Records, Compliance and Enforcement Subparts O and P
Food Safety Modernization Act proposed rule
This FDA Proposed Produce Food Safety Rule Q & A conference call, coordinated by the Produce Safety Alliance, discussed recordkeeping, compliance, and enforcement within the impending Food Safety Modernization Act produce rule.
Questions asked during this conference call were:
1. Do lot numbers need to stay the same from supplier to supplier? Currently each supplier assigns its own lot number to a box, can this still occur?
Yes, changing the lot number is OK. Each supplier will need to keep records of what they received and the information that they assigned to each box. There needs to be a way to trace product back and forth one step.
2. Small growers do not want their name and address publicized. How will the traceability rule impact small growers and displaying the farms physical location?
The traceability rule is not yet written, growers are encouraged to comment on how advertising the farms physical location (as a part of the labeling rule affecting both FSMA qualified and non-qualified farms).
3. If the FDA removes the exemption status of a farm how does that farm obtain that exemption status once again?
The FDA will treat this situation on a case by case basis. FSMA includes an appeals process (section 112.204b, 05,06,and 07). Growers who are exempt are not required to keep the records that farms who are not exempt must keep. Should an exempt farm become non-exempt they will be expected to start keeping the required records at that point.
4. What will be expected of farms going through an appeals process?
Growers will want to show any records that they have kept and would want to show the FDA how they have been complying with Good Agricultural Practices and FSMA. Visually showing the FDA investigator your practices is acceptable. Offering the timeframe that records could be produced is also advised.
5. How can variances be used appropriately?
Variances are appropriate for specific regions that have an economic hindrance for compliance. This can apply to individual regions, foreign governments, and states. Alternative methods are very different than variances. Page 3642 section 112.171 details who may request a variance.
6. What are the penalties for growers who should comply but do not?
There are many steps between the FDA coming onto a farm and the act of shutting that farm down. The FDA has the authority of shutting a farm down if they are found to be producing adulterated product. When an FDA inspection takes place there will be the opportunity for a farm to put corrective actions into place. Growers will need to show the investigator what will be done in that corrective action and will have 15 days to reply to the FDA in writing as to the actions put into place.
7. During a National Organic Program inspection the inspector is not permitted to have dialog with the grower about non-compliance. Is this true also for FSMA?
No, the investigator can share information that is available in guidance documents with the grower.
This is the last of the Q&A sessions for the proposed FSMA Produce Rule. For additional questions and answers visit the FDA FSMA Q&A website.