INDUSTRY VIEWPOINT: The distant sound of drumming
- by Shari Plimpton | April 17, 2006
Growers, packers, processors and shippers of fresh and fresh-cut produce should be hearing the distant sound of drumming from the mighty jungle that is our nation's capital.
Those aren't celebratory drums you are hearing either, particularly if your business includes lettuce, spinach or tomatoes. The Food & Drug Administration has issued two letters of concern addressed to the fresh produce industry (February 2004 and November 2005), an Action Plan to Minimize Foodborne Illness in Fresh Produce (2004) and most recently, a draft guide for the industry to minimize microbial food-safety hazards for fresh-cut fruits and vegetables (March 2006).
All this activity and attention from the FDA can mean only one thing: If you haven't already done so, it is time to work on evaluating your practices for potential food-safety hazards, modify your operation to minimize those hazards -- and fast.
The first letter of concern from the FDA was addressed to growers, packers and shippers of fresh lettuce and fresh tomatoes and focused on 14 outbreaks of foodborne illness caused by Salmonella, E. coli O157:H7, Cyclospora and the hepatitis A virus. The FDA then proceeded to let the industry know what information is available to address the problem, its expectation that some action is required on the part of industry and, finally, it issued a warning regarding its legal jurisdiction in these matters.
Based on their concerns, the February 2004 letter directs growers to refer to the 1998 Guide to Minimize Microbial Food Safety Hazards for Fruits and Vegetables for an overview of Good Agricultural Practices and Good Manufacturing Practices recommended by the FDA. The letter also directs your attention to a 2001 report Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut Produce, available at http://www.cfsan.fda.gov/ ~comm/ift3-toc.html. This collaborative report between the FDA and the Institute of Food Technologists summarizes then "current scientific research relating to the various methods of eliminating or reducing pathogens, while maintaining fresh attributes, on whole and fresh-cut produce."
However, understanding GAPs and GMPs by using the FDA guide and related USDA materials is a bit easier than trying to read through the FDA/IFT 2001 report.
Finally, that first letter finishes with the following warning: "As you are aware, food produced under unsanitary conditions whereby it may be rendered injurious to health is adulterated under the Federal Food, Drug & Cosmetic Act. FDA will consider enforcement actions against firms and farms that grow or pack fresh produce under such unsanitary conditions."
Take note of this warning, regardless of whether you grow, pack, ship or distribute tomatoes or lettuce. This letter, signed by Terry C. Troxell, director of the Office of Plant & Dairy Foods of FDA's Center for Food Safety & Applied Nutrition, clearly sends the message to the entire fresh produce industry that the FDA has taken notice and is going to expect action from the industry to minimize this problem.
A second letter of "serious concern" followed the first this past November. The second letter was addressed to California lettuce and spinach growers, packers, processors and shippers of fresh and fresh-cut lettuce and spinach, and was signed by Robert E. Brackett, director for the Center for Food Safety & Applied Nutrition of the FDA. Citing the previous letter and the resources it referenced, the second letter focused on reiterating the FDA's concerns and to "strongly encourage" the industry to focus on reviewing the practices in their operations that could lead to microbial contamination and to implement modifications from the farm through distribution.
The November 2005 letter also focused on the issue of produce being contaminated by floodwaters without equivocation. Dr. Brackett wrote, "Although it is unlikely that contamination in all 19 outbreaks was caused by flooding from agricultural water sources, we would like to take this opportunity to clarify that FDA considers ready- to-eat crops (such as lettuce) that have been in contact with flood waters to be adulterated due to potential exposure to sewage, animal waste, heavy metals, pathogenic microorganisms or other contaminants." And he noted that adulterated food is subject to seizure by the FDA.
And it doesn't stop there. The FDA is apparently beginning to lose its patience with efforts to work with industry on this problem. It quite poignantly stated that it has been attempting to work with everyone on this issue since 1998, and that the stance taken by some in the industry that the exact nature of the problem must be known before anyone should take action is not acceptable to FDA. Therefore, specifically in California, yet intended for the entire industry, the FDA is asking for industry cooperation in the following areas: communication, guidance, outreach and research. It would be unwise at this point to simply hope that this will go away.
My recommendations for those who aren't in California is to learn as much as you can about GAPs, review your own operation for potential contamination, modify your operation based on what you determine, and document your food-safety policies and procedures in a food-safety plan. Another potential resource for this is the FDA's 2004 Action Plan at http://www.cfsan.fda.gov/~dms/prodpla2.html. This document reviews many of the same recommendations given in all GAPs programs and it gives an update on the FDA's most recent views on safe practices and their implementation.
Also, take the time to look at the March 2006 draft Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables(www.cfsan.fda.gov/guidance.html) and send comments while the door is open (through April 2006). You may not do any cutting; however, the FDA is asking fresh produce growers to look at this document, too. Anything that gets by without comment is assumed to be accepted by all. Your comments on this draft guide are part of what the FDA means when it says it is looking for communication.
And for Indiana and Ohio fruit and vegetable producers who could use a little help with all of this, feel free to contact us at the Ohio & Indiana Specialty Crop Food Safety Initiative by calling Mid American Ag and Hort Services at 614/246-8286 or e-mailing us at email@example.com. We are funded by the United States Department of Agriculture's Risk Management Agency to provide free materials regarding GAPs, as well as free on-farm consultations through September 2006. Visit us at the MAAHS web site at www.midamservices.org and select "Projects" from the list on the left side of the page.
(Shari L. Plimpton is a food safety educator for the Ohio and Indiana Specialty Crop Food Safety Initiative.)