RESPONSE TO EPA’S DRAFT BIOLOGICAL EVALUATION FOR MALATHION FINAL REPORT Prepared by: Roger L. Breton1, Melissa Whitfield Aslund2, Sara I. Rodney1, Gillian E. Manning1, Yvonne H. Clemow1, Katie L. Wooding1, Colleen D. Greer3, R. Scott Teed1, Adric D. Olson3, Michael F. Winchell 4, Naresh Pai4, Lauren Padilla4, Tammy Estes4 and Katherine Budreski4 1Intrinsik Environmental Sciences, Inc. 1125 Colonel By Dr., CTTC – Suite 3600 Ottawa, ON, Canada K1S 5R1 2Intrinsik Environmental Sciences, Inc. 6605 Hurontario Street, Suite 500 Mississauga, ON, L5T 0A3 3Intrinsik Environmental Sciences (US), Inc. 41 Campus Dr., Suite 202, New Gloucester, ME, USA 04260 4Stone Environmental, Inc. 535 Stone Cutters Way, Montpelier, VT USA 05602 Prepared For: Cheminova A/S (EPA Company No.: 4787) 1600 Wilson Boulevard, Suite 700 Arlington, VA 22209 Date: June 10, 2016 1125 Colonel By Dr., Carleton University Campus, CTTC – 3600 Ottawa, ON K1S 5R1 Tel: 613-761-1464 ▪ Fax: 613-761-7653 ▪ www.intrinsikscience.com Page 1 of 472 FINAL REPORT STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS No claim of confidentiality, on any basis whatsoever, is made for any information contained in this document. I acknowledge that information not designated as within the scope of FIFRA sec. 10(d)(1)(A), (B) or (C) and which pertains to a registered or previously registered pesticide is not entitled to confidential treatment and may be released to the public, subject to the provisions regarding disclosure to multinational entities under FIFRA sec. 10(g). This statement supersedes any other claim of confidentiality that may appear in this report. Submitter: [signature]: Paul Whatling Senior Registration Manager FMC Corporation EPA Agent for Cheminova A/S June 10, 2016 This document is the property of Cheminova A/S and FMC Corporation, and as such is considered to be confidential for all purposes other than compliance with FIFRA sec. 10. Submission of these data in compliance with FIFRA does not constitute a waiver of any right to confidentiality, which may exist under any other statute or in any other country. Response to EPA’s Draft Biological Evaluation for Malathion June 10, 2016 Intrinsik Environmental Sciences Inc. – Project # 60335 Page 2 of 472 FINAL REPORT Statement of Good Laboratory Practice Compliance This document is a response to EPA’s draft Biological Evaluation (BE) for malathion. It is not required to comply with 40CFR Part 160. Author and Title Signature Date Roger L. Breton, June 10, 2016 Senior Scientist and Project Manager Dr. Melissa L. Whitfield Aslund Scientist June 10, 2016 Sara I. Rodney, June 10, 2016 Scientist Gillian E. Manning, June 10, 2016 Environmental Risk Analyst II Yvonne H. Clemow, June 10, 2016 Environmental Risk Analyst II Katie L. Wooding, June 10, 2016 Environmental Risk Analyst II Colleen D. Greer, June 10, 2016 Environmental Risk Analyst II R. Scott Teed, June 10, 2016 Senior Scientist Adric D. Olson, June 10, 2016 Environmental Risk Analyst II Michael F. Winchell Senior Environmental Modeler / GIS June 10, 2016 Specialist Naresh Pai Senior Environmental Modeler June 10, 2016 Lauren Padilla Senior Environmental Modeler June 10, 2016 Tammy L. Estes June 10, 2016 Senior Research Scientist Katherine Budreski June 10, 2016 Senior GIS Specialist Sponsor/Submitter and Title Signature Date Paul Whatling Senior Registration Manager June 10, 2016 FMC Corporation EPA Agent for Cheminova A/S Additional Contributors Include: Nino Devdariani from Intrinsik Environmental Sciences Inc. and Dr. Rick Reiss from Exponent. Response to EPA’s Draft Biological Evaluation for Malathion June 10, 2016 Intrinsik Environmental Sciences Inc. – Project # 60335 Page 3 of 472 FINAL REPORT DISCLAIMER Intrinsik Environmental Sciences, Inc. (Intrinsik) developed this report for Cheminova Inc. (hereafter referred to as Cheminova), solely for the purpose stated in the report. Intrinsik does not accept any responsibility or liability related to the improper use of this report or incorrect data or information provided by others. Intrinsik has reserved all rights in this report, unless specifically agreed to otherwise in writing with Cheminova. Response to EPA’s Draft Biological Evaluation for Malathion June 10, 2016 Intrinsik Environmental Sciences Inc. – Project # 60335 Page 4 of 472 FINAL REPORT EXECUTIVE SUMMARY The Environmental Protection Agency (EPA or “the Agency”), in conjunction with the Fish and Wildlife Services (FWS), National Marine and Fisheries Service (NMFS) and United States Department of Agriculture (USDA) prepared draft Biological Evaluations (BEs) for three pilot chemicals: chlorpyrifos, diazinon and malathion. These draft BEs are the first ever national assessments of the potential effects of pesticides to listed species (threatened and endangered) attempted by the federal government. Cheminova A/S (hereafter referred to as “Cheminova”) is the sole manufacturer and primary registrant in the United States for the technical form of malathion (CAS Registry Number 121- 75-5). All other registrants of technical malathion obtain their material from Cheminova and all end-use products registered in the United States are produced from Cheminova’s technical malathion. In 2015, Cheminova A/S and Cheminova, Inc., were acquired by FMC Corporation (FMC). Cheminova Inc.’s end-use product registrations are in the process of being transferred to FMC. The registrations currently held by Cheminova A/S will be transferred to FMC in the near future. When these transfers are accomplished, FMC will supplant Cheminova as the “applicant”. Although we often only refer to Cheminova in this document, the comments contained herein were developed on behalf of Cheminova and FMC and reflect the positions of both companies. On April 11th, 2016, EPA released the draft BEs for public comment in support of registration review for these pesticides. This date marked the start of a 60-day public comment period. The comment period for submission of comments on the draft BEs ends on June 10th, 2016. On April 29th, 2016, a 120-day extension to the comment period was requested by Dow AgroSciences LLC, Makhteshim Agan of North America, Inc. (Adama) and Cheminova to commence after EPA corrected various missing and broken links and provided other missing information that should have been provided with release of the draft BEs. Extension requests were also submitted to EPA by Edward M. Ruckert, representing the American Mosquito Control Association (May 10th, 2016), CropLife America (May 6th, 2016) and James Callan, representing 39 grower groups (May 9th, 2016). EPA responded on May 17th, 2016 by denying the extension. Given their size and complexity, this denial compromised our ability to thoroughly evaluate the draft BEs. In the justification, EPA cited a court-mandated deadline that they and the Services are working under, as well as the early release of parts of the draft BEs in December, 2015 (allowing for some review prior to the official comment period). Notably, substantial changes made to the draft documents posted in December required additional efforts by affected parties to identify and evaluate modifications made to the documents, supporting models, the missing data, broken links, and other errors in the draft BEs. In addition, the court-mandated deadline is not a reasonable excuse for not allowing a fair and substantive review of the draft BEs by affected parties. Registration and/or re-registration of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) constitutes a federal action under the Endangered Species Act (ESA). Under ESA Section 7, in some circumstances EPA must consult with the Fish and Wildlife Response to EPA’s Draft Biological Evaluation for Malathion June 10, 2016 Intrinsik Environmental Sciences Inc. – Project # 60335 Page 5 of 472 FINAL REPORT Service and/or National Marine Fisheries Service (‘the Services’) to ensure that a pesticide’s registration is not likely to jeopardize the continued existence of federally endangered and threatened species (hereafter, ‘listed species’) or result in the destruction or adverse modification of designated critical habitat. Therefore, these draft BEs purport to provide initial nationwide assessments of the potential effects of the pilot pesticides to listed species and their designated critical habitat. Potential effects to candidate and proposed species and critical habitat proposed for listing under Section 7 of the ESA were also considered. In the draft BE for malathion (EPA, 2016a), EPA followed the Interagency Interim Approaches (Agencies, 2013), a process agreed to by EPA, the Services and USDA to implement some of the recommendations from the National Academy of Science’s National Research Council (“NRC”) report “Assessing Risks to Endangered and Threatened Species from Pesticides” (NRC, 2013). The NRC recommended a three step process to evaluate potential risk and satisfy EPA’s consultation obligations under Section 7 of the ESA. At each step, EPA assigns a risk finding to each species and/or critical habitat (i.e., Step 1: ‘No Effect/May Affect’ determination, Step 2: ‘Not Likely to Adversely Affect (NLAA)/Likely to Adversely Affect (LAA)’). Under this procedure, species and/or critical habitat receiving a ‘MA/NLAA’ finding are to be subject to informal consultation with the Services to determine concurrence. Species and/or critical habitat that considered MA/LAA enter Step 3, where a formal consultation occurs with the Services is to occur. A biological opinion is generated by the Services