Document Dd4v1Ly5QVwEJ1pbwDjOdeeYQ

To: Cc: From: Sent: Subject: Beck, Nancy[Beck.Nancy@epa.gov] Jackson, Ryan[jackson.ryan@epa.gov] hutchinsont@gtlaw.com Thur 9/7/2017 3:08:11 PM RE: EPA regulation of mosquito-related products Thanks Ryan and thanks Nancy. The Honorable Tim Hutchinson Senior Director (US House 93-97; US Sen. 97-03) Greenberg Traurig, LLP | 2101 L Street N.W. | Washington, D.C. 20037 Tel 202.530.8512 hutchinsont@qtlaw.com | www.qtlaw.com cenbergTraui ig From: Beck, Nancy [mailto:Beck.Nancy@epa.gov] Sent: Tuesday, September 05, 2017 6:38 PM To: Hutchinson, Tim (SenDir-DC-GovLP) Cc: Jackson, Ryan Subject: RE: EPA regulation of mosquito-related products Tim, Ryan forwarded your message to me and asked me to respond. The guidance is currently still at 0MB undergoing their typical interagency review process. As 17cv1906 Sierra Club v. EPA ED_001523_00002108-00001 you likely know, this involves multiple back and forths among the agencies with OMB to work towards resolving all concerns. Once the deliberative dialogue is concluded, FDA will finalize the guidance and then EPA will assume authority. Unfortunately, I can't predict exactly when this will happen, but I do know the agencies are all working together to get to resolution. As Tom Bostick checks in regularly, once we have some news, I will surely pass it along to him as well as other working with Intrexon. I would be happy to keep you updated as well. Please let me know if you have any other questions. Regards, Nancy Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 M: 202-731-9910 beck.nancy@epa.gov Begin forwarded message: From: <hutchinsont@gtlaw.com> Date: September 5, 2017 at 3:44:54 PM EDT To: <jackson.ryaii@epa.gov> Cc: <mangasr@gtlaw.com> Subject: EPA regulation of mosquito-related products Ryan, I may have missed your response to my inquiry (I have been in and out of the office on vacation). Thanks for any status report you can provide.-- Tim 17cv1906 Sierra Club v. EPA ED_001523_00002108-00002 Ryan-- I hope you are well and have a little time to catch up this month. I know it has been a hectic few months. I was hoping that you could provide a little information about a jurisdictional issue involving EPA and FDA. I represent Intrexon, which has a subsidiary (Oxitec) that produces a genetically modified mosquito that may become a valuable resource for preventing the spread of the Zika virus and other diseases transmitted by the same type of mosquito (aedes aegypti). Back in January, EPA and FDA issued draft guidance for industry on the regulation of mosquito-related products and took public comments. It is my understanding that this guidance is very close to being finalized, and may have already cleared OMB review. I was wondering if you could share any information about when this guidance is expected to be finalized and take effect. As always, thanks for your assistance. Tim The Honorable Tim Hutchinson Senior Director (US House 93-97; US Sen. 97-03) Greenberg Traurig, LLP | 2101 L Street N.W. | Washington, D.C. 20037 Tel 202.530.8512 hutchinsont@gtlaw.com | www.gtlaw.com eenbergTraung 17cv1906 Sierra Club v. EPA ED_001523_00002108-00003 If you are not an intended recipient of confidential and privileged information in this email, please delete it, notify us immediately at postmaster@gtlaw.com, and do not use or disseminate such information. 17cv1906 Sierra Club v. EPA ED_001523_00002108-00004