benefits, risks and dangers associated with use and Briefing: abuse of illicit and recreational drugs, medications and alcohol. Forensic toxicology is governed through What is Forensic a professional certifying and accrediting board – The American Board of Forensic Toxicology (ABFT) – Toxicology? and promotes professional development and education through major professional organiza‐
tions, the Society of Forensic Toxicologists (SOFT), Prepared by: the American Academy of Forensic Sciences (AAFS), and international organizations such as The The Forensic Toxicology Council, July 2010 International Association of Forensic Toxicologists (TIAFT). What is Forensic Toxicology? Death Investigation Toxicology Toxicology is the study of the adverse effects of (Postmortem Toxicology): drugs and chemicals on Forensic toxicologists work biological systems. Forensic with pathologists, medical toxicology deals with the The Forensic Toxicology Council (FTC) examiners and coroners in application of toxicology to was formed in 2009 to represent the helping to establish the cases and issues where interests of the major professional role of alcohol, drugs and those adverse effects have organizations in forensic toxicology in poisons in the causation of administrative or medico‐ the United States. The FTC is comprised death. The toxicologist legal consequences, and of the senior officers and identifies and quantifies where the results are likely representatives of the American Board the presence of drugs and to be used in court. Foren‐ of Forensic Toxicology (ABFT)*, the chemicals in blood and sic toxicology is a thorough‐ Toxicology Section of the American tissue samples. This is done ly modern science, based on Academy of Forensic Sciences (AAFS)*, using state of the art published and widely chemical and biomedical accepted scientific methods and the Society of Forensic instrumentation capable of and practices, for both Toxicologists (SOFT)*. The FTC was detecting small amounts of analysis of drugs in formed specifically to provide toxic materials, positively biological materials, and information to government and policy identifying them, and ac‐ interpretation of those makers regarding this field, and to curately measuring how results. Many of the promote the advancement and much is present. Accuracy, methods it employs have development of forensic toxicology. validity and reliability are been derived from innova‐ essential, as this informa‐ tions in clinical medicine *The FTC does not speak for, or advocate policy on behalf of ABFT, AAFS, or SOFT. tion is used in the deter‐ and academic laboratories mination of cause and throughout the world. manner of death. Those Thousands of articles related to forensic toxicology determinations are the prerogative of the medical methods, instrumentation and interpretation are examiner or coroner; how‐ever, the toxicologist is a published in hundreds of peer reviewed journals key member of the team of experts that assist in that every year, and increase our understanding of the determination, consulting on pharmacology, drug Page 1
kinetics and interactions, metabolism, adverse and provides interpretation of the result with respect to idiosyncratic reactions, drug tolerance, postmortem whether the dose represents typical therapeutic use, artifacts, drug stability, and other factors. The recreational use, or potential abuse, and can provide pathologist considers this information in the context opinions about the likely effects of these patterns of of the investigative and medical history of the case, use. This can include performance enhancement and the findings of disease or other medical which occurs following the use of stimulants, and conditions at autopsy. Accurately establishing the impairment from recreational or prescription appropriate cause and manner of death has serious medication use and misuse. Forensic toxicologists implications for public health and public safety, and review and testify in cases of impaired driving forensically reliable toxicology is an essential involving alcohol and drugs, and address diverse component of that process. Death Investigation issues such as transportation safety, drug facilitated toxicology is performed by both public and private crimes, competency, intoxication and diminished laboratories and many private forensic laboratories capacity. Forensic toxicologists frequently testify in provide specialized expertise and services not court to both their findings and to their available in government laboratories. interpretation. This type of testing may occur in public crime laboratories, but also may be a function Human Performance Toxicology: of a health department in some states. Many blood Human Performance Tox‐ alcohol and drug testing icology deals with the cases are performed in The four disciplines of Forensic Toxicology: effects of alcohol and accredited private or drugs on human perform‐ Death Investigation Toxicology academic forensic toxic‐ ance and behavior, and (Postmortem Toxicology) ology laboratories that the medico‐legal conse‐ voluntarily observe the Human Performance Toxicology quences of drug and same standards in place alcohol use. This may Doping Control in the public sector. include investigations of Forensic Workplace Drug Testing Additionally, most states impaired driving, vehic‐ have thousands of al‐ ular assault and homicide, cohol breath testing operators which function under drug facilitated crimes including sexual assault, and certification from a wide variety of state systems. aircraft, motor vehicle and maritime collision Alcohol breath calibration laboratories are also investigations. Forensic toxicologists perform beginning to be accredited under ASCLD‐LAB and ISO analysis of drugs and alcohol in biological samples, 17025. Alcohol breath testing produces evidence in typically blood and urine, but increasingly in other DUI and impairment cases but is also integral in matrices such as oral fluid, and hair, for the purposes workplace drug testing. of determining the timing, extent, and impairment resulting from different patterns of drug and alcohol Doping Control: use. The toxicologist uses state‐of‐the‐art analytical methods, such as are found in many research and Governing bodies of most competitive and hospital laboratories to isolate drugs from complex intramural sports have derived rules regarding biological samples, prepare them for analysis performance enhancing drug use to protect the through extraction and purification, then determine health and welfare of the amateur and professional the identity and amount of drug present. Following athletes, to maintain a fair and even competitive the analytical phase, the forensic toxicologist standard, and avoid wagering fraud. This applies to Page 2
both human and animal sports. International groups scientists employ highly uniform and well‐defined such as the International Olympic Committee (IOC), techniques and methods to minimize the risk of the World Anti‐Doping Agency (WADA), and the errors, and ensure that employees are treated fairly International Federation of Horseracing Authorities and that testing is done to the highest forensic (IFHA) work to update and maintain these lists as standards. The majority of workplace drug testing is patterns of drug use change. Enforcing these rules not covered directly by accreditation programs requires periodic off‐season random and event‐ however. These unregulated programs can perform focused drug testing for performance enhancing tests using other matrices such as oral fluid, sweat drugs, and other medications that appear on the and hair. organizations prohibited substances lists. Forensic toxicologists in this field use many of the same high A related subset of workplace testing is for parole performance analytical methods to detect current and probation both at the state and federal levels. and historical use of banned substances, including This testing is often conducted with methods similar stimulants, anabolic steroids, and diuretics. This type to workplace samples but is applicable to the of testing occurs in commercial and public accredited criminal system in the management of parolees. laboratories around the world, though there is also Outside of the military, almost all of this testing testing of high‐school, college and other athletes occurs in commercial laboratories. that occurs in private laboratories. Promoting Scientific Excellence Forensic Workplace Drug Testing: and Professional Standards in Use of drugs by people in the workplace has Forensic Toxicology significant safety and economic consequences. Consequently, in the United States, workers in safety In 2009, the FTC established a scientific working sensitive positions are prohibited from using rec‐ group in forensic toxicology (SWGTOX) to organize reational drugs or taking certain medications without efforts to advance and standardize the practice of a prescription. Enforcing these standards requires forensic toxicology in US laboratories. The activities pre‐employment, random, and for‐cause drug of SWGTOX are discussed below. The FTC received testing, such as following an accident or a trans‐ funding support from the National Institute of justice portation collision. Members of the US military, (NIJ) to launch SWGTOX which had its inaugural employees working for the Federal Government, or workgroup meetings in February 2009. their contractors are also required to comply with SOFT and the AAFS Toxicology Section developed a these standards set forth in the Drug‐Free Workplace guidance document in the 1990’s to identify good Act adopted by Congress in 1988. Forensic toxic‐ practices in forensic toxicology related to quality ologists perform testing of urine samples in these control and quality assurance, method selection and laboratories regulated and inspected on behalf of operation, instrument and equipment maintenance, the Federal Government in a program managed by staff qualifications and training, documentation of the Substance Abuse and Mental Health Services results, and laboratory management and safety. Administration (SAMHSA). Testing for five major These guidelines became the basis for the develop‐ classes of abused drugs and their metabolites, these
The SOFT/AAFS Laboratory Guidelines are available at:
http://www.soft‐tox.org/?pn=publications&sp=Laboratory_Guidelines
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ment of a laboratory accreditation program imple‐ and regulations already exist (e.g., Federal Drug‐Free mented by ABFT in 1996. Currently 26 forensic Workplace Program and the World Anti‐Doping toxicology laboratories are accredited. Agency).
The National Laboratory Certification Program These committees conduct business through estab‐ (NLCP) currently accredits 38 regulated workplace lished subcommittees and task groups to focus on laboratories. These laboratories are inspected and specific aspects of the SWGTOX mission. The evaluated under federal guidelines. Again these objectives of the SWGTOX are to establish minimum guidelines address good practices for forensic standards for the practice of forensic toxicology in toxicology and quality control and assurance. the following areas 1) Standards, practice, protocols including quality assurance and quality control, 2) The SOFT/AAFS Laboratory Guidelines committee Educational requirements, 3) Accreditation has continued to review and update the guidelines, (laboratory compliance with standards of practice), and the most recent version was updated in 2006. and 4) Certification (individual compliance with ABFT continues to work with the SOFT/AAFS com‐ educational and experience standard to practice mittee in its revisions to the ABFT inspection forensic toxicology). SWGTOX will also establish a checklist to account for developments in technology, uniform Code of Ethics for forensic toxicologists, instrumentation and standards of practice. identify areas of research and development in the In 2009, ABFT began the process of aligning its lab‐ field of forensic toxicology, and promote public oratory accreditation program with ISO/IEC stand‐ awareness of the field of forensic toxicology through ards. Both ISO 17025 (Testing and Calibration outreach. Laboratories), and ISO 15189 (Clinical Laboratories) were evaluated, and ABFT is pursuing ISO 15189 as a What professional groups template for this ISO accreditation. represent Forensic Toxicology?
SWGTOX – The American Academy of Forensic Sciences www.SWGTOX.org (AAFS) – Toxicology Section – SWGTOX was constit‐ www.aafs.org uted by the FTC in The three committees of SWG‐Tox: AAFS is a multi‐ October 2009, at the disciplinary organization annual SOFT meeting Standards, Practice, Protocols and Accreditation representing forensic in Oklahoma City. The Education, Ethics, Outreach and Certification sciences in the United States. AAFS has over mission of the Research, Development, Testing and Evaluation SWGTOX is to investi‐ 6000 members who are gate, analyze, develop engaged in the practice and disseminate consensus in standards of practice of forensic science or in training in this field. AAFS for forensic toxicology. The scope of SWGTOX promotes professional development, research, activities includes post‐mortem and human perfor‐ sharing of information, professional networking, and mance toxicology. While the standards developed by recognition of leadership and service in the forensic SWGTOX are considered good standard practice in all science community. AAFS publishes a peer‐reviewed forensic toxicology disciplines, the scope of SWGTOX Journal – the Journal of Forensic Sciences. The AAFS activities does not necessarily include those Toxicology Section provides training and education specialized areas where mandated, codified rules activities for its members, governs committees Page 4
dedicated to the advancement of forensic toxicology leading developments in the field. SOFT also sub‐disciplines and promotes the advancement of maintains committees charged with the develop‐ knowledge in the field. ment of standards for analytical toxicology laborat‐ ories, which collaborates with ABFT and AAFS. SOFT The American Board of Forensic Toxicology and AAFS have jointly prepared a document on (ABFT) – Laboratory Guidelines designed to promote consist‐ www.abft.org ent minimum standards of practice. These guidelines Established in became the basis for the ABFT Laboratory Accredita‐ 1975 as a pro‐ tion checklist. fessional certi‐ fication Board Forensic Toxicology Council (FTC) – for the disci‐ The FTC was formed in 2009 to coordinate the pline of forensic efforts of the leadership of the three organizations toxicology, ABFT certifies appropriately qualifyied described above, to ensure consistency in plans for individuals as professional toxicologists. The criteria professional development of the field, a unified voice for certification are education, experience, successful for forensic toxicology on matters related to legisla‐ completion of an examination, and documented tive or regulatory action governing forensic toxic‐ continuing professional education. Certification is ology laboratories, and to manage projects that awarded at the Diplomate (PhD) level and Forensic require the joint efforts of the three organizations Toxicology Specialist (non‐PhD) level. Currently there specifically the development of a SWGTOX. The FTC are 220 Board certified forensic toxicologists in the membership is comprised of the ranking officers of United States and internationally. ABFT maintains SOFT, ABFT and the AAFS Toxicology section along and enforces a code of ethics for its certificants. with the representatives of SOFT and ABFT to the ABFT also offers accreditation to forensic toxicology Consortium of Forensic Science Organizations laboratories, based on compliance with a (CFSO). comprehensive checklist, participation in proficiency testing programs, and on‐site inspections and re‐ Other – inspections. ABFT is accredited by the Forensic Various regional forensic science and forensic toxic‐ Specialties Accreditation Board (FSAB). ology groups exist around the United States, and have local meetings and trainings. The membership Society of Forensic Toxicologists (SOFT) – of these regional groups overlaps significantly with www.soft‐tox.org the above organizations. SOFT is a professional membership organization for forensic toxicology professionals with more than 900 members. It holds an annual meeting for the presentation of research and case reports, new anal‐ ytical methods and data analysis. Its abstracts are peer reviewed. SOFT publishes annually a special issue of the Journal of Analytical Toxicology featuring Page 5
Forensic Toxicology Statistics Volume of samples (Monthly workload) It is very difficult to get accurate numbers that SOFT recently surveyed the toxicology community to reflect the total workload in toxicology due to the better understand the nature of the profession. variability in how cases and samples are counted. These figures represent preliminary results of these However, approximately 6.5 million workplace sam‐ efforts. ples are tested under federal regulation and an additional estimated 50 million non‐regulated work‐ Self reported type of laboratory place samples are tested annually. Of the lab‐ Laboratories were asked how they would character‐ oratories responding, there is a broad distribution of ize their laboratory. It should be noted that many workloads from only 1 case per month to the highest laboratories handle multiple types of work. This is as reporting 260,000 samples per month. a percentage of laboratories not as a percentage of the work.
Forensic drug testing 8% 28% 28% Postmortem toxicology
Human performance 35% Independent consultant
Laboratory Accreditation
Less than 1% of responses indicated doping control. Only a few states (New York, Texas and Oklahoma) and Federal programs require laboratory accredita‐ Funding or business model of laboratory tion. Not all forensic toxicology laboratories are Laboratories were asked how they are funded. accredited; however on a largely voluntary basis Again, laboratories may have multiple sources of accreditation is well established in the field under a funding. This also indicates 41% of toxicology number of programs. Many laboratories participate laboratories responding are other than publicly in more than one program. funded. Percentage of laboratories reporting participation in accreditation programs County Funded 4% 2% 3% American Board of Forensic Toxicology (ABFT) 24% Federally funded ISO 17025 15% 10% 18% State funded ISO 15189 1% 7% ISO 17011 0% City or Municipality funded 22% National Laboratory Certification Program (NLCP) 20% 27% Commercially funded ASCLD‐LAB (legacy) 18% 5% CLIA 21% Hospital not for profit College of American Pathologists (CAP) 30% Univerity not for profit State programs (including alcohol accreditations) 22%
Independent not for profit Department of Defense (military drug screening) 3% No accreditation 12% Other
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Contact Information Philip Kemp, PhD, DABFT AAFS Toxicology Section Secretary ARLOK Laboratories Additional information can be obtained from 840 Research Parkway, Suite. 546 members of the FTC, SWGTOX, and their related Oklahoma City, OK 73104 organizations by contacting: (405) 271‐1144 [email protected] Officers: Sarah Kerrigan, PhD Barry K Logan, PhD, DABFT (Chair) SOFT Vice President AAFS Vice President Sam Houston Regional Crime Laboratory NMS Labs 8301 New Trails Drive, Suite 125 3701 Welsh Road The Woodlands, TX 77381 Willow Grove, PA 18901 (936) 294‐2503 (267) 615‐3516 [email protected] [email protected] Marina Stajic, PhD, DABFT Bruce A Goldberger, PhD, DABFT (Secretary) ABFT President ABFT Vice President Office of Chief Medical Examiner Dept of Pathology, Immunology & Laboratory Medicine 520 First Avenue University of Florida College of Medicine New York, NY 10016 4800 S.W. 35th Drive (212) 447‐2637 Gainesville, FL 32608 [email protected] (352) 265‐0680 x72001 [email protected] Peter R Stout PhD, DABFT SOFT representative to CFSO Members: RTI International Yale H Caplan PhD, DABFT 3040 Cornwallis Road ABFT representative to CFSO PO Box 12194 National Scientific Services Research Triangle Park, NC 27709 3411 Phillips Drive (919) 316 3450 Baltimore, MD 21208 [email protected] (410) 486‐7486 [email protected] SWGTOX Co‐Chairs: Kenneth E Ferslew PhD, DABFT Daniel S Isenschmid, PhD, DABFT AAFS Toxicology Section Chair Wayne County Medical Examiner’s Office East Tennessee State University 1300 East Warren Avenue Toxicology Section, Box 70422 Detroit, MI 48207 Johnson City, TN 37614 (313) 833‐2552 (423) 439‐6424 [email protected] [email protected] Robert A Middleberg PhD, DABFT Bradford R Helper, PhD, DABFT NMS Labs SOFT President 3701 Welsh Road Wayne County Medical Examiner’s Office Willow Grove, PA 18901 1300 East Warren Avenue (267) 615‐3516 Detroit, MI 48207 [email protected] (313) 833‐2552 Bruce A Goldberger, PhD, DABFT [email protected]
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