[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