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OSAC Seized Drugs Subcommittee Response to Public Comment on the Replacement of ASTM E2548-

11e1 with E2548-16 on the Registry:

ASTM E2548-11e1 “Standard Guide For Sampling Seized Drugs for Qualitative and Quantitative Analysis” 

is currently on the OSAC Registry. This standard has been superseded at ASTM by E2548-16; as such, the 

OSAC Seized Drugs Subcommittee submits ASTM E2548-16 to replace the historical version of the 

standard on the OSAC Registry. Before discussing the merits of E2548-16, we would like to make clear that 

we agree with the general sentiment expressed in the public comments that this standard would be wellserved by a comprehensive revision in collaboration with statisticians who have specific expertise in 

sampling and attorneys who have interest and experience with these issues, such as David Kaye (the LTG 

chair). Indeed, to that end we have opened a new item in ASTM (WK75229) to begin the redrafting 

process. 

We feel it is important to replace the superseded E2548-11e1 document with the E2548-16 version on 

the Registry at this time because several improvements were made in the E2548-16 document and it is in 

the best interest of the forensic community for OSAC to refer individuals to the current version of the 

document. The improvements made in E2548-16 include:

● Random sampling is necessary when making an inference about a population. This is now a 

requirement in E2548-16, but was only a recommendation in the E2548-11 version.

● E2548-11 does not provide information on the possibility of making an inference to the population 

from non-statistical sampling whereas E2548-16 does.

● Figure 1 has been improved in E2548-16, as acknowledged by Commenter 1.

The challenge we face in terms of timing is that the process of revising the standard through both the 

OSAC and ASTM processes will take 3-5 years and we feel the addition of the compulsory language 

regarding random sampling and the improvement to figure 1 are important enough changes to support 

replacement of E2548-11e1 with E2548-16 on the Registry.

Public comments received regarding this action have been transcribed below along with the 

subcommittee adjudication and response to each item.

Adjudication of Public Comments:

Commenter 1:

1. Neither ASTM E2548-11e1 nor its successor, ASTM E2548-16, belong on "a repository of highquality, technically sound published ... standards for forensic science." The basis for this 

conclusion can be found in the attached memorandum. If the choice is between allowing ASTM 

E2548-11e1 to remain on the Registry and replacing it with ASTM E2548-16 pending a major 

overhaul, however, the pragmatic question of whether the 2016 version belongs on the Registry 

is more complex.

Subcommittee Response: We understand this comment but believe the improvements made in 

E2548-16 over the superseded E2548-11e1 version, in addition to the benefit to the community for 
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OSAC to refer laboratories to the current version of a standard, warrant the replacement of the 

historical version of the standard with the revised version of the standard on the Registry.

2. In 2016, six OSAC Legal Resource Committee members submitted public comments opposing the 

addition of ASTM E2548-11e1 (Standard Guide for Sampling Seized Drugs for Qualitative and 

Quantitative Analysis) to the OSAC Registry. Despite these comments and criticism from other 

OSAC units, OSAC added the standard to the Registry (effective April 3, 2017). ASTM International 

made minor changes to the 2011 Standard Guide in ASTM E2548-16. This superseding version has 

been proposed for addition to the Registry. It is difficult to say whether the 2016 version should 

be added to the Registry. On the one hand, it contains several improvements, and it can be argued 

that an improved version—no matter how slight the improvement—should replace the 2011 

version on the Registry. On the other hand, a negative outcome would underscore the need to 

finally arrive at a standard that adequately addresses the concerns that lawyers, statisticians, and 

psychologists have voiced.1

Subcommittee Response: Unfortunately, the revisions to ASTM E2548 were already underway at 

ASTM when E2548-11e1 was submitted for registry approval in 2016, and the comments received 

through the OSAC process were not able to be incorporated at the SDO at that time. A work item 

has been opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will form a task 

group and invite a statistician and an LRC member into the task group to participate in the drafting 

of the revised document. The challenge faced is that the process of revising the standard through 

both the OSAC and ASTM processes will take 3+ years and we feel it is important to replace the 

superseded E2548-11e1 document with the E2548-16 version on the Registry since several 

improvements were made in the E2548-16 document and it is in the best interest of the forensic 

community for OSAC to refer individuals to the current version of the document. 

3. Without trying to resolve the Registry-approval question, these comments reiterate several of the 

technical objections to the standard and offer further observations so that they will remain clearly 

in sight. The major, interrelated, problems in ASTM E2548-16 are the failure: (1) to state clearly 

that probability sampling is required to permit valid inferences about population features (the 

technical term is “parameters”); (2) to define basic terms; (3) to use standard terms (in the 

statistics literature) for concepts; (4) to give some guidance on what values for the confidence 

coefficient or related criteria are scientifically acceptable in picking sample sizes using standard 

statistical methods; and (5) to offer guidance on how to express sampling uncertainty in either 

the frequentist and Bayesian frameworks to which the Standard Guide alludes.

Subcommittee Response: Persuasive. However, one of the major improvements to E2548-16 is that 

5.6.1.2 now requires random sampling for statistical sampling approaches whereas this was only 

a recommendation in the E2548-11 version. The OSAC Seized Drugs Subcommittee supports a full 

revision of the standard. To that end, a work item has been opened at ASTM (WK75229) and the 

OSAC Seized Drugs Subcommittee will form a task group, and invite a statistician and an LRC 

member into the task group to participate in the drafting of the revised document. The challenge 

faced is that the process of revising the standard through the OSAC and ASTM processes will take 

1 A paragraph at the end of the Guide states that it “must be reviewed every five years and if not revised, either 

reapproved or withdrawn.” The five-year review should occur next year, making it unclear why it is urgent to act 

on a 2016 version whose withdrawal or replacement is imminent.
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3+ years and we feel the addition of the compulsory language regarding random sampling is an 

important enough change to support replacement of E2548-11e1 with E2548-16 on the Registry.

4. Because the Standard Guide’s discussion of statistical reasoning is vague, laboratories will have to 

consult other sources to know what to do, making the Guide useful primarily as a bibliography. 

OSAC and ASTM should work toward having an easily understood document for drug chemists 

who want to develop sampling plans and present the results of tests on a sample of items 

correctly. Therefore, the best strategy might be to bring in a statistical expert on sampling theory 

and methods to reorganize and rewrite this Standard Guide rather than to continue making 

patchwork changes and revisions. 

Subcommittee Response: Not persuasive as to this version, but will be considered as part of the 

full revision of the standard. This particular ASTM standard is a guide. Per ASTM requirements, 

guides are a compendium of information or series of options that do not recommend a specific 

course of action. However, we do recognize the importance of sampling in forensic laboratories 

and the importance of providing easily understood guidance to the community. As such, the goal 

of the planned revisions to the standard will be to change the standard from a guide into a practice 

which per ASTM requirements is a set of instructions for performing one or more specific 

operations that does not produce a test result. As previously stated, we agree including an expert 

in sampling theory is the best course of action for drafting the new item. 

5. “1.1 This guide covers minimum considerations for sampling of seized drugs for qualitative and 

quantitative analysis.”

This is not a precise statement of the scope of the Standard Guide. What is a “minimum 

consideration”? Depending on how one construes the phrase “minimum consideration for 

sampling,” the statement of scope is not complete. The Guide also has sections on the 

documentation (§ 7) and reporting (§ 8) of the sampling part of the laboratory’s work. These 

exceed the stated scope. At the same time, the Guide lacks a parallel section on testimony on the 

nature and outcomes of the laboratory’s sampling. The scope section should outline the full scope 

and the important topics that are left out. 

Subcommittee Response: Editorial - does not critically impact the interpretation of the standard. 

The phrase “minimum considerations for sampling” is meant to encompass the entire sampling 

process to include the documentation and reporting of any sampling conducted by the forensic 

science practitioner. However, we do recognize the importance of testimony in relation to 

sampling and the planned revisions to the standard will incorporate a testimony section. The OSAC 

Seized Drugs Subcommittee has also begun work on a separate testimony standard.

6. “3.2 The principal purpose of sampling in the context of this guide is to answer relevant questions 

about a population by examination of a portion of the population. For example: What is the net 

weight of the population? What portion of the units of a population can be said to contain a given 

drug at a given level of confidence?”

a. The first sentence is not quite correct. The purpose of sampling is merely to produce a 

representative sample for analysis. The combination of sampling, analysis 

(measurement), and interpretation gives an answer to (or input that helps to answer) a 

legally relevant question without having to analyze every unit in the population.
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Subcommittee Response: Editorial - does not critically impact the interpretation of the 

standard.

b. “Population” should be defined in a new section that defines technical terms. The 

definition can be taken from one of the references or a statistics text. Same for “unit.”

Subcommittee Response: Not persuasive. Both terms are defined in ASTM E1732 

“Standard Terminology Relating to Forensic Science”, which is referenced in E2548-16. 

However, we do agree that a terminology section of terms specific to the standard would 

be beneficial and strengthen the standard; the planned revisions to the standard will 

incorporate a terminology section.

c. The question “What is the net weight of the population?” should be “What is the net 

weight of a proscribed substance in the population?”.

Subcommittee Response: Editorial - does not critically impact the interpretation of the 

standard. Discussions with the commenter revealed the issue is with the “of the 

population” phrase and the suggested change is to “all items in the population”. 

d. “Level of confidence” should be defined. Does it refer only to the value of a confidence 

coefficient in a frequentist interval estimate? To a posterior probability in a Bayesian 

credible region? Both?

Subcommittee Response: Editorial. There is a discussion of the term in E1732, however, a 

terminology section of terms specific to the standard would be beneficial and strengthen 

the standard; the planned revisions to the standard will incorporate a terminology section.

7. “3.3 By developing a sampling strategy and implementing appropriate sampling schemes, as 

illustrated in Fig. 1, a laboratory will minimize the total number of required analytical 

determinations, while ensuring that all relevant legal and scientific requirements are met.”

a. “Sampling strategy” and “sampling scheme” should be defined. Neither phrase is 

common in statistics texts. There may be better terms.

Subcommittee Response: Editorial. These terms are used within seized drugs forensic 

laboratories, and although each term is discussed within the standard, we agree that a 

terminology section of terms specific to the standard would be beneficial and strengthen 

the standard; the planned revisions to the standard will incorporate a terminology section.

b. This subsection presumes that there is no conflict between scientific and legal 

requirements. In any case, if “appropriate” means a procedure that reduces the number 

of units sampled to the minimum that is reasonably likely to estimate a parameter with 

scientifically and legally satisfactory precision, then the sentence should be rewritten to 

express that objective.

Subcommittee Response: Persuasive. In the seized drug discipline, not all sampling 

strategies involve estimating a parameter. We realize that the term ‘sample’ and 

‘sampling’ as used in the standard may not be how the terms are defined in the statistics 

community. Seized-drug practitioners historically refer to both sample selection and 

sampling as “sampling strategies”. Based on this comment, we believe the standard in its 

current form could be improved in the delineation of these two concepts. A terminology 
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section will aid in this understanding and this comment will be considered during the fiveyear revisions to E2548-16 (ASTM WK75229). 

We recognize that terminology and the distinction between sample selection and 

sampling is a fundamental issue within the standard that we agree needs to be addressed. 

We understand that the terms “statistical and non-statistical sampling” may be unclear 

to some readers and may be interpreted differently by various disciplines. To that end, a 

work item has been opened at ASTM (WK75229) and the OSAC Seized Drugs 

Subcommittee will form a task group to revise the document. The challenge faced is that 

the process of revising the standard through the OSAC and ASTM processes will take 3+ 

years and we feel the addition of the compulsory language regarding random sampling is 

an important enough change to support replacement of E2548-11e1 with E2548-16 on the 

Registry. 

8. “4.1 An appropriate sampling strategy is highly dependent on the purpose of the investigation, a 

customer’s request, and the anticipated use of the results. Laws and legal practices form the 

foundation of most strategies and shall be taken into account when designing a sampling scheme. 

Therefore, specific sampling strategies are not defined in this guide.”

The paragraph concludes with a non sequitur. Specific sample designs can and should be defined 

and discussed in a Standard Guide. Various legal constraints and customer requests can be 

enumerated, and guidelines can be provided for the enumerated situations. Doing so would 

supply more useful guidance than self-evident remarks such as “legal practices ... shall be taken 

into account.”

Subcommittee Response: Not persuasive as to this version, but will be considered as part of the 

full revision of the standard. This particular ASTM standard is a standard guide. Per ASTM 

requirements, guides are a compendium of information or series of options that do not 

recommend a specific course of action. However, we do agree that the standard could be improved 

and provide additional guidance to the reader and the goal of the planned revisions to the 

standard will be to change the standard from a guide into a practice to provide additional 

information. Examples may also be considered for an appendix to the standard as well.

9. “4.2.1 Sampling may be statistical or non-statistical. NOTE 1—For the purpose of this guide, the 

use of the term statistical is meant to include the notion of an approach that is probability-based.”

Normally, the word “statistical” means “relating to the use of statistics,” and a statistic is a number 

derived from or characterizing data (such as a batting average). In general (and as in the example 

of a batting average), the data need not be acquired by a method that involves the application of 

the mathematical theory of probability at some stage (if that is what “an approach that is 

probability based” means). Of course, one can choose to redefine a term to depart from its normal 

usage in science and ordinary life, but there is no reason to do so when a perfectly good term (in 

this case, “probability sampling”) is available in the statistical literature.

Subcommittee Response: Editorial. The term is defined in NOTE 1 as referring to probability-based 

sampling, however, we recognize that terminology and the distinction between sample selection 

and sampling is a fundamental issue within the standard that we agree needs to be addressed. 

We understand that the terms “statistical and non-statistical sampling” may be unclear to some 

readers and may be interpreted differently by various disciplines. To that end, a work item has 
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been opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will form a task group 

to revise the document. The challenge faced is that the process of revising the standard through 

the OSAC and ASTM processes will take 3+ years and we feel the addition of the compulsory 

language regarding random sampling is an important enough change to support replacement of 

E2548-11e1 with E2548-16 on the Registry.

10. “4.2.1.1 In many cases, a non-statistical approach may suffice. The sampling plan shall provide an 

adequate basis for answering questions of applicable law. For example, “Is there a drug present 

in the population?” “Are statutory enhancement levels satisfied by the analysis of a specified 

number of units?”

The term “sampling plan” should be defined. How does it differ from a “sampling scheme,” 

“sampling strategy,” and “sampling procedure”? Figure 1 has all these terms in it, but most of 

them are not defined explicitly and clearly. (“Sampling scheme” is defined in § 5.1.)

Subcommittee Response: Editorial. These terms are used within seized drugs forensic laboratories, 

and although each term is discussed within the standard, a terminology section of terms specific 

to the standard would be beneficial and strengthen the standard; the planned revisions to the 

standard will incorporate a terminology section.

11. ”4.2.1.2 If an inference about the whole population is to be drawn from a sample, then the plan 

shall be either statistically based or have an appropriate statistical analysis completed and limits 

of the inference shall be documented.”

The phrase “or have an appropriate statistical analysis completed” has been added since 2011. 

But what “appropriate statistical analysis” will permit a statistical inference from a sample to the 

population in the absence of a probability sample? In some research, non-probability samples are 

treated as if they were probability samples, but it is not necessary to make that analogy if 

probability sampling is feasible, as it seems to be here. (If it is not always feasible, those situations 

should be identified.)

Subcommittee Response: Persuasive. We agree that the standard could be improved and provide 

additional guidance to the reader and the goal of the planned revisions to the standard will be to 

change the standard from a guide into a practice to provide additional information. To that end, 

a work item has been opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will 

form a task group to revise the document. The challenge faced is that the process of revising the 

standard through the OSAC and ASTM processes will take 3+ years and we feel the addition of the 

compulsory language regarding random sampling is an important enough change to support 

replacement of E2548-11e1 with E2548-16 on the Registry.

12. “4.2.2 Selected units shall be analyzed to meet Practice E2329 if statistical inferences are to be 

made about the whole population.”

ASTM E2329 describes minimum requirements for qualitative analysis. It is not obvious why these 

requirements for identifying compounds do not apply to the analysis of every unit in a census of 

the population. Moreover, this provision seems beyond the scope of a standard on sampling. It 

concerns measurements or observations on the items in a sample.
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Subcommittee Response: Not persuasive. Not all forensic laboratories follow E2329, and one of 

the references cited in E2548 discusses qualitative testing to identify a substance that would not 

meet E2329 requirements, but still go on to discuss making an inference to the population 

regarding the probability of the population containing that substance. This clause of the standard 

is necessary to ensure laboratories following only E2548 do test any units selected via the sampling 

plan according to E2329 prior to making an inference to the population regarding the probability 

of the population containing a substance identified in the selected samples. 

13. FIG. 1. Relationship of Various Levels Required in Sampling

a. Previously, the leaves in the top “statistical” branch were "Hypergeometric," "Bayesian," 

and "Other probability-based approaches." These have been trimmed to “Bayesian” and 

“Frequentist.” This is an improvement, since “Hypergeometric” is merely the name of a 

probability distribution, and not a form of sampling. (When sampling without 

replacement, the probability that a number X of units with a discrete feature will be 

picked in N draws follows the hypergeometric distribution. This is true for Bayesians and

frequentists alike.) 

Subcommittee Response: Agreed; this improvement is one of the reasons we feel it is 

important to replace the superseded E2548-11e1 document with the E2548-16 version on 

the Registry.

b. The problem that remains in this branch is that neither “Bayesian” nor “frequentist” 

describes a sampling plan. For example, the results for a simple random sample (SRS) can 

be analyzed from either perspective, and the sample size can be pre-established 

according to computations with either methodology (or via likelihood computations, for 

that matter). Presumably, a sampling procedure that implements the SRS design would 

be a “sampling plan.” But the SRS design itself is neither Bayesian nor frequentist. In 

addition, there is a third school of statistical thought, likelihood theory, that could be used 

in analyzing sample data.

Subcommittee Response: Persuasive. We recognize that terminology and the distinction 

between sample selection and sampling is a fundamental issue within the standard that 
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we agree needs to be addressed. We understand that the terms “statistical and nonstatistical sampling” may be unclear to some readers and may be interpreted differently 

by various disciplines. To that end, a work item has been opened at ASTM (WK75229) and 

the OSAC Seized Drugs Subcommittee will form a task group to revise the document. The 

challenge faced is that the process of revising the standard through the OSAC and ASTM 

processes will take 3+ years and we feel the addition of the compulsory language 

regarding random sampling is an important enough change to support replacement of 

E2548-11e1 with E2548-16 on the Registry.

c. The leaves of the “Non-Statistical” branch are “Square Root N,” “Management Directive,” 

and “Judicial Requirements.” The first leaf refers to a procedure for establishing the size 

of a sample. The square root of N assuredly is a statistic, and unless the population size 

exceeds 9, the method is to draw an SRS (see United Nations Office on Drugs and Crime, 

Recommended Methods for Testing Opium, Morphine and Heroin: Manual for Use by 

National Drug Testing Laboratories, p.21). Consequently, the “square root method” can 

be used to obtain a sample statistic that is a statistically sound estimator of a population 

parameter.

Subcommittee Response: Persuasive. We recognize that terminology and the distinction 

between sample selection and sampling is a fundamental issue within the standard that 

we agree needs to be addressed. We understand that the terms “statistical and nonstatistical sampling” may be unclear to some readers and may be interpreted differently 

by various disciplines. To that end, a work item has been opened at ASTM (WK75229) and 

the OSAC Seized Drugs Subcommittee will form a task group to revise the document. The 

challenge faced is that the process of revising the standard through the OSAC and ASTM 

processes will take 3+ years and we feel the addition of the compulsory language 

regarding random sampling is an important enough change to support replacement of 

E2548-11e1 with E2548-16 on the Registry.

d. The next two leaves can apply to any choice of a sampling design that comes from a 

manager or a court. The design could be statistically optimal or wasteful, but its statistical 

properties do not make it “non-statistical.” Perhaps the branch is supposed to be “not 

suitable for statistical inference,” but that does not lead to the three leaves either.

Subcommittee Response: Persuasive. We recognize that terminology and the distinction 

between sample selection and sampling is a fundamental issue within the standard that 

we agree needs to be addressed. We understand that the terms “statistical and nonstatistical sampling” may be unclear to some readers and may be interpreted differently 

by various disciplines. To that end, a work item has been opened at ASTM (WK75229) and 

the OSAC Seized Drugs Subcommittee will form a task group to revise the document. The 

challenge faced is that the process of revising the standard through the OSAC and ASTM 

processes will take 3+ years and we feel the addition of the compulsory language 

regarding random sampling is an important enough change to support replacement of 

E2548-11e1 with E2548-16 on the Registry.

e. In sum, Figure 1 muddies the waters. It should be abandoned or redrawn after more 

appropriate and better defined terminology is in place.
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Subcommittee Response: Persuasive. We recognize that terminology and the distinction 

between sample selection and sampling is a fundamental issue within the standard that 

we agree needs to be addressed. We understand that the terms “statistical and nonstatistical sampling” may be unclear to some readers and may be interpreted differently 

by various disciplines. To that end, a work item has been opened at ASTM (WK75229) and 

the OSAC Seized Drugs Subcommittee will form a task group to revise the document. The 

challenge faced is that the process of revising the standard through the OSAC and ASTM 

processes will take 3+ years and we feel the addition of the compulsory language 

regarding random sampling is an important enough change to support replacement of 

E2548-11e1 with E2548-16 on the Registry.

14. “5.2.1 The population determination shall take into account all typical forms and quantities in 

which exhibits may appear.”

a. What is an “exhibit”? The term appears nowhere else in the Guide. 

Subcommittee Response: Editorial - does not critically impact the interpretation of the 

standard. This term is commonly used within seized drugs forensic laboratories, however, 

it should be defined in this standard. A terminology section of terms specific to the 

standard would be beneficial and strengthen the standard; the planned revisions to the 

standard will incorporate a terminology section.

b. Why should atypical forms and quantities (of what?) not be considered along with typical 

ones?

Subcommittee Response: Editorial - does not critically impact the interpretation of the 

standard. 

15. “5.2.2 A population can consist of a single unit or multiple units.

5.2.3 A multiple unit population shall consist of items that are similar in relevant visual 

characteristics (for example, size, color, shape, etc.).”

The wording suggests that material packaged in containers of different sizes or color is not a 

population of legal interest. In this form, the material is neither a “single unit” nor a “multiple 

unit” population. The statistical question may concern a feature of all the material, and that 

collection would be the population. It appears that in this standard, a “population” is a sampling 

frame that is constructed from the population. The literature on attribute and variable sampling 

as well as multistage sampling should be consulted. In sampling theory, a “sampling unit” is not 

necessarily a single element of the population. There are smaller units of elements at each stage.

Subcommittee Response: Persuasive, although the change is not critical to the use of the standard 

as written. Typically units that are similar in relevant visual characteristics would be grouped 

together into subpopulations for sampling in seized drugs. We recognize that this step may not be 

clear based on the current wording in the standard. To that end, a work item has been opened at 

ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will form a task group to revise the 

document. The challenge faced is that the process of revising the standard through the OSAC and 

ASTM processes will take 3+ years and we feel the addition of the compulsory language regarding 

random sampling is an important enough change to support replacement of E2548-11e1 with 

E2548-16 on the Registry.
Page 10 of 20

16. “5.4 When a single unit or bulk population is to be analyzed, the issue of homogeneity shall be 

addressed within the sampling plan.”

Now it appears that there is a third kind of population—a “bulk population” that is neither a single 

unit nor a combination of units. The definitions of all these populations should be in a definitions 

section.

Subcommittee Response: Editorial. These terms are used within seized drugs forensic laboratories, 

however they should be defined to explain how they apply to this standard. A terminology section 

of terms specific to the standard would be beneficial and strengthen the standard; the planned 

revisions to the standard will incorporate a terminology section.

17. “5.4.1 One sample is sufficient if the bulk material is homogeneous. Analysts can make bulk 

material homogeneous.”

Normally, a sample is the subset of elements drawn from the sampling frame that represents the 

population of interest. Of course, “sample” has another meaning—a single chunk of material for 

instrumental or visual analysis—but that is not necessarily a “sample” as the term is used in 

sampling theory. The sample from the population can consist of many items. Substituting 

“specimen” for “sample” in this section would avoid possible confusion.

Subcommittee Response: Editorial - does not critically impact the interpretation of the standard. 

We recognize the terminology is an issue within the standard that we agree needs to be addressed. 

To that end, a work item has been opened at ASTM (WK75229) and the OSAC Seized Drugs 

Subcommittee will form a task group to revise the document. The challenge faced is that the 

process of revising the standard through the OSAC and ASTM processes will take 3+ years and we 

feel the addition of the compulsory language regarding random sampling is an important enough 

change to support replacement of E2548-11e1 with E2548-16 on the Registry.he term

18. “5.5 For a multiple unit population, the sampling plan may be statistical or non-statistical.”

See supra comment on Figure 1.

Subcommittee Response: Persuasive. We recognize the terminology and the distinction between 

sample selection and sampling is a fundamental issue within the standard that we agree needs to 

be addressed. We understand that the terms “statistical and non-statistical sampling” may be 

unclear to some readers and may be interpreted differently by various disciplines. To that end, a 

work item has been opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will 

form a task group to revise the document. The challenge faced is that the process of revising the 

standard through the OSAC and ASTM processes will take 3+ years and we feel the addition of the 

compulsory language regarding random sampling is an important enough change to support 

replacement of E2548-11e1 with E2548-16 on the Registry.

19. “5.5.1 Statistical approaches are applicable when inferences are made about the whole 

population. For example:

The probability that a given percentage of the population contains the drug of interest or is 

positive for a given characteristic.

The total net weight of the population is to be extrapolated from the weight of a sample.”
Page 11 of 20

a. Normally one would speak of the population percentage as a parameter whose value is 

being estimated from sample data. The estimate is an inference. A hypothesis about the 

true value would be another inferential statement. The “probability that a given 

percentage of the population contains the drug of interest or is positive for a given 

characteristic,” if based on the sample data and a prior distribution, would be called a 

posterior probability for the inference. The posterior probability cannot be computed 

with frequentist methods for inference, and this fact should be made clear in the Standard 

Guide (and included in reports that contain coverage probabilities). 

Subcommittee Response: Persuasive. However, this particular ASTM standard is a 

standard guide. Per ASTM requirements, guides are a compendium of information or 

series of options that do not recommend a specific course of action. We do agree that the 

standard could be improved and provide additional guidance to the reader and the goal 

of the planned revisions to the standard will be to change the standard from a guide into 

a practice to provide additional information. 

b. The second example is not the inference; it is the objective of the study. An example of 

an inference would be “Extrapolating from the sample data, the total net weight of a 

controlled substance in the population is 500 grams.”

Subcommittee Response: Editorial - does not critically impact the interpretation of the 

standard.

20. “5.5.1.1 Published examples of statistical approaches involving general considerations:

(1) Practice E105.

(2) Practice E141.

(3) Terminology E1732.”

A glossary or dictionary of terms is not an example of an approach.

Subcommittee Response: Editorial - does not critically impact the interpretation of the standard.

21. (4) Guidelines on Representative Drug Sampling.4

4 2009 UNODC/ENFSI Guidelines on Representative Drug Sampling, European Network of Forensic 

Science Institutes (ENFSI), 2004, http://www.ENFSI.org.

A 2009 document cannot be published in 2004.

Subcommittee Response: Editorial - does not critically impact the interpretation of the standard.

22. (5) ISO 3534-1.

(6) ISO 3534-2.

A glossary or dictionary of terms is not an example of an approach, but maybe some of the 

definitions contain such examples.

Subcommittee Response: Editorial - does not critically impact the interpretation of the standard.

23. “5.5.2 Non-statistical approaches are appropriate if no inference is to be made about the whole 

population.
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5.5.2.1 Published examples:

(1) The “square root method.”7

(2) Methods listed in “Arbitrary Sampling” in Guidelines on Representative Drug Sampling.”

The “square root method” of (1) is a form of “arbitrary sampling” according to the Guidelines cited 

in (2). Therefore, having the two categories of “non-statistical approaches” makes little sense 

(even if one can construe using an SRS with the various “square root methods” listed in the EU 

document for choosing the sample size as “non-statistical”).

Subcommittee Response: Persuasive. We recognize the terminology and the distinction between 

sample selection and sampling is a fundamental issue within the standard that we agree needs to 

be addressed. We understand that the terms “statistical and non-statistical sampling” may be 

unclear to some readers and may be interpreted differently by various disciplines. To that end, a 

work item has been opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will 

form a task group to revise the document. The challenge faced is that the process of revising the 

standard through the OSAC and ASTM processes will take 3+ years and we feel the addition of the 

compulsory language regarding random sampling is an important enough change to support 

replacement of E2548-11e1 with E2548-16 on the Registry.

24. “5.5.2.3 A non-statistical sampling approach may allow an inference about the population. If a 

single population has been randomly sampled, the data may allow an inference to be drawn by 

(1) determining and reporting a confidence interval for an inferred population parameter (for 

example: weight or tablet count); or by (2) retrospectively using the results in a statistical model 

and determining the resulting probabilities and level of confidence.”

This paragraph is a real puzzler. The essence of probability sampling is that the probability that 

each and every element in the sampling frame is known. Knowing these probabilities allows one 

to use a statistical model to determine the sampling distribution of the estimator. That, in turn, 

leads to a standard error, a point estimate, and thus a confidence interval. If “non-statistical 

sampling” does not use probability sampling, how is one supposed to determine the standard 

error? The answer might be to analogize the approach actually used to a probability sampling 

method of some sort. But that interpretation of the paragraph is contradicted by “(2) 

retrospectively using the results in a statistical model and determining the resulting probabilities 

and level of confidence.” (1) is already retrospective and uses a statistical model to produce the

confidence interval, so what is (2) supposed to add? Furthermore, (2) is obscure at best. A “level 

of confidence” is a coverage probability. As such, what are “the resulting probabilities”?

Subcommittee Response: Persuasive. We recognize the terminology and the distinction between 

sample selection and sampling is a fundamental issue within the standard that we agree needs to 

be addressed. We understand that the terms “statistical and non-statistical sampling” may be 

unclear to some readers and may be interpreted differently by various disciplines. To that end, a 

work item has been opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will 

form a task group to revise the document. The challenge faced is that the process of revising the 

standard through the OSAC and ASTM processes will take 3+ years and we feel the addition of the 

compulsory language regarding random sampling is an important enough change to support 

replacement of E2548-11e1 with E2548-16 on the Registry.
Page 13 of 20

25. “5.6.1 Establish the procedure for selecting the number of units that will comprise a sample.”

This sounds prescriptive, but the relative merits of different procedures have, strangely, not been 

discussed in this Standard Guide. Accordingly, the document supplies no guidance beyond a 

general admonition to read the literature mentioned in it and to do the right thing. What would 

that be? The UN report, for example, contends that even though the square-root sample-size 

determination lacks a sound theoretical foundation, it gives reliable results. The EU report, which 

describes this rule-of-thumb as “arbitrary,” acknowledges that it does “work well in many 

situations,” and explicates a number of variations on it. But statisticians have been known to 

dismiss it out of hand. E.g., Alan Julian Izenman, Statistical and Legal Aspects of the Forensic Study 

of Illicit Drugs, 16 Stat. Sci. 35–57, 47 (2001) (“The popularity of the square root rule, despite the 

lack of theoretical support for this rule, shows how an unfounded rule-of-thumb can be 

established in the practice of a particular field.”). What guidance does the Standard Guide have 

to offer?

Subcommittee Response: Not persuasive as to this version, but will be considered as part of the 

full revision of the standard. This particular ASTM standard is a standard guide. Per ASTM 

requirements, guides are a compendium of information or series of options that do not 

recommend a specific course of action. We do agree that the standard could be improved and 

provide additional guidance to the reader and the goal of the planned revisions to the standard 

will be to change the standard from a guide into a practice to provide additional information. 

26. “5.6.1.1 For non-statistical approaches, select a sample appropriate for the analytical objectives.”

There is no indication in the Standard Guide of how to go about doing this and no clear statement 

of what “analytical objectives” are. Usually, “analysis” in the Standard Guide refers to laboratory 

analysis (particularly § 6), but in this subsection the phrase “analytical objectives” seems to be a 

veiled reference to doing what management or the law dictates. Or, if that is not what the words 

point to, does not the same advice apply to “statistical approaches”? Surely, in all situations, one 

should select “a sample appropriate for the analytical objectives.” The reader is left uninformed 

by the Guide.

Subcommittee Response: Not persuasive as to this version, but will be considered as part of the 

full revision of the standard. This particular ASTM standard is a standard guide. Per ASTM 

requirements, guides are a compendium of information or series of options that do not 

recommend a specific course of action. We do agree that the standard could be improved and 

provide additional guidance to the reader and the goal of the planned revisions to the standard 

will be to change the standard from a guide into a practice to provide additional information.

27. “5.6.1.2 For statistical approaches, random sampling shall be conducted.”

Given that probability sampling always is possible in this context (at least approximately), why 

would one ever want anything less? For example, if the sample size n is determined by the formula 

n = N/10, where N is the population size (based on an opinion in which some judge at some time 

said that he or she thought that samples of less than 10% could not be trusted), are we in the 

5.6.1.1 realm of “non-statistical approaches”? The selection method should use a randomizing 

mechanism regardless of a “non-statistical” approach to determining the sample size.
Page 14 of 20

Subcommittee Response: Not persuasive as to this version, but will be considered as part of the 

full revision of the standard. Sample selection up to a weight threshold may not require random 

selection since no inference to the population is made. We recognize the terminology and the 

distinction between sample selection and sampling is a fundamental issue within the standard 

that we agree needs to be addressed. We understand that the terms “statistical and non-statistical 

sampling” may be unclear to some readers and may be interpreted differently by various 

disciplines. To that end, a work item has been opened at ASTM (WK75229) and the OSAC Seized 

Drugs Subcommittee will form a task group to revise the document. The challenge faced is that 

the process of revising the standard through the OSAC and ASTM processes will take 3+ years and 

we feel the addition of the compulsory language regarding random sampling is an important 

enough change to support replacement of E2548-11e1 with E2548-16 on the Registry.

28. “5.6.2.1 A random sample is one selected without bias and where each item has an equal chance 

of being selected.”

The words “without bias” seem like they represent a separate requirement, but they are merely 

superfluous. The reason to give an item in a sampling unit (which could be the sampling frame) 

an equal probability of being selected is to avoid bias (and give estimates of sampling error a solid 

foundation). The sentence could be broken into the three different thoughts: “A simple random 

sample is one in which each item in the sampling frame has an equal probability of being selected. 

Using a randomizing procedure to equalize the probability avoids selection bias and supplies the 

foundation for estimating sampling error.”

Subcommittee Response: Editorial - does not critically impact the interpretation of the standard. 

29. Why is simple random sampling the only acceptable form of probability sampling?

Subcommittee Response: Not persuasive as to this version, but will be considered as part of the 

full revision of the standard. There is no negative impact to the standard by only discussing random 

sampling. The addition of other forms of probability sampling may be considered during the next 

revision to the standard.

30. “5.6.2.1 Computer generated random numbers or random number tables are commonly 

employed for such tasks and these should be included in the sampling plan.

5.6.2.2 Random sampling of items using random number tables may not be practical in all cases. 

In these instances, an alternate sampling plan shall be designed and documented to approach 

random selection. A practical solution involves a “black box” method, which refers to one that will 

prevent the sampler from consciously selecting a specific item from the population (that is, all 

units are placed in a box and the samples for testing are selected without bias).”

5.6.2.1 requires a sampling plan that provides for selection according to random numbers even 

when their use is impractical. Then 5.6.2.2 says not to use that part of the plan in some cases. The 

final clause of 5.6.2.1 should be “and these should be part of the sampling plan unless a statement 

showing that they are impractical is included in the written plan.”
Page 15 of 20

Subcommittee Response: Not persuasive. 5.6.2.1 states that random number generators should 

be used, they are not required. 5.6.2.2 provides guidance on what to do when a random number 

generator is not able to be used.

31. Why are “random number tables” but not pseudo-random number generators the subject of 

5.6.2.2?

Subcommittee Response: Not persuasive. There is no negative impact to the standard by only 

discussing random number tables. The addition of other forms of random number generators may 

be considered during the next revision to the standard.

32. “5.7 Sample Reduction—Sample reduction may be applied in cases where the weight or volume 

of the selected units is too large for laboratory analysis (Fig. 2, insert A).”

“Sample reduction” should be defined. Figure 2 does it to some extent (by listing the names of 

three methods for reducing the quantity), but a section with a general definition would improve 

readability. Again, in the figure, “sample” is used in the laboratory-analysis sense rather than the 

sampling-from-a-population sense. A word or phrase like “specimen” or “analytical unit” would 

be better for the former kind of sample.

Subcommittee Response: Editorial - does not critically impact the interpretation of the standard. 

This term is commonly used within seized drugs forensic laboratories, however, it should be 

defined in this standard. A terminology section of terms specific to the standard would be 

beneficial and strengthen the standard; the planned revisions to the standard will incorporate a 

terminology section.

33. “6. Analysis 

6.1 Statistically Selected Sample(s)—In accordance with 4.2.2, it is recommended that each unit 

comprising the sample be analyzed to meet Practice E2329 if statistical inferences are to be made 

about the whole population.

6.2 Non-statistically Selected Sample(s)—Practice E2329 shall be applied to at least one unit of 

the sample.”

See comment on § 4.2.2.

Subcommittee Response: Previously considered in reference to 4.2.2.

34. “7. Documentation

7.1 Inferences drawn from the application of the sampling plan and subsequent analyses shall be 

documented.”

This section is exceedingly skimpy. It does not even cover the documentation mentioned in § 

4.2.1.2 and § 5.6.2.2

Subcommittee Response: Persuasive. Sections 4.2.1.2 and 5.6.2.2 do provide some additional 

requirements on documentation and reporting and there are separate ASTM reporting standards. 

However, we agree that this section should be expanded. To that end, a work item has been 

opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will form a task group to 

revise the document. The challenge faced is that the process of revising the standard through the 
Page 16 of 20

OSAC and ASTM processes will take 3+ years and we feel the addition of the compulsory language 

regarding random sampling is an important enough change to support replacement of E2548-

11e1 with E2548-16 on the Registry.

35. “8. Reporting

8.1 Sampling information shall be included in reports.”

What “sampling information” should be reported? The subsections that follow (8.1.1 and 8.1.2) 

refer to nothing more than a statement of the results. They do not discuss reporting the parts of 

the sample design and selection mechanisms that led to the testing.

Subcommittee Response: Persuasive. Sections 4.2.1.2 and 5.6.2.2 do provide some additional 

requirements on documentation and reporting and there are separate ASTM reporting standards. 

However, we agree that this section should be expanded. To that end, a work item has been 

opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will form a task group to 

revise the document. The challenge faced is that the process of revising the standard through the 

OSAC and ASTM processes will take 3+ years and we feel the addition of the compulsory language 

regarding random sampling is an important enough change to support replacement of E2548-

11e1 with E2548-16 on the Registry.

36. “8.1.1 Statistically Selected Sample(s)—Reporting statistical inferences for a population is 

acceptable when testing is performed on the statistically selected units as stated in 6.1 above. 

The language in the report must make it clear to the reader that the results are based on a 

probability-based sampling plan. 8.1.2 Non-Statistically Selected Sample(s)—The language in the 

report must make it clear to the reader that the results apply to only the tested units. For example, 

2 of 100 bags were analyzed and found to contain Cocaine.”

a. The Guide is confusing in its description of what qualifies as “a probability-based sampling 

plan.” For example, it appears from Figure 1 and parts of the text noted above that if the 

sample size is not chosen by using probability theory at that stage, the result is a “nonstatistically selected sample.” The report therefore could not make any extrapolation to 

the population from an SRS with an ad hoc sample size. But using an unnecessarily large 

sample—which is what using a statistically optimal sample size guards against—does not 

undermine the validity of a statistical inference from the SRS. The laboratory should be 

able to make inferences from probability samples regardless of the method for choosing 

the sample size.

Subcommittee Response: Persuasive. We recognize the terminology and the distinction 

between sample selection and sampling is a fundamental issue within the standard that 

we agree needs to be addressed. We understand that the terms “statistical and nonstatistical sampling” may be unclear to some readers and may be interpreted differently 

by various disciplines. To that end, a work item has been opened at ASTM (WK75229) and 

the OSAC Seized Drugs Subcommittee will form a task group to revise the document. The 

challenge faced is that the process of revising the standard through the OSAC and ASTM 

processes will take 3+ years and we feel the addition of the compulsory language 

regarding random sampling is an important enough change to support replacement of 

E2548-11e1 with E2548-16 on the Registry.
Page 17 of 20

b. When the sample is not a probability sample—one drawn so as to give every element in 

the sampling frame a known probability of selection—an ampliative inference is of 

questionable validity, and the demand that the report “make it clear to the reader that 

the results apply to only the tested units” is reasonable. But merely stating that x out of 

N bags “were analyzed and found to contain Cocaine” does not make it clear that the 

sample proportion x/N might deviate greatly from the population proportion and that, 

without simple random sampling, statistical theory cannot be used to estimate the 

sampling error. Moreover, although the “x of N” format for reporting is just as appropriate 

for estimates from probability samples, § 8.1.1 does not mention it. It only addresses the 

need to report that “a probability-based sampling plan” was used. It overlooks the issue 

of how to report the results themselves.

Subcommittee Response: Persuasive. While there are separate ASTM reporting standards, 

we agree that this section should be expanded. To that end, a work item has been opened 

at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will form a task group to 

revise the document. The challenge faced is that the process of revising the standard 

through the OSAC and ASTM processes will take 3+ years and we feel the addition of the 

compulsory language regarding random sampling is an important enough change to 

support replacement of E2548-11e1 with E2548-16 on the Registry.

37. “9. Keywords

9.1 analytical method; qualitative method; quantitative method; sampling; seized drug analytical 

method”

The only keyword that has to do with sampling is “sampling.” For a Standard Guide on sampling, 

that is shocking.

Subcommittee Response: Editorial - does not critically impact the interpretation of the standard.

Commenter 2:

E2548 Standard Guide for Sampling Seized Drugs for Qualitative and Quantitative Legal Task Group 

Comments. The primary role of the Legal Task Group is to review standards with an eye towards how the 

standards will be used in the legal system. Sections of standards addressing documentation, reporting, 

and testimony are therefore of great concern to this task group. For the reasons set forth in these 

comments, we do not believe this standard belongs in the Registry. 

1. Inadequate reporting which allows for testimony that overstates the conclusions reached by the 

analyst has been one of the leading causes of wrongful convictions in the area of forensic science. 

It is essential that consensus standards advise laboratories to establish protocols that require 

analysts to clearly and fully document files so that another analyst examining the file may see 

precisely what the analyst did and how she came to her conclusion. Reports should be similarly 

detailed so that the end user of the report is apprised of the conclusions, the basis for the 

conclusions and their limitations. The National Commission on Forensic Science expressed the 

view “that Forensic Science Service Providers (FSSPs) and Forensic Medicine Service Providers 
Page 18 of 20

(FMSPs) should have written policies for documenting the examination, testing, or interpretation 

of evidence and for the reporting of results, interpretations, and conclusions that are consistent 

with the following requirements: 

a. Records should be created during the examination of evidence and during the technical 

review that would allow another analyst or scientist with proper training and experience 

to understand and evaluate all the work performed and to independently analyze and 

interpret the data and draw conclusions. 

b. Records created by FSSPs and FMSPs should also provide information necessary for use 

in the criminal justice system (e.g., chain of custody). 

c. Providing all of the documentation described above in a single report in every case is 

impractical. Instead, if not in the report, the documentation described herein must be 

maintained in a case record if it is specific to a c///se or test. Generic documentation such 

as standard operating procedures and definitions must either be a part of the case record 

or be easily accessible (e.g., posted on a web site, made available on request). 

d. Reports should accurately and clearly convey a statement of the purpose of the 

examination, testing, and interpretation of the evidence; the method and materials used; 

a summary or a description of the data or results obtained; any conclusions or 

interpretations derived from the data or results; any discordant results, interpretations, 

or conclusions; and, where necessary for the interpretation of test results, sources of 

uncertainty in the procedure and conclusions along with estimates of their scale. 

e. Every report should include a statement that the report does not contain all of the 

documentation associated with the work performed or what is necessary to understand 

and evaluate all the work performed, and to independently analyze and interpret the data 

and draw conclusions requires a review of the case record. The case record should be 

organized; and made available in a manner consistent with the discovery 

Recommendations of the National Commission on Forensic Science.” 

E2548 fails to give adequate guidance regarding what must be documented and reported and 

thus fails to provide labs the guidance the criminal justice system requires. 

Subcommittee Response: Persuasive. While there are separate ASTM reporting standards, we 

agree that this section should be expanded. To that end, a work item has been opened at ASTM 

(WK75229) and the OSAC Seized Drugs Subcommittee will form a task group to revise the 

document. The challenge faced is that the process of revising the standard through the OSAC and 

ASTM processes will take 3+ years and we feel the addition of the compulsory language regarding 

random sampling is an important enough change to support replacement of E2548-11e1 with 

E2548-16 on the Registry.

2. “7. Documentation 7.1 Inferences drawn from the application of a sampling plan and subsequent 

analysis shall be documented.” 

This section (or some other) must specify the essential elements of the sampling plan that are 

subject to this documentation requirement. Plainly, it is not sufficient to document only the 
Page 19 of 20

inferences. The meaning of “subsequent analysis” is obscure. Is it the tests used to identify or 

quantify the seized material? A confidence interval or some other statistic that indicates sampling 

uncertainty? Something else? 

Subcommittee Response: Persuasive. We agree that this section should be expanded. To that end, 

a work item has been opened at ASTM (WK75229) and the OSAC Seized Drugs Subcommittee will 

form a task group to revise the document. The challenge faced is that the process of revising the 

standard through the OSAC and ASTM processes will take 3+ years and we feel the addition of the 

compulsory language regarding random sampling is an important enough change to support 

replacement of E2548-11e1 with E2548-16 on the Registry.

3. “8. Reporting 8.1 Sampling information shall be included in a report.” 

Neither section provides the requisite level of specificity. As written, the standard does not 

require labs to provide legally sufficient documentation or reporting. At a minimum the sampling 

plan and how it was chosen should be documented. The limits of the plan that was used should 

be clearly reported. An analyst reviewing the file should know precisely what plan was used, why 

it was selected and the limits of the conclusion reached given the plan chosen.

Subcommittee Response: Persuasive. While there are separate ASTM reporting standards, we 

agree that this section should be expanded. To that end, a work item has been opened at ASTM 

(WK75229) and the OSAC Seized Drugs Subcommittee will form a task group to revise the 

document. The challenge faced is that the process of revising the standard through the OSAC and 

ASTM processes will take 3+ years and we feel the addition of the compulsory language regarding 

random sampling is an important enough change to support replacement of E2548-11e1 with 

E2548-16 on the Registry.

4. Section 8.1.1 states that “The language in the report must make it clear to the reader that the 

results are based on a probability-based sampling Plan.” To say that sampling involved some 

unspecified randomizing mechanism (which is what we presume “probability-based” means) is 

grossly incomplete. The report should state which sampling plan was actually used. If the sampling 

as performed deviated from the plan adopted in advance, that should be stated and justified. The 

report should state the sampling error or include some other measure of uncertainty arising from 

sampling — as well as from other sources. In short, the standard is missing any reasonably 

complete statement or explanation of what to include in a report about a sampling plan. 

Subcommittee Response: Persuasive. While there are separate ASTM reporting and uncertainty 

standards, we agree that this section should be expanded and an uncertainty section added. To 

that end, a work item has been opened at ASTM (WK75229) and the OSAC Seized Drugs 

Subcommittee will form a task group to revise the document. The challenge faced is that the 

process of revising the standard through the OSAC and ASTM processes will take 3+ years and we 

feel the addition of the compulsory language regarding random sampling is an important enough 

change to support replacement of E2548-11e1 with E2548-16 on the Registry.
Page 20 of 20

5. Section 8.1.2 states that for “Non-Statistically Selected Sample(s) —The language in the report 

must make it clear to the reader that the results apply to only the tested units. For example, 2 of 

100 bags were analyzed and found to contain Cocaine.” This example does not make it clear “that 

the results apply to only the tested units.” It is simply a statement of the results. Whenever 

sampling is used, such a statement of results should be in the report. The standard is missing any 

reasonably complete explanation of what to include in a report about the limits of what it calls 

“non-statistical sampling.” 

Subcommittee Response: Persuasive. While there are separate ASTM reporting standards, we 

agree that this section should be expanded. To that end, a work item has been opened at ASTM 

(WK75229) and the OSAC Seized Drugs Subcommittee will form a task group to revise the 

document. The challenge faced is that the process of revising the standard through the OSAC and 

ASTM processes will take 3+ years and we feel the addition of the compulsory language regarding 

random sampling is an important enough change to support replacement of E2548-11e1 with 

E2548-16 on the Registry.