2005/2006 SWGDRUG ACCOMPLISHMENTS Drug Enforcement Administration Office of Forensic Sciences sponsored by the Office of National Drug Control Policy and the

SWGDRUG Scientific Working Group for the Analysis of Seized Drugs

Mission of SWGDRUG The mission of SWGDRUG is to recommend minimum standards for the forensic examination of seized drugs and to seek their international acceptance.

SWGDRUG Objectives Specifying requirements for practitioners’ knowledge, skills and abilities, Specifying requirements for practitioners’ knowledge, skills and abilities, Promoting professional development, Promoting professional development, Providing a means of information exchange within the forensic science community, Providing a means of information exchange within the forensic science community, Promoting ethical standards of practitioners, Promoting ethical standards of practitioners, Providing minimum standards for examinations and reporting, Providing minimum standards for examinations and reporting, Establishing quality assurance requirements, Establishing quality assurance requirements, Considering relevant international standards, and Considering relevant international standards, and Seeking international acceptance of SWGDRUG recommendations Seeking international acceptance of SWGDRUG recommendations

2005 SWGDRUG Process The SWGDRUG process is an international forensic science community endeavor The SWGDRUG process is an international forensic science community endeavor The role of the core committee is to vote to accept or reject subcommittee recommendations The role of the core committee is to vote to accept or reject subcommittee recommendations In order for a proposal to become an official recommendation, 3/4s of the full core committee must be present. 2/3s of those present must vote in the affirmative (YES) for a proposal to become a recommendation In order for a proposal to become an official recommendation, 3/4s of the full core committee must be present. 2/3s of those present must vote in the affirmative (YES) for a proposal to become a recommendation

2005/2006 SWGDRUG Conference Accomplishments Sampling Seized Drugs Sampling Seized Drugs Botanical Material Addition Botanical Material Addition Supplementary Documents Supplementary Documents Validation of Analytical Methods Validation of Analytical Methods Glossary Glossary Bylaws Bylaws New Website New Website Logo Logo

Sampling for Qualitative Analysis Adopted by the Core Committee in January 2005 Adopted by the Core Committee in January 2005 Goal of the sampling recommendation is to answer relevant questions about a population by only examining a portion Goal of the sampling recommendation is to answer relevant questions about a population by only examining a portion This minimizes the total number of required analytical determinations, while assuring that all relevant legal and scientific requirements are met This minimizes the total number of required analytical determinations, while assuring that all relevant legal and scientific requirements are met

Sampling Strategy Population Determination Sampling Plan StatisticalNon-Statistical Sampling Procedure Sampling for Qualitative Analysis Sampling Scheme

Statistical Based Sampling A Statistically based sampling plan is required if an inference is to be drawn on the entire population A Statistically based sampling plan is required if an inference is to be drawn on the entire population Statistically selected units shall be analyzed to meet SWGDRUG minimum requirements Statistically selected units shall be analyzed to meet SWGDRUG minimum requirements Statistical approaches include: Hypergeometric, Bayesian, ASTM E Statistical approaches include: Hypergeometric, Bayesian, ASTM E

Non-Statistical Sampling A non-statistical approach may suffice to answer questions related to the presence of a drug, or to address statutory enforcement levels A non-statistical approach may suffice to answer questions related to the presence of a drug, or to address statutory enforcement levels A non-statistical approach is appropriate if no inferences are to be made about the entire population A non-statistical approach is appropriate if no inferences are to be made about the entire population Examples of non-statistical approaches include: the UNODC “square root” method and examples from ENFSI 2004 sampling guidelines Examples of non-statistical approaches include: the UNODC “square root” method and examples from ENFSI 2004 sampling guidelines

Population Determination Population Determination shall take into account all typical forms and quantities in which the exhibit may appear Population Determination shall take into account all typical forms and quantities in which the exhibit may appear A population may consist of a single unit or multiple units A population may consist of a single unit or multiple units A multiple unit population shall consist of items which are similar in relevant visual characteristics A multiple unit population shall consist of items which are similar in relevant visual characteristics

Botanical Materials Addition Adopted by the Core Committee in August 2005 Adopted by the Core Committee in August 2005 Allows a properly trained/competent/expert witness in botanical determinations to identify plant material based on documented morphological characteristics Allows a properly trained/competent/expert witness in botanical determinations to identify plant material based on documented morphological characteristics Botanical competence in this context applies to those examiners recognized as professional botanists or those assessed to be competent by such Botanical competence in this context applies to those examiners recognized as professional botanists or those assessed to be competent by such Internationally, this practice is recognized as conforming to existing standards Internationally, this practice is recognized as conforming to existing standards

3.6 An identification of botanical materials may be made utilizing morphological characteristics alone provided sufficient botanical features appropriate for identification are observed. Such examinations shall be made by analysts competent in botanical identifications. Botanical competence in this context applies to those examiners recognized as professional botanists or those assessed to be competent by such. Identifications of chemical components contained in botanicals (mescaline, THC, opiates, psilocin, etc.) shall rely on principles of chemical identification set down in Table 1. Botanical Materials Addition

Supplementary Documents Adopted by the Core Committee in August 2005 Adopted by the Core Committee in August 2005 The supplementary documents are not SWGDRUG recommendations The supplementary documents are not SWGDRUG recommendations Supplementary documents are intended to be a resource for those responsible for implementing SWGDRUG recommendations Supplementary documents are intended to be a resource for those responsible for implementing SWGDRUG recommendations These documents are not inclusive and SWGDRUG recognizes that there are many ways of implementing the recommendations These documents are not inclusive and SWGDRUG recognizes that there are many ways of implementing the recommendations These are living documents and as such, SWGDRUG invites comments. Send your comments to These are living documents and as such, SWGDRUG invites comments. Send your comments to

Properties for Validation Process Supplemental Document SD-2 for Part IVB entitled “Quality Assurance/Validation of Analytical Methods” was finalized for publication in February 2006 Supplemental Document SD-2 for Part IVB entitled “Quality Assurance/Validation of Analytical Methods” was finalized for publication in February 2006 Designed to assist laboratories develop a general validation plan which meet their individual requirements Designed to assist laboratories develop a general validation plan which meet their individual requirements Intended to be used in conjunction with SWGDRUG Recommendations, Part IVB, Section 2 Intended to be used in conjunction with SWGDRUG Recommendations, Part IVB, Section 2 The document is organized into two sections: The document is organized into two sections: Section I provides guidance on the issues to consider when using various analytical techniques Section I provides guidance on the issues to consider when using various analytical techniques Section II is an example of a completed validation plan Section II is an example of a completed validation plan

Properties for Validation Process Section 1 of the document is organized into Categories of Analytical Techniques (IR, MS, HPLC, etc.) from Table 1 – Categories A, B and C Section 1 of the document is organized into Categories of Analytical Techniques (IR, MS, HPLC, etc.) from Table 1 – Categories A, B and C For each instrument or method, specific properties are detailed that could have an effect on how the validation process is formulated and executed For each instrument or method, specific properties are detailed that could have an effect on how the validation process is formulated and executed

Properties for Validation Process Sections titled technique strengths and technique limitations have been added for additional guidance Sections titled technique strengths and technique limitations have been added for additional guidance The techniques selected for an analytical scheme must meet the SWGDRUG minimum recommendations for the forensic identification of seized drugs and must not be correlated The techniques selected for an analytical scheme must meet the SWGDRUG minimum recommendations for the forensic identification of seized drugs and must not be correlated

Properties for Validation Process Section II demonstrates a purpose-defined validation plan for a particular method. Section II demonstrates a purpose-defined validation plan for a particular method. The aim is to show how a complete validation plan may appear The aim is to show how a complete validation plan may appear The example should not be directly applied to methodology used by any laboratory without first considering the specific purpose of a method and its relevant operational environment The example should not be directly applied to methodology used by any laboratory without first considering the specific purpose of a method and its relevant operational environment

Glossary The accepted revised Glossary of terms was adopted by the Core Committee in August 2005 The accepted revised Glossary of terms was adopted by the Core Committee in August 2005 The Glossary was revised to substitute ISO terms and definitions where feasible to promote international acceptance The Glossary was revised to substitute ISO terms and definitions where feasible to promote international acceptance First sought glossaries published by recognized standardizing organizations like ISO, ASTM, IUPAC, UNDCP, and those, where possible, that are primary sources. First sought glossaries published by recognized standardizing organizations like ISO, ASTM, IUPAC, UNDCP, and those, where possible, that are primary sources.

Bylaws Bylaws were adopted by the Core Committee in August 2005 Bylaws were adopted by the Core Committee in August 2005 The Bylaws were drafted to solidify the SWGDRUG process The Bylaws were drafted to solidify the SWGDRUG process

New Website

New website design as of June 2005 New website design as of June 2005 Easier to Navigate Easier to Navigate Promotes better information exchange Promotes better information exchange Future features: Future features: Search Engine Search Engine Questionnaire Form Questionnaire Form Membership Login Membership Login

Logo A logo design concept was established A logo design concept was established Globe to represent international emphasis Globe to represent international emphasis Brown color from original published booklet Brown color from original published booklet

SWGDRUG Information Sources Regional, National and International Associations AAFS, EAFS, ENFSI, IAFS INTERPOL

SWGDRUG Core Committee DEA – Nelson Santos Secretariat – Scott Oulton (non-voting) Secretariat – Scott Oulton (non-voting) FBI - Eileen Waninger FBI - Eileen Waninger ASCLD – Garth Glassburg ASCLD – Garth Glassburg NIST - Susan Ballou NIST - Susan Ballou ASTM and NEAFS- Jack Mario ASTM and NEAFS- Jack Mario Educator – Dr. Chris Tindall Educator – Dr. Chris Tindall

SWGDRUG Core Committee CAC & NWAFS - Jerry Massetti CAC & NWAFS - Jerry Massetti MAFS - Richard Paulas MAFS - Richard Paulas MAAFS - Linda Jackson MAAFS - Linda Jackson SAFS - Dr. Conrad Roberson SAFS - Dr. Conrad Roberson SWAFS - Gary Chasteen SWAFS - Gary Chasteen South Africa - Tshepo Shole South Africa - Tshepo Shole

SWGDRUG Core Committee Canada - Richard Laing Canada - Richard Laing Japan - Dr. Kishi Tohru Japan - Dr. Kishi Tohru United Kingdom - Dr. Sylvia Burns United Kingdom - Dr. Sylvia Burns Australia - Catherine Quinn Australia - Catherine Quinn Germany - Dr. Udo Zerell Germany - Dr. Udo Zerell ENFSI - Dr. Erkki Sippola ENFSI - Dr. Erkki Sippola UNODC - Dr. Iphigenia Naidis UNODC - Dr. Iphigenia Naidis

Continue to Make the SWGDRUG Process a Success All forensic drug analysts must stay involved in the process by contributing comments, criticisms and suggestions. All forensic drug analysts must stay involved in the process by contributing comments, criticisms and suggestions. Stay informed by reading official sources of information. Stay informed by reading official sources of information. If you agree with the process, let us know. If you agree with the process, let us know. If you don’t agree with what you are reading in the publication sources, let us know. If you don’t agree with what you are reading in the publication sources, let us know. Write or any core committee member. Write or any core committee member.