In a nod to one of the more complex aspects of current food manufacturing and FSMA compliance, FDA recently published guidance that it will exercise enforcement discretion for two years over supply-chain requirements for domestic co-manufacturers of human and animal foods, and also under the Foreign Supplier Verification Program (FSVP).
The agency defines “co-manufacturing” as a contractual arrangement whereby a brand owner arranges for a co-manufacturer to manufacture or process food on its behalf. The enforcement delay will give brand owners time to develop new supplier contracts allowing them to share information on ingredient suppliers, such as audits, with their co-manufacturers.
In co-manufacturing, a supply-chain program can be implemented by the brand owner, the co-manufacturer, or both. The agency said it will not take enforcement action against a co-manufacturer that is out of compliance if supplier approval and verification activities are divided between the brand owner and the co-manufacturer.
Co-manufacturers subject to FSMA preventive control requirements and that manufacture or process a raw material or other ingredient received from a supplier are defined as “receiving facilities” under 21 CFR Parts 117 and 507. Receiving facilities that find a hazard in a raw material or ingredients requiring an applied control are required to approve their suppliers for those raw materials or ingredients. But the supply-chain provisions allow an entity other than the receiving facility — such as the brand owner — to conduct supplier verification activities, provided the receiving facility documents its review and assessment of the other entity’s documentation.
When contract prevents a co-manufacturer from being able to review a brand owner’s documentation of supplier verification activities, the co-manufacturer would not be able to verify suppliers based on a review of the brand owner’s documentation. In this situation, the co-manufacturer would need to conduct its own supplier verification activities that might otherwise not be required. The net result would be unnecessary costs to both the co-manufacturer and supplier. If the brand-owner’s supplier approval process is adequate, the co-manufacturers verification activities would not add any greater assurance of safe human or animal food.
In its Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food, the agency said it will not take enforcement action if:
- A brand owner conducts supplier approval activities;
- The co-manufacturer describes these activities in its food safety plan; and
- The co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner.
Similarly, the agency will not take enforcement action if:
- A brand owner determines and/or conducts supplier verification activities for its co-manufacturer;
- The co-manufacturer describes these activities in its food safety plan; and
- The co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner — for example, sampling and testing of the raw material or other ingredient.
The agency said it was exercising enforcement discretion “because the guidance represents a less burdensome policy consistent with the public health,” and is immediately in effect. Implicit in all FDA guidance is that the agency has the authority to take an enforcement action under other regulations should it become necessary to protect public health.
Brand owners and co-manufacturers have until November 6, 2019 to be in compliance with supply chain and FSVP requirements.
Posted in Foods, FSMA Perspective and tagged Charles Breen.