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.
By Lisa M. Campbell and James V. Aidala
On April 9, 2015, the California Department of Pesticide Regulation (DPR) held the first of a planned series of workshops intended to help DPR develop “regulation concepts” for possible notifications prior to field fumigations. The presentations and video from that workshop are now available on DPR’s website.
DPR’s presentation at the workshop focused on the background that it believes supports the consideration of a notification requirement, and on current methyl bromide notification regulations and fumigant labeling requirements that it believes potentially could be used as a foundation to assist in the development of a rulemaking concept for soil-applied field fumigants.
In addition, DPR considered whether the concept can be reconciled with the current label requirements as emergency preparedness and response requirements, or maintained as a separate “right-to-know” requirement. DPR recommended expanding notification to all field fumigations, including applications of chloropicrin, 1,3-dichloropropene, methyl bromide, or pesticides that generate methyl isothiocyanate.
This potential regulatory development is of significant interest to pesticide registrants in general. The application of a right-to-know model to pesticide applications, pursuant to which growers and applicators would have to notify those in a defined proximity to the planned pesticide application, would have far-reaching ramifications. DPR’s further development of this potential regulation should be monitored closely.
Of note are similar notification schemes reportedly under consideration by the U.S. Environmental Protection Agency (EPA) as part of its pollinator protection proposals. EPA staff has spoken of how one essential component of any pollinator protection program will be some kind of notification scheme for beekeepers, or at least commercial beekeepers, who have hives in the vicinity of the use area for certain pesticides. As that issue evolves, it will invite comparison with EPA’s position on other requirements for mandatory notification, where generally EPA has not supported blanket federal requirements for notification of nearby pesticide applications. This development in the pollinator area could lead to reconsideration at the federal level regarding broader advance notification requirements for specified pesticide applications.
By Lisa M. Campbell and James V. Aidala
On April 2, 2015, the U.S. Environmental Protection Agency (EPA) sent a letter to all registrants of nitroguanidine neonicotinoid pesticide products stating that “until the data on pollinator health have been received and appropriate risk assessments completed,” EPA is “unlikely to be in a position to determine that such uses would avoid ‘unreasonable adverse effects on the environment’ as required under FFIRA to support further regulatory expansion of these pesticides in outdoor settings.” EPA asks that the affected registrants withdraw or modify pending new outdoor use/expansion and/or pending nitroguanidine neonicotinoid registrations with a new outdoor use by April 30, 2015.
The letter states that the letter recipients are companies that have submitted an application for a new outdoor use and/or hold registrations for products containing imidacloprid, dinotefuran, clothianidin or thiamethoxam that have directions for outdoor application.
Affected neonicotinoid actions include:
* New Uses (including crop group expansion requests);
* Addition of New Use Patterns, such as aerial application;
* Experimental Use Permits; and
* New Special Local Needs Registrations.
The letter does not, however, preclude the approval of “me-too” products -- “products that are identical or substantially similar to existing uses.” In addition, EPA states that if a significant new pest issue should arise that may be uniquely addressed by one of these chemicals, EPA may consider whether an emergency use under FIFRA Section 18 might be appropriate. In the event that an emergency use is requested, EPA plans to assess such requests by relying on available information and risk mitigation strategies.
This new missive from EPA provides yet another example of a recent trend that many registrants believe is of concern, whereby EPA makes a broadly applicable set of regulatory decisions without an associated administrative process. With this approach, EPA summarily issues a letter to a class of registrants with immediate direct affect on their registrations with little or no room for consideration of individual facts, and with little explanation of important risk issues. In this letter, for example, EPA precludes the expansion of new uses, but yet allows the continued processing of “me-too” applications with no explanation from a risk profile of the risk difference that allows one type of product to be processed, but not the other. There are many possible scenarios where a new or expanded use of a product would not present any more risk to pollinators than the me-too product that EPA indicates will be considered.
This one-size-fits-all approach also appears to exclude consideration of any risk reduction potential of the pending applications (for example, when a pending neonic application represents a reduction in worker risk or endangered species when compared to an existing use pattern). Some applications may replace current exposure levels to organophosphate insecticides that EPA has generally sought to reduce. The potential processing of Section 18 exemptions may provide an avenue for such considerations, but the presumption that the pollinator issue a priori makes all other risk elements secondary is a tacit admission of where EPA currently evaluates the potential risk to honeybees in comparison to other possible impacts from pesticide use, including human health risks.
More information on EPA’s efforts to protect pollinators: http://www2.epa.gov/pollinator-protection.
By Lisa M. Campbell and James V. Aidala
Recently, the results of a three-year University of Maryland study assessing the potential chronic sublethal effects on whole honey bee colonies of a diet containing imidacloprid, an insecticide that belongs to the neonicotinoid class of chemicals, at 5, 20, and 100 μg/kg over multiple brood cycles have been released. The study, Assessment of Chronic Sublethal Effects of Imidacloprid on Honey Bee Colony Health, funded primarily by a Cooperative Agreement with the U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS) Bee Research Laboratory, concludes that: “chronic exposure to imidacloprid at the higher range of field doses…could cause negative impacts on honey bee colony health and reduced overwintering success, but the most likely encountered high range of field doses relevant for seed-treated crops (5 μg/kg) had negligible effects on colony health and are unlikely a sole cause of colony declines.”
This study examines a number of recent controversial issues behind the bee health discussion, including: whether pesticides have an impact when one examines exposure levels approximating actual field condition exposure levels and whether the pesticide use has a substantial impact on hive and hive survival (and not just an impact on individual bees). The study results will likely be used by others to help evaluate the meaning of many of the studies various researchers have conducted over the past three to five years that are often cited in the media. Critics of these other studies have noted the “excessive” amounts of the pesticides used in the research protocol. They have also noted that, as insecticides, the neonicotinoid products are designed to kill insects, and since bees are insects, some bee mortality can be expected if exposed to the material. The University of Maryland study sought to emulate more realistic field conditions in the study protocol. Its conclusion, that there were “negligible effects on colony health” over a three-year period, is significant.
Also fairly recently, the Congressional Research Service (CRS) issued a report on bee health and pesticides, Bee Health: the Role of Pesticides. The report states that although the report focuses on bee exposure to pesticides, this does not imply that pesticides have a higher influence on the health and wellness of bees than other identified factors. The report states: “Although pesticides have been shown to damage bee health, it is unclear whether the level of harm is sufficient to attribute pesticides as the single or as the major cause of honey bee population declines.” The report further states that there is “the possibility that bees are being negatively affected by cumulative, multiple exposures and/or the interactive effects of several of these factors.” The CRS report refers to conclusions outlined in the USDA and the U.S. Environmental Protection Agency’s (EPA) joint Report on the National Stakeholders Conference on Honey Bee Health, including that “no research conclusively points to one single cause for the large number of honey bee deaths.”
The report details several actions the federal government is taking to promote the health of honey bees and other pollinators:
* The establishment of a Pollinator Health Task Force co-chaired by USDA and EPA that will “focus federal efforts on understanding, preventing, and recovering from pollinator losses.”
* EPA’s pesticide registration review of all neonicotinoid insecticides, and EPA’s development of new pesticide labels that prohibit use of some neonicotinoid pesticide products where bees are present, including products containing imidacloprid, dinotefuran, clothianidin, thiamethoxam, tolfenpyrad, and cyantraniliprole.
* The U.S. Fish and Wildlife Service (FWS) will be phasing out the use of neonicotinoid pesticides in all of its wildlife refuges as well as the feeding of genetically engineered crops to wildlife by January 2016.
By Lynn L. Bergeson
The Environmental Law Institute will host a complimentary webinar, “Neonicotinoids and Colony Collapse Disorder: Regulating and Product Stewardship in the Face of Uncertainty,” on Tuesday, February 24, 2015, from 12:00 p.m. - 1:30 p.m. (EST). The webinar is open to the public but registration is required.
Fraught with both scientific uncertainty and the potential for significant agricultural and ecological consequences, the debate over neonicotinoid regulation is at the forefront of environmental policy discussions, raising important issues about regulation and product stewardship in the face of scientific uncertainty paired with significant risk. This webinar will address the current questions regarding neonicotinoid pesticides and their regulation, including:
■ What is the state of the science around the role neonicotinoids may play in pollinator decline?
■ What other factors may be significant causes?
■ What should be the approach of regulators and company product stewards given the scientific uncertainty?
Bergeson & Campbell, P.C.’s (B&C®) Senior Government Consultant James V. Aidala will moderate the webinar. Mr. Aidala, former Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention) is a leading expert on the policy and regulatory issues associated with the confluence of pollinators and pesticides. He writes and speaks frequently on the subject; recent works include “Presidents and Pesticides: What’s Up with the Presidential Memo on Pollinators?,” “Neonicotinoids: EPA’s New Get-Tough Measures,” and the keynote address at the 2014 Spring Board Meeting of the Association of American Pesticide Control Officials. Mr. Aidala is also a regular contributor to B&C’s Pesticide Law and Policy Blog.
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.
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.