By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was seeking comment on its Draft Revised Method for National Level Endangered Species Risk Assessment Process for Biological Evaluations of Pesticides (Draft Revised Method).  84 Fed. Reg. 22120.  It also announced that it would host a public meeting on June 10, 2019, in which it will present the Draft Revised Method and provide an additional opportunity for the public to provide feedback. 

The Draft Revised Method states it is intended to be “used in the evaluation of potential risks from pesticides to listed species” and that it will be “used by EPA for making effects determinations under registration review, which will also be used to inform biological opinions from the Fish and Wildlife Service and the National Marine Fisheries Service [(the Services)].”

EPA states that the Draft Revised Method document “describes proposed revisions to the interim methods used to conduct effects determinations as documented in EPA’s [biological evaluations (BE)] for federally threatened and endangered species for pesticides.”  EPA states the revisions are based on: (1) “refinements” following the method used in the first three national-level BEs for chlorpyrifos, diazinon, and malathion; (2) consideration of public comments provided through stakeholder meetings and submitted to the docket for the pilot draft BEs; (3) consideration of National Research Council (NRC) recommendations; and (4) “lessons learned during the development of the first three BEs.”

EPA states that the following are major aspects of its proposed revisions on which it is seeking comments:

• To more accurately represent where and to what extent a pesticide is likely to be applied, EPA is proposing an approach for incorporating pesticide-specific usage data into Steps 1 and 2 of the BEs.  While the pilot BEs relied on use assumptions from pesticide product labels to represent where the pilot chemicals were likely to be applied (e.g., applied to all labeled crops at maximum application rates simultaneously), the Draft Revised Method proposes to incorporate usage data (e.g., survey data, including actual application rates) in the determination.
• Based on the accuracy of the spatial data utilized and the conservative assumptions related to the action area and potential drift, EPA’s notice states that it is proposing to interpret “a <1% overlap of listed species’ ranges with potential use sites as unreliable and not representative of real exposure potential.”
• EPA is proposing an approach for introducing components of probabilistic analysis into the BE, as the “goal of the probabilistic analysis is to more fully capture and characterize the variability in the range of potential exposures and toxicological effects to listed species to better inform the biological opinion.”
• EPA is proposing a weight-of-evidence framework “to distinguish those listed species that are likely to be adversely affected (LAA) from those that are not likely to be adversely affected (NLAA), based on criteria (e.g., dietary preferences, migration patterns, extent of range potentially exposed) associated with the likelihood that an individual will be exposed and affected.”

The June 10 public meeting, which EPA states “is part of the federal government’s coordinated effort to improve the Endangered Species Act (ESA) process that is used when pesticides are federally registered,” will be held from 9:00 a.m. to 12:00 p.m. (EDT) in the lobby-level conference center of EPA’s offices at Potomac Yard South in Arlington, Virginia.  Those wishing to attend either in person or via teleconference/webinar must register by May 30, 2019.  Registration is available online.  Comments on the Draft Revised Method are due by July 1, 2019, in Docket No. EPA-HQ-OPP-2019-0185 on www.regulations.gov.

Commentary

This is the latest chapter in the long saga of coordination between ESA review by the Services and EPA registration activities.  The steps outlined in the Draft Revised Method are designed to improve the coordination of work between the agencies and represent an important step in designing a framework that might make the current situation more reliable, predictable, and efficient.  The current process has been subject to criticism on a number of fronts, with the current BE process seen as unsustainable given the amount of resources and time consumed by the first BEs. 

The goal is eventually to have the Services and EPA “play nice together” and implement a leaner and more efficient process, which is considered absolutely necessary if EPA hopes ever to complete appropriate ESA assessments on hundreds of active ingredients formulated into thousands of end use pesticide products.  Such efforts could also represent a cornerstone of the agencies’ meeting provisions in the 2018 Farm Bill (Section 10115), which includes requirements for the agencies to “… increase the accuracy and timeliness” of the ESA consultation process, as well as implement these same policies stated in the Memorandum of Agreement between EPA, the Department of the Interior, and the Department of Commerce on Establishment of an Interagency Working Group to Coordinate Endangered Species Act Consultations for Pesticide Registrations and Registration Review.

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By Lisa M. Campbell and James V. Aidala

On May 25, 2018, the U.S. Environmental Protection Agency (EPA) issued an extension of the comment period of the proposed rule entitled “Strengthening Transparency in Regulatory Science” (Science Rule) that EPA issued on April 30, 2018.  83 Fed. Reg. 24255.  The Federal Register notice states that EPA will extend the comment period from May 30, 2018, to August 16, 2018.  EPA states that it is making these changes “in response to public requests for an extension of the comment period and for a public hearing.”  It is noteworthy that the extension was issued on the heels of EPA’s receipt of letters, one submitted by eight Attorneys General and another by 20 Senators, addressing the proposal, as described below.  Comments can be filed in Docket ID No. EPA-HQ-OA-2018-0259 on www.regulations.gov. 

EPA’s notice also announces that it will be holding a public hearing for the proposed rule on July 17, 2018, from 8:00 a.m. to 8:00 p.m. (EDT) in Washington, D.C. that will provide “the public with an opportunity to present oral comments regarding [the Science Rule]”; and will “provide interested parties the opportunity to present data, views, or arguments concerning the proposal.”  The notice states that EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time.  Registration for the public hearing will be available online; registration information is available in the Federal Register notice.

EPA’s extension and its grant of requests for a public hearing follows closely in time of its receipt, on May 7, 2018, of a letter to EPA Administrator Scott Pruitt from eight Attorneys General -- those of New York, California, Delaware, Iowa, Maine, Minnesota, Pennsylvania, and the District of Columbia -- expressing their concern regarding the Science Rule.  The letter requests EPA to withdraw the proposed rule and to consult with the National Academy of Sciences (NAS).  The letter states that if EPA is unwilling to withdraw the rule, then EPA should extend the comment period by at least 150 days to “provide for appropriate consultation with the [NAS],” as “a full six-month comment period … is necessary to provide the public and other stakeholders a meaningful opportunity to evaluate the proposal and its implications for the agency’s ability to meet its obligation to protect public health and the environment under federal environmental laws.” 

On May 14, 2018, 20 Senators submitted a letter to Pruitt requesting that the comment deadline be extended, to July 30, 2018, stating that this extra time would give “stakeholders adequate time to draft and submit thorough, well-reasoned comments,” as the rule is “expected to have a significant effect on the types and number of scientific studies EPA considers during rulemaking” and “implicates patient privacy.”

It is not clear if the extension of time for public comment indicates a desire to develop a more thorough record behind whatever may emerge as the final rule or is a reaction to some of the intense opposition to the entire scheme.  “EPA Science” has been controversial and an emerging political issue for some time, but the reaction to the proposal has been intense even in comparison to many of the changes the Trump Administration has sought to impose on other EPA policies and procedures.  To some degree, if the Trump Administration hopes to change EPA’s fundamental approach to decision-making, the sooner the better for the potential to leave a lasting change in place.  Meanwhile, even from a relatively neutral perspective, the proposal is complicated as to how such new requirements would work -- what it applies to, or how some of the critical new terms would be defined (e.g., “pivotal science”), among other complex elements.  This complexity may be its ultimate undoing, or perhaps careful consideration of voluminous (and much critical) public comment will hone the proposal into something more likely to achieve its stated goals.

More information about the Science Rule is available on our blog and in our memorandum EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule.

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By Jason E. Johnston, M.S.

On May 23, 2018, the U.S. Environmental Protection Agency (EPA) held an “Environmental Modeling Public Meeting” (EMPM).  As stated in the April 12, 2018, Federal Register notice announcing the meeting, the “EMPM provides a public forum for EPA and its stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for pesticide risk assessments in a regulatory context.”  The overall theme of the EMPM was the quantitative use of surface water monitoring data. 

The morning session featured a series of presentations by representatives from EPA, the U.S. Geological Survey (USGS), and the Washington State Department of Agriculture concerning the development of a framework to use surface water monitoring data quantitatively in pesticide risk assessments.  A major focus of the presentations was the exploration and evaluation of the capabilities of the USGS recently-developed model SEAWAVE-QEX to improve the robustness of surface water monitoring datasets so that they might be used in pesticide risk assessments.  Further public presentations on the evaluation and development of the framework are scheduled at the American Chemical Society meeting to be held on August 19-23, 2018, in Boston, Massachusetts.  There are plans to hold a Scientific Advisory Panel meeting on the framework in 2019, but no exact date has been set. 

The afternoon session consisted of presentations by representatives of the registrant community.  Topics addressed included developments in the use of surface water monitoring data in quantitative risk assessment, a statistical analysis of non-targeted monitoring data at the watershed scale, the creation of a curated database of water and sediment monitoring data for synthetic pyrethroids, the use of high-resolution spatial and temporal monitoring data to parameterize watershed scale drift exposure predictions, and an evaluation of model predictability using monitoring data and refined pesticide use at the watershed level. 

Presentations from the May 23, 2018, EMPM will soon be posted to Docket No. EPA-HQ-OPP-2009-0879, accessible at www.regulations.gov.

Registrants should monitor these activities, as this effort at EPA represents a potential shift away from the current reliance exclusively on estimated water concentrations in quantitative human health and ecological risk assessments. 

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By Lynn L. Bergeson and Margaret R. Graham

On October 25, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that the U.S. Food and Drug Administration (FDA), in coordination with the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and OPP, will be holding two public meetings to discuss FDA’s Agricultural Biotechnology Education and Outreach Initiative.  The meetings will be held in Charlotte, North Carolina on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST).  EPA states that this initiative, which Congress appropriated three million dollars to fund, “calls for FDA to work with EPA and USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology, and the purpose of the meetings is “to provide the public an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.”  FDA issued a notice on these public meetings in the Federal Register on October 13, 2017.  82 Fed. Reg. 47750.  More information on the initiative and how to register for the meetings is available on FDA’s website.  Participation is available in person or by webcast. 

In the notice, FDA also invites comments and responses to the following questions specifically regarding agricultural biotechnology and biotechnology-derived food products and animal feed:

1. What are the specific topics, questions, or other information that consumers would find most useful, and why?
2. Currently, how and from where do consumers most often receive information on this subject?
3. How can FDA (in coordination with USDA) best reach consumers with science-based educational information on this subject?

Comments can be filed in Docket No. FDA-2017-N-5991 on www.regulations.gov; comments are due by November 17, 2017.

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