Posted on July 26, 2019 by Lisa M. Campbell
By Lisa M. Campbell, Timothy D. Backstrom, Lisa R. Burchi, and James V. Aidala
On July 12, 2019, the U.S. Environmental Protection Agency (EPA) announced in a Decision Memorandum that it has registered new uses and restored previously registered uses for sulfoxaflor. EPA has approved the use of sulfoxaflor on alfalfa, corn, cacao, grains (millet, oats), pineapple, sorghum, teff, teosinte, tree plantations, and restored the uses on citrus cotton, cucurbits (squash, cucumbers, watermelons, some gourds), soybeans, and strawberries. EPA states that substantial data show that when sulfoxaflor is used according to the label, it poses no significant risk to human health and poses a lower risk to non-target wildlife, including pollinators, than other registered alternative products. EPA’s registration decision is available at www.regulations.gov in Docket Number EPA-HQ-OPP-2010-0889-0570.
EPA’s decision follows an opinion issued on September 10, 2015, by the U.S. Court of Appeals for the Ninth Circuit vacating EPA’s 2013 unconditional registration for the pesticide sulfoxaflor, and remanding the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies. That decision is discussed in our blog item available here. In response to that decision, EPA also issued a cancellation order that included provisions for the disposition of existing stocks of sulfoxaflor products.
After the decision of the Ninth Circuit Court of Appeals, EPA reevaluated the data and on October 14, 2016, approved sulfoxaflor end-use registrations for limited uses that did not include crops that attract bees. EPA also has been granting emergency exemptions for sulfoxaflor since 2012, with the most recent emergency exemptions granted on June 17, 2019, for the use of sulfoxaflor to control tarnished plant bugs on cotton in 12 states, and to control sugarcane aphids on sorghum in 14 states.
In the July 12, 2019, decision adding new uses, restoring previous uses, and removing certain application restrictions, EPA states an unconditional registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(5) for new uses of sulfoxaflor is backed by substantial data, including numerous pollinator studies submitted by the registrant, Dow AgroSciences (DAS). With specific regard to sulfoxaflor’s impact on bees, EPA states the following:
Since the vacatur in 2015, DAS has submitted numerous additional pollinator studies. The pollinator data requirements listed in 40 CFR 158.630 have all been submitted or waived. EPA’s risk assessment process for pollinators has evolved since those data requirements were promulgated and now EPA generally assesses risks to bees using a three-tier process based on a more robust data set as described in two guidance documents: “Guidance for Assessing the Risks of Pesticides to Bees” (USEPA 2014) and “Guidance on Exposure and Effects Testing for Assessing Risks to Bees” (USEPA 2016). For sulfoxaflor, all Tier I data have been submitted. Three additional Tier II semi-field (tunnel) studies and two colony feeding studies have been submitted. Pollen and nectar residue data have been submitted for multiple crops. The submitted data covers all of the requested use patterns. For those crops that did not have data specific to pollen and nectar residues, data was extrapolated as appropriate from other crops. All regulatory data requirements for assessing pollinators have now been addressed and the EPA has adequate data to demonstrate that there will be no unreasonable adverse effects to honey bees resulting from the expanded registration of sulfoxaflor.
EPA’s decision also removes previously imposed application restrictions:
- Removed the prohibition of use on crops grown for seed because EPA believes pollinator protection restrictions, including low use rates, will be in place regardless of whether the crop is grown for seed or for commodity harvest;
- Removed the restriction to post-bloom application for bee-attractive crops only when there is low risk or limited potential for exposure to bees;
- Removed the 12-foot buffer requirement because EPA believes the spray drift mitigation requirements on labels are adequate to limit drift; and
- Removed the 2016 restriction against tank mixing because EPA states data show that there is no additional risk when sulfoxaflor is tank mixed with other compounds.
EPA’s decision includes the following crop specific restrictions:
- Citrus: Only one application is allowed per year between 3 days before bloom and until after petal fall.
- Ornamentals: Only one application is allowed during bloom, and that bloom must not exceed a rate of 0.071 lb ai/acre.
- Pome Fruit, Stone Fruit, Tree Nuts and Pistachio: No application is allowed any time between 3 days prior to bloom and until after petal fall.
- Small Fruit Vine Climbing and Low Growing Berry, Tree Plantations: No application is allowed any time between 3 days prior to bloom and until after petal fall.
EPA found that the FIFRA standard for registration is met for the registration of sulfoxaflor on the uses approved, and that the benefits of these uses outweigh the risks, but also set specific label requirements including restrictions to minimize potential exposure to bees:
- Worker Protection: “Applicators and other handlers must wear: Long-sleeved shirt and long pants, shoes plus socks, protective eyewear” and “Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of” 24 hours (for Transform WG label) and 12 hours (for Closer SC label).
- Environmental Hazards Statement: “This product is highly toxic to bees and other pollinating insects exposed to direct treatment or to residues in/on blooming crops or weeds. Protect pollinating insects by following label directions intended to minimize drift and reduce pesticide risk to these organisms.”
- The RT25 (how long foliar residues of sulfoxaflor exhibit toxicity to honey bees): “The RT25 for this product is less than or equal to 3 hours.”
- Directions for Use: “Notifying known beekeepers within 1 mile of the treatment area 48 hours before the product is applied will allow them to take additional steps to protect their bees. Also, limiting application to times when managed bees and native pollinators are least active, e.g. 2 hours prior to sunset or when the temperature is below 50°F at the site of application will minimize risk to bees.”
This new decision by EPA may finally be the culmination of a long and convoluted process to register sulfoxaflor. The litigation that resulted in vacatur of the initial registrations began in 2013. At the time the Ninth Circuit issued its decision in 2015, vacatur was viewed by many observers as a novel and radical response to an EPA decision to register a new pesticide. Since that time, registrants and users of newly approved active ingredients have encountered more aggressive litigation in which vacatur is often cited as a possible remedy. This has created more uncertainty and concern about product availability, even after EPA approves an eagerly anticipated new product to meet a pressing pest control need. In the case of sulfoxaflor, EPA has clearly determined that the data submitted by DAS demonstrate that any risks to pollinators presented by sulfoxaflor will be less than the risks presented by currently registered insecticides sulfoxaflor is likely to replace. This determination concerning relative risk based on review of additional data should address the deficiencies in the EPA rationale found by the Court when it vacated the 2013 sulfoxaflor registrations.
Interestingly, the current EPA decision may raise a similar issue concerning the sufficiency of EPA’s rationale concerning the effects of sulfoxaflor on endangered species. EPA states the following in its Decision Memorandum:
EPA has not made an effects determination for sulfoxaflor. EPA is currently focusing most of its resources for assessing impacts to listed species on its registration review program for currently registered pesticides. EPA believes that, as a general matter, older pesticides present a greater degree of risk to listed species than most new chemistries, including sulfoxaflor, and that it is therefore environmentally preferable in most circumstances for EPA to assess the impacts of existing pesticides sooner in the process than newer pesticides that are designed to compete with more risky alternatives. EPA believes that is especially true for sulfoxaflor, where the alternatives include organophosphates, neonicotinoids and pyrethroids. As a result, EPA does not believe the environment or the public would be best served by delaying the registration of new uses for sulfoxaflor to complete consultation. Focusing the limited resources of EPA, the Fish and Wildlife Service and the National Marine Fisheries Service on completing a consultation on the effects of sulfoxaflor would by necessity come at the expense of putting more resources into evaluating – and consequently regulating, where appropriate – what EPA believes to be more toxic compounds, that, among other things, pose greater risk, to endangered species than does sulfoxaflor.
While it is clearly sensible for EPA and the Services to prioritize the limited resources available to make and to consult concerning effects determinations for endangered species by addressing existing pesticide classes that are likely to present the greatest risk before products with new chemistries that are intended to be more selective, it remains to be seen whether reviewing courts will be inclined to accept this type of rationale. In particular, it will be interesting to see whether the sufficiency of this approach to endangered species determinations becomes an issue in any future litigation regarding sulfoxaflor or other newly registered active ingredients.
Posted on August 22, 2018 by Lisa M. Campbell
By Lisa M. Campbell and Lara A. Hall, MS, RQAP-GLP
Posted on January 13, 2017 by James V. Aidala
By James V. Aidala and Margaret R. Graham
On January 12, 2017, the U.S. Environmental Protection Agency (EPA) released its Policy to Mitigate the Acute Risk to Bees from Pesticide Products (Mitigation Policy) which describes methods for addressing acute risks to bees from pesticides. EPA states that this Mitigation Policy is “more flexible and practical than the proposed policy” that was issued on May 29, 2015, and it has “made modifications to its approach with the goal of better targeting compounds that pose an acute risk, and with the goal of reducing potential impact of this effort on growers.” EPA states that it will use its Tier 1 acute risk assessment to, in part, determine the products that trigger concerns about pollinator risk that the label restrictions are intended to address. EPA will begin implementing this Policy in 2017 by sending letters to registrants describing steps that must be taken to incorporate the new labeling. More information on the Mitigation Policy, including its supporting documents, and EPA’s response to comments submitted on the proposed policy, is available on www.regulations.gov under Docket ID EPA-HQ-OPP-2014-0818.
Also on January 12, 2017, EPA published preliminary pollinator-only risk assessments for the neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, and an update to its preliminary risk assessment for imidacloprid, published in January 2016. EPA states that the preliminary assessments for clothianidin, thiamethoxam, and dinotefuran are similar to the preliminary pollinator assessment for imidacloprid, in that they showed that “most approved uses do not pose significant risks to bee colonies,” but “spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.” As for the updated imidacloprid assessment, EPA states that is looked at potential risks to aquatic species, and identified some risks for aquatic insects. Interested parties will have 60 days to comment on the preliminary risk assessments after notice is published in the Federal Register. In terms of comments, EPA states that it is especially interested in getting input from stakeholders “on the new method for assessing potential exposure and risk through pollen and nectar.” Links to risk assessment dockets for each individual insecticide are available on EPA’s website under Schedule for Review of Neonicotinoid Pesticides. EPA states it is hopes to release the final neonicotinoid risk assessments by mid-2018.
The revised Mitigation Policy has been long in coming since it was first released over eighteen months ago. The delay in revising its approach reflects the complexity of the comments submitted, and EPA’s deliberateness in more finely crafting its policies, given the passage of time and other considerations. This revised policy contains more flexibility and explicit discussion of the need for exceptions to blanket requirements in response to some of the comments received on the earlier proposal. There remains significant public and regulator concern about the possible impacts on pollinators from pesticide use, however, there is currently less of a manic tone to EPA’s statements and actions.
For example, when discussing how EPA will approach changing the labels of the affected universe of pesticide products, there is a much less onerous tone and no specific deadlines for registrants to submit revised labels “or else.” (The 2013 directives to registrants included demands for thousands of revised labels to be submitted within six weeks “or else” -- EPA would take “appropriate action” under FIFRA.) EPA reminds us all that it retains authority to impose these new requirements broadly, a statement that will strike some as regulatory overreach, but the tone and approach is more in line with past EPA “guidance” about how it will approach a new or revised regulatory concern.
Similar to what EPA previously concluded about imidacloprid, where that assessment concluded that the most controversial use -- corn seed treatments -- did not indicate a risk concern, EPA did include in its summary about the other three neonicotinoid pesticides that:
- 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.
This might unfairly be summarized as: after years of regulatory analysis EPA has concluded that if insecticides come into direct contact with insects, there is likely to be a risk to the exposed insect.
This conclusion would be too simplistic since EPA and other regulatory bodies have expressed concern about what unintended exposures to insecticides might cause, and more generally the possibility of colony level impacts on honeybee and other pollinator populations from pesticide use. Some critics will continue to insist that EPA broaden its regulatory approach to more than just pesticides used for crops under contracted pollinator services. The broader issue of pesticide drift and possible impacts on non-target species will continue to be a concern for all pesticides.
Perhaps the more deliberate consideration of needed data generation and assessment that seems to be the current approach will allow both more refined regulatory controls if needed, and a reduction in the sometimes hot rhetoric which has accompanied the pollinator issues.
Lastly, although this revised Mitigation Policy and the three new preliminary assessments are not unexpected next steps as part of the ongoing registration review program for pesticides, given their very late release -- less than ten days before the arrival of a new Administration -- some might question whether this is part of the “midnight regulations” pushing the political agenda of the outgoing Administration. The new leadership may revise what has been released, and may come to different conclusions about any needed restrictions. That said, the issue of whether certain pesticides are having a dangerous impact on honeybee populations will continue to be a concern for regulators both in the U.S. and globally.
Posted on September 14, 2015 by Lisa M. Campbell
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.
Posted on May 29, 2015 by Lisa M. Campbell
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.
Posted on May 19, 2015 by Lisa M. Campbell
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.
Posted on January 23, 2015 by Lisa M. Campbell
By Timothy D. Backstrom, Lisa M. Campbell, and James V. Aidala
On January 21, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is registering a new insecticide, flupyradifurone, which EPA claims is “safer for bees” and will be “an alternative to more toxic products including pyrethroid, neonicotinoid, organophosphate and avermectin insecticides.” EPA has been under increasing pressure to take action to mitigate a decline in the viability of honeybee colonies known as colony collapse disorder or CCD. The neonicotinoid class of insecticides has been a subject of particular regulatory scrutiny, based on assertions that pesticides in this group are particularly toxic to pollinators. EPA has been reluctant to single out pesticide use as the dominant cause of CCD, and has suggested that habitat loss, infections with the varoa mite, and exposure to other pathogens are likely to be contributing factors as well.
In early 2013, the European Food Safety Authority released a risk assessment indicating that three neonicotinoids, clothianidin, imidacloprid, and thiamethoxam, pose an acute risk to pollinators, which led subsequently to a two-year suspension of the registrations for these three neonicotinoids in the European Union. Later that year, EPA informed registrants that it would require new labeling for neonicotinoids to mitigate risks to pollinators. In June 2014, President Obama issued a memorandum creating a federal task force to promote the health of honeybees and other pollinators, and directed EPA to assess the effects of pesticides, “including neonicotinoids,” on pollinator health.
Neonicotinoids have become more popular in large measure because of restrictions on organophosphate use that were intended to protect applicators and to reduce potential dietary risks from treated commodities. Although EPA has not expressly determined its view regarding how much neonicotinoids are contributing to CCD, EPA has been under pressure to take decisive action to address the risk to pollinators. By characterizing a newly registered insecticide primarily in terms of the risk that it poses to bees, EPA appears to be suggesting that alternatives to the neonicotinoids will become an important part of the regulatory response to CCD.
Posted on December 09, 2014 by editor
By James V. Aidala
On June 20, 2014, the White House issued a “Presidential Memorandum -- Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators.” The strategy is directed to all federal agencies and is designed to “expand Federal efforts and take new steps to reverse pollinator losses and help restore populations to healthy levels.” The text of the memorandum lists a number of goals and comments on pollinator health, and has a focus on setting up a government-wide task force, along with directives about research into the factors affecting pollinator health and suggestions to improve pollinator habitat. The role and possible impacts of pesticides on pollinators are mentioned, but are not prominent. Specifically, the memorandum mentions that one of the strategies to consider is to include “identification of existing and new methods and best practices to reduce pollinator exposure to pesticides, and new cost-effective ways to control bee pests and diseases.” Finally, it directs the new federal task force to report back to President Obama in six months.
Six months from the date of the memorandum is drawing near (December 20) -- so now, where are we? In summary, remarks by those leading the task force (staff from the U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA)) report that the response to the memorandum is now planned to be sent to the White House in draft form around the due date (the Holidays probably allowing for some schedule wiggle room), and that the public will be allowed to comment on the suggestions. That might mean a public release of the draft plan sometime in early Spring 2015, a date that coincidentally could dovetail with the beginning of the use season for commercial honeybee services (the almond crop in California begins to need bees around February depending on weather, temperature, and related considerations). No public release of the strategy is expected for at least 90 days or more. Private conversations and trade press reports indicate some slowness in convening and coordinating such a large and diverse group of agencies, as some agencies appear reluctant to participate in significant ways or otherwise are not sure exactly how or what their contribution to the effort should be (that, of course, is one of the main points of the exercise).
EPA and USDA have hosted two “listening sessions” on the memo -- on November 12 and 17 -- in Washington, D.C. Little detail was presented by the hosts; mostly it was open microphone with no advanced sign-up, so participants gave remarks in person or by phone. EPA and USDA did tell the audience that they would receive written comments on the memorandum if submitted by November 24. All of this public input will apparently go into the process of formulating the strategy. Many commenters, in fact most of those who spoke, had a “for or against” opinion about pesticide use and any possible impact on pollinators. Very few spoke of habitat issues or the research issues, even though those concerns dominate the text of the President’s memorandum.
Posted on July 09, 2014 by Lisa M. Campbell
By Lisa M. Campbell
On July 7, 2014, the Natural Resources Defense Council (NRDC) filed with the U.S. Environmental Protection Agency (EPA) a petition requesting that EPA commence a Special Review for the neonicotinoid pesticides, including six specific active ingredients (dinotefuran, acetamiprid, clothianidin, thiacloprid, imidacloprid, and thiamethoxam), based on the risk that NRDC believes this class of compounds poses to honey bees and native bees. In the petition, NRDC alleges that neonicotinoids “may suppress bee immunity, disrupt brood cycles, impair foraging behavior by interfering with memory and learning, and cause disorientation, preventing bees from finding their way back to the hive.” By submitting this petition, NRDC effectively asks that EPA expedite the evaluation of the effect of this class of active ingredients on pollinators that EPA already intends to undertake as part of the Registration Review process required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(g), 7 U.S.C. § 136a(g). A copy of the petition is available online.
Posted on June 23, 2014 by editor
By James V. Aidala
On June 20, 2014, President Obama issued a Presidential memorandum entitled “Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators.” The memorandum creates a Pollinator Health Task Force, which will be co-chaired by the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA). The Task Force will develop a National Pollinator Health Strategy, which includes a Pollinator Research Action Plan, Public Education Plan, and public-private partnerships. In addition, Task Force members will take steps to increase and improve pollinator habitat. The Presidential memorandum is available online.
Various stakeholders anticipated some kind of Presidential activity during Pollinator Week, and these pronouncements establish some new initiatives that are not likely too controversial among the pesticide registrant community. Nevertheless, their issuance and activities that will take place as a result of them bear close attention and monitoring from the registrant community, particularly as advocacy groups may see the actions as too little.
Under the Presidential memorandum, the Pollinator Health Task Force has 180 days to develop a National Pollinator Health Strategy, which shall include explicit goals, milestones, and metrics to measure progress.