Docket Management
Docket: 02N-0275 - Bioterrorism Preparedness; Administrative Detention, Section 303
Comment Number: EC -11

Accepted - Volume 2

Comment Record
Commentor Ms. Kathy Means Date/Time 2002-08-30 16:38:28
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-0275 The Produce Marketing Association (PMA) is pleased to submit these comments to the Food and Drug Administration about the Administrative Detention section (Section 303) 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. PMAs 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 FDAs summary of the legislation notes (among other things) that it: Specifies period of detention may not exceed 20 days unless a greater period, not to exceed 30 days, is necessary to enable the Secretary to pursue a seizure under Section 304(a) or to seek an injunction under Section 302. Requires the Secretary to establish regulations for expedited procedures for instituting such actions for perishable foods, such as fresh produce, fresh fish and fresh seafood products. Allows the detention order to require that the article be labeled or marked as detained; requires the article to be removed to a secure facility, as appropriate. Specifies that a detained article may not be transferred until released or detention expires. Specifies an appeals process which requires the Secretary, after providing for an informal hearing, to confirm or terminate an order within 5 days of an appeal. This confirmation or termination shall be considered final agency action. If the Secretary fails to comply with the above requirements, the order is deemed terminated. The appeals process terminates if the Secretary institutes action under Section 304(a) or Section 302. Amends Section 301 making it a prohibited act to transfer an article of food in violation of a detention order or to remove or alter any required mark or label identifying the article as detained. Amends Section 801 to provide for temporary holds at ports of entry. Authorizes an officer or qualified FDA employee to request the Secretary of the Treasury to hold food at the port of entry for a period not to exceed 24 hours. This is to occur when the employee has credible evidence or information that an article of food presents a threat of serious adverse health consequences or death to humans or animals; and the officer needs more time to inspect, examine, or investigate. The request must be approved at the district director level or higher. Directs the Secretary to ask the Secretary of the Treasury to remove a held article to a secure facility, as appropriate. States the article may not be transferred during the holding period. Requires FDA to issue a regulation to expedite hearing procedures for perishable foods. Comments PMA recommends that FDA develop highly expedited procedures for detention and hearings when dealing with perishable commodities, especially fresh fruits and vegetables. Such procedures are needed not only because the fresh produce is perishable, but also because of the strong volatility of the marketplace and prices. Fresh fruit and vegetable marketers operate in a very dynamic industry, and prices on many commodities can fluctuate hourly. PMA supports FDAs role in assuring public/animal health and urges the agency to use the minimum time necessary in dealing with perishable products. In addition, perishable products held under administrative detention must be held in appropriate climatic conditions to maintain product quality, integrity, and salability. 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 -11