ML20011E596

Informs Commission of Status of Actions Directed by 890322 Staff Requirements Memo,Other Related Developments of Interest & Recommendations Re Future Actions to Resolve fitness-for-duty Rule Issues

ML20011E596
Person / Time
Issue date:	02/07/1990
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
TASK-PINC, TASK-SE SECY-90-040, SECY-90-40, NUDOCS 9002160192
Download: ML20011E596 (14)

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.....J esse...ees.o.ee.ee...eee POLICY ISSUE SECY-90-040 (NEGATIVE CONENT)

For:

The Connissioners o

From:

James M. Taylor Executive Director for Operations

Subject:

STATUS OF STAFF ACTIONS TO RESOLVE FITNESS-FOR-DUTY RULE ISSUES

Purpose:

To inform the Cornission of the status of actions directed by the staff requirements memorandum (SRM) of March 22, 1989, other related developments of interest, and recom-mendations concerning future actions.

Background:

In an SRM dated March 22, 1989, the staff was directed to further explore the need to amend 10 CFR Part 26 to

. add benzodiazepines and barbiturates to the testing protocol and to lower the cutoff levels for marijuana and amphetamines on the basis of information possessed or received by the staff.

In this regard, the staff was asked to specifically request that the Secretary of the Department of Health and Human Services (HHS) review and comment on the advantages 6no disadvantages of this action and that the Secretary also review the merits of this action for NRC and other Federal programs. The staff was also asked to provide recommendations on whether an amendment to the rule should be proposed based upon the information available.

01senuion:

In a letter dated July 25, 1989, to Dr. Louis Sullivan, Secretary of HHS, Chairman Carr requested the expert advice of HHS on the merits of the above action (see

• ).

On November 21, 1989, Secretary Sullivan responded that HHS did not support including the additional drugs or lowering the cutoff levels for certain drugs (see Enclosure 2).

Secretary Sullivan also took exception to the provisions in 10 CFR Part 26 for permitting onsite testing. The letter stated that these and other issues would be addressed during an upcoming National Institute on Drug Abuse (NIDA) conference. The NIDA conference,

" Consensus Conference on Technical, Scientific, and NOTE:

TO BE MADE PUBLICLY

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g CONTACT:

L. Bush AVAILABLE WHEN THE

/Q x20944 FINAL SRM IS MADE fg AVAILADLE 801)d/60/

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Procedural Issues of Employee Drug Testing," was held November 29 - December 1, 1989. The purpose of the conference was to bring representatives of the scientific, business, and medical communities together with Government l

regulators, laboratory pers,onnel, management, and labor to e

identify and discuss issues involving employee drug testing.

NIDA plans to publish a report of the consensus recomenda-e tions of the attendees (320, total) by February 1990.

It t

was emphasized at the conference that the HHS Guidelines and the conference recommendations concern a riational drug o

testing program rather than a program to address public safety issues. Several statements were mace asserting that where public safety was a concern, more stringent standards should be mandated by the responsible regulatory body.

1 The consensus recommendations by the conference committees of the'most direct interest to the NRC include the following:

1.

Cutoff levels for initial screening and confirmation tests should be reduced.

Specific recommendations were to reduce cutoff levels for THC (marijuana) from 100 ng/ml for initial screening to 50 ng/ml (there was J

considerable support to go to 20 ng/ml); to reduce initial screening for cocaine from 300 to 200 ng/ml, i

with a corresponding reduction in the confirmatory test; and to reduce amphetamines from 1000 to 500

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ng/ml and possibly to 300 ng/mi for the initial screenino, deoendino upon information to be obtained.

1 2.

Additional drugs should be included in the forensic drug-testing protocols. Spec 1fically, drugs to be tested should not be limited to Schedules I and II of j

the Controlled. Substances Act, but should be expanded

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to include benzodiazepines, barbiturates, methadone, methaqualone,' ethyl alcohol, and volatile solvents.

1 Also, the option to add drugs should reside with the j

employer (eliminating the requirement in Federal and j

Department of Transportation (DOT) programs to requestwaivers).

3.

Onsite screening tests may be appropriate when safe-guards are provided to ensure the accuracy of results.

j The safeguaros recommended were identical to those required by 10 CFR Part 25. All five committees that addressed onsite testing supported this concept.

4.

The batching requirement for specimen reporting should be deleted so that management 1as quicker access to the results. A second committee recommended that the requirement be eliminated for pre-employment and for-cause testing.

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l The Commissioners l N!DA officials said that the recommendations wocid be considered and that appropriate revisions to the HHS Guidelines would be proposed to the Secretary, would be published for public comment, and so forth; this process j

would take at least 1 year. The staff believes that 10 CFR Part 26 should not be revised to add benzodiazepines and barbiturates to the testing protocol or to lower i

the cutoff levels for marijuana and amphetamines before i

NIDA revises the " national policy." Pending revisions i

to the HHS guideline, it should be noted that the current rule is sufficiently flexible for licensees to accomplish additional drugs to be included on the drug-testing conference recommendations 1 and 2 above, which concern protocols and reduced cutoff levels. Postponing amending the rule will also provide time in which to gather and evaluate initial exaerience in implementing the programs required by 10 CFR Part 26.

On December 1, 1989, the DOT published modifications to 49 CFR Part 40 (54 FR 49854), the D0T's. version of the HHS Guidelines. The D0T eliminated batch reporting re-

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quirements and reduced the number of blind performance test specimens from 50 percent for the first 90 days and 10 percent thereafter to a flat rate expressed as three blind specimens per 100 employee specimens submitted.

The portion of the Federal Register Notice that summarizes all of the DOT's changes can be found in Enclosure 3.

Following publication of DOT's rule, several licensees contacted the NRC staff,to determine if the Commission was going to reduce the number of required blind performance test specimens. Since the the greatest number of per-formance specimens would be used during the first 90 days of program implementation ano many licensees have already implemented taeir program 1 to 3 months before the imple-mentation date of January 3,1990, no significant advantage would be realized by reducing the rate of performance specimens. Also, D0T action was motivated by the fact that 12 million tests a year would be conducted under DOT rules and a 50-percent rate for 90 days would be an unrealistic burden on employers and the testing laboratories. The staff believes that the HHS Guidelines (and Appendix A to 10 CFR Part 26) provide employees added assurance that the tests results are accurate and that the Comm1ssion should defer any reduction in the performance testing rate until HHS acts in this matter, Recommendation:

That 10 CFR Part 26 not be amended to add benzodiazepines dnd barbiturates to the testing protocol and to lower the cutoff levels for marijuana and amphetamines until HHS Ye v

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The Comissioners,

has amended its " Mandatory Guidelines for Federal Work-i place Drug Testing Programs" and until experience with the required nuclear industry programs has been evaluated.

1 Unless otherwise instructed by the Comission, the staff will not initiate rulemaking to amend 10 CFR Part 26 to J

address drug-testing cutoff levels or addition of drugs l

to the protocol until HHS revises its guicelines. We will keep the Comission informed of the status of the

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HHS review.

L Coordination:

The Office of the General Counsel has reviewed this paper and has no legal objection to it.

/

J mes M xecutive Director for Operations

Enclosures:

1.

Letter from Chairman Carr dtd7/25/89(w/oenclosures) 2.

Letter from Secretary Sullivan, dtd 11/21/89 3.

Extract from the DOT Rule SECY NOTE:

In the absence of_ instructions to the contrary, SECY will notify the staff on Thursday, February 22, 1990, that the Commission, by negative consent, assents to the action proposed in this paper.

DISTRIBUTION:

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j wAssiwotoN, D. C. 20666 July 25, 1989 CHAIRMAN i

L The Honorable Louis Sullivan Secretary of Health and Human Services i

Washington, D.C.

20201 I

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Dear Mr. Secretary:

i The Nuclear Regulatory Consnission (NRC) recently published a final rule requiring our licensees to implement fitness-for-duty programs. The intent of the rule is to ensure that nuclear power plant personnel are not under the i

influence of any substance, legal or illegal, or n.entally or physically impaired from any cause that could in any way adversely affect their ability to safely and competently perform their duties. During development of the rule, the Commission decided that the minimum standards for drug abuse and drug testing in the consnercial nuclear power industry should be consistent with those for Federal programs developed in accordance with Executive Order No.

12564, dated September 15, 1986, and Section 503 of Public Law 100-71. How-ever, based on the-experience of our licensees, the Comission is concerned that the cutoff levels for marijuana and amphetamines should be lower and that barbiturates and benzodiazepines should be added to the panel for drugs for which testing would be administered.

Therefore, the Consnission requests the expert advice of the Department of Health and Human Services (HHS) on the merits of including additional drugs and lowerino the cutoff levels for certain drugs in an amended NRC Fitness-For-Duty Programs Rule. The specific cutoff levels that we are proposing are listed in, and our specific reconsnendations for additions to the mandatory panel-.of drugs are contained in Enclosure 2.

Comments on the rule from the regulated industry were overwhelmingly in favor C

of lower cutoff levels ~ for marijuana.

Information provided to the NRC indi-cates that approximately two-thirds of our licensees have established cutoff levels for the initial screening tests for marijuana lower than 100 ng/ml.

Seventy-three percent of all the positives reported by the industry were between 50 and 100 ng/ml. Two licensees who were using a cutoff of 20 ng/ml were able to provide extensive data showing that 80 percent of their presump-tive positive tests were between 20 and 100 ng/ml. While concerns have been expressed that lower cutoff levels may result in more false positive tests, we understand that no false positives were reported nor claimed as a defense in any case using a 20 ng/ml cutoff level for marijuana.

Based on this data and the additional infonnation provided in Enclosure 3, we believe that a change in the cutoff levels is warranted.

Industry consnents on the rule also supported the addition of barbiturates and benzodiazepines to the required test panel.

Infonnation provided to us indi-cates that over 60 percent of our licensees are testing, or plan to test, for these drugs. Additional information supporting our consideration of adding

'these drugs to the test panel in an amended NRC rule is contained in Enclosure 4.

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, l Should HHS advice be supportive of an amended NRC rule, I also request HHS to consider revising the " Mandatory Guidelines for Federal Workplace Drug Testing Programs." The Connission believes that a revisec guideline incorporating these changes and applicable to all Federal programs may strengthen the Government's efforts to ensure a drug-free Federal workplace and allow NRC to apply uniform fitness-for-duty standards and testing requirements to our D

licensees and employees.

You should also be informed that the NRC, in finalizing its rule, made pro-cedural modifications to further protect individual rights. The appendix to the NRC rule specifies measures to prevent subversion of the testing process, permits the' splitting of specimens, requires that confirmation testing for opiates include a test for six monacety1 morphine (MAM), specifies protection of records, and establishes procedures for appealing positive determinations.

To assist you in reviewing our proposal. I have enclosed a copy of NRC's final Fitness-For-Duty Programs Rule (Enclosure 5) and the NRC publications relating to the development of the final rule (Enclosures 6-8).

We would appreciate your connents as early as possible on amending the NRC rule.

NRC licensees are required to meet NRC's Fitness-For-Duty Programs Rule by January 3,1090.

If a rule amendment is deemed necessary, it would be useful to issue the amendment before our licensees have fully implemented their programs in

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accordance with our rule. 'We world appreciate your views on revising the

" Mandatory Guidelines for Federal Workplace Drug Testing Programs" within a reasonable time.

Sincerely, x? W.

Kenneth M. Carr

Enclosures:

1.

List of Specific Cut-Off Levels Requested 1

2. - List of Additional Drugs Reconnended 3.

Discussion Paper: Amphetamines and Marijuana Cutoff Levels i

4.

Discussion Paper: Barbiturate and Benrodiazepine Urinalysis 5.

Final Rule:

10 CFR Parts 2 and 26,

" Fitness-For-Duty Programs" (54 FR 24468) 6.

NUREG-1354, " Fitness For Duty i

in the Nuclear Power Industry:

t A peview of Technical Issues" i-7.

NUREG/CR-5227 " Fitness For Duty in the Nuclear Power Industry:

Responses to Public Comments" 8.

NUREG/CR-5227, Supplement 1

" Fitness For Duty in the Nuclear Power Industry: A Review of Technical Issues"

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N9V 21 19E?

4 The Honorable Kenneth M.

Carr Chairman U. S. Nuclear Regulatory Commission Washington, D. C. 20555

Dear Mr. Chairman:

Thank you for your letter regarding the Nuclear Regulatory Commission (NRC)

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rule for fitness-for-duty programs and requesting the expert advice of the Department of Health and Human Services (HHS).

I am awafe that staff at the National Institute on brug Abuse (HIDAs, a comporsent of the Alechol, Drug Abuse, and Mental Health Administration, have been providing advice and technical assistance to your office of Nuclear Reactive Regulations and their contractor, Battelle Human Affaire Research Centers, for more than a year.

NIDA is responsible for the Mandatory Guidelines for Federal Workplace Drug Testing Programs. Throughout this time, HHS staff have consistently advised the NRC against:- 1) the inclusion of additional drugs in the rule,

2) permitting lower cutoff levels than those specified in the Mandatory Guidelines, and 3) the inclusion of provisions to permit onsite testing.

Furthermore, I am aware that the NRC was strongly advised by the Department of Justice (DOJ) against including these provisions in the final rule because it could seriously jeopardize the litigLtion position of the DOJ in defending the constitutional issues raised about federally mandated drug testing.

We are aware that the public comments on the NRC proposed rule were overwhelmingly in favor of lower cutoff levels for certain drugs.

however, - based on our experience in certifying laboratories for Federal Workplace Drug Testing Programs, it is quite apparent that many laboratories, at this time, do not have the capabilities of operating on a day-to-day basis at the lower threshold levels permitted under the NRC rule.

It is for these reasons that HHS has advised the NRC in the past against permitting the use of lower cutoff levels. We are, however, looking very carefully into the maximum sensitivity levels of the assays themselves as well as the capacity cf the laboratories to perform these assays at lowur threshold levels.

We anticipate convening a consensus conference on these and other issues which may result in making recommendations regarding changes in the cutoff levels within the next

'6 months.

With regard to the question of adding barbiturates and benzodiazepines to the required test panel, the HHS Mandatory Guidelines are authorized by Executive Order 12564 and P.L. 100-71 (sectien 503) which limit the Federal Workplace Drug Testing Program to Schedule I and Schedule II drugs.

Few barbiturates

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Page 2 - The Honorable Kenneth M.

Carr t

i and none of the benrodiazepines are included.in Schedule I or II.

There are hundreds of legally prescribed medications which contain small amounts of i

barbiturates.

These drugs are widely used in the treatment of seizure disorders.

Additionally, the incidence and prevalence of illicit barbiturate abuse is relatively minor compared to use of marijuana, cocaine, and the other illicit drugs.

It is believed, therefore, that even those barbiturates included in Schedule II should not be included in the test battery unless there is a reasonable suspicion of barbiturate abuse.

Although you did not mention it in your letter, I am aware that your final

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rule includes provisions which permit the use of onsite testing.

We do not recommend the use of onsite testing due to the increased probability of inaccurate and unreliable results occurring through the use of onsite testing kits, and the significant risk to individual confidentiality. We are exploring options concerning the use of onsite testing with regard to situations where there are significant safety risks such as in the nuclear industry.

However, we feel that there is considerable risk to the entire Federal program by permitting the use of.onsite testing, and at t his time cannot condone its use.

Therefore, in terms of your request for expert advice as to the merits of including additional drugs and lowering the cutoff levels for certain drugs as specified in your letter, this Department cannot support the NRC rule.

The addition of Schedule III and Schedule IV drugs is not consistent with the HHS Mandatory Guidelines, and we feel that such changes could weaken the confidence of the American public in the entire Federal drug testing program which we have worked so hard to develop.

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.The NRC will receive an invitation to the consensus conference mentioned above. This forum is designed to seek an update on the scientific and technical aspects of the Mandatory Guidelines.

Invitees will include scientists and laboratory experts who have advised NIDA and the Department in the past, as well as interested individuals from other Federal Agencies!

business and industry, and the drug testing community.

Sincerely,

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Louis W.

Sullivan,'M.D.

Secretary W

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ENCLOSURE 3 l

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Federal Regleter / Val. 54. Ns.130 / Friday. Dec:mber 1.1989 / Rules and Regulatirne 49063 It should be pointed out that, se an procedural rule applicable to all ein for altering the standards for ice of the Secretary of Transportain operating administration rulee rathe rticipation in the DOT testing le. Part 40 is subject to the exemptio than incorporating or referencm3 t p rom. which must reme high in ocedures of 49 CML 6.11-6.13. Unde DHHS Guidehnee or a modificatio of or r to protect the inte y of the t se procedures, any party may them in six individual rules does t pt-m.

Ition the Secretary for en enemp on affect the validity of the rulemak g

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opect to led absm, a to rule.ne grounds on which an es. fit should also be point out commen ugguted at there may be a ese ption may be granted are na w.

at the DHHS Guidelines them elves federshem pact n state and local An emption le granted only on e ere published after an opport nity for laboratory ifi ation standards The basi of a showing of special blic coinment.)

requiremente the use of DHil5 ire stances.not contemplate in the ter reviewing the comme e certified labo i es does not n an>

ulem king, that make complia with eining to testing procedu o made in way affect pree pt state or local the se orally applicable rule easible.

re onee to the ela operating laborstory rtificat n standards, ty spe talcircumstances we een a inistration NpRMe and e which continue to pply without irc ances peculiar to the pplicant, co mente on the interim ft I rule, the change thm their amb part 40 s hich a not generally appl' ble to a De rtment is convinced I the issues simpi osye that for purpo e of a new lass of rties. An exempti request is hav been thoroughly reis and Fed al testing requirement. ifilS not a lo for reasserting ents or resp ded to, and that a et ce ification is required in ad ion to nositione nsidered d ' the oppo unity to comment an SNPRM atever standards laboratone must ulemak. or for seeking de facto woul only delay necus ry revisions of eet under state or local law.

mondme to the rule. N r are the int rim fmal rule, ra. er than obtain semption ented on basis that the additio al useful sugge ions. Therefore.

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"*on Analyels of Changes

pplicant w uld find it ferable to the De rtment is p edmg to a final iroceed in a ey other an that set rule at is time.

no Department is pnnting the irth in the e.

A few mments el questioned the complete text of part 40. as amended, in On the basi that - e testing is such underlyi legal auth rity for the rule.

order to facilitate its un by affected bad idea the no set f procedures ~

The rule i en Office f the Secretary parties. As a guide to the changes made

.uld redeem i som commente urged rule, publi hed und the seneral in this amendment, this section of the

.olishing the e ures (and.

rulen.eki authon available to the Preamble liste the changes which this nplicitly, the e ti DOT drug testmg Secretary o Trans rtation. The amendment makes to each section of rogram as well e Department is operating a inis ation rules, issued part 40 sell aware of th ntroversial nature under the se ty d/or grant program Heading. De Table of Contents is f drra testing.

Department is rulemaking a th ty of the several changed by deleting the reference to

>mmitted to tuting as being administratio, re the source of the subpart C and by changing the number acessary for tr portation safety, requirement th i regulated employers of the section on the use of DHHS hese proced re the best means of use the part 40 [rocedures.

certified laboratories from 40.41 to 40.39.

s hlch the Depa nt is aware to Other comm

' to concerned the ne reference to the DHHS certification nsure that test ng felt and accurate.

regulatory eva u tion, regulatory standards has been deleted (as has the cher commen re ed abolishing the flexibility sta m nt, and federshem old appendix A itself); appendix A now ocedures or skin them voluntary so statement.

co ta of drug testing, and contains the drug tetting custody and ist employe could evloe their own of testmg oc roi to tnese procedurva, controi sorm. A reference to en v.s.C.

• ocedures.

are impose on res lated parties not by 322 has been added to the authority Given the n mber o employers part 40 but y the el operating citation. This citation, which to to the vered by D T drug t sting rules, and administra on rules.The costs were statute containing the Secretary's i

a varying r sources a allable to them, taken into ccount in e regulatory general rulemaking authority, was Departm nt believe that consistent evaluatio e for those les and do not inadvertently omitted from the

>cedures at protect e accuracy need to b repeated in onnection with publication of the interim fmal rule d integri of testing a d successfully part 40-Section 40.3 Defm/tsons. A definition ilance th legitimate int rests of Thee e can be said as a general of" blind sample" has been added. An nployers and employees ould be matter, r the impact of art 40 on small addition has been made to the defirution fficult t achieve under e ch a entities One point made this of " collection site person." providmg

. olunta " approach.

conne ton was that the r uirement of that unless it is impracticable for any Some omments question d the part for DHHS certifica on of other individual to perform this function.

4hdity f issuing an interi final rule, labor ories could reduce o portunities a direct supervisor of an employee shall

.ying at an NPRM should ave been for e alllaboratories.The epartment not serve as the collection site person sued ret or that a supplem ntal notice does ot believe that this is e case.

for a test of the employee.nis Ipro sed rulernaking (SNP

) should DID certification is evalle e to any definition also clanfies what c les ed before a revised fin rule. The labo story meeting DFDIS req trements.

• monitoring" of a drug test means.

Jepa ment does not believe t t either wh! h do not include a size mi Imum.

Definitions have also been added to i cal ed for. Before the issuanc of the The 37 laboratories certified to ete by distinguish three kinds of containers nte m final rule in November 1 DH (S include smaller as well a larger used in the collection process: the

.o n ente.rs bad the chance to a dress lab ratones. While some labora nes, collection container, specimen bottle.

he pplicability of the DIDIS in uding smalllaboratones, may and shipping container.

Gu elmas to the DOT drug testin co$clude that the business they w uld Section 40.23 Pnporotion for Testing er ram in the context of six oper ting galn through DFDiS certification la ot Paragraph 40.23(al. concerning the drug i ministration NPRMs.not the edfficient to make DIUiS certificati testing custody and control form, has partment decided, as a matter o i worthwhile to pursue, the Departme t been changed in accordance with the ministrative convenience, to issue one does not believe that this makes a ca e revised form. Paragraph 40.23(b) now l

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49864 Federal Registee / Vol 64. No. 230 / Frklay. December 1. tese / Rulee and Resulations centains, as subpatopoph (1), a values of 8 40.29 do not applyk A new Secteun da.3J Aaports cad Acnew rf eequirement for the use of a sealed subparagraph (iii) apacities that, except Aesu/a. In paragraph (al the ward specimeo r.ootainer, which wiD be for split samples under subparagraph "resuhe" at the end of the first acntenc.c presented to the employee for unasalms (ii). no portion of the saanple cc:lacted hse been changed to the wotde at the begmning of the test procedure.

under this part may be used for any "conhrmed posiuse results from the The esistmg language of paragraph (b) purpose other than drug tasting required laboratory" as a darshcabon to has been renumbered as subparagraph under DOT regulahone..

emphae6se that a review of negative (2).

A new paragraph U) has baan added, resulte la not necessary. At the end of Section 40.23 Specirnen Collection concerning employees requinas medical this peregraph, a sentence has been

,1 Procedures. Subparagraph 40s(e)(:)(i) attention. The paragraph provides that if added to make esplical that the htRO i

has been amended by deleting the the collection to bems made froen an review shallinclude regiew,of the drug

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wotde at the end concarning the oral employee in need of medical ettenbon testing c.hein of custody form to ensure temperature mot equallms or amoeedtag (e s.,in a post accident test), necessary that it is complete and sufficent on its that of the sprumen. The tarnperature medical attenuon shall not be delayed face.

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range provision has been dartfied.

in order to take the sample, in paragraph (b). a sentence has been Subparerrsph (f)(2) containa new language at the end providmg that on s,cfjan 4o,3 fo 3o,,gofy A nofy,,,

added aller the first present sentence emplo> ce request, the collect on site Procedurea. Subparagraph 40.:9tg)(1) statsng that the MRO shall not be an person shall abow his or her has been amended by deleting the last emp}oyn of the laboreton conduchng i

oestence. which required " batch the drug test unless the laboratory identification to the employee. Language reporting " Sub regraph an.29(g)(3) has utabhshes a clear separation of been amended by addmg a proviso that funcuma to prnent any amarance of has been added at the end of l

subparagraph (0(4) directmg that if an the MRO rney reveal the quantitanon of a conthet of interest,includma apunns l

employee requests it, the collection site pereon shall provide the employee a a positive test result to the employer, the that the MRO has no responsabihty for l

i receipt for any personal belongmas.

emplo)ee, or the decisionmaker in a and is not supervaed by or the lawsuit, anes ance or other proceedmg supervisor of, any persons who have the l

Subparagraph (f)(8) now contama.

Initiated by or on behalf of the employee responsibility for the drug testing or language requinns that the collection site person provide to the inevidual a and ansing from a venfied positive drug quahty control opuadons of b sealed speciman container for purposes test (includmg a challenp by so laboraton.1.atu in % paragte A clanfying amendments hase been made P

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of giving the sampit.

h*n l eee oyee's d

to the 6entence be3mning 'Tha achon" Subparagraph (f)(10)(f) conarns the

" shy bladder" problem. The new certifica te, license, or other document)'

to say eat schon in qunh includes " conducting a medical language provides that if the individual Subparagraph (g)(6) has been is unable to provide to al of unne, the amended by adding langmage providmg interview with the individual" and may also include review of the in6vidual's collection aste person shall direct the that monthly reports shall not include me6 cal history or review of an) other indvidual to drink fluida and, after a data from which it is reasonably likelY relevant biomedical factors.

reasonable time, try again to provide a that information about individuals' teste Paragraph (c) has been amended by complete sample,in the case of a post.

can be readily inferred. If necessary in adding the words "for an individual'

' accident or reasonable cause test. the order to prevent disclosure of such data-after the words "posihve test resuh"in individual is not required to contmue the the ist> oratory shall not send a report the first sentence. New laoruage has procedure beyond eight hours from the until dets are euff ciently as:g+egated to been added followmg the hrst sentence.

start of the cellection procedure. For make such an inference unlikely. In any It es> s that the MRO shall make all other types of testing, another option is month in which a report is withheld for reasonable efforts to contact the provided, under which the employer is this reason, the laboretory would so employee directly. If the MRO is unabic

~

notified and 'he individualis scheduled inform the employer in wntmg.

to contact the employee directly after i

for an unannounced drug test in the near Section 40JJ Quchly Assurcnce end ma' king these effurts. the MRO would future (if an employee) or scheduled for Quohty Control. In subparagraph (d)(2) contact a represent tne of the employer a new preemplosment test (if an of this section. the blind tesung and request that the employer direct the I

apphcant, of course. the employer need requirements has e been simphfied and employee to contact the MRO as soon not hire en appbcant and the referral for the rates reduced. All employers, as possible. If the employer carmot get

)

further evaluation or test ng is not regardless of size, are covered. Each hold of the employee within a mandatory la the preemployment employer must submit three blind reasonable time, the employer may situation,if the em to hire the person).ployer does not want samples for every 100 employee place the employee on medicalless e or

)

lf the individual specimena submitted, to a maximum of temporary medically unqualif.'ed stat s.

j cannot produce a complete sample 100 blind samples per quarter. A DOT If the employer representative does within the eight bout period or at the agency could increase this maximum if contact the individual the MRO may subsequent test. the employer must tefer necessary, for extremely large declare the test a verified positive IL the individual to a physicir i for a employees or consortiums. For after five days have passed from a medical evaluation of whether the employees with fewer than 2000 covered docurnented contact instructing the problem is genuine or amounts to a employees. lower cost methods of employee to talk to the MRO. the refusal to take a drug test. Also in supplymg b!md samples are authorir.ed employee has not dorse so. To protect subparagraph (f)(10), new subparagraph by subparagraph (d)(4). Dimd testing employees, the MRO may reexamine the (ii) has been added, permitting but not need not begin until 180 days after verification if the employee documents requiring. the use of " split samples."It publication of the rule for employers that exigent circumstances prevented should be noted that the test of the with fewer than 2000 employees.

the employee from contactmg the MRO second part of a " split aample"la only Subparagraph (5) clarifies that a in time.

for presence of the drug (s) found consortium submits blind sampics on A new paragraph (b) has been added positive on the first test (i.e., the cutoff behalf ofits members.

after the end of this section concemms

)

)

,4 s

e

- - _ _ =. _ _ _.,

m-

\\

Federal Regleter / Val. 64, No. 330 / Pr6 day. December 1.1989 / Rulis and Regulatirne 49005

\\ nis rule will affect small entitiesfi the disclosure of other medical rulee or deliberate schemes to av d l

Information. It provides that the MRO

\\ compliance, e() the industnee covered by DOT 3

l may disc.lon medicalinformation i For example, one mejor indus operstmg edictmetration drug rule The learned as part of the testmg/

'soociation has empreened rn that bepc amou enuty impacts of est rule l

venhcotion process only if the MRO e am consorttume could be cre ted.

bate been considered as pan of e concludes that the information concerne

& ch a sham would allow m bers to opeistmg administrations' rule kmES-I use of medicat6ons or a medical el im that covered employee were nehtle to which these amend, ents condition that could result in the be tested, but httle or no i simg apply includes steps to reduce mall l

ernployee becoming medically wo d actually take place If e l

unquahfied under opphcable DOT rules De rtment were to determ e that such entity impacts in euch areas a or which otherwise could adversely ae m consortium existed. he inspections, submission of bh.d i

effect transportauon safety. The MRO Depa rnent would take all nforcement samples, and permanent log ochs.

would inform the employee, at the start actio esible under its r lations 4 h Dep e t e f+s of the venficauon intervnew, of the end. si e false statement or freudulent that 49 Part 40 wtll not ase e potential disclosure of such informstion. docum tation may be in olved. refer signify ni economic lenpa on a Section 40.35 Protection of em loyee approp te cases to Fed rollaw subets n al number of am entities records A sentence has been a[ded at enforce nt authorities r possible ne partment has co idered the the end of this section providing that the enminal

secution, federahs imphcotions this rule I

I laboratory shall disclose informahon Regulato Process Ma are under En tive Order 1 n. ne related to a positive drag test of an Departme t has determ' ed that this individual to the individual the

• !We la t a mapir le under rule docc i have suff tent federehsm employer or the decisionmaker in a Execuuve er 1

. Il y a signMcant imphcatio to warra the preparation lawsuit grievance or other formal rule under e Depa ent a Regulatory of a federal om esses ent. Federsham proceedmg initiated by or on behalf of Policies an Procedu es, atace it effects implication ofindivi ual operating the individual and ansma from a several pe ting e inistratione and admmistrati ne' rules are venfied positive drug test (includmg a

,jndus e

e discussed in ose emaking

,g ng i

challenge to a DOT agency e action documents.

concernmg an employee; medical these procedu a ere analyzed in the certificate, hcense, or other document).

regulatory eva at one or regulatory The mport an recordkeepmg Section 40.3s Use of DHHS.ccerified impact analyse f the operstma requirementa fe need in this administrabon

g. testing rules. ne regulation hav n submitted for laborotorses. The section number fo' this secuan has been changed from provisions of thi fmal rule which may Paperwork Red

'on Act approval to affect costa are r latively few. Use of a the Office of Me gement and Budget l 40.41 to i 40.39. The last two sentences sealed collectio ntainer/ specimen by the respectiv DOT operating of the section, referrms to the Dlit!S bottle is hkely i dd only marsmally to administrations connection with their certification standards set forth in program costs; a is already common own drug ruire, is le because it is the appendix A. have been deleted, as has practice,in an ca. Smce the use of a operating adrn is ration rules. rather the old appendix A itself.

..spht sample" e n mandatory, any than this rule, at actually impose the Enforcement Consideratione costs incurre by e loyers for this requirements o re lated parties.

purpose are sume to be voluntary.

flowever, the ih of the Secretary is g Although not directly as a part oftbia ne ehmmat n of th " batch mportmg" seekmg OMD pptc al under the iemaning. e numuer os persons ave requirement 9y res t in marginal Peperwork Re ucti Act for the oa da pl yers to revised form. F al Register notice of e pa ents gtest I

g prog ma. The six operstmg n[re sh uld be si 'ficant saving to will be publis ed wh n Paperwork Act

.dmi stration rules to whi part 40 larger ernp oyers beca e of reductions Approval is tained.

roced res apply are part f existmg in bhnd te ting require ients.The lasued tius th day of 'ovember two at statuto and regulatory stems.

marimum number of bl d samples to be Wa shmgion.

C.

General' they will be iforced in the submitte per quarter h e also been Samuel IL 6 r,

same way a the rest those systems.

lowered. e costs to e ployers should 3,,,m fy,'r

,,,,,po m for exempt FAAen Flfw A be reduc d proportionat ly. Costs will personnel in ect th equipment and also be wer because o projected Iht of Su jects in og C Part 40 secords of the rn they regulate. If reducts e in per sample ets (e g., to Contro ed substances they find rule v 1 'ons, they may S W 20 er sample, accor ng to initiate enforcem nt proceedirigs and inform tion from DIUIS.

Transpo abon.

impose civil pe es. The FAA or This saving will be offs. to some For th reasons set fo in the FilWA person el uld add review of degre. by addmg blind se iple preamb e, the Department f compliance th dru testing requi ments for smaller panies. But Transp rtation makes the Dowing requiremen to the ot er checks they theI rate of testing for th se amend ents in title 49,

' of Federal make of e loyers' co hance with com nies, added to the lo r cost Regul tions, part 40; safety rul s.

alte atives for blind sampic should 1.

e authority citation f 49 CFR Durin the initial stages f the me that individual employ will not part is revised to read as llows:

imple ntation of the Dep tmenre fac e heavy burden. For exa ple a drug sting rules, the Depa ent's king company w6th 50 cov red Au.

ty: es U.S.C. 102,301.s*

foc will be on assisting em oyers to dr vers (assuming a 50 percent andom 9 CPR part 40 is revised b read as E

co ply with the regulations. n6t on te tmg rate and the replaceme of half ggy s

p ahaing inadvertent or minor errors.

o its drivers per yest) would h ve to t the same time. the Department will ebbmit only three bhnd semples every not tolerate intentional violations of the two years et minimal cost.