Amendments to Laboratory Certification Requirements

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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