Message From: Sent: To: CC:
Subject:
Keith Pitts [kpitts@marronebio.com] 1/24/2018 12:54:55 AM McNally, Robert [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=efa5514317e34b9895687d73730fdde9-Robert McNally] Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy]; Keith Jones [jones@bpia.org]; David Beaudreau [dbeaudreau@dclrs.com]; Terry Stone [terry.stone@agrinos.com]; Jeff Blackwood [jeff.blackwood@basf.com]; Keller, Kaitlin [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=d7a6bl5adfd745c6adalcl21dec27ac4-Keller, Kai] Re: Biostimulant Question
Thanks Bob, we'll loop back in the next few days via Dave and Keith. I think we want to identify the right person to help pull together data to support a robust case. Having a better idea of what is needed to support an OIRA review will help us decide who that person or entity might be. As you know, the situation is a bit dispersed and ambiguous right now for this sector and the products seeking market entry. So, clarity is a goal here. Thanks, K
Keith Pitts Chief Sustainability Officer SVP, Regulatory and Government Affairs Marrone Bio Innovations 1540 Drew Avenue Davis, CA 95618 (530) 750-2800
^ E x . 6 Personal Privacy (PP) ^ Q g j ]
kpitts@marronebio.com
From: McNally, Robert <mcnally.robert@epa.gov> Sent: Tuesday, January 23, 2018 4:48 PM Subject: Re: Biostimulant Question To: Keith Pitts <kpitts@marronebio.com> Cc: Beck, Nancy <beck.nancy@epa.gov>, Keith Jones <jones@bpia.org>, David Beaudreau <dbeaudreau@dclrs.com>, Terry Stone <terry.stone@agrinos.com>, Jeff Blackwood <jeffblackwood@basf.com>, Keller, Kaitlin <keller.kaitlin@epa.gov>
Sounds good Keith.
Bob Sent from my iPhone
On Jan 23, 2018, at 7:40 PM, Keith Pitts <kpitts@marronebio.com> wrote: Nancy, thank you. If the document is still with EPA, both BPIA and BSC would be interested in seeing what we can do to assist in pulling together data to support advancing the guidance.
Both BPIA and BSC have been working with Lynn B. on the EPA guidance and with Stan Abramson on Farm Bill language on legal aspects of the biostimulant policy, and both
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00039553-00001
organizations are willing to chip in to pull together data needed to support the economic and cost-benefit analysis aspects that also need to be covered.
In order to make sure our data gathering hits the necessary mark, we will reach out to Bob and request a meeting. We will also review the OMB Circular A-4 and see if it provides any insights about what would be useful and applicable to our particularly conundrum. Keith and David, I think the ball is in our court to follow up with Bob. Thanks, with best wishes, Keith
Keith Pitts Chief Sustainability Officer Senior Vice President-Regulatory and Government Affairs Marrone Bio Innovations 1540 Drew Avenue Davis, CA 95618
kpitts@marronebio.com (530) 750-2800 cell Ex. 6 Personal Privacy (PP) i
From: Beck, Nancy <Beck.Nancy@epa.gov> Sent: Tuesday, January 23, 2018 4:24 PM To: Keith Pitts Cc: Keith Jones; David Beaudreau; Terry Stone; Jeff Blackwood; Keller, Kaitlin; McNally, Robert Subject: RE: Biostimulant Question
Keith, We appreciate your interest in this guidance. The guidance is not yet with OMB. EPA staff are still working on the analyses and documentation. Bob McNally (cc'd above) is the best point of contact at EPA if you would like to engage with EPA on this topic. I'm sure the division would welcome any information, data, or analyses you may have available to inform their work. Also, there is an industrybased biostimulants working group that is coordinated by Lynn Bergeson if you would like to reach out to her as well.
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00039553-00002
Regarding OMB, I think it may be difficult to get traction with them on a document OMB does not have under review. While OMB reviews regulations and guidance documents, they typically do not engage with the Agencies in the development of the documents/analyses themselves, although they do provide overarching guidance (see for example OMB Circular A-4). If you were interested in speaking with OMB, I would suggest you reach out to OIRA within OMB.
Please let me know if you have additional questions.
Best, Nancy
Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 M: Ex. 6 Personal Privacy (PP) beck.nancy@epa.Rov
From: Keith Pitts [mailto:kpitts(5)marronebio.com1 Sent: Friday, January 19, 2018 11:37 AM To: Beck, Nancy <Beck.Nancy@epa.gov> Cc: Keith Jones <ones@bpia.org>; David Beaudreau <dbeaudreau@dclrs.com>; Terry Stone <terry.stone@agrinos.com>; Jeff Blackwood <jeff.blackwood@basf.com> Subject: Biostimulant Question
Nancy, I hope you are well. As you may know, the industry has been working with EPA-BPPD to complete a guidance document that provides clarity about what types of biostimulants fall within the plant growth regulator definition used under FIFRA.
We understand that the guidance document is now with OMB and have been told that OMB may be looking for an economic analysis to support why this guidance document has value to the industry and to the US economy.
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00039553-00003
If this is the case, the industry is willing to work with EPA and OMB to pull together data to support this review. In order to support this effort, if needed, the industry would appreciate an opportunity to discuss, with EPA and OMB, what information would be needed to support moving this guidance forward. The BPPD staff apparently have not had direct contact with OMB, so we do not know who the industry should be reaching out to at OMB to start a discussion about what information would be useful to support the decision-making process.
Could you possibly help us identify the appropriate contact(s) at EPA and OMB to help move this guidance forward?
As always, thank you for your help with this effort. With best wishes, Keith
Keith Pitts Chief Sustainability Officer Senior Vice President-Regulatory and Government Affairs Marrone Bio Innovations 1540 Drew Avenue Davis, CA 95618
kpitts@marronebio.com (530) 750-2800
Ex. 6 Personal Privacy (PP) C e l l
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00039553-00004