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Beck, Nancy [/0=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=168ECB5184AC44DE95A913297F353745-BECK, NANCY] 3/8/2018 12:40:34 PM John Doherty!____ ,,____ x. 6_________ j RE: Proposal for the review of epidemiological studies in the open literature
John, Thank you for your emails, and thank you for your years of service and continued dedicated to the Office of Pesticide Programs. I appreciate the feedback and suggestions for improvement from someone who has a history here within our program (and I hope retirement is treating you well!). Things are quite busy in OCSPP thus it takes a while for me to respond to all my emails. I apologize for the delay, but I can assure you your input has been considered by me and also shared with OPP.
As you may recall, our staff has gotten a bit leaner over the past decade, so we are always looking for ways to improve our processes. Since your retirement, OPP has made numerous steps to build in efficiencies and streamline resources across the program, resulting in improvements and time savings in our scientific review processes, including the review of data requirements and studies conducted to support registrations. Just this week, we announced the availability of final test guidelines for antimicrobial pesticides that work against public health microbial pests. Earlier this month, we announced reduced residue chemistry data guidance for seed treatment uses. Though unrelated to your discipline, these are just a few of the recent examples that come to mind of how we making improvements where we can. In the toxicity arena, we have made great strides modernizing the acute toxicity "six-pack" under the Strategic Direction for New Pesticide Testing and Assessment Approaches, expanding our acceptance of alternative testing, avoiding the generation and evaluation of data that does not influence a regulatory decision, and reducing the burdens of animal testing (as well as the number of DERs generated). More broadly, we are working with our Federal partners through ICCVAM to coordinate on several other scientific fronts to ensure pesticide toxicity data generation and evaluation is forward thinking.
Regarding chlorpyrifos, despite the years of study and multiple Scientific Advisory Panels, we have concluded that the science addressing neurodevelopment effects remains unresolved and that further evaluation of the science is warranted during the remaining time for completion of registration review, which must be completed by October 1, 2022. OPP scientists continue to monitor and consider the ongoing research and literature evaluating the potential human health effects for chlorpyrifos. In addition, we continue to consider how best to use the available observational epidemiology data in light of the comments from the FIFRA Scientific Advisory Panel as well as comments received in response to the November 2016 Notice of Data Availability.
I appreciate your thoughts and suggestions and will keep them in mind as we continue to improve our processes and procedures, including those related to the review and consideration of epidemiology and toxicology data. We hear from many stakeholders about these issues and continuous improvement is what we are striving for.
Regards, Nancy
Nancy B. Beck, Ph.D., DABT Deputy Assistant Administrator, OCSPP P: 202-564-1273 M: 202-731-9910 beck.n3ncy@ep3.gov
From: John Doherty
Ex. 6
Sent: Monday, February 26, 2018 4:12 PM
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00050054-00001
To: Beck, Nancy <Beck.Nancy@epa.gov> Subject: Proposal for the review of epidemiological studies in the open literature
Dr. Beck: I was very frustrated with the way things were going with the chlorpyrifos project based on the Columbia study. Attached is a proposal for the review of an epidemiological study that occurs in the open literature so that problems with the study will be identified early in the process. The decisions in the resulting product will be transparent and the individuals responsible (the owners of the decisions) will be identified and the decision defended as needed.
I would really appreciate it if you would read this over and let me know of any comments that you may have.
I have not heard from you on the proposal to increase the efficiency of the review of toxicity studies in OPP to produce a more useful review document which I sent last fall.
If you would like to further discuss either of these two proposals, I would be happy to visit your office.
Thank you for giving my suggestions your consideration.
John D. Doherty, Ph D. (DABT 1982-2017)
Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00050054-00002