In review of the Food Safety Modernization Act final rule on “Sanitary Transportation of Human and Animal Food,” the American Feed Industry Association (AFIA) finds the FDA made changes requested by the animal food industry to provide flexibility but added some inconsistent exemptions to the rule. The cost of implementing these requirements remains high. FDA estimates $113 to $117 million per year and AFIA believes they have yet to quantify any benefit to implementing this final rule.

FDA acknowledged industry best practices in several places, most notably in the change from the proposed rule that would have required documentation of three previous loads for bulk containers. FDA was persuaded by the comments from AFIA and others, and will now require the carrier to provide, on request from the shipper (when such function is the subject of a written agreement between the shipper and the carrier as provided for under § 1.908(b)(4)), information about the last previous cargo transported in a bulk vehicle.

AFIA also asked FDA that 21 CFR, Part 11 (electronic records and signature rule) should not be mandated for records required under this rule. FDA agreed that redesigning large numbers of existing electronic records and recordkeeping systems would create a substantial burden disproportionate to the public health need and electronic records are exempt from the requirements of Part 11. This change is the same that FDA made to the “Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals” final rule. AFIA is appreciative of this change.

FDA did change the transportation operations for human food coproducts intended for animal food that are not further processed are exempt from the requirements of the rule. If the human food coproducts are being sent for further processing, then FDA concluded they are not exempt as the recordkeeping and inspection requirements are appropriate and not burdensome.

AFIA questions why this exemption was given for a product that is not further processed going straight to a farm, but AFIA’s request of exemption for finished animal feed going to a farm was not granted. The risk based determination FDA used for human food coproducts should be the same for finished animal feed.