[Federal Register: March 25, 2008 (Volume 73, Number 58)]
[Rules and Regulations]
[Page 15661]
[DOCID:fr25mr08-3]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal Feed; Pyrantel; Technical
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its animal
drug regulations to correct an inadvertent omission in the list of
concentrations of pyrantel tartrate Type A medicated articles approved
for use by Phibro Animal Health. This action is being taken to improve
the accuracy of the animal drug regulations.

DATES: This rule is effective March 25, 2008.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
in 21 CFR 558.485 to correct an inadvertent omission in the list of
concentrations of pyrantel tartrate Type A medicated articles approved
for use by Phibro Animal Health. This action is being taken to improve
the accuracy of the animal drug regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.485   [Amended]

0
2. In Sec.  558.485, in paragraph (b)(1), add ``48,'' in numerical
sequence.

    Dated: March 12, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5928 Filed 3-24-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Proposed Rules]
[Page 5722-5732]
[DOCID:fr04fe10-20]

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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:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the online instructions for submitting
comments.
     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;
     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<PHONE_NUMBER>;

    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<PHONE_NUMBER> (voice),
202-366-3897 (fax), or<EMAIL_ADDRESS>(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:
     Conduct Initial Testing for Methylenedioxymethamphetamine
(MDMA);
     Conduct Confirmatory Testing for MDMA,
Methylenedioxyamphetamine (MDA), and Methylenedioxyethylamphetamine
(MDEA);
     Conduct Initial Testing for 6-Acetylmorphines.
     Lower the Initial Test and Confirmatory Test cutoff
concentrations for Amphetamines; and
     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

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

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

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

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.

    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

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

(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).

    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
* * * * *

    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:<PHONE_NUMBER>, E-
mail<EMAIL_ADDRESS>    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]
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