By Timothy D. Backstrom, Lisa M. Campbell, and James V. Aidala
In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies. Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other neonicotinoids. The Petitioners in this case were various trade organizations representing commercial beekeepers, as well as some individual beekeepers. The registrant Dow AgroSciences LLC (Dow) intervened in the action.
EPA granted an unconditional registration for sulfoxaflor on May 6, 2013, subject to a variety of risk mitigation measures, including a lower application rate, longer intervals between applications, and certain crop-specific label restrictions. EPA had previously proposed to issue a conditional registration for sulfoxaflor in January 2013, citing pollinator data gaps that could be addressed by requiring Dow to conduct and submit further studies. Under that proposal, use of sulfoxaflor would have been allowed at a reduced application rate during the time needed to complete data development. The court found that the subsequent decision by EPA to register unconditionally sulfoxaflor was not supported by substantial evidence, as required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 16(b), both because EPA failed to adhere to its own scientific methodology and because the rationale that EPA provided for granting an unconditional registration could not be reconciled with the analysis upon which EPA based its prior proposal to register conditionally sulfoxaflor.
EPA evaluated the potential risk to bees and bee colonies from sulfoxaflor use utilizing the Pollinator Risk Assessment Framework, a scientific risk assessment methodology developed after consultations between EPA, Canada’s Pest Management Regulatory Agency, and the State of California, and presented by EPA to the FIFRA Scientific Advisory Panel in 2012. The court found that the rationale provided for EPA’s unconditional registration decision could not be reconciled with findings that EPA itself made using this methodology or with the rationale EPA provided for its prior proposal to issue a conditional registration. EPA had decided it was necessary to proceed to Tier 2 of the pollinator risk assessment after reviewing risk quotients and residue data in Tier 1 of the assessment. EPA found the available data for Tier 2 to be insufficient to allow indefinite use of sulfoxaflor, even at a reduced application rate. The court could not reconcile this finding with the subsequent decision to grant an unconditional registration, even with the specified mitigation measures. The court found that “given the precariousness of bee populations, leaving the EPA’s registration of sulfoxaflor in place risks more potential environmental harm than vacating it.” The court stated that “EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.”
EPA argued that with a reduced application rate, the risk quotients and residue analysis in Tier 1 was “close enough” to sufficient to avoid the specified quantitative trigger for a Tier 2 analysis, thereby rendering any deficiencies in the available Tier 2 data irrelevant. The court effectively stated in response that close enough is not good enough, citing another recent Ninth Circuit decision in which a risk concern that is triggered by a margin of exposure less than or equal to 1000 was held to be triggered when the margin was exactly 1000. Thus, this court once again placed EPA on notice that it must follow its own methodology with precision, and that EPA cannot justify deviations from its own methodology by simply stating that it is exercising expert judgment.
This is an unusual case because the registration of a new pesticidal active ingredient has been vacated on substantive as opposed to procedural grounds. The court’s rationale reflects a lack of judicial deference to what EPA typically refers to as the scientific “weight of the evidence.” While the term itself does not appear in the opinion, the court is insisting that EPA must follow its standard methodology without allowing for any deviations based on professional judgment. Although in this instance the court has supported the position of opponents of pesticide use, judicial reluctance to accept scientific “weight of the evidence” conclusions could also make it harder for EPA to impose additional restrictions when new but inconclusive evidence appears.
This case could cause EPA to be more explicit in adding procedures to its standard analytic methodologies that allow deviations from the methodology based on professional judgment. The case could also cause EPA to reconsider its recent reluctance to avoid issuing conditional registrations and its preference for unconditional registrations for new active ingredients. In any case, decisions that afford EPA less discretion to use “weight of the evidence” reasoning when basing scientific conclusions on less than conclusive data or studies could have an impact on a number of EPA practices and policies involving interpretation of scientific data.
By Lisa R. Burchi and Lisa M. Campbell
On June 16, 2015, the California Superior Court for the County of Almeda denied the petition of the Pesticide Action Network North America, et al. (PANNA) for a writ of mandate to direct the California Department of Pesticide Regulation (DPR) to set aside and vacate its final decisions approving amended registrations of Dinotefuran 20SG manufactured by Mitsui Chemicals Agro and Venom manufactured by Valent USA.
The active ingredient in both products at issue, dinotefuran, is a neonicotinoid pesticide that has been subject to additional reviews and labeling requirements with regard to its impact on pollinating bees on the federal and state level. PANNA argued, in part, that under the California Environmental Quality Act (CEQA), DPR should not have approved the amended labels because it had not developed an Environmental Impact Report (EIR) describing the potential environmental impacts, analyzing direct, indirect, and cumulative impacts, and analyzing alternatives.
The court held as a matter of law that “to give effect to CEQA’s current policy goals as developed since 1979 in the Public Resources Code, in the CEQA Guidelines and in case law, that the court must read the DPR’s regulations as requiring that the DPR apply current CEQA analysis in deciding whether to register pesticides.” That does not, however, require DPR to comply with all of CEQA’s documentation requirements; instead, DPR’s environmental documentation is required to “address only those significant adverse environmental effects that can reasonably be expected to occur, directly or indirectly, from implementing the proposal.”
With regard to the standard of review, the court found that DPR’s decision is in the nature of an EIR, which required the court to review the adequacy of the decision for substantial evidence, and not, as PANNA had argued, the functional equivalent of a negative declaration that would have triggered a “fair argument” review standard. The court then found there was substantial evidence in the administrative record supporting DPR’s decision that the proposed mitigation measures will eliminate any significant environmental impact. The court held that the record supported DPR’s assertion that the product labels provide necessary environmental protections, noting, for example, that EPA’s conclusion that the federal labeling is adequate to protect bees is substantial evidence to support DPR’s “identical conclusion.” The court further held that DPR was not required to consider the feasibility of alternatives.
Since the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts a state from imposing label requirements that are different from the U.S. Environmental Protection Agency (EPA)-approved label, the court noted that DPR’s decision was either to register the products consistent with EPA’s approved labels or not register the products for use in California. Although DPR’s failure to conduct a risk-benefit analysis was not argued before the court, the decision, by way of dicta, noted that the “record suggests that the DPR conducted a de facto risk-benefit analysis and did not actually conclude that the labeling on the Insecticides would mitigate all adverse affect on bees.” Instead, the court suggests DPR’s risk-benefit analysis was based on the fact that under FIFRA, the only alternative would be to deny the registrations and that would be infeasible considering economic, social, or other considerations.
The decision is a significant judgment regarding DPR’s ability to make decisions regarding label amendments and the court’s ability to review such decisions. It appears likely an appeal will be filed. It is also important to note that DPR’s reevaluation of neonicotinoids is still pending -- DPR is required under AB 1789 (codified at Food and Agricultural Code Section 12838(a)) to issue a determination before July 1, 2018, regarding the neonicotinoid registrations and to adopt any control measures determined to be necessary to protect pollinator health.
By Lisa M. Campbell and James V. Aidala
On May 8, 2015, in El Comite Para El Bienestar De Earlimart v. EPA, a Panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for review filed by several groups that the court describes as “community organizations” who challenged the U.S. Environmental Protection Agency’s (EPA) 2012 approval of California State Implementation Plan (SIP) elements under the Clean Air Act (CAA), including its related approval of certain fumigant regulations. This challenge was previously discussed in our blog post "Ninth Circuit to Consider Civil Rights Issue in Review of California SIP".
Of particular interest in the case is the contention before the court that “EPA failed to secure necessary assurances from California that its proposed rules would not violate Title VI of the Civil Rights Act by exposing Latino schoolchildren to a disparate impact from pesticide use.” The court rejected this and other contentions by the community groups.
The court’s findings with regard to the alleged Civil Rights violation state a standard that appears to defer greatly to EPA and its review of the record. More specifically, the court found with regard to the claimed Civil Rights Act violation that “EPA explained that this evidence failed to draw any connection between the proposed rules and a potential disparate impact,” and that EPA “fulfilled its duty to provide a reasoned judgment because its determination was cogently explained and supported by the record.”
By way of background with regard to the Civil Rights Act claim, the petitioners argued that EPA’s determination that California provided assurances that no federal or state law prohibits the SIP approval was arbitrary and capricious because EPA failed to consider evidence claimed to support a violation of Title VI of the Civil Rights Act. This claim rested on an EPA finding of a Title VI violation in connection with an earlier administrative complaint, referred to as the Angelita C. complaint, which was filed with the EPA Office of Civil Rights in 1999. There, Latino parents and schoolchildren alleged that schools with high percentages of Latino children were disparately affected by the California Department of Pesticide Regulation’s (DPR) renewal of the registration for methyl bromide, a fumigant pesticide. EPA concluded in that action that there was support for “a preliminary finding of a prima facie Title VI violation,” and EPA and DPR entered a settlement agreement in 2011.
Petitioner argued that EPA’s findings in Angelita C., and evidence that it claimed to demonstrate that pesticide use had not gone down since EPA completed its original review, supported the claimed Title VI violations that are the subject of the Ninth Circuit petition, and further that EPA did not do enough to determine that California had satisfied its burden to provide assurances of compliance with federal law. The Ninth Circuit decision states in this regard that the petitioner “effectively contends the EPA should have evaluated California’s assurances the same way the EPA would have to deal with a pending Title VI complaint setting forth allegations of a current violation.”
The court states: “El Comite’s argument fails because it misconstrues the EPA’s burden regarding the ‘necessary assurances’ requirement. The EPA has a duty to provide a reasoned judgment as to whether the state has provided ‘necessary assurances,’ but what assurances are ‘necessary’ is left to the EPA’s discretion.” The court further found: “El Comite provided no proof of a current or ongoing violation. It merely provided evidence of the earlier violation, and pointed to continued pesticide use since that time. The EPA explained that this evidence failed to draw any connection between the proposed rules and a potential disparate impact. The EPA fulfilled its duty to provide a reasoned judgment because its determination was cogently explained and supported by the record.”
The decision in this case is of significant interest to many who have been observing the emerging trends regarding environmental justice issues arising in connection with pesticide applications. This concern may grow larger as EPA continues and expands its evaluations of the potential bystander risks from pesticide use, potentially leading to additional restrictions for certain pesticides in the future.
By Lisa M. Campbell and James V. Aidala
On April 9, 2015, the California Department of Pesticide Regulation (DPR) held the first of a planned series of workshops intended to help DPR develop “regulation concepts” for possible notifications prior to field fumigations. The presentations and video from that workshop are now available on DPR’s website.
DPR’s presentation at the workshop focused on the background that it believes supports the consideration of a notification requirement, and on current methyl bromide notification regulations and fumigant labeling requirements that it believes potentially could be used as a foundation to assist in the development of a rulemaking concept for soil-applied field fumigants.
In addition, DPR considered whether the concept can be reconciled with the current label requirements as emergency preparedness and response requirements, or maintained as a separate “right-to-know” requirement. DPR recommended expanding notification to all field fumigations, including applications of chloropicrin, 1,3-dichloropropene, methyl bromide, or pesticides that generate methyl isothiocyanate.
This potential regulatory development is of significant interest to pesticide registrants in general. The application of a right-to-know model to pesticide applications, pursuant to which growers and applicators would have to notify those in a defined proximity to the planned pesticide application, would have far-reaching ramifications. DPR’s further development of this potential regulation should be monitored closely.
Of note are similar notification schemes reportedly under consideration by the U.S. Environmental Protection Agency (EPA) as part of its pollinator protection proposals. EPA staff has spoken of how one essential component of any pollinator protection program will be some kind of notification scheme for beekeepers, or at least commercial beekeepers, who have hives in the vicinity of the use area for certain pesticides. As that issue evolves, it will invite comparison with EPA’s position on other requirements for mandatory notification, where generally EPA has not supported blanket federal requirements for notification of nearby pesticide applications. This development in the pollinator area could lead to reconsideration at the federal level regarding broader advance notification requirements for specified pesticide applications.
By Lisa M. Campbell and Lisa R. Burchi
On February 27, 2015, the California Department of Pesticide Regulation (DPR) released California Notice 2015-3, entitled Concurrent Submission of Pesticide Products to the Department of Pesticide Regulation and the U.S. Environmental Protection Agency. In this Notice, DPR describes the four types of applications that may be submitted concurrently to DPR and to the U.S. Environmental Protection Agency (EPA), the procedure applicants should follow to request concurrent submission, and how DPR will process such requests.
This notice supersedes California Notice 2005-10, and there are some changes. For example, Notice 2015-3 now includes a process for an applicant to seek concurrent submission when the application is not one of the four specified types for which concurrent submission is permitted. Under this new procedure, the applicant must send a letter requesting approval to the Pesticide Registration Branch Chief before submitting an application to DPR and provide the following: (1) a statement that the product/amendment is not yet federally registered or accepted; (2) a request for concurrent acceptance of the application; and (3) justification with supporting documentation for the concurrent submission request (e.g., no other effective alternatives available for a specific pest problem). In addition, regarding data submissions with an application, DPR now states clearly: “All data and information required by California statutes and regulations, including all data and information submitted to U.S. EPA, must still be submitted with your California registration request.”
By Lisa M. Campbell and Susan Hunter Youngren, Ph.D.
The California Department of Pesticide Regulation (DPR) announced on February 26, 2015, a revision to the process for evaluation of the potential for a pesticide to move off-site into surface water when the pesticide is used in an urban area. The former evaluation method followed the U.S. Environmental Protection Agency (EPA) approach with California specific parameters. This revision will continue to use the EPA approach but allow incorporation of a module specific for California urban settings.
Potential adverse impacts on surface water from use of pesticides are assessed in California by DPR’s Environmental Monitoring Branch’s Surface Water Protection Program (SWPP) using EPA methodology. The SWPP uses the EPA evaluation method for proposed agricultural pesticide registrations based on PE5 (PRZM-EXAMS version 5) and Tier 2 modeling scenarios but there have been no consistent methods for assessing potential pesticide runoff on impervious surfaces in an urban setting. The new California urban module includes the following improvements that are designed to be further representative of urban conditions in California:
* Introduction of four types of surfaces by permeability and water sources;
* Consideration of pesticide transport induced by dry-weather runoff from impervious surfaces;
* Separation of impervious and pervious portions in the modeling scenarios;
* Use of prescheduled lawn irrigation;
* Characterization of residential and commercial/industrial areas to reflect California urban conditions; and
* Aggregations of water, sediment, and pesticide yields for the urban watershed.
The urban model is designed particularly for evaluating pesticides applied outdoors in areas with large amounts of impervious surfaces such as residential areas, commercial/industrial facilities, and highway and road rights-of-way applications. Pesticide products of interest would be those that have the potential for impact to surface waters through overspray to impervious surfaces in these areas
By Lisa M. Campbell
The California Department of Pesticide Regulation (DPR) recently issued its Progress Report 2012-2014, which highlights DPR’s view of achievements under the leadership of Director Brian Leahy. Among the achievements noted are the following; others are also discussed in the report.
• Restricting sales of Second Generation Anticoagulant Rodenticides (SCAR). This action is described as having been “the catalyst for a national change, as the manufacturer agreed with U.S. EPA to phase out these products after DPR’s action.”
• Implementing surface water regulations for pyrethroids. This action is described as “an aggressive preventative measure for environmental protection starting at the first point of pesticide applications.”
• Committing more than $3 million in research for alternatives to field fumigants since 2012 and “reducing risks to the public from field fumigations,” as well as “protecting workers and the public from structural fumigations.”
• Efforts to reduce pesticide use in schools and child care centers.
• Collecting air monitoring data, regulating volatile organic compounds, as well as a number of other actions addressing environmental monitoring.
• Efforts to reevaluate neonicotinoids.
The Progress Report highlights and achievements reflect well many DPR priorities and the direction DPR is continuing to forge on a number of issues, some of which are subject to significant controversy.
By Lisa R. Burchi
The California Department of Pesticide Regulation (DPR) has extended, from February 27, 2015, to Friday, March 13, 2015, the submission of written comments following DPR’s January 14, 2015, Registration Fee Workshop where DPR discussed the potential increase in registration fees for pesticide products pursuant to Food and Agricultural Code (FAC) § 12812(a).
Under the proposal, DPR would increase fees for applications and renewals from $750 to $1,150, decrease fees for certain label amendments supported by scientific data from $100 to $25, and create a new fee of $25 for label amendments not supported by scientific data, including substantive label amendments, non-substantive label amendments, label changes required by the U.S. Environmental Protection Agency or any other federal or state agency, amendments to the formulation of the pesticide product, and notifications.
By Lisa M. Campbell and Timothy D. Backstrom
On February 12, 2015, the Ninth Circuit Court of Appeals will hear arguments in El Comite Para El Bienestar De Earlimart v. EPA, a case challenging the U.S. Environmental Protection Agency’s (EPA) approval of provisions in a State Implementation Plan (SIP) adopted by California under the Clean Air Act (CAA) that regulate emissions of pesticides (primarily fumigants like methyl bromide) that potentially may contribute to possible exceedances of the National Ambient Air Quality Standard (NAAQS) for ozone. The El Comite case is the latest action in a series of challenges to California’s regulation of emissions of pesticides considered to be volatile organic compounds (VOC) stretching back to 2004. The case will consider substantive issues pertaining to the enforceability of the limits on pesticide VOC emissions in the SIP and the adequacy of those limits to attain compliance with the NAAQS. Of significant interest, it will also include a novel argument that EPA’s conclusion under CAA Section 7410(a)(2)(E) that the SIP did not violate Title VI of the Civil Rights Act is unsupported by the record.
The Plaintiffs will confront a stiff burden in litigating their Civil Rights claim. The Supreme Court has held that Title VI is violated only when actions have a discriminatory impact and such discrimination is intentional. EPA contends that California gave sufficient assurances that the pesticide controls in the SIP do not violate Title VI of the Civil Rights Act, and that it was reasonable for EPA to rely on those assurances when it approved the SIP. The Plaintiffs point to a preliminary finding made in 2011 by the EPA Office of Civil Rights (OCR) concerning the Angelina C. complaint, where OCR determined that emissions of methyl bromide during the years 1995-2001 had a disparate impact on Latino school children. This preliminary finding was later withdrawn following a settlement with California. The Plaintiffs say that given this history, EPA should have required California to provide a more detailed explanation of why its current regulation of pesticide emissions is not violative of Title VI. The Plaintiffs recently attempted to bolster their Title VI argument by asking the Court to take judicial notice of a report on pesticide use near schools issued by the California Environmental Health Tracking program in 2014, but EPA has opposed consideration of this report because it was not part of the administrative record when EPA approved the SIP revisions in 2012.
By Lisa R. Burchi
An ad hoc committee of the National Research Council (NRC) released a report, Review of California's Risk-Assessment Process for Pesticides, following its scientific and technical evaluation of the California Environmental Protection Agency’s (EPA) risk assessment process for pesticides.
The NRC committee review, which commenced in October 2013, examined documents provided by the California EPA’s Department of Pesticide Regulation (DPR) regarding the processes it uses for hazard identification, exposure assessment, dose-response analysis, and risk characterization. The Report discusses the following issues:
■ Setting Priorities Among Pesticides: The NRC committee generally supported DPR’s process under which pesticides are reviewed as candidates for risk assessment, but made recommendations for DPR to: (1) update and provide more details regarding its documentation of the priority setting process; (2) provide more explicit documentation and support for how pesticides are categorized into groups of high, medium, and low priority; and (3) develop a more objective and structured approach for ranking high-priority pesticides.
■ Risk Assessment Methods and Practices: The NRC committee reviewed DPR’s risk assessment guidance documents as well as three recently completed risk assessments for chloropicrin, carbaryl, and methyl iodide. The NRC committee found DPR’s documents to be comprehensive but questioned “whether the extensive effort needed to conduct a comprehensive risk assessment independently of EPA is justified in light of DPR’s resources.” The Committee recommended that DPR: (1) determine whether an independent and comprehensive evaluation of pesticides is required in every case where a risk assessment is performed; (2) incorporate problem formulation and other relevant elements recommended in the 2009 NRC report Science and Decisions: Advancing Risk Assessment into its risk assessment process; and (3) update its guidance documents “regularly and perhaps develop additional reference materials to reflect the most current risk-assessment practices.”
■ California Data to Inform Priority-Setting and Risk Assessment: The NRC committee found DPR’s practice of supplementing its exposure assessments with California-specific information to be “among the most valuable contribution to DPR’s risk-assessment process.” The committee suggests expanding DPR’s current Pesticide Use Reporting (PUR) program to include all licensed pesticide applicators and, if resources allow, “PUR data should be reviewed in relation to air-monitoring data and pesticide-illness surveillance data to determine whether any patterns are evident and to judge the accuracy of exposure assumptions or models.” The committee also had recommendations to improve the reporting of pesticide-related illnesses, including, for example, improving the training of physicians and searching electronic health records.