FDA Posts New Guidance on 'Supply Chain Program' Requirements for Some Food Importers

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.

Requirements Apply to Manufacturers and Processors Using Ingredients From Suppliers

Under the human food preventive controls regulations, a “receiving facility” is a facility that “manufactures/processes a raw material or other ingredient that it receives from a supplier.” Examples of “receiving facilities” that may be subject to supply chain program requirements include facilities that receive ingredients from a supplier to:

• Manufacture or process produce raw agricultural commodities into bagged salads
• Mill grains such as wheat to make flour
• Manufacture cookies using flour, sugar and other ingredients.

Similarly to the FSVP regulation, the human food supply chain program rules 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.” Entities such as “brokers, produce aggregators, 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.

Supply Chain Program Must Include Supplier Approval, Verification

Under the final rule on preventive controls for human food (see 1509100021), “receiving facilities” must implement supply chain programs that include the use of approved suppliers, considering that supplier’s compliance history, processes and other factors, and verification of those suppliers, including by onsite audit, sampling or testing of the ingredient, and review of the supplier’s records. Verification activities must be documented. If a control is applied by another entity in the supply chain other than the supplier, the receiving facility must have documentation of that entity’s verification of the supplier, FDA said.

Corporate parent may develop and implement program. A receiving facility’s corporate parent may be “active in developing and implementing your food safety plan,” FDA said. An individual at the corporate level may be the preventive controls qualified individual, and approval of suppliers, verification and recordkeeping may be handled at the corporate level.

Exemptions. In addition to the exemption for importers that comply with the FSVP regulations, food supplied for research or evaluation is exempt, as is food when the receiving facility will control the hazard at its own facility, “regardless of whether your supplier has also applied one or more preventive controls for that hazard to raw materials and other ingredients that your supplier provides to you,” FDA said. “In addition, you are not required to implement a preventive control if you comply with certain requirements for ensuring a hazard will be controlled by your customer or subsequent entity in the distribution chain,” FDA said.

Modified requirements. Food from small business “qualified facilities” is subject to modified requirements, as is food from suppliers in cases when an entity other than the supplier applies food safety controls. This may be the case for produce when the food is grown, harvested and packed under different management, FDA said.