November 21, 2013
President Obama signed the Food Safety Modernization Act (FSMA) into law in January 2011, which provided the FDA with additional regulatory tools to protect the nation’s food supply. Fruits and vegetables are some of the foods in need of protection, and the agency published a proposed rule earlier this year that would require farms to adopt new practices for growing produce. CLF appreciates FDA’s significant work in developing the rule, but we also have important concerns with its content.
Problems with the proposed rule
The FSMA is a recognition by Congress that produce can be a major contributor to foodborne illness. In recent years, an increasing number of people have become sick from fruits and vegetables contaminated with bacterial and viral pathogens. And where do pathogens in produce come from? In many cases, from animal waste generated and stored at animal production facilities and used as fertilizer on produce fields.
Unfortunately, the rule fails to place any regulatory responsibility on the animal production facilities that generate contaminated animal manure—and thereby threaten to contaminate produce grown on other farms. Instead, the entire burden of mitigating these contamination threats falls on produce farms, which would be fully liable under the rule for risks caused by others. The rule would also adversely impact local and regional farming systems and those farms with sustainable production practices. CLF has submitted a formal comment to FDA and recommended specific changes to the rule to address these oversights, which we believe will help ensure the safety of our food supply and health of all Americans. We’re hoping that the agency will agree.
Why we must enhance food safety and protect sustainable food systems
Protecting the nation’s food supply and promoting local and regional food systems and sustainable farming practices are critical for our health. The U.S. Centers for Disease Control and Prevention (CDC) released a report estimating that foodborne diseases cause 1 in 6 Americans to get sick each year, and are responsible for 128,000 hospitalizations and 3,000 deaths. The elderly and children are particularly susceptible, but foodborne illnesses can also strike healthy Americans. Millions of Americans also suffer from diet-related chronic illnesses, such as heart disease, diabetes, and cancer. Local and regional food systems are critical to provide healthy, fresh food to our citizens. Sustainable farming practices are also important for food safety and maintaining a healthy diet.
Threats to produce safety from animal production facilities
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 in fewer facilities in relatively concentrated geographic regions, leading to the accumulation of enormous volumes of animal waste in agricultural communities. The U.S. Department of Agriculture estimates that we produce 335 million tons of animal waste per year – more than a ton of animal waste for each U.S. citizen, each year. For additional context, all people in the U.S. generate only a total of 7.6 million tons of 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 CLF comment explains, recent science shows that pathogens are readily transferred from these animal production facilities to produce grown on farms 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 animal manure.
FDA must shift regulatory responsibility to root causes
FDA’s proposed rule would require produce farms to identify and control these threats from animal production facilities, including through agricultural water monitoring, testing, and treatment, as well as mandatory steps in order to use animal manure as fertilizer. This sole focus on produce farms, however, is misplaced. We explain in our comment that the rule should instead shift this regulatory responsibility “upstream” to those animal production facilities that are responsible for contaminating produce through environmental pathways and manure used as fertilizer.
This regulatory approach would be much more efficient and effective. Animal production facilities are in a much better position to control those risks from their practices that threaten produce. It is simply unfair to require produce farms to mitigate threats from animal manure that are caused by other responsible parties.
For these scientific and policy reasons, we have requested in our comment that FDA issue a separate rule to regulate animal production facilities with manure practices that threaten produce farms. Importantly, our comment provides detailed justification for FDA’s legal authority under FSMA to regulate these animal production facility practices that endanger produce safety. Congress did not intend for produce farms to be responsible for risks to fruits and vegetables that are caused by others.
The proposed rule changes requested by CLF are critical for public health
During my time as an attorney at the FDA litigating food safety cases, I saw first-hand the serious risks to consumers caused by food companies with poor production practices and unsanitary conditions. The practices by animal production facilities that create significant risks for produce safety can jeopardize public health if they result in foodborne outbreaks. 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.
During my recent time as a CLF-Lerner fellow and doctoral student in epidemiology, I have also grown to realize the importance of fostering our local and regional food systems and encouraging sustainable farm practices. The CLF course on food production systems and public health was particularly helpful, as well as visits to Clagett Farm and other places that are growing and distributing healthy food locally and producing it in sustainable ways. Some of these farms, though, would not be able to comply with all of the proposed rule’s requirements. We explain in the comment that FDA should provide some regulatory flexibility for these farms in order to protect these important local and regional food systems and sustainable farm practices. In this way FDA can enhance food safety and these food systems that are critical for public health.
In the end, I am hoping that FDA will recognize the importance of addressing the root cause of many food safety issues, as well as the importance of taking a systems approach to food safety regulation. Taking up actions suggested in the CLF comment would be a good first step. By regulating produce safety threats in this way, the FDA can save lives and ensure better health for all Americans.