[Federal Register Volume 65, Number 143 (Tuesday, July 25, 2000)]
[Notices]
[Pages 45815-45817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18904]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary


Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Notice.

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SUMMARY: This notice permits employers regulated by the Department of 
Transportation (DOT) to begin using a new Federal Drug Testing Custody 
and Control Form (CCF) as of August 1, 2000, provided they follow the 
procedures specified in this notice. Employers may also continue to use 
the current seven-part CCF. The Substance Abuse and Mental Health 
Services Administration (SAMHSA), Department of Health and Human 
Services (HHS) has revised the current CCF which has a July 31, 2000, 
expiration date. The Office of Management and Budget has approved the 
use of the new Federal CCF until July 31, 2003. Federal agencies are 
permitted to begin using the new Federal CCF on August 1, 2000, for 
their workplace drug testing programs.

[[Page 45816]]


EFFECTIVE DATE: August 1, 2000.

FOR FURTHER INFORMATION CONTACT: Don Shatinsky, Drug and Alcohol Policy 
Advisor, Office of Drug and Alcohol Policy and Compliance, Office of 
the Secretary, DOT, 400 7th Street, SW., Room 10403, Washington, DC 
20590, telephone number (202) 366-3784.

SUPPLEMENTARY INFORMATION:

Background

    All urine specimens collected under the DOT drug and alcohol 
testing rule (49 CFR Part 40) must be collected using chain of custody 
procedures to document the integrity and security of the specimen from 
the time of collection until receipt by the laboratory. To ensure 
uniformity of procedures among all Federal agencies and DOT regulated 
employers, the use of the Federal CCF is required. Based on the 
experiences of using the current Federal CCF for the past several 
years, DOT and HHS initiated a joint effort to develop a new Federal 
CCF that was easier to use and more accurately reflected both the 
collection process and how results were reported by the drug testing 
laboratories. This effort included scheduling two public meetings 
attended by over 35 industry representatives who recommended most of 
the changes to the current Federal CCF. As a result of these meetings, 
HHS published a proposed revised Federal CCF in the Federal Register 
(64 FR 61916) on November 15, 1999. Comments from the public were 
incorporated in a revised final form which was published in the Federal 
Register (65 FR 39155) on June 23, 2000, with an effective date of 
August 1, 2000.
    Major changes included eliminating two copies of the form so that 
the new Federal CCF now has five instead of seven copies. The new form 
moves the specimen bottle seals from the right side of the form to the 
bottom, simplifies the chain of custody step by requiring the collector 
to sign the form only once, provides a wider choice of terms that a 
laboratory can use to report results, allows the use of Copy 1 to 
report results of the split specimen testing, and places the Medical 
Review Officer (MRO) steps for both the primary and split specimens on 
the MRO copy of the form.
    To avoid inconsistencies with procedures established by HHS for the 
new CCF, the Department will parallel HHS guidance for the use of the 
new form. Issues dealing with transmission of alcohol information (DOT 
Breath Alcohol Testing Form) will be addressed in the final DOT drug 
and alcohol rule.

Implementation Guidance

    DOT-regulated employers may start to use the new Federal CCF 
starting August 1, 2000. There are changes associated with the use of 
the new CCF (e.g., Step 2, check box for Split, Single, or None 
Provided; check box for Observed) that must be followed even though 
they are not currently procedures required in 49 CFR Part 40. DOT-
regulated employers who chose to use the new CCF must ensure that the 
form is filled out completely. However, the procedures used in the 
urine specimen collection process, other than the use of the form, must 
still conform to the current requirements as directed in 49 CFR Part 
40. HHS published on their web site (www.health.org/workpl.htm) a new 
Urine Specimen Collection Handbook for Federal Workplace Drug Testing 
Programs and a new Medical Review Officer Manual for Federal Workplace 
Drug Testing Programs for use with the new CCF. This guidance and the 
MRO manual are only for Federal agency testing programs, not for DOT-
regulated transportation industry programs.
    The following are differences between the new HHS guidance and Part 
40. DOT-regulated parties must continue to use the Part 40 requirements 
except where otherwise noted:
    (1) The new HHS guidance directs the donor to empty his/her 
pockets. Current DOT guidelines permit the collector to make this 
request only if there is reason to believe that the donor has something 
in his/her pockets that may be used to adulterate a specimen (e.g., a 
bulging pocket).
    (2) The new HHS guidance tells the collector to initiate an 
immediate direct observation collection when a donor's conduct clearly 
indicates an attempt to substitute or adulterate a specimen. DOT rules 
require, in advance, the review and concurrence of a collection site 
supervisor or designated employer representative that the condition for 
a direct observation collection exists.
    (3) The new HHS guidance tells the collector to immediately begin a 
direct observation collection if the temperature is outside the 
acceptable range. DOT rules direct the collector to first offer to take 
the donor's body temperature. Direct observation collection is 
triggered only if the donor declines to provide a measurement of his/
her body temperature or the temperature varies by more than 1.8 deg. F 
from the temperature of the specimen.
    (4) The new HHS guidance permits Federal employees subject to drug 
testing to waive the split specimen requirement in a shy bladder 
situation. Under DOT rules, those individuals who are required to 
provide split specimens under modal administration rules, may not waive 
this requirement, but must provide a split specimen.
    (5) The new HHS guidance permits the collector to initiate a 
Arefusal to test@ procedure if the donor refuses to drink fluids as 
directed. Under current DOT rules, this is not considered a refusal.
    (6) Unlike the procedures in the new HHS guidance, DOT required 
collections conducted under direct observation are limited to current 
Part 40 requirements and to the September 28, 1998 MRO Guidance for 
Interpreting Specimen Validity Test Results memorandum signed by Mary 
Bernstein, Director, Office of Drug and Alcohol Policy and Compliance.
    (7) The new five-part CCF does not contain a shipping container 
seal, as does the current seven-part form. Collection sites may use 
separate collection container seals with the new CCF or may use the 
current process described in 49 CFR Part 40.25(h), which states, in 
part, ``* * * (shipping) containers shall be securely sealed to 
eliminate the possibility of undetected tampering with the specimen 
and/or the form. On the tape sealing the shipping container, the 
collection site person shall sign and enter the date specimens were 
sealed in the shipping container for shipment.'' Collection sites may 
utilize any appropriate adhesive material or packing tape provided the 
collection site person's signature and date may be affixed to the 
material used. Users of current seven-part CCF should continue to use 
the shipping container seals provided with these forms.
    Under the new HHS guidance, the laboratory may transmit all results 
(negative and non-negative) to the MRO by either faxing the completed 
Copy 1 of the CCF or transmitting a scanned image of the form via 
computer. Each method must be designed to ensure the confidentiality of 
the information, the security of the data transmission, and limit 
access to any data transmission, storage, and retrieval system. A 
laboratory may also continue to use the current method of sending a 
hard copy of the form. For all non-negative results, the laboratory 
must also send to the MRO a hard copy of the original Copy 1 of the 
CCF. Regulated parties in the DOT program may begin to follow this 
practice, though they are not required to do so. This practice is 
consistent with the Department's proposal in the Part 40 notice of 
proposed rulemaking, which most commenters favored.
    The Department will permit employers and laboratories to also use

[[Page 45817]]

the same process of transmitting the current seven-part CCF from the 
laboratory to the MRO:
    (1) A laboratory may send negative results by electronic (e.g., 
facsimile, imaging) transmission of Copy 1 of the seven part CCF to the 
MRO. For negative results, a hard copy (Copy 2) does not have to be 
sent to the MRO.
    (2) A laboratory may send non-negative results by electronic (e.g., 
facsimile, imaging) transmission of Copy 1 or Copy 2 of the seven part 
CCF to the MRO. A hard copy of the CCF must subsequently be sent to the 
MRO.
    Employers and service agents who provide DOT related drug and 
alcohol services must ensure that all current regulatory procedures 
related to drug testing, collection, record keeping, etc., are followed 
even if the option to use the new Federal CCF is initiated. 
Additionally, implementation of the new CCF and transmission of 
laboratory results of the new CCF or the current seven part CCF must 
have the concurrence of the employer and the employer's MRO. The 
Department is projecting the publication of a final drug and alcohol 
rule by the end of 2000 or the first part of 2001. At that time, the 
Department will address in more detail the various changes and options 
that will be implemented as a result of public input to the current 
NPRM.

    Issued this 21st day of July, 2000, at Washington, DC.
Mary Bernstein,
Director, Office of Drug and Alcohol Policy and Compliance, Department 
of Transportation.
[FR Doc. 00-18904 Filed 7-24-00; 8:45 am]
BILLING CODE 4910-62-U