
[Federal Register: June 25, 2008 (Volume 73, Number 123)]
[Rules and Regulations]               
[Page 35961-35975]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn08-29]                         

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 (202) 366-3784 (voice), (202) 366-3897 (fax), or 
jim.swart@dot.gov (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

[[Page 35962]]

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

[[Page 35963]]

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

[[Page 35964]]

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

[[Page 35965]]

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

[[Page 35966]]

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

[[Page 35967]]

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.

[[Page 35968]]

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

[[Page 35969]]

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.
* * * * *

[[Page 35970]]

    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;

[[Page 35971]]

    (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 (202-366-3784) or e-
mail (addresses are listed on the ODAPC Web site, http://www.dot.gov/
ost/dapc). ODAPC will notify HHS who will take appropriate action.

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

[[Page 35972]]

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:

[[Page 35973]]

    (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.

[[Page 35974]]

    (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

[[Page 35975]]

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: (202) 366-3897, E-
mail: ODAPCWebMail@dot.gov.
    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]

BILLING CODE 4910-9X-P
