By: Charles Benbrook, Strategic Advisor, Heartland Health Research Alliance (HHRA) Updated May 27, 2026 To view the entire post as a PDF, click here. To read the full HHRA brief submitted to the Supreme Court, click here. To read HHRA’s press release on why the brief was submitted, click here. The Supreme Court agreed to hear an appeal of the plaintiff verdict in the John Durnell versus Monsanto non-Hodgkin lymphoma (NHL) cancer case that had been tried in the State of Missouri.  The issue before the Court is stated on the SCOTUS website as: “Whether the Federal Insecticide, Fungicide, and Rodenticide Act preempts a label-based failure-to-warn claim where EPA has not required the warning.” The appeal challenged the “failure to warn” cause of action in the Durnell v. Monsanto case involving Roundup and NHL on the grounds that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts (overrules) state-law based “failure to warn” claims.  Bayer/Monsanto’s appeal asserts that because federal EPA did not require Monsanto to add a cancer warning on the label of the Roundup products bought by Mr. Durnell, the judge in that trial should not have allowed the jury to consider the “failure to warn” cause of action. Durnell’s defense is that both federal and state law prohibit the sale of a pesticide with a false or misleading label—meaning the requirements are identical and nothing is preempted.  As the plaintiff verdict in Durnell progressed through the appeal process, and eventually reached the SCOTUS, the primary justification advanced by lawyers for Bayer/Monsanto was that Monsanto could not add a cancer warning onto the Roundup products sold in Missouri, because doing so would impose an added, state-law driven labeling requirement that was “in addition to” the provisions contained in the EPA-approved Roundup label.  The Bates v. Dow Agrosciences (2005) decision established existing SCOTUS precedent governing failure to warn claims. In that ruling, the Supreme Court determined that as long as state law parallels federal requirements, it is not preempted.  The key question at the heart of this case and other pesticide preemption cases has become whether a pesticide product can be registered and still “misbranded” under FIFRA. A pesticide product is “misbranded” if its labeling, when adhered to, fails to avoid “unreasonable adverse effects on man or the environment”.  If the Supreme Court holds that a registered pesticide with an EPA-approved label can nevertheless be misbranded, then a state-law based misbranding claim would not be in addition to what is required by FIFRA for two reasons:  First, the requirement to avoid “unreasonable adverse effects” is shared, or common, under FIFRA and state law, and  Second, FIFRA states that federal registration (i.e. an approved EPA label) “shall not be a defense” against misbranding.  If the justices follow this logic, then Durnell should stand.  If the justices are persuaded that EPA’s registration decision forecloses a finding that the product is misbranded, then Monsanto will likely win. In recent years, the preemption defense has been advanced, and rejected, in most pesticide liability cases involving Roundup and NHL, paraquat and Parkinson’s disease, and other pesticide litigation involving: An adverse human health outcome,  Unacceptable product performance, or  Collateral economic damage (e.g. herbicide carryover and damage to a subsequent crop, pesticide drift, harm to personal property like honey bees or livestock). Appearances in Durnell v. Monsanto during oral argument were made on behalf of petitioner Bayer/Monsanto by Paul Clement; by Sarah Harris on behalf of the government and in support of Bayer/Monsanto; and, by Ashley Keller on behalf of respondent, Mr. John Durnell. I attended the oral argument and offer these comments on key passages and points that arose during the oral argument. An effort is made to explain the relevance of references made to prior SCOTUS cases and rulings that were a primary focus throughout the oral argument. Thanks to Daniel Hinkle, Senior Counsel for Policy and State Affairs of the American Association for Justice, for assistance in explaining the relevance and impact of prior SCOTUS cases and rulings.  Below you will find comments made in response to certain passages in the Durnell v. Monsanto Oral Argument transcript identified by page and line number. Access the full transcript at:  https://www.supremecourt.gov/oral_arguments/argument_transcripts/2025/24-1068_fcgj.pdf   The Oral Argument In his brief opening statement, Mr. Clement claims that FIFRA preempts state-law based failure to warn claims via the “express terms of FIFRA” that “forecloses state labeling claims that are in addition to or different from those imposed by FIFRA.” He claims that arguing otherwise “defies common sense” and cites the Court’s 8-1 judgment in Riegel v. Medtronic (2008). In the Riegel v. Medtronic case, a patient was injured when an FDA-approved heart catheter burst. Mr. Riegel sued Medtronic under state law. The Supreme Court ruled 8-1 for the manufacturer. SCOTUS concluded that once the FDA approves a medical device through its rigorous premarket review process, state juries can’t impose new or different requirements by holding medical-device manufacturers liable under state tort law.  A key factor leading to the Riegel v. Medtronic ruling was the wording in the Medical Device Amendments, which explicitly preempts any state-law requirement that is “different from, or in addition to” federal requirements (such “explicit”, or stated preemption, is termed “express” preemption in court proceedings). In Riegel, the federal approval sets the requirements and expressly preempts state law. Mr. Clement and Monsanto argued that FIFRA works the same way:  FIFRA’s explicit preemption provision prohibits state-law requirements that are “different from, or in addition to” those requirements imposed by FIFRA;  Registrants must use label language that the EPA has approved, and cannot unilaterally make substantive changes in most label provisions;  The EPA had approved Roundup labels without a cancer warning, and therefore; A Missouri jury saying “you should have added a cancer warning” is a state requirement “in addition to” what EPA decided was necessary and, therefore, is preempted.  However, as the Durnell case moved through the appeals process and during the SCOTUS oral argument, counsel for Mr. Durnell argued that this line of argument, and the Court’s reasoning in Riegel, does not apply […]

Press Release Amicus Brief Highlights “Unintended Consequents” If the Court Rules in Favor of Bayer/Monsanto and the Pesticide Industry HHRA warned the Supreme Court that “the effectiveness of FIFRA [federal pesticide law] rises and falls on the fluidity and coherence of state plus federal contributions to labeling” in an Amicus Brief submitted today. The Court is scheduled to hear oral arguments April 27th on a controversial pesticide preemption case that could make it harder for citizens to sue pesticide manufacturers when one of their products does not work as claimed, or triggers an adverse health outcome. Preemption would also dramatically reduce the role states are currently playing in pesticide regulation, while placing new burdens on EPA at a time the agency is dealing with steep budget cuts. “Something has to give, and here in Iowa, we fear it will be public health and environmental quality,” warned Audrey Tran Lam, an HHRA Board member and Director of the Pesticides and Public Health Working Group at the University of Northern Iowa. If the Court rules in favor of Bayer/Monsanto, pesticide registrants and the EPA will determine what risks are acceptable and how pesticides can be used in farming and non-agricultural settings. “Pesticides are invaluable tools for managing pest risks to agriculture and public health,” reports Dr. Thomas Green, chair of HHRA’s Board of Directors. “Pesticide use can also generate risks. I’ve spent my career working with all sectors to reduce pest management risks and optimize benefits. Tremendous progress has and continues to be made. However, history is littered with examples of where manufacturers developed products and regulators approved uses that later were discovered to carry unacceptable risks. At times like today when the pesticide industry has so much clout at EPA, shielding the industry from legal action, a key disincentive for overlooking risks, does not bode well for farmers, people who handle and apply pesticides as part of their jobs, the public or the environment.” For years the pesticide industry has sought changes in pesticide law to shield registrants from liability and litigation when a product fails to work as advertised or makes someone sick. The Department of Justice has joined the pesticide industry in arguing before SCOTUS that as long as an applicator follows the instructions on an EPA-approved label, the manufacturer should not be liable for a failure to warn about adverse effects or economic losses. “If the Court accepts the industry’s argument, all registrants will have to do is gain EPA approval of bare-bone labels that lack needed warnings and requirements,” explained Dr. Charles Benbrook, HHRA founder and strategic advisor, and author of the Brief. HHRA points out to the Court the two major reasons why the industry is so determined to put a liability shield in place. First, advances in science are connecting the dots between pesticide exposures and disease outcomes. And second, since the 1990s, the pesticide industry has become increasingly able to influence how senior officials in the Office of Pesticide Programs (OPP) “balance” pesticide risks and benefits. The Brief’s “Summary of Argument” section closes by stating: “The Court should not solve Bayer/Monsanto’s near-term, litigation-driven fiscal crisis via expanding the scope of preemption, thereby creating more consequential problems that will plague U.S. farmers and pest managers, the general public, and regulatory officials for many years, if not decades.” For More Additional materials on preemption are on HHRA’s website, including March 2025 HHRA comments to EPA on a preemption petition submitted to the agency by 11 Attorneys General. To schedule an interview with Dr. Thomas Green or Dr. Benbrook, email info@HH-RA.org or call 262-844-0200.

Defining and Delineating Ultra-Processed Foods  These comments are submitted on behalf of the Heartland Health Research Alliance (HHRA), a non-profit organization conducting research on the impacts of farming systems on the environment and public health (hh-ra.org), and the Swette Center for Sustainable Food Systems at Arizona State University. HHRA and the Swette Center submitted comments dated July 15, 2025 to the FDA on its proposed front-of-package nutrition labeling system. In February, 2023, HHRA and the Swette Center submitted comments to the FDA on the definition of “healthy” food and related measurement challenges. In our 2023 comments, we recommended adoption of novel metrics to quantify food nutritional quality as part of an analytical system called NuCal; two co-authors of these comments (Benbrook, Mesnage) published a paper describing NuCal in 2024. The co-authors of these comments on ultra-processed foods are (alpha): Mr. Dan Barber, Chef and Co-Owner, Blue Hill Restaurant at Stone Barns. Dr. Charles Benbrook, former Executive Director of HHRA. Anne Biklé, science writer who, with David Montgomery, authored What Your Food Ate: How to Heal Our Land and Reclaim Our Health (2022). Dr. Asa Bradman, University of California, Merced and member of the HHRA Board of Directors. Dr. Steven Chen, Chief Medical Officer of the Recipe4Health, a food-as-medicine program in Alameda County, California. Dr. Donald R. Davis, retired nutrition scientist who has conducted extensive research on historical changes in food nutrient content. Mr. Alan Lewis, Vice President for Government Affairs, Stakeholder Relations, and Organic Compliance at Natural Grocers. Dr. Kathleen Merrigan, Executive Director of the Swette Center, Chair of HHRA’s Public Policy Advisory Committee, and former USDA Deputy Secretary. Dr. Robin Mesnage, scientist conducting genomics and metabolic research on food safety and nutritional quality at the Buchinger Wilhelmi Clinic in Uberlinger, Germany. Mesnage and HHRA science advisor. Dr. David Montgomery, professor of geomorphology at the University of Washington in Seattle, and expert on how soil health impacts food nutritional quality and human health. Ms. Mary Purdy, MS, RDN, Managing Director of the Nutrient Density Alliance and Adjunct Faculty at the Culinary Institute of America. Mr. Bob Quinn, PhD, founder of Kamut International, and an organic farmer in Montana who has recently founded a regenerative organic research institute on a portion of his farm. Dr. Adam Shriver, Director of Wellness and Nutrition at the Harkin Institute at Drake University in Des Moines, Iowa. Dr. Andrew Smith, Chief Scientific Officer of the Rodale Institute. Mr. Tom Willey, retired California organic farmer and host of the “Down on the Farm” podcast. Access to multiple documents drawn upon in the preparation of these comments is provided via hyperlinks in the text. Citations to published papers appear in “References”.   Table of Contents I. Summary and Key Recommendations. II. Why Define, Measure, and Label Food by Degree of Processing? A. Evidence Linking Processed Foods to Adverse Public Health Outcomes Has Not Been Matched by Efforts to Reverse the Decline in Food Quality and Safety. B. Classifying Foods by Degree of Processing. 1. Food-as-medicine Programs Bring New Focus on Food Nutritional Quality. 2. A Key Challenge Confronting the FDA and USDA. C. Terminology and Focus. III. Taking Account of Food Manufacturing in Delineating the Degree of Processing A. Key Concerns and Metrics Needed to Identify UPF. 1. What’s Lost? 2. Nutritional Quality Should be the Bedrock Metric. 3. What’s Added? 4. New Risks? B. Classifying the Degree of Processing in Food Products. 1. Generic Food Processing Classification Criteria Applicable to All Products. 2. Food Group Specific Criteria Needed in Classifying the Impacts of Processing. C. Vetting the System to Achieve Continuous Improvement. IV. Questions Posed by the FDA-USDA. A. Supporting Cohesive Research, Continuous Improvement, and Consistent Guidance to Consumers B. Responses to Questions 1-5 Posed by the FDA-USDA. V. Conclusions and Recommendations. References.   I.             Summary and Key Recommendations Improving the safety and nutritional quality of ultra-processed foods (UPF) is among the most promising — and attainable — options to enhance the health of the American public. Doing so will require major changes in policy, technology, consumer awareness, and market dynamics. Manufacturing and selling unhealthy UPFs is profitable and accepted in the US. For this reason, chronic diseases rooted in unhealthy food and dietary patterns, including metabolic syndrome, Type 2 diabetes, and cardiovascular disease, are undermining well-being. Health costs will also continue rising. We commend the FDA and USDA for seeking guidance on how to define and classify foods based on the impacts of processing. Government action will be essential to achieve meaningful improvements in public health. Left unchecked, current trends will exacerbate already serious health, policy, and fiscal crises. To turn the tide, manufacturing safe and nutritious UPF must become the most profitable option for the food industry. Forging consensus on how to define and measure the degree of processing is an essential first step. We argue this must be done through the lens of public health. Metrics used to measure the degree of processing in a finished food product must be grounded in changes in the nutritional quality and safety of food products, and ultimately, impacts on public health outcomes. Defining and classifying mostly whole and fresh foods is straightforward. The degree of processing in a finished processed food product, and its impacts on public health, should be determined as a function of: Nutrients and health-promoting phytochemicals that are lost or altered as a result of processing, What is added in recipes, or via processing technologies, and Whether, and to what extent, milling, oil extraction, other processing methods, and cooking creates new, or exacerbates existing, food safety hazards. The foundational metric should be the percentage loss of nutritional quality as a result of processing. Such a calculation should be made across all individual nutrients with a Recommended Dietary Allowance, or an equivalent daily intake benchmark required to sustain good health. The total amount of each essential nutrient in the raw ingredients required to manufacture a serving of processed food should be measured, just as the food industry now does for nutrients featured in […]

Multiple lines of evidence point to consumer food choices as major contributors to diet-related disease, and poor health and fitness. In a peer-reviewed journal article published today, authors Chuck Benbrook and Robin Mesnage cite studies indicating that “Some 90% of the estimated USD 4.3 trillion in annual health care costs in the US is triggered or made worse by poor food quality and diet-related disease.” Benbrook is the founder and former executive director of the Heartland Health Research Alliance (HHRA). The authors recommend novel metrics on both the nutrient density of food, and how to more accurately and usefully characterize the degree of food processing and its impacts on public health. The article is open access in the journal Foods and entitled “Enhanced Labeling to Promote Consumption of Nutrient Dense Foods and Healthier Diets.” The core nutrient density metric is a ratio: the percent of daily nutrient needs satisfied by a serving of food relative to the percent of a 2000 calorie daily diet taken up by the serving of food. This single metric is unmatched in comprehensively reflecting the nutritional quality of food. A graphic option to convey the metric on packaging is presented in Figure 3 in the new paper: A novel graphic is presented in Figure 5 to which integrates both the nutrient density and food processing metrics and graphics in a single graphic, shown below. The impacts of ultra-processed food (UPF) on public health outcomes is among the hottest topics in nutrition, medical, and public health journals, and media coverage on food quality and health outcomes. At the request of the journal, the authors developed a video abstract that explains the paper’s goals, methods, and key findings and recommendations. The authors conclude their paper with these observations: Transparent and accurate food product-specific ingredient and nutrient composition data should determine the content of nutrition health labeling. Efforts to soften the message should be resisted in light of the overwhelming need for new food labels that help bring about substantial improvements in food nutritional quality and dietary choices. Benbrook and Mesnage’s paper builds on public comments HHRA submitted in response to the US Food and Drug Administration (FDA) proposed rule in 2023 to update the definition of the term “healthy” on food labels. The proposed role would require foods labeled “healthy” to contain minimum amounts of foods recommended by USDA’s Dietary Guidelines, and to limit saturated fat, sodium, added sugar and other less healthy nutrients. Entitled “Food Labeling: Nutrient Content Claims; Definition of Term `Healthy’”, the comments recommended new  nutrition/health messaging on the front of food packaging. Co-authors of comments included the chair of HHRA’s Policy Advisory committee Dr. Kathleen Merrigan, HHRA science advisors, and other experts working on how changes in farming systems and technology can increase the nutritional quality of food: Dr. Hannah Flower, Dr. Donald R. Davis, Dr. David Montgomery and Anne Biklé. In the comments, the authors introduced “NuCal” as a name for their new system. Resources HHRA February 2023 comments to the FDA. Benbrook and Mesnage (2024). Enhanced Labeling to Promote Consumption of Nutrient Dense Foods and Healthier Diets, Foods. https://doi.org/10.3390/foods13213377 Video Abstract: “Enhanced Labeling to Promote Consumption of Nutrient Dense Foods and Healthier Diets”

HHRA and ORG-Tracker, represented by Dr. Chuck Benbrook and Dr. Brian Baker, submitted comments to the Agricultural Marketing Service at the USDA in advance of the National Organic Standards Board (NOSB) meeting in Portland, Oregon, from October 22nd to 24th, 2024. Drs. Benbrook and Baker will both attend the conference and deliver public comments. ORG-Tracker is a project carried out by HHRA. It aggregates pesticide residue data from inspections of organic farms carried out by certifiers. The tables generated by ORG-Tracker utilize the results of certifier testing to compare residue frequency and risk levels to food produced on conventional farms. The team is working to more effectively highlight gaps and challenges faced by certification agencies to answer questions like What crops should we be testing, and where? Is a pesticide residue found in an organic sample likely caused by accident, pesticide drift, or an intentional and illegal application? How can we modify organic programs to better mitigate risk? The comments delivered to the USDA discuss risk-based certification, pesticide residue testing, and policies impacting the incorporation of so-called inert ingredients in the biopesticides approved for use on organic farms. They argue for a more rigorous, comprehensive, and health-focused approach to risk oversight. Regarding residue testing, they advocate for more expansive and effective data aggregation to inform consumers and the organics community. Finally, for inert ingredients, they recommend further review of current policy, including increased transparency of ingredients in pesticide products. Thank you to Drs. Benbrook and Baker for your advocacy and hard work!   The three sets of comments are posted on HHRA’s website as part of our policy program: Comments to the NOSB on the Risk-Based Certification Discussion Document Under Consideration During the October 2024 Meeting in Portland, Oregon Written Comments on the NOSB Discussion Document “Residue Testing for the Global Supply Chain” Comments on the Inert Ingredients in Organic Pesticide Products Proposal dated August 13, 2024   Drs. Benbrook and Baker also submitted and presented comments at the Spring 2024 meeting of the NOSB, which are available on HHRA’s Policy and Regulatory Reform page.