The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism 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 and other food-related emergencies.
Along with other provisions, the Act requires that FDA receive prior notification of food, including animal feed that 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 that nation's food supply against terrorist acts and other public health emergencies.
The FDA Food Safety Modernization Act (FSMA) signed January 4th, 2011 aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. On May 5, 2011 the FDA published an interim final rule requiring that 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 potential risks of imported food into the United States.
For Instructions on the Prior Notice System Interface, see Filing Prior Notice, which includes the following resources and more:
- Quick Start Guide (also available in Spanish)
- Step by Step Web System Instructions
- PNSI "Wizards" Step by Step Instructions
- Product Code Builder Tutorial
- Find, Copy and Cancel Web Entries and Prior Notices
- HTS Codes
Guidance Documents and Rules
Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3) Final Rule: Information Required in Prior Notice of Imported Food
- Guidance for Industry: Enforcement Policy Concerning Certain Prior Notice Requirements
Guidance for Industry: Entry Types and Entry Identifiers; Prior Notice of Imported Food Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages Compliance Policy Guide, Guidance for FDA and CBP Staff: Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002