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

                      This page intentionally left blank.
                       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	5
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
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").

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 2[nd] Street NE, Washington DC 20002,<PHONE_NUMBER>, 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 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, [COMMENT  -  Further Discussion Is Needed Regarding GLP and Environmental Monitoring]

IX. SCHEDULE, STUDY PLANS, TESTING, AND REPORTS

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. 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 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.

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 "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 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 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 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 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]

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.  Hand-delivered 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 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
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

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

Date:_______                        ________________________
				[    Name     ], [Title]
                        Wacker Chemical Corporation
                        3301 Sutton Road
                        Adrian, MI 49221

                                  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, 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 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

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).

                                  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 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 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).

                                 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-the-drain 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 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 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).
                                  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


[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72185-72186]
[FR Doc No: 2014-28540]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1891]

How To Obtain a Letter From the Food and Drug Administration
Stating That Bioequivalence Study Protocols Contain Safety Protections
Comparable to Applicable Risk Evaluation and Mitigation Strategies for
Reference Listed Drugs; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``How to Obtain
a Letter from FDA Stating that Bioequivalence Study Protocols Contain
Safety Protections Comparable to Applicable REMS for RLD.'' This draft
guidance describes how a prospective abbreviated new drug application
(ANDA) applicant may request a letter stating that FDA has determined
the following: The potential applicant's bioequivalence (BE) study
protocol contains safety protections comparable to those in the risk
evaluation and mitigation strategy (REMS) with elements to assure safe
use (ETASU) applicable to the reference listed drug (RLD) and FDA will
not consider it a violation of the REMS for the RLD sponsor to provide
a sufficient quantity of the RLD to the interested generic firm or its
agent to allow the firm to perform the testing necessary to support its
ANDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 3, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993, 240-402-
7930<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``How to Obtain a Letter from FDA Stating that Bioequivalence
Study Protocols Contain Safety Protections Comparable to Applicable
REMS for RLD.'' Section 505-1(a)(1) of the FD&C Act authorizes FDA to
require applicants to submit a proposed REMS as a part of the relevant
application \1\ if FDA determines that a REMS is necessary to ensure
that the benefits of a drug outweigh its risks (21 U.S.C. 355-1(a)(1)).
A REMS is a required risk management plan that uses tools beyond
routine professional labeling (such as a medication guide, a patient
package insert, and/or a communication plan) to ensure that the
benefits of a drug outweigh its risks (section 505-1(f) of the FD&C
Act). In addition, FDA may require ETASU in some circumstances when
such elements are necessary to mitigate the risks associated with the
drug. ETASU may include, for example, requirements that health care
providers who prescribe or administer the drug have particular training
or certification; that patients using the drug be monitored and/or
enrolled in a registry; or that pharmacies, practitioners, or health
care settings that dispense the drug be specially certified.
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    \1\ Section 505-1 of the FD&C Act applies to any application for
approval of a prescription drug submitted under section 505(b) or
(j) of the FD&C Act (including both NDAs submitted under section
505(b)(2) and ANDAs submitted under section 505(j)), as well as
applications submitted under section 351 of the Public Health
Service Act (42 U.S.C. 262).
---------------------------------------------------------------------------

    FDA is aware of instances in which an RLD sponsor has refused to
sell drug products to a prospective ANDA applicant seeking to conduct
the testing needed to obtain approval, and the RLD sponsor has cited
the REMS ETASU as justification. In the interest of facilitating
prospective generic applicants' access to RLD products to conduct the
testing necessary to support ANDA approval, FDA has, on request,
reviewed the BE study protocols proposed by a prospective ANDA

applicant to assess whether they provide safety protections comparable
to those in the applicable REMS ETASU. When the Agency has determined
that comparable protections existed, FDA has issued letters to the RLD
sponsor stating so, and indicating that FDA would not consider it to be
a violation of the REMS for the RLD sponsor to provide drug product to
the prospective ANDA applicant or its agent.
    Requesting or obtaining such a letter from FDA is not a legal
requirement. If a prospective ANDA applicant chooses to request such a
letter, this guidance is intended to clarify the process for doing so.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the Agency's current thinking on how a prospective generic applicant
can obtain a letter stating that its BE study protocols contain safety
protections comparable to those in the applicable REMS for the RLD. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28540 Filed 12-4-14; 8:45 am]
BILLING CODE 4164-01-P