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[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Rules and Regulations]
[Pages 59574-59578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24818]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2010-0161]
RIN 2105-AE13

Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs: Federal Drug Testing Custody and Control Form; Technical 
Amendment

AGENCY: Office of the Secretary, DOT.

ACTION: Final Rule; Technical Amendment.

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SUMMARY: On September 27, 2010, the U.S. Department of Transportation 
(DOT) published an interim final rule (IFR) authorizing the use of a 
new Federal Drug Testing Custody and Control Form (CCF) in its drug 
testing program. Use of the form is authorized beginning October 1, 
2010. This final rule responds to comments to the IFR and will finalize 
the authorization and procedures for using the new CCF for DOT-required 
drug tests. The intended effect of this final rule is to finalize the 
authority for use of the new CCF and to make a technical amendment to 
its drug testing procedures by amending a provision of the rule which 
was inadvertently omitted from a final rule in August 2010. The 
September 27, 2010 final rule was published under RIN 2105-AE03, 
however, it was inadvertently shown as a completed action on the Fall 
2010 Agenda; this action replaces RIN 2105-AE03.

DATES: The rule is effective September 27, 2011.

FOR FURTHER INFORMATION CONTACT: Bohdan Baczara, U.S. Department of 
Transportation, Office of Drug and Alcohol Policy and Compliance, 1200 
New Jersey Avenue, SE., Washington, DC 20590; 202-366-3784 (voice), 
202-366-3897 (fax), or bohdan.baczara@dot.gov (e-mail).

SUPPLEMENTARY INFORMATION: 

Background and Purpose

    All urine specimens collected under the DOT drug testing 
regulation, 49 CFR Part 40, must be collected using chain-of-custody 
procedures that incorporate the use of the CCF promulgated by the 
Department of Health and Human Services (HHS). On November 17, 2009, 
HHS published a proposal to revise the CCF [74 FR 59196]. In their 
proposal, HHS stated that the CCF is used for the Federal workplace 
drug testing program, but also pointed out that DOT ``* * *requires its 
regulated industries to use the Federal CCF'' [74 FR 59196]. Because 
many of the commentors to the HHS proposal were transportation industry 
employers, Consortia/Third-party Administrators (C/TPAs), and 
associations, the Department was confident the commentors understood 
the new CCF would be used in the DOT-regulated program. All the 
comments submitted were thoroughly reviewed by HHS and taken into 
consideration in fashioning the new CCF. The Department worked closely 
with HHS on the new CCF. HHS announced the new CCF in the Federal 
Register [75 FR 41488]. The CCF became effective date of October 1, 
2010.
    However, because of the short time frame between the HHS 
publication of the new CCF and its October 1, 2010 effective date, the 
Department did not have an opportunity to propose a rulemaking and 
therefore issued an Interim Final Rule (IFR) on September 27, 2010 [75 
FR 59105] authorizing DOT-regulated employers to also begin using the 
new CCF on October 1, 2010. The Department sought comments only on the 
actual implementation of the new CCF, and not on the form itself 
because HHS already sought and received comments on the form and its 
use because many of the commentors to the HHS proposal were 
transportation industry employers, C/TPAs, and associations. In the 
IFR, the Department made minor procedural amendments to the regulation 
to merely reflect the changes HHS made to the revised CCF, and 
clarified how collectors, laboratories, and medical review officers 
(MROs) must use the new form in the DOT regulated context. There were 
15 comments from four commentors.
    The Department is also making a technical amendment to address an 
omission in the rule text of a final rule published on August 16, 2010 
[75 FR

[[Page 59575]]

49850]. Specifically, we had removed the requirement in Sec.  40.121(d) 
for the MRO to complete continuing education units to satisfy the 
requalification training requirement but we failed to amend the 
definition of ``Continuing education'' in Sec.  40.3 to reflect this 
change. We do so in this Final Rule.

Section-by-Section Discussion

    The following part of the preamble discusses comments to each of 
the amended rule text sections.

Section 40.14 What collection information must employers provide to 
collectors?

    The Department added a new Sec.  40.14 to put into one section the 
information employers or their C/TPAs have been routinely providing 
collectors or should have been providing collectors; information such 
as, the reason for the test, whether the test is to be conducted under 
direct observation, the MRO name and address, and employee information 
(e.g., name and SSN or ID number), etc. All of this information would 
need to be provided in Step 1 of the CCF. Since a new Step 1-D was 
added to the CCF to specify which DOT Agency regulates the employee's 
safety-sensitive function, we included this among the information the 
employer or its C/TPA must provide to the collector.
    One commentor, a large laboratory with many collection sites, 
concurred with the requirement for employers or C/TPAs to ensure the 
collector has the necessary information to complete Step 1. The 
commentor went on to say that it relied on the employer or C/TPA to 
pre-mark the demographic information (e.g., test reason, testing 
authority) in Step 1 since its collection sites don't keep employer-
specific CCFs at their sites and the employee may not know this 
information. When the employer pre-marks this information, this helps 
ensure the information is completed correctly. The Department agrees. 
In the event Step 1 is not pre-marked, the employer would need to 
ensure the information is provided to the collector.
    Two commentors, apparently from the same collection site, were 
concerned that requiring the employer to provide the DOT Agency 
information would be confusing for the employers and that not knowing 
this information would delay the testing process. They stated ``* * * 
there are many instances when the employer has no idea if their donor 
is DOT or non-DOT'' and ``When inquiring of employers' DER to supply 
this information the majority of the responses are 'I don't know!' The 
Department also received several telephonic requests for clarification 
since October 1 in which collectors questioned how they would know this 
information if the employer didn't know it themselves.
    The Department believes the collector should never be put in a 
situation to determine the DOT Agency that regulates an employee's 
safety-sensitive functions. This is the employer's responsibility. 
Furthermore, the Department was surprised to hear that any employer 
currently regulated by DOT would not know which DOT Agency regulates 
it. We can only surmise this is a rare occurrence and there is no 
reason to believe it is a systemic problem. Perhaps it was because the 
employer forgot the specific abbreviation of its respective regulator: 
Federal Motor Carrier Safety Administration (FMCSA); Federal Aviation 
Administration (FAA); Federal Railroad Administration (FRA); Federal 
Transit Administration (FTA); Pipeline and Hazardous Materials Safety 
Administration (PHMSA); and the United States Coast Guard (USCG).\1\ 
Nevertheless, not knowing this fundamental concept raised serious 
concerns and compliance questions. For example: Is the employer subject 
to the DOT's drug and alcohol testing regulations? If the employer is 
covered by the DOT regulations, then other questions arise. Is the 
employer testing its employees at the proper random testing rates? Is 
the employer conducting post-accident tests when required? Is the 
employer providing the correct educational material to its employees as 
required by the DOT regulations? Is the employer appropriately filling-
out and submitting Management Information System (MIS) reports?
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    \1\ For purposes of following the requirements of 49 CFR Part 
40, ``DOT, The Department, DOT Agency'' is defined, at 40.3, to 
include the United States Coast Guard.
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    In response to the comment that employers do not know which DOT 
Agency regulates them or their employees' safety-sensitive functions, 
we encourage employers and their C/TPAs to review the guidance 
documents available to them on our site http://www.dot.gov/odapc and 
affirm their regulating DOT Agency. The Department is also providing 
the following to assist employers and C/TPAs with understanding these 
critical elements:

Federal Motor Carrier Safety Administration (FMCSA)

    Covered employee: A person who operates (i.e., drives) a Commercial 
Motor Vehicle (CMV) with a gross vehicle weight rating (gvwr) of 26,001 
or more pounds; or is designed to transport 16 or more occupants (to 
include the driver); or is of any size and is used in the transport of 
hazardous materials that require the vehicle to be placarded.

Federal Railroad Administration (FRA)

    Covered employee: A person who performs hours of service functions 
at a rate sufficient to be placed into the railroad's random testing 
program. Categories of personnel who normally perform these functions 
are locomotive engineers, trainmen, conductors, switchmen, locomotive 
hostlers/helpers, utility employees, signalmen, operators, and train 
dispatchers.

Federal Aviation Administration (FAA)

    Covered employee: A person who performs flight crewmember duties, 
flight attendant duties, flight instruction duties, aircraft dispatch 
duties, aircraft maintenance or preventive maintenance duties; ground 
security coordinator duties; aviation screening duties; and air traffic 
control duties. Note: Anyone who performs the above duties directly or 
by contract for a part 119 certificate holder authorized to operate 
under parts 121 and/or 135,  air tour operators defined in 14 CFR part 
91.147, and air traffic control facilities not operated by the 
Government are considered covered employees.

Federal Transit Administration (FTA)

    Covered employee: A person who performs a  revenue vehicle 
operation; revenue vehicle and equipment maintenance; revenue vehicle 
control or dispatch (optional); Commercial Drivers License non-revenue 
vehicle operation; or armed security duties.

Pipeline and Hazardous Materials Safety Administration (PHMSA)

    Covered employee: A person who performs on a pipeline or liquefied 
natural gas (LNG) facility an operation, maintenance, or emergency-
response function.

United States Coast Guard (USCG)

    Covered employee: A person who is on board a vessel acting under 
the authority of a license, certificate of registry, or merchant 
mariner's document. Also, a person engaged or employed on board a U.S. 
owned vessel and such vessel is required to engage, employ or be 
operated by a person holding a license, certificate of registry, or 
merchant mariner's document.
    Employers and their C/TPAs that may have DOT Agency-specific 
questions can find the DOT Agency drug and alcohol program manager 
contact

[[Page 59576]]

information at http://www.dot.gov/odapc/oamanagers.html.

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

    In paragraph (f)(4) of this section, we added the DOT Agency to the 
items an employer must instruct the collector to note on the CCF. There 
were no comments to this section.

Section 40.45 What form is used to document a DOT urine collection?

    In paragraph (b) of this section, we changed the date after which 
an expired CCF is not to be used and in paragraph (c)(3) of this 
section, we permitted employers to preprint the box of the DOT Agency 
under whose authority the test will occur. There were two comments to 
this section. One commentor thanked the Department for authorizing the 
use of the old CCF until September 30, 2011, stating the year-long 
transition to the new CCF would provide employers and their service 
agents ample time to deplete their stock of old CCFs. The other 
commentor pointed out that the old CCF expires November 30, 2011, and 
suggested that the inadvertent use of the old CCF be permitted until 
this date. The Department agrees with the commentor about extending the 
use of the old CCF until November 30, 2011 so that it coincides with 
the form's actual expiration date. We have amended the rule text to 
reflect this change, so that the use of an old CCF would be a flaw that 
would require correction after November 30, 2011.

Section 40.63 What steps does the collector take in the collection 
process before the employee provides a urine specimen?

    In paragraph (e) of this section we revised the rule text to 
provide the collector with specific instructions on completing Step 2 
of the CCF. One commentor concurred with this change. The same 
commentor asked for clarification that a collector's failure to note 
the DOT Agency in Step 1-D was not a flaw that would require the 
collector to contact the DER to obtain the missing information. See our 
response to Sec.  40.209.

Section 40.83 How do laboratories process incoming specimens?

    In paragraph (a) of this section we made a nomenclature change from 
``laboratory copy'' to ``Copy 1''. One commentor agreed with this 
change. The commentor wondered if DOT wanted laboratories to document 
the DOT Agency information from the CCF into their systems. We neither 
proposed that, nor will we require that.

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

    We revised paragraphs (a)(2)(i) and (ii), and (e)(1) of this 
section to require the laboratory to include the numerical values for 
the drug(s) or drug metabolite(s) in their report to the MRO. One 
commentor agreed with this change. The commentor wondered if DOT wanted 
laboratories to report the DOT Agency information from the CCF to the 
MRO. We neither proposed that, nor will we require that.

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

    In paragraph (c) of this section we revised the rule text with 
specific instructions to the MRO on completing Step 6 of Copy 2 of the 
CCF. There were no comments to this section.

Section 40.163 How does the MRO report drug test results?

    In paragraph (c)(10) of this section we required the MRO to 
indicate the DOT Agency on their written report to the employer if the 
DOT Agency is noted on the CCF. There were two comments to this change. 
One commentor asked for clarification on what action a MRO is to take 
if the DOT Agency is not noted on the CCF. The other commentor 
disagreed with the MRO including the DOT Agency on the result report to 
the employer for the following reasons: (1) The absence of the DOT 
Agency being marked on the CCF is not a flaw requiring corrective 
action, (2) some service agents may view the absence of the DOT Agency 
information as an item that requires corrective action by the 
collector, (3) there is no current requirement for the service 
provider's information system to capture this data element, (4) some 
service agents may view this change as a requirement for the laboratory 
to include the DOT Agency information on their electronic reports to 
the MRO, and (5) the DOT Agency information would be on the employer's 
copy of the CCF.
    Regarding the comment asking for clarification on what action a MRO 
is to take if the DOT Agency is not noted on the CCF, the MRO is not to 
delay the medical review process and report the verified result to the 
employer. As we said in the IFR, ``* * *the laboratory and MRO should 
note that the testing authority box was not checked and continue with 
processing, testing, verifying, and reporting the specimen result, as 
appropriate''. [75 FR 59106] Regarding the comment to not including the 
DOT Agency on the result report to the employer, we agree that the 
designation adds nothing to the employer's knowledge of the test 
outcome. We have removed the requirement from the rule text.

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

    In paragraph (f) of this section, we revised the rule text on how a 
MRO is to document split specimen test results. There were no comments 
to this section.

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

    In paragraph (d)(2) of this section we revised the rule text on how 
a MRO is to document a ``Refusal to Test''. There were no comments this 
section.

Section 40.193 What happens when an employee does not provide a 
sufficient amount of urine for a drug test?

    In paragraph (d)(2)(i) of this section we revised the rule text on 
how a MRO is to complete Step 6 on Copy 2 of the CCF when recording a 
``Refusal to Test''. There were no comments to this section.

Section 40.203 What problems cause a drug test to be cancelled unless 
they are corrected?

    In paragraph (d)(2) of this section we made a nomenclature change 
from ``laboratory copy'' to ``Copy 1''. In paragraph (d)(3) we revised 
the time period during which the use of an expired form would not cause 
the test to be canceled. One commentor did ``* * *not believe that use 
of an expired CCF should result in a cancelled test--especially in a 
post-accident testing situation.'' The commentor suggests, as they did 
in an earlier comment, that use of the old CCF be permitted until its 
expiration date of November 30, 2011 and that use after that date be 
considered a ``correctable flaw''. See our response to Sec.  40.45.

Section 40.209 What procedural problems do not result in the 
cancellation of a test and do not require corrective action?

    We revised paragraph (b)(1) of this section to say that omitting 
the DOT Agency in Step 1-D of the CCF would be an administrative 
mistake that would not result in the cancellation of a test and would 
not require corrective action. One commentor, a large laboratory, 
agreed that omitting the DOT Agency in Step 1-D of the CCF should be a 
mistake that would not require corrective action. Another commentor, a 
national

[[Page 59577]]

association, asked for clarification on what documentation a collector, 
laboratory, MRO or other person administering the drug testing process 
must maintain when the DOT Agency was not identified on the CCF.
    Another commentor, a large third party administrator, wanted to 
bring a discrepancy to our attention. Specifically, the commentor 
noticed a discrepancy between the title of this section in the IFR 
``What procedural problems do not result in the cancellation of a test 
and do not require corrective action?'' and the title of this section 
in the 2001 final rule [66 FR 41954] ``What procedural problems do not 
result in the cancellation of a test and do not require correction?''
    Regarding the comment asking for clarification on documenting the 
omission of the DOT Agency in Step 1-D, we believe the plain language 
of the rule text is self explanatory. Nevertheless, we will point out 
that laboratories and MROs should document this omission as they have 
been documenting similar omissions (the transposition of an employee's 
social security number or employer ID number) in the past. As we stated 
in the IFR, ``* * *the laboratory and MRO should note that the testing 
authority box was not checked and continue with processing, testing, 
verifying, and reporting the specimen result, as appropriate''. 
Furthermore, there is no requirement for the collector to provide a 
`memorandum for record' to anyone after the fact to indicate the DOT 
Agency. The regulation requires the employer to provide this 
information to the collector and the information is to be recorded on 
the CCF. As a reminder to MROs and employers, it is important for you 
to know the regulating DOT Agency since there may be DOT Agency 
specific requirements you must fulfill (e.g., reporting medical 
qualifications or non-negative results to a DOT Agency). Not complying 
with a DOT Agency's regulatory requirement because the DOT Agency want 
not indicated on the CCF does not mitigate your regulatory 
responsibilities.
    The Department would also like to remind employers, C/TPAs and 
collectors that although omitting the DOT Agency on the CCF would not 
cancel the test or require corrective action, this type of error may 
subject them to enforcement action under DOT Agency regulations or 
action under the Public Interest Exclusion if it becomes a recurring 
issue.
    Regarding the comment about the typographical discrepancy, the 
commentor is correct. However, we will leave the title of this section 
as printed in the IFR, because we believe it reads better and reflects 
the intent expressed in the 2001 preamble. [66 FR 41948]

Section 40.355 What limitations apply to the activities of service 
agents?

    In paragraph (l) of this section we made a nomenclature change from 
``laboratory copy'' to ``Copy 1''. One commentor asked for guidance on 
whether transmitting only Copy 1 to the laboratory is still applicable 
since collectors are being instructed by the laboratory to fax the MRO 
copy to a fax server at the lab.
    In this section, the Department only changed the nomenclature from 
``laboratory copy'' to ``Copy 1''. The requirement for collectors to 
send Copy 1 to the laboratory did not change.

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 54101 et seq.) and the Department of 
Transportation Act (49 U.S.C. 322).
    This final rule is not significant for purposes of Executive Order 
12866 or the DOT's regulatory policies and procedures. The rule 
finalizes the authorization and procedures for using the new CCF for 
DOT-required drug tests and makes a technical amendment to correct an 
inadvertent oversight in a previous rulemaking. This rule does not 
increase costs on regulated parties because it authorizes regulated 
employers to continue using the old CCF for an additional fourteen 
months, until November 30, 2011. After this date, the revised CCF must 
be used. This allows employers to use their current supply of old CCFs 
rather than discarding them. The rule does not impose new burdens on 
any parties. While small entities are among those who may use the 
revised CCF, the Department certifies, under the Regulatory Flexibility 
Act, that this rule does not have a significant economic impact on a 
substantial number of small entities.
    The Department finds good cause to make this rule final immediately 
upon publication. The basis of this determination is that, under the 
present interim final rule, drug tests recorded on the old version of 
the CCF would have to be cancelled beginning October 1, 2011. 
Laboratories and other program participants commented that because of 
the large numbers of old forms still being used, this date would result 
in large numbers of cancellations of otherwise valid tests. By making 
this rule change effective before October 1, the Department will 
prevent this unfortunate result and allow program participants to 
further exhaust stocks of the old version of the form for another four 
months. This will make program administration considerably smoother.

List of Subjects in 49 CFR Part 40

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

    Issued September 22, 2011, at Washington DC.
Ray LaHood,
Secretary of Transportation.

    Accordingly, the Interim Final Rule amending 49 CFR part 40 which 
was published at 75 CFR 59105 on September 27, 2010, is adopted as 
final with the following changes:

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

0
1. The authority citation for 49 CFR part 40 continues to read as 
follows:

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
54101 et seq.

0
2. In Sec.  40.3 revise the definition of ``Continuing education'' to 
read as follows:

Sec.  40.3  What do the terms used in this part mean?

* * * * *
    Continuing education. Training for substance abuse professionals 
(SAPs) who have completed qualification training and are performing SAP 
functions, designed to keep SAPs current on changes and developments in 
the DOT drug and alcohol testing program.
* * * * *

0
3. In Sec.  40.45, revise paragraph (b) to read as follows:

Sec.  40.45  What form is used to document a DOT urine collection?

* * * * *
    (b) You must not use a non-Federal form or an expired CCF to 
conduct a DOT urine collection. As a laboratory, C/TPA or other party 
that provides CCFs to employers, collection sites, or other customers, 
you must not provide copies of an expired CCF to these participants. 
You must also affirmatively notify these participants that they must 
not use an expired CCF (e.g., that after November 30, 2011, they must 
not use an expired CCF for DOT urine collections).
* * * * *

[[Page 59578]]

0
4. In Sec.  40.163:
0
a. Paragraph (c)(8) is amended by removing the semi-colon at the end 
and adding ``; and'' in its place.
0
b. Paragraph (c)(9) is amended by removing ``; and'' and adding a 
period in its place.
0
c. Remove paragraph (c)(10).

0
5. In Sec.  40.203, paragraph (d)(3) is revised, to read as follows:

Sec.  40.203  What problems cause a drug test to be cancelled unless 
they are corrected?

* * * * *
    (d) * * *
    (3) The collector uses a non-Federal form or an expired CCF for the 
test. This flaw may be corrected through the procedure set forth in 
Sec.  40.205(b)(2), provided that the collection testing process has 
been conducted in accordance with the procedures of this part in an 
HHS-certified laboratory. During the period of October 1, 2010-November 
30, 2011, you are not required to cancel a test because of the use of 
an old CCF. Beginning December 1, 2011, if the problem is not 
corrected, you must cancel the test.
* * * * *
[FR Doc. 2011-24818 Filed 9-26-11; 8:45 am]
BILLING CODE 4910-9X-P
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