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continued in the pre-collaborative study, where dried eggs, ice cream and peanut butter did

not have the pH adjusted to the proper range.

4. In unpaired studies, it appears that the BAX test was performed from both the

enrichment broth of the reference method and the enrichment broth of the BAX method, as

data is presented for both for the BAX test. For the POD, I would assume the number of

positive from the reference broth that confirmed with the reference method would be

compared to the number of positive from the BAX method broth, that confirmed culturally.

5. Dry pet food, HC method was used as the reference method, yet dry pet food is not in

the scope of application of this method.

6. In the PTM study, processed foods were not inoculated with stressed cells. In the pre-

collaborative study, stressed cells were used to inoculate processed foods, but it was not

stated which matrices were considered processed.

7. In the pre-collaborative study, it was not always clear as whether the BHI regrowth step

(for commodities that required it) was done only for the BAX method, or if it was done for

the reference method as well. If done for the reference method, would this be considered a

deviation from the method?

Reviewer 3 (Hitchins):

The method was awarded PTM status and the pre-collaborative study was presumably

approved before proceeding to this collaborative.

Reviewer 4 (Brodsky):

Pre-collaborative data attests to the breadth of the applicability and addresses all of the

performance

characteristics required.

Reviewer 5 (Hammack):

No comments.

Reviewer 6 (Hayes):

N/A

Reviewer 7 (Fernandez):

Yes. For the following Sample matrixes: Ground Beef, Cream Cheese, Dry Pet Food, Poultry

Rinse, Frozen Peas, Ice Cream, Peanut Butter, Non Fat Dry Milk, Dried Eggs, Lettuce Shell

Eggs, Shrimp, Orange juice, Hot dogs, Environmental, Beef Trim, White Pepper Infant

Formula, ,Ground Beef with Soy, Cocoa, and Ground turkey.

Reviewer 8 (Chen):

There are inconsistencies during the draft and final version of the precollaborative study.

Reviewer 9 (McMahon):

N/A