During the 2014 Feed and Pet Food Joint Conference, October 7-9 in Omaha, Nebraska, USA, Daniel McChesney, PhD, director of the office of surveillance and compliance for the US Food and Drug Administration’s (FDA) Center for Veterinary Medicine, highlighted key revisions to the preventive control rule for petfood and feed under the Food Safety Modernization Act (FSMA).
McChesney said FDA received more than 2,100 comments to the original proposed animal feed preventive control rule released in October 2013, including many from consumers. Industry organizations, such as the Pet Food Institute and National Grain and Feed Association (co-organizers of the Feed and Pet Food Joint Conference), along with the American Feed Industry Association, also offered in-depth feedback on the original rule.
With the re-proposed rule, which FDA released September 29, 2014, and McChesney referred to as the supplemental proposed rule, the agency is only asking for comments on new or revised areas, though it will accept comments on other areas. FDA is accepting comments for 75 days from the release date.
The major revisions included in the supplemental rule, McChesney said, include:
McChesney commented that in written food safety plans, which FSMA will require of every facility but very small businesses, manufacturers will need to define hazards they are controlling—and how—outside of CGMPs. So, if a facility has comprehensive CGMPs, it might have a very narrowly focused, short safety plan.
With supplier verification, comments to the original proposed rule agreed it's a good idea but didn't like how FDA proposed doing it. So, McChesney said, FDA looked at the foreign supplier verification rule under FSMA and how that might apply to domestic suppliers. In the supplemental proposed rule, FDA is providing flexibility for each facility to determine appropriate verification activities of its suppliers. However, it will likely require an annual audit of significant hazards; unless you're controlling that hazard at your facility, you should verify your supplier is controlling it.
Finally, in response to a question about how FDA inspectors will be trained to enforce FSMA rules, McChesney said that at least initially, inspectors will be looking mainly to see that facilities and their personnel understand the rules and how their company is following them; they would not be looking to write tickets for noncompliance. In other words, initial visits will be focused on education, not compliance.
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