**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

**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 \[insert date 60 days from date of publication in the
[Federal Register]{.underline}\]. 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:

-   Web Site: [http://dms.dot.gov](http://dms.dot.gov/) . Follow the
    instructions for submitting comments on the DOT electronic docket
    site.

-   Fax: 1-202-493-2251.

-   Mail: Docket Management Facility; US Department of Transportation,
    400 Seventh Street, SW., Nassif Building, Room PL-401, Washington,
    DC 20590-0001.

-   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.

-   Federal eRulemaking Portal: Go to
    [http://www.regulations.gov](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](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](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

**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
[jim.swart@dot.gov](mailto:jim.swart@ost.dot.gov) (e-mail).

S**UPPLEMENTARY 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 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 § 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
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 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]{.underline} testing criteria in order to be reported as
substituted: The specimen's creatinine level must have been 5 mg/dL or
less [and]{.underline} 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
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 (§ 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 § 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 § 40.95, the other at a new § 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 § 40.97 -- which highlight categories of primary results --
and the sections related to medical review and reporting, especially §§
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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 §§ 40.177, 40.179, and 40.181 so that a
provision currently contained only in § 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 § 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 § 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
reconfirm the primary results but is reported as adulterated.

9\. Recollections \~ In §§ 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 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.

#  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](http://dms.dot.gov/).

[List of Subjects in 49 CFR Part 40]{.underline}

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

49 CFR subtitle A

Authority and Issuance

Dated:

Norman Y. Mineta,

Secretary of Transportation

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

**PART 40 -- PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL
TESING 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\. § 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:

**§ 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, dilute, 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\. § 40.23 is proposed to be amended by revising paragraph (f)
introductory text and adding paragraph (f)(5), to read as follows:

**§ 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\. § 40.83 is proposed to be amended by revising paragraph (g)(2) to
read as follows:

**§ 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 § 40.97(a)(3).

\* \* \* \* \*

6-7. § 40.89 is proposed to be amended by revising paragraph (b) to read
as follows:

**§ 40.89 What is validity testing, and are laboratories required to
conduct it?**

\* \* \* \* \*

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

8\. § 40.95 and its heading are proposed to be revised to read:

**§ 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 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    | Greater than 500     |
|                       | > mcg/mL              | mcg/mL               |
+-----------------------+-----------------------+----------------------+
| \(3\) Presence of     | > Greater than or     | Chromium (VI)        |
| Chromium (VI)         | > equal to            | concentration        |
|                       | >                     |                      |
|                       | > 50 mcg/mL           | greater than or      |
|                       |                       | equal to the Level   |
|                       |                       | of Detection (LOD)   |
+-----------------------+-----------------------+----------------------+
| \(4\) Presence of     | > Greater than or     | Specific halogen     |
| Halogen               | > equal to 200 mcg/mL | concentration        |
|                       | > nitrite equivalent  |                      |
|                       | > cutoff              | greater than or      |
|                       | >                     | equal to the LOD     |
|                       | > OR                  |                      |
|                       | >                     |                      |
|                       | > 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    | Glutaraldehyde       |
| Glutaraldehyde        | >                     | concentration        |
|                       | > OR                  |                      |
|                       | >                     | greater than or      |
|                       | > Characteristic      | equal to the LOD     |
|                       | > immunoassay         |                      |
|                       | > response on drug    |                      |
|                       | > test                |                      |
+-----------------------+-----------------------+----------------------+
| \(6\) Presence of     | > Greater than or     | Pyridine             |
| Pyridine              | > equal to 200 mcg/mL | concentration        |
|                       | > nitrite equivalent  | greater than or      |
|                       | > cutoff              | equal to the LOD     |
|                       | >                     |                      |
|                       | > OR                  |                      |
|                       | >                     |                      |
|                       | > 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     | > Greater than or     | Greater than or      |
| Surfactant            | > equal to 100 mcg/mL | equal to 100 mcg/mL  |
|                       |                       |                      |
| (dodecylbenzene       |                       |                      |
| sulfonate-equivalent) |                       |                      |
+-----------------------+-----------------------+----------------------+
| \(8\) Presence of     | > Greater than or     | Greater than or      |
| other 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 § 40.96 is proposed to be added, to read as follows:

**§ 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        | **Initial Test**      | **Confirmation       |
| Category**            |                       | Test**               |
+-----------------------+-----------------------+----------------------+
| \(1\) Creatinine &    | Creatinine less than  | Creatinine less than |
| Specific Gravity      | 2 mg/dL and specific  | 2 mg/dL and specific |
|                       | gravity is greater    | gravity is greater   |
|                       | than 1.0010 but less  | than 1.0010 but less |
|                       | than 1.0200           | than 1.0200          |
|                       |                       |                      |
|                       | OR                    |                      |
+-----------------------+-----------------------+----------------------+
|                       | Specific gravity is   | Specific gravity is  |
|                       | less than or equal to | less than or equal   |
|                       | 1.0010 and creatinine | to 1.0010 and        |
|                       | is greater than or    | creatinine is        |
|                       | equal to 2 mg/dL      | greater than or      |
|                       |                       | equal to 2 mg/dL     |
+-----------------------+-----------------------+----------------------+
| \(2\) pH              | Greater than or equal | Greater than or      |
|                       | to 3 and less than    | equal to 3 and less  |
|                       | 4.5 using a           | than 4.5 using a pH  |
|                       | colorimetric pH test  | meter                |
|                       | or pH meter           |                      |
|                       |                       |                      |
|                       | OR                    |                      |
+-----------------------+-----------------------+----------------------+
|                       | Greater than or equal | Greater than or      |
|                       | to 9 and less than 11 | equal to 9 and less  |
|                       | using a colorimetric  | than 11 using a pH   |
|                       | pH test or pH meter   | meter                |
+-----------------------+-----------------------+----------------------+
| \(3\) Nitrite         | Greater than or equal | Greater than or      |
|                       | to 200 mcg/mL using a | equal to 200 mcg/mL  |
|                       | nitrite colorimetric  | but less than 500    |
|                       | test                  | mcg/ml using a       |
|                       |                       | different            |
|                       | OR                    | confirmatory test    |
+-----------------------+-----------------------+----------------------+
|                       | Greater than or equal | Greater than or      |
|                       | to the equivalent of  | equal to 200 mcg/mL  |
|                       | 200 mcg/mL nitrite    | but less than 500    |
|                       | using a general       | mcg/mL using the     |
|                       | oxidant colorimetric  | same general oxidant |
|                       | test                  | colorimetric test    |
|                       |                       |                      |
|                       | OR                    |                      |
+-----------------------+-----------------------+----------------------+
|                       | Greater than or equal | Greater than or      |
|                       | to the equivalent of  | equal to 200 mcg/mL  |
|                       | 200 mcg/mL using a    | but less than 500    |
|                       | general oxidant       | mcg/ml using a       |
|                       | colorimetric test     | different            |
|                       |                       | confirmatory test    |
+-----------------------+-----------------------+----------------------+
| \(4\) Chromium (VI)   | Greater than or equal | Greater than or      |
|                       | to 50 mcg/mL          | equal to 50 mcg/mL   |
|                       |                       | using the same       |
|                       | using a chromium (VI) | chromium (VI)        |
|                       | colorimetric test     | colorimetric test    |
+-----------------------+-----------------------+----------------------+
| \(5\) Halogen         | Greater than or equal | Greater than or      |
|                       | to the LOD using a    | equal to the LOD     |
|                       | halogen colorimetric  | using the same       |
|                       | test                  | halogen colorimetric |
|                       |                       | test                 |
|                       | OR                    |                      |
+-----------------------+-----------------------+----------------------+
|                       | 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                  | aldehyde test        |
|                       |                       |                      |
|                       | OR                    |                      |
+-----------------------+-----------------------+----------------------+
|                       | Characteristic        | Characteristic       |
|                       | immunoassay response  | immunoassay response |
|                       | on initial drug test  | on confirmatory drug |
|                       |                       | test                 |
+-----------------------+-----------------------+----------------------+
| \(7\) Oxidizing       | Greater than or equal | Greater than or      |
| Adulterant            | to 200 mcg/mL         | equal to 200 mcg/mL  |
|                       | nitrite-equivalent    | nitrite-equivalent   |
|                       | using a general       | using the same       |
|                       | oxidant colorimetric  | general oxidant      |
|                       | test                  | colorimetric test    |
|                       |                       |                      |
|                       | OR                    |                      |
+-----------------------+-----------------------+----------------------+
|                       | Greater than or equal | Greater than or      |
|                       | to 50 mcg/mL chromium | equal to 50 mcg/mL   |
|                       | (VI)-equivalent using | chromium             |
|                       | a general oxidant     | (VI)-equivalent      |
|                       | colorimetric test     | using the same       |
|                       |                       | general oxidant      |
|                       | OR                    | colorimetric test    |
+-----------------------+-----------------------+----------------------+
|                       | Greater than or equal | Greater than or      |
|                       | to the LOD halogen    | equal to the LOD     |
|                       | concentration using a | halogen              |
|                       | general oxidant       | concentration using  |
|                       | colorimetric test     | the same general     |
|                       |                       | oxidant colorimetric |
|                       |                       | test                 |
+-----------------------+-----------------------+----------------------+
| \(8\) Surfactant      | Greater than or equal | Greater than or      |
|                       | to 100 mcg/ml         | equal to 100 mcg/ml  |
|                       | dodecylbenzene        | dodecylbenzene       |
|                       | sulfonate-equivalent  | sulfonate-equivalent |
|                       | using a surfactant    | using a the same     |
|                       | colorimetric test     | surfactant           |
|                       |                       | colorimetric test    |
|                       | OR                    |                      |
+-----------------------+-----------------------+----------------------+
|                       | 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      | cannot be obtained.   | cannot be obtained.  |
| tests.                |                       |                      |
+-----------------------+-----------------------+----------------------+
| \(10\) Interference   | No interfering        | No interfering       |
| with the GC/MS drug   | substance can be      | substance can be     |
| confirmation 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\. § 40.97 is proposed to be amended by adding the words, "[and
Rejected for Testing]{.underline}" between "[Non-negative]{.underline}"
and "[results]{.underline}" at paragraph (b)(2) and by revising
paragraph (a) to read as follows:

**§ 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]{.underline}: 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]{.underline}: 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]{.underline} 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]{.underline}: 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\. § 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:

**§ 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.

\* \* \* \* \*

12\. § 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\. § 40.129 is proposed to be amended by revising the section heading
and paragraph (a)(5) to read as follows:

**§ 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 §§
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\. § 40.131 is proposed to be amended by revising the section heading
to read as follows:

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

\* \* \* \* \*

15\. § 40.133 is proposed to be amended by revising the section heading,
re-designating paragraphs (b) and (c) as (c) and (d), respectively,
revising them, and adding paragraph (b) to read as follows:

**§ 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?**

\* \* \* \* \*

\(b\) 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 § 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 § 40.163, and, for a cancelled-invalid result, at § 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\. § 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 "§ 40.133(c)" and adding
in its place "§ 40.133(d)" to read as follows

**§ 40.149 May the MRO change a verified drug test result?**

\* \* \* \* \*

17\. § 40.155 is proposed to be amended by adding paragraph (d) to read
as follows:

**§ 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]{.underline} 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\. § 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:

**§ 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 §§ 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 § 40.131.

\(3\) After explaining the limits of disclosure (see §§ 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 § 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 § 40.160
for determining if there is clinical evidence that the individual is an
illicit drug user.

\(5\) If the recollection was [not]{.underline} 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\. § 40.160 is proposed to be added to read as follows:

**§ 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 § 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.

\(1\) 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\. § 40.162 is proposed to be added to read as follows:

**§ 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 §40.159(f) when any verified
non-negative result is also invalid.

21\. § 40.171 is proposed to be amended by revising paragraph (a) to
read as follows:

**§ 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\. § 40.177 is proposed to be amended by revising paragraph (d) to
read as follows:

**§ 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\. § 40.179 is proposed to be amended by revising the section to read
as follows:

**§ 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 § 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\. § 40.181 is proposed to be amended by revising the section to read
as follows:

**§ 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 § 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\. § 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:

**§ 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\. § 40.187 is proposed to be amended by revising the section to read
as follows:

**§ 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]{.underline}: 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]{.underline}: 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 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]{.underline}: 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 § 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 §§ 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]{.underline}: 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]{.underline}: 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 §40.163) to the employer and keep a copy for your records.
Transmit the document as provided in §40.167.

27\. §40.191 is proposed to be amended by re-designating paragraphs (c)
through (e) as (d) through (f), respectively, and adding paragraph (c)
to read as follows:

**§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\. § 40.197 is proposed to be amended by revising paragraph (c)(3),
re-designating paragraph (c)(4) as (c)(5), and adding paragraph (c)(4)
to read as follows:

**§ 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\. § 40.201 is proposed to be amended by revising paragraphs (c), (d),
and (e) to read as follows:

**§ 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).

\(d\) 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).

\* \* \* \* \*

30\. § 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)

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

[^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.