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First FSMA Rules Finalized by FDA

Today two key elements of the long-anticipated Food Safety Modernization Act (FSMA) became final. With their publication in the Federal Register, the Rules covering Preventive Controls for Human Food and the Preventive Controls for Foods for Animals are now laws – although actual compliance dates will range from one to three years, depending on the size of the operation.

For many in the leafy greens industry, the Preventive Controls for Human Food rule will be of significant interest. Much of what is in the final rule reflects earlier draft versions: Facilities (not farms – these will be covered under the still-to-be-published Produce Rule) “must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls.” Specific requirements are spelled out in the rule itself.

In the final rule, the FDA has responded to many of the comments provided by industry during the comment period on these rules. Of particular note, many of the definitions for things like a “Farm” or a “Mixed Type Facility” appear to have been improved in the final version of the Preventive Practices rule. Earlier versions had concerned the industry because they didn’t accurately reflect modern farming practices.

We expect these changes in definitions to be consistent in the other rules – particularly the Produce Rule – as they are finalized.

You can learn more about these rules and read the actual regulations on FDA’s FSMA website.

In addition, on September 15th, 16th and 17th FDA will be hosting a series of webinars on these new rules.

Additional FSMA Rules will be published over the coming months.

fsma rules

While we still need to spend some time going through the final rules, we would like to commend the FDA for taking industry feedback into account through the comment process. We believe the agency has worked diligently to create rules that are protective of consumer health and workable for the produce industry.

Stay tuned as we will be reviewing all of the FSMA-related rules and providing our analysis and feedback.


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