[Federal Register Volume 61, Number 61 (Thursday, March 28, 1996)]
[Proposed Rules]
[Pages 13809-13810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7565]
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DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[OST Docket No. OST-96-1176, Notice 96-5]
RIN 2105-AC37
Amendments to Laboratory Certification Requirements
AGENCY: Office of the Secretary, DOT.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This NPRM proposes provisions that would permit drug testing
laboratories located outside the U.S. to participate in the
Department's drug testing program. The certification would happen on
the basis of recommendations from the Department of Health and Human
Services.
DATES: Comments should be received by May 13, 1996. Late-filed comments
will be considered to the extent practicable.
ADDRESSES: Comments should be sent, preferably in triplicate, to Docket
Clerk, Docket No. OST-96-1176, Department of Transportation, 400 7th
Street SW., Room PL-400, Washington, DC, 20590. Comments will be
available for inspection at this address from 9:00 a.m. to 5:30 p.m.,
Monday through Friday. Commenters who wish the receipt of their
comments to be acknowledged should include a stamped, self-addressed
postcard with their comments. The Docket Clerk will date-stamp the
postcard and mail it back to the commenter.
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.
SUPPLEMENTARY INFORMATION: Recently, the Federal Highway Administration
(FHWA) issued a final rule applying its drug and alcohol testing
requirements to foreign-based drivers operating in the United States
(60 FR 49322; September 22, 1995). Under the rule, Canadian and Mexican
drivers who come into the United States will be subject to testing on
the same basis as U.S. drivers, beginning July 1, 1996, for employees
of larger carriers and a year later for employees of smaller carriers.
In any case, Canadian and Mexican employers who collect drug urine
specimens under FHWA rules will be able to have the specimens tested in
U.S. laboratories certified by the Department of Health and Human
Services (DHHS), on the same basis as U.S. employers. In the interest
of facilitating program implementation, the Department hopes that it
will be possible for Mexican and Canadian laboratories to participate
in the program as well.
Canadian and Mexican laboratories may participate in the DOT-
mandated testing program only if their participation is consistent with
the Department's statutory authority. Strict safeguards for the
accuracy and quality of laboratory tests are a key mandate of the
Omnibus Transportation Employee Testing Act of 1991.
The motor carrier portion of the Act (49 U.S.C. 31306(b), which
parallels the other modal sections of the Act), provides that, in
carrying out the requirement to establish a motor carrier drug testing
program, the Secretary ``shall'' develop requirements ``that shall''
(2) For laboratories and testing procedures for controlled
substances, incorporate the Department of Health and Human Services
scientific and technical guidelines dated April 11, 1988, and any
amendments to those guidelines, including mandatory guidelines
establishing--
(A) Comprehensive standards for every aspect of laboratory
controlled substances testing and laboratory procedures to be
applied in carrying out this section, including standards requiring
the use of the best available technology to ensure the complete
reliability and accuracy of controlled substances tests and strict
procedures governing the chain of custody of specimens collected for
controlled substances testing; * * *
(C) Appropriate standards and procedures for periodic review of
laboratories and criteria for certification and revocation of
certification of laboratories to perform controlled substances
testing in carrying out this section.
(3) Require that a laboratory involved in testing under this
section have the capability and facility, at the laboratory, of
performing screening and confirmation tests; * * *
The language of these provisions is clearly mandatory, a point
which the legislative history reinforces. Senate Report 102-54 (May 2,
1991), concerning S. 676, the bill that became the Act, notes, in
response to concerns about testing accuracy and false positive tests,
that ``By incorporating laboratory certification and testing procedures
developed by HHS and DOT * * * the Committee has taken affirmative
steps to ensure accuracy.'' (S. Rept. 102-54 at 7.) Later, in speaking
of the laboratory and other safeguards in the bill, the report says
that
These safeguards are critical to the success of any testing
program. They are designed to ensure that * * * there is
accountability and accuracy of testing. They provide what the
Committee believes are the basic minimums. * * * The Secretary is
urged to carefully review the safeguards in any testing program to
ensure they are adhered to in a vigorous manner. (Id. at 31)
More specifically on laboratory matters, the Committee said that
Incorporating the HHS guidelines relating to laboratory
standards and procedures * * * as DOT has done in Part 40 * * * is
an essential component of the procedural safeguards specified in
this subsection. * * * Realizing that these guidelines may be
subject to future modification, the Committee has acted to specify
that the basic elements of certain provisions now in effect are
mandated, including the need for comprehensive standards and
procedures for all aspects of laboratory testing of drugs * * *
[and] the establishment of standards and procedures for the periodic
review of laboratories and the development of criteria for
laboratory certification or revocation of such certification. (Id.
at 32)
It is noteworthy that Congress explicitly accepts an active DOT
role in establishing and carrying out the laboratory-related provisions
of the statute. What is mandatory is not that one agency or the other
play any particular administrative role in the process, but that the
protections embodied in the DHHS guidelines be applied, through DOT's
rules, to participants in the program. There is no bar in the statutory
language to a DOT rule assigning to DOT the task of reviewing and
certifying laboratories, so long as these actions by DOT are based on
the conformity of the laboratories to DOT's incorporation of DHHS
laboratory standards. Consequently, DOT has broad legal discretion to
take action in the area of drug testing procedures, extending to the
certification of laboratories.
DOT and DHHS are working closely together with respect to the
potential certification of foreign laboratories. As the two agencies
envision the process, there could be two different ways in which
foreign laboratories become certified. First, DHHS could review the
application of the foreign laboratory, in the same manner that it
reviews applications from U.S. laboratories. If the laboratory meets
DHHS standards, DHHS would recommend that DOT certify the laboratory
under DOT
[[Page 13810]]
authority. (The direct certifying authority of DHHS extends only to
laboratories that would participate in the Federal employee testing
program.) Second, DHHS could review the standards and procedures of a
foreign certifying agency. If DHHS determined that the foreign agency
had standards, procedures, and authority equivalent to those of DHHS,
DHHS would recommend to DOT that DOT deem the foreign agency to be an
equivalent certifying authority. Laboratories that the foreign agency
certified would then be permitted to participate in the DOT testing
program.
DOT and DHHS have discussed laboratory issues with officials of
Transport Canada, the Canadian Trucking Association and its affiliates,
and the Standards Council of Canada (a potential laboratory
certification organization in Canada), as well as representatives of
some Canadian laboratories. We have also had discussions with Mexican
officials concerning program and laboratory matters. While a number of
issues remain to be resolved, the Department is proposing a change to
49 CFR Sec. 40.39 to accommodate the possibility that foreign
laboratories may be able to participate in DOT-mandated drug testing.
The proposed amendment would add a new paragraph to authorize the
participation of foreign laboratories in the DOT drug testing program
in the two circumstances outlined above (i.e., based on a
recommendation by DHHS that a particular laboratory meets DHHS
certification requirements, or based on a certification by a foreign
certifying organization whose standards and process had been deemed
equivalent to those of DHHS). It should be emphasized that, if adopted,
the proposed amendment would not have the effect of actually certifying
any foreign laboratories. It would simply put in place a mechanism that
would allow such laboratories to participate, if and when DOT and DHHS
had determined that all issues had been resolved satisfactorily, in
full compliance with DHHS requirements for laboratory certification.
Regulatory Process Matters
The proposed rule is considered to be a nonsignificant rulemaking
under DOT Regulatory Policies and Procedures, 44 FR 11034. It also is a
nonsignificant rule for purposes of Executive Order 12886. The
Department certifies, under the Regulatory Flexibility Act, that the
NPRM, if adopted, would not have a significant economic effect on a
substantial number of small entities. The NPRM would not impose any
costs or burdens on regulated entities, since it deals with a subject
(applying for laboratory certification) that is completely voluntary.
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. The comment period is 45 days
rather than 60 because, in order to permit the Department to certify
foreign laboratories before the July 1, 1996, start date for testing of
foreign drivers, the Department needs to complete this rulemaking on an
expedited basis.
List of Subjects in 49 CFR Part 40
Drug Testing, Alcohol Testing, Reporting and Recordkeeping
Requirements, Safety, Transportation.
For the reasons set forth in the preamble, 49 CFR Part 40 is
proposed to be amended as follows:
PART 40--[AMENDED]
1. The authority citation for Part 40 would continue to read as
follows:
Authority: 49 U.S.C. 102, 301, 322; 49 U.S.C. app. 1301nt., app.
1434nt., app. 2717, app. 1618a.
2. Section 40.39 is proposed to be revised to read as follows:
Sec. 40.39 Use of Certified Laboratories.
(a) Except as provided in paragraph (b) of this section, employers
subject to this part shall use only laboratories certified under the
DHHS ``Mandatory Guidelines for Federal Workplace Drug Testing
Programs,'' April 11, 1988, and subsequent amendments thereto.
(b) Employers subject to this part may also use laboratories
located outside the United States if--
(1) The Department of Transportation, based on a recommendation
from DHHS, has certified the laboratory as meeting DHHS laboratory
certification standards; or
(2) The Department of Transportation, based on a recommendation
from DHHS, has recognized a foreign certifying organization as having
equivalent laboratory certification standards and procedures to those
of DHHS, and the foreign certifying organization has certified the
laboratory pursuant to those equivalent standards and procedures.
Issued this 20th day of March 1996, at Washington, D.C.
Federico Pena,
Secretary of Transportation.
[FR Doc. 96-7565 Filed 3-27-96; 8:45 am]
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