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FDA to not enforce several problematic FSMA provisions

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FDA will not enforce several problematic provisions in four of the Food Safety Modernization Act (FSMA) rules as the agency works to find long-term solutions to challenges in implementing the provisions, the agency announced Thursday (Jan. 4).

The provisions relate to aspects of the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food.

These provisions are in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Foreign Supplier Verification Programs (FSVP) Rule; and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Rule.

“This action will help reduce the burdens on both industry and government and provide the agency the ability to consider the most effective and efficient way forward,” FDA Commissioner Scott Gottlieb said in a Jan. 4 statement.

“While we’ve been setting in place the public health gains envisioned as part of FSMA by issuing new standards for food safety, we recognize that such a fundamental change in our food safety approach may require adjustments along the way to address issues that had not been previously anticipated,” Gottlieb noted.

“We value the feedback we’ve received on the new rules and understand manufacturers, farmers and other stakeholders have faced certain challenges as they work to implement the new rules,” he continued. “We’re actively working to pursue permanent fixes to some of these remaining issues through rulemaking or other means, but this will take time. That’s why today we released guidance outlining key areas where we intend to exercise enforcement discretion in four of the rules that implement aspects of FSMA; to address certain challenges as we work to find long-term solutions.”

FDA had extended the compliance dates in August 2016 for many of the provisions covered by the enforcement discretion guidance, Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs, but now says it will not enforce the provisions during the enforcement discretion period.

The guidance pertains to:

  • facilities that would be farms except for certain factors and activities;
  • written assurances provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health;
  • FSVP requirements for importers of food contact substances, and
  • the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food.

Why FDA is exercising enforcement discretion

Some establishments that fall outside of the current “farm” definition conduct activities that also are typically conducted on farms, but because those establishments are not considered farms, they are subject to the preventive controls and CGMP requirements, unless another exemption applies, FDA explained in a related fact sheet.

FDA plans to write a rule that could change the way the requirements in the preventive controls rules apply to facilities that conduct activities similar to those that occur on farms, as farms are currently defined, the agency said. The agency said it will exercise enforcement discretion for these requirements until it completes this rulemaking.

On the written assurances provision, FDA said it received feedback that certain product distribution chains would require vastly more written assurances and resources to comply than the agency anticipated during the rulemaking process. FDA plans to hold off on enforcing the written assurance requirements while it considers rulemaking to address these challenges. The Grocery Manufacturers Association said in 2016 that FDA needed a practical solution to not disrupt the flow of products in the food supply chain.

But manufacturers, processors, importers, and farmers are still required to disclose to their customer that the relevant hazards have not been controlled during the enforcement discretion period, FDA noted. And those customers will still need to comply with all other applicable requirements in federal and/or state and local laws, including the statutory prohibition against the introduction or delivery for introduction of adulterated food into interstate commerce, the agency said.

FDA also does not intend to require importers of food contact substances to comply with the requirements of the FSVP rule, but said it will continue to enforce the statutory prohibition against the introduction or delivery for introduction of adulterated food into interstate commerce.

Food contact substances already undergo extensive premarket review through FDA’s Food Contact Notification (FCN) and food additive petition processes, which require petitioners to demonstrate that the intended use of the food contact substance is safe, the agency noted. FDA considers any food contact substance it has not authorized through either of these processes to be adulterated.

Since issuing guidance in 2016, Human Food By-Products For Use As Animal Food, issues have cropped up over how the preventive controls requirements apply to certain activities performed on human food by-products for use as animal food before they are stored or transported and which do not affect their safety profile, FDA noted.

The agency said it 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).

This 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, FDA clarified.

“Our aim is to work constructively with farmers and other producers to achieve our shared goals around food safety,” Gottlieb said. “These steps are part of our ongoing effort to make sure we take the time to get this new framework right, so it can successfully serve the needs of consumers for the long run.”

He added, “We all share the common goal of maintaining the safety and quality of the American food supply. We look forward to continued collaboration with the affected industry, regulatory partners and other stakeholders to make sure that they understand what’s required in a post-FSMA world and to provide the flexibility needed to implement these new standards across a very diverse food supply.”

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