[Federal Register Volume 75, Number 186 (Monday, September 27, 2010)]
[Rules and Regulations]
[Pages 59105-59108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24038]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2010-0161]
RIN 2105-AE03


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: Interim Final rule.

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SUMMARY: The Department of Health and Human Services recently issued a 
new Federal Drug Testing Custody and Control Form for use in both the 
Federal employee and Department of Transportation drug testing 
programs. In order to accommodate the form's use within our 
transportation industry program, the Department is making a few 
necessary regulation changes in order for collectors, laboratories, and 
Medical Review Officers to know how to use the new form. The form's use 
is authorized beginning October 1, 2010. The Department is also making 
a technical amendment to its drug testing procedures. The purpose of 
the technical amendment is to add a provision of the rule which was 
inadvertently omitted from the final rule in August 2010.

DATES: The rule is effective October 1, 2010. Comments to this interim 
final rule should be submitted by October 27, 2010. Late-filed comments 
will be considered to the extent practicable.

ADDRESSES: To ensure that you do not duplicate your docket submissions, 
please submit them by only one of the following means:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting 
comments.
     Mail: Docket Management Facility, U.S. Department of 
Transportation, 1200 New Jersey Ave., SE., West Building Ground Floor 
Room W12-140, Washington, DC 20590-0001;
     Hand Delivery: West Building Ground Floor Room W12-140, 
1200 New Jersey Ave., SE., between 9 a.m. and 5 p.m., Monday through 
Friday, except Federal holidays. The telephone number is 202-366-9329;
    Instructions: You must include the agency name and docket number 
DOT-OST-2010-0161 or the Regulatory Identification Number (2105-AE03) 
for the rulemaking at the beginning of your comments. All comments 
received will be posted without change to http://www.regulations.gov, 
including any personal information provided.

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 [email protected] (e-mail).

SUPPLEMENTARY INFORMATION:

Background

    All urine specimens collected under the Department of 
Transportation (DOT) drug testing regulation, 49 CFR Part 40, must be 
collected using chain-of-custody procedures that incorporate the use of 
the Federal Drug Testing Custody and Control Form (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] 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. Recently, HHS announced the new CCF in the 
Federal Register [75 FR 41488] which has an effective date of October 
1, 2010.
    The following items in the revised CCF are worth noting for the DOT 
transportation industry drug testing program:
    (1) In Step 1 of the CCF, the Federal testing authorities--HHS; 
DOT; and Nuclear Regulatory Commission (NRC)--are noted, with further 
specificity for the DOT Agencies--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\--also noted;
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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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    (2) In Step 5A on Copy 1 of the CCF, the new drug analytes MDMA, 
MDA, and MDEA are added, as are ``[Delta]9-THCA'' after ``Marijuana 
Metabolite'' and ``BZE'' after ``Cocaine Metabolite'' to specify the 
drug analytes;
    (3) In Step 6 on Copy 2 of the CCF, a line has been included on 
which the Medical Review Officer (MRO) would write the drug for which a 
positive result is verified, and a new line item ``other'' was added to 
assist the MRO in documenting other ``refusal to test'' situations--for 
example, when there is no legitimate medical explanation for the 
employee providing an insufficient amount of urine;
    (4) In Step 7 on Copy 2 of the CCF, a box has been added for the 
MRO to check if the split specimen is reported as cancelled; and
    (5) On the reverse side of Copy 5--the ``Donor Copy''--of the CCF, 
are the revised instructions for completing the CCF.
    Because HHS sought and received comments on the form and its use, 
we seek only to receive comments on the actual implementation of the 
new CCF, and not on the form itself.
    In addition, the technical amendment is intended to address an 
omission which has been called to our attention since the publication 
of the Department's final rule in August 2010 [75 FR 49850] which was 
intended to create consistency with many of the new drug testing 
requirements established by HHS. Specifically, the HHS Guidelines 
require laboratories to report the concentration of the drug or drug 
metabolite for a positive result to the MRO. This was omitted from our 
rule text in the section that directs what laboratories are to report 
and how they are to report it. We have amended the rule text to reflect 
this requirement.

[[Page 59106]]

Implementation Guidance

    DOT-regulated employers and their service agents are authorized to 
begin use of the new CCF on October 1, 2010. However, we recognize 
there will be large supplies of old CCFs available after the start 
date. To avoid wasting the old forms, the Department will permit use of 
the old CCF until September 30, 2011. After this date, collectors and 
laboratories are not to use any of the old CCFs in the DOT testing 
program. The rule text has been changed to reflect this one-full-year 
transition period from old CCF to new CCF.
    However, when the old CCF is used on or before September 30, 2011, 
the collector will need to write in the specific DOT Agency under which 
the specimen is collected and must do so in the remarks section in Step 
2 on Copy 1 of the CCF. This DOT Agency designation is a new feature in 
the new CCF. So, if an old CCF is used and the employee's specimen is 
collected under, for example, authority of the FMCSA regulation, the 
collector will write in ``DOT--FMCSA'' in the remarks section in Step 2 
of the CCF.
    Likewise, when an old CCF is used on or before September 30, 2011, 
before transmitting a confirmed positive drug test for MDMA, MDA, or 
MDEA, as appropriate, to the MRO, the laboratory--in addition to 
checking the ``positive'' box--must write in the specific MDMA, MDA, or 
MDEA analyte in the ``Remarks'' section in Step 5-A of Copy 1 of the 
CCF.
    Like now, use of a CCF past its expiration date will not be a fatal 
flaw. Use of the old CCF after September 30, 2011, must be corrected 
using the procedures at Sec.  40.205(b)(2).
    Regarding the completion of the new Step 1-D of the CCF, the 
Department would like to emphasize that neither the employer nor the 
collector should find it difficult to complete this new data item. DOT-
regulated employers and their Consortium/Third Party Administrators (C/
TPAs) currently provide the collector and the collection site with 
specific instructions--the test reason, 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), among others. 
Adding one additional data element to what is already provided by 
employers or their C/TPAs to collectors should not prove significantly 
difficult. An employer and its C/TPA should be readily aware of the DOT 
Agency regulating the employee's safety-sensitive duties. We have added 
a new Sec.  40.14 to put into one place the items that employers and 
their C/TPAs have been routinely providing collectors, and if they have 
not been doing so, the information they should have always been 
providing collectors, in addition to this new requirement for DOT 
Agency designations.
    If the information in Step 1-D of the CCF is not completed, the 
laboratory will not delay testing the specimen and reporting the 
confirmed result to the MRO. Similarly, the MRO will not delay the 
medical review process and reporting the verified result to the 
employer. The Department believes 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. To reduce the potential failure of the collector to check 
the appropriate box in Step 1-D, the Department will permit the 
checkmark to be pre-printed in the appropriate box prior to the 
collection. We amended our rule text to reflect these situations.
    As more of the DOT Agencies go toward having employee drug testing 
violations reported to them, these designations will prove invaluable 
to the process.
    Regarding Step 6 of Copy 2 of the CCF, HHS provided more space for 
identifying the positive drug(s) and a new line item ``Other'' was 
added to assist the MRO in documenting other ``Refusal to Test'' 
situations--for example, when there is no legitimate medical 
explanation for the employee providing an insufficient amount of urine. 
In Step 7 of Copy 2 of the CCF, HHS added a box for ``Test Cancelled'' 
for the MRO to check when a test is cancelled if a split specimen fails 
to reconfirm. We amended our rule text to reflect these modifications. 
As a reminder to MROs, the ``Test Cancelled'' box should only be used 
when the split fails to reconfirm for all the results verified and 
reported for the primary specimen.
    In light of the modifications HHS made to Step 7 of Copy 2 of the 
CCF, we have taken this opportunity to incorporate into Sec.  40.187(f) 
rule text on how MROs are to document split specimen results. It is our 
understanding that MROs have been completing this section correctly 
even though the rule text did not instruct the MRO to check the 
``Reconfirmed'' and/or ``Failed to Reconfirm'' boxes. The amendment to 
Sec.  40.187(f) makes this a requirement.
    On the back of Copy 5--the ``Donor Copy''--of the CCF, the 
instructions to the collector on completing the CCF are revised and 
updated.

Regulatory Analyses and Notices

Authority

    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).

Administrative Procedure Act

    The Department has determined this rule may be issued without a 
prior opportunity for notice and comment because providing prior notice 
and comment would be unnecessary, impracticable, or contrary to the 
public interest. This rule will authorize DOT-regulated employers to 
use the CCF beginning October 1, 2010. Providing an opportunity for 
prior notice and comment would be unnecessary, and would seem 
redundant, because the public already had an opportunity to comment and 
did provide comments to HHS on the proposed CCF. In their Notice of 
Proposed Revisions to the Federal Custody and Control Form, HHS stated 
that the CCF is used for the Federal workplace drug testing program but 
also pointed out that ``* * * the Department of Transportation (DOT) 
requires its regulated industries to use the Federal CCF.'' [74 FR 
59196] Because many of the commenters were transportation industry 
employers, C/TPAs, and associations, we are confident they understood 
that the new CCF would be used in the DOT-regulated program. And, 
because the DOT utilizes the CCF for our drug testing program, the DOT 
and HHS collaborated in preparing the final CCF.
    Providing an opportunity for prior notice and comment would be 
impracticable because there is such a short time frame from when HHS 
published the new CCF [75 FR 41488] to its October 1, 2010 effective 
date. In addition, this Interim Final Rule makes minor procedural 
amendments to its rule text to merely reflect the changes to the 
revised CCF and a technical amendment to correct an inadvertent 
oversight from a prior rulemaking. For these reasons, the Department 
finds there is good cause to make the rule effective immediately.

Executive Order 12866 and Regulatory Flexibility Act

    This Interim Final Rule is not significant for purposes of 
Executive Order 12866 or the DOT's regulatory policies and procedures. 
The rule makes minor procedural amendments to its rule text to merely 
reflect the changes to the revised CCF and a technical

[[Page 59107]]

amendment to correct an inadvertent oversight. The use of the revised 
CCF does not increase costs on regulated parties because it authorizes 
regulated employers to continue using the old CCF for an additional 
twelve months, until September 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 will impose no 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.

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 20, 2010, at Washington, DC.
Ray LaHood,
Secretary of Transportation.

0
For reasons discussed in the preamble, the Department of Transportation 
amends Title 49 of the Code of Federal Regulations, Part 40, as 
follows:

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. A new Sec.  40.14 is added, to read as follows:


Sec.  40.14  What collection information must employers provide to 
collectors?

    As an employer, or an employer's service agent--for example a C/
TPA, you must ensure the collector has the following information when 
conducting a urine specimen collection for you:
    (a) Full name of the employee being tested.
    (b) Employee SSN or ID number.
    (c) Laboratory name and address (can be pre-printed on the CCF).
    (d) Employer name, address, phone number, and fax number (can be 
pre-printed on the CCF at Step 1-A).
    (e) DER information required at Sec.  40.35 of this part.
    (f) MRO name, address, phone number, and fax number (can be pre-
printed on the CCF at Step 1-B).
    (g) The DOT Agency which regulates the employee's safety-sensitive 
duties (the checkmark can pre-printed in the appropriate box on the CCF 
at Step 1-D).
    (h) Test reason, as appropriate: Pre-employment; Random; Reasonable 
Suspicion/Reasonable Cause; Post-Accident; Return-to-Duty; and Follow-
up.
    (i) Whether the test is to be observed or not (see Sec.  40.67 of 
this part).
    (j) (Optional) C/TPA name, address, phone, and fax number (can be 
pre-printed on the CCF).

0
3. In Sec.  40.23, paragraph (f)(4) is revised, to read as follows:


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

* * * * *
    (f) * * *
    (4) You must instruct the collector to note on the CCF the same 
reason (e.g., random test, post-accident test) and DOT Agency (e.g., 
check DOT and FMCSA) as for the original collection.
* * * * *

0
4. In Sec.  40.45, revise paragraphs (b) and (c)(3), 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 September 30, 2011, they may 
not use an expired CCF for DOT urine collections).
    (c) * * *
    (3) As an employer, in Step 1-D of the CCF you may preprint the box 
for the DOT Agency under whose authority the test will occur.
* * * * *

0
5. In Sec.  40.63, paragraph (e) is revised, to read as follows:


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

* * * * *
    (e) You must pay careful attention to the employee during the 
entire collection process to note any conduct that clearly indicates an 
attempt to tamper with a specimen (e.g., substitute urine in plain view 
or an attempt to bring into the collection site an adulterant or urine 
substitute). If you detect such conduct, you must require that a 
collection take place immediately under direct observation (see Sec.  
40.67) and complete Step 2 by noting the conduct in the ``Remarks'' 
line of the CCF and the fact that the collection was observed by 
checking the ``Observed'' box. You must also, as soon as possible, 
inform the DER and collection site supervisor that a collection took 
place under direct observation and the reason for doing so.

0
6. In Sec.  40.83, paragraph (a) is revised, to read as follows:


Sec.  40.83  How do laboratories process incoming specimens?

* * * * *
    (a) You are authorized to receive only Copy 1 of the CCF. You are 
not authorized to receive other copies of the CCF or any copies of the 
alcohol testing form.
* * * * *

0
7. In Sec.  40.97, paragraphs (a)(2)(i) and (ii), and (e)(1) are 
revised, to read as follows:


Sec.  40.97  What do laboratories report and how do they report it?

    (a) * * *
    (2) * * *
    (i) Positive, with drug(s)/metabolite(s) noted, with numerical 
values for the drug(s) or drug metabolite(s).
    (ii) Positive-dilute, with drug(s)/metabolite(s) noted, with 
numerical values for the drug(s) or drug metabolite(s) and with 
numerical values for creatinine and specific gravity;
* * * * *
    (e) * * *
    (1) You must provide quantitative values for confirmed positive 
drug test results to the MRO.
* * * * *

0
8. In Sec.  40.129, paragraph (c) is revised, to read as follows:


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

* * * * *
    (c) With respect to verified positive test results, place a 
checkmark in the ``Positive'' box in Step 6 on Copy 2 of the CCF, 
indicate the drug(s)/metabolite(s) verified positive, and sign and date 
the verification statement.
* * * * *


0
9. In Sec.  40.163:
0
a. Paragraph (c)(8) is amended by removing ``and''.
0
b. Paragraph (c)(9) is amended by removing the period at the end and 
adding ``; and'' in its place.
0
c. Paragraph (c)(10) is added.
    The addition reads as follows:

[[Page 59108]]

Sec.  40.163  How does the MRO report drug test results?

* * * * *
    (c) * * *
    (10) The DOT Agency, if noted on the CCF.
* * * * *


0
10. In Sec.  40.187, paragraph (f) is revised to read as follows:


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

* * * * *
    (f) For all split specimen results, as the MRO you must in Step 7 
of Copy 2 of the CCF:
    (1) Report split specimen test results by checking the 
``Reconfirmed'' box and/or the ``Failed to Reconfirm'' box, or the 
``Test Cancelled'' box, as appropriate.
    (2), Enter your name, sign, and date.
    (3) Send a legible copy of Copy 2 of the CCF (or a signed and dated 
letter, see Sec.  40.163) to the employer and keep a copy for your 
records. Transmit the document as provided in Sec.  40.167.


0
11. In Sec.  40.191, paragraph (d)(2) is revised, to read as follows:


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

* * * * *
    (d) * * *
    (2) As the MRO, you must note the refusal by checking the ``Refusal 
to Test'' box in Step 6 on Copy 2 of the CCF, checking whether the 
specimen was adulterated or substituted and, if adulterated, noting the 
adulterant/reason. If there was another reason for the refusal, check 
``Other'' in Step 6 on Copy 2 of the CCF, and note the reason next to 
the ``Other'' box and on the ``Remarks'' lines, as needed. You must 
then sign and date the CCF.
* * * * *


0
12. In Sec.  40.193, paragraph (d)(2)(i) is revised, to read as 
follows:


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

* * * * *
    (d) * * *
    (2) * * *
    (i) Check the ``Refusal to Test'' box and ``Other'' box in Step 6 
on Copy 2 of the CCF and note the reason next to the ``Other'' box and 
on the ``Remarks'' lines, as needed.
* * * * *


0
13. In Sec.  40.203, paragraphs (d)(2) and (d)(3) are revised, to read 
as follows:


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

* * * * *
    (d) * * *
    (2) The certifying scientist's signature is omitted on Copy 1 of 
the CCF for a positive, adulterated, substituted, or invalid test 
result.
    (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-
September 30, 2011, you are not required to cancel a test because of 
the use of an expired CCF. Beginning October 1, 2011, if the problem is 
not corrected, you must cancel the test.


0
14. In Sec.  40.209, paragraphs (b)(1) and (b)(9) are revised, to read 
as follows:


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

* * * * *
    (b) * * *
    (1) A minor administrative mistake (e.g., the omission of the 
employee's middle initial, a transposition of numbers in the employee's 
social security number, the omission of the DOT Agency in Step 1-D of 
the CCF.)
* * * * *
    (9) Personal identifying information is inadvertently contained on 
the CCF (e.g., the employee signs his or her name on Copy 1); or
* * * * *


0
15. In Sec.  40.355, paragraph (l) is revised, to read as follows:


Sec.  40.355  What limitations apply to the activities of service 
agents?

* * * * *
    (l) In transmitting documents to laboratories, you must ensure that 
you send to the laboratory that conducts testing only Copy 1 of the 
CCF. You must not transmit other copies of the CCF or any ATFs to the 
laboratory.
* * * * *

[FR Doc. 2010-24038 Filed 9-24-10; 8:45 am]
BILLING CODE 4910-9X-P