NRC-88-0282, Comment on Proposed Rule 10CFR26 Re Fitness for Duty Program Including Random Drug Testing.Util Endorses NUMARC Comments on Rule

Comment on Proposed Rule 10CFR26 Re Fitness for Duty Program Including Random Drug Testing.Util Endorses NUMARC Comments on Rule

ML20206M778
Person / Time
Site:	Fermi
Issue date:	11/17/1988
From:	DETROIT EDISON CO.
To:	NRC OFFICE OF THE SECRETARY (SECY)
References
CON-NRC-88-0282, CON-NRC-88-282, FRN-53FR36795, RULE-PR-26 53FR36795-00356, 53FR36795-356, NUDOCS 8812010404
Download: ML20206M778 (10)

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Novenber 17, 1988 NIC-P8-0282

%e Secretary of the Comission U. S. bbclear Regulatory Comission Washington, D. C. 20555 Attention: Docketing aM Service Branch Paferences: 1) Fermi 2 NIC Docket No. 50-341 NIC License No. IPF-43

2) Proposed Fitness-for-Duty Program Pule (Federal Register, Vol. 53, No.184, dated Ttursday, Septenber 22, 1988)

Subject:

Detroit Eison's Comrents on the Procosed Fitness-For-Duty Rules l

ne ibclear Pagulatory Comission (NIC) has proposed to add a new part to its regulations to require licensees authorized to operate nuclear

> power reactors to innlement a fitness-for-duty program; the general objective of the rule is to provide reasonable assurance that nuclear j power plant personnel are not under the influence of any substance, legal or illegal, or mentally or physically inpairal from any cause, which in any way adversely affects their sbility to safely and j

conpetently perform their duties.

f he cormerits containst herein are st^ .itted on behalf of the Detroit Eison Comany in response to the NIC request for corments on the I

proposed fitness-for-duty program rule.

Se Detroit Eison Conpany has, for a number of years, been actively I practicing a nunber of the proposed fitness for duty prograrn j couponents. Experience has shown that by taking an aggressive approach arx! inclementing a realistic, yet non-offensive program, l

i personnel have been deterred from entering the Fermi 2 site while uMer the influence of illegal drugs ard/or ricohol. Se final rule

' will help assure a tough irdustry-wide @proat.. to Pitness-for-Duty issues.

881201C404 881117 PDR l $"S R36795 l

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t UStGC Novenber 17, 1988 10C-88-0282 Page 2 ne Detroit niison Comany endorses the tuclear Managenent and Resources Council (MMAIC) coments to the NIC on the proposed Fitness-for-Duty Rule (Attach.nent 1) with the exception of itens detailed in Attachnent 2. Attachnent 3 is the Detroit Edison response to the request for information on various topics found between pages 36795 and 36823 of the Federal Reaister notice preceeding the actual text of the rule. ,

l Additionally, in response to the Commission's request for data to i support testing alternatives, Detroit H31 son has sent, under separate  ;

cover to Mr. Loren Bush, the Fermi 2 Fitness-For-Duty statistics I accunulated since the program was instituted. l 1

, If you have any questions, please contact Mr. Arnold Ja2fmann at (313) 586-4213. >

Sincerely, 1

Attachments '

f cc: Mr. A. B. t) avis l l Mr. R. C. Knop Mr. W. G. Rogers Mr. J. R. Stang i

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Attac1 ment

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1. 1 DRAF1 November 18, 1983 Hr. Samuel J. Chilk Secretary U.S. Nuclear Regulatory Comission Washington, D.C. 20555 A110. tion: Docketing and Service Branch Re: Proposed Rule - Fitness-for-Duty Program 53 FR 36795 (September 22,1988)

Reauest for Coments

Dear Mr. Chilk:

These comments are submitted on behalf of the Nuclear Management and Resources Council, Inc. ("NUMARC") in response to the request of the U.S.

Nuclear Regulatory Commission ("NRC") for comments on the NRC proposed rule titled Fitness-for-Duty Program (53 FR 36795).

NUMARC is the organization of the nuclear power industry that is responsible for coordinating the combined efforts of all utilities licensed by the NRC to construct or operate nuclear power plants and of other nuclear industry organizations in all matters involving generic regulatory solicy issues and on the regula*,ory aspects of generic operational and tecinical issues affecting the nuclear power industry. Every utility res sensible for constructing or operating a comercial nuclear power plant in tie United States is a member of NUMARC. In addition, NUltARC's members include major architect-engineering firms and all of the major nuclear steam supply system vendors.

I NUMARC supports the NRC's initiative in addressing concerns relating to the fitness-for duty of nuclear power plant personnel. The industry has undertaken, individually and collectively, a number of efforts to develop l and implement fitness-for duty programs which, as the Comission has acknowledged, have resulted in much progress being made in achieving an

, environment in which nuclear power plant operations are conducted free from

the effects of alcohol and drug abuse. The industry supports the Comission's Policy Statement on Fitness-for Duty of Nuclear Power Personnel that was published in the Federal Reaister on August 4,1986 and recognizes the desire of the NRC to proceed with a rulemaking to supplement its Policy Statement.

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Mr. Samuel J. Chilk DRAFT November 18, 1988 Page 2 In general, NUMARC supports the proposed rule. Our submittal includes three attachments that provide our views on this important subject:

A. General coments on the proposed rule B. Recomendations for specific wording changen in the proposed rule C. Responses to the questions posed in the Discussion section and the Appendix of the proposed rule.

Our coments reflect the industry's experience with the effects of drug abuse in the workplace and current fitness-for-duty programs. Based on that experience, we believe that the Comission's proposed program is well focused, albeit in need of some modification as detailed in the Attachments. Random testing is an important and helpful, but not indispensable, element in an ,

effective fitness-for-duty program in that it provides a strong deterrent effect; as such, the principal fecus of random testing should be on deterrence and not on detection.

Although the proposed rule reouests coments concerning alcohol abuse (and we have responded to those questions), explicit provisions for dealing with alcohol abuse are not detailed in the proposed rule. As stated in our coments, we support inclusion in the proposed rula of basic requirements

, for alcohol testing. However, we believe that the complexity of this subject precludes our providing more definitive coments without a proposed rule to consider. If the Comission datermines that it is appropriate to require specific fitness-for duty program elements dealing with alcohol abuse (e.g.,

threshold levels, testing procedures) that are more extensive than licensees presently address in their individual fitness-for-duty 5,rograms, we strongly encourage the Comission not to include prescriptive program elements dealing with alechol in this rule but to develop an independent rule that would be noticed for public coment.

We wish to advise the Comission that the industry intends to supplement the EEI Guidelines for fitness-for duty programs to provide guidance to the industry on the implementation of the NRC's regulations.

We appreciate the opportunity to coment on the proposed rule and would welcome tie opportunity to discuss our coments further with appropriate NRC staff personnel.

l Sincerely, j Joe F. Colvin JFC/RWB:eeq Attachments i

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DRAFT ;

4 November 18, 1988 l i

Attachment A i i NUMARC GENERAL COINENTS 1 ON THE NRC'S PROPOSED RULE -

, ON FITNESS-FOR-DUTY PROGRAMS 3

7 Present licensee fitness-for duty programs have been developed through i 1.

industry initiatives (e.g., 'EEI Guide to Effective Drug and Alcohol /

Fitness-for Duty Policy Development"). However, we have learned from i experience that no one situation is like any other; an effective fitness- i i for duty program developed by one licensee may be significantly different {

i than that developed by another because of differences in tradition, j culture, state laws, collective bargaining agreements, and managerial

) style. The NRC should recognize this necessary diversity and provide f j licensees with the ability to implement the prescribed program elements .

that meet the regulatory requirements in the manner that is best suited l J to their individual circumstances. [

Because of the intricacy of the rule, we urge the NRC to evaluate the  ;

i industry's comments in their totality; the goal uf the NRC and the i industry to develop and implement comprehensiva and effective fitness- l

for-duty programs can only be achieved if a rule is idopted that is i integrated in all respects and which reflects the poetical experience {

gained to date. To ensure that the principles of the rule can be f

, effectively implementad, we request the Comission include in the final  !

rule an explicit delegation of authority to the NRC staff to enable it  ?

i to evaluate special circumstances and, as appropriate, grant exemptions ,

l' or exceptions from specific requirements of the rule for circumstances l not now foreseeable such that the underlying purpose of the rule can be i

achieved.  ;

Althoughtheindustryrecofnizesthedesirabilityofimprovingthe f

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auditability and comparabi ity of program results, we recommend that  !

the NRC establish the threshold levels recomended in discussion question  !

1. 4 in Attachment C but provide licensees with the authority to impose ':

, program elements most appropriate for their programs (e.g., impose  !

requirements more stringent than those provided in the proposed rule), i

, 2. In view of the complexity of this issue and the need to ensure that a

( workable program will result, NUMARC requested that the coment period ,

in this rulemaking be no less than 120 days (NUMARC letter to Mr. Chilk l dated August 5, 1988). Because the coment period provided for the proposed rule was only 60 days NUMARC has focused on the ectual  ;

requirements of the proposed rule and has not been able to develop i l

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c DRAFT detailed comments on all aspects of the proposed rule (particularly the material provided in the Supplementary Information section of the proposed rule).

3. The NRC is responsible under the Atomic Energy Act for ensuring protection of the public health and safety. As a matter of law, the NRC has exclusive jurisdiction over the radiological safety aspects of the construction and operation of comercial nuclear power plants. To ensure appropriate understanding of this principle by those reading this rule, it might be helpful for the NRC to clarify that its regulations in this area preempt inconsistent state or local laws or regul,ations.

4. The NRC should not prescribe sanctions relating to employment but rather should limit the reach of the proposed rule to decisions related to authorizing unescorted access to protected areas. In all cases, '.he NRC should ensure that the provisions of the proposed rule on fitness-for-duty are consistent with the NRC's Access Authorization Program.

5. An important distinction must be made between fitness-for duty program elements related to alcohol abuse, which are concerned primarily we.h the impairment of an individual's job performance, and drug abuse, w.51ch may involve impairment but predominately relates to the unreliability and untrustworthiness of the individual, which is connoted by the commission of illegal acts. We do not believe that it is necessary for the NRC to prescribe detailed regulations pertaining to alcohol abuse.

It is premature to speculate on what prescriptive requirements the NRC might consider if it does consider program elements related to alcohol abuse, but would make the following observations for NRC evaluation as it considers this subject: (1) Industry experience supports alcohol testing by breath detectors; (2) Administratively, it would be beneficial to conduct alcohol and drug testing 6t the sarre time; and (3) The establishment of a cutoff level for management action related to denial of unescorted access at a blood alcohol concentration of 0.04% would be consistent with the blood alcohol concentration level established by the Federal Highway Administration for commercial motor vehicle drivers (53FR39044 October 4, 1988). The experience of licensees with alcohol abuse demonstrates, even more so than with drug abuse, that individual licensees need flexibility in determining the appropriate sanction to be imposed on individuals whose fitness-for duty has been compromised by the consumption of alcohol.

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6. The sample size required for unannounced tests imposed in a random manner

('randos testing") is unjustified and unjustifiable. The random testing provision is but one additional element to substantial existing fitness- '

for-duty programs in our industry. A number of federal agencies (e.g.,

Federal Aviation Administration Federal Highway Administration, Urban Mass Transportation Administration, and the Research and Special Programs Administration of the U.S. Department of Transportation) have promulgated

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regulations establishing anti-drug programs; none of those agencies has prescribed a sample size for random testing any higher than 125% of the covered employees. The adoption of a testing rate as high as 300%

discounts the other valuable fitness-for duty program elements that NRC licensees have already implemented (i.e., background investigations, psychological screening, continuous behavioral observation, Employee Assistance Programs, training, and education). Further, individuals granted unescorted access at nuclear power plants are in a far different environment than those in the military, where testing at the 300% level is conducted. Also, the average age, family responsibilities, career aspirations, mobility of assignment, stability of the work force, and the identified drug use within that population are all far different than is present in the military.

An annual sampling rate of 100% of the designated individuals provides a strong deterrent effect. Further, an arbitrarily excessive sample rate would dramatically and adversely affect productivity and morale, cause a three-fold disruption of the work environment, and potentially could pose an unjustifiably greater negative effect on safety and quality.

The climate of distrust, constant harassment, and disruption in the workplace created by an unjustifiably high test rate could significantly affect the industry's ability to attract and retain the qualified individuals necessary to operate and maintain our plants because of the presumption of untrustworthiness that would be implied. Lastly, the threshold levels we recommend in discussion cuestion #4 in Attachment C, which are in some cases lower than those suggested by the NRC, provide the ability to detect drug usage at a lower level and to detect drug use that occurred at an earlier point in time. This provides additional justification for conducting random testing at a lesser rate than that which would result from the adoption of a 300% sample size. In place of either of the alternatives provided by the proposed rule, we stronaly recommend that the NRC adopt a 100% annual sample size requirement and reconsider both the sample size and threshold levels in three years, after evaluating the data that has been developed so that appropriate regulatory changes could be implemented. The NRC should include in the Statement of Considerations section of the final rule its intent to reevaluate these provisions after a period of three years. This subject is further addressed in Attachment C in response to discussion question f3.

7. The "Handatory Guidelines for Federal Workplace Drug Testing Programs" (53FR11970) issued by the Department of Health and Human Services (DHHS) were developed in accordance with the Pre;ident's Executive Order No.

12564 dated September 15,1986 and 5503 of Public Law 100 71 dated July 11, 1987. These DHHS Guidelines were written for federal agency workplace drug testing programs and explicitly state that "they do not apply to drug testing under any legal authority other than E.O.12564." They I cannot be used for direct application to NRC licensee programs. For example, the NRC proposed rule (subparagraph 26.24(c)) provides that 3A-

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licensees must test for additional drugs that may be prevalent in that geographic locale but the DHHS Guidelines (subparagraph 2.4(e) and (f))

require laboratories to receive the written approval of the Secretary of DHHS for test methods and testing levels for drugs other than the five specified in the DHHS Guidelines.

For that reason, and because they may at some future time be changed by DHHS in a manner that might conflict with the NRC's application of these Guidelines to NRC licensees' fitness-for-duty programs, the NRC should refer as appropriate to the DHHS Guidelines but should directly implement in its own regulations only those portions of the Guidelines that are applicable to NRC licensee fitness-for duty programs.

We recommend that the NRC incorporate into this proposed rule the sections of the DHHS Guiielines identified in discussion question #4 in Attachment C with wording changes and accompanying definitions as may be appropriate.

The NRC should specify in its regulations that licensees are to use laboratories certified to the DHHS Guidelines, thereby relying upon the laboratory operation and certification requirements provided in the applicable sections of the DHHS Guidelines and obviating the need for the NRC to establish an independent certification program. The NRC should include in the final rule authorization for laboratories certified to the DHHS guidelines to conduct drug tests consistent with NRC and licensee requirements.

8. The NRC's proposed rule imposes responsibilities on licensnes for contractor personnel performing activities within the scope of the regulation. As m itten, the draft regulations pim:e the licensee in the position of having direct resoonsibility for some aspects of the contractor's employee relations program (the appeal process, employee assistance programs, etc.). As a matter of principle, the NRC should not, through this rule, establish rights of or benefits to contractors or contractor employees that they do not otherwise have by law or contract.

9. For licensees to be able to satisfy their requirements under the proposed rule, and because the same principles that underlie licensee fitness-for-duty programs apply, the NRC should clarify whether NRC contractor personnel will be covered by the NRC program or will be treated the same as licensee contractors.

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s' DRAFT Attachment B November 18, 1988 NUMARC RECOMMENDATIONS FOR SPECIFIC WORDING CHANGES IN THE NRC PROPOSED FITNESS-FOR-DUTY (FFD) RULE The following specific connents and supporting rationale are provided as requested by the NRC proposed Fitness-for-Duty Rule (10CFR Part 26).

1. Pace 36823. third column. earaaraoh 26.1. line 5:

Add the word "power' before the word "industry" at the end of the paragraph so that the sentence ends with "licensed nuclear power industry.'

Rationale: To be specific as to what industry is being regulated.

. 2. Paae 36823. third column. Daraoraoh 26.2. line 11:

Change the word "respond' to the phrase "physically report." The sentence should read, "... personnel required to physically report to a licensee's Technical Support Center ..."

Rationale: To be specific in addressing those individuals that physically report to the TSC or EOF. See discussion question #8 in Attachment C regarding the desirability of deleting separate requirements for TSC/ EOF personnel.

3. Pace 36823. third column. earaaraoh 26.2. line 16:

Change 'NRC representatives" to "NRC employees" and add ' state and local officials."

Rationale: For clarification and to make the list complete.

4. Pace 36823. third column. caraaraoh 26.2(b) line 4:

Change '90' days to read "180 days."

Rationale: Insufficient time is provided to implement this major modification to licensee fitness for duty programs. The key to the program is random drug testing; however, there are practical and 18-

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t administrative relationshiss betwten the testing program and other i requirements. Therefore tie entire program should be implemented ,

at the same time (after 180, days). l-1

5. Pace 36824. first column. naraaraoh 26.3:

Add a new definition: "Contractor" means any company or individual with

, which the licensee has contracted work / service to be performed inside the protected area boundary, either by contract, purchase order, or verbal

• l agreement.

i Rationale: To provide a definition to clarify a category of on site personnel >

j that are not licensee employees but are subject to the drug testing  ;

Provisions of this rule.  :

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6. Pace 36824. first column. oaraaraoh 26.3. line 14: l

{ In the sentence beoinning "Drug abuse..." should be changed to read, "Drug f

abuse means the use of a psychoactive substance without a legal medical  !

prescription." (

Rationtie: Any discussion of impairment is inappropriate in a zero tolerance drug abuse program. This also removes doubt about the term l "medical purposes."  ;

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7. Pace 36824. first column. car.Agraeh 26.3. line 25:

Sentence beginning "For-cause testing..." should be changed to read: "Fore t cause testing means chemical testing based upon reasonable suspicion that a person may have demonstrated aberrant behavior."

Rationale: Removes the term "impaired," to be consistent with previous coments. Company procedures determine who can request for cause ,

i testing. Supervisors are responsible under the continuous l l behavioral observation program of the Access Authorization Policy  ;

l to request drug testing for persons whose behavior is questi6nable. i l

8. Paae 36824. first column. carharaoh 26.3. line 19:  ;

( Sentence beginning "Impairment' ... should be deleted. ,

I l Rationale: To presume diminished performance requires an initial standard l i against which the person is measured. This very subjective l d6 termination should not be defined in the rule because there is no agreed upon definition nor is there any scientifit./ medical guidance to determine "impairment on the job" for any specific l reason.

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9. Paae 36824. first column. oaraaraoh 26.3. line 53:

Sentence beginning: "Random test' ...

Substitute the word "administered" for the word "imposed."

Sh;V1d read: "Random test" reans a system of unannounced drug testing sdministered in a statistically random manner to a group so that all persons within that group have an equal probability of selection.

Rationale: The connotation of the phrase is softened from the "forced" impression of the original word.

10. Pace 36824. first column. caraaraoh 26.3. line 58:

Sentence beginning "Suitable inquiry..." delete "employment history for the past five years' and change to read "Suitable inquiry means best effort verificaticn of information obtained in accordance with the Access Authorization Program through..."

Rationale: To be consistent with and not duplicate requirements in the Access Authorization Program.

11. Paae 36824. second column. Daraaraoh 26.6:

First senteace, substitute word "Commission" for "Committee."

Rationale: To correct the wording.

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12. Paae 36824. second column. carsaraoh 26.10fa):

Add the phrase "reliable, trustworthy, and' to the first sentence so that it reads, "Provide reasonable assurance that nuclear power plant personnel are i reliable, trustworthy, and not under ...'

, Rationale: As in access authorization, reliability and trustworthiness of  ;

i individuals granted unescorted access is crucial.  !

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13. Jaae 36824. third column. oaraaraoh 26.20fa). third sentence: l Delete sentence beginning: "Licensee ..." and substitute sentence that reads: .

Licensee policy shall also address other medical or psychological factors l that could affect an individual's fitness for duty.  :

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DRAFT Rationale: The policy is carried out by the supervisor in the workplace. If in his/her judgment a person appears to be unfit for duty, the supervisor's responsibility is to have that person evaluated by the company's m'edical staff and not to determine the cause.

14. Pace 36824 third column. oaraaraoh 26.20fb):

In the first sentence sub:;titute the phrase "licensae employees' for the word

' personnel."

Should reat: (b) A description of programs which are available to licensee employees desiring assistance in dealing with drug or other problems that could adversely affect the performance of activities within the scope of this part.

Rationale: Applicability of this paragraph is for licensees. Centractors, vendors, etc., would have separate programs if required. This item is further discussed in general corment #8 of Attachment A.

15. Pace 36825. first column. Daraaraoh 26.21(b):

In the second sentence substitute the term "biennial" (eva y two years) for

' annual." -

Should read: Refresher training must be completed on a bient.ial basis or more frequently where the need is indicated.

Rationale: Experience has shown that refresher training every two years is adequate. If there is concern that retraining is needed after the first year that this new program is implemented, then specify that requirement with training being biennial thereafter.

16. Paae 36825. first column. earaaraoh 26.22:

• li reistence to training of escorts should be deleted except for paragraph (5)(b) which should be rephrased. All references to behavioral observation techniques and treatment should be deleted.

Effected sentences should read:

Paragraph title: "Training of supervisors."

Subparagraph (4): "Behavioral observation techniques; and "

Subparagraph (5): ' Procedures for initiating appropriate corrective action, to include referral of employees for medical assessment or counseling."

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Subparagraph (5)(b): "Non-supervisory persons assigned to esc. , duties shall be provided basic training to familiarize them with the matters contained in 26.22(a)(3), (4), and (5)."

Rationale: Behavioral observation is a technique used to determine a change in behavior and is not the purview of escorts but of supervisors.

Escorts do not require this type of training to perform their duties. The people they are escorting are not "unescorted" and have passed through security entrance procedures.

As discussed in a previous comment, the term "impairment' is subjective. A listing of specific behavioral observation techniques is inappropriate because the principle of behavorial observation is that all changes in behavior must be evaluated over a period of time- This principle is addressed by the EEI Guidelines and is in each utility's training program for supervisors.

17. Pace 36828. first column. Daraaraoh 26,22(c):

First ser.tence change: "3 months of' to '6 months following."

Second sentence change: "an annual basis' to "a biennial basis" and delete the remainder of sentence.

Should read: (c) Initial training must be completed prior to assignment of duties within the scope of this part and within 6 months following initial supervisory assignment, as applicable. Refresher training must be completed on a biennial basis.

Rationale: Utility experience indicates 6 months provides a more appropriate time frame for administration of the training program. Biennial review would be consistent with a previous comment.

18. Ptae 36825. first column. earaaraoh 26.23fa):

Add phrase "at the licensee's option' after the word 'or' and substitute j ' program' for "policy." Delete the word "effective.'

, should read: (a) The contractor is responsible to the licenses for adhering

to the licensee's fitness-for duty program or, at the licensee's option, maintaining and adhering to a fitness for duty program which meets the standards of this part; and l

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DRAFl Rationalu To clarify that the licensee may choose to require a contractor to have its own fitness-for-duty program. The word ' effective" is subjective and without criteria to measure effectiveness.

The requirement should, rather, be to conform to the requirements of this part.

19. Pace 36825. second column. earaoraoh 26.24f a):

Add phrase 'on or off site' after the word "abuse.' '

Should read: (a) To provide a means to deter and detect drug abuse on or

! off site, the licensee shall implement the following chemical testing programs '

for persons subject to this part.  ;

a Rationale: To clarify that the requirements of this program are independent of the location of drug abuse.  ;

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20. Pace 36825. second column. caraaraoh 26.24f a)(1): l l  !

Delete the phrase "immediately before the initial" and substitute "not more  !

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than 60 days prior to.'

should read: (1)* Testing not more than 60 days prior to the granting of i

unescorted access to protected areas or assignment to activities within the scope of this part.

Rationale: The term 'immediately" is not precise and is very restrictive.

A 60 day period provides for a reasonable admir.istrative period,

! especially for the pre employment badging process.

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! 21. Etgs 36825. second column. oaraorneh 26.24(a)(2)(i) and (11):

} The two alternatives listed should be deleted and the following added to the end of rubparagraph (a)(2): "The tests must be administered frequently j throughout the year at an annual rate equivalent to 100 percent of the population subject to such testing."

Rationale: The requirement that "at least 90 percent of the individuals within the scope of the rule are insted each year' is unreasonable and the '300 percent annual random test rate" is excessive. See general comment #6 in Attachment A.

The primary purpose of any random drug testing program is deterrence with the added benefit of reasonable detection if the deterrence has not been totally effective. The requirements of this paragraph discount "deterrence" and inappropriately shift the emphasis of the program to detection. Emphasis on detection 68-

DRAFT cay be appropriate for the uniformed service: because of theiryouthful and non permanent populations, but this is not the case in this country's nuclear power industry.

Random drug testing is a strong deterrent to drug use. However, it must be recognized that drug testing is just one element of an overall fitness-for duty program.

The experience of the utilities that have random drug testing programs would indicate there is not a large populati;.. of drug users among their employees as demonstrated by less than 1% post-tive drug test results. Based on industry experience thera is no definate c9rrelation between sample size and positive drug test percentage results. The fact that the 1% rate was achieved with programs that had sample sizes ranging from 20% to greater than 100% demonstrates that a higher probability of detection does not alter the basic deterrent effect across the range.

Many of these programs are successful using selection rates of about 25%. As noted in our general comments, a rate of 300%

, could actually be counter to safety. See discussion question f3 in Attachment C.

22. Paae 36825. second column. earaorach 26.24fal(3):

The "testing for'cause" examples need better definition. The following is offered:

Examples of circumstances that may lead a person of reasonable caution to conclude that a potential violation is occurring or has occurred include, but are not limited to:

onsite observation of use or possession of drugs or alcohol; conduct consistent with being under the influence of drugs or alcohol; hearsay or anonymous allegations where investigation shows that additional corroborative information or circumstances exist; involvement in an unusual or suspicious circumstance that could reasonably lead to a conclusion of possible drug or alcohol involvement;

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a situation resulting in a radiation exposure or release of radioactivity in excess nf regulatory limits that could indicate possible drug or alcohol involvement; l -

situations involving actual or potential substantial degradations of the level of safety of the plant that could indicate possible drug or alcohol involvement.

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UKAP' Rationale: The Wagraph does not cover other possible instances and it leaver too much room for interpretation when terms like 'imediate' and "personal injury' are used.

23. Pace 36825. second column. earearsoh 26.21.(n.l.(.f.).:

Delete the phrase "a random basis" and substitute "unannounced intervals."

Should read: (4) Follo up testing on unannounced intervals to verify continued abstention frorr, '.he usa of f':ugs.

Rationale: Follow-up testing is t uanounced and more frequent but is not

' random" as used elpo.bere in the rule.

24. Paae 36825. second column. caracraoh 26.24fb):

This subpraragraph should be Gleted and in its place sui.stitute the applicable sections of the DHHS Guidelines as tailored to the nuclear power industry.

NUMARC's general recommendation is contained in Attachment C.

Rationale: See Attachment C answer to NRC discussion question #4.

25. Paae 16825. third column. eariaraoh 26.25:

Modify (pirt underlined) the first sentence to begin, "Each licensee subject to this part shall make available to their eermanent emolovees an Employee Assistance Program..."

Rationale: This paragraph should be clarified to say that only licensees need to have Employee Assistance Programs and that the licensee program is only for per.aanent licensee employees. The licensee should not be required to have non employees in their EAP programs nor should they have any responsibility for contractor, vendor, or other EAP programs. See general coment #8 of Attachment A.

26. Paae 36826. first column. earacraoh 26.25

Delete the last sentence in its entirety.

Rationale: The subject is covered in the first sentence. Also. EAP staff

! personnel are to inform the licensee of all instances of hazard, not ,iust for self referrals.

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27. Paae 36826. first column. caraaraoh 26.27:

Statement: We believe that the entire paragraph 26.27 should be deletic because licensee management has the re:3nsibility to decide these issues.

If this cannot be left to management., then the following series of coments concerning ' management actions and sanctions to be imposed' would be the more appropriate phraseology.

28. Paae 36826. f5 st column. onraaraoh 26.27fa). line 31:

In the third sentence, after the word "response,' reword the remainder of the sentence to read, "response to a licensee / contractor / vendor inquiry supported by a signed release form from the individual pursuant to the scope of this part."

Rationale: To address possible legal questions surrounding release of this information. The rule should specify that a signed release form would be required.

29. Paae 36826. first column earaaraoh 26.27(b):

Add to the end of the second sentence the phrase, "up to and including dismissal."

Rationale: Even though the proposed rule uses the phrase 'as a minimum," it.

must be made clear that discharge may be appropriate. See discus; ion question #7 in Attachment C.

30. Pace 36826. first column. earaaraoh 26.27(b)(1):

Delete the first sentence.

Rationale: It is imaterial for purposes of this paragraph to discuss where the drug use occurred that resulted in a confirmed positive drug test.

31. Paac 36826. first column. onrawach 26.27(b)(1). line 9:

Delete the phrase "for at least 14 days' and modify that portion of the sentence to read. "...within the scope of thie part for a period of time appropriate to the circumstances of the case for assessment and counseling in accordance with utility procedures."

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DRAFl R&tionale: A specified minimum time po M (14 days) implies that all cases should be treated similarly rqardless of circumstances, and could indicate neither management nor EAP 1ersonnel are competent in determining the minimuna time a person s1ould be suspended from his/her job as a result of a positive test.

32. Pace 36826. second column. oaraarach_d .27(b)(2):

Modify (part underlined) the first sentance after "possession of illegal drugs..." to read, "... possession ef illegal drugs while on site at any nuclear power plant shall be oermane.itly removed from activities within the scope of this Part." Delete the following sentence.

Rationale: The sale, use, or possession of illegal drugs on site is such a serious breach of regulation that a person that violates this rule should be permanently denied unescorted access to the ,

protected area of a plant.

33. Pace 36826. second column. earaaraoh 26.27tbif3):

i This subparagraph should have several modifications (which are underlined in the text) and should read:

(3) Should the licensee elect to reinstate unescorted access to per: ens removed for three years under the provisions of subparagraph (1) for the . use, ,of drugs and who would have been removed under the current standards of a hiring

licensee, they will not be granted untscorted access and assigned duties within tht scope of this part by a licensee subject to this Part unless the hiring licensee can obtain satisfactory assurance that the person has abstained from drugs for at least tfiNe ytars. Satisfactory assurance of the individual's 4

fitness to adequately perform activities within the scope of this l

part shall be obtained before perinitting the individual to perform activities within the scope of this part. Any person granted unescorted access or whose access is reinstated under these provisions shall be given unannounced follow up tests at least once every three months for at least one year after reinstatement of access to verify continued abstinence from drugs. Any confirmed use of cirugs through this process or any other determination of subsequent involvement in the sale, use, or possession of illegal drugs shall result in perr tent denial of unescorted access.

Rationale: This paragraph includes .equirements of the Access Authorization Policy that should not be duplicated in this rule. The imposition l of sanctioits is a manaaerial responsibility. The industry is

developing industry ge W nce to supplement the EEI Guide to i

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UMAFT Effective Drua and Alcohol / Fitness-for-duty policy Develoement to assist in uniform implementation of the final fitness-for-duty rule. Details such as appear in paragraph 26.27 are more appropriately covered by the EEI Guidelines or its supplement.

The proposed guidance in the aforementioned EE: supplement will also address issues not specifically addressed in the rule, e.g.:

a previous positive drug test would remain on a person's record indefinitely and a subsequent confirmed positive drug test result would be considered the second offense and be dealt with accordingly; during the period of a ' suitable inquiry' for drug involvement, temporary access authorization, in teordance with the Access Authorization Policy, would be available to the licensee.

34. Paae 36826. third column. esparaoh 2M:

This paragraph should have several modifications (which are underlined in the text) and should read as follows:

"Each licensee subject to this part shall establish a procedure for

].i.crse emolovees to appeal fitness for duty determinations that could have an adverse effect on the individual's employment. The procedure must provide notice and an opportunity to respond and be consonant with fundamental principles of fairness. Where applicable, grievanco review procedures contained in collective bargaining agreements covering the bargaining unit of which the employee is a member will meet this requirement, and may be used for this purpose.'

Rationale: Licensees should not have the responsibility for an appeal process for other than their own Ugloyec:. This entire paragraph deals with labor relations, which is not the purview of the NRC.

Further, many licensees have appeal procedures in place for employees not covered by collective bargaining agreements.

If the NRC requires that this subject be addressed in the rule, it must also be consistent with the Access Authorization Policy.

i 35. Pace 36826. third column. Daraaraoh 26.29f a):

i In line 7 add two new sentences as follows: "The results of tests conducted

! in accordance with this Part may not be used for any purpose other than evaluation of drug or alcohol use. Samples taken may not be used to conduct l any other analysis or test unless otherwise authorized by law."

l i

Rationale: To protect the confidentiality of personal information that may be identified during the course of testing pursuant to this regulation.

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. _ . _. __ . ~ ___ _- _ _ . _ _ _ - - _ _ _ ._

DRAFI i

. 36. Pace 36826. third column. earacraoh 26.29fb_it add Inline1andline5aftertheword"licenree(j)c"cess'thephrase' and vendors." In line 7, substitute the Wrd a for the word contractors '

' employment." This paragraph should read:

(b) The licensee, contractors and vendors shall not disclose the personal  !

information collected and maintained pursuant to this rule to  !

personnel other than assigned medical review officials, other  ;

licensees, contractors and vendors 1 itimately seeking the information as required by this part or access decisions and who  !

j have obtained a release from current or prospective employees or contractor personnel NRC representatives, appropriate law .

enforcement officials, the subject individual or his or her .

representative, or to those licensee personnel who have a need to have access to the information in performing assigned duties.  !

a Rationale: "Contractors and vendors

• are also involved in this process. l j "Employment' is not in the NRC's purview, only "access.'

j 37. Pace 36826. third column. earaaraoh 26.70fb)(1):  !

l Delete the word "effective" and modify (text underlined) t,he sentence to l read, ' Licensee is responsible to the Commission for maintaining a j fitness-for-duty program in comoliance with this part; and ...'

i Rationale: The word ' effective" is subjective and the measures of I

effectiveness for a fitness-for duty program have not been  ;

established. The appropriate role of a re  ;

j ensure "compliance" with its regulations. gulatory agency is to '

I  !

I 38. Pace 36827. first column. Daraaraoh 26.70fb)(2): l

} ,

, At the beginning of the first sentence add 'With the exception of personnel I

records, ..." before 'NRC may ..."

1 {

i Rationale: To maintain protection of personnel records. With unfettered I access to the records, there is no reason to take away copies of j these sensitive records. >

I  !

j 39. Pane 36827. f'irst column. enraaraoh 26.71td):

j Combine and modify (as underlined) the first two sentences to read: l

)

' Collect and compile fitness for duty program data (

. .hich is to be analyzed and appropriate corrective action taken.  ;

! l

} -128- I Y

l i

! t

i. _

t

DRAFT Rationale: The proposed NRC form requires information that goes well beyond the regulator's need to determine compliance with the regulation or for health and safety concerns. Licensees will be responsible

for implementing this aspect of their fitness-for duty programs and evaluating the effectivaness of their programs. The aforementioned EE! supplement will provide gu< dance to aid in uniformity in this area. The NRC form or a substitute should

, not be required. Publicly analyzing data out of context and

, without knowing the circumstances would be counterproductive to the achievement of the objectivas of the proposed rule.

l 40. Pane 36827. second column. carnaraoh 26.80f a): -

i Modify the end of the first sentence to read, "... audited after the first

. year of implementation." Change where appearing the remaining '!3 menth audit' 4

periodicity to "every three years.'

i l Rationale: After an implementation audit, the 13 month audit requi ement is i

excessive. Every three years would be consistent with WMARC

] comments on the proposed Access Authorization Policy.

l

! 41. Paae 36827. second column. onraaraoh 26.80fn). line 17:

! Modify (part underlined) the last sentence of this subparagraph to read,

! "Licensees retain responsibility to ensure comolianct of contractor programs and the implementation of appropriate corrective action. See general comment

1. 8 of Attachment A.

I i

Rationale: As mentioned in a previoJs Comment, "effectiveness

• is too subjective a term; compliance with the regulations should be the requirement.

1

42. Pace 36827. second column. earaaraoh 26.80fb):

$ Delete the term ' effectiveness' in the first sentence and modify (part

! underlined the sentence to read, ' Audits shall focus on the crearam and its l somelfie e ements to assure comolhnen and be conducted ..."

1 l Rationale: As noted in cossment #37 above, ' compliance," not ' effectiveness,"

is the measure to be used.

1

)

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.._--__-___...-___---__-.-.-_-.-,---.--__..-,-__L

, DRAFl-

, November 18, 1988 l Attachment C NUMARC RESPONSES TO THE QUESTIONS POSED IN THE DISCUSSION SECTION AND THE APPENDIX OF THE NRC PROPOSED FITNESS FOR DUTY (FFD) RULE

!. The following are responses to the NRC posed questions in the discussion section, pages 36796 and 36797 of the proposed Fitness for Duty Rule (10CFRPart26).

Discussion Ouestion 1:

Are there practical alternatives to random testing not discussed herein that provide equivalent deterrence and detection of drug use?

Comment: There does not appear to be any equally effective, practical alternative to random testing, particularly as a deterrent, currently available.

Discussion Ouestion 2:

What practical alternatives not discussed herein c=1:t that could determine physical and mental impairment?

Comment: Impairment is not the issues it is the use of illegal drugs on or off the job which could adversely affect the safety of operation or adversely reflect on the integrity, reliability, and trustworthiness of the people to whom safe operation is entrusted. The matter of trustworthiness is recognized and embodied in the Access Authorization Program.

Discussion Ouestion 3 ,

What rates of random testing and ratesting provide an acceptable probability of detection and adequate deterrence? What should be the basis for any future modifications in the rate for random testing?

Comment: As described in Attachment A, general cossent #6, we believe that the program should begin with a maximum annual testing level equal to 100%, which is the rate of the NRC's internal drug testing program. The population described in the Scope paragraph of the proposed rule should be selected on a random

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DRAFT basis to provide urine samples that are tested to the cutoff levels proposed in discussion question #4 below. Testing is to be done frequently to keep the deterrent effect highly visible. After three years of industry-wide random drug testing experience, the program should be reevaluated based on the  ;

data that has been developed, drug testing technology advances, i and the prevalence of drugs in the country, i

The sample levels of the two alternatives provided in paragraph 26.24 of the proposed rule are unreasonable and even unnecessary. The experience of the licensees that currently have random drug testing programs indicates that a random testing rate of about 25% per year produces a good deterrent effect for drug abuse and detection and is sufficient to provide a reasonable measurement of the extent of drug abuse by licensee employees. Those programs had sample sizes that varied from less than 20% to greater than 100%, while the percent of positive drug test results remained essentially constant at or below 1%. Thus, the deterrent effect is nominally the same across the range of the sample size. See coment #21 in Attachment B.

It should also be noted that since the inception of utility drug testing programs, the number of pre-badging positives has decreased while at the same time the concentration level at which a sample is deemed positive has been lowered.

Modifications should be made to the list of drugs to be screened ,

and the random test sample size based on experience gained, 4

the testing technology, and the number of positives identified  !

j during random testing. It makes no economic sense, nor does  !

it contributi 10 isfaty, to test for some specific drugs when '

after a significant number of tests few, if any, positives are found. Nor does it make economic sense to have high testing rates when the percentage of positives identified is very low. Such statistics should be used as the basis for modifying the list of drugs to be screened and the testing rate required.

Another consideration is the cost impact of the program. The l disruption and lost manpower / productivity resulting from the '

testing process is the most significant aspect of the cost. '

See comment !!! in this Attachment which describes the industry I concerns rdjarding the NRC's Draft Backfit Analysis. The Draft Backfit Analysis underestimated the cost to the industry  ;

by at least a factor of three. If a 300% testing rate were r required, there would be an additional three fold increase in  ;

srogram operating costs. The random test rate must be balanced setween the potential to achieve a greater level of deterrence l and the significantly higher costs associated with higher  ;

I test rates.

c

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DRAFT The proposed rule implies that nearly everyone (90%) should be tested each year. If the NRC concludes, based on the record, that it is necessary to test most of the personnel in the subject population at,least annually, then another test category could be created; this could be called

• Annual Unannounced Routine Testing." All persons in the population subject to the rule would then be tested on an unannounced basis once during the calendar year in addition to a smaller (e.g. 25%)

random sampling program.

Further, the rule should recognize that licensees should be able to establish more than one sample population. Large numbers of contractor personnel r.ecessary to the conduct of outages would ' spike' the average number of tests required in a given year, causing permanent licensee employees to be subjected to a much higher effective sample rate, with the concomitant greater negative effect on productivity and morale.

The licensee's sampling population must be able to be maintained separately from the contractor / vendor population; there should be separate but equivalent testing programs that can ensure that the 100% sample size is achieved.

The industry believes that a 25% per year test rate will produce an acceptable deterrence to drug abuse. We have suggested the program begin with a 100% rate because random drug testing is not currently being done by all licensees, and public concerns would also probably be satisfied with a 100% sample rate. It is anticipated that by aerforming a program reevaluation after three years, tie collective experience will support a test rate reduction from 100% to approximately 25%.

Discussion Ouestion 4:

Are there effective alternatives to the ' Mandatory Guidelines for Federal Workplace Drug Testing Programs' issued by the Department of Health and Human Services (DHHS) on April 11, 1988 (53 FR 11970) that the Commission should adopt as minimum standards for fitness-for duty programs at nuclear power plants?

Comment. The ' Mandatory Guidelines for Federal Workplace Drug Testing Programs' cannot be directly implemented for the nuclear power industry and snould not be adopted, per se, by the NRC. For example, it is not possible for a licensee to comply with the many requirements that require ' written approval of the Secretary." These federal guidelines have many such require-ments and features that are not directly applicable to nuclear power fitness-for duty programs. Applicable portions of the DHHS Guidelines should be extracted and tailored for the

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DRAFT specific conditions of the private sector and the nuclear  ;

power industry in particular. For example, paragraph 14, page  !

11974, of the DHHS Guidelines precludes any management official  !

being notified of a positive result until the "Medical Review i Officer has the opportunity to review the facts and circum- ,

tances and make a decision on the meaning of the test results." <

In the nuclear power industry, this requirement could result i in an individual remaining on the job, with unescorted access, ,

during the several days required to process, sail, test, and evaluate the sample after a positive drug test has been  :

determined by an onsite screening test. -

Secondly, the cutoff levels established in the DHHS Guidelines are not considered stringent enough for some drugs. Even  !

though the NRC proposed rule states that licensees, at their  !

discretion, may implement programs with more stringent standards (e.g. lower cutoff levels), implementation may be 'spossible. l For example, an individual could test positive for marijuana r metabolites at a licensee that imposes a more stringent standard l of 50 ng/ml. The lab result may well be negative because the [

certified laboratory's screen test cutoff by the OHHS Guidelines l would be 100 ng/ml and a confirmation test would not be  ;

performed if not found positive at that level or above.  !

Additionally, it should be anticipated that adoption by a  ;

licensee of standards stricter than the NRC sanctioned federal  ;

guidelines would be challenged in court. The result could be that a licensee would be in the awkward and untenable position l of being unable to act against an untrustworthy casual drug l abuser. That would undercut the "zero tolerance" premise of i the entire drug testing program.  !

One of the intended outcomes of the Fitness for Duty proposed I rule is consistency between licensee Fitness-for Duty Programs.

In order to accomplish this goal, each licensee should adopt the same cutoff levels, or be able to provide data based on l the mandated cutoff levels if the licensee chooses to adopt a l lower cutoff level. Almost all licensees that currently have  !

drug testing programs use stricter cutoff levels than the '

DHHS Guidelines, but not all use the same cutoff levels.

NUMARC proposes that the following drug testing cutoff levels be incorporated in the rule as being more representative of 1 industry programs and goals: j Substance Screen Cont 1 nation (i fna/mi) (na/ml)

Marijuana metabolites 50 15 Cocaine metabolites 300 50 ,

Opiates 300 300 t Phencyclidine (FCP) 25 25 l Amphatamines 300 300 l

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i

DRAFT Additionally, it should be made clear that licensees may conduct tests for barbiturates, benzodiazepine metabolites, methadone, methaqualone, and propoxyphene based on their geographic locale and/or specific law enforcement or drug counseling infors:Ation available concerning current prevalent drugs.

The following paragraphs are considered the only DHHS Guideline procedures / methodologies that are applicable to the nuclear power industry. These sections could be extracted, essentially verbatim (i.e., It may be necessary to make a few wording /

tenninology changes (e.g. modify "agency" terminology to be consistent with NRC terminology}L and placed in the NRC Fitness for-Duty rule:

2.2 Specimen Collection Procedures 2.4(g)(1)-(5) Reporting Results 2.7 Reporting and Review of Results The remainder of the DHHS Guidelines relate to laboratory certification procedures. Licensees that do onsite screening should be allowed to have positive samples sent directly to a laboratory for confirmation testing without requiring that an additional screening test be conducted by the laboratory. In addition, the laboratory should be required to conduct screening and confirmation tests to the cutoff levels specified by the i Itcensee.

Discussion Ouestion 5: '

Are there any additional quality control measures or appeal procedures that should be considered to protect the rights of individuals being tested to ensure that individuals are not misidentified in the process as drug users and to provide a mechanism to correct any errors?

Specifically, who should have access to knowledge of the results of unconfirmed initial test results (employee, immediate supervisor, higher managementlevels)? What procedures are necessary to assure appropriate i privacy? -

i Comment: There is; no substitute for a solid chain-of custody stocedure and clear, documented laboratory procedures. Once tie issue of reasonableness is resolysd by the issuance of the rule, challenges to the testing will Itkely focus orc the chain of-custody and laboratory procedures (both handling and accuracy).  !

These challenges will likely occur more frequently for cases involving drugs where interferences are elleged or where the i drug for which the individual tested positive is a component of a legal prescription drug or over the counter drug. In addition, a considerable number of appeals of opiate positive l

l

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DRAFT l test ~ *.hould be expected because of the commonly known and weli publicized true positives resulting from dietary consumption of legal substances (many comon foodstuffs contain poppy seeds) and the use of over the counter drugs. These appeal pricesses will be time consuming and expensive for the  ;

licensee.

Licensees who do onsite screening, where test results will be imediately available, should be able to deny access based on ,

the results of the screening test, with a final determination to be made based on the confirmation test. In cases of positive tests, it is impossible to keep the results completely confidential due to the noticeable absence of individuals who are denied access. However, senior station management, the imediate supervisor, and security must be made aware of the situation and further information dissemination is not '

necessary.

Senior station management must be aware of the situation and the particular circumstances to assure that proper procedures have been followed consistently, the rights of the employee and the company are protected, and that any appeals or legal challenges can be expeditiously handled.

The individual's supervisor must be the point of contact with the individual, since the supervisor is the person who routinely interfaces with the individual and is the person to whom the individual is responsible.

Security must be involved in order to revoke the access authorization, change key card access and any required locks,

and initiate any investigations which may be required. In the case of contract individuals, the centractor should also l

be notified of the reason for access denial. l l

l l

Beyond the above described personnel, the details (including  !

the individual's name) should only be released to the individual l j or his/her representative (s) as authorized by the individual L

, in writing. Procedures must be in place to ensure there is i t

no record or other residual effect that might result from an i unconfirmed positive screen.

l I

, Discussion Question 6:

Should the Comission provide general guidance on potential impairments  !

such as alcohol abuse and prescription drugs? How should such guidance l l be implemented in a fitness for duty program? Should any random testing  ;

program be expanded to encompass legal drugs and alcohol? If so, should '

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DRAFl 4

the response to a positiv6 test for alcohol be the same as for illegal drugs? What should the response be to a positive test for legal drugs? ,

J Comment: Licensees would normally perform alcohol testing coincident

with the occasions for urine sampling for drugs. Current industry guidance plus that to be provided by an EEI Guideline

, supplement (being developed) will .>e sufficient to manage the :

, issue and make further guidance from the NRC unnecessary. l l

Alcohol should-be included in the pre badging, randon, and for-cause testing programs. Prescription drugs should be  !

! addressed only generally, requiring individua s to notify  !

their supervisor if they are taking prescription drugs which I

, could affect their performance. Care should be taken in l 1

response to positive tests for legal drugs since the employee  :

i may be unaware of the effects or contents of the prescription l J drug and, if included in the testing program, the response t i should be based on medical advice and must not penalize the l employee unless he is abusing the legal / prescription drug.

l A cutoff level of 0.04% BAC should be established for alcohol,  !

but sanctions or other management actions taken based on test  ;

results are not necessarily the same as those that are  !

apprupriate for the use of illegal drugs. Licensees have  :

programs to deal with the alcohol issue and these will be  :

enhanced by the EE! Guideline supplement. If there is to be -

further regulatory requirements for alcohol, it should be l made a separate regulation. (See NUMARC comments in the letter j to Mr. Chilk and general coment #5 in Attachment A). l

! t j

Discussion Ouestion 7:  !

How long should a person be barred from performing activities within 1

the scope of the proposed rule following removal under the fitness for l I

duty policy and under what circumstances should reinstatement be allowed? (

. How long should records of this removal be retained to facilitate future employment decisions? ,

o Comment: Each incident has different circumstances associated with it  !

and should be evaluated accordingly. The licensee should be  !

} able to determine minimum requirements associated with the '

{ first positive test incidence when combined with an appropriate j

evaluation by qualified counselors, psychologists, or  ;

psychiatrists and with a clean drug test. The second incidence I of a positive test due to randon, for cause, or post accident i j testing would normally be expected to result in permanent  !

dental of access instead of the three-year period speciffed l

J  ;

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DRAF~

in the proposed rule. Anyone using, possessing, or selling drugs onsite should be permanently barred from access. The records should be retained long enough to ensure that they are available for any required background screening.

. Discussion Ouestion 8:

Are the categories of workers identified for testing appropriate, or is some other population necessary/ sufficient for safety?

Comument: No other categorias of personnel need be included. It is sufficient that anyone granted unescorted access to the protected area be included 1., the test program. Further, each licensee should establish programs to ensure that escorted access is not utilized to circumvent the pre badging drug testing program. Since most of the key TSC/ EOF personnel, particularly those in decision making positions, are granted unescorted access as a part of their normal duties, it is unnecessary and burdensome to expand the program to specifically create an additional category to cover TSC/ EOF personnel.

Further, non campany Emergency Planning personnel are not in decision making positions and should not be included in a licensee's program.The NRC should delete this additional, unnecessary requirement. In addition, the rule as drafted could oe open to varying interpretation of different inspectors and Itcensees as to the scope of personnel included in tie TSC/ EOF organizations who would be required to be included in the drug testing program,

! Discussion Ouestion 9:

Should training on the items covered under 3, 4, and 5 of 26.22(a) be provided to all employees covered under the rule so each employee can recognize drugs; indications of the use, sale, or possession of drugs; and impairment of a person cov6.ed under the rule and know what action to take?

Cosament: All employees should be generally aware of the fitness for duty program, the Employee Assistance Program, and actions to be taken by them if they suspect drug er alcohol abuse and/or discover material which may be related to drug or alcohol use on siti. Specific training on techniques for recognizing

. drugs and indications of the use, sale, or possession of drugs i or in behavioral observation techniques is unnecessary except for supervisory personnel as is currently being done in the 1

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DRAFT ;

industry. As discussed in comment #16 in Attachment B, additional training for escorts is not necessary, desirable, or justifiable.

Discussion Ouestion 10:

Finally, the Comission is especially interested in receiving cossments on the extent to which NRC regulations on fitless-for duty should address other regulated activities not currently within the scope of this proposed rule.

In the matter of requirements for fitness for-duty programs at nuclear power plants undergoing constNction and pre operational testing, the Comissi,,n requests views on: (1) the relative safety significance of the wide variety of specific construction steps and crafts involved, (2) the extent to which the controls described above do or do not tend to provide adequate identification or mitigation of individual failures in performance in these areas and, accordingly, (3) the nature and extent of any fitness for-duty program elements which should be applied to these activities. An example might be the welding of reactor primary system boundaries, structures and supports, and safety related systems, es opposed to balance of plant welding.

Cossnent: The scope of activities included in the rule is appropriate.

We do not believe that the rule should be expanded:

- beyond nuclear power reactors.

beyond unescorted access to protected areas, or to activities occurring prior to the establishment of the protected areas.

II. The following are responses to the NRC posed questions in the Appendix to the Document, page 36827, "Fitness for Duty Program Elements Not included in the Proposed 10CFR Part 26".

Aeeendix Ouestiga,.1:

Expand the scope of the rule to include other activities directly related to nuclear safety performed by licarsee and contractor personnel. This could include engineering and quality assurance activities performed outside a protected area and activities performed by escorted licensee or contractor personnel within a protected area which, if not properly performed, could contribute te facility conditions adverse to public or worker safety.

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DRAFT Comment: The rule should not be expanded because it adequately covers the workplace where plant safety can be directly affected.

Existing quality control and testing programs adequately cover this work. Specifically, the scope as proposed in the rule should be limited to personnel with batscorted access with some ,

provision (such as a three day limit on escorted access without a drug test) to prevent circumvention through the use of escorted access.

Annendir Duestion 2:

Require that licensees take specific measures to deter onsite sale, possession, or use of alcohol and drugs and to achieve early detection r should these problems exist.

Conseent: Program elements are currently in place to ensure effective t fitness-for duty program performance without specifying the additional measures identified. The suggested measures may be useful but should be left to the prerogative of utility managers who are accountable for enforcing the chosen measures  ;

to deter the sale, possession, or use of alcohol and drugs i onsite.

Aeoendix Ouestion 3:

The NRC developed a list of data that appear to be appropriate based

, upon informed reviews by appropriate professionals in other organizations.

To ensure consistency of data and to facilitate analysis, the draft t

form below could be utilized. The Commission seeks specific coments  ;

as to whether the data listed form a relevant basis for the evaluation '

of program performance and whether there are any other data which would be important in this regard.  ;

1 Comment: The fitness-for duty program performance data form proposed goes far beyond the content of the rule. The data required cannot be directly used to determine program performanca.  :

1 Performance analysis and measures of effectiveness are routinely t done by licensee managers as another aspect of plant management.

! It would be appropriate for NRC personnel to review the data i and management actions, but it is inappropriate for the NRC to direct this management effort. The data collected on Employee Assistance Program use is only an indicator of employee i awareness and acceptance of the Employee Assistance Program

! and is inappropriate to be used for other purposes.

l In general, it is the identification of an individual who ,

i caused a problem or could have potentially caused a problem i

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1 l

1 DRAFT

,' l and is discovered through law enforcement efforts, random i testing, for cause testing, or accident investigation that provides an indication that the program is doing what it is  ;

designed to do. Identification through pre badging and randon  ;

testing and the usage of the Employee Assistance Program are  !

complementary in enabling potential problems to be recognized '

and indicate that the program is achieving its intended goal. >

4 High numbers of pre badging test results and EAP usage would l be an erroneous measure of a licensee's perfomance.

i I

This subject is further discussed in consent #39 in Attachment B. j i

!!!. The following is the response to the NRC query on application of the l j backfit rule to the rulemaking of the proposed 10 CFR Part 26:  !

Comment: We do not believe the proposed rule is indispensable to provide

adequate protection to the public health and safety. We have l 1 stated in our general comments that it will be an appropriate  ;

i and helpful addition to current nuclear power industry fitness-  !'

J for duty practices.

i The Draft Backfit Analysis significantly underestimates the  ;

costs of implementation. For example, the cost of random testing does not include any costs for the added staff needed  !

, to administer that program, assumes only one hour for initial '

training (experience shows this takes on the order of four ,

i hours), and assumes refresher training could be included in I j general employee training at no cost (in fact it would require l

about a two hour segment). Additional cost considerations i j

that are not adequately addressed in the statement include:  :

I - Lost work time should be expected to average one and one l half (1 1/2) hours vice the 30 minutes specified.  ;

- Drug testing program costs that meet the quality control requirements of the DHHS Guidelines will cost more than i estimated by a factor of three (3) based on the limited

! experience of a few licensees to date. l 1 .

! - Any imposed tracking system costs have not been addressed.

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II. The followine is the rosnonse to the NRC 'ouery on annlication of the backfit rule to the ru' amaiina of the cronosed 10 CFR Part 26:

Comment: We do not believe the rule in question is necessary to provide adequate protection to the health and safety to the public but have stated in our general comments that it will be a beneficial addition ta current nuclear power industry fitness for duty practices.

l The Value Impact statement generally underestimates the costs of implementation. For example, the cost of random testing does not include any costs 'or the added staff

needed to administer that program, assumes only one hour

for initial training (ex;,erience shows this takes at least four hours), and assumes refresher training could be included in general employee training at no cost (requires about a two hour segment). Additional cost j considerations that are not adequately addressed in the i

statement include:

Lost work time averages one and one half (11/2) i hours vice the 30 minutes specified, t

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Drug testing program costs that meet the quality

control requirements of the DHHS Guidelines will j

cost more than estimated by a factor of three (3) based on the Itaited experience of a few licensees.

j Any imposed tracking system costs have not been addressed.

j Note: Any other questions posed and not responded to herein does not i imply disinterest in the question but a lack of time to review the

) document carefully.

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Attachm:nt 2 i DETROIT EDISON COMPANY '

PROPOSED FITNESS FOR DUTY RULE COMMENTS NOVEMBER,1944 SECTION COMMENTS 26.2 The Detroit Edison Company believes that the NRC within the '

scope of the proposed rule, needs to clearly define which parts  ;

of the rule apply to employes, contractors, or both personnel classifications. The current scops would imply ALL persons are covered under the rule requirements, but the body of the rule segregates and allows for differing treatment between licensee employes and contractor personnel.

26.10 (a) Detroit Edison Company believes that the general performance [

objective is too broad in that it covers any substance, LEGAL l or ILLEGAL drugs, mental or physical impairments from any I cause, etc. However, the rule itself really only addresses illegal t drugs. Detroit Edison Company recommends either a f re-wording of this performance objective to limit it to, illegal ,

drugs or otherwise address in depth within the body of the rule i impairments caused by other factors.

26.20 (a) Detroit Edison believes that as written, this portion of the rule, l requires the licensee to develop policies and procedures to  !

addrest a!! drugs (legal, illegal, or alcohol), but the rule falls to !

clearly provide specific criteria to be met when testing for legal drug use or alcohol uss. '

26.21 (a) (2) and (3) Detroit Edison Company believes these portions of the policy, Communications and Awareness Training section of the rule are i already addressed by sub-paragraph (1) and (5) of the same section. l L

i 26.21 (b) Detroit Edison Company believes that annual refresher tra6ning is imperative for an effective program. Coupled with an i

effective indicator program, the refresher training is a timely

[

means of alerting affected persons to change in program policy or modus operandl of the drug culture. I l

I 26.22 (a) (3) Detroit Edison Company recommends that this section be  !

revised and limited to recognizing drugs and the indications of  !

the use of drugs. Teaching supervisors and managers the fine  !

art of detecting the sale of or possession of illegal substances l Is extremely dangerous and should be left to professionallaw I enforcement agencies.

Attachment 2 C ntinued 26.22 (b) Detroit Edison Compar*.y believes that escorts are already trained under the provisions of Section 26.21 of this part, and therefore this section is redundant, and should be omitted.

26.23 and 26.23 (a) Detroit Edison believes that the proposed rule is not clear as to what portions of the licensee's Fitness for Duty Program, the contractor must adhero to, and if a contractor develops a separate program, whether or not it must be equivalent to ali  !

portions of the licensees program. Further, Detroit Edison believes that contractors need only comply with the screening portions of the Fitness for Duty Program. Other aspects of this  :

rule, i.e. EAP Program, rehabilitation, appeals, etc., should be left i to the contractor's discretion.

26.24 (a) (1) Detroit Edison Company currently satects (i) and (ii) personnel at an annual rate equivalent to 100%. The analysis of monthly / quarterly data for a period of two (2) years has t been undertaken. There has been relatively constant proportion l l of the population (<.5%) that has been detected with illegal drugs throughout the life of our prcgram.

26.24 (a) (3) Detroit Edison Company believes that the proposed text is adequate. '

26.24 (b) Detroit Edison Company believes that the Department of Health l and Human Services guidelines are too restrictive wh4n applied to a licensee Fitness for Duty program. Specifically: i t

i o that state certification programs for laboratories are adequate to assure and effective program. Forcing ,

Department of Health and Human Services standards [

upon laboratories ww use would cause them to resist -

j Department of Health and Human Services certification  ;

as being costly, and the availability of otherwise l qualified laboratories would be greatly reduced, i

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o that the rule conflicts with Department of Health and .

Human Services guidelines in that if a licensee desired i to test for additional substances, the Department of ,

Health and Human Services would have to spprove the l test procedure, and cut-oN ievel in writing, prior to the  !

I tests being conducted. This would be unduly burdensome, 26.24 (e) Referencing the Department of Health and Human Services certification of laboratories, Detroit Edison believes the j requirements of Department of Health and Human Services l

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Attachm:nt 2 Continued guidelines, Section 2.4, i.e. blind sampling rate, backup power supply will cause smaller cortract laboratories to resist the Department of Health and Human Services certification. -

Additionally, the requirement to perform the initial screening and the confirmatory test at the same loca:lon may cause smaller testing facilities to discontinue drug screening for the nuclear power industry. At the present time Detroit Edison Company uses the split sample technique. When the initial positive on the EMIT / TLC occurrs the lab forwards a portion of '

the sample to another independent lab for a confirmatory test. 2 We believe that this process avoids lab bias concerns. We ,

recommend that portion of the Department of Health and Human Services guidelines not be included in the final rule. '

26.27 (b) (1) Detroit Edison believes that the mandatory 14 days removal from site undermines effective procedures currently in effect.

These procedures rely upon medical expertise to certify rehabilitation, and responsible site management to verify that the person is not a security risk. Site policles should effectively define these processes to be consistent with the business needs of each licensee.

26.27 (e) (suggested) Detroit Edison Company would propose a new sub-paragraph

' (e) stating, "Personnel subject to testing under this part who are legitimately away from the work place, i.e. vacation, company travel, etc., shall be tested upon return to work".

1 Detroit Edison Company believes that unescorted access does not need to be suspended if the employe participates in the testing program upon return to work.

26.28 Detroit Edison Company believes that reference to grievance review procedures as the appeals process should be eliminated

)

' from the final rule. Many licensees have other processess equally effective and the section overlooks those employes not covered by collective bargaining agreements. A single appeals system to establish consistency within each licensee's i

procedure is needed.

4 26.80 (a) Detroit Edison Company believes that program audits for j

compliance are needed every three (3) years, or at a time frame equal to the audit of Access Authorization Program when i

published, so long as effective controls to monitor program effectiveness are in place.

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i ATTACHMENT 3 COMMENTS ON FITNESS FOR DUTY OUESTIONS CONTAINED IN DISCUSSION OF THE PROPOSED RULE AS PUBLISHED IN THE FEDERAL REGISTER, SEPTEMBER 22,1984 i

r The following comments are provided by Mr. Mahmud U. Syed, M.D., Medical Director, Detroit Edison Company, i

Page 36796 Regarding EAP and Training Maintenance of an EAP and training of individuals should be left to licensee discretion so that programs can be designed to meet the individual utility needs (not all parts of the Fitness for Duty Program are regulated or mandated entirely by the Nuclear Regulatcry Commission (NRC)). '

Page 36796 Regarding Data for Evaluation of Program Performance i

The items innumerated on page 36827 and 36828 (third column) need not be included as rule  !

making, but as recommendations. This information should be maintained by the licensee in order for the licensee to determine the affectiveness of their program.

l Page 36796 Regarding Random Rates and Time Taken for Drug Screens NRC Chairman's ideas about having 300% testing is indeed meritorious in the sense that actual testing would be enhanced. However,it appears to us that greater deterrent is really perceived testing even at 100%. As a matter of fact, augmenting the percentage to 300% or even well above that would not absolutely create fool-proof, ideal circumstances to ensure total freedom from substances in a workplace unless the private sector is not only will'ng to but almost coerced into spending sizeable amounts of their revenues to conduct tnis kind of effort. It is understood that repeated drug screening for a given employe would clearly be perceived as a demoralizing nuisance, perhaps leading tu disloyalty and other stress related syndromes.

It takes a total of ten minutes to collect a drug screen through the Fermi system and an estimated additional fifteen minutes to process the resulting negative drug screen paperwork results, including the staff physician's review and signature, inputting the information into the computer, distributing and filing the necessary paperwork, etc.

The above reflects absolute ' time' only in a free flowing, uncomplicated system, i.e. When the only Irvolvement facing the medical team at a a given time is to interpret drug screens.

Additionally, costs of the employe productivity loss, impact on work, etc., would greatly increase the 'r sal

• costs.

Pagt 36796 Regarding Practical Alternatives to Random Testing Not Already Discussed in the Federal Register Notice At this point, the answer is 'no',

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i ATTACHMENT 3 CONTINUED Page 36796 Regarding What Practical Alternatives, Not Already Discussed in the Federal Register Notice Could Be Used to Determine Physical and Mental Impairment in order to ascertain physical and mental impairment a medical examination by a licensed doctor would be almost invariably required in order to stand up under legal scrutiny.

Page 36796 Regarding The Two Random Rates Discussed in the Proposed Rule and Alternative Rates that Should Be Considered by The Commission The current Detroit Edison program described in attachment 2 is a suitable alternative to those suggested in the proposed rule. We find that the 100% rate is effective and well accepted by the employe population. ,

Page 36796 Regarding Effective Alternativa. .., the Mandatory Guidelines for Federal Workplace Drug Testing Programs that Could Serve as Minimum Standards I support the comments addressed in attachment 2.

Page 36796 Regarding Additional Quality Control Measures The use of a split sample would provide additional quality control measures. The medical staff should have knowledge of unconfirmed initial tests. When the tests are confirmed, the fact that a person is not medically certifiable can be transtmtted to appropriate management.

Page 36796 Regarding General Guidance on Pctential impairment Such as Alcohol Abuse and Prescription Drugs I

Alcohol use and abuse of prescription drugs compromises Fitness for Duty. These should be included. The Medical Director will determine guidance. The response for abuse of alcohol should be the same as the misuse of prescription drugs at Dwtroit Edison.

The drug screening program at Detroit Edison lacludes alcohol and prescription drugs as determined by the Medical Director. The medical staff certainly uses professional judger.ient in medical evaluation of the employs with respect to Fitness for Duty, This evaluation will be arrived at for legitimate use or misuse of non-prescription drugs and other factors, i.e. fatigue, physical and mental stress, etc. These drug screens, over and above these designated by the HHS, do not need to be mandated but determined by the licensees.

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ATTACHMENT 3 CONTINUED Page 367g6 Regarding How Long a Person Should be garred From l Performing Activities Following Removal Under the Fitness for Duty Polley and Under What Circumstances Should Reinstatement go Allowed i

A person should be barred from performing activities following removal under the Fitness for '

Duty policy until the Medical Department la satisfied that those conditions which ctused this '

person to be barred are no longer present, For the emotionally impaired person, this might include documentation from the person's ,

attending physician / psychiatrist whi(h is acceptable to the Company's Medical Director or 4 designates, in addition, the following may be included on a report from the outside physician / psychiatrist: (1) the condition is in remission:(2) that the prognosis or continued ,

stability is excellent; (3) no medications are being taken which would interfere in any way with

their job performanca or ability to perform in a safe fashion.

For the substance abusing person, this would include all of the above requirements, as well as the following. The person must have a negative drug screen prior to returning to duty and continue to have negative drug screens while in the recall program (unannounced test'ng) to verify abstinence. '

i Page 36423 Regarding General Categories of Workers

-l The general categories of workers, i.e. those granted unescorted access is a*,,propriate.

1 i Page 36425 Regarding information Provided i 1

Information should be provihd to all employes cover 3d under the rule so that they understand '

I their responsibilities. In depth training at a time of budgetary constraints would be costly.

I Training should be restricted to firPt-line supervisors and above at this time because of i l

' budgetary constraints and other factors. EAP group in collaboration with the medical staff being l more conversant with the fundamental elements of Fitness for Duty Program should have a '

greater, in depth involvement in such training sessions. The training sessions need to be

, enhare:ed in their scope at appropriate levels.  !

Applicant Testing Statistics Statistics for pre-employment testing are attached from June,1984 to September,1988.

• l Regarding Contract Personnel Hav'ng an EAP Program i i  !

! All contractor personnel should have EAP services. Ideally, this service should be provided by i

Detroit Edison's EAP as it would insure the same quality of service to all employes at Formt 2. '

EAP services would include assessment and referral as well as training (behavioral reliability) of 4

contractor supervisory personnel.

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i ATTACHMENT 3 CONTINUED Many contractors do not have access to any EAP services especially contractors with a small work force. Of those contractors who offer EAP services to their Fermi 2 employet very few have their own EAP. The majority contract our for this service. A recent survey revealed the following. Contractors at Fermi 2 were surveyed as to whether their company provides EAP services to its employes. Of the thirty-three companies responding to the inquiry:

c. Seven companies have formal *in-house

• EAP.

b. Three companies do not have an EAP but do have a contact person with their company who can provide assessment and referral service,

c. Five companies contract out for EAP.

d. Eighteen companies provide no EAP services, whatsoever.

Pitfalls of H.H.S. Guidelines A pitfall of the H H.S. guidelines is the implanlentation of a blind sampling program in the volume suggested. Bilnd sampling required by the regulations would require contracting the service.

Preliminary investigations show a one hundred dollar per specimen charge for such a service.

The initial testing of the laboratory would require, at current testing rates of five thousand per year, that twenty-five hundred samples be sent in for blind testing at one hundred dollars a sample. Two hundred and fifty thousand dollars would be required for implementation.

The blind performance test portion of the H.H.S. guidelines requiring that quarterly samples I

be sent to a laboratory would be expensive to implement. Based on our current volume of five thousand specimens a year, one hundred and twenty-five samples would have tre be submitted per quarter at the rate of one hundred dollars per sample. Using a contractor, the cost yearly for this quarterly assessment would be fifty thousand dollars.

It is recommended that a lesser number of blind samples be required I.e. 50 a year.

l l Costs of Drug Screens Costs of testing per specimen are as follows at Detroit Edison:

i j EMIT screening $ 9.00 TLC 10.50 GCMS 60.00 Regarding Cut-Off Levels Regarding cut-off levels, guidelines set by HHS are appropriate as minimum rtandards. For obvious reasons alcohol must be included as one of the substances to be tested for. Detroit Edison's cut-off point is currently set at .06 or above.

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ATTACHMENT 3 CONTINUED Regarding Development of Treatment, Follow-Up and Future Employment Plans This should be dettermined by the Medical Director and EAP on a case by case basis depending on severity of Individual case, a

Regarding On-Site Lainoratories -

Such on-site laboratories in the State of Michigan would require to be licensed by the Michigan Department of Public Health. Altogether, maintenance of on-site laboratories for preliminary drug screening would be a more costly affalt as compared with contracting it out to a regular >

laboratory. In addition, matters of confidentiality, credibility of personnel, maintenance of equipment and a number of other factors would come into consideration not only by the licensing authorstles and the licensee but also by the employes and their unions, t

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