PNNL-27318 Requiring Total Abstinence from Alcohol Consumption and Testing for EtG Technical Letter Report February 2018 ME Lerchen EP Kennedy AC Dalton Prepared for the U.S. Nuclear Regulatory Commission under an Interagency Agreement with the U.S. Department of Energy Contract DE-AC05-76RL01830 PNNL-27318 Requiring Total Abstinence from Alcohol Consumption and Testing for EtG Technical Letter Report ME Lerchen EP Kennedy AC Dalton February 2018 Prepared for the U.S. Nuclear Regulatory Commission under an Interagency Agreement with the U.S. Department of Energy Contract DE-AC05-76RL01830 Pacific Northwest National Laboratory Richland, Washington 99352 Abstract This report addresses clinical, scientific, regulatory, and legal considerations for requiring total abstinence from alcohol use for individuals employed in safety- and security-sensitive positions in regulated industries and professions. The report provides a conceptual framework for categorizing alcohol consumption and medical problems associated with drinking, and treatment options based on prevailing substance abuse professional opinions and practices. Based on discussions with experts from professional associations and certification authorities for substance abuse treatment and training programs, the report presents findings about professional opinions regarding treatment approaches and their scientific and empirical rationales. In addition, the report provides a discussion of alcohol metabolism and alcohol testing with regard to the validity and suitability of using ethyl glucuronide (EtG) testing for monitoring total abstinence compliance as well as potential challenges in accurately interpreting EtG results. The report offers an overview and discussion of the extent to which individuals with alcohol use disorders are protected by the extant laws and regulations and the current policies of regulatory and oversight agencies regarding workplace alcohol testing and abstinence requirements. The report concludes with summaries of the findings and a discussion of their implications for fitness-for-duty programs. iii Acknowledgments The Pacific Northwest National Laboratory project team gratefully acknowledges the guidance and assistance provided by Lawrence Criscione, U.S. Nuclear Regulatory Commission (NRC) Project Manager; Valerie Barnes of the NRC Office of Nuclear Regulatory Research; and Paul Harris of the NRC Office of Nuclear Security and Incident Response. We also thank Kristi Branch, Dr. Amoret Bunn, Ms. Eva Mart, and Ms. Fleur DePeralta for their insightful peer reviews. We appreciate the opportunity to have reviewed the information addressed in this report. The accuracy of the information and the views presented in this report are the responsibility of the authors and do not necessarily represent the opinion of the NRC or of any particular individuals or licensees. v Acronyms and Abbreviations 5-HIAA 5-hydroxyindole-3-acetic acid 5-HTOL 5-hydroxytryptophol AA Alcoholics Anonymous AAAP American Academy of Addiction Psychiatry ADA Americans with Disabilities Act ADAAA Americans with Disabilities Act Amendments Act ALT alanine amino transferase APA American Psychiatric Association ARG Alcohol Research Group ASAM American Society of Addiction Medicine AST aspartate amino transferase AUD alcohol use disorder AUDIT Alcohol Use Disorders Identification Test BAC blood alcohol concentration BAT breath alcohol technician CAS Center of Alcohol Studies CBA collective bargaining agreement CDT carbohydrate deficiency transferrin CESAR Center for Substance Abuse Research CFR Code of Federal Regulations CIHS Center for Integrated Health Solutions DHHS U.S. Department of Health and Human Services DOJ U.S. Department of Justice DOL U.S. Department of Labor DOT U.S. Department of Transportation DSM Diagnostic and Statistical Manual of Mental Disorders DUI driving under the influence DWI driving while intoxicated EAP employee assistance programs EEOC U.S. Equal Employment Opportunity Commission EtG ethyl glucuronide EtS ethyl sulfate FAA U.S. Federal Aviation Administration FAEE fatty acid ethyl esters FFD fitness for duty FMCSA Federal Motor Carrier Safety Administration vii FMLA Family and Medical Leave Act FRA Federal Railroad Administration FSPHP Federation of State Physician’s Health Programs FTA Federal Transit Administration GC-MS gas chromatography-mass spectrometry GGT gamma-glutamyl transferase GTOL 5-HTOL-glucuronide HRSA Health Resources and Services Administration IC&RC International Certification Reciprocity Consortium LC-MS liquid chromatography-mass spectrometry LC-MS/MS liquid chromatography-tandem mass spectrometry MCV mean corpuscular erythrocyte volume mL milliliter(s) MMPI Minnesota Multiphasic Personality Inventory MRO Medical Review Officer NADAAC National Association for Alcohol and Drug Abuse Counselors NASADAD National Association of State Alcohol and Drug Abuse Directors NBCC National Board for Certified Counselors, Inc. and Affiliates NCADD National Council on Alcoholism and Drug Dependence, Inc. NCC National Certified Counselors ng nanogram NIAAA National Institute on Alcohol Abuse and Alcoholism NIH National Institutes of Health NRC U.S. Nuclear Regulatory Commission PEth phosphatidyl ethanol PHMSA Pipeline and Hazardous Materials Safety Administration PHP physician health program PNNL Pacific Northwest National Laboratory SAE substance abuse expert SAMHSA Substance Abuse and Mental Health Services Administration SAMHSA-HRSA Substance Abuse and Mental Health Services Administration, Health Resources and Services Administration (HRSA) SAP substance abuse professional SME subject matter expert STT screening test technician TAP technical assistance publication USCG U.S. Coast Guard USC United States Code viii Contents Abstract...................................................................................................................................... iii Acknowledgments ....................................................................................................................... v Acronyms and Abbreviations ..................................................................................................... vii 1.0 Introduction ....................................................................................................................... 1.1 1.1 Background ............................................................................................................... 1.1 1.2 Purpose and Research Questions ............................................................................. 1.1 1.3 Methods Overview .................................................................................................... 1.2 1.4 Report Structure ........................................................................................................ 1.3 2.0 Alcohol Use Disorders: Framework and Standards for Diagnosis and Treatment ........... 2.1 2.1 Framework: Levels of Drinking and Alcohol Use Disorder ........................................ 2.1 2.2 AUD Treatment Standards: Guidelines from DHHS Agencies .................................. 2.3 2.2.1 The DHHS and Its Agencies ............................................................................ 2.3 2.2.2 AUD Treatment Guidelines Issued by SAMHSA and NIAAA ........................... 2.3 2.2.3 Summary on AUD Diagnosis and Treatment ................................................... 2.7 2.3 Interviews with Substance Abuse Subject Matter Experts ......................................... 2.7 2.3.1 Expert Interviews: Purpose and Methods ........................................................ 2.7 2.3.2 Description of Substance Abuse Organizations Contacted and Substance Abuse Experts Interviewed .............................................................................. 2.8 2.3.3 Interview Analysis and Results ...................................................................... 2.10 2.3.4 Summary ....................................................................................................... 2.17 3.0 Testing for Alcohol Consumption and Abstinence Compliance ......................................... 3.1 3.1 Alcohol Metabolism and Metabolic Products Used in Testing .................................... 3.1 3.1.1 Overview of Ethanol Metabolism ..................................................................... 3.1 3.1.2 Direct Biomarkers of Ethanol ........................................................................... 3.3 3.1.3 Indirect Biomarkers of Ethanol ......................................................................... 3.4 3.1.4 Alcohol Biomarkers as Abstinence Indicators .................................................. 3.4 3.2 Testing for EtG and Alcohol ....................................................................................... 3.6 3.2.1 Test Matrices ................................................................................................... 3.6 3.2.2 EtG Sample Handling ...................................................................................... 3.7 3.2.3 EtG Test Methods ............................................................................................ 3.7 3.3 Interpreting Positive EtG Test Results ....................................................................... 3.8 3.3.1 Cutoff Levels ................................................................................................... 3.8 3.3.2 Mitigating Factors for Interpreting EtG Test Results ....................................... 3.10 3.4 Summary ................................................................................................................