DHHS Proposed Rules

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

Notice of Interpretation:
April 22, 2002
Federal Register Vol. 67,
Pages 19615-19616
Primary Topic: FTA/USCG regulation applicability to ferry boats.
 

The information presented on this page should be used to update Chapter 7 of the revised Implementation Guidelines.
 

On April 13, 2004, the Substance Abuse and Mental Health Administration (SAMHSA) of the Department of Health and Human Services (DHHS) established standards for determining the validity of urine specimens collected under the Mandatory Guidelines for Federal Workplace Drug Testing Programs. These standards were published in the Federal Register Vol. 69, No. 71, pages 19644-19673. The standards were created to ensure that specimen validity testing (SVT) and reporting procedures are uniformly applied to all Federal agency urine specimens when a validity test is conducted.

Revised standards include, among other things, definitions of SVT related terms, SVT requirements, reporting requirements, clarification of MRO qualifications and responsibilities, donor challenge procedures and expansion of the existing performance-testing program and laboratory inspection program. Highlights of these revisions include:

• Validity tests are required on all specimens collected under the Mandatory Guidelines.
• Laboratory criteria were established to report a specimen as adulterated, substituted, invalid, or dilute. pH cutoff levels were established for adulterated specimens. Specific gravity and creatinine cutoff levels were established for substituted specimens. A substitute specimen is defined as one that has a creatinine concentration of less than 2 mg/dL and the specific gravity is less than or equal to 1.0010 or greater than or equal to 1.0200 on both the initial and confirmatory creatinine tests.
• The DHHS will begin including a list of known adulterants in the monthly Federal Register notices that list the laboratories that meet minimum standards to engage in urine drug testing for Federal agencies. The list will be revised as new adulterants are identified.

The revisions are consistent with the DOT Interim Final Rule (IFR) published in the Federal Register (Vol. 68, Pages 31624) on May 28, 2003 (See Updates, Issue 25, page 2) that established new dilute and substitute specimen criteria to be used for DOT mandated drug testing. However, the DOT IFR requires the MRO to define a specimen with a creatinine concentration below the cutoff levels (< 2 mg/dL) as substitute and requires the MRO to require the employer to send the employee for a retest under direct observation if the creatinine level is between 2 and 5 mg/dL. The revised Guidelines simplify the procedure by requiring the laboratories to report specimens below the newly established cutoff levels (< 2mg/dL) as substitute.

Even though the Mandatory Guidelines are established only for federal safety-sensitive employees eligible to be tested and does not directly address DOT/FTA covered employees, these standards are typically followed by the DOT. Consequently, the DOT is expected to publish a notice of proposed rulemaking (NPRM) by October and a final rule by November that incorporates these provisions in 49 CFR Part 40 making the DOT rule consistent with the Mandatory Guidelines for Federal Workplace Drug Testing Programs.
The new standards become effective on November 1, 2004. The only portion of the revised guideline that is open to further comment is the standard regarding the creatinine criteria for substitute specimens. Comments must be received by June 14, 2004 and must include the agency name and docket number (04-7985) of the rulemaking. Submissions to the docket must be made by e-mail at wvogl@samhsa.gov, fax at (301) 443-3031, or mail to 5600 Fishers Lane, Rockwall II, suite 815, Rockville, Maryland 20857.