ML20012E403

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Forwards,For Review,Draft NUREG, Fitness for Duty in Nuclear Power Industry:Responses to Implementation Questions, Due to CRGR Continuing Interest in fitness-for- Duty Issues at Power Reactors
ML20012E403
Person / Time
Issue date: 09/18/1989
From: Sniezek J
Office of Nuclear Reactor Regulation
To: Jordan E
NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
Shared Package
ML20011D109 List:
References
NUDOCS 9004050047
Download: ML20012E403 (60)


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September 18,,1989

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MEMORANDUM TOR:

Edward t. Jordan, Director s

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of Operational Data

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James H. Snierek, Deputy Director

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SUBJECT:

CRGR REVIEW OF RESPONSES TO QUEST 10hs ON TITNESS-FOR DUTY Enclosed is a draft NUREG, 'Titness for Duty in the Nuclear power Industry:

Responses to implementation Questions " Because of CRGR's continuing interest tn fitness for-duty issues at power reactors, we request CRGR review, s.

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Because of the need for licensees to have this information to cevelop their.

fitness for-duty program Jaolicy and impicmenting procedures, and to complete

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the training concerning tiose procedures prior to January 3,1990, we request thatCRGRreviewthedraftNUREGessoonas_pa$siQe.

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The responses are to questions asked by licensees and not to hypothetical situations. The responses reflect current Safeguards and inspection staff views on real world implementation issues, We believe that the NUREG would be the best m0ans of connunicating the NRC staff responses to the licensees. OGC

c and OE comments have been incorporated, We believe that the s terial enclosed with our request for CRGR review of s

the proposed fitness for-duty rule (see memorandum Murley to Jordan, dated a

March 8, 1988) and the records concerning CRGR meetings 131, 143, and 152 provide appropriate background information. No new impacts on'11censees result f rom tire clarification contained in the draft NUREG; in several cases the clarification reduces the burden.

ShouldtheCRGRneedadditionalinformation, please contact Loren Bush at 20944.

k Jame H. Snierek, Deputy rector Offi e of Nuclear Reactor Regulation

Enclosure:

Draf t NUREG (20 cys) cc: w/ enclosure J. Taylor, E00 i

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MEETING 170 FDC

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FITNESS 10R DUTY IN THE g?>

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L ABSTRACT P

t The Nuclear Regulatory Commission published a rule (10 CFR Part 26) concerning fitness for duty of commercial nuclear power plant workers on June 7,1989, in the Federal Register (54 FR 24468).

The rule focuses on methods for control-

. ling the use of substances that may affect the trustworthiness and performance t

of workers.

It provides for chemical testing, behavioral observation, employee awareness and education, and employee assistance programs as means for assuring fitness for duty.

This report responds to questions concerning the imple-mentation of the rule raised during the Edison Electric Institute's " Fitness-for-Duty Rule Implementation Workshop" during July 30 August 2,1989.

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responds to questions raised by licensees with the staff outside the workshop, l

i Although the responses have been prepared by the NRC staff, publication of this report does not constitute a written interpretation of the meaning of the rule, as provided by 10 CFR 26.4.

Only written interpretations by the General Counsel will be recognized to be binding upon the Commission.

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e TABLE OF CONTENTS e.

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1.0 INTRODUCTION

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2. 0 SCOPE AND IMPLEMENTATION OF 1NE RULE................

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P 3.0 WRITTEN POLICIES AND PROCEDURES

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L 4.0 TRAINING,............................

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5. 0 ALC0HOL AND DRUG TESTING......................

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e 6.0 MEDICAL REVIEW OFFICER.......................

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7. 0 CONTRACTOR / VENDOR PROGRAMS.

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8. 0 = INF REQUENT ACCESS.........................

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.9.0 EMPLOYEE ASSISTANCE PROGRAM.............

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10.0' MANAGEMENT ACTIONS AND SANCTIONS.................

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11. 0. REPORTING REQUIREMENTS......................

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12.0 MISCELLANEOUS...........................

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1.0 INTRODUCTION

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This document. responds to questions concerning the implementation of the Fitness-for-Duty Rule.(10 CFR Part 26, 54 FR 24468) which were raised:

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During the Edison Electric Institute's " Fitness-for-Duty l

i Rule Implementation Workshop", during July 30-August 2,1989 i

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During numerous telephone calls, visits and other t

contacts with the NRC staff by licensee personnel.

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Although the responses have been prepared by the NRC staff, publication of this f

I' report does not constitute a written interpretation of the meaning of the rule, as provided by 10 CFR 26.4.

Only written interpretations by the General Counsel will be recognized to be binding upon'the Commission.

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2.0 SCOPE AND IMPLEMEN1ATION OF.THE' RULE (3 :

2.1 What is the implementation date?

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Answer:

The correct implementation date is slanuary 3, 1990.. The correction was published in the Federal Register on August 11, 1989 (54 FR 33148).

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2. 2 Must all provisions of the rule be met by the implementation date?

I Answer:

Yes.

l 2.3 Must personnel who have no responsibilities affecting reactor safety and are not normally assigned duties under the scope of the rule be covered by a licensee's fitness-for-duty program simply because they report to the EOF or TSC? Emergency response personnel who report to the EOF /TSC and are not required to be badged (e.g., clerical or news team), are they subSct to the rule? Are licensees required to include non-essential EOF personnel (e.g., courier or fax personnel) in random testing?

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Answer:

If individuals are required, by name or position, to physically report, i.e., in person, to a licensee's EOF or TSC, the provisions of the L

rule apply (10 CFR 26.2(a)],

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,2.4 If an crganization has a contr:ct to provide support personnel, such'

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as guards or clerks to an EOF located off site, and the identities of the l

E individuals are not known until actually dispatched to the EOF, need these L

individuals be subject to the rule? How about licensee personnel from l

outside the " nuclear family" where a few people may be selected at the

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last moment to provide support services at the EOF or TSC?

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i ANSWER:

No.

They have not been identified as an individual by name or i

i' j-position to physically report, i.e., in person, to the EOF.

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2. 5 Please clarify the requirements applicable to state and local representatives who respond to a licensee's EOF and 150, 10 CFR 26.2 says i

that all persons reporting to a licensee's TSC or EOF are subject te the rule, whereas paragraph 4.2.5 of the Statment of Considerations (54 FR 24471) states that if the EOF or TSC are outside the protected area and the officials do not have responsibilities directly affecting reactor safety, they are not covered by the rule.

n i-Answer:

10 CFR 26.2(a) states that the provisions of the Fitness-for-Duty program must apply to all persons granted unescorted access to protected i

areas.

Therefore, the first te&c for applicability is whether the EOF or TSC art ocated within a protected area and whether unescorted access is going to be granted to these persons.

State and local representatives could be covered under this test.

The next test for applicability is whether the person is a licensee, vendor, or contractor employee required L

to physically report to the EOF cr TSC.

The state and local i

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,f representatives are not included uwer this test.

The discussion i'

F contained in paragraph 4.2.5 is intended to further c19tify the intent of I

the rule.

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2.6 What about corporate officials who respond to the EOF or TSC but have no responsibilities that could directly affect safety?

Answer:

If these officials are required to physically report to the EOF

.or TSC in decordance with a licensee's emergency plan and procedures, they

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must be covered by the Fitness-for-Duty program, j

i 2.7 Must behavioral observation baseline data (such as psychological.

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assessment and supervisory checklists) be implemented for those who don't

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i access.now but will come under the EOF /TSC requirements of 10 CFR 2o.;(a)?

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The rule does not require such action.

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3.1 What is the definition of an " emergency" as used in 26.20(e)(3) with

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respect to the use of " called-in" individuals who have consumed alcohol-I and whose BAC is above 0.04%?

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Answer:

" Emergency" would need to be detemined on a case-by-case r

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The licensee should consider such factors as the significance of j

the event and the urgency for the call-in in deciding if an " emergency" t'

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r 3.2 Is an employee subject to the 5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> abstinence requirements

[(26.20(a)(1)] while in an on-call status?

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Normally "on-call" for pr ans such as duty officers equates to

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li "on-duty," i.e., a working tour within the meaning o' 26.20(a)(2).-

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'4.1 Must all training be completed by January 3, 19907 F

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i Answer:- Yes, j

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4.2 If certain portions of the training requirement.. were completed prior to i

j the publication of the rule, need they be repeated?

Answer: No.

The training requirements are intended to ensure that everyone affected by the program, or responsible for any aspect of its I

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' implementation, understands the program and their role in its l

implementation.

Furthermore, that understanding must be reinforced at least once each 12 months.

Therefore, training or portions thereof need not be repeated prior to January 3, 1990, unless more than 12 months have I

elapsed since the completion of the previous training.

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4.3 Must the training of coin actor supervisors be completed within three l

months of initial assignment on site? What if the supervisor transfers L

t before the three months, will he avoid the training?

Is such training transferable between licensees?

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3 Answer: 10 CFR 26.22 requires that all supervisory pers;nnel, including contractors, be trained in supervisory aspects prior to assignment of 7

I duties covered by the rule or within three months of initial supervisory L

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assignment.

A contractor's supervisor who frequently transfers from one i

site to another must be trained prior to being granted unescorted access, i

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irrespective of the length of time on any given site.

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Any licensee, prior to granting unescorted access to a contractor l

supervisor, should assure that the required training has been completed within the schedules specified in 10 CFR 26.22.

l Licensees may review and accept a contractor's program under 10 CFR 26.23, l

and may choose to reserve for themselves certain portions of the program, i

such as training.

Credit for generic portions of the required training l

i may be transferred from one licensee to another; site specific training, such as company policy and procedures, are not transferable.

5 4.4 Should FFD training be included in normal G.E.T. and supervisory training, t

or should it be a stand alone class?

i Answer:

The licensee may choose any option that will result in each l

t person adequately understanding the program and their role in its implementation.

As stated by several attendees at the EEI Workshop, by i

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visibility, students could Setter focus on the subject, and retention of L

the knowledge would be enhanced, h

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4.5 !s testing required?

u Answer:

Licensees are expected to assure that the training has achieved the desired results.

This is usually achieved through testing, f

4.6 Are there three different types of training required, i.e., employee, supervisor, and escorts?

Answer:

Yes.

5 I-4.7 What would be the difference between supervisor and escort training?

Answer:

Since an escort has only a short-term relationship with the people being escorted, the escort training should emphasize the detection 1

of obvious current signs of alcohol or drug use.

In addition to that

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skill, the supervisor would be looking for long-term patterns, such as attendance and degradation in work performance. The differences are spelled out in 10 CFR 26.22.

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'4.8 What will satisfy the requireeents on training supervisors in drug i

awareness behavioral observation?

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Any method that will ensure that the supervisory personnel p

understand the aspects of their responsibilities as described in 10 CFR b.

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4.9 Who is a supervisor? Would it include a person designated as " team t

leader," " lead person," or " gang boss" for a few days? How about vendor j

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on site for a few hours?

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Answer:

The determination of who is a supervisor is up to each licensee.

Such determination should be based upon such factors as who is responsible l

for the behavioral observation of the person, who is in charge of the

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work, and who is responsible for evaluating the performance of the work.-

4.10 Who would be responsible for behavioral observation of those persons whose

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supervisor is not badged and, therefore, not on site? Examples are i

contractors and INPO.

..I Answer: Whoever is responsible for supervising the completion of the i

work.

In the case of INPO, the team leader should be responsible for the

'l members of his team, otherwise an appropriate licensee official should be -

designated as responsible, j

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5.0 ALCOHOL AND DRUG TESTING L

5.1 Does NRC's Appendix A preempt the HHS Guidelines?

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h Answer: The NRC sees no conflict.

The HHS Guidelines apply to l

I' federal agencies and to the testing laboratories.

The NRC's Appendix A applies to NRC licensees; the provisions of Appendix A relating to the

. laboratories should be contained in licensee contracts with the testing laboratories.

5. 2 Can a non-certified contract laboratory be used for preliminary screening?

w; Answer:

Although the rule does not prohibit such a practice, this

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approach should not be used.

The staff of the National Institute on Drug

. Abuse had strong reservations about the rule permitting licensees to conduct preliminary screening.

The approach in question would lose some t'

of the safeguards built into the rule.

For example, more people will be handling a specimen, a second courier run would be needed, and additienal 4

time would be required to process the specimens.

In addition, should there be a legal proceeding, everyone who has handled the specimen in l'

question can be summoned to appear. The additional handling could thereby jeopardize the case.

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1 5.3 What should come first in f:r-cause test situati:ns, refcrral to EAP for assessment or a test?

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Generally, a test would preceed assessment.

The actions to be r

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taken and their timing would depend upon the situation.

For example:

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l A person that appears to be impaired would normally be physically

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, examined by a physician as soon as possible and then tested.

Enrollment in the EAP would follow.

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A prarson observed while using illegal drugs may need to be tested a few times, each test a few hours after the previous test, to enable j

the drug (s) or metabolites to reach the urine.

If the drug (s) can be confiscated, they should be tested.

Since 10 CFR 26.27(b)(3) expects s

immediate removal for such acts, referral to the EAP may not apply, p:

A person involved in an accident described in 26;24(a)(3) or alleged to be using alcohol or drugs should be tested as soon as possible.

Referral to an EAP would probably depend on the results of the test.

5.4 Will the NRC have a loose or strict interpretation of af ter-accident testing?

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The NRC expects licensee management to exercise prudent judgement as to whether a test is appropriate in each case, using the guidelines L

contained in the rule.

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5.5 Must results of pre-access tests conducted in accordance.with 10 CFR 26.24(a)(1) be obtained before unescorted access is granted?

t Answer:

Yes.

A negative test result must be obtained prior to granting unescorted access unless the individual is excluded from the rule by 10 l

l CFR 26.2(a) or previously tested under a program formally reviewed and l

approved by the licensee under the provisions of 10 CFR 26.23(a).

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e contractors or state personnel tested under NRC programs do not require l

pre-access tests by the licensee.

5. 6 What constitutes an acceptable approach to selecting persons for random I

testing? What is not acceptable?

i Answer:

10 CFR 26.24(a)(2) permits the licensee to have discretion as to j

how the random selection is administered and only requires that a person completing a test is immediately eligible for another unannounced test.

f The " Medical Review Officer Manual," published by the Department of Health I

I and Human Services suggests that random sampling procedures should permit l

1 no " safe periods" for any employee.

"Each work day should present each employee with a new opportunity of having to produce a sample, with the f

[L odds equal to all employees on each new day, regardless of samples f

c previously produced by any of them," A common acceptable approach is to l

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o l-Li utilize a computer to randomly sel:ct a number cf pers:ns for testing each s

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1 day.

An acceptable approach has been developed by the Southern California t

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Edison Company and is referred to by SCE as compound random sampling.

This approach utilizes the statistical phenomena that in a given t

i population being tested at an annual rate of 100%, approximately 67% of

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the people will be tested at least once during the year, which also means t

that 33% would not be tested.

As time goes on, the population that has m

not been tested is placed into a separate category where they are randomly

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selected, separate and apart from those who have been tested.

As the I

people in the untested category are tested, they are placed in the batic 0001 of people who have been tested and are still being selected at a 67%

probability.

Similar approaches were discussed in the Federal Register with the proposed rule at 53 FR 36810.

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Any scheme that would contain unfairness in the selection or provides

" safe periods" would not be acceptable.

An example would be one that would select people for random testing as they enter the facility. The reason why this wouldn't be acceptable is that not all persons would have i

equal probabilities of being sei*ued.

For example, some people would enter the facility several times each day with opportunities for selection each time they enter.

Other persons might enter the facility only two or

-f three times a year; the probabilities of being selected would be quite t

I remote for them.

More importantly these infrequent entrants would not be i

1 vulnerable to random testing during the period they did not enter the site i

,i and, therefore, the deterrent value of random testing would not exist for them.

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5. 7 Must collection of a specimen be observed everytime the circumstances F

l constituting reason to believe [as described in Appendix A, Section i.

2.4(1)] occur, such as when the specific gravity is low or upon return to l

l work after rehabilitation? Or, may there be discretion or judgement on i

the part of the collection personnel as to whether or not they really do p

have a reason to believe? For example, would be the individual or who is taking a diuretic and consuming considerable quantities of liquids need to i.

be observed?

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. Answer:

The observation of the collection of a urine specimen is required whenever there is a reason to believe that there may be an attempt to alter or substitute the specimen.

The rule provides examples of what would constitute grounds for reason to believe, to include return to work after evaluation and/or treatment for a confirmed positive test result.

Prudent judgment by the medical staff is expected.

The existence of a low specific gravity accompanied by plausible explanation would not normally cause one to believe there is an attempt to alter or substitute.

The prudent course of action is to observe in questionable cases.

5.8 Are witnessed urinations required during a rehabilitation program?

r Answer:

Direct observation of the collection of specimens during a rehabilitet %n program is required by Section 2.4(f)(4).

L Direct observation is required for the test immediately prior to return to work, but is not required for the three years of follow-up testing i

after the employee has been returned to work, unless the medical staff determines that such observation is appropriate.

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'$ 9 Must an immunoassay test be tsed, as required by Secten 2.7(e) of I

Appendix A, for testing additional drugs added under the provisions of 26.24(c)?

I Answer:

An immunoassay shall be used wherever appropriate.

Should a i

l licensee wish to add a drug tu its testing protocol for which there is no immunoassay test, then the licensee should discuss what is the best i

screening test with its contract laboratory.

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.l 5.10 Whenever there is a suspicion that a specimen had been adulterated or i

tampered, must there be a same gender observer for the witnessed specimen?

l Answer:

Yes, as required by Section 2.4(b) of Appendix A.

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5.11 A few licensees have expressed an interest in requiring a blood test to confirm the results of breath analysis for alcohol or whenever a urine sp Nimen for drug testing cannot be obtained. Would the NRC accept such

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proposals?

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l Answer:

No.

Requiring an employee to provide blood on demand by the l

t employer should not be adopted.

The-drawing of~ blood is judged to be

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. invasive and there are other acceptable approaches.

Such a requirement

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may be subject to legal challenges.

Providing the employee an option to provide blood for testing on a consensual basis is acceptable.

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t 5.12 Can utilities continue their procedure for collecting and testing a second f

r specimen 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the first specimen was confirmed positive; both

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specimens would have to be tested positive before the results were l

declared a confirmed positive?

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Answer:

No. Licensees are required, among other action, to conduct follow-up testing on retained employees once the first confirmed positive is obtained.

The initial follow-up test could occur immediately upon determination of a confirmed positive test.

The licensee is expected to do further testing and examining before the employee is returned to work; that testing can occur on several dif ferent occasions. The practice of d'

using a second test result to determine if the results of the first test p

are indeed confirmed would not be permitted.

This procedure, because of elapsed time between collections, would focus on addicts and probably omit most other users from detection.

5.13 Must all results of a batch (of specimens being tested) be reported together as required by Section 2.7(g) of Appendix A, or can negative test results for pre-access tests be reported separately when positive results are pending final determination?

Answer:

The test results for all specimens submitted to a certified laboratory at the same time must be repnrted back to the Medical Review Officer at the same time.

This language is also contained in Section 2.4(g) of the HHS Guidelines and is intended to ensure that admimistrative i

errors in the laboratory are minimized.

Negative screening results of

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pre-access tests obtained by licensees prior to submitting presumed positive specimens to a certified laboratory may be reported immediately.

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5.14 A freque:.t complaint cf testing laboratories is that they would lose their i

HHS certification if, (1) they test for additional drugs; or (2) use lower l

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cut-off levels. Any truth to their claim?

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3 Ajswer:

Subpart C, of the HHS Guidelines indicates that certified laboratories must clearly inform non-federal clients of their procedures, p

That requirement indicates that HHS certified laboratories can perform j

other work outside the scope of their certified work for federal agency

programs, This answer has been confirmed as correct by NIDA.

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5.15 Does the term "new drug testing program" in Section 2.8(e)(2) apply to laboratories which were under contract to the licensee before the rule?

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Answer:

Yes.

Licensees are expected to provide blind performance test L

t specimens to assure that the laboratory work is accurate.

If such blind

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specimens were submitted in the quantities and time periods specified, I

covered the drugs and cut-off levels used after implementation of the rule, and the laboratory was certified by HHS during that time, then the licensee can take credit for completing the inital 90-day period of this f

quality assurance procedure.

(See related discussion at item 10.5.6 of r

NUREG-1354, " Fitness for Duty in the Nuclear Power Industry: Responses to Public Comments).

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5.16 Are there reasonable limits concerning who are the specimen couriers that l

must meet the honesty and integrity standards of Section 2.3 in the NRC j

l Guidelines? Would the standards apply to contract couriers who may change l

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f daily? How about Postal Service employees, Federal Express couriers, and t

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pilots and crews of aircraft?

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Answer:

The intent of the rule is to prevent the integrity of the testing t

program from being subverted.

The more remote the possibility of a l

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personal relationship existing between the person whose specimen is being j

processed for testing and any person doing the procecsing, the less likely

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that deliberate acts to subvert the integrity of the test would occur.

Therefore, the licensee should have reasonable assurance that couriers employed to pick up and deliver specimens meet normal expectations of

1 honesty and integrity.

Licensees could assure themselves that a contract courier service takes recsontble precautions, such as bonding of employees i

i (based on some appropriate standard other than payment of a fee).

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Postal Service may be used.

Postal Service employees are not covered by the rule.

I 5.17 Why must alcohol breath analysis equipment meet state standards, as I

t required by Section 2.7(o)(3)?

l Answer:

Since the states-have been developing and enforcing statutes for i

i dealing with drunk driving, the inclusion of the " applicable state

[

.i statutes" provision for testing equipment in the rule should result in a l

I more credible test result.

l I

f l.

j 5-9 i

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$ 18 What vendors can provide spiked samp1:s?

s - -

3 Answer:

for information, licensees should contact the National. Institute on Drug Abuse at (301) 443 6780.

Sources that have been suggested by NIDA include:

Research Triangle Institute 3040 Cornwall Road Research Triangle, North Carolina 27709

Contact:

Ken Davis (919) 541 6709 i

000 - Research, Inc.

164 Conduit Street l

Annapolis, Maryland 21401-2513

Contact:

Dr. Robert W111ette (301) 263-5749 I

i Bio.- RAD Laboratory-l 3700 East Miraloma Ave.

Annaheim, California 92806

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Contact:

Robyn Hawkins or Elizabeth Chardon

.{

(800) 854-6737 i

Hycor Medical

'I

' Garden Grove, California

Contact:

Patricia Pick (714) 546-9581 5-10 1

i L

5.19 Can ifconsees use specimens that have been tested negative for the 804 o

L blank blind performance test samples that must be submitted under the f.

1 h

provisions of Section 2,8(e)(3)?

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ANSWER: The blank specimen must be certified to contain no drug, l

Specimens must not be used if they contain drugs below the cut off levels, p

or any drugs that could cross react ar.J mimic the drugs for which the test i

is being conducted. The propriety of a laboratory providing its clients a

i with blind samples to test its proficiency could be questioned.

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5-11 l.

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L' 6.0 MEDICAL REVIEW OFFICER i

6.1 Can a physician's assistant function as the Medical Review Officer (MRO)?

Answer:

No.

Section 2.9(b) of the NRC Guidelines requires that the Medical Review Officer be a licensed physician with knowledge of substance I

abuse disorders.

This language is also contained in the HHS Guidelines.

A physician's assistant would not be able to perform as Medical Review f

Officer unless the physician's assistant was a licensed physician and had f

l knowledge of substance abuse disorders.

~

6.2 Under the appeals permitted under Section 26.28, who is qualified to

).

review.the Medical Review Officer's determination?

l Answer:

The rule permits an impartial internal management review.

This j

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could be a board of impartial managers.

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k 6.3 When does the 10-day clock begin for the Medical Review Officer when on-site prescreening is used? What if the Medical Review Officer cannot l

t contact the individual within the 10-day period?

i Answer:

Section 2.4(e) requires that the MRO review be completed and j

licensee management notified within 10 days of the initial presumptive i

positive screening test.

The 10-day reporting requirement would not be l

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applicable if the person is not worktag within the protected area and is

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not available for interview by the Medical Review Officer.

The NRC

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expects that reasonable efforts to tontact the individual at his or her

(

residence would be taken.

In such a case, any interviews and the MRO's b

determination should be completed as soon after the individual is available as is possible (see related discussion at 6.12).

Of course, any individual who is impaired or whose fitness may be questionable must be removed from unescorted access status under the provisions of 10 CFR 26.27 (b)(1).

If the sample is lost, the report te licensee man 6gement would be based on available information.

I' 6.4 Who may tf.e results of initial screening tests be shared with?

Answer:

Section 26.24(d) states that the access to the results of a l

preliminary test must be limited to the licensee testing staff, the Medical Review Officer, the Fitness-for-Duty program manager, and the i

Employees Assistance Program staff, when appropriate.

The results of the initial screening test at the certified laboratory may be provided to the MRO only af ter confirmatory tests and laboratory reviews have been completed [Section 2.7(g)].

Negative results of initial screening tests may be provided to management along with MRO determined negatives and confirmed positives.

Negative results of pre-access tests obtained by licensees prior to submittal of presumed positive specimens to a certified laboratory may be provided immediately.

6.5 If a group of persons are being processed to be h:ced, can management be informed of negative results of pre-employment screening tests if anyone 4

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in the group of applicants are presumptive positive?

are pre-access, random or follow-up?

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Answer:

10 CFR Part 26 does'not cover pre employment testing by.a q

1.-

4 licensee.

Negative results of pre-access and follow-up tests obtained by n-?,

the licenseo prior to submittal of presumed positives to a certified laboratory may be reported immediately.

Results.of random tests must j.

.awatt completion of laboratory tests and HR0 evaluation, w

Ip 6.6 May negative test results from the HHS cartified lab be provided directly to the Fitness-for-Duty Program Adminir,trater?

A_nswer:

Section 2.7(g) of the NPC Suidelines requires that the test results be reported to the l'icensee's Medical Review Officer.

This language is also contained in the HHS. Guidelines and is' intended to protect theLidentity of those who may have tested positive but not yet' been determined as' positive by the MRO.

L l

6. 7 Must the' medical review officer review both positive and negative tests results?

e Answer: Although' the primary responsibility of the Medical Review Officer R

j

.is to review and interpret positive test results obtained through the i'

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F 4

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o testing program, the Medical Review Officer does have a role in reviewing the performance of the licensee's screening facility and the HHS-certified l,

l.

laboratory and making judgement about the overall effectiveness of the fitness-for duty program.

Therefore, the Medical Review Officer should review negative test results, particularly those that fall just short of the cut-off levels, to determine if there were any laboratory errors or whether there is a problem that needs to be addressed either with the employee or with the program itself.

" ~

6.8 Can the Medical Review Officer initiate any action if results are below the cut-of f levels? That is, can the MRO recommend the suspension of an enployee based upon an unconfirmed positive?

Answer:

The Medical Review Officer can take appropriate action i

based upon his judgement.

However, that would be done without the protection of the rule.

In the example provided, it is recommended that the individual be referred to the Employee Assistance Program for review and counseling.

Referral to licensee management for imposition of t

sanctionr. would be considered inappropriate.

6.9 At what point is a test considered a confirmed positive?

i Antwer: Whon the Nedical Review Officer has made a final determination that the results have been confirmed as positive.

This would occur after he has reviewed the laboratory report, provided the individual an opportunity to discuss the test results, and completed any other matters i

i 6-4

,C

C t

t that he deemed appropriate befcre the determination is made.

This does not p6 eclude the Medical Review Officer from making an early determination based upon other information.

On the other hand, if there is a logical or legitimate explanation provided early on for the drug or drug metabolite being in the individual's urine specimen, then the Medical Review Officer can determine that the test results are negative.

[

6.10 Does the requirement to examine clinical evidence mean that there must be f

a face-to-face encounter between the Medical Review Officer and the t

employee whose laboratory results indicate positive? Can a Medical Review Officer be located some considerable distance from the site?

[

i Answer:

The question relates to the requirement stated in Section 2.9(d) f in the NRC Guidelines, which requires that'the Medical Review Officer determine whether there is clinical evidence of opiate abuse.

To meet l

this requirement, the Medical Review Officer would need to look for needle tracks,' or behavioral and psychological signs of acute opiate intoxication or withdrawal.

A detailed explanation of this process is described in the Medical Review Officer Manual. Obviously, such a requirement could only be accomplished with a face-to-face examination by the Medical Review 1

Officer.

In some cases, the MRO'could discuss the test results by telephone with the individual, provided suitable precautions are taken to confirm identity and protect the information as required by 10 CFR 26.29(a) and (b).

l l

l 4

6-5 9

p[q7q ff H

j H-6.11 Can a Medical Review Officer be someone from the testing laboratory?

m.

I Answer:

Using someone from the testing laboratory to serve as the Medical a-Review Officer would probably be a conflict of interest because the l

Medical, Review Officer is expected to make judgements concerning the perfermance of the laboratory, request that the laboratory repeat tests 4

that he might question the scientific adequacy and so forth.

Therefore, using a person from the ter, ting laboratory as the Medical Review Officer would bd contrary to the intent of both the NRC and the HHS Guidelines.

6.12 Does the Medical Review Officer have to discuss the test results with the individual prior to determining that the results are positive?

Answer:

No.

Section 2.9(c) of the NRC Guidelines require that the Medical Review Officer shall give the individual an opportunity to discuss

'the test results.

If the individual is not aw. lable, any interviews should be completed as soon after the individt.B :s available as is possible (see related discussion at 6.3).

6.13 Since an Medical Review Officer will give the individual an opportunity to discuss the test results prior to making his final decision under the provisions of 2.9(c), can management also be notified at that time so that the individual's access can be suspended?

Answer:

Section 2.9(c) of the NRC Guidelines requires that licensee management not be notified until the Medical Review Officer has determined r-6-6

t

- o L

L, that the laboratory test result has been confirmed as positive.

This L

language is also contained in Section 2.8(c) of the HHS Guidelines.

There was a lengthy discussion on this issue at the EEI workshop.

A number of y

i the attendees strongly expressed their opinion that they should remove an r

b individual from safety-related responsibilities at the first indication b

that the individual has a substance abuse problem.

There were also several comments that psychoactive drugs, such as PCP and LSD, have no legitimate medical use and there is a high potential for unpredictable psychosis and agitation, therefore, any person using those drugs clearly constitutes a serious potential hazard to safety; such persons should be promptly removed irrespective of what the NRC and the HHS Guidelines state.

These remarks have been repeated several times in other forms to the NRC staff. The Commission's decision to require that management not have access to unconfimred test result.s was based upon establishing the proper balance between individual rights and the interests of public safety.

That issue was addressed by the Department of Health and Human Services in the responses the public comments to the HHS Guidelines (53 FR 11974).

In that Federal Register Notice, HHS suggested that the agency

" develop a mechanism to expedite the review process or allow the Medical Review Officer to require a review of the individual's general fitness to

- i-continue performing a specific function." The response by HHS goes on to say that, " circumventing the review system would abridge necessary protections for employees and could result in prejudging an individual employee's case."

[

6-7 c

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6.14 If an employee is arrested in possession of drugs, our personnel policies i

dictate that the individual would be terminated immediately, without waiting for a conviction.

On the other hand, if we have a presumptive positive test for drugs,.then we would have to wait several days maybe a l

i.

week or longer until that information is confirmed before we can take action.

We regard that as a glaring inconsistency and we should not have i

to live with it.

j Answer:

The rule expects that the Medical Review Officer make a determination as to whether or not the results are positive and that there be no action taken to jeopardize the individual's employment until the determination is made.

The decision to adopt this course of action as'a prudent balance between individual rights and interest of public safety.

The NRC makes no connection between the results of the urine test and current impairment, and assumes there are some undetected users.

The issue is the trustworthiness and the reliability of the employee.

In the case where the employee has been arrested, the licensee should look into the matter, assure that the facts are as reported, and then take action in accordance with personnel policies which should cover that kind of event.

Of course, a licensee or contractor employee exhibiting signs of impairment should immediately be removed from unescorted access status, i

irrespective of the status of testing.

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.j l6.15 Are the requirements of'2.7(g)(4) and (5)'in conflict?- Section 2.7(g)(4) l p

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permits;the laboratory to transmit results to the Medical Review Officer j

fr by various electronic means as long as the confidentiality of the j

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l information'is~ protected.

Section 2.7(g)(5) says that the laboratory n

i ha shall forward the original chain-of-custody form attached to which shall

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4 be a copy of the' test report..

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a Answer: _The NRC regards these as separate but compatible requirements.

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q Section 2.7(g)(5) can be satisfied after g(4) has been accomplished.

f[n Section 2.7 (g)(4) would provide the licensee with a rapid means of

' obtaining the information, and Section.2.7(g)(5) is the procedure for the~

j officia1' formal notification and contains evidence that would need to be f

[

retained for any legal proceeding.

r 6.16 Does the Medical; Review Officer pe u nally have to see the chain-

^.i of-custody form?

t 1

Answer: ~ Yes. - Section 2.7(g)(5)l requires that the. laboratory send the h

original chain-of-custody form to the Medical Review Officer. ' The Medical

).

[

Review Officer, in determining that any test result is positive, should

.i e

assure himself that all relevant evidence bearing on that case is obtained

' and protected so that proper disposition of the case through any legal proceeding is possible.

However, a determination that a confirmed positive test has been made can be based on electronic transmittal of the test informetion.

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6.17 If the Medical Review Officer decides to respond to an: individual's k.,

m l-c' request'to'have a' specimen retested.does the specimen have to be tested h '.o -

by a different' laboratory?

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IL Answer:

No.

Section 2.7(g) of the NRC Guidelines permits re-analysis at

]-

h the same laboratory or at'an alternate laboratory, as determined by the j

4 Medical Review Officer.

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'6.18 If you split a sample, do you have to use a different laboratory?

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.I Answer:

This'is an option available to the Medical Review Officer as l

providedunder:Section2.7(j).

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7.0 CONTRACTOR / VENDOR PROGRAMS L

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p 7.1 What requirements must be met so that there can be reciprocity among licensees with respect to contractors and vendors?

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Answer:

All licensees using a particular contractor or vendor must review L1

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and approve the contractor / vendor program under the provisions of 10 CFR 26.23(a).

Licensees-may accept an audit of such program by another-w, h ',

' licensee under the provisions of 10 CFR 26.80.

e

[

7.2-Can~1icensees; accept other programs, such as those administered by other licensees, state and local govern:nents and the Department of Energy under t

the provisions of 10 CFR 26.23? What if the other program does not-include' alcohol testing?

Answer:

Licensees may reviuw and approve any program that meets the overall intent of 10 CFR Part 26 and includes, as a minimum, employee-awareness training and chemical testing, including random testing.

A program that does not include alcohol testing would not meet the intent of ~

c the rule, and would not be acceptable on its own.

l 9

7.3 Can a licensee accept parts of a contractor or vendor program? For example, can a licensee collect specimens for testing of contractor 1,.

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employees under a contractor's program reviewed and approved by the licensee under the provisions.'of 26.237 l

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Answer:

Yes.

The licensee can substitute, supplement,'or duplicate any portion of a program that. it deems appropriate for achieving the goals of

.t the' rule.

For example, pre-access and random testing for alcohol and drugs F

could be conducted by licensees and the other portions of contractor, i:

state and local-or DOE programs could be accomplished through the reviewed.

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and approved program.

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'7. 4.

Do contractors, even small ones such as grass cutters and building cleaners, have to have an EAP?

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Answer:

Only if the licensee has reviewed and accepted the contractor's program-under the provisions of 26.23.

If the licensee does not accept o.

the. contractor's program, or the contractor does not have a program (which I

p is probably the usual situation with a small contractor), the contractor

+

will come under the licensee's fitness-for-duty program. Where the contractor is being covered by the' licensee's program, the licensee is not required to provide the contractor with an Employee Assistance Program.

1

7. 5 If a person, who is under the care of a contractor's EAP, is sent to a licensee's site, how is that care continued and how is the patient's I

progress reported back to his employer to ensure that the person is a

continuing the treatment and receiving the counseling that is appropriate?

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Answer:: That is a matter is left t, the discretion of each licensee.- 'It

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would be appropriate for those kinds of situations to be addret wo through i

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a provision of the contract.

The contractor has an obligation under l

.j 26,23(a)(2) to notify the licensee of such a situation and the licaasee p-o must determine that the particular circumstances are acceptable.

There L

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are three obvious courses of action: (i) tell the contractor employee that he may not work at the site, (ii) the contractor must find some kind of an

['

EAP service that is available locally, or (iii) agree to' provide Employee

]

t Assistance Program services to support the contractor's program.

7.6 How many licensees will not permit any contractors to *aturn to the plant after the first positive test?

]

Answer: A survey of the audience was conducted.

There was an' k

overwhelming affirmati w response to the att0stion.

S'ith'one or'two exceptions, contractors would be barret from the plant as a result of the l

first positive test.

v 7.7 A contractor's program was reviewed and approved by a licensee, Must both the licensee and the contractor audit the contractor's program?-

+

I Answer:

Yes, i

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8.0 INFREQUENT ACCESS hs L

8.1 Is pre-access testing required each time a contractor or vendor employee t

3

' starts working at a site?

t answer:

If the contractor / vendor has a program that has been reviewed and accepted by more than one licensee under the prod sions of 26.23, then any employees of the contractor / vendor may transfer between such licensee's i

facilities without having to repeat the pre-access test, provided that all y

provisions of the rule have otherwise been met.

For example, a pre-access test was administered prior'to the initial granting of unescorted access at the first facility'and the employee was continuously covered ty both a l

behavioral observction program and a random testing program while he l

worked for and transferred between the two licensees.

(A' reasonably short 3

t

ariod of time to accomplish tiie transfer need not be included.)

i F

Contractor employees not covered by a program reviewed and approved by a licensee under the provisions of 10 CFR 26.23 should be pre-access tested.

"~

Any pre access or random test conducted'under a program covered by the

,r 7'

rule, completed within 60 days prior to assignment to activities covered by Part 26 at the previous site will satisfy 26.24(a)(1).

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8.2 May licensees accept another licensee's fitness-for-duty program under a -

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" reciprocity agreement" for persons who may need to visit another site?

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s' Answer:

Yes.

The " visitor" must be continuously covered by the

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behavioral observation and random testing provisions of_ either or both of j

i the licensee programs.

(See related discussions at 7.1, 7.2, and 8.1) i 8.3 What testing and access procedures are acceptable for utility personnel, l

such as maintenance perst.nnel, who may need unescorted access to the n

t L

nuclear facility, but are normally dispersed throughout the licensee's j

system and may not be working in a location where they can be tested? Can-

.the licensee suspend their access between on-site assignments pending pre-access testing on each return to the site without other administrative j

requirements, such as inquiries, training, etc?

l t

. Answer:

The licensee has discretion as to how it wishes to administer the program in the case in question. The basic options are: (i) to retain the personnel in the fitness-for-duty program which means that they be subjected to refresher training, rt.ndom testing, etc., or (ii)-to' remove them from the program and ensure that they have been tested within 60 days prior to each time they are returned to the program (this option would

[

also require that the employee be subject to all provisions of the-rule as a "new" employee, including training, upon their return). For individuals L

in remote locations who are retained in the FFD program, the licensee has the option of having these people report to a temporary collection site or having them return to a permanently established collection site.

n l'

4 8-2

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w 6s 8.4L.ls a contractor employee subject to pre-access screening at different sites, if the last screening was within 60 days?

1 i

Answer: ~ No.

Any pre-access or random test administered within the previous 60 days alder a progrca meeting the requirements of Part 26 would meet the requirement.

Also, if the contractor has a fitness-for-duty-program reviewed and accepted under the provisions of 10 CFR 26.23 by each of the affected licensees, the pre-access screening would apply only uoon initial access under a program covered by the rule.

8. 5 Need suitable inquiries be conducted for (i) those who are not under a

' fitness-for-duty program for an extended period; (ii) contractors who are -

on site once per year, and (iii) persons granted unescorted' access to any nuclear site'during the past year?

Answer:- Suc'h inqu'iries need not be conducted if the contractor employee is continuously covered by a fitness-for-duty program in conformance with the. rule.

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.i 9.0 EMPLOYEE ASSISTANCE PROGRAM j

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9.1 What constitutes an effective Fitness-for-Duty program? How do you I

measure'an' Employee Assistance Program?

j i

lm,

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i

' Answer:

The Consission has tasked the NRC staff to closely monitor the

' implementation of the rule and revisit the need for changes within 18 f

months following the implementation date. What constitutes an effective program, and what^are appropriate program performance indicators are being j

i considered as part of that effort.

Industry may wish to explore methods of measuring an EAP, which is not part of the NRC staff effort.

l 1

[

9. 2 Must licensee management and the NRC be notified when a person self refers to the EAP and has drugs or alcohol in his system?

Answer:

Licensee management would not be notified unless the medical personnel determined that the person constituted a hazard to himself or to others.- As for reportability to the NRC, self-referrals are not reportable ur. der Section 26.73.

NUMARC did not include'such information on their data collection form, however, the NRC may collect EtF program

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performance data during inspections.

(See answer to 9.6.)

l 9.3 Does the requirement for supervisory procedures to initiate appropriate y y; corrective action [10 CFR 26.22(a)(5)] include referral for voluntary r

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assistance?

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Answer:' No.

Once'a supervisor has confronted a troubled employee and.

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' referred the individual'for assessment, the protections afforded an i

cc employee who self-refers should not be provided to the individual referred' j

.by.the supervisor.

I

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9.4' What follow-up is required for employees who~self referred on a substance

y use problem?

l W

i Answer:

The nature, character and frequency of the follevup should be

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determined b'y the doctor who is treating the patient.

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,1 9.5 What is a safety' hazard for purposes of reporting EAP self-referrals to

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n management?

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Answer: That would be up to the judgement of the person evaluating the-l c

' patient.

The evaluator should have ceneral knowledge of nuclear potter -

4 plant work demands, normally based on discussions with licensee

.l management.

~

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F' 9.6.How much documentation on EAPs should be available for NRC inspections?

i 6

j 5

i Answer:

The NRC would be interested in data concerning program l

utilization and measures for protecting confidentiality.

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C 10.0 MANAGEMENT ACTIONS AND SANCTIONS i

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10.1 For those employees who have tested positive before the rule was s

published, will their records be wiped clean on January 3,1990 or will a j

.past test failure count under the rule?

[

['

[

t Answer:

After January 3, 1990, the next positive test would be t

p considered the first positive test under the provisions of the rule.

The NRC would certainly expect the licensees to take action in accordance with j

the provisions-of the rule, and the rule permits licensees to-take more

{

stringent action than specified in Section 26.27.

Therefore, there is 7

sufficient flexibility in the rule so that the vast majori'y of li. m ees

{

t who indicated during the work-shop that they would consider pa!t test i

results as if they were under the rule would be able to c so.

However,

-(.;

such actions would be without the protection of the rule (as are current i

h actions).

-l 10.2 Please clarify the term suitable inquiries that are conducted over the previous 3-and 5 year time periods?

f Answer:

The question relates to.the definition of suitable inquiries

{

which requires that licensees must, on a best effort basis, deter:he whether or not that there is a history of alcohol or drug problean, over t

the previous 5 years, but no case less than 3.

Licensees must make a h.

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0 [f f best effort-to obtain the information.

Should the information not be t

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4 f' 07 obtainable, then licensees must consider whether or not they should bring:

L the person on board.

There are situations wtere licensees may not be able L

to'get complete information, particularly in cases where applicants are i

coming from a foreign country.

In those cases, the licensees would have to determine what is appropriate and document their efforts to obtain the

'i

-information.

In all cases, licensees must make a best effort to determine whether the person is reliable and trustworthy and can be granted an L

escorted access.

I b,

'10.3 When a " suitable inquiry" is made to a licensee, what information should be disclosed?

e e

Answer:

Section 26.27(a) requires that the licensee determine if the applicant has ever been (i) tested positive for drugs or ever used alcohol' resulting in on-duty impairment, (ii) treated for substance abuse except for self referral, (iii) removed because of a fitness-for-duty problem, and (iv) denied unescorted access.

Obviously, to respond to such an inquiry, licensees should have a records system which contains that kind 1

of information (see 10 CFC 26.29 and 26.71).

J 10.4 What if the licensee's legal department determines that disclosure of such information violates their state law?

I Answer:

The Statement of Considerations, Section 38.2.3 at 54 FR 24489

?

states that Federal law, i.e., the Atomic Energy Act and codified rules l'

1 l'

l l

l 5

10-2 b

+

0-or l

i 1

8 issued under its authority, preempts state laws with regards to all.

matters. pertaining to radiological safety of the operation of nuclear i

power reactors. Where the Fitness-for-Duty Rule imposes a requirement on the licensee related to' safe operation of the reactor, the Fitness-

?

for-Duty rule preempts any conflicting state law.

l 10.5 How should licensees deal with persons who have had a confirmed positive test result at another plant that uses cutoff levels different than I

employed at your facility? For example, licensee "A" uses a standard of 100 nanograms and licensee "B" uses a' standard of 20 nanograms per

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milliliter for the initial screening test for marijuana, with respective confirmatory cutoff levels of 20 and 4 nanograms, respectively.

l Answer:

Under the' provisions of 10 CFR 26.71(b), a confirmed positive

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test result (without the levels detected) is a transferable record to be.

provided in response 'to a suitable inquiry made under the provisions of 10 CFR 26.27(a).

Furthermore, the suitable inquiry to determine if the f

c person had " tested positive for drugs" would be limited to test results received and determined as a confirmed positive by the Medical Review Officer.

The fact that a person has used drugs is not altered by use of a different cutoff level; the ability to detect drug use is affected.

10.6 If a person can be removed for cause from the workplace, cannot a preliminary screening result, in combination with observation of unusual behavior, allow management to take action before a test result is r

confirmed by an MRO determination?

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'O Answer:

The unusual behavior should' constitute sufficient basis for temporary suspension of unescorted access and.the conduct of a for-cause -

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10 CFR 26.24(d) and Sections 2.7(g) and 2.9(c) prohibit management from having access to either preliminary screening or initial screening results.

10.7 What is acceptable management and medical assurance of satisfactory ehabilitation?

r Answer:

That is up to each licensee to determine.

As advances in the state-of-the-art occur, several approaches may become available.

Currently, licenseeg could set up a program to have these people periodically exaniined on an unannounced basis.

Licensees also could employ a radioimmonassay test of hair that consists of taking a few strands of hair, usually from the scalp.

Since hair grows about one cm per month, the strands can be cut into lengths corresponding to specific periods of interest.

For example, if a six centimeter sample is obtained it could be cut into 6 one centimeter sections, each representing approximately one month of drug use history.

The test results of several successive segments establishes the pattern of drug use during the period in question.

10.8 If a preliminary screening test shows drug use, what can management know and do?

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Answer:

" Management" may'not be informed of any random test result not reviewed and confirmed as positive by the Medical Review Officer, as j

required by 10 CFR 26.24(d) and Sections 2.7(g) and 2.9(c) of Appendix A.

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'It follows that management may take no action,-unless EAP personnel notify i

. management that the individual's condition may be a hazard to himself or i

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See related discussions at 6.4, 6.5, 6.8, and

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A 10.9 If management is informed of the results of a preliminary test, what l

enforcement action will the NRC take?

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Answer,: ' If not justified (see Section 26.25),-such action would

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constitute a violation of 10 CFR 26.24(d), and Sections 2.7(g) and 2.9(c)

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of Appendix A to Part 26, and would fall under Supplement VII of the NRC's Enforcement Policy as a Severity III violation.

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i-10.10 What reasonable actions should be taken with known off-duty drug

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or alcohol abuse? For incidents that result in arrest?-

I Answer:

That is up to each licensee to determine.

Actions similar o

to what the licensee would take had the event occurred on site could be considered. The rule did not cover such situations because it is a

believed that current licensee personnel policies address matters

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such as criminal acts off the job.

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' 10.11 Does an off-site drug arrest count as one bite of the apple?

I; Answer:

NRC assumes that existing personnel policies deal with crindnal u

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acts, particularly felony convictions.

If someone is retained. NRC Lf-would expect appropriate counseling and action.

Should a subsequent' drug related incident occur, it would be prudent to remove the perr:en 'tw unescorted access.- Such information'should be passed on in response to a suitable ' inquiry.

(l 10.12 Since management must be notified, is a'self referral to EAP considered a first test failure?

o Answer:

No. Since management is not'normally notified if a person l

self-referred to the EAP, a positive test resulting from an initial assessment would not-be considered a first test failure on the employee's personnel or medical records.

Any determination of

subsequent' drur, use while under treatment-would be considered a' positive test result. reportable to management.

10.13 What action should be taken if the alcohol test results are under 0.04% BAC, especially with those tests that are taken later in the shift that would make you suspect that either the person came into work drunk or was drinking on the job?

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Answer:' Each licensee should decide what actions are appropriate; If

'the tine elapsed since start of work indicates that the individual's BAC was above 0.04% while on duty, the licensee'should take appropriate s

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h 10.14 What are effective deterrences-for alcohol abuse if a. licensee has a i

.different policy for alcohol than for drugs?

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Answer:

Section 26.27(b)(5) requires that sanctions for confirmed misuse of alcohol'be sufficient to deter abuse of legally obtainable t,

substances as a substitute for abuse of proscribed drugs. What constitutes a sufficient deterrent is for each licensee to determine.

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'10.15 What sanctions are appropriate for prescription and over-the-counter drugs?

Answer:

The licensee has discretion as to what action should be taken.

J10.16 What are acceptable sanctions for alcohol abuse and refusal to be tested?

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' Answer:' These sanctions are at the discretion of the licensee.

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The NRC would expect.that a person refusing to be tested, at'a minimum, would not be granted unescorted access to the protected l

areas.

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l' 10.17 Who will take' the lead in the development of a list of approved or risky over-the-counter and prescription drugs?

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Answer:.This apparently will be left to the licensees since neither l

i NUMARC nor.EEI indicated during the workshop that they would take the i

lead in the development of such a list.

This issue was discussed in some detail in Chapter 3 of NUREG/CR-5227, Supplement 1.

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11.0 REPORTING REQUIREMENTS

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b 11.1 What are the reporting requirements concerning persons above 0.04% BAC F

when called in and when on-call?

j Answer:

Section 26.73 requires only that the licensee report such an E

event involving licensed operatars or supervisory personnel determined to,

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f be unfit for scheduled work due to the consumption of alcohol.

Therefore, if a licensed operator or supervisor is called in, the assumption is that he was not scheduled for work, and no report is required.

If the licSnsee's policy considers."on-call" as constituting

. scheduled work, then such persons being above 0.04% BAC would be reportable.

Furthermore, the NRC would expect licensees to exercise prudent judgement on whether or not unusual situations should be reported as a.significant fitness-for-duty event under the meaning _of 10 CFR 26.73(a). Note: Significant fitness-for-duty events are not limited to the examples contained in 26.73(a)(1) and (2).

11.2 If a licensee tests other drugs or uses lower cut-off levels, what are the reporting requirements?

l' Answer:

The NRC would expect that if someone has violated the licensee's Fitness-for-Duty Program, that it be reported in accordance with 10 CFR 1

L 26.73 when applicable, and included in the program performace data 1

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, submitted to the Commission in accordance with 10 CFR 26.71(d).

This includes other drugs and experiences with lower cut-off levels.

To meet j

the requirement in 26.71(d) to include the results of tests using lower

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cut-off levels, the data should be provided so that the number of people f

identified at lower cut-off levels can be compared to the number _ that

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would have been identified at the cut-off levels established in the rule.

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11.3 If you call in an employee who is not scheduled for work or formally "on call" and the individual says he or she has been drinking and tests 0.04%

t BAC or higher, is this reportable to the NRC?

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Answer:

No.

11.4 What are the reporting requirements if a person on-call is tested positive for alcohol?

h Answer:

10 CFR 26.73 requires reporting of acts by licensed i

operators or any supervisory personnel involving the use of alcohol within-4 the protected area or resulting in unfitness for scheduled work.

Therefore, if the person is not a licensed operator or supervisor no report is required.

Likewise, if the work is not scheduled, no report is required.

"On call" is generally considered "on duty." Licensee judgement should be used to determine the appropriateness of reporting fitness matters beyond the minimum reporting requirements. For example, a site manager whose BAC is less than 0.04%, but has alcohol on his breath 11-2

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i' may be the cause of a news media report and therefore come to the

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11.5 If a licensed operator is denied access, is it reportable immediately as t

L it is today, or under the time-frame in the rule?

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Since the effective date of the rule is July 7,1989, the

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licensees may now choose to report such an event under the provisions of 0

26.73.

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11.6 Must the NRC be notified on fitness-for-duty violations involving l

L contractor supervisory personnel?

I l-Answer:

Yes. A report should be made under the provisions of 26.73(a)(2) irrespective of whether the violation was ~under a licensee's' program or under a contractor's program approved under the provisions of 10 CFR 26.23.

Licensees should exercise care so that more than one licensee does not report the same contractor event under 26.71(d).

l 11.7 Should a finding of alcohol or drugs within the protected area (no person i

in possession) be reported? If so, under 73.71 or 26.73?

Answer:

Yes.

Possession would be inferred and would be required to be reported as a significant fitness-for-duty event under the meaning of 10 CFR 26.73(a). Note:

Significant fitness-for-duty events are not limited to the examples contained in 26.73(a)(1) and (2).

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11.8 Shot:1d the attempted introduction of alcohol or drugs into a protected h

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-area be~ reported? What if the person is a visitor?

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That would depend upon the circumstances.

Should the individual f

be a licensed operator or supervisor, a report should be made to the NRC;

'a sumnary entry in the semi-annual report for most other instances would be appropriate.

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11.9 On the NUMARC data collection sheet, do all contractors do their own data E

reporting,'or does the utility consolidate?

Answer:

There is no requirement for a contractor to send the data to the NRC. The requirement is placed on the licensee.

The NUMARC data collection form has room for reporting such data.

The licensee,'in his contract, should require that such information be provided.

How this is

- accomplished is left to each licensee.

11.10 Could the licensee ask the contractors'to submit the data collection form i

to the licensee?

Answer:

Yes.

The licensees could require to contractor to do that.

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H: wever, caro sh uld be exercised so that more than one licensee doesn't report.the same contractor experiences, t

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12.0 MISCELLANEOUS L

12.1 What is meant by a " nominal" frequency, as used in 26.21(b), 26.22(b), and L

26.80(a)? 'Is it a one-month slack? Can it be plus or minus three months?

i' Answer:

Nominal" is meant to provide reasonable lattitude.

Plus or minus

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one month would be reasonable.

Plus or minus three months would be consistent with the 25 percent maximum allowable extension of a specified interval as described in Specification 4.0.2 of the Standard Technical Specifications.

This would be. acceptable provided it is not used re-:

E peatedly as an operational convenience to extend the training' interval beyond that specified.

12.2 Will there be'a new SALP functional area for Fitness-for-Duty?

i Answer:

Current NRC policy permits the Regions to add topics.to the SALP as they may deem necessary.

There is currently no initiative to aod Fitness-for-Duty as a new SALP functional area.

The current guidance includes Fitness-for-Duty as one of several activities under the security i

functional area.

12.3 Can licensees accept HHS audits of the certified testing laboratories?

Answer:

No.

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o 12.4 Can licensees accept contractor audits of HHS-certified laboratories if the contractor has a program reviewed and approved by the licensee?

Answer:

Yes.

12.5 Can licensee "A" accept licensee or contractor "B" audit of a testing laboratory if licensee or contractor "B" doesn't require as stringent cut-off levels or test for additional drugs?

Answer:

No.

The audit by licensee or contractor "B" would not assure that the laboratory is meeting the more stringent requirements of licensee

ugu, 12.6 Does the requirement to obtain medical assurance that a removed individual has abstained from drugs for three years constitute handicap discrimi-nation under the Rehabilitation Act, as amended in 1978.

Answer:

No.

(To be developed.)

12.7 Some licensees have truck drivers, tug boat operators, and other employees that must be covered under both Department of Transportation and NRC rules.

Where the rules conflict, particularly if a licensee wishes to use lower cut-of f levels, test for additional drugs, or use split samples, what rule must be met?

Answer:

The Deputy Assistant General Counsel for Regulation and Enforcement, Department of Transportation has informed the NRC that for phrposes of compliance with DOT rules, licensees should collect and 12-2

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test separate specimens for each applicable rule and program unless the t

licensee's program is consiste:nt with the DOT rule.

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.This previous Central File material can now be made publicly available.

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00 NOT ese thee form es a RECORO of appewels, concurrences, disposals, steerenees, and similar estione l

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Material Related to CRGR Meetina No.170

(.l" to be made Publicly Available f

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l 1.

Memo dated October 18, 1990 for J. Taylor from E. Jordan, subject:

Minutes of CRGR Meeting Number 170, including one enclosure which was not previously released:

L, a summary of discussions of a proposed NUREG regarding the Fitness-for-Duty Rule, including one attachment.

2.

Memo dated September 18, 1989, for E. Jordan from J. Snierek forwarding review materials on a proposed NVREG regarding the Fitness-for-Duty Rule, s

  • J 3/p,7 9O Sent to PDR on:

p-Note:

This is a partial release.

Material related to discussions regarding access authorization are not yet releasable. (E#c40sch'J To rNE

/0/19/90 Ma t9 0 )

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