The FDA Proposed Produce Food Safety Rule Q & A conference call, coordinated by the Produce Safety Alliance, discussed domestic and wild animals. This conference call focused on the potential impact of the rule on production practices regarding animals.
1. The phrase is used “growers will act appropriately” regarding potential contamination from animals on the farm. This phrase is very vague; will there be guidance from the FDA detailing what is “appropriate” action?
We did not want to give concrete metrics because we wanted there to be flexibility within the rule for growers. Currently we have a company contracted to prepare technical data which the FDA will then use to prepare guidance documents.
2. If a grower does not “act appropriately” what will the penalties be? Growers are expected to take all measures reasonably necessary to prevent cross-contamination. Unsanitary conditions are a violation of the act. Section 401-A1 contains pathogen compliance information and section 402-A4 contains information on the course of action should unsanitary conditions be found. Inspectors will not be looking for deer or birds but will be looking for fecal material that is left by them. Will this fecal material come in contact with or be likely to come in contact with the product? Growers should avoid this situation.
3. Will there be an opportunity for input into the governing guidance document?
Yes, we are tracking questions now and this will help inform the rule making and inform the guidance documents. The guidance documents are non-binding and can be easily changed. Comments will always be accepted on the guidance documents.
4. When will these guidance documents become available?
Soon after the final rule is published.
5. Deer droppings are not always evident, how do you monitor large areas of land?
We want to leave it up to your judgment; you should deem what is appropriate.
6. Will thresholds be developed, such as number of pellets per acre acceptable?
No. We do not want to do this; we are looking at the potential for commodity contamination. We suggest that you review commodity specific guidance documents (leafy greens, green onions, fresh culinary herbs, etc.) that are already in existence and apply them to your situation . Obviously if fecal material is observed in direct contact with the produce it should not be harvested.
7. Is product testing required?
No product testing is required.
8. When the guidance document is released will it first come as a draft?
Yes, it will be released as a draft through the federal register.
The next Q&A conference call on May 8th at 11 AM will cover equipment, tools, buildings and sanitation. Health, hygiene and training workers will be discussed on May 10. The recordkeeping, compliance and enforcement call will follow on May 13. Anyone can participate by dialing toll-free 866-906-9888 and entering the passcode: 8140591. These Q&A sessions are recorded and available on the Produce Safety Alliance webpage.
