ML20033G887

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Staff Requirements Memo Re Commission Approval of Proposed Rev to 10CFR55 on fitness-for-duty Program (SECY-90-54) Subj to Incorporation of Encl Editorial Comments
ML20033G887
Person / Time
Issue date: 03/13/1990
From: Chilk S
NRC OFFICE OF THE SECRETARY (SECY)
To: Taylor J
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
References
REF-10CFR9.7 NUDOCS 9004120304
Download: ML20033G887 (9)


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MEMORANDUM FOR:

James M. Taylor Executive Director for Operations FROM:

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m el J. Chilk, Secretary SUILTECT:

SECY-90 PROPOSED REVISION OF 10 CFR PART 55 TO REQUIRE COMPLIANCE WITH FITNESS-FOR-DUTY PROGRAMS AND CONFORMING MODIFICATION TO COMMISSION'S ENFORCEMENT POLICY This is to advise you that the' Commission (with all Commissioners agreeing) has approved the proposed rule subject to incorporating the attached editorial comments.

The Federal Register notice should be revised as noted, reviewed by the Regulatory Publications Branch, ADM, and returned for signature and publication.

(EDO)

(SECY SUSPENSE:

4/9/90) cc:

Chairman Carr Commissioner Roberts Commissioner Rogers Commissioner Curtiss Commissioner Remick OGC i

NOTE:

THIS SRM AND THE SUBJECT SECY PAPER WILL BE MADE PUBLICLY AVAILABLE UPON PUBLICATION OF THE FEDERAL ' REGISTER NOTICE.

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k k 9o04120304 900313 PDR 10CFR PT9.7 PDC

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Nuclear Regulatory Comission 10 CFR Part 55 Operators' Licenses j

Agency:

Nuclear Regulatory Comission.

Action:

Proposed Rule.

Sumary: The Nuclear Regulatory Comission proposes to amend its regulations f

so that the conditions and cutoff levels established pursuant to 10 CFR Part i

26 " Fitness-for-Duty Programs," become applicable to licensed operators as a condition of their license. The proposed rule will provide a basis for taking enforcement actions against licensed operators who use drugs or l

alcohol in a nanner that would exceed the cutoff levels contained in the Fitness-for-Duty rule, 10 CFR Part P6, who are under the influence of any prescription or over-the-counter drug which could adversely affect his or her ability to safely and competently perform licensed duties, or who sell, use, or possess illegal drugs.

i On June 7,1989, the Comission issued a new part to its regulations, Part 26, "Fitriess-for-Duty Programs " requiring iacility' licensees ~ authorized to operate nuclear power reactors to implement a Fitness-for-Duty Program that would provide reasonable assurance that nuclear power plant personnel are not under the influence of any prescription, over-the-counter or illegal substance that in any way would adversely affect their ability to saf ely perform their job duties.

l The proposed revision to Part 55 will assure a safe operational environment for the perfortrance of all licensed activities under that part by providing a i

clear understanding to licensed operators of the severity of violating reovirements governing drug and alcohol use and of the impact of substance abuse.

Dates: The cement period expires [ insert date 60 days from date of Federal Registerpublication].

Coments received after this date will.be considered if it is practicable to do so, but assurance of consideration can be given i

only for comments filed on or before that date.

I Addresses: Submit written coments to:

Secretary, U.S. Nuclear Regulatory Comission, Washington, DC 20555, ATTN:

Docketing and Services Branch. Hand deliver coments to Docketing and Services Branch. One White Flint North,11555 Rockville Pike, Rockville, MD, between 8:15 a.m. and 5:00 p.m.

Examine coments received at:

The NRC Pub Mc Document Room, 2120 L Street NW.,

Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Kenneth E. Perkins, Jr., Chief, Operator j

Licensing Branch, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Comission, Washington, DC 20555, Telephone:

(301) 492-1031.

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' SUPPLEMENTARY INFORMATION !

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The NucTear Regulatory Comission has issued its regulations to require i

s licensees authorized to construct or operate nuclear power reactors to implement a fitness-for-duty program.

The general objective of this program is to provide reasonable assurance that nuclear power plant personnel will t

perform their tasks in a reliable and trustworthy manner, and not under the i

l influence of any prescription, over-the-counter or illegal substance which in -

any way adversely affects their ability to saf ely and competently perform their duties. A fitness-for-duty program developed under the requirements of this rule is intended to create ap environment which is free of drugs and the effects j

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1 The Comission is now proposing to add specific conditions to operator licenses issued under 10 CFR Part 55 to make fitness-for-du}y requirements directly; i applicable to such operators e...;h : n...own v' i e.....~ As pointed out in

' t the supplementary information accompanying the promulgation of 10 CFR Part 26, l

(54 FR 24468), the scientific evidence is conclusive that significant deciements in cognitive and physical task performance result from intoxication i

due to illicit crug abuse, as well as the use and misuse of prescription and over-the-counter drugs. Given the addictive and impairing nature of certain drugs, while recognizing that the presence of drug metabolites does not f7,'

y necessarily re' ate directly to a' current impaired state, the presence of drugst. $,,

does strongly suggest the likelihood of past, present, or future impairment affecting job activities. More specifically, the Comission stated that 3

" Individuals who are not reliable and trustworthy, under the influence of any i

substance, or mentally or physically impaired in any vay that adversely effects their ability to safely and competently perform their duties, shall-not be 1 censed or permitted to perform responsible health and safety functions. "

ee 54 FR 24468at 244931.s Because there is an underlying assumption that p pErators will abide by the licensee's policies and procedures, any involvement with illegal drugs, whether on site or off site w show that the operator

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cannot be relied upon to obey y-m ur g F.. C -%;A*5 that the individual may not s rupulously follow igorous procedural requirements with the integrity require n the nuclear power dustry to assure public health 1% mp mea d cQ b dw)

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The Comission considers unimpaired job performance by.each licensed Operator or Senior Operator vital in assuring safe facility operation.

The NRC routinely denies Part 55 license applications or conditions operator and senior o>erator licenses if the applicant or licensee's medical condition or general 1ealth does not meet the minimum standards taquired for safe an Further un 955.25 4 10 CF C,'

c74/g performance of assigned job duties.

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"= xe develops, W[ndur p term off ee,de1 cense. a oh 4%.

1 condition that causes the

___ to fail to meet the requirements for medicalt %

J N(oF fitness, the facility licensee s % notify the NRC.

Such conditions may result in the individua1N, license being modified, suspended, or revoked.

ine power reactor facility ' licensee is further required, underJ26.20(a) eili30

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fitness-for-duty requirements for abuse of prescription and over-the-counter C

drugs and other factors that could affect fitness-for-duty such as mental L

stress, fatigue and illness.

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To be consistent with this proposed rule, the Connission expects that th I

policies and procedures will require the Part 55 licensee to rep rt the use of l

such drugs for evaluation by the medical review officer, The use of alcohol and drugs can directly impair job causes of impairment include use of prescription and over performance. Other l

emotional and mental stress, fatigue, illness, and physical and psych impairments. The effects of alcohol, which is a drug, are well known and l

docuranted and therefore, are not repeated here. Drugs such as marijuana sedatives, hallucinogens, and high doses of stimulants could adversel 4

an employee's ability to correctly judge situations and make decisions-(NUREG/CR-3196, " Drug and Alcohol Abuse:

The Bases for Employee Assistance Programs in the Nuclear Industry," available from the National Technical Information Service). The greatest impairment occurs shortly af t I

3 abuse, and the negative short-term effects on human performence (er use or inclucing-1 can last for several hours or days. The proposed amend will establish a new condition of an operator's license which will prohibit i

conduct of littrsed duties while under the influence of alcohol or any i

prescription, over-the counter or ille affect performance of licensed duties. gal substance which would adversely

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be applicable to both power and non-power reactor licensed oper rulemaking is not intended to apply the provisions of 10 CFR Part 26 to This non-power facility licensees but to make it clear to all licensed reactor operators (power and non-powe,r) through a condition of their license that

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of drugs or alterc1 in any manner which cculd adversely affect performance of licensed duties will subject them to enforcement action.

1 As explained in the Comission's Enforcement Policy (see 53 FR 40027

%econcuctoftheindividualplacesinquestiontheNRC'sreas October 13,1988),

th assurance tht.t licensed activities will be properly conducted.

The Connission may take enforcement action for reascns that would warrant refusal to issue a license on an original application.

Accordingly, enforcement actior may be of sound judgment, Integrity, competence, fitness-for-d that may not necessarily be a violation of specific Comission requirements.

\\ M ivi s licensed un er 10 CFR WbD who"&e not~feli le and ]

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who have be ound, wh e employed a license facil y and having escorted acce., to have sed drugs o alcohol in l

M caus them to viol the cuto levels con ined in 10 R Par 26, wheth r manne which' (J

as result of te ing by th mploying fa.lity licen e, or a law forcement ag cy of the deral, Stat r local g rnment or by o er-

  1. y credible me t will r.o e permitted o perform nctions hat coul result' l

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  • health and safety o ne nublic or n m wni k,,.e

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%..L.A,,The Comession proposes to' amend Subpart F of 10 CFR7 art 55 to establish as a cerdition of an operator's license a provision precluding i

p performance of licensed duties while under the influence of drugs or alcohol in

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any manner which could adversely affect performance. The Comission further proposes to amend Subpart G of 10 CFR Part 55 to provide explicit additional i

notice of the terms an(conditions under which a license may be revoked, tunnanded or modified.*fThese provisions will apply to any Fitness-for-Duty program establisheo by a facility licensee, whether or not required by l

i Commission regulations, including programs which establish cutoff levels below those set by Appendix A, 10 CFR Part 26. The Commission notes, however, that it has the discretion to forego enforcement action against a licensed operator if i

the facility licensee established cutoff levels that are so low as to be unreasonable in terms of the uncertainties of. testing. The Commission has reserved the right to review facility licensee programs against the performance objectives of 10 CFR Part 26, which requires reasonable detection measures. The proposed rule is not intended to impose the provisions of 10 CFR Part 26 (Fitness-for-Duty) on non-power facility licensees, but is to 1

make compliance with the cutoff levels and the policy and procedures regarding the use of icgal drugs established pursuant to Part 26 a license condition for all Part 55 licensees.

Further, the proposed rule is not intended to apply enforcement sanctions against operators or senior operators for their proper s

use of legal over-the-counter or prescrip ion drugs, but to require the reporting X

of such drug usej @ r medical conditio requiring the use of drugs, to the facility licenseT in order for a medical review officer to determine the Ohnc #5 "M

f fitness for duty.

i When the amended rule becomes effective, licensed operators will be subject to notices of violation, civil penalties or orders for violation of this condition. Therefore, in aedition tc amending the regulations to establish the t

Part 55 licensee's obligations, the Comission intends to modify the NRC Enforcement Policy in conjunction with the final rulemaking. - It is the Comission's intention to modify the Enforcement Policy as follows:

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In cases involving a licensed operator's failure to meet applicable i

f urass-far-duty requirements (10 CFR 55.53(j)), the NRC may issue a notice of violation or a civil penalty to the Part 55 licensee, o suspend, modify or revoke the license.

These actions may be taken y l

th first time an individual who fails a drug or alcohol test, i.e.,

1 exceeds the cutof f levels of 10 CFR Part 26 or the JeetlitWg A!4 -

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In addition, the NRC will, at a minimum, issue an order k levels if lower.

I to suspend the Part 55 license for up to 3 years the second time the individual exceeds those cutoff levels.

In the event there are less than 3 years remaining in the tern of the individual license, NRC may consider 4

not renewing the individual license or issuance of a'new license until the 3 year period is completed. The NRC will issue an order to revoke the Part 55 license the third time an individual exceeds those cutoff levels.

A licensed operator or applicant who refuses to participate in the drug and alcohol testing programs esteb11shed by the facility licensee or who is involved in the sale, use, or possession of an ille al drua may be

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L sub.iect to license suspension, revocation, or denial, n acoition, K

[ positive test results ano f ailures to participate in rug and alcohol s k

L testing programs may be considered in making decisions concerning renewal of a Part 55 license.

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To assist in determining the severity levels of potential violations, Supplement I would be modified to provide an example at Severity Level I of a licensed operator performing duties while unfit and an example at Severity Level 111 of a licensed operator's initial failure of a drug or alcohol test.

Environmental Impact:

Categorical Exclusion The NRC has determined that this proposed rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(1). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed rule.

Paperwork Reduction Review This proposed rule contains no information collection requirements and, therefore, is not' subject to the requirements of the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).

REGULATORY ANALYSIS The regulations in 10. CFR P6rt 55 establish procedures and criteria for the issuance of licenses to Operators and Senior Operators of utilization facilities licensed pursuant to the Atomic Energy Act of 1954, as amended, or Section 202 of the Energy Reorganization Act of 1974, as amended, and 10 CFR Part 50. These established procedures provide for the terms and conditions upon which the Commission will issue, modify, maintain, and renew Operator and

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Senior Operator licenses.

SubpartFofPart55,under555.53("ConcitionsofLicenses"),setsforth the requirements and conditions for the maintenance of Operator and Senior Operator licenses.

AmendingSubpartFtoprohibjfperformanceoflicenseddutieswhileunder the influence of drugs or alcohol a manner which could adversly affect safe and competent performance of licensed duties will provide notice to licersed individuals of the gravity of violating these requirements and will provide assurance that nuclear facilities are being operated safely.

Amending Subpart G to provide explicit additional notice to licensed 1

operators of the terms and conditions under which a license may be revoked, suspended or modified will describe circumstances in which enfnrcement action will be taken and the penalty for violating the conditions or cutoff levels contaired in 10 CFR part 26.

REGULATORY FLEXIBILITY CERTIFICATION The proposed rule will not have a significant economic impact upon a substantial number of small entities. Many operatur license applicants or operator licensees fall vithin the definition of small businesses found in 1

-6 Secticn 34 of the Small Business Act, 15 U.S.C. 632, or the Small Business Size Standards set out in regulations issued by the Small Business Administration at 13 CFR Part 121 or the NRC's size standards published December 9,1985 (50 FR 50241).

The proposed rule will only serve to provide notice to licensed individuals of the conditions under which they are expected to perform their licensed duties.

Thus, in accordance with the Regulatory Flexibility Act' 5 U.S.C. 605(b),

theNRCherebycertifiesthatthisrule,ifpromulgated,willnothavea significant economic impact upon a substantial number of small entities.

BACKFIT ANALYSIS This proposed rule does not modify or add to systems, structures, components, or design of a facility; the design approval or manufacturing license for a nuclear reactor facility; or the procedures or organization required to design, construct, or cperate a facility. Accordingly, no backfit analysis pursuant to 10 CFR 50.109(c) is required for this proposea rule.

List of Subjects in 10 CFR Part 55 Manpower training programs, Nucicar power plants and reactors, Penalty, P,eporting and record-teeping requirements

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For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Part 55.

pART 55 - OPERATORS' LICENSES 1.

The authority citation for Part 55 is revised to read as follows:

AUTHORITY:

Sec. 107, 161, 182, 68 Stat. 939, 946 953, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2137, 2201, 2232,(2282); secs. 201, as amended, 202, 88 Stat. 1242, as amended, i

1244 42 U.S.C. 5841, 5842).

Sections 55.41, 55.43, 55.45 and 55.59 also issued under sec. 306, Pub. L.97-425, 96 Stat. 2262 (42 U.S.C. 10226). Section 55.61 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237).

For the pur (42 U.S.C. 2273) poses of sec. 223, 68 Stat. 958, as amended i

il 55.3, 55.21, 55.53(j), 55.49 and 55.53 are i

issued under sec. 1611, 68 Stat. 949,'as amended (42 U.S.C. 2201(1));

i and il 55.9, 55.23, 55.25, and 55.53(f) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

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In 555.53, paragraph (

paragraphs (j) and (k)j) is redesignated as paragraph (1) and new 2.

are added to read as follows:

55.53 Conditions of licenses.

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(j) The licensee shall no use alcohol within the protected area of power reactors, or th ontrolled access area of.non-power 1

reactors. The licensee shall not use, possess, or sell any j

(11egal drugs.

The licensee shall not perform activities authorized by a license issued under-this part while'under the r

influence of alcohol or any prescription, over-the-counter or illegal substance which could adversely affect his or her ability to. safely and competently perfonn his or her licensed duties.

For the purpose of this subsection, with respect to elechol and illegal' drugs, the term "under the influence" means the licensee exceeded the lower of the cutoff lesels for drugs or alcohol contained in Appendix A Part 26, of this chapter, or as established by the facility licensee. With respect to prescription and over-the-counter drugs, the term "under the influence" means the licensee could be mentally or' physically impaired, as-determined by a medical review officer, in such a manner as to adversely affect his on her ability to. safely and competently perform licensed duties.

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( k) The licensee at power reactors shall participatt in the drug and alechol testing programs established pursuant to 10 CFR part 26. The licensee at non-power reactors shall participate in any drug and alcohol testing program that may be established for that non-power facility.

3.

In $55.61, a new paragraph (b)(5) is added to read as follows:

i 55.61 Modification and revocation of licenses.

l (b)(5) For the sale, use or possession of illegal drugs, or refusal to participate in the facility drug and alcohol testing program, or a confirmed positive test for drugs, drug metabolites or alcohol in 1

L violation of the conditions and cutoff levels established by section 55.53(j)ofthispart,oruseofalcoholwithintheprotectedarea of power reactors or the controlled access area of non-power reactors, or a determination of unfitness for scheduled work due to the consumption of alcohol.

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i 8-i Dated at Rockville, Maryland, this day of For the Nuclear Regulatory Comission, Samuel J. ch11k I

Secretary of the Commission.

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