New Produce Safety Regulations

A Salmonella outbreak in the United States that was linked to Mexican cucumbers killed 6 people and sickened at least 907 people in 40 states from July 2015 to February 2016. ¹ The outbreak is emblematic of greater challenges in regulating and maintaining produce safety. The Centers for Disease Control and Prevention estimates that every year in the United States approximately 48 million people get sick, 128 000 are hospitalized, and 3000 die from food-borne illnesses, meaning that food-borne illness affects approximately 1 in 6 Americans annually. ²

In addition to its public health implications, food-borne illness imposes an economic burden. A 2015 report from the US Department of Agriculture estimated that food-borne illness in the United States costs more than $15.5 billion each year; however, this report estimated only the cost of food-borne illness that could be traced to a specific pathogen. Pathogens are identified in only 20% of illnesses. ³ As such, the true economic cost of food-borne illness exceeds $15.5 billion annually.

Produce is a substantial food-borne illness threat. The Center for Science in the Public Interest studied food-borne illness outbreaks during a 10-year period and found that produce accounted for more outbreaks and a greater number of illnesses than any other single category of food. ⁴ A Centers for Disease Control and Prevention report showed that produce was implicated in 46% of food-borne illnesses. ⁵

Food Safety Modernization Act

To help address the public health challenge of food safety, in 2010 Congress passed the Food Safety Modernization Act (FSMA), which took effect in 2011. ⁶ The passage of the FSMA marked the first major overhaul of federal food safety in 70 years. This legislation revolutionized the US Food and Drug Administration’s (FDA’s) approach to food safety by emphasizing the prevention of food-borne illness rather than the reaction to food-borne illness outbreaks.

Before the FSMA, the FDA focused on responding to adulterated food that had entered interstate commerce; this response entailed removing the adulterated food and taking enforcement action against the parties that had adulterated the food or moved it through interstate commerce. Although the federal legal definition of adulterated food has several restrictions, at its heart the definition refers to food that “bears or contains any poisonous or deleterious substance which may render it injurious to health.” ⁷

Although the FDA still has this authority to respond, the FSMA tasked it with new responsibilities to prevent adulterated food from entering commerce in the first place. The FSMA required the establishment of preventive measures, such as mandatory hazard analysis and preventive controls for food production facilities, standards for sanitary food transportation, standards to prevent the intentional contamination of food, and standards for produce safety. ⁶

Challenges in Developing Produce Safety Regulations

The FSMA required the FDA to create regulations that “establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables…for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.” ⁸ These regulations needed to address multiple topics, including worker training and health and hygiene, agricultural water, biological soil amendments, domesticated and wild animals, and equipment, tools, and buildings. ⁶

In 2013, the FDA issued more than 140 pages of proposed produce safety rules for public review. ⁹ In response, the FDA received more than 36 000 public comments that addressed an array of serious public health, economic, and social justice concerns. ¹⁰ This public input also played a key role in the evolution of the produce safety rules. In this commentary, we focus on 3 concerns that symbolize the FDA’s dialogue with the public and the collaboration that led to the final standards: agricultural water, biological soil amendments, and Native American variance requests.

Agricultural Water

Agricultural water regulations were proposed to ensure that all water that is intended to (or likely to) come into contact with harvestable portions of produce or food-contact surfaces is safe and of adequate sanitary quality. These safety measures generated public concerns about their scientific basis and their economic impact on farms. The FDA proposed the adoption of the Environmental Protection Agency’s (EPA’s) recreational water quality standard for agricultural water—the same standard used for swimming areas. ¹⁰ The Washington State Department of Agriculture and the Pacific Northwest Vegetable Association challenged the soundness of the standard by comparing it with the irrigation water standards recommended by the World Health Organization for crops that are likely to be eaten raw. ^11,12 The original proposed standard for growing activities set a stricter limit for Escherichia coli, at 235 colony-forming units (CFUs) per 100 mL, ⁹ than the World Health Organization’s standard of 1000 CFU per 100 mL. ¹³ By setting such a restrictive standard, commenters were concerned that the regulations were creating an obstacle that did not correlate with additional food safety. The general cost of compliance was another concern. The proposed water standards not only contained a strict quality standard but also imposed a vigorous testing schedule. ¹⁰ Some farms would be required to test their water more than 52 times per year. In response to the proposed water standards, the National Water Resource Association argued that “the consequent monetary impacts upon farm units, dislocation of producers, their families, employees, suppliers, and related businesses will substantially damage the economies of the western states and, consequently, the US as a whole.” ¹⁴ In response, the FDA reduced the required frequency of water testing in the final regulations, with the frequency determined by the water source and past test results. The FDA kept the EPA recreational water quality standard as its benchmark but adopted the EPA’s revised recreational standard, which had been updated in 2012. This standard has an E coli limit of 410 CFU per 100 mL. ¹⁰

The evolution of the agricultural water standard reveals that a mandate for science-based standards does not always lead to one clear answer. The development of the water standard reflects the balancing of factors, food safety, and economic impacts on farmers. It also demonstrates the public’s important role in helping an agency see a broader range of regulatory options and implications.

Biological Soil Amendments

The proposed requirements for biological soil amendments of animal origin, such as manure, were also challenged. ¹⁰ In particular, an application interval was questioned (ie, the time between the use of a soil amendment and the harvest of the produce). Originally, the FDA proposed an application interval of 9 months for untreated biological soil amendments of animal origin. ¹⁰ This standard created 2 serious concerns. First, the proposed standard conflicted with the application interval established by US Department of Agriculture’s organic standards. ¹⁰ Second, the standard was not feasible in areas with shorter growing seasons (eg, the northeastern United States). ¹⁵ In response to this feedback, the final rule removed this application interval, and the agency deferred its decision on the appropriate interval. ¹⁰ Again, the public played an important role in shaping the produce safety rules by providing the FDA with reasoned feedback.

Native American Variance Requests

The FSMA required the FDA to create a variance request process for states and foreign countries when local growing conditions prevented compliance with the produce safety regulations. ¹⁰ Native American tribal governments were not listed in the statute, nor were they included in the proposed variance regulations. This controversial omission was seen as a slight to tribal sovereignty and detrimental to tribal agricultural interests because Native American tribal governments could not request accommodations for the unique growing conditions on their land. The ire generated by this omission was clear when one commenter stated, “The implicit or explicit exclusion of tribes from one of the most important provisions in the proposed produce rules is the most telling glimpse into FDA’s relationship with tribes in the implementation of these rules. Tribes have just been flatly excluded.” ¹⁶ In response to these concerns, the FDA indicated that it had always considered the variance available to tribal governments and set the issue to rest by explicitly including federally recognized tribes in the final rule. ¹⁰

Final Regulations

On November 27, 2015, almost 3 years after the proposed regulations were issued, the FDA finalized the produce safety rules. The 216 pages of final produce standards strive to “minimize the risk of serious illness or death from consumption of contaminated produce.” Importantly, the rule implements previously absent science-based measures to prevent adulterated food from entering the food supply, including standards for growing, harvesting, packing, and holding produce. In addition to relying on the FDA’s expertise, the final rules draw heavily on public comments, FDA-conducted meetings and listening sessions, and hundreds of FDA visits to farms. ¹⁰ If fully implemented, these regulations are expected to prevent more than 330 000 cases of food-borne illness annually, which would save the United States $925 million each year. ¹⁷

Implementation Challenges and Conclusion

Food safety advocates, organic food growers, and food distributors applaud the new rules. ¹⁸ However, additional challenges lie ahead for the produce safety system. For example, education and outreach will be critical in the process, given the complexity of the testing and importance of understanding the rules. Another key issue is funding. The US Congressional Budget Office noted “a gap between the FDA’s current food safety resources and the level of funding that will be needed to implement FSMA.” ¹⁹ In fiscal year 2016, the FDA requested and received $104.5 million in new budget authority in anticipation of implementing the final rules. However, the remaining FSMA funding gap is about $172 million. A further increase is essential in fiscal year 2017, primarily in the key areas of state funding for produce safety and ensuring the safety of imported food, to fully realize the public health and public confidence benefits promised by the FSMA. In his fiscal year 2017 budget request, President Obama proposed additional resources that include an increase of $25.3 million of new budget authority to implement the FSMA. ²⁰

As it stands, the new produce safety rules could make great strides in food safety. As the FDA’s deputy commissioner noted, however, “the ultimate success of FSMA depends on full funding.…This will help us train FDA and state food safety staff [members] on the new system, fund our state partners,…provide technical assistance to small farms and food businesses, and successfully implement the new import system that US consumers deserve and Congress envisioned.” ²¹ After approximately 5 years of development, it seems unreasonable and irresponsible to stifle our new produce safety system by failing to fund it adequately.