FDA Announces Enforcement Discretion Under FSMA

On January 4, 2011, Congress enacted the Food Safety Modernization Act (FSMA), aiming to protect the public by ensuring the U.S. food supply is safe through prevention and enforcement. The FSMA included seven foundational rules, which we summarized in our FSMA: Stay Compliant with DTL’s ‘PICTURE’! blog.

FDA originally extended the compliance deadlines for many of the FSMA provisions. However, on January 4, 2018, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FSMA as they apply to certain entities or activities. FDA stated that it will use the enforcement discretion period to “consider the most effective and practical approaches to address issues that have been raised since the FSMA rules became final and provide long-term certainty for stakeholders.”

The enforcement discretion announced today pertains to the following 4 specific regulations:

1. Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food),
2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food),
3. Foreign Supplier Verification Programs rule (FSVP), and
4. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety).

Specifically, FDA will allow enforcement discretion for:

• Certain facilities conducting farm-related activities that are subject to the preventive controls requirements,
  • FDA intends to exercise enforcement discretion for certain facilities that conduct farm-related activities because some establishments that fall outside of the current definition of “farm” conduct activities that are typically conducted by farms. However, because they fall outside of the definition, they are subject to the preventive controls and CGMP requirements.
• Written assurances in the “Customer Provisions” in the PC Human Food, PC Animal Food, FSVP, and Produce Safety Rules provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health,
  • FDA intends to exercise enforcement discretion for the written assurances requirements because FDA has received feedback that certain product distribution chains would require vastly more written assurances and resources to comply than was anticipated by FDA
• Importation of food contact substances under FSVP, and
  • FDA intends to exercise enforcement discretion for food contact substances under FSVP because the FDA has determined that certain characteristics related to the nature of food contact substances, FDA’s premarket review and oversight of food contact substances, and the regulatory framework for these substances, it is appropriate to exercise enforcement discretion with regards to the FSVP regulation.
• Certain manufacturing/processing activities for human food by-products for use as animal food.
  • Because FDA has identified some activities it does not consider to be further manufacturing/processing for the purpose of determining whether the human food facility is subject to just the limited holding and distribution CGMPs, or full range of PC and CGMP requirements, FDA intends to exercise enforcement discretion for the following activities:
    • Drying/dehydrating, evaporating, pressing, chopping and similar activities to reduce weight, bulk, or volume and/or
    • Mixing, centrifuging, and similar activities to combine ingredients or separate components (e.g., water and solids)
  • However, enforcement discretion does not apply when these activities are performed to prevent or significantly minimize animal food hazards, or when these activities introduce animal food hazards.

The best way to comply with, and keep up to date with FSMA updates, is to have an expert by your side. Diaz Trade Law specializes in compliance with the FDA and other regulatory government agencies. For information on FSMA, contact us at 305-456-3830 or via email at info@diaztradelaw.com.