The rule, which has already been operative, adds an additional element to the existing prior notice regime, that is the requirement to notify the agency if an article of food being brought in to the United States, including animal food, has been refused entry by another country.
"FDA's action reinforces an existing requirement that importers have to notify FDA if any product offered for import into the U.S. had been previously rejected by another country. FDA clarified that such notification only applies to foreign country rejections that were related to food safety," Joseph A. Levitt, partner with the law firm Hogan Lovells US LLP told FoodNavigator-USA. Leavitt is the former director of the FDA’s Center for Food Safety and Applied Nutrition.
The Bioterrorism Act of 2002 already required all importers to notify FDA ahead of any shipments of food into the United States. This would allow FDA to triage the entries and sample based on risk. The additional rule finalized Thursday completes the rulemaking process without any changes from the Interim Final Rule.
Food importers can submit electronic prior notices either through a system run by the US Customs and Border Protection agency or through FDA’s system. According to FDA, in calendar year 2011, 10,537,372 prior notices were submitted, 9,054,230 of which were submitted through the CBP system with the remaining 1,483,142 being submitted through the FDA system.
Clarification on 'refused entry'
Experts familiar with the rulemaking process say it is not unusual for FDA (or other agencies) to finalize rules without making any of the changes suggested in the comments. In its responses to the comments, FDA did agree that “refused entry” should be understood to refer solely to articles of food that were refused entry into another country for food safety reasons, and not for other reasons, such as inadequate paperwork or noncompliant packaging, and that these instances need not be reported. Other comments suggested FDA require even more information, such as the specific reasons why an article of food was refused entry by another country. FDA declined to add this added provision to the rule, but said that in individual cases it might contact the food importer directly for more information.
FSMA, whichi was signed in to law by President Obama on Jan. 4, 2011, has been called the most sweeping change in food safety legislation in decades. In addition to the rule finalized yesterday, another provision has been operative for a number of months, and that is the requirement for all food facilities, both domestic and those foreign facilities exporting food to the US, to submit updated food facility registrations. The deadline for submitting those initial re-registrations was the end of January and the law requires them to updated biannually. Any food facility that does has not have a facility registration dated either late 2012 or early 2013 is in violation of this provision.