Posted on December 08, 2022 by Lisa M. Campbell
By Lisa R. Burchi, James V. Aidala, and Dennis R. Deziel
On November 29, 2022, the U.S. Environmental Protection Agency (EPA) announced proposed new mitigation measures for 11 rodenticides, including measures to reduce potential exposures to three federally listed endangered and threatened species and one critical habitat. The mitigation measures are part of EPA’s goals outlined in its April 2022 Endangered Species Act (ESA) Workplan and one of the ESA pilots described in its November 2022 update.
Comments on the proposed interim decisions (PIDs) are due on or before February 13, 2023, in the following pesticide registration review dockets:
- Brodifacoum, EPA-HQ-OPP-2015-0767;
- Bromadiolone, EPA-HQ-OPP-2015-0768;
- Bromethalin, EPA-HQ-OPP-2016-0077;
- Chlorophacinone, EPA-HQ-OPP-2015-0778;
- Cholecalciferol, EPA-HQ-OPP-2016-0139;
- Difenacoum, EPA-HQ-OPP-2015-0769;
- Difethialone, EPA-HQ-OPP-2015-0770;
- Diphacinone (and its sodium salt), EPA-HQ-OPP-2015-0777;
- Strychnine, EPA-HQ-OPP-2015-0754;
- Warfarin (and its sodium salt), EPA-HQ-OPP-2015-0481; and
- Zinc Phosphide, EPA-HQ-OPP-2016-0140.
As background, in 2008, EPA issued a risk mitigation decision (RMD) for 10 rodenticides that set forth mitigation measures to reduce risks to human health and non-target organisms, including implementing minimum packaging size requirements for products on the consumer market (must be in packages one pound or less), prohibiting products intended for general consumers (i.e., homeowners or residential consumers) from containing second-generation anticoagulant rodenticides (SGAR), and requiring tamper- and weather-resistant bait stations for outdoor, above-ground placements where children, pets, and wildlife may be present. The 2009 RMD represented EPA’s final decision on the reregistration eligibility of rodenticide products at that time and constituted EPA’s final action.
The PIDs cover three first-generation anticoagulant rodenticides (FGAR), four SGARs, and four non-anticoagulant rodenticides. Strychnine (the 11th rodenticide) was not part of the 2008 RMD but is now included as part of EPA’s registration review of the rodenticide group.
The PIDs propose additional mitigation measures based on findings in the 2020 draft human health and ecological risk assessments (DRA) and comments submitted on the DRA. According to EPA, these measures are intended to reduce exposure to non-target organisms. Proposed measures include requiring bait to be placed in tamper-resistant bait boxes to ensure it is contained and requiring users to collect carcasses of rodents that may have consumed rodenticides to prevent further exposures to non-target organisms that could consume the carcasses. In addition, in its PIDs EPA proposes that all products, excluding those registered solely for use by homeowners, include label language directing users to access the web-based Bulletins Live! Two and follow the measures contained in any Endangered Species Protection Bulletin(s) for the area in which the user is applying the product.
EPA states the ESA workplan describes how it is developing early mitigation for a subset of species where EPA predicts a likelihood of a jeopardy or adverse modification finding for one or more of the registration review pilot pesticides if mitigation is not undertaken. One of these pilots is for rodenticides, which will focus on addressing effects to mammals and birds that consume rodenticide bait (primary consumers) and to birds, mammals, and reptiles that consume primary consumers (secondary consumers).
According to EPA, as part of its registration review ESA pilot for the rodenticides, EPA evaluated their potential effects on individuals and populations of Stephens’ kangaroo rat, Attwater’s prairie chicken, and the California condor and its designated critical habitat. EPA states it chose these three listed species because they represent species that may be affected by rodenticides through different routes of exposure (e.g., primary consumption by Stephens’ kangaroo rat and Attwater’s prairie chicken, secondary consumption by California condor). EPA’s draft evaluation determined that rodenticide use is “likely to adversely affect” these three species but predicted the proposed mitigations will protect them from likely “jeopardy” (i.e., potential impacts to the survival of listed species) and “adverse modification” of critical habitat. A “likely to adversely affect” determination means EPA reasonably expects that at least one individual animal of any of the three species may be exposed to one or more of the rodenticides at a sufficient level to have an adverse effect. While EPA has made predictions about the likelihood of jeopardy and adverse modification, the U.S. Fish and Wildlife Service (USFWS) is responsible for making the actual jeopardy/adverse modification findings for these species and has the sole authority to do so.
To focus the mitigations where they are most needed while retaining options for rodenticide users, EPA states the proposed mitigation measures for the three listed species would be targeted in specific geographic areas most relevant to the species. The PIDs include proposed mitigation measures to be included on the Bulletins Live! Two website for the species and the critical habitat of the California Condor. The draft evaluation for the three species and one critical habitat and associated mitigation measures are pilots for other listed species that may be similarly exposed and affected by rodenticides. In developing and applying mitigation measures for these species, EPA stated that it recognized that not all rodenticides have the same effects.
In addition to describing the pilot and the mitigation measures for the selected species, the PIDs also describe EPA’s plans for expanding those mitigation measures to the other approximately 90 listed species potentially affected by rodenticides. When this plan is issued in final, it will be known as the Rodenticide Strategy that EPA described in its November 2022 update to its ESA Workplan.
EPA also announced it intends to make effects determinations for all listed species available in a draft biological evaluation (BE), which EPA anticipates making available for public comment in November 2023. The BEs will contain EPA’s draft analysis of the potential effects of the rodenticides on listed species and their designated critical habitats and will identify mitigation measures for these species and critical habitats to avoid or minimize exposure from the rodenticides. EPA expects to complete the final BE for the rodenticides in November 2024.
If EPA’s final BE continues to find that rodenticide use is likely to affect adversely listed species or adversely modify their critical habitats, then EPA will initiate formal consultation and share its findings with the USFWS, which in turn can use the information in EPA’s BE to inform its biological opinions. If the USFWS determines in its final biological opinions that additional mitigations are necessary to address any jeopardy or adverse modification determination, or to address any incidental take, then EPA will work to ensure that any necessary registration or labeling changes are made.
Additional information on EPA’s rodent control pesticide safety review is available here.
The proposed interim decisions cover the full “rodenticide cluster” -- seven anticoagulant rodenticides and four non-anticoagulant rodenticides. Strychnine (the 11th rodenticide) was not part of the 2008 Risk Management Decision but is now included as part of EPA’s registration review of the rodenticide group.
EPA has determined that rodenticide use is “likely to adversely affect” three representative species but also predicts that the proposed mitigations will protect them from likely “jeopardy.” Note that while EPA has made predictions about the likelihood of jeopardy and adverse modification, the USFWS is responsible for making the actual jeopardy/adverse modification findings for these species and has the sole authority to do so. As stated above, EPA intends to make effects determinations for all listed species (about 90 species) available in a draft BE in November 2023, and EPA expects to complete the final BE for the rodenticides in November 2024. In short, this November 2022 action represents a mid-point, not a starting point or endpoint, for action on rodenticides, and EPA’s approach on addressing endangered species will be a good indicator of how well the ESA Workplan process and approach are working over the coming months.
Requiring bait to be placed in tamper-resistant bait boxes to ensure it is contained is a common, straightforward measure and generally follows current practices. Requiring users to collect carcasses of rodents that may have consumed rodenticides can be difficult to measure compliance and to enforce and also raises different public health concerns; we expect this approach to be debated further. In addition, the proposed interim decisions would require that all products -- excluding those registered solely for use by homeowners -- include label language directing users to access the web-based Bulletins Live! Two and follow the measures contained in any Endangered Species Protection Bulletin(s) for the area in which the user is applying the product. Understanding this process and the map for the user’s region specifically will be a process that applicators adjust to over time, but the quality and clarity of EPA’s assessments and maps will be important and need improvements. The Bulletins Live! Two system will need continuous investment and improvements to be effective, and linking all of these interactive processes (e.g., rodenticide strategy, ESA Workplan, web-based mapping and announcement systems) could prove cumbersome over time if not managed closely.
Overall, this continues the pesticide program’s march through the thicket of ESA decisions that must be made over the next many years. EPA is using its revised approach as outlined in earlier announcements regarding how it will attempt to comply with ESA as part of the registration and registration review process. The positive news is that EPA is starting to make progress on ESA compliance, which has long been discussed as part of program planning and in response to numerous ESA lawsuits over the past many years. Less clear is how EPA’s requirements will be able to be implemented and/or enforced, and how attempts to implement or comply with label changes might result in controversies among applicators and users of the affected pesticide products. The feasibility and acceptability of some label requirements are among the open questions about EPA’s new approaches to address this long-standing issue.
Posted on November 23, 2022 by Lisa M. Campbell
By James V. Aidala, Dennis R. Deziel and Heather F. Collins, M.S.
On November 16, 2022, the U.S. Environmental Protection Agency (EPA) announced it released an Endangered Species Act (ESA) Workplan Update (Workplan Update) that outlines major steps to increase protections for wildlife and regulatory certainty for pesticide users. The Workplan Update details how EPA will pursue protections for nontarget species, including federally listed endangered and threatened (i.e., listed) species, earlier in the process for pesticide registration review and other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. According to EPA, these early protections will help EPA comply with the ESA, thus reducing its legal vulnerability, providing farmers with more predictable access to pesticides, and simplifying the ESA-FIFRA process that, left unchanged, creates both significant litigation risk and a workload far exceeding what EPA has the resources to handle.
EPA states this update is a follow-up to EPA’s April 2022 ESA Workplan that addresses the complexity of meeting its ESA obligations for thousands of FIFRA actions annually. The ESA Workplan prioritizes certain FIFRA actions for ESA compliance, outlines how EPA will pursue early mitigation for listed species under FIFRA, and describes directions for expediting and simplifying the current pesticide consultation process.
As part of registering new pesticides or reevaluating pesticides during registration review, EPA has a responsibility under the ESA to ensure certain pesticide registrations do not jeopardize the continued existence of listed species or adversely modify their designated critical habitats. EPA states that it has seen in the past few decades an increase in litigation due to EPA’s failure to meet its ESA obligations when taking FIFRA actions. Over the next six years, existing court-enforceable deadlines will require EPA to complete ESA reviews for 18 pesticides -- the most EPA estimates it can handle during this period based on its current capacity and processes. Ongoing litigation and settlement discussions for other lawsuits cover dozens of additional pesticides and will likely fill the EPA’s ESA workload well beyond 2030. According to EPA, if its ESA efforts continue at this pace, a future court may decide to curtail drastically pesticide use until EPA meets its obligations. EPA believes this situation would be unsustainable and legally tenuous and provide inadequate protection for listed species and create regulatory uncertainty for farmers and other pesticide users.
The Workplan Update is EPA’s first update to the ESA Workplan and covers four main goals:
- Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.
- Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for many future conventional and biological pesticide registration and registration review actions to protect nontarget species. For each FIFRA action, EPA will consider this menu and propose, based on the risks and benefits of the particular pesticide, which specific measures to include on the pesticide label.
- Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture. Where needed, EPA may develop these measures to complement the generic FIFRA ecological mitigation described above.
- Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.
The first strategy described in EPA’s ESA Workplan is to “meet ESA obligations for FIFRA actions.” EPA states as part of its work to execute this strategy, it has identified a menu of Interim Ecological Mitigation measures it will use as a starting point to address pesticide risks to nontarget species during registration and registration review.
The menu of Interim Ecological Mitigation will include measures to reduce pesticide spray drift and pesticide runoff and will be considered as part of EPA’s upcoming proposed interim registration review decisions. While EPA intends for this set of Interim Ecological Mitigation measures to apply widely to many pesticides, EPA will consider the menu of options for any given pesticide depending on the level of risk that it poses to species and the exposure route.
EPA anticipates that this approach will more efficiently establish protections for nontarget species, including listed species, and standardize the protections across similar pesticides, in contrast to identifying mitigation measures pesticide by pesticide or species by species, as EPA has typically done in the past.
EPA states it will also work with registrants to add language on pesticide incident reporting, advisory language to protect insect pollinators, and language to most outdoor-use pesticide labels that directs users to reference Bulletins Live! Two, a website where pesticide users can find endangered species protection bulletins. These bulletins describe geographically specific use limitations to protect threatened and endangered species and their designated critical habitat.
EPA expects that once consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service is completed for any given outdoor-use pesticide, endangered species protection bulletins may be necessary for at least one listed species.
EPA also expects that working with registrants proactively to add the reference to Bulletins Live! Two to pesticide labels in advance of consultation will ultimately save EPA, state partners, and registrants time and resources by minimizing the number of amendments to labels.
The ESA Workplan Update also describes initiatives that, according to EPA, will help it and other federal agencies improve approaches to mitigation under the ESA and improve the interagency consultation process outlined in the ESA Workplan. These initiatives include EPA’s work to identify ESA mitigation measures for pilot species, incorporate early ESA mitigation measures for groups of pesticides (e.g., herbicides), and develop region-specific ESA mitigations.
Comments on the proposed set of interim mitigation measures and the proposed revisions to label language included in the Workplan Update appendix are due on or before January 30, 2023. Comments can be submitted at EPA-HQ-OPP-2022-0908.
This next phase of the ESA Workplan provides more detail about how EPA plans to impose various mitigation measures to meet its ESA obligations when registering a pesticide. The most favorable view of what EPA has presented is that it continues the march toward ESA compliance, which is long overdue, and provides more detail about the kinds of mitigation approaches it will place on pesticide labels to meet ESA requirements. The less favorable view here is that EPA has outlined a number of “off the shelf” mitigation options (buffers to reduce pesticide drift and water runoff), and EPA might impose such conditions in many instances where more careful analysis of usage data and site- or use-specific considerations might lessen the areas where such mitigation measures are needed.
EPA has stated previously as part of its earlier Workplan document, issued in April 2022, that using the present approaches EPA would complete only 5 percent of the ESA required reviews in about 18 years -- implying that the current approach would take about 360 years to complete. This next iteration of the Workplan, describing “early mitigation” strategies, is designed to reduce this unacceptable timeframe (360 years), but is likely to lead to fears among some stakeholders that in a “rush” to complete this work, EPA will make overly conservative label restrictions and reduce availability of the pesticide without increased species protections. Such concerns raise immediate ancillary concerns about stakeholder involvement in decision-making, compliance with what might be complicated label requirements, and enforcement of what is already typically a long list of label requirements for many current products. An example of such issues: one mitigation option example discussed is “do not use when rain is expected in the next 48 hours” -- which could raise issues concerning what or how compliance might be proven or enforced.
Again, to be sure, this next document about how EPA plans to make significant progress in meeting its ESA obligations continues the effort to convince courts that it is meeting its ESA obligations. As such, it represents a large step forward where in the past EPA was left with little progress or plans to present in court as part of litigation over ESA compliance. As it continues to reveal its plans and options, however, stakeholders will need to follow closely and consider the possible impacts of the Workplan and the resulting label proposals to follow.
Posted on September 28, 2020 by editor
Innovations in agricultural chemicals have revolutionized and enhanced food production, but with progress come new challenges. Agricultural chemicals can have widespread impacts on ecosystems and human health, and marginalized communities -- children and farmworkers in particular -- can be especially vulnerable. Manufacturers, regulatory agencies, public health experts, and nonprofit organizations are working to address these challenges head-on by developing new products and devising robust protective measures.
Recent changes in federal regulations include the Worker Protection Standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which expand the requirements for protecting agricultural workers from pesticide exposure. The Environmental Law Institute (ELI) presents "Pesticides, Farmworkers, Industry, and Environmental Justice," a webinar exploring the issues addressed in the new regulations and the implementation of these new obligations. James V. Aidala, Senior Government Affairs Consultant, Bergeson & Campbell, P.C. (B&C®), will moderate this discussion.
Posted on May 03, 2019 by Lisa M. Campbell
By Lisa M. Campbell and Heather F. Collins, M.S.
On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W. 84 Fed. Reg. 18993. The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food,” as EPA states was incorrectly implied by the previous regulatory text. EPA initially proposed this change on August 18, 2017 (82 Fed. Reg. 39399) because it agreed to do so in a settlement agreement with the American Chemistry Council (ACC) after ACC filed a petition for review of the 2013 final rule titled “Data Requirements for Antimicrobial Pesticides” (78 Fed. Reg. 26936 (May 8, 2013)) in the U.S. Court of Appeals for the District of Columbia Circuit. Specifically, EPA agreed to make this correction to “make the language consistent” with the U.S. Food and Drug Administration’s (FDA) policy set forth in FDA’s “Guidance for Industry, Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Final Guidance. April 2002.” EPA states that the change is intended to “enhance understanding of the data required to support an antimicrobial pesticide registration and does not alter the burden or costs associated with these previously promulgated requirements” and that it is not establishing “any new data requirements or any other revisions (substantive or otherwise) to existing requirements.” The final rule will become effective on July 2, 2019.
Posted on April 16, 2019 by Lisa M. Campbell
By Lisa M. Campbell and James V. Aidala
On April 8, 2019, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket on the draft toxicological profile for glyphosate. 84 Fed. Reg. 13922. ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile. Comments are due by July 8, 2019.
The draft profile includes a chapter on glyphosate’s potential for human exposure, which states the following in the overview:
- “Glyphosate has not been identified in any of the 1,832 hazardous waste sites that have been proposed for inclusion on the [U.S. Environmental Protection Agency (EPA)] National Priorities List (NPL) (ATSDR 2015). However, the number of sites evaluated for glyphosate is not known.”
- “Occupational and residential exposure is a result of glyphosate’s use in agricultural, nonagricultural, industrial, and residential settings. The highest potential for dermal, inhalation, and ocular exposure is expected for pesticide applicators, farm workers, and home gardeners who use herbicides containing glyphosate.”
- “The general population is exposed to glyphosate via ingestion of crops, plants, and foods with residues of this chemical. Residential exposure may occur via inhalation, dermal contact, and/or ocular contact during mixing or application of consumer products containing glyphosate or by coming into contact with crops, soils, or water to which glyphosate-containing products have been applied.”
- “Occupational exposure to glyphosate may occur via inhalation, dermal contact, and/or ocular contact during manufacture, transport, mixing, loading, application, and disposal processes. Accidental oral exposure may occur via unintentional ingestion. Dermal contact appears to be the major route of exposure to glyphosate for individuals involved in its application.”
- “Glyphosate mainly enters the environment as a direct result of its herbicidal use. Fate of this chemical in the environment includes degradation, transport, and partitioning processes, which are governed by its physicochemical properties and by abiotic or biotic degradation under certain environmental conditions. Glyphosate is a nonvolatile, highly polar, non-residual herbicide that has low potential for environmental persistence and is unlikely to bioaccumulate.”
ATSDR’s draft profile and the peer review which will follow can be expected to become part of the larger debate about the potential risks of glyphosate. Meanwhile, EPA continues its work on the registration review of the herbicide. In 2017, EPA evaluated the carcinogenic risk of glyphosate, and released its draft human health and ecological risk assessments. See our December 19, 2017, blog item EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment for more information. After the public comment period for the draft human health and ecological risk assessments ended in April 2018, EPA officials have stated they hope to complete the registration review sometime this year.
Posted on March 15, 2019 by Lisa R. Burchi
By Lisa R. Burchi
On March 7, 2019, in the Court of Justice of the European Union (EU), the Eighth Chamber of the General Court issued two judgments in cases regarding access of confidential information related to glyphosate. One of these decisions (Tweedale v. EFSA, Case T-716/14) related to a 2014 request for two toxicity studies that were “key studies” in the determination of glyphosate’s acceptable daily intake (ADI). The second decision (Hautala et al. v. EFSA, Case T-329/17) related to a request from Members of the European Parliament for access to parts (i.e., “material, experimental conditions and methods” and “results and discussions”) of 12 unpublished carcinogenicity studies, described as the “‘most crucial’ studies for the peer review and [EFSA’s] conclusion that glyphosate is unlikely to pose carcinogenic hazard to humans.” Partial access to those studies (i.e., raw data and findings aggregated in tables and figures) had been granted in an earlier 2016 decision.
A prior November 21, 2018, case related to glyphosate (Stichting Greenpeace Nederland and Pesticide Action Network Europe v. European Commission, Case T-545/11 RENV) and the General Court/Fourth Chamber’s judgment to prevent applicants from receiving access to information on the degree of purity of the active substance glyphosate, as well as the identity and quantities of impurities is discussed here. In contrast to the Stichting decision, where access was denied, the court in the March 7, 2019, decisions annulled prior decisions dated October 16, 2017 and March 14, 2017, that refused access to the requested information.
Article 4(2) of Regulation No. 1049/2001 (regarding public access to European Parliament, Council and Commission documents) provides that access to documents should be refused where disclosure would undermine, in part, commercial interests of a natural or legal person, including intellectual property, unless “there is an overriding public interest in disclosure.”
Article 6(1) of Regulation No. 1367/2006 (regarding the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies) provides that, with regard to Regulation No. 1049/2001 Article 4(2), “an overriding public interest in disclosure shall be deemed to exist where the information requested relates to emissions into the environment.” Recital 15 of Regulation No. 1367/2006 also provides: “The grounds for refusal as regards access to environmental information should be interpreted in a restrictive way, taking into account the public interest served by disclosure and whether the information requested relates to emissions in the environment.”
Taken together, the court stated: “that means that an EU institution, hearing a request for access to a document, cannot justify its refusal to divulge it on the basis of the exception relating to the protection of the commercial interests of a particular natural or legal person for the purposes of Article 4(2), first indent, of Regulation No 1049/2001, where the information contained in that document constitutes information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006.”
The General Court/Fourth Chamber thus addressed whether the information contained in the applicants’ requests constituted information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation 1367/2006.
In the March 7, 2019, decisions, the General Court/Fourth Chamber held that EFSA cannot argue that the requested studies do not concern actual emissions or the effects of actual emissions because “an active substance contained in plant protection products, such as glyphosate, in the course of normal use, is intended to be discharged into the environment by virtue of its function, and its foreseeable emissions cannot, therefore, be regarded as purely hypothetical.” The court further held: “It is apparent from that case-law that the concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006 is not limited to information which makes it possible to assess the emissions as such, but also covers information relating to the effects of those emissions.” The Court further stated that the “concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006 must be interpreted as covering not only information on emissions as such, namely information concerning the nature, composition, quantity, date and place of those emissions, but also data concerning the medium to long-term consequences of those emissions on the environment.”
The court also found that EFSA’s “argument that the conditions in which the requested studies were carried out are not linked to emissions is irrelevant. What matters is not the conditions in which the requested studies were carried out, but their purpose.” In these cases, the purpose to define a no observed adverse effect level (NOAEL) from which the ADI was calculated, or to determine the carcinogenic effects of exposing humans to glyphosate, “must be regarded as constituting information which ‘relates to emissions into the environment; for the purposes of Article 6(1) of Regulation No. 1367/2006.”
In sum, the court in Tweedale concluded:
- It follows from the foregoing that the exception relating to the protection of commercial interests, provided for in Article 4(2), first indent, of Regulation No 1049/2001, cannot be relied upon in order to object to the disclosure of the requested studies which are regarded as information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006.
The court in Hautala further stated that “an overriding public interest in disclosing the studies is deemed to exist, and EFSA could not refuse to disclose them on the ground that that would have an adverse effect on the protection of the commercial interests of the owners of the requested studies for the purposes of Article 4(2), first indent, of Regulation No 1049/2001.”
These decisions support transparency but also may add confusion regarding any limitations placed on the scope of what is to be considered “information on emissions into the environment.” The prior 2018 Stichting decision refused access to information on the degree of purity of the active substance glyphosate, as well as the identity and quantities of impurities, finding that such information is excluded from the concept of “information relating to emissions into the environment:”
- Since the use, the conditions of use and the composition of a plant protection product authorised by a Member State on its territory may be very different from those of products evaluated at EU level during the approval of the active substance, it must be held that the information in the document at issue does not relate to emissions whose release into the environment is foreseeable and has, at the very most, a link to emissions into the environment.
These decisions may expand the scope of information that relates to emissions into the environment, including, for example, “data concerning the medium to long-term consequences of those emissions on the environment.” For information that is determined to constitute information that “relates to emissions into the environment,” the decisions appear to create a presumption for disclosure that cannot be countered based on the exception relating to the protection of the commercial interests of a particular natural or legal person.
Companies should continue to monitor these decisions closely, as guidance continues to evolve regarding the scope of disclosure.
More information on glyphosate issues is available on our blog.
Posted on June 04, 2018 by editor
By Jason E. Johnston, M.S.
On May 23, 2018, the U.S. Environmental Protection Agency (EPA) held an “Environmental Modeling Public Meeting” (EMPM). As stated in the April 12, 2018, Federal Register notice announcing the meeting, the “EMPM provides a public forum for EPA and its stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for pesticide risk assessments in a regulatory context.” The overall theme of the EMPM was the quantitative use of surface water monitoring data.
The morning session featured a series of presentations by representatives from EPA, the U.S. Geological Survey (USGS), and the Washington State Department of Agriculture concerning the development of a framework to use surface water monitoring data quantitatively in pesticide risk assessments. A major focus of the presentations was the exploration and evaluation of the capabilities of the USGS recently-developed model SEAWAVE-QEX to improve the robustness of surface water monitoring datasets so that they might be used in pesticide risk assessments. Further public presentations on the evaluation and development of the framework are scheduled at the American Chemical Society meeting to be held on August 19-23, 2018, in Boston, Massachusetts. There are plans to hold a Scientific Advisory Panel meeting on the framework in 2019, but no exact date has been set.
The afternoon session consisted of presentations by representatives of the registrant community. Topics addressed included developments in the use of surface water monitoring data in quantitative risk assessment, a statistical analysis of non-targeted monitoring data at the watershed scale, the creation of a curated database of water and sediment monitoring data for synthetic pyrethroids, the use of high-resolution spatial and temporal monitoring data to parameterize watershed scale drift exposure predictions, and an evaluation of model predictability using monitoring data and refined pesticide use at the watershed level.
Presentations from the May 23, 2018, EMPM will soon be posted to Docket No. EPA-HQ-OPP-2009-0879, accessible at www.regulations.gov.
Registrants should monitor these activities, as this effort at EPA represents a potential shift away from the current reliance exclusively on estimated water concentrations in quantitative human health and ecological risk assessments.
Posted on February 15, 2018 by Lisa M. Campbell
By Lisa M. Campbell and Lisa R. Burchi
On February 12, 2018, the U.S. Environmental Protection Agency (EPA) announced it has reached an agreement with Syngenta Seeds, LLC (Syngenta), a pesticide company in Hawaii, to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) at its farm in Kekaha, Kauai. The settlement includes two penalty components: a $400,000 Supplemental Environmental Project (SEP) for worker protection standard (WPS) training; and $150,000 as a civil penalty.
The Consent Agreement and Final Order (CAFO), issued on February 7, 2018, states the parties are resolving alleged violations under FIFRA Section 12(a)(2)(G) from the use of the registered restricted-use pesticide Lorsban Advanced on an agricultural establishment in Kekaha, Hawaii, “in manners inconsistent with its labeling by not complying with applicable Worker Protection Standard regulations.” Syngenta neither admitted nor denied the allegations but consented to the assessment of the civil penalty and to the other conditions in the CAFO.
EPA’s Press Release states that under the settlement, Syngenta “will spend $400,000 on eleven worker protection training sessions for growers in Hawaii, Guam, and the Northern Mariana Islands.” Specifically, the SEP states it “is intended to assist and provide compliance tools to small-scale growers of agricultural plants that face compliance challenges based on cultural, literacy, or language considerations, and/or geographic isolation.” Further, Syngenta will “also develop compliance kits for use at these trainings and for wider distribution in the agricultural community in English and four other languages commonly spoken by growers and farmworkers in the training locations -- Mandarin, Korean, Tagalog, and Ilocano.” These compliance kits will include the following practical resources, among others:
- Summary documents with corresponding videos addressing the major compliance topic areas within the WPS;
- Worker training resources including, but not limited to, training outlines with materials, tailgate training toolkits, and sign-in sheets; and
- Sample WPS company policies and procedures.
This CAFO and in particular the SEP will be interesting to monitor considering EPA’s recent WPS revisions that became effective on January 2, 2017, and the additional proposed revisions for which comments are expected to be solicited.
More information on FIFRA enforcement issues is available on our blog under key word enforcement. Information on Syngenta’s 2016 CAFO regarding label violations is available in our blog item Syngenta Settles with EPA on Alleged Label Violations.
Posted on January 11, 2018 by Lisa R. Burchi
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.
Posted on January 04, 2018 by Lisa M. Campbell
By Lisa M. Campbell and Timothy D. Backstrom
On December 20, 2017, the U.S. Court of Appeals for the Ninth Circuit issued an order in LULAC v. Pruitt, Case No. 17-71636, a case challenging an order denying administrative petitions to revoke the tolerances and cancel the registrations for chlorpyrifos. The court’s order includes actions concerning two pending motions. The court has denied a motion by the U.S. Environmental Protection Agency (EPA) and Administrator Pruitt (Respondents) to dismiss the case for lack of jurisdiction while granting a motion by League of United Latin American Citizens (LULAC), et al. (Petitioners) to expedite briefing and hearing in the case. More information on these two motions is available in our blog item “NGOs and Farmworkers File Motion for Expedited Briefing and Hearing in Chlorpyrifos Litigation.”
In support of their August 21, 2017, motion to dismiss the case for lack of jurisdiction, Respondents argued that the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Petitioners to exhaust their administrative remedies by submitting formal objections to the order denying their request to revoke the tolerances for chlorpyrifos and then waiting for EPA to issue a final order before they may seek judicial review. The Petitioners argued in response that requiring exhaustion in this instance would be “futile,” and that the court should also consider reviewing the EPA order under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), because EPA has declined to cancel the registrations for chlorpyrifos. In response, Respondents argued that Petitioners have not shown that requiring exhaustion of administrative remedies would be futile, and that 21 U.S.C. § 346a(h)(5) explicitly prohibits judicial review of any order concerning pesticide tolerances under any other statute, including FIFRA.
After the motion to dismiss was fully briefed, the court summarily denied it, but also characterized that denial as “without prejudice to renewing the arguments in the answering brief.” The court also denied a motion by the Petitioners for oral argument concerning the pending motion to dismiss. These two actions indicate that the court has decided to defer argument and resolution of the jurisdictional issues presented by the motion to dismiss until briefing and argument on the merits.
The court also granted an October 13, 2017, motion by the Petitioners to expedite briefing and hearing in the case. Petitioners submitted this motion to expedite because they contend that the refusal of EPA to revoke the tolerances and cancel the registrations for chlorpyrifos is causing ongoing harm even though EPA “did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.” The court set the following expedited briefing schedule: Petitioners’ opening brief is due January 23, 2018; Intervenors’ brief(s) are due February 6, 2018; Respondents’ answering brief is due March 8, 2018; Petitioners’ optional reply brief is due 28 days after service of Respondents’ brief; and Intervenors’ optional reply brief(s) are due 42 days after service of Respondents’ brief. The court also directed the Clerk to “calendar this case [for argument] as soon as possible upon completion of briefing.”
The current actions of the court should be viewed in the context of the prior decision by this same court to issue a writ of mandamus that required EPA to take action on pending petitions to cancel the registrations and revoke the tolerances for chlorpyrifos after what Petitioners claimed was a quite protracted administrative delay, and the subsequent decision by EPA under Administrator Pruitt to defer final action on chlorpyrifos, after the prior Administration had proposed to take the actions sought by the Petitioners. By granting the motion to expedite, and also by deferring the ultimate disposition of the jurisdictional issues raised by EPA, the court appears to have given the Petitioners a prompt and full opportunity to explain why judicial intervention at this stage of the administrative process is warranted. Nevertheless, because the jurisdictional arguments made by EPA are supported by substantial precedent, it could prove difficult for the Petitioners ultimately to overcome these arguments.
More information on the chlorpyrifos litigation and related matters is available on our blog under key word chlorpyrifos.