On September 11, 2015 the FDA released the final rule on the
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food , commonly known as Preventive Controls for Human Foods. Key elements of the final rule are:
The current good manufacturing practices (CGMPs) have been modernized, resulting in an important development that requires specific-food safety training which was formerly only recommended.
The rule emphasizes the importance of hazard analysis and the development of preventive controls to minimize or prevent those hazards from contaminating food.
A written food safety plan is required and must be based upon hazard analysis, development of preventive controls, oversight, monitoring, corrective actions and verification.
The definition of a ‘farm’ has been significantly changed to make it more workable for agricultural businesses and to reflect the current realities of produce production and handling practices. The new definition of ‘farm’ places most, but not all activities that produce businesses routinely engage in at packing establishments under the FSMA Produce Rule and thus significantly reduces the potential for divergent regulatory requirements on similar produce businesses. Significantly, the new definition of ‘farm’ permits growers to pack fresh produce not grown on their farm and remain covered by the FSMA Produce Rule and not the Preventive Controls for Human Foods Rule. The ‘farm’ definition also permits produce holding and packing at off-farm locations to be regulated by the Produce Rule. We will work with federal officials over the next several weeks to provide examples to help guide our members while they determine which rule to follow.
FDA has worked to provide more flexibility for the supply chain and define responsibilities along the supply chain more clearly. The emphasis has been placed on identifying hazards and verifying proper controls prior to receipt.
If you are required to register a food facility with FDA under its existing rules, then you likely will be required by the agency to have a food safety plan. Note that this rule is not limited to produce facilities, it applies to food facilities in general.
It’s anticipated the agency will soon be issuing important companion guidance documents for all final FSMA rules that will provide more detailed information about coverage and compliance requirements. There will be an opportunity to provide comments on these upcoming draft guidance documents, so stay tuned.
Preventive Controls for Human Food Rule Summaries
Keller and Heckman summary of the Final Preventive Controls Rule
FSMA Final Rule Webinars
PMA hosted a webinar series with allied associations, featuring the FDA on the FSMA final rules.
FDA Resources on the Preventive Controls for Human Food Rule
Guidance Documents on Preventive Controls for Human Food
Small Entity Compliance Guide to inform domestic and foreign food facilities about the PCrule and how to complyDRAFT Guidance for Produce Rule, PC for Human Food Rule, PC for Animal Feed Rule, and FSVP Rule for any entity that is subject to certain provisions (in part 117, part 507, the produce safety regulation, or the FSVP regulation) that require a disclosure statement, in documents accompanying food, that certain hazards have not been controlled by that entity.DRAFT Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food DRAFT Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities PMA comments on Hazard Analysis and Risk-Based Preventive Controls for Human Foods: Guidance for Industry
Joint Produce Industry comments on Classification of Activities as Harvesting, Packing, Holding or Manufacturing/Processing for Farms and Facilities; Draft Guidance for Industry
This and all of our food safety-related material is made possible by the members who support PMA's Gold Circle Campaign for Food Safety . Find out how your company can help improve produce food safety throughout the supply chain.
