AOAC GFA Stakeholder Program Meeting Book (August 29, 2021)

Method Performance Requirements

Egg

Milk

Peanut

Parameter

Minimum Acceptance criteria for target matrix

Minimum Acceptance criteria for target matrix

Minimum Acceptance criteria for target matrix

Analytical range, ppm LOQ, ppm LOD, ppm

Lower Limit Upper Limit

ч 5 ш 10

Lower Limit Upper Limit

ч 10 ш 20

Lower Limit Upper Limit

ч 10 ш 20

ч 5 ч 5

ч 10 ч 10

ч 10 ч 10

Recovery, % 50-150%

50-150%

50-150%

RSD r , % RSD R , %

чϮϬй чϯϬй

чϮϬй чϯϬй

чϮϬй чϯϬй

ppm whole dried egg

ppmNFDM

ppm peanut

5

5

Method Developer Perspective • Guidance generally lacks specificity • Testing material requirements o What allergen sources are appropriate and how do they need to be characterized? o What are appropriate matrix formulations? o How should incurred foods be processed? • What are expectations for result reporting? • What study designs and results will be accepted by an ERP?

Method User Perspective • Method outputs require too much knowledge and interpretation by end users: o Different results from different methods o Variable units, targets, limits, and performance o Ease of access to method information o Method comparisons challenging • Accuracy and applicability: o What foods/systems can the methods be used with? o How accurate are the results of a given analysis? o Can methods be used to support risk assessment?

Challenges & Gaps with Available Validation Guidance

6

6