In late summer 2011, Michelle Wakley went into labor three months before her due date. She had eaten a cantaloupe tainted with Listeria and fallen ill. Her newborn daughter Kendall, weighing in at just 3 pounds, 11 ounces, and suffering from a related infection, lived in an incubator for weeks and had to be fed through a stomach tube for more than a year. Kendall may face lifelong physical and mental disabilities. Michelle and Kendall were, in a sense, among the lucky ones. At least 33 people died after eating dirty cantaloupes traced back to the same company: Jensen Farms of Holly, Colorado. The outbreak also sickened 147 people in 28 different states. It was one of the most widespread outbreaks in history and followed closely on the heels of several other major food safety disasters involving contaminated produce, including separate incidents caused by tainted spinach and jalapeño peppers.
The cumulative impact of foodborne illness is difficult to measure because only the most severe cases lead to hospital visits and get reported to government agencies capable of tracking the big picture. The Centers for Disease Control (CDC)—the main and best source of information, given its role in tracking and investigating major outbreaks—estimate that foodborne disease causes 48 million illnesses each year in the United States.[i] Such widespread suffering is reason enough to demand improvements to food safety systems, but the costs to industry are also worth mentioning. Following the 2006 E. coli outbreak in bagged spinach, which sickened more than 200 people in 26 states and killed three others, researchers observed a massive decline in spinach sales across the country, resulting in millions of dollars of losses for innocent producers.[ii]
Congress passed the Food Safety Modernization Act (FSMA) in 2011 in an effort to improve food safety regulations. Under the new law, the Food and Drug Administration (FDA) was tasked with developing a host of new rules—and to accomplish the task on a short timeline. The combination of two of the rules that Congress specified—the “Produce Safety” rule and the “Preventive Controls for Human Foods” rule—will likely have the biggest impact on foodborne illness outbreaks. The preventive controls rule applies only to non-farm activities such as turning carrots into “baby carrots” or slicing and bagging apples. The Produce Safety rule identifies key farming practices (irrigation, fertilization using manure and biosolids, equipment choice, worker training) that are vulnerable to pathogenic contamination if not carried out properly.
What’s the Holdup?
The Produce Safety rule has been a long time coming. After President Obama signed the law into effect in January 2011, the FDA got to work on the required rules, completed the proposal, and sent the drafts to the White House Office of Information and Regulatory Affairs (OIRA) for review by Thanksgiving of that year. Even though such reviews are generally required to last no longer than four months, the proposals sat there in limbo for more than a year, likely victims of the 2012 elections. Following a lawsuit by public interest advocates aimed at breaking the rules free from White House review, the FDA published the Produce Safety rule for public comment in January 2013. The FDA later extended the public comment deadline three times and hastily organized a series of stakeholder meetings to hear out concerned farmers and food safety advocates. Such backpedaling not only shows a lack of confidence in the rulemaking package as it was published, but also gives opponents extra time to organize a broad base of advocates who can leverage congressional allies and the media to further delay the rulemaking process. The FDA even published a “supplemental” proposal in September 2014, which introduced significant changes to the original proposal. By the time the comment period on the supplemental NPRM closes in December 2014, the Produce Safety Rule will have been out for comment for nearly two years—far longer than usual for most other public health rules.
The farm lobby, channeling the fierce independence of many farmers and the anti-regulatory bent of Big Ag, has cloaked its objections to the Produce Safety rule largely in histrionics. Writing in Food Safety News, for instance, the owner of a seed company in California declared the Produce Safety rule (and the companion Preventive Controls and Foreign Supplier Verification regulations proposed by the FDA) to be a “War on Farmers.”[iii]
From the farm lobby’s and food safety advocates’ perspectives, the four critical issues are the types of crops and farming activities covered by the rule, available exemptions to the rule, the proposed testing standards for irrigation water, and the provisions governing the use of manure and other “biological soil amendments.”
On the water and soil front, the FDA’s goal is to ensure that the irrigation water and manure used to nurture produce do not contaminate the food supply with bacteria such as E. coli and Salmonella, the leading causes of foodborne illness. In the FDA’s estimation, the best way to do that is to test the water regularly (treating the water or delaying harvest if it is too contaminated) and to establish waiting periods between manure application and harvest.
The coverage questions are more complex. A common concern is whether a farmer should be subject to more stringent rules because she occasionally takes produce from neighbors and packages it with her own in order to meet the demands of wholesalers, restaurants, and other “mid-stream” customers. Such post-harvest activities present real risks of spreading contamination, but the FDA is reluctant to apply the same rules to small farmers as it does to major agroprocessors. Another issue is how the FDA should implement the “Tester Amendment,” which exempts certain small farmers from the rules if their total sales fall below a $500,000 per year threshold and a majority of their sales are made directly to consumers or local restaurants or other retail food establishments.
What Should the Rule Do?
The recently published supplemental proposal needs improvement. For example, with regard to the rule’s coverage, the FDA retained the exemption for food “rarely consumed raw.” That exemption allows farmers to use lax practices on such items such as kale and figs, which are frequently consumed raw.[iv] Moreover, it puts the burden on consumers to eliminate pathogens, rather than promoting good agricultural practices. The FDA should simply eliminate this exemption.
On the soil amendments issue, the agency has abandoned its proposed nine-month waiting period between raw manure application and produce harvest. Instead, the FDA proposes to conduct additional and “extensive” research to determine an appropriate risk-based waiting period. And in the meantime, the FDA has given tacit approval for farmers to utilize the waiting periods set forth in the Department of Agriculture’s National Organic Program standards. Those changes make sense. But in the final rule the FDA should also ban the use of sewage sludge in produce-farming operations covered by the rule, given the many contaminants that pass through public sewage treatment plants (e.g., PBDE flame retardants, pharmaceuticals, heavy metals, and other toxins).[v]
The FDA’s proposal strikes a fair balance on irrigation water testing, minimizing contamination risks posed by domestic and wild animals, cleaning tools and other materials, worker training, and procedures for implementing the Tester Amendment. However, recordkeeping rules could be improved by requiring farmers to keep track of which packers and processors handle their produce when those activities occur off the farm.
Update: The FDA published the final Produce Safety rule in the Federal Register in November 2015. In doing so, the agency satisfied a court-ordered deadline, which was set in response to the agency’s ongoing delays in completing the rule. The final version maintains much of what was included in the agency’s supplemental proposal. One potentially concerning change in the final rule is that the FDA appears to have weakened quality and testing standards for irrigation water that is often a source of pathogenic contamination in produce. On the plus side, the final rule eliminates some of the exemptions that the proposal contained for certain kinds of produce, including Brussels sprouts and bok choy. As with the FDA’s final rules setting Preventive Controls standards for processed human and animal foods, the success of the Produce Safety rule will largely turn on how effectively the agency is able to ensure meaningful compliance with the rule’s requirements. Given Congress’s consistent refusal to provide the FDA with adequate funding for its food safety program implementation, the agency will likely be hampered in its efforts to enforce the rule and instead will have to rely on continued industry self-policing.