[Federal Register Volume 75, Number 23 (Thursday, February 4, 2010)]
[Proposed Rules]
[Pages 5722-5732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2315]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-2010-0026]
RIN 2105-AD95


Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Transportation is proposing to amend certain 
provisions of its drug testing procedures dealing with laboratory 
testing of urine specimens. Some of the proposed changes will also 
affect the roles and standards applying to collectors and Medical 
Review Officers. The proposed changes are intended to create 
consistency with new requirements established by the U.S. Department of 
Health and Human Services Mandatory Guidelines.

DATES: Comments to the notice of proposed rulemaking should be 
submitted by April 5, 2010. Late-filed comments will be considered to 
the extent practicable.

ADDRESSES: To ensure that you do not duplicate your docket submissions, 
please submit them by only one of the following means:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting 
comments.
    <bullet> Mail: Docket Management Facility, U.S. Department of 
Transportation, 1200 New Jersey Ave., SE., West Building Ground Floor 
Room W12-140, Washington, DC 20590-0001;
    <bullet> Hand Delivery: West Building Ground Floor, Room W-12-140 
1200 New Jersey Ave., SE., between 9 a.m. and 5 p.m., Monday through 
Friday, except Federal holidays. The telephone number is 202-366-9329;

[[Page 5723]]

    Instructions: You must include the agency name and docket number 
DOT-OST--or the Regulatory Identification Number (RIN) for the 
rulemaking at the beginning of your comments. All comments received 
will be posted without change to http://www.regulations.gov, including 
any personal information provided

FOR FURTHER INFORMATION CONTACT: Mark Snider, Senior Policy Advisor (S-
1), Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey 
Ave., SE., Washington, DC 20590; telephone number 202-366-3784 (voice), 
202-366-3897 (fax), or <a href="/cdn-cgi/l/email-protection#a7cac6d5cc89d4c9cec3c2d5e7c3c8d389c0c8d1"><span class="__cf_email__" data-cfemail="7b161a0910550815121f1e093b1f140f551c140d">[email protected]</span></a> (e-mail).

SUPPLEMENTARY INFORMATION:

Purpose

    In its final rule of December 2000 [65 FR 79562, Dec. 19, 2000], 
the U.S. Department of Transportation (DOT) made significant changes to 
the drug testing rules to include making specimen validity testing 
(SVT) mandatory for the transportation industry contingent upon U.S. 
Department of Health and Human Services (HHS) publishing its Mandatory 
Guidelines on SVT. In late 2001, the DOT amended part 40 [66 FR 41944, 
Aug. 9, 2001] to remove the mandatory requirement because HHS had not 
finalized its Mandatory Guidelines regarding SVT. We said that SVT 
would remain authorized but not required.
    On April 13, 2004, HHS published a Federal Register notice revising 
its Mandatory Guidelines [69 FR 19644] with an effective date of 
November 1, 2004. Among the revisions contained in the HHS Mandatory 
Guidelines were the requirements that laboratories modify substituted 
specimen and diluted specimen testing and reporting criteria. HHS 
revised laboratory requirements for adulterated specimen testing. HHS 
also required each Federal agency to conduct SVT to determine if urine 
specimens collected under HHS Federal Workplace Drug Testing Programs 
have been adulterated or substituted.
    In an interim final rule (IFR) [69 FR 64865, Nov. 9, 2004], the DOT 
changed a number of items in its regulation to make part 40 and the HHS 
Mandatory Guidelines consistent. We did this to avoid conflicting 
requirements that implementation of both rules would have had on 
laboratories and Medical Review Officers (MROs).
    In the 2004 IFR, we indicated that we intended to fully address all 
aspects of the HHS changes to their Mandatory Guidelines in a future 
DOT notice of proposed rulemaking (NPRM). In an NPRM [70 FR 62276, Oct. 
31, 2005], the DOT sought comments to include SVT mandatory for the 
transportation industry, and the instructions that were given to MROs, 
laboratories, and employers with respect to adulterated, substituted, 
diluted, and invalid drug testing results. In a final rulemaking [73 FR 
35961, Jun. 25, 2008] the DOT finalized these requirements to include 
making SVT mandatory for the transportation industry.
    On November 25, 2008, HHS issued a Notice of Revisions to the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs 
(Revisions to Mandatory Guidelines) [73 FR 71858, Nov 28, 2008]. The 
HHS revised some of their requirements for collecting and testing urine 
specimens, initiated requirements for the certification of Instrumented 
Initial Test Facilities (IITFs), and expanded upon the roles of and 
standards for collectors and MROs.
    We are issuing this notice of proposed rulemaking to offer changes 
to 49 CFR Part 40 in an effort to create consistency with this latest 
set of requirements established by HHS.

Principal Policy Issues

Harmonization With HHS

    In this NPRM we are seeking to harmonize our proposals for 
laboratories, collectors, MROs, and employers with the new requirements 
contained in the revised HHS Mandatory Guidelines. Here are the most 
noteworthy of the coordinated proposals:
    1. We propose to modify some of our definitions and add a few new 
definitions in order to make them consistent with the HHS Mandatory 
Guidelines definitions.
    2. We propose to allow DOT employers to choose between a full 
service laboratory and an IITF. An IITF would only be able to provide 
results to employers for negative and negative dilute specimens, as 
well as specimens they reject for testing. All other specimens would be 
forwarded to an HHS certified laboratory.
    3. We propose to modify regulations to add IITFs to the laboratory 
section of this regulation and spell-out how an IITF should perform 
urine testing. An ITTF could conduct Initial Tests and SVT for all DOT 
employer programs. When an IITF discovers a non-negative drug test 
result, it will have to forward that result to a full service 
laboratory to perform a full analysis of the specimen and report the 
results to the employer's MRO.
    4. The DOT is also proposing to adopt the following HHS laboratory 
testing requirements:
    <bullet> Conduct Initial Testing for Methylenedioxymethamphetamine 
(MDMA);
    <bullet> Conduct Confirmatory Testing for MDMA, 
Methylenedioxyamphetamine (MDA), and Methylenedioxyethylamphetamine 
(MDEA);
    <bullet> Conduct Initial Testing for 6-Acetylmorphines.
    <bullet> Lower the Initial Test and Confirmatory Test cutoff 
concentrations for Amphetamines; and
    <bullet> Lower the Initial Test and Confirmatory Test cutoff 
concentrations for Cocaine.
    We would note here that past experience has shown that DOT has 
never deviated from HHS on laboratory testing matters--the drugs for 
which we test, the specimens we test, specimen validity testing values, 
initial and confirmatory cutoff values, and laboratory testing 
processes and procedures, among others. Also, DOT is required by the 
Omnibus Transportation Employee Testing Act of 1991 to adhere with the 
HHS on these important laboratory testing matters.
    5. We are also proposing to amend Appendix B so that IITFs will be 
required to report semi-annual test reports to employers, as 
appropriate. Appendix C would also be modified to require IITFs to 
report semi-annual test data to the DOT.
    6. Finally, the HHS Mandatory Guidelines will require that 
nationally-recognized MRO certification entities or subspecialty boards 
for medical practitioners in the field of medical review must have 
their qualifications, training programs, and examinations approved by 
HHS on an annual basis. The DOT is seeking comment on whether part 40 
should require these groups to be approved. Would the DOT program be 
better served if we sought a shared approval process with the HHS? In 
addition, the DOT is seeking comments on whether part 40, at 49 CFR 
Part 40.121(d), should be amended by removing the requirement that MROs 
must complete 12 Continuing Education Units (CEUs) pertaining to DOT 
and MRO practices every three years, and instead require MROs to be 
recertified every five years by an MRO certification board or 
subspecialty board. We believe this is a cost neutral proposition, and 
may even prove less costly because many MROs obtain both the 12 CEUs 
every 3 years and the MRO recertification every 5 years.
    While we have sought to harmonize our proposed regulations with the 
new

[[Page 5724]]

HHS requirements, there remain some for which we have not proposed 
changes to some of our longstanding procedures. For items left 
unchanged in the HHS Guidelines from previous iterations, we believe 
there is no need to address them again. We have found that our 
procedures have worked well within and for the transportation 
industries. In addition, we must consider program costs and the value 
added in adopting some of the new HHS Mandatory Guidelines procedures.
    For example, the DOT does not propose to require observers to 
receive advanced formalized training to learn about the steps necessary 
to perform a direct observation collection (DO collection). The current 
process of having a qualified and trained collector provide immediate, 
precise, and relevant instructions to an observer at the time of a DO 
collection is very appropriate and has been for years. That way, the 
Department can be assured that the requisite instructions are provided 
each time that a DO collection is required, no matter how many, or few, 
an observer has already accomplished. In addition, the costs associated 
with formally training observers (and the resulting limitation on 
available observers) do not outweigh any minimal benefits to arguably 
be obtained by training observers in advance instead of providing 
timely and relevant instructions on site at the time of the DO 
collection. The DOT is not aware of any cases where it was not 
effective to have the qualified and trained collector instruct the 
observer at the time the DO collection is to occur, and to do so each 
time a DO collection is required.
    Also, the DOT does not propose to change our longstanding 
regulatory position that a collector need not obtain prior approval 
from collection site supervisor before performing a DO collection. 
Requiring collectors to get approval from collection site supervisors 
would create difficult logistical issues that would complicate the 
process. There are numerous instances where the collector is alone or 
does not have immediate access to a collection site supervisor. In 
fact, the collector may be the site supervisor. Many collections occur 
off-site or in the middle of the night where and when supervisors would 
not be available, and requiring consultation with an unavailable 
supervisor would prove onerous and serve only to delay unnecessarily 
the DO process. We believe the collectors should continue to make these 
DO collection decisions and to continue basing those decision upon the 
clear requirements set forth in part 40.
    Also, we will not propose to change the duration of the paperwork 
retention requirement for collectors. HHS will require collectors to 
keep Copy 3 for two years. The DOT believes the current 30 days is 
sufficient in the DOT program. Retention for 30 days has proven a 
sufficient amount of time in which ensure that a CCF copy with the 
employee's signature would be available to the MRO's CCF copy were not 
available. Requiring document retention for three years would greatly 
increase the paperwork burden without any added safety or efficiency 
benefit.
    Under the revised HHS Mandatory Guidelines, Federal agencies will 
be required to audit 5 percent or a maximum of 50 of their collection 
sites. DOT believes that creating a parallel requirement for 
transportation industry employers would be very expensive to employers 
in the DOT program in terms of time and resources, with few efficiency 
and/or safety benefits. The DOT would anticipate seeing more effective 
monitoring by the collection site parent organizations in an effort to 
ensure employers that sites under their organization umbrellas, with 
which employers are contracting, are properly conducting collections. 
The DOT Agencies and United States Coast Guard also provide on-site 
audits and inspections of collection sites. They have also increased 
their efforts to include mock collections and more clandestine 
inspections. All of these provide added oversight to determine whether 
collection site personnel are properly performing collections and 
whether collection sites adhere to the DOT's security and integrity 
requirements.
    The revised HHS Mandatory Guidelines will require at least 3 
percent blind specimen testing, compared to DOT's current 1 percent. We 
believe our current requirements represent a good balance between 
considerations of reducing burdens and maintaining an effective check 
upon laboratory performance. We have had few if any laboratory accuracy 
problems over the history of the program, and we believe that we can 
continue to ensure that this pattern continues while reducing burdens 
and costs on participants. Coupled with the HHS requirements and the 
additional proficiency testing required for laboratory certification, 
the blinds submitted via the DOT requirements are quite ample.
    The new HHS Mandatory Guidelines require MROs to retain records for 
two years. The current DOT regulations currently require that MROs to 
follow the employer's recordkeeping requirements, one year for negative 
results and 5 years for non-negative results. The DOT is comfortable 
with the existing provision, but seeks comments about what types of MRO 
records should be covered under the record keeping requirements. Is it 
normal practice for an MRO to include in his or her paperwork personal 
notes and conversations with laboratory personnel? What other types of 
records would MROs normally be required to keep as part of this 
paperwork requirement? The DOT would like for MROs to provide comment 
upon what they believe are records DOT inspectors or auditors could 
expect to see when reviewing MROs records as part of the overall 
compliance audit of a DOT-regulated employer.
    In addition, we propose to limit IITF and MRO relationships similar 
to the limits placed upon laboratory and MRO relationships. We are also 
proposing that MROs treat MDMA positives like any other Schedule I drug 
for which we test: MROs must not accept an assertion that there is a 
legitimate medical explanation for the presence of MDMA in a specimen.

Section-by-Section NPRM Issues

    1. Index Changes--We would modify some existing section headings 
and add new section headings in order to reflect regulation text 
changes. All told, 39 sections of our regulation are proposed to be 
modified or added.
    2. Definition changes--In order to align our definitions section 
(Sec.  40.3) more closely with definitions contained in the HHS 
Mandatory Guidelines, we propose to modify some of our existing 
definitions and add some new ones. We revised the definitions of 
``adulterated specimen,'' ``blind specimen or blind performance test 
specimen,'' ``cancelled test,'' ``confirmatory drug test,'' 
``confirmatory validity test,'' ``initial drug test (also known as a 
screening drug test,'' ``invalid result,'' ``laboratory,'' ``limit of 
detection (LOD),'' ``performance testing (PT) sample,'' ``primary 
specimen,'' and ``split specimen.'' We also added several new 
definitions.
    3. Appendix Items--At Appendix B, we propose to modify the semi-
annual laboratory report to employers so that it will have the same 
information required by the HHS Mandatory Guidelines. The report will 
also require laboratories to report the number of positive results for 
MDMA. We also provide additional clarification to IITFs about what data 
they should report and how they are to report it to employers. The 
proposed changes, while not dramatic, will help laboratories and IITFs 
avoid needing

[[Page 5725]]

two different report formats, one for DOT and one for HHS.
    At Appendix C, we provide clarification to IITFs about what data 
they should report and how they are to report it to the DOT on a semi-
annual basis.

Other Issues

    The Department is aware that HHS is preparing an NPRM which will 
propose changes to the current Federal Drug Testing Custody and Control 
Form (CCF). If changes are adopted by HHS, they would likely have some 
impact upon the DOT procedural requirements for collectors, 
laboratories, and MRO's. When the HHS rule on the revised CCF is 
published, the Department will make necessary changes to part 40.
    Some individuals have recently raised issues about screening and 
confirmation of 6-AM at 10 ng/mL without the need show the presence of 
morphine in the specimen. If there are factual, evidence-based 
concerns, we would like to hear them. If there are such valid concerns, 
are there viable laboratory testing resolutions to the issue? Or must 
the regulation provide additional instruction to MROs about how to deal 
with a positive heroin result? What would that instruction be?

Regulatory Analyses and Notices

    The statutory authority for this rule derives from the Omnibus 
Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 
5331, 20140, 31306, and 45101 et seq.) and the Department of 
Transportation Act (49 U.S.C. 322).
    This rule is not significant for purposes of Executive Order 12866 
or the DOT's regulatory policies and procedures. It proposes 
modifications to our overall part 40 procedures and is intended only to 
further align our laboratory procedures and processes, as well as a few 
collection and MRO procedures, with those requirements that are being 
directed by the HHS Guidelines which were considered non-significant. 
Their economic effects will be negligible for DOT regulated employers. 
Consequently, the DOT certifies, under the Regulatory Flexibility Act, 
this rule will not have a significant economic impact on a substantial 
number of small entities.
    We would note that all HHS-certified laboratories must have the 
capability to accurately test for MDMA in order to pass certification 
requirements of the National Laboratory Certification Program. In 
addition, Federal Agency employee testing programs will have to test 
for MDMA, as well as amphetamine and cocaine at the new cutoffs. Our 
harmonizing on these matters will only bring clarity and consistency to 
the efforts of the Federal testing programs, programs that are internal 
to the Federal Government and those that are regulated by the Federal 
Government.
    HHS has estimated that there may be 10% more users of amphetamine 
and cocaine identified using the lowered cutoffs and testing for new 
drugs. HHS says the incidence and prevalence of amphetamines and 
cocaine use is very low. Our data supports this fact. From July 1, 2008 
through June 30, 2009, the DOT's regulated-transportation industry 
program had 14,440 amphetamine positive and 15,675 cocaine positive 
laboratory results in the 5,444,255 total test results reported. These 
relatively small numbers mean that MRO review costs and burdens 
resulting from additional requirements in the proposed rule should be 
minimal.
    In the DOT-regulated industries, more positive results should not 
impose a significant economic impact or burdens on testing 
laboratories. The Department has obtained information on costs for MDMA 
and 6-AM testing at 11 laboratories representing about 3.6 million DOT 
tests, approximately 67 percent of the 5,444,255 tests mentioned above 
for the July 2008--June 2009 period. Because the cost per test varies 
among laboratories (from a low of $0.06 per MDMA or 6-AM test to a high 
of $1.27 per test for MDMA tests and $2.27 per test for 6-AM tests), 
appearing to depend in part on the volume of tests at each laboratory, 
the Department calculated a weighted average cost per test for the 
industry. Given the number of tests conducted by each laboratory, MDMA 
tests would have cost a weighted average of $0.09 per test; 6-AM tests 
would have a weighted average cost of $0.26 per test. The actual dollar 
cost of the tests at the 11 laboratories would have been $392,125 for 
MDMA, $569,024 for 6-AM, and $961,419 combined. Extrapolating the 
weighted average costs per test to the 100 percent of the DOT tests 
would result in an estimated cost of $489,982 for MDMA tests, $871,081 
for 6-AM tests, and $1,361,063 combined.
    We have concluded that this rule is not significant for purposes of 
Executive Order 12866 or the DOT's regulatory policies and procedures. 
In addition to its low costs, it proposes modifications to our overall 
part 40 procedures and is intended only to further align our laboratory 
procedures and processes, as well as some collection and MRO 
procedures, in order to harmonize DOT procedures with requirements that 
are being directed by HHS Mandatory Guidelines, which were themselves 
deemed to be non-significant rules.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedures, Alcohol abuse, Alcohol 
testing, Drug abuse, Drug testing, Laboratories, Reporting and 
recordkeeping requirements, Safety, Transportation.

    Issued this 20th day of January 2010 at Washington, DC.
Ray LaHood,
Secretary of Transportation.

    For reasons discussed in the preamble, the Department of 
Transportation proposes to amend part 40 of Title 49 Code of Federal 
Regulations, as follows:

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

    1. The authority citation for 49 CFR Part 40 continues to read as 
follows:

    Authority: 40 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
54101 et seq.

    2. Section 40.3 is amended as follows:
    A. Revise the definitions of Adulterated specimen, Blind Specimen 
or blind performance test specimen, Cancelled test, Confirmatory drug 
test, Initial drug test, Invalid result, Laboratory, and Limit of 
Detection.
    B. Add definitions of Alternate Responsible Technician, Certifying 
Scientist (CS), Certifying Technician (CT), Instrumented Initial Test 
Facility (IITF), Limit of Quantitation, Negative result, Positive 
result, Reconfirmed, Rejected for testing, Responsible Person (RP), 
Responsible Technician (RT), and Split specimen collection in 
alphabetical order.
    The revisions and additions read as follows:


Sec.  40.3  What do the terms used in this regulation mean?

* * * * *
    Adulterated specimen. A specimen that has been altered, as 
evidenced by test results showing either a substance that is not a 
normal constituent for that type of specimen or showing an abnormal 
concentration of an endogenous substance.
* * * * *
    Alternate Responsible Technician. The person who assumes 
professional, organizational, educational, and administrative 
responsibility for the day-to-day management of the HHS-certified IITF 
when the responsible

[[Page 5726]]

technician is unable to fill these obligations.
* * * * *
    Blind Specimen or blind performance test specimen. A specimen 
submitted to an HHS-certified laboratory or an HHS-certified IITF for 
quality control testing purposes, with a fictitious identifier, so that 
the laboratory or IITF cannot distinguish it from an employee specimen.
* * * * *
    Cancelled test. The result reported by the MRO to the employer when 
a specimen has been reported to the MRO as invalid result (and the 
donor has no legitimate explanation) or rejected for testing, when a 
split specimen fails to reconfirm, or when the MRO determines that a 
fatal flaw or unrecovered correctable error exists in the forensic 
records.
    Certifying Scientist (CS). The individual responsible for verifying 
the chain of custody and scientific reliability of any test result 
reported by an HHS-certified laboratory.
    Certifying Technician (CT). The individual responsible for 
verifying the chain of custody and scientific reliability of negative, 
negative/dilute, and rejected for testing results reported by a 
laboratory or IITF.
* * * * *
    Confirmatory drug test. A second analytical procedure performed on 
a different aliquot of the original specimen to identify and quantify 
the presence of a specific drug or drug metabolite.
* * * * *
    Initial drug test. The test used to differentiate a negative 
specimen from one that requires further testing for drugs or drug 
metabolites.
* * * * *
    Instrumented Initial Test Facility (IITF). A permanent location 
where initial testing, reporting of results, and recordkeeping are 
performed under the supervision of a responsible technician. Any U.S. 
IITF certified by HHS under the National Laboratory Certification 
Program as meeting the IITF minimum standards of Subpart I of the HHS 
Mandatory Guidelines for Federal Workplace Drug Testing Programs; or, 
in the case of foreign laboratories, an IITF approved for participation 
by DOT under this part. (The HHS Mandatory Guidelines for Federal 
Workplace Drug Testing Programs are available on the Internet at http://www.health.org/workpl.htm or from the Division of Workplace Programs, 
1 Choke Cherry Road, Room 2-1035, Rockville, MD 20857).
* * * * *
    Invalid result. The result reported by an HHS-certified laboratory 
in accordance with the criteria established in HHS Guidelines when a 
positive, negative, adulterated, or substituted result cannot be 
established for a specific drug or specimen validity test.
    Laboratory. A permanent location where initial and confirmatory 
testing, reporting of results, and recordkeeping is performed under the 
supervision of a responsible person. Any U.S. laboratory certified by 
HHS under the National Laboratory Certification Program as meeting the 
laboratory minimum standards of Subpart I of the HHS Mandatory 
Guidelines for Federal Workplace Drug Testing Programs; or, in the case 
of foreign laboratories, a laboratory approved for participation by DOT 
under this part.
    Limit of Detection. The lowest concentration at which a measurand 
can be identified, but (for quantitative assays) the concentration 
cannot be accurately calculated.
* * * * *
    Limit of Quantitation. For quantitative assays, the lowest 
concentration at which the identity and concentration of the measurand 
can be accurately established.
* * * * *
    Negative result. The result reported by an HHS-certified laboratory 
or an HHS-certified IITF to an MRO when a specimen contains no drug or 
the concentration of the drug is less than the cutoff concentration for 
that drug or drug class and the specimen is a valid specimen.
* * * * *
    Positive result. The result reported by an HHS-certified laboratory 
when a specimen contains a drug or drug metabolite equal to or greater 
than the cutoff concentration.
* * * * *
    Reconfirmed. The result reported for a split specimen when the 
second laboratory is able to corroborate the original result reported 
for the primary specimen.
* * * * *
    Rejected for testing. The result reported by an HHS-certified 
laboratory or HHS-certified IITF when no tests are performed for a 
specimen because of a fatal flaw or a correctable flaw that is not 
corrected.
    Responsible Person (RP). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of the HHS-certified laboratory.
    Responsible Technician (RT). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of the HHS-certified IITF.
* * * * *
    Split specimen collection. A collection in which the urine 
collected is divided into two separate specimen bottles, the primary 
specimen (Bottle A) and the split specimen (Bottle B).
* * * * *
    3. In Sec.  40.13, paragraph (c) is revised, to read as follows:


Sec.  40.13  How do DOT drug and alcohol tests relate to non-DOT tests?

* * * * *
    (c) Except as provided in paragraph (d) of this section, you must 
not perform any tests on DOT urine or breath specimens other than those 
specifically authorized by this part or DOT agency regulations. For 
example, you must not test a DOT urine specimen for additional drugs; 
and a laboratory or IITF is prohibited from making a DOT urine specimen 
available for a DNA test or other types of specimen identity testing.
* * * * *
    4. Section 40.27 is revised, to read as follows:


Sec.  40.27  May an employer require an employee to sign a consent or 
release in connection with the DOT drug and alcohol testing program?

    No, as an employer, you must not require an employee to sign a 
consent, release, waiver of liability, or indemnification agreement 
with respect to any part of the drug or alcohol testing process covered 
by this part (including, but not limited to, collections, laboratory or 
IITF testing, MRO and SAP services).
    5. In Sec.  40. 41, paragraph (c) is revised, to read as follows:


Sec.  40.41  Where does a urine collection for a DOT drug test take 
place?

* * * * *
    (c) If you are operating a collection site, you must have all 
necessary personnel, materials, equipment, facilities and supervision 
to provide for the collection, temporary storage, and shipping of urine 
specimens to a laboratory or IITF, and a suitable clean surface for 
writing.
* * * * *
    6. In Sec.  40.45, paragraphs (b) and (d) are revised, to read as 
follows:


Sec.  40.45  What form is used to document a DOT urine collection?

* * * * *
    (b) You must not use a non-Federal form or an expired Federal form 
to

[[Page 5727]]

conduct a DOT urine collection. As a laboratory or IITF, C/TPA or other 
party that provides CCFs to employers, collection sites, or other 
customers, you must not provide copies of an expired Federal form to 
these participants. You must also notify these participants that they 
must not use an expired Federal form.
* * * * *
    (d) Under no circumstances may the CCF transmit personal 
identifying information about an employee (other than a social security 
number (SSN) or other employee identification (ID number)) to a 
laboratory or IITF.
* * * * *
    7. Section 40.51 is revised, to read as follows:


Sec.  40.51  What materials are used to send urine specimens to the 
laboratory or IITF?

    (a) Except as provided in paragraph (b) of this section, you must 
use a shipping container that adequately protects the specimen bottles 
from shipment damage in the transport of specimens from the collection 
site to the laboratory or IITF.
    (b) You are not required to use a shipping container if a 
laboratory or IITF courier hand-delivers the specimens from the 
collection site to the laboratory or IITF.
    8. In Sec.  40.73, paragraphs (a)(2), (a)(8)(iii), and (b) are 
revised, to read as follows:


Sec.  40.73  How is the collection process completed?

    (a) * * *
    (2) Complete the chain of custody on the CCF (Step 4) by printing 
your name (Note: You may pre-print your name), recording the time and 
date of the collection, signing the statement, and entering the name of 
the delivery service transferring the specimen to the laboratory or 
IITF,
    (8) * * *
    (iii) If a laboratory or IITF courier hand-delivers the specimens 
from the collection site to the laboratory or IITF, prepare the sealed 
plastic bag for shipment as directed by the courier service.
* * * * *
    (b) As a collector or collection site, you must ensure that each 
specimen you collect is shipped to a laboratory or IITF as quickly as 
possible, but in any case within 24 hours or during the next business 
day.
    9. In Sec.  40.81, the section heading and paragraphs (b) through 
(d) are revised, and paragraphs (e) and (f) are added, to read as 
follows:


Sec.  40.81  What laboratories or IITFs may be used for DOT drug 
testing?

* * * * *
    (b) As an IITF located in the U.S., you are permitted to 
participate in DOT drug testing only if you are certified by HHS under 
the NLCP for initial testing required under this part.
    (c) As a drug testing laboratory located in Canada or Mexico which 
is not certified by HHS under the NLCP, you are permitted to 
participate in DOT drug testing only if:
    (1) The DOT, based on a written recommendation from HHS, has 
approved your laboratory as meeting HHS laboratory verification 
standards, or deemed your laboratory or IITF fully equivalent to a 
laboratory meeting HHS laboratory certification standards for testing 
required under this part; or
    (2) The DOT, based on a written recommendation from HHS, has 
recognized a Canadian or Mexican certifying organization as having 
equivalent laboratory certification standards and procedures to those 
of HHS, and the Canadian or Mexican certifying organization has 
certified your laboratory under those equivalent standards and 
procedures.
    (d) As an IITF located in Canada or Mexico which is not certified 
by HHS under the NLCP, you are permitted to participate in DOT drug 
testing only if:
    (1) The DOT, based on a written recommendation from HHS, has 
approved your IITF as meeting HHS laboratory verification standards, or 
deemed your laboratory or IITF fully equivalent to a laboratory meeting 
HHS laboratory certification standards for testing required under this 
part; or
    (2) The DOT, based on a written recommendation from HHS, has 
recognized a Canadian or Mexican certifying organization as having 
equivalent IITF certification standards and procedures to those of HHS, 
and the Canadian or Mexican certifying organization has certified your 
IITF under those equivalent standards and procedures.
    (e) As a laboratory or IITF participating in the DOT drug testing 
program, you must comply with the requirements of this part. You must 
also comply with all applicable requirements of HHS in testing DOT 
specimens, whether or not the HHS requirements are explicitly stated in 
this part.
    (f) If DOT determines that you are in noncompliance with this part, 
you could be subject to PIE proceedings under Subpart R of this part. 
If the Department issues a PIE with respect to you, you are ineligible 
to participate in the DOT drug testing program even if you continue to 
meet the requirements of paragraph (a), (b), (c), or (d) of this 
section.
    10. In Sec.  40.83, the section heading, the introductory text, and 
paragraphs (h)(1)(i), (h)(1)(iii), (h)(1)(iv), (h)(2), and (i) are 
revised, to read as follows:


Sec.  40.83  How do laboratories or IITFs process incoming specimens?

    As the laboratory or IITF, you must do the following when you 
receive a DOT specimen from a collection site:
    (a) You are authorized to receive only copy (1) of the CCF. You are 
not authorized to receive other copies of the CCF nor any copies of the 
alcohol testing form.
* * * * *
    (h) * * *
    (1) * * *
    (i) The primary specimen appears to have leaked out of its sealed 
bottle and the laboratory believes a sufficient amount of urine exists 
in the split specimen to conduct all appropriate primary laboratory or 
IITF testing; or
    (ii) * * *
    (iii) The laboratory or IITF opens the split specimen instead of 
the primary specimen, the primary specimen remains sealed, and the 
laboratory or IITF believes a sufficient amount of urine exists in the 
split specimen to conduct all appropriate primary laboratory or IITF 
testing; or
    (iv) The primary specimen seal is broken but the split specimen 
remains sealed and the laboratory or IITF believes a sufficient amount 
of urine exists in the split specimen to conduct all appropriate 
primary laboratory testing.
    (2) In situations outlined in paragraph (h)(1) of this section, the 
laboratory or IITF shall mark through the ``A'' and write ``B,'' then 
initial and date the change. A corresponding change shall be made to 
the other bottle by marking through the ``B'' and writing ``A,'' and 
initialing and dating the change.
    (i) A notation shall be made on Copy 1 of the CCF (Step 5a) and on 
any laboratory or IITF internal chain of custody documents, as 
appropriate, for any fatal or correctable flaw.
    11. A new Sec.  40.84 is added, to read as follows:


Sec.  40.84  How do laboratories process and test specimens received 
from an IITF?

    (a) As a laboratory, you must process each specimen received from 
an IITF you must do so following the appropriate procedures outlined in 
the HHS Mandatory Guidelines.
    (b) You must test each specimen received from an IITF in the same 
manner as if it had not been previously tested.

[[Page 5728]]

    12. Section 40.85 is revised, to read as follows:


Sec.  40.85  For what drugs do laboratories or IITFs test?

    As a laboratory or IITF, you must test for the following five drugs 
or classes of drugs in a DOT drug test. You must not test ``DOT 
specimens'' for any other drugs.
    (a) Marijuana metabolites.
    (b) Cocaine metabolites.
    (c) Amphetamines.
    (d) Opiate metabolites.
    (e) Phencyclidine (PCP).
    13. Section 40.87 is revised, to read as follows:


Sec.  40.87  What are the cutoff concentrations for initial and 
confirmation tests?

    (a) As a laboratory, you must use the Initial Test and Confirmatory 
Test cutoff concentrations displayed in the following table. As an 
IITF, you must use the Initial Test cutoff concentrations displayed in 
the following table. All cutoff concentrations are expressed in 
nanograms per milliliter (ng/mL). The table follows:

----------------------------------------------------------------------------------------------------------------
                                       Initial test cutoff      Confirmatory test      Confirmatory test cutoff
        Initial test analyte              concentration              analyte                concentration
----------------------------------------------------------------------------------------------------------------
Marijuana metabolites..............  50 ng/mL..............  THCA \1\..............  15 ng/mL.
Cocaine metabolites................  150 ng/mL.............  Benzoylecgonine.......  100 ng/mL.
Opiate metabolites:
    Codeine/Morphine \2\...........  2000 ng/mL............  Codeine...............  2000 ng/mL.
                                                             Morphine..............  2000 ng/mL.
    6-Acetylmorphine...............  10 ng/mL..............  6-Acetylmorphine......  10 ng/mL.
    Phencyclidine..................  25 ng/mL..............  Phencyclidine.........  25 ng/mL.
Amphetamines: \3\
    AMP/MAMP \4\...................  500 ng/mL.............  Amphetamine...........  250 ng/mL.
                                                             Methamphetamine \5\...  250 ng/mL.
    MDMA \6\.......................  500 ng/mL.............  MDMA..................  250 ng/mL.
                                                             MDA \7\...............  250 ng/mL.
                                                             MDEA \8\..............  250 ng/mL.
----------------------------------------------------------------------------------------------------------------
\1\ Delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
\2\ Morphine is the target analyte for codeine/morphine testing.
\3\ Either a single initial test kit or multiple initial test kits may be used provided the single test kit
  detects each target analyte independently at the specified cutoff.
\4\ Methamphetamine is the target analyte for amphetamine/methamphetamine testing.
\5\ To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration
  equal to or greater than 100 ng/mL.
\6\ Methylenedioxymethamphetamine (MDMA).
\7\ Methylenedioxyamphetamine (MDA).
\8\ Methylenedioxyethylamphetamine (MDEA).

     (b) As a laboratory or IITF, on an initial drug test you must 
report a result below the cutoff concentration as negative.
    (c) If the result is at or above the cutoff concentration:
    (1) As a laboratory, you must conduct a confirmation test.
    (2) As an IITF, you must forward the specimen and its split to an 
HHS-certified laboratory; and you must do so following the appropriate 
procedures outlined in the HHS Mandatory Guidelines.
    (d) As a laboratory, on a confirmation drug test you must report a 
result below the cutoff concentration as negative and a result at or 
above the cutoff concentration as confirmed positive.
    (e) As a laboratory, you must report quantitative values for 
morphine or codeine at 15,000 ng/mL or above.
    14. In Sec.  40.89, the section heading and paragraph (b) are 
revised, to read as follows:


Sec.  40.89  What is validity testing, and are laboratories or IITFs 
required to conduct it?

* * * * *
    (b) As a laboratory or IITF you must conduct validity testing.
    15. Section 40.91 is revised to read as follows:


Sec.  40.91  What validity tests must laboratories and IITFs conduct on 
primary specimens?

    As a laboratory or IITF, when you conduct validity testing under 
Sec.  40.89, you must conduct it in accordance with the requirements of 
this section; and you must ensure that the following specimen validity 
tests are conducted on each specimen:
    (a) You must determine the creatinine concentration on every 
specimen;
    (b) You must determine the specific gravity on every specimen for 
which the creatinine concentration is less than 20 mg/dL;
    (c) You must determine the pH on every specimen; and
    (d) You must perform one or more specimen validity tests for 
oxidizing adulterants on every specimen.
    (e) If a specimen exhibits abnormal physical characteristics (e.g., 
unusual odor or color, semi-solid characteristics), causes reactions or 
responses characteristic of an adulterant during initial or 
confirmatory drug tests (e.g., non-recovery of standards, unusual 
response), or contains an unidentified substance that interferes with 
the confirmatory analysis, then additional testing may be performed.
    (f) As a laboratory, if you determine that the specimen is invalid 
and HHS Guidelines direct you to contact the MRO, you must contact the 
MRO and together decide if testing the primary specimen by another HHS 
certified laboratory would be useful in being able to report a positive 
or adulterated test result.
    (g) As an IITF, if you determine that a specimen is adulterated, 
substituted, or invalid you must forward that specimen and its split to 
a HHS certified laboratory.
    16. A new Sec.  40.92 is added to read as follows:


Sec.  40.92  What specimen validity test criteria must be met in order 
for an IITF to send specimens to an HHS-certified laboratory?

    (a) As an IITF, you must forward specimens to an HHS-certified 
laboratory when the creatinine test result is equal to or less than 5.0 
mg/dL or when the screening specific gravity test result is less than 
1.002.
    (b) As an IITF, you must forward specimens to an HHS-certified

[[Page 5729]]

laboratory when the pH is less than 4.5 or equal to or greater than 
9.0.
    (c) As an IITF, your must forward specimens to an HHS-certified 
laboratory when the nitrite concentration is equal to or greater than 
200 mcg/mL must be forwarded to an HHS-certified laboratory.
    (d) As an IITF, you must forward specimens to an HHS-certified 
laboratory if the oxidizing adulterant result is equal to or greater 
than the cutoff.
    (e) As an IITF, you must forward specimens to an HHS-certified 
laboratory in accordance with the invalid test result criteria required 
by the HHS Guidelines.
    17. A new Sec.  40.98 is added to read as follows:


Sec.  40.98  What do IITFs report and how do they report it?

    (a) As an IITF, you may only report negative results and rejected 
for testing results.
    (b) When a specimen is found to be negative, you must report the 
test result as being one of the following:
    (1) Negative, or
    (2) Negative-dilute, with numerical values for creatinine and 
specific gravity. The creatinine values must be greater than 5 mg/dL 
but less than 20 mg/dL; and the specific gravity values must be equal 
to or greater than 1.002 but less than 1.003.
    (c) As an IITF, you must report the results directly, and only, to 
the MRO at his or her place of business. You must not report results to 
or through the DER or a service agent (e.g., C/TPA).
    (1) You must fax, courier, mail, or electronically transmit a 
legible image or copy of the fully-completed Copy 1 of the CCF which 
has been signed by the certifying technician, or you may provide the 
IITF results report electronically (i.e., computer data file).
    (i) If you elect to provide electronically the IITF results report, 
you must include the following elements, as a minimum, in the report 
format:
    (A) IITF name and address;
    (B) Employer's name (you may include I.D. or account number);
    (C) Medical review officer's name;
    (D) Specimen I.D. number;
    (E) Donor's SSN or employee I.D. number, if provided;
    (F) Reason for test, if provided;
    (G) Collector's name and telephone number;
    (H) Date of the collection;
    (I) Date received at the IITF;
    (J) Certifying Technician's name;
    (K) Date Certifying Technician released the results;
    (L) Results (i.e., Negative, Negative-Dilute (with values for 
creatinine and specific gravity), or Rejected for Testing (with 
reason).
    (ii) [Reserved]
    (2) [Reserved]
    (d) As an IITF, any primary specimen that tested positive, 
adulterated, substituted, or invalid you must forward the remaining 
specimen and split specimen to a HHS certified laboratory, following 
the procedures outlined in the HHS Mandatory Guidelines.
    18. A new Sec.  40.100 is added to read as follows


Sec.  40.100  How long must an IITF retain a specimen?

    A specimen that is negative, negative-dilute, or rejected for 
testing is discarded.
    19. Section 40.101 is revised, to read as follows:


Sec.  40.101  What relationship may a laboratory or IITF have with an 
MRO?

    (a) As a laboratory or IITF, you must not enter into any 
relationship with an MRO that creates a conflict of interest or the 
appearance of a conflict of interest with the MRO's responsibilities 
for the employer. You must not derive any financial benefit by having 
an employer use a specific MRO.
    (b) The following are examples of relationships between 
laboratories or IITFs and MROs that the Department regards as creating 
conflicts of interest, or the appearance of such conflicts. This 
following list of examples is not intended to be exclusive or 
exhaustive:
    (1) The laboratory or IITF employs an MRO who reviews test results 
produced by the laboratory or IITF;
    (2) The laboratory or IITF has a contract or retainer with the MRO 
for the review of test results produced by the laboratory or IITF;
    (3) The laboratory or IITF designates which MRO the employer is to 
use, gives the employer a slate of MROs from which to choose, or 
recommends certain MROs;
    (4) The laboratory or ITTF gives the employer a discount or other 
incentive to use a particular MRO;
    (5) The laboratory or IITF has its place of business co-located 
with that of an MRO or MRO staff who review test results produced by 
the laboratory or IITF; or
    (6) The laboratory or IITF permits an MRO, or an MRO's 
organization, to have a financial interest in the laboratory or IITF.
    20. In Sec.  40.103, the section heading, paragraphs (a) and (b), 
paragraph (c) introductory text, paragraph (d) introductory text, and 
paragraph (d)(1) are revised, to read as follows:


Sec.  40.103  What are the requirements for submitting blind specimens 
to a laboratory or IITF?

    (a) As an employer or C/TPA with an aggregate of 2000 or more DOT-
covered employees, you must send blind specimens to laboratories or 
IITFs you use. If you have an aggregate of fewer than 2000 DOT-covered 
employees, you are not required to provide blind specimens.
    (b) To each laboratory or IITF to which you send at least 100 
specimens in a year, you must transmit a number of blind specimen's 
equivalent to one percent of the specimens you send to that laboratory 
or IITF, up to a maximum of 50 blind specimens in each quarter (i.e., 
January-March, April-June, July-September, October-December). As a C/
TPA, you must apply this percentage to the total number of DOT-covered 
employees' specimens you send to the laboratory or IITF. Your blind 
specimen submissions must be evenly spread throughout the year. The 
following examples illustrate how this requirement works:

    Example 1 to Paragraph (b). You send 2500 specimens to Lab or 
IITF X in Year 1. In this case, you would send 25 blind specimens to 
Lab or IITF X in Year 1. To meet the even distribution requirement, 
you would send 6 in each of three quarters and 7 in the other.
    Example 2 to Paragraph (b). You send 2000 specimens to Lab or 
IITF X and 1000 specimens to Lab or IITF Y in Year 1. In this case, 
you would send 20 blind specimens to Lab or IITF X and 10 to Lab or 
IITF Y in Year 1. The even distribution requirement would apply in a 
similar way to that described in Example 1.
    Example 3 to Paragraph (b). Same as Example 2, except that you 
also send 20 specimens to Lab or IITF Z. In this case, you would 
send blind specimens to Labs or IITFs X and Y as in Example 2. You 
would not have to send any blind specimens to Lab or IITF Z, because 
you sent fewer than 100 specimens to Lab or IITF Z.
    Example 4 to Paragraph (b). You are a C/TPA sending 2000 
specimens to Lab or IITF X in Year 1. These 2000 specimens represent 
200 small employers who have an average of 10 covered employees 
each. In this case you--not the individual employers--send 20 blind 
specimens to Lab or IITF X in Year 1, again ensuring even 
distribution. The individual employers you represent are not 
required to provide any blind specimens on their own.
    Example 5 to Paragraph (b). You are a large C/TPA that sends 
40,000 specimens to Lab or IITF Y in Year 1. One percent of that 
figure is 400. However, the 50 blind specimen per quarter ``cap'' 
means that you need send only 50 blind specimens per quarter, rather 
than the 100 per quarter you would have to send to meet the one 
percent rate. Your annual total would be 200, rather than 400, blind 
specimens.

    (c) Approximately 75 percent of the specimens you submit must be 
negative

[[Page 5730]]

(i.e., containing no drugs, nor adulterated or substituted). 
Approximately 15 percent must be positive for one or more of the five 
drugs involved in DOT tests, and approximately 10 percent must either 
be adulterated with a substance cited in HHS guidance or substituted 
(i.e., having specific gravity and creatinine meeting the criteria of 
Sec.  40.93(b)).
* * * * *
    (d) You must ensure that each blind specimen is indistinguishable 
to the laboratory or IITF from a normal specimen.
    (1) You must submit blind specimens to the laboratory or IITF using 
the same channels (e.g., via a regular collection site) through which 
employees' specimens are sent to the laboratory or IITF.
* * * * *
    21. In Sec.  40.105, the section heading and paragraphs (b) and (c) 
are revised, to read as follows:


Sec.  40.105  What happens if the laboratory or IITF reports a result 
different from that expected for a blind specimen?

* * * * *
    (b) If the unexpected result is a false negative, you must provide 
the laboratory or IITF with the expected results (obtained from the 
supplier of the blind specimen), and direct the laboratory or IITF to 
determine the reason for the discrepancy.
    (c) If the unexpected result is a false positive, adulterated, or 
substituted result, you must provide the laboratory or IITF with the 
expected results (obtained from the supplier of the blind specimen), 
and direct the laboratory or IITF to determine the reason for the 
discrepancy. You must also notify ODAPC of the discrepancy by telephone 
(202-366-3784) or e-mail (addresses are listed on the ODAPC Web site, 
http://www.dot.gov/ost/dapc). ODAPC will notify HHS who will take 
appropriate action.
    22. Section 40.107 is revised, to read as follows:


Sec.  40.107  Who may inspect laboratories or IITFs?

    As a laboratory or IITF, you must permit an inspection, with or 
without prior notice, by ODAPC, a DOT agency, or a DOT-regulated 
employer that contracts with the laboratory or IITF for drug testing 
under the DOT drug testing program, or the designee of such an 
employer.
    23. Section 40.109 is revised, to read as follows:


Sec.  40.109  What documentation must the laboratory or IITF keep and 
for how long?

    (a) As a laboratory or IITF, you must retain all records pertaining 
to each employee urine specimen for a minimum of two years.
    (b) As a laboratory or IITF, you must also keep for two years 
employer-specific data required in Sec.  40.111.
    (c) Within the two-year period, the MRO, the employee, the 
employer, or a DOT agency may request in writing that you retain the 
records for an additional period of time (e.g., for the purpose of 
preserving evidence for litigation or a safety investigation). If you 
receive such a request, you must comply with it. If you do not receive 
such a request, you may discard the records at the end of the two-year 
period.
    24. Section 40.111 is revised, to read as follows:


Sec.  40.111  When and how must a laboratory or IITF disclose 
statistical summaries and other information it maintains?

    (a) As a laboratory or IITF, you must transmit an aggregate 
statistical summary, by employer, of the data listed in Appendix B to 
this part to the employer on a semi-annual basis.
    (1) The summary must not reveal the identity of any employee.
    (2) In order to avoid sending data from which it is likely that 
information about an employee's test result can be readily inferred, 
you must not send a summary if the employer has fewer than five 
aggregate tests results.
    (3) The summary must be sent by January 20 of each year for July 1 
through December 31 of the prior year.
    (4) The summary must also be sent by July 20 of each year for 
January 1 through June 30 of the current year.
    (b) When the employer requests a summary in response to an 
inspection, audit, or review by a DOT agency, you must provide it 
unless the employer had fewer than five aggregate test results. In that 
case, you must send the employer a report indicating that not enough 
testing was conducted to warrant a summary. You may transmit the 
summary or report by hard copy, fax, or other electronic means.
    (c) You must also release information to appropriate parties as 
provided in Sec. Sec.  40.329 and 40.331.
    (d) As a laboratory or IITF, you must transmit an aggregate 
statistical summary of the data listed in Appendix C to this part to 
DOT on a semi-annual basis. The summary must be sent by January 31 of 
each year for July 1 through December 31 of the prior year; it must be 
sent by July 31 of each year for January 1 through June 30 of the 
current year.
    25. Section 40.113 is revised, to read as follows:


Sec.  40.113  Where is other information concerning laboratories or 
IITFs found in this regulation?

    You can find more information concerning laboratories in several 
sections of this part:

Sec.
40.3 Definition.
40.13 Prohibition on making specimens available for other purposes.
40.31 Conflicts of interest concerning collectors.
40.47 Laboratory or IITF rejections of test for improper form.
40.125 Conflicts of interest concerning MROs.
40.175 Role of first laboratory in split specimen tests.
40.177 Role of second laboratory in split specimen tests (drugs).
40.179 Role of second laboratory in split specimen tests 
(adulterants).
40.181 Role of second laboratory in split specimen tests 
(substitution).
40.183-40.185 Transmission of split specimen test results to MRO.
40.201-40.205 Role in correcting errors.
40.329 Release of information to employees.
40.331 Limits on release of information.
40.355 Role with respect to other service agents.

    26. In Sec.  40.123, paragraph (b)(1) is revised, to read as 
follows:


Sec.  40.123  What are the MRO's responsibilities in the DOT drug 
testing program?

* * * * *
    (b) * * *
    (1) Ensuring the review of the CCF on all specimen collections for 
the purposes of determining whether there is a problem that may cause a 
test to be cancelled (see Sec. Sec.  40.199-40.203). As an MRO, you are 
not required to review laboratory or IITF internal chain of custody 
documentation. No one is permitted to cancel a test because you have 
not reviewed this documentation;
* * * * *
    27. Section 40.125 is revised, to read as follows:


Sec.  40.125  What relationship may an MRO have with a laboratory or 
IITF?

    As an MRO, you must not enter into any relationship with an 
employer's laboratory or IITF that creates a conflict of interest or 
the appearance of a conflict of interest with your responsibilities to 
that employer. You must not derive any financial benefit by having an 
employer use a specific laboratory or IITF. For examples of 
relationships between laboratories and MROs that the Department views 
as creating a conflict of interest or the appearance of such a 
conflict, see Sec.  40.101(b).

[[Page 5731]]

    28. In Sec.  40.127, the introductory text and paragraphs (b), 
(c)(2), (d), (g) introductory text, and (g)(3) to read as follows:


Sec.  40.127  What are the MRO's functions in reviewing negative test 
results?

    As the MRO, you must do the following with respect to negative drug 
test results you receive from a laboratory or IITF, prior to verifying 
the result and releasing it to the DER:
* * * * *
    (b) Review the negative laboratory or IITF test result and ensure 
that it is consistent with the information contained on the CCF.
    (c) * * *
    (2) A legible copy (fax, photocopy, image) of Copy 1 of the CCF or 
the electronic laboratory or IITF results report that conveys the 
negative laboratory test result.
    (d) If the copy of the documentation provided to you by the 
collector or laboratory or IITF appears unclear, you must request that 
the collector or laboratory or IITF send you a legible copy.
* * * * *
    (g) Staff under your direct, personal supervision may perform the 
administrative functions of this section for you, but only you can 
cancel a test. If you cancel a laboratory or IITF-confirmed negative 
result, check the ``Test Cancelled'' box (Step 6) on Copy 2 of the CCF, 
make appropriate annotation in the ``Remarks'' line, provide your name, 
and sign, initial or stamp and date the verification statement.
* * * * *
    (3) Your review must, as a minimum, include the CCF, negative 
laboratory or IITF test result, any accompanying corrective documents, 
and the report sent to the employer. You must correct any errors that 
you discover. You must take action as necessary to ensure compliance by 
your staff with this part and document your corrective action. You must 
attest to the quality assurance review by initialing the CCFs that you 
review.
* * * * *
    29. In Sec.  40.151, paragraph (g) is revised, to read as follows:


Sec.  40.151  What are MROs prohibited from doing as part of the 
verification process?

* * * * *
    (g) You must not accept an assertion that there is a legitimate 
medical explanation for the presence of PCP, 6-AM, or MDMA in a 
specimen. There are no legitimate medical explanations for the presence 
of these substances
* * * * *
    30. In Sec.  40.155, paragraph (a) is revised, to read as follows:


Sec.  40.155  What does the MRO do when a negative or positive test 
result is also dilute?

    (a) When the laboratory or IITF reports that a specimen is dilute, 
you must, as the MRO, report to the DER that the specimen, in addition 
to being negative or positive, is dilute.
* * * * *
    31. In Sec.  40.161, the introductory text is revised, to read as 
follows:


Sec.  40.161  What does the MRO do when a drug test specimen is 
rejected for testing?

    As the MRO, when the laboratory or IITF reports that the specimen 
is rejected for testing (e.g., because of a fatal or uncorrected flaw), 
you must do the following:
* * * * *
    32. In Sec.  40.203, paragraphs (a) and (d)(3) are revised, to read 
as follows:


Sec.  40.203  What problems cause a drug test to be cancelled unless 
they are corrected?

    (a) As the MRO, when a laboratory or IITF discovers a ``correctable 
flaw'' during its processing of incoming specimens (see Sec.  40.83), 
the laboratory or IITF will attempt to correct it. If the laboratory or 
IITF is unsuccessful in this attempt, it will report to you that the 
specimen has been ``Rejected for Testing'' (with the reason stated).
* * * * *
    (d) * * *
    (3) The collector uses a non-Federal form or an expired Federal 
form for the test. This flaw may be corrected through the procedure set 
forth in Sec.  40.205(b)(2), provided that the collection testing 
process has been conducted in accordance with the procedures of this 
part in an HHS-certified laboratory or IITF. If the problem is not 
corrected, you must cancel the test.
    33. In Sec.  40.205, paragraphs (b) introductory text and (b)(2) 
are revised, to read as follows:


Sec.  40.205  How are drug test problems corrected?

* * * * *
    (b) If, as a collector, laboratory or IITF, MRO, employer, or other 
person implementing these drug testing regulations, you become aware of 
a problem that can be corrected (see Sec.  40.203), but which has not 
already been corrected under paragraph (a) of this section, you must 
take all practicable action to correct the problem so that the test is 
not cancelled.
* * * * *
    (2) If the problem is the use of a non-Federal form or an expired 
Federal form, you must provide a signed statement (i.e., a memorandum 
for the record). It must state that the incorrect form contains all the 
information needed for a valid DOT drug test, and that the incorrect 
form was used inadvertently or as the only means of conducting a test, 
in circumstances beyond your control. The statement must also list the 
steps you have taken to prevent future use of non-Federal forms or 
expired Federal forms for DOT tests. For this flaw to be corrected, the 
test of the specimen must have occurred at a HHS-certified laboratory 
or IITF where it was tested consistent with the requirements of this 
part. You must supply this information on the same business day on 
which you are notified of the problem, transmitting it by fax or 
courier.
* * * * *
    34. In Sec.  40.208, paragraph (a) is revised, to read as follows:


Sec.  40.208  What problem requires corrective action but does not 
result in the cancellation of a test?

    (a) If, as a laboratory or IITF, collector, employer, or other 
person implementing the DOT drug testing program, you become aware that 
the specimen temperature on the CCF was not checked and the ``Remarks'' 
line did not contain an entry regarding the temperature being out of 
range, you must take corrective action, including securing a memorandum 
for the record explaining the problem and taking appropriate action to 
ensure that the problem does not recur.
* * * * *
    35. In Sec.  40.209, the section heading and paragraphs (a) and 
(b)(9) are revised, to read as follows:


Sec.  40.209  What procedural problems do not result in the 
cancellation of a test and do not require corrective action?

    (a) As a collector, laboratory or IITF, MRO, employer or other 
person administering the drug testing process, you must document any 
errors in the testing process of which you become aware, even if they 
are not considered problems that will cause a test to be cancelled as 
listed in this subpart. Decision about the ultimate impact of these 
errors will be determined by other administrative or legal proceeding, 
subject to limitation of paragraph (b) of this section.
    (b) * * *
    (9) Personal identifying information is inadvertently contained on 
the CCF (e.g., the employee signs his or her name on the laboratory or 
IITF copy 1); or
* * * * *

[[Page 5732]]

    36. In Sec.  40.329, the section heading and paragraph (b) are 
revised, to read as follows:


Sec.  40.329  What information must laboratories, MROs, and other 
service agents release to employees?

* * * * *
    (b) As a laboratory or IITF, you must provide, within 10 business 
days of receiving a written request from an employee, and made through 
the MRO, the records relating to the results of the employee's drug 
test (i.e., laboratory or IITF) report and data package). You may 
charge no more than the cost of preparation and reproduction for copies 
of these records.
* * * * *
    37. In Sec.  40.355, the introductory text, paragraphs (a) through 
(c), and paragraph (l) are revised, to read as follows:


Sec.  40.355  What limitations apply to the activities of service 
agents?

    As a service agent, you are subject to the following limitations 
concerning your activities in the DOT drug and alcohol testing program.
    (a) You must not require an employee to sign a consent, release, 
waiver of liability, or indemnification agreement with respect to any 
part of the drug or alcohol testing process covered by this part 
(including, but not limited to, collections, laboratory or IITF 
testing, MRO, and SAP services). No one may do so on behalf of a 
service agent.
    (b) You must not act as an intermediary in the transmission of drug 
test results from the laboratory or IITF to the MRO. That is, the 
laboratory or IITF must not send results to you, with you in turn 
sending them to the MRO for verification. For example, a practice in 
which the laboratory or IITF transmits results to your computer system, 
and you then assign the results to a particular MRO is not permitted.
    (c) You must not transmit drug test results directly from the 
laboratory or IITF to the employer (by electronic or other means) or to 
a service agent who forwards them to the employer. All confirmed 
laboratory or IITF results must be processed by the MRO before they are 
released to any other party.
* * * * *
    (l) In transmitting documents to laboratories or IITFs, you must 
ensure that you send to the laboratory or IITF that conducts testing 
only the laboratory copy of the CCF. You must not transmit other copies 
of the CCF or any ATFs to the laboratory or IITF.
* * * * *
    38. Appendix B is revised, to read as follows:

Appendix B to Part 40--DOT Drug Testing Semi-Annual Laboratory or IITF 
Report to Employers

Laboratory Report to Employer

    The following items are required on each laboratory report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include Billing Code or ID code)
C/TPA Identification: (where applicable; name and address)
1. Specimen Results Reported (total number)
By Test Reason:
    (a) Pre-employment (number)
    (b) Post-Accident (number)
    (c) Random (number)
    (d) Reasonable Suspicion/Cause (number)
    (e) Return-to-Duty (number)
    (f) Follow-up (number)
    (g) Type of Test Not Noted on CCF (number)
2. Specimens Reported
    (a) Negative (number)
    (b) Negative and Dilute (number)
3. Specimens Reported as Rejected for Testing (total number)
By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
4. Specimens Reported as Positive (total number) By Drug
    (a) Marijuana Metabolite (number)
    (b) Cocaine Metabolite (number)
    (c) Opiates (number)
    (1) Codeine (number)
    (2) Morphine (number)
    (3) 6-AM (number)
    (d) Phencyclidine (number)
    (e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
    (5) MDEA (number)
5. Adulterated (number)
6. Substituted (number)
7. Invalid Result (number)

IITF Report to Employer

    The following items are required on each IITF report:

Reporting Period: (inclusive dates)
IITF Identification: (name and address)
Employer Identification: (name; may include Billing Code or ID code)
C/TPA Identification: (where applicable; name and address)
1. Specimen Results Reported (total number)
By Test Reason:
    (a) Pre-employment (number)
    (b) Post-Accident (number)
    (c) Random (number)
    (d) Reasonable Suspicion/Cause (number)
    (e) Return-to-Duty (number)
    (f) Follow-up (number)
    (g) Type of Test Not Noted on CCF (number)
2. Specimens Reported
    (a) Negative (number)
    (b) Negative and Dilute (number)
3. Specimens Reported as Rejected for Testing (total number)
By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
4. Number of specimens forwarded to an HHS-certified laboratory for 
additional drug testing and/or specimen validity testing.

    39. Appendix C is revised, to read as follows:

Appendix C to Part 40--DOT Drug Testing Semi-Annual Laboratory or IITF 
Report to DOT

    Mail, fax, or e-mail to: U.S. Department of Transportation, 
Office of Drug and Alcohol Policy and Compliance, W62-300, 1200 New 
Jersey Avenue, SE., Washington, DC 20590, Fax: (202) 366-3897, E-
mail: <a href="/cdn-cgi/l/email-protection#39767d78697a6e5c5b74585055795d564d175e564f"><span class="__cf_email__" data-cfemail="da959e9b8a998dbfb897bbb3b69abeb5aef4bdb5ac">[email protected]</span></a>.
    The following items are required on each laboratory report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
1. DOT Specimen Results Reported (number)
2. Negative Results Reported (number)
    Negative (number)
    Negative-Dilute (number)
3. Rejected for Testing Reported (number)
    By Reason (number)
4. Positive Results Reported (number)
    By Drug (number)
5. Adulterated Results Reported (number)
    By Reason (number)
6. Substituted Results Reported (number)
7. Invalid Results Reported (number)
    By Reason (number)

    The following items are required on each IITF report:

Reporting Period: (inclusive dates)
IITF Identification: (name and address)
1. DOT Specimen Results Reported (number)
2. Negative Results Reported (number)
    Negative (number)
    Negative-Dilute (number)
3. Rejected for Testing Reported (number)
    By Reason (number)
4. Specimens forwarded to an HHS-certified laboratory for additional 
testing (number)
    For Drugs (number)
    For SVT (number)

[FR Doc. 2010-2315 Filed 2-3-10; 8:45 am]
BILLING CODE P


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