The agency said the regulation is part of its efforts to protect the nation's food supply against terrorism and other food-related emergencies.
The rule, which is part of the requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, will be effective on May 6 2009. FDA’s draft compliance policy guide sets out how the agency – together with the US Customs and Border Protection (CBP) – plans to enforce the requirements of the rule.
FDA has called for comments on the draft CPG, which it plans to finalize by the time the final rule becomes effective.
The final rule follows an interim final rule that has been in effect since October 2003. It requires FDA to be notified prior to any import of food into the United States.
Two of the main areas in which the final rule revises the interim final rule are:
- The final rule permits prior notice submissions to be made no more than 15 calendar days before the anticipated date of arrival for submissions made through FDA's Prior Notice System Interface (PNSI) and no more than 30 calendar days before the anticipated date of arrival for submission made through CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS), instead of the 5 calendar days required in the IFR.
- In addition to the name of the manufacturer, the submitter must submit either: (a) the registration number of the facility associated with the article of food; or (b) the full address of the site-specific facility and reason why no registration number is being provided. The IFR generally only allowed for the submission of the name of the manufacturer and its registration number.
To access the final rule, click here.