What’s Ahead for Federal Drug Testing Programs

1. What’s Ahead for Federal Drug Testing Programs Drug Testing Advisory Board (DTAB) Initiatives in 2013 Presented by: Dr. Donna R. Smith Regulatory Affairs Officer, EDPM, Inc. dsmith@edpm.com

2. July 13 2011—DTAB Recommendations • Written recommendation to the SAMHSA administrator on including lab-based oral fluid testing for drugs of abuse in the Mandatory Guidelines • Written recommendation to the SAMHSA administrator on including additional Schedule II drugs (e.g. synthetic opiate/opioids) in the Mandatory Guidelines

3. Progress on July 2011 DTAB Recommendations • SAMSHA Administrator acceptance of DTAB recommendations—Jan 26, 2012 • Div. of Workplace Programs tasked with preparing notice of proposed revisions to the DHHS Guidelines • Documents prepared, however remain in SAMHSA/DHHS clearance process • Comment periods and review and evaluation of all comments • Expected to take at least 6 months after publication of the proposed DHHS Guideline changes • Revised Guidelines—2014 ?? • Implementation dates—2015 ?? • DOT must go through its own rulemaking process in order to adopt/modify/implement DHS changes in the DOT-regulated testing programs

4. SAMHSA & DTAB Initiatives in 2013 • Continued review of research projects and data on oral fluid testing and expanded opiates testing • Working groups convened to advise DWP on electronic CCF and MRO standards of practice • Teleconference meetings with RTI and DWP staff • Federal CCF renewal/extension and approval for eCCF • July 15, 2013, FR Notice, SAMHSA requested public comment on its proposal that the OMB approve use of a new Federal CCF and eCCF technology in federal workplace drug testing programs, with a proposed implementation date of September 1, 2013. • OMB continues to evaluate the privacy and security issues surrounding eCCF information collections. It has not approved the use of an eCCF • While they complete their review, OMB has authorized extending the use of the current 5-part carbonless manifold CCF, and it remains the only approved Federal CCF.

5. SAMHSA & DTAB Initiatives in 2013 • Evaluation of the scientific supportability of the hair specimen for Federal Workplace Drug Testing • Began in July 2013; expected to continue for approximately one year. • Review historical and current perspectives of hair testing for drugs of abuse • Perform exhaustive literature search • Identify unanswered questions about hair testing and conduct additional literature review, request for information, research studies, coordination on legal and public policy issues

6. Proposed Revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs • SAMHSA’s Division of Workplace Programs has prepared proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs • The proposed revisions would create separate Guidelines for each approved specimen/matrix: • Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid Specimens • Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine Specimens • If hair testing is recommended and approved for use in Federal Workplace Drug Testing Programs, a third Mandatory Guidelines would be created. • The Guidelines are parallel in their organization • The Mandatory Guidelines apply to Federal agencies in the Executive branch under the authority of Executive Order 12564

7. Expansion of drug panel in Urine Testing • Key components of proposed Mandatory Guidelines– Urine Specimens • Addition of synthetic opioids to existing HHS drug panel • Further synchronization with DOT Part 40 • Provisions to allow additional screening and confirmatory technologies • The proposed oral fluid Guidelines and the changes to the Urine Guidelines are “coupled” in the approval, submission and release process. Thus, no significant movement on getting expanded opiates testing in place for federal drug testing programs

8. DTAB Evaluation Process for Hair Testing • Review the historical and current perspective of hair as a drug testing matrix • Perform an exhaustive hair specimen literature search • Identify specific questions associated with hair testing issues that require in-depth discussion and further study • Deliberation on the scientific supportability based on the above • Make recommendations to SAMHSA administrator

9. Hair Testing • Key components of scientific review • Specimen characterization • Specimen collection • Preparation of specimen for testing • Stability—decomposition of compounds in hair • Target analytes • Cut-off concentrations • Initial/screening methods • Confirmation methods • Proficiency testing • Impact of hair color/pigmentation; external contamination and other exposures; hair dyes, processors, etc. • Appropriate use of hair testing in Federal programs

10. Positive Prevalence in Hair and Urine

11. Comparing Hair & Urine Testing • Positive prevalence rates for “paired” hair and urine specimens • “concordance” between hair and urine test results—same donor; same collection date • Data based on 193K paired collections Jan 2004-2009 tested at QDI laboratories • Pre-employment 73%, random 12%, other 15% • 5-drug panel (THC, COC, AMP, OPI, PCP) • Positive rates higher in hair than urine for most drugs • Both specimens detect some positives that the other does not

12. DOT Impact • DOT officially supported DTAB recommendations for oral fluid testing and expansion of DHHS drug testing panel to include synthetic opioids • DOT will have to prepare and publish revisions to 49 CFR Part 40 to incorporate any changes made to the Mandatory Guidelines • Process will be subject to the usual rulemaking procedures of proposed and final rule issuances • The motor carrier industry continues to press DOT for allowing the use of hair testing in DOT-mandated testing, especially for pre-employment testing