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Do's for food exporters

Sec. 305: Registration of food facilities: This requires the owner, operator or agent in charge of a (domestic or) foreign facility to register with the FDA not later than December 12, 2003. The facilities covered are those that manufacture, process or hold (in stock) food for consumption in the U.S. Those facilities in the meat, poultry and egg sectors which are under the exclusive jurisdiction of the U.S. Department of Agriculture (USDA), namely, those that do not in addition make, process or hold products that are not governed by the three respective laws on USDA's exclusive jurisdiction, are exempt from the requirement of registration. In case a product is exported to the U.S. after undergoing a process in a third country, only the third country facility is to be registered, if the process is more than de minimis like labelling and repacking. Otherwise, facilities in both countries have to be registered. Fishing vessels engaged in processing must register.

The registering entities have to nominate an agent physically present in the U.S. who will be considered an "emergency contact.''

Sec. 306: Establishment and maintenance of records. This stipulates requirements for creation and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food (that is, one up and one down, vis-a-vis the registering entity). Foreign entities subject to these provisions are those that manufacture, process, pack, transport, distribute or hold food for consumption in the U.S. Farms are exempt from this provision.

Sec. 307: Prior notice of imported food shipments. The notice to the FDA, to be submitted electronically, should be given not more than five days and not less than eight hours in advance for food arriving by waterways (sea/canal etc), four hours (food arriving by air or land/rail) and two hours (land/road). In addition to information currently sent to the FDA for determining admissibility, information identifying the grower ("if known''), the country from which the article is shipped (defined by a new concept called the "FDA Country of Production'' for purposes of this law) and the anticipated time of arrival in the U.S. should be given in the notice. Information on growers is not "optional'' in the sense that if the grower's identity is known, this must be supplied.

Food meant for commercial distribution in the U.S. alone is covered by the regulation and not foods brought by individuals solely for personal/family consumption. But neither the quantity of food, even if small, nor the fact that it is only a sample for analysis and not consumption, is a ground for exemption. Notice must be sent ahead of desptach if the goods are sent by mail.

Sec.303: The FDA can detain food if an officer finds credible evidence or information indicating that an article presents a threat of serious adverse health consequence or death to humans or animals. Consignments can also be detained for total lack of or inadequate prior notice information or are sent by unregistered entities.

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