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62276 Federal Register / Vol. 70, No.

209 / Monday, October 31, 2005 / Proposed Rules

An electronic version of the public • Web Site: http://dms.dot.gov. SVT would remain authorized but not
docket is available through EPA’s Follow the instructions for submitting required.
electronic public docket and comment comments on the DOT electronic docket On April 13, 2004, HHS published a
system, EPA Dockets. You may use EPA site. Federal Register notice revising its
Dockets at http://www.epa.gov/edocket/ • Fax: 1–202–493–2251. Mandatory Guidelines [69 FR 19644]
to view scientific views, access the • Mail: Docket Management Facility; with an effective date of November 1,
index listing of the contents of the U.S. Department of Transportation, 400 2004. Among the revisions contained in
official public docket, and to access Seventh Street, SW., Nassif Building, the HHS Mandatory Guidelines were the
those documents in the public docket Room PL–401, Washington, DC 20590– requirements that laboratories modify
that are available electronically. Once in 0001. substituted specimen and diluted
the system, select ‘‘search,’’ then key in • Hand Delivery: Room PL–401 on specimen testing and reporting criteria.
the appropriate docket identification the plaza level of the Nassif Building, HHS revised laboratory requirements for
number. 400 Seventh Street, SW., Washington, adulterated specimen testing. HHS also
2. Electronic Access. You may access DC, between 9 am and 5 pm, Monday required each Federal agency to conduct
this Federal Register document through Friday, except Federal specimen validity testing (SVT) to
electronically through the EPA Internet Holidays. determine if urine specimens collected
under the Federal Register listings at • Federal eRulemaking Portal: Go to under HHS Federal Workplace Drug
http://www.epa.gov/fedrgstr/. http://www.regulations.gov. Follow the Testing Programs have been adulterated
online instructions for submitting or substituted.
Dated: October 25, 2005. In an interim final rule (IFR) [69 FR
Brent Fewell,
comments.
Instructions: All submissions must 64865] published on November 9, 2004,
Acting Assistant Administrator Office of the DOT changed a number of items in
Water.
include the agency name and docket
number or Regulatory Identification part 40 to make part 40 and the HHS
[FR Doc. 05–21527 Filed 10–28–05; 8:45 am] Mandatory Guidelines consistent. We
Number (RIN) for this rulemaking. For
BILLING CODE 6560–50–P
detailed instructions on submitting did this to avoid conflicting
comments and additional information requirements that implementation of
on the rulemaking process, see the both rules would have had on
DEPARTMENT OF TRANSPORTATION Public Participation heading of the laboratories and medical review officers
Supplementary Information section of (MROs).
Office of the Secretary In the 2004 IFR, we indicated that we
this document. Note that all comments
received will be posted without change intended to fully address all aspects of
49 CFR Part 40 the HHS changes to their Mandatory
to http://dms.dot.gov. including any
[Docket OST–2003–15245] personal information provided. Please Guidelines in a notice of proposed
see the Privacy Act heading under rulemaking (NPRM). We also indicated
RIN 2105–AD55 that we would also take into
Regulatory Notices.
Docket: For access to the docket to consideration any subsequent HHS
Procedures for Transportation handbook materials (e.g., HHS MRO
Workplace Drug and Alcohol Testing read background documents or
comments received, go to http:// Manual) and update our cost figures for
Programs SVT in the context of making SVT
dms.dot.gov at any time or to Room PL–
AGENCY: Office of the Secretary, DOT. 401 on the plaza level of the Nassif mandatory. In this NPRM, we have
ACTION: Notice of proposed rulemaking. Building, 400 Seventh Street, SW., considered the HHS Guidelines as well
Washington, DC, between 9 am and 5 as the HHS MRO Manual, we propose
SUMMARY: The Department of pm, Monday through Friday, except to make SVT mandatory, and we have
Transportation is proposing to amend Federal Holidays. updated our cost figures accordingly.
certain provisions of its drug and In the 2004 IFR and an earlier IFR [68
FOR FURTHER INFORMATION CONTACT: Jim FR 31626] from May 28, 2003, we
alcohol testing procedures to change
L. Swart, Deputy Director (S–1), Office solicited comments regarding SVT and
instructions to laboratories, medical
of Drug and Alcohol Policy and substituted specimens. We will address
review officers, and employers with
Compliance, 400 Seventh Street, SW., the docket comments to both IFRs in
respect to adulterated, substituted,
Washington, DC 20590; telephone this preamble.
diluted, and invalid specimen results.
number 202–366–3784 (voice), 202–
These proposed changes are intended to Background
366–3897 (fax), or jim.swart@dot.gov (e-
create consistency with specimen
mail). We issued the 2003 IFR in order to
validity requirements established by the
U.S. Department of Health and Human SUPPLEMENTARY INFORMATION: respond to scientific and medical
Services and to modify some measures information suggesting we modify
Purpose
taken in two of our own interim final testing criteria for some specimens that
rules. This NPRM also proposes to make In its final rule of December 2000 [65 had been considered to be substituted
specimen validity testing mandatory FR 79526], the U.S. Department of and ultimately were treated as refusals
within the regulated transportation Transportation (DOT) made specimen to test. The 2003 IFR modified how
industries. validity testing (SVT) mandatory for the MROs would deal with any substituted
transportation industry contingent upon result with creatinine concentration
DATES: Comments to the notice of U.S. Department of Health and Human greater than or equal to 2 mg/dL. It did
proposed rulemaking should be Services (HHS) publishing its not change the HHS substitution criteria
submitted by December 30, 2005. Late- Mandatory Guidelines on SVT. In late that we had used.
filed comments will be considered to 2001, the DOT amended part 40 [66 FR In the 2004 IFR, we changed a number
the extent practicable. 41952, August 9, 2001] to remove the of items in part 40 to harmonize part 40
ADDRESSES: You may submit comments mandatory requirement because HHS and the new HHS Mandatory Guidelines
[identified by DOT DMS Docket Number had not finalized its Mandatory on SVT to avoid a number of
15245] by any of the following methods: Guidelines regarding SVT. We said that inconsistent requirements that the

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Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62277

application of both rules would likely procedures both for laboratories and recollections not under direct
have created for laboratories and MROs. MROs. Uniquely to part 40, we propose observation.
While the HHS Mandatory Guidelines ‘‘categories’’ of results in order to make There is also a difference between the
approach to substituted test results it easier for MROs to understand what HHS Mandatory Guidelines and this
allowed DOT to simplify its guidance to they are to do when verifying laboratory NPRM concerning how we intend to
MROs on how to deal with those results, results and reporting their verified address an MRO’s receiving a series of
there were several important items upon results. invalid test results from the same
which the 2004 IFR and the HHS 6. Regarding the numerous possible employee for the same testing event. If
Guidelines differed. The most important laboratory and MRO actions for split the employee presents two invalid
among them was the fact that SVT, specimens, we would generally adopt results for the same reason or when the
though authorized by part 40 and the HHS procedures both for laboratories employee has a long-term medical
IFR, was not yet required. and MROs. As with primary specimen condition that causes an invalid result,
The 2000 part 40 anticipated that results, we propose categories of split we propose a way to have MROs obtain
HHS would, sometime in 2001, amend results designed to make it easier for a negative result if one is needed for
its Mandatory Guidelines to establish MROs to verify and report results. pre-employment, return-to-duty, and
SVT requirements for HHS-certified 7. We propose to clarify that split follow-up testing. Also, we propose to
laboratories. When it appeared that HHS testing is still not offered for invalid have MROs deal with an invalid result
would not establish final SVT results. The HHS MRO Manual makes when the specimen is also positive,
requirements in 2001, we amended part this a clear point. substituted, and/or adulterated.
40 to remove the mandatory 8. We propose that if a second invalid For instance, the HHS MRO Manual
requirement. This was because we result (collected under direct directs MROs to report negative results
believed it was advisable to wait until observation) occurs but for a different if the initial invalid results and the
HHS completed its amendment before subsequent directly observed results are
reason than the first invalid result, the
making SVT mandatory throughout the invalid for the same reason. The DOT
verified result of the test event will be
transportation industries for all DOT will continue to consider these to be
a refusal. This is also consistent with
specimens. This NPRM proposes that cancelled tests because laboratories do
the HHS MRO Manual.
SVT be made mandatory, as the DOT not report invalid-negative results. If a
9. We propose to adopt HHS blind
said it intended to do in its final rule of negative result is needed because the
specimen certification criteria.
December 2000. testing event is pre-employment, return-
10. We propose to adopt HHS Semi- to-duty, or follow-up, the NPRM
Principal Policy Issues Annual Laboratory Report items. proposes to have the MRO determine if
While we have sought to harmonize there is clinical evidence that the
Harmonization With HHS our requirements with those of HHS, employee is an illicit drug user. We
In this NPRM we have sought to there remain a few issues for which we propose the same clinical evidence
harmonize our SVT proposals for have not proposed changes to determination if the employee has a
laboratories, MROs, and employers with procedures that were in the 2004 IFR or long-term medical condition that causes
the requirements contained in the HHS in part 40. Perhaps the most important the invalid result and needs a negative
Mandatory Guidelines and the HHS one is that we have not proposed to result. These clinical evidence
Medical Review Officer Manual. Here modify the requirement that MROs treat evaluations are proposed to be identical
are the most noteworthy of the laboratory reported negative-dilute to the evaluation currently required at
coordinated proposals: results with creatinine levels greater § 40.195 when an employee is unable to
1. We propose to make SVT than or equal to 2 mg/dL but less than provide a sufficient amount of urine
mandatory—like it is now with the HHS or equal to 5 mg/dL (hereafter ‘‘2–5mg/ because of a permanent or long-term
Federal employee testing program. dL range’’) as negative-dilutes that medical condition.
2. We would continue to utilize HHS require immediate recollections under Like HHS, we would have MROs
instructions to laboratories for direct observation. We also have not follow review procedures, as
establishing and directing laboratory proposed changes to the employer appropriate, for all laboratory reported
actions for SVT. We will also continue policy recollection option for other results and to report all verified results
to look to HHS for establishing negative-dilutes. By contrast, HHS treats to employers. But unlike HHS, we
appropriate cutoffs. An HHS-certified all negative-dilutes in the same propose having an exception that deals
laboratory’s testing equipment and SVT fashion—a Federal agency may collect with MROs reporting multiple results
parameters are all HHS-driven. Our the employee’s specimen under direct when one of them is invalid. The NPRM
proposed tables related to adulterated observation during the employee’s next would not require an MRO to report an
and invalid laboratory results are scheduled test event. invalid result if the MRO also verifies
primarily designed to explain and While we believe there are employees any other laboratory result for the
instruct HHS criteria rather than normally able to produce these 2–5 mg/ specimen as positive and/or refusal to
establish new criteria. dL range negative-dilute specimen test. MROs have told us it is problematic
3. We propose to modify some of our results, there are others who cannot for them to report cancelled-invalid
definitions and add a few new produce them without tampering with tests in conjunction with positives or
definitions in order to make them their specimens. We are also aware of refusals. MROs and employers have
consistent with HHS Mandatory challenges an employer faces in tracking questioned whether the required re-
Guidelines definitions. an employee’s test selection in order to collection under direct observation
4. We would continue to require have the next collection directly needs to take place.
laboratories to contact MROs when the observed, especially as time passes We have not proposed adopting the
laboratories find specific types of between testing events. Therefore, some HHS MRO Manual requirement that an
invalid results. negative-dilutes will continue to require MRO report a negative result if the
5. Regarding multiple results actions recollection under direct observation medical explanation for a substituted
and reporting for primary specimens, while others may continue to follow the specimen appears legitimate to the
we would generally adopt HHS employer policy options of immediate MRO. We believe that HHS has taken

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62278 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules

ample measures to accurately identify industry specimens were being tested the desire to have the DOT remedy the
substituted specimens by adjusting the for specimen validity in 2000. records of employees whose refusals to
creatinine concentration criteria Because employers are deeply test prior to May, 2003, had been the
laboratories need in order to report concerned about specimen tampering result of having substituted specimens.
specimens as substituted. Part 40 will and because HHS certification relies (in Their specific gravity levels had been in
continue to have MROs report these part) upon a laboratory’s ability to the substituted range, but their
verified results as cancelled, and report conduct SVT, we estimate that an even creatinine had apparently been in the 2–
their determinations and basis for them higher percentage of transportation 5 mg/dL range. At least two commenters
to us. If the DOT begins to receive industry specimens are undergoing SVT brought up issues totally unrelated to
reports that MROs are canceling now than in 2000. We estimate that 95% SVT.
substituted specimen results because of of industry specimens are undergoing
SVT, up from 80% in 2000. 2004 IFR Comments to the Docket
legitimate medical reasons, we would be
prepared to take measures needed for That higher percentage coupled with The comments to the November 9,
employees to obtain negative results the fact that fewer specimens are being 2004 IFR, especially those from
(when negatives are needed for pre- collected now than were collected in laboratories, were favorable about the
employment, return-to-duty, and follow- 2000, leads us to believe the increased DOT’s decision to take measures to align
up testing), perhaps by considering cost of requiring SVT for those part 40 with HHS SVT procedures. One
ways for MROs to determine if there is specimens not currently undergoing association requested that we go further
clinical evidence that an employee is an SVT will be even less than our 2000 cost with the alignment by making SVT
illicit drug user. estimate. There were 6.67 million mandatory rather than leaving it
industry tests conducted in 2005, down optional. One Third Party Administrator
Making SVT Mandatory from 7 million industry tests in 2000. (TPA) recommended that we provide
As we said in 2000, mandatory Therefore, we estimate that the cost of guidance on who (e.g., employer,
laboratory testing for specimen validity new SVT will be about $1 million, laboratory, TPA) makes the decision to
is an appropriate response to those who down from the $1.4 million figure authorize SVT.
estimated in 2000. Two MROs favored the DOT’s
would tamper with the DOT’s drug test
decision to keep their 2003 IFR
results. Again, we propose the same 2003 IFR Comments to the Docket requirement to order an immediate
position. It was the correct position in The comments to the May 28, 2003 recollection under direct observation
2000, and we think it is the correct IFR were generally supportive of the when a verified negative-dilute that
position now. Over the past several DOT’s decision to modify the creatinine contained creatinine in the 2–5 mg/dL
years, there have been an increasing levels required to call a substituted range. One of those MROs spoke about
number of products designed and specimen ‘‘a refusal to test.’’ Some what he considered the high rate of
marketed to adulterate specimens. supported the DOT’s diligence in positive results for those recollections.
Currently, there are more than 400 pursuing the subject of creatinine levels However, one employee association was
different products available for of substituted specimens, and a few opposed to the recollection requirement
adulterating specimens, although many others expressed the desire to do away for creatinine in the 2–5 mg/dL range.
contain the same component with SVT altogether. Another In fact, the association wanted the DOT
adulterants. There are also devices commenter said we were making an to do away with the below 2 creatinine
marketed with the promise to hide drug accommodation for a situation that was substitution criteria established by HHS,
use by substituting ‘‘clean’’ urine for a likely not to exist, so this commenter in essence wanting there to be no
drug user’s own urine. The cheating recommended that the DOT make no specimens considered substituted.
industry is real, and we must counter it. change with regard to substituted Additionally, the association also
Furthermore, cheating on a drug test specimen refusals. expressed a desire to have the DOT
through adulteration or substitution is a Most comments to the docket expunge the records of those employees
deliberate and direct attempt to thwart expressed, in one form or another, the with substitution refusals prior to May,
the testing process. Therefore, we are desire to have SVT laboratory standards 2003. Their specific gravity levels had
proposing to require SVT for all DOT developed and issued in final guidance been in the substituted range, but their
specimens. by HHS. That way, commenters creatinine had tested in the 2–5 mg/dL
In their Mandatory Guidelines, HHS reasoned, all laboratories would be range.
established SVT requirements with responsible for adhering to the SVT A laboratory requested that we require
which laboratories must comply in standards and would be held laboratories to report quantitative values
order to become and remain HHS- accountable for them. These on all dilutes (not just negative-dilutes)
certified. HHS has stated that their SVT commenters had a variety opinions because, in the event a positive-dilute
standards are designed to produce the related to the cutoff levels and testing was downgraded by the MRO, the
most accurate, reliable, and correctly ranges for SVT. Most indicated that they creatinine level would be important for
interpreted test results. Currently, when had provided similar comments to HHS the MRO to know. About negative-
DOT specimens are tested for validity, when it proposed SVT for the dilutes, one of the MROs suggested the
the SVT adheres to HHS procedural Mandatory Guidelines. A few category of dilute specimens having
standards. commenters discussed procedural creatinine above 5 mg/dL was
In 2000, we estimated an annual cost issues for MROs in dealing with superfluous to the process. He suggested
associated with SVT of about $1.4 substituted specimens with creatinine doing away with that category of dilute
million. At that time, a majority of HHS- in the 2–5 mg/dL range and with the results altogether.
certified laboratories were already period of time the IFR allowed for an One of the TPAs recommended the
conducting SVT. The larger laboratories, employee’s obtaining a required for Department find an easier way for
who were receiving the vast majority of medical evaluation. employers to determine which
transportation industry specimens, were Additionally, several comments (from laboratories use two SVT
all conducting SVT. These facts led us an employee, two employee methodologies, rather than one, so that
to estimate approximately 80% of associations, and an attorney) expressed the number of invalid results would be

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kept to a minimum. The TPA retesting of the primary specimen for mg/dL range and those refusals were
recommended that HHS amend its SVT if the split specimen fails to reported between September 1998 and
laboratory certification list to reconfirm a drug metabolite. In May 2003.
accommodate this request. Also, the addition, the Mandatory Guidelines For this discussion, there are several
TPA recommended that we use [for reflect the DOT’s desire (as made important time-lines and actions to take
example], ‘‘As an MRO, you must operational by the 2003 IFR) to change into consideration:
‘‘* * *’’ throughout part 40 as a means the creatinine criteria needed (in 1. In September 1998, HHS
of making it easier to figure out whose addition to the long-required specific established guidance regarding
actions are being directed. gravity criteria) to call a specimen laboratory testing requirements for
substituted. determining if a urine specimen should
DOT Response to the 2003 and 2004 IFR IFR issues related to a laboratory’s use be reported to the MRO as being
Comments to the Docket of two SVT methodologies versus one, substituted. Specimens had two testing
A major factor in the DOT’s decisions MRO and employer actions with criteria in order to be reported as
to withdraw part 40’s mandatory SVT negative-dilute specimens having substituted: The specimen’s creatinine
(in 2001) and to create the 2003 IFR creatinine in the 2–5 mg/dL range, and level must have been 5 mg/dL or less
regarding MRO actions on laboratory laboratories reporting creatinine values and the specimen’s specific gravity
reported substituted specimens was the for positive-dilute specimens are fully must have been less than or equal to
fact that HHS had not finalized or expanded in a later section called Other 1.001 or greater than or equal to 1.020.
updated SVT in their Mandatory NPRM Issues and Questions. 2. In December 2000, part 40
Guidelines. Likewise, our decisions to Regarding the 2004 IFR comment implemented procedures for MRO
establish the 2004 IFR—which served to asking us to clarify which persons or review and for split specimen testing for
bring part 40’s SVT more in-line with entities currently provide authorization SVT, to include substituted specimens.
the HHS—and to write this NPRM were for a laboratory to conduct SVT under Therefore, employees could show MROs
based upon the fact that HHS finalized the DOT program, the authorization that they had medical reasons for
and published its Mandatory Guidelines comes from part 40. Having said that, producing the result and proof they
effective November 1, 2004. until part 40 makes SVT mandatory could naturally produce substituted
The HHS Mandatory Guidelines have (rather than authorized), employers specimens. By doing so, their results
gone far toward alleviating many of the need to take active roles in determining would be cancelled.
concerns of the commenters. the SVT they want laboratories to 3. We issued the 2003 IFR so that
Specifically, IFR commenters explained conduct on their behalf. The contracts MROs would not treat substituted
that no mandatory SVT standards between employers and laboratories are specimens with creatinine
existed for laboratories to follow. They important. A laboratory needs to let concentration in the 2–5 mg/dL range as
were also concerned that the DOT employers know the SVT available to substituted specimens.
program operated with different SVT them and whether the laboratory uses 4. Nearly a year later, HHS revised
criteria than the HHS program. They two separate methodologies or one their Mandatory Guidelines with an
noted the laboratories were not certified when conducting SVT. The more effective date of November 1, 2004.
for their abilities to conduct SVT, and prudent employers will likely select a Among the revisions contained in the
that appropriate procedures and cutoff full range of SVT. The DOT appreciates HHS Mandatory Guidelines was the
criteria for SVT had not been the fact that most DOT-regulated requirement that laboratories modify
established by HHS. Under the new specimens are undergoing SVT and substituted specimen criteria. As a
HHS Mandatory Guidelines, HHS has would encourage employers to conduct result, there are no specimens with
set mandatory SVT standards. HHS the full range of SVT. creatinine levels greater than or equal to
certification depends upon laboratory Finally, the DOT views the NPRM as 2 mg/dL being reported by laboratories
SVT capabilities (among other things), an opportunity to consider our positions as substituted.
and HHS has established appropriate on SVT and propose modifications The question now is whether we
SVT reporting criteria and cutoff levels. accordingly. It was not our intention to should so do something about those
Nonetheless, there will continue to be conduct a full review of part 40. Nor employees who may have been
some disagreement between those who was it our intention to focus on issues incorrectly charged with refusing their
desire to have no SVT and those who that fall under the sole purviews of HHS drug tests because they had substituted
believe the established SVT criteria are Mandatory Guidelines (e.g., the contents specimens with creatinine in the 2–5
not stringent enough. However, we are of the HHS laboratory listing) and DOT mg/dL range. The answer is that we
proposing that all DOT specimens be agency regulations (e.g., the make-up of should.
tested for all SVT, and that those tests ‘‘actual knowledge’’ provisions). Consequently, the DOT will issue an
will follow procedures and cutoff Therefore, we have no responses to IFR Informational Notice, separately from
criteria established in the HHS comments addressing such topics. this NPRM, directing action on this
Mandatory Guidelines. We believe the matter. The notice permits employees to
HHS has presented well-reasoned DOT Response to 2003 and 2004 IFR present information to us showing that
Mandatory Guidelines and have, in the Comments Requesting That the they had a refusal to test before May
preamble to that document, forthrightly Department Rectify Past Substitution 2003. The reason for the refusal must be
explained their ongoing review and Refusals based upon the employee’s having a
analysis of SVT results and scientific In both the 2003 and 2004 IFRs, there substituted specimen result with a
criteria. were calls for the DOT to take action to creatinine concentration in the 2–5 mg/
Also, we believe the Mandatory rectify what several commenters dL range. Employees will also have to
Guidelines work well in harmonizing believed to be a mischaracterization of present proof that they are able to
with the 2000 part 40’s positions to some employee refusals to test. Some of produce such specimens by virtue of
make SVT mandatory, to grant the comments suggest that we take medical evaluations. If the DOT
employees the right of MRO review and measures to clear employee records of determines that an employee’s refusal
split specimen testing for SVT, and to refusals to test if their substituted fell within these parameters and the
provide (in certain instances) for the refusals showed creatinine in the 2–5 supporting documentation shows that

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62280 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules

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

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Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62281

reconfirm the primary results but is 2. Invalid result rates have risen not reported. Therefore, employers are
reported as adulterated. slightly and adulterated specimen rates not able to take the additional
9. Recollections—In §§ 40.197 and decreased slightly since HHS required recollection actions afforded other
40.201, we propose to change the laboratories to utilize two separate SVT negative-dilute specimen results.
regulation to clarify issues related to methodologies before they can report Should MROs have the same
recollections for dilute specimens, for results as adulterated. If the laboratory reporting responsibilities for
splits that are reported as invalid, and identifies the possible presence of downgraded negative-dilute results as
for a situation in which there is no split adulterant in a urine specimen using they have for any other negative-dilute
laboratory available to test the split one testing methodology, they will call result? Should employers have the same
specimen. the specimen invalid. This does not responsibilities to recollect under direct
10. Appendix Items—At Appendix B, apply to pH testing using a pH meter for observation when the creatinine
we propose to modify the semi-annual both the initial and confirmation tests. concentration is in the 2–5 mg/dL range
laboratory report so that it will have the Please provide us with your comments or the same recollection options if
same information required by the HHS on the benefits of requiring all creatinine is above 5 mg/dL?
Mandatory Guidelines. The three laboratories conducting DOT testing to 5. Realistic-looking prosthetic devices
proposed changes, while not dramatic, utilize two methodologies for SVT which hold and heat urine (or water
will help laboratories avoid needing two (except pH) or for directing employers mixed with powdered urine) are
different report formats, one for DOT to use only laboratories that employ two available for purchase and are known to
and one for HHS. We would also amend methodologies. What will be the have been used during observed
associated costs to laboratories and collections. They are available in a
some Appendix F citations so that they
employers for requiring laboratories to variety of colors making them difficult
will accurately reflect NPRM text
utilize two methodologies? to detect. We are interested in your
changes.
For invalid results, are required comments as to the appropriateness of
Other NPRM Issues and Questions recollections under direct observation having a collector make sure that the
1. MROs, TPAs, and collectors have timely enough to identify drug use? employee is not using a prosthetic
asked the Department to clarify issues of Before laboratories report invalid device during an observed collection.
results, are they contacting MROs (as For example, would it be appropriate
multiple results reporting. Multiple
required by the DOT and HHS) to to require that collectors and observers,
results can be reported by laboratories
discuss if sending the specimen to as appropriate, check for these devices
because of several reasons. For instance,
another HHS-certified laboratory will be by having male employees lower their
two collections (one unobserved, the
useful? pants and underwear just before
other observed) occur during the same
3. We propose no change to the 2004 observed collections take place? What
testing event because the first collection
IFR in the treatment of negative-dilute should be the consequence if a device
was out of temperature range or showed specimens with creatinine in the 2–5 is found?
signs of tampering; a primary specimen mg/dL range as needing to be
had multiple test results; or a test result Regulatory Analyses and Notices
recollected under direct observation.
was one that required a subsequent The result of the second specimen will The statutory authority for this rule
collection. continue to be the result of record even derives from the Omnibus
We believe the NPRM clearly if it is again negative-dilute. MROs have Transportation Employee Testing Act of
delineates our proposals for MRO informed us that a number of the 1991 (49 U.S.C. 102, 301, 322, 5331,
actions in multiple results situations recollected observed specimens have 20140, 31306, and 45101 et seq. and the
and would like to have your comment produced positive results. Some of the Department of Transportation Act (49
about them. However, we also want to reports we have received indicate that U.S.C. 322).
know your thoughts about the relative while some employees can normally This rule is not significant for
worth of continuing to have the produce specimens with creatinine in purposes of Executive Order 12866 or
collector send in two specimens (i.e., a the 2–5 mg/dL range, others cannot the DOT’s regulatory policies and
temperature out of range specimen or achieve those results without tampering procedures. It proposes modifications to
one that showed signs of tampering and with their specimens. We are interested our overall part 40 procedures and is
the subsequent observed specimen) in your comments as to whether the intended to further align our laboratory
instead of sending only the specimen DOT should continue to require and MRO procedures with those
collected under direct observation. recollection under direct observation for requirements that are being directed by
Do the complications caused by these negative-dilute results. HHS. Their economic effects will be
linking (or failure to link) the two Are the negative-dilute recollections negligible. Consequently, the DOT
collections outweigh the possibility that under direct observation yielding results certifies, under the Regulatory
the initial specimen will be non- that show employee drug use? Given the Flexibility Act, this rule will not have
negative while the observed specimen threat to public safety, what percentage a significant economic impact on a
will be negative or cancelled? What are of positive results on these recollections substantial number of small entities.
some of the complications employers would be considered too low to justify In the 2000 part 40, we estimated that
and MROs have experienced by having conducting them? approximately 80% of industry
two different results on the two 4. Neither DOT nor HHS has required specimens were being tested for SVT
specimens for the same testing event? laboratories to report numerical values and that the costs associated with
Can MROs report the verified results for for creatinine and specific gravity for making SVT mandatory would be about
two specimens for the same testing positive-dilute specimens, like we do $1.4 million annually. Current estimates
event on the same report? Do we simply for negative-dilute results. When MROs are that 95% of industry specimens are
need to make it clearer in part 40 that downgrade positive results to negative already undergoing SVT on a voluntary
a non-negative result(s) for one based upon legitimate medical reasons basis. This higher percentage, coupled
specimen takes precedence over a for these positive-dilute specimens, with the fact that fewer specimens are
negative or cancelled result for the other there is no additional MRO action being collected now than were collected
specimen? because the dilute numerical values are in 2000, leads us to believe the

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62282 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules

incremental cost of SVT for those test’’ in alphabetical order, all to read as other substances to oxidize drugs or
specimens not currently undergoing follows: drug metabolites to prevent the
SVT will be even less than our 2000 cost detection of the drug or drug
estimate. There were 6.67 million § 40.3 What do the terms in this regulation metabolites, or affects the reagents in
mean?
industry tests conducted in 2005, down either the initial or confirmatory drug
from 7 million industry tests in 2000.1 * * * * * test. Examples of these agents include,
Therefore, we estimate that the annual Adulterated specimen. A urine but are not limited to, nitrites,
cost of new SVT will be about $1 specimen containing a substance that is pyridinium chlorochromate, chromium
million. not a normal constituent or containing (VI), bleach, iodine, halogens,
Anyone is able to search the an endogenous substance at a peroxidase, and peroxide.
electronic form of all comments concentration that is not a normal
physiological concentration. * * * * *
received into any of our dockets by the Screening drug test. See Initial drug
name of the individual submitting the * * * * * test definition above.
comment (or signing the comment, if Confirmatory drug test. A second
analytical procedure to identify the * * * * *
submitted on behalf of an association, Substituted specimen. A specimen
business, labor union, etc.). You may presence of a specific drug or metabolite
with creatinine and specific gravity
review DOT’s complete Privacy Act which is independent of the initial test
values that are so diminished or so
Statement in the Federal Register and which uses a different technique
divergent that they are not consistent
published on April 11, 2000 (Volume and chemical principle from that of the
with normal human urine.
65, Number 70; Pages 19477–78) or you initial test in order to ensure reliability
may visit http://dms.dot.gov. and accuracy. (Gas chromatography/ * * * * *
mass spectrometry (GC/MS) is the only 4. Section 40.23 is proposed to be
List of Subjects in 49 CFR Part 40 authorized confirmation method for amended by revising paragraph (f)
Administrative practice and cocaine, marijuana, opiates, introductory text and adding paragraph
procedures, Alcohol abuse, Alcohol amphetamines, and phencyclidine). (f)(5), to read as follows:
testing, Drug abuse, Drug testing, Confirmatory validity test. A second § 40.23 What actions do employers take
Laboratories, Reporting and test performed on a different aliquot of after receiving verified test results?
recordkeeping requirements, Safety, the original urine specimen to further * * * * *
Transportation. support a validity test result. (f) As an employer who receives a
Dated: October 21, 2005. * * * * * drug test result indicating that the
Norman Y. Mineta, Dilute specimen. A urine specimen employee’s specimen was cancelled
Secretary of Transportation. with creatinine and specific gravity because it was invalid and that a second
values that are lower than expected for collection must take place under direct
49 CFR Subtitle A—Authority and human urine. observation—
Issuance
* * * * * * * * * *
For reasons discussed in the Initial drug test (also known as a (5) You must ensure that the collector
preamble, the Department of Screening drug test). An immunoassay conducts the collection under direct
Transportation proposes to amend part test to eliminate ‘‘negative’’ urine observation.
40 of Title 49 Code of Federal specimens from further consideration
* * * * *
Regulations, as follows: and to identify the presumptively 5. Section 40.83 is proposed to be
positive specimens that require amended by revising paragraph (g)(2) to
PART 40—PROCEDURES FOR confirmation or further testing.
TRANSPORTATION WORKPLACE read as follows:
Initial validity test. The first test used
DRUG AND ALCOHOL TESTING to determine if a urine specimen is § 40.83 How do laboratories process
PROGRAMS adulterated, diluted, or substituted. incoming specimens?
1–2. The authority citation for 49 CFR Invalid result. Refers to the result * * * * *
Part 40 continues to read as follows: reported by a laboratory for a urine (g) * * *
specimen that contains an unidentified (2) If the problem(s) is not corrected,
Authority: 40 U.S.C. 102, 301, 322, 5331, adulterant, contains an unidentified
20140, 31306, and 54101 et seq.
you must reject the test and report the
interfering substance, has an abnormal result in accordance with § 40.97(a)(3).
3. Section 40.3 is proposed to be physical characteristic, or has an * * * * *
amended by revising the definitions of endogenous substance at an abnormal 6–7. Section 40.89 is proposed to be
‘‘adulterated specimen,’’ ‘‘confirmation concentration that prevents the amended by revising paragraph (b) to
(or confirmatory) drug test,’’ laboratory from completing testing or read as follows:
‘‘confirmation (or confirmatory) validity obtaining a valid drug test result.
test,’’ ‘‘dilute specimen,’’ ‘‘initial drug * * * * * § 40.89 What is validity testing, and are
test,’’ ‘‘initial validity test,’’ ‘‘invalid Limit of Detection (LOD). The lowest laboratories required to conduct it?
result,’’ and ‘‘substituted specimen’’ and concentration at which an analyte can * * * * *
adding definitions for ‘‘limit of be reliably shown to be present under (b) As a laboratory, you must conduct
detection,’’ ‘‘non-negative specimen,’’ defined conditions. validity testing.
‘‘oxidizing adulterant,’’ and ‘‘screening 8. Section 40.95 and its heading are
* * * * *
Non-negative specimen. A urine proposed to be revised to read:
1 The lower number of tests may result from two

factors. First, the 2000 number was an estimate, specimen that is reported as adulterated, § 40.95 What are the adulterant cutoff
while the 2005 number is based on actual reporting. substituted, positive (for drug(s) or drug concentrations for initial and confirmation
It is possible that the 2000 number was on the high metabolite(s)), and/or invalid. tests?
side. Second, the operating administrations believe
that employment and turnover in some industries * * * * * (a) As a laboratory, you must use the
(e.g., the motor carrier industry) may have declined Oxidizing adulterant. A substance cutoff concentrations displayed in the
in recent years, resulting in fewer tests. that acts alone or in combination with following table for the initial and

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Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62283

confirmation adulterant tests. The table


follows:

Adulterant test Initial test Confirmation test

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

(b) As a laboratory, you must report the numerical values that support the § 40.96 What criteria do laboratories use to
results at or above the cutoffs (or for pH, adulterated result. establish that a specimen is invalid?
at or above or below the values, as 9. A new § 40.96 is proposed to be (a) As a laboratory, you must use the
appropriate) as adulterated and provide added, to read as follows: invalid test result criteria displayed in
the following table. The table follows:

Invalid test category Initial test Confirmation test

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

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62284 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules

Invalid test category Initial test Confirmation test

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 cannot be obtained ................................. Valid drug test cannot be obtained.
immunoassay drug tests.
(10) Interference with the No interfering substance can be identified ..................... No interfering substance can be identified.
GC/MS drug confirmation
assay.
(11) Physical appearance of
the specimen is such that
it may damage laboratory
equipment..
(12) Physical appearance of
Bottles A and B are clear-
ly different and Bottle A
result is as stated in 1
through 11, as appro-
priate, on this table..

(b) To obtain one of the invalid results (iii) Adulterated, with adulterant(s) confirmatory creatinine and specific
outlined at 1 through 10 of this table, as noted, with numerical values (when gravity tests, respectively.
a laboratory, you must use two separate applicable), and with remarks(s); * * * * *
aliquots—one for the initial test and (iv) Substituted, with numerical
another for the confirmation test. values for creatinine and specific § 40.105 [Amended]
(c) For a specimen having an invalid gravity; or 12. Section 40.105 is proposed to be
result for one of the reasons outlined at (v) Invalid result, with remark(s). amended by adding in paragraph (c) the
4 through 12 of this table, as a (3) Category 3: Rejected for Testing. words ‘‘adulterated, or substituted
laboratory, you must contact the MRO to When a specimen is rejected for testing, result’’ after the word ‘‘positive,’’ and
discuss whether sending the specimen as a laboratory you must report the before the word ‘‘you’.
to another HHS certified laboratory for result as being Rejected for Testing, with 13. Section 40.129 is proposed to be
testing would be useful in being able to remark(s). amended by revising the section
report a positive or adulterated result. heading and paragraph (a)(5) to read as
(d) As a laboratory, you must report * * * * *
follows:
the reason a test result is invalid. 11. Section 40.103 is proposed to be
10. Section 40.97 is proposed to be amended by removing the word ‘‘blank’’ § 40.129 What are the MRO’s functions in
amended by adding the words, ‘‘and and adding in its place the word reviewing laboratory confirmed non-
Rejected for Testing’’ between ‘‘Non- ‘‘negative’’ in paragraph (c) introductory negative drug test results?
negative’’ and ‘‘results’’ at paragraph text, by revising paragraphs (c)(1) (a) * * *
(b)(2) and by revising paragraph (a) to through (5), and removing paragraphs (5) Verify the test result, consistent
read as follows: (c)(6) to read as follows: with the requirements of §§ 40.135–
40.145, 40.159, and 40.160, as:
§ 40.97 What do laboratories report and § 40.103 What are the requirements for
(i) Negative; or
how do they report it? submitting blind specimens to a
laboratory? (ii) Cancelled; or
(a) As a laboratory, you must report (iii) Positive, and/or refusal to test
the results for each primary specimen. * * * * * because of adulteration or substitution.
The result of a primary specimen will (c) * * *
fall into one of three categories. They * * * * *
(1) All negative, positive, adulterated, 14. Section 40.131 is proposed to be
are as follows: and substituted blind specimens you
(1) Category 1: Negative Results. amended by revising the section
submit must be certified by the supplier heading to read as follows:
When a specimen is found to be and must have supplier-provided
negative, as a laboratory, you must expiration dates. § 40.131 How does the MRO or DER notify
report the test result as being one of the (2) Negative specimens must be an employee of the verification process
following, as appropriate: certified by immunoassay and GC/MS to after laboratory confirmed non-negative
(i) Negative, or contain no drugs. drug test results?
(ii) Negative-dilute, with numerical * * * * *
values for creatinine and specific (3) Drug positive blind specimens
must be certified by immunoassay and 15. Section 40.133 is proposed to be
gravity. amended by revising the section
(2) Category 2: Non-negative Results. GC/MS to contain a drug(s)/
metabolite(s) between 1.5 and 2 times heading, redesignating paragraphs (b)
When a specimen is found to be non- and (c) as (c) and (d), respectively,
negative, as a laboratory, you must the initial drug test cutoff concentration.
(4) Adulterated blind specimens must revising them, and adding paragraph (b)
report the test result as being one or to read as follows:
more of the following, as appropriate: be certified to be adulterated with a
(i) Positive, with drug(s)/metabolite(s) specific adulterant using appropriate § 40.133 Under what circumstances may
noted; confirmatory validity test(s). the MRO verify a test result as positive, or
(ii) Positive-dilute, with drug(s)/ (5) Substituted blind specimens must as a refusal to test because of adulteration
metabolite(s) noted, with numerical be certified for creatinine concentration or substitution, or as cancelled-invalid,
values for creatinine and specific and specific gravity to satisfy the criteria without interviewing the employee?
gravity; for a substituted specimen using * * * * *

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(b) As the MRO, you may verify a test (1) Obtain verification from the (4) If a negative result is required (i.e.,
result as cancelled-invalid (with collector that the recollection was pre-employment, return-to-duty, or
instructions to recollect immediately directly observed. follow-up tests), follow the procedures
under direct observation) without (2) If the recollection was directly at § 40.160 for determining if there is
interviewing the employee, as provided observed, report this result to the DER clinical evidence that the individual is
at § 40.159, if: as a negative-dilute result. an illicit drug user.
(1) The employee expressly declines (3) If the recollection was not directly (5) If the recollection was not directly
the opportunity to discuss the test with observed as required, do not report a observed as required, do not report a
you; result but again explain to the DER that result but again explain to the DER that
(2) If the DER has successfully made there must be an immediate recollection there must be an immediate recollection
and documented a contact with the under direct observation. under direct observation.
employee and instructed the employee 18. Section 40.159 is proposed to be (e) If the employee’s recollection
to contact you and more than 72 hours amended by revising paragraphs (a)(1) (required at paragraph (a)(5) of this
have passed since the time the DER through (3), adding paragraphs section) results in another invalid result
contacted the employee; or (a)(4)(iii), and (d) through (f) to read as for a different reason reported for the
follows: first specimen, as the MRO, you must
(3) If neither you nor the DER, after
making all reasonable efforts, has been report the test result as being a refusal.
§ 40.159 What does the MRO do when a
(f) If, as the MRO, you receive a
able to contact the employee within ten drug test is invalid?
laboratory invalid result in conjunction
days of the date on which you received (a) * * * with a positive, adulterated, and/or
the confirmed invalid test result from (1) Discuss the laboratory results with substituted result and you verify any of
the laboratory. the certifying scientist to determine if those results as being a positive and/or
(c) As the MRO, after you verify a test the primary specimen should be tested refusal to test, you do not report the
result as a positive or refusal to test or at another HHS certified laboratory. If cancelled-invalid result unless the split
as a cancelled-invalid result under this the laboratory did not carried out its specimen fails to reconfirm the result(s)
section, you must document the date requirements to contact you at of the primary specimen.
and time and reason, following the §§ 40.91(e) and 40.96(c), you must 19. Section 40.160 is proposed to be
instructions in § 40.163, and, for a contact the laboratory. added to read as follows:
cancelled-invalid result, at (2) If you and the laboratory have
§ 40.159(a)(5)(i). determined that no further testing is § 40.160 What does the MRO do when a
(d) As the MRO, after you have necessary, contact the employee and valid test result cannot be produced and a
verified a test result under this section inform the employee that the specimen negative result is required?
and reported the result to the DER, you was invalid. In contacting the employee, (a) If a valid test result cannot be
must allow the employee to present use the procedures set forth in § 40.131. produced and a negative result is
information to you within 60 days of the (3) After explaining the limits of required, (under § 40.159 (a)(4)(iii) and
verification documenting that serious disclosure (see §§ 40.135(d) and 40.327), (d)(4)), as the MRO, you must determine
illness, injury, or other circumstances you must determine if the employee has if there is clinical evidence that the
unavoidably precluded contact with the a medical explanation for the invalid individual is an illicit drug user. You
MRO and/or DER in the times provided. result. You should inquire about the must make this determination by
On the basis of such information, you medications the employee may have personally conducting, or causing to be
may reopen the verification, allowing taken. conducted, a medical evaluation and
the employee to present information (4) * * * through consultation with the
concerning whether there is a legitimate (iii) If a negative test result is required employee’s physician (if appropriate).
medical explanation of the confirmed and the medical explanation concerns a (b) If you do not personally conduct
test result. situation in which the employee has a the medical evaluation, as the MRO, you
permanent or long-term physiological or must ensure that one is conducted by a
16. Section 40.149 is proposed to be
anatomic abnormality that precludes licensed physician acceptable to you.
amended by revising the section
him or her from providing a valid (c) For purposes of this section, the
heading, removing the words ‘‘positive
specimen, as the MRO, you must follow MRO or the physician conducting the
or refusal to test’’ in paragraph (a), and
the procedures outlined at § 40.160 for evaluation may conduct an alternative
removing, in paragraph (a)(1), the
determining if there is clinical evidence test (e.g., blood) as part of the medically
reference to ‘‘§ 40.133(c)’’ and adding in
that the individual is an illicit drug appropriate procedures in determining
its place ‘‘§ 40.133(d)’’ to read as
user. clinical evidence of drug use.
follows:
* * * * * (d) If the medical evaluation reveals
§ 40.149 May the MRO change a verified (d) If the employee’s recollection no clinical evidence of drug use, as the
drug test result? (required at paragraph (a)(5) of this MRO, you must report the result to the
* * * * * section) results in another invalid result employer as a negative test with written
17. Section 40.155 is proposed to be for the same reason reported for the first notations regarding the medical
amended by adding paragraph (d) to specimen, as the MRO, you must: examination. The report must also state
read as follows: (1) Obtain verification from the why the medical examination was
collector that the recollection was required (i.e., either the basis for the
§ 40.155 What does the MRO do when a directly observed. determination that a permanent or long-
negative or positive test result is also (2) If the recollection was directly term medical condition exists or
dilute? observed, document that the employee because the recollection under direct
* * * * * had another specimen with an invalid observation resulted another invalid
(d) If the employee’s recollection result. result for the same reason, as
under direct observation, in paragraph (3) Follow the recording and reporting appropriate) and for the determination
(c) of this section, results in another procedures at (a)(4)(i) and (ii) of this that no signs and symptoms of drug use
negative-dilute, as the MRO, you must: section. exist.

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(1) Check ‘‘Negative’’ (Step 6) on the § 40.159(f)when any verified non- just as you would do for a primary
CCF. negative result is also invalid. specimen.
(2) Sign and date the CCF. 21. Section 40.171 is proposed to be (b) In addition, if the test fails to
(e) If the medical evaluation reveals amended by revising paragraph (a) to reconfirm validity criteria reported in
clinical evidence of drug use, as the read as follows: the primary specimen, you may transmit
MRO, you must report the result to the the specimen or an aliquot of it for
employer as a cancelled test with § 40.171 How does an employee request a testing at another HHS-certified
written notations regarding results of test of a split specimen? laboratory that has the capability to
the medical examination. The report (a) As an employee, when the MRO conduct another reconfirmation test.
must also state why the medical has notified you that you have a verified 25. Section 40.183 is proposed to be
examination was required (i.e., either positive drug test and/or refusal to test amended by revising paragraph (a),
the basis for the determination that a because of adulteration or substitution, removing paragraph (b), and re-
permanent or long-term medical you have 72 hours from the time of designating paragraph (c) as paragraph
condition exists or because the notification to request a test of the split (b), to be read as follows:
recollection under direct observation specimen. The request may be verbal or
§ 40.183 What information do laboratories
resulted another invalid result for the in writing. If you make this request to report to MROs regarding split specimen
same reason, as appropriate) and for the the MRO within 72 hours, you trigger results?
determination that signs and symptoms the requirements of this section for a (a) As the laboratory responsible for
of drug use exist. Because this is a test of the split specimen. There is no testing the split specimen, you must
cancelled test, it does not serve the split specimen testing for an invalid report split specimen test results by
purposes of a negative test (i.e., the result. checking the ‘‘Reconfirmed’’ box and/or
employer is not authorized to allow the * * * * * the ‘‘Failed to Reconfirm’’ box (Step
employee to begin or resume performing 22. Section 40.177 is proposed to be 5(b)) on Copy 1 of the CCF, as
safety-sensitive functions, because a amended by revising paragraph (d) to appropriate, and by providing clarifying
negative test is needed for that purpose). read as follows: remarks using current HHS Mandatory
20. Section 40.162 is proposed to be Guidelines requirements.
added to read as follows: § 40.177 What does the second laboratory
do with the split specimen when it is tested * * * * *
§ 40.162 What must MROs do with multiple to reconfirm the presence of a drug or drug 26. Section 40.187 is proposed to be
verified results for the same testing event? metabolite? amended by revising the section to read
(a) If the testing event is one in which * * * * * as follows:
there was one specimen collection with (d) In addition, if the test fails to § 40.187 What does the MRO do with split
multiple verified non-negative results, reconfirm the presence of the drug(s)/ specimen laboratory results?
as the MRO, you must report them all drug metabolite(s) that were reported in As the MRO, the split specimen
to the DER. For example, if you verified the primary specimen, you may transmit laboratory results you receive will fall
the specimen as being positive for the specimen or an aliquot of it for into five categories. You must take the
marijuana and cocaine and as being a testing at another HHS-certified following action, as appropriate, when a
refusal to test because the specimen was laboratory that has the capability to laboratory reports split specimen results
also adulterated, as the MRO, you conduct another reconfirmation test. to you.
would report the positives and the 23. Section 40.179 is proposed to be (a) Category 1: The laboratory
refusal to the DER. amended by revising the section to read reconfirmed all or some of the primary
(b) If the testing event was one in as follows: specimen results.
which two separate specimen (1) As the MRO, you must report to
collections (e.g., a specimen out of § 40.179 What does the second laboratory
the DER and employee which result(s)
temperature range and the subsequent do with the split specimen when it is tested
to reconfirm an adulterated test result? was/were reconfirmed.
observed collection) were sent to the (2) In the case of a reconfirmed
laboratory, as the MRO, you must: (a) As the laboratory testing the split positive test(s) for drug(s) or drug
(1) If both specimens were verified specimen, you must test the split metabolite(s), the positive is the final
negative, report the result as negative. specimen for the adulterant detected in result.
(2) If either of the specimens was the primary specimen, using the criteria (3) In the case of a reconfirmed
verified negative and the other was of § 40.95, just as you would do for a adulterated or substituted result, the
verified non-negative(s), report the non- primary specimen. refusal to test is the final result.
negative result(s). For example, if you (b) In addition, if the test fails to (4) In the case of combination positive
verified one specimen as negative and reconfirm validity criteria reported in and refusal to test results, the final
other as a refusal to test because the the primary specimen, you may transmit result is both positive and refusal to test.
specimen was substituted, as the MRO the specimen or an aliquot of it for (b) Category 2: The laboratory failed to
you would report the only the refusal to testing at another HHS-certified reconfirm all of the primary specimen
the DER. laboratory that has the capability to results because, as appropriate, drug(s)/
(3) If both specimens were verified conduct another reconfirmation test. drug metabolite(s) were not detected;
non-negative, report all of the non- 24. Section 40.181 is proposed to be adulteration criteria were not met; and/
negative results. For example, if you amended by revising the section to read or substitution criteria were not met.
verified one specimen as positive and as follows: (1) As the MRO, you must report to
the other as a refusal to test because the the DER and the employee that the test
specimen was adulterated, as the MRO § 40.181 What does the second laboratory must be cancelled.
you would report the positive and the do with the split specimen when it is tested (2) As the MRO, you must inform
refusal results to the DER. to reconfirm a substituted test result? ODAPC of the failure to reconfirm using
(c) As an exception to paragraphs (a) (a) As the laboratory testing the split the format in Appendix D to this part.
and (b) of this section, as the MRO you specimen, you must test the split (3) In a case where the split failed to
must follow procedures at specimen using the criteria of § 40.93(b), reconfirm because the substitution

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criteria were not met because the split to determine if the primary specimen see § 40.163) to the employer and keep
specimen creatinine concentration was meets appropriate substitution criteria. a copy for your records. Transmit the
greater than 2mg/dL but less than or (B) Except that the request is for a test document as provided in § 40.167.
equal to 5mg/dL, as the MRO, you must, of the primary specimen and is being 27. Section 40.191 is proposed to be
in addition to steps at (b)(1) and (2) of made to the laboratory that tested the amended by redesignating paragraphs
this paragraph, direct the DER to ensure primary specimen, follow the (c) through (e) as (d) through (f),
the immediate collection of another procedures of §§ 40.153, 40.171, 40.173, respectively, and adding paragraph (c)
specimen from the employee under 40.179, 40.181, and 40.185, as to read as follows:
direct observation, with no notice given appropriate.
§ 40.191 What is a refusal to take a DOT
to the employee of this collection (C) As the laboratory that tests the
drug test, and what are the consequences?
requirement until immediately before primary specimen to reconfirm the
presence of the adulterant found in the * * * * *
the collection. (c) As an employee, if you have a
(c) Category 3: The laboratory failed to split specimen and/or determine that
recollection under direct observation
reconfirm all of the primary specimen the primary specimen meets appropriate
because of an invalid test result and the
results, and also reported that the split substitution criteria, report your result
MRO reports the result of the observed
specimen was invalid, adulterated, and/ to the MRO on a photocopy (faxed,
specimen as being invalid for a different
or substituted. mailed, scanned, couriered) of Copy 1 of
reason than the first specimen, you have
(1) In the case where the laboratory the CCF.
(D) If the test of the primary specimen refused to take a drug test.
failed to reconfirm all of the primary
specimen results and the split was reconfirms the adulteration and/or * * * * *
reported as invalid, as the MRO, you substitution finding of the split 28. Section 40.197 is proposed to be
must: specimen, as the MRO you must report amended by revising paragraph (c)(3),
(i) Report to the DER and the the result as a refusal to test as provided redesignating paragraph (c)(4) as (c)(5),
employee that the test must be cancelled in paragraph (a)(3) of this section. and adding paragraph (c)(4) to read as
and the reason for cancellation. (E) If the test of the primary specimen follows:
(ii) Direct the DER to ensure the fails to reconfirm the adulteration and/ § 40.197 What happens when an employer
immediate collection of another or substitution finding of the split receives a report of a dilute specimen?
specimen from the employee under specimen, as the MRO you must cancel * * * * *
direct observation, with no notice given the test, following procedures in (c) * * *
to the employee of this collection paragraph (b) of this section. (3) If the result of the test you directed
requirement until immediately before (d) Category 4: The laboratory failed the employee to take under paragraph
the collection. to reconfirm some but not all of the (b)(1) of this section is also negative and
(iii) Inform ODAPC of the failure to primary specimen results, and also dilute, you are not permitted to make
reconfirm using the format in Appendix reported that the split specimen was the employee take an additional test
D to this part. invalid, adulterated, and/or substituted. because the result was dilute.
(2) In the case where the laboratory (1) In the case where the laboratory (4) If the result of the test you directed
failed to reconfirm any of the primary reconfirmed one or more of the primary the employee to take under paragraph
specimen results, and the split was specimen result(s), as the MRO, you (b)(2) of this section is also negative and
reported as adulterated and/or must follow procedures in paragraph (a) dilute, you are not permitted to make
substituted, as the MRO, you must: of this section and: the employee take an additional test
(i) Contact the employee and inform (2) Report that the split was reported because the result was dilute. Provided,
the employee that the laboratory has also as being invalid, adulterated, and/ however, that if the MRO directs you to
determined that his or her split or substituted (as appropriate). conduct a recollection under direct
specimen is adulterated and/or (3) Inform the DER to take action only observation under paragraph (b)(1) of
substituted, as appropriate. on the reconfirmed result(s). this section, you must immediately do
(ii) Follow the procedures of § 40.145 (e) Category 5: The split specimen was so.
to determine if there is a legitimate not available for testing or there was no * * * * *
medical explanation for the laboratory split laboratory available to test the 29. Section 40.201 is proposed to be
finding of adulteration and/or specimen. amended by revising paragraphs (c), (d),
substitution, as appropriate. (1) As the MRO, you must report to and (e) to read as follows:
(iii) If you determine that there is a the DER and the employee that the test
legitimate medical explanation for the must be cancelled and the reason for the § 40.201 What problems always cause a
adulterated and/or substituted test cancellation. drug test to be cancelled and may result in
result, report to the DER and the (2) As the MRO, you must also direct a requirement for another collection?
employee that the test must be the DER to ensure the immediate * * * * *
cancelled; and inform ODAPC of the recollection of another specimen from (c) The split specimen failed to
failure to reconfirm using the format in the employee under direct observation, reconfirm all of the primary specimen
Appendix D to this part. with no notice given to the employee of results because drug(s)/drug
(iv) If you determine that there is not this collection requirement until metabolite(s) were not detected;
a legitimate medical explanation for the immediately before the collection. adulteration criteria were not met; and/
adulterated and/or substituted test (3) As the MRO, you must notify or substitution criteria were not met.
result, take the following steps: ODACP of the failure to reconfirm using You must follow the applicable
(A) Report the test to the DER and the the format in Appendix D to this part. procedures in 40.187(b) (no recollection
employee as a verified refusal to test. (f) For all split specimen results, as is required in this case, unless the
Inform the employee that he or she has the MRO you must: specimen creatinine concentration for a
72 hours to request a test of the primary (1) Enter your name, sign and date substituted specimen was greater than
specimen to determine if the adulterant (Step 7) of Copy 2 of the CCF. 2mg/dL but less than or equal to 5mg/
found in the split specimen also is (2) Send a legible copy of Copy 2 of dL—which requires recollection under
present in the primary specimen and/or the CCF (or a signed and dated letter, direct observation).

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62288 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules

(d) The split specimen failed to 7. Invalid Result (number) ADDRESSES: You may submit comments
reconfirm all of the primary specimen by any of the following methods:
results, and reported that the split Appendix F to Part 40—[Amended] • Web Site: http://dms.dot.gov.
specimen was invalid. You must follow 32. Appendix F to Part 40 is proposed Follow the instructions for submitting
the procedures in 40.187(c)(1) to be amended by removing the comments on the DOT electronic docket
(recollection under direct observation is references to § 40.187(a)–(f) and site.
required in this case). § 40.191(d) and adding in their place • Fax: 1–202–493–2251.
(e) The split specimen failed to § 40.187(a)–(e) and § 40.191(e), • Mail: Docket Management Facility;
reconfirm all of the primary specimen respectively. U.S. Department of Transportation, 400
results because the split specimen was Seventh Street, SW., Nassif Building,
[FR Doc. 05–21488 Filed 10–28–05; 8:45 am]
not available for testing or there was no Room PL–401, Washington, DC 20590–
BILLING CODE 4910–62–P
split laboratory available to test the 001.
specimen. You must follow applicable • Hand Delivery: Room PL–401 on
procedures in 40.187(e) (recollection the plaza level of the Nassif Building,
DEPARTMENT OF TRANSPORTATION
under direct observation is required in 400 Seventh Street, SW., Washington,
this case). Office of the Secretary DC, between 9 a.m. and 5 p.m., Monday
* * * * * through Friday, except Federal
49 CFR Part 71 Holidays.
§ 40.207 [Amended] • Federal eRulemaking Portal: Go to
30. Section 40.207 is proposed to be [OST Docket No. 2005–22114]
http://www.regulations.gov. Follow the
amended by removing, in paragraph RIN 2105–AD53 online instructions for submitting
(a)(3), the reference to ‘‘40.187(b)’’ and comments.
adding in its place ‘‘40.187(b)(3), (c)(1), Standard Time Zone Boundary in the Instructions: All submissions must
and (e)’’. State of Indiana include the agency name and docket
31. Appendix B to Part 40 is proposed number (OST Docket Number 2005–
to be amended by revising it to read as AGENCY: Office of the Secretary (OST),
Department of Transportation (DOT). 22114) or Regulatory Identification
follows: Number (RIN) (2105–AD53) for this
ACTION: Notice of proposed rulemaking.
Appendix B to Part 40—DOT Drug rulemaking. Note that all comments
Testing Semi-Annual Laboratory SUMMARY: DOT tentatively proposes to received will be posted without change
Report relocate the time zone boundary in to http://dms.dot.gov including any
Indiana to move St. Joseph, Starke, personal information provided. Please
The summary report shall contain the Knox, Pike, and Perry Counties from the see the Privacy Act heading under
following information: eastern time zone to the central time Regulatory Notices.
Reporting Period: (inclusive dates) zone at the request of the County Docket: For access to the docket to
Laboratory Identification: (name and address) Commissioners. We are tentatively not read background documents or
Employer Identification: (name; may include proposing to change the time zone comments received, go to http://
Billing Code or ID code) boundary to move Marshall, Pulaski, dms.dot.gov at any time or to Room PL–
C/TPA Identification: (where applicable; 401 on the plaza level of the Nassif
name and address)
Fulton, Benton, White, Carroll, Cass,
1. Specimen Results Reported (total number) Vermillion, Sullivan, Daviess, Dubois, Building, 400 Seventh Street, SW.,
By Type of Test Martin, and Lawrence Counties from the Washington, DC, between 9 a.m. and 5
(a) Pre-employment (number) eastern time zone to the central time p.m., Monday through Friday, except
(b) Post-Accident (number) zone based on the petitions from the Federal Holidays.
(c) Random (number) commissioners in these counties. If Public Hearings: In addition to the
(d) Reasonable Suspicion/Cause (number) additional information is provided that submission of written comments, an
(e) Return-to-Duty (number) indicates that the time zone boundary opportunity for oral comments will be
(f) Follow-up (number) should be drawn differently, either to provided at four public hearings in
(g) Type of Test Not Noted on CCF Jasper, Logansport, South Bend, and
(number)
include counties currently excluded or
2. Specimens Reported to exclude counties that are currently Terre Haute. These hearings will be
(a) Negative (number) included in this proposal, we will make chaired by a representative of DOT in
(b) Negative and Dilute (number) the change at the final rule stage of this November. We will publish the date and
3. Specimens Reported as Rejected for proceeding. time in a separate document that will be
Testing (total number) DATES: Any County Commissioners from posted in the docket and published in
By Reason the counties that have submitted the Federal Register.
(a) Fatal flaw (number) petitions who wish to provide The hearings will be informal and
(b) Uncorrected Flaw (number) will be tape-recorded for inclusion in
4. Specimens Reported as Positive (total
additional data to justify a change from
the eastern time zone to the central time the docket. The DOT representative will
number)
By Drug zone should do so by November 10, provide an opportunity to speak for all
(a) Marijuana Metabolite (number) 2005. Other comments should be those wishing to do so, to the greatest
(b) Cocaine Metabolite (number) received by November 30, 2005 to be extent possible. The hearing locations
(c) Opiates (number) assured of consideration. Comments will be accessible for persons with
(1) Codeine (number) received after that date will be disabilities. If you need a sign language
(2) Morphine (number) considered to the extent practicable. If interpreter, please let us know no later
(3) 6–AM (number) the time zone boundary is changed as a than one week before the hearing.
(d) Phencyclidine (number)
(e) Amphetamines (number)
result of this rulemaking, the effective FOR FURTHER INFORMATION CONTACT:
(1) Amphetamine (number) date would be no earlier than 2 a.m. Joanne Petrie, Office of the Assistant
(2) Methamphetamine (number) EST Sunday, April 2, 2006, which is the General Counsel for Regulation and
5. Adulterated (number) changeover from standard time to Enforcement, U.S. Department of
6. Substituted (number) daylight saving time. Transportation, Room 10424, 400

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