[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.
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Confirmatory test cutoff
levels (ng/ml)
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* * * * *
6-Acetylmorphine \4\....................... 10 ng/ml.
* * * * *
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\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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