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 Lisa R. Burchi
On April 23, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced it is proposing to amend Article 6 of Title 27 of the California Code of Regulations (C.C.R.), Section 25603, specifically the safe harbor warning content for on product warnings for exposures to listed chemicals in pesticides. OEHHA states that this regulation is “intended to provide compliance assistance for businesses that cause pesticide exposures in order to reduce the potential for litigation concerning the sufficiency of warnings, while still allowing them to comply with other federal and state requirements for warnings provided on a label.” It is a part of the new Article 6 Clear and Reasonable Warnings regulations, which OEHHA adopted in August 2016 and which become effective on August 30, 2018. These new regulations include safe harbor warning methods and content for consumer product exposures (Sections 25602 and 25603) and occupational exposures (Section 25606) to listed chemicals. The Initial Statement of Reasons (ISOR) is available here and the proposed regulatory text is available here. The ISOR summarizes the proposed rulemaking:
- This proposed rulemaking would add a new subsection (d) to Section 25603, addressing safe harbor warning content for on product labels for consumer product and occupational exposures to listed chemicals from the use of pesticides where those labels are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related California laws and regulations.
- This new subsection would further the “right-to-know” purposes of the statute and clarify the content of safe harbor warnings for exposures that can occur from the use of pesticide products, where those warnings are provided on a label that is regulated under FIFRA and certain California laws.
The issue that OEHHA intends this proposal to address stems from the fact that OEHHA’s revised warning requirements require the signal word “WARNING” but the U.S. Environmental Protection Agency (EPA) “historically has not approved labels containing the terms ‘caution,’ ‘warning,’ or ‘danger,’ unless the word is the same as the [EPA]-required signal word for that label.” Thus, OEHHA is proposing the following regulatory exception from the “WARNING” requirement:
- Notwithstanding subsection (a)(2) or (b)(2) [setting forth the content of consumer product exposure warnings], where a warning for a consumer product exposure or occupational exposure from use of a pesticide is provided on a product label, and the pesticide label is regulated by the United States Environmental Protection Agency under the Federal Insecticide, Fungicide, and Rodenticide Act, Title 40 Code of Federal Regulations, Part 156; and by the California Department of Pesticide Regulation under Food and Agricultural Code section 14005, and Cal. Code of Regs., title 3, section 6242; the word “ATTENTION” or “NOTICE” in capital letters and bold type may be substituted for the word “WARNING.”
OEHHA states this is intended to be a “narrow exception” and that it is only intended to apply where EPA and California Department of Pesticide Regulation (CDPR) signal words and the Proposition 65 (Prop 65) signal word conflict. This proposal is intended to address the concerns of pesticide registrants encountering problems when they attempted to amend their EPA-approved labels to include the Prop 65 “WARNING” signal word. It remains unclear, however, whether the OEHHA proposal will fully address EPA’s concerns, and what effect it will have on EPA’s ability to approve labels that contain the language at issue. Registrants should review the proposal carefully and monitor closely EPA’s actions concerning it and this issue more generally.
Comments are due by June 11, 2018, and can be submitted to OEHHA via its website. OEHHA states that any requests for a public hearing on this proposed regulatory amendment should be submitted by May 25, 2018.
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.
By Lisa M. Campbell and Heather F. Collins, M.S.
On Friday, November 3, 2017, the California Department of Pesticide Regulation (DPR) issued guidance (California Notice 2017-13) that DPR indicates is intended to align DPR policy with the U.S. Environmental Protection Agency’s (EPA) guidance on secondary container labeling for pesticides. DPR’s guidance states that secondary containers are used by the pesticide industry as part of the process of applying pesticides and “cannot be sold or distributed.” The guidance further notes that secondary containers are “most commonly used in institutional settings for concentrated antimicrobials that are diluted prior to use or to hold pesticides filled from a larger container to be used and stored prior to application.”
Registrants may elect to provide users with labels for secondary containers. DPR’s new guidance states: “Secondary container labels are not required to be submitted to U.S. EPA or DPR.” Under the new DPR policy, however, effective immediately, if a registrant submits a secondary container label to DPR, “it must bear the same signal word as the concentrate label or no signal word.” DPR states that it will accept a secondary container label with a lesser signal word, precautionary statements, and alternate directions for use for the diluted product only if acute toxicity data are submitted or are currently on file to support these lesser statements.
DPR’s new guidance also incorporates EPA guidance on what a secondary label should contain. (EPA does not require secondary containers to be labeled, but notes that the applicator remains responsible for following the requirements on the pesticide product’s labeling, and complying with other relevant requirements in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes.) Although registrants are not required to submit secondary container labels to EPA for review, EPA recommends that the applicator identify the material in the secondary container in the event of a spill to ensure that adequate information regarding the pesticide can be obtained in case of a medical or environmental emergency. EPA recommends that such labels include the following information:
- Product name;
- EPA registration number;
- Name and percentage of active ingredient of the concentrated product or if known, the percentage of active ingredient in the end-use dilution;
- If the product in the secondary container is diluted, it should be followed by the phrase: “The product in this container is diluted as directed on the pesticide product label”;
- The same signal word as the registered concentrate container label;
- The same precautionary statements as the registered concentrate container label unless the registrant has acute toxicity data supporting lesser precautionary statements for the diluted product and alternate directions for the diluted product are indicated on the concentrate container label; and
- The statement: “Follow the directions for use on the pesticide label when applying this product.”
DPR states: “If currently registered products have secondary container labels on file with DPR that do not meet the above criteria, registrants should submit revised labels to DPR as an amendment.”
Each submission must include:
- California Application to Amend Pesticide Product (DPR-REG-035);
- $25 application fee (payable to: Cashier, Department of Pesticide Regulation);
- A copy of the most current EPA stamp-accepted label;
- Six copies of the concentrate container label; and
- Six copies of the secondary container label.
- If the precautionary statement on the secondary container label bears lesser precautionary statements, the submission must be accompanied by acute toxicity data or a reference to data on file with DPR.
As an alternative to submitting revised labels, registrants have the option of requesting that DPR rescind acceptance of the current stamp-accepted secondary container label previously submitted. Registrants may submit their request in writing on company letterhead to their assigned Regulatory Scientist. If a secondary container label is inconsistent with the DPR-approved label, DPR will consider the product misbranded, and DPR notes that misbranded products are subject to enforcement action.
Registrants that have previously submitted secondary labels to DPR should review the label in comparison to the DPR-approved concentrate container label and the requirements in this notice. All inconsistencies must be corrected via amendment submission to DPR or by making a request that DPR rescind acceptance of the current stamp-accepted secondary label so that the product is not considered misbranded and therefore subject to enforcement action.
By Lisa M. Campbell and Timothy D. Backstrom
On September 19, 2017, California’s Court of Appeal for the First Appellate District reversed a trial court decision denying a petition by the Pesticide Action Network North America (PANNA) challenging the approval by the California Department of Pesticide Regulation (DPR) of amended labeling for two previously registered pesticides containing the active ingredient dinotefuran, a neonicotinoid: Dinotefuran 20SG, manufactured by Mistui Chemicals Agro, Inc.; and Venom Insecticide, manufactured by Valent U.S.A. Corporation. PANNA’s petition alleged that DPR “violated the California Environmental Quality Act (CEQA) by approving the label amendments without sufficient environmental review.” The amended labeling for these two neonicotinoid products added some new registered uses and also increased the allowable application rates for certain existing uses.
The court’s construction of CEQA was a critical element in its decision. Since the DPR regulatory program has been certified pursuant to CEQA, the court agreed that DPR can utilize its standard program documents for pesticide registration actions in lieu of the documents typically prepared under CEQA. The court disagreed, however, with DPR’s assertion that “its regulatory program ‘is exempt from the substantive portions of CEQA.’” The court found the DPR’s record supporting the dinoteferan registration actions to be 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.
The court’s analysis of the two registration approvals focused on the potential effect of these actions on honeybees. The court found that the administrative record compiled by DPR did not demonstrate that DPR meaningfully addressed potential alternatives to the registration amendments, and that DPR must consider alternatives even when it makes a finding that approved changes would have no significant environmental impact. The court also found that DPR did not demonstrate that it properly assessed the “baseline” existing conditions prior to approval of the amendments, or the cumulative effects of these existing conditions and the new actions on honeybees. The court additionally found that DPR should have recirculated its decision for further comment because the explanation of its decision was inadequate to allow meaningful public comment. The court stated that “in light of the Department’s pending neonicotinoid reevaluation, its initial public reports for Venom Insecticide and Dinotefuran 20SG were both so inadequate and conclusory that public comment on the draft was effectively meaningless.” Based on all of these factors, the court remanded the matter to the trial court with instructions to direct DPR to rescind the two approvals.
That the court focused the basis for its decision on its finding that DPR failed to compile a record adequate to show that it met the substantive standards for decision established by CEQA is of concern to many industry stakeholders. The court stated it was “perplexed” by how DPR could determine that the label amendments to allow new uses and use rates would have no significant impact on honeybees, when DPR is still engaged in a reevaluation of the effect of all neonicotinoid pesticides on pollinators. In particular, the court was not persuaded that DPR made any meaningful evaluation of cumulative impacts because DPR only observed in “conclusory fashion” that “the uses are already present on the labels of a number of currently registered neonicotinoid containing products.” This finding is of significant concern to registrants and will be monitored closely.
More information on neonicotinoids is available on our blog.
By Lisa M. Campbell and Lisa R. Burchi
On May, 24, 2017, the California Department of Pesticide Regulation (DPR) issued guidance regarding its Notice 2015-13 to applicants registering pesticide impregnated materials bearing pesticide claims to be sold and distributed into or within California, per Notice 2015-13, issued December 11, 2015. Each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017.
The guidance includes information on the registration requirements, as well as:
More details on the requirements are available in our blog items California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims and California DPR Extends Filing Date to Register Pesticide Impregnated Products.