Under new law, agency has several new enforcement mechanisms against adulterated foodBy Peter A. Buxbaum, AJOTOne of the Obama administration’s accomplishments during the recent lame duck session of the 111th Congress was the passage of the FDA Food Safety and Modernization Act which was signed into law by the president on January 4, 2011. The law initiates a number of requirements for domestic as well as foreign food facilities that handle exporting to the United States, some of which took effect immediately and some of which will not take effect for as long as two years. The purpose of the legislation is to reduce food safety risks and foodborne illness. This is an active time for the Food and Drug Administration when it comes to food safety. The agency is currently considering regulations under the Sanitary Food Transportation Act of 2005 which, according to an FDA announcement, would be “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.” Section 416 of the statute directs FDA to issue regulations, which the agency is currently considering, 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.” One of the innovations of the more recent legislation is to provide the FDA with sweeping recall powers over food products. It also loosens the definition of adulterated food so that the FDA can react more responsively to incidents. Currently it can only recommend a voluntary recall. The new law also includes new requirements and fees for importers, certification for high risk food imports, and verification of foreign suppliers. Importers and exporters should carefully examine the major components of the that may affect their business activities, advised Mike Lahar, National Post Entry Supervisor at A.N. Deringer, Inc., an international freight forwarder headquartered in Champlain, N.Y. “What has happened over the last five or six years is that there have been a number of high profile cases of foodborne illnesses that have made a big splash,” said Lahar. “There was a big peanut butter fiasco as well as incidents involving produce such as spinach and tomatoes. The FDA has responded piecemeal as each situation has come up but Congress decided to modernize FDA regulations. Consumers are concerned about the safety of the food they are bringing home from the store.” The former FDA approach to outbreaks of foodborne illnesses has been to propose voluntary guidelines, for greens, for example, after contaminated spinach was found in the food supply. “But there was no formalized legislation that allowed the FDA to address these problems with a one-stop shopping approach,” said Lahar. FDA’s new recall powers gives the agency some teeth that it lacked under the previous regime. “Earlier recalls were all done voluntarily by the manufacturer,” said Lahar. “The FDA would work with the manufacturer but had no authority to demand a recall on products. Under FDMA, the FDA can go to court and enforce a recall of an unwholesome product. The manufacturer still has opportunity to do a voluntary recall which will probably be a much quicker process. The FDA will also will look differently at a situation where there was a than voluntary recall when it comes time to assess fines.” The FDA’s new mandatory recall authority came into effect with the signing of the legislation. Redefining the concept of adulterated food also considerably broadens FDA powers. “The old standard was that food had to be ‘sufficiently adulterated’ before the FDA could take action,” Lahar explained. “Now they only have to find a ‘reasonable probability’ of adulteration. This makes it easier for the FDA to address things. In the past, they had to adhere to a much higher standard of proof.” There are a number of