Colorado Environmental Law Journal > Printed > Volume 34 > Issue 1 > Federal Insecticide, Fungicide, and Rodenticide Act Preemption of State Failure-to-Warn Laws

Federal Insecticide, Fungicide, and Rodenticide Act Preemption of State Failure-to-Warn Laws

Table of Contents

Introduction

I. Background

A. Pesticide Overview

B. Monsanto

C. Implications for Victims and Pesticide Manufacturers

II. Preemption

A. FIFRA Label Requirements

B. Bates v. Dow Agrosciences LLC

III. Limits of FIFRA Preemption

A. Express Preemption

1. Imposes a Requirement

2. For Labeling or Packaging

3. In Addition To or Different From

4. Takeaways for Express Preemption

B. Implied Preemption

1. Is Implied Preemption Precluded?

2. Impossibility Preemption

3. Registration as a Defense

4. Takeaways from Implied Preemption

IV. The Future of FIFRA Preemption

A. Hardeman v. Monsanto Analysis

B. The Role of the EPA

C. Future Litigation

Conclusion 100

Introduction

Pesticides, while an important component of the United States agricultural industry, can and do cause harmful health effects. Recently, there have been thousands of lawsuits brought against pesticide manufacturers, alleging that the chemicals in some pesticides have caused various negative health impacts. Many of these lawsuits involve state tort law claims that the pesticide label failed to warn of a certain harm.[2] These laws are important with respect to pesticide-caused harms because there is no relief available under federal law.

The Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) provides that states “shall not impose . . . requirements for labeling or packaging in addition to or different from those required [by FIFRA].”[3] Put differently, state labeling laws are preempted if they impose requirements in addition to or different from those in FIFRA. The Supreme Court of the United States has interpreted this provision to mean that states may independently penalize offenses currently outlined by FIFRA but may not create additional or different offenses under state law.[4]

FIFRA clearly states that a state labeling law is not preempted if it simply restates the wording of FIFRA and imposes state-specific penalties. FIFRA also makes clear that a state labeling law is preempted if it requires extra items on a label that FIFRA does not require. Such a framework allowing individual states to impose distinct labeling requirements would cause chaos for manufacturers and consumers alike. However, a complicated situation arises when a law is on its face equivalent to FIFRA but imposes a requirement that the United States Environmental Protection Agency (“EPA”), FIFRA’s implementing agency, says is unlawful.

That was the situation in Hardeman v. Monsanto, where Monsanto sought a judgment that California’s common law duty to warn was preempted by FIFRA.[5] The Ninth Circuit ruled that the California law was not preempted, and the Supreme Court denied Monsanto’s petition for review, presumably because there was no circuit split.[6] The Supreme Court’s denial has major implications for Monsanto because, according to the Ninth Circuit, Hardeman was a “bellwether trial with potentially thousands of federal cases to follow.”[7] Hardeman also has major implications for those negatively impacted by the pesticide Roundup. For those victims, failure-to-warn claims brought under state law are one of the only avenues for relief. Hardeman was only the initial attempt by Monsanto to get a favorable ruling in federal court, and it certainly won’t be the last.

This Note explores the limits of FIFRA’s preemption of state labeling laws by examining how broadly a plaintiff’s ability to bring state law failure-to-warn claims extends. Ultimately, the current FIFRA preemption framework is robust enough to handle various cases and should be affirmed by the Supreme Court in the future. Section I provides background information about pesticide registration, Roundup and Monsanto, and the legal relief available to victims. Section II surveys preemption generally and preemption principles specific to pesticide litigation. Section III explores the limits of FIFRA’s preemption of state laws, using case law as guide. Finally, Section IV analyzes the unique situation that Hardeman raised, the role of the EPA in pesticide safety determinations, and the implications of the Court deciding to take up a similar case in the future.

I. Background

A. Pesticide Overview

A pesticide, in the broadest sense of the word, “is any substance used to kill, repel, or control . . . plant[s] or animal[s] . . . that are considered to be pests.”[8] This includes herbicides, insecticides, fungicides, and rodenticides.[9] The agricultural sector accounts for approximately ninety percent of pesticides used, by weight, in the United States.[10] Pesticides are used in agriculture to increase crop yields by killing competing plants and predatory animals. And there is a pressing need: the Food and Agricultural Organization of the United Nations estimates that between twenty to forty percent of global crop production is lost to pests annually.[11] That is an alarming amount of food loss considering that 9.9% of the world population was undernourished in 2020.[12] Pesticides can help mitigate this loss. The United States Department of Agriculture determined that pesticides contributed to a substantial increase in crop yields between 1930 and the 2000s.[13] For example, average corn yields increased from twenty bushels per acre in 1930 to more than 150 bushels per acre in the 2000s.[14]

However, there are health risks associated with pesticide use, both from acute toxicity and from chronic toxicity.[15] Acute toxicity refers to a chemical’s ability to cause injury from a single exposure. Acute effects include coughing, dermatitis, nausea, vomiting, and even death.[16] Chronic toxicity describes harmful effects that occur from repeated exposure to small doses over a period of time.[17] Chronic effects from pesticide exposure include production of tumors, blood disorders, nerve disorders, endocrine disruption, reproductive harm, and cancer.[18] Both acute and chronic effects are endured mainly by vulnerable populations—namely, farm workers, pregnant women, children, and older adults.[19]

To protect against the dangers presented by pesticides, Congress passed the first version of FIFRA in 1947.[20] Under FIFRA, the EPA regulates the distribution, sale, and use of pesticides within the United States.[21] To gain approval to sell a pesticide, a manufacturer must register the pesticide by showing, among other things, that the pesticide “will not generally cause unreasonable adverse effects on the environment.”[22] The EPA reviews all of the scientific data on the pesticide and develops risk assessments that examine the effects of the pesticide on the human population and the environment.[23] Based on these effects, the EPA either approves or denies the registration of the pesticide. If approved, the EPA determines the proper application rate and application method and creates a label with use instructions.[24] The intent of the label is to provide clear directions for optimum pesticide performance while minimizing the risks to human health and the environment.[25]

In practice, EPA’s evaluation process provides pesticide manufacturers with a less rigorous procedure for registering a new pesticide than what might have been envisioned by Congress. Under the normal procedure, pesticide manufacturers must submit studies regarding the pesticide’s effects on human health, wildlife, and the environment. However, a loophole called conditional registration exists that allows pesticide approval without all necessary data.[26] The EPA intended to use conditional registration for new products that have not yet generated enough health impact data, so long as conditional approval is in the public interest.[27] The EPA frequently uses this process. By one estimate, as of 2010, sixty-five percent of all active pesticide products are conditionally approved.[28] Although the EPA claims that between 2004 and 2010 it did not alter its approval decision based on subsequent data, it remains unknown whether the EPA received necessary data and whether the EPA’s conclusions were well-founded.[29] This leaves thousands of pesticides available for use despite potentially inadequate screening.[30]

Also, there are concerns about bias within the EPA office based on whistleblower accounts.[31] For example, according to an EPA toxicologist, a 2018 review of the toxicology data on pelargonic acid showed that several mice developed leukemia and lymphoma after the chemical was applied to their skin.[32] These results stood in stark contrast with the 1997 review of the same chemical, which showed that it posed no health risks.[33] The toxicologist first showed these results to various managers and colleagues, and they individually agreed that there was cause for concern.[34] However, when the toxicologist presented the findings to a group of managers in the pesticide office and told them that pelargonic acid is a key ingredient in Roundup, the managers “pulled back,” and even retaliated against the toxicologist.[35]

Pesticides are an important tool for agriculture, but we must use them with care due to their potentially harmful effects. FIFRA implements procedures to register pesticides only when they are found to have no harmful effect on humans or the environment. However, the conditional registration loophole can lead to underinformed approvals, and officials in the EPA may even ignore adverse data if present, especially if the data impacts major pesticide manufacturers.

B. Monsanto

Roundup is an herbicide produced by the Monsanto company.[36] Its main active ingredient is glyphosate.[37] Although Monsanto previously held patent rights to glyphosate, it is now off-patent and is produced by most major agrochemical manufacturers.[38] It is estimated that glyphosate sales account for around $8 billion of an $80.3 billion global pesticide industry.[39] Glyphosate was first approved by the EPA in 1974, and continues to get reapproved, most recently in 2020.[40]

EPA’s reapproval of glyphosate included a finding that glyphosate does not pose any human health concerns.[41] The EPA made this decision despite studies showing glyphosate’s possible cancerous effects.[42] The most significant study is the International Agency for Research on Cancer glyphosate study of 2015, which concluded that glyphosate is “probably carcinogenic to humans.”[43] Despite the EPA’s conclusion that glyphosate is safe, there have been thousands of successful legal claims against Monsanto claiming that glyphosate caused a number of health issues, including cancer. Most notably, Monsanto paid over $10 billion to settle a class action suit involving around 95,000 claims that glyphosate caused the claimants’ non-Hodgkin’s Lymphoma.[44]

One recent case that will be discussed throughout this Note is that of Edwin Hardeman.[45] Hardeman, a California resident, frequently sprayed Roundup around his property to control poison oak for nearly three decades.[46] It never occurred to Hardeman that Roundup could be harmful, because it was so widely used and there was no warning label.[47] In late 2014, Hardeman discovered a swollen lymph node on his neck, and was later diagnosed with non-Hodgkin’s Lymphoma.[48]

Hardeman brought suit in federal court against Monsanto in 2016, alleging that Monsanto’s failure to warn of the risk of cancer led to Hardeman’s non-Hodgkin’s Lymphoma.[49] Hardeman’s case was consolidated along with 6811 other plaintiffs, all who made similar product liability claims against Monsanto.[50] Hardeman’s case was the first to go to trial, and the jury awarded him approximately $5 million in compensatory damages and $75 million in punitive damages.[51] Monsanto appealed to the Ninth Circuit, which affirmed the district court ruling, holding that the failure-to-warn laws were not preempted by FIFRA.[52] Monsanto filed a writ for certiorari with the United States Supreme Court, which was ultimately denied.[53] Although Supreme Court review was denied in this case, there is the potential for a similar case arising once a circuit split has been established.[54]

C. Implications for Victims and Pesticide Manufacturers

The consequences of a future Supreme Court ruling in a case similar to Hardeman are high for both victims and pesticide manufacturers, like Monsanto.

Victims of pesticide harm have few options for legal relief. Although advocacy groups can sue the EPA to petition for a review of pesticide approval, these suits may not include any form of relief for victims.[55] Those lawsuits provide proactive protections, but they do not provide compensation to those already harmed.

Such compensation comes from tort suits filed under state law. Tort suits are generally brought against the manufacturer of the pesticide, and include negligence and/or product liability claims.[56] Critically, FIFRA does not provide a federal remedy for those injured by pesticides, so state law tort suits are a victim’s only avenue for relief.[57] Because there are few options for legal relief available to pesticide victims, Monsanto’s continued argument that FIFRA preempts state law could negatively impact pesticide victims’ ability to gain relief under state failure-to-warn claims. Thus, victims of pesticide exposure have a high interest in maintaining the status quo.

Pesticide manufacturers like Monsanto have a high monetary incentive to prevent victims from bringing state law claims. Since the first jury verdict against Monsanto in 2018,[58] the stock of Bayer, Monsanto’s parent company, immediately dropped and has not since recovered.[59] The lawsuits have induced Monsanto to discontinue using glyphosate in its lawn and garden products by 2023.[60] It is undoubtedly in Monsanto’s best interest to make sure victims cannot bring these suits.

At any rate, the Hardeman case is a “bellwether trial” with many more federal cases to follow.[61] The case is a bellwether because it determined that similarly harmed plaintiffs could successfully sue Monsanto in federal court, in part because FIFRA did not preempt the underlying state labeling law.[62] Although Hardeman will not be reviewed by the Supreme Court, winning a similar case at the Supreme Court is critical for Monsanto, as it is the first step of Monsanto’s “Five-Point Plan to Close the Roundup Litigation.”[63] The basis of a challenge in a case like Hardeman is that FIFRA preempts state failure-to-warn laws.[64]

Because preemption will be at issue in any future FIFRA litigation under a state failure-to-warn law, pesticide manufacturers and victims have a stake in how the Supreme Court will eventually decide. What follows is an overview of preemption, and then an analysis of the current state of FIFRA preemption law.

II. Preemption

Congress’s authority to preempt state laws is a fundamental principle of constitutional law.[65] Generally, courts assume that a federal law does not preempt state law unless Congress has made such an intention “clear and manifest.”[66] For preemption analysis, the “purpose of Congress is the ultimate touchstone.”[67] Federal courts have identified three means by which Congress adequately signals its intent to preempt state law: (1) Express preemption, where federal law expressly preempts state law through statute;[68] (2) implied preemption, either where it is impossible to comply with both state and federal law,[69] or when the state law frustrates the purposes and objectives of Congress;[70] or (3) field preemption, where the federal regulation scheme is so pervasive that Congress intended no state supplementation.[71]

For FIFRA, express preemption exists. FIFRA contains a label uniformity provision that says a “State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this chapter.”[72] This is FIFRA’s express preemption clause. It essentially states that when a label is deemed FIFRA compliant, states cannot implement additional labeling laws, and they cannot impose labeling requirements different from FIFRA’s.

FIFRA may also implicate implied preemption. Because FIFRA labeling requirements must be met exactly, it is arguably impossible to simultaneously comply with those requirements and state product liability laws, which can also impose a labeling requirement beyond those approved by the EPA.[73]

Field preemption is not at issue in pesticide regulation. FIFRA contains a provision that grants authority to states to regulate the sale or use of any federally registered pesticide in the state.[74] States have exercised this authority by implementing supplemental pesticide laws, not related to labeling, that are stricter than federal laws.[75] Because Congress intended to include states in pesticide regulation, state laws are not field preempted.

Before analyzing the current state of FIFRA preemption, it will be helpful to explore the labeling requirements under FIFRA and to examine the most recent Supreme Court ruling on this issue.

A. FIFRA Label Requirements

When FIFRA mandates that no state law shall impose requirements for labeling in addition to or different from FIFRA’s, what are the labeling requirements? This question is best answered through a series of more targeted inquiries.

First, what is a label? Under FIFRA, a label “means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.”[76] “Labeling” is “all other written, printed, or graphic matter– (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device.”[77] The label is intended to provide information about how to avoid harm to human health and the environment.[78]

Next, what does FIFRA prohibit with respect to the label? Under FIFRA, it is unlawful to sell “any pesticide which is adulterated or misbranded.”[79] FIFRA’s definitions subchapter contains instances where a pesticide is misbranded.[80] Some instances are intuitive where, for example, the label contains a false or misleading statement.[81] Others are less intuitive. For example, a pesticide is misbranded if “the label does not contain a warning or caution statement which may be necessary and if complied with, together with any requirements imposed under section 136a(d) of this title, is adequate to protect health and environment.”[82]

Finally, what must the manufacturer do to comply? FIFRA labeling requirements essentially impose an affirmative duty to include warnings necessary to protect human health, even if based on new information.[83] If a company does not update the label in light of some information indicating that the pesticide can cause adverse health impacts, the pesticide is “misbranded” in violation of FIFRA. The affirmative duty is explicitly articulated in FIFRA: “If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the Administrator.”[84]

According to EPA regulations, there are three different signal words that manufacturers must place on the label of every pesticide, depending on the toxicity level.[85] The “human hazard, precautionary statements, and human personal protective equipment statements are based upon the Toxicity Category of the pesticide.”[86] Therefore, the toxicity level, and warning label associated, are important for protecting the health of the user. There are four levels of toxicity; the lower the level, the more toxic.[87] Each toxicity level receives a signal word: (1) Toxicity category I must bear the signal word “DANGER,” and if its category is based on oral, inhalation, or dermal toxicity, it must bear the word “Poison”; (2) toxicity category II must bear the word “WARNING”; (3) toxicity category III must bear the word “CAUTION”; and (4) toxicity category IV needs no signal word.[88] FIFRA does not have an explicit requirement to warn about the risk of cancer, but some states, like California, do require a cancer warning before exposing consumers to a product known to cause cancer.[89]

B. Bates v. Dow Agrosciences LLC

The seminal case for FIFRA preemption is the 2005 Supreme Court case Bates v. Dow Agrosciences LLC.[90] In Bates, a group of twenty-nine Texan peanut farmers sent a letter to Dow Agrosciences threatening to sue for damage to the farmers’ peanut crop by Dow’s “Strongarm” pesticide.[91] According to the farmers, Dow knew, or should have known, that the pesticide would stunt the growth of peanuts in the Texan soil conditions, and that it was nevertheless marketed for all soil conditions.[92] Dow brought suit in federal court, seeking a declaratory judgment that FIFRA preempts the farmers’ state law claims.[93] The farmers counterclaimed for failure to warn, among other counterclaims.[94] The district court ruled in favor of Dow, and the Fifth Circuit affirmed.[95] The farmers appealed to the Supreme Court, the issue on appeal being whether FIFRA preempted the Texas failure-to-warn law.[96]

The Supreme Court vacated the lower court decision and implemented a state-claim-friendly framework for FIFRA preemption analysis.[97] In interpreting FIFRA, the Court established two requirements for a state law to be preempted: (1) the law must be a requirement “for labeling or packaging”; and (2) the law “must impose a labeling or packaging requirement that is ‘in addition to or different from those required under [FIFRA].’”[98] The first element of the preemption analysis “reaches beyond positive enactments, such as statutes and regulations, to embrace common-law duties.”[99] For the second element, “a state-law labeling requirement is not pre-empted by § 136v(b) if it is equivalent to, and fully consistent with, FIFRA’s misbranding provisions.”[100]

The Court reasoned that state laws that enforce federal misbranding requirements “aid, rather than hinder, the functioning of FIFRA.”[101] It recognized that pesticide labels are meant to evolve over time, and that state court actions may help expose new dangers associated with pesticides.[102] This would, in turn, lead manufacturers to petition the EPA to update labels for their products.[103]

The Court remanded the case to determine whether the Texas failure-to-warn law was preempted under the stated framework.[104] This case gave states broad authority to sanction manufacturers within the confines of FIFRA. In fact, the Court found that the “long history of tort litigation against manufacturers of poisonous substances adds force to the basic presumption against pre-emption. If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly.”[105]

Bates established a framework for preemption analysis that is slow to find preemption of state labeling laws. Subsequent cases from lower courts have largely adhered to the broad Bates holding, but there are exceptions. The next Section will more deeply examine how lower courts have ruled since Bates, and it will explore the limits of state law preemption.

III. Limits of FIFRA Preemption

A. Express Preemption

As discussed above, under FIFRA, a “State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.”[106] Although the Bates Court identifies two elements to the preemption analysis,[107] this Note will discuss three elements since courts analyze three in practice. A state law is preempted if it (1) imposes a requirement (2) for labeling or packaging (3) in addition to or different from those required under FIFRA.

1. Imposes a Requirement

Courts will first look at whether the state law imposed a requirement on the manufacturer. A “requirement” is most broadly understood as an imperative imposed on parties under the rule of law.[108] The Court recognized that, under FIFRA, a requirement goes beyond statutes and regulations to include common law duties.[109] Thus, when state common law imposes duties on manufacturers, those laws are requirements under FIFRA. However, an occurrence that merely motivates or induces a manufacturer to change the label at its option is not a requirement.[110] For example, a jury verdict that motivates a manufacturer to change its label is not a requirement.

The line between what is and is not a requirement under FIFRA is clear, so this portion of the analysis is not heavily litigated. However, the question of whether a requirement is for labeling or packaging is more contentious.

2. For Labeling or Packaging

Assuming that the state law imposes a requirement, the requirement must be for labeling or packaging. This qualifier limits the state law claims that are eligible for preemption. In Bates, the Court ruled that petitioners’ claims for defective design, defective manufacture, negligent testing, and breach of express warranty were not preempted because these are not requirements for labeling or packaging.[111] Rather, they require a safely designed product, defect-free, which has been properly tested, and whose warranty will be honored. Because “[n]one of these common-law rules require[] that manufacturers label or package their products in any particular way,” they are not requirements for labeling or packaging.[112] Courts have strictly interpreted this phrasing.

Not all sales and marketing materials are considered labeling.[113] However, a manufacturer’s website may be considered labeling if “the representations on the website are consistent with the label.”[114] Also, a state law requirement is not for labeling or packaging if it simply requires the content of the packaging to comply with the label.[115] Similarly, a state law related to pesticide use is not a requirement for labeling or packaging, even if the state law mandates a use contrary to the label’s instructions.[116]

Thus, courts are strictly reading the phrase “for labeling or packaging,” pursuant to the strict interpretation from Bates. Any laws arguably related to the label are not “for labeling or packaging” unless the law requires the manufacturer to “label or package their product[] in [a] particular way.”[117] Critically, courts will find design defects, manufacturing defects, and breaches of warranty not preempted in the first instance because the laws do not relate to the labeling or packaging.[118]

3. In Addition To or Different From

Once a court establishes that the law is a requirement for labeling or packaging, it must determine whether the requirement is in addition to or different from the requirements set forth in FIFRA. If the requirements of a state law impose requirements that are in addition to or different from FIFRA’s requirements, the state law may be preempted. For failure-to-warn laws, the addition to or different from question is the most important because failure-to-warn laws inherently “qualify as ‘requirements for labeling or packaging.’”[119]

The Court in Bates adopted a “parallel requirements” reading of Section 136(b), whereby a state labeling requirement is not preempted if it is “equivalent to, and fully consistent with, FIFRA’s misbranding provisions.”[120] A state law imposes parallel requirements if a violation of state law is also a violation of FIFRA.[121] In other words, when an action by a manufacturer violates both FIFRA and state law for the same reason, the state law imposes a requirement that is parallel to FIFRA.

As a threshold matter, a state law does not need to incorporate FIFRA’s requirements as an element to survive preemption,[122] and a state law need not use the same language as FIFRA.[123] However, the state law labeling requirement must be equivalent in fact to a FIFRA requirement.[124] The state law must also comply with relevant EPA regulations that give context to FIFRA provisions.[125]

Most simply, a state law is parallel to FIFRA if the wording is the same or similar. For example, in Southern Agricultural Insecticides, Inc. v. Taylor, the Oregon Pesticide Control Act prohibited “false or misleading” labels and FIFRA prohibited the same.[126] Because the FIFRA provision is identical, the court ruled that the two laws impose parallel requirements.[127] Also, in Blitz v. Monsanto Company, the Wisconsin Deceptive Trade Practices Act prohibited “untrue, deceptive or misleading representations” and FIFRA prohibited “false or misleading” representations.[128] The court ruled that because the phrases are linguistically similar, the requirements are equivalent.[129]

Similarly, a state law is not preempted if it contains qualifiers that narrow the scope of the state law relative to FIFRA. For example, in Beyond Pesticides v. Monsanto Co., advocacy group Beyond Pesticides sued Monsanto for false advertising under the District of Columbia Consumer Protection Procedures Act.[130] The Act makes it unlawful to “represent that goods . . . have . . . characteristics, ingredients, uses, benefits, or quantities that they do not have,” “misrepresent as to a material fact which has a tendency to mislead,” or “fail to state a material fact if such failure tends to mislead.”[131] FIFRA prohibits “any statement . . . which is false or misleading in any particular.”[132] The court ruled that the Act is “fully consistent” with FIFRA, in part because the scope is narrower due to qualifiers such as materiality.[133]

However, a law is preempted if it imposes a broader obligation than FIFRA’s requirement. For example, in DJ Coleman, Inc. v. Nufarm Americas, Inc., the plaintiff sued pesticide manufacturer Nufarm for fraudulent advertising claims under the North Dakota Consumer Fraud Act.[134] After the plaintiff used the Nufarm product, Assert, on his sunflower crop, the plants produced stunted and deformed heads.[135] Nufarm had included on its website that Assert is safe to use on sunflowers.[136] The North Dakota District Court ruled that the fraudulent advertising claim was preempted by FIFRA.[137] Whereas FIFRA simply requires that labels not contain false or misleading statements, the North Dakota Consumer Fraud Act included “any deceptive act or practice, fraud, false pretense, false promise, or misrepresentation.”[138] Because the North Dakota law imposed a broader obligation than FIFRA, the North Dakota law was not equivalent and was therefore preempted.[139]

For failure-to-warn claims, courts that found no preemption have favored a narrow interpretation of the “in addition to or different from” language in Bates.[140] For example, in Indian Brand Farms, Inc. v. Novartis Crop Protection Inc., plaintiffs brought a claim that Novartis should have warned of dangers of mixing the pesticide AG600 with certain fungicides.[141] The New Jersey law in question “imposes liability on a manufacturer where ‘the product causing the harm was not reasonably fit, suitable or safe for its intended purpose because it . . . failed to contain adequate warnings or instructions.’”[142] FIFRA requires a “warning or caution statement which may be necessary . . . to protect health and the environment.”[143] The court held that the state law was not preempted because it does not “impose a duty inconsistent with or in addition to the duty imposed by the text of the warning provisions of FIFRA’s misbranding requirements.”[144] Further, even though Novartis argued a reading of FIFRA where tank mixing[145] instructions were not required, it was not enough to overcome the strong presumption against preemption established by the Court in Bates.[146]

Other courts have broadly defined what is considered “different from” FIFRA requirements. For example, in Carson v. Monsanto Company, the plaintiffs brought a claim against Monsanto, stating that it failed to warn of the risk of cancer from Roundup.[147] Under Georgia law, “‘the duty to warn arises whenever the manufacturer knows or reasonably should know of the danger arising from the use of its product.’”[148] The court held that the state law was preempted.[149] Because the state law requiring a cancer label conflicted with EPA’s approved label, the state law imposed a duty that is different from the requirements of FIFRA.[150] Here, the court implicitly ruled that because the EPA approved the label, the original label complied with FIFRA. However, as discussed later in this Note, initial EPA approval of a label is not a defense for a violation of FIFRA.[151] While the case was ultimately reversed on that basis,[152] the district court case is illustrative of a possible line of reasoning. Critically, FIFRA allows states to impose penalties on manufacturers for violations of FIFRA, but it does not allow the states to impose new requirements. The Bates Court, borrowing from Justice Sandra Day O’Connor’s concurring opinion in a Medical Device Amendments case, explained that:

a state cause of action that seeks to enforce a federal requirement “does not impose a requirement that is ‘different from, or in addition to,’ requirements under federal law. . . . [T]he requirements imposed on [manufacturers] under state and federal law do not differ. [The statute] does not preclude States from imposing different or additional remedies, but only different or additional requirements.”[153]

Thus, states are allowed to impose their own penalties for violations of FIFRA, so long as the requirements under the state law parallel the requirements under FIFRA. Because FIFRA does not contain any victim relief for manufacturer violations, state laws are the only avenues for monetary relief for pesticide-related injuries.

Therefore, courts are generally slow to find that a state law is “in addition to or different from” FIFRA. This is partly due to the broad scope of FIFRA’s misbranding provision—many state laws are similarly broad. However, a court may find preemption if the state law is broader than FIFRA, or if the court broadly interprets what it means to be “different.” Fortunately, for pesticide victims, a state may impose different remedies while avoiding preemption.

4. Takeaways for Express Preemption

In sum, a state law is expressly preempted if it (1) imposes a requirement (2) for labeling or packaging (3) in addition to or different from those required under FIFRA. A requirement can be a common law duty, such as the duty to warn. A state law pertaining to the quality of the product or use of the product is not for labeling or packaging. A state law requirement is not “in addition to or different” from FIFRA if the law contains similar wording, is narrower, or the court narrowly interprets the phrase. However, a state law requirement is “in addition to or different” from FIFRA if the law is broader or the court broadly interprets the phrase.

What emerges is a framework where claims of defective design, defective manufacture, negligent testing, and breach of express warranty are not preempted because they are not “for labeling or packaging.” For laws that satisfy the first two conditions, courts are slow to find preemption. Because FIFRA’s misbranding provision is so broad, courts can find consistency between the state law and FIFRA in most cases. However, state laws are preempted in situations where the law is broader than FIFRA, and where a court adopts a broader interpretation of the phrase “in addition to or different from.” Under this framework, most state laws are not expressly preempted.

B. Implied Preemption

The Court did not address implied preemption in Bates. In fact, in his concurring opinion in Bates, Justice Clarence Thomas noted that the lack of conflict preemption discussion comports with the Court’s reluctance to address implied preemption.[154] While the Supreme Court has not discussed implied preemption in relation to FIFRA, lower courts have ruled on this question.

1. Is Implied Preemption Precluded?

There exists a legal theory that implied preemption is precluded altogether for FIFRA.[155] In Bourbia v. S.C. Johnson & Son, Inc., the Southern District Court of New York stated that implied preemption is “foreclosed” because Congress fully defined the preemptive reach of FIFRA in Section 136v(b).[156] Its reasoning stems from the statutory construction principle of expressio unius est exclusio alterius, where the express mention of one means the exclusion of others of the same class.[157] Under that logic, because Congress limited the preemptive reach to that expressly stated in Section 136v(b), it did not intend any further preemption. The Court also found support in Cipollone v. Liggett Grp., Inc., where the Supreme Court ruled that because the Federal Cigarette Labeling and Advertising Act contained express provisions, “Congress’ enactment of a provision defining the pre-emptive reach of a statute implies that matters beyond that reach are not pre-empted.”[158]

However, in a later case, the Supreme Court stated that the existence of an express preemption clause “does not . . . foreclose[] any possibility of implied pre-emption.”[159] In other words, even if a law contains an express preemption provision, a court can still proceed to the implied preemption analysis. So, for FIFRA, an implied preemption analysis is arguably applicable despite the presence of an express preemption clause.[160] Although seemingly at odds with the holding in Cipollone, the Supreme Court clarified: “At best, Cipollone supports an inference that an express pre-emption clause forecloses implied pre-emption; it does not establish a rule.”[161]

To support an inference that implied preemption is foreclosed, a court must look for the intent of Congress to determine the statute’s preemptive reach.[162] In Cipollone, the Federal Cigarette Labeling and Advertising Act’s express preemption provision prohibited states from imposing any cigarette labeling requirements related to smoking and health.[163] The Act’s statement of purpose expressed an intent to avoid “diverse, nonuniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health.”[164] The Court ruled that the preemptive scope of the Act is “governed entirely” by the express preemption provision because it provided a “reliable indicium of congressional intent with respect to state authority.”[165] Although the Court also found support with statutory construction principles, its main rationale came from Congress’s intent.

It appears that Congress similarly intended to limit the preemptive reach of FIFRA to the express preemption provision. An express preemption provision exists, which at least supports an inference that Congress intended to limit the scope of preemption.[166] Also, the express preemption provision in FIFRA alone sufficiently defines the scope of FIFRA preemption. It provides that states “shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.”[167] As stated by the Court, FIFRA does not preempt a state law that is “equivalent to, and fully consistent with, FIFRA’s misbranding provisions.”[168] There is a clear distinction between state laws preempted and those not preempted.

Looking further, Congress intended for broad state participation in pesticide regulation. In the express preemption provision, Congress sought to save state laws that are consistent with FIFRA, indicating that it desired some state laws. Also, Section 136v(a) gives states the ability to regulate the sale of any federally registered pesticide, as long as it does not permit the sale of a pesticide banned under FIFRA. From these FIFRA provisions, the Court has interpreted Congress’s intent for the state remedies to “serve as a catalyst” in the development of pesticide labels.[169] Because state laws promote disclosure of adverse effects from manufacturers, state laws “aid, rather than hinder” the evolution of pesticide labels into more accurate representations of the products.[170] The Court itself contrasted the benefits of state participation in FIFRA with the desire for a uniform cigarette warning in Cipollone.[171] Because Congress intended broad state participation, it limited preemption of the state laws to the express preemption provision.

Similarly, although perhaps least persuasive,[172] “[t]he long history of tort litigation against manufacturers of poisonous substances adds force to the basic presumption against pre-emption. If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly.”[173] The Bates Court found it unlikely that Congress would use “a relatively obscure provision” like Section 136v(b) to preempt state laws without giving its “clear and manifest” intention to do so.[174]

Taken together, implied preemption analysis is likely foreclosed under FIFRA. Like the express preemption provision in Cipollone, FIFRA’s provides a “reliable indicium of congressional intent with respect to state authority.”[175] The text of the provision is clear about what is and is not preempted. Also, FIFRA provisions support the inference that Congress intended for the type of broad state participation allowed by the express preemption provision. Finally, Congress would have expressly indicated if it wanted to disrupt the long history of pesticide litigation. Although the Court in Bates did not go as far as saying FIFRA preemption is limited to the express preemption provision, its reasoning dictates no other finding.[176]

2. Impossibility Preemption

Even when courts reason that implied preemption is precluded, many will engage in the implied preemption analysis anyway. The leading theory of implied preemption in FIFRA cases is impossibility preemption. Impossibility preemption occurs when it is impossible to comply with both state and federal requirements. The argument is that it is impossible to comply with both FIFRA, which requires EPA approval before changing a label, and state law, which requires immediate altering of the label.[177]

In practice, once state law requires a manufacturer to change its label, the manufacturer should submit a petition to the EPA to change its label.[178] Critically, the application for label change must be approved before a manufacturer can sell the product with the modified label.[179] Assuming that the change was required under FIFRA, the EPA would approve the change and the amended label would be the national label requirement for that pesticide product.

The main contention is that because the manufacturers must petition the EPA, they cannot simultaneously comply with federal and state requirements.[180] A state law that requires a label change in effect bans the pesticide from sale until the label is changed. FIFRA does not require that a registered pesticide be made available for sale. In fact, a state is allowed to ban pesticide sales under FIFRA: “[a] State may regulate the sale or use of any federally registered pesticide or device in the state.”[181] Because a state can ban a pesticide entirely, it can temporarily ban a pesticide pending a label change.[182] Thus, although inconvenient, it is not impossible for a manufacturer to change its label in compliance with both state law and FIFRA.

3. Registration as a Defense

In addition to impossibility preemption, manufacturers also argue that because the pesticide has been approved by the EPA, it is compliant with FIFRA, and any state law requiring a labeling change conflicts with FIFRA.[183] This argument fails based on the wording of FIFRA.

Under Section 136a(f)(2), “[i]n no event shall registration of an article be construed as a defense for the commission of any offense under [FIFRA].” Put differently, approval by the EPA is not a defense against violations of FIFRA. Assuming a manufacturer violated a state law that is fully consistent with FIFRA, the manufacturer in fact violated FIFRA and thus cannot use registration of the pesticide as a defense against that violation.[184]

Therefore, the argument that registration is a defense against state law violations is easily overcome by FIFRA itself. As stated by the Third Circuit, “mere inconsistency between the duty imposed by state law and the content of a manufacturer’s labeling approved by the EPA at registration [does] not necessarily mean that the state law duty was preempted.”[185]

4. Takeaways from Implied Preemption

In sum, implied preemption analysis is precluded under FIFRA because Congress intended for the express preemption clause to fully address preemption under FIFRA. Some argue that the Supreme Court implicitly ruled so in Bates.[186] Even if it did not, the Court’s reasoning in Bates leads to no other outcome. Also, when a court engages in implied preemption analysis, the impossibility theory and registration defense are easily overcome by FIFRA.

Some courts will preclude implied preemption analysis entirely, while others will claim it does not apply but will proceed with the analysis anyway. Even when a court undertakes a preemption analysis, the argument almost always fails.

IV. The Future of FIFRA Preemption

A. Hardeman v. Monsanto Analysis

Although the Supreme Court denied review of Hardeman v. Monsanto, it is not unrealistic to expect that a similar case will surface in the future.[187] Although the facts of Hardeman might not exactly repeat, an analysis of those facts is warranted to illustrate the strength of FIFRA. In Hardeman, Monsanto unsuccessfully claimed that FIFRA both expressly and impliedly preempts the California failure-to-warn law.

Monsanto argued that the California law was expressly preempted because it imposed requirements “in addition to or different from” what the EPA requires.[188] On the one hand, the California law required a cancer warning for glyphosate-based pesticides.[189] On the other hand, the EPA communicated, via a 2019 letter, that a manufacturer violated FIFRA if it placed a cancer warning on a glyphosate-based pesticide.[190] Monsanto claimed it could not add the cancer warning to the label, as required by state law, because it imposed a requirement “different” from what FIFRA required (as interpreted by the EPA[191]).

Monsanto also argued that it was impossible to comply with California state law and FIFRA. Based on the EPA’s 2019 letter, Monsanto claimed that the EPA would reject a petition to add a cancer warning to the label.[192] Thus, it would be impossible to comply with the state law, which requires a cancer warning, because the EPA would inevitably reject such a proposal.

These arguments were destined to fail because they assumed too little of FIFRA. The crux of Monsanto’s argument was that the EPA’s letter interpreting FIFRA prevented Monsanto from making any label changes. First, the California cancer warning requirement was not expressly preempted because it was “fully consistent” with FIFRA. FIFRA requires that a pesticide label “contain a warning or caution statement which may be necessary and if complied with . . . is adequate to protect the health and the environment.”[193] California common law requires a manufacturer to warn of a health risk that is “known or knowable” or of risks “a reasonably prudent manufacturer would have known and warned about.”[194] The Ninth Circuit correctly ruled that FIFRA is, “at minimum, consistent with California’s requirement[s].”[195] Monsanto simply made a guised registration-as-a-defense argument which failed for the reasons discussed earlier. Just because the EPA has decided that a cancer warning was not needed does not mean that adding one would violate FIFRA.

Second, implied preemption considerations are precluded under FIFRA. Even considering implied preemption, Monsanto could have added, or at least petitioned to add, a cancer warning. Although the interim California sales bans were inconvenient, they were lawful.

Assuming Monsanto had petitioned to the EPA to add a cancer warning, the EPA’s decision to approve or disapprove a proposed label change was largely dictated by FIFRA. Under Section 136a(f)(1), “[i]f the labeling or formulation for a pesticide is changed, the registration shall be amended to reflect such change if the Administrator determines that the change will not violate any provision of this subchapter.” (emphasis added). Put differently, the EPA must integrate the requested label change into the registration as long as it determines that such a change will not violate FIFRA.[196] The EPA might have argued that a cancer warning for glyphosate products would constitute a “false or misleading statement,” and the EPA likely had discretion to so decide.[197] However, it runs afoul of Section 136(q)(1)(G), which states that a pesticide is mislabeled if the label does not contain a warning or caution statement that is necessary to protect health and the environment.[198] So, even if the Court were to follow a similar presumed progression, FIFRA validates the state law requirement.

Thus, the express and implied preemption arguments are easily defeated in Hardeman. A similar case in the future would likely reach the same outcome. The clear requirements under FIFRA, as defined by Bates, are not easily circumvented.

B. The Role of the EPA

When the EPA issued the letter stating that placing a cancer warning on a glyphosate product was a violation of FIFRA, it was essentially warranting that glyphosate does not and cannot cause cancer. By doing so, the EPA assumed a high level of authority that it may not have. It must be determined if that much power is desirable.

As an initial matter, the EPA likely does not have the statutory authority to unilaterally rule a pesticide safe. Such an action cuts against Congress’s intent in writing FIFRA in the first place. FIFRA is designed to foster state participation in pesticide regulation.[199] Congress did not intend to give the EPA unilateral authority to determine whether a chemical is safe; otherwise, Section 136v(a) would have no meaning.[200] And, if it did intend to give the EPA those powers to abdicate state requirements, it would have indicated that.[201]

Also, giving the EPA unilateral authority would reduce the type of information available on the pesticide. In the Hardeman example, the EPA stating that a cancer warning is false and misleading is equivalent to it stating that a warning is not necessary to protect health and the environment. That would cut directly against California’s determination that the cancer warning is needed. The state findings have the value of being based on real world cases from tort law, and the EPA merely reviews studies. The variation in sources of information is exactly what Congress intended in writing FIFRA.

Finally, there exists the possibility that the EPA is subject to the influence of the pesticide industry. Although the EPA would never make a statement admitting it, the whistleblower accounts suggest that pesticide manufacturers have at least some impact on the pesticide review process.[202] Even if the accounts represent a minority of EPA actions, it would be wise to continue to allow state law tort claims to influence pesticide labeling. The state law acts as a second set of eyes on the harmful effects of pesticides, outside the reach of the pesticide industry. State law claims also help fill in any gaps left from the conditional registration loophole.

Thus, there are compelling reasons to deny the EPA unilateral authority to deem a pesticide safe. It does not have the statutory basis to do so, and state law claims act as real-world cases of pesticide harm, outside the reach of extraneous influences.

C. Future Litigation

The Court should affirm Bates in future FIFRA preemption cases. FIFRA and Bates control the outcome in most fact patterns, and there is no compelling reason to depart from either. As it stands, the analysis for any FIFRA preemption case begins and ends with deciding whether the state labeling law is consistent with FIFRA; if it is, then the FIFRA and state law provisions dictate whether there is a violation and the state law provides the remedy.

The Bates framework allows for an important form of relief to victims like Edwin Hardeman. It also allows for a more frequent review of pesticide safety, beyond the fifteen-year cycle currently required by FIFRA. Further, under this framework, the decision-making process is outside the EPA’s sole discretion, which is what Congress intended. If the Court takes a future case and overturns Bates, it would close off an important avenue of relief for victims of pesticide exposure.

Conclusion

State laws play an important role for victims of pesticide injury. Because FIFRA does not provide any relief, a victim’s only source of compensation comes from state law. Also, state laws bring meaningful developments to the industry. For example, although adding a cancer warning may seem trivial, the presence of a cancer warning could persuade a consumer to forgo using the pesticide, or at least be more careful with the application method. Such changes can ferret out dangerous products and can motivate manufacturers to discontinue sales.

Fortunately, courts are slow to find FIFRA preemption of state laws. To be sure, some state law claims are categorically not preempted because they do not impose requirements “in addition to or different from” FIFRA’s. However, the label-related state laws that do undergo preemption analysis are on strong footing under the current Bates framework. Only labeling laws that provide additional or different requirements are expressly preempted. Also, there is good reason to believe that implied preemption is entirely precluded from FIFRA preemption analysis. Even if a court engages with the implied preemption analysis, it is almost never impossible to comply with the state law and FIFRA.

The Hardeman case provided an interesting situation where the EPA stated that a cancer warning for glyphosate constitutes a violation of FIFRA. As decided by the Ninth Circuit, the California law is not expressly preempted nor impliedly preempted. Monsanto needs to go through the proper channels to seek approval for the cancer warning, although this would mean conceding that the California law is not expressly preempted. Fortunately for Edwin Hardeman, the judgment is secure.

The Supreme Court should uphold the current Bates framework in the future. Courts are slow to find preemption under Bates, which bodes well for current victims and future pesticide consumers. Bates has stood the test of time over nearly two decades, and it should continue to govern FIFRA preemption because it accurately reflects the essence of the statute and the intent of Congress.

  1. *J.D. Candidate, 2023, University of Colorado Law School; I would like to thank my fellow Colorado Environmental Law Journal members for all their hard work in making this publication possible. I would also like to thank my family for supporting me during law school.
  2. State failure-to-warn laws are not the only state tort laws available, but failure-to-warn laws are the subject of this Note because the preemption issue discussed here only applies to laws that impact labeling, and many other state tort laws do not address labeling.
  3. 7 U.S.C. § 136v(b) (2018).
  4. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 444 (2005).
  5. Hardeman v. Monsanto Co., 997 F.3d 941, 950 (9th Cir. 2021), cert. denied, 142 S. Ct. 2834 (2022).
  6. Id. at 954. See also Monsanto Co. v. Hardeman, 142 S.Ct 2934 (2022) denying cert to 997 F.3d 941 (9th Cir. 2021); see also Brief for the United States as Amicus Curiae at 6, Hardeman v. Monsanto Co., 997 F.3d 941 (9th Cir. 2021) (No. 21-241).
  7. Hardeman, 997 F.3d at 976.
  8. Pesticides, Nat’l Inst. of Env’t Health Scis., https://www.niehs.nih.gov/health/ topics/agents/pesticides/index.cfm (last visited Apr. 3, 2022). A pest is an organism living and growing where they are not wanted and can cause damage to plants, humans, structures, and other creatures, including crops that are grown for food. Pests and Pesticides in Agriculture, Penn State Extension, https://extension.psu.edu/pests-and-pesticides-in-agriculture (last updated June 30, 2022).
  9. Types of Pesticide Ingredients, EPA, www.epa.gov/ingredients-used-pesticide-products/types-pesticide-ingredients (last updated June 7, 2022).
  10. Pesticide Industry Sales and Usage, 2008–2012 Market Estimates, EPA 11 (2017), https://www.epa.gov/sites/default/files/2017-01/documents/pesticides-industry-sales-usage-2016_0.pdf.
  11. New standards to curb the global spread of plant pests and diseases, Food & Agric. Org. of the U.N. (Apr. 3, 2019), https://www.fao.org/news/story/en/item/11877 38/icode/.
  12. Jessica Eise, World hunger surged in 2020, with 1 in 10 people on Earth undernourished, The Conversation (July 14, 2021), https://theconversation.com/world-hunger-surged-in-2020-with-1-in-10-people-on-earth-undernourished-164379.
  13. Jorge Fernandez-Cornejo et al., Pesticide Use in U.S. Agriculture: 21 Selected Crops, 1960-2008 1 (2014), https://www.ers.usda.gov/webdocs/publications/ 43854/46734_eib124.pdf?v=6601.4. “During the same period, cotton yields rose nearly fourfold, and soybean yields increased more than threefold.” Id.
  14. Id.
  15. Potential Health Effects of Pesticides, PennState Extension, https://extension. psu.edu/potential-health-effects-of-pesticides (last updated June 30, 2022).
  16. Id.
  17. Id.
  18. Id.; Reini Bretveld et al., Pesticide Exposure: The Hormonal Function of the Female Reproductive System Disrupted?, 4 Reprod. Biology & Endocrinology 33 (2006) (“Reproductive effects that have been associated with pesticide exposure in women are decreased fertility, spontaneous abortions, stillbirth, premature birth, low birth weight, developmental abnormalities, ovarian disorders, and disruption of the hormonal function.”).
  19. Agency for Toxic Substances and Disease Registry, Sensitive Populations and Chemical Exposure 1,

    https://www.atsdr.cdc.gov/emes/public/docs/Sensitive%20Populations%20FS.pdf (last visited Apr. 3, 2022). Farm workers can be exposed to pesticide levels hundreds of times greater than consumers’ exposure. Farmworker Justice, Exposed and Ignored: How Pesticides are Endangering our Nation’s Farmworkers 3 (2013).

  20. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Facilities, EPA, https://www.epa.gov/enforcement/federal-insecticide-fungicide-and-rod enticide-act-fifra-and-federal-facilities (last visited Aug. 8, 2022). It has been continuously amended since then. Id.
  21. Summary of the Federal Insecticide, Fungicide, and Rodenticide Act, EPA, https:// www.epa.gov/laws-regulations/summary-federal-insecticide-fungicide-and-rodenticide-act (last visited Apr. 3, 2022).
  22. Id.; 7 U.S.C. § 136a(c)(5)(C) (2018). As defined in 7 U.S.C. § 136(bb) (2018), “[t]he term ‘unreasonable adverse effects on the environment’ means (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of title 21.” § 136(bb).
  23. About Pesticide Registration, EPA, https://www.epa.gov/pesticide-registration/ab out-pesticide-registration (last visited Apr. 3, 2022).
  24. Id.
  25. Id.
  26. Jennifer Sass & Mae Wu, Superficial Safeguards: Most Pesticides Are Approved by Flawed EPA Process, NRDC 1 (2013), https://www.nrdc.org/sites/default/ files/flawed-epa-approval-process-IB.pdf.
  27. Id. at 2.
  28. Id. at 1.
  29. Id. at 2.
  30. As of 2010, there were over 16,000 approved pesticides. Id. at 1.
  31. Sharon Lerner, The Department of Yes: How Pesticide Companies Corrupted the EPA and Poisoned America, The Intercept (June 30, 2021), https://theintercept.com /2021/06/30/epa-pesticides-exposure-opp/. This article provides an accounting of multiple whistleblower complaints against the EPA. Id. When asked to comment on the article, Senator Richard Blumenthal described the findings as “profoundly alarming,” and he indicated that he will push for stronger safeguards in the pesticide registration process. Id.
  32. Id.
  33. Id.
  34. Id.
  35. Id. The toxicologist was repeatedly threatened with disciplinary action and was eventually written up for failing to meet a deadline that was changed without the toxicologist’s knowledge. Id.
  36. See Angus Liu, Worst deal ever? Bayer’s market cap now close to the total cost it paid for Monsanto, Fierce Pharma (Aug. 29, 2019), https://www.fiercepharma.com/ pharma/worst-deal-ever-bayer-s-market-cap-now-close-to-total-cost-it-paid-for-monsanto. Bayer AG acquired the Monsanto company in 2018. Id.
  37. Monsanto, Roundup Powermax Herbicide Complete Directions for Use 1, https://s3-us-west-1.amazonaws.com/agrian-cg-fs1-production/pdfs/Roundup_PowerMA X1e_Herbicide_Label.pdf (last visited Apr. 4, 2022).
  38. Research and Markets: Global Glyphosate Market for Genetically Modified and Conventional Crops 2013 – 2019, Reuters (Apr. 30, 2014), https://web.archive.org/web/ 20150924200327/https://www.reuters.com/article/2014/04/30/research-and-markets-idUSnBw306202a+100+BSW20140430.
  39. See Global Industry Analysts, Inc., Glyphosate – Global Market Trajectory & Analytics, Rsch. and Mkts. (Oct. 2022), https://www.researchandmarkets.com/reports /1946781/glyphosate_global_market_trajectory_and?utm_source=GNOM&utm_medium=PressRelease&utm_code=ncx6z2&utm_campaign=1692838+-+Global+Glyphosate+M arket+Report+2022-2026%3a+Growing+Adoption+of+GM+Crops+Underpins+Volume +Sales&utm_exec=chdo54prd (last visited Oct. 26, 2022). The Freedonia Group, Global Pesticides Market 2021-2030, Rsch. and Mkts. (Aug. 2021), https://www.researchandm arkets.com/reports/5562814/global-pesticides-market-2021-2030 (last visited Oct. 26, 2022).
  40. Glyphosate, EPA, https://www.epa.gov/ingredients-used-pesticide-products/glyp hosate (last visited Apr. 4, 2022). FIFRA dictates that each pesticide must be reviewed for compliance with FIFRA at least once every 15 years. 7 U.S.C. § 136a(g)(1)(A)(iv) (2018).
  41. Glyphosate, EPA, https://www.epa.gov/ingredients-used-pesticide-products/glyph osate (last visited Apr. 4, 2022).
  42. Christopher J. Portier, A Comprehensive Analysis of the Animal Carcinogenicity Data for Glyphosate from Chronic Exposure Rodent Carcinogenicity Studies, 19 Env’t Health 1 (2020). This study reviewed 13 glyphosate studies that found the chemical to be carcinogenic. Id. at 2.
  43. IARC Monograph on Glyphosate, World Health Org. Int’l Agency for Rsch. on Cancer, https://www.iarc.who.int/featured-news/media-centre-iarc-news-glyphosate/ (last visited on Apr. 4, 2022).
  44. Patricia Cohen, Roundup Maker to Pay $10 Billion to Settle Cancer Suits, N.Y. Times (June 24, 2020), https://www.nytimes.com/2020/06/24/business/roundup-settlemen t-lawsuits.html.
  45. Hardeman v. Monsanto Co., 997 F.3d 941 (9th Cir. 2021), cert. denied, 142 S. Ct. 2834 (2022).
  46. Sam Levin, The family that took on Monsanto: ‘They should’ve been with us in the chemo ward’, The Guardian (Apr. 10, 2019), https://www.theguardian.com/business/ 2019/apr/10/edwin-hardeman-monsanto-trial-interview.
  47. Id.
  48. ​​Id.; Non-Hodgkin’s lymphoma is a type of cancer where white blood cells grow abnormally, which can lead to tumor growth throughout the body. Non-Hodgkin’s lymphoma, Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/non-hodgkins-lymphoma/symptoms-causes/syc-20375680 (last visited Apr. 4, 2022).
  49. Complaint at 24, In re Roundup Prod. Liab. Litig., 385 F. Supp. 3d 1042 (N.D. Cal. 2019), aff’d sub nom. Hardeman, 997 F.3d at 941 (No. 4:16-cv-00525-DMR), https:// usrtk.org/wp-content/uploads/2018/12/Edward-Hardeman-1st-amended-complaint-Feb.-2016.pdf.
  50. See 16-2741 – In re Roundup Products Liability Litigation, GovInfo, https://www. govinfo.gov/app/details/USCOURTS-cand-3_16-md-02741/USCOURTS-cand-3_16-md-02741-16/summary (last visited Apr. 4, 2022).
  51. In re Roundup Prod. Liab. Litig., 385 F. Supp. 3d at 1044. The court ultimately reduced the punitive damages award to $20 million.
  52. Hardeman v. Monsanto Co., 997 F.3d 941, 950 (9th Cir. 2021), cert. denied, 142 S. Ct. 2834 (2022).
  53. Petition for Writ of Certiorari, Hardeman, 997 F.3d 941, cert. denied, 142 S. Ct. 2834 (2022) (No. 21-241).
  54. See id. This brief indicated that circuit split would weigh in favor of Supreme Court review. Brief for the United States as Amicus Curiae at 19, Hardeman, 997 F.3d 941 (9th Cir. 2021) (No. 21-241).
  55. E.g., Nat’l Fam. Farm Coal. v. U.S. Env’t Prot. Agency, 960 F.3d 1120, 1145 (9th Cir. 2020) (challenge to registration of pesticide resulted in remand to EPA for further review).
  56. Mary Cabrera, Legal Remedies for Victims of Pesticide Exposure, 1 Kan. J. L. & Pub. Pol’y 113, 116 (1991).
  57. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 448 (2005). (“Accordingly, although FIFRA does not provide a federal remedy to farmers and others who are injured as a result of a manufacturer’s violation of FIFRA’s labeling requirements, nothing in [7 U.S.C.] § 136v(b) precludes States from providing such a remedy.”).
  58. Johnson v. Monsanto Co., No. CGC16550128, 2018 WL 4261442, at *2 (Cal. Super. Ct., 2018), modified in part, rev’d in part 266 Cal. Rptr. 3d 111 (Cal. Ct. App. 2020). Johnson is distinguishable from Hardeman because Johnson was tried in state court.
  59. See Bayer AG ADR, Barron’s, https://www.barrons.com/market-data/stocks /bayry/interactive-chart#subnav (last visited Oct. 31, 2022). The stock fell from around $23.38 per share on 08/01/2018 to around $14.57 per share on 08/01/2022. See id.
  60. Purbita Saha, Roundup is finally going to be made without glyphosate in the US, Popular Sci. (Aug. 6, 2021), https://www.popsci.com/health/bayer-lawsuit-phase-out-roundup/.
  61. Hardeman v. Monsanto Co., 997 F.3d 941, 976 (9th Cir. 2021), cert. denied, 142 S. Ct. 2834 (2022).
  62. Appeals Court Affirms Historic Roundup Cancer Plaintiff Victory Against Monsanto, Ctr. for Food Safety (May 14, 2021), https://www.centerforfoodsafety.org/ press-releases/6366/appeals-court-affirms-historic-roundup-cancer-plaintiff-victory-again st-monsanto. It is also a bellwether because the court affirmed the decision to admit evidence that the International Agency for Research on Cancer concluded that glyphosate is “probably carcinogenic” to humans. Hardeman, 997 F.3d at 950; IARC Monograph on Glyphosate, World Health Org. Int’l Agency for Rsch. on Cancer, https://www.iarc. who.int/featured-news/media-centre-iarc-news-glyphosate/ (last visited on Apr. 4, 2022). The Agency’s conclusion did not factor into the EPA’s approval of glyphosate because the “EPA does not agree with [the International Agency for Research on Cancer’s] conclusion….” Glyphosate, EPA, https://www.epa.gov/ingredients-used-pesticide-produc ts/glyphosate (last visited Apr. 4, 2022).
  63. Five-Point Plan to Close the Roundup™ Litigation, Bayer, https://www.bayer .com/en/roundup-litigation-five-point-plan#:~:text=Our%20five%2Dpoint%20plan%2C %20announced,innovations%2C%20and%20contributions%20to%20society (last visited Apr. 4, 2022).
  64. Petition for Writ of Certiorari at 2, Hardeman, 997 F.3d 941, cert. denied, 142 S. Ct. 2834 (2022) (No. 21-241). The other argument, not discussed in this Note, is that the expert testimony used in the trial is inadmissible. See id. at 26.
  65. See U.S. Const. art. VI; Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000).
  66. E.g., Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).
  67. Retail Clerks International Association, Local 1625 v. Schermerhorn, 375 U.S. 96, 103 (1963).
  68. Crosby, 530 U.S. at 372.
  69. Id.
  70. Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
  71. Rice, 331 U.S. at 230.
  72. 7 U.S.C. § 136v(b).
  73. Hardeman v. Monsanto Co., 997 F.3d 941, 958 (9th Cir. 2021), cert. denied, 142 S. Ct. 2834 (2022).
  74. § 136v(a).
  75. State Pesticide Regulation, Nat’l Pesticide Info. Ctr., http://npic.orst.edu/reg/ regstate.html (last updated Sept. 22, 2020).
  76. § 136(p)(1).
  77. § 136(p)(2).
  78. Labeling Requirements, EPA, https://www.epa.gov/pesticide-registration/label ing-requirements#:~:text=The%20label%20on%20a%20pesticide,human%20health% 20and%20the%20environment (last updated June 1, 2022).
  79. § 136j(a)(1)(E).
  80. § 136(q).
  81. § 136(q)(1)(A).
  82. § 136(q)(1)(G). Section 136a(d) provides classifications of pesticides for general use, restricted use, or both. A pesticide is approved for general use if the pesticide “will not generally cause unreasonable adverse effects on the environment.” § 136a(d)(1)(B).
  83. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 438 (2005) (“Because it is unlawful under [FIFRA] to sell a pesticide that is registered but nevertheless misbranded, manufacturers have a continuing obligation to adhere to FIFRA’s labeling requirements.”).
  84. § 136d(a)(2); 40 C.F.R. § 159.152 (2021).
  85. 40 C.F.R. § 156.62; § 156.64.
  86. § 156.62.
  87. Id.
  88. § 156.64.
  89. Cal. Env’t Prot. Agency Off. of Env’t Health Hazard Assessment, Initial Statement of Reasons Title 27, California Code of Regulations Proposed Amendments to Article 6 Clear and Reasonable Warnings Amendment to Section 25603 Consumer Product Exposure Warnings – Content: Signal Words for FIFRA-Regulated Pesticide Exposure Warning Labels 3 (2018), https://oehha.ca.gov/ media/downloads/crnr/pesticidewarningsisor042318_0.pdf.
  90. Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005).
  91. Dow Agrosciences LLC v. Bates, 332 F.3d 323, 325 (5th Cir. 2003), vacated, 544 U.S. 431 (2005).
  92. Bates, 544 U.S. at 435.
  93. Dow Agrosciences LLC, 332 F.3d at 325.
  94. Bates, 544 U.S. at 435–36. The other counterclaims were for negligence, breach of implied and express warranties, fraud, fraud in the inducement, estoppel, and waiver. Dow Agrosciences LLC, 332 F.3d at 326. The original defective design claim is really a “disguised claim for failure to warn.” Id. at 332.
  95. Dow Agrosciences LLC, 332 F.3d at 332–33. Cited the “inducement test” is its reason, which the Supreme Court rejected on remand. Infra at note 109.
  96. Bates, 544 U.S. at 434.
  97. Id. at 454.
  98. Id. at 444 (quoting 7 U.S.C. § 136v(b)).
  99. Id. at 443.
  100. Id. at 447 (referred to as the “parallel requirements” reading of § 136v(b)).
  101. Id. at 451.
  102. Id.
  103. Id. (quoting Ferebee v. Chevron Chem. Co., 736 F.2d 1529, 1541–1542 (1984)).
  104. Id. at 453.
  105. Id. at 449.
  106. 7 U.S.C. § 136v(b).
  107. Bates, 544 U.S. at 444.
  108. Requirement, Black’s Law Dictionary (11th ed. 2019).
  109. Bates, 544 U.S. at 443.
  110. Id. The Court rejects what it calls the “inducement test” or “effects-based test.” Id. at 445. It ruled that the requirement analysis does not call for speculation into how a jury verdict will influence the decision-making of the manufacturer. Id. Also, based on a state’s power to ban pesticides under § 136v(a), even though a state banning a pesticide may induce a manufacturer to change its label, Congress likely did not consider the act of banning a requirement on manufacturers. Id. at 446. See 7 U.S.C. § 136v(a).
  111. Bates, 544 U.S. at 444.
  112. Id. at 444.
  113. Indian Brand Farms, Inc. v. Novartis Crop Prot. Inc., 617 F.3d 207, 218 (3d Cir. 2010). While FIFRA defines labeling as graphic matter accompanying the pesticide, and a marketing brochure arguably accompanies a label, the court in Indian Brand Farms reasoned that Congress did not intend to regulate sales literature—it intended label uniformity throughout the country. Id. at 218–19.
  114. DJ Coleman, Inc. v. Nufarm Ams., Inc., 693 F. Supp. 2d 1055, 1081 n.9 (D.N.D. 2010).
  115. S. Agric. Insecticides, Inc. v. Taylor, 563 F.Supp.3d 1127, 1140 (D. Or. 2021) (the law did not require the manufacturers to manage their labels in any certain way–instead, it required that the product comply with what is written on the label).
  116. Schoenhofer v. McClaskey, 861 F.3d 1170, 1174 (10th Cir. 2017) (because the law does not say anything about the “written, printed, or graphic matter” associated with the pesticide, it does not govern labeling).
  117. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 444 (2005).
  118. Wuebker v. Wilbur-Ellis Co., 418 F.3d 883, 887 (8th Cir. 2005).
  119. Bates, 544 U.S. at 446 (quoting 7 U.S.C. § 136v(b)).
  120. Id. at 447.
  121. Hardeman v. Monsanto Co., 997 F.3d 941, 955 (9th Cir. 2021).
  122. Bates, 544 U.S. at 447.
  123. Id. at 454 (“indeed, it would be surprising if a common-law requirement used the same phraseology as FIFRA”).
  124. Id. at 453.
  125. Id. (“For example, a failure-to-warn claim alleging that a given pesticide’s label should have stated ‘DANGER’ instead of the more subdued ‘CAUTION’ would be pre-empted because it is inconsistent with 40 CFR § 156.64 (2004), which specifically assigns these warnings to particular classes of pesticides based on their toxicity.”).
  126. S. Agric. Insecticides, Inc. v. Taylor, 563 F. Supp. 3d 1127, 1135 (D. Or. 2021).
  127. Id.
  128. Blitz v. Monsanto Co., 317 F. Supp. 3d 1042, 1049 (W.D. Wis. 2018) (quoting Wis. Stat. § 100.18).
  129. Id.
  130. Beyond Pesticides v. Monsanto Co., 311 F. Supp. 3d 82, 86 (D.D.C. 2018).
  131. Id. at 92 (quoting D.C. Code § 28-3904).
  132. 7 U.S.C. § 136(q)(1)(A).
  133. Beyond Pesticides, 311 F. Supp. 3d at 92.
  134. DJ Coleman, Inc. v. Nufarm Ams., Inc., 693 F. Supp. 2d 1055, 1080–81 (D.N.D. 2010).
  135. Id. at 1058–59.
  136. Id. at 1081.
  137. Id.
  138. Id. (quoting N.D.C.C. § 51-15-02).
  139. Id.
  140. Indian Brand Farms, Inc. v. Novartis Crop Prot. Inc., 617 F.3d 207, 221–22 (3d Cir. 2010).
  141. Id. at 221.
  142. Id. at 222 (quoting N.J. Stat. Ann. § 2A:58C-2).
  143. 7 U.S.C. § 136(q)(1)(G).
  144. Indian Brand Farms, 617 F.3d at 222-23.
  145. Tank mixing is the combination of one or more agri-chemical products in a tank for application on crops. Valdemar Luiz Tornisielo et al., Pesticide Tank Mixes: An Environmental Point of View, IntechOpen (June 13, 2013), https://www.intechopen.com/ chapters/44957.
  146. Indian Brand Farms, 617 F.3d at 224 (citing Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005)).
  147. Carson v. Monsanto Co., 508 F. Supp. 3d 1369, 1373 (S.D. Ga. 2020), rev’d, 39 F.4th 1334 (11th Cir. 2022).
  148. Id. at 1376 (quoting Chrysler Corp. v. Batten, 450 S.E.2d 208, 211 (1994)).
  149. Id.
  150. Id. “EPA classifies glyphosate as ‘not likely to be carcinogenic to humans.’” Id. at 1373.
  151. 7 U.S.C. § 136a(f)(2).
  152. Carson v. Monsanto Co., 39 F.4th 1334, 1338 (11th Cir. 2022) (“[A] pesticide manufacturer can’t point to EPA registration as a defense to a misbranding violation under FIFRA.”).
  153. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 448 (2005) (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 513 (1996) (O’Connor, J., concurring)).
  154. Bates, 544 U.S. at 459 (Thomas, J., concurring in part and dissenting in part).
  155. An alternate theory not discussed in this Note is one where the Supreme Court’s silence on implied preemption is interpreted as a rejection of implied preemption. Ansagay v. Dow Agrosciences LLC, 153 F. Supp. 3d 1270, 1281 (D. Haw. 2015) (citing Dennis v. Higgins, 498 U.S. 439, 449 (1991)); In re Roundup Prod. Liab. Litig., 364 F. Supp. 3d 1085, 1088. This question remains unresolved.
  156. Bourbia v. S.C. Johnson & Son, Inc., 375 F. Supp. 3d 454, 464 n.3 (S.D.N.Y. 2019) (citing Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 517 (1992)). Section 136v(b) reads: “Such State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.” 7 U.S.C. § 136v(b).
  157. Cipollone, 505 U.S. at 517. expressio unius est exclusio alterius, Merriam-Webster, https://www.merriam-webster.com/legal/expressio%20unius%20est%20exclu sio%20alterius (last visited Apr. 4, 2022).
  158. Cipollone, 505 U.S. at 517.
  159. Freightliner Corp. v. Myrick, 514 U.S. 280, 288 (1995).
  160. Crespo v. S.C. Johnson & Son, Inc., 394 F. Supp. 3d 260, 268 (E.D.N.Y. 2019).
  161. Freightliner, 514 U.S. at 289.
  162. Retail Clerks International Association, Local 1625 v. Schermerhorn, 375 U.S. 96, 103 (1963) (explaining the “purpose of Congress is the ultimate touchstone” of preemption analysis).
  163. Cipollone, 505 U.S. at 515.
  164. Id. at 519.
  165. Id. at 517 (quoting Malone v. White Motor Corp., 435 U.S. 497, 505 (1978)).
  166. See 7 U.S.C. § 136v(b).
  167. Id.
  168. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 447 (2005).
  169. Id. at 451.
  170. Id.
  171. Id.
  172. Id. at 457 (Thomas, J., concurring in part and dissenting in part) (“The history of tort litigation against manufacturers is . . . irrelevant. We cannot know, without looking to the text of § 136v(b), whether FIFRA preserved that tradition or displaced it.”)
  173. Id. at 449.
  174. Id.; Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).
  175. Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 517 (1992) (quoting Malone v. White Motor Corp., 435 U.S. 497, 505 (1978)).
  176. See Bates, 544 U.S. In fact, Justice Thomas stated that the decision “comports with this Court’s increasing reluctance to expand federal statutes beyond their terms through doctrines of implied pre-emption,” hinting that implied preemption analysis is not appropriate because the express preemption provision defines FIFRA’s preemption. Id. at 459 (Thomas, J., concurring in part and dissenting in part).
  177. In re RoundUp Prods. Liab. Litig., 364 F. Supp. 3d 1085, 1088 (N.D. Cal. 2019).
  178. Pesticide Registration Manual: Chapter 6 – Amending a Registered Pesticide Product, EPA, https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-6-amending-registered-pesticide (last updated July 13, 2022). The EPA allows for minor label changes, also called “notifications,” that manufacturers can make without applying to amend registration. Pesticide Registration Manual: Chapter 7 – Notifications and Minor Formulation Amendments, EPA, https://www.epa.gov/pesticide-registration/ pesticide-registration-manual-chapter-7-notifications-and-minor-formulation (last updated July 13, 2022). These include changes such as the brand name of the pesticide, addition or deletion of pests, symbols and graphics, etc. Id. It is still an open question whether a manufacturer can add a cancer warning through this process. Hardeman v. Monsanto Co., 997 F.3d 941, 959–60 (9th Cir. 2021).
  179. Pesticide Registration Manual: Chapter 6 – Amending a Registered Pesticide Product, EPA, https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-6-amending-registered-pesticide (last updated July 13, 2022).
  180. Crespo v. S.C. Johnson & Son, Inc., 394 F. Supp. 3d 260, 272 (E.D.N.Y. 2019).
  181. 7 U.S.C. § 136v(a).
  182. Also, the ban would apply only to the state imposing the requirement, so the manufacturer would still be free to sell in other states under the existing label, unless and until the EPA approves a modified label.
  183. Crespo, 394 F. Supp. 3d at 270.
  184. “‘Initial approval of a label amounts to a finding by the [applicable federal agency] that the label is safe for purposes of gaining federal approval to market the [product]. It does not represent a finding that the [product], as labeled, can never be deemed unsafe by later federal action, or as in this case, the application of state law.’” Ansagay v. Dow Agrosciences LLC., 153 F. Supp. 3d. 1270, 1282–83 (D. Haw. 2015) (quoting Wyeth v. Levine, 555 U.S. 555, 592 (2009)).
  185. Indian Brand Farms v. Novartis Crop Prot., Inc., 617 F.3d 207, 222 (3rd Cir. 2010).
  186. Ansagay, 153 F. Supp. 3d at 1281.
  187. Hardeman v. Monsanto Co., 997 F.3d 941, 950 (9th Cir. 2021), cert. denied, 142 S. Ct. 2834 (2022).
  188. Petition for Writ of Certiorari at 6, Hardeman, 997 F.3d, cert. denied, 142 S. Ct. (No. 21-241).
  189. Glyphosate is considered cancerous under California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65. CHEMICALS KNOWN TO THE STATE TO CAUSE CANCER OR REPRODUCTIVE TOXICITY, Cal. Env’t Prot. Agency Off. of Env’t Health Hazard Assessment 11 (Feb. 25, 2022), https:// oehha.ca.gov/media/downloads/proposition-65//p65chemicalslistsinglelisttable2021p.pdf.
  190. Michael Goodis, Glyphosate Registrant Letter, Off. of Chemical Safety and Pollution Control, EPA (Aug. 7, 2019), https://www.epa.gov/sites/default/files/2019-08/documents/glyphosate_registrant_letter_-_8-7-19_-_signed.pdf (“[P]esticide products bearing Proposition 65 warning statement due to the presence of glyphosate are misbranded pursuant to section 2(q)(1)(A) of FIFRA,” for false and misleading statement.).
  191. According to former Supreme Court Justice Stephen Breyer, the EPA should also be able to decide whether a state law imposes requirements in addition to or different from FIFRA. Bates v. Dow Agrosciences LLC, 125 S.Ct. 1788, 1804 (2005) (Breyer, J., concurring). The EPA made no such ruling in this letter. See Michael Goodis, Glyphosate Registrant Letter, Off. of Chemical Safety and Pollution Control, EPA (Aug. 7, 2019), https://www.epa.gov/sites/default/files/2019-08/documents/glyphosate_registrant_ letter_-_8-7-19_-_signed.pdf.
  192. Petition for Writ of Certiorari at 21, Hardeman, 997 F.3d, cert. denied, 142 S. Ct. (No. 21-241).
  193. 7 U.S.C. § 136(q)(1)(G).
  194. Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 101 (2008).
  195. Hardeman, 997 F.3d at 955.
  196. Id. at 959 (“When a label needs to be changed, the manufacturer has the responsibility to change the label by drafting and submitting the label to EPA for approval, 40 C.F.R. § 152.50(e), which EPA ‘shall’ approve if it determines the change will not violate FIFRA, § 136a(f)(1).”)
  197. Michael Goodis, Glyphosate Registrant Letter, Off. of Chemical Safety and Pollution Control, EPA (Aug. 7, 2019), https://www.epa.gov/sites/default/files/2019-08/documents/glyphosate_registrant_letter_-_8-7-19_-_signed.pdf (“[P]esticide products bearing Proposition 65 warning statement due to the presence of glyphosate are misbranded pursuant to section 2(q)(1)(A) of FIFRA,” for false and misleading statement.). See also Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 842 (1984).
  198. 7 U.S.C. § 136(q)(1)(G).
  199. § 136v(a), (b).
  200. “A State may regulate the sale or use of any federally registered pesticide or device in the State, but only if and to the extent the regulation does not permit any sale or use prohibited by this subchapter.” 7 U.S.C. § 136v(a).
  201. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005) (“If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly.”).
  202. Sharon Lerner, THE DEPARTMENT OF YES: How Pesticide Companies Corrupted the EPA and Poisoned America, The Intercept (June 30, 2021), https://the intercept.com/2021/06/30/epa-pesticides-exposure-opp/.