Phase 2 of CBP/FDA Discretionary Enforcement Plan For Prior Notice of Imported Food Began March 12, 2004
U.S. Customs and Border Protection (CBP) has issued a notice announcing that Phase 2 of the discretionary enforcement plan for the Prior Notice (PN) requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) was implemented on March 12, 2004 and will run through May 12, 2004.
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(On October 10, 2003, the Food and Drug Administration (FDA) published two interim final rules implementing the PN and Registration requirements of the Bioterrorism Act. Although the requirements of the Bioterrorism Act technically entered into force on December 12, 2003, FDA and CBP agreed to an eight month phase-in period for enforcement of the PN requirement (i.e., from December 12, 2003 through August 12, 2004).)
In Phase 2, Informed Compliance Notices, Penalties to be Issued
During Phase 2, FDA will provide information to CBP regarding those entities that have failed to file PN data as required, and CBP will issue informed compliance notices to those entities that the FDA has identified as non-compliant.
Phase 2 enforcement also includes the ability for CBP to issue monetary penalties to egregious violators for non-compliance with the PN filing requirement. The notice states that during this phase-in period, CBP and FDA are committed to pursuing informed compliance prior to the issuance of any Bioterrorism Act-related penalty action.
As a result, CBP will not issue any Bioterrorism Act-related penalties until the later part of Phase 2.
(CBP sources have also stated by phone that penalties would not be issued for the failure to file PN data if such failure is due to a government-caused problem, such as the FDA's recent problems with its OASIS system, which FDA says have been resolved. See future issue of ITT for additional details.)
CBP to Provide Public Notice of Commencement of Penalty Issuance Period
CBP will provide public notice via another Web posting of the commencement of any potential penalty issuance period and will provide basic guidance about the types and amounts of potential penalty actions.
CBP contact - Other Government Agency Branch (202) 927-0300
CBP notice available at http://www.cbp.gov/ImageCache/cgov/content/import/commericial_5fenforcement/bioterrorism/bta_5fphase2_2edoc/v1/bta_5fphase2.doc.
FDA compliance policy guide available at www.cfsan.fda.gov/pn/cpgpn.html.