Mandatory Guidelines for Federal Workplace Drug Testing Programs

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