SWGDRUG
Meeting Minutes
July
10-12, 2012
Core
Committee Members (present):
Scott R. Oulton,
Chair, Drug Enforcement Administration
Sandra E. Rodriguez-Cruz,
Secretariat, Drug Enforcement Administration
Suzanne Bell,
Michael Bovens,
European Network of Forensic Science Institutes
Sylvia Burns, Private Forensic
Conor Crean,
United Nations Office on Drugs and Crime
Garth Glassburg,
American Society of Crime Laboratory Directors
Linda Jackson, Mid-Atlantic Association
of Forensic Scientists
Richard Laing, Health
Adriano Maldaner,
Jerry Massetti,
Northwestern Association of Forensic Scientists & CA Association of
Criminalists
Jack Mario, Northeastern
Association of Forensic Scientists & American Society for Testing Materials
Christian Matchett,
Southern Association of Forensic Scientists
Richard Paulas,
Midwestern Association of Forensic Scientists
Robert Powers, Connecticut
Department of Public Safety
Catherine Quinn,
Pamela Reynolds, Federal Bureau
of Investigation
Scott Vajdos,
Southwestern Association of Forensic Scientists
Angeline Yap Tiong
Whei, Asian Forensic Sciences Network
Udo Zerell,
Core
Committee Members (not present):
Eric Person,
Karen Phinney,
National Institute of Standards and Technology
Guests:
Betty Bleivik,
Note Taker, Drug Enforcement Administration
Tuesday,
July 10, 2012
Welcome/Introduction of Meeting
Guests/Review of Conference Agenda
SWGDRUG
chair Scott Oulton opened the meeting by welcoming
the committee members. Mr. Oulton thanked Sandra Rodriguez-Cruz for her work in
putting the meeting together. He noted
that it was challenging to find a space that met the group’s needs and also met
the requirements for meetings set by the Department of Justice. Mr. Oulton also
introduced invited guest Betty Bleivik (note taker).
SWGTOX Method Validation Draft Document
Mr.
Oulton stated that SWGDRUG will consolidate our
comments and send one response to SWGTOX.
He requested for comments to be collected, compiled and submitted by Ms.
Rodriguez-Cruz.
Core Committee Members Responsibilities
Mr.
Oulton gave an overview of the meeting agenda. The comments received for Supplemental
Document SD-5 (Reporting Examples) will be discussed. The goal is for the
core-committee to vote on the document by Thursday. The core committee was reminded that Supplemental
Document SD-4 (Measurement
Uncertainty for Purity Determinations in Seized Drug Analysis) was voted on at last meeting to
go out for public comment.
The
Reference Materials Verification and Education and Training sub-committees will
also be meeting to work on their pertinent sections of the SWGDRUG Recommendations.
MS Library Update
Mr.
Oulton thanked Angeline Yap Tiong
Whei for converting the mass spectral data into the
Shimadzu format. Mr. Oulton
stressed that SWGDRUG does not have the resources to validate submissions to
the MS library; therefore, users must be aware of the disclaimer posted along
with the library.
Mr.
Oulton informed the committee that Cayman Chemical
has provided SWGDRUG with data for incorporation into the SWGDRUG MS
Library. There is ongoing discussion
with Lipomed to do the same. Mr. Oulton also informed
the committee that DEA has purchased 154 reference materials from Cayman
Chemical. The DEA’s Special Testing and
Research Laboratory is validating these reference
materials with the goal of developing monographs for each of them. It is expected the data will be published
online within the next several months. This will provide the community a resource for
validating their reference materials.
This is especially important for bath salts and synthetic cannabinoids.
SWGDRUG Bylaws
Linda
Jackson discussed her participation in the Interagency Working Group and the
status of the creation of standardized bylaws for all SWGs. Some of the items being considered are the
establishment of term limits for members and procedures involved in removing
members for cause. Mr. Oulton stated that SWGDRUG will operate as is, putting any
changes on hold pending completion of the draft standardized bylaws. Ms. Jackson also stated that there are some
recommendations in the community to have the National Institute of Science and
Technology (NIST) oversee the SWG groups with the intent that all SWGs would
develop standards in a consistent manner.
Analogues
Mr.
Oulton led a discussion on analogues. The discussion focused on whether or not
SWGDRUG should have a formal statement on the subject and if so, should SWGDRUG
define what an analogue is or should the document only provide guidance. The committee discussed this topic at length
and whether or not SWGDRUG should even be involved with this subject, since in
many jurisdictions the courts ultimately decide a compound’s analogue
status. Mr. Oulton
indicated that he would consider creating a sub-committee to address this
topic.
Reporting Sub-Committee Update
Robert
Powers discussed the comments received regarding Supplemental Document SD-5
(Reporting Examples). The
sub-committee’s next step will be to address the comments and then make minor
revisions to the examples. It was
emphasized that SD-5 contains examples of reporting, not required formats. The committee may consider adding additional
examples to further illustrate SWGDRUG’s minimum recommendations.
Uncertainty Sub-Committee Update
Suzanne
Bell discussed the status of SD-4 (Measurement
Uncertainty for Purity Determinations in Seized Drug Analysis), and
stated that it should be completed in one day.
The document requires some editing, but no major changes.
Reference Materials Sub-Committee
Update
Sylvia
Burns stated that she has reviewed the relevant SWGDRUG Recommendations sections pertaining to Reference Materials (RM)
prior to this meeting; these will be discussed during the sub-committee
break-out session. Issues to be
discussed include RM-producing companies and the availability of RMs. The point was
raised that true “Certified Reference Materials” (CRM) for controlled
substances may not truly exist. Ms.
Burns emphasized that it is a laboratory’s responsibility to determine if a RM
is fit for purpose. Also, Ms. Burns
discussed adding to/amending the SWGDRUG Recommendations
to include a section on the use of RMs.
Ms.
Burns intends to distribute draft work products to the core committee for
discussion prior to tomorrow’s break-out session.
Education and Training Sub-Committee
Update
Rick
Paulas informed the core-committee that the
sub-committee has been compiling questions on different training subjects. During this meeting, the goal of the
sub-committee will be to review, select, modify, delete and add questions as
needed. Lastly, the sub-committee hopes
to select an appropriate format and prepare the document for dissemination.
European Network of Forensic
Science Institutes (ENFSI)
Michael
Bovens informed the core-committee that although
ENFSI’s training and education outline has been officially released, it is
currently only available on their members-only website. He indicated that since the outline is
completed, SWGDRUG could post the training outline on their website. He also provided an update for their project
regarding quantitative sampling.
SWGDRUG Survey
Suzanne
Bell suggested that she was going to have graduate students from
Sampling Calculator Presentation
Angeline
Yap Tiong Whei presented
recent issues encountered with ENFSI’s sampling calculator involving the use of
hypergeometric distribution. It was discovered that the calculator produces
results for small sample populations that may result in under sampling of
units. Users in her laboratory evaluated
their findings concluding that the results obtained were a consequence of
truncation and rounding events in Microsoft Excel. Ms. Yap Tiong Whei stated that her lab uses 3 different calculators to
determine sample size: general software, the CLIC calculator, and the ENFSI
calculator.
The
core-committee also discussed making the CLIC Hypergeometric
Sampling calculator available via the SWGDRUG website with permission from CLIC
and the calculator’s author John Gerlits.
ASTM Update
Scott
Oulton provided an ASTM update. He informed the core-committee that the clan
lab document, which was written with the help of CLIC, has been brought to ASTM
for acceptance as an international standard.
There is only one issue to address, and then it should go through the
ASTM vetting process without delay.
Jack
Mario discussed the application of hypergeometric
sampling to an actual case brought to court in Suffolk County, NY during April
2012. He presented some of the case
highlights, including trial preparation and training sessions.
International Forensic Strategic
Alliance (IFSA) Overview
Angeline
Yap Tiong Whei presented a
report on IFSA. She described how six
forensic science networks around the world have come together to form IFSA. IFSA’s vision is to create opportunities for
strategic collaboration across the global forensic science community. IFSA operates via annual meetings and
teleconferences.
Ms.
Yap Tiong Whei informed the
core-committee that IFSA would like to adopt a minimized version of the SWGDRUG
Recommendations for seized drug
analysis. This issue was discussed and
it was stressed that the SWGDRUG Recommendations
should not be used in a reduced form and must be adopted in their entirety, as
they were developed and adopted to reflect minimum standards. Under these circumstances, core committee
members agreed that IFSA is welcome to use and adopt SWGDRUG Recommendations.
The
core-committee briefly discussed translating the SWGDRUG Recommendations into other languages, but would first need to
evaluate the costs associated with such projects.
Kovat’s Retention Index Study Update
Angeline
Yap Tiong Whei discussed
the progress of establishing retention index information on the SWGDRUG
website. She continues collecting data
for dissemination.
Sub-Committee Break Out
The core committee
members broke out into their respective sub-committees until late afternoon.
Sub-Committee Review
Documents
containing preliminary revisions to the Recommendations
were emailed from the RM sub-committee to the core committee members for review
prior to tomorrow’s discussion.
The
Reporting Sub-committee reviewed the comments received from the public
pertaining to Supplemental Document SD-5 (Reporting Examples). There will be a brief discussion tomorrow
morning prior to the break-out sessions.
Wednesday,
July 11, 2012
Reporting Sub-Committee Update
Linda
Jackson discussed 3 comments received from the public during review of the
draft Supplemental Document SD-5 (Reporting Examples).
1.
Capitalization
of drug names. Discussion regarding the
use of upper vs. lower case letters resulted in the consensus that use of
either one is acceptable. Both upper and
lower case letters will be used in both examples (upper case in one, lower case
in the other).
2.
Weight
determination is listed in the test/technique category. Discussion ensued as to whether or not weight
determinations should be considered a test/technique. The committee agreed that it was a test and
that the example should be left as is, with weight categorized as a
“test/technique”.
3.
Analytical
tests/techniques used to identify the drug are listed in the examples, but
should a negative test/technique (or a test/technique not used to identify the
drug) be listed? Discussion of this
question resulted in a consensus that the examples should be left as is.
The
core committee also discussed the most appropriate ways to address the multiple
comments received from the public.
Should the comments and the committee’s responses be posted on the
website? Should the responses be emailed
only to those who made the comments? Who
should respond? Should SWGDRUG use a
statement such as “Comments were addressed and acted upon appropriately” or
“The reporting sub-committee considered every comment and responded
appropriately”? The Reporting
sub-committee will prepare a document and solicit feedback from the core committee
prior to potential posting.
Reference Materials Sub-Committee
Update
Sylvia
Burns discussed several of the issues the sub-committee is evaluating while
revising the SWGDRUG Recommendations
regarding RMs.
These are:
·
What
is acceptable and is it even possible to obtain a Certified Reference Material (CRM)
for drugs?
·
Allowing
laboratories to use RMs without verification if they were obtained from sources
that are accredited to ISO Guide 34
·
Allowing
laboratories to verify RMs via other means (for example, MS interpretation)
when comparison with published data is not possible
·
The
use of “literature” spectra for identification
·
Addition
of a section addressing the use of RMs
Sub-Committee Break Out
The core committee
members broke out into their respective sub-committees until the afternoon.
Reporting Sub-Committee Update
The
core-committee reconvened to discuss Supplemental Document SD-5 (Reporting
Examples) and the comments received during the public comment period. A total of 24 comments were received. The comments and corresponding responses had
been emailed to the core committee members for review prior to discussion. Linda Jackson renewed the discussion regarding
how SWGDRUG should disseminate the responses to public comments. If a document including comments and SWGDRUG
responses is posted on the SWGDRUG website, how long should it be made
available? The committee also discussed
multiple ways of addressing comments and those were considered but resulted in
no changes to the document.
Dr.
Robert Powers made a motion to accept Supplemental Document SD-5 (Reporting
Examples) and for it to be posted on the SWGDRUG website after editorial
changes are made. Scott Vajdos seconded the
motion. After no further discussions,
the motion passed unanimously.
Thursday,
July 12, 2012
Uncertainty Sub-Committee Update
Suzanne
Bell discussed Supplemental Document SD-4 (Measurement Uncertainty for Purity Determinations in Seized Drug
Analysis). The core committee was
reminded that the 1st version had already been approved to be posted
for public comment during the previous meeting. During this meeting, minor changes were made
to the document.
Christian
Matchett made a motion to withdraw the previous
motion to release the document for public comment as voted on at the last
meeting. Linda Jackson seconded the
motion. The core committee passed the
motion unanimously.
Jack
Mario made a motion to release the revised version of Supplemental Document
SD-4 (Measurement Uncertainty for
Purity Determinations in Seized Drug Analysis) out for public comment
for a period of 60 days pending editorial review. Linda Jackson seconded the motion. The core committee passed the motion
unanimously.
Analogues
Scott
Oulton led a discussion on the issue of controlled
substance analogues, reviewing and expanding on the issues previously raised. During the
discussion, Robert Powers made the comment that we can only talk about
structural similarities and that we need to make it clear that
physiological/pharmacological effects are significant and cannot be addressed
by SWGDRUG. Sylvia Burns asked that since we can only give information on
structural similarity, can we provide guidance to the community as to how to define
structural similarity? The core
committee discussed the role of the legal community and the fact that there are
different rules for different jurisdictions, i.e. states, federal governments,
countries, etc. regarding the definitions of controlled substance
analogues. Catherine Quinn proposed that
SWGDRUG’s efforts could concentrate on emphasizing what a forensic scientist
can testify to during these cases. It
was decided that SWGDRUG would go forward with the formation of an Analogue
Sub-Committee and the drafting of a guidance document for the forensic
community.
Sub-Committee Break Out
The core committee
members broke out into their respective sub-committees until late morning.
Analogue Discussion
Christian
Matchett furthered the analogue discussion by
presenting an example using the chemical structures of (methamphetamine and methiopropamine). A
discussion ensued involving the definition of structural similarity and how to
best address it.
Reference Materials Sub-Committee
Update
Sylvia
Burns presented the sub-committee’s proposals for additions/changes to the
SWGDRUG Recommendations.
Part
III B - Methods of Analysis/Drug Identification, section 3.5
Amend
section 3.5 to include what constitutes a “positive.” The core-committee discussed the proposal and
agreed with the ideas, but the wording needs some clarification. It was suggested to leave section 3.5 as is
and make the proposals its own section as 3.5.5
Other
comments included:
·
How
would a laboratory report a “positive” identification made, if no reference
material was available?
·
It
was emphasized that laboratories should understand
the chemical skills needed to make an identification via structural elucidation
using NMR or MS data
·
Catherine
Quinn suggested the use of 3 tiers or levels for classifying the use of
reference materials in a laboratory
Sub-Committee Break Out
The core committee
members broke out into their respective sub-committees until late afternoon.
SWGDRUG Website Update
Scott
Oulton reported that Supplemental Document SD-4 (Measurement Uncertainty for Purity
Determinations in Seized Drug Analysis) has been made available on the
SWGDRUG website. Core committee members
were reminded of their responsibilities to notify their respective
organizations about the posting and the 60-day public comment period.
The
core-committee was also notified that the revised version of Supplemental
Document SD-5 (Reporting Examples) was now posted, containing a link for
accessing the public comments received and the corresponding SWGDRUG
responses. The comments document will be
available on the website for approximately one year.
The
European Network Forensic Science Institute (ENFSI) training outline and the
CLIC Hypergeometric Sampling Calculator have also
been made available via the SWGDRUG website.
Sub-Committee Status Update
Mr.
Oulton announced the formation of the following
sub-committees and their members.
Reference Material Sub-Committee: Sylvia Burns (chair), Suzanne Bell, Conor Crean, Jack Mario, Karen Phinney, Pamela Reynolds, and Angeline Yap Tiong Whei. Analogue Sub-Committee (new committee):
Christian Matchett (chair), Linda Jackson, Scott Oulton, Robert Powers, Catherine Quinn, Sandra
Rodriquez-Cruz, and Udo Zerell. The SWGDRUG website will be revised to
reflect these sub-committee additions and changes.
Reference Materials Sub-Committee
Draft
revisions to the SWGDRUG Recommendations
will be finished and sent to the core committee within the next few
months. Members were asked to send their
comments directly to the sub-committee.
Further discussion of the RM document followed including the possibility
of doing an electronic vote or conference call before the next meeting in
January 2013.
Meeting Closeout
Sandra
Rodriguez-Cruz was tasked with the compilation of all comments regarding the
SWGTOX Method Validation draft document.
Ms. Rodriguez-Cruz will submit a formal response to SWGTOX on behalf of
SWGDRUG.
The
current SWGDRUG PowerPoint presentation is posted on the website. It was suggested that any future SWGDRUG
presentations by members be sent to Scott Oulton for
posting.
Possible
locations for the next SWGDRUG meeting were discussed. The next meeting is tentatively scheduled for
the week of January 7-11, 2013.
Mr.
Scott Oulton thanked all committee members for all
their hard work during this meeting. He
also thanked Sandra Rodriguez Cruz for all her hard work setting up this
meeting and Ms. Betty Bleivik for participating as
the note taker. Thanks were also
extended to the all sub-committee chairs.
Minutes respectively submitted by
Betty Bleivik