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EPA Releases Proposed Interim Registration Review Decision for Glyphosate; ATSDR Announces Availability of Draft Toxicological Profile For Glyphosate

On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms.  84 Fed. Reg. 19782.  In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential risk to terrestrial and aquatic plants from off-site spray drift, consistent with glyphosate’s use as a herbicide.”  Even with these potential risks, the PID states that “EPA concludes that the benefits outweigh the potential ecological risks when glyphosate is used according to label directions” and proposes certain risk mitigation strategies including:

  • “To reduce off-site spray drift to non-target organisms, the EPA is proposing certain spray drift management measures” with specific spray drift mitigation language to be included on all glyphosate product labels for products applied by liquid spray application;

  • “To preserve glyphosate as a viable tool for growers and combat weed resistance, the EPA is … proposing that herbicide resistance management language be added to all glyphosate labels” and to require measures “for the pesticide registrants to provide growers and users with detailed information and recommendations to slow the development and spread of herbicide resistant weeds”;

  • Inclusion on labels of a non-target organism advisory statement to alert users of potential impact to non-target organisms; and

  • “EPA is also proposing certain labeling clean-up/consistency efforts to bring all glyphosate labels up to modern standards.”

EPA states that these measures were discussed with glyphosate registrants, who do not oppose the proposed risk mitigation measures outlined in the PID.

The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361.  Public comments are due by July 5, 2019.  In addition to the PID, EPA is also posting to the glyphosate docket EPA’s response to comments on glyphosate’s usage and benefits (dated April 18, 2018), EPA’s response to comments on the human health risk assessment (dated April 23, 2019), and EPA’s response to comments on the preliminary ecological risk assessment (dated November 21, 2018). 

This PID was issued shortly after the Agency for Toxic Substances and Disease Registry’s announcement on April 8, 2019, of the opening of a docket on the draft toxicological profile for glyphosate.  84 Fed. Reg. 13922.  ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile.  Comments are due by July 8, 2019.

Commentary

EPA’s PID and related documents, along with ATSDR’s draft profile and the peer review which will follow, can be expected to become part of the larger debate about the potential risks of glyphosate.  In 2017, EPA evaluated the carcinogenic risk of glyphosate, and released its draft human health and ecological risk assessments.  See our December 19, 2017, blog item "EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment" for more information. 

EPA’s PID is interesting not only for the conclusions EPA reached following its review of data submitted by registrants in response to a data call-in (DCI) and following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel’s (SAP) meeting to consider and review scientific issues related to EPA’s evaluation of the carcinogenic potential of glyphosate, but for the issues that remain to be addressed.  Notably, EPA states that it has not considered the petition filed on September 27, 2018, to reduce glyphosate’s tolerance because the petition was filed after the comment period for the human health and ecological risk assessments closed.  Instead, EPA plans to post the petition in the glyphosate docket and address the petition concurrently with the development of the Interim Registration Review Decision.

In addition, EPA has not in the PID or related documents addressed issues regarding its Endangered Species Act (ESA) assessment or its Endocrine Disruptor Screening Program (EDSP) activities.  EPA states it intends to complete an assessment of risk to ESA-listed species prior to completing its final registration review decision for glyphosate, and that it also will make a EDSP determination under Federal Food, Drug, and Cosmetic Act (FFDCA) Section 408(p) before completing its registration review.  EPA also notes that it continues to evaluate risks to pollinators, and that if it determines “that additional pollinator exposure and effects data are necessary to help make a final registration review decision for glyphosate, then the EPA will issue a DCI to obtain these data.”  Although there are significant areas that remain to be resolved, EPA issued the PID “so that it can (1) move forward with aspects of the registration review case that are complete and (2) implement interim risk mitigation.”

©2020 Bergeson & Campbell, P.C.

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Lisa Campbell, Bergeson PC, Federal Insecticide Fungicide Rodenticide Act attorney, TSCA lawyer, environmental statutes legal counsel, regulation compliance law
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Lisa Campbell founded Bergeson & Campbell, P.C. (B&C®) with Lynn Bergeson. Today her practice focuses on many aspects of pesticide and chemical regulation. She counsels clients on a wide range of issues pertaining to exposure and risk assessment, risk communication, and related legal and regulatory aspects of pesticide programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). She also counsels B&C clients on various chemical-specific programs under the Toxic Substances Control Act (TSCA) as well as chemicals regulation and...

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Lisa R. Burchi, Toxic Substances Control Act Attorney, FIFRA Lawyer, Bergeson and Campbell, Law firm
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Lisa Burchi's work involves Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulatory matters. She has particular expertise in data compensation matters under FIFRA, the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Biocide Product Regulation (BPR), and Plant Protection Product (PPP) Regulation, and also counsels on matters related to California law, including Proposition 65 and the recent Green Chemistry Initiative/Safer Consumer Products Regulations. She delivers more than 18 years of experience in highly specialized fields. Though she works for Washington, DC-based Bergeson & Campbell, P.C. (B&C®), she lives in and is licensed in the State of California.

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James V. Aidala, Bergeson, Senior Government Affairs Consultant, Toxic Substances Lawyer
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Jim Aidala, Senior Government Affairs Consultant with Bergeson & Campbell, P.C. is a critical ally for any client addressing chemical policy, legislative, and related issues. He has been intimately involved with the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) legislative reauthorization and key regulatory matters for over two decades. Mr. Aidala brings extensive legislative experience on Capitol Hill and past experience as the senior official at the U.S. Environmental Protection Agency (EPA) for pesticide...

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