FDA takes a common sense approach in Final Rule for Imported Foods requiring notice of another country's refusal to allow entry to be reported if the refusal relates to food safety concerns.

In calendar year 2011 more than 10.5 million prior notices were submitted, 9 million were submitted through the Customs and Border Patrol system with the remaining 1.5 million submitted through the FDA system. Even though FDA estimates that its final rule entitled "Information Required in Prior Notice of Imported Food http://www.gpo.gov/fdsys/pkg/FR-2011-05-05/pdf/2011-10955.pdf only adds about 1 minute to each import entry it reviews, FDA was unable to quantify or otherwise demonstrate benefits from the rule. FDA did conclude that "potential benefits can result from FDA's ability to use the additional information to better identify imported food shipments that may pose a safety or security risk to U.S. consumers." The final rule will be published on May 30, 2013.

Citing often repeated but close to impossible to verify CDC data, FDA concludes there is a "largely preventable" public health burden stating "[e]ach year about 48 million people (1 in 6 Americans) get sick; 128,000 are hospitalized; and 3,000 die from food borne diseases (http://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html). Despite these generalized estimates concerning all aspects of the food supply, including consumer handling, no data is provided concerning imports.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 added section 801(m) to the Food Drug and Cosmetic Act requiring that FDA obtain information about imported foods before arrival in the United States. It also provided that an article of food imported or offered for import is subject to refusal of admission into the United States unless adequate prior notice has been provided to FDA. Section 304 of the Food Safety Modernization Act (FSMA), signed into law by President Obama on January 4, 2011, further amended the FDCA requiring prior notice identifying "any country to which the [food] article has been refused entry."

In its Notice https://www.federalregister.gov/articles/2013/05/30/2013-12833/information-required-in-prior-notice-of-imported-food?source=govdelivery FDA clarified that the phrase "refused entry" only includes refusals related to "food safety." FDA stated that it "considers 'refused entry' to mean a refusal of entry or admission of human or animal food based on food safety reasons, such as intentional or unintentional contamination of an article of food." While the Act and the Final Rule do not specify refusals based on food safety concerns, FDA "agreed" that only refusals for food safety reasons should be reported.

FDA further clarified that the phrase "article of food" refers only to the specific food item for which the Prior Notice is being submitted. FDA stated that is will not consider the phrase an "'article of food' to refer to food from the same batch or lot that is not being imported or offered for import into the United States and for which Prior Notice will not be submitted, or to refer to food of a similar type that was previously refused entry by a country." FDA provides an illustration where "Country A refuses entry, this fact is not submitted as part of prior notice for the portion that had been shipped to the United States."

In determining whether there has been a violation of the prior notice regulations, FDA will look at the "totality of the circumstances" and will follow its compliance policy guide entitled "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm153055.htm). Among the considerations in enforcing a violation, FDA will "take into account the severity of the violations, whether they are flagrant, and whether the person has had previous violations, particularly if they were similar types of violations."

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