291 Bystanders to a Public Health Crisis: The Failures of the U.S. Multi-Agency Regulatory Approach to Food Safety in the Face of Persistent Organic Pollutants Katya S. Cronin1 Per- and polyfluoroalkyl substances (PFAS) are devastating our food systems and our health. Due to widespread use, these synthetic, long- lasting chemicals, are omnipresent at dangerous levels in our envi- ronment and our homes. Recent studies link even small exposure to PFAS to a host of adverse health outcomes, including cancer, autoim- mune diseases, thyroid disease, liver damage, childhood obesity, infer- tility, and birth defects. Food consumption is a primary route of PFAS exposure. PFAS mi- grate from water, soil, fertilizers, pesticides, and compost into virtually every plant, fish, animal, and animal product, and ultimately (in the greatest concentration) into the consumer. In addition, food pro- cessing equipment, disposable dishes, and containers leach dangerous levels of these chemicals into processed food products, further infusing our every meal with PFAS. Consequently, it is no surprise everything from chocolate cake and microwave popcorn to free range eggs, wild 1. Associate Professor of Fundamentals of Lawyering, The George Washington University Law School & Affiliate Associate Professor, The Global Food Institute. I would like to thank Peter Hutt, Emily Broad Leib, Susan Schneider, Sarah Everhart, Sarah Berger Richardson, Marie Boyd, Adam Muchmore, Delcianna Winders, Laura Fox, Daniel Aaron, and Tayyaba Zeb for providing comments on earlier drafts, and the faculty of the George Washington University Law School, the Academy of Food Law & Policy, and the AALS Sections on Environmental Law, Natural Resources & Energy Law, Agriculture & Food Law, and Animal Law for the opportunity to present this paper and to receive helpful feedback. Thanks also to Kendall Hagman, Julia Kiley, and Samantha Flanzer for excellent research assistance. 292 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 caught fish, organic milk, and organic kale can harbor staggering quantities of these toxic substances. Despite the widespread presence of these substances and strong sci- entific evidence of their harmful impact on humans, federal regulation of PFAS in food is currently nonexistent. At least fifteen agencies have a mandate to ensure the safety of our food. More is not always better. In the case of regulatory agencies, it can lead to fragmented demand for attention, diffusion of responsibilities, and bureaucratic bystander apathy. This story has played out time and again with other toxic con- taminants like polychlorinated biphenyls (PCBs) and pesticides and is playing out yet again with PFAS. Despite our country’s devastating experience with past contaminants and the unprecedented scientific progress of our time, the federal response to new food safety threats has only become more sluggish and inadequate. This article lays a pathway for change, taking the issue of PFAS food contamination as a case study for the broader dysfunction in the food safety regulatory system. Part II reviews the history of federal food regulation and explores the role that each federal actor in the field plays in ensuring the safety of the food supply. Part III provides back- ground on the chemical and toxicological profile of PFAS and their widespread presence in the environment in general and the food sup- ply in particular. Part IV examines possible approaches to more effec- tive regulation of environmental contaminants in food and proposes a readily available but currently overlooked mechanism for combatting the current public health crisis of PFAS in food. Lastly, Part V cata- logues the expected benefits of the solution and addresses anticipated skepticism. It concludes that the proposed approach can effectively protect consumers from PFAS in food today, while simultaneously gar- nering much needed data to usher in a more permanent solution in the future. I. Introduction .................................................................................................. 293 II. Regulatory System in Disarray .............................................................. 296 A. History of Fragmented Regulation ................................................... 296 B. The Present State of Chaos .................................................................. 300 1. The Food and Drug Administration ............................................. 300 2. Food Safety and Inspection Service ............................................. 303 3. The Environmental Protection Agency ...................................... 306 4. Other Agency Actors .......................................................................... 308 C. More Is Not Always Better ................................................................... 310 III. Regulating PFAS: A Case Study in Dysfunction and Diffused Responsibility. .............................................................................................. 314 2024] Bystanders to a Public Health Crisis 293 A. Background on PFAS .............................................................................. 315 B. PFAS in Our Food Supply ...................................................................... 316 C. Current Regulation of PFAS ................................................................. 318 D. PFAS-Specific Regulatory Challenges .............................................. 322 IV. In Search of a Solution to the Crisis of PFAS in Food .................... 325 A. A Centralized Food Safety System .................................................... 326 B. Banning PFAS in Food Products ........................................................ 328 C. Relying on FDA and USDA Authority ............................................... 329 D. Breaking Free from Bystander Apathy: Empowering EPA to Act333 1. EPA Could Ban the Use of PFAS in Pesticides .......................... 337 2. EPA Could Set PFAS Tolerances for Food Products .............. 339 V. Advantages and Challenges ..................................................................... 344 A. Anticipated Benefits ............................................................................... 345 B. Major Questions Doctrine .................................................................... 346 C. Temporary Nature of the Solution ................................................... 352 D. Limited Testing Capabilities ................................................................ 353 VI. Conclusion ...................................................................................................... 355 I. INTRODUCTION “In food, excellent medicine can be found; in food, bad medicine can be found.” Hippocrates2 Seemingly every other day, a concerning news title warns us of the dangers of toxic “forever chemicals,” known as PFAS. “PFAS ‘forever chemicals’ linked to higher thyroid cancer risk, study finds.”3 “PFAS exposure linked to decreased bone health in adolescents and young adults.”4 “Exposure to ‘forever chemicals’ during pregnancy linked 2. Diana Cardenas, Let Not Thy Food Be Confused With Thy Medicine: The Hippocratic Mis- quotation, EUR. SOC’Y FOR CLINICAL NUTRITION & METABOLISM, Dec. 2013, at 2 (2013) (quot- ing/translating THE HIPPOCRATIC CORPUS). 3. Bob Curley, PFAS 'Forever Chemicals' Linked to Higher Thyroid Cancer Risk, Study Finds, MED. NEWS TODAY (Oct. 25, 2023), https://www.medicalnewstoday.com/articles/pfas-forever- chemicals-linked-to-higher-thyroid-cancer-risk [https://perma.cc/9BLP-ULUL]. 4. Zara Abrams, PFAS Exposure Linked to Decreased Bone Health in Adolescents and Young Adults, KECK SCH. OF MED. OF UNIV. OF S. CA. NEWSROOM (Dec. 5, 2023), https://keck.usc.edu/news/pfas-exposure-linked-to-decreased-bone-health-in-adolescents- and-young-adults/ [https://perma.cc/QSY3-TXNU]. 294 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 to increased risk of obesity in kids.”5 “Common PFAS Chemicals Linked to Cancers in Women.”6 On and on goes the daily parade of horribles. And just about every other month, a new report tells us PFAS are also in our daily food and drink. “PFAS Found in Eggs Laid by Hens that are Fed Contaminated Feed.”7 “U.S. Kale Contains ‘Disturbing’ Amounts of ‘Forever Chemicals,’ Research Finds.”8 “New Study Finds PFAS in Bottled Water.”9 “PFAS chemical found in chocolate cake.”10 Amid this grim news cycle, one would be justified to ask: How is this possible? Where are the regulators in charge of food safety and what are they doing about this? Could anything even be done to stop this public health catastrophe? This article aims to answer these questions by offering (1) a com- prehensive overview of the federal food safety regulatory system, (2) a helpful analytical framework for examining possible approaches to emerging food safety threats, and (3) a readily available, workable, and, so far, overlooked regulatory mechanism that can help stem the tide of widespread PFAS contamination in food. The article proceeds in four parts. Part II explores the current federal food safety system by first looking at its history and its sources of fragmentation and friction. It then analyzes the present state of the system and its many actors, zeroing in on the jurisdictional limits, institutional advantages, and structural handicaps of each of the major players. Finally, this sec- tion posits that although the fragmented nature of the food regulato- ry system results in many ills, the most relevant failing with respect 5. Corrie Pikuk, Exposure to ‘Forever Chemicals’ During Pregnancy Linked to Increased Risk of Obesity in Kids, BROWN UNIV. (June 7, 2023), https://www.brown.edu/news/2023-06- 07/pfas-obesity [https://perma.cc/M445-V52B]. 6. Denise Mann, Common PFAS Chemicals Linked to Cancers in Women, U.S. NEWS (Sept. 19, 2023), https://www.usnews.com/news/health-news/articles/2023-09-19/common-pfas- chemicals-linked-to-cancers-in-women [https://perma.cc/AQF4-RYCZ]. 7. PFAS Found in Eggs Laid by Hens that are Fed Contaminated Feed, FOOD SAFETY MAG. (Feb. 2, 2023), https://www.food-safety.com/articles/8318-pfas-found-in-eggs-laid-by-hens-that- are-fed-contaminated-feed [on file with the Journal]. 8. Eva Hagan, U.S. Kale Contains “Disturbing” Amounts of “Forever Chemicals,” Research Finds, GREEN MATTERS (July 21, 2023), https://www.greenmatters.com/health-and-wellness /pfas-kale [https://perma.cc/D2GV-JE76]. 9. Ryan Felton, New Study Finds PFAS in Bottled Water, as Lawmakers Call for Federal Limits, CONSUMER REPS. (June 17, 2021), https://www.consumerreports.org/health/bottled-water /pfas-in-bottled-water-new-study-finds-a1111233122/ [https://perma.cc/UPW3-H98T]. 10. Britt E. Erickson, PFAS Chemical Found in Chocolate Cake, 97 CHEM. & ENG’G NEWS, June 10, 2019, at 17 (2019). 2024] Bystanders to a Public Health Crisis 295 to emerging food safety threats is the issue of regulatory bystander apathy. Part III introduces the problem of PFAS contamination in food as a case study of bystander apathy. It provides background on the chemical and biological profile of these substances, traces their roots to food products, and surveys the current dearth of regulatory ef- forts to combat their widespread and devastating consequences. The section also analyzes the peculiar hurdles that this group of chemicals presents, which any proposed regulatory fix would have to overcome. Part IV searches for a feasible solution. It first grapples with the most commonly proposed solution to the overall dysfunction plagu- ing the food safety system—a massive regulatory overhaul resulting in a unified, single-agency scheme. It concludes that such a step is practically infeasible and cannot effectively address a pressing public health concern like PFAS contamination of food in a timely manner. Next, the article explores the possibility of PFAS-specific legislation or regulation driven by the Food and Drug Administration (FDA). While increased public attention on PFAS may eventually lead to such actions, the current political climate, intense lobbying efforts, and the food agencies’ sluggish response are likely to delay such a fix. The article thus proposes a solution that bridges the gap be- tween the present crisis and long-term action on PFAS. The pro- posed approach relies on the Environmental Protection Agency’s (EPA’s) current regulatory authority over pesticides. It urges EPA— the only federal agency that has so far shown willingness to deal with PFAS contamination—to ban the use of PFAS in pesticides, monitor PFAS occurrence in food systematically, and enforce low tolerances for PFAS residue on food products. Lastly, Part V examines the advantages of this proposal and ad- dresses some anticipated concerns, including a potential major ques- tions doctrine challenge, the politically precarious nature of agency- level actions, and the need to rely on limited testing and enforcement capabilities. This section argues that, while not without its challeng- es, the proposed action would help protect consumers from repeated exposure to toxic substances, while establishing ground truth about the real degree of PFAS contamination in food, enabling remediation of contaminated environments, and ushering in longer-term legisla- tive reform. 296 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 II. REGULATORY SYSTEM IN DISARRAY “Question: ‘What is more scrambled than an egg?’ Answer: ‘The federal food inspection system.’” Rep. Jon C. Porter11 It is an indisputable fact that the U.S. food regulatory system is “of- ten duplicative, sometimes contradictory, undeniably costly, and un- duly complex.”12 With a system of cumbersome and antiquated food safety laws and at least thirteen agencies having regulatory authority over food,13 this criticism is hardly surprising. This section traces the historical origins of this fragmentation, surveys the present state of jurisdictional divisions and limitations, and explores the many challenges posed by the current regulatory system. A. History of Fragmented Regulation Although societies have dealt with food safety issues for most of human history,14 in the United States, food safety regulation has a relatively short, yet sordid, record. In 1862, the thirty-seventh Con- gress established the United States Department of Agriculture (USDA), with an Act signed by President Lincoln.15 The enabling statute charged the Department to “acquire and to diffuse among the people of the United States useful information on subjects connected with agriculture in the most general and comprehensive sense of that word, and to procure, propagate, and distribute among the peo- ple new and valuable seeds and plants.”16 At the beginning, the De- partment’s mission lacked a food safety focus. Routine adulteration of food through unsanitary processing prac- tices, impurities, and additives, however, eventually led Congress to 11. Question: What is More Scrambled Than an Egg? Answer: The Federal Food Inspection System: Hearing before the Subcomm. on the Fed. Workforce and Agency Org., 109th Congress, 109–47 (2005). 12. STAFF OF S. COMM. ON GOV’T AFF., 95TH CONG., FOOD REGUL.: A CASE STUDY OF USDA AND FDA 90, 113 (Comm. Print 1977) [hereinafter CASE STUDY OF USDA AND FDA]. 13. Richard A. Merrill & Jeffrey K. Francer, Organizing Federal Food Safety Regulation, 31 SETON HALL L. REV. 61, 127 (2000). 14. See Peter Barton Hutt & Peter Barton Hutt II, A History of Government Regulation of Adulteration and Misbranding of Food, 39 FOOD DRUG COSM. L. J. 2, 5(1984) (detailing food safety codes from biblical times). 15. Act to Establish a Department of Agriculture, ch. 72, 12 Stat. 387 (1862) (codified as amended at 7 U.S.C. § 2201). 16. Id. 2024] Bystanders to a Public Health Crisis 297 pass the first federal food safety law—An Act to Prevent the Impor- tation of Adulterated and Spurious Tea—in 1883.17 Three years lat- er, another law, the Oleomargarine Act of 1886 sought to regulate the sale of domestic margarine marketed as butter.18 Due to the prevalence of chemical adulteration of foods, USDA’s Division of Chemistry—which up until that point had been largely concerned with studying soil composition—was redesignated the “Bureau of Chemistry” and was tasked with studying the effects and safety of chemical additives to food.19 This was the beginning of the ideologi- cal division of responsibilities in the federal food regulatory sys- tem—with the Bureau of Chemistry focused on consumer safety while other agencies within USDA focused on promoting and sup- porting agriculture and food producers.20 These two missions with- in the Department were often at odds with each other and caused considerable personal and political friction.21 A major victory for the food safety side of the Department came in 1906. The tireless efforts of the Bureau’s Chief Chemist, Dr. Harvey Wiley, along with the publication of Upton Sinclair’s The Jungle,22 prompted President Theodore Roosevelt to sign into law two acts of Congress on the same day: the Pure Food and Drug Law (PFDA)23 and the Meat Inspection Act (MIA)24. Curiously, Congress vested USDA (and its Bureau of Animal Industry) with sole responsibilities for the inspection and seizure of adulterated meat under the MIA, but split the implementation of the PFDA between “the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce,” with the Bureau of Chemistry advising all three in 17. An Act to Prevent the Importation of Adulterated and Spurious Tea, ch. 64, 22 Stat. 451 (1883), repealed by 29 Stat. 604 § 12 (1897). 18. See NEAL D. FORTIN, FOOD REGULATION: LAW, SCIENCE, POLICY, AND PRACTICE 4 (2d ed., 2017). 19. Milestones in U.S. Food and Drug Law History, U.S. FOOD & DRUG ADMIN. (last updated Jan. 30, 2023), https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law [https://perma.cc/YW35-CDLB]. 20. See generally DEBORAH BLUM, THE POISON SQUAD: ONE CHEMIST’S SINGLE-MINDED CRUSADE FOR FOOD SAFETY AT THE TURN OF THE TWENTIETH CENTURY (1st ed., 2018) (detailing the history of the Bureau of Chemistry and the ideological conflicts between Harvey Wiley and his superiors at USDA). 21. See id. 22. See generally UPTON SINCLAIR, THE JUNGLE (1906) (detailing the abhorrent conditions of meat processing in the United States). 23. Pure Food and Drug Act of 1906, ch. 3915, 34 Stat. 768, repealed by Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §392(a) (1938). 24. Meat Inspection Act of 1907, ch. 2907, 34 Stat. 1260, amended by Wholesome Meat Act, Pub. L. No. 90-201, 81 Stat. 584 (1967). 298 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 promulgating rules.25 This allocation of responsibility, along with many philosophical and personal disagreements inside USDA over the degree of regulation needed to ensure pure food, further exacer- bated the already-entrenched conflicts between the Bureau of Chem- istry and the Department at large.26 These clashes eventually led to a formal division of the Depart- ment of Agriculture. In 1907, the Secretary of Agriculture created a new Board of Food and Drug Inspection, which was designed to serve as a counterbalance to the Bureau of Chemistry’s approach to food purity.27 In 1927, Congress spun out the Bureau’s enforcement role into a separate agency, still housed within the Department of Agriculture—the Food, Drug, and Insecticide Administration.28 In 1930, USDA renamed it the Food and Drug Administration (FDA).29 The passage of the 1938 Food, Drugs, and Cosmetics Act (FDCA) sig- nificantly augmented the authority of FDA over food safety—which now extended to creating food quality standards, establishing toler- ance limits for unavoidable poisons, inspecting food production facil- ities, and regulating food labeling.30 In 1939, pursuant to the Reor- ganization Act,31 Congress created a new unit within the executive branch—the Federal Security Authority (the predecessor to the modern-day Department of Health and Human Services).32 And, in 1940, President Franklin Roosevelt announced that “[t]he Food and Drug Administration in the Department of Agriculture and its func- tions, except those functions relating to the administration of the In- secticide Act of 1910 and the Naval Stores Act, are transferred to the Federal Security Agency.”33 Although FDA gained authority over 25. Meat Inspection Act of 1907, ch. 2907, 34 Stat. 1260, amended by Wholesome Meat Act, Pub. L. No. 90-201, 81 Stat. 584 (1967); Pure Food and Drug Act of 1906, ch. 3915, 34 Stat. 768, repealed by Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §392(a) (1938). 26. See generally BLUM, supra note 20. 27. Merrill & Francer, supra note 13, at 80. 28. Id. 29. Id. at 81. 30. Act of June 25, 1938, ch. 675, 52 Stat. 1040 (codified at 21 U.S.C. §§ 1–15 (1938) (cur- rent version at 21 U.S.C. §§ 301-399). See also 21 U.S.C. §341 (1994) (authorizing FDA to promulgate food quality standards to promote "honesty and fair dealing"); id. §346 (directing FDA to promulgate tolerances for substances that "cannot be avoided" in food production); id. §374 (providing FDA with inspection authority of food production facilities). 31. Act of Apr. 3, 1939, ch. 36, 53 Stat. 561, amended by Reorganization Act of 1966, Pub. L. 89-554, 80 Stat. 394 (codified at 5 U.S.C. §901). 32. Exec. Order No. 8205, 4 Fed. Reg 3313 (July 14, 1939) Authorizing the Initial Appoint- ment of The Assistant Administrator for the Federal Security Agency. 33. See Reorganization Plan No. IV of 1940, 5 Fed. Reg. 2421 § 12, reprinted in 54 Stat. 1237 (1940). 2024] Bystanders to a Public Health Crisis 299 most food products, USDA fought for and retained its authority over meat products. The formal separation of USDA and FDA did not put an end to the jurisdictional infighting, however. Not only did the agencies inherit jurisdictional overlaps, but newly passed laws continued to split re- sponsibilities between the two agencies, perpetuating the problem. For example, in 1947, Congress passed the Federal Insecticide, Fun- gicide, and Rodenticide Act (FIFRA), pursuant to which USDA over- saw approving pesticides for shipping and use on food crops, while FDA was responsible for setting and enforcing permissible residue on food products.34 Although the history of USDA and FDA most prominently depicts the rifts in the federal food regulatory system, these were far from the only relevant agency actors. Tracing back to the allocation of re- sponsibilities under the PFDA, the Department of the Treasury levied taxes on imitation or adulterated products, while the FTC took over the regulation of food advertisement.35 The Department of Com- merce was also responsible for regulating seafood.36 In 1970, fol- lowing the publication of Rachel Carson’s Silent Spring37—which shined a spotlight on the irresponsible use of herbicides and insecti- cides in the U.S.—President Nixon transferred the responsibility over pesticide regulation from USDA to the newly-created Environ- mental Protection Agency.38 EPA also took on FDA’s authority to set and enforce pesticide tolerances on food.39 New and evolving threats to food safety also required increased research efforts, re- sponsibility for which was shared between the Agricultural Research Service housed in USDA, the Center for Disease Control and Preven- tion, and the National Institute of Health.40 The chaotic diffusion of regulatory responsibility over food safety only increased from there. 34. Federal Insecticide, Fungicide, and Rodenticide Act of 1947, ch. 125, 61 Stat. 163. 35. See U.S. COMM’N ON ORG. OF THE EXEC. BRANCH OF THE GOV’T, THE HOOVER COMMISSION REPORT 250–51 (McGraw-Hill eds., 1949) [hereinafter HOOVER COMMISSION REPORT]. 36. U.S. GENERAL ACCOUNTING OFFICE, Pub. No. GAO/RCED-91-19B, FOOD SAFETY AND QUALITY—WHO DOES WHAT IN THE FEDERAL GOVERNMENT 89 (1990). 37. See generally RACHEL CARSON, SILENT SPRING (Houghton-Mifflin eds.,1962). 38. See Reorganization Plan No. 3 of 1970, 35 Fed. Reg. 15,623 (1970), reprinted in 42 U.S.C. §4321 (1970) (establishing EPA). See also 21 U.S.C. §346(a) (1938). 39. 21 U.S.C. §346(a) (1938). 40. Merrill & Francer, supra note 13, at 85, 90. 300 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 B. The Present State of Chaos With the ever-increasing complexity of consumer behaviors, food processing capabilities, and new threats to safety, the food regulato- ry system has only gotten more cumbersome, compound, and crip- pled over the last century. Currently, at least fifteen different agen- cies, housed within five Departments, have some authority over food safety.41 This section focuses on the three main agencies in the field—the Food and Drug Administration, the Food Safety and In- spection Service, and the Environmental Protection Agency. It ana- lyzes their jurisdictional reach, institutional strengths, and regulato- ry challenges in responding to emerging food safety threats, like those posed by environmental contaminants. 1. The Food and Drug Administration The Food and Drug Administration, housed within the Department of Health and Human Services, is the main player in the field of food safety regulation. FDA’s mission with respect to food safety requires the agency to “protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled.”42 Specifically, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) estab- lishes safety standards for processed and other non-meat foods (in- cluding produce, seafood, fish, and shellfish).43 The Agency is also solely in charge of pre-market authorization of any food additives to food or food-adjacent products and for the testing and controlling for any non-pesticide environmental or chemical contaminants.44 FDA’s force of field inspectors and laboratories, in turn, monitors and in- spects food and ensures that CFSAN’s standards are met.45 The main enabling food statutes for the agency are the Federal Food, Drug and 41. Emily M. Broad Leib & Margot J. Pollans, The New Food Safety, 107 CALIF. L. REV. 1173, 1175–76 (2019). 42. 21 U.S.C. § 393(b)(2) (1938). 43. Id. at §§ 348, 374; Center for Food Safety and Applied Nutrition; Statement of Organiza- tion, Functions, and Delegations of Authority, 73 Fed. Reg. 191 (Jan. 2, 2008). 44. 21 U.S.C. § 321(s) (defining food additives as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a com- ponent or otherwise affecting the characteristic of any food”). 45. See Office of Regulatory Affairs, U.S. FOOD & DRUG ADMIN. (last updated May 11, 2023), https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs [https://perma.cc /Y37P-94SM] (noting that the Office of Regulatory Affairs is the lead office for all agency field activities, including inspections of regulated products). 2024] Bystanders to a Public Health Crisis 301 Cosmetic Act (FDCA),46 the 1958 Food Additives Amendment to the FDCA, and the Food Safety and Modernization Act (FSMA).47 In addition to its sole responsibilities, FDA also implements por- tions of many statutes in conjunction with other agencies.48 These regulatory responsibilities are most frequently shared with USDA. FDA shares jurisdiction with the Department of Commerce over reg- ulating fish and seafood, where FDA has implemented a voluntary compliance program under the Hazard Analysis and Critical Control Points (HACCP) system that provides process control to prevent food safety problems.49 FDA is also charged with enforcing EPA’s toler- ance limits for pesticide residue in the foods under its jurisdiction.50 Due to its strong rulemaking and enforcement authority under the FDCA and FSMA and the fact that it solely regulates over 80% of all food, FDA is often considered “the” food safety agency. Despite these powers, however, FDA has been slow to respond effectively to new and emerging food safety threats due to a variety of challenges. First, to a degree, FDA is subject to a dual mandate to protect both food producers and food consumers.51 When faced with multiple contradictory goals, agencies “frequently resolve . . . interstatutory conflicts by prioritizing their primary mission and letting their sec- ondary obligations fall by the wayside.”52 And because FDA is sub- ject to intense industry lobbying by “Big Food,” it often defaults to working with industry, rather than enforcing standards against in- dustry.53 Beyond that, FDA’s effectiveness on food safety issues is often im- peded by its structure. Although FDA has oversized responsibilities for food safety, food in general, and safety in particular, are only a minor component of the agency’s mission, workforce, and funding. 46. 21 U.S.C. §§ 321–399 (1938). 47. Id. § 350(g). 48. Merrill & Francer, supra note 13, at 92. 49. See Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 60 Fed. Reg. 65,095 (Dec. 18, 1995) (codified at 21 C.F.R. §§ 123, 1240). 50. 21 U.S.C. § 346a (1938). 51. Gabriela Steier, Dead People Don't Eat: Food Governmentenomics and Conflicts-of- Interest in the USDA and FDA, 7 PITT. J. ENV’T PUB. HEALTH L. 1, 32 (2012). 52. Kelly D. Brownell & Kenneth E. Warner, The Perils of Ignoring History: Big Tobacco Played Dirty and Millions Died. How Similar is Big Food?, 87 MILBANK Q. 259, 274–76 (2009) (re- counting several clashed between FDA and “Big Food” lobbying efforts); Daniel G. Aaron, The Fall of FDA Review, 22 YALE J. HEALTH, POL'Y, L., & ETHICS 95, 157 (2023) (“It is hard to think of a system more favorable to industry than self-affirmed GRAS, at least in the short-term.”). 53. J.R. DeShazo & Jody Freeman, Public Agencies as Lobbyists, 105 COLUM. L. REV. 2217, 2220 (2005). 302 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 CFSAN’s budget for food safety is a mere 1.8% of FDA’s total budg- et—or only $128.2 million for 2023.54 Even accounting for all food activities beyond CFSAN (such as field inspections), the total food budget still only amounts to a mere 18% of the agency’s overall funding.55 It is an open secret in Washington that “regulating food is simply not a high priority at the agency,” and that, as the former act- ing commissioner of FDA put it, “[t]he food program is on the back burner.”56 FDA has jurisdiction over more than “53,000 establish- ments that produce, process, and store food,” and over another “750,000 restaurants, grocery stores, and other retail” businesses under its jurisdiction,57 while CFSAN currently has less than 900 employees in total, and only a handful of them are field inspectors.58 As a result, where USDA inspects production facilities under its ju- risdiction daily, FDA can only inspect a limited number of facilities on a once-every-three-to-five-years schedule.59 FDA inspections therefore cover only a fraction of domestic products on the market and an even smaller share of imports. Due to all these impediments, instead of direct enforcement, the Agency often relies on self-monitoring and good faith compliance by industry.60 It has implemented numerous voluntary programs, pur- suant to which food producers may, but are not required to, consult the Agency on compliance issues and can instead self-certify compli- 54. See FDA Seeks $7.2 Billion to Protect and Advance Public Health by Enhancing Food Safety and Advancing Medical Product Availability, U.S. FOOD & DRUG ADMIN. (Mar. 9, 2023), https://www.fda.gov/news-events/press-announcements/fda-seeks-72-billion-protect-and- advance-public-health-enhancing-food-safety-and-advancing-medical [https://perma.cc/TN5P -FVRR]; see also FY 2023 FDA Budget Summary, U.S. FOOD & DRUG ADMIN. (2023), https://www.fda.gov/media/157193/download?attachment [https://perma.cc/Y8Y3-NKRJ]. 55. Mark Von Eisenburg, Christina Badaracco & Kelly L. George, Amid Growing Safety Issues in America’s Food Supply, the FDA’s Proposal for a New Human Foods Program Presents Oppor- tunities for Stakeholders to Act, AVALERE (Feb. 23, 2023), https://avalere.com/insights/fda- human-foods-program-redesign-would-centralize-food-safety-efforts#:~:text=(While%20food %20regulation%20relies%20solely,drug%20and%20device%20user%20fees [https://perma.cc/ZY89-3PAV]. 56. Helena Bottemiller Evich, The FDA’s Food Failure, POLITICO (Apr. 8, 2022), https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/ [https://perma.cc/A2M2-95YV]. 57. Michael R. Taylor, Preparing America's Food Safety System for the Twenty-First Centu- ry—Who is Responsible for What When it Comes to Meeting the Food Safety Challenges of the Consumer-Driven Global Economy? 52 FOOD & DRUG L.J. 13, 16, n. 12 (1997). 58. A. MILLER & T. NORDENBERG, ENCYCLOPEDIA OF FOOD SCIENCES AND NUTRITION 2594 (Benja- min Caballero ed., 2nd ed. 2003). 59. Taylor, supra note 57, at 16. 60. Id. 2024] Bystanders to a Public Health Crisis 303 ance with the applicable standards and regulations.61 Even when FDA learns of violations, its most frequent response is to issue a non- enforceable opinion letter and to work with the food producer on voluntary phase-outs.62 Lastly, in the unlikely event that FDA de- cides to act on new food safety issues (or new information about a food safety issue), its rule-making process is extremely slow and cumbersome—“not your run-of-the-mill slow-churning Washington bureaucracy” but “so slow, it’s practically in its own league.”63 In short, “[t]here is a remarkable level of consensus that the agen- cy is simply not working,” and both “[c]urrent and former officials and industry professionals use[] terms like ‘ridiculous,’ ‘impossible,’ ‘broken,’ ‘byzantine’ and ‘a joke’ to describe the state of food regula- tion at FDA.”64 Despite its perceived status as the main food regula- tory body, therefore, FDA is clearly not currently capable of respond- ing to new food contaminants and addressing safety concerns in any meaningful way. 2. Food Safety and Inspection Service The Food Safety and Inspection Service (FSIS) is one of USDA’s 18 agencies. Established by the Secretary of Agriculture in 1981,65 FSIS is charged with regulating meat, poultry, and eggs through the in- 61. See, e.g., U.S. DEPT. OF HEALTH & HUM. SERV., GUIDANCE FOR INDUSTRY: THE JUDICIOUS USE OF MEDICALLY IMPORTANT ANTIMICROBIAL DRUGS IN FOOD-PRODUCING ANIMALS 3 (2012) (discussing the FDA voluntary plan to phase out the use of antibiotics in food production). See also Katya S. Cronin, FDA-Approved: How PFAS-Laden Food Contact Materials are Poisoning Consumers and What to do About it, 6 BUS. ENTREPRENEURSHIP & TAX L. REV. 117, 137 (2022) (discussing the problem of industry certifying its food additive ingredients as “generally recognized as safe” without any FDA oversight). 62. See, e.g., Opinion Letter from the Office of Food Additive Safety Center for Food Safety and Applied Nutrition on Use of Food Additives on Paper and Paperboard to Keller & Heckman LLP (Oct. 01, 2019); Opinion Letter from the Office of Food Additive Safety Center for Food Safety and Applied Nutrition Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (July 29, 2020). 63. Evich, supra note 56. See also Jonathan A. Havens, What Happens When FDA Delays a Rule? Menu Labeling as a Case Study, FOOD & DRUG LAW INST. UPDATE MAG. (Nov./Dec. 2017) https://www.fdli.org/2017/12/happens-fda-delays-rule-menu-labeling-case-study/ [https://perma.cc/4D53-XMLZ] (discussing FDA’s four-year delay in finalizing a menu labeling rule, followed by another four years of delaying its implementation). 64. Evich, supra note 56. 65. The agency was established pursuant to authority under 5 U.S.C. § 301 and Reorganiza- tion Plan No. 2 of 1953, 18 Fed. Reg. 3219 (codified at 5 U.S.C. § 901). See The Daily Journal of the United States Government, FEDERAL REGISTER, https://www.federalregister.gov/agencies /food-safety-and-inspection-service [https://perma.cc/77R2-GRMC] (last visited Apr. 19, 2024). 304 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 spection of processing operations and the approval of product labels under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA).66 Under this authority, FSIS inspects slaughterhouses, meat, poultry, and egg processors, and other food processors whose products con- tain a certain percentage of meat as an ingredient.67 FSIS is required to inspect every single animal carcass intended for food sale within the United States and any product subject to FSIS jurisdiction that has not undergone inspection is per se adulterated and subject to seizure.68 In addition to this continuous inspection mandate, FSIS is charged with pre-market approval and labeling for most meat and poultry products.69 FSIS shares jurisdiction over egg products and processed food containing meat as an ingredient with FDA.70 Although the main concern for FSIS inspectors is biological con- tamination—the presence of which is assessed through a combina- tion of visual inspections and microbial testing—FSIS also inspects food products under its jurisdiction for chemical hazards, such as natural toxins, unapproved food or color additives, or drug resi- dues.71 Additionally, FSIS enforces the pesticide residue tolerances set by EPA through USDA’s National Residue Program, which con- sists of testing and monitoring for the occurrence of pesticide resi- due in domestic and imported meat, poultry, and egg products. The program’s enforcement mechanism permits FSIS to seize non- compliant products.72 In some respects, FSIS is well-positioned to serve as an effective check on food safety. For one, FSIS’s budget is large—nearly $1.5 bil- lion for 2023—and 80% of it is spent on salary and benefits for in- spection personnel.73 FSIS employs more than 6500 full-time in- 66. 21 U.S.C. §§ 455, 457, 603, 604, 1034, 1036. 67. Id. 68. 21 U.S.C. § 604. 69. 21 C.F.R. 317.4. 70. 21 U.S.C. § 1034(d) (discussing the split of authority between the Secretary of Agricul- ture (i.e. FSIS) and the Secretary of Health and Human Service (i.e. FDA). See also U.S. FOOD & DRUG ADMIN., CPG Sec. 565.100 FDA Jurisdiction Over Meat and Poultry Products (Nov. 2005), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec- 565100-fda-jurisdiction-over-meat-and-poultry-products [https://perma.cc/KTC5-225F]. 71. 9 C.F.R. 417.2(b)(1). 72. U.S. DEP’T OF AGRIC. FOOD SAFETY & INSPECTION SERV., FSIS DIRECTIVE 8410.1 REV. 6, DETENTION AND SEIZURE (2014); 9 C.F.R. 309.16. 73. See U.S. DEP’T OF AGRIC., FY 2023 BUDGET SUMMARY at 65–68. 2024] Bystanders to a Public Health Crisis 305 spectors to conduct these inspections in about 6200 plants.74 FSIS has large laboratory capabilities and conducts testing in both federal and non-federal labs through its Accredited Laboratory Program.75 FSIS also benefits from the research work of other USDA agencies and has the advantage that its entire department is focused on food and agriculture. Lastly, FSIS has at its disposal a wide array of en- forcement mechanisms, including issuing noncompliance records, prompting voluntary recalls, condemning diseased animals, detain- ing adulterated misbranded, or otherwise violative food products under its jurisdiction, initiating administrative control actions, with- holdings, and suspensions, or engaging in civil seizures.76 FSIS’s work, however, has also been subject to considerable criti- cism. Most importantly, scholars point out that the agency is suscep- tible to severe regulatory capture—the process by which “organized interest groups successfully act to vindicate their goals through gov- ernment policy at the expense of the public interest.”77 For one, USDA’s overall institutional mission, which trickles down to FSIS, fo- cuses on the promotion of meat, dairy, and egg production and con- sumption, and this goal can often be at odds with safety regulation and policing violations.78 More troublingly, there is a well- established “revolving door” practice under which former food in- dustry lobbyists and executives are hired by the agency in key posi- tions but continue to maintain their old ties and allegiances to the industry in the hopes of future lucrative employment after their gov- ernment tenure.79 Investigations have described FSIS as “[a]n old boys club with a revolving door ‘between the USDA and FSIS, and the 74. See Food Inspector, FOOD SAFETY & INSPECTION SERV. (last updated Aug. 29, 2023), https://www.fsis.usda.gov/careers/career-profiles/food-inspector [on file with the Journal]. See also Taylor, supra note 57, at 16. 75. See Laboratories & Procedures, FOOD SAFETY & INSPECTION SERV. (last updated Apr. 05, 2018), https://www.fsis.usda.gov/science-data/laboratories-procedures [on file with the Journal]. 76. See Quarterly Enforcement Reports, FOOD SAFETY & INSPECTION SERV. (last updated Mar. 12, 2024), https://www.fsis.usda.gov/inspection/regulatory-enforcement/quarterly- enforcement-reports [on file with the Journal]. See also 9 C.F.R. § 500.1. 77. Michael A. Livermore & Richard L. Revesz, Regulatory Review, Capture, and Agency Inac- tion, 101 GEO. L.J. 1337, 1340 (2013). 78. Zoe A. Bernstein, The Fight over Frankenmeat: The FDA as the Proper Agency to Regulate Cell-Based “Clean Meat,” 86 BROOKLYN L. REV. 593, 601 (2021). 79. See, e.g., Alex Kotch, Revolving Door: Food Industry Lobbyists Swarm USDA to Shape Wel- fare, Visa Policies, TYT NETWORK (Mar. 22, 2018), https://legacy.tyt.com/2018/03/22 /revolving-door-food-industry-lobbyists-swarm-usda-to-shape-welfare-visa-policies/ [https://perma.cc/4SFM-MAMV]. 306 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 captains of the meat industry,’” which often results in “large meat producers […being] given a ‘pass’ thanks to their high-paid lobby- ists.”80 For example, the former head of FSIS, Al Almanza, permitted JBS rotten beef to be imported into the United States in early 2017 and took 90 days to act on the issue.81 In July 2017, he left FSIS to work for JBS.82 Similarly, an investigation revealed that Rebeckah Adcock—a former pesticide lobbyist—continued working on behalf of the pesticide industry when serving as a senior advisor to the Sec- retary of Agriculture focusing on regulatory policy.83 The former head of FSIS, Michael Taylor, also spent years working in high- ranking positions in Monsanto.84 As a result of these deficiencies, for decades, FSIS has been satisfied with entering into voluntary agree- ments with industry, rather than countering emerging threats to food safety proactively and forcefully. 3. The Environmental Protection Agency Housed within the Department of the Interior, EPA is a fairly re- cent addition to the Executive Branch and one whose mission is “to protect human health and the environment.”85 There are two main programs within EPA that touch upon food safety—water regulation and pesticide regulation. EPA regulates water pollution under the Clean Water Act, which, as relevant to food production, covers the regulation of wastewater management and the discharge of animal waste from some concen- trated animal feed operations.86 Additionally, EPA has special juris- diction over drinking water under the Safe Drinking Water Act of 80. Captured: How Agribusiness Controls Regulatory Agencies and Harms Producers and Con- sumers, ORG. FOR COMPETITIVE MKTS. (Aug. 24, 2020), https://competitivemarkets.com/wp- content/uploads/2020/08/Regulatory-Capture-Paper_Final.pdf [https://perma.cc/6CDS- 5PSG] (describing conversations with FSIS officials, who confirmed these troubling trends). 81. Id. 82. Id. 83. Alexander Rony, Here’s What Our Supporters Found in Former Lobbyist’s Emails at the USDA, SIERRA CLUB (Aug. 26, 2020), https://www.sierraclub.org/articles/2020/08/heres- what-our-supporters-found-former-lobbyists-emails-usda [https://perma.cc/4T8C-62F2]. 84. MARION NESTLE, FOOD POLITICS: HOW THE FOOD INDUSTRY INFLUENCES NUTRITION AND HEALTH 101-102 (2007). 85. Our Mission and What We Do, U.S. ENV’T PROT. AGENCY, https://www.epa.gov/aboutepa/our-mission-and-what-we-do [https://perma.cc/DGQ5- CWRX]. 86. Animal Feeding Operations (AFOs), EPA (2023), https://www.epa.gov/npdes/animal- feeding-operations-afos [https://perma.cc/Y72T-5EQ2]. 2024] Bystanders to a Public Health Crisis 307 1974.87 The Act requires EPA to set and enforce standards for public drinking water for over 90 contaminants, known as the National Primary Drinking Water Regulations (NPDWR).88 Notably, regula- tion of bottled water falls outside EPA’s jurisdiction and is instead in FDA’s purview.89 The Office of Pesticide Programs (OPP) is charged with overseeing the registration of pesticides and setting pesticide tolerance limits for residue found on food.90 EPA derives its authority over pesti- cides from FIFRA, the FDCA, and the Food Quality Protection Act of 1996 (FQPA).91 Under FIFRA, no pesticide may be placed in inter- state commerce unless the OPP has issued a preauthorization.92 OPP also sets tolerances of pesticide residue left on food under the FDCA and FQPA.93 In doing so, OPP must evaluate a pesticide’s potential for harm to human health by taking into consideration all known sources of exposure and the special susceptibilities of infants and children.94 FSIS and FDA must enforce EPA’s tolerance limits in the foods over which each agency otherwise has jurisdiction and, if a food is found to exceed the tolerance set by EPA, the commodity be- comes subject to seizure.95 EPA has several institutional advantages over FSIS and FDA in its ability to manage emerging threats. First, EPA’s budget is magni- tudes larger than that of both FSIS and CFSAN—totaling at $10 bil- lion for 2023.96 While not all of these funds go to food-specific initia- tives, both the Pesticide Program and the Safe Drinking Water Initiative are top priorities for the agency and receive a significant share of the budget appropriations.97 EPA also has a sizable work- 87. 42 U.S.C. § 300f. 88. 40 C.F.R. 141. 89. 21 C.F.R. 165.110 (2023). 90. Setting Tolerances for Pesticide Residues in Food, U.S. ENV’T PROT. AGENCY (last updated May 11, 2023), https://www.epa.gov/pesticide-tolerances/setting-tolerances-pesticide- residues-foods#:~:text=To%20ensure%20the%20safety%20of,in%20foods%20and%20 animal%20feeds [https://perma.cc/6G4U-QPEK]. 91. 21 U.S.C. §§ 301, 321, 331, 333, 342, 346a, 348. 92. 7 U.S.C. § 136a(c)(5)(D). 93. 21 U.S.C. § 346a(b)(2)(A)(ii). 94. 21 U.S.C. § 346a. 95. Summary of the Federal Food, Drug, and Cosmetic Act, U.S. ENV’T. PROT. AGENCY (last up- dated Sept. 6, 2023), https://www.epa.gov/laws-regulations/summary-federal-food-drug- and-cosmetic-act [https://perma.cc/U3L2-C8XE]. 96. See EPA’s Budget and Spending, U.S. ENV’T. PROT. AGENCY (last updated July 26, 2023), https://www.epa.gov/planandbudget/budget [https://perma.cc/XW3N-RUCZ]. 97. See, e.g., Safe Drinking Water Act, U.S. ENV’T. PROT. AGENCY (last updated Jan. 29, 2024) https://www.epa.gov/sdwa#:~:text=Protecting%20America's%20drinking%20water%20is,t 308 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 force—15,115 people—and built-in synergies between its various components and programs.98 And it has an accumulated knowledge bank and decades of experience addressing toxic environmental con- taminants. Importantly, the agency’s mission is focused entirely on the protection of the public, rather than the prosperity of its regulat- ed industries, which creates fewer opportunities for conflict of inter- est and divided loyalties. Further, because EPA’s focus is not on food safety, the agency is less likely to become subject to regulatory cap- ture by food industry players (albeit it is still susceptible to regulato- ry capture by the chemical industry).99 Despite these institutional advantages, EPA’s effective authority over food safety is not necessarily superior to other agencies. Be- cause its focus is not on food safety, EPA is only able to regulate food to the degree that it has explicit jurisdiction over specific issues. Therefore, it has historically needed grants of augmented authority by an Act of Congress before it can take the lead in addressing emerging food safety threats.100 4. Other Agency Actors Numerous other agencies have a stake in a specific corner of the food safety system. Most have no regulatory function and focus pri- marily on research. The Center for Disease Control and Prevention, for example, which is housed in the Department of Health and Hu- man Services (HHS), systematically investigates foodborne illnesses, including those caused by pathogens, chemicals, and other contami- nants.101 HHS’s National Institute of Health conducts food safety re- hat%20strengthen%20public%20health%20protection [https://perma.cc/NE59-XLQF] (list- ing safe drinking water as a “top priority” for EPA); U.S. ENV’T PROT. AGENCY, EPA-190-S-22-001, EPA BUDGET IN BRIEF at 14, 47–48 (2022) (requesting an additional $25.6 million for Pesticide Enforcement, $14 million for Pesticide Program Implementation grants, and $4.9 million for enabling the Pesticide Program to integrate ESA requirements in conducting risk assess- ments). 98. See EPA’s Budget and Spending, EPA (last updated July 26, 2023), https://www.epa.gov/planandbudget/budget [https://perma.cc/M5BW-GLR4]. 99. See, e.g., Lindsey Dillon, et al., The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture, 108 AM. J. PUB. HEALTH S89 (2018). 100. See Part II(C), infra. 101. See Mission, Role, and Pledge, CTRS. FOR DISEASE & CONTROL (last reviewed Apr. 29, 2022), https://www.cdc.gov/about/organization/mission.htm [https://perma.cc/R2N7- 5HGY]. 2024] Bystanders to a Public Health Crisis 309 search.102 USDA’s Agricultural Research Service (ARS) develops tests and processes to keep the food supply safe and to reduce and control pathogens and toxins in agricultural products.103 The Na- tional Institute of Food and Agriculture researches issues of nutri- tion and foodborne illnesses,104 the Food Nutrition Service provides food assistance and conducts food safety research,105 and the Animal and Plant Health Inspection Service conducts research into pest con- trol, soil quality, and plant health.106 Some agencies do have a limited stake in regulation and enforce- ment. Within the Department of Agriculture, the Agricultural Mar- keting Service operates a voluntary inspection system for the grad- ing of eggs,107 while the Grain Inspection, Packers, and Stockyards Administration inspects grain for safety and quality.108 The National Marine Fisheries Service under the auspices of the Commerce De- partment continues to co-regulate fisheries and seafood jointly with FDA,109 the Federal Trade Commission (under the Department of Labor) regulates food advertising,110 the U.S. Customs and Border Patrol (under the Department of Homeland Security) enforces in- spections and seizures of imports under USDA and FDA regula- tions,111 and the Consumer Product Safety Commission has overlap- ping jurisdiction with FDA over regulating the chemical safety of products that come in direct contact with food.112 Because these agencies’ functions are confined to discrete issues, none of these ac- 102. Division of Occupational Health and Safety, NAT’L INSTS. OF HELATH, https://ors.od.nih.gov/sr/dohs/safety/food_water/Pages/food_safety.aspx [https://perma.cc/LTZ4-5PYD] (last visited Apr. 18, 2024). 103. About ARS, U.S. DEP’T OF AGRIC. (last modified Fed. 24, 2024), https://www.ars.usda.gov/about-ars/ [https://perma.cc/4RY3-8W8E]. 104. Food, Conservation, and Energy Act of 2008, Pub. L. 110–234, 122 Stat. 936 (codified as 7 U.S.C. § 2011). 105. 7 C.F.R. § 210.13 (2013). See also Food and Nutrition Service, Food Safe Schools: Creat- ing a Culture of Food Safety, U.S. DEP’T OF AGRIC. (last updated Jan. 9, 2024), https://www.fns.usda.gov/fs/foodsafeschools#:~:text=The%20Food%2DSafe%20Schools%2 0Action,safety%20cultures%20in%20their%20communities [https://perma.cc/UN5C-LVL8]. 106. Animal & Plant Health Inspection Serv., Our Mission, U.S. DEP’T OF AGRIC., https://www.aphis.usda.gov/aphis/home/ [https://perma.cc/99V7-4JGH] (last visited Apr. 18, 2024]. 107. 7 C.F.R. § 2.79 (2020). 108. 9 C.F.R. § 201.4. 109. Magnuson–Stevens Fishery Conservation and Management Act of 2006, Pub. L. 117- 328, 120 Stat. 3575, codified as 16 U.S.C. Ch. 38. 110. 15 U.S.C. §§ 52–55. 111. 19 C.F.R. §§ 12.110 - 12.117 (2016). 112. Consumer Product Safety Improvement Act of 2008, Pub. L. 110–314, 86 Stat. 1207, as codified in 15 U.S.C. § 2051. 310 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 tors is able to take major steps towards addressing the issue of emerging food contaminants. C. More Is Not Always Better The failures of the current federal food safety system—all stem- ming from the fractured and overpopulated regulatory scheme—are numerous and well-documented. First, although theoretically working toward the same goal of con- sumer safety, each individual agency has unique interests and focus, which often leads to agency infighting and jurisdictional postur- ing.113 Recently, both FDA and USDA asserted exclusive jurisdiction over the regulation of genetically engineered and cultured cell “meat.”114 This type of turf-claiming could in turn lead to overregu- lation (in the form of multiple requirements that industry must meet),115 uneven regulation (with one agency enforcing a standard more frequently or zealously than another),116 or inconsistent regu- lation (with mutually-incompatible expectations).117 This activity, at a minimum, leads to “myopic risk management,” where each agency looks at a particular problem through the lens of a specific policy priority and often misses the bigger picture of how various risks and aspects associated with a problem interact with each other.118 Second, the antiquated system of food safety legislation creates absurd divisions and inefficient overlaps in authority. For example, the CDC has primary jurisdiction over investigating outbreaks of 113. See, e.g., Diane E. Hoffmann, The Biotechnology Revolution and Its Regulatory Evolu- tion, 38 DRAKE L. REV. 471, 543 (1988) (describing the fight between FDA and USDA over genet- ically modified products). 114. Sarah Luther, From Un-Coordinated to Efficient: A Proposal for Regulating GE Products in a Way that Meets the Needs of Consumers, Producers, and Innovators, 20 VT. J. ENV’T. L. 32, 50- 51 (2019); Jaden Atkins, Regulating the Impending Transformation of the Meat Industry: “Cul- tured Meat,” 24 J. TECH. L. & POL’Y 1, 3 (2020). 115. See generally Stephanie Neitzel, One Size Fits All: A Federal Approach to Accurate Label- ing of Consumer Products, 23 J. HEALTH CARE L. & POL’Y 87, 103 (2020) (arguing that food label- ing requirements “under the current system [lead to] businesses [being] needlessly burdened by overregulation and consumers are left utterly confused or even misled.”). 116. George Kimbrell, Cutting Edge Issues in 21st Century Animal Food Product Labeling, 27 DRAKE J. AGRIC. L. 179, 182 (2022) (discussing the variable and uneven requirements applied to different food manufacturers under the current system of fragmented and decentralized food regulation). 117. See STAFF OF S. COMM. ON GOV’T AFF., 95th Cong., STUDY ON FEDERAL REGULATION: REGULATORY ORGANIZATION 113 (Comm. Print 1977) (concluding that the U.S. food safety system is “often duplicative, sometimes contradictory, undeniably costly, and unduly complex.”). 118. Broad Leib & Pollans, supra note 41, at 1177. 2024] Bystanders to a Public Health Crisis 311 foodborne illness, but FDA and USDA have jurisdiction to order a re- call of the contaminated foods.119 While USDA regulates red meat and poultry, FDA regulates “game” species like deer, buffalo, ostrich, and pheasant.120 While USDA regulates cattle, FDA regulates milk. FDA has jurisdiction over plants producing cheese pizza, while FSIS has jurisdiction over plants making pepperoni pizza.121 The jurisdic- tion over eggs is even more inexplicable, as FDA has jurisdiction over in-shell eggs, AMS has jurisdiction over grading the quality of in-shell eggs, FSIS has jurisdiction over egg products, and FDA has jurisdic- tion over products made with eggs.122 These and many other juris- dictional absurdities have necessitated the use of hundreds of costly and cumbersome interagency Memoranda of Understanding (MOUs), which attempt to outline the basic division of responsibilities and rules of engagement and cooperation.123 Third, and most relevant in the case of emerging food safety threats, the highly populated food safety field often results in less ac- tion, not more, due to the phenomenon psychologists call the “by- stander effect” or “bystander apathy.”124 The theory of bystander apathy was developed in the aftermath of the horrific murder of Kit- ty Genovese in 1964.125 According to reports at the time (which may have been apocryphal), 38 of Ms. Genovese’s neighbors watched and listened as she was being killed over a half hour, yet did not help 119. RENEE JOHNSON, CONG. RSCH. SERV., R42885, FOOD SAFETY ISSUES FOR THE 114TH CONGRESS 1, 3 (2015). 120. Taylor, supra note 57, at 16. 121. Id. at 18. 122. Id. 123. See, e.g., Memorandum of Understanding Between the U.S. Department of Agriculture Food Safety And Inspection Service and the U.S. Department of Health and Human Services Centers for Disease Control and Prevention National Center For Emerging and Zoonotic Infec- tious Diseases National Center For Environmental Health and Agency for Toxic Substances and Disease Registry regarding Foodborne Health Hazards Assessments Associated with FSIS- Regulated Product (Jan. 24, 24 2014), https://www.fsis.usda.gov/sites/default/files/media _file/2020-11/MOU-FSIS-CDC-ATSDR.pdf [on file with the Journal] (detailing agencies collabo- ration on foodborne illness investigations, including food tracebacks, assessments of FSIS- regulated establishments, food recalls and alerts to consumers); Memorandum of Understand- ing Between the U.S. Department of Agriculture Food Safety and Inspection Service and the U.S. Department Of Health And Human Services Food And Drug Administration, (Mar. 24, 2015), https://www.fsis.usda.gov/sites/default/files/media_file/2020-11/Memorandum%20of%20 Understanding%20betwee &n%20FSIS%20and%20FDA.pdf [on file with the Journal] (outlin- ing rules for cooperation and collaboration “on the review of submissions each Participant re- ceives regarding the use of food ingredients used in the production of or on a meat, poultry, or egg product.”). 124. Bibb Latane & John M. Darley, Bystander “Apathy,” 57 AM. SCIENTIST 244, 244 (1969). 125. Id. 312 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 or even call the police.126 Examining the perplexing nature of such inaction, the theory of bystander apathy poses that an emergency presents a high-risk, low-reward situation that requires instant and decisive action, but that prompts bystanders to ignore what is hap- pening by distorting their perceptions to underestimate their re- sponsibilities for coping with it.127 This effect is magnified when there are multiple bystanders present, which further diffuses the sense of responsibility and the desire to act outside one’s routine.128 In the world of administrative law, a similar phenomenon of dif- fused responsibility is captured by the term “regulatory commons.” According to the theory of regulatory commons, “when social ills match no particular political-legal regime or jurisdiction, but instead encounter fragmented political-legal structures, predictable incen- tives arise for potential regulators to opt against investing in such regulatory opportunities.”129 In the food space, one example of the regulatory commons problem occurs with aquaculture, where many regulators—EPA, the National Marines and Fisheries Service, FDA, and the United States Army Corp of Engineers—all arguably have ju- risdiction.130 Thus, “[n]o single regulator [] is perceived as the regu- latory leader and hence looked to for creation of regimes to deal with transboundary or ecosystem aquaculture risks, nor is any particular regulator likely to be blamed for harms that could result from aqua- culture,” and so the field is heavily underregulated.131 Regulatory commons exist not just in a defined regulatory area, but also when regulators are faced with a novel yet diffuse problem.132 The issue of environmental contaminants in food is just such a problem. Because of the interconnectedness between the environment, natural re- sources, food production, food safety, and public health, responsibil- ity for the issue lies at the intersection of many agencies’ jurisdic- tions and fails to neatly fit into a single one of these jurisdictions. Issues of toxic contamination of food are also usually of the high- profile, high-complexity, and low-reward variety,133 making them 126. Id. 127. Id. at 246. 128. Id. at 244. 129. William Buzbee, Recognizing the Regulatory Commons: A Theory of Regulatory Gaps, 89 IOWA L. REV. 1, 6 (2003-2004). 130. Id. at 9. 131. Id. 132. See id. at 13 (describing global warming as a regulatory commons problem). 133. See Part III(D) infra. 2024] Bystanders to a Public Health Crisis 313 vastly unattractive for any one agency to step out of its jurisdictional wheelhouse to take the lead. Past examples of toxic contaminants in food illustrate this difficul- ty. Polychlorinated biphenyls (or PCBs) are a group of chemicals widely used in both industrial and consumer products from 1929 to 1979.134 As early as 1939, there were widely publicized studies that linked PCBs to devastating human health consequences.135 By the 1950’s, health authorities and industry alike were warning the pub- lic of likely contamination of food by PCBs.136 In the 1960s, research demonstrated that there were traces of PCBs globally in even the most remote areas of the Arctic.137 Yet, in the face of mounting chemical manufacturers’ opposition and the overall complexity and ubiquity of the problem, no federal agency took any actions to regu- late or restrict the use of PCBs or their spread in the food supply, un- til Congress voted in 1976 to ban within 3 years the manufacture of PCBs and to give additional powers to EPA to regulate these hazard- ous chemicals.138 Subsequently, EPA took up the task of “bring[ing] under control the vast majority of PCBs still in use, [which] will help prevent further contamination of our air, water and food supplies from a toxic and very persistent man-made chemical.”139 This effort continues to this day. A remarkably similar story can be told about another group of chemicals—Dichlorodiphenyltrichloroethane (DDT) and other chlo- rinated hydrocarbon compounds, like dieldrin, aldrin, and endrin. First manufactured in 1874, these chemicals’ effectiveness as insec- ticides was discovered in 1939 and, shortly thereafter, they were 134. Learn about Polychlorinated Biphenyls, EPA (last updated Apr. 2, 2023), https://www.epa.gov/pcbs/learn-about-polychlorinated-biphenyls [https://perma.cc/4JN2- DG7K]. 135. Cecil Drinker, Further Observations on the Possible Systemic Toxicity of Certain of the Chlorinated Hydrocarbons with Suggestions for Permissible Concentrations in the Air of Work- rooms, 21 J. INDUS. HYGEINE & TOXICOLOGY 155 (1939). 136. Gerald Markowitz, From Industrial Toxins to Worldwide Pollutants: A Brief History of Polychlorinated Biphenyls, 133 PUB. HEALTH REPS. 721, 723 (2018). 137. What are PCBs?, NAT’L OCEANIC & ATMOSPHERIC AGENCY (last updated Jan. 20, 2023), https://oceanservice.noaa.gov/facts/pcbs.html#:~:text=PCBs%2C%20or%20polychlorinated %20biphenyls%2C%20are%20industrial%20products%20or%20chemicals.&text=PCB%20c hemicals%20were%20banned%20in,harm%20human%20and%20environmental%20health [https://perma.cc/US2D-E7EJ]. 138. Richard D. Lyons, House Votes Ban on Output of PCB’s Within 3 Years, N.Y. TIMES, Aug. 24, 1976, at 19. 139. Press Release, U.S. Env’t Prot. Agency, EPA Bans PCB Manufacture; Phase Out Uses (April 19, 1979), https://www.epa.gov/archive/epa/aboutepa/epa-bans-pcb-manufacture- phases-out-uses.html [https://perma.cc/96PT-64P3]. 314 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 produced in copious amounts and were sprayed on agricultural lands, over public spaces, and in private residences alike.140 By 1940, DDT in particular and chlorinated hydrocarbons in general were already demonstrated to be carcinogenic and to cause a slew of other health issues.141 Despite this, by the 1950s, these substances were heavily present in the U.S. food supply. In 1953, a medical re- searcher warned that “[e]xposure to this whole group of compounds is now universal in the United States, and it appears that few persons escape storage of these toxic agents in the body fat.”142 Despite hav- ing authority to regulate insecticides under FIFRA, neither USDA nor FDA took any meaningful steps to curtail the use of these substances. Indeed, USDA itself was one of the main “consumers” of insecti- cides.143 Over the course of thirteen years, from 1957 to 1970, USDA began very slowly phasing out only certain uses of DDT in limited settings.144 Like with PCBs, it took an Act of Congress—several, in fact—to first transfer regulatory authority over pesticides to the newly-created EPA and then to augment EPA’s authority to act on the issue under FIFRA, before the agency could take meaningful ac- tion in banning all DDT formulations and directing FDA and USDA to monitor food products for DDT and other chlorinated hydrocarbon residues.145 III. REGULATING PFAS: A CASE STUDY IN DYSFUNCTION AND DIFFUSED RESPONSIBILITY. “Can anyone believe it is possible to lay down such a barrage of poisons on the surface of the earth without making it unfit for all life?” Rachel Carson146 140. U.S. ENV’T PROT. AGENCY, EPA-540-1-75-022, DDT: A REVIEW OF SCIENTIFIC AND ECONOMIC ASPECTS OF THE DECISION TO BAN ITS USE AS A PESTICIDE at 251–256 (1975) (describing the regula- tory history of DDT until 1975). 141. Gerald Markowitz, supra note 136, at 722. 142. Morton S. Biskind, Public Health Aspects of the New Insecticides, 20 AM. J. DIGESTIVE DISEASES 331, 335 (1953). 143. EN’VT PROT. AGENCY, supra note 140. 144. Id. 145. Id. See also U.S. DEP’T AGRIC., FOOD SAFETY & INSPECTION SERV., CLG-CHC3.04, DETERMINATION OF CHLORINATED HYDROCARBONS (CHCS) AND CHLORINATED ORGANOPHOSPHATE HYDROCARBONS (COPS) WITH GEL PERMEATION CHROMATOGRAPHY (GPC) (2004) (setting standards for testing food products for the presence of chlorinated hydrocarbons). 146. Carson, supra note 37, at 8. 2024] Bystanders to a Public Health Crisis 315 A nearly identical story to the failures of the past is being written today—the tale of per- and polyfluoroalkyl substances, or PFAS. This section provides a brief overview of these substances and their presence in our food supply, reviews current PFAS regulation, and analyzes the unique regulatory challenges that these contaminants pose. A. Background on PFAS Per- and polyfluoroalkyl substances—also known as PFAS for short—are a class of thousands of synthetic chemicals that have been in use since the 1940s.147 Notably, these chemicals contain a carbon-fluorine bond—the strongest bond known in organic chemis- try—making them virtually indestructible and impervious to ex- treme conditions such as heat, water, erosion, and even radiation.148 These qualities make PFAS highly desirable in industrial and com- mercial applications, because they make products water-, oil-, and dirt-resistant.149 As a result, these chemicals are used in products ranging from firefighting foam to water-repellant clothing, cosmet- ics, and food contact materials like non-stick pans.150 PFAS’ indestructible bond has a darker side, however. It not only survives artificially created extreme conditions but also resists the natural processes of degradation.151 For this reason, these chemicals are classified as highly persistent and have been dubbed “forever chemicals”—absent an intentional action to filter or destroy them from a medium, they will likely stay there forever. Their widespread use in industrial and commercial applications, coupled with their ability to travel long distances in various environments, has further made these chemicals ubiquitous. PFAS are now present in the air, soil, water, wildlife, and 98% of humans, including in fetuses in utero.152 They have been found not only near sites of heavy indus- 147. See Cronin, supra note 61. 148. Id. at 121. 149. Id. 150. See, e.g., Juliane Glüge et al., An Overview of the Uses of Per- and Polyfluoroalkyl Sub- stances (PFAS), ENV’T SCI.: PROCESSES AND IMPACTS (2020). 151. See, e.g., Lena Vierke et al., Perfluorooctanoic Acid (PFOA) — Main Concerns and Regu- latory Developments in Europe from an Environmental Point of View, 23 ENV’T SCI. EUR., 2012, at 1, 6. 152. See Marie P. Krafft & Jean G. Riess, Per- and Polyfluorinated Substances (PFASs): Envi- ronmental Challenges, 20 CURRENT OP. IN COLLOID & INTERFACE SCI. 192, 192–212 (2015). 316 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 trial activity but also in otherwise pristine and remote locations, like the Arctic and atop Mt. Everest.153 PFAS are detrimental to human health. The two most widely used substances—PFOS and PFOA—have been proven to cause wide range of health issues, including kidney, testicular, and thyroid can- cer, reproductive and pregnancy complications, negative birth out- comes, high cholesterol, endocrinal disruptions, and immunotoxici- ty.154 The newer generation (or short-chain) PFAS, like GenX, are likewise linked to developmental delays, pregnancy loss and dis- rupted reproductive cycles, liver and kidney damage, hormonal and metabolic disruptions, and many others.155 Because these chemicals bioaccumulate in human tissue and could persist in the body for years, even small doses of them can prove fatal with chronic expo- sure.156 B. PFAS in Our Food Supply One of the main routes of human exposure to PFAS is through in- gestion of either contaminated drinking water or contaminated food.157 PFAS find their way into drinking water through direct dis- charge in water sources or through air and water dispersion from contaminated sites to more remote locations.158 A recent U.S. Geo- 153. Robert J. Letcher et al., Legacy and New Halogenated Persistent Organic Pollutants in Polar Bears from a Contamination Hotspot in the Arctic, 610–611 SCI. OF THE TOTAL ENV’T, 121, 121–136 (Supp. C 2018); Murray Carpenter, "Forever Chemicals,” Other Pollutants Found Around the Summit of Everest, WASH. POST (Apr. 17, 2021), https://www.washingtonpost.com /science/mt-everest-pollution/2021/04/16/7b341ff0-909f-11eb-bb49-5cb2a95f4cec_story .html [https://perma.cc/2U9Q-2NWX]. 154. Cronin, supra note 61, at 128. 155. Id. at 128-129. See also Laura Anderko & Emma Pennea, Exposures to Per-and Polyfluoroalkyl Substances (PFAS): Potential Risks to Reproductive and Children's Health, 50 CURRENT PROBS. IN PEDIATRIC & ADOLESCENT HEALTH CARE, Feb. 2020, at 1; Francesca Coperchini et al., Thyroid Disrupting Effects of Old and New Generation PFAS, FRONTIERS IN ENDOCRINOLOGY, Jan 2021, at 1. 156. Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS), NAT’L INST. OF HEALTH (last re- viewed Mar. 6, 2024), https://www.niehs.nih.gov/health/topics/agents/pfc/index.cfm [https://perma.cc/C467-CFRR]. 157. See, e.g., Herbert P. Susmann et al., Dietary Habits Related to Food Packaging and Popu- lation Exposure to PFASs, ENV’T HEALTH PERSP., Oct. 2019, at 1, 1–10. 158. SWRCB, PFAS – Frequently Asked Questions, at 4 (March 19, 2020), https://www.waterboards.ca.gov/pfas/docs/master_pfas_faq_mar.pdf [https://perma.cc/2S8M-YS9C]. 2024] Bystanders to a Public Health Crisis 317 logical Survey found PFAS present at detectable levels in nearly half of the nation’s tap water.159 PFAS end up in food through numerous routes. One is the migra- tion of PFAS from food contact materials—such as paper wrappers and containers, non-stick cookware, or food processing equipment— onto the food itself.160 Another is through contaminated soil, which may contain PFAS due to present-day or historic application of PFAS- contaminated biosolid fertilizers, spraying of PFAS-containing pesti- cides and biocides, use of PFAS-contaminated compost, or irrigation with PFAS-contaminated water.161 From the soil, PFAS gets taken up by plants, thus contaminating fresh produce and processed food made from such produce.162 Or they migrate further into animals— such as cows, pigs, and chickens—who eat contaminated plants, like grass or grain, and drink contaminated water.163 These animals in turn produce milk, eggs, or other products that likewise wind up contaminated.164 Fish and shellfish also easily pick up PFAS from their environment.165 As a result of the widespread presence, mobility, and persistence of PFAS in the environment and the many different food manufactur- ing practices that include the substances as an active ingredient, PFAS have now been found in beef, chicken, dairy, eggs, produce, fish, shellfish, and packaged goods, such as orange juice, butter, mi- crowave popcorn, and chocolate cake.166 Certifications such as or- 159. K.L. Smalling et al., Per- and Polyfluoroalkyl Substances (PFAS) in United States Tap Wa- ter: Comparison of Underserved Private-Well and Public-Supply Exposures and Associated Health Implications, ENV’T INT’L, June 2023, at 1, 5. 160. See generally Cronin, supra note 61. 161. See, e.g., Our Current Understanding of the Human Health and Environmental Risks of PFAS, EPA (last updated June 7, 2023), https://www.epa.gov/pfas/our-current-understanding -human-health-and-environmental-risks-pfas [https://perma.cc/QHR5-UXHP]. See also M. Brusseau et al., PFAS concentrations in soils: Background levels versus contaminated sites, SCI. TOTAL ENVIRON. (2020). 162. See, e.g., G. Jha et al., Per- and Polyfluoroalkyl Substances (PFAS) in Integrated Crop- Livestock Systems: Environmental Exposure and Human Health Risks, 18 INT’L J. ENV’T RES. & PUBLIC HEALTH 23 (2021). 163. Id. 164. Id. 165. EPA, supra note 161. 166. See, e.g., Tom Neltner, FDA Finds Surprisingly High Levels of PFAS in Certain Foods— Including Chocolate Cake (June 3, 2019), https://blogs.edf.org/health/2019/06/03/fda-high- levels-pfas-chocolate-cake/ [https://perma.cc/WYD2-RNZ2]. See also Tom Perkins, New Re- port Finds Most US Kale Samples Contain “Disturbing” Levels Of “Forever Chemicals”, GUARDIAN (June 30, 2023), https://www.theguardian.com/environment/2023/jun/30/kale-pfas-forever -chemicals-contamination [https://perma.cc/HR2M-394F]; Robin Lasters, et al., Home- 318 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 ganic, free-range, grass-fed, or sustainable do nothing to ensure lack of PFAS contamination, as such certifications cover only an isolated aspect of farming or food production that does not touch upon PFAS use or historic environmental contamination.167 C. Current Regulation of PFAS Although environmental contamination with PFAS dates to as ear- ly as the 1940s, scientific knowledge of the enormous ecological and health consequences of these chemicals came to be known only about a decade and a half ago.168 As is always the case, where sci- ence lags, regulation lags even farther behind. Some of the oldest-in- use long-chain substances—PFOS and PFOA—have been widely rec- ognized as extremely harmful and, through the efforts of both EPA and FDA, these chemicals were voluntarily phased out of production and use on the U.S. market by 2015.169 To date, however, no binding regulation exists covering these or any other PFAS compounds. The last two years have seen a strong push toward future regula- tion of PFAS driven by EPA’s PFAS Strategic Roadmap. In 2021, EPA initiated rule making efforts to include four PFAS under the Resource Conservation and Recovery Act, which would allow for cradle-to- grave clean-up of PFAS contamination.170 In 2023, it released a final rule under the Community Right-to-Know Act and the Pollution Pre- vention Act, removing the de minimis exemption for PFAS report- ing,171 and another final rule under the Toxic Substances Control Act, Produced Eggs: An Important Human Exposure Pathway of Perfluoroalkylated Substances (PFAS), 308 CHEMOSPHERE, Pt. 1, 2022, at 1. 167. See, e.g., Perkins, supra note 166; PFAS found in organic eggs in Denmark, DTU NAT’L FOOD INST. (January 23, 2023), https://www.food.dtu.dk/english/news/pfas-found-in-organic- eggs-in-denmark?id=789f9ba1-bdfc-4a7d-908b-fc6cccff4742 [https://perma.cc/3U6V-GU3N]; Evidence of PFAS in organic pasta sauces, ENV’T HEALTH NEWS (April 13, 2022), https://www.ehn.org/pfas-pasta-sauce-2657142422.html [https://perma.cc/4F42-9XR6]. 168. See Mark P. Nevitt & Robert V. Percival, Can Environmental Law Solve the “Forever Chemical” Problem?, 57 WAKE FOREST L. REV. 239, 242 (2022). 169. See PFOA Stewardship Program, No. EPA-HQOPPT-2006-0621, (EPA Jan. 25, 2006); United States, OECD PORTAL ON PER- AND POLYFLUORINATED CHEMICALS, https://www.oecd.org /chemicalsafety/portal-perfluorinated-chemicals/countryinformation/united-states.htm [on file with the Journal] (last visited Apr. 2, 2024). 170. Letter from EPA to Michelle Grisholm Lujan, New Mexico Governor, Responding to a Petition to list PFAS as Hazardous Wastes (Oct. 2021), https://www.epa.gov/system/files /documents/2021-10/oct_2021_response_to_nm_governor_pfas_petition_corrected.pdf [https://perma.cc/7CSP-Y42F]. 171. 40 C.F.R. § 372. See also Changes to TRI Reporting Requirements for Per-Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Concern, U.S. ENV’T PROT. AGENCY (last 2024] Bystanders to a Public Health Crisis 319 requiring reporting and record-keeping of PFAS use in a wide array of products.172 It also gave advance notice of a proposed future rule to include PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).173 And it proposed a National Primary Drinking Water Regulation pursuant to its Safe Drinking Water Act authority, which seeks to establish legally enforceable maximum contaminant levels for six PFAS present in drinking water.174 In January 2024, EPA fi- nalized a Significant New Use Rule under RCRA for 329 inactive PFAS and added two more PFAS to the Toxic Release Inventory.175 In Feb- ruary 2024, it released two proposed regulations under RCRA, add- ing nine more PFAS to the list of RCRA hazardous constituents.176 Most recently, in April 2024, EPA finalized the designation of two substances—PFOA and PFOS—as hazardous under CERCLA,177 and issued the final PFAS Primary Drinking Water Regulation, which es- tablished legally enforceable levels for six PFAS in drinking water and provides funding to states and territories for testing and treat- ment of public water systems.178 Although each of these encouraging steps would result in less PFAS being discharged into the environment, none specifically ad- dress the widespread uptake of PFAS into food. And direct regula- tion of PFAS in the food supply is markedly lacking. Currently, updated Oct. 31, 2023), https://www.epa.gov/toxics-release-inventory-tri-program/changes- tri-reporting-requirements-and-polyfluoroalkyl [https://perma.cc/B78Q-TGPL]. 172. Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances, 40 C.F.R. § 705 (2023). 173. Advanced Notice of Proposed Rulemaking on Potential Future Designations of Per- and Polyfluoroalkyl Substances (PFAS) as CERCLA Hazardous Substances, U.S. ENV’T. PROT. AGENCY (last updated Oct. 17, 2023), https://www.epa.gov/superfund/advanced-notice-proposed- rulemaking-potential-future-designations-and-polyfluoroalkyl [https://perma.cc/L7PE-5N83]. 174. Proposed PFAS National Primary Drinking Water Regulation, U.S. ENV’T PROT. AGENCY (last updated Mar. 13, 2024), https://www.epa.gov/sdwa/and-polyfluoroalkyl-substances- pfas [https://perma.cc/JW43-BHZV]. 175. Key EPA Actions to Address PFAS, U.S. ENV’T PROT. AGENCY (last updated Feb. 6, 2024), https://www.epa.gov/pfas/key-epa-actions-address-pfas#:~:text=In%20January%202024%2 C%20the%20EPA%20finalized%20a%20rule%20that%20prevents,EPA%20review%20and% 20risk%20determination [https://perma.cc/KY8S-W6J9]. 176. Id. 177. Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, U.S. ENV’T PROT. AGENCY (last updated April 17, 2024), https://www.epa.gov/system/files/documents/2024-04/pre-publication_final-rule-cercla- pfoa-pfos-haz-sub.pdf. 178. PFAS National Primary Drinking Water Regulation Rulemaking, U.S. ENV’T PROT. AGENCY (last updated April 8, 2024), https://www.epa.gov/system/files/documents/2024-04/pfas- npdwr_prepubfederalregisternotice_4.8.24.pdf. 320 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 USDA’s involvement with PFAS is limited to (1) its “Screening, De- termination, and Confirmation of PFAS” initiative, which establishes testing methods and laboratory procedures for the detection of PFAS in food, (2) its Dairy Indemnity Payment Program, which seeks to support financially farmers whose livestock was contaminated with PFAS,179 and (3) its Euthanization Program, administered by Animal Wildlife Services, which likewise handles livestock that (usually through accidental discovery or private testing and under applicable state levels) has been marked as contaminated and unfit for food consumption.180 No quantitative regulatory levels for PFAS in meat, poultry, or eggs have been set, even though FSIS is statutorily obli- gated to ensure that products under its jurisdiction are “safe and fit for human food.”181 FDA’s actions on PFAS are even more anemic. FDA’s entire en- gagement with PFAS has come through its Total Diet Study, pursuant to which the agency has tested at random less than 800 samples of food collected over four years.182 Based on the results of these tests, a number of which have come back positive,183 FDA’s general stance is that PFAS have been detected in very few samples and at low lev- els and therefore do not merit any regulatory attention.184 This con- clusion starkly contrasts with private and state testing, which has 179. Maeve Sheehey, Cow-Harming ‘Forever Chemicals’ Strain USDA’s Relief Resources, BLOOMBERG L. (Oct. 25, 2022), https://news.bloomberglaw.com/environment-and-energy/cow -harming-forever-chemicals-strain-usdas-relief-resources [on file with the Journal]. 180. U.S. DEP’T AGRIC., FOOD SAFETY & INSPECTION SERV., CLG-PFAS2.04: SCREENING, DETERMINATION, AND CONFIRMATION OF PFAS BY UHPLC-MS-MS (2023). 181. Id. 182. Per- and Polyfluoroalkyl Substances (PFAS), U.S. FOOD & DRUG ADMIN. (last updated Apr. 18, 2024), https://www.fda.gov/food/environmental-contaminants-food/and-polyfluoroalkyl -substances-pfas#:~:text=Tested%20nearly%20800%20samples%20of%20foods%20on%20 the,raised%2C%20or%20processed%20in%20known%20areas%20of%20contamination [on file with the Journal]. 183. FDA Tests Confirm Suspicions about PFAS Chemicals in Food, ENV’T. WORKING GRP. (June 3, 2019), https://www.ewg.org/news-insights/news/fda-tests-confirm-suspicions-about-pfas- chemicals-food [https://perma.cc/N2CU-8QHD] (“The FDA detected PFOS in approximately half of the meat and seafood products; PFPeA in chocolate milk and high levels in chocolate cake with icing; PFBA in pineapple; and PFHxS in sweet potato.”). 184. Update on FDA’s Continuing Efforts to Understand and Reduce Exposure to PFAS from Foods, U.S. FOOD & DRUG ADMIN. (Feb. 24, 2022), https://www.fda.gov/food/cfsan-constituent- updates/update-fdas-continuing-efforts-understand-and-reduce-exposure-pfas-foods [on file with the Journal] (“While the FDA found detectable levels of PFAS in certain seafood samples in this TDS survey, as in previous ones, the sample sizes are limited, and the results cannot be used to draw definitive conclusions about the levels of PFAS in seafood in the general food supply.”). 2024] Bystanders to a Public Health Crisis 321 determined that PFAS are present in produce, milk, and packaged foods.185 Worse yet, as the agency vested with the sole authority to regulate food additives—including chemicals applied on food contact materi- als—FDA actually permits the use of many PFAS on such materi- als.186 It does so despite copious scientific data that these substances migrate onto food187 and that, as EPA has found, there are no safe doses of exposure.188 Most recently, on February 28, 2024, FDA is- sued a press release that sensationally claimed that PFAS will no longer be present in food contact paper materials and declared “’a win’ for public health.”189 A closer look at the details of this “win,” however reveals that very little has actually changed in legally en- forceable ways.190 First, the action is limited to grease-proof paper only, and not to all food packaging (let alone all food contact materi- als).191 Second, the action is also limited to products containing “cer- tain PFAS,” not all PFAS.192 Third, and most troublingly, like FDA’s prior “bans” on PFOA and PFOS, this one too is a voluntary action by industry.193 In other words, there is nothing stopping grease-proof paper manufacturers from changing their mind about this commit- ment tomorrow and there is no mechanism for FDA to enforce the commitment against them (or against other sellers of such products shipped into the U.S. from China, for example). Despite the celebra- tory announcement, to date, FDA has permitted the use of 83 differ- ent PFAS compounds in food contact materials, has asked industry to voluntarily recall several, and has formally banned or disallowed 185. Perkins, supra note 166; Maine Dairy Farm Coming Out of Toxic Nightmare From 'For- ever Chemicals', NEWS CTR. ME. (Mar. 8, 2023), https://www.newscentermaine.com/article /tech/science/environment/pfas/dairy-farm-coming-out-of-a-toxic-nightmare-from-forever- chemicals-pfas-environment-maine-business-agriculture/97-96c362b4-f9fd-42e8-9591-eeb6 9726c4f4 [https://perma.cc/2WHG-9EDA]; Evidence of PFAS in Organic Pasta Sauces, ENV’T HEALTH NEWS (Apr. 13, 2022), https://www.ehn.org/pfas-pasta-sauce-2657142422.html [https://perma.cc/DXE4-XB8E]. 186. See Cronin, supra note 61, at 123-127. 187. See id. 188. See Proposed PFAS National Primary Drinking Water Regulation, U.S. ENV’T PROT. AGENCY (last updated Mar. 13, 2024), https://www.epa.gov/sdwa/and-polyfluoroalkyl- substances-pfas [https://perma.cc/TUQ8-3HRQ] (Mar. 13, 2024). 189. Industry Actions End Sales of PFAS Used in US Food Packaging, U.S. FOOD & DRUG ADMIN. (Feb. 28, 2024), https://www.fda.gov/news-events/press-announcements/fda-industry- actions-end-sales-pfas-used-us-food-packaging [on file with the Journal]. 190. Id. 191. Id. 192. Id. 193. Id. 322 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 none.194 And there are no indications that FDA plans to take any fur- ther binding or legally enforceable steps on the use of PFAS in food or food-adjacent products anytime soon.195 The other players in the food safety space likewise have not taken any actions that directly affect PFAS contamination of food. The CDC’s activities have been limited to researching the spread of PFAS in the human population;196 the ARS is researching potential reme- diation approaches for agricultural environments;197 the Consumer Product Safety Commission has merely issued public notice request- ing information on PFAS’s potential uses and routes of human expo- sure;198 and the National Marine and Fisheries Service is conducting preliminary research on the spread of PFAS in fish and seafood.199 D. PFAS-Specific Regulatory Challenges On top of the general inefficiencies of the current food safety regu- latory scheme,200 PFAS contamination of food also poses unique challenges. Perhaps the biggest challenge is PFAS’s ecological and 194. See Beyond Paper, Part 2: PFAS Intentionally Used to Make Plastic Food Packaging, ENV’T DEF. FUND (Aug. 2021), https://blogs.edf.org/health/2021/08/12/beyond-paper-part-2- pfas-intentionally-used-to-make-plastic-food-packaging/ [https://perma.cc/A5N8-E6PR]; Mangus Land, et al., What is the Effect of Phasing Out Long-Chain Per- and Polyfluoroalkyl Sub- stances on the Concentrations of Perfluoroalkyl Acids and Their Precursors in the Environment? A Systematic Review Protocol, 7 ENV’T EVIDENCE, 2018, at 1, 1–13. 195. See generally Per- and Polyfluoroalkyl Substances (PFAS), U.S. FOOD & DRUG ADMIN., https://www.fda.gov/food/environmental-contaminants-food/and-polyfluoroalkyl- substances-pfas#:~:text=The%20FDA%20has%20authorized%20certain,%2C%20and%20 water%2Dresistant%20properties [available with journal] (last visited Apr. 19, 2024) (noting that “[t]he FDA has authorized certain PFAS for use in specific food contact applications” on the basis of “rigorous review of scientific data prior to their authorization for market entry” and “information [that] demonstrate[s] that there is a reasonable certainty of no harm under the intended conditions of use”). 196. See Toxicological Profile for Perfluoroalkyls, AGENCY FOR TOXIC SUBSTANCES & DISEASE REGISTRY, https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf [https://perma.cc/G7AA-APBR] (last visited Jan. 3, 2024). 197. Research Project: PFAS Fate and Remediation in Agricultural Systems: Developing Con- servation Assistance for Landowners, Project No. 2020-13000-005-017-I, U.S. DEP’T OF AGRIC.: AGRIC. RSCH. SERV. (last modified Mar. 27, 2024), https://www.ars.usda.gov/research/project /?accnNo=445481 [https://perma.cc/6T3Q-ZSZM]. 198. Per- and Polyfluoroalkyl Substances (PFAS) in Consumer Products, 88 Fed. Reg. 64890 (Sept. 20, 2023) [hereinafter USDA Developing Conservation Assistance]. 199. Ecotoxicity of Perfluorooctane Sulfonate and Fluorine-Free Fire Fighting Foams in Estu- arine Organisms, NAT’L CTRS. FOR COASTAL OCEAN SCI., https://coastalscience.noaa.gov/project /ecotoxicity-of-perfluorooctane-sulfonate-and-fluorine-free-fire-fighting-foams-in-estuarine- organisms/ [https://perma.cc/YA74-WQAT] (last visited Apr. 18, 2024). 200. See supra Part III(B). 2024] Bystanders to a Public Health Crisis 323 commercial ubiquity. Because these substances are present virtually everywhere in our environment,201 ascertaining the likely route of food product contamination is challenging.202 This, in turn, poses challenges in determining which agency’s jurisdiction is implicated and what actions may be most appropriate to remedy the situation. PFAS’s entrenched use in almost every industry—from national se- curity operations to firefighting foam and toilet paper203—also threatens daunting industry pushback against any effort to curtail these chemicals’ use. As such, PFAS is a prime example of bystander apathy and the regulatory commons problem.204 Because the prob- lem is too vast and because no regulator has primary responsibility over PFAS in food, inaction, complacency, or bureaucratic paralysis are much likelier outcomes than risky, politically unrewarding, and resource-intensive action in a field of shared and diffused responsi- bility.205 Nor is it easy to scientifically capture the full scope of the problem. PFAS represent a vast—and growing—class of chemicals with any- where from 3000 to 15,000 possible chemical variations.206 A single change in the molecular structure results in a new, and as of yet un- known, chemical that can easily avoid detection.207 This is particu- larly true given that most labs are currently equipped to test for only two substances—PFOS and PFOA—and the most cutting-edge labs sponsored by USDA and FDA usually only test for 16 to 30 substanc- 201. See Glüge et al., supra note 150. 202. See PFAS Strategic Roadmap: EPA's Commitments to Action 2021-2024, U.S. ENV’T PROT. AGENCY (last updated Dec. 14, 2023), https://www.epa.gov/pfas/pfas-strategic-roadmap-epas- commitments-action-2021-2024 [https://perma.cc/758Y-9LFA] (noting that “EPA cannot solve the problem of “forever chemicals” by tackling one route of exposure or one use at a time.”). 203. See Glüge et al., supra note 150; Katherine E. Boronow et al., Serum concentrations of PFASs and exposure-related behaviors in African American and non-Hispanic white women, 29 J. OF EXPOSURE SCI. & ENV’T EPIDEM. 206 (2019); Jake T. Thompson et al., Per- and Polyfluoroalkyl Substances in Toilet Paper and the Impact on Wastewater Systems, 10 ENV’T. SCI. TECH. LETTERS 234 (2023); Kevin Loria, Dangerous PFAS Chemicals Are in your Food Packaging, CONSUMER REPS. (Mar. 24, 2022), https://www.consumerreports.org/health/food-contaminants/ dangerous-pfas-chemicals-are-in-your-food-packaging-a3786252074/ [https://perma.cc/PZS8-AU37]. 204. See supra Part II(C). 205. Id. 206. See CompTox Chemicals Dashboard, Navigation Panel to PFAS Structure List, U.S. ENV’T PROT. AGENCY (Aug. 2022), https://comptox.epa.gov/dashboard/chemical-lists/PFASSTRUCT (listing 14,735 chemicals as satisfying the definition of PFAS). 207. See Zhanyun Wang et al., Fluorinated Alternatives to Long-Chain Perfluoroalkyl Carbox- ylic Acids (PFCAs), Perfluoroalkane Sulfonic Acids (PFSAs) and Their Potential Precursors, 60 ENV’T INT’L 242, 243 (2013). 324 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 es.208 Add to that the fact that labs cannot test for concentrations lower than 4 parts per trillion209 (even though EPA has stated that concentrations lower than that can be harmful to human health), and a grim picture quickly emerges: labs routinely report “not detected” for samples that contain one or more PFAS in not insignificant quan- tities, either because they tested for only a few substances or the concentration of each individual substance fell slightly below the limit of detection (though the total concentration of PFAS may still be staggering).210 Further complicating matters are the different PFAS “safe” limits that each agency has proposed in its advisory opinions. While EPA has opined that there are no safe levels of PFAS and has proposed setting the maximum contaminant level goals for PFAS at 4 ppt due to lab detection capabilities, FDA’s limit is current- ly at 50 ppt,211 and USDA’s is at 500 ppt.212 Therefore, even assum- ing that a lab is equipped to properly conduct a test for all PFAS that may be present in a product, the lab result may be interpreted as “not detected,” “below method detection limit,” or at a level of con- cern depending on the agency that ordered the test. These scientific difficulties of capturing the extent of the PFAS threat also highlight the misguided approach of seeking to regulate individual PFAS substances rather than PFAS as a class. Regulators have long rejected this approach in the context of heavy metals, for example, where FDA took into account “all the metals across all foods rather than one contaminant, one food at a time” because “[e]ven though the levels of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.”213 Aside from cumulative exposure, regu- lating individual PFAS presupposes that each agency has to wait for 208. See Susan Genualdi et al., Analyte and matrix method extension of per- and polyfluoro- alkyl substances in food and feed, 416 ANALYTICAL & BIOANALYTICAL CHEM. 627, 627-628 (2024). 209. Linda Cook & Kirk O’Reilly, Regulating PFAS at the Edge of Detection, ABA J. (June 21, 2023), https://www.americanbar.org/groups/environment_energy_resources/publications /wqw/regulating-pfas-at-edge-of-detection/ [on file with the Journal]. 210. See Wang et al., supra note 207. 211. U.S. FOOD & DRUG ADMIN., C-010.3, FDA FOODS PROGRAM COMPENDIUM OF ANALYTICAL LABORATORY METHODS: CHEMICAL ANALYTICAL MANUAL (CAM) 15 (Dec. 19, 2021) (setting the low- est reference standard at 0.05 ng/g, which is equivalent to 50 ppt). 212. U. S. DEP’T OF AGRIC., CLG-PFAS 2.03, SCREENING, DETERMINATION AND CONFIRMATION OF PFAS BY UPLC-MS-MS 10 (2021) (setting the lowest reference standard at 0.5 ng/g, which is equivalent to 500 ppt). 213. What FDA is Doing to Protect Consumers from Toxic Metals in Foods, U.S. FOOD & DRUG ADMIN. (Apr. 20, 2018), https://www.fda.gov/food/conversations-experts-food-topics/what- fda-doing-protect-consumers-toxic-metals-foods [https://perma.cc/ZHW5-9Y42]. 2024] Bystanders to a Public Health Crisis 325 definitive scientific studies on the negative health effects of particu- lar individual substances. But, if a substance was only created in a lab yesterday, that means that it would be years before any scientific data can emerge on its individual operation.214 Meanwhile, it would be put into the stream of commerce unimpeded, and consumers would continue to get sicker while they wait for regulatory certain- ty.215 Such a substance-by-substance approach makes no sense in the face of strong scientific confidence that the entire class behaves similarly and poses equally devastating health risks. The only logical and effective regulatory approach is dealing with PFAS as a class,216 but the enormity of that task leads right back to bureaucratic paraly- sis and the bystander effect. The totality of these obstacles has so far prevented effective—or any—regulation of PFAS in food, leaving consumers exposed to dan- gerous chemicals with their every meal. Any proposed solution to this crisis must therefore take these difficulties into account and find a way to overcome them. IV. IN SEARCH OF A SOLUTION TO THE CRISIS OF PFAS IN FOOD “Progress, far from consisting in change, depends on retentiveness. […] Those who cannot remember the past are condemned to repeat it.” George Santayana217 The overall state of dysfunction of the food safety system has long been a subject of academic interest and many proposed fixes have been put forth over the years. The problem of PFAS in food, by con- trast, is a recent, underpublicized, and underexamined issue, for which no currently viable solutions exist. In search of a feasible re- sponse to this public health crisis, this section first reviews (and re- jects) the most commonly proposed fix to the broader regulatory fragmentation and dysfunction. It then looks to PFAS-specific long- term solutions, before zeroing in on a more practical, realistic, and readily applicable approach. 214. Nicholas “Hoo” Ray, Emerging Trends in PFAS Litigation, 52 TEX. ENVT’L. L.J. 73, 76 (2023). 215. Id. 216. Id. at 78. 217. GEORGE SANTAYANA, THE LIFE OF REASON: INTRODUCTION AND REASON IN COMMON SENSE 172 (Marianne Wokeck & Martin A. Coleman eds., 2011). 326 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 A. A Centralized Food Safety System One of the most cited solutions to any food safety crisis—including those precipitated by foodborne illnesses and environmental con- taminants—is complete reformation of the current regulatory sys- tem to a unified, single-agency paradigm. Such a centralized system, the premise states, would be better equipped to address all threats to food safety (including, by implication, PFAS) by avoiding duplica- tive, inconsistent, or under-regulation. As early as 1949, a commis- sion chaired by former President Herbert Hoover showed significant concern over, among other things, the lack of proper regulation of chemicals and contaminants, and recommended consolidating all food safety regulation under a single agency (USDA).218 In 1977, the Senate Government Affairs Committee undertook a two-year inves- tigation into the state of food and food safety regulation and likewise recommended consolidating all food safety functions into a single agency (FDA).219 In 1993, the Clinton Administration stated its sup- port for folding in the functions of FSIS into FDA.220 And in 1998, a Committee to Ensure Safe Food from Production to Consumption conducted a thorough review of the shortcomings of a fragmented food safety system and concluded that “Congress should establish, by statute, a unified and central framework for managing federal food safety programs, one that is headed by a single official and which has the responsibility and control of resources for all federal food safety activities, including outbreak management, standard-setting, inspec- tion, monitoring, surveillance, risk assessment, enforcement, re- search, and education.”221 This report did not opine on where exact- ly such authority should be located.222 Many others in recent years have likewise noted that Congress should replace the existing food safety law with a “unified law covering the entire food supply,” that encompasses the functions of FSIS, FDA, and EPA’s pesticide pro- gram.223 In total, the Government Accountability Office has issued 218. HOOVER COMMISSION REPORT, supra note 35, at 251. 219. CASE STUDY OF USDA AND FDA , supra note 12, at 138–43. 220. ALBERT GORE, FROM RED TAPE TO RESULTS: CREATING A GOVERNMENT THAT WORKS BETTER & COSTS LESS 101 (1993). 221. INST. OF MED. & NAT’L RSCH. COUNCIL, ENSURING SAFE FOOD FROM PRODUCTION TO CONSUMPTION 97 (1998). 222. See id. 223. See, e.g., Michael R. Taylor, Reforming Food Safety: A Model for the Future, RES. FOR THE FUTURE 9 (2002), https://media.rff.org/documents/RFF-IB-02-02.pdf [https://perma.cc/U4TD https://media.rff.org/documents/RFF-IB-02-02.pdf 2024] Bystanders to a Public Health Crisis 327 sixteen reports documenting the dysfunction of the current food safety system and calling for the creation of a single agency, its most recent report dating back to 2021.224 And the last three presidents have all criticized the fragmented food safety system and have called for either coordination or consolidation of regulatory functions.225 Although a unified food safety system housed in a single agency has extremely high theoretical appeal, it universally lacks practical support. Even the most ardent proponents of a single-agency regula- tory scheme admit the extreme difficulty involved in putting Humpty Dumpty back together again. Richard Merrill—one of the drafters of the 1998 Committee report that recommended a unified system— has explained in detail the insurmountable logistical hurdles inher- ent in such a proposal.226 These include severing existing synergies and agency ties between food safety programs and other food regu- lation, attempting to mesh together personnel from different divi- sions and with different functions, allocating resources between the various programs, inevitably leaving programs behind or with no home, determining the agency leadership status and the bureaucrat- ic location of the new agency (centralized like FDA or heavily field- present like FSIS), and many others.227 Beyond these open ques- tions, there is the resounding lack of political will that has plagued Washington in recent years and that has left many a worthy bill to die. Congress has held more than twenty hearings on potential re- forms to the food safety system and at least ten bills have been in- troduced to create a single agency.228 None of these bills has seen the light of day past its first reading.229 Even unimaginable tragedies involving children fatally poisoned by contaminated food have not been sufficient to move this issue forward and to garner sufficient -74CM] (noting that if creating an entirely new agency is not an option, the food safety func- tions should be consolidated within HHS). 224. Bernice Yeung et al., The Low-And-Slow Approach to Food Safety Reform Keeps Going Up in Smoke, PROPUBLICA (Dec. 23, 2021), https://www.propublica.org/article/the-low-and- slow-approach-to-food-safety-reform-keeps-going-up-in-smoke [https://perma.cc/A3VM- XKP3]; See also U.S. GOV’T ACCOUNTABILITY OFF., HIGH-RISK SERIES: DEDICATED LEADERSHIP NEEDED TO ADDRESS LIMITED PROGRESS IN MOST HIGH-RISK AREAS (2021). 225. Yeung et al., supra note 220. 226. Merrill & Francer, supra note 13, at 82. 227. Id. See also ALEJANDRO CAMACHO & ROBERT GLICKSMAN, REORGANIZING GOVERNMENT, 58–64 (2019) (cataloguing the failure of scholars to account for function in assessing and proposing structural reform to the federal food system). 228. Camacho & Glicksman, supra note 223, 58–64. 229. See, e.g., Safe Food Act of 2019, S. 1995, 116th Cong. (2020) (introduced to Senate with no further action taken). 328 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 legislative support.230 Whatever the merits of a unified approach to food safety may be, the dire reality is that PFAS contamination of our food supply is both an entrenched and pressing need that must be addressed now, not in a hypothetical (and practically unrealistic) fu- ture. B. Banning PFAS in Food Products A smaller scale—and thus presumably more feasible—solution is to replicate prior examples of environmental contaminant regula- tion. In the past, an Act of Congress directly banned the use of specif- ic environmental contaminants and augmented EPA’s authority to set limits and tolerances that USDA and FDA could then monitor and enforce.231 A similar scheme, where EPA would enforce a total ban on PFAS’s use, while FDA and USDA would test for the presence of PFAS residue in food and recall adulterated products, would be an effective way to regulate PFAS in food. Over the past few years, several proposed Acts to ban the use of PFAS have been introduced in Congress. In 2021, Rep. Debbie Dingell introduced a bill to designate PFOS and PFOA as “persistent, bioaccumulative, and toxic substances,” and as hazardous under CERCLA and the CAA.232 HR 117-2467, which passed in the House in 2021 but stalled in the Senate, also proposed further investigation into GenX contamination and empowering EPA to designate all PFAS as hazardous under CERCLA and as toxic under TSCA.233 Three addi- tional bills were introduced in 2021, mostly requiring EPA to de- mand additional reporting or provide information on PFAS.234 In 2022, a bill sought to require EPA to ask for analytical reference standards from PFAS manufacturers.235 None of these bills advanced past a first reading on the floor. Signaling the exponential increase in public awareness and con- cern over PFAS, legislators introduced more than 50 PFAS-related 230. Id. 231. See Part. II(D) supra. 232. See PFAS Action Act of 2021, H.R. 2467, 117th Cong. (2021). 233. Id. 234. See H.R.4224, 117th Cong. (2021); H.R.4381,117th Cong. (2021); H.R.4567, 117th Cong. (2021). 235. PFAS Reference Standards Act, H.R.7897, 117th Cong.( 2022). 2024] Bystanders to a Public Health Crisis 329 bills in 2023.236 Only three made it out of Committee and only two of these have so far been enacted, and both favor industry, not con- sumers.237 In addition to the general political gridlock in Congress, the proposed bills also faced significant industry opposition. Lobby- ing efforts by DuPont—one of the leading manufacturers of PFAS— totaled $2.5 million for the session that included the one of the more comprehensive bills meant to address PFAS, while the American Chemistry Council, which represents chemical companies, spent a total of $17 million to lobby Congress for that same period.238 With the exception of the No Toxins in Food Packaging Act of 2023, which sought to prohibit the use of PFAS in food packaging and failed in Congress, none of the proposed laws addressed food safety in any way.239 Even if one of these proposals, or a hypothetical future bill, were to break away from the pack and make it through the morass of industry lobbying and the political impasse, substantial immediate regulation of PFAS in food is not likely to come through this route in the foreseeable future. C. Relying on FDA and USDA Authority Considering the near impossibility of passing new legislation to address PFAS in food, the only feasible solution must come from ex- isting regulatory authority. Under the analytical framework of by- stander apathy, the first step in forcing action on a pressing, com- plex, and diffuse issue like the spread of PFAS in food is to select an agency responsible for its implementation. Bystander no more, that agency is thus freed from bureaucratic paralysis and entrusted with using the full might of its regulatory power to resolve the issue that it now has a vested interested in. Due to its primacy in the food space and its significant regulatory authority over food safety, at first blush, FDA would be the obvious candidate to take the lead on this issue. Indeed, under its existing authority, FDA could do a lot to address the spread of PFAS in the 236. See Congress.Gov search results for “PFAS,” https://www.congress.gov/search?q=%7 B%22source%22%3A%22legislation%22%2C%22search%22%3A%22PFAS%22%7D (last visited Apr. 19, 2024). 237. See Tom Perkins, Bills to Regulate Toxic ‘Forever Chemicals’ Died in Congress – with Re- publican Help, GUARDIAN (Jan. 13, 2023, 5:00 AM), https://www.theguardian.com/environment /2023/jan/13/pfas-toxic-forever-chemicals-republican-house [https://perma.cc/3CHN- TADC]. 238. Id. 239. No Toxics in Food Packaging Act of 2023, H.R. 6105, 118th Cong. (2023). 330 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 food supply. For one, the FDCA charges FDA with regulating adul- teration of crops because of “sewage, chemicals, heavy metals, path- ogenic microorganisms, or other contaminants,”240—a lineup to which PFAS readily belongs. Thus, FDA has the authority to remove from the market any domestic or imported products that it considers unfit for human consumption due to the presence of such contami- nants.241 FDA also has exclusive authority over food additives in both food itself and in food contact materials.242 It could therefore revoke any prior authorizations for the use of PFAS in paper, packag- ing, food processing equipment, or any other food-adjacent medi- um.243 FDA could also require labeling of food products with inten- tionally added PFAS or may set maximum allowable levels for PFAS, thus requiring manufacturer testing and self-reporting of products that contain PFAS as a byproduct of environmental contamination.244 Lastly, the agency could systematically monitor the spread of PFAS in the food supply to better understand the types of commodities and environments most at risk for contamination, as it has done for heavy metals in the past.245 Despite this ample authority, FDA has not chosen to act on PFAS to date in any meaningful way. This is primarily due to FDA’s skepti- cism over the scope of the problem. Relying on its limited testing, FDA currently finds “no indication that the PFAS at the levels found in the limited sampling of foods collected for the TDS present a hu- man health concern.”246 With respect to food contact materials, de- spite recently declaring the phasing out of certain PFAS-laden food contact materials to be “’a win’ for public health,”247 FDA continues to maintain that, for most products, there is only “a negligible 240. 21 U.S.C. § 342(a)(4). 241. Id. at § 334. 242. Id. at § 348(h). 243. See Cronin, supra note 61. 244. 21 U.S.C. 343(a)(1). Cf. 21 C.F.R. § 165.110 (2013) (setting labeling and testing re- quirements for contaminants in bottled water). 245. See, e.g., U.S. FOOD & DRUG ADMIN, ANALYTICAL RESULTS FOR ARSENIC IN FOOD INTENDED FOR BABIES AND YOUNG CHILDREN SAMPLED UNDER THE FDA’S TOXIC ELEMENTS IN FOOD AND FOODWARE, AND RADIONUCLIDES IN FOOD – IMPORT AND DOMESTIC COMPLIANCE PROGRAM (FY2009-FY2021) (n.d.), https://www.fda.gov/media/164564/download?attachment. 246. Analytical Results of Testing Food for PFAS from Environmental Contamination, U.S. FOOD & DRUG ADMIN. (last updated Apr. 18, 2024), https://www.fda.gov/food/process- contaminants-food/analytical-results-testing-food-pfas-environmental-contamination [on file with the Journal]. 247. See supra, Part III. 2024] Bystanders to a Public Health Crisis 331 amount of PFAS capable of migrating to food.”248 Therefore, despite petitions from consumer advocate groups to ban the use of PFAS in food contact materials, FDA has refused to do so.249 FDA makes room for the possibility that its “conclusions related to the potential human health concerns for certain levels of PFAS found in food may change.”250 It readily admits that its testing to date is “limited,” and that it therefore cannot “draw definitive conclu- sions.”251 Indeed, in its 2024 budget, FDA has asked for an additional $5 million to allow CFSAN to study PFAS further.252 It has also asked for an additional $23 million for the “Healthy and Safe Food for All” initiative, which includes increased funding for field inspectors and for developing better testing methods for emerging contaminants, including PFAS.253 FDA’s recently issued draft guidance to industry on safe food also included PFAS as a potential contaminant.254 Beyond food, FDA is also actively researching PFAS as part of its new obligations under the Modernization of Cosmetics Regulation Act.255 Importantly, the agency also recently finalized its proposal for creating a Unified Human Food Program, which seeks to remedy many of the structural inefficiencies and organizational handicaps that have plagued FDA’s food arm for years.256 All of these factors 248. Authorized Uses of PFAS in Food Contact Applications, U.S. FOOD & DRUG ADMIN. (May 31, 2023), https://www.fda.gov/food/process-contaminants-food/authorized-uses-pfas-food- contact-applications [on file with the Journal]. 249. See, e.g., Env’t Def. Fund et al., Citizens Petition Requesting That the Agency Take More Aggressive Action to Protect Consumers From Per- and Poly-fluoroalkyl Substances (PFAS) by Banning All Forms that Biopersist in the Human Body (June 3, 2021), https://static.ewg.org/reports/2022/pfas-fda-timeline/June-03-2021.pdf [https://perma.cc/CYK7-SSG6]. 250. Testing Food for PFAS and Assessing Dietary Exposure, U.S. FOOD & DRUG ADMIN. (Aug. 28, 2023), https://www.fda.gov/food/process-contaminants-food/testing-food-pfas-and- assessing-dietary-exposure [on file with the Journal]. 251. Id. 252. U.S. DEP’T OF HEALTH & HUM. SERVS., FISCAL YEAR 2024, JUSTIFICATION OF ESTIMATES FOR APPROPRIATIONS COMMITTES 52 (2023) https://www.fda.gov/media/166182/download [https://perma.cc/B8ZC-FRCH]. 253. Id. 254. U.S. FOOD & DRUG ADMIN., HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD: GUIDANCE FOR INDUSTRY, 20 (Jan. 2024), https://www.fda.gov/media/100002 /download?attachment [https://perma.cc/TN5Q-RCM7]. 255. Modernization of Cosmetics Regulation Act of 2022, Pub. L. No. 117-328, 136 Stat. 5847 (enacting 21 U.S.C.A. §§ 364 to 364j, amending 21 U.S.C.A. §§ 331, 361, 362, 374, and 381, and enacting provisions set out as notes under 21 U.S.C. §§ 331, 364, 364d, and 364e). 256. FDA’s Proposal for a Unified Human Foods Program and New Model for the Office of Regulatory Affairs, U.S. FOOD & DRUG ADMIN. (last updated Dec. 13, 2023), https://www.fda.gov/about-fda/fda-organization/fdas-proposal-unified-human-foods- 332 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 may collide to produce a change in FDA’s tack on PFAS and may eventually result in meaningful regulation of these toxins in food products by the food agency. However, much like a legislative ban on PFAS, FDA action on this issue is so far only hypothetical, current- ly counterfactual, and at best too distant. The same can be said about USDA. FSIS has authority to inspect meat, poultry, and eggs for the presence of any contaminants under its National Residue Program and to order a recall of adulterated products.257 Indeed, using this authority, USDA has previously sam- pled animal products for the presence of PFAS, but its efforts have been extremely limited and unsystematic. Despite conducting daily inspections of all meat processing plants in the country for other hazards, FSIS has only sampled a total of 3156 cattle, poultry, and egg products in the span of two years (2021-2022).258 FSIS also has authority to require product manufacturers to include toxic contam- inants, such as PFAS, in their hazard analysis and risk assessment plans under HACCP,259 but it has not shown any interest in doing so to date. USDA’s ARS is currently conducting several research pro- jects focused on learning more about PFAS in agriculture—including remediating agricultural systems,260 improving farming practices to reduce PFAS,261 and studying PFAS in soil, sediment, and water.262 Much like FDA, FSIS may therefore change its approach to PFAS in the products under its jurisdiction as more information becomes program-and-new-model-office-regulatory-affairs [https://perma.cc/V648-AC66]. See also Part II(B) supra. 257. FSIS Directive 8410.1, Revision 6, Detention and Seizure (U.S.D.A. 2014). 258. See also CLG-PFAS2.04 Screening, Determination, and Confirmation of PFAS by UHPLC-MS-MS, USDA, FSIS (Feb. 28, 2023), https://www.fsis.usda.gov/sites/default/files /media_file/documents/CLG-PFAS2.04.pdf. 259. U.S. DEP’T OF AGRIC., FOOD SAFETY & INSPECTION SERV. CLG-PFAS2.04, SCREENING, DETERMINATION, AND CONFIRMATION OF PFAS BY UHPLC-MS-MS (Feb. 28, 2023); 9 C.F.R. § 417.2 (2018). See also, U.S. DEP’T OF AGRIC., FOOD SAFETY & INSPECTION SERV. GUIDEBOOK FOR THE PREPARATION OF HACCP PLANS, 5 (2021) (noting that one goal of HACCP is to “prevent, or to re- duce to an acceptable level, contamination with other biological, chemical, and physical haz- ards”). 260. USDA Developing Conservation Assistance, supra note 197. 261. Research Project: Identifying Effective Farming Practices to Reduce Risks of Per- and Polyfluoroalkyl Substances (PFAS) in Food Crop Productions, Project No. 2020-13000-005-007- R, U.S. DEP’T OF AGRIC., AGRIC. RSCH. SERV. (last modified Apr. 18, 2024), https://www.ars.usda.gov/research/project/?accnNo=438976 [https://perma.cc/R75P- QGFX]. 262. Research Project: Multi-site Study of Soil, Sediments and Water for PFASs Analysis in North Carolina, Project No. 2020-13000-005-013-S (2023-2025), U.S. DEP’T OF AGRIC., AGRIC. RSCH. SERV., https://www.ars.usda.gov/research/project?accnNo=444359 [https://perma.cc /2PJH-BTXT]. 2024] Bystanders to a Public Health Crisis 333 available from these planned research efforts. Hoping for such ac- tion, however, is too speculative to provide a reliable and current pathway for change. D. Breaking Free from Bystander Apathy: Empowering EPA to Act Although USDA and FDA have so far shown indifference to PFAS in food, EPA has been highly active in the last few years in its attempts to address the broader PFAS crisis. Capitalizing on the Biden Admin- istration’s stated interest in combatting PFAS contamination,263 EPA issued its “PFAS Roadmap” in 2021 and has steadily been working towards remediating and reducing PFAS through multiple avenues under its existing regulatory authority.264 Where other agencies are still in the early stages of researching these substances and refining their testing methods, EPA has amassed a significant knowledge bank on the spread, chemical profile, health effects, and environmen- tal behavior of these chemicals.265 This record of action makes it best suited to handle PFAS’ scientific complexity and ubiquitous spread on an accelerated timeline. EPA has also taken significant steps under its existing authority to regulate PFAS by using provisions of the TSCA, SDWA, CWA, RCRA, CERCLA, and the Emergency Planning and Community Right-to- Know Act.266 While more could be done,267 this willingness to act even in the face of fierce opposition by the chemical industry shows a pattern of behavior more consistent with a leadership paradigm than a bystander. It also makes EPA best positioned to take on the issue of PFAS in food so long as it has an available jurisdictional hook to act. 263. See, e.g., Press Release, White House, Fact Sheet: Biden-⁠Harris Administration Launch- es Plan to Combat PFAS Pollution, (Oct. 18, 2021), https://www.whitehouse.gov/briefing- room/statements-releases/2021/10/18/fact-sheet-biden-harris-administration-launches- plan-to-combat-pfas-pollution/ [https://perma.cc/8UGA-65JC]; Press Release, White House, Fact Sheet: Biden-⁠Harris Administration Combatting PFAS Pollution to Safeguard Clean Drink- ing Water for All Americans, (June 15, 2022), https://www.whitehouse.gov/briefing- room/statements-releases/2022/06/15/fact-sheet-biden-harris-administration-combatting- pfas-pollution-to-safeguard-clean-drinking-water-for-all-americans/ [https://perma.cc/CUV9- P6NW]. 264. See Part II(C) supra. 265. See Per- and Polyfluoroalkyl Substances (PFAS), U.S. ENV’T PROT. AGENCY (last updated Feb. 8, 2024) https://www.epa.gov/pfas [https://perma.cc/MCC7-ZLMU]. 266. See Part III(C) supra. 267. See Nevitt & Percival, supra note 44. See also Robert L. Glicksman & Johanna Adashek, Delegated Agency Authority to Address Chemicals of Emerging Concern: EPA’s Strategic Use of Emergency Powers to Address PFAS Air Pollution, 48 HARV. ENV’T L. REV. (forthcoming 2024). 334 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 And, as it turns out, it does. Through its authority to regulate pesti- cides under FIFRA, FDCA, and FQPA—a route that so far has re- mained unexplored in the scholarship—EPA has at its disposal a regulatory mechanism that could allow it to directly reach food without the need for further Congressional action or a sweeping ad- ministrative reform.268 The parallels between pesticide use in the 1970s, when EPA was created, and use of PFAS today are astonishing. In 1964, Rachel Car- son wrote in Silent Spring about the countless chemicals “sold under several thousand different brand names” which were “applied al- most universally to farms, gardens, forests, and homes” and have “the power to kill every insect, the ‘good’ and the ‘bad,’ to still the song of birds and the leaping of fish in the streams, to coat the leaves with a deadly film, and to linger on in soil.”269 Little needs to be changed in her words to accurately depict the state of PFAS use, con- tamination, and devastation today. Much like FDA and USDA shared jurisdiction on pesticides and engaged in bystander apathy then, even in the face of dire safety and health warnings, they do so with regards to PFAS today. Beyond poetic parallels, however, EPA’s authority to regulate pes- ticides could be read to encompass PFAS because PFAS are not only like pesticides in many respects, they also are in pesticides. Pesticide products contain both active substances listed on the product label and inert ingredients added to the final product as “emulsifiers, sol- vents, carriers, aerosol propellants, fragrance and dyes.”270 Accord- ing to latest research from the European Union, a significant per- centage of all approved synthetic pesticides on the market in 2023 contain PFAS as either active or inactive ingredients.271 268. See Merrill & Francer, supra note 13, at 106 (noting that EPA’s pesticide residue pro- gram “is the largest single federal unit responsible for evaluating the safety of chemicals added to food” but not analyzing its potential to expand to other toxic contaminants). 269. Carson, supra note 13, at 7. 270. Inert Ingredients Regulation, U.S. ENV’T PROT. AGENCY https://www.epa.gov/pesticide- registration/inert-ingredients-regulation [https://perma.cc/9R4R-URST] (last visited Jan. 1, 2024). 271. New EU Report Examines PFAS in Pesticides, WASTE 360 (Nov. 15, 2023), https://www.waste360.com/pfas-pfoas/new-eu-report-examines-pfas-pesticides [https://perma.cc/76WM-FH4Z]. See also Linda G.T. Gaines, Historical and current usage of per-and polyfluoroalkylsubstances (PFAS): A literature review, 66 AM. J. OF INDUS. MED. 349, 365– 66 (discussing the many uses of PFAS, including in pesticide formulations as both active and inert ingredients). 2024] Bystanders to a Public Health Crisis 335 Under some definitions for PFAS, a number of active pesticide in- gredients currently approved for use are PFAS themselves.272 Ac- cording to the Minnesota Department of Agriculture, for example, “[o]ver 90 active ingredients were identified as meeting the SF 1955 definition of PFAS.”273 Maine likewise found 55 PFAS compounds used as active ingredients in over 1,400 pesticide formulations.274 That is far from a localized or one-off problem either. Scientists in Portugal found that nearly 70% of the pesticides introduced from 2015 to 2020 used fluorinated chemicals—many of which fit the def- inition of PFAS.275 Similarly, research in the UK found that, of the fif- ty most widely used pesticide substances for arable crops, fourteen were fluorinated and fit the definition of PFAS.276 Nineteen more fluorinated pesticides were used on amenities (lawns, golf courses, highways, etc.) in 2021 alone.277 In addition, because of PFAS’ water-, oil-, and degradation- resistant properties, these chemicals are often added to pesticide formulations as surfactants and penetrating agents. They are thus classified as inert ingredients that do not need to be explicitly listed on the product label. Some environmental toxicology studies have found various PFAS substances in pesticide formulations at levels of 4–19 million parts per trillion (which, even if diluted per label use, would still be hundreds of thousands of times higher than current EPA health advisories for PFAS in water).278 States have likewise found PFAS in pesticides and insecticides they routinely apply to public land despite the lack of these substances on the ingredient la- 272. Lisa Held, New Evidence Shows Pesticides Contain PFAS, and the Scale of Contamination is Unknown, CIVIL EATS (Nov. 7, 2022), https://civileats.com/2022/11/07/pfas-forever- chemicals-pesticides-pollution-farmland-mosquito-control-epa-inert-ingredients/ [https://perma.cc/K78J-MLCP](“dozens of pesticides registered in the U.S. inherently qualify as PFAS themselves, based on their molecular structure”). 273. Trisha Leaf, Active and Inert PFAS, MINN. DEP’T. OF AGRIC. (last updated Jan. 2024), https://www.mda.state.mn.us/environment-sustainability/active-inert-pfas [https://perma.cc/MYB5-HTRX] 274. Monica Amarelo, Maine data unveils troubling trend: 55 PFAS-related chemicals in over 1,400 pesticides, ENV’T WORKING GRP. (June 6, 2023) https://www.ewg.org/news- insights/news-release/2023/06/maine-data-unveils-troubling-trend-55-pfas-related- chemicals [https://perma.cc/JU29-D6T8]. 275. Id. (discussing Diogo A.M. Alexandrino et al., Revisiting Pesticide Pollution: The Case of Fluorinated Pesticides, 292 Env’t Pollution (Part A 2022)). 276. The Problem with PFAS in Pesticides, PFAS FREE, (Mar. 22, 2023), https://www.pfasfree.org.uk/uncategorised/pfas_in_pesticides [https://perma.cc/8HZU- TC2Q]. 277. Id. 278. Held, supra note 272. 336 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 bels. Massachusetts found high concentrations of several PFAS sub- stances in the pesticide Anvil 10+10,279 Maryland found 3,500 ppts of PFOA and 630 ppt of the newer generation Gen-X in the widely used mosquito insecticide Permanone 30-30,280 and the Center for Biological Diversity found PFAS in high concentrations in “three of seven agricultural pesticides [it] tested” in California.281 The full extent of PFAS use and concentration in pesticides or the rate of transfer to humans from that specific source is difficult to as- certain, given the lack of labeling for inert ingredients,282 the fact that PFAS can also leach into pesticides from packaging,283 and the many routes of human exposure to PFAS in daily life.284 What is im- portant for present purposes, however, is not quantifying the use of PFAS in pesticides, but more so providing a jurisdictional basis for EPA to regulate PFAS residues in food products. Although data from the U.S. is currently nonexistent, studies from Europe demonstrate that PFAS pesticide residue in food is a pervasive—and growing— problem. Most prominently, an April 2024 pesticide residue study from the UK discovered that “ten different PFAS pesticides were pre- sent in spices and a range of fruit and vegetables including grapes, 279. See Summary Table: PFAS Concentrations from MassDEP Anvil 10 + 10 Sampling Initia- tive, MASS DEP’T OF ENV’T PROT. (Nov. 19, 2020), https://peer.org/wp-content/uploads/2020 /11/Anvil-PFAS-sample-data-summary-table-11-20-20-final.pdf [https://perma.cc/R55L- 4B7S]; see also Kyla Bennett & Kirsten Stade, Aerially Sprayed Pesticide Contains PFAS, PUB. EMP. FOR ENV’T RESP. (Dec. 1, 2020) https://peer.org/aerially-sprayed-pesticide-contains-pfas/ [https://perma.cc/KDB5-Y5LT]. 280. Ruth Berlin, PFAS Found in Widely Used Insecticide, MD. PESTICIDE EDUC. NETWORK (Mar. 26, 2021), https://mdpestnet.org/pfas-found-in-widely-used-insecticide/ [https://perma.cc /MZ2H-K3ZX]. 281. Email from Eurofins Lancaster Laboratories Environment Testing to the California Department of Pesticide Regulation and the California Department of Food and Agriculture Re: Agency Action needed to Address PFAS Contamination in Pesticides (Maay 1, 2023), https://www.biologicaldiversity.org/campaigns/pesticides_reduction/pdfs/PFAS-letter-to- CA.pdf [https://perma.cc/M494-L34M]. 282. Basic Information about Pesticide Ingredients, U.S. ENV'T PROT. AGENCY, https://www.epa.gov/ingredients-used-pesticide-products/basic-information-about-pesticide -ingredients [https://perma.cc/UG8C-KEC8] (July 6, 2023) (“Under federal law, the identity of inert ingredients is confidential business information. The law does not require manufacturers to identify inert ingredients by name or percentage on product labels. In general, only the total percentage of all inert ingredients is required to be on the pesticide product label.”). 283. See Updates on EPA Efforts to Address PFAS in Pesticide Packaging, U.S. ENV'T PROT. AGENCY, https://www.epa.gov/pesticides/updates-epa-efforts-address-pfas-pesticide- packaging [https://perma.cc/7LQ5-KLCF] (June 5, 2023). 284. See Per- and Polyfluoroalkyl Substances (PFAS), U.S. ENV'T PROT. AGENCY (last updated Apr. 10, 2024), https://www.epa.gov/pfas [https://perma.cc/CY43-NCZR] (Feb. 8, 2024). 2024] Bystanders to a Public Health Crisis 337 cherries, spinach, and tomatoes.”285 The same study revealed that a staggering 95% of the 120 samples of strawberries tested contained PFAS pesticide residue.286 Earlier studies from the European Union have likewise demonstrated a sharp increase in the levels of PFAS pesticide residue on fruit and vegetables over ten years—as high as a 3,277% increase in vegetables in Austria, for example.287 The fact that PFAS are used in pesticide formulations coupled with data that they occur in significant quantities as pesticide residue on food products provides strong regulatory basis for EPA to act on this threat in two ways. 1. EPA Could Ban the Use of PFAS in Pesticides Under FIFRA’s licensing scheme for the sale and use of pesticides, “no person in any State may distribute or sell to any person any pes- ticide that is not registered” by EPA.288 EPA can in turn only register a pesticide if it determines that its ingredients do not pose “any un- reasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide. . . .”289 EPA regulations further define a “pesticide chemical” to include “all active and inert ingredients of such pesti- cide.”290 In other words, even though federal law does not require the disclosure of inert ingredient names or concentrations on prod- uct labels, EPA is required by statute to evaluate the safety of all pes- ticide ingredients—active and inert—before it may grant a registra- tion for the product to be sold or used in the United States.291 If EPA has previously granted authorization for certain ingredients or 285. Pesticide Action Network UK, “Forever Chemicals” Found in UK Food (April 9, 2024), https://www.pan-uk.org/pfas-forever-chemicals/. 286. Id. 287. PESTICIDE ACTION NETWORK EUROPE, TOXC HARVEST: THE RISE OF FOREVER PFAS PESTICIDES IN FRUIT AND VEGETABLES IN EUROPE (Feb. 2024), https://www.pan-europe.info/sites/pan- europe.info/files/public/resources/reports/Report_Toxic%20Harvest%20The%20rise%20of %20forever%20PFAS%20pesticides%20in%20fruit%20and%20vegetables%20in%20Europe %2027022024%20%281%29.pdf. 288. 7 U.S.C. § 136a(a). 289. 7 U.S.C. § 136a(b). 290. 40 C.F.R. 180.1(i) (2022); Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 § 201(q)(1)(A). 291. Basic Information about Pesticide Ingredients, U.S. ENV'T PROT. AGENCY (last updated Ju- ly 6, 2023), https://www.epa.gov/ingredients-used-pesticide-products/basic-information- about-pesticide-ingredients [https://perma.cc/UG8C-KEC8] (“All inert ingredients must be approved by EPA before they can be included in a pesticide. We review safety information about each inert ingredient before approval.”). 338 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 products, it may subsequently revoke that authorization and remove certain ingredients from the list of approved substance if new data demonstrates a lack of safety.292 When used as either active or inert ingredients in pesticides, PFAS squarely fall within the definition of pesticide chemical and are sub- ject to EPA regulation for that use. Indeed, EPA has already used its authority under FIFRA to remove PFAS substances from its list of in- ert ingredients previously approved for use in pesticide products.293 After the discovery of PFAS in an insecticide formulation (which ap- pear to have migrated into the liquid after a minute-long contact with the HDPE plastic fluorinated container294), and a highly publi- cized September 2022 study (which found PFOS and other PFAS in 7 out of 10 insecticide formulations used on USDA crop research field295), EPA removed 12 PFAS that were previously approved for use as inert ingredients in pesticides from the list of approved sub- stances.296 As part of that action, EPA also stated that it will “contin- ue[] to evaluate all pesticide active ingredients to determine if any meet the current structural definition of PFAS or are part of other re- lated chemistries that have been identified by stakeholders as being of concern.”297 More than a year later, EPA is now armed with signif- 292. 7 U.S.C. § 136(d); see also Inert Ingredients — Reassessment Decision Documents (last updated May 30, 2023), U.S. ENV'T PROT. AGENCY, https://www.epa.gov/ingredients-used- pesticide-products/inert-ingredients-reassessment-decision-documents [https://perma.cc/JB3G-5TJQ], 293. Pesticides; Removal of PFAS Chemicals From Approved Inert Ingredient List for Pesti- cide Products, 87 Fed. Reg. 76488, 76489 (Dec. 14, 2022). 294. See Updates on EPA Efforts to Address PFAS in Pesticide Packaging, U.S. ENV'T PROT. AGENCY (last updated June 5, 2023), https://www.epa.gov/pesticides/updates-epa-efforts- address-pfas-pesticide-packaging [https://perma.cc/7LQ5-KLCF]. See also Env’l Defense Fund, Beyond Paper: PFAS Linked to Common Plastic Packaging Used for Food, Cosmetics, and Much More¸ https://blogs.edf.org/health/2021/07/07/beyond-paper-pfas/#:~:text=EPA%20rinsed%20eight %20HDPE%20containers,fully%20fluorinated%20carbons%2C%20including%20PFOA (July 7, 2021). 295. Steven Lasee et al., Targeted analysis and Total Oxidizable Precursor assay of several in- secticides for PFAS, J. HAZARDOUS MATERIALS LETTERS, Nov. 2022, at 3. 296. See EPA Stops Use of 12 PFAS in Pesticide Products, U.S. ENV'T PROT. AGENCY, https://www.epa.gov/pesticides/epa-stops-use-12-pfas-pesticide-products [https://perma.cc /RQ8L-MLUX] (May 3, 2023). Alarmed by the findings of the Sept. 2022 study, EPA attempted to repeat the testing and announced that its own lab found no detectable PFAS in the tested samples. See YAORONG QIAN & DAVID FRENCH, U.S. ENV'T PROT. AGENCY, ANALYTICAL CHEMISTRY BRANCH, VERIFICATION ANALYSIS FOR PFAS IN PESTICIDE PRODUCTS (ACB PROJECT B23-05B) 5 (2023), https://www.epa.gov/system/files/documents/2023-05/BEAD%20PFAS%20Study%20 Results%202023.pdf [https://perma.cc/9YZV-C752]. 297. See EPA Stops Use of 12 PFAS in Pesticide Products, U.S. ENV'T PROT. AGENCY (last updat- ed May 3, 2023), https://www.epa.gov/pesticides/epa-stops-use-12-pfas-pesticide-products [https://perma.cc/RQ8L-MLUX]. 2024] Bystanders to a Public Health Crisis 339 icantly more information on the detrimental environmental and health effects of all PFAS and is in a better position to take further ac- tion under this authority. Following its previous tack, EPA can there- fore initiate proposed rulemaking to withdraw any preauthorization and disallow all known PFAS used in pesticides as either active or inert ingredients. It would do so by issuing public notice of the pro- posed rule, followed by a standard 60-day notice-and-comment pe- riod, and a final rule.298 This action by itself does not guarantee that no PFAS would ever be permitted as a pesticide ingredient. Rather, it changes the approval process and documentation required. Whereas preapproved ingredients can be readily used in product formulations without additional registration or approval, ingredients removed from the approved list require a new use application, which must include “studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity, as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative,” and must be reviewed on a case-by- case basis by EPA before those ingredients can be included in a product.299 2. EPA Could Set PFAS Tolerances for Food Products More significantly, explicitly recognizing PFAS under the definition of “pesticide chemicals” would also permit EPA to mandate testing for PFAS residue in food products. In addition to FIFRA’s licensing scheme, the FDCA requires that EPA set tolerance limits for any pes- ticide residue found on food products moving in interstate com- merce.300 This tolerance is the maximum permissible level of reside that EPA has determined to be safe, which “means that the Adminis- trator has determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other ex- posures for which there is reliable information.”301 A tolerance (or an exemption from tolerance) must be set for all active and inert in- 298. 7 U.S.C. § 136. See, e.g., Removal of Certain Inert Ingredients From the Approved Chemical Substance List for Pesticide Products, 81 Fed. Reg. 90356 (Dec. 14, 2016) (removing 72 chemicals from the list of pre-approved inert ingredients). 299. Removal of Certain Inert Ingredients From the Approved Chemical Substance List for Pesticide Products, 81 Fed. Reg. 90356, 90357 (Dec. 14, 2016). 300. 21 U.S.C. § 346a(b)(1). 301. 21 U.S.C. § 346a(b)(2)(A). 340 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 gredients in a pesticide formulation.302 If a tolerance is not set for a certain compound found in pesticides or if a previously-set tolerance is exceeded, the affected product is subject to enforcement actions, including seizure and removal from the market.303 Tolerances can be set for both raw commodities and processed products separately, if the processing increases the pesticide concentration in the final product.304 Otherwise, a tolerance set for a raw agricultural com- modity automatically applies to any processed product that contains the raw commodity as an ingredient.305 While tolerances under the FDCA operate in tandem with pesticide product registration under FIFRA, there are three important caveats for present purposes. First, the tolerance level does not discriminate between residue present on the commodity due to direct pesticide use and residue from other environmental sources. Because many controlled pesticide chemicals (like DDT and glyphosates) are per- sistent in the environment, food products may get contaminated not only by direct pesticide application, but also by exposure to other contaminated media (like soil and water).306 In setting the appro- priate tolerance, EPA considers the amount of the chemical likely to remain on food after pesticide application.307 The EPA Administra- tor also “may”—but does not have to—exclude a substance from regulation if he determines that residue on food is “attributable pri- 302. Pesticide Registration Manual: Chapter 11 — Tolerance Petitions, U.S. ENV'T PROT. AGENCY (last updated June 26, 2023), https://www.epa.gov/pesticide-registration/pesticide- registration-manual-chapter-11-tolerance-petitions#main-content [https://perma.cc/EL5F- 2GST]; see also 21 U.S.C. § 346 (regulating the “[t]olerances for poisonous or deleterious sub- stances in food”). Of note, 21 U.S.C. § 321(q)(1)(B) excludes from the definition of “pesticide chemical” for purposes of setting tolerances any substance that is applied to food packaging or certain other types of food contact materials for the express purpose of “prevent[ing], de- stroy[ing], repel[ing], or mitigat[ing] microorganisms (including bacteria, viruses, fungi, proto- zoa, algae, and slime),” subject to some exceptions. Although 83 PFAS substances are author- ized by FDA for use in food contact materials, including food packaging, none of these are used for this express purpose. Therefore, this section does not provide reason to exclude any PFAS from the definition of pesticide chemical. 303. 21 U.S.C. §§ 331(a), 342(a)(2)(B), 346a(a). 304. See 40 C.F.R. § 180.7(b)(10) (2009). 305. 21 U.S.C. § 346a(a)(2). 306. See, e.g., U.S. FOOD & DRUG ADMIN., PESTICIDE RESIDUE MONITORING PROGRAM FISCAL YEAR 2021 PESTICIDE REPORT (2021) (discussing DDT’s persistence in the environment and resultant food contamination); see also Ramdas Kanissery et al., Glyphosate: Its Environmental Persis- tence and Impact on Crop Health and Nutrition, 8 PLANTS 499 (2019) (discussing the persis- tence of glyphosates). 307. Setting Tolerances for Pesticide Residues in Foods, U.S. ENV’T PROT. AGENCY (last updated May 11, 2023), https://www.epa.gov/pesticide-tolerances/setting-tolerances-pesticide- residues-foods#food-safety [https://perma.cc/2LAZ-HMKX]. 2024] Bystanders to a Public Health Crisis 341 marily to natural causes or to human activities not involving the use of any substances for a pesticidal purpose in the production, storage, processing, or transportation of any raw agricultural commodity or processed food” and, “after consultation with the [HHS] Secretary, determines that the substance more appropriately should be regu- lated under one or more” different provision(s).308 The EPA Admin- istrator also “may”—but does not have to—exclude a substance from regulation if he determines that residue on food is primarily at- tributable to natural causes or other human activity and, after con- sultation with the HHS Secretary, determines that the substances should be regulated under a different provision.309 But, once EPA sets a tolerance limit after taking these factors into account, it is not EPA’s burden under this provision to establish the actual route of contamination for each individual product.310 In the case of PFAS, studies demonstrate that PFAS in pesticide formulations are increas- ingly more common in agriculture, can transfer onto food, and can also stay in the environment and cause long-term contamination.311 Although PFAS in food may be present from many different routes unrelated to pesticide use, given the lack of PFAS regulation under any other provisions, the EPA Administrator should use his statutory discretion to include PFAS in the definition of a pesticide chemical residue. Once he does so, a tolerance will be in effect for PFAS resi- due from any source. Second, prior registration of a pesticide chemical under FIFRA is not required for EPA to set a tolerance for the pesticide’s ingredi- ents.312 Where a pesticide is registered abroad, for example, EPA can still set a tolerance for that product’s ingredients, at least for import- ed foods.313 Therefore, even if EPA has not formally registered a pes- ticide formulation containing PFAS, it may nonetheless act under this provision on the ground that pesticides used in the European Union and other foreign countries do contain PFAS, and therefore pesticide residue containing PFAS must be monitored for goods imported into the U.S. Lastly, active and inert ingredients found in pesticides are 308. 21 U.S.C. § 321(q)(3). 309. 21 U.S.C. § 321(q)(1)(B)(3). 310. Cf. 21 U.S.C. § 346a(a). 311. See generally Diogo A.M. Alexandrino et al., Revisiting Pesticide Pollution: The Case of Fluorinated Pesticides, 292 ENV’T POLLUTION 1 (2022) (discussing the increasing market share of fluorinated pesticides and their activity as both biocides and as environmental pollutants). 312. Kate Z. Graham, Federal Regulation of Pesticide Residues: A Brief History and Analysis, 15 J. FOOD L. & POL'Y 98, 110 (2019). 313. Id. 342 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 subject to tolerance limits and can be the basis for tolerance viola- tions even after EPA disallows the use of that ingredient in a pesti- cide formulation.314 In other words, even if EPA declares all PFAS banned from use in pesticides under FIFRA, it still has authority un- der the FDCA to mandate testing for PFAS residue based on prior ev- idence of PFAS use in pesticides.315 EPA can set, modify, or revoke tolerances in response to public pe- titions or on its own initiative, by initiating a dietary risk assessment and issuing notice of proposed rulemaking followed by a 60-day pe- riod for public comments.”316 After a final rule, the agency would ac- cept potential objections and may grant a public evidentiary hearing if the requestor has shown “a genuine and substantial issue of fact” in determining whether “there is a reasonable certainty that no harm would result from aggregate exposure to the pesticide chemical resi- due.”317 In determining tolerance levels, EPA takes into account tox- icity levels, the amount of the chemical remaining on the crop as- suming application of the pesticide at the maximum proposed usage rate, data from animal feeding studies to determine the amount of a pesticide chemical that could be present in muscle, milk, eggs, etc., and the amount of the chemical present in drinking water.318 The 1996 FQPA amended the FDCA to add that EPA must also consider the “aggregate exposure to the pesticide chemical residue” from “all 314. See, e.g., Carbofuran; Final Tolerance Revocation, 74 Fed. Reg. 23,046 (May 15, 2009); Carbofuran; Order Denying FMC's Objections and Requests for Hearing, 74 Fed. Reg. 59,608 (Nov. 18, 2009). In these actions, EPA both revoked a prior tolerance for carbofuran residue on food and also revoked a prior FIFRA registration of carbofuran usage in pesticide applica- tions. Despite the FIFRA registration withdrawal, carbofuran remained a regulated substance for purposes of FDCA and tolerance enforcement and any residue of the substance found on domestic products constituted a tolerance violation subject to enforcement. See also U.S. FOOD & DRUG ADMIN., PESTICIDE RESIDUE MONITORING PROGRAM FISCAL YEAR 2021 PESTICIDE REPORT (2021), https://www.fda.gov/media/173207/download?attachment [on file with the Journal] (“This activity is carried out pursuant to the enforcement of tolerances established by EPA and includes the monitoring of food for residues of cancelled pesticides used in the past that per- sist in the environment, which may be addressed by the FDA action levels.”) 315. For banned chemicals that persist in the environment, such as DDT, the FDA may also set advisory, non-enforceable “action levels” to monitor for the long-term occurrence of these substances in the food supply. See, U.S. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY: ACTION LEVELS FOR POISONOUS OR DELETERIOUS SUBSTANCES IN HUMAN FOOD AND ANIMAL FEED (Aug. 2000), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance- industry-action-levels-poisonous-or-deleterious-substances-human-food-and-animal-feed [on file with journal]. 316. 21 U.S.C. §§ 346a(d)(2), 346a(f)(1). 317. 21 U.S.C. §§ 346a(e)(1)(A), 346a (g)(2); 40 C.F.R. 178.32(b). 318. William R Reeves et al., Assessing the Safety of Pesticides in Food: How Current Regula- tions Protect Human Health, 10 ADVANCED NUTRITION 80, 84 (2019). 2024] Bystanders to a Public Health Crisis 343 anticipated dietary exposures and all other exposures for which there is reliable information,” and the cumulative effects of sub- stances that have a “common mechanism of toxicity.”319 Therefore, although EPA must set a separate tolerance for each pesticide ingre- dient’s use on each food commodity, it should consider ingredients with common mechanism of toxicity as a class when determining safety and tolerance limits. It also must consider a tenfold margin of safety for products consumed by infants and children.320 EPA has already determined through “substantial examination” that certain PFAS are not safe for consumption at any level.321 Con- sidering the “aggregate exposure” to PFAS from all identifiable sources—including food, drinking water, indoor and outdoor air pol- lution, and other product usage (such as cosmetics, clothing, etc.)— and the cumulative effects of all known PFAS with a “common mech- anism of toxicity,” EPA could reasonably determine that no safe tol- erance exists for PFAS residue on food products.322 Because PFAS in food may be an unavoidable byproduct of our current contaminated environment,323 however, EPA may choose to set a low residue tol- erance at the current level of laboratory detection capabilities (4 ppt).324 Importantly, the regulations permit EPA to regulate a class of chemicals by mandating that “the tolerance for the total of such residues shall be the same as that for the chemical having the lowest numerical tolerance in the class.”325 Under this provision, EPA can thus set a tolerance limit for all PFAS, rather than merely for the in- dividual substances that it has studied. Indeed, to address the issue of under-detection of PFAS that is so prevalent in most commercial labs, scientists have pioneered novel testing methods looking at total extracted organic fluorine (which prevents interference from inor- ganic fluoride through extraction methods) as a reliable indication of 319. 21 U.S.C. § 346a(b)(2)(A)(ii). 320. 21 U.S.C. § 346a(b)(2)(C). 321. See Proposed PFAS National Primary Drinking Water Regulation, U.S. ENV’T PROT. AGENCY (last updated Feb. 12, 2024), https://www.epa.gov/sdwa/and-polyfluoroalkyl- substances-pfas [https://perma.cc/N4F3-UEPU]. 322. See About Pesticide Tolerances, U.S. ENV’T PROT. AGENCY (last updated Sept. 25, 2023), https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances#:~:text=EPA%20 establishes%20tolerances%20for%20each,in%20and%20around%20the%20home [https://perma.cc/H4N6-PYZJ] (noting that EPA considers the aggregate, non-occupational exposure from the pesticide chemical “through diet and drinking water and pesticides used in and around the home”). 323. 21 U.S.C. § 346a(l)(4). 324. 21 U.S.C. § 346a(b)(3)(B). 325. 40 C.F.R. 180.3 (2014). 344 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 known and unknown PFAS compounds in the tested medium.326 Us- ing this method, a level of 4 ppt of total organic fluorine would be sufficient to trigger enforcement action for an adulterated food product without the need to identify specific PFAS compounds and their respective concentrations.327 If methods of detection improve in the future, making it reliably feasible to detect quantities lower than 4 ppt, EPA always has the option to modify or altogether revoke these tolerances, thus mandating a zero level of PFAS residue in food.328 Following the establishment of such limits, USDA and FDA would be charged with inspection, testing, and seizure where products are found to exceed EPA’s threshold.329 EPA would need to work with U.S. Customs to systematically enforce these tolerances for imported foods as well.330 V. ADVANTAGES AND CHALLENGES “There are risks and costs to a program of action. But they are far less than the long-range risks and costs of comfortable inaction.” John. F. Kennedy331 Any action that has the potential to effectively curb the occurrence of PFAS in food is also likely to face stringent opposition by the chemical, agricultural, and food industries. This section catalogues the advantages of the proposed solution and responds to some antic- ipated criticism. It concludes that, even though the proposed ap- proach is not without challenges, none of the arguments likely to be levied against it have sufficient merit to prevent its implementation and the potential difficulties pale by comparison to the grave cost of inaction. 326. See, e.g., L. Schultes, et al., Total Fluorine Measurements in Food Packaging: How Do Current Methods Perform?, 6 ENV’T SCI. TECH. LETTERS 73, 73–78 (2019). 327. 21 U.S.C. § 342. Notably, inert ingredients in food packaging treated with a pesticide are specifically exempted from the definition of “pesticide chemical residue” and are instead expressly regulated only as food additives by FDA. See 40 C.F.R. 180.4 (2008). Aside from PFAS in food contact materials, however, setting a tolerance limit for any PFAS otherwise present in or on food products as residue would cover most of the possible contamination of food. 328. 21 U.S.C. § 346a. 329. 21 U.S.C. § 342. 330. 19 C.F.R. 12.110–12.117 (2016). 331. Promoting Innovation, U.S. DEP’T OF STATE, https://2009-2017.state.gov/s/dmr/qddr /240919.htm. 2024] Bystanders to a Public Health Crisis 345 A. Anticipated Benefits The proposed regulatory mechanism has several key advantages over previously discussed approaches. First, it is readily imple- mentable with a simple 60-day notice-and-comment period, fol- lowed by adjudication on any filed objections.332 To be sure, EPA cannot make arbitrary or unsupported decisions.333 So, the realistic period of implementation would certainly be longer to account for the necessary scientific studies, assessments, and deliberation. However, considering the many PFAS-related actions EPA has taken over the last two years in other areas,334 the agency already has a tremendous amount of data and analysis compiled that can support its determinations here. Second, the proposed action effectively circumvents or addresses the PFAS-specific regulatory challenges identified earlier in this arti- cle. Because this approach hinges on the result—the presence of chemical residue on food—it does not require EPA or other regula- tors to trace the actual routes of individual product contamination or to tailor rules designed to address each potentially contaminated medium.335 Because the action is limited to PFAS use in pesticide formulations, it is less likely to encounter the type of stringent indus- try opposition faced by total ban proposals. Lastly, although the proposal relies on EPA’s primacy in promulgating pesticide regula- tion, it in no way precludes FDA, USDA, or any other actor in the field from taking additional PFAS-related actions. Third, the proposal would accomplish two distinct and important goals. In the more immediate term, it would protect consumers from food contaminated with PFAS by allowing for widespread monitor- ing and removal of adulterated food from the market. In the long term, it would also serve as an information forcing mechanism which is sorely needed to fill the gap in data about the actual spread of PFAS in our food supply, including the types of food products and processing environments most susceptible to contamination. This data in turn can inform potential remediation strategies, scientific 332. 21 U.S.C. §§ 346a(d)(2), 346a(f)(1), 346a(g)(2). 333. See, e.g., Red River Valley Sugarbeet Growers Ass'n v. Regan, 85 F.4th 881, 888 (8th Cir. 2023) (overturning EPA’s total ban on chlorpyrifos in pesticide formulations because it held that EPA “reflexively rejected an approach it had the power to adopt.”). 334. See supra Part IV. 335. See 21 U.S.C. § 346a(b)(2)(A)(ii) (directing EPA to look at cumulative exposure from all sources). 346 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 research efforts, and public policy designed to support farmers and food producers. And it can help push forward future actions by oth- er regulators or even legislative reform, thus ensuring a more per- manent, long-term solution to this public health crisis. B. Major Questions Doctrine Considering the significant expansion of the major questions doc- trine in recent years,336 the most immediate obstacle for any attempt to assert agency jurisdiction is likely to come in the form of a judicial challenge invoking the major questions doctrine. Although a thor- ough discussion of the doctrine’s contours and implications is be- yond the scope of this article, there are three significant reasons why a major questions challenge is not likely to succeed here, even at the current Supreme Court.337 First, an EPA decision to regulate PFAS as pesticide residue in food is not an expansion of EPA’s current authority and thus should not invoke the major questions doctrine. Unlike FDA’s attempt to regu- late tobacco under its authority over “drugs” and “devices,”338 or the CDC’s proposed reach to institute a nationwide eviction moratorium under its authority to prevent the spread of diseases,339 here, EPA would not be seeking to regulate a new class of products or to reach outside its purview. Rather, it would simply be using its existing au- thority over pesticide residue in food to monitor and regulate one additional class of pesticide chemicals. EPA has previously used its authority both under FIFRA to ban the use of various other active or inert ingredients in pesticides and under the FDCA/FQPA to subse- quently set or revoke tolerances for the occurrence of those same chemicals in food products.340 As early as 1972, only two years after 336. See Daniel Deacon & Leah Litman, The New Major Questions Doctrine, 109 VA. L. REV. 1009, 1012 (2003) (noting that the major questions doctrine is “perhaps the most important [] constraint on agency power, particularly when it comes to some of the most pressing problems of our time”). 337. See generally id. (describing the Court’s rapid expansion and politization of the doc- trine to limit agency action). 338. See U.S. Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 120 (2000). 339. Ala. Ass’n of Realtors v. U.S. Dep’t of Health & Human Servs., 141 S. Ct. 2485, 2487 (2021). 340. Cf. id. at 2487, 2489, (striking down an agency action that was “unprecedented,” and where EPA asserted “newfound” authority that had “rarely been invoked” in the preceding decades); Biden v. Nebraska, 143 S. Ct. 2355, 2372 (2023) (holding that the major questions 2024] Bystanders to a Public Health Crisis 347 its creation, EPA used its authority under FIFRA to ban almost all ag- ricultural uses of DDT.341 It has since banned a number of active pesticide compounds, such as ethylene dibromide.342 It has also re- voked prior authorizations under FIFRA for inert ingredients. Nota- bly, in 2016, it removed seventy-two chemicals from the list of ap- proved inert pesticide ingredients.343 And, as explained earlier, in 2022, it even revoked its prior authorization on the use of 12 PFAS substances from the inert ingredient list.344 This action has gone un- challenged to date. EPA has also used its authority under FDCA and FQPA to revoke related residue tolerances in food. In 1985, for ex- ample, it issued a zero tolerance for ethylene dibromide in imported fruit.345 In 2009, EPA issued a final rule revoking all tolerances for carbofuran,346 and, more recently, in 2022, it did the same for chlorpyrifos.347 Importantly, EPA has also used its authority to set doctrine was properly invoked where the authority in question “has been used only once be- fore to waive or modify a provision related to debt cancellation”). 341. 37 Fed. Reg. 13369 (July 7, 1972). EPA did not immediately set tolerance for DDT in food, however, because DDT was so widely used and present in the environment, that banning all food that contained it “would seriously affect the total food supply.” United States v. Good- man, 486 F.2d 847, 855 (7th Cir. 1973). 342. See Nat’l Coal. Against the Misuse of Pesticides v. Thomas, 809 F.2d 875, 876 (D.C. Cir. 1987). 343. News Release, U.S. Env’t Prot. Agency, EPA Prohibits 72 Inert Ingredients from Use in Pesticides, (Dec. 20, 2022), https://19january2017snapshot.epa.gov/newsreleases/epa- prohibits-72-inert-ingredients-use-pesticides_.html#:~:text=WASHINGTON%2D%2DThe%20 U.S.%20Environmental,information%20to%20demonstrate%20their%20safety [https://perma.cc/TN8T-6WCT]. 344. See EPA Stops Use of 12 PFAS in Pesticide Products, U.S. Env’t Prot. Agency (Dec. 14, 2022), https://www.epa.gov/pesticides/epa-stops-use-12-pfas-pesticide-products [https://perma.cc/RQ8L-MLUX]. Alarmed by the findings of the September 2022 study, EPA attempted to repeat the testing and announced that its own lab found no detectable PFAS in the tested samples. See Memorandum from Yaorong Qian, supra note 288. 345. See Nat’l Coal. Against The Misuse of Pesticides, 809 F.2d at 876. 346. See, e.g., Carbofuran; Final Tolerance Revocation, 74 Fed. Reg. 23046 (May 15, 2009); Carbofuran; Order Denying FMC's Objections and Requests for Hearing, 74 Fed. Reg. 59608 (Nov. 18, 2009). 347. EPA Takes Next Step to Keep Chlorpyrifos Out of Food, Protecting Farmworkers and Children’s Health, U.S. ENV’T PROT. AGENCY (Dec. 14, 2022), https://www.epa.gov /newsreleases/epa-takes-next-step-keep-chlorpyrifos-out-food-protecting-farmworkers-and- childrens#:~:text=In%20August%202021%2C%20EPA%20issued,cauliflower%2C%20and %20other%20row%20crops [https://perma.cc/74UZ-4CP9]. The Eighth Circuit recently overturned EPA’s blanket revocation of tolerances on the grounds that EPA had not sufficiently considered eleven potential beneficial uses of the pesticide chemical. The court noted, howev- er, that, on remand, “the agency remains free to exercise its discretion as long as it considers all ‘important aspect[s] of the problem’ and gives a reasoned explanation for whichever option it chooses.” Red River Valley Sugarbeet Growers Ass’n v. Regan, 85 F.4th 881 (8th Cir. 2023) 348 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 tolerances for ingredients that are used in applications other than pesticides, such as for arsenic.348 Given the routine exercise of the asserted regulatory power in the past, there is no reason to consider EPA’s regulation of additional substances of that same class under this authority as somehow expanding upon EPA’s existing powers or as presenting the type of “extraordinary case” that would invoke the doctrine.349 Second, even if the major questions doctrine is invoked, the pro- posed action is not likely to satisfy the definition of “major”-ness. According to the most expansive definition of the doctrine, as out- lined in West Virginia v. EPA and Biden v. Nebraska, a question would be considered “major” when the use of the claimed regulatory power (1) has “economic and political significance,”350 (2) has been consid- ered and rejected by Congress,351 (3) “effec[ts] a ‘fundamental revi- sion of the statute, changing it from [one sort of] scheme of . . . regu- lation’ into an entirely different kind,”352 or (4) has future implications for the agency’s authority, including its ability to “in- trud[e] into an area that is the particular domain of state law.”353 None of these factors cut against the proposed EPA actions here. For one, the solution does not seek to regulate the manufacture, commerce, or discharge of PFAS at all. As such, it has no direct eco- nomic impact on the chemical industry. The economic impact on the pesticide industry depends on the extent to which PFAS are current- ly used as active and inert ingredients—and part of the problem is that, due to lack of testing and regulation, that figure is currently un- known and impossible to ascertain. As a point of comparison, EPA conducted a thorough economic review of the DDT ban in 1972, tak- ing into account not only the impact on DDT manufacturers but also on crops heavily dependent on the pesticide at the time, such as cot- ton.354 EPA concluded that the costs are “of insufficient magnitude (citations omitted). EPA is in the process of renewing its ban on all but those eleven uses and reissuing its tolerance revocations. 348. C.F. Jelinek & P.E. Corneliussen, Levels of Arsenic in the United States Food Supply, 19 ENV’T HEALTH PERSPS. 83 (1977). 349. West Virginia v. EPA, 142 S. Ct. 2587, 2607–08 (2022). 350. See id. at 2608. 351. See Biden v. Nebraska, 143 S. Ct. 2355, 2373 (2023) (stating that “Congress is not un- aware of the challenges facing student borrowers” and has in the past considered more than eighty student loan forgiveness bills). 352. Id. at 2373. 353. West Virginia, 142 S. Ct. at 2621 (Gorsuch. J., concurring). 354. U.S. ENV’T PROT. AGENCY, EPA-540/1-75-022, DDT: A REVIEW OF SCIENTIFIC AND ECONOMIC ASPECTS OF THE DECISION TO BAN ITS USE AS A PESTICIDE (July 1975). 2024] Bystanders to a Public Health Crisis 349 to cause sizeable shifts in economic parameters at the regional or na- tional level.”355 Because PFAS are neither vital nor irreplaceable as pesticide ingredients,356 a ban on their use would likely have an even more negligible economic impact on the pesticide industry or the cost of food manufacturing. The biggest economic impact that the solution would have would be on food producers affected by mandatory recalls. Here too, the extent of the impact is impossible to predict due to the scarcity of current data. A useful gauge is the experience of Maine, which has now instituted systematic testing for the presence of PFAS on farms. In 2023, after discovering a staggering number of PFAS- contaminated farms in the state, Maine created a PFAS fund designed to provide direct support to farmers affected by the issue. The fund totals $70 million for fiscal years 2024-2028, of which $30.3 million are allocated for helping farmers (including direct income replace- ment payments), $21.5 million are for compensation for contaminat- ed land, $7.3 million are to cover medical expenses, and $11.2 mil- lion are earmarked for scientific research.357 Multiplied by 50 states (assuming equal levels of contamination across the nation), the total annual economic impact would be a mere $700 million. Even mak- ing room for the fact that some state’ economies are much more ag- riculture-dependent than Maine, the total economic impact would still be a far cry from the $430 billion of student loans affected by the Biden administration’s proposed loan forgiveness program that the Court struck under the doctrine.358 This figure also pales by compar- ison to the costs that EPA, municipalities, and other stakeholders are incurring and anticipating in relation to EPA’s (as of yet unchal- lenged in court) actions to address PFAS contamination of water.359 355. Id. at 194. 356. See, e.g., Pesticides: Proposed Removal of Per- and Polyfluoroalkyl Substance Chemi- cals from Approved Inert Ingredient List for Pesticide Products 87 Fed. Reg. 56051 (Sept. 13, 2022) (noting that none of the PFAS that EPA chose to ban “are currently being used as an in- ert ingredient in a pesticide product” and “EPA believes it is appropriate to remove these chemicals from the inert ingredient list in order to prevent the introduction of these PFAS into pesticide formulations without additional EPA review”). 357. ME. DEP’T OF AGRIC. CONSERVATION & FORESTRY, PLAN FOR THE ADMINISTRATION OF THE FUND TO ADDRESS PFAS CONTAMINATION (July 10, 2023), https://www.maine.gov/dacf/about /commissioners/pfasfund/docs/draft-all-plan-admin-of-pfasfund-final.pdf [https://perma.cc/63QX-Y4F5]. 358. See Biden v. Nebraska, 143 S. Ct. at 2362. 359. See, e.g., Alissa Cordner et al., The True Cost of PFAS and the Benefits of Acting Now, 55 ENV’T SCI. TECH. 9630, 9631 (2021) (noting that the cost of cleaning up PFAS from drinking wa- ter in California alone would cost around $1 billion). 350 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 Moreover, any economic impact to food producers—which occurs even today, absent EPA action—can be mitigated at the federal level. USDA already administers a Dairy Indemnity Payment Program that covers direct payments to farmers due to PFAS contamination of their dairy,360 and the currently proposed Relief for Farmers Hit with PFAS Act likewise seeks to minimize the economic impact of PFAS food contamination on food producers.361 Finally, the Maine blue- print demonstrates that systematic testing and data-gathering ef- forts actually decrease costs to all stakeholders in the long run, as they reveal likely paths of contamination and make quick and effec- tive remediation possible.362 The economic impact of the proposed measure, therefore, is not likely to be significant.363 Nor is the question of regulating PFAS as pesticide residue in food one of significant political importance. Mitigating PFAS’ presence in the environment is certainly a relevant and pressing issue—though it is also one that garners somewhat bipartisan support.364 However, as this article makes clear, the issue of PFAS in food unfortunately has gone largely unnoticed and unaddressed to date. What attention is directed at this issue is in the form of concern for consumer safety, rather than the type of stringent opposition or “robust debate” envi- sioned by the majority and concurrence in West Virginia v. EPA.365 Indeed, not one of the 53 PFAS-related bills proposed in Congress last term sought to regulate the occurrence of PFAS in food products, let alone the use of PFAS as pesticide ingredients or their occurrence on food products as pesticide residue.366 There is a good reason for 360. Dairy Programs, U. S. DEP’T OF AGRIC., https://www.fsa.usda.gov/programs-and- services/farm-bill/farm-safety-net/dairy-programs/index#:~:text=Dairy%20Indemnity%20 Payment%20Program,by%20pesticides%20and%20other%20residues. 361. Relief for Farmers Hit with PFAS Act, S. 747, 118th Cong. (2023). 362. See, e.g., Vivien Leigh, Maine Dairy Farm Coming Out of Toxic Nightmare from ‘Forever Chemicals’, NEWS CTR. ME (Mar. 8, 2023), https://www.newscentermaine.com/article /tech/science/environment/pfas/dairy-farm-coming-out-of-a-toxic-nightmare-from-forever- chemicals-pfas-environment-maine-business-agriculture/97-96c362b4-f9fd-42e8-9591- eeb69726c4f4 [https://perma.cc/AGC2-33MS]. 363. In any event, the FDCA allows EPA administrator to exempt certain substances from regulation under the residue tolerance provisions if “[u]se of the pesticide chemical that pro- duces the residue is necessary to avoid a significant disruption in domestic production of an adequate, wholesome, and economical food supply.” 21 U.S.C. § 346a(b)(2)(B)(iii). 364. See, e.g., Press Release, Congressman Mike Lawler, Reps. Lawler and Kileed Introduce Legislation to Provide Access to Health Care for Veteran Exposed Toxic to PFAS Chemicals (June 21, 2023), https://lawler.house.gov/news/documentsingle.aspx?DocumentID=449 [https://perma.cc/FTX6-2ECX]. 365. West Virginia v. EPA, 142 S.Ct. 2587, 2620–21 (2022) (Gorsuch, J., concurring). 366. See supra Part IV(B). 2024] Bystanders to a Public Health Crisis 351 that: not only is this issue not on legislators’ radar as a major politi- cal concern, but EPA already has been granted authority (way back in 1972 and repeatedly thereafter) to regulate all pesticide chemicals and their residues on food. In the words of Justice Barrett, the pro- posed solution in this article is very much in EPA’s “wheelhouse.”367 Finally, an EPA rule under its FIFRA, FDCA, and FPQA authority does not threaten a future impermissible expansion of that power. That authority is statutorily confined to regulating chemicals that are ac- tually used in pesticide formulations—an inherently limited class. Nor is the issue treading on states’ rights; rather, it implicates a fun- damentally federal power and the few states that have turned their attention to the problem of PFAS in food are in fact actively soliciting federal action.368 Third, even if somehow the proposal rises to the level of a major question, Congress has provided clear authority to EPA to act under the applicable federal statutes.369 While the Supreme Court has not yet qualified what level of clarity is required for an agency to pass this test, EPA’s grant of authority to regulate pesticide residues in food can meet any level of stringency. EPA itself was created on the premise that it should serve as “the nucleus” for “dealing with air and water pollution, pesticides registration and regulation, solid waste management, and radiation standard-setting, including their closely related monitoring and research facilities.”370 Shortly after its creation,371 EPA was explicitly endowed with authority not only over pesticide registration and regulation, but also, over pesticide residues in food—authority that was explicitly transferred from FDA and USDA to EPA.372 Subsequent amendments of the pesticide regulatory scheme con- tinued to grant EPA augmented power over this area. The legislative 367. Biden v. Nebraska, 143 S. Ct. 2355, 2382 (Barrett, J., concurring). 368. Letter from Gov. Mills to U.S. Senators, Re: Request for federal funding to address con- tamination from per- and poly-fluoroalkyl substances (PFAS) (March 25, 2021), https://www.maine.gov/governor/mills/news/letter-maines-congressional-delegation- governor-mills-urges-federal-government-provide-funding [https://perma.cc/Q44N-R9TF]. 369. See West Virginia, 142 S. Ct. at 2616 (Gorsuch, J., concurring) (describing the Court’s articulation of the major questions doctrine as a clear statement rule). 370. Ash Council Memo, Memorandum from the President’s Advisory Council on Executive Organization to President Nixon (Apr. 29, 1970), https://www.epa.gov/archive/epa/aboutepa /ash-council-memo.html, [https://perma.cc/K6AX-DXVA] (emphasis added). 371. Reorganization Plan No. 3 of 1970, 35 Fed. Reg. 15, 623 (1970), reprinted in 42 U.S.C. §4321. 372. Federal Environmental Pesticide Control Act of 1972, Pub. L. No. 92-516, 86 Stat. 973 (1972). 352 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 history of the FQPA, for example, demonstrates that, at that time, Congress debated what could be considered a major political issue. Representative John Dingell described the enactment of the act as “a historic moment, for today we consider in the House a piece of legis- lation that literally has been pending before Congress for over a dec- ade” and “an amazing compromise that has been reached, which has brought together some of the most staunch and bitter rivals in this debate.”373 Congress’ clear delegation of authority to EPA on this is- sue was the resolution of this bitter political debate and “the product of that successful negotiation.”374 By explicitly endowing EPA with sole authority over “establishing safety tolerances that apply to all Americans,”375 the FQPA “overhaul[ed] the way the Government regulates pesticides, and at long last deals with the thorny issue of differing standards for different kinds of food products.”376 Moreo- ver, not only did Congress grant EPA express authority to regulate pesticide residue—of any pesticide chemical, inert or active377—but it also “provide[d] wide latitude for the Environmental Protection Agency to adapt its regulatory system to meet the constantly im- proving scientific information that is available.378 Whatever the expansive reach of the major questions doctrine may be nowadays, a challenge under this theory is unlikely to succeed against the actions outlined in this article. C. Temporary Nature of the Solution The proposed solution may also be viewed skeptically for its in- herently temporary nature, being vulnerable to the political whims of whichever administration happens to be in power. As an initial matter, this criticism can be levied against any agency action grounded in regulatory authority and cannot, by itself, be a sufficient reason not to engage in what is otherwise a viable step to resolving a pressing problem. Beyond that, the phenomenon of regulatory iner- tia—ordinarily studied for its deleterious effects on progress in rule- making—tells us that, once an agency enacts a rule, it is much more likely to adhere to it even in the face of changing circumstances that 373. 142 CONG. REC. H8143 (daily ed. July 23, 1996) (statement of Rep. John Dingell). 374. Id. 375. 142 CONG. REC. H8143 (daily ed. July 23, 1996) (statement of Rep. Henry Waxman). 376. 142 CONG. REC. H8143 (daily ed. July 23, 1996) (statement of Rep. John Dingell). 377. 21 U.S.C. § 321(q)(1)(A). 378. 142 CONG. REC. H8141 (daily ed. July 23, 1996) (statement of Rep. Pat Roberts). 2024] Bystanders to a Public Health Crisis 353 may warrant a reversal of the agency’s previous decision.379 A change in administration, therefore, is unlikely to undo all that has been set in motion, or at least not immediately. Indeed, during the Trump Administration, despite an overall decline in enforcement ac- tions,380 EPA continued to aggressively implement existing measures to curb the spread of PFAS in the environment.381 Most importantly, the proposed solution here does not aim to be permanent. Rather, it seeks to serve as an information forcing mechanism to engender future, more permanent Congressional ac- tion, all-the-while bridging the gap between now and that hypothet- ical future by immediately addressing the final-stage issue of PFAS- contaminated food through a monitoring and enforcement mecha- nism. D. Limited Testing Capabilities Lastly, although EPA would be the actor banning the use of PFAS in pesticides and establishing tolerances in food, the ultimate imple- mentation of the proposal—testing and enforcement—would still fall in the hands of USDA and FDA. Given these agencies’ demon- strated unwillingness to engage with the issue of PFAS and general difficulties in enforcing food safety standards, it is reasonable to ex- press doubt at their ability to effectively partner with EPA to make this a workable solution. There are, however, key differences be- tween relying on USDA and FDA to set policy and promulgate rules, on the one hand, and to enforce EPA-mandated standards, on the other. While the agencies suffer from significant encumbrances and dysfunction in promulgating safety rules, they are equipped to ad- minister EPA’s tolerances in a wide array of commodities. These dif- ferences prompted the original division of responsibilities in the 1970s: FDA and USDA’s failure to address the issue of pesticide 379. Asaf Eckstein, Regulatory Inertia and Interest Groups: How the Structure of the Rule- making Process Affects the Substance of Regulations, MICH. BUS. & ENTREPRENEURIAL L. REV. (2015); see also William Samuelson & Richard Zeck, Status Quo Bias in Decision Making, 1 J. RISK & UNCERTAINTY 7 (1988). 380. New EPA Enforcement Data Show Continued Downward Trend During Trump Admin- istration, ENV’T INTEGRITY PROJECT (January 14, 2021), https://environmentalintegrity.org /news/epa-enforcement-data-downward-trend-during-trump-administration/ [https://perma.cc/SUA7-GS5G]. 381. Press Release, U.S. Env’t Prot. Agency, Trump EPA Continues to Aggressively Address PFAS on the Federal, State, and Local Level (July 28, 2020), https://www.epa.gov /newsreleases/trump-epa-continues-aggressively-address-pfas-federal-state-and-local-level [https://perma.cc/E2LA-RMYF]. 354 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 spread in the food supply prompted President Nixon and, later, Con- gress, to delegate to EPA sole registration and tolerance-setting au- thority, but the food agencies’ larger field presence and research ca- pabilities advocated in favor of “redelegating to FDA the actual enforcement of pesticide residue standards,” and to USDA the con- tinued “research on the economic effectiveness of pesticides.”382 Pursuant to this division of responsibilities, in 1991, USDA’s Agri- cultural Marketing Service designed the Pesticide Data Program, which partners with states to annually test commodities for a wide variety of pesticides. The annual sampling selection is dictated by EPA, based on its data needs for the types and amounts of food most consumed by children.383 PDP does not serve an enforcement func- tion, but it provides information to EPA, FSIS, and FDA of viola- tions.384 FDA and FSIS, in turn, conduct their own pesticide monitoring both through routine sampling of the products in their jurisdiction and through targeted samples in areas of concern.385 Under its Na- tional Residue Program, FSIS samples about 95% of domestic meat and poultry consumption.386 Unlike the statistical approach taken by FSIS, FDA conducts sampling for target commodities under its Pesti- cide Residue Monitoring Program and also partners with state agen- cies through MOUs, which allows it to receive additional field data.387 FDA is in charge of enforcing EPA’s tolerance levels in most domestic and imported food, including by recalling or seizing adulterated products.388 This type of functional allocation of jurisdiction and responsibili- ties in the food safety system has the advantage of higher effective- 382. See Ash Council Memo, supra note 370. 383. U.S. DEP’T OF AGRIC., AGRIC. MKT. SERV., PESTICIDE DATA PROGRAM 2020 ANNUAL SUMMARY, at ix (2022), https://www.ams.usda.gov/sites/default/files/media/2020PDPAnnualSummary .pdf [https://perma.cc/Q99E-742M]. 384. Id. 385. U.S. FOOD & DRUG ADMIN., PESTICIDE RESIDUE MONITORING PROGRAM FISCAL YEAR 2021, at 11 (n.d.), https://www.fda.gov/media/173207/download?attachment [https://perma.cc /AL8U-7F5N] [hereinafter FDA PESTICIDE RESIDUE MONITORING]; U.S. DEP’T OF AGRIC. FOOD SAFETY & INSPECTION SERV., U.S. NAT’L RESIDUE PROGRAM FOR MEAT POULTRY, AND EGG PRODUCT: 2019 RESIDUE SAMPLING PLANS, at 1-2 (2018), https://www.fsis.usda.gov/sites/default/files/media _file/2020-07/2019-blue-book.pdf [https://perma.cc/5XEF-9PMU] [hereinafter FSIS Residue Program]. 386. FSIS RESIDUE PROGRAM, supra note 385, at 4. 387. Compare id. at 6-7 with FDA PESTICIDE RESIDUE MONITORING, supra note 385, at 5–14. 388. FDA PESTICIDE RESIDUE MONITORING, supra note 385, at 10. 2024] Bystanders to a Public Health Crisis 355 ness, efficiency, and accountability.389 While this system could of course stand to be improved and issues of understaffing and insuffi- cient budgets are inevitably part of the discussion,390 the overall pes- ticide monitoring and enforcement scheme works much better than anything currently done regarding the presence of PFAS in food. Therefore, challenges of scale notwithstanding, by invoking USDA’s and FDA’s statutorily mandated obligation to monitor food for pesti- cide residues and to enforce EPA’s tolerances for PFAS in food, the proposed solution could make a tremendous difference in consum- ers’ daily intake of PFAS. VI. CONCLUSION “One thing is all things. To resolve one matter, one must resolve all matters. Changing one thing changes all things.” Masanobu Fukuoka391 The U.S. food regulatory regime is fractured and badly in need of reform. Over a century of division, bureaucratic infighting, and anti- quated food safety laws have produced a hopelessly paralyzed, im- potent, and broken system. The pressure of ever-increasing con- sumer demand and complex environmental, agricultural, and industrial factors further exacerbate the issue, creating numerous intractable threats to food safety. But not all hope is lost. Fortunately, it is not necessary to engage in herculean structural reform to effectively address food safety is- sues at the federal level. This article offers proof that even within the confines of this imperfect system, regulatory agencies can make considerable progress in resolving the most pressing food safety is- sues of our day. The article’s proposed solution has the potential to (1) provide regulators and legislators with ground truth about the spread of PFAS in our food supply, (2) immediately and meaningfully protect consumers from the daily threat of PFAS in their meals, (3) push forward long-term legislation banning the use of PFAS writ- large, and (4) provide concrete pathways for helping farmers and other food producers in their remediation efforts. 389. See CAMACHO & GLICKSMAN, supra note 227 at 68–69. 390. See generally Graham, supra note 312, at, 120–29. 391. MASANOBU FUKUOKA, THE NATURAL WAY OF FARMING: THE THEORY AND PRACTICE OF GREEN PHILOSOPHY 170 (1987). 356 COLUMBIA JOURNAL OF ENVIRONMENTAL LAW [Vol. 49:2 More broadly, by taking on the spread of PFAS in food as a case study, this article also offers an analytical blueprint for avoiding by- stander apathy on any other seemingly insurmountable food safety problems. Psychologists posit that general cries for help are ineffec- tive in an emergency; what is needed is a direct appeal to a single ac- tor. By laying the responsibility for acting at the feet of one concrete individual, they argue, the person in distress can break through the bystander effect and can mobilize meaningful engagement. Like- wise, by analyzing a problem through the lens of which agency is best positioned to spearhead actions on it, scholars, policymakers, and consumer safety advocates could navigate the morass of the food regulatory system more effectively and could find creative and workable ways to combat bystander apathy to other food safety threats. As the last few years of pandemic living have taught us, public health and safety must be of paramount importance to legislators and regulators alike. The fact that both our political and administra- tive systems are struggling cannot be a sufficient excuse for letting consumers unwittingly continue to ingest poisons with their every meal. Any amount of positive change and forward momentum is bet- ter than idly standing by, paralyzed by fear or apathy, as toxic chemi- cals infect our environment, our food, and—ultimately—all of us. I. Introduction II. Regulatory System in Disarray A. History of Fragmented Regulation B. The Present State of Chaos 1. The Food and Drug Administration 2. Food Safety and Inspection Service 3. The Environmental Protection Agency 4. Other Agency Actors C. More Is Not Always Better III. Regulating PFAS: A Case Study in Dysfunction and Diffused Responsibility. A. Background on PFAS B. PFAS in Our Food Supply C. Current Regulation of PFAS D. PFAS-Specific Regulatory Challenges IV. In Search of a Solution to the Crisis of PFAS in Food A. A Centralized Food Safety System B. Banning PFAS in Food Products C. Relying on FDA and USDA Authority D. Breaking Free from Bystander Apathy: Empowering EPA to Act 1. EPA Could Ban the Use of PFAS in Pesticides 2. EPA Could Set PFAS Tolerances for Food Products V. Advantages and Challenges A. Anticipated Benefits B. Major Questions Doctrine C. Temporary Nature of the Solution D. Limited Testing Capabilities VI. Conclusion