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Ward Penberthy

Deputy Director

Chemical Control Division

OPPT/ U.S. EPA

February 19, 2013

Dear Ward:

Following on our recent discussions and the February 1, 2013, memorandum we received from Jeff Morris 

(EPA) regarding next steps for the Siloxane Enforceable Consent Agreement (ECA) negotiation (Morris 

Memo), the primary purpose of this letter is to formally provide a revised environmental monitoring proposal 

from the member companies of the Silicones Environmental, Health, and Safety Center (SEHSC)1, which we 

hope will lead to the conclusion of the ECA negotiations so that the proposed monitoring program can be 

commenced. Indeed, from the beginning of this process, the SEHSC member companies expressed a 

desire and willingness to generate additional environmental monitoring data. Thus, we are anxious to see 

the ECA negotiation process reach a productive conclusion in an efficient manner so that time and energies 

can be spent on actually collecting/analyzing environmental samples. In that regard, we have some 

questions and concerns about the “Next Steps” set out in the Morris Memo, which we discuss below 

following the summary of our revised proposal. 

Revised Environmental Monitoring Proposal 

SEHSC remains committed to the development of a science-based environmental monitoring program to 

support an ecological risk assessment for D4. As you know, SEHSC has a long history of collaborative 

engagement with regulatory authorities to develop and support risk and safety evaluations for silicone 

materials. Consistent with our commitment to risk-based environmental stewardship, and our desire to bring 

these ECA negotiations to a mutually-agreeable conclusion, we are proposing to modify and augment our 

initial proposal (i.e., the March 1, 2012, letter with attachments from Karluss Thomas to Maria J. Doa, Ph.D.) 

(March 1, 2012 Proposal) to include five (5) additional municipal wastewater treatment plant (POTW) sites in 

the monitoring program set out in Appendix 2 of the March 1, 2012 Proposal. This means that environmental 

monitoring is proposed for a total of ten (10) POTW sites and four (4) SEHSC member company facilities that 

have direct discharges to surface waters. Certain other changes to the March 1, 2012 Proposal as set out in 

 

1

SEHSC is an ACC sector group comprised of the following companies, which were formerly members of the Silicones 

Environmental Health and Safety Council of North America: Bluestar Silicones USA Corporation; Dow Corning Corporation; 

Evonik Goldschmidt Corporation; Milliken & Company; Momentive Performance Materials Inc.; Shin-Etsu Silicones of America, 

Inc.; and Wacker Chemical Corporation.
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slide 3 of the December 6, 2012 presentation offered by SEHSC at the December 6, 2012 Negotiation 

Meeting and in my December 18, 2012 letter to you should also be considered part of the revised proposal.2 

 

We believe adding 5 POTW sites to the proposed monitoring program not only strengthens an already robust 

proposal, but also demonstrates our willingness to compromise in order to bring the negotiations to a 

productive close. Importantly, we will also be continuing our voluntary global product stewardship initiative 

(VPSI) which will provide additional useful environmental monitoring data that will inform a risk assessment 

for D4.

3

Questions/Concerns Regarding Morris Memo

The Morris Memo states that EPA “is developing a risk assessment plan for D4 and plans to have it reviewed 

in a peer consultation.” It also indicates that EPA will seek input from the reviewers on aspects of the 

SEHSC and EPA monitoring proposals and that “[a]dvice from the reviewers on monitoring data needs will 

inform the ECA negotiations.” We are concerned about how such a process fits into the context of the 

present ECA negotiations and how this would improve the outcome of the negotiations. 

We note that the “Procedures for developing consent agreements” established by the Agency and 

promulgated as a rule in 40 C.F.R. § 790.22 do not provide for the inclusion of a peer consultation as part of 

the negotiation process. As provided for under those procedures, interested parties were provided with an 

opportunity at the outset of the ECA negotiation process to declare their interest in participating in the 

negotiations. By design this creates the opportunity for the Agency to receive input from interested parties 

with multiple perspectives on the matter. It does not appear that the inclusion of a peer-consultation would, in 

this case and at this stage of the negotiation process, meaningfully improve the outcome of the ECA 

negotiations. Moreover, it would considerably delay the start of monitoring, with an associated delay of the 

Agency’s plans for developing an ecological risk assessment for D4. 

If the Agency does intend to further extend the ECA negotiations in order to insert a peer-consultation into 

the process—as noted in the Morris Memo—we request that EPA address the following questions/issues 

during the next negotiation meeting:

1. Explain how the peer consultation process fits within the established regulations for developing ECAs, 

including, for example, the timeline, public involvement, and decision making set out in § 790.22.

2. Describe how the Agency envisions the peer consultation process working. 

a. Specifically, describe key steps, milestones, timeline, relationship to ECA and Risk 

Assessment development process.

3. What criteria will the contractor use in selecting the peer consultants?

4. What specific charge will be provided to the peer consultants? 

5. What information will be made available to the peer consultants?

6. What work product will result from the peer consultancy? How and with whom will it be shared?

7. What opportunities will the industry have to provide information on its proposed monitoring plan and 

the scientific justification for it? 

8. What opportunities will the public have to be involved in this process?

* * *

 

2

Specifically, these include elimination of monitoring biota (fish, benthic species) at the POTW sites and air monitoring at one 

POTW site and the elimination of D5 as a substance to be monitored in the program.

3 We have previously provided EPA with information on the VPSI – see Attachment 2 to our March, 1, 2012 letter.
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As we highlighted in our August 3, 2012 letter, SEHSC prepared its March 1, 2012 Proposal in good faith 

based on feedback received from EPA taking into account best available science. We entered the 

negotiations which formally commenced on June 27, 2012 with an understanding that based on its review of 

the proposal EPA believed “that proceeding with the negotiation of a consent agreement is an efficient 

means of developing the data.” To bring these negotiations to a productive and efficient conclusion, we have 

modified our proposal based on Agency feedback, as described herein, and we trust that the Agency will 

carefully consider this revised proposal as well as the concerns highlighted above. 

We look forward to discussing these and other items in more detail during the next negotiation meeting. In 

the meantime, should you have any questions or concerns, please do not hesitate to contact me.

Sincerely,

Karluss Thomas

Senior Director, SEHSC