2002N-0276 - Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Reopening of Comment Period
FDA Comment Number : EC377
Submitter : Ms. Susan Hays Date & Time: 05/19/2004 09:05:15
Organization : Wild Bird Feeding Industry
Animal Feed Industry
Category :
Issue Areas/Comments
In response to foreign facilities' need to hire and retain a US agent, this has resulted in needless increased cost for the North American bird food trade. The majority of Canadian firms have hired a firm to be their US Agent instead of relying on an existing relationship with a person who qualifies as a US Agent. The fee associated ranges from $100.00 to $1000.00 per year.

North American firms' requirement for a US Agent does not influence the effectiveness of the Bioterrorism Act. Foreign facilities that ship food products into the US are already registered with their own governments, and their products must meet the regulatory requirements of CBP and FDA, as well as comply with the Prior Notice requirements for food related products. The only requirements for a US Agent are: they must reside or have a place of business in the US and must be physically present in th US. The US Agent is not required to have any knowledge of the facilities' products or processes. The requirement for a US agent adds an unnecessary cost to doing business in the USA. North American facilities that are C-TPAT and FAST members provide sufficient traceability and accountability. Foreign facilities that are compliant with these programs should be allowed to register with the FDA and without the need for a US Agent.