The Distant Sound of Drumming

by Shari L. Plimpton, Ph.D.
April 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 and/or tomatoes. The Food and Drug Administration (FDA) has issued two letters of concern addressed to the fresh produce industry (Feb.2004 and Nov.,2005), an "Action Plan to Minimize Foodborne Illness in Fresh Produce…" (2004) and most recently, a draft guide for Industry to minimize microbial food safety hazards for fresh-cut fruits and vegetables (March, 2006). All of 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 Hepatitis A virus. The FDA then proceeds to let you know what information is available to address the problem, their expectation that some action is required on the part of industry and they finish with a warning regarding their legal jurisdiction in these matters.

Based on their concerns, the Feb., 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 (GAPs) and Good Manufacturing Practices (GMPs) 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 (IFT) 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 § 402(a)(4) of the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 342(a)(4)). 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, Ph.D. Director, Office of Plant and Dairy Foods, Center for Food Safety and Applied Nutrition, FDA, 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 of 2005. The second letter was addressed to California lettuce and spinach growers, packers, processors and shippers of fresh and fresh-cut lettuce and spinach and signed by the Director for the Center for Food Safety and Applied Nutrition of the FDA, Robert E. Brackett, Ph.D. 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 focuses on the issue of produce being contaminated by floodwaters without equivocation. Dr. Brackett writes, "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 notes 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. They quite poignantly state that they have 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 them. 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 http://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.

Consultation for GAPs, developing food safety programs, and passing third party audits is available through CIFT. You can reach us by calling Shari L. Plimpton at 614-314-4627 or emailing us at foodsafety@eisc.org.

Good Agricultural Practices Articles...

• ABCs of GAPs

• Cleanliness is Next to Food Safety

• The Distant Sound of Drumming

• The Efficient Use of Chlorine and Other Sanitizers in Postharvest Fruit and Vegetable Operations

• The Elements of Produce Food Safety Programs

• GAPs in Organics: Fresh Produce Safety from Pre-planting through Production

• Handling Your Food Safety Risks

• Its Not All in the Bag

• Passing a Third Party Food Safety Audit

• Pest Patrol for Fruit and Vegetable Growers

• Planning for Prevention: Fresh Produce Safety from Pre-planting through Production

• So, Just How Clean is Your Water

• Sustaining Healthy Soil

• The Value of a Food Safety Plan

• Water, Water Everywhere

• Worker Hygiene Keeps Produce Clean