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I. PRELIMINARY STATEMENT 

1. EPA initiated this proceeding for the assessment of civil penalties, pursuant to the 

Toxic Substances Control Act (“TSCA”), 15 U.S.C. §§ 2601 et seq., and the Resource 

Conservation and Recovery Act (“RCRA”), as amended by the Hazardous and Solid Waste 

Amendments of 1984 (“HSWA”), 42 U.S.C. §§ 6901 et seq., and RCRA’s implementing 

regulations. 

2. The parties are entering into this Consent Agreement to resolve the violations alleged 

in the First Amended Complaint, incorporated by reference in its entirety into this document, and 

the Second Complaint, also incorporated by reference in its entirety into this document, referred 

jointly in this Consent Agreement as the “Consolidated Action.” Respondent has entered into 

this Consent Agreement in order to resolve this matter, to avoid unnecessary business disruption, 

and to avoid the necessity of litigation. Nothing in this Consent Agreement should be taken as 

an admission of liability by Respondent or an admission as to any issue of fact or law raised by 

Complainant’s allegations in the Consolidated Action unless specifically stated below. 

3. In the Consolidated Action, Complainant alleges that on three separate occasions as 

described in Counts I, II and IV of the First Amended Complaint and Second Complaint, 

Respondent failed to comply with the requirements of TSCA §§ 8(e) and 15, 15 U.S.C. 

§§ 2607(e) and 2614. As stated in its Answers to the First Amended Complaint and the Second 

Complaint, which are incorporated in their entirety into this document, Respondent denies these 

allegations. 

4. The Complainant further alleges that, as described in Count III of the First Amended 

Complaint, Respondent violated RCRA § 3005(a), 42 U.S.C. § 6925(a), 40 C.F.R. § 270.30(h), 

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1 and West Virginia Hazardous Waste Management Rule § 33-20-11.1, and Part 1, Section I.7 of 

2 the Corrective Action portion of DuPont’s hazardous waste permit for the Washington Works 

3 Facility located in Washington, West Virginia. As stated in its Answer to the First Amended 

4 Complaint, which is incorporated by reference in its entirety into this document, Respondent 

5 denies this allegation. 

6 5. This Consent Agreement and Final Order shall apply to, and be binding upon, 

7 Respondent, its officers, directors, employees, successors and assigns, including, but not limited 

8 to, subsequent purchasers. 

9 6. For the purpose of this proceeding, Respondent will not contest EPA’s jurisdiction to 

10 settle this action and to enter into this Consent Agreement and Final Order. 

11 7. For the purpose of this proceeding, Respondent waives any right to contest the 

12 allegations in either the Consolidated Action or this Consent Agreement and waives its right to 

13 appeal or to seek judicial review of the Final Order accompanying this Consent Agreement. 

14 8. Without admitting the factual or legal allegations contained in the Consolidated 

15 Action, except as stated in Paragraphs 6 and 7, above, Respondent consents to the terms of this 

16 Consent Agreement and Final Order. 

17 II. ADDITIONAL ALLEGED VIOLATIONS RESOLVED IN THIS 

18 CONSENT AGREEMENT AND FINAL ORDER 

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20 1. The parties agree to settlement of the following alleged violations before the filing of 

21 a complaint, pursuant to TSCA § 16, 15 U.S.C. § 2615, and 40 C.F.R. § 22.13(b). 

22 2. Respondent is alleged to have violated, on four separate occasions, TSCA §§ 8(e) and 

23 15, 15 U.S.C. §§ 2607(e) and 2614, as further described in Paragraphs II.3. – II.9., below. 

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3. Complainant alleges the following to form the factual basis for Count V: 

a. Sometime in 2002, a third party performed testing that would detect levels of 

perfluorooctanoic acid (PFOA) in the blood serum of ten individuals living in West Virginia. 

Because only one of these ten individuals reportedly had ever worked at DuPont’s Washington 

Works Plant, this exposure to PFOA is considered to be non-occupational. 

b. At the time this community serum sampling was performed, these ten 

individuals reportedly drank private well water located near one or more DuPont landfills at 

which DuPont disposed ammonium perfluorooctanoate (APFO), also referred to by Complainant 

as perfluorooctanoic acid (PFOA). The ten individuals also lived in the vicinity of DuPont’s 

Washington Works Plant in West Virginia. 

c. DuPont represents to EPA that at no time before August 13, 2004, did DuPont, 

including any of its officers, employees, contractors, and/or consultants, have knowledge of the 

2002 blood serum sampling results for these non-occupational individuals. 

d. On December 20, 2004, DuPont submitted to EPA the 2002 blood serum 

sampling results for these non-occupational individuals. 

4. Complainant alleges that Respondent should have immediately submitted the 2002 

blood serum sampling results for the ten non-occupational individuals, discussed in Paragraph 

II.3., above, when Respondent obtained this information. 

5. The following general factual allegations are relevant to, and incorporated in, 

Paragraphs II.6. – II.8., below: 

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a. In June 1991, EPA published the “TSCA Section 8(e) Reporting Guide” (1991 

Reporting Guide), in which EPA provided reporting guidance for determining when to report 

significant lethality observed in animal studies. 

b. The 1991 Reporting Guide establishes specific numeric values that correspond 

to the following three toxicity categories: extremely toxic, highly toxic, and moderately toxic. 

6. Complainant alleges the following to form the factual basis for Count VI: 

a. On or before July 11, 1997, DuPont performed an acute inhalation toxicity 

study for a perfluorinated chemical substance, the identity of which has been claimed as TSCA 

Confidential Business Information by DuPont. 

b. This acute inhalation toxicity study was performed on male rats which were 

exposed to the test substance in an aerosol form. The study results were compiled by DuPont in 

an internal document described as Report No. HL-1997-00599. 

c. On or before January 17, 2002, DuPont performed an acute inhalation toxicity 

study on male rats using the same perfluorinated chemical substance in the same form and 

exposure pathway as was used in the test described in subparagraph b, above, but at different 

concentrations than were used in the 1997 study. 

d. While DuPont submitted Report No. HL-1997-00599 to EPA on December 7, 

2004, DuPont had reported the results of the 2002 acute toxicity study to EPA on January 22, 

2002, which EPA designated as 8EHQ-0102-15057 in the TSCA §8(e) Docket. 

7. Complainant alleges the following to form the factual basis for Count VII: 

a. On or before July 11, 1997, DuPont performed an acute inhalation toxicity 

study on a perfluorinated chemical substance, different from the chemical substance at issue in 

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Count VI, above, the identity of which has been claimed as TSCA Confidential Business 

Information by DuPont. 

b. This acute inhalation toxicity study was performed on male rats which were 

exposed to the test substance in an aerosol form. The study results were compiled by DuPont in 

an internal document described as Report No. HL-1997-00600. 

c. DuPont submitted Report No. HL-1997-00600 to EPA on December 7, 2004. 

8. Complainant alleges the following to form the factual basis for Count VIII: 

a. On or before August 29, 1997, DuPont performed an acute inhalation toxicity 

study on a perfluorinated chemical substance, different from the chemical substance at issue in 

Counts VI and VII, above, the identity of which has been claimed as TSCA Confidential 

Business Information by DuPont. 

b. This acute inhalation toxicity study was performed on male rats which were 

exposed to the test substance in an aerosol form. The study results were compiled by DuPont in 

an internal document described as Report No. HL-1997-00598. 

c. DuPont submitted Report No. HL-1997-00598 to EPA on December 7, 2004. 

9. Under the 1991 Reporting Guide, where significant lethality occurs at a dose or 

concentration comparable to an acute inhalation LC50 value of less than or equal to 0.5 mg/l, 

which EPA equates to 500 mg/m3, the test substance is considered extremely toxic and the 

results of the study must be immediately reported to EPA. 

a. Complainant alleges that based upon the results of the study described in HL1997-00599 (which has been designated in EPA’s TSCA § 8(e) Docket as 8EHQ-1207-15856 

Supplement) discussed in Paragraph II.6., above, the test substance is extremely toxic under the 

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1991 Reporting Guide. Complainant alleges that Respondent should have immediately 

submitted the results of this study to EPA under TSCA § 8(e) when DuPont obtained this 

information. 

b. Complainant alleges that based upon the results of the study described in HL1997-00600 (which has been designated in EPA’s TSCA § 8(e) Docket as 8EHQ-1207-15856 

Supplement) discussed in Paragraph II.7., above, the test substance is extremely toxic under the 

1991 Reporting Guide. Complainant alleges that Respondent should have immediately 

submitted the results of this study to EPA under TSCA § 8(e) when DuPont obtained this 

information. 

c. Complainant alleges that based upon the results of the study described in HL1997-00598 (which has been designated in EPA’s TSCA § 8(e) Docket as 8EHQ-1207-15856 

Supplement) discussed in Paragraph II.8., above, the test substance is extremely toxic under the 

1991 Reporting Guide. Complainant alleges that Respondent should have immediately 

submitted the results of this study to EPA under TSCA § 8(e) when DuPont obtained this 

information. 

10. For the purpose of this proceeding, Respondent will not contest EPA’s jurisdiction to 

settle this action and to enter into this Consent Agreement and Final Order. 

11. For the purpose of this proceeding, Respondent neither admits nor denies the factual 

allegations, and denies the legal allegations, stated in Paragraphs II.2. – II.9., above. 

12. For the purpose of this proceeding, Respondent waives any right to contest these 

additional alleged violations, and waives its right to appeal or to seek judicial review of the Final 

Order accompanying this Consent Agreement. 

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1 III. TERMS OF SETTLEMENT 

2 1. Pursuant to TSCA § 16 and RCRA § 3008, the nature, circumstances and extent of the 

3 alleged violations, Respondent's agreement to perform Supplemental Environmental Projects 

4 (SEPs) and other relevant factors, Respondent agrees to pay ten million two hundred fifty 

5 thousand dollars ($10,250,000) in accordance with the terms set forth below in order to settle 

6 the allegations in the Consolidated Action and in Section II of this Consent Agreement. 

7 2. Without admitting any liability, Respondent enters into this Consent Agreement and 

8 consents for the purposes of settlement to ratification by the Environmental Appeals Board of the 

9 attached Final Order requiring the payment of the civil penalty cited in Paragraph III.1., above, 

10 and the performance of the SEPs in accordance with Section IV., below. 

11 3. Not more than thirty (30) days following the effective date of the Final Order, 

12 Respondent shall submit either a cashier's or certified check, payable to the order of the 

13 "Treasurer, United States of America," in the amount of ten million two hundred fifty 

14 thousand dollars ($ 10,250,000), to: 

15 EPA-Washington 

16 (Hearing Clerk) 

17 Docket No. TSCA-HQ-2004-0016, RCRA-HQ-2004-0016, 

18 TSCA-HQ-2005-5001 

19 P.O. Box 360277 

20 Pittsburgh, PA 15251-6277 

21 or pay ten million two hundred fifty thousand dollars ($10,250,000) by wire transfer with a 

22 notation of “DuPont, Civil Penalty Docket Nos. TSCA-HQ-2004-0016, RCRA-HQ-2004-0016, 

23 TSCA-HQ-2005-5001” by using the following instructions: 

8
 
1 Name of Beneficiary: EPA
 

2 Number of Account for deposit: 68010099
 

3 The Bank Holding Acct: Treas_NYC
 

4 The ABA routing Number: 021030004
 

5 4. Respondent shall provide, within fourteen (14) business days after making the
 

6 payment required in Paragraph III.3., a copy of the check or wire transfer letter to:
 

7 Mr. Tony Ellis 

8 US EPA - Headquarters (2245A) 

9 Office of Civil Enforcement 

10 1200 Pennsylvania Ave. N.W. 

11 Washington, DC 20460 

12 The check or wire transfer shall bear the case docket number. Interest and late charges shall be 

13 assessed as specified in Paragraph IX.2. 

14 5. The amount specified in Paragraph III.3., above, represents civil penalties assessed by 

15 EPA and shall not be deductible by DuPont for purposes of Federal taxes. 

16 IV. SUPPLEMENTAL ENVIRONMENTAL PROJECTS 

17 1. Respondent shall implement the two SEPs described in detail in Appendices A and B 

18 to this Consent Agreement, which have been approved by EPA and are attached hereto and 

19 incorporated into this Consent Agreement by reference. Respondent shall implement the two 

20 SEPs in accordance with the respective provisions set forth in Appendices A and B. Appendix A 

21 is entitled Fluorotelomer-based Product Biodegradation Testing. The total cost of this SEP 

22 (referred herein as “SEP A”) is set at five million dollars ($5,000,000). Appendix B is entitled 

23 Microscale Chemistry and Green Chemistry For Junior High Schools and High Schools in Wood 

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County, West Virginia. The total cost of this SEP (referred herein as “SEP B”) is set at one 

million two hundred fifty thousand dollars ($1,250,000). 

2. SEP Completion: Both SEPs shall be completed within the timeframes established in 

Appendices A and B. Therefore, SEP A is to be completed within the timeframe specified in, or 

extended in accordance with, Appendix A. SEP B is to be completed within the timeframe 

specified in, or extended in accordance with, Appendix B. 

3. In implementing the SEPs, Respondent shall incur eligible costs of not less than, and 

Respondent shall not be required to incur eligible costs in excess of, the amount indicated in 

Paragraph IV.1., above, for each SEP. Eligible SEP costs include the costs of planning and 

implementing the SEPs but do not include attorneys fees, the costs of employees performing 

functions that are part of their regular duties, certain potential additional management costs 

related to implementation of SEP B, as agreed to by the parties, and costs, if any, expressly 

specified in the applicable Appendices A and B as not eligible. 

4. Respondent is responsible for the satisfactory completion of the SEPs in accordance 

with the requirements of this Consent Agreement, its Appendices and attachments. “Satisfactory 

completion” or “satisfactorily completed” means that Respondent shall expend not less than the 

amount indicated for that SEP in Paragraph IV.1., above, on SEP activities described in 

Appendix A or B respectively and performed in accordance with the applicable Appendix A or B 

respectively. Although Respondent may use contractors or consultants in planning and 

implementing a SEP, Respondent always remains responsible for the satisfactory completion of 

the SEP. In performing activities under any of the SEPs, Respondent shall not be required to 

incur eligible costs in excess of the amount indicated for that SEP in Paragraph IV.1., above. 

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5. With regard to each of the SEPs, Respondent certifies the truth and accuracy of each 

of the following: 

a. that, as of the date of executing this Consent Agreement, all cost information 

provided to EPA in connection with EPA’s approval of each SEP is complete and 

accurate and represents a fair estimate of the costs necessary to implement the 

SEPs; 

b. that, as of the date of executing this Consent Agreement, Respondent is not 

required to perform or develop any of the SEPs by any federal, state, international 

or local law or regulation and is not required to perform or develop any of the 

SEPs by agreement, grant, or as injunctive relief awarded in any other action in 

any forum; 

c. that, as of the date of executing this Consent Agreement, each SEP is not a project 

that Respondent was planning or intending to perform or implement other than in 

settlement of the claims resolved in this Consent Agreement; 

d. that, as of the date of executing this Consent Agreement, Respondent has not 

received, and is not negotiating to receive, credit for any of the SEPs in any other 

enforcement action; and 

e. that Respondent will not receive any reimbursement for any portion of any SEP. 

6. SEP Completion Report: Not later than sixty (60) days after the date set for
 

completion of each SEP, or after Respondent has expended the amount indicated for that SEP in
 

Paragraph IV.1., above, on activities under the SEP, Respondent shall submit a SEP Completion
 

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Report to the person indicated in Paragraph V.1. The SEP Completion Report shall contain the 

following information: 

a. a detailed description of the SEP as implemented; 

b. a description of any problems encountered in completing the SEP and the 

solutions thereto; 

c. an itemized list of all eligible SEP costs; 

d. certification that either the SEP has been fully implemented pursuant to 

the provisions of this Consent Agreement and the applicable Appendix or 

that Respondent has expended the amount indicated for that SEP in 

Paragraph IV.1., above, in a good faith effort on activities under the SEP; 

and 

e. a description of the environmental and public health benefits resulting 

from implementation of the SEP (with a quantification of the benefits, if 

feasible). 

7. EPA may, in its sole discretion, require any information in addition to that described 

in the preceding Paragraph that is reasonably necessary in order to determine the adequacy of 

each SEP completion or eligibility of SEP costs, and Respondent shall provide such information 

within thirty (30) days, unless the parties agree that additional time is necessary to provide the 

information. 

8. Within sixty (60) days after receiving a SEP Completion Report, or if EPA does not 

receive a SEP Completion Report, within sixty (60) days after the date set for completion of the 

SEP or after Respondent has notified EPA that it has expended the amount indicated for that SEP 

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in Paragraph IV.1., above, on activities under the SEP, EPA shall notify Respondent whether or 

not Respondent has satisfactorily completed that SEP. If EPA notifies Respondent that a SEP is 

not satisfactorily completed, Respondent shall have ten (10) business days following receipt of 

such notice to object to the Agency’s determination. Respondent’s objection must be in writing 

and submitted to the person in Paragraph V.1. EPA and Respondent shall have an additional 

thirty (30) days from the receipt by EPA of Respondent’s objection to reach agreement on 

changes necessary to the SEP, during which period Respondent shall not be deemed to be in 

violation of this Consent Agreement. If the Parties cannot reach agreement on any such issue 

within this thirty (30) day period, EPA shall provide a written statement of its decision to 

Respondent, which decision shall be final. If the SEP has not been satisfactorily completed, 

stipulated penalties may be assessed under Section VII. of this Consent Agreement. If 

Respondent has satisfactorily completed all SEP activities described in the relevant Appendix 

but the amount expended on performance of the SEP is less than the amount indicated for that 

SEP in Paragraph IV.1., above, then negotiations shall occur as provided under Section VI. of 

this Consent Agreement. 

9. Each submission required under this Section shall be signed by an official with 

knowledge of the SEP and shall bear the certification language set forth in Paragraph V.4., 

below. 

10. Any public statement, oral or written, in print, film, or other media, made by 

Respondent making reference to the SEPs under this Consent Agreement shall include the 

following language: “This project was undertaken in connection with the settlement of an 

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1 enforcement action taken by the U.S. Environmental Protection Agency under the Toxic
 

2 Substances Control Act and the Resource Conservation and Recovery Act.”
 

3 V. REPORTING REQUIREMENTS
 

4 1. Respondent shall submit the following reports: 

5 a. Within thirty (30) days after the end of each calendar-year quarter (i.e., by April 30, 

6 July 31, October 30, and January 30) after execution of this Consent Agreement, until 

7 termination of this Consent Agreement pursuant to Paragraph IX.9., Respondent shall submit in 

8 writing to: 

9 Mr. Tony Ellis 

10 US EPA - Headquarters (2245A) 

11 Office of Civil Enforcement 

12 1200 Pennsylvania Ave., N.W. 

13 Washington, DC 20460* 

14 Phone: 202-564-4167 

15 Fax: 202-564-0035 

16 Email: ellis.tony@epa.gov 

17 (*Note: Above is for US Postal Service, 

18 courier deliveries use zip code 20004.) 

19 a quarterly report for the preceding quarter that shall include a discussion of Respondent’s 

20 progress in satisfying its obligations in connection with each SEP including, at a minimum, a 

21 narrative description of activities undertaken, compliance with the schedules or milestones set 

22 forth in the applicable Appendix, and a summary of costs incurred since the previous report. 

23 b. If Respondent violates, or has reason to believe that it probably will violate, any 

24 requirement of this Consent Agreement, including its Appendices, Respondent shall notify EPA 

25 of such violation and its likely duration, in writing, within ten (10) business days of the day 

26 Respondent first becomes aware of the violation, with an explanation of the violation’s likely 

27 cause and of the remedial steps taken, or to be taken, to prevent or minimize such violation. If 

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the cause of a violation cannot be fully explained at the time the report is due, Respondent shall 

so state in the report. Respondent shall investigate the cause of the violation and shall then 

submit an amendment to the report, including a full explanation of the cause of the violation, 

within thirty (30) days of the day Respondent becomes aware of the cause of the violation. 

During this thirty (30) day period Respondent shall not be deemed to be in violation of this 

Consent Agreement. Failure by Respondent to comply with the notice requirements of this 

Paragraph shall render this Paragraph void and of no effect as to the particular incident involved 

and constitute a waiver of the Respondent's right to request an extension of its obligation under 

this Consent Agreement based on such incident. Nothing in this Paragraph or the following 

Paragraph relieves Respondent of its obligation to provide the notice required by Paragraph IX.5. 

of this Consent Agreement (Force Majeure). 

2. Whenever any violation of this Consent Agreement or any other event affecting 

Respondent’s performance under this Consent Agreement may pose an immediate threat to the 

public health or welfare or the environment, Respondent shall notify EPA orally or by electronic 

or facsimile transmission as soon as possible, but no later than twenty-four (24) hours after 

Respondent first knew of, or should have known of, the violation or event. This procedure is in 

addition to the requirements set forth in the preceding Paragraph. 

3. All reports and notices required under this Consent Agreement or its 

Appendices shall be submitted to the person designated in Paragraph V.1.a. of this Consent 

Agreement. 

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1 4. Each report submitted by Respondent under this Section, each final report as defined 

2 in the applicable SEP, and each SEP Completion Report shall be signed by an official of the 

3 submitting party and include the following certification: 

4 I certify under penalty of law that I have examined and am familiar 

5 with the information submitted in this document and all attach6 ments and that this document and its attachments were prepared 

7 either by me personally or under my direction or supervision in a 

8 manner designed to ensure that qualified and knowledgeable 

9 personnel properly gather and present the information contained 

10 therein. I further certify, based on my personal knowledge or on 

11 my inquiry of those individuals immediately responsible for 

12 obtaining the information, that the information is true, accurate and 

13 complete. I am aware that there are significant penalties for 

14 submitting false information, including the possibility of fines and 

15 imprisonment for knowingly and willfully submitting a materially 

16 false statement. 

17 This certification requirement does not apply to emergency or similar notifications where 

18 compliance would be impractical. 

19 5. Respondent agrees that EPA may at reasonable times and in a reasonable manner 

20 inspect the locations of ongoing SEP activities at facilities owned by Respondent or owned or 

21 operated by any contractor or sub-contractor of Respondent who conducts SEP activities and 

22 observe the staff performance at any such location in order to confirm that each of the SEPs is 

23 being undertaken in conformity with the representations made herein. Respondent shall cause to 

24 be included in any contract or sub-contract for the conduct of SEP activities a provision 

25 requiring access for EPA inspection in accordance herewith. 

26 6. Respondent shall maintain for a period of five (5) years after termination of this 

27 Consent Agreement legible copies of documentation of the underlying research and data for any 

28 and all documents or reports submitted to EPA pursuant to this Consent Agreement or its 

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Appendices and shall provide the documentation of any such underlying research and data to 

EPA not more than thirty (30) days after a request for such information, unless otherwise stated 

in an Appendix. 

7. The reporting requirements of this Consent Agreement do not relieve Respondent of 

any reporting obligations required by any federal, state, or local law, regulation, permit, or other 

requirement. 

8. Any information provided pursuant to this Consent Agreement may be used by the 

United States in any proceeding to enforce the provisions of this Consent Agreement and as 

otherwise permitted by law. 

9. All SEP Completion Reports required under Paragraph IV.6., quarterly reports 

required in Paragraph V.1.a., and final reports as defined in the applicable SEP, shall be provided 

to EPA in a version that is immediately available for public review. Confidential Business 

Information (CBI), if any, shall be redacted by Respondent and a statement inserted for each 

redacted item in the public version that Respondent declares that information CBI. A CBI 

version of the report will be sent simultaneously with the public version. 

VI. EXPENDITURES LESS THAN AGREED SEP MINIMUMS 

1. If all activities under a SEP are satisfactorily completed, but Respondent expends less 

than the total amount agreed upon for the SEP, the parties shall either: 

a) negotiate additional SEPs or 

b) negotiate to redirect the remaining money to a SEP already agreed to as part of this 

Consent Agreement 

to adjust for the balance of the unexpended funds. 

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2. If the parties cannot agree to additional SEPs and cannot agree to redirect the money 

to a SEP already agreed to under this Consent Agreement, then Respondent shall be considered 

to have not satisfactorily completed the SEP even though all work is satisfactorily performed. 

VII. STIPULATED PENALTIES 

1. If a SEP is not satisfactorily completed only because Respondent expends less than 

the total amount agreed upon for the SEP and the parties did not agree under Paragraph VI.2. to 

direct the money to an additional SEP or redirect the money to an existing SEP already agreed to 

under this Consent Agreement, Respondent shall pay a stipulated penalty equal to the difference 

between the amount of eligible SEP costs incurred by the Respondent and the applicable amount 

set forth in Paragraph IV.3. 

2. If Respondent represents it has satisfactorily completed a SEP, but EPA notifies 

Respondent under Paragraph IV.8. that the SEP has not been satisfactorily completed for reasons 

other than, or in addition to, those set forth in Paragraph VII.1, Respondent shall pay a stipulated 

penalty equal to the amount of the SEP as specified in Paragraph IV.1., which penalty shall be in 

addition to any penalty required in Paragraph VII.1., above. 

3. If Respondent ceases work on a SEP prior to its completion and EPA notifies 

Respondent under Paragraph IV.8. that the SEP has not been satisfactorily completed because 

the cessation is contrary to the provisions of the SEP or of this Consent Agreement, Respondent 

shall pay a stipulated penalty equal to the amount of the SEP as specified in Paragraph IV.1., and 

any penalties owing under Paragraph VII.4., below, as of the day Respondent ceased work. 

18
 
1 4. If Respondent fails to comply with the terms of this Consent Agreement or its 

2 Appendices and the failure is not excused under the provisions of this Consent Agreement or its 

3 Appendices, Respondent shall pay stipulated penalties as follows: 

4 Violation Stipulated Penalty 

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a. Failure to pay the civil penalty specified in 

Paragraph III.3. above. 

$5,000 per day 

b. Failure to timely submit, modify, or implement, as 

approved, reports (including SEP Completion 

Reports), studies, analyses, protocols, or other 

submittals required in this Consent Agreement or its 

Appendices. 

$1,000 per day per violation during 

the first thirty (30) days, $2,500 per 

day per violation thereafter 

c. Any other violation of this Consent Agreement or 

its Appendices. 

$1,000 per day per violation 

14 5. All stipulated penalties shall begin to accrue on the day after the performance is due or 

15 on the day a violation occurs, whichever is applicable, and shall continue until performance is 

16 satisfactorily completed or until the violation ceases, whichever is applicable. Nothing in this 

17 Consent Agreement shall prevent the simultaneous accrual of separate stipulated penalties for 

18 separate violations of this Consent Agreement. 

19 6. EPA may, in its unreviewable discretion, waive payment of any portion of stipulated 

20 penalties that may accrue under this Consent Agreement. 

21 7. All stipulated penalties are due and owing, upon written demand by EPA, no later 

22 than sixty (60) days after Respondent receives such demand. 

23 8. All stipulated penalties shall be paid in a manner set forth in Paragraph III.3. 

24 9. In any action concerning EPA’s assessment of a stipulated penalty under this Consent 

25 Agreement, EPA shall be entitled to judgment for the claimed penalty amount unless Respondent 

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demonstrates, and the court finds, that EPA acted arbitrarily or capriciously in its determining 

that stipulated penalties should be assessed against Respondent. 

VIII. EPA ACCEPTANCE OF SEP COMPLETION REPORT 

1. Within sixty (60) days after receipt of each SEP Completion Report described in 

Section V.1., above, EPA shall notify the Respondent, in writing, that: a) the SEP Completion 

Report does not comply with Paragraph IV.6. in which case Respondent shall have an 

opportunity in accordance with Paragraph VIII.2., unless the parties agree to additional time, for 

Respondent to correct the deficiencies; or b) the SEP Completion Report complies with 

Paragraph IV.6. and the project has been completed satisfactorily; or c) the SEP Completion 

Report complies with Paragraph IV.6. but the SEP has not been satisfactorily completed and 

stipulated penalties may be assessed. Before EPA assesses stipulated penalties, Respondent may 

invoke the procedure in Paragraph IV.8. 

2. If EPA notifies Respondent that a SEP Completion Report does not comply with 

Paragraph IV.6 but EPA has not yet made a final determination about whether that particular 

SEP has been satisfactorily completed, Respondent shall have ten (10) business days following 

receipt of such notice to object to the Agency’s determination. Respondent’s objection must be 

in writing and submitted to the person in Paragraph V.1. EPA and Respondent shall have an 

additional thirty (30) days from the receipt by EPA of Respondent’s objection to reach 

agreement on changes necessary to the SEP Completion Report. If agreement cannot be reached 

on any such issue within this thirty (30) day period, EPA shall provide a written statement of its 

decision to Respondent, which decision shall be final and binding upon Respondent. 

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3. In the event the SEP Completion Report does not comply with Paragraph IV.6. and 

the parties have completed the procedure in Paragraphs VIII.1. and VIII.2., EPA may assess 

stipulated penalties against Respondent in accordance with Paragraph VII.4.b. 

IX. OTHER MATTERS 

1. Respondent may request, and EPA may grant, an extension of time for any action 

required of Respondent under this Consent Agreement. 

2. Payment Provisions: Pursuant to 31 U.S.C. § 3717, EPA is entitled to assess interest 

and penalties on debts owed to the United States and a charge to cover the cost of processing and 

handling a delinquent claim. Interest will therefore begin to accrue on a civil or stipulated 

penalty if it is not paid by the last date required. Interest will be assessed at the rate of the 

United States Treasury tax and loan rate in accordance with 4 C.F.R. § 102.13(c). A charge will 

be assessed to cover the costs of debt collection, including processing and handling costs and 

attorneys fees. In addition, a non-payment penalty charge of six (6) percent per year 

compounded annually will be assessed on any portion of the debt which remains delinquent 

more than ninety (90) days after payment is due. Any such non-payment penalty charge on the 

debt will accrue from the date the penalty payment becomes due and is not paid. 4 C.F.R. §§ 

102.13(d) and (e). 

3. Nothing in this agreement shall be construed as prohibiting, altering or in any way 

limiting the ability of EPA to seek any other monetary or non-monetary remedies or sanctions to 

which EPA is legally entitled, including but not limited to injunctive relief or an action to collect 

stipulated penalties, for Respondent's violation of: 1) any provision of law not resolved by the 

settlement of claims for civil penalties pursuant to TSCA and RCRA as alleged in the 

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Consolidated Action and the violations alleged in Section II, above, or 2) any applicable 

requirement under this Consent Agreement or its Appendices except that EPA will not seek to 

compel performance of a requirement in Appendices A or B. 

4. This Consent Agreement and Final Order shall not relieve Respondent of its 

obligation to comply with all applicable provisions of federal, state or local law, nor shall it be 

construed to be a ruling on, or determination of, any issue related to any federal, state or local 

permit. 

5. Force Majeure: 

a. If any event occurs which causes or may cause delays in complying with this 

Consent Agreement or its Appendices, Respondent shall notify Complainant in writing not more 

than ten (10) days after the delay or Respondent's knowledge of the anticipated delay, whichever 

is earlier, to the person in Paragraph V.1.a., above. The notice shall describe in detail the 

anticipated length of the delay, the precise cause or causes of the delay, the measures taken and 

to be taken by Respondent to prevent or minimize the delay, and the timetable by which those 

measures will be implemented. The Respondent shall adopt all reasonable measures to avoid or 

minimize any such delay. Failure by Respondent to comply with the notice requirements of this 

Paragraph shall render this Paragraph void and of no effect as to the particular incident involved 

and constitute a waiver of the Respondent's right to request an extension of its obligation under 

this Consent Agreement or its Appendices based on such incident. 

b. If the parties agree that the delay or anticipated delay in complying with this 

Consent Agreement or its Appendices has been or will be caused by circumstances entirely 

beyond the control of Respondent, the time for performance hereunder may be extended for a 

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period no longer than the delay resulting from such circumstances. In such event, the parties 

shall agree to such extension of time, during which period Respondent shall not be deemed to be 

in violation of this Consent Agreement or its Appendices. 

c. In the event that EPA does not agree that a delay in complying with this 

Consent Agreement or its Appendices has been or will be caused by circumstances beyond the 

control of the Respondent, EPA will notify Respondent in writing of its decision and any delays 

in the completion of the affected SEP shall not be excused. 

d. The burden of proving that any delay is caused by circumstances entirely 

beyond the control of the Respondent shall rest with the Respondent. Increased costs or 

expenses associated with the implementation of actions called for by this Consent Agreement 

shall not, in any event, be a basis for changes in this Consent Agreement or extensions of time 

under section (b) of this Paragraph. Delay in achievement of one interim step shall not 

necessarily justify or excuse delay in achievement of subsequent steps; it is Respondent’s burden 

to establish that a delay in achievement of one interim step justifies or excuses delay in 

achievement of subsequent steps. 

6. For purposes of Federal taxes, Respondent indicates that it does not intend to deduct 

funds expended in the performance of the SEPs from the company’s income except to the extent 

and in the event that such costs exceed six million two hundred fifty thousand dollars, 

($6,250,000). 

7. This Consent Agreement and Final Order constitutes a final settlement by EPA of the 

claims for civil penalties pursuant to TSCA and RCRA as alleged in the Consolidated Action 

and in Section II, above. EPA covenants not to sue Respondent in any forum for civil penalties 

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pursuant to TSCA or RCRA for any allegations in the Consolidated Action or in Section II, 

above. Nothing in this Consent Agreement and Final Order is intended to, nor shall be construed 

to operate in any way, to resolve any criminal liability of the Respondent. Except for the claims 

settled in this Consent Agreement and Final Order, compliance with this Consent Agreement and 

Final Order shall not be a defense to any actions subsequently commenced pursuant to Federal 

laws and regulations administered by EPA, and it is the responsibility of Respondent to comply 

with such laws and regulations. 

8. Each undersigned representative of the parties to this Consent Agreement certifies 

that he or she is fully authorized by the party represented to enter into the terms and conditions 

of this Consent Agreement and to execute and legally bind that party to it. 

9. Respondent’s obligations under this Consent Agreement and its Appendices shall 

terminate upon Respondent: 

a) paying the civil penalty specified in Paragraph III.3., above, and either 

b) satisfactorily completing all SEPs and paying any stipulated penalty due under 

Paragraph VII.4. or,

 c) paying stipulated penalties under Paragraphs VII.1-3. 

Within thirty (30) days of termination of Respondent’s obligations of this Consent Agreement 

and its Appendices in accordance with this Paragraph, the parties shall file a notice of 

termination thereof with the Headquarters Hearing Clerk. 

10. The effect of settlement described in Section IX.7., of this Consent Agreement and 

Final Order is conditional upon the accuracy of the Respondent’s representations to EPA that 

EPA relied upon in settling this matter. 

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1 BEFORE THE ADMINISTRATOR
 

2 UNITED STATES
 

3 ENVIRONMENTAL PROTECTION AGENCY
 

4
 

6 IN THE MATTER OF: ) 

7 ) 

8 ) 

9 E. I. du Pont de Nemours ) Docket No. TSCA-HQ-2004-0016 

 and Company ) Docket No. RCRA-HQ-2004-0016 

11 ) Docket No. TSCA-HQ-2005-5001 

12 Wilmington, DE ) 

13 ) 

14 ) 

Respondent ) 

16 ) 

17 Washington Works Facility ) 

18 Route 892 South DuPont Road ) 

19 Washington, Wood County, WV ) 

) 

21

22 FINAL ORDER 

23 Pursuant to Section 16 of the Toxic Substances Control Act (“TSCA”), 15 U.S.C. §§ 

24 2601 et seq., and Section 3008 of the Resource Conservation and Recovery Act (“RCRA”), as 

amended by the Hazardous and Solid Waste Amendments (“HSWA”), 42 U.S.C. §§ 6901 et seq., 

26 it is hereby ORDERED THAT: 

27 1. Respondent shall comply with all of the terms of the Consent Agreement, incorporated 

28 herein by reference, including the terms of the Consent Agreement relating to performance of the 

29 SEPs attached to and incorporated in the Consent Agreement; 

2. Nothing in the Consent Agreement relieves Respondent from complying with the 

31 requirements set forth in TSCA and RCRA and the regulations thereunder; 

32 3. Respondent is assessed a civil penalty in the sum of (Ten Million Two Hundred Fifty 

33 Thousand Dollars ($10,250,000); 

34	 4. Respondent shall, within thirty (30) days of the effective date of this Order, forward a 

certified or cashier's check, payable to the order of the "Treasurer of the United States of 

36 America", in the amount of $ 10,250,000 to: 

37 EPA-Washington 

38 (Hearing Clerk) 

39 Docket No. Docket No. TSCA-HQ-2004-0016, RCRA-HQ-2004-0016, 

TSCA-HQ-2005-5001 

41 P.O. Box 360277 

42 Pittsburgh, PA 15251-6277 
1 or an electronic payment of $ 10,250,000 by wire transfer as instructed in this agreement. 

2 The check or wire transfer shall bear the notation “DuPont, Civil Penalty Docket Nos. TSCA3 HQ-2004-0016, RCRA-HQ-2004-0016, TSCA-HQ-2005-5001.” 

4 5. Failure to remit the civil penalty in Paragraph 3, above, in accordance with this Order 

5 will constitute a breach of this Order and will cause Respondent to become subject to the 

6 stipulated penalty of five thousand dollars ($5,000) per diem immediately, plus interest as 

7 allowed by law, and without further proceedings. 

8 IT IS SO ORDERED. 

9

10 Environmental Appeals Board 

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13 Date__________ Environmental Appeals Judge 

14 U.S. Environmental Protection Agency 

15

2
 
1 APPENDIX A 

2 TO CONSENT AGREEMENT AND FINAL ORDER 

3 FLUOROTELOMER-BASED PRODUCT BIODEGRADATION TESTING 

4 SUPPLEMENTAL ENVIRONMENTAL PROJECT 

5 I. OVERVIEW OF FLUOROTELOMER-BASED POLYMER PRODUCT 

6 BIODEGRADATION TESTING SUPPLEMENTAL ENVIRONMENTAL PROJECT 

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

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

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

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

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

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

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

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

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

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

17 the requirements of this Appendix and Attachments A-G. 

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

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

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

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

22 the Fluorotelomer Products with respect to the chemical composition that creates their 

23 fluorotelomer functionality (“Corresponding Polymers”). Eight of the nine Fluorotelomer 

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Products to be tested under this Biodegradation SEP are fluorotelomer-based polymers, while the 

ninth is a fluorotelomer-based phosphate ester. The Fluorotelomer Products are products that 

were sold by DuPont prior to the date DuPont signs the Consent Agreement, and that DuPont 

will provide as the chemical substances to be tested pursuant to this Biodegradation SEP. An 

understanding of the degradation potential of the Fluorotelomer Products will be developed by 

considering the results of both OECD Guideline 303A and semi-continuous activated sludge 

(SCAS) studies. Accordingly, this Biodegradation SEP is designed to: (1) provide information 

regarding the behavior of the Fluorotelomer Products and their Corresponding Polymers in 

activated sludge biological wastewater treatment systems using a simulated sewage treatment 

plant test (OECD Guideline 303A), and (2) provide information on the inherent biodegradation 

potential of the Fluorotelomer Products and their Corresponding Polymers using SCAS. 

a. The OECD Guideline 303A study is a sewage treatment plant (“STP”) 

simulation in activated sludge used to generate data concerning the fate of a test substance 

during biological treatment, using laboratory-scale aerobic STP. Conditions are controlled to 

simulate the operating conditions of a wastewater treatment plant. The study is designed to 

determine the elimination of the test substance by aerobic microorganisms in a continuously 

operated test system simulating the activated sludge process. Naturally occurring carbon in the 

sewage feed and the test substance are the sources of carbon and energy for the microorganisms. 

The study investigates the distribution of the test substance and its degradation product(s) 

between the different phases in the test system: aqueous, biomass (activated sludge), and 

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

are indicative of degradation by determining the amount and rate of formation of observed 

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degradation product(s) in the aqueous, sludge, and gas phases. Performing OECD Guideline 

303A on the Fluorotelomer Products and then comparing the results to the same study performed 

on their Corresponding Polymers will enable a close look at the potential performance of each of 

the Fluorotelomer Products and their Corresponding Polymers in a sewage treatment plant 

simulation. 

b. The modified SCAS test is an inherent biodegradability study in which 

the test substance is exposed to activated sludge microorganisms in an aerated, aqueous medium 

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

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

are indicative of degradation by determining the amount and rate of formation of observed 

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

Fluorotelomer Products and then comparing the results to the same study performed on their 

Corresponding Polymers will enable a close look at the potential aerobic biodegradation of each 

of the Fluorotelomer Products. The test also gives an indication of the potential for removal of 

the test substances via sorption to the activated sludge inoculum. 

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

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

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

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

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

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

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

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

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

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

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

example, fluorotelomer acrylate monomers [F-(CF2-CF2)n-CH2-CH2-O-C(O)-CH=CH2, n = 

3,4,5 commonly] are copolymerized with one or more of a group of hydrocarbon monomers to 

create an acrylic polymer with fluorotelomer functionality. The most common fluorotelomer 

raw material used in DuPont’s fluorotelomer products is the family of fluorotelomer alcohols. 

These alcohols are generally further transformed into polymeric and non-polymeric 

fluorotelomer-based products. This Biodegradation SEP involves the testing of polymeric and 

non-polymeric fluorotelomer products based on these common fluorotelomer intermediates; any 

reference in this Biodegradation SEP to DuPont’s commercial Fluorotelomer Products and their 

Corresponding Polymers is a reference to both the polymeric and non-polymeric products. 

DuPont generally manufactures product concentrates as aqueous dispersions of 

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

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

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

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

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

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

the purpose of attempting to assess the biodegradation potential of cured fluorotelomer-based 

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polymer products would need to be carefully done given the differences between the cured and 

uncured fluorotelomer-based products. Substances made with fluorotelomer functionality should 

not be referred to as either “perfluorinated” or “fluoropolymers” as these terms describe other 

materials. 

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

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

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

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

“Corresponding Polymers”). 

a. A purified polymer for each of the Fluorotelomer Products listed in 

Attachment A that has been isolated from the Fluorotelomer Product and redispersed (“Purified 

Fluorotelomer Product”). On or before February 1, 2006, DuPont and EPA will agree on the 

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

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

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

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

Products to the laboratories for characterization, testing and studies, and the overall schedule for 

completing this Biodegradation SEP. Within seven (7) business days of producing each Purified 

Fluorotelomer Product, DuPont shall provide EPA with the procedure(s) used to produce such 

Purified Fluorotelomer Product and the purity level achieved for such Purified Fluorotelomer 

Product. 

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b. A synthesized fluorotelomer product containing a purified polymer, 

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

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

c. A synthesized fluorotelomer product containing a purified polymer, 

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

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

3. Timing of Test Substance Transfer. 

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

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

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

Fluorotelomer Products to such laboratories. 

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

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

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

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

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

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

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

each laboratory’s EPA-approved work plan. 

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

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

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

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

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

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

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

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

molecular weight distribution of polymeric material in the Fluorotelomer Products and 

Corresponding Polymers. 

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

Party Laboratory (“laboratory”) to: 

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

identified in Attachment A, following study guidelines for OECD Guideline 303A (aerobic 

sewage treatment for activated sludge units) and modified semi-continuous activated sludge 

(SCAS). 

b. Perform OECD Guideline 303A and SCAS studies on the 

Fluorotelomer Products and any Corresponding Polymers selected by EPA to be used in the 

biodegradation studies. 

c. The laboratory will conduct these biodegradation studies on the 

Fluorotelomer Products and any of their Corresponding Polymers in order to investigate the 

degradation potential of these Fluorotelomer Products to produce perfluorooctanoic acid (PFOA) 

or other analytes identified in Attachment C, and to determine the potential, if any, for their 

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

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

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

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

be involved in this Biodegradation SEP at specified milestones. 

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

the inherent biodegradation potential of the Fluorotelomer Products and their Corresponding 

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

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

address the biodegradation potential of the Fluorotelomer Products or their Corresponding 

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

degradation under anaerobic conditions. Additionally, using the results of this Biodegradation 

SEP to attempt to assess the biodegradation potential of cured polymers would need to be 

carefully done given the differences between cured and uncured fluorotelomer-based products. 

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

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

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

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

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

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

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

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

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

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

chemical, formation and identification of degradation products, partitioning of these chemicals to 

sludge solids, and volatilization under conditions controlled to mimic those found in full-scale 

aerobic wastewater treatment systems. The results from these studies are indicative of how the 

test substance will behave in full-scale systems. 

II. GENERAL OBLIGATIONS AND REQUIREMENTS 

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

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

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

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

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

meaning of Section IV.4 of the CAFO, no later than three (3) years from the date DuPont 

receives the signed Final Order of the Environmental Appeals Board approving the Consent 

Agreement (“SEP Completion Date”). No later than sixty (60) days prior to the SEP Completion 

Date, if DuPont believes that it will be unable to satisfactorily complete the SEP within such 

three-year period, DuPont shall petition EPA to extend the SEP Completion Date based upon 

DuPont’s assertion of good cause to extend such date. The Office of Civil Enforcement, in 

consultation with the Office of Pollution Prevention and Toxics, will review DuPont's petition 

and meet with DuPont to discuss its petition. The Office of Civil Enforcement, in consultation 

with the Office of Pollution Prevention and Toxics, shall determine whether DuPont has 

demonstrated that there is good cause to extend the SEP Completion Date and, if determining 

that DuPont has demonstrated good cause, determine how long to extend the SEP Completion 

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Date. 

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

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

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

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

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

the point of contact for EPA and the laboratories. 

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

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

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

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

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

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

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

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

biodegradation studies. Each Fluorotelomer Product and Purified Fluorotelomer Product that 

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

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

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

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

provided to the laboratory performing biodegradation testing. 

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

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

the characterization and biodegradation studies (i.e., OECD Guideline 303A and SCAS tests 

(including pilots)) performed under this Biodegradation SEP. DuPont shall fulfill this obligation 

by providing these sufficient quantities of the Fluorotelomer Products and Corresponding 

Polymers to the laboratory performing characterization. In dividing the samples that it receives 

from DuPont for transfer to EPA, such laboratory shall not divide the quantity of each test 

substance that it receives from DuPont evenly but rather, shall divide each test substance in a 

sufficient amount for the laboratory to also perform characterization and then shall provide the 

larger remainder of each divided sample to EPA following the chain of custody procedures in 

Attachment D. DuPont and the laboratory performing characterization shall develop 

appropriate holding procedures for the test substances to assure the chemical integrity of such 

substances. These appropriate holding procedures shall be provided to EPA seven (7) days in 

advance of the date that the laboratory provides the divided samples to EPA. 

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

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

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

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

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

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

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

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

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relating to performance of this Biodegradation SEP. 

1. In providing comments to DuPont regarding such documents or submissions, 

EPA will include justification(s) and/or rationale(s) for the comments. EPA will provide such 

comments to DuPont within a reasonable amount of time, commensurate with the type and 

nature of the document or submission being reviewed. 

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

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

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

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

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

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

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

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

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

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

require DuPont to modify or remove from any such contract or agreement any provision that 

requires the contractor to indemnify DuPont for stipulated penalties that DuPont pays under 

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

with a schedule to which the contractor has agreed. 

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

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

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

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

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

by DuPont, a laboratory, or the Panel Administrator to EPA shall be submitted via first class 

mail, return receipt requested, or by commercial delivery service with documented delivery, to 

the person identified in Section V of the CAFO. All submissions shall be provided in electronic 

format on a compact disc (CD). All submissions shall be accompanied by a cover letter in 

hardcopy, that describes the contents of the CD, and complies with any other requirements of the 

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

above, where to transfer such divided samples. 

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

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

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

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

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

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

of the sanitized version. 

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

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

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

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

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

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

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Polymers that EPA selects for biodegradation studies, in accordance with Attachment B. 

2. DuPont shall use one laboratory to perform OECD Guideline 303A and SCAS 

studies (referred collectively herein as the “biodegradation studies”), in accordance with 

Attachment C. 

a. This laboratory shall perform the OECD Guideline 303A and SCAS 

studies concurrently on the Fluorotelomer Products and any Corresponding Polymers that EPA 

selects for biodegradation studies, following both the sequence, and grouping (to maximize 

laboratory efficiency, capacity allowing) provided in Attachment A. 

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

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

identified in Attachment G appears to be reasonably capable of, or if no laboratory is willing to 

contractually commit to, completing all of the biodegradation studies (including pilots) by no 

later than twenty-seven (27) months after receipt of the Fluorotelomer Products and any 

Corresponding Polymers (or such longer time as EPA approves), the parties agree to implement 

the following approach, in the following order of preference: 

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

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

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

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

subcontractor for the analytical component of the biodegradation studies; or 

ii. DuPont shall propose two laboratories identified in Attachment 

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

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work between the two laboratories, subject to EPA approval. 

3. Pilot Testing 

a. The laboratory performing the biodegradation studies shall conduct one 

14-day pilot test for OECD Guideline 303A and one 14-day pilot test for SCAS on each of the 

Fluorotelomer Products that have been selected for pilot testing as identified in Attachment A, 

and shall conduct one 14-day pilot test for OECD Guideline 303A and one 14-day pilot test for 

SCAS on each of the Corresponding Polymers that have been selected for pilot testing as 

identified in Attachment A, to develop test data that can inform protocol decisions and to 

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

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

Corresponding Polymers. 

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

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

Corresponding Polymers for the pilot tests in the remaining groups. 

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

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

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

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

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

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

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

comments that DuPont has submitted to EPA pursuant to Section II.K, below. EPA will then 

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transmit its comments and judgments to DuPont and require DuPont to direct the laboratory to 

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

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

and judgments. The laboratory shall not commence the biodegradation studies until it has 

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

Corresponding Polymers shall be used in the biodegradation studies. 

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

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

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

addressing the charge set forth in Section V.A.2.b. To be eligible for consideration by EPA, 

DuPont must submit such comments to EPA within seven (7) business days of DuPont’s receipt 

of the technical document. EPA reserves the right to directly seek input from the appropriate 

laboratory regarding DuPont’s comments. The extension of deadlines in Section II.L, below, 

does not apply to this Section II.K. A request for an extension of this deadline shall be subject to 

EPA’s discretion, and granted for good cause shown. 

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L. Extensions of deadlines other than the SEP Completion Date 

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

in a work plan or other submission implementing this Biodegradation SEP, other than the SEP 

Completion Date, DuPont shall be entitled to a first extension as a matter of right, provided that 

DuPont submits a written notice to EPA that it is exercising this provision, no later than one 

business day prior to the deadline. 

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

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

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

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

thirty (30) days, for good cause shown. 

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

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

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

for good cause shown. 

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

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

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

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

granted provided that DuPont’s Study Monitor sent a written notice to the third party no later 

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

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

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

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

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

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

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

days, for good cause shown. 

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

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

that does not involve work that DuPont has contracted with a third party to perform, or (b) a 

third request for an extension of a deadline that does involve work that DuPont has contracted 

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

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

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

of time different from the amount of time requested by DuPont. 

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

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

of EPA’s review and approval of a submission that DuPont provided to EPA sufficiently in 

advance of the deadline so as to allow EPA a reasonable amount of time to review and approve 

the submission, commensurate with the type and nature of the submission, DuPont will be 

entitled to an extension to perform the required action. The extension shall be equal to the 

number of days of EPA’s review and approval of the submission and shall be calculated from the 

date that EPA received such submission through the date that EPA transmitted its approval of the 

submission to DuPont. If, during its review and prior to its approval, EPA requests that DuPont 

make changes to the submission, in calculating the extension, the parties shall not include the 

amount of time for DuPont to make such changes and resubmit the document to EPA for 

approval. Such time excluded from the extension shall start from the date that EPA transmits the 

requested changes to DuPont through the date that EPA receives the amended submission, 

incorporating the requested changes. But, such time excluded from the extension shall not 

include time during which EPA is still reviewing a portion of the submission for which EPA has 

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

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

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

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

extension of deadlines. 

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III. SELECTION OF THIRD PARTY LABORATORIES 

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

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

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

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

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

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

established in this Appendix. 

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

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

identified in Attachment G to solicit proposals for (1) characterizing the Fluorotelomer Products 

and any Corresponding Polymers, and (2) conducting the OECD Guideline 303A and SCAS 

studies on the Fluorotelomer Products and any Corresponding Polymers (including pilot testing). 

The proposed RFPs must at least include the following elements: 

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

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

of this Appendix. 

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

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

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

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

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

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extent feasible, a firm cost estimate for the work. 

a. Laboratories receiving the RFP for characterization of the 

Fluorotelomer Products and Corresponding Polymers must provide cost estimates for 

characterizing all of the Fluorotelomer Products and their Corresponding Polymers. 

b. Laboratories receiving the RFP for the biodegradation work must 

include cost estimates for conducting 14-day pilot tests for OECD Guideline 303A and 14-day 

pilot tests for SCAS on the Fluorotelomer Products and the Corresponding Polymers, as 

identified in Attachment A, and for performing OECD Guideline 303A and SCAS studies on all 

Fluorotelomer Products and their Corresponding Polymers. 

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

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

the required analytical work associated with the characterization or biodegradation studies 

required under this Biodegradation SEP. 

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

shall provide the guidelines for OECD Guideline 303A and SCAS, included in Attachment C of 

this Appendix. 

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

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

deadlines and criteria set forth in this Appendix. 

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

Section III.F.2, below. 

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

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

ineligible for selection. 

C. Within seven (7) days of receipt of the approved RFP, DuPont shall provide the EPAapproved RFPs to all laboratories listed in Attachment G that have submitted to DuPont a signed 

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

laboratory by the date that DuPont is required to provide the RFP, DuPont shall notify EPA why 

it cannot send the RFP to such laboratory. EPA reserves the right to contact such laboratory to 

inquire why it has not returned the confidentiality agreement and, if such laboratory agrees 

within seven (7) business days of contact by EPA to sign and submit the confidentiality 

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

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

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

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

to be eligible to perform work under this Biodegradation SEP. 

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

to EPA concurrent with its submission to DuPont. 

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

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

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

submit a proposal, the laboratory must do so by a date to be specified by EPA, which shall not be 

longer than fourteen (14) days after contact by EPA, unless the parties agree to a longer time 

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period. 

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

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

propose to EPA the laboratory that DuPont would like to use to perform the characterization of 

the Fluorotelomer Products and Corresponding Polymers, and the laboratory that DuPont would 

like to use to perform the biodegradation studies of the Fluorotelomer Products and 

Corresponding Polymers. 

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

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

laboratories that submitted a proposal to perform such work. 

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

SCAS and OECD Guideline 303A studies on the Fluorotelomer Products and Corresponding 

Polymers. DuPont shall contract with only one laboratory to characterize the Fluorotelomer 

Products and Corresponding Polymers. 

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

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

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

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

to DuPont’s laboratory selection. 

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

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

of Pollution Prevention and Toxics shall meet with DuPont to discuss appropriate changes that 

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can be made to this Biodegradation SEP to foster laboratory participation in the performance of 

this Biodegradation SEP. EPA and DuPont shall first implement the alternative approach set 

forth in Section II.J.2.b before EPA considers whether to expand the list of potential laboratories 

identified in Attachment G to include foreign laboratories. If the parties cannot agree to any 

such appropriate changes, or if after agreeing to such appropriate changes, no laboratories submit 

a proposal, this Biodegradation SEP shall be deemed to have ceased prior to its completion, in 

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

subject to Section VII.1 of the CAFO, and the parties may exercise Section VI of the CAFO even 

though this Biodegradation SEP is not deemed satisfactorily completed. 

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

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

contract that DuPont and the two laboratories have negotiated. 

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

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

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

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

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

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

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

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

from EPA for written information from a laboratory pertaining to work it is performing under 

this Biodegradation SEP will be transmitted through DuPont’s designated Study Monitor. 

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DuPont’s Study Monitor shall notify the laboratory of EPA’s request for such information within 

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

EPA and DuPont within three (3) business days of DuPont’s Study Monitor’s notice to the 

laboratory. 

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

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

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

instruct the laboratory to implement the change immediately and continue running the test. 

DuPont may submit comments for EPA’s consideration regarding such modification, in 

accordance with Section II.K, above. 

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

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

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

DuPont of the modification and require DuPont to instruct the laboratory to provide EPA and 

DuPont with all data generated up to that date and immediately terminate the test and re-run the 

test implementing the modification. DuPont may submit comments for EPA’s consideration 

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

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

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

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

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

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

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d. Material Modifications. Any proposed material modification that a 

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

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

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

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

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

Biodegradation SEP. 

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

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

work previously approved by EPA under this Biodegradation SEP, except as provided in Section 

III.F.2.f, below. If, based upon this notification, EPA believes that such modification is material, 

EPA will orally notify DuPont and the laboratory immediately, and require DuPont to instruct 

the laboratory to submit such proposed modification to EPA for approval within the timeframe 

that EPA establishes in the oral notice. DuPont may submit comments for EPA’s consideration 

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

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

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

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

adverse affect on the test if not immediately implemented. The laboratory shall provide notice to 

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

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

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

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

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

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

additional change, in accordance with Section II.K, above. 

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

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

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

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

to that date, and costs incurred. 

h. Information Exchange. When the laboratory provides any information 

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

SEP, the laboratory shall provide such information to the other party as soon as practicable. The 

laboratory is not responsible for disseminating information that it receives in written form from 

DuPont; DuPont shall concurrently provide the information to EPA. When the laboratory 

provides information in oral form to EPA or DuPont concerning the laboratory’s work under this 

Biodegradation SEP, the laboratory shall communicate such information to the other party as 

soon as practicable. The laboratory is not responsible for communicating information it receives 

in oral form from DuPont or EPA; each party shall communicate such information to the other 

party. However, when the laboratory receives an oral communication from DuPont or EPA, it 

shall notify both parties and provide a brief written description of such oral communication. To 

the extent practicable, the parties shall jointly communicate orally with the laboratory in light of 

the laboratory’s obligation to prepare a written notification to the parties when it receives an oral 

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communication, not jointly, from either party. 

i. The laboratory shall allow Peer Consultation Panel members to visit the 

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

relevant to the work that the laboratory is performing under this Biodegradation SEP. 

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

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

forward the contract to the laboratory for execution. 

a. DuPont and the laboratory shall seek to execute the contract within thirty (30) 

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

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

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

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

exercising its right to an automatic extension in Section II.L, but before a second request for an 

extension under Section II.L, if DuPont believes that, notwithstanding its best efforts, the 

laboratory will not enter into the contract with DuPont, DuPont shall provide notice to EPA of 

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

DuPont, to inquire why the laboratory has not entered into the contract with DuPont. If DuPont 

and the laboratory have not entered into a contract within fourteen (14) days EPA’s inquiry, 

unless DuPont and EPA agree to a longer time period, then the parties shall follow the approach 

set forth in Section III.H, below. 

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

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

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1 laboratory. 

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

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

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

5 participation in the performance of this Biodegradation SEP. If the parties cannot agree to any 

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

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

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

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

10 CAFO even though this Biodegradation SEP is not deemed satisfactorily completed. 

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

12 laboratory execute the contract, the laboratory must commence the work it has agreed to perform 

13 under the contract, as described in Section IV, below. 

14 IV. TESTS TO BE PERFORMED ON DUPONT’S FLUOROTELOMER PRODUCTS AND 

15 CORRESPONDING POLYMERS 

16 A. Characterization of the Fluorotelomer Products and Corresponding Polymers 

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

18 in this Section IV.A, within thirty (30) days from the date that DuPont and the laboratory execute 

19 the contract to perform work under this Biodegradation SEP. The laboratory shall commence 

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

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

22 (including Attachment B), and a general schedule and budget for completion of the work. 

23 Within forty-five (45) days from the date that DuPont and the laboratory execute the contract to 

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

technical documents that require EPA’s approval. 

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

relevant technical documents, the laboratory shall begin the implementation of the EPAapproved work plan. 

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

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

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

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

with the first Certificate of Analysis but need not provide the QAPP for the remaining eight 

Fluorotelomer Products and Corresponding Polymers. 

B. Biodegradation Studies: OECD Guideline 303A and SCAS 

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

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

the contract to perform such work. The laboratory shall commence such work by submitting a 

work plan to EPA that describes the work the laboratory has been contracted to perform, 

addressing all requirements for such work under this Biodegradation SEP (including Attachment 

C), and a general schedule and budget for completion of the work. Within ninety (90) days from 

the date that DuPont and the laboratory execute the contract to perform work under this 

Biodegradation SEP, the laboratory shall submit to EPA all relevant technical documents that 

require EPA’s approval. 

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

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relevant technical documents, the laboratory shall begin the implementation of the EPAapproved work plan. 

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

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

plant operating in compliance with its National Pollutant Elimination Discharge System 

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

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

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

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

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

EPA will notify DuPont to instruct the laboratory of a change in the sampling schedule and 

establish a new timeframe for sampling. Analyses shall be conducted using the most accurate 

instrumentation and procedures available as of the time of testing. All analytical methods shall 

be approved by EPA prior to the start of the studies. 

b. The laboratory shall run the OECD Guideline 303A test for twelve (12) 

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

wastewater treatment plant operating in compliance with its NPDES permit. Settled domestic 

sewage from a municipal wastewater treatment plant operating in compliance with its NPDES 

permit shall be used as feed. Daily samples of the aqueous phase, sludge solids, and off gas shall 

be collected, analyzed, and quantified for the analytes listed in Attachment C of this 

Biodegradation SEP. If at any time EPA determines, or if DuPont or the laboratory recommends 

and EPA determines, that daily sampling is not necessary, EPA will notify DuPont to instruct the 

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laboratory of a change in the sampling schedule and establish a new timeframe for sampling. 

Analyses shall be conducted using the most accurate instrumentation and procedures available as 

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

testing. 

3. The laboratory shall conduct one 14-day pilot test for OECD Guideline 303A 

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

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

for OECD Guideline 303A and one 14-day pilot test for SCAS on each of the Corresponding 

Polymers that have been selected for pilot testing as identified in Attachment A, to develop test 

data that can inform protocol decisions and to establish that these biodegradation studies can 

produce results that can be analyzed and quantified with regard to the biodegradation potential of 

the Fluorotelomer Products and Corresponding Polymers. 

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

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

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

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

the protocols, and a copy of the raw data. 

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

and protocols for the OECD Guideline 303A and SCAS studies, the laboratory shall begin the 

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

Attachment A. 

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

for purposes of the biodegradation studies. 

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

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

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

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

any, shall be used in the biodegradation studies. 

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

completing the biodegradation studies on the first Fluorotelomer Product and any of its 

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

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

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

Consultation Panel. 

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

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

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

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

b. As the laboratory completes biodegradation studies on each 

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

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

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

Administrator for distribution to the Peer Consultation Panel. 

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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 with 

6 DuPont. 

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

8 FLUOROTELOMER PRODUCTS AND CORRESPONDING POLYMERS 

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

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

11 administer the Peer Consultation process under this Biodegradation SEP. 

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

13 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 Administrator 

18 shall develop a pool of potential Panel members that will be subject to comment by EPA, 

19 DuPont, and the public. 

20 c. After considering all comments received regarding the Panel member 

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

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

23 Panel. If both parties, independently, recommend to the Panel Administrator that a particular 

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

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

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

and DuPont for comment. The Panel Administrator shall follow this approach until it has 

selected a final Panel. 

d. The Panel Administrator shall treat all comments received under 

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

2. The Panel is charged to: 

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

characterize the Fluorotelomer Products and Corresponding Polymers for chemical 

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

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

i. whether the approved or accepted protocols were sufficiently 

robust to provide reliable characterization data, and 

ii. whether the laboratory correctly followed the protocols. 

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

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

developing a final design and protocol for the OECD Guideline 303A and SCAS studies that will 

be approved by EPA prior to implementation by the laboratory. 

c. Compare the pilot results and characterization data of each 

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

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

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

should be used in the biodegradation studies. 

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

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

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

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

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

Corresponding Polymer for each Fluorotelomer Product but can identify two Corresponding 

Polymers for a particular Fluorotelomer Product, the Panel shall so state, and provide a detailed 

explanation as to why it is appropriate to use the two Corresponding Polymers in the 

biodegradation studies. 

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

Corresponding Polymers for each Fluorotelomer Product and recommends that all three 

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

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

use all three Corresponding Polymers in the biodegradation studies. 

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

Corresponding Polymers for a Fluorotelomer Product and recommends that no Corresponding 

Polymer be used in the biodegradation studies, the Panel shall so state, and provide a detailed 

explanation as to why it is not appropriate to use any Corresponding Polymers in the 

biodegradation studies. 

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

should run a 14-day pilot test for OECD Guideline 303A and SCAS on each of the 

Corresponding Polymers that it recommends should be used in the biodegradation studies but 

which were not pilot tested by the laboratory performing the biodegradation work. 

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

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

e. Evaluate the results of the OECD Guideline 303A and SCAS studies 

performed on the fluorotelomer products and any corresponding purified fluorotelomer products, 

and advise EPA as to what the results mean, both for the individual substances and for the group 

of test substances as a whole. 

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

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

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

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

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

biodegradation studies. 

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

the Panel that relate to, and are consistent with, the purposes of this Biodegradation SEP. 

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

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

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

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

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

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

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

of the Panel to participate in providing advice on specific charges. Accordingly, at different 

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

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

the Panel Administrator to serve as members of this Peer Consultation Panel. While consensus is 

not required, an accurate summary of all opinions expressed by the individual members must be 

submitted to EPA. The Panel will not operate under a consensus-based process but rather should 

identify areas of agreement and disagreement, and provide supporting scientific rationale. While 

EPA will consider the advice and recommendations it receives from the Panel, EPA is not bound 

by such advice or recommendations. 

C. Qualifications and Requirements for Panel Members 

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

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

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

characterization of polymers and fluorochemicals. Specific knowledge of fluorotelomer 

chemistry is desirable. 

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

contributions to science-based evaluations. 

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

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

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

D. General Requirements for the Peer Consultation Process 

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

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

stated in Section V.C. 

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

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

comments to EPA regarding the conflict of interest guidelines. 

3. The Panel Administrator shall submit information to Administrative Record 

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

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

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

Confidential Business Information if submitted to EPA. 

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

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

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

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

confidentiality agreements, and prior approval from DuPont. 

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

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

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

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

regarding technical documents developed by the laboratories under consideration by the Peer 

Consultation Panel. The Panel Administrator shall not provide such written comments to Panel 

members in advance of any Panel meetings or deliberations but only provide such comments to 

the Panel members at the time of the Panel meetings or deliberations so as not to bias the Panel 

members’ premeeting consideration of any particular issue under consideration. 

E. Selection and Responsibilities of the Panel Administrator 

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

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

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

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

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

provisions. 

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

of the proposed contract, DuPont must sign and forward the contract to the Panel Administrator 

for execution. 

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

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

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

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

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

reason for the delay, provide a reasonable estimate as to when the contract will be executed, and 

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exercise its right to an automatic extension provided in Section II.L, above. However, if DuPont 

believes that, notwithstanding its best efforts, the candidate Panel Administrator will not execute 

the contract with DuPont, DuPont shall provide notice to EPA of the impasse. EPA reserves the 

right to contact such candidate Panel Administrator, upon receipt of such notice from DuPont, to 

inquire why it has not entered into the contract with DuPont. If DuPont and the candidate Panel 

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

unless EPA and DuPont agree to a longer time period, then the parties shall follow the approach 

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

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

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

with the Panel Administrator. 

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

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

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

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

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

changes, no potential Panel Administrators enters into a contract with DuPont, this 

Biodegradation SEP shall be deemed to have ceased prior to its completion, in which case, 

DuPont shall not be subject to Section VII.3 of the CAFO but DuPont shall be subject to Section 

VII.1 of the CAFO, and the parties may exercise Section VI of the CAFO even though this 

Biodegradation SEP is not deemed satisfactorily completed. 

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

execution, the Panel Administrator must submit to EPA a proposed work plan (including all 

applicable attachments) that addresses the following: 

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

the Peer Consultation process under this Biodegradation SEP from the date the Panel 

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

submits to EPA and AR226 the Panel’s final report from the last Panel meeting. 

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

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

how many experts to empanel to address the charges. 

c. The schedule for the Panel to timely address the charges in Section 

V.A.2 to ensure the most efficient use of the Panel. 

i. The Panel Administrator shall communicate with the laboratory 

performing the biodegradation testing to determine if it would be appropriate to have the Peer 

Consultation Panel review the results of the first pilot test for OECD Guideline 303A and SCAS 

and, once the laboratory has begun the full biodegradation studies, the results of the OECD 

Guideline 303A and SCAS studies for the first grouping of chemical substances identified in 

Attachment A, i.e., the three Fluorotelomer Products identified as the A group, and any 

Corresponding Polymers selected for testing, or any subsequent groupings identified in 

Attachment A, as appropriate. The Panel Administrator may seek a recommendation from the 

laboratory with regard to this issue and/or the Panel Administrator may make its own 

determination after reviewing the data as to whether it is appropriate to convene the Peer 

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Consultation Panel to review such results or to delay the review until all pilot tests and all 

biodegradation studies are completed. 

ii. Regardless of how Peer Consultation is handled with regard to 

reviewing the first pilot test results and biodegradation study results, all pilot tests and 

biodegradation studies shall be reviewed by the Peer Consultation Panel. 

d. The proposed conflict of interest guidelines that will be used to screen 

potential Panel members. The Panel Administrator shall send the conflict of interest guidelines 

to DuPont concurrent with its submission to EPA. DuPont shall have fourteen (14) business 

days to provide comments to EPA regarding such conflict of interest guidelines. 

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

honorarium to be paid to each Panel member. 

f. The proposed confidentially agreements for the Panel members. 

g. The process that the Panel Administrator will use to draft, on behalf of 

the Panel, the Panel’s reports. The Panel Administrator must address the following: 

i. The process and schedule for the Panel Administrator to 

compile comments from the Panel; and 

ii. The process and schedule for the Panel Administrator to submit 

a draft of the document to the Panel members for their review and comment before such 

document becomes final. 

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

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

deliberation at a laboratory located outside of North America, the Panel Administrator shall seek 

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prior approval from EPA before arranging such meeting. 

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

that are necessary to implement and administer the Peer Consultation process under this 

Biodegradation SEP. 

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

Administrator must commence the Peer Consultation process, as described in the EPA-approved 

work plan. 

7. The Panel Administrator is responsible for arranging Panel meetings and/or 

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

exchange of information to Panel members; submitting all Panel reports to EPA and DuPont, 

with a sanitized version concurrently submitted to AR 226; and for carrying out all other 

functions necessary to implement and administer the Peer Consultation process under this 

Biodegradation SEP. 

8. Information Exchange. When the Panel Administrator provides any 

information in oral or written form to EPA or DuPont concerning the Peer Consultation process, 

the Panel Administrator shall provide such information to the other party in the same form as 

soon as practicable. The Panel Administrator is not responsible for sharing information it 

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

Panel Administrator shall concurrently provide the information in the same form to the other 

party. However, when the Panel Administrator receives a substantive oral or written 

communication from DuPont or EPA that impacts the Panel Administrator’s implementation 

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

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communication and provide a brief written description of the content of the communication. 

9. Recommendations, Advice, and Conclusions of the Panel 

a. Final Panel Reports submitted to the Parties. Within forty-five (45) 

days of each Panel meeting, the Panel Administrator shall submit a final written report, on behalf 

of the Panel, to EPA and DuPont, that addresses the charge or charges under consideration at 

such meeting. 

b. Final Panel Reports submitted to AR 226. Within thirty (30) days 

after the Panel Administrator has submitted a final written report to EPA and DuPont, such final 

written report and a sanitized version of such final written report shall be submitted to AR 226. 

VI. Miscellaneous 

A. Eligible SEP Costs 

1. The cost for providing sufficient quantities, as described in Sections II.D-E, 

above, of the Fluorotelomer Products for characterization, biodegradation pilot tests, and 

biodegradation studies shall not be an eligible SEP Cost. 

2. The cost of preparing sufficient quantities, as described in Sections II.D-E, for 

characterization of Corresponding Polymers identified for pilot testing in Attachment A, and up 

to two additional Corresponding Polymers that the Panel recommends pursuant to charge 

V.A.2.c, shall not be an eligible SEP Cost. 

3. The cost of preparing sufficient quantities, as described in Sections II.D-E, for 

biodegradation pilot tests of the Corresponding Polymers, as identified on Attachment A, shall 

not be an eligible SEP cost. 

4. The cost of preparing sufficient quantities, as described in Sections II.D-E, for 

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7

8

9

10

11

12

13

biodegradation studies of up to two of the Corresponding Polymers that the Panel identifies 

pursuant to charge V.A.2.c, shall not be an eligible SEP cost. 

B. The title, section headings, and sub-headings used in this Appendix A are intended 

by the parties to assist in reading the document and have no legal meaning or effect. 

C. Unless otherwise indicated, the word “days” as used in this Appendix refers to 

calendar days. 

D. Unless otherwise provided in this Appendix or its Attachments, terms shall have the 

same meaning as provided in 15 U.S.C §§ 2601 et seq. and 40 C.F.R. Parts 2 and 792. Terms 

not defined in 15 U.S.C §§ 2601 et seq. and 40 C.F.R. Parts 2 and 792, but that are defined in 

this Appendix or its Attachments, shall be given the meaning as defined in this Appendix or its 

Attachments. 

E. Except as otherwise provided, all communications between the parties, including 

DuPont’s third party contractors, shall be in writing. 

46
APPENDIX A – BIODEGRADATION SUPPLEMENTAL ENVIRONMENTAL PROJECT

ATTACHMENT A 

The following table (which contains Toxic Substances Control Act Confidential Business 

Information) identifies the sequence and grouping of: (1) biodegradation pilot tests for the nine 

commercial fluorotelomer-based products identified in Table 1 of this Attachment 

(“Fluorotelomer Products”), (2) biodegradation pilot tests for corresponding synthesized or 

purified polymers equivalent to the Fluorotelomer Products with respect to the chemical 

composition that creates their fluorotelomer functionality (“Corresponding Polymers”), (3) 

biodegradation studies for the Fluorotelomer Products, and (4) biodegradation studies for any 

Corresponding Polymers. 

The first column, Pilot Test Group, identifies the order of the Fluorotelomer Products (and their 

Corresponding Polymers) for pilot testing and then specifies which of the Fluorotelomer Products 

(and their Corresponding Polymers) should be grouped together for purposes of pilot testing. In 

both the pilot phase and when conducting the biodegradation studies, the laboratory shall test the 

Fluorotelomer Products separately from the Corresponding Polymers. The laboratory shall follow 

the alphabetical sequence (i.e., A, B, C, D) to determine the order for the Fluorotelomer Product 

pilot tests. The laboratory shall follow the numerical sequence within a group (i.e., A1, A2, A3) 

to determine which Fluorotelomer Products (and their Corresponding Polymers) in the group 

should be pilot tested first. 

The laboratory shall determine whether to pilot test the second or third chemical in a group (e.g., 

in the A group, A2 and/or A3), by using the following approach. Using the A group as an 

example, if the test substances in A1 (the Fluorotelomer Product and its Corresponding Polymers) 

can be evenly dispersed in the experimental matrix and the 8-2 FTOH and PFOA analytes are 

quantifiable in the test system, the laboratory shall not pilot A2 or A3, because the criteria 

established in A1 should be applicable to A2 and A3. However, if any of the test substances in 

A1 do not remain dispersed in the experimental matrix or if the 8-2 FTOH and PFOA analytes are 

not quantifiable in the test system, the laboratory shall make appropriate adjustments during the 

pilot of A1 and shall pilot A2, applying the adjustments it made during the pilot of A1 in its pilot 

of A2. If any of the test substances in A2 do not remain dispersed in the experimental matrix or if 

the 8-2 FTOH and PFOA analytes are not quantifiable in the test system, the laboratory shall 

make appropriate adjustments during the pilot of A2 and shall pilot A3, applying the adjustments 

it made during the pilot of A2 in its pilot of A3. The laboratory shall follow this pilot testing 

approach for groups A, B, C, and D. 

The second column, Test Sequence Group, identifies the order of the Fluorotelomer Products and 

their Corresponding Polymers for biodegradation studies. This column identifies which 

Fluorotelomer Products and Corresponding Polymers can be grouped together for biodegradation 

studies, to maximize laboratory efficiency, capacity allowing. If the laboratory does not have the 

capacity to perform the biodegradation studies on multiple chemicals at one time, then the 

laboratory shall follow the sequence order by Group number and Substance number to establish 

the testing sequence for each Fluorotelomer Product and any Corresponding Polymers. 

The TPL shall run the first pilot (i.e., the pilot for test substance A1) and the 8-2 Alcohol control 

pilot concurrently. 
Table 1 (Non-CBI) 

Pilot Test Group Test Sequence Order Non-CBI Chemical Name Control 1 Telomer B Alcohol 

1-Decanol,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10-heptadecafluoro

A1 Group 1 Substance 2 Polysubstituted urethane A2 Group 1 Substance 3 Polysubstituted urethane A3 Group 1 Substance 1 Fluorinated substituted urethane B Group 2 Substance 1 Polysubstituted phosphate salt C1 Group 3 Substance 3 Polysubstituted acrylic copolymer C2 Group 3 Substance 2 Perfluoroalkyl acrylate copolymer latex C3 Group 3 Substance 1 Perfluoroalkyl acrylate copolymer latex D1 Group 4 Substance 1 Polysubstituted acrylic copolymer D2 Group 4 Substance 2 Polysubstituted methacrylic copolymer 
APPENDIX A – BIODEGRADATION SUPPLEMENTAL ENVIRONMENTAL PROJECT

ATTACHMENT B: 

Characterization of Fluorotelomer Products and Corresponding Polymers

I. Purposes 

The characterization of the nine commercial fluorotelomer-based products identified in 

Table 1 of Attachment A to this Appendix (“Fluorotelomer Products”) and the corresponding 

synthesized or purified polymers equivalent to the Fluorotelomer Products with respect to the 

chemical composition that creates their fluorotelomer functionality (“Corresponding Polymers”) 

serves the following purposes: 

A. To Address the identity, purity, quantity and composition of the Fluorotelomer

 Products and Corresponding Polymers. 

B. To Explain the outcome of the biodegradation studies performed on the

 Fluorotelomer Products and Corresponding Polymers. 

II. Characterization Procedures 

A. Analysis of Fluorotelomer Products and Corresponding Polymers 

The laboratory performing characterization of the Fluorotelomer Products and 

Corresponding Polymers shall determine the molecular weight distribution of each 

Fluorotelomer Product and any Corresponding Polymers. The Fluorotelomer Products and 

Corresponding Polymers shall be dissolved in AK-225G:THF. If the laboratory determines that 

AK-225G:THF is not an effective solvent, the laboratory shall use another, more effective, 

solvent. The actual solvent that the laboratory uses shall be documented in laboratory records 

and the reasoning for the alternative choice provided to EPA as part of the final report. The 

laboratory shall determine the weight percent of undissolved solids and provide such information 

to EPA as part of the final report. 

The laboratory shall wash or leach the Fluorotelomer Products and any Purified 

Fluorotelomer Products, as that term is defined in Appendix A, using a scientifically acceptable 

method that is approved by EPA. 

The laboratory shall determine the number average molecular weight and weight average 

molecular weight of the dissolved Fluorotelomer Products and Corresponding Polymers by size 

exclusion chromatography (“SEC”) pursuant to OECD Guidelines 118 ("Determination of the 

Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using 

Gel Permeation Chromatography") and 119 ("Determination of the Low Molecular Weight 

Content of a Polymer using Gel Permeation Chromatography"). The laboratory shall use 

Polymethyl methacrylate (PMMA) or another appropriate polymer standard. Molecular Weight 

1
(MW) of the standards must bracket the MW of the Fluorotelomer Products and Corresponding 

Polymers being determined. 

B. Concentration of impurities in Fluorotelomer Products and Corresponding 

Polymers 

The laboratory shall measure the levels of impurities specified in Table 1 of this 

Attachment using the most accurate instrumentation and procedures as of the time of testing. 

Values shall be expressed in weight concentrations (mg analyte /kg polymer) and mole 

concentrations (mole analyte /kg polymer). The final report shall include test and reference 

standards, equipment, preparation of standards and samples, calibration curve with at least five 

standards and r2 >0.99, fortifications bracketing the sample concentrations, and documentation 

that standard recoveries of 70 to 130% were achieved. 

C. Analysis of total fluorine 

The laboratory shall combust reference standards and blanks using Wickbold torch 

method. Mineralized inorganic fluoride (F-) shall be trapped in distilled water or aqueous 

sodium hydroxide. Fluoride ions shall be quantitated with fluoride ion selective electrode or ion 

chromatography. Values shall be expressed in weight concentrations (mg /kg polymer) and mole 

concentrations (mole /kg polymer). Successful recovery of the reference standard is defined as 

70-130%. Following successful recovery of the reference standard, the Fluorotelomer Products 

and Corresponding Polymers shall be combusted and total fluorine of the combusted 

Fluorotelomer products and Corresponding Polymers shall be quantified. 

D. Weight percent of total carbon 

The laboratory shall calculate the weight percent of total carbon. 

E. Particle size of solid Corresponding Polymers 

When a Fluorotelomer Product, as a solution, is purified to form its corresponding 

Purified Fluorotelomer Product, it is anticipated that the Purified Fluorotelomer Product may be 

in a solid form. If the Purified Fluorotelomer Product remains as a liquid, no particle size 

determination is possible. If the Purified Fluorotelomer Product is in a solid form, it shall be 

ground to a uniform particle size of < 250 :m under low temperature conditions using liquid 

nitrogen. The ground Purified Fluorotelomer Product preparation will be visually inspected for 

uniformity and particle size < 250 :m. This particle size will help ensure that the Purified 

Fluorotelomer Products will be uniformly suspended in aqueous test solutions. The pilot test 

shall determine whether the studies require addition of the test substance in solid or liquid form. 

2
III. Documentation 

A. The identity of each Fluorotelomer Product and any Corresponding Polymers 

must be documented including: 

1. Name of the polymeric product (including lot or batch number) 

2. Concentration of active ingredient 

3. Date of purification 

B. The following supporting analytical data must be documented for each 

Fluorotelomer Product and any Corresponding Polymers: 

1. Equipment and reagents used to generate data 

2. Test and reference substances 

3. Preparation of standards and samples 

4. Analytical equipment operating conditions 

5. Calibration and analysis results 

6. Calculations 

C. The following characterization data must be documented for each Fluorotelomer 

Product and any Corresponding Polymers, and included in the final report: 

1. Ppm and mole/kg of each impurity listed in Table 1, below. 

2. Molecular weight distribution of each Fluorotelomer Product and 

Corresponding Polymers including: 

a. If >90% solubilized, include % of undissolved solids 

b. Number average molecular weight (Mn) of the polymer fraction 

c. Weight average molecular weight (Mw) of the polymer fraction 

d. Weight of fluorochemical charged to polymer (as manufactured) 

3. Calculation of total carbon weight % 

4. Total organic fluorine 

5. Particle size inspection 

3
Table 1 

List of Analytes 

Name CAS Number 

6-2 Fluorotelomer Alcohol 647-42-7 

8-2 Fluorotelomer Alcohol 678-39-7 

10-2 Fluorotelomer Alcohol 865-86-1 

8-2 Fluorotelomer ethene 21652-58-4 

8-2 Fluorotelomer Iodide 2043-53-0 

10-2 Fluorotelomer Iodide 2043-54-1 

Perfluorooctyl Iodide 507-63-1 

Perfluorodecyl Iodide 423-62-1 

8-2 Fluorotelomer acrylate (only for polyacrylates) 27905-45-9 

8-2 Fluorotelomer saturated Acid 27854-31-5 

8-2-Fluorotelomer unsaturated Acid 70887-84-2 

Perfluorooctanoic Acid 335-67-1 

2-H Perfluorooctanoic Acid 142821-03-2 

Perfluorononanoic Acid 375-95-1 

Perfluorodecanoic Acid 335-76-2 

Perfluoroundecanoic Acid 2058-94-8 

7-3 Fluorotelomer Acid 812-70-4 

7-2 Fluorotelomer iso-ethanol 24015-83-6 

7-2 Fluorotelomer unsaturated Acid 755-03-3 

7-3 Fluorotelomer unsaturated Amide 56017-64-2 

PFOA telomer 8-2 ester 

Octanoic acid, pentadecafluoro-, 

3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl ester 

MW 860 

NA 

4
APPENDIX A – BIODEGRADATION SUPPLEMENTAL ENVIRONMENTAL PROJECT 

ATTACHMENT C 

List of Analytes 

Name CAS Number 

6-2 Fluorotelomer Alcohol 647-42-7 

8-2 Fluorotelomer Alcohol 678-39-7 

10-2 Fluorotelomer Alcohol 865-86-1 

8-2 Fluorotelomer ethene 21652-58-4 

8-2 Fluorotelomer Iodide 2043-53-0 

10-2 Fluorotelomer Iodide 2043-54-1 

Perfluorooctyl Iodide 507-63-1 

Perfluorodecyl Iodide 423-62-1 

8-2 Fluorotelomer acrylate (only for polyacrylates) 27905-45-9 

8-2 Fluorotelomer saturated Acid 27854-31-5 

8-2-Fluorotelomer unsaturated Acid 70887-84-2 

Perfluorooctanoic Acid 335-67-1 

2-H Perfluorooctanoic Acid 142821-03-2 

Perfluorononanoic Acid 375-95-1 

Perfluorodecanoic Acid 335-76-2 

Perfluoroundecanoic Acid 2058-94-8 

7-3 Fluorotelomer Acid 812-70-4 

7-2 Fluorotelomer iso-ethanol 24015-83-6 

7-2 Fluorotelomer unsaturated Acid 755-03-3 

7-3 Fluorotelomer unsaturated Amide 56017-64-2 

1
PFOA telomer 8-2 ester NA 

Octanoic acid, pentadecafluoro-, 

3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl 

ester 

MW 860 

Any other impurities that the laboratory performing the biodegradation studies detects shall be 

identified, and quantified, if possible. 

Analysis 

Analyses shall be conducted using the most accurate instrumentation and procedures as of the 

time of testing. It is anticipated that analytical detection limits for the analytes will be in the sub 

parts per billion. 

All analytical data, including any estimated or laboratory qualified values that are below 

quantitation limits, and all raw data including, but not limited to, laboratory notebook entries, 

chromatographs, and mass spectra will be included in the final reports and in the monthly reports 

submitted under Section III.F.2.g of Appendix A. 

SCAS and OECD Guideline 303A Protocols 

The laboratory shall conduct biodegradation pilot tests and studies on the nine commercial 

fluorotelomer-based products identified in Table 1 of Attachment A to this Appendix 

(“Fluorotelomer Products”) and any corresponding synthesized or purified polymers equivalent 

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

fluorotelomer functionality (“Corresponding Polymers”) following the guidelines for SCAS and 

OECD Guideline 303A provided below. Since these test methods were not developed to test 

polymer materials, appropriate modifications to the protocols may be necessary. Accordingly, 

the laboratory shall develop protocols which shall be approved by EPA prior to initiation of any 

biodegradation studies, including pilot testing. 

2
OECD GUIDELINE FOR THE TESTING OF CHEMICALS

Simulation Test – Aerobic Sewage Treatment

303 A: Activated Sludge Units 

OECD Guideline 303 is subject to copyright and is not included in this Attachment 

C to Appendix A to the Consent Agreement and Final Order, In the Matter of: E. I. 

du Pont de Nemours and Company, Docket Nos. TSCA-HQ-2004-0016, RCRA-HQ2004-0016, TSCA-HQ-2005-5001. 

To purchase a copy of OECD Guideline 303, visit: www.oecdbookshop.org (ISBN # 

9264070427). 

To view a read-only copy of OECD Guideline 303, visit the EPA reading room located in 

EPA’s Docket Center, Rm. B102–Reading Room, EPA West Building, 1301 Constitution 

Ave., NW, Washington, DC. Request to view OPPT-2003-0012-0169. 

The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 

excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 

566–1744 and the telephone number for the OPPT Docket, which is located in the EPA 

Docket Center, is (202) 566–0280. 
United States Prevention, Pesticides EPA 712–C–98–097 

Environmental Protection and Toxic Substances January 1998 

Agency (7101) 

Fate, Transport and 

Transformation Test 

Guidelines 

OPPTS 835.5045 

Modified SCAS Test for 

Insoluble and Volatile 

Chemicals 
INTRODUCTION 

This guideline is one of a series of test guidelines that have been 

developed by the Office of Prevention, Pesticides and Toxic Substances, 

United States Environmental Protection Agency for use in the testing of 

pesticides and toxic substances, and the development of test data that must 

be submitted to the Agency for review under Federal regulations. 

The Office of Prevention, Pesticides and Toxic Substances (OPPTS) 

has developed this guideline through a process of harmonization that 

blended the testing guidance and requirements that existed in the Office 

of Pollution Prevention and Toxics (OPPT) and appeared in Title 40, 

Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the 

Office of Pesticide Programs (OPP) which appeared in publications of the 

National Technical Information Service (NTIS) and the guidelines published by the Organization for Economic Cooperation and Development 

(OECD). 

The purpose of harmonizing these guidelines into a single set of 

OPPTS guidelines is to minimize variations among the testing procedures 

that must be performed to meet the data requirements of the U. S. Environmental Protection Agency under the Toxic Substances Control Act (15 

U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act 

(7 U.S.C. 136, et seq.). 

Final Guideline Release: This guideline is available from the U.S. 

Government Printing Office, Washington, DC 20402 on The Federal Bulletin Board. By modem dial 202–512–1387, telnet and ftp: 

fedbbs.access.gpo.gov (IP 162.140.64.19), or call 202–512–0132 for disks 

or paper copies. This guideline is also available electronically in ASCII 

and PDF (portable document format) from EPA’s World Wide Web site 

(http://www.epa.gov/epahome/research.htm) under the heading ‘‘Researchers and Scientists/Test Methods and Guidelines/OPPTS Harmonized Test 

Guidelines.’’ 

i

OPPTS 835.5045 Modified SCAS test for insoluble and volatile 

chemicals. 

(a) Scope—(1) Applicability. This guideline is intended to meet testing requirements of both the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.) and the Toxic Substances 

Control Act (TSCA) (15 U.S.C. 2601). 

(2) Background. The source material used in developing this harmonized OPPTS test guideline is 40 CFR 795.45 Inherent 

Biodegradability: Modified SCAS Test for chemical Substances That Are 

Water Soluble or Water Insoluble and Volatile.. 

(b) Introductory information— (1) Prerequisites. (i) Water solubility of the test chemical must be established. 

(ii) The organic carbon content of the test chemical must be established. 

(2) Guidance information. (i) Information on the relative proportions 

of the major components of the test chemical will be useful in interpreting 

the results obtained. 

(ii) Information on the toxicity of the chemical may be useful to the 

interpretation of low results and in the selection of appropriate test concentrations. 

(3) Standard documents. This Test Guideline has been based on the 

papers cited under paragraphs (e)(1) and (e)(2) of this guideline. 

(c) Method— (1) Introduction, purpose, scope, relevance, application and limits of test— (i) The method. (A) The method is an adaptation 

of the Soap and Detergent Association Semi-Continuous Activated Sludge 

(SCAS) procedure for assessing the primary biodegradation of 

alkylbenzene sulphonate. The method involves exposure of the chemical 

to relatively high concentrations of microorganisms over a long time period (possibly several months). The viability of the microorganisms is 

maintained over this period by daily addition of a settled sewage feed. 

(B) Since the conditions provided by the test are highly favorable 

to the selection and/or adaptation of microorganisms capable of degrading 

the test chemical, the procedure may also be used to produce microbial 

inocula adapted to selected chemicals for use in other tests. The test is 

applicable to organic chemicals that are water insoluble or water insoluble 

and volatile and that are not inhibitory to bacteria at the test concentration. 

(ii) Reference chemicals. In some cases when investigating a new 

chemical, reference chemicals may be useful; however, specific reference 

chemicals cannot yet be recommended. Data on several chemicals used 

in interlaboratory tests are provided (see following Table 1.) primarily so 

1

that calibration of the method may be performed from time to time and 

to permit comparison of results when another method is employed. 

Table 1.—Examples of Results of SCAS Test on Various Chemicals Used in the 

OECD/EEC Interlaboratory Test 

Ot – Oc Percent 

Test chemical OT (mg/L) biodegradation/ (mg/L) bioelimination 

4-Acetylaminobenzene 17.2 2.0 85 

sulfonate. 

Tetrapropylenebenzene 17.3 8.4 51.4 

sulfonate. 

4-Nitrophenol ............................. 16.9 0.8 95.3 

Diethylene glycol ....................... 16.5 0.2 98.8 

Aniline ....................................... 16.9 1.7 95.9 

Cyclopentane tetracarboxylate .. 17.9 3.2 81.1 

Duration of test is 40 days, except 120 days for cyclopentane tetracarboxylate. 

(iii) Principle of the test method. (A) Activated sludge from a sewage treatment plant is placed in an aeration (SCAS) unit. The test chemical 

and settled domestic sewage are added, and the mixture is aerated for 

23 hours. The aeration is then stopped, the sludge is allowed to settle, 

and the supernatant liquor is removed. The sludge remaining in the aeration chamber is then mixed with a further aliquot of test chemical and 

sewage and the cycle is repeated. 

(B) This method requires use of a chemical-specific analytical technique or 14C-labeled test chemical. The purpose of the method is to determine the fate of the test chemical in a conventional activated sludge treatment plant. To this end, a complete mass balance for the test chemical 

is established by quantifying parent chemical in settled effluent sludge solids (insoluble test chemicals whether volatile or not), effluent plus solids 

(insoluble test chemicals whether volatile or not), and off gases (volatile 

test chemicals only). The identification and quantification of degradation 

products in all phases are recommended, but not required. 

(iv) Quality criteria—(A) Reproducibility. When primary biodegradation is considered, very precise data are obtained for chemicals that 

are extensively degraded. The results reported in the reference under paragraph (e)(1) of this guideline suggest 95-percent confidence limits of less 

than ±3 percent, and this includes interlaboratory tests. As would be expected, wider confidence limits are obtained for less biodegradable chemicals. 

(B) Possibility of standardization. Since the method uses a feed of 

settled sewage, absolute standardization is not possible unless this feed 

were replaced by synthetic sewage. However, since the method is designed 

2

to give an indication of the biodegradability potential of a chemical and 

is not a simulation test such standardization is unnecessary. 

(C) Possibility of automation. Automation of this method would be 

possible but would be expensive. As the method is not labor intensive, 

the exercise would offer few advantages. 

(2) Description of the test procedure—(i) Preparations. (A) The 

aeration units are cleaned and fixed in a suitable support. The air inlet 

tubes are connected to the supply manifold. A small laboratory-scale air 

compressor is used to aerate the units, and the air is presaturated with 

water to reduce evaporation losses from the units. 

(B) If the test chemical is volatile, exhaust gases from the aeration 

units should be passed through a suitable trap (such as Amberlite 

XAD–4, Rohm and Haas, Philadelphia, PA) to remove volatilized 

organics. 

(C) A sample of mixed liquor from an activated sludge plant treating 

predominantly domestic sewage is obtained. Approximately 150 mL of 

the mixed liquor are required for each aeration unit. 

(D) The organic carbon analyzer is calibrated using potassium hydrogen phthalate. 

(E) Stock solutions of the test chemicals are prepared: The concentration normally required is 400 mg/L as organic carbon which gives a test 

chemical concentration of 20 mg/L carbon at the start of each aeration 

cycle if no biodegradation is occurring. 

(F) If the test chemical is insoluble in water at 400 mg/L it may 

be necessary to use ultrasound dispersion to obtain a uniform stable suspension. Alternatively, test chemical may be added directly to the aeration 

units. 

(G) The organic carbon content of the stock solutions is measured. 

(ii) Test conditions. A high concentration of aerobic microorganisms 

is used, and the effective detention period is 36 hours. The carbonaceous 

material in the sewage feed is oxidized extensively within 8 hours of the 

start of each aeration cycle. Thereafter, the sludge respires endogenously 

for the remainder of the aeration period, during which time the only available substrate is the test chemical unless this is also readily metabolized. 

These features, combined with daily reinoculation of the test when domestic sewage is used as the medium, provide highly favorable conditions 

for both adaptation and biodegradation. 

(iii) Performance of the test. (A) A sample of mixed liquor from 

a suitable activated sludge plant is obtained and aerated during transportation to the laboratory. Each aeration unit is filled with 150 mL of mixed 

3

liquor, and aeration is started. After 23 h, aeration is stopped, and the 

sludge is allowed to settle for 45 min. The tap is opened, and 100 mL 

of the supernatant liquor is withdrawn. A sample of settled domestic sewage is obtained immediately before use, and 100 mL is added to the sludge 

remaining in each aeration unit. Aeration is started anew. At this stage 

no test chemicals are added, and the units are fed daily with domestic 

sewage only until a clear supernatant liquor is obtained on settling. This 

usually takes up to 2 weeks, by which time the dissolved organic carbon 

in the supernatant liquor at the end of each aeration cycle should be less 

than 12 mg/L. 

(B) At the end of this period the individual settled sludges are mixed, 

and 50 mL of the resulting composite sludge is added to each unit. 

(C) One hundred milliliters of settled sewage are added to the control 

units, and 95 mL of settled sewage plus 5 mL of the appropriate test chemical stock solution or suspension (400 mg organic carbon/L) to the test 

units. If test chemical is added directly to aeration units, 100 mL of settled 

sewage is added, as in the control units. 

(D) Aeration is started again and continued for 23 h. The sludge is 

then allowed to settle for 45 min and the supernatant drained off and analyzed for parent chemical. Before analysis the liquors are filtered through 

washed 0.45 μm membrane filters and certifuged. Temperature of the sample must not exceed 40 °C while it is in the centrifuge. 

(E) If the test chemical is insoluble or expected to sorb significantly 

to sludge solids, settled sludge is also collected by an appropriate means 

(such as centrifugation) and extracted to remove test chemical, and the 

extract is analyzed for parent chemical. 

(F) If the test chemical is volatile, traps for removing volatile organics 

from exhaust gases are also extracted and the extracts analyzed for parent 

chemical. 

(G) The fill and draw procedure under paragraphs (c)(2)(iii)(C) 

through (c)(2)(iii)(F) of this guideline is repeated daily throughout the test. 

(H) Before settling, it may be necessary to clean the walls of the 

units to prevent the accumulation of solids above the level of the liquid. 

A separate scraper or brush is used for each unit to prevent cross contamination. 

(I) The length of the test for chemicals showing little or no biodegradation is indeterminate, but experience suggests that this should be at 

least 12 weeks. 

(d) Data and reporting—(1) Treatment of the results. (i) The concentration of parent chemical in settled effluent sludge solids (insoluble 

test chemicals whether volatile or not), effluent plus solids (insoluble test 

4

chemicals whether volatile or not), and off-gases (volatile test chemicals 

only) is plotted versus time for the test units. As biodegradation is 

achieved the level of the test chemical will decrease and approach a steady 

state. Once the levels of the test chemical are found to be constant over 

three consecutive measurements, three further measurements are made. 

(ii) An example of the application of specific analytical technique 

to the SCAS test is discussed in the reference in paragraph (e)(2) of this 

guideline. 

(e) References. The following references should be consulted for additional background information on this test guideline. 

(1) A Procedure and Standards for the Determination of the 

Biodegradability of Alkyl Benzene Sulfonate and Linear Alkylate 

Sulfonate. Journal of the American Oil Chemists Society 42:986 (1965). 

(2) Games, L.M. et al. Fate and distribution of a quaternary ammonium surfactant octadecyltrimethylammonium chloride (OTAC), in 

wastewater treatment. Environmental Science and Technology 16:483–488 

(1982). 

5

APPENDIX A – BIODEGRADATION SUPPLEMENTAL ENVIRONMENTAL PROJECT 

ATTACHMENT D: 

Chain of Custody Procedures for Shipping Test Substances 

I. Purpose 

In order to ensure accurate generation of test substances and data, DuPont and/or the 

laboratories used by DuPont handling test substances and conducting tests and studies must 

follow acceptable procedures that document and/or explain how the test substances were 

packed and shipped. This Attachment outlines the minimum procedures that must be followed 

and the documentation that must be retained for the study records when packing and shipping 

test substances. As used in this Attachment, test substances include, the nine commercial 

fluorotelomer-based products identified in Table 1 of Attachment A to this Appendix 

(“Fluorotelomer Products”), corresponding synthesized or purified polymers equivalent to the 

Fluorotelomer Products with respect to the chemical composition that creates their 

fluorotelomer functionality (“Corresponding Polymers”), and other chemicals. 

II. Test Substance Identification 

Before a test substance can be shipped, each test substance must have a unique identification 

number and this number must be entered on the chain of custody form and test substance 

information form. DuPont or the laboratory preparing or providing the test substance must 

provide the name of the test substance, the identification number and the date by which the test 

substance will be ready for shipment either to EPA or to another third party laboratory, which 

ever is applicable. 

A copy of the chain of custody form must be included in the package containing the test 

substance to be sent to either EPA or to another third party laboratory, with the test substance 

information form. The identification number serves to relate the test substance with 

information on the activities and conditions that fully describe the origin of the test substance. 

Test substance identification will also include a project number in order to link the test 

substance with a specific study. 

III. Packaging Test Substances 

For test substances that are not regulated by DOT, place the volume of each test substance 

specified by the study protocol into duplicate containers appropriate for shipment. Double-bag 

each test substance, using zip-lock plastic bags. Complete the Identification Sheet for the 

study records. For test substances that are regulated by DOT, ship in separate 30 mL 

containers and use the numbering system as specified above. Also include on each label 

number X of total number Y. 

IV. Shipping to Laboratories and to EPA 

A. Packing 

Each test substance should be labeled with the identification number. Fluorotelomer 

Products and Corresponding Polymers should not be shipped in the same package to 

reduce the potential for contamination. To avoid contamination, sampling equipment and 

Page 1 of 3 
containers made from fluoropolymers should be avoided. Carefully cleaned 

polypropylene and polystyrene sample containers and centrifuge tubes have been 

satisfactorily used for the analysis of fluorinated compounds. However, all containers 

that come in contact with treated and untreated test substances must be confirmed to be 

free of PFOA. Containers that are not free of PFOA should be triple washed in high 

purity organic solvent, i.e., methanol, acetonitrile or isopropanol, and reconfirmed to be 

free of PFOA before use. The use of disposable labware is recommended, i.e., pipets. 

The containers should be placed in a zip-lock plastic bag that is labeled with the test 

substance Identification Number and Project Number as described above. Be sure that 

the bag is tightly closed and puncture-free. Place the label with the identification number, 

project number and lot number on the outside of the inner plastic bag. Include the chain 

of custody form and the MSDS in the box(es) containing the test substances. Follow all 

appropriate shipment requirements. 

B. Material Safety Data Sheets 

Appropriate MSD sheets should be included. Ensure that the MSD sheet can be removed 

from the box without disturbing the packing contents. Place the MSD sheet in an 

envelope and place the envelope on top of the test substances in the box. The chain of 

custody form must also be placed in the box. 

C. Shipping Papers 

The chain of custody form serves as a packing list for the shipment and to document the 

contents of the shipment. It must accurately reflect the contents of the shipment. It is to 

be included in the package with the test substance(s). 

Each chain of custody form must include the following: 

 -Project number 

-Unique test substance number of each test substance in the shipment 

-Unique shipment number 

-Signature of investigator responsible for test substances and date on which the 

 shipment left this person’s custody 

The packer of the shipment has the responsibility to verify that the test substance listed 

on the chain of custody form corresponds to the test substance actually shipped and that 

the test substance description on the chain of custody form is accurate. Any 

discrepancies must be rectified before the test substance is shipped. 

The chain of custody form must be placed in the box. Place the chain of custody form in 

an envelope and place the envelope on top of the test substances in the box. 

D. Commercial Air Delivery Service 

Ship each package using a door-to-door carrier so that the package/articles will arrive 

during the normal 5-day workweek. Do not ship packages if the arrival date does not fall 

on a business work day. 

Page 2 of 3 
E. Airbills/Bill-of Lading 

A separate Airbill or the like is preferred for each shipment number, even if several 

different shipment numbers are sent at the same time. In this way, one Airbill can be 

associated with one shipment number. If this is not practical, at least clearly indicate on 

the Airbill each shipment number that was included in the shipment. A space is generally 

provided by the shipper for special notations. 

When samples are surrendered to a carrier, documentation must be obtained from the 

carrier such as a copy of the Airbill or Bill-of-Lading that indicates that the chain of 

custody of the shipment has been transferred to the carrier. This document must bear the 

shipment number, the carrier’s name, the date of transfer of custody, and signature of the 

sender. This documentation must be retained and become part of the study records. 

Retain the original Airbill for the study records. 

F. Shipment Notification 

Immediately upon shipment, notify the recipient and include:

Date of Shipment 

Carrier

Overnight or Two-day delivery 

Date of Anticipated Arrival 

Tracking Number 

Approximate Size of Package 

Approximate Weight of Package 

Type of Test Substance 

Page 3 of 3 
Quality

Quality Quality 

United States Office of Environmental EPA/240/B-01/003 

Environmental Protection Information March 2001 

Agency Washington, DC 20460 

EPA Requirements for Quality 

Assurance Project Plans 

EPA QA/R-5 

FOREWORD 

The U.S. Environmental Protection Agency (EPA) has developed the Quality Assurance 

Project Plan (QA Project Plan) as a tool for project managers and planners to document the type 

and quality of data needed for environmental decisions and to describe the methods for collecting 

and assessing those data. The development, review, approval, and implementation of the QA 

Project Plan is part of EPA’s mandatory Quality System. The EPA Quality System requires all 

organizations to develop and operate management structures and processes to ensure that data 

used in Agency decisions are of the type and quality needed for their intended use. The QA 

Project Plan is an integral part of the fundamental principles and practices that form the 

foundation of the EPA Quality System. 

This document provides the QA Project Plan requirements for organizations that conduct 

environmental data operations on behalf of EPA through contracts, financial assistance 

agreements, and interagency agreements; however, it may be used by EPA as well. It contains the 

same requirements as Chapter 5 of EPA Order 5360 A1 (EPA 2000), The EPA Quality Manual 

for Environmental Programs, which has been developed for internal use by EPA organizations. 

A companion document, EPA Guidance for Quality Assurance Project Plans (QA/G-5) (EPA 

1998) provides suggestions for both EPA and non-EPA organizations on preparing, reviewing, 

and implementing QA Project Plans that satisfy the requirements defined in this document. 

This document is one of the EPA Quality System Series documents which describe EPA 

policies and procedures for planning, implementing, and assessing the effectiveness of a quality 

system. Questions regarding this document or other EPA Quality System Series documents 

should be directed to: 

U.S. EPA 

Quality Staff (2811R) 

Washington, DC 20460 

Phone: (202) 564-6830 

FAX: (202) 565-2441 

e-mail: quality@epa.gov 

Copies of Quality System Series documents may be obtained from the Quality Staff or by 

downloading them from the Quality Staff Home Page: 

www.epa.gov/quality 

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EPA QA/R-5 i March 2001 
ACKNOWLEDGMENTS

This document reflects the collaborative efforts of many quality management professionals 

who participate in the challenge for continual improvement in quality systems supporting 

environmental programs. These individuals, representing the EPA, other Federal agencies, State 

and local governments, and private industry, reflect a diverse and broad range of needs and 

experiences in environmental data collection programs. Their contributions and the 

comprehensive reviews during the development of this document are greatly appreciated. 

Final 

EPA QA/R-5 ii March 2001 
TABLE OF CONTENTS

Page 

CHAPTER 1. INTRODUCTION ............................................. 1

1.1 BACKGROUND ................................................ 1

1.2 QA PROJECT PLANS, THE EPA QUALITY SYSTEM, AND 

ANSI/ASQC E4-1994 ................................. ........... 2

1.3 THE GRADED APPROACH AND THE EPA QUALITY SYSTEM ........ 4

1.4 INTENDED AUDIENCE ......................................... 4

1.5 PERIOD OF APPLICABILITY ..................................... 4

1.6 ADDITIONAL RESOURCES ...................................... 4

1.7 SUPERSESSION . ............................................... 5

CHAPTER 2. QA PROJECT PLAN REQUIREMENTS .......................... 7

2.1 POLICY ....................................................... 7

2.2 PURPOSE ..................................................... 7

2.3 APPLICABILITY ............................................... 7

2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS ................ 7

2.4.1 General Content ........................................... 7

2.4.2 Level of Detail . ........................................... 8

2.5 QA PROJECT PLAN PREPARATION AND APPROVAL ................ 8

2.6 QA PROJECT PLAN IMPLEMENTATION ........................... 9

2.7 QA PROJECT PLAN REVISION ................................... 9

CHAPTER 3. QA PROJECT PLAN ELEMENTS . .............................. 11

3.1 CONTENT REQUIREMENTS .................................... 11

3.2 GROUP A: PROJECT MANAGEMENT ............................ 12

3.2.1 A1 - Title and Approval Sheet . ............................... 13

3.2.2 A2 - Table of Contents ..................................... 13

3.2.3 A3 - Distribution List ...................................... 14

3.2.4 A4 - Project/Task Organization ............................... 14

3.2.5 A5 - Problem Definition/Background .......................... 14

3.2.6 A6 - Project/Task Description . ............................... 14

3.2.7 A7 - Quality Objectives and Criteria ........................... 15

3.2.8 A8 - Special Training/Certification ............................ 15

3.2.9 A9 - Documents and Records ................................ 15

3.3 GROUP B: DATA GENERATION AND ACQUISITION ............... 15

3.3.1 B1- Sampling Process Design (Experimental Design) .............. 16

3.3.2 B2 - Sampling Methods .................................... 17

3.3.3 B3 - Sample Handling and Custody ............................ 17

3.3.4 B4 - Analytical Methods .................................... 17

3.3.5 B5 - Quality Control . ...................................... 18

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EPA QA/R-5 iii March 2001 
Page 

3.3.6 B6 - Instrument/Equipment Testing, Inspection, and Maintenance . .... 18

3.3.7 B7 - Instrument/Equipment Calibration and Frequency ............. 18

3.3.8 B8 - Inspection/Acceptance of Supplies and Consumables . .......... 19

3.3.9 B9 - Non-direct Measurements ............................... 19

3.3.10 B10 - Data Management . ................................... 19

3.4 GROUP C: ASSESSMENT AND OVERSIGHT ...................... 20

3.4.1 C1 - Assessments and Response Actions ........................ 20

3.4.2 C2 - Reports to Management ................................ 20

3.5 GROUP D: DATA VALIDATION AND USABILITY . ................. 21

3.5.1 D1 - Data Review, Verification, and Validation . .................. 21

3.5.2 D2 - Verification and Validation Methods . ...................... 21

3.5.3 D3 - Reconciliation with User Requirements ..................... 21

REFERENCES ........................................................... 23

APPENDIX A. CROSSWALKS AMONG QUALITY ASSURANCE DOCUMENTS . A-1

A.1 BACKGROUND . ............................................. A-1

A.2 CROSSWALK BETWEEN EPA QA/R-5 AND QAMS-005/80 . .......... A-1

A.3 CROSSWALK BETWEEN THE DQO PROCESS 

AND THE QA PROJECT PLAN .............. .................... A-3

APPENDIX B. TERMS AND DEFINITIONS ................................. B-1

FIGURES 

Page 

1. EPA Quality System Components and Tools . .................................... 3

2. Example Document Control Format .......................................... 14

TABLES 

Page 

1. Group A: Project Management Elements . ..................................... 13

2. Group B: Data Generation and Acquisition Elements . ............................ 16

3. Group C: Assessment and Oversight Elements .................................. 20

4. Group D: Data Validation and Usability Elements . ............................... 21

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EPA QA/R-5 iv March 2001 
CHAPTER 1 

INTRODUCTION 

1.1 BACKGROUND 

Environmental programs conducted by or funded by the U.S. Environmental Protection 

Agency (EPA) involve many diverse activities that address complex environmental issues. The 

EPA annually spends several hundred million dollars in the collection of environmental data for 

scientific research and regulatory decision making. In addition, non-EPA organizations may 

spend as much as an order of magnitude more each year to respond to Agency requirements. If 

decision makers (EPA and otherwise) are to have confidence in the quality of environmental data 

used to support their decisions, there must be a structured process for quality in place. 

A structured system that describes the policies and procedures for ensuring that work 

processes, products, or services satisfy stated expectations or specifications is called a quality 

system. All organizations conducting environmental programs funded by EPA are required to 

establish and implement a quality system. EPA also requires that all environmental data used in 

decision making be supported by an approved Quality Assurance Project Plan (QA Project Plan). 

This requirement is defined in EPA Order 5360.1 A2 (EPA 2000), Policy and Program 

Requirements for the Mandatory Agency-wide Quality System, for EPA organizations. Non-EPA 

organizations funded by EPA are required to develop a QA Project Plan through: 

C 48 CFR 46, for contractors; 

C 40 CFR 30, 31, and 35 for assistance agreement recipients; and 

C other mechanisms, such as consent agreements in enforcement actions. 

The QA Project Plan integrates all technical and quality aspects of a project, including 

planning, implementation, and assessment. The purpose of the QA Project Plan is to document 

planning results for environmental data operations and to provide a project-specific “blueprint” 

for obtaining the type and quality of environmental data needed for a specific decision or use. The 

QA Project Plan documents how quality assurance (QA) and quality control (QC) are applied to 

an environmental data operation to assure that the results obtained are of the type and quality 

needed and expected. 

The ultimate success of an environmental program or project depends on the quality of the 

environmental data collected and used in decision-making, and this may depend significantly on 

the adequacy of the QA Project Plan and its effective implementation. Stakeholders (i.e., the data 

users, data producers, decision makers, etc.) shall be involved in the planning process for a 

program or project to ensure that their needs are defined adequately and addressed. While time 

spent on such planning may seem unproductive and costly, the penalty for ineffective planning 

Final 

EPA QA/R-5 1 March 2001 
includes greater cost and lost time. Therefore, EPA requires that a systematic planning process be 

used to plan all environmental data operations. To support this requirement, EPA has developed 

a process called the Data Quality Objectives (DQO) Process. The DQO Process is the Agency’s 

preferred planning process and is described in the Guidance for the Data Quality Objectives 

Process (QA/G-4) (EPA 2000b). The QA Project Plan documents the outputs from systematic 

planning. 

This requirements document presents specifications and instructions for the information 

that must be contained in a QA Project Plan for environmental data operations funded by EPA. 

The document also discusses the procedures for review, approval, implementation, and revision of 

QA Project Plans. Users of this document should assume that all of the elements described herein 

are required in a QA Project Plan unless otherwise directed by EPA. 

1.2 QA PROJECT PLANS, THE EPA QUALITY SYSTEM, AND ANSI/ASQC 

E4-1994 

EPA Order 5360.1 A2 and the applicable Federal regulations (defined above) establish a 

mandatory Quality System that applies to all EPA organizations and organizations funded by 

EPA. Components of the EPA Quality System are illustrated in Figure 1. Organizations must 

ensure that data collected for the characterization of environmental processes and conditions are 

of the appropriate type and quality for their intended use and that environmental technologies are 

designed, constructed, and operated according to defined expectations. The QA Project Plan is a 

key project-level component of the EPA Quality System. 

EPA policy is based on the national consensus standard, ANSI/ASQC E4-1994, 

Specifications and Guidelines for Environmental Data Collection and Environmental 

Technology Programs. The ANSI/ASQC E4-1994 standard describes the necessary management 

and technical elements for developing and implementing a quality system. This standard 

recommends using a tiered approach to a quality system. This standard recommends first 

documenting each organization-wide quality system in a Quality Management Plan or Quality 

Manual (to address requirements of Part A: Management Systems of the standard) and then 

documenting the applicability of the quality system to technical activity-specific efforts in a QA 

Project Plan or similar document (to address the requirements of Part B: Collection and 

Evaluation of Environmental Data of the standard). EPA has adopted this tiered approach for its 

mandatory Agency-wide Quality System. This document addresses Part B requirements of the 

standard. 

A Quality Management Plan, or equivalent Quality Manual, documents how an 

organization structures its quality system, defines and assigns QA and QC responsibilities, and 

describes the processes and procedures used to plan, implement, and assess the effectiveness of 

the quality system. The Quality Management Plan may be viewed as the “umbrella” document 

under which individual projects are conducted. EPA requirements for Quality Management Plans 

are defined in EPA Requirements for Quality Management Plans (QA/R-2) (EPA 2001). The 

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EPA QA/R-5 2 March 2001 
ORGANIZATION/PROGRAM

PROJECT 

POLICY 

Defensible Products and Decisions 

EPA Program & 

Regional Policy 

External Policies 

Contracts - 48 CFR 46 

Assistance Agreements -

40 CFR 30, 31, and 35 

Internal EPA Policies 

EPA Order 5360.1 

EPA Manual 5360 

Consensus Standards 

ANSI/ASQC E4 

ISO 9000 Series 

Annual Review 

and Planning 

(e.g., QAARWP) 

Systems 

Assessments 

(e.g., QSAs) 

Quality System 

Documentation 

(e.g., QMP) 

Training/Communication 

(e.g., Training Plan, 

Conferences) 

Supporting System Elements 

(e.g., Procurements, 

Computer Hardware/Software) 

Technical 

Assessments 

PLANNING IMPLEMENTATION ASSESSMENT 

Conduct Study/ 

Experiment 

QA 

Project Plan 

Systematic 

Planning 

(e.g., DQO Process) 

Standard 

Operating 

Procedures 

Data Quality 

Assessment 

Data Verification 

& Validation 

Figure 1. EPA Quality System Components and Tools 

Final 

EPA QA/R-5 3 March 2001 
Quality Management Plan is then supported by project-specific QA Project Plans. In some cases, 

a QA Project Plan and a Quality Management Plan may be combined into a single document that 

contains both organizational and project-specific elements. The QA Manager for the EPA 

organization sponsoring the work has the authority to determine when a single document is 

applicable and will define the content requirements of such a document. 

1.3 THE GRADED APPROACH AND THE EPA QUALITY SYSTEM 

Recognizing that a “one size fits all” approach to quality requirements will not work in 

organizations as diverse as EPA, implementation of the EPA Quality System is based on the 

principle of graded approach. Applying a graded approach means that quality systems for 

different organizations and programs will vary according to the specific objectives and needs of 

the organization. For example, the quality expectations of a fundamental research program are 

different from that of a regulatory compliance program because the purpose or intended use of the 

data is different. The specific application of the graded approach principle to QA Project Plans is 

described in Section 2.4.2. 

1.4 INTENDED AUDIENCE 

This document specifies the requirements for developing QA Project Plans for 

organizations that conduct environmental data operations funded by EPA through contracts, 

financial assistance agreements, and interagency agreements. EPA organizations may also use this 

document to develop QA Project Plans since this document is clearer and more user-friendly than 

the equivalent requirements defined in Section 5.3 of EPA Order 5360 A1 (EPA 2000), The EPA 

Quality Manual for Environmental Programs (an internal policy document). However, the 

preparation, submission, review, and approval requirements for EPA organizations are still 

contained in Section 5.2 of EPA Order 5360 A1 as these represent internal EPA policy. 

1.5 PERIOD OF APPLICABILITY 

This document shall be valid for a period of up to five years from the official date of 

publication. After five years, it shall either be reissued without change, revised, or withdrawn 

from the EPA Quality System. 

1.6 ADDITIONAL RESOURCES 

Guidance on preparing QA Project Plans may be found in a companion document, EPA 

Guidance for Quality Assurance Project Plans (QA/G-5) (EPA 1998). This guidance discusses 

the application of the QA Project Plan requirements and provides examples. Other documents 

that provide guidance on activities critical to successful environmental data operations and 

complement the QA Project Plan preparation effort include: 

Final 

EPA QA/R-5 4 March 2001 
C 

C Guidance for the Data Quality Objectives Process (QA/G-4), (EPA 2000b) 

C Guidance for the Preparation of Standard Operating Procedures for QualityRelated Documents (QA/G-6), (EPA 1995) 

Guidance for Data Quality Assessment: Practical Methods for Data Analysis 

(QA/G-9), (EPA 2000a) 

1.7 SUPERSESSION 

This document replaces QAMS-005/80, Interim Guidelines and Specifications for 

Preparing Quality Assurance Project Plans (EPA 1980) in its entirety. 

Final 

EPA QA/R-5 5 March 2001 
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Final 

EPA QA/R-5 6 March 2001 
CHAPTER 2 

QA PROJECT PLAN REQUIREMENTS 

2.1 POLICY 

All work funded by EPA that involves the acquisition of environmental data generated 

from direct measurement activities, collected from other sources, or compiled from computerized 

data bases and information systems shall be implemented in accordance with an approved QA 

Project Plan. The QA Project Plan will be developed using a systematic planning process based 

on the graded approach. No work covered by this requirement shall be implemented without an 

approved QA Project Plan available prior to the start of the work except under circumstances 

requiring immediate action to protect human health and the environment or operations conducted 

under police powers. 

2.2 PURPOSE 

The QA Project Plan documents the planning, implementation, and assessment procedures 

of, and how specific QA and QC activities will be applied during a particular project. The QA 

Project Plan demonstrates conformance to Part B requirements of ANSI/ASQC E4-1994. 

2.3 APPLICABILITY 

These requirements apply to all environmental programs funded by EPA that acquire, 

generate, or compile environmental data including work performed through contracts, work 

assignments, delivery orders, task orders, cooperative agreements, interagency agreements, StateEPA agreements, State, local and Tribal Financial Assistance/Grants, Research Grants, and in 

response to statutory or regulatory requirements and consent agreements. These requirements are 

negotiated into interagency agreements, including sub-agreements, and, in some cases, are 

included in enforcement settlement and consent agreements and orders. Where specific Federal 

regulations require the application of QA and QC activities (see Section 1.1), QA Project Plans 

shall be prepared, reviewed, and approved in accordance with the specifications contained in this 

document unless explicitly superseded by the regulation. 

2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS 

2.4.1 General Content 

The QA Project Plan must be composed of standardized, recognizable elements covering 

the entire project from planning, through implementation, to assessment. Chapter 3 of this 

document describes specific elements to address for QA Project Plans submitted to EPA. In some 

cases, it may be necessary to add special requirements to the QA Project Plan. The EPA 

organization sponsoring the work has the authority to define any special requirements beyond 

Final 

EPA QA/R-5 7 March 2001 
those listed in this document. If no additional requirements are specified, the QA Project Plan 

shall address all required elements. Each EPA organization defines their organizational-specific 

requirements for QA Project Plan documentation in their Quality Management Plan. All 

applicable elements defined by the EPA organization sponsoring the work must be addressed. 

While most QA Project Plans will describe project- or task-specific activities, there may be 

occasions when a generic QA Project Plan may be more appropriate. A generic QA Project Plan 

addresses the general, common activities of a program that are to be conducted at multiple 

locations or over a long period of time; for example, it may be useful for a large monitoring 

program that uses the same methodology at different locations. A generic QA Project Plan 

describes, in a single document, the information that is not site or time-specific but applies 

throughout the program. Application-specific information is then added to the approved QA 

Project Plan as that information becomes known or completely defined. A generic QA Project 

Plan shall be reviewed periodically to ensure that its content continues to be valid and applicable 

to the program over time. 

2.4.2 Level of Detail 

The level of detail of the QA Project Plan should be based on a graded approach so that 

the level of detail in each QA Project Plan will vary according to the nature of the work being 

performed and the intended use of the data. As a result, an acceptable QA Project Plan for some 

environmental data operations may require a qualitative discussion of the experimental process 

and its objectives while others may require extensive documentation to adequately describe a 

complex environmental program. 

2.5 QA PROJECT PLAN PREPARATION AND APPROVAL 

The QA Project Plan may be prepared by an EPA organization, a contractor, an assistance 

agreement holder, or another Federal agency under an interagency agreement. Except where 

specifically delegated in the Quality Management Plan of the EPA organization sponsoring the 

work, all QA Project Plans prepared by non-EPA organizations must be approved by EPA before 

implementation. 

The QA Project Plan shall be reviewed and approved by an authorized EPA reviewer to 

ensure that the QA Project Plan contains the appropriate content and level of detail. The 

authorized reviewer, for example the EPA project manager1

 with the assistance and approval of 

the EPA QA Manager or by the EPA QA Manager alone, are defined by the EPA organization’s 

Quality Management Plan. In some cases, the authority to review and approve QA Project Plans 

is delegated to another part of the EPA organization covered by the same Quality Management 

1

 This term refers to the EPA official responsible for the project. This individual may also be called Project Officer, 

Delivery Order Project Officer, Work Assignment Manager, or Principal Investigator. 

Final 

EPA QA/R-5 8 March 2001 
Plan. In cases where the authority to review and approve QA Project Plans is delegated in writing 

by EPA to another organization (i.e., a Federal agency or a State under an EPA-approved Quality 

Management Plan when the environmental data operation itself has been delegated to that 

organization for implementation), it is possible that the EPA project manager and EPA QA 

Manager may not be involved in the review and approval steps. 

2.6 QA PROJECT PLAN IMPLEMENTATION 

None of the environmental work addressed by the QA Project Plan shall be started until 

the QA Project Plan has been approved and distributed to project personnel except in situations 

requiring immediate action to protect human health and the environment or operations conducted 

under police powers. Subject to these exceptions, it is the responsibility of the organization 

performing the work to assure that no environmental data are generated or acquired before the 

QA Project Plan is approved and received by the appropriate project personnel. However, EPA 

may grant conditional approval to a QA Project Plan to permit some work to begin while noncritical deficiencies in the QA Project Plan are being resolved. 

The organization performing the work shall ensure that the QA Project Plan is 

implemented as approved and that all personnel involved in the work have direct access to a 

current version of the QA Project Plan and all other necessary planning, implementation, and 

assessment documents. These personnel should understand the requirements prior to the start of 

data generation activities. 

2.7 QA PROJECT PLAN REVISION 

Although the approved QA Project Plan must be implemented as prescribed; it is not 

inflexible. Because of the complex and diverse nature of environmental data operations, changes 

to original plans are often needed. When such changes occur, the approving official shall 

determine if the change significantly impacts the technical and quality objectives of the project. 

When a substantive change is warranted, the originator of the QA Project Plan shall modify the 

QA Project Plan to document the change and submit the revision for approval by the same 

authorities that performed the original review. Only after the revision has been received and 

approved (at least verbally with written follow-up) by project personnel, shall the change be 

implemented. 

For programs or projects of long duration, such as multi-year monitoring programs or 

projects using a generic QA Project Plan, the QA Project Plans shall be reviewed at least annually 

by the EPA Project Manager (or authorized representative). When revisions are necessary, the 

QA Project Plan must be revised and resubmitted for review and approval. 

Final 

EPA QA/R-5 9 March 2001 
(This page is intentionally blank.) 

Final 

EPA QA/R-5 10 March 2001 
CHAPTER 3 

QA PROJECT PLAN ELEMENTS 

3.1 CONTENT REQUIREMENTS 

The QA Project Plan is a formal document describing in comprehensive detail the 

necessary QA, QC, and other technical activities that must be implemented to ensure that the 

results of the work performed will satisfy the stated performance criteria. The QA Project Plan 

must provide sufficient detail to demonstrate that: 

C the project technical and quality objectives are identified and agreed upon; 

C the intended measurements, data generation, or data acquisition methods are 

appropriate for achieving project objectives; 

C assessment procedures are sufficient for confirming that data of the type and 

quality needed and expected are obtained; and 

C any limitations on the use of the data can be identified and documented. 

Most environmental data operations require the coordinated efforts of many individuals, including 

managers, engineers, scientists, statisticians, and others. The QA Project Plan must integrate the 

contributions and requirements of everyone involved into a clear, concise statement of what is to 

be accomplished, how it will be done, and by whom. It must provide understandable instructions 

to those who must implement the QA Project Plan, such as the field sampling team, the analytical 

laboratory, modelers, and the data reviewers. In all aspects of the QA Project Plan, the use of 

national consensus standards and practices are encouraged. 

In order to be effective, the QA Project Plan must specify the level or degree of QA and 

QC activities needed for the particular environmental data operations. Because this will vary 

according to the purpose and type of work being done, EPA believes that the graded approach 

should be used in planning the work. This means that the QA and QC activities applied to a 

project will be commensurate with: 

C the purpose of the environmental data operation (e.g., enforcement, research and 

development, rulemaking), 

C the type of work to be done (e.g., pollutant monitoring, site characterization, risk 

characterization, bench level proof of concept experiments), and 

C the intended use of the results (e.g., compliance determination, selection of 

remedial technology, development of environmental regulation). 

Final 

EPA QA/R-5 11 March 2001 
The QA Project Plan shall be composed of standardized, recognizable elements covering 

the entire project from planning, through implementation, to assessment. These elements are 

presented in that order and have been arranged for convenience into four general groups. The 

four groups of elements and their intent are summarized as follows: 

A Project Management - The elements in this group address the basic area of project 

management, including the project history and objectives, roles and responsibilities 

of the participants, etc. These elements ensure that the project has a defined goal, 

that the participants understand the goal and the approach to be used, and that the 

planning outputs have been documented. 

B Data Generation and Acquisition - The elements in this group address all aspects 

of project design and implementation. Implementation of these elements ensure 

that appropriate methods for sampling, measurement and analysis, data collection 

or generation, data handling, and QC activities are employed and are properly 

documented. 

C Assessment and Oversight - The elements in this group address the activities for 

assessing the effectiveness of the implementation of the project and associated QA 

and QC activities. The purpose of assessment is to ensure that the QA Project 

Plan is implemented as prescribed. 

D Data Validation and Usability - The elements in this group address the QA 

activities that occur after the data collection or generation phase of the project is 

completed. Implementation of these elements ensures that the data conform to the 

specified criteria, thus achieving the project objectives. 

All applicable elements, including the content and level of detail under each element, 

defined by the EPA organization sponsoring the work must be addressed in the QA Project Plan. 

If an element is not applicable, state this in the QA Project Plan. Documentation, such as an 

approved Work Plan, Standard Operating Procedures, etc., may be referenced in response to a 

particular required QA Project Plan element to reduce the size of the QA Project Plan. Current 

versions of all referenced documents must be attached to the QA Project Plan itself or be placed 

on file with the appropriate EPA office and available for routine referencing when needed. The 

QA Project Plan shall also address related QA planning documentation (e.g., Quality Management 

Plans) from suppliers of services critical to the technical and quality objectives of the project or 

task. 

3.2 GROUP A: PROJECT MANAGEMENT 

The elements in this group (Table 1) address project management, including project 

history and objectives, roles and responsibilities of the participants, etc. These elements document 

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EPA QA/R-5 12 March 2001 
that the project has a defined goal, that the participants understand the goal and the approach to 

be used, and that the planning outputs have been documented. 

Table 1. Group A: Project Management Elements 

A1 Title and Approval Sheet 

A2 Table of Contents 

A3 Distribution List 

A4 Project/Task Organization 

A5 Problem Definition/Background 

A6 Project/Task Description 

A7 Quality Objectives and Criteria 

A8 Special Training/Certification 

A9 Documents and Records 

3.2.1 A1 - Title and Approval Sheet 

On the Title and Approval Sheet, include the title of the plan, the name of the 

organization(s) implementing the project, the effective date of the plan, and the names, titles, 

signatures, and approval dates of appropriate approving officials. Approving officials may 

include: 

- Organization’s Project Manager 

- Organization’s QA Manager 

- EPA Project Manager 

- EPA QA Manager 

- Others, as needed (e.g., field operations manager, laboratory managers, 

State and other Federal agency officials) 

3.2.2 A2 - Table of Contents 

Provide a table of contents for the document, including sections, figures, tables, 

references, and appendices. Apply a document control format (Figure 2) on each page following 

the Title and Approval Sheet when required by the EPA Project Manager and QA Manager. 

Final 

EPA QA/R-5 13 March 2001 
Section No. ______ 

Revision No. _____ 

Date _____________ 

Page ___ of ___ 

Figure 2. Example Document Control Format 

3.2.3 A3 - Distribution List 

List the individuals and their organizations who need copies of the approved QA Project 

Plan and any subsequent revisions, including all persons responsible for implementation (e.g., 

project managers), the QA managers, and representatives of all groups involved. Paper copies 

need not be provided to individuals if equivalent electronic information systems can be used. 

3.2.4 A4 - Project/Task Organization 

Identify the individuals or organizations participating in the project and discuss their 

specific roles and responsibilities. Include the principal data users, the decision makers, the 

project QA manager, and all persons responsible for implementation. The project quality 

assurance manager must be independent of the unit generating the data. (This does not include 

being independent of senior officials, such as corporate managers or agency administrators, who 

are nominally, but not functionally, involved in data generation, data use, or decision making.) 

Identify the individual responsible for maintaining the official, approved QA Project Plan. 

Provide a concise organization chart showing the relationships and the lines of 

communication among all project participants. Include other data users who are outside of the 

organization generating the data, but for whom the data are nevertheless intended. The 

organization chart must also identify any subcontractor relationships relevant to environmental 

data operations, including laboratories providing analytical services. 

3.2.5 A5 - Problem Definition/Background 

State the specific problem to be solved, decision to be made, or outcome to be achieved. 

Include sufficient background information to provide a historical, scientific, and regulatory 

perspective for this particular project. 

3.2.6 A6 - Project/Task Description 

Provide a summary of all work to be performed, products to be produced, and the 

schedule for implementation. Provide maps or tables that show or state the geographic locations 

of field tasks. This discussion need not be lengthy or overly detailed, but should give an overall 

picture of how the project will resolve the problem or question described in A5. 

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EPA QA/R-5 14 March 2001 
3.2.7 A7 - Quality Objectives and Criteria 

Discuss the quality objectives for the project and the performance criteria to achieve those 

objectives. EPA requires the use of a systematic planning process to define these quality 

objectives and performance criteria. 

3.2.8 A8 - Special Training/Certification 

Identify and describe any specialized training or certifications needed by personnel in order 

to successfully complete the project or task. Discuss how such training will be provided and how 

the necessary skills will be assured and documented. 

3.2.9 A9 - Documents and Records 

Describe the process and responsibilities for ensuring the appropriate project personnel 

have the most current approved version of the QA Project Plan, including version control, 

updates, distribution, and disposition. 

Itemize the information and records which must be included in the data report package 

and specify the reporting format for hard copy and any electronic forms. Records can include raw 

data, data from other sources such as data bases or literature, field logs, sample preparation and 

analysis logs, instrument printouts, model input and output files, and results of calibration and QC 

checks. 

Identify any other records and documents applicable to the project that will be produced, 

such as audit reports, interim progress reports, and final reports. Specify the level of detail of the 

field sampling, laboratory analysis, literature or data base data collection, or modeling documents 

or records needed to provide a complete description of any difficulties encountered. 

Specify or reference all applicable requirements for the final disposition of records and 

documents, including location and length of retention period. 

3.3 GROUP B: DATA GENERATION AND ACQUISITION 

The elements in this group (Table 2) address all aspects of data generation and acquisition 

to ensure that appropriate methods for sampling, measurement and analysis, data collection or 

generation, data handling, and QC activities are employed and documented. The following QA 

Project Plan elements describe the requirements related to the actual methods or methodology to 

be used for the: 

C collection, handling, and analysis of samples; 

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EPA QA/R-5 15 March 2001 
C data obtained from other sources (e.g., contained in a computer data base from 

previous sampling activities, compiled from surveys, taken from the literature); and 

C the management (i.e., compiling, handling) of the data. 

The methods described in these elements should have been summarized earlier in element A6. The 

purpose here is to provide detailed information on the methods. If the designated methods are 

well documented and are readily available to all project participants, citations are adequate; 

otherwise, detailed copies of the methods and/or SOPs must accompany the QA Project Plan 

either in the text or as attachments. 

Table 2. Group B: Data Generation and 

Acquisition Elements 

B1 Sampling Process Design (Experimental Design) 

B2 Sampling Methods 

B3 Sample Handling and Custody 

B4 Analytical Methods 

B5 Quality Control 

B6 Instrument/Equipment Testing, Inspection, and Maintenance 

B7 Instrument/Equipment Calibration and Frequency 

B8 Inspection/Acceptance of Supplies and Consumables 

B9 Non-direct Measurements 

B10 Data Management 

3.3.1 B1- Sampling Process Design (Experimental Design) 

Describe the experimental data generation or data collection design for the project, 

including as appropriate: 

C the types and numbers of samples required, 

C the design of the sampling network, 

C the sampling locations and frequencies, 

C sample matrices, 

C measurement parameters of interest, and 

C the rationale for the design. 

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EPA QA/R-5 16 March 2001 
3.3.2 B2 - Sampling Methods 

Describe the procedures for collecting samples and identify the sampling methods and 

equipment, including any implementation requirements, sample preservation requirements, 

decontamination procedures, and materials needed for projects involving physical sampling. 

Where appropriate, identify sampling methods by number, date, and regulatory citation. If a 

method allows the user to select from various options, then the method citations should state 

exactly which options are being selected. Describe specific performance requirements for the 

method. For each sampling method, identify any support facilities needed. The discussion should 

also address what to do when a failure in the sampling or measurement system occurs, who is 

responsible for corrective action, and how the effectiveness of the corrective action shall be 

determined and documented. 

Describe the process for the preparation and decontamination of sampling equipment, 

including the disposal of decontamination by-products; the selection and preparation of sample 

containers, sample volumes, and preservation methods; and maximum holding times to sample 

extraction and/or analysis. 

3.3.3 B3 - Sample Handling and Custody 

Describe the requirements for sample handling and custody in the field, laboratory, and 

transport, taking into account the nature of the samples, the maximum allowable sample holding 

times before extraction or analysis, and available shipping options and schedules for projects 

involving physical sampling. Sample handling includes packaging, shipment from the site, and 

storage at the laboratory. Examples of sample labels, custody forms, and sample custody logs 

should be included. 

3.3.4 B4 - Analytical Methods 

Identify the analytical methods and equipment required, including sub-sampling or 

extraction methods, laboratory decontamination procedures and materials (such as in the case of 

hazardous or radioactive samples), waste disposal requirements (if any), and any specific 

performance requirements for the method. Where appropriate, analytical methods may be 

identified by number, date, and regulatory citation. Address what to do when a failure in the 

analytical system occurs, who is responsible for corrective action, and how the effectiveness of the 

corrective action shall be determined and documented. Specify the laboratory turnaround time 

needed, if important to the project schedule. 

List any method performance standards. If a method allows the user to select from 

various options, then the method citations should state exactly which options are being selected. 

For non-standard method applications, such as for unusual sample matrices and situations, 

appropriate method performance study information is needed to confirm the performance of the 

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EPA QA/R-5 17 March 2001 
method for the particular matrix. If previous performance studies are not available, they must be 

developed during the project and included as part of the project results. 

3.3.5 B5 - Quality Control 

Identify QC activities needed for each sampling, analysis, or measurement technique. For 

each required QC activity, list the associated method or procedure, acceptance criteria, and 

corrective action. Because standard methods are often vague or incomplete in specifying QC 

requirements, simply relying on the cited method to provide this information is usually insufficient. 

QC activities for the field and the laboratory include, but are not limited to, the use of blanks, 

duplicates, matrix spikes, laboratory control samples, surrogates, or second column confirmation. 

State the frequency of analysis for each type of QC activity, and the spike compounds sources and 

levels. State or reference the required control limits for each QC activity and corrective action 

required when control limits are exceeded and how the effectiveness of the corrective action shall 

be determined and documented. 

Describe or reference the procedures to be used to calculate applicable statistics (e.g., 

precision and bias). Copies of the formulas are acceptable as long as the accompanying narrative 

or explanation specifies clearly how the calculations will address potentially difficult situations 

such as missing data values, “less than” or “greater than” values, and other common data 

qualifiers. 

3.3.6 B6 - Instrument/Equipment Testing, Inspection, and Maintenance 

Describe how inspections and acceptance testing of instruments, equipment, and their 

components affecting quality will be performed and documented to assure their intended use as 

specified. Identify and discuss the procedure by which final acceptance will be performed by 

independent personnel (e.g., personnel other than those performing the work) and/or by the EPA 

project manager. Describe how deficiencies are to be resolved, when re-inspection will be 

performed, and how the effectiveness of the corrective action shall be determined and 

documented. 

Describe or reference how periodic preventive and corrective maintenance of 

measurement or test equipment or other systems and their components affecting quality shall be 

performed to ensure availability and satisfactory performance of the systems. Identify the 

equipment and/or systems requiring periodic maintenance. Discuss how the availability of critical 

spare parts, identified in the operating guidance and/or design specifications of the systems, will 

be assured and maintained. 

3.3.7 B7 - Instrument/Equipment Calibration and Frequency 

Identify all tools, gauges, instruments, and other sampling, measuring, and test equipment 

used for data generation or collection activities affecting quality that must be controlled and, at 

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EPA QA/R-5 18 March 2001 
specified periods, calibrated to maintain performance within specified limits. Describe or 

reference how calibration will be conducted using certified equipment and/or standards with 

known valid relationships to nationally recognized performance standards. If no such nationally 

recognized standards exist, document the basis for the calibration. Identify the certified 

equipment and/or standards used for calibration. Indicate how records of calibration shall be 

maintained and be traceable to the instrument. 

3.3.8 B8 - Inspection/Acceptance of Supplies and Consumables 

Describe how and by whom supplies and consumables (e.g., standard materials and 

solutions, sample bottles, calibration gases, reagents, hoses, deionized water, potable water, 

electronic data storage media) shall be inspected and accepted for use in the project. State 

acceptance criteria for such supplies and consumables. 

3.3.9 B9 - Non-direct Measurements 

Identify any types of data needed for project implementation or decision making that are 

obtained from non-measurement sources such as computer data bases, programs, literature files, 

and historical data bases. Describe the intended use of the data. Define the acceptance criteria 

for the use of such data in the project and specify any limitations on the use of the data. 

3.3.10 B10 - Data Management 

Describe the project data management process, tracing the path of the data from their 

generation to their final use or storage (e.g., the field, the office, the laboratory). Describe or 

reference the standard record-keeping procedures, document control system, and the approach 

used for data storage and retrieval on electronic media. Discuss the control mechanism for 

detecting and correcting errors and for preventing loss of data during data reduction, data 

reporting, and data entry to forms, reports, and databases. Provide examples of any forms or 

checklists to be used. 

Identify and describe all data handling equipment and procedures to process, compile, and 

analyze the data. This includes procedures for addressing data generated as part of the project as 

well as data from other sources. Include any required computer hardware and software and 

address any specific performance requirements for the hardware/software configuration used. 

Describe the procedures that will be followed to demonstrate acceptability of the 

hardware/software configuration required. Describe the process for assuring that applicable 

information resource management requirements are satisfied. 

Describe the process for assuring that applicable Agency information resource 

management requirements (EPA Directive 2100) are satisfied (EPA QA Project Plans only). If 

other Agency data management requirements are applicable, such as the Chemical Abstract 

Service Registry Number Data Standard (EPA Order 2180.1), Data Standards for the Electronic 

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EPA QA/R-5 19 March 2001 
Transmission of Laboratory Measurement Results (EPA Order 2180.2), the Minimum Set of Data 

Elements for Ground-Water Quality (EPA Order 7500.1A), or new data standards as they are 

issued by EPA, discuss how these requirements are addressed. 

3.4 GROUP C: ASSESSMENT AND OVERSIGHT 

The elements in this group (Table 3) address the activities for assessing the effectiveness 

of project implementation and associated QA and QC activities. The purpose of assessment is to 

ensure that the QA Project Plan is implemented as prescribed. 

Table 3. Group C: Assessment and 

Oversight Elements 

C1 Assessments and Response Actions 

C2 Reports to Management 

3.4.1 C1 - Assessments and Response Actions 

Describe each assessment to be used in the project including the frequency and type. 

Assessments include, but are not limited to, surveillance, management systems reviews, readiness 

reviews, technical systems audits, performance evaluations, audits of data quality, and data quality 

assessments. Discuss the information expected and the success criteria (i.e., goals, performance 

objectives, acceptance criteria specifications, etc.) for each assessment proposed. List the 

approximate schedule of assessment activities. For any planned self-assessments (utilizing 

personnel from within the project groups), identify potential participants and their exact 

relationship within the project organization. For independent assessments, identify the 

organization and person(s) that shall perform the assessments if this information is available. 

Describe how and to whom the results of each assessment shall be reported. 

Define the scope of authority of the assessors, including stop work orders, and when 

assessors are authorized to act. 

Discuss how response actions to assessment findings, including corrective actions for 

deficiencies and other non-conforming conditions, are to be addressed and by whom. Include 

details on how the corrective actions will be verified and documented. 

3.4.2 C2 - Reports to Management 

Identify the frequency and distribution of reports issued to inform management (EPA or 

otherwise) of the project status; for examples, reports on the results of performance evaluations 

and system audits; results of periodic data quality assessments; and significant quality assurance 

Final 

EPA QA/R-5 20 March 2001 
problems and recommended solutions. Identify the preparer and the recipients of the reports, and 

any specific actions recipients are expected to take as a result of the reports. 

3.5 GROUP D: DATA VALIDATION AND USABILITY 

The elements in this group (Table 4) address the QA activities that occur after the data 

collection phase of the project is completed. Implementation of these elements determines 

whether or not the data conform to the specified criteria, thus satisfying the project objectives. 

Table 4. Group D: Data Validation 

and Usability Elements 

D1 Data Review, Verification, and Validation 

D2 Verification and Validation Methods 

D3 Reconciliation with User Requirements 

3.5.1 D1 - Data Review, Verification, and Validation 

State the criteria used to review and validate -- that is, accept, reject, or qualify -- data, in 

an objective and consistent manner. 

3.5.2 D2 - Verification and Validation Methods 

Describe the process to be used for verifying and validating data, including the chain-ofcustody for data throughout the life of the project or task. Discuss how issues shall be resolved 

and the authorities for resolving such issues. Describe how the results are conveyed to data users. 

Precisely define and interpret how validation issues differ from verification issues for this project. 

Provide examples of any forms or checklists to be used. Identify any project-specific calculations 

required. 

3.5.3 D3 - Reconciliation with User Requirements 

Describe how the results obtained from the project or task will be reconciled with the 

requirements defined by the data user or decision maker. Outline the proposed methods to 

analyze the data and determine possible anomalies or departures from assumptions established in 

the planning phase of data collection. Describe how reconciliation with user requirements will be 

documented, issues will be resolved, and how limitations on the use of the data will be reported to 

decision makers. 

Final 

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Final 

EPA QA/R-5 22 March 2001 
REFERENCES

40 CFR 30, Code of Federal Regulations, “Grants and Agreements With Institutions of Higher 

Education, Hospitals, and Other Non-Profit Organizations.” 

40 CFR 31, Code of Federal Regulations, “Uniform Administrative Requirements for Grants and 

Cooperative Agreement to State and Local Governments.” 

40 CFR 35, Code of Federal Regulations, “State and Local Assistance.” 

48 CFR 46, Code of Federal Regulations, “Federal Acquisition Regulations.” 

ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental 

Data Collection and Environmental Technology Programs, American National Standard, 

January 1995. 

EPA Directive 2100 (1998), Information Resources Management Policy Manual, U.S. 

Environmental Protection Agency, Washington, DC. 

EPA Order 2180.1 (June 1987), Chemical Abstract Service Registry Number Data Standard, 

U.S. Environmental Protection Agency, Washington, DC. 

EPA Order 2180.2 (December 1988), Data Standards for the Electronic Transmission of 

Laboratory Measurement Results, U.S. Environmental Protection Agency, Washington, 

DC. 

EPA Order 5360 A1 (May 2000). EPA Quality Manual for Environmental Programs, U.S. 

Environmental Protection Agency, Washington, DC. 

EPA Order 5360.1 A2 (May 2000), Policy and Program Requirements for the Mandatory 

Agency-wide Quality System, U.S. Environmental Protection Agency, Washington, DC. 

EPA Order 7500.1A (October 1992), Minimum Set of Data Elements for Ground-Water Quality, 

U.S. Environmental Protection Agency, Washington, DC. 

U.S. Environmental Protection Agency, 2001. EPA Requirements for Quality Management 

Plans (QA/R-2), EPA/240/B-01/002, Office of Environmental Information. 

U.S. Environmental Protection Agency, 2000a. Guidance for Data Quality Assessment: 

Practical Methods for Data Analysis (QA/G-9), EPA/600/R-96/084, Office of 

Environmental Information. 

Final 

EPA QA/R-5 23 March 2001 
U.S. Environmental Protection Agency, 2000b. Guidance for the Data Quality Objectives 

Process (QA/G-4), EPA/600/R-96/055, Office of Environmental Information. 

U.S. Environmental Protection Agency, 1998. Guidance for Quality Assurance Project Plans 

(QA/G-5), EPA/600/R-98/018, Office of Research and Development. 

U.S. Environmental Protection Agency, 1995. Guidance for the Preparation of Standard 

Operating Procedures (SOPs) for Quality-Related Documents (QA/G-6), EPA/600/R96/027, Office of Research and Development. 

U.S. Environmental Protection Agency, 1980. Interim Guidelines and Specifications for 

Preparing Quality Assurance Project Plans, QAMS-005/80, Office of Research and 

Development. 

Final 

EPA QA/R-5 24 March 2001 
APPENDIX A 

CROSSWALKS AMONG QUALITY ASSURANCE DOCUMENTS 

A.1 BACKGROUND 

This appendix contains crosswalks between this document and other QA planning 

documents. The first crosswalk compares this requirements document with its predecessor 

document, QAMS 005/80, Interim Guidelines and Specifications for Preparing Quality 

Assurance Project Plans (EPA 1980). The second crosswalk compares the elements of the QA 

Project Plan defined in this document with the steps defined in Guidance for the Data Quality 

Objectives Process (QA/G-4) (EPA 2000b), the Agency’s preferred systematic planning process 

for environmental decision making. This crosswalk is provided to assist the reader in determining 

how the outputs from the DQO Process can be integrated into a QA Project Plan. 

A.2 CROSSWALK BETWEEN EPA QA/R-5 AND QAMS-005/80 

QAMS-005/80 ELEMENTS QA/R-5 ELEMENTS 

1.0 Title Page with Provision for 

Approval Signatures 

A1 Title and Approval Sheet 

2.0 Table of Contents A2 Table of Contents 

3.0 Project Description A5 Problem Definition/Background 

A6 Project/Task Description 

4.0 Project Organization and 

Responsibility 

A3 Distribution List 

A4 Project/Task Organization 

A8 Special Training/Certification 

A9 Documents and Records 

5.0 QA Objectives for Measurement 

Data (PARCC) 

A7 Quality Objectives and Criteria 

6.0 Sampling Procedures B1 Sampling Process Design 

B2 Sampling Methods 

7.0 Sample Custody B3 Sample Handling and Custody 

8.0 Calibration Procedures and 

Frequency 

B7 Instrument/Equipment Calibration and 

Frequency 

Final 

EPA QA/R-5 A-1 March 2001 
QAMS-005/80 ELEMENTS QA/R-5 ELEMENTS 

9.0 Analytical Procedures B4 Analytical Methods 

10.0 Data Reduction, Validation, and 

Reporting 

D1 Data Review, Verification, and 

Validation 

D2 Verification and Validation Methods 

B9 Non-direct Measurements 

B10 Data Management 

11.0 Internal Quality Control Checks 

and Frequency 

B5 Quality Control 

12.0 Performance and Systems C1 Assessments and Response Actions 

13.0 Preventive Maintenance B6 Instrument/Equipment Testing, 

Inspection, and Maintenance 

14.0 Specific Routine Procedures Measurement Parameters Involved D3 Reconciliation with User Requirements 

15.0 Corrective Action C1 Assessments and Response Actions 

16.0 QA Reports to Management C2 Reports to Management 

Final 

EPA QA/R-5 A-2 March 2001 
A.3 CROSSWALK BETWEEN THE DQO PROCESS AND THE QA PROJECT PLAN

Elements Requirements DQO Overlap 

PROJECT MANAGEMENT 

A1 Title and Approval Sheet Title and approval sheet. N/A 

A2 Table of Contents Document control format. N/A 

A3 Distribution List Distribution list for the QA Project Plan 

revisions and final guidance. 

Step 1: State the Problem 

A4 Project/Task 

Organization 

Identify individuals or organizations 

participating in the project and discuss their 

roles, responsibilities and organization. 

Step 1: State the Problem 

A5 Problem Definition/ 

Background 

1) State the specific problem to be solved or 

the decision to be made. 

2) Identify the decision maker and the principal 

customer for the results. 

Step 1: State the Problem 

Step 2: Identify the Decision 

A6 Project/Task Description 1) Hypothesis test, 2) expected measurements, 

3) ARARs or other appropriate standards, 4) 

assessment tools (technical audits), 5) work 

schedule and required reports. 

Step 1: State the Problem 

Step 2: Identify the Decision 

Step 3: Identify the Inputs to the Decision 

Step 6: Specify Limits on Decision Errors 

A7 Quality Objectives and 

Criteria 

Decision(s), population parameter of interest, 

action level, summary statistics and acceptable 

limits on decision errors. Also, scope of the 

project (domain or geographical locale). 

Step 4: Define the Boundaries 

Step 5: Develop a Decision Rule 

Step 6: Specify Limits on Decision Errors 

A8 Special Training/ 

Certification 

Identify special training that personnel will 

need. 

N/A 

A9 Documents and Records Itemize the information and records that must 

be included in a data report package, including 

report format and requirements for storage, 

etc. 

Step 3: Identify the Inputs to the Decision 

Step 7: Optimize the Design for Obtaining Data 

Final 

EPA QA/R-5 A-3 March 2001 
Elements Requirements DQO Overlap 

DATA GENERATION AND ACQUISITION 

B1 Sampling Process Design 

(Experimental Design) 

Outline the experimental design, including 

sampling design and rationale, sampling 

frequencies, matrices, and measurement 

parameter of interest. 

Step 5: Develop a Decision Rule 

Step 7: Optimize the Design for Obtaining Data 

B2 Sampling Methods Sample collection method and approach. Step 7: Optimize the Design for Obtaining Data 

B3 Sample Handling and 

Custody 

Describe the provisions for sample labeling, 

shipment, chain-of-custody forms, procedures 

for transferring and maintaining custody of 

samples. 

N/A 

B4 Analytical Methods Identify analytical method(s) and equipment 

for the study, including method performance 

requirements. 

Step 3: Identify the Inputs to the Decision 

Step 7: Optimize the Design for Obtaining Data 

B5 Quality Control Describe quality control procedures that 

should be associated with each sampling and 

measurement technique. List required checks 

and corrective action procedures. 

Step 3: Identify the Inputs to the Decision 

B6 Instrument/Equipment 

Testing, Inspection, and 

Maintenance 

Discuss how inspection and acceptance testing, 

including the use of QC samples, must be 

performed to ensure their intended use as 

specified by the design. 

Step 3: Identify the Inputs to the Decision 

B7 Instrument/Equipment 

Calibration and 

Frequency 

Identify tools, gauges and instruments, and 

other sampling or measurement devices that 

need calibration. Describe how the calibration 

should be done. 

Step 3: Identify the Inputs to the Decision 

B8 Inspection/Acceptance of 

Supplies and 

Consumables 

Define how and by whom the sampling 

supplies and other consumables will be 

accepted for use in the project. 

N/A 

Final 

EPA QA/R-5 A-4 March 2001 
Elements Requirements DQO Overlap 

B9 Non-direct 

Measurements 

Define the criteria for the use of nonmeasurement data, such as data that come 

from databases or literature. 

Step 1: State the Problem 

Step 7: Optimize the Design for Obtaining Data 

B10 Data Management Outline the data management scheme including 

the path and storage of the data and the data 

record-keeping system. Identify all data 

handling equipment and procedures that will be 

used to process, compile, and analyze the data. 

Step 3: Identify the Inputs to the Decision 

Step 7: Optimize the Design for Obtaining Data 

ASSESSMENT AND OVERSIGHT 

C1 Assessments and 

Response Actions 

Describe the assessment activities needed for 

this project. 

Step 7: Optimize the Design for Obtaining Data 

C2 Reports to Management Identify the frequency, content, and 

distribution of reports issued to keep 

management informed. 

N/A 

DATA VALIDATION AND USABILITY 

D1 Data Review, 

Verification, and 

Validation 

State the criteria used to accept or reject the 

data based on quality. 

Step 7: Optimize the Design for Obtaining Data 

D2 Verification and 

Validation Methods 

Describe the process to be used for verifying 

and validating data, including the chain-ofcustody for data throughout the lifetime of the 

project. 

Step 3: Identify the Inputs to the Decision 

D3 Reconciliation With User 

Requirements 

Describe how results will be evaluated to 

determine if performance criteria have been 

satisfied. 

Step 7: Optimize the Design for Obtaining Data 

Final 

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Final 

EPA QA/R-5 A-6 March 2001 
APPENDIX B 

TERMS AND DEFINITIONS 

assessment - the evaluation process used to measure the performance or effectiveness of a system 

and its elements. As used here, assessment is an all-inclusive term used to denote any of the 

following: audit, performance evaluation, management systems review, peer review, inspection, or 

surveillance. 

audit (quality) - a systematic and independent examination to determine whether quality 

activities and related results comply with planned arrangements and whether these arrangements 

are implemented effectively and are suitable to achieve objectives. 

calibration - comparison of a measurement standard, instrument, or item with a standard or 

instrument of higher accuracy to detect and quantify inaccuracies and to report or eliminate those 

inaccuracies by adjustments. 

chain-of-custody - an unbroken trail of accountability that ensures the physical security of 

samples, data, and records. 

contractor - any organization or individual that contracts to furnish services or items or perform 

work; a supplier in a contractual situation. 

data quality assessment - a statistical and scientific evaluation of the data set to determine the 

validity and performance of the data collection design and statistical test, and to determine the 

adequacy of the data set for its intended use. 

data usability - the process of ensuring or determining whether the quality of the data produced 

meets the intended use of the data. 

design - specifications, drawings, design criteria, and performance requirements. Also the result 

of deliberate planning, analysis, mathematical manipulations, and design processes. 

environmental conditions - the description of a physical medium (e.g., air, water, soil, sediment) 

or biological system expressed in terms of its physical, chemical, radiological, or biological 

characteristics. 

environmental data - any measurements or information that describe environmental processes, 

location, or conditions; ecological or health effects and consequences; or the performance of 

environmental technology. For EPA, environmental data include information collected directly 

from measurements, produced from models, and compiled from other sources such as data bases 

or the literature. 

Final 

EPA QA/R-5 B-1 March 2001 
environmental data operations - work performed to obtain, use, or report information 

pertaining to environmental processes and conditions. 

environmental processes - manufactured or natural processes that produce discharges to or that 

impact the ambient environment. 

environmental programs - work or activities involving the environment, including but not 

limited to: characterization of environmental processes and conditions; environmental monitoring; 

environmental research and development; the design, construction, and operation of 

environmental technologies; and laboratory operations on environmental samples. 

environmental technology - an all-inclusive term used to describe pollution control devices and 

systems, waste treatment processes and storage facilities, and site remediation technologies and 

their components that may be utilized to remove pollutants or contaminants from or prevent them 

from entering the environment. Examples include wet scrubbers (air), soil washing (soil), 

granulated activated carbon unit (water), and filtration (air, water). Usually, this term will apply 

to hardware-based systems; however, it will also apply to methods or techniques used for 

pollution prevention, pollutant reduction, or containment of contamination to prevent further 

movement of the contaminants, such as capping, solidification or vitrification, and biological 

treatment. 

financial assistance - the process by which funds are provided by one organization (usually 

government) to another organization for the purpose of performing work or furnishing services or 

items. Financial assistance mechanisms include grants, cooperative agreements, performance 

partnership agreements, and government interagency agreements. 

graded approach - the process of basing the level of application of managerial controls applied 

to an item or work according to the intended use of the results and the degree of confidence 

needed in the quality of the results. 

independent assessment - an assessment performed by a qualified individual, group, or 

organization that is not a part of the organization directly performing and accountable for the 

work being assessed. 

information resources management - the planning, budgeting, organizing, directing, training 

and controls associated with information. The term encompasses both information itself and 

related resources such as personnel, equipment, funds and technology. 

inspection - an activity such as measuring, examining, testing, or gauging one or more 

characteristics of an entity and comparing the results with specified requirements in order to 

establish whether conformance is achieved for each characteristic. 

Final 

EPA QA/R-5 B-2 March 2001 
management system - a structured, non-technical system describing the policies, objectives, 

principles, organizational authority, responsibilities, accountability, and implementation plan of an 

organization for conducting work and producing items and services. 

method - a body of procedures and techniques for performing an activity (e.g., sampling, 

modeling, chemical analysis, quantification) systematically presented in the order in which they are 

to be executed. 

participant - when used in the context of environmental programs, an organization, group, or 

individual that takes part in the planning and design process and provides special knowledge or 

skills to enable the planning and design process to meet its objective. 

performance evaluation - a type of audit in which the quantitative data generated in a 

measurement system are obtained independently and compared with routinely obtained data to 

evaluate the proficiency of an analyst or laboratory. 

quality - the totality of features and characteristics of a product or service that bear on its ability 

to meet the stated or implied needs and expectations of the user. 

quality assurance (QA) - an integrated system of management activities involving planning, 

implementation, documentation, assessment, reporting, and quality improvement to ensure that a 

process, item, or service is of the type and quality needed and expected by the client. 

quality assurance manager - the individual designated as the principal manager within the 

organization having management oversight and responsibilities for planning, documenting, 

coordinating, and assessing the effectiveness of the quality system for the organization. 

quality assurance project plan - a document describing in comprehensive detail the necessary 

QA, QC, and other technical activities that must be implemented to ensure that the results of the 

work performed will satisfy the stated performance criteria. 

quality control (QC) - the overall system of technical activities that measures the attributes and 

performance of a process, item, or service against defined standards to verify that they meet the 

stated requirements established by the customer; operational techniques and activities that are 

used to fulfill requirements for quality. 

quality management - that aspect of the overall management system of the organization that 

determines and implements the quality policy. Quality management includes strategic planning, 

allocation of resources, and other systematic activities (e.g., planning, implementation, 

documentation, and assessment) pertaining to the quality system. 

quality management plan - a document that describes a quality system in terms of the 

organizational structure, policy and procedures, functional responsibilities of management and 

Final 

EPA QA/R-5 B-3 March 2001 
staff, lines of authority, and required interfaces for those planning, implementing, documenting, 

and assessing all activities conducted. 

quality system - a structured and documented management system describing the policies, 

objectives, principles, organizational authority, responsibilities, accountability, and implementation 

plan of an organization for ensuring quality in its work processes, products (items), and services. 

The quality system provides the framework for planning, implementing, documenting, and 

assessing work performed by the organization and for carrying out required QA and QC activities. 

readiness review - a systematic, documented review of the readiness for the start-up or continued 

use of a facility, process, or activity. Readiness reviews are typically conducted before proceeding 

beyond project milestones and prior to initiation of a major phase of work. 

record - a completed document that provides objective evidence of an item or process. Records 

may include photographs, drawings, magnetic tape, and other data recording media. 

specification - a document stating requirements and which refers to or includes drawings or other 

relevant documents. Specifications should indicate the means and the criteria for determining 

conformance. 

supplier - any individual or organization furnishing items or services or performing work 

according to a procurement document or financial assistance agreement. This is an all-inclusive 

term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator, or 

consultant. 

surveillance (quality) - continual or frequent monitoring and verification of the status of an 

entity and the analysis of records to ensure that specified requirements are being fulfilled. 

technical systems audit (TSA) - a thorough, systematic, on-site, qualitative audit of facilities, 

equipment, personnel, training, procedures, record keeping, data validation, data management, 

and reporting aspects of a system. 

validation - confirmation by examination and provision of objective evidence that the particular 

requirements for a specific intended use are fulfilled. In design and development, validation 

concerns the process of examining a product or result to determine conformance to user needs. 

verification - confirmation by examination and provision of objective evidence that specified 

requirements have been fulfilled. In design and development, verification concerns the process of 

examining a result of a given activity to determine conformance to the stated requirements for that 

activity. 

Final 

EPA QA/R-5 B-4 March 2001 
APPENDIX A – BIODEGRADATION SUPPLEMENTAL ENVIRONMENTAL PROJECT

ATTACHMENT F: 

Test Substance Certificate of Analysis 

DuPont Test Substance Identification: H-XXXXX 

Generic Name : Fluorotelomer-based 

Test Substance Properties 

• pH -1 -1 

• Density (g•mL ) g•mL

• Weight percent solids (wt% solids) wt% 

• Weight percent active ingredient (wt% a.i.) wt% 

• Weight percent Fluorine (%F) %F 

• Number Average Molecular Weight (Mn) 

• Weight Average Molecular Weight (Mw) 

• Appearance 

Test Substance Composition 

CAS# wt% 

Test Substance Trace Chemical Impurities 

Name CAS Number ng•mg-1* nmol•mg-1 * 

6-2 Fluorotelomer Alcohol 647-42-7 

8-2 Fluorotelomer Alcohol 678-39-7 

10-2 Fluorotelomer Alcohol 865-86-1 

8-2 Fluorotelomer ethene 21652-58-4 

8-2 Fluorotelomer Iodide 2043-53-0 

10-2 Fluorotelomer Iodide 2043-54-1 

Perfluorooctyl Iodide 507-63-1 

Perfluorodecyl Iodide 423-62-1 

8-2 Fluorotelomer acrylate 

(only for polyacrylates) 

27905-45-9 

1
8-2 Fluorotelomer saturated 

Acid 

27854-31-5 

8-2-Fluorotelomer 

unsaturated Acid 

70887-84-2 

Perfluorooctanoic Acid 335-67-1 

2-H Perfluorooctanoic Acid 142821-03-2 

Perfluorononanoic Acid 375-95-1 

Perfluorodecanoic Acid 335-76-2 

Perfluoroundecanoic Acid 2058-94-8 

7-3 Fluorotelomer Acid 812-70-4 

7-2 Fluorotelomer iso-ethanol 24015-83-6 

7-2 Fluorotelomer 

unsaturated Acid

 755-03-3 

7-3 Fluorotelomer 

unsaturated Amide 

56017-64-2 

PFOA telomer 8-2 ester 

Octanoic acid, 

pentadecafluoro-, 

3,3,4,4,5,5,6,6,7,7,8,8,9,9,10, 

10,10-heptadecafluorodecyl 

ester 

MW 860 

NA 

* based on solids content

Storage Conditions for 1 year stability (temperature and lighting conditions) 

Sample Expiration Date : 

Prepared By : _______________________ Date: _________________ 

2
APPENDIX A – BIODEGRADATION SUPPLEMENTAL ENVIRONMENTAL PROJECT

ATTACHMENT G: 

List of Laboratories for Biodegradation and Characterization 

Biodegradation Laboratories 

Springborn Smithers Laboratories

Massachusetts Research Center

790 Main Street

Wareham, MA 02571

Phone (508) 295-2550

Fax (508) 295-8107

http://www.springbornsmithers.com/simltest.html

ABC Laboratories, Inc.

7200 E. ABC Lane

Columbia, Missouri 65202 USA

(573) 443 9000 Telephone

(573) 443 9033 Facsimile

http://www.abclabs.com/cd/fate/fate_biodeg_metabolism.HTM 

Wildlife International

8598 Commerce Drive, Easton, MD 21601

http://www.wildlifeinternational.com/biodeg.htm

Characterization & Analytical Support Laboratories 

Exygen Research

3058 Research Drive

State College, PA 16801

Toll Free : 866.533.0092

Telephone: 814.272.1039

Facsimile: 814.272.1019

Email: info@exygen.com <mailto:info@exygen.com> 

STL Denver

4955 Yarrow Street

Arvada, CO 80002

Phone: 303-736-0100

Fax: 303-431-7171

http://www.stl-inc.com/index.htm

Quest Pharmaceutical Services

3 Innovation Way, Suite 240

Newark, DE 19711

302-369-5601

302-369-5602

http://www.questpharm.com/
APPENDIX B 

 TO CONSENT AGREEMENT AND FINAL ORDER 

MICROSCALE CHEMISTRY AND GREEN CHEMISTRY 

FOR JUNIOR HIGH SCHOOLS AND HIGH SCOOLS IN 

 WOOD COUNTY, WEST VIRGINIA: 

SUPPLEMENTAL ENVIRONMENTAL PROJECT

Overview

This document describes the Micro-scale Chemistry and Green Chemistry Program that 

Respondent E.I. du Pont de Nemours and Company (“DuPont” or “the Company”) will 

implement in five junior high schools and three high schools in the public school system of 

Wood County, West Virginia. [Schools named in attachment 1 to this document.] The program

will be implemented as a Supplemental Environmental Project (“SEP”) pursuant to Section III of 

the Consent Agreement and Final Order (“CAFO”). This SEP is subject to the applicable terms 

and conditions specified in the CAFO and to the additional specifications set forth in this 

Appendix. The effective date of this SEP is the same as the effective date of the CAFO. 

The goals of this SEP are to (1) reduce the adverse impact to public health by minimizing 

the potential exposure to chemicals in schools, (2) reduce the adverse impact to the environment 

in and around Wood County, West Virginia by minimizing disposal of hazardous waste 

generated at schools and (3) enhance science safety in all of these schools (hereinafter referred to 

as “the SEP Goals.” 

The total cost of this SEP is one million two hundred fifty thousand dollars ($1,250,000). 

DuPont plans to engage Education Planning & Oversight, Dover, Delaware, (“EPO”) to 

lead the design and administration of this SEP and act as project manager. 

The implementation of this SEP will involve close coordination between EPO and the 

teachers and administrators in the participating schools. The Wood County school district may 

wish to modify certain aspects of this SEP in order to best accommodate local resources and 

objectives (if, for example, the district converts current junior high schools to grade 6-9 middle 

schools) but such modifications will always maintain the SEP Goals. 

Consequently, EPA and DuPont recognize and agree that this SEP will be implemented 

flexibly although remain consistent with the SEP Goals. DuPont may request adjustments of the

schedules and will inform EPA of SEP implementation in detailed progress reports. EPA and 

DuPont recognize that the schedules for implementation of each Program of this SEP set forth in 

the following work plan are good faith estimates that depend on, among other things, timely 

actions and responses by third parties in Wood County, WV and the participating schools, 

including administrators and teachers. 

1
2

DuPont agrees that the cost of EPO’s services in excess of $125,000 is NOT an eligible 

cost of the SEP. DuPont will compensate the participating school districts and their employees 

for the direct expenses they incur (including costs of substitute teachers to cover instructional 

time during teacher training periods) as a result of participating in SEP activities, and would not 

otherwise incur, and that this compensation will be an allowable cost of the SEP. 

It is understood that this SEP does not require DuPont to undertake any action that would 

render DuPont liable to any person for personal injury, property damage, economic loss or any 

other claim whatsoever. 

Work Plan and Schedule

Microscale Chemistry & Green Chemistry Program in Wood County, WV 

Microscale chemistry reduces risk by reducing exposure to chemicals. Microscale 

involves using very small, pre-measured quantities of chemicals when conducting experiments in 

the 7-12 science classroom. This approach is associated with pre-packaged consumable

materials for science education. The key feature of these materials is the use of nominal amounts 

of chemicals, often in pre-measured devices that allow a student to participate in a hands-on 

experiment without having large containers of excess chemicals being stored at the school. 

Green Chemistry reduces risk by reducing hazard. Green chemistry involves using safer 

chemicals in a process that is typically used in a student laboratory course. If a chemical process 

employs hazardous substances – for example, a toxin or dermal irritant – there is always possible 

danger even if the exposure to such substances is reduced by controlling the quantity of material 

used. Therefore, principles of green chemistry are used to find safer reactants to produce the 

same results. A common type of experiment in student labs is called a “clock reaction.” In such 

a reaction, a sudden color change occurs when the reaction is complete. The color change allows 

students to measure reaction time. Instead of using formaldehyde or bisulfites in such a reaction, 

student labs could use ordinary household materials such as hydrogen peroxide, iodine and 

vitamin C tablets.

Within ninety (90) days after the effective date of this SEP, EPO will meet with 

administrators from Wood County school district, provide an overview of the activities to be 

conducted under this SEP, obtain an indication of the willingness of each to participate in the 

micro-scale chemistry and green chemistry program. 

Year 1: Strategic Planning: EPO will review existing 7-12 science curricula in the 

school district and, in collaboration with the school district, EPO will assist in the development 

of a plan for implementation of instructional units, modules, and activities using pre-packaged 

(micro-scale and small scale) consumable materials, whether purchased from science materials 

vendors or refurbished through the school district’s Materials Center at the 7-12 levels in that 

district. 

 EPO will complete a review of the district’s 7-12 grade science curricula, including 

mapping district curricula to state standards. The school district will be asked to identify a 

Strategic Planning Leadership Team (SPLT) comprising five members representing school 
3

administrators (principals, science specialists, school board members), 7-12 grade teachers, and 

may include one scientist from local industry. 

SPLT will write a 5-year Strategic Plan encompassing the five elements of education 

enhancement: curriculum selection; teacher professional development; materials (storage, 

distribution, and refurbishment); assessment; and community and administrative support. 

Depending on availability, SPLT will either attend an NSRC (National Science Resources 

Center) Strategic Planning Institute or equivalent, or EPO will design a 3-4 day planning meeting 

during which SPLT will write a draft Strategic Plan. 

EPO anticipates that these strategic planning activities will require approximately six 

months to complete, depending in part on how quickly SPLT does its work. EPO will prepare a 

report for submission to EPA at the completion of the activities but no later than 12 months from 

the effective date of the CAFO. This report will include a summary of costs incurred by DuPont 

to date, a discussion of any problems or delays encountered in the program to date, and a 

projection of the expenditures for the remainder of the SEP based on experience to date.

Year 1: Curriculum Implementation: Within 6 months (extension may be liberally granted if 

the timing is affected by school calendar issues) following school district review and approval of 

the Strategic Plan, SPLT will establish key working committees, including a Curriculum 

Selection Committee, a Resource Center Committee, a Professional Development Committee, 

and an Assessment Committee. SPLT will recruit 2 Lead Teachers from each of the 5 junior 

high schools (grades 7-9), 2 from each of the high schools (grades 10-12), and 4 from the 1 

secondary school comprising grades 7-12 (2 from grades 7-9, 2 from grades 10-12) to implement 

the selected instructional units, modules, and activities using pre-packaged (micro-scale and 

small-scale) consumable materials.

Curriculum Selection Committee: EPO will conduct a Curriculum Selection 

workshop(s) to introduce the district to National Science Foundation-approved materials, 

including those approved for use at the middle school level (grades 6-8)─ FOSS (Full Option 

Science System), STC (Science and Technology for Children), and SEPUP (The Science 

Education for Public Understanding Program)─ and those approved for high school use in high 

school science classes where chemicals are used (which are set forth in Attachment 2 to this 

SEP). The Curriculum Selection Committee will select micro-scale chemistry materials for 

prospective implementation at each grade level. 

Resource Center Committee: The Resource Center Committee will identify a location 

for housing science materials and will develop processes for cataloguing, distributing, and 

refurbishing materials. The Committee will develop a budget for ongoing operation.

Professional Development Committee: During Years 1 and 2, outside consultants (i.e., 

science specialists from other school districts and/or kit vendors or materials publishers) will 

provide professional development for Lead Teachers. Following the initial phase of professional 

development, Lead Teachers and district science specialists will staff the Professional 

Development Committee and design and implement district-wide professional development. 

The Committee will be charged with writing a plan for professional development of all teachers 
4

of science in the district that enables them to use the materials provided under this SEP in 

furtherance of the SEP Goals. 

EPO anticipates that these planning activities will require approximately three months to 

complete, depending in part on how quickly the school district approves the Strategic Plan. EPO 

will prepare a report for submission to EPA at the completion of these planning activities but no 

later than 18 months from the effective date of the CAFO. This report will include a summary 

of costs incurred by DuPont to date, a discussion of any problems or delays encountered in the 

program to date, and a projection of expenditures for the remainder of the SEP based on 

experience to date.

Year 2: Pilot Implementation Year 

During the summer prior to implementation, Lead Teachers will complete structured 

professional development on (a) green chemistry concepts and (b) use of one micro-scale 

chemistry curricular unit or module at their grade level, to be provided. School principals will be 

strongly urged to attend these workshops. EPO will conduct a formative evaluation of the initial 

professional development workshops. The Resource Center will begin operation. 

At the beginning of the implementation year, Lead Teachers will pilot unit or module 1 at 

their respective school sites (as appropriate to curricular scope and sequence within grades 7-12). 

EPO will organize 2 peer observation and reflection meetings during the piloting phase. Vendor 

consultants will provide additional support during the pilot phase. EPO will write a summary 

report for the pilot. SPLT will review effectiveness of the plan. 

By year-end, SPLT will be succeeded by a permanent Steering Committee charged with 

ongoing implementation of the intervention and with securing funding for full implementation 

and ongoing operation. EPO will prepare a report for submission to EPA at the completion of 

these activities, which will include a summary of costs incurred by DuPont to date, a discussion 

of any problems or delays encountered in the program to date, and a projection of expenditures 

for the SEP based on experience to date. 

During the pilot implementation school year or the following summer, to prepare for full 

implementation of unit or module 1 and green chemistry principles in the following school year, 

Lead Teachers (with the support of outside consultants where necessary) will provide 

professional development on unit or module 1 and materials explaining green chemistry 

principles for all 7-12 teachers of science in the Wood County, WV school district. Lead 

Teachers will also complete 24 hours of structured professional development for nit or module 2 

and will pilot unit or module 2 during the upcoming school year. The Resource Center 

Committee will establish procedures for materials distribution district-wide prior to the full 

implementation year. Assessment Committee will write a plan for teacher professional 

development related to formative assessment of student learning during classroom 

implementation. The Lead Teachers, with the Curriculum Selection Committee, will assess the 

results of their piloting of unit or module 1 to inform grade level-wide professional development 

for unit or module 1. 
5

EPO will prepare a report for submission to EPA at the completion of these activities but 

not later than 3 years of the effective date of the CAFO, that will be the final SEP report for this 

SEP. This report shall include an accounting of all costs to DuPont for implementation of this 

SEP. 

Work Plan Management

Contact Persons: Within thirty (30) days of the effective date of this SEP, DuPont will

identify in writing to EPA the person who will represent DuPont for purposes of communications 

concerning any aspect of DuPont’s performance of this SEP, together with that contact person’s 

address, telephone number, and e-mail address. EPA’s contact person for this SEP is the contact 

point given for Reporting Requirements in the CAFO at Section V. All reports required by this 

SEP and all notices will be submitted to the EPA contact person at OPPTS. 

EPA Oversight of SEP Activities: To the extent practicable, EPO will give EPA’s 

designated contact person advance notice of meetings, training and other activities occurring 

under this SEP and EPA will be entitled to monitor or participate in any such meetings, training 

or other activities, provided that such activities do not interfere with the accomplishment of any 

SEP activity. EPA’s right to monitor activities under this SEP does not relieve DuPont of any 

obligation under the SEP or the CAFO.

Modification of Work Plan Tasks or Schedule If it appears to DuPont at any time 

during the implementation of this SEP, based on EPO’s reports or otherwise, that the SEP either 

cannot be completed in accordance with the schedule above or cannot be completed at a cost of 

$1,250,000, DuPont may propose modifications of this SEP to provide for a revised timetable for 

the SEP activities and/or for alternative SEP activities, provided that DuPont shall not be 

required to spend more than $1,250,000 in eligible costs under this SEP. Such a proposal will be 

in writing and will set forth the proposed modified schedule or alternative activities along with 

an explanation of the reasons why the original activities do not appear capable of completion 

within the original schedule and/or cost estimate. EPA shall consider the revised timetable or 

alternative SEP activities in a timely manner and must respond to DuPont’s proposal in order for 

the proposal to be approved. 

If EPA advises DuPont of such non-concurrence, the Parties will make a good-faith effort 

to identify alternative scheduling or alternative SEP activities. Such alternative SEP activities 

will conform to the SEP Goals. 
NATIONAL SCIENCE FOUNDATION-FUNDED SCIENCE INSTRUCTIONAL MATERIALS

Middle School (Grades 6-8) 

Instructional Materials Publisher 

FOSS (Full Option Science System) Delta Education 

STC (Science & Technology for Children) Carolina Biological 

SEPUP (Science Education for Public Understanding) Lab-Aids, Inc. 

High School (Grades 9-12) 

Instructional Materials Publisher 

Earth System Science in the Community It’s About Time Publishing 

(Earth Comm) 

Active Physics It’s About Time Publishing 

Chem Discovery Kendall/Hunt Publishing Co. 

Chemistry in the Community (ChemCom) W.H. Freeman & Co. 

Comprehensive Conceptual Curriculum for University of Dallas Physics 

Physics (C3

P) 

Hands-On Physics Concord Consortium 

Introductory Physical Science (IPS) Science Curriculum, Inc. 

Minds•On Physics Kendall/Hunt Publishing Co. 

Biology: A Community Context Glencoe/McGraw-Hill 

BSCS Biology: A Human Approach Kendall/Hunt Publishing Co. 

BSCS Biology: A Molecular Approach Glencoe/McGra-Hill 

BSCS Biology: An Ecological Approach Kendall/Hunt Publishing Co. 

Insights in Biology Kendall/Hunt Publishing Co. 

Ecology: A Systems Approach Kendall/Hunt Publishing Co. 

Global Lab Kendall/Hunt Publishing Co. 

Prime Science Kendall/Hunt Publishing Co. 

Science in a Technical World W.H. Freeman & Co. 

SEPUP: Issues, Evidence & You Lab-Aids, Inc. 

SEPUP: Science & Sustainability Lab-Aids, Inc. 

High School (Grades 9-12) [Under Development] 

Instructional Materials Publisher 

Astrobiology: The Search for Life It’s About Time 

BSCS Science: An Integrated Approach [BSCS] 

Exploring Earth Houghton Mifflin Company 

Foundation Science [EDC] 

Living By Chemistry [Lawrence Hall of Science] 

Science That Counts in the Workplace Kendall/Hunt Publishing Co. 

Voyages Through Time [SETI Institute] 
Wood County (WV) Junior High and High Schools 

Junior Highs (Grades 7 - 9) 

• Jackson Junior High School 

Address: 1601 34th Street 

Vienna, WV 26105 

Phone: 304-420-9551 

Fax: 304-295-9954 

Principal: Mr. Richard Summers 

E-mail: rpsummer@access.k12.wv.us

Enrollment: 587 

• Blennerhassett Junior High School 

Address: Route 4, Box 475A 

Parkersburg, WV 26101 

Phone: 304-863-3356 

Fax: 304-863-3357 

Principal: Mr. Steve Angel 

E-mail: sangel@access.k12.wv.us

Enrollment: 665 

• Edison Junior High School 

Address: 1201 Hillcrest Street 

Parkersburg, WV 26101 

Phone: 304-420-9525 

Fax: 304-420-9527 

Principal: Ms. Jean Mewshaw 

E-mail: jmewshaw@access.k12.wv.us

Enrollment: 724 

• Hamilton Junior High School 

Address: 3501 Cadillac Drive 

Parkersburg, WV 26104 

Phone: 304-420-9547 

Fax: 304-420-9567 

Principal: Mr. Mike Wells 

E-mail: gwells@access.k12.wv.us

Enrollment: 640 

• VanDevender Junior High School 

Address: 918 31st Street 

Parkersburg, WV 26104 

Phone: 304-420-9645 

Fax: 304-420-9647 

Principal: Mr. Steven Taylor 

E-mail: staylor@access.k12.wv.us

Enrollment: 380 
High Schools 

• Parkersburg High School (Grades 10 – 12) 

Address: 2101 Dudley Avenue 

Parkersburg, WV 26101 

Phone: 304-420-9595 

Fax: 304-420-9604 

Principal: Mr. Ralph Board 

E-mail: rsboard@access.k12.wv.us

Enrollment: 1,484 

• Parkersburg South High School (Grades 10 – 12) 

Address: 1511 Blizzard Drive 

Parkersburg, WV 26101 

Phone: 304-420-9610 

Fax: 304-420-9607 

Principal: Mr. Thomas Eschbacher 

E-mail: teschbac@access.k12.wv.us

Enrollment: 1,257 

• Williamstown High School (Grades 7 – 12) 

Address: 219 West 5th Street 

Williamstown, WV 26187 

Phone: 304-375-6151 

Fax: 304-375-6194 

Principal: Mr. Jack Mental 

E-mail: jmental@access.k12.wv.us

Enrollment: 662