By Lisa R. Burchi and Lisa M. Campbell
On January 22, 2016, Ontario released for consultation a draft Health Action Plan (Plan) to reduce losses of honeybees and other pollinators caused by several “stressors” stated in the Plan to include: (1) reduced habitat and poor nutrition; (2) diseases, pests, and genetics; (3) exposure to pesticides; and (4) extreme weather and climate change. This action plan is part of a broader strategy to protect pollinators, with Ontario’s aim, in part, to reach an 80 percent reduction in the number of acres planted with neonicotinoid-treated corn and soybean seeds by 2017. Other actions taken by Ontario related to pollinators and the regulation of corn and soybean seeds treated with neonicotinoids are discussed in our blog item Canadian Province Finalizes Neonic Reduction Rule.
Comments can be submitted through the Environmental Registry until March 7, 2016.
The Plan “identifies potential actions that have been informed through an ongoing consultation process with key stakeholders and the broader public.” For each of the four stressors identified as a cause of the pollinator decline, the Plan summarizes what information Ontario has gathered, what potential actions it is considering, and what potential additional action areas exist. With regard to the exposure to pesticides, the Plan states the following regarding potential actions for Ontario to take and additional measures under consideration.
Potential Actions by the Province:
- Increase education and outreach activities to stakeholder groups on Best Management Practices (BMP) and integrated pest management to support the implementation of Ontario Regulation 63/09 under the Pesticides Act;
- Support integrated pest management training for growers;
- Enhance sector outreach to support beekeeper education around the use of appropriate pest treatments in-hive;
- Continue to work with industry to support agricultural production and land stewardship practices that reduce pollinator pesticides exposure;
- Explore opportunities to facilitate completion and launch of an e-tool to alert pesticide applicators of nearby beehives for the purpose of reducing bee exposures;
- Provide financial support for producers to acquire dust deflectors for planting equipment through the Great Lakes Agricultural Stewardship Initiative;
- Enhance provincial monitoring efforts to track changes in agricultural practices stemming from the implementation of Ontario Regulation 63/09; and
- Monitor neonicotinoid concentrations in the environment.
Potential Additional Action Areas:
- Profile and highlight BMPs for pesticide use in agriculture;
- Improve beekeeper education on the effectiveness of honey bee pest treatments; and
- Support research in selective breeding strategies for honey bees resistant to pests and diseases.
The Plan also discusses Ontario’s research and monitoring efforts, including its intent to align and leverage existing research programs and its consideration to launch a special “Call for Proposals” to “fund new pollinator health research projects to fill knowledge gaps for example, understanding how varroa infestations interact with other stressors, studying implications of climate change for Ontario’s pollinators and assessing the effectiveness of various land management practices.”
In addition to submitting comments on the Plan, Ontario also developed an online survey for input on what priorities should be the focus to improve pollinator health and what steps should be taken to improve pollinator health.
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.
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 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.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
The Canadian province of Ontario has issued its final regulations under the Ontario Pesticides Act aimed at reducing the area planted with maize and soybean seed treated with neonicotinoid insecticides. These changes have been made as part of its broader strategy to protect pollinators, and aim to reach an 80 percent reduction in the number of hectares planted with neonicotinoid-treated corn and soybean seed by 2017.
The new rules create a new class of pesticides, known as “Class 12 pesticides.” This class applies to corn seed grown for grain or silage, and soybean seeds treated with the following neonicotinoid insecticides: imidacloprid; thiamethoxam; and clothianidin. The new regulations will not apply to popping corn, sweet corn, corn used for the production of seed, or soybean seeds planted for the purpose of producing a soybean seed crop of certified status.
The new system established by these regulations will take effect on July 1, 2015, and be phased in over time. The elements include but are not limited to the following:
- Integrated Pest Management Training: The regulations will require farmers to complete training on integrated pest management methods. To encourage participation, training will be offered for free until September 1, 2016; after that time, training will be provided at a cost. After August 31, 2016, any person (e.g., farmer) who purchases neonicotinoid-treated seeds will be required to have completed the integrated pest management training course and received a certification number, which will be valid for five years.
- Pest Assessment Reports: Farmers wanting to buy and plant neonicotinoid-treated seed on more than 50 percent of the total area of their corn and soybean crop will need to complete a pest assessment report and provide it to the sales representative or seed vendor from which they purchase the seeds.
- Requirements for Vendor Licenses for the Sale of Neonicotinoid-Treated Seeds: The regulations will require companies selling neonicotinoid-treated seeds to obtain a treated seed vendor’s license, notify purchasers that the seed is a neonicotinoid-treated seed, and offer untreated seed for purchase, among other requirements. Growers will only be able to buy and use neonicotinoid-treated seeds that vendors have put on the "Class 12 Pesticides List," a list updated by August of each year.
- Tracking of the Sale of Neonicotinoid-Treated Seeds: The regulations will require the annual submission of the sales of treated seeds “to ensure an open and transparent system to track progress.” The Ministry of the Environment will publicly report amalgamated sales and seed treatment data for neonicotinoid-treated corn and soybean seed.
The regulations do not include requirements for the transport and storage of Class 12 pesticides.
Further information is available at the below links:
It is important to consider these new requirements in conjunction with those being developed in the U.S. EPA’s approach to date in considering additional restrictions to neonicotinoid pesticides to protect pollinators appears to focus not as much on reducing the use of products, but instead on controlling and preventing unwanted exposure of pollinators to these products.
In recent weeks, the U.S. government issued a “National Strategy to Promote the Health of Honey Bees and Other Pollinators” on May 19, and on May 28, EPA released for comment: “EPA’s Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products.”
By Timothy D. Backstrom
On June 12, 2015, Federal District Judge Maxine Chesney issued a decision in Ellis v. Housenger (N.D. Cal.) allowing the plaintiffs to utilize expert declarations and exhibits that were not included in the certified administrative record to support their contentions that the U.S. Environmental Protection Agency (EPA) improperly failed to consult the Fish and Wildlife Service (FWS) under Section 7 of the Endangered Species Act (ESA). The plaintiffs in the Ellis case are individual beekeepers and non-governmental organizations, and two out of the six claims in their complaint allege a failure by EPA to consult under the ESA before registering or adding new registered uses for products containing two neonicotinoid pesticides, clothianidin and thiamethoxam. Judge Chesney’s order was issued in response to separate motions by EPA and by industry intervenors Bayer Crop Science, Syngenta Crop Protection, and Croplife America to preclude the plaintiffs from utilizing extra record material to support their ESA claims.
Although EPA and the intervenors argued that the Court’s review of the ESA claims should be confined to the administrative record based on the Administrative Procedure Act (APA), Judge Chesney determined that extra record material may be used to support an allegation that an administrative agency failed to consult with the FWS as required by ESA Section 7. The Judge based this holding on two cases decided in the Ninth Circuit, Washington Toxics Coalition v. EPA and Western Watersheds Project v. Kraayenbrink, which each held that extra record material may be properly considered in determining whether an agency improperly failed to consult under ESA Section 7. The Judge rejected the contention by EPA and the intervenors that these two decisions were supplanted by Karup Tribe v. U.S. Forest Service, concluding that the “arbitrary and capricious” standard of review established by the APA is utilized to review the ESA claims, but the scope of review for these claims is not constrained by the APA.
The effect of this decision will be to allow the plaintiffs to present expert opinion and evidence concerning the claimed adverse effects of the two neonicotinoid pesticides on endangered and threatened species, including but not limited to pollinator species, that was not expressly considered by EPA when it decided to register these pesticides. The plaintiffs will argue that such extra record material establishes that there was a sufficient basis to conclude that these pesticides “may affect” endangered or threatened species for EPA’s failure to consult FWS under the ESA to be arbitrary and capricious. This preliminary ruling could materially affect review of the ESA counts because there is a substantial division of expert scientific opinion concerning the alleged adverse effects of neonicotinoid pesticides, and the Court may conclude that EPA did not afford adequate weight to some of this opinion.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
On May 22, 2015, the European Food Safety Authority (EFSA) issued a call for new scientific information relevant to the evaluation of the risk to bees in the European Union (EU) from the use of the three neonicotinoid pesticide active substances: clothianidin, imidacloprid, and thiamethoxam (the substances).
The call for data complies with the decision taken by the European Commission in May 2013, Commission Implementing Regulation (EU) No. 485/2013, to put in place measures to restrict the use of the substances, which at the time included prohibiting use of the active substances clothianidin, thiamethoxam, and imidacloprid as a seed or soil treatment and for pre-flowering applications on crops attractive to bees and for cereals other than winter cereals. In May 2013, the Commission also stated that within two years it would initiate a review of any new scientific information.
EFSA is urging national authorities, research institutions, industry, and other interested parties to submit all information on the effects, exposure, and risks of the three substances regarding bees -- honeybees, bumble bees, and solitary bees -- when used as seed treatments and granules. This can include:
- Literature data, including grey literature and any other data from research activities relevant to the risk assessment for bees for the uses of the three substances applied as seed treatments and granules. Data that have been provided and identified as relevant by EFSA in its published systematic literature review report need not be submitted, however.
- Study reports conducted specifically to assess the risk to bees from the three substances applied as seed treatments and granules, and not yet considered under the previous EFSA assessments (EFSA Journal 2013;11(1): 3066, 3067, 3068).
- National evaluations and/or monitoring data relevant to the risk assessment for bees for the uses of the three substances applied as seed treatments and granules that are available at the Competent Authorities of Member States and not yet considered under the previous EFSA assessments, listed in the above bullet.
- Data that EFSA stated were not relevant in its published systematic literature review report may be submitted only if accompanied with a scientific rationale supporting their relevance.
The notice states that all information should be submitted by September 30, 2015. Any information submitted can be claimed as confidential by following procedures set forth in Article 63 of Regulation (EC) No 1107/2009. EFSA will review the material provided from this call for data and offer conclusions concerning an updated risk assessment following receipt of a follow-up mandate from the European Commission.
By Lisa M. Campbell and James V. Aidala
The U.S. Environmental Protection Agency’s (EPA) Proposal to Mitigate Exposure to Bees from Acutely Toxic Pesticide Products published in the Federal Register on May 29, 2015, seeks comment on a proposal to adopt mandatory pesticide label restrictions to protect managed bees under contract pollination services from foliar application of pesticides that are acutely toxic to bees on a contact exposure basis, unless the application is made in accordance with a government-declared public health response. These label restrictions would prohibit applications of pesticide products that EPA has identified as acutely toxic to bees, during bloom when bees are known to be present under contract.
As part of this mitigation proposal, the 48-hour notification exception for crops under contracted pollination services during bloom for all neonicotinoid product labels would be removed. These restrictions are intended to reduce the likelihood of acute exposure and mortality to managed bees under contract. EPA is not proposing at this time to require new language for pesticide labels for managed bees not under contract pollination services. This does not, however, alter EPA’s previous actions intended to impose more specific restrictions on neonicotinoid pesticides through label language addressing potential risks to bees not under contract for pollination services.
EPA is also seeking comment on a proposal to rely on efforts made by states and tribes to reduce pesticide exposures for application sites not under contracted services, through development of locally-based measures, specifically through managed pollinator protection plans. These plans would include local and customizable mitigation measures to address certain scenarios that can result in exposure to pollinators. EPA intends to monitor the success of these plans in deciding whether further label restrictions are warranted.
EPA states that if it receives evidence during the public comment period, and/or through outreach at stakeholder meetings, that the contract provisions that are the subject of the proposed rule commonly considered effective and mutually agreed upon stakeholder practices (i.e., beekeeper-to-grower) indicating that the application of acutely toxic pesticides is not of risk concern for bees under contract, then EPA will consider this information in determining whether this scenario needs the mitigation indicated in the proposed language.
EPA states that the proposed actions are consistent with the Presidential Memorandum issued in June 2014 to reduce the effect of factors that have been associated with pollinator declines in general, as well as the mandate to engage state and tribal partners in the development of pollinator protection plans. Comments on the proposal are due by June 29, 2015.
The main elements of EPA’s pesticide regulatory strategies and policies were only a small part of the response to the President last week on a National Strategy for pollinators, but now that EPA has issued this proposal, attention will turn to what EPA is more precisely planning to do with regard to proposing and implementing new restrictions on pesticides generally and/or neonicotinoid products in particular.
As expected, the focus of the proposal is on new restrictions for acutely toxic pesticide applications (defined in the notice as “pesticides with an acutely lethal dose to 50% of the bees tested of less than 11 micrograms per bee”), where the pesticide application site is also where there are contracted pollination services. Essentially, foliar application of pesticides acutely toxic to bees are prohibited where there are bee colonies present pursuant to a contract to provide pollination services. EPA’s proposal (at Appendix A) includes a long list of pesticides (over 75) that meet the acute toxicity criteria that will be subject to the new restrictions. This list includes many more pesticides than just the neonicotinoid products.
In addition, for managed bees not under contracted services, or for other “unmanaged” bees, EPA’s reliance on state “Managed Pollinator Protection Plans” (MP3s) is consistent with public statements that EPA officials and line staff have made in recent months, so there appears to be few surprises in the proposal at first glance. Some states already have plans; many are under development. EPA has worked closely with state pesticide regulatory officials on development of state plans, and signaled that it expects state plans to incorporate three core ideas: public participation in developing the plan; some kind of notification scheme to alert beekeepers of insecticide applications; and a way to evaluate whether the state plan is effective in reducing insecticide exposure to bees.
Even so, what may generate the most public comment about EPA’s proposal is what it does NOT do; for example:
- The proposal does not impose a ban on neonicotinoid pesticides as some advocacy groups have sought;
- The proposal does not require EPA approval of state management plans (MP3s);
- The proposal does suggest options for registrants to seek product-specific exemptions to what is mandated; in other words, it again seeks to impose EPA regulatory actions “by letter” using a “one size fits all” approach; and
- The proposal does not offer significantly new restrictions regarding pollinators generally, but maintains a focus on contracted honeybees and commercial pollination services.
As the proposal has just been issued, stakeholders will now review the content to look for “the devil in the details” -- and develop comments to submit during the 30-day comment period EPA offers. (It would not be surprising if the comment period on such a high profile proposal is extended.)
More information concerning the Presidential Memorandum and the national strategy are available in Bergeson & Campbell, P.C.’s (B&C®) blog post on Pollinator Health Task Force Issues National Strategy to Promote the Health of Honey Bees and Other Pollinators.
By Lisa M. Campbell and James V. Aidala
On May 19 2015, President Obama’s interagency Pollinator Health Task Force -- co-chaired by the Secretary of Agriculture and the Administrator of the U.S. Environmental Protection Agency (EPA) -- issued its long awaited and anticipated “National Strategy to Promote the Health of Honey Bees and Other Pollinators,” as well as its “Pollinator Research Action Plan.” This work was done in response to President Obama’s June 20, 2014, memorandum entitled “Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators,” pursuant to which the Pollinator Health Task Force was formed and direction was given to develop a Pollinator Research Action Plan, Public Education Plan, and Public-Private Partnerships, and to identify steps the agency Task Force members will take to increase and improve pollinator habitat. All of these are addressed in the May 19, 2015, documents.
Notable issues are raised by the documents, and some of these are outlined below in the Commentary section of this blog, following the overview. A more detailed discussion will be forthcoming.
The Strategy states that it “expands and adds to actions already being undertaken by Federal departments and agencies to reverse pollinator losses and restore populations to healthy levels.” It further states that it “focuses on both immediate and long-term changes that can be made to improve the well-being of pollinator populations.”
The Strategy includes the following components:
- Pollinator Research Action Plan;
- Plans for expanding education and outreach;
- Opportunities for public-private partnerships; and
- Improving pollinator habitat.
The Strategy outlines “three overarching goals for action by Federal departments and agencies in collaboration with public and private partners”:
- Reduce honey bee colony losses during winter (overwintering mortality) to no more than 15% within 10 years. This goal is informed by the previously released Bee Informed Partnership surveys and the newly established quarterly and annual surveys by the USDA National Agricultural Statistics Service. Based on the robust data anticipated from the national, statistically-based NASS surveys of beekeepers, the Task Force will develop baseline data and additional goal metrics for winter, summer, and total annual colony loss.
- Increase the Eastern population of the monarch butterfly to 225 million butterflies occupying an area of approximately 15 acres (6 hectares) in the overwintering grounds in Mexico, through domestic/international actions and public-private partnerships, by 2020.
- Restore or enhance 7 million acres of land for pollinators over the next 5 years through Federal actions and public-private partnerships.
With regard to pesticides, the Strategy states the following “metrics” for Protecting Pollinators from Exposure to Pesticides:
- Tiered guidance for assessing the risk posed by pesticides to bees was completed in 2014 (in collaboration with Canada Pest Management Regulatory Agency (PMRA) and California Department of Pesticide Regulation (DPR)).
- Document the number and percentage of registration and registration review chemicals required to submit testing data at each Tier of the above guidance.
- Complete all honey bee exposure and effect protocols and implement the harmonized pollinator risk assessment process by the end of 2016.
- Achieve conformance with the 2015-2017 re-evaluation schedule of the nitroguanidine-substituted neonicotinoid subclass to satisfy the standard for registration under FIFRA.
- Finalize benefits assessments for imidacloprid and thiamethoxam soybean seed treatments by fall 2015.
- Provide annual updates on the number of pesticides for which the new framework for assessing risks to bees has been incorporated. Document the number of labels that contain pollinator-specific mitigation measures.
- Issue for public comment a proposed prohibition on foliar application during contracted pollinator services by December 2015.
- Issue for public comment a draft framework outlining an approach to protect monarch butterflies that balances monarch protection and weed management by summer 2015.
- Document the number of state/tribal pollinator protection plans addressing the need for improved communication between growers/applicators and beekeepers with respect to pesticide applications under development and the number of plans implemented.
- Bee mortality incident guidance was issued May 9, 2013; EPA will report annually on the number of reported mortality incidents, cumulative hive mortality, and results of inspections.
- Document the time required to evaluate proposed new Varroa control products.
- Document the number of Varroacide products available for use.
The May 19 documents are lengthy and only a few highlights are mentioned. A more detailed review of the documents will be forthcoming, but some initial comments are worthy of note. These include the fact that the Strategy is a catalog of agency activities across the federal government. Like the President’s 2014 memorandum, the emphasis is on enhancing and expanding habitat and forage opportunities for pollinators, especially honey bees. The three strategic goals are repeated often: reduce honey bee colony losses, protect monarch butterflies, and increase pollinator habitat acreage. What is more pronounced in the Strategy when compared to the 2014 directive from the President is an emphasis on the monarch butterfly. Though mentioned in the President’s memorandum, protecting the monarch butterfly is now among the three central, overarching goals of the Strategy.
The catalog of agencies involved varies widely from the obvious (EPA, U.S. Department of Agriculture (USDA), and Department of Interior) to the less obvious (Department of State (DOS) and the Federal Emergency Management Agency). The Strategy thus discusses everything from adding millions of dollars for more research by USDA to planting a pollinator-friendly garden on the roof of DOS. Much of the agenda is an extension of current programs (incentives in the Conservation Reserve Program, accelerated pesticide reviews), along with what may be some new initiatives (Department of Transportation initiatives along Interstate 35, as it is along the migration path of the monarch butterfly).
Regarding pesticides, many items addressed in the response have been anticipated or otherwise discussed by EPA staff in various settings over the last few months. EPA announced that it will impose a number of new restrictions and conditions on the application of neonic insecticides where the grower who will apply the pesticides has contracted for pollination services. This will especially apply to the almond pollination situation, but is not limited to that case. It also means that even if the person applying the pesticide is contracting for pollination services and has permission from the beekeeper to apply the pesticide outside of the new limitations, doing so may be a violation of the pertinent product label.
For products applied by growers who are not using commercial pollination, the essence of the pollinator protection requirements will be in compliance with a state management plan (known as a Pollinator Protection Plan (P3)). Some states already have plans, many are under development. EPA has signaled that it expects state plans to incorporate three core ideas: public participation in developing the plan, some kind of notification scheme to alert beekeepers of insecticide applications, and a way to evaluate whether the state plan is effective in reducing insecticide exposure to bees.
EPA states that this scheme may be applied to more insecticides than simply neonicotinoid products, and that evaluation would be part of the registration review process for other insecticides. EPA cites its recent correspondence to registrants of the neonicotinoids that no new formulations of products will be processed until more data on possible effects have been submitted and evaluated.
EPA also states that it will continue the benefits assessment of the neonicotinoid products, but has a milder tone when referring to the exercise than when it released its soybean seed treatment benefits memorandum last October. EPA now describes its rationale for doing the soybean assessment as being essentially “because some scientific publications" stated they have “little value” -- in contrast to some of the rhetoric EPA used in October effectively concluding that there is no benefit from their use.
The most novel element of the EPA response may be the description of actions to “mitigate pesticide impacts on monarch butterflies.” The document hints at field restrictions and what may be refugia-like requirements, even though these are not genetically modified organism products. To some degree, this concept presents some novel policy and regulatory issues, since it would represent attempts to regulate use of a pesticide outside the site of application of the pesticide -- and insist on maintenance of some weed species otherwise intended to be controlled. It could also portend some scheme for protection of endangered species from a pesticide’s use, although the monarch is not (yet) listed as threatened or endangered.
EPA states it will issue a draft strategy for protecting the monarch butterfly for comment in summer 2015.