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Final Rule Makes Validity Testing Mandatory
On June 25, 2008, the Department of Transportation (DOT) published a final rule that amends 49 CFR Part 40 to make specimen validity testing mandatory. The rule that was published in the Federal Register, Volume 73, pages 35961–35975, will become effective on August 25, 2008. The rule change provides direction to collectors, laboratories, medical review officers, and employers regarding adulterated, substituted, diluted, and invalid urine specimen drug test results. The final rule (§40.89(b)) makes specimen validity testing mandatory for all DOT tests, including those conducted for employers covered by the Federal Transit Administration (FTA). Certified laboratories are required to follow the testing protocols for adulterated and invalid urine specimens that are established by the Department of Health and Human Services (HHS). The identity of adulterants tested for and the cutoff levels for adulterated or invalid test results are not included in the final rule as the DOT will follow the criteria established in the HHS Mandatory Guidelines. ![]() In an effort to make it more difficult to adulterate or substitute specimens, the final rule requires that specimens be collected under direct observation any time there is a specific reason to believe that any employee may be attempting to thwart the rule or has sufficient reason to evade the testing process. The conduct of observed collections for return-to-duty and follow-up drug testing will no longer be optional, but will be a required component of these testing circumstances (§40.67). The manner in which the observed collections will be performed is also described (see article on Page 2). The long list of potential test results reported by the laboratories and Medical Review Officers (MROs) was clarified and simplified. Additionally, the final rule expanded the definition of a test refusal to include an employee admission of adulteration or substitution during the MRO review process of an invalid test result. In addition, the MRO review process following an invalid test result for test categories requiring negative test results (i.e., pre-employment) was modified to allow MROs to accept medical evaluations ruling out signs and symptoms of drug use when employees/applicants have medical reasons for providing invalid results (§40.160). This procedure is consistent with the medical review process allowed for pre-employment testing circumstances when an individual has insufficient volume due to a long term or permanent disability. The final rule also requires laboratories to provide the DOT with semi-annual reports providing statistical summaries of their DOT testing results and provides a clarification of their blind specimen quality control measures to include adulterated and substituted specimens. For additional information regarding the rule change and its implication for employees, employers, and service agents, please refer to the articles provided on the following pages. |
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Specimen Validity Testing Definitions
Adulterated - A specimen is considered adulterated if it contains a substance that is not a normal constituent or contains an endogenous substance at a concentration that is not a normal physiological concentration. Diluted - Diluted specimens have creatinine and specific gravity values that are lower than expected for human urine. The HHS has determined that specimens with creatinine levels greater than or equal to 2.0 mg/dL but less than 20.0 mg/dL and have a specific gravity greater than 1.0010 but less than 1.0030 are dilute. Individuals with creatinine levels greater than or equal to 2.0 mg/dL but less than 5.0 mg/dL are required to be retested under direct observation. Substituted - Substituted specimens have creatinine and specific gravity values that are so diminished or so divergent that they are not consistent with normal human urine. The HHS has determined that specimens with creatinine levels of less than 2.0 mg/dL are substituted. Invalid - An invalid specimen is one that contains an unidentified adulterant, contains an unidentified interfering substance, has an abnormal physical characteristic, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing testing or obtaining a valid drug test result. |
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| Regulatory Clarification | Page 2 | Summer 2008 | |
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| For Your Information | Page 3 | Summer 2008 | |
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| Q & A/Common Audit Findings | Page 5 | Summer 2008 | |||||||||||||
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| Where to find...? 49 CFR Part 655, Prevention of Alcohol Misuse and Prohibited Drug Use in Transit Operations August 9, 2001 Federal Register Vol. 66, Pages 41996-42036 December 31, 2003 Federal Register Vol. 68, Pages 75455-75466 Primary Topic: One Page MIS Form November 30, 2006 Federal Register Vol. 71, Pages 69195-69198 Primary Topic: Applicability of FTA and USCG Regulations to Ferryboats January 9, 2007 Federal Register Vol. 72, Pages 1057-1058 Primary Topic: Revised Testing Rates 49 CFR Part 40, Procedures for Transportation Workplace Drug Testing Programs Revised: December 19, 2000 Federal Register Vol. 65, Pages 79462-79579 Primary Topic: Procedures for Transportation Workplace Drug and Alcohol Testing Program Revised Final Rule (49 CFR Part 40) July 25, 2003 Federal Register Vol. 68, Pages 43946-43964 Primary Topic: One-Page MIS Form January 22, 2004 Federal Register Vol. 69, Pages 3021-3022 Primary Topic: Expanded List of SAPs Technical Amendments August 1, 2001 Federal Register Vol. 66, Pages 41943-41955 Primary Topic: Clarifications and Corrections to Part 40; Common Preamble to Modal Rules Final Rule Change August 23, 2006 Federal Register Vol. 71, Pages 49382-9384 Primary Topic: Expanded List of SAP Qualifications Final Rule Change June 25, 2008 Federal Register Vol. 73, Pages 35961-35975 Primary Topic: Specimen Validity Testing Visit the ODAPC website at http://www.dot.gov/ost/dapc/ for a list of DHHS-certified testing facilities, conforming products lists for Evidential Breath Testing Devices (EBTs) and other useful information. |
Produced by: FTA-Office of Safety and Security 1200 New Jersey Avenue, SE 4th & 5th Floors- East Building Washington, D.C. 20590 Edited and Published by: USDOT-John A. Volpe National Transportation Systems Center Kendall Square Cambridge, MA 02142 Written by: RLS & Associates, Inc. 3131 South Dixie Highway Suite 545 Dayton, OH 45439 Illustrated by: Dan Muko |
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| Who Should Be Receiving This Update? In an attempt to keep each transit system well-informed, we need to reach the correct person within each organization. If you are not responsible for your system's Drug and Alcohol program, please forward this update to the person(s) who is and notify us of the correct listing. If you know of others who would benefit from this publication, please contact us at the address on the right to include them on the mailing list. This publication is free. |
RLS & Associates, Inc. 3131 South Dixie Highway Suite 545 Dayton, OH 45439 Phone: (937) 299-5007 Fax: (937) 299-1055 Email: rls@rlsandassoc.com |
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