Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -25

Accepted - Volume 2

Comment Record
Commentor Ms. Kathy Means Date/Time 2002-08-30 16:35:37
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-0276 The Produce Marketing Association (PMA) is pleased to submit these comments to the Food and Drug Administration about the Registration section (Section 305) 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 the Act by adding new section 415 to require registration for food facilities. Requires the owner, operator, or agent in charge of a domestic or foreign facility to submit a registration to the Secretary. For a foreign facility, the registration must include the name of the U.S. agent for the facility. • The registration shall contain information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business and, when determined necessary by the Secretary through guidance, the general food category as identified under 21 CFR 170.3. Requires the registrant to notify the Secretary in a timely manner of changes to such information. • Requires the Secretary to notify the registrant of receipt of the registration and to assign a registration number to each facility. Requires the Secretary to compile and maintain an up-to-date list of registered facilities. Protects the list and any registration documents from disclosure under Section 552 of Title V, U.S. Code. • Defines facility as any factory, warehouse, or establishment of an importer that manufactures, processes, packs, or holds food. Specifically excludes farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer; and fishing vessels (except such vessels engaged in processing as defined in 21 CFR 123.3(k). [Note: this covers animal feed and dietary supplement manufacturers.] Limits foreign facilities to those that manufacture, process, pack, or hold food only if food from such facility is exported to the U.S. without further processing or packaging outside the U.S. • Amends Section 801 to require that an article of food offered for import from an unregistered foreign facility be held at the port of entry until the facility is registered. • Authorizes the Secretary to provide for and encourage the use of electronic methods of registration; however, paper registration is allowed. 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. In the case of “retail food establishment,” FDA should know that in the industry this can be interpreted to mean supermarkets, convenience stores, etc. Further refining the definition of “retail food establishment” is essential. PMA recommends that FDA use a flexible registration process, including options such as allowing a parent corporation to register all subsidiaries on a single registration or to register different divisions of a company separately. Registration of individual facilities should not be required. A corporation should be able to register all its facilities on a single registration. FDA should not prescribe a specific format but allow individual companies to provide information as best applies to the organization. Electronic submission should be acceptable provided authenticity and confidentiality can be assured. Paper submission should also be considered as an option. Assigning a registration number should be done immediately once the initial wave of registration occurs. A computer-generated number should be automatic once the registration is submitted. Imported food from an unregistered foreign facility should be held under conditions that maintain the product’s marketability. This is particularly critical for fresh fruits and vegetables as well as other perishable foods. Once a registration is submitted on that facility, a number should be assigned immediately and the product should be allowed to move forward. Business offices of registrants where food is not held or processed should not be listed for registration. Food categories are not necessary registration information. To use the congressional record on this point – any identification of food categories shall be required only if the effectiveness of the registration system would be significantly enhanced without undue burden. Listing categories would be burdensome to the industry and does not provide the agency with information that benefits the purpose of the registration. Changes in production, product lines, packaging, and even establishment names occur regularly. It should not be necessary to re-register for many of these changes. A new registration number should not be necessary because of these regularly occurring changes. FDA should complete the rule-making on registration prior to the 18-month legislative requirement. If regulations are not made effective by that date, entities would be required to register in any event, but would need to amend registrations to comply with a final rule when made effective. Companies should be provided sufficient time to prepare registrations. Adjusting registrations based on a late released final rule would be burdensome to the food industry and the agency. 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 -25