June 14, 2018
Today, the U.S. Food and Drug Administration issued draft guidance to help animal food facilities needing a supply-chain program meet those requirements under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food rule).
The animal food preventive controls requirements mandated by the FDA Food Safety Modernization Act (FSMA) require animal food manufacturers receiving raw materials and ingredients to develop and implement a risk-based supply-chain program when the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard in an incoming ingredient. Not all receiving facilities will need a supply-chain program, such as when they are controlling hazards themselves. When finalized, the draft guidance issued today, entitled “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program,” will help receiving facilities:
- 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In addition, the draft guidance provides clarification for receiving facilities that are also animal food importers that are subject to the supply-chain program requirements of the Foreign Supplier Verification Programs (FSVP) rule. A draft guidance to help importers meet the requirements of the FSVP rule is available at FDA.gov.
Compliance dates are determined based on the size of the facility and the requirements that apply to its suppliers. Specifically:
- Receiving facility is not a small business or a very small business and its supplier will be subject to the CGMPs, but not the preventive control requirements, of part 507.
Compliance Date: 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the CGMP requirements of part 507.
- Receiving facility is not a small business or a very small business and its supplier is subject to part 507.
Compliance Date: The later of September 18, 2017 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with part 507.
The FDA is seeking public comment on this this draft guidance for 180 days.
For questions, Contact CVM.