[Federal Register Volume 63, Number 227 (Wednesday, November 25, 1998)]
[Rules and Regulations]
[Pages 65128-65129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31495]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket No. OST-98-4777]
RIN 2105-AC74


Amendments to Opiate Threshold Levels

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

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SUMMARY: This final rule makes conforming changes to the Department's 
drug testing procedures to incorporate changes made by the Department 
of Health and Human Services (DHHS) in the threshold levels of opiates. 
It is essential for the Department's drug testing procedures to remain 
consistent with the DHHS Guidelines, as Congress provided in the 
Omnibus Transportation Employee Testing Act of 1991.

EFFECTIVE DATE: The final rule takes effect on December 1, 1998.

FOR FURTHER INFORMATION CONTACT: Robert C. Ashby, Deputy Assistant 
General Counsel for Regulation and Enforcement, Room 10424, (202-366-
9306); 400 7th Street, SW., Washington, DC 20590 or Mary Bernstein, 
Director, Office of Drug and Alcohol Policy and Compliance, Room 5405, 
(202-366-3784); 400 7th Street, SW., Washington, DC 20590.

SUPPLEMENTARY INFORMATION: On September 30, 1997, the Department of 
Health and Human Services (DHHS) published the final amendments to its 
Mandatory Guidelines for Federal Workplace Testing Programs (DHHS 
Guidelines) and indicated that May 1, 1998 would be the effective date 
for implementing these amendments. The amendments raised the initial 
and confirmatory test opiate thresholds from 300 nanograms per 
milliliter (ng/ml) to 2000 ng/ml. The DHHS amendments also established 
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 for morphine on the confirmatory 
test at the 2000 ng/ml level.
    DHHS made changes to the testing cutoff levels for opiates 
following a notice and opportunity for comment. DHHS received 22 
comments, of which a majority favored their proposal. Under the 
previous standards, 87 percent of laboratory positive opiate specimens 
were verified as negative by medical review officers (MROs). DHHS 
anticipates that these amendments will eliminate the identification of 
most individuals legitimately taking prescriptions including morphine 
or codeine or who have ingested poppy seeds.
    Subsequent to the publication of the final amendments, it became 
clear that manufacturers would not be able to provide a sufficient 
supply of the modified opiate test kits by the May 1, 1998 effective 
date. On February 4, 1998, DHHS sent a letter to all Federal agencies, 
HHS certified and applicant drug testing laboratories, and immunoassay 
kit manufacturers informing them that the effective date would be 
delayed 4 to 6 months beyond the May 1, 1998 effective date.
    DHHS chose December 1, 1998 as the new effective date for 
implementing the new opiate testing cutoff levels. DHHS was satisfied 
that manufacturers of test kits can provide an adequate supply of the 
modified opiate test kits to the laboratories by the December 1, 1998 
effective date and that the laboratories would be able to use these 
opiate test kits to conduct the initial and confirmatory tests at the 
revised testing levels for opiates.
    It is essential for the Department's drug testing procedures to 
remain consistent with the DHHS Guidelines, as Congress provided in the 
Omnibus Transportation Employee Testing Act of 1991. Consistency is 
also necessary to avoid confusion in the testing process. For these 
reasons, the Department is making conforming changes to its drug 
testing procedures in 49 CFR Part 40.

Regulatory Process Matters

    The final rule is considered to be a nonsignificant rulemaking 
under the DOT Regulatory Policies and Procedures. It is also a 
nonsignificant rule for purposes of Executive Order 12886. The 
Department certifies, under the Regulatory Flexibility Act, that the 
final rule does not have a significant economic effect on a substantial 
number of small entities. The rule does not impose any costs or burdens 
on regulated entities, since it will result in

[[Page 65129]]

fewer opiate positives having to be reviewed by medical review 
officers. The rule has also been analyzed in accordance with the 
principles and criteria contained in Executive Order 12612, and it has 
been determined that it does not have sufficient federalism 
implications to warrant the preparation of a Federalism Assessment.

Issuance of Final Rule Without Opportunity for Notice and Comment

    With respect to the amendments to 49 CFR Part 40 concerning opiate 
testing levels, the Department has determined that it would be 
impracticable, unnecessary, or contrary to the public interest to 
provide an opportunity for notice and comment under 5 U.S.C. 553(b). 
These amendments are conforming amendments making the Department's drug 
testing procedures consistent with those of DHHS, as is required under 
the Omnibus Transportation Employee Testing Act of 1991. Before 
publishing its amendments to the DHHS Guidelines, DHHS solicited, 
received, and responded to public comment on the identical provisions. 
Since there has already been an opportunity for public comment on the 
substance of the changes and consistency is necessary to avoid 
confusion in the testing process, the Secretary finds good cause under 
5 U.S.C. 553(d)(3) for the final rule to be effective less than 30 days 
from the date of publication in the Federal Register.

Paperwork Reduction Act

    This rule contains no new information collection requirements under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq).

Unfunded Mandates Reform Act of 1995

    The Department has determined that the requirements of Title II of 
the Unfunded Mandates Reform Act of 1995 do not apply to this 
rulemaking.

Office of the Secretary of Transportation

List of Subjects in 49 CFR Part 40

    Drug testing, Reporting and recordkeeping requirements, Safety, 
Transportation.

    For the reasons set forth in the preamble, the Office of the 
Secretary amends 49 CFR Part 40 as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

    1. The authority citation for Part 40 continues to read as follows:

    Authority: 49 U.S.C. 102, 301, 322; 49 U.S.C. App. 1301 nt., 
app. 1434 nt., app. 2717., app. 1618a.


Sec. 40.29  [Amended]

    2. In section 40.29(e)(1), the initial test level for opiates 
appearing in the table is amended by revising the value ``300'' to 
``2000'' and deleting the footnote ``*'' that had specified a 25        
ng/ml testing level if the immunoassay test was specific for free 
morphine.
    3. In section 40.29(f)(1), the confirmatory test level for morphine 
appearing in the table is amended by revising the value from ``300'' to 
``2000''.
    4. In section 40.29(f)(1), the confirmatory test level for codeine 
appearing in the table is amended by revising the value from ``300'' to 
``2000''.
    5. In section 40.29(f)(1), the table is amended by adding a new 
line under opiates to read as follows:


Sec. 40.29  Laboratory analysis procedures.

------------------------------------------------------------------------
                                               Confirmatory test cutoff
                                                    levels (ng/ml)
------------------------------------------------------------------------
 
                  *        *        *        *        *
6-Acetylmorphine \4\.......................  10 ng/ml.
 
                 *        *        *        *        *
------------------------------------------------------------------------
\4\ Test for 6-AM when morphine concentration exceeds 2,000 ng/ml.

    Issued this 17th day of November, 1998, at Washington, D.C.
Rodney E. Slater,
Secretary.
[FR Doc. 98-31495 Filed 11-24-98; 8:45 am]
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