August 22, 2012

How FDA Can Improve the Safety of Fruits and Vegetables

Kevin Fain

Kevin Fain

Doctoral Fellow

Center for a Livable Future

Early in 2011, President Obama signed a mandate for the FDA to better protect the nation’s food supply. Fruits and vegetables are some of the foods in need of protection—but the agency has yet to publish a regulation for how to make good on that mandate for produce safety. So what are the best ways to protect fruits and vegetables grown on farms? In the attached memorandum to FDA, CLF has outlined some specific steps for controlling threats to produce from animal waste, which would be a step forward in improving food safety. We’re hoping that the agency will listen.

The mandate I’m referring to is the Food Safety Modernization Act (FSMA), which was signed into law by President Obama in January 2011. The FSMA is a recognition by Congress that there are serious public health threats from foodborne illnesses, including newer threats from pathogens in fruits and vegetables. The law provided FDA with additional regulatory tools for protecting the nation’s food supply.  CLF submitted to FDA today the attached letter and memorandum requesting that FDA include specific steps in the produce safety regulation for animal waste controls on produce farms. CLF will follow up in the coming months to encourage the agency to adopt our recommendations.

In recent years, an increasing number of people have become sick from fruits and vegetables contaminated with bacterial and viral pathogens. And where do these pathogens in produce come from? In many cases, from animal waste stored on or near produce farms and used as produce fertilizer.

For hundreds of years, farmers have used animal manure as fertilizer for food crops.  These practices allowed for natural recycling of waste on the farm.  But our food systems have changed dramatically in the last 50 years. We are now raising significantly more animals today on fewer farms in relatively concentrated geographic regions, leading to the accumulation of enormous volumes of animal waste in agricultural communities.  The Department of Agriculture estimates that we produce 335 million tons of animal waste per year – more than a ton of animal waste for each US citizen, each year! For additional context, all people in the US generate only a total of 7.6 million tons waste each year. Animal manure contains numerous bacteria and viruses that are detrimental to human health, as well as heavy metals, antibiotic residues, and other contaminants from industrial animal production practices.  Most troubling, as the attached memorandum explains, recent science shows that under current farm practices for manure use, the pathogens are readily transferred to produce through multiple pathways, including water used for irrigation and fertilizer used on soil.  For recent disease outbreaks caused by produce contamination, FDA’s investigations have noted safety threats from the farms’ animal manure storage and handling practices.

To FDA’s credit, the agency understood and acted upon pathogen threats to produce in a 1998 guidance document, which recommends various steps farmers can take to protect their crops from contamination, including from animal waste. These steps were not requirements, though, and unfortunately the disease outbreaks from produce contamination during the last decade have reinforced the need for mandatory controls.  The guidance also recommended certain steps that we now know are inadequate for pathogen threats and did not address other contaminants in animal waste, such as heavy metals and antibiotic residues.  As the attached memorandum explains, CLF supports incorporating many of the guidance steps as requirements for animal waste controls on produce farms, with some modifications and additions, such as mandatory contaminant testing and maximum concentration limits for these contaminants.

During my time as an attorney at the U.S. Food and Drug Administration (FDA) litigating food safety cases, I saw first-hand the serious risks to consumers caused by food companies with poor production practices and insanitary conditions. The illnesses caused by contaminated produce create tough costs for all of us. Every day in America, there are numerous people suffering from illnesses caused by the food they have eaten.  The U.S. Centers for Disease Control and Prevention (CDC) recently released a report estimating that foodborne diseases cause 1 in 6 Americans to get sick each year, including 128,000 hospitalizations and 3,000 deaths. The elderly and children are particularly susceptible, but food illnesses can also strike healthy Americans.

In implementing the regulation, FDA will need to provide guidance to farmers on feasible ways to incorporate these new controls in their practices.   This is a particularly difficult time right now for American farmers facing a long and withering drought.  Small farms, as defined by the upcoming regulation, will be exempt from these regulatory requirements under the FSMA.  Balancing the economic costs of the required steps with the public health benefits will be important.  A recent study concluded that foodborne illness costs the nation nearly $78 billion per year in illness, mortality, and productivity losses. And the economic consequences can be devastating to produce farms implicated in serious foodborne outbreaks, as well as entire produce industries. These effects hurt all farmers and employees who are working hard to grow healthy food.

In the end, I am hoping that FDA will recognize and act upon this opportunity to modernize its regulation of produce safety threats, which can save lives and ensure better health for all Americans.

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