LRC Comments to ASTM E2329-14

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COMMENTS BY THE OSAC LEGAL RESOURCE COMMITTEE (LRC)

TO: Seized Drug Subcommittee of the Chemistry-Instrumental SAC

FROM: Lynn Garcia, LRC Liaison to Chemistry-Instrumental SAC

RE: LEGAL RESOURCE COMMITTEE (LRC) COMMENTS ON E2329-14

Response from the Seized Drugs Subcommittee

The OSAC Seized Drugs subcommittee recognizes and appreciates the comments received from 

the Legal Resource Committee (LRC) pertaining ASTM E2329-14, Standard Practice for

Identification of Seized Drugs. The following responses attempt to address and clarify some of 

the issues brought to our attention by the LRC.

The document in review (E2329-14) was original published by ASTM in 2004. The document

was originally published as Part IIIB of the Scientific Working Group for the Analysis of Seized 

Drugs (SWGDRUG) Recommendations, which are intended to assist forensic analysts and 

managers in the development of analytical techniques, protocols and policies. The SWGDRUG 

Recommendations are internationally recognized as minimum standards that may be 

supplemented to address unique jurisdictional laboratory requirements. 

The document under consideration is neither a test method nor a prescriptive standard. 

Therefore, many of the comments provided by the LRC members are not considered applicable. 

Also, this document is not intended to encompass all other related standards, terminology, 

validation documentation, etc. that may assist in its application. The field of seized drug 

analysis is an extensive one encompassing the subjects of sampling, chemical identification, 

presumptive and confirmatory analytical techniques, method validation, quantitative procedures, 

structure elucidation, measurement uncertainty, reporting protocols, and many others. It is 

unrealistic and impractical to attempt to include all these subjects into one single document, as 

the result would be an ineffective standard that would not be useful for practitioners. Efforts are 

already underway to address some of the aforementioned subjects via the publication of separate 

documents on the OSAC Registry.

There appears to be some misconceptions and misunderstandings regarding the OSAC process 

as well as the process in use by the standard development organization (SDO) under which this 

standard is published (ASTM). We believe that it would be useful to provide additional training 

regarding these procedures to not only members of the LRC but also members of other resource 

committees and individual discipline subcommittees.
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We understand the desire for these documents to be written such that they are more 

comprehensible to lawyers and judges. However, many of these documents under review have 

already been in the forensic community for over ten years and they were originally drafted with 

the goal of providing useful minimum standards for seized drug analysts. In fact, there are many 

seized drug laboratories throughout the world that use this document (as well as the SWGDRUG 

Recommendations) as a foundation for their policies and procedures. It is our strong belief that

attorneys and judges have the ability to consult scientists in order to interpret a scientific 

document, much in the same way as a scientist would consult an attorney to interpret a legal 

document. Serious consideration is being given to all the comments provided by the LRC 

members. However, we believe that making significant changes to the document in order to 

address the resource committees would take away too much from the original technical and 

scientific intent of the document.

The Seized Drug Subcommittee of the Chemistry-Instrumental SAC is proposing that ASTM 

E2329 − 14 (“Standard Practice for Identification of Seized Drugs”) be placed on the OSAC 

Repository of Standards and Guidelines.

Our comments are primarily intended to enhance the value of the Standard to the legal 

community. This Standard will be most helpful if it not only helps assure high quality results in 

the laboratory, but also is written to show how work performed in accordance with the Standard 

is both well grounded in theory and data and that it is presented within the boundaries of “the 

knowledge and experience of [the expert’s] discipline.”1 Consequently, the comments are 

intended to address four questions that are important to the legal reception of the Standard: 

(1) Is the Standard written as clearly as possible, and without undefined technical terms and 

symbols, so as to enable lawyers and judges to grasp the main ideas and requirements set forth? 

(2) Does the Standard describe in detail how the peer-reviewed and readily available scientific 

literature establishes the validity of the assumptions underlying the scientific tests and the 

interpretation of test results? 

(3) Does the Standard list the limitations of the tests and results and provide for expressions of 

the uncertainties in measurements and inferences drawn from them? 

(4) Does the Standard include recommendations or requirements for the creation and retention of 

documentation of the test and the contents of reports, including the scientific limitations of the 

tests and related conclusions or inferences? These are matters of both technical merit and legal 

 

1 Kumho Tire Co. v. Carmichael, 526 U.S. 137, 148 (1999) (quoting Daubert v. Merrell Dow Pharms, Inc., 509 U.S. 

579, 592 (1993)).
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importance. Although the LRC is not able to assess the scientific merit of a Standard, our review 

encompasses whether a Standard makes a prima facie case for the validity of the methods and 

legal utility of the kinds of expert opinions that a Standard contemplates.

The LRC received feedback from the FSSB recently that it would be more useful for LRC 

members to provide consolidated comments as opposed to providing the comments of 

individual members and indicating which other members of the LRC join in the comments. 

We did not have sufficient time to attempt this before comments on E2926-13 were due. 

However, we have been discussing possibilities for meeting this request and will strive to 

make our comments as useful as possible to the FSSB and other interested readers.

Comments by LRC Member Jennifer Friedman:

I do not believe this standard is ready to be published in the OSAC registry. My reasons for this 

opinion are set forth below.

1.4 This is a proposed standard therefore it should be described as a standard not a practice. 

Additionally, this seems to suggest that it would be appropriate not be follow the standard if the 

analysts “experience, education, or training dictated it should not be followed. 

Not persuasive. This is standard language incorporated into ASTM documents. The intent is to 

prevent an individual, not possessing the appropriate “experience, education, or training,” from 

using the document without proper scientific judgment. Neither is this section meant to imply 

that the standard should be ignored, but rather that the standard should be used in conjunction 

with existing knowledge. Describing something as a “Standard Practice” should not preclude it 

from moving forward to the OSAC Registry of Standards. 

3.1 I believe there should be a standard glossary of terms used by all committees in generating 

standards. To the extent a term is not included in this glossary, it should be included in the 

standard or if the glossary defines a term differently than is used in the standard, it should be 

defined in the standard.

Not persuasive. Separate on-going efforts within the OSAC are geared towards the development 

of a general Terminology document that would include many of the terms in this Standard 

Practice. The current absence of such document should not preclude others from being added to 

the OSAC Registry.

4.2 this standard references other standards that may or may not be included in the OSAC 

registry. This is a problem. Additionally, this statement makes no sense,” in the absence of 

unforeseen error, an appropriate analytical scheme effectively results in no uncertainty in 

reported identifications.” Errors are always unforeseen. This does not tell the reader anything 

about error rates or limitations of the technique. 
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Not persuasive. It is unrealistic to expect all references found in a document to be already 

included in the OSAC Registry, as submissions have only started. In addition, not every 

document that is of value to forensic chemists is expected to be included in the registry, e.g., 

textbooks, published papers, etc. To disallow reference to other technically sound and useful 

documents, just because they are not placed in the registry yet, would not be of service to the 

forensic or legal communities. 

Editorial. The Seized Drug subcommittee intends to clarify the quoted language pertaining to 

uncertainty and error during the next ASTM revision of this document.

6.1.6 If this standard is going to include a direction that a lab use quality assurance measures, the 

measures that should be used must be specified. Additionally, the use of two samplings, bar 

codes, witness checks, good laboratory practices such as the use of controls should not be 

suggestions they should mandatory.

Not persuasive. This is a document stating minimum requirements, not a prescriptive standard. 

Quality assurance measures depend on laboratory, jurisdiction, and accreditation. The intent of 

the current document is to require laboratories to implement quality assurance measures as part 

of their quality system. The specific listing of such measures would fall under the scope of a 

separate document, most likely generated by the specific laboratory.

6.1.7 and 6.1.8 should cite to published validation studies in which the various techniques were 

tested and the limits and error rates of the techniques described.

Not persuasive. Again, this document is not a prescriptive standard. Citing published validation 

studies for all the dozens of possible and scientifically valid techniques a laboratory could use is 

outside the scope of the document. The vast majority of these techniques have been in use for 

decades, extensively published and strongly based on physical scientific principles. In addition, 

validation documentation is the responsibility and accreditation requirement of the laboratory 

performing the analysis, and it would vary from laboratory to laboratory in order to be fit-forpurpose and to fulfill jurisdictional requirements.

The following members of the LRC agree with comments made by Jennifer Friedman:

Barry Scheck joins in Jennifer Friedman’s comments.

Comments by LRC Member David Kaye:

This ASTM Practice prescribes some “uniform methods, actions, practices, or processes, 

protocols” (or some parts of them). Being ASTM-approved, it is included in “the OSAC Catalog 

of External Standards and Guidelines [which] is a collection of standards, guidelines and other 

documents applicable to forensic science.” NIST, OSAC Catalog of External Standards and 
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Guidelines, Dec. 10, 2014 (updated May 15, 2015), 

http://www.nist.gov/forensics/osac/standards-guidelines-catalog.cfm (emphasis added). I am 

informed that this fact makes it appropriate to consider the Practice for inclusion in the Registry 

even if it lacks the specificity and terminology for Standards and Guidelines discussed in 

previous OSAC meetings.

The Practice does offer some useful guidance, but it lacks the detail and specificity to be a 

“controlling legal standard” within the meaning of Daubert v. Merrell Dow Pharmaceuticals, 

509 U.S. 579 (1993). Consequently, I do not see that much is to be gained by placing it in the 

Registry. To be sure, OSAC approval would signal that the methods alluded to are generally 

accepted, but the methods in question are hardly novel.

Perhaps I am underrating the power of the document to improve laboratory practices, but rather 

than place this particular Practice on the Registry, I believe that the SAC’s expertise and efforts 

would better be devoted to producing a controlling standard that specifies more fully how 

analytical procedures are to be performed and that supplies advice on reporting and testifying. 

In the hope that the SAC will accept the challenge to “develop new standards and guidelines for 

the OSAC registries to replace current documents in the catalog,” NIST, supra, more detailed 

comments follow. Some suggestions as to revisions that simply would improve clarity are 

placed at the end.

1. Concerns About Content

Part 2 (referenced documents) is limited to a set of “Guides” and one SWGDRUG document. 

Are no other publications on the test procedures worth referring to? The Standard should show 

how it flows from and is supported by a body of cited scientific studies. (Even if the Practice 

were to be incorporated into the Registry as an off-the-shelf product to be replaced later, the 

SAC and the FSSB should consider including an appendix or introduction to the Standard as it 

appears in the registry. Presumably, that explanatory document would not have to be approved 

by ASTM.) 

Not persuasive. It appears the intent of section 2 is misinterpreted. This is not a prescriptive 

standard; therefore, the inclusion of references to “other publications on the test procedures” is 

not applicable, because this document does not describe a specific test procedure. Section 2 is 

standard in ASTM documents, intended to provide the reader with an easy-to-find location where 

all documents referenced in a standard are listed. Interestingly, the Seized Drug subcommittee 

considers this comment (requesting inclusion of further references) somewhat contradicting the 

comment provided by the previous LRC reviewer who was critical of including references to 

documents that are not in the OSAC Registry yet.

Not sure what is being requested by “FSSB should consider including an appendix or 

introduction to the Standard as it appears in the registry”. We believe this document stands on 

its own and is comprehensible to practitioners, the intended audience. E2329 is a broad 

document that provides laboratories with a framework to select an appropriate analytical 

scheme that includes all techniques and methods needed to effect a drug identification. While 
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there may be other documents to cite, SWGDRUG was the leader in identifying the need for 

providing this guidance. Indeed the SWGDRUG Recommendations are cited by state 

legislatures, other professional working groups and governments around the world as an 

authoritative guideline for the practice of drug analysis. Before the SWGDRUG publication, 

there were no equivalent guidance documents that unified the profession. It is appropriate to 

cite it as it was the first to cohesively identify paths toward robust drug analysis.

Section 4.1.1 states that “As these are minimum requirements, it should be recognized that they 

may not be sufficient for the identification of all drugs in all circumstances. Within these 

requirements, it is up to the individual laboratory’s management to determine which combination 

of analytical techniques best satisfies the requirements of its jurisdiction.” The meaning of 

“minimum” is unclear. Presumably, it points to a set of conditions that are necessary but not 

sufficient for a drug identification. But where is this minimum stated? Or is the idea that at least 

one of the techniques that are described must be used? That none of them need be used if 

management has something better in mind? That if any of them are used, the “practice” specifies 

a minimum set of requirements for using it? A Standard or Guideline should be clear about what 

must be done when. Section 6 is very useful in this respect, and might be referred to here, but it 

has some limitations noted below. 

Not persuasive. The intent of section 4.1.1 is to emphasize the requirements listed which 

establish the minimum amount of testing a laboratory must do. In addition, the subsequent 

caveat further clarifies that the minimum testing may in fact not be enough for a particular drug 

identification and the laboratory must do more testing in those scenarios. The establishment of 

minimum testing criteria is the heart of this document, as stated in section 5, Table 1 and 

sections 6.1.1 through 6.1.5.

The observation in section 4.2 that “validated methods” must be used is fine, but without a 

specification of what those are or what must be done within an individual laboratory, it provides 

no real guidance. To be sure, the section refers to a separate standard that might contain this 

information, but that Standard has not been approved for the repository. Would approving this 

one automatically effectively approve that one? If Standards are interdependent, must not both of 

them be considered for incorporation into the repository at the same time? 

Not persuasive. Specific methods are validated and documented at the laboratory level to 

comply with individual accreditation and jurisdictional requirements. A separate document, 

E2549, addresses how validation is to be conducted and used. As mentioned above, E2329 

establishes minimum requirements, including that laboratories must use validated methods. The 

requirements, procedures and documentation of the actual validation studies will depend on the 

actual test/technique being validated. All these are outside the scope of this document.

Section 4.2 also states that “It is expected that in the absence of unforeseen error, an appropriate 

analytical scheme effectively results in no uncertainty in reported identifications.” This 

somewhat wordy sentence comes directly from ASTM E2764−11. Neither document defines 

what it takes to expect “no uncertainty” or what an “effective uncertainty” of zero really means. 

The dichotomy in the latter document between quantitative measurements (which “have an 
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associated uncertainty”) and qualitative one (which somehow do not) is not easily understood 

and is not consistent with some court opinions from other forensic-science fields.

Editorial. The Seized Drug subcommittee intends to clarify the quoted language pertaining to 

uncertainty and error during the next ASTM revision of this document.

Section 6.1.2.1 states that “Laboratories shall define the acceptance criteria for these [botanical] 

features for each examination.” On what basis? The “practice” here sounds like a 

recommendation to do the right thing. Section 6.1.3 does not offer much more in the way of 

meaningful guidance.

Not persuasive. These acceptance criteria will differ from laboratory to laboratory and should 

be documented in their individual laboratory procedural requirements. In most cases, it will 

depend on specific jurisdictional requirements. Section 6.1.3 is intended to address laboratories 

where botanical identifications are performed by botanists, not forensic chemists. Again, it is 

not the purpose of this Standard Practice to dictate what criteria are to be used, simply to 

establish minimum identification requirements.

Section 6.1.6 calls for quality assurance, but it only gives examples of what would suffice. It may 

be that other Standards on quality assurance generally cover the topic (in which case it is not 

clear why this Practice also tries to). 

Not persuasive. Providing examples of quality assurance measures enhances the interpretation 

of the document and is not expected to have any inherent issues.

Section 6.1.8 states that “The chosen analytical scheme shall demonstrate the identity of the 

specific drug present and shall preclude a false positive identification and minimize false 

negatives. Where a scheme has limitations, this shall be reflected in the final interpretation (see 

Practice E2764).” Precluding all false positives would be wonderful, but is it possible? There is 

inevitably a trade-off between false positives and false negatives, and rarely is there any realistic 

way to preclude all false positives.” I saw nothing in ASTM E2764 that solves this fundamental 

problem. 

Editorial. The subcommittee intents to clarify the language in a future document revision.

Another section should address what kinds of conclusions should, can, or must be in reports and 

testimony. I doubt that an assurance that the method precludes all false positives, with no studies 

to establish this assertion of infallibility, is advisable. If this standard is not intended to offer any 

guidance whatsoever on how to present a determination of the nature of a compound, its limited 

scope should be made explicit and justified on the ground that another document will deal with 

the problem of incorporating statements of uncertainty into these determinations. 

Not persuasive. This is to be the scope of a separate document.

2. Drafting Problems
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Section 1.1 states that “This practice describes minimum criteria for the qualitative analysis 

(identification) of seized drugs.” The term “qualitative analysis” is not normally equivalent to 

“identification.” For example, determining the color of a solution by looking at it is a qualitative 

analysis. Measuring the wavelength of light reflected from the solution is quantitative. Either 

might help identify something.

Not persuasive. In the field of chemistry, the terms qualitative and quantitative analysis are 

distinctly used to refer to tests providing identification and purity/concentration of chemical 

component(s), respectively. They shall not be confused with the terms qualitative and 

quantitative result. Yes, “measuring the wavelength reflected from the solution” is a 

quantitative result (that is, it produces a number). However, that numeric result could be used 

solely as a qualifying characteristic of the compound under investigation or as a measure of its 

concentration/purity in the solution. The latter result would only be valid under appropriately 

validated experimental conditions where, among others, require comparison with a knownconcentration positive control. In the chemistry discipline, a quantitative analysis cannot be 

performed without prior (or simultaneous) qualitative testing. In other words, analysts cannot 

test how much of a compound is present without first identifying which compound is present.

Section 1.4 states that “This practice does not replace knowledge, skill, ability, experience, 

education or training and should be used in conjunction with professional judgment.” Either this 

goes without saying or it is overbroad. Does it mean something more than that in using an 

analytical scheme or technique, knowledge, skill, ability, experience, education or training is 

required. If so, what?

Not persuasive. Previously considered.

The disclaimer in section 1.5 does not seem to achieve any legal objective. It is hard to see how 

any reader would think that a “standard . . . purport[s] to address all of the safety concerns.” 

Stylistically, the phrase “all of the safety concerns, if any” is awkward. Every other section in 

this part uses the word “practice” to refer to the document or its content. This one uses 

“standard.” Why the change?

Not persuasive / not germane. This is a common disclaimer included in ASTM documents. Not 

sure why its inclusion is interpreted to have a legal objective. This document has been identified, 

per ASTM protocol, as a Standard Practice.

Section 3.1 departs from the ideal of having a set of definitions of important terms developed 

through the OSACs. That goal is not essential, but the definitions in question should be part of 

the document. They could go in an appendix.

Not persuasive. Separate on-going efforts within the OSAC are geared towards the development 

of a general Terminology document that would include many of the terms in this Standard 

Practice. 
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Section 6.1.4 requires “data that are reviewable” for some techniques. It seems like a 

documentation requirement rather than an identification criterion. These requirements, along 

with ones for other techniques, might belong in a new section.

Not persuasive. This is not stated as an identification requirement, but as a documentation 

requirement that goes along and depends on the techniques and methodologies selected to 

achieve identification. The documentation provides the evidence of identification.

The following members of the LRC agree with the comments made by David Kaye: 

Barry Scheck and David Moran join in all of David Kaye’s comments.

Ron Reinstein joins in all of David Kaye’s comments except the comment regarding Section 1.4. 

Judge Reinstein believes the section should be clarified but not deleted. Judgment, training and 

experience are important but must be used in conjunction with the test method (but not in place 

of it).

_______________________________________________

Comments by LRC Member Barry Scheck:

Barry Scheck would like to emphasize concerns expressed in the comments by Jennifer 

Friedman and David Kaye that the deficiencies in the statistical explanations offered is troubling 

and not ready for court, whether one is in a Frye or Daubert jurisdiction. These should be 

rejected from the OSAC Registry and, hopefully, the OSAC subcommittee and/or ASTM will 

revise the proposed standards to follow the template laid out in the Technical Merit Worksheets. 

The requirement of general acceptance in the scientific community, particularly among 

statisticians, cannot be met, nor the requirements of clearly identifying limitations and 

weaknesses in the methodology or an explanation of how it is "fit for purpose."

Not persuasive. Not sure what is referred to as “deficiencies in the statistical explanations 

offered”. There are no statistical explanations included in this document as they would only be 

applicable to a test method or procedure – which this document is not. The minimum 

requirements stated in this document have been nationally and internationally accepted by seized 

drug laboratories and courts for over 10 years as an ASTM publication and over 15 years as a 

SWGDRUG recommendation. Its fitness for purpose has therefore been demonstrated.

It is unrealistic to expect previously vetted and published ASTM documents to fulfill the 

requirements just recently established by OSAC, as they are completely separate institutions.

This comment does not offer any specific explanation as to how this document does not meet “the 

requirement of general acceptance in the scientific community, particularly among 

statisticians”. And again, it appears the document has been misinterpreted as describing a 

particular methodology.

DISCLAIMER: The failure of any member of the Legal Resource committee (LRC) to 

provide a comment, identify a legal issue or join in another LRC comment should not be 
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interpreted as a disagreement or endorsement of the comment, the standard or its legal 

sufficiency.