UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C

. 20460

Ms. Barbara Glenn Science and Regulatory Affairs Croplife America 1156 151h 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 meetin gs as soon as they become available and provide them for inclusion 

### in the pu blic 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 reflectedin 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 tim ing of the May and July SAP meetings, the topics that w ill be brought before the two SAP reviews are not directly dependent. The July SAP is intended to provide the Age ncy 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 t ime to factor the impact of such a recommendation within the proposed WoE evaluation methodology. Consistent with ensu ring 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

2cc: Steven Knott (7201 M) Steven Bradbury (7501 P) Laura Bailey (7201 M) Mary Manibusan (7201 M)

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