FDA Issues Notice of New Regulations to Ensure Sanitary Transportation of Food
On Friday, April 30, the Food and Drug Administration (FDA) issued an Advance Notice of Proposed Rulemaking (ANPRM) to regulate the transportation of food. The ANPRM applies to shippers, motor and rail carriers, receivers and other persons engaged in food transportation. The forthcoming regulations will create new compliance obligations to reduce risks to human and animal health arising from transportation.
FDA’s action responds to a mandate contained in the Sanitary Food Transportation Act of 2005 (SFTA 2005), which requires the agency to issue regulations ensuring sanitary transportation of food. Through the ANPRM, FDA is seeking information and data from industry stakeholders on various aspects of food transportation so that the new regulations will respond to current practices.
For purposes of the new regulations, "food" would be defined as "articles used for food or drink by man or other animals, chewing gum, and articles used for components of any such article." The term would include live animals intended for food use, and food such as meat and poultry during transport outside of USDA-regulated facilities. FDA’s action is required under Sections 416(b) and (c) of SFTA 2005. Section 416(b) commands FDA to issue regulations to "ensure that food is not transported under conditions that may render the food adulterated." Section 416(c) informs the content of the regulations, which must prescribe practices related to sanitation; packaging, isolation and protective measures; limits on vehicle use; information exchange; and, recordkeeping. Under a separate section of SFTA 2005, food must be deemed adulterated, if it is not transported in accordance with the new regulations.
The ANRPM seeks wide-ranging information and data from industry stakeholders on the following subjects: food transportation operations; sanitation practices; packaging, isolation, and protective measures; limitations on vehicle use; information exchange among stakeholders; recordkeeping practices; co-loading of food and non-food products; State laws and regulations; risk of food borne illness arising from transportation; and, benefits and costs of regulation. In addition to the ANPRM, FDA issued non-binding guidance on practices for sanitary transportation of food.
The comment period for FDA's ANPRM closes on August 30, 2010. We would be happy to provide additional information about this regulatory measure and to assist in preparation of comments. If you have any questions, then please contact Charles Hunnicutt or Michael Higgins in the Transportation practice.