Date: Monday, February 9, 2004 Re:  FDA Enforcement Update- Bioterrorism Act Dear NASA Member: Both the Bureau of Customs and Border Protection (CBP) and the FDA continue to modify the guidelines for complying with the requirements of the Bioterrorism Act that officially went into effect on December 12, 2003. The FDA has decided to take a phased in approach in terms of enforcement. The first phase, which has focused on educating companies on compliance, is scheduled to end on March 12, 2004. Both CBP and FDA are trying to help companies figure out the best way to comply while still meeting the standards set forth in the statute. It is estimated that at least 50% of the prior notices filed to date have not been in compliance with the regulation. The reasons vary and include incomplete information, late filing and inaccurate data. The second phase of enforcement scheduled to run from March 13th to May 12th could include monetary penalties for what CBP or FDA consider "egregious violations" of the rules. The third phase, effective from May 13th to August 12th will see more stringent enforcement that could include held shipments for failure to file prior notice as well as fines for various violations. August 13, 2004 is currently the date scheduled for total enforcement. It is the intention of CBP and FDA to hold any shipment that is not in total compliance after that date. The above information is meant to serve as a guideline and we encourage all companies to continue working towards total compliance. It is also important to note that although holding cargo for violations in the initial phases is not the main focus this is still possible if either the FDA or CBP feels the container warrants further inspection. If you need further information or assistance in complying with these new regulations please do not hesitate to contact us. Sincerely, David Ferris Vice President of Logistics