Bioterrorism Act Enforcement

An article by Peter A. Quinter.

This Friday, August 13, 2004, is the first day of enforced compliance by both the FDA and U.S. Customs and Border Protection (CBP) of the Bioterrorism Act. From December 12, 2003 through August 12, 2004, FDA and CBP have been a transitional, educational, informed compliance mode, but that is over. According to a recently issued memorandum from the CBP Assistant Commissioner for Field Operations, in Washington, D.C., monetary penalties will be issued for violations such as failure to submit the required prior notice, late filing of the prior notice, and inaccurate information filed as part of the prior notice submission.

IMPORTANT POINTS TO REMEMBER:

1. The penalties by CBP will be issued in an amount equal to the domestic value fo the cargo for which prior notice is not given.
2. The penalties will be assessed against the parties having the information necessary to submit prior notice, but who fail to submit the prior notice (which could be the owner, importer, or consignee).
3. The penalties may be assessed against multiple parties for the same failure to file a prior notice if those parties aided or facilitated the violation.
4. For most prior notice violations, the violator will be offered an Option 1 non-negotiable amount. 5) CBP has issued Penalty Assessment and Mitigation Guidelines which a violator must carefully follow to attempt to reduce the penalty through the Petition process to CBP. The lowest mitigated amount will be $500, but only for the first violation.
5. Being a member of the Customs-Trade Partnership Against Terrorism (C-TPAT) is a mitigating factor.
6. For second or subsequent violations, mitigation by CBP will be much less favorable.

RECOMMENDATIONS:

1. If you have not already done so, visit or website, www.fda-usa.com, to learn more about the Bioterrorism Act and to easily register with the FDA any U.S. or foreign food manufacturing, holding or transportation facilities.
2. If a prior notice violation occurs, and food is being HELD, DETAINED, or REFUSED, contact us to discuss quickly appealling the FDA or CBP actions.
3. If a penalty or liquidated damages claim is issued by CBP, contact us to discuss reducing the penalty.
4. If you are an importer or customs broker, contact us to discuss joining C-TPAT.

For any questions, contact Deirdre Nero, Esq., at (305) 262-4433 in Miami or dnero@becker-poliakoff.com, or me.

Peter A. Quinter, Esq., Shareholder
Customs and International Trade Department
Becker & Poliakoff, P.A.
3111 Stirling Rd. Ft. Lauderdale, FL
33312 (954) 985-4101 or
1-800-432-7712 (954) 985-4176 Fax
pquinter@becker-poliakoff.com
website: www.becker-poliakoff.com