Daily Rules, Proposed Rules, and Notices of the Federal Government
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In 1997, the Produce and Imported Food Safety Initiative (PIFSI) was released, which brought increased attention and resources to produce and microbial food safety. In 1998, as a part of this initiative, FDA issued guidance on good agricultural practices (GAPs) and the good manufacturing practice regulations (GMPs) for fresh produce. This guidance entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,” (1998 guidance or 1998 GAPs/GMPs guidance), is broad in scope and covers all fresh produce consumed in the United States that is produced domestically and abroad and practices commonly involved in the production and packing of fresh produce. The 1998 GAPs/GMPs guidance has been well received and widely adopted; however, foodborne illness outbreaks associated with fresh produce continue to occur.
The draft 2004 produce safety action plan continues the 1997 initiative, building on experience from earlier efforts such as the development and implementation of the 1998 GAPs/GMPs guidance, inspections of farms and produce packing facilities, and investigations of foodborne illness outbreaks. The draft of the 2004 produce action plan addresses all principal points between the farm and table where contamination of produce could occur. It covers fresh fruit and vegetables in their native form and raw, minimally processed products, i.e., raw, pre-cut, or fresh-cut fruits and vegetables that have received some processing to alter their form (such as peeling, slicing, chopping, shredding, coring, trimming, or mashing), but have not been subject to a thermal process that would reduce, control, or eliminate microbial hazards. The draft action plan is not intended to cover processed products such as juice, or agricultural products other than fruits and vegetables, such as tree nuts.
In the 7 years since PIFSI began, many changes have occurred in the industry and much new knowledge and information are available. FDA believes that a good first step in moving the produce safety action plan forward is to engage and solicit the views of other Government agencies at Federal, State, and local levels, from industry groups, and from the public generally. The public meeting and comment period are intended to provide that opportunity.
FDA has drafted the set of questions below to help focus comments presented at the public meeting or otherwise communicated to the agency.
1. What concepts or underlying principles should guide the 2004 Produce Safety Action Plan? Are the seven objectives in the working draft appropriate for achieving the overarching goal to minimize foodborne illness associated with the consumption of fresh produce?
2. What major practices contribute to the contamination of fresh produce by harmful pathogens? What intervention strategies will prevent, reduce, or control this contamination?
3. The produce action plan covers fresh fruits and vegetables that have not been heat treated to reduce, control, or eliminate pathogens, or otherwise significantly processed. The draft action plan is not intended to cover frozen fruits and vegetables, fruit and vegetable juices, or other commodities such as tree nuts that are neither fruits nor vegetables and not typically regarded as produce. Should the produce action plan cover additional foods? If so, which foods?
4. What measurements should be used to measure progress toward the overarching goal (to minimize foodborne illness associated with fresh produce consumption)? What measures should be used to measure progress toward the individual objectives?
5. Does FDA's current GAPs/GMPs guidance (
6. In today's production and food preparation environments (farms, packing houses, retail establishments, and consumers), what conditions, practices, or other factors are the principal contributors to contamination of produce with a pathogen? What interventions would reduce, control, or eliminate this contamination?
7. There is broad variation within food operations including variations in size of establishments, the nature of the commodity produced, the practices used in production, and the vulnerability of a particular commodity to microbial hazards. How, if at all, should the produce action plan be structured to take into account such variation? For example, should there be different sets of interventions for identifiable segments of the fresh produce industry?
8. What roles can and should Federal, State, and local agencies and the food industry play in developing and implementing action items to help achieve the objectives in this action plan?
9. Are there existing food safety systems or standards (such as international standards) that FDA should consider as part of the agency's development and implementation of a produce safety action plan? Please identify these systems or standards and explain what their consideration might contribute to this effort.
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In addition to presenting oral comments at the public meeting, interested persons may submit to the Division of Dockets Management (see