Hi Ryan,
Thks for above.
I think maybe you missed the thrust of my RA comments. A specific list has been FDA-promised with the (then) proposed RA methodology already drafted. Eons ago.
For Fresh Produce a massive RA using a potentially "similar" technique has been done and the results published (and attached on this forum).
I'm not criticising the delay since I anticipate that any general quantitative approach (not MRA oriented) will be a slog. But this list, as i understood, was intended to be a fundamental crutch for the entire New System. Maybe it's already being quietly "shelved". (Like Brexit ?)
I have somewhat avoided the FSMA topics since my background reading seemed to have concluded that currently, the "learning curve" is a mess and everyone is going to see various oddities come to light as intimated in yr previous post. The extracts attached in this post seemed to crystallise recent progress and their source thread seems to me (a non-USA observer) to contain "cutting-edge" evaluations -
http://www.ifsqn.com...ce/#entry107725
The non-submitting procedure you refer is, I think, identical to that employed by FDA for their seafood haccp pioneering introduction. It tended to mute/divert direct public confrontations. I liked parts of the PCQI manual very much indeed but it also IMO totally avoids some basic nitty-gritty, real-life situations as has been discussed here previously. It also, IIRC, appeared inconsistent with some of the specific RA requirements as defined in the CFR rules. Certain of these divergences have been noted/published and also discussed on this forum. Afaik, no subsequent instructional revisions have been made but i may be out of touch.
Frankly, I am still unsure if this is not all "Much Ado About Nothing" from a purely RA POV.