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ENFORCEABLE CONSENT AGREEMENT

FOR

ENVIRONMENTAL TESTING FOR

OCTAMETHYLCYCLOTETRASILOXANE (D4) (CASRN 556-67-2)

Docket No. EPA-HQ-OPPT-2012-0209

Available at www.regulations.gov

Date: August 6, 2013

Version: 1F – DRAFT

Contains No Confidential Business Information

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ENFORCEABLE CONSENT AGREEMENT FOR

ENVIRONMENTAL TESTING FOR:

OCTAMETHYLCYCLOTETRASILOXANE (D4) (CASRN 556-67-2)

Docket No. EPA-HQ-OPPT-2012-0209

[COMMENT – TOC WILL NEED UPDATING]

TABLE OF CONTENTS

I. INTRODUCTION.....................................................................................................................................5

II. CHEMICALS SUBJECT TO THE ECA.................................................................................................5

III. OBLIGATIONS OF THE SIGNATORY COMPANIES.......................................................................5

IV. PRINCIPAL TEST SPONSOR..............................................................................................................6

V. PURPOSE OF THE TESTING PROGRAM...........................................................................................6

VI. SCOPE OF THE TESTING PROGRAM...............................................................................................6

VII. DESCRIPTION OF TESTING PROGRAM.........................................................................................6

VIII. STANDARDS FOR CONDUCTING TESTING................................................................................7

IX. SCHEDULE, STUDY PLANS, TESTING, AND REPORTS...............................................................7

X. MODIFICATIONS TO THE ECA........................................................................................................10

XI. FAILURE TO COMPLY WITH ECA.................................................................................................10

XII. EPA MONITORING OF ECA TESTING..........................................................................................10

XIII. SUBMISSIONS TO EPA AND CONFIDENTIALITY OF INFORMATION.................................10

XIV. PUBLICATION AND DISCLOSURE OF TESTING RESULTS....................................................11

XV. OTHER RESPONSIBILITIES OF THE SIGNATORY COMPANIES.............................................11

XVI. RESPONSIBILITY FOR THE ACTIONS OF UNRELATED THIRD PARTIES ..........................11

XIX. SEVERABILITY OF ECA PROVISIONS .......................................................................................12

XX. FINAL AGENCY ACTION ...............................................................................................................12

XXI. PUBLIC RECORD............................................................................................................................12

XXII. EFFECTIVE DATE AND TERM....................................................................................................12

XXIII. RIGHTS OF THE SIGNATORY COMPANIES ...........................................................................13

XXIV. RESERVATION OF RIGHTS BY SIGNATORY COMPANIES.................................................13

XXV. NOTICES.........................................................................................................................................13

XXVI. IDENTITY OF THE SIGNATORY COMPANIES AND PRINCIPAL TEST SPONSOR ..........14

XXVII. SIGNATURES ..............................................................................................................................16

APPENDIX 1..............................................................................................................................................18

APPENDIX 2..............................................................................................................................................21

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APPENDIX 3..............................................................................................................................................24

APPENDIX 4..............................................................................................................................................27

I. INTRODUCTION 

A. Under the authority of Section 4 of the Toxic Substances Control Act (TSCA), 15 U.S.C. § 

2603, and 40 C.F.R. Part 790 of the agency’s implementing regulations, the United States 

Environmental Protection Agency [hereinafter “EPA” or “agency”] and, Dow Corning 

Corporation, Evonik Goldschmidt Corporation, Momentive Performance Materials USA Inc., 

Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation [hereinafter 

individually a “Signatory Company” and collectively “the Signatory Companies”] enter into this 

Enforceable Consent Agreement for certain environmental testing [hereinafter “this ECA”]. As 

used in this ECA, the term “Parties” shall refer jointly to EPA and the Signatory Companies, and 

the term “Party” shall refer individually to one or the other. 

II. CHEMICALS SUBJECT TO THE ECA 

The subject of this ECA is octamethylcyclotetrasiloxane, Chemical Abstracts Service Registry 

Number (CASRN) 556-67-2 [hereinafter referred to as “D4”].

Because this environmental testing program tests for D4 concentrations in the environment, this 

ECA requires testing for D4 in any form found in the environment relevant to the medium being 

sampled

III. OBLIGATIONS OF THE SIGNATORY COMPANIES 

The Signatory Companies are responsible for complying with the terms of this ECA as 

specified herein. The Signatory Companies recognize that to implement this ECA, EPA will 

issue an order under Section 4 of TSCA that incorporates the terms of this ECA. The Signatory 

Companies agree that all terms of this ECA will take effect on the date of publication of the 

notice in the Federal Register announcing the issuance of the Order that incorporates this ECA, 

and all applicable time periods will be treated as beginning on that publication date. 

The Signatory Companies shall submit a draft Study Plan and Quality Assurance Project Plan to 

carry out the environmental testing program set forth in Section VII and Appendices 1, 2, and 3. 

The Signatory Companies shall conduct environmental testing in accordance with the Final 

Study Plan and the Study Plan and Quality Assurance Project Plan (“QAPP”) that will be 

developed based on EPA’s review of the Signatory Companies’ draft submissions. Following 

completion of environmental testing, the Signatory Companies shall submit a Final Report to 

EPA. 

Parts VI through IX provide more details about the testing that will be accomplished under this 

ECA (“Testing Program”).

Comment [A1]: For ECA’s covering toxicity 

testing, a chemical purity is usually specified. Since 

this ECA covers environmental monitoring, this is 

possible alternative language.

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IV. PRINCIPAL TEST SPONSOR

A. To facilitate implementation of the Testing Program, the Signatory Companies have

appointed the Silicones Environmental, Health, and Safety Center (SEHSC), 700 2nd Street NE,

Washington DC 20002, 202-249-7000, as the Principal Test Sponsor of this Testing Program. 

B. The Signatory Companies will provide EPA with written notice should they elect to designate

a different Principal Test Sponsor. 

C. EPA and the Signatory Companies recognize that the Principal Test Sponsor has no legal 

responsibility for complying with this ECA. The role of the Principal Test Sponsor is to assist in 

coordinating and administering testing under this ECA and in communicating with EPA about 

study plans, protocols, analytical methods, schedules, reports, and other aspects of the testing 

program. Responsibility for complying with the ECA rests at all times with the individual 

Signatory Companies. 

V. PURPOSE OF THE TESTING PROGRAM 

The purpose of the Testing Program is to conduct environmental monitoring to characterize

specified sources and pathways of release of D4 to the environment, and resulting exposure of 

aquatic organisms to D4.

Through the Testing Program, the Signatory Companies will develop environmental testing data 

for D4 in the vicinity of manufacturing and processing (including product formulating) sites and

POTWs in the U.S. EPA believes that the Testing Program will generate data needed by the 

agency to assess D4 exposures and risks to sediment and aquatic organisms. 

VI. SCOPE OF THE TESTING PROGRAM

The Testing Program is described in Part VII. Sampling and analysis will be conducted in 

accordance with the test standards described in Part VIII (“Test Standards”) and documented in 

the required submissions described in Part IX.

VII. DESCRIPTION OF TESTING PROGRAM 

A. As described further in Appendix 1 to this ECA, environmental testing will be conducted on 

samples collected at four (4) direct discharge locations operated by certain Signatory Companies. 

For each of the four locations described in Appendix 1, there will be two (2) testing events. In 

particular, each facility’s wastewater treatment plant’s effluent will be sampled and analyzed for 

D4. Sediment, surface water, and biota (benthic and fish species) in the receiving waters will also 

be sampled and analyzed for D4. 

B. As described further in Appendix 2 to this ECA, environmental testing will be conducted on 

samples collected at five (5) POTWs that use activated sludge to treat wastewater from five (5) 

indirect discharge sites. For each of the locations described in Appendix 2, there will be two (2)

testing events involving the collection and analysis for D4 of samples of the following: POTW

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influent, POTW effluent, POTW biosolids, receiving stream surface water, receiving stream 

sediment, and receiving stream biota (benthic and fish species). 

C. As described further in Appendix 3 to this ECA, environmental testing will be conducted on 

samples collected at five (5) POTW locations receiving less than 10% of wastewater from 

industrial facilities and no wastewater from D4 manufacturing processing sites (including 

product formulation) sites

[COMMENT – Selection Criteria, including Precise % To Be Discussed/Confirmed]. For

each of the locations described in Appendix 3, there will be two (2) testing events involving the 

collection and analysis for D4 of samples of the following: POTW influent, POTW effluent, 

POTW biosolids, receiving stream surface water, receiving stream sediment, and receiving 

stream biota (benthic and fish species). 

Following completion of the environmental testing described in paragraphs A-C above, the 

Signatory Companies will provide EPA with a report summarizing the results. 

VIII. STANDARDS FOR CONDUCTING TESTING 

COMMENT – Under Development - Additional Discussion Is Needed Regarding Test 

Standards and Appropriateness for Monitoring Program]

A. The environmental testing shall be conducted in accordance with the Test Standards described 

in Appendix 4 to this ECA.

1. Certain provisions of Test Standards are considered to be mandatory and are referred to as 

“requirements.” These requirements are identified by the use of the words “shall,” “will,” or 

“must” in the text of the Test Standard and delineate a test requirement to be followed or met. 

2. Provisions that are not mandatory, and are therefore only recommended, are identified by the 

use of “should” statements. If such “should” provisions are not followed, the Signatory 

Companies will not be deemed by EPA to be in violation and will not be subject to penalties or 

other enforcement actions and this will not, in and of itself, cause the resulting data to be deemed 

invalid.

B. The Signatory Companies and EPA will consult in good faith to consider the need for Test 

Standard modifications if either EPA or the Signatory Companies desire such modifications. 

Modifications to the Test Standards, if any, will be governed by 40 C.F.R. § 790.68. 

C. All testing required by this ECA shall be in accordance with the EPA Good Laboratory 

Practice (GLP) Standards found at 40 C.F.R. Part 792, except as described in the Study Plan. 

[COMMENT – Further Discussion Is Needed Regarding GLP and Environmental 

Monitoring]

IX. SCHEDULE, STUDY PLANS, TESTING, AND REPORTS

Comment [A2]: This exception is not allowable 

as per EPA regulations: 40 CFR 790.60(a)(7) , 

requiring GLPs.

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The schedule and deliverables for the Testing Program are described below. EPA and the 

Signatory Companies recognize that in some instances modifications to the described schedule 

may be required given the uncertainties (such as weather, sampling/analytical issues, logistics, 

etc.) inherent in performing the field sampling and environmental testing contemplated by this 

Testing Program. Modifications to the schedule, if any, will be made according to the 

procedures set out in 40 C.F.R. 790.68. 

A. Study Plan 

The Signatory Companies will submit a Study Plan prepared pursuant to this ECA to EPA at 

least forty-five (45) days prior to the initiation of testing in accordance with 40 C.F.R. § 790.62

and no more than one hundred twenty (120) days after the effective date of the ECA. The content 

of the Study Plan submitted to EPA will comply with 40 C.F.R. § 790.62(b). Modifications to 

the study plan will be governed by the procedures of 40 C.F.R. § 790.62(c). The Study Plan will 

become part of the official record (docket number EPA-HQ-OPPT-2012-0209). EPA shall 

approve the Study Plan if it meets the requirements of this ECA and 40 C.F.R. § 790.62(b). The 

Study Plan shall become the “Final Study Plan” when approved by EPA. 

The Signatory Companies shall submit a Quality Assurance Project Plan (“QAPP”) to EPA 

within one hundred eighty (180) days of the Effective Date of this ECA and at least forty-five

(45) days prior to the initiation of testing. The QAPP must be prepared in accordance with EPA 

guidance.1 The QAPP shall include complete information on the Test Standards to be used. The 

Test Standards and analytical methods shall achieve analytical limits of detection which are, at a 

minimum, equivalent to the methods that have been used in previous D4 studies [COMMENT –

Further Discussion/Clarification Needed Regarding Studies and Detection Limits]. EPA 

shall approve the QAPP if it meets the requirements of this ECA.

B. Testing

The Testing Program shall commence no more than sixty (60) days after the Study Plan and 

QAPP have been approved by EPA, and testing (i.e., collection and analysis of all samples) shall 

be completed within three hundred sixty (360) days after testing commences, unless the schedule 

is modified, as described above and in Section X.

C. Interim Progress Reports 

The Signatory Companies will submit Interim Progress Reports to EPA informing the agency of 

the progress of the Testing Program. An Interim Progress Report is required one hundred eighty 

(180) days after the Effective Date specified in Part XX.A of this ECA and every one hundred 

eighty (180) days thereafter until the Signatory Companies have fulfilled all obligations under 

Part VII of this ECA. Interim Progress Reports shall include a summary of work completed to 

date, any proposed changes in protocols or schedule, and raw data (as defined in 40 C.F.R. § 

792.3) and any other matters affecting progress of testing. Note: No further reporting is required 

of the Signatory Companies to satisfy any potential reporting obligations that might arise under 

1 EPA Requirements for Quality Assurance Project Plans, EPA QA/G-5, prepared by: Office of Environmental 

Information, EPA (December 2002) - http://www.epa.gov/quality/qs-docs/g5-final.pdf. 

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Section 8(e) of TSCA with respect solely to the data being generated under this ECA once the 

Interim Progress Reports and the Environmental Monitoring Report are submitted to the agency

in accordance with this ECA. 

D. Final Report 

No later than one hundred fifty (150) days following completion of the required environmental 

testing (i.e., collection and analysis of the data), the Signatory Companies shall submit to EPA an

environmental monitoring report (“Final Report”). This Final Report shall include a description 

of monitoring performed, summary of test results, raw data, laboratory analyses, and quality 

assurance/quality control information, as appropriate. 

This Final Report is intended to be released to the public if the Signatory Companies believe that 

any of this information should be submitted under a confidentiality claim, then a confidential 

version should be submitted in accordance with Part XIII of this agreement. However, in such 

event EPA may choose to initiate a review of the confidentiality claim in accordance with EPA 

confidentiality regulations at 40 C.F.R. § 2.306(d) and (e) and Sections 14(a) and 14(b) of 

TSCA, 15 U.S.C. § 2613(a)-(b), in order to ensure that the necessary information is made 

available to the public. 

The Signatory Companies will document all Quality Assurance/Quality Control work done as 

part of the Testing Program. The Signatory Companies will electronically submit all of the raw 

data (as defined in 40 C.F.R. § 792.3) produced during the Testing Program. 

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X. MODIFICATIONS TO THE ECA

Modifications to this ECA, if any, shall be made in accordance with the modification procedures 

contained in 40 C.F.R. § 790.68.

Modifications to any Study Plan under this ECA shall be governed by the procedures of 40 

C.F.R. § 790.62(c). 

XI. FAILURE TO COMPLY WITH ECA 

The Signatory Companies acknowledge that, as specified in 40 C.F.R. § 790.65, a violation 

of this ECA shall constitute a “prohibited act” under section 15(1) of TSCA, 15 U.S.C. § 

2614(1) and shall trigger all provisions applicable to a violation of section 15. In addition, 

noncompliance with this ECA could result in a citizen’s civil action. The Signatory 

Companies further acknowledge that 40 C.F.R. § 790.65 provides additional information 

regarding the implications of failing to comply with an enforceable consent agreement. 

XII. EPA MONITORING OF ECA TESTING

EPA may conduct monitoring activities, such as laboratory inspections and/or study audits, 

of the monitoring, sampling, and/or testing conducted under this ECA in accordance with 

the authority and procedures in Section 11 of TSCA, 15 U.S.C. § 2610. In the event that 

this monitoring contributes to delays in the completion of any activities required under this 

ECA, the parties may seek modification in the scope of testing performed under the consent 

order. 790.68(a). 

XIII. SUBMISSIONS TO EPA AND CONFIDENTIALITY OF INFORMATION

A. All data submitted to EPA under this ECA will be identified by the Docket Number “EPAHQ-OPPT-2012-0209” and the name “Testing Consent Order for Octamethylcyclotetrasiloxane 

(D4) CASRN: 556-67-2.” Six (6) copies of all submissions under this ECA will be provided to 

EPA at the address specified in 40 C.F.R. § 790.5(b).

B. Any document submitted to EPA that contains data or information for which a Signatory 

Company makes a claim of confidentiality shall be submitted as two separate versions. One 

version (the CBI version) shall be complete, with the information being claimed as confidential 

marked in the manner described under 40 C.F.R. § 790.7. The other, public version shall be 

identical in all respects except that all of the information claimed as confidential shall be 

redacted. EPA will place only the public version in the agency’s docket. The complete version 

will be treated in accordance with EPA confidentiality regulations in 40 C.F.R. part 2 and 40 

C.F.R. § 790.7. Data or other information that are considered to be CBI must not be submitted 

electronically to EPA by e-mail. Any part or all of data or other information claimed as CBI must 

be so marked. If the CBI submission is on diskette or CD ROM, the outside of the diskette or CD 

ROM shall be marked as CBI and the specific information that is CBI shall be identified 

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electronically within the diskette or CD ROM. 

C. EPA shall not disclose information marked as CBI except in accordance with procedures set 

forth in 40 C.F.R. part 2 and 40 C.F.R. § 790.7. Any claims of confidentiality for information 

submitted under this Testing Program shall be made under the terms of 40 C.F.R. § 790.7. 

Information claimed as confidential shall be treated in accordance with the procedures in 40 

C.F.R. part 2 and with Section 14 of TSCA, 15 U.S.C. § 2613. If no claim of confidentiality is 

made and substantiated in accordance with 40 C.F.R. § 790.7(c) by the submitter of the 

information at the time of submission, the information will be deemed by EPA, in accordance 

with 40 C.F.R. § 790.7, to be public, and may be made available to the public without further 

notice to the submitter. 

XIV. PUBLICATION AND DISCLOSURE OF TESTING RESULTS 

A. All results of testing conducted pursuant to this ECA shall be announced to the public by EPA 

in accordance with procedures specified in Section 4(d) of TSCA, 15 U.S.C. 2603(d). 

B. Disclosure by EPA of data generated pursuant to this ECA to the public or other government 

agencies shall be governed by Section 14(b) of TSCA, 15 U.S.C. § 2613(b), and 40 C.F.R. Part 

2.

C. Public availability of the Final Report and other data generated pursuant to this ECA is not 

intended to, and does not create an ownership interest or right to use the Final Report, the 

underlying data or other information provided by the Signatory Companies pursuant to this ECA 

for commercial purposes in any entity that is not a Signatory Company.

XV. OTHER RESPONSIBILITIES OF THE SIGNATORY COMPANIES

A. The Signatory Companies are bound by the terms of this ECA and the provisions of 40 C.F.R. 

§ 790.62 and 790.65. 

B. The Signatory Companies will comply with the notification requirements of Section 12(b)(1) 

of TSCA, 15 U.S.C. 2611(b)(1) and 40 C.F.R. § part 707, subpart D, if they export or intend to 

export D4. Any other person who exports or intends to export D4 is subject to the above cited 

export notification requirements.

C. If D4 becomes subject to a rule promulgated under TSCA Section 5(a)(2), 15 U.S.C. 

2604(a)(2), governing significant new uses of D4 then the Signatory Companies will be subject 

to the data submission requirements imposed by section 5(b)(1)(A) of TSCA, 15 U.S.C. 

2604(b)(1)(A), as if the testing under this ECA had been required by a TSCA Section 4 test rule.

XVI. RESPONSIBILITY FOR THE ACTIONS OF UNRELATED THIRD PARTIES 

The Signatory Companies shall make a good faith effort to secure the cooperation of third parties

(such as POTW operators) as needed to complete the Testing Program under this ECA. However 

the Signatory Companies are not responsible for the actions of third parties and shall not be held 

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liable for any inability to secure needed cooperation and/or permission to conduct the 

environmental testing specified under this ECA at locations owned, operated, and/or controlled 

by non-parties to this ECA. 

XVII. FORCE MAJEURE

In keeping with the requirements in 40 CFR 790.68(b)(2), a Signatory Company shall not be 

held liable for any failure to perform its obligations under this ECA that is caused by unforeseen 

circumstances beyond its control or the control of any entity controlled by the Signatory 

Company, including any contractors and subcontractors, that the Signatory Company could not 

have prevented through the exercise of due diligence.

XVIII. DISPUTE RESOLUTION

A. The Parties shall use their best efforts informally and in good faith to resolve any disputes that 

may arise concerning the interpretation or application of the provisions of this ECA, including 

those involving the Study Plan or QAPP. 

XIX. SEVERABILITY OF ECA PROVISIONS 

In the event that one or more provisions of this ECA is determined by a court decision to be 

unenforceable, the remaining provisions of this ECA will not be presumed to be valid, and EPA 

will either initiate a rulemaking proceeding to require testing or publish in the Federal Register 

its reason for not initiating such a proceeding. 

XX. FINAL AGENCY ACTION 

For purposes of 5 U.S.C. § 704, publication of the Federal Register notice announcing the 

issuance of the Order incorporating this ECA constitutes final agency action. 

XXI. PUBLIC RECORD

EPA has established a public record which will contain this ECA, the Order that incorporates this 

ECA, the Federal Register notice announcing issuance of the Order incorporating this ECA, and 

any and all relevant information, subject to the confidentiality provisions of section 14(b) of 

TSCA, 40 C.F.R. part 2, and 40 C.F.R. § 790.7. The official record for this ECA, including the 

public version, which does not include any information claimed as CBI, has been established 

under docket control number EPA-HQ-OPPT-2012-0209.

XXII. EFFECTIVE DATE AND TERM 

A. Effective Date: This ECA takes effect on the date of publication in the Federal Register of the 

notice announcing the issuance of the Order that incorporates this ECA, which shall follow final 

approval and signature of the ECA by the Parties. This ECA may be signed in separate 

counterparts. This ECA will not be effective unless signed by each of the Signatory Companies 

Comment [A3]: EPA is evaluating this language

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and EPA. EPA will codify a reference to the substances in the Testing Program in subpart C of 

40 C.F.R. part 799.

B. Term: Obligations of the Signatory Companies under this ECA, other than record retention 

obligations under 40 C.F.R. § 792.195, as applicable, will cease when any one of the following 

occurs: 

1. The Signatory Companies have provided EPA with all of the deliverables specified under this 

ECA. 

2. A court determines that the relevant provisions of this ECA are unenforceable as described in 

Section XVII of this ECA and 40 C.F.R. 790.60(a)(14). 

3. Non-performance of the specific obligation is excused due to Force Majeure as described in 

Section XVII.

XXIII. RIGHTS OF THE SIGNATORY COMPANIES

By signing this ECA, the Signatory Companies waive their right to challenge EPA’s authority to 

assess penalties for violations of this ECA. This waiver does not affect any other rights that the 

Signatory Companies may have under TSCA with respect to this ECA or to D4 testing beyond 

this ECA, including, but not limited to: 

1. the right to contest whether a violation of this ECA has occurred, 

2. the right to contest the amount of any penalty assessed for alleged violations of this ECA, and 

3. the right to seek judicial review of any administrative enforcement decision pertaining to this 

ECA or of any EPA rule that imposes requirements to test D4. 

XXIV. RESERVATION OF RIGHTS BY SIGNATORY COMPANIES

The Signatory Companies are not admitting that the requirements of Section 4 of TSCA for 

promulgating a test rule to generate the data and information required by this ECA have been 

satisfied The Signatory Companies are also not admitting that Section 4 of TSCA provides EPA 

with authority to require generation of some of the data and information the Signatory 

Companies will provide to EPA through this ECA

XXV. NOTICES

A. Whenever under the terms of this ECA notice is required to be given or a report or other 

document is required to be submitted to a Party, it shall be directed to the individuals and 

addresses specified below, unless otherwise specified in this ECA.

[COMMENT – Need to add contacts, addresses]

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B. Any changes in the individuals or addresses referenced in Section XXV.A of this ECA shall 

be made by written notice to all Parties. 

C. All documents submitted pursuant to this ECA shall be deemed submitted on the date of 

postmark or placed in the hands of a commercial courier service for overnight delivery. Handdelivered documents are deemed submitted upon receipt at the appropriate address specified in 

Section XXV.A, above. Electronically transmitted documents are deemed submitted upon 

transmission. 

XXVI. IDENTITY OF THE SIGNATORY COMPANIES AND PRINCIPAL TEST SPONSOR

A. The Principle Test Sponsor is the Silicones Environmental, Health and Safety Center 

(SEHSC), 700 2nd Street NE Washington DC 20002.

B. The Signatory Companies subject to this ECA are:

[COMMENT - COMPANIES TO UPDATE AS APPROPRIATE]

Dow Corning Corporation

Corporate Center

PO Box 994

Midland, MI 48686

Evonik Goldschmidt Corporation

PO Box 1299

Hopewell, VA 23860

Momentive Performance Materials USA Inc.

260 Hudson River Road

Waterford, NY 12118

Shin-Etsu Silicones of America, Inc.

1150 Damar Drive

Akron, Ohio 44305

Wacker Chemical Corporation

3301 Sutton Road

Adrian, MI 49221

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XXVII. SIGNATURES

[COMMENT – COMPANIES TO UPDATE AS APPROPRIATE]

Each undersigned representative of the Parties to this ECA certifies that he or she is fully authorized by 

the Party represented to enter into the terms and conditions of this ECA and to execute and legally bind 

that Party to it.

Date:_______ ________________________

Jim Jones, Acting Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention

United States Environmental Protection Agency

Date:_______ ________________________

[ Name ], [Title]

Dow Corning Corporation

PO Box 994

Midland, MI 48686

Date:_______ ________________________

[ Name ], [Title]

Evonik Goldschmidt Corporation 

PO Box 1299

Hopewell, VA 23860

Date:_______ ________________________

[ Name ], [Title]

Momentive Performance Materials USA Inc.

260 Hudson River Road

Waterford, NY 12118

Date:_______ ________________________

[ Name ], [Title]

Shin-Etsu Silicones of America, Inc.

1150 Damar Drive

Akron, Ohio 44305

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Date:_______ ________________________

[ Name ], [Title]

Wacker Chemical Corporation

3301 Sutton Road

Adrian, MI 49221

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APPENDIX 1

Environmental Testing at D4 Direct Discharge Sites

Direct discharge sites are D4 manufacturing and/or processing sites that discharge process 

wastewater into the environment after on-site treatment. The four (4) D4 direct discharge sites 

operated by Signatory Companies that directly discharge process wastewater into the 

environment after onsite wastewater treatment that will be monitored for D4 under this ECA are: 

Dow Corning Carrollton Plant 

4770 Highway 42 

East Carrollton, KY 41008 

MPM Silicones, LLC

Waterford Plant 

260 Hudson River Road 

Waterford, NY 12188 

MPM Silicones, LLC

Sistersville Plant 

10851 Energy Highway

Friendly, WV 26146

Wacker Adrian Plant 

3301 Sutton Road 

Adrian, MI 49221

A general process description of the industrial plant operations involving D4 shall be provided. 

A more detailed description, including a written narrative and process flow diagram(s), of the 

wastewater treatment system employed at the sites shall also be provided (e.g., consistent with 

what was provided in each facility’s discharge permit application). At each of these sites, 

wastewater treatment effluent, receiving stream surface water, the receiving stream sediment 

and receiving stream biota shall be sampled and analyzed for D4.

With respect to the wastewater treatment effluent (outfall), sampling is to occur at the 

compliance point in accordance with the facility’s discharge permit (specific IDs will be 

provided in the Study Plan). In addition to the concentration of D4 in the effluent, total 

effluent flow rate shall be recorded and reported.

[SEHSC COMMENT – PLACEHOLDER For Further Discussion/Elaboration 

Regarding Mixing Criteria, Number of Samples, and Basis for Establishing Facility 

Flows/Sample Volumes (e.g., 24-hour composite samples, flow volumes)]

Surface water shall be collected from the receiving water as close as possible to the release 

point provided that adequate mixing of the discharge from the site with the receiving stream 

Comment [A4]: EPA will need to verify that this 

is adequate.

Comment [A5]: EPA believes this needs to be 

clarified in the study plan and similar to sampling 

strategy used in previous studies. Need to provide 

reference(s) to previous studies

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has occurred to allow for uniform distribution. Any variation in sampling location deemed 

necessary and appropriate to accommodate site-specific conditions will be identified in the 

Study Plan.

Surface sediment samples from the receiving water body will be collected as close as possible 

to the wastewater outfall of the release point of the treatment facility. The concentration of D4

in the sediment samples and the water samples will be measured. Any variation in sampling 

location deemed necessary and appropriate to accommodate site-specific conditions will be 

identified in the Study Plan.

Biota sampled shall include benthic species collected in sediment of the receiving water body 

and, if reasonably practicable, two species of fish from different trophic guilds, preferably 

occupying the omnivore and piscivore guilds, if available, in the receiving water body.

The organic content of surface water and sediment samples and the lipid content of biota 

samples shall be measured. 

Samples shall be taken during two testing events at least three (3) months apart. The exact 

duration between sampling events for each site shall be determined in a detailed Sampling Plan

included in the Study Plan. This duration will be of an appropriate length such that these two 

monitoring events may be deemed representative of the annual release of D4 from that site.

Samples shall be collected during normal plant operations and during such times that effluent 

flow rates from the wastewater treatment system are representative of the normal plant 

operations.

Samples shall be taken during typical weather conditions and not until at least three (3) days 

after an unusual weather event such as a heavy rain storm. Samples shall be collected at a time 

when the rate of D4 release is expected to be representative of the typical rate of release of D4 

for that site.

A detailed Sampling Plan shall be prepared for each site and included as part of the Study Plan 

submitted to EPA. The Sampling Plans shall include (with appropriate references to Test 

Standards and/or QAPP): 

• map and detailed description of monitoring locations 

• sampling grids 

• sampling timing and schedule 

• sampling objectives and robust experimental design

• number and type of samples to be collected

• sampling protocols, including loss-free methods for collection, storage, and analysis of 

samples, standard operating procedures

• access requirements 

• site characterization for benthic invertebrate and fish sampling, including the species that 

will be collected for analysis

Comment [A6]: Further discussion needed.

Comment [A7]: Further discussion needed.

Comment [A8]: Further discussion needed.

19
DRAFT

The Study Plan shall provide for the training of sample collection personnel in sampling 

protocols and the special handling requirements associated with D4. In addition, the Study Plan 

shall provide the qualifications of contract laboratory vendor(s) and method validation for all 

matrices to be sampled (e.g., sediment, water, biota).

20
DRAFT

APPENDIX 2

Environmental Testing for Indirect Discharge Sites

Indirect discharge sites are D4 processing sites (including product formulation sites) (or 

formulating) sites that discharge process wastewater to publicly owned treatment works 

(POTWs). Testing shall be conducted for D4 at five (5) POTWs receiving wastewater for 

treatment from D4 processors (including product formulators). A variety of criteria shall be used 

for selecting POTWs receiving D4 from indirect discharge sites:

All sites monitored shall use activated sludge for wastewater treatment.

Consideration should be given to whether the POTW treats other industrial sources of 

wastewater when selecting sites for testing. It is preferable to select sites that treat a 

minimum of wastewater from other industrial sources.

Consideration should be given to sites which serve larger populations and have effluent 

discharge rates (containing D4) that are relatively large when compared to the receiving 

water body’s flow rate (low dilution).

Consideration should be given to geography when selecting sites for testing. 

All sites will release wastewater to riverine systems, the marine (ocean environment).

The Study Plan shall detail the factors that were used to select each of the sites for testing. A 

summary of each POTW’s NPDES permit (e.g., location, industrial inputs, compliance issues, 

changes in facility structure or operation, etc.) as well as a summary of available data on 

historical effluent conditions (e.g., annual flow, dissolved oxygen, temperature, pH, suspended 

solids, biological oxygen demand, etc.) shall be included in the Study Plan. 

A general process description of the industrial plant operations involving D4 shall be provided. 

A more detailed description, including a written narrative and process flow diagram(s), of the 

wastewater treatment system employed at the POTW shall also be provided (e.g., consistent 

with what was provided in each facility’s discharge permit application). 

Prior to including a specific location in the Study Plan, the Signatory Companies shall secure, as 

necessary and appropriate, a letter of cooperation/access from the person with control of the 

location. 

At each of these sites, the POTW influent, POTW effluent, receiving stream surface water, 

receiving stream sediment, biosolids and receiving stream biota shall be sampled and analyzed

for D4. 

[

SEHSC COMMENT – PLACEHOLDER For Further Discussion/Elaboration Regarding 

Mixing Criteria, Number of Samples, and Basis for Establishing Facility Flows/Sample 

Comment [A9]: Further discussion needed.

21
DRAFT

Volumes (e.g., 24-hour composite samples, flow volumes)]

The concentration of D4 in the influent at the headworks of the POTW (i.e., regulated 

compliance point per the POTW’s discharge permit) shall be measured along with the total 

influent flow rate. 

The concentration of D4 in the effluent at the regulated compliance point per the POTW’s 

discharge permit shall be measured along with the total effluent flow rate. 

Surface water shall be collected from the receiving water as close as possible to the release 

point from the treatment facility and measured for the concentration of D4, provided that 

adequate mixing of the discharge from the site with the receiving stream has occurred. Any 

variation in sampling location deemed necessary and appropriate to accommodate site-specific 

conditions will be identified in the Study Plan.

Biosolids samples will be collected [COMMENT – collection point needs discussion and 

clarification]as close to the release point of the treatment facility as possible and the 

concentration of D4 and of the biosolid samples will be measured. 

Surface sediment samples from the receiving water body will be collected as close as possible 

to the wastewater outfall of the treatment facility. Any variation in sampling location deemed 

necessary and appropriate to accommodate site-specific conditions will be identified in the 

Study Plan. The concentration of D4 in the sediment samples will be measured. 

A preliminary evaluation of the receiving waters of any POTW considered for testing shall be 

undertaken to ensure that populations of benthic species and fish are sufficient for meaningful 

sampling. If there are insufficient species, an alternative site shall be selected. Biota sampled 

shall include benthic species collected in sediment of the receiving water body and, if reasonably 

practicable, two species of fish from different trophic guilds, preferably occupying the omnivore 

and piscivore guilds, if available, in the receiving water body.

The organic content of the surface water and sediment samples and the lipid content of biota 

samples shall be measured. 

Samples shall be taken during two testing events at least three (3) months apart. The exact 

duration between sampling events for each site shall be determined by the detailed Sampling 

Plan included in the Study Plan. This duration will be of an appropriate length such that these 

two (2) monitoring events may be deemed representative of the annual release of D4 from that 

site.

Samples shall be collected during normal plant operations and during such times that effluent 

flow rates from the wastewater treatment system are representative of the normal plant 

operations.

Samples shall be taken during typical weather conditions and not until at least three (3) days 

after an unusual weather event such as a heavy rain storm. Samples shall be collected at a time 

Comment [A10]: This needs to be clarified in 

study plan and similar to sampling strategy used in 

previous studies. Need to provide reference(s) to 

previous studies

Comment [A11]: Further discussion needed.

22
DRAFT

when the rate of D4 release is expected to be representative of the typical rate of release of D4 

for that site.

A detailed Sampling Plan shall be prepared for each site and included as part of the Study Plan 

submitted to EPA. The Sampling Plans shall include (with appropriate references to Test 

Standards and/or QAPP): 

• map and detailed description of testing locations 

• sampling grids 

• sampling timing and schedule

• sampling objectives and robust experimental design

• number and type of samples to be collected

• sampling protocols including loss-free methods for collection, storage, and analysis of 

samples, standard operating procedures 

• access requirements 

• site characterization for benthic invertebrate and fish sampling, including the species that 

will be collected for analysis

The Study Plan shall provide for the training of sample collection personnel in sampling 

protocols and the special handling requirements associated with D4. In addition, the Study Plan 

shall provide for the qualifications of contract laboratory vendor(s) and method validation for all 

matrices to be sampled (e.g., water, sediment, biosolids, biota). 

23
DRAFT

APPENDIX 3 

POTWs Not Receiving D4 From Industrial Facilities 

This Appendix addresses D4 testing at publicly owned treatment works (POTWs) that receive

only minor amounts of industrial wastewater. The intent of the testing specified below is to 

develop a greater understanding of environmental releases of D4 emanating from the down-thedrain uses of D4 in various consumer products post-treatment by a POTW. Testing shall be 

conducted for D4 at five (5) POTWs. A variety of criteria shall be used for selecting POTWs 

receiving D4 primarily from consumer sources:

All sites monitored shall use activated sludge for wastewater treatment.

Generally, sites selected for testing shall serve larger populations and have effluent 

discharge rates that are relatively large when compared to the receiving water body’s 

flow rate (low dilution).

The influent to the POTW shall contain less than 10% of waste water from industrial 

sources by volume and no wastewater from D4 manufacturing, processing, or 

formulating sites.[

SEHSC COMMENT – Placeholder for Further Discussion/Confirmation of Site 

Selection Criteria]

Consideration should be given to geography when selecting sites for testing. 

All sites will release their waste water to riverine systems, not marine (ocean)

environments.

The Study Plan shall detail the factors that were used to select each of the sites for testing. A 

summary of each POTW’s NPDES permit (e.g., location, industrial inputs, compliance issues, 

changes in facility structure or operation, etc.) as well as a summary of publicly available data 

on historical effluent conditions (e.g., annual flow, dissolved oxygen, temperature, pH, 

suspended solids, biological oxygen demand, etc.) shall be included in the Study Plan. 

A detailed description, including a written narrative and process flow diagram(s) of the 

wastewater treatment system employed at the POTW shall be provided (e.g., consistent with 

what was provided in a facility’s discharge permit application). 

Prior to including a specific location in the Study Plan, the Signatory Companies shall secure, as 

necessary and appropriate, a letter of cooperation/access from the person with control of the 

location. 

At each of these sites, the POTW influent, POTW effluent, receiving stream surface water, 

biosolids, and receiving stream sediment shall be sampled and analyzed for D4. 

SEHSC [COMMENT – PLACEHOLDER For Further Discussion/Elaboration Regarding 

Comment [A12]: This needs to be clarified in 

the study plan 

24
DRAFT

Mixing Criteria, Number of Samples, and Basis for Establishing Facility Flows/Sample 

Volumes (e.g., 24-hour composite samples, flow volumes)]

The concentration of D4 in the influent at the headworks of the POTW (i.e., regulated 

compliance point per the POTW’s discharge permit) shall be measured along with the total 

influent flow rate. 

The concentration of D4 in the effluent at the regulated compliance point per the POTW’s 

discharge permit shall be measured along with the total effluent flow rate. 

Surface water shall be collected from the receiving water as close as possible to the release 

point from the treatment facility and measured for the concentration of D4, provided that 

adequate mixing of the discharge from the site with the receiving stream has occurred. Any 

variation in sampling location deemed necessary and appropriate to accommodate site-specific 

conditions will be identified in the Study Plan.

Biosolids samples will be collected[COMMENT – collection point needs clarification and the 

concentration of D4 in the biosolid samples will be measured. 

Surface sediment samples from the receiving water body will be collected as close as possible 

to the wastewater outfall release point of the treatment facility Any variation in sampling 

location deemed necessary and appropriate to accommodate site-specific conditions will be 

identified in the Study Plan. The concentration of D4 in the sediment samples will be 

measured. 

A preliminary evaluation of the receiving waters of any POTW considered for testing shall be 

undertaken to ensure that populations of benthic species and fish are sufficient for meaningful 

sampling. If there are insufficient species, an alternative site shall be selected. Biota sampled 

shall include benthic species collected in sediment of the receiving water body and, if reasonably 

practicable, two species of fish from different trophic guilds, preferably occupying the omnivore 

and piscivore guilds, if available, in the receiving water body.

The organic content of the surface water and sediment samples and the lipid content of biota 

samples shall be measured. 

Samples shall be taken during two monitoring events at least three (3) months apart. The exact 

duration between sampling events for each site shall be determined by the detailed Sampling 

Plan included in the Study Plan. This duration will be of an appropriate length such that these 

two monitoring events may be deemed representative of the D4 annual release from that site.

Samples shall be collected during normal plant operations and during such times that effluent 

flow rates from the wastewater treatment system are representative of the normal plant 

operations.

Samples shall be taken during typical weather conditions and not until at least three (3) days 

after an unusual weather event such as a heavy rain storm. Samples shall be collected at a time 

Comment [A13]: This needs to be clarified in 

the study plan and similar to sampling strategy used 

in previous studies. Need to provide reference(s) to 

previous studies. 

Comment [A14]: Discussion needed

Comment [A15]: Two species of fish feeding at 

the same trophic level will not provide information 

regarding biomagnification. The two species 

feeding at different trophic level need to be 

collected to provide information regarding 

biomagnification.

25
DRAFT

when the rate of D4 released is expected to be representative of the typical rate of release of D4 

for that site.

A detailed Sampling Plan shall be prepared for each site and included as part of the Study Plan 

submitted to EPA. The Sampling Plans shall include (with appropriate reference to Test 

Standards and/or QAPP): 

• map and detailed description of testing locations 

• sampling grids 

• sampling timing and schedule 

• sampling objectives and robust experimental design

• number and type of samples to be collected

• sampling protocols, including loss-free methods for collection, storage, and analysis of 

samples, standard operating procedures

• access requirements 

• site characterization for benthic invertebrate and fish sampling, including the species that 

will be collected for analysis

The Study Plan shall provide for the training of sample collection personnel in sampling 

protocols and the special handling requirements associated with D4. In addition, the Study Plan 

shall provide for the qualifying of contract laboratory vendor(s) and method validation for all

matrices to be sampled (e.g., water, sediment, biosolids, biota).

26
DRAFT

APPENDIX 4

[COMMENT – Further Discussion is Required on Test Standards]

Test Standards

Test Standards for use in the environmental monitoring program required by this ECA are listed 

below. Other standards may become available and may be more appropriate for use in this 

program; any modifications to the Test Standards below would be governed by 40 C.F.R. § 

790.68. The Test Standards to be used in the monitoring program shall be specified in the Study 

Plan. All Test Standards shall be adapted so that they are compliant with the EPA Good 

Laboratory Practice (GLP) Standards found at 40 C.F.R. Part 792. 

Influent and effluent collection, sample transfer and analysis

Biosolids collection, sample transfer and analysis:

Sediment collection, sample transfer and analysis:

Benthic Species collection, sample transfer and analysis:

Fish collection, sample transfer and analysis

Comment [A16]: EPA regulations 40 CFR 

790.60(a)(7) require that testing will be conducted 

in accordance with EPA GLP.. In addition, test 

standards must e agreed to and referenced here. 

27