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 R. Burchi and Lisa M. Campbell
On January 2, 2018, State Attorneys General from eleven states (Idaho, Indiana, Iowa, Kansas, Louisiana, Michigan, Missouri, North Dakota, Oklahoma, South Dakota, and Wisconsin) (collectively the States) filed a friend of the court brief in Nat’l Ass’n of Wheat Growers v. Zeise, E.D. Cal. (No. 2:17-cv-02401) (Brief), a case challenging California Office of Environmental Health Hazard Assessment’s (OEHHA) decision to list glyphosate as a carcinogen under Proposition 65 (Prop 65).
OEHHA listed glyphosate under Prop 65 on March 28, 2017, but the effective date of the listing was delayed until July 7, 2017, following a decision from the Fifth District Court of Appeals that denied Monsanto’s request for a stay of such listing. OEHHA stated that its listing was required under its Labor Code listing mechanism, which OEHHA states requires it to list under Prop 65 certain substances identified by the International Agency for Research on Cancer (IARC) as known to cause cancer. Information about Monsanto’s earlier challenge is available in our blog item California Court Tentatively Dismisses Monstano’s Lawsuit Against OEHHA to Block Addition of Glyphosate to Proposition 65 List.
On November 15, 2017, a nationwide coalition of agricultural producers and business entities (including Monsanto) filed a Complaint against OEHHA on the grounds that its listing of glyphosate as a carcinogen and the Prop 65 warning requirement triggered by that listing: (1) violate the First Amendment of the U.S. Constitution by compelling Plaintiffs and other entities to make false, misleading, and highly controversial statements about their products; and (2) violate the Due Process Clause of the Fourteenth Amendment of the U.S. Constitution because OEHHA’s actions are not rationally related to any legitimate state interest; and (3) violate the Supremacy Clause of the U.S. Constitution by conflicting with, and being preempted by, the Federal Food, Drug, and Cosmetic Act (FFDCA). Plaintiffs filed an amended Complaint on December 5, 2017.
On December 6, 2017, Plaintiffs also filed a motion for preliminary injunction (Motion), arguing that they are likely to succeed on the merits of their claim that the Prop 65 listing violates the First Amendment. The Motion argues that the warning will fail under any level of constitutional scrutiny, whether it is considered under “laws regulating commercial speech that generally receive at least intermediate scrutiny, i.e., they are prohibited if they do not directly and materially advance the government’s interest, or are more extensive than necessary,” or laws that require disclosure of information in connection with commercial transactions, which “are permissible only if the compelled disclosure is of information that is purely factual, uncontroversially accurate, reasonably related to a substantial government purpose, and not unduly burdensome or chilling. See Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985).” Motion at 23-36; Complaint at 26-28.
In agreeing with Plaintiffs that OEHHA’s Prop 65 listing of glyphosate forces businesses to issue “false and misleading” statements about their products and asking the court to grant the Plaintiffs’ motion for a temporary restraining order and preliminary injunction, the Attorneys General state in their Brief:
- The First Amendment injuries identified by Plaintiffs are heightened because they adversely impact the sovereign interests of other States in at least two ways. First, by requiring false or misleading statements about glyphosate products, California’s speech mandate imposes confusing and potentially inconsistent obligations on nonresident businesses that are bound by other States’ consumer-protection laws not to make false and misleading statements about their own products. Second, the speech mandate impairs consumer-protection efforts of the States that require sensible health-and-safety disclosures by contributing to the well-known phenomenon of disclosure fatigue.
Brief at 4-5 (emphasis in original).
The States also argue that while there may be a presumption to California’s favor that its enforcement of its duly enacted laws reflects the public interest, the Court also “should weigh heavily the fact that California’s mandate interferes with federalism and the sovereign interests of other States when assessing the public interest factor.” Brief at 10.
This case raises significant constitutional and preemption arguments in a factual context that many in industry believe compelling. It will be closely monitored.
OEHHA answered Plaintiff’s First Amended Complaint on January 9, 2018. It is expected to file its opposition to Plaintiff’s Motion for a Preliminary Injunction by January 22, 2018, and file its response to the two amicus curiae briefs filed on behalf of Plaintiffs by January 26, 2018. Following deadlines for Plaintiffs to file any reply in support of their motion for a preliminary injunction and any responses to amicus curiae briefs in support of Defendants, a hearing on Plaintiff’s motion will be held on February 20, 2018.
By James V. Aidala, Lisa M. Campbell, and Timothy D. Backstrom
On December 14, 2017, the Missouri Department of Agriculture (MDA) announced that it issued and collected the first round of fines resulting from investigations regarding the pesticide dicamba. The news release states that the first wave of civil penalties issued to applicators, all from Dunklin County, were issued as “a result of investigations of complaints during the 2016 growing season,” and the “civil penalties, ranging from $1,500 to $62,250, were issued for pesticide misuse (off label use and drift).” Further, in 2016, “Department staff conducted and completed 121 complainant investigations. Those complainants named approximately 60 applicators, who were investigated as a result of complaints. In addition, the Department investigated nearly 100 non-Dicamba related incidents.”
This is the first group of what is anticipated to be a large number of dicamba-related enforcement cases, given the extensive number of, and publicity concerning, the reported incidents involving dicamba. Reported incidents in Arkansas were even more numerous than those in Missouri. About one-third of the reported incidents in Missouri have now been attributed to only six applicators. One applicator alone was cited for 149 discrete violations, which indicates that problems with the new dicamba formulations may be less widespread than some originally feared based on the large number of reported incidents. Moreover, some of the states where the new dicamba products were widely used have reported very few incidents. In the aggregate, this data suggests that better stewardship training accompanied by rigorous enforcement may be sufficient to greatly reduce the future incidence of unexpected off-site movement of the new dicamba formulations.
More information on dicamba issues is available in our blog.
By Lynn L. Bergeson and Margaret R. Graham
The American Bar Association (ABA) Pesticides, Chemical Regulation, and Right-to-Know (PCRRTK) Committee is collaborating with David Rejeski, Director of the Technology, Innovation, and Environmental Project at the Environmental Law Institute (ELI), on a project involving the law, regulation, and policy of cannabis. David has written extensively on the topic, one example of which is his article “Cannabis. The ‘Next Big Thing’ for the Environment?”
Federal Insecticide, Fungicide, and Rodenticide (FIFRA) practitioners likely noticed the cannabis item on the most recent State FIFRA Issues Research and Evaluation Group (SFIREG) meeting agenda. Also, the state of Colorado is preparing a white paper on cannabis. Many other initiatives are in play as well.
The newly formed Task Group will outline legal, regulatory, and policy issues pertinent to cannabis as a crop, the absence of tolerances, its impact on the environment, and a wide range of related issues.
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 Lisa M. Campbell and Lisa R. Burchi
On February 22, 2017, the California Department of Pesticide Regulation (DPR) announced it was extending the filing date for applications to register products made from pesticide impregnated materials bearing pesticide claims from March 1, 2017, to July 1, 2017. Specifically, 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. DPR’s California Notice 2015-13 issued on December 11, 2015, informed pesticide product registrants and stakeholders of DPR’s intention to register products made with pesticide impregnated materials and bearing pesticide claims.
The February 22 notice also states the following in terms of the requirements:
- Each company with products made from pesticide impregnated material and sold under their own company name into or within California is required to register the product(s) as a pesticide;
- The product must bear a federally approved pesticide label; DPR will assign a separate California-only registration number for purposes of tracking sales and use of the products in California;
- Each company will need to obtain at least one registration for each use category of product sold (e.g., the apparel use category includes wearable items such as jackets, shirts, hats, socks, pants, and shorts; the non-apparel use category includes non-wearable items such as bedding, tents, seat covers, chopping blocks, shower curtains, and mouse pads); and
- If items are impregnated with different pesticides or different percentages of the same pesticide, separate registrations will be required.
The requirements set forth in this notice do not apply to products that satisfy the requirements to be a treated article, including the requirement that any claims be related to protection of the article/substance itself. The notice applies instead to those pesticide impregnated materials that include pesticidal claims that are not limited to protection of the material. More information on the December 2015 notice is available in our blog item California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims.
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 Lisa M. Campbell, Susan Hunter Youngren, Ph.D., and James V. Aidala
On August 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a proposal to revise the Certification of Pesticide Applicators rule. EPA is proposing stricter standards for people certified to use “restricted use” pesticides (certified applicators). Restricted use pesticides are not available for purchase by the general public, require special handling, and may only be applied by a certified applicator or someone working under the direct supervision of a certified applicator.
The proposed stricter standards include:
- Certified applicators must be at least 18 years old;
- Those working under the supervision of certified applicators would now need training on using pesticides safely and protecting their families from take-home pesticide exposure;
- Certifications would have to be renewed every 3 years;
- Additional specialized licensing for certain methods of application that can pose greater risks if not conducted properly, such as fumigation and aerial application; and
- Updates to the requirements for States, Tribes, and Federal agencies that administer their own certification programs to incorporate the strengthened standards.
Currently, the majority of certification programs have no renewal requirements. Thus, this requirement will put additional burdens on States and Tribes administering certification programs to not only strengthen their standards under this new proposal but to incorporate a time-keeping process to ensure applicators’ renewals are kept up to date, and sufficient certification programs are available for re-certifying purposes. In addition, for some certification programs, the specialized licensing programs will need to be developed, tested, and instituted.
EPA’s proposal to update certification and training requirements comes along with the parallel effort to revise the worker protection standards (WPS), where a final rule updating those requirements are expected sometime in September. Like the revised WPS, revising the training requirements has been on EPA’s agenda for many years, and this part of the updated requirements for worker protection is expected to be less controversial than some of the changes to the WPS. In particular, since EPA has emphasized the protection of children as part of its pesticide regulatory program, making the minimum age 18 for pesticide applicators is part of that agenda.
EPA encourages public comment on the proposed improvements. Comments on the proposal are due November 23, 2015.
More information about certification for pesticide applicators is available here.