Document ID: EPA-HQ-OPPT-2012-0209-0082
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-03-06T05:00Z

Via CDX and Electronic Mail

January 20, 2015

Mr. Jeff Morris
Deputy Director for Programs
Office of Pollution Prevention and Toxics
USEPA Headquarters
William Jefferson Clinton Building 
1200 Pennsylvania Avenue, N.W. 
Mail Code: 7401M 
Washington, DC 20460

Re:	Request for Schedule Modification  -  Change in Deadline to Submit Study Plan
      Testing Consent Order for Octamethylcyclotetrasiloxane (D4) CASRN:  556-67-2
	40 C.F.R. 799.5000
	EPA-HQ-OPPT-2012-0209

Dear Mr. Morris:

The Silicones Environmental, Health and Safety Center (SEHSC), in its role as Principal Test Sponsor for the Signatory Companies to the Enforceable Consent Agreement for Environmental Testing for Octamethylcyclotetrasiloxane (D4) CASRN:  556-67-2 (ECA), is submitting this written request for modification in the schedule for delivery of the Study Plan to the U.S. Environmental Protection Agency (EPA or Agency) under the ECA.  This submission follows on our prior communications with EPA regarding this matter and is being made pursuant to Section IX of the ECA and 40 C.F.R. 790.68.  

By this letter, SEHSC is formally requesting that the deadline for submission of the Study Plan specified in Section IX.A of the ECA be changed from "no more than one hundred twenty (120) days after the effective date of the ECA" to "no later than February 2, 2015."  As explained further below, we do not believe the requested modification would significantly change the overall schedule for completing the ECA Testing Program.  

Background
In June 2014, SEHSC notified EPA of the challenges it was experiencing in identifying and securing the cooperation of third party wastewater treatment plants (WWTPs) to participate in the Testing Program set out in the ECA.  At that time, SEHSC formally requested that the deadline for submission of the draft Study Plan be extended to April 2, 2015.  SEHSC and representatives of the Signatory Companies met with EPA on July 15, 2014 to discuss the extension request, SEHSC's progress on completing ECA tasks, and opportunities for collaboration between SEHSC and EPA to facilitate completion of the Testing Program.  During the meeting, SEHSC presented data and other information regarding the length of time it had been taking to secure qualified sites.  Following the meeting, SEHSC submitted letters to EPA on July 23, 2014 and on August 1, 2014 which reiterated the extension request.  And, in the interest of keeping the Testing Program moving forward, SEHSC submitted a partial Draft Study Plan to EPA on August 8, 2014 that addressed monitoring at the four direct discharge sites specified in the ECA which are locations controlled by the Signatory Companies.  

EPA notified SEHSC of the Agency's denial of the extension request by letter dated August 18, 2014, which stated that from the Agency's perspective, "SEHSC and the ECA Signatory Companies have had many months to secure WWTP cooperation and it is not clear that a six month delay will, by itself, result in obtaining such cooperation." 

Notwithstanding this denial, SEHSC continued its good faith efforts to secure the cooperation of WWTPs and to move the ECA Testing Program forward.  On October 1, 2014, SEHSC submitted a timely draft Quality Assurance Project Plan (QAPP) and 6-month Interim Progress Report to EPA.  And, it continued to work on securing qualified WWTPs, preparing the pertinent portion of the Study Plan for those sites, and completing other tasks related to the ECA (e.g., laboratory certification, field training, etc.).      

On November 17, 2014, SEHSC and representatives of the ECA Signatory Companies met with EPA to discuss implementation of the ECA.  During the meeting, SEHSC reported that it had been able to secure the cooperation of nine (of the required ten) third party WWTPs.  Based on this progress, SEHSC indicated that it anticipated being able to provide a complete Study Plan and updated QAPP for all sites by February 1, 2015.  In the meeting, EPA expressed a willingness to modify the ECA schedule to accommodate the proposed change in submission date for the complete Study Plan and QAPP.

As follow up to the November 17, 2014 meeting, SEHSC submitted a letter to EPA summarizing the discussions.  This letter reiterated SEHSC's intent to submit a complete Study Plan and update QAPP for ECA sites by February 1, 2015 and noted that SEHSC would be submitting a formal request for a letter of approval from EPA for the schedule change consistent with 40 C.F.R. 790.68.  Importantly, in late December, SEHSC secured the cooperation of a tenth WWTP to meet the requirements of the Testing Program.  This present letter constitutes SEHSC's request for a schedule modification and is based on this progress and the proposed schedule discussed during our November 17 meeting with the Agency.  

Rationale
As detailed in our prior correspondence and meetings with the Agency, the process of identifying and securing the cooperation of third party WWTPs to participate in the ECA Testing Program has been challenging and has taken much longer than what was contemplated at the time the ECA was agreed upon.  Many WWTP operators expressed a reluctance to participate and it has been a time-consuming and labor-intensive process to obtain sufficient data to validate that sites willing to participate potentially meet the criteria specified in the ECA.  In the face of these challenges, the Signatory Companies through their Test Sponsor and contractor have worked diligently and expended significant resources to line up the required number of WWTPs.  With the requisite number of sites now in the fold, efforts are on-going to finalize the Study Plan (and update the QAPP, as appropriate) to address those sites so that the documents can be submitted to the Agency for review by February 2, 2015.    

Importantly, based on our understanding of when targeted sampling conditions will likely exist at the WWTP locations (e.g., low flow, acceptable weather/access, etc.), the requested extension in the deadline for submission of the Study Plan for the ten WWTP locations should not prevent the overall Testing Program from being completed in approximately the same timeframe contemplated by the current ECA.  As discussed during the November 17, 2014 meeting, it is anticipated that all field sampling (i.e., both sampling events required by the ECA) should be completed by the end of Fall 2015 as sampling during winter months would likely not be realistic at many sites.  The approximate time windows for the two sampling events would be May  -  August and September  -  November.  Because the deadline for submitting the QAPP was October 1, 2014 (and the ECA provides EPA with up to 60 days to review), as a practical matter, the first sampling event for the program would be the same (i.e., during the May  -  August 2015 window) under either the original or revised schedule.  It follows that the requested modification would not significantly impact the final reporting deadline of the Testing Program.  Rather, it would assure that the ECA matches practical reality and reflect the significant effort the Signatory Companies have made to obtain third party WWTPs for the Program.  

In light of the foregoing, we respectfully request that the Agency grant this request and provide written acknowledgment of the same.  Should you have any questions or desire further information, please do not hesitate to contact me.

Sincerely,

Karluss Thomas
Sr. Director
			

cc:	Paul Lewis (EPA)
 	Heather Njo (EPA)
	ECA Signatory Companies
	SEHSC legal counsel