SUBJ:	Correction to Certain Information in 84 Fed. Reg. 47,287 (Sept. 9, 2019)

FROM:	Richard Keigwin, Director, Office of Pesticide Programs

TO:	Docket ID#: EPA-HQ-OPP-2017-0433

DATE:	October 8, 2019 

In the Federal Register at 84 Fed. Reg. 47,287 (Sept. 9, 2019), a Notice entitled "Pesticides; Interim Process for Evaluating Potential Synergistic Effects of Pesticides During the Registration Process; Notice of Availability and Request for Comments" was published which contained some inaccuracies in the "Background" section regarding litigation concerning "Enlist Duo Herbicide."  Although those inaccuracies are not relevant to the "Interim Process for Evaluating Potential Synergistic Effects of Pesticides During the Registration Process" that is the subject of the Federal Register Notice, those inaccuracies are corrected in this document.  The "Background" section of the Federal Register Notice at 84 Fed. Reg. 47,287 (Sept. 9, 2019) should have stated the following:

II. Background
EPA regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., which governs the production, use, distribution, and sale of pesticides. Under FIFRA, pesticides distributed or sold in the United States must first be registered with EPA unless they qualify for an exemption. A cornerstone of the pesticide registration process is the data requirements that applicants must fulfill regarding the pesticide's effects on human health, the environment, and in some cases, its efficacy in controlling pests.
 
The burden of demonstrating that a product meets the standards for registration rests on the registrant or applicant for registration. To obtain registration, applicants are responsible for citing or generating all data necessary to meet data requirements specified by EPA's regulations at 40 CFR part 158. An ecological risk assessment is one key assessment EPA performs to determine what risks are posed by a pesticide and whether changes to the use or proposed use are necessary to protect the environment. To inform such assessments, EPA requires a range of data in specific categories including: Product chemistry, environmental and mammalian toxicity, environmental fate, residue chemistry, reentry exposure, and spray drift.
 
EPA's historical process for evaluating pesticide ecological risks has relied on toxicity information from studies conducted with single active ingredients based on the lack of information on pesticide interactions and the expectation that they are rare. In 2013, the National Research Council (NRC) (Ref. 1) stated that toxicological interactions between pesticide active ingredients that produce GTA effects are rare and suggested that the Agency consider pesticide active ingredient interactions when the best available scientific evidence supports the evaluation.
 
However, during the pendency of a lawsuit challenging EPA's 2014 decision to register a new pesticide product containing two herbicide active ingredients (Enlist Duo Herbicide) (Ref. 2), EPA became aware that the registrant had made claims in a patent application to the U.S. Patent and Trademark Office (USPTO)  -  but not to EPA  -  that the two active ingredients in Enlist Duo produced GTA effects towards pest species. EPA subsequently discovered that a number of other registrants were making similar claims of GTA effects towards pest species before the USPTO, but were not disclosing these GTA claims to EPA. Based on the registrant's claims to the USPTO, EPA asked the court to remand the Enlist Duo Herbicide registration decision to EPA for consideration of its potential for synergistic effects (Ref. 3). Although EPA ultimately determined that the two active ingredients in Enlist Duo did not have GTA effects and the registrant withdrew the patent application in question, in 2016 and 2017 EPA received petitions asking the Agency to require registrants to provide information on potential synergy for consideration in EPA's ecological risk assessments. In addition, subsequent public comments submitted regarding pesticide regulatory decisions continue to include this issue as a concern.

