ML20058G953
| ML20058G953 | |
| Person / Time | |
|---|---|
| Issue date: | 11/30/1993 |
| From: | Cranford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| To: | |
| References | |
| OMB-3150-0146, OMB-3150-146, NUDOCS 9312100195 | |
| Download: ML20058G953 (35) | |
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Reac tnstructions before completmg torrt Do not use the same SF 83 Send three copies of tnis form. the material to be reviewec, and for to request both an Executive Order 12291 review and approvat uncer paperworx-three cop.es of the supporting statement, to.
the Paperwork Reduction Act.
Arswer all cuestions in Part I. !f this request is for revre* uncer E.0, Othee of information and Regu!atory Affasts 12291, compiete Part il and s:gn the regulatory certificat:on if this Othee of Management and Bucget recuest ts for approval u cer the Papemern Recuct:en Act anc i CFR At#entior Doc >et Ltrary Roorn 3201 n
1320. sep Part 11, corraiete Part ill and s gn tne paperworx cett. cat:cn Wasning*on. DC 20503 PART L-Complete This Part for All Requests.
- 1. Ocpartmert agency anc 6 reau o*t ce oog ret rg re.est 2.Agencycoce t
l U.S. Nuclear Regulatory Commission
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- 3. N me of person wno can best a-s*er c.est ors regarc.ngin s teceest Te.epnare umper Eugene PtPeek
( 3 01 : 504-3210
- 4. Titie of information conection or ruemamrg 10 CFR Part 26:
Fitness for Duty Programs saegni autnorwor mwmaton mecw or r. ce uraec aares cxe Fac.a* or aece.e orcer>
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- 6. Affecec autoc (checa aII fnaf 200'y1 5 C Feceraf agent;es or empiovees 1 U inoma,ais or householes 3 C Farrrs 6 [ Non-protat inst:tutions 2 O State or local gover~ rents 4 i Busmesses or etner +ar. pert 7 C Small busmesses or orpneors
,9-PARTll.-Complete This Part Only if the Request is for OMB Review Under Executive Order 12291
- 7. Reguistion ident:f'er Nu-t;er (P:N)
_ _ _ _ _. or. Nor e ass.gnec U
- 8. Type of suomissson tcrece ore m eacr categoM Type of revsen recuested thsnification
$tsge 01 development 1 [ standare I C Maior i U P*oposec or c*a*t 2 C Pendmg 2 U Nonmaior 2 C Ena'or Wenm fmaL *:ta pr cr proposai 3 C Errergency 3 C Finat or mienn fanat etrout poor proposa.
4 C statutory or judic:ai ceachne
- 9. CFR section affected CFR
- 10. Does t'us regu!ation contain repor mg or recorc*eesmg recuremerts tnat recure CMS aporovai under the Paperworm Reduction Act anc 5 CFR 1320?
[ yes
[ No
- 11. If a mafor rme. :s there a reg aatory impact ana'ys+5 attacnec) 1 C yes 2 [ No It"No." cic OMB.ame the araivses?
3 U ves 4 C No C rtification for Regulatory Submissions in suomeng this reauest for CMB *erew. **e autner.zec ega;atc y cortact anc tre cmcam c+c:a; cecy tnat t e ret:u're erts cf E O 12251 and arv a:pocat e pobcy cirectwes rave been cornance et-Stgnature of prog am crticiai lDate t () n n rs.s
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P ev cus ec.tior s ornoiete o gj stancard f orp 83. -
-L NsN 7540c,M44034 F er :+ :. YE 5 CFR 132 - cE:.C 4 9312100195 931130 PDR DRG EUSOMB PDR v
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f Q_c PART lli.-Cotnplete This P rt Only if th) Request is for Apprxl cf a Collecti:n of information Under the Paperwork ReducUon Act rnd 5 CFR 1320.
- 12. Absaset-oncribe neces. usa and aft cteo pubhc in so wores or ies: " Nuclear 5afety, Fitness-For-Duty Drug Testing a The final rule will permit nuclear power plant licensees and licensees who are authorized to possess, use, or transport formula cuantities of strategic special nuclear material (SSNM) to reduce the random drug testing rate from 100% to 50% for licenseemmployees, contractor employees, and vendor employees.
- 14. Type of mformaton conecton (check on'y one)
Informatoon coliections not contatned in rules 1 C Regular 5 bmission 2 U Emergency suemission (cer focar,on aracnec)
Informstron collections contained in rules 3 U fxstang regua*cn (no charge proposed) 6 Fmat or interim tene ethout pnor NPRM
- 7. Enter caw of expected or act at f ecerai 4 [ Notice of proposed ruiomaung(NPRM)
A Regular s ormss,an Reg ster pub: cation at th s singe of rsemakmg
- 5 C fmal NPRM was previous!y pubashed B C Emergency suem:ssion (ce t+caron ar* ached)
(month, asy. fear)
- 15. Type of revnew requested (chec* only one) 1 New cohection 4 C Re'nstate nent of a previously approved cohect:on for which approval has expM 2 @ Revison of a currently approved collection 3 C Extensen of the expiration cate of a currentty approved cohecton s U Distmg cohecton in use without an oMB control number wrthout any chen2e m the substance or m the metnoc of conecten
- 16. Agency report form number (s)(#nc!uce stancarc/ optional form numDeTs))
- 22. Purpose of mtorrnation cohection (eneck as many as apply) 1 C Apobcaten for benefits
- ) / A 2 U Prog am evaiuston
- 17. Annual reporting or ceosure buteen
- nu@er rounded 3 U Generai purpose satistits N
4 3 Regulatory of comphance 1 Number of respondents.
BOO
- 5 C Prog am plannmg or management 2 Number of responses per responcent, 3 Total annual responses (hne 1 times hne 2)
'"*, 7 e 0 6 c.; Rese,ren es n
i 4 Hours per response
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7 C Audit s tat,i hours ame 3 nrnes sm, o 7,442
- 18. Annual recorcneep!ng Duroen
- 23. f recuency of recorckeeping or reportmg (checa ah r%st appiy>
7b 13 Recorckeeping 1 Number of recorckeepers 993 l
RepoWns 2 Annual hours per recorckeeper 3 Totai recorame. ping hours ome J times hne 2) i 58.023 2 3 on occasion 4 Recordkeepmg re ention penoo 3, 5 and durati on of years!
3 0 weeu,
- 19. Total annual Durcen Licelse j
, g ugnty,,
00*000 l
5 0 Quarteny 1 Requested (hne 17-5 plus kne 1B 3) -
01,932 6 3 semrannuaHy 2 in current oMB mventory
- Ib*4b7 7 C AnnuaHy 3 Dit*e ence (hne 1 ress one 2)
Explanation of dttterence B U B.ennaaoy
- Ib*4b7 9 0 o*yergescru) a Prog am change 5 f dvstment l 24. Responcents' ochgaton to compey(check the strongest ochg
- 20. Curr:nt (most recent) oM B control number or comment number 3150-0146 3 o yo,una.,
- 21. Recuestec expiraton care 2 C Recui ed to obtain or retain a benefit 4/30/96 3 2 u,neatory
- 25. A r the responcents onman'y ecucational agencies or inst:tutons or is the pnmary purpose of the cocectron reistec to Feoeral educaten peccams? O Yes O No
- 26. Does the agency use sampimg to seiect respondents or coes the agency recommend or presende the use of sampur:g or statistical anatysis
.-L Yes C No Dv responcents?
2 7. Rggulatory authority for the in*ormation conecton lu PART 26 CFR
. er ra
. o,. otner (spec,*y) y E perwork Certr$catm in sub nctmg this recuest for oMB app
- oval. the agency head. the semor c" scia: or an author 2ec representat've. cemhes that tne recuirements cf 5 CFR 1320. the Prwccy Act. stat:stical stancarcs or cireet'ves. and any other apphcab*e mtormation poncy cirectives nave been compned with st2 nature of program ot+1cial Date
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5, gnat ency neac_tye sg or o?c t or an acoreec represer tative osie Ge/aQEdr
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c SUPPORTING STATEMENT FOR FINAL RULE.
"10 CFR PART 26: MODIFICATION TO FITNESS-FOR-DUTY PROGRAM RE0VIREMENTS" l
I (OMB Clearance No. 3150-0146) l DESCRIPTION OF THE INFORMATION COLLECTION The Nuclear Regulatory Commission is amending 10 CFR Part 26, " Fitness-for-Duty Programs," to permit nuclear power plant licensees and licensees who are authorized to possess, use, or transport formula quantities of strategic i
special nuclear material (SSNM) to reduce the random testing rate for drugs i
and alcohol to 50 percent.
j The reduction in the number of random tests will reduce the recordkeeping and interi;al reporting requirements associated with the collection and testing of urine specimens contained in Appendix A to 10 CFR Part 26.
These requirements include the reporting of test results by the certified laboratory.
The proposed rule which OMB approved on June 2,1993, would permit licensees to reduce the random drug testing rate of licensed employees for drugs and alcohol to 50 percent, but to maintain 100 percent drug testing rate for contractor ahd vendor employees.
The final rule will permit licensees to also i
reduce the random testing rate of their contractor and vendor employees for drugs and alcohol to 50 percent.
A.
JUSTIFICATION 1.
Need for the Collection of Information i
Licensees must create specified records, such as chain-of-custody forms, to properly manage the testing program, assure accurate and reliable results, protect the rights of those being tested, and have evidence of program violations that require the imposition of sanctions.
2.
Acency Use of Information Other than small chances in the numbers which constitute the data provided the NRC under 10 CFR 26.71(d) and the number of reports made under 10 CFR 26.73, there is no change in information provided to the NRC, which is used to determine if there are problems requiring timely action by the NRC staff, to monitor compliance, and to perform empirical evaluations of this evolving discipline in support of any future rulemaking consideration.
3.
Reduction of Burden Throuch Information Technolooy There are no legal obstacles to reducing the burden associated with this information collection.
Licensees are encouraged to use modern
)
information technologies to collect, analyze, and store the information required under the provisions of 10 CFR Part 26.
4.
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4.
Duolication With Other Collection of Information The collection of information required by 10 CFR Part 26 does not duplicate any other requirements for collection of information.
5.
Effort To Use Similar Information There is no similar information available to the NRC.
6.
Effort To Reduce Small Business Burden The information collection required does not affect any small business.
7.
Consecuences of Less Frecuent Collection The amendment to 10 CFR Part 26 affects only the number of random tests administered to licensee, contractor, and vendor employees.
it does not affect the types of records and internal reports that must be generated in conjunction with the collection and testing of each urine. specimen.
Less frequent creation of records or generation of reports could invalidate the testing process.
8.
Circumstances Which Justify Variations From OMB Guidelines This amended rule does not impose requirements that vary from OMB guidelines.
9.
Consultation Outside the NRC The NRC received public comment on the proposed rule.
- 10. Confidentiality of Information The licensee is required to maintain a system of files and procedures for the protection of the personal information under Section 26.29(a).
In addition, personal and sensitive information will not be reported to the NRC by the licensee.
i
- 11. Sensitive Ouestions Each licensee is required to collect personal information to comply with the Part 26 fitness-for-duty requirements. This information is necessary to ensure that personnel are not under the influence of any substance and are not mentally or physically impaired. However, Section 26.29(a) requires that licensees maintain a system of files and procedures for the protection of the personal information i
collected from facility personnel.
- 12. Estimate of the Cost to the Federal Government The reduction in the random drug testing rate will not result in any significant cost reduction or increase for the Federal government.
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- 13. Estimate of Industry Burden and Costs a.
The burden of information collection and reporting is described below.
Licensees have reported a total of approximately 262,000 tests of all types in 1991 and approximately 266,000 in 1992.
Approximately 100,000 of trese tests each year are random tests of licensee employees and 50,000 are random tests of contractors and vendors. A 50 percent reduction in the random testing rate, as permitted by the amended rule, would reduce the number of tests by approximately 76,000 per year. This includes a total of 1,800 employees at two nuclear fuel facilities.
The reporting of test results by the certified laboratory including validation reviews and the creation of collection records such as the chain-of-custody forms and the permanent record book, are estimated to take 13 minutes per specimen.
These information collection requirements are contained in Appendix A to Part 26.
The tutal burden reduction for industry is estimated to be 16,467 hours0.00541 days <br />0.13 hours <br />7.721561e-4 weeks <br />1.776935e-4 months <br /> (76,000 x 13 minutes). An average of 223 hours0.00258 days <br />0.0619 hours <br />3.687169e-4 weeks <br />8.48515e-5 months <br /> of burden reduction is estimated per site (16,467 + 74).
The number of reports by the certified laboratories will actually be less than the number of specimens collected because of onsite testing at approximately one-third of the sites. At those sites, the licensees would generate the record of a negative test; no appreciable savings in reporting and recordkeeping would accrue.
Licensees currently have fitness-for-duty programs in place that adhere to 10 CFR Part 26.
These programs include written policies and procedures and contract provisions which establish fitness-for-duty agreements between the licensee and contractor; other than minor edits to accommodate the reduced random testing rate, no changes are anticipated to those documents.
b.
Source of Burden Data and Method for Estimating Burden Burden estimates are based, in patt, upon discussions with ruclear utility employees and on estimates of NRC personnel familiar with those types of records and reports.
- 14. Reasons for Chance in Burden The amended rule permits licensees to reduce the random testing rate for licensee, contractor, and vendor employees.
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- 15. Publication for Statistical Use t
The NRC has published information concerning program performance in NUREG/CR-5758, " Fitness for Duty in the Nuclear Power Industry -
Annual Summary of Program Performance Reports," Volumes 1, 2, and 3.
f B.
COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Statistical methods are not required in the 10 CFR Part 26 information collection provisions.
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[7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Part 26 RIN 3150-AE38 Modifications to Fitness-For-Duty Program Requirements AGENCY:
Nuclear Regulatory Commission.
ACTION:
Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations governing fitness-for-duty (FFD) programs that are applicable to licensees who are authorized to construct or operate nuclear power reactors and to licensees authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM). The amendment permits licensees to reduce the random testing rate for all persons covered by 10 CFR Part 26 to an annual rate equal to 50 percent.
EFFECTIVE DATE: January 1, 1994 FOR FURTHER INFORMATION CONTACT: Loren L. Bush, Jr., Safeguards' Branch, Division of Radiation Safety and Safeguards, Office of Nuclear Reactor i
l l
A
i Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555, j
telephone:
(301) 504-2944.
l e
AVAILABILITY OF DOCUMENTS:
i t
'l Copies of the regulatory analysis, the comments received, and the i
l Government Accounting Office (GAO) report (GA0/GGD-93-13) of November 1992 may l
be examined at the NRC Public Document Room, 2120 L Street NW, (Lower Level),
t Washington, DC.
t Copies of NUREG-1354, NUREG/CR-5758 (Volumes 1,2, and 3), and NUREG/CR-5784 may be purchased from the Superintendent of Documents, j
U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082.
l i
Copies are also available from the National Technical information Service, l
5282 Port Royal Road, Springfield, VA 22161. A copy is available for inspection and/or copying for a fee in the NRC Public Document Room, 2120 L Street NW, (Lower Level), Washington, DC.
SUPPLEMENTARY INFORMATION:
Background
1 The NRC has reviewed experiences gained since publication of the current FFD rule on June 7,1989 (54 FR 24468), and implementation by power reactor licensees on January 3, 1990, and determined that it may be appropriate to modify the random testing rate. Accordingly, on March 24, 1993 (58 FR 15810),
the Commission published a proposed modification to the FFD rule that would t
w
.m.,
,l permit a reduction in the random testing rate for licensee employees, but maintain the 100 percent random testing rate for contractors and vendors.
Summary of Public Comments The comment period expired on June 22, 1993.
Forty comment letters were received.
Twenty-eight were from power reactor licensees, six from unions, one from an industry association, one from a vendor, three from licensed reactor operators, and one from a private citizen. There was averwhelming support for the proposed reduction in the annual rate of random testing for licensee employees.. Most of the commenters believed that the reduced rate also should apply to contractors and vendors, and several commenters proposed a flexible, performance-based rate. There was no support for excluding _from any reduction in the random testing rate certain positions critical to the safe operation of a nuclear power plant, such as licensed reactor operators.
A summary of the comments received and the NRC's responses are presented below.
1.
Comment. The random testing rate for licensee employees should be reduced to 50 percent.
All of the 23 commenters submitting comments on the Commission's proposed reduction of the random testing rate to 50 percent for licensee employees supported the proposal. The reason most often expressed was the low rate of positive random test results experienced by licensee employees, particularly in comparison with other industries having.significant safety concerns. These commenters believe that this low industry-wide positive rate justifies the lowering of the random testing rate to 50 percent.
Some commenters stated that t 50-percent rate for licensee emplcyees would make that rate consistent with the random testing rate currently required in the substance abuse programs mandated for entities regulated by the agencies within the Department of Transportation (D0T), including the Federal Aviation Administration and the Federal Highway Administration.
They also noted that DOT is currently considering lowering its proposed random testing rate below 50 percent even though Federal Highway Administration data, for example, indicate a significantly higher positive rate than that experienced among NRC licensee employees.. Another commenter pointed out that the lowered random testing rate for licensee employees subject to the NRC's FFD rule also would be consistent with the random rate applied in the Commission's own internal drug testing program.
Other commenters supported the reduction with the expectation of significant cost savings for licensees as a result of only testing approximately one-half the number of employees now being tested.
In this regard, the Nuclear Management and Resources Council (NUMARC) made reference to the November 1992 GA0 report, " Employee Drug Testing: Opportunities Exist To Lower Drug-Testing Program Costs" (GA0/GGD-93-13). which suggests reduced random testing rates as a means of producing cost efficiencies in Federally mandated drug testing programs without adversely affecting program integrity.
Concerning the relative effectiveness of alternative random testing rates, some commenters believe that a 50-percent random testing rate would produce satisfactory deterrence of drug and alcohol abuse.
This is
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particularly true in light of the fact that' other FFD program elements, such l
t as program awareness training and benavioral observation, and the access authorization program will continue to inhibit such behavior. Two commenters l
also supported the proposed change because it would lessen the disruption of f
1 workers lives and reduce the invasion of privacy that random drug testing creates.
I t
NRC Response a
a j
o The NRC concurs with those commenters who stated that a 50 percent random testing rate as applied to licensee employees can be expected to provide i
sufficient deterrence to justify lowering the rate at this time.
It also l
agrees with the observation that the access authorization program and other 4
FFD program elercants, such as policy communications and awareness training, j
behavioral observation, for-cause testing, employee assistance programs, and i
the imposition of strict sanctions for violations of an FFD policy will j
continue to deter drug and alcohol abuse by most of the workforce. As some commenters noted, requiring fewer tests of licensee employees should decrease the privacy invasion experienced by some employees.
It also should result in cost savings across the industry by reducing lost work hours and the number of tests to be administered.
The Commission recognizes that positive results in the nuclear power industry's random testing are generally among the lowest of any U.S. industry, Nonetheless, it realizes that there are many variables that can affect the l
t rate of positive testing results and that relatively low positive test results, by themselves, are not the only indicator of the effectiveness of a. - -~
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i testing program either on an industry-wide or a licensee program level.
Some of the variables that could affect the testing results are the propensity of.
the population being tested to use drugs and alcohol, the effectiveness of I
other program elements, and the extent to which tested employees have been j
successful in subverting the testing process and avoiding detection, f
The NRC does not have sufficient information about these or other factors.
r that may infitence testing results to be able to determine that the decreasing positive rates reported by licensees are an unqualified indication of FFD
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program effectiveness. Nonetheless, the Commission is gratified to observe
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the continuing downward trend in licensee employees' positive random test f
l results during the past three years. The recently published NUREG/CR-5758, 1
i Volume 3, " Fitness for Duty in the Nuclear Power Industry: Annual Summary of Program Performance Reports," indicates that licensee employees' positive j
i random testing rate in 1992 was 0.20 percent as compared to 0.28 percent in l
1990 and 0.22 percent in 1991. There has been a corresponding downward trend j
in the positive rates for random testing of contractor and vendor personnel, viz., 0.56 percent in 1990, 0.55 percent in 1991, and 0.45 percent in 1992.
In making its decision, the Commission has considered these testing results along with the apparent continuing strength of the other elements of most licensees' FFD programs, the reduced invasion of employees' privacy l
interests, and the potential for cost savings.
In light of this industry 1
experience and of these beneficial effects, the Commission has concluded tha, it is reasonable at this time to lower the random testing rate for licensee i
j employees and contractor and vendor personnel to 50 percent. The response to t
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Comment 4 discusses the Commission's reasons for allowing reduction in the I
random testing rate for contractor and vendor personnel.
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2.
Comment. The random testing rate should be reduced to less than 50
-l percent.
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i Four commenters recommended that the random _ testing rate be reduced to j
less than 50 percent. The rates they recommended varied from 5 percent to 25 percent. Their central argument was that the random testing rate can be j
lowered substantially without threatening the effectiveness of the program.
l The very low rates of drug and alcohol positive tests that have been recorded by the r,uclear industry during the first two years of FFD program operations l
l are the basis for their recommendation. One licensee stated that most chronic drug users probably-have been eli'ainated and currently there is not a serious drug or alcohol abuse problem in the industry. This commenter and NUMARC also cited the GAO study that found that the percentage of positives does not vary i
I significantly amorg Federal agency drug testing programs, regardless of what i
random rate is used. Another licensee emphasized that behavioral observation, i
not random testing, is the most potent tool in detecting drug abuse. - Another commenter recommended that the NRC consider further reductions because the i
l effectiveness of other program elements makes a random rate of even 50 percent i
unnecessarily high.
l Significant cost savings was given as the most compelling reason to reduce the random rate below 50 percent. One licensee estimated the industry 1
would save up to $30 million annually without degradation of the overall i
I program.
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NRC Response
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As stated in the response to Cottment I above, positive random testing results are not, by themselves, the only indicator of the FFD program's I
effectiveness in detecting substance abuse. Therefore, the Commission believes that the industry's relatively low numbers of drug and alcohol j
3 positive random test results should not be used as the sole justification for
[
lowering the random testing rate below 50 percent.
If the Commission were to reduce the random testing rate based solely on positive test results, it could reward licensees whose FFD programs are not fully effective. While behavioral observation and for-cause testing are valuable program elements, there still j
l must be a strong random testing program that provides an adequate level of
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detection and deterrence.
The Commission continues to believe that it must choose a conservative and prudent random testing rate that maximizes both i
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detection and deterrence of substance abuse while minimizing the monetary and
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social costs of such testing. The Commission believes that a 50-percent 1
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random testing rate will strike the proper balance between the dictates of
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i public health and safety, the financial needs of licensees, and the privacy l
i I
j and other interests of workers subject to the testing requirement.
Given the j
substantial unknowns currently associated with the true. detection and 4 -
deterrence effectiveness of alternative random testing rates as applied to the i
particular conditions of the nuclear power industry workforce, the Commission
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believes that it cannot establish a random testing rate lower than 50 percent a
for any segment of the industry at this time.
l It should also be noted that relatively low positive test rates do not I
necessarily indicate that there is not a drug and alcohol abuse problem, as i
some commenters asserted.
First, some users have become adept at avoiding l
detection, and the use of increasingly effective subversion techniques may be i
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one reason why random testing results are decreasing. Second, while it may be j
t that most of the chronic drug users who were in the industry when the program j
started have been detected or have left, there can be expected to be a f
i continuing level of intermittent illegal drug use and alcohol abuse among-industry employees; uch use is difficult to detect. The Commission concludes
- i that the low positive random test results do not indicate that there has I
ceased to be a drug and alcohol abuse problem and that further reduction in i
the random testing rate would not be appropriate at this time.
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i.
In response to the commenters' reference to the GA0's observation that I
the percentage of positives does not vary significantly among Federal agency drug testing programs, the NRC notes that the GA0's objective in that report was to identify potential cost savings in Federal employee drug testing programs.
Its objective did not include determination of the relative deterrent values of alternative random testing rates.
In accomplishing its objective, the GA0 properly concentrated on only the costs associated with 3
4
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Federal employee drug testing.
It did not perform an indepth analysis of the j
t j
several variables that influence testing results nor of the very complex j
i relationship between those variables and the deterrence value of testing.
l Such variables would include the inclination for drug or alcohol abuse among-l I
the employees in the various industries in which the Federal testing programs operate, the extent to which the strength and effectiveness of other, non-l a
l j
testing program elements, such as drug awareness training, may affect testing j
results, and the relative stringency of sanctions imposed by the various j
Federal agencies following positive test results. Because the GA0's objective i
was to address the cost rather than tne deterrence effectiveness of testing, l
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) !
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'I the NRC does not consider the commenter's reference to the GA0's observation i
'f to be a persuasive argument for reduced random testing rates.
The NRC will continue to monitor implementation of the rule and will modify i
the rule in response to industry experience, advances in technology, or other considerations to ensure that the rule is achieving the general performance
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objectives set forth in 10 CFR Part 26.
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3.
Comment. The random testing rate should be flexible and based on l
performance, such as the positive rate of random testing.
I Twelve commenters recommended that the Commission allow some form of performance-based approach to determine the random testing rate. Under such a t
system, the random testing rate would vary over time. This would depend on each licensee's or, alternatively, the industry's positive random test results from a previous period. One licensee, for example, suggested that each i
licensee's random testing rate should be based upon that particular licensee's l
previous 12-month testing results. Under this approach, a licensee would be j
subject to a minimum 50-percent random testing rate if it experienced a-j i
I positive rate of greater than 0.50 percent during the previous 12 months.
That licensee could reduce its random rate to 25 percent if it subsequently t
had a 12-month positive rate between 0.25 percent and 0.50 percent or to as
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low as 10 percent if its positive rate for the previous year was less than O.25 percent. Three other licensees recommended similar schemes whereby a licensee's random rate would be determined by its own record of positive test i
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I results. One of these recommendations based the rate on the results of the previous 2 years rather than those of the previous 12 months.
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NUMARC proposed that the industry-wide random testing rate.be determined by the industry-wide random testing results from the previous period.
This recommendation was endorsed by five licensees. Under NUMARC's proposed approach, the industry would be allowed by regulation to adjust its random l
t' testing rate based on testing results from the previous reporting period. All licensees would be required to test at a 100 percent random rate if the industry-wide positive rate were greater than 1.0 percent in the previous j
period, at a 50-percent random rate if the positive rate was between 0.50 l
percent and 1.0 pertent, at a 25-percent random rate if the positive rate was l
between 0.25 percent and 0.50 percent, and at a 10 percent random rate if the I
positive rate was less than 0.25 percent. Two of the eleven licensees j
i favoring a performance-based testing system provided a general recommendation o
i that did not specify whether the random testing rate should be based on the
{
j positive testing results of each individual licensee, or on the results of the j
industry as a whole.
The commenters noted various potential advantages of adopting a
]
performance-based approach to setting the random testing rate. One stated i
that adopting such an approach would be consistent with the NRC's initiative I
j to identify performance-based programs that would be beneficial to the l
industry. Another listed cost savings, equity in that each licensee's random i
i rate would be commensurate with its program performance, and an incentive for I
licensees to maximize program conformance with the FFD rule as advantages of 4
such an approach.
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NRC Response During development of 10 CFR Part 26 in 1989, the Commission considered a variation of the flexible, performance-based random rate similar to the approaches recommended by these commenters.
(See, for example, the NRC's response to Comment 7.4.2 in NUREG-1354, "F ' ness for Duty in the Nuclear
]
I Power Industry: Responses to Public Comments.") At that time, the Commission decided against adopting a performance-based rate for various reasons. As i
stated above, positive random testing results are not the only indicator of i
detection and deterrence effectiveness or of overall random testing program l
performance to allow the testing rate to vary with testing results.
It is j
1 possible, for example, that particular licensees can experience low or l
declining positive random testing rates because of FFD program deficiencies.
i Adopting an approach that allowed such licensees to reduce their random testing rates as their positive results declined would, in effect, reward deficient program performance.
It also would tend to penalize licensees that i
maintain aggressive programs that continue to show relatively high positive random testing results.
[
i Adopting a performance-based approach also would tend to discourage the j
i initiatives that the Commission is encouraging in 10 CFR 26.24(b) and in Section 2.1 of Appendix A to Part 26.
In S 26.24(b), the NRC allows licensees to implement programs with more stringent standards, for example, lower
{
screening and confirmation cutoff levels than those specified in the rule.
In Section 2.1 of Appendix A, licensees are permitted to test for any illegal j
i drugs during a for-cause test or analysis of suspect specimens and are j
encouraged to test for ph, specific gravity, creatine, and adulterants. :
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Program performance data.for the first three years of FFD program q
i implementation have shown that those licensees using screening cutoff leve i
'{
for marijuana that are lower than the maximum allowed 100 nanograms per 4
{
milliliter (ng/ml) have had a higher percentage of confirmed positive results i
than those screening at 100 ng/inl.
(See NUREG/CR-5758, Vols. 1-3.)
Licensees
'I i
that em91oy special measures to detect attempts to' dilute specimens or flush 4
metabolites from the body report that their positive rate is about doubled.
k This result is similar to data presented to the U.S. Department of Health and i
}
Human Services' Drug Testing Advisory Board on June 10, 1993, and reported in i
"The National Report on Substance Abuse" on June 18, 1993.
(The study is
}
currently undergoing peer review before publication.)
t Adopting a
{
performance-based approach that allowed licensees to reduce their random testing rates as positive testing results declined would likely discourage f
licensees from adopting lower screening cutoff levels and' taking measures to j
detect attempts by users to avoid detection, t
i Lastly, the Commission recognizes that such a performance-based approach could create conditions that may be conducive to manipulation of random i
testing results in order to gain the financial benefits that would b'e associated with lower random testing rates. ' Measures to discourage and detect
]
such practices would be burdensome to both licensees and the NRC and could tend to discredit the FFD program.
For all these reasons, the Commission declines to-adopt a l
performance-based i
approach to setting the random testing rate.
The reduction in the random testing rate should be
)
4.
Comment.
applied to all workers.
I
-Four of the 30 commenters on this issue - three unions and one licensee f
- supported the Commission's proposal that licensees maintain the 100-percent j
random testing rate for contractor and vendor employees.
Their reasons included a concern for lack of commitment by contractor employees to t
i maintaining the industry's high drug-free standard and the need for the higher testing rate to provide continued deterrence for contractor employees. One of
{
the three unions recommended that long-term contractors should have the same r
lower random testing rate as that of licensee employees because test results of long-term contractors and licensee employees have been almost identical There were several issues consistently mentioned by those 26 commenters who opposed maintai'ning the 100-percent random testing rate for contractor and vendor employees. There was a general concern for unnecessary inconsistencies 1
in random testing rates between Federal agencies. Commenters recommended that
~
the NRC program be kept as consistent as possible with programs in other Federally regulated safety-related industries. These include the DOT programs that currently require contractors and vendors to be randomly tested at a-50-percent rate.
Various licensees cited the testing results.from 1990 and 1991 which, in I
their opinion, create no statistically sound rationale for testing contractor and vendor employees at a rate different from that of licensee employees.
They argued that, while the contractor / vendor positive testing rate has been i
twice that of licensee employees, it is still low enough to make unnecessary the expenditure of the resources necessary to maintain two separate random testing pools.
5 Various commenters noted that contractors and vendors are subject to the identical access authorization and other FFD program requirements as are i
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licensee employees, including behavioral observatian. 'These stringent requirements, in their view, obviate the need to keep the contractor / vendor j
~
random rate at 100 percent.
Some also noted that the deterrent value of I
random testing is in the act of testing itself and not in what many consider
{
to be a high rate of testing.
Some commenters warned that keeping contractors l
and vendors at 100 percent could be construed as discriminatory against those j
employees and may be perceived as punitive rather than as a corrective
)
r measure. Two licensees also cited a study of the detection effectiveness of I
nine random testing rates published in NUREG/CR-5784, " Fitness for Duty in the l
l Nuclear Power Industry: A Review of the First Year of Program Performance and on Update of the Technical Issues," which indicates that a 100-percent testing rate is only a little more effective than a 50-percent rate for detecting occasional drug users.
j i
4 NRC Response Although there is a difference in the positive results of random testing l
?
between licensee ecolayees and contractor and vendor employees, there is a j
i general downward trend of the results of random testing, as stated in the response to Comment 1 abov0.
Therefore, the NRC agrees with those commenters i
who contend that the tetting results during the past three years do not l
'f justify making a distinction between these groups insofar as the random testing rate is concerned. Although the contractor / vendor random testing I
positive rates continue to be about twice the rate for licensee employees, the Commission agrees that the actual numbers of positive test results of all
)
categories of nuclear power workers are low, other program measures such as 4
6 I
- _ _... ~. - _. _.. _.. -......, -
. _ = -
more stringent sanctions tend to screen out problem workers, and the potential threat to public health md safety posed by most contractors and vendors is f
generally less than posed by licensee employees because they are usually working on site only when the reactor is shut down.
l In this same vein, the Commission recognizes that the percentages of contractor and vendor positive random testing results are low compared to the.
t percentages of positives in other industries.
For example, the i
contractor / vendor positive rate is approximately one-quarter that of railroad t
industry employees. Therefore, the Commission will permit its licensees to f
lower the random testing rate to 50 percent for all persons covered by 10 CFR t
Part 26.
However, the Commission will continue to monitor licensee program j
t performance and effectiveness and will.aake program adjustments as necessary.
j In response to the comments regarding the study of the detection 4
effectiveness of nine random testing rates published in NUREG/CR-5784, the j
Commission notes that the study explicitly dealt with only the hypothetical I
detection effectiveness cf those alternatives.
It did not address their a
relative deterrence effectiveness. The NRC continues to believe that the effectiveness of a 100 percent random testing rate for_ deterring occasional J
drug users could be slightly higher than that of a 50-percent rate.
i Nonetheless, the Commission believes that a 50-percent random testing rate j
i will provide sufficient deterrence to drug and alcohol abuse by contractor and
{
vendor employees.
i The Commission also does not agree that the random testing rates in all Federal drug testing programs should be identical and, as such, appear to be j
" consistent" with each other. The Commission continues to believe that the i
i random test rate for employees in the nuclear power industry need-not be t <
b i
similar to the rates applied to employees in all, or even most, other Federal f
agencies or Federally mandated programs. Not all Federal agencies have identical safety concerns or responsibilities. Due to the very substantial public health and safety consequences that could be associated with a serious t
event at a nuclear power plant, the Commission believes that it must continue j
to set stringent standards for this industry's FFD programs and that random testing rates required of-NRC licensees are, indeed, appropriately consistent with the random rates required by other Federal agencies in relation to their public health and safety responsibilities.
5.
Comment. There should be no difference in the random testing rate l
q for certain-positions critical to the safe operation of a nuclear power plant.
Seventeen commenters responded to the Commission's question as to whether certain positions critical to the safe operation of a nuclear power plant, such as licensed reactor operators, should be excluded fro 3 a.iy reduction of the random testing rate. All these commenters recommended against such differentiation.
Two licensees stated that treating people in positions critical to safety differently from other employees couk' have a
'j negative effect on the morale, self-image, and motivation of ' 4 r,r ap of l:t highly trained and dedicated specialists. Another stated that
. plant l
r employees are critical to safe operatien.
Therefore, a reduction in the random testing rate should apply to all employees. The potential for added l
record-keeping requirements creating unnecessary burdens for the industry was another reason for not making this distinction.
In the opinion of one f
commenter, the 1990-1992 industry-wide program performance data do not support -
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testing people in positions critical to safety at a different rate than that
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applied to other licensee employees.
Finally, one licensee cited potential I
problems getting union agreement to testing this classification of employees at a higher rate than other licensee personnel subject to the FFD rule.
[
t NRC Response The essence and unanimity of these comments -- that licensed operators
}
and other employees in positions critical to the safe operation of a nuclear i
power plant should not be excluded from a reduction of the random testing rate f
-- is not surprisin'. These particular members of the nuclear power g
industry's workforce have collectively demonstrated their dedication to safe i
and efficient plant operations. As at least one commenter noted, the industry's program performance data for the first three years of operation do not support differentiating between people in safety-critical positions and'
-f other licensee employees insofarias the random testing rate is' concerned. The 1992 program performance data, for example, show that only eighteen of the i
?
industry's approximately 5,000 licensed operators tested positive for drugs or alcohol. While the NRC expects licensees to continue to take action to drive this number of positives down even further, this record does not merit testing j
people in these positions at a rate different from that applied to other i
licensee employees. The Commission, therefore, concurs with the commenters recommendation that certain positions critical to the safe operation of a I
nuclear power plant, such as licensed reactor operators, should not be excluded from a reduction of the random testing rate.
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6.
Comment.
Random testing is extensive, produces false positives, and chronic users are able to avoid detection.
Two commenters, a power plant worker and a union, argued against the usefulness of continued random testing.
One of these commenters stated that random testing produces false positives. These cost the industry large amounts of money in settlements and damage the public's perception of licensees' fairness.
As additional support for this position, this commenter warned that chronic drug abusers are particularly adept at escaping detection from random testing by subverting the testing process.
The other commenter recommended that random testing be eliminated because it is not effective in identifyina workers who are impaired at the time urine samples are collected.
For-cause testing, in this commenter's opinion, is more effective because it more accurately reflects a worker's present ability to perform his/her job at toe ti.
he/she is tested.
This commenter also stated that random testing appears to be a means of having the NRC enforce the Controlled Substances Act which is not the NRC's responsibility.
NRC Response The Commission has long been well aware of the types of FFD program-related concerns as addressed by these commenters. During the promulgation of 10 CFR Part 26 in 1989, the Commission fully addressed these and many other such concerns.
(See NUREG-1354, " Fitness for Duty in the Nuclear Power Industry:
Responses to Public Comments.") At that time the NRC concluded, for example, that licensee FFD programs should be cdf'terned not only with 4
i i
-t impairment, but also with worker reliability and trustworthiness. The NRC l
believes that any illegal drug use or alcohol abuse by a worker reflects upon.
his or her trustworthiness and reliability.
Likewise, random testing is not l
intended, nor has it ever functioned, as a means to enforce the Controlled
{
Substances Act.
Section 26 29(b) provides that licensees, contractors, and vendors shall not disclose test results to law enforcement officials unless those officials request such information under court order.
It also is noted that there is no requirement to routinely provide such officials with testing l
results.
The Commission is well aware that there is a potential for false.
positive results and, therefore, has required numerous quality control measures and safeguards to prevent such occurrences.
In Appendix 0 to NUREG/CR-5758, Volume 3, the testing process errors that were reported by f
licensees during the first three years under the FFD rule were analyzed. Of 1
over 800,000 specimens tested, there were two false positives of personnel t
specimens reported by the laboratories, both due to administrative errors.
In
{
i 4
both cases, the quality assurance programs detected and corrected the problem.
[
Because of the NRC's particular concern with the degree to which the testing process can be subverted, the Commission staff has continued to-track the ways in which workers have subverted testing processes in industries i
across the country.
These efforts have resulted in staff recommendations for amending 10 CFR Part 26 to introduce various means for combatting subversion.
Lastly,- the Commission believes that the.added protection of public health and safety that the FFD program provides is well worth the industry's costs of administering this program.
?
o 7.
Comment. Maintaining two separate populations of workers for random testing is an unnecessary and expensive burden.
[
t Some of the commenters stated that requiring two random testing rates r
would force licensees to develop two separate testing programs. The resulting additional administrative and financial burdens would cancel out any savings f
resulting from reducing the licensee employee rate to 50 percent. NUMARC stated that the industry would save approximately $4.1 million if the number of tests of contractor and vendor employees was cut in half.
t NRC Response f
Some of the comments noted above asserted that separat' random testing j
rates for licensee employees and contractors / vendors would create additional administrative and financial burdens for licensees. Although this issue is somewhat moot since the Commission will permit licensees to reduce the random
-j testing rate to 50 percent per year for all persons covered by Part 26, the Commission does not concur that conducting random testing using two random f
rates will t&use appreciably higher administrative or operating costs.
Presumably, most licensees' data bases already distinguish between licensee i
employees and contractor / vendor employees subject to testing. Numerous j
i commenters on the initial rule in 1989 indicated that-the workforce population should be separated so that permanent employees would not be tested at a much j
higher rate to make up for contractors who might not be on site when selected for testing (see comment / response 7.4.3 of NUREG-1354). The NRC staff I
understands that several licensees have divided their testing population as l
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permitted by the rule.
The number and identity of licensee employees in the testing pool remains rather constant over time. The number and identity of coi; tractor / vendor employees in the testing pool, on the other hand, varies quite considerably over time depending on outages and other operational considerations. A licensee may choose to create more than one test population so that it may test portions of its workforce at a greater rate or reduce the burden on its employees from being tested at a higher rate to compensate.for the testing of contractors and venaars not normally on site.
i i
8.
Comment. The Commission should modify certain portions of 10 CFR i
Part 26 based on industry experience and lessons learned and incorporate numerous prdgram enhancements as discussed at various industry forums.
f Eight commenters recommended that the Commission make future.
f t
modifications to certain portions of 10 CFR Part 26 based on industry y
experience and lessons learned and incorporate numerous program enhancements as discussed at various industry forums.
NRC Response The specific recommendations for ways in which Part 26 can be improved and numerous other program enhancements are currently being considered by the NRC in conjunction with a general package of rule revisions currently under j
development.
l
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l Environmental Impact: Categorical Exclusion The NRC has determined that this final rule is the type of action i
described in categorcal exclusion 10 CFR 51.22(c)(2. Therefore, the NRC has not prepared an environmental impact statement, nor an environmental assessment for this final rule, t
Paperwork Reduction Act Statement This final rule amends information collection requirements that are j
subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.) These requirements and amendments were approved by the Office of Management and Budget, approval number 3150-0146.
Since the rule will permit licensees to reduce the random testing rate for their employees, the resulting reduction in the reporting and recordkeeping burden is expected to be an average of 223 hours0.00258 days <br />0.0619 hours <br />3.687169e-4 weeks <br />8.48515e-5 months <br /> per site,
'f including the time for reviewing instructions, searching existing data j
i sources, gathering and maintaining the data needed, and completing and 9
reviewing the collection of information. Send comments regarding this burden j
estimate or any other aspect of this collection of information, including i
suggestions for reducing this burden, to the Information and Records i
Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Desk Officer, Office of Information and Regulatory l
l Affairs, NE0B-3019 (3150-0146), Office of Management and Budget, Washington, j
i DC 20503.
j
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Regulatory Analysis l
The NRC has prepared a regulatory analysis for this regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The analysis is available for inspection in the NRC Public i
Document Room,-2120 L Street NW (Lower Level), Washington, DC. Single copies of the analysis may be obtained from Loren L. Bush, Jr., Division of Radiation l
Safety and Safeguards, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 504-2944.
'i Regulatory Flexibility Act Certification In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule will not have a significant l
economic impact on a substantial number of small. entities. This' rule affects i
only the licensing and operation of nuclear power plants and activities l
f associated with the possession or transportation of Category I material The companias that own these plants do not fall within the scope of the definition j
of "small entities" set forth in the Regulatory Flexibility Act or the Small Business Size Standards issued by the Small Business Administration in 13 CFR j
Part 121.
Backfit Analysis l
The rule represents a relaxation from current Part 26 requirements for drug testing since the rule permits (but does not require) licensees to reduce j
- j i
w.
the random testing rate for all persons covered by the rule.
Accordingly, the rule does not represent a backfit as defined in 10 CFR 50.109(a)(1), and a backfit analysis is not required for this rule.
-I l
List of Subjects in 10 CFR Part 26 i
Alcohol abuse, alcohol testing, appeals, chemical testing, drug abuse, drug testing, employee assistance programs, fitness for duty, hazardous i
materials transportation, management actions, nuclear materials, nuclear power plants and reactors, penalties, protection of information, radiation i
protection, reporting and recordkeeping requirements, sanctions, special e
i J.
nuclear materials.
1 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, I
as amended, and 5 U.S.C. 553, the NRC is adopting the following amendment to j
l 10 CFR part 26.
i i
i Part 26--Fitness for Duty Programs
!i 1.
The authority citation for Part 26 continues to read as follows:
?
E Authority: Secs. 53, 81, 103, 104, 107, 161, 68 Stat. 930, 935, 936, e
937, 939, 948, as amended (42 U.S.C. 2073, 2111, 2112, 2133, 2134, 2137, 2201); sets. 201, 202, 206, 88 Stat. 1242, 1244, 1246, as amended (42 U.S.C.
5841, 5842, 5846).
2.
In S 26.24 paragraph (a)(2) is revised to read as follows:
i !
f l
i
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i S 26.24 Chemical testing i
(a) * * * *
(2) Unannounced drug and alcohol tests imposed in a statistically random I
and unpredictable manner so that all persons in the population subject to l
C testing have an equal probability of being selected and tested.
The tests l
must be administered so that a person completing a test is immediately
{
eligible for another unannounced test. As a minimum, tests must be administered on a nominal weekly frequency and at various times during the day.
Random testing must be conducted at an annual rate equal to at least 50 percent of the workforce.
i r
i t
Dated at Rockville, Maryland, this day of
, 1993.
t l
For the Nuclear Regulatory Commission i
Samuel J. Chilk, f
Secretary of the Commission.
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_{7590-01]
U.S. NUCLEAR REGULATORY COMMISSION Documents Containing Reporting or Recordkeeping Requirements Office of Management and Budget (OMB) Review AGENCY:
U.S. Nuclear Regulatory Commission (NRC)
ACTION:
Notice of the OMB review of information collection.
SUMMARY
- The NRC has recently submitted to the OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1980 (44 U.S.C. Chapter _35).
1.
Type of submission, new, revision, or extension:
Revision.
2.
The title of the information collection:
Final Rule, "10 CFR Part 26:
" Modifications to Fitness-For-Duty Program Requirements."
3.
The form number if applicable:
Not applicable.
4.
How often the collection is required: On occasion.
5.
Who will be required to report: Nuclear power plant licensees and licensees who are authorized to possess. use, or transport formula quantities of strategic special nuclear material.
i 9
6.
An estimate of the number of reports annually: A reduction of 76,000 drug tests and associated records.
l 7.
An estimate of the total number of hours needed annually to j
complete the requirement:
16,467 hours0.00541 days <br />0.13 hours <br />7.721561e-4 weeks <br />1.776935e-4 months <br /> of burden reduction (an average of 223 hours0.00258 days <br />0.0619 hours <br />3.687169e-4 weeks <br />8.48515e-5 months <br /> of burden reduction per site).
8.
An indication of whether Section 3504(h), Pub. L.96-511 applies: Applicable.
9.
Abstract:
10 'CFR Part 26 of NRC's regulations, " Fitness-for-Duty Programs," requires licensees authorized to construct or operate a nuclear power reactor and licensees authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM) to implement fitness-for-duty l
programs to assure that personnel are not under the influence of any substance or mentally or physically impaired, to retain certain records associated with the management of these programs, and to provide reports concerning significant events.
An amendment to this regulation permits licensees to reduce the random testing rate of their employees and contractor and vendor employees for drugs and alcohol to 50 percent. The t
requirements of Part 26 are mandatory for the affected licensees.
l 2
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,.o Copies of the submittal may be inspected or obtained for a fee from the NRC Public Document Room, 2120 L Street, NW. (Lower Level),
Washington, DC 20555.
Comments and evestions should be directed to the OMB reviewer:
Tim Hunt Office of Information and Regulatory Affairs (3150-0146)
NE0B-3019 Office of Management and Budget Washington, DC 20503 Comments can also be submitted by telephone at (202) 395-3084.
The NRC Clearance Officer is Brenda Jo. Shelton, (301) 492-8132.
Dated at Bethesda, Maryland, this
- day of M = d"/, 1993.
Fo he Nuclear Regulatory Commission K
c
/
Gerald F. Cranford
)
Designated Senior Official for Information Resources Management 9
P a