UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

Via E-Mail May 17,2016
David B. Weinberg OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

Wiley Rein LLP, Counsel to Dow AgroSciences LLC and ADAMA 1776 K StNW Washington, DC 20006
David E. Menotti Crowell & Moring LLP, Counsel to FMC Corporation 1001 Pennsylvania Ave, NW Washington, DC 20004 Subject: Requests for Extension of the Comment Period for the Draft Biological Evaluations for Chlorpyrifos, Diazinon, and Malathion
Dear Mr. Weinberg and Mr. Menotti:
EPA has reviewed your April 29, 2016 request for a 120-day extension ofthe comment period (after EPA has corrected deficiencies noted in the materials provided to the public) for the draft biological evaluations for chlorpyrifos, diazinon, and malathion

. A 120-day extension ofthe comment period was requested by your clients, Dow AgroSciences LLC , Makhteshim Agan ofNorth America, Inc. (known as ADAMA), and FMC Corporation, for the following reasons: 1) The components ofthe draft biological evaluations for chlorpyrifos, diazinon, and malathion total in excess of 12,000 pages and link to thousands ofExcel files and model output files that contain millions oflines ofdata

. More time is needed to review this large volume ofinformation. 2) The current 60-day comment period is insufficient in light ofthe importance of these draft biological evaluations, which establish a precedential "interim approach" to ESA analysis that is crucial to the future ofthe three active ingredients at issue and the pesticide registration review program in general. 3) As stated in your request, many electronic links in the materials that EPA provided do not work, many citations and cross-references are missing and/or unidentifiable, and working links often refer to empty files. These alleged errors were documented in Appendix A, which was enclosed with the April29, 2016 letter, and must be corrected before stakeholders can conduct thorough review of the materials provided.

1EPA has received similar extension requests from Edward M. Ruckert, representing the American Mosquito Control Association (letter dated May 10, 20 16), CropLife America (letter dated May 6, 2016), and James Callan, representative for 39 grower groups (letter dated May 9, 2016). This letter responds to all stakeholders seeking
an extension ofthe comment period for the draft biological evaluations.
EPA understands the challenges ofreviewing such a large volume ofinformation. To allow additional time to review the draft biological evaluations, EPA released on its endangered species program website (https ://www.epa.gov/endangeredspecies/implementing-nas-report-recommendations-ecological-risk-assessmentendangered-and) a large portion ofthese biological evaluations in December 2015. Among the materials released in December for each chemical were: • Chapter 1-the problem formulation and associated appendices (in which EPA outlined its analysis plan) • Chapter 2-the effects characterization and associated appendices (in which EPA reviewed the existing toxicological database and identified thresholds used to evaluate direct and indirect effects to listed species and designated critical habitat) • Chapter 3-the environmental transport and fate characterization and associated appendices (in which EPA reviewed the existing environmental fate and transport data and the results ofaquatic and terrestrial modeling)
Stakeholders had approximately four months (nearly 120 days) to review and familiarize themselves with these materials before EPA released Chapter 4

- the effects determinations for each chemical. Stakeholders were then given an additional two months (60 days) to review the materials in Chapter 4. In addition, on May 5, 2016, EPA held a public webinar to give an overview ofthe interim method used to assess risk to listed species, guide stakeholders through the biological evaluations, and to answer questions.
EPA and its federal partners, the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (together, the Services), are working under a court-mandated deadline to complete final biological opinions for all three chemicals by December 2017. EPA is denying your April 29, 2016 request for an extension ofthe comment period because oftwo reasons. Firstly, extending the comment period would not give EPA adequate time to review the comments, revise the draft biological evaluations, issue the final biological evaluations, and it would not give the Services enough time to complete the draft and final biological opinions for each ofthe three chemicals by the courtmandated deadline. Secondly, EPA believes that the total amount oftime that support materials and the biological evaluations were available for stakeholder review was adequate.
EPA understands that the interim approach established in these biological evaluations are crucial to the future ofthe three active ingredients at issue, and impact the general registration review program. However, this interim approach is subject to further refinement, and there will be further opportunities for stakeholder feedback in the future

.
2For example, EPA anticipates holding a stakeholder workshop in June 2016 to discuss possible ideas for refinement.
In your April 29, 2016 letter, you attached a document titled "Appendix A: Preliminary Analysis ofMissing, Omitted, or Incorrect Information in Biological Evaluations ofChlorpyrifos, Diazinon, and Malathion" which listed alleged errors, broken links, missing references, incorrect hyperlinks, and other issues which hindered stakeholder review ofthe biological evaluations

. EPA has reviewed Appendix A and has determined that many allusions to missing or omitted information are in fact not actually errors, but refer to proprietary data or special data not otherwise publicly available

. EPA is not able to provide access to these data

. However, EPA has provided additional related information and additional clarification where necessary, including additional citations, corrected links, and the correction oftypos

. Please see the enclosed EPA response titled Response to a Request for Comment Period Extension: Notice of Availability of Draft Biological Evaluations ofChlorpyrifos, Diazinon, andMalathion, dated May 17, 2017.
Ifyou have any questions about this letter, please contact Neil Anderson ofmy staff at anderson.neil@epa.gov or 703-308-8187

. Sincerely,

Yu- ing Guilaran Division Director Pesticide Re

-evaluation Division Office ofPesticide Programs

cc : Imad Saab, Sr. Director, Environmental Policy, Crop Life America Edward M. Ruckert, Attorney, American Mosquito Control Association James Callan, James Callan Associates LLC , Representative for 39 grower groups

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