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Source: Teresa Ambrosius, ASB Secretariat
The AAFS Standards Board (ASB) is pleased to announce the publication of ANSI/ASB Standard 036, Standard Practices for Method Validation in Forensic Toxicology, First Edition, 2019.
This standard is produced through ASB’s Toxicology Consensus Body in a consensus process accredited by the American National Standards Institute (ANSI). The standard is based partly on earlier work by the Toxicology Subcommittee of the Organization of Scientific Area Committees (OSAC) for Forensic Science.
This document delineates minimum standards of practice for validating analytical methods used in the field of forensic toxicology that target specific analytes or analyte classes. Specifically, it is intended for the subdisciplines of postmortem forensic toxicology, human performance toxicology (e.g., drug-facilitated crimes and driving-under-the-influence of alcohol or drugs), non-regulated employment drug testing, court-ordered toxicology (e.g., probation and parole, drug courts, child services), and general forensic toxicology (non-lethal poisonings or intoxications). This document is not intended to address method validation in the discipline of breath alcohol testing. The fundamental reason for performing method validation is to ensure confidence and reliability in forensic toxicological test results by demonstrating the method is fit for its intended use.
ASB documents are available for download in the Published Documents portion of the ASB website.
The ASB is an ANSI-accredited Standards Developing Organization with the purpose of providing accessible, high-quality, science-based consensus forensic standards. The ASB is a wholly owned subsidiary of the American Academy of Forensic Sciences (AAFS), established in 2015, and accredited by the ANSI in 2016. The ASB is partially funded by a grant through the Laura and John Arnold Foundation.
The ASB consists of Consensus Bodies (CB), which are open to all materially interested and affected individuals, companies, and organizations; a Board of Directors; and Staff.
ANSI facilitates the development of American National Standards (ANS) by accrediting the procedures of Standards Developing Organizations (SDOs). Accreditation by ANSI signifies that the procedures used by the standards body in connection with the development of American National Standards meet the Institute’s essential requirements for openness, balance, consensus, and due process.
The National Technology Transfer and Advancement Act (NTTAA) of 1995 (Public Law 104-113) and its implementation directive, Office of Management and Budget Circular A-119, direct federal agencies to utilize voluntary consensus standards where feasible and to participate as appropriate in voluntary consensus standards development activities. Standards developed in accordance with ANSI’s accreditation requirements satisfy obligations incumbent on federal agencies to use or adopt voluntary consensus standards.
In order to maintain ANSI accreditation, standards developers are required to consistently adhere to a set of requirements or procedures that govern the consensus development process. These requirements are set forth in a document known as the ANSI Essential Requirements: Due process requirements for American National Standards (www.ansi.org/essentialrequirements).
Due process is the key to ensuring that ANSs are developed in an environment that is equitable, accessible, and responsive to the requirements of various stakeholders. The open and fair ANS process ensures that all interested and affected parties have an opportunity to participate in a standard’s development. It also serves and protects the public interest since standards developers accredited by ANSI must meet the Institute’s essential requirements and other due process safeguards.