A Perspective on FDA's Re-proposed FSMA Rules

Editor's Note: The following article is from The Acheson Group. Founder and CEO David Acheson is a member of QA's Advisory Board.

When we wrote about the FSMA re-proposals on September 25, we focused mainly on the proposed changes to the Preventive Controls Rule for Human Food. But in fact, elements of three other rules are also back on the table and open for comment until December 15. We certainly appreciate the red-lined comparison that FDA made available for each of the rules, but has the Agency, in fact, changed its thinking? If so, what impact will this have on the food industry?
First and foremost, we believe the newly issued supplements represent the open rulemaking process at work. Stakeholders provided comment, and FDA listened. Additionally, with respect to the application of preventive controls for animal food, many of the proposed changes mirror those proposed to the human food rule:

• swapping "significant hazard" for one "reasonably likely to occur."
• requirements to conduct environmental monitoring if environmental pathogens are deemed to be significant hazards (FDA notes that animal foods are considered ready to eat).
• the use of finished product testing as appropriate to the food and hazard.
• the need for supplier controls if they are relied upon to control hazards.
• the inclusion of economically motivated adulteration in the mix of hazard identification.

Preventive Controls for Animal Food. But there are some animal-specific changes to the proposed rule, too, primarily surrounding GMPs and the application of the rule to those who divert human food waste or byproducts to animal consumption streams. [Read more]