There is definitely a lot of information being shared concerning the latest glyphosate verdict and legal developments in State of Georgia. I’ll have more to say on the billion-dollar Barnes verdict soon, but it is worth noting that—almost at the same time—legislation similar to what is being proposed at the federal level just passed in that state.
Once again, I would be cautious against relying on social media for accurate information. I’m pretty firm in my belief that these state-by-state preemption efforts are a significant miscalculation. A national approach makes sense, but understanding why takes a bit more mental acuity than just shouting about ‘shielding’ and ‘immunity,’ even if that is the intent. Today is the deadline for comments to an EPA docket that seeks to amend FIFRA.1 I submitted a comment in support of the petition back on Feburary 19th prior to the current extension.
The petition is a step forward in clarifying Congressional intent and promoting uniformity in pesticide labeling. It does this by clarifying the definition of "misbranding" but I believe it should go further by referencing additional federal code sections—such as Section 502 of the Federal Food, Drug, and Cosmetic Act (FFDCA)—to ensure full regulatory alignment.
One key issue I identified is that the term 'likelihood' in regulatory language lacks precision and clarity. I proposed replacing this term with 'risk,' as providing a more scientifically grounded and meaningful term that emphasizes the importance of quantitative risk assessments.
The Need for National Uniformity in Pesticide Labeling
At the heart of my comment is the importance of national uniformity in safety labeling. The best available science must guide labeling decisions, ensuring that warnings are clear, accurate, and consistent. Without a standardized approach, state-by-state labeling could create a fragmented, unpredictable regulatory landscape, which poses significant challenges—not just for businesses, but also for consumers and regulatory agencies. Crossing a state line should not alter the safety or risk of a product. Interstate commerce is important, and drugs safety and efficacy data really shouldn’t change by geographic or political position. Ultimately, inconsistencies lead to unnecessary litigation, increased judicial intervention, and a diversion of valuable resources.
It’s important to emphasize that this petition does not seek to create a "liability shield" for pesticide manufacturers. FIFRA registration does not absolve companies of liability. Congressional intent is clear—as reflected in Section 136v(b) of FIFRA titled ("Uniformity")—that pesticide labeling requirements should be consistent across all states. Court cases, such as Schoenhofer v. McClaskey (10th Cir. 2017),2 reinforce this, affirming that national uniformity is a statutory requirement.
The Consequences of a State-by-State Approach
For clarification, "the registration of a pesticide does not constitute a defense to liability." As I carefully outlined, the current state-by-state regulatory approaches designed to circumvent liability ultimately undermine the strongest legal argument, that in favor of national uniformity.
The state-by-state approach undermines the federal preemption argument and invites legal scrutiny — you can’t have it both ways. The state-level regulations clearly appear to be designed not as legitimate regulatory adaptation, but rather an attempts to circumvent accountability—that directly conflicts with Congressional intent.
My comment touched several areas that you need to think about before adjuciation and rulemaking. I’ll try to be brief in a few areas here…
A Brief History of FIFRA and FFDCA
First, to understand the current regulatory landscape, you must consider its evolution. Early pesticide regulations focused primarily on registration requirements. FIFRA through the Federal Environmental Pesticide Control Act of 1972 (FEPCA), placed greater emphasis on national uniformity.
Later, the Food Quality Protection Act (FQPA) of 1996 involving FIFRA, strengthened federal authority, requiring the EPA to establish a "reasonable certainty of no harm" standard from pesticide residues in food. This shift significantly limited individual states' ability to impose stricter regulatory standards that diverge from federal determinations.
Glyphosate as a Case Study
Litigation surrounding glyphosate does serves as a prime example of the broader challenges posed by inconsistent federal and state regulatory assessments. Discrepancies in risk evaluation methodologies and conflicting regulatory determinations have led to significant litigation. I felt that the AGs petition here was rather poor and I added some references and important legal events that were omitted to illustrate the complexities of this issue.
Examining the IARC Monograph Program
Another critical issue raised in my review is the role of Monograph Program in pesticide litigation. I have serious concerns as to how the monograph findings should be used as legal evidence in US courtrooms considering Federal Rules of Evidence.3
These concerns include:
The monograph program does not assess all available data, potentially leading to biased conclusions.4
The program lacks competency in quantitative risk characterization, which is essential for regulatory decision-making.5
Its methodology relies on subjective, non-quantitative criteria, rather than established risk assessment frameworks.6
It lacks the transparency and scientific rigor expected of regulatory agencies.7
In 2018-2019, the elimination of the category "Probably NOT carcinogenic to humans" which is Group 4, raises further questions about its classification process and mission.8 Others have added that the scientific and political maneuvering surrounding glyphosate evaluation that further undermines confidence.
Compounding these concerns for legal proceedings is that more recent regulatory decisions from agencies worldwide—which have conducted comprehensive analyses incorporating all available data—have been disregarded as "foreign" and at times excluded as evidence.
Let’s add more conflicting information as to cancer warnings…
The Duty to Warn and California's Proposition 65
Beyond evidence and probabilities of cancer causation, the duty to warn plays a significant role in pesticide litigation. Companies must fulfill this legal obligation through EPA pre-registration and product stewardship. However, California’s Proposition 65 adds extra state-level requirements, partly based on classifications from the monograph program as an authoritative body.
When the State of California sets "safe harbor" levels—such as Non-Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs)—these thresholds are state-specific and do not align with federal determinations. These inconsistencies create conflict and are illustrative of the difficulty of determining when a duty to warn exists and is legally required. This gets complicated, but it is both legally and generally accepted that when exposures fall below established NSRLs - a warning label is not required.9
The Role of the Administrative Procedures Act (APA)
Now, I must again emphasize the importance of the Administration Procedures Act (APA) here. Regulatory clarity here depends on an understanding when the force of law exists behind agency actions. This can occur at both state and federal levels. Actions following notice-and-comment processes should carry more weight than informal guidance documents or letters. This means that ‘Dear Registrant Letters, and correspondence between State of California and EPA do not constitute policy but may only signal agency intent. Rulemaking is important. Sadly, today we are seeing rulemaking and the rule of law being disparaged (e.g., the "Richardson Waiver," a policy established in 1971).10
In my opinion, many EPA actions, including guidance documents, proposed rules, and letters, do not carry the full force of law—a reality that has become even clearer in the aftermath of Looper-Bright and similar legal challenges - as I’ve discussed in previous posts.
Beyond Cancer Risk—Addressing Knowledge Gaps
As a CYA, it must be said that while much of this discussion has focused on cancer risk, the broader toxicological profile of glyphosate warrants ongoing scrutiny. Despite conclusions from EFSA and ECHA that glyphosate is not carcinogenic, mutagenic, or reprotoxic, certain knowledge gaps in human health assessments remain. These should be carefully examined as new research emerges.
The Federal Government's Compelling Interest
To close - my thoughts underscore that a there is a compelling federal interest in ensuring uniformity in pesticide labeling. The sheer prevalence of glyphosate, the billions of dollars in litigation settlements, and the continued evolution of scientific research all highlight the critical need for clear, science-based regulations that prevent regulatory fragmentation and legal uncertainty.
Additionally, potential conflicts of interest among key policymakers—including the Director of Human Health Services—further complicate the regulatory landscape. EPA must retain competency and federal oversight. A science-driven, uniform approach is the best way to protect public health and the environment, ensure business stability, and uphold the integrity of federal regulatory frameworks.
[audio stops here]
Seleted Quotes from the Filing
My Full Comment is available and posted to the EPA site at the follow URL. https://www.regulations.gov/document/EPA-HQ-OPP-2024-0562-0001/comment?filter=m7a-xgkt-j9p8 - Dated: February 19, 2025 Subject: Analysis of Petition to Amend FIFRA Regulations on Misbranding and the Broader Issue of Uniformity in Pesticide Labeling, Source: Comment by Brian H Mathison PhD on Petition Modifying 40 CFR 156.10(a)(5), Prepared for: [Intended Audience - e.g., Internal Stakeholders, Regulatory Analysts] - the following quotes were extracted by two separate AI frameworks.
"The petition to amend 40 CFR 156.10(a)(5) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) represents a positive step toward clarifying Congressional intent and promoting uniformity by further defining ‘misbranding’." (Page 1)
"However, the petition or docket should also reference additional federal code sections that further define ‘misbranding’ to ensure comprehensive regulatory alignment." (Page 1)
"Replacing 'likelihood' with 'risk,' where appropriate, could reduce ambiguity and improve the precision of regulatory language leading towards an understanding of quantitative risk assessments that are more informative." (Page 1)
"The United States has a vested interest in harmonizing safety labels by utilizing the best available science to provide clear, accurate, and consistent warnings for consumers." (Page 1)
"Disparate state-level labeling requirements would create a fragmented and inconsistent regulatory landscape; a chaotic environment, characterized by unpredictability poses substantial challenges for businesses, consumers, and regulatory agencies leading to increased litigation and judicial intervention diverting valuable resources. Therefore, consistent and uniform labeling standards are in the best interests of the United States." (Page 3)
"The title of Section 136v(b), labeled “Uniformity,” clearly signals Congress's intention to ensure that pesticide labeling requirements would be consistent across all states, thereby avoiding a patchwork of state regulations." (Page 4)
"For labeling 'the statute requires national uniformity.'" (Schoenhofer v. McClaskey, Page 4)
"This petition has merit, as uniform national standards serve both science and society. A state-by-state approach to avoid litigation undermines federal preemption and risks judicial scrutiny, especially post-Looper-Bright." (Page 4)
"Effective July 1, 2018, OEHHA adopted a No Significant Risk Level (NSRL) for glyphosate of 1100 micrograms per day. Exposures below the safe harbor NSRL do not require a Proposition 65 warning." (Page 17)
"Allowing individual states to impose labeling requirements that deviate from federal standards creates a fragmented and potentially conflicting regulatory landscape. Such inconsistencies undermine the purpose and efficacy of federal regulation, impose undue burdens on businesses and consumers alike, and ultimately compromise the goal of effectively protecting public health and safety." (Page 8)
"By enforcing preemption, the federal government ensures a coherent, science-based regulatory structure that fosters national consistency, promotes public confidence, and prevents the chaos of a fragmented legal landscape." (Page 20)
Conclusion:
ChatGPT and Google NotebookLM - analyzed my comment as follows:
The author strongly supports the petition's aim to clarify 'misbranding' under FIFRA and emphasizes the critical need for national uniformity in pesticide labeling. The document provides historical and legal context for this position, using the glyphosate litigation and California's Proposition 65 as illustrative examples of the challenges posed by inconsistent state regulations. The author raises significant concerns about the reliance on IARC monographs in US legal proceedings and underscores the importance of adhering to sound scientific principles and the APA in regulatory actions. Ultimately, the document argues that federal preemption in pesticide labeling is essential for a consistent, science-based regulatory framework that protects both public health and the interests of businesses.
REFERENCES - LINKS
40 CFR 156.10(a)(5)
The legal reference for the case is Schoenhofer v. McClaskey, 861 F.3d 1170 (10th Cir. 2017). In this case, the Tenth Circuit Court of Appeals affirmed the district court's decision, ruling that a Kansas Department of Agriculture regulation requiring excessive pesticide treatment in preconstruction applications was neither expressly nor impliedly preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Federal Rules of Evidence 702 - https://harvardlawreview.org/print/vol-138/federal-rule-of-evidence-702
International Agency for Research on Cancer (IARC). (2006). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Preamble. Retrieved from https://monographs.iarc.fr.
Report of the IARC Advisory Group To Recommend On Quantitative Risk Characterization, INTERNAL REPORT 14/001, 18–19 November 2013 Chaired by Christopher Portier (LINK) [page 6] Regarding Quantitative Risk Characterization (QRC) “If IARC wishes to pursue QRC to the point of developing risk estimates, combining these risks with exposures and predicting cancer burden, additional resources will need to be committed by the Agency to accomplish this goal. Establishing partnerships with other groups with expertise in QRC would also help in achieving this goal.”
U.S. Environmental Protection Agency (EPA). (2009). Risk Assessment Guidelines for Superfund: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment). EPA 540-R-99-005. U.S. Environmental Protection Agency. Retrieved from https://www.epa.gov/superfund/risk-assessment.
AND
Becker RA, Dreier DA, Manibusan MK, Cox LAT, Simon TW, Bus JS. How well can carcinogenicity be predicted by high throughput "characteristics of carcinogens" mechanistic data? Regul Toxicol Pharmacol. 2017 Nov;90:185-196. doi: 10.1016/j.yrtph.2017.08.021. Epub 2017 Sep 1. PMID: 28866267. (LINK) [Open Access] “Using the same assignments as IARC of ToxCast/Tox21 assays to the seven key characteristics of carcinogens, the ability to predict cancer hazard for each key characteristic, alone or in combination, was found to be no better than chance.”
Causes and prevention of cancer - The International Agency for Research on Cancer (IARC) is focused mainly on identifying substances that cause cancer, however, this focus has a limitation—it doesn’t consider substances that could prevent cancer, known as anticarcinogens. This narrow focus on harmful agents means IARC doesn’t explore protective factors like certain foods, vitamins, or lifestyle choices that can reduce cancer risk. Research has shown that antioxidants, for example, or specific dietary habits might help prevent cancer, but IARC’s mission doesn’t include evaluating these potential cancer-fighting agents. By failing to consider cancer prevention strategies alongside cancer-causing agents, IARC’s work misses an important part of the equation. Cancer prevention isn’t just about eliminating harmful exposures; it also involves promoting protective substances and behaviors that can lower cancer risk. As a result, IARC’s recommendations may not provide a full range of strategies for public health.
In summary, while IARC plays a vital role in identifying carcinogens, its limited focus on anticarcinogens—acknowledging the difficulty of defining such substances within regulatory guidelines—restricts its ability to provide a more comprehensive approach to cancer prevention. A more balanced strategy would consider both harmful exposures and protective agents to more effectively reduce cancer risk. However, it’s important to note that some chemicals may challenge traditional categorization, as they could act both as carcinogens and anticarcinogens, adding complexity to this issue. (LINK)
Much of the CCR citations are in a previous comment - https://oehha.ca.gov/comments/comment-submissions-notice-modification-proposed-regulation-safe-harbor-warnings-glyphosate-and/comment-20763-brian-h-mathison
This referes to the Department of Health and Human Services' (HHS) rescission of the "Richardson Waiver," a policy established in 1971. This waiver voluntarily subjected certain HHS rules—specifically those related to agency management, personnel, public property, loans, grants, benefits, or contracts—to the notice-and-comment rulemaking procedures outlined in the Administrative Procedure Act (APA), despite the APA exempting such matters from these requirements. The APA's exemption is found in 5 U.S.C. § 553(a)(2), which excludes these categories from its notice-and-comment mandates.
On February 28, 2025, HHS issued a Policy Statement rescinding the Richardson Waiver, thereby aligning its rulemaking practices with the APA's original exemptions. This change grants HHS greater flexibility in issuing rules without undergoing the notice-and-comment process for the specified categories, unless otherwise required by law.
ALSO
HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe https://www.hhs.gov/about/news/2025/03/10/hhs-secretary-kennedy-directs-fda-explore-rulemaking-eliminate-pathway-companies-self-affirm-food-ingredients-safe.html
Share this post