If Product Testing Revisions to FSMA Preventive Controls Rules Will Affect You, Speak Up

On September 19, in response to comments on its earlier proposed rules, the FDA updated the revised FSMA Preventive Controls rules and opened up another 75-day round of public comment. The deadlines for when the final rules will be published remain the same: Aug. 30, 2015, for preventive controls for human food and for animal food.

Will these revisions affect your operation? The revisions in general are generally what was expected and are consistent with what the FDA said it would change. But there are some exceptions. One of the most notable is the proposed revision to the preventive controls rule that would incorporate product testing, environmental monitoring and domestic supplier verification requirements in that final rule.

While this potential rule was mentioned in the preamble of the proposed rule, it was not included in the rules text. Even so, it provoked controversy. Now the FDA is providing an opportunity for input on specific language and seeking comment on whether to include it in the final rule.

The comments would address whether the preventive controls for human food should require a facility, where appropriate, to conduct product testing to verify implementation and effectiveness of preventive controls; to conduct environmental monitoring to verify implementation and effectiveness of preventive controls if an environmental pathogen is a significant hazard; and supplier verification when analysis identifies a significant hazard for a raw material or ingredient and that hazard is controlled before the facility receives the raw material from a supplier.

Significance
While these revisions are generally less burdensome, the product testing and supplier verification rules are likely to provoke negative comments. Each would involve additional cost in the form of new equipment, labor and potentially visits to each supplier to conduct verification.

If you will be one of the companies affected by the changes, now is your chance to comment and express your opinion about the burden versus the efficacy of product testing as a means to ensure food safety.

The FDA pointed out that previous comments had varied on the value of product testing, with some commenters denying its effectiveness as a preventive control, others accepting it and still others accepting product testing but not finished product testing. These varying opinions are why the FDA is opening a new period for further comment with respect to when and how product testing is an appropriate means of implementing FSMA, and whether it should be required by the final rule.

Similarly, in regard to environmental monitoring for potential pathogens, some commented earlier that the rule was too broad and included facilities were occurrence was unlikely, but there was general agreement that such monitoring was a valuable control where appropriate. Now the FDA is asking for comments on potential new requirements under which facilities could tailor their environmental monitoring programs based on risk.

New regulations now proposed affecting supplier verification reply to comments resisting broad application of such regulations to all facilities regardless of potential risk, while recognizing a general agreement that supplier verification is needed.



Written by: Robert Rogers
Senior Advisor for Food Safety and Regulations
METTLER TOLEDO Product Inspection