Priority Action Report

Toxicology Subcommittee

Chemistry / Instrumental Analysis Scientific Area Committee

Marc A. LeBeau, PhD, F-ABFT

February 23, 2016
Discipline Description

The OSAC Subcommittee on

Toxicology will focus on standards

and guidelines related to the

analysis of biological samples for

alcohol, drugs, or poisons, and the

interpretation of these results.

2
Subcommittee Leadership

Position Name Organization Term Email

Chair Marc A LeBeau, 

PhD FBI 2 marc.lebeau@ic.fbi.gov

Vice Chair Melissa Kennedy, 

MS ASCLD-LAB 3 mkennedy@ascld-lab.org

Executive 

Secretary Fiona Couper, PhD WA State Patrol 2 fiona.couper@wsp.wa.gov

3
Subcommittee Members

# Name Organization Term Email

1 Daniel Anderson, MS CO Bureau of 

Investigation 3 daniel.anderson@state.co.us

2 Connie Borror, PhD AZ State University 3 cborror@asu.edu

3 Sabra Botch-Jones, MS Boston University 4 sabraj@bu.edu

4 Nichole Bynum, MS RTI International 2 nbynum@rti.org

5 Kenneth Ferslew, PhD East TN State University 4 ferslew@etsu.edu

6 Marilyn Huestis, PhD National Institute on

Drug Abuse (Retired) 4 marilyn.huestis@gmail.com

7 Robert Johnson, PhD Tarrant County ME’s 

Office 3 rdjohnson@tarrantcounty.com

8 Matthew Juhascik, PhD Montgomery County

Coroner’s Office 3 juhascikm@mcohio.org

9 Philip Kemp , PhD FAA 3 philip.kemp@faa.gov
Subcommittee Members

# Name Organization Term Email

10 Jennifer Limoges, MSFS NY State Police 2 jennifer.limoges@troopers.ny.gov

11 Robert Middleberg, PhD NMS Labs 2 robert.middleberg@nmslabs.com

12 Madeline Montgomery FBI 4 madeline.montgomery@ic.fbi.gov

13 Christine Moore, PhD Immunalysis Corporation 2 cmoore@immunalysis.com

14 Sumandeep Rana, PhD Redwood Toxicology 

Laboratories 3 srana@redwoodtoxicology.com

15 Robert Sears, MS SC Law Enforcement 

Division 2 robsears@sled.sc.gov

16 Ruth Winecker, PhD NC Office of Chief ME 4 ruth.winecker@dhhs.nc.gov

17 Dustin Tate Yeatman, MS Palm Beach County 

Sheriff 4 yeatmand@pbso.org
6

January 2016 OSAC Toxicology Subcommittee Meeting

Leesburg, Virginia
Summary of Standards/Guidelines 

Priority Actions

Topic Working Title of Document

1 Standard Practices for Method Validation in Forensic Toxicology

2

Standard Practices for Measurement Traceability in Forensic 

Toxicology

3

Standard Practices for Method Validation in Forensic Toxicology 

– Breath Alcohol Measuring Instrument Calibration

4 Standard Practices for Quality Control in Forensic Toxicology

5

Guidelines for Opinions and Testimony in Forensic Toxicology

7
OSAC Review/Approval of Standards of Practice 

Priority Action Project and 

Task Group Established

Task Group Develops First 

Draft of Document

Draft Presented to 

Subcommittee for 

Comments 

(30 days)

Revisions by Task Group to 

Form Draft Final 

Document

Draft Final Document 

Approved by Task Group

Draft Final Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Prepared

OSAC Packet Approved by 

Subcommittee 

(15 days)

OSAC Packet Provided to 

SAC and RCs for 

Comments

(30 days)

Revisions by Task Group 

(as appropriate)

Final Document Approved 

by Task Group 

Final Document Provided 

to Subcommittee for 

Discussion

Final Document Approved 

by Subcommittee 

(15 days)

Approval by SAC to Send 

Final Document to SDO

(15 days)

Final Document Sent to 

SDO

SDO-Revised Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Revised for 

SDO Document 

SDO Packet Approved by 

Subcommittee to Place on 

Registry 

(30 days)

SDO Packet Approved by 

SAC to Issue Notice of 

Intent to Place on Registry

(30 days)

Notice of Intent to Place 

on Registry for Public 

Comments (30 days)

Public Comments 

Reviewed and Addressed

SDO Packet Approved by 

SAC to Place on Registry

SDO Packet Approved by 

FSSB to Place on Registry

(30 days)

SDO-Revised Document 

Placed on Registry
Topic 1: Method Validation

Document Title: Standard Practices for Method Validation in 

Forensic Toxicology Laboratories

Scope: Minimum standards of practice for validating 

analytical methods in forensic toxicology.

Objective/rationale: Provide objective evidence that a method is 

capable of successfully performing at the 

level of its intended use and identify 

limitations under normal operating 

conditions.

Issues/Concerns: Revision of SWGTOX Validation Standard

Task Group Chair Name: Marc LeBeau

Task Group Chair Contact Information: 

marc.lebeau@ic.fbi.gov

Date of Last Task Group Meeting: October 2015

9
Key Components of Standard:

• Delineates when to validate and revalidate analytical methods

• Requires formation of validation plan

• Defines required validation parameters based on method’s scope

• Provides specific requirements for conducting validation 

experiments

• Explains documentation requirements of validation records

• Appendices provide examples, as well as recommendations on 

how to streamline method validation experiments

10

Topic 1: Method Validation
11

Priority Action Project and 

Task Group Established

Task Group Develops First 

Draft of Document

Draft Presented to 

Subcommittee for 

Comments 

(30 days)

Revisions by Task Group to 

Form Draft Final 

Document

Draft Final Document 

Approved by Task Group

Draft Final Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Prepared

OSAC Packet Approved by 

Subcommittee 

(15 days)

OSAC Packet Provided to 

SAC and RCs for 

Comments

(30 days)

Revisions by Task Group 

(as appropriate)

Final Document Approved 

by Task Group 

Final Document Provided 

to Subcommittee for 

Discussion

Final Document Approved 

by Subcommittee 

(15 days)

Approval by SAC to Send 

Final Document to SDO

(15 days)

Final Document Sent to 

SDO

SDO-Revised Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Revised for 

SDO Document 

SDO Packet Approved by 

Subcommittee to Place on 

Registry 

(30 days)

SDO Packet Approved by 

SAC to Issue Notice of 

Intent to Place on Registry

(30 days)

Notice of Intent to Place 

on Registry for Public 

Comments (30 days)

Public Comments 

Reviewed and Addressed

SDO Packet Approved by 

SAC to Place on Registry

SDO Packet Approved by 

FSSB to Place on Registry

(30 days)

SDO-Revised Document 

Placed on Registry

Topic 1: Method Validation
Topic 2: Measurement Traceability

Document Title: Standard Practices for Measurement 

Traceability in Forensic Toxicology

Scope: Minimum standards of practice for establishing 

measurement traceability in forensic toxicology 

testing and calibration methods.

Objective/rationale: Provide objective evidence that 

measurement traceability has been 

established in forensic toxicology methods.

Issues/Concerns: New concept for laboratories accredited by 

bodies that do not follow ISO standards

Task Group Chair Name: Dustin Yeatman

Task Group Chair Contact Information: 

yeatmand@pbso.org

Date of Last Task Group Meeting: January 2016

12
Key Components of Standard:

• Explains what may be considered a measurement

• Provides NIST’s essential elements of measurement traceability

• Demonstrates how measurement traceability may be established 

through the calibration of equipment and use of certified 

reference materials

• Describes measurement traceability requirements based on 

method scope

• Defines laboratory equipment that must be calibrated to establish 

measurement traceability

13

Topic 2: Measurement Traceability
14

Priority Action Project and 

Task Group Established

Task Group Develops First 

Draft of Document

Draft Presented to 

Subcommittee for 

Comments 

(30 days)

Revisions by Task Group to 

Form Draft Final 

Document

Draft Final Document 

Approved by Task Group

Draft Final Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Prepared

OSAC Packet Approved by 

Subcommittee 

(15 days)

OSAC Packet Provided to 

SAC and RCs for 

Comments

(30 days)

Revisions by Task Group 

(as appropriate)

Final Document Approved 

by Task Group 

Final Document Provided 

to Subcommittee for 

Discussion

Final Document Approved 

by Subcommittee 

(15 days)

Approval by SAC to Send 

Final Document to SDO

(15 days)

Final Document Sent to 

SDO

SDO-Revised Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Revised for 

SDO Document 

SDO Packet Approved by 

Subcommittee to Place on 

Registry 

(30 days)

SDO Packet Approved by 

SAC to Issue Notice of 

Intent to Place on Registry

(30 days)

Notice of Intent to Place 

on Registry for Public 

Comments (30 days)

Public Comments 

Reviewed and Addressed

SDO Packet Approved by 

SAC to Place on Registry

SDO Packet Approved by 

FSSB to Place on Registry

(30 days)

SDO-Revised Document 

Placed on Registry

Topic 2: Measurement Traceability
Topic 3: Breath Alcohol Calibration

Document Title: Standard Practices for Method Validation in 

Forensic Toxicology – Breath Alcohol 

Measuring Instrument Calibration

Scope: Minimum standards for validating calibration methods in 

forensic toxicology laboratories performing evidentiary 

Breath Alcohol Measuring Instrument calibration. 

Objective/rationale: Provide objective evidence that a method is 

capable of successfully performing at the 

level of its intended use and identify 

limitations under normal operating conditions.

Issues/Concerns: None

Task Group Chair Name: Melissa Kennedy

Task Group Chair Contact Information: 

melissa.kennedy@dfs.virginia.gov

Date of Last Task Group Meeting: January 2016

15
Key Components of Standard: 

• Delineates when to validate and revalidate analytical methods

• Requires formation of validation plan

• Defines required validation parameters based on method’s scope

• Provides specific requirements for conducting validation experiments

• Explains documentation requirements of validation records

• Appendices provide examples, as well as recommendations on how to 

streamline method validation experiments

16

Topic 3: Breath Alcohol Calibration
17

Priority Action Project and 

Task Group Established

Task Group Develops First 

Draft of Document

Draft Presented to 

Subcommittee for 

Comments 

(30 days)

Revisions by Task Group to 

Form Draft Final 

Document

Draft Final Document 

Approved by Task Group

Draft Final Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Prepared

OSAC Packet Approved by 

Subcommittee 

(15 days)

OSAC Packet Provided to 

SAC and RCs for 

Comments

(30 days)

Revisions by Task Group 

(as appropriate)

Final Document Approved 

by Task Group 

Final Document Provided 

to Subcommittee for 

Discussion

Final Document Approved 

by Subcommittee 

(15 days)

Approval by SAC to Send 

Final Document to SDO

(15 days)

Final Document Sent to 

SDO

SDO-Revised Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Revised for 

SDO Document 

SDO Packet Approved by 

Subcommittee to Place on 

Registry 

(30 days)

SDO Packet Approved by 

SAC to Issue Notice of 

Intent to Place on Registry

(30 days)

Notice of Intent to Place 

on Registry for Public 

Comments (30 days)

Public Comments 

Reviewed and Addressed

SDO Packet Approved by 

SAC to Place on Registry

SDO Packet Approved by 

FSSB to Place on Registry

(30 days)

SDO-Revised Document 

Placed on Registry

Topic 3: Breath Alcohol Calibration
Topic 4: Quality Control

Document Title: Standard Practices for Quality Control in 

Forensic Toxicology

Scope: Minimum standards of practice for quality control in 

forensic toxicology laboratories

Objective/rationale: Provide objective evidence that 

day-to-day use of a method continues to 

perform as validated 

Issues/Concerns: None

Task Group Chair Name: Ruth Winecker

Task Group Chair Contact Information: 

ruth.winecker@dhhs.nc.gov

Date of Last Task Group Meeting: January 2016

18
Key Components of Standard: 

• Defines requirements of quality control programs within forensic 

toxicology laboratories

• Explains use and verification of QC materials

• Provides direction on preparation, storage, expiration, and 

documentation of calibrators and controls

• Instructs on calibration and control of chromatographic, 

immunoassay, spectrophotometric, and other assays

• Explains elements of quality control reviews, as well as long-term 

monitoring of QC data

19

Topic 4: Quality Control
20

Priority Action Project and 

Task Group Established

Task Group Develops First 

Draft of Document

Draft Presented to 

Subcommittee for 

Comments 

(30 days)

Revisions by Task Group to 

Form Draft Final 

Document

Draft Final Document 

Approved by Task Group

Draft Final Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Prepared

OSAC Packet Approved by 

Subcommittee 

(15 days)

OSAC Packet Provided to 

SAC and RCs for 

Comments

(30 days)

Revisions by Task Group 

(as appropriate)

Final Document Approved 

by Task Group 

Final Document Provided 

to Subcommittee for 

Discussion

Final Document Approved 

by Subcommittee 

(15 days)

Approval by SAC to Send 

Final Document to SDO

(15 days)

Final Document Sent to 

SDO

SDO-Revised Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Revised for 

SDO Document 

SDO Packet Approved by 

Subcommittee to Place on 

Registry 

(30 days)

SDO Packet Approved by 

SAC to Issue Notice of 

Intent to Place on Registry

(30 days)

Notice of Intent to Place 

on Registry for Public 

Comments (30 days)

Public Comments 

Reviewed and Addressed

SDO Packet Approved by 

SAC to Place on Registry

SDO Packet Approved by 

FSSB to Place on Registry

(30 days)

SDO-Revised Document 

Placed on Registry

Topic 4: Quality Control
Topic 5: Opinions and Testimony

Document Title: Guidelines for Opinions and Testimony in 

Forensic Toxicology

Scope: Delineates guidelines for practices in forensic 

toxicology opinion reports and testimony.

Objective/rationale: Recommends practices to be used in 

expert opinions, including those defined as 

“appropriate” and “inappropriate”.

Issues/Concerns: None

Task Group Chair Name: Madeline Montgomery

Task Group Chair Contact Information: 

madeline.montgomery@ic.fbi.gov

Date of Last Task Group Meeting: January 2016

21
Key Components of Guideline:

• Explains difference between basic analytical toxicology reports 

and opinion reports

• Provides direction on elements of expert opinions

• Defines appropriate opinions and testimonies that are 

scientifically supported

• Describes opinions and testimony that are inappropriate for a 

toxicologist to address

22

Topic 5: Opinions and Testimony
23

Priority Action Project and 

Task Group Established

Task Group Develops First 

Draft of Document

Draft Presented to 

Subcommittee for 

Comments 

(30 days)

Revisions by Task Group to 

Form Draft Final 

Document

Draft Final Document 

Approved by Task Group

Draft Final Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Prepared

OSAC Packet Approved by 

Subcommittee 

(15 days)

OSAC Packet Provided to 

SAC and RCs for 

Comments

(30 days)

Revisions by Task Group 

(as appropriate)

Final Document Approved 

by Task Group 

Final Document Provided 

to Subcommittee for 

Discussion

Final Document Approved 

by Subcommittee 

(15 days)

Approval by SAC to Send 

Final Document to SDO

(15 days)

Final Document Sent to 

SDO

SDO-Revised Document 

Provided to Subcommittee 

for Discussion

OSAC Packet Revised for 

SDO Document 

SDO Packet Approved by 

Subcommittee to Place on 

Registry 

(30 days)

SDO Packet Approved by 

SAC to Issue Notice of 

Intent to Place on Registry

(30 days)

Notice of Intent to Place 

on Registry for Public 

Comments (30 days)

Public Comments 

Reviewed and Addressed

SDO Packet Approved by 

SAC to Place on Registry

SDO Packet Approved by 

FSSB to Place on Registry

(30 days)

SDO-Revised Document 

Placed on Registry

Topic 5: Opinions and Testimony
Other Ongoing Topics

Document Evaluation Task Group

• Evaluation of existing standards and guides

• Identification of gaps in the catalog of standards and guides

• Facilitation of document reviews and approvals using canvass or SDO 

processes

Task Group Chair Name: Fiona Couper

Task Group Chair Contact Information: 

fiona.couper@wsp.wa.gov

Date of Last Task Group Meeting: January 2016

24

Terminology Task Group

• Establish glossary of terms in the field of forensic toxicology to be used 

within documents developed by the subcommittee

Task Group Chair Name: Kenneth Ferslew

Task Group Chair Contact Information: 

ferslew@etsu.edu

Date of Last Task Group Meeting: January 2016
Additional Topics of Interest

• Standard for Mass Spectrometry Data Evaluation in Forensic 

Toxicology*

• Standard for Forensic Toxicology Reports*

• Standard for Identification Criteria for Forensic Toxicology*

• Standard for Content of Forensic Toxicology Standard Operating 

Procedures

• Standard for Estimating Measurement Uncertainty in Forensic 

Toxicology

• Guideline for Specimen Collection and Storage in Forensic Toxicology

• Standard for Quality Control Practices for Breath Alcohol Testing

• Standard for Proficiency Testing in Forensic Toxicology

• Standard for Minimum Testing Requirements in Forensic Toxicology

25

* Indicates new Task Group initiated
Research Gaps Identified

• Emerging Drugs of Abuse and Therapeutic Agents

• Develop analytical methods, evaluate existing and novel 

sample preparation techniques, epidemiological studies, 

metabolite identification, post-mortem distribution, 

pharmacodynamics/pharmacokinetic studies

• Herbal and Dietary Supplements and Plant-based 

Toxins

• Develop analytical methods, improve understanding of toxicity

26
Research Gaps Identified

• Human Factors Impact on Forensic Toxicology

• Determine whether cognitive and contextual biases impact how 

cases are analyzed and conclusions made, impacts of 

motivational issues, fitness for duty (e.g. fatigue, visual acuity), 

scientific culture, group dynamics and error management

• Postmortem Distribution and Redistribution

• Comprehensive tissue distribution studies to provide data on 

relationship between tissue and blood drug/metabolite 

concentrations, further characterization of chemical/biological 

mechanisms of PMR, specific chemical markers to provide 

evidence of PMR, development of mathematical relationships to 

evaluate PMR

27
Summary

Topic Title

1

Standard Practices for Method 

Validation in Forensic Toxicology

2

Standard Practices for Measurement 

Traceability in Forensic Toxicology

3

Standard Practices for Method 

Validation in Forensic Toxicology –

Breath Alcohol Measuring Instrument 

Calibration

4

Standard Practices for Quality Control 

in Forensic Toxicology

5

Guidelines for Opinions and 

Testimony in Forensic Toxicology

• Continue to coordinate 

efforts of SWGTOX with 

OSAC Toxicology 

Subcommittee

• Finalize unfinished 

SWGTOX documents

• Initiate development of key 

documents related to 

quality assurance in 

forensic toxicology

28