Posted on December 08, 2022 by Lisa M. Campbell
By Lisa R. Burchi, James V. Aidala, and Dennis R. Deziel
On November 29, 2022, the U.S. Environmental Protection Agency (EPA) announced proposed new mitigation measures for 11 rodenticides, including measures to reduce potential exposures to three federally listed endangered and threatened species and one critical habitat. The mitigation measures are part of EPA’s goals outlined in its April 2022 Endangered Species Act (ESA) Workplan and one of the ESA pilots described in its November 2022 update.
Comments on the proposed interim decisions (PIDs) are due on or before February 13, 2023, in the following pesticide registration review dockets:
- Brodifacoum, EPA-HQ-OPP-2015-0767;
- Bromadiolone, EPA-HQ-OPP-2015-0768;
- Bromethalin, EPA-HQ-OPP-2016-0077;
- Chlorophacinone, EPA-HQ-OPP-2015-0778;
- Cholecalciferol, EPA-HQ-OPP-2016-0139;
- Difenacoum, EPA-HQ-OPP-2015-0769;
- Difethialone, EPA-HQ-OPP-2015-0770;
- Diphacinone (and its sodium salt), EPA-HQ-OPP-2015-0777;
- Strychnine, EPA-HQ-OPP-2015-0754;
- Warfarin (and its sodium salt), EPA-HQ-OPP-2015-0481; and
- Zinc Phosphide, EPA-HQ-OPP-2016-0140.
As background, in 2008, EPA issued a risk mitigation decision (RMD) for 10 rodenticides that set forth mitigation measures to reduce risks to human health and non-target organisms, including implementing minimum packaging size requirements for products on the consumer market (must be in packages one pound or less), prohibiting products intended for general consumers (i.e., homeowners or residential consumers) from containing second-generation anticoagulant rodenticides (SGAR), and requiring tamper- and weather-resistant bait stations for outdoor, above-ground placements where children, pets, and wildlife may be present. The 2009 RMD represented EPA’s final decision on the reregistration eligibility of rodenticide products at that time and constituted EPA’s final action.
The PIDs cover three first-generation anticoagulant rodenticides (FGAR), four SGARs, and four non-anticoagulant rodenticides. Strychnine (the 11th rodenticide) was not part of the 2008 RMD but is now included as part of EPA’s registration review of the rodenticide group.
The PIDs propose additional mitigation measures based on findings in the 2020 draft human health and ecological risk assessments (DRA) and comments submitted on the DRA. According to EPA, these measures are intended to reduce exposure to non-target organisms. Proposed measures include requiring bait to be placed in tamper-resistant bait boxes to ensure it is contained and requiring users to collect carcasses of rodents that may have consumed rodenticides to prevent further exposures to non-target organisms that could consume the carcasses. In addition, in its PIDs EPA proposes that all products, excluding those registered solely for use by homeowners, include label language directing users to access the web-based Bulletins Live! Two and follow the measures contained in any Endangered Species Protection Bulletin(s) for the area in which the user is applying the product.
EPA states the ESA workplan describes how it is developing early mitigation for a subset of species where EPA predicts a likelihood of a jeopardy or adverse modification finding for one or more of the registration review pilot pesticides if mitigation is not undertaken. One of these pilots is for rodenticides, which will focus on addressing effects to mammals and birds that consume rodenticide bait (primary consumers) and to birds, mammals, and reptiles that consume primary consumers (secondary consumers).
According to EPA, as part of its registration review ESA pilot for the rodenticides, EPA evaluated their potential effects on individuals and populations of Stephens’ kangaroo rat, Attwater’s prairie chicken, and the California condor and its designated critical habitat. EPA states it chose these three listed species because they represent species that may be affected by rodenticides through different routes of exposure (e.g., primary consumption by Stephens’ kangaroo rat and Attwater’s prairie chicken, secondary consumption by California condor). EPA’s draft evaluation determined that rodenticide use is “likely to adversely affect” these three species but predicted the proposed mitigations will protect them from likely “jeopardy” (i.e., potential impacts to the survival of listed species) and “adverse modification” of critical habitat. A “likely to adversely affect” determination means EPA reasonably expects that at least one individual animal of any of the three species may be exposed to one or more of the rodenticides at a sufficient level to have an adverse effect. While EPA has made predictions about the likelihood of jeopardy and adverse modification, the U.S. Fish and Wildlife Service (USFWS) is responsible for making the actual jeopardy/adverse modification findings for these species and has the sole authority to do so.
To focus the mitigations where they are most needed while retaining options for rodenticide users, EPA states the proposed mitigation measures for the three listed species would be targeted in specific geographic areas most relevant to the species. The PIDs include proposed mitigation measures to be included on the Bulletins Live! Two website for the species and the critical habitat of the California Condor. The draft evaluation for the three species and one critical habitat and associated mitigation measures are pilots for other listed species that may be similarly exposed and affected by rodenticides. In developing and applying mitigation measures for these species, EPA stated that it recognized that not all rodenticides have the same effects.
In addition to describing the pilot and the mitigation measures for the selected species, the PIDs also describe EPA’s plans for expanding those mitigation measures to the other approximately 90 listed species potentially affected by rodenticides. When this plan is issued in final, it will be known as the Rodenticide Strategy that EPA described in its November 2022 update to its ESA Workplan.
EPA also announced it intends to make effects determinations for all listed species available in a draft biological evaluation (BE), which EPA anticipates making available for public comment in November 2023. The BEs will contain EPA’s draft analysis of the potential effects of the rodenticides on listed species and their designated critical habitats and will identify mitigation measures for these species and critical habitats to avoid or minimize exposure from the rodenticides. EPA expects to complete the final BE for the rodenticides in November 2024.
If EPA’s final BE continues to find that rodenticide use is likely to affect adversely listed species or adversely modify their critical habitats, then EPA will initiate formal consultation and share its findings with the USFWS, which in turn can use the information in EPA’s BE to inform its biological opinions. If the USFWS determines in its final biological opinions that additional mitigations are necessary to address any jeopardy or adverse modification determination, or to address any incidental take, then EPA will work to ensure that any necessary registration or labeling changes are made.
Additional information on EPA’s rodent control pesticide safety review is available here.
The proposed interim decisions cover the full “rodenticide cluster” -- seven anticoagulant rodenticides and four non-anticoagulant rodenticides. Strychnine (the 11th rodenticide) was not part of the 2008 Risk Management Decision but is now included as part of EPA’s registration review of the rodenticide group.
EPA has determined that rodenticide use is “likely to adversely affect” three representative species but also predicts that the proposed mitigations will protect them from likely “jeopardy.” Note that while EPA has made predictions about the likelihood of jeopardy and adverse modification, the USFWS is responsible for making the actual jeopardy/adverse modification findings for these species and has the sole authority to do so. As stated above, EPA intends to make effects determinations for all listed species (about 90 species) available in a draft BE in November 2023, and EPA expects to complete the final BE for the rodenticides in November 2024. In short, this November 2022 action represents a mid-point, not a starting point or endpoint, for action on rodenticides, and EPA’s approach on addressing endangered species will be a good indicator of how well the ESA Workplan process and approach are working over the coming months.
Requiring bait to be placed in tamper-resistant bait boxes to ensure it is contained is a common, straightforward measure and generally follows current practices. Requiring users to collect carcasses of rodents that may have consumed rodenticides can be difficult to measure compliance and to enforce and also raises different public health concerns; we expect this approach to be debated further. In addition, the proposed interim decisions would require that all products -- excluding those registered solely for use by homeowners -- include label language directing users to access the web-based Bulletins Live! Two and follow the measures contained in any Endangered Species Protection Bulletin(s) for the area in which the user is applying the product. Understanding this process and the map for the user’s region specifically will be a process that applicators adjust to over time, but the quality and clarity of EPA’s assessments and maps will be important and need improvements. The Bulletins Live! Two system will need continuous investment and improvements to be effective, and linking all of these interactive processes (e.g., rodenticide strategy, ESA Workplan, web-based mapping and announcement systems) could prove cumbersome over time if not managed closely.
Overall, this continues the pesticide program’s march through the thicket of ESA decisions that must be made over the next many years. EPA is using its revised approach as outlined in earlier announcements regarding how it will attempt to comply with ESA as part of the registration and registration review process. The positive news is that EPA is starting to make progress on ESA compliance, which has long been discussed as part of program planning and in response to numerous ESA lawsuits over the past many years. Less clear is how EPA’s requirements will be able to be implemented and/or enforced, and how attempts to implement or comply with label changes might result in controversies among applicators and users of the affected pesticide products. The feasibility and acceptability of some label requirements are among the open questions about EPA’s new approaches to address this long-standing issue.
Posted on November 23, 2022 by Lisa M. Campbell
By James V. Aidala, Dennis R. Deziel and Heather F. Collins, M.S.
On November 16, 2022, the U.S. Environmental Protection Agency (EPA) announced it released an Endangered Species Act (ESA) Workplan Update (Workplan Update) that outlines major steps to increase protections for wildlife and regulatory certainty for pesticide users. The Workplan Update details how EPA will pursue protections for nontarget species, including federally listed endangered and threatened (i.e., listed) species, earlier in the process for pesticide registration review and other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. According to EPA, these early protections will help EPA comply with the ESA, thus reducing its legal vulnerability, providing farmers with more predictable access to pesticides, and simplifying the ESA-FIFRA process that, left unchanged, creates both significant litigation risk and a workload far exceeding what EPA has the resources to handle.
EPA states this update is a follow-up to EPA’s April 2022 ESA Workplan that addresses the complexity of meeting its ESA obligations for thousands of FIFRA actions annually. The ESA Workplan prioritizes certain FIFRA actions for ESA compliance, outlines how EPA will pursue early mitigation for listed species under FIFRA, and describes directions for expediting and simplifying the current pesticide consultation process.
As part of registering new pesticides or reevaluating pesticides during registration review, EPA has a responsibility under the ESA to ensure certain pesticide registrations do not jeopardize the continued existence of listed species or adversely modify their designated critical habitats. EPA states that it has seen in the past few decades an increase in litigation due to EPA’s failure to meet its ESA obligations when taking FIFRA actions. Over the next six years, existing court-enforceable deadlines will require EPA to complete ESA reviews for 18 pesticides -- the most EPA estimates it can handle during this period based on its current capacity and processes. Ongoing litigation and settlement discussions for other lawsuits cover dozens of additional pesticides and will likely fill the EPA’s ESA workload well beyond 2030. According to EPA, if its ESA efforts continue at this pace, a future court may decide to curtail drastically pesticide use until EPA meets its obligations. EPA believes this situation would be unsustainable and legally tenuous and provide inadequate protection for listed species and create regulatory uncertainty for farmers and other pesticide users.
The Workplan Update is EPA’s first update to the ESA Workplan and covers four main goals:
- Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.
- Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for many future conventional and biological pesticide registration and registration review actions to protect nontarget species. For each FIFRA action, EPA will consider this menu and propose, based on the risks and benefits of the particular pesticide, which specific measures to include on the pesticide label.
- Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture. Where needed, EPA may develop these measures to complement the generic FIFRA ecological mitigation described above.
- Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.
The first strategy described in EPA’s ESA Workplan is to “meet ESA obligations for FIFRA actions.” EPA states as part of its work to execute this strategy, it has identified a menu of Interim Ecological Mitigation measures it will use as a starting point to address pesticide risks to nontarget species during registration and registration review.
The menu of Interim Ecological Mitigation will include measures to reduce pesticide spray drift and pesticide runoff and will be considered as part of EPA’s upcoming proposed interim registration review decisions. While EPA intends for this set of Interim Ecological Mitigation measures to apply widely to many pesticides, EPA will consider the menu of options for any given pesticide depending on the level of risk that it poses to species and the exposure route.
EPA anticipates that this approach will more efficiently establish protections for nontarget species, including listed species, and standardize the protections across similar pesticides, in contrast to identifying mitigation measures pesticide by pesticide or species by species, as EPA has typically done in the past.
EPA states it will also work with registrants to add language on pesticide incident reporting, advisory language to protect insect pollinators, and language to most outdoor-use pesticide labels that directs users to reference Bulletins Live! Two, a website where pesticide users can find endangered species protection bulletins. These bulletins describe geographically specific use limitations to protect threatened and endangered species and their designated critical habitat.
EPA expects that once consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service is completed for any given outdoor-use pesticide, endangered species protection bulletins may be necessary for at least one listed species.
EPA also expects that working with registrants proactively to add the reference to Bulletins Live! Two to pesticide labels in advance of consultation will ultimately save EPA, state partners, and registrants time and resources by minimizing the number of amendments to labels.
The ESA Workplan Update also describes initiatives that, according to EPA, will help it and other federal agencies improve approaches to mitigation under the ESA and improve the interagency consultation process outlined in the ESA Workplan. These initiatives include EPA’s work to identify ESA mitigation measures for pilot species, incorporate early ESA mitigation measures for groups of pesticides (e.g., herbicides), and develop region-specific ESA mitigations.
Comments on the proposed set of interim mitigation measures and the proposed revisions to label language included in the Workplan Update appendix are due on or before January 30, 2023. Comments can be submitted at EPA-HQ-OPP-2022-0908.
This next phase of the ESA Workplan provides more detail about how EPA plans to impose various mitigation measures to meet its ESA obligations when registering a pesticide. The most favorable view of what EPA has presented is that it continues the march toward ESA compliance, which is long overdue, and provides more detail about the kinds of mitigation approaches it will place on pesticide labels to meet ESA requirements. The less favorable view here is that EPA has outlined a number of “off the shelf” mitigation options (buffers to reduce pesticide drift and water runoff), and EPA might impose such conditions in many instances where more careful analysis of usage data and site- or use-specific considerations might lessen the areas where such mitigation measures are needed.
EPA has stated previously as part of its earlier Workplan document, issued in April 2022, that using the present approaches EPA would complete only 5 percent of the ESA required reviews in about 18 years -- implying that the current approach would take about 360 years to complete. This next iteration of the Workplan, describing “early mitigation” strategies, is designed to reduce this unacceptable timeframe (360 years), but is likely to lead to fears among some stakeholders that in a “rush” to complete this work, EPA will make overly conservative label restrictions and reduce availability of the pesticide without increased species protections. Such concerns raise immediate ancillary concerns about stakeholder involvement in decision-making, compliance with what might be complicated label requirements, and enforcement of what is already typically a long list of label requirements for many current products. An example of such issues: one mitigation option example discussed is “do not use when rain is expected in the next 48 hours” -- which could raise issues concerning what or how compliance might be proven or enforced.
Again, to be sure, this next document about how EPA plans to make significant progress in meeting its ESA obligations continues the effort to convince courts that it is meeting its ESA obligations. As such, it represents a large step forward where in the past EPA was left with little progress or plans to present in court as part of litigation over ESA compliance. As it continues to reveal its plans and options, however, stakeholders will need to follow closely and consider the possible impacts of the Workplan and the resulting label proposals to follow.
Posted on December 10, 2020 by Lisa M. Campbell
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On December 7, 2020, the U.S. Environmental Protection Agency (EPA) issued for comment the Proposed Interim Decision (PID) for chlorpyrifos. 85 Fed. Reg. 78849. EPA announced it is proposing new risk mitigation measures to address potential human and environmental risks identified in EPA’s September 2020 draft risk assessments. The PID proposes the following measures:
- Label amendments limiting application to address potential drinking water risks of concern.
- Additional personal protection equipment and application restrictions to address potential occupational handler risks of concern.
- Spray drift mitigation, in combination with the use limitations and application restrictions identified to address drinking water and occupational risks, to reduce exposure to non-target organisms.
EPA states that the PID presents proposed mitigation with the 10-fold (10x) Food Quality Protection Act (FQPA) safety factor, reflecting the uncertainties around doses that may cause pre- and post-natal neurodevelopmental effects. Under FQPA, EPA evaluates new and existing pesticides to ensure they can be used with a reasonable certainty of no harm to infants, children, and adults. EPA is required to consider the special susceptibility of children to pesticides by using an additional 10x safety factor unless adequate data are available to support a different factor. EPA additionally included a FQPA factor of 1x to reflect the range of potential risk estimates of chlorpyrifos, as illustrated in the September 2020 draft risk assessments.
Comments on both the September 2020 draft risk assessments and the PID are due on or before February 5, 2021. EPA states that by holding the comment period for both actions at the same time, the public has access to more information and can provide more informed, robust comments. Comments can be submitted at EPA-HQ-OPP-2008-0850.
EPA announced that it will also consider the input and recommendations from the September 2020 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting once it releases its report in December 2020. Depending on the SAP’s conclusions, EPA may further revise the human health risk assessment.
The inclusion of both 1x and 10x calculations for the appropriate FQPA safety factor is unusual. EPA states the final decision on the appropriate FQPA safety factor is partly dependent on any recommendations expected from the SAP meeting, which reviewed the “use of new approach methodologies (NAMs) to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment.” This is part of a larger and longer evaluation of whether test methods that avoid using test animals can reliably substitute for current test guideline requirements, that is, whether it is appropriate to rely on in vitro test protocols to substitute for current in vivo testing protocols.
EPA’s articulation at this point in time of mitigation needed if the FQPA 10x safety factor is retained may indicate a prediction about the SAP’s likely recommendations. It will be important to monitor developments on this issue closely.
Posted on December 24, 2019 by editor
By Timothy D. Backstrom and James V. Aidala
On December 18, 2019, the Office of Pesticide Programs (OPP) of the U.S. Environmental Protection Agency (EPA) issued for comment a Proposed Interim Decision (PID) in the ongoing registration review process for each of the three registered triazine herbicides: atrazine, propazine, and simazine. EPA will allow 60 days for comment on each of these triazine PIDs, but the specific comment deadline will only be established after EPA has published notice concerning the proposed interim decisions in the Federal Register. EPA can utilize an “interim registration review decision” under 40 C.F.R. Section 155.56 whenever it is not yet ready to complete the registration review process, but EPA has nonetheless completed sufficient review to determine that new or interim risk mitigation measures are needed or that additional data or information should be submitted to complete the review. For each of the three triazine herbicides, EPA is proposing to impose specific risk mitigation measures for particular registered uses to mitigate potential health and environmental risks. For each triazine herbicide, EPA is not yet ready to make a final registration review decision because EPA has not made findings in the Endocrine Disruptor Screening Program (EDSP) or an effects determination under the Endangered Species Act (ESA). Several key factors that will affect the final registration review decision for each of the triazine herbicides are discussed below.
Common Factors for Triazine Risk Assessment
There are several common factors to consider with regard to the triazines risk assessment. These include:
- Atrazine, propazine, and simazine are all included in the chlorotriazine chemical class. EPA has determined that these three herbicides, along with three specific chlorinated metabolites, share a common mechanism of toxicity, so human health risks from all of these substances are being assessed by EPA together through one cumulative triazine risk assessment. The contribution of each product to aggregate human risk differs because of somewhat dissimilar use patterns. The combining of risks resulting from use of each triazine means, however, that it may be necessary for EPA to coordinate the ultimate registration review decisions for the three active ingredients.
- As part of the ecological risk assessment for each triazine herbicide, EPA plans to make an effects determination for potentially vulnerable species under the ESA, which in turn will determine whether it is necessary for EPA to consult with the Fish and Wildlife Service or the National Marine Fisheries Service (the Services) concerning potential impacts of each active ingredient and relevant metabolites on endangered or threatened species. Atrazine, propazine, and simazine are all included in a stipulated settlement between the parties in Center for Biological Diversity et al. v. EPA et al. No. 3:11 cv 0293 (N.D. Cal.), and EPA agreed in that stipulated settlement to set August 14, 2021, as the deadline for EPA to make a nationwide effects determination for each active ingredient, and to request any required consultation with the Services, under ESA Section 7(a)(2).
- EPA states that the predominant human health effect of concern for all three of the triazine herbicides and their chlorinated metabolites is potential suppression of the luteinizing hormone (LH) surge, which is considered to be both a neuroendocrine and a developmental effect. Atrazine and simazine were both included on List 1 for screening testing under the EDSP required by the Food Quality Protection Act (FQPA) amendments. All of the required Tier 1 screening assays for each of these substances are complete and have been evaluated by EPA, but EPA has not yet made human health or environmental findings under the EDSP. The EDSP screening testing has not been completed yet for propazine.
Risk Mitigation Measures
Each PID proposes specific risk mitigation measures intended to address potential human and environmental risks identified by the EPA risk assessments.
For atrazine, the PID includes the following measures to mitigate aggregate human risk:
- Reduce the permissible application rates for use of granular and liquid formulations on residential turf.
- Require additional personal protective equipment (PPE) and engineering controls for certain uses.
- Restrict aerial applications to liquid formulations only.
- Limit backpack sprayer applications to landscape turf to spot treatment only.
- Prohibit pressurized handgun application to certain commodities.
To mitigate ecological risks, the atrazine PID proposes to require various spray drift reduction measures, to add a non-target advisory statement to labeling, and to adopt a nationwide stewardship program.
For propazine, the PID proposes to cancel the greenhouse use to mitigate aggregate human risk. Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.
For simazine, the PID includes the following measures to mitigate aggregate human risk:
- Cancel simazine use on residential turf.
- Require additional PPE and engineering controls for certain uses.
- Limit pressurized handgun applications to certain commodities to spot treatment only.
Ecological risks would be mitigated by proposing to require various spray drift reduction measures and by adding a non-target advisory statement to labeling.
In each of the PIDs for the triazine herbicides, EPA has focused its efforts on adopting mitigation measures which should be efficacious in reducing human and ecological risks without materially impairing the availability of the products in question for key agricultural uses. In some instances, the PID documents explicitly state that the product registrants have agreed to proposed changes. An EPA Pesticide Program Update dated December 19, 2019, that discusses the interim decision for atrazine includes statements of support from several grower groups.
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.