Kathy Means on FDA transparency


Published on 06/24/2009 01:33pm

By Tom Karst

Source of Article: 



Passed on by Julia Stewart of PMA, here are comments by Kathy Means to FDA today:

Produce Marketing Association
Comments for Food and Drug Administration Transparency Task Force
June 24, 2009

Thank you for the opportunity to address this group. I am Kathy Means, Vice President of Government Relations and Public Affairs, speaking for the Produce Marketing Association. We represent more than 3,000 companies throughout the food distribution chain that market more than 90% of fresh produce sold at the consumer level.  

Prevention of foodborne illness is a top priority for the fresh produce industry and the FDA. On the rare occasions when a foodborne illness outbreak occurs, our collective priority is to stop the spread of the outbreak, often by removing the food linked to the outbreak from the supply chain.

During recent foodborne illness outbreaks linked to fresh produce, we have discovered that closer efforts between the fresh produce industry and FDA may speed the investigations, thereby protecting public health. FDA’s ability to share information with industry will allow industry to provide valuable information back to FDA.

We understand the need for the regulator and the regulated industry to maintain an appropriate distance, yet we believe that finding a way to work more closely together is essential to protecting public health.

We recommend establishing a structure within which FDA can use industry experts – individually and/or as a team – to learn more about the industry’s practices. Using these experts would be important in two ways.

The first application is when there is no outbreak. Experts on those fresh produce commodities FDA has identified as most likely to be linked to foodborne illness outbreaks could educate FDA on the commodities, production methods, distribution patterns, and more. We might undertake mock exercises to determine whether we have the right experts and the right information, allowing us to fill in any gaps during calm times. In this way, should an outbreak occur, FDA will already be familiar with the commodity and its movement through the supply chain.

The second application would be when an outbreak occurs. These experts can help FDA determine specific product sources and distribution patterns, in addition to any unique factors that might be affecting that commodity or its distribution at that particular time.

Existing rules about interaction between the industry and FDA might have to be changed, and we would gladly work with FDA to identify opportunities to make this work.

Another area of transparency involves FDA and state or local health department coordination. We call attention to the CALFERT program in which FDA and the California Department of Health Services work together in emergencies. Not all states have equal capabilities or capacities when it comes to foodborne illness investigations. During outbreaks, as the industry seeks information to help us respond effectively, we often hear that states have not yet shared information or that the information states give to FDA cannot be shared with us. Broader information sharing will help all work swiftly toward the same goal – protecting public health.

We can all work together better to achieve our common goal when we have the necessary information. Improvements to transparency among all the health agencies are important, as is improving the capacities and capabilities of the states.

Finally, the public would benefit from improved transparency when health emergencies are over. FDA does an excellent job of reporting public health threats, such as asking consumers to avoid certain foods when a foodborne illness outbreak occurs. The public needs just as strong a communication when that threat is over. We urge FDA to include in its protocols an “all clear” procedure that will alert the public that they can resume eating a particular food when it is again safe to do so.

In conclusion, I want to stress again that we all have the same priority – protecting public health. We have seen improved efforts by FDA to gather industry information to help with its investigations. We must continue down that path and discover new ways to work together to speed and improve public health efforts.

Kathy Means, Vice President Government Relations and Public Affairs
Produce Marketing Association


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