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
July 29, 2009
To: U.S. Food and Drug
From: Produce Marketing
Association, Kathy Means, Vice President of Government Relations and Public
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.
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
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.
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).
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
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
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.