At the federal level, the US Food and Drug Administration establishes rules and sets general regulations that apply to all producers in all US states. In California, the California Department of Public Health and California Department of Food and Agriculture undertake guidance, inspection and enforcement of these federal rules at the state and local level. The US regulatory framework for food safety in fresh produce begins with the 1938 Federal Food Drug and Cosmetics Act , which established the United States Food and Drug Administration as the controller of food and drug safety at the federal level. The FD&C Act and its amendments prohibit “the introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded” , in which adulteration may include the presence in food of “any poisonous or deleterious substance which may render it injurious to health” . In 2011, a significant change to the FD&C Act came in the form of the Food Safety Modernization Act, Pub. L. 111-353 . FSMA amended the FD&C Act to expand the power of FDA to regulate how foods including fresh produce are grown, harvested and processed. FSMA’s Section 105: Standards for Produce Safety called for the creation of a rule providing sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities” . In 2015, pursuant to the Food Safety Modernization Act of 2011 , FDA released the final version of its Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption . The rule represented the first time that federal regulations had included a field-level safety standard for fresh produce, vertical farming systems marking an extremely hands-on and top-down form way of controlling how food is grown.
In response to FDA analysis of CDC data indicating that many food safety problems enter the supply chain during primary production and early handling and storage of fresh produce items the Produce Rule was designed by FDA to refocus food safety mitigation efforts on prevention rather than reaction, through the establishment of science-based minimum standards for produce safety. Key practices required by the Produce Rule include testing requirements for irrigation water, record keeping requirements, standards for the timing of compost application, worker health and hygiene requirements, equipment and facilities requirements, and specific limits for E.coli levels in irrigation water with zero detectable E.coli in water that washes or contacts edible portions of crops . At the state level, CDFA has released guidance documents and electronic resources which interpret relevant FSMA subsections, providing guidance through a range of public-facing programs which aim to “educate then regulate” toward full compliance with the law. Structurally, these two approaches to regulating food safety through state regulation are broadly similar. Both UK law and US law include regulatory goals at multiple levels, with the highest level setting out general objectives and definitions in the pursuit of safe food, and lower levels providing specifics and interpretation of statutes for on-the-ground implementation and enforcement. Both approaches also contain similar language setting out the targets of food safety regulation in absolute terms such as “safe food,” which explicitly seek to avoid threats, rather than reducing them to an acceptable level. However, the UK’s legal framework under EU law 5 contains an explicit focus on use of the precautionary principle in regulation, and specific requirements relating to traceability, both of which are not emphasized to any comparable degree by US laws. Differences also exist in overall style of the regulations. The EU level contributes a strong emphasis on cooperative process and stakeholder education, and stresses the importance of food businesses as the actor group closest to the problem of food safety and therefore best situated to solve it.
The regulatory model evidenced by the UK’s due diligence framework acts to protect food businesses from threats beyond the realm of reasonable caution. In this sense, the UK is relying on a liability framework for risk management in fresh food products, something that sets UK food safety management apart from US food safety management through direct regulatory standards. FSA operates through an arm’s length relationship with food businesses, in which it is tasked with regulating their actions through audits and inspections but does not have the power to directly enforce or prosecute. Rather, FSA oversees the activity of local city and district governments who act as food safety enforcement bodies. These Local Authorities employ auditors and inspectors who visit food producers to ensure that production standards are being met and hygiene requirements are being followed by food businesses. The central FSA as a result tends to communicate in the form of guidance, with control of deployment devolved entirely to the local level. This arm’s length arrangement can make it challenging for FSA to direct activities at local level, but it also allows for general principles to be more effectively tailored to local or regional concerns. In comparison, the US model contains similar efforts toward cooperative education-based regulation, but at a lower level. Collaborative efforts to educate at the state level are still back grounded by the context of inspection and punitive sanctions from federal level.From my research, The UK “due diligence” defense framework embedded in the UK’s 1990 Food Law appears to structure responses to food safety concerns differently than the US focus on regulatory mechanisms for holding producers accountable. Based on my data, the effect of this provision has been to motivate a deep and broad care for food safety risks, first at the level of the largest retail corporations, and then downward along the supply chain. It is deep because suppliers and retailers know that they are legally responsible for being circumspect in their attention to risks, and broad because attention is focused on a broad suite of potential sources of risk, rather than zeroing in on only one source .
This breadth was evident in my interviews when suppliers and retailers spoke of risks from pesticides in the same breath as they mentioned risks coming from pathogenic agents in food. Food safety risk in the UK is thought of as coming from a wide variety of sources. In addition, many UK interviewees at both policy and industry level commented to me that food safety and environmental health are seen as linked concepts, in that a healthy environment is perceived as generating safer food.The kind of public criminal codes and legal mechanisms underpinning the due diligence approach do exist in US law, and they may be experiencing a resurgence in active enforcement which is beginning to shift thinking among industry leaders. However, due to differences in legal structures, cannabis grow room criminal justice systems, and underlying societal attitudes, the nascent criminal liability approach may be taking a much more punitive form in the US than it currently takes in the UK. In 2015 five employees from the Peanut Corporation of America were sentenced to federal prison terms for their roles in distributing salmonella-contaminated peanut butter products to institutional buyers across the United States in 2008-2009, causing nine deaths and 714 illnesses across 46 US States. This case is an example of a recent application in US law of the Park Doctrine in US law, whereby an individual in a position of responsibility within a corporate entity can be held personally criminally liable for harms caused by that corporation’s activities, even if it cannot be proven that the individual in question acted personally or knowingly as part of the wrongdoing. Although the executives sentenced in the case of the Peanut Corporation of America had knowingly sold contaminated products, the statute invoked in their trial could equally be used to convict an executive who should have known, but did not. This difference in the protections afforded to food producers signals a harsher and punitive framework, with fewer protections in place to allow retailers any measure of security should food safety violations happen despite rigorous controls.My research revealed structural differences between the two industries that create stark contrasts in how food safety risk is handled. Contrary to US farmers who most commonly sell to packer/shippers, UK producers most commonly sell directly to a grocery retailer . My farmer surveys illustrate this trend: None of the UK producers interviewed during my research reported selling their leafy greens to a packer/shipper. Instead, the majority sold directly to a grocery retailer, accomplishing many of the intermediate steps such as trimming and bagging while still in the field . California leafy greens farmers, by contrast, are typically 6 growers and harvesters only. They sell their products to intermediaries such as processors, pack houses, packer-shippers, and wholesalers, with products changing hands multiple times between initial harvest and final sale to the consumer.
Farmers in both geographic regions complain that there are too many standards they must follow simultaneously, and a challenging lack of harmonization between different sets of requirements. My research reveals that in both locations, farmers feel negatively about the overlap and proliferation of private standards, but in CA, the structure of the leafy greens industry creates more opportunities for overlapping standards to disagree. In the UK, the larger number of private standards still creates this possibility, but the structure of the industry eliminates the potential for industry buyers to impose different requirements than the prevailing private standards. In CA, the Leafy Greens Marketing Agreement produce standard functions as its own private entity, not owned by government, by retailers, or by farmers. As a marketing agreement under US law, it invokes the inspection powers of the California Department of Food and Agriculture and the USDA to back its standard but sets and promulgates its own rules . Because the standard is not operated by the downstream buyers and retailers in the supply chain, there is sometimes conflict between the requirements that buyers impose, and the requirements of the LGMA certification standards. Research indicates that CA farmers feel their buyers often impose requirements on them that are not part of private standards like the LGMA, let alone the background regulatory process . For example, some buyers in California went beyond the LGMA requirements, adding their own seemingly arbitrary requirements for leafy greens growers around allowed soil amendments and appropriate time intervals to be followed when harvesting land that had been exposed to floodwater during weather events . In the UK system, the setters of private standards and the downstream buyers are the same entity; grocery retailers are by far the biggest buyers, and many have their own standards which suppliers must follow in addition to public regulatory rules. But because the retailers own and operate the standards, there is no time when the retailer as downstream buyer will specify different measures from what the relevant produce safety standard—in this case also created by the retailer—commands.Echoing results at policy level, the subset of standards that I examined indicated that food safety is managed in a more holistic way by private standards active in the UK than by those operating in CA. UK standards range more widely, often including additional values such as environmental health, social justice concerns, animal welfare, and chemical safety alongside food safety requirements. By contrast, US food safety controls follow a narrower focus on specific foodborne pathogens, and may contain few if any mentions of other concerns. This separated, piecemeal approach to ensuring diverse public goods encourages management of food safety goals in a vacuum, and my research supports the idea that this may pit different goals against one another rather than encouraging their mutual achievement. Each of the eleven standards for which an audit checklist could be obtained were evaluated and categorized clause-by-clause according to two parameters: Style and Focus. Style was measured by how many of the audit clauses in each standard were prescriptive in nature , vs. how many were process-oriented . Focus was measured by how many of the audit clauses in each standard were focused on achieving increased food safety, vs. how many were focused on achieving better environmental health.This section of my analysis also takes into account that many farmers carry multiple certifications at the same time, and aim to meet multiple overlapping sets of requirements and standards at once. For example, the BRC Global Food Safety Standard and the Red Tractor Assured Fresh Produce Standard are used as pre-regulatory risk assessments in the UK which prioritize state regulatory enforcement measures, meaning that all producers must go through these audit processes in order to be able to sell their products through grocery retailers.