[Federal Register Volume 70, Number 209 (Monday, October 31, 2005)]
[Proposed Rules]
[Pages 62276-62288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21488]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-2003-15245]
RIN 2105-AD55


Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Transportation is proposing to amend certain 
provisions of its drug and alcohol testing procedures to change 
instructions to laboratories, medical review officers, and employers 
with respect to adulterated, substituted, diluted, and invalid specimen 
results. These proposed changes are intended to create consistency with 
specimen validity requirements established by the U.S. Department of 
Health and Human Services and to modify some measures taken in two of 
our own interim final rules. This NPRM also proposes to make specimen 
validity testing mandatory within the regulated transportation 
industries.

DATES: Comments to the notice of proposed rulemaking should be 
submitted by December 30, 2005. Late-filed comments will be considered 
to the extent practicable.

ADDRESSES: You may submit comments [identified by DOT DMS Docket Number 
15245] by any of the following methods:
    <bullet> Web Site: http://dms.dot.gov. Follow the instructions for 
submitting comments on the DOT electronic docket site.
    <bullet> Fax: 1-202-493-2251.
    <bullet> Mail: Docket Management Facility; U.S. Department of 
Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, 
Washington, DC 20590-0001.
    <bullet> Hand Delivery: Room PL-401 on the plaza level of the 
Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 am 
and 5 pm, Monday through Friday, except Federal Holidays.
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting 
comments.
    Instructions: All submissions must include the agency name and 
docket number or Regulatory Identification Number (RIN) for this 
rulemaking. For detailed instructions on submitting comments and 
additional information on the rulemaking process, see the Public 
Participation heading of the Supplementary Information section of this 
document. Note that all comments received will be posted without change 
to http://dms.dot.gov. including any personal information provided. 
Please see the Privacy Act heading under Regulatory Notices.
    Docket: For access to the docket to read background documents or 
comments received, go to http://dms.dot.gov at any time or to Room PL-
401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., 
Washington, DC, between 9 am and 5 pm, Monday through Friday, except 
Federal Holidays.

FOR FURTHER INFORMATION CONTACT: Jim L. Swart, Deputy Director (S-1), 
Office of Drug and Alcohol Policy and Compliance, 400 Seventh Street, 
SW., Washington, DC 20590; telephone number 202-366-3784 (voice), 202-
366-3897 (fax), or <a href="/cdn-cgi/l/email-protection#c5afaca8ebb6b2a4b7b185a1aab1eba2aab3"><span class="__cf_email__" data-cfemail="2f454642015c584e5d5b6f4b405b01484059">[email protected]</span></a> (e-mail).

SUPPLEMENTARY INFORMATION: 

Purpose

    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 U.S. 
Department of Health and Human Services (HHS) publishing its Mandatory 
Guidelines on SVT. In late 2001, the DOT amended part 40 [66 FR 41952, 
August 9, 2001] to remove the mandatory requirement because HHS had not 
finalized its Mandatory Guidelines regarding SVT. We said that SVT 
would remain authorized but not required.
    On April 13, 2004, HHS published a Federal Register notice revising 
its Mandatory Guidelines [69 FR 19644] with an effective date of 
November 1, 2004. Among the revisions contained in the HHS Mandatory 
Guidelines were the requirements that laboratories modify substituted 
specimen and diluted specimen testing and reporting criteria. HHS 
revised laboratory requirements for adulterated specimen testing. HHS 
also required each Federal agency to conduct specimen validity testing 
(SVT) to determine if urine specimens collected under HHS Federal 
Workplace Drug Testing Programs have been adulterated or substituted.
    In an interim final rule (IFR) [69 FR 64865] published on November 
9, 2004, the DOT changed a number of items in part 40 to make part 40 
and the HHS Mandatory Guidelines consistent. We did this to avoid 
conflicting requirements that implementation of both rules would have 
had on laboratories and medical review officers (MROs).
    In the 2004 IFR, we indicated that we intended to fully address all 
aspects of the HHS changes to their Mandatory Guidelines in a notice of 
proposed rulemaking (NPRM). We also indicated that we would also take 
into consideration any subsequent HHS handbook materials (e.g., HHS MRO 
Manual) and update our cost figures for SVT in the context of making 
SVT mandatory. In this NPRM, we have considered the HHS Guidelines as 
well as the HHS MRO Manual, we propose to make SVT mandatory, and we 
have updated our cost figures accordingly.
    In the 2004 IFR and an earlier IFR [68 FR 31626] from May 28, 2003, 
we solicited comments regarding SVT and substituted specimens. We will 
address the docket comments to both IFRs in this preamble.

Background

    We issued the 2003 IFR in order to respond 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 MROs would 
deal with any substituted result with creatinine concentration greater 
than or equal to 2 mg/dL. It did not change the HHS substitution 
criteria that we had used.
    In the 2004 IFR, we changed a number of items in part 40 to 
harmonize part 40 and the new HHS Mandatory Guidelines on SVT to avoid 
a number of inconsistent requirements that the

[[Page 62277]]

application of both rules would likely have created for 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 items upon which 
the 2004 IFR and the HHS Guidelines differed. The most important among 
them was the fact that SVT, though authorized by part 40 and the IFR, 
was not yet required.
    The 2000 part 40 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 part 40 to remove the 
mandatory requirement. This was because we believed it was advisable to 
wait until HHS completed its amendment before making SVT mandatory 
throughout the transportation industries for all DOT specimens. This 
NPRM proposes that SVT be made mandatory, as the DOT said it intended 
to do in its final rule of December 2000.

Principal Policy Issues

Harmonization With HHS

    In this NPRM we have sought to harmonize our SVT proposals for 
laboratories, MROs, and employers with the requirements contained in 
the HHS Mandatory Guidelines and the HHS Medical Review Officer Manual. 
Here are the most noteworthy of the coordinated proposals:
    1. We propose to make SVT mandatory--like it is now with the HHS 
Federal employee testing program.
    2. We would continue to utilize HHS instructions to laboratories 
for establishing and directing laboratory actions for SVT. We will also 
continue to look to HHS for establishing appropriate cutoffs. An HHS-
certified laboratory's testing equipment and SVT parameters are all 
HHS-driven. Our proposed tables related to adulterated and invalid 
laboratory results are primarily designed to explain and instruct HHS 
criteria rather than establish new criteria.
    3. We propose to modify some of our definitions and add a few new 
definitions in order to make them consistent with HHS Mandatory 
Guidelines definitions.
    4. We would continue to require laboratories to contact MROs when 
the laboratories find specific types of invalid results.
    5. Regarding multiple results actions and reporting for primary 
specimens, we would generally adopt HHS procedures both for 
laboratories and MROs. Uniquely to part 40, we propose ``categories'' 
of results in order to make it easier for MROs to understand what they 
are to do when verifying laboratory results and reporting their 
verified results.
    6. Regarding the numerous possible laboratory and MRO actions for 
split specimens, we would generally adopt HHS procedures both for 
laboratories and MROs. As with primary specimen results, we propose 
categories of split results designed to make it easier for MROs to 
verify and report results.
    7. We propose to clarify that split testing is still not offered 
for invalid results. The HHS MRO Manual makes this a clear point.
    8. We propose that if a second invalid result (collected under 
direct observation) occurs but for a different reason than the first 
invalid result, the verified result of the test event will be a 
refusal. This is also consistent with the HHS MRO Manual.
    9. We propose to adopt HHS blind specimen certification criteria.
    10. We propose to adopt HHS Semi-Annual Laboratory Report items.
    While we have sought to harmonize our requirements with those of 
HHS, there remain a few issues for which we have not proposed changes 
to procedures that were in the 2004 IFR or in part 40. Perhaps the most 
important one is that we have not proposed to modify the requirement 
that MROs treat laboratory reported negative-dilute results with 
creatinine levels greater than or equal to 2 mg/dL but less than or 
equal to 5 mg/dL (hereafter ``2-5mg/dL range'') as negative-dilutes 
that require immediate recollections under direct observation. We also 
have not proposed changes to the employer policy recollection option 
for other negative-dilutes. By contrast, HHS treats all negative-
dilutes in the same fashion--a Federal agency may collect the 
employee's specimen under direct observation during the employee's next 
scheduled test event.
    While we believe there are employees normally able to produce these 
2-5 mg/dL range negative-dilute specimen results, there are others who 
cannot produce them without tampering with their specimens. We are also 
aware of challenges an employer faces in tracking an employee's test 
selection in order to have the next collection directly observed, 
especially as time passes between testing events. Therefore, some 
negative-dilutes will continue to require recollection under direct 
observation while others may continue to follow the employer policy 
options of immediate recollections not under direct observation.
    There is also a difference between the HHS Mandatory Guidelines and 
this NPRM concerning how we intend to address an MRO's receiving a 
series of invalid test results from the same employee for the same 
testing event. If the employee presents two invalid results for the 
same reason or when the employee has a long-term medical condition that 
causes an invalid result, we propose a way to have MROs obtain a 
negative result if one is needed for pre-employment, return-to-duty, 
and follow-up testing. Also, we propose to have MROs deal with an 
invalid result when the specimen is also positive, substituted, and/or 
adulterated.
    For instance, the HHS MRO Manual directs MROs to report negative 
results if the initial invalid results and the subsequent directly 
observed results are invalid for the same reason. The DOT will continue 
to consider these to be cancelled tests because laboratories do not 
report invalid-negative results. If a negative result is needed because 
the testing event is pre-employment, return-to-duty, or follow-up, the 
NPRM proposes to have the MRO determine if there is clinical evidence 
that the employee is an illicit drug user. We propose the same clinical 
evidence determination if the employee has a long-term medical 
condition that causes the invalid result and needs a negative result. 
These clinical evidence evaluations are proposed to be identical to the 
evaluation currently required at Sec.  40.195 when an employee is 
unable to provide a sufficient amount of urine because of a permanent 
or long-term medical condition.
    Like HHS, we would have MROs follow review procedures, as 
appropriate, for all laboratory reported results and to report all 
verified results to employers. But unlike HHS, we propose having an 
exception that deals with MROs reporting multiple results when one of 
them is invalid. The NPRM would not require an MRO to report an invalid 
result if the MRO also verifies any other laboratory result for the 
specimen as positive and/or refusal to test. MROs have told us it is 
problematic for them to report cancelled-invalid tests in conjunction 
with positives or refusals. MROs and employers have questioned whether 
the required re-collection under direct observation needs to take 
place.
    We have not proposed adopting the HHS MRO Manual requirement that 
an MRO report a negative result if the medical explanation for a 
substituted specimen appears legitimate to the MRO. We believe that HHS 
has taken

[[Page 62278]]

ample measures to accurately identify substituted specimens by 
adjusting the creatinine concentration criteria laboratories need in 
order to report specimens as substituted. Part 40 will continue to have 
MROs report these verified results as cancelled, and report their 
determinations and basis for them to us. If the DOT begins to receive 
reports that MROs are canceling substituted specimen results because of 
legitimate medical reasons, we would be prepared to take measures 
needed for employees to obtain negative results (when negatives are 
needed for pre-employment, return-to-duty, and follow-up testing), 
perhaps by considering ways for MROs to determine if there is clinical 
evidence that an employee is an illicit drug user.

Making SVT Mandatory

    As we said in 2000, mandatory laboratory testing for specimen 
validity is an appropriate response to those who would tamper with the 
DOT's drug test results. Again, we propose the same position. It was 
the correct position in 2000, and we think it is the correct position 
now. Over the past several years, there have been an increasing number 
of products designed and marketed to adulterate specimens. Currently, 
there are more than 400 different products available for adulterating 
specimens, although many contain the same component adulterants. There 
are also devices marketed with the promise to hide drug use by 
substituting ``clean'' urine for a drug user's own urine. The cheating 
industry is real, and we must counter it. Furthermore, cheating on a 
drug test through adulteration or substitution is a deliberate and 
direct attempt to thwart the testing process. Therefore, we are 
proposing to require SVT for all DOT specimens.
    In their Mandatory Guidelines, HHS established SVT requirements 
with which laboratories must comply in order to become and remain HHS-
certified. HHS has stated that their SVT standards are designed to 
produce the most accurate, reliable, and correctly interpreted test 
results. Currently, when DOT specimens are tested for validity, the SVT 
adheres to HHS procedural standards.
    In 2000, we estimated an annual cost associated with SVT of about 
$1.4 million. At that time, a majority of HHS-certified laboratories 
were already conducting SVT. The larger laboratories, who were 
receiving the vast majority of transportation industry specimens, were 
all conducting SVT. These facts led us to estimate approximately 80% of 
industry specimens were being tested for specimen validity in 2000.
    Because employers are deeply concerned about specimen tampering and 
because HHS certification relies (in part) upon a laboratory's ability 
to conduct SVT, we estimate that an even higher percentage of 
transportation industry specimens are undergoing SVT now than in 2000. 
We estimate that 95% of industry specimens are undergoing SVT, up from 
80% in 2000.
    That higher percentage coupled with the fact that fewer specimens 
are being collected now than were collected in 2000, leads us to 
believe the increased cost of requiring SVT for those specimens not 
currently undergoing SVT will be even less than our 2000 cost estimate. 
There were 6.67 million industry tests conducted in 2005, down from 7 
million industry tests in 2000. Therefore, we estimate that the cost of 
new SVT will be about $1 million, down from the $1.4 million figure 
estimated in 2000.

2003 IFR Comments to the Docket

    The comments to the May 28, 2003 IFR were generally supportive of 
the DOT's decision to modify the creatinine levels required to call a 
substituted specimen ``a refusal to test.'' Some supported the DOT's 
diligence in pursuing the subject of creatinine levels of substituted 
specimens, and a few others expressed the desire to do away with SVT 
altogether. Another commenter said we were making an accommodation for 
a situation that was likely not to exist, so this commenter recommended 
that the DOT make no change with regard to substituted specimen 
refusals.
    Most comments to the docket expressed, in one form or another, the 
desire to have SVT laboratory standards developed and issued in final 
guidance by HHS. That way, commenters reasoned, all laboratories would 
be responsible for adhering to the SVT standards and would be held 
accountable for them. These commenters had a variety opinions related 
to the cutoff levels and testing ranges for SVT. Most indicated that 
they had provided similar comments to HHS when it proposed SVT for the 
Mandatory Guidelines. A few commenters discussed procedural issues for 
MROs in dealing with substituted specimens with creatinine in the 2-5 
mg/dL range and with the period of time the IFR allowed for an 
employee's obtaining a required for medical evaluation.
    Additionally, several comments (from an employee, two employee 
associations, and an attorney) expressed the desire to have the DOT 
remedy the records of employees whose refusals to test prior to May, 
2003, had been the result of having substituted specimens. Their 
specific gravity levels had been in the substituted range, but their 
creatinine had apparently been in the 2-5 mg/dL range. At least two 
commenters brought up issues totally unrelated to SVT.

2004 IFR Comments to the Docket

    The comments to the November 9, 2004 IFR, especially those from 
laboratories, were favorable about the DOT's decision to take measures 
to align part 40 with HHS SVT procedures. One association requested 
that we go further with the alignment by making SVT mandatory rather 
than leaving it optional. One Third Party Administrator (TPA) 
recommended that we provide guidance on who (e.g., employer, 
laboratory, TPA) makes the decision to authorize SVT.
    Two MROs favored the DOT's decision to keep their 2003 IFR 
requirement to order an immediate recollection under direct observation 
when a verified negative-dilute that contained creatinine in the 2-5 
mg/dL range. One of those MROs spoke about what he considered the high 
rate of positive results for those recollections. However, one employee 
association was opposed to the recollection requirement for creatinine 
in the 2-5 mg/dL range. In fact, the association wanted the DOT to do 
away with the below 2 creatinine substitution criteria established by 
HHS, in essence wanting there to be no specimens considered 
substituted. Additionally, the association also expressed a desire to 
have the DOT expunge the records of those employees with substitution 
refusals prior to May, 2003. Their specific gravity levels had been in 
the substituted range, but their creatinine had tested in the 2-5 mg/dL 
range.
    A laboratory requested that we require laboratories to report 
quantitative values on all dilutes (not just negative-dilutes) because, 
in the event a positive-dilute was downgraded by the MRO, the 
creatinine level would be important for the MRO to know. About 
negative-dilutes, one of the MROs suggested the category of dilute 
specimens having creatinine above 5 mg/dL was superfluous to the 
process. He suggested doing away with that category of dilute results 
altogether.
    One of the TPAs recommended the Department find an easier way for 
employers to determine which laboratories use two SVT methodologies, 
rather than one, so that the number of invalid results would be

[[Page 62279]]

kept to a minimum. The TPA recommended that HHS amend its laboratory 
certification list to accommodate this request. Also, the TPA 
recommended that we use [for example], ``As an MRO, you must ``* * *'' 
throughout part 40 as a means of making it easier to figure out whose 
actions are being directed.

DOT Response to the 2003 and 2004 IFR Comments to the Docket

    A major factor in the DOT's decisions to withdraw part 40's 
mandatory SVT (in 2001) and to create the 2003 IFR regarding MRO 
actions on laboratory reported substituted specimens was the fact that 
HHS had not finalized or updated SVT in their Mandatory Guidelines. 
Likewise, our decisions to establish the 2004 IFR--which served to 
bring part 40's SVT more in-line with the HHS--and to write this NPRM 
were based upon the fact that HHS finalized and published its Mandatory 
Guidelines effective November 1, 2004.
    The HHS Mandatory Guidelines have gone far toward alleviating many 
of the concerns of the commenters. Specifically, IFR commenters 
explained that no mandatory SVT standards existed for laboratories to 
follow. They were also concerned that the DOT program operated with 
different SVT criteria than the HHS program. They noted the 
laboratories were not certified for their abilities to conduct SVT, and 
that appropriate procedures and cutoff criteria for SVT had not been 
established by HHS. Under the new HHS Mandatory Guidelines, HHS has set 
mandatory SVT standards. HHS certification depends upon laboratory SVT 
capabilities (among other things), and HHS has established appropriate 
SVT reporting criteria and cutoff levels.
    Nonetheless, there will continue to be some disagreement between 
those who desire to have no SVT and those who believe the established 
SVT criteria are not stringent enough. However, we are proposing that 
all DOT specimens be tested for all SVT, and that those tests will 
follow procedures and cutoff criteria established in the HHS Mandatory 
Guidelines. We believe the HHS has presented well-reasoned Mandatory 
Guidelines and have, in the preamble to that document, forthrightly 
explained their ongoing review and analysis of SVT results and 
scientific criteria.
    Also, we believe the Mandatory Guidelines work well in harmonizing 
with the 2000 part 40's positions to make SVT mandatory, to grant 
employees the right of MRO review and split specimen testing for SVT, 
and to provide (in certain instances) for the retesting of the primary 
specimen for SVT if the split specimen fails to reconfirm a drug 
metabolite. In addition, the Mandatory Guidelines reflect the DOT's 
desire (as made operational by the 2003 IFR) to change the creatinine 
criteria needed (in addition to the long-required specific gravity 
criteria) to call a specimen substituted.
    IFR issues related to a laboratory's use of two SVT methodologies 
versus one, MRO and employer actions with negative-dilute specimens 
having creatinine in the 2-5 mg/dL range, and laboratories reporting 
creatinine values for positive-dilute specimens are fully expanded in a 
later section called Other NPRM Issues and Questions.
    Regarding the 2004 IFR comment asking us to clarify which persons 
or entities currently provide authorization for a laboratory to conduct 
SVT under the DOT program, the authorization comes from part 40. Having 
said that, until part 40 makes SVT mandatory (rather than authorized), 
employers need to take active roles in determining the SVT they want 
laboratories to conduct on their behalf. The contracts between 
employers and laboratories are important. A laboratory needs to let 
employers know the SVT available to them and whether the laboratory 
uses two separate methodologies or one when conducting SVT. The more 
prudent employers will likely select a full range of SVT. The DOT 
appreciates the fact that most DOT-regulated specimens are undergoing 
SVT and would encourage employers to conduct the full range of SVT.
    Finally, the DOT views the NPRM as an opportunity to consider our 
positions on SVT and propose modifications accordingly. It was not our 
intention to conduct a full review of part 40. Nor was it our intention 
to focus on issues that fall under the sole purviews of HHS Mandatory 
Guidelines (e.g., the contents of the HHS laboratory listing) and DOT 
agency regulations (e.g., the make-up of ``actual knowledge'' 
provisions). Therefore, we have no responses to IFR comments addressing 
such topics.

DOT Response to 2003 and 2004 IFR Comments Requesting That the 
Department Rectify Past Substitution Refusals

    In both the 2003 and 2004 IFRs, there were calls for the DOT to 
take action to rectify what several commenters believed to be a 
mischaracterization of some employee refusals to test. Some of the 
comments suggest that we take measures to clear employee records of 
refusals to test if their substituted refusals showed creatinine in the 
2-5 mg/dL range and those refusals were reported between September 1998 
and May 2003.
    For this discussion, there are several important time-lines and 
actions to take into consideration:
    1. In September 1998, HHS established guidance regarding laboratory 
testing requirements for determining if a urine specimen should be 
reported to the MRO as being substituted. Specimens had two testing 
criteria in order to be reported as substituted: The specimen's 
creatinine level must have been 5 mg/dL or less and the specimen's 
specific gravity must have been less than or equal to 1.001 or greater 
than or equal to 1.020.
    2. In December 2000, part 40 implemented procedures for MRO review 
and for split specimen testing for SVT, to include substituted 
specimens. Therefore, employees could show MROs that they had medical 
reasons for producing the result and proof they could naturally produce 
substituted specimens. By doing so, their results would be cancelled.
    3. We issued the 2003 IFR so that MROs would not treat substituted 
specimens with creatinine concentration in the 2-5 mg/dL range as 
substituted specimens.
    4. Nearly a year later, HHS revised their Mandatory Guidelines with 
an effective date of November 1, 2004. Among the revisions contained in 
the HHS Mandatory Guidelines was the requirement that laboratories 
modify substituted specimen criteria. As a result, there are no 
specimens with creatinine levels greater than or equal to 2 mg/dL being 
reported by laboratories as substituted.
    The question now is whether we should so do something about those 
employees who may have been incorrectly charged with refusing their 
drug tests because they had substituted specimens with creatinine in 
the 2-5 mg/dL range. The answer is that we should.
    Consequently, the DOT will issue an Informational Notice, 
separately from this NPRM, directing action on this matter. The notice 
permits employees to present information to us showing that they had a 
refusal to test before May 2003. The reason for the refusal must be 
based upon the employee's having a substituted specimen result with a 
creatinine concentration in the 2-5 mg/dL range. Employees will also 
have to present proof that they are able to produce such specimens by 
virtue of medical evaluations. If the DOT determines that an employee's 
refusal fell within these parameters and the supporting documentation 
shows that

[[Page 62280]]

the employee can produce such specimens, we will reconsider the 
employee's original refusal-to-test result.

Section-by-Section NPRM Issues

    1. Index Changes--We would modify some existing section headings 
and added three new section headings in order to reflect regulation 
text changes. All told, eight section headings have been modified or 
added.
    2. Definition changes--In order to align more closely our 
definitions section (Sec.  40.3) with definitions contained in the HHS 
Mandatory Guidelines, we propose to modify some of our existing 
definitions and add some new ones. Eleven definitions would be modified 
or added to harmonize with HHS definitions.
    3. SVT Mandatory--We would make SVT mandatory by removing the 
option to conduct SVT (at Sec.  40.89) and adding text requiring SVT. 
This text is similar to the wording that had been removed from part 40 
in 2001.
    4. Adulterant and Invalid Testing Cutoffs--We propose to add two 
tables (one at the existing Sec.  40.95, the other at a new Sec.  
40.96) which will serve to inform MROs and others about the cutoffs and 
procedures laboratories are directed by HHS to use in reporting 
adulterants and invalid test results. However, we seek comment on 
whether this information will be helpful to MROs and other service 
agents or whether it will prove to be too much information that is too 
complicated to add value to the testing process.
    5. Primary Specimen Laboratory Results--Laboratories are reporting 
and MROs are reviewing a variety of test results, to include multiple 
test results for the same testing event. We believe that proposed 
changes to Sec.  40.97--which highlight categories of primary results--
and the sections related to medical review and reporting, especially 
Sec. Sec.  40.159(f) and 40.162, will make it easier for laboratories 
and MROs to understand how to deal with and report multiple test 
results. Comments from MROs regarding these categories of results will 
prove especially useful to us.
    6. Reporting Invalid Results with No Employee Interview--MROs have 
informed us of situations in which neither they nor the employers were 
able to contact employees to complete the interview process for invalid 
results. These MROs have wondered how they are to close these results. 
We propose to modify Sec.  40.133 so that invalids will be handled 
parallel to part 40's directives on positive, adulterated, and 
substituted specimens when the employee cannot be interviewed.
    7. Closing the Invalid Loops--The NPRM addresses the issues an MRO 
faces when the employee produces a second invalid result after 
providing a recollection under direct observation because of an initial 
invalid result. The NPRM also addresses what an MRO is to do after an 
invalid test result is cancelled by the MRO because of a legitimate 
reason and a negative result is required (i.e., because the test type 
is pre-employment, return-to-duty, or follow-up).
    a. Regarding a second invalid result for the same reason, we would 
amend Sec.  40.159 to require the MRO to report the test result as 
canceled after confirming with the collector that the collection had 
been properly observed.
    b. Regarding a second invalid result for a different reason, we 
would amend Sec.  40.159 to require the MRO to report the test result 
as a refusal after confirming with the collector that the collection 
had been properly observed. At Sec.  40.191, we would add this to the 
list of what constitutes a refusal to take a DOT test. This refusal 
requirement is in alignment with the HHS MRO Manual.
    c. Regarding obtaining a negative result when a valid test result 
cannot be produced and a negative result is needed, we propose to add a 
new Sec.  40.160 which requires the MRO to determine if there is 
clinical evidence that the individual is an illicit drug user. The 
evaluation requirements in this section would be parallel to existing 
part 40 requirements at Sec.  40.195 when a permanent or long term 
medical condition is the cause of the inability to provide a sufficient 
specimen and a negative result is needed. Like Sec.  40.195, the 
medical procedures would apply only when a negative result is needed 
for pre-employment, return-to-duty, and follow-up testing. Also, we 
seek 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. 
Should the DOT continue to require that the tests be cancelled or treat 
them as positives?
    8. Split Specimen Results--Because of the myriad of possible test 
results, perhaps no section of the HHS Mandatory Guidelines is more 
complex than the one dedicated to split specimens. In the NPRM, we have 
attempted to categorize the split results--much the same way we did for 
the primary results--in order to make it easier for MROs to understand 
their responsibilities should they receive any of the more complicated 
split result possibilities. Comments from MROs regarding these 
categories of results will prove especially useful to us. Also, we seek 
comments on whether a table in the Appendix would help make the MRO's 
split specimen requirements easier to understand.
    a. We would amend Sec.  40.171 to state that there is no split 
specimen testing for an invalid result. This is consistent with current 
part 40 split request procedures and with the HHS MRO Manual.
    b. We propose to amend Sec. Sec.  40.177, 40.179, and 40.181 so 
that a provision currently contained only in Sec.  40.177 is expanded 
to the adulterated and substituted split sections. Under the proposal, 
we would provide authorization for the split laboratory to forward the 
split specimen or a portion of it to another HHS-certified laboratory 
if the split fails to reconfirm the presence of validity criteria. We 
believe the provision fits well into these adulterated and substituted 
sections. We seek comment on whether providing authorization to the 
split laboratory would be sufficient, or should the DOT require them to 
forward the split specimen or portion of it.
    c. The NPRM would simplify the many possibilities for split 
specimen results by placing them into five distinct categories in Sec.  
40.187. One category contains MRO actions for split specimens that 
reconfirm all or some of the primary specimen results. Another contains 
MRO actions when the split fails to reconfirm all the primary specimen 
results because drugs were not detected and/or validity criteria were 
not met. The third category outlines MRO actions when the split fails 
to reconfirm all the primary specimen results and the split is reported 
as invalid, adulterated, and/or substituted. A fourth category details 
actions an MRO is to take when the split fails to confirm some but not 
all of the primary specimen results and the split is also reported as 
invalid, adulterated, and/or substituted. The final category delineates 
MRO responsibility when the split specimen is not available for testing 
or there is no split laboratory available to test the split specimen.
    d. The NPRM would modify Sec.  40.187 so that if a split fails to 
reconfirm all primary results but is reported as substituted, the MRO 
will be required to follow medical review procedures for substituted 
specimens and offer retest of the primary specimen if the MRO verifies 
the result as a refusal to test. This requirement is the same as the 
current part 40 procedures for MRO and laboratory actions after the 
split fails to

[[Page 62281]]

reconfirm the primary results but is reported as adulterated.
    9. Recollections--In Sec. Sec.  40.197 and 40.201, we propose to 
change the regulation to clarify issues related to recollections for 
dilute specimens, for splits that are reported as invalid, and for a 
situation in which there is no split laboratory available to test the 
split specimen.
    10. Appendix Items--At Appendix B, we propose to modify the semi-
annual laboratory report so that it will have the same information 
required by the HHS Mandatory Guidelines. The three proposed changes, 
while not dramatic, will help laboratories avoid needing two different 
report formats, one for DOT and one for HHS. We would also amend some 
Appendix F citations so that they will accurately reflect NPRM text 
changes.

Other NPRM Issues and Questions

    1. MROs, TPAs, and collectors have asked the Department to clarify 
issues of multiple results reporting. Multiple results can be reported 
by laboratories because of several reasons. For instance, two 
collections (one unobserved, the other observed) occur during the same 
testing event because the first collection was out of temperature range 
or showed signs of tampering; a primary specimen had multiple test 
results; or a test result was one that required a subsequent 
collection.
    We believe the NPRM clearly delineates our proposals for MRO 
actions in multiple results situations and would like to have your 
comment about them. However, we also want to know your thoughts about 
the relative worth of continuing to have the collector send in two 
specimens (i.e., a temperature out of range specimen or one that showed 
signs of tampering and the subsequent observed specimen) instead of 
sending only the specimen collected under direct observation.
    Do the complications caused by linking (or failure to link) the two 
collections outweigh the possibility that the initial specimen will be 
non-negative while the observed specimen will be negative or cancelled? 
What are some of the complications employers and MROs have experienced 
by having two different results on the two specimens for the same 
testing event? Can MROs report the verified results for two specimens 
for the same testing event on the same report? Do we simply need to 
make it clearer in part 40 that a non-negative result(s) for one 
specimen takes precedence over a negative or cancelled result for the 
other specimen?
    2. Invalid result rates have risen slightly and adulterated 
specimen rates decreased slightly since HHS required laboratories to 
utilize two separate SVT methodologies before they can report results 
as adulterated. If the laboratory identifies the possible presence of 
adulterant in a urine specimen using one testing methodology, they will 
call the specimen invalid. This does not apply to pH testing using a pH 
meter for both the initial and confirmation tests. Please provide us 
with your comments on the benefits of requiring all laboratories 
conducting DOT testing to utilize two methodologies for SVT (except pH) 
or for directing employers to use only laboratories that employ two 
methodologies. What will be the associated costs to laboratories and 
employers for requiring laboratories to utilize two methodologies?
    For invalid results, are required recollections under direct 
observation timely enough to identify drug use? Before laboratories 
report invalid results, are they contacting MROs (as required by the 
DOT and HHS) to discuss if sending the specimen to another HHS-
certified laboratory will be useful?
    3. We propose no change to the 2004 IFR in the treatment of 
negative-dilute specimens with creatinine in the 2-5 mg/dL range as 
needing to be recollected under direct observation. The result of the 
second specimen will continue to be the result of record even if it is 
again negative-dilute. MROs have informed us that a number of the 
recollected observed specimens have produced positive results. Some of 
the reports we have received indicate that while some employees can 
normally produce specimens with creatinine in the 2-5 mg/dL range, 
others cannot achieve those results without tampering with their 
specimens. We are interested in your comments as to whether the DOT 
should continue to require recollection under direct observation for 
these negative-dilute results.
    Are the negative-dilute recollections under direct observation 
yielding results that show employee drug use? Given the threat to 
public safety, what percentage of positive results on these 
recollections would be considered too low to justify conducting them?
    4. Neither DOT nor HHS has required laboratories to report 
numerical values for creatinine and specific gravity for positive-
dilute specimens, like we do for negative-dilute results. When MROs 
downgrade positive results to negative based upon legitimate medical 
reasons for these positive-dilute specimens, there is no additional MRO 
action because the dilute numerical values are not reported. Therefore, 
employers are not able to take the additional recollection actions 
afforded other negative-dilute specimen results.
    Should MROs have the same reporting responsibilities for downgraded 
negative-dilute results as they have for any other negative-dilute 
result? Should employers have the same responsibilities to recollect 
under direct observation when the creatinine concentration is in the 2-
5 mg/dL range or the same recollection options if creatinine is above 5 
mg/dL?
    5. Realistic-looking prosthetic devices which hold and heat urine 
(or water mixed with powdered urine) are available for purchase and are 
known to have been used during observed collections. They are available 
in a variety of colors making them difficult to detect. We are 
interested in your comments as to the appropriateness of having a 
collector make sure that the employee is not using a prosthetic device 
during an observed collection.
    For example, would it be appropriate to require that collectors and 
observers, as appropriate, check for these devices by having male 
employees lower their pants and underwear just before observed 
collections take place? What should be the consequence if a device is 
found?

Regulatory Analyses and Notices

    The statutory authority for this rule derives from the Omnibus 
Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 
5331, 20140, 31306, and 45101 et seq. and the Department of 
Transportation Act (49 U.S.C. 322).
    This rule is not significant for purposes of Executive Order 12866 
or the DOT's regulatory policies and procedures. It proposes 
modifications to our overall part 40 procedures and is intended to 
further align our laboratory and MRO procedures with those requirements 
that are being directed by HHS. Their economic effects will be 
negligible. Consequently, the DOT certifies, under the Regulatory 
Flexibility Act, this rule will not have a significant economic impact 
on a substantial number of small entities.
    In the 2000 part 40, 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. Current estimates are that 95% of industry specimens are 
already undergoing SVT on a voluntary basis. This higher percentage, 
coupled with the fact that fewer specimens are being collected now than 
were collected in 2000, leads us to believe the

[[Page 62282]]

incremental cost of SVT for those specimens not currently undergoing 
SVT will be even less than our 2000 cost estimate. There were 6.67 
million industry tests conducted in 2005, down from 7 million industry 
tests in 2000.\1\ Therefore, we estimate that the annual cost of new 
SVT will be about $1 million.
---------------------------------------------------------------------------

    \1\ The lower number of tests may result from two factors. 
First, the 2000 number was an estimate, while the 2005 number is 
based on actual reporting. It is possible that the 2000 number was 
on the high side. Second, the operating administrations believe that 
employment and turnover in some industries (e.g., the motor carrier 
industry) may have declined in recent years, resulting in fewer 
tests.
---------------------------------------------------------------------------

    Anyone is able to search the electronic form of all comments 
received into any of our dockets by the name of the individual 
submitting the comment (or signing the comment, if submitted on behalf 
of an association, business, labor union, etc.). You may review DOT's 
complete Privacy Act Statement in the Federal Register published on 
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit 
http://dms.dot.gov.

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: October 21, 2005.
Norman Y. Mineta,
Secretary of Transportation.

49 CFR Subtitle A--Authority and Issuance

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

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

    1-2. 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.

    3. Section 40.3 is proposed to be 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 ``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.
* * * * *
    Confirmatory drug test. A second analytical procedure to identify 
the presence of a specific drug or metabolite which is independent of 
the initial test and which uses a different technique and chemical 
principle from that of the initial test in order to ensure reliability 
and accuracy. (Gas chromatography/mass spectrometry (GC/MS) is the only 
authorized confirmation method for cocaine, marijuana, opiates, 
amphetamines, and phencyclidine).
    Confirmatory validity test. A second test performed on a different 
aliquot of the original urine specimen to further support a validity 
test result.
* * * * *
    Dilute specimen. A urine specimen with creatinine and specific 
gravity values that are lower than expected for human urine.
* * * * *
    Initial drug test (also known as a Screening drug test). An 
immunoassay test to eliminate ``negative'' urine specimens from further 
consideration and to identify the presumptively positive specimens that 
require confirmation or further testing.
    Initial validity test. The first test used to determine if a urine 
specimen is adulterated, diluted, or substituted.
    Invalid result. Refers to 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. Examples of these 
agents include, but are not limited to, nitrites, pyridinium 
chlorochromate, chromium (VI), bleach, iodine, halogens, peroxidase, 
and peroxide.
* * * * *
    Screening drug test. See Initial drug test definition above.
* * * * *
    Substituted specimen. A specimen with creatinine and specific 
gravity values that are so diminished or so divergent that they are not 
consistent with normal human urine.
* * * * *
    4. Section 40.23 is proposed to be 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 specimen 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.
* * * * *
    5. Section 40.83 is proposed to be 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).
* * * * *
    6-7. Section 40.89 is proposed to be 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.
    8. Section 40.95 and its heading are proposed to be revised to 
read:


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

    (a) As a laboratory, you must use the cutoff concentrations 
displayed in the following table for the initial and

[[Page 62283]]

confirmation adulterant tests. The table follows:

------------------------------------------------------------------------
       Adulterant test            Initial test        Confirmation test
------------------------------------------------------------------------
(1) pH......................  Less than 3 or        Less than 3 or
                               greater than 11.      greater than 11.
(2) Nitrite.................  Greater than 500 mcg/ Greater than 500 mcg/
                               mL.                   mL.
(3) Presence of Chromium      Greater than or       Chromium (VI)
 (VI).                         equal to 50 mcg/mL.   concentration
                                                     greater than or
                                                     equal to the Level
                                                     of Detection (LOD).
(4) Presence of Halogen.....  Greater than or       Specific halogen
                               equal to 200 mcg/mL   concentration
                               nitrite equivalent    greater than or
                               cutoff or             equal to the LOD.
                              Greater than or
                               equal to 50 mcg/mL
                               Chromium (VI)
                               equivalent cutoff
                               or
                              Halogen
                               concentration
                               greater than or
                               equal to the LOD.
(5) Presence of               Aldehyde present or   Glutaraldehyde
 Glutaraldehyde.              Characteristic         concentration
                               immunoassay           greater than or
                               response on drug      equal to the LOD.
                               test.
(6) Presence of Pyridine....  Greater than or       Pyridine
                               equal to 200 mcg/mL   concentration
                               nitrite equivalent    greater than or
                               cutoff or             equal to the LOD.
                              Greater than or
                               equal to 50 mcg/mL
                               Chromium (VI)
                               equivalent cutoff
                               or
                              Greater than or
                               equal to 50 mcg/mL
                               Chromium (VI)
                               concentration.
(7) Presence of Surfactant    Greater than or       Greater than or
 (dodecylbenzene sulfonate-    equal to 100 mcg/mL.  equal to 100 mcg/
 equivalent).                                        mL.
(8) Presence of other         Greater than or       Greater than or
 adulterant.                   equal to the LOD.     equal to the LOD.
------------------------------------------------------------------------

    (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 values that support the 
adulterated result.
    9. A new Sec.  40.96 is proposed to be 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 
displayed in the following table. The table follows:

------------------------------------------------------------------------
    Invalid test category         Initial test        Confirmation test
------------------------------------------------------------------------
(1) Creatinine & Specific     Creatinine less than  Creatinine less than
 Gravity.                      2 mg/dL and           2 mg/dL and
                               specific gravity is   specific gravity is
                               greater than 1.0010   greater than 1.0010
                               but less than         but less than
                               1.0200 or             1.0200
                              Specific gravity is   Specific gravity is
                               less than or equal    less than or equal
                               to 1.0010 and         to 1.0010 and
                               creatinine is         creatinine is
                               greater than or       greater than or
                               equal to 2 mg/dL.     equal to 2 mg/dL.
(2) pH......................  Greater than or       Greater than or
                               equal to 3 and less   equal to 3 and less
                               than 4.5 using a      than 4.5 using a pH
                               colorimetric pH       meter.
                               test or pH meter or
                              Greater than or       Greater than or
                               equal to 9 and less   equal to 9 and less
                               than 11 using a       than 11 using a pH
                               colorimetric pH       meter.
                               test or pH meter.
(3) Nitrite.................  Greater than or       Greater than or
                               equal to 200 mcg/mL   equal to 200 mcg/mL
                               using a nitrite       but less than 500
                               colorimetric test     mcg/ml using a
                               or                    different
                                                     confirmatory test.
                              Greater than or       Greater than or
                               equal to the          equal to 200 mcg/mL
                               equivalent of 200     but less than 500
                               mcg/mL nitrite        mcg/mL using the
                               using a general       same general
                               oxidant               oxidant
                               colorimetric test     colorimetric test.
                               or
                              Greater than or       Greater than or
                               equal to the          equal to 200 mcg/mL
                               equivalent of 200     but less than 500
                               mcg/mL using a        mcg/ml using a
                               general oxidant       different
                               colorimetric test.    confirmatory test.
(4) Chromium (VI)...........  Greater than or       Greater than or
                               equal to 50 mcg/mL    equal to 50 mcg/mL
                               using a chromium      using the same
                               (VI) colorimetric     chromium (VI)
                               test.                 colorimetric test.
(5) Halogen.................  Greater than or       Greater than or
                               equal to the LOD      equal to the LOD
                               using a hologen       using the same
                               colorimetric test     halogen test
                               or                    colorimetric test.
                              Odor of the specimen  Greater than or
                                                     equal to the LOD
                                                     using a halogen
                                                     colorimetric test.
(6) Glutaraldehyde..........  Aldehyde present      Aldehyde present
                               using an aldehyde     using the same
                               test or               aldehyde test.
                              Characteristic        Characteristic
                               immunoassay           immunoassay
                               response on initial   response on
                               drug test.            confirmatory drug
                                                     test.
(7) Oxidizing Adulterant....  Greater than or       Greater than or
                               equal to 200 mcg/mL   equal to 200 mcg/mL
                               nitrite-equivalent    nitrite-equivalent
                               using a general       using the same
                               oxidant               general oxidant
                               colorimetric test     colorimetric test.
                               or
                              Greater than or       Greater than or
                               equal to 50 mcg/mL    equal to 50 mcg/mL
                               chromium (VI)-        chromium (VI)-
                               equivalent using a    equivalent using
                               general oxidant       the same general
                               colorimetric test     oxidant
                               or                    colorimetric test.
                              Greater than or       Greater than or
                               equal to the LOD      equal to the LOD
                               halogen               halogen
                               concentration using   concentration using
                               a general oxidant     the same general
                               colorimetric test.    oxidant
                                                     colorimetric test.
(8) Surfactant..............  Greater than or       Greater than or
                               equal to 100 mcg/ml   equal to 100 mcg/ml
                               dodecylbenzene        dodecylbenzene
                               sulfonate-            sulfonate-
                               equivalent using a    equivalent using a
                               surfactant            the same surfactant
                               colorimetric test     colorimetric test.
                               or

[[Page 62284]]

 
                              Foam/shake test.....  Greater than or
                                                     equal to 100 mcg/ml
                                                     dodecylbenzene
                                                     sulfonate-
                                                     equivalent using a
                                                     surfactant
                                                     colorimetric test.
(9) Interference on           Valid drug test       Valid drug test
 immunoassay drug tests.       cannot be obtained.   cannot be obtained.
(10) Interference with the    No interfering        No interfering
 GC/MS drug confirmation       substance can be      substance can be
 assay.                        identified.           identified.
(11) Physical appearance of
 the specimen is such that
 it may damage laboratory
 equipment..
(12) Physical appearance of
 Bottles A and B are clearly
 different and Bottle A
 result is as stated in 1
 through 11, as appropriate,
 on this table..
------------------------------------------------------------------------

    (b) To obtain one of the invalid results outlined at 1 through 10 
of this table, as a laboratory, you must use two separate aliquots--one 
for the initial test and another for the confirmation test.
    (c) For a specimen having an invalid result for one of the reasons 
outlined at 4 through 12 of this table, as a laboratory, 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.
    (d) As a laboratory, you must report the reason a test result is 
invalid.
    10. Section 40.97 is proposed to be amended by adding the words, 
``and Rejected for Testing'' between ``Non-negative'' and ``results'' 
at 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 three 
categories. They are as follows:
    (1) Category 1: Negative Results. When a specimen is found to be 
negative, as a laboratory, 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. When a specimen is found to 
be non-negative, as a laboratory, you must report the test result as 
being one or more of the following, as appropriate:
    (i) Positive, with drug(s)/metabolite(s) noted;
    (ii) Positive-dilute, with drug(s)/metabolite(s) noted, with 
numerical values for creatinine and specific gravity;
    (iii) Adulterated, with adulterant(s) noted, with numerical values 
(when applicable), and with remarks(s);
    (iv) Substituted, with numerical values for creatinine and specific 
gravity; or
    (v) Invalid result, with remark(s).
    (3) Category 3: Rejected for Testing. When a specimen is rejected 
for testing, as a laboratory you must report the result as being 
Rejected for Testing, with remark(s).
* * * * *
    11. Section 40.103 is proposed to be 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 paragraphs (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.
* * * * *


Sec.  40.105  [Amended]

    12. Section 40.105 is proposed to be amended by adding in paragraph 
(c) the words ``adulterated, or substituted result'' after the word 
``positive,'' and before the word ``you'.
    13. Section 40.129 is proposed to be 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.  40.135-40.145, 40.159, and 40.160, as:
    (i) Negative; or
    (ii) Cancelled; or
    (iii) Positive, and/or refusal to test because of adulteration or 
substitution.
* * * * *
    14. Section 40.131 is proposed to be 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 laboratory confirmed non-negative drug test 
results?

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


Sec.  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-invalid, without interviewing the 
employee?

* * * * *

[[Page 62285]]

    (b) As the MRO, you may verify a test result as cancelled-invalid 
(with instructions to recollect immediately under direct observation) 
without interviewing the employee, as provided at Sec.  40.159, if:
    (1) 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 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 
refusal to test or as a cancelled-invalid result under this section, 
you must document the date and time and reason, following the 
instructions in Sec.  40.163, and, for a cancelled-invalid result, at 
Sec.  40.159(a)(5)(i).
    (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 
documenting 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.
    16. Section 40.149 is proposed to be amended by revising the 
section heading, removing the words ``positive or refusal to test'' in 
paragraph (a), and removing, in paragraph (a)(1), the reference to 
``Sec.  40.133(c)'' and adding in its place ``Sec.  40.133(d)'' to read 
as follows:


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

* * * * *
    17. Section 40.155 is proposed to be 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) Obtain verification from the collector that the recollection 
was directly observed.
    (2) If the recollection was directly observed, report this result 
to the DER as a negative-dilute result.
    (3) 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.
    18. Section 40.159 is proposed to be amended by revising paragraphs 
(a)(1) through (3), adding paragraphs (a)(4)(iii), and (d) through (f) 
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 the certifying scientist to 
determine if the primary specimen should be tested at another HHS 
certified laboratory. If the laboratory did not carried out its 
requirements to contact you at 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 should 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 physiological or anatomic abnormality 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's recollection (required at paragraph (a)(5) of 
this section) results in another invalid result for the same reason 
reported for the first specimen, as the MRO, you must:
    (1) Obtain verification from the collector that the recollection 
was directly observed.
    (2) If the recollection was directly observed, document that the 
employee had another specimen with an invalid result.
    (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.
    (e) If the employee's recollection (required at paragraph (a)(5) of 
this section) results in another invalid result for a different reason 
reported for the first specimen, as the MRO, you must report the test 
result as being a refusal.
    (f) 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 cancelled-invalid result unless the split 
specimen fails to reconfirm the result(s) of the primary specimen.
    19. Section 40.160 is proposed to be 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)(4)(iii) and (d)(4)), as the MRO, 
you must determine if there is clinical evidence that the individual is 
an illicit drug user. You must make this determination by personally 
conducting, or causing to be conducted, a medical evaluation and 
through consultation with the employee's physician (if appropriate).
    (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 the result to the employer as a 
negative test 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 another invalid result for the same reason, as 
appropriate) and for the determination that no signs and symptoms of 
drug use exist.

[[Page 62286]]

    (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 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 another invalid result for the same reason, 
as appropriate) and for the determination that signs and symptoms of 
drug use exist. Because this is a cancelled test, it does not serve the 
purposes of a negative test (i.e., the employer is not authorized to 
allow the employee to begin or resume performing safety-sensitive 
functions, because a negative test is needed for that purpose).
    20. Section 40.162 is proposed to be 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 would report the positives and the refusal to the DER.
    (b) If the testing event was one in which two separate specimen 
collections (e.g., a specimen out of temperature range and the 
subsequent observed collection) were sent to the laboratory, as the 
MRO, you must:
    (1) If both specimens were verified negative, report the result as 
negative.
    (2) If either of the specimens was verified negative and the other 
was verified non-negative(s), report the non-negative result(s). For 
example, if you verified one specimen as negative and other as a 
refusal to test because the specimen was substituted, as the MRO you 
would report the only the refusal to the DER.
    (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 would 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.
    21. Section 40.171 is proposed to be 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.
* * * * *
    22. Section 40.177 is proposed to be 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) that were reported in the primary specimen, 
you may transmit the specimen or an aliquot of it for testing at 
another HHS-certified laboratory that has the capability to conduct 
another reconfirmation test.
    23. Section 40.179 is proposed to be amended by revising the 
section 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 criteria of Sec.  40.95, just as you would do for a primary 
specimen.
    (b) In addition, if the test fails to reconfirm validity criteria 
reported in the primary specimen, you may transmit the specimen or an 
aliquot of it for testing at another HHS-certified laboratory that has 
the capability to conduct another reconfirmation test.
    24. Section 40.181 is proposed to be amended by revising the 
section 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?

    (a) As the laboratory testing the split specimen, you must test the 
split specimen using the criteria of Sec.  40.93(b), just as you would 
do for a primary specimen.
    (b) In addition, if the test fails to reconfirm validity criteria 
reported in the primary specimen, you may transmit the specimen or an 
aliquot of it for testing at another HHS-certified laboratory that has 
the capability to conduct another reconfirmation test.
    25. Section 40.183 is proposed to be amended by revising paragraph 
(a), removing paragraph (b), and re-designating paragraph (c) as 
paragraph (b), to be read as follows:


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.
* * * * *
    26. Section 40.187 is proposed to be amended by revising the 
section 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 all or some of the 
primary specimen results.
    (1) As the MRO, you must report to the DER and employee which 
result(s) was/were reconfirmed.
    (2) In the case of a reconfirmed positive test(s) for drug(s) or 
drug metabolite(s), the positive is the final result.
    (3) In the case of a reconfirmed adulterated or substituted result, 
the refusal to test is the final result.
    (4) In the case of 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.
    (1) As the MRO, you must report to the DER and the employee that 
the test must be cancelled.
    (2) As the MRO, you must inform ODAPC of the failure to reconfirm 
using the format in Appendix D to this part.
    (3) In a case where the split failed to reconfirm because the 
substitution

[[Page 62287]]

criteria were not met because the split specimen creatinine 
concentration was greater than 2mg/dL but less than or equal to 5mg/dL, 
as the MRO, you must, in addition to steps at (b)(1) and (2) 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.
    (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 cancellation.
    (ii) Direct the DER to ensure the immediate collection of another 
specimen from the employee under direct observation, with no notice 
given to the employee of this collection requirement until immediately 
before the collection.
    (iii) Inform ODAPC of the failure to reconfirm using the format in 
Appendix D to this part.
    (2) In the case where the laboratory failed to reconfirm any of the 
primary specimen results, and the split was reported as adulterated 
and/or substituted, as the MRO, you must:
    (i) Contact the employee and inform the employee that the 
laboratory has determined that his or her split specimen is adulterated 
and/or substituted, as appropriate.
    (ii) Follow the procedures of Sec.  40.145 to determine if there is 
a legitimate medical explanation for the laboratory finding of 
adulteration and/or substitution, as appropriate.
    (iii) If you determine that there is a legitimate medical 
explanation for the adulterated and/or substituted test result, report 
to the DER and the employee that the test must be cancelled; and inform 
ODAPC of the failure to reconfirm using the format in Appendix D to 
this part.
    (iv) If you determine that there is not a legitimate medical 
explanation for the adulterated and/or substituted test result, 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 also is present in the primary specimen 
and/or to determine if the primary specimen meets appropriate 
substitution criteria.
    (B) Except that 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 
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)(3) 
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 some but not 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 reconfirmed one or more of the 
primary specimen result(s), as the MRO, you must follow procedures in 
paragraph (a) of this section and:
    (2) Report that the split was reported also as being invalid, 
adulterated, and/or substituted (as appropriate).
    (3) 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.
    (1) As the MRO, you must report to the DER and the employee that 
the test must be cancelled and the reason for the cancellation.
    (2) As the MRO, you must also 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.
    (3) As the MRO, you must notify ODACP 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.
    27. Section 40.191 is proposed to be amended by redesignating 
paragraphs (c) through (e) as (d) through (f), respectively, and adding 
paragraph (c) to read as follows:


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

* * * * *
    (c) As an employee, if you have a recollection under direct 
observation because of an invalid test result and the MRO reports the 
result of the observed specimen as being invalid for a different reason 
than the first specimen, you have refused to take a drug test.
* * * * *
    28. Section 40.197 is proposed to be amended by revising paragraph 
(c)(3), redesignating paragraph (c)(4) as (c)(5), and adding 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.
* * * * *
    29. Section 40.201 is proposed to be 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 split specimen failed to reconfirm all of the primary 
specimen results because 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 40.187(b) (no 
recollection is required in this case, unless the specimen creatinine 
concentration for a substituted specimen was greater than 2mg/dL but 
less than or equal to 5mg/dL--which requires recollection under direct 
observation).

[[Page 62288]]

    (d) The split specimen failed to reconfirm all of the primary 
specimen results, and reported that the split specimen was invalid. You 
must follow the procedures in 40.187(c)(1) (recollection under direct 
observation is required in this case).
    (e) The split specimen failed to reconfirm all of the primary 
specimen results because the split specimen was not available for 
testing or there was no split laboratory available to test the 
specimen. You must follow applicable procedures in 40.187(e) 
(recollection under direct observation is required in this case).
* * * * *


Sec.  40.207  [Amended]

    30. Section 40.207 is proposed to be amended by removing, in 
paragraph (a)(3), the reference to ``40.187(b)'' and adding in its 
place ``40.187(b)(3), (c)(1), and (e)''.
    31. Appendix B to Part 40 is proposed to be amended by revising it 
to read as follows:

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

    The summary report shall contain the following information:

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)

Appendix F to Part 40--[Amended]

    32. Appendix F to Part 40 is proposed to be amended by removing the 
references to Sec.  40.187(a)-(f) and Sec.  40.191(d) and adding in 
their place Sec.  40.187(a)-(e) and Sec.  40.191(e), respectively.

[FR Doc. 05-21488 Filed 10-28-05; 8:45 am]
BILLING CODE 4910-62-P


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