Exhibit 1

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1 APPENDIX A

2 TO CONSENT AGREEMENT AND FINAL ORDER

3 FLUOROTELOMER-BASED PRODUCT BIODEGRADATION TESTING

4 SUPPLEMENTAL ENVIRONMENTAL PROJECT

5

6 I. OVERVIEW OF FLUOROTELOMER-BASED POLYMER PRODUCT

7 BIODEGRADATION TESTING SUPPLEMENTAL ENVIRONMENTAL

8 PROJECT

9

10 A. This document, Appendix A, describes the Fluorotelomer-Based Product 

11 Biodegradation Testing Supplemental Environmental Project (“Biodegradation SEP”) that 

12 Respondent, E. I. du Pont de Nemours and Company (“DuPont”) has agreed to perform pursuant 

13 to Section III of the Consent Agreement and Final Order (“CAFO”) in TSCA-HQ-2004-0016, 

14 et al., entered into between DuPont and the United States Environmental Protection Agency 

15 (“EPA” or “Agency”) (collectively, “the parties”). This Appendix describes the SEP activities 

16 that DuPont will conduct to the extent that applicable funding allows.

17 B. In compliance with, and in addition to, the requirements of the CAFO, DuPont, 

18 shall (1) comply with the requirements of this Appendix and Attachments A-H, and (2) require 

19 any entity that DuPont contracts with to fulfill DuPont’s obligations under this SEP, to comply 

20 with the requirements of this Appendix and Attachments A-H.

21 C. Purpose and Background. The purpose of this Biodegradation SEP is to 

22 determine the degradation potential of the nine commercial fluorotelomer-based products 

23 identified in Attachment A to this Appendix (“the Fluorotelomer Products” or “Fluorotelomer 

24 Products”) as well as the degradation potential of corresponding synthesized or purified 

25 polymers equivalent to the Fluorotelomer Products with respect to the chemical composition 

26 that creates their fluorotelomer functionality (“Corresponding Polymers”). Eight of the nine 
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1 Fluorotelomer Products to be tested under this Biodegradation SEP are fluorotelomer-based 

2 polymers, while the ninth is a fluorotelomer-based phosphate ester. The Fluorotelomer 

3 Products are products that were sold by DuPont prior to the date DuPont signs the Consent 

4 Agreement, and that DuPont will provide as the chemical substances to be tested pursuant to 

5 this Biodegradation SEP. An understanding of the degradation potential of the Fluorotelomer 

6 Products will be developed by considering the results of semi-continuous activated sludge 

7 (SCAS) studies. Accordingly, this Biodegradation SEP is designed to provide information on 

8 the inherent biodegradation potential of the Fluorotelomer Products and their Corresponding 

9 Polymers using SCAS.

10 The modified SCAS test is an inherent biodegradability study in which the test 

11 substance is exposed to activated sludge microorganisms in an aerated, aqueous medium with 

12 periodic settling of the solids and renewal of the aqueous phase with fresh media and test 

13 substance. The laboratory will run the test for twelve (12) weeks and will measure analytes 

14 that are indicative of degradation by determining the amount and rate of formation of 

15 observed degradation product(s) in the aqueous, sludge, and gas phases. Performing SCAS 

16 on the Purified Fluorotelomer Products and then comparing the results to the same study 

17 performed on one or more of their Corresponding Polymers will enable a close look at the 

18 potential aerobic biodegradation of the Fluorotelomer Products. 

19 D. Use and Functionality of Fluorotelomer Products. Fluorotelomer products are 

20 used widely in a range of commercial applications, including some that are directly released 

21 into the environment, such as fire fighting foams, as well as soil, stain, and grease resistant 

22 coatings on carpets, textiles, paper, and leather. Fluorotelomer products are aqueous 

23 dispersions. They originate from fluorotelomer iodides [F(CF2CF2)n-I; where n= 3,4,5 
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1 commonly] which are commercially made by reacting pentafluoroethyl iodide with 

2 tetrafluoroethylene to create even-number-carbon polyfluoroalky iodides. Although the 

3 telomerization process can be used to produce odd-number-carbon raw materials, those are not 

4 intentionally made or sold by DuPont.

5 Fluorotelomer iodides are functionalized to create a series of fluorotelomer raw 

6 materials [including other fluorotelomer iodides [F-(CF2-CF2)n-CH2-CH2-I, n = 3,4,5 

7 commonly] and fluorotelomer alcohols [F-(CF2-CF2)n-CH2-CH2-OH, n = 2,3,4,5 etc.] that are 

8 then appended to an organic or inorganic moiety that contains the fluorotelomer as a functional 

9 group. As an example, fluorotelomer acrylate monomers [F-(CF2-CF2)n-CH2-CH2-O-C(O)-

10 CH=CH2, n = 3,4,5 commonly] are copolymerized with one or more of a group of 

11 hydrocarbon monomers to create an acrylic polymer with fluorotelomer functionality. The 

12 most common fluorotelomer raw material used in DuPont’s fluorotelomer products is the 

13 family of fluorotelomer alcohols. These alcohols are generally further transformed into 

14 polymeric and non-polymeric fluorotelomer-based products. This Biodegradation SEP 

15 involves the testing of polymeric and non-polymeric fluorotelomer products based on these 

16 common fluorotelomer intermediates; any reference in this Biodegradation SEP to DuPont’s 

17 commercial Fluorotelomer Products and their Corresponding Polymers is a reference to both 

18 the polymeric and non-polymeric products.

19 DuPont generally manufactures product concentrates as aqueous dispersions of 

20 fluorotelomer products that are sold to industrial customers who dilute, formulate, and blend the

21 fluorotelomer products. These customers then either apply these new formulations to finished 

22 articles or sell them to other customers who apply them to finished articles. In this way, the 

23 DuPont commercial Fluorotelomer Products being tested as part of this Biodegradation SEP 
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1 are thus analogous to paint concentrates and the finished articles to a cured paint surface. 

2 Evaluations of these biodegradation studies carried out on DuPont’s Fluorotelomer Products 

3 for the purpose of attempting to assess the biodegradation potential of cured fluorotelomer4 based polymer products would need to be carefully done given the differences between the 

5 cured and uncured fluorotelomer-based products. Substances made with fluorotelomer 

6 functionality should not be referred to as either “perfluorinated” or “fluoropolymers” as these 

7 terms describe other materials.

8 E. As part of this Biodegradation SEP, DuPont will:

9 1. Provide sufficient quantities, as described in Sections II.D-E below, of 

10 DuPont’s nine Fluorotelomer Products, listed in Attachment A.

11 2. Prepare the following chemical substances (referred to collectively as 

12 “Corresponding Polymers”).

13 a. A purified polymer that is prepared in accordance with this 

14 Appendix Attachment H – Purification Procedure Agreement (PPA) for each of the 

15 Fluorotelomer Products listed in Attachment A (“Purified Fluorotelomer Product”). DuPont 

16 and EPA have agreed on the procedure(s) that DuPont will use to purify the Fluorotelomer 

17 Products to produce the Purified Fluorotelomer Products, taking into consideration the need to 

18 optimize various factors, including the appropriate duration of extraction and redispersion 

19 processes, the desired purity of the Purified Fluorotelomer Products, the schedule for delivery 

20 of the Purified Fluorotelomer Products to the laboratories for characterization, testing and 

21 studies, and the overall schedule for completing this Biodegradation SEP. The PPA represents 

22 the agreement reached between EPA and DuPont concerning the procedure to be used to 

23 produce the Purified Fluorotelomer Products. Reporting on the production of the Purified 
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1 Fluorotelomer Products shall be in accordance with the reporting provisions of the PPA.

2 b. A synthesized fluorotelomer product containing a purified 

3 polymer, comparable to the Fluorotelomer Product for which it corresponds, that is prepared in 

4 the laboratory using production plant raw materials (“Synthesized Fluorotelomer Product”).

5 c. A synthesized fluorotelomer product containing a purified 

6 polymer, comparable to the Purified Fluorotelomer Product for which it corresponds, that is 

7 prepared in the laboratory using high purity raw materials (“Lab-scale Synthesized 

8 Fluorotelomer Product”).

9 3. Timing of Test Substance Transfer.

10 a. Within thirty (30) days of entering into a contract with (1) the 

11 laboratory performing biodegradation and (2) the laboratory performing characterization, 

12 DuPont shall transfer the sufficient quantities, as described in Sections II.D, below, of the nine

13 Fluorotelomer Products to such laboratories.

14 b. Within thirty (30) days of entering into a contract with (1) the 

15 laboratory performing biodegradation and (2) the laboratory performing characterization, 

16 DuPont shall transfer the sufficient quantities, as described in Sections II.D of the 

17 Corresponding Polymers, identified on Attachment A for pilot testing, to such laboratories.

18 c. DuPont shall transfer sufficient quantities, as described in Sections 

19 II.D, of the Corresponding Polymers that EPA selects for biodegradation studies to such 

20 laboratories to timely commence characterization and the biodegradation studies as required in

21 each laboratory’s EPA-approved work plan.

22 d. The timing for transfer of test substances to EPA is set forth in 

23 Section II.E., below.
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1 4. Third Party Laboratory Contract: Characterization. Contract with a 

2 Third Party Laboratory (“laboratory”) to characterize the Fluorotelomer Products, their 

3 Corresponding Polymers identified in Attachment A for pilot testing, and any of their 

4 Corresponding Polymers selected by EPA for biodegradation studies according to Attachment B 

5 parameters to help inform the results of the biodegradation studies. The characterization of 

6 these Fluorotelomer Products and Corresponding Polymers, discussed in greater detail in 

7 Attachment B, will determine, using the most accurate instrumentation and procedures 

8 available as of the time of testing, and the best achievable precision, the amount of residual 

9 monomers and oligomers, other residuals, and the molecular weight distribution of polymeric 

10 material in the Fluorotelomer Products and Corresponding Polymers. 

11 a. The Characterization Laboratory shall commit to the following 

12 timeline for characterization if the solvent selected is tetrahydrofuran (THF), for which a 

13 validation protocol was submitted to EPA in August 2011:

14 1. Report the results of method validation no later than forty15 five (45) days after the validation protocol submitted to EPA in August 2011 has been approved 

16 by EPA.

17 2. Submit the final characterization protocol no later than five 

18 (5) days after the method validation results in subsection 4.a.1. above have been submitted.

19 3. Submit the final characterization report with the Certificate 

20 of Analysis no later than thirty-five (35) days after EPA approves the final characterization 

21 protocol in subsection 4.a.2. above.

22 b. The Characterization Laboratory shall commit to the following 

23 timeline for characterization if the solvent selected is methyl tert-butyl ether (MTBE):
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1 1. Revise and submit to EPA the validation characterization 

2 protocol no later than three (3) days of EPA deciding MTBE should be used for 

3 characterization.

4 2. Report the results of method validation no later than 

5 twenty-one (21) days after EPA approves the validation characterization protocol of 

6 subsection 4.b.1. above.

7 3. Submit the final characterization protocol no later than five 

8 (5) days after the method validation results in subsection 4.b.2. above have been submitted.

9 4. Submit the final characterization report with the Certificate 

10 of Analysis no later than thirty-five (35) days after EPA approves the final characterization 

11 protocol in subsection 4.b.3. above.

12 5. Third Party Laboratory Contract: Biodegradation. Contract with a 

13 Third Party Laboratory (“laboratory”) to:

14 a. Pilot test the Purified Fluorotelomer Products and Corresponding 

15 Polymers, as identified in Attachment A, following study guidelines for modified semi16 continuous activated sludge (SCAS). SCAS pilot testing shall begin by the laboratory no later 

17 than January 31, 2010.

18 b. Submit the final SCAS analytical method development plan by 

19 January 20, 2012. 

20 c. Submit the final SCAS analytical validation protocol no later than 

21 thirty (30) days after EPA approval of the results from implementation of the EPA-approved 

22 SCAS analytical method development plan of subsection 5.b. above. Within thirty (30) days 

23 after approval of the results from implementation of the EPA-approved SCAS analytical 
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1 validation protocol, the Biodegradation Laboratory shall measure analytes from two (2) 

2 replicate trial run time zero samples from each of three (3) separate test substance dosed SCAS 

3 units for a total of six (6) replicate samples for one or both variants as described in Section 

4 II.M., below, and submit results. Subsections 5.d.-5.g. below shall be implemented only if the 

5 EPA approves the trial run results.

6 d. Submit the final SCAS study protocol no later than fourteen (14) 

7 days after EPA approval of the trial run results of subsection 5.c. above.

8 e. Submit the SCAS QAPP no later than fourteen (14) days after 

9 EPA approval of the final SCAS study protocol of subsection 5.d. above. 

10 f. Perform SCAS studies on the Purified Fluorotelomer Products and 

11 any Corresponding Polymers selected by EPA to be used in the biodegradation studies.

12 g. Subject to section II.M. below, the laboratory will conduct the 

13 SCAS studies on the Purified Fluorotelomer Products and any of their Corresponding 

14 Polymers in order to investigate the degradation potential of these Fluorotelomer Products to 

15 produce perfluorooctanoic acid (PFOA) or other analytes identified in Attachment C, and to 

16 determine the potential, if any, for their Corresponding Polymers to degrade to form PFOA or 

17 other analytes identified in Attachment C. The SCAS testing shall begin within thirty (30) 

18 days after the EPA approval of the final SCAS QAPP of subsection 5.e. above.

19 6. Panel Administrator Contract. Contract with an independent third party 

20 (“Panel Administrator”) to implement and administer the Peer Consultation process under this 

21 Biodegradation SEP. As discussed in greater detail in Section V, a Peer Consultation Panel 

22 will be involved in this Biodegradation SEP at specified milestones.

23 F. Applicability of Results. Because this Biodegradation SEP is designed to 
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1 examine (1) the inherent biodegradation potential of the Fluorotelomer Products and their 

2 Corresponding Polymers and (2) the biodegradation potential and fate of the Fluorotelomer 

3 Products and their Corresponding Polymers under aerobic sewage treatment plant simulation 

4 conditions, it does not address the biodegradation potential of the Fluorotelomer Products or 

5 their Corresponding Polymers in soil, sediments, landfills, or aquatic or marine systems, nor 

6 does it address degradation under anaerobic conditions. Additionally, using the results of this 

7 Biodegradation SEP to attempt to assess the biodegradation potential of cured polymers would 

8 need to be carefully done given the differences between cured and uncured fluorotelomer9 based products.

10 Inherent biodegradability tests are designed to assess whether a substance has any 

11 potential for biodegradation. According to OECD Guidance on the Use of the Globally 

12 Harmonized System for the Classification of Chemicals which are Hazardous for the Aquatic 

13 Environment (April 2001), a positive result in an inherent biodegradation test indicates that the 

14 test substance will not persist indefinitely in the environment; however, rapid and complete 

15 biodegradation cannot be assumed. A negative result in an inherent biodegradation test does 

16 not definitively demonstrate that a chemical will not biodegrade under any conditions, but rather 

17 that the chemical will not biodegrade under the conditions of the test. Aerobic sewage 

18 treatment simulation tests are designed to yield information on the behavior of chemicals in 

19 aerobic sewage treatment plants. These tests permit the measurement of the rates of loss of the 

20 test chemical, formation and identification of degradation products, partitioning of these

21 chemicals to sludge solids, and volatilization under conditions controlled to mimic those found 

22 in full-scale aerobic wastewater treatment systems. The results from these studies are indicative 

23 of how the test substance will behave in full-scale systems.
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1 II. GENERAL OBLIGATIONS AND REQUIREMENTS

2 A. Total Cost. DuPont must spend no less than five million dollars ($5,000,000) 

3 in eligible SEP costs in performing activities under this Biodegradation SEP, but is not required 

4 to spend more than five million dollars ($5,000,000) in eligible SEP costs.

5 B. SEP Completion. DuPont shall comply with the deadlines set forth in this 

6 Appendix and will use its best efforts to satisfactorily complete this Biodegradation SEP, 

7 within the meaning of Section IV.4 of the CAFO, no later than March 27, 2014 (“SEP 

8 Completion Date”). No later than sixty (60) days prior to the SEP Completion Date, if DuPont 

9 believes that it will be unable to satisfactorily complete the SEP within such time period, 

10 DuPont shall petition EPA to extend the SEP Completion Date based upon DuPont’s assertion 

11 of good cause to extend such date. The Office of Civil Enforcement, in consultation with the 

12 Office of Pollution Prevention and Toxics, will review DuPont's petition and meet with 

13 DuPont to discuss its petition. The Office of Civil Enforcement, in consultation with the Office 

14 of Pollution Prevention and Toxics, shall determine whether DuPont has demonstrated that 

15 there is good cause to extend the SEP Completion Date and, if determining that DuPont has 

16 demonstrated good cause, determine how long to extend the SEP Completion Date.

17 C. Good Laboratory Practices and Study Monitor. For purposes of this 

18 Biodegradation SEP, with regard to characterization and biodegradation testing and studies, 

19 DuPont and its contractors shall be subject to, and must comply with, 40 C.F.R. Part 792. Each 

20 laboratory conducting research under this Biodegradation SEP shall designate a Study Director 

21 in accordance with 40 C.F.R. § 792.33. DuPont shall designate a Study Monitor that will serve 

22 as the point of contact for EPA and the laboratories.

23 D. Supply of Test Substances to Laboratories. DuPont shall provide the laboratory 
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1 that it contracts with to perform characterization and the laboratory that it contracts with to 

2 perform the biodegradation studies, sufficient quantities of the Fluorotelomer Products, 

3 identified in Attachment A, and any Corresponding Polymers, to perform all of the tests and 

4 studies discussed in this Biodegradation SEP for which such laboratory has been contracted to 

5 perform. Sufficient quantities of the Corresponding Polymers, identified in Attachment A for 

6 pilot testing, must include the quantities necessary to perform characterization, the pilot tests, 

7 and biodegradation studies, even if such Corresponding Polymers are not selected by EPA to 

8 be used in the biodegradation studies. Each Fluorotelomer Product and Purified Fluorotelomer 

9 Product that DuPont provides to the laboratory performing characterization must be from the 

10 same production batch as provided to the laboratory performing the biodegradation studies. 

11 Each Synthesized Fluorotelomer Product and Lab-scale Synthesized Fluorotelomer Product 

12 that DuPont provides to the laboratory performing characterization must be from the same 

13 laboratory batch as provided to the laboratory performing biodegradation testing.

14 E. Supply of Test Substances to EPA. EPA shall receive sufficient quantities of the 

15 Fluorotelomer Products identified in Attachment A, and Corresponding Polymers, to replicate 

16 the characterization and biodegradation studies (i.e., SCAS tests (including pilots)) performed 

17 under this Biodegradation SEP. DuPont shall fulfill this obligation as follows:

18 Sufficient quantities for EPA of the Fluorotelomer Products identified in 

19 Attachment A, the nine Synthesized Fluorotelomer Products, and the nine Lab-scale 

20 Synthesized Fluorotelomer Products shall be shipped by DuPont to a laboratory identified by 

21 EPA (per SEP A Section II.H.) on or before November 18, 2008 and

22 Sufficient quantities for EPA of the Purified Fluorotelomer Products 
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1 resulting from the PPA shall be shipped by DuPont no later than fourteen (14) days after 

2 sparging ceases for each such Product or by June 1, 2009, whichever occurs first. Further 

3 details on the quantities to be shipped, the specific timing for shipment, and shipment location 

4 are set forth in Section II.B.4. of the PPA. 

5 All test substances shall be provided to EPA following the chain of custody 

6 procedures in Attachment D, except that quart jars acceptable under DOT regulations may be 

7 substituted for the 30 mL containers. DuPont shall develop appropriate holding procedures for 

8 the test substances to assure the chemical integrity of such substances. These appropriate 

9 holding procedures shall be provided to EPA three (3) days in advance of the date that DuPont 

10 ships the test substance to the EPA-identified laboratory. 

11 F. Chain of Custody. Any instance in which, pursuant to this Biodegradation SEP, 

12 DuPont or a laboratory transfers either Fluorotelomer Products, Corresponding Polymers, or 

13 other chemicals to a laboratory or to EPA, DuPont and/or such laboratory(ies) are required to

14 follow the chain of custody procedures in Attachment D of this Appendix.

15 G. EPA Review and Approval (or Acceptance) Process. EPA will review and 

16 either approve or, pursuant to Section II.G.3, below, accept all work plans, protocols, contracts, 

17 request for proposals/bids, confidentiality agreements, lists, material modifications, and any 

18 other submission other than a final report, progress report, preliminary report, or quarterly 

19 report, relating to performance of this Biodegradation SEP.

20 1. In providing comments to DuPont regarding such documents or 

21 submissions, EPA will include justification(s) and/or rationale(s) for the comments. EPA will 

22 provide such comments to DuPont within a reasonable amount of time, commensurate with 

23 the type and nature of the document or submission being reviewed.
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1 2. All of EPA’s comments, including requested changes, to a document or 

2 submission enumerated above must be incorporated by DuPont, and/or its contractors, and 

3 resubmitted to EPA for approval. With regard to contracts, request for proposals/bids, and 

4 confidentiality agreements, if DuPont believes that EPA’s comments do not relate to the 

5 performance of the Biodegradation SEP, DuPont shall notify EPA within seven (7) business days 

6 of DuPont’s receipt of such comments. In this notification to EPA, DuPont shall explain why it 

7 believes that EPA’s comments do not relate to the performance of this Biodegradation SEP and 

8 that such comments are not required to be incorporated into the document. EPA shall consider 

9 DuPont’s explanation before making a final decision regarding whether such comments relate 

10 to the performance of this Biodegradation SEP; provided, however, that EPA will not 

11 unreasonably require DuPont to modify or remove from any such contract or agreement any 

12 provision that requires the contractor to indemnify DuPont for stipulated penalties that DuPont 

13 pays under Section VII.4 of the CAFO as a result of the contractor’s failure to perform work in 

14 accordance with a schedule to which the contractor has agreed.

15 3. In limited circumstances, EPA may, in its discretion, after reviewing a 

16 proposed contract, proposed confidentiality agreement, or proposed protocol opt to accept such 

17 a document without formally approving it. If EPA exercises this option, EPA will notify 

18 DuPont that the proposed contract or proposed confidentiality agreement has been accepted.

19 H. Submission Procedures and Transfer of Test Substances to EPA. All 

20 submissions by DuPont, a laboratory, or the Panel Administrator to EPA shall be submitted via 

21 first class mail, return receipt requested, or by commercial delivery service with documented 

22 delivery, to the person identified in Section V. of the CAFO. Such submissions shall be 

23 provided in electronic format on a compact disc (CD) and shall be accompanied by a cover 
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1 letter in hard copy that describes the contents of the CD and complies with any other 

2 requirements of the CAFO. In addition, as of January 1, 2012, the same submission shall also 

3 be submitted to EPA on a CD that is identified as containing documents for posting on the 

4 internet on www.regulations.gov in the folder labeled EPA-HQ-OPPT-2011-0991. The 

5 submissions for internet posting shall include an electronic version of the hard copy cover

6 letter that accompanied the submission to the person identified in Section V. of the CAFO. 

7 EPA will specify, in advance of the transfer of test substances addressed in Section II.E, above, 

8 where to transfer such divided samples.

9 I. Final Reports containing Confidential Business Information. All final reports 

10 provided to EPA containing Confidential Business Information (“CBI”) must also be provided to

11 EPA in a sanitized version within thirty (30) days of submission of the CBI version. Such final 

12 reports include final laboratory reports under 40 C.F.R. Part 792, final reports of the Peer 

13 Consultation Panel, and SEP Completion Reports submitted pursuant to Section IV of the 

14 CAFO and, as of January 1, 2012, sanitized Final Reports shall be submitted for posting by 

15 EPA on the internet on www.regulations.gov in the folder labeled EPA-HQ-OPPT-2011-0991. 

16 Any claim of CBI must be substantiated pursuant to 40 C.F.R. Part 2, upon submission of the 

17 sanitized version. Note that this Section II.I governs over CAFO Section V.9. with respect to 

18 the timing for submittal of sanitized final laboratory reports, final Peer Consultation Panel 

19 reports, and the SEP Completion Report. 

20 J. Manner in which Testing and Studies shall be Performed. The characterization 

21 and biodegradation studies must be performed in the following manner and in compliance with 

22 the following Attachments, unless DuPont or its contractor requests, and EPA approves, a 

23 change, or if EPA, after consultation with DuPont, determines that a change is appropriate:
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1 1. DuPont shall use one laboratory to characterize the Purified Fluorotelomer 

2 Products, one or more Corresponding Polymers identified in Attachment A for pilot testing, 

3 and any Corresponding Polymers that EPA selects for biodegradation studies, in accordance 

4 with Attachment B.

5 2. DuPont shall use one laboratory to perform SCAS studies (alternatively 

6 referred to herein as the “biodegradation studies”), in accordance with Attachment C.

7 a. This laboratory shall perform the SCAS studies on the 

8 Fluorotelomer Products and any Corresponding Polymers that EPA selects for biodegradation 

9 studies, following both the sequence, and grouping (to maximize laboratory efficiency, 

10 capacity allowing) provided in Attachment A.

11 b. If, based on their submissions in response to the Request for 

12 Proposals (“RFP”) and any further information that DuPont or EPA receives, none of the 

13 laboratories identified in Attachment G appears to be reasonably capable of, or if no laboratory 

14 is willing to contractually commit to, completing all of the biodegradation studies (including 

15 pilots) by no later than September 1, 2011 (or such longer time as EPA approves), the parties 

16 agree to implement the following approach, in the following order of preference:

17 i. DuPont shall use one laboratory identified in Attachment 

18 G to perform the biodegradation studies but not the analytical component of the studies, and 

19 DuPont shall use the laboratory that DuPont contracts with to perform characterization of the 

20 Fluorotelomer Products and any Corresponding Polymers under this Biodegradation SEP, as a 

21 subcontractor for the analytical component of the biodegradation studies; or

22 ii. DuPont shall propose two laboratories identified in 

23 Attachment G to perform the biodegradation studies and shall propose how to divide the 
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1 biodegradation work between the two laboratories, subject to EPA approval.

2 3. Pilot Testing

3 a. The laboratory performing the biodegradation studies shall conduct 

4 one pilot test for SCAS on each of the Fluorotelomer Products that have been selected for pilot 

5 testing as identified in Attachment A, and shall conduct a pilot test for SCAS on each of the 

6 Corresponding Polymers that have been selected for pilot testing as identified in Attachment A, 

7 to develop test data that can inform protocol decisions and to establish that these 

8 biodegradation studies can produce results that can be analyzed and quantified with regard to 

9 the biodegradation potential of the Fluorotelomer Products and any Corresponding Polymers. 

10 The first pilot test shall be for fourteen (14) days. Any subsequent pilot tests shall be 

11 conducted for up to fourteen (14) days, with the exact number of days to be determined by 

12 EPA prior to the start of each pilot test. 

13 b. EPA reserves the right, after reviewing the results of the first pilot 

14 of the Fluorotelomer Products or first pilots of its Corresponding Polymers, to specify the use of 

15 the Corresponding Polymers for the pilot tests in the remaining groups.

16 c. The Peer Consultation Panel, described in Section V, below, shall 

17 review the results of such pilots, including the pilots’ protocol and design, in conjunction with 

18 the characterization data. The Panel Administrator shall develop and forward to EPA and 

19 DuPont a final Panel report providing: (1) each participating Panel member’s comments and 

20 recommendations on appropriate final protocols for the laboratory to use for the biodegradation 

21 studies and (2) comments and recommendations regarding which of the Corresponding Polymers

22 should be used in the biodegradation studies. EPA will review the Panel report and any 

23 comments that DuPont has submitted to EPA pursuant to Section II.K, below. EPA will then 
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1 transmit its comments and judgments to DuPont and require DuPont to direct the laboratory to 

2 develop a final protocol, within a specified timeframe, to be submitted to EPA for approval. 

3 The final protocol that the laboratory develops shall consider the Panel report and EPA’s 

4 comments and judgments. The laboratory shall not commence the biodegradation studies until 

5 it has received EPA’s approval of the final protocol and EPA’s determination regarding which 

6 of the Corresponding Polymers shall be used in the biodegradation studies.

7 K. DuPont Comments. At any time during the performance of this Biodegradation 

8 SEP, DuPont may provide comments to EPA regarding the following technical documents: 

9 protocols, test methods, analytical methods (and any modifications of such technical 

10 documents), and the Panel report addressing the charge set forth in Section V.A.2.b. To be 

11 eligible for consideration by EPA, DuPont must submit such comments to EPA within seven 

12 (7) business days of DuPont’s receipt of the technical document. EPA reserves the right to 

13 directly seek input from the appropriate laboratory regarding DuPont’s comments. The 

14 extension of deadlines in Section II.L, below, does not apply to this Section II.K. A request for 

15 an extension of this deadline shall be subject to EPA’s discretion, and granted for good cause 

16 shown.

17 L. Extensions of deadlines other than the SEP Completion Date.

18 1. First Extensions. For an extension of a deadline specified in this 

19 Appendix or in a work plan or other submission implementing this Biodegradation SEP, other 

20 than the SEP Completion Date, DuPont shall be entitled to a first extension as a matter of right, 

21 provided that DuPont submits a written notice to EPA that it is exercising this provision, no 

22 later than one business day prior to the deadline.

23 a. For deadlines of thirty (30) days or less, DuPont shall 
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1 automatically receive an extension equal to the number of days initially provided in this 

2 Appendix.

3 b. For deadlines greater than thirty (30) days, DuPont shall 

4 automatically receive a 30-day extension unless DuPont requests, and EPA approves, an 

5 extension greater than thirty (30) days, for good cause shown.

6 c. For deadlines that are not stated in terms of number of days after a 

7 preceding event but are stated as specific dates, DuPont shall automatically receive a 30-day 

8 extension unless DuPont requests, and EPA approves, an extension greater than thirty (30) days,

9 for good cause shown.

10 2. Second Extension (for Third Party Work only). For an extension of a 

11 deadline other than the SEP Completion Date involving work that DuPont has contracted with 

12 a third party to perform, if, after exercising its right to an automatic extension provided in 

13 Section II.L.1, above, DuPont requests a second extension of the same deadline, such extension 

14 shall be granted provided that DuPont’s Study Monitor sent a written notice to the third party 

15 no later than five (5) business days before the deadline, and DuPont requests an extension no 

16 later than one (1) business day prior to the deadline. In exercising this provision, DuPont shall 

17 furnish EPA with the written notice that it sent to the third party.

18 a. For deadlines of thirty (30) days or less, DuPont shall receive an 

19 extension equal to the number of days initially provided in this Appendix.

20 b. For deadlines greater than thirty (30) days, DuPont shall receive a 

21 30-day extension unless DuPont requests, and EPA approves, an extension greater than thirty 

22 (30) days, for good cause shown.

23 3. Additional Extensions. DuPont’s request for an extension other than the 
Exhibit 1

Revised 12/22/11

19

1 SEP Completion Date for which there is either: (a) a second request for an extension of a 

2 deadline that does not involve work that DuPont has contracted with a third party to perform, 

3 or (b) a third request for an extension of a deadline that does involve work that DuPont has 

4 contracted with a third party to perform, or (c) subsequent requests for extensions of deadlines 

5 addressed in Sections II.L.3.a-b, such requests are subject to EPA’s discretion, and granted for 

6 good cause shown. In granting a request for an extension under Section II.L.3, EPA may grant 

7 an extension of time different from the amount of time requested by DuPont.

8 4. Delays resulting from EPA Review. If DuPont is delayed in performing 

9 a required action prescribed in an EPA-approved work plan and the delay is caused only 

10 because of EPA’s review and approval of a submission that DuPont provided to EPA 

11 sufficiently in advance of the deadline so as to allow EPA a reasonable amount of time to 

12 review and approve the submission, commensurate with the type and nature of the submission, 

13 DuPont will be entitled to an extension to perform the required action. The extension shall be 

14 equal to the number of days of EPA’s review and approval of the submission and shall be 

15 calculated from the date that EPA received such submission through the date that EPA 

16 transmitted its approval of the submission to DuPont. If, during its review and prior to its 

17 approval, EPA requests that DuPont make changes to the submission, in calculating the 

18 extension, the parties shall not include the amount of time for DuPont to make such changes 

19 and resubmit the document to EPA for approval. Such time excluded from the extension shall 

20 start from the date that EPA transmits the requested changes to DuPont through the date that 

21 EPA receives the amended submission, incorporating the requested changes. But, such time 

22 excluded from the extension shall not include time during which EPA is still reviewing a 

23 portion of the submission for which EPA has also requested changes. If an extension is granted 
Exhibit 1

Revised 12/22/11

20

1 under this provision, DuPont may still request an extension of the extended deadline under 

2 Sections II.L.1-3, above.

3 5. To the extent that this Section II.L governs requests for extensions of 

4 deadlines under this Biodegradation SEP, it shall supersede any provisions in the CAFO 

5 concerning the extension of deadlines.

6 M. Trial Run to Assess Fluorotelomer Based Polymer Residuals Baseline 

7 Agreement. Prior to the commencement of any full scale determinative SCAS testing, 

8 DuPont shall assess whether the residual levels in a SCAS trial run time zero sample of the 

9 polymer test substance reported by the Biodegradation Laboratory substantially agree with the 

10 residual levels of the polymer test substance as reported in the Certificate of Analysis from the 

11 Characterization Laboratory. For this section, the following two variants of the test substances 

12 shall be used: (1) the Purified Fluorotelomer Product and (2) the Lab-scale Synthesized 

13 Fluorotelomer Product. The chemical characterization conducted by the Characterization 

14 Laboratory is designed to identify and quantify the residuals (also referred to as analytes) listed 

15 in Attachment C. Knowing that residual levels can be accurately quantified before full scale 

16 SCAS testing begins assures a basis upon which the residuals at the conclusion of SCAS 

17 testing can be identified and quantified with accuracy. Although some variation may be 

18 anticipated and some residuals may have less impact on the study results, to assure that the 

19 SEP provides quality data, DuPont will proceed with full scale definitive SCAS testing on a 

20 given test substance only if the “substantially equivalent residual levels” requirements of either 

21 section M.1.i or M.1.ii are satisfied. 

22 1. “Substantially equivalent residual levels” will be satisfied for the purposes 

23 of this SEP by meeting either the requirements of section M.1.i. to achieve a 95% molar 
Exhibit 1

Revised 12/22/11

21

1 equivalence or by EPA’s approval as described in M.1.ii.

2 i. “Substantial equivalence by meeting a 95% molar equivalence” is 

3 achieved where the sums of the molar concentrations of each analyte reported by the 

4 Characterization Laboratory for the polymer test samples compared to the sums of the molar 

5 concentrations of each analyte reported by the Biodegradation Laboratory for the trial run time 

6 zero sample agree with a 95% molar equivalence. The Characterization Laboratory shall 

7 measure analytes of interest from six (6) replicate samples of the polymer test substances (i.e., 

8 the variants identified above). The Biodegradation Laboratory shall measure analytes from 

9 two (2) replicate trial run time zero samples from each of three (3) separate test substance 

10 dosed SCAS units for a total of six (6) replicate samples for one or both variants. The 

11 Biodegradation Laboratory shall also measure "Background" by measuring analytes from two 

12 (2) replicate trial run time zero samples from each of three (3) separate SCAS units to which 

13 test substance has not been dosed for a total of six (6) replicate samples. Trial run time zero 

14 samples will be collected from all six (6) SCAS units subsequent to the draw and fill procedure 

15 after a minimum of two (2) minutes after aeration has started to allow for uniform distribution 

16 of test substance in the SCAS units.

17 ii. If agreement with the 95% molar equivalence of section M.1.i. is 

18 not achieved, then EPA shall review the data associated with the residual levels to determine 

19 whether there is sufficient confidence to begin the full scale SCAS testing.

20 2. If it is necessary for EPA to review the residual levels from the time zero 

21 trial run with the residual levels reported by the Characterization Laboratory, and if EPA 

22 determines that the differences between the residual levels determined for the time zero trial 

23 run and the residual levels reported by the Characterization Laboratory are too great to allow 
Exhibit 1

Revised 12/22/11

22

1 conclusions to be drawn on whether biodegradation of the test substance(s) in the definitive 

2 SCAS test occurs, then full scale SCAS testing shall not be initiated and DuPont shall perform 

3 the activities listed in Section VI below.

4 III. SELECTION OF THIRD PARTY LABORATORIES

5 A. Development of Confidentiality Agreement. Within forty-five (45) days from the 

6 date DuPont signs the Consent Agreement, DuPont shall submit to EPA the confidentiality 

7 agreement that DuPont intends to use with any laboratory. Within seven (7) business days of 

8 receipt of EPA’s approval (or acceptance) of the confidentiality agreement, DuPont must provide 

9 the laboratories listed in Attachment G with a confidentiality agreement and request that such 

10 confidentiality agreement be signed and returned by a date certain consistent with the deadlines 

11 established in this Appendix.

12 B. Development of Request for Proposals. By February 1, 2006, DuPont shall 

13 submit to EPA one or more draft Requests for Proposals (RFPs) to be sent to all of the 

14 laboratories identified in Attachment G to solicit proposals for (1) characterizing the 

15 Fluorotelomer Products and any Corresponding Polymers, and (2) conducting the SCAS 

16 studies on the Fluorotelomer Products and any Corresponding Polymers (including pilot 

17 testing).

18 The proposed RFPs must at least include the following elements:

19 1. The laboratory’s obligation, if selected, to follow 40 C.F.R. Part 792, and 

20 prepare (or subcontract for preparation of) and comply with, a QAPP, provided in Attachment E

21 of this Appendix.

22 2. All existing information that would be reasonably relevant to assisting 

23 the laboratory to develop a firm cost estimate, with pricing, for the work that the laboratory is 
Exhibit 1

Revised 12/22/11

23

1 solicited to perform, which must include such information as the identity, structure, and 

2 compositional analysis of the Fluorotelomer Products. The laboratory’s proposal may be 

3 based upon not-to-exceed estimates for the proposed work or any other method that provides, 

4 to the extent feasible, a firm cost estimate for the work.

5 a. Laboratories receiving the RFP for characterization of the 

6 Fluorotelomer Products and Corresponding Polymers must provide cost estimates for 

7 characterizing all of the Fluorotelomer Products and their Corresponding Polymers.

8 b. Laboratories receiving the RFP for the biodegradation work must 

9 include cost estimates for conducting 14-day pilot tests for SCAS on the Fluorotelomer 

10 Products and the Corresponding Polymers, as identified in Attachment A, and for performing 

11 SCAS studies on all Fluorotelomer Products and their Corresponding Polymers.

12 3. The laboratory’s cost proposal should include the identification of any 

13 analytical methods that the laboratory anticipates needing to develop in order to perform any of 

14 the required analytical work associated with the characterization or biodegradation studies 

15 required under this Biodegradation SEP.

16 4. For the laboratories receiving the RFP for the biodegradation work, 

17 DuPont shall provide the guidelines for SCAS, included in Attachment C of this Appendix.

18 5. A requirement that the recipient identify in its proposal a general schedule 

19 and budget for completion of the proposed work identified in the RFP in accordance with the 

20 deadlines and criteria set forth in this Appendix.

21 6. A copy of Section II.L, above, and the terms and conditions 

22 identified in Section III.F.2, below.

23 7. Notice that failure to submit a proposal meeting all of the criteria in the 
Exhibit 1

Revised 12/22/11

24

1 RFP to DuPont within thirty (30) days of the laboratory’s receipt of the RFP may render the 

2 laboratory ineligible for selection.

3 C. Within seven (7) days of receipt of the approved RFP, DuPont shall provide the 

4 EPA-approved RFPs to all laboratories listed in Attachment G that have submitted to DuPont a 

5 signed confidentiality agreement. If DuPont has not received a signed confidentiality 

6 agreement from a laboratory by the date that DuPont is required to provide the RFP, DuPont 

7 shall notify EPA why it cannot send the RFP to such laboratory. EPA reserves the right to 

8 contact such laboratory to inquire why it has not returned the confidentiality agreement and, if 

9 such laboratory agrees within seven (7) business days of contact by EPA to sign and submit the 

10 confidentiality agreement to DuPont, DuPont shall then provide the RFP to the laboratory.

11 D. Laboratory Eligibility. Within forty-five (45) days of EPA’s approval of the 

12 RFPs, or such longer time as EPA has approved in accordance with Section III.D.2, below, 

13 DuPont must receive a firm proposal back from a laboratory receiving an RFP in order for that 

14 laboratory to be eligible to perform work under this Biodegradation SEP.

15 1. DuPont shall require the recipients to submit one duplicate copy of its 

16 proposal to EPA concurrent with its submission to DuPont.

17 2. If a laboratory that received the RFP does not submit a proposal to DuPont 

18 within thirty (30) days of receipt of the RFP, EPA reserves the right to contact such laboratory

19 to inquire why it has not submitted a proposal to DuPont. If the laboratory indicates that it 

20 wants to submit a proposal, the laboratory must do so by a date to be specified by EPA, which 

21 shall not be longer than fourteen (14) days after contact by EPA, unless the parties agree to a 

22 longer time period.

23 E. Selection of Laboratories. No later than fourteen (14) days after receipt of the 
Exhibit 1

Revised 12/22/11

25

1 last bid that DuPont received within the applicable period for submission under III.D, DuPont 

2 must propose to EPA the laboratory that DuPont would like to use to perform the 

3 characterization of the Fluorotelomer Products and Corresponding Polymers, and the laboratory 

4 that DuPont would like to use to perform the biodegradation studies of the Fluorotelomer 

5 Products and Corresponding Polymers.

6 1. DuPont must provide EPA with a detailed rationale describing why 

7 DuPont has selected such laboratories to perform the work and why it has not selected the 

8 other laboratories that submitted a proposal to perform such work.

9 2. DuPont shall contract with only one laboratory to perform the modified 

10 SCAS studies on the Fluorotelomer Products and Corresponding Polymers. DuPont shall 

11 contract with only one laboratory to characterize the Fluorotelomer Products and 

12 Corresponding Polymers.

13 3. If, after proposal submission, EPA rejects either the laboratory for 

14 characterization and/or the laboratory for biodegradation testing, EPA will provide DuPont with 

15 a written rationale for the rejection and require DuPont to propose a different laboratory from 

16 which DuPont has received a proposal. The parties will continue this process until EPA agrees 

17 to DuPont’s laboratory selection.

18 4. If no laboratories submit proposals to DuPont, or if none of the proposals 

19 submitted is acceptable to EPA, the Directors of the Office of Civil Enforcement and the 

20 Office of Pollution Prevention and Toxics shall meet with DuPont to discuss appropriate 

21 changes that can be made to this Biodegradation SEP to foster laboratory participation in the 

22 performance of this Biodegradation SEP. EPA and DuPont shall first implement the alternative 

23 approach set forth in Section II.J.2.b before EPA considers whether to expand the list of 
Exhibit 1

Revised 12/22/11

26

1 potential laboratories identified in Attachment G to include foreign laboratories. If the parties 

2 cannot agree to any such appropriate changes, or if after agreeing to such appropriate changes, 

3 no laboratories submit a proposal, this Biodegradation SEP shall be deemed to have ceased 

4 prior to its completion, in which case, DuPont shall not be subject to Section VII.3 of the 

5 CAFO but DuPont shall be subject to Section VII.1 of the CAFO, and the parties may exercise 

6 Section VI of the CAFO even though this Biodegradation SEP is not deemed satisfactorily 

7 completed.

8 F. Laboratory Contract Requirements. Within thirty (30) days of EPA’s approval 

9 of the laboratories under Section III.E, DuPont must provide EPA with a final draft of the 

10 proposed contract that DuPont and the two laboratories have negotiated.

11 1. No contract shall be executed by DuPont and a laboratory until EPA has 

12 reviewed and either approved or accepted the contract in accordance with Section II.G.2.

13 2. The proposed contract must include the following terms and conditions in 

14 addition to the elements discussed in Section III.B, above:

15 a. The laboratory consents to inspection, for purposes of this 

16 Biodegradation SEP, at any reasonable time, as provided in 40 C.F.R. § 792.15.

17 b. All laboratory personnel must directly answer any questions from 

18 EPA pertaining to work the laboratory is performing under this Biodegradation SEP. Any 

19 request from EPA for written information from a laboratory pertaining to work it is 

20 performing under this Biodegradation SEP will be transmitted through DuPont’s designated 

21 Study Monitor. DuPont’s Study Monitor shall notify the laboratory of EPA’s request for such 

22 information within three (3) business days of EPA’s request, and the laboratory shall provide 

23 such information to EPA and DuPont within three (3) business days of DuPont’s Study 
Exhibit 1

Revised 12/22/11

27

1 Monitor’s notice to the laboratory.

2 i. If, based upon oral or written information so obtained, 

3 EPA believes that a minor modification(s) to an approved or accepted test protocol or other 

4 analytical method must be made, EPA will inform DuPont of the modification and require 

5 DuPont to instruct the laboratory to implement the change immediately and continue running 

6 the test. DuPont may submit comments for EPA’s consideration regarding such modification, 

7 in accordance with Section II.K, above.

8 ii. If, based upon oral or written information so obtained, 

9 EPA believes that a modification to an approved or accepted test protocol or other analytical 

10 method must be made that requires the laboratory to stop the test and start again, EPA will 

11 inform DuPont of the modification and require DuPont to instruct the laboratory to provide 

12 EPA and DuPont with all data generated up to that date and immediately terminate the test and 

13 re-run the test implementing the modification. DuPont may submit comments for EPA’s 

14 consideration regarding such modification, in accordance with Section II.K, above.

15 c. EPA shall have the exclusive authority to approve all work plans, 

16 protocols, and test methods that the study sponsor would otherwise approve under 40 C.F.R. Part

17 792 as well as any analytical methods not expressly enumerated in 40 C.F.R. Part 792, and the 

18 QAPPs. DuPont may submit comments for EPA’s consideration regarding such technical 

19 documents, in accordance with Section II.K, above.

20 d. Material Modifications. Any proposed material modification that 

21 a laboratory or DuPont would like to make that involves work conducted under this 

22 Biodegradation SEP must be approved by EPA prior to implementation. For purposes of this 

23 Biodegradation SEP, a material modification is an adjustment to the work conducted under this 
Exhibit 1

Revised 12/22/11

28

1 Biodegradation SEP made in the normal course of implementing such work that would result in a

2 substantive alteration of the biodegradation studies or other activities conducted under this 

3 Biodegradation SEP.

4 e. EPA and DuPont shall receive written notification from the 

5 laboratory no later than five (5) business days before the laboratory makes any modification 

6 that involves work previously approved by EPA under this Biodegradation SEP, except as 

7 provided in Section III.F.2.f, below. If, based upon this notification, EPA believes that such 

8 modification is material, EPA will orally notify DuPont and the laboratory immediately, and 

9 require DuPont to instruct the laboratory to submit such proposed modification to EPA for

10 approval within the timeframe that EPA establishes in the oral notice. DuPont may submit 

11 comments for EPA’s consideration regarding such modification, in accordance with Section II.

12 K, above.

13 f. Emergency Modifications. In the event of an emergency, the 

14 laboratory may make a modification that involves work previously approved by EPA under 

15 this Biodegradation SEP, to address an unforeseen circumstance or occurrence that will have 

16 an adverse affect on the test if not immediately implemented. The laboratory shall provide 

17 notice to EPA and DuPont within twenty-four (24) hours of such modification. If, based upon 

18 this modification, EPA believes that the laboratory must stop the test and start again or that the 

19 laboratory should implement an additional change, EPA will require DuPont to instruct the 

20 laboratory to provide EPA and DuPont with all data generated up to that date and either 

21 immediately terminate the test and re-run the test or immediately implement the additional 

22 change. DuPont may submit comments for EPA’s consideration regarding such modification or 

23 additional change, in accordance with Section II.K, above.
Exhibit 1

Revised 12/22/11

29

1 g. Progress Reports. Within thirty (30) days of commencing the 

2 technical work, and by the first day of each month thereafter until the laboratory submits its 

3 last final report under Section IV.C, below, the laboratory shall provide EPA and DuPont with 

4 a progress report that describes the technical work performed, a copy of the raw data generated 

5 up to that date, and costs incurred.

6 h. Information Exchange. When the laboratory provides any 

7 information in written form to EPA or DuPont concerning the laboratory’s work under this 

8 Biodegradation SEP, the laboratory shall provide such information to the other party as soon as 

9 practicable. The laboratory is not responsible for disseminating information that it receives in 

10 written form from DuPont; DuPont shall concurrently provide the information to EPA. When 

11 the laboratory provides information in oral form to EPA or DuPont concerning the laboratory’s 

12 work under this Biodegradation SEP, the laboratory shall communicate such information to the 

13 other party as soon as practicable. The laboratory is not responsible for communicating 

14 information it receives in oral form from DuPont or EPA; each party shall communicate such 

15 information to the other party. However, when the laboratory receives an oral communication 

16 from DuPont or EPA, it shall notify both parties and provide a brief written description of such 

17 oral communication. To the extent practicable, the parties shall jointly communicate orally 

18 with the laboratory in light of the laboratory’s obligation to prepare a written notification to the 

19 parties when it receives an oral communication, not jointly, from either party.

20 i. The laboratory shall allow Peer Consultation Panel members to 

21 visit the laboratory, as necessary, when the Peer Consultation Panel has a meeting(s) and/or 

22 deliberations relevant to the work that the laboratory is performing under this Biodegradation 

23 SEP.
Exhibit 1

Revised 12/22/11

30

1 G. Contract Execution. Within five (5) business days of receipt of EPA’s 

2 approval (or acceptance) of the proposed contract in accordance with Section II.G.2, DuPont 

3 must sign and forward the contract to the laboratory for execution.

4 a. DuPont and the laboratory shall seek to execute the contract within thirty 

5 (30) days of receipt of EPA’s approval (or acceptance) of the proposed contract. If DuPont 

6 and the laboratory have not executed the contract within thirty (30) days, DuPont must, inform 

7 EPA of the delay, explain the reason for the delay, provide a reasonable estimate as to when the 

8 contract will be executed, and exercise its right to an automatic extension in Section II.L, 

9 above. After exercising its right to an automatic extension in Section II.L, but before a second 

10 request for an extension under Section II.L, if DuPont believes that, notwithstanding its best 

11 efforts, the laboratory will not enter into the contract with DuPont, DuPont shall provide 

12 notice to EPA of the impasse. EPA reserves the right to contact such laboratory, upon receipt 

13 of such notice from DuPont, to inquire why the laboratory has not entered into the contract 

14 with DuPont. If DuPont and the laboratory have not entered into a contract within fourteen 

15 (14) days EPA’s inquiry, unless DuPont and EPA agree to a longer time period, then the parties 

16 shall follow the approach set forth in Section III.H, below.

17 b. Within five (5) business days from the date that DuPont and the 

18 laboratory execute the contract, DuPont must notify EPA that it has entered into the 

19 contract with the laboratory.

20 H. If no laboratory enters into a contract with DuPont, the Directors of the Office of 

21 Civil Enforcement and the Office of Pollution Prevention and Toxics shall meet with DuPont 

22 to discuss appropriate changes that can be made to this Biodegradation SEP to foster laboratory 

23 participation in the performance of this Biodegradation SEP. If the parties cannot agree to any 
Exhibit 1

Revised 12/22/11

31

1 such appropriate changes, or if after agreeing to such appropriate changes, no laboratories enter 

2 into a contract with DuPont, this Biodegradation SEP shall be deemed to have ceased prior to 

3 its completion, in which case, DuPont shall not be subject to Section VII.3 of the CAFO but 

4 DuPont shall be subject to Section VII.1 of the CAFO, and the parties may exercise Section VI 

5 of the CAFO even though this Biodegradation SEP is not deemed satisfactorily completed.

6 I. Commencement of Work. Within thirty (30) days from the date that DuPont and 

7 each laboratory execute the contract, the laboratory must commence the work it has agreed to 

8 perform under the contract, as described in Section IV, below.

9 IV. TESTS TO BE PERFORMED ON DUPONT FLUOROTELOMER PRODUCTS 

10 AND CORRESPONDING POLYMERS

11 A. Characterization of the Fluorotelomer Products and Corresponding Polymers

12 1. As provided in Section III.I, the laboratory shall commence the work 

13 identified in this Section IV.A, within thirty (30) days from the date that DuPont and the 

14 laboratory execute the contract to perform work under this Biodegradation SEP. The 

15 laboratory shall commence such work by submitting a work plan to EPA that describes the 

16 work the laboratory has been contracted to perform, addressing all requirements for such work 

17 under this Biodegradation SEP (including Attachment B), and a general schedule and budget 

18 for completion of the work. Within forty-five (45) days from the date that DuPont and the 

19 laboratory execute the contract to perform work under this Biodegradation SEP, the laboratory 

20 shall submit to EPA all relevant technical documents that require EPA’s approval.

21 2. Within fourteen (14) business days of EPA’s approval of the work plan 

22 and all relevant technical documents, the laboratory shall begin the implementation of the 

23 EPA-approved work plan.
Exhibit 1

Revised 12/22/11

32

1 3. Within fourteen (14) business days of characterizing each Fluorotelomer 

2 Product and any Corresponding Polymers, the laboratory shall provide EPA and the Panel 

3 Administrator, a Certificate of Analysis, as provided in Attachment F, as well as the 

4 protocols and a copy of the raw data. The laboratory shall provide the QAPP to the Panel 

5 Administrator with the first Certificate of Analysis but need not provide the QAPP for the 

6 remaining eight Fluorotelomer Products and Corresponding Polymers.

7 B. Biodegradation Studies: SCAS

8 1. As provided in Section III.I, the laboratory shall commence the work 

9 identified in this Section IV.B, within thirty (30) days from the date that DuPont and the 

10 laboratory execute the contract to perform such work. The laboratory shall commence such 

11 work by submitting a work plan to EPA that describes the work the laboratory has been 

12 contracted to perform, addressing all requirements for such work under this Biodegradation 

13 SEP (including Attachment C), and a general schedule and budget for completion of the work. 

14 Within ninety (90) days from the date that DuPont and the laboratory execute the contract to 

15 perform work under this Biodegradation SEP, the laboratory shall submit to EPA all relevant 

16 technical documents that require EPA’s approval.

17 2. Within fourteen (14) business days of EPA’s approval of the work plan 

18 and all relevant technical documents, the laboratory shall begin the implementation of the 

19 EPA-approved work plan.

20 a. The laboratory shall run the SCAS test for twelve (12) weeks. The 

21 inoculum source shall be activated sludge mixed liquor from a municipal wastewater treatment 

22 plant operating in compliance with its National Pollutant Elimination Discharge System 

23 (“NPDES”) permit. Settled domestic sewage from a municipal wastewater treatment plant 
Exhibit 1

Revised 12/22/11

33

1 operating in compliance with its NPDES permit shall be used as feed. Daily samples of the 

2 aqueous phase, sludge solids, and off gas shall be collected, analyzed, and quantified for the 

3 analytes listed in Attachment C of this Biodegradation SEP. If at any time EPA determines, or 

4 if DuPont or the laboratory recommends and EPA determines, that daily sampling is not 

5 necessary, EPA will notify DuPont to instruct the laboratory of a change in the sampling 

6 schedule and establish a new timeframe for sampling. Analyses shall be conducted using the 

7 most accurate instrumentation and procedures available as of the time of testing. All analytical 

8 methods shall be approved by EPA prior to the start of the studies.

9 3. The laboratory shall conduct one 14-day pilot test for SCAS on the first 

10 Purified Fluorotelomer Product that has been selected for pilot testing as identified in 

11 Attachment A, and shall conduct one pilot test lasting up to 14 days, with the exact time to be 

12 determined, for SCAS on other Corresponding Polymers that have been selected for pilot 

13 testing as identified in Attachment A, to develop test data that can inform protocol decisions 

14 and to establish that these biodegradation studies can produce results that can be analyzed and 

15 quantified with regard to the biodegradation potential of the Fluorotelomer Products and 

16 Corresponding Polymers.

17 4. Pilot Preliminary Reports. No later than fourteen (14) days after the 

18 laboratory completes each pilot test, the laboratory shall provide EPA, DuPont, and the Panel 

19 Administrator with a preliminary report regarding the pilot test results. In providing the 

20 preliminary report, the laboratory shall summarize the pilot test results and provide the QAPP,

21 the protocols, and a copy of the raw data.

22 5. Within fourteen (14) business days after EPA has approved the final 

23 design and protocols for the SCAS studies, the laboratory shall begin the biodegradation studies 
Exhibit 1

Revised 12/22/11

34

1 following the sequence and groupings (capacity allowing) provided in Attachment A.

2 a. EPA reserves the right to omit any analyte identified in 

3 Attachment C for purposes of the biodegradation studies.

4 b. Upon consideration of the Panel’s report addressing the charge in 

5 Section V.A.2.c, additional characterization data for any purified or synthesized Corresponding

6 Polymers that had not been characterized prior to the Panel’s report, and the amount of 

7 remaining eligible SEP dollars, EPA shall determine which of the Corresponding Polymers, if 

8 any, shall be used in the biodegradation studies.

9 6. Study Preliminary Reports. Within seven (7) business days of the 

10 laboratory completing the biodegradation studies on the first Fluorotelomer Product and any of 

11 its Corresponding Polymers (or first group of Fluorotelomer Products and any of their 

12 Corresponding Polymers), the laboratory shall submit a preliminary report summarizing the 

13 study results to EPA, DuPont, and the Panel Administrator for distribution to the Peer 

14 Consultation Panel.

15 a. In providing the preliminary report, the laboratory shall also 

16 provide the protocols and a copy of the raw data. The laboratory shall only provide the QAPP

17 to the Panel Administrator with the first Fluorotelomer Product and any of its Corresponding 

18 Polymers (or first group of Fluorotelomer Products and any of their Corresponding Polymers).

19 b. As the laboratory completes biodegradation studies on each 

20 Fluorotelomer Product and Corresponding Polymers (or group of Fluorotelomer Products and

21 Corresponding Polymers), the laboratory shall submit preliminary reports and associated 

22 information described in Section IV.B.6.a, above, to EPA, DuPont, and to the Panel 

23 Administrator for distribution to the Peer Consultation Panel.
Exhibit 1

Revised 12/22/11

35

1 C. Reporting Test and Study Results

2 1. Each laboratory shall follow 40 C.F.R. Part 792, subpart J in preparing the 

3 final report for the tests that it performs.

4 2. Each laboratory must submit a final report to EPA, DuPont, and the Panel 

5 Administrator within thirty (30) days of completing all of the work identified in its contract 

6 with DuPont.

7 V. PEER CONSULTATION FOR TESTS PERFORMED ON DUPONT 

8 FLUOROTELOMER PRODUCTS AND CORRESPONDING POLYMERS

9 A. Peer Consultation Panel and Charges. As part of this Biodegradation SEP, 

10 DuPont shall contract with an independent third party to serve as a Panel Administrator to 

11 implement and administer the Peer Consultation process under this Biodegradation SEP.

12 1. The Panel Administrator shall select a Peer Consultation Panel (“Panel”) 

13 that will address the charges set forth in Section V.A.2, below.

14 a. The Panel Administrator shall solicit potential Panel member 

15 nominations from the public, will allow self-nomination, and may nominate potential Panel 

16 members. The parties may submit Panel member nominations to the Panel Administrator.

17 b. After receiving Panel member nominations, the Panel 

18 Administrator shall develop a pool of potential Panel members that will be subject to comment 

19 by EPA, DuPont, and the public.

20 c. After considering all comments received regarding the Panel 

21 member pool, the Panel Administrator shall select a potential Panel and submit the potential 

22 Panel to EPA and DuPont for comment. The Panel Administrator has the exclusive authority to 

23 select the Panel. If both parties, independently, recommend to the Panel Administrator that a 
Exhibit 1

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36

1 particular potential Panel member would not be appropriate to serve on the Panel, the Panel 

2 Administrator shall remove such individual from the potential Panel and from the pool, select a 

3 new potential Panel from the pool of potential Panel members, and then submit a new potential 

4 Panel to EPA and DuPont for comment. The Panel Administrator shall follow this approach 

5 until it has selected a final Panel.

6 d. The Panel Administrator shall treat all comments received under 

7 Sections V.A.1.b and V.A.1.c as confidential.

8 2. The Panel is charged to:

9 a. Review the approved or accepted protocols that the laboratory used 

10 to characterize the Fluorotelomer Products and Corresponding Polymers for chemical 

11 characteristics, compositional analysis, oligomeric content, molecular weight distribution, and 

12 residual content as discussed in Attachment B of this Biodegradation SEP and determine:

13 i. whether the approved or accepted protocols were 

14 sufficiently robust to provide reliable characterization data, and

15 ii. whether the laboratory correctly followed the protocols.

16 b. Review the design and approved or accepted protocol that was 

17 used to run each pilot and results for each pilot to provide comments and recommendations for 

18 developing a final design and protocol for SCAS studies that will be approved by EPA prior to 

19 implementation by the laboratory.

20 c. Compare the pilot results and characterization data of each 

21 Fluorotelomer Product to the pilot results and characterization data of its Corresponding Polymer

22 to advise EPA regarding the similarities and differences of the Corresponding Polymers as 

23 compared to the Fluorotelomer Products, and which, if any, of the Corresponding Polymers
Exhibit 1

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37

1 should be used in the biodegradation studies.

2 i. If, based upon such comparison, the Panel can identify one 

3 Corresponding Polymer for each Fluorotelomer Product that should be used in the 

4 biodegradation studies, the Panel shall so state, and provide a detailed explanation as to why it is

5 appropriate to use only this one Corresponding Polymer in the biodegradation studies.

6 ii. If, based upon such comparison, the Panel cannot identify 

7 one Corresponding Polymer for each Fluorotelomer Product but can identify two 

8 Corresponding Polymers for a particular Fluorotelomer Product, the Panel shall so state, and 

9 provide a detailed explanation as to why it is appropriate to use the two Corresponding 

10 Polymers in the biodegradation studies.

11 iii. If, based upon such comparison, the Panel cannot identify 

12 two Corresponding Polymers for each Fluorotelomer Product and recommends that all three 

13 Corresponding Polymers for a particular Fluorotelomer Product be used in the biodegradation 

14 studies, the Panel shall so state, and provide a detailed explanation as to why it is appropriate to 

15 use all three Corresponding Polymers in the biodegradation studies.

16 iv. If, based upon such comparison, the Panel cannot identify 

17 any Corresponding Polymers for a Fluorotelomer Product and recommends that no 

18 Corresponding Polymer be used in the biodegradation studies, the Panel shall so state, and 

19 provide a detailed explanation as to why it is not appropriate to use any Corresponding 

20 Polymers in the biodegradation studies.

21 v. The Panel shall also advise EPA as to whether the 

22 laboratory should run a 14-day pilot test for SCAS on each of the Corresponding Polymers that 

23 it recommends should be used in the biodegradation studies but which were not pilot tested by 
Exhibit 1

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1 the laboratory performing the biodegradation work.

2 d. Advise EPA regarding which analytes that were measured for in 

3 the pilot tests should also be measured for in the biodegradation studies.

4 e. Evaluate the results of the SCAS studies performed on the 

5 Fluorotelomer Products and any Corresponding Polymers, and advise EPA as to what the results 

6 mean, both for the individual substances and for the group of test substances as a whole.

7 f. Provide comment on whether 14C labeling or other methods would 

8 enhance the characterization of the test substances, measurement of the potential for 

9 biodegradation, and/or the evaluation of the biodegradation study results. If so, the Panel 

10 should describe how, and in what ways, the use of 14C-radiolabeled Lab-scale Synthesized 

11 Fluorotelomer Product would increase the usefulness of the results of the characterization and 

12 biodegradation studies.

13 3. EPA, after consultation with DuPont, may submit additional, timely 

14 charges to the Panel that relate to, and are consistent with, the purposes of this Biodegradation

15 SEP.

16 4. The Panel Administrator may request a clarification from EPA regarding 

17 the charges set forth in Section V.A.2, above. Such request must be made in writing. The Panel 

18 Administrator will provide DuPont a copy of its written request and EPA will provide DuPont 

19 with a copy of its written response to the request, in accordance with Section V.E.8, below.

20 B. Requirements of Panel Input. The Panel will provide input to EPA on an 

21 advisory basis; such input will be provided by way of a summary document that reflects the 

22 individual opinions of the Panel members. The Panel Administrator may designate fewer than 

23 all members of the Panel to participate in providing advice on specific charges. Accordingly, at 
Exhibit 1

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39

1 different times during the Peer Consultation process, the Panel may be composed of different 

2 experts appropriate to the issue(s), but shall only be composed of the experts that have been 

3 selected by the Panel Administrator to serve as members of this Peer Consultation Panel. While 

4 consensus is not required, an accurate summary of all opinions expressed by the individual 

5 members must be submitted to EPA. The Panel will not operate under a consensus-based 

6 process but rather should identify areas of agreement and disagreement, and provide 

7 supporting scientific rationale. While EPA will consider the advice and recommendations it 

8 receives from the Panel, EPA is not bound by such advice or recommendations.

9 C. Qualifications and Requirements for Panel Members

10 1. The Panel must be composed of scientific experts who, collectively, have 

11 extensive and broad experience relevant to such areas as conducting and/or assessing 

12 biodegradation testing and environmental fate of polymers, and laboratory analysis and 

13 characterization of polymers and fluorochemicals. Specific knowledge of fluorotelomer 

14 chemistry is desirable.

15 2. Panel members must have sufficient technical expertise to make 

16 meaningful contributions to science-based evaluations.

17 3. Examples of the types of expertise that will be needed include, but are not 

18 limited to, conducting biodegradation testing, environmental fate, polymer chemistry, 

19 analytical chemistry under 40 C.F.R. Part 792, and/or fluorotelomer/ fluoropolymer chemistry. 

20 D. General Requirements for the Peer Consultation Process

21 1. One Panel will be selected by the Panel Administrator and shall be 

22 composed of at least four (4) but no more than eight (8) members collectively meeting the 

23 qualifications stated in Section V.C.
Exhibit 1

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1 2. In selecting the Panel, the Panel Administrator shall use conflict of interest 

2 guidelines approved by EPA. DuPont shall have an opportunity to review and provide 

3 comments to EPA regarding the conflict of interest guidelines.

4 3. The Panel Administrator shall submit information to Administrative 

5 Record (AR) 226 to ensure that the public has an opportunity to nominate panel members, access 

6 to the Panel’s sanitized final reports, and access to all sanitized laboratory final reports. The 

7 Panel Administrator shall not disclose any information that would be Toxic Substances Control 

8 Act Confidential Business Information if submitted to EPA.

9 4. Panel meetings and deliberations will not be open to the public but will be 

10 open to DuPont and EPA employees and/or contractors with Toxic Substances Control Act 

11 Confidential Business Information clearance. Such Panel meetings and/or deliberations may 

12 also be open to other individuals or entities that EPA would like to attend, subject to 

13 confidentiality agreements, and prior approval from DuPont.

14 5. If practicable, Panel meetings and deliberations will be held at or near the 

15 facilities of the laboratory conducting work relevant to the charge or charges under consideration 

16 at such meetings and/or deliberations so that Panel members can visit the laboratory, as 

17 needed.

18 6. EPA and DuPont may submit written comments to the Panel 

19 Administrator regarding technical documents developed by the laboratories under 

20 consideration by the Peer Consultation Panel. The Panel Administrator shall not provide such 

21 written comments to Panel members in advance of any Panel meetings or deliberations but 

22 only provide such comments to the Panel members at the time of the Panel meetings or 

23 deliberations so as not to bias the Panel members’ premeeting consideration of any particular 
Exhibit 1

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41

1 issue under consideration.

2 E. Selection and Responsibilities of the Panel Administrator

3 1. By February 1, 2006, the parties will agree to the Panel Administrator.

4 2. By March 15, 2006, DuPont must provide EPA with a final draft of the 

5 proposed contract that DuPont and the Panel Administrator have negotiated. The contract shall 

6 not be executed by DuPont and the Panel Administrator until EPA has reviewed and either 

7 approved or accepted the contract. The contract shall provide for appropriate confidentiality 

8 provisions.

9 3. Within seven (7) business days from receipt of EPA’s approval (or 

10 acceptance) of the proposed contract, DuPont must sign and forward the contract to the Panel 

11 Administrator for execution.

12 a. DuPont and the Panel Administrator shall seek to execute the 

13 contract within twenty-one (21) days of DuPont’s receipt of EPA’s approval (or acceptance) of 

14 the proposed contract. If DuPont and the Panel Administrator have not executed the contract 

15 within twenty-one (21) days of DuPont’s receipt of EPA’s approval (or acceptance) of the 

16 proposed contract in accordance with Section II.G.2, DuPont must inform EPA of the delay, 

17 explain the reason for the delay, provide a reasonable estimate as to when the contract will be 

18 executed, and exercise its right to an automatic extension provided in Section II.L, above. 

19 However, if DuPont believes that, notwithstanding its best efforts, the candidate Panel 

20 Administrator will not execute the contract with DuPont, DuPont shall provide notice to EPA of 

21 the impasse. EPA reserves the right to contact such candidate Panel Administrator, upon receipt 

22 of such notice from DuPont, to inquire why it has not entered into the contract with DuPont. If 

23 DuPont and the candidate Panel Administrator have not entered into a contract within fourteen 
Exhibit 1

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1 (14) days after EPA’s inquiry, unless EPA and DuPont agree to a longer time period, then the 

2 parties shall follow the approach set forth in Section V.E.4, below.

3 b. Within five (5) business days from the date that DuPont and the 

4 Panel Administrator execute the contract, DuPont must notify EPA that it has entered into the 

5 contract with the Panel Administrator.

6 4. If no Panel Administrator enters into a contract with DuPont, the Directors 

7 of the Office of Civil Enforcement and the Office of Pollution Prevention and Toxics shall 

8 meet with DuPont to discuss appropriate changes that can be made to this Biodegradation SEP 

9 to foster Panel Administrator participation in the performance of this Biodegradation SEP. If 

10 the parties cannot agree to any such appropriate changes, or if after agreeing to such 

11 appropriate changes, no potential Panel Administrators enters into a contract with DuPont, this 

12 Biodegradation SEP shall be deemed to have ceased prior to its completion, in which case, 

13 DuPont shall not be subject to Section VII.3 of the CAFO but DuPont shall be subject to Section

14 VII.1 of the CAFO, and the parties may exercise Section VI of the CAFO even though this 

15 Biodegradation SEP is not deemed satisfactorily completed.

16 5. Peer Consultation Process Work Plan. Within sixty (60) days of contract 

17 execution, the Panel Administrator must submit to EPA a proposed work plan (including all 

18 applicable attachments) that addresses the following:

19 a. The process, schedule, and budget for implementing and 

20 administering the Peer Consultation process under this Biodegradation SEP from the date the 

21 Panel Administrator executes the contract with DuPont through the date that the Panel 

22 Administrator submits to EPA and AR226 (or EPA-HQ-OPPT-2011-0991 at Regulations.Gov 

23 if submitted on or after January 1, 2012) the Panel’s final report from the last Panel meeting.
Exhibit 1

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1 b. A description of the process for nominating and selecting the Panel 

2 members, in accordance with Section V.A. 1, above, and the rationale to be used in determining

3 how many experts to empanel to address the charges.

4 c. The schedule for the Panel to timely address the charges in Section 

5 V.A.2 to ensure the most efficient use of the Panel.

6 i. The Panel Administrator shall communicate with the 

7 laboratory performing the biodegradation testing to determine if it would be appropriate to 

8 have the Peer Consultation Panel review the results of the first pilot test for SCAS and, once the 

9 laboratory has begun the full biodegradation studies, the results of the SCAS studies for the 

10 first grouping of chemical substances identified in Attachment A, i.e., the three Fluorotelomer 

11 Products identified as the A group, and any Corresponding Polymers selected for testing, or 

12 any subsequent groupings identified in Attachment A, as appropriate. The Panel Administrator 

13 may seek a recommendation from the laboratory with regard to this issue and/or the Panel 

14 Administrator may make its own determination after reviewing the data as to whether it is 

15 appropriate to convene the Peer Consultation Panel to review such results or to delay the review 

16 until all pilot tests and all biodegradation studies are completed.

17 ii. Regardless of how Peer Consultation is handled with regard 

18 to reviewing the first pilot test results and biodegradation study results, all pilot tests and 

19 biodegradation studies shall be reviewed by the Peer Consultation Panel.

20 d. The proposed conflict of interest guidelines that will be used to 

21 screen potential Panel members. The Panel Administrator shall send the conflict of interest 

22 guidelines to DuPont concurrent with its submission to EPA. DuPont shall have fourteen (14) 

23 business days to provide comments to EPA regarding such conflict of interest guidelines.
Exhibit 1

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1 e. The proposed contract for the Panel members, including the 

2 proposed honorarium to be paid to each Panel member.

3 f. The proposed confidentially agreements for the Panel members.

4 g. The process that the Panel Administrator will use to draft, on 

5 behalf of the Panel, the Panel’s reports. The Panel Administrator must address the following:

6 i. The process and schedule for the Panel Administrator to 

7 compile comments from the Panel; and

8 ii. The process and schedule for the Panel Administrator to 

9 submit a draft of the document to the Panel members for their review and comment before such 

10 document becomes final.

11 h. The number and timing of the Panel’s meetings to address the 

12 charges identified in Section V.A.2. If the Panel Administrator would like to arrange a Panel 

13 meeting or deliberation at a laboratory located outside of North America, the Panel 

14 Administrator shall seek prior approval from EPA before arranging such meeting.

15 i. A discussion of any other function(s) not expressly stated herein but

16 that are necessary to implement and administer the Peer Consultation process under this 

17 Biodegradation SEP.

18 6. Within seven (7) days of receipt of EPA’s approval of the work plan, the 

19 Panel Administrator must commence the Peer Consultation process, as described in the EPA20 approved work plan.

21 7. The Panel Administrator is responsible for arranging Panel meetings 

22 and/or deliberations, and acting as facilitator during Panel meetings and/or deliberations; 

23 coordinating exchange of information to Panel members; submitting all Panel reports to EPA 
Exhibit 1

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45

1 and DuPont, with a copy of any such report and if there is CBI, a sanitized version of the 

2 report, submitted to AR 226 (if prior to January 1, 2012) or directed to EPA-HQ-OPPT-2011-

3 0991 at regulations.gov (if on or after January 1, 2012) within thirty (30) days after submittal 

4 of a report to EPA and DuPont; and for carrying out all other functions necessary to implement 

5 and administer the Peer Consultation process under this Biodegradation SEP. 

6 8. Information Exchange. When the Panel Administrator provides any 

7 information in oral or written form to EPA or DuPont concerning the Peer Consultation 

8 process, the Panel Administrator shall provide such information to the other party in the same 

9 form as soon as practicable. The Panel Administrator is not responsible for sharing 

10 information it receives in oral or written form from EPA or DuPont; the party providing such 

11 information to the Panel Administrator shall concurrently provide the information in the same 

12 form to the other party. However, when the Panel Administrator receives a substantive oral or 

13 written communication from DuPont or EPA that impacts the Panel Administrator’s 

14 implementation and/or administration of the Peer Consultation process, it shall notify both 

15 parties of the communication and provide a brief written description of the content of the 

16 communication. 

17 9. Recommendations, Advice, and Conclusions of the Panel

18 a. Final Panel Reports submitted to the Parties. Within forty-five 

19 (45) days of each Panel meeting, the Panel Administrator shall submit a final written report, on 

20 behalf of the Panel, to EPA and DuPont, that addresses the charge or charges under 

21 consideration at such meeting.

22 b. Final Panel Reports submitted, as of January 1, 2012, for posting 

23 to EPA-HQ-OPPT-2011-0991. Within thirty (30) days after the Panel Administrator has 
Exhibit 1

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46

1 submitted a final written report to EPA and DuPont, such final written report and a sanitized 

2 version of such final written report shall be submitted to the person identified in Section V of 

3 the CAFO for posting on Regulations.gov at EPA-HQ-OPPT-2011-0991.

4 VI. ADDITIONAL ACTIVITIES 

5 A. If full scale SCAS testing is not initiated because of the “substantial equivalence” 

6 provisions of Section II.M. above, then DuPont shall spend up to $1,500,000.00 (one million 

7 five hundred thousand dollars), without exceeding the total five million dollar cost of the SEP, 

8 on purchasing approved items referenced in Section VI.B. below, or other items as approved 

9 by EPA, for the purpose of assisting others to perform research on whether Fluorotelomer 

10 Products degrade to produce PFOA or assisting in the identification and quantification of PFOA 

11 in humans and/or the environment. These items shall be donated to universities, state, or local 

12 laboratories. The EPA, in its unreviewable discretion, must approve each item and recipient 

13 prior to any purchase in order for it to be considered an eligible SEP cost. Any equipment 

14 purchase and donation will be made in accordance with the EPA 1998 SEP Policy (signed 

15 April 10, 1998). If SEP funds are remaining after implementing this provision, refer to Section 

16 VII.1 of the CAFO.

17 1. Timing and Manner of Initial Proposal. Within ninety (90) days after 

18 EPA provides written notification to DuPont that full scale SCAS testing should not 

19 commence, DuPont shall propose in writing by email and via first class mail, return receipt 

20 requested, or by commercial delivery service with documented delivery, to the person 

21 identified in Section V of the CAFO, what items it intends to purchase, when the items will be 

22 bought, the name and address of the recipient of each item and a detailed cost estimate for the 

23 EPA to consider. 
Exhibit 1

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1 2. Timing and Manner of Subsequent Proposals. If EPA rejects an item 

2 or recipient in the initial proposal by DuPont, then any subsequent proposals shall be submitted 

3 in the same manner and to the same person as set forth above, except that subsequent proposals 

4 shall be submitted within forty-five (45) days of receiving written notice from EPA that a 

5 proposed item or recipient has not been approved.

6 3. Timing of Purchase and Delivery of Approved Items. An item shall be 

7 approved for purchase to the proposed recipient when DuPont receives written notice of such 

8 approval from EPA. DuPont shall order the approved item for shipment to the approved 

9 recipient within ninety (90) days of receiving EPA’s written approval to make such a purchase. 

10 Delivery of the purchased items shall be set to occur within ninety (90) days after the purchase 

11 order is placed, unless EPA approves an extension.

12 B. DuPont may purchase analytical instruments for the purpose of Gas 

13 Chromatography/Mass Spectrometry and Liquid Chromatography/Mass Spectrometry. DuPont 

14 may also purchase reference standards as described below, including but not limited to 

15 substances listed in SEP Appendix A Attachment B Table 1 Characterization of Fluorotelomer 

16 Products and Corresponding Polymers. Additional substances include: 10-2 Fluorotelomer 

17 Acrylate (10-2 FTAc), 12-2 Fluorotelomer Acrylate (12-2 FTAc), 8-2 Fluorotelomer Acetate 

18 (8-2 FTOH Acetate), 10-2 Fluorotelomer Acetate (10-2 FTOH Acetate), 12-2 Fluorotelomer 

19 Acetate, 8-2 Fluorotelomer Aldehyde (8-2 FTAL) and 8-2 Unsaturated fluorotelomer Aldehyde 

20 (FTUAL), Mass labeled fluorotelomer acids (e.g., M+2 , M+4 PFOA), Mass labeled 

21 fluorotelomer alcohols (e.g., M+4 6-2, 8-2, and 10-2 FTOH), Mass labeled fluorotelomer 

22 aldehydes (e.g. 8:2 FTAL and FTUAL)

23 C. Upon EPA approval, DuPont may complete the SEP through the purchase of up to 
Exhibit 1

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48

1 $1,500,000 (one million five hundred thousand dollars), without exceeding the total five 

2 million dollar cost of the SEP, of the approved items in this section VI.B. if it has completed 

3 one or more Purified Fluorotelomer Products and one or more of the Lab-scale Synthesized 

4 Fluorotelomer Products through full scale definitive SCAS testing. The EPA shall only 

5 approve such a request if it determines that additional SCAS testing is not feasible with the 

6 remaining budget or that the public interest is best served through the expenditure on the 

7 approved items instead of additional activities. Any equipment purchase and donation will be 

8 made in accordance with the SEP Policy. If SEP funds are remaining after implementing this 

9 provision, refer to Section VII.1 of the CAFO. 

10 VII. MISCELLANEOUS

11 A. Eligible SEP Costs

12 1. The cost for providing sufficient quantities, as described in Sections II.D13 E, above, of the Fluorotelomer Products for characterization, biodegradation pilot tests, and 

14 biodegradation studies shall not be an eligible SEP Cost.

15 2. The cost of preparing sufficient quantities, as described in Sections II.D-E, 

16 for characterization of Corresponding Polymers identified for pilot testing in Attachment A, 

17 and up to two additional Corresponding Polymers that the Panel recommends pursuant to 

18 charge V.A.2.c, shall not be an eligible SEP Cost.

19 3. The cost of preparing sufficient quantities, as described in Sections II.D-E, 

20 for biodegradation pilot tests of the Corresponding Polymers, as identified on Attachment A, 

21 shall not be an eligible SEP cost.

22 4. The cost of preparing sufficient quantities, as described in Sections II.D-E,

23 for biodegradation studies of up to two of the Corresponding Polymers that the Panel identifies
Exhibit 1

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49

1 pursuant to charge V.A.2.c, shall not be an eligible SEP cost.

2 B. The title, section headings, and sub-headings used in this Appendix A are 

3 intended by the parties to assist in reading the document and have no legal meaning or effect.

4 C. Unless otherwise indicated, the word “days” as used in this Appendix refers to 

5 calendar days.

6 D. Unless otherwise provided in this Appendix or its Attachments, terms shall have 

7 the same meaning as provided in 15 U.S.C §§ 2601 et seq. and 40 C.F.R. Parts 2 and 792. 

8 Terms not defined in 15 U.S.C §§ 2601 et seq. and 40 C.F.R. Parts 2 and 792, but that are 

9 defined in this Appendix or its Attachments, shall be given the meaning as defined in this 

10 Appendix or its Attachments.

11 E. Except as otherwise provided, all communications between the parties, including 

12 DuPont’s third party contractors, shall be in writing.