FDA Announces a Public Meeting to Discuss Development of New Produce Safety Action Plan

FDA has announced a public meeting to elicit information from stakeholders concerning key elements of FDA's new produce safety proposed action plan entitled "Produce Safety From Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated With Fresh Produce." The Action Plan builds on earlier efforts such as the development and implementation of the 1998 GAPs/GMPs guidance, as well as inspections of farms and packing facilities, and investigations of foodborne illness outbreaks. It addresses all major points between the farm and the table where contamination of produce could occur, and covers fresh fruit and vegetables in their unpeeled natural form and raw minimally processed products, i.e., fresh-cut produce. The Action Plan provides significant opportunities for other U.S. government agencies at the federal, state, and local levels; foreign government agencies; industry; and the general public to participate in its development and implementation. It is posted at http://www.foodsafety.gov/~dms/prodplan.html. The public meeting will be held in College Park, MD, on Tuesday, June 29, 2004, from 1 p.m. to 4 p.m.

The public meeting solicits comments on specific issues including:

• What concepts or underlying principles should guide FDA's proposed Action Plan?
• What major practices contribute to the contamination of fresh produce by harmful pathogens?
• What intervention strategies will prevent, reduce, or control this contamination?
• Which foods should the plan cover?
• What measurements should be used to evaluate progress?
• Does FDA's current GAPS/GMPS guidance (http://www.foodsafety.gov/~dms/prodguid.html) need to be expanded or otherwise revised?
• Should the produce action plan be structured to take into account different interventions for different segments of the fresh produce industry?
• What are the roles of government agencies and the food industry?
• Are there existing food safety systems or standards that should be considered as part of the plan?

Additional information about registration for the public meeting is at http://www.cfsan.fda.gov/~lrd/fr040615.html. In addition to participating at the public meeting, you may submit written or electronic comments to Docket No. 2004N-0258 until July 24, 2004.

FDA Announces Revised Compliance Policy Guide on Prior Notice of Imported Food

FDA has revised its Compliance Policy Guide (CPG) for the Prior Notice interim final rule, originally issued in December 2003, under which we will exercise our enforcement discretion for non-commercial shipments with a non-commercial shipper, irrespective of the type of carrier. The CPG explains that a "non-commercial purpose" generally exists when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (i.e., the individual delivers the food to a post office, courier, or common carrier for delivery to self, family member, or friend for non-business purposes, i.e., not for sale, resale, barter, business use, or commercial use).

With respect to these food imports, FDA intends to focus its efforts on education from now through March 2005 (or shortly thereafter, depending on the date of issuance of the final rule).

Examples of foods imported or offered for import that may be covered by this non-commercial category are:

• food in household goods, including military, civilian, governmental agency, and diplomatic transfers;
• food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler; and
• gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment.

This has been an area of continuous significant inquiry from foreign government mail services, other government agencies, and individuals. The revised CPG is posted at: http://www.cfsan.fda.gov/~pn/cpgpn2.html. Translated versions will be posted at a later date.

FDA Announces Public Meetings on Good Manufacturing Procedures (GMPs)

FDA has scheduled two public meetings intended to obtain comments about FDA's current good manufacturing procedures (GMPs) in manufacturing, packing, or holding human food regulations. FDA believes that these comments may be useful in determining appropriate revisions to the GMP regulations.

The first meeting will be held in College Park, MD, on July 19, 2004. This meeting was originally planned for June 11, 2004; however, the previous meeting was cancelled as a result of an Executive order closing all executive departments of the Federal Government on that day, as a mark of respect for former President Ronald Reagan.

The second public meeting is scheduled for July 21, 2004, in Chicago, IL.

The complete Federal Register notice announcing the current dates for these public meetings is on FDA's website at http://www.cfsan.fda.gov/~lrd/fr040614.html. The original May 21, 2004, Federal Register notice for the meetings is online at http://www.cfsan.fda.gov/~lrd/fr040521.html., and it includes information about how to register for the meetings, how to request an opportunity to make oral comments at a meeting, and how to submit written comments, as well as a set of questions to help focus oral and written comments to FDA.

Food Safety and Security Staff E-mail:

Office Number: (301) 436-2277· FAX (301) 436-2605 CFSAN Web site: http://www.cfsan.fda.gov/