FDA Issues New Draft Guidance on Animal Food 'Supply Chain Program' Requirements for Some Importers
The Food and Drug Administration recently issued a new draft guidance document to help animal food facilities comply with supply chain program requirements of animal food preventive controls rules that may in some cases apply to importers. Under the supply chain provisions, similar to requirements for human food facilities, facilities that manufacture or process ingredients from outside suppliers must use approved suppliers and appropriate supplier verification activities, including on-site audits and record reviews of their suppliers.
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FDA’s draft guidance includes information and illustrative examples on who is subject to supply chain program requirements and what activities they must conduct. Supply chain requirements may apply to "receiving facilities" that manufacture or process a raw material or other ingredient from a supplier. Examples of animal food receiving facilities listed in FDA's draft guidance include:
- A facility that receives raw agricultural commodities (RACs) such as corn and then manufactures/processes swine food
- A facility that manufactures a complete and balanced extruded dog food using beef, rice, vitamin premix, and other ingredients
- A facility that manufactures a vitamin-mineral top dress for livestock food using vitamins, minerals, and other ingredients.
Like in human food preventive controls rules, the animal food regulations define the supplier as the establishment that manufactures or processes the food, raises the animal or grows the food provided to a receiving facility “without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature," listing the following as examples:
- A farm that grows RACs such as corn that are supplied to a feed mill
- A facility that manufacturers a vitamin premix that is supplied to a facility that manufactures a complete and balanced extruded dog food
- A facility that manufactures vitamins that are supplied to a facility that manufactures a vitamin-mineral top dress for livestock food.
Entities such as “brokers, food distributors, and cold storage facilities are neither receiving facilities that are required to establish a supply-chain program nor suppliers, because such entities are not manufacturers/processors,” FDA said.
Under the Food Safety Modernization Act, importers that are “receiving facilities” (i.e., that manufacture or process the food that they import) may choose to comply with either the Foreign Supplier Verification Program regulations or the supply chain program requirements of the preventive controls rules for both human and animal food. Importers that choose to implement a supply chain program do not have to conduct FSVP supplier verification activities, though they must still file the data elements at entry required under FSVP, according to a separate FDA fact sheet. Likewise, importers that choose FSVP don’t have to implement supply chain programs.