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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