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 of the 

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 of the comment period was requested by your clients, Dow 

AgroSciences LLC, Makhteshim Agan of North America, Inc. (known as ADAMA), and 

FMC Corporation, for the following reasons: 

1) The components of the draft biological evaluations for chlorpyrifos, diazinon, and 

malathion total in excess of 12,000 pages and link to thousands of Excel files and 

model output files that contain millions of lines of data. More time is needed to 

review this large volume of information. 

2) The current 60-day comment period is insufficient in light of the importance of 

these draft biological evaluations, which establish a precedential "interim 

approach" to ESA analysis that is crucial to the future of the 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. 

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EPA 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 of the comment period for the draft biological evaluations. 

EPA understands the challenges of reviewing such a large volume of information. 

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 of these 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 of aquatic 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 of the 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 of the 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 of the three chemicals by the courtmandated deadline. Secondly, EPA believes that the total amount of time 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 of the 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 . 

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For 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 of Missing, Omitted, or Incorrect Information in Biological 

Evaluations of Chlorpyrifos, 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 of typos. Please see the enclosed EPA response titled 

Response to a Request for Comment Period Extension: Notice of Availability of Draft 

Biological Evaluations ofChlorpyrifos, Diazinon, and Malathion, dated May 17, 2017. 

If you have any questions about this letter, please contact Neil Anderson of my staff at 

anderson.neil@epa.gov or 703-308-8187. 

Sincerely, 

Yu- ing Guilaran 

Division Director 

Pesticide Re-evaluation Division 

Office of Pesticide 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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