By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced it is implementing a new policy regarding the evaluation and registration of new conventional pesticide active ingredients (AI) to comply further with the Endangered Species Act (ESA) (ESA Policy). EPA also issued a Question and Answer document regarding its ESA Policy. Effective immediately, EPA will evaluate the potential effects of new conventional AIs on federally threatened or listed endangered species (Listed Species) and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary before EPA registers any new conventional AIs. The new ESA Policy will apply to all new conventional AI applications, including applications already submitted to EPA but not yet completed.
Under the ESA, EPA must ensure that its actions are not likely to result in jeopardy or adverse modification of designated critical habitat or Listed Species. To determine whether the action may affect Listed Species and their designated critical habitats, EPA makes one of three types of species-specific effects determinations: No Effect (NE), Not Likely to Adversely Affect (NLAA), or Likely to Adversely Affect (LAA). EPA states that historically it did not “consistently assess the potential effects of conventional pesticides on listed species when registering new AIs.” This, EPA states, “resulted in insufficient protections from new AIs for listed species, as well as resource-intensive litigation against EPA for registering new AIs prior to assessing potential effects on listed species.” EPA believes its new ESA Policy should assist in reducing these types of cases against EPA and improve the legal defensibility of new AIs.
EPA states that under the new ESA Policy, if EPA makes an LAA determination through its analyses of a new conventional pesticide AI, EPA will initiate formal consultation with the Services before granting a new AI registration. As part of its analysis and under its existing authorities, EPA will consider the likelihood that the registration action may jeopardize the continued existence of Listed Species or adversely modify their designated critical habitat and provide its findings to the Services. To determine or predict the potential effects of a pesticide on these species and habitats, EPA will use appropriate ecological assessment principles and apply what it has learned from past effects determinations and the Services’ biological opinions. EPA states it is determining whether any new information would be useful for assessing the potential impacts on Listed Species from a new AI, and it will specifically contact registrants that have a new Al application currently under consideration to discuss whether additional information is necessary for EPA’s ESA assessment for the new conventional AI.
If EPA determines that jeopardy or adverse modification is likely for a designated critical habitat or Listed Species, it will only make a registration decision on the new conventional AI after requiring registrants to implement mitigation measures that EPA determines would likely prevent such jeopardy or adverse modification. If EPA finds that a new AI is likely to affect adversely a Listed Species or its critical habitat, but that a jeopardy or adverse modification is not likely, it may nonetheless require registrants to include mitigation measures as part of their registration and product labeling to minimize the potential effects of incidental take to Listed Species that could result from use of a pesticide. In both situations, formal consultation with the Services would still be necessary, as EPA states final jeopardy or adverse modification determinations must be made by the Services. Regarding timeframes, EPA states in the Q&A that it “strives to complete new AI applications within PRIA timelines,” but will work with affected registrations to “renegotiate” PRIA deadlines if EPA believes additional time will be needed under the ESA Policy.
EPA states that it has prioritized conventional pesticide AIs but that it is continuing to explore applying these new ESA approaches to new biopesticide AIs and new antimicrobial AIs. EPA also is developing a comprehensive strategy to address ESA for pesticides at all stages of the registration process. EPA is currently developing a detailed work plan to outline additional improvements to further its compliance with the ESA, including steps to implement protections for high-risk species more efficiently, provide growers with more flexible mitigation measures, and increase stakeholder engagement.
This announcement represents the next attempt by the Office of Pesticide Programs (OPP) to comply with ESA requirements in a way that, as the ESA Policy points out, will be more legally defensible while continuing its work to review and approve new pesticide AIs. In recent years, EPA has tried various arguments, mostly futile, to convince courts that past attempts to comply with ESA were sufficient.
This ESA Policy hints at important changes both in EPA’s past rhetoric regarding compliance and possible changes to the ways ESA assessments have been conducted in the past. On the record, EPA has maintained it complied with ESA when registering a new product. The courts have found this claim unsupported and almost always agreed with groups that challenged that claim. There have been a few exceptions where EPA, while not entirely resolving ESA concerns, had more “up front” consideration of ESA issues. Such earlier attention to resolving any ESA concerns, however, can add significantly to the time spent and data requirements to evaluate and address ESA issues.
Any relatively successful cases over past years complement the renewed and explicit commitment by the Biden Administration with the ESA Policy to attempt to resolve the long-standing problem of establishing a registration process that better addresses ESA issues with, among other things, improved coordination between EPA procedures and the review process (and conclusions) of the Services. Past Administrations have expressed similar rhetoric, but so far, many have tried, and all have failed.
In various forums, EPA has dryly described the efforts generally as -- “EPA is currently developing a detailed work plan to outline additional improvements to further the Agency’s compliance with the ESA.” More importantly, perhaps, and new to the mix is that EPA now has a senior political appointee (Jake Li as Deputy Assistant Administrator of OCSPP) especially tasked to lead efforts regarding the ESA-FIFRA integration process.
For applicants and registrants of new conventional AIs, these revised efforts may lead to some delays in the current expected timeframes to “work out” ESA concerns earlier in the process. And importantly, EPA’s ESA Policy describes how new approvals will include more “up front” mitigation measures designed to protect threatened and endangered species to a sufficient, or at least better, degree -- which appears to be a key change designed to reduce the litigation risks that have dogged new registration decisions in recent years.
By James V. Aidala and Lisa R. Burchi
On November 18, 2021, the United Farm Workers and several other non-governmental organizations (NGO) filed a petition with the U.S. Environmental Protection Agency (EPA) to revoke all food tolerances and cancel registrations for organophosphate (OP) pesticides (Petition). The Petition was filed pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 346a(d), the Administrative Procedure Act (APA), 5 U.S.C. Section 551, and the First Amendment Constitutional Right to Petition.
The Petition seeks final EPA actions to revoke tolerances and cancel registrations for 15 OPs by the registration review deadline of October 1, 2022.
The Petition also states that EPA must take the following actions:
- Update EPA’s human health risk assessments (HHRA) for OP pesticides to use a regulatory endpoint that the Petition claims will protect children from learning disabilities and other neurodevelopmental harm.
- Complete Endangered Species Act (ESA) consultations and ensure its registrations comply with the ESA;
- Conduct endocrine disruptor screening of all pesticides.
- Complete a cumulative risk assessment for all the OPs to address their cumulative acute poisoning and neurodevelopmental effects.
The Petition focuses on 15 OPs that are currently going through registration review:
- Acephate (EPA-HQ-OPP-2008-0915);
- Bensulide (EPA-HQ-OPP-2008-0022);
- Chlorethoxyfos (EPA-HQ-OPP-2008-0843);
- Chlorpyrifos-methyl (EPA-HQ-OPP-2010-0119);
- Diazinon (EPA-HQ-OPP-2008-0351);
- Dichlorvos (EPA-HQ-OPP-2009-0209);
- Dicrotophos (EPA-HQ-OPP-2008-0440);
- Dimethoate (EPA-HQ-OPP-2009-0059);
- Ethoprop (EPA-HQ-OPP-2008-0560);
- Malathion (EPA-HQ-OPP-2009-0317);
- Naled (EPA-HQ-OPP-2009-0053);
- Phorate (EPA-HQ-OPP-2007-0674);
- Phosmet (EPA-HQ-OPP-2009-0316);
- Terbufos (EPA-HQ-OPP-2008-0119); and
- Tribufos (EPA-HQ-OPP-2008-0883).
Now that EPA is in receipt of the Petition, it must determine that it has received a “complete” petition to revoke a tolerance based on criteria set forth in EPA’s regulations (40. C.F.R. § 180.7). If EPA determines the Petition is complete, it will publish in the Federal Register within 30 days a notice of filing for the Petition, which must include the informative summary of the Petition submitted by the petitioner. FFDCA Section 408(d)(3). A public comment period follows.
Generally, the Petition is an important signaling document that the petitioners use to outline how EPA should approach the 2022 registration review deadline for these OP products. It signals that unless EPA completes all elements of a registration review, including a complete ESA assessment and an endocrine disruptor review -- which may be impossible for EPA to complete -- then EPA should act now to revoke OP tolerances in light of arguments contained in the Petition. It stresses the environmental justice commitments announced by the Biden Administration, arguing that evidence is clear, in their view, of the need to take immediate action to end OP use across virtually all of the members of the class. It seems to anticipate that even if EPA rolls out registration reviews of the individual OP pesticides before the deadline, there will likely be comment and debate about the specific analyses and evaluation of each member of the category. This would additionally delay the completion of any revised cumulative risk assessment for the OPs.
From the view of the petitioners, not only will EPA miss the 2022 deadline, but they also argue the evidence is sufficient now for EPA to take action to revoke tolerances for these compounds based on evidence already before EPA. Other stakeholders and EPA’s eventual analyses will dispute such conclusions, but completing registration review (as defined in the Petition) will likely be impossible to complete before next October. As a result, the Petition here suggests the template these advocacy groups will use to challenge continued registration of OP products past the 2022 deadline.
By Timothy D. Backstrom and Kelly N. Garson
On December 6, 2019, the European Union (EU) announced that it will no longer permit sales of chlorpyrifos after January 31, 2020. The Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) voted in favor of two draft Implementing Regulations that denied the renewal of approvals for chlorpyrifos and chlorpyrifos-methyl. The European Commission is expected to formally adopt the regulations in January 2020. At that time, Member States will need to withdraw authorizations for products containing chlorpyrifos and chlorpyrifos-methyl as active substances and may implement a grace period, at a maximum of three months, for final storage, disposal, and use of the substances.
The ban in the EU follows increased concerns over the human health effects of the substances. On August 2, 2019, the European Food Safety Authority (EFSA) published a report concluding that no safe exposure level could be determined for chlorpyrifos and that based upon available data, the approval criteria under Article 4 of Regulation (EC) No 1107/2009 for human health were not met. EFSA also published an updated statement reiterating the same conclusion for chlorpyrifos-methyl on November 26, 2019. EFSA’s primary health concerns were potential developmental neurotoxicity based on the available animal data and epidemiological evidence, and unresolved concerns regarding potential genotoxicity. EFSA also concluded that toxicological reference values could not be established for either of these effects, thereby precluding a valid risk assessment for consumers, workers, or bystanders.
Prior to the PAFF Committee meeting, eight EU states had already banned or never approved the use of chlorpyrifos. Canada proposed a ban of chlorpyrifos on May 31, 2019. (More information on this proposal is available in our blog post).
Within the United States, state governments have taken steps to regulate chlorpyrifos. On June 13, 2018, Hawaii passed an act that banned the use of pesticides containing chlorpyrifos as an active ingredient beginning January 1, 2019.
Several recent actions in California culminated in a ban on chlorpyrifos. First, the California Department of Pesticide Regulation (DPR) decided that chlorpyrifos should be designated as a Toxic Air Contaminant. This action was based primarily on a point of departure derived from new animal studies that report neurodevelopmental effects well below the level that inhibits cholinesterase. On August 14, 2019, DPR issued cancellation notices for chlorpyrifos products based primarily on the same new animal data. DPR subsequently announced on October 9, 2019, an agreement with pesticide manufacturers to end the sale of chlorpyrifos by February 6, 2020. Growers will not be able to possess or use chlorpyrifos products in the state after December 31, 2020.
In New York State (NYS), recent efforts to ban the substance through legislation were unsuccessful. On December 10, 2019, NYS Governor Andrew Cuomo vetoed a bill passed by the NYS Legislature (A.2477/S.5343) to phase out chlorpyrifos from use by December 1, 2021. Governor Cuomo stated that the NYS Department of Environmental Conservation is responsible for taking regulatory action on the issue, but recommended that the agency implement its own phased-in ban of chlorpyrifos.
On the federal level, chlorpyrifos products remain registered and have been since 1965. The U.S. Environmental Protection Agency (EPA) has taken measures to restrict the use of chlorpyrifos within households and on particular crops, but some non-governmental organizations (NGO) have long advocated that chlorpyrifos should be banned in its entirety. On September 12, 2007, the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) filed a petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos. EPA’s failure to respond fully to this petition was the subject of several decisions in the 9th Circuit Court of Appeals, and the Court ultimately issued a writ of mandamus requiring that EPA take final action concerning the petition.
At one point, EPA proposed to revoke all tolerances for chlorpyrifos. This action was based in part on a controversial determination that EPA should reinstate the default safety factor for tolerance assessments under the Food Quality Protection Act (FQPA) for all organophosphate (OP) pesticides. This determination was based on developmental neurotoxicity associated with chlorpyrifos exposure in certain epidemiology studies. After further deliberation and a change of administrations, EPA issued an order denying the 2007 petition in its entirety on March 29, 2017, based in part on a conclusion stating that further evaluation was needed to properly assess potential neurodevelopmental effects of chlorpyrifos. EPA later issued a final order that denied all objections to the March 2017 petition denial order. A number of NGOs (including the original petitioners) and several states have challenged this decision, filing petitions on August 8 and August 9, 2019, respectively for judicial review of EPA’s final order retaining tolerances and registrations for chlorpyrifos. EPA has stated that it intends to complete its evaluation of the epidemiology studies for chlorpyrifos, as well as the new animal data relied on by California, in the context of the pending registration review of chlorpyrifos under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(g). A final registration review decision concerning chlorpyrifos is due by October 1, 2022, although EPA has stated that it intends to accelerate that process. More information on the petitions and chlorpyrifos is available on our blog.
At this juncture, the long-term impact of the gradual accumulation of adverse decisions on chlorpyrifos from EFSA and various other governmental agencies is uncertain. Most user groups in the United States continue to describe chlorpyrifos as an essential agricultural tool. Some commodities treated with chlorpyrifos are destined for export markets where chlorpyrifos has been banned, however, and the impacts of this change will need to be monitored closely.
EPA’s interpretation of the epidemiology studies for chlorpyrifos remains controversial in the scientific community. Indeed, although the EFSA conclusion is predicated in part on these epidemiology studies that are the basis of the controversial EPA interpretation, the wording of the EFSA report indicates that there were some dissenters. Moreover, the extension of EPA’s FQPA determination for chlorpyrifos to other organophosphate (OP) pesticides has never been satisfactorily explained.
The NGOs and states that have challenged EPA’s final order refusing to revoke the tolerances and cancel the registrations for chlorpyrifos will argue that the final order cannot be reconciled with EPA’s prior scientific determinations. Even if EPA can successfully rebut those arguments, there is also a possibility that EPA’s own review of the new animal chlorpyrifos studies may obviate that controversy. On balance, the remaining manufacturers and registrations for chlorpyrifos are likely to confront a variety of challenges in the coming months.
By Timothy D. Backstrom and James V. Aidala
On December 18, 2019, the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) issued for comment a Proposed Interim Decision (PID) in the ongoing registration review process for each of the three registered triazine herbicides: atrazine, propazine, and simazine. EPA will allow 60 days for comment on each of these triazine PIDs, but the specific comment deadline will only be established after EPA has published notice concerning the proposed interim decisions in the Federal Register. EPA can utilize an “interim registration review decision” under 40 C.F.R. Section 155.56 whenever it is not yet ready to complete the registration review process, but EPA has nonetheless completed sufficient review to determine that new or interim risk mitigation measures are needed or that additional data or information should be submitted to complete the review. For each of the three triazine herbicides, EPA is proposing to impose specific risk mitigation measures for particular registered uses to mitigate potential health and environmental risks. For each triazine herbicide, EPA is not yet ready to make a final registration review decision because EPA has not made findings in the Endocrine Disruptor Screening Program (EDSP) or an effects determination under the Endangered Species Act (ESA). Several key factors that will affect the final registration review decision for each of the triazine herbicides are discussed below.
Common Factors for Triazine Risk Assessment
There are several common factors to consider with regard to the triazines risk assessment. These include:
- Atrazine, propazine, and simazine are all included in the chlorotriazine chemical class. EPA has determined that these three herbicides, along with three specific chlorinated metabolites, share a common mechanism of toxicity, so human health risks from all of these substances are being assessed by EPA together through one cumulative triazine risk assessment. The contribution of each product to aggregate human risk differs because of somewhat dissimilar use patterns. The combining of risks resulting from use of each triazine means, however, that it may be necessary for EPA to coordinate the ultimate registration review decisions for the three active ingredients.
- As part of the ecological risk assessment for each triazine herbicide, EPA plans to make an effects determination for potentially vulnerable species under the ESA, which in turn will determine whether it is necessary for EPA to consult with the Fish and Wildlife Service or the National Marine Fisheries Service (the Services) concerning potential impacts of each active ingredient and relevant metabolites on endangered or threatened species. Atrazine, propazine, and simazine are all included in a stipulated settlement between the parties in Center for Biological Diversity et al. v. EPA et al. No. 3:11 cv 0293 (N.D. Cal.), and EPA agreed in that stipulated settlement to set August 14, 2021, as the deadline for EPA to make a nationwide effects determination for each active ingredient, and to request any required consultation with the Services, under ESA Section 7(a)(2).
- EPA states that the predominant human health effect of concern for all three of the triazine herbicides and their chlorinated metabolites is potential suppression of the luteinizing hormone (LH) surge, which is considered to be both a neuroendocrine and a developmental effect. Atrazine and simazine were both included on List 1 for screening testing under the EDSP required by the Food Quality Protection Act (FQPA) amendments. All of the required Tier 1 screening assays for each of these substances are complete and have been evaluated by EPA, but EPA has not yet made human health or environmental findings under the EDSP. The EDSP screening testing has not been completed yet for propazine.
Risk Mitigation Measures
Each PID proposes specific risk mitigation measures intended to address potential human and environmental risks identified by the EPA risk assessments.
For atrazine, the PID includes the following measures to mitigate aggregate human risk:
- Reduce the permissible application rates for use of granular and liquid formulations on residential turf.
- Require additional personal protective equipment (PPE) and engineering controls for certain uses.
- Restrict aerial applications to liquid formulations only.
- Limit backpack sprayer applications to landscape turf to spot treatment only.
- Prohibit pressurized handgun application to certain commodities.
To mitigate ecological risks, the atrazine PID proposes to require various spray drift reduction measures, to add a non-target advisory statement to labeling, and to adopt a nationwide stewardship program.
For propazine, the PID proposes to cancel the greenhouse use to mitigate aggregate human risk. Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.
For simazine, the PID includes the following measures to mitigate aggregate human risk:
- Cancel simazine use on residential turf.
- Require additional PPE and engineering controls for certain uses.
- Limit pressurized handgun applications to certain commodities to spot treatment only.
Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.
In each of the PIDs for the triazine herbicides, EPA has focused its efforts on adopting mitigation measures which should be efficacious in reducing human and ecological risks without materially impairing the availability of the products in question for key agricultural uses. In some instances, the PID documents explicitly state that the product registrants have agreed to proposed changes. An EPA Pesticide Program Update dated December 19, 2019, that discusses the interim decision for atrazine includes statements of support from several grower groups.
By Timothy D. Backstrom
On December 5, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced the availability of a revised interim registration review decision for use of sodium cyanide in the M-44 predator control device. The M-44 device is a restricted use pesticide (RUP) and may be used only by certified applicators in compliance with specific mandatory restrictions set forth on the label. Although the registration review process for sodium cyanide remains pending, EPA has decided to issue an interim decision for the M-44 device now to adopt new label restrictions intended to mitigate potential risks. The revised interim decision adopts two new restrictions and also modifies certain existing restrictions, which EPA states "will reduce the potential for unintended impacts on humans, pets, and other non-target animals.”
The M-44 predator control device uses a spring-loaded ejector to fire a capsule containing a single lethal capsule of sodium cyanide. The M-44 is used by livestock producers to control predators (primarily coyotes) that kill sheep, goats, and cattle. Registrations for the M-44 device are currently held by the U.S. Department of Agriculture, and by five individual States (South Dakota, Texas, Montana, Wyoming, and New Mexico) where livestock predation has been a particular problem.
New or revised restrictions that will be incorporated in the approved labeling for the M-44 device include:
- Requiring a 600-foot buffer zone around residences where an M-44 cannot be used (except for a cooperating landowner who has given written permission).
- Requiring that the applicator notify occupants of all residences within a 0.5 mile radius (by face-to-face communication, person-to-person telephone communication, door hanger, or certified mail) prior to an M-44 placement.
- Increasing from 50 feet to 300 feet the distance from designated public paths and roads where M-44 use is prohibited.
- Requiring two elevated warning signs placed 15 feet from the M-44 device and facing the most likely directions of approach, instead of one elevated sign placed 25 feet from the device.
Livestock producers and State departments of agriculture contend that the M-44 device is essential to limit economic losses resulting from predation, which reportedly amount to hundreds of millions of dollars annually. In contrast, wildlife advocates have strongly opposed any continued use of the M-44 device. In 2017, WildEarth Guardians and the Center for Biological Diversity petitioned EPA to suspend and cancel all registrations for M-44 capsules, but EPA concluded that the petition did not contain substantial new information and denied the petition in 2018. Although the new and modified label restrictions adopted by EPA in the interim decision for the M-44 device are not likely to satisfy opponents, these changes should nonetheless reduce the likelihood that humans, pets, or other non-target species will be exposed to the M-44 capsules or the toxin they contain.
By Lisa M. Campbell, Timothy D. Backstrom, Lisa R. Burchi, and James V. Aidala
On July 12, 2019, the U.S. Environmental Protection Agency (EPA) announced in a Decision Memorandum that it has registered new uses and restored previously registered uses for sulfoxaflor. EPA has approved the use of sulfoxaflor on alfalfa, corn, cacao, grains (millet, oats), pineapple, sorghum, teff, teosinte, tree plantations, and restored the uses on citrus cotton, cucurbits (squash, cucumbers, watermelons, some gourds), soybeans, and strawberries. EPA states that substantial data show that when sulfoxaflor is used according to the label, it poses no significant risk to human health and poses a lower risk to non-target wildlife, including pollinators, than other registered alternative products. EPA’s registration decision is available at www.regulations.gov in Docket Number EPA-HQ-OPP-2010-0889-0570.
EPA’s decision follows an opinion issued on September 10, 2015, by the U.S. Court of Appeals for the Ninth Circuit vacating EPA’s 2013 unconditional registration for the pesticide sulfoxaflor, and remanding the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies. That decision is discussed in our blog item available here. In response to that decision, EPA also issued a cancellation order that included provisions for the disposition of existing stocks of sulfoxaflor products.
After the decision of the Ninth Circuit Court of Appeals, EPA reevaluated the data and on October 14, 2016, approved sulfoxaflor end-use registrations for limited uses that did not include crops that attract bees. EPA also has been granting emergency exemptions for sulfoxaflor since 2012, with the most recent emergency exemptions granted on June 17, 2019, for the use of sulfoxaflor to control tarnished plant bugs on cotton in 12 states, and to control sugarcane aphids on sorghum in 14 states.
In the July 12, 2019, decision adding new uses, restoring previous uses, and removing certain application restrictions, EPA states an unconditional registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(5) for new uses of sulfoxaflor is backed by substantial data, including numerous pollinator studies submitted by the registrant, Dow AgroSciences (DAS). With specific regard to sulfoxaflor’s impact on bees, EPA states the following:
Since the vacatur in 2015, DAS has submitted numerous additional pollinator studies. The pollinator data requirements listed in 40 CFR 158.630 have all been submitted or waived. EPA’s risk assessment process for pollinators has evolved since those data requirements were promulgated and now EPA generally assesses risks to bees using a three-tier process based on a more robust data set as described in two guidance documents: “Guidance for Assessing the Risks of Pesticides to Bees” (USEPA 2014) and “Guidance on Exposure and Effects Testing for Assessing Risks to Bees” (USEPA 2016). For sulfoxaflor, all Tier I data have been submitted. Three additional Tier II semi-field (tunnel) studies and two colony feeding studies have been submitted. Pollen and nectar residue data have been submitted for multiple crops. The submitted data covers all of the requested use patterns. For those crops that did not have data specific to pollen and nectar residues, data was extrapolated as appropriate from other crops. All regulatory data requirements for assessing pollinators have now been addressed and the EPA has adequate data to demonstrate that there will be no unreasonable adverse effects to honey bees resulting from the expanded registration of sulfoxaflor.
EPA’s decision also removes previously imposed application restrictions:
- Removed the prohibition of use on crops grown for seed because EPA believes pollinator protection restrictions, including low use rates, will be in place regardless of whether the crop is grown for seed or for commodity harvest;
- Removed the restriction to post-bloom application for bee-attractive crops only when there is low risk or limited potential for exposure to bees;
- Removed the 12-foot buffer requirement because EPA believes the spray drift mitigation requirements on labels are adequate to limit drift; and
- Removed the 2016 restriction against tank mixing because EPA states data show that there is no additional risk when sulfoxaflor is tank mixed with other compounds.
EPA’s decision includes the following crop specific restrictions:
- Citrus: Only one application is allowed per year between 3 days before bloom and until after petal fall.
- Ornamentals: Only one application is allowed during bloom, and that bloom must not exceed a rate of 0.071 lb ai/acre.
- Pome Fruit, Stone Fruit, Tree Nuts and Pistachio: No application is allowed any time between 3 days prior to bloom and until after petal fall.
- Small Fruit Vine Climbing and Low Growing Berry, Tree Plantations: No application is allowed any time between 3 days prior to bloom and until after petal fall.
EPA found that the FIFRA standard for registration is met for the registration of sulfoxaflor on the uses approved, and that the benefits of these uses outweigh the risks, but also set specific label requirements including restrictions to minimize potential exposure to bees:
- Worker Protection: “Applicators and other handlers must wear: Long-sleeved shirt and long pants, shoes plus socks, protective eyewear” and “Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of” 24 hours (for Transform WG label) and 12 hours (for Closer SC label).
- Environmental Hazards Statement: “This product is highly toxic to bees and other pollinating insects exposed to direct treatment or to residues in/on blooming crops or weeds. Protect pollinating insects by following label directions intended to minimize drift and reduce pesticide risk to these organisms.”
- The RT25 (how long foliar residues of sulfoxaflor exhibit toxicity to honey bees): “The RT25 for this product is less than or equal to 3 hours.”
- Directions for Use: “Notifying known beekeepers within 1 mile of the treatment area 48 hours before the product is applied will allow them to take additional steps to protect their bees. Also, limiting application to times when managed bees and native pollinators are least active, e.g. 2 hours prior to sunset or when the temperature is below 50°F at the site of application will minimize risk to bees.”
This new decision by EPA may finally be the culmination of a long and convoluted process to register sulfoxaflor. The litigation that resulted in vacatur of the initial registrations began in 2013. At the time the Ninth Circuit issued its decision in 2015, vacatur was viewed by many observers as a novel and radical response to an EPA decision to register a new pesticide. Since that time, registrants and users of newly approved active ingredients have encountered more aggressive litigation in which vacatur is often cited as a possible remedy. This has created more uncertainty and concern about product availability, even after EPA approves an eagerly anticipated new product to meet a pressing pest control need. In the case of sulfoxaflor, EPA has clearly determined that the data submitted by DAS demonstrate that any risks to pollinators presented by sulfoxaflor will be less than the risks presented by currently registered insecticides sulfoxaflor is likely to replace. This determination concerning relative risk based on review of additional data should address the deficiencies in the EPA rationale found by the Court when it vacated the 2013 sulfoxaflor registrations.
Interestingly, the current EPA decision may raise a similar issue concerning the sufficiency of EPA’s rationale concerning the effects of sulfoxaflor on endangered species. EPA states the following in its Decision Memorandum:
EPA has not made an effects determination for sulfoxaflor. EPA is currently focusing most of its resources for assessing impacts to listed species on its registration review program for currently registered pesticides. EPA believes that, as a general matter, older pesticides present a greater degree of risk to listed species than most new chemistries, including sulfoxaflor, and that it is therefore environmentally preferable in most circumstances for EPA to assess the impacts of existing pesticides sooner in the process than newer pesticides that are designed to compete with more risky alternatives. EPA believes that is especially true for sulfoxaflor, where the alternatives include organophosphates, neonicotinoids and pyrethroids. As a result, EPA does not believe the environment or the public would be best served by delaying the registration of new uses for sulfoxaflor to complete consultation. Focusing the limited resources of EPA, the Fish and Wildlife Service and the National Marine Fisheries Service on completing a consultation on the effects of sulfoxaflor would by necessity come at the expense of putting more resources into evaluating – and consequently regulating, where appropriate – what EPA believes to be more toxic compounds, that, among other things, pose greater risk, to endangered species than does sulfoxaflor.
While it is clearly sensible for EPA and the Services to prioritize the limited resources available to make and to consult concerning effects determinations for endangered species by addressing existing pesticide classes that are likely to present the greatest risk before products with new chemistries that are intended to be more selective, it remains to be seen whether reviewing courts will be inclined to accept this type of rationale. In particular, it will be interesting to see whether the sufficiency of this approach to endangered species determinations becomes an issue in any future litigation regarding sulfoxaflor or other newly registered active ingredients.
By Lisa M. Campbell, Timothy D. Backstrom, James V. Aidala, and Lisa R. Burchi
On July 18, 2019, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a Federal Register notice announcing a final order denying the Pesticide Action Network North America’s (PANNA) and the Natural Resources Defense Council’s (NRDC) 2007 Petition requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos (Order). This Order constitutes final Agency action denying all of the Petitioners’ objections to EPA’s previous refusal to revoke the tolerances for chlorpyrifos. This Order also constitutes final administrative action concerning all parts of the 2007 Petition that were not previously addressed by EPA. Given the previous extensive chlorpyrifos litigation, this latest action by EPA will likely lead to further litigation challenging EPA’s decision to allow continued use of chlorpyrifos under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).
The FIFRA registrations and related tolerances for chlorpyrifos have a complicated regulatory and legal history, as discussed in previous blogs available here.
EPA’s new Order denies objections made by PANNA and NRDC under the FFDCA to EPA’s March 29, 2017, order denying the request by PANNA and NRDC that EPA revoke all tolerances for chlorpyrifos and cancel all chlorpyrifos product registrations. In the Order, EPA begins by summarizing its prior responses to the 2007 Petition, in which EPA denied each of ten claims raised in support of the Petitioners’ request that EPA revoke all chlorpyrifos tolerances and cancel all chlorpyrifos registrations. The ten claims are:
- EPA has ignored genetic evidence of vulnerable populations.
- EPA has delayed a decision regarding endocrine disrupting effects.
- EPA has ignored data regarding cancer risks.
- EPA’s 2006 cumulative risk assessment (CRA) for the organophosphates misrepresented risks and failed to apply the Food Quality Protection Act (FQPA) 10X safety factor.
- EPA over-relied on registrant data.
- EPA has failed to address properly the exporting hazard in foreign countries from chlorpyrifos.
- EPA has failed to incorporate quantitatively data demonstrating long-lasting effects from early life exposure to chlorpyrifos in children.
- EPA has disregarded data demonstrating that there is no evidence of a safe level of exposure during pre-birth and early life stages.
- EPA has failed to cite or incorporate quantitatively studies and clinical reports suggesting potential adverse effects below 10 percent cholinesterase inhibition.
- EPA has failed to incorporate inhalation routes of exposure.
EPA’s Order next focuses on the June 2017 objections to the March 29, 2017, Denial Order that were filed by several public interest groups and states. The three main objections, and EPA’s response, are as follows:
- Claims Regarding the Legal Standard for Reviewing Petitions to Revoke: Objectors assert that EPA’s Denial Order applied the wrong legal standard. Objectors assert that neither “scientific uncertainty” nor the October 2022 deadline for registration review under FIFRA Section 3(g), nor the widespread agricultural use of chlorpyrifos, provide a basis for denying petitions to revoke. Objectors claim that EPA has unlawfully left chlorpyrifos tolerances in place without making the safety finding required by the FFDCA.
- EPA Response: In its Order, EPA denies the objections related to Petitioners’ claims regarding neurodevelopmental toxicity, stating that the objections and the underlying Petition are not supported by valid, complete, and reliable evidence sufficient to meet the Petitioners’ burden under the FFDCA, as set forth in EPA’s implementing regulations. Specifically, EPA states that Objectors have not met their regulatory burden to provide “reasonable grounds” for revocation, including an assertion of facts to justify the modification or revocation of the tolerance (40 C.F.R. § 180.32(b)) or the initial evidentiary burden for persons seeking revocation to come forward with sufficient evidence to show that pesticide tolerances to be modified or revoked are not safe. After summarizing its review of available epidemiologic data, including feedback from the 2012 and 2016 FIFRA Scientific Advisory Panel (SAP) meetings, EPA states that “the epidemiologic studies are central to the Petitioner’s claims regarding neurodevelopmental effects, yet the Petitioners and Objectors rely only on summaries in publications to present their case. Petitioners have not presented the raw data from the epidemiology studies for consideration of their claims.” EPA “concludes that the information yet presented by Petitioners is not sufficiently valid, complete, and reliable to support abandoning the use of AChE inhibition as the critical effect for regulatory purposes under the FFDCA section 408” and also that Petitioners have “failed to meet their initial burden of providing sufficiently valid, complete, and reliable evidence that neurodevelopmental effects may be occurring at levels below EPA’s current regulatory standard and no information submitted with the objections addresses this shortcoming of the Petition.”
- Objections Asserting that EPA Has Found Chlorpyrifos to Be Unsafe: Objectors assert that EPA has previously found that chlorpyrifos tolerances are unsafe and has not disavowed those findings. Specifically, they claim that EPA has found that chlorpyrifos results in unsafe drinking water exposures and results in adverse neurodevelopmental effects to children and that EPA must therefore revoke the tolerances.
- EPA Response: EPA denies making any regulatory findings that chlorpyrifos tolerances are not safe, stating that its statements in its 2015 proposed tolerance revocation was not a final action. EPA states: “Proposed rules are just that -- proposals; they do not bind federal agencies. Indeed, EPA made clear it was issuing the proposal because of the court order, without having resolved many of the issues critical to EPA’s FFDCA determination and without having fully considered comments previously submitted to the Agency.” Regarding those objections related to drinking water, EPA states that since the Petition did not identify drinking water exposure as a basis for seeking tolerance revocation, the Objectors cannot now raise that concern as a basis for challenging EPA’s denial of the Petition. EPA also states: “The mere fact that EPA is considering the potential impact of chlorpyrifos exposures in drinking water in the Agency’s FIFRA section 3(g) registration review does not somehow provide Petitioners and Objectors with a vehicle for introducing that topic in the objections process on the Petition denial.” EPA instead will continue its FIFRA Section 3(g) registration review and complete its evaluation of drinking water exposures to chlorpyrifos, and address these issues in its upcoming registration review decision.
- Objections Asserting that the Denial Order Failed to Respond to Significant Concerns Raised in Comments: Objectors argue that EPA’s Denial Order committed a procedural error by failing to address significant concerns raised in the comments on EPA’s 2014 risk assessment and 2015 proposed revocation that EPA’s assessment fails to protect children. In particular, the Objectors focus on concerns raised in comments asserting that (1) EPA’s use of 10 percemt cholinesterase as a regulatory standard is not protective for effects to children’s developing brains; (2) EPA has not properly accounted for effects from inhalation of chlorpyrifos from spray drift and volatilization; and (3) EPA inappropriately used the Corteva physiologically based pharmacokinetic (PBPK) model to reduce inter- and intra-species safety factors because the model is ethically and scientifically deficient.
- EPA Response: EPA denies the objections claiming procedural error, stating it “has no obligation to respond to rulemaking comments in denying the Petition or responding to objections, both of which are adjudicatory actions that are not part of the rulemaking process. EPA also restated its prior response to the Petition that the “objections fail to meet burden of presenting evidence sufficiently valid, complete and reliable to demonstrate that chlorpyrifos results in neurodevelopmental effects that render its tolerances not safe.” EPA further “believes it is lawful and appropriate for it to consider federally enforceable chlorpyrifos product labeling restrictions in assessing the extent of bystander risk from spray drift under both the FFDCA and FIFRA.”
This latest EPA assessment appears to be more finely crafted than the earlier March 2017 response to the tolerance revocation Petition. EPA explains that it does not consider the epidemiology studies cited by the Petitioners to be persuasive sufficiently to change EPA’s fundamental approach to assessing chlorpyrifos risks. EPA notes that its current risk assessment utilizes the default 10X safety factor for infants and children specified by the FQPA, so any argument that it has not utilized this safety factor is moot. At the same time, EPA maintains that the epidemiology studies do not justify changing EPA’s point of departure for risk assessment, which remains the threshold for 10 percent acetylcholinesterase (AChE) inhibition. EPA states that there are significant problems with using the epidemiology studies for risk assessment, including lack of access to the underlying data, the absence of any known mechanism for neurodevelopmental effects below the threshold for AChE inhibition, and a lack of scientific consensus on a method for choosing an alternate point of departure based on the epidemiology studies. This interpretation of the epidemiology studies for chlorpyrifos will remain controversial and these studies will continue to be cited by those who seek to eliminate chlorpyrifos use.
EPA has also taken a position that the burden is on the Petitioners to support a petition to revoke tolerances with reliable data. What is less clear is “how much” evidence EPA considers sufficient to meet the threshold for tolerance revocation. Meanwhile, EPA will defer its assessment of possible neurodevelopmental effects of chlorpyrifos below the threshold for AChE inhibition pending completion of the registration review for chlorpyrifos. The deadline for EPA to complete registration review is October 1, 2022, although EPA states that it intends to expedite this process and to issue a proposed registration review decision by October 2020.
EPA also has included in its decision an intriguing discussion of some new animal studies for chlorpyrifos that purport to show low-level neurodevelopmental effects from chlorpyrifos. The California Department of Pesticide Regulation relied substantially on these new studies when it designated chlorpyrifos as a Toxic Air Contaminant. If these new chlorpyrifos studies are deemed credible, they could supplant efforts to use the chlorpyrifos epidemiology data in risk assessments and allow EPA to establish a new point of departure for chlorpyrifos that is not based on AChE inhibition. Rather than disregarding these new data, which were not submitted in support of the tolerance revocation Petition, EPA says affirmatively that it intends to review them in the pending registration review.
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 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 Lisa R. Burchi and Lisa M. Campbell
On January 3, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-01: Expanding Use of Pesticide Products Under Reevaluation. Under Notice 2018-01, effective immediately, DPR will not act upon an Application for Pesticide Registration or an Application to Amend a Pesticide Product if it determines the registration or acceptance would potentially “expand use” of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.
DPR states that it commences a reevaluation of an existing registered pesticide when it finds, based on an investigation of all reported episodes and information received, that a significant adverse impact to human health or the environment has occurred or is likely to occur. DPR states that the policy set forth in Notice 2018-1 is needed for pesticides under reevaluation because until DPR reviews existing data for substances under reevaluation, determines whether additional data to satisfy reevaluation data requirements must be submitted, and then receives and assesses additional data applicable to the reevaluation that can mitigate the concern that prompted the initiation of the reevaluation, DPR “is not in a position to determine that an expanded use will not cause a ‘significant adverse environmental impact,’ as required under its certified regulatory program (3 CCR section 6254).” Once the reevaluation process is completed, DPR states that it will then be in a position, in light of its reevaluation determination, to consider applications for product registration or amendment.
Scope of Notice 2018-1
DPR is currently reevaluating certain pesticide products containing the following active ingredients:
- Copper-based antifouling paints (copper oxide, copper hydroxide, and cuprous thiocyanate);
- Diazinon; and
- Nitroguanidine neonicotinoids (imidacloprid, thiamethoxam, clothianidin, and dinotefuran).
This notice applies to new pesticide products that include these active ingredients, including supplemental distributor registrations (subregistrations) and amendments to currently registered pesticide products, when “expanding use” of the active ingredient relevant to the concern that prompted the reevaluation.
Specifically, DPR states in Notice 2018-1 that it interprets the following types of actions, related to a new or amended product containing the active ingredient under reevaluation, as examples of “expanding use”:
- A proposed new pesticide product, including any Special Local Needs registration or Experimental Use Permit, with a label bearing uses or exposure scenarios relevant to the concern that prompted the reevaluation. This includes any product label that is identical or substantially similar to a currently registered product in California.
- Amendment of a currently registered product to add or modify uses or exposure scenarios relevant to the concern that prompted the reevaluation, even if such use is already on other currently registered pesticide products in California. Examples of such changes include:
- New or modified uses (e.g., new crops, pests, or use sites);
- New or modified use patterns (e.g., adding aerial, aquatic, soil applications, or outdoor use);
- Significant formulation changes (unless prompted by the reevaluation);
- Increased application rates or total use amount allowed (e.g., acreage or frequency of application); and
- Other label additions or changes that may increase pesticide exposure in a manner that is relevant to the basis for the reevaluation.
This notice does not preclude expanded use of a product if the expansion is not consistent with uses or exposure scenarios relevant to the concern that prompted the reevaluation. As an example, DPR states that an application containing an active ingredient that is under reevaluation over concerns regarding exposure to wildlife would not be precluded under this notice as an expanded use is if the product is labeled solely for indoor use, with no potential wildlife exposure.
DPR also acknowledges that a pest management or public health need could arise during a reevaluation that would support the issuance of an Emergency Exemption request under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In those cases, with regard to the potential applicability of Notice 2018-1, DPR states that it “will assess the request by relying on currently available information and risk mitigation strategies.”
DPR’s reevaluation process can take years to complete, so not only are pending affected submissions for products containing the active ingredients at issue effectively frozen, but future submissions for active ingredients newly entering the reevaluation process could be halted potentially for lengthy periods of time, despite the fact that DPR may ultimately determine that any identified “expanded uses” do not cause a significant adverse environmental impact. It is an initiative that many in industry are monitoring closely.
More information on other California DPR-related issues is available on our blog under key phrase California DPR.