Can industry experts help FDA? They couldn't hurt....
Here is a new comment on the federal docket from PMA - found at www.regulations.gov – that provides industry input on the subject of FDA transparency. From PMA and Kathy Means, some selected excerpts:
July 29, 2009
To: U.S. Food and Drug Administration
From: Produce Marketing Association, Kathy Means, Vice President of Government Relations and Public Affairs
Subject: Food and Drug Administration Transparency Task Force, Docket No. FDA-2009-N-0247
We offer the following comments specifically on how the agency can more quickly and accurately ad-vance its public health imperative by working more transparently with industry on produce safety. 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 and ensuring consumers have the information they need to avoid only those products that might make them sick and only for the finite time that the risk is presented.
Examples for Illustration
These examples illustrate several areas for improvement in transparency that would speed investiga-tions, better inform consumers and minimize impact on industry. One area is limiting the scope of the investigation as quickly as possible to specific products from specific places. Another is better communication to consumers to give them more specific information upon which to act to minimize their risk of becoming ill and specific information about resuming consumption of a product when the risk is past. Yet another is improved information validation and sharing among the agency, state/local agencies and industry.
During these 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 dis-tance, yet we believe that finding a way to work more closely together is essential to protecting public health. We regularly communicate with FDA on matters of common interest – Good Agricultural Practices, Third Party Certification, fresh-cut produce guidance, the Produce Safety Action Plan, Reportable Food Registry and more. We want to expand that to a greater, faster, and immediately productive give-and-take dialogue on foodborne illness outbreaks linked to fresh produce.
We recommend establishing a structure within which FDA can use industry experts – individually and as a team – to learn more about the industry’s practices. (We also recommend that these experts work with the Centers for Disease Control and Prevention as they work with state and local agencies to identify the suspect food item(s).
We have discussed this with CDC, but that falls outside the scope of these comments. 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/terminology, supply-chain 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. In the spinach example, FDA would already have known the main sources and varieties of spinach available at the time and would have understood that many production areas (e.g. Colorado, Michigan, New Jersey, New York) could not have been involved in the outbreak because they would not have been shipping at the time. They also would have known that other varieties of spinach – not associated with the outbreak – could be safe to move in commerce.
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.
For example, in the case of the pepper outbreak originally linked to tomatoes, had they known the location of the illnesses (where people got sick, not where they lived), industry experts could have identified to FDA the likely sources of product and distributors involved in those areas. This would have helped to focus the investigation more quickly.
They also could have identified which areas were shipping and those that were not shipping at the time of the illnesses, including any unique factors (e.g. one area beginning its shipping season earlier than usual because of weather anomalies). The FDA commissioner at the time of the pepper (tomato) outbreak invited industry representatives to meet with FDA staff in July 2008 to allow him to hear individual views on the possible explanations for the then-current Salmonella outbreak. He also sought individual ideas about alternate lines of investigation that could help the agency.
CDC called the outbreak the most complex food illness outbreak it had ever seen. The meeting, attended by all senior FDA staff, as well as one senior CDC representative, included six produce, retail, and restaurant association representatives and senior officials and quality assurance experts from the produce industry and from large supermarkets and restaurant chains.
We stressed that we could help FDA better if we had more detailed epidemiological information and more details on what the investigation had or had not shown at that time. Almost every industry leader stressed the need for the federal agencies to reach out to industry earlier for help in analyzing and explaining the data.
We do not seek individual patient information; rather we seek information about illness distribution and points of consumption. Industry explained that with greater information about demographics/ethnicity of ill persons as well as details on the types of outlets where they were exposed (e.g. chain restaurants vs. mom-and-pop restaurants, cuisine of restaurants), industry could help FDA by identifying products, distribution patterns, and pertinent anomalies.
In this one meeting, industry identified potential areas of investigation, including production methods; cross-contamination by various inputs; potential issues with transportation, labor, and distribution methods and patterns. Industry presented many ideas on paths FDA could pursue, offered assistance in sampling and testing, and offered expert panels to help FDA with this and other outbreaks.
FDA raised its legal constraints – being able to speak with individuals (“wise persons”) but not to groups, as such groups could fall into the category of advisory (or other) committees, triggering specific rules. 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. Specifically, we believe FDA must have the ability to meet with appropriate expert industry members – individually and in groups – to gather information it needs to speed investigations to protect public health. There should be regular meetings during calm times, and as-needed “war-room” type meetings during outbreaks.
We recommend that the panels be commodity-based and that the first panels established be for those commodities that FDA has identified as more likely to be associated with foodborne illness outbreaks. During calm times, these panels will help FDA understand typical sources, production me-thods/terminology, supply-chain distribution patterns/methods and unique attributes (e.g. particular cuisine uses). During an outbreak, the panel would review any anomalies to the normal patterns (e.g. shifts in sourcing due to production anomalies such as unusual weather).
FDA’s inability to do communicate with industry can delay the agency’s investigations, further putting public health at risk. We urge FDA to advise Congress on any restrictions that impede such communica-tions.
It was clear during the meeting that industry had a great deal of expertise to offer FDA to help with the agency’s investigation. It was also clear that discussions with several industry experts present at the same time contributed to greater and richer input as well as time savings – having everyone in the same room answering the same questions at the same time, each building on the contributions of others. The synergy of having industry members from throughout the supply chain was evident.
TK: It remains to be seen if the FDA can lower their guard and become a more efficient communicator with the industry during the next outbreak investigation. I would say the agency has come quite a long way already, and the addition of Jim Gorny should help even further.