The Need to Integrate Animal Agriculture in our Approach to Food Safety

By Douglas Stearn 

I. Introduction

Despite a number of sustained efforts to improve food safety regulation, our best estimates of foodborne illness in the United States have failed to show demonstrable progress over several decades.  One piece of this apparent stagnation stems from a regulatory framework that lacks focus on gaining information about critical upstream sources of contamination from various types of animal agriculture, such as animal feeding and breeding operations, despite compelling evidence regarding the importance of these sources.  Rather, our system is focused primarily on downstream controls in slaughterhouses and food processing, manufacturing, and holding.  This article outlines the case for increasing targeted investigations earlier in the chain of causation where a potential contamination source lies in animal agriculture.  This article also identifies a regulatory gap–no federal agency is currently clearly responsible for regulating that stage of the food system’s impact on foodborne illness.  A better understanding of the connection between animal agriculture and foodborne illness has the potential to substantially reduce illnesses, hospitalizations, and deaths.

The main cause of many foodborne illnesses lies upstream.  Pathogens from animal manure can move into the environment and then contaminate produce, and some pathogens endemic to breeding stock  can contaminate poultry within the food supply chain.  Genomic sequencing and artificial intelligence now allow regulators to trace pathogens back to those upstream sources and to understand the specific conditions that lead to consumer exposure.  The Food and Drug Administration (FDA) likely has the legal authority to investigate food safety issues in animal agriculture, but has not exercised it and is not operationally prepared to do so.  Other agencies hold only fragmented pieces of jurisdiction.  Therefore, policymakers should empower FDA or another agency to oversee pathogen risks in animal agriculture in order to materially reduce foodborne illness.  Until that time, FDA should undertake targeted, risk-based investigations to increase the understanding of root cause in this area.

II. Regulatory Jurisdiction and Its Relevance

Taking actions to address food safety risks in animal agriculture practices has tremendous promise in preventing illness.  This article focuses on two key examples:the movement of human pathogens from livestock to fresh produce has been one of the most concerning food safety issues for FDA, and the movement of pathogens from poultry breeding stock to their progeny is similarly a critical issue for the Food Safety Inspection Service (FSIS).  The advance in our ability to match genomic sequences of pathogens gathered from the environment and production facilities and match them to pathogens in products and patients now gives us a new ability to understand this issue.  This progress needs a regulatory agency that can lead change in this area, using the concept of “One Health”[1] and more detailed understandings to advance substantial reductions in foodborne illness.  

A. Confusion over Jurisdiction

The odd edges of the jurisdictional divide between FDA and FSIS are a central problem in assuring food safety.  The Government Accountability Office has concluded that the fragmented nature of the federal food safety oversight system causes inconsistent oversight, ineffective coordination, and inefficient use of resources.[2]  The strangeness of many of these demarcations is clear enough.  FSIS has jurisdiction over catfish, while FDA has jurisdiction over all other fish; FSIS has jurisdiction over open-face meat sandwiches, while FDA has jurisdiction over closed-face meat sandwiches; FSIS has jurisdiction over pepperoni pizza, while FDA has jurisdiction over other pizza; and so forth.  Nonetheless, the way in which this fragmentation harms food safety is usually not explicitly spelled out.  The ways in which the lines are drawn are not difficult to mock, but the actual impact on food safety is not obvious. 

While some of the jurisdictional lines make little sense, FDA and FSIS do not ordinarily get confused about them.  To be sure, resources can be wasted in having overlapping expertise in areas like eggs and seafood, and the regulatory agencies have needed to engage in some work to assure that companies making an array of products do not need two sets of records. 

The jurisdictional question between the agencies does create a major food safety problem where neither agency has taken or accepted responsibility.  That gap in responsibility has effectively occurred in investigating and understanding the impact of animal agriculture on food regulated by both agencies. 

B. FDA Has Jurisdictional Authority

There is a relatively straightforward argument that FDA has the authority under the Federal Food, Drug and Cosmetic Act (FDCA) to inspect, sample, and take other regulatory actions related to animal agriculture facilities that keep food-producing animals prior to slaughter.  FDA has authority to take such actions related to food under the FDCA.[3]  The term “food” is broadly defined to include “articles used for food and drink for man or other animals” and “articles used for components of any such article,”[4] and the broad definition has been construed to include articles that are intended to be consumed for their nutrition, taste, or aroma, along with substances intended to be added to such products.[5]  FDA has long maintained that animals intended for human consumption are “food” under the FDCA and has with some frequency invoked authority on ranches in efforts to control the improper use of animal drugs.  As set forth in the relevant FDA compliance program, “Food-producing animals and fish, even though not in their final, edible form, have been held to be food under the statute.”[6]  While the authority is sparse, the few courts that have reviewed that position have upheld it, finding that live animals were food within the meaning of the FDCA.[7]  As FDA puts the issue directly in its own document, “live animals raised for food are ‘food’ under the [FDCA].”[8] 

FDA’s legal position on this issue arose as part of its efforts to assure antibiotics and other animal drugs were not being misused in how they were being administered in cattle and other food-producing animals.  Antibiotics and other drugs can promote growth and mitigate the commercial costs of illness even before animals become sick, and for these reasons there has been a long history of misuse of certain drugs among some producers.  Concern over the potential for creating antibiotic-resistant bacteria and inappropriate exposure to humans of antibiotics and other drugs to humans through food led to the creation of a compliance program whereby FDA would investigate and act upon FSIS testing results of slaughtered animals.  FDA began to rely on the argument that animal agriculture establishments were subject to inspection because they held “food” for commercial sales; the agency could not be assured that animal drugs would be on the premises at a particular time.  Despite this history of claimed authority, FDA appears to have never publicly taken action or asserted jurisdiction on ranches or poultry farms to investigate outbreaks of foodborne illness.   

In the case of an outbreak investigation, the purpose of entering a ranch with livestock would be tied to assuring the safety of another food grown and held for sale on another property.  Accordingly, there could be an objection to applying a literal reading of the statute because it falls outside of the agency’s normal approach where investigators would not be focused on the safety of the food produced at the facility itself.  Nonetheless, there are a number of arguments against implying such a limitation. 

In reviewing how the Act should be construed, the Supreme Court has instructed that “Congress fully intended that the [FDCA’s] coverage be as broad as its literal language indicates” without regard for conclusions some may think to be “ridiculous” in a particular case.[9]  The principle against limiting literal application of the statute stems from another, which is that “remedial legislation such as the [FDCA] is to be given a liberal construction consistent with the Act’s overriding purpose to protect the public health.”[10]  This general principle is limited where an application of FDA’s authority is at odds with the overall statutory scheme and Congress appears to have spoken directly to the issue in a way that precludes jurisdiction; in such cases the issue involves a major question where the history of the issue weighs against a wider construction of jurisdiction.[11] 

Here, there is not a compelling case to avoid the application of the words of the statute as construed by precedent.  Examination of the chain of contamination in each case does not appear to have been addressed by Congress or at odds with the objectives of the Act.  Determining the pathways by which a pathogen has contaminated food and resulted in the deaths or injuries of significant numbers of people constitutes a strong public health rationale consistent with FDA’s traditional role.  Similarly, the presence of live animals involved in breeding stock can result in the contamination of poultry products downstream when reaching the consumer.

In examining the validity of regulatory inspections in the Fourth Amendment context, the courts focus on whether the regulatory scheme is appropriately designed so as to reduce the expectation of privacy.  In order to result in that reduced expectation of privacy, the inspection scheme must pass certain tests: it must involve a substantial government interest, it is necessary to further the regulatory scheme, and inspections under the scheme must adequately limit the discretion of those conducting an inspection.  If those criteria are satisfied, inspectional conduct falling within that scheme is valid, and there is no cause for examining the motives of those involved in the inspection process itself.[12]   

As an additional authority, the Public Health Service Act (PHS Act) empowers FDA to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases.  This provision allows, among other things, the regulations to provide for inspection, disinfection and destruction of animals or articles found to be infected or contaminated as to be sources of dangerous infection to human beings.[13]  One relevant regulatory provision under the PHS Act explicitly authorizes inspection to prevent the spread of communicable diseases.[14]  Under this regulation, communicable diseases are illnesses due to infectious agents or their toxic products, which may be transmitted from a reservoir to a susceptible host either directly as from an infected person or animal or indirectly through the agency of an intermediate plant or animal host, vector, or the inanimate environment.[15]  Other regulations may regulate the movement of certain animals and articles that may carry disease and microbial organisms.[16]  FDA has invoked its authority under the PHS Act to take certain importation and quarantine measures and has issued the Produce Safety Rule and other regulations based in part on the PHS Act.  In one case, FDA’s use of the PHS Act to regulate small turtles that can spread communicable disease was upheld.[17] 

C. Other Agencies’ Limited Authorities

FSIS has jurisdictional authority under its authorities, including the Meat Inspection Act and the Poultry Inspection Act, at the point animals are brought to slaughter.[18]  Regulated meat processors are exempt from the FDCA.[19]  FSIS thus does not appear to have authority to conduct examinations or inspections of cattle ranches or other establishments in which animals are raised prior to the slaughter process.

Other agencies have some authority that is worth mentioning.  The Animal and Plant Health Inspection Service (APHIS) has certain regulatory authority related to animal agriculture.  APHIS has authority under the Animal Health Protection Act to take various measures that include entering facilities operating in interstate commerce.[20]  The statute under which APHIS operates does not appear to provide powers that would be effective in taking control measures for food safety threats related to animal agriculture, and, without evidence of interstate commerce, its authority to inspect relies upon a determination of the Secretary of Agriculture that “an extraordinary emergency exists because of the presence in the United States of a pest or disease of livestock and that the presence of the pest or disease threatens the livestock of the United States.”[21]  APHIS has agreed to support FSIS in conducting outbreak investigations,[22] but it is not apparent that APHIS could exercise authority to advance an investigation where animal health does not appear to be at issue.

Further, the Environmental Protection Agency (EPA) has authority over regulating the flow of manure from centralized animal feeding operations (CAFOs), but this authority is narrow.  The authority only applies to effluent pursuant to the Clean Water Act to establishments that are large, a category less than one fifth of the estimated 1.3 million animal agriculture establishments with livestock.[23]  EPA is focused on only the largest operations, and its effluent limitations only apply to the largest CAFOs, those which involve over one thousand animals in the case of cattle.[24]  Smaller CAFOs must apply for a permit, and the regulatory restrictions focus on effluent.[25]

D. FDA Currently Lacks Capacity for Regulating Animal Agriculture

Despite FDA’s technical jurisdiction over much of animal agriculture, it lacks capacity to take on the task of regulating it effectively.  FDA’s food program is already overburdened and under resourced even when compared to its sister agencies.  FDA has struggled to meet its food inspection mandates in the domestic sphere and has never had the capacity to conduct inspections of foreign facilities in the range contemplated by Congress when it passed the Food Safety Modernization Act.[26]  Further, FDA has very little experience dealing with this industry sector, and engaging with facilities that have not had experience with this type of oversight can further drain resources.  In the case of its potential exercise of jurisdiction over breeding stock, FDA would place itself in the challenging position of expending resources and taking action on products that would ultimately be regulated and overseen by FSIS.

III. Major Food Safety Issues Concerning Animal Agriculture

The relation between animal agriculture and food safety is central and thus deserves our focus.  Surveillance data indicates that the overall incidence of foodborne illness has remained constant despite significant regulatory efforts, most notably the Food Safety Modernization Act.[27]  Conclusions about a lack of progress are less than clear, for there have been increases in our technical ability to detect foodborne illnesses over the years and foodborne illness appears to be underreported.[28]  Nonetheless, the lack of apparent progress suggests that we should consider different ways to focus our efforts.  Focusing on the connection between animal agriculture and major food safety problems offers such an opportunity.

A. The Relation Between Animal Agriculture and Produce Safety

Produce is central to maintaining a healthy diet.  At the same time, produce has been a relatively risky category of foods from a food safety perspective.  FDA has jurisdiction over produce and found that produce outbreaks constitute a large share of outbreaks of foodborne illness investigated in recent years.  Between 1996 and 2010, produce accounted for more than forty-two percent of the total outbreak-related illnesses FDA investigated.[29]  This pattern appears to be continuing and perhaps even growing in more recent years.  For example, in 2024, FDA investigated twenty-six outbreaks of foodborne illness and identified the responsible food in twenty cases; produce accounted for fourteen of the twenty commodities—more than two-thirds of the outbreaks.  The same pattern appears over the last decade with interstate outbreaks of foodborne illness.[30] 

Animal waste has repeatedly been found to be the most likely causal factor in a significant number of large-scale produce outbreaks in recent years.  Agricultural water can serve as a vehicle for transmitting pathogens from a variety of locations, including those harboring animals, to produce fields.[31]  Further, air samples taken by FDA during a longitudinal study also preliminarily demonstrate that airborne dust can act as a transfer mechanism for pathogens from nearby land to water, soil, and produce.[32]

One of the most concerning links between animal agriculture and produce relates to the impact of Shiga toxin-producing Escherica coli (STEC).  In recent years, the country has been challenged by repeated outbreaks of leafy greens with STEC, including repeated outbreaks involving E. coli 0157:H7.  Between 2009 and 2021, FDA and its regulatory partners identified forty-nine STEC outbreaks linked to leafy greens.  FDA issued several advisories urging consumers to avoid romaine lettuce and other products during this time.[33]  FDA, state, and local regulatory officials traced an extremely large outbreak in 2018 to twenty-three farms in the Yuma growing region.  FDA’s investigation indicated that water samples taken from a canal between a large CAFO and implicated farms contained the outbreak strain; the investigation report does not reflect that FDA conducted any sampling at the CAFO itself.[34]  Subsequent large outbreaks occurred in the following years.  The romaine lettuce outbreaks involving STEC in those years alone have been involved in hundreds of illnesses and a significant number of deaths.[35]  The leadership of the foods program in FDA identified addressing these recurring outbreaks in leafy greens as one of the most urgent public health issues we face and has devoted substantial resources to addressing the issue.[36]

FDA responded to these outbreaks by taking a number of actions that execised its jurisdiction over produce.  FDA inspected produce farms, sampled produce, advanced a provision of the produce rule regulating  growers’ agricultural water, and supported education and tools for growers.  FDA’s investigational work uncovered farms implicated in outbreaks, which led to recalls and consumer advisories, and frequently identified the presence of cattle ranches or other animal agriculture as a potential hazard for many implicated farms.[37]  FDA’s extensive work did not include sampling, inspections, or oversight of animal agriculture facilities.

While FDA has identified livestock facilities as a potential hazard for produce farms to consider as part of their obligation to prevent contamination, the specific measures that would be effective are often unclear.  More understanding is needed to create reliable, effective measures to prevent contamination.  Reducing environmental contamination is complex.  The environment contains a large number of variables, and, despite sustained efforts, there are currently significant gaps in our understanding of the exact circumstances that give birth to these outbreaks.

B. Salmonella Enteriditis in Chickens through Breeding Stock

Another significant issue involving the potential impact of animal agriculture on food safety involves the breeding of chickens for food.  In the United States, breeding companies seek to produce chickens that grow quickly and yield meat.  Poultry farmers raise the birds they receive from breeding companies until the chickens are taken to a processing facility for slaughter.  This system operates on a large scale, processing over 9.3 billion chickens annually.  Nonetheless, only two breeding companies dominate the market nationwide.[38]

Despite the fact that chickens are consumed after cooking, chickens remain a leading source of foodborne illness.[39]  There is strong evidence that two of the most common and impactful pathogens responsible for outbreaks from chickens are often passed on to progeny from the infected ovaries of hens.[40]  Studies have shown that Salmonella and Campylobacter are frequently present when live chickens are received at processing plants, indicating that infection with these pathogens occurred before slaughter and not during the slaughtering process, although this too may occur.[41]  Genome sequencing conducted by FSIS involving a wide variety of geographical locations indicate that these pathogens typically can most likely be traced to breeding stock, for this can effectively explain how genetically closely-related and often indistinguishable pathogens can appear throughout the country at various facilities.  One researcher reviewed genomic data and concluded that the data establishes a causal relation between Salmonella Enteriditis and Campolybacter from breeding stock and that this relationship best explains the nature of outbreaks in this area.[42]

IV. Future Work in Animal Agriculture Holds Promise in Preventing Foodborne Illness

The first step in seeking to address a problem is to understand it, and data is needed to understand how hazards are likely to elevate risks to human health.  Pathogens exist in the farm environment, and, in order to understand the specific circumstances in which they can result in a risk to human health, a great deal of data is needed to arrive at statistically sound conclusions and effective preventive measures.  Regulatory oversight empowers agencies to gather data from establishments by sampling animal feces, soil, animal stock, or other materials that could be linked to virulent pathogens.  Federal agencies have not yet taken these steps to exercise jurisdiction over animal agriculture related to their food safety responsibilities. 

A. The Potential Use of Regulatory Jurisdiction to Gather and Analyze Data for Use in Preventative Measures

Today FDA, FSIS, and their regulatory partners have the ability to use whole genome sequencing (WGS) to reveal the complete DNA of an organism.  FDA and its partners use this technology to identify pathogens from food or environmental samples.  Most notably, this technology can match the DNA of pathogens from sick patients with those identified in a food or a facility, which can shorten an outbreak’s duration.  Indeed, this technology has been used in this way many times in the recent past.  It can also be used to determine which illnesses are part of an outbreak and which are not; which ingredient in a multi-ingredient food is responsible for an outbreak; geographic regions from which a contaminated ingredient may have originated; differentiation of contamination sources; and linkages between small numbers of illness.[43] 

WGS can identify how pathogens migrate and thereby allow us to uncover the root causes of food adulteration.  Sampling and analysis of water, soil, and manure at ranches and at other places animals are reared provide an opportunity to get clarity regarding the specific circumstances that have resulted in contamination.  When large data sets can be combined and analyzed, which artificial intelligence now has the increased capacity to do, more specific and meaningful guidance on preventative practice becomes possible.  This type of guidance is sorely needed.

The general picture is already apparent.  After foodborne illness outbreaks, FDA has repeatedly found links between implicated produce farms and animal agriculture on adjacent land.  FDA also generally refers to animal agriculture establishments near produce farms as a foreseeable hazard to produce safety, which requires produce farms to plan preventative controls. Similarly, in the case of chickens raised for human consumption, the fact that Salmonella Enteriditis (SE) can be passed down from breeding stock has long been understood as a major contributor of pathogen dissemination in poultry production systems across the world.[44]  Evidence involving SE and Campylobacter occurring in outbreaks in the United States demonstrate that the importance of this risk may be even greater than previously understood.[45]  In addition, it has long been understood that the predominant route through which eggs become contaminated with SE is the transovarian route, where SE infects the ovaries and oviducts of egg-laying hens, allowing transovarian contamination of the interior of the egg from laying hens.[46]  Rather than seeking to control SE in eggs through exercising jurisdiction over the breeding of laying hens, FDA focused on other preventative controls in issuing regulations related to shell eggs.[47] 

Although federal and state agencies and significant segments of the industry have all engaged in good-faith efforts to solve these problems,[48] the strategies employed have not proved sufficient.  With generalized concerns over environmental contamination, it is not clear when the level of risk should be considered so substantial that action needs to be taken, or, if so, the type of preventative measures that will most likely be effective.  Across the United States, animal agriculture and produce farms are near one another.  Where contamination occurs in the environment, it is difficult to isolate variables, and the virulence of different pathogen strains can vary as well.  A vast amount of data is needed to generate a clear understanding of the set of circumstances that will result in contamination and what can be done to provide effective prevention.  In the case of the contamination of poultry in the food supply, employing jurisdictional controls to identify and to exclude breeding stock prone to SE and Campylobacter contamination offers a path to reduce contamination.  Denmark and Sweden appear to have successfully pursued such a strategy in containing SE.[49]  The apparent comparative effectiveness of these measures suggests that the United States should explore the exercise of control measures earlier in the process.

B. Stakeholder Engagement Is Helpful and Not Sufficient

Where the exercise of government jurisdiction appears lacking, one question is whether the private sector is prepared to address the issue on its own.  Private entities can work together to share their data, and there have been significant efforts along these lines.[50]  It is in the interests of industry to take effective, tailored steps to prevent pathogens from reaching consumers, and to implement tools to identify the root cause of contamination to mitigate food safety problems quickly when they do arise.

Nonetheless, the short-term interests of producers in animal agriculture are not necessarily aligned with producing data about the incidence of pathogens in their livestock or on their own land.  Producers have ample reason to be cautious and concerned about potential adverse effects on their own business.  The greatest contributions to public health likely involve understanding the most virulent, dangerous pathogens, and, where data can credibly advance a hypothesis, businesses implicated in this chain of events may face the possibility of liability or reputational damage that could devastate their livelihoods.  While partnerships can be tremendously helpful in spreading education and awareness about effective prevention and challenges, the incentives are quite different where causation of harm is being examined in the real world. 

V. Conclusion: Finding a New Path Forward

Animal agriculture occurs in the United States at a large scale, involving billions of animals.  It has long been well-known that pathogens can travel from or through live animals to the food we eat.  Certain hazards in this process have been made clear in recent years, and it is likely that the use of genomic matching and artificial intelligence to analyze this data have the capacity to increase clarity about the issue. 

Despite many signals, we do not have a clear path that will allow the food safety community to look comprehensively across farms, ranches, and retailers to reach the root causes of foodborne illness.  This is regrettable because we now have the capacity with the use of large sets of data and computing power to better understand these issues, and understanding causation at a detailed level could prevent a great deal of illness and death, as well as reduce costs to producers who find themselves implicated in these issues. 

There are some measures that industry stakeholders could take.  Breeding lines that have been implicated in contamination could be excluded, as Denmark and Sweden have done.  Farmers and ranchers in the same area share an interest in understanding how contamination is likely to happen and to take control measures where possible to prevent such circumstances.   

Results could be meaningfully advanced by providing an agency with the power and capacity to examine these issues robustly.  Leadership in understanding and addressing this issue is needed.  Jurisdiction to investigate and to address the roots of foodborne illness in food-producing animals is fragmented at best.  APHIS does not appear to have jurisdiction where animal health has not been implicated, EPA has jurisdiction that is limited to effluent discharges from certain animal feeding operations, and FSIS has jurisdiction over the slaughtering process and the resulting products.  FDA has a potential jurisdictional claim, though it lacks capacity.  In the interim, FDA could seek to advance a jurisdictional claim and sample on ranches near growing locations that are implicated in outbreaks where contamination from animal waste is a plausible cause.  To take on these issues in a more comprehensive way, without transferring jurisdiction or creating a new agency, FDA’s funding and orientation would need to change.  Alternatively, Congress could redraw jurisdictional lines and funding so that a single food safety agency or another existing agency would have the capacity and the jurisdiction to address this issue.

Currently, the government has effectively cut funding for food safety, lost staff that cannot be replaced in the near future, and struggled to meet existing responsibilities.  Given this circumstance, it might seem odd to focus on an area that requires additional data and focus beyond what has been done before.  Yet it is precisely when systems are going to be rebuilt where there are opportunities to restructure areas of focus.  Focusing on this area holds promise in bending the curve of foodborne illness in the future.  

[1] The concept of “One Health” is an approach that recognizes that there are connections between human health, animal health, and environmental conditions.  See generally U.S. Centers for Disease Control and Prevention, About One Health (June 27, 2025), https://www.cdc.gov/one-health/about/index.html. 

[2] U.S. Government Accountability Office, Food Safety: Status of Foodborne Illness in the United States, GAO-25-107606, at 1 (February 3, 2025), https://www.gao.gov/products/gao-25-107606.

[3] See 21 U.S.C. § 374(a)(1) (providing authority for inspection and sampling of food held for sale in interstate commerce).

[4] 21 U.S.C. §§ 321(f)(1) and (3).

[5] See Nutrilab v. Schweiker, 713 F.2d 335 (7^th Cir. 1983).

[6] U.S. Food and Drug Administration, Post-Approval Monitoring of Animal Drugs, Feeds and Devices, Illegal Residues in Meat, Poultry, Seafood, and Other Animal Derived Foods, COMPLIANCE PROGRAM MANUAL, Program 7371.006 at 28 (April 7, 2023), https://www.fda.gov/media/74810/download.  See also U.S. Food and Drug Administration, Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Guidance for Industry (March 2018), https://www.fda.gov/media/112085/download (stating that live animals imported for food are subject to FDA jurisdiction).

[7] See, e.g., United States v. Tuente Livestock, 888 F. Supp. 1416 (S.D. Ohio 1995) (holding FDA may interpret the term “food” to “include live animals raised for food”); United States v. Tomahara Enterprises Ltd., FOOD DRUG COSM. L. REP. (CCH) 38,217 (N.D.N.Y. 1983) (finding live calves intended as veal are food). 

[8] Program 7371.006 at 28. 

[9] United States v. Bacto-Unidisk, 394 U.S. 784, 798 (1969) (finding a product to be a “drug” requiring FDA clearance despite district court’s determination that such an application would be “ridiculous and contrary to common sense.”) 

[10] Id. 

[11] See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (finding tobacco outside FDA jurisdiction because such an application violated a core objective of the Act that products be safe and effective and because Congress had explicitly rejected the application of FDA jurisdiction to tobacco in the past).  

[12] See New York v. Burger, 482 U.S. 691 (1987).

[13] See 42 U.S.C. § 264. 

[14] See 21 C.F.R. § 1240.30 (providing that where “the Commissioner of Food and Drugs determines that the measures taken by health authorities of any State or possession . . . are insufficient to prevent the spread of any of the communicable diseases from such State or possession to any other State or possession, he may take such measures to prevent such spread of the diseases as he deems reasonably necessary, including inspection”).

[15] 21 C.F.R. § 1240.3(b). 

[16] See, e.g., 21 C.F.R. §§ 1240.60, 1240.65, and 1240.61.

[17] See State of Louisiana v Mathews, 427 F. Supp. 174 (1977).

[18] See, e.g., 21 U.S.C. § 603(a) (providing for “examination and inspection of covered species before they shall be allowed to enter at any slaughter, packing, meat-canning, rendering or any similar establishment” and “when so slaughtered the carcasses”) and 21 U.S.C. § 455 (providing for inspection of poultry and poultry products in covered establishments).

[19] 21 U.S.C. § 392(a).

[20] See 7 U.S.C. § 8307.

[21] 7 U.S.C. § 8306.

[22] See Memorandum of Understanding Between the Food Safety and Inspection Service and the United States Department of Agriculture Animal and Plant Health Inspection Service Veterinary Services (April 2014), https://www.fsis.usda.gov/sites/default/files/media_file/2020-11/MOU-FSIS-APHIS-One-Health.pdf.

[23] National Pollutant Discharge Elimination System Permit Regulation and Effluent Limitation Guidelines and Standards for Centralized Animal Feeding Operations,”68 Fed. Reg. 7176, 7179 (Feb. 12, 2003).

[24] Id. at 7181.  See also 40 C.F.R. § 122.23.

[25] See 40 C.F.R. § 122.23.

[26] U.S. Government Accountability Office, Food Safety: FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply (Jan. 8, 2025), https://www.gao.gov/products/gao-25-107571.

[27] U.S. Centers for Disease Control and Prevention, Pathogen Surveillance, https://wwwn.cdc.gov/foodnetfast/. 

[28] U.S. Government Accountability Office, Food Safety: Status of Foodborne Illness in the U.S., GAO 25-107606 (Feb. 25, 2025), https://www.gao.gov/assets/gao-25-107606.pdf.

[29] Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, 78 Fed. Reg. 3504, 3507 (January 16, 2013).

[30] See U.S. Food and Drug Administration, Investigations of Foodborne Outbreaks, https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks. 

[31] See, e.g., U.S. Centers for Disease Prevention and Control, Shiga Toxin-Producing Escherichia coli 0157:H7 Illness Associated with Untreated, Pressurized Municipal Irrigation Water – Utah, 2023, MORBIDITY AND MORTALITY WEEKLY REPORT (May 9, 2024), https://www.cdc.gov/mmwr/volumes/73/wr/pdfs/mm7318a1-H.pdf, (noting that microbial source tracking identified animals as potential sources of fecal contamination of municipal water).

[32] Stelio Viazis et al., An Overview of Farm Investigation Findings Associated with Outbreaks of Shiga Toxin-Producing Escherichia coli Infections Linked to Leafy Greens: 2009-2021, J. FOOD PROT. 88(7) (June 23, 2025).

[33] Id.

[34] U.S. Food and Drug Administration, Environmental Assessment of Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in Multi-State Outbreak of E. coli 0157:H7 (November 1, 2018), https://www.fda.gov/food/outbreaks-foodborne-illness/environmental-assessment-factors-potentially-contributing-contamination-romaine-lettuce-implicated.

[35] Stelio Viazis et al., An Overview of Farm Investigation Findings Associated with Outbreaks of Shiga Toxin-Producing Escherichia coli Infections Linked to Leafy Greens: 2009-2021.

[36] See, e.g., U.S. Food and Drug Administration, Leafy Greens STEC Action Plan, https://www.fda.gov/food/foodborne-pathogens/leafy-greens-stec-action-plan.  Leafy greens are also not the only affected product, for outbreaks of pathogenic E. coli have included other products.

[37] See, U.S. Food and Drug Administration, Adjacent and Nearby Land Use and its Impact on Produce Safety, https://www.fda.gov/food/food-safety-modernization-act-fsma/adjacent-and-nearby-land-use-and-its-impact-produce-safety. 

[38] David J. Lipman, Genomic Epidemiology of Salmonella and Campylobacter in Poultry Production: Quantifying the Contribution of Primary Breeders, MEDRXIV (November 13, 2025), https://www.medrxiv.org/content/10.1101/2025.11.11.25340000v1.full-text.

[39] S.J. Chai, et al., Poultry: the most common food in outbreaks with known pathogens, United States, 1998–2012, 145 EPIDEMIOLOGY AND INFECTION 316-25 (Oct. 26, 2016), https://pmc.ncbi.nlm.nih.gov/articles/PMC9507623/.

[40] Lipman, Genomic Epidemiology of Salmonella and Campylobacter in Poultry Production: Quantifying the Contribution of Primary Breeders.

[41] See, e.g., Daniela R. Chavez-Velado, et al., Daniela R., David A. Vargas, and Marcos X. Sanchez-Plata, Bio-Mapping Salmonella and Campylobacter Loads in Three Commercial Broiler Processing Facilities in the United States to Identify Strategic Intervention Points, 13 FOODS (January 5, 2024), https://pubmed.ncbi.nlm.nih.gov/38254481/; J. Wang, et al., A systematic review and meta-analysis of the sources of Campylobacter in poultry production (preharvest) and their relative contributions to the microbial risk of poultry meat, 102 POULTRY SCIENCE (Oct. 2023), https://pubmed.ncbi.nlm.nih.gov/37516002/.

[42] Lipman, Genomic Epidemiology of Salmonella and Campylobacter in Poultry Production: Quantifying the Contribution of Primary Breeders.

[43] See U.S. Food and Drug Administration, Whole Genome Sequencing (WGS) Program, https://www.fda.gov/food/microbiology-research-food/whole-genome-sequencing-wgs-program

[44] Shaoting Li, et al., Global Spread of Salmonella Enteriditis via Centralized Sourcing and International Trade of Poultry Breeding Stocks, 12 NATURE COMMUNICATIONS 5109 (August 25, 2021), https://www.nature.com/articles/s41467-021-25319-7.

[45] Lipman, Genomic Epidemiology of Salmonella and Campylobacter in Poultry Production: Quantifying the Contribution of Primary Breeders.

[46] Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, 74 Fed. Reg. 33030 at section I(C) (July 9, 2009), https://www.federalregister.gov/documents/2009/07/09/E9-16119/prevention-of-salmonella-enteritidis-in-shell-eggs-during-production-storage-and-transportation (stating that while environmental contamination is still a route for Salmonella contamination, SE experts now believe that the predominant route through which eggs become contaminated with SE is the transovarian route”).

[47] Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, 78 Fed. Reg. 3504 (January 16, 2013).

[48] See, e.g., U.S. Food and Drug Administration, Leafy Greens STEC Action Plan.

[49] See, e.g., Henrik C. Wegener, et al., Salmonella Control Programs in Denmark, 9 EMERGING INFECTIOUS DISEASES at 774-80 (July 2003), https://wwwnc.cdc.gov/eid/article/9/7/03-0024_article; M. Wierup,  M., et al., Control of Salmonella Enteritidis in Sweden, 25 INTERNATIONAL JOURNAL OF FOOD MICROBIOLOGY at 219-26 (May 1995), https://pubmed.ncbi.nlm.nih.gov/7654509/; Tanya Roberts and Johan Lindblad, Sweden Led Salmonella Control in Broilers: Which Countries Are Following?, FOOD SAFETY ECONOMICS at 231-49 (December 22, 2018), https://link.springer.com/chapter/10.1007/978-3-319-92138-9_12. 

[50] See, e.g., Cal. Dept. of Food and Agriculture, et al., California Agricultural Neighbors (Fall 2024), https://www.cdfa.ca.gov/is/docs/CAN_Report_Building_a_Proactive_Food_Safety_Culture.pdf 

 

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