Phase 3 of CBP/FDA Discretionary Enforcement Plan For Prior Notice of Imported Food Delayed Until May 19, 2004
According to sources at the Food and Drug Administration (FDA), Phase 3 of the FDA/U.S. Customs and Border Protection (CBP) discretionary enforcement plan for the Prior Notice (PN) requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) is to be implemented on May 19, 2004 (instead of May 13, 2004).
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CBP sources state that FDA and CBP have decided to delay Phase 3 implementation due to scheduling issues associated with software programming.
(In December 2003, FDA issued a Compliance Policy Guide for FDA and CBP staff which, among other things, describes the discretionary enforcement plan FDA/CBP are using during the eight months following the December 12, 2003 PN effective date (i.e., from December 12, 2003 through August 12, 2004).)
Full ABI Edits for FDA PN Data to Go into Effect on May 19, 2004
CBP has issued an administrative message stating that full Automated Broker Interface (ABI) edits for FDA PN data will go into effect on May 19, 2004. (These full ABI edits are the cornerstone of Phase 3.)
CBP has previously stated that on and after implementation of full ABI edits, entries submitted through ABI that contain a tariff number coded FD3 (unless disclaimed) or FD4 will be rejected by ABI if they do not contain full PN data.
In addition, CBP has previously stated that for in-bond types 61 (IT) and 62 (T&E), the PN data must be filed and 'accepted' (passed all ABI edits and received a PN confirmation number) before authorization for movement is granted.
Also on and after May 19, 2004, CBP has previously stated that ABI warnings will no longer be generated for missing or incomplete PN data for transactions sent on and after May 19, 2004.
(See today's ITT, 04051405, for BP summary of CBP administrative message on delay in full ABI edits, the warnings that will become fatal errors, etc.)
Phase 3 Suggested Actions for PN Violations
In its Compliance Policy Guide, the FDA states that CBP and FDA staff typically should consider taking the following actions for violations involving shipments of food, other than food carried by or otherwise accompanying an individual or food arriving by international mail, during Phase 3 (i.e. May 19, 2004 - August 12, 2004):
| Violation due to: | Category 2 |
|---|---|
| No PN | Refusal and/or CBP civil monetary penalties |
| Inaccurate PN, untimely PN, or unregistered facility | Assess CBP civil monetary penalties |
(The three categories of violations are: Category 1 - credible information of threat of serious adverse health results; Category 2 - history of violative conduct of a similar nature by a person so notified, or apparent intentional or flagrant violations; and Category 3 - All violations other than those of Category 1 or 2.)
In Phase 2, the suggested action for this Category 3 violation was education/communication; analysis of data for compliance action.
In Phase 2, the suggested action for this Category 2 violation was only assessment of CBP civil monetary penalties.
In Phase 2, the suggested action for this Category 2 violation was education/communication; analysis of data for compliance action.
(For all other violation/category combinations, the FDA's suggested action is the same for both Phase 2 and Phase 3.)
FDA's Compliance Policy Guide also contains similar tables for food carried by or otherwise accompanying an individual, as well as food arriving by international mail.
(See ITT's Online Archives or 12/12/03 and 12/15/03 news, 03121207 and 03121505, for BP summary and update of FDA's Compliance Policy Guide.)
CBP Adm 04-1239 (dated 05/12/04) available via email or fax by emailing documents@brokerpower.com
FDA Compliance Policy Guide (dated December 2003) available atwww.cfsan.fda.gov/pn/cpgpn.html