Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

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.

Commentary

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 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 Lisa M. Campbell

The California Department of Pesticide Regulation (DPR) recently issued its Progress Report 2012-2014, which highlights DPR’s view of achievements under the leadership of Director Brian Leahy. Among the achievements noted are the following; others are also discussed in the report.

• Restricting sales of Second Generation Anticoagulant Rodenticides (SCAR). This action is described as having been “the catalyst for a national change, as the manufacturer agreed with U.S. EPA to phase out these products after DPR’s action.”

• Implementing surface water regulations for pyrethroids. This action is described as “an aggressive preventative measure for environmental protection starting at the first point of pesticide applications.”

• Committing more than $3 million in research for alternatives to field fumigants since 2012 and “reducing risks to the public from field fumigations,” as well as “protecting workers and the public from structural fumigations.”

• Efforts to reduce pesticide use in schools and child care centers.

• Collecting air monitoring data, regulating volatile organic compounds, as well as a number of other actions addressing environmental monitoring.

• Efforts to reevaluate neonicotinoids.

The Progress Report highlights and achievements reflect well many DPR priorities and the direction DPR is continuing to forge on a number of issues, some of which are subject to significant controversy.

 


 

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 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.
 


 
 < 1 2