Office of the Secretary, DOT.
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.Start Printed Page 45816
August 1, 2000.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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.
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° 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 Start Printed Page 45817the 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.Start Signature
Issued this 21st day of July, 2000, at Washington, DC.
Director, Office of Drug and Alcohol Policy and Compliance, Department of Transportation.
[FR Doc. 00-18904 Filed 7-24-00; 8:45 am]
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