[Federal Register Volume 61, Number 137 (Tuesday, July 16, 1996)]
[Rules and Regulations]
[Pages 37015-37017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18063]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Office of the Secretary of Transportation
49 CFR Part 40
[OST Docket No. OST-96-1532]
RIN 2105-AC37
Amendments to Laboratory Certification Requirements
AGENCY: Office of the Secretary, DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule establishes provisions that would permit drug
testing laboratories located outside the U.S. to participate in the
Department's drug testing program. The Department of Transportation
would take action permitting the laboratories to participate based on
recommendations from the Department of Health and Human Services.
EFFECTIVE DATE: This rule is effective on July 16, 1996.
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 Enforcement and Program Compliance, same
street address, Room 10317, (202) 366-3784.
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. (If Canadian and Mexican laboratories are not
authorized to participate in the program as provided in this rule,
Canadian and Mexican employers must send specimens to DHHS-certified
laboratories in the U.S. for testing.)
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
[[Page 37016]]
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 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. Following these
discussions, the Department proposed a change to 49 CFR 40.39 to
accommodate the possibility that foreign laboratories may be able to
participate in DOT-mandated drug testing (61 FR 13809; March 28, 1996).
The NPRM proposed to 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). The Department received three comments on
the proposal, all of which supported it. Two of the comments sought
assurances that the rule would result in foreign laboratories that
fully met all DHHS requirements, including periodic inspections and re-
certifications.
The Department is adopting the proposal without change. The rule
will result in full compliance with DHHS procedures and standards for
laboratory certification by foreign laboratories authorized to
participate in the program, including inspection and re-certification
provisions. It should be emphasized that the rule does not have the
effect of actually certifying any foreign laboratories. It simply puts
in place a mechanism that would allow such laboratories to participate,
if and when DOT and DHHS determine that all issues had been resolved
satisfactorily, in full compliance with DHHS requirements for
laboratory certification. Once authorized to participate in the DOT
drug testing program by this process, a Canadian or Mexican laboratory
would be on the same footing as any DHHS-certified laboratory
concerning program participation, including the ability to test
specimens collected in the U.S. by U.S. employers.
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
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 deals with a subject (applying for
laboratory certification) that is completely voluntary. Laboratories
that are able to meet DHHS standards are typically not small entities,
in any case. The rule makes it possible for Canadian and Mexican motor
carriers to use laboratories that are closer to them than laboratories
in the U.S., which may result in somewhat lower costs for these
carriers, which include some small entities. 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 rule is being made effective immediately. The Department has
good cause to do so, on the basis that in order to give the Department
the opportunity to authorize foreign laboratories to participate in the
DOT drug testing program by the July 1, 1996, compliance date for
Canadian and Mexican motor carriers, the Department needs this rule to
be in place. Making this rule effective now will permit the Department
to respond in a timely way if DHHS determines that foreign laboratories
or certifying organizations meet DHHS standards. Even if foreign
laboratories are not in a position to be approved for participation by
July 1, it is important that the Department's authority to approve
foreign laboratories be in place, as a matter of good faith on our part
toward our trading partners.
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
amended as follows:
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. 1301nt., app.
1434nt., app. 2717, app. 1618a.
2. Section 40.39 is 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 written
recommendation from DHHS, has certified the laboratory as meeting DHHS
laboratory certification standards or deemed the laboratory fully
equivalent to a laboratory meeting DHHS laboratory certification
standards; or
(2) The Department of Transportation, based on a written
recommendation
[[Page 37017]]
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 9th day of July 1996, at Washington, DC.
Federico Pena,
Secretary of Transportation.
[FR Doc. 96-18063 Filed 7-15-96; 8:45 am]
BILLING CODE 4910-62-P