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Green, Joseph J. [JGreen@KelleyDrye.com] 3/19/2018 6:52:05 PM Willis, Kristen [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=0b437bee32204a51aed37522b09153f3-Willis, Kri] Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy]; Pease, Anita [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=dbbef4b4951144499885d4cdf88d46d0-Anita Pease] Antimicrobial Copper Clinical Trial Expert Panel Review - BioBurden Claims and Panel Review of Infection Related Claims Proposed timeline for CDA Claim Review 1-31-2018.docx
Hi Kristen -
Thanks for the response related to the bioburden reduction claims. W e have some thoughts on the points raised in your message as well as with respect to the status of the panel review for infection-related claims.
(1) Bioburden claims - reference to "clinical triis" and "conducted in ICU rooms"
As discussed previously and indicated in our correspondence, the ability to reference the facts that the claims are based on the results of a ciinical trial, and that those triis occurred in hospital ICUs, are fundamental and critical. They are not optional as we made clear in our prior discussions. W e are surprised that it would be necessary to obtain independent expert panel confirmation of these facts. It is indisputable that the study was a "ciinical trial" and involved patients in the intensive care units of the three hospitals. These facts are easily verified, including by review of the journal articles published with respect to the study.
If ERA feels it necessary to seek expert confirmation of these facts, it would seem that such verification can be obtained easily in a simple question or two and should not extend the panel review period or time schedule. We do not see the need for expert panel confirmation of the fact that the studies involved evaluation of hospital ICU rooms.
If the review you indicate is more than that, please let us know immediately.
Please send us the draft panel review questions by March 30, as indicated.
We propose that ERA allow CDA to proceed without delay with filing amendments (as discussed previously using the FRIA A570 process with a 4 month review period) to allow for the bioburden reduction claims Including reference to the fact that they are based on the results of clinical trials involving hospital ICU rooms, if somehow the expert panel raises questions about the validity of the clinical trial, then we can review those claims at that time, imposing additional delay, however, to confirm these facts does not seem reasonable.
(2) Bioburden claims - DoD funding reference
With regard to the issue of referencing DoD funding of the study we would submit the requested funding verification documentation with the A570 PRIA application noted above, and would modify the claims to reflect the suggested qualifier.
(3) Status of Panel Review of Infection-Related Claims
When we spoke in January, ERA was preparing to finalize the panel review questions and cover letter/information to send to the panel reviewers. (We also were supposed to receive a copy of that final cover letter.) According to the attached timeline provided on January 31, the package was supposed to be sent to
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prospective reviewers within 2-4 weeks (during February). Has that occurred? If not, we see no reason why it should not proceed immediately.
Whiie we understand that there remains a question as to the need for HSRB review, referral to the HSRB, according to the attached timeline, was to occur after receiving panel reviewer input. Accordingly, any delays related to obtaining ethics-related information for the HSRB review analysis should not be delaying initiation of the panei review,
(4) Ethics-related information
We understand that the Medical University of South Caroiina (MUSC) has compiled most, if not a!l, of the requested ethics-related information. However, the decision to release the information to ERA now lies with the hospital general counsel and review boards. We believe that Sloan-Kettering also is compiling the information.
Please let me know if you would like to have a call to discuss.
Regards, Joe
JOSEPH J, GREEN Special Counsel Kelley Drye & Warren LLP (202)'342-8349 jGreen@KeIieyDrye.com Counsel to the Copper Development Association
From: Willis, Kristen [mailto:Willis.Kristen@epa.gov] Sent: Monday, March 19, 2018 9:27 AM To: Green, Joseph J. <JGreen@KelleyDrye.com> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
Good Morning Joe, I want to provide an update to you with regard to the bioburden reduction claims. We have finally received a response
from our OGC with regard to the proposed claim language for bioburden reduction "[The results of a clinical trial] [sponsored by the Department of Defense] [conducted in the intensive care units of three hospitals][has shown that] Use of Antimicrobial Copper touch surfaces [continuously]..."
1) Study funded by- On our last call we had let you know that "sponsored by the Department of Defense" would not be permitted as a label claim but offered "funded by" or "partially funded by" as a possible alternative. Our OGC said that this would be fine but had the following qualifications: i. A copy of the funding agreement or similar documentation should be submitted to demonstrate that the study was funded by/partially funded by the Department of Defense. ii. The claim should be qualified with a qualifier similar to that in the published study "The views, opinions, and/or findings presented here are ours and should not be construed as an official position of the U.S. Department of the Army."
2) OGC recommended that for the claim to reference a clinical trial or "conducted in the ICU" we seek external review rather than review internally. If CDA desires these claims we will send a separate set of questions out along with the HAI questions. To that end, we will be prepared to share these questions with you no later than the end of next week (March 30th). Please advise if this is the path CDA would like to pursue. Alternatively, EPA will review internally with the caveat that references to a clinical study or ICU will not be permitted.
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Thanks, Kristen Willis
Kristen Willis, PhD Senior Scientist Product Science Branch Antimicrobials Division, OCSPP Environmental Protection Agency
Office: 703-347-0515 Ex. 6
From: Willis, Kristen Sent: Wednesday, February 21, 2018 5:22 PM To: 'Green, Joseph J.' <JGreen@ KeIIey Drye.com> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
Hi Joe, Thanks for checking in. I checked in with OGC yesterday and they said they are still working on the bioburden claim
issue and should have a follow up soon. The train is definitely still moving.
Thanks! Kristen
From: Green, Joseph J. [mailto:JGreen@KellevDrye.com1 Sent: Tuesday, February 20, 2018 12:39 PM To: Willis, Kristen <Wiyis.Krisfen@epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
Hi Kristen -
Wanted to follow to see, in particular, where the bioburden claims issue stands. W e do not want to lose momentum on that issue while we sort out the HSRB issues re: the infection-related claims.
Thanks again, Joe
JOSEPH J. OREEH Special Counsel Kelley Drye & Warren LLP (202)' 342-8349 JGreen@KeHeyDrye.com
From: Green, Joseph J. Sent: Wednesday, January 31, 2018 4:54 PM To: 'Willis, Kristen' <Willis.Krisfen@epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
Hi Kristen: Thanks for sending the timeline and for the call today. W e appreciated the agency providing options for evaluation of the bioburden claims and a timeline for review of the HAi-related daims.
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As a follow up, I thought we would send some further information related to the bioburden claims and need for HSRB review.
(1) BioBurden claims: As initially proposed, the basic claims would be preceded by the following statement (bracketed text is optionai):
"[The results of a clinical trial] [sponsored by the Department of Defense] [conducted in the intensive care units of three hospita!s][has shown that] Use of Antimicrobial Copper touch surfaces [continuously] ..." (the full originally proposed claims text is provided below for reference)
We do not object to changing the reference to "clinical trial" to "study" in the first phrase.
We also understood that use of the term "sponsored by the Department of Defense" could be construed as an endorsement by a federal agency. W e considered changing the term "sponsored" to "funded" or some similar language that would not connote "endorsement" but would convey the factual information that the study underlying the bioburden claims was conducted under the auspices of and funded by the Department of Defense. Being able to make such a statement is important to convey that the study was conducted and overseen by an independent third party, it also reflects the fact that information provided on the studies that support the claims will clearly indicate that the Department of Defense was involved with the stud (e.g,, if the study articles were posted on CDA's website, for example, which would be appropriate if the claims are approved). W e are happy to consider alternative language that the agency may suggest, but it is imperative that CDA be able to state that the study was funded and overseen by DoD or, at minimum, an independent third party.
Similarly, it is critical that CDA be able to include in claims a statement about where and how the study was conducted, including that it was "conducted in the intensive care units of three hospitals." This statement provides context for the basic claims language that otherwise would be rendered relatively meaningless given that CDA already has approval for claims that involve greater than 99.9% reduction of bacteria based on laboratory data. The fact that the new claims are based on real world data from a hospital study is the critical element of the claim . Accordingly, we believe it is very important to keep this portion of the bracketed text.
(2) HSRB Review: In laying out the proposed 15 month timeline for review and potential approval of the HAIrelated claims, at least half of that time is consumed by an HSRB review that we believe is unnecessary and would be duplicative of similar reviews already conducted by the Department of Defense and the institutional review boards (IRBs) of the participating hospitals. The purpose of the HSRB review is to make sure that the testing protocol is appropriate for studies involving intentional human exposure and consistent with the Federal Policy for the Protection of Human Subjects of Research (the "Common Rule"). Such a protocol review was performed by the DoD as well as the hospital IRBs, each of which included evaluation to ensure compliance with the Common Rule and, furthermore, to exclude pregnant or nursing women and children from the study. Requiring a separate EPA HSRB review would be duplicative and is unnecessary in light of past agency practice.
For reference, here is an excerpt from the final DOD study report referencing the IRB approvals:
Protocols required to initiate Phase III (the Clinical Trial to determine the effectiveness of copper touch surfaces in preventing the transmission of the monitored microbes from touch surfaces to patients and from patients to touch surfaces in the selected patient care settings) were also developed, approved by each hospital Institutional Review Board (IRB) as well as the with the U.S. Army Medical Research and Materiel Command (USAMRMC), Office of Research Protections (ORP), Human Research Protection Office (HRPO).
The HRPO log number for the trial was A-14315.3a if that is at all helpful. See this link for a summary of the Army HRPO review process of research protocols that was completed for the trial: https://heaith.mil/IVjiSitarv-
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HeaSth-TQp ic s /P riv a c y-a n d -C iv il-U b e rtie s /P ro te c t-H u m a n s -in -R e s e a rc h /H R F Q -R e v ie w -o f-R e s e a rc h -P rQ to c o S s . In addition, I have attached the IRB review report from the Medical University of South Carolina, which was involved in the study.
In other contexts, including DoD testing of insect repellents, EPA has recognized that DoD protocol review is an adequate substitute in lieu of the EPA HSRB review. The same recognition should be accorded here. This is particularly true given that the evaluation of the performance of antimicrobial copper surface materials, unlike insect repellents, does not involve application of the copper materia! to humans (rather, the copper alloys are applied to environmental materials). In fact, EPA also has recognized that HSRB review is unnecessary in situations where people are involved in the study but not the subject to which the pesticidal material is applied. For example, the Antimicrobials Division has found that HSRB review was not necessary in evaluating a study of the efficacy of poo! treatment chemicals where people would be in the pooi (and a source of contamination). Likewise, with the copper alloy studies, the treatment (copperization of surface materials) is applied to the environment and not the patients themselves. The HAI data from the studies reflect an observation made as a result of people being in an environment where copper alloys are prevalent (similar to the evaluation of bacteria loadings in the pool), but the patients are not being treated with copper directly or intentionaliy. Accordingly, the copper studies do not involve intentional exposure to humans and, therefore, HSRB review is not necessary.*
* For example, as EPA described in the Federal Register preamble to 2013 amendments to the regulations governing Protections for Subjects in Human Research Involving Pesticides, the rules apply to "research with pesticides involving infentionat exposure of human subjects and to persons who submit the results of human research with pesticides to EPA." (emphasis added)
in sum, we think that HSRB review is unnecessary given that the copper studies do not involve intentional exposure of human subjects to copper (the pooi chemical precedent). However, if such review were deemed necessary, then EPA should recognize that an equivalent review has been conducted by the DoD and hospital IRBs and that these reviews are an adequate substitute for the EPA HSRB process, at least in this case, as the Office of Pesticides has previously determined with respect to prior DoD studies involving insect repellants, To require an extra HSRB review, adding another 6-8+ months to the timeline, is unreasonable.
Thank you for your consideration of these issues. W e look forward to resolving these and moving forward as rapidly as possible with the substantive pane! review of the copper studies.
Regards, Joe
JOSEPH J, GREEN Specs! Counsel Kelley Drye A Warren LLP (202) 342-8849 jGreen@KelleyDrye.com
Bio-Burden Reduction Claims
[The results of a clinical trial] [sponsored by the Department of Defense] [conducted in the intensive care units of three hospitals][has shown that] Use of Antimicrobial Copper touch surfaces [continuously] - reduces the level of [Gram +/ Gram -] bacteria in healthcare facilities - results in >80% average reduction in the level of [Gram +/ Gram -] bacteria. - reduces bacteria by >80%. - delivers continuous and ongoing antibacterial action, remaining effective in killing >80% of bacteria. - help inhibit the buildup and growth of bacteria between routine cleanings and sanitizing steps. - reduces the bacterial load in healthcare settings. - delivers [more than][>] 80% reduction of bacteria on this surface [throughout the day].
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- reduces bacteria in healthcare settings. - delivers continous antibacterial action. - inhibits the buildup and growth of bacteria between cleanings. - inhibits the growth of bacteria during active patient care.
JOSEPH J, GREEN
Special Counsel Kefley Drye & Warren LLP (202)' 342-8849 jGreen@KeileyDrye.com
From: Willis, Kristen [m ailto:W illis.Kristen@ epa.govl Sent: Wednesday, January 31, 2018 4:28 PM To: Green, Joseph J. <jGreen@ KejieyDrye.com > Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Joe, Thanks again for the call today. While we are working on answers to the follow up questions, attached is the proposed
timeline for review of claims that we discussed on our call this afternoon. I will follow up soon.
Thanks, Kristen
From: Green, Joseph J. [mailto:JGreen@KeneyPrve.com1 Sent: Wednesday, January 31, 2018 1:36 PM To: Willis, Kristen <Willis.Kristen@epa,gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Kristen -
Here are the issues we would like to discuss (based on last week's call);
How ERA will handle bioburden claims separately and CDA's request to proceed with a label amendment application
Status/timing of ERA cover letter to reviewers and CDA request to review draft Confirm list of all materials to be sent to reviewers (assumes no bioburden review)
o Cover letter o ERA white paper on standard public health claims AD review process o Charge questions o Salgado manuscript o Raw data file for HAIs and password o Raw data roadmap (will need to send revised version that does not include bioburden) Review timeline and urgency to get this started
Thanks Joe
JOSEPH J. GREEN
Spedai Counsel
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From: Willis, Kristen [mailto:Willis.Kristen(Sepa.aovl Sent: Wednesday, January 31, 2018 12:39 PM To: Green, Joseph J. <JGreen@Keliev Drve.com> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Joe, Confirmed.
Thanks! -Kristen
From: Green, Joseph J. [mailto:JGreen@KeneyDrve.com1 Sent: Wednesday, January 31, 2018 12:38 PM To: Willis, Kristen <Wiliis. Krisfen@epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Kristen - Just confirming that we are on for our call at 2:00 today. Call-in below. Thanks again Joe
JO SEPH J, GREEN
Special Counsel Kelley Drye & Warren LLP (202) 342-8849 jGreen@KeiieyDrye.corn
From: Green, Joseph J. Sent: Wednesday, January 24, 2018 11:41 AM To: 'Willis, Kristen' <Wiilis.Knsten@epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Kristen - 2pm Wednesday 1/31 works best for us. Alternative would be 11am that day. We can use the same call-in info as before if that works for you:
Dial +1 (877) 472 4353 Guest Dial-in Code: 2418684#
Let me now when we are confirmed.
Thanks Joe
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From: Willis, Kristen [m ailto:W illis.Kristen@ epa.govl Sent: Tuesday, January 23, 2018 2:25 PM To: Green, Joseph J. <JGreen@KejieyDrye.com> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Joe, I looked for a time this week that was good for everyone however unfortunately I couldn't find anything. Haley is out
the beginning of next week. As such I would propose the following times:
Wednesday 1/31 at 11am or 2pm Or Thursday 02/01 at 11am
Let me know if any of those work for you.
Thanks, Kristen
From: Green, Joseph J. [mailto:JGreen@KeneyDrye.com1 Sent: Tuesday, January 23, 2018 11:40 AM To: Willis, Kristen <W iliis.Kristen@ epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Kristen - CDA is good with the revised charge questions as attached, assuming we come to a satisfactory consensus on how the bioburden reduction claims will be handled, if so, then these questions are appropriate for the pane! to consider.
Thanks and Set me know what dates/times look good for a cali later this week.
Regards, Joe
JOSEPH J. GREER Special Counsel Kelley Drye & Warren LLP (202) 3420849 3Green@KeiieyDrye.com
From: Willis, Kristen [mailto:Wiltis.Kristen@epa.gov1 Sent: Monday, January 22, 2018 4:24 PM To: Green, Joseph J. <JGreen@KelleyDrye.com> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Joe, Thanks for the great call and for the quick turnaround in sending the claims. We also felt it was very productive. As
discussed, I have attached a copy of the draft charge questions with the changes we discussed. Please note that former questions 19, 24a, 27 and 28 have been removed from this draft. As discussed, we will revisit the issue of removal of these questions at our follow up call after we have had time to review the information provided. I'm still working on getting some times/dates for our next call. I will follow up with you tomorrow.
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Thanks! -Kristen
From: Green, Joseph J. [niailtodG reenfgKeliayDrve.eornl Sent: Monday, January 22, 2018 3:12 PM To: Willis, Kristen <W inis.Kristen@ epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review (bioburden)
Hi Kristen -
Thanks again for the cail today, which we thought was very productive and helpful. Foilowing up, I'm forwarding the proposed bioburden reduction claims (see "bio-burden reduction" section of attached document and below). As discussed, CDA would be amenable to excluding the bioburden issues from the panel review process, if in fact EPA confirms, as suggested on the call, that these claims can be reviewed and approved by the agency in an expeditious manner. On the call, it was mentioned that EPA already has approved similar claims based on the existing efficacy data that supports the current registration or Antimicrobial Copper Alloys. If EPA confirms that no panel input is needed for EPA review of the bioburden claims, my sense is that we could proceed with a label amendment application at this time.
Such an amendment appiication presumably would fail under PRiA category A570, with a 4 month review period and application fee of $3831. https://www.epa.gov/pria-fees/a570-pria-fee-category
Please let me know what you think. W e look forward to discussing later in the week.
Regards, Joe
JOSEPH J, GREEN Special Counsel Kelley Drye & Warren LLP (202)'342-8349 8Green@KelleyDrye.com
Bio-Burden Reduction Claims
[The results of a clinical trial] [sponsored by the Department of Defense] [conducted in the intensive care units of three hospitals][has shown that] Use of Antimicrobial Copper touch surfaces [continuously] -- reduces the level of [Gram +/ Gram -] bacteria in healthcare facilities -- results in >80% average reduction in the level of [Gram +/ Gram -] bacteria. -- reduces bacteria by >80%. -- delivers continuous and ongoing antibacterial action, remaining effective in killing >80% of bacteria. -- help inhibit the buildup and growth of bacteria between routine cleanings and sanitizing steps. -- reduces the bacterial load in healthcare settings. -- delivers [more than][>] 80% reduction of bacteria on this surface [throughout the day]. -- reduces bacteria in healthcare settings. -- delivers continous antibacterial action. -- inhibits the buildup and growth of bacteria between cleanings. -- inhibits the growth of bacteria during active patient care.
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From: Willis, Kristen [m ailto:W illis.Kristen@ epa.govl Sent: Friday, January 19, 2018 2:38 PM To: Green, Joseph J. <JGreen@KejieyDrye.com> Cc: Weiss, Steven <Weiss.Steven@epa.gov>; Hebert, John <HehertJohn@epa.gQy> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
Hi Joe, That is correct. In the event of a shutdown (fingers crossed it doesn't happen) the call will not occur.
Here are a few alternate dates/times that may work depending on how long the shutdown lasts: Thursday 0 1/25/2 018- lpm Wednesday 01/31/2018- 11am or lpm
Just FYI, once a shutdown commences I won't have access to my work email so won't be able to confirm any of the alternate dates/times until after the shutdown is over. Hopefully it won't come to that but just in case! -Kristen
From: Green, Joseph J. [mailto:JGreen@KeneyDrye.com1 Sent: Friday, January 19, 2018 9:03 AM To: Willis, Kristen <W iliis.Kristen@ epa.gov> Cc: Weiss, Steven <Weiss.Steven@epa.gov>; Hebert, John <HebertJohn@ epa.gov> Subject: Re: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
Hi Kristen - so, figured I'd touch base in case the shutdown goes ahead. If that occurs I assume, obviously, that the call would not occur. (Though correct me if I'm wrong!). With that in mind, are there some alternate dates/times - later in week? Following week? - that we could shift too? Let me know what you think. Regards Joe
On Jan 17, 2018, at 3:16 PM, Willis, Kristen <WiHis,Kristen@epa,gov> wrote:
Hi Joe, The topics you have proposed sound good. We don't have any additional specific issues. If you could
provide a call in number that would be great as we are currently going through a revamp of our teleconference system.
Thanks, Kristen
From: Green, Joseph J. [m ailto:JGreen@Kelley Drye.com1 Sent: Wednesday, January 17, 2018 2:58 PM To: Willis, Kristen <W illis.Kristen@ epa.gov> Cc: Weiss, Steven <Weiss,Steven@ep3.gov>; Hebert, John <H ebertJohn@epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
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Monday the 22nd at 2:00 pm works best for us. If there are any specific issues you can point in advance for us to discuss, that would be helpful. In addition, we thought the following topics would be helpful to address:
? Cover letter and other materials to be sent to potential reviewers ? Inclusion of CDA reviewer candidates ? Clarification that both bioburden and infection reduction claims are part of the review ? Schedule/timeline - feedback on schedule proposed by CDA
i can set up a call number if you like, or if there is a system that works better for you, let me know.
Thanks again Joe
JOSEPH J, GREEN Special Counsel Kelley Drye & Warren LLP (202)'342-8849 JGreen@KeIleyDrye.com
From: Willis, Kristen [m ailto:Willis.Kristen@epa.gov1 Sent: Wednesday, January 17, 2018 1:34 PM To: Green, Joseph J. <JGreen@Kelley Drye.com > Cc: Weiss, Steven <Weiss,Steven@epa.gev>; Hebert, John <HebertJQhn@epa.gQv> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
Hi Joe, AD would like to set up a call with CDA to discuss the feedback on the questions. In order to expedite
this process, would any of the following dates/times work? Thursday 1/18 at lpm Monday 1/22 at 2pm
Alternate date: Friday 1/19 at 11am.
Regards, Kristen Willis
Kristen Willis, PhD Senior Scientist Product Science Branch Antimicrobials Division Office of Chemical Safety and Pollution Prevention Environmental Protection Agency
Office:. 70.3-347.-0.515
Ex. 6
Physical Address One Potomac Yard 2777 Crystal Dr. Arlington, VA 22202
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From: Green, Joseph J. [mailtoJGreemgKeliayDrye.eornl Sent: Friday, January 05, 2018 10:02 AM To: Hebert, John <H8barfJohn@epa.gov> Cc: Weiss, Steven <Weiss.Steven@epa.gov>; Keigwin, Richard <Keigwin.Richard@epa.Rov>; Hughes, Hayley <hughes.havlev@epa.gov>; Willis, Kristen <Wilii$.Knsten@epa.gov>: Beck, Nancy <Beck, Nancy@epa.gov> Subject: RE: Draft Charge Questions - Antimicrobial Copper Clinical Trial Expert Panel Review
Hi John -
Thanks again for sending the draft charge questions. In the attached letter and red-line document, CDA has a few suggestions on the questions and some recommendations for moving forward, including a suggested timeline to help maintain progress in getting the review of the copper clinical trial underway and completed. We do hope that the process can get started in the next week or so (by January 15) with sending out the initial communication from EPA to prospective panel members, as noted in our Setter. To that end, I will be forwarding a suggested cover Setter in the next day or so.
Please let us know if you have any questions or need any additional information, and keep us posted on how things proceed.
Also, best wishes with the new posting. W e have appreciated working with you and look forward to continuing to do so.
Regards, Joe
JOSEPH J. GREER Special Counsel Kelley Drye & Warren LLP Washington Harbour3050 K Street NW, Suite 400 Washington, DC 20007 Tel: (202) 342-8849 3Green@KeileyDrye.com
WWW.KELLEYDRYE,COM
From: Hebert, John [mailto:Hebert.John@epa.gov1 Sent: Friday, December 15, 2017 3:52 PM To: Green, Joseph J. <jGreen@KelievDrye.com> Cc: Weiss, Steven <Weiss,5teven@epa.gov>; Keigwin, Richard <Keigw in.Kichard@ep3.gov>; Hughes, Hayley <hughes.hayley@epa.gov>; Willis, Kristen <Willis.Kristen@epa.gov> Subject: Draft Charge Questions
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Hello Joe - Please see the attached draft charge questions. Along with charge questions, we intend to provide our federal partners with a white paper that describes the general registration process including efficacy data requirements for products making public health claims. Please let me know if you have any questions.
Regards, John
John Hebert, Chief Registration Management Branch I Antimicrobials Division Office of Pesticide Programs Environmental Protection Agency (703) 308-6249 hebertjohn@ epa.gov
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This E-mail message and any attachments have been scanned for viruses and are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened. However, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Kelley Drye & Warren LLP for any loss or damage arising in any way from its use.
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00046591-00013
The information contained in this E-mail message is privileged, confidential, and may be protected from disclosure; please be aware that any other use, printing, copying, disclosure or dissemination of this communication may be subject to legal restriction or sanction. If you think that you have received this E-mail message in error, please reply to the sender.
This E-mail message and any attachments have been scanned for viruses and are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened. However, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Kelley Drye & Warren LLP for any loss or damage arising in any way from its use.
The information contained in this E-mail message is privileged, confidential, and may be protected from disclosure; please be aware that any other use, printing, copying, disclosure or dissemination of this communication may be subject to legal restriction or sanction. If you think that you have received this E-mail message in error, please reply to the sender.
This E-mail message and any attachments have been scanned for viruses and are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened. However, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Kelley Drye & Warren LLP for any loss or damage arising in any way from its use.
The information contained in this E-mail message is privileged, confidential, and may be protected from disclosure; please be aware that any other use, printing, copying, disclosure or dissemination of this communication may be subject to legal restriction or sanction. If you think that you have received this E-mail message in error, please reply to the sender.
This E-mail message and any attachments have been scanned for viruses and are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened. However, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Kelley Drye & Warren LLP for any loss or damage arising in any way from its use.
The information contained in this E-mail message is privileged, confidential, and may be protected from disclosure; please be aware that any other use, printing, copying, disclosure or dissemination of this communication may be subject to legal restriction or sanction. If you think that you have received this E-mail message in error, please reply to the sender.
This E-mail message and any attachments have been scanned for viruses and are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened. However, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Kelley Drye & Warren LLP for any loss or damage arising in any way from its use.
This message is subject to Kelley Drye & Warren LLP's email communication policy.
K D W -D i sel ai m er
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00046591-00014