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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.

Commentary

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.


 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by Pesticide Action Network North America and Natural Resources Defense Council in 2007. That petition requested that EPA cancel all registrations and revoke all tolerances for the insecticide chlorpyrifos. An order granting a writ of mandamus is unusual, and indicates that the Court is impatient about what it perceives to be the slow pace of review by the U.S. Environmental Protection Agency (EPA). The petitioners previously sought such a writ in 2012, and the Court denied that request without prejudice in 2013. EPA took action in 2012 that addressed seven out of the ten issues originally raised by the petitioners, and the Court found in 2013 that the time taken by EPA to address the petition was “not unreasonable in light of the complexity of the issue.” On March 26, 2015, EPA wrote to the petitioners stating that it intends to deny their petition to cancel registrations and revoke tolerances for chlorpyrifos. EPA bases this anticipated decision on a new human health risk assessment incorporating a physiologically based pharmacokinetic-pharmacodynamic (PBPK-PD) model that allows EPA to estimate human risk directly rather than extrapolating from animal data. Based on this model, EPA determined that label changes are needed to mitigate certain occupational exposures and localized drinking water exposure, and has requested comment on these findings.

EPA counsel represented during oral argument in the case that EPA could complete its review of the comments and take action on the petition by mid-September 2015. In response, the Court has issued an order directing EPA either to submit a status report by June 30, 2015, stating whether EPA intends to finalize its preliminary denial, or whether EPA has decided instead to grant the petition in whole or in part. If the petition will be denied, EPA must issue the final denial decision by September 15, 2015.

Commentary

The schedule imposed by the Court order is demanding, but it is likely that EPA will make every effort to meet it. The Court did not require EPA to respond to all of the comments on the risk assessment, or to determine what mitigation measures will ultimately be required, by the September deadline. Although EPA would normally prefer to complete all related tasks and to compile a comprehensive administrative record before issuing the final decision denying the petition to cancel chlorpyrifos, that would be very challenging to do in this instance. The comment period for the current risk assessment closed on April 30, 2015, and EPA must evaluate and respond to detailed comments on a complex assessment, one which has some important issues subject to serious dispute by the affected registrants. For example, Dow Agrosciences LLC submitted a 130 page set of comments on April 29, 2015, in addition to comments received from the general public, users of the pesticide, and other interested parties. If EPA determines it will proceed with its stated intent to deny the petition to cancel, this action may precede the mitigation measures that EPA imposes based on the chlorpyrifos risk assessment and the comments on that assessment. Nevertheless, because the petitioners are likely to challenge the denial decision as well, EPA will need to prepare an adequate explanation of the reasons for the denial and to expedite the related administrative actions to the extent that is practicable.