UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Ms. Barbara Glenn 

Science and Regulatory Affairs 

Croplife America 

1156 151

h Street, N.W. 

Washington, D.C. 20005 

Mr. Michael P. Walls 

Regulatory & Technical Affairs 

American Chemistry Council 

700 Second St., NE 

Washington, DC 20002 

Dear Ms. Glenn and Mr. Walls, 

OFFICE OF CHEMICAL SAFETY ANO POLLUTION PREVENTION 

May 20, 2013 

Thank you for the letter of May 8, 2013, expressing your concerns about EPA's 

FIFRA Scientific Advisory Panel (SAP) Public Meetings on the Endocrine Disrupter 

Screening Program (EDSP) scheduled for May 21-23, 2013, June 25-28, 2013 and July 

30-August 2, 2013. In the letter, you request that the agency focus on the opportunity 

for meaningful public review and comment and robust independent scientific peer 

review relative to the aforementioned EDSP SAP meetings. 

We share your concerns that there be adequate transparency and opportunity 

for public engagement. Under our long-standing SAP practices, we have developed 

practices to assure a very open and participative process. While EPA encourages 

written comments be submitted from the date of publication of the meeting notice in the 

Federal Register to approximately 14 days prior to the meeting, written comments are 

accepted until the day of the meeting. This current SAP practice allows ample 

opportunity for public review and comment, which the agency considers important to the 

SAP independent peer review process and transparency around the topics considered 

by the SAP. 

Under our SAP practices, we disseminate the agency documents in support of 

FIFRA SAP meetings as soon as they become available and provide them for inclusion 

in the public docket. For the May SAP meeting, the documents were transmitted to the 

SAP office on April 23, 2013 and were publicly available on April 24, 2013 (as reflected 
in regulations.gov). I would note that the Federal Register notice for the June SAP 

meeting contains a statement that needs clarification. While the notice indicates that all 

documents will be available approximately 15 days prior to the meeting, typically the 

substantive background materials and charge questions are available earlier (in this 

case they are anticipated to be released in early June). The draft meeting agendas are 

typically available approximately 15 days prior to meetings. 

While we recognize the close timing of the May and July SAP meetings, the 

topics that will be brought before the two SAP reviews are not directly dependent. The 

July SAP is intended to provide the Agency feedback on WoE methodology to 

determine whether or not a chemical has the potential to interact with the estrogen, 

androgen and/or thyroid systems based on Tier 1 data and any available OSRI. The 

Panel will not be addressing proposed conclusions for any given chemical, but rather 

providing advice to the Agency as to a WoE methodology that can be applied to data 

sets with varying quality and relevance for this specific intended purpose. Since the 

July WoE is designed to provide feedback on approaches for integrating data from 

diverse sources, with their associated uncertainties, it is not directly dependent on the 

specific results of the May SAP. However, should it appear that the recommendations 

from the May meeting will help inform the July SAP; e.g if the SAP concludes at the 

close of the May meeting a specific assay is unnecessary in the Tier 1 battery, there will 

be ample time to factor the impact of such a recommendation within the proposed WoE 

evaluation methodology. 

Consistent with ensuring an open and transparent process, the Endocrine 

Disrupter Screening Program issued its Comprehensive Management Plan in June 

2012. In this management plan, the program provided specific activities associated 

with review of the Tier 1 assay and battery performance and weight of evidence 

assessments in 2013. As the program moves forward, we will continue such 

communications to our public stakeholders and regulated community. 

I hope that these clarifications address your concerns. Please contact Steven 

Knott, Acting Director, Office of Science Coordination and Policy, if you have additional 

questions (202-564-8430; knott.steven@epa.gov). 

Sincerely, 

nes, Acting Assi nt Administrator 

of Chemical Safety and Pollution 

Prevention 

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cc: Steven Knott (7201 M) 

Steven Bradbury (7501 P) 

Laura Bailey (7201 M) 

Mary Manibusan (7201 M) 

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