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Changes are Proposed to Federal Mandatory Substance Use Testing Guidelines

By Kathryn J. Russo
  • April 26, 2004

On April 13, 2004, the United States Department of Health and Human Services ("DHHS") announced a proposal to revise its Mandatory Guidelines for Federal Workplace Drug Testing Programs to establish guidelines for the testing of hair, oral fluid and sweat specimens for drugs, in addition to urine (the specimen that must be used under the current regulations). In addition, DHHS is proposing guidelines for using on-site tests to test urine and oral fluids at the collection site, requirements for certification of instrumental initial test facilities (i.e., local facilities that perform screening tests but not confirmatory tests), and added standards for collectors, on-site testers, and medical review officers, among other things.

The proposed rules would affect drug testing of approximately 400,000 federal employees, mainly in safety-sensitive and security-sensitive positions. However, they may impact private employers directly if they are adopted by the U.S. Department of Transportation ("DOT") for trucking and other regulated industries. The new rules also could pressure service providers to lower the prices they charge for laboratory tests, and give businesses greater flexibility in running their testing programs. Highlights of the proposed new rules are as follows.

Testing of Hair, Oral Fluid and Sweat Specimens

DHHS's proposed guidelines for testing of head hair, oral fluids and sweat articulate the procedures to be followed in collecting each type of specimen; the cut-off concentrations to be used to establish positive test results for each specimen type; the criteria to be used to establish adulterated, substituted and invalid test results; and the requirements for validity testing on all specimens, among other things.

Head Hair

DHHS is proposing that hair testing be included in the Federal Workplace Drug Testing Program for pre-employment, random, return-to-duty, or follow-up testing. Hair testing generally can detect drug usage within the past 90 days -- a much longer period in comparison to urine, sweat, or oral fluid. Hair is easily collected, transported and stored, and is more difficult to adulterate than urine.

Oral Fluids

DHHS proposes that oral fluids testing be permitted for pre-employment, random, reasonable suspicion/cause, or post-accident testing. Oral fluid is readily accessible and its collection is perceived as less invasive than a urine specimen collection. Oral fluid collections can easily be observed and, therefore, the specimen is less susceptible to adulteration or substitution. Drugs can be detected in oral fluids within one hour of use, making oral fluids useful in detecting very recent drug use.

Because oral fluid tests appear to be less accurate when testing for marijuana, DHHS proposes that a urine specimen be collected at the same time the oral fluid specimen is obtained, for the purpose of testing for marijuana if the oral fluid specimen is positive for marijuana.


DHHS proposes that sweat testing be permitted for pre-employment, random, reasonable suspicion/cause, post-accident, return-to-duty or follow-up testing. Sweat may be collected as liquid perspiration, on sweat wipes, or with a sweat patch. Sweat collection is non-invasive and commercially available sweat patches may be worn for an extended period of time. Unlike urine, head hair or oral fluid, the use of a sweat patch detects drug use that occurred shortly before the patch is applied and while the device remains applied to the skin. The window of detection for the sweat patch is for as long as the patch remains on the skin and is a cumulative measure of drug ingestion.

Additional Testing Locations

Use of On-Site Tests ("POCT"s)

Currently, DHHS Guidelines and DOT drug and alcohol testing regulations do not permit employers to conduct on-site testing. DHHS is proposing guidelines permitting the use of Point-of-Collection Tests ("POCT"s) for drugs. The main advantage of using a POCT is that it can be used anywhere and can provide quick negative test results (positive test results must be sent to laboratories for confirmatory testing). POCT testing of oral fluid or urine is most suited for situations requiring quick test results such as in emergency or crisis situations.

Use of Instrumental Initial Test Facilities ("IITF")

DHHS also proposes to include options for Instrumental Initial Test Facilities ("IITF"s) in its guidelines. An IITF is basically the screening part of a screening and confirmatory laboratory that is established in locations to meet special local testing needs more quickly and economically. The Notice of Proposed Rulemaking proposes that IITFs should:

  1. be at a permanent location;
  2. meet program forensic standards;
  3. participate in open and blind proficiency testing;
  4. have a rigorous quality assurance program;
  5. be subject to site inspections;
  6. use instrumented immunoassay tests for drugs which meet FDA requirements for commercial distribution;
  7. conduct required specimen validity tests;
  8. use DHHS cutoffs, and
  9. submit all non-negative specimens to a full service DHHS-certified laboratory for required additional testing.

Medical Review Officer Certification Requirements

DHHS proposes that Medical Review Officers ("MRO"s) be required to complete specific training requirements and to complete successfully an examination administered by a nationally recognized entity that certifies MROs, or by a subspecialty board for physicians performing a review of federal employee drug test results, which has been approved by the Secretary of DHHS. DHHS also proposes requirements for nationally recognized entities that seek approval from the Secretary to certify MROs, or for subspecialty boards for physicians performing a review of federal employee drug test results, to submit their qualifications and sample examination. Based on an annual review of the qualifications and content of the examination, the Secretary will publish annually a list of those entities and boards that have been approved in the Federal Register.

Individuals and organizations may submit comments on the Notice of Proposed Rulemaking by July 12, 2004.  

If you have any questions, would like to discuss the Notice of Proposed Rulemaking further, or desire assistance in submitting comments on the DHHS proposal, you may contact members of our Substance Abuse Practice Group.

©2004 Jackson Lewis P.C. This material is provided for informational purposes only. It is not intended to constitute legal advice nor does it create a client-lawyer relationship between Jackson Lewis and any recipient. Recipients should consult with counsel before taking any actions based on the information contained within this material. This material may be considered attorney advertising in some jurisdictions. Prior results do not guarantee a similar outcome.

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