[Code of Federal Regulations]
[Title 49, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 49CFR40.67]

[Page 610-611]
 
                        TITLE 49--TRANSPORTATION
 
          Subtitle A--Office of the Secretary of Transportation
 
PART 40_PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING 
PROGRAMS--Table of Contents
 
                  Subpart E_Urine Specimen Collections
 
Sec.  40.67  When and how is a directly observed collection conducted?

    (a) As an employer, you must direct an immediate collection under 
direct observation with no advance notice to the employee, if:
    (1) The laboratory reported to the MRO that a specimen is invalid, 
and the MRO reported to you that there was not an adequate medical 
explanation for the result;
    (2) The MRO reported to you that the original positive, adulterated, 
or substituted result had to be cancelled because the test of the split 
specimen could not be performed; or
    (3) The laboratory reported to the MRO that the specimen was 
substituted with a creatinine concentration greater than or equal to 2 
mg/dL and less than or equal to 5 mg/dL and the MRO reported the 
specimen to you as negative and dilute (see Sec. Sec.  40.145(a)(1) and 
40.197).
    (b) As an employer, you may direct a collection under direct 
observation of an employee if the drug test is a return-to-duty test or 
a follow-up test.
    (c) As a collector, you must immediately conduct a collection under 
direct observation if:
    (1) You are directed by the DER to do so (see paragraphs (a) and (b) 
of this section); or
    (2) You observed materials brought to the collection site or the 
employee's conduct clearly indicates an attempt to tamper with a 
specimen (see Sec. Sec.  40.61(f)(5)(i) and 40.63(e)); or
    (3) The temperature on the original specimen was out of range (see 
Sec.  40.65(b)(5)); or (4) The original specimen appeared to have been 
tampered with (see Sec.  40.65(c)(1)).
    (d)(1) As the employer, you must explain to the employee the reason 
for a directly observed collection under paragraph (a) or (b) of this 
section.
    (2) As the collector, you must explain to the employee the reason, 
if known, under this part for a directly observed collection under 
paragraphs (c)(1) through (3) of this section.

[[Page 611]]

    (e) As the collector, you must complete a new CCF for the directly 
observed collection.
    (1) You must mark the ``reason for test'' block (Step 1) the same as 
for the first collection.
    (2) You must check the ``Observed, (Enter Remark)'' box and enter 
the reason (see Sec.  40.67(b)) in the ``Remarks'' line (Step 2).
    (f) In a case where two sets of specimens are being sent to the 
laboratory because of suspected tampering with the specimen at the 
collection site, enter on the ``Remarks'' line of the CCF (Step 2) for 
each specimen a notation to this effect (e.g., collection 1 of 2, or 2 
of 2) and the specimen ID number of the other specimen.
    (g) As the collector, you must ensure that the observer is the same 
gender as the employee. You must never permit an opposite gender person 
to act as the observer. The observer can be a different person from the 
collector and need not be a qualified collector.
    (h) As the collector, if someone else is to observe the collection 
(e.g., in order to ensure a same gender observer), you must verbally 
instruct that person to follow procedures at paragraphs (i) and (j) of 
this section. If you, the collector, are the observer, you too must 
follow these procedures.
    (i) As the observer, you must watch the employee urinate into the 
collection container. Specifically, you are to watch the urine go from 
the employee's body into the collection container.
    (j) As the observer but not the collector, you must not take the 
collection container from the employee, but you must observe the 
specimen as the employee takes it to the collector.
    (k) As the collector, when someone else has acted as the observer, 
you must include the observer's name in the ``Remarks'' line of the CCF 
(Step 2).
    (l) As the employee, if you decline to allow a directly observed 
collection required or permitted under this section to occur, this is a 
refusal to test.
    (m) As the collector, when you learn that a directly observed 
collection should have been collected but was not, you must inform the 
employer that it must direct the employee to have an immediate 
recollection under direct observation.

[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001; 68 
FR 31626, May 28, 2003]