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© 2013 AOAC INTERNATIONAL
G
UIDELINES
FOR
D
IETARY
S
UPPLEMENTS
AND
B
OTANICALS
AOAC O
FFICIAL
M
ETHODS
OF
A
NALYSIS
(2013)
Appendix K, p. 16
PART II
AOAC Guidelines for Validation
of Botanical Identification Methods
Contents
1 Scope
2 Applicability
3 Terms and Definitions
3.1 Botanical
3.2 Botanical Identification Method (BIM)
3.3 Candidate Method
3.4 Exclusivity
3.5 Exclusivity Sampling Frame (ESF)
3.6 Exclusivity Panel
3.7 Identity Specification (IS)
3.8 Inclusivity
3.9 Inclusivity Sampling Frame (ISF)
3.10 Inclusivity Panel
3.11 Laboratory Sample
3.12 Nontarget Botanical Material
3.13 Physical Form
3.14 Probability of Identification (POI)
3.15 Sample
3.16 Specified Inferior Test Material (SITM)
3.17 Specified Superior Test Material (SSTM)
3.18 Standard Method Performance Requirements (SMPRs)
3.19 Target Botanical Material
3.20 Test Portion
4 Validation Study Guidelines
4.1 SMPRs
4.2 SLV Study
4.3 Independent Validation Study
4.4 Collaborative Study
Annex A: Candidate Method (or Prevalidation Study)
Annex B: Understanding the POI Model
Annex C: Number of Test Portions
1 Scope
The purpose of this document is to provide comprehensive
technical guidance for conducting AOAC INTERNATIONAL
(AOAC) validation studies for botanical identification methods
submitted for AOAC
Official Methods of Analysis
SM
(OMA)
status and/or for
Performance Tested Methods
SM
(PTM) status.
The requirements for single-laboratory validation (SLV) studies,
independent validation studies, and collaborative validation studies
for those methods are described.
2 Applicability
These guidelines are intended to be applicable to the validation of
all candidate botanical identification methods (
Annex A
) submitted to
AOAC for (
1
) OMA status through either a collaborative study or an
alternative pathway study or (
2
) PTM certification.
3 Terms and Definitions
3.1 Botanical
Of, or relating to, plants or botany. May also include algae and
fungi. May refer to the whole plant, a part of the plant (e.g., bark,
woods, leaves, stems, roots, rhizomes, flowers, fruits, seeds, etc.), or
an extract of the parts.
3.2 Botanical Identification Method (BIM)
A method that establishes identity specifications for a botanical
material and determines, within a specified statistical limit, a binary
test result: YES, the test material is a true example of the target
botanical material and meets the identity specifications, or NO, it
is not the target botanical. Thus, a BIM answers the question, “Is
the test material the same as the target material?” not “What is
this material?” In most cases, the method will achieve this goal by
comparison of the test material with materials from the inclusivity
panel and will return a YES/NO (or, in some cases, a consistent/
nonconsistent) answer.
3.3 Candidate Method
The method to be validated or submitted for validation (
Annex A
).
3.4 Exclusivity
Ability of a BIM to correctly reject nontarget botanical materials.
3.5 Exclusivity Sampling Frame (ESF)
A list of practically obtainable nontarget botanical materials that
have taxonomic, physical, or chemical composition characteristics
similar to the target botanical and must give a negative result when
tested by the BIM.
This document provides technical protocol guidelines for
the AOAC validation of botanical identification methods and/or
procedures, and covers terms and their definitions associated
with the
Performance Tested Methods
SM
and
Official Methods of
Analysis
SM
programs.
The guidelines working group consisted of James Harnly
(Chair, USDA, ARS), Wendy Applequist (Missouri Botanical
Garden), Paula Brown (British Columbia Institute of Technology),
Steven Caspar (FDA/CFSAN), Peter Harrington (Ohio University),
Danica Harbaugh-Reynaud (AuthenTechnologies, LLC), Norma
Hill (Alcohol and Tobacco Tax and Trade Bureau Compliance
Laboratory), Robert LaBudde (Least Cost Formulations and Old
Dominion University), James Neal-Kababick (Flora Research
Laboratories), Mark Roman (Tampa Bay Analytical Research),
Shauna Roman (Schiff Nutrition International, Inc.), Darryl Sullivan
(Covance Laboratories), Barry Titlow (Compound Solutions), and
Paul Wehling (General Mills/Medallion Laboratories).
The guidelines were approved by the AOAC Official Methods
Board on October 13, 2011.
This work was funded by the National Institutes of Health, Office
of Dietary Supplements.
Reference:
J. AOAC Int
.
95
, 268–272(2012); DOI: 10.5740/
jaoacint.11-447