ML20247Q208
| ML20247Q208 | |
| Person / Time | |
|---|---|
| Issue date: | 07/25/1989 |
| From: | Carr K NRC COMMISSION (OCM) |
| To: | Lisa Sullivan HEALTH & HUMAN SERVICES, DEPT. OF |
| Shared Package | |
| ML20245E824 | List: |
| References | |
| FRN-54FR24468, RULE-PR-2, RULE-PR-26 AC81-2-042, AC81-2-42, NUDOCS 8908070073 | |
| Download: ML20247Q208 (5) | |
Text
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! yg NUCLEARWASHINGTON, REGULATORY COMMISSION DRIS i/f D. C. 20555 JScinto g /,g VStelIo
, # JTaylor t,% * # July 25, 1989 HThompson
- TMurley CHAIRMAN JSniezek FMiraglia l j BRGimes
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The Honorable Louis Sullivan Secretary of Health and Human Services r$n LBUsh Washington, D.C. 20201 RDopp 3
Dear Mr. Secretary:
ED0 r/f l JBlaha l The Nuclear Regulatory Comission (NRC) recently published a final rule requiring our licensees to implement fitness-for-duty' programs. The intent of the rule is to ensure that nuclear power plant personnel are not under the influence of any substance, legal or illegal, or mentally or physically 1 impaired from any cause that could in any way adversely affect their ability to safely and competently perform their duties. During development of the rule, l the Commission decided that the minimum standards for drug abuse and drug testing in the commercial nuclear power industry should be consistent with i
those for Federal programs developed in accordance with Executive Order No. )
12564, dated September 15, 1986, and Section 503 of Public Law 100-71. How- l ever, based on the experience of our licensees, the Commission is concerned i that the cutoff levels for marijuana and amphetamines should be lower and that i barbiturates and benzodiazepines should be added to the panel for drugs for )
which testing would be administered. l Therefore, the Commission requests the expert advice of the Department of Health and Human Services (HHS) on the merits of including additional drugs and lowering the cutoff levels for certain drugs in an amended NRC Fitness-For-Duty Programs Rule. The specific cutoff levels that we are proposing are listed in Enclosure 1, and our specific reconinendations for additions to the mandatory panel of drugs are contained in Enclosure 2.
Comments on the rule from the regulated industry were overwhelmingly in favor of lower cutoff levels for marijuana. Information provided to the NRC indi-cates that approximately two-thirds of our licensees have established cutoff levels for the initial screening tests for marijuana lower than 100 ng/ml.
Seventy-three percent of all the positives reported by the industry were between 50 and 100 ng/ml. Two licensees who were using a cttoff of 20 ng/ml were able to provide extensive data showing that 80 percent of their presump-tive positive tests were between 20 and 100 ng/ml. While concerns have been expressed that lower cutoff levels may result in more false positive tests, we understand that no false positives were reported nor claimed as a defense in p3 I. . , any case using a 20 ng/ml cutoff level for marijuana. Based oa this data and the additional infonnation provided in Enclosure 3, we believe that a change in i t n E the cutoff levels is warranted.
Ru' g}b outu industry comments on the rule also supported the addition of barbiturates and j P}l q
$$y benzodiazepines to the required test panel. Information provided to us indi- //
g cates that over 60 percent of our licensees are testing, or plan to test, for kIZ 8@
gug these drugs. Additional information supporting our consideration of adding these drugs to the test panel in an amended NRC rule is contained in Enclosure 4, yj gi[/
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Should HHS advice be supportive of an amended NRC rule, I also request HHS to consider revising the " Mandatory Guidelines for Federal Workplace Drug Testing Programs." The Commission believes that a revised guideline incorporating i these changes and applicable to all Federal programs may strengthen the i Government's efforts to ensure a drug-free Federal workplace and allow NRC to '
apply uniform fitness-for-duty standards and testing requirements to our licensees and employees.
You should also be informed that the NRC, in finalizing its rule, made pro- ;
cedural modifications to further protect individual rights. The appendix to the NRC rule specifies measures to prevent subversion of the testing process, permits the splitting of specimens, requires that confirmation testing for .
opiates include a test for six monacety1 morphine (MAM), specifies protection of I records, and establishes procedures for appealing positive determinations.
To assist you in reviewing our proposal, I have enclosed a copy of NRC's final l Fitness-For-Duty Programs Rule (Enclosure 5) and the NRC publications relating to the development of the final rule (Enclosures 6-8). We would appreciate your comments as early as possible on amending the NRC rule. .NRC licensees are required to meet NRC's Fitness-For-Duty Programs Rule by January 3, 1990.
If a rule amendment is deemed necessary, it would be useful to issue the .
amendirent before our licensees have fully implemented their programs in l accordance with our rule. We would appreciate your views on revising the
" Mandatory Guidelines for Federal Workplace Drug Testing Programs" within a reasonable time.
Sincerely, l
Kenneth M. Carr
Enclosures:
- 1. List of Specific Cut-Off Levels Requested
- 2. List of Aricitional Drugs Re ammended
- 3. Discussion Paper: Amphetamines and 1 Marijuana Cutoff Levels
- 4. Discussion Paper: Barbiturate and Benzodiazepine Urinalysis l 5. Final Rule: 10 CFR Parts 2 and 26
" Fitness-For-Duty Programs" (54 FR 24468)
- 6. NUREG-1354, " Fitness For Duty in the Nuclear Power Industry:
A Review of Technical Issues"
- 7. NUREG/CR-5227, " Fitness For Duty in the Nuclear Power Industry:
Responses to Public Commer.ts"
- 8. NUREG/CR-5227, Supplement 1
" Fitness For Duty in the Nuclear Power Industry: A Review of Technical Issues" l
)
q [ q ru y k Should HHS advice be supportive of an amended NRC rule. I also request HHS to j
consider revising the " Mandatory Guidelines for Federal Workplace Drug Testing l
fYograms. " The Commission believes that a revised. guideline incorporating these changes and applicable to all Federal programs may strengthen the Government's efforts to ensure a drug-free Federal workplace and allow'NRC to apply unifom fitness-for-duty standards and testing requirements to our licensees and employees.
You should also be informed that the NRC, in finalizing its rule, made pro-cedural modifications to further protect individual rights. The appendix to the NRC rule specifies measures to prevent subversion of the testing process, permits the splitting of specimens,. requires that confirmation testing for opiates include a test for six monacetylmorphine (MAM), specifies protection of records, and establishes procedures for appealing positive determinations.
To assist you in reviewing our proposal, I have enclosed a copy of NRC's final Fitness-For-Duty Programs Rule (Enclosure 5) and the NRC publications relating to the development of the final rule (Enclosures 6-8). We would appreciate your comments as early as possible on amending the NRC rule. NRC licensees are required to meet NRC's Fitness-For-Duty Programs Rule by January 3, 1990.
If a rule amendment is deemed necessary, it would be useful to issue the amendment before our licensees have fully implemented'their programs in accordance with our rule. We would appreciate your views on revising the
" Mandatory Guidelines for Federal Workplace Drug Testing Programs" within a reasonable time.
Sin:erely, originalsigned%:
l Kennem M. Can Kenneth M. Carr i
Enclosures:
l 1. List of Specific Cut-Off Levels l Requested
.. List of Additional Drugs Recomended 3 Discussion Paper: Amphetamines and Marijuana Cutoff Levels Originating Office:
o, Discussion Paper: Barbiturate and ED0/NRR Benzodiazepine Urinalys b Ref: CR-89-096 S. Final Rule: 10 CFR Partt. 2 and 26 (CommissionCorrespondence)
" Fitness-For-Duty Programs" (54 FR 24468)
- 6. NUREG-1354, " Fitness For Duty i
in'the Nuclear Power Industry:
1 A Review of Technical Issues"
- 7. NUREG/CR-5227, " Fitness For Duty in the Nuclear Power Industry:
Responses to Public Comments" _
y,,4 .....8. NURES/CR-5227, Supplement 1
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a List of Specific Cut-Off Levels Requested Proposed Initial Test Cutoff Levels
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Specific drug or metabolite Cutoff level -
Drug for which test is conducted in ng/ml Marijuana Delta-9-tetrahydrocannabinol 50 )
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Amphetamine Amphetamine 300 I Proposed Confirmatory Test Cutoff Levels Specific drug or metabolite Cutoff level Drug or drug class for which test is conducted in ng/ml Marijuana Delta-9-tetrahydrocannabinol 10 Amphetamine Amphetamine 300 Methamphetamine 300 l
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Enclosure 1
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1 List of Additional Drugs Recommended l l
Proposed Initial Test Cutoff Levels Specific drug or metabolite Cutoff lcrel l Drug class for which test is conducted in ng/ml 1 Barbit. urate Secobarbital 300 Benzodiazepines Conjugated Oxazapam 300 Proposed Confinnatory Test Cutoff Levels Specific drug or metabolite Cutoff level Drug class for which test is conducted in ng/ml Barbiturate Secobarbital 300 Thiopental 300 Amobarbital 300 Pentobarbital 300 Secobarbital 300 Aprobarbital 300 i
Hexobarbital 300 Benzodiazepines* 0xazapam 150 Desmethyldiazepam 150 Alprazolam 150 a-hydroxyalprazolam 150 3-HM 150 a-hydroxytriazolam 150 Conjugated drugs and metabolites.
Enclosure 2
,