By Lisa M. Campbell and Lisa R. Burchi
On May 29, 2019, the California Department of Pesticide Regulation (DPR) released California Notice 2019-05: Changes to California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2019-05), which updates the guidance in California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2018-06).
Notice 2018-06, issued in January of 2018, provided to applicants for California registration of new agricultural use pesticides guidance specifically related to the requirement to submit at least one terrestrial field dissipation (TFD) study conducted under “California or similar environmental use conditions.” DPR states it is revising this guidance based on comments from the Western Plant Health Association. The updated guidance is summarized below.
Notice 2019-05 also extends the effective date to July 1, 2020; for applications submitted July 1, 2020, or later, DPR states it will consider a TFD study to have been conducted under “California or similar environmental use conditions” if the study was conducted within or outside of California in accordance with U.S. Environmental Protection Agency (EPA) study guidelines and under certain criteria, as provided below.
1. Timing: April 1 shall be the earliest study start date and September 30 shall be the latest start date. This timing ensures a potential leaching environment with respect to the amount of percolating water produced relative to evapotranspiration (ET).
- The study is conducted in a coarse-texture soil in accordance with the U.S. Department of Agriculture (USDA) soil textural classification (see Table 1). The minimum depth-weighted average sand content for representative samples taken across the test site should be no less than 68 percent as measured within the top 30 cm of soil. The allowable minimum soil sand content that is included in the average is 61 percent.
- The soils used for the study do not have a restrictive layer to the movement of water as indicated within the soil profile, such as a hardpan, compacted layer, or an abrupt change in texture.
- The maximum depth-weighted average organic matter content for representative samples taken across the test site should be no greater than 1.4 percent as measured within the top 30 cm of soil. The allowable maximum organic matter content that is included in the average is 1.6 percent.
- Studies shall be conducted on bare soil plots. Exceptions are possible for studies conducted in the presence of a crop or turf with sufficient justification.
3. Water Inputs:
- Water applications to the study site are sufficient to create levels of percolating water that reflect the potential amount lost from crop irrigations (i.e., 160 percent of ET). Approximately 60 percent of applied water is available for movement below the coring depth, which would equate to water applications of approximately 160 percent of ET. Therefore, a scheduled water input would approximate the cumulative daily ET since the previous water input multiplied by an excess demand factor of 1.6. For bare soil plots, ET can represent reference ET or, if preferred, soil evaporation when calculated using a scientifically defensible methodology. These water inputs supersede those in EPA’s guidance document for TFD studies.
- The initial water application to the study site occurs within one week of chemical application. Subsequent water applications shall be at seven-day intervals or less for the duration of the study.
- Water inputs from rain are subtracted from scheduled water input amounts.
DPR states that if a TFD study submitted to DPR to meet the statutory requirement of having been conducted under “California or similar environmental use conditions” does not meet one or more of the above criteria, the applicant may include in its submission a justification for any different criteria to avoid a determination that the study is unacceptable.
Table 1. USDA textural classes1 of soils acceptable for TFD studies
1Based on USDA particle-size classification.
By Lisa M. Campbell and Lisa R. Burchi
On May 28, 2019, the California Department of Pesticide Regulation (DPR) posted a new presentation identifying the top ten agricultural pesticide use violations of 2018. Its announcement states that “DPR suggests reviewing these common violations of pesticide laws and regulations to help ensure … compliance.” The presentation, “Top 10 Agricultural Pesticide Use Violations of 2018,” is available here. The violations are listed from the least common (number 10) to the most common (number 1):
10. Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724. Examples of handler training violations listed in the presentation are: not updating employee training before a new pesticide is handled; and not providing employees handler training before they work on or repair equipment previously used to apply pesticides.
9. Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1. Examples of violations listed in the presentation are: not including a specific description of the location of the ASI on the Pesticide Safety Information Series (PSIS) A-9 leaflet so that workers have unimpeded access; and not displaying the ASI before fieldworkers work in a treated field.
8. Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761. Examples of these types of violations listed in the presentation are: not retaining Safety Data Sheets (SDS) for the pesticides listed in the pesticide use records within the past two years; and not informing employees or the Farm Labor Contractor (FLC) of the location of the pesticide use records before the employees enter a treated field.
7. Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734. Examples of these types of violations listed in the presentation are: not having an emergency eye flush station able to rinse the eye gently for 15 minutes at the mix and load site, when protective eyewear is required by the pesticide labeling; and handlers using hand sanitizer for decontamination instead of soap and water.
6. Availability of Labeling, regulated under 3 C.C.R. § 6602. Examples of labeling availability violations listed in the presentation are: not having relevant Special Local Needs (SLN) labeling at the site when mixing, loading, or applying; and not having the labeling booklets on-site when mixing, loading, or applying.
5. Service Container Labeling, regulated under 3 C.C.R. § 6678. Examples of service container labeling violations listed in the presentation are: not including the signal word on a service container label; and not including the address of the company or person responsible for the container on the label.
4. Annual Registration with County Agricultural Commissioner by Anyone Who Intends to Advertise, Solicit, or Operate as a Pest Control Business in California, regulated under California Food and Agriculture Code (FAC) § 11732. An example of a violation is performing pest control activities in a county before registering with the County Agricultural Commissioner (CAC).
3. Emergency Medical Care Requirements, regulated under 3 C.C.R. § 6726. Examples of violations listed in the presentation are: not taking employees suspected of a pesticide illness to the doctor immediately; and failure to post the handler emergency medical care information.
2. Personal Protective Equipment (PPE) Requirements, regulated under 3 C.C.R. § 6738. Examples of violations listed in the presentation are: storing PPE in the same place pesticides are stored; and an employer not providing the proper PPE required by the labeling.
1. Labeling and Permit Conditions Compliance, regulated under FAC § 12973. Examples of violations listed in the presentation are: not following the pesticide storage requirements listed on the labeling; and applying a pesticide to a site or crop not listed on the labeling.
Additionally, DPR has created an informative presentation about the 2019 license renewal process to help spread awareness to those renewing this year (last names and business names starting with M-Z). DPR states that it encourages continuing education (CE) sponsors, CAC staff, and others to use the presentation to inform license and certificate holders renewing this year about DPR’s renewal process, CE requirements, important dates, and the benefits of renewing early. The 2019 Renewal Process presentation is available here.
By Lisa M. Campbell and Lisa R. Burchi
On May 8, 2019, the California Environmental Protection Agency (CalEPA) announced that the California Department of Pesticide Regulation (DPR) will be initiating cancellation proceedings of chlorpyrifos. In its press release, CalEPA states that the decision to commence cancellation proceedings “follows mounting evidence, including recent findings by the state’s independent Scientific Review Panel on Toxic Air Contaminants, that the pesticide causes serious health effects in children and other sensitive populations at lower levels of exposure than previously understood.”
DPR’s decision, following years of review in California of chlorpyrifos, is sure to garner significant controversy, comments, and, potentially, litigation.
Chlorpyrifos first entered the comprehensive risk assessment process after being designated by DPR with a “high” priority status in 2011, and some of the DPR documents supporting the current action were issued in 2011.
In December 2015, DPR released a draft risk assessment for public comment. Since the risk assessment identified potential human exposure to spray drift (via inhalation or deposition) as a concern, DPR entered chlorpyrifos in its formal evaluation process to determine the scientific evidence for listing it as a pesticide Toxic Air Contaminant (TAC) (CA Food & Agric. Code §§ 14021-14027).
DPR’s assessments were intended to evaluate chlorpyrifos as a pesticide TAC as defined in California regulations (Title 3, Section 6864). The determination of a pesticide TAC is based on whether the air concentrations, either measured or modeled, exceed the reference concentration (RfC) divided by ten. Under the applicable California statutory provisions, designation of an active ingredient as a TAC is based on an evaluation that assesses the following:
- The availability and quality of data on health effects;
- The potency, mode of action, and other relevant biological factors;
- An estimate of the levels of exposure that may cause or contribute to adverse health effects; and
- The range of risks to humans resulting from current or anticipated exposure (CA Food & Agric. Code § 14023(a)).
DPR published its draft revised report entitled "Evaluation of Chlorpyrifos as a Toxic Air Contaminant" in December 2017 and an addendum to that report in June 2018. DPR issued its final TAC evaluation in July 2018. The July 2018 evaluation concludes that “chlorpyrifos meets the criteria of TAC designation by using either the developmental neurotoxicity endpoint or the [acetylcholinesterase (AChE)] inhibition endpoint, even without the additional 10x uncertainty factor necessary to account for the fact that the developmental neurotoxicity effects occur at a lower level than AChE inhibition.”
DPR’s findings, public comments, and responses to those comments were reviewed by the Scientific Review Panel (SRP) on TACs. SRP’s findings on chlorpyrifos issued in August 2018 “unanimously concluded that the report, with the revisions requested by the Panel, is based on sound scientific knowledge, and represents a balanced assessment of our current scientific understanding.”
In April 2019, chlorpyrifos was listed in California as a TAC, which triggered a DPR requirement to “develop control measures to protect the health of farm workers and others living and working near where the pesticide is used.” In its press release announcing the cancellation proceedings, CalEPA states that “DPR has determined, in consultation with CDFA, the Office of Environmental Health Hazard Assessment (OEHHA), and the California Air Resources Board (CARB), that sufficient additional control measures are not feasible.”
DPR’s announcement is the beginning of what DPR estimates could be a two-year cancellation proceeding, although in reality the process may take even longer. Other actions proposed in conjunction with the cancellation proceeding include:
- DPR to consult with county agricultural commissioners and local air pollution control districts before filing for cancellation.
- DPR to support “aggressive” enforcement of existing restrictions on the use of chlorpyrifos, including a ban on aerial spraying, quarter-mile buffer zones, and limiting use to crop-pest combinations that lack alternatives.
- DPR and CDFA to convene a cross-sector working group to identify, evaluate, and recommend safer and more practical and sustainable alternative pest management solutions to chlorpyrifos.
- California Governor Gavin Newsom to propose $5.7 million in new budget funding “to support the transition to safer, more sustainable alternatives.
DPR’s action must also be viewed in conjunction with various federal and state reviews and resulting litigation regarding chlorpyrifos’ continued registration and use. The U.S. Environmental Protection Agency (EPA) for example, is conducting its own registration review of chlorpyrifos, and was ordered by the U.S. Court of Appeals for the Ninth Circuit to issue, within 90 days of the April 19, 2019, order, its final decision regarding the continued registration of chlorpyrifos.
Other states are also taking action to ban chlorpyrifos, notably Hawaii, which enacted legislation in 2018 to ban the use of chlorpyrifos in Hawaii by 2022; and New York, whose legislature approved bills in April 2019 to ban chlorpyrifos use in New York by 2021.
Stakeholders should review all these issues closely, as these unprecedented decisions are likely to provide multiple opportunities to comment or otherwise participate to ensure that regulatory requirements are indeed being met for cancellation.
More information concerning chlorpyrifos is available on our blog.
By Lisa M. Campbell and Lisa R. Burchi
On December 28, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-26 changing its Notice of Decision (NOD) and public report documentation for proposed registration decisions to ensure continued compliance with its certified regulatory program obligations under the California Environmental Quality Act (CEQA). The new changes to the NODs and public report documentation will be effective May 1, 2019.
These changes are as a result of a 2014 lawsuit brought by Pesticide Action Network North America (PANNA), et al. challenging DPR’s acceptance of label amendments for two previously registered dinotefuran pesticide products. The First District Court of Appeal held that DPR’s NODs and public reports supporting the dinoteferan registration actions were deficient because DPR could not demonstrate that it properly considered certain factors specified in CEQA. In essence, the court concluded that certain CEQA requirements that DPR construed as procedural in nature were actually substantive standards that DPR must meet and adequately document in its administrative record. Specifically, the court found that DPR failed to include a checklist or other documentation with meaningful analysis explaining how DPR reached its conclusion that the approval of the proposed label changes would not cause a significant adverse impact to human health, flora, fauna, water, and air.” The court also found DPR’s discussion of alternatives and cumulative impacts inadequate. Information about that case is available in our blog item California Court of Appeal Reverses Trial Court Decision Denying PANNA’s Petition Challenging Approval by DPR of Pesticides Containing Dinotefuran.
CEQA is intended to ensure projects permitted by public agencies consider the long-term protection of the environment. DPR states that CEQA “requires state and local agencies to develop an environmental impact report (EIR) for any proposed or approved project that may have a significant effect on the environment (including human health) or a negative declaration if there is substantial evidence of no significant impacts.” EIRs provide public agencies and the public “with detailed information about a proposed project’s significant effects on the environment, describe ways these effects can be minimized, and indicate alternatives to the proposed project.” CEQA and its implementing regulations set forth in Title 3, California Code of Regulations (3 Cal. Code Regs.) Sections 6254 and 6255, also require DPR to issue a weekly Notice of Proposed Decisions to Register Pesticide Products and Public Report, listing each proposed decision to register and amend pesticide products for a 30-day public comment period.
Changes to the NOD and Public Report Documentation
To address concerns raised by the court and to protect its certified program status, on January 3, 2018, DPR issued California Notice 2018-01 (“Expanding Use of Pesticide Products Under Reevaluation”), providing that, effectively immediately, DPR “will not act upon an Application for Pesticide Registration or Application to Amend Pesticide Product if DPR 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.”
With Notice 2018-26, DPR will change the documentation associated with its environmental analysis in the NODs and public reports. According to Notice 2018-26, the revised NODs and public reports will address the following areas for each pesticide product noticed for registration:
- Discussion of DPR’s certified program under CEQA;
- Relevant DPR regulations for the proposed decision and public report;
- Detailed description of the project;
- Overview of the registration program, scientific evaluation process, and continuous evaluation;
- Environmental and human health factors examined (i.e., checklist containing the following CEQA areas: human health, flora, fauna, water, and air);
- Discussion of feasible alternatives and mitigation;
- Discussion of existing environmental conditions and cumulative impacts; and
- Conclusion explaining DPR’s analysis of potential significant adverse impacts to human health, flora, fauna, water, and air.
In addition, each public report will include the proposed label. For label amendments, DPR will include both the proposed label and currently accepted label.
In summary, effective May 1, 2019, DPR “will no longer post new products and label amendments exiting the formal evaluation process as proposed to register for the 30-day public comment period until DPR completes a public report explaining why the new product or label amendment is not reasonably expected to cause a significant adverse impact to human health, flora, fauna, water, and air.” New products and label amendments that exit the formal evaluation process prior to May 1, 2019, will be posted for the 30-day public comment period using the current NOD documentation.
The impact of these changes could be substantial from a timing and DPR workload perspective and, thus, of significant concern to registrants. DPR has stated it is reviewing its internal processes and procedures and hiring additional staff to accommodate changes in workload as a result of the NOD and public report documentation changes. This is based, in part, on the fact that if current evaluation reports are not available for each CEQA checklist area (i.e., human health, flora, fauna, water, and air), DPR staff may need to review prior evaluation reports, documentation in product files, U.S. Environmental Protection Agency (EPA) risk assessments, and other available information to develop the public report. Moreover, DPR states that if it does not have adequate information to address each CEQA checklist area, the product may need to reenter DPR’s formal evaluation process. All of these factors could significantly extend the amount of time DPR takes to review a new product or amendment, as it must now develop these public reports prior to proposing registration decisions with a 30-day public comment period, and that time could be even longer in cases where DPR determines it requires additional evaluation of the product and/or data necessary to complete such public reports.
By Timothy D. Backstrom and Lisa M. Campbell
On September 19, 2018, the California Department of Pesticide Regulation (DPR) proposed a regulation to designate chlorpyrifos as a toxic air contaminant (TAC). DPR states that this proposal is being presented “after an extensive period of scientific and public review.” The proposed rule is based on a final evaluation issued in July 2018, in which DPR’s Human Health Assessment (HHA) Branch determined that chlorpyrifos meets the quantitative criteria for designation as a TAC. To make that determination, DPR utilized an inhalation reference concentration (RfC) based on new animal studies with chlorpyrifos that reported neurodevelopmental effects at exposure levels well below the threshold for acetylcholinesterase (AChE) inhibition. More information on DPR’s final TAC evaluation is available in our blog item "California DPR Releases Final Toxic Air Contaminant Evaluation for Chlorpyrifos." In August 2018, DPR posted the Scientific Review Panel on TAC’s findings on chlorpyrifos and the Director’s Proposed Determination Concerning Chlorpyrifos as a TAC.
The U.S. Environmental Protection Agency (EPA) previously issued a determination that the default 10X safety factor for infants and children established by the Food Quality Protection Act (FQPA) should be retained for chlorpyrifos. This determination was based primarily on epidemiology studies that purported to show adverse neurodevelopmental outcomes in humans at exposure levels below the threshold for AChE inhibition, but the methodology used in these epidemiology studies has been harshly criticized by the pesticide industry. In contrast, the DPR TAC proposal is predicated on a determination that new animal studies with chlorpyrifos report neurodevelopmental effects below the threshold for AChE inhibition, and DPR views the epidemiology studies utilized by EPA to make its FQPA determination as providing corroboration for the animal data. At this juncture, it is not clear how EPA will characterize the new animal data concerning chlorpyrifos. In any case, questions are likely to remain concerning EPA’s use of data concerning chorpyrifos to establish the FQPA safety factor for other organophosphate (OP) pesticides.
More information on chlorpyrifos issues and California DPR regulations is available on our blog.
By Lisa M. Campbell and Timothy D. Backstrom
In July 2018, the California Environmental Protection Agency’s Department of Pesticide Regulation (DPR), Human Health Assessment (HHA) Branch, issued its final toxic air contaminant (TAC) evaluation of chlorpyrifos. This final TAC evaluation updates the December 2017 draft evaluation of chlorpyrifos as a TAC for the Scientific Review Panel (SRP) which updated the August 2017 draft and was reviewed by the SRP on TACs, and incorporates certain changes based on SRP recommendations. As part of their review of the December 2017 draft, the SRP recommended “additional and detailed review of developmental neurotoxicity studies, in particular recent in vivo animal studies as well as a more in depth analysis of human effects of chlorpyrifos” and “that DPR reevaluate the critical endpoints, the associated [(uncertainty factors (UF)], and the resulting [reference concentrations (RfC)] and [reference doses (RfD)] for each endpoint.”
DPR determines that a pesticide is a TAC for a non-cancer adverse effect if the projected air concentrations associated with use of the pesticide are more than one tenth of the inhalation RfC established based on animal toxicity and epidemiology data. In the draft TAC evaluation for chlorpyrifos, DPR utilized the threshold for red blood cell acetylcholinesterase (AChE) inhibition in humans and a target margin of exposure (MOE) of 100, including a factor of 10 intended to account for potential neurodevelopmental effects below the threshold for RBC AChE inhibition. In the final TAC evaluation for chlorpyrifos, DPR increased the MOE for AChE inhibition to 300, based on deficiencies in the human inhalation parameters used to model the threshold for AChE inhibition.
In addition, the final TAC evaluation establishes a new No Observed Effect Level (NOEL) for neurodevelopmental effects in animal studies with chlorpyrifos reported at exposure levels well below the threshold for AChE inhibition. Based on this NOEL, DPR has derived a new inhalation RfC for neurodevelopmental effects, using a standard MOE of 100 consisting of 10X for interspecies sensitivity and 10X for intraspecies variability. This new inhalation RfC based on neurodevelopmental effects in animal studies is about one-half the revised inhalation RfC based on the threshold for AChE inhibition. Because the modeled spray drift air concentrations for chlorpyrifos are more than one tenth of this new inhalation RfC, DPR concludes “that chlorpyrifos meets the criteria to be listed as a TAC pursuant to the law of California.”
In the final TAC evaluation for chlorpyrifos, DPR concluded that there is sufficient evidence from animal studies to establish a new NOEL for neurodevelopmental effects, which is well below the level that has been shown to cause AChE inhibition in the same animals. Although the U.S. Environmental Protection Agency (EPA) has previously issued a determination that the default 10X safety factor for infants and children established by the Food Quality Protection Act (FQPA) should be retained for chlorpyrifos, this determination was based on epidemiology studies that purported to show adverse neurodevelopmental outcomes in humans at exposure levels below the threshold for AChE inhibition. The methodology used in these epidemiology studies has been harshly criticized by the pesticide industry. DPR views these epidemiology studies as providing corroboration, but the new DPR risk assessment is predicated instead on DPR’s view that animal studies with chlorpyrifos report neurodevelopmental effects below the threshold for AChE inhibition. The DPR risk assessment based on these animal studies uses a standard MOE of 100. How EPA may or may not view DPR’s conclusion is not known. In light of the August 9, 2018, decision by the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) directing EPA to proceed with revocation of all tolerances and cancellation of all registrations for chlorpyrifos, the effect of the DPR conclusion on EPA actions is not clear. Nevertheless, it is worth noting that, because the mechanism by which chlorpyrifos would cause such neurodevelopmental effects is unknown and is below the level that causes AChE inhibition, any presumption by EPA that other organophosphate (OP) pesticides may cause the same type of effects will likely be vigorously disputed by industry on scientific grounds.
Please see our blog item Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos for more information on the Ninth Circuit’s August 9, 2018, decision.
By Lisa M. Campbell and Margaret R. Graham
On April 23, 2018, the California Department of Pesticide Regulation (DPR) circulated a presentation entitled “Top 10 Agricultural Pesticide Use Violations of 2017” that identifies the top ten agricultural most common pesticide use violations of 2017 in California. The violations are listed from the least common (#10) to the most common (#1):
10. Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724(b-e). Examples of handler training violations listed in the presentation are: not updating employee training on a new pesticide handled; and not training employees prior to them mixing, loading, or applying pesticides.
9. Availability of Labeling, regulated under 3 C.C.R. § 6602. Examples of labeling availability violations listed in the presentation are: not having relevant Special Local Needs (SLN) labeling at the site when mixing, loading, or applying; and not having the labeling booklet on-site when mixing, loading, or applying.
8. Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734. Examples of these types of violations listed in the presentation are: a handler using a backpack sprayer and not carrying a pint of eyewash when the label requires eye protection; and handlers using hand sanitizer instead of soap and water.
7. Service Container Labeling, regulated under 3 C.C.R. § 6678. Examples of service container labeling violations listed in the presentation are: not including the signal word on a service container label; and only putting the name of the pesticide on the service container.
6. Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761. Examples of these types of violations listed in the presentation are: not completing the required fields on the displayed Pesticide Safety Information Series (PSIS) A-9 leaflet; and not providing Safety Data Sheets (SDS) for the pesticides listed on the pesticide use records.
5. Annual Registration with County Agricultural Commissioner by Anyone Who Intends to Advertise, Solicit, or Operate as a Pest Control Business in California, regulated under California Food and Agriculture Code (FAC) § 11732. An example of a violation is not registering with the county in which such a business intends to work prior to performing pest control activities.
4. Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1. Examples of violations listed in the presentation are: not including the start and stop times, Restricted Entry Interval (REI), or active ingredient in the displayed information; and not displaying the ASI before fieldworkers work in a treated field.
3. Emergency Medical Care Requirements, regulated under 3 C.C.R. § 6726. Examples of violations listed in the presentation are: not taking employees suspected of a pesticide illness to the doctor immediately; and not posting the name, address, and phone number of the medical facility at the worksite or in the work vehicle before employees begin handling pesticides.
2. Personal Protective Equipment (PPE) Requirements, regulated under 3 C.C.R. § 6738. Examples of violations listed in the presentation are: storing PPE in the same place pesticides are stored; and not cleaning PPE and checking for wear after each use.
1. Labeling and Permit Condition Compliance, regulated under FAC § 12973. Examples of violations listed in the presentation are: not following label-required buffer zone, set back distance, or vegetative buffer strip requirements; and applying a pesticide to a site or crop not listed on the labeling.
DPR states that it “recommends and encourages continuing education (CE) course sponsors [to] integrate this information into … future CE courses,” and asks for help “in promoting lawful pesticide use practices by encouraging [CE] attendees to review these agricultural pesticide use violations as they relate to their operations, to assure they are in compliance with federal and California pesticide use requirements.”
By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham
On February 22, 2018, the Superior Court of the State of California, County of Sacramento, issued a judgment granting petition for writ of mandate and declaratory and injunctive relief (Judgment) to suspend further chemical activities undertaken by the California Department of Food and Agriculture (CDFA) to control or eradicate pests under the Statewide Plant Pest Prevention and Management Program (the Project) until CDFA has certified a Program Environmental Impact Report (PEIR) that corrects violations of the California Environmental Quality Act (CEQA) identified in the court’s ruling.
CDFA is charged with promoting and protecting the state’s agricultural industry, and preventing the introduction and spread of injurious insect or animal pests, plant diseases, and noxious weeds. Cal. Food & Agr. Code §§ 4011 401.51 403. CDFA developed the Project to control targeted pests or pathogens, and includes activities such as pest rating (evaluation of a pest’s environmental, agricultural, and biological significance); identification, detection, and delimitation of new pest populations; pest management response (which may include eradication and/or control of new or existing pest populations); and prevention of the movement of pests into and within California.
The present case was brought after CDFA sought to comply with CEQA by preparing a single PEIR that provides a consolidated set of management practices rather than prepare Environmental Impact Reports (EIR) specific to particular pest management activities. Petitioners alleged that CDFA violated CEQA by certifying the PEIR for the Project and in related proceedings that CDFA violated CEQA by subsequently expanding the Statewide Plant Pest Prevention and Management Program to allow increased use of certain pesticides (Merit 2F and Acelepyrn) for the treatment of Japanese beetles without adequate environmental review.
The numerous CEQA violations identified by the court are set forth in a Consolidated Ruling on Submitted Matters (Consolidated Ruling) issued January 8, 2018, and attached as Exhibit 1 to the Judgment. The Consolidated Ruling discusses the following topics:
- Does the PEIR’s tiering strategy violate CEQA?
- Does CEQA require the Department to issue a Notice of Determination (NOD) anytime is carries out or approves a site-specific activity?
- Does the PEIR contain an adequate project description?
- Does the PEIR contain an adequate description of the baseline environmental setting?
- Does the PEIR fail to adequately analyze environmental impacts?
- Does the PEIR fail to adequately analyze the Project’s cumulative impacts?
- Does the PEIR improperly defer mitigation measures or conceal them as Program Features?
- Does the PEIR fail to adequately consider a range of reasonable alternatives to the Project?
- Did the Department violate CEQA’s notice and consultation requirements?
- Did the Department adequately respond to public comments on the DRAFT PEIR?
- Did the Department properly use addenda to modify the PEIR?
The court found multiple, broad-based issues with the PEIR, including, for example, a decision that the PEIR violates CEQA “because it adopts an unlawful tiering strategy, granting the Department authority to implement a broad range of practices without evaluating the site-specific conditions to determine whether the environmental impacts were covered in the PEIR.” The Consolidated Ruling also discusses particular failures of the PEIR. Additionally, of potential interest is the court’s opinion with regard to whether the PEIR failed to disclose and analyze impacts on sensitive biological resources, which Petitioners argued was based on several grounds: (i) an assumption that spraying “generally” will not occur near sensitive resources and fails to analyze potential impacts from pesticide drift; (ii) a conclusion, without substantial evidence, that the Project will have less-than-significant impacts on sensitive species; (iii) a conclusion, without substantial evidence, that traps and lures will not have significant impacts on non-target species; (iv) the use of improper thresholds of significance for impacts to pollinators and organic farming; and (v) a failure to define, disclose, and analyze impacts on wetlands.
The court did not find issues with the PEIR as it related to CDFA’s spraying assumptions and CDFA’s determinations of potential impacts on sensitive species, pesticide drift, or organic farming. The court likewise rejected Petitioner’s other challenges to the PEIR’s analysis of biological impacts, including the PEIR's analysis of traps/lures and of the species evaluated in the Ecological Risk Assessment (ERA).
The court did, however, agree with Petitioners that the PEIR improperly ignored potentially significant impacts to pollinators. The court stated that the PEIR considered impacts to pollinators significant only if (1) the pollinator species impacted were “special status,” or (2) the impacts would result in a secondary change in the physical environment (such as conversion of land from agricultural to non-agricultural use). The PEIR did not consider whether the Project might adversely impact non-special-status pollinators, despite acknowledging that “healthy pollinator populations are critical to protecting the environmental quality and agricultural resources of the state,” and that “Colony Collapse Disorder” and “pollinator decline” are “ongoing ... serious” problems. The court found that CDFA’s “‘voluntary’ actions to benefit pollinator species are not, by themselves, sufficient to justify the lack of analysis and enforceable mitigation measures for the potentially significant impacts to non-special-status pollinators.”
The immediate effect of this decision is the inability for CDFA to continue “chemical activities … to control or eradicate pests under the [Statewide Plant Pest Prevention and Management] Program except as authorized under CEQA independent of the PEIR.” Should this decision stand, registrants and stakeholders should be interested in whether and how CDFA modifies the PEIR to support its pest control and management activities.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On February 26, 2018, the U.S. District Court for the Eastern District Court of California issued a memorandum and order on the plaintiff’s motion for preliminary injunction (Order) to “enjoin the listing of glyphosate under Proposition 65 (Prop 65) and the application of its attendant warning requirement pending a final judgment in this case and set a schedule for expedited final resolution of the case.” The Order (1) grants plaintiffs’ request for a preliminary injunction enjoining the warning requirement of California Health & Safety Code § 25249.6 as to glyphosate; and (2) denies the request for a preliminary injunction enjoining defendants from listing glyphosate as a chemical known to the State of California to cause cancer under California Health & Safety Code § 25249.8. Specifically, the Order states: “pending final resolution of this action, defendants … are hereby ENJOINED from enforcing as against plaintiffs … California Health & Safety Code § 25249.6’s requirement that any person in the course of doing business provide a clear and reasonable warning before exposing any individual to glyphosate.” Although this is only a preliminary injunction while the case continues further resolution, it is extremely significant that, for now, glyphosate will continue to be listed on California’s Prop 65 list as a “chemical known to the State of California to cause cancer,” but products containing glyphosate will not be required to comply with the warning requirement.
Plaintiffs’ memorandum supporting its motion for preliminary injunction states that Prop 65’s requirement for products containing glyphosate to include a warning that glyphosate is “known to the State of California to cause cancer” is unconstitutional under the First Amendment, and, if allowed to go into effect, will cause Plaintiffs’ “reputational, competitive, and economic harms for which they cannot be compensated.” Plaintiffs state that the “legal merit of their First Amendment claim is indisputable and obvious on the face of the attached documents without any need for discovery, and thus the claim is appropriate for expedited judicial resolution.” California’s Office of Environmental Health Hazard Assessment (OEHHA), the agency responsible for implementing Prop 65, listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017, and the attendant warning requirement would have taken effect on July 7, 2018.
In support of denying the request for a preliminary injunction enjoining defendants from listing glyphosate under Prop 65, the court states that plaintiffs “have not shown a likelihood of success on the merits of their claim that the listing of glyphosate violates the First Amendment, because the listing is government speech, not private speech … [and it] is only the upcoming July 2018 deadline for providing the [Prop 65] warning that compels private speech.” The court noted further that Plaintiffs “have not shown a likelihood of irreparable harm should the court fail to enjoin the listing of glyphosate, because any harm that plaintiffs might suffer is caused by the warning requirements of [Prop 65], rather than the listing itself.” Accordingly, the court denied a preliminary injunction based on plaintiffs’ claim that the glyphosate listing violates the First Amendment.
On the other hand, in support of granting the request for a preliminary injunction enjoining the application of the attendant warning requirement, the court stated:
- On the evidence before the court, the required warning for glyphosate does not appear to be factually accurate and uncontroversial because it conveys the message that glyphosate’s carcinogenicity is an undisputed fact, when almost all other regulators have concluded that there is insufficient evidence that glyphosate causes cancer.
The court also stated that the required warnings are “false and misleading” and that plaintiffs “have shown that they are likely to succeed on the merits of their First Amendment claim, are likely to suffer irreparable harm absent an injunction, and that the balance of equities and public interest favor an injunction, the court will grant plaintiffs’ request to enjoin [Prop 65]’s warning requirement for glyphosate.”
This case, while not the end of the story, is a very significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally. Industry should follow this case closely given the implications for glyphosate and potentially other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-regulated pesticides and chemicals generally. Some in industry have long been concerned that Prop 65 warning requirements contradict conclusions supported by the data and reached by other agencies such as the U.S. Environmental Protection Agency (EPA). This decision is a huge preliminary win for those with these concerns and, depending on the ultimate outcome of the case, could provide a precedent for additional challenges related to other substances. The potential reach of the case beyond glyphosate, however, will likely be dictated heavily by the facts of each case.
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.