By James V. Aidala
On December 15, 2017, the U.S. Environmental Protection Agency (EPA) announced its release of preliminary ecological and human health risk assessments for three neonicotinoid insecticides: clothianidin, thiamethoxam, and dinotefuran, as well as a preliminary ecological risk assessment for imidacloprid, assessing risks to birds, mammals, non-target insects, and plants. The assessments are available in the dockets linked below:
EPA also released new cotton and citrus benefits assessments for foliar applications of the neonicotinoids as well as its response to public comments on the 2014 Benefits of Neonicotinoid Seed Treatment to Soybean Production. These are available in Docket No. EPA-HQ-OPP-2014-0737.
For all of the dockets listed above, EPA states that it is particularly interested in public comment on the benefits for cotton and citrus, since previous assessments identified potential risks to pollinators. Further, EPA states that “early input from the public will be helpful in developing possible mitigation options that may be needed to address risks to bees. Among the benefits identified, the neonicotinoids were found to be critical for management of Asian citrus psyllid -- which causes citrus greening, a devastating pest for citrus growers, and for control of plant bugs and stink bugs in cotton.” The comment period will begin when the Federal Register notice is published and will be open for 60 days. EPA states that it plans to release the final pollinator risk assessments and proposed interim decisions for these chemicals in mid-2018.
These documents EPA has added to the dockets linked above add to a trove of continued EPA assessments of the neonicotinoid compounds. In January 2016, EPA assessed the risks to pollinators and concluded that the seed treatment uses are generally not of concern, but that there are possible risks of importance in citrus and cotton production. This is why this recent batch of documents, including the benefits assessments of the neonicotinoid products in citrus and cotton production, along with the long-awaited response to comments to EPA’s earlier benefit assessment of the soybean use, has been anticipated for some time. In summary, the benefits assessment for both cotton and citrus indicate significant benefits for these uses. And regarding the earlier benefits assessment of soybeans, EPA now concludes that it underestimated the benefits of the soybean uses generally and in particular has concluded significant benefits in some regions from soybean seed treatments.
With EPA now concluding these uses have significant benefits, there may be some need for risk mitigation of certain use patterns, but generally the estimated benefits will offset and preclude the imposition of more general label restrictions for these crops. For example, the benefits assessment for the citrus uses states flatly that the continued sustainability of the citrus crop requires continued use of the neonicotinoid products (to control the insect that is the vector for citrus greening disease).
Regarding other formulations and risk to organisms other than honeybees, the documents do identify some possible adverse impacts on non-target aquatic insects, birds, and possibly some aquatic invertebrates. These initial findings will likely continue to fuel the debate about the impacts of neonicotinoid use. Registrants will likely submit significant amounts of rebuttal data to further refine these risk estimates and currently do not anticipate significant additional label restrictions as a result, especially since EPA has concluded these products have more significant economic benefits which will be part of any risk-benefit considerations as EPA moves forward.
More information on neonicotinoid issues is available on our blog under key word neonicotinoids.
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, Jason E. Johnston, M.S., and James V. Aidala
On May 25, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of ecological risk assessments for four neonicotinoid active ingredients for public comment as well as the Registration Review Update for Four Neonicotinoid Insecticides (Update). 82 Fed. Reg. 24113. The ecological risk assessments are:
EPA states that public comments “could address, among other things, the Agency’s risk assessment methodology and assumptions applied to its draft risk assessments, such as its methodology for estimating colony-level risk to bees from exposure to bee bread.” Comments on the three ecological risk assessments are due by July 24, 2017.
The main focus of the Update document is EPA’s efforts to harmonize the risk assessment and management of the four neonicotinoids during registration review. EPA has identified additional pollinator exposure data and pollinator toxicity data needs; registrants have committed to producing the needed data, and most of the data will be submitted in 2017. EPA plans to produce final pollinator risk assessments for both agricultural and non-agricultural uses in 2018. Release of non-pollinator risk assessments (i.e., aquatic organisms, terrestrial mammals, and birds) is planned for 2017. Human health risk assessments are also scheduled to be issued in 2017. EPA has stated that mitigating risk from the uses of all neonicotinoids may be considered for all four compounds at the same time to ensure consistent risk management and to prevent unnecessary shifts in usage between the compounds without a reduction in risk. EPA intends to release final pollinator assessments and proposed interim decisions for registration review for all four neonicotinoids in 2018.
From the EPA website, the following general statement summarizes what EPA has found so far:
- The assessments for clothianidin, thiamethoxam, and dinotefuran, similar to the preliminary pollinator assessment for imidacloprid showed: most approved uses do not pose significant risks to bee colonies. However, spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.
To some degree, it is reassuring that widespread adoption of the neonicotinoid products appears not to be an overwhelming or altogether unanticipated risk to pollinators. For insecticides, that foliar spray applications could be harmful is not good news, as any direct contact of an insect (bees) and insecticides usually is not good for the health of the insect.
Another point some may find reassuring is that EPA has not found seed treatment with neonicotinoid products to be of significant risk. This is ironic to some degree, since one of the fundamental assumptions not long ago among many beekeepers was that the seed treatment products were a singular and significant cause of the increase in colony decline and loss.
EPA’s description of the registration review status of these products also indicates that a great volume of additional data concerning possible pollinator risks is due to arrive over the next six to 18 months. Obviously, the results of these additional studies will fundamentally inform the EPA risk assessment conclusions. At the same time, one legacy of the Obama Administration in this space, the development of state Manage Pollinator Protection Plans (MP3), also will be impacted by what EPA discovers from this volume of soon-to-arrive data.
Until then, and until the new political leadership of the agency indicates any direction on pollinator issues, it is unclear whether the pollinator issue will remain one of the priority issues for program attention, or be folded into the general timeline and normal course or registration review over the next few years.
By Lisa M. Campbell and Timothy D. Backstrom
In two recent orders issued in the neonicotinoid seed treatment case Anderson v. McCarthy, the U.S. District Court for the Northern District of California declined to take immediate action in response to a motion by the U.S. Environmental Protection Agency (EPA) requesting that the Court dismiss the case for lack of subject matter jurisdiction. This case involves allegations by a coalition of beekeepers, farmers, and non-governmental organizations (Petitioners) that EPA has incorrectly applied the treated article exemption to seeds coated with neonicotinoid pesticides.
The Court issued an order denying the EPA motion to dismiss on May 13, 2016. In that order, the Court concluded that factual issues to be resolved in deciding whether a 2013 EPA guidance document constitutes a final reviewable action are so “intertwined” with the substantive issues in the case that it would be inappropriate to try to resolve the jurisdictional issues until after the filing of summary judgment motions. The Court stated:
- If the 2013 Guidance did consummate a new rule, and thus a final agency action, then defendants clearly violated federal law by failing to comply with rulemaking requirements. If the 2013 Guidance did not constitute final agency action, then subject-matter jurisdiction is lacking, and the case must be dismissed.
In the May 13, 2016, order, the Court also stated that the decision to defer action on the jurisdictional issues was a “close call,” because “defendants put forth a strong argument in support of dismissal of the lawsuit at the Rule 12 stage.”
On May 23, 2016, EPA filed another motion requesting that the Court clarify the May 13, 2016, order. In its clarification motion, EPA pointed out that the May 13, 2016, order addressed only three of the counts in the complaint challenging the 2013 Guidance, but did not address Count II, which alleged a general “failure to act” because EPA has not regulated neonicotinoid coated seeds as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA, resolution of this count involves a “pure issue of law,” because the Petitioners “failed to identify any discrete, legally-required action that EPA has failed to perform.”
The EPA motion for clarification was scheduled to be heard on July 21, 2016, but the Court issued an order on July 14, 2016, vacating that hearing. The new order stated that “defendants raised a fair point,” because “the Court’s order on the motion to dismiss failed to expressly come to grips with that part of the motion directed at the ‘failure to act’ claim for relief.” Nevertheless, the Court concluded that “no harm will be done in postponing resolution of that issue until summary judgment.”
Although the Court has declined to rule on any jurisdictional question concerning the Petitioners’ complaint posed by EPA until after the parties have filed their respective motions for summary judgment, this case may still be dismissed once the Court engages in the requisite fact-finding. When the Court stated that EPA made a “strong argument” in support of immediate dismissal, it appeared to be a clear signal that this case may yet be resolved on jurisdictional issues. The Court may decide based on the record whether the 2013 Guidance was intended to change or to modify the existing policy on applicability of the treated article exemption to coated seeds. The Court may also consider whether or not EPA intended the policy set forth in the 2013 Guidance to be binding in deciding whether or not to bring subsequent enforcement actions. In addition, the Court will need to consider whether it can review a general “failure to act” in the absence of any allegation that EPA was required to take some specific action.
By Lisa M. Campbell and Lisa R. Burchi
On March 10, 2016, the U.S. Environmental Protection Agency (EPA) filed a motion to dismiss for lack of subject matter jurisdiction and a supporting memorandum of law (Memorandum) in Anderson v. McCarthy, Case No. 3:16-cv-00068 (N.D. Cal. filed Jan. 6, 2016). In support of its motion, EPA states that the District Court lacks jurisdiction because three of the four claims stated in the complaint “seek review of a guidance document that does not constitute ‘final agency action’ reviewable under the Administrative Procedure Act [APA] or the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA],” and that the remaining claim “which asserts a failure to regulate under and enforce [FIFRA], fails because Plaintiffs have not identified a clearly imposed duty on the part of EPA to take some discrete action to regulate under or enforce the Act.”
The Complaint was filed by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners) who requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the “treated article” exemption under FIFRA. Petitioners argue, in part, that the following language from EPA’s 2013 Inspection Guidance (Guidance) provides a new interpretation of the scope of the “treated article”:
Inspectors may also take into account any locations of treated seed planting when identifying locations of potential pesticide sources. Note: Treated seed (and any resulting dust-off from treated seed) may be exempted from registration under FIFRA as a treated article and as such its planting is not considered a “pesticide use.” However, if the inspector suspects or has reason to believe a treated seed is subject to registration (i.e., the seed is not in compliance with the treated article exemption), plantings of that treated seed may nonetheless be investigated.
The Complaint argues that this Guidance improperly expanded the scope of the treated article exemption and was in effect an unlawful rule issued without prior notice and comment. The Complaint seeks an order from the District Court declaring, in part, that “unregistered seeds do not fit within the ‘treated article’ exemption from pesticide regulation in 40 CFR § 152.25(a) and must be regulated as pesticidal products under FIFRA.”
With regard to the scope of the treated article exemption, EPA in its Memorandum states that the language from the Guidance, which is for the use of inspectors and not the general public, is:
[A] far cry from prescribing the law or policy as to exemption of treated seed as a treated article under 40 C.F.R. § 152.25(a), as they in no way implement, interpret, or prescribe law or policy. Instead, this language in the Inspection Guidance is but one recommendation to inspectors who are investigating all possible sources of pesticides, including treated seed.
EPA further argues that the “note” in its Guidance is “nothing more than the unremarkable reiteration of EPA’s longstanding view of the treated article exemption in 40 C.F.R. § 152.25(a).” EPA states that the applicability of the treated article exemption has been discussed publicly by EPA since 2003 in an document published jointly by EPA and Canada Pest Management Regulatory Agency entitled “Harmonization of Regulation of Pesticide Seed Treatment in Canada and the United States.” In that document, EPA states that it “plainly indicates that where the conditions of the treated article exemption are met, ‘[s]eeds for planting which are treated with pesticides registered in the U.S. are exempt from registration as pesticides and may be freely distributed and sold within the U.S.’” Thus, EPA states that Petitioners “have failed to meet their burden to demonstrate that the Inspection Guidance (or any other action) constitutes “final agency action” as that term is used in the APA, and thus they have not met their burden of demonstrating jurisdiction.”
On March 16, 2016, Intervenor-Defendants CropLife America, the American Seed Trade Association, the American Soybean Association, the National Cotton Council of America, the National Association of Wheat Growers, the National Corn Growers Association, and the Agricultural Retailers Association filed to join EPA’s Motion to Dismiss.
More information on the complaint is available in our blog item EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA.
By Lisa M. Campbell and Timothy D. Backstrom
On January 6, 2016, a complaint was filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Northern District of California by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners). The Petitioners allege that EPA has allowed “the ongoing sale and use of unregistered pesticide products” because, they claim, EPA has incorrectly construed seeds coated with neonicotinoid insecticides to be “treated articles” exempt from registration under 40 C.F.R. § 152.25(a). Petitioners argue that a 2013 guidance document prepared by EPA for enforcement personnel investigating bee incidents improperly expanded the scope of the “treated article” exemption and was in effect an unlawful rule issued without prior notice and comment.
According to Petitioners, seeds coated with neonicotinoid pesticides should not be considered eligible for the “treated article” exemption because the neonicotinoid pesticide in the coating acts systemically to protect the growing plants after the seeds germinate, rather than to protect the seeds themselves. Based on this analysis, Petitioners argue that each coated seed product is in fact a separate unregistered pesticide that has not been properly evaluated under FIFRA. Petitioners also argue that pesticide loss from these coated seeds has a variety of collateral environmental effects, including effects on pollinators that EPA has not appropriately considered.
The Petitioners have requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the treated article exemption. Petitioners also request that the District Court enjoin EPA from: (1) allowing any new unregistered neonicotinoid-coated seeds of any crops; and (2) allowing any new unregistered seeds of any crops if they are coated with other systemic insecticides that cause pesticidal effects extending beyond the coated seed and plant itself.
The potential consequences of a reviewing court finding that EPA has improperly construed or expanded the “treated article” exemption by including seeds coated with neonicotinoid insecticides are of significant concern. Such a construction could require that EPA separately register each type of coated seed under FIFRA, regardless of whether EPA adequately evaluated the risks associated with seed treatment when each insecticide was first registered for this use. EPA could seek dismissal of some or all of the Petitioner’s claims on jurisdictional grounds, arguing that the risks and benefits of seed treatment were considered at the time each neonicotinoid insecticide was registered for such use, and that the Petitioners should have sought prior review of those registration decisions in the Court of Appeals within the applicable 60-day window. EPA may also object to the apparent failure of the Petitioners to exhaust their administrative remedies before challenging the policy embodied in the purported “rule,” and also to the Petitioners’ extensive reliance on extra-record evidence.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On January 6, 2016, the U.S. Environmental Protection Agency (EPA), in collaboration with California’s Department of Pesticide Regulation (DPR) announced the release of a preliminary pollinator risk assessment for the neonicotinoid insecticide, imidacloprid (Preliminary Risk Assessment or Assessment). In its assessment, EPA states that imidacloprid potentially poses a risk to hives when the pesticide comes in contact with certain crops that attract pollinators.
EPA coordinated efforts with Canada’s Pest Management Regulatory Agency (PRMA). PMRA simultaneously released the overview and science evaluation of its imidacloprid pollinator-only assessment, which reaches the same preliminary conclusions as set forth in EPA’s Assessment. PMRA plans to release the complete assessment with appendices as a revised version on January 18, 2016, and to accept written comments until March 18, 2016.
EPA’s Preliminary Risk Assessment will be subject to a 60-day comment period commencing on the announcement of the Assessment in the Federal Register. EPA did not indicate how long it will be before the Federal Register notice is issued.
This Assessment is the first of four such assessments that will be prepared in 2016 under President Obama’s National Pollinator Strategy. The other three assessments, for neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, are scheduled to be released for public comment in December 2016. EPA also states that following the receipt of public comments on this Assessment by December 2016, it plans to issue a revised Preliminary Ecological Risk Assessment that will: “(i) consider any comments or information submitted in response to this bee-only preliminary risk assessment; (ii) incorporate additional data EPA anticipates to receive that is relevant to bees; and, (iii) assess the potential risks of all registered uses of imidacloprid to all taxa.”
EPA’s Preliminary Risk Assessment describes how EPA conducted a screening level assessment (Tier I) for the various uses of imidacloprid, with a stepwise, tiered risk assessment approach evaluating risks to individual bees first and, if needed, risks to the colony. EPA has divided its risk findings for honey bees for the registered use patterns of imidacloprid into three categories: (1) Crop Groups/Use Patterns that Present Low On-Field Risk; (2) Crop Groups/Use Patterns with Uncertainty in Colony (Tier II) Assessment; and (3) Crop Groups/Use Patterns with Colony (Tier II) Risk Indicated, with this last category including “Citrus Fruits (Oranges)” and “Oilseed (Cotton).” EPA further states: “Based on a tri-agency analysis of the statistical and biological considerations of the data, a NOAEC and LOAEC of 25 and 50 μg a.i./L in nectar were determined based on reductions of the number of adult workers, numbers of pupae, pollen stores and honey stores which persisted across much of the study duration. The level of imidacloprid in nectar at or below which no effects would be expected to the colony is determined to be 25 μg a.i./L.”
Additional information regarding EPA’s actions regarding neonicotinoid insecticides and the National Pollinator Strategy can be found on our blog. EPA stated its intent to hold a webinar regarding the imidacloprid Preliminary Risk Assessment in early February 2016. More information can be found on EPA’s website.
EPA’s statements about the assessment have indicated that imidacloprid uses on citrus and cotton are of greatest concern. Not included in this assessment is what, if any, specific regulatory actions might be needed to reduce any risks to an acceptable level. Regardless, the registrants, along with other stakeholders, will almost certainly comment on the assessment (likely to say that the risks are both overestimated, according to the registrants, and underestimated, according to environmental groups).
What may be of less notice is what EPA appears to conclude about the other uses of the pesticide. Not long ago, many claimed that significant honeybee decline was due to planting crops, especially corn, with neonicotinoid seed treatments such as imidacloprid. This assessment appears to contradict that assertion (along with other improvements that have been made in reducing fugitive dust exposures during application). And, even if EPA is correct in its assessment that the citrus and cotton uses are of concern, there are many other uses of imidacloprid currently suspended from the market in the European Union (EU) -- where cotton and citrus are not widely produced. This EPA assessment might become part of the debate about the rationale behind the current EU policies.
The documents released today are long (the assessment is 305 pages with an appendix of 212 pages). That EPA plans to complete its assessment within this calendar year indicates that current EPA leaders want any decision to be issued (or at least be framed) before the arrival of any new Administration. That alone will cause some to question the degree to which any actions are based more on “science and data” or on the “politics” of pollinator protection.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
In a press release issued on November 22, 2015, the Canadian province of Québec (Quebec) announced its release of Québec Pesticide Strategy 2015-2018. Although the Strategy itself is available only in French, Québec has provided a summary of the Strategy in English, which is available here.
Québec’s press release states that the Strategy “sets out the major directions and goals that will guide government action to protect public health, pollinators, and the environment in the coming years.” One of the ways the Strategy seeks to do this is to impose additional restrictions on the use of the "highest-risk pesticides" which the Strategy states includes atrazine, chlorpyrifos, and neonicotinoid insecticides. To reduce use of high risk pesticides, the Strategy’s “Objectives” to be implemented through legislative and regulatory changes include:
- Requiring agricultural application of such highest-risk pesticides to be "justified by an agronomist in advance of 100% of cases";
- Tripling of the number of pesticides that are banned in urban environments for use on lawns and green spaces;
- Obliging owners of golf courses that use the greatest amount of pesticides to reduce their use of the highest-risk products by 25 percent; and
- Authorizing the "unrestricted sale of all biopesticides by all retailers" and encouraging “the application of the lowest-risk pesticides through economic incentives (levies, permits and compensation fees).”
To lower exposures, the Strategy calls for ensuring adequate qualification levels for employees that apply pesticides and increasing mandatory minimum distance when pesticides are applied near inhabited areas.
With specific regard to neonicotinoid insecticides, Québec seeks to reduce such use with the following “Objectives,” some of which overlap with the Objectives noted above for high risk pesticides:
- Banning the use of all neonicotinoids for lawn and flower bed maintenance;
- Requiring agricultural application of such neonicotinoids to be "justified by an agronomist in advance of 100% of cases"; and
- Encouraging the use of seeds uncoated with neonicotinoids through economic incentives such as levies, permits, and compensation fees.
Québec also intends to obtain additional information about use of treated seeds in Quebec by requiring companies to submit reports on Québec sales of neonicotinoid-treated seeds.
Québec in its Strategy summary also describes the following specific activities it plans to undertake in 2016:
- Amend the Pesticides Management Code to “tighten the conditions under which pesticides may be used”;
- Modernize the Pesticides Act to incorporate coated seeds and strengthen compliance through a system of administrative penalties; and
- Hold pesticide users accountable by “having users of highest-risk pesticides assume a greater share of associated environmental and public health costs.”
Québec’s Strategy to impose additional restrictions on the use of the "highest-risk pesticides," including neonicotinoid insecticides, is part of its efforts following a 2011 strategy aimed at reducing the risks related to pesticide use by 25 percent by 2021. The Canadian province of Ontario also issued final regulations in June 2015 aimed at reducing the area planted with maize and soybean seed treated with neonicotinoid insecticides as discussed in our blog item Canadian Province Finalizes Neonic Reduction Rule, although Quebec’s Strategy goes arguably farther by broadening the scope of the pesticides at issue to include atrazine and chlorpyrifos. It remains to be seen whether different rules in different provinces will create any confusion or other regulatory issues for companies seeking to comply with these restrictions.
In the U.S., the issue of forbidding “prophylactic” use of pesticides has been raised to date primarily at the local level in a relatively few number municipalities. Regarding pollinator issues more generally in the U.S., the U.S. Environmental Protection Agency (EPA) is in the process of reviewing comments it received on its “Proposal to Mitigate the Exposure to Bees from Acutely Toxic Pesticide Products” released earlier this year. The next milestone in EPA activity related to neonicotinoid pesticides is the expected release of a registration review risk assessment document for imadicloprid, a widely used neonicotinoid insecticide, before the end of the calendar year.
More information on pesticides and pollinators is available on our blog under topics "pesticides" and "pollinators."
NAFTA TWG on Pesticides Meeting
By Lisa M. Campbell and Margaret R. Graham
On November 3-5, 2015, the North American Free Trade Agreement (NAFTA) Technical Working Group (TWG) on Pesticides, established in 1997 to streamline certain pesticide shipments between Canada (CN), Mexico (MX), and the United States (U.S.), held a meeting hosted by the U.S. Environmental Protection Agency in Durham, North Carolina. NAFTA TWG states that its primary objective “is to develop relevant and cost-effective pesticide regulation and trade among the three countries and meet the environmental, ecological, and human health objectives of NAFTA.” Further, TWG partners address trade issues, national regulatory and scientific capacity, governmental review burden, and coordination of regulatory decision making and industry burden reduction.
The topics discussed at its November meeting, a government-stakeholder meeting with the Executive Board, regulatory officials, and interested stakeholders such as growers, industry, and public interest groups, were:
Five-Year Strategic Plan and NAFTA Industry Working Group (IWG) Updates. The presentation was as follows:
Science and Policy Initiatives:
- Updates on Pollinator Protection in the U.S., CN, and MX. The presentations were as follows:
“Update on Pollinator Protection Activities in the U.S.” (Lead: U.S. - Rick Keigwin);
“Pollinator Protection in Canada” (CN - Scott Kirby);
MX’s input regarding “US EPA Guidance for Assessing Pesticide Risks to Bees” (Lead: MX -
SEMARNAT or SENASICA);
“Update on Mexican Project: Preliminary Study on Some Factors That Influence on Bee Colony
Loss in Different Regions of Apicultural Importance in Mexico” (Lead: MX - Nelly Peña); and
“Pollinator Update: US, CN, and MX” - Presentation on Behalf of IWG on Pesticides (Lead: CN -
Maria Trainer, CropLife Canada).
- Re-evaluation of Neonicotinoid Pesticides Update in the U.S. and Canada. The presentation was as follows:
“Update on Re-evaluation of Neonicotinoid Pesticides in the U.S. and CN” (Leads: U.S. -
Don Brady and CN - Margherita Conti).
- Minor Use Program Developments. The presentations were as follows:
“Joint Minor Use Updates” (Leads: U.S. - Susan Lewis and CN - Margherita Conti); and
“IR-4: Update on Local Minor Uses” (Leads: U.S. IR-4 - Dan Kunkel and MX -
Alma Liliana Tovar Diaz).
- Maximum Residue Limits (MRL)/Codex. The presentations were as follows:
“MRL Alignment Activities Update” (Leads: U.S. - Susan Lewis and CN - Yadvinder Bhuller);
“Benefits of Harmonized MRLs” (Lead: CN - Gordon Kurbis, Pulse Canada); and
“Inadvertent Residues” (Lead: CN - Craig Hunter, Ontario Fruit and Vegetable Growers’
Stakeholder Presentations and Discussions:
- Stakeholders’ Lessons Learned on Joint Reviews including Industry’s Experiences and Prospectives of Joint Reviews. The presentations were as follows:
Lead: CN - Tanya Tocheva, Syngenta Crop Protection Canada;
Lead: CN - Gordon Kurbis, Pulse Canada; and
Lead: MX - Hector Guillén, Avocado Growers Association, APAMEX.
- Progress of the TWG’s joint action plan and receipt of input on the next phase of activities.
- Discussion on Future Collaboration Regarding Joint Review.
The presentations, many of which address issues of significant controversy and debate, are of interest to many in industry and to other stakeholders.
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.