| 2002N-0278 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Reopening of Comment Period|
|FDA Comment Number :||EC427|
|Submitter :||Mr. Dave Baglein||Date & Time:||05/17/2004 06:05:21|
|Organization :||Hoyt Shepston and Sciaroni Inc.|
| The Prior Notice requirements of the Bioterrorism Act are not working on the FDA side nor on the side of filers nationwide. FDA is currently unable to notify filers when there are data errors that will result in penalties once FDA begins implementation of Phase Four on August 14,2004. The lack fof information available to filers regarding the nature and scope of errors does not bode well for the flow of legitimate trade in the near future. According to FDA redcords,over 50% of currrent Prior Notice transmissions are inaccurate of inadequate. Because the system is clearly not working,we request that Phase Four impelemention scheduled for Aug. 13,2004, be moved back to at least 6 months to enable both FDA and entry filers to receive proper training. The Act was made into law to protect our food supply. As it stands now,it will not protect our food supply but will surely result in the refusal of large amount of legitimate importations and in the unfair assessments of penalties against law abiding importers and entry filers.
We request that Phase Four implementation fo FDA Prior Notice requirement be postponed for six months.