It's Not All in the Bag

by Shari L. Plimpton, Ph.D.
October 9, 2006

As growers respond to increasing demand for both fresh produce and convenience, they find themselves in unfamiliar territory and at risk of violating food law. What could go wrong? Consumers want more fresh produce for the obvious health benefits and growers want to provide quality fresh produce safely, economically and with convenience. Working to meet those consumer demands for safety, economy and convenience can lead a grower into considering packaging methods, such as bagging, that begin to cross the line between growing and packing fresh produce and entering into the more heavily regulated (and riskier) realm of food processing. However, simply putting the produce in a bag is not enough to call a product "processed." Crossing that line is a risk that growers need to understand regardless of whether they choose to grow under organic certification, use sustainable farming methods or follow conventional agriculture techniques.

Who can forget the most recent outbreak of E. coli O157: H7 in bagged salad with approximately 200 confirmed sick from that outbreak and at least 2 deaths? And this from a packing operation in the Salinas Valley of California, the "Salad Bowl of America" that packed both organic and conventionally grown-bagged salads. While E. coli has been detected in the suspect bagged spinach, far more testing will be done before the root cause of this outbreak is identified, if ever. Irrigation water is suspected, particularly because E. coli has been detected in the rivers and creeks that feed the irrigation canals in the Salinas Valley in the past. Even more recently, E. coli has been detected in irrigation water used for green leaf lettuce grown near Salinas prompting the FDA to issue a notice of recall of a specific brand of green leaf lettuce.

In the same notice of the green leaf recall, the FDA repeated its assertion that, "Fresh leafy greens grown and consumed in the United States are safe. Every year there are many thousands of pounds of fresh leafy greens such as lettuce and spinach grown in the United States and consumed by the public with no consequent illness." So what’s going on and what is a grower to do to minimize the risk and help prevent future outbreaks?

Well let’s start with the bacteria known as E. coli O157: H7. E. coli itself is a class and genus of bacteria that are part of the group known as coliforms and are grown and spread via human and animal intestinal tracts. The presence of coliforms in general and E. coli in particular in the water, soil, on packing surfaces, or within and without the plant is taken as a strong indicator that there has been fecal contamination. Growers, when testing water should be testing for Total coliforms and E. coli specifically. E. coli O157:H7 as a specific strain is of great concern because of its intense impact on human health. E. coli O157:H7 will, with relatively low numbers of infecting cells, cause gastrointestinal illness and potentially lead to a form of kidney failure known as HUS which can result in kidney damage and potentially death. Infants, and young children, the elderly, and others with compromised immune systems are particularly vulnerable to this type of infection.

In previous articles both for this publication and others (information on obtaining copies of previous articles is given below), I have described the steps necessary to develop food safety programs for fresh produce. The purpose of these programs is to prevent contamination from E. coli and other pathogenic microorganisms. We don’t have room to repeat everything in this article so I will emphasize the main points:

• Look at your entire operation from the land to the final storage and transportation with an eye out for potential contamination.

• Monitor Water Quality for irrigation, sprays, washing and related packing activities for potential pathogens. Use potable water and a sanitizer in all wash water.

• Train for and strongly encourage worker hygiene including hand washing in the field as well as after harvest.

• Provide adequate and clean sanitary facilities including access to potable water, soap and disposable towels for handwashing.

• Manage manure by composting and timing applications under accepted practices for the GAPs (Good Agricultural Practices) program.

• Exclude animals (both domestic and wild), pests, and vermin from your fields, packing facilities, storage and transportation as much as is practicable.

All of this and more GAPs are part of reducing the risk of foodborne illness for fresh produce. And at this time, none of these practices are required by regulation, but are recommended by the FDA and supported by the USDA to avoid crossing the line into regulation by selling fresh produce that is considered "adulterated." Finding that a food has become adulterated (that is contaminated in a way that is injurious to human health) gives the FDA jurisdiction to investigate in cooperation with the CDC, State and local authorities. Under the suspicion of adulteration the FDA can then recommend a recall, and can potentially work to file charges resulting in the issuance of warrants and potential seizure of the suspected food. So, it would appear that other than weights and measures, EPA regulations, Labor Laws, and potential requirements for local or state inspections, the only other regulatory concern for the fresh produce grower is to avoid adulteration.

Many growers in their efforts to improve the convenience of fresh produce (an attempt that may seem excessive for those of us who already consider fresh produce pretty convenient) will consider different types of bags, trays and other packaging methods. Bags and trays in and of themselves do not enter regulatory territory unless they become a source of contamination. Crossing the line from FDA and State recommended practices into FDA and State regulated food processing occurs when the cutting and trimming of fresh produce goes beyond the point of simply removing dead leaves and similar debris. Food processing occurs when cutting, peeling or tearing of the edible portion of the plant in any way results in the plant tissue becoming more vulnerable to bacterial infection and growth. Crossing that line results in the requirement for registering the facility, following FDA’s Good Manufacturing Practices, establishing washing and packing operations that are both sanitary and capable of yielding an unadulterated food product, State or local inspections, regulatory requirements for a Food Safety Program (preferably HAACP based), and often operating in a certified processing facility or kitchen.

Examples of practices, which keep the product in the category of fresh produce, are:

Trimming the silk and stem and/or removing outer leaves and silk;

• Washing and waxing apples;

• Trimming off dead leaves or stems from celery stalks;

• Trimming the greens off the tops of carrots, and removing roots during cleaning;

• And, removing dead or damaged outer leaves of cabbage or heads of lettuce.

Examples of practices that are considered within the realm of food processing and therefore under higher regulatory standards for good manufacturing practices are:

• Slicing apples;

• Separating and trimming the celery stalks;

• Trimming or peeling the carrots resulting in exposed carrot flesh; and

• Coring, and/or separating and cutting the leaves from cabbage or leafy greens.

The key to all practices that result in the requirement to adhere to State and FDA food processing regulations, is the increased risk of pathogen contamination and growth. It is not simply the act of putting produce in a bag or tray. Bacteria that cause foodborne illness like nothing better then a warm, moist environment with lots of open, damaged fruit or vegetable cells to grow on. And simply cooling the product is not enough to prevent foodborne illness. These bacteria are adaptable and can survive cold temperatures, ready to commence growth and increase foodborne illness risks once the packaged produce has left the grower’s control. That’s why operations that produce bagged salads of all types are regulated as food manufacturing facilities registered, certified, and inspected as required by law. We have also developed the expectation that these operations provide a step or steps in their sanitary food processing operation that will not only prevent contamination during the process, but also, reduce the number of potential contaminants in the bagged product prior to or during packing.

Selling produce through a farm or farmers’ market presents the same type of regulatory expectations, although different agencies and regulations can become involved depending on whether the produce is processed on site in some way, or packaged on the farm and then sold through the market. Simply put, if it involves trimming and cutting of the edible portion, and packaging in the packing facility, it will always be considered processed food and falls under the FDA and related State regulations. If the produce is cut and trimmed at the market and sold as food for immediate consumption, then the local and state authorities exercise jurisdiction under the food service laws and regulations for that state which often include kitchen certification and person-in-charge training requirements.

Hopefully, you get a better idea of when a food is considered fresh produce and when it becomes a processed food product as defined by the FDA. If you have any doubt about where your produce stands, please contact your local and state authorities to get their input on what you are required to do based on your operation’s practices. Far better that they help you operate within the arena of fresh produce then to find out that you are expected to recall your product and close your facility because you are in fact creating a processed food and have failed to follow regulatory requirements including the requirement to register you packaging facility.

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