On January 04, 2018, the United States Food and Drug Administration (FDA) announced their position on enforcement discretion for certain Food Safety Modernization Act (FSMA) Regulations. Specifically, the FDA intends to exercise enforcement discretion for certain provisions in four of the rules within the FDA Food Safety Modernization Act. This means that during the enforcement discretion period, the agency does not intend to enforce these provisions as they currently apply to certain entities or activities. The enforcement discretion pertains to specific provisions in the Current Good Manufacturing Practices (cGMP), Hazard Analysis and Risk-Based Preventive Controls for Human Food rule (PC Human Food), cGMP, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption rule (Produce Safety) and how they apply to certain facilities. This includes:
The reasoning for this enforcement discretion is to allow time for the FDA to consider changes or other approaches to addressing some of the concerns that have been brought up with regards to the application of these provisions. The FDA had previously extended the compliance dates for many of the provisions covered by this enforcement discretion guidance but is now exercising enforcement discretion, which allows them to make the final decision on who the rulings apply to.
The question now becomes, what does this mean for the facilities currently in need of developing a FSMA compliant food safety plan? Well, not much changes other than that there may be some flexibility on enforcement, however facilities needing to comply with these requirements should not take this as a potential opt out to not act. Having the ability for discretion on enforcement decisions will still allow the FDA to impose these regulations on facilities, so being proactive with developing a FSMA compliant food safety system is still the most correct and practical way to go.
We encourage anyone having difficulties in this area or in the general area of Food Safety to reach out to dicentra for further discussions and assistance.
dicentra is a professional food safety consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries.
We can be reached at 1-866-647-3279 or firstname.lastname@example.org.