Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

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AOAC RESEARCH INSTITUTE Expert Review Panel Chair Report for Microbiology for Foods and Environmental Surfaces Page 6 of 7

IV.

Discuss Claimed Matrices for AOAC First Action Methods The ERP reviewed, compared and discussed the discrepancies of whether or not additional data is required for AOAC First Action Official Methods 2014.06 and 2014.07, 2013.02 and 2009.03. 2 By consensus the ERP presented the following motions: Motion by Hammack; Second by Fatemi, the ERP recommends the following for collaborative studies: If one matrix is chosen for the collaborative study, it should be the largest sample size used in the single laboratory study with the shortest incubation time. The ERP has the discretion for requesting additional matrices, if deemed necessary. Consensus demonstrated by: 9 in favor, 0 opposed, and 0 abstentions. Motion Passed. Motion by Fernandez; Second by Carter, to modify the applicability statements for AOAC Official Method 2014.06 and AOAC Official Method 2014.07 to include the following: AOAC Official Method 2014.06: Bagged Raw Spinach (25g), whole cantaloupe melon, and plastic (swab at 10 mL) and AOAC Official Method 2014.07: Bagged Raw Spinach (25g), Romaine Lettuce (25g), and whole cantaloupe melon. Consensus demonstrated by: 9 in favor, 0 opposed, and 0 abstentions. Motion Passed. The ERP discussed and reviewed the information received from the method author for the AOAC First Action methods that are or have approached their 2-year tracking period. The method author’s were present to answer questions and comments from the ERP. The ERP is required to make a recommendation on AOAC Official First Action methods, 2 years after adoption, to the AOAC Official Methods Board regarding Final Action status. By consensus of the ERP the following motions were noted. Discuss ISO 16140 Harmonization and Protocol Development ERP members will discuss the potential implementation of Harmonized ISO 16140 Guidelines and the development of harmonized protocols. A summary chart for discussion was provided to the ERP. 3 The ERP previously agreed that for protocol development for collaborative studies: If one matrix is chosen for the collaborative study, it should be the largest sample size used in the single laboratory study with the shortest incubation time. The ERP has the discretion for requesting additional matrices, if deemed necessary. The ERP should also be reminded to select the appropriate sample sizes for the collaborative study protocol during the initial review. The following additional questions were discussed and straw polled by the ERP for consensus. A. Is it possible to consider a reduced number of replicates? AOAC requires 12 and ISO requires 8. i. FDA accepts ISO 16140 with 8 replicates as long as it has an FDA reference method. Deb will follow-up with USDA to see if they have similar acceptance and with the AOAC Statistics Committee regarding use of 8 laboratories instead of 12. ERP Use Only

V. Discuss Final Action Requirements for First Action Official Methods (if applicable)

VI.

2 Attachment 2: Claimed Matrices Comparison Chart 3 Attachment 3: Collaborative Study Matrix Selection Comparison Chart

04/05/2019