2004D-0065 - Guidance for Industry: Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Food (Edition 2); Availability
FDA Comment Number : EC3
Submitter : Mr. Jack Hubbard Date & Time: 06/10/2004 05:06:07
Organization : TLR-Total Logistics Resource Inc.
Private Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
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 date errors that will result in penalties once FDA begins implementation of Phas four on August 14, 2004. The lack of 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. Accoridng to FDA records, over 50% of current Prior Notice transmissions are inaccurate of inadequate.
Because the system is clearly not working, we request that Phase Four implementation scheduled for August 13, 2004 be moved back at least six months to enable both FDA and entyr filers to recieve 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 a large amount of legitimate importations and in the unfair assesment of penalties against law abiding importers and entry filers.
We request thta Phase Four implementation of FDA Prior Notice requirement be postponed for six months.