[Federal Register Volume 62, Number 189 (Tuesday, September 30, 1997)]
[Notices]
[Pages 51118-51120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25823]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Mandatory Guidelines for Federal Workplace Drug Testing Programs
AGENCY: Substance Abuse and Mental Health Services Administration, HHS
ACTION: Revisions to the Mandatory Guidelines
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SUMMARY: On November 16, 1995, the Department of Health and Human
Services (HHS) published a notice in the Federal Register at 60 FR
57587 proposing to revise the Mandatory Guidelines for Federal
Workplace Drug Testing Programs, 59 FR 29916 (June 9, 1994).
Specifically, the Department proposed to change the drug testing levels
for opiate metabolites and to require the testing for a metabolite of
heroin in urine specimens collected as part of the Federal Workplace
Drug Testing Program. After considering the comments, this Department
is revising the Mandatory Guidelines to add such requirements. The
goals of the revised new opiate testing policy are to substantially
reduce the total number of specimens laboratories report positive for
opiates that Medical Review Officers verify as negative, to shift the
emphasis of testing for opiates back to the proper deterrence and
detection of heroin use, and to reduce any unnecessary/excessive costs
to drug testing without compromising the original drug deterrent
objectives.
EFFECTIVE DATE: May 1, 1998.
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: After considering comments received from the
public, the Department is revising the guidelines entitled ``Mandatory
Guidelines for Federal Workplace Drug Testing Program,'' (Mandatory
Guidelines) which were initially published in the Federal Register on
April 11, 1988 (53 FR 11979) and revised on June 9, 1994 (59 FR 29908).
This revision and the Mandatory Guidelines are developed in accordance
with Executive Order 12564 dated September 15, 1986, and section 503 of
Public Law 100-71, 5 U.S.C. section 7301 note, the Supplemental
Appropriations Act for fiscal year 1987 dated July 11, 1987. This
revision incorporates changes based on the comments received during the
public comment period and the Department's experience in implementing
and administering these Mandatory Guidelines.
Background and Summary of Public Comments
A. Proposed Changes to the Testing Cutoff Levels for Opiates
The changes proposed in the notice published in the Federal
Register on November 16, 1995, 60 FR 57587, are summarized here to
facilitate the discussion of the comments received during the public
comment period.
The Department proposed increasing the initial testing cutoff level
for opiate metabolites and the 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.
The Department evaluated results on 1.1 million urine specimens
tested for opiates in five certified laboratories and 317,500 specimens
that were reviewed by three Medical Review Officer (MRO) groups. Based
on the information obtained from the MROs, 87% of all opiate positives
reported by the laboratories were verified as negatives by the MROs.
The reasons given for reporting negative results included the use of
prescription medications, poppy seed consumption, no clinical evidence
of heroin use, or other unspecified reason. The reversal of most opiate
positive results clearly indicates that the current opiate testing
cutoff levels used by the laboratories are identifying too many
individuals who are not opiate abusers. The 300 ng/mL testing levels
had been selected to provide the greatest opportunity to identify
anyone who may have used heroin. However, many who have not used heroin
but had taken a prescribed codeine or morphine medication or eaten
poppy seeds (which may contain morphine and/or codeine) have also
tested positive. Since the purpose of the workplace drug testing
program is to deter and detect use of illegal drugs, establishing the
testing cutoff levels for opiates at these higher levels will eliminate
the identification of most individuals who are legitimately taking
prescription medications that contain morphine or codeine or have
ingested poppy seeds.
With regard to testing for 6-AM, the laboratory results indicate
that of the approximately 1.1 million specimens tested, 7294 specimens
were reported positive for codeine and/or morphine. Within this group
of 7294 opiate positives, 848 were also tested for 6-AM and 16 of these
848 were reported positive for 6-AM. Of particular interest, was that
14 of these 16 6-AM positives had morphine concentrations greater than
2,000 ng/mL. In light of these results, the Department proposed to
establish a requirement to test for 6-AM in specimens positive for
opiates on the initial test because of the increased probability of
detecting 6-AM when the morphine concentration was greater than 2000
ng/mL. 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 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.
The Department believes that raising the testing levels for opiates
and establishing a requirement to test for 6-AM will not reduce the
deterrent value of the Federal Workplace Drug Testing Program.
Additionally, the cost to Federal agencies may be reduced since there
will be fewer specimens screened positive for opiates, fewer specimens
sent to confirmatory testing, and fewer opiate positive results
requiring extensive MRO review.
B. Public Comments and the Department's Response
The Department received 22 public comments on the proposed changes
to the testing levels for opiates from individuals, companies, and
laboratories. More than 50% of the commenters supported all or part of
the proposed changes, while five commenters disagreed with the entire
proposal. The remaining commenters expressed concern only with the
implementation of a new policy and did not provide any comments to
either support or disagree with the proposed changes. All written
comments were reviewed and taken into consideration in setting the new
testing levels. The substantive concerns raised in the
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public comments and the Department's responses to the comments are
discussed below. Similar comments are considered together.
1. Raising the Initial Testing Cutoff Level
More than 50% of the commenters supported raising the initial
testing level for opiates as proposed. They agreed that the current
initial testing level was unnecessarily identifying a large number of
specimens as positive for opiates that were verified negative by the
Medical Review Officer (MRO). Five commenters, however, were opposed to
raising the initial testing level because it would no longer identify a
number of individuals that misuse prescription medications that contain
morphine or codeine. The Department recognizes that a very small
percentage of individuals who abuse opiates that are currently reported
positive using the 300 ng/mL initial test level would no longer be
reported positive. However, the Department believes that the benefits
from not reporting a large number of positives that are verified as
negatives by an MRO outweigh the small risk of not detecting misuse of
prescription drugs.
One commenter opposed deleting the footnote that had established an
initial testing level of 25 ng/mL for free morphine and suggested a new
level be established by applying the same factor that was used for the
proposed opiate testing level. The Department disagrees with this
comment. Since heroin, codeine, and morphine are excreted as varying
concentrations of unchanged drug, glucuronide conjugates, and other
metabolites, the Department believes it is more appropriate to use
initial test kits that have a cross-reactivity with these metabolites
rather than using a test kit that only detects free morphine. Because
of this cross-reactivity, the Department believes it is appropriate to
continue to list the initial test level as ``opiate metabolites''
rather than as morphine.
One commenter agreed that the initial test level should be raised,
but suggested that the Department specify the analyte to be used for
the test kit calibrators, that is, either morphine, morphine-3-
glucuronide, or codeine. The Department agrees that the specific
analyte used to calibrate a test kit has a direct impact on its ability
to detect the presence of a drug or metabolite in a urine specimen.
Therefore, test kit manufacturers should continue using morphine to
prepare the calibrators for the revised opiate test kits as they had
been using for the current opiate test kits.
2. Raise the Confirmatory Test Levels for Morphine and Codeine
The majority of the commenters agreed that raising the confirmatory
test levels for morphine and codeine was appropriate and that the
levels should correspond to the level established for the initial test.
However, two commenters suggested that the confirmatory test level for
morphine be raised to 4,000 ng/mL to make the test level consistent
with that established by the Department of Defense (DoD) for its
testing program. The Department does not agree that the two programs
must use the same confirmatory testing levels. In light of the
information found in the study of 1.1 million specimens noted above,
the Department believes that the 2,000 ng/mL is the cutoff level that
should be used at this time for agency testing.
3. Establish a Confirmatory Test Level for 6-Acetylmorphine
A majority of the commenters supported establishing a confirmatory
test level for 6-acetylmorphine (6-AM); however, there was disagreement
that it should be tested for on each specimen that was positive on the
initial test. There were suggestions that a laboratory only test for 6-
AM when the morphine concentration exceeds 2,000 or 4,000 ng/mL, or
when the MRO requests a 6-AM analysis. Several commenters stated that
testing for 6-AM on all presumptive positives places an unnecessary
burden on the laboratory to conduct a second separate confirmatory test
which will increase the cost of testing. In addition, there were
suggestions that presumptive positives be tested only for 6-AM since
the focus of the opiate testing is to identify heroin use. The
Department believes that since the number of presumptive positives
going to confirmation testing at a 2,000 ng/mL initial test level will
be reduced significantly, there will not be a significant increase in
the cost associated with testing for 6-AM. However, we do agree that
testing for 6-AM on each presumptive positive may be unnecessary. Based
on the pharmacology of heroin metabolism, 6-AM is likely present only
when morphine is present in the specimen and its concentration exceeds
2,000 ng/mL. The concentration of codeine has no bearing on the
possible presence of 6-AM. Therefore, the Department agrees with the
commenters that 6-AM should only be tested for after a laboratory
confirms that the morphine concentration exceeds 2,000 ng/mL rather
than testing for 6-AM on each specimen that was positive on the initial
test as had been proposed. In other words, a positive codeine without
morphine present or with morphine less than 2,000 ng/mL will not
automatically require a test for 6-AM. The final revisions to the
Mandatory Guidelines have been changed accordingly.
4. Implementation
Several commenters expressed concern that the new testing levels
could not be implemented immediately because the test kit manufacturers
will need sufficient time to reformulate their kits and to get them
cleared by the Food and Drug Administration (FDA). Additionally, the
laboratories will need time to validate new confirmatory test
procedures using the new testing levels. The Department agrees that a
sufficient time must be allowed for the new levels to be implemented
and, therefore, the effective date is 180 days from the date of this
publication.
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.
Dated: April 18, 1997.
Nelba Chavez,
Administrator, Substance Abuse and Mental Health Services
Administration.
Dated: June 11, 1997.
Donna E. Shalala,
Secretary.
The following amendments are made 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), the initial test level for opiate metabolites
appearing in the table, is amended by changing the value of ``300'' to
``2,000'' and deleting the footnote that had specified a 25 ng/mL
testing level if the immunoassay test was specific for free morphine.
2. Section 2.4(f)(1), the confirmatory test level for morphine
appearing in the table, is amended by changing the value of ``300'' to
``2,000.''
3. Section 2.4(f)(1), the confirmatory test level for codeine
appearing in the table, is amended by changing the value of ``300'' to
``2,000.''
4. Section 2.4(f)(1), the table of confirmatory test levels, is
amended by adding a new line under opiates to read as follows:
6-Acetylmorphine \4\ 10 ng/mL
\4\ Test for 6-AM when the morphine concentration exceeds 2,000
ng/mL.
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5. Section 2.4(f)(1), the table of confirmatory test levels, is
amended by
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adding a new footnote under the table to read as follows:
[FR Doc. 97-25823 Filed 9-29-97; 8:45 am]
BILLING CODE 4160-20-U