2004N-0258 - Produce Safety from Production of Consumption: An Action Plan to Minimize Foodbourne Illness Associated with Fresh Produce; Public Meeting
FDA Comment Number : EC8
Submitter : Mr. Lee Frankel Date & Time: 07/28/2004 11:07:49
Organization : Fresh Produce Association of the Americas
Food Association
Category :
Issue Areas/Comments
Re: Comments on Behalf of the Fresh Produce Association of the Americas: Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce

Dear Sir or Madam:

FPAA shares, along with the private and public sectors both domestically and abroad, the common goal of improving food safety and reducing foodborne illness. We appreciate the work that FDA has done in setting out the Objectives of the Proposed Action Plan and would like to state a few areas of emphasis and enhancement.

Objective 1: Prevent Contamination of Fresh Produce With Pathogens

? We would suggest that there is a need for the development of meaningful process guides for specific steps of the production and handling chain, not just commodity specific guides. For instance, it would be useful to create similar guidance documents for packinghouse wash water similar to the guidance on Microbial Testing of Spent Irrigation Water During Sprout Production Guidance issued by FDA.

Objective 2: Minimize the Public Health Impact When Contamination of Fresh Produce Occurs

? FDA and others on epidemiology teams must visit with industry to better understand what records are kept and how they are kept. Record keeping requirements in bioterrorism legislation may have limited legal applicability; therefore, direct knowledge of records already kept for DHS and USDA should be part of training for FDA and CDC, at a minimum.

? FDA must learn to leverage other existing legal authorities such as the Perishable Agricultural Commodities and the Customs Modernization Act to help ensure the accuracy of records being used during traceback investigations.

? We would suggest that PulseNet and FoodNet should focus on better defining circumstances and sources of their findings as a basic first step before expanding the number of sites. For instance, one population group in the PulseNet system is defined as "U.S.-Mexico border region and travelers returning from Mexico." This definition includes nearly half of the U.S. and Mexican fruit and vegetable production zones and the majority of employees in the production, packing, and preparation of fresh fruits and vegetables. More precise definitions may help the effectiveness of the databases moving into the future.

? We would also suggest that FDA work with organizations such as the U.S-Mexico Binational Health Commission to better understand the health implications of current U.S. immigration policy as it affects food production workers in the United States.

Objective 3: Improve Communications with Producers, Preparers and Consumers about Fresh Produce

? We would also suggest that assistance to better educate food service and consumers regarding preparation practices for fresh produce must be part of the Action Plan. For example, beef and poultry handling instructions included with the product at retail was likely more effective than producer and slaughterhouse changes at reducing total foodborne illness related to consumption of meats.

Objective 4: Facilitate and Support Research Relevant to Fresh Produce

? FDA must not only support in theory but also fund practical projects to secure the safety and integrity of the supply of fresh produce. For example, the proposed FPAA study to "Reduce Risk by Narrowing the Windows-of-Opportunity for Biological Attacks of Fresh Produce? should be taken under serious consideration and funded. This study would test existing technologies to determine the best approach for industry to guard against biological attacks.

? Finally, given that microbial testing will be a tool used by the agency and the industry, FDA should accelerate the process of developing faster and more reliable methods. FDA should also accelerate the implementation of existing methods not yet adopted by FDA.

1a. What concepts or underlying principles should guide the 2004 Produce Safety Action Plan?
As you are aware, FPAA has worked closely in the past with FDA on GAPs issues pertaining to cantaloupe, and we look forward to continuing to work with you on this broader initiative. In the context of the cantaloupe review, we have discussed our suggestions on traceback issues, but would like to repeat those suggestions here. We believe that an FDA and CDC visit to several commercial operations would allow epidemiologists and investigators to see first hand the variety of commercial records that are currently maintained as a standard practice. The lack of familiarity with these records has limited the effectiveness of some historic trace back, and training of these systems would definitely improve future trace back investigations.

Further, with regard to traceback, FPAA suggests that the Perishable Agricultural Commodities Act offices of USDA have experts with extensive expertise on the requirements of commercial agents for U.S. importers of fresh produce that identifies the origin and disposition of virtually all fresh produce by lot number that would assist the FDA.

FPAA also suggests that, with regard to Mexico, the FDA and CDC staff take into account the immigration pathways and their conditions used by immigrant workers as a factor when developing the final action plan. These migrants form the significant portion of the labor force used by U.S. food producers, packers, and food service entities. Only through a direct visit to observe the immigration process can the FDA and CDC fully appreciate the risks associated with these migration patterns and the training challenges facing the U.S. food industry. An additional potential result of the visit would also include the possibility that the CDC would understand the heterogeneity of the U.S.-Mexico border region and consider using more detailed annotations in their virus and bacteria databases to distinguish between the various border regions when possible and appropriate. The FPAA is happy to assist in the coordination of this event with the Department of Homeland Security and the relevant U.S. and Mexican Consulates.

We believe that if the above suggestions are taken into account, the resulting final action plan will be more complete, effective and meaningful.


Lee Frankel
Fresh Produce Association of the Americas