ML20042F732

Proposed Rule 10CFR55, Operators Licenses. Rule Would Provide Basis for Taking Enforcement Actions Against Licensed Operators Who Use Drugs or Alcohol in Manner Exceeding Cutoff Levels Contained in fitness-for-duty Rule

ML20042F732
Person / Time
Issue date:	04/11/1990
From:	Chilk S NRC OFFICE OF THE SECRETARY (SECY)
To:
References
FRN-55FR14288, RULE-PR-55 PR-900411, NUDOCS 9005090319
Download: ML20042F732 (14)

Text

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'90 APR 13 P6 :37 NUCLEAR REGULATORY COMMISSION 10 CFR PART 55 RIN 3150-AD 55 l'

Operators' Licenses AGENCY:

Nuclear Regulatory Commission.

ACTION:

Proposed Rule.

SUMMARY

The Nuclear Regulatory Comission proposes to amend its regulations specifying that the conditions and cutoff levels established pursuant to the Comission's " Fitness-for-Duty Programs," are applicable to licensed operators as a condition of their license.

The proposed rule would provide a basis for taking enforcement actions against licensed operators who use drugs or alcohol in a manner that would exceed the cutoff levels contained in the Fitness-for-Duty rule, 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.

The proposed rule would assure a safe operational environment for the perfor-mance of all licensed activities by prov.iding a clear understanding to licensed operaturs of the severity of violating requirements governing drug and alcohol use and of the impact of substance abuse.

DATES: The comment period expires July 2,1990.

Comments received after this date will be considered if it is practicable to do so, but assurance of consideration can be given only for comments filed on or before that date.

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').Np 9005090319 900411 PDR PR SS 55FR14288 PDR j

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-2 ADDRESSES:

Submit written comments to:. Secretary, U.S. Nuclear Regulatory.

Commission, Washington, DC 20555 ATTH:

Docketing and Services Branch.

Deliver comments to Docketing and Services Branch, One White Flint North,11555 Rockv'ille Pike, Rockville, MD, between 7:45 am and 4:15 pm Federal Workdays.

Examine comments received at:

The NRC Public' Document Room,- 2120 L Street NW.

Lower Level, Washington, DC.

20055.

FOR FURTHER INFORMATION CONTACT:Kenneth E. Perkins', Jr., Chief, Operator Licensing Branch, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone:

(301) 492-1031.

SUPPLEMENTARY INFORMATION:

BACKGROUND On June 7,1989 (54 FR 24468) -the Nuclear Regulatory Commission-issued.

a new 10 CFR Part 26 entitled Fitness-for.-Duty Program to require licensees-autherized 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 perform their tasks in a reliable and trustworthy manner, and not under the influence of any prescription, over-the-counter or illegal substance which in any way adversely affects their ability to safely and competently perform their duties.

A fitness-for-duty program developed under the requirements of this rule is

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intended to create 1a work environment which is free of drugs and alcohol and the effects of these substances.

P The Commission is now proposing to add specific conditions to operator i

licenses issued under 10 CFR Part 55 to make fitness-for-duty requirements

!y directly applicable to.these operators.

As pointed out ih the supplementary-

I information accompanying the promulgation of 10 CFR Part 26, the scientific r

evidence is conclusive that significant decrements in cognitivefand' physical I

task performance result from intoxication due to illicit drug 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 necessarily relate directly to-a. current impaired state, the presence of drugs in an individual's system does strongly suggest the likelihood of past, present, or future impairment affecting job activities.

More specifically, the Commission stated that " Individuals who are not reliable and trustworthy, under the influence of any substance, or mentally.

or physically impaired in any_way th.at a.d.versely affects_their ability to.

safely and competently perform their duties, shall not be licensed or permitted to perform responsible health and safety functions." - (See 54' FR 24468, June 7,

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1989).

Because there is an underlying assumption that operators will abide'by a

the licensee's policies and procedures, any. involvement with illegal ~ drugs, whether on site or off site, tends to show that the operator cannot be' relied upon to obey the requirements of the law and indicates that the individual may-

-l not scrupulously follow rigorous procedural requirements with the integrity i

required in the nuclear power industry to assure public health and safety.

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4 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 operator licenses if the applicant or licensee's medical condition or general health does not meet the minimum standards required for the safe perfomance of assigned job duties.

Further, under 10 CFR 555.25 if an operator develops, during the term of his or her license, a physical or mental condition that causes the operator to fail to meet the requirements for medical fitness, the facility licensee is required to notify the NRC.

These conditions may result in the individual operator's license being modified, suspended, or revoked.

The power reactor facility licensee is further required, under $26.20(a) to have written policies and procedures that address #itness-for-duty requirements for abuse of prescription and over-the-counter drugs and other factors that could affect fitness-for-duty such as mental stress, fatigue ar.d ill.>ss.

I To be consistent with this proposed rule, the Connission expects that these policies and procedures will require the. Part 55 licensee to report the..use of-

-J these drugs for evaluation by the medica 5 review officer.

The use of alconol and drugs can directly impair job performance.

Other causes of impairment include use of prescription and over-the-counter medications.

3 emotional and raental stress, fatigue, illness, and physical and psychological I

impairments.

The effects of alcohol, which is a drug, are well known and i

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documented and, therefore, are not repeated here. Drugs such as marijuana, sedatives, hallucinogens, and high doses of stimulants could adversely affect an employee's ability to correctly judge situations and make decisions (NUREG/CR-3196,"DrugandAlcot.olAbuse:

The Bu es for Employee Assistance Programs in the Nuclear Industry, available from the National Technical InformationService).

The greatest impairment occurs shortly after use or abuse, and the negative short-term offects on human performance (including subtle or marginal impairments that are difficult for a supervisor to detect) can last for several hours or days. The proposed amendment to 10 CFR Part 55 would establish a new condition of an operator's license which will prohibit conduct of licensed duties while under the influence of. alcohol or any prescription, over-the-counter or illegal substance which would adversely affect performance of licensed duties.

The proposed amendment would be applicable to both power and non-power reactor licensed operators.

This rulemaking is not intended to apply the provisions of 10 CFR Part 26 to non-power facility licensees, but to make it clear to all licensed reactor operators (power and non-power) through a condition of their.. license.that use of drugs or alcohol in eny manner which Ecolo adversely affect performance of licensed duties would aubject them to enforcement action.

As explained in the Commission's Enforcewnt Policy (see 53 FR 40027, October 13,1988), the Commission may take enforcement action where the conduct of the individual places in question the NRC's reasonable assurance that licensed activities will be properly conducted. The Connission may take

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enforcement action for reasons that 'would warrant refusal to issue a license on an original application.

Accordingly, enforcement action may be taken regarding matters that raise issues of trustworthiness, reliability, use of sound judgment, integrity, competence, fitness-for-duty,_or other matters.that may not necessarily be a violation of specific Comission requirements.

The Commission proposes to amena Subpart F of 10 CFR Part 55 to establish as a condition of an operator's license a provision precluding perforrance of =

licensed duties while under the influence of drugs or alcohol in any nanner which could adversely affect performance.

The Comission further proposes to amend Subpart G of 10 CFR Part 55 to provide explicit additional notice of the terms and conditions under which a license may be revoked, suspended or l

modified.

In addition, positive test results and failures to participate in drug and alcohol testing programs may be considered in making decisions concerning renewal of a Part 55 license.

These provisions would apply to any Fitness-for-Duty program established by a facility licensee, whether or not required by Comission regulations,. including programs.which establish cutoff levels below those set by 10 CFR Part 26, Appendix A requirements.

Ihe Comission notes, however, that it has the discretion to forego enforcement action against a licensed operator if the facility licensee established cutoff levels that are so low as to be unreasonable in terms of the uncertainties of testing. The Comission 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 a

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the provisions of 10 CFR Part 26 (Fitoess-for-Duty) en non power facility, licensees, but is to make compliance with the cutoff levels ano the policy and procedures regarding the use of legal drugs established pursuant to 10 CFR-Part 26 a license condition for all 10 CFR Part 55 licensees. Further, the 1

proposed rule is not intenced to apply enforcement sanctions against operators or senior operators for their proper use of legal over-the-counter or prescrip-tion drugs, but to require the reporting of such drug use, or medical conditions requiring the use of drugs, to the facility licensee in order for a medical review officer to determine the operator'c fitness-for-duty, if the propose.1 rule is adopted as a final rule and becomes effective, licensed operators will be subject to notices of violation, civil penalties or orders for violation of this condition. Therefore, in addition to amending the regulations to establish the 10 CFR Part 55 licensee's obligations, the Commission intends to modify the llRC Enforcement Policy in r.onjunction with the final rule-

making, it is the Commission's intention to modify the Enforcement Policy as follows:

i in cases involving a licensed operator's failure to meet applicable fitness-for-duty requirements (10 CFR 55.53(j)), the NRC may issue a notice of violation or a civil penalty to the Part 55 licensee, or an order to suspend, modify or revoke the license. These actions may be taken the first time an individual who fails a drug or alcohol test, i.e.,

4 exceeds the cutoff levels of 10 CFR Part 26 or the facility licensee's I

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-8 cutoff levels if lower.

In addition, the NRC will, at a minimum, issue an order 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 term of the individual license, NRC may consider 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 established by the facility licensee or who is involved in the sale, use, or possession of an illegal drug may be subject to license suspension, revocation, or denial.

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

7 Environmental Impact: - Categorical Exclusion The NRC has determined that this propos3d 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.

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l l Paperwork Reduction Act Statement This proposed rule contains no infrmation 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 Part 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 Senior Operator licenses.

SubpartFofPart55,under.655.53_("ConditionsofLicenses"),-setsforth-the requirements and conditions for the maintenance of Operator and Senior Operator licenses.

This proposed rule only serves to notify the 10 CFR Part 55 operator and senior operator of the conditions they are required to comply with under Part 26, Fitness-for-Duty Program. A regulatory analysis for compliance with the conditions

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. and cut-off levels, that examines the costs and benefits of the alternatives considered by the Commission, has been prepared for the final rule resulting in the promulgation of Part 26 and is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, D.C.The Commission had previously requested public comment on the regulatory analysis as part of the rulemaking proceeding that resulted in the adoption of Part 26.

Regulatory Flexibility Certification The proposed rule will not have a significant economic impact upon a substant17.1 number of small entities.

Many operator license applicants or operator Itcensees fall witnin the definition of small businesses found in Section 34 of the Small Business Act, 15 U.S.C.-622, 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 _ qf. 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),

the NRC certifies that this rule,-if promulgated, will not have a significant economic 1;cpact upon a substantial number of small entities, i

. Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule, and therefore, that a backfit analysis is not required for this proposeo rule, because these amendments do not involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Part 55 Criminal penalty, Manpower training programs, Nuclear power plants and reactors, Reporting and recordkeeping requirements For the reasons set out in the preamble and under the authority of the l

Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1$74, 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 I

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

AUTHORITY:- Secs. 107, 161, 182, 68 Stat. 939, 948 953, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2137, 2201, 1

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.... 2232, 2282); secs. 201, as amended, 202, 88 Stat.1242, as amended, 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 purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.

2273); il 55.3, 55.21, 55,49 and 55.53 are issued under sec.1611, 68 Stet. 949, as amended (42 U.S.C. 2201(1)); and si 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 $55.53, paragraph (j) is redesignated as paragraph (1) and new

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paragraphs (j) and (k) are'added to read as follows:

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J 555.53 Conditions of licenses.

(j) The licensee shall not consume or ingest alcohol within the protected area of power reactors, or the controlled access area of non-power reactors.

The licensee shall not use, possess, or l

. sell any illegal drugs. The licensee shall not perform activities authorizeo by a license issued under this part while under the influence of alcohol or any prescription, over-the-counter or illegal substance which could adversely affect his or her ability to safely and competently perform his or her licensed duties.

For the purpose of this paragraph, with respect to alcohol and illegal drugs, the term "under the influence" means the licensee exceeded the lower of the cutoff levels for drugs or alcohol certained in 10 CFR Part 26, Appendix A, 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 or her ability to safely and competently perform licensed duties.

(hi The licgsee at power reactors shall participate in the drug-i and alcohol 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 j

be established for that non-power facility.

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

555.61 Modification and revocation of licenses.

(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 oositive test for drugs, drug metabolites or alcohol in violation of the conditions and cutoff levels established by 655.53 (j) of this part, or use of alcohol within the protected area of power reactors or the controlled access area of non-power reactors, or a determination of unfitness for scheduled work due to the constmption of alcohol.

I Dated at Rockville, Maryland, this day of

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,1990.

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For the Nuclear Regulatory Comission, I

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Q sK kamuelJ.Chilk, Secretary of the Comission.

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