognizing impairment, or allowing. impairment to cscape notice (Wrich, 1988).

Several barriers to supervisory referral have been identified ir, the literature. Theseinclude(1)thesupervisor'sdesiretohelptheimpaired employee, rather than expose.hir,n or her to potential disciplinary action, (2) a belief that the formal system [1.e., the Employee Assistance Program (EAF)]

should be used only as a last resort, and (3) the attempt un the supervitor's part to counsel the impaired employee (Hoffman & Poman, 1984). The possibility that an employee could-lose his or her job, nuclear safety responsibilities, or-unescorted access clearance if found to _be unfit for duty may make supervisors in the nuclear industry just as reluctant to refer the employee as supervisors in other industries in similar circumstances.

- A number of program components that can encourage supervisors to make referrals have been identified in the literature. In addition to a clear company policy and strong management support for the EAP, the importance of thorough and ongoing supervisory training has been consistently emphasized in studies designed to identify factors that increase EAP effectiveness (Gregoire,1979; Morgan-Janty,1982; Martin,Heckel,&Long,1984). Providing consultation services by the EAP counselor for supervisors ano continued program promotional efforts (e.g., po;ters and notices in company newsletters) have also been suggested as c means of encouraging supervisory' referrals (Hobson, 1981).

While an effective behavioral observation program is an important element of a fitness-for-duty program, it does not appear, alone, to be an acceptable alternative to random testing.

. 42 Enclosure A

. F. Medical reening.

A method currently used by one licensee is e medical evaluation for fitness of randomly selected employees to establish a basis for the collection and testing

' of urine.

The employee:is medically evaluated in three. areas: chemical use or dependency, physical well-being, and psychological well-being. Chemical use or dependency is established by using eye evaluation techniques covering such items as pupil size, pupil reaction to light, and the ability of the eyes to ccnverge on an object coming toward the nose or to track an object from_ side to side and around the face. In addition, the condition of a patient's skin, nose and mouth, coordination, and reflex response are evaluated. Some'of the evaluation is quite similar to fielo sobriety tests conducted by local law enforcement agencies. Physical well-being is reviewed through a complete evaluation of vital signs, including blood pressure, temperature, pulse, respiration, and heart rate. A medical history survey is also conducted to determine the current medical status of the employee. Psychological ~well-being is determined through a question-and-answer session evaluating mental

. awareness, depression, paranoia, self-esteem, anxiety and job stress, abnormal personality traits,. and major life changes.

There has not been sufficient data collected by the licensee using medical screening to establish any statistical significance to the results of this approach, and unfortunately, there is no "contrcl population" established that would provide scientific validity to the findings. Specifically, there has been a relatively low rate of testing and, of those few actually submitting urire specimens for testing, less than one half tested positive.

Since some impairing effects of some drugs (inost notably PCP) could be detennined long after the drug could be detectec in urine, this alternative does have one advantage over Pandem testing alone.

- It would seem that a strong behavioral observation program with highly trained and proficient supervisors would have advantages over infrequent medical screening because t'he supervisor would have opportunities to observe more 43 Enclosure A

_-w - - . . . . _ _ _ _ . - _ - - - - . , - - - _ _ - - , _ . - _ _ _ _ _ . - - - - - - - - - . - - - _ _ _ - . _ _ _ _ - - - - - - _ _ . - _ _ - - - _ _ _ - __ _ - - -

pi

, o

• f people'more frequently. It woul'd appear that .the udical screening alternative'-

L L would de less effective than random testing at cetecting and deterring oCCdsional use of drugs.

Medical, screening does not. appear to be a currently viable alternative to r.indom testing.

. G. Employee Assistance Programs.

Al preliminary review of the literature-pertainirg to Employ (.e Assistar.ce Programs (EAPs) indicates that EAPs can play a significant role in essuring. ,

that persons _ with unescorted access to nuclear power plants are fit to perform their duties. The major advantage of the EAP apprcach is that the EAP an respond; to a broad spectrum of fitness-for-duty problems, such as psychological; stress, that. cannot be addressed in a random drug testing program elene. There are severai disadvantages to this approach, however, that suggest that the hRC

-may not went to rely on EAPs alone to assure a workplace free of the effccts of dlCohol and. drugs..

EAPs have'been defined as " systems to provide professional care to employees whose job performance is or may be adversely affected by alccholism, drug dependence, emotional problems, family difficulties, legal issues, eating oisorders, and similar perscnal problems that not only threaten the employee's effectiveness on the job but also tend to trigger a whole range of heelth problems (Blair,1985). Thus, the EAP alternative is relevant to the entire range of fitness-for-duty problems.

The'EAP literature describes several program elements necessary to the successful resolution of employee personal problems (McGaffey,1978; Sornenstuh! & 0'Donnell,1980; ro ote & Erfurt,1981; Phillips 8 Older,1981; Roman, 1981; Bierman', 1982; Walsh, 1982; Gam, Sauser, Evans, & Lair, 1983; Wrich,1988). The " ideal" EAP has been described as incluCing:

Management support for the EAP in the form of a written policy statement describing the program and explicit written procedures

. 44 Enclosure A

--.__mm -

. . - . _ . _ . _ . - . _ _ . . . _ - _ _ . _ _. .__..__.m__.. _ _ . _ _____..____________m._._____..__.____._-. _ _ _ - _ _ _ _ _ _ .m_____m_-___

L ,

1 for implementing the program, Support for the EAP and cooperation f rom employee unions, Clearly. defined job performance standards, Well-trained supervisory stoff and knowledge of the EAP ameng employees, A recognition by management that performance problems can result from n.any different causes, Program staff who provide problem diagr.cses, appropriate referrals, treatment coordination, and follow-op, Comprehensive treatment resources, Health insurance coverage that is compatible with the EAP or company provided treatment funds.

A program evaluation process, An adequate budget.

Employees typically gain access to EAP services through two routes, self-referrals and supervisory referrals. When the employee self-refers, he or she may contact the EAP counselor directly or seek assist 4nce fro 9 a tuparvisor to make the contact. The EAP courselor ther, meets with the employee to assets the nature of the problea und to determine what resour:es are needed to resolve it. The counselor may prcylde the required assistance in some cases, but more frequently will refer the employee to existing res.ources in the community. The EAP counselor maintains contact with the employee curing the problem resolution phase and often acts as a coordinator between the employee and his or her supervisor while the empitjee receives inpatient treatment and when the employee returns to. work.

45 Enclosure A A A.-- . - - - - - - - . . - . . - - _ - - - - - - - - _ . - - - - - - - - , - - _ _ - - - - - - - - - - . - - - . _ , - - - - - - - - - - - . -.-_------___---------,---_------a-------._--- . - - - - , - - - - _ - , - - - - - - - - - - - - - - - , - - - - - - - - - - - - - - - - - - . - , - - - - - - . - - - - _ . . . - - - - - . _ - - - - - - - - . - - - - - - - - - - - - - -

o

' As' discusseo previously under the Behavioral Observation Program, supervisory referrals typically occur when a job performance problem becomes apparent. The EAP counselor is responsible for diagnosing the root cause of the problem or.d for referring the employee to appropriate resources (the same procedure is followed when an employee self-refers to the program). If the employee's job performance- does not improve, then disciplinary action is taken.

Although the literature suggests that~an EAP can serve as a valuable tool in assuring that employees in the nuclear industry are fit for outy, the primary benefit of an EAP lies in the potential it repmsents for assisting employees to overcome personal problems that are not alcohol or drug related but that may i_nterfere with job performance and frequently lead to alcohol end drug abuse.

For example, the psychological stress asscciated with marital or financial difficulties can impair performance of job responsibilities but will obviously not be detected with drug testing.

^

The EAP staff is typically responsible for conducting employee awareness training, and for training supervisors in behavioral observation techniques.

These are regarded by the NRC staff as important elements of an ef fective program.

The EAP literature typically discusses program effectiveness in terms of the benefits accrued from program implementation compared to the costs of the program. A number of studies have documented benefits along several dimensicns. These dimensions include reduced employee turnover (Gam, Sauser, Evans and Lair,1981), reduced training and employee replacement ccsts (Starr & 1 Byram,1985) reduced employee utilization of insurance b6nefits (Foote, Erfurt, Strauchy, & Gazzardo, 1978), reduced costs associated with incidental absence (Geeta. Lynn, a Grey, 1962), and reduced disability-payments (Shore, 1984). )

l Although the NP.C cannot be pririarily concerned with these cost savin 5s to the l industry, these data suggest that implementation of an EAP can have significant positive effects on employee availability and so may improve plant safety indirectly by contributor,9 to adequate staffing.

l 46 Enclosure A

m

'Of' greater relevance.to the NRC's concern with public safety are data pertaining.to reductions in on-the-job accidents. Rowlenc Austin of General

. Motors repcrts, "We have found that those who participate in the employce assistance program, as a group, reduce their on-the-job accidents upw6ros of 50 percent"-(1983). A study done by the Firestone Tire and Rubber Company found drug users almost four times as likely to be involved in plar.t accidents (cited in Journal of American Insurance, 1984-85); AT&T found that of 110 participants in EAP, 26 had been involved in accidents in the 2 years before participation ano only 5 were involved in ' accidents after part1cipation (Gaeta,1982). The

U.S. Postal Service also reports that the rate of on-the-job accidents has becn significantly reduced since implementation of their EAP (Eusiness Insurance, 1983). To the extent'that accidents in the nuclear industry ere related tc impaired employee performance, the existence ano use of an EAP hy troublec employees may directly improve the safety of plant operations. .

Data are not currently available that directly assess the effectiveness of EAPs in reducing. drug abuse with-ob,iective measures. Therefore, the relative effectiveness.of EAP's and random drug screening programs on direct measures cf drug use cannot be compared.

There are several disadvantages in relying on the EAP approach alone to assure that employees in the nuclear industry are fit for duty. The primary disadvantage of the EAP approach alone is its reliance on supervisors' behavioral observation skills to identify persons unfit for duty and en their willingness to confront troubled employees. (See related discussion on Behavioral Observation Prograr s.)

There are_ two additional disacuantages of the EAP approach used alor.e. First, the deterrent effect thought to result from random drug screening will be absent, altocugh fear of supervisory cctection in some cases may serve a similar deterrent function. Second, an EAP without random foilow-up drug testing lacks any objective mecns of ensuring that employees who have entered treatment for drug or alcohol abuse problems have been rehabilitated and can be considered reliable.

47 Enclosure A 4

s_--_.N___ -~ _---____-_-___--_--__--_-__-_.-__.__._-___--_-___--______-_n..-_.- - - - _ _ - _ - - - _ _ - - . _ _ _ . - - _ _ _ _ _ _ - - - _ - - _ _ _ - _ _ _ _ . _ ~

Khile there are drawbacks on the EAP approach alone, the merits suggest that

-EAP programs would perform a vital role in assuring fitncss for duty in tne nuclear inGustry. An EAP's ability to address potential eniployee istpoirment caused by problems that are not alcohol or drug related justifies careful consideration. It is also apparent that an EAP can play a significant function in detecting substance abuse problems that may otherwise ccntinue undetected

-thrcugh a drug testing progrun, as the EAP-trained supervisor can have frequent opportunity to identify on-the-job impairmert and a diminishing job performance.

H. Access Authorization Program.

The NRC is considering promulgation of dei access authorization prcgram to govern the granting of ur. escorted access to employees in nuclear power plants.

The proposed program, contained in a policy statement issued for public comment on March 9,1988 (53 FR 7534), woula require backgrcund investigations, psychological assessments (i.e., testing and interviews), and an cngoing behavioral ob'earvation program for employees with unesecrted access. The behavioral observation program that would be implemented, should the proposed policy statement become effective, is the same behavicral observation progrcm that would be implemented in accordance with this proposed fitness-for-duty rule. The requirement in this proposed rule for licensees to conduct a suit-able inquiry to determine if a person has a history of fitness-for-duty problems is compatible with the background investigation that would be conducted under the access authorization program.

The program under consideration would expect .he licensee to determine whether the individual considered is not only reliable (i.e., fit for duty) but also can be trusted with access to nuclear facilities. There are a number of ddVantages as Well as disadvantages to this approach when compared to implementing a random drug testing program.

The unique benefit provitea by the access authorization program is that the, background investigations and psychological assessments are intended to detect an individual with a history of, or potential for, drug or alcohol abuse or 48 Enclosure A 1

1 other problems that might make him or her unfit for duty before the person is granted unescorted access.

The background investigations and psychological assessments, of course, do not deter drug abuse and would not detect individuals who develop substance abuse problems after they have been granted access. The behavioral observation component of the proposed program is designed to improve the probability that unreliable and untrustworthy persons are detected.

Background investigations, psychological ..ssessncnts, and behavioral observation programs, although sometimes controversial in terms of effectiveness, are well accepted for sensitive positions in various industries and types of government service. lhe disadvantages of sole reliara en the access authorization opproach, however, include a reic.tively week deterrence to drug abuse in comparison to that provided by random drug testing, and a lack of dny reemployment drug testing Cr ongoing Objective assessment of drug use.

I. Workplace Security Measures.

This approach to assuring that employees with unescorted access cre fit for duty includes such techniques os searches of the workplace. The advantage of this approach over random drug testing is that employees are likely to be deterred from possessing or selling illegal drugs onsite to a greater degree than with randem drug testing, because these security measures directly detect possession while random drug testing only assesses recent use. The disadvantages are that it cannot establish use of drugs, ar1 it cannot address other types of fitness for duty concerns. Therefort, workplace security measures, although important elen2ents to an ;ffective program, should not be considered an adequate substitute for random drug testing.

49 Enclosure A

O i

J.- Employee Awareness anc Education Programs, i

Any' fitness,for-duty progrem based solely on employee awareness and eoucation about the deleterious effects of drug abuse is likely to be ineffective.

Behavior .isl notoriously resistant- to change on the basis of knowledge ~ alone.

Consequently, this approach is not likely to provide a powerful deterrent to

' drug abuse. . As an adjunct to other fitness-for-duty approaches, however.

employce.' awareness:and education can contribute,to a drug-free ~workplace.

An employee awcreness and education prc9 ram is a necessary. compcnent of druf testing'and employee assistance programs (EAPs). Employees must be informed' abcutithe rationale for drug testing and about proceoures for making referrals to the EAP. Enployee awareness and education also provide f urther evidence of the seriousness with which managucent views fitness-for-duty issues.

In addition to these b,enefits, an employee awareness and education program can be developec.to make use of the troubled employee's co-workers to detect potentia 1 ' fitness-for-duty problems. With training in behuvioral observation, co-workers may be able to spot unusual behavior even before the employee's supervisor notices it. In addition, co-workers may hear of drug use, alcohol abuse, or other employee problem's that would not be detected by the supervisor until the problem had become so severe that public health and safety had been jeopardized. Although co-workers may be reluctant to report unusual behavior or potentially damaging information in a public manner, the availability of a confidential hotline can encourage them to report and provide management with an opportunity to investigate the problem. Knowing that his or her co-workers are trained to identify aberrant behavior also may serve to deter an employee from substance abuse.

IV. Rate of Random Tests.

The purpose of random (unannounced) testing is to provide reasonable assurance that employees are fit for duty by identifying current orug users and by deterring drug users from further use or potential users from initial use. The frequency with which an individual is tested is relevant to both the identification and deterrence goals of the drug testing program. Generally, 50 Enclosure A

the more frequent the testing, the greater the deterrent'effect dnd the better the detection capabilities. However, very frequent testing may result in unacceptable economic cr social costs. Although there'is no research upon Lwhich the testing frequency may be-based, it seems reasonable to assume that:-

Any form of unannounced testing would provide some level of deterrence,

' There would be little deterrent if the testing dates were predictable and the druc user knew he was not immediately susceptible to ar.other test.-

Testing each day would provide more of a deterrent- thdn testinc once each week or month, especially if there was high visibility resulting from the daily activity.

Deterrence is related to$.either the actual or perceived probability of deteccion.

The actual probability of detection is related to the type of drug, dose, frequency of use, rate of icetabolism and excretion from the body, dnd the frequency of testing.

The perceived probability of detection is related to the frequency of testing, the " publicity" given positive findings and sanctions imposed, and the abuser's knowledge of the rate of metabolism ar.c actual probability of detection.

For example, the probability of detecting the use of marijuana, since it is metabolized slowly, is much greater than for alcohol, which is excreted in a matter of hours. Chronic users of marijuana would probably have the greatest probability of detection.

An individual ingesting a " typical" cose 2/ of marijuana (e.g., one cigarette) once each month would have a probability of detection of about six percent if 2/ Since there are no quality controls in the drug culture, the quantity and purity of doses vary considerably.

51 Enclosure A e

_____._____m- _ . . _ . _ _ _ . _ _ _ _ _ _ _ _ _

_ , _ _ -_ - - _ - = _ _ _ - -_

.the;workforce were randomly tested using a cutoff level of 100 ng/ml et a rcte: l equal to 100 percent during the year. By selecting persons for testing oaily H !at that rate, approximately 63 percent of the work'iorce actually.would be'

-tested.- Lowering that cutoff level to 20 ng/ml would increase the probability of detection to about 22 percent. More chronic or heavier use (i.e., once each week or 2 or 3. cigarettes each month) would raise the probability of detection

,to near 63 percent.. If the workforce were randomly tested using a cutoff level 1 'of!100 ng/ml at a rate equal . to 75 percent curing the year, the probabilities of.'detecticn would be-about 2~ percent-for monthly use and 50 percent for-chronic use. If the rate of random testing were equal to 125 percent of the h workforce, the probabilities of detection would be about 9 percent and 71 I percent-respectively.

.s y

An individual ingestir}g a' " typical" dose of cocaine, i.e. 50-100 mg, once each week would have a probability of detection of about 13-15 percent if the  !

.s workforce were randomly tested at a rate equal to 100 percent during the year.

.}

If the workforce were randomly tested during the year at a rate ecual to 75

]

percent, the probability of detection for weekly use of cocaine would be about 7 percent. If the workforce were randomly tested at a rate equal. to 125 V}

percent, the probability of detection would be about 18-23 percent. '

With less frequent testing (e.g., 10 to 20 percent of workforce each year) the probability of detection for an individual becomes unacceptably small even fc~r relatively frequent use. It should be noted that those utilities currently using random testing report between one and two percent positives associated with various rates of testing of the workforce. The DDT proposed anti-drug program proposes that each employer annually test, rancomly,125 percent of all cirline. employees involved in flight operations and maintenance (53 FR 6368).

At the upper end of the scale, the individual U.S. Navy commenos typically test rondomly at a rate of 20 to 25 percent each month (approximately 300 percent peryear). The evidence from the military experience shows that there is i.n increasing deterrent effect from increasing the frequency of testing (Stoloff, i 1985). Increasing the rate to as high as 700 percent of the workforce b

continues to show increasing deterrence. However, most of the deterrent effect ,

52 Enclosure A i

- _____._________________.___._____._______________.___.___-____._____.________.___m._..________._ _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

.is realized below 300 percent. The nuclear workforce may have different characteristics than the military workforce. The same factcrs that bear on-favorable rehabilitate',on outcomes, discussed in Section VII. C., may also lead to deterrence at lower testing rates.

In addition to the need tr conduct random tests at a rate that will prcvide i both suitable deterrence t id detection, the Commissicn desires to use a sampling strategy that assures that a high percentage et the population is tested once per year, ano that a low percentage of individuals is tested n.cre than once each year.

The selection of a sampling strategy is guided by several objectives. The two primary objectives, deterrence und detection, have been discussed above. An effective testing strategy must assure that all workers subject to the rule are

~

continuously subject to testing at a rate suitable for deterrence. The strategy should not be overly burdensome to either the licensee or the empicyee. The strategy should be cost effective and easy to administer. U3 Specific individuals should not be tested overly frequently (unless they have had a confirmed positive test). Tl.e strategy should be nondiscriminatory; it should be administered fairly across all individuals and categories of individuals to minimize negative effects on employee morale. While it can be demonstrated that different categories of workers raay be more inclined to drug abuse (e.g., males versus females, younger versus older, centractor personnel versus utility employees), considerations of perceived fairness suggest that all categories of workers be tested at the same rate.

In selecting from amung the various strategies, however, some comprumise among the various objectives will be necessary. For example, decreasing the testing rate relieves some of the burcen on the licensee and the individual worker.

However, decreasing the rate too far jeopardizes the deterrent and detection objectives of the program.

A strategy that combines a high testing rate for workers not yet tested in a given calendar period, with a relaxed testing rate for already tested workers 53 Enclosure A l 4

-(those'with negative tes+ results), provides for a reasonable balance among the program objectives. Severai alternative models were conside. red.

A traiel that tested at a flat rate of 100,_125, 150, 200 and 300 percent of the population'for the year-(see Table 1).

" ' A model that-tested at the rate of- (e.g.).100 percent per year of the population for the first period and continued at this1 rate.of. testing for subsequent pericos' for those not yet tested. However, the rate of testing of the already = tested population was reduced to a lower rate during C 3 sequent periods of the testing'yes: . Variations of tha m'Jel were considered using:

Monthly, quarterly, and semi-annual periods for aojusting the tested population.

Testing rates for the untested population of 100, 125, and 200 .g.J -

percent per year of the-tott1 population.-

Testing rates for the actual tested population of 10 and 30 percent per year.

(See Table 2 for these variations.)

An evaluation of the alternatives indicated that strategies can be develcped.

that achieve an acceptable balance among the program objectives. For example,

-Case 9 in Table 2 would have the following characteristics and advantages:

Test at a rate equal to 100 percent / year for the first month. (For a population of 1,000,.about 83 tests) i For the part of the population that remairs untested at the end of a month, test at a rate equal to 100 percent / year of the entire population. (That is, continue at 83 tests per month on the successively reduced untestec population.)

For the part of the population that has been tested prior to the start of a given month, test at a rate equal to 30 percent per year (2 1/2 percent per month) of the already tested population. (For a total population of 1,000, this would mean 2 additional tests in the secono nA e

month increasing to about 20 additional tests in the 12th month for the a ( &o

\

previously tested population.) A testing rate of 30 percent per year for i t

i

. 54 Enclosure A

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s 0 ig e l gd a t t e 1 5QM i ne s s t s f s bit t a a r e aec a e ee l 0 e eh bb e l e l c a0k  : hT o l t c r y o 0, o i t T rf e o t n t w e

• P os M A o At T 1 w K * *

$t l

.c, individuals already tested at a rate'of 100 percent or more would provide a modest level of detection and deterrence while relieving some of the

~

j burden from-the individuals who have been tested and found free of drugs f '

[

at the' time' of the test. Howevnr, it should be noted that the'oeterrent effect potentially will be reduced for thel tested population. A. testing rate of 10 percent per year was judged so low that a ' deterrent effect was  !

questionable.

'This strategy results in only a few more totai tests than testing at a tiat,

.100 percent ' rate, and substantially increases the percent'of the workforce sempled during the year'(from about 63 percent 'to about 91 percent). Further, the ' amount of retesting done on particular individuals is not excessive, given the need to retain sorre deterrent effect, even for the already tested population.

1. 3 While Case 9 of Table 2 achieved an acceptable balance among the program objectives, it may not be.the only method which does so. To ullow a reasonable amount of flexibility in program implementation, the Commission proposes to state performance based objectives rather than a specific methodology in the rule. The rule as proposed would require random tests to be administered in a way that at leest 90 percent of 'the individuals within the scope of +% rule are tested each year, that testing is performed throughout the year and that

. testing rates for individuals already tested with negative results not be lower than 30 percent per year (21/2 percent per month) for the remainder of the -

testing year.

Other approaches were also considered including:

• ' Occasional, unannounced, mass testing Testing as a part of the annual medical exam Testing " windows" of a few months auration associated with an annual event, such as a birthday However, these approaches were considered to provide too little assurance that  !

testir.g would be truly random, and individuals would not be subject to testing through the calendar period.

. 55 Enclosure A e

4 i p.i' Cutoff; levels.

1 4The' selection o'f cutoff Llevels for declaring the result of a drug test to be.

'" positive" and to take sone personnel action is as much' an issue of policy as science.. - Whereas the technologies of the test may permit very low cutof f levels under ideal- situations, a cutoff level-set slightly higher than the lowest that is. technically feasible provides generally adequate sensitivity to

' ioentifyc abusers while providing a sufficient buffer to withstand challenges.

Prior to implementing a program to test urine for drugs of abuse, it is -

important to understano what information urine tests provide and how the

- results can be interpreted. Simply stated, urine test results provice information ebout the concentration of particular substances in the urir.e. The

- concentration of a drug or drug metabolite in the urine does not provide much information about pharmacologically active drugs in a person's system, nor does it provide information about . impairment (Hawks,1982). The concentration cf a drug or drug metabolite in the urine-is influenced by several factcrs; these include the dose of the drug taken, the route of administration, frequency of use, and the time lapse from crug use to urine collection (Manno, 1986, Hawks & .

Chiang,1986). The concentration is also influenced by several factors

- unrelatea toidrug use such as amount of. liquid recently consumed, time since previous void, time of day (urine is more concentrated in the morning than later in the doy), and recent dehydrating exercise. Hence, a positive confirmed test result-indicates only that an inoividual has recently ingested the drug. A positive result does not provide information about frequency of use, pattern of use, addiction, legitimacy of use, or whether the person was under the influence of the drug when the urine sample was collected (Manno, 1986). Similarly, a negative test result only means that a person's urine sample did not have the drug or crug metabolite in sufficient concentration to give positive results (Manno, 1986). It does not necessarily provide information about whether or not the individual hos ever used the drug cr whether someone currently uses the drug infrequently (Hawks,1986).

Because of the numerous factors that influence the concentration of a drug or I

drug metabolite in the urine and the levels of impairment in any individual E (see previous discussion under section I, impairment and reliability), it is

. 56 Enclosure A m_.____ ._______,_..._:.

e not possible within the current state of the art to set cutoff levels that relate to a precise measurement of performance impairment. Research has been initiated and sometime in the future it may be possible to aaaress determination of impairment based on serum analyses.

In determining the cutoff levels specified in the proposed rule, the NRC considered what levels et the drug would probobly be found several days af ter use and the sensitivities of the various analytical methods available. For example, the longest time reported (c.ctudl times are shorter) that a " heavy" user of marijuana wouir! fieplay detectoble quantities at a cutoff level of 100 ng/ml would be 2 weeks shouia the cutoff level be lowered to 20 ng/ml, the

" detection time" would be increesed to 4 weeks, significantly incre6 sing the probability of detection and deterrence. For an occasional uset of morijeera, the longest detection time at a cutoff level of 100 ng/ml would te 3 days; lowering the cutoff level to 20 ng/ml would extend the detection tirre to 10 day;. For cocaine, o typical dose of 50-100 mg would be detectable for 37-45 hours at d cutoff level of 300 ng/ml. Heavy or occasional use would not result in significant differences in detection periods.

The NPC also considered the cutoff levels established by the Departments of Hedith and Human Services (HHS), Defense (C0D), and Transportaticr (POT). The NRC has concluded that the cutoff levels described in the " Mandatory Guidelines for Federal Workplace Drug Testing Programs" issued by HHS cn April 11, 1988 (53 FR 11970) should be adopted. Some authorities believe that lower cutoff levels for initial screening tests of marijuar,a are appropriate, as discussed below. The Commission has decided not to take exception to the cutoff level for initial screening tests of marijuana for the sake of consistency with the federal guidelines. The Comission invites curment on this raatter.

The Commission understands that all of the test levels set by HHS are subject to change as worrdnted by ddvances in technology or other concitions. ' Any chances to the HHS Guidelines subsequent to final NRC rulemaking of fitness-for-outy programs will be ccnsidered and appropriate rulemaking taken to amend the NRC rules. It should be clearly understood that the Commission regards the HHS Guidelines as minimum standards. Licensees, at their discretion, may implement 4g prcgrams with more stringent standards (e.g., lower cutoff levels).

57 Enclosure A 1

l L_ __-- -- - - _ _ - - - - - -- _ - - - - - - - - - - - - _ _ - -

l L

• Considerations relating to the. cutoff levels for each drug are discussed below.

l l,

l. 1.. Marijuana metabo'ites.

An issue frequently raised when testing for marijuana metabolites is that a true positive test may result from passive inhalation. The cutoff level of 100 ng/ml for initici sc'reening tests was set by HHS to ensure that tests would not result in positives due to passive inhalation. It should be noted that there l is some disagreement on the level at which passive inhalation is a problem.

While some authorities believe that a cutoff level of 2C ng/ml may te a problem, others believe that a cutoff level of 5 ng/ml would not encounter significant passive inhalation problems. Recent studies indicate that only under the most extrcme conditions (prolonced exposure to high ccccentratiotr ut marijuana smoke) would passive inhalation lead to a positive result at 20 ng/ml (Cone, E. J., et al., 1987).

Assay reliability at 20 ng/ml has been raised as another potentiel problem.

The e6rly Enzyme.Multiplieo Immunoassay Technique (EMIT) tests were capable of detecting 50 ng/ml of marijuana metabolites in urine with 95 percent confidence (Peat, Finkle, and Deyman,1982). Improvements have been made in the EMIT test, however, and a number of clinical studies indiccte that false positives are no longer a problem at the 20 ng/ml level (McBurney, Bobbie, una Sepp.

1986). In fact, some studies show an unnecessarily high level of false negatives when higher cutoff levels are used (Kogan, Razi, Pierson, aro Wilson, 1986).

2. Cocaine metabolites.

The initial and confirmatory cutoff levels as set forth by HHS (300 ng/ml initial; 150 ng/ml confirmatory) are sufficiently low due to detect reguler -

users who would test at a much higher level, e.g.,10,000 ng/ml at peak concentration for a normal user of cocaine. The EMIT tests currently useo by most licensees will result in a positive for 18-27 hours after use (Verebey, 1987).

. 58 Enclosure A

f

[

7

, 13. Opia'tes.: .

~

-lThe fundamental problem with opiate testing is dietary' consumption of legal

! substances'(e.g., poppy seeds) and the use of over-the-counter drugs that yield true positives. Testing someone who took some cough syrup or. ute's poppy seed roll . prior to'the, test could yield 'a true positive that wasinot due tc. drug

.use. For instance, a person who consumed a' normal dosage of cough syrup prior .

to.the. test could' have ccccentrations of 10,000 ng/ml in their urine. ' A person -

who ate a moderate amount-of poppy seeds could have opiate concentraticos of 1,700 ng/ml.

The cutoff level for initial screening tests for total opiate tretabolites was set by HHS at 300 ng/ml; with free morphine set at 25 rig /ml. Regular users would have much higher concentraticos. ..For. example, a person who has been given morphine as medication would have an approximate level of 4,000 rg/ml; for codeine mea 1 cation the level woulo be 2,000 ng/ml.

The NRC concluded that lower cutoff levels greetly increase the rish of true positives due to-dietary consumption of an opiate, not necessarily conrected with illicit drug use. Chronic arug users of opiates woulc be likely to have tru'ch higher concentrations in their systems, e.g., for codeine the level would be 30,000'ng/ml. To provide further protectiot, against true positives oue to dietary consumption of an. opiate, the Commission is proposing that a Medical-Review Officer review and interpret positive confirmatory test results as provided in the HHS Guidelines.

4. Phencyclidine (PCP).

A typical user would have coricentrations of 500-600 ng/ml. As with cocaine, the.HHS specified cutoff Ievel of 25 ng/ml is sufficiently low to permit detection for a few days. Mdny licensees are currently ccnducting initial screening tests onsite using the EMIT test with a cutoff level of 75 ng/ml for PCP.

. 59 -Enclosure A

_ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _____-__-_______.___________________m_____.________________.__._____-_____._m- _ _ _ _

y ,

SL Amphetamines.

The! fundamental problem withl cutoff level determinations for amphetamines is

thefpotential for cross-reactivity and true positives due to over-the-counter-drugs. --In light of this,- HHS has set the cutoff levelsj at"500 ng/ml for confirmatory tests. -Assay techniques are sensitive well below this-level..

A~

regular user of amphetamines would have urinary concentrations of 5,000-20,000 ng/ml..

~6. Alcohol.

' Alcohol is.a drug whose effects are well known and cocumented, yet different jurisdictions.have-set different levels between 0.05 and 0.10 percent alcchui in the= blood at which ene'is considered legally impaired. Studies have shown

~

' that irrpcirment depends on many factors unique to each individual, that impairment can exist at-0.04 or 0.05 percent alcohol in the blood, and that on

? upper limit: of 0.05 percent'is easonable given the impairing effects of

. alcohol.

'The effects of alcohol may be felt prior to reaching peak bloco alcohol concentration (BAC) levels in the bocy. In one study, researchers found that

'the' time toi peak BAC was an average of'24 minutes later than the time to peak alcohol'effect (Radlow and Hurst, 1985).

L

[;

L Performance decrements due to alcohol consumption can occur at re16tively low-lBAC levels. One study which measured skills performance (divided attention and information processing) at low BAC levels showed evidence of impairment If beginning.at 0.015. percent BAC and increased impairment with increasing PAC levels'(Moskowitz,etal.,1985). One interesting. note on'this stucy is that the subjects were 10 males averaging 25 years of age, all moderate drinkers.

-According to epidemiological studies this group is relatively resistant to the effects of alcohol; thus it is anticipated that greater degrees of impairment I

at BAC levels between 0.015 and 0.06 percent would typically exist for younger, older,.and less frequent drinkers (Moskowitz, et al., 1985).

O .

l A review of literature on physiological studies of low BAC levels show that the l

L

.. '60 -

Enclosure A L. -

m

+

' amplitude ano velocity of smooth pursuit eye movements ano saccadic eye-movements are reduced by alcohol. These changes are physiologically significant at'a BAC level of 0.05 percent (Linnoila, et al'., 1986). Saooth eye pursuit and saccadic eye movements have been shown to play a significant role

! in visual information processing (Flom, et al.,1976).

In a recent-rev1ew of the literature for the aviation industry it was concluded that significant impairment is ger:erally noted at the 0.04 to 0.05 percent g levels and' that experience did not compensate for perfonour.ce degradation resulting from alcchol use. The review also includeo studies of simulateo aviation flight, which showed that decren: ental effects on performance occurred fn terms of aircraft position errors and procecural errors during the approach

. phase of landing, instrument flight involving standard traneuvers, er c other work loaa neasures at all BAC levels between 0.02 and 0.09 percent BAC (Ross andRoss,1985). Another study (Clayton,1980) reported significant impairment of ariving skills at the 0.04 to 0.05 percent levels, while a more recent stucy (Moscowitz,1985) reports significant impairment of perception at even lower levels of blood alcohol.

The FAA prohibits any person from acting as a crewmember of an aircraf t while having 0.04 percent.by weight or more alcohol in the blood (14 CFR 91.11). In addition, the Council on Scientific Affairs of the Americcn Medical Association, has endorsed the 0.05 percent cutoff limit for driving (COSA,1986). In one recent analysis of the deterrent effects of reducing the legal limits for blood alcohol from 0.08 to 0.05 percent, a 14 percent reduction in fatalities associated with drinking ano driving was noted.

Several statements mdy be made regarding a BAC level of 0.05 percent and consequent impairment:

BAC levels in general' are highly correlated with accid (nt risk and are a major causal factor of serious accidents (O'Hanlon, et al., 1986).

There is growing consensus that a BAC level of 0.05 percent impairs cognitive anc task performance in a variety of measurable forms such as skills performance and physiologic indices.

61 Enclosure A

Performance. decrements at low BAC levels:'(0.015-0.06 percent)in'a

.cose-related manner have been demonstrated-(cf. Moskowitz, et al..:1985).

BAC levels above 0.04 percent' are associated with an accelerated risk of.

causingaccidents-(0'Hanlon,et'al.,1986). However, it may be reasonably-assumed that even lower'BAC levels (0.01-0.05 percent) potentiall'y l ~

increase the risk of accident. Some researchers have recemn. ended that a i zero BAC level be established for tasks requiring complex cognitive and-physical. performance.

l l- Accident rates among persons with a BAC level of 0.05 percent are significant-as measured.by automobile accidents, aviaticn accidents, industry surveys, as well as general population studies, experimental-research, and clinical studies.

l l

Impairment of cognitive ano task performance at the BAC level of 0.05 percent and higher has significant implications for power plant safety, l

. and is thus a legitimate concern for fitness-for-uuty policy development.

l While the' potential adverse effects of alcohol cannot be discounted, based upon l industry commitments made to the Conaission, the NRC believes that programs already established to meet-the Commission's Policy Statement (51 FR 27921) and .

the Edison Electric Institute's "EEI Guide to Effective Drug and Alcohol / Fitness-for-duty Policy Development," adequetely address' this matter without prescriptive NRC regulation. These programs include the following attributes for coping with alcohol:

1  ;

All-licensees have policies which prohibit alcohol on company property i and, at a minimum, state that use of alcohol that adversely affects job performance is not acceptable. Violation, of the company's policy may result in disciplinary action up to ano including termination. 48N All licensees have Employee Assistance Programs that include treatment l of alcohol abuse.

l 1

62 Enclosure A

s ,

p, All supervisors, and other key employees, are trained in behavioral j observation tcchniques, which incluce aetection of symptoms of alcohol abuse. pgg Testing' for alcohol is included in for-cause tests. Cutoff levels are unusually consistent with state law regarding driving while intoxicated, liowever, the Commission invites coment on whether the flRC should specify a Cutoff level for alcohol.

Licensees have identified and taken action on a number of  !

fitness-for-duty probltms caused by abuse of alcohol. NE@/]

7. Issues regarding test reliability at very low cutuff levels.

Although current assay techniques can accurately test for substance presence at much lower levels than set by the HHS Guidelines, there are issues concerning test reliability at very low . cutoff levels. A well publicizeo issue is that the presence of target substances oue to the ingestion of legal substances, or in the case of marijuana, passive inhalotion, can be detected through low cutoff levels. These alternate sources for true positive results are in.portant to consider in setting legally defensible cutoff levels.

In addition, there are fundamental questions concerning quality controls of applied testing on a massive scale; c.g., test reliability, carryover from one assay to another, and sample handling and storage. For example, the gas chromatography coupled with mass spectrometry (GC/MS) method essentially produces a fingerprint of the drug or metabolite. However, the assay requires an " internal standard"--a deuterated sample 3/ of the drug or metabolite. Some percentage of this added internal stanoord (approximately 7 percent) will not have been deuterateo and will thus show up as a drug or metabolite. This can

~

3/ A sample that is deuterated is 6 pure drug altered in order to increase its molecular weight without changing how the substance behoves under extraction, derivation, or chromatography procedures. The technique involves replacing a few hydrogen atoms on the drug molecule with deuterium atcms.

- 63 Enclosure A

- _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ . ._ . _ _ . _ _ _ _ _J

e 4

be subtracted out of the reading but at low cutof f levels this adjustment may exceed reasonable / normal deviations for the test itself. Thus, the purity of the internal standard poses problems for using very low cutoff levels. Also, there is variation in the extraction procedures, and only 75-80 percent of the drug or metabolite may be extracted. The internal standard can be used to adjust for this variation but within limits.

Fiu.11y, technical and legal implications of these issues could pose a problem.

For example THC (marijuana) deteriorates in samples even when stored properly.

The process of establishing low cutoff levels must address the problem of sample deterioration and reconfirmation at a later date. In general, the lower the cutoff level, the more difficult it will be to reconfirm. Although assay technology is suf ficiently precise in c controlled and reguleteo setting, the fundamental issue is whether the technology ccn be performed at 100 percent of its capability at all times. A general rule of thumb used by the D00 for determining legally defensible and practical cutoff levels is to double the detection limit of the specific assay technique. That is, the D0D requires that an assay be able to detect concentrations of drug or metabolite in the urine at 50 percent of the. set cutoff level. While not "scientiilc" in its basis, it is probably practical in its anticipation of problems in the legal process.

VI. Number of positive tests.

A significant policy issue associated with fitness-for-duty programs involves the question of how many confirmed positive tests sMuld be allowed on any one individual before mandating action, such as removal from a safety sensitive job.

One approach is to establish a "zero tolerance" for drugs; any involvement with drugs results in mandatory remove.1 from nuclear safety duties. With this approdch, all violations of policy have equal severity; onsite use would have the same consequences as offsite use. Furthermore, any previous offsite use admitted during Employee Assistance Program (EAP) counseling would also result 64 Enclosure A

.m e.;

in mandatory removal, which would. have a- severe adverse impact on-the effectiveness ot-the EAP.

Another approach islto permit licensees to determine on d' case-by-case. basis what _ sanctions, if_ any, will be imposed'. Inconsistencies in the actions taken would probably result at the. site:. level or between licensees, and leave fitness-for-duty programs vulnerable to challenges through legal proceedings.

The'NRC believes public health and safety cam be well-served it employees are encouraged to voluntarily seek help before their problem is manifested in observable abnormal behavior.

The approach proposed by:.the hPC is a "zero tolerance" for any involvement with illegal. drugs within protected. areas; i.e., any use, possession or sale of illegal drugs within a protected area would result in removal from activities within the scope'of the rule for a minirrum of five years. Any offsite use of crugs would result in mancatory removal from activities within the scope of the proposed rule until such time as a determination is made that the person is fit

' for duty. A second positive test would rasult in the removal from activities within the scope of the proposed rule for a minimum of three years. To ensure that personnel actions are based.upcn accurate information and to provide safeguards for employees, the NRC proposes final review of test results by a Medical Review Officer as described in the " Mandatory Guidelines for Federal Workplace Drug Testing Programs" issued by HHS (April 11, 1988; 53 FR 11970).

VII. Reinstitution of' unescorted access.

The NRC has a strong interest in assuritig that among nuclear power plant personnel who test positive, or are otherwise determineo to be involved with impairing substances only those who have succeeded in treatment are allowec to- NY i regain their unescorted access authorization. Consequently, the Corm:ission believes that it is appropriate to require some time period to elapse to assure, before the individual-is returned to unescorted access following the first confirmed positive test result, that licensees have obtained a high l

65 Enclosure A

[,

p .

l Jconfidence that the problem has been, resolved and that the individual does not

_ constitute a: threat to safety.-

.One approach to this issue is to establish a relatively lengthy period, auch as ll 90 days or longer,;during which the individual is not permitted unescorted l access while he or she successfully completes treatment. Another approach is ,.

to establish .a shorter period of sufficient duration (e.g., two weeks) to h permit the individual to be referred to the EAP for assessment and development l of'a treatment' plan-. With this opproach, return of the person's unescorted access authorization c'epends.upon the-judgirent that the inci<idual will not pose a threat to plant safety by a nedical professional cualified in' the analysis and treatment of substance abuse disorders.

Drug abuse " careers" vary to:o great extent between individuals; furthermore; research indicates that a relapse to substance abuse can occur at any time '

after an apparently successful treatment episode. Therefore, treatment .# 7 programs need to be tailored to the individual. To ensure that utilities Carefully ' assess the nature of the individual's substance abuse probleir and.

develop plans for appropriate treatment and future employment, the proposed rule would require removal for a minimum of 14 days. A discussion of these issues in greater detail follows.

T A. Substance Abuse Careers The treatment and recovery literature indicates that an individual's pattern of j substance abuse can best be viewed as a cycle that includes both recovery and

^

relapse (Senay, 1984; Tims and Leukefeld, 1986; Maddux ana Desmond, 1986). The cycle, which has been described as the " substance abuse career" by Maddux and Desmond (1986), ranges from no use to recreational / social use, to problem use, to dependence with the inability to obstaln. Patterns within this cycle vary not cnly from individual to incividual, but over tirae in a given person.

Substance abuse careers diff er in terms of the type and number of substar.ces used, whether they are used sequentially or concurrent'y, and in terms of the intensity of use, whether episodic or continuous. Little is understood about the sources of these differences. Research has not yet provided a valid set of 66 Enclosure A

_' jv $

predictors th'at' would allow individuals' to be screened for susceptibility to-Lsubstcnce abuse.

10' Those individuals who meet the diagnostic' crit'eria for dependence will. most-

.likely. experience successive cycles of abstinence, occasional'use, daily use, and treatment. '"Depenaence" refers to bothit he altered physiological state resulting- from continued use of a substance, and 'to.the behavicr indicated.by I

regular compulsive 'use (Maddux ano Desmond,1986). .  :

Substance abuse appears to not fit the usual nedical treatment model 'of a .

disease that is responsive to a singula'r treatment episode ~(Senay,1984).

Rather,.the recovery research ir.dicates that there is nc one point in' time that

.ansindividual can be considered " cured." However, attempts have been nade to icentify a point in time.since treatment at which an individual can be .[

considered fully recovered. For example, the American Medical Association has  !

-develcped criteria for recovery that include three years of abstinence from the-primary drug of abuse and no abuse of other substances. Other investigsters have recommenced five years of abstinence as a reasonable benchmark. As will ,

be discussed below however, longitudinal studies have failed to isolate a

threshold for length of abstinence that determines permanent recovery. ]

Consequently, recovery is most accurately described as a process rattier than as a state. Recovery can be defined as the process by which substence abuse and related behaviors become decreasingly problematic for the affected individual. i Alcoholics Anonymous developeo their 12-step recovery model on this premise; members refer to themselves as " recovering alcoholics," recognizing that they are always at risk for relapse (Senay, 1984; Madoux and Desmond, 1986: Wesson, Havassy'and Smith, 1966). Because recovery represunts a process rather than a.

state, and because an individual's progress through that process cannot be predicted by elapsed time since last tre6tment, revocation of an employce's unescorted access for an arbitrary period of time.following a contirmed pcsitive test result alene would not ensure that the individual would remain

' drug free.

.. 67 Enclosure A

.4 ,

B. Relapse: rates. [

" Relapse" has been defined as'the " return to. substance use, following a period

-.of voluntary or-enforced ebstinence, at a level of intensity. comparable to that ,

attained before abstinence" (Bobor, Cooney, Lauerman,'1986, pg.=20).- Relapse j to the.use. of alcohol and "ioids has been extensively studied. Far less I information is available on'cne substance- abuse careers of those who primarily abuse marijuana, cocaine, phencyclidir.e, or other categories of drugs (Jaffe,

~

1984), because abuse of those substances is a relatively new phenomenon.

It-is~ noteworthy, however, that the alcchol ano drug treatment community has recognized for several years. that a combined approach to drug and alcchol treatmerits is most-effective, as the recovery process is tinilar acrcss the various substance categories (Cole, tit al.,1981; Waldorf ana Biernacki,1981; McClellan,1984). Current research supports this belief: The behaviors assv.iated with dependence and relapse to alCohcl and opiates are.highl>

similer (Pounsaville, 1986). dY

-Many studies are available that address the occurrence of alcohol relapse on both a short-term and long-term basis. The short-ter'm studies, defined by tracking of post-treatment individuals for a period of two years or.less, indicate that relapse rates for alcohol are quite high. For example, one study that' followed 685 post-treatment individuals found that 63 percent were abusing alcchol when contacted at the two year mark. A second two-year study found a 67 percent relapse rate (Vaillant, 1983).

The relapse rates for opiates are dramatically similar to those of alcohol.

One study found 67 percent of opiate dependent individuals to be readdicted within the first six months following treatment (Maddux and Desmond, 1986). In a follow-up study tA 2,009 post-treatment opiate addicts, 56 percent to 77 percent had resumed daily use at one year post-treatment (the varience occurred due'to individual measurement of treatment groups) (Simpson & Sells, 1982).

A comparison of the longitudinal studies (i.e., studies that have followea 1 dlCohol and Opiate Clients for a period of five years or longer afIer the initial treatment episode) again shows a significant similarity in patterns.

. 68 Enclosure A l

4 .

y For the majority; of individuals, multippe episodes of' relapse are followed by- j

- periods' of abstinence -(Maddux and. Desmond,- 19E6; Simpson and Marsh,1c86).

- However, the most critical finding suggests thct- while multiple episodes of theJ

' abstinence / relapse cycle tend to occur, relapse does decrease us the period of.

abstinence increases (Simpson and Marsch,1986). ,

j Although there are fewer studies of other drug types, what research has been -

conducted,' suggests that relepse patterns tc other substances are sin.11ar to those for alcohol a'nd opioids. A further study conducted by Hubbard and Marsden (1986) compared the relapse. rates of four drug categories: heroin, other narcotics, cocaine,'and other non-narcotics which include amphetamines, sedatives, barbiturates, and the minor tranquilizers.

The study reviewed the

post-treatment history.of 2,280 clients, rondomly selected f rcm al different treatn:ent facilities repr.esenting the full spectrum of treatment ' modalities (i.e., methadone maintenance, detoxification, therapeutic corrmunities, Y

~ inpatient facilities, out-patient drug f ree counseling). The timing of relapse.

was similar for all four categories. Two-thirds of those who relapsea did so within the first. 90 days af ter . leaving treatment. A widely cited study that reviewed relapse rates.over 12 months followi g treatment showed that smokers, alcoholics, and hercin addicts are alike in beving relapse rates greater than 50 percent in the first three months post-treatment, and 60 percent relapse within the first' yea [ post-treatment (Rounsaville,1986).

In summary, the literature suggests that patterns of relapse may be consistent across drug types among substance-dependent individuals. It is critical in the interpretation of the relapse and recovery literature to understand, however, that the primary focus of study has been the seriously dysfunctional alcoholic or drug abuser. The reasons for this are several. First, alcohol and opiate dbuse have been the focus of the community-based treatment systera, and a high percentage of the individuals who elect to participate in publicly fundad treatment are diso recipients of public assistance. The eniployed and educated middle class with employer-paid medical benefits have typically sought treatment in private facilities or with private practitioners. Private facilities, unfortunately, generally do not participate in published research.

Hence, most of the research literature is based upon the publicly funded client, and may not directly apply to the types of individuals employed in the 69 Enclosure A o ,

l  !

i

,5 nuclear industry. As will be. discussed below, however, there are a number of l'j factors that may contribute to the effectiveness of treatment for individuals )

with unescorted access that are not present for seriously dysfunctional substance abusers. Thus, although relapse to substance abuse is likely fo'r i

. dependent individuals ana can occur at any time post-treatment, there is evidence to suggest that early detection cf a developing substance abuse problem and treatment may prevent relapse among nuclear workers, i

C. Treatment effectiveness.

Within the context of the substance abuse cycle, treatment remains the most

~

likely means by which the successive cycle will be broken. As mentioned above, treatment may also serve to prevent relapse in these individuals whose substance abuse problems are still in the developing st! age.

1. '/

The effectiveness of treatment is well accumented, although it remains unclear ,

as to why treatment wcrks. Numerous longitudinal studies have shown that pre-treatment levels.of substance abuse are gererally higher than those of post-treatment abuse (cf,. Jaf fe,1984). Consequently, the goal of the NRC to ensure fitness for duty will be enhanced by treatment.

Of particular importance to the NRC is the suggestion by the treatment literature that the critical factor in obtaining a positive outcome is not the type of treatment, but the amcunt of treatment contact (Simpson, 1984; Senay, 1984). In fact, several large-scale treatment follow-up studies have shown j that the treatment cutcomes for those participating in such diver:;e treatment protocols as outpatient drug-free counseling, methacone maintenance, and therapeutic comunities are statistically indistinguishable (peunsaville,1986, Simpson,1984).

Although the evaluation of treatment effectiveness is regarces by the research community as in an evolutionary stage, several factors associated with positive outcomes have been identified. The most powerful determinant appears to be the ,

individual's commitmt.nt to treatment and the recevery process (Simpson,1984; Tims and Leukfeld, 1986). Secondly, the therapeutic process itself can

- 70 Enclosure A

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[ ..

o t

l directly impact the treatment outcome. To be effective, the process should I

incorporate the individuel's coninitment to chance, sustain the commitmuit, and translate it into action (Sin.pson,1984), Third, the length of tine in treatmer.t has also been identified as a factor, with longer participation in treatment being positively related to trectment outcome (Simpson, 1984; Tims and holland, 1984; Hubbard, et al., 1984).  ;

i i

Ir. addition to the verious factors associated with treatment, there are several

l. personal characteristics of patients that are associate' d with a positive l treatment outcome. These factors include o stable family background, an intact marriage or relationship, a stat,le and supportive job situation, minimal involvement with the criminal justice systert, erd limited psychological prct lems. Higher socioeconomic status is also e predictur. Those clients with the ledst severe problems, and the grtatest social and psychological assets, i tend to habe the best prognosis (Gcccwin, 19E8; Rounsavi;ie, 1986). While the typical worker within the nuclear incustry car:not be assumed to have all cf these characteristics, some or most will be applicable to licensee employees. hW In summary, it appears that the progr.csis for rehabilitation emong licensee employees may be quite' positive. The NRC believes that the utilitit.s should en.ptcsize these factors where appropriate to secure the greotest probabliity that un employee will remain drug free and nct place public health ccd safety i dt risk in the future.

D. Development of the treatment, follow-up and future employment plans.

l During the period that unescorted access is withdrawn following the initial i findinc of a substance abuse disercer, the licensees shculo carefully assess the nature of the indivicual's schstance abuse problen:, and develop appropriate treatment, follcw-up and employment plans. The goal of this process is tc assure that the individual will regain unescorted access only after determination that he or she 'is fit for cuty, and that the risk is minimal that the indivicual will pose u future threat to public safety.

71 Enclosure A

Prompt response to an initial confirmed positive test result in the form ofca treotment and employment plan is likely to be effective in. resolving. substchce abuse problems among the types of persons grantec unescorted access.

.The NRC recognizes that the evaluation of a substance abuse-problem involves numerous factors unique to the indivicual, and that this task is appropriately left to the: trained judgment of a medical professional qualified in substance-abuses 01sceders. Consequently, 6ny individual receivir.g a. confirmed positive test' result who isl retaired for potential ret' urn to unescorted access, will be referred immediately to the EAP for astessment of the substance abuse problem 1 and formulation of treetment, follow-up and future employment plans. Since the success of this effort is contingent upon the reliability of the assessment, the' NRC expects thet each utility will engage qualified individuals for evaluating substance abuse problems. Additionally, the assessment prccess should utilize assessment tools that specifically identify the nature and extent of the individual's substance abuse problem._ The diagnosis shoulo g tf directly trigger the development of the treatment, follow-up, and empicyee I

plans.- .

. l To be most. effective, the treatment plan should be designed to meet the spec 1fic needs.of the inoivicual, giving consideration to the various facters discussed above. Incividual attention is especially critical in.the light of ,

1 the various possible meanings of a confirmed positive test result. The NRC recognizes that a positive test can indicate any stage of substance abuse along the substance abuse cycle. Fur example, an appropriate treatment plan for u

" recreational" user might require the completion of the EAP assessment and additional designated hours of drug education. Treatment may not be necessary. b, e

insteaa, it may be more effective to place an emphasis on follow-up random drug 1 testing (e.g., a weekly rate initially, graduelly decrecsed to monthly for at least one year) ano periodic EAP contact (e.g., sufficiently frequent ever an-appropriate period to achieve high confidence that the problem has been j resolveo). Under this approach, the employment plan woulo include a return of 1

unescorted access authorization at the end of the two week revocation perico, with minimal risk to plant safety.

72 Enclosure A

O r

At the.other end of the spectrum, an appropriate treatment plan for an 1ndividual experiencing substance 0huse dependency will be acre complex. In this case, the- EAP wculd likely make a referral to an inpatient faciiity, and +

the individual would not be ellowed to regain unescorted access until inter.sive

= rehabilitation is completed. While several studies have suggested that

. emphasis shou l d be lp aced on the length of treatment and not on the treatment type, these same stLdies further suggest sig .i;cantly poorer outcomes for seriously dysfunctional individuals who receive et. assessment only, withcLt additional treatment, or who receive detoxification only, without additional counseling (Simpson and Marsh, 1906). More extensive trectment involvement appears to be necessary for the'e indiviou&ls. .

. i Licensees should place emphasis an the development of a follow-up plan, ga Assurances cannst be made that pu nt safety is maintained unless the indiviaual's progress is monitored once he or she has regained unescorted I access. The relapse and recovery literature stresses the importance of af ter-care and follow-up monitoring to prerent relapsti. flecause the critical period for relapse falls during the first 90 days, frequent contact by the EAP, possibly weekly, will best assure that the individual continues to remain substance free. However, because most individuals who relapse do so within the first year, the follow-up plan should also provide for continued' EAF contacts following the first 90 days, with decreusing frequency to perheps one contact $

per month. Follow-up random testing, intensely at first, with gradually 7

-decreasing frequency as the patient progresses through the critical 90 day ard one year periods and beyond to achieve a high confidence of full reccvery, should also be emphasized in all follow-up plans. Follow-up testing will also l serve to assure that the goal of public health and safety cor,tinues to be met, j The employment plan should be based upon any limitations that need to be placed on the individual being returned to work. The plan should help the ,

inaividual's supervisor ur.derstand what his role is in the follow-up plan, and set conditions for full restoration to duty, where appropriate. To test and evaluate the individual's substance ebuse disorders, develop the plans, and obtain essurances that an individual does not constitute a potential hazard to 73 Enclosure A

, . .= -

,, 4 H ,

9 f-l safety (in the case of a "recreatienol" ~ user), should be accomplished-within f-

two weeks.

j

~

1, 4

In sumary, the imC expects the two-week minimum mandatory revocation period to be used by the. utilities in the'follewing manner: Each individual receiving a g first positive test result will be referred to the EAP for assessment of his or j her substar.cc abuse'. problem. The assessment will direct the' development of the

{

treatment and employment. plan, which should-be designed to n,eet the individual's scecific fitness-for-duty needs.. Finally, the precess will be completed with the: development of-a follow-up plan that specifies the frequercy of EAP contact and-follow-up random drug testing.

• Section-by-Section Analysis I

The generel objective of fitness-for-duty programs is to provide reasonable  ;

assurance that nuclear power p;lant personnel are not under the influence of any # {+ Lj substance, legal or illegal,. or mentally or physically-impuired from any cause, 4/5 I which in any way affects their ability to safely and competently perform their duties. To accomplish this objective, the Commission is proposing to amenc its regulations by adding a new Part 26 to Title 10, Code 'of Federal Perclations.

The following section-by-secticn analysis of the principal sections provides additional explanatory information.

Section 26.2 Scope This section sets cut the Comission's proposal as to the employee and

- contractor population to whom the regulation, including ranoom testing applies.

To achieve the general objective, the Commission proposes that the rule apply to all persons with unescorted eccess to protected areas, and to licensee or contractor personnel required to respond to the licensees i Technical Support Center (TSC) or Emergency Operations Facility (E0F). The rule would apply to these latter categories of personnel because of the potential impact on pubilc 74 Enclosure A <

.4 health and safety that could arise from human fc.ilure on their part. The rule cpplies to all persons with unescorted access te protected areas becaute- l Current programs are implemented in accordance with the Commission's Policv Statement (51 FR 27921) which applies to all persons within .

protected areas at nuclear power plants.- gg!

Such persons could introduce enc sell drugs in the workplace.

Ar.y such perse,' under the influence of any substar.ca could cause n sdfety hazard, if not to the general public, to him or herself ane to fellow wurkers. l Section 26.10 General performance objectives This section is intended to facilitate proper it.aragement of fitness-for-duty programs by establishirig clear prcgram goals.

Although titriess-for-duty prograriis are intended to provice reasonable assurance that individuals are not using or under the influence of any substance, or mentally or physically impaired from ar?y cause that could adversely affect safety, the specific program elements and procedures contained in the proposed rule apply only to drugs. Specific nreasures for addressing abuse of alcohol, and legal drugs (prescription and over-the-counter) are to t,e developed by each licensee. Other factors that could affect fitness for duty such as mental stress, fatigue and illness are also expected to be addressed by licensee #/ I programs.

In this regard, the proposed rule dees not specifically address the offsite sale er possession of drugs, the offsite use of drugs cetermined by means other then chemical testing, atteripts to introduce alcohol or drugs oncite, nor .vhat actions shculd be taken for drug ev(nts in the owner controlled area.

Licensees are expected to take prudent measures to identify and correct such problems. These measures, at a minimum, should include for-cauce testing, utilization of the access authorization program, and appropriate investigations i

1. /g 75 Enclosure A

l _

'and searches. furthermore, licensees are expected to properly manage-their programs"and include elementsisuch as aucits and analysis of records to provide-

.tesdback on program performance.

e ilhe specific re_quirements described in'the Program Elements and Procedures sections of the. proposed rule are'not intended to prchibit any licensee fron i adoptingLar.o enforcing more stringent.stondards.

'Section 26.20 Written policy and procedures

.This section requires the establishment and implementation of written' policies and procedures to ensure that all persons clearly understand what is expecteo of them and what consequences may result from violation of company policy.

Section 26.21 Policy conaunication and awareness training

'This section requires. appropriate training to ensure unders*anding cf the policy, how the pr,ogram will function,'and the hazards associated with abuse of drugs.- This _section is intended to ensure that all persons understand and-support the program and its implementation.

Section 26.22 Training pf supervisors and escorts This section requires appropriate training of managers, supervisors and escorts to ensure they understond their role in the implementation of the titr,ess-for-duty program, to ensure that they are sufficiently skilled to.

detect conditions that arise from abuse or presence of drugs, and to ensure that the proper acticn is initiated.

This section includes. training in behavioral obst.rvation techniques whch are also expecteo ur.cer the proposea Access Authorization Progran, pelicy statement.

(53 FR 7534). The NRC staff will ensure that the expectations in the proposed' policy statement and the implementing industry guidelines and the requirements in this proposed rule ore compatible prior to publication of any final rule in the Federal Register, i

76 Enclosure A .

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Section 26.23 Contractors-This section' requires that contractor personnel be subject to,.and 6 bide by, a-fit' ness-for-duty program. Furthermore,' contractors are required to not assign any personnel previously removed from any other nuclear power plant without the knowledge and' consent'ef the licensee.

Section 26.24. Chemical testing This'section requires that chemical testing be conoucted to deter and detcet drug abuse. The testing is required because the Commission 1s concerned with the possible impact on public health and safety if individuals ::aose reliability is questionable because of impairnie.nt due to the u<.,e of drugs, are permitted to perform important tasks, such as manipulating control mechanisms or' conducting maintenance on facility equipment or systems. Tests'would be required: ,

Immediately before the initial granting of unescorted access to protected areas or assignment to activities within the scope of this part.

On a rancom basis; adjusted each month to increase the percentage of the populaticn being tested once per yeur and maintain a low percentage of b,,,

individuals tested more than once in a given year.

For-cause; and As a follow-up to verify abstention.

For-cause testing is required after accidents involving actual or potential substantial degradation of the level of safety of the plant. This is the level of event characterized by an " alert" emergency classification.

This- section acepts the " Mandatory Guidelines for Federal Workplace Drug Testing Programs" issued by the Department of health and Human Services as minimum' standards for procedures for collecting and testing of specimens and for er.suring the integrity of the testing program. This section also adopts the HHS standards for " Certification of Laboratories Engagea in Urine Drug Testing for Federal Agencies." Licensees would be permitted to conduct

.. 77 Enclosure A j

~

L preliminary tests to reduce the number of specimens- forwaroed to a contract laboratory for initial screening tests and confirmatory tests.

This'section requires, through the HHS guidelines, that a medical review officer review and interpret positive, confirmatory test results.

Section 26.25 Employee Assistance Programs (EAP)

This section requires licensees to maintain an EAP designec to achieve early intervention and to encourace self-referral. This section stipulates that confidentiality shall be extended, except where safety considerations must prevail. In this regard, any licensee receiving direct or lodirect federal financial essistance in any form, which may include rever.oe sharing er tax-exempt status,tcay be' required to maintain confidentiality of crug abuse patient records in accordance with 42 CFR Part 2. Althcugh this lew is intended to ensure that an alcohol or drug abuse patient in a f ecerally assisted alcohol or drug abuse program is r,ct made more vulnerable than a person who does not seek trectment, the determination of whether federal assistance is provided is much broader [42 CFR 2.12(b)]. Licensees who find that 42 CFR Part 2 applies, should inform the Commission and propose a method to acccmplish' the goals of the reovirements set forth in the proposed rule.

Section 26.27 Management actions and sanctions to be imposed This section requires that management:

Complete a suitable inquiry, i.e., verification of employment history, py gg-to determine it any person was ever removed from activities within the scope of the proposed rule or denied unescorted access due to not being fit for duty.

As a minimum, remove from activities within the scope of the propesed rule for at least 14 days, and during any suspension period, refer for ,

j assessment and counseling thuse persons having their first confirned positive test. Treatment, follow-up and future employment plans must be di8' developed, and any rehabilitation program deemed appropriate must be j l

J l

78 Enclosure A

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initiated, during such suspension period. Assurance of fitness must be obtained prior to return to duty. $ Y' [

Remove from activities within the scope of the proposed rule for a minimum of three years, those persons having a second confirmed positive.

• Not assign to activities within the scope of the proposed rule for a minimum of five years, those persons determined to have been involveo in the' sale. 'use, or possession of illegal drugs within a protected area.

Permanently deny unescorted access to those persons, who, having been 3 restored unescorted eccess after the above three or five year period,, jgf are subsequently found to be involved with illeeal drugs.

Section 26.28 Appeals

.This section requires that there be an oppeal process in accercance with due process and fundamental fairness considerations so that adverse fincings as a l

result of the required testing program may be subject to further review at the instigatica of the person aand to test positive for proscribed substances.

Rather than dictate what that appeal procedure should be, the Corrinission has-limited itself to proposing that there be an apr>eal procedure and notes that the grievance procedures contained in collective bargaining agreements may be suitable.  !

Section 26.29 Protection of information This section requires the licensee to ensure that personal privacy is protected to the extent possible, consistent with the need to carry out the fitness-for-duty program. Acceroingly, specific exceptions to the information disclosure l prohibition are provided. This list of exceptions is considered to be inclusive and no other disclosures should be made. If disclosure of the l information is necessory for emergency medichl purposes, it is assumed that the  ;

1t.dividual, or his/her representative, can provide the basis for such release.

Regarcless, it is not the inter.t of this provision to it, cny way create potential harm to anyone through nondisclosure during a medicel emergency. It should be noted 'that 42 CFR Part 2 may prohibit licensees that receive federal financial 6ssistance, from cisclosing information to another licensee regarding )

l

. 79 Enclosure A 1

I

the nature of. a' person's problem,. if that person sought assistance on his owr 4 initiative.

Section 26.71 Recordkeeping requirements This section requires licensees to retuin records to facilitate inquiries to determine if a person had been made ineligible for essignment to activities g lI within the secpe of'10 CFR 26. This section also requires licensees to collect, compilo and analyze program perfornence data and to take appropriate actions to correct any program weaknesses so identified. The collection are analysis of data is believed important for the following reasons:

Although the proposed rula woulc require elements that constitute an effective program based on current information, fitness-for-duty programs I

are part of an evolving discipline; and lessons learned and advances in technology may warrant future; revisions to the programs. The collection and analysis of'cata would support any future Considerations in that regard, e.g., to add, relax, cr strengthen a specific requirement. The-program performance data would allow for empirical evaluation of alternative strategies. gg It .is expected that some utilities will have elements of their overall i fitness-for-duty program that differ from and/or exceed the minimum [

requirements of the rule. If performance data are available, the NRC could evaluate whether these other program characteristics are f contributing to or detracting from the program goals.  !

Trend analysis of the data would facilitate appropriate inquiry should there be indications of any problems, such as a possible failure in program design or implerrentation.

The hRC developed a list of cata that appear to be appropriate based upon informed reviews by appropriate professionals in other organizations. To ensure consistency of cota and to facilitate analysis, a draft form accompanies the proposed rule. The Commission may request the data on an as-needed basis. W /g l 80 Enclosure A

4

?

Section 26.73 Reporting requirements lhis section requires licensee to inform the Cchmission by telephcre, within 24

. hours of discovery, of all significant fitness-for-duty events, including:

sale, use, or possession of illegal drugs within the protected area, any acts involving the illegal sole, use or possession of a controlled substarice (onsite or offsite) by any person licensed unoer 10 CFR 55 to M(

operate a power redctor or by any supervisory personnel assigned to ,(

perform duties with the scope of this part. This includes the results of l) conf 1rtred positive tests on such persons.

Written reports are required within 30 days documenting such notifications and specifying actions taken. j Section 26.80 Audits 4 /d This section requires licensees to audit their fitness-for-duty program, including those sections implemented by contractors, end to take appropriate actions in response to the audit findings.

Bibliography I DRUG USE AND IMPAIRMENT Agurell, S. L., Hollister, L. E. 1986. "Pharmacokinetics and fietabolism of Delta 9-Tetrahydrocannabinol: Reletions to Effects in Man." Alcohol, Drugs, and Driving. Vol. 2, No. 3-4. July - December,1986.

Ambre, et i.l. (To be published in 1988). " Acute Tolerance to Cocaine in Humans." Mariuscript provided by author.

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P Blum, K., 1984. Hanobook of Abusable DruSs. Gardner Press. New York / London.

Brady, et al . ,1986. "Behevioral Interactions and the Effects of Merijuana."

Alcohol, Drugs, and Driving. Vol. 2, No. 3-4. July - December, 1986.

Byck, R., 1987. "The Effects of Cocaine on Complex Performance in Humor.s."

Alcohol, Drugs, and Driving. Vol. 3, No.1. Jan.uory - March,1987.

Chait, L. D., Fishman, M. W., and Schuster, C. R., 1985. " Hangover Effects the Mcrning Atter Marijuana Smoking." Drug and Alechol Depenococe, 15, 229-238.

Chesher, G. B. 1986. "The Effects cf Alcohol and Varijuara in Combination: A Review." Alcohol, Drugs, and Driving. Vol. 2, No. 3-4. July - December 1986.

Cluouet, D. H., ed. 1986. NIDA. Research Monograph 64. "Phencyclidine: An Upoate." Department of Health and Human Services.

Cohen, S., 1986. " Effects of Long Term Marijuana Use." Alcohol, Drugs, and Driving. Vol. 2, No. 3-4. July - December,1986.

Cohen, S., 1986. " Marijuana and the Connobinoids." Drug Abuse and Drug Abuse Resea rch. The Second Triennial Report to Congress from the Secretary, Department of Health and Human Services.

Cook., 1986. " Analytical Methodology for Delta 9-Tetrahydrocannabinol and its Metabolites." Alcohol, Drugs, and Driving. Vol. 2, No. C-4. July - December, 1986.

Davis, M., 1985. "Cocaire: Excitatory Effects en Sensorimotor Reactivity Measured with Acoustic Startle." Psychopharmacology, 86(1-2),31-36.

1 DuPont, R. L., " Cocaine in the Workplace: The Tickir,g Time Bomb." In:

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. 3

..+-

1 DuPont, R. L., 1984. "Getting Tough on Gateway Drugs: A Guide for the-Family." Washington, DC: The An.erican Psychiatric Press.

Fehr. K. O., Kalant, H., ed. 1983. " Cannabis and Health Hazards: Proceedings of an ARF /WHO Scientific Meeting on Adverse Health and Behavioral Consequences of Cannabis Use." Addiction Research Foundation, Toronto.

Fischman, M. W. "1he Behavioral Phartracolog of Cocaine in Humans." See Grabowski, J.,'ed. 1984. N1bA. Research Monograph 50. " Cocaine:

Pharmacology, Effects, and Treatment of Abuse." Department of Health arid Human i Services.

Frank, R. S., 1987, November / December. " Drugs of Abuse: Data Collection Systems of DEA and Recent Trends." Jourr.al of Analytical Toxicolcgy. Vol. 11, No. 6.

Gawin, F. H., Kleber, H. D., 1986. " Abstinence Symptomology and Psychiatric Diagnosis in Cocaine Abusers." Archives of General Psychiatry 2 43, 107-113.

Grabowski, J., ed. 1984. NIDA. Resecrch Monograph 50. " Cocaine:

Pharmacology, Effects, and Treatrrierit of Abuse." Dcpartment of Health and Human Services.

Greaves, G. B., 1980. " Psychosocial Aspects of Amphetamine and Related Substance Abuse." In: Caldwell, J., ed. 1980. Amphetamines and Relateo Stimulants: Chemical, Biological, Clinical, and Sociological Aspects. CRC Press. Boca Raton, Florida.

Hawks, R. L., ed. 1982. NIDA. Research Moncgraph 42. "The Analysis of Cannabinoids in Biological Fluids." Departrrent of Health and Human Services.

Holbrook, J. M., 1983. " Hallucinogens." In: Bennett, G., Vourakis, C.,

Woolf, D., eds., 1983. Substance Abuse: Pharmacological Developmental, or.d Clinical Perspectives. New York: John Wily & Sons.

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["

Holbrook, J. M.,:1983. "CNS Stimulants." I'n: Bennett, G. , Vourakis , C. ,

-Woolf, D., eds. 1983. Substance Abuse: Pharrucological Developmentui, anc Clinical Perspectives. New York: Jchn Wily & Sons.

Janowski, D. S., Meacham, M. P., Blaine, J. D., Schoor, J., and Bozzetti, L.

P.,1976. '" Simulated Flying Performance efter Marijuana Intoxication."

Aviation, Space and Environmental Medicine, 47:124-128, 1976.

l Jones, R. T., "The Pharmacology of Coccine." See Grabewski, J. , ed.1984.

l NIDA. Research Morsgraph 50. " Cocaine: Pharmacology, Effects, and Treatment oi Abuse." Department of health and Human services.

Jones, R. T., "The Psychopharmacology of Cocaine." See Washton, A. M., Gold.

M. S., ed. 1987. Cocaine: A Clinician's Handbook. Guilford Press.

New York / London.

Klonoff, H., 1984. " Acute Psychological Effects of Marijuana in Man, Including Acute Cognitive, Psychomotor, und Perceptual Effects cn Driving." See Fehr, K.

O., Kalant, H., ed. 1983. " Cannabis anc health Hazards: Proceedings of an ARF /WHO Scientific Meeting on Adverse Health and Behevioral Cor sequences of Cannobis Use." Addiction Research Foundation, Toronto.

Marwah, J., Pitts, D. K., "Psychophormacology of Phencyclidine." See Clouet, D. H., ed. 1986. NIDA. Research Moncgraph 64. "Phencyclidine: An Update."

Department of Health and Human Services.

McBay, A. J., 1986. " Drug Concentrations and Traffic Safety." Alcohol, Drugs, and Driving. Vol. 2, No. 3-4. July - December, 1986.

Vottat, et al., NIDA. Research Monograph 42, 1981. Department of Health ano Human Services.

l l Moskowitz, H., 1985. " Adverse Effects of Alcohol and Other Drugs on Human Performance." Alcohol-Health and Research WorId. Summer 1985. Vol. 9, No. 4.

. 84 Enclospre A i

_ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ -- _ _ _ . - _ _ _ - . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ ____ __J

.s Murray, J. B., 1986. "liarijuana's Effects on Human Cognitive Functions, Psychomotor Functions, eno Personality." The Journal of Gereral Psychclogy, 113(1),23-25.

O'Hanlon, J. F., deGier, J. J., 1986. Drugs and Driving. Taylor & Francis.

London and Philadelphia.

Peck, et al., 1986. "The Effects et Marijuana and Alcohol en Actual Driving Performance." Alcohol, Crugs, and Driving. Vol. 2, No. 3-4 July - Decen.ber, 15'66'.

Podolsky, D. M., Richards, D., 1985. " Investigating the Role of Substance Abuse in Occupational Injuries." Alcchol Health and Research World. Summer 1985. Vol. 9, No. 4.

Radford, et al., 1983. " Drug and Alcohol Abuse: The Bases for Employee Assistance Programs in the Nuclear Utility Industry." NUREG/CR-3196, PNL 4679, BHARC 400/83/003.

Ross, L. E., Ross, S. M., 1985. " Alcohol and Drug Use in Aviation." Alcohol Health and Research World. Summer 1985. Vol. 9, fio. 4 Schwartz, R. H., Hawks, R. L., 1985, August 9. " Laboratory Detection of Marijuana Use." Journal of American Medical Association. Vol. 254, No. 6.

Siegel, R., 1987. " Cocaine Use and Driving Pehavior." Alcohol, Drugs, and Driving. Vol. 3, No. 1. January - March,1987.

Smiley, A., 1986. " Marijuana: On Road and Driving Simulator Studies."

Alcohol, Drugs, and Driving. Vol. 2, No. 3-4. July - December, 1986.

Smiley, A. M., Moskowits, H., Ziedman, K. " Driving Simulator Studies of Marijuana Alone and in Combination with Alcohol. In: Proceedings of the 25th Conference of the American Association for Automotive Medicine, San Francisco, CA, 1981. pp. 107-116.

85 Enclosure A. .

4

~

[Stitzer, M. - L.- . ' " Social Stimulus Factors in. Drug Effects in Human Subjects."'

. Thompson, T., Johanson, C.;E., ed. 1981.- NIDA. Research Moncgraph 37.

'" Behavioral Pharmacology of Human Drug Dependence." Department' cf Health and iHuman Services.

[ Stone,N.,Fromme,'M.,Kagan,D.,1984. Cocaine. ' Seduction and Solution. New Clarkson N. Potter.

. Yor k:'

-Sutton..L'. R.,'1983.

"The Effects of' Alcohol, Marijusna, and their Combination on Driving Ability."' -Journal of Studies en Alcohol. ~44:438-445,.1983.

.W alsh, J.'M., 1987. " Drug Effects on Human Performance: NIDA Research Programs." Alcohol,- Drugs, and Driving.- Vol. 3, he. 1. January - March,

-1987.

.'Walsh,.J. M., Yohay, S. C., 1987. " Drug ano Alcohol Abuse in the Workplace: A Guide to the' Issues." National Foundation for the Study. of Equal- En.ployment .

Policy. Washington, DC.

Washton, A. M., Gold, M. S., ed. 1987. _ Cocaine: A Clinician's Handbook.

Guilford Press. New York / London.

Wecif, D. S.. 1!83. "0pioids." In: Bennett, G. , Vourakis, C. , Wl f, D. S. ,

eos. 1983. Substance Abuse: Pharmacological Developmental, and Clinical Perspectives. New York: John Wily & Sons.

II ALTERNATIVES TO URINALYSIS

' Anonymous. 1985, Ncv. 8. " Consensus Report: Drug Concentrations ano Driv 1nc Irpairment." Journal of the American Medical Association. Vol. 254, No. 13.

pp.-2618-2618.

j I-I l

86 Enclosure A I

I w -

Balster, R. L., " Clinical Implications of Behavioral Pharmacology Research on Phencyclidine." See Clouet, D. H., eo. 1986. NIDA. Research Monograph 64.

"Phencyclidine: An Update." Department of Health and Human Services.

Balster R. L., Wessinger, W. D., 1983. " Central Nervous System Depressant Effects of Phencyclicine." In: Kamenka, J. M. , Domino, E. F. , and Geneste, P., eds. Phencyclidine ano Related #rylcyclohexylamines: Present and future Applications: HPP Books, 1983.

- Baumgartner, W. A.; B16ck, C. T.; Jones, P. E.; Ciahs, W..H., 1982.

"Redioimmunoassay of Cocaine in Hair: Concise Communication." Journal of Nuclear Medicine. Vol. 23. pp. 790-792.

Cadoy, B., 1984. "Salive as a Specimen for Drug Analysis." Advances in Forensic Toxicology. Biomedical Publication. p. 198-254.

Caldwell , J. , 1980. " Amphetamines and Related Stimulants: Some Intrcouctory Remarks." In: Calwell, J., ed. 1980. Amphetamines and Related Stimulants:

Chemical, Biological, Clinical, ano Sociological Aspects". CRC Press.

Boca Roton, Florida.

Dogoloff, L. I.; Angarola, R. T. ; Price, S. C. , (eds. ). 1985. Urine Testing in the Werkplace. Rockville: The American Council for Drug Eoucation.

Ellinwood, E. H., 1971. " Assault and Homicide Associated with Amphetamine Abuse." American Journal of Psychiatry, 127, 1170-1175.

Ellinwood, E. II. , Ni kaido , A. M. ,1987. " Stimulant Induced lapoirment: A Perspective Across Dose and Durotion of Use." Alcohol, Drugs, end Drivinc.

Vol. 3, f!c. 1. Janua ry - March,1987.

Hawks, R. L., (ed.) 1982. "The Analysis of Cannabinoids in Biological Fluids."

NIDA. Research Monograph 42. DHHS Pub No. (ADM)82-1212. Washington, DC:

U.S. Printing Office.

1 1

87 Enclosure A

Hurst',nP.L1987.' " Amphetamines.and. Driving." Alcohol, Drugs, and, Driving.

?Vol. 3, No. 1.: January - March,1987.

Jain,-N.;C..'Budd, R. D., Budd, B., 1977. " Growing Abuse of Phencyclidine:

. California Angel Dust." New England Journal of Medicine. 297: 673, 1977.

Lerner, S. E., Burns, R. S. " Legal Issues Associated with.FCP. Abuse - The Role E

of the: Forensic. Expert."' See Clouet, D. H.,-ed. 1986. NIDA. Research Monograph'64; "Phencyclidine: An Update." . Department of" Health and'Humsn

-Services.

Nelson and Moffat, 1980. " Detection and Identification of Amphetamine and Related Stimulants." In: Calwell, ed. 1980. Amphetamines and Related Stimulants:/ Chemical, Biological, Clinical, and Sociological Aspects." CRC Press, Inc., Boca Raton, Florida.

Puschel, K.; Thomasch, P.;, Arnold, W.;;1963. " Opiate Levels in Fair."

Forensic' Science: International. Vol. 2, pp. 181-186.

-Walsh. J.'M.; Yohay, S. C., 1987. Drug and Alcohol Abuse in the Workplace1 A Guice'to the Issues. Washington, DC: National Founcction for the Study cf Equal Employment Policy.

-Washton, A.; Golo, M. (eds.)..

1987. Cocaine: A Clinicians Pancbook.

New York: Guilford Press.

III' ALTERNATIVES TO RANDOM TESTING

' Anonymous. -1966, September 27. " Drugs at Work." The Economist. Vol. 7465.

p. 27.

Anonymous. 1987, June 1. " Clinical Chemists Group Surveys Drug Testing."

Chemical Engineering News. Vol. 65, No. 22. p. 6.

88 Enclosure A i

w -

y:

LBaloh, R.B. ," Sharma , S. . : Mos kowi tz, H;, : &' Gri ffith, R. , - (1979, January) .

L Effect .cf Alcohol:and Marijuara on Eye Movements. Aviaticn, Space and 4

, Environmental Pedicine, 18-23.

' Bureau'of National Affairs Inc., Daily Labor Report. 1987. June 17: a-13.

Eurns,: M. . (1987).: Sobriety Tests'for the Presence of Drugs. Alechcl,' Drugs Tand Drivino, 3(1 ), : 25-29.'

Castro, J.,'1986, March.17. "

Battling:the Enemy Withir,." 'T1me. Vol. 127', No.. .

11'. pp.c40-46.

Council on' Scientific Affairs. 1987. " Issues in Employee Drug Testing."~

cJournal of~the American Medical Association. Vol.'258, No. 15. pp. 2089-2096.

-Englund, et al., (Unpublished) United Tri-Service Performance Assesscent Battery

'(UTC-PAB). Report No. 87-10,, supported by;the Joint Work 1 rig Group on Drug Dependent- Degradation ir. hilitary Performance. (JWGD3 MILPERF) under Army work Unit'No; 63764A 3M463764B995.AB-087 and Naval Medical Research cnd Development-Command, Bethesda, MD..

1 Gaeta E., 1982', May/ June. "AT&T Looks at Program Evaluation." EAP Digest.

pp. 22-31.

' Gam, J. ; Sauser, 'W. I. ; Evans, K. L. ; and Lair, C. V. ,1983, September. "The Evaluation of an Empicyee Assistance Program." Journal of Empicyreent

~Qunseling..Vol.20,No.3'.pp.99-106.

Gates, D. F. (1985).

Drugs on the Road: Zv.roing in on Highway Terror.

Police Chief, 52(7),67-69.

~

. Good, G. W. , . & Augsburger, A. R. (1986). Use of Hgaze Nystagmus as c La Part'of- Roadside Sobriety Testing. Arr.erican Journal of Optometry &

' Physiological Optics _, g (6), 467-471.

p

l. e L

89 Enclosure A J:2__--- - -___ - _ _. i

jf + < r L. .Goodwin, Donald W.,i1988. "Alcoholisra: .Kho Gets Better and Who Does Not;"- In

. Rose, LRobert 'H. and Jarres E. . Barret (Ecs. ), Alcoholismi Origins _and Dutcome. -

New Yorki Raven Press.

a ;Gregoire, K. C.. 1979, January. "An Evaluation of Several Aspects of- a Consortium Employee Assistance Program." Dissertation-Abstrdcts International:

U Nebraska, Lincoln.- Vol. 39 (7-B).3567.

.Hanson.fD. J., -1987; " Drug Abuse Testing Programs Gaining Acceptance.in Workplace." _ Chemical and Engineering -News. Vol. C4, t'o. 22. pp. 7-14.

Hawks, R. L.; Chaing, C. N., 1986. " Urine Testing for Drugs of Abuse " Research Monograph 73;-il6tional Institute of. Drug Abuse.

Hoffman, E.; Roman, P. M., 1984, May. " Effects of Supervisory Style and Experimentally based Frames of Reference on Organizational Alcoholism Programs.'! Tulane U. Newcomb Coll Journalt of Studies on Alcohol. Vol. 45, No..

3. pp.'.260-267.

'Hoffmen, N. G., Harrison, P. A., 1987, March. " Patient Variations in Alcohol Tredtment Utilization." Eusiness & Health. Vol. 4, No. 5. pp. 16-18.

. Hubbard, Robert L., S. G. Craddock, and Elizabeth Cavanauch,198a. " Treatment Outcome Prospective Study (TOPS): Client Characteristics and Behaviors Before, During, and After Treatrrent." NIDA MON 0 GRAPH #51.

Kennedy, R. S., Turnage, J.T. and Lane, N. E. (1988). Application of a  ;

Portable Microcomputer. Mental Acuity Battery for Fitness-for-Duty Assesunent in Power Plant Operations. Ess.ex Corporation report presented at 1988 IFEE Fourth Conftrence on Human Factors es,o Power Plants, Monterey, CA: June 5-9, 1988.

Mdsi, D., 1987, March. " Company Responses to Drug Abuse from AMA's Naticr. wide Survey." Personnel. Vol. 40. pp. 40-46.

1 i

90 Enclosure A l

McClellan, K.1984, October - December. " Work-Based Drug Programs. Tri-County .

Employee Assistance Program, Akron." Ohio Journal of Psychoactive Drugs. Vol.

16, No. 4. pp. 285-303. i Martin, D. W.; Heckel, V. M.; Long, R., 1984, November - December.

" Comprehensive Program Incredses Supervisors' Knowledge of Drug Abuse."

Occupational Fealth and Safety. Vol. 53, No. 10. pp. 48-53.

i Murray, J. B. (1986). Marijuaria's Effects on Human Cognitive Functions, i Psychomotor Functions, and Personailty. The Journal of General Psycholony, 113(1),23-55.

i tielson, P. E., Moffat, A. C., 1980. " Detection and Identification of Amphetamine and Related Stimulants." In: Caldwell, ed. 1980. Amphetamines .

and Related Stimulants: Chemical, Biological, Clinical, and Sociological Aspects." CRC Press, Inc. Boca Raton, Florida.

Neuner, R. P., 1985. Drugs in the Workplace Everyone's Business - Everyone's Problem. Center City: Hazelden.

Peterson, D. J., 1987. "The Ins and Outs of Implementing a Successful Drug q Testing Program." Personnel. Vol. 14, No. 10. pp. 52-55.

Raezer, T. A., 1967, Spring. "Needed Wedpons in the Army's War on Drugs:

Electronic Surveillance and Informants.: 116 Military Law Review 1.

Reed, T. E. (1985). The Myth of the " Average Alcohol Response." Alcohol, 2, 1

515-519.

Shore, H., 1984, Spring. " Employee Assistchce Programs - Reaping the Benefits." Connecticut, Univ. of Sloan F.anagement Review. Vol. 25, No. 3. pp.

69-73.

l 91 Enclosure A

_.--._.- - _ _ - _ - - . . _ _ _ - _ - - _ _ _ . - . _ _ _ _ _ _ _ - - _ . - - _ . _ - . - _ - - - - - _ _ . - - - _ - _ - _ . - _ _ - - - - - - - - . _ . - _ _ . - _ __ _ - - - _ _ - - - _ - _ .___-.3

4 f Stapliton, J. M. , Guthrei,. S. , & Linnoila, M. (1986). Effects of Alcohol and

? >

4 (otherPsychotropicDrugson-Eye. Movement: Relevance to Traffic Safety.

Journal of Studies on Alcohol,'47(5), 426-4S2.

Starr,2A.; Byram, G., 1985, August. " Cost / Benefit Analysis for Employee r Assistance Programs." Personnel Administrator. Vol. 30. No. 8. pp. 55-62.

L

' Tin?s', ' Frank' it. , and ; Sherry liolland, 1984. "A Treatment Evaluation Agenda:

Discussions and Recommendation." NIDA M0liOGRAPH #5.

' Trice, H. M.; Beyer, J. M,- 1984, September. " Work-Related Dutcomes et the Constructive-Confrontation Strategy in a Job-Based Alecholism Program."

= Cornell U., hew York State School of Industrial & Labor Relations Journal of Studies on Alcohol. Vol. 45, No. 5. pp. 393-404.

United States Senate Commission on Commerce,' Science, and Transportation, Washington, DC 20510. 1987, April. Transportation Employee Safety and Rehabilitation Act of 1987. Report Together with Additional and Minority L-Views. Calendar No.- 97; 100-143.-

LWesterman, S. T. , Gilbert, L. M. , & Shrewsbury, N. J. (1981, September). A Non-invasive Method of Qualitative and Quantitative Measurement of Drugs.

The Laryngoscope, 91, 1536-1547.

Westhiemer, G. (1963). Amphetamine, Barbiturates, and Accommodation-convergence.

Archives.of Ophthalmology, 132-138.

Wilkinson, I. M. S. (1986, July). The Influence of Drugs and Alcohol Upon Human Eye' Movenient. -Proceedings of the Royal Society cf isedicine, 69, 479-480.

Willette, R. E., 1986. Drug Testing Programs. In Hawks,- R. L. and Chian'g, C. N.,

Eds., Urine Testing for Drugs of Abuse. NIDA Research Monograph 73, i

i l

I

. 92 Enclosure A

~

+

i IV. CUT 0FF LEVELS Chicng, C. N., Hawks, R. L., 1966. " Implications of Drug Levels in Body Fluids: Basic Concepts." In: Hawks, R. L., Chiang, C. N., 1986. NIDA.

Research Monograph 73. Urine Testing for Drugs of Abuse. Department of Health -

and Human Services.

Clayton,.A. V., 1980. " Effects of'Alcohcl on Driving Skills," Sar.dler, M.,

ealter, The Psychopharmacology of Alcoho,l,, Raven Press, NY.

Cone, E. J., Johnsen, R. E. , Darwin, W. D. , Yousefnejad, D. , Mell, L. B. ,

Paul, B. D. , Mitchell, J. ,1967. " Passive IrNilotion of Marijuana Smoke; Urinalysis at Poom Air Levels of Delta-9-Tetrahydrocannabinol," Journal of _

Analytical Toxicoloy, Vol. 11, No. 3.

COSA, 1986. " Alcohol and the Criver," Journal of the An.erican Medical Association, 1986, 255, Pages 522-527.

Flom, M. C., Browq, B., Adams, A. J., Jones, R. T., 1976. " Alcohol and Marijuana Effects on Ocular Tracking." American Journal Optom. Physic. Opt.., -

53, 764.

Hawks, R. L.; Chiang, C. N., 1966. " Urine Testing For Drugs of Abuse,"

Research Monograph 73, NIDA. Washington, DC: U.S. Govt. Printing Cffice.

Hawks, R. L. (ed.) 1982. "The Analysis of Cannabinoids in Biological Fluids,"

NIDA Research Monograph 42. KhHS Pub No. (ADM)82-1212. Wcshington, DC: U.S.

Govt. Printing Office.

Kogan, M. J.; Razi, J. A.; Pierson, D. J.; W111scr, N. J., 1986, April.

" Confirmation of Syva Enzyme Multiple Intrunoassay Technique (EMIT) d.a.u. arid Roche Abuscreen Radioimmuncassay (RIA) (1251) Urine Cannabinoid Immunoassays by Gas Chromotagraphic/ Mass Spectrometric (GG/MS) and Bcnded-Fhase At' sorption / Thin i Layer Chromatographic (BPA-TLC) Methods." Journal of Forensic Sciences, JFSCA.

Vol. 31, No. 2. pp: 494-500.

- 93 Enclosure A

,o w.

p G iLinnoila, M., Guthrie,JS. , Lister, R., L1986.. " Mechanisms of Drug-Inouced:

F j

-: Impairment of Driving." In:-Drugs'and' Driving. O'Hinion~, J. F., deGier, J. J.,

i p -eds. Taylor & Fran'cis, 1986. . 29-49. Manno,1 J. E. . 1986.: " Specimen Collection 'and Handling'. In: Hawks,'R.~L.. Chicng, C. N., NIDA. Research

, IMonographJ73. EUrine~ Testing for Drugs of Abuse. Lepartment of Health and Human Services.

i LFanno,-J. E., 1986. ~" Interpretation'of Urinalysis Results."

In: Hawks, R. L., 1 I

Chiang, C. N. 1986. NIDA. ~ Research Monograph 73.. Urine Testing For Drugs

' of Abuse. Deparment of Health ano Human Services.

McBurney, L. J.; Bobbie, B. A.;. Sepp, L. A., 1986 "GC/MC an' d Em1t Arelysis'fo'r  ;)

u Analyses' for Delta-9-Tetrahydrocannabinol Metabolites, in - P1asma and Urine 'of

Human Subjects,"~ Journal'of-Analytical Toxicology. Vol. 10. ,

.i Moscowitz, H., 1965. " Skills Performances at Low' Blood Alcohol _ Levels,"

? Journal of Studies-on Alcohol, Volume 46, No.-6, Pages 11-15. ,

.i 1

.0'Hanlon, J. F..LBrookhuis, K.A.,-Louwsrens, J. W., Volkerts, E. R., 1986.

" Performance. Testing as Part of. Drug Registration." In: Drugs and Driving.' l 0'Hanlon,'J. F., deGier, J. J., eds. Taylor & Francis, 19E6. 311-33D.

Peat,'M. A., Finkle, B; S., Deyman, M. E., 1982. In: Hawks, R. L., ed. 1982.

NIDA. Research Monograph.42.- "The Analysis of Cannabinoids in Biological

' Fl uids . " Department of Health and Human Services.

Radlow, R., Hurst, P. M. 1985. " Temporal Relations Between Blood Alcohol Concentration and Alcohol Effect: An Experiment with Human Subjects." ,

'Psychopharmacology. Vol. 85, 260-266.

Ross, L. E. and Ross, S. M., 1985. " Alcohol and Drug Use in_Avietion,"

AlcoholL Health and Research World, Summer,1985, Vol. 9, No. 4, pages 34-41.

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1 1

_ _ _ _ _ _ _ _ _ _ - - - - _ - - _ _ _ - - _ - _ - - - _ - _ - _ - - - _ . _ .- - - - - - -- -- J

y d

LVerebey, K. 1987. _ " Cocaine Abuse Detection by Labcratory Methods." In:.

LWAshton, A. M.,. Gold, M.;S., eds. l1987. ' Cocaine: A Clinician's Handbook.

iGuilford Press'. New York / London.

V. REINSTITUTION'0F UNESCORTED ACCESS f

Babor, Thomas F. , Ned L., Codney, 'and Richard J. Leut.rman. 1986. "The Drug Deper.denc- Syndrome Concept..as an Orcanizing- Principle in the Explanation and

+ Preciction of Relapse." NIDA Research Ponograph- 72.

' Cole, S.. E. Cole, W. Lehman, and W. Jones. 1981. "The Combined Treatment of Drug and~ Alcohol Abusers: '.An Overview." Journal of Drug Issues, 11.

Hubbard,-Robert L...and Mary E. Marsden.. 1986. " Relapse to;Use of Heroin, .

Cocaine, and Other Drugs in the First Year After Treatment." NIDA Research Honograph #72.

NW Jaffe, Jerome H., 1984. " Evaluating Drug Abuse Treatment: -

A Comment on the

- State'of<the Art." NIDA Research Monograph #51.

Maddux,l James'F., and David P. Desmond. 1986. " Relapse anc kecovery in Substance Abuse Careers." NIDA Research Menograph #72.

McClellan, K., 1984. " Work-Based Drug Programs." Journal _of Psychoactive Drugs, 16.

Rounsaville, Bruce J., 1986. " Clinical Implications of Relapse Research."

-NIDA Research Monograph f72.

.Senay,. Edward C., 1964. " Clinical Implications of Drug Abuse Treutment. Outcome Research." ,NIDA Research Moncgraph f51.

E -Simpson,-D., 1984. " National Treatment System Evaluation Based on the Drug Abuse: Reporting Program (DARP) Following Research." NIDA Research Mencgraph

1. 51.

-. 95 Enclosure A

_ ______.__.________-..___________.__.________.___.___m.___ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ . _ _ . _ _ . _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ . . _ . - . . _ _ _ _ _ _ _ . _ _ . _ . _ . _ _ _ _

~

, 's , ,,

• I.

i fSimpson,LD.'and. Kerry Marsh., 1986. "Relepse and Recovery Among 0piods Addicts

--12 Years Atter Treatment." NIDA Research Monograph #72.

Simpson, D., and S. Sell. 1982. " Effectiveness:of Treatment for Drug Abuse: I,

~

An Overview of the DART Research Program." -Advance Studies for Alcohol'and

' Substance Abuse, 2.

Tims,. Frank ~ id. , .and Carl - G. Leukefeld. 1986. "Relepse and Recovery in Drug LAbuse: An Introduction."' NIDA Research Monograph #72. N Vaillant, G. 1983. 'The Naturel History o_f Alcoholism. Harvard University

' Press..

Waldurf D'., and'P. Biernacki. 1981. "The Natural Recovery from Opiate.

3 Addiction." Journal of Druo Issues, 11,

.Wesson, conald R., Barbara E; Havassy, end David E. Smith.1986. " Theories of-Relapse and. Recovery.'and Their Implications for Drug Abuse _ Treatment." NIDA-Research Monograph #72.

Backfit Analysis l I

Because this rulemaking modifies a prior Commission position by adding a j new rule, a. draft backfit analysis has been prepared pursuant to 10 CFR 50.109 in which a preliminary finding is made that the rule will provide a substantial increase in the overall protection of public health and safety and that the direct and. indirect costs of-implementation are justified in view of the increased prr .; tion. As noted, the finding is preliminary and the Commission requests cons.. mts on application of the backfit rule to this rulemaking as g fef :

. presented in t'a draft' analysis. .

I

-Unoer the backfit rule the Commission.has two options with respect to I backfits it' believes are needed. The Commission can make the required finding ofisubstantial incredse in overall protection of public health and safety, or

! it can decide that the rule in question is necessary to provide adequate protection tc the, health and safety of the public and thus not subject to i

. 96 Enclosure A

• h .. ,

'backfit analysis. Although the'. draft backfit analysis adopts the first

!cp' tion, the Commissio' n also desires comment on which'of these two opticr.s is

.the more appropriateifor this ruler.aking. pg The draft.backfit' analysis is available fcr inspection and copying for

a. fee et the NRC Public Document Room et 1717.17 Street, NW, Washington, D.C.

20555. Single: copies may be obtained by writirg to the U.S.: Nuclear Reguldtcry  ;

Commission, Washington, D;C. 20555.

Paperwork' Reduction Act Statement:

This proposed rule arrends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This

' rule has.been:s'ubmitted to'the Office of Management and Budget for review and fapproval.of the' paperwork requirements.

4 Public reporting burden for' this ccliection of'information 1s estimated to average'8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> per response,' including time =for reviewing instructions, j searching existing data ; sources, gathering and traintaining_ the data needea,  ;

and completing and reviewing the collection of information. Send comments [

regarding this burden estimate or any other ospect of this collection of

-information, including suggestions for reducing this burden, to the Records l and Reports Management Branch, Mail Stop P-530, Division of Information Support j

Services, Office of Administration and Resources Management, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555; and to the Office of Information

'and Regulatory Affairs, Office of Manage 0ent and Budget, Washington, D.C. 20503.

Regulatory Analysis An'analysist of the costs and benefits of the proposed rule is . included in the draft backfit analysis described above.

. 97 Enclosure A L______________M.__ . _ _ _ _ _ _ _

Environmental Assessment and Finding of No l Significant Environmental Impact

. Identification of Proposed Action: The proposed rule would require licensees authorized to operate nuclcar power reactors to implement a fitness-for-duty program whose general objectise is to provide reasonable assurance that dCtiVities assCciated with nuclear pobe.r plant operations are carried cut in an environment which'.is: free of the effects ot drugs. .Under the_ proposed rule,

~

testing _ tor impermissible drug use would be conducteo prior to authoririsig-unescorted access to protectec areas.or assignment to other activities within the scope of the proposed rule, randomly for such licensee and ccntractor personnel, after certain operational events, based on reasonable cause, and to verity continued' abstention. in addition, the proposed rule provides for other basic fitness-for_-duty prcgram elurents such as the development of written policy and procedures, provisions for the training of supervisors and

- employees, standards for drug testing, management actions, and requirwents for employee assistence programs and appeal procecures.

'The Need for the Prcposed Action: The Nuclear Pegulatory Commission recognizes

- drug abuse problems to be a social *, medical, and safety problem affecting every segment of our society. Given the pervasiveness of the problem, prudence indicates that the Commission consider measures that would continue to ,

reasonably assure that the effects of drugs do not adversely effect the public health anc safety.

The Commission recognizes and appreciates the significant ef forts already undertaken by the Nuclear Utility Management end Resources Council (NUMARC),

the Institute.of Nuclear Power Operations (INPO), and the Edison Electric Institute (EEI), and each nuclear power reactor licensee in developing and implementing fitness-for-duty progrems for nuclear power plcut personnel.

. Nevertheless, the Commission's- evaluation of experience gained since its policy statement was published in the Federal Register on August 4, 1986, indicates that rulemaking is now appropriate to achieve further improvements.

. 98 Enclosure A 9

- _ _.______.____.__._____._____.___m. _____._.____.________.__._..__.____1. _ _ _ _ _ _ _ _ . _ _ _ . _ - . _ . _ _ - _ . _ . _ _ _ . _ _ . _ _ _ _ _ _ . _ _ . _ _ _ _ _ _ _ _ _ _ . _ _ _ . . _ _ _ _ _ _ _ . . _ _ . _ _ _ _ _ . _ _ . _ _ . . _ .

E

~

i l Environmental Impacts of the Proposed Action: The proposed rule would require certain managerent. actions and procedurt.s intended to minimize the probability of human error-that could endanger the public health and safety. Althouch these activities would have a social and economic impact, the impact on the environment would be positive in that there would be some reduction in the probability of a radioactive release due to human error by a person impaired from the effects of drugs.

Alternatives tc the Proposed Action: The principal alternative would be to take no acticn and continue to use the Commission's policy stctement of August 4, 1986 (51 FR 27921). Since the Connission has concluoed that no adverse environmental effects are associated with this proposed action, any alternatives with equal or greater environmental impact net.d not be evalt.atea.

A Alternative Use of Resources: This action involves the use of health care professionals ano facilities not previously considered in cor.nection with the Final Environmental Statements related to any licensed facilities.

Agencies and Persons Consulted: The NRC staff considered numerous documents which are listed in the above bibliography, and has me.t with representatives from NUMARC and fcur unions (The International Brotherhood of Fitctrical Workers, the International Union of Operational Engineers, the 011, Chemicci and Atomic Workers Union, and the Building and Construction Trades Departnent of the AFL-CIO), the Federal Aviaticn Administration, the National Institute on Drug Abuse, and Battelle Human Affairs Research Center.

Findings of No Significant Impact: The Commission has determined under the National Environmental Policy Act of 1969, as amenced, and the Comnission's regulations in Subpart A of 10 CFR Part 51, that this rule, if cdopted, would not be a majcr Federal action significantly affecting the quality of the human environment and therefore er environmental impact statement is not requiri.d. '

99 Enclosure A l

1 J

i ..

Regulatory Flexibility Act. Certification

In accorcance with the- Regulatcry Flexibility Act' of 1980, 5 U.S.C.

605(b), the Commission hereby certifies that this rule will.not have a significant economic-impact on a substantial-number of small entities. The proposed new 10 CFR Part 26 applies to certain owners and operators of civilian

' nuclear power-reactors cria their. contractors. The companies that own these facilities do not fell within the scope of "small entities" set forth in the-Regulatory Flexibility Act or the small business size standards set out in regulations issued by.the Small Business Administration in 13 CFR Part 121.

Any costs to the minor number of small entities affected, i.e., contractors, will apply only to those centractor employees working at the ruclear power reactors, and would probably'be reimbursed through the contract.

List of Subjects in 10 CFR Part 26 Fitness for duty, Chemical testing, Drug abuse, Drug; testing, Eirployee Assistance Programs, Management actions, Sanctions, Appeals, Protection of information, . Reporting and Recordkeeping requirements, Nuclear power reacter s.

For the reasons set out on the preamble and 'under the authority of' the Atomic Er;ergy Act of 1954, as amended, the Energy Reorganization Act of 1974, .,

as dmended, and 5 U.S.C 553, the NRC is proposing to adopt o new 10 CFR Part 26.

1. Part 26 is acced to 10 CFR Chapter I to read as follows:

Part 26 -- Fitness for Duty Programs General Provisior.s Sec.

2,6.1 Purpose.

26.2 Scope. .

.26.3 Definitions.

. 100 Enclosure A

h .

26;4 Interpretations.

26.6- Exemptions.

26.7 Information collection requirenwnts: OMB approval.

General Performance Objectives 26.10 General performance objectives Progrsm Elements and Procedures 26.20 Written policy ano procedures.

26.21 Policy communication ar.d awareness trcining.

26.22 Training of~ supervisors and escorts.

26.23 Contractors.

26.24 Chemical testing.

26.25 -Employee Assistence Programs (EAP) 26.27 t'anagement cctions ar.d sanctions to be imposed.

26.28 Appeals.. ,

26.29 Protection of information.

Inspections, Reccros and Reports 26.70 Inspections.

26.71 Recordkeeping requirements.

'26.73 Reporting requirements.

Audits 26.80 Auaits.

Enforcement 26.90 Violations.

Authority: Secs. 53, 81, 103, 104, 107, 161, 68 Stat. 930,

. 101 Enclosure A

=_______-- _ - _ _ - _ _ _ _

935, 936, 937, 939, 948, as amended (42 U.S.C. 2073, 2111, 2112, 2133, 2134;2137,2201); secs.201,202,206, SS Stat. 1242, 1244, 1246, as amended (42 U.S.C. 5841, 5842, 5846).

For the purposes of sec. 223, 68 Stat. 958, as amended b. U.S.C. 2273) 99 26.20, 26.21, 26.22, 26.23, 26.24, 26.25, 26.27, 26.28, 26.29 and 26.80 are issued under secs.161b er.d i. 68 Stat. 948, and 949 as amended [42 U.S.C. 2201(b) and (i)];St 26.70, 26.71, and 26,73 are issued under sec. 1610, 68 Stat. 950, es amended [42 U.S.C.'2201(o)].

General Provisiens 5 26.1 Purpose.

This par'. Ooscribes requirerr.ents and standards for the establishrrent and maintenance of certain aspects of fitness-for-duty prcgrams and procedures ty the Dcensed nuclear industry.

9 26.2 Scope.. ,

(a) The regulatici.s in this part apply to licensees authorized tc cperate a nuclear power reactor. Ecch licensee shall implement a titress-for-dety program which complies with all sections of this part. The previsions of the titt.ess-for-duty program reust apply to all per, sors granted utescorted access to protected areas, at:0 to licensee or contractor personnel required to respond to a licensee's Technical Support Center (TSC) er Emergency Operations Fi.cility (EOP) in accordance with licensee emergency plans and procedures. The regulations in this port do not apply to NRC representatives, law enforcemer.t personnel, and offsite emergency fire and medical response personnel while on officici duty.

(b) The requiremer.ts in this part must be irr.plemented by each licensee duthorized to operate a nuclear pCwer redCtCr no later than (insert cate 90 days after publication of final rule), except for the requirements to implerrent random drug testing contained in s 26.24, which must be irrplementea no later than (insert date 180 days atter publication of final rule).

- 102 Enclosure A

5 26.3 . Definitions.

" Aliquot" means a porticr. of a specimen used for testing.

" Commission" means the Nuclear Regulatory Commission or its duly authorized representatives.

" Confirmatory test" means'a second analytical procedure to ioentify the presence of a specific drug or metabolite which is independent of the initial test.anc which uses a different technique and chemical principle from that of the initial test.in order to ensure reliability and accuracy.

" Confirmed pusitive test" meer.s the result of a confirmatory test has confirmed the presence cf concentrations at drugs or metabolites in 6 specimen 6bove the " cutoff level."

" Cutoff level" means the value set for designating a test result as positin .

" Drug abuse" meer s the use of a psychoactive substance for other than medical purposes which impairs the physical, mental, emotional or social well-being of the user.

" Follow-up testing" means chemical it. sting at unannounced intervals, during or as follcw-up to treatment, to ensure that an employee is maintaining abstinence from the previously identified abuse of drugs.

"For-cause testing" means chemical testing at the request of a supervisor, or other responsible mar,agement official, based upon reasonable suspicion that a person is impaired or may have used drugs.

" Illegal' drugs" means a controlleo substs... 1 includec in Schedule I or II of the Centrolled Substances Act, as amended, 21 USC 801, et seq. The term

" illegal drugs" does not mean the use of a controlled substance pursuant to a valid prescription or other uses authorized by law.

" Impairment" means deficient or diminishing on-the-job performance resulting frcm physical or psychological stressors, that mcy include abuse of drugs or other substances.

" Initial screening test" meens an immunossay screen to eliminate "r.egative" urine specimens from further consideration. -

" Protected area" has the same meaning as in Sectico 73.2(g) of this chapter, an area encurpassed by physical barriers and to which access is controlled.

103 Enclosure A 1

e

" Random-test" means 6-system of unannounced orug. testing imposed in a

statistically random manner to o group so that all' persons within th6t group have an ecunlL probability of selection. .

" Suitable inquiry" means verification of employment history for a minimt.m of the past five years, obtained tnrough contacts'with previous employers to determine if a' person was, in the past, tested positive for illegal drugs,

• subject to'a plan for treating drug. abuse, removed from, or made ineligible for .# 7. .

i activities within the scope of 10'CFR 26, or denied unescorted' access at any- i other nuclear f, ewer plant or other employment in accordance_ with. a-fitness-for-duty policy.

" Unannounced testing" means unannounced random tests.

6.26.4, Interpretations.

Except as specifically authorized by the Conmiss1cn in writing, r.o interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the Ger:eral Counsel will be recognized to be binding upon the Commission.

$ 26.6 Exemptions.

The' Commission may, upon application of any interested person or upcn its own initiative, grant such exemptics.s from the requirements of the regulations

?- in this part as it determines are authorized by law and will not endanger life er property or the common defense and security and are otherwise in the public interest.

5 26.7 Information Collection Requirements: OMB Approval.

(a) The Nuclear Regulatory Commission has submitted the information

! .cullection 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 ccntrol r. umber _.

(b) The approved Information collection requirements containea in this part appear in 55.26.20, 26.21, 26.22, 26.23, 26.29, 26.71, 26.73, and 26.80.

l l

i

. 104 Enclosure A' L___--_ _

o General Performance Objectives 5 26.10 General Performance Objectives.

. Fitness-for-duty programs shall:

(a) Provide reasonable assurance that nuclear pcwer plant personnel are

-not under the influence of cny substance, legal or illegal, or mer. tally or physically impairec t' rom any cause, which in any way adversely aff(cts their ability to safely and competently perforn, their dutiest (b) Provide reasonable meastres for the earlv detection of persons who are not fit to perform activities within the scope of this port; and (c) Have a goal of ochieving a drug-tree workplace and a werkplace f ree of ~

.the effects of such substances.

Program Elements and Precedures G 26.20 Written Policy ai;d Procedures.

Each licensee subject to this part shall establish and implement written.

pol.icies and procedures designeo to meet the general performance objectives.ano ,

specific requirements of this part. Each licensee shall retain a-copy of the current written policy ano procedures as a record until the Commission g terminates each license for which the policy and procecures were developed cno, if.any portion of the policies and procedures are superseded, retain the superseded material tor three years after each change. As a minimum, written policies and procedures shall address fitness for duty through the following:

(a) An overall description cf licensee policy on fitness for duty. The policy shall address abuse of illegal drugs and legal drugs (e.g., alcohol, prescription and over-the-counter drugs). Licensee policy shall also address #/

.other factors that could affect fitness for duty such as mental stress, fatigue and illness. Written policy documents shall be in sufficient detail to provide offected individuals with information on what is expected' of them, and what consequences may result from lack of adherence to the policy. .

(b) A description of prcgrams which are available to perscr.nel desiring assistance in dealing with drug or other problems that could adversely c.1tect

the performance of ectivities within the scope of this part.

(c) Procedures to be utilizeo in testing for drugs, including procedures for protecting the employee and the integrity of the specimen, and the quainy

- 105 Enclosure A I

l::

!:  : controls used to ensure the test results=ar'e valid and attributable to the  !

cotrect individual.-

'(d) AJoescription of immediate and follow-on. actions which will be-taken,-

Land the procedures to'_be utilized, in those cases where employees or

contractors assigned to dutfes within the scope of this part are determined to -)

ihave been invoiced in the use,. sale, or possessicn of illeaal drugs.

I

- @ 26.21. Policy Communications and Awareness Training.--

(a)'Persens assigned to activities within the scope or this part shall be

.prcvided with' appropriate training to cusure they understand --

(1) Licensee policy and procecures, including the methods that will be used to implement the policy;-

(2) The personal and public health and safety hazards associatt.o with i i

abuse of-drugs;  ;

(3) The effect of prescription and over-the-cour.ter drugs and dietary  !

l conditions on drug test results, and the role of the Medical Revicw Officer;  ;

-(4) Employee-assistence programs provided by the licensee: a n d. - j (5) What is expecteo of them and what consequences may result from lack cf j adherence to the policy,  !

(b) Initial-training must be completed prior to assignment to activities- l within the scope of this pert. Refresher training must-be completed on an .l annual basis, or more frequeritly where the neco is indicated. A record of the -l training shall be retcined for a period of at least three years.

5 E6.22- Training of Supervisors and Escorts. l (a) Managers and supervisors.of activities within the scope of this pcrt l shall be provided appropriate training to ensure they understand -- ,

.(1) Their role and responsibilities in implementing the program- l (2) The rcles and responsibilities of others, such as the personnel, l

' medical, and Employce Assistance Program (EAP)' staffs; j

.(3) Techniques for recognizing crugs, indications of the use, sale, or ,

possession of drugs; (4) Behavioral observation techniques for detecting degradation in performance, impairment, or changes in employee behavior (in the cese of i

. 106 Enclosure A

L #

j *

~

escorts, the beh'vioral a observation techniques shall cover detection of

' impairment);and (5) Procedures' fo'r initieting appropriate corrective actien, to include referral:of employees for-counseling or treatment (in tne case of esccrts, this shall cover reporting'to appropriate management).

(b) Perscos assigned escort duties shall be provided appropriate training to ensure they urc'er stand the matters cor.talried in {26.22(a)(3), (4), ard (5).

(c) Inittel training must be coa.pleted within 3 raonths of initial supervisory essignment, or prior to essignment of escort duties. Refresher training must be ccopleted on an annual basis, or more frequently where the necd is indicated. A record of the training shall be retained for a period of at least three years.

5 2C.23 Contractors.

All contractor personnel performing activities within the scope of this port for a licensee must be subject to either the licensee's program relatir.g to drug abuse, or te a program, formally reviewed and approved by the licensee, which meets the standards of this part. Written agreements between licensees and cont.ractors for activities within the scope of this part shall be retained for the life of the contract ano will clearly show that --

(a) The contractor is responsible to the licensee for adhering to the licensee's fitness-for-duty policy, or maintaining and adhering to an effective fitness-for-duty program which meets the standards ci this part; and (b) Personnel having been denied access or removed from nuclear safety activities at any nuclear power plant for violations of a fitness-for-duty policy will not be assigned to contracted work without the knowleage end ccnsent of the licensee.

L 26.24 Chemical Testing.

(a) To provide a means to deter and detect drug eLuse, the licensee shall implement the following chemical testing progrums for persons subject to this part:

(1) Testing immediately before the initial granting ci unescorted access tc protected areas or essignment to activities within the scope of this pcrt.

1

l 107 Enclosure A

n (2) Unannounced tests imposed in a random manner. The tests must be administered so that a person completing d test is immediately eligible for enother unannounced test. The tests rnost be cor.tucted in a marr.er that ast.ures thdt at it.est 90 percent of the individuals within the scope of the rule are tested each year, that testing is performed throughcut the year and that N3 l testino rates for individuals already tested with negative results not be lower I than 30 percent per year (21/2 percent per month) for the remair,c'er of the .

testing year.

(3) Testing for-cause, i.e., immediately tollowing any observec behovior indicating possible drug abuse; after accidents involving c failure in individual performance resulting in personal injury, in c radietion exposure or release of radioactivity in excess of regulatory limits, or actual or potential substantial Cc9radations cf the level of safety cf the plant; er af ter receiving credible information that an individual is ebusing drugs.

(4) Follow-up testing on a random basis to verify continued abstu. tion from the use of drugs.

(b) Testing for drugs shall, at a minimum, centorm to the "Mandatery Guidelines for Federal Workplace Drug Testing Programs" issued by the Alcohol.

Drug Abuse, eno hental Health Administration of the Departnent of Health and Human Services (53 FR 11970), hereindfrer referred to as the HHS Guic'elines.

Licensees, at their discretion, may implement programs with trore stringent stancards (e.g., lower cutoff levels). Management actions with respect to persons who fail a more stringent standaro, but do not test positive under the HHS Guidelines incorporated in this rule, wculd also be at the discretion of the licensee.

(c) Licensees shall test for all five crugs or classes of drugs described in paragraph 2.1(a)(1) and (2) of the HHS Guidelines. In addition, licensees shall consult with local law enforcement authorities ano crug counseling services to determine whether other drugs are being used in the geographical locale of the facility and the local workforce. Where appropriate, other drugs so identifiec must be added to the list of drugs being tested. Conservative cutoff 11 nits must be establishto by the licensee for these crugs.

(d) Licensees may conduct preliminary tests of an oliquot prior to forwarding selecteo specimens to a contract laboratory meeting the requirements of paragraph (e) of this section, provided the licensee's staff possesses the l

. 108 Enclosure A L - - -_____-___- - - _ _ _ _ _ _ _ _ - . _ _ _ _ - - _ - _ _ _ _ _ _ _ - - _ - _ - _ _ _ _ - _ _ __ __ _ __ _ _ _ _ _ _ _ _ _ _ _ _ . _ ___ _ _ - . _ _ _ _ _ _ _ _ -

5 necessary training ano skills- for the tasks assigned, their qualifications are

-'uocumented, and adequcte quality controls erii. implemented. Quality control

- procedures for preliminary tests- shall include' the processing of blind perfer-mance tt.st specimens and the submission to the contrect labora' tory of a sampling of specimens initially tested as negative.

(e) Quality controls anc procedures for contract laboratories shall be consistent with the HHS standards' for " Certification of Laboratories Engaged in Urine Drug. Testing for Federal Ager,cies." (53 FR 11970, 11906 - 11989).

Contract laboratories shall conduct initial screenina tests and confirmatory tests on all specimens forwarded for testing. Licensees shall submit blino performance test specimend to contract laboratories in accordance with paragraph 2.5(d)(2) 'and (3) of the HHS Guidelines.

5 26,25 Employee Assistance Frcgrams (EAP).

Each licensee subject to this part shall maintain an Employee Assistance Program to strengthen fitness-for-duty programs by offering essessment, short-term counseling, referral services, and treatment monitorino to employces with problems that could adversely affect the performance of activities within the scope of this part. EAPs should be oesigned to achieve early intervention dGd provide for confidential assistance (eXCept where safety considerations mustprevail). EAP staff shall inform licensee management when a. determination has been made that a self-referring individual's condition constitutes a hazard to himself or herself or others.

-@ 26.27 Management Actions and Sanctions to be Imposed.

(a) Prior to the initial granting of unescorted access to a protected area or the assignment to 6ctiv; ties within the scope of this part to any person, the licensee shall obtain a written statement from the individual as to whetner j activities within the scope of this part were ever denieo the individual and shall complete a' suitable inquiry to oetermine if that person was, in the past, tested positive for illegal drugs, subject to a p.lan for treating drug 6buse, 47 f L

or removed from activities within the scope of this part, or denied unescorted access at any other nuclear power plant in accordance with a titress-for-duty policy. If such a record is established, the new assignment to activities within the scope of this part or granting of unescorted access must be based 109 Enclosure A

(

o- _ _ ._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .

1: ,

upon a management and medical determination of fitness for duty and the

-establishment.cf an appropriate follew-up testing program, providea the- .

restrictions of paragraph (b) cf this section is observed. To meet this requirement, the identity of perscns denied urescort'eo access or removed under the' provisions of this part and the circumstances for such deniali or^ removal, including test results, will be made available in: response to cn inquiry by any 4[

company or'its.contcuctor falline under the scope of this part. Failure to list all previous:empicyers anc reasons for removal or revccation of unescorted

. access. shall~ be cause for denial. of unescorted access..

(b) Each licensee subject to this part'shall, as a minimum, take the following actions. Nothing herein shall prohibit the licensee from taking more stringent action.

(1) A confirmed positive test result, lacking any other evidence to the centrary, shall be presumed to be an indication of effsite drug use. The first confirmed positive test shall, as a minimum, result in immediate. removal from ectivities within the scope of this part for at leest 14 days pnd referral to the EAP for essessment and.counselir g during any suspensicn period. Plans'for treatment, follow-up, and future employment, shall be developed, and'eny g rehabilitation program deemed appropriate must be initiated as appropriate, during such suspension period.. Satisf actory management and medical assurance of the individual's fitness to adequately perform activities within the scope of this part shall be obtained before permitting the incividual to be returneo to these activities. Any subsequent confirmed positive test shall result in removal from unescorted access to protected areas and activities within the scope of. this part for a minimum of three years from the date of removal.

(2) Any individual determined to have been involved in the sale, use, or possession of illegal drugs while within a protected area of any nuclear power plant shall be removed *om activities within the scope of this.Part. The individual may not be 9 nted unescorted access to protected areas cr assigned to activities within the scope of this part for a minimum of five years from the date of removal.

(3) Persons removed for periods of three years or more under the provisions of the above paragraphs for the illegal sale, use or possession of drugs and who would have been removed under the current standarcs of a hiring licensee, may be granted unescorted access and assigned duties within the scope

. 110 Enclosure A

m _ ___ _ _ _ _ _ __ _ _ _ _ -

i

r. i f

of this part by a licensee subject to this Part only when the hiring licensee ll receives satisfactory medical assurdrice that the person has obstained from ,

drugs for at least three yeers. Satisfactory maragement and tredical assurance l cf the individual's' fitness to adequately perfctm activities within the scope df.5 of_this part shall be obtained before permitting the individual-to perform activities within the scope of this part. Any person granted unescorted access or whose access is reinstated urider these provisions, shall be given  ;

unannounced follow-up tests. ct lebst once every three n.onths for three years  !

]

dfter reemployment .to Verify Continued abstinence f rcm drugs. Any ConfirmeC ]

use of drugs through this' prccess or any other determination cf subsequent

' involvement in the sale, use or possessicn of illegal drugs shall result in Ab permanent cenial of unescorted eccess. *l (c) Refusal to prcvide a specimen for testing and resignation prior to remcval for violation of company poiicy concerning drugs shull be recordec as e 4, 7 ; ,

removal for cause. Such records chall be retained for the purpose of meeting f' the requirements of 6 ?6.27(a).

(d)' If a' licensee has reasonable belief that an NRC employee may be uncer the influence of any substance, or otherwise unfit for duty, the licensee may not deny access but may escort the indivioual. In any instance of this occurrence, the appropriate Regional Administrator shall be notified immediately by telephone. During other than normal working hcurs, the tmC

- Operations Center shall be riotified.

6 26.28 Appeals.

Each licensee sub,iect to this part shall establish e procedure for employees and contractor / vendor en4ployees to appeal fitness for duty determinations that could have an ocverse effect on the individual's employment. The procedure must prc W e notice and an opportunity to respond and be consonant with fundamental principles of due process. Where appilcalle, grievance review procedures contained in collective bargaining agreements covering the bargainirig unit of which the employee is a member will nonrally meet this requirement, and they may be used for this purpose whether or not the ecministrative action teken is a grievable action under the contract.

1 111 Enclosure A L___ _______-m_. _ . _ _ . _ _ _ _ _ . . _ _ . _ _ _ _ . _ _ _ _ _ _ _ _ - _ _ . . _ _ _ . _ . . _ _ . _ _ _ _ _ . _ _ _ _ _ _ _ _ _ . _ _ - _ . _ - . _ _ . . _ _ _ _ _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ . _ _ _ . _ _ . . _ _ _ _ _ _ - . - _ _ _ _ _ _ _ - _ . . _ _ _ _ _______________.__.__a

4

- l'26.29 Protection of Information.

(4). Each licensee ' subject:to this part, who ecliects perscnal infcrn.ation L' L on an' employee for the purpose of complying with this part, skll estchlish and

. traintain n system of. files and procedures for the protection of the pcrsonal

- information. Such system shall be maintained until the. Commission terminates OM6 i e each license for which the system was developed.

. (b) The licensee shall not disclose the perscr.El information collected end maintained to persons-other than assigneo . medical. review. officials, other -

licensees legitin6tely seeking the information as required'by this' part for.

empicyment decisions and who have obtained a. release from current or

. prospective employees or contractor perscnnel, NkC representatives, appropriate-law enforcement officials, the subject incividual or his or. her representative, or to those licensee perscnnel whc h6ve a need to have eccess to the information in performing assignec cuties. ,

Inspections, Records, and Reports 6 26.70 Inspections.

(a) Each licensee subject to this part shall permit duly authorized representatives of the Con. mission to inspect its records, premises, activities,.

and personnel as may be necessary to accomplish the purposes of this part.

(b) . Written agreements between licensees and their contractors will cleerly show that the --  ;

(1) Licensee is responsible to the Commission for maintaining an l effective fitness-for-duty program in accordance with this part; and ]

(2) NRC may inspect, copy, or take away copies of any licensee or i contractor documents, records, and reports related to implementation of the l licensee's or contractor's fitness-for-duty program under the scope of the contracted activities.

112 Enclosure A

_____.._.____.____m___.__.__.__..__._______m_ _ . _ _ _ _ _ _ _ . -

x .

is 26.71- Recordkeeping Requirements.

Each licensee subject- to this part shall' --

'(a). Retain records of inquiries conducted in accordance with ? 26.27(a),

L 'that result in the granting of unescorted access to protected areas, until' three years following termination of such access authorizations; (b) Retain' records of confirrred positive test results which are concurred in by. the Medical Review Officer, and the subsequent personnel actions for a period of at least three years; and (c) Retain records of persons mace ineligible for three years.or longer for assignment to activities within the scope of this part under the provisions of 5 26.27(b)(1), (2).- (3)' or (c), until the Cctr; mission terminates each license under which the recoros were created. ,

(d) Collect and compile fitness-for-duty program perforrrance data' ac described in NRC Form . The data shall be arilyzed and appropriate k$ I actions taken to correct program weaknesses. Such data and analysis shall be retained for three years and made available for inspection by the' NRC.  !

s 26.73 Reporting Requirements.

(a)(1) Each licensee subject to this part shall inforrr the Comission of significant fitness-for-duty events including:

(i)' sale, use, or possession of illegal drugs within the protected area and, (ii) any acts involving the illegal sale, use or possession of a controlled' substance by any person licensed under 10 CFR Part 55 to operate a M l}

power reactor or by any supervisory personnel assigned to perform duties within the scope of this part. This includes the results of confirmed positive tests on such persons.

(2) Such notifications shall be made to the hRC 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 event.

(3) Written reports documenting such notifications and specitying actions taken shall be submitted within 30 days to the U.S. Nuclear Regulatory Comission, Document Control Desk, Washington, D.C. 20555. The licensee shall ,

also submit one copy to the appropriate NRC Regional Office. Written reports {

shall not inchide the names of the individuals.

113 Enclosure A 1

, J

(b) Fitness-for-duty events shall be reported under this section rather than reported uncer the provisions of $73.71.

Audits L .

l 9~26.80 Audits.

(a) Each licensee subject to this part shall cause the fitness-for-duty prcgram to be audited at least once every 13 months. In additien, eudits sFall be conducteo, at least once every 13 n.onths, of those portions of fitness-tur-duty programs implemented by contractors. Licensees may accept audits of contractors conducted by other licensees and nee 6 not re-audit the same contractor for the same period of time. A copy of the audit report, to incluoe findings, recommendations and corrective action must be providec to y /9-each sharirig utility and made available on site for NRC inspection. Licensees retain responsibility for the effectiveness of contractor programs and the implementation of appropriate corrective action.

(b) Audits shall' focus on the effectiveness of the program and be conducted by individuals cualified in the subject (s) being aucited, and independent of both program management and personnel directly responsible for implen,entation' of the fitness-for-duty program.

(c) The result of the audit, along wit.h recommendations, if any, shall be documented and reported to senior corporate and site management. The j resolution of the audit findings and corrective actions shall be cocumented. '

s These documents shall be retained for three years and made available for NRC ,

inspection. l Enforcement l l

5 26.90 Vi olati or.s . ,

(a) An-injunction or other court order nay be obtained to prohibit a l violation of any provision of --

(1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974; or (3) Any regulation er order issued under these Acts. l 114 Enclosure A

(b) A court order may be obtained for the payment of a civfl' penalty imposed under 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 i Act;.

(2) Section 206 of the Energy Reorganization Act of 1974; 7(3)l Any rule,' regulation, or or6er issued under these Sections, or under Section 161 of the Act;- i

_ (A) - Any term, concition, or limitation 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.

(c) Ary person who willfully violates any provision of the Atomic Energy

' Act of 1954, as amended, or any, regulation or order-issued under the i requirements of the Act, include. regulations under this part, may be guilty of a crime and, upon conviction, may be punished by fine or imprisonment or both, as.provided by law.

l 1

I Date at Rockville, MD this day of .-1988. ,

FOR.THE NUCLEAR REGULATORY COMMISSION.

I i

Samuel J. Chilk I i

Secretary of the Commission. 2 i

1 1.

115 Enclosure A 4

O

+

Appendix to the_ Document Fitness-for-Duty Prcgram Elements Not Included in the Proposed 10 CFR Part 26 The Ccmmission has decideo net to include several m6tters in the propeted fitness-for-duty rule, but seeks comments as to whether these matters should be added to the rule or included as recommendations-in implementing guidance.

1. Expand the scope of the rule to include other activities directly relatec to nuclear safety by licensee and contractor personnel. This coulc include engineering and quality assurance activities performed outside 6 protected area and activities performed by escorteo licensee or ccrtrSctor personnel within a protected area which, if not properly perfern.eo, could contribute to facility conditions adverse to public or worker safety.

2. Require that licensees take specific measures to deter onsite sale,

• possession, or use of alcchol anc drugs and to achieve early detection should these problems exist. These measures could include:

(a) searches of the workplace, which woulo be unannounced and random, (b) investigations designed to determine whether there is an existing cr potential problem, s

(c) a mechenism for discreet expressions . 7 concern regarding the condition of an employees' fitness for dutyNdk a manner that can facilitate unrestricted flow of information, and 1

(d) inforniation collection from law enforcement authorities and drug I l- counseling services concerning drug activity in the local community.

l I

l 1

116 Enclosure A l

1- _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _

s .(J I, '(i .r

e. _

A (3h. . The hRC developed a list of cata- that appear; to be appropriate based upon

- inforrredireviews by. appropriate professionals:in other organizations. To ensure consistency,of: data and.to ft.cilitate analysis, the craft form-

. below 'could be utilizoc'.. - The Cornmission' seeks specific connentsJa s tc '

whether theldata listed form ci rclevant. basis for the evaluation of .j .

program' performance, and whether there are any'other data'.which would be .:f[f importar.tLin~ this . regard. .

s l-

. 117 Enclosure A

__ _____m__-..____.________m_.__.__ .- _. -

FITNESS-FCR-DUTY PROGRN4 PERFORMANCE DATA Site: Period: Jan-Jun 19 -

Jul-Dec 19

-Centact Name: Docket #'s Telephone Nurter: ( ) _.

Avg # of Employees:

-Avg.# of'" Permanent" Contractor Employees: __ _

(Contractor cnsite 6 n.onths or longer)

Avg # of Other Contractors: _

I. -

TESTING Employees Contractors Action Taken:

( # POS) ( # POS) Term Rehab Pend A. Reemployment /Prebadging. ( ) ( )

B. Unannounced Periodic ( ) ( l ,,

C. Unannounced Random ( _) ( ) ,__

D. For Cause (Incl Post-Accident) ( ) ( ,_]

E. Followup (Verify Abstention) ( ) ( )

F. Other (Describe: ) ( ) ( )

G. Drugs Identified (#):

Ndrijuana Amphetamines 0pictes Others Coccine ,

Phercyclidine Alcohol (Describe)

II. PROACTIVE EFFORTS Total # Subjects Action Taken:

1 Man-Hrs ID'd Term Rehab Pend A. Searches of Workplace ~~

B.~ Searches of Personal Vehicles ~~

C. Searches Using Dog ~ -~

D. Investigations by Licensee / Contractor -

E. Investigations / Arrests by Law Enforcement XX F. # ID'd by Supervisor H XX G. # ID'd thru Allegs. to Employer H -

XX F. ( ID'd thru Allegs. to others (NRC, Law Enforcement, etc.) XX XX I. Other (Describe: ) X_X XX l

Data should reflect only those persons confirmed to be using, possessing, or l salling.arugs. " Term" means terminated, "Rehab" means rehabilitated (or counseled) and returned to duty, " Pend" n'eans final disposition is pending.

IV. EAPPROGRAMUSE(REFERRALSOURCCj Disrcsition Dropped Employees Contractors Rehab Program Term. Pend A. . Self B. Family C. Friends /Coworkern _ _ _ _

D. Union E. Supervisors _

F. Other(Describe: _]

V. CAUSEOFBEHAVIOFALPROBLEll(REASONFORREFERRAll Employees Contractors A. Mental / Emotional _

B. Family / Relationship C. Jub Related D. Medical E. Legal ___ _

F. Financial G. Alcohol H. Drugs _ _ _

I. Other(Describe: )

VI.

SUMMARY

DESCRIPTION OF LESSONS LEARNED:

Briefly cescribe any program changes since last report; include additicnal drugs tested per 10 CFR 26.24(c)(2)(iv); describe any cutoff levels lower than in HHS Guidelines.

+

4

____m_m_ _ _ - _ _ _ _ _

I _

0-7 DRAFT BA.CKFIT ANALYSIS FITNESSF0P.-DE

-Ittm 1: . Statement:af the. specific objective that the prcpcsed backfit is designed to' achieve; hesponse:e o .The objective of the fitness-for-duty rule is to'significu.tly.

increase the assur6nce of public health-'and safety by. removing personnel,who are judged'to be unfit 'for duty from unescorted access to protected areus at . nuclear power plants and prohibiting assignment of. duties within the scope of the rule. Personnel wh'o'would be

. considered unfit for duty would be those who use illegal drugs, improperly use alcohol or prescription. drugs, or have physic 67 cr mental stress or impairments that (.culd leao tc en unsafe situation.-

. Licensees of nuclear power plants would be required to develop programs to address all of these fitness aspects. However, specific.

. implementing provisions are stipulated only in the area of use of illegal drugs.

e 1

L-____--_____

43

' Item'2: ~ General description oflthe activity that would be-required of'the licensee or: applicant in order to complete the backfit;

[ Response: The-proposed rule would'requireLlicensees authorized to operate a nuclear power reactor. under 10 CFR 50.22 to implement and maintain 4-fitness-for-duty program. - This proposed rule diso requires that contractor personnel be covered by a ' fitness-for-duty program.

.The proposeo rule specifies that inaustry, implement the folleving requirements:

~

(a) Development of written policy and procedures, includino management actions in response to drug abuse Each licensee is required t' dratt policies and procedures for implementing and maintaining a fitness-for-duty program. These documents shall denote all standards of concuct, physical state and mental state expected of employees and contractors, ano all requirements for management action.

Since all affected licensees currently have fitness-for-duty policies and procedures in-place, the staff finds that the proposed rule will necessitate only minor revision of these documents in order to conform to the requirements of the new rule.

-(b) Awareness training program... transfer of policy ano procedures to all employees All licensee perscnnel and contractors (workers and supervisors) involved in the nuclear portion of the utility's business must participate in an awareness training program that explains the new policies and procedures underlying the fitness-for-duty program. Although awareness training is already an integral part of fitness-for-duty progr6ms, the staff assumes that the 2

. ;\

formulation' of. new policies: and. procedures' will\ recuirelall-

~

-; employees to attendian additional orientation program.

'j (c) RefresherE t raining for all employees'(at least'ence a year) .  !

All.licenseepersonnelandcontractors(wcrkersandsupervisors)'

subject to the provisions of- the fitness-for-duty program will'

~

be 'rcquired to ecmpleteL refresher training at least encc' every year. :This trainir,9 essentially covers all Lspects of the program and includes discussions on'the health and safety hazards associated with the abuse of drugs.

(d) Development of written agreements between licensees and their contractors and vendors All contractor / vendor personnel having unescorted.eccess within.

protecteg areas at nuclear power piants would either be subject to the licensee's fitness-for-duty program or would be subject to a program maintained by the cuntractur which meets the provisions'of this rule. Written agreements between licensees.

and contractors /vencors will be required to ensure one of the

. two options _is implemented.

(e) Chemical testing for drugs, including ranoom testing and blind performance testing The fitness-for-duty rule includes the followir.g tyoes of chemical testing: pre-bao9i ng, unannounced ranoom, for-cause, dnd follow-up. Nearly all utilities are already using pre-employment and for-cause tests.

The proposed rule requires licensees to perform rander unannounced tests throughout the year under o sampling scheme which assures that at least 90 percent of the population subject to the rule is tested during the testing year. Any reduced testing rate applieo to persons who have tested negative in a 3

______.._.__.___._m.____m1__m__-. -

random: test would be at.least 30 percent per year (2-1/2%'per

~

. month).- The'st'off is aware that about two-thirds of the plants do'not presently practice randum testing. The renolning <

cne-third of the piants practice random testing, but at less than the specified' level. From available data, it cppears that the. current rates are lh the 5-percent to 25-percent range.

The proposed rule would' require ~ licensees to use blind performance test ~ specin. ens to ensure the accurucy and valid.ity of the testing process, i.e., onsite preliminu y tests and=

testing by a contract laboratory. The proposed rule would.

require licensees to sutmit these test specimens to the cor. tract-laboratory at an initial rate of 50 percent for the first '90 days, and 10 percent thereafter, not to exceea 500 and 250 samples, respectively.

-(f) Employee assistance program (EAP)

- Licensees are require'd to provide employee assistance programs (EAPs) as part of their fitness-for-duty activities. The EAPs offer short-term counseling, assessments, and referral services, and monitor treatment for licensee employees. All licensees currently have such EAPs in place. Generally, these EAPs are not' extended to include contractor employees. Cost estimates for such EAPs assume'that contractor employees will be included.

(g) Appeal procedures Each licensee is required to establish an oppeal process to its employees and contractor / vendor employees can appeal .

determinations that employees are not fit for duty.

(h) Reporting requirements Among a number of administrative requirements asscciated with the implementation and cperation of fitness-for-duty programs, 4

= _ _ _ _ _ _ _ _ _ _ _ _ i

q. .

is a system of' files and procedures for protectinc personal

! information, as well as for recorckeeping and' reportirig requirements.

5

o

~

Item 3: Potential change in.the risk to the public from the accidental

.offsite release of radioactive material; Response: Banning the presence or use of illicit substances at nuclear pcwer plants and controlling hcw workers at nuclear power plants use legal drugs significantly ircreuse the assurance that employees with unescorted access to the protected areas of nuclear power piants will be fit for duty. Although the Commission concludes that it cannot quantify the reduction in risk that will cccur when fitness-for-duty programs exist at all plants, the potential for significant increases in risk, as a result of increased rates of human error, has been clearly demonstrated.1 As discussed at length in the supplemer.tary information published with the proposed rule, substance use con impair d' worker's motor skills and judgment to the point that dCCidents attributable to neglect or error are significantly more probable.

The general upwaro trend in drug use in the United States is well known and the nuclear industry has not been exempt from this phenomenon. The Commission concludes that firm action is essential dt this time to ensure that nuclear power plant Workers remain fit for duty. The Commission concludes, for the purposes of this draft backfit analysis, that the proposed improvements in fitness-for-cuty programs prcvide a significant increase in the assurance of public health and safety and that the direct and indirect costs of implementing such improvements are justified in view of the increased protection such improvements will afford.

1 See NUREG/.CR-1879, " Sensitivity of Risk Parameters to Human Errors in Reactor Safety Studies for a PWR," Brookhaven' National Laboratory, January 1981 and NUREG 1050, "Probabilistic Risk Reference Document," September 1984.

6

qs . .

!K -

.'t ,

! Item 4: Potential ^ impact on radiological exposure of facility employees;

- Respons.,e : As' stated'ir, item 3 above, . limiting the presence'or use of ~ illicit substances and abuse of legal drugs by. workers at nuclear power Lplants- will provideLsignificant additional assurance that workers are fit for duty and that the rate of human error will not increase to the level that an unacceptable level 'crf risk wculo result.- An increasedSlevel' of-human error 1er the'workplaceL coulo also result in additional radiological exposure-to the individual. and to . fellow -

workers. In acdition, benefits will likely accrue to licensees from the potential reduction in absenteeism, lost worker productivity, medical ano insurance costs, and plant dcwntime. Finally, ti.e

-licensee's employees will benefit from the improved general safety of the workplace, and through their utilization of the education and support prograr..s available to deal with drug and alcohol problems.

W 7

u-_. -_m_. ___________m.__._ _ _ . . _ _ _ _ _ _ _ _ . _ _ _ _ . _ _ .

n.

y. .

V Item 5t Ir.stallation and' continuing costs associated with the backfit, includir.g the cost of facility dcwntime or the cost.-of construction

~

. delay;.

V l ' Response:-If_ all of'these backfit requirements were new to industry, the cost implications.'of such a prograrn would be more significant.2 ' In r eality bewever,: the- f!P.C and industry have been actively involved in fitness-for-cuty programs fer a number of years. In rr.10-1982, the Commission published a proposeo rule that would have required licensees to develop and implement written proceoures concerning.

fitncss for duty, und in 1986 the Commission-issued a policy statement on this subject. Since 1982, industry involvement on the part of the Nuclear Utility Maoagement and Pesources Cour.ul (NUMARC), the Institute of Nuclear Power Operations (INPO), the Edision Electric Institute (EEI) ard individuel utilities has resulted in each of the nucledr power plant licensees having a fitness-for-duty program in place. In meny respects these progrcms compare very closely to the requirements stated in the proposeo rule.

As a result,-the incremental burden to industry as a result of this action.is significi.ntly reduced.

The staff estimates that the incremental cost to incustry of adhering to the' proposed rule is on the order of $160.7 million to $243.?

million. Assuming a reactor population of 124, the per-reactor cost for an average remaining life expectancy of 25 years ranges from about $1.3 million to $2.0 million. About 55 percent of industry's tctal estimated cost will come from chemical testing.

The cost estimates include both incremental in.plementation and operating costs. The operatir.g costs capture cost impacts over the remaintr g life of the reactor pcpulation.

2 For example, in 1979 the TVA estimated that the annual :ost of just an alcohol abuse program was approximately $18.5 million.

8

o i

o ,

m Individual costs resulting from the necessary backfit ectivities discussed in item 2 obove are estimated as follows: l l '.

l (a) Written policy and procedures The cost for preparing backfit written policy ard procedores on  :

l fitness-for-duty programs is viewed as a one-time implementation cost. The NPC staff 4EEcn.es' that each licensee t.ill expenc: an 8 perscn-week technical staff end. management effort. Utility- .

4 technical staff will cost $50 per hour in 1907 coliars. This- i reflects a 1984 base wage rate edjusted by a factor of 1.8 for .4 fringe benefits ono plant management, eseglatec to 1987 dollars based on the GNP in;plicit price deflator.' l 1

Cost per licensee (320 he x $50) .... $16,000 Incustrywide cost ($16,000 x 55 licensees) .... $880,000  ;

(b) Awareness training program The cost for backfitting awareness training programs is viewed  !

as a Cne-time implementation Cost. The NRC staff estimates that  !

1500 employees and contractor personnel at each reactor will participate in a one-hour orientation program in a classroom setting. On the basis of generic cost estimates for training given in NUREG/CR-4627, the estimated cost per student hour is

$15.00, exclusive of the student's time away from work.4 The

$15.00 estimate incluaes the instructor's time for development, preparation, celivery, evaluation and revisiens to the course, 3 NRC has taken inaustry labor rates from NUREG/CR-4627, Gencr1c Cost Estimstes; Science & Engineering Associates, Inc., S. Cohen & Assccictes; Inc.,~an3 Mathtech, Inc.; Abstrect 6.3, " Industry Labor Rates," June 1986.

4 NUREG/CR-4627, Generic. Ccst Estimates; Science & Engineering Associates, Inc. , S. Cohen & Associates, Inc. , and Mathtech, Inc.; Abstract 2.2.3,

" Industry Cost for Training or Retraining Staff ana Writing or Rewriting Training Manuals, June 1986. ,

9

and allowances for the costs of instructional materials tr.o

' handouts. The student's time is voluid at $38.00 per hour.

This is the cverdge heurly salary paid to various utility

.workers adjusted for fringe tenefits and plant management anc escelstea'to 1987 dollars.5 Thus, the total hourly cost ci training each employee is $53.00 (i.e., $15 + S38).

The staff recognizes that newly hired wcrkers must also take the orientation program. Since new workers would have tekee. c fitness-for-duty orientation under the existing licensee prcgrams, the NRC staff views this cost as non-incren,ementel.

Cost per nuclear reactor (1500 employees x $52) .... $79,500 Industrywide cost ($79,500 x 124 reactcrs) .... 59,858,000 (c) Refresher training Licensees currently offer annual refresher training as part of their existing Gereral Employee Training (GET) progrems.

Although some licensees may need to provide more of such training, the proposed backfit requiremer.1 will impose little burcen on industry.

Industrywide cost = $0 (d) Written agreements with contractors / vendors Nearly cll licensees and their contractors / vendors have entered into written agreements concerning fitness-for-duty programs.

Although some of these agreements may need minor revisions as a result of changes to the licensee's policies and procedures, the effect here is expected to be restricted to those few instances 5 Ibid.

O 10

7 K

l: + '

_)

e , .,

f n which' formal agreements- with contractors in this regard do-r,ct exist. The'iicensee's effort,' expended in n.cdifying its own

' policies and-procedurcs, should provide a cuick and easy basis-for any needed changes to these agreerrents.

Industrywide cost = $0

-(e) Chemicel testing-for drugs, inclboing' randcrr testino er.'o blind pertornance testing .

1, -Pre-employment and for-cause testing The majcr costs incurred under this portion of the rule relate to the random testing and, to a lesser degree, to

-quality control measures such'es blind performance testing..

, Because nearly cll utilities already test their employees-

'(i) before hiring them ano (ii) for-cause, no aoditicnal costs were assumed for these typen of test.

2 Random-testing Although licensees could satisfy the Conmission rule by instituting varicus sampling strategies and testing rates, a number of samples each year equal'to 125 percent of the tested population is assumed for the purpose of-this analysis. For this analysis, the staff assunned that the rate for those plants already conducting random tests (about one-third) is 15 percent per year.

Other assumptions impr,rtant to this analysis include the following:

- 1500 emp Myees and contractors are to be tested randomly at each plant; existing plants have an average remaining life expectane at 25 years; l 11 1 4

l

_ = - _ _ _ -_ _ -- 1

4

.a

,j

- initial screening of each random test ccsts

$20.00;

- each confirmatory test costs $75.00;

- 5 percent of those sampled randomly require confirmatory testing for whatever reason; 75 percent of the nuclear power stactor units (93b conduct onsite preliminary screening tests, thereby requiring an additicnul screenir.g test at the contract laboratcry; collection of a semple for any test will take an average of 30 minutes of an employee's productive -

time; end

-- on the basis of data relating to ' industry labor rates and time-related cost adjustments contained in NUREG/CR-4627, Generic Cost Estir.iates, the average nuclear utility employee's hourly salary 9

and benefits were $38 in 1987.

a The estimated annual cost per employee is first based on the sum of: the cost of the random test; plus the cost of the confirmatory test, when necessary; plus the cost of the emplnyee's time away from his/her normal duties.

Substituting the assumed values in the equation gives:

$20/ initial screening test + .05 (confirmatory / random test) x $75/ confirmatory test + .5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> x $38/ hour =

$42.75/ random test for licensees not cor.cucting cesite preliminary screening tests. -

$20/ preliminary screer.ing test + .05 (confirmatory /

onsite test) x ($20/ initial screen + $75/ confirmatory test) + .5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> x $38/hr = $43.75/rundom test for licensees concucting onsite screening tests.

O 12 u______.__.--_------._ _ i

e. . - ,

'I ;

[.- 33-L.

n

.n .

The weighted: average . sum'of $43.50/ random test is thert i -. multiplied by the factors.that represent the industry u

experience in testing rates:' 67 percent of the plants will need.a-125-percent annual testing rate and 33 percent of the' plants willineed a 110-percent (125 percent -15 percent

= 110_ percent) annual testing rate.

I

. Substituting the assumed' values gives:

(1.25 x .67 + 1.10 x .33) x $43.50/ random test =

$52.22 per. employee per year -

b' This figure is multiplied by the istimated 1500 employees and contractor personnel per plant ano by 124 plants to

' obtain an estimated inaustry cost of $9.73 millicn per year. Assuming an: average plant life expectancy of 25 1 years and 4 percent disecunt rate, the industry's lifetime cost becomes $88.4 million. If a 5-percent discount rate is assumed, the lifetime cost is about $137.2 million.

Industrywide cost = $88.4 million to $137.2 million J ' Blind performance testing The costs presented here include the cost of purchasing specimens and having blind performance tests conducted on them by the contract labcratory. It is assumed-that:

75 percent of the nuclear power reactor units (93)conductonsitescreeningtests.

5 percent of the specimens tested on site would require further testing at the contract laboratory.

. A blind performance test specimen costs $'0.

5 13

i

- A " weighted" annual testing rate of 120 percent will be used for all units rather than the 125-percent and 110-percant rates used in the above Calculations.

Other assumptions used for random testing apply, e lhe estimated cost per unit for the initial 90 days fer 75 percent of the units doing preliminary screening tcsts onsite is:

1500 employees x 1.2 testing rate x 1/4 year (90 d6ys) x .05 (rate of positives) x .5 (rate of test specimens) = 11.25 specimens The specimens cost $50 each X 11.25 specimens = $562.50 80 percent of the specimens would only receive initini screening tests and 20 percent would need confirmatory tests: .

11.25 specimens x .8 x $20 (cost of initial screen) = $100 11.25 specimens x .2 x [$20 + $7E (cost of confirmation)] =

$213.75 Cost for 75 percent of units for first 90 days

($562.50 + $180 + $213.75) = $956.25/ unit x 93 units =

$88,900 b The estimated cost per unit for the initici PC cays for the remaining 25 percent of the units is:

1500 employees x 1.2 testing rate x 1/4 year (90 days) x .5 (rate of test specimens) = 225 spec'imens 14

v- .) .

K The specimens' cost $50.00 each x 225 =-$11,2EG

' 80 percent of.the. specimens would only' receive initial ~

screening tests and 20 percent would neeo confittatory tests:

I,y 225 specimens x .8 x $20 (cost.of' initial screen) C

$3600, 225 specimens x .2 x [$20 +- $75 (cost of -

confirmation)] = $4275 Cest for 25 percent of units for first 90 days eauals -

($11,250:+ $3,600 + $4,275) + $19,125/ unit x 31 units

= $592,900 c .The estimated annual cost per unit for 7F percent of the units doing preliminary screening, tests on site aftet4 the initial 90 cays is: .

1500 employees x 1.2 testing rate x .05 (rate of positives) x .1 (rate of test specimens) = 9 specimens 9 specimens / year x $50/ specimen = $450/ year L 80 percent of the specimens would only receive ir.itial screening tests and 20 percent would need confirmatory tests:

9 specimens x .8 x $20 (cost of initisl screen) =

$144/ year

r. 9 specimens x .2 x [$20 + $75 (cost of confirmation)]

= $171/ year 15

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The estimated. annual. cost;for_75 pcrcent of the units

' equals:

l --

($450/ year' + $14a/ year +-$171/ year) = $765/ unit x 93 units' = .$71,000/ year d The estimated annual cost per. unit for 25 per' cent of the Lc _

ur.its after.the. initial.90.ceyss is:

1500 employees x 1.2. testing rate x .1 (rote of specimens)=;180 specimens 180 specimens x.$50/ specimen = $9000/ year 80 percent of. the specimens wculd only receive initial-screening tests eno 20 percent would need confirmotcry tests:

380 specimens x .8 x $20 (cost of initial screen) =

$2880/ year 180 specimens x .2 x [$20 + $75 (cost of confirmation)) = $3420/ year The estimated annual cost for 25 percent of the units equals:

($9000/ year + $2880/ year + $3420/ year) = $15,300/ unit x 31 units ='$474,300/ year e In summary, costs for the initial 90-day period total

$681,800 (i.e., $88,900 + $592,900), and recurring annual

- costs total $545,400 (i .e. , $71,000 + $474,300). Assuming an average. plant life expectancy of 25 years, the industry's lifetime cost at a 10-percent discount rate 16

=___-:-_____-.-----. ,- -

becomes $5.6 million and at c 5-percent discetnt rate the-lifetime cost is about $6.t million.

Industrywide cost = $5.6 million to $8.4 million (f) Employee assistance programs Including centractor personnel in the licensee's empluycc-assistance prcgram hould result ~in an increase the licensee's current EAP staff cric is estimated to require that one additional professional staff person per power reactor be hirec dt $50,000 per year. This will cost the industry 56.2 million annually. On the besis of a 10-percent.and 5-percent alsccunt rate, the lifetime cost to the industry on a present worth basis is estimated to range from $56 million to $E7 million, respectfully, in 1957 collars. -

Industrywide cost = $56 million to $87 million.

(g) Appeal procedures.

Procedures of this nature are either already a part of the utilities' personnel practices, or will be under the industry standard for access authorization programs. Therefore, this requirement will impose no additional burden on industry.

Industrywide cost = $0 (h) Repcrting requirements The staff's assessment of the utilities' fitness-for-duty programs suggests that approximately 50 percent of the existing programs fully meet these requirements, and that for the remaining 50 percent, only some mcdest increase could be required. Recognizing that these latter utilitics already have cn their staffs personnel to manage and aaminister these 17 j i

- - - - _ _ _ _ _ - _ _ - _ _ _ - _ -- i

m' L-j; i'

programs, and that.these requirements constitute only a small increment to their current level of effort, the staff conclLdes that these requirements could be accommodated with no or minimal added cost.

Industrywide cost = $0 D

o 18

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O l_ Item 6: The potential safety impact of changes in plant or operational complexity, including the relaticeship to preposed'and existing regulatory requirements; L _

M ponse:

o e The proposed backfit does not alter the plant or operatioriel con:plexity. It does not irivolve a reducticn in a margin of safety since neither plant design nor cperating preceoures are changed. Iri addition, it does riot alter any safety-reicted: design rasis or the facility.

Therefore, the proposed backfit neither creates the possibility of a r.ew or different kind of cccident nor dces it invcive an increase in the probability or consequence of an accident previously evaluoted.

4 e

4 e

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Y a.

Item 7: The estimated resource burden on the NRC associated with the proposed backfit and the availability of such resources; Response: In addition to overseeing the licensees' fitness-for-duty prograns, NRC staff will need to address'the matter of periodic inspections, prepare event reports, initiate reactive inspection programs, ar.c review reports and other written submittals. lc t limited degree, these activities are currently teing conducted with prcsent staff.

The staff estimates that one full-time position at headquarters plus two to five staff positions in the regional offices will be required for program management, ir,spections, ar.d general oversight of the utilities' fitness-for-duty programs. Ar. estimated range is proviced because of the uncertainties of the extent of the reactive inspection effort. For example, one region expenced more than one FTE in FY87 investig,ating fitness-for-cuty allegations.'

Estimates of NRC labor rates (NUREG/CR-4627) suggest using a value of

$72,000 per NRC professional staff-year. This would cover salary and fringe benefits for a mid-level position as well as secretarial u o i management support to that individual. The annual NRC cost for this action at the upper bounds is, therefore, 6 staff x

$72,000/ staff-year = $432,000/ year.

The 1987 present worth value of the estimated annual cost over a 25-year period is about $3.9 million using a 10-percent discount rate.

A 5-percent discount rate gives a lifetime cost of approximately

$6.1 million. The staff finds that the estimated resource burden on the NRC associated with the proposed backfit is 15.9 million to $6.1 million. ,

These resources will be obtained from currently bucgeted NRC safeguards resources, thereby leaving NRC safeguards programs with unbudgeted ' requirements of that amount.

20

Item 8: The potentiel in'psct of differences in fccility type, design, or age on.the relevancy and practicality of the proposed backfit; Response: The proposed backfit is of an administrative nature and independent of the fccility's type, design, or age. Therefore, there should be no differences in potentiel irrpact betweer, the various facilitics cn a per year basis. The tctal cost to any ftcility will be proportiorml to the number of' remainisig years' that the facility is operated.

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21

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Item 9: Whether.the prcposed backfit is interim or final and, if interim, the justification for imposing the proposed tackfit on an interim basis.

Response:-The proposed backfit 6ction is anticipated to be the staff's final position regarding fitness for duty.

4 1

22 l

e.

Because this rulemaking- adds a' new rule to an earlier Commission 7

Conclusion:

' position, a draft backfit analysis.has been prepered pursuant to.

10 CFR 50.109.. In the analysis,.the staff finds that the new T ' rule. will significantly increase _ the.overall protection: of -

public health and safety and that the direct and indirect costs of implementing the new rule are justified in view of. the increased' protection. The finding is preliranary and:the Cwmission. requestss comments on applying: ther backfit' ruleL to this revised position as presented in the draft analysis.

Under the backfit rule, the- Commission has two options with respect to backfits it 11nds are needed. The Ccnn.1ssion can

'make the required finding of substantial. increase.in everall protection of public health and safety, or it can decide that the rule in question is necessary to provide adequate protection.

to the health and safety cf the public and thus it. not subject to-backfit andlysis. Although the draft beckfit analysis adoptt-the'first option, the Commission also requests comment on which of these.two options is the more appropriate-for this rulemaking.

l-l i

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1. 'a (81 ,9'9 4 s . UNITED STATES l

f ' ' ,,g s . NUCLEAR REGULATORY COMMISSION .

o' ;E W ASHINGTON, D.C. 20556 7

! 'May 8, 1989

' CFFCE OF THE .

SECRETARY

' MEMORANDUM lFOR: Victor Stello, Jr., Executive Director. '

for Operations FROM:

Namuel J. Chilk, Secretary

SUBJECT:

. STAFF REQUIREMENTS - AFFIRMATION / DISCUSSION AND VOTE, 11:30 A.M.', THURSDAY, APRIL 27,.

p 1989, COMMISSIONERS' CONFERENCE ROOM, ONE

! WHITE FLINT NORTH,,ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE)

I. SECY-89-030A'- Final Rulemakina - Fitness-For-Duty Proarams.

The Commission, by a 5-0* vote approved issuance of a final  ;

Fitness-for-Duty Rule which requires licensees authorized to construct or operate nuclear power reactors to implement a fitness-for-duty program. The program is intended to provide reasonable assurance that nuclear power plant personnel are reliable,. trustworthy, and not under the influence of any substance, legal or illegal, or mentally or physically impaired from.any cause which adversely affects their ability to safely P and: competently perform their duties.

The rule was approved as contained in SECY-89-030A subject to deleting the modifications made by the staff to Section 2.7(g)(2) and restoring the section to the original language approved by the Commission as noted in the attached copy of page 131. The staff modifications to Section 2.7(g)(2) would have allowed presumptive positive results of preliminary testing to be provided to the Medical Review Officer, who could then inform

' licensee management if he or she concluded that the individual presented a hazard to self or others. As a safeguard for individuals undergoing random drug testing and to comply with Health and Human Services guidelines, the version approved by the

. Commission requires that positive results be confirmed prior to their being provided to licensee management. Chairman Zech and Commissioner Carr, while approving the final rule, would have preferred to retain the staff proposed language in Section 2.7 (g) (2) and in addition would have lowered the cut-off level for marijuana screening tests to 50ng/ml.

• Section 201 of the Energy Reorganization Act, 42 USC Section 5841, provides that action of the Comaission shall be determined by a ' majority vote of the members present.' Commissioner Carr was not present when this item was affirmed. Accordingly, the formal vote of the Commission was 4-0 in favor of the decision.

Commissioner Carr, however, had previously indicated that he

'wc,uld approve this paper and had he been present he would have affirmed his prior vote. ,

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M L G J_c M W L _ Of1 l

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The Fed'eral Register Notice should be modified'as noted.above (along with any additional editorial or needed consistency-changes) and should be forwarded for signature and publication.-

- (EDO) (SECY SUSPENSE: 5/26/89)

Copies:- .

Chairman Zech Commissioner Roberts Commissioner Carr

.. . Commissioner Rogers' -

Commissioner Curtiss

' GPA' PDR - Advance DCS 24 O-e

^ ^ " ' ' " " - - ' - - - - - _ . _ _ _ . _ . _ _ _ _ _ . _ _ _ _ _

g' ~

j, (3) The analytic procedure for confirmatory analysis of blood specimens 1 voluntarily provided by individuals testing positive for alcohol on a breath test shall be gas chromatography analysis.

(4) The list of substances to be tested and the cut-off levels are 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 the inclusion of additional substances and other concentration levels.

-(5) Confirmatory tests for opiates shall include a test for 6-monoacetyl-morphine (MAM) if the screening tast is presumptive positive for morphine.

(g)"ReportingResults."

(1) The HHS-certified laboratory shall report test results to the licensee's Medical Review Officer within 5 working days after receipt of the specimen.by the laboratory. Before any test result is reported (the results of initial tests, confirmatory tests, er quality control. data), it shall be reviewed and the test certified as an accurate report by the responsible indivioual at the laboratory. The report shall identify the substances testea for, whether positive. or negative, the cut-off(s) for each, the specimen number assigned by the licensee, and the drug testing laboratory specimen identifice-tion r. umber. Theresults(positiveandnegative)forallspecimen? submitted at the same time to the laboratcry shall be reported back to the Medical Review Officer at the same time when possible.

(2) The HHS-certified laboratory arc any licensee testing facility shall report as negative all specimens, except suspect specimens being analyzed under special processing, which are negative on the initial test or negative on th'e confirmatory test. Specimens testing positive on the confirmatory analysis .

shall be reported positive for a specific substance. Presumptive positive .

results of preliminary testing-at the licensee's testing facility will not be reported to licensee management, + t % ":di::1 n:. 6 ^ " i::: d;;; 'r::

th:0, i:::d Or. r: d . :' th: ;;;rtit;;;: r;;.10 , th; '-di.id::? ;;r; tit ::: :

h:::r  : ::1' :r th:r:.

(3) The Medical Peview Officer may routinely obtain from the HHS-certified laboratory, and the laboratory shall provide, quantitation of test results. The Medical Review Officer 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 Section 3.2.

131

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