ML20029E211
| ML20029E211 | |
| Person / Time | |
|---|---|
| Issue date: | 09/25/1989 |
| From: | Grimes B Office of Nuclear Reactor Regulation |
| To: | Conran J Committee To Review Generic Requirements |
| Shared Package | |
| ML20029E210 | List: |
| References | |
| NUDOCS 9405170243 | |
| Download: ML20029E211 (133) | |
Text
= --
/p* **o q'o u
UNITED STATES
!", s 9 NUCLEAR REGULATORY COMMISSION 3/
WASHINGTON, D, C. 20555 J
E O
Vv*... /
SEP 2 5 ;m NOTE T0: Jim Conran, CRGR FROM:
Brian Grimes, DRIS, NRR
. SUE. JECT:
FFD IMPLEHEHTATION NUREG ERRATA
~
After the NUREG was forwarded to the CRGR it was noted that the draft document contains the following errors:
The answer to 10.2 should end with... granted unescorted access.
o Ti.e second sentence of the answer to 6.15 should begin with: This course o
of action was adopted as...
A few of the referenced discussions need to be renumbered as follows:
o Q/A N0.
REFERENCED NO. CHANGED TO j
6.3 6.12 to 6.13 10.6 6.13 to 6.14 10.8 6.8 to 6.9 and 6.13 to 6.14 Ke are proposing that two new questions and answers be added:
2.7 Must corporate officials who would respond to the EOF or TSC be (new) required to abstain from alcohol at all times or during scheduled work, or does the abstention requirement apply at all when there is no anticipated response to the EOF or TSC7 ANSWER:
The abstention requirements of Section 26.20(a) pertain to working tours within the protected area or at the EOF or TSC. Corporate officials are not required by the rule to abstain from alcohol simply because they may be called to the EOF or TSC. Should they be called in, the procedural requirements of 26.20(e) apply.
Similarly, other licensee employees and contractor and vendor employees (under Section 26.23) are not required by the rule to abstain from alcohol when not scheduled to work within the protected area or at the EOF or TSC.
9405170243 891018 PDR REVGP NRCCRGR to Enclosure 2 tEETING170 PDR
l l
l Jim Conran l 5.20 If a licensed operator is selected for random testing and the (new) temporary absence from the control room at that time could cause l
a potential. safety problem,'what may the licensee do?
ANSWER:
The licensee in this case may wait until the seriousness of the situation has abated, the operator has been properly relieved by the next shift (or by another licensed operator), collect the specimen in the rest room adjacent to the control room, or defer the test until the next day (without informing the operator in question of any delays).
y i
l eo c- %
Brian Grimes, NRR l
cc:
E. Jordan G. Arlotto l
D. Ross J. Goldberg J. Sniezek l
L. Reyes l
l
l
- to the Minutes of CRGR Meeting No.170 Briefing on Proposed Final Access Authorization Rule September 27, 1989 TOPIC
- B. Morris (RES) and S. Bahadur (RES) briefed CRGR on the status of staff efforts to revise the proposed final Access Authorization rule in accordance with the Committee's review comments at Meeting No. 169.
Briefing slides used by the ' staff to guide their discussion with the Committee at this meeting are enclosed (Attachment 1).
BACKGROUND No additional dccuments were submitted for the Committee's consideration in connection with this status briefing.
The staff will submit a revised package for the proposed rule after completing revisions to reflect CRGR comments at the earlier ueeting.
CONCLUSIONS /RECOP.MENDATIONS There were no recommendations made by the Committee as a result of the discussions with the staff at this briefing.
CRGR will schedule a review of the revised rule package when it is resubmitted by RES.
-?
,g-
--g n
-im=
-..---a mwp,.
-9,w y-g yy-g-e ya rp.w--gam.ye eyege g+-yevas.pr yn--y,+ wf'
RD ISSUES UNDER REVIEW WHY IS A RULE NEEDED IF LICENSE COMMITMENTS ALREADY INCLUDE EQUIVALENT REQUIREMENTS.
JUSTIFICATION FOR PREVIOUSLY PROPOSED EXCEPTIONS TO NUMARC GUIDELINES.
~
- FULL MILITARY HISTORY.
- EXTENSION OF APPEAL RIGHTS TO OTHER THAN PERMANENT UTILITY EMPLOYEES.
- RELIABILITY AND VALIDITY OF PSYCHOLOGICAL TESTS.
- FREQUENCY OF AUDITS, POSSIBLE NEW EXCEPTIONS.
- DEVITALIZATION DURING COLD SHUTDOWN.
- ADDITIONAL CRITERIA FOR GRANDFATHERING. to Enclosure 3
--e.
8 Per Resefor lo clan i LEVELS RE61012.ENtiT6 COST tdo. OF (cMHrtr@,, pe,.
(so,,. sy.oy,t) unmes e.s ce Euh k
. ReA w b.s Ico*
f l
w na:
. s,-n. ss, lnc atmen$s$ $Fpt>ut. So tuowf 2SO k y
j
!g O
~-
b
"?"
h.
2OD
. ML% Q....
1s..'
. c,-d4 cLak......
1es 3
i.
O.9 9 k
.. 7W 4
C NN*
.~
um.au n
- amesma, O
b6F
~g O
lo
=
^'
_ CAM M
=
=
t 5
.ese e i p$y,
t
. wa a.
- /
= 6)$Y x
q iE-O' M61 l$ll M
5 E
~
.P g h s
. w.a owAk
_=
OS
- hhm h--
Date ROUTING AND TRANSMITTAL SUP 5 9</
TO: (Name, o#lce symbol, room number, initials Date buiksing, Agency / Poet)
PDR 3.
4.
5.
i Action Flie Note and Retum Approval For Clearance Per Conversetton ka Roguested For Correction Propero Reph
)
C4rculete For Your Information See Me Comrnent Investigste Signature N
- 2. _ ^u..
Justih REMAnxs l
This previous Central File material can now be l
made publicly available.
i MA71//4t All47ED TO CA/A HEEnA/c Ato.l1D cc
(//S7 OA/l V)
JE44/ Rd71JE
/
PDA
- l. Starry DO NOT use tms form as a RECORD of approvals. concurrences, disposals, clearances and simdar actions FROM: (Name, org. symbo', Agency /Fost) i Room No.-Bldg.
DEMM/S A LL / soy non. No.
2 4t/'/9 5041 102 OPTIONAL FORM 41 (Rev. 7-76)
C IU 1Y1-11.206 P tt 9.c a pe p,
, _. w,
-n
.1 e u. ( (, a-ig
\\
\\'\\
M SEA // TD /DR 06
=
Md7EA/dl #ElafED TO CACA MEE7/UC AlO. l0 70 AE MADE ///84/CL y A//A/24flE l.
MEMO FDA J, IA Y40/l FAO H E. JGRPAU DAND /O -/8-ff St(8/AC7/ M/A/t/rLS 0F CRCA MMEf/MC //VM//A /70
/d/C.LVD/HC r//E FOLLONMC ANctosy,gts t</#XH w/A'r por PAfV/Dt/ sly AltEdsfD:
cl.
AuCLOCUAE
&ii s swexr a siscussioss se s aaesis iou 8e s - ces Eh v A 's o n 96 ness b Da I
NNN 6.
acciosens 8
$v A sexusAy or Discussions sf A Anowsro C,ncJ theen Asbu&on LA e-c.
pseat
~x A syM> af or /Mchsms A /Aonna 2.
MEMO fdA L.t/CAAAN f/OM
, Eh 7 el D47/D h W -$$
FedWJAf/14 AfU//tu M4MAMLS sy J Aft lt^.:AD [fgk S h n e 5 S $<n D Sebl%nSe5 G Qkes hans xMen3 on y DIA% son h h M2Dssur % k mes ssno 9a3-r1
,?//k/////M4 AfV/fto MJ/ZAl///$ ddi il /A6/csso d.
pftMD /5?A E /UA 0#1 p,fflt)
/
fcRw/AD/Ur Alr//w
'ts //./A /ACArts i
f I
- g anou, y
UNITED STATES y'
(
g
' NUCLEAR REGULATORY COMMISSION 5
- j WASHINGTON, D. C. 20555 SEP 2 5 1989 NOTE T0
Jim Conran, CRGR FROM:
Brian Grimes, DRIS, NRR
SUBJECT:
FF0 IMPLEMENTATION NUREG ERRATA I
After the NUREG was forwarded to the CRGR it was noted that the draft document contains the following errors:
The answer.to 10.2 should end with... granted unescorted access.
o The second sentence of the answer to 6.15 should begin with:
This course o
t of action was adopted as...
A few of the referenced discussions need to be renumbered as follows:
o Q/A NO.
REFERENCED NO. CHANGED TO 6.3 6.12 to 6.13 10.6 6.13 to 6.14 10.8 6.8 to 6.9 and 6.13 to 6.14 We are proposing that two new questions and answers be added:
2.7 Must corporate officials who would respond to the E0F or TSC be (new) required to abstain from alcohol at all times or during scheduled work, or does the abstention requirement apply at all when there is no anticipated response to the EOF or TSC?
ANSWER:
The abstention requirements of Section 26.20(a) pertain to working tours within the protected area or at the EOF or TSC.
Corporate officials are not required by the rule to abstain from alcohol simply because they may be called to,the EOF or TSC.
Should they be called in, the procedural requirements of 26.20(e) apply.
Similarly, other licensee employees and contractor and vendor employees (under Section 26.23)'are not required by the rule to abstain from alcohol when not scheduled to work within the protected area or at the EOF or TSC.
[
]-yQMdf.
~
Jim Conran 5.20 If a licensed operator is selected for random testing and the (new) temporary absence from the control room at that time could cause a potential safety problem, what may the licensee do?
ANSWER:
The licensee in this case may wait until the seriousness of the situation has abated, the operator has been properly relieved by the next shift (or by another licensed operator), collect the specimen in the rest room adjacent to the control room, or defer the test until the next day (without informing the operator in question of any j
delays).
Brian Grimes, NRR cc:
E. Jordan G. Arlotto D. Ross J. Goldberg J. Sniezek L. Reyes
f uo u
q[4, a
1 y
UNITED STATES
{
g NUCLEAR REGULATORY COMMISSION g-
- p WASHING TON, D. C. 20555
%, *****/*
September 18, 1989 MEMORANDUM FOR: Edward L. Jordan, Director Office for Analysis and Evaluation of Operational Data FROM:
James H. Sniezek, Deputy Director Office of Nuclear Reactor Regulation
SUBJECT:
CRGR REVIEW 0F RESPONSES TO QUESTIONS ON FITNESS-FOR-DUTY Enclosed is a draft NUREG, " Fitness for Duty in the Nuclear Power Industry:
Responses to implementation Questions." Because of CRGR's continuing interest in fitness-for-duty issues at power reactors, we request CRGR review.
Because of the need for licensees to have this information to develop their fitness-for-duty program policy and implementing procedures, and to complete the training concerning those procedures prior to January 3,1990, we request that CRGR review the draft NUREG as soon as possible.
The responses are to questions asked by licensees and not to hypothetical situations.
The responses reflect current safeguards and inspection staff views on real-world implementation issues.
We believe that the NUREG would be the best means of communicating the NRC staff responses to the licensees.
0GC and OE comments have been incorporated.
We believe that the material enclosed with our request for CRGR review of the proposed fitness-for-duty rule (see memorandum Murley to Jordan, dated March 8, 1988) and the records concerning CRGR meetings 131, 143, and 152 provide appropriate background information.
No new impacts on licensees result from the clarification contained in the draft NUREG; in several cases, the clarification reduces the burden.
please contact Loren Bush at 20944.Should the CRGR need additional information, J4w4 Jame< H. Sniezek, Deputy D rector Of;fi e of Nuclear Reactor Regulation
Enclosure:
Draft NUREG (20 cys) cc: w/ enclosure J. Taylor, E00 0)
,~ f l
.+=r rv v
s
1 2
1p p - m f fkh NUREG-XXXX FITNESS FOR DUTY IN THE NUCLEAR POWER INDUSTRY:
RESPONSES TO IMPLEMEliTATION QUESTIONS Mdnuscript Completed:
Date Published:
Loren L. Bush, Brian K. Grimes Division of Reactor Inspection and Safeguards 0Ffice of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Washington, DC 20555
- r. ~ - ~
Jl 8 ? e n b i
l 2 tlil J j
i ABSTRACT The Nuclear Regulatory Commission published a rule (10 CFR Part 26) concerning fitness for duty of commercial nuclear power plant workers on June 7, 1989, in the Federal Register (54 FR 24468). The rule focuses on methods for control-ling the use of substances that may affect the trustworthiness and performance of workers.
It provides for chemical testing, behavioral observation, employee awareness and education, and employee assistance programs as means for assuring fitness for duty. This report responds to questions concerning the imple-mentation of the rule raised during the Edison Electric Institute's " Fitness-for-Duty Rule Implen,entation Workshop" during July 30-August 2,1989.
It also responds to questions raised by licensees with the staff outside the workshop.
Although the responses constitute reviewed NRC staff positions, publication of this report does not constitute a written interpretatior of the meaning of the rule, as proviced by 10 CFR 26.4.
Only written interpretations hy the General Counsel will be recognized to be binding upon the Commission, i
l 111
i TABLE OF CONTENTS
1.0 INTRODUCTION
1-1 2.0 SCOPE AND IMPLEMEf1TATION OF THE RULE................
2-1 3.0 WRITTEN POLICIES AND PROCEDURES..................
3-1 4.0 TRAINING..'...........................
4-1 5.0 ALC0HOL Af!D DRUG TESTING......................
5-1 6.0 MEDICAL REVIEW OFFICER.......................
6-1 7.0 CONTRACTOR / VENDOR PROGRAF 15..
7-1 8.0 INFREQUENT ACCESS......................... 8-1 9.C ENPLOYEE ASSISTANCE PROGRAM....................
9-1 10.0 MANAGEMEfiT ACTIONS AND SANCTIONS.................
10-1 11.0 REPORTIfiG REQUIREMENTS......................
11-0 1
12.0 M I SC E L L AN E 0 US...........................
12 -1 l
i
1.0 INTRODUCTION
This document responds to questions concerning the implementation of the j
i Fitness-for-Duty Rule (10 CFR Part 26, 54 FR 24468) which were raised:
i During the Edison Electric Institute's " Fitness-for-Duty Rule Implementation Workshop", during July 30-August 2, 1989 During numerous telephone calls, visits and other contacts with the NRC staff by licensee personnel.
Although the responses constitute reviewed NRC staff positions, publication of this report does not constitute a written interpretation of the meaning of the rule _ ' revided by 10 CFR 26.4.
Only written interpretations by the General Counsel will be recognized to be binoing upon the Commission.
l 1-1
2.0 SCOPE AND IMPLEMENTATION OF THE RL'LE 2.1 What is the implementation date?
Answer: The correct implementation date is January 3,1990. The correction was published in the Federal Register on August 11, 1989 (54 FR 33148).
2.2 Nust all provisions of the rule be met by the implementation date?
Answer:
Yes.
2.3 Must personnel who have no responsibilities affecting reactor safety and are not normelly assigned duties under the scope of the rule be covered by I
d licensee's fitness-for-duty program simply because they report to the EOF or TSC? Erergency response personnel who report to the EOF /TSC ana are not required to be b6dged (e.g., clerical or news team), ere they subiect to the ruic: Are licensees requireo to include non-essential EOF personnel (e.g., courier or fax personnel) in ranoom testing?
i 1
Answer:
If individuals are required, by name or position, to physically
- report, i.e., in person, to a licensee's E0F or TSC, the provisions of the rule apply [10 CFR 26.2(a)].
2-1
2.4 If an organization has a contract to provide support personnel, such as guards or clerks to an EOF located off site, and the identities of the indiviauals are not known until actually dispatchen to the E0F, need these individuals be subject to the rule? How about licensee personnel from outside the " nuclear family" where a few people may be selected at the last moment to provide support services at the E0F or TSC?
ANSWER:
No. They have not been identified as an individual by name or position to physically report, i.e., in person, to the E0F.
2.5 Please clarify the requirements applicable to state and local representatives who respond to a licensee's E0F and TSC.
10 CFR 26.2 says-that all persons reporting to a licensee's TSC or EOF are subje;.t to the rule, whereas paragraph 4.2.5 cf the Statment of Considerations (54 FR 24471) states th6t if the E0F or TSC are outside the protected area and the officials do not have responsibilities directly affecting reactor safety, they are not covered by the rule.
Answer:
10 CFR 26.2(e) states that the provisions of the Fitness-for-Duty program nust apply to all persons granted unescorted access to protected areas.
Therefore, the first test for applicability is whether the EOF or TSC are located within a protected area and whether unescorted access is going to be granted to these persons. State and local representatives could be covered under this test.
The next test for applicability is whether the person is a licensee, vendor, or contractor employee required to physically report to the EOF cr TSC.
The state and local 2-2
4 representatives are not included under this test. The discussion contained in paragraph 4.2.5 is intended to further clarify the intent of the rule.
2.6 What about corporate officials who respond to the EOF or TSC but have no responsibilities that could directly affect safety?
Answer:
If these officials are required to physically report to the EOF 4
or TSC in accordance with a licensee's emergency plan and procedures, they must be covered by the Fitness-for-Duty program.
2.7 Must behavioral observation baseline data (such as psychological assessment and supervisory checklists) be implemented for those who don't have access now but will come under the E0F/TSC requirements of 10 CFR 26.2(a)?
Answer: The rule does not require such action.
l 4
2-3 i
3.0 WRITTEN POLICIES AND PROCEDURES 3.1 What is the definition of an " emergency" as used in 26.20(e)(3) with respect to the use of " called-in" individuals who have consumed alcohol l
and whose BAC is above 0.04%.
i Answer:
" Emergency" would need to be determined on a case-by-case basis.
The licensee should consider such factors as the significance of the event and the urgency for the call-in in deciding if an " emergency" exists.
3.2 is an employee subject to the 5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> abstinence requirements
[(26.20(a)(1)] while in an on-call status?
Ar.swer:
Norma ll) "on-call for persons such as duty officers equates to "on-duty," i.e., a working tour within the meaning of 26.20(a)(2).
l l
1 i
3-1 i
4.0 TRAINING 4.1 Must all training be completed by January 3, 19907 Answer:
Yes.
4.2 If certain portions of the training requirements were completed prior to the publication of the rule, need they be repeated?
Answer: Nc.
lhe training requirements are intended to ensure that everyone 6ffected by the program, or responsible for any aspect of its implementation, understands the program and their role in its implementation.
Furthermore, that understanding must be reinforced at least once each 12 months.
Therefore, training or portions thereof need not be repeated prior to Janucry 3,1990, unless more than 12 months have elapsed since the completion of the previous training.
4.3 Pust the training of cor.tr6ctor supervisors be completed within three months of initial assignment on site? What if the supervisor transfers before the three months, will he avoid the training? Is such training transferable between licensees?
Answer:
10 CFR 26.22 requires that all supervisory personnel, including contractors, be trained in supervisory aspects prior to assignment of duties covered by the rule or within three months of initial supervisory assignment, which may have occurred prior to coming on-site. The three-month period does not restart with transfer to another site. Each licensee, prior to granting unescorted access to a contractor supervisor, should assure that the required training has been completed within the schedules specified in 10 CFR 26.22.
A contractor supervisor who has no j
1 supervisory responsibilities while on site (example: planning or estimating a future job) need not be trained under the provisions of 26.22, but must receive training under 26.21.
E J
Licensees may review and accept a contractor's program under 10 CFR 26.23, and may choose to reserve for themselve:, certain portions of the program, such as training. Credit for generic portions of the required training may be transferred from one licensee to another; site-specific training, such as company policy and procedures, are not transferable.
4.4 Should FF0 traininc be included in normal G.E.T. and supervisory training, or shoulc it be a stand alone class?
Answer:
The licensee may choose any option that will result in each person adequately understanding the program and their role in its implementation.
As stated by several attendees at the EEI Workshop, by 4-2
separating the FFD training the subject matter would have greater visibility, students could better focus on the subject, and retention of the knowledge would be enhanced.
l 4.5 Is testing required?
Answer:
Licensees are expected to assure that the training has achieved the desired results. This is usually achieved through testing.
l 4.6 Are there three different types of training required, i.e., employee, supervisor, and escorts?
l Answer:
Yes.
4.7 What would be the difference between supervisor and escort training?
l Answer: Since an escort has only a short-term relationship with the people being escortec, the escort training should emphasize the detection of obvious currerit signs of alcohol or drug use.
In addition to that skill, the supervuer would be 1 coking for long-term patterns, such as attendance and degradation in work performance. The differences are spelled out in 10 CFR 26.22.
4.8 What will satisfy the requirements on training supervisors in drug awareness behavioral observation?
l l
4-3 L-
Answer: Any method that will ensure that the supervisory personnel understand the aspects of their responsibilities as described in 10 CFR 26.22.
4.9 Who is a supervisor? Would it include a person designated as " team leader," " lead person," or " gang boss" for a few days? How about vendor on site for a few hours?
Answer:
The determination of who is a supervisor is up to each licensee.
Such determination should be based upon such factors as who is responsible for the behavioral observation of the person, who is in charge of the l
work, and who is respcnsible for evaluating the performance of the work.
4.10 Who would be responsible for behavioral observation of those persons whose supervisor is not badged and, therefore, not on site? Examples are one or two vendor employees on site for a day or two and INPO personnel.
Answer:
The primary responsibility for behaviorial observation, particularly monitoring long-term trends such as patterns of absenteeisr, always lies with the supervisor of the organiazation to which the individual belongs.
In the case of a few vendor employees on site for a brief period, whoever is responsible for supervising the completion of the work would be responsible for the behaviorel observation of conditions such as intoxication.
In the case of INPO, the team leader should be responsible for the men.bers of his team.
4-4
5.0 ALC0HOL AND DRUG TESTING 5.1 Does NRC's Appendix A preempt the HHS Guidelines?
Answer:
The NRC sees no conflict.
The HHS Guidelines apply to federal agencies and to the testing laboratories. The NRC's Appendix A applies to NRC licensees; the provisions of Appendix A relating to the laboratories should be contained in licensee contracts with the testing laboratories.
5.2 Can a non-certified contract laboratory be used for preliminary screening?
Answer: Although the rule oces not prohibit such a practice, this approach is not preferred.
The approach in question would lose some of the sefeguards tuilt into the rule.
For4gample,morepeoplewillbe hancling a speciroen, a second courier run would be needed, and additional time would be reovired to process the specimens.
In acdition, should there be a legal proceeding, everyone who has handled the specimen in questjun can be summcried to appear. The additional handling could thereby jeopardize the case.
5-1
{
l l
5.3 What should come first in for-cause test situations, referral to EAP for assessment or a test?
Answer: Generally, a test would preceed assessment.
The actions to be taken and their timing would depend upon the situation. For example:
A person that appears to be impaired would normally be physically examined by a physician as soon as possible and then tested.
Enrollment in the EAP would follow.
A person observed while using illegal drugs may need to be tested a few times, each test a few hours after the previous test, to enable the drug (s) or metabolites to reach the urine.
If the drug (s) can be confiscated, they should be tested.
Since 10 CFR 26.27(b)(3) expects in' mediate removal for such acts, referral to the EAP may not apply.
A person involved in an accident described in 26.24(a)(3) or alleged to be using alcohol or drugs should be tested as soon as possible.
)
Referral to an EAP would probably depend on the results of the test.
5.4 Will the NPC have a loose or strict interpretation of after-accident testing?
L-2
Answer: The NRC expects licensee management to exercise prudent judgement as to whether a test is appropriate in each case, using the guidelines contained in the rule.
5.5 Must results of pre-access tests conducted in accordance with 10 CFR 26.24(a)(1) be obtained before unescorted access is granted?
Answer: Yes. A negative test result must be obtained prior to granting unescorted access unless the individual is excluded from the rule by 10 CFR 26.2(a) or previously tested under a program formally reviewed and approved by the licensee under the provisions of 10 CFR 26.23(a).
NRC contractors or state personnel tested under NRC programs do not require pre-access tests by the licensee.
5.6 What constitutes an acceptable approach to selecting persons for random testing? What is not acceptable?
Answer:
10 CFR 26.24(a)(2) permits the licensee to have discretion as to how the random selection is administered and only requires that a person completing a test is immediately eligible for another unannounced test.
The " Medical Review Officer Manual," published by the Department of Health i
and Human-Services suggests that random sampling procedures should permit no " safe periods" for any employee.
"Each work day should present each employee with a new opportunity of having to produce a sample, with the odds equal to all employees on each new day, regardless of samples previously produced by any of them." A common acceptable approach is to 5-?
)
utilize a computer to randomly select a number of persons for testing each l
day. An acceptable approach has been developed by the Southern California i
Edison Company and is referred to by SCE as compound random sampling.
This approach utilizes the statistical phenomena that in a given population being tested at an annual rate of 100%, approximately 67% of the people will be tested at least once during the year, which also means that 33% would not be tested. As time goes on, the population that has not been tested is placed into a separate category where they are randomly selected, separate 6nd apart from those who have been tested. As the people in the untested category are tested, they are placed in the basic pool of people who have been tested and are still being selected at a 67%
probability. Similar approaches were discussed in the Federal Register with the proposed rule at 53 FR 30810.
Any scheme that would contain unfairness in the selection or provides
" safe periods" would not be acceptable. An example would be one that would select people for random testing as they enter the f acility. The l
reason why this wouldn't be acceptable is that nct all persons would have qual probat,ilities of being selected.
For example, some people would enter the facility several times each day with opportunities for selection each time they enter. Other persons might enter the facility only two or i
three times a year; the probabilities of being selected would be quite remote for them. More importantly these infrequent entrants would not be vulnerable to random testing during the period they did not enter the site and, therefore, the deterrent value of random testing would not exist for them.
5-4
5.7 Must collection of a specimen be observed everytime the circumstances constituting reason to believe [as described in Appendix A, Section 2.4(f)] occur, such as when the specific gravity is low or upon return to work af ter rehabilitation? Or, may there be discretion or judgement on the part of the collection personnel as to whether or not they really do have a reason to believe? For example, would be the individual or who is taking a diuretic and consuming considerable quantities of liquids need to be observed?
Answer:
The observation of the collection of a urine specimen is required whenever there is a reason to believe that there may be an attempt to alter or substitute the specimen.
The rule provides examples of what would constitute grounds for reason to believe.
Prudent judgment by the medical staff is expected. The existence of a low specific gravity accompaniec by plausible explanation would not normally cause one to believe there is an attempt to alter or substitute. The prudent course of action is to observe in questicnable cases, and upon return to work aftet rehabilitttion.
5.8 At e witnesste urinanons required during a rehabilitaticr program?
Answer: Direu. oboervation of the collection of specimens during a rehabiliittion program was omitted from the rule, but may be deemed appropriate Ly licensees, either as a matter of policy or on a case basis.
Direct observation is required for the test immediately prior to return
~
to work, but is not required for follow-up testing af ter the er?ployee has been returned to work, unless the medical staff determines that such obsertetion is appropriate.
5-5 l
5.9 Must an immunoassay test be used, as required by Section 2.7(e) of Appendix A, for testing additional drugs added under the provisions of 26.24(c)?
Answer: An immunoassay sh.'
be used wherever appropriate. Should a licensee wish to add a drug to its testing protocol for which there is no immunoassay test, then the licensee should discuss what is the best screening test with its contract laboratory.
5.10 Whenever there is a suspicion that a specimen hdd been adulterated or tamperec, must there be a same gender observer for the witnessed specimen?
Answer:
Ycs, as required by Section 2.4(b) of Appendix A.
1 5.11 A few licensees have expressed an interest in requiring a blood test to confirm the results of breath analysis for alcohol or whenever a urine specimen for drug testing cannot be obtained.
Would the NRC accept such i
proposals?
Answer:
10 CFR 26.24(g) requires that confirmatory tests be cone with a second breath measuren,ent instrument.
The rule further specifies that further confirmation would be an analysis of blood drawn on demand by the individual being tested.
The drawing of blood is judged to be invasive and there are other acceptable approaches.
While the rule does not prohibit accitional blood tests, such action would be without the protection of the rule.
5.12 Can utilities continue their procedure for collecting and testing a second specimen 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the first specimen was confirmed positive; both 5-6
I O
e specimens would have to be tested positive before the results were declared a confirmed positive?
I i
t Answer: No. The practice of using the test results of a second specimen to determine if the results of the first test are indeed confirmed would not be permitted. This procedure, because of the elapsed time between collections, would probably omit most users, except addicts, from detection, i
5.13 Must all results of a batch (of specimens being tested) be reported together as required by Section 2.7(g) of Appendix A, or can negative test results for pre-access tests be reported separately when positive results are pending final determination?
l l
Answer: The test results for all specimens submitted to a certified laboratory at the same time must be reported back to the Medical Review Cf ficer at the same time.
lhis language is also contained in Section l
2.4(g) of the HHS Guidelines and is intended to ensure that acministrative errors in the laboratory are minimized. Negative screening results of l
pre-access tests obteined by licensees prior to submitting presumed l
positive specimens to a certified laboratory may be reported immediately, l
l 5-7 l
l
5.14 A frequent complaint of testing laboratories is that they would lose their HHS certification if, (1) they test for additional drugs; or (2) use lower cut-off levels. Any truth to their claim?
Answer: Subpart C, of the HHS Guidelines indicates that certified laboratories must clearly inform non-federal clients of their procedures.
That requirement indicates that HHS certified laboratories can perform 1
other work outside the scope of their certified work for federal agency.
j programs. This answer has been confirmed as correct by NIDA.
5.15 Does the term "new drug testing program" in Section 2.8(e)(2) apply to laboratories which were under contract to the licensee before the rule?
Answer:
Yes.
Licensees are expected to provide blind performance test specimens to assure that the laboratory work is accurate.
If such blind specimens were submittea in the quantities anc time periods specified, covered the drugs and cut-off levels used after implementation of the rule, and the laboratory was certified by HHS during that time, then the licensee can take crealt for' completing the inital 90-day period of this quality assurance proceaure.
(See related discussion at item 10.5.6 of NUREG-1354, " Fitness for Duty in the Nuclear Power Industry: Responses to Public Comments).
5.16 Are there reasonable limits concerning who are the specimen couriers that l
must meet the honesty and integrity standards of Section 2.3 in the NRC Guidelines? Would the standards apply to contract couriers who may change j
5-8
daily? How about Postal Service employees, Federal Express couriers, and pilots and crews of aircraft?
Answer:
The intent of the rule is to prevent the integrity of the testing program from being subverted. The more remote the possibility of a personal relationship existing between the person whose specimen is being processed for testing and any person doing the processing, the less likely that deliberate acts to subvert the integrity of the test would occur.
Therefore, the licensee should have reasonable assurance that couriers employed to pick up and deliver specimens meet normal expectations of honesty and integrity.
Licensees could assure themselves that a contract courier service takes reasonable precautions, such as bonding of employees (based on some oppropriate standard other than payment of a fee).
Postal Service employees are not covered by the rule.
5.17 Why must alcohol breath analysis equipment meet state standards, as required by Section 2.7(o)(3)?
Answer Since the states have been developing and enforcing statutes for dealing with drunk drivirg, the inclusion of the " applicable state statutes
- provision for testing equipment in the rule should result in a more credible test result.
5-9
5.18 What vendors can provide spiked samples?
Answer: For information, licensees should contact the National Institute onDrugAbuseat(301)443-6780. Sources that have been suggested by NIDA include:
Research Triangle Institute 3040 Cornwall Road Research Triangle, North Carolina 27709
Contact:
Ken Davis j
1 (919)541-6709 i
4 DU0 - Research, Inc.
164 Conduit Street Annapolis, Ma ryl6nd 21401-2513 Contect: Dr. Robert Willette (301) 263-5749 Bio - RAD Labordtory 3700 East Miralcrra Ave.
Annaheim, California 92800
Contact:
Robyn Hawkins or Elizabeth Chardon (800)854-6737 Hycor Medical Garden Grove, California
Contact:
Petricia Pick (714)546-9EC1 5-10
l.
Biometric Laboratories l
10100 Santa Fe, Suite 301 Overland Park, Kansas 66202
Contact:
Terry Oakleas (913)341-3222 5.19 Can licensees use specimens that have been tested negative for the 80%
blank blind performance test samples that must be submitted under the provisionsofSection2.8(e)(3)?
ANSWER: The blank specinren must be certified to contain no drug.
Specimens must not be used if they contain drugs below the cut-of f levels, or any drugs that could cross-react and mimic the drugs for which the test is being concucted. The propriety of a laboratory providing its clients with blind sarples to test its proficiency could be questioned.
i 5-11
6.0 MEDICAL REVIEW 0FFICER 6.1 Can a physician's assistant function as the Medical Review Officer (MR0)?
Ansu r:
No. Section 2.9(b) of the NRC Guidelines requires that the Medical Review Officer be a licensed physician with knowledge of substance abuse disorders. This language is also contained in the HHS Guidelines.
A physician's assistant would not be able to perform as Medical Review Officer unless the physician's assistant was a licensed physician ana had knowledge of substance abuse disorders.
6.2 Under the appeals permitted under Section 26.28, who is qualified to review the Medical Review Officer's determination?
gsv:er:
The rule permits an impartial internal management review.
This could be an individual or a board of impartial managers.
6.3 When does the 10-day clock begin for the Medical Review Officer when on-site prescreening is used? What if the Medical Review Officer cannot contact the individual within the 10-day period?
_ Answer: Section 2.4(e) requires that the MR0 review be completed and licensee management notified within 10 days of the initial presumptive positive screening test. The 10-day reporting requirement would not be 6-1
l i
applicable if the person is not working within the protected area and is not available for interview by the Medical Review Officer. The NRC expects that reasonable efforts to contact the individual at his or her residence would be taken.
In such a case, any interviews and the MR0's determination should be completed as soon after the individual is available as is possible (see related discussion at 6.12). Of course, any-individual who is impaired or whose fitness may be questionable must be removed from unescorted access status under the provisions of 10 CFR 26.27 (b)(1).
If the sample is. lost, the report to licensee management would be based on available information.
6.4 Who may the results of initial screening tests be shared with?
Answer: Section 26.24(d) states that the access to the results of a preliminary test must be limited to the licensee testing staff, the Medical Review Officer, the Fitness-for-Duty program manager, and the Employees Assistance Program staff, when appropriate. The results of the initial screening test at the certified laboratory may be provided to the MRO only af ter confirmatory tests and laboratory reviews have been completed [Section2.7(g)]. Negative results of initial screening tests and MR0 determined negatives anc confirmed positives may be provided to management.
Negative results of pre-access tests may be provided immediately,
6.5 If a group of persons are being processed to be hired, can management be informed of negative results of pre-employment screening tests if anyone 6-2
-m
-. -.e-mag t-t w
1 in the group of applicants are' presumptive positive? What if the tests are pre-access, random or follow-up?
Answer:
10 CFR Part'26 does not cover pre-employment testing by a licensee. Negative results of pre-access and follow-up tests may be reported immediately.
Results of' random-tests must await completion of laboratory tests and MRO evaluation.
4 6.6 May negative test results from the HHS certified lab be provided direct'ly to the fitness-for-Duty Program Administrator?
l
\\
l Answer: Section 2.7(g) of the NRC Guidelines requires that the test results be reported to the licensee's Medical Review Officer. This 1
language is also contained in'the HHS Guidelines and is intended to i
protect the identity of those who may have tested positive but not yet j
been determineo as positive by the MRO..
6.7 We plan to have several MR0s under contract. May test results from the l
HHS-certified laboratory be forwarded through the Fitness-for-Duty Program Administrator?
Answer:
In view of the MR0's responsibilities to advise and assist managment in the planning and oversight of the FFD progran (see discussion at 6.8), this is not a preferred option. However, should a 6-3
licensee choose this option, the proposed administrative routing through the Program Administrator to the MR0 would be acceptable, provided the test results are protected and not disclosed to the Program Administrator until the MR0's review has been completed.
6.8 Must the medical review officer review both positive and negative test results?
Answer:
No. Although the primary responsibility of the Medical Review Officer is to review and interpret positive test results obtained through the testing program [Section 2.9(b)], the Medical Review Officer does have a role in reviewing the performance of the licensee's screening facility and the HHS-certified laboratory and advising and assisting managment in the planning and oversight of the tverall substance abuse program as described in the " Medical Review Officer Manual."
In conjunction with these broad responsibilities, the MP0 has the discretion to review negative test results if provided for in the licensee's program, particularly those that fall just short of the cut-off levels, to determine if there is a problem that neecs to be addresseo either with the employee or with the program itself.
6.9 Can the Medical Review Officer initiate any action if results are below the cut-off levels? That is, can the f1R0 recommend the suspension of an employee basea upon an unconfirmed positive?
6-4 l
l
Answer:
The Medical Review Officer can take appropriate action based upon his judgement.
However, that would be done without the protection of the rule.
Based upon the circumstances, the MR0 may refer the individual to the Employee Assistance Program for review and counseling.
If the i
individual, based on evidence other than the test, is determined to constitute a hazard to himself or herself or to others, the individual may be referred-to licensee managment under the provisions of 26.25 and 26.27(b)(1).
t 6.10 At what point is a test considered a confirmed positive?
l Answer: When the Medical Review Officer has made a final determination-that the results have been confirmed as positive. This would occur _after he has reviewed the laboratory report, provided the individual an opportunity to discuss the test results, and completed 6ny other matters thet he deemed appropriate before the determination is made.
This does not preclude the Medical Review Officer from making an early determination based upon other information.
On the other hand, if there is a logical or legitimate explanation provided early on for the drug or drug metabolite being in the individual's urine specimen, then the Medical Review Officer can determine that the test results are negative.
6.11 Does the requirement to examine clinical evidence mean that there must be a face-to-face encounter between the Medical Review Officer and the employee whose laboratory results indicate positive? Can a Medical Review Officer be located some considerable distance from the site?
6-5 i
Answer:
The question relates to the requirement stated in Section 2.9(d) in the NRC Guidelines, which requires that the Medical Review Officer l
determine whether there is clinical evidence of opiate abuse.
To meet this requirement, the Medical Review Officer would need to look for needle.
tracks, or-behavioral and psychological signs of acute opiate intoxication or withdrawal.
A detailed-explanation of this process is described in the Medical Review Officer Manual. Obviously, such a requirement could only be j
accomplished with a face-to-face examination by the Medical Review Officer.
In some cases, the MRO could discuss the test results by telephone with the individual, provided suitable precautions are taken.to confirm identity and protest the information as required by 10 CFR 26.29(a) j and(b).
6.12 Can a Medical Review Officer be someone from the testing laboratory?
Answer:
Using someone from the testing laboratory to serve as the Medical Review Of ficer would probably be a conflict of interest because the Medical Review Officer is expected to make judgements concerning the performance of the labcrbtory, request that the laboratory repeat tests that he might qt,estion the scientific ddequacy and 50 f orth.
Therefore, using a person from the testing laboratory as the Medical Review Officer would be contrary to the intent of both the NRC and the HHS Guidelines.
6.13 Does the Medical Review Officer have to discuss the test results with the individual prior to determining that the results are positive?
E-6
Answer: No. Section 2.9(c) of the NRC Guidelines require that the Medical Review Officer shall give the individual an opportunity to discuss the test results.
If the individual is not available, any interviews should be completed as soon after the individual is available as is possible (see related discussion at 6.3).
6.14 Since an Medical Review Officer will give the individual an opportunity to discuss the test results prior to making his final' decision under the provisions of 2.9(c), can management also be notified at that time so that the individual's access can be. suspended?
Answer: Section 2.9(c) of the NRC Guidelines requires that licensee management not be notified of positive test results until the Medical Review Of ficer has determineo that the laboratory test result has been verified as a confirmed positive.
This language is also contained in Section 2.8(c) of the HHS Guidelines.
There was a lengthy discussion on this issue at the EEI workshop. A number of the attendees strongly expressed their opinion that they should remove an individual from safety-related responsibilities at the first indication that the individual has a substance abuse problem. There were also several comments that psychoactive drugs, such as PCF and LSD, have no legitimate medical use and there is a high potential for unpredictable psychosis and agitation, therefore, any person using those drugs clearly constitutes a serious potential hazard to safety; such persons should be promptly removed irrespective of what the NRC and the HHS Guidelines state.
These remarks have been repeated several times in other forms to the NRC staff.
6-7
The Comission's decision to require that management not have access to unconfirmed test results was based upon establishing the proper balance between individual rights and the interests of public safety. That issue was addressed by the Department of Health and Human Services in the responses the public comments to the HHS Guidelines (53 FR 11974).
In that Federal Register Notice, HHS suggested that the agency " develop a mechanism to expedite the review process or_ allow the Medical Review Officer to require a review of the individual's general fitness to continue performing a specific function.".The response by HHS goes on to say that, " circumventing the review system would abridge necessary protections for employees and could result in prejudging an individual employee's case." See related discussions at 6.4, 10.6, 10.8, and 10.9.
6.15 If an employee is arrested in possession of drugs', our personnel policies dictate that the individual would be terminated immediately, without -
waiting for a conviction.
On the other hand, if we have a presumptive positive test for drugs, then we would have to wait several days maybe a week or longer until that information is confirmed before we can take action.
We regarc that as a glaring inconsistency and we shoula not have to live with it.
P Answer:
The rule expects that the Medical Review Officer make a determination as to whether or not the results are positive and that there be no action taken tu jeopardize the individual's employment until the 6-8
determination is made.
The decision to adopt this course of action as a prudent balance between individual rights and interest of public safety.
The NRC makes no connection between the results of the urine test and current impairment, and assumes there are some undetected users.
The issue is the trustworthiness and the reliability of the employee.
In the case where the employee has been arrested, the licensee should look into the matter, assure that the facts are as reported, and then take action in accordance with personnel policies which should cover that kind of event.
Of course, a licensee or contractor employee exhibiting signs of impairment should immediately be removed from unescorted access status, irrespective of the status of testing.
6.16 Are the requirements of 2.7(g)(4) and (5) in conflict? Section 2.7(g)(4) permits the laboratory to transmit results to the Medical Review Officer by various electronic means as long as the confidentiality of the information is protected.
Section 2.7(g)(5) says that the laboratory shall forward the original chain-of-custody form attached to which shall be a copy of the test report.
Answer:
The NRC regaras these as separate but compatible requirements.
Section 2.7(g)(5) can be satisfied after g(4) has been accomplished.
Section 2.7 (g)(4) would provide the licensee with a rapid means of obtaining the information, and Section 2.7(g)(5) is the procedure for the official formal notification and contains evidence that would need to be retained for any legal proceeding.
6-9
6.17 Does the Medical Review Officer personally have to see the chain-of-custody form?
Answer: Yes.
Section 2.7(g)(5) requires that the laboratory send the original chain-of-custody form to the Medical Review Officer. The Medical Review Officer, in determining that any test result is positive, should assure himself that all relevant evidence bearing on that case is obtained and protected so that proper disposition of the case through any legal proceeding is possible. However, a determination that a confirmed positive test has been made can be based on electronic transmittal of the test information.
6.18 If the Medical Review Officer decides to respond to an individual's request to have a specimen retestec, does the specimen have to be tested by a different laboratory?
Answer:
No.
Section 2.7(g) of the NRC Guidelines permits re-analysis at the same leboratory cr at an alternete laboratory, as determined by the tiedical Review Of ficer.
f.19 If you split a sample, do you have to use a different laboratory?
Answer: Section 2.7(j) requires, that the split sample, at the tested individual's request, be forwarded to another HHS-certified laboratory that did not test the aliquot (the original half of the specimen).
On the other hana, if the MR0 deternines that the test result is scientifically insufficient, the MR0 may [under the provisions of lection 2.9(g)] request reanalysis of the original sample.
In that case the I:R0 has the cption of requesting reanalysis by the original laboratory or having a second leboratory anelyze an aliquot.
6-10
7.0 CONTRACTOR / VEND 0R PROGRAMS 7.1 What requirements must be met so that there can be reciprocity among licensees with respect to contractors and vendors?
An:wer: Each licensee accepting a particular contractor or vendor program must review and approve the contractor / vendor program under the provisions of 10 CFR 26.23(a).
Licensees may accept any initial or periodic audit of the effective implementation of such program by another licensee under the provisions of 10 CFR 26.80.
7.2 Can licensees accept other programs, such as those administered by other licensees, state ano local governments and the Department of Energy under the provisions of 10 CFR 26.23? What if the other program does not include alcohol testing?
Answer:
Licensees may review and approve any program thet neets the overall intent of 10 CFR Part 26 and includes, as a minimum, employee awareness training and chemical testing, including random testing. A program that does not include alcohol testing would not meet the intent of the rule, and would not be acceptable on its own.
7.3 Car, a licensee accept perts of a contractor or vendor program? For example, can a licensee collect specimens for testing of contractor 7-1
- ~_
employees under a contractor's program reviewed and approved by the 3
licensee under the provisions of 26.237 Answer: Yes.
The licensee can substitute, supplement, or duplicate any portion of a program that it deems appropriate for achieving the goals of 1
the rule. For example, pre-access and random testing _ for alcohol and drugs could be conducted by licensees and the other portions of contractor, state and local or DOE programs could be accomplished through the reviewed and approved program.
7.4 Do contractors, even small ones such as grass cutters and building cleaners, have to have an EAP7
_ Answer: Only if the _ licensee has reviewed and accepted the contractor's program under the provisions of 26.23.
If the licensee does not accept the contractor's program, or the contractor does not have a program (which is probably the usual situation with a small contractor), the contractor will come under the licensee's fitness-for-duty program. Where the contractor is being covered by the licensee's program, the licensee is not required to provide the cor. tractor with an Employee Assistence Program.
7.5 If a person, who is under the care of a contractor's EAP, is sent to a licensee's site, how 1.s that care continued and how is the patient's progress reported back _to his employer to ensure that the person is continuing the treatrient and receiving the counseling that is appropriate?
7-2
Answer: That is a matter is left to the discretion of each licensee.
It would be appropriate for those kinds of situations to be addressed through a provision of the contract.
The contractor has an obligation under t
26.23(a)(2) to notify the licensee of such a situation and the licensee must determine that the particular circumstances are acceptable. There are three obvious courses of action: (i) tell the contractor employee that he may not work at the site, (ii) the contractor must find some kind of an EAP service that is available locally, or (iii) agree to provide Employee Assistance Program services to support the contractor's program.
7.6 How many licensees will not permit any contractors to return to the plant after the first positive test?
Answer: A survey. of the audience was conducted.
There was an overwhelming affirmative response to the question.
With one or two exceptions, contractors would be barred from the plant as a result of the first positive test.
7.7 A contractor's program was revieweo and approved by a licensee. Must both the licensee and the centractor audit the contractor's program?
Answer:
Yes.
10 CFR 26.80 requires each licensee to audit its program and those poeticns of programs implemented by contractors and vendors.
For a contractor or vendor program to be acceptable under the provisions of 10 CFR 26.23, the contractor or venour program must meet all aspects of the rule, therefore the contractor or vendor must audit its own program.
7-3
o i
8.0 INFREQUENT ACCESS l
8.1 Is pre-access testing required each time a contractor or vendor employee starts working at a site?
Answer:
If the contractor / vendor has a program that has been reviewed and accepted by more than one licensee under the provisions of 26.23, then any l
employees of the contractor / vendor may transfer between such licensee's i
facilities without having to repeat the pre-access test, provided that'all i
provisions of the rule have otherwise been met.
For example, a pre-access test was administered prior to the initial granting of unescortec access l
at the first facility and the errployee was continuously covered by both a l
behavioral observation program and a random testing program while he worked for and transferred between the two licensees.
(A reasonably short period of time to accomplish the transfer need not be included.)
Contractor errployees not covered by a program reviewed and approved by a licensee under the provisions of 10 CFR 26.23 should be pre-access tested.
Any pre-access or random test conducted under a program covered by the rule, completed within 60 days prior to assignment to activities covered by part 26 at the previous site will satisfy 26.24(a)(1).
[
8-1
...,.,.n.-,
8.2' May licensees accept another licensee's fitness-for-duty program under a
" reciprocity agreement" for persons who may need to visit another site?
Answer: Yes.
The " visitor" must be continuously covered.by the behavioral observation and random testing provisions of either or both of the licensee programs.
(Seerelateddiscussionsat7.1,7.2,and8.1) 8.3 What testing and access procedures are acceptable for utility personnel, such as maintenance personnel, who_may need unescorted access to the nuclear facility, but are normally dispersed throughout the licensee's system and may not be working in a location where they can be' tested? Can the licensee suspend their access between on-site assignments pending pre-access testing on each return to the site without other administrative requirements, such as inquiries, training, etc?
l Answer: The licensee has discretion as to how it wishes to administer the program in the case in question. The basic options are: (1) to retain the personnel in the fitness-for-duty pregram which means that they be subjected to refresher trainire, random testing, etc., or (ii) to remove them f rom the prograr and ensure that they have been tested within 60 days prior to each tirr.e they are returned to the program (this option would also require that the employee be subject to all provisions of the rule as a "new" employee, including training, upon their return). For individuals in remote locations who are retained in the FFD program, the licensee has the option of having these people report to a temporary collection site or having them return tc a permanently established collection site.
6-2 i
i
8.4 Is a contractor employee subject to pre-access screening at different sites, if the last screening was within 60 days?
Answer:
No. Any pre-access or random test administered within the previous 60 days under a program meeting the requirements of Part 26 would meet the requirement. Also, if the contractor has a fitness-for-duty program reviewed and accepted under the provisions of 10 CFR 26.23 by each of the affected licensees, the pre-access screening would apply only upon initial access under a program covered by the rule.
8.5 heed suitable inquiries be conducted for (i) those who are not under a fitness-for-duty progran for an extended period; (ii) contractors who are er, site once per year, and (iii) persons granted unescorted access to any nuclear site during the past year?
Answer:
Such inquiries need not be conducted if the centractor employee is continuously covered by a fitness-for-duty program in conformance with the rule.
l I
1 l
l C-5
1 l
9.0 EMPLOYEE ASSISTANCE PROGRAM 9.1 What constitutes an effective fitness-for-Duty program? How do you measure an Employee Assistance Program?
Answer:
The Commission has tasked the NRC staff to closely monitor the implementation of the rule and revisit the need for changes within 18 months following the implementation date.
What constitutes an effective program, and what are appropriate program performance indicators are being consioered as part of that effort.
Industry may wish to explore methods of measuring an EAP, which is not part of the NRC staff effort.
9.2 Pust licensee management and the NRC be notified when a person self refers to the EAP and hos drugs or alcohol in his system?
i Answer:
Licensee managercent would not be notified unless the medical personnel determineo thet the person constituted a hazard to himself or to others. As for reporteL111ty to the NRC, self-referrals are not reportable under Section 26.73. hUMARC die not included such inforroction on their data collection f orm, however, the NRC may collect EAP program performance data during inspections.
(See answer to 9.6.)
9.3 Does the requirement for supervisory procedures to initiate appropriate corrective action [10 CFR 26.22(a)(5)] include referral for voluntary assistance?
l i
I 9-1 i
~
Answer: No. Once a supervisor has confronted a troubled employee and referred the individual for assessment, the protections afforded an employee who self-refers should not be provided to the individual referred by the supervisor.
9.4 What follow-up is required for employees who self referred on a substance use problem?
Answer: The nature, character and frequency of the followup should be determined by the doctor who is treating the patient.
9.5 What is a safety hazard f or purposes of reporting EAP self-referrals to management?
Answer:
That would be up to the judgerrent of the person evaluating the patier,t, with general knowledge of nuclear power plant work demands, normally based on discussior;s with licensee management.
9.6 How rouch documertition on EAPs should be available for NRC inspections?
Answer:
That matter is under study. At this point, the NRC would be interested in data concerning program utilization and measures for protecting confidentiolity.
9-2
10.0 MANAGEMENT ACTIONS AND SANCTIONS 10.1 For those employees who have tested positive before the rule was j
published, will their records be wiped clean on January 3,1990 or will a past test failure count under the rule?
Answer: After January 3,1990, the next positive test would be considered the first positive test under the provisions of the rule. The NRC would certainly expect the licensees to take action in accordance with the provisions of the rule, and the rule permits licensees to take more stringent actior. than specified in Section 26.27. Therefore, there is sufficier.t flexibility in the rule so that the vast majority of licensees who indicated during the work-shop that they would consider past test results as if they were under the rule would be able to do so.
- However, such actions would not be required.
10.2 Please clarify the term "sultable inquiries" that are conducted over the previous 3-unc 5-year time periods?
Answer:
The question relates to the definitior, of suitable inquiries which requires that licensees must, on a best effort basis, determine whether or not that there is a history of alcohol or drug problems over the previous 5 years, but no case less than 3.
Licensees must make a 10-)
best effort.to obtain the information. Should the information not be obtainable, then licensees must consider whether or not they should bring the person on board. There are situations where licensees may not be able to get any information, particularly in cases where applicants are coming from a foreign country.
In those cases, the licensees would have to determine what is appropriate and document their efforts to obtain the information.
In all cases, licensees must make a best effort to determine 4
whether the person is reliable and trustworthy and can be granted an escorted access.
10.3 When a " suitable inquiry" is maoe to a licensee, what information should be disclosea?
Answer: Section 26.27(a) requires that the licensee determine if the applicant has ever been (i) tested posit'ive for drugs or ever. used alcohol resulting in on-duty impairment, (ii) treated for substance abuse except for self referral, (iii) removed because of a fitness-for-duty problem, and(iv) der,ieaunescortedaccess.
Obviously, to respond to such an inquiry, licensees should have o records system which contains that kind of information (see 10 CFR 26.29 and 26.71).
10.4 What if the licensee's legal department determines that disclosure of such information violates their state law?
Answer:
The Statement of Considerations, Section 18.2.3 at 54 FR 24489 states that Federal law, i.e., the Atomic Energy Act and codified rules 10-2
issued under its authority, preempts state laws with regards to all matters pertaining to radiological safety of the operation of nuclear power reactors. Where the Fitness-for-Duty Rule imposes a requirement on the licensee related to safe operation of the reactor, the Fitness-for-Duty rule preempts any conflicting state law.
10.5 How should licensees deal with persons who have had a confirmed positive test result at another plant that uses cutoff levels different than employed at your f acility? For example, licensee "A" uses a standard of 100 nanograms and licensee "B" uses a standard of 20 nanograms per milliliter for the initial screening test for marijuana, with respective confirmatory cutoff levels of 20 and 4 nanograms, respectively.
Answer:
Under the previsions of 10 CFF. 26.71(b), a confirmec positive test result (without the levels detected) is a transferable record to be provided in response to a suitable inquiry mace under the provisions of 10 CFR 26.27(u).
Furthernore, the suitable inquiry to deternire if the persor rac "testec pcsitive for drugs" would be limited to test results receivec ano determined as a confirmec positive by the Medical Review Officer.
The f act that a person has useo crugs is not altered by use of a l
different cutoff level; the ability to detect drug use is affected.
10.6 If e person can be removed for cause from the workplace, cannot a preliminary screening result, in combination with observation of unusual behavior, allow management to take action before a test result is confirmed by an NR0 deternination?
10-0
)
Answer: The unusual behavior should constitute sufficient basis for j
temporary suspension of unescorted access and the conduct of a for-cause test.
10 CFR 26.24(d) and Sections 2.7(g) and 2.9(c) prohibit management from having access to presumptive positive preliminary screening or initial screening results. See related discussion at 6.13, 10.8, and 10.9.
I 10.7 What is acceptable, management and medical assurance of satisfactory rehabilitation?
)
Answer:
That is up to each licensee to determine. As advances in the state-of-the-art occur, several approaches may become available.
]
l Cu'rrently, licensees could set up a program to have these people
]
l periccically examined on an unannounced basis. Licensees also could employ a radioimmonassay test of hair that consists of taking a few strands of hair, usually from the scalp. Since hair grows about one cm per montn, the strands can be cut into lengths corresponding to specific periods of anterest.
For example, if a six centimeter sample is obtained it could be cut into 6 one-centimeter sections, each representing approxinately one month of druc use history.
The test results of several successive segments esteblishes the pattern of drug use during the period in question.
10.8 If a preliminary screening test shows drug use, what cen management know and do?
10-4
Answer:
" Management" may not be informed of r.ny test result not reviewed and confirmed as positive by the Medical Review Officer, as required by 10 CFR 26.24(d) and Sections 2.7(g) and 2.9(c) of Appendix A.
It follows that management may take no action, unless EAP personnel notify management that the individual's condition may be a hazard to himself or others (seeSection26.25).
See related discussions at 6.4, 6.5, 6.8, and 6.13.
10.9 If management is informed of the results of a preliminary test, what enforcement action will the NRC take?
Answer:
Negative screening results of pre-access tests obtained by licensees prior tc submitting presumptive positive specimens to a certi-j filed laboratory tray be reported to management.
(Seeenswer5.13.)
Informing management of a presumptive positive screening result would constitute a violation of 10 CFR 26.24(d), and Sections 2.7(g) and 2.9(c) 07 Appendix A to Part 26. The severity of the violation would be dependent on the actions taken by management in response to the preliminary informaticn.
To ensure thet the integrity of the program 15 n;aintainec and indivicual rights properly safeguarded, the NRC believes that mamagerer.t actior should be based on corrplete infornation.
Therefore, except for the safety implications provided for in Section 26.25, management actions based on preliminary positive results may be a significant violation.
10.10 What reasonable actions should be taken with known off-duty drug or alcohol abuse? For incidents that result in arrest?
10-5
Answer:
That is up to each licensee to determine. Actions similar to what the licensee would take had the event occurred on site could be considered.
The rule did not cover such situations because it is believed that current licensee personnel policies address matters such as criminal acts off tho job.
10.11 Does' an of f-site drug arrest count as one bite of the apple?
Answer:
NRC assumes that existing personnel policies deal.with criminal acts, particularly felony convictions.
If someone is retained, NRC would expect appropriate counseling and action. Should a subsequent drug related incident occur, it would be prudent to remove the person from i
unescorted access. Such information should be passed on in response to a suitable inquiry,
?
10.12 Since management must be notifieo, is a self referral to EAP considered a first test failure?
Answer: No. Since managenent is not normally notified if a person
(
seif-referrec to the EAP, a positive test resulting from an initial i
assessment would not be considered a first test failure on the employee's l
personnel or medical records. Any determination of subsequent drug use l
while uncer treatment would be considered a positive test result reportable to management.
10-6
10.13 What action should be taken if the alcohol test results are under 0.04% BAC, especially with those tests that are taken later in the shift that would make you suspect that either the person came into work drunk or was drinking on the job?
i 1
Answer:
Each licensee should decide what actions are appropriate.
l If the time elapsed since start of work indicates tht the individual's BAC was above 0.04% while on duty, the licensee should take appropriate action.
i 10.14 What are ef fective deterrences for alcohol abuse if a licensee has a different policy for alcohol than for drugs?
Answer:
Section 26.27(b)(5) requires that sanctions for confirmed misuse of alcohol be suf ficiert to deter aause of legally obtainable substances as e substitute for abuse of proscribed drugs.
What constitutes a sufficient deterrert is for each licensee to determine.
10.15 Wnet sanctions are approricte for prescription and over-the-counter drugs?
Answer:
The licensee has discretion as to what action should be ta ken.
10-7 i
. - ~
10.16 What are acceptable sanctions for alcohol abuse and refusal to be tested?
Answer: These sanctions are at the discretion of the licensee.
The NRC would expect that a' person refusing to be tested, at a mimimum, would not be granted unescorted access to the protected areas.
10.17 Who will take the lead in the development of a list of approved or risky over-the-counter and prescription drugs?
i Answer:
This apparently will be left to the licensees since neither NUMARC nor eel indicated during the workshop that they would take the leed in the development of such a list.. This issue was discussed in some aetail in Chapter 3 of NUREG/CR-5227, Supplement 1.
10-8
11.0 REPORTING REQUIREf1ENTS 1
11.1 What are the reporting requirements concerning persons above 0.04%
BAC when called in and when on-call?
1 Answe_r:
Section 26.73 requires only that the licensee report such an event involving licensed operators or supervisory personnel determined to be unfit for scheduled work due to the the consumption of alcohol.
Therefore, if a licensed operator or supervisor is called in, the assumption is that he was not scheduled for work, and no report is required.
If the licensee's policy considers "on-call" as constituting scheduled work, then such persons being above 0.04% BAC would be reportable.
Furthermore, the NF.C would expect licensees to exercise prudent judgement on whether or not unusual situations should be reported as a significant fitness-for-cuty event under the tredning of 10 CFR 26.73(a).
Note: Significant fitness-for-cuty events are not limited to the examples centained in 26.73(a)(1) anc (2).
11.2 If a licensee tests other drugs or uses lower cut-off levels, what are the reperting requirements?
Answer:
The NRC would expect that if someone has violated the licensee's Fitness-for-Duty Program, that it be reported in l
l 11-1 l
l l
I l
accordance with 10 CFR 26.73 when applicable, and included in the program performance data submitted to the Commission in accordance with 10 CFR 26.71(d).
This includes oather drugs and experiences with lower cut-off levels. To meet the requirement in 26.71(d) to include the results of tests using lower cut-off levels, the data should be provided so that the number of people identified at lower cut-off levels can be compared to the number that would have been identified at the cut-off levels i
established in the rule.
11.3 If you call an employee who is not scheduled for work or formally "on call" ano the individual says he or she has been drinking and tests 0.04%
BAC or highter, is this reportable to the NRC?
Answer:
l'u.
11.4 What are the reporting requirements if a person on-call is tested positive for alcohol?
l l
Answer:
10 CFR 26.73 requires reporting of acts by licensed opuators or any supervisory personnel involving the use of alcchol withn the protected area or resulting in unfitness for scheduled work.
Therefore, l
if the person is not a licensed operator or supervios no report is required. Likewise, if the work is not scheduled, no report is required.
"On-call" is generally considered "on-duty."
Licensee judgement should be used to determine the appropriateness of reporting fitness matters beyond the minimum reporting requirements.
For example, l
j a site manager whose EAC is less than 0.04%, but has alcohol on his breath 11-2
.s.
9 may be the cause of a news medial report and therefore come to the attention of the f4RC and the public.
l 11.5 If a licensed operator is denied access, is it reportable immediately as it is today, or under the time-frame in the rule?
Answer: Since the effective date of the rule is July 7,1989, the licensees may now choose to report such an event under the provisions of 26.73.
1 11.6 Must the tiRC be notified on fitness-for-duty violations involving f
contractor / supervisory personnel?
Answe_r:
Yes. A report should be made urder the provisions of 26.73(a)(2) irrespective of whether the violation was under a licensee's progrem or under a contractor's program approved under the provisions of 10 CFR 26.23. Licensees necd not report data which has been reported by another licensee.
11.7 Should a fincin; cr cicohol or drugs withiri the protected area (no person in possession) be reported?
If so, under 73.71 or 26.737 Answer:
Yes.
Possession would be inferred and would be requried to be reported as a significant fitness-for-duty event under the meaning of 10 CFR26.73(a).
1;cte :
Significant fitness-for-duty events are not limited to the exartples contairied in 26.73(a)(1) and (2).
11-3
,=.
11.8 Should the attempted introduction of alcohol or drugs into a protected area be reported? What if the person is a visitor?
Answer:
That would depend upon the circumstances. Should the individual be a licensea operator or supervisor, a report should be made to the NRC; a summary entry in the semi-annual report for most other instances would be appropriate.
11.9 On the NUMARC data collection sheet, do all contractors do their own data reporting, or does the utility consolidate?
Answer: There is no requirement for a contractor to seno the data to the NRC. The requirement is placed on the licensee. The NUMARC data ccllection form has room for reporting Juch data. The licensee, iri his contract, should require that such information be provided.
How this is accomplished is left to each licensee.
11.1: Could the licensee ask the contractors to submit the date collection form to the licensee?
Answer:
Yes. The licensees could require the contractor to do that.
Licensees need not report contractor data which has been reported by another licensee.
11-4
.,u 12.0 MISCELLANE0US l
12.1 What is meant by " nominal," as used in 26.21(b), 26.22(b), and 26.80(a).
Is it a one-month slack? Can it be plus or minus three months?
j Answer:
" Nominal is meant _to provide reasonable lattitude. Plus or minus l
l one month would be reasonable.
Plus or minus three months would be consistent with the 25 percent maximum allowable extension of a specified interval a:, described in Specification 4.0.2 of the Standard Technicti Specifications.
This would be acceptable provided it is not used re-peatedly as an operational convenience to extend the training interval beyond that specified.
12.2 Will there be a new SALP functional area for Fitness-for-Duty?
Answer:
Current hF,C policy permits the Regions to acc tcpics to the SALP as they may ceem necessary.
There is currently no initiative to add Fitness-for-Duty as a new SALP functional area. The current guidance includes Fitness-for-Duty as one of several activities under the security functicnal area.
12.3 Can licensees accept HHS audits of the certified testing labratories?
Answg: No.
HHS audits are limited to those aspects of laboratory programs certified for Federal agency testing programs.
12-1
j l
I 12.4 Can licensees accept contractor audits of HHS-certified laboratories if the contractor has a program reviewed and approved by the licensee?
l Answer:
Yes.
12.5 Can licensee "A" accept licensee "B" audit of a testing laboratory if licensee "B" doesn't require as stringent cut-off levels or test for additional drugs?
l Answer:
Licensee A may accept those portions of licensee B's audit of program elements that have standards that are used by both licensees.
l Both licensees would need tu oudit those program elements that do not use similar stancards.
l I
12.6 Does the requirement to prove that a removed individual has remainea drug-free for three years constitute handicap discrimination under the Rehabilitatier, Act, as amended in 1978.
Answer:
At this tinie, the Congress of the United States is considering legisit tion to enlarge the employment rights of disabled persons.
12.7 Some licensees have truck drivers, tug boat operators, and other employees that must be covered under both Department of Transportation and NRC l
rules. Where the rules conflict, particularly if a licensee wishes to use.
lower cut-off levels, test for additional drugs, or use split samples, what rule nust be met?
Ar.swer:
Licensees rust collect separate specimens for testing under each progren.
12-2
.