Page 1 700 2nd Street NE, Washington, DC 20002 | (202) 249. 7000



### Via Electronic Mail and Certified Mail

June 5, 2015

Paul Lewis Chief, Chemical Information and Testing Branch

Office of Pollution Prevention and Toxics USEPA Headquarters

William Jefferson Clinton Building 1200 Pennsylvania Ave., N

. W

. Washington, DC 20460

Re: Follow Up to May 20, 2015 Teleconference Testing Consent Order for Octamethylcyclotetrasiloxane (D4) CASRN 556

- 67

- 2 40 C.F.R. 799.5000; EPA

- HQ

- OPPT

- 2012

- 0209

Dear Paul :

This letter follows the May 20, 2015, conference call (May 20 th Call) between the Silicones Environmental, Health, and Safety Center ( SEHSC ) and the U.S. Environmental Protection Agency (EPA or Agency) regarding the selection of five wastewater treatment p lants (WWTP) to meet the requirements of Appendix 2 to the D4 Enforceable Consent Agreement (ECA)

. SEHSC, as principal test sponsor for the ECA signatory companies, believes that the Study Plan and supporting materials provided to the Agency demonstrate t hat the WWTP locations proposed for sampling meet the ECA criteria set out in Appendix 2 to the ECA. Accordingly, we trust that EPA will accept those sites and approve the Study Plan and QAPP as soon as possible so that testing program can

move forward at the four direct discharge sites, the five “Primarily Non

- Industrial” WWTPs, and the five “Indirect Discharge” WWTPs proposed for sampling.

During the May 20 th Call and via letter dated May 13, 2015 1 , EPA expressed concern regarding whether certain of the WWTPs proposed for sampling met the ECA criteria for “Indirect Discharge Sites.” Specifically, the Agency questioned whether each Indirect Discharge WWTP proposed for sampling is receiving wastewater from a “known” D4 processor/formulator.

Acc ording to the Appendix 2 to the ECA, for the Indirect Discharge WWTPs:

All wastewater treatment sites selected for monitoring must be currently processing wastewater from one or more industrial sites known to be a D4 processor or formulator as documented through industrial user surveys or by other readily available information. The WWTP influent shall reasonably be expected to contain D4 based on industrial user surveys or other readily available information.

As SEHSC and the Agency have discussed on num erous occasions, the process for identifying, qualifying, and securing the agreement of the WWTPs to participate in this program has been challenging and time

- consuming. SEHSC and the ECA signatory companies do not own, operate, or control the WWTPs. The WWTP owners/operators are not subject to the ECA and are under no obligation to participate in the program. Likewise, the indirect dischargers that send their wastewater to the WWTPs are also not subject to the ECA. Furthermore, in

1 May 13, 2015 Letter from Maria Doa, Ph.D., Director, Chemical Control Division, U.S. Environmental Protection Agency to Karlu ss Thomas, Senior Director, Silicones Environmental, Health, and Safety Center.Page 2 700 2nd Street NE, Washington, DC 20002 | (202) 249. 7000

addition to the crite ria noted above, Appendix 2 to the ECA also specifies that the WWTPs must use activated sludge for treatment and employ no other form of additional treatment other than secondary clarification/disinfection absent EPA agreement ; t he WWTPs may only release t o riverine systems and should have effluent discharge rates that are relatively large when compared to the receiving water body (low dilution) ; and the sites should be in different regions of the country. Together, these factors greatly limit the pool of potential sampling locations.

In light of the above considerations, SEHSC’s contractor engaged in an intensive iterative process to review, qualify, and secure the participation of WWTPs for the program. This process was described in § 2.5.1.2 of t he Draft Study Plan (and in prior meetings/teleconferences with the Agency). As follow up to this process and in response to EPA’s request, a survey instrument was sent to indirect dischargers associated with each proposed

WWTP to obtain additional data t o further validate that the WWTPs met the ECA criteria. Responses to those surveys, which have been provided to the Agency, bolster our contention that each proposed WWTP is receiving

wastewater from one or more industrial sites “known” to be a D4 processor or formulator. During the May 20 th Call, we reviewed the responses for each site and discussed how those responses specifically confirm each WWTP’s eligibility. 2

It bears noting that the ECA anticipates that it may prove challenging to “know” whether an indirect discharger not subject to the ECA is indeed a D4 processor or formulator. Hence, the inclusion of the provision that this may be documented “through industrial user surveys or by other readily available info rmation” and that “WWTP influent shall reasonably be expected to contain D4 based on industrial user surveys or other readily available information.” In this case, survey results, SIC code analysis, and industry knowledge (including, for example, a detail ed description of silicone polymers and their role/usage in various industries) have all been provided to substantiate the proposed WWTPs.

During the May 20 th Call, EPA also raised concerns regarding the scope and meaning of “process” as applied to

sit e selection for the Testing Program. Specifically, EPA questioned whether certain of the indirect dischargers associated with the WWTPs proposed for sampling may be considered to be a “processor” as defined by the Toxic Substances Control Act (TSCA) 3 if a site were “only” processing polymers or other materials containing D4.

We note that the ECA does not define “processor” or “process.” However, as noted in our May 20, 2015 slide deck (and referenced in EPA’ May 13, 2015 letter), TSCA defines the terms quite broadly:

(10) The term “process” means the preparation of a chemical substance or mixture, after its manufacture,

for distribution in commerce

— (A) in the same form or physical state as, or in a different form or physical state from, that in whic h it was received by the person so preparing such substance or mixture, or (B) as part of an article containing the chemical substance or mixture.

(11) The term “processor” means any person who processes a chemical substance or mixture. 4

Moreover, as we noted during the May 20 th Call, the Agency has defined the term “process” or “processor” in a consistent manner in numerous places throughout its TSCA

- implementing regulations:

Process means to process for commercial purposes.

Process for commerci

al purposes means the preparation of a chemical substance or mixture after its manufacture for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical su bstance or mixture is included in this definition. If a chemical substance or mixture containing impurities is processed for commercial purposes, then the impurities also are processed for commercial purposes.

Processor means any person who processes a chemical substance or mixture. 5

2 For the teleconference, we provided a slide deck that summarizes the analysis for each site.

3 15 U.S.C. §§ 2601

– 2692.

4 15 U.S.C. § 2602.

5 40 C.F.R. § 704.3. Similar definitions appear, for example, in 40 C.F.R. §§ 712.3(m), 716.3, 717.3(g), and 721.3.Page 3 700 2nd Street NE, Washington, DC 20002 | (202) 249. 7000

As we highlighted during the May 20 th Call, this definition would squarely encompass the indirect discharge sites associated with the WWTPs proposed for sampling under Appendix 2 to the ECA.

We observe that in instances in which the Agency has decided to limit the scope of the definition of “process” so that a particular regulatory requirement was not applicable to a party that solely processes a given chemical substance as an impurity, it has done so e xplicitly in the corresponding rulemaking. 6 The ECA does not contain any such qualification or limitation and we believe strongly that the proposed WWTPs satisfy the ECA criteria. We believe that their inclusion is consistent with the purposes of the Tes ting Program, particularly given that those sites reflect how D4 is being processed at most industrial facilities throughout the U.S. 7

As we noted during the May 20 th Call and in our prior discussions, delays in approving the Study Plan and QAPP will greatly impact the timing for completion of the Testing Program due to the limited availability of sampling windows at the various locations. SEHSC and the Signatory Companies to the ECA stand ready to move forward with the actual sampling phase of t he Testing Program and look forward to the Agency’s approval of the Study Plan

and QAPP so that mobilization activities can commence.

Please do not hesitate to contact me directly should you have any questions.

Sincerely,

Karluss Thomas

SEHSC Executive Director

cc: Heather Njo (EPA)

6 For example, in TSCA section 4 test rules, the regulatory provision describing who is required to test may provide a carve

- out indicating that all manufacturers and processors of the chemicals substance “other than as an impurity” are subject. See, e.g., 40 C.F.R. 799 .5055.

There would be no need for such a carve

- out if the term process or processor did not encompass such activities.

7 We note that the direct discharge sites that will be sampled per Appendix 1 to the ECA include D4 processors and formulators. A nd, results for those sites will also address processing with D4.