Revised 12.18.08 

1 

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 PROJECT

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

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

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

11 Section III of the Consent Agreement and Final Order (“CAFO”) in TSCA-HQ-2004-0016, et al., 

12 entered into between DuPont and the United States Environmental Protection Agency (“EPA” or 

13 “Agency”) (collectively, “the parties”). This Appendix describes the SEP activities that DuPont will 

14 conduct to the extent that applicable funding allows. 

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

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

17 entity that DuPont contracts with to fulfill DuPont’s obligations under this SEP, to comply with the 

18 requirements of this Appendix and Attachments A-H. 

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

20 the degradation potential of the nine commercial fluorotelomer-based products identified in 

21 Attachment A to this Appendix (“the Fluorotelomer Products” or “Fluorotelomer Products”) as well 

22 as the degradation potential of corresponding synthesized or purified polymers equivalent to the 

23 Fluorotelomer Products with respect to the chemical composition that creates their fluorotelomer 

24 functionality (“Corresponding Polymers”). Eight of the nine Fluorotelomer Products to be tested 
2 

1 under this Biodegradation SEP are fluorotelomer-based polymers, while the ninth is a fluorotelomer2 based phosphate ester. The Fluorotelomer Products are products that were sold by DuPont prior to 

3 the date DuPont signs the Consent Agreement, and that DuPont will provide as the chemical 

4 substances to be tested pursuant to this Biodegradation SEP. An understanding of the degradation 

5 potential of the Fluorotelomer Products will be developed by considering the results of semi6 continuous activated sludge (SCAS) studies. Accordingly, this Biodegradation SEP is designed to 

7 provide information on the inherent biodegradation potential of the Fluorotelomer Products and 

8 their Corresponding Polymers using SCAS. 

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

10 exposed to activated sludge microorganisms in an aerated, aqueous medium with periodic settling of 

11 the solids and renewal of the aqueous phase with fresh media and test substance. The laboratory 

12 will run the test for twelve (12) weeks and will measure analytes that are indicative of degradation 

13 by determining the amount and rate of formation of observed degradation product(s) in the 

14 aqueous, sludge, and gas phases. Performing SCAS on the Fluorotelomer Products and then 

15 comparing the results to the same study performed on their Corresponding Polymers will enable a 

16 close look at the potential aerobic biodegradation of each of the Fluorotelomer Products. The test 

17 also gives an indication of the potential for removal of the test substances via sorption to the 

18 activated sludge inoculum. 

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

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

21 environment, such as fire fighting foams, as well as soil, stain, and grease resistant coatings on 

22 carpets, textiles, paper, and leather. Fluorotelomer products are aqueous dispersions. They 
3 

1 originate from fluorotelomer iodides [F(CF2CF2)n-I; where n= 3,4,5 commonly] which are 

2 commercially made by reacting pentafluoroethyl iodide with tetrafluoroethylene to create even3 number-carbon polyfluoroalky iodides. Although the telomerization process can be used to 

4 produce odd-number-carbon raw materials, those are not intentionally made or sold by DuPont. 

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

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

7 fluorotelomer alcohols [F-(CF2-CF2)n-CH2-CH2-OH, n = 2,3,4,5 etc.] that are then appended to an 

8 organic or inorganic moiety that contains the fluorotelomer as a functional group. As an example, 

9 fluorotelomer acrylate monomers [F-(CF2-CF2)n-CH2-CH2-O-C(O)-CH=CH2, n = 3,4,5 

10 commonly] are copolymerized with one or more of a group of hydrocarbon monomers to create an 

11 acrylic polymer with fluorotelomer functionality. The most common fluorotelomer raw material 

12 used in DuPont’s fluorotelomer products is the family of fluorotelomer alcohols. These alcohols 

13 are generally further transformed into polymeric and non-polymeric fluorotelomer-based products. 

14 This Biodegradation SEP involves the testing of polymeric and non-polymeric fluorotelomer 

15 products based on these common fluorotelomer intermediates; any reference in this Biodegradation 

16 SEP to DuPont’s commercial Fluorotelomer Products and their Corresponding Polymers is a 

17 reference to both the polymeric and non-polymeric products. 

18 DuPont generally manufactures product concentrates as aqueous dispersions of 

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

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

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

22 DuPont commercial Fluorotelomer Products being tested as part of this Biodegradation SEP are 
4 

1 thus analogous to paint concentrates and the finished articles to a cured paint surface. Evaluations 

2 of these biodegradation studies carried out on DuPont’s Fluorotelomer Products for the purpose of 

3 attempting to assess the biodegradation potential of cured fluorotelomer-based polymer products 

4 would need to be carefully done given the differences between the cured and uncured 

5 fluorotelomer-based products. Substances made with fluorotelomer functionality should not be 

6 referred to as either “perfluorinated” or “fluoropolymers” as these terms describe other materials. 

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

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

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

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

11 “Corresponding Polymers”). 

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

13 Attachment H – Purification Procedure Agreement (PPA) for each of the Fluorotelomer Products 

14 listed in Attachment A (“Purified Fluorotelomer Product”). DuPont and EPA have agreed on the 

15 procedure(s) that DuPont will use to purify the Fluorotelomer Products to produce the Purified 

16 Fluorotelomer Products, taking into consideration the need to optimize various factors, including 

17 the appropriate duration of extraction and redispersion processes, the desired purity of the Purified 

18 Fluorotelomer Products, the schedule for delivery of the Purified Fluorotelomer Products to the 

19 laboratories for characterization, testing and studies, and the overall schedule for completing this 

20 Biodegradation SEP. The PPA represents the agreement reached between EPA and DuPont 

21 concerning the procedure to be used to produce the Purified Fluorotelomer Products. Reporting on 

22 the production of the Purified Fluorotelomer Products shall be in accordance with the reporting 
5 

1 provisions of the PPA.

2 b. A synthesized fluorotelomer product containing a purified polymer, 

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

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

5 c. A synthesized fluorotelomer product containing a purified polymer, 

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

7 laboratory using high purity raw materials (“Lab-scale Synthesized Fluorotelomer Product”). 

8 3. Timing of Test Substance Transfer. 

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

10 performing biodegradation and (2) the laboratory performing characterization, DuPont shall 

11 transfer the sufficient quantities, as described in Sections II.D, below, of the nine Fluorotelomer 

12 Products to such laboratories. 

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

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

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

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

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

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

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

20 each laboratory’s EPA-approved work plan. 

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

22 II.E., below. 
6 

1 4. Third Party Laboratory Contract: Characterization. Contract with a Third 

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

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

4 selected by EPA for biodegradation studies according to Attachment B parameters to help inform 

5 the results of the biodegradation studies. The characterization of these Fluorotelomer Products and 

6 Corresponding Polymers, discussed in greater detail in Attachment B, will determine, using the 

7 most accurate instrumentation and procedures available as of the time of testing, and the best 

8 achievable precision, the amount of residual monomers and oligomers, other residuals, and the 

9 molecular weight distribution of polymeric material in the Fluorotelomer Products and 

10 Corresponding Polymers. 

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

12 Party Laboratory (“laboratory”) to: 

13 a. Pilot test the Fluorotelomer Products and Corresponding Polymers, as 

14 identified in Attachment A, following study guidelines for modified semi-continuous activated 

15 sludge (SCAS). SCAS pilot testing shall begin by the laboratory no later than January 31, 2010. 

16 b. Perform SCAS studies on the Fluorotelomer Products and any 

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

18 c. The laboratory will conduct the SCAS studies on the Fluorotelomer 

19 Products and any of their Corresponding Polymers in order to investigate the degradation potential 

20 of these Fluorotelomer Products to produce perfluorooctanoic acid (PFOA) or other analytes 

21 identified in Attachment C, and to determine the potential, if any, for their Corresponding 

22 Polymers to degrade to form PFOA or other analytes identified in Attachment C. 
7 

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

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

3 Biodegradation SEP. As discussed in greater detail in Section V, a Peer Consultation Panel will be 

4 involved in this Biodegradation SEP at specified milestones. 

5 F. Applicability of Results. Because this Biodegradation SEP is designed to examine (1) 

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

7 Polymers and (2) the biodegradation potential and fate of the Fluorotelomer Products and their 

8 Corresponding Polymers under aerobic sewage treatment plant simulation conditions, it does not 

9 address the biodegradation potential of the Fluorotelomer Products or their Corresponding 

10 Polymers in soil, sediments, landfills, or aquatic or marine systems, nor does it address degradation 

11 under anaerobic conditions. Additionally, using the results of this Biodegradation SEP to attempt 

12 to assess the biodegradation potential of cured polymers would need to be carefully done given the 

13 differences between cured and uncured fluorotelomer-based products. 

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

15 for biodegradation. According to OECD Guidance on the Use of the Globally Harmonized System 

16 for the Classification of Chemicals which are Hazardous for the Aquatic Environment (April 

17 2001), a positive result in an inherent biodegradation test indicates that the test substance will not 

18 persist indefinitely in the environment; however, rapid and complete biodegradation cannot be 

19 assumed. A negative result in an inherent biodegradation test does not definitively demonstrate that 

20 a chemical will not biodegrade under any conditions, but rather that the chemical will not 

21 biodegrade under the conditions of the test. Aerobic sewage treatment simulation tests are designed 

22 to yield information on the behavior of chemicals in aerobic sewage treatment plants. These tests 
8 

1 permit the measurement of the rates of loss of the test chemical, formation and identification of 

2 degradation products, partitioning of these chemicals to sludge solids, and volatilization under 

3 conditions controlled to mimic those found in full-scale aerobic wastewater treatment systems. The 

4 results from these studies are indicative of how the test substance will behave in full-scale 

5 systems. 

6 II. GENERAL OBLIGATIONS AND REQUIREMENTS

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

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

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

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

11 and will use its best efforts to satisfactorily complete this Biodegradation SEP, within the 

12 meaning of Section IV.4 of the CAFO, no later than December 27, 2011 (“SEP Completion 

13 Date”). No later than sixty (60) days prior to the SEP Completion Date, if DuPont believes that it 

14 will be unable to satisfactorily complete the SEP within such time period, DuPont shall petition 

15 EPA to extend the SEP Completion Date based upon DuPont’s assertion of good cause to extend 

16 such date. The Office of Civil Enforcement, in consultation with the Office of Pollution Prevention 

17 and Toxics, will review DuPont's petition and meet with DuPont to discuss its petition. The Office 

18 of Civil Enforcement, in consultation with the Office of Pollution Prevention and Toxics, shall 

19 determine whether DuPont has demonstrated that there is good cause to extend the SEP 

20 Completion Date and, if determining that DuPont has demonstrated good cause, determine how 

21 long to extend the SEP Completion Date.

22 C. Good Laboratory Practices and Study Monitor. For purposes of this Biodegradation 
9 

1 SEP, with regard to characterization and biodegradation testing and studies, DuPont and its 

2 contractors shall be subject to, and must comply with, 40 C.F.R. Part 792. Each laboratory 

3 conducting research under this Biodegradation SEP shall designate a Study Director in 

4 accordance with 40 C.F.R. § 792.33. DuPont shall designate a Study Monitor that will serve as the 

5 point of contact for EPA and the laboratories. 

6 D. Supply of Test Substances to Laboratories. DuPont shall provide the laboratory that it 

7 contracts with to perform characterization and the laboratory that it contracts with to perform the 

8 biodegradation studies, sufficient quantities of the Fluorotelomer Products, identified in 

9 Attachment A, and any Corresponding Polymers, to perform all of the tests and studies discussed 

10 in this Biodegradation SEP for which such laboratory has been contracted to perform. Sufficient 

11 quantities of the Corresponding Polymers, identified in Attachment A for pilot testing, must 

12 include the quantities necessary to perform characterization, the pilot tests, and biodegradation 

13 studies, even if such Corresponding Polymers are not selected by EPA to be used in the 

14 biodegradation studies. Each Fluorotelomer Product and Purified Fluorotelomer Product that 

15 DuPont provides to the laboratory performing characterization must be from the same production 

16 batch as provided to the laboratory performing the biodegradation studies. Each Synthesized 

17 Fluorotelomer Product and Lab-scale Synthesized Fluorotelomer Product that DuPont provides to 

18 the laboratory performing characterization must be from the same laboratory batch as provided to 

19 the laboratory performing biodegradation testing. 
10 

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

2 Fluorotelomer Products identified in Attachment A, and Corresponding Polymers, to 

3 replicate the characterization and biodegradation studies (i.e., SCAS tests (including pilots)) 

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

5 • Sufficient quantities for EPA of the Fluorotelomer Products identified in 

6 Attachment A, the nine Synthesized Fluorotelomer Products, and the nine 

7 Lab-scale Synthesized Fluorotelomer Products shall be shipped by DuPont to 

8 a laboratory identified by EPA (per SEP A Section II.H.) on or before 

9 November 18, 2008 and 

10 • Sufficient quantities for EPA of the Purified Fluorotelomer Products resulting 

11 from the PPA shall be shipped by DuPont no later than fourteen (14) days 

12 after sparging ceases for each such Product or by June 1, 2009, whichever 

13 occurs first. Further details on the quantities to be shipped, the specific 

14 timing for shipment, and shipment location are set forth in Section II.B.4. of 

15 the PPA. 

16 All test substances shall be provided to EPA following the chain of custody procedures in 

17 Attachment D, except that quart jars acceptable under DOT regulations may be substituted 

18 for the 30 mL containers. DuPont shall develop appropriate holding procedures for the test 

19 substances to assure the chemical integrity of such substances. These appropriate holding 

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

21 the test substance to the EPA-identified laboratory. 

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

1 SEP, DuPont or a laboratory transfers either Fluorotelomer Products, Corresponding 

2 Polymers, or other chemicals to a laboratory or to EPA, DuPont and/or such 

3 laboratory(ies) are required to follow the chain of custody procedures in Attachment D of 

4 this Appendix. 

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

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

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

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

9 report, relating to performance of this Biodegradation SEP. 

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

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

12 will provide such comments to DuPont within a reasonable amount of time, commensurate 

13 with the type and nature of the document or submission being reviewed. 

14 2. All of EPA’s comments, including requested changes, to a document or 

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

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

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

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

19 days of DuPont’s receipt of such comments. In this notification to EPA, DuPont shall 

20 explain why it believes that EPA’s comments do not relate to the performance of this 

21 Biodegradation SEP and that such comments are not required to be incorporated into the 

22 document. EPA shall consider DuPont’s explanation before making a final decision 
12 

1 regarding whether such comments relate to the performance of this Biodegradation SEP; 

2 provided, however, that EPA will not unreasonably require DuPont to modify or remove 

3 from any such contract or agreement any provision that requires the contractor to indemnify 

4 DuPont for stipulated penalties that DuPont pays under Section VII.4 of the CAFO as a 

5 result of the contractor’s failure to perform work in accordance with a schedule to which the 

6 contractor has agreed. 

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

8 proposed contract, proposed confidentiality agreement, or proposed protocol opt to accept 

9 such a document without formally approving it. If EPA exercises this option, EPA will 

10 notify DuPont that the proposed contract or proposed confidentiality agreement has been 

11 accepted. 

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

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

14 via first class mail, return receipt requested, or by commercial delivery service with 

15 documented delivery, to the person identified in Section V of the CAFO. All submissions 

16 shall be provided in electronic format on a compact disc (CD). All submissions shall be 

17 accompanied by a cover letter in hardcopy, that describes the contents of the CD, and 

18 complies with any other requirements of the CAFO. EPA will specify, in advance of the 

19 transfer of test substances addressed in Section II.E, above, where to transfer such divided 

20 samples. 

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

22 provided to EPA containing Confidential Business Information (“CBI”) must also be provided 
13 

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

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

3 Peer Consultation Panel, and SEP Completion Reports submitted pursuant to Section IV of 

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

5 submission of the sanitized version. Note that this Section II.I governs over CAFO Section 

6 V.9. with respect to the timing for submittal of sanitized final laboratory reports, final Peer 

7 Consultation Panel reports, and the SEP Completion Report. 

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

9 and biodegradation studies must be performed in the following manner and in compliance 

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

11 change, or if EPA, after consultation with DuPont, determines that a change is appropriate: 

12 1. DuPont shall use one laboratory to characterize the Fluorotelomer Products, 

13 the Corresponding Polymers identified in Attachment A for pilot testing, and any 

14 Corresponding Polymers that EPA selects for biodegradation studies, in accordance with 

15 Attachment B. 

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

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

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

19 Fluorotelomer Products and any Corresponding Polymers that EPA selects for 

20 biodegradation studies, following both the sequence, and grouping (to maximize laboratory 

21 efficiency, capacity allowing) provided in Attachment A. 

22 b. If, based on their submissions in response to the Request for 
14 

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

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

3 laboratory is willing to contractually commit to, completing all of the biodegradation studies 

4 (including pilots) by no later than September 1, 2011 (or such longer time as EPA approves), 

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

6 i. DuPont shall use one laboratory identified in Attachment G to 

7 perform the biodegradation studies but not the analytical component of the studies, and 

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

9 the Fluorotelomer Products and any Corresponding Polymers under this Biodegradation 

10 SEP, as a subcontractor for the analytical component of the biodegradation studies; or 

11 ii. DuPont shall propose two laboratories identified in Attachment 

12 G to perform the biodegradation studies and shall propose how to divide the biodegradation 

13 work between the two laboratories, subject to EPA approval. 

14 3. Pilot Testing 

15 a. The laboratory performing the biodegradation studies shall conduct 

16 one 14-day pilot test for SCAS on each of the Fluorotelomer Products that have been 

17 selected for pilot testing as identified in Attachment A, and shall conduct one 14-day pilot 

18 test for SCAS on each of the Corresponding Polymers that have been selected for pilot 

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

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

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

22 and any Corresponding Polymers. 
15 

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

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

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

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

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

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

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

8 and recommendations on appropriate final protocols for the laboratory to use for the 

9 biodegradation studies and (2) comments and recommendations regarding which of the 

10 Corresponding Polymers should be used in the biodegradation studies. EPA will review the 

11 Panel report and any comments that DuPont has submitted to EPA pursuant to Section II.K, 

12 below. EPA will then transmit its comments and judgments to DuPont and require DuPont to 

13 direct the laboratory to develop a final protocol, within a specified timeframe, to be 

14 submitted to EPA for approval. The final protocol that the laboratory develops shall consider 

15 the Panel report and EPA’s comments and judgments. The laboratory shall not commence 

16 the biodegradation studies until it has received EPA’s approval of the final protocol and 

17 EPA’s determination regarding which of the Corresponding Polymers shall be used in the 

18 biodegradation studies. 

19 K. At any time during the performance of this Biodegradation SEP, DuPont may 

20 provide comments to EPA regarding the following technical documents: protocols, test 

21 methods, analytical methods (and any modifications of such technical documents), and the 

22 Panel report addressing the charge set forth in Section V.A.2.b. To be eligible for 
16 

1 consideration by EPA, DuPont must submit such comments to EPA within seven (7) 

2 business days of DuPont’s receipt of the technical document. EPA reserves the right to 

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

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

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

6 cause shown. 

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

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

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

10 other than the SEP Completion Date, DuPont shall be entitled to a first extension as a matter 

11 of right, provided that DuPont submits a written notice to EPA that it is exercising this 

12 provision, no later than one business day prior to the deadline. 

13 a. For deadlines of thirty (30) days or less, DuPont shall 

14 automatically receive an extension equal to the number of days initially provided in this 

15 Appendix. 

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

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

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

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

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

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

22 (30) days, for good cause shown. 
17 

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

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

3 with a third party to perform, if, after exercising its right to an automatic extension provided 

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

5 extension shall be granted provided that DuPont’s Study Monitor sent a written notice to the 

6 third party no later than five (5) business days before the deadline, and DuPont requests an 

7 extension no later than one (1) business day prior to the deadline. In exercising this 

8 provision, DuPont shall furnish EPA with the written notice that it sent to the third party. 

9 a. For deadlines of thirty (30) days or less, DuPont shall 

10 receive an extension equal to the number of days initially provided in this Appendix. 

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

12 30-day extension unless DuPont requests, and EPA approves, an extension greater than 

13 thirty (30) days, for good cause shown. 

14 3. Additional Extensions. DuPont’s request for an extension other than the 

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

16 deadline that does not involve work that DuPont has contracted with a third party to 

17 perform, or (b) a third request for an extension of a deadline that does involve work that 

18 DuPont has contracted with a third party to perform, or (c) subsequent requests for extensions 

19 of deadlines addressed in Sections II.L.3.a-b, such requests are subject to EPA’s discretion, 

20 and granted for good cause shown. In granting a request for an extension under Section 

21 II.L.3, EPA may grant an extension of time different from the amount of time requested by 

22 DuPont. 
18 

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

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

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

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

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

6 submission, DuPont will be entitled to an extension to perform the required action. The 

7 extension shall be equal to the number of days of EPA’s review and approval of the 

8 submission and shall be calculated from the date that EPA received such submission through 

9 the date that EPA transmitted its approval of the submission to DuPont. If, during its review 

10 and prior to its approval, EPA requests that DuPont make changes to the submission, in 

11 calculating the extension, the parties shall not include the amount of time for DuPont to 

12 make such changes and resubmit the document to EPA for approval. Such time excluded 

13 from the extension shall start from the date that EPA transmits the requested changes to 

14 DuPont through the date that EPA receives the amended submission, incorporating the 

15 requested changes. But, such time excluded from the extension shall not include time during 

16 which EPA is still reviewing a portion of the submission for which EPA has also requested 

17 changes. If an extension is granted under this provision, DuPont may still request an 

18 extension of the extended deadline under Sections II.L.1-3, above. 

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

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

21 concerning the extension of deadlines. 
19 

1 

2 III. SELECTION OF THIRD PARTY LABORATORIES

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

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

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

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

7 provide the laboratories listed in Attachment G with a confidentiality agreement and request 

8 that such confidentiality agreement be signed and returned by a date certain consistent with 

9 the deadlines established in this Appendix. 

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

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

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

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

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

15 testing). 

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

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

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

19 E of this Appendix. 

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

21 the laboratory to develop a firm cost estimate, with pricing, for the work that the laboratory 

22 is solicited to perform, which must include such information as the identity, structure, and 
20 

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

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

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

4 a. Laboratories receiving the RFP for characterization of the 

5 Fluorotelomer Products and Corresponding Polymers must provide cost estimates for 

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

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

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

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

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

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

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

13 of the required analytical work associated with the characterization or biodegradation studies 

14 required under this Biodegradation SEP. 

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

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

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

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

19 deadlines and criteria set forth in this Appendix. 

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

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

22 7. Notice that failure to submit a proposal meeting all of the criteria in the 
21 

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 

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

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

7 the RFP, DuPont shall notify EPA why it cannot send the RFP to such laboratory. EPA 

8 reserves the right to contact such laboratory to inquire why it has not returned the 

9 confidentiality agreement and, if such laboratory agrees within seven (7) business days of 

10 contact by EPA to sign and submit the confidentiality agreement to DuPont, DuPont shall 

11 then provide the RFP to the laboratory. 

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

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

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

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

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

17 proposal to EPA concurrent with its submission to DuPont. 

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

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

20 laboratory to inquire why it has not submitted a proposal to DuPont. If the laboratory 

21 indicates that it wants to submit a proposal, the laboratory must do so by a date to be specified 

22 by EPA, which shall not be longer than fourteen (14) days after contact by EPA, unless the 
22 

1 parties agree to a longer time period. 

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

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

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

5 characterization of the Fluorotelomer Products and Corresponding Polymers, and the 

6 laboratory that DuPont would like to use to perform the biodegradation studies of the 

7 Fluorotelomer Products and Corresponding Polymers. 

8 1. DuPont must provide EPA with a detailed rationale describing 

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

10 the other laboratories that submitted a proposal to perform such work. 

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

12 modified SCAS studies on the Fluorotelomer Products and Corresponding Polymers. DuPont 

13 shall contract with only one laboratory to characterize the Fluorotelomer Products and 

14 Corresponding Polymers. 

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

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

17 with a written rationale for the rejection and require DuPont to propose a different laboratory 

18 from which DuPont has received a proposal. The parties will continue this process until EPA 

19 agrees to DuPont’s laboratory selection. 

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

21 proposals submitted is acceptable to EPA, the Directors of the Office of Civil Enforcement 

22 and the Office of Pollution Prevention and Toxics shall meet with DuPont to discuss 
23 

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

2 participation in the performance of this Biodegradation SEP. EPA and DuPont shall first 

3 implement the alternative approach set forth in Section II.J.2.b before EPA considers whether 

4 to expand the list of potential laboratories identified in Attachment G to include foreign 

5 laboratories. If the parties cannot agree to any such appropriate changes, or if after agreeing to 

6 such appropriate changes, no laboratories submit a proposal, this Biodegradation SEP shall be 

7 deemed to have ceased prior to its completion, in which case, DuPont shall not be subject to 

8 Section VII.3 of the CAFO but DuPont shall be subject to Section VII.1 of the CAFO, and 

9 the parties may exercise Section VI of the CAFO even though this Biodegradation SEP is not 

10 deemed satisfactorily completed. 

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

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

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

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

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

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

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

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

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

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

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

22 request from EPA for written information from a laboratory pertaining to work it is 
24 

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

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

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

4 provide such information to EPA and DuPont within three (3) business days of DuPont’s 

5 Study Monitor’s notice to the laboratory. 

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

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

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

9 DuPont to instruct the laboratory to implement the change immediately and continue 

10 running the test. DuPont may submit comments for EPA’s consideration regarding such 

11 modification, in accordance with Section II.K, above. 

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

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

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

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

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

17 and re-run the test implementing the modification. DuPont may submit comments for 

18 EPA’s consideration regarding such modification, in accordance with Section II.K, above. 

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

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

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

22 and the QAPPs. DuPont may submit comments for EPA’s consideration regarding such 
25 

1 technical documents, in accordance with Section II.K, above. 

2 d. Material Modifications. Any proposed material modification that 

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

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

5 Biodegradation SEP, a material modification is an adjustment to the work conducted under 

6 this Biodegradation SEP made in the normal course of implementing such work that would 

7 result in a substantive alteration of the biodegradation studies or other activities conducted 

8 under this Biodegradation SEP. 

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

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

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

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

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

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

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

16 comments for EPA’s consideration regarding such modification, in accordance with Section 

17 II.K, above. 

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

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

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

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

22 notice to EPA and DuPont within twenty-four (24) hours of such modification. If, based 
26 

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

2 that the laboratory should implement an additional change, EPA will require DuPont to 

3 instruct the laboratory to provide EPA and DuPont with all data generated up to that date and 

4 either immediately terminate the test and re-run the test or immediately implement the 

5 additional change. DuPont may submit comments for EPA’s consideration regarding such 

6 modification or additional change, in accordance with Section II.K, above. 

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

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

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

10 with a progress report that describes the technical work performed, a copy of the raw data 

11 generated up to that date, and costs incurred. 

12 h. Information Exchange. When the laboratory provides any 

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

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

15 as practicable. The laboratory is not responsible for disseminating information that it 

16 receives in written form from DuPont; DuPont shall concurrently provide the information to 

17 EPA. When the laboratory provides information in oral form to EPA or DuPont concerning 

18 the laboratory’s work under this Biodegradation SEP, the laboratory shall communicate such 

19 information to the other party as soon as practicable. The laboratory is not responsible for 

20 communicating information it receives in oral form from DuPont or EPA; each party shall 

21 communicate such information to the other party. However, when the laboratory receives 

22 an oral communication from DuPont or EPA, it shall notify both parties and provide a brief 
27 

1 written description of such oral communication. To the extent practicable, the parties shall 

2 jointly communicate orally with the laboratory in light of the laboratory’s obligation to 

3 prepare a written notification to the parties when it receives an oral communication, not 

4 jointly, from either party. 

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

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

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

8 SEP. 

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

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

11 sign and forward the contract to the laboratory for execution. 

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

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

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

15 inform EPA of the delay, explain the reason for the delay, provide a reasonable estimate as to 

16 when the contract will be executed, and exercise its right to an automatic extension in 

17 Section II.L, above. After exercising its right to an automatic extension in Section II.L, but 

18 before a second request for an extension under Section II.L, if DuPont believes that, 

19 notwithstanding its best efforts, the laboratory will not enter into the contract with DuPont, 

20 DuPont shall provide notice to EPA of the impasse. EPA reserves the right to contact such 

21 laboratory, upon receipt of such notice from DuPont, to inquire why the laboratory has not 

22 entered into the contract with DuPont. If DuPont and the laboratory have not entered into a 
28 

1 contract within fourteen (14) days EPA’s inquiry, unless DuPont and EPA agree to a longer 

2 time period, then the parties shall follow the approach set forth in Section III.H, below. 

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

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

5 contract with the laboratory. 

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

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

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

9 laboratory participation in the performance of this Biodegradation SEP. If the parties cannot 

10 agree to any such appropriate changes, or if after agreeing to such appropriate changes, no 

11 laboratories enter into a contract with DuPont, this Biodegradation SEP shall be deemed to 

12 have ceased prior to its completion, in which case, DuPont shall not be subject to Section 

13 VII.3 of the CAFO but DuPont shall be subject to Section VII.1 of the CAFO, and the parties 

14 may exercise Section VI of the CAFO even though this Biodegradation SEP is not deemed 

15 satisfactorily completed. 

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

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

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

19 IV. TESTS TO BE PERFORMED ON DUPONT’S FLUOROTELOMER 

20 PRODUCTS AND CORRESPONDING POLYMERS

21 A. Characterization of the Fluorotelomer Products and Corresponding Polymers 

22 1. As provided in Section III.I, the laboratory shall commence the work 
29 

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

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

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

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

5 work under this Biodegradation SEP (including Attachment B), and a general schedule and 

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

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

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

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

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

11 EPA- approved work plan. 

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

13 Fluorotelomer Product and any Corresponding Polymers, the laboratory shall provide EPA 

14 and the Panel Administrator, a Certificate of Analysis, as provided in Attachment F, as 

15 well as the protocols and a copy of the raw data. The laboratory shall provide the QAPP to 

16 the Panel Administrator with the first Certificate of Analysis but need not provide the 

17 QAPP for the remaining eight Fluorotelomer Products and Corresponding Polymers. 

18 B. Biodegradation Studies: SCAS 

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

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

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

22 work by submitting a work plan to EPA that describes the work the laboratory has been 
30 

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

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

3 work. Within ninety (90) days from the date that DuPont and the laboratory execute the 

4 contract to perform work under this Biodegradation SEP, the laboratory shall submit to EPA 

5 all relevant technical documents that require EPA’s approval. 

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

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

8 EPA-approved work plan. 

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

10 weeks. The inoculum source shall be activated sludge mixed liquor from a municipal 

11 wastewater treatment plant operating in compliance with its National Pollutant Elimination 

12 Discharge System (“NPDES”) permit. Settled domestic sewage from a municipal wastewater 

13 treatment plant operating in compliance with its NPDES permit shall be used as feed. Daily 

14 samples of the aqueous phase, sludge solids, and off gas shall be collected, analyzed, and 

15 quantified for the analytes listed in Attachment C of this Biodegradation SEP. If at any time 

16 EPA determines, or if DuPont or the laboratory recommends and EPA determines, that daily 

17 sampling is not necessary, EPA will notify DuPont to instruct the laboratory of a change in 

18 the sampling schedule and establish a new timeframe for sampling. Analyses shall be 

19 conducted using the most accurate instrumentation and procedures available as of the time of 

20 testing. All analytical methods shall be approved by EPA prior to the start of the studies. 

21 3. The laboratory shall conduct one 14-day pilot test for SCAS on each of 

22 the Fluorotelomer Products that have been selected for pilot testing as identified in 
31 

1 Attachment A, and shall conduct one 14-day pilot test for SCAS on each of the 

2 Corresponding Polymers that have been selected for pilot testing as identified in Attachment 

3 A, to develop test data that can inform protocol decisions and to establish that these 

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

5 the biodegradation potential of the Fluorotelomer Products and Corresponding Polymers. 

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

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

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

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

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

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

12 design and protocols for the SCAS studies, the laboratory shall begin the biodegradation 

13 studies following the sequence and groupings (capacity allowing) provided in Attachment 

14 A. 

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

16 Attachment C for purposes of the biodegradation studies. 

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

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

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

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

21 if any, shall be used in the biodegradation studies. 

22 6. Study Preliminary Reports. Within seven (7) business days of the 
32 

1 laboratory completing the biodegradation studies on the first Fluorotelomer Product and any 

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

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

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

5 Consultation Panel. 

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

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

8 QAPP to the Panel Administrator with the first Fluorotelomer Product and any of its 

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

10 Corresponding Polymers). 

11 b. As the laboratory completes biodegradation studies on each 

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

13 and Corresponding Polymers), the laboratory shall submit preliminary reports and 

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

15 Panel Administrator for distribution to the Peer Consultation Panel. 

16 C. Reporting Test and Study Results 

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

18 the final report for the tests that it performs. 

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

20 Panel Administrator within thirty (30) days of completing all of the work identified in its 

21 contract with DuPont. 
33 

1 

2 V. PEER CONSULTATION FOR TESTS PERFORMED ON DUPONT’S 

3 FLUOROTELOMER PRODUCTS AND CORRESPONDING POLYMERS

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

5 shall contract with an independent third party to serve as a Panel Administrator to implement 

6 and administer the Peer Consultation process under this Biodegradation SEP. 

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

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

9 a. The Panel Administrator shall solicit potential Panel member 

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

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

12 b. After receiving Panel member nominations, the Panel 

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

14 comment by EPA, DuPont, and the public. 

15 c. After considering all comments received regarding the Panel 

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

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

18 to select the Panel. If both parties, independently, recommend to the Panel Administrator that 

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

20 Administrator shall remove such individual from the potential Panel and from the pool, 

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

22 new potential Panel to EPA and DuPont for comment. The Panel Administrator shall follow 
34 

1 this approach until it has selected a final Panel. 

2 d. The Panel Administrator shall treat all comments received 

3 under Sections V.A.1.b and V.A.1.c as confidential. 

4 2. The Panel is charged to: 

5 a. Review the approved or accepted protocols that the 

6 laboratory used to characterize the Fluorotelomer Products and Corresponding Polymers 

7 for chemical characteristics, compositional analysis, oligomeric content, molecular weight 

8 distribution, and residual content as discussed in Attachment B of this Biodegradation SEP 

9 and determine: 

10 i. whether the approved or accepted protocols 

11 were sufficiently robust to provide reliable characterization data, and 

12 ii. whether the laboratory correctly followed the 

13 protocols. 

14 b. Review the design and approved or accepted protocol that 

15 was used to run each pilot and results for each pilot to provide comments and 

16 recommendations for developing a final design and protocol for SCAS studies that will be 

17 approved by EPA prior to implementation by the laboratory. 

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

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

20 Polymer to advise EPA regarding the similarities and differences of the Corresponding 

21 Polymers as compared to the Fluorotelomer Products, and which, if any, of the Corresponding 

22 Polymers should be used in the biodegradation studies. 
35 

1 i. If, based upon such comparison, the Panel can 

2 identify one Corresponding Polymer for each Fluorotelomer Product that should be used in 

3 the biodegradation studies, the Panel shall so state, and provide a detailed explanation as to 

4 why it is appropriate to use only this one Corresponding Polymer in the biodegradation 

5 studies. 

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

7 identify 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 

12 identify two Corresponding Polymers for each Fluorotelomer Product and recommends that 

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

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

15 it is appropriate to use all three Corresponding Polymers in the biodegradation studies. 

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

17 identify 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 

22 the laboratory should run a 14-day pilot test for SCAS on each of the Corresponding 
36 

1 Polymers that it recommends should be used in the biodegradation studies but which were 

2 not pilot tested by the laboratory performing the biodegradation work. 

3 d. Advise EPA regarding which analytes that were 

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

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

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

7 results mean, both for the individual substances and for the group of test substances as a 

8 whole. 

9 f. Provide comment on whether 14C labeling or other 

10 methods would enhance the characterization of the test substances, measurement of the 

11 potential for biodegradation, and/or the evaluation of the biodegradation study results. If so, 

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

13 Synthesized Fluorotelomer Product would increase the usefulness of the results of the 

14 characterization and biodegradation studies. 

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

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

17 Biodegradation SEP. 

18 4. The Panel Administrator may request a clarification from EPA 

19 regarding the charges set forth in Section V.A.2, above. Such request must be made in 

20 writing. The Panel Administrator will provide DuPont a copy of its written request and 

21 EPA will provide DuPont with a copy of its written response to the request, in accordance 

22 with Section V.E.8, below. 
37 

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

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

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

4 than all members of the Panel to participate in providing advice on specific charges. 

5 Accordingly, at different times during the Peer Consultation process, the Panel may be 

6 composed of different experts appropriate to the issue(s), but shall only be composed of the 

7 experts that have been selected by the Panel Administrator to serve as members of this Peer 

8 Consultation Panel. While consensus is not required, an accurate summary of all opinions 

9 expressed by the individual members must be submitted to EPA. The Panel will not operate 

10 under a consensus-based process but rather should identify areas of agreement and 

11 disagreement, and provide supporting scientific rationale. While EPA will consider the 

12 advice and recommendations it receives from the Panel, EPA is not bound by such advice or 

13 recommendations. 

14 C. Qualifications and Requirements for Panel Members 

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

16 have extensive and broad experience relevant to such areas as conducting and/or 

17 assessing biodegradation testing and environmental fate of polymers, and laboratory 

18 analysis and characterization of polymers and fluorochemicals. Specific knowledge of 

19 fluorotelomer chemistry is desirable. 

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

21 meaningful contributions to science-based evaluations. 

22 3. Examples of the types of expertise that will be needed include, but are 
38 

1 not limited to, conducting biodegradation testing, environmental fate, polymer chemistry, 

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

3 chemistry. 

4 D. General Requirements for the Peer Consultation Process 

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

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

7 qualifications stated in Section V.C. 

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

9 interest guidelines approved by EPA. DuPont shall have an opportunity to review and 

10 provide comments to EPA regarding the conflict of interest guidelines. 

11 3. The Panel Administrator shall submit information to Administrative 

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

13 access to the Panel’s sanitized final reports, and access to all sanitized laboratory final 

14 reports. The Panel Administrator shall not disclose any information that would be Toxic 

15 Substances Control Act Confidential Business Information if submitted to EPA. 

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

17 will be open to DuPont and EPA employees and/or contractors with Toxic Substances 

18 Control Act Confidential Business Information clearance. Such Panel meetings and/or 

19 deliberations may also be open to other individuals or entities that EPA would like to 

20 attend, subject to confidentiality agreements, and prior approval from DuPont. 

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

22 facilities of the laboratory conducting work relevant to the charge or charges under 
39 

1 consideration at such meetings and/or deliberations so that Panel members can visit the 

2 laboratory, as needed. 

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

4 Administrator regarding technical documents developed by the laboratories under 

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

6 such written comments to Panel members in advance of any Panel meetings or 

7 deliberations but only provide such comments to the Panel members at the time of the 

8 Panel meetings or deliberations so as not to bias the Panel members’ premeeting 

9 consideration of any particular issue under consideration. 

10 E. Selection and Responsibilities of the Panel Administrator 

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

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

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

14 shall not be executed by DuPont and the Panel Administrator until EPA has reviewed and 

15 either approved or accepted the contract. The contract shall provide for appropriate 

16 confidentiality provisions. 

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

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

19 Panel Administrator for execution. 

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

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

22 acceptance) of the proposed contract. If DuPont and the Panel Administrator have not 
40 

1 executed the contract within twenty-one (21) days of DuPont’s receipt of EPA’s approval 

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

3 inform EPA of the delay, explain the reason for the delay, provide a reasonable estimate as 

4 to when the contract will be executed, and exercise its right to an automatic extension 

5 provided in Section II.L, above. However, if DuPont believes that, notwithstanding its best 

6 efforts, the candidate Panel Administrator will not execute the contract with DuPont, DuPont 

7 shall provide notice to EPA of the impasse. EPA reserves the right to contact such candidate 

8 Panel Administrator, upon receipt of such notice from DuPont, to inquire why it has not 

9 entered into the contract with DuPont. If DuPont and the candidate Panel Administrator 

10 have not entered into a contract within fourteen (14) days after EPA’s inquiry, unless EPA 

11 and DuPont agree to a longer time period, then the parties shall follow the approach set 

12 forth in Section V.E.4, below. 

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

14 and the Panel Administrator execute the contract, DuPont must notify EPA that it has 

15 entered into the contract with the Panel Administrator. 

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

17 Directors of the Office of Civil Enforcement and the Office of Pollution Prevention and 

18 Toxics shall meet with DuPont to discuss appropriate changes that can be made to this 

19 Biodegradation SEP to foster Panel Administrator participation in the performance of this 

20 Biodegradation SEP. If the parties cannot agree to any such appropriate changes, or if after 

21 agreeing to such appropriate changes, no potential Panel Administrators enters into a 

22 contract with DuPont, this Biodegradation SEP shall be deemed to have ceased prior to its 
41 

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

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

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

4 completed. 

5 5. Peer Consultation Process Work Plan. Within sixty (60) days of 

6 contract execution, the Panel Administrator must submit to EPA a proposed work plan 

7 (including all applicable attachments) that addresses the following: 

8 a. The process, schedule, and budget for implementing and 

9 administering the Peer Consultation process under this Biodegradation SEP from the date the 

10 Panel Administrator executes the contract with DuPont through the date that the Panel 

11 Administrator submits to EPA and AR226 the Panel’s final report from the last Panel 

12 meeting. 

13 b. A description of the process for nominating and selecting 

14 the Panel members, in accordance with Section V.A. 1, above, and the rationale to be used in 

15 determining how many experts to empanel to address the charges. 

16 c. The schedule for the Panel to timely address the 

17 charges in Section V.A.2 to ensure the most efficient use of the Panel. 

18 i. The Panel Administrator shall communicate with 

19 the laboratory performing the biodegradation testing to determine if it would be appropriate 

20 to have the Peer Consultation Panel review the results of the first pilot test for SCAS and, 

21 once the laboratory has begun the full biodegradation studies, the results of the SCAS studies 

22 for the first grouping of chemical substances identified in Attachment A, i.e., the three 
42 

1 Fluorotelomer Products identified as the A group, and any Corresponding Polymers selected 

2 for testing, or any subsequent groupings identified in Attachment A, as appropriate. The 

3 Panel Administrator may seek a recommendation from the laboratory with regard to this 

4 issue and/or the Panel Administrator may make its own determination after reviewing the 

5 data as to whether it is appropriate to convene the Peer Consultation Panel to review such 

6 results or to delay the review until all pilot tests and all biodegradation studies are completed. 

7 ii. Regardless of how Peer Consultation is handled 

8 with regard to reviewing the first pilot test results and biodegradation study results, all pilot 

9 tests and biodegradation studies shall be reviewed by the Peer Consultation Panel. 

10 d. The proposed conflict of interest guidelines that will be 

11 used to screen potential Panel members. The Panel Administrator shall send the conflict of 

12 interest guidelines to DuPont concurrent with its submission to EPA. DuPont shall have 

13 fourteen (14) business days to provide comments to EPA regarding such conflict of interest 

14 guidelines. 

15 e. The proposed contract for the Panel members, including 

16 the proposed honorarium to be paid to each Panel member. 

17 f. The proposed confidentially agreements for the Panel 

18 members. 

19 g. The process that the Panel Administrator will use to draft, 

20 on behalf of the Panel, the Panel’s reports. The Panel Administrator must address the 

21 following: 

22 i. The process and schedule for the Panel 

23 Administrator to compile comments from the Panel; and 
43 

1 ii. The process and schedule for the Panel 

2 Administrator to submit a draft of the document to the Panel members for their review and 

3 comment before such document becomes final. 

4 h. The number and timing of the Panel’s meetings to address 

5 the charges identified in Section V.A.2. If the Panel Administrator would like to arrange a 

6 Panel meeting or deliberation at a laboratory located outside of North America, the Panel 

7 Administrator shall seek prior approval from EPA before arranging such meeting. 

8 i. A discussion of any other function(s) not expressly stated 

9 herein but that are necessary to implement and administer the Peer Consultation process 

10 under this Biodegradation SEP. 

11 6. Within seven (7) days of receipt of EPA’s approval of the work plan, the 

12 Panel Administrator must commence the Peer Consultation process, as described in the 

13 EPA-approved work plan. 

14 7. The Panel Administrator is responsible for arranging Panel meetings 

15 and/or deliberations, and acting as facilitator during Panel meetings and/or deliberations; 

16 coordinating exchange of information to Panel members; submitting all Panel reports to 

17 EPA and DuPont, with a copy of any such report and if there is CBI, a sanitized version of 

18 the report, submitted to AR 226 within thirty (30) days after submittal of a report to EPA 

19 and DuPont; and for carrying out all other functions necessary to implement and 

20 administer the Peer Consultation process under this Biodegradation SEP. 

21 8. Information Exchange. When the Panel Administrator provides any 

22 information in oral or written form to EPA or DuPont concerning the Peer Consultation 
44 

1 process, the Panel Administrator shall provide such information to the other party in the 

2 same form as soon as practicable. The Panel Administrator is not responsible for sharing 

3 information it receives in oral or written form from EPA or DuPont; the party providing such 

4 information to the Panel Administrator shall concurrently provide the information in the 

5 same form to the other party. However, when the Panel Administrator receives a substantive 

6 oral or written communication from DuPont or EPA that impacts the Panel Administrator’s 

7 implementation and/or administration of the Peer Consultation process, it shall notify both 

8 parties of the communication and provide a brief written description of the content of the 

9 communication. 

10 9. Recommendations, Advice, and Conclusions of the Panel 

11 a. Final Panel Reports submitted to the Parties. Within 

12 forty-five (45) days of each Panel meeting, the Panel Administrator shall submit a final 

13 written report, on behalf of the Panel, to EPA and DuPont, that addresses the charge or 

14 charges under consideration at such meeting. 

15 b. Final Panel Reports submitted to AR 226. Within thirty 

16 (30) days after the Panel Administrator has submitted a final written report to EPA and 

17 DuPont, such final written report and a sanitized version of such final written report shall be 

18 submitted to AR 226. 

19 VI. MISCELLANEOUS

20 A. Eligible SEP Costs 

21 1. The cost for providing sufficient quantities, as described in Sections 

22 II.D-E, above, of the Fluorotelomer Products for characterization, biodegradation pilot 
45 

1 tests, and biodegradation studies shall not be an eligible SEP Cost. 

2 2. The cost of preparing sufficient quantities, as described in Sections II.D3 E, for characterization of Corresponding Polymers identified for pilot testing in Attachment 

4 A, and up to two additional Corresponding Polymers that the Panel recommends pursuant 

5 to charge V.A.2.c, shall not be an eligible SEP Cost. 

6 3. The cost of preparing sufficient quantities, as described in Sections II.D7 E, for biodegradation pilot tests of the Corresponding Polymers, as identified on Attachment 

8 A, shall not be an eligible SEP cost. 

9 4. The cost of preparing sufficient quantities, as described in Sections II.D10 E, for biodegradation studies of up to two of the Corresponding Polymers that the Panel 

11 identifies pursuant to charge V.A.2.c, shall not be an eligible SEP cost. 

12 B. The title, section headings, and sub-headings used in this Appendix A are 

13 intended by the parties to assist in reading the document and have no legal meaning or 

14 effect. 

15 C. Unless otherwise indicated, the word “days” as used in this Appendix refers 

16 to calendar days. 

17 D. Unless otherwise provided in this Appendix or its Attachments, terms shall have 

18 the same meaning as provided in 15 U.S.C §§ 2601 et seq. and 40 C.F.R. Parts 2 and 792. 

19 Terms not defined in 15 U.S.C §§ 2601 et seq. and 40 C.F.R. Parts 2 and 792, but that are 

20 defined in this Appendix or its Attachments, shall be given the meaning as defined in this 

21 Appendix or its Attachments. 

22 E. Except as otherwise provided, all communications between the parties, 
46 

1 including DuPont’s third party contractors, shall be in writing.