Session Moderator and Presenter: Deborah McKenzie (AOAC INTERNATIONAL)
Staff Contact: Saliha Argubie ([email protected])
AOAC’s Senior Director of Standards, Deborah McKenzie, provided an overview of general use and need for standards as well as standards development requirements and the AOAC standards development process. Attendees also learned about the development of Standard Method Performance Requirements (SMPRs).
Session Moderator and Presenter: Deborah McKenzie (AOAC INTERNATIONAL)
Staff Contact: Saliha Argubie ([email protected])
AOAC’s Senior Director of Standards, Deborah McKenzie, touched on ethical considerations of participating in an AOAC ERP in the wrap-up to Analytical Methods Week’s kickoff presentation, “AOAC Orientation: ERP – New Methods through Final Action OMA Status.” Attendees learned about adoption of methods, tracking of First Action Official Methods of Analysis and requirements for changing the action status of Official Methods of Analysis.
ERP Co-Chairs: Dr. Kai Zhang (US FDA) and Ms. Egidia Nkezabera (Rwanda Standards Board)
Staff Contact: Saliha Argubie ([email protected])
This new ERP reviewed a modification of AOAC 2001.06, Total Fumonisins in Corn. A validation study report for the method was submitted by Neogen Corporation. The method title, Total Fumonisins in Corn, Final Action 2005 has been modified due to a change in substrate used in the method. The method author made a presentation on the modification. The ERP discussed their reviews and determined that the modification was minor and subsequently approved it.
ERP Chair: Dr. Sean Austin (Société Produits des Nestlé)
Staff Contact: Saliha Argubie ([email protected])
A new single laboratory validation report for LAC-005 was submitted by Metrohm. The method title, Determination of Lactose in Free Lactose and Low Lactose Milk and Milk Products is resubmitted with the ERP recommendations for First Action consideration. The ERP discussed their reviews using AOAC SMPR 2018.009 (SMPR for Lactose in Low-Lactose or Lactose-Free Milk, Milk Products and Products Containing Dairy Ingredients)and the December 2020 ERP report. The ERP delayed adoption of the method pending resubmission of the method manuscript that includes the ERP’s consensus recommendations.
ERP Chair: Dr. Julia Bramante (Colorado Department of Public Health and Environnent)
Staff Contact: Allison Baker ([email protected])
The ERP members reviewed a validation study report for a matrix extension of AOAC 2014.05 to dried cannabis flower, submitted by 3M Food Safety. The proposed matrix extension was titled Enumeration of Yeast and Mold in Dried Cannabis Flower (3M Petrifilm Rapid Yeast and Mold Count Plate) in support of AOAC SMPR 2021.009.
The ERP reviewed the report methods and the matrix extension was approved; AOAC 2014.05 will be revised to support the new applicable matrix of cannabis flour. The published method will be designated as First Action status for this matrix. In accordance with AOAC policy and ERP recommendations, the method will be tracked for a maximum of two years during which demonstrated method reproducibility for the cannabis matrix and user feedback on the method’s performance are among the ERP requirements to recommend the method for Final Action status.
ERP Chair: Dr. Katerina Mastovska (Eurofins US)
Staff Contact: Delia Boyd ([email protected])
The ERP members reviewed a new single laboratory validation study of Chlorate-01 submitted by AsureQuality NZ in support of AOAC SMPR 2021.001 (SMPR for Determination of Chlorate and Perchlorate in Baby Foods, Infant/Adult Formulas and Their Ingredients) for First Action consideration.
The ERP discussed their reviews using the SMPR and the December 2021 ERP report. The ERP delayed adoption of the method pending resubmission of the method manuscript that includes the ERP’s consensus recommendations.
ERP Chair: Lars Reimann (Eurofins US)
Staff Contact: Saliha Argubie ([email protected])
The ERP members reviewed the collaborative study along with ERP requirements and method user feedback for AOAC 2020.07, Available Carbohydrates in Cereal and Cereal Products, Dairy Products, Vegetables, Fruit and Food Products, and Animal Feeds. ERP members also discussed a validation study for a new candidate method for First Action status, entitled Insoluble, Soluble, and Total Dietary Fiber in Foods and Food Ingredients Rapid Integrated Enzymatic-Gravimetric-Liquid Chromatography Method. However, the ERP did not achieve quorum of members; therefore, no action was taken on the method. Both validation studies were submitted by Neogen Corporation (formerly known as Megazyme). Staff will follow up with the ERP members after the meeting.
ERP Chair: Darryl Sullivan (Eurofins US)
Staff Contact: Delia Boyd ([email protected])
The ERP members reviewed a validation study for a candidate fluoride method, Fluor-05 (Determination of Fluoride in Infant Formula by Microdiffusion and Ion Selective Electrode) that was resubmitted by Mérieux NutriSciences. The ERP discussed their reviews using AOAC SMPR 2014.016 (SMPR for Determination of Fluoride in Infant and Adult/Pediatric Nutritional Formula) and the December 2021 ERP report. The ERP delayed adoption of the method pending resubmission of the method validation report that includes the ERP’s consensus recommendations.
The ERP also reviewed a single validation study for a candidate method for Human Milk Oligosaccharides (HMO), HMO-03 (Analysis of 6 Human Milk Oligosaccharides in Infant Formula and Adult Nutritionals by 2AB Labeling and Quantification with HILIC-FLD) that was resubmitted by Eurofins. The ERP discussed their reviews using the following SMPRs for HMOs: 2’FL (AOAC SMPR 2020.003), LNnT (AOAC SMPR 2020.004), 3’SL (AOAC SMPR 2021.003), 3-FL (AOAC SMPR 2021.004), 6’SL (AOAC SMPR 2021.005), DFL (AOAC SMPR 2021.006), and LNT (AOAC SMPR 2021.007). The ERP adopted the method, which will be published as a First Action method.
In accordance with AOAC policy and ERP recommendations, the method will be tracked for a maximum of two years during which demonstrated method reproducibility and user feedback on the method’s performance are among the ERP requirements to recommend the method for Final Action status.
ERP Co-Chairs: Daniele Sohier (Thermo Fisher Scientific) and Catharine Carlin (Mérieux NutriSciences)
Staff Contact: Saliha Argubie, ([email protected])
The ERP reviewed the following methods for matrix extensions or modifications submitted by 3M Food Safety and bioMérieux respectively:
Following deliberation, both AOAC 2015.13 and AOAC 2014.05 were approved to extend their applicability statements to include environmental surfaces. The modification to AOAC 2020.06 was approved to include increased concentrations of primers, probes, enzymes, and PCR buffer and decreased concentrations of MgCl2 in the EH2 assay to reduce internal control inhibitions and improve fluorescent amplitude. The ERP requested follow up regarding criteria for First Action and Final Action status changes for matrix extensions. Additionally, the ERP requested that the method authors include proficiency data as part of the ERP requirements for Final Action status consideration for AOAC 2020.06.
The ERP also approved a reagent color change to the following group of methods submitted by bioMérieux:
