[Federal Register Volume 60, Number 221 (Thursday, November 16, 1995)]
[Notices]
[Pages 57587-57589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28273]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration


Changes to the Testing Cutoff Levels for Opiates for Federal 
Workplace Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration, PHS, 
HHS.

ACTION: Notice of proposed revisions.

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SUMMARY: The Department of Health and Human Services (HHS) is proposing 
to revise the Mandatory Guidelines for Federal Workplace Drug Testing 
Programs, 59 FR 29916 (June 9, 1994). 

[[Page 57588]]
Specifically, the Department is proposing to change the drug testing 
levels currently used to test for opiate metabolites in urine specimens 
collected as part of the Federal Workplace Drug Testing Program and to 
require the testing for a metabolite of heroin. The goals of the 
proposed new opiate testing policy are to substantially reduce the 
number of laboratory opiate positives that Medical Review Officers 
ultimately verify as negative, shift the emphasis of opiate testing 
back to the proper focus to deter and detect heroin use, and reduce any 
unnecessary/excessive costs to drug testing without compromising the 
original drug deterrent objectives.

DATES: Comments on these proposed revisions to the Mandatory Guidelines 
are invited and must be submitted by January 16, 1996.

ADDRESSES: Written comments should be addressed to Joseph H. Autry III, 
M.D., Director, Division of Workplace Programs, SAMHSA, Room 13A-54, 
5600 Fishers Lane, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT:
Dr. Donna M. Bush, Chief, Drug Testing Section, Division of Workplace 
Programs, SAMHSA/CSAP, Room 13A-54, 5600 Fishers Lane, Rockville, 
Maryland 20857, tel. (301) 443-6014.

SUPPLEMENTARY INFORMATION: The Department proposes increasing the 
initial and confirmatory testing cutoff levels for morphine and codeine 
from 300 ng/mL to 2,000 ng/mL and establishing a new requirement to 
test for 6-acetylmorphine (6-AM), a metabolite that comes only from 
heroin, using a 10 ng/mL confirmatory level for specimens that have 
tested positive on the initial test. When the Federal Workplace Drug 
Testing Program was established, HHS adopted the same 300 ng/mL testing 
levels for opiates that were used by the Department of Defense for 
testing service members. These levels were selected in an attempt to 
provide the greatest opportunity to identify anyone who may have used 
heroin; however, at the 300 ng/mL level, many who have not used heroin 
but had taken a prescribed codeine or morphine medication or eaten 
normal dietary amounts of poppy seeds have also tested positive. Since 
the purpose of the drug testing program is to deter or detect 
individuals using illicit drugs, establishing the testing cutoff levels 
for opiates at the proposed 2,000 ng/mL and adding the requirement to 
detect 6-AM will eliminate the identification of most persons 
legitimately using opiate-containing pharmaceuticals available by 
medical prescription or in over-the-counter preparations, or those who 
have ingested poppy seeds. The Department of Defense adopted similar 
increases in the testing cutoff levels for opiates effective April 1, 
1994, because of similar concerns and its program experience over the 
last 5 years. Changing the levels for the Federal Workplace Drug 
Testing Program will have similar direct effect as evidenced by the 
results obtained from several Medical Review Officers and laboratories 
regarding the large number of laboratory positives that were verified 
negative by MROs. In addition, the results indicate that specimens 
screened positive at or above the proposed 2,000 ng/mL testing cutoff 
levels for opiates are the specimens most likely to contain 6-
acetylmorphine, a metabolite of heroin.
    The Department has evaluated results on over 1.1 million urine 
specimens tested for opiates in 5 certified laboratories and 
approximately 317,500 specimens that were reviewed by 3 different 
Medical Review Officer (MRO) groups. Each laboratory and MRO group was 
asked to furnish information on results reported from January 1, 1992, 
to March 31, 1993. Based on the information obtained from the MROs, 87% 
of all opiate positives reported by the laboratories were verified 
negative by the MRO based on the use of prescription medications, poppy 
seed consumption, no clinical evidence of heroin use, or other reason. 
It is clear that the current opiate testing cutoff levels are not 
properly identifying opiate drug abusers.
    The results from the laboratories indicate that of the approximate 
1.1 million specimens tested, 7294 specimens were reported positive for 
codeine and/or morphine. Of these positive specimens, 5931 had codeine 
and/or morphine concentrations less than 2,000 ng/mL. Within the group 
of 7294 opiate positives, 848 were also tested for 6-acetylmorphine (6-
AM) with only 16 of these 848 being reported positive for 6-AM. 
Additionally, 14 of these 16 6-AM positives had morphine concentrations 
greater than 2,000 ng/mL.
    When comparing information from other published studies, there was 
agreement that the presence of 6-AM is highly associated with morphine 
concentrations in excess of 2,000 ng/mL.
    In light of these results, the Department is proposing to increase 
the initial test level for opiate metabolites to 2,000 ng/mL and the 
confirmatory test levels for morphine and codeine to 2,000 ng/mL. In 
addition, the Department is proposing to establish a requirement to 
test for 6-AM in specimens positive for opiates on the initial test 
using a 10 ng/mL confirmatory test level. 6-AM is a metabolite of 
heroin and no other medication or substance is known to produce it; 
therefore, its presence is positive proof of heroin use. Since 6-AM has 
a very short half-life (i.e., detectable for only a few hours after 
heroin use), it is essential that a laboratory use a sensitive 
analytical procedure to test for 6-AM. From the data available, it 
appears that 10 ng/mL is the lowest testing level that can reasonably 
be used to consistently and accurately identify and quantitate the 
presence of 6-AM. Additionally, the 10 ng/mL confirmatory test level 
for 6-AM is currently used by many laboratories that test for 6-AM 
after an MRO submits a request. The Department believes the proposed 
requirement to test for 6-AM will not increase the workload for a 
laboratory because setting the initial test level for opiate 
metabolites at 2,000 ng/mL will significantly reduce the number of 
specimens that will need to be confirmed for morphine, codeine, and 6-
AM.
    The Department believes that raising the testing levels for opiates 
and establishing a requirement to test for 6-AM does not reduce the 
deterrent value of the Federal Workplace Drug Testing Program, but 
rather shifts the emphasis of opiate testing back to the original focus 
to deter and detect use of illicit drugs, including heroin. A change in 
the testing cutoff levels, in conjunction with the addition of 6-AM 
testing, should provide more than adequate protection that heroin users 
will be detected. The cost to Federal agencies may be reduced since 
there will be fewer specimens screened positive hence, a reduction in 
the number of specimens sent to confirmatory testing. The laboratories 
will be reporting fewer opiate positives which will also reduce the 
time and cost for MROs to discuss use of legitimately obtained opiate 
containing preparations with individuals who have been tested positive 
by the laboratory.
    The SAMHSA Drug Testing Advisory Board has discussed these results 
and has recommended adopting the new opiate testing cutoff levels 
described above.

INFORMATION COLLECTION REQUIREMENTS: There are no new paperwork 
requirements subject to the Office of Management and Budget approval 
under the Paperwork Reduction Act of 1980.


[[Page 57589]]

    Dated: September 26, 1995.
Philip R. Lee,
Assistant Secretary for Health.

    Dated: November 6, 1995.
Donna E. Shalala,
Secretary.

    The following amendments are proposed to the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs published on June 9, 1994 
(59 FR 29916):

Subpart B

    1. Section 2.4(e)(1) is amended by changing the initial test level 
for opiate metabolites appearing in the table from ``300'' to ``2,000'' 
and deleting footnote 1.
    2. Section 2.4(f)(1) is amended by changing the confirmatory test 
levels for morphine and codeine appearing in the table from ``300'' to 
``2,000.''
    3. Section 2.4(f)(1) is amended by adding in the table under 
opiates a confirmatory test level for 6-Acetylmorphine at ``10 ng/mL.''

[FR Doc. 95-28273 Filed 11-13-95; 8:45 am]
BILLING CODE 4160-20-M