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FDA offers draft guidance on FSMA animal food guidelines

Draft guidance to help animal food facilities needing supply chain program under FSMA animal food rule.

The U.S. Food & Drug Administration issued draft guidance to help animal food facilities needing a supply chain program meet those requirements under the Current Good Manufacturing Practice (CGMP), Hazard Analysis and Risk-Based Preventive Controls for Food for Animals rule.

The animal food preventive controls rule mandated by FDA's 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When finalized, the draft guidance, titled “Guidance for Industry #246: Hazard Analysis & Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program,” will help receiving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 that their supplier is controlling the hazard in raw materials or other ingredients;
  • Establish the 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In addition, the draft guidance provides clarification for receiving facilities that are also animal food importers that are subject to the supply chain program requirements of the Foreign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 Program (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 A draft guidance to help importers meet the requirements of the FSVP rule is available at FDA.gov.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:

  • A 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 = six 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.
  • A 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 Sept. 18, 2017, or six months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with part 507.

FDA is seeking public comment on this this draft guidance for 180 days.

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