Only three data elements critical to identifying an article of food or dietary supplement should be required by FDA in prior import notices, the Grocery Manufacturers of America states in April 4 comments.

These elements are the FDA product code (or codes), common or usual name and maximum quantity of the article, according to the group. The comments were submitted in response to a Feb. 3 bioterrorism proposal intended to aid FDA decisions on whether to examine food products offered for importation into the U.S. (¹ Also see "Food Import Prior Notice Proposed Rule Allows Amendments, Not Appeals" - Pink Sheet, 3 February, 2003., p. 4).

Under the proposal, information that would be required in a prior notice includes: the purchaser's name and address; the FDA product code; entry type and U.S. Customs number; market and brand name (if applicable); quantity of item expected; lot or manufacturer's code; manufacturer; country of origin; country from which item was shipped; grower; shipper; date and time of arrival; importer; owner and consignee; and carrier.

The amount of data proposed exceeds what is required by the Bioterrorism Preparedness Act of 2002 and has not been justified by the agency, GMA contends.

For instance, "specifying the precise quantity by each package size does nothing but unduly complicate the notice," the trade group remarks, adding "it is difficult to imagine a scenario in which it would be critical for FDA to know in advance that a truck contains a precise quantity" of products.

GMA further maintains that "having the package size information does not facilitate the inspectional process" as the agency must unload the entire shipment to ascertain whether such information is correct and "if FDA does that, it has already made the decision to inspect the shipment."

"It is conceivable that the system that FDA has proposed will increase the risks to the security of the food supply, rather than add to it," the association points out.

"If fully loaded trucks are required to delay their departure or arrival at ports of entry to comply with unreasonable prior notice requirements, the opportunity for malicious activity involving the product on those trucks increases."

Besides streamlining information required in prior notices, GMA advises FDA to provide for an optional notice for "regular recurring shipments of essentially the same or a limited array of articles of food."

By allowing an optional notice that covers routine shipments over an extended period of time, "companies would be spared the task of daily notices and amendments, while FDA would be given even more advance notice of imports than even the Bioterrorism Act contemplates," GMA points out.

In separate April 4 comments, the Consumer Healthcare Products Association requests FDA clarify how the proposal is expected to prevent "the possibility that food ingredients intended for non-food (i.e., drug) uses may be held up as a result of confusion at the docks for what would be assumed to be a food."

Although food imported for non-food uses - such as inactive ingredients in drug products - are exempt from prior notice requirements, CHPA questions whether "this distinction will operate in the real world" to prevent "unnecessary 'holds' on imported ingredients."

Drug manufacturers sometimes import samples of "foods" for use in drug product formulation testing in the R&D stage, CHPA points out. "How can these "food" samples be differentiated from food intended for consumption in order to bypass the prior notice requirements?"

The American Herbal Products Association asks that the agency exempt from the notice requirement "all food imported for personal use," whether carried by an individual or shipped to an individual. The proposal currently exempts food for personal use that is carried in that individual's personal baggage.

This change is important as "many foreign firms have developed their U.S. business by making food products available to individual consumers...via Internet sites and by mail order," AHPA says.

Several trade groups argued against the rigidity of the time periods specified for submission of notices. The associations also requested the agency expand opportunities provided for amending prior notices.

"The inflexibility of the time periods for the provision of the information [and] the lack of provision to change information that has been provided when change is endemic to the business...suggest a strong likelihood that the multiple component parts of the prior notice system will not interact in a seamless and efficient way, leading to systemic failure," GMA maintains.

Specifically, GMA asks FDA to abandon the requirement that prior notice must be filed by noon of the day before the food is scheduled to arrive at port of entry "in favor of a more flexible rolling notice period."

Potential problems "would largely disappear" with a system where prior notice could be filed four or eight hours before arrival, according to GMA. "The shorter notice should apply in the case of product arriving from contiguous countries, especially by truck or rail and the eight-hour period should apply to product arriving by other means or from other places," the trade group says.

In their respective comments, GMA, CHPA, AHPA and the Council for Responsible Nutrition each argue for more leniency from FDA concerning the filing of amendments to prior notices; under the proposed rule, firms may only make one amendment assuming the need for the revision was known and documented in the initial notice.

The associations suggest more accurate notices might result from a system in which an amendment could be filed even when its need was not anticipated previously and when multiple amendments are allowed.

Despite its suggestions for modifying the agency's proposal, GMA expresses substantial concern with the workability of the overall scheme. "FDA should be clear: we do not think that making changes on the margins can cure the problems with the proposed prior notice system [and] we do not believe...that the current proposal will work."

Instead, "we strongly suggest that FDA re-examine the proposal with the goal of commercial practicality and feasibility" in mind and "make it simpler and more flexible."

If FDA focuses on ways to better utilize information collected through the recently integrated Customs Service's Automated Commercial System and the agency's Operational and Administrative System for Import Support, synergies between the two might provide a solid foundation for a more workable prior notice system, GMA suggests.

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