Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Comments from the Association of Food and Drug officials on Docket No. FDA-2010-N-0085 “Preventive Controls for Fresh Produce”
The Association of Food & Drug Officials (AFDO) is a national organization that represents state, local, and federal food safety regulatory officials. AFDO is well known for promoting uniformity and cooperation among the regulatory community and for sponsoring numerous collaborative projects to advance the vision of a national integrated food safety system for this country. Among the national projects we were active in developing and promoting are the Seafood HACCP Alliance, National Food Safety System (NFSS) project, States Helping States mentoring program, and the FoodSHIELD community of regulatory programs. Additionally, AFDO has developed a host of model codes that states utilize in promulgating their own specific regulations. AFDO model codes such as our “Cured Salted and Smoked Fish GMP’s”, “Guidelines for Juice Manufacturers”, “Retail Meat & Poultry Processing at Retail Guidelines” and “Reduced Oxygen Packaging at Retail” were developed when food safety concerns associated with these issues were raised. A number of federal and state standards and regulations were developed in part from the information contained within these model codes.
Recent outbreaks associated with fresh fruits and vegetables were investigated by a number of our members and following each of these outbreaks questions were raised as to the current effectiveness of government regulatory activities in the fresh produce arena. As a result, AFDO developed a “Model Code for Produce Safety for State and Regulatory Agencies”. The Code represents the culmination of a two-year effort by a number of dedicated organizations and individuals who were asked to develop a science based regulatory framework to address the production of all fruits and vegetables, while maintaining the flexibility to appropriately address specific commodities of higher concern. It builds upon existing guidance documents and regulations; and, consistent with AFDO’s mission to promote uniform food safety laws, rules and regulations, this Model Code for Produce Safety may be viewed as another tool to assist the regulatory community in development of a nationally integrated food safety system To develop this Model Code, AFDO convened a body of state regulatory officials, representatives from FDA and USDA who were well versed in the development and implementation of Good Agricultural Practices, as well as a broad spectrum of industry participants which included individual growers, grower associations, produce marketers, the transportation industry, manufacturers/processors, retail grocers, consumer organizations, and representatives from academia. During the 22 months of deliberation, various others participated in specific discussions which affected their specific interests/organization. If FDA wishes a complete listing of participants, please refer to the Model Code or contact the AFDO office.
Further, AFDO wishes to stress that the primary task given the workgroup was to determine what minimum set of requirementsshould be applicable to all growers/packers of fresh fruits and vegetables, regardless of size or commodity. These requirements were crafted in such a way as to allow appropriate variability in implementation in order to accommodate site specific needs, issues, or risks. Similar to the seafood HACCP regulation, it is envisioned that these minimum set of requirements for fresh produce will be accompanied by commodity specific guidance documents to address particular hazards, risk mitigation technologies, growing or handling practices, etc. We believe that we can build upon prior experience and success, and we envision the formation of a Produce Alliance to address both generic and commodity specific guidance and support documents.
Finally, we wish to note that in the adoption of the AFDO Model Code, there was full consensus by the participants. While many points warranted considerable discussion or deliberation, the final document reflects complete agreement by the participants. For these reasons, AFDO strongly urges FDA to give careful consideration to the document and the level of acceptance of the principles it embodies.
AFDO is submitting this model code as part of our official comments to FDA relative to “Preventive Controls for Fresh Produce”. We believe it can serve as a beginning point in developing regulations for fresh produce. Some important factors associated with this model code are as follows:
- The model code is intended to address food safety practices for produce (fresh fruits and vegetables) at the farm and packing facility. It does not address additional processing or handling that may occur at a fresh-cut processing facility.
- In the development of this model code, AFDO adopted an approach similar to that of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation where requirements are presented in broad terms within the code, with more specific practices and options presented in a companion “hazards and controls’ guidance document.
- Developers of the model code agreed that a food safety assessment and a written food safety plan, based on the outcome of the assessment, are critical for all firms growing and packing fresh produce.
While the Model Code is focused on domestically grown and packed fresh produce, AFDO also urges that these same standards be applied to imported product. This is critical not only to ensure safety for the consumer, but also to reduce the risk of national outbreaks – which have been shown to have a devastating economic effect on all producers of the affected commodity.
AFDO appreciates the opportunity to present our “Model Code for Produce Safety” along with the comments above to FDA for consideration in the effort to establish preventive controls for fresh produce. Should you have additional questions or need clarification on any of the topics discussed herein, please do not hesitate to contact me.
Ronald S. Klein