Policy options taken and ignored
U.S. and German risk managers were confronted with similar risks during the 2006 and 2011 outbreaks, yet they pursued different policy responses: industry-led agricultural controls in the U.S. and modest state reforms in Germany. The benefit of hindsight often makes historical events seem inevitable, but the outcomes of the 2006 and 2011 outbreaks were not guaranteed. Below I review five alternative outcomes (summarized in Table 1), some of which might have offered equal or superior improvements to public health but were never considered seriously by stakeholders. My goal is not to criticize risk managers in either nation but rather to provide readers with a broader context of available options that can clarify the social dynamics that elevated certain options over the alternatives.
Table 1 Five alternative policy options One potential response would be to consolidate government authority over food safety. Both the U.S. and German governments have faced decades of criticism for their fragmented authority over food safety, which is divided horizontally across agricultural and health agencies and vertically across federal, state, and local agencies (U.S. Government Accountability Office 1970, 1999; von Wedel 2001). Many interviewees agreed that government fragmentation is a major impediment to their work, yet stakeholders in neither nation attempted to consolidate food safety authority after the outbreaks. Interviewees were universally pessimistic about the possibility of restructuring regulatory authority, given that federalism is enshrined in both nations’ constitutions and that disruptions to the current regime would be contentious, costly, and time-consuming. In Germany, for example, interviewees described federalism as a “sacred cow”; in the U.S., a federal official told me that the public health system is so fragmented, “it is amazing that it works at all.” Nevertheless, interviewees felt like they had to make the best of a flawed system.
A second potential response would involve reexamining the food products associated with the outbreak, in this case bagged leafy greens (U.S.) and sprouts (Germany). Bagged greens are a recent invention, becoming a household staple only after technological advancements in the 1990s made it possible to produce them at scale (Stuart 2011). Although consumers love the convenience of bagged greens, these products carry a greater risk of contamination than whole or bunched greens due to differences in harvesting, centralized processing, and the sealed bags that create a hospitable environment for bacterial growth whenever the “cold chain” is broken. Despite these risks, no one seriously considered abandoning the bagged salad in the aftermath of the outbreak. One interviewee complained, “It’s not a safe product for so many reasons, but people want convenience. What’s unfortunate is that they don’t understand that that convenience comes with more risk.” Consumer fondness for bagged greens can be inferred from consumption trends during and after the outbreak: sales of bagged spinach dropped precipitously, but overall sales of bagged greens declined only slightly and then rebounded as consumers substituted other greens for spinach (Arnade et al. 2009).
Raw sprouts are even riskier than bagged greens, yet the idea of giving them up was similarly ignored in Germany. The warm, humid conditions required for sprouting are ideal for rapid bacterial growth, such that sprouting can amplify even small levels of pathogens. Many interviewees admitted privately that they avoid eating sprouts because of their heightened risk of contamination; “I love sprouts, but I won’t eat them,” said one respondent. However, sprouts consumption continued post-outbreak, and government officials, who reported in interviews that they feared getting sued for “communicating too much” about the risks of consuming sprouts, issued only a mild warning that people with “weak immune systems” might avoid eating sprouts (BfR 2011). One scientist said, “I don’t think anything has changed. Sprouts are still served. They are still perceived as a healthy food.”
A third potential response would be to reexamine the production practices that make bagged leafy greens and sprouts so risky. For example, hand-harvesting leafy greens allows for easier visual identification of contamination relative to mechanical harvesters, and processing greens in smaller batches reduces the spread of contaminants. Although U.S. manufacturers have implemented numerous technical strategies to manage pathogenic risks, there has been no serious consideration of adjustments that might challenge the current scale or pace of production (Stuart 2011; Stuart and Worosz 2012). With sprouts, research suggests that several practices may kill or slow the growth of pathogenic bacteria, including chlorine washes and lower sprouting temperatures (Fu et al. 2008; U.S. FDA 1999). However, European producers and consumers have actively resisted the use of chlorine on food (in contrast to the U.S.), and lower sprouting temperatures threaten profitability by lengthening production times and requiring more water and energy. The EU regulations developed after the 2011 outbreak do not contain requirements, or even suggestions, for specific preventative controls. They merely require member states to verify that sprout operators maintain clean facilities, use clean water, and regularly test sprouts and water for microbial contaminants. Several interviewees recognized the lack of policy specificity as a missed opportunity; for example, one interviewee said, “I think the learnings taken out of that outbreak are much poorer than they should have been.”
A fourth policy alternative would be to regulate cattle, the primary animal reservoir of pathogenic E. coli. Pathogenic E. coli pass from cattle to humans via the “fecal–oral” route, when humans consume food or water contaminated with cattle feces. Cattle feedlots can produce millions of tons of untreated manure each year, making them a major vector for E. coli transmission via manure runoff that contaminates soil, air, and waterways, or is tracked through nearby fields by wildlife (Ali 2004). Although U.S. investigators traced the 2006 outbreak strain to a nearby cattle feedlot, there was little discussion about regulating feedlots after the outbreak. Stakeholders could have mandated treatment of cattle manure, established minimum distances between feedlots and agricultural fields, implemented stricter controls on manure runoff, or incentivized culling of infected cattle (given research suggesting that a small percent of cattle, as little as 2%, are E. coli “super-shedders”) (Arthur et al. 2013; Matthews et al. 2006). However, none of these options were seriously considered, much to the irritation of produce growers who felt unfairly burdened with another industry’s problem. As one grower said, “The evidence is pretty clear that animal confinement operations are a big source of these pathogens, but no one is pointing a finger in that direction. It’s really frustrating.” German and European stakeholders similarly avoided regulating cattle in the aftermath of the 2011 outbreak, though the link to cattle was less clear in this case. As in the U.S., ruminants are the primary reservoir for E. coli infections in Europe, but evidence suggests that the rare strain implicated in the 2011 outbreak might have a human, not ruminant, reservoir (Beutin and Martin 2012; Karch et al. 2012). The origins and transmission pathway of the 2011 outbreak strain raise important questions for public health, underscoring the lesson that infectious diseases are constantly evolving and that mitigation efforts must be correspondingly adaptive.
A final option would be to do nothing. This might seem like an implausible response to a major public health crisis, but it is worth noting that the U.S. leafy greens industry had already pursued this strategy during the dozens of outbreaks prior to the 2006 outbreak (Powell and Chapman 2018; Turner et al. 2019). This strategy proved untenable during the 2006 outbreak because the U.S. spinach market evaporated after the FDA’s consumer advisory, forcing industry players into a collective financial crisis. With no market for fresh spinach and increasing safety demands from buyers, “the industry pretty quickly got it through their heads that they had to do something significant,” as one grower explained. In Germany, critics sometimes argue that “doing nothing” is precisely the strategy taken after the 2011 outbreak, but this is not quite accurate: federal agencies implemented some minor improvements to organizational procedures following the outbreak, and the EU established new standards for sprouts producers. However, it is important to note that in contrast to the U.S. response, the German response was oriented more toward improving responses to future outbreaks rather than preventing them. One interviewee noted that although previous crises like the BSE crisis “showed very severe problems with state audits of food and nutrition and problems with federalism, that was not the issue with EHEC. The problem with this scandal was that it took so long to identify the source.”
By reviewing several plausible alternative responses to the outbreaks in question, we can appreciate that the outcomes were neither inevitable nor necessarily superior to the alternatives. Indeed, some of these alternatives would have addressed systematic vulnerabilities in the food system that were largely ignored by U.S. and German risk managers, which raises the question of how stakeholders came to pursue the observed responses. Below I present two themes that emerged in the analysis that help explain the policy responses: social constructions of the outbreaks and organizational dynamics among state, industry, and public actors.
Social constructions of the outbreaks
In interviews, regulators and industry representatives in both nations reported that the 2006 and 2011 outbreaks were the events that “woke them up” to the risks of fresh produce. Nevertheless, these events came to be understood in qualitatively different terms: U.S. stakeholders understood the outbreak primarily as a problem with the way fresh produce is produced, whereas German stakeholders understood the outbreak as a problem with outbreak response. Food safety spans the professional domains of agricultural and health experts, and both fields are necessarily engaged in food safety governance in both nations; even so, greater emphasis can be placed on one or the other domain in policy discourses. In the 2006 and 2011 outbreaks, this difference in framing helped shape policy responses: U.S. stakeholders created an industry-led program for farm-level food safety management, whereas German stakeholders sought to improve inter-organizational coordination during outbreak investigations.
Another key dimension of the social construction of these outbreaks is related to whether they were understood to involve internal versus external threats. The U.S. outbreak was quickly traced to California-grown spinach, and the fresh-cut spinach market collapsed soon after the FDA warned consumers to avoid eating fresh spinach in mid-September 2006. These events forced spinach producers to recognize the outbreak as an internal threat to their financial viability and spurred them to collective action. One grower explained that at the time, he and others were “desperately trying to figure out a way to at least impress upon the regulators that we can restart this industry safely.” It is important to note that although industry groups were motivated to address the financial threat of contaminated spinach, they did not necessarily acknowledge personal responsibility; as previously noted, regulatory proposals focused on farm-level controls despite evidence of failures at the processing facility, and blaming “nature” enabled stakeholders to pursue targeted technical fixes rather than structural reforms (Olimpi et al. 2019; Stuart 2011).
In contrast, German officials blamed the 2011 outbreak on actors external to the EU, in Egypt, which reduced political pressures for reform (BfR 2012). Although the implicated seeds were imported from Egypt, doubts remain about where the seeds were contaminated (Beutin and Martin 2012; Knödler et al. 2016), and sprouting facilities represent an important intervention opportunity regardless of whether the contamination occurred outside Europe. The official conclusion blaming Egypt for the contaminated seeds meant that decision-makers could halt Egyptian imports and claim that the threat had been neutralized. One microbiologist said, “Politically, it was great. You had somebody outside the European Union responsible for it.” Others criticized the response, including a consumer advocate who said, “I always think this government lost the opportunity to really do better in the future, because they had that solution of Egypt, which is cheaper than saying, ‘look, we have to reset the system.’” Social construction of the crises as involving internal or external threats shaped the subsequent response; internal threats require greater internal evaluation, a more disruptive process than blaming an outsider who can simply be expelled from the market.
Social constructions of the problem as primarily agricultural or health-related, and stemming from either an internal or external threat, therefore oriented stakeholders toward a preventative policy response in the U.S. and a reactive response in Germany. German interviewees viewed the 2011 outbreak as an unfortunate crisis that demanded a quick public health response but failed to reveal systemic vulnerabilities in food supply chains. Microbial contamination was viewed as an unfortunate inevitability: as more than one interviewee remarked, “these things happen.” Interviewees focused on the public health response and largely agreed that aside from a few minor mistakes (most notably the Spanish cucumber announcement), the organizational response was appropriate. For example, a Hamburg official said, “If this EHEC outbreak was a catastrophe for everyone, maybe we would have had to change the [regulatory] structure. Maybe.” A federal epidemiologist expressed a similar sentiment, saying, “If this had been a disaster—it was a disaster for all the people affected—but the way it was managed, I think, wasn’t a disaster.” Conversely, U.S. stakeholders did not accept microbial contamination as a sad inevitability but rather viewed it as a problem ripe for intervention. Industry representatives expressed confidence in their ability to identify technical solutions to pathogenic contamination on produce, and industry players banded together to fund basic research on food safety through the newly established Center for Produce Safety at the University of California, Davis. As one grower explained, “It was a defining moment for the industry, no doubt about it. And for a good reason. This is the same food that I take home and put on the table for my family and it’s the same food our employees take home, so it’s got to be safe.” No one I interviewed believed that it will ever be possible to eliminate foodborne risks, but U.S. stakeholders expressed greater resolve than their German counterparts to achieve significant risk reductions.
Divergent national food risk regimes
The institutionalized relations among key stakeholder groups—including government regulators, the food industry, and public organizations—emerged as a key theme in interviews, with respondents frequently pointing to longstanding organizational dynamics to explain policy outcomes. I use the concept of national food risk regimes to describe the networks of public and private actors that govern food safety in different national contexts, encapsulating the balance of power across these actors, institutionalized relations among them, and collective values that shape their activities (Hood et al. 2001). Food risk regimes emerge from ongoing negotiations among state, industry, and third-party organizations, and they fluctuate over time in response to food-related crises. Nevertheless, certain dimensions of U.S. and German food risk regimes achieved relative stability by the end of the twentieth century and laid the groundwork for the responses to the 2006 and 2011 outbreaks.
The paragraphs below illustrate how the organizational dynamics of national food risk regimes interacted with social constructions of the outbreaks to produce policy outcomes. Table 2 summarizes key dimensions of each food risk regime that emerged inductively from the data, organized by Hood et al. (2001) framework for regulatory regime content (size, structure, and style) and context (risk type, public attitudes, and organized interests). The analysis begins with the state agencies tasked with governing food safety (regime content), then assesses their relations with industry actors and the public (regime context). Critically, many of these dynamics remain important components of U.S. and German food risk regimes, the implications of which are discussed in the final section.
Table 2 Food risk regimes in the United States and Germany (with differences in italics) Government structures and relations in the U.S. and Germany
Both the U.S. and Germany have federalist political systems, meaning that a central (federal) government shares authority with regional (state) governments. Agriculture and public health are jointly regulated by federal and state governments in both nations; legislation is generally passed at the federal level and implemented by states. States assume responsibility for food safety inspections, infectious disease surveillance, and outbreak investigations (unless state officials formally invite federal authorities to participate). U.S. and German food risk regimes therefore share important similarities, but significant differences remain in their structure and activities.
Horizontal and vertical divisions of power are similar across both nation’s public health agencies, but the organization of national agricultural agencies differs. In the U.S., federal agricultural authority is divided across different types of foods: meat and dairy are regulated by the US Department of Agriculture (USDA), and all other foods are regulated by the FDA. Risk assessment and management are handled internally by both agencies. In contrast, German agencies are divided by function rather than product: German agencies were reorganized after the BSE crisis to impose strict divisions between the authorities responsible for risk assessment (Federal Institute for Risk Assessment, or BfR) and risk management (Federal Office of Consumer Protection and Food Safety, or BVL, and Federal Ministry for Food, Agriculture, and Consumer Protection, or BMELV). Both of these fragmented systems create regulatory challenges, but only the weaknesses of Germany’s system became salient during the outbreaks under study. The U.S. system poses challenges especially for outbreaks involving multi-ingredient products and for regulatory parity across different types of products.Footnote 3 However, the 2006 U.S. outbreak was quickly traced to a single commodity, so the FDA’s authority over the investigation was never in dispute. In Germany, the division between risk assessment and risk management contributed to organizational frictions during the outbreak investigation; stakeholders on either side of the divide knew less about each other’s work than would have been ideal for a swift and coordinated response, contributing to confusion about which food products were implicated in the outbreak. As one federal epidemiologist explained:
The difficult point is the separation between the human disease side and the food safety side. You have those two sides and then somewhat of a barrier between them, but then you have that times 16, basically. And actually, in a way, you have it times 400 because every health department that you work with is a bit different. That makes it so cumbersome, and I can never get over that it’s so ineffective.
The issue of multilevel governance also drives important differences in food risk regimes. Germany is a federalist nation embedded in another quasi-federalist political system: the European Union. Multilevel governance can weaken risk management when authority is divided in such a way that no officials or agencies can be held individually responsible for disasters, a phenomenon that Beck (1998, p. 18) calls “organized irresponsibility.” National crises are often expected to yield national policy responses, yet the German federal government was in some ways the worst-positioned to make substantive reforms after the 2011 outbreak. Food safety regulations are established one level above (i.e., the EU) and implemented one level below (i.e., the Länder, or federal states). The federal level plays a coordinating role in the domain of food safety and has limited powers to impose new programs on federal states and municipalities. Given that the outbreak was widely framed not as a European problem but as a German problem, EU authorities felt no great pressure to pursue strong preventative measures, and German agencies lacked the authority to do so themselves. The net result was a system in which no level of governance contained officials who felt responsible for preventing the next outbreak. The muted policy response to the 2011 outbreak was therefore at least partially a result of “organized irresponsibility” among government agencies.
Beyond the formal structures of governance, the relations between agencies also play a significant role in shaping outbreak responses. U.S. food safety officials operate within a fragmented policy arena but have pursued programs and processes that foster regular inter-agency collaboration. Federal agencies often contract with state authorities to fulfill their regulatory responsibilities, and federal agencies also foster horizontal collaboration by placing representatives in each other’s offices and convening regular meetings. Additionally, the sophisticated national disease surveillance network ensures that state and federal agents regularly communicate about emerging health threats. Although the process of reporting infectious diseases proceeds similarly in both nations, the U.S. system contains a stronger bureaucratic mandate to identify pathogen strains via molecular subtyping (or, increasingly, whole genome sequencing). The pathogen strain has no clinical significance, but it is critical for national disease surveillance. Molecular subtyping and whole genome sequencing allow U.S. authorities to identify outbreaks with greater precision and detect smaller and more geographically diffuse outbreaks. Moreover, because the U.S. surveillance system identifies emerging outbreaks with greater frequency, U.S. agencies collaborate more often on outbreak investigations.Footnote 4 The result is a system in which officials have good working knowledge of the people and processes in other agencies and can draw on these relationships during crises. I do not mean to romanticize the social relations among U.S. risk managers; interviewees also described the types of turf battles and personality clashes present in most human organizations. However, compared to the strictly siloed German system, U.S. authorities demonstrated stronger commitments to inter-agency cooperation, and they cited these ties during interviews as being important for successful outbreak investigations. As one federal official said:
The system we have is not a system that anybody would ever design to do an outbreak investigation, but what we’ve been able to do is despite the organizational challenges, we’ve figured out a system so that we can work collaboratively together to solve outbreaks and do it relatively expeditiously. Part of it is setting up good laboratory-based systems, having good epidemiological approaches, and having good regulatory environmental health assessment, those three big pieces all happening at the same time and having dedicated partners and resources who can make the individual pieces happen and have them all put together.
In Germany, stricter divisions between the agencies involved in risk assessment and risk management, federal and state agencies, and public health and agricultural agencies have created a system in which officials largely pursue their own work without regular inter-agency collaboration. Korinek and Strassheim (2013) describe the German food safety governance regime as lacking “conceptual slack,” since organizational boundaries prevent experts from different backgrounds from sharing their experiences and expertise. During the 2011 outbreak, German authorities failed to formally coordinate their activities until several weeks into the investigation, after officials in Hamburg mistakenly announced that Spanish cucumbers were the source of the contamination. Instead, state agencies conducted parallel, independent investigations, and some were reluctant to share their data with other state and federal authorities. This created delays and mistakes during the investigation that might have been avoided. Moreover, these failures likely reinforced the general impression that the “problem” represented by the outbreak was in the public health response, not in agriculture. German officials universally praised the EHEC Task Force they formed during the investigation; for example, one official said “it was one of the most important lessons we learned, that you have to bring these three levels [federal, state, and local] on a daily basis together.” However, the culture of government silos was so strong that the task force was disbanded after 1 month, and no serious attempt was made to continue regular collaboration. Officials established a process for re-establishing the task force during national crises, but it has re-formed only once since then (during a 2012 norovirus outbreak). The interpersonal learning that occurred during the 2011 outbreak therefore failed to disrupt inter-agency dynamics. Given staff turnover in the years since the task force last met, it is likely that organizational lessons learned during previous crises will need to be relearned during the next crisis.
Food industry actors in the U.S. and Germany
The balance of power between state and industry actors varies cross-nationally and has also fluctuated over time. In the U.S., industry actors have exerted substantial power in the food policy arena over the previous half-century and have frequently succeeded in resisting the expansion of federal oversight (Thomas 2014). The “revolving door,” whereby industry actors transition in and out of public office, also ensures that industry perspectives are well-represented in policymaking and enforcement. The outsized influence of the food industry in U.S. food safety governance helps explain why leafy greens growers were granted such latitude in determining the policy response to the 2006 E. coli outbreak. California regulators considered imposing mandatory regulations after the outbreak, but industry organizations convinced them to abandon their plans and allow industry leaders to pursue their own policy solution instead (Schmit 2007). In Germany, in contrast, the food industry’s influence in policymaking has declined over the last half-century, especially after the BSE crisis prompted federal reorganization in the early 2000s. This helps explain why industry representatives were relatively absent from policy debates following the 2011 outbreak. EU regulators consulted members of industry during the development of the 2013 sprouts regulations, but it was never suggested that industry organizations could lead the reform efforts. Industry-state relations therefore constrained which responses to the outbreaks were considered legitimate.
It is also important to assess structural features of the implicated food industries to understand the direction of the policy responses. Although the 2006 U.S. and 2011 German outbreaks were traced to similar food products (i.e., fresh salad ingredients), these products came from vastly different industries. The U.S. leafy greens industry is a multi-billion dollar industry, with 83% of U.S. households consuming bagged leafy greens (Cook 2015). The industry is also highly concentrated, with four firms controlling almost 90% of the fresh-cut salad market in 2006 (Cohen 2008). In contrast, the European sprouts industry is small and decentralized, and it produces a product that many enjoy as a garnish but few would consider a staple.Footnote 5 In 2011, the sprouts industry consisted of around 100 businesses scattered throughout the EU. European sprouts production was a EUR 200 million industry, with EUR 30 million (15%) being produced in Germany (EFSA 2011).
Differences in the size and concentration of the implicated industries played a role in shaping policy responses to the two outbreaks. In the U.S., the leafy greens industry could mobilize relatively quickly by virtue of their vast resources, in-house expertise, and market concentration; with few players controlling most of the fresh-cut market, only a handful of firms had to endorse the Leafy Greens Marketing Agreement for it to ensure virtually industry-wide compliance. Moreover, several firms already had food safety specialists on staff (and others would follow suit), enabling industry actors to leverage their own scientific expertise in the bid to develop a legitimate policy response. In contrast, it is unlikely that the small, decentralized sprouts industry in Europe could have achieved a similar effort even if sprouts operators had been more coordinated. Few, if any, had the resources to hire scientists to develop and oversee internal food safety programs, let alone create an industry-wide program.Footnote 6 Thus, the U.S. industry-led policy response required an implicated industry that was powerful and concentrated enough to manage the coordination costs of the LGMA. The German outbreak similarly involved massive economic losses for sprouts producers, but they lacked the power and coordination to launch a similar response.
The absent public
Public mobilization and accountability often shape institutional responses in other policy domains, yet microbial food safety garners little public engagement in either nation.Footnote 7 This contrasts with spirited public responses to other food-related concerns, such as genetically modified foods, pesticides, and antibiotics. Few consumer organizations focus specifically on the issue of microbial food safety, and those that do often focus more on consumer education and advocacy than on organizing grassroots campaigns.Footnote 8 Risk managers also rarely engage in public outreach on food safety-related policymaking. In interviews, risk managers claimed to consider public expectations in selecting among policy options, but these comments usually reflected shared assumptions about public opinion rather than insights gleaned from direct engagement.
This commonality between U.S. and German food risk regimes cannot explain the observed policy divergence, but it does help explain why both national responses largely reinforced the institutional status quo. Food safety is a “policy without a public” in both nations (May 1991): an issue which fails to sustain much public conflict and for which relevant policy discussions tend to be dominated by technical experts outside of the public sphere. Risk managers in this domain are subject to less public accountability than risk managers in other policy domains, so they face reduced pressure to demonstrate broadscale reforms after crises (unless the crises involve obvious malfeasance). Greater public engagement after the 2006 and 2011 outbreaks might have strengthened food safety governance in both nations if regulators had felt pressure to pursue larger or more holistic reforms, including the solutions discussed above in “Policy options taken and ignored” section.