Background 

            On Monday April 27 the U.S. Supreme Court will hear oral argument in Monsanto v. Durnell[1].  The case is a key component the campaign by Bayer AG, the owner of Monsanto, to put an end to the wave of pesticide tort litigation premised on the failure of Monsanto to adequately warn users of the risks of the herbicide glyphosate and its alleged carcinogenicity. The matter is not only the most significant pesticide related case since Bates v. Dow Agrosciences was decided in 2005 but holds potential implications for other regulatory regimes.

            The Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) states that “[A] state shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under FIFRA.[2] This provision was addressed by the U.S. Supreme Court in Bates v. Dow Agrosciences.[3] The Court clarified that state requirements include state tort common law. Nonetheless it held that while state labeling or packaging requirements that differed from those imposed by FIFRA are preempted, additional requirements that did not differ from FIFRA requirements were not preempted. It also held that other types of claims, such  defective design or breach of express warranty, were not labeling and thus not preempted.

            Since Bates Monsanto has faced tens of thousands of suits in state and Federal courts over the glyphosate lymphoma claims. Estimates are that Bayer has paid out in the range of $10 billion in the last five years. In February, 2026, Monsanto proposed a settlement of the majority of remaining cases for $725 billion. While proceedings related to the settlement offer are underway Monsanto continues to pursue the Durnell matter.   

            Monsanto lost the Durnell v. Monsanto[4]case in Missouri state court. Prior to that decision a split between the 3^rd and 9^thFederal Courts of Appeal laid the groundwork for Monsanto’s Petition for Certiorari, citing the Circuit split as justification for the Court to grant the petition.  In Hardeman v Monsanto Company[5] the 9^th Circuit Court of Appeals held that Hardeman’s failure to warn claim imposed duties consistent with FIFRA. In Schaffner v. Monsanto[6] the 3^rd Circuit Court of Appeals held that failure to warn claims are expressly preempted by FIFRA. With the encouragement of the U.S. Solicitor General the Court granted the Petition. In a recent order the Court allowed the U.S. to participate in the oral argument in support of Monsanto.

Broad Array of Parties Filing Amicus Briefs Anticipate Impacts of Decision Beyond FIFRA

            The wide range of parties filing amicus briefs in this case attest to the intensity of interest not only from the pesticide industry but other parties concerned with the broader issue of preemption by Federal law in other regulatory schemes.

            Monsanto has attracted support from a wide array of pesticide and agricultural organizations. These include CropLife America, the major agricultural chemical trade association, as well as the American Chemistry Council, a broad-based chemical trade association which includes a focus on antimicrobial pesticides.  The American Farm Bureau Federation, the largest agricultural trade association, joined a brief, as did eleven individual state Farm Bureau organizations[7]. Eleven other crop-based agricultural trade associations[8]also joined briefs.

            Other major trade associations not related to the pesticide industry have also filed briefs. These include the Chamber of Commerce and Pharmaceutical Research and Manufacturers of America, the trade association of major pharmaceutical manufacturers. This case is a rare instance of the Chamber of Commerce supporting rather than attacking EPA. A number of other lesser-known parties focused on “tort reform” have also filed in support of Monsanto, anticipating that a Monsanto victory would have an impact beyond the pesticide industry.

            The case has prompted competing briefs from collections of states both in support of preemption and opposed to it. Fifteen states, led by Missouri[9], filed in support of preemption. Fifteen other states and the District of Columbia filed in opposition to preemption.[10]  A separate brief opposing preemption was also filed by Texas, Florida and Ohio. It is noteworthy that the decision for a state to file an amicus brief is almost universally a decision of the state attorney general. That fact can lead to the anomalous circumstance wherein the attorney general is a member of one party and the governor is a member of another party and would likely take different positions. Pennsylvania is such an example, where the Democratic governor would be unlikely to support preemption but the Republican Attorney General does.

            A number of environmental and health advocacy organizations have filed briefs opposing preemption.  These include the Consumer Federation of America, the National League of Cities, the National Association of Counties, the Center for Biological Diversity, Public Citizen and Veterans of Foreign Wars, along with many other lesser-known entities. The lead law firms representing the plaintiffs in the multidistrict glyphosate and paraquat litigation also filed a brief.

            Glyphosate has played a key role in the “Make America Healthy Again” (“MAHA”) movement. Children’s Health Defense, the organization formerly led by Health and Human Service Secretary Kennedy, has filed a brief opposing preemption. This issue has caused friction within the MAHA movement, as Secretary Kennedy has supported EPA’s position supporting preemption.

            Several other briefs present unique insights into the controversy surrounding glyphosate. In a brief filed by Naomi Oreskes, PhD, and Alexander Kaurov, PhD, of Harvard University, the authors focus on their journal recent article[11] describing the undisclosed ghost writing by Monsanto of a 2000 article[12] long touted as a key support for the assertion that glyphosate is not a carcinogen.

            Another unusual brief opposing preemption was filed by eight former EPA senior staff involved for many years in administering the EPA FIFRA program. This group includes Lynn Goldman, a former Assistant Administrator overseeing FIFRA and Jonothan Cannon, a former EPA General Counsel. Their brief asserts based upon their years of managing the program that EPA never considered additional state warnings as violative of FIFRA.  This position of course contradicts the EPA’s present posture in the case.

Outlook

            The highly anticipated oral argument will be divided three ways. Monsanto is allotted twenty minutes, having conceded ten minutes to the U.S. Solicitor General at his request. Respondent Durnell’s counsel is allotted thirty minutes. The lead law firms representing the plaintiffs in the multidistrict glyphosate and paraquat litigation also sought to participate in the argument but the Court denied their motion.

            If Monsanto prevails, there is a strong likelihood that all the failure to warn suits will be dismissed, although not without a fight depending on the clarity of the opinion. Such an outcome could also prompt Monsanto to revoke the pending settlement offer. The scope of such an opinion will also reveal the precedential importance of the decision to other regulatory issues.

            If Mr. Durnell prevails, the tort litigation will continue if not expand, although not in the limited number of states that have passed legislation annulling failure to warn claims.

[1] Docket No. 24-1068

[2] 7 USC §136v(b)

[3] 544 U.S. 431 (2005)

[4] 707 SW 3d 828 (Missouri Supreme Court)

[5] 997 F.3d 9419^th (Cir. 2021)

[6] 113 F.4 364 (2024)

[7] Farm Bureau Organizations of California, Florida, Kansas, Ohio, Oklahoma, Oregon, Missouri, North Carolina, Tennessee, Texas, and Virginia

[8] American Soybean Association, American Sugarbeet Growers, Association, Cherry Marketing Institute, Florida Fruit and Vegetable Association, International Fresh Produce Association, National Association of Wheat Growers, National Corn Growers Association, National Cotton Council of America, National Sorghum Producers, North American Blueberry Council and Western Growers.

[9]Alabama, Georgia, Iowa, Kansas, Kentucky, Louisiana, Missouri, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, South Carolina, South Dakota and Utah.

[10] Arizona, California, Colorado, Delaware, Illinois, Massachusetts, Maine, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, Oregon and Wisconsin

[11] The Afterlife of Ghost-written Paper: How Corporate Authorship Shaped Two Decades of Glyphosate Safety Discourse ENVT.SCI & Policy 171 (2025).

[12] Safety Evaluation and Risk Assessment of the Herbicide RoundUp and Its Active Ingredient Glyphosate for humans REG. TOXICOLOGY & PHARM 31 (2000.)

       In a widespread campaign the pesticide industry is pursuing actions at the U.S. Environmental Protection Agency (“EPA”) and in the courts, the Congress and state legislatures seeking to establish label preemption that would eliminate failure to warn claims brought under state law. Prompted primarily by the successful suits against Monsanto alleging that Round Up® label failed to warn users that glyphosate, which was for many years the active ingredient in the herbicide Round Up®[1], causes non-Hodgkins’s lymphoma.

            The Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) states that “[A] state shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under FIFRA.[2] This provision was addressed by the U.S. Supreme Court in Bates v. Dow Agrosciences.[3] The Court clarified that state requirements include state tort common law. Nonetheless it held that while state labeling or packaging requirements that differed from those imposed by FIFRA are preempted, additional requirements that did not differ from FIFRA requirements were not preempted. It also held that other types of claims, such  defective design or breach of express warranty, were not labeling and thus not preempted.

Tort Litigation

            Despite the door seemingly left open by the Court in Bates, the pesticide industry had been under the impression that the decision would greatly limit future state law claims. The course of events since then has proven otherwise. Monsanto, now owned by Bayer, has faced tens of thousands of suits in state and Federal courts over the glyphosate lymphoma claims. Estimates are that Bayer has paid out in the range of $10 billion in the last five years.

            The leading victory for plaintiffs is Hardeman v Monsanto Company.[4] The 9^th Circuit Court of Appeals held that Hardeman’s failure to warn claim imposed duties consistent with FIFRA. It also upheld the District Court’s qualification of the plaintiff’s expert under the  test established by the Supreme Court in Daubert v. Merrell Dow Pharmaceutical.[5] Monsanto then filed a Petition for Certiorari with the Supreme Court. As it sometime does when a case implicates Federal law but the U.S. is not a party, the Court asked the U.S. Solicitor General for a recommendation as to whether the Court should accept the case. The Solicitor recommended against accepting the case and the Court did not.

            Subsequent to Hardeman, in a major victory for Monsanto, the 3^rd Circuit Court of Appeals in Schaffner v. Monsanto[6]held that failure to warn claims are expressly preempted by FIFRA. Seizing on this opinion, Monsanto filed a new Petition for Certiorari with the Supreme Court seeking review of Durnell v. Monsanto[7], a Missouri case which it lost. At the urging of the U.S. Solicitor General, the Court granted the Petition on January 16, 2026. The case will be argued April 27^th, indicating that a decision will be issued this term, which ends in June. In a recent order the Court allowed the U.S. to participate in the oral argument in support of Monsanto.

            An increasing number of tort actions have also been brought asserting that the highly acutely-toxic herbicide paraquat causes Parkinson’s disease. A series of actions have been consolidated under Federal Multidistrict Litigation procedures in the Southern District of Illinois[8]. The Court continues to extend deadlines while the parties engage in settlement discussions. There are also numerous state court paraquat actions proceeding, particularly in Pennsylvania. The same preemption issues are present in these cases, and proposed plaintiffs’ experts in these matters will face qualification hurdles. At the same time Syngenta, the original registrant of paraquat, has announced that it is ceasing production of the highly acutely toxic herbicide.

Congressional Action

            Congressional efforts have also been aimed at reducing or eliminating tort liability of pesticide registrants. A renewal of the so-called “Farm Bill[9]” contains several provisions related to pesticide regulation. It contains a preemption clause which tracks the relief sought by Monsanto from the Supreme Court.[10] It  also precludes local regulation of pesticides, thus reversing the holding in Wisconsin Public Intervenor v Mortier,[11] which held that under FIFRA as it presently exists the authority of local governments to regulate pesticides is a matter of state law. The House Agriculture Committee sent the bill to the full House on March 3, 2026.

            A provision was inserted as section 453 in the 2026 Interior and Environment 2026 appropriation bill which would bar the use of any appropriated funds:

“to issue or adopt any guidance or any policy, take any regulatory action, or approve any labeling or change to such labeling that is inconsistent with or in any respect different from the conclusion of (a) a human health assessment performed pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.); or (b) a carcinogenicity classification for a pesticide.

            While the impact of this proposed provision was uncertain, in the end advocates representing the so-called Make America Healthy Again (“MAHA”) movement succeeded in having this provision removed from the bill.

            In a diametrically opposed action. Senator Booker of New Jersey introduced the Pesticide Injury Accountability Act.[12] It would establish a Federal private right of action against a pesticide registrant for injury to person or property. The act would provide for punitive damages and declares that it would not preempt any state law claim.  The bill appears unlikely to proceed in the current Congress.

State Legislative Action

            Pesticide registrants have also been active on the state legislative front. Coordinated efforts have been directed at multiple states seeking the elimination of state tort claims, primarily failure to warn claims. North Carolina, Georgia and Kentucky have passed such legislation. The most public attention was directed to the proposal in Iowa, which failed, as did proposals in Florida, Mississippi, Minnesota, Oklahoma, Tennessee and Wyoming. If the Supreme Court rules for Monsanto, these enactments will become moot. If not, individuals in any states which enacted such legislation will have lost the right to sue while that right remains available in all other states.

EPA Petition

            The Attorneys General of the States of Nebraska, Iowa, Alabama, Arkansas, Georgia, Indiana, Louisiana, Montana, North Dakota, South Carolina, and South Dakota have filed a Petition[13] seeking to have EPA promulgate a rule declaring that “any state labeling requirements inconsistent with EPA’s findings and conclusions from its human health risk assessment on human health effects, such as a pesticide’s likelihood to cause cancer, birth defects, or reproductive harm, constitute misbranding under FIFRA.” It is likely to be months before EPA moves to solicit public input on the Petition.

Conclusion

            It is not clear how these conflicts will be resolved. Based upon the history of the prior cert denial and the present granting of a similar petition, the inference arises that the Court granted review in the Durnell case in order to strengthen preemption. Were that to occur it is highly likely that all the pending glyphosate and paraquat cases would be dismissed. If the Court rules against Monsanto, litigation will likely ensue over the scope of Congressional legislation.

[1] Glyphosate was since its market entry the active ingredient in all versions of Round Up®.  It is no longer the active ingredient in non-agricultural versions of Round Up®.

[2] 7 USC §136v(b)

[3] 544 U.S. 431 (2005)

[4] 997 F.3d 9419^th (Cir. 2021)

[5] 509 U.S. 579 (1993)

[6] 113 F.4 364 (2024)

[7] Missouri Supreme Court, No. SC100975

[8] Docket No. 3:21-md=3004

[9] The Farm, Food and National Security Act of 2026, H.R. 7567

[10] Section 10205.

[11] 501 U.S. 597 (191).

[12] S. 2324

[13] EPA-HQ-OPP-2024-0562 (filed August 7, 2024.)

            On February 6, 2026 the U.S. Environmental Protection Agency (“EPA”) issued a two-year registration for the so-called “over the top” (“OTT”) application of the herbicide Dicamba[1] to soybean and cotton crops genetically modified to be resistant to it. Four advocacy organizations[2] immediately filed a Petition for Review in the U.S. Court of Appeals for the 9^th Circuit.

            Dicamba was first registered in 1967.  Controversary regarding the product began in 2016 following the approval of its OTT use on crops genetically modified to be resistant to it[3]. The OTT use allows application to developing crops which themselves would be killed by the dicamba without the modification, in theory allowing greater control of late developing weeds. As a result of this new use the annual volume of dicamba nearly quadrupled to thirty million pounds by 2019.

            Problems were associated with the dicamba OTT use from its outset. Volatilization caused dicamba to be deposited on neighboring fields planted with non-GMO crops, causing extensive crop damage. The U.S. Department of Agriculture estimated that fifteen millions acres of soybeans were damaged.

            In National Farm Family Coalition v. U.S. EPA[4], the Court invalidated the dicamba registrations. It found that EPA had significantly understated the risk to the environment of unreasonable adverse effects. The Court also found that EPA had ignored other risks, including the likelihood that users would not follow the complicated label directions, that the product would have anticompetitive impacts in the soybean and cotton industries and that the controversial nature of the product would adversely impact the social fabric of farming communities. Although the registrations were revoked on June 8, 2020, EPA allowed product already in the channels of trade to be sold and used.

            The EPA Inspector General subsequently reported[5] that EPA had deviated from its standard procedures in reviewing dicamba pesticide registration applications. The Report found that EPA did not conduct the standard internal peer review of scientific documents created to support the decision to register dicamba for the OTT use. Furthermore it found that senior EPA officials altered documents, removing discussion of stakeholder risks.

            Following cancellations required by the 9^th Circuit decision, in October 2020, EPA again issued dicamba OTT registrations with a five-year life, adding new label directions and limitations on use. In 2022 EPA approved additional state-specific limitations for five states.[6]   

            These registrations were again challenged in Center for Biological Diversity v. EPA[7]. In a February 6, 2024 decision a judge in the District of Arizona revoked the 2020 registrations, including the state-specific label revisions, finding that EPA had neglected to engage in required notice and comment opportunities.

            In its ongoing effort to maintain OTT dicamba registrations, on February 6, 2026 EPA reissued the dicamba OTT registrations for an additional two-year period, stating that the new registrations reflect “the strongest protections in agency history”[8]. Additional requirements of the new registrations include cutting the application rate in half; requiring the use of additional volatility reduction agents in the tank mix; and mandating limitations on application during high heat conditions conducive to volatilization. 

            These conditions are in addition to the extensive conditions previously imposed. Those conditions include a 240-foot downwind spray drift buffer zone; prohibiting dicamba use where specific dicamba-sensitive crops are grown; limits on applications during specified wind speeds or when a temperature inversion[9] is occurring or anticipated; limits on spray droplet size and nozzle height; and a prohibition on aerial application. Other user requirements also apply, including that the applicator be certified and undergo annual training wear specified personal protective equipment.

            A Petition for Review was filed February 20, 2026 in the 9th Circuit.[10] Under the Petition Review process a simple notice is filed; the substance of the case is not presented until briefs are filed, a schedule for which has not yet been established.[11]

            It remains to be seen whether what is now the fourth dicamba related action will succeed as the prior three have. A focal point of the arguments likely will be whether EPA had properly characterized the drift hazards and whether the new use limitations will be deemed to have adequately reduced that hazard. To the extent that the 9^th  was previously concerned about users’ ability and willingness to understand and comply with the complex use directions it would appear that the new labels are even more complex and challenging. The cotton and soybean market impacts are not likely to be a major point of contention. What is likely the case is that by the time the 9^th Circuit issues a decision the 2026 use season will be underway and even if the 2026 registrations are revoked use will continue this growing season. 

[1] Dicamba is the common name for 3,6-dichloro-2-methoxybenzoic acid.

[2] National Family Farm Coalition; Center for Food Safety; Center for Biological Diversity; and Pesticide Action Network North America.

[3] The registrants of OTT dicamba are Bayer [formerly Monsanto], Corteva (formerly DuPont) and BASF.

[4] 960 F. 3d 1120 [9^th Cir. 6/3/2020].

[5] EPA Deviated from Typical Procedures in Its 2018 Dicamba Pesticide Registration Decision [Report 21-E-0146; 5/24/2121].

[6] Illinois, Indiana, Iowa, Minnesota and Sout Dakota.

[7] 2024 WL 455047; 2024 US DIST LEXIS 20307

[8] The EPA press release erroneously states that the dicamba OTT products have been “in continuous use” . That continuity was maintained only because the 9^th Circuit allowed product already in the channels of trade as of the revocation of the registrations  to continue to be sold and used.

[9] A temperature inversion is a meteorological condition wherein contrary to standard conditions a cooler air mass is capped by warmer air. The result can be among other effects the trapping and circulation of sprayed pesticides.

[10] 9^th Circuit Case No. 26-2021

[11] OTT dicamba registrant BASF has already filed a motion to become an intervenor-defendant.

          On June 25, 2025, ten environmental and farmworker advocacy organizations, including the Natural Resources Defense Council, the California Rural Legal Assistance Foundation, the Pesticide Action Network North Americas (“PANNA”) and the United Farmworker Foundation, filed a writ of mandamus action in the U.S. Cout of Appeals for the 9^th Circuit.[1] The plaintiffs seek to compel the U.S. Environmental Protection Agency (“EPA”) to issue a decision on a Petition filed by plaintiffs in 2022 which seeks greater limitations on the use of various organophosphate (“OP”) insecticides.

            The Petition names twelve ingredients as the OP products of concern.[2] EPA has recognized that the OP ingredients present a high risk of acute poisoning due to the decrease in cholinesterase when humans are exposed and the resultant impacts on the nervous system. There is also a growing body of data that indicates the OP products can have long term impacts on children who are exposed in utero.

            The Petition seeks to have  EPA (1) end all OP uses that EPA cannot find safe in food, drinking water, and spray drift; and (2) end all uses or put mitigation in place to protect workers and communities from unreasonable adverse OP risks. The Petition also asks EPA to develop a safety level that will protect children from neurodevelopmental harm, but not to delay protecting people from demonstrated harms using an acute poisoning endpoint while it does so. In addition, the Petition urges EPA to impose needed public health protections before it completes other legal obligations, which would take additional time.

            EPA had published a request for public comment on the  Petition on July 12, 2022.[3] Between 2015  and 2020 EPA completed preliminary risk assessments for eleven of the twelve ingredients, and had implemented various protective measures, but it had not made significant progress toward meeting the 2022 deadline for completing registration review. In 2022 Congress extended that deadline. EPA current projections are to completer registration review for three products by the end of 2025, seven products by the end of 2026 and two in 2027.  It was this extended schedule that prompted the filing of the writ.     

            Writs of Mandamus are rare and exceedingly difficult to obtain. Courts are reluctant to impose deadlines on agencies that are not reflected in statutes. EPA can be expected to argue that its limited resources will not allow it to complete the registration reviews sooner than scheduled. The Court may well sympathize with EPA give the resource strain it is under although the 9^thCircuit has previously imposed deadlines on EPA. It remains to be seen whether the passage of three years since the filing of the Petition and EPA’s extended schedule for completing the registration review of these products is sufficiently elongated so as to prompt the Court to order faster action. If the Court is inclined the next step would be to require EPA to decide the Petition within a certain time frame. If EPA denies the Petition the matter will be right back in the 9^th Circuit.

[1] Case 25-3955; U.S. Court of Appeals for the 9^th Circuit

[2] The ingredients are Acephate; Bensulide; Chlorethoxyfos; Diazinon; Dichlorvos/DDVP; Dimethoate Ethoprop; Malathion; Phosmet; Terbufos; Tribufos

[3] 87 Fed. Reg. 41310 (July 12, 2022.)

           The Make America Healthy Again Commission, established by Executive Order 14212[1], on May 22, 2025 issued its initial report entitled “The MAHA Report: Making Our Children Healthy Again”. The Report asserts that children in the US are experiencing a chronic disease crisis.  Four influences are alleged to be key drivers of adverse childhood health impacts: ultra processed foods; chemicals in the environment, impacts of digital life and social media; and overmedicalization.

            The Reports alleges that children are suffering from exposure to a plethora of toxins, including pesticides, heavy metals, air pollutants, endocrine disruptors, water borne contaminants such as PFAS, and persistent organics such as PCBs. There is widespread recognition that these are subjects of concern, although attitudes differ widely as to what remedial actions are warranted. There is less consensus regarding other cited topics of concern, including fluoride, cosmetics and exposure to 5G WiFi.

            Pesticides are the subject of the most extensive discussion regarding chemical exposures. The two primary points of attack on current regulatory approaches are the failure to evaluate pesticides on a multiple ingredient, cumulative basis and the reliance on allegedly biased industry conducted scientific studies. Data on the adverse health effects of glyphosate and atrazine are cited, but so is EPA’s conclusion that data does not identify any connection between glyphosate use and adverse health impacts.

            The proposed approach is a direct attack on existing law and EPA’s current process for evaluating the risks of harm from pesticides. FIFRA requires that data be generated by applicants for pesticide registration. The Report cites the legal reality that “a significant portion of environmental toxicology and epidemiology studies are conducted by private corporations.” The Report asserts that this circumstance is evidence of undue influence. The implication is that data supporting pesticide registrations, which the Report acknowledges run in the tens of millions of dollars, should be generated by government agencies. This position contradicts the Administration’s general policy position that private enterprise is more efficient than the government.            

             The Report contends that the administration will implement “gold standard” science and “radical” transparency. Executive Order 14303[2], entitled “Restoring Gold Standard Science” also bears on issues related to data supporting pesticide registrations and takes positions in conflict with existing law. The Executive Order asserts that all data relied upon by the Federal government must be peer reviewed and available for public review. This approach arguable presents a challenge to the current system supporting pesticide registrations, as data submitted in support of pesticide registrations is not peer reviewed nor is it available for public review. While criticizing the U.S. approach, the report flatly rules out modeling the practices of the European Union and its reliance on a “precautionary principle” which the Report alleges stifles growth.

            The Report has been attacked from multiple directions. Major agricultural trade associations, including the American Farm Bureau Federation, the National Corn Growers Association and the American Soybean Association have all issued critiques of the Report. On the other hand childhood advocacy organizations have criticized the fact that the Report makes no mention of firearms and automobile accidents, which are the two leading causes of childhood deaths. In recent years those two causes have been responsible for approximately 35% of annual childhood deaths. While the Report alleges that fluoride doses well beyond levels used in public water systems cause harm, it neglects to point out that tooth decay is the most widespread chronic health issue facing children.

            Further undermining the credibility of the Report has been the discovery that a number of citations in it do not exists or are incorrect. The inaccuracies include multiple instances where citations have been found to not exist, including instances where the citation included an obvious reference to having been generated by artificial intelligence. The Administration has issued two revised versions of the Report correcting and revising at least fifteen citations.

            Executive Order 14212 requires the Commission to issue a Strategy by mid-August. The Strategy will have to confront the explicit policy contradictions between the Report’s allegations of regulatory shortcomings and existing law and administration policy. The interests of the chemical and agricultural industries are likely to play a significant role in the shaping of the Strategy. The policy conflicts expressed in the Report will be playing out behind the scenes between now and the issuance of the Strategy.

[1] Published at 90 Fed Reg 9833 [May 29, 2025].

[2] Published at 90 Fed Reg 22601 [May 9, 2025].

            In an action brought by twenty trade agricultural associations and one registrant, the 8^th Circuit on November 7, 2023[1]ordered EPA to revisit its August 30, 2021[2] revocation of all chlorpyrifos tolerances, which thereby eliminated all food uses.

            Chlorpyrifos, once the most used insecticide in the U.S., has been the subject regulatory concerns for decades. It is a cholinesterase inhibitor, exposure to which can cause neurological harm. In 1997 EPA reached an agreement with the major chlorpyrifos registrants to reduce residential applications and exposure. Controversy continued about the extent of the risks presented by the product. The next major event was a petition seeking revocation of all food use tolerances filed by the Natural Resources Defense Council (“NRDC”) and Pesticide Action Network North America (“PANNA”) in 2007. Without a tolerance, which determines the residue level of an ingredient that is allowed in a food product, a product may not be applied to food crops.

            After years passed without a decision, NRDC and PANNA brought a mandamus action in the 9^th Circuit Court of Appeals seeking to compel EPA to issue a decision. In 2015 the Court issued a mandamus order requiring EPA to issue a decision on the petition and proposed tolerance revocations[3]. In April, 2017, EPA denied the petition and declined to revoke any tolerances[4]. Following an appeal of that order, EPA confirmed its position in 2019.[5]

            In 2020 EPA issued the Chlorpyrifos Proposed Interim Reregistration Review Decision. It found that chlorpyrifos did pose risks from certain uses and proposed to revoke certain tolerances.  After reviewing objections from various parties, EPA confirmed its decision.[6] That decision was challenged, and the 9^th Circuit Court ordered EPA to revisit the remaining tolerances.[7] EPA was given sixty days to either determine those uses that could be safely continued with appropriate tolerances or revoke all tolerances. EPA determined that it was not feasible in that timeframe to assess what uses could be safely continued and revoked all tolerances. The Red River Valley Sugarbeet Growers Association action was brought in response.

            The 8^th Circuit Court found that EPA’s decision to not retain specific tolerances which data suggested did not present unacceptable risks was arbitrary. The Court was not impressed by EPA’s determination that it did not have time to consider what tolerances to retain. It held that the short deadline imposed by the 9^th Circuit in League of Latin American Citizens v. Regan did not justify omitting any consideration of such acceptable uses which the law required EPA to do. The Court essentially said that EPA should have worked harder and faster.

            The Court has returned the issue to EPA to reconsider the entirety of its prior revocation order. EPA documents do suggest that if it had more time previously it would have considered retaining some tolerances, so such an action might well be taken. If so it would remain to be seen how the market accommodates the restoration of such uses. The tolerance revocation did not revoke or suspend the registration of chlorpyrifos products, but it would remain to be seen how the market would respond to the restoration of any uses. It is interesting to observe that the only registrant to join the 8^th Circuit action was Gharda, a generic registrant from India.   

            Reacting to the decision on February 2, 2024 EPA issued a Federal Register notice[8] reinstating the tolerances as directed by the Court. On March 15, 2024, EPA issued a product-specific notice regarding existing stocks, specifying the time periods in which products can continue to be used by growers.

            Chlorpyrifos remains under intensive review.  EPA is likely again to revoke numerous tolerances, while the product continues to undergo Registration Review.  Its future remains cloudy at best.

[1]Red River Valley Sugarbeet Growers Association et al v. Regan (8^th Cir. 2023 [No. 22-1422]).

[2] 86 Fed. Reg. 48315 (August 30, 2021).

[3] In Re Pesticide Action Network N. Am., 798 F.3d 809 (9^th Cir. 2015).

[4] 82 Fed. Reg. 16585 (April 5, 2017).

[5] 84 Fed. Reg. 35555 (July 24, 2019).

[6] 87 Fed. Reg. 112222 (Feb. 28, 2022).

[7] League of Latin American Citizens v. Regan, 996 F. 3d 673 (9^th Cir. 2021.)

[8] 89 Fed. Reg. 7625 (February 5, 2024.)

The new coronavirus SARS-CoV-2 continues to wreak havoc across the globe. According to the Johns Hopkins Virus Trackeras of this writing on April 1, 2020, there have been over 911,000 cases and over 45,000 deaths worldwide.  Rapid spread across the U.S. continues, with more than 203,000 cases and 4,400 deaths reported. New York has by far the greatest concentration of cases and deaths, accounting for approximately fifty percent of each.

In response to supply chain problems being encountered by disinfectant registrants, the U. S. Environmental Protection Agency (EPA) has now simplified procedures for substituting ingredients in disinfectants. Registrants are already permitted to switch sources of registered active ingredients by a process known as Notification. Such actions are governed by Pesticide Registration Notice 98-10: Notifications, Non-Notifications and Minor Formulation Amendments. Normally a registrant of antimicrobial products must wait sixty days after filing a notification before distributing an EPA-registered product subject to it, unless EPA approves the notification sooner. Even before the pandemic, EPA was overburdened and often was not responding to notifications for many months.

On March 30, 2020, EPA issued Temporary Amendment to Pesticide Registration Notice 98-10.  The Amendment makes two changes to the notification process. For a select group of active ingredients that EPA considers to be commodity chemicals, registrants may now utilize non-registered sources. Previously a change to an unregistered source required a formal amendment. In addition, registrants now may distribute product subject to the notification immediately upon filing it with EPA.

The ingredients subject to this new process are: Ethanol; Hypochloric acid; Sodium hypochlorite; Hydrogen peroxide; Hypochlorous acid; Citric acid; L-lactic acid andGlycolic acid.

The substituted ingredient must the specific version of the chemical as identified by EPA by Chemical Abstract Service (CAS) number and must meet the original certified limits specified on the product’s Confidential Statement of Formula (CSF). Registrants using non-registered sources may continue to do so as long as the Temporary Amendment is in force, which at this point is undetermined. If the registrant desires to utilize an unregistered source beyond the duration of the Temporary Amendment, a formal amendment to the CSF is required.

EPA continues to update list of registered disinfectants available for use on hard surfaces for the control of the novel caronavirus SARS-CoV-2, which causes COVID-19. See EPA List of Disinfectants for Control of SARS-CoV-2. EPA also continues to expedite reviews of amendments seeking to add claims for control of SARS-CoV-2, but only for products that already have approved claims for other emerging pathogens. See Guidance on Outbreak of Novel Coronavirus SARS-CoV-2. Registrants who wish to add claims for emerging pathogens for the first time must go through the standard amendment process.