October 31, 2008
The Food and Drug Administration (FDA) and the U.S. Customs and Border Protection (CBP) announced a final rule and draft compliance policy guide (CPG) today for "Prior Notice of Imported Food Shipments." The final rule is part of the requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). This rule is part of FDA's efforts to protect the nation's food supply against terrorism and other food-related emergencies. The draft CPG describes FDA and CBP's strategy for enforcing the requirements of the prior notice final rule while maintaining an uninterrupted flow of food imports.
On October 10, 2003, the Secretaries of the Departments of Health and Human Services (HHS) and Homeland Security (DHS) jointly published an interim final rule (IFR) to implement section 307 of the Bioterrorism Act, which requires prior notice to FDA for food imported or offered for import into the United States. The IFR took effect on December 12, 2003, as required by the Bioterrorism Act; however, FDA and CBP gave interested persons 165 days to comment on the provisions of the IFR that we would consider as we developed the final rule. In December 2003, FDA and CBP issued a CPG that described FDA and CBP's enforcement strategy for the IFR.
The final rule, which takes effect on May 6, 2009, revises the IFR in only a few key areas. FDA and CBP also are issuing a companion CPG for the final rule to describe our enforcement strategy.
Highlights of the final rule:
- The final rule retains the timeframes for submitting prior notice that are in the IFR; i.e., information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. In accordance with the FDA-CBP Joint Implementation Plan, we evaluated the feasibility of conducting prior notice reviews in a reduced time period in an effort to more closely harmonize the submissions with CBP timeframes. We determined that the timeframes provided in the IFR represent the minimum amount of time FDA needs to meet our responsibility under the Bioterrorism Act to receive, review, and respond to prior notice submissions.
- To assist importers, the final rule now permits prior notice submissions to be submitted 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.
- The final rule adds a definition for "manufacturer" and provides an alternative for identifying the manufacturer when the registration number is not known. 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.
- When the final rule takes effect, persons currently submitting prior notice using reason code L (unable to determine identity of the manufacturer - providing identity of manufacturer's headquarters) and code M (unable to determine identity of manufacturer or headquarters - providing invoicing firm's identity) per the current IFR CPG no longer will be able to do so. As noted above, the final rule requires the identity of the site-specific manufacturer.
- In the final rule, we exempt from prior notice food in diplomatic pouches based on the authority in Art. 27(3) of The Vienna Convention on Diplomatic Relations (1961), which states: "The diplomatic bag shall not be opened or detained."
- The final rule allows, when certain conditions are met, for the submission of the express consignment operator or carrier tracking number in lieu of the anticipated arrival information, Bill of Lading, or Airway Bill number and flight number, which the IFR required.
- The Prior Notice Final Rule Draft CPG describes our enforcement discretion in the following areas and states FDA and CBP generally will not refuse the following foods that are imported without prior notice: non-commercial (i.e., personal) shipments; gift packs with a single prior notice submission; imported food arriving from/exiting to the same country; seed for cultivation; certain U.S. government shipments; and foreign-to foreign mail and courier shipments to individuals.
- The final rule will be effective on May 6, 2009. We are soliciting comments on the draft CPG and anticipate finalizing the CPG on May 6, 2009. Although comments can be submitted at any time, comments should be submitted by December 8, 2008, to ensure we consider your comment before we begin work on the final version of the CPG. Until the final rule becomes effective and the draft CPG is finalized, the IFR and the IFR CPG remain in effect.
- For more highlights of the rule, see Section II. of the final rule that provides a summary of the significant changes made to the IFR.