Docket Management
Docket: 02N-0277 - Bioterrorism Preparedness; Establishment and Maintenance of Records, Section 306
Comment Number: EC -21

Accepted - Volume 2

Comment Record
Commentor Ms. Kathy Means Date/Time 2002-08-30 16:31:53
Organization Produce Marketing Association
Category Association

Comments for FDA General
1. General Comments August 30, 2002 To: Re: Docket No. 02N-0277 The Produce Marketing Association (PMA) is pleased to submit these comments to the Food and Drug Administration about the Recordkeeping section (Section 306) 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 Chapter IV to authorize the Secretary to have access to certain records when there is a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. It applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of the food. It excludes farms and restaurants. It also excludes information such as recipes, financial data, personnel data, research data, and sales data (other than shipment data regarding sales). • Requires the Secretary to promulgate proposed and final regulations within 18 months of enactment to establish requirements for the establishment and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food. Limits recordkeeping requirement to two years. • Directs the Secretary to consider the size of a business in promulgating the regulations. • Directs the Secretary to take appropriate measures to ensure protection from disclosure of sensitive information. Comments PMA recommends that FDA establish a definition for businesses exempt under the act, including “farms” and “restaurants.” We recommend that the definition of “farm” include typical post-harvest farming operations such as packing/packaging, washing, grading, waxing, sizing, cooling, application of inventory control items (e.g. price lookup stickers or universal product codes), conventional storage, controlled-atmosphere storage, transportation from the fields, transportation to storage or processing facilities, and transportation from the farm. These activities should be included in the definition of “farm” whether they are conducted in the field or in a packinghouse. For the definition of “restaurant,” we recommend that foodservice operations in retail supermarkets, convenience stores, noncommercial foodservice operations (e.g. hospital/prison cafeterias), and worksite foodservice operations (e.g. company cafeterias) be included. PMA recommends that FDA allow for the use of available documents to satisfy any inspection requirements. Each regulated business should have the flexibility to determine whether a different record is needed and what that record should be. This approach minimizes recordkeeping burdens and accommodates the diversity and complexity of the channels of trade within the food chain and differences in the operational characteristics of individual food businesses. PMA recommends flexibility in determining the immediate previous source and immediate subsequent source of the food. The degree that specificity of immediate previous sources can be identified will vary based on numerous factors. For example, fresh produce is often commingled to meet marketplace needs. FDA should recognize that in some cases information can be obtained that may reduce the number of potential sources for a specific food, but not necessarily identify the exact immediate previous source. FDA should not require new and unnecessary records. Given that Section 414(b) potentially affects a huge number of businesses, it is impractical and unnecessary to impose a single, specified record system that does not provide needed flexibility to accommodate the diversity of the channels of trade for food. Regulated businesses should be given the flexibility to modify existing records to prevent disclosure of confidential or trade secret information. Information regarding packaging should be restricted to the food contact portion of the package and not extend beyond the packaging manufacturer with respect to information about immediate previous source – that is the sources of materials used by the packaging manufacturer are not appropriate as immediate previous source(s). The size of a business should be considered in establishing appropriate implementation/effective dates for the proposed regulation and consideration should be given to exempting selected business based on size. Because fresh fruits and vegetables are highly perishable, record maintenance periods can be appropriately shorter than for foods that are not perishable. Although some commodities can be stored by the grower/packer for several months, once fresh produce begins to move through the distribution system, it remains in the distribution system for several weeks at most. Although PMA does not recommend that the agency develop many different record maintenance periods because that would complicate compliance, we do recommend that record maintenance rules for highly perishable products such as fresh fruits and vegetables be significantly shorter than those for nonperishable foods and appropriate to their perishability. 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 -21