Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -29

Accepted - Volume 2

Comment Record
Commentor Ms. Kathy Means Date/Time 2002-08-30 16:27:52
Organization Produce Marketing Association
Category Association

Comments for FDA General
Questions
1. General Comments August 30, 2002 To: www.fda.gov/dockets/ecomments Re: Docket No. 02N-0278 The Produce Marketing Association (PMA) is pleased to submit these comments to the Food and Drug Administration about the Prior Notice section (Section 307) of Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. PMA is the largest global not-for-profit trade association representing companies that market fresh fruits and vegetables. Our more than 2,400 members range from grower-shippers and supermarket retailers, to hotel and restaurant chains and overseas importers. Within the United States, PMA members handle more than 90% of fresh produce sold at the consumer level. PMA’s purpose is to sustain and enhance an environment that advances the marketing of produce and related products and services. The association is funded primarily by members’ dues, revenues from exhibits, product sales, and meeting registrations. Like FDA, PMA and its members are committed to ensuring a safe and secure food supply, and we appreciate the opportunity to help FDA in this endeavor. Summary FDA’s summary of the legislation notes (among other things) that it: • Amends Section 801 to require prior notice of imported food shipments. The notice is required to provide the article, the manufacturer and shipper, the grower (if known within the specified time in which notice is required), the country of origin, the country from which the article is shipped, and the anticipated port of entry. States that, if notice is not provided, the article shall be refused admission. • Requires the Secretary, after consultation with Secretary of the Treasury, to issue regulations that specify the period of advance notice and says that shall be no less than the minimum amount of time necessary for the Secretary to receive, review, and appropriately respond to such notification. It states the period may not exceed five days. • Requires the Secretary to promulgate proposed and final regulations within 18 months of enactment. If the Secretary fails to meet the deadline, the requirement takes effect upon expiration of the 18-month period. In that event, the default period of notice will be no less than 8 hours and no more than five days. • States that an article of food offered for import and prior notice has not been provided, such article shall be held at the port of entry until the importer, owner, or consignee complies. Directs the Secretary, in carrying out this requirement, to determine whether there is any credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals. • Amends Section 301 making it a prohibited act to import of offer for import an article of food in violation of these requirements. Comments PMA encourages the agency to complete the rule-making on prior notice before the 18-month legislative requirement. If regulations are not made effective by that date, entities would be subject to the prior notice requirement of no less than 8 hours. The fresh fruit and vegetable marketplace is dynamic and highly flexible. Because fresh produce is perishable, and because of volatile market demands, fresh produce moves very quickly through the distribution system. It is not unusual for products to be ordered and well on their way to delivery within 8 hours. This is particularly true for products coming into the United States from Canada and Mexico, two very important fresh produce trading partners. It is also true for some air shipments from other countries. PMA encourages the agency to develop a flexible prior notice rule that takes into account the needs of the fresh produce industry. Eight hours is too long a minimum. One example would be that products grown near the U.S. border in Mexico or Canada could be ordered and ready to cross the border in a couple of hours. Prior notice regulations should be piggybacked onto the Automated Broker Interface (ABI), a component of the Customs Service Automated Commercial System (ACS) that voluntarily allows participants to electronically file required import data. Currently 96% of all entries are filed through ABI. The ACS already interfaces with other government agencies (including FDA through OASIS) to electronically transfer data on import transactions. The Border Release Advanced Screening and Selectivity System (BRASS) then scans the information, verifies the data, establishes an entry and releases the cargo and provides ABI release information. Information provided through ABI is generally consistent with FDA except for grower (if known). Enhancement must be made to electronic data to accommodate linkages, allow flexibility for change in information or entry point, or to allow additional information (such as quantities necessary for Customs) at a later date. Information should be limited to that required by law, and that “grower,” for many “articles” of food will be “unknown.” This is particularly true for commingled shipments and for foods that have undergone some processing in country of origin; “unknown” on notification should not be cause to detain or seek additional information. Notification by FDA should be electronic and immediate. Consequently, FDA port operations must be increased to provide for 24-hour seven days per week coverage. This is particularly important for perishable food products, such as fresh fruits and vegetables. FDA should make a clear separation between “holding” product for failure to provide prior notice and administrative detention under Section 303 (for evidence of adverse health….). Product should be held only until prior notice requirements are met and FDA has an opportunity to review and acknowledge. While being held, the product must be stored in appropriate facilities to protect the quality, integrity, and salability of the product (e.g. cold storage for many fresh produce items). Thank you for the opportunity to present these comments. We are eager to work with the agency in any way that will help it develop and communicate the new rules. Please do not hesitate to call on us. Kathy Means PMA Vice President




EC -29