By Lisa M. Campbell and Lisa R. Burchi
On November 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it was ordering Pool Water Products Inc. to stop selling an improperly registered pesticide, ALL CLEAR 3” Jumbo Chlorinating Tablets. The announcement states that even though the ALL CLEAR 3” Jumbo Chlorinating Tablets product was registered with EPA, Pool Water Products was selling and distributing an unregistered version of the product made in China that has not been evaluated by EPA.
EPA’s action, which it states applies to nationwide distribution, transport and sales of the product, follows a statewide stop-sale order issued earlier this month by the Arizona Department of Agriculture when state inspectors discovered the unregistered pesticide, which is used to disinfect pools, during an August 30 inspection of the company’s Phoenix warehouse.
This case exemplifies the need for companies to understand Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration and amendment requirements, and the importance that a product’s label, formula, and manufacturing process match exactly with the information submitted to EPA and upon which EPA relied in approving the registration. Many composition and processing changes require an amendment to be approved by EPA; failure to do so could result in an enforcement action such as this one.
More information on pesticide registration issues is available on our blog.
By Lisa M. Campbell, James V. Aidala, and Timothy D. Backstrom
On October 31, 2018, the U.S. Environmental Protection Agency (EPA) announced that it is extending the registration of dicamba for two years for “over-the-top” use (application to growing plants) to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba. EPA states that the registration for these dicamba products will expire on December 20, 2020, unless EPA decides to further extend it. EPA states that the label changes described below were made to ensure that these products can continue to be used effectively while addressing potential concerns to surrounding crops and plants. EPA’s dicamba registration decisions for the 2019-2020 growing season are:
- Two-year registration (until December 20, 2020);
- Only certified applicators may apply dicamba over-the-top (those working under the supervision of a certified applicator may no longer make applications);
- Prohibit over-the-top application of dicamba on soybeans 45 days after planting and cotton 60 days after planting;
- For cotton, limit the number of over-the-top applications from four to two (soybeans remain at two over-the-top applications);
- Applications will be allowed only from one hour after sunrise to two hours before sunset;
- The downwind buffer for all applications will remain at 110 feet, but in those counties where endangered species may exist, there will also be a new 57-foot buffer around the other sides of the field;
- Clarify training period for 2019 and beyond, ensuring consistency across all three products;
- Enhanced tank clean out instructions for the entire system;
- Enhanced label to improve applicator awareness on the impact of low pH’s on the potential volatility of dicamba; and
- Label clean up and consistency to improve compliance and enforceability.
EPA states that it has reviewed substantial amounts of new information and has determined that the continued registration of these dicamba products with the specified use restrictions meets the Federal Insecticide, Fungicide, and Rodenticide Act’s (FIFRA) registration standards. EPA also determined that extending these registrations with the new safety measures will not affect endangered species. More information on this extension is available on EPA’s website; more information on other dicamba issues is available on our blog.
As expected, this decision allows the continued use of the newer dicamba formulations intended to be applied on dicamba-resistant crop varieties. Of particular note is that EPA has not granted a permanent Section 3 registration, instead granting a time-limited, two-year registration which EPA states will expire at the end of 2020. This will allow EPA more time to assess in more detail whether the new use restrictions will further reduce problems of misuse, label complexity, or unexpected drift which have been reported in past growing seasons.
The most vexing issue behind plant injury reports over the past few years is whether these reports are mostly due to misuse (e.g., applicators who do not use the new formulations designed to reduce volatility, which is a label violation since the “old dicamba” product is considered more prone to cause drift injury), or, are due to characteristics of the new formulations which are not yet fully understood and which lead to unexpected volatility and other drift problems. Some have also argued that problems are also due to the difficulty (or reluctance) in following the more prescriptive requirements for the new formulations. The two-year renewal will continue to see EPA closely monitor injury and misuse reports, as well as continued academic and registrant research into the likely cause of any reported problems.
EPA’s decision also imposes further requirements for additional training, timing, record-keeping, and stewardship when using the new dicamba formulations that are designed to reduce or to eliminate those plant injury reports that are not clearly attributable to misuse of the older dicamba products. EPA will rely on state officials to report and evaluate the experience of users in their respective states, especially concerning whether the additional training and stewardship requirements significantly reduce local injury reports.
By James V. Aidala and Margaret R. Graham
On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was accepting public nominations of scientific experts to be considered for ad hoc participation on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) through membership on the Food Quality Protection Act (FQPA) Science Review Board (SRB). 83 Fed. Reg. 49091. EPA states that “all nominees will be considered for ad hoc participation providing independent scientific advice to the EPA on health and safety issues related to pesticides” and requests that any individuals nominated have expertise in one or more of the following areas: biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; aquatic modeling; pharmacology; ecological risk assessment; environmental exposure and fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; statistics; water quality monitoring; hydrologist; Geographic Information Systems (GIS) specialist; computational toxicology; entomology; veterinary entomology; medical entomology, insect ecology, allergenicity, research veterinarian; inhalation toxicology; volatile organics; endocrinology, alternative testing methods, high throughput testing approaches, adverse outcome pathways, cross species extrapolation, and systematic review. The Designated Federal Officer’s to whom nominations should be provided is listed in the Federal Register notice. Nominations are due by November 13, 2018.
FPQA added this SRB to the previous authorization for the SAP to recognize the expanding universe of scientific questions which often underlie issues surrounding pesticide registration. The FQPA amendment simply adds that “60 scientists who shall be available to the SAP” without specifying any particular disciplines or skills which might be useful to assist with the deliberations and review by the SAP. This was intended to continually allow EPA to adapt to changing or evolving scientific questions without constantly tinkering with the membership of the SAP itself. At the same time, it allows these ad hoc members to be recognized for their contributions and to be compensated in the same manner as SAP members.
By Timothy D. Backstrom and Lisa M. Campbell
On September 25, 2018, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit), respondents U.S. Environmental Protection Agency (EPA) and Acting EPA Administrator Andrew Wheeler (collectively EPA) petitioned for an en banc and panel rehearing concerning the Ninth Circuit’s August 9, 2018, decision that granted judicial review of EPA’s initial order denying an administrative petition by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke all tolerances and cancel all registrations for chlorpyrifos, and that specifically directed EPA to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days. More information regarding the August 9 decision is available in our blog item “Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos.”
EPA’s petition for rehearing sets forth three discrete procedural arguments as to why rehearing should be granted. The first argument is that the panel erred because “an initial decision denying an administrative petition under 21 U.S.C. § 346a(d)(4)(A)(iii) is simply not within the jurisdiction of this Court to review ….” EPA contends that the decision to grant judicial review of the initial EPA order, without waiting for EPA to respond to objections or to issue a final order, conflicts with the applicable precedent in both the Ninth Circuit and the U.S. Court of Appeals for the Second Circuit (Second Circuit).
EPA’s second argument is that, even if the initial EPA order is deemed to be reviewable, the panel’s decision directing EPA to take specific actions on remand “exceeded the remedial authority granted the courts by Congress” and conflicts with applicable Supreme Court precedent. EPA identifies some other actions that EPA could hypothetically have decided to take on remand, including denying the administrative petition based on a finding that the Federal Food, Drug, and Cosmetic Act (FFDCA) safety standard is met, reducing the affected tolerances, or revoking only certain tolerances. EPA argues that the court was not empowered to direct EPA to take specific actions, but should have instead remanded the matter to EPA “for further consideration in light of the panel’s holding that EPA may not ‘decline to revoke chlorpyrifos tolerances [without] mak[ing] a finding of reasonable certainty that the tolerances were safe.’”
EPA’s third argument is that, in the event a broader rehearing is not granted, a rehearing by the panel should nonetheless be convened to modify the relief ordered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA argues that revocation of the chlorpyrifos tolerances would not lead automatically to cancellation of all chlorpyrifos registrations, because there are also some non-food uses for chlorpyrifos. EPA states that “FIFRA incorporates the safety standard of the FFDCA only with respect to food-use pesticides …” (emphasis in original). EPA also notes that EPA lacks authority to comply with the court’s order to cancel all chlorpyrifos registrations within 60 days, because EPA must follow the statutory procedure for cancellation under FIFRA Section 6(b), which requires EPA to forward a proposed cancellation first to the U.S. Department of Agriculture (USDA) and the FIFRA Scientific Advisory Panel (SAP), and to afford the affected registrants and other adversely affected persons an opportunity to request an adjudicatory hearing to contest the proposed cancellation. EPA states that the panel should provide at least a limited rehearing, because it granted relief without the benefit of any prior briefing on remedy in which these significant problems would have been identified.
Although parties to appellate litigation often seek rehearing or rehearing en banc, federal agencies represented by the U.S. Department of Justice (DOJ) are considerably more selective about the circumstances in which they will file a petition for rehearing. There are some compelling arguments supported by precedent that judicial review is not available under the FFDCA for the type of initial order concerning which the petitioners in this case sought review. Moreover, EPA has identified some practical factors which make it literally impossible for EPA both to adhere to mandatory statutory procedures under FIFRA and to comply with the terms of the court’s order. For this reason, even if a broader rehearing is not granted concerning the jurisdictional question or the authority of the court to order EPA to take specific actions, a narrower rehearing before the appellate panel may be ordered, which would allow the parties an opportunity for further briefing on remedy and permit the court to modify its order.
More information on chlorpyrifos issues, including further proceedings in this case, is available on our blog under key word chlorpyrifos.
By Timothy D. Backstrom and Lisa M. Campbell
On September 19, 2018, the California Department of Pesticide Regulation (DPR) proposed a regulation to designate chlorpyrifos as a toxic air contaminant (TAC). DPR states that this proposal is being presented “after an extensive period of scientific and public review.” The proposed rule is based on a final evaluation issued in July 2018, in which DPR’s Human Health Assessment (HHA) Branch determined that chlorpyrifos meets the quantitative criteria for designation as a TAC. To make that determination, DPR utilized an inhalation reference concentration (RfC) based on new animal studies with chlorpyrifos that reported neurodevelopmental effects at exposure levels well below the threshold for acetylcholinesterase (AChE) inhibition. More information on DPR’s final TAC evaluation is available in our blog item "California DPR Releases Final Toxic Air Contaminant Evaluation for Chlorpyrifos." In August 2018, DPR posted the Scientific Review Panel on TAC’s findings on chlorpyrifos and the Director’s Proposed Determination Concerning Chlorpyrifos as a TAC.
The U.S. Environmental Protection Agency (EPA) previously issued a determination that the default 10X safety factor for infants and children established by the Food Quality Protection Act (FQPA) should be retained for chlorpyrifos. This determination was based primarily on epidemiology studies that purported to show adverse neurodevelopmental outcomes in humans at exposure levels below the threshold for AChE inhibition, but the methodology used in these epidemiology studies has been harshly criticized by the pesticide industry. In contrast, the DPR TAC proposal is predicated on a determination that new animal studies with chlorpyrifos report neurodevelopmental effects below the threshold for AChE inhibition, and DPR views the epidemiology studies utilized by EPA to make its FQPA determination as providing corroboration for the animal data. At this juncture, it is not clear how EPA will characterize the new animal data concerning chlorpyrifos. In any case, questions are likely to remain concerning EPA’s use of data concerning chorpyrifos to establish the FQPA safety factor for other organophosphate (OP) pesticides.
More information on chlorpyrifos issues and California DPR regulations is available on our blog.
By Margaret R. Graham
On September 20, 2018, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a webinar titled “Best Practices for Ground Application” on October 25, 2018, from 2:00 p.m. to 3:30 p.m. (EDT). The announcement states that this webinar is tailored for “growers, pesticide applicators, pest management professionals, and other interested stakeholders who work in crop production.”
The webinar will be presented by Dr. Greg Kruger, a weed science and application technology specialist from the University of Nebraska-Lincoln and will cover different methods of ground application, best practices for reducing pesticide spray particle drift when using ground application equipment, and a discussion of the optimization of weed control. Registration is available online.
More information on other pesticide applicator issues, including the Worker Protection Standard, is available on our blog.
By Lisa M. Campbell and Timothy D. Backstrom
On August 9, 2018, the majority of a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in the latest chlorpyrifos case (League of United Latin American Citizens (LULAC) v. Wheeler, No. 17-71636) granting the petition for review of a 2017 order by the U.S. Environmental Protection Agency (EPA) that denied an administrative petition to revoke the tolerances for chlorpyrifos; vacating the 2017 order; and remanding the matter back to EPA with explicit directions to EPA to “revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.” A separate dissent stated that the court should have dismissed the case for lack of jurisdiction. Please see our blog item “EPA Denies Petition to Ban Chlorpyrifos” for more information on EPA’s denial of the petition in 2017.
EPA argued in its brief that the court lacks jurisdiction to review the 2017 order denying the petition to revoke the tolerances for chlorpyrifos because Section 408(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to rule on administrative objections to its denial of the petition to revoke the tolerances for chlorpyrifos before judicial review is available under FFDCA Section 408(h)(1).The majority opinion rejected this argument, stating that FFDCA Section 408(h)(1) “does not ‘clearly state’ that obtaining a section (g)(2)(C) order in response to administrative objections is a jurisdictional requirement.” Rather than a jurisdictional limitation, the majority construed the objections process in FFDCA as a non-jurisdictional “claims-processing rule.”In contrast, the dissenting judge agreed with EPA’s argument that the court lacks jurisdiction to review this matter until after EPA responds to the objections to the 2017 order.
After concluding that the objections process is not jurisdictional in character, the majority next considered whether the petitioners should nonetheless be required to exhaust their administrative remedies by waiting until EPA responds to their objections before obtaining judicial review.Although FFDCA Section 408(g)(2)(C) requires EPA to rule on the objections “as soon as practicable,” EPA had taken no action for 13 months after the objections were filed.The majority concluded that the exhaustion requirement should be waived “in light of the strong individual interests against requiring exhaustion and weak institutional interests in favor of it.”
EPA did not specifically address the substantive merits of the 2017 order in its brief, and the majority found that EPA has consequently “forfeited any merits-based argument.”The 2017 order was issued in the context of an administrative record in which EPA has repeatedly determined that the FFDCA standard for maintenance of chlorpyrifos tolerances (“a reasonable certainty that no harm will result from aggregate exposure to the pesticide”) could not be met because of the risk of neurodevelopmental effects. The standard for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) incorporates this same FFDCA standard. Although the 2017 order stated that “the science addressing neurodevelopmental effects is unresolved,” it did nothing to alter these prior EPA determinations. The majority noted that EPA’s assertion that “significant uncertainty” remains regarding the health effects of chlorpyrifos being directly at odds with the “reasonably certainty” standard and “therefore mandates revoking the tolerance under [FFDCA Section 408(b)(2)(A)(i)].” The majority concluded that the possibility that future evidence may contradict EPA’s current determinations cannot justify continued inaction, and that the failure of EPA to proceed with the revocation of the tolerances and the cancellation of the registrations for chlorpyrifos “has now placed the agency in direct contravention of the FFDCA and FIFRA.”
The court’s direct instruction requiring EPA to proceed promptly with revocation of all tolerances and cancellations of all registrations for chlorpyrifos represents an unusually aggressive judicial intervention in the administrative process.Nevertheless, this outcome must be viewed in the context of an eleven year history beginning with an administrative petition that requested the same relief, followed by a writ of mandamus in 2015 from the same court requiring EPA to make a prompt decision on the petition.Although substantial controversy remains concerning the correct interpretation of epidemiology studies with chlorpyrifos, it appears that the court believes that EPA has not taken any action that would support a change in EPA’s prior conclusion that these studies constitute evidence of potential neurodevelopmental effects in children at chlorpyrifos exposure levels below the threshold for acetylcholinesterase (AChE) inhibition. Had EPA’s 2017 denial of the administrative petition been accompanied by an amended risk assessment for chlorpyrifos which articulated a changed conclusion, the court may have been less likely to substitute its judgment for that of EPA.The court seemed to find that because the scientific assessments in the current administrative record could not support the “reasonable certainty” standard in the FFDCA, the conclusion it reached on the merits was unavoidable.
Please see our blog item “Oral Argument Held in Case Challenging EPA’s Denial of Petition to Revoke Chlorpyrifos Tolerances” for information on the oral argument that took place on July 9, 2018, and the briefing in this case. Further information on the case proceedings is available on our blog under key word chlorpyrifos.
By Timothy D. Backstrom
On July 9, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) held oral argument in League of United Latin American Citizens (LULAC) v. Pruitt, a case brought to challenge the decision by the U.S. Environmental Protection Agency (EPA) to deny a 2007 petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC). The 2007 petition requested that EPA revoke all chlorpyrifos tolerances granted under the Federal Food, Drug, and Cosmetic Act (FFDCA) and all chlorpyrifos registrations granted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). After a series of delays and court decisions concerning EPA action on the 2007 petition, the Ninth Circuit issued a writ of mandamus in In re PANNA v. EPA requiring that EPA take action to grant or to deny the petition no later than March 31, 2017. Although EPA proposed in November 2015 to partially grant the 2007 petition and to revoke all chlorpyrifos tolerances based on concerns about neurodevelopmental effects in children, EPA ultimately decided to deny the entire PANNA and NRDC tolerance revocation petition in a decision dated March 29, 2017. More information on EPA’s March 29, 2017, decision is available in our blog item “EPA Denies Petition to Ban Chlorpyrifos.”
After the March 29, 2017 denial decision, the Ninth Circuit denied a motion for further mandamus relief in the PANNA case. The court stated that, once EPA denies a tolerance revocation petition under FFDCA, “[f]iling objections and awaiting their resolution by the EPA Administrator is a prerequisite to obtaining judicial review of EPA’s final response to the petition.” The petitioners in the current LULAC case filed administrative objections to EPA’s denial decision on June 5, 2017, but, on the same date, they also brought a new action seeking immediate judicial review. Five States and the District of Columbia subsequently intervened in the new case. EPA filed a motion to dismiss the LULAC case for lack of jurisdiction on August 21, 2017, but the court denied that motion, without prejudice to EPA renewing its jurisdictional arguments during briefing on the merits.
Background to Tolerance Petition Decision
EPA’s risk assessments concerning the potential neurodevelopmental effects of chlorpyrifos have been the subject of scientific controversy for a number of years. In decisions that were the subject of significant criticism and controversy, EPA scientists construed the associations reported in certain epidemiological studies of exposure to chlorpyrifos as evidence that chlorpyrifos may cause neurodevelopmental effects in children at exposure levels that are less than the threshold for induction of acetylcholinesterase inhibition. In November, 2016, EPA issued an updated risk assessment for chlorpyrifos and all organophosphate (OP) pesticides based on the same epidemiology studies, which included a determination that EPA would retain the default 10X safety factor established by the Food Quality Protection Act (FQPA) for chlorpyrifos and for all OP pesticides. Pesticide industry representatives have raised concerns about the design and conduct of the chlorpyrifos epidemiology studies, the scientific plausibility of the proposed association of neurodevelopmental effects with low level chlorpyrifos exposure, and the rationale for extending the FQPA determination to OP pesticides other than chlorpyrifos.
Prior to the change in administration in 2017, it appeared that EPA would proceed with its 2015 proposal to revoke chlorpyrifos tolerances based on the 2016 updated risk assessment. Instead, on March 29, 2017, EPA decided to deny the 2007 petition and to defer its ultimate scientific decision concerning the neurodevelopmental effects of chlorpyrifos until after EPA completes the currently pending registration review process for chlorpyrifos.
Briefs in the LULAC Case
In their briefs, the petitioners and the intervenors in the LULAC case have objected to further delay in EPA’s scientific decision concerning the neurodevelopmental risks presented by chlorpyrifos, as well as to the procedures specified by FFDCA that would require that they await resolution of their objections before seeking judicial review. From their perspective, EPA has already determined repeatedly that continued chlorpyrifos exposure is unsafe for infants and children, and EPA is therefore required to proceed with immediate revocation of all chlorpyrifos tolerances.
In their briefs, the petitioners and the intervenors argued that the procedures required by FFDCA are not jurisdictional, and that the court therefore has discretion to waive exhaustion of these procedures. They also argued that exhaustion should be waived in this instance because allowing EPA time to rule on their objections would ultimately be futile, and because further delay would perpetuate EPA’s purported disregard of the FFDCA safety standard. Further, they argued that, if immediate review is not available under FFDCA, it should be available under FIFRA because EPA also denied a request to cancel the FIFRA registrations for chlorpyrifos. Finally, the petitioners requested during briefing that the court issue “a writ of mandamus directing EPA to decide LULAC’s objections within 60 days.”
In its brief, EPA argued that the petitioners lack any jurisdiction to bring the current case because the detailed procedures specified in the FFDCA are jurisdictional in nature, and exhaustion of these procedures therefore cannot be waived by a reviewing court. EPA also argued that, even if the court could waive the exhaustion requirement, the petitioners have raised the same issues in their objections as they raised in their briefs, and there is no basis for the court to presume that allowing EPA to address these issues would be futile. Moreover, EPA argued that FFDCA Section 346a(h)(5) expressly precludes separate judicial review under FIFRA of EPA’s decision concerning the 2007 petition. Finally, EPA contended in its brief that the petitioners’ request for a writ of mandamus must be denied because the petitioners did not follow the procedure for making such a request in Federal Rule of Appellate Procedure 21(a).
During the oral arguments on July 9, 2018, two of the three judges on the Ninth Circuit panel reportedly expressed frustration concerning the prospect for years of further delay before EPA makes its ultimate decision concerning chlorpyrifos. Although it is not clear how the court would overcome the formidable jurisdictional barriers to immediate judicial review, it appears that some sort of judicial decision or order compelling EPA to take more immediate action on chlorpyrifos is a possibility. More information regarding these proceedings is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and Lisa R. Burchi
On April 30, 2018, the U.S. District Court for D.C. issued a memorandum opinion that sets forth the reasons for its denial of defendant Monsanto Company’s (Monsanto) motion to dismiss in a case in which the plaintiffs allege that certain glyphosate label claims violate the District of Columbia Consumer Protection Procedures Act (DCCPPA) (Opinion). The order denying Monsanto’s motion to dismiss was issued on March 31, 2018, but did not provide any substantive discussion as to why it was denied, only that a statement that the reasons would be provided in 30 days.
Plaintiffs Beyond Pesticides, et al.’s amended complaint alleges that under the DCCPPA “the claim that Roundup targets an enzyme ‘found in plants but not in people or pets’ is false and misleading because that enzyme ‘is found in people and pets’” (emphasis in original), because, plaintiffs assert, “glyphosate, the active ingredient in Roundup, targets an enzyme that exists in ‘gut bacteria’ found in humans and other mammals.” The amended complaint additionally alleges that Monsanto “is aware that its labels and advertising are false … but continues to repeat this claim because ‘consumers are more likely to buy -- and will pay more for -- weed killer formulations that do not affect people and animals.’”
Monsanto’s motion to dismiss, filed on July 10, 2017, stated that plaintiffs’ “claims are time-barred, that Plaintiffs fail to state a claim because the statement at issue is not false or misleading, and that Plaintiffs’ claims are preempted by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].”
The Opinion outlines the reasons for the court’s conclusion that the claims are not time-barred, at least for purposes of deciding the motion to dismiss. The Opinion states, in response to some of the arguments that the claims were time-barred, that the court has “little trouble concluding that Plaintiffs’ claims are not time-barred in their entirety,” and that Monsanto is “entitled to renew its argument that some portion of Plaintiff’s claims are time-barred at the summary judgment stage.”
With regard to the court’s decision that plaintiffs “have adequately pleaded a claim” that Roundup’s label is false or misleading under the DCCPPA, the Opinion states: “Roundup supposedly targets an enzyme that is not found in people or animals, but that enzyme is, in fact, found in their gut bacteria.” Moreover, the Court notes that “even if the statement on Roundup’s label is not ‘literally false,’ Plaintiffs have also alleged that it is also misleading.” For these reasons, the Opinion states, the Court “cannot conclude that ‘no reasonable person would be deceived’ by the Roundup label, such that dismissal of Plaintiffs’ claims would be appropriate.”
Perhaps of most interest is the Opinion’s discussion of the preemption claim in light of the fact that the claims at issue are claims approved on multiple occasions by the U.S. Environmental Protection Agency (EPA) as part of its approval of the label. The Opinion states that “Plaintiffs’ claims are not preempted because the DCCPPA, as it relates to pesticide labels, does not impose a broader or different obligation than FIFRA.” Rather, “[u]nder both statutes, false or misleading statements on a pesticide label are proscribed.” The Opinion cites the Supreme Court case Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) in stating that “the question is not whether the statute reaches conduct beyond such labeling,” but “whether the statute ‘impose[s] a labeling requirement that diverges from those set out in FIFRA and its implementing regulations’” (emphasis in original). Moreover, the Opinion finds that a request for declaratory relief is not “functionally a requirement that the company change its label.” Instead, the Opinion distinguishes between the declaration that plaintiffs seek, that Monsanto’s label violates the DCCPPA, and an injunction stating that the declaratory relief requested “would not require Monsanto to change its label, even though it might well ‘induce’ it to do so” (emphasis in original). The Court found that for this reason the requested relief is not preempted by FIFRA.
Registrants should pay attention to the potential implications of this case, and others like it, particularly with regard to label claims that EPA has approved. More information on other glyphosate issues is available on our blog.
By Heather F. Collins, M.S.
On April 24, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has updated Chapters 3, 7, and 17 of the Pesticide Label Review Manual. The three updated Label Review Manual chapters are:
- Chapter 3: General Labeling Requirements;
- Chapter 7: Precautionary Statements; and
- Chapter 17: Net Contents/Net Weight.
General Labeling Requirements (Chapter 3) changes include:
- Updating web-distributed labeling by adding an example of container label directions;
- Updating label submission requirements section to include e-submission methods depending on the type of application package (e.g., paper or electronic);
- Adding a note that five copies of all draft labeling must be included in paper copy submissions for new registrations and amendments;
- Updating the final printed labeling section to reflect current practices such as the practice of not requiring final printed labeling to be submitted to EPA until draft label texts have been provisionally accepted by the EPA;
- Updating the Mode of Action (MOA) classification symbol reference from Pesticide Registration (PR) Notice 2001-5 to the current PR Notice 2017-1; and
- Updating the first aid statement location per EPA’s February 27, 2018, guidance document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.”
Precautionary Statements (Chapter 7) changes include:
- Adding dermal sensitization to the acute toxicity categories in Table 1;
- Reinstating first aid statements per PR Notice 2001-1, and updating location of first aid statements per the Feb. 27, 2018, First Aid Guidance Document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68”;
- Adding “Contains the phosphine-producing active ingredient zinc phosphide. Probable mucosal damage may contraindicate the use of gastric lavage” as a Note to Physician for products containing zinc phosphide;
- Updating the National Pesticide Information Center (NPIC) information in the first aid statements example in Table 9;
- Changing “Labeling Options” section title to “Modified precautionary statements for diluted products (aqueous solutions only)”;
- Removing redundant section on NPIC and referenced Chapter 15 for details; and
- Removing “Optional Labeling/Deviations” section, as the directions moved to their respective sections.
Net Contents/Net Weight (Chapter 17) changes include:
- Updating the introduction section to include notes on declaring net contents information on the EPA Application for PR Dorm (EPA Form No. 8570-1) and leaving net contents information blank on draft label for refillable containers; and
- Updating the U.S. Department of Commerce’s National Institute of Standards and Technology’s (NIST) published “Uniform Laws and Regulations in the Areas of Legal Metrology and Engine Fuel Quality,” otherwise known as “NIST Handbook 130,” reference for Bag on Valve unit measurements.
Each updated chapter includes a new section identifying the changes in the updated version. EPA states that it “also made editorial changes to all chapters, including updated cover pages; adding a table of contents; adding chapter editorial notes; updating hyperlinks; and reformatting text, style and layout for conciseness and readability.”
EPA directs registrants to submit questions or comments on the Label Review Manual by using its Pesticide Labeling Questions & Answers – Form.