FDA announcement seeks industry input
By Peter A. Buxbaum, AJOT
Back in April, the Food and Drug Administration announced an Advance Notice of Proposed Rulemaking (ANPRM) on implementing the Sanitary Food Transportation Act of 2005. The announcement was described as “the first step in writing federal regulations that will govern sanitary practices by shippers, carriers, receivers, and others engaged in the transportation of food products for humans and animals.”
Predictably, carriers, shippers, and trade groups alike reacted to the announcement by touting the excellent record they have in preventing the spread of foodborne illnesses during the transportation process. Very few such cases have come to light in recent decades, they noted. The industry does not require any new specific dos and don’ts, they contended.
The only problem is that Congress mandated the that FDA promulgate regulations for sanitary food transportation. Section 416 of the statute directs FDA to issue regulations that require shippers and carriers by motor vehicle among others to “use sanitary transportation practices…to ensure that food is not transported under conditions that may render the food adulterated.” Under the law, food is considered to be adulterated if it is “transported…under conditions that are not in compliance with regulations…” Those regulations are already overdo.
The ANPRM requested input on the issue from the food and transportation industries and consumer interest organizations. FDA will propose specific regulations to implement the statute “After evaluating comments received in response to the ANPRM,” FDA promised.
Industry’s fallback position is to try to read the tea leaves to divine which way FDA is leaning and to urge it to take the least onerous approach—for example, requiring companies to develop risk mitigation plans—rather than mandating specific standards of behavior.
The American Association of Railroads “is unaware of recent instances of food contamination in the railroad industry,” said Michael Rush, counsel for the AAR. “FDA cited two instances of food contamination from rail transport, one dating all the way back to 1974 and one that occurred in 1989. it is significant that FDA only cites instances that occurred 36 and 21 years ago.”
In all, the ANPRM cited six instances of improper transportation of food products over the last 36 years, four of which incidents resulted in transportation-caused foodborne illnesses.
“Existing laws and regulations are working,” said Erik Lieberman, regulatory counsel at the Food Marketing Institute, a trade group representing 26,000 retail food stores and 14,000 pharmacies. “The few incidents FDA cites in the ANPRM involving issues in the transportation of food are violations of current law and regulations. As such, the development of additional food transportation related guidance clarifying the responsibilities of food transporters is the best way to achieve the goals of the” 2005 law.
One clue to the FDA’s thinking on the subject were the questions the agency posed to industry stakeholders as part of the information-gathering process. These questions covered industry information such as the firms involved, vehicles used and cargo handled by the food transportation industry; current sanitation practices and protective measures; record keeping and information exchanges; risks of food borne illness associated with transportation; and the burdens regulations might impose on small businesses.
The American Trucking Associations discerned that FDA is considering a one-size-fits-all set of regulatory requirements. Such an approach, said Richard Moskowitz, an ATA vice president, “is impracticable and will not improve the safe transportation of food in the United States.”
Instead Moskowitz advocates that the regulations should focus on performance standards rather than specific food handling and transportation methods. “The food shippers themselves are in the best position to determine the appropr