Nearly 20% of all imports into the U.S. are food and food products. In 2002 Congress passed the Bioterrorism Act as a part of its ongoing effort to combat terrorism - in this instance, by reducing the ability for international terrorists to carry out terrorist attacks in the U.S. by contaminating imported foods.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply or other food-related emergencies.
The Act requires that FDA receive Prior Notice before food is imported or offered for import into the United States. Advance notice of import shipments allows FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies.
On October 9, 2003 the Department of Health and Human Services (HHS) issued two new FDA rules to enhance the security of the food supply, one of which was the Interim Final Rule (IFR) for Prior Notice of Imported Foods.
Since December 12, 2003, Prior Notice must be provided for all food for humans and animals that is imported or offered for import into the United States (Title 21 Code of Federal Regulations (21 CFR), Part 1, Subpart I). Prior notice can be provided in one of two ways:
- The U.S. Customs and Border Protection (CBP, formerly the U.S. Customs Service) modified the Automated Broker Interface of the Automated Commercial Environment(ABI/ACE) to allow prior notice to be submitted to FDA through the existing interface between CBP and FDA.
- The Prior Notice System Interface (PNSI) is available to individuals or companies who cannot, or choose not to, file through CBP. PNSI submissions are expected to include prior notice for shipments through international mail; In-Bond entries or admissions into FTZ by carriers or others who do not need to make a full CBP entry at the time of filing the prior notice; filers or brokers who need to file CBP entries at a time the ACE/OASIS interface is not available, and others who simply prefer to use an interactive system.
FDA issued a final regulation on May 6, 2009, amending the existing requirements in 21 CFR Part 1, Subpart I. Highlights of the changes include but are not limited to the following: The final rule revised the definition of certain terms, such as “Country from which the article is shipped” and added new terms, such as “full address.” The number of days before arrival that a PN can be submitted was revised to state that PN is to be submitted no more than 15 calendars days before arrival if using PNSI and no more than 30 calendar days before arrival if submitting via ABI/ACS. Revisions were made to clarify certain information that must be in a PN. Revisions were also made to the sections describing what happens to food that is imported or offered for import without adequate PN and the consequences of failing to submit adequate PN. More detailed information regarding the amendments can be found via the Federal Register, Volume 73, Number 217.
On May 5, 2011, an additional amendment to the regulations was published as an interim final rule as required by the FDA Food Safety Modernization Act (FSMA). This interim final rule went into effect July 3, 2011. The amendment requires an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing the potential risks of food imported into the United States. See the Interim Final Rule: Information Required in Prior Notice of Imported Food for additional information. In May 2013, FDA issued a final rule that adopts the interim final rule.