© Bob Ferguson
FDA Hears Ways to Improve Produce Safety
The Tomato Magazine
June 2007
By Dorothy Noble
The food-borne illness outbreak associated with contaminated spinach
last fall heightened safety interest throughout the entire produce industry.
The Food and Drug Administration’s (FDA’s) recent hearings on
produce safety highlighted the need to share information and to consider
possible measures to enhance the safety of fresh produce.
Unpublished data compiled by the Centers for Disease Control and Prevention
(CDC) show that from 1996 to 2006 there were 72 reported outbreaks associated
with 20 fresh produce commodities. Of this total, 12 related to tomatoes,
11 to melons and 24 with leafy greens such as lettuce and spinach. Significantly,
the CDC noted that these outbreaks increased both in absolute numbers
and as a proportion of all reported foodborne outbreaks. These involved
a number of pathogens, including Escherichia coli (E. coli) O157:H7 and
Salmonella species, in both domestic and imported produce.
A number of produce industry, academic, scientific, government and consumer
group leaders testified at the FDA hearings. The participants noted that
although fresh produce is overwhelmingly safe, the small risks can be
minimized by assessing risk factors and establishing commodity-specific
standards.
Tom Stenzel, president and chief executive offi cer, United Fresh Produce
Association, called for strong federal government oversight. The FDA is
the agency responsible for ensuring the safety of fresh
and fresh-cut fruits and vegetables. The agency has issued voluntary industry
guidelines and a produce action plan, and has worked with the produce
industry on guidelines for melons, lettuce and leafy greens, and tomatoes;
but has not put mandatory regulations in place.
Stenzel said standards should be geographically consistent, and because
most produce commodities have never been linked to a food-borne illness,
the standards should be specific to critical commodities. Stenzel pointed
to the developments of best agricultural practices in the tomato industry
and their various means to assure compliance across multiple growing regions.
Florida Tomato Industry Leads Regulatory Effort
The Florida tomato industry, which is the largest in the U.S., supplies
about half of all tomatoes to American consumers. Reggie Brown, executive
vice president of the Florida Tomato Exchange and manager of the Florida
Tomato Commission, said the industry has been working to establish mandatory
state regulation of food safety for Florida tomatoes.
Their 3-year efforts were rewarded at the end of April when the Florida
legislature passed the bill requiring the Florida Department of Agriculture
and Consumer Services to perform food safety inspections in tomato farms,
greenhouses and packinghouses and repackers.
Brown said the proposed regulations were drawn from guidelines which included
FDA’s 1998 Guide to Minimize Microbial Food Safety Hazards for Fruits
and Vegetables and the 2006 guidelines of the North American Tomato Trade
Working Group (NATTWG), Commodity Specific Food Safety Guidelines for
the Fresh Tomato Supply Chain. As members of NATTWG, the Florida industry
has worked with other tomato groups to address food safety concerns. Brown
told The Tomato Magazine that the regulations, which include Good
Agricultural Practices (GAPs) and Best Management Practices (BMPs), address
specifi c tomato production and handling systems in Florida. At this writing,
the bill is awaiting the governor’s signature.
Several California groups, including the cooperative California Tomato
Farmers, have been devising mandates for more rigorous food safety practices
for their members. Dr. Martha Roberts, special
assistant to the director of the Florida Agricultural Experimental Station
at the University of Florida, pointed out during FDA’s April 13 hearing
that several researchers have determined that although
acidic, tomatoes can support pathogens under certain conditions. Temperature,
the presence of wounds and the stem scar can influence pathogen growth.
GAPs
Several of the FDA panelists during the hearing had questions for the
presenters. In particular, Dr. Jack Guzewich, acting director of the Division
of Public Health and Biostatistics, Office of Food Defense, Communication
and Emergency Response, Center for Food Safety and Applied Nutrition,
FDA, asked if growers understood and applied GAPs. The response was generally
positive.
In his comments, Alfred Murray, assistant secretary, New Jersey Department
of Agriculture, said their Produce Safety Task Force has been training
growers in GAPs and the third-party audit procedure. Murray also observed
a need for a system that recognizes the differences in farm operation
sizes, unique methods for growing and harvesting fruits and vegetables,
and the differences in
irrigation techniques used in his State and the region.
Need for commodity-specific uniformity Bryan Silbermann, president, Produce
Marketing Association (PMA), expressed concern over a “patchwork”
approach. Applauding California’s leafy greens marketing agreement
in which standards are enforced through the certifi cation process, Silbermann
said “PMA believes that the initiative in California needs to be
followed by a robust federal effort that is verifi able and applies to
any products grown in the U. S. or abroad. We need that to promote public
confidence and avoid a patchwork approach to an issue crying out for an
umbrella solution.
Under the umbrella we should have commodity-specific protocols based on
sound science and prioritized by risk.” Silbermann also mentioned
greater traceability as another area PMA can help enhance in order to
narrow the scope of any future outbreak.
In April, PMA committed $2 million to help launch the Center for Produce
Safety at the University of California, Davis. PMA also committed $200,000
for training growers on the best GAPs. Dr. Jim Rushing, director of the
Coastal Research and Education Center, Clemson University, urged uniformity
across states.
“Only the federal government has the capacity to broadly implement
standards,” he added, but noted the current limitations in FDA’s
funding.
Voluntary Guidelines Not Effective
In her presentation, Caroline Smith DeWaal, director of Food Safety, Center
for Science in the Public Interest, also stated that FDA lacks the resources
for food safety. Further, she said that guidelines
are ineffective, and petitioned the FDA to develop uniform standards,
require a written plan of all growers specifi c to environmental conditions
and audit the plan each season.
DeWaal also recommended that FDA publish a “Hazards and Controls
Guide” outlining hazards in different produce and the best known
controls to prevent or reduce risks. DeWaal reminded
the FDA panel that her organization is a big champion of eating more fruits
and vegetables. Sally Greenberg, senior counsel, Consumers Union, said
the voluntary approach does not work, and
commended state actions such as that undertaken by Florida. She urged
written plans, GAPs for all farms, hazard critical control point programs
for all processors, third-party audits, trace-back systems and FDA yearly
inspections with penalties for noncompliance.
FDA’s Role in Promoting Produce
Thomas A. Nassif, president and chief executive officer of the Western
Growers Association, related the speed taken by their growers and handlers
in developing the tough, uniform leafy greens safety standards in California
in response to the fall outbreak. He said that FDA has a dual mission
to both protect and promote the public health, and that the net effect
of FDA’s consumer alert in the spinach outbreak has been to promote
the non-consumption of some fresh produce.
Many consumers still believe packaged salads, even without spinach, to
be unsafe. Nassif said FDA has a responsibility to assist in restoring
confi dence in the food supply, and suggested that the agency assist the
fresh produce industry in developing and promoting the best practices
to reduce risks. He included examples such as the approval of kill steps,
the pros and cons of adapting other systems to provide national oversight
such as regulations and model codes. In addition, Nassif said FDA should
call on transportation companies, food service operations and retailers
to develop their own robust best practices to ensure food safety.
With respect to tomatoes, the Western Growers Association also favors
a commodity-specific approach, based on scientific research.
FDA will accept comments on produce safety until June 13, 2007. Direct
ove Produce Safety mail comments to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061,
Rockville, Maryland 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
Comments must include the agency name and the docket number
2007N-0051.
RESOURCES
The CDC defines an “outbreak” as the occurrence of two or more
cases of a similar illness resulting from the ingestion of a common food.
FDA’s “Guide to Minimize Microbial Food Safety Hazards for Fresh
Fruits and Vegetables,” October 26, 1998, is available at http://www.cfsan.fda.gov/~dms/prodguid.html.
FDA’s “Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut
Fruits and Vegetables,” March 2007, is available at http://www.cfsan.fda.gov/~dms/prodgui3.html.
The North American Tomato Trade Work Group’s “Commodity Specific
Food Safety Guidelines for the Fresh Tomato Supply Chain,” May 2006,
is available at http://www.cfsan.fda.gov/~dms/tomatsup.html.
Good Agricultural Practices information is available at the Cornell University’s
site, http://www.gaps.cornell.edu.
A 175-page manual and CD, authored by Rutgers University agricultural
agent Dr. Wesley L. Kline, “Developing a Plan for Third-Party Audits,
Good Agricultural Practices (GAPs),” is available for $60 prepaid,
payable to the Extension Service Programs Account, mailed to Rutgers Cooperative
Extension, 291 Morton Avenue, Millville, New Jersey 08332. Inquiries may
be directed to Helen or
Annette, telephone 856 451-2800.
The Florida tomato industry’s proposals to the Florida legislature
can be found at http://www.floridatomatoes.org under “food safety.”
© 2007 Columbia Publishing
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