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 : EC381
Submitter : Mr. Martin Rice Date & Time: 05/19/2004 09:05:48
Organization : Canadian Pork Council
Other Organization
Category :
Issue Areas/Comments
GENERAL
GENERAL
The Canadian Pork Council (CPC) is pleased to have the opportunity to submit feedback to the FDA regarding Docket: 2002N-0276 - Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The following comments are being submitted specifically on behalf of one of CPCs members, the Ontario Pork Producers Marketing Board (OPPMB).

Sincerely,
Martin T. Rice

Regarding the costs related to hiring a US Agent:
1. The costs to a foreign facility of hiring a U.S. agent;

Ontario Pork's cost of hiring a U.S. agent is a $14.00 entry fee per load of market hogs crossed plus $1.50 per prior notice for information processing.

2. The number of foreign facilities that have hired a U.S. agent or negotiated additional duties from someone with whom they have an existing relationship, in response to the Interim Final Rules, instead of relying on an existing relationship with a person who qualifies as a U.S. agent;

OPPMB has relied on its existing broker relationship in response to the Interim Final Rules. Its sales representative now acts as its U.S. Agent.

3. The number of foreign facilities that have ceased exporting to the United States because they have decided not to hire/retain a U.S. agent for registration purposes;

Having to designate a U.S. agent has not effected OPPMB's exporting practices. Relationships with U.S. customers are its paramount concern.

4. The distribution of costs between submitting registrations and other services offered by the U.S. agent;

Previous to the Bioterrorism Act, OPPMB was billed an entry fee of $14.00 per load of market hogs crossed. After the Act implementation day, in addition to the $14.00 service charge, an FDA Prior Notice fee of $1.50/load is incurred to process prior notice information.

5. The assumptions underlying FDA's estimates of the costs of hiring and retaining a U.S. agent.

Although costs associated with Bioterrorism Act compliance have increased, other economical factors may have a larger impact on U.S. export
opportunities than this particular regulation.