[Federal Register: June 25, 2008 (Volume 73, Number 123)]
[Rules and Regulations]
[Page 35961-35975]
[DOCID:fr25jn08-29]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket No. OST-2003-15245]
RIN 2105-AD55

Procedures for Transportation Workplace Drug and Alcohol Testing
Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

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SUMMARY: The Department of Transportation is amending certain
provisions of its drug and alcohol testing procedures to change
instructions to collectors, laboratories, medical review officers, and
employers regarding adulterated, substituted, diluted, and invalid
urine specimen results. These changes are intended to create
consistency with specimen validity requirements established by the U.S.
Department of Health and Human Services and to clarify and integrate
some measures taken in two of our own Interim Final Rules. This Final
Rule makes specimen validity testing mandatory within the regulated
transportation industries.

DATES: This rule is effective August 25, 2008.

FOR FURTHER INFORMATION CONTACT: Jim L. Swart, Acting Director (S-1),
U.S. Department of Transportation, Office of Drug and Alcohol Policy
and Compliance, 1200 New Jersey Avenue, SE., Washington, DC 20590;
telephone number<PHONE_NUMBER> (voice),<PHONE_NUMBER> (fax), or
<EMAIL_ADDRESS>(e-mail).

SUPPLEMENTARY INFORMATION:

Background

    The Omnibus Transportation Employee Testing Act of 1991, 49 U.S.C.
31300, et seq., 49 U.S.C. 20100, et seq., 49 U.S.C. 5330, et seq., and
49 U.S.C. 45100, et seq. (the Omnibus Act), requires the U.S.
Department of Transportation (DOT) to use the laboratories certified
by, and testing procedures of, the U.S. Department of Health and Human
Services (HHS) to ensure ``the complete reliability and accuracy of
controlled substances tests.'' Since Congress specifically limited the
scientific testing methodology upon which the DOT can rely in making
its drug and alcohol testing regulations, we follow the HHS scientific
and technical guidelines, including the amendments to their Mandatory
Guidelines.
    In its final rule of December 2000 [65 FR 79526], the U.S.
Department of Transportation (DOT) made specimen validity testing (SVT)
mandatory for the transportation industry contingent upon the HHS
publishing its Mandatory Guidelines on SVT. DOT anticipated that HHS
would, sometime in 2001, amend its Mandatory Guidelines to establish
SVT requirements for HHS-certified laboratories. When it appeared that
HHS would not establish final SVT requirements in 2001, we amended 49
CFR part 40 (part 40) to remove the mandatory requirement. We believed
it advisable to wait until HHS completed its amendment before making
SVT mandatory throughout the transportation industries for all DOT
specimens.
    On August 9, 2001, the DOT amended part 40 [66 FR 41952] to remove
the mandatory requirement because HHS had not finalized its Mandatory
Guidelines regarding SVT. SVT would remain authorized but not required.
    The DOT issued a May 28, 2003 interim final rule (2003 IFR) [68 FR
31626] in response to scientific and medical information suggesting we
modify testing criteria for some specimens that had been considered to
be substituted and ultimately were treated as refusals to test. The
2003 IFR modified how the medical review officer (MRO) would deal with
any substituted result with creatinine concentrations equal to or
greater than 2, but less than or equal to 5 mg/dL [hereafter, ``2-5 mg/
dL range'']. It did not change the HHS substitution criteria that we
had used.
    On April 13, 2004, the 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 requirements that laboratories modify substituted and
diluted specimen testing procedures and reporting criteria. The HHS
also revised

laboratory requirements for adulterated specimen testing and made SVT
mandatory for Federal employee testing under the HHS Federal Workplace
Drug Testing Program.
    In an IFR (2004 IFR) [69 FR 64865] published on November 9, 2004,
the DOT changed a number of items in part 40 to make them consistent
with the HHS Mandatory Guidelines. We did this to avoid conflicting
requirements that implementation of both rules would have had on
laboratories and MROs.
    While the HHS Mandatory Guidelines' approach to substituted test
results allowed DOT to simplify its guidance to MROs on how to deal
with those results, there were several important differences between
the 2004 IFR and the HHS Guidelines. The most important among them was
the fact that SVT, though authorized by part 40 and the 2004 IFR, was
not yet required.
    In the 2004 IFR, we indicated that we intended to fully address all
aspects of the HHS changes to their Mandatory Guidelines in a notice of
proposed rulemaking (NPRM). We also said that we would take into
consideration any subsequent HHS materials (e.g., HHS MRO Manual) and
would update our cost figures for SVT in the context of making SVT
mandatory.
    Subsequently, the DOT published--on October 31, 2005--an NPRM [70
FR 62276] responding to comments made to the 2003 IFR and to the 2004
IFR. The NPRM also proposed making SVT mandatory and included a number
of other proposed technical changes, mostly clarifying the procedures
related to testing and reporting of adulterated, substituted, and
invalid specimens.

Summary of NPRM Comments

    A total of 27 commenters responded to the 2005 NPRM, making 234
separate comments. Eight commenters were individuals with no known
affiliations; seven were MROs representing themselves or their
organizations; two were employers; one was a Third-Party Administrator
(TPA); four represented associations; four represented labor unions;
and one represented a drug testing laboratory.
    Eleven commenters expressed general support for the DOT effort to
establish clear requirements for SVT that were consistent with the HHS
procedures. Of these eleven, one individual thought the SVT rules
should be more rigorous; four others commended the DOT in its efforts;
one TPA thought the effort admirable; two labor unions commended and
supported the DOT's efforts; one association applauded the effort; and
one laboratory supported DOT efforts to bring more consistency on SVT
with the HHS.
    Six commenters specifically supported making SVT mandatory and five
specifically opposed this proposal. Several stated that authorizing SVT
is sufficient to address adulteration and substitution issues. A number
of commenters provided numerous technical suggestions, supported most
of the proposed changes or additions, and were interested in
establishing relevant procedures to address the various issues of
adulterated, substituted, and invalid test results.
    A number of commenters were concerned about the current state of
science related to SVT testing as compared to that of drug testing. At
least two commenters believed the DOT needed to require laboratories to
utilize two separate methodologies for certain SVT. However, this would
require laboratories to change testing protocols that the HHS does not
mandate.
    A number of commenters supported the DOT's proposal to rectify past
problems related to substituted specimens and suggested a number of
options and recommendations. We appreciate the input from the
commenters and considered their comments in the Informational Notice
Regarding Certain Substituted Specimens published in the Federal
Register on September 11, 2007 [72 51887]. Because we addressed those
issues in that notice, we will not deal with them in this final rule.
    A number of commenters raised part 40 issues unrelated to the
proposed SVT issues. We have not addressed these unrelated items in
this preamble because they are outside the scope of the NPRM.
    Finally, the NPRM proposed or asked a number of major policy
questions relevant to SVT. We specifically address major policy issues
in a separate section and address the others in section-by-section
discussions.

Principal Policy Issues

Mandatory Specimen Validity Testing

    The DOT proposed making SVT mandatory, as in the current HHS
Federal employee testing program.
    Most commenters concurred with DOT's proposal to make SVT
mandatory. Some commenters acknowledged this was necessary because the
increase in products designed to adulterate specimens has made
tampering with specimens more prevalent. The commenters also supported
mandatory SVT because it would bring better control over the SVT
process.
    A number of commenters expressed concern that the science of SVT
has yet to evolve to the same level of accuracy, reliability, and
defensibility as the science of drug testing. Some of these commenters
recommended that SVT should remain elective.
    Several commenters believed that the DOT should require all
laboratories to employ two separate SVT methodologies for adulterants
because this would ensure more confirmed adulteration results. The
commenters reasoned that laboratories would be more likely to report
invalid results if they only used one SVT methodology.
    Other comments on mandatory SVT included concerns about costs and
the extent of adulterant testing. Some commenters believed the DOT's
cost estimates for SVT were low. They requested clarification on the
anticipated costs of initiating mandatory testing. Commenters also
expressed concerns that laboratories were not testing for all
adulterants.

DOT Response

    The DOT continues to believe that mandatory testing for specimen
validity is an appropriate response to the use of adulterants and
attempts to subvert the collection and testing process. The HHS
Mandatory Guidelines established SVT requirements with which
laboratories must comply in order to become and remain HHS-certified.
The HHS has stated that its SVT standards are designed to produce the
most accurate, reliable, and correctly interpreted test results.
    Currently, when DOT specimens are tested for validity, the HHS
procedural standards apply. There is no reason to presume that these
standards are scientifically insufficient. Therefore, we will require
that urine specimens tested under the DOT-industry programs will be
subject to the HHS procedural standards for SVT.
    We will continue to utilize HHS instructions to laboratories for
establishing cutoffs and directing laboratory analysis regarding
creatinine levels. Within part 40, we added procedures to allow an
employee to provide evidence to the MRO that he or she can produce a
urine specimen below the 2.0 mg/dL cutoff. We created this procedural
safeguard in the 2000 regulation because a small number of employees
assert they may be capable of providing urine specimens with creatinine
levels below 2.0 mg/dL, and that such low creatinine levels are not the
result of tampering with their specimens. By adding an evidentiary
process for results below the 2.0 mg/dL cutoff, we believe that we have
created

sufficient safeguards to protect employees from being wrongfully
accused of tampering with their specimens.
    The DOT shares the commenters' concerns about laboratories choosing
to use one adulterant testing methodology because using one methodology
instead of two may result in obtaining invalid results rather than
confirmed adulterated results. However, HHS mandates all scientific and
procedural requirements for drug testing at HHS-certified laboratories.
HHS provides guidance to the laboratories on use of a secondary
confirmatory methodology when a laboratory performs confirmatory
adulteration testing. HHS authorizes, but does not require,
laboratories to perform confirmatory adulteration testing. The Omnibus
Act requires the DOT to incorporate the HHS scientific and technical
guidelines, and we do not have the authority to impose additional
scientific and technical requirements upon the laboratories.
    While current laboratory testing data show a slight rise in invalid
results and a slight decline in adulterated results over previous
years, we do not have data based solely upon implementation of full SVT
because the DOT has not required full implementation. As a consequence,
the DOT will initiate permanent 6-month reviews of laboratory data on
DOT-regulated specimens to obtain more specific information about this
issue now that SVT will be mandatory for all DOT-regulated specimens.
We will look at the reasons drug test results are classified as invalid
versus adulterated to determine if use of one methodology instead of
two is likely to cause more invalid results and fewer confirmed
adulterated results. Part 40 requires laboratories to submit to DOT
specific information regarding their SVT following full implementation.
The regulatory text requiring this information is at Sec.  40.111; and
the required data are listed at Appendix C. We will use this
information in our continuing discussions with HHS and others regarding
SVT. We also want the information so that we can know the full scope of
laboratory data on DOT-regulated tests.
    The DOT cost estimates for full SVT and for laboratory data
collections are in the regulatory analyses and notices section of this
preamble.

Requirement for Laboratories To Contact MROs Before Reporting Invalid
Results

    The DOT asked if we should continue to require laboratories to
contact MROs before reporting invalid results.
    Several commenters, mostly MROs, responded to this question and
generally indicated that laboratories are not routinely contacting them
about invalid results as required by HHS and DOT. Some commenters were
concerned that the rule text does not specify whether the MRO or the
laboratory has the final decision on the disposition of the specimen.
Also, the commenters expressed concern about whether the employer would
be required to pay for sending the specimen to another laboratory. One
commenter pointed out that DOT is requiring the MRO to discuss the
result with ``the certifying scientist'' while HHS requires the MRO to
discuss the result with the ``laboratory.'' Some laboratory personnel
other than a certifying scientist, for example the Responsible Person
(RP), may discuss invalids with the MRO. This commenter supported
having the MRO talk with ``a certifying scientist.''

DOT Response

    The rule continues to require laboratories to contact the MRO prior
to reporting an invalid result, a requirement which mirrors the current
HHS Mandatory Guidelines. The fact that some laboratories may not be
following this requirement is not sufficient reason to suspend or
disregard this procedure. The HHS identifies 12 separate criteria for
identifying a specimen as invalid. Of these 12, the first three do not
require laboratory contact with MROs. It is entirely possible that many
of the invalid results fall under these three criteria and may explain
the reason that contact between the laboratories and the MROs appears
lacking. These three criteria are:
    1. Inconsistent creatinine concentration and specific gravity
results;
    2. The pH is greater than or equal to 3 and less than 4.5, or
greater than or equal to 9 and less than 11; or
    3. The nitrite concentration is greater than or equal to 200 mcg/
mL, but less than 500 mcg/mL.
    As indicated before, some laboratory testing methodologies may
differ. If the invalid result is related to the criteria listed in the
HHS Mandatory Guidelines--under sections 2.4(7), (iv) through (xii),
the MRO and laboratory might conclude it is beneficial to conduct
another test at a different laboratory to obtain a result that is not
invalid. This would require a certifying scientist and the MRO to
discuss the benefit of sending the specimen to another laboratory and
to determine which laboratory would be able to conduct the appropriate
test.
    A few commenters requested that DOT specify whether the MRO or a
certifying scientist would make the determination to send a specimen to
another laboratory. The DOT believes this is a mutual decision to be
made by both the MRO and a certifying scientist.
    Regarding payment for additional testing, the DOT's position is
similar to our stance on paying for split specimen testing. Regardless
of who pays or how, it is the employer's responsibility to ensure that
procedures are in place to accomplish the additional testing. We
believe the cost of any additional tests would be less than the
subsequent cost of recollecting under direct observation when the first
laboratory reported the result as invalid.
    One commenter said that the NPRM's reference to the MRO's
conferring with ``the certifying scientist'' should remain ``a
certifying scientist''--as it is in the current rule text. We agree,
and our regulation reflects this.

HHS Blind Specimen Certification Criteria

    The DOT proposed to adopt the HHS blind specimen certification
criteria. HHS provides technical oversight to the laboratories, and
quality control is part of that very important oversight. We did not
receive comments regarding this proposal. Therefore, the DOT has
adopted the HHS criteria for blind specimen certification.

Recollection Under Direct Observation When Creatinine Is in the 2-5 mg/
dL Range

    The DOT proposed adopting the 2004 IFR's approach to the treatment
of negative-dilute specimens with creatinine in the 2-5 mg/dL range,
which requires recollection under direct observation. The DOT requested
comments about continuing this requirement. The majority of commenters
supported the proposal to require recollections under direct
observation for negative-dilute results with creatinine in the 2-5 mg/
dL range.
    Several commenters indicated that there was an increase in positive
results from the directly observed recollections, while others stated
the results were mostly negative. Most of these commenters provided
anecdotal information. However, one commenter's data showed that a
significant number

of the directly observed recollections produced non-negative results.

DOT Response

    The DOT will continue to require the MRO to direct employers to
conduct immediate recollections under direct observation when the
original specimen is reported with a creatinine concentration in the 2-
5 mg/dL range. We think the number of non-negatives produced during
directly observed recollections is significant and justifies continuing
the recollection requirement.
    Although a few individuals claim the ability to produce urine
specimens with this concentration of creatinine, there has been no
conclusive evidence that this is a common occurrence. Concentration of
creatinine at these levels is not the norm. In the interest of public
safety, the DOT believes that a recollection under direct observation
is a reasonable requirement.

HHS Requirement That an MRO Report a Negative Result When a Medical
Explanation for a Substituted Specimen Appears Legitimate

    The DOT proposed not adopting the HHS MRO Manual guidance for an
MRO to report a negative result if the MRO believed there was a
legitimate medical explanation for the substituted specimen. There were
no comments related to this item.

DOT Response

    Under part 40, the MRO will continue to have the ability to verify
substituted specimens with medical explanations as cancelled tests.
Because there are virtually no medical explanations for substituted
results, the MRO must continue to report to DOT the medical basis for
canceling the test.

Section-by-Section Discussion

    The following part of the preamble discusses each of the final
rule's sections, including responses to comments on each section.

Index

    The DOT proposed to modify some existing section headings and add
two new section headings to reflect regulation text changes. Seven
section headings have been modified or added. Two commenters responded
to this proposal and both supported it.

Section 40.3 What do the terms in this regulation mean?

    In order to align more closely the definitions in Sec.  40.3 with
definitions contained in the HHS Mandatory Guidelines, the DOT proposed
modifying some existing definitions and adding several new ones.
    Commenters supported this proposal and responded by making
suggested additions or changes to this section. Several commenters,
especially MROs, recommended adoption of the term ``hyperdilute'' or
``superdilute'' to distinguish references to those negative-dilute
specimens with creatinine concentrations in the 2-5 mg/dL range. They
recommended that positive specimens the MROs downgrade to negatives be
recollected if they are dilute with creatinine concentrations in the 2-
5 mg/dL range. Additionally, the terms ``cancelled-invalid'' and
``confirmatory creatinine and specific gravity tests'' are used in the
text. Commenters asked if these should be included in the definitions.
    The DOT will modify eight definitions and add five new ones. We
will include a definition of the term ``aliquot'' as defined in the HHS
Mandatory Guidelines. For the term ``Oxidizing adulterant'' we did
provide HHS' examples of these agents.
    We will not use of the term ``hyperdilute'' or ``superdilute'' to
describe a dilute specimen with creatinine concentrations in the 2-5
mg/dL range. Laboratories do not report specimens with creatinine
concentrations in the 2-5 mg/dL range as ``hyperdilute'' or
``superdilute'' but rather as dilute with a numerical value. To require
the use of this term in the reporting process would require
laboratories to change their reporting format and the DOT will not
direct them to do that.
    Additionally, some MROs may think that the use of this term would
somehow make it easier for them to report these results to the
designated employer representative (DER). However, even if we adopted
this term, the DERs would still have to be told that the reason for the
test result being ``hyperdilute'' or ``superdilute'' is that the
creatinine concentration fell in the 2-5 mg/dL range. The DOT does not
think that adding a different name to a test result would in any way
improve laboratory and MRO procedures.
    We also proposed to use the term ``cancelled-invalid'' in the NPRM.
However, we will not include this term in the text since laboratories
will not report tests as being ``cancelled-invalid.'' In addition,
current requirements call for the MRO to check the cancelled box on the
Federal Drug Testing Custody and Control Form (CCF) and, on the remarks
line, write that the reason is an invalid result. We think this is
sufficiently clear in describing the test outcome. We will not add
another term to the current lexicon of drug testing results. We use the
term ``cancelled'' in the rule text rather than ``cancelled-invalid.''
    One commenter asked if a definition should be developed to describe
what is meant by a confirmatory creatinine and specific gravity test.
The DOT believes that the terms ``confirmatory creatinine test'' and
``confirmatory specific gravity test'' are self-explanatory and do not
need more specific definitions. A confirmatory specimen validity test
is just that, a test on a separate aliquot to confirm the results of an
initial specimen validity test.

Section 40.89 What is specimen validity testing, and are laboratories
required to conduct it?

    The DOT will make SVT mandatory by removing the option to conduct
SVT and adding text requiring SVT. This proposal had a majority of
favorable comments. Specific discussion of this item is listed under
Principal Policy Issues.

Section 40.95 What are the adulterant cutoff concentrations for initial
and confirmation tests?

Section 40.96 What criteria do laboratories use to establish that a
specimen is invalid?

    The DOT proposed adding two tables (one at the existing Sec.
40.95, the other at a new Sec.  40.96) to inform MROs and others about
the cutoffs and the procedures HHS directs laboratories to use in
reporting adulterated and invalid test results. We sought comments on
whether this information would be helpful to MROs and others, or would
have too much information and be too complicated to add value.
    Most commenters supported the proposal to include two tables
related to adulterant and invalid testing cutoffs. The DOT, however,
did not include these tables because we are concerned that including
such tables could provide information useful in developing adulterants
to circumvent the testing process. Moreover, the inclusion of these
tables would not clarify for laboratories what they are currently
required to report by the HHS Mandatory Guidelines nor would it add to
the effectiveness of the MRO verification process. Since the cutoff
levels are mandated by the HHS, duplicating them in the rule text does
not add any value or streamline the overall procedures required by part
40. Therefore, we have indicated in the rule text that laboratories
will be required to use cutoff levels for adulterated and

invalid urine specimens that are directed by the HHS.
    One commenter stated that an invalid report due to abnormal pH is
reported only as ``abnormal pH'' per HHS direction. For the MRO to find
out if it was abnormally high or low, the MRO must contact the
laboratory. The commenter suggested that DOT direct laboratories to
report either high pH or low pH or the actual pH numbers. This would be
consistent with Sec.  40.96(d) which directs laboratories to report the
reason a test is invalid and would remove the need for the MRO to call
the laboratory on these results.
    We agree with the comment that the use of the term abnormal pH
creates a requirement for the MRO to contact the laboratory, and we
will therefore, direct laboratories to report the actual numerical
value for pH.
    Finally, one commenter suggested that we clearly point out that the
confirmation test is one that uses a different chemical methodology
than the initial test on a second aliquot of the specimen. The
definition of ``confirmatory validity test'' clearly states that a
confirmation test is performed on a different aliquot of the original
specimen.

Section 40.97 What do laboratories report and how do they report it?

    Laboratories are reporting and MROs are reviewing a variety of test
results, including multiple test results for the same testing event.
The DOT proposed using categories to make it easier to understand what
laboratories and MROs are to report.
    Of the commenters who responded to this proposal, some addressed
only the question of categories, while others addressed issues related
to multiple reporting. Several commenters agreed that understanding the
myriad of results is a difficult situation and supported the DOT's
attempt to simplify it through the use of identifying categories.
    Some concerns centered on the complexities of reporting multiple
results of two separate collections from the same collection event.
These commenters were troubled about how the overall process would
work--for example, if two CCFs were produced on a collection, what
would the MRO do with them and how would the MRO report the results?
Additionally, the issue of cost per test to the employer was raised and
the difficulty of billing with no documentation (i.e., no CCF for the
test not reported). In any situation where the tests are reported
negative and non-negative--in any order of collection--commenters
agreed that the non-negative test should be the result of record
reported by the MRO for the testing event. These MRO issues are
addressed in the discussion of Sec.  40.162.
    Some commenters supported the use of categories and some did not. A
number believed that laboratories would not use the categories, but
would continue to use specific test results because these are more
descriptive and useful. A commenter felt that the terms ``negative''
and ``non-negative'' are very simple and descriptive and much more
useful than a category list.
    The DOT never intended for laboratories to report results as
``Category 1'' or ``Category 2'' or ``Category 3.'' In the NPRM, we
merely said that a laboratory's specimen testing result would fall into
one of three distinct and separate categories--negative; non-negative;
and rejected for testing--and we described them as Categories 1 through
3. We agree with those commenters who said this delineation made it
easier for them to understand that the results reported would fall into
one of those three categories. Therefore, we will keep the three
separate categories for results being reported with the understanding
that laboratories are not to report a result as being in a specific
category (i.e., Category 1, Category 2, or Category 3; or non-
negative), but must report a specific result.

Section 40.133 Under what circumstances may the MRO verify a test
result as positive, or as a refusal to test because of adulteration or
substitution, or as cancelled because the specimen was invalid, without
interviewing the employee?

    MROs have situations in which neither they nor the employers are
able to contact employees to complete the interview process for invalid
results. The DOT proposed to modify Sec.  40.133 so that invalids would
be handled parallel to part 40's directives on positive, adulterated,
and substituted specimens when the employee cannot be interviewed. Four
commenters responded to this proposal, and all supported the proposed
procedure for resolving invalid test results without interviewing the
employee. Based on the comments, the DOT will adopt the proposal in
Sec.  40.133 with one modification: To refer to this result as a
cancelled test due to an invalid result, instead of a cancelled-
invalid.

Section 40.159 What does the MRO do when a drug test is invalid?

    The DOT made a number of proposals trying to close the potential
endless loop of observed collections that could result when the
specimen result of a directly observed recollection, following a first
invalid (and in some cases, a second or third observed collection), is
again invalid.
    If the second invalid result was for the same reason as the first
invalid, we proposed having the MRO cancel the test. One commenter
wished to call this a negative test. The DOT believes it would be
inappropriate for the MRO to call this a negative test. Therefore, we
will have the MRO cancel the test if the observed recollection is
invalid for the same reason as the first invalid. This is consistent
with the HHS guidance to MROs. In addition, in Sec.  40.160 (see
below), we have provided a way for MROs to obtain negative results for
invalids when employees require negative results for pre-employment,
return-to-duty, and follow-up testing.
    If the second invalid result was for a different reason than the
first invalid, the DOT proposed having the MRO verify the result as a
refusal to test. We did this to harmonize with the HHS guidance to
MROs. We also proposed adding this to the list of refusals at Sec.
40.191.
    Many of the commenters said that calling this an automatic refusal
to test is problematic--especially if this were allowed without MRO
review. The DOT agrees with these commenters. We have decided not to
adopt the proposal to add this to the list of refusals at Sec.  40.191.
We will consider this an invalid result requiring another immediate
recollection under direct observation--and we will not require the MRO
to first contact the employee to discuss the result.
    The DOT also proposed that when the MRO reports multiple non-
negative results and one of them is invalid, the MRO would not be
required to report an ``invalid result'' if the MRO verified any of the
other non-negative results--for example, a positive result. A number of
commenters supported this proposal, but one did not understand what DOT
wanted the MRO to do about the invalid result.
    The DOT believes that Sec.  40.159(f) is clear: When the MRO
verifies multiple non-negative results and one of them is invalid, the
MRO would report all but the invalid result. The invalid result simply
will not be reported and the test would not be cancelled because there
would actually be at least one reportable non-negative result. For
instance, if a laboratory reported a test result as being positive for
phencyclidine (PCP) and invalid, the MRO would conduct an MRO review
for both the PCP positive and the invalid. The MRO would verify the PCP
positive and report it to the employer. Even if the employee had no

medical explanation for the invalid result, the MRO would not report it
to the employer unless the employee requests to have his or her split
specimen tested for PCP and the split fails to reconfirm. The MRO would
then cancel both tests, report them to the DER, and direct an immediate
recollection under direct observation because the primary specimen had
also been invalid. The same would hold true for invalid specimens whose
splits failed to reconfirm for adulterants and substitutions.
    We also proposed to have MROs contact collection sites to confirm
that collectors had properly observed the collections. We agree with
the majority of commenters who said that having MROs confirm that
collections had been directly observed is labor intensive and of little
value, especially if CCFs indicate that observed collections were
conducted. Therefore, we will not require the MRO to contact the
collector.
    Finally, if the employee admits to using drugs to the MRO during
the invalid result interview, the MRO must report the admission to the
DER for additional action under applicable DOT Agency and United States
Coast Guard regulations.

Section 40.160 What does the MRO do when a valid test result cannot be
produced and a negative result is required?

    The DOT proposed adding a new Sec.  40.160 to address procedures
when a negative result is required but a valid test result cannot be
produced because of an individual's legitimate, albeit rare, medical
condition.
    In such rare circumstances, we will require the MRO to determine if
there is clinical evidence that the individual is an illicit drug user.
The evaluation requirements in this section will be parallel to
existing requirements at Sec.  40.195--when a permanent or long-term
medical condition precludes the employee from providing a sufficient
amount of urine and a negative result is needed. If the medical
evaluation reveals no clinical evidence of drug use, the MRO would
report the result to the employer as a negative test with written
notations regarding the medical examination. The same procedures would
be used when the primary specimen is reported as invalid and the
individual has a legitimate medical explanation.
    The DOT also requested comments about findings of illicit drug use
during these medical evaluations. Currently, a finding of illicit drug
use during the medical evaluation under Sec.  40.195 causes the test to
be cancelled. We asked for comments on whether the DOT should continue
to require cancellation or treat such findings as positive test
results.
    Most commenters stated that findings of illicit drug use during the
medical evaluation should be considered a positive result. Two
commenters felt they should be reported as a refusal. One commenter
stated that if the examination discloses evidence of current illicit
drug use, this should be reported as a positive result. Another
commenter was concerned that this evaluation may identify past drug use
and may not provide the employee with due process. One commenter stated
that a blood test would be far superior to a medical examination in
determining evidence of substance abuse.
    Although a number of these commenters believe that a finding of
illegal drug use during the medical evaluation should be considered a
positive or a refusal, the DOT will require that in these cases, MROs
will cancel the test, parallel to the existing procedures for
insufficient urine in Sec.  40.195. The Omnibus Transportation
Employees Testing Act of 1991 provides only one way to determine that
an employee has tested positive for illicit drug use--a drug test
confirmed by an HHS-certified laboratory using HHS scientific and
testing protocols and verified by an MRO. Therefore, we will continue
to cancel these results if there are medical signs and symptoms of
illicit drug use. The individual will not be able to perform safety-
sensitive duties because a negative result is needed. The MROs, under
their authority at Sec.  40.327, must continue to report safety and
medical qualification concerns to appropriate parties, such as the
employer and the physician or health care provider responsible for
determining medical qualifications of the employee.
    In response to the commenter who thought a blood test far superior
to a medical examination for determining substance abuse, we would
remind everyone that as part of this medical evaluation, the evaluating
physician may conduct other testing to determine whether the employee
shows clinical evidence of drug abuse, including, but not limited to,
blood testing.

Section 40.162 What must MROs do with multiple verified results for the
same testing event?

    The DOT requested comments to proposed procedures addressing how
the MRO would report multiple verified results from one testing event--
either multiple results from a single specimen or multiple results from
more than one specimen collected during one event. Regarding multiple
results from more than one specimen, we asked if it was sensible to
require collectors to continue to send two separate specimen
collections (e.g., a specimen that showed signs of tampering and the
subsequent observed collection) to laboratories. In other words, should
we continue requiring collectors to send the observed collection but
not the specimen that appeared to show signs of tampering?
    Most commenters appreciated the fact that DOT had articulated what
MROs are to report after verifying multiple results for the same
testing event. Some commenters correctly noted some of the problems
associated with multiple specimens collected during the same testing
event. For example, these multiple specimens pose administrative
difficulties: Tying together two collections and two laboratory results
and simultaneously reporting the two verified results. In addition,
some commenters noted that testing a second specimen imposes additional
cost. None of the comments included credible evidence to show that the
results of the observed collections were always non-negative.
    Therefore, we will continue to require that collectors send both
the specimen suspected of adulteration or substitution and the directly
observed specimen on for laboratory testing. At Sec.  40.67(f),
collectors are already directed to identify and link both specimens in
the Remarks section of the CCFs. When the collector follows the
required procedures, and the MRO reviews the MRO copies of CCFs before
reporting results, the MRO will know that the specimen appeared to show
signs of tampering and that specimen is connected to another specimen
taken under direct observation. MROs should have procedures in place to
identify and connect these linked specimens.
    We will modify the section to authorize MROs to ``hold'' the result
of the first laboratory specimen result received if it is negative
until the MRO receives the result of a second specimen. If the first
result is non-negative, the MRO reports it immediately. The MRO would
then follow the required reporting procedures.

Section 40.171 How does an employee request a test of a split specimen?

    The DOT proposed amending Sec.  40.171 to state clearly that there
is no split specimen testing for an invalid result. This is consistent
with current part 40 split request procedures and with the

HHS MRO Manual. Most commenters who responded to this item supported
it. We will retain it as written in the NPRM.

Section 40.177 What does the second laboratory do with the split
specimen when it is tested to reconfirm the presence of a drug or drug
metabolite?

 Section 40.179 What does the second laboratory do with the split
specimen when it is tested to reconfirm an adulterated test result?

Section 40.181 What does the second laboratory do with the split
specimen when it is tested to reconfirm a substituted test result?

    These sections concern the DOT's decision to provide authorization
for the split laboratory to send the split specimen or an aliquot of it
to another HHS-certified laboratory if the split fails to reconfirm the
primary specimen's results. The DOT proposed amending Sec. Sec.
40.177, 40.179, and 40.181 so that a provision currently contained only
in Sec.  40.177 for drug testing would be added to the adulterated and
substituted split sections. The DOT sought comment on whether providing
authorization to the split laboratory would be sufficient, or whether
we should require laboratories to send the split specimen or an
aliquot.
    Several commenters opposed making it mandatory to send the specimen
to another laboratory but believed that providing authorization to do
so would be sufficient. One commenter wondered if the term ``you may''
send a specimen to a third laboratory would become ``routine'' practice
and something that all laboratories would then do. This commenter
recommended that Laboratory B send the split to a third laboratory only
under special circumstances that are documented and have been discussed
with the MRO.
    The DOT has amended Sec. Sec.  40.177, 40.179, and 40.181. We
continue to authorize the split laboratory to send the split specimen
or an aliquot of it to another HHS-certified laboratory to reconfirm
the presence of drugs/drug metabolites. We also authorize the same for
adulterated specimens. Because the testing procedures for identifying
substituted specimens are the same at each laboratory, there would be
no reason to send the split to a third laboratory if it failed to
reconfirm at a second laboratory.
    We will not require a discussion between the MRO and laboratory.
The longstanding requirements at Sec.  40.177 on sending the split
specimen to another laboratory, which did not make MRO discussion with
the laboratory mandatory, have not appeared to cause problems. We agree
with the commenter who said that sending split specimens to a third
laboratory should not be routine. Therefore, a split specimen should
only be sent to a second laboratory when it is likely that doing so
will confirm the criteria that were reported in the primary specimen.
    Several commenters asked for clarification of Sec.  40.181(b),
which stated, ``if the test fails to reconfirm the validity criteria
reported in the primary specimen, the second laboratory may transmit
the specimen or an aliquot to another HHS-certified laboratory that has
the capability to conduct another reconfirmation test.'' These
commenters asked whether ``another reconfirmation test'' is a
requirement to conduct a different, more specific, test method.
    With regard to the language proposed in the NPRM at 40.181(b), we
are removing the paragraph because all laboratories use the same
confirmation methodologies for creatinine and specific gravity.
    We intend Sec.  40.179(b) to provide an option for using another
laboratory to make it more likely to reconfirm the adulterated criteria
reported for the primary specimen. In writing Sec.  40.179(b), we used
the language currently at Sec.  40.177 that addresses the use of
another laboratory to confirm the split specimen. We are retaining the
word ``another'' in Sec.  40.179(b), to require the second split
laboratory to use a different confirmation test than the one used by
the first split laboratory. In the case of pH, all laboratories use the
same test methodologies, so this would not apply to pH. However, for
other adulterants, we think another confirmation test would be suitable
if it is likely to confirm the adulteration criteria reported in the
primary specimen. If the first split laboratory is unable to confirm
the adulteration criteria of the specimen, a second split laboratory,
using a different confirmation procedure, may be able to confirm the
test result. Therefore, the DOT will retain most of the specific
language proposed in the NPRM at Sec.  40.179(b).

Section 40.187 What does the MRO do with split specimen laboratory
results?

    The DOT proposed to divide the split results into five distinct
categories to make it easier for MROs to understand their
responsibilities in cases where they receive any of the more
complicated split result possibilities. The majority of commenters
supported this proposal. One commenter suggested that these categories
would lend themselves to a table.
    The DOT will retain the five categories of split results as
proposed in the NPRM. We will not include a table, since the
description of the five categories in the rule text is specific and
self-explanatory.

Section 40.197 What happens when an employer receives a report of a
dilute specimen?

    The DOT did not propose any changes to the employer policy
providing the option for recollection of negative-dilute specimens at
Sec.  40.197(b)(2), although we added additional rule text to clarify
procedures. Several commenters supported this. One commenter suggested
that the rules for dilute specimens should be more rigorous. Another
commenter suggested that if the DOT believes it appropriate to
recollect a negative dilute, the DOT should require that all results of
this type be recollected without giving the employer a choice in the
matter.
    The DOT will not make any changes in this area, other than to
revise paragraph Sec.  40.197(c)(3), re-designate paragraph (c)(4) as
(c)(5), and add paragraph (c)(4). Negative specimens that are also
dilute will continue to be viewed as negative specimens, but with the
option for employer policies to determine if there is to be a
recollection. This is in keeping with the current regulation for which
there have been no significant issues raised.

Section 40.201 What problems always cause a drug test to be cancelled
and may result in a requirement for another collection?

    The DOT proposed changes for splits that are reported as invalid.
Commenters who responded to this item supported the proposed rule
language. We also proposed changes for a situation in which there is no
split laboratory available to test the split specimen. One commenter,
an MRO, supported this proposal. We will amend this section by revising
paragraphs (c), (d), and (e) and maintain the changes as proposed in
the NPRM.
    Section 40.207 This section was amended by changing the references
in the paragraph.

Appendices

Appendix B

    As proposed, the DOT will modify the semi-annual laboratory report
to employers so that it has the same information required by the HHS
Mandatory Guidelines. The three proposed changes, while not dramatic,
will help laboratories avoid following different report formats for DOT
and HHS.

Appendix C

    As discussed earlier, we will also add Appendix C requiring
laboratories to provide the Department semi-annual data about their
DOT-mandated testing.

Appendix D

    We will also modify Appendix D to show DOT's new mailing address
and electronic-entry address.

Appendix F

    DOT will also amend some Appendix F citations to accurately reflect
text changes.

Comments Related to Other NPRM Issues and Questions

    The DOT asked a number of other questions related to several
issues. Most of these have been addressed in other portions of the
preamble. The following issues were not addressed and are discussed
below:
    We wanted to know if it would be appropriate to require that
observers check for realistic-looking prosthetic devices by having
employees lower their pants and underwear just before observed
collections take place.
    Most commenters did not support this proposal on the basis that it
was too invasive and that most observers can be trained in ensuring
that the urine specimen actually comes from the individual. One
commenter indicated that if there is any suspicion during collection,
one method that could be used was a one-handed collection (for males)
since most devices have a valve that needs to be released and this
cannot be done if the donor is holding the collection cup in one hand
(with the other hand behind his back).
    One association said this proposal would be totally inappropriate
since most of their members are female. One TPA and one MRO stated that
checks for prosthetic devices should be allowed, but not mandatory,
since trained collectors should be expected to know when these checks
are needed. Another association supported this proposal and indicated
that the Olympic model could be used, where the donors raise their
shirts to the chest line and lower their underwear to the knees for
initial inspections.
    We are also aware that the Omnibus Employee Testing Act of 1991
directed the DOT to utilize procedures that ``promoted, to the maximum
extent practicable, individual privacy in the collection of specimen
samples.'' We believe that, with the current proliferation of
adulteration products, checking for devices prior to observed
collections provide individual privacy ``to the maximum extent
practicable.'' In the early 1990's, adulteration was not a significant
problem and the current wide variety of products for adulteration of
urine were not available. However, because these products and various
mechanical devices are now readily available to individuals who want to
adulterate or substitute their urine specimen during a drug testing
collection, we believe that the measure of what is the maximum extent
of privacy has shifted somewhat. Checking for devices prior to observed
collections is the most effective way to ensure the integrity of the
testing process while providing individual privacy as much as
practicable.
    We would also point out that employees who may be required to
undergo a directly observed collection have provided reasons to
necessitate this procedure by providing specimens that: Showed signs of
tampering; were invalid with no legitimate medical explanation for the
result; or demonstrated a negative and dilute specimen with creatinine
concentration in the 2 to 5 mg/dL range, which made the specimen
suspect of adulteration or tampering. Some of these employees may have
already violated the testing regulations and are having a return-to-
duty or follow-up test.
    Based on these facts, the DOT will require employees who are
undergoing directly observed collections to raise their shirts,
blouses, or dresses/skirts, as appropriate, above the waist and lower
their pants and underpants to show the observer, by turning around,
that they do not have a prosthetic device on their person. After this
is done, they may return their clothing to its proper position and
contribute a specimen in such manner that the observer can see the
urine exiting directly from the individual into the collection
container, as required under current regulations. We will also require
direct observation collections for all return-to-duty and follow-up
drug tests. We are amending Sec.  40.67 to reflect this procedure and
this requirement for return-to-duty and follow-up drug tests.
    We also asked for comments regarding the consequence when a
realistic-looking prosthetic device is found.
    Eight commenters responded. Seven commenters indicated that this
should definitely be treated as a refusal to test. One association
stated that this should be considered on a case-by-case basis and that
the collector should request the donor to remove the device and then
proceed with the collection. If the donor fails to remove the device,
the collector should document this as a refusal to test.
    The DOT agrees with the majority of commenters that the use of
realistic-looking prosthetic devices to circumvent the urine specimen
collection process is a significant and grievous action, in most cases
related to an individual attempting to hide drug use; and it is a
deliberate attempt to thwart the testing process. We believe that this
action is no different than an individual refusing to cooperate or
participate in a specimen collection process. The end result of failure
to cooperate is a refusal to test. We believe trying to subvert the
collection process using a prosthetic device is as serious an offense
and will consider this as a refusal to test. We said so in the July
2006 Questions and Answers guidance; and we will add it to the list in
Section 40.191 as constituting a refusing to test.
    Also, in the July 2006 Questions and Answers that appear on our Web
site, we added to the examples of refusals to test at the collection
site an individual refusing to wash his or her hands and an individual
admitting to adulterating or substituting a specimen. We will add these
two examples to the list in Section 40.191 as constituting a refusal to
test. In addition, we will add an employee's refusal to allow the
observer to check for devices prior to undergoing an observed
collection.

Editorial Comments

    There were 17 comments (some duplicates) that addressed editorial
changes and included typographical errors. We appreciate these comments
and included most of them.

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).

Executive Order 12866

    This rule has been designated as significant by the Office of
Management and Budget for purposes of Executive Order 12866 or the
DOT's regulatory policies and procedures, because of potential policy
interest to Congress, affected industries, and the public. It is a
modification to our overall part 40 procedures and is intended to
further align our laboratory and MRO procedures with those requirements
that are being directed by HHS. Their economic effects will be very
small. Consequently, the DOT certifies, under the Regulatory
Flexibility Act, that this rule will not have a significant

economic impact on a substantial number of small entities.
    In the 2000 part 40 final rule, we estimated that approximately 80%
of industry specimens were being tested for SVT and that the costs
associated with making SVT mandatory would be about $1.4 million
annually--for the 20% that we estimated were not being tested. One
commenter misinterpreted our data, thinking that the cost was for
testing of the current 80%, and asked for clarification of how the DOT
arrived at these figures. Another commenter questioned the accuracy of
our more current information, pointing out that at the time the NPRM
was published, complete data for 2005 were not available.
    The HHS laboratory data for 2006 are available and show the actual
number of Federal tests performed was 7.54 million--7.32 million of
which were DOT tests. An estimated 98 to 99% of these DOT tests were
tested for SVT. The number of tests not being tested for SVT in 2006 is
estimated to be 200,000.
    A review of laboratory costs for SVT from a number of HHS-certified
laboratories indicated an average additional cost of 75 cents to $1.25
per specimen. Using the 2006 data, the cost of SVT would then only
increase the cost of DOT-mandated testing by about $200,000. This
figure is far less than the $1.4 million amount estimated and approved
for SVT in the 2000 final rule. Information on SVT from the DOT Federal
employee drug testing program and from another Federal agency's program
revealed that they experienced no increased laboratory costs for drug
testing when they implemented SVT.
    The DOT believes that $200,000 is a reasonable cost for the
mandatory SVT and should have minimal impact on employers. In fact, it
is far less than the 2000 final rule estimate for mandatory SVT.

Executive Order 12372 (Intergovernmental Review)

    Executive Order 12372 requires intergovernmental consultation with
state and local officials that would provide the non-Federal funds for,
or that would be directly affected by, proposed Federal financial
assistance or direct Federal development. The rule would not affect
state and local entities in a way that would warrant such consultation.

Unfunded Mandates Reform Act of 1995

    This rule would not impose unfunded mandates as defined by the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995,
109 Stat. 48). This rule will not result in the expenditure by State,
local, and tribal governments, in the aggregate, or by the private
sector, of $100 million or more in any one year (2 U.S.C. Sec.  1532).

Executive Order 13132 (Federalism)

    This rule has been analyzed in accordance with the principles and
criteria contained in Executive Order 13132 (``Federalism''). This
notice does not include requirements that (1) has substantial direct
effects on the States, the relationship between the national government
and the States, or the distribution of power and responsibilities among
the various levels of government, (2) imposes substantial direct
compliance costs on State and local governments, or (3) preempts state
law. Therefore, the consultation and funding requirements of Executive
Order 13132 do not apply.

Executive Order 13084

    This rule has been analyzed in accordance with the principles and
criteria contained in Executive Order 13084 (``Consultation and
Coordination with Indian Tribal Governments''). Because none of the
provisions of the rule would significantly or uniquely affect the
communities of the Indian tribal governments or impose substantial
direct compliance costs on them, the funding and consultation
requirements of Executive Order 13084 do not apply.

Paperwork Reduction Act

    DOT invites public comment about our intention to request the
Office of Management and Budget's (OMB) approval for a new information
collection, which is summarized below. We will subsequently publish a
Federal Register notice concerning this proposed collection. We would
add a requirement that all HHS-certified laboratories provide testing
data to the DOT on a semi-annual basis. This is data readily available
in laboratory computer systems--information they provide routinely to
HHS. They provide similar company-specific information to employers on
a semi-annual basis. We estimate that these semi-annual reports to DOT
will take a total of six hours for all the laboratories to complete, at
a cost of approximately $162 to all laboratories, or less than $4
annually for each laboratory.

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.

    Dated: June 11, 2008.
Mary E. Peters,
Secretary of Transportation.

49 CFR Subtitle A--Authority and Issuance

0
For reasons discussed in the preamble, the Department of Transportation
is amending part 40 of Title 49 Code of Federal Regulations, as
follows:

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

0
1-2. 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.

0
3. Section 40.3 is amended by revising the definitions of ``adulterated
specimen,'' ``confirmation (or confirmatory) drug test,''
``confirmation (or confirmatory) validity test,'' ``dilute specimen,''
``initial drug test,'' ``initial validity test,'' ``invalid result,''
and ``substituted specimen'' and adding definitions for ``aliquot,''
``limit of detection,'' ``non-negative specimen,'' ``oxidizing
adulterant,'' and ``screening test'' in alphabetical order, all to read
as follows:

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

* * * * *
    Adulterated specimen. A urine specimen containing a substance that
is not a normal constituent or containing an endogenous substance at a
concentration that is not a normal physiological concentration.
* * * * *
    Aliquot. A fractional part of a specimen used for testing. It is
taken as a sample representing the whole specimen.
* * * * *
    Confirmatory drug test. A second analytical procedure to identify
the presence of a specific drug or metabolite which is independent of
the initial test and which uses a different technique and chemical
principle from that of the initial test in order to ensure reliability
and accuracy. (Gas chromatography/mass spectrometry (GC/MS) is the only
authorized confirmation method for cocaine, marijuana, opiates,
amphetamines, and phencyclidine).
    Confirmatory validity test. A second test performed on a different
aliquot of the original urine specimen to further support a validity
test result.
* * * * *

    Dilute specimen. A urine specimen with creatinine and specific
gravity values that are lower than expected for human urine.
* * * * *
    Initial drug test (also known as a Screening drug test). An
immunoassay test to eliminate ``negative'' urine specimens from further
consideration and to identify the presumptively positive specimens that
require confirmation or further testing.
    Initial validity test. The first test used to determine if a urine
specimen is adulterated, diluted, or substituted.
    Invalid result. The result reported by a laboratory for a urine
specimen that contains an unidentified adulterant, contains an
unidentified interfering substance, has an abnormal physical
characteristic, or has an endogenous substance at an abnormal
concentration that prevents the laboratory from completing testing or
obtaining a valid drug test result.
* * * * *
    Limit of Detection (LOD). The lowest concentration at which an
analyte can be reliably shown to be present under defined conditions.
* * * * *
    Non-negative specimen. A urine specimen that is reported as
adulterated, substituted, positive (for drug(s) or drug metabolite(s)),
and/or invalid.
* * * * *
    Oxidizing adulterant. A substance that acts alone or in combination
with other substances to oxidize drugs or drug metabolites to prevent
the detection of the drug or drug metabolites, or affects the reagents
in either the initial or confirmatory drug test.
* * * * *
    Screening drug test. See Initial drug test definition above.
* * * * *
    Substituted specimen. A urine specimen with creatinine and specific
gravity values that are so diminished or so divergent that they are not
consistent with normal human urine.
* * * * *

0
4. Section 40.23 is amended by revising paragraph (f) introductory text
and adding paragraph (f)(5), to read as follows:

Sec.  40.23  What actions do employers take after receiving verified
test results?

* * * * *
    (f) As an employer who receives a drug test result indicating that
the employee's urine specimen test was cancelled because it was invalid
and that a second collection must take place under direct observation--
* * * * *
    (5) You must ensure that the collector conducts the collection
under direct observation.
* * * * *

0
5. Section 40.67 is amended by revising paragraph b); redesignating
paragraphs (i), (j), (k), (l), and (m) as (j), (k), (l), (m), and (n)
respectively, and adding a new paragraph (i) to read as follows:

Sec.  40.67  When and how is a directly observed collection conducted?

* * * * *
    (b) As an employer, you must direct a collection under direct
observation of an employee if the drug test is a return-to-duty test or
a follow-up test.
* * * * *
    (i) As the observer, you must request the employee to raise his or
her shirt, blouse, or dress/skirt, as appropriate, above the waist; and
lower clothing and underpants to show you, by turning around, that they
do not have a prosthetic device. After you have determined that the
employee does not have such a device, you may permit the employee to
return clothing to its proper position for observed urination.
* * * * *

0
6. Section 40.83 is amended by revising paragraph (g)(2) to read as
follows:

Sec.  40.83  How do laboratories process incoming specimens?

* * * * *
    (g) * * *
    (2) If the problem(s) is not corrected, you must reject the test
and report the result in accordance with Sec.  40.97(a)(3).
* * * * *

0
7-8. Section 40.89 is amended by revising paragraph (b) to read as
follows:

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

* * * * *
    (b) As a laboratory, you must conduct validity testing.

0
9. Section 40.95 is revised to read as follows:

Sec.  40.95  What are the adulterant cutoff concentrations for initial
and confirmation tests?

    (a) As a laboratory, you must use the cutoff concentrations for the
initial and confirmation adulterant testing as required by the HHS
Mandatory Guidelines and you must use two separate aliquots--one for
the initial test and another for the confirmation test.
    (b) As a laboratory, you must report results at or above the
cutoffs (or for pH, at or above or below the values, as appropriate) as
adulterated and provide the numerical value that supports the
adulterated result.

0
10. A new section 40.96 is added to read as follows:

Sec.  40.96  What criteria do laboratories use to establish that a
specimen is invalid?

    (a) As a laboratory, you must use the invalid test result criteria
for the initial and confirmation testing as required by the HHS
Mandatory Guidelines, and you must use two separate aliquots--one for
the initial test and another for the confirmation test.
    (b) As a laboratory, for a specimen having an invalid result for
one of the reasons outlined in the HHS Mandatory Guidelines, you must
contact the MRO to discuss whether sending the specimen to another HHS
certified laboratory for testing would be useful in being able to
report a positive or adulterated result.
    (c) As a laboratory, you must report invalid results in accordance
with the invalid test result criteria as required by the HHS Guidelines
and provide the numerical value that supports the invalid result, where
appropriate, such as pH.
    (d) As a laboratory, you must report the reason a test result is
invalid.
    11. Section 40.97 is amended by adding the words, ``and Rejected
for Testing'' between ``Non-negative'' and ``results'' in paragraph
(b)(2) and by revising paragraph (a) to read as follows:

Sec.  40.97  What do laboratories report and how do they report it?

    (a) As a laboratory, you must report the results for each primary
specimen. The result of a primary specimen will fall into one of the
following three categories. However, as a laboratory, you must report
the actual results (and not the categories):
    (1) Category 1: Negative Results. As a laboratory, when you find a
specimen to be negative, you must report the test result as being one
of the following, as appropriate:
    (i) Negative, or
    (ii) Negative-dilute, with numerical values for creatinine and
specific gravity.
    (2) Category 2: Non-negative Results. As a laboratory, when you
find a specimen to be non-negative, you must report the test result as
being one or more of the following, as appropriate:
    (i) Positive, with drug(s)/metabolite(s) noted;
    (ii) Positive-dilute, with drug(s)/ metabolite(s) noted, with
numerical values for creatinine and specific gravity;

    (iii) Adulterated, with adulterant(s) noted, with confirmatory test
values (when applicable), and with remark(s);
    (iv) Substituted, with confirmatory test values for creatinine and
specific gravity; or
    (v) Invalid result, with remark(s). Laboratories will report actual
values for pH results.
    (3) Category 3: Rejected for Testing. As a laboratory, when you
reject a specimen for testing, you must report the result as being
Rejected for Testing, with remark(s).
* * * * *

0
12. Section 40.103 is amended by removing the word ``blank'' and adding
in its place the word ``negative'' in paragraph (c) introductory text,
by revising paragraphs (c)(1) through (5), and removing paragraph
(c)(6) to read as follows:

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

* * * * *
    (c) * * *
    (1) All negative, positive, adulterated, and substituted blind
specimens you submit must be certified by the supplier and must have
supplier-provided expiration dates.
    (2) Negative specimens must be certified by immunoassay and GC/MS
to contain no drugs.
    (3) Drug positive blind specimens must be certified by immunoassay
and GC/MS to contain a drug(s)/ metabolite(s) between 1.5 and 2 times
the initial drug test cutoff concentration.
    (4) Adulterated blind specimens must be certified to be adulterated
with a specific adulterant using appropriate confirmatory validity
test(s).
    (5) Substituted blind specimens must be certified for creatinine
concentration and specific gravity to satisfy the criteria for a
substituted specimen using confirmatory creatinine and specific gravity
tests, respectively.
* * * * *

0
13. Section 40.105(c) is revised to read as follows:

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

* * * * *
    (c) If the unexpected result is a false positive, adulterated, or
substituted result, you must provide the laboratory with the expected
results (obtained from the supplier of the blind specimen), and direct
the laboratory to determine the reason for the discrepancy. You must
also notify ODAPC of the discrepancy by telephone<PHONE_NUMBER>) 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.

0
14. Section 40.111 is amended by adding a new paragraph (d) to read as
follows:

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

* * * * *
    (d) As a laboratory, 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.

0
15. Section 40.129 is amended by revising the section heading and
paragraph (a)(5) to read as follows:

Sec.  40.129  What are the MRO's functions in reviewing laboratory
confirmed non-negative drug test results?

    (a) * * *
    (5) Verify the test result, consistent with the requirements of
Sec. Sec.  40.135 through 40.145, 40.159, and 40.160, as:
    (i) Negative; or
    (ii) Cancelled; or
    (iii) Positive, and/or refusal to test because of adulteration or
substitution.
* * * * *

0
16. Section 40.131 is amended by revising the section heading to read
as follows:

Sec.  40.131  How does the MRO or DER notify an employee of the
verification process after receiving laboratory confirmed non-negative
drug test results?

* * * * *

0
17. Section 40.133 is amended by revising the section heading,
redesignating paragraphs (b) and (c) as (c) and (d), respectively,
revising them, and adding new paragraph (b) to read as follows:

Sec.  40.133  Without interviewing the employee, under what
circumstances may the MRO verify a test result as positive, or as a
refusal to test because of adulteration or substitution, or as
cancelled because the test was invalid?

* * * * *
    (b) As the MRO, you may verify an invalid test result as cancelled
(with instructions to recollect immediately under direct observation)
without interviewing the employee, as provided at Sec.  40.159:
    (1) If the employee expressly declines the opportunity to discuss
the test with you;
    (2) If the DER has successfully made and documented a contact with
the employee and instructed the employee to contact you and more than
72 hours have passed since the time the DER contacted the employee; or
    (3) If neither you nor the DER, after making and documenting all
reasonable efforts, has been able to contact the employee within ten
days of the date on which you received the confirmed invalid test
result from the laboratory.
    (c) As the MRO, after you verify a test result as a positive or as
a refusal to test under this section, you must document the date and
time and reason, following the instructions in Sec.  40.163. For a
cancelled test due to an invalid result under this section, you must
follow the instructions in Sec.  40.159(a)(5).
    (d) As the MRO, after you have verified a test result under this
section and reported the result to the DER, you must allow the employee
to present information to you within 60 days of the verification to
document that serious illness, injury, or other circumstances
unavoidably precluded contact with the MRO and/or DER in the times
provided. On the basis of such information, you may reopen the
verification, allowing the employee to present information concerning
whether there is a legitimate medical explanation of the confirmed test
result.

0
18. Section 40.149(a) introductory text and (a)(1) are revised to read
as follows:

Sec.  40.149  May the MRO change a verified drug test result?

    (a) As the MRO, you may change a verified test result only in the
following situations:
    (1) When you have reopened a verification that was done without an
interview with an employee (see Sec.  40.133(d)).
* * * * *

0
19. Section 40.155 is amended by adding paragraph (d) to read as
follows:

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

* * * * *
    (d) If the employee's recollection under direct observation, in
paragraph (c) of this section, results in another negative-dilute, as
the MRO, you must:
    (1) Review the CCF to ensure that there is documentation that the
recollection was directly observed.
    (2) If the CCF documentation shows that the recollection was
directly observed as required, report this result to the DER as a
negative-dilute result.
    (3) If CCF documentation indicates that the recollection was not
directly observed as required, do not report a result but again explain
to the DER that

there must be an immediate recollection under direct observation.

0
20. Section 40.159 is amended by revising paragraphs (a)(1) through
(3), adding paragraph (a)(4)(iii), and adding paragraphs (d) through
(g) to read as follows:

Sec.  40.159  What does the MRO do when a drug test is invalid?

    (a) * * *
    (1) Discuss the laboratory results with a certifying scientist to
determine if the primary specimen should be tested at another HHS
certified laboratory. If the laboratory did not contact you as required
by Sec. Sec.  40.91(e) and 40.96(c), you must contact the laboratory.
    (2) If you and the laboratory have determined that no further
testing is necessary, contact the employee and inform the employee that
the specimen was invalid. In contacting the employee, use the
procedures set forth in Sec.  40.131.
    (3) After explaining the limits of disclosure (see Sec. Sec.
40.135(d) and 40.327), you must determine if the employee has a medical
explanation for the invalid result. You must inquire about the
medications the employee may have taken.
    (4) * * *
    (iii) If a negative test result is required and the medical
explanation concerns a situation in which the employee has a permanent
or long-term medical condition that precludes him or her from providing
a valid specimen, as the MRO, you must follow the procedures outlined
at Sec.  40.160 for determining if there is clinical evidence that the
individual is an illicit drug user.
* * * * *
    (d) If the employee admits to using a drug, you must, on the same
day, write and sign your own statement of what the employee told you.
You must then report that admission to the DER for appropriate action
under DOT Agency regulations. This test will be reported as cancelled
with the reason noted.
    (e) If the employee's recollection (required at paragraph (a)(5) of
this section) results in another invalid result for the same reason as
reported for the first specimen, as the MRO, you must:
    (1) Review the CCF to ensure that there is documentation that the
recollection was directly observed.
    (2) If the CCF review indicates that the recollection was directly
observed as required, document that the employee had another specimen
with an invalid result for the same reason.
    (3) Follow the recording and reporting procedures at (a)(4)(i) and
(ii) of this section.
    (4) If a negative result is required (i.e., pre-employment, return-
to-duty, or follow-up tests), follow the procedures at Sec.  40.160 for
determining if there is clinical evidence that the individual is an
illicit drug user.
    (5) If the recollection was not directly observed as required, do
not report a result but again explain to the DER that there must be an
immediate recollection under direct observation.
    (f) If the employee's recollection (required at paragraph (a)(5) of
this section) results in another invalid result for a different reason
than that reported for the first specimen, as the MRO, you must:
    (1) Review the CCF to ensure that there is documentation that the
recollection was directly observed.
    (2) If the CCF review indicates that the recollection was directly
observed as required, document that the employee had another specimen
with an invalid result for a different reason.
    (3) As the MRO, you should not contact the employee to discuss the
result, but rather direct the DER to conduct an immediate recollection
under direct observation without prior notification to the employee.
    (4) If the CCF documentation indicates that the recollection was
not directly observed as required, do not report a result but again
explain to the DER that there must be an immediate recollection under
direct observation.
    (g) If, as the MRO, you receive a laboratory invalid result in
conjunction with a positive, adulterated, and/or substituted result and
you verify any of those results as being a positive and/or refusal to
test, you do not report the invalid result unless the split specimen
fails to reconfirm the result(s) of the primary specimen.
0
21. Section 40.160 is added to read as follows:

Sec.  40.160  What does the MRO do when a valid test result cannot be
produced and a negative result is required?

    (a) If a valid test result cannot be produced and a negative result
is required, (under Sec.  40.159 (a)(5)(iii) and (e)(4)), as the MRO,
you must determine if there is clinical evidence that the individual is
currently an illicit drug user. You must make this determination by
personally conducting, or causing to be conducted, a medical
evaluation. In addition, if appropriate, you may also consult with the
employee's physician to gather information you need to reach this
determination.
    (b) If you do not personally conduct the medical evaluation, as the
MRO, you must ensure that one is conducted by a licensed physician
acceptable to you.
    (c) For purposes of this section, the MRO or the physician
conducting the evaluation may conduct an alternative test (e.g., blood)
as part of the medically appropriate procedures in determining clinical
evidence of drug use.
    (d) If the medical evaluation reveals no clinical evidence of drug
use, as the MRO, you must report this to the employer as a negative
test result with written notations regarding the medical examination.
The report must also state why the medical examination was required
(i.e., either the basis for the determination that a permanent or long-
term medical condition exists or because the recollection under direct
observation resulted in another invalid result for the same reason, as
appropriate) and for the determination that no signs and symptoms of
drug use exist.
    (1) Check ``Negative'' (Step 6) on the CCF.
    (2) Sign and date the CCF.
    (e) If the medical evaluation reveals clinical evidence of drug
use, as the MRO, you must report the result to the employer as a
cancelled test with written notations regarding the results of the
medical examination. The report must also state why the medical
examination was required (i.e., either the basis for the determination
that a permanent or long-term medical condition exists or because the
recollection under direct observation resulted in another invalid
result for the same reason, as appropriate) and state the reason for
the determination that signs and symptoms of drug use exist. Because
this is a cancelled test, it does not serve the purpose of an actual
negative test result (i.e., the employer is not authorized to allow the
employee to begin or resume performing safety-sensitive functions,
because a negative test result is needed for that purpose).

0
22. Section 40.162 is added to read as follows:

Sec.  40.162  What must MROs do with multiple verified results for the
same testing event?

    (a) If the testing event is one in which there was one specimen
collection with multiple verified non-negative results, as the MRO, you
must report them all to the DER. For example, if you verified the
specimen as being positive for marijuana and cocaine and as being a
refusal to test because the specimen was also adulterated, as the MRO,
you should report the positives and the refusal to the DER.
    (b) If the testing event was one in which two separate specimen
collections (e.g., a specimen out of temperature range and the
subsequent observed collection) were sent to the laboratory, as the
MRO, you must:

    (1) If both specimens were verified negative, report the result as
negative.
    (2) If either of the specimens was verified negative and the other
was verified as one or more non-negative(s), report the non-negative
result(s) only. For example, if you verified one specimen as negative
and the other as a refusal to test because the second specimen was
substituted, as the MRO you should report only the refusal to the DER.
    (i) If the first specimen is reported as negative, but the result
of the second specimen has not been reported by the laboratory, as the
MRO, you should hold--not report--the result of the first specimen
until the result of the second specimen is received.
    (ii) If the first specimen is reported as non-negative, as the MRO,
you should report the result immediately and not wait to receive the
result of the second specimen.
    (3) If both specimens were verified non-negative, report all of the
non-negative results. For example, if you verified one specimen as
positive and the other as a refusal to test because the specimen was
adulterated, as the MRO, you should report the positive and the refusal
results to the DER.
    (c) As an exception to paragraphs (a) and (b) of this section, as
the MRO, you must follow procedures at Sec.  40.159(f) when any
verified non-negative result is also invalid.

0
23. Section 40.171 is amended by revising paragraph (a) to read as
follows:

Sec.  40.171  How does an employee request a test of a split specimen?

    (a) As an employee, when the MRO has notified you that you have a
verified positive drug test and/or refusal to test because of
adulteration or substitution, you have 72 hours from the time of
notification to request a test of the split specimen. The request may
be verbal or in writing. If you make this request to the MRO within 72
hours, you trigger the requirements of this section for a test of the
split specimen. There is no split specimen testing for an invalid
result.
* * * * *

0
24. Section 40.177 is amended by revising paragraph (d) to read as
follows:

Sec.  40.177  What does the second laboratory do with the split
specimen when it is tested to reconfirm the presence of a drug or drug
metabolite?

* * * * *
    (d) In addition, if the test fails to reconfirm the presence of the
drug(s)/ drug metabolite(s) reported in the primary specimen, you may
send the specimen or an aliquot of it for testing at another HHS-
certified laboratory that has the capability to conduct another
reconfirmation test.

0
25. Section 40.179 is revised to read as follows:

Sec.  40.179  What does the second laboratory do with the split
specimen when it is tested to reconfirm an adulterated test result?

    (a) As the laboratory testing the split specimen, you must test the
split specimen for the adulterant detected in the primary specimen,
using the confirmatory test for the adulterant and using criteria in
Sec.  40.95 and confirmatory cutoff levels required by the HHS
Mandatory Guidelines.
    (b) In addition, if the test fails to reconfirm the adulterant
result reported in the primary specimen, you may send the specimen or
an aliquot of it for testing at another HHS-certified laboratory that
has the capability to conduct another reconfirmation test.

0
26. Section 40.181 is revised to read as follows:

Sec.  40.181  What does the second laboratory do with the split
specimen when it is tested to reconfirm a substituted test result?

    As the laboratory testing the split specimen, you must test the
split specimen using the confirmatory tests for creatinine and specific
gravity, and using the confirmatory criteria set forth in Sec.
40.93(b).

0
27. Section 40.183 amended by revising paragraph (a), removing
paragraph (b), and re-designating paragraph (c) as paragraph (b).

Sec.  40.183  What information do laboratories report to MROs regarding
split specimen results?

    (a) As the laboratory responsible for testing the split specimen,
you must report split specimen test results by checking the
``Reconfirmed'' box and/or the ``Failed to Reconfirm'' box (Step 5(b))
on Copy 1 of the CCF, as appropriate, and by providing clarifying
remarks using current HHS Mandatory Guidelines requirements.
* * * * *

0
28. Section 40.187 is revised to read as follows:

Sec.  40.187  What does the MRO do with split specimen laboratory
results?

    As the MRO, the split specimen laboratory results you receive will
fall into five categories. You must take the following action, as
appropriate, when a laboratory reports split specimen results to you.
    (a) Category 1: The laboratory reconfirmed one or more of the
primary specimen results. As the MRO, you must report to the DER and
the employee the result(s) that was/were reconfirmed.
    (1) In the case of a reconfirmed positive test(s) for drug(s) or
drug metabolite(s), the positive is the final result.
    (2) In the case of a reconfirmed adulterated or substituted result,
the refusal to test is the final result.
    (3) In the case of a combination positive and refusal to test
results, the final result is both positive and refusal to test.
    (b) Category 2: The laboratory failed to reconfirm all of the
primary specimen results because, as appropriate, drug(s)/drug
metabolite(s) were not detected; adulteration criteria were not met;
and/or substitution criteria were not met. As the MRO, you must report
to the DER and the employee that the test must be cancelled.
    (1) As the MRO, you must inform ODAPC of the failure to reconfirm
using the format in Appendix D to this part.
    (2) In a case where the split failed to reconfirm because the
substitution criteria were not met and the split specimen creatinine
concentration was equal to or greater than 2mg/dL but less than or
equal to 5mg/dL, as the MRO, you must, in addition to step (b)(1) of
this paragraph, direct the DER to ensure the immediate collection of
another specimen from the employee under direct observation, with no
notice given to the employee of this collection requirement until
immediately before the collection.
    (3) In a case where the split failed to reconfirm and the primary
specimen's result was also invalid, direct the DER to ensure the
immediate collection of another specimen from the employee under direct
observation, with no notice given to the employee of this collection
requirement until immediately before the collection.
    (c) Category 3: The laboratory failed to reconfirm all of the
primary specimen results, and also reported that the split specimen was
invalid, adulterated, and/or substituted.
    (1) In the case where the laboratory failed to reconfirm all of the
primary specimen results and the split was reported as invalid, as the
MRO, you must:
    (i) Report to the DER and the employee that the test must be
cancelled and the reason for the cancellation.
    (ii) Direct the DER to ensure the immediate collection of another
specimen from the employee under direct observation, with no notice
given to the employee of this collection requirement until immediately
before the collection.

    (iii) Inform ODAPC of the failure to reconfirm using the format in
Appendix D to this part.
    (2) In the case where the laboratory failed to reconfirm any of the
primary specimen results, and the split was reported as adulterated
and/or substituted, as the MRO, you must:
    (i) Contact the employee and inform the employee that the
laboratory has determined that his or her split specimen is adulterated
and/or substituted, as appropriate.
    (ii) Follow the procedures of Sec.  40.145 to determine if there is
a legitimate medical explanation for the laboratory finding of
adulteration and/or substitution, as appropriate.
    (iii) If you determine that there is a legitimate medical
explanation for the adulterated and/or substituted test result, report
to the DER and the employee that the test must be cancelled; and inform
ODAPC of the failure to reconfirm using the format in Appendix D to
this part.
    (iv) If you determine that there is not a legitimate medical
explanation for the adulterated and/or substituted test result, you
must take the following steps:
    (A) Report the test to the DER and the employee as a verified
refusal to test. Inform the employee that he or she has 72 hours to
request a test of the primary specimen to determine if the adulterant
found in the split specimen is also present in the primary specimen
and/or to determine if the primary specimen meets appropriate
substitution criteria.
    (B) Except when the request is for a test of the primary specimen
and is being made to the laboratory that tested the primary specimen,
follow the procedures of Sec. Sec.  40.153, 40.171, 40.173, 40.179,
40.181, and 40.185, as appropriate.
    (C) As the laboratory that tests the primary specimen to reconfirm
the presence of the adulterant found in the split specimen and/or to
determine that the primary specimen meets appropriate substitution
criteria, report your result to the MRO on a photocopy (faxed, mailed,
scanned, couriered) of Copy 1 of the CCF.
    (D) If the test of the primary specimen reconfirms the adulteration
and/or substitution finding of the split specimen, as the MRO you must
report the result as a refusal to test as provided in paragraph (a)(2)
of this section.
    (E) If the test of the primary specimen fails to reconfirm the
adulteration and/or substitution finding of the split specimen, as the
MRO you must cancel the test, following procedures in paragraph (b) of
this section.
    (d) Category 4: The laboratory failed to reconfirm one or more but
not all of the primary specimen results, and also reported that the
split specimen was invalid, adulterated, and/or substituted. As the
MRO, in the case where the laboratory reconfirmed one or more of the
primary specimen result(s), you must follow procedures in paragraph (a)
of this section and:
    (1) Report that the split was also reported as being invalid,
adulterated, and/or substituted (as appropriate).
    (2) Inform the DER to take action only on the reconfirmed
result(s).
    (e) Category 5: The split specimen was not available for testing or
there was no split laboratory available to test the specimen. As the
MRO, you must:
    (1) Report to the DER and the employee that the test must be
cancelled and the reason for the cancellation;
    (2) Direct the DER to ensure the immediate recollection of another
specimen from the employee under direct observation, with no notice
given to the employee of this collection requirement until immediately
before the collection; and
    (3) Notify ODAPC of the failure to reconfirm using the format in
Appendix D to this part.
    (f) For all split specimen results, as the MRO you must:
    (1) Enter your name, sign, and date (Step 7) of Copy 2 of the CCF.
    (2) Send a legible copy of Copy 2 of the CCF (or a signed and dated
letter, see Sec.  40.163) to the employer and keep a copy for your
records. Transmit the document as provided in Sec.  40.167.

0
29. Section 40.191 is amended by revising paragraph (a)(8) and adding
paragraphs (a)(9), (10) and (11) to read as follows:

Sec.  40.191  What is a refusal to take a DOT drug test, and what are
the consequences?

    (a) * * *
    (8) Fail to cooperate with any part of the testing process (e.g.,
refuse to empty pockets when directed by the collector, behave in a
confrontational way that disrupts the collection process, fail to wash
hands after being directed to do so by the collector).
    (9) For an observed collection, fail to follow the observer's
instructions to raise your clothing above the waist, lower clothing and
underpants, and to turn around to permit the observer to determine if
you have any type of prosthetic or other device that could be used to
interfere with the collection process.
    (10) Possess or wear a prosthetic or other device that could be
used to interfere with the collection process.
    (11) Admit to the collector or MRO that you adulterated or
substituted the specimen.
* * * * *

0
30. Section 40.197 is amended by revising paragraph (c)(3),
redesignating paragraph (c)(4) as (c)(5), and adding new paragraph
(c)(4) to read as follows:

Sec.  40.197  What happens when an employer receives a report of a
dilute specimen?

* * * * *
    (c) * * *
    (3) If the result of the test you directed the employee to take
under paragraph (b)(1) of this section is also negative and dilute, you
are not permitted to make the employee take an additional test because
the result was dilute.
    (4) If the result of the test you directed the employee to take
under paragraph (b)(2) of this section is also negative and dilute, you
are not permitted to make the employee take an additional test because
the result was dilute. Provided, however, that if the MRO directs you
to conduct a recollection under direct observation under paragraph
(b)(1) of this section, you must immediately do so.
* * * * *

0
31. Section 40.201 is amended by revising paragraphs (c), (d), and (e)
to read as follows:

Sec.  40.201  What problems always cause a drug test to be cancelled
and may result in a requirement for another collection?

* * * * *
    (c) The laboratory reports that the split specimen failed to
reconfirm all of the primary specimen results because the drug(s)/drug
metabolite(s) were not detected; adulteration criteria were not met;
and/or substitution criteria were not met. You must follow the
applicable procedures in Sec.  40.187(b)--no recollection is required
in this case, unless the split specimen creatinine concentration for a
substituted primary specimen was greater than or equal to 2mg/dL but
less than or equal to 5mg/ dL, or the primary specimen had an invalid
result which was not reported to the DER. Both these cases require
recollection under direct observation.
    (d) The laboratory reports that the split specimen failed to
reconfirm all of the primary specimen results, and that the split
specimen was invalid. You must follow the procedures in Sec.
40.187(c)(1)--recollection under direct observation is required in this
case.
    (e) The laboratory reports that the split specimen failed to
reconfirm all of the primary specimen results because the split
specimen was not available for testing or there was no split laboratory
available to test the specimen. You must

follow the applicable procedures in Sec.  40.187(e)--recollection under
direct observation is required in this case.
* * * * *

Sec.  40.207  [Amended]

0
32. Section 40.207 is amended by removing, in paragraph (a)(3), the
reference to ``40.187(b)'' and adding in its place ``40.187(b)(2),
(c)(1), and (e)''.
0
33. Appendix B to Part 40 is revised to read as follows:

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

    The following items are required on each 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 Type of Test
(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)
5. Adulterated (number)
6. Substituted (number)
7. Invalid Result (number)

0
34. Appendix C to Part 40 is added to read as follows:

Appendix C to Part 40--DOT Drug Testing Semi-Annual Laboratory 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 report:
Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
1. DOT Specimen Results Reported (number)
2. Negative Results Reported (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)

0
35. Appendix D to Part 40 is revised to read as follows:

Appendix D to Part 40--Report Format: Split Specimen Failure To
Reconfirm

    Mail, fax, or submit electronically 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, Submit Electronically: http://www.dot.gov/ost/dapc/
mro_split.html.
    The following items are required on each report:
    1. MRO name, address, phone number, and fax number.
    2. Collection site name, address, and phone number.
    3. Date of collection.
    4. Specimen I.D. number.
    5. Laboratory accession number.
    6. Primary specimen laboratory name, address, and phone number.
    7. Date result reported or certified by primary laboratory.
    8. Split specimen laboratory name, address, and phone number.
    9. Date split specimen result reported or certified by split
specimen laboratory.
    10. Primary specimen results (e.g., name of drug, adulterant) in
the primary specimen.
    11. Reason for split specimen failure-to-reconfirm result (e.g.,
drug or adulterant not present, specimen invalid, split not
collected, insufficient volume).
    12. Actions taken by the MRO (e.g., notified employer of failure
to reconfirm and requirement for recollection).
    13. Additional information explaining the reason for
cancellation.
    14. Name of individual submitting the report (if not the MRO).

Appendix F to Part 40 [Amended]

0
36. Appendix F to Part 40 is amended by removing the references to
Sec.  40.187(a)-(f) and adding in its place Sec.  40.187(a) through
(e).

 [FR Doc. E8-14218 Filed 6-24-08; 8:45 am]

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