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.
By Lynn L. Bergeson, Lisa R. Burchi, and Margaret R. Graham
A tentative ruling issued January 26, 2017, in Monsanto Company v. Office of Environmental Health Hazard Assessment, et al., Case No. 16 CE CG 00183, by the Superior Court of California, County of Fresno, granted the Office of Environmental Health Hazard Assessment’s (OEHHA or Defendant) motion for judgment on the pleadings as to Monsanto Company’s (Monsanto) petition and complaint, and sustained the demurrers to Monsanto’s petition and complaint (Sierra Club) and California Citrus’ complaint in intervention, for failure to state facts sufficient to constitute a cause of action. The tentative ruling was issued prior to the hearing date of January 27, 2017. If this ruling is made final, Monsanto’s case will be dismissed, but Monsanto has stated it will challenge the tentative ruling.
Monsanto’s complaint alleged various violations committed by OEHHA under the U.S. and California Constitutions in listing glyphosate on the Proposition 65 (Prop 65) list of chemicals that are known to the state to cause cancer. Monsanto argues, for example, that OEHHA engaged in an unconstitutional delegation of its rulemaking authority to the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) when it used the IARC’s classification of glyphosate as “probably carcinogenic to humans” as the basis for the Prop 65 listing. Specifically, Monsanto argued that the Labor Code listing mechanism upon which the glyphosate listing is based is unconstitutional because OEHHA “cedes the basis of its regulatory authority to an unelected and non-transparent foreign body that is not under the oversight or control of any federal or state government entity.” The five constitutional violations that Monsanto claimed are: (1) a violation of the due process clauses of the California and U.S. Constitutions; (2) a violation of free speech under the California and the U.S. Constitutions; (3) a violation of the Guarantee Clause of the U.S. Constitution; (4) a violation of the California Constitution regarding the naming/identifying of IARC (Article II, Section 12); and (5) a violation of the California Constitution through empowering IARC to make laws applicable to California (Article IV, Section 1).
The tentative ruling details the court’s arguments concerning Monsanto’s failure to state facts/insufficiently allege its claims for each of the claims. Concerning the first allegation on the unconstitutional delegation of authority, the court stated “there is no support for Monsanto’s conclusion that the OEHHA has unconstitutionally delegated its rulemaking authority to the IARC,” since, in part, “the voters and the legislature have established the basic legislative scheme and made the fundamental policy decision with regard to listing possible carcinogens under Proposition 65, and then allowed the IARC to make the highly technical fact-finding decisions with regard to which specific chemicals would be added to the list.” The court also found no support for any of Monsanto’s other claims. As of February 1, 2017, the ruling was not yet made final.
By Lisa M. Campbell and Lisa R. Burchi
The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3) increase communication between growers and schools/child day care facilities; and (4) provide information to assist schools and child day care facilities in preparing for and responding to pesticide emergencies.”
This proposal has been long anticipated, is far reaching, and of significant concern to many growers and registrants.
In its Initial Statement of Reasons, DPR summarizes the proposed regulations, stating that they will: “require growers to notify public K-12 schools, child day care facilities (except family day care homes), and county agricultural commissioners when certain pesticide applications made for the production of an agricultural commodity near a schoolsite are planned in the coming year and also a few days prior to the applications.” The proposed regulation also would prohibit at certain times certain pesticide applications near these schoolsites. Specifically, the regulation is proposed to do the following:
- Prohibit many pesticide applications for the production of an “agricultural commodity” within a quarter mile of schoolsites from Monday through Friday between 6:00 a.m. and 6:00 p.m. “Schoolsites” are defined by Education Code section 17609(f) as: “‘any facility used as a child day care facility, as defined in Section 1596.750 of the Health and Safety Code, or for kindergarten, elementary, or secondary school purposes. The term includes the buildings or structures, playgrounds, athletic fields, vehicles, or any other area of property visited or used by pupils.” ‘Schoolsite’ does not include any postsecondary educational facility attended by secondary pupils or private kindergarten, elementary, or secondary school facilities.” DPR also proposed to exclude from the definition of schoolsite any family day care homes “because, unlike other schoolsites, the locations of these facilities are not publically available.” DPR states it considered other distances but proposed the one-quarter mile radius based on several factors, including but not limited the fact that this restriction is similar to the restrictions on fumigant labels that prohibit closer applications around schools and other difficult to evacuate sites and based on an analysis of pesticide illnesses due to drift from agricultural applications. The proposed prohibition would apply to applications by aircraft, sprinkler chemigation equipment, air-blast sprayers, and fumigant applications. In addition, dust and/or powder pesticide applications would also be prohibited during this time unless applied as a dust or powder using field soil injection equipment.
- Require California growers and pest control contractors to notify public K-12 schools and child day-care facilities and county agricultural commissioners (CAC) when certain pesticide applications are made within a quarter mile of these schools and facilities.
Under the proposed regulation, California growers would be required to provide two types of notifications to a school or child day-care facility:
An annual notification that lists all the pesticides expected to be used during the upcoming year. This must be provided to the school or child day care facility administrator by April 30 each year. The notice must include, among other things:
The name of pesticide products (and the main active ingredient) to be used;
A map showing the location of the field to be treated;
Contact information for the grower/operator and the County Agricultural Commissioner; and
The web address for the National Pesticide Information Center where additional sources of information or facts on pesticides may be obtained.
An application-specific notification which must be provided to the school or child day-care facility 48 hours before each application is made. This begins January 1, 2018, and must include, among other things:
- Name of pesticide products (and the main active ingredient) to be used;
- Specific location of the application and the number of acres to be treated; and
- Earliest date and time of the application.
Comments on the proposed regulation are due by November 17, 2016. DPR states that a final regulation is expected to become effective in September 2017.
Many have concerns with the proposed regulation, which DPR has been discussing publicly for some time. These concerns include what many believe are significant economic impacts to growers and others that they believe may not have been adequately considered and are not necessary for appropriate use of registered pesticides. Registrants and others should review the proposal carefully.
By Lisa M. Campbell and Timothy D. Backstrom
On May 11, 2016, the U.S. Court of Appeals for the Ninth Circuit issued an unpublished memorandum decision in an environmental justice case, Garcia v. McCarthy, Case No. 14-15494, that many have been watching closely. The Ninth Circuit affirmed a decision by the U.S. District Court dismissing the Plaintiffs’ Complaint for lack of subject matter jurisdiction. The District Court case involved an effort by the original complainants (parents of Latino school children) to obtain judicial review of a decision by the U.S. Environmental Protection Agency (EPA), to enter into a voluntary compliance agreement with the California Department of Pesticide Regulation (CDPR). The original administrative complaint filed in 1999 alleged that CDPR “authorized the use of methyl bromide and other pesticides in a fashion that had a disproportionately harmful effect on Latino school children in violation of Title VI.” Although EPA made an initial finding of a prima facie violation of Title VI, Plaintiffs asserted that EPA did not inform the complainants of the status of their complaint while the matter was being investigated and did not allow them to participate in settlement negotiations.
In challenging EPA’s settlement with CDPR, Petitioners alleged that EPA acted arbitrarily and capriciously by limiting its investigation to methyl bromide exposure between 1995 and 2001, and by failing to allow for Plaintiffs’ participation in settlement negotiations. The Ninth Circuit followed the Supreme Court enforcement discretion case Heckler v. Cheney, 470 U.S. 821 (1985), finding that EPA’s decision to settle the matter was also committed to EPA discretion by law. The Ninth Circuit stated:
- [Petitioners’ allegations] are entirely untethered to any statutory provision or regulation implementing Title VI. None of the statutes or regulations cited by plaintiffs provide a meaningful standard for defining the limits of EPA’s discretion in investigating a complaint, and none require EPA to permit plaintiffs to participate in EPA’s settlement negotiations. EPA’s plenary authority to either accept, reject, or refer a complaint to another federal agency, 40 C.F.R. § 7.120(d)(1)(i), must necessarily include the lesser power to determine the scope of the investigation in the event the complaint is accepted.
EPA’s original decision finding a prima facie violation of Title VI by CDPR was surprising and concerning to many. The current challenge to EPA’s decision to resolve the complaint through a voluntary settlement with CDPR raised additional environmental justice concerns. Some industry observers were concerned about the possibility that the Ninth Circuit might view EPA’s decision to exclude the complainants from settlement discussions with disfavor. The decision by the Ninth Circuit to affirm the District Court’s dismissal means that EPA will retain substantial discretion to negotiate appropriate settlements, even though it determines a Title VI complaint is meritorious.
By Lisa R. Burchi and Lisa M. Campbell
On December 11, 2015, the California Department of Pesticide Regulation (DPR) issued California Notice 2015-13 that will require each person/company with products made from pesticide impregnated material that are sold into or within California under their own company name to register their product(s) as a pesticide. Examples of pesticide impregnated materials affected by this Notice include apparel (e.g., jackets, shirts, hats, socks, pants, shorts) and non-apparel (e.g., bedding, tents, seat covers, chopping blocks, shower curtains, mouse pads) that make pesticidal claims.
The requirements will be effective November 1, 2016.
DPR currently registers a number of pesticide impregnated textiles bearing pesticidal claims. DPR notes that while these products have been registered either by the manufacturer of the pesticide impregnated material or by the company impregnating the bolts of fabric or clothing, individual companies selling items made from pesticide impregnated textiles were not required to register the materials. Instead, such companies were required only to obtain a pesticide broker’s license from DPR. Under DPR’s new policy, “obtaining a broker’s license will no longer be sufficient for companies selling products under their own company label” (emphasis in original). DPR states it is making this change to “facilitate tracking the use of these products in California and aid in the understanding of potential impacts on water quality and human health.”
With regard to registration requirements for pesticide impregnated products, DPR states that the number of registrations required will depend on several factors, including whether there are different pesticide active ingredients, different percentages of active ingredients, different types of fabrics, and/or different product uses. DPR states that if the product contains the same type and percentage of active ingredient, one registration can be used to cover various types of pesticide impregnated apparel or non-apparel product use categories, but such determination will be made on a case-by-case basis. As an example of products requiring separate registrations, DPR states: “If, for example, a person/company sells apparel impregnated with 0.52% of the active ingredient permethrin and other apparel impregnated with 0.48% of the active ingredient permethrin, two separate apparel registrations will be required because they contain different percentages of active ingredient. The same holds true for a category of non-apparel products.”
This Notice is a significant change in policy, and will impose potentially complicated and costly registration requirements on companies that sell pesticide impregnated material under their own company name but are not necessary familiar with pesticide registration requirements. The number of new registrations that could be required could be substantial considering the number of factors DPR has specified that could trigger separate registrations.
Importantly, DPR clarifies that this Notice is not intended to change its general policy exempting from registration those products that satisfy the requirements to be a treated article. DPR notes that for treated articles, the pesticide, and any related claims, must be related to protection of the article/substance itself. These products are thus distinguishable from pesticide impregnated materials that include pesticidal claims that are not limited to protection of the material.
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.