ML20059N452
| ML20059N452 | |
| Person / Time | |
|---|---|
| Issue date: | 03/22/1990 |
| From: | Meyer D NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Perkins K Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML19332J216 | List: |
| References | |
| FRN-55FR14288, RULE-PR-55 AD55-1-02, AD55-1-2, NUDOCS 9010150304 | |
| Download: ML20059N452 (30) | |
Text
{{#Wiki_filter:, Ao 5 S'-I-j c.7.n. e utroy m k UNITED STATES ,[ g NUCLEAR REGULATORY COMMISSION. 'D j WASHINGTON, D. C. 20555 + }AAR 2 2 iG 11EMORANDUM FOR: Kenneth Perkins, Chief - Operator Licensing Branch Office of Nuclear Reactor Regulation FROM: David L. Meyer, Chief Regulatory Publications Branch Division of Freedom of Information and Publications Services 1 Office of Administration -l l
SUBJECT:
REVIEW 0F PROPOSED RULE ON OPERATORS LICENSES The Regulatory Publications Branch (RPB) has reviewed the proposed rule that would make fitness-for-duty requirements-applicable to operator licensees. 1 'This is the first time RPB has had an opportunity to review this rule. Therefore, i we have enclosed a marked copy of the rule that presents a number of editorial I and format changes to the preamble and codified text. These changes are necessary 1 to meet the publication requirements of the Office of Federal Register. Before the proposed rule'is submitted for publication, please make sure the text is. presented in a double-spaced format. i We hav', rearranged the text in the Summary statement so that it more clearly meet', the requirements of the Office of the Federal Register [1 CFR 18.12). InaccordancewithSection1-(a)ofExecutiveOrder12662.whichimplementsthe United States-Canada' Free Trade Implementation, Act, we have inserted a 75-day comment expiration.date for this rule. We have enclosed a copy.ot the . memorandum which. explains the required 75-day comment period. We have provided the standard Regulatory) Analysis statement-that is routinely. used for. proposed rules. (See insert SA. You should ensure that the ' regulatory analysis accompanying. this rule meets the Regulatory Analysis Guidelines-in HUREG/BR-0058, Rev. 1. The standard negative Backfit Statement has been11nserted at page'6A.. As is routine, we.have.provided the Information-and Records' Management Branch of the Office of>Information' Resources Management a copy of the rule to You should consult review;for. comp (liance with the Paperwork Reduction Act. Brenda Shelton 28132):to verify.that.the Paperwork Reduction Act statement .is appropriate for this rule. 9010150304 900921 55 14200 PDR j N
[. < a g.1 = c., K,;,: p -. o Kenneth 'Perkins - If you have'any questions-regarding our comments', please contact Michael T. Lesar on extension 2775.2'or Alzonia Shepard on. extension 27651. ~~-~~ g 0 $.l% ~ David L. Meyer, Chief Regulatory Publications Branch - Division of Freedom of Information and Publications Services Office of Administration
Enclosures:
As stated -I i i 4. l l 1 it 'll i C.
dl j'Q 'URAFTo t NUCLEAR REGULATORY COMMISSION PROPOSES TO AMEND .t REQUIREMENTS GOVERNING REACTOR OPERATOR AND SENIOR OPERATOR LICENSES i The Nuclear Regulatory Commission is proposing to amend its regulations to. require, as a condition of the individual's-license, that operators and senior operators comply with the conditions and substance cut-off levels of the Commission's' fitness-for-duty requirements. t 1 As proposed, the amendments would specifically prohibit NRC-licensed operators and senior operators from using, possessing or selling illegal drugs. They also would prohibit these licensees from performing licensed activities, while under the influence of alcohol or any prescription, over-the-counter or ' illegal-substance which could adversely affect the licensee's ability to L . perform these activities. l l As-proposed, "under the influence" of alcohol or illegal drugs would mean that the licensee-exceeded the cut-off levels.for.various' drugs.or alcohol specified in Appendix A to Part 26 of the Commission's regulations or as es. ablished by the' facility licensee. "Under the influence" of prescription or-j over-the-counter drugs would be defined as the -licensee could be mentally or' -physically impaired, as determined by a medical review officer, in a manner that would adversely affect the licensee's ability to safely and competently perform licensed duties.
o f.;.7% DRAFT 2 The proposed amendments also would make clear that the NRC license of any operator or senior operatc< could be modified, suspended or revoked for. (1)thesale,useorpossessictofillegal_ drugs,orforrefusal_toparticipate in the f acility drug and alc?hei n.:+ ' a program, or for a confirmed positive test for drugs, drug metabolites c si taol in violation of the prescribed conditions and cut-off levet prna sed in the amendments; and (2) for the use s of alcohol within the protected area of power reactors or controlled access area of non-power reactors, or on a determination that a licensee was unfit for -scheduled work due to the consumption of alcohol. The Commission also propnses to amend its Enforcement Policy (Appendix C to Part 2 of its regulations) to reflect enforcement actions for individual licensed operators who do not comply with the Commission's fitness-for-duty requirements. Written comments on the proposed amendments to Part 55 of the Connission's regulations should be received by (date). They should be addressed to the Secretary of the Connission, Nuclear Regulatory Connission, Washington, D.C. c0555, Attantion: Docketing and Service Branch.
e m %o. m,
- ... ~...
g DS9 o-OQ h Nuclear Regulato omission -44u 4ff cews, m.
- U# W O A
Operator ' Licen Agency: ' Nuclear Regulatory Comission. jy Action: Proposed [ule. [g i The Nuclear Regulatory Comission proposes to amend its hSumary: that-the conditions and cut f levels established pursuant to'-10-CFR Peri. 2 , Y,,/c itness-for-Duty Pagrams," applicable icensed operators as a R condition of their license. The proposed rule provide a basis for taking enforcement actions against license operators who use drugs or alcohol in a manner that would exceed the cutoff levels contained in the Fitness-for-Duty rule,' 40 CFPm Pari. 25) 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. On June 7,1989, the Commission issued a new regulations, Part 26, " Fitness-for-Duty Programs," requirin y licensees authorized to operate nuclear power reactor plement a Fitness-for-Duty Program that would provide reasona surance that nuclear power plant personnel are not any prescription, over-the-counter or illegal substance under the inf1 o .that in ay would adversely affect their ability to safely perform their fab ta%( The proposed rc"icib-to Part S., assure a s ia a an m tiona environment for the performance of all licen d activities 6nder that par by providing a clear understanding.to licensed operators of the severity of violating 1 . requirements governing drug and alcohol use and of the impact of substance abuse.
- %>Date[ The comment 5eriod expires [ insert datekdays from d
^ . b gister publication. Coments received af ter -this.date will be considere A i" it is practicable to do so, but assurance of consideration can be given-only for coments filed on or before that date. - Ca R Addresses: Submit written coments to: Secretary, U.S. Maclear Regulatory r Comission, Washington, DC 20555, ATTN: Docketing and Services Branch.,11555 Jdbliver comments to Docketing and Services Branch, One White Flint Nort/Aw/A and m -7/che Rjckville Pike,- Rockville, MD, between Examine coments received at: The NRC Public Document Room, 2120 L Street NW', Washington, DC. A d E T G h N6k&>FORFURTHERINFORMATIONCONTACT: Kenneth E. Perkins, Jr., Chief, Operator Licensing Branch, Office of Nuclear Reactor Regulation, U.S. Nuclear N Regulatory Comission, Washington, DC 20555,' Telephone: (301)492-1031.
l~. l l' M1 de f / d N aON /fhf/* #*M0/ 805"#4 E }<* 5 Supplementary Information: fiXKGAowD R-l' 9,eQ/he Nuclear Regulatory Commission hat issued ^itt n;"hths.to require ,I licensees authorized to construct or operate nuclear power reactors to [ q The general objective of this program g implement a fitness-for-duty program. l/ J 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 Q 4i any way adversely affects their ability to safely and competently perform their duties. A fitness-for-duty program developed under the requirements of this S rule is intended to create 'y rk Onvironment which is free of drugs and alcohol and the effects o substances. 1 The Commission is now proposing to add specific conditions to operator licenses issued under 1QAFB Part SC to make fitness-for-duty requirements directly applicable to W eh-operators. As pointed out in the supplementary g information accompanying the promulgation of 10 CFR Part 26,-{54 0 24404t the scientific evidence is concis'ive that significant decrements in cognitive and j physical 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 ssarily relate directly to a current impaired state, the presence of drugs i individual's system does strongly suggest the likelihood of past, present or future impairment affecting job activities. More specifically, the Commission stated that M, .,. {. " Individuals who are not reliable and trustworthy, under the influence of any substance, or mentally or physically impaired in any way that adversely Q s p 't 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, 1989). Because there is an underlying assumption that operators will abide by the licensee's policies and procedures, any involvement with illegal drugs, whether on site or off site, tends to show that the o)erator cannot be relied upon to obey the requirements of the law and indicates t1at the individual may not scrupulously follow rigorous procedural requirements with the integrity required in the nuclear power industry to assure public health and safety. The Comnission considers unimpaired job performance by each licensed Operator or Senior Operctor vital in assuring safe facility operation. The NRC routinely denie; 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 y i tarformance of assigned job duties. Further, under 10 CFR $55.25 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 requirenje,93b or medical f l fitness, the facility licensee is required to notify the NRC. & ch" conditions I may result in the individual operator's license being modified, suspended, A, revoked. The power reactor facility licensee is further required, under L0 CFgr 626.20(a)tohavewrittenpoliciesandproceduresthataddressfitness-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 and tilness.
e uN : g a ;;p" To be consistent with this proposed rule the Co ission expects that these policiesandprocedureswillrequirethePart55licenseetoreporttheuseofrdre I rseh-drugs for evaluation by the medical r vie officer. The use of alcohol and drugs can directly impair job performance. Other causes of impairment include use of prescription and over-the-counter medications, emotional and mental stress fatique, illness, and physical and psychological impairments. Theeffectsofalcolol,whichisadrug,arewellknownand 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 (NVREG/CR-3196, " Drug and Alcohol Abuse: The Bases 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 effects on human performance (including subtle or marginal im)airments that are difficult for a supervisor to detect) can last for several 1ours or days. The proposed amendment to 10 CFR Part 55 will establish a new condition of an operator's license which will prohibit g'*w l conduct of licensed duties while onder the influence of alcohol or any -m prescription, over-the-counter or illegal substance which would advers /d d,o affect performance of licensed duties. The proposed amendment t 55 .# J l pD' be applicable to both power and non-power reactor licensed operat -T s l rulemaking is not intended to apply the provisions of 10 CFR Part 26 to < 5 t' i r 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 alcoh i,n any manner which could adversely affect performance of licensed duties il,pubject them to enforcement action. /4/d As explained in the Comission's Enforcement 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 Comission may take enforcement action for reasons that would warrant refusal to issue a license on l 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. l The Comission proposes to amend Subpart F of 10 CFR Part 55 to establish as a condition of an operator's license a provision precluding performance of licer. sed duties while under the influence of drugs or alcohol in any manner which could adversely affect performance. The Comission further proposes to i 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 modified. In addition, positive test results and failures to participate inp /d drug and alcohol testing programs may be considered in maki isions concerning renewal of a Part 55 license. These provisions L apply to any Fitness-for-Duty program established by a facility licensee, w ether or not required by Comission regulations, incluQ' afprograms which establish cutoff levels below those se' by(Appendix Ag10 CFR Part 26g The Comission V y e m e n.r. i Lf > G F,,&* ' 'W ,u 1 w 7
l j ! i l notes, however, that it has the discretion to f orego enforcement action against a licensed operator if the facility licensee established cutoff levels that are l 50 low as to be unreasonable in terms of the uncertainties of testing. The t Comission has reserved the right to review facility licensee programs against . the performance objectives of 10 CFR Part 26, which requires reasonable 1 detection measures..The proposed rule is not intended to impose the provisions of 10 CFR Part 26 (Fitness-for-Duty) on non-)ower facility licensees, but is to make compliance with the cutoff levels and ti pQcyandproceduresregarding of legal drugs established pursuant t Part 26 a license condition for th gsp[t 55 licensees. Further, the proposed ula is not intended to apply al Pareement sanctions against operators or senior operators for their proper en use of legal over-the-counter or prescription drugs, bu' 'a require the reporting of such drug use, or medical conditions reo ~g the use of e drugs, to the facility licensee in order for a medic 6..eview officer to determiyet operator'sjinegs,fpr;dgy,.g 4/,,,/c ,,,,/ "hio e en W M e 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 /o C r4 Part 55 licensee's obligations, the Commission 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: In cases irwolving 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 i 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., l exceeds the cutoff levels of 10 CFR Part 26 or the facility licensee's 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 l 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 l 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 w1o is involved in the scle, use, or possession of an illegal drug may be subject to license suspension, revocation, or denial. 1 .To assist in determining t e severity levels of potential violations, h 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 III 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 f. prepared for this proposed rM e. f _m
p[3Mg? 4 ' 6 pp.s h, gg)*' k/ sh/wn& j P ly1 Uk I Paperwork Reduction Rev4ew-- j / This proposed rule contains no information collection requirements and, l h' k# therefore, is not subject to the requirements of the Paperwork Reduction Act of 1980(44U.S.C.3501etseq.). P[GULATORY,A/ALYSIS # M i gi fh-kky. ~ I Re regulations in 10 CFR Part 55 establish procedures"sn'd'crftefii fo'rN J Lhe issDattce of licenses to Operators and Senior Operators of utilization /acilitiesN4 censed pursuant to the Atomic Energy-Act of 1954, as amended, or I , /Section 202 of'%e Energy Reorganization Act of 1974, as amended, and 10 CFR { i Part 50. These e hablished procedures provide for the terms and conditions .j, i { upon which the Commis' tion will issue, modify, maintain, and renew Operator and i j Senior Operator licenses.N l N SubpartFofPart55,undebl55.53("ConditionsofLicenses"),setsforth { ' 4( ) [f the requirements and conditions for'the maintenance of O i th Operator licenses. \\ { i Amending Subpart F to prohibit performance of licensed duties while under -[ the influence of drugs or alcohol in a manner which could adversly affect safe { and competent performance of licensed duties will provide notice to licensed f individuals of the gravity of violating these requirements and will provide i f c.ssurance 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 b will be taken and the penalty for violating the conditions or cutoff levels contained in 10 CFR Part 26. / l
- 4. N " ' " a r n~<, w e -
/GULATORYf/EX1BILITYC/RTIFICATION R The oposed rule 1 not have a significant economic impact upon a J substanti number of small entities. Many operator license applicants or operator licensees fall within the definition of small businesses found in i Section 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(50FR50241). 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), theNRChwebfcertifiesthatthisrule,ifpromulgated,willnothavea significant economic impact upon a substantial number of small entities. ) i 1
Regulatory Analysis I This Commission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The draf t analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW (Lower Level), Washington, DC. Single copies of the draft analysis may be obtained from (insert name, address, and telephone number of contact person). The Commission requests public commer.L on the draf t regulatory analysis. Comments d'n the dr'af t analysis.may be submitted to the NRC as indicated under s _, s. the ADDRESSES heading. '[ N IO\\. 1 % f < h. . w.. g sa,...< g -.i }e c ~f.A a,, 5..a 2 c o r. 1.a, -a,.. q., ... n, ~,.a u u,..-, 1 q h ho,sf N ih. s,t ita, t,., e.mnl.,a,( (,. +[,v,, -,., '., Lu 9 A rs /Viory for /be 'fros ol-x yle v in -s en tp q M, an, pn ~t , a n p,g j,ld( {e. e~ g e*% 4 ,G ts...+,& nai. f r.s.-.,~- $ i.an.,9*J ,)nLjf g n,A ifly r, of _, whr se,4p,o)/,,y (nepec/jpgg /he} st egy/fe,p Mf Os, f > >4 m. sww -y y,-
- g ff, g,f,jjg f
%;Mf Mg d4 g ] f M,' 6. p F
I l l l h BACKFIT ANALYSIS Mu~6 M& O*^"# This proposed rule does modify or add t t tures. the desigh r val or manufacturing p components, or design of a f 6cility; 7; or the procedures or organization p1 .. license for a nuclear reactor y lit required to design, conitruct, or operate a. facility. Accordingly, no backfit c'TD CFR 50.109 is required for this proposed rule. { g analysis pursuan I _ g,,,1/"Nist of Subjecks' in 10 CFR Part 55 Manpower train 131 programs, Nuclear power plants and reactors, han:My g-Reportingandrecorgf,eepingrequirements wa a. t For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Epergy 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 D 1. The authority citation for Part 55 is revised to read as follows: Sec. 107, 161, 182, 68 Stat. 939, 948 953, as-i AUTHORITY: amended, sec. 234, if3 Stat. 444, as amended (42 U.S.C. 2137, 2201, 2232,(2282); secs. 201, as amended, 202, 88 Stat.1242, as amended 1244 42U.S.C.5841,S842). 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 68 Stat. as amended (42U.S.C.2273)posesofsec.223;il55.3,55.21,l55.53(j).55.4 and 55.53 are issued under sec. 1611, 68 Stat. 949, as amende (42U.S.C.2201(1)); and il 55.9, 55.23, 55.25, and 55.53(f) are issued under sec. 1610, 68 Stat.950,asamended(42U.S.C.2201(o)). paragraphs (j) graph (j)isredesignatedasparagraph(1)andnew-In $55.53, para 2. and (k) are added to read as follows: t. j55.5 Conditions of licenses. ) $0 N d s,N s s s s s --
- '/
The licensee d n"ot consume or ingest alcohol within the f!' (j) protected area of power reactors, or +he controlled access arenha 67 0 of non-power reactors. The licensee he44' not use, posTess, or s k sell any illegal drugs. The licensee % not aerform activitie,s S O.' authorized by a license issued under this part w111e under thel #"'l influence of alcohol or any prescription, over-the-counter or l 1 l
I Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does n apply to this proposed rule, and therefore, that a backfit analysis isj required for this proposed rule, because these amendments do not )(1). any provisions which would impose backfits as defined in 10 CFR i i --marn,ano _ i f 'N ' " .= g 4 l g.... g l i i I l l l l L 7 i t l l 1 t i I 1 l-l 1 i l l 5 i l 4 m
h4 ;....,, 7 Jon9 nap h illegalsubstancewhichcouldadvedlyaffecthisorher ability to safely and competenti erform his or ner licensed duties. For the purpose of this d acciivri, with respect to alcohol and illegal drugs, the term "under the influence" means the licensee exceeded the lower of
- ce levels for drugs or c1cohol contained in(Appendix dTP" art 26, of this chapter, or as estai>1hbad by the facility licensee. Wihrespectto prescription and over-the-counter drugs, the term under the influence" means the licensee could be mentally or physically impaired, as determined by a medi review officer, in such a manner as to adversely affect his her ability to safely rind competently perform licensed duties.
(k) The licensee at power reactors shall participate in the drug 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 be established for that non-power facility. i W t P t y-3. In $55.61, a new paragraph (b)(5) i' added to read as follows: [55.61 Modification and revocation of licicses. - Y (5)Forthe 1e, use or ossession ille al drugs, or refusal to participate in the facility drug and alcoho testing program or a confirmed positive test for drugs, drug metabolites or alcohol in violation of the conditions and cutoff levels established by m ;;vn " .g55.53(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. e* /f/4 L . Dated at Rockville, Maryland, this day of - 7 s For the Nuclear Regulatory Commission, y i L l Samuel J. Chilk# Secretary of the Commission.
C l ef3 - ( & W s Se y &C 5 Res.Po6. W J. 3 dopg.32fr-io s VJ'c(p. {yf 40 ~of
- i
~ s g// d M ' ,k Nuclear Regulat r Comission *' #y fe Oper tor ' Lice g y, e4 3go - Ah 6 { l l [VAgency: 0 Nuclear Regulatory Comission. j Action: Proposed Rule. Sumary: The Nuclear Regulatory Comission proposes to amend its regulations ..x +1,e A., .o aoa*s i " W M that the corditions and cutoff levels established pursuant to Ma0M 4 eut:$6, w i " Fitness-for-Duty Programs," edip0be applicable to licensed operators as a g The proposed rule A.oi.( provide a basis w condition of their license. 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-ft ruty rule, E CYrt Iwho are under the influence of any pres s iption or over-the-counter drug which could adversely affect his or her ability t, safely and competently perform licensed duties, or who sell, use, or possess illegal drugs. l l l On June 7,1989, the Comission $t 1 a new part to regulations, Part 26 " Fitness-for-Du Programs," re ring facility 11 nsees author d to operate n e'ar power re rs to implement a itness-for-D Program t x, would vide reason e assurance that clear power p nt person are not U / un r the influ ce of any prescri on, over-the-nter or i egal substance tiat iny way would adverse) affect their ability to safely perform their l job duties. t yvL t weeld The proposed ::hh? t;; Te. i. 55 wSM assure a safe operational environment for the performance of all licensed activities C - < Y ;:-t by providing a i j
i o. s l citer understanding to licensed operators of the severity of violating j requirements governing drug and alcohol use and of the impact of substance f i abuse. l / n S" pi 'dee4 -i Dater / Thecommentperiodexpires[S::rt4:t: 49 days from date of Fede al ecister publicatio Coments received af ter this date will be considered if it is practicable to do so, but assurance of consideration can be given only for coments filed on or before that date. p[! , Addresses: Submit written coments to: Secretary, U.S. Nuclear Regulatory Comission, Washingtsa, DC 20555, ATTN: Docketing and Services Branch, d / liver coments to Docketing and Services Branch One White Flint North,11555 7:4r 9 er Rockville pike, Roci:ville, MD, between 645 a[/and h00 p~liIi/ f 4ral W*M 5 + l 3 / N xamine coments received at: The NRC Public Document Room, 2120 L Street NW, E Washington, DC. 2 o rr C. t FOR FURTHER INFORMATION CONTACT: Kenneth E. Perkins, Jr., Chief, Operator Licensing Branch. Office of Nuclear Reactor Regulation, U.S. Nuclear y l Regulatory Comission, Washington, DC 20555 Telephone: (301) 492-1031. i Supplementary Information: 0 hkiW e k Ib H ( ON [e Nuclear Regulatory Comission has issuedbt: 7:; M n to require 0 A licensees authorized to construct or operate nuclear power reactors to } v implement a fitness-for-duty program. The general objective of this program j 7 k o \\
=.. c. is to provide reasonable assurance that nuclear power plant personnel will pt.rform 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 intended to create a work environment which is free of drugs and +(nse alcohol and the effects of esseh substances. The Commission is now proposing to add specific conditions to operator licenses issued under 10 CFR Part 55 to make fitness-for-duty requirements l -%a. directly applicable to seseh er.ators. As pointed out in the supplementary information accompanying cne promulgation of 10 CFR Part 26, 6 " aNthe 1 scientific evidence is conclusive that significant decrements in cognitive and physical 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 eddictive and impairing nature of certain drugs, while recognizing that the presence of drug metabolites does not necessarily relate directly to a currentimpairedstate,thepresenceofdrugsihindividual'ssystemdoes k strongly suggest the like11hool of past, present, or future impainnent affecting job _ activities. More specifically, the Comission stated that " Individuals who are not reliable and trustworthy, under the influence of any substance, or mentally or physically impaired in any way that adversely $ffects x i [ their ability to safely and co ipetently perform their duties, shall not be licensed a? permitted to perfonn responsible health and, safety functions." (See 54FR24468, June 7,1989). Because there is an underlying assumption that operators will abide by the licensee's policies and procedures, any involvement
i P with illegal drugs, whether on site or off site, tends to show that the operator cannot be relied upon to obey the requirements of the law and indicates that the individual may not scrupulously follow rigorous procedural requirements with the I integrity required in the nuclear power industry to assure public health and safety. The Commission considers unimpaired job performance by each licensed Operator or Senior Operator vital in assuring safe facility operation. The NRC routinely denies Part 55 license applications or conditions operator and senior operator licenses if the applicant or licensee's medical condition or general health does not meet the minimum standards required for the safe performance of assigned job duties. Further, under 10 CFR 655.25 if an I operator develops, during the term of his or her license, a physical or mental I condition that causes the operator to fail to meet the requirements for medical %ese A fitness, the facility licensee is required to notify the NRC. Such conditions may result in the individual operator's license being modified, suspended, or Thepowerreactorfacilitylicenseeisfurtherrequired,underEE50$h revoked. $26.20(a) to have written policies and procedures that address fitness-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 and illness. i To be consistent with this proposed rule, the Commission expects that these policies and procedures will require the Part 55 licensee to report the use of tLene noch drugs for evaluation by the medical review officer. t t t 4 g
e The use of alcohol and drugs can directly impair job performance. Other causes of impairment include use of prescription and over-the-counter medicaticns, l emotional and mental stress, fatigue, illness, and physical and psychological impairments. The effects of alcohol, which is a drug, are well known and 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 I (NUREG/CR-3196,"DrugandAlcoholAbuse: The Bases for Employee Assistance Programs in the Nuclear Industry," available from the National Technical InformationService). The greatest impairment occurs ehortly after use or abuse, and the negative short-term effects on humn performance (including t subtle or marginal impairments that are difficult for a supervisor to detect) can last for several hours or days. The proposed ateendment to 10 CFR Part 55 % I). V wiW establish a new condition of an operator's license which will prohibit conduct of licensed duties while under the influence of alcohol or any l prescription, over-the-counter or illegal substence which would adversely wo(d [ sffect performance of licensed duties. The proposed amendment (-- E--T 55 utN g i 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 L operators (power and non-power) through a condition of their license that use l= i: of drugs or alcohol in any manner which could adversely affect performance of 1 word J l licensed duties subject them to enforcement action. ~
i i j o As explained in the Comission's Enforcement Policy (see 53 FR 40027, f October 13,1988), the Comission 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 Comission may take enforcement action for reasons that would warrant refusal to issue a license on an original application. Accordingly, enforcement action may be taken regarding i I 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, f i The Comission proposes to amend Subpart F of-10 CFR Pari. 65 to establish as a condition of an operator's license a provision precluding performance of l licensed duties while under the influence of drugs or alcohol in any manner 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 modified. In addition, positive test results and failures to participate in drug and alcohol testing programs may be considered in making decisions wed concerning renewal of a Part 55 license. These provisions M apply to any Fitness-for-Duty program established by a facility licensee, whether or not required by Comission regulations,M zu, n,% programs which establish including a ertt M w := n. cutoff levels below those set bye % : "'- A, ;; ;T2 7 ct 5. The 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 i -m.
..u. i I 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 makecompliancewiththecutofflevelsandtheylicyandproceduresregarding g the use of legal drugs established pursuant to*Part 26 a license condition for 10 c F C all^Part 55 licensees. Further, the proposed rule is not intended to apply ^ enforcement sanctions against operators or senior operators for their proper use of legal over-the-counter or prescription drugs, but to require the reporting of such drug use, or medical conditions requiring the use of drugs, to the facility licensee in order ior a medical review officer to determine the operator's fitness-for-duty. g m prepos,.C vote a aM"A "S d #""' d /\\ -- " " "- 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 to CFf w Part 55 licensee's obligations, the Comission intends to modify the NRC g Enforcement Policy in conjunction with the final rulemaking. It is the Comission's intention to modify the Enforcement Policy as follows: 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 l 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., exceeds the cutoff levels of 10 CFR Part 26 or the facility licensee's
} 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 ~1icense, 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 modified 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. Environmental Impact: Categorical Exclusion The NRC has determined that this proposed rule is the type of action describedincategoricalexclusion10CFR51.22(c)(1). Therefore,'neither an environmental impet statement nor an environmental assessment has been prepared for this propostd rule.
i [ i A e e S r s e e e ~ e-Paperwork ReductioMAelWow This proposed rule contains no infomation collection requirements and, therefore, is not subject to the requirements of the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.), us e awNd c 6 s / RIGULATORYlARYSi5}
- '# # ' " 5 '-
v v i i 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 Reorgaaization 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. L SubpartFofPart55,under555.53(*ConditionsofLicenses"),setsforth i the requirements and conditions for the maintenance of Operator and Senior Operator licenses, 1 Amending Subpart F to prohibit performance of licensed duties while under ceofdruysor\\1cohol na anner w ch could a ersly affe safe the in and ompete per ormance of 11 ensed du es ill prov de notice to censed I. I dividuals of he gravity o-olating t e requir nt and wi pr Jde [assurancethatn ee fac lities a b ing opera e safely.
- r. - > r ~ c " ^ < w " ' """'
1 ,u,,,,,,,.c <se,- 9 sa,, e s a....,.,,
- c.,. ~.,... m., ~,,
,,,,,.>, o - ~ ~ o - 3,.,,,. ,.o r r u, r....... <,, o,, n.., _. o r,, s..,3,~,<,, a <.. + @Q J M -o 4 + Mc, t ks.t o wm.1le costs & Q e6 1A> O~*% e Q ru ^^ '% S O co A w C h 'cLaC M.i t % e a s y ks, W y*- f.r zkr no.s vH nw,o u a < n p 4 4 -tin u.tc Pu M beco~r~* R*** Y ? $ U X'k W ' W;4%%jkCRkWT %$UNY'
i., Amendi Subpart G to provide xplicit add ional not 'ce to 1' cense operators ' f the term /and co\\ nd t ons under wh ch a li e may e rey ed, suspended or mod f d will des ribe c nces in ich enf r me action will taken and th pWit for violating the conditions or cutoff levels contained in 10 FR part 26. y 44/5 REhULATORYFEX1BILITYCNTIFICATION # x The proposed rule will not have a significant economic impact upon a substantial number of small entities. Many operator license applicants or operator licensees fall within the definition of small businesses found in Section 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(50FR50241). 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), the NRC M certifies that this rule, if promulgated, will not have a x significant economic impact upon a substantial number of small entities.
.t l M eie l BA'CrrITA[ALYSIS [ + + This proposed rule does n modify or add o systems, structures, f f corponents,pf design of a acility; the sign approva Por manufacturing / / t license fo/r a nuclear eactor faci y; or the pr dures or or nization i / / Ac disgly, no backfit requirp8 to des p construct, roperateaficility. ana is pursyant to 10 CFR 50.109(c) is required for his proposed rule. I List of Subjects in 10 CFR Part 55 t Gndud pennin ^ Manpower training programs, Nuclear power plants and reactors, f Reportingandrecor[keepingrequirements i C cu wJ For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amenderi, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following ? l amendments to 10 CFR Part 55. [ g i 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, 948 953, 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, 1244 (42 U.S.C. 5841, 5842). ,,m. __,___,.m_ .m
?. O Sections 55.41, 55.43, 55.45 and 55.59 also issued under sec. 306, Pub.L.97-425,96 Stat.2262(42U.S.C.10226). Section 55.61 also issued under secs. 186,187, 68 Stat. 955 (42 U.S.C. 2236, i 2237). ~ i For the purposes of sec. 223, 68 Stat. 9EB, as amended (42 U.S.C. 2273); il 55.3, 55.21, 5.49 and 55.53 are issued under sec. 1611, 68 Stat. 949, as amended (42 U.S.C. 2201(1)); andil55.9,55.23,55.25,and55.53(f)areissuedundersec.1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)). 2. In655.53, paragraph (j)isredesignatedasparagraph(1)andnew paragraphs (j)and(k)areaddedtoreadasfollows: ---? j 55.53 % Conditions of licenses. - 3 I _.m (j) The licensee shall not consume or ingest alcohol within the protected area of power reactors, or the controlled access area l_ of non-power reactors. The licensee'shall not use, possess,,or sell any illegal drugs. The licensee shall not perform activities authorized by a license issued under this part while under the influence of alcohol or any prescription, over-the-counter or .m
'O illegal substance which could adversely affect his or her ability to safely and corrpetently perform his or her licensed hemrdh M duties. For the purpose of this a M with respect to alcohol and illegal drugs, the term "under the influence" means the licensee exceeded the lower of the cutoff levels for drugs n ut Fe+s% Ac 4 % or alcohol contained ind?; t '~ d, A r,T 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 medicc1 review officer, in such a or manner as to adversely affect his Mer ability to safely and competently perform licensed duties. i l l (k) The licensee at power reactors shall participate in the drug and alcohol testing programs established pursuant to 10 CFR Part 26. The licensee at non-power reactors shall I participate in any drug and alcohol testing program that may be established for that non-power facility, 4 4 + E' A u l l 3. In$55.61,anewparagraph(b)(5)isaddedtoreadasfollows: -) _ lh 55.61 - y Modification and revocation of licenses. 3 l M 4 i @) 4 5}Forthesale,useorpossessionofillegaldrugs,orrefusal to participate in the facility drug and alcohol testing program, or a confirmed positive test for drugs, drug metabolites or alcohol in
1 i l A violation of the conditions and cutoff levels established by n { 55.53 (,1) of this part, or use of alcohol within the protected area of power reactors or the controlled access area of non-power reactors, i or a determination of unfitness for scheduled work due to the f consumption of alcohol, i L-T. IM Dated at Rockville, Maryland, this . day of l 9 'l 0, ef X, [ _. l For the Nuclear Regulatory Comission, i ? l r I Samuel J. Chilk) l' Secretary of the Comission, l i l 1' l l 1 t l
(qA. A *y L 1 %wesp r.m v
- C
~ 3-3 6 y-A05 R - Nl% ' 77 '~,Q' L PNec
- a p
N ff, ww, yh(rqhy v'A' ?o N TJack' Roe: 9/14/89 ) i; ", Rei Reactor Operator Fitness'for Duty J b4 This papersinvolves-a, number of important policy matters with' respect t'o:those aspects which go beyond imposing the Pt 26 cutoff levelslas7 conditions of#Part SS operator licenses;.These 1 nee'd to be specifically identified.and justified in the Commission paper. As the proposal now-stands the Commission-( paper.needs something along'the following lines: h$ Beyond making tha Part 28 cutoff liniiss < enforceable'- conlitions of P:rt 55 operator. licenses.,the: proposed rule-kh. contain's a number of additionalcprovisions directed toward . assuring 1that cperator performance is'not adversely affected-by~ drugs,Lalcohol or mental or physical impairment. W, m,, First; the proposed rule prohibits operator use of legal &T (over-the counter or4rescription). drugs,-if the operatort h "" -"could be= mentally?or physically,impairedwin such aLaanner: i, L. so ae to adversely affect'his or' her. ability,to safely'and;
- s
- .y*.
- competently perf ormL11 censed' dtities'. "IThis standard will' f' apply without regardito th. whether; theLoperator's.use of f legal drugs may~ conform to thecPart 50 facilityclicenseets ~ ' fitriess for duty program; pertainingsto abuse of' legal ; drugs. m .4 L %" ' It is important.for NRCsto establish itsJ M.ndard n sta 2[ ~ regarding the use ofilegal drugs because. (r:= # :;1e need +a *ill 4n +h ib +4f4 W id.):/... 4 J. he' appropriate ~ m
- standard for NRC to-impose directly'on operators is "could be' mental.ly or physically impaired in'suchia manner asito'.
V adversely affect his or.her. ability;to' safely and fE competently perform;licensedW since-it assures..,..-(youineed W G,t to' explain why "could" affect performance is the. appropriate. h&' standard to impose on-operators)c.......>..... R:R, m -n 1 L 1 .5 :' '_ j. 4 s Second the proposed rule similarly prohibits operators from e<* performing licensed _daties when " mentally or physically MOh handicapped fromLany.cause which adversely affects his or, 4 lil;, her' ability to safely and competently perform;1icensed 4 . duties;" The kinds of conditions encompassed by'this' i'; B %y standard include emotional and mental stress, fatigue,..
- We w illness and physical and psychological' impairments [should; f
we include allergies-again as weLdid in the:first draft?). .m This requirement is in addition.to and not necessarily 0 4l ~ .related toLthe Part 50 licensee's obligation to inform.NRCJ ~ hen ~an licensed operator-develops a physical or mental 1 q W w condition that causes the operator'to fall the medical i% qualification requirements of Part 55. In addition, this ~ RF standard will apply without regard to the Part 50 facility o ,y
- licensee's fitness-for duty program pertaining to mental
'i stress, fatigue, illness, etc. A requirement over and above e Q: l _l-;i. %~^.. J%L hk. +3<&v,& '_ q am 1
\\ the present Part 55 requirements and Part 28 requirements relating to mental and physical condition is important because Third, the proposed rule explicitly prohibits licensed operators from engaging in the sale, possession or use of illegal substance without regard to whether such sale is on or off site. Although Part 26 provides a specific sanction for onsite sale, possession and use, the staff believes that the specific prohibition on licensed operators against the sale, possession, or use of illegal drugs on site or offsite is consistent with the policy requirements of Part 26.( .and/or whatever else you want to add.....). Fourth, the proposed rule prohibits the use of alcohol within the protected area and prohibits licensed operators from engaging in a licensed activities if the operator exceeds the cutoff level established under Part 26. These are consistent with Part 26. Iloweve r, as the staff makes clear in.the Supplementary Information, the staff proposes to modify the Enforcement Policy to impose sanctions for violation of the rule with respect to alcohol uso equivalent to those imposed for use of illegal drugs. Part 26 explicitly imposes sanctions for use.of illegal drugs. It does not explicitly impose sanctions for alcohol abuse, leaving sanctions to the licensee's fitness for duty progrhm, but requiring sanctions sufficient to deter abuse. The staff believes it appropriate for NRC to specify sanctions for exceedinc the alcohol cutoff levels and that such sanctions should be the same as those for exceeding illegal drug cutoff levels, because......... To-my mind, most of these issues become of lesser significance if they are tied into existing requirements such as Pt 26 and other parts of Pt 55 - e.g. use the licensee's Pt 26 standards or the Part 55 medical procram as the source of judgement about-legal ' drug abuse or montal and physical impairment. The thing that makes these things of significanco is that you appear to be creating a whole new set of standards. ) fy w' buinto ec: STreby
., 7 AOss-t > (Lf m rt. /c- /AJ %;s ana, L*
- ',,..., % 'o, I.
f UNITED ST ATE S /. m
- o.
? 'n NUCLE AR REGULATORY COMMISSION y,. i ) usm~ctow.o e mss ~ %,.. // pi j /hte p p(p (n 9 ~ f) hg@ (/g L \\f (F NA i 10 1 ut It li.. : ann t.1 12/ I E./ E4 , tit.'i.i N ~i t in r Dut li: :.. /.. i., i, i i.
- tii
.r u bs'. o l bi t. 4 U' Nb l* b L VD b** l l. t 1.- .+t M/ ti k/ i.e. r r, 9/ g g,fP en im. E i. ti n!. / (f .w s i c u., i ui., o,1 .. >u / DE St' 1 ROUTINbt P F..I O.i t ' Ft it 3 L i t. i n 1 L ht f.i l UN FiINIds Fuh I'U1 i MUkL E i < bN J L ? F.I. a . OF Nb C. L 1 thLi. 4 e i Hr b iHsN Ni t-i. i .4t-tUWr.F PL 4 J l b)LLE!IJt t L ii fini ES Gb ] Mi .4 11esSbukth a.h 3 ONI-i, I<.. Cuu i ev.. FMAS 61 t.t J L t i J L /McNENNA Flocse review the due date immed14telvt 14 the due date does not allow adequate time to respond to this ticlet, you niay request e revi sed due dat e. The request must have prit.r appr ove j i r em t he +ppropr i ete Ass.oc l eit e D1 rect or or NRh D7put y. Di rect or. And must include a val i d,)us.t i i s c ati on. Contact NRR met } rconi w1 th the new due date (Doris Mossburg. x-20072). Please do not c ar r y concurrenc e pect: ages, to Dir ett or s - of f i ce wathout. (3 rat going theough the NRR mai1 room, gg gn,s-=:~,,_ g 4 & ^ % & ogt e-A - D., T ]... i}}