Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.
According to an agency news release, the draft guidance will help facilities in the following areas:
- “Determine whether they need a supply-chain program;
- Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
- Establish frequency of supplier verification activities;
- Meet documentation and recordkeeping requirements; and
- Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”
In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.
The FDA is accepting public comments on the draft for the next 180 days.