[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