2002N-0276 - Small Entity Compliance Guides on Registration of Food Facilities and Prior Notice of Imported Food; Availability
FDA Comment Number : EC359
Submitter : Mr. Alejandro Casiro Date & Time: 05/19/2004 08:05:10
Organization : Government of Argentina
International Government
Category :
Issue Areas/Comments
Docket Nr. 2002N-0276

Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparadness and Response Act of 2002; Reopening of Comment Period.


The Government of the Argentine Republic submits the following comments on the regulation of the above referenced Act.

1. The Government of the Argentine Republic supports the efforts carried out by the United States in its struggle against international terrorism, through laws and procedures which increase security levels for the international community.

2. In reference to the new requirement to hire and retain an agent in the United States, the Government of the Argentine Republic considers that for many firms this could give rise to an increase in costs, which will vary according to the services that are contracted and depending on the operations of each firm. The fulfillment of such requirement may lead many small and medium size firms to desist from exporting to the US market, since they do not have the necessary tools and although they may produce quality products, they cannot compete via costs.

3. The Government of the Argentine Republic considers that it would be suitable to stress the need for FDA to organize periodical training courses primarily addressed to small and medium size companies, in order to train them in issues related to registration and prior notification. It would be interesting to organize courses in each region, giving all interested parties the opportunity to attend.

4. The Government of the Argentine Republic considers that it would be useful to extend the transition periods before the effective implementation of regulations emanating from the Bioterrorism Act, so that firms exporting to the U.S.A. have enough time to adapt to the new requirements.

5. The US Government should consider that, in the case of developing countries, the need to comply with the new requirements could result in their exclusion from trading with the U.S.A. For this reason, it is necessary to adopt all necessary measures to reinforce training and also to extend the scheduled implementation deadlines.