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ENFORC E ABLE CONSENT AGREEME NT
FOR
ENVIRONMENTAL TESTING FOR
OCTAMETHYLCYCLOTETRA SILOXANE (D4) (CASRN 556

- 67

- 2)

Docket No. EPA

- HQ

- OPPT

- 2012

- 0209

Available at www.regulations.gov

Date: August 6, 2013
Version: 1 F

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Contains No Confidential Business Information

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This page intentionally left blank.

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ENFORC E ABLE CONSENT AGREEME NT FOR
ENVIRONMENTAL TESTI N G FOR:
OCTAMETHYLCYCLOTETRA SILOXANE (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

XX IV. 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 S ection 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 “ a gency” ] and , Dow Corning Corporation, Evonik Goldschmidt Corporation, Momentive Performance Materials USA Inc.,
Shin

- Etsu Silicones of America, Inc., and Wacker Chemical Corporation [her einafter individually a “ Signatory Company” and collectively “the Signatory Companies”] enter into this Enforceable Consent Agreement for certain e nvironmental t esting [hereinafter “this ECA”]

. As used in this ECA, the term “Parties” shall refer jointly t o 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 o ctamethylcyclotetrasiloxane, Chemical Abstracts Service Registry

Number ( CASRN ) 556

- 67

- 2 [hereinafter referred to as “D4”]

.

Because this environmental testing program tests for D4 concentration s 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 S ection 4 of TSCA tha t 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 F ederal R egister announcing the issuance of the Order that incorporates this ECA, and all applic able 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 Compan ies ’ draft subm ission s

. 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 appoint ed the Silicones Environmental, Health, and Safety Center ( SEHSC )

, 700 2 nd 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 lega l 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 monitorin g 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

POTW s in the U.S. EPA believes that the T esting P rogram will generate data needed by the

agency to assess D4 exposures and risks to sediment and aquatic organism s

.

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 C ompanies

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

. In particular, each facilit y ’ 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 f ive (5) POTW s th at use activated sludge to treat waste water 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 s urface 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 facilit ies 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 paragra ph s 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 delinea te 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 dee med by EPA to be in violation and will not be subject to penalties or

other enforcement actions and th is will not , in and of itself, cause th e 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 mad e 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 Pro ject 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 comple te information on the T est S tandards to be used. The

T est S tandards 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 af ter the Study Plan and QAPP ha ve b een 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. A n 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 t hereafter 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 report ing 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 200 2 )

- http://www.epa.gov/quality/qs

- docs/g5

- final.pdf

.

8DRAFT

S ection 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 a ccordance with this ECA.

D

. Final Report

No later than one hundred fifty ( 15 0 ) days following completion of the required e nvironmental testing ( i.e. , collection and analysis of the d ata), the Signatory Companies shall submit to EPA a n

e nvironmental m onitoring r eport (“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 th e public i f 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 choos e 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 S ections 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 Q uality A ssurance /Q uality C ontrol work done as part of the T esting P rogram

. The Signatory Companies will electronically sub mit all of the raw data ( as defined in 40 C.F.R. § 792.3 ) produced during the T esting P rogram

.

9DRAFT

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 b e 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 a dditional 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 labo ratory 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

EC A, 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 “ EPA

HQ

- 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 confidenti al 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 doc ket

. 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

10DRAFT

electronically w ithin 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 S ection 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 m ay 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 procedure s 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 S ection 14(b) of TSCA, 15 U.S.C. § 2613(b), and 40 C.F.R. Part

2.

C. Publ ic 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 p ursuant to this ECA for commercial purposes in any entity that is not a Signatory Company.

XV. OTHER RESPONS I BILITIES 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 S ection 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 int ends to export D4 is subject to the above cited export notification requirements.

C. If D4 becomes subject to a rule promulgated under TSCA S ection 5(a)(2), 15 U.S.C. 2604(a)(2), governing significant new uses of D4 then the Signatory Companies will be su bject 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 S ection 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

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

11DRAFT

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

c ircumstances 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

.

X IX

. 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 p roceeding to require testing or publish in the Federal Register

its reason for not initiating such a proceeding.

X X . FINAL AGENCY ACTION

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

issuance of the Order inc orporating this ECA constitutes final agency action.

XX I . 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 E CA, 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

.

X X II . EFFECTIVE DATE AND TERM

A. Effective Date : This ECA takes effect on the date of publi cation 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

1 2DRAFT

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 EC A, other than record retention obligations under 40 C.F.R. § 792.1 9 5, 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 XVI I.

XX I II . 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 fo r 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.

XXI V . RESERVATION OF RIGHTS BY SIGNATORY COMPANIES

The Signatory Companies are not admitting that the requirements of S ection 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 o f 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]

13DRAFT

B. Any changes in the individuals or address es referenced in Section XXV.A of this ECA shall be made by written notice to all Parties.

C. A ll 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. Hand

delivered documents are deemed submitted upon receipt at the appropriate address specified in

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

transmission.

XX V I . IDENTITY OF THE SIGNATORY COMPANIES AND PRINCIPAL TEST SPONSOR

A. The Principle Test Sponsor is the Silicones Environmental, Health and Safety Center (SEHSC), 700 2 nd 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

H opewell, 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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15DRAFT

XXV I I . 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 Si licones of America, Inc.

1150 Damar Drive Akron, Ohio 44305

16DRAFT

Date:_______ ________________________

[ Name ], [Title] Wacker Chemical Corporation

3301 Sutton Road Adrian, MI 49221

17DRAFT

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 receivi ng 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 C riteria
, 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 adequ ate 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

18DRAFT

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

. T he concentration of D4

in the sediment samples and the water samples will b e 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

o ccupying the omnivore and p iscivore 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 P lan 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 pl ant 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 un usual 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 sit e and included as part of the Study Plan

submitted to EPA

. The Sampling Plans shall include (with appropriate reference s 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.

19DRAFT

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 m ethod validation for all

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

.

20DRAFT

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 p ublicly o wned t reatment w orks (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 ar e relatively large when compared to the receiving

water bod y’ 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 w hat 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 eff luent, 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 d iscussion needed.

21DRAFT

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 coll ected 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

variati on 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 relea se 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. T he concentration of D4 in the sediment samples will be measure d.

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

undertaken to ensur e th at 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 b y 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 weathe r conditions and not until at least three (3) days

after an un usual 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 d iscussion needed.

22DRAFT

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

for that si te.

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 s 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 , standa rd 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 sa mpling 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 )

.

23DRAFT

APPENDIX 3

POTW s Not Receiving D4 From Industrial Facilities

This Appendix addresses D4 testing at p ublicly o wned t reatment w orks (POTWs) that receive only minor amounts of industrial wastewater . The intent of the testing specified below is to develop a greater understanding of environmental release s of D4 emanating from the down

- the

drain use s of D4 in various consumer products post

- treatment by a POTW. Testing shall be conducted for D4 at five (5) POTWs. A variety of cri teria 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

dischar ge rates that are relatively large when compared to the receiving water bod y’ 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 relea se 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 d ata on historical effluent conditions ( e.g. , annual flow, di s solved 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

l ocation.

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

24DRAFT

M ixing 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.

Sur face 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 r eceiving stream ha s 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 waste water outfall release point of the treatment facility Any variation in samplin g location deemed necessary and appropriate to accommodate site

- specific conditions will be identified in the Study Plan. T he concentration of D4 in the sediment samples will be

measured.

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

undertaken to ensure th at 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 bent hic species collected in sediment of the rec eiving water body and , if reasonably practicable, two spec ies 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 s ite 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 un usual 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 infor mation regarding biomagnification. The two species feeding at different trophic level need to be collected to provide information regarding biomagnification.

25DRAFT

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

• samplin g 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 protocol s 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).

26DRAFT

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 be come available and may be more appropriate for use in this

program ; any m odifications 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 analysi s:

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