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1. ARTICLE: A Systems Theory of Tort Law: Reevaluating the Case Against "Regulation by Litigation", 90 Mo. L.
Rev. 385
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ARTICLE: A Systems Theory of Tort Law: Reevaluating the Case Against "Regulation by Litigation"
ARTICLE: A Systems Theory of Tort Law: Reevaluating the Case Against "Regulation by Litigation"
Spring, 2025
Reporter 90 Mo. L. Rev. 385 *
Length: 14858 words
Author: Timothy D. Lytton*
Highlight
ABSTRACT
For decades, critics of tort law have argued that lawsuits are a poor substitute for government regulation. These detractors compare the institutional capacities of courts and agencies, and they conclude that litigation is ineffective, inefficient, and illegitimate as an alternative to notice-and-comment rulemaking. In response, this Article asserts that characterizing tort law and administrative regulation as alternatives obscures their interdependence. By using systems theory to model this interdependence, the Article argues that any fair-minded assessment of tort litigation's contribution to regulatory governance requires understanding it as part of a system. Ignoring the systemic impacts of tort litigation overlooks the subtle ways in which it enhances expertise, stakeholder participation, feedback, and learning in regulatory regimes.
To illustrate, the Article examines the most urgent food safety problem currently facing U.S. consumers: foodborne illness outbreaks caused by leafy greens contaminated with virulent microbial pathogens. Systems theory demonstrates how tort litigation has played a vital role in the development of government regulations and industry standards to reduce the risk of contamination. Through interactions with media coverage, consumer advocacy, and insurance underwriting, tort litigation has shaped and motivated the development of the food safety standards that govern leafy greens production. From a careful analysis of how lawsuits have advanced food safety policy, the Article derives a general theory of the interdependence of tort litigation and government regulation.
Text
[*387] I. INTRODUCTION
* Regents' Professor and Professor of Law, Georgia State University. I am grateful to Ken Abraham, Nora Freeman Engstrom, Andrew Morriss, Bob Rabin, and Peter Schuck for helpful feedback on an earlier draft.
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ARTICLE: A Systems Theory of Tort Law: Reevaluating the Case Against "Regulation by Litigation"
The use of tort law to pursue regulatory goals is controversial. Critics disparage lawsuits aimed at reducing smoking, gun violence, and opioid addiction as "regulation by litigation," and they argue that litigation is an ineffective, inefficient, and illegitimate substitute for legislation and notice-and-comment rulemaking.1 These critics do not deny that tort liability is sometimes a justifiable response to wrongdoing, may provide much-needed compensation to injury victims, and can advance general deterrence of unreasonable risk taking. Moreover, they admit that tort litigation does, in some instances, fill regulatory gaps and catalyze administrative regulation.2 What they object to is litigation that results in judicial remedies or negotiated settlements that "impose forward-looking regulatory constraints on an entire industry."3 According to these critics, litigants and courts are generally less equipped than legislatures and administrative agencies to evaluate technical information, establish sound priorities, implement regulations, monitor results, and make adjustments.4 Moreover, critics argue that policies resulting from litigation involve less public input and accountability compared to government regulation, serving the private or political interests of the litigants rather than the public interest.5 According to one leading study, "litigation is at best an imperfect substitute for a regulation imposed through rulemaking or negotiation."6
Defenders of using tort law to advance regulatory policy emphasize how litigation interacts with and complements legislative politics and [*388] agency rulemaking.7 They point out how lawsuits can frame issues in new ways, give them greater prominence on the agendas of legislatures and agencies, uncover policy-relevant information through civil discovery, and mobilize reform advocates.8 These alternative accounts suggest that evaluating litigation as a means of advancing regulatory policy depends not only on assessing it as an alternative to regulation by
1 E.g., ANDREW P. MORRISS ET AL., REGULATION BY LITIGATION 1-2, 49-54 (2009); W. Kip Viscusi, Overview, in REGULATION THROUGH LITIGATION 1-4 (W. Kip Viscusi ed., 2002); Daniel P. Kessler, Introduction, in REGULATION VERSUS LITIGATION 2-4 (Daniel P. Kessler ed., 2011).
2 E.g., Viscusi, supra note 1, at 3 (noting that asbestos lawsuits exemplify how "litigation can often help address gaps in the regulatory structure and stimulate regulatory activity"); MORRISS ET. AL., supra note 1, at 103 (detailing how silicosis litigation in the 1930s "spurred the political process to address the issue" by prompting an expansion of workers' compensation coverage).
3 MORRISS ET AL., supra note 1, at 2; see also Viscusi, supra note 1, at 1 (objecting to litigation that "results in negotiated regulatory policies to settle the suit or serves as a financial lever to promote support for governmental policies"); Kessler, supra note 1, at 3 (describing objections to "the use of litigation as a means to force companies to accept regulation outside of the normal political process").
4 Peter H. Schuck, Why Regulating Guns through Litigation Won't Work, in SUING THE GUN INDUSTRY: A BATTLE AT THE CROSSROADS OF GUN CONTROL AND MASS TORTS 234-35 (Timothy D. Lytton ed., 2005).
5 Viscusi, supra note 1, at 1; MORRISS ET AL., supra note 1, at 49, 54, 114-115.
6 MORRISS ET AL., supra note 1, at 51.
7 Douglas A. Kysar, The Public Life of Private Law: Tort Law as a Risk Regulation Mechanism, 9 EUR. J. RISK REGUL. 48, 63 (2018); Timothy D. Lytton, HOLDING BISHOPS ACCOUNTABLE: HOW LAWSUITS HELPED THE CATHOLIC CHURCH CONFRONT CLERGY SEXUAL ABUSE 190-91 (2008) [hereinafter LYTTON, BISHOPS]; see also Peter D. Jacobson & Kenneth E. Warner, Litigation and Public Health Policy Making: The Case of Tobacco Control, 24 J. HEALTH POL. POL'Y & L. 769, 786-91 (1999).
8 Nora Freeman Engstrom & Robert L. Rabin, Pursuing Public Health through Litigation: Lessons from Tobacco and Opioids, 73 STAN. L. REV. 285, 354 (2021); Douglas A. Kysar & Conor Dwyer Reynolds, Regulation through Recourse: Rediscovering Tort as Regulation (Feb. 1, 2024), https://dx.doi.org/10.2139/ssrn.3449770 [https://perma.cc/7GUX-7GLM]; CHARLES R. EPP, MAKING RIGHTS REAL: ACTIVISTS, BUREAUCRATS, AND THE CREATION OF THE LEGALISTIC STATE 22-23 (2010); Timothy D. Lytton, Using Tort Litigation to Enhance Regulatory Policy Making: Evaluating Climate-Change Litigation in Light of Lessons from Gun-Industry and Clergy-Sexual-Abuse Lawsuits, 86 TEX. L. REV. 1837, 1838 (2008) [hereinafter Lytton, Using Tort Litigation].
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ARTICLE: A Systems Theory of Tort Law: Reevaluating the Case Against "Regulation by Litigation"
legislatures and administrative agencies but also on appreciating its interactions with these and other institutions as part of a system.9
This Article develops a systems theory of tort law. In analyzing tort law's regulatory impact, systems theory supplements comparative institutional analysis which assesses the relative strengths and weaknesses of courts, legislatures, and administrative agencies viewed in isolation with an evaluation of how each of these institutions influences the performance of the others.10 Instead of analyzing litigation and government regulation as alternatives, systems theory emphasizes their interdependence. Moving beyond comparison of courts and agencies viewed in isolation, systems theory models the interactions between [*389] multiple institutions as a network of feedback loops that collectively contribute to regulatory governance.11 These institutions include not only courts, agencies, and legislatures, but also media organizations, advocacy groups, insurance underwriters, and industry trade associations all of which play a role in regulatory governance. Thus, systems theory shifts the unit of analysis from individual institutions to the regulatory system as a whole, and the theory evaluates each institution with an appreciation for the role it plays as a constituent part of that system.
Tort law's impact on regulation is highly contextual.12 Consequently, drawing inferences from detailed study of individual cases is likely to yield more accurate and useful insights than starting with general theories about law and economics or the separation of powers.13 With this in mind, this Article grounds its theoretical claims in a case study of tort litigation's role in addressing the most urgent food safety problem currently facing U.S. consumers: food poisoning outbreaks caused by leafy greens contaminated with virulent microbial pathogens. Part II describes how tort litigation has played a vital role in the development of government regulations and industry standards that govern food safety in the leafy greens industry. The analysis reveals how the interaction of lawsuits, media coverage, consumer advocacy, and public outrage has shaped and motivated efforts by government officials and industry leaders to reduce the risk of microbial contamination in growing fields and processing plants. Part III harvests insights from this case study to develop a general theory of the interdependence of litigation and government regulation. The theory explains how lawsuits provide a leverage point within regulatory governance systems that can enhance regulatory performance, bolster political legitimacy, and foster feedback and learning.
This Article does not aim to champion tort law as a useful strategy for advancing regulatory policy in every situation. Instead, the goal is to highlight the interdependence of litigation and regulation an aspect of the current debate over
9 Kysar, supra note 7, at 3 (arguing that the strengths of tort litigation become apparent when viewed "as part of a larger ecosystem of governance institutions"); Kysar & Reynolds, supra note 8, at 1 (situating tort within society's "ecosystem of risk regulation"); TIMOTHY D. LYTTON, OUTBREAK: FOODBORNE ILLNESS AND THE STRUGGLE FOR FOOD SAFETY 152- 61, 195-200 (2019) [hereinafter LYTTON, OUTBREAK] (analyzing food safety litigation as part of a system of regulatory governance).
10 See Schuck, supra note 4, at 227-30 (exemplifying the use of comparative institutional analysis in assessing the regulatory impact of tort litigation). Compare LYTTON, OUTBREAK, supra note 9, at 174-76 (discussing the shortcomings of comparative institutional analysis as applied to tort litigation). See generally Kysar & Reynolds, supra note 8 (offering a more integrated, empirical alternative to abstract comparative analysis of regulatory governance institutions).
11 For a more detailed definition of a system and an introduction to systems theory, see infra Part III.A.
12 See generally Viscusi, supra note 1, at 1 (analyzing the impact of tobacco, gun, lead-paint, medical device, and insurance litigation on regulatory policies); MORRISS ET AL., supra note 1 (examining regulation-by-litigation in heavy-duty diesel-engine, asbestos, and tobacco litigation); Kessler, supra note 1 (compiling empirical studies in public health, financial markets, medical care, and workplace safety); Lytton, Using Tort Litigation, supra note 8 (providing multiple case studies evaluating the benefits and costs of using litigation to advance regulatory policy).
13 Timothy D. Lytton, Using Litigation to Make Public Health Policy: Theoretical and Empirical Challenges in Assessing Produce Liability, Tobacco, and Gun Litigation, 32 J. L. MED. & ETHICS 556, 563 (arguing that much of the debate over the use of tort litigation to advance regulatory policy is driven by ideology and unsupported by empirical evidence).
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regulation by litigation that is not well accounted [*390] for by comparative institutional analysis. Systems theory provides a new language to describe this interdependence that will be useful to careful critics and defenders alike. II. FOOD SAFETY REGULATION IN THE LEAFY GREENS INDUSTRY
Foodborne illness is a serious public health problem. The Centers for Disease Control and Prevention ("CDC") estimates that contaminated food causes forty-eight million cases of acute gastroenteritis each year, resulting in 128,000 hospitalizations, 3,000 deaths, and $1.8 billion in healthcare costs.14 More than twice as many Americans are sickened every year by foodborne pathogens than contracted coronavirus in 2020.15 Nearly six times as many Americans are hospitalized annually for food poisoning as are admitted for gunshot wounds.16 More than double the number of Americans fall victim to foodborne illness each year than suffer injuries from traffic accidents, falls, cuts, natural disasters, cycling, poisoning, and burns combined.17
Surprisingly, fresh produce often considered the healthiest of foods poses the greatest risk. Contaminated fruits and vegetables account for more sickness than any other single category of food.18 And among fresh produce, leafy greens are the most notorious source of foodborne illness outbreaks.19 By one estimate, contaminated leafy greens [*391] cause 2.3 million illnesses every year at an annual economic cost of $5.2 billion.20 Romaine lettuce alone
14 Estimates of Foodborne Illness in the United States, CDC (Nov. 5, 2018), https://www.cdc.gov/foodborneburden/2011- foodborne-estimates.html [https://perma.cc/8BX8-VQ7B]; SANDRA HOFFMANN ET AL., ECON. RSCH. SERV., U.S. DEP'T OF AGRIC., EIB-140, ECONOMIC BURDEN OF MAJOR FOODBORNE ILLNESSES ACQUIRED IN THE UNITED STATES 11 (2015), https://www.ers.usda.gov/webdocs/publications/43984/52807_eib140.pdf [https://perma.cc/77TZ-E3NM].
15 COVID Data Tracker, CDC, https://covid.cdc.gov/covid-data-tracker/#datatracker-home [https://perma.cc/2KNM-93A7] (last visited Jan. 1, 2021) (reporting 19,663,976 total COVID-19 cases in the United States between January 21, 2020, and December 31, 2020).
16 LYTTON, OUTBREAK, supra note 9, at 5.
17 Id. at 6.
18 Nils Fischer et al., A Review of Foodborne Illness in the U.S. from 2004-2013, OUTBREAK ALERT! 2015 (2015), https://www.cspinet.org/sites/default/files/attachment/outbreak-alert-2015.pdf [https://perma.cc/UM5X-4EUW] ("Produce caused more illnesses than any other food category and had the largest number of outbreaks for any single food category.").
19 Lisa Gill, 10 Risky Recalled Foods You Should Know About, CONSUMER REPS. (Mar. 30, 2023), https://www.consumerreports.org/health/food-recalls/risky-recalledfoods-you-should-know-about-a4109713872/ [https://perma.cc/SNL9-VZDG] (listing leafy greens first in a ranking of 10 foods linked to serious food safety recalls and foodborne illness outbreaks); INT'L COMM'N ON MICROBIOLOGICAL SPECIFICATIONS FOR FOODS, MICROORGANISMS IN FOODS 7, at 386 (2d ed. 2018) (reporting that an international panel of experts convened by the Codex Alimentarius Commission concluded that "control of pathogens on RTE [(ready to eat)] leafy vegetable products was of highest concern among all produce categories"). Since 1983, public health officials have attributed 110 U.S. foodborne illness outbreaks to contaminated leafy greens. Bill Marler, FOODBORNE ILLNESS OUTBREAK DATABASE, https://outbreakdatabase.com/ [https://perma.cc/5PTH-PHW6] (last visited May 18, 2023); see also News Desk, Almost 6 Dozen Outbreaks Traced to Leafy Greens Since 1995, FOOD SAFETY NEWS (Apr. 20, 2018), https://www.foodsafetynews.com/2018/04/almost-6-dozen- outbreaks-traced-to-leafy-greens-since-1995/ [https://perma.cc/TPV7-8GP4] (listing 78 outbreaks between 1995 and 2017); Katherine E. Marshall et al., Lessons Learned from a Decade of Investigations of Shiga Toxin-Producing Escherichia coli Outbreaks Linked to Leafy Greens, United States and Canada, 26 EMERGING INFECTIOUS DISEASES 2320 (2020) (analyzing 40 outbreaks of Enterohemorrhagic E. coli illness linked to leafy greens between 2009 and 2018); Kevin Loria, Leafy Greens Safety Guide: In an Age of Rampant Romaine Contamination, Can Our Salads be Saved?, CONSUMER REPORTS (Jan. 27, 2020), https://www.consumerreports.org/food-safety/leafy-greens-safety-guide/ [https://perma.cc/V425-GGGB] (reporting 46 E. coli outbreaks traced to leafy greens between 2006 and 2019). Between 2014 and 2021 alone, the CDC identified 78 outbreaks involving 2,028 illnesses, 477 hospitalizations, and 18 deaths from tainted lettuce, spinach, and kale. Lettuce, Other Leafy Greens, and Food Safety, CDC (Apr. 26, 2023), https://www.cdc.gov/foodsafety/communication/leafy- greens.html [https://perma.cc/FU78-M79X].
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now accounts for twenty percent of E. coli O157:H7 illnesses roughly equal to the rate for contaminated beef.21 Leafy greens are also frequently responsible for illnesses caused by other strains of toxic E. coli, as well as Salmonella, Listeria monocytogenes, Cyclospora, and norovirus.22 Investigations have traced many outbreaks to farms in California and Arizona, where growers cultivate ninety-five percent of leafy greens sold in the United States.23 Recurrent outbreaks [*392] have cost the industry hundreds of millions of dollars,24 and a growing number of consumers has become, understandably, wary of eating lettuce.25
Fresh produce presents unique food safety challenges. To begin with, fruits and vegetables are typically grown outdoors, where they are exposed to insects, birds, other wildlife, particulates in the air, and, in the case of vegetable row crops, stormwater runoff from neighboring properties.26 All of these are potential sources of microbial contamination.27 Moreover, the [*393] most common "kill steps" used to neutralize harmful foodborne pathogens
20 Xuerui Yang & Robert Scharff, Foodborne Illness from Leafy Greens in the United States: Attribution, Burden, Cost, 87 J. FOOD PROTEC., Apr. 10, 2024, at 4, 6.
21 Id. at 1 ("19.8% of Shiga toxin-producing Escherichia coli O157:H7 illnesses are associated with romaine among all food commodities . . . ."); INTERAGENCY FOOD SAFETY ANALYTICS COLLABORATION, FOODBORNE ILLNESS SOURCE ATTRIBUTION ESTIMATES FOR 2020 FOR SALMONELLA, ESCHERICHIA COLI O157, AND LISTERIA MONOCYTOGENES USING MULTI-YEAR OUTBREAK SURVEILLANCE DATA, UNITED STATES, at 9 (2022) (attributing 22.8% of E. coli O157 illnesses to beef).
22 CDC, Lettuce, Other Leafy Greens, and Food Safety, supra note 19. According to one estimate, contaminated leafy greens cause more than 18,000 enterohemorrhagic E. coli infections in the U.S. each year. INT'L COMM'N, supra note 19, at 393.
23 See, e.g., 2019 E. coli Outbreak Linked to Romaine Lettuce, CDC (Jan. 15, 2020), https://www.cdc.gov/ecoli/2019/o157h7-11- 19/index.html [https://perma.cc/24RX-DLUN] (outbreak traced to Salinas Valley growing region in California); FDA Investigated Multistate Outbreak of E. coli O157:H7 Infections Linked to Romaine Lettuce from Yuma Growing Region, FDA (Nov. 1, 2018), https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigated-multistate-outbreak-e-coli-o157h7-inf ections-linked- romaine-lettuce-yuma-growing [https://perma.cc/28LV-W48D] (outbreak traced to Yuma Valley growing region in Arizona); Off. of Pub. Affs., A Look at Year-Round Lettuce Production - From California's Leafy Greens Marketing Agreement, CAL. DEP'T OF FOOD AND AGRIC.: PLANTING SEEDS BLOG (Oct. 24, 2017), https://plantingseedsblog.cdfa.ca.gov/wordpress/?p=13929 [https://perma.cc/25JNDTDJ] (estimating that growers in California and Arizona produce 95 percent of U.S. leafy green crops).
24 See KRISTIN KIESEL ET AL., E. COLI IN THE ROMAINE LETTUCE INDUSTRY: ECONOMIC IMPACTS FROM THE NOVEMBER 2018 OUTBREAK, at 3 (2021) (estimating the total social loss throughout the supply chain between $280 and $350 million); see also Food Safety: Current Challenges and New Ideas to Safeguard Consumers: Hearing Before the S. Comm. on Health, Educ., Lab., and Pensions, 109th Cong. 71 (2006) (testimony of fresh produce food safety expert Robert Whitaker estimating industry losses from the 2006 Dole baby spinach outbreak at $100 million).
25 Loria, supra note 19 (citing a nationally representative 2019 Consumer Reports survey finding that fifty-two percent of 1,003 Americans surveyed "admitted being concerned about getting sick from leafy greens more than those who are worried about poisonings from beef, chicken, or eggs" and describing a decline in romaine lettuce sales following outbreaks in 2018).
26 Susan Bach & Pascal Delaquis, The Origin and Spread of Human Pathogens in Fruit Production Systems, in MICROBIAL SAFETY OF FRESH PRODUCE 45-46 (Xuetong Fan ed., 2009).
27 Some producers have touted greenhouse cultivation, which greatly reduces exposure to microbial contaminants. Coalition Launches Food Safety Program for Indoor-Grown Leafy Greens, FOOD SAFETY NEWS (Apr. 29, 2021), https://www.foodsafetynews.com/2021/04/coalition-launches-food-safety-program-for-indoor-grown-leafy-greens/ [https://perma.cc/UA2W-S7DL]. But despite steady technological advances and increasing consumer demand, greenhouses will not be capable anytime soon of production on a scale necessary to replace outdoor cultivation. Cookson Beecher, Safety Aspects of Indoor Farming Signal a Change in Agriculture, FOOD SAFETY NEWS (Feb. 24, 2020), https://www.foodsafetynews.com/2020/02/safetyaspects-of-indoor-farming-signal-a-change-in-agriculture/ [https://perma.cc/ED27-GY4Y]. Moreover, even greenhouses have been found to harbor harmful pathogens. Foodborne Illness Strain of E. coli Found in Hydroponic and Aquaponic Food Production, Indicating Need for Food Safety Monitoring, ORGANIC CTR. (July 20, 2020), https://www.organic-center.org/research/foodborne-illness-strain-e-coli-found-hydroponic-and-aquaponic-
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during processing pasteurization, canning, cooking, and freezing destroy products like lettuce that consumers wish to eat raw.28
A. Regulatory Standards
Food safety efforts directly address these challenges at both preharvest and post-harvest stages of production. Pre- harvest interventions attempt to prevent microbial contamination in growing fields.29 These include testing water quality and organic fertilizers and taking remedial measures where samples exceed specific thresholds for microbial contaminants; clearing buffer zones and constructing barriers to prevent animal intrusion, water runoff, and dust migration into fields; training fieldworkers to practice good personal hygiene and sanitize farm vehicles and harvesting equipment; and distancing growing operations from cattle grazing and feedlots.30 Post-harvest measures aim to neutralize pathogens during processing. For example, processors wash products with [*394] chlorinated water,31 treat them with ozone gas,32 irradiate them,33 blow cold plasma over them,34 and expose them to ultraviolet or blue light.35 Refrigeration also retards pathogen growth.36
food-production-indicating [https://perma.cc/BSX6-U9XX]; CDC, Lettuce, Other Leafy Greens, and Food Safety, supra note 19. Aquaponic and hydroponic production can mitigate some microbial hazards. News Desk, Association Contends Aquaponics Offer a Solution to Some Food Safety Issues, FOOD SAFETY NEWS (June 22, 2021), https://www.foodsafetynews.com/2021/06/association-contends-aquaponics-offer-a-solution-to-some-food-safety- issues/#google_vignette [https://perma.cc/PLJ9-SMU9]. However, aquaponic and hydroponic growing systems are not immune from the hazard of microbial contamination. News Desk, Aquaponic and Hydroponic Systems Are No Escape From E. coli Contamination, FOOD SAFETY NEWS (April 22, 2020), https://www.foodsafetynews.com/2020/04/aquaponic-and-hydroponic- systems-are-no-escape-from-e-coli-contamination/ [https://perma.cc/X6FF-KJN5].
28 Why Experts Say the "Kill-Step" Is So Important to Food Quality Control, ACAD. OF APPLIED PHARM. SCIS. (Aug. 20, 2019), https://www.aaps.ca/blog/whyexperts-say-the-kill-step-is-so-important-to-food-quality-control [https://perma.cc/2 FWN-JBWA].
29 See, e.g., Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 80 Fed. Reg. 74353, 74355 (Nov. 27, 2015) (to be codified at 21 C.F.R. pts. 11, 16, 112) [hereinafter Produce Safety Rule].
30 Id. at 74356; CAL. LEAFY GREENS MKTG. AGREEMENT, COMMODITY SPECIFIC FOOD SAFETY GUIDELINES 19 (2023), https://assets.lgma.ca.gov/downloads/CURRENT-PUBLISHED-VERSION_CA-LGMA-Metrics_2023.09.20_FINAL.pdf [https://perma.cc/B7WZ-L9EE].
31 Trevor Suslow, Postharvest Chlorination: Basic Properties & Key Points for Effective Disinfection, UNIV. OF CAL. AGRIC. AND NAT. RES. 1 (1997), https://anrcatalog.ucanr.edu/pdf/8003.pdf [https://perma.cc/GE7N-ZDXY]. Washing fresh produce with chlorinated water reduces pathogen levels but is not 100 percent effective. Indeed, if not properly monitored, wash water can be a vehicle for cross contamination. See Julie Schmit, Tainted Spinach: All Bacteria May Not Come Out in the Wash, USA TODAY (Oct. 5, 2006), https://usatoday30.usatoday.com/money/industries/food/2006-10-04-spinach-wash-usat_x.htm [https://perma.cc/9V52-T2CT]; Roy Costa, The Packinghouse: Safety and Uses of Process-Water, FOOD SAFETY NEWS (Mar. 18, 2015), https://www.foodsafetynews.com/2015/03/the-packinghousesafety-and-uses-of-process-water/ [https://perma.cc/MM6S-AKLR]; 2014 CPS Research Symposium Key Learnings, CTR. FOR PRODUCE SAFETY 9 (2014), https://www.centerforproducesafety.org/uploads/files/uploads/files/Key-Learnings/2014-CPS-Research-Symposium-Key- Learnings-updated-080424.pdf [https://perma.cc/4FKP-4FBY]; Callum J. Highmore et al., Viable-but-Nonculturable Listeria monocytogenes and Salmonella enterica Serovar Thompson Induced by Chlorine Stress Remain Infectious, 9 MBIO, Apr. 17, 2018.
32 See generally Rinaldo Botondi et al., A Review into the Effectiveness of Ozone Technology for Improving the Safety and Preserving the Quality of Fresh-Cut Fruits and Vegetables, 10 FOODS 748 (2021).
33 Although irradiation reduces pathogen levels, it has not been widely adopted because the necessary equipment is expensive, and companies fear that many consumers will not purchase irradiated food. MARION NESTLE, SAFE FOOD: THE POLITICS OF FOOD SAFETY 121-26 (Darra Goldstein ed., 2d ed. 2010); Xuetong Fan et al., Irradiation of Fresh Fruits and Vegetables, FOOD TECH. MAG. (Mar. 1, 2008), https://www.ift.org/news-and-publications/food-technology- magazine/issues/2008/march/features/irradiation-of-fresh-fruits-and-vegetables [https://perma.cc/CM9G-88MJ]; Marta Zlotnick et al., Foodborne Disease Outbreaks Linked to Foods Eligible for Irradiation, United States, 2009-2020, 30 EMERGING INFECTIOUS DISEASES 1291 (2024).
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Laboratory and field studies suggest that both pre-harvest interventions and post-harvest measures can reduce opportunities for contamination and decrease microbial loads on leafy greens.37 On this [*395] basis, government regulations and industry supply chain requirements have imposed increasingly stringent standards on growers and processors.38 This rachet-like quality of leafy greens regulation has emerged because recurring outbreaks create pressure for additional efforts to reduce contamination in the field and neutralize it in processing facilities. Part II.B maps the institutional dynamics that translate outbreaks into food safety standards. B. Institutional Dynamics
Complex interactions between a constellation of public and private actors motivated by a mix of economic, political, and legal incentives are the engine that cranks this regulatory ratchet. Successful outbreak investigations by public health officials are the catalyst for these interactions. They set in motion three initial dynamics.
First, foodborne illness outbreaks frequently attract media coverage. Newsmaking is a business that depends on advertising revenue, where advertising rates are based on readership.39 Consequently, news organizations seek stories that will attract a broad audience. Media scholars have identified criteria that journalists and their editors use in selecting and framing news stories based on their perception of what readers want. These criteria define what makes a story newsworthy. Stories that are newsworthy portray dramatic narratives depicting events of great magnitude, are novel enough to attract readers' attention but sufficiently familiar that they do not require readers to think too hard, imply a clear moral lesson, and feature well-known elites.40 Stories about natural disasters, mass shootings, and corporate scandals fit these criteria and are regularly featured in the news. So, too, do multistate foodborne illness outbreaks. News stories about outbreaks frequently feature the sudden onset of severe illness requiring hospitalization and sometimes ending in death.41 The number of victims, the geographical scope, the [*396] hospitalization rate, and the death toll lend such stories notable magnitude.42 While the details of each
34 Brendan A. Niemira, Cold Plasma Processing for Food Safety, FOOD SAFETY NEWS (June 3, 2024), https://www.foodsafetynews.com/2024/06/cold-plasma-processing-for-food-safety [https://perma.cc/ZZ3N-D5AT].
35 Three Technologies with Multiple Applications!, CPS RSCH. REP. (May 25, 2022), https://myemail.constantcontact.com/CPS- 2022-Produce-Research-Report--May.html?soid=1103350874923&aid=5HCCo1gmdL4 [https://perma.cc/9VDD-5TZV].
36 Refrigeration and Food Safety, USDA, https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety- basics/refrigeration [https://perma.cc/93K7-7NDY] (last visited Jan. 26, 2024).
37 Travis Minor & Matt Parrett, The Economic Impact of the Food and Drug Administration's Final Juice HACCP Rule, 68 FOOD POL'Y 206, 210-11 (2017) (citing studies assessing the impact of regulatory interventions on the microbiological quality of foods).
38 See infra notes 63-93 and accompanying text.
39 MICHAEL SCHUDSON, THE SOCIOLOGY OF NEWS 109-26 (2d ed. 2011).
40 Id. at 42, 172-73; HERBERT GANS, DECIDING WHAT'S NEWS: A STUDY OF THE CBS EVENING NEWS, NBC NIGHTLY NEWS, NEWSWEEK, AND TIME 22, 150, 168, 171 (David Abrahamson ed., Nw. Univ. Press, 25th anniv. ed. 2004); Johan Galtung & Mari Ruge, Structuring and Selecting the News, in THE MANUFACTURE OF NEWS: SOCIAL PROBLEMS, DEVIANCE, AND THE MASS MEDIA 54 (Stanley Cohen & Jock Young eds., rev. ed. 1981).
41 E.g., Parker Woman's 48-Year-Old Mother Latest Victim of Listeria Outbreak, CBS NEWS COLO. (Sept. 20, 2011, 6:07 PM), https://www.cbsnews.com/colorado/news/parker-womans-48-year-old-mother-latest-victim-of-listeria-outbreak/ [https://perma.cc/ZVS3-C7Z3] (reporting the death of a woman from Listeriosis linked to contaminated cantaloupe); Cathy Bussewitz, One Person Dies, Dozens Sickened after Eating Carrots Contaminated with E. coli, PBS NEWS (Nov. 17, 2024, 6:04 PM), https://www.pbs.org/newshour/health/one-person-dies-dozens-sickenedafter-eating-carrots-contaminated-with-e-coli [https://perma.cc/GC9B-NESN].
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outbreak are novel, the general outlines of outbreaks are familiar to readers. Outbreaks often feature egregious mistakes or conscious wrongdoing by well-known corporations or popular brands.43
Second, foodborne illness outbreaks generate tort claims.44 As a general rule, the sellers of tainted food products are strictly liable for any resulting consumer injuries.45 As soon as public health authorities link an outbreak to a specific product, plaintiffs' attorneys have the evidence of contamination and causation that they need to prove a claim of breach of implied warranty or manufacturing defect.46
Third, foodborne illness outbreaks frequently prompt the U.S. Food and Drug Administration ("FDA") to publish warning letters to consumers in press releases.47 Once public health authorities have identified an outbreak and linked it to a food vehicle, the FDA typically instructs consumers not to purchase or consume that food.48 The scope of such [*397] warnings varies from specific lots or brands to entire product lines, such as all raw spinach.49 Figure 1 depicts these three initial dynamics.
Figure 1. The Initial Dynamics of Leafy Greens Regulation
Several feedback loops between these three initial dynamics magnify them. Media coverage increases tort litigation by alerting plaintiffs' attorneys of an outbreak and raising awareness among victims who may seek legal redress once a news story informs them of the cause of their illness.50 In turn, tort litigation increases media coverage. The
42 E.g., Robert Anglen, U.S. Government Says All Romaine Lettuce is Unsafe and to Throw It Out, AZCENTRAL (Nov. 28, 2018, 2:21 PM), https://www.azcentral.com/story/news/local/arizona-investigations/2018/11/20/cdc-says-all-romaine-lettuce-unsafe- and-throw-out/2071222002/ [https://perma.cc/L9F2-BFRD].
43 E.g., Jessica Guynn, Chipotle Mexican Grill Agrees to $25 Million Fine to Settle Federal Criminal Charges Over Tainted Food, USA TODAY (Apr. 21, 2020, 4:25 PM), https://www.usatoday.com/story/money/2020/04/21/chipotle-outbreakfood-chain-hit- record-fine-over-tainted-food/2999607001/ [https://perma.cc/J4GD-ZK4Y].
44 E.g., LYTTON, OUTBREAK, supra note 9, at 13, 96-97, 147-48 (detailing tort litigation arising out of the 1994 outbreak of E. coli O157:H7 illness traced back to Jack-in-the-Box hamburgers, the 2006 outbreak of E. coli O157:H7 illness traced back to Dole baby spinach, and the 2011 outbreak of Listeria monocytogenes illness traced back to Jensen Farms cantaloupe).
45 Id. at 247-50 (surveying legal doctrines governing liability for foodborne illness and litigation dynamics).
46 Id. at 13, 97, 147-48 (providing examples of how public health officials provide plaintiffs' attorneys with essential information for establishing causation and filing claims).
47 E.g., Press Release, FDA, Statement on Foodborne E. coli O157:H7 Outbreak in Spinach (Sept. 26, 2006), https://web.archive.org/web/20121101021354/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm1087 43.htm [https://perma.cc/2N64-NLYA].
48 Id.
49 See Bill Marler, FDA and the Need for Transparency The FDA as "Chicken Little," MARLER CLARK (June 11, 2018), https://www.marlerblog.com/lawyeroped/fda-and-the-need-for-transparency-the-fda-as-chicken-little/ [https://perma.cc/F7ZP- BZ7P] (criticizing the reticence of the FDA to publish specific information about the source of outbreaks).
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filing of a lawsuit in response to an outbreak is itself newsworthy, and subsequent stages in the litigation process preliminary motions, revelations during discovery, testimony at trial, jury verdicts, appeals, and settlements attract ongoing episodic media coverage that can last years.51 In newsroom jargon, such a story has "legs."52 In the age of social media, foodborne illness outbreaks and subsequent litigation often generate memes.53
Media coverage and FDA warnings also interact in a mutually reinforcing feedback loop. FDA warnings published in press releases are designed to and do generate media coverage. In turn, ongoing media coverage pressures the agency to provide ongoing updates through additional warning letters detailing its efforts to investigate and stem an outbreak.54
[*398] Another feedback loop exists between tort litigation and the mobilization of outbreak survivors and their family members. Survivors and their families often come to know one another through the litigation process, especially if they are represented by the same attorney or bring claims against the same defendant.55 The experience of asserting their legal rights by pursuing tort claims has inspired some to establish or join advocacy organizations.56 In turn, these organizations often encourage foodborne illness victims and their families to pursue litigation, and they refer clients to plaintiffs' attorneys who, in turn, often make generous donations to the advocacy organizations.57
An additional feedback loop occurs between media coverage and consumer advocacy. Media coverage provides consumer advocacy groups with information they use in their educational campaigns and lobbying efforts.58 In turn, consumer advocacy groups publish reports, testify before Congress, and petition agencies, and they publicize these activities through press releases that generate media coverage.59 Social media has made it even easier for consumer advocates to obtain new information and publicize their efforts.60
A final feedback loop takes place between tort litigation and liability insurance. The threat of tort litigation incentivizes produce growers and processors to obtain liability insurance.61 In turn, the availability of insurance coverage incentivizes plaintiffs' attorneys to file lawsuits.62 Figure 2 depicts these various feedback loops.
50 LYTTON, OUTBREAK, supra note 9, at 97.
51 Id.
52 SCHUDSON, supra note 39, at 174.
53 Darin Detwiler, How Food Safety and Social Media Intersect, QUALITY ASSURANCE & FOOD SAFETY MAG. (Apr. 4, 2022), https://www.qualityassurancemag.com/article/social-studies/ [https://perma.cc/B94Q-JUNH].
54 E.g., LYTTON, OUTBREAK, supra note 9, at 118-19.
55 Id. at 98, 170.
56 Id.
57 E.g., Bill Marler, Publisher's Platform: Marler Clark Donates $100,000 to Dave Theno Scholarship at Stop Foodborne Illness, FOOD SAFETY NEWS (Jan. 4, 2020), https://www.foodsafetynews.com/2020/01/publishers-platform-marler-clarkdonates- 100000-to-dave-theno-scholarship-at-stop-foodborne-illness/ [https://perma.cc/3G5B-C83N].
58 LYTTON, OUTBREAK, supra note 9, at 120.
59 E.g., Mark Charter, Consumer Reports: Safest Way to Eat Leafy Greens, KGUN TUCSON (Mar. 18, 2020, 7:17 AM), https://www.kgun9.com/money/consumer/consumer-reports-safest-way-to-eat-leafy-greens [https://perma.cc/D5KC-68YX] (detailing local television news coverage of consumer advocacy organization report on foodborne illness outbreaks linked to leafy greens).
60 Detwiler, supra note 53.
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[*399] Figure 2. Feedback Loops in Leafy Greens Regulation
These various feedback loops magnify the pressure for new and more stringent food safety standards.63 Before describing how these sources of pressure effect policy change, it will be helpful to introduce the three institutional pillars of food safety governance in the leafy greens industry and the standards associated with them. These three pillars are marketing agreements among leafy greens producers, private food safety audits required by large retail buyers, and FDA regulations.
The California Leafy Greens Marketing Agreement ("LGMA") implements pre-harvest safeguards.64 The LGMA is a voluntary program in which handlers entities that process, pack, ship, or distribute leafy greens earn the right to display a food safety seal of approval on their products if they source them exclusively from farms that pass rigorous food safety audits conducted by state inspectors under standards developed by industry technical committees.65 Handlers responsible for more than ninety-nine percent of California's leafy greens production are members of the LGMA.66 A similar marketing agreement governs the Arizona leafy greens industry.67 Both programs regularly update their [*400] requirements in an effort to achieve continual improvement.68 California and Arizona farms undergo LGMA audits four times per year.69 One audit is unannounced, and the others occur
61 Timothy D. Lytton, Using Insurance to Regulate Food Safety: Field Notes from the Fresh Produce Sector, 52 N.M. L. REV. 282, 313-17 (2022) [hereinafter Lytton, Using Insurance] (describing various forms of liability insurance covering fresh produce farms and processing facilities).
62 See Kenneth S. Abraham & Catherine M. Sharkey, The Glaring Gap in Tort Theory, 133 YALE L. J. (forthcoming 2024) (detailing how the availability of liability insurance has led to the expansion of tort liability); Tom Baker, Liability Insurance as Tort Regulation: Six Ways that Liability Insurance Shapes Tort Law in Action, 12 CONN. INS. L.J. 1 (2005) (analyzing ways in which liability insurance coverage facilitates and shapes tort claims).
63 LYTTON, OUTBREAK, supra note 9, at 147-52.
64 Id. at 133-41, 176, 251-56 (detailing the history and structure of the California LGMA); Timothy D. Lytton, Technical Standards in Health and Safety Regulation: Risk Regimes, the New Administrative Law, and Food Safety Governance, in 2 CAMBRIDGE HANDBOOK OF TECHNICAL STANDARDIZATION LAW, 45, 50-54 (Jorge L. Contreras ed., 2019) [hereinafter Lytton, Technical Standards] (analyzing the rulemaking process of the California LGMA).
65 LYTTON, OUTBREAK, supra note 9, at 135-36, 176.
66 Dan Flynn, LGMA Policing 99 Percent of Market, FOOD SAFETY NEWS (Nov. 11, 2009), https://www.foodsafetynews.com/?s=lgma+policing+99+percent+of+market#google_vignette [https://perma.cc/PJ3L-GEGE].
67 Protecting Public Health, ARIZ. LGMA, https://www.arizonaleafygreens.org/about-us [https://perma.cc/T8HG-EE3B] (last visited Jan. 28, 2024).
68 E.g., April Ward, Food Safety Evolution, CAL. LGMA (Nov. 21, 2022), https://lgma.ca.gov/news/food-safety-evolution [https://perma.cc/A2CP-LRE3].
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every two months during active harvesting.70 Annual LGMA reports document high rates of compliance among growers, and independent surveys indicate that the LGMA has prompted growers to invest more in food safety precautions.71
In addition to the LGMA, large commercial buyers of fresh produce supermarkets, restaurant chains, and food service companies require growers and processors from whom they source leafy greens to pass food safety audits based on schemes developed by industry technical committees and private food safety entities.72 Independent third-party auditing firms conduct the audits.73 Food safety audits required by buyers typically occur annually or once every three years, depending on the audit scheme, and some schemes require interim surveillance audits.74 Whereas LGMA audits are conducted by state inspectors and paid for by handlers, audits required by buyers are typically conducted by private firms paid directly by the farms being audited.75 This type of arrangement creates a conflict of interest since auditors seeking to attract or retain accounts may reduce the rigor of their inspections or inflate audit scores to please growers and processors.76 A complex private governance regime has arisen to address concerns about such conflicts of interest and the reliability of private third-party food safety audits on farms.77 The [*401] Consumer Goods Forum, an international trade association of major retailers, has implemented a benchmarking system known as the Global Food Safety Initiative ("GFSI") that imposes minimum standards on food safety audit schemes.78 Many buyers accept only audits conducted by accredited audit firms using food safety schemes that conform to GFSI standards.79
Finally, FDA regulations and guidance also govern the leafy greens industry. The agency's 2015 Produce Safety Rule ("PSR"), published as part of a larger food safety overhaul authorized by the Food Safety Modernization Act of 2010 ("FSMA"), imposes requirements on growers that are largely derivative of the LGMA's rigorous standards.80
69 CAL. LGMA, 2020/2021 ANNUAL REPORT 10 (2021), https://assets.lgma.ca.gov/downloads/LGMA-AnnualReport-20-21.pdf [https://perma.cc/T3Y3-TDXS].
70 Id.
71 LYTTON, OUTBREAK supra note 9, at 163-64; see GREGORY ASTIL ET AL., ECON. RSCH. SERV., EIB-210, U.S. PRODUCE GROWERS' DECISIONMAKING UNDER EVOLVING FOOD SAFETY STANDARDS, at iv (2019) (finding that growers invested in food safety measures due to competitive market pressures despite uncertainty about the benefits in terms of risk reduction).
72 LYTTON, OUTBREAK, supra note 9, at 127-30, 251-52 (describing the history and current infrastructure of private food safety auditing).
73 Id.
74 Megan Crivelli, How is Produce Regulated?, THE PRODUCE NERD (Feb. 28, 2017), https://www.theproducenerd.com/2017/02/how-is-your-produce-regulated/ [https://perma.cc/YVP6-5GNM].
75 LYTTON, OUTBREAK, supra note 9, at 208-10.
76 Timothy D. Lytton & Leslie K. McAllister, Oversight in Private Food Safety Auditing: Addressing Auditor Conflict of Interest, 2014 WISC. L. REV. 297-304 (2014) (analyzing conflict of interest in private food safety auditing).
77 Id. at 304-34 (surveying methods of reducing conflict of interest in private food safety auditing); see Timothy D. Lytton, The Taming of the Stew: Regulatory Intermediaries in Food Safety Governance, 670 ANNALS AM. ACAD. POL. & SOC. SCI. 78 (2017) (describing the emergence of intermediaries to address agency problems in private food safety auditing).
78 Harmonization, GLOBAL FOOD SAFETY INITIATIVE: THE CONSUMER GOODS FORUM, https://mygfsi.com/what-we- do/harmonisation/ [https://perma.cc/KQX8-HCVC] (last visited Jan. 28, 2024); LYTTON, OUTBREAK, supra note 9, at 130-33.
79 Tiffany M. Donica, A Guide to GFSI Compliance and Certification, SAFETYCHAIN (Sept. 5, 2020), https://safetychain.com/blog/gfsi-compliance-certification [https://perma.cc/HA46-FUJ5].
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The PSR also establishes standards for the use of antimicrobial agents in postharvest washing of produce.81 Historically, limited resources have precluded routine FDA inspection of fresh produce farms.82 However, in 2019, the FDA launched a program to partner with state agencies to inspect high-risk growing operations, such as farms located near cattle feeding operations or in watersheds likely to convey contaminated runoff water from areas populated by domestic or wild animals.83
Pressure from various sources has contributed to the establishment and ongoing evolution of the LGMA, the GFSI, and the PSR. A key step in the process occurs when media coverage, FDA warnings, and consumer advocacy generate and sustain consumer anxiety. Since the late 1990s, consumer wariness of purchasing fresh produce associated with outbreaks [*402] has been a consistent economic incentive spurring large commercial buyers to sponsor through their trade associations the development of the private food safety schemes and auditors that currently operate under the GFSI umbrella.84 In the wake of a nationwide 2006 outbreak traced back to baby spinach grown and processed in California, a precipitous drop in consumer demand motivated major producers to establish the LGMA.85 Subsequent outbreaks caused by contaminated leafy greens have similarly motivated revisions to make the LGMA metrics more stringent.86 Consumer anxiety also prompted congressional attention, leading to oversight hearings in the wake of major outbreaks and, eventually, to the passage of FSMA in 2010, which mandated that the FDA publish a produce safety rule within two-and-a-half years of passage.87 Figure 3 depicts these dynamics.
Figure 3. The Role of Consumer Dissatisfaction in Leafy Greens Regulations
80 Produce Safety Rule, 80 Fed. Reg. 74353, 74431-61 (Nov. 27, 2015) (to be codified at 21 C.F.R. pts. 11, 16, 112); 21 C.F.R. §§ 112.41-.50 (2015); LYTTON, OUTBREAK, supra note 9, at 141-44 (quoting industry and government sources regarding the influence of the LGMA on the PSR).
81 Produce Safety Rule, 80 Fed. Reg. at 74459-60, 21 C.F.R. § 112.48 (2015).
82 FDA has had jurisdiction over food safety on farms since passage of the Federal Food, Drug, and Cosmetic Act of 1938. VANESSA K. BURROWS, CONG. RSCH. SERV., RS22939, FDA AUTHORITY TO REGULATE ON-FARM ACTIVITY, at 2 (2008); see Varun Shekhar, Produce Exceptionalism: Examining the Leafy Greens Marketing Agreement and Its Ability to Improve Food Safety, 6 J. FOOD L. & POL'Y 267, 267-309 (2010). However, the agency has never conducted routine inspections on farms. LYTTON, OUTBREAK, supra note 9, at 206-07.
83 Cookson Beecher, Food-Safety Inspectors Begin Visits to Produce Farms, Packing Houses, FOOD SAFETY NEWS (Aug. 5, 2019), https://www.foodsafetynews.com/2019/08/food-safety-inspectors-begin-visits-to-produce-farms-packing-houses/ [https://perma.cc/F6VD-638J].
84 LYTTON, OUTBREAK, supra note 9, at 118-20, 127-33.
85 Id. at 133-41, 251-56.
86 Timothy D. Lytton, Known Unknowns: Unmeasurable Hazards and the Limits of Risk Regulation, 76 OKLA. L. REV. 857, 899 (2024) [hereinafter Lytton, Known Unknowns].
87 LYTTON, OUTBREAK, supra note 9, at 141-47; Lytton, Known Unknowns, supra note 86, at 891-92.
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Finally, there are other pathways of influence within the system. Consumer anxiety is not the only driver of congressional action. The mobilization of survivors and their families also plays a role, as evidenced [*403] by their prominence in oversight hearings and lobbying efforts.88 The same is true for consumer advocacy organizations, which develop ongoing relationships with individual representatives and senators.89 Similarly, congressional action was not the only source of pressure for the establishment of the LGMA and the PSR. Consumer advocacy groups successfully sued the FDA to compel it to publish the PSR after the agency missed the statutory deadline.90 In the years prior to passage of the LGMA, the FDA threatened enforcement action against growers and processors under the Food, Drug, and Cosmetic Act ("FDCA"), which imposes criminal penalties for the sale of adulterated products.91 Congressional oversight hearings in the wake of major outbreaks have subjected FDA officials to public castigation by elected officials eager to cast themselves as champions of consumer protection, which has, in turn, translated into agency pressure on leafy greens producers to increase the rigor of industry standards.92 Finally, liability insurance underwriters have played a role in incentivizing compliance with industry standards by incorporating them into their underwriting guidelines, coverage terms, and loss control
88 E.g., Andrew Bridges, Food Poisoning Victims Testify Before Congress, SARASOTA HERALD-TRIBUNE (Apr. 25, 2007), https://www.heraldtribune.com/story/news/2007/04/25/food-poisoning-victims-testify-before-congress/28543401007/ [https://perma.cc/S7L3-5ERN].
89 Press Release, Rosa DeLauro, Representative for the Third District of Connecticut, House of Representatives, Blumenthal, DeLauro Urge United States Department of Agriculture To Strengthen Department's Ability To Reduce Public Health Risks Posed By Antibiotic-Resistant Salmonella Pathogen (Feb. 27, 2015), https://delauro.house.gov/media-center/press- releases/blumenthal-delauro-urge-united-states-department-agriculture-strengthen [https://perma.cc/FE7V-KWH5] (endorsing citizen petition by the Center for Science and the Public Interest).
90 RENEE JOHNSON, CONG. RSCH. SERV., R43724, IMPLEMENTATION OF THE FDA FOOD SAFETY MODERNIZATION ACT 6-7 (2015).
91 Letter from Robert E. Brackett, Director, Center for Food Safety and Applied Nutrition, to California Firms that Grow, Pack, Process, or Ship Fresh and Fresh-cut Lettuce (Nov. 4, 2005), https://www.fda.gov/Food/FoodSafety/Product- SpecificInformation/FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/ucm118911.htm [https://perma.cc/R5LQ-TKQV].
92 E.g., Food Safety: Hearing Before a Subcomm. of the Sen. Comm. on Appropriations, 110th Cong. 2 (Mar. 12, 2007) (describing statement of Sen. Herb Kohl recounting "troublesome" facts about the FDA's food safety inspection and enforcement efforts).
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services.93 Figure 4 depicts these overlapping influences on the establishment and implementation of government regulation and industry standards.
[*404] Figure 4. Overlapping Influences in Leafy Greens Regulation
As the diagram illustrates, multiple sources and pathways of influence have combined to prompt industry standards and government regulations and support their implementation.
To summarize, foodborne illness outbreaks trigger a series of institutional dynamics. These dynamics create various economic, political, and legal incentives that have encouraged agency regulators and industry stakeholders to develop a mix of government regulations and private standards to prevent microbial contamination in the leafy greens production. This complex system of regulatory governance is depicted in Figure 5.
[*405] Figure 5. The Institutional Dynamics of Leafy Greens Regulation
93 Lytton, Using Insurance, supra note 61, at 328-33 (documenting the ways that insurance underwriters incentivize leafy greens growers to comply with food safety standards).
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It should be noted that, although successful outbreak investigations by public health officials drive food safety policy, they are very rare.94 There are several reasons for this. First, public health surveillance captures only a small proportion of foodborne illnesses.95 Most people who suffer from food poisoning do not visit a doctor. They simply wait for the symptoms to pass. When victims do seek medical attention, physicians typically offer advice and palliative care but do not request a stool sample to identify the pathogen that caused the illness. Only if a physician obtains a stool sample can a laboratory identify the pathogen responsible for that victim's illness and report it to state public health authorities.96
Second, reported cases only trigger an investigation if they can be linked as part of a single outbreak. DNA analysis of pathogenic bacterial [*406] isolates from patient stool samples enables state and federal public health authorities to identify outbreaks of illness caused by a common bacterial strain.97 Outbreak investigators interview outbreak victims to identify any common foods they ate.98 Investigators can confirm the food vehicle of the outbreak by matching the DNA of microbial isolates from patient stool samples to microbial isolates from leftover samples of common foods identified in the interviews.99 However, investigators face several challenges in attributing an outbreak to a specific food. Victims are frequently unable to recall all the foods that they consumed days or weeks earlier, especially if they are still suffering from acute illness. Moreover, by the time an investigation begins, victims have often discarded any leftovers of the food that made them sick especially old produce.100
Third, to pinpoint the root cause of an outbreak, investigators must trace the chain of custody of confirmed food vehicles backwards through the supply chain.101 Investigators take environmental samples from stores, food preparation facilities, processing plants, and farming operations in search of a microbial DNA match that identifies a source of contamination.102 This process can be especially difficult in outbreaks involving leafy greens.103 Investigators may be unable to identify the brand of unlabeled fresh produce. Moreover, leafy greens from many different growers are frequently mixed together during processing, causing cross contamination and making it difficult to trace the source of contamination to a particular farm.104
94 See LYTTON, OUTBREAK, supra note 9, at 204.
95 For a more detailed description of foodborne illness surveillance and investigation summarized in this and the following three paragraphs, see id. at 178-200. See also Steps in a Foodborne Illness Outbreak Investigation, CDC, https://perma.cc/7ZW3- FAYQ (last visited May 25, 2020); Timeline for Identifying and Reporting Illness in Foodborne Outbreaks, CDC (June 3, 2021), https://perma.cc/53QU-6FK5; JEAN C. BUZBY ET AL., ECON. RESH. SERV., AER-799, PRODUCT LIABILITY AND MICROBIAL FOODBORNE ILLNESS 3-7 (2001).
96 BUZBY ET AL., supra note 95, at 7.
97 Id. at 26.
98 Steps in a Multistate Foodborne Illness Outbreak Investigation, CDC, https://www.cdc.gov/foodborne-outbreaks/investigation- steps/index.html [https://perma.cc/MX5B-AUML] (last visited Mar. 1, 2025).
99 Id.
100 Timeline for Identifying and Reporting Illness in Foodborne Outbreaks, supra note 95 (explaining that symptoms from food poisoning may start weeks after eating contaminated food).
101 Steps in a Multistate Foodborne Illness Outbreak Investigation, supra note 97.
102 Id.
103 Id.
104 Laura G. Brown et al., Outbreak Characteristics Associated with Identification of Contributing Factors to Foodborne Illness Outbreaks, 145 EPIDEMIOLOGY & INFECTION 2254, 2254 (2017) (finding that food vehicles are more often identified when
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The difficulty of identifying the company responsible for an outbreak combined with the fact that only the most serious cases of illness, those involving permanent disability or death, could generate sufficiently large contingency fees to attract a plaintiffs' lawyer means that lawsuits against farmers and processors for foodborne illness are [*407] extremely rare. A 2001 U.S. Department of Agriculture ("USDA") report estimated that fewer than 0.01 percent of all foodborne illness cases between 1988 and 1997 gave rise to litigation.105 For the reasons explained above, the percentage is almost certainly lower for outbreaks involving fresh produce. According to one liability insurance underwriter, the chances of a farmer getting sued for an outbreak are about as likely as a lightning strike.106
Consequently, the influence of tort claims on food safety governance derives not from the volume of claims but from the function of litigation as a lever within a larger system. Building on this observation, Part III elaborates a general theory of tort litigation's role within regulatory governance systems. III. A SYSTEMS THEORY OF TORT LAW
This Part draws from the institutional dynamics of food safety governance to develop a systems theory of how tort law influences regulatory governance. The discussion begins by introducing some basic concepts from systems theory. It then applies these concepts to reframe the debate over the use of tort litigation as a means of advancing regulatory policy. A. Regulatory Governance as a Reinforcing Feedback Loop
A system is a set of interdependent elements that serves a specific purpose and achieves its purpose through feedback.107 For example, the air-conditioning system of a house is composed of an interdependent set of components thermostat, air-conditioning unit, and ducts organized in such a way as to maintain a constant temperature in the house.108 The homeowner sets the thermostat to a desired temperature. If the desired temperature is lower than the temperature as measured by the thermostat, [*408] the thermostat signals the air- conditioning unit, which causes the unit to produce cool air, which is then distributed throughout the house by the ducts. So long as there remains a negative gap between the desired temperature and the temperature as measured by the thermostat, the thermostat will continue to signal the air-conditioning unit to produce cool air. When the gap is reduced to zero, the thermostat will signal the air-conditioning unit to cease producing cool air. This cycle of feedback is represented by the diagram depicted in Figure 6.
Figure 6. Feedback Loop Diagram of an Air-Conditioning System
outbreaks are associated with high-volume food service operations subjected to environmental testing within a day of an establishment being linked to an outbreak).
105 BUZBY ET AL., supra note 95, at 3.
106 Lytton, Using Insurance, supra note 61, at 312 (quoting an anonymous underwriter).
107 Daniel H. Kim, Introduction to Systems Thinking, SYSTEMS THINKER 3, https://thesystemsthinker.com/introduction-to- systems-thinking/ [https://perma.cc/93XH-ZUWY] (last visited May 29, 2022). This and the following paragraphs introducing systems theory are drawn from Timothy D. Lytton, Private Third-Party Verification of Credence Quality Claims: The Kosher Certification Model, in RESEARCH HANDBOOK ON INTERNATIONAL FOOD LAW 22 (Michael Roberts ed., 2023). For an introduction to systems theory, see DONELLA H. MEADOWS, THINKING IN SYSTEMS (Kindle ed. 2008) and Kim, supra.
108 This example is from Kellie T. Wardman, Balancing Loop Basics, SYSTEMS THINKER (Mar. 1994), https://thesystemsthinker.com/balancing-loop-basics/ [https://perma.cc/3W4G-DAHL].
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The arrows denote causal influence between variables, which characterizes the dynamics of the system. The "+" sign indicates that the variables move in the same direction. For example, when the gap between the desired temperature and the temperature measured by the thermostat increases, cool air production increases. The "-" sign indicates that the variables move in opposite directions. For example, as cool air production increases, the room temperature decreases. The "B" in the center of the loop stands for balancing loop to indicate that the feedback within this system maintains a stable temperature.109
In some systems feedback does not produce balance but instead reinforces a certain outcome, creating a "snowballing effect."110 For example, consider the use of air-conditioning in the larger context of global warming. In this system, hot weather prompts the use of air-conditioning, which, in turn, produces carbon emissions, which, in turn, [*409] leads to longer and more intense periods of hotter weather, which, in turn, leads to additional use of air-conditioning. The diagram in Figure 7 illustrates this simple reinforcing loop.
Figure 7. Feedback Loop Diagram of the Interaction of Air-Conditioning and Global Warming
In this second example, the arrows indicate that feedback reinforces unidirectional increase in the variables.
The rachet-like quality of food safety regulation can be modeled as a system of reinforcing feedback loops between tort litigation, government oversight, and industry supply chain management that has produced the progressively more stringent pre- and post-harvest standards that govern the leafy greens industry. As the analysis in Part II explained, government oversight in the form of outbreak investigations link specific sellers within the supply chain to individual cases, which provides causal evidence that prompts tort litigation.111 In turn, tort litigation generates
109 Id.; Kim, supra note 107, at 7-8.
110 See Kellie T. Wardman, Anatomy of a Reinforcing Loop, SYSTEMS THINKER (Feb. 1994), https://thesystemsthinker.com/anatomy-of-a-reinforcing-loop/ [https://perma.cc/5ZAV-UNRQ].
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media coverage and mobilizes survivors and their families to lobby for more government oversight.112 Additional investments in government oversight have improved public health surveillance and outbreak investigation, which has generated additional litigation.113 Figure 8 illustrates this reinforcing feedback loop.
[*410] Figure 8. Feedback Loop Diagram of Government Oversight and Tort Litigation
In a second reinforcing feedback loop, tort litigation creates liability exposure and reputational harm for leafy greens sellers, which has prompted them to increase the stringency of supply chain management standards for food safety such as the LGMA's metrics and GFSI's benchmarks.114 The implementation of these standards, in turn, provides plaintiffs with standards of care that they have used to sue negligent auditors.115 Figure 9 illustrates this second reinforcing feedback loop.
[*411] Figure 9. Feedback Loop Diagram of Tort Litigation and Industry Supply Chain Management
111 See supra notes 44-46 and accompanying text.
112 See supra notes 51-57 and accompanying text.
113 LYTTON, OUTBREAK, supra note 9, at 203-06.
114 LYTTON, OUTBREAK, supra note 9, at 197; Donica, supra note 79; Lytton, Technical Standards, supra note 64.
115 Timothy D. Lytton, Exposing Private Third-Party Food Safety Auditors to Civil Liability for Negligence: Harnessing Private Law Norms to Regulate Private Governance, 27 EUR. REV. PRIV. L. 1, 3-4 (2019).
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In a third reinforcing feedback loop, government oversight links outbreaks to specific industries or firms, which generates pressure on the identified industry to implement more stringent supply chain management to improve food safety and protect consumers.116 In turn, the industry technical committees that develop food safety standards for supply chain management advance regulatory science, informing new government regulations like the PSR, which is largely derived from the LGMA standards.117 Figure 10 illustrates this third reinforcing feedback loop. 27 Lytton: A Systems Theory of Tort Law: Reevaluating the Case Against "Regu Published by University of Missouri School of Law Scholarship Repository,
[*412] Figure 10. Feedback Loop Diagram of Industry Supply Chain Management and Government Oversight
These three interrelated reinforcing feedback loops constitute a complex system that governs leafy greens production through regulations like the PSR and industry standards like the LGMA and the GFSI. Figure 11 maps the complete system, revealing a fourth reinforcing feedback loop between tort litigation, government oversight, and supply chain management.
[*413] Figure 11. Feedback Loop Diagram of the U.S. Food Safety System
116 See supra note 92 and accompanying text; LYTTON, OUTBREAK, supra note 9, at 197.
117 See supra note 80 and accompanying text; Lytton, Technical Standards, supra note 64, at 53.
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Critics of tort law are right to compare the institutional effectiveness, efficiency, and legitimacy of litigation, government regulation, and private ordering as alternative means of designing and implementing regulatory policy. However, any complete evaluation must also consider system dynamics that, in some cases, may be the source of the most influential impacts of tort litigation on regulatory governance. B. Reconsidering Criticisms of Regulation by Litigation
Comparative institutional analysis models tort litigation, government regulation, and private markets as alternative modes of social ordering.118 However, as the systems analysis presented above demonstrates, they are interdependent, and one cannot understand the full impact of any one of [*414] them without considering its influence on the others.119 The interdependencies within a system often produce what systems theory calls leverage points. These are "places in the system where a small change could lead to a large shift in behavior."120 Viewing tort litigation as a leverage point within a system of regulatory governance reveals its essential contribution to many of the regulatory capacities that comparative institutional analysis suggests that it lacks. 1. Expertise
Critics of tort law rely on comparative institutional analysis to assert that litigation cannot match the expertise of administrative regulation. They argue that government agencies possess greater scientific and technical expertise than lawyers, judges, and juries.121 According to legal economist W. Kip Viscusi, "[r]egulation is generally superior in addressing technical scientific issues because of the importance of expertise in analyzing these regulatory issues."122 However, by sharply dividing the institutional landscape into alternatives of tort litigation and government regulation, this analysis misses the contribution that tort litigation makes to the development of policy expertise.
To begin with, as a matter of comparative institutional analysis, industry associations typically possess far more technical expertise than regulatory agencies.123 This is certainly true in the case of regulating food safety in the leafy greens industry. As described above in Part II, the FDA's produce safety rules are largely derivative of the standards developed by industry technical committees.124 Moreover, tort litigation played an essential role in generating the liability exposure, media attention, policy advocacy, consumer dissatisfaction, and government pressure that motivated industry leaders to convene those technical committees to develop the expertise that undergirds both government regulation and industry supply chain management. Whatever regulatory expertise that exists in the system is largely due to the influence through [*415] a system of feedback largely invisible to comparative institutional analysis of tort litigation. 2. Comprehensiveness
118 See, e.g., NEIL K. KOMESAR, IMPERFECT ALTERNATIVES: CHOOSING INSTITUTIONS IN LAW, ECONOMICS, AND PUBLIC POLICY 153-96 (1994) (comparing the political process, markets, and courts as alternative sources of governance norms); MORRISS ET AL., supra note 1, at 36-54 (comparing administrative rulemaking to litigation as alternative modes of regulation); Kessler, supra note 1, at 3 (describing administrative regulation and litigation as substitutes).
119 For a similar observation in environmental governance, see Kysar, supra note 7, at 63; Kysar & Reynolds, supra note 8, at 59.
120 MEADOWS, supra note 107, at 168; see Christopher Koliba et al., Complexity Theory and Systems Analysis, in HANDBOOK ON THEORIES OF GOVERNANCE 389-406 (Christopher Ansell & Jacob Torfing, eds., 2016).
121 Schuck, supra note 4, at 231-35 (arguing that courts have less access to technocratic information than administrative agencies).
122 Viscusi, supra note 1, at 2.
123 Thomas Lawton et al., Why Trade Associations Matter: Exploring Function, Meaning, and Influence, 17 J. MGMT. INQUIRY 5 (discussing trade associations as a source of knowledge and expertise about an industry).
124 See supra note 80 and accompanying text; Lytton, Technical Standards, supra note 64, at 53.
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Critics also assert that tort law suffers from myopia. According to legal scholars Andrew Morriss, Bruce Yandle, and Andrew Dorchack, "regulation imposed through litigation is always less comprehensive than regulation imposed by rulemaking because it does not apply to nonparties."125 Consequently, litigation outcomes cannot provide more than a "piecemeal" approach to policymaking.126 Viscusi also notes that when it comes to regulating products, "[g]overnment regulations will usually provide a more sound approach to promoting health than litigation does, which by its nature focuses on individual circumstances rather than the functioning of an entire product market."127 It is undoubtedly true that the focus on individual cases and limited classes of participants limits the scope of judgments and settlements in tort litigation. However, this observation may obscure more than it illuminates regarding the regulatory impact of tort litigation.
For starters, the perspective and reach of administrative regulation are often similarly limited by a focus on addressing particular cases.128 The dramatic events that prompt policymaking are typically outlier cases of a more general problem, and their salience in the minds of agency officials will tend to bias their analysis.129 Moreover, comprehensiveness is important not only in policy design but in implementation as well, and, on that score, administrative regulation often compares quite poorly in comparison to tort litigation and industry supply chain management.
The case of leafy greens illustrates this point in dramatic fashion. Since 1938, the FDA has had responsibility for regulating the food safety of fresh produce under the FDCA.130 However, the agency has never had the resources to conduct routine inspections of farms that grow fresh produce.131 Moreover, FDA inspection of processing facilities is hardly a model of comprehensive implementation. According to a recent oversight report, processing facilities typically go five to seven years between [*416] inspections, and the agency rarely follows up when it finds problems to ensure compliance with federal food safety regulations.132
By contrast, the LGMA requires leafy greens farmers in California and Arizona responsible for ninety-five percent of the leafy greens sold in the United States to undergo four rigorous audits conducted by state inspectors each year.133 Inspectors follow up to ensure that problems are remedied, and evidence suggests consistently high rates of compliance among farmers.134 In addition, farms undergo multiple private food safety audits required by commercial buyers.135 Tort litigation played an essential role in prompting both the LGMA and private auditing programs. Litigation following a large outbreak involving baby spinach in 2006 generated and sustained media coverage far beyond the typical fleeting news cycle.136 This, in turn, stoked consumer dissatisfaction and mobilized
125 MORRISS ET AL., supra note 1, at 51.
126 Id. at 49.
127 Viscusi, supra note 1, at 2-3.
128 Frederick Schauer & Richard Zeckhauser, The Trouble with Cases, in REGULATION VERSUS LITIGATION, supra note 1, at 45-70.
129 Id.
130 See supra note 82.
131 See supra note 82.
132 DEP'T OF HEALTH AND HUMAN SERVS. OFF. OF THE INSPECTOR GEN., OEI-02-14-00420, CHALLENGES REMAIN IN FDA'S INSPECTION OF DOMESTIC FOOD FACILITIES (2017).
133 See supra notes 65-70 and accompanying text.
134 See supra note 71 and accompanying text.
135 CAL. LGMA, 2020/2021 ANNUAL REPORT, supra note 69, at 10.
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consumer advocacy, creating reputational and governmental pressure on industry leaders to design and implement a rigorous auditing system that became the LGMA.137 Liability exposure and the reputational damage it threatened which was greatly magnified via feedback with media coverage, government warnings, and consumer advocacy provided similar pressure on supermarkets, restaurants, and food service companies to rely more heavily on private food safety audits of farmers and processors.138
Tort litigation has also begun to influence food safety practices on farms and processing facilities through liability and recall insurance. Although lawsuits are rare because foodborne illness is only infrequently traced back to a specific grower or processor,139 insurers nevertheless include liability coverage as a standard part of farm insurance which, according to industry experts, all farmers purchase and they also offer recall insurance to processors.140 Insurers incentivize compliance with regulatory and industry food safety standards by incorporating them into their underwriting guidelines, coverage terms, and loss control services.141
[*417] 3. Efficiency
Critics allege that, compared to the alternatives, litigation is often unnecessarily complex, protracted, and costly.142 On this account, administrative regulation is a much more efficient means of deterring undesirable risk and compensating accident victims.143 However, when it comes to policymaking and implementation, the legislative process and administrative rulemaking are hardly models of simplicity, brevity, and efficiency.
Both legislation and rulemaking involve myriad stakeholders, labyrinthine networks of influence, can take decades from initiation to implementation, and involve incalculable expenditures on lobbying, policy research, public input, and bureaucratic resources. Consumer groups lobbied for decades for binding federal food safety regulations governing fresh produce cultivation before the passage of FSMA in 2010, and it took additional years of litigation and delay to produce the PSR, which has still not been fully implemented.144 Moreover, the interdependence of tort litigation, government regulation, and supply chain management makes it hard to attribute the various costs and benefits of policymaking and implementation to each of them in assessing their contributions to advancing regulatory governance. An appreciation for the systems dynamics of regulatory governance greatly complicates claims about the relative efficiency of litigation compared to legislation and administrative rulemaking. 4. Legitimacy
Critics argue that regulation by litigation lacks the political legitimacy enjoyed by administrative regulation. According to Viscusi, "[t]he policies that result from litigation almost invariably involve less public input and accountability than government regulation."145 According to Morriss et al., "[t]o the extent that public participation confers legitimacy on regulation, regulations imposed by litigation lack legitimacy compared with those imposed
136 See supra notes 51-53.
137 LYTTON, OUTBREAK, supra note 9, at 133-37, 197-98.
138 Id. at 254-56.
139 See supra notes 94-95 and accompanying text.
140 Lytton, Using Insurance, supra note 61, at 308, 313-17.
141 Id. at 328-33.
142 ROBERT A. KAGAN, ADVERSARIAL LEGALISM: THE AMERICAN WAY OF LAW 4, 161-63 (2d ed. 2019).
143 Id.; STEPHEN D. SUGARMAN, DOING AWAY WITH PERSONAL INJURY LAW (1989).
144 LYTTON, OUTBREAK, supra note 9, at 121-47; Lytton, Known Unknowns, supra note 86, at 891.
145 Viscusi, supra note 1, at 1.
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through rulemaking or negotiation."146 However, agency rulemaking is not always as transparent as these arguments imply.
[*418] In developing the PSR, the FDA cloaked unjustified standards in the garb of scientific rhetoric and unsound cost-benefit analysis in what could fairly be characterized as a charade.147 More generally, administrative law scholar Wendy Wagner has documented how agency rulemaking is dominated by industry information that overwhelms the input of other stakeholders and exerts undue influence on agencies.148
Moreover, broad stakeholder participation is by no means the exclusive province of notice-and-comment rulemaking, nor are other decision-makers in the system unaccountable. In the case of leafy greens, industry technical committees include participants from industry, government, academia, and consumer groups.149 A desire to bolster the legitimacy of industry standards in the eyes of producers and consumers led the LGMA to develop rulemaking procedures modeled on the APA's notice-and-comment requirements.150 The LGMA established a process for developing new and revised standards that provides public notice at every stage of the process, encourages broad stakeholder input, responds to comments, provides written justification for decisions, subjects final proposals to open public hearings with a written record before a representative technical committee, and includes two post-hearing reviews by the LGMA Board and the California Secretary of Agriculture before a change is approved. This process has the hallmarks of transparency, participation, and accountability associated with legitimacy. Moreover, the LGMA and its industry members are highly accountable to consumers, who have typically sent strong market signals of dissatisfaction following outbreaks, repeatedly leading the LGMA to tighten its standards.151 A systems analysis reveals how tort litigation has prompted industry reforms characterized by a relatively high level of participation, transparency, and accountability. 5. Redundancy
Critics contend that tort litigation is redundant, offering nothing more than an unnecessary alternative to administrative regulation. According to one account, "any regulation imposed through litigation is at best an imperfect substitute for a regulation imposed through rulemaking or [*419] negotiation. This alone guarantees that regulation-by-litigation is less effective than regulation by other means."152 However, when one takes regulatory dynamics into account, the redundancy of tort litigation is a virtue rather than a vice of the system.
Systems theory reveals how tort litigation functions as what political scientists Frank Baumgartner and Bryan Jones call a policy venue an institutional setting where policymaking takes place.153 Baumgartner and Jones analyze why policymaking tends to alternate between periods of "equilibrium," characterized by public apathy and institutional stasis, and periods of "instability," characterized by heightened concern and policy innovation.154 A venue change can destabilize a policy equilibrium and prompt policy innovation.155
146 MORRISS ET AL., supra note 1, at 52; see id. at 49, 54.
147 For an extensive analysis, see Lytton, Known Unknowns, supra note 86, at 911-15.
148 Wendy Wagner, Administrative Law, Filter Failure, and Information Capture, 59 DUKE L.J. 1321 (2010).
149 See, e.g., CPS Technical Committee, CTR. FOR PRODUCE SAFETY, https://www.centerforproducesafety.org/cps-technical- committee [https://perma.cc/KLR3-U5WN] (last visited Jan. 29, 2024); see also Lytton, Technical Standards, supra note 64, at 56.
150 Lytton, Technical Standards, supra note 64, at 56-58.
151 Id.
152 MORRISS ET AL., supra note 1, at 51.
153 FRANK R. BAUMGARTNER & BRYAN D. JONES, AGENDAS AND INSTABILITY IN AMERICAN POLITICS 31-32 (1993).
154 Id. at 1-4, 18-21.
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In the case of leafy greens, when an outbreak occurs, tort litigation becomes an alternative venue for food safety policy. Tort law frames the problem in terms of failures by growers and processors, and that characterization is amplified and proliferated in other venues the media, public discourse, congressional hearings, agency departments, and industry technical committees in the numerous ways described above.156 It might be the case that any standard produced by a judgment or settlement in litigation would be inferior to a rule produced through notice-and-comment rulemaking or industry standard setting. However, the point is that without tort litigation, those other venues settle into a policy equilibrium which only tort litigation can destabilize.157
6. Feedback and Learning
Finally, critics insist that litigation is an inferior alternative to administrative regulation when it comes to feedback and learning the capacity to evaluate policy outcomes and make improvements. According to law professor Peter Schuck: [*420]
Courts lack any reliable way to obtain feedback on their policies' real-world effects, and . . . they are poorly equipped institutionally to assess the policy implications of . . . new evidence. Judges depend for their information largely on the particular litigants and disputes that happen to come to their courtroom . . . . A risk regulator, in contrast, has numerous opportunities to revisit its earlier decisions and revise them whenever it seems appropriate. Indeed, regulators have institutionalized formal techniques for doing so oversight hearings, notice-and-comment rule making, reauthorizations, and the like and access to the information and expertise needed to assess the case for change and the various reform options that are available.158
Schuck, however, also points out that administrative agencies typically lack both the resources and the motivation to evaluate the effectiveness of the regulatory programs they administer.159
A systems theory analysis demonstrates that tort litigation has been essential to the process of feedback and learning over the past twenty-five years of policy development in the regulation of leafy greens. The congressional oversight hearings that have motivated FDA policy evaluation and notice-and-comment rulemaking to revise existing policies were prompted by widespread consumer anxiety and concerted lobbying efforts by consumer advocates both of which were fueled by the feedback between tort litigation and media coverage in the aftermath of outbreaks.160 Moreover, the primary locus of feedback and learning has been technical committees and stakeholder groups that include industry experts, academic researchers, government officials, and consumer advocates.161 These gatherings, which focus on feedback and learning, have been convened by government agencies, industry trade associations, and independent policy nonprofits.162 All of them have been prompted by the
155 Id. at 20, 32-33. For a related analysis, see Kysar, supra note 7, at 51 (describing how the adjudication of tort claims serves as a catalyst for "the larger hydraulics of governance").
156 See supra notes 11-12 and accompanying text.
157 See Thomas O. McGarity, Some Thoughts on "Deossifying" the Rulemaking Process, 41 DUKE L. J. 1385 (1992); Jerry L. Mashaw, A Comment on Causation, Law Reform, and Guerilla Warfare, 73 GEO. L.J. 1393 (1985) (describing the mobilizing effect of tort litigation as akin to guerilla warfare); see also PAUL NOLETTE, FEDERALISM ON TRIAL: STATE ATTORNEYS GENERAL AND NATIONAL POLICYMAKING IN CONTEMPORARY AMERICA 206-07 (2015) (surveying justifications for redundancy in regulatory regimes).
158 Schuck, supra note 4, at 241-42.
159 PETER H. SCHUCK, WHY GOVERNMENT FAILS SO OFTEN: AND HOW IT CAN DO BETTER 391 (2014); John Bridgeland & Peter Orzag, Can Government Play Moneyball?, THE ATLANTIC, July-Aug. 2013 (estimating that "less than $1 out of every $100 of government spending is backed by even the most basic evidence that the money is being spent wisely").
160 See supra notes 82-87, 145 and accompanying text.
161 See Lytton, Known Unknowns, supra note 86, at 894-98.
162 Id. at 896-97.
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same pressures that gave rise to congressional oversight hearings pressures created in large measure by tort litigation. Tort litigation has served as a primary lever in the iterative process of policy evolution.
[*421] C. Thinking in Terms of Risk Regimes
Critics might object that the foregoing analysis sets up a straw man. They readily acknowledge that tort litigation can play a useful role in "focusing the political process on a problem without subverting the democratic accountability that the political process, however imperfectly, provides."163 On this account, litigation does not become regulation when it merely "spur[s] the political process to address [an] issue and to create a solution that displace[s] litigation."164 What the critics object to is not the role that tort litigation plays in prompting administrative regulation but instances in which litigation displaces administrative regulation and substitutes judicial decisions and settlement agreements for notice-and-comment rulemaking. Comparative institutional analysis, they argue, reveals that judicial decisions and settlement agreements are inferior alternatives to administrative rulemaking.
In response, this Article argues that by focusing on instances where tort law purportedly displaces other modes of regulation, the critics are guilty of oversimplifying the analysis in ways that obscure more than they reveal. The problem with comparative institutional analysis, as practiced by the critics of tort law, lies in framing litigation as an alternative to administrative regulation. By contrast, systems analysis suggests that the proper unit of evaluation is the regulatory system, and a fair assessment of tort litigation must consider its role within that system. This response to the critics of tort law is part of a larger trend among scholars to adopt a more expansive and inclusive conception of regulatory governance.
A growing appreciation for the role of private standards in many areas of regulation has led scholars to question the descriptive accuracy of the traditional distinction within regulatory theory between private ordering and public regulation and to replace this distinction with the more holistic concept of risk regimes.165 Regulatory policy discussions often entail disagreement between advocates of less government intervention in industrial affairs and proponents of greater government involvement in, for example, protecting the environment, managing the economy, and advancing public health. However, the dichotomy underlying these terms of debate the implicit choice between unregulated markets and [*422] government mandates obscures the interaction and interdependence of private industry and public authority in developing regulatory standards, monitoring compliance, and disciplining those who fail to conform.166 As legal scholar Harm Schepel explains, "social steering is becoming more and more a property of the interaction of organizations, networks, and associations involving both public and private actors, rather than a product of government control of and intervention in society."167 Thus, concludes legal scholar Jody Freeman, "[c]ontemporary governance might be best described as a regime of 'mixed administration' in which private actors
163 MORRISS ET AL., supra note 1, at 103; see also Viscusi, supra note 1, at 3.
164 MORRISS ET AL., supra note 1, at 103.
165 This paragraph is excerpted from Lytton, Technical Standards, supra note 64, at 45-46. For foundational work on the concept of risk regimes, see CHRISTOPHER HOOD ET AL., THE GOVERNMENT OF RISK: UNDERSTANDING RISK REGULATION REGIMES (2001) and Jody Freeman, Private Parties, Public Functions and the New Administrative Law, 52 ADMIN. L. REV. 857 (2000). See also David Levi-Faur, Regulation and Regulatory Governance, in HANDBOOK ON THE POLITICS OF REGULATION 3, 13-14 (David Levi-Faur ed., 2011); Colin Scott, Regulating Everything: From Mega- to Meta-Regulation, 60 ADMINISTRATION 61, 67 (2012).
166 This dichotomy also obscures the role of government regulation in making markets possible. See Harm Schepel, Rules of Recognition: A Legal Constructivist Approach to Transnational Private Regulation, in REGULATORY HYBRIDIZATION IN THE TRANSNATIONAL SPHERE 192-95 (Paulius Jurcys et al. eds., 2013); see also LIORA SALTER, MANDATED SCIENCE: SCIENCE AND SCIENTISTS IN THE MAKING OF STANDARDS 179 (1988).
167 HARM SCHEPEL, THE CONSTITUTION OF PRIVATE GOVERNANCE: PRODUCT STANDARDS IN THE REGULATION OF INTEGRATING MARKETS 19-20 (2005); see SALTER, supra note 166, at 64.
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and government share regulatory roles."168 The concept of a risk regime denotes the infrastructure of private and public entities engaged in regulatory governance.169
The analysis of food safety regulation in the leafy greens industry presented in this Article adds litigation to the picture. It rejects the clean distinction between litigation, regulation, and private ordering within regulatory governance systems, and it exposes the limits of comparative analysis that models them as alternatives. To be sure, the desirability of tort litigation as a means of advancing regulatory policy will vary in different contexts, and fair-minded evaluations must take seriously the particularities of each case. There are undoubtedly instances in which judges and litigants may do more harm than good. This Article argues merely that assessments of tort law should take seriously the interactions of tort litigation with other institutions and the effect of those interactions on the performance of the risk regime as a whole.
[*423] IV. CONCLUSION
Critics of using tort law to advance regulatory goals argue that litigation outcomes are less informed, less efficient, less comprehensive, and less inclusive than notice-and-comment rulemaking.170 These claims rest on comparative institutional analysis, which views litigation and regulation as alternatives and evaluates the tradeoffs in relying more heavily on one than the other.171 By contrast, the systems theory of tort law developed in this Article shifts the focus of analysis from litigation outcomes to the litigation process and emphasizes the interdependence of multiple institutions not only courts, legislatures, and agencies, but also media organizations, advocacy groups, insurance underwriters, and industry trade associations in the creation and implementation of regulatory policy. In doing so, the Article reframes the long running-debate over tort law's regulatory value.
This Article is just a start. Although the case study of food safety presented here provides insights from which to derive a systems theory of tort law, more work needs to be done to refine the theory. Luckily, the field of scholarship beyond leafy greens is already heavily seeded with many careful case studies analyzing the impact of lawsuits on public policy. Prominent examples include litigation over asbestos,172 tobacco control,173 medical errors,174 opioid addiction,175 institutional coverup of child sexual abuse,176 police misconduct,177 and climate change.178 These
168 Freeman, supra note 165, at 816.
169 The role of private standards in governance is not unique to health and safety regulation, nor is awareness of it new. Social theorists dating back to the nineteenth century have appreciated that economic and social regulation have never really been the exclusive domain of government authorities and that private entities perform regulatory functions. See SCHEPEL, supra note 167, at 12-19. For a landmark study of the role of private standards in health and safety regulation, see Robert W. Hamilton, The Role of Nongovernmental Standards in the Development of Mandatory Federal Standards Affecting Safety or Health, 56 TEXAS L. REV. 1329 (1978).
170 See supra notes 1, 122-23, 126-28, 143-44, 146-47, 153, 159 and accompanying text.
171 See, e.g., Kessler, supra note 1, at 1-3.
172 See, e.g., PAUL BRODEUR, OUTRAGEOUS MISCONDUCT, THE ASBESTOS INDUSTRY ON TRIAL (1985).
173 See, e.g., Jacobson & Warner, supra note 7.
174 See, e.g., TOM BAKER, THE MEDICAL MALPRACTICE MYTH (2005).
175 See, e.g., Engstrom & Rabin, supra note 8.
176 See, e.g., LYTTON, BISHOPS, supra note 7.
177 See, e.g., EPP, supra note 8.
178 See, e.g., Kysar & Reynolds, supra note 8.
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and other studies by critics and defenders alike provide fertile ground to cultivate a general systems theory of tort law.
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