Message
From: Sent: To: CC:
Subject:
Bolen, Derrick [/0=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=1FFC58B0468C4DECA51A8BAD735B7D95-BOLEN, DERR] 6/26/2018 3:48:13 PM support@fkec.org Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy]; Jack Norris
RE: Oxitec
Barry-
Please plan to arrive 10 minutes early at 1201 Constitution Ave. NW. I can be reached at 202-564-3349 for an escort up.
Thank you, Derrick Bolen
From: support@fkec.org [mailto:support@fkec.org]
Sent: Tuesday, June 26, 2018 9:09 AM
To: Bolen, Derrick <bolen.derrick@epa.gov>
Cc: Beck, Nancy <Beck.Nancy@epa.gov>; Jack Norris {
Ex. 6
j
Subject: Re: Oxitec
Hi Derrick,
Thanks for the quick response. 2:00PM on July 13th is great for us. Dr. Jack Norris and I will be attending. Our discussion interests include the points that we both we have submitted during the comment periods and will likely include other comment submissions both from other response, such as Oxitec/lntrexon and other substantive comments that highlight concerns, risks, performance and standards applicable to the OX513A.
Our goals remain focused on assuring human and ecological health and safety, and the science of assessing this technology within the background of outstanding societal needs that have affect on risk, versus reward, decision making.
Please provide us specifics of where we will be meeting and any other information that may required for credentialing prior to our visit.
We are looking forward to meeting with the EPA evaluation team.
Sincerely,
Barry Wray Executive Director Florida Keys Environmental Coalition PO Box 205 Key West, FL 33041 www.fkec.orq support@fkec.orq 305-304-9898......
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00044261-00001
On Jun 25, 2018, at 12:29 PM, Bolen, Derrick <bolen.derrick@epa.gov> wrote: BarryDoes July 13th at 2pm work for your schedule? Thank you, Derrick Bolen
From: Beck, Nancy
From: support@fkec.org Date: June 20, 2018 at 10:18:27 AM EDT To: "Beck, Nancy" <Beck.Nancy@epa.gov> Cc: "Keller, Kaitlin" <keller.kaitlin@epa.gov>, Jack Norris Subject: Re: Oxitec
Ex. 6
Hi Nancy,
We appreciate your efforts to re-open the comment period on the proposed EUP to release the OX513A in the FL Keys and in Harris County TX. We trust that many additional informative comment have been able to reach your team over this period and large disclosure was provide from the activities in the Cayman, that will have weight in your team's considerations.
As a follow up to prior emails, we would like to request a meeting with you and your science team to discuss this proposed EUP and our concerns and experience. Our team for this discussion is limited to Dr Jack Norris and I presently. For our schedules July 13 seem to fit best, but we have some flexibility, so please let us know if there are time that fit with your schedule in the mid July weeks. We hope that provides sufficient time for your team to investigate the responses received during the comment period and that our meeting will be more robust with that content.
We look forward to meeting with you and your team. Please let us know if the 13th is good for you and your tema and if not what other dates you could suggest.
Sincerely,
Barry Wray Executive Director Florida Keys Environmental Coalition PO Box 205 Key West, FL 33041 www.fkec.org
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00044261-00002
support@fkec.org 305-304-9898
<image001.png>
On May 11, 2018, at 8:43 AM, Keller, Kaitlin <keller.kaitlin(S>epa.gov> wrote:
Good Morning Barry,
We do conduct various levels of outreach beyond the Federal Register process depending on the issue, but the best way to ensure you receive updates on pesticide-related issues is to sign up for our email list, which is at the bottom of EPA's pesticides homepage. Below is the update that went out this week on this issue, also now available on our web here. Please share with your stakeholders as appropriate.
Nancy would be happy to meet with you and to hear your concerns. Derick Bolen (cc'ed) can work with you to find a date that works for you and our office. A quick note in advance of scheduling, the timeframe you suggested might present a bit of a challenge--our office has multiple key statutory deadlines the 3rdweek of June, and Nancy will be on travel the last week of June--but Derrick always finds a way to make it work. Thank you in advance for your patience and flexibility. We also still encourage you to submit any substantive comments to the docket prior to comment period closing on June 7, 2018.
Best Regards, Kaitlin
Kaitlin Keller, Special Assistant Office of Chemical Safety and Pollution Prevention U.S. Environmental Protection Agency
(202]564-7098
EPA Pesticide Program Updates
From EPA's Office of Pesticide Programs www, epa.aov/pesticfdes
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00044261-00003
May 10, 2018
In This Update:
EPA Reopens Public Comment Period on Application for Experimental Use Permit to Combat Mosquitoes
in response to requests from stakeholders, EPA is reopening the public- comment period regarding an application from Oxitec Ltd. for an experimental use permit (EUR) for genetically engineered 0X513A,Redes aegypti mosquitoes.
EPA first announced the availability of Oxitec's application for an experimental use permit on March 9 "'A X " ""L"; A fX ' Following review of the application, data and public comments, EPA wii decide whether to issue or deny the EUR request and, if issued, the conditions under which the study to he conducted.
Aedes aegypti mosquitoes can spread several diseases of significant human health concern, ineludim the Zika virus Oxitec's genetically engineered Aedes aegypti mosquitoes are designed to suppress wild Aedes aegypti populations. Genetically engineered male mosquitoes are released Into the environment to mate with wild female mosquitoes, and the resulting offspring do nof survive.
Oxitec's proposed experimental program Is designed to take place over 24 months in Harris County, Texas, and Monroe County, Florida. For additional details view the entire proposal
Public comments about this proposed EUR should be submitted to www regulatiens.gov under docket # EPA-HQ-OPP-2017-0756 on or before June 7, 2018
ERA distributes its Pesticide Program Updates to external stakeholders and citiasnis who have exprassad an interest in the agency's Denticida program activities and decisions. This update service is pad of ERA'S continuing effort to improve public sees innata! pesticide information.
For general questions about pesticides and pesticide poisoning prevention, contact the National Pesticide information Center (NPiC), by email at ng!n||ans,.nm sxAs er, by visiting btt;>://n;>fo.otst.edn.
For information abois ongoing activities in tire Office of Pesticides Programs, wait our hi
From: support@fkec.org [mailto:suppart@fkec.Qrg] Sent: Tuesday, May 08, 2018 9:38 AM To: Beck, Nancy <Beck.Nancy@epa.gov> Cc: Keller, Kaitlin <keller.kaitlin@epa.gov> Subject: Re: Oxitec
HI Nancy,
Thank you so much for reaching out to assure we were informed. We realize the standard notification process is via the the FR, but does the
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00044261-00004
EPA ever reach out to local media with either a direct Press Release, or courtesy email of some sort direct communication to media in the community affected, to let them know that there is a subject of interest for their citizens. Both Monroe County, FL and Harris County, TX has citizens who need to be aware and the FR is not something that even the press follows well. We feel the EPA provides a larger and more readily published voice that would reach deeper into these communities with standing on this issue.
As the EPA science team begins the investigation. We would welcome a chance in the next 45 to 60 days to discuss the evaluation of the OX513A EUP application and the safety concerns we feel have not been address in prior reviews.
Our groups within the Coalition are very focused on the scientific evaluation of this technology and as you may be aware we have embraced other Sterile Insect Techniques, that provide a clearer understanding of risk and benefits than the historical Oxitec OX513A field trial applications have in the past. We have been working on this issue for over 7 years, so the knowledge within our work is deep and some of the discoveries that our member have made, we believe will help the comprehensive outcome of the EPA's considerations surrounding the Oxitec EUP Application.
Given the new comment period will close in mid June, perhaps a 3rd week of June, or second week of July meeting (trying avoiding any holiday conflicts) will provide an opportunity for your team to meet a few of our key contributors and discuss our concerns. We are hopeful that this will include representatives from Harris County as well, but the awareness in that community is very low, hence our questions about the public relations/ Press Release outreach.
Thanks again for your direct outreach initiative to us and you and your team's commitment to service. We look forward to an opportunity to meet in person.
Sincerely,
Barry Wray Executive Director Florida Keys Environmental Coalition PO Box 205 Key West, FL 33041 www.fkec.org support fkec.org 305-304-9898
<image001.png>
On May 8, 2018, at 8:26 AM, Beck, Nancy <Beck. Nancy@epa.gov> wrote:
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00044261-00005
Barry, Thank you for your input. We have reopened/extended the comment period. The FR notice announcing the extension is here: https://www.gpo.gov/fdsys/pkg/FR-2018-0508/pdf/2Q1809777.pdf?utm campaign=subscription%20mailing%20l ist&utm source=federalregister.gov&utm medium=em ail
Regards, Nancy
Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273
beck.nancy@epa.gov
From: support(Sfkec.org [mailto:support(Sfkec.org] Sent: Tuesday, April 3, 2018 2:33 PM To: Beck, Nancy <Beck.Nancy@epa.gov> Subject: Oxitec
Dear Nancy,
We realize you are the team lead on the OX513A Oxitec Genetically Modified Mosquito (GMM) evaluation. While there are many comments being worked on, there is also not an ample amount of time for people to respond with the quality of comments needed to support the investigative level we feel this technology and this particular company should be viewed with.
The most recent proposal expands venues and seems to have changes in both claims and process for testing these mosquitoes. While it is not appropriate to go into deep discussions here, we do feel it appropriate that the EPA should afford ample time for groups like ours to work with our members and assemble the scientific input that will help the EPA perform with the most current observations, data and concerns. We humbly ask that the comment period be expanded to a minimum of 60 days in total.
Oxitec has had years to perfect their story, ever evolving as it may be. We are the affected citizens and have witnessed the difficulty of combating the resources es of a $4B company with just your passions, communication network and intellect. We do however
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00044261-00006
represent the best of what our nation is about, the people asking relevant and challenging questions, most of which Oxitec has not answered over the 6 plus years that we have been engaging them.
Please afford the public additional time to present a clearer picture of Oxitec, along with the concerns and questions we should all be asking.
My sincere thanks,
Barry Wray Executive Director Florida Keys Environmental Coalition PO Box 205 Key West, FL 33041 www.fkec.orq support@fkec.org 305-304-9898
<image001.png>
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00044261-00007