1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 I. PRELIMINARY STATEMENT 1. EPA initiated this proceeding for the assessm ent 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 am ended by the Hazardous and Solid W a ste Am endm ents of 1984 (“HSW A ”), 42 U.S.C. §§ 6901 et seq ., and RCRA’s im plem enting regulations. 2. The parties are entering into this Consent Agreem ent to resolve the violations alleged in the First Am ended Com p laint, incorporated by ref e rence in its entirety into this docum ent, and the Second Com p laint, also incorporated by reference in its entirety into this docum ent, referred jointly in this Consent Agreem ent as the “Consolidated Action.” Respondent has entered into this Consent Agreem ent in order to resolve this m a tter, to avoid unnecessary business disruption, and to avoid the necessity of litigation. Nothing in this Consent Agreem ent should be taken as an adm i ssion of liability by Respondent or an adm i ssion as to any issue of fact or law raised by Com p lainant’s allegations in the Consolidated Action unless specif i cally stated below. 3. In the Consolidated Action, Com p lainant alleges that on three separate occasions as described in Counts I, II and IV of the First Am ended Com p laint and Second Com p laint, Respondent failed to com p ly with the requirem e nts of TSCA §§ 8(e) and 15, 15 U.S.C. §§ 2607(e) and 2614. As stated in its Answers to the First Am ended Com p laint and the Second Com p laint, which are incorporated in their entirety into this docum ent, Respondent denies these allegations. 4. The Com p lainant further alleges that, as described in Count III of the First Am ended Com p laint, Respondent violated RCRA § 3005( a), 42 U.S.C. § 6925(a), 40 C.F.R. § 270.30(h),

21 and W e st Virginia Hazardous W a ste Managem e ntRule § 33-20-11.1, and Part 1, Section I.7 of 2 the Corrective Action portion of DuPont’s hazardous waste perm it for the W a shington W o rks 3 Facility located in W a shington, W e st Virginia. As stated in its Answer to the First Am ended 4 Com p laint, which is incorporated by reference in its entirety into this docum ent, Respondent 5 denies this allegation. 6 5. This Consent Agreem ent and Final Order shall apply to, and be binding upon, 7 Respondent, its officers, directors, em ployees, successors and assigns, including, but not lim ited 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 Agreem ent 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 Agreem ent and waives its right to 13 appeal or to seek judicial review of the Final Order accom p anying this Consent Agreem ent. 14 8. W ithout adm itting the factual or legal allegations contained in the Consolidated 15 Action, except as stated in Paragraphs 6 and 7, above, Respondent consents to the term s of this 16 Consent Agreem ent and Final Order. 17 II. ADDITIONAL ALLEGED VIOLATIONS RESOLVED IN THIS 18 CONSENT AGREEMENT AND FINAL ORDER 19 20 1. The parties agree to settlem e nt of the f o llowing alleged violations bef o re the f iling of 21 a com p laint, 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.

31 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 3. Com p lainant alleges the following to form the factual basis for Count V:

a. Som e tim e in 2002, a third party perform e d testing that would detect levels of perfluorooctanoic acid (PFOA) in the blood serum of ten individuals living in W e st Virginia. Because only one of these ten individuals reporte dly had ever worked at DuPont’s W a shington W o rks Plant, this exposure to PFOA is considered to be non-occupational. b. At the tim e this com m unity serum sam p ling was perform e d, these ten individuals reportedly drank private well water located near one or m o re DuPont landf ills at which DuPont disposed am m onium perfluoroocta noate (APFO), also referred to by Com p lainant as perfluorooctanoic acid (PFOA). The ten indivi duals also lived in the vicinity of DuPont’s W a shington W o rks Plant in W e st Virginia.

c. DuPont represents to EPA that at no tim e before August 13, 2004, did DuPont, including any of its officers, em ployees, contractor s, and/or consultants, have knowledge of the 2002 blood serum sam p ling results for these non-occupational individuals. d. On Decem ber 20, 2004, DuPont subm itted to EPA the 2002 blood serum

sam p ling results for these non-occupational individuals. 4. Com p lainant alleges that Respondent should have im m e diately subm itted the 2002 blood serum sam p ling results for the ten non-occupational individuals, discussed in Paragraph II.3., above, when Respondent obtained this inform ation. 5. The following general factual allegations are relevant to, and incorporated in, Paragraphs II.6. – II.8., below:

41 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 a. In June 1991, EPA published the “TSCA Section 8(e) Reporting Guide” (1991 Reporting Guide), in which EPA provided reporti ng guidance for determ ining when to report signif i cant lethality observed in anim al studies. b. The 1991 Reporting Guide establishes specific num eric values that correspond to the f o llowing three toxicity categories: extrem ely toxic, highly toxic, and m oderately toxic. 6. Com p lainant alleges the following to form the factual basis for Count VI:

a. On or before July 11, 1997, DuPont perform e d an acute inhalation toxicity study for a perfluorinated chem ical substance, the identity of which has been claim e d as TSCA Confidential Business Inform ation by DuPont. b. This acute inhalation toxicity study was perform e d on m a le rats which were exposed to the test substance in an aerosol form . The study results were com p iled by DuPont in an internal docum ent described as Report No. HL-1997-00599.

c. On or before January 17, 2002, DuPont perform e d an acute inhalation toxicity study on m a le rats using the sam e perfluorinated chem ical substance in the sam e form and exposure pathway as was used in the test desc ribed in subparagraph b, above, but at different concentrations than were used in the 1997 study. d. W h ile DuPont subm itted Report No. HL-1997-00599 to EPA on Decem ber 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. Com p lainant alleges the following to form the factual basis for Count VII:

a. On or before July 11, 1997, DuPont perform e d an acute inhalation toxicity study on a perfluorinated chem ical substance, diffe rent from the chem ical substance at issue in

51 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Count VI, above, the identity of which has been claim e d as TSCA Confidential Business Inform ation by DuPont. b. This acute inhalation toxicity study was perform e d on m a le rats which were exposed to the test substance in an aerosol form . The study results were com p iled by DuPont in an internal docum ent described as Report No. HL-1997-00600.

c. DuPont subm itted Report No. HL-1997-00600 to EPA on Decem ber 7, 2004. 8. Com p lainant alleges the following to form the factual basis for Count VIII:

a. On or before August 29, 1997, DuPont perform e d an acute inhalation toxicity study on a perfluorinated chem ical substance, diffe rent from the chem ical substance at issue in Counts VI and VII, above, the identity of wh ich has been claim e d as TSCA Confidential Business Inform ation by DuPont. b. This acute inhalation toxicity study was perform e d on m a le rats which were exposed to the test substance in an aerosol form

. The study results were com p iled by DuPont in an internal docum ent described as Report No. HL-1997-00598.

c. DuPont subm itted Report No. HL-1997-00598 to EPA on Decem ber 7, 2004. 9. Under the 1991 Reporting Guide, where significant lethality occurs at a dose or concentration com p arable to an acute inhalation LC50 value of less than or equal to 0.5 m g /l, which EPA equates to 500 m g /m 3, the test substance is considered extrem ely toxic and the results of the study m u st be im m e diately reported to EPA.

a. Com p lainant 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 Supplem ent) discussed in Paragraph II.6., above, the test substance is extrem ely toxic under the

61 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 1991 Reporting Guide. Com p lainant alleges that Respondent should have im m e diately subm itted the results of this study to EPA under TSCA § 8(e) when DuPont obtained this inform ation. b. Com p lainant 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 Supplem ent) discussed in Paragraph II.7., above, the test substance is extrem ely toxic under the 1991 Reporting Guide. Com p lainant alleges that Respondent should have im m e diately subm itted the results of this study to EPA under TSCA § 8(e) when DuPont obtained this inform ation.

c. Com p lainant 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 Supplem ent) discussed in Paragraph II.8., above, the test substance is extrem ely toxic under the 1991 Reporting Guide. Com p lainant alleges that Respondent should have im m e diately subm itted the results of this study to EPA under TSCA § 8(e) when DuPont obtained this inform ation. 10. For the purpose of this proceeding, Respondent will not contest EPA’s jurisdiction to settle this action and to enter into this Consent Agreem ent and Final Order. 11. For the purpose of this proceeding, Respondent neither adm its 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 accom p anying this Consent Agreem ent.

71 III. TERMS OF SETTLEMENT 2 1. Pursuant to TSCA § 16 and RCRA § 3008, the nature, circum stances and extent of the 3 alleged violations, Respondent' s agreem ent to perform Supplem ental Environm ental Projects 4 (SEPs) and other relevant factors, Respondent agrees to payten million tw o hundred fifty 5 thousand dollars ($10,250,000) in accordance with the term s set forth below in order to settle 6 the allegations in the Consolidated Action and in Section II of this Consent Agreem ent. 7 2. W ithout adm itting any liability, Respondent enters into this Consent Agreem ent and 8 consents f o r the purposes of settlem e nt to ratif ication by the Environm ental Appeals Board of the 9 attached Final Order requiring the paym ent of the civil penalty cited in Paragraph III.1., above, 10 and the perform a nce of the SEPs in accordance with Section IV., below. 11 3. Not m o re than thirty (30) days following the effective date of the Final Order, 12 Respondent shall subm it either a cashier' s or certified check, payable to the order of the 13 "Treasurer, United States of Am erica," in the am ount of ten million tw o hundred fifty 14 thousand dollars ($ 10,250,000) , to: 15 EPA-W a shington 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 tw o 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:

81 Nam e of Beneficiary: EPA 2 Num b er of Account for deposit: 68010099 3 The Bank Holding Acct: T reas_NYC 4 The ABA routing Num b er: 021030004 5 4. Respondent shall provide, within fourteen (14) business days after m a king the 6 paym ent 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 Enforcem ent 10 1200 Pennsylvania Ave. N.W

. 11 W a shington, DC 20460

12 The check or wire transfer shall bear the case docket num ber. Interest and late charges shall be 13 assessed as specified in Paragraph IX.2. 14 5. The am ount 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 im plem ent the two SEPs described in detail in Appendices A and B 18 to this Consent Agreem ent, which have been approved by EPA and are attached hereto and 19 incorporated into this Consent Agreem ent by reference. Respondent shall im plem ent the two 20 SEPs in accordance with the respective provisions set forth in Appendices A and B. Appendix A 21 is entitled Fluorotelom er-based Product Biodegradation Testing

. The total cost of this SEP 22 (referred herein as “SEP A”) is set at five m illion dollars ($5,000,000). Appendix B is entitled 23 Microscale Chem istry and Green Chem istry Fo r Junior High Schools and High Schools in W ood

91 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 County, W e st Virginia

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

m illion two hundred fifty thousand dollars ($1,250,000). 2. SEP Com p letion: Both SEPs shall be com p leted within the tim ef ram e s established in Appendices A and B. Therefore, SEP A is to be com p leted within the tim efram e specified in, or extended in accordance with, Appendix A. SEP B is to be com p leted within the tim efram e specified in, or extended in accordance with, Appendix B. 3. In im plem enting 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 am ount indicated in Paragraph IV.1., above, for each SEP. Eligible SEP costs include the costs of planning and im plem enting the SEPs but do not include attorneys fees, the costs of em ployees perform i ng functions that are part of their regular duties, certain potential additional m a nagem e nt costs related to im plem entation 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 com p letion of the SEPs in accordance with the requirem e nts of this Consent Agreem ent, its Appendices and attachm e nts. “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 m a y use contractors or consultants in planning and im plem enting a SEP, Respondent always rem a ins responsible for the satisfactory com p letion of the SEP. In perform i ng activities under any of the SEPs, Respondent shall not be required to incur eligible costs in excess of the am ount indicated for that SEP in Paragraph IV.1., above.

101 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 5. W ith 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 Agreem ent, all cost inf o rm ation provided to EPA in connection with EPA’s approval of each SEP is com p lete and accurate and represents a fair estim ate of the costs necessary to im plem ent the SEPs; b. that, as of the date of executing this Consent Agreem ent, 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 re quired to perform or develop any of the SEPs by agreem ent, grant, or as injunctive relief awarded in any other action in any forum ;

c. that, as of the date of executing this Consent Agreem ent, each SEP is not a project that Respondent was planning or intending to perform or im plem ent other than in settlem e nt of the claim s resolved in this Consent Agreem ent; d. that, as of the date of executing this Consent Agreem ent, Respondent has not received, and is not negotiating to receive, credit for any of the SEPs in any other enforcem ent action; and

e. that Respondent will not receive any reim bursem e nt for any portion of any SEP. 6. SEP Com p letion Report: Not later than sixty (60) days after the date set for

com p letion of each SEP, or after Respondent has expended the am ount indicated for that SEP in Paragraph IV.1., above, on activities under the SEP, Respondent shall subm it a SEP Com p letion

111 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Report to the person indicated in Paragraph V.1. The SEP Com p letion Report shall contain the f o llowing inf o rm ation:

a. a detailed description of the SEP as im plem ented; b. a description of any problem s encountered in com p leting the SEP and the solutions thereto;

c. an item i zed list of all eligible SEP costs; d. certif ication that either the SEP has been f u lly im plem ented pursuant to the provisions of this Consent Agreem ent and the applicable Appendix or that Respondent has expended the am ount 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 environm ental and public health benef its resulting from im plem entation of the SEP (with a quantification of the benefits, if f easible). 7. EPA m a y, in its sole discretion, require any inform ation in addition to that described in the preceding Paragraph that is reasonably necessary in order to determ ine the adequacy of each SEP com p letion or eligibility of SEP costs, and Respondent shall provide such inform ation within thirty (30) days, unless the parties agree that additional tim e is necessary to provide the inf o rm ation. 8. W ithin sixty (60) days after receiving a SEP Com p letion Report, or if EPA does not receive a SEP Com p letion Report, within sixty (60) days after the date set for com p letion of the SEP or after Respondent has notified EPA that it has expended the am ount indicated for that SEP

121 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 in Paragraph IV.1., above, on activities under the SEP, EPA shall notify Respondent whether or not Respondent has satisfactorily com p leted that SEP. If EPA notifies Respondent that a SEP is not satisfactorily com p leted, Respondent shall ha ve ten (10) business days following receipt of such notice to object to the Agency’s determ ination. Respondent’s objection m u st be in writing and subm itted 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 agreem ent on changes necessary to the SEP, during which period Respondent shall not be deem ed to be in violation of this Consent Agreem ent. If the Parties cannot reach agreem ent on any such issue within this thirty (30) day period, EPA shall provide a written statem ent of its decision to Respondent, which decision shall be final. If the SEP has not been satisfactorily com p leted, stipulated penalties m a y be assessed under Section VII. of this Consent Agreem ent. If Respondent has satisfactorily com p leted all SEP activities described in the relevant Appendix but the am ount expended on perform a nce of the SEP is less than the am ount indicated for that SEP in Paragraph IV.1., above, then negotiations shall occur as provided under Section VI. of this Consent Agreem ent. 9. Each subm ission 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 statem ent, oral or written, in print, film , or other m e dia, m a de by Respondent m a king reference to the SEPs under this Consent Agreem ent shall include the following language: “This project was undertaken in connection with the settlem e nt of an

131 enforcem ent action taken by the U.S. Environm ental Protection Agency under the Toxic 2 Substances Control Act and the Resource Conservation and Recovery Act.” 3 V. REPORTING REQUIREMENTS 4 1. Respondent shall subm it the following reports: 5 a. W ithin 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 Agreem ent, until 7 term ination of this Consent Agreem ent pursuant to Paragraph IX.9., Respondent shall subm it in 8 writing to: 9 Mr. Tony Ellis 10 US EPA - Headquarters (2245A) 11 Office of Civil Enforcem ent 12 1200 Pennsylvania Ave., N.W

. 13 W a shington, DC 20460* 14 Phone: 202-564-4167 15 Fax: 202-564-0035 16 Em ail: 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 m i nim u m , a 21 narrative description of activities undertaken, com p liance with the schedules or m ilestones set 22 forth in the applicable Appendix, and a sum m a ry of costs incurred since the previous report. 23 b. If Respondent violates, or has reason to believe that it probably will violate, any 24 requirem e nt of this Consent Agreem ent , 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 becom e s aware of the violation, with an explanation of the violation’s likely 27 cause and of the rem e dial steps taken, or to be taken, to prevent or m i nim i ze such violation. If

141 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 the cause of a violation cannot be fully explained at the tim e the report is due, Respondent shall so state in the report. Respondent shall investigate the cause of the violation and shall then subm it an am endm ent to the report, including a full explanation of the cause of the violation, within thirty (30) days of the day Respondentbecom e s aware of the cause of the violation. During this thirty (30) day period Respondent shall not be deem ed to be in violation of this Consent Agreem ent. Failure by Respondent to com p ly with the notice requirem e nts 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 Agreem ent 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 Agreem ent (Force Majeure). 2. W h enever any violation of this Consent Agreem ent or any other event affecting Respondent’s perform a nce under this Consent Agreem ent m a y pose an im m e diate threat to the public health or welfare or the environm ent, Respondent shall notify EPA orally or by electronic or facsim ile transm ission as soon as possible, but no later than twenty-four (24) hours after Respondent first knew of, or should have known of, th e violation or event. This procedure is in addition to the requirem e nts set forth in the preceding Paragraph. 3. All reports and notices required under this Consent Agreem ent or its Appendices shall be subm itted to the person designated in Paragraph V.1.a. of this Consent Agreem ent.

151 4. Each report subm itted by Respondent under this Section, each final report as defined 2 in the applicable SEP, and each SEP Com p letion Report shall be signed by an official of the 3 subm itting party and include the f o llowing certif ication: 4 I certify under penalty of law that I have exam ined and am fam iliar 5 with the inf o rm ation subm itted in this docum ent and all attach6 m e nts and that this docum ent and its attachm e nts were prepared 7 either by m e personally or under my direction or supervision in a 8 m a nner designed to ensure that qualified and knowledgeable 9 personnel properly gather and present the inform ation contained 10 therein. I further certify, based on my personal knowledge or on 11 my inquiry of those individuals im m e diately responsible for 12 obtaining the inform ation, that the inform ation is true, accurate and 13 com p lete. I am aware that there are signif i cant penalties f o r 14 subm itting false inform ation, including the possibility of fines and 15 im prisonm ent for knowingly and willfully subm itting a m a terially 16 false statem ent.

17 This certification requirem e nt does not apply to em ergency or sim ilar notifications where 18 com p liance would be im practical. 19 5. Respondent agrees that EPA m a y at reasonable tim es and in a reasonable m a nner 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 perform a nce at any such location in order to confirm that each of the SEPs is 23 being undertaken in conform ity with the representations m a de 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 m a intain for a period of five (5) years after term ination of this 27 Consent Agreem ent legible copies of docum entation of the underlying research and data for any 28 and all docum ents or reports subm itted to EPA pursuant to this Consent Agreem ent or its 161 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Appendices and shall provide the docum entation of any such underlying research and data to EPA not m o re than thirty (30) days after a request for such inform ation, unless otherwise stated in an Appendix. 7. The reporting requirem e nts of this Consent Agreem ent do not relieve Respondent of any reporting obligations required by any federal, st ate, or local law, regulation, perm it, or other requirem e nt. 8. Any inform ation provided pursuant to this Consent Agreem ent m a y be used by the United States in any proceeding to enforce the provisions of this Consent Agreem ent and as otherwise perm itted by law. 9. All SEP Com p letion 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 im m e diately available for public review. Confidential Business Inform ation (CBI), if any, shall be redacted by Respondent and a statem ent inserted for each redacted item in the public version that Respondent declares that inform ation CBI. A CBI version of the report will be sent sim u ltaneously with the public version. VI. EXPENDITURES LESS THAN AGREED SEP MINIMUMS 1. If all activities under a SEP are satisfactorily com p leted, but Respondent expends less than the total am ount agreed upon for the SEP, the parties shall either: a) negotiate additional SEPs or b) negotiate to redirect the rem a ining m oney to a SEP already agreed to as part of this Consent Agreem ent to adjust for the balance of the unexpended funds.

171 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 2. If the parties cannot agree to additional SEPs and cannot agree to redirect the m oney to a SEP already agreed to under this Consent Agreem ent, then Respondent shall be considered to have not satisfactorily com p leted the SEP even though all work is satisfactorily perform e d. VII. STIPULATED PENALTIES 1. If a SEP is not satisfactorily com p leted only because Respondent expends less than the total am ount agreed upon for the SEP and the parties did not agree under Paragraph VI.2. to direct the m oney to an additional SEP or redirect the m oney to an existing SEP already agreed to under this Consent Agreem ent, Respondent shall pay a stipulated penalty equal to the difference between the am ount of eligible SEP costs incurred by the Respondent and the applicable am ount set forth in Paragraph IV.3. 2. If Respondent represents it has satisfactorily com p leted a SEP, but EPA notifies Respondent under Paragraph IV.8. that the SEP has not been satisfactorily com p leted for reasons other than, or in addition to, those set forth inParagraph VII.1, Respondent shall pay a stipulated penalty equal to the am ount 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 com p letion and EPA notifies Respondent under Paragraph IV.8. that the SEP has not been satisfactorily com p leted because the cessation is contrary to the provisions of the SEP or of this Consent Agreem ent, Respondent shall pay a stipulated penalty equal to the am ount 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.

181 4. If Respondent fails to com p ly with the term s of this Consent Agreem ent or its 2 Appendices and the failure is not excused under the provisions of this Consent Agreem ent or its 3 Appendices, Respondent shall pay stipulated penalties as follows: 4 Violation S tipulated Penalty 5 6 7 8 9 10 11 12 13 a. Failure to pay the civil penalty specified in Paragraph III.3. above. $5,000 per day b. Failure to tim ely subm it, m odify, or im plem ent, as approved, reports (including SEP Com p letion Reports), studies, analyses, protocols, or other subm ittals required in this Consent Agreem ent 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 Agreem ent or its Appendices. $1,000 per day per violation

14 5. All stipulated penalties shall begin to accrue on the day after the perform a nce is due or 15 on the day a violation occurs, whichever is applicable, and shall continue until perf orm a nce is 16 satisfactorily com p leted or until the violation ceases, whichever is applicable. Nothing in this 17 Consent Agreem ent shall prevent the sim u ltaneous accrual of separate stipulated penalties for 18 separate violations of this Consent Agreem ent. 19 6. EPA m a y, in its unreviewable discretion, waive paym ent of any portion of stipulated 20 penalties that m a y accrue under this Consent Agreem ent. 21 7. All stipulated penalties are due and owing, upon written dem a nd by EPA, no later 22 than sixty (60) days after Respondent receives such dem a nd. 23 8. All stipulated penalties shall be paid in a m a nner set forth in Paragraph III.3. 24 9. In any action concerning EPA’s assessm ent of a stipulated penalty under this Consent 25 Agreem ent, EPA shall be entitled to judgm ent for the claim e d penalty am ount unless Respondent

191 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 dem onstrates, and the court finds, that EPA acted arbitrarily or capriciously in its determ ining that stipulated penalties should be assessed against Respondent. VIII. EPA ACCEPTANCE OF SEP COMPLETION REPORT 1. W ithin sixty (60) days after receipt of each SEP Com p letion Report described in Section V.1., above, EPA shall notify the Respondent, in writing, that: a) the SEP Com p letion Report does not com p ly with Paragraph IV.6. in which case Respondent shall have an opportunity in accordance with Paragraph VIII.2., unless the parties agree to additional tim e, for Respondent to correct the deficiencies; or b) the SEP Com p letion Report com p lies with Paragraph IV.6. and the project has been com p leted satisfactorily; or c) the SEP Com p letion Report com p lies with Paragraph IV.6. but the SEP has not been satisfactorily com p leted and stipulated penalties m a y be assessed. Before EPA assesses stipulated penalties, Respondent m a y invoke the procedure in Paragraph IV.8. 2. If EPA notifies Respondent that a SEP Com p letion Report does not com p ly with Paragraph IV.6 but EPA has not yet m a de a fina l determ ination about whether that particular SEP has been satisfactorily com p leted, Respondent shall have ten (10) business days following receipt of such notice to object to the Agency’s determ ination. Respondent’s objection m u st be in writing and subm itted to the person in Paragraph V.1. EPA and Respondent shall have an additional thirty (30) days from the recei pt by EPA of Respondent’s objection to reach agreem ent on changes necessary to the SEP Com p letion Report. If agreem ent cannot be reached on any such issue within this thirty (30) day period, EPA shall provide a written statem ent of its decision to Respondent, which decision sh all be final and binding upon Respondent.

201 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 3. In the event the SEP Com p letion Report does not com p ly with Paragraph IV.6. and the parties have com p leted the procedure in Paragraphs VIII.1. and VIII.2., EPA m a y assess stipulated penalties against Respondent in accordance with Paragraph VII.4.b. IX. OTHER MATTERS 1. Respondent m a y request, and EPA m a y grant, an extension of tim e for any action required of Respondent under this Consent Agreem ent. 2. Paym ent 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 coll ection, including processing and handling costs and attorneys fees. In addition, a non-paym ent penalty charge of six (6) percent per year

com pounded annually will be assessed on any portion of the debt which rem a ins delinquent

m o re than ninety (90) days after paym ent is due. Any such non-paym ent penalty charge on the debt will accrue from the date the penalty paym ent becom e s due and is not paid. 4 C.F.R. §§ 102.13(d) and (e). 3. Nothing in this agreem ent shall be construed as prohibiting, altering or in any way lim iting the ability of EPA to seek any other m onetary or non-m onetary rem e dies or sanctions to which EPA is legally entitled, including but not lim ited to injunctive relief or an action to collect stipulated penalties, for Respondent' s violation of: 1) any provision of law not resolved by the settlem e nt of claim s for civil penalties pursuant to TSCA and RCRA as alleged in the

211 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Consolidated Action and the violations alleged in Section II, above, or 2) any applicable requirem e nt under this Consent Agreem ent or its Appendices except that EPA will not seek to

com p el perform a nce of a requirem e nt in Appendices A or B. 4. This Consent Agreem ent and Final Order shall not relieve Respondent of its obligation to com p ly with all applicable provisions of federal, state or local law, nor shall it be construed to be a ruling on, or determ ination of, any issue related to any federal, state or local perm it. 5. Force Majeure:

a. If any event occurs which causes or m a y cause delays in com p lying with this Consent Agreem ent or its Appendices, Respondent shall notify Com p lainant in writing not m o re 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 m e asures taken and to be taken by Respondent to prevent or m i nim i ze the delay, and the tim etable by which those

m easures will be im plem ented. The Respondent shall adopt all reasonable m easures to avoid or

m i nim i ze any such delay. Failure by Respondent to com p ly with the notice requirem e nts 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 Agreem ent or its Appendices based on such incident. b. If the parties agree that the delay or anticipated delay in com p lying with this Consent Agreem ent or its Appendices has been or will be caused by circum stances entirely beyond the control of Respondent, the tim e for perform a nce hereunder m a y be extended for a

221 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 period no longer than the delay resulting from such circum stances. In such event, the parties shall agree to such extension of tim e, during which period Respondent shall not be deem ed to be in violation of this Consent Agreem ent or its Appendices.

c. In the event that EPA does not agree that a delay in com p lying with this Consent Agreem ent or its Appendices has been or will be caused by circum stances beyond the control of the Respondent, EPA will notify Respondent in writing of its decision and any delays in the com p letion of the affected SEP shall not be excused. d. The burden of proving that any delay is caused by circum stances entirely beyond the control of the Respondent shall rest with the Respondent. Increased costs or expenses associated with the im plem entation of actions called for by this Consent Agreem ent shall not, in any event, be a basis for changes in this Consent Agreem ent or extensions of tim e under section (b) of this Paragraph. Delay in achievem e nt of one interim step shall not necessarily justify or excuse delay in achievem e nt of subsequent steps; it is Respondent’s burden to establish that a delay in achievem e nt of one interim step justifies or excuses delay in achievem e nt of subsequent steps. 6. For purposes of Federal taxes, Respondent indicates that it does not intend to deduct funds expended in the perform a nce of the SEPs from the com p any’s incom e except to the extent and in the event that such costs exceed six m illion two hundred fifty thousand dollars, ($6,250,000). 7. This Consent Agreem ent and Final Order constitutes a f i nal settlem e nt by EPA of the claim s 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

231 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 pursuant to TSCA or RCRA for any allegations in the Consolidated Action or in Section II, above. Nothing in this Consent Agreem ent and Final Order is intended to, nor shall be construed to operate in any way, to resolve any crim inal liability of the Respondent. Except for the claim s settled in this Consent Agreem ent and Final Order, com p liance with this Consent Agreem ent and Final Order shall not be a defense to any actions subsequently comm e nced pursuant to Federal laws and regulations adm i nistered by EPA, and it is the responsibility of Respondent to com p ly with such laws and regulations. 8. Each undersigned representative of the parties to this Consent Agreem ent certifies that he or she is fully authorized by the party represented to enter into the term s and conditions of this Consent Agreem ent and to execute and legally bind that party to it. 9. Respondent’s obligations under this Consent Agreem ent and its Appendices shall term inate upon Respondent: a) paying the civil penalty specified in Paragraph III.3., above, and either b) satisfactorily com p leting all SEPs and paying any stipulated penalty due under Paragraph VII.4. or, c) paying stipulated penalties under Paragraphs VII.1-3. W ithin thirty (30) days of term ination of Respondent’s obligations of this Consent Agreem ent and its Appendices in accordance with this Paragraph, the parties shall file a notice of term ination thereof with the Headquarters Hearing Clerk. 10. The effect of settlem e nt described in Section IX.7., of this Consent Agreem ent and Final Order is conditional upon the accuracy of the Respondent’s representations to EPA that EPA relied upon in settling this m a tter.

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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 Nem ours ) Docket No. TSCA-HQ-2004-0016 and Com p any ) Docket No. RCRA-HQ-2004-0016 11 ) D ocket No. TSCA-HQ-2005-5001 12 W ilm ington, DE ) 13 ) 14 ) Respondent ) 16 ) 17 W a shington W o rks Facility ) 18 Route 892 South DuPont Road ) 19 W a shington, W ood County, W V ) ) 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 am ended by the Hazardous and Solid W a ste Am endm ents (“HSW A ”), 42 U.S.C. §§ 6901 et seq ., 26 it is hereby ORDERED THAT: 27 1. Respondent shall com p ly with all of the te rm s of the Consent Agreem ent, incorporated 28 herein by reference, including the term s of the C onsent Agreem ent relating to perform a nce of the 29 SEPs attached to and incorporated in the Consent Agreem ent; 2. Nothing in the Consent Agreem ent relieves Respondent from com p lying with the 31 requirem e nts set forth in TSCA and RCRA and the regulations thereunder; 32 3. Respondent is assessed a civil penalty in the sum of (Ten Million Tw o 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 Am erica", in the am ount of $ 10,250,000 to: 37 EPA-W a shington 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 15251-62771 or an electronic paym ent of $ 10,250,000 by wire transfer as instructed in this agreem ent. 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 rem it 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 becom e subject to the 6 stipulated penalty of five thousand dollars ($5,000) per diem im m e diately, plus interest as 7 allowed by law, and without further proceedings.

8 IT IS SO ORDERED. 9 10 Environm ental Appeals Board 11

12 13 Date__________ Environm ental Appeals Judge 14 U.S. Environm ental Protection Agency 15

21 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 docum ent, Appendix A, describes the Fluorotelom er-Based Product 8 Biodegradation Testing Supplem ental Environm ental Project (“Biodegradation SEP”) that 9 Respondent, E. I. du Pont de Nem ours and Com p a ny (“DuPont”) has agreed to perform pursuant 10 to Section III of the Consent Agreem ent and Final Order (“CAFO”) in TSCA-HQ-2004-0016, et 11 al. , entered into between DuPont and the United States Environm ental 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 com p liance with, and in addition to, the requirem e nts of the CAFO, DuPont, shall 15 (1) com p ly with the requirem e nts of this Appendix and Attachm e nts A-G, and (2) require any 16 entity that DuPont contracts with to fulfill DuP ont’s obligations under this SEP, to com p ly with 17 the requirem e nts of this Appendix and Attachm e nts A-G. 18 C. Purpose and Background

. The purpose of this Biodegradation SEP is to determ ine 19 the degradation potential of the nine com m e rcial fluorotelom er-based products identified in 20 Attachm e nt A to this Appendix (“the Fluorotel om er Products” or “Fluorotelom er Products”) as 21 well as the degradation potential of corresponding synthesized or purified polym ers equivalent to 22 the Fluorotelom er Products with respect to the chem ical com position that creates their 23 fluorotelom er functionality (“Corresponding Poly m e rs”). Eight of the nine Fluorotelom er

11 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Products to be tested under this Biodegradation SEP are fluorotelom er-based polym ers, while the ninth is a fluorotelom er-based phosphate ester. The Fluorotelom er Products are products that were sold by DuPont prior to the date DuPont signs the Consent Agreem ent, and that DuPont will provide as the chem ical substances to be tested pursuant to this Biodegradation SEP. An understanding of the degradation potential of th e Fluorotelom er Products will be developed by considering the results of both OECD Guideline 303A and sem i -continuous activated sludge (SCAS) studies. Accordingly, this Biodegradati on SEP is designed to: (1) provide inform ation regarding the behavior of the Fluorotelom er Products and their Corresponding Polym e rs in activated sludge biological wastewater treatm e ntsystem s using a sim u lated sewage treatm e nt plant test (OECD Guideline 303A), and (2) provide inform ation on the inherent biodegradation potential of the Fluorotelom er Products and their Corresponding Polym e rs using SCAS.

a. The OECD Guideline 303A study is a sewage treatm e nt plant (“STP”) sim u lation in activated sludge used to generate data concerning the fate of a test substance during biological treatm e nt, using laboratory-s cale aerobic STP. Conditions are controlled to sim u late the operating conditions of a wastewater treatm e nt plant. The study is designed to determ ine the elim ination of the test substance by aerobic m i croorganism s in a continuously operated test system sim u lating the activated sludge process. Naturally occurring carbon in the sewage feed and the test substance are the sources of carbon and energy for the m i croorganism s. The study investigates the distribution of the test substance and its degradation product(s) between the different phases in the test system : aqueous, biom ass (activated sludge), and gaseous. The laboratory will run the test f o r twelve (12) weeks and will m e asure analytes that are indicative of degradation by determ ining the am ount and rate of form ation of observed

21 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 degradation product(s) in the aqueous, sludge, and gas phases. Perform i ng OECD Guideline 303A on the Fluorotelom er Products and then com p aring the results to the sam e study perform e d on their Corresponding Polym e rs will enable a close look at the potential perform a nce of each of the Fluorotelom er Products and their Corresponding Polym e rs in a sewage treatm ent plant sim u lation. b. The m odified SCAS test is an inherent biodegradability study in which the test substance is exposed to activated sludge m i croorganism s in an aerated, aqueous m e dium with periodic settling of the solids and renewal of the aqueous phase with f r esh m e dia and test substance. The laboratory will run the test f o r twelve (12) weeks and will m easure analytes that are indicative of degradation by determ ining the am ount and rate of form ation of observed degradation product(s) in the aqueous, sludge, and gas phases. Perform i ng SCAS on the Fluorotelom er Products and then com p aring the results to the sam e study perform e d on their Corresponding Polym e rs will enable a close look at the potential aerobic biodegradation of each of the Fluorotelom er Products. The test also gi ves an indication of the potential for rem oval of the test substances via sorption to the activated sludge inoculum

. D. Use and Functionality of Fluorotelomer Products

. Fluorotelom er products are used widely in a range of com m e rcial applications, including som e that are directly released into the environm ent, such as fire fighting foam s, as well as soil, stain, and grease resistant coatings on carpets, textiles, paper, and leather. Fluor otelom er products are aqueous dispersions. They originate from fluorotelom er iodides [F(C F2CF2)n-I; where n= 3,4,5 com m only] which are

com m e rcially m a de by reacting pentafluoroethyl i odide with tetrafluoroethylene to create evennum ber-carbon polyfluoroalky iodides. Although the telom e rization process can be used to

31 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 produce odd-num ber-carbon raw m a terials, those are not intentionally m a de or sold by DuPont. Fluorotelom er iodides are functionalized to cr eate a series of fluorotelom er raw m a terials [including other fluorotelom er iodides [F-(C F2-CF2)n-CH2-CH2-I, n = 3,4,5 com m only] and fluorotelom er alcohols [F-(CF2-CF2)n-CH2-CH2- OH, n = 2,3,4,5 etc.] that are then appended to an organic or inorganic m o iety that contains the fluorotelom er as a functional group. As an

exam ple, fluorotelom er acrylate m onom ers [F-(CF2-CF2)n-CH2-CH2-O-C(O)-CH=CH2, n = 3,4,5 com m only] are copolym erized with one or m o re of a group of hydrocarbon m onom ers to create an acrylic polym er with fluorotelom er functionality. The m o st com m on fluorotelom er

raw m a terial used in DuPont’s fluorotelom er pr oducts is the fam ily of fluorotelom er alcohols. These alcohols are generally further transform e d into polym eric and non-polym eric fluorotelom er-based products. This Biodegrada tion SEP involves the testing of polym eric and non-polym eric fluorotelom er products based on th ese com m on fluorotelom er interm ediates; any reference in this Biodegradation SEP to DuPont ’s com m e rcial Fluorotelom er Products and their Corresponding Polym e rs is a reference to both the polym eric and non-polym eric products. DuPont generally m a nufactures product concentrates as aqueous dispersions of fluorotelom er products that are sold to industria l custom ers who dilute, form ulate, and blend the fluorotelom er products. These custom ers then e ither apply these new form ulations to finished articles or sell them to other custom ers who apply them to finished articles. In this way, the DuPont com m e rcial Fluorotelom er Products being te sted 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 carri ed out on DuPont’s Fluorotelom er Products for the purpose of attem p ting to assess the biodegradation potential of cured fluorotelom er-based

41 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 polym er products would need to be carefully done given the differences between the cured and uncured fluorotelom er-based products. Substances m a de with fluorotelom er functionality should not be referred to as either “perfluorinated” or “fluoropolym ers” as these term s describe other

ma t e r i a l s . E. As part of this Biodegradation SEP, DuPont will: 1. Provide suf f i cient quantities, as described in Sections II.D-E, below, of DuPont’s nine Fluorotelom er Products, listed in Attachm e nt A. 2. Prepare the following chem ical substances (referred to collectively as “Corresponding Polym e rs”).

a. A purified polym er for each of the Fluorotelom er Products listed in Attachm e nt A that has been isolated from th e Fluorotelom er Product and redispersed (“Purified Fluorotelom er Product”). On or before Fe bruary 1, 2006, DuPont and EPA will agree on the procedure(s) that DuPont will use to purify th e Fluorotelom er Products to produce the Purified Fluorotelom er Products, taking into consideration the need to optim ize various factors, including the appropriate duration of extraction and redispersion processes, the desired purity of the Purified Fluorotelom er Products, the schedule for delivery of the Purified Fluorotelom er Products to the laboratories for characterization, testing and studies, and the overall schedule for

com p leting this Biodegradation SEP. W ithin seven (7) business days of producing each Purified Fluorotelom er Product, DuPont shall provide EP A with the procedure(s) used to produce such Purified Fluorotelom er Product and the purity le vel achieved for such Purified Fluorotelom er Product.

51 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 b. A synthesized fluorotelom er pr oduct containing a purified polym er,

com p arable to the Fluorotelom er Product for which it corresponds, that is prepared in the laboratory using production plant raw m a terial s (“Synthesized Fluorotelom er Product”).

c. A synthesized fluorotelom er product containing a purified polym er,

com p arable to the Purified Fluorotelom er Product for which it corresponds, that is prepared in the laboratory using high purity raw m a terials (“ Lab-scale Synthesized Fluorotelom er Product”). 3. Timing of Test Substance Transfer.

a. W ithin thirty (30) days of entering into a contract with (1) the laboratory perform i ng biodegradation and (2) the laboratory perform i ng characterization, DuPont shall transf er the suf f i cient quantities, as described in Sections II.D-E, below, of the nine Fluorotelom er Products to such laboratories. b. W ithin thirty (30) days of entering into a contract with (1) the laboratory perform i ng biodegradation and (2) the laboratory perform i ng characterization, DuPont shall transf er the suf f i cient quantities, as described in Sections II.D-E of the Corresponding Polym e rs, identified on Attachm e nt A for pilot testing, to such laboratories.

c. DuPont shall transf er suf f i cient quantities, as described in Sections II.D-E, of the Corresponding Polym e rs that EPA selects for biodegradation studies to such laboratories to tim ely com m e nce 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 characteri ze the Fluorotelom er Products, their Corresponding Polym e rs identified in Attachm e nt A for pilot testing, and any of their Corresponding Polym e rs

61 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 selected by EPA for biodegradation studies accordi ng to Attachm e nt B param e ters to help inform the results of the biodegradation studies. The characterization of these Fluorotelom er Products and Corresponding Polym e rs, discussed in greater detail in Attachm e nt B, will determ ine, using the m o st accurate instrum e ntation and procedures available as of the tim e of testing, and the best achievable precision, the am ount of residual m onom ers and oligom ers, other residuals, and the

m o lecular weight distribution of polym eric m a terial in the Fluorotelom er Products and Corresponding Polym e rs. 5. Third Party Laboratory Contract: Biodegradation

. Contract with a Third Party Laboratory (“laboratory”) to:

a. Pilot test the Fluorotelom er Products and Corresponding Polym e rs, as identified in Attachm e nt A, following study guidelines for OECD Guideline 303A (aerobic sewage treatm e nt for activated sludge units) and m odified sem i -continuous activated sludge (SCAS). b. Perform OECD Guideline 303A and SCAS studies on the Fluorotelom er Products and any Corresponding Polym e rs selected by EPA to be used in the biodegradation studies.

c. The laboratory will conduct these biodegradation studies on the Fluorotelom er Products and any of their Corresponding Polym e rs in order to investigate the degradation potential of these Fluorotelom er Products to produce perfluorooctanoic acid (PFOA) or other analytes identified in Attachm e nt C, and to determ ine the potential, if any, for their Corresponding Polym e rs to degrade to form PFOA or other analytes identified in Attachm e nt C.

71 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 6. Panel Administrator Contract

. Contract with an independent third party (“Panel Adm i nistrator”) to im plem ent and adm i nister 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 m ilestones. E. Applicability of Results

. Because this Biodegradation SEP is designed to exam ine (1) the inherent biodegradation potential of the Fluorotelom er Products and their Corresponding Polym e rs and (2) the biodegradation potential and fate of the Fluorotelom er Products and their Corresponding Polym e rs under aerobic sewage treatm e nt plant sim u lation conditions, it does not address the biodegradation potential of the Fluorotelom er Products or their Corresponding Polym e rs in soil, sedim e nts, landf ills, or aquatic or m a rine system s, nor does it address degradation under anaerobic conditions. Additionally, using the results of this Biodegradation SEP to attem p t to assess the biodegradation potential of cured polym ers would need to be carefully done given the differences between cured and uncured fluorotelom er-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 Harm onized System for the Classification of Chem icals which are Hazardous for the Aquatic Environm ent (April 2001), a positive result in an inherent biodegradation test indicates that the test substance will not persist indef i nitely in the environm ent; however, rapid and com p lete biodegradation cannot be assum e d. A negative resu lt in an inherent biodegradation test does not definitively dem onstrate that a chem ical will not biodegrade under any conditions, but rather that the chem ical will not biodegrade under the conditions of the test. Aerobic sewage treatm e nt sim u lation tests are designed to yield inform ation on the behavior of chem icals in aerobic

81 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 sewage treatm e nt plants. These tests perm it the m easurem ent of the rates of loss of the test chem ical, form ation and identification of degradation products, partitioning of these chem icals to sludge solids, and volatilization under conditions controlled to m i m i c those found in full-scale aerobic wastewater treatm e nt system s. The results from these studies are indicative of how the test substance will behave in f u ll-scale system s. II. GENERAL OBLIGATIONS AND REQUIREMENTS A. Total Cost

. DuPont m u st spend no less than five m illion dollars ($5,000,000) in eligible SEP costs in perform i ng activities under this Biodegradation SEP, but is not required to spend m o re than five m illion dollars ($5,000,000) in eligible SEP costs. B. SEP Completion

. DuPont shall com p ly with the deadlines set forth in this Appendix and will use its best ef f o rts to satisf actorily com p lete this Biodegradation SEP, within the

m eaning of Section IV.4 of the CAFO, no later than three (3) years from the date DuPont receives the signed Final Order of the Environm ental Appeals Board approving the Consent Agreem ent (“SEP Com p letion Date”). No later than sixty (60) days prior to the SEP Com p letion Date, if DuPont believes that it will be unable to satisf actorily com p lete the SEP within such three-year period, DuPont shall petition EPA to extend the SEP Com p letion Date based upon DuPont’s assertion of good cause to extend such date. The Office of Civil Enforcem ent, in consultation with the Of f i ce of Pollution Preven tion and Toxics, will review DuPont' s petition and m eet with DuPont to discuss its petition. The Office of Civil Enforcem ent, in consultation with the Office of Pollution Prevention and Toxics, shall determ ine whether DuPont has dem onstrated that there is good cause to extend the SEP Com p letion Date and, if determ ining that DuPont has dem onstrated good cause, determ ine how long to extend the SEP Com p letion

91 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Date. C. Good Laboratory Practices and Study Monitor

. For purposes of this Biodegradation SEP, with regard to characterization and bi odegradation testing and studies, DuPont and its contractors shall be subject to, and m u st com p ly 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 Fluorotelom er Products, identified in Attachm e nt A, and any Corresponding Polym e rs, 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 Polym e rs, identified in Attachm e nt A for pilot testing, m u st include the quantities necessary to perform characterization, the pilot tests, and biodegradation studies, even if such Corresponding Polym e rs are not selected by EPA to be used in the biodegradation studies. Each Fluorotelom er Product and Purified Fluorotelom er Product that DuPont provides to the laboratory perform i ng char acterization m u st be from the sam e production batch as provided to the laboratory perform i ng the biodegradation studies. Each Synthesized Fluorotelom er Product and Lab-scale Synthesized Fluorotelom er Product that DuPont provides to the laboratory perform i ng characterization m u st be from the sam e laboratory batch as provided to the laboratory perform i ng biodegradation testing.

101 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 E. Supply of Test Substances to EPA

. EPA shall receive sufficient quantities of the Fluorotelom er Products identified in Attachm e nt A, and Corresponding Polym e rs, to replicate the characterization and biodegradation studies ( i.e. , OECD Guideline 303A and SCAS tests (including pilots)) perform e d under this Biodegradation SEP. DuPont shall fulfill this obligation by providing these sufficient quantities of the Fluorotelom er Products and Corresponding Polym e rs to the laboratory perform i ng characterization. In dividing the sam p les 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 am ount for the laboratory to also perf orm characterization and then shall provide the larger rem a inder of each divided sam p le to EPA following the chain of custody procedures in Attachm e nt D. DuPont and the laboratory perform i ng characterization shall develop appropriate holding procedures for the test substances to assure the chem ical 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 sam p les to EPA. F. Chain of Custody

. Any instance in which, pursuant to this Biodegradation SEP, DuPont or a laboratory transfers either Fl uorotelom er Products, Corresponding Polym e rs, or other chem icals to a laboratory or to EPA, DuP ont and/or such laboratory(ies) are required to follow the chain of custody procedures in Attachm e nt 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 agreem ents, lists, m a terial m odifications, and any other subm ission other than a final report, progress report, prelim inary report, or quarterly report,

111 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 relating to perform a nce of this Biodegradation SEP. 1. In providing com m e nts to DuPont regarding such docum ents or subm issions, EPA will include justif ication(s) and/or rationale(s) f o r the com m e nts. EPA will provide such

com m e nts to DuPont within a reasonable am ount of tim e, com m e nsurate with the type and nature of the docum ent or subm ission being reviewed. 2. All of EPA’s com m e nts, including requested changes, to a docum ent or subm ission enum erated above m u st be incorpor ated by DuPont, and/or its contractors, and resubm itted to EPA for approval. W ith regard to contracts, request for proposals/bids, and conf identiality agreem ents, if DuPont believes that EPA’s comm e nts do not relate to the perform a nce of the Biodegradation SEP, DuPont shall notify EPA within seven (7) business days of DuPont’s receipt of such com m e nts. In this notification to EPA, DuPont shall explain why it believes that EPA’s comm e nts do not relate to the perform a nce of this Biodegradation SEP and that such com m e nts are not required to be incorporated into the docum ent. EPA shall consider DuPont’s explanation before m a king a final decision regarding whether such comm e nts relate to the perf orm a nce of this Biodegradation SEP; provided, however, that EPA will not unreasonably require DuPont to m odify or rem ove from a ny such contract or agreem ent any provision that requires the contractor to indemn ify DuPont fo r stipulated penalties that DuPont pays under Section VII.4 of the CAFO as a result of the c ontractor’s failure to perform work in accordance with a schedule to which the contractor has agreed. 3. In lim ited circum stances, EPA m a y, in its discretion, after reviewing a proposed contract, proposed confidentiality agreem en t, or proposed protocol opt to accept such a docum ent without form ally approving it. If EP A exercises this option, EPA will notify DuPont

121 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 that the proposed contract or proposed confidentiality agreem ent has been accepted. H. Submission Procedures and Transfer of Test Substances to EPA

. All subm issions by DuPont, a laboratory, or the Panel Adm i nistrator to EPA shall be subm itted via f i rst class

m a il, return receipt requested, or by com m e rcial delivery service with docum ented delivery, to the person identified in Section V of the CAFO. All subm issions shall be provided in electronic form at on a com p act disc (CD). All subm issions shall be accom p anied by a cover letter in hardcopy, that describes the contents of the CD, and com p lies with any other requirem e nts of the CAFO. EPA will specif y, in advance of the transf er of test substances addressed in Section II.E, above, where to transfer such divided sam p les. I. Final Reports containing Confidential Business Information

. All final reports provided to EPA containing Confidential Business Inform ation (“CBI”) m u st also be provided to EPA in a sanitized version within thirty (30) da ys of subm ission 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 Com p letion Reports subm itted pursuant to Section IV of the CAFO. Any claim of CBI m u st be substantia ted pursuant to 40 C.F.R. Part 2, upon subm ission of the sanitized version. J. Manner in which Testing and Studies shall be Performed

. The characterization and biodegradation studies m u st be perform e d in the following m a nner and in com p liance with the following Attachm e nts, unless DuPont or its cont ractor requests, and EPA approves, a change, or if EPA, after consultation with DuPont, determ ines that a change is appropriate: 1. DuPont shall use one laboratory to characterize the Fluorotelom er Products, the Corresponding Polym e rs identified in Attachm e nt A for pilot testing, and any Corresponding

131 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Polym e rs that EPA selects for biodegradation studies, in accordance with Attachm e nt 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 Attachm e nt C.

a. This laboratory shall perform the OECD Guideline 303A and SCAS studies concurrently on the Fluorotelom er Products and any Corresponding Polym e rs that EPA selects for biodegradation studies, following both the sequence, and grouping (to m a xim i ze laboratory efficiency, capacity allowing) provided in Attachm e nt A. b. If, based on their subm issions in response to the Request for Proposals (“RFP”) and any further inform ation that DuP ont or EPA receives, none of the laboratories identif ied in Attachm e nt G appears to be reasonably capable of , or if no laboratory is willing to contractually com m it to, com p leting all of the biodegradation studies (including pilots) by no later than twenty-seven (27) m onths after receipt of the Fluorotelom er Products and any Corresponding Polym e rs (or such longer tim e as EPA approves), the parties agree to im plem ent the following approach, in the following order of preference: i. DuPont shall use one laboratory identified in Attachm e nt G to perform the biodegradation studies but not the an alytical com ponent of the studies, and DuPont shall use the laboratory that DuPont contract s with to perform characterization of the Fluorotelom er Products and any Corresponding Poly m e rs under this Biodegradation SEP, as a subcontractor for the analytical com ponent of the biodegradation studies; or ii. DuPont shall propose two laboratories identified in Attachm e nt G to perform the biodegradation studies and shall propose how to divide the biodegradation

141 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 work between the two laboratories, subject to EPA approval. 3. Pilot Testing

a. The laboratory perform i ng 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 Fluorotelom er Products that have been selected for pilot testing as identified in Attachm e nt 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 Polym e rs that have been selected for pilot testing as identified in Attachm e nt 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 Fluorotelom er Products and any Corresponding Polym e rs. b. EPA reserves the right, after reviewing the results of the first pilot of the Fluorotelom er Products or first pilots of its Corresponding Polym e rs, to specify the use of the Corresponding Polym e rs for the pilot tests in the rem a ining 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 Adm i nistrator shall develop and forward to EPA and DuPont a final Panel report providing: (1) each participating Panel m e m b er’s com m e nts and

recom m e ndations on appropriate final protocols fo r the laboratory to use for the biodegradation studies and (2) com m e nts and recom m e ndations regarding which of the Corresponding Polym e rs should be used in the biodegradation studies. EPA will review the Panel report and any

com m e nts that DuPont has subm itted to EPA pursuant to Section II.K, below. EPA will then

151 2 3 4 5 6 7 8 9 10 11 12 13 14 15 transm it its com m e nts and judgm ents to DuPont and require DuPont to direct the laboratory to develop a f i nal protocol, within a specif i ed tim ef ram e , to be subm itted to EPA f o r approval. The final protocol that the laboratory develops shall consider the Panel report and EPA’s com m e nts and judgm ents. The laboratory shall not com m e nce the biodegradation studies until it has received EPA’s approval of the final protocol and EPA’s determ ination regarding which of the Corresponding Polym e rs shall be used in the biodegradation studies. K. At any tim e during the perform a nce of this Biodegradation SEP, DuPont m a y provide

com m e nts to EPA regarding the following technical docum ents: protocols, test m e thods, analytical m e thods (and any m odifications of su ch technical docum ents), and the Panel report addressing the charge set forth in Section V.A.2.b. To be eligible for consideration by EPA, DuPont m u st subm it such com m e nts to EPA within seven (7) business days of DuPont’s receipt of the technical docum ent. EPA reserves the ri ght to directly seek input from the appropriate laboratory regarding DuPont’s comm e nts. 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.

161 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 L. Extensions of deadlines other than the SEP Com p letion Date 1. First Extensions

. For an extension of a deadline specified in this Appendix or in a work plan or other subm ission im plem enting this Biodegradation SEP, other than the SEP Com p letion Date, DuPont shall be entitled to a f i rst extension as a m a tter of right, provided that DuPont subm its 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 autom a tically receive an extension equal to the num ber of days initially provided in this Appendix. b. For deadlines greater than thirty (30) days, DuPont shall autom a tically 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 term s of num ber of days after a preceding event but are stated as specific dates, DuPont shall autom a tically 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 Com p letion Date involving work that DuPont has contracted with a third party to perform , if, after exercising its right to an autom a tic extension provided in Section II.L.1, above, DuPont requests a second extension of the sam e 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

171 2 3 4 5 6 7 8 9 10 11 12 13 14 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 num ber 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 Com p letion Date for which there is either: (a) a second request for an extension of a deadline that does not involve work that DuPont has contr acted 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 m a y grant an extension of tim e different from the am ount of tim e requested by DuPont.

181 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 4. Delays resulting from EPA Review. If DuPont is delayed in perform i ng 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 subm ission that DuPont provided to EPA sufficiently in advance of the deadline so as to allow EPA a reasonable am ount of tim e to review and approve the subm ission, com m e nsurate with the type and nature of the subm ission, DuPont will be entitled to an extension to perform the required action. The extension shall be equal to the

num ber of days of EPA’s review and approval of the subm ission and shall be calculated from the date that EPA received such subm ission through the date that EPA transm itted its approval of the subm ission to DuPont. If, during its review and prior to its approval, EPA requests that DuPont

m a ke changes to the subm ission, in calculating the extension, the parties shall not include the

am ount of tim e for DuPont to m a ke such changes and resubm it the docum ent to EPA for approval. Such tim e excluded from the extension shall start from the date that EPA transm its the requested changes to DuPont through the date that EPA receives the am ended subm ission, incorporating the requested changes. But, such tim e excluded from the extension shall not include tim e during which EPA is still reviewing a portion of the subm ission f o r which EPA has also requested changes. If an extension is granted under this provision, DuPont m a y 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.

191 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 III. SELECTION OF THIRD PARTY LABORATORIES A. Development of Confidentiality Agreement

. W ithin forty-five (45) days from the date DuPont signs the Consent Agreem ent, DuPont shall subm it to EPA the conf identiality agreem ent that DuPont intends to use with any laboratory. W ithin seven (7) business days of receipt of EPA’s approval (or acceptance) of the confidentiality agreem ent, DuPont m u st provide the laboratories listed in Attachm e nt G with a conf identiality agreem ent and request that such conf identiality agreem ent 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 subm it to EPA one or m o re draft Requests for Proposals (RFPs) to be sent to all of the laboratories identified in Attachm e nt G to solicit proposals for (1) characterizing the Fluorotelom er Products and any Corresponding Polym e rs, and (2) conducting the OECD Guideline 303A and SCAS studies on the Fluorotelom er Products and any Co rresponding Polym e rs (including pilot testing). The proposed RFPs m u st at least include the following elem ents: 1. The laboratory’s obligation, if selected, to follow 40 C.F.R. Part 792, and prepare (or subcontract for preparation of) and com p ly with, a QAPP, provided in Attachm e nt E of this Appendix. 2. All existing inform ation that would be reasonably relevant to assisting the laboratory to develop a firm cost estim ate, with pricing, for the work that the laboratory is solicited to perform , which m u st include such inform ation as the identity, structure, and

com positional analysis of the Fluorotelom er Pr oducts. The laboratory’s proposal m a y be based upon not-to-exceed estim ates for the proposed work or any other m e thod that provides, to the

201 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 extent feasible, a firm cost estim ate for the work.

a. Laboratories receiving the RFP for characterization of the Fluorotelom er Products and Corresponding Polym e rs m u st provide cost estim ates for characterizing all of the Fluorotelom er Products and their Corresponding Polym e rs. b. Laboratories receiving the RFP for the biodegradation work m u st include cost estim ates for conducting 14-day pilot tests for OECD Guideline 303A and 14-day pilot tests for SCAS on the Fluorotelom er Products and the Corresponding Polym e rs, as identified in Attachm e nt A, and for perform i ng OECD Guideline 303A and SCAS studies on all Fluorotelom er Products and their Corresponding Polym e rs. 3. The laboratory’s cost proposal should include the identification of any analytical m e thods that the laboratory anticipates needing to develop in order to perform any of the required analytical work associated withthe 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 Attachm e nt C of this Appendix. 5. A requirem e nt that the recipient identify in its proposal a general schedule and budget for com p letion of the proposed work id entified 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 term s and conditions identified in Section III.F.2, below.

211 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 7. Notice that failure to subm it a proposal m eeting all of the criteria in the RFP to DuPont within thirty (30) days of the laborat ory’s receipt of the RFP m a y render the laboratory ineligible f o r selection. C. W ithin seven (7) days of receipt of the approved RFP, DuPont shall provide the EPAapproved RFPs to all laboratories listed in Attachm e nt G that have subm itted to DuPont a signed confidentiality agreem ent. If DuPont has not received a signed confidentiality agreem ent 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 confidentia lity agreem ent and, if such laboratory agrees within seven (7) business days of contact by EPA to sign and subm it the conf identiality agreem ent to DuPont, DuPont shall then provide the RFP to the laboratory. D. Laboratory Eligibility

. W ithin forty-five (45) days of EPA’s approval of the RFPs, or such longer tim e as EPA has approved in accordance with Section III.D.2, below, DuPont

m

u st receive a firm proposal back from a laborat ory 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 subm it one duplicate copy of its proposal to EPA concurrent with its subm ission to DuPont. 2. If a laboratory that received the RFP does not subm it 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 subm itted a proposal to DuP ont. If the laboratory indicates that it wants to subm it a proposal, the laboratory m u st 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 tim e

221 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 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 subm ission under III.D, DuPont m u st propose to EPA the laboratory that DuPont would like to use to perform the characterization of the Fluorotelom er Products and Corresponding Poly m e rs, and the laboratory that DuPont would like to use to perform the biodegradation studies of the Fluorotelom er Products and Corresponding Polym e rs. 1. DuPont m u st 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 subm itted a proposal to perform such work. 2. DuPont shall contract with only one laboratory to perform both the m odified SCAS and OECD Guideline 303A studies on the Fluorotelom er Products and Corresponding Polym e rs. DuPont shall contract with only one laboratory to characterize the Fluorotelom er Products and Corresponding Polym e rs. 3. If, after proposal subm ission, EPA rejects either the laboratory for characterization and/or the laboratory for biode gradation 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 subm it proposals to DuPont, or if none of the proposals subm itted is acceptable to EPA, the Directors of the Office of Civil Enforcem ent and the Office of Pollution Prevention and Toxics shall m eet with DuPont to discuss appropriate changes that

231 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 can be m a de to this Biodegradation SEP to fost er laboratory participation in the perform a nce of this Biodegradation SEP. EPA and DuPont shall first im plem ent the alternative approach set forth in Section II.J.2.b before EPA considers whether to expand the list of potential laboratories identified in Attachm e nt 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 subm it a proposal, this Biodegradation SEP shall be deem ed to have ceased prior to its com p letion, 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 pa rties m a y exercise Section VI of the CAFO even though this Biodegradation SEP is not deem ed satisfactorily com p leted. F. Laboratory Contract Requirements

. W ithin thirty (30) days of EPA’s approval of the laboratories under Section III.E, DuPont m u st pr ovide 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 m u st include the following term s and conditions in addition to the elem ents discussed in Section III.B, above:

a. The laboratory consents to inspection, for purposes of this Biodegradation SEP, at any reasonable tim e, as provided in 40 C.F.R. § 792.15. b. All laboratory personnel m u st directly answer any questions from EPA pertaining to work the laboratory is perform i ng under this Biodegradation SEP. Any request from EPA for written inform ation from a laborat ory pertaining to work it is perform i ng under this Biodegradation SEP will be transm itted through DuPont’s designated Study Monitor.

241 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 DuPont’s Study Monitor shall notify the laboratory of EPA’s request for such inform ation within three (3) business days of EPA’s request, and the laboratory shall provide such inform ation 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 inform ation so obtained, EPA believes that a m i nor m odification(s) to an appr oved or accepted test protocol or other analytical

m e thod m u st be m a de, EPA will inform DuPont of the m odification and require DuPont to instruct the laboratory to im plem ent the change im m e diately and continue running the test. DuPont m a y subm it com m e nts for EPA’s consideration regarding such m odification, in accordance with Section II.K, above. ii. If, based upon oral or written inform ation so obtained, EPA believes that a m odification to an approved or accep ted test protocol or other analytical m e thod

m

u st be m a de that requires the laboratory to stop the test and start again, EPA will inf o rm DuPont of the m odification and require DuPont to instruct the laboratory to provide EPA and DuPont with all data generated up to that date and im m e diately term inate the test and re-run the test im plem enting the m odification. DuPont m a y subm it com m e nts for EPA’s consideration regarding such m odification, in accordance with Section II.K, above.

c. EPA shall have the exclusive authority to approve all work plans, protocols, and test m e thods that the study spons or would otherwise approve under 40 C.F.R. Part 792 as well as any analytical m e thods not expre ssly enum erated in 40 C.F.R. Part 792, and the QAPPs. DuPont m a y subm it com m e nts for EPA’s consideration regarding such technical docum ents, in accordance with Section II.K, above.

251 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 d. Material Modifications

. Any proposed m a terial m odification that a laboratory or DuPont would like to m a ke that involves work conducted under this Biodegradation SEP m u st be approved by EPA prior to im plem entation. For purposes of this Biodegradation SEP, a m a terial m odification is an adjustm e nt to the work conducted under this Biodegradation SEP m a de in the norm a l course of im plem enting 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 m a kes any m odification 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 m odification is m a terial, EPA will orally notif y DuPont and the laboratory im m e diately, and require DuPont to instruct the laboratory to subm it such proposed m odification to EPA for approval within the tim efram e that EPA establishes in the oral notice. DuPont m a y subm it com m e nts for EPA’s consideration regarding such m odification, in accordance with Section II.K, above. f. Emergency Modifications

. In the event of an em ergency, the laboratory m a y m a ke a m odification that invol ves work previously approved by EPA under this Biodegradation SEP, to address an unf oreseen circum stance or occurrence that will have an adverse affect on the test if not im m e diately im plem ented. The laboratory shall provide notice to EPA and DuPont within twenty-four (24) hour s of such m odification. If, based upon this

m odification, EPA believes that the laboratory m u ststop the test and start again or that the laboratory should im plem ent an additional change, EPA will require DuPont to instruct the

261 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 laboratory to provide EPA and DuPont with all data generated up to that date and either im m e diately term inate the test and re-run the test or im m e diately im plem ent the additional change. DuPont m a y subm it com m e nts for EPA’s consideration regarding such m odification or additional change, in accordance with Section II.K, above. g. Progress Reports

. W ithin thirty (30) days of comm e ncing the technical work, and by the first day of each m onth thereafter until the laboratory subm its 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 perform e d, a copy of the raw data generated up to that date, and costs incurred. h. Information Exchange

. W h en the laboratory provides any inform ation in written form to EPA or DuPont concerning the laboratory’s work under this Biodegradation SEP, the laboratory shall provide such inform ation to the other party as soon as practicable. The laboratory is not responsible for dissem i nating inform ation that it receives in written form from DuPont; DuPont shall concurrently provide the inform ation to EPA. W h en the laboratory provides inform ation in oral form to EPA or DuPont concerning the laboratory’s work under this Biodegradation SEP, the laboratory shall comm unicate such inform ation to the other party as soon as practicable. The laboratory is not responsible for com m unicating inform ation it receives in oral form from DuPont or EPA; each party shall comm unicate such inform ation to the other party. However, when the laboratory receives anoral com m unication from DuPont or EPA, it shall notify both parties and provide a brief writte n description of such oral comm unication. To the extent practicable, the parties shall jointly com m unicate orally with the laboratory in light of the laboratory’s obligation to prepare a written notification to the parties when it receives an oral

271 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 com m unication, not jointly, from either party. i. The laboratory shall allow Peer Consultation Panel m e m b ers to visit the laboratory, as necessary, when the Peer Consulta tion Panel has a m eeting(s) and/or deliberations relevant to the work that the laboratory is perform i ng under this Biodegradation SEP. G. Contract Execution

. W ithin five (5) business days of receipt of EPA’s approval (or acceptance) of the proposed contract in accordance with Section II.G.2, DuPont m u st 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 m u st, inform EPA of the delay, explain the reason for the delay, provide a reasonable estim ate as to when the contract will be executed, and exercise its right to an autom a tic extension in Section II.L, above. After exercising its right to an autom a tic extension in Section II.L, but before a second request for an extension under Section II.L, if DuPont believe s that, notwithstanding its best efforts, the laboratory will not enter into the contract with DuPont, DuPont shall provide notice to EPA of the im passe. EPA reserves the right to contact such laboratory, upon receipt of such notice from DuPont, to inquire why the laboratory has not ente red into the contract with DuPont. If DuPont and the laboratory have not entered into a contr act within fourteen (14) days EPA’s inquiry, unless DuPont and EPA agree to a longer tim e period, then the parties shall follow the approach set forth in Section III.H, below. b. W ithin five (5) business days from the date that DuPont and the laboratory execute the contract, DuPont m u st notify EPA that it has entered into the contract with the

281 laboratory. 2 H. If no laboratory enters into a contract with DuPont, the Directors of the Office of 3 Civil Enforcem ent and the Office of Pollution Prevention and Toxics shall m eet with DuPont to 4 discuss appropriate changes that can be m a de to this Biodegradation SEP to foster laboratory 5 participation in the perform a nce of this Biodegrad ation 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 deem ed to have ceased prior to its 8 com p letion, 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 m a y exercise Section VI of the 10 CAFO even though this Biodegradation SEP is not deem ed satisfactorily com p leted. 11 I. Commencement of Work . W ithin thirty (30) days from the date that DuPont and each 12 laboratory execute the contract, the laboratory m u st com m e nce 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 Fluorotel om er Products and Corresponding Polym e rs 17 1. As provided in Section III.I, the laboratory shall comm e nce the work identified 18 in this Section IV.A, within thirty (30) days fr om the date that DuPont and the laboratory execute 19 the contract to perform work under this Biodegradation SEP. The laboratory shall com m e nce 20 such work by subm itting a work plan to EPA that describes the work the laboratory has been 21 contracted to perform , addressing all requirem e nts for such work under this Biodegradation SEP 22 (including Attachm e nt B), and a general schedule and budget for com p letion of the work. 23 W ithin forty-five (45) days from the date thatDuPont and the laboratory execute the contract to 291 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 perform work under this Biodegradation SEP, the laboratory shall subm it to EPA all relevant technical docum ents that require EPA’s approval. 2. W ithin fourteen (14) business days of EPA’s approval of the work plan and all relevant technical docum ents, the laboratory shall begin the im plem entation of the EPAapproved work plan. 3. W ithin fourteen (14) business days of characterizing each Fluorotelom er Product and any Corresponding Polym e rs, the laboratory shall provide EPA and the Panel Adm i nistrator, a Certificate of Analysis, as provi ded in Attachm e nt F, as well as the protocols and a copy of the raw data. The laboratory shall provide the QAPP to the Panel Adm i nistrator with the first Certificate of Analysis but need not provide the QAPP for the rem a ining eight Fluorotelom er Products and Corresponding Polym e rs. B. Biodegradation Studies: OECD Guideline 303A and SCAS 1. As provided in Section III.I, the laboratory shall comm e nce the work identified in this Section IV.B, within thirty (30) days from the date that DuPont and the laboratory execute the contract to perf orm such work. The laboratory shall comm e nce such work by subm itting a work plan to EPA that describes the work the laboratory has been contracted to perform , addressing all requirem e nts for such work under this Biodegradation SEP (including Attachm e nt C), and a general schedule and budget for com p letion of the work. W ithin ninety (90) days from the date that DuPont and the laboratory execute the contract to perform work under this Biodegradation SEP, the laboratory shall subm it to EPA all relevant technical docum ents that require EPA’s approval. 2. W ithin fourteen (14) business days of EPA’s approval of the work plan and all

301 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 relevant technical docum ents, the laboratory shall begin the im plem entation of the EPAapproved work plan.

a. The laboratory shall run the SCAS test for twelve (12) weeks. The inoculum source shall be activated sludge m i xe d liquor from a m unicipal wastewater treatm e nt plant operating in com p liance with its National Pollutant Elim ination Discharge System (“NPDES”) perm it. Settled dom estic sewage f r om a m unicipal wastewater treatm e nt plant operating in com p liance with its NPDES perm it shall be used as feed. Daily sam p les of the aqueous phase, sludge solids, and off gas shall be collected, analyzed, and quantified for the analytes listed in Attachm e nt C of this Biodegradation SEP. If at any tim e EPA determ ines, or if DuPont or the laboratory recom m e nds and EPA determ ines, that daily sam p ling is not necessary, EPA will notif y DuPont to instruct the laboratory of a change in the sam p ling schedule and establish a new tim efram e for sam p ling. Analyses shall be conducted using the m o st accurate instrum e ntation and procedures available as of the tim e of testing. All analytical m e thods 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 m i xed liquor from a m unicipal wastewater treatm e nt plant operating in com p liance with its NPDES perm it. Settled dom estic sewage from a m unicipal wastewater treatm e nt plant operating in com p liance with its NPDES perm it shall be used as feed. Daily sam p les of the aqueous phase, sludge solids, and off gas shall be collected, analyzed, and quantified for the analytes listed in Attachm e nt C of this Biodegradation SEP. If at any tim e EPA determ ines, or if DuPont or the laboratory recomm e nds and EPA determ ines, that daily sam p ling is not necessary, EPA will notif y DuPont to instruct the

311 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 laboratory of a change in the sam p ling schedule and establish a new tim efram e for sam p ling. Analyses shall be conducted using the m o st accurate instrum e ntation and procedures available as of the tim e of testing. All analytical m e thods sh all 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 Fluorotelom er Products that have been selected for pilot testing as identified in Attachm e nt 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 Polym e rs that have been selected for pilot testing as identified in Attachm e nt 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 Fluorotelom er Products and Corresponding Polym e rs. 4. Pilot Preliminary Reports

. No later than fourteen (14) days after the laboratory com p letes each pilot test, the laboratory shall provide EPA, DuPont, and the Panel Adm i nistrator with a prelim inary report regarding the pilot test results. In providing the prelim inary report, the laboratory shall sum m a rize the pilot test results and provide the QAPP, the protocols, and a copy of the raw data. 5. W ithin 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 Attachm e nt A.

321 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 a. EPA reserves the right to om it any analyte identified in Attachm e nt 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 Polym e rs that had not been characterized prior to the Panel’s report, and the am ount of

rem a ining eligible SEP dollars, EPA shall determ ine which of the Corresponding Polym e rs, if any, shall be used in the biodegradation studies. 6. Study Preliminary Reports

. W ithin seven (7) business days of the laboratory

com p leting the biodegradation studies on the first Fluorotelom er Product and any of its Corresponding Polym e rs (or first group of Fluorotelom er Products and any of their Corresponding Polym e rs), the laboratory shall subm it a prelim inary report sum m a rizing the study results to EPA, DuPont, and the Panel Adm i nistrator for distribution to the Peer Consultation Panel.

a. In providing the prelim inary 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 Adm i nistrator with the first Fluorotelom er Product and any of its Corresponding Polym e rs (or first group of Fluorotelom er Products and any of their Corresponding Polym e rs). b. As the laboratory com p letes biodegradation studies on each Fluorotelom er Product and Corresponding Polym e rs (or group of Fluorotelom er Products and Corresponding Polym e rs), the laboratory shall subm it prelim inary reports and associated inform ation described in Section V.B.6.a, above, to EPA, DuPont, and to the Panel Adm i nistrator for distribution to the Peer Consultation Panel.

331 C. Reporting Test and Study Results 2 1. Each laboratory shall follow 40 C.F.R. Part 792, subpart J in preparing the 3 f i nal report f o r the tests that it perf orm s . 4 2. Each laboratory m u st subm it a final report to EPA, DuPont, and the Panel 5 Adm i nistrator within thirty (30) days of com p leting all of the work identif ied 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 Adm i nistrator to im plem ent and 11 adm i nister the Peer Consultation process under this Biodegradation SEP. 12 1. The Panel Adm i nistrator 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 Adm i nistrator shall solicit potential Panel m e m b er 15 nom inations from the public, will allow self-nom ination, and m a y nom inate potential Panel 16 m e m b ers. The parties m a y subm it Panel m e m b er nom inations to the Panel Adm i nistrator. 17 b. After receiving Panel m e m b er nom inations, the Panel Adm i nistrator 18 shall develop a pool of potential Panel m e m b ers that will be subject to com m e nt by EPA, 19 DuPont, and the public. 20 c. After considering all com m e nts received regarding the Panel m e m b er 21 pool, the Panel Adm i nistrator shall select a potential Panel and subm it the potential Panel to EPA 22 and DuPont for comm e nt. The Panel Adm i nistrator has the exclusive authority to select the 23 Panel. If both parties, independently, recomm e nd to the Panel Adm i nistrator that a particular 341 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 potential Panel m e m b er would not be appropriate to serve on the Panel, the Panel Adm i nistrator shall rem ove such individual from the potential Panel and from the pool, select a new potential Panel from the pool of potential Panel m e m b ers, and then subm it a new potential Panel to EPA and DuPont f o r com m e nt. The Panel Adm i nistrator shall f o llow this approach until it has selected a final Panel. d. The Panel Adm i nistrator shall treat all com m e nts 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 Fluorotelom er Products and Corresponding Polym e rs for chem ical characteristics, com positional analysis, oligom eric content, m o lecular weight distribution, and residual content as discussed in Attachm e nt B of this Biodegradation SEP and determ ine: 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 comm e nts and recom m e ndations for developing a final design and protocol for the OE CD Guideline 303A and SCAS studies that will be approved by EPA prior to im plem entation by the laboratory.

c. Com p are the pilot results and characterization data of each Fluorotelom er Product to the pilot results and characterization data of its Corresponding Polym e r to advise EPA regarding the sim ilarities and differences of the Corresponding Polym e rs as

351 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 com p ared to the Fluorotelom er Products, and which, if any, of the Corresponding Polym e rs should be used in the biodegradation studies. i. If, based upon such com p arison, the Panel can identify one Corresponding Polym e r for each Fluorotelom er 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 Polym e r in the biodegradation studies. ii. If, based upon such com p arison, the Panel cannot identify one Corresponding Polym e r for each Fluorotelom er Product but can identify two Corresponding Polym e rs for a particular Fluorotelom er Product, the Panel shall so state, and provide a detailed explanation as to why it is appropriate to use the two Corresponding Polym e rs in the biodegradation studies. iii. If, based upon such com p arison, the Panel cannot identify two Corresponding Polym e rs for each Fluorotelom er Product and recomm e nds that all three Corresponding Polym e rs for a particular Fluorotelom er 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 Polym e rs in the biodegradation studies. iv. If, based upon such com p arison, the Panel cannot identify any Corresponding Polym e rs for a Fluorotelom er Product and recomm e nds that no Corresponding Polym e r 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 Polym e rs in the biodegradation studies.

361 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 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 Polym e rs that it recom m e nds should be used in the biodegradation studies but which were not pilot tested by the laboratory perform i ng the biodegradation work. d. Advise EPA regarding which analytes that were m easured for in the pilot tests should also be m easured for in the biodegradation studies.

e. Evaluate the results of the OECD Guideline 303A and SCAS studies perform e d on the fluorotelom er products and a ny corresponding purified fluorotelom er products, and advise EPA as to what the results m ean, both for the individual substances and for the group of test substances as a whole. f. Provide com m e nt on whether 14C labeling or other m e thods would enhance the characterization of the test substances, m easurem ent of the potential for biodegradation, and/or the evaluation of the biode gradation study results. If so, the Panel should describe how, and in what ways, the use of 14C-radiolabeled Lab-scale Synthesized Fluorotelom er Product would increase the usefulness of the results of the characterization and biodegradation studies. 3. EPA, after consultation with DuPont, m a y subm it additional, tim ely charges to the Panel that relate to, and are consistent with, the purposes of this Biodegradation SEP. 4. The Panel Adm i nistrator m a y request a clarification from EPA regarding the charges set forth in Section V.A.2, above. Such request m u st be m a de in writing. The Panel Adm i nistrator 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.

371 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 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 sum m a ry docum ent that reflects the individual opinions of the Panel m e m b ers. The Panel Adm i nistrator m a y designate fewer than all m e m b ers of the Panel to participate in providing advice on specific charges. Accordingly, at different tim es during the Peer Consultation process, the Panel m a y be com posed of different experts appropriate to the issue(s), but shall only be com posed of the experts that have been selected by the Panel Adm i nistrator to serve as m e m b ers of this Peer Consultation Panel. Wh ile consensus is not required, an accurate summ a ry of all opinions expressed by the individual m e m b ers m u st be subm itted to EPA. The Panel will not operate under a consensus-based process but rather should identify areas of agreem ent and disagreem ent, and provide supporting scientific rationale. Wh ile EPA will consider the advice and recomm e ndations it receives from the Panel, EPA is not bound by such advice or recom m e ndations. C. Qualifications and Requirem e nts for Panel Mem b ers 1. The Panel m u st be com posed of scientific experts who, collectively, have extensive and broad experience relevant to such areas as conducting and/or assessing biodegradation testing and environm ental fate of polym ers, and laboratory analysis and characterization of polym ers and fluoroche m i cals. Specific knowledge of fluorotelom er chem istry is desirable. 2. Panel m e m b ers m u st have sufficient technical expertise to m a ke m eaningful contributions to science-based evaluations. 3. Exam ples of the types of expertise that will be needed include, but are not lim ited to, conducting biodegradation testing, environm ental fate, polym er chem istry, analytical

381 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 chem istry under 40 C.F.R. Part 792, and/or fluorotelom er/ fluoropolym er chem istry. D. General Requirem e nts for the Peer Consultation Process 1. One Panel will be selected by the Panel Adm i nistrator and shall be com posed of at least four (4) but no m o re than eight (8) m e m b ers collectively m eeting the qualifications stated in Section V.C. 2. In selecting the Panel, the Panel Adm i nistrator shall use conf lict of interest guidelines approved by EPA. DuPont shall have an opportunity to review and provide

com m e nts to EPA regarding the conflict of interest guidelines. 3. The Panel Adm i nistrator shall subm it inf o rm ation to Adm i nistrative Record (AR) 226 to ensure that the public has an opportunity to nom inate panel m e m b ers, access to the Panel’s sanitized final reports, and access to all sanitized laboratory final reports. The Panel Adm i nistrator shall not disclose any inform ation that would be Toxic Substances Control Act Conf idential Business Inf o rm ation if subm itted to EPA. 4. Panel m eetings and deliberations will not be open to the public but will be open to DuPont and EPA em ployees and/or cont ractors with Toxic Substances Control Act Confidential Business Inform ation clearance. Such Panel m eetings and/or deliberations m a y also be open to other individuals or entities that EPA would like to attend, subject to conf identiality agreem ents, and prior approval f r om DuPont. 5. If practicable, Panel m eetings 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 m eetings and/or deliberations so that Panel m e m b ers can visit the laboratory, as needed.

391 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 6. EPA and DuPont m a y subm it written com m e nts to the Panel Adm i nistrator regarding technical docum ents developed by the laboratories under consideration by the Peer Consultation Panel. The Panel Adm i nistrator shall not provide such written comm e nts to Panel

m e m b ers in advance of any Panel m eetings or deliberations but only provide such comm e nts to the Panel m e m b ers at the tim e of the Panel m eetings or deliberations so as not to bias the Panel

m e m b ers’ prem eeting consideration of any particular issue under consideration. E. Selection and Responsibilities of the Panel Adm i nistrator 1. By February 1, 2006, the parties will agree to the Panel Adm i nistrator. 2. By March 15, 2006, DuPont m u st provide EPA with a final draft of the proposed contract that DuPont and the Panel Adm i nistrator have negotiated. The contract shall not be executed by DuPont and the Panel Adm i nistrator until EPA has reviewed and either approved or accepted the contract. The contract shall provide for appropriate confidentiality provisions. 3. W ithin seven (7) business days from receipt of EPA’s approval (or acceptance) of the proposed contract, DuPont m u st sign and fo rward the contract to the Panel Adm i nistrator for execution.

a. DuPont and the Panel Adm i nistrator shall seek to execute the contract within twenty-one (21) days of DuPont’s r eceipt of EPA’s approval (or acceptance) of the proposed contract. If DuPont and the Panel Adm i nistrator 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 m u st inform EPA of the delay, explain the reason f o r the delay, provide a reasonable estim ate as to when the contract will be executed, and

401 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 exercise its right to an autom a tic extension provided in Section II.L, above. However, if DuPont believes that, notwithstanding its best ef f o rts, the candidate Panel Adm i nistrator will not execute the contract with DuPont, DuPont shall provide notice to EPA of the im passe. EPA reserves the right to contact such candidate Panel Adm i nistra tor, upon receipt of such notice from DuPont, to inquire why it has not entered into the contract w ith DuPont. If DuPont and the candidate Panel Adm i nistrator have not entered into a contract within fourteen (14) days after EPA’s inquiry, unless EPA and DuPont agree to a longer tim e period, then the parties shall follow the approach set forth in Section V.E.4, below. b. W ithin five (5) business days from the date that DuPont and the Panel Adm i nistrator execute the contract, DuPont m u st notify EPA that it has entered into the contract with the Panel Adm i nistrator. 4. If no Panel Adm i nistrator enters into a contract with DuPont, the Directors of the Office of Civil Enforcem ent and the Office of Pollution Prevention and Toxics shall m e et with DuPont to discuss appropriate changes that can be m a de to this Biodegradation SEP to f o ster Panel Adm i nistrator participation in the pe rform a nce 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 Adm i nistrators enters into a contract with DuPont, this Biodegradation SEP shall be deem ed to have ceased prior to its com p letion, 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 m a y exerci se Section VI of the CAFO even though this Biodegradation SEP is not deem ed satisfactorily com p leted.

411 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 5. Peer Consultation Process Work Plan

. W ithin sixty (60) days of contract execution, the Panel Adm i nistrator m u st subm it to EPA a proposed work plan (including all applicable attachm e nts) that addresses the following:

a. The process, schedule, and budget for im plem enting and adm i nistering the Peer Consultation process under this Biodegradation SEP from the date the Panel Adm i nistrator executes the contract with DuPont through the date that the Panel Adm i nistrator subm its to EPA and AR226 the Panel’s final report from the last Panel m eeting. b. A description of the process for nom inating and selecting the Panel

m e m b ers, in accordance with Section V.A.1, above, and the rationale to be used in determ ining how m a ny experts to em panel to address the charges.

c. The schedule for the Panel to tim ely address the charges in Section V.A.2 to ensure the m o st efficient use of the Panel. i. The Panel Adm i nistrator shall com m unicate with the laboratory perform i ng the biodegradation testing to determ ine if it would be appropriate to have the Peer Consultation Panel review the results of the fi rst 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 chem ical substances identified in Attachm e nt A, i.e ., the three Fluorotelom er Products identified as the A group, and any Corresponding Polym e rs selected for testing, or any subsequent groupings identified in Attachm e nt A, as appropriate. The Panel Adm i nistrator m a y seek a recom m e ndation from the laboratory with regard to this issue and/or the Panel Adm i nistrator m a y m a ke its own determ ination after reviewing the data as to whether it is appropriate to convene the Peer

421 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Consultation Panel to review such results or to delay the review until all pilot tests and all biodegradation studies are com p leted. 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 m e m b ers. The Panel Adm i nistrator shall send the conf lict of interest guidelines to DuPont concurrent with its subm ission to EPA. DuPont shall have fourteen (14) business days to provide comm e nts to EPA regarding such conflict of interest guidelines.

e. The proposed contract for the Panel m e m b ers, including the proposed honorarium to be paid to each Panel m e m b er. f. The proposed confidentially agreem ents for the Panel m e m b ers. g. The process that the Panel Adm i nistrator will use to draf t, on behalf of the Panel, the Panel’s reports. The Panel Adm i nistrator m u st address the following: i. The process and schedule for the Panel Adm i nistrator to

com p ile com m e nts from the Panel; and ii. The process and schedule for the Panel Adm i nistrator to subm it a draft of the docum ent to the Panel m e m b ers for their review and com m e nt before such docum ent becom e s final. h. The num ber and tim ing of the Panel’s m eetings to address the charges identified in Section V.A.2. If the Panel Adm i ni strator would like to arrange a Panel m eeting or deliberation at a laboratory located outside of North Am erica, the Panel Adm i nistrator shall seek

431 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 prior approval from EPA before arranging such m eeting. i. A discussion of any other functi on(s) not expressly stated herein but that are necessary to im plem ent and adm i nister the Peer Consultation process under this Biodegradation SEP. 6. W ithin seven (7) days of receipt of EPA’s approval of the work plan, the Panel Adm i nistrator m u st com m e nce the Peer Consultation process, as described in the EPA-approved work plan. 7. The Panel Adm i nistrator is responsible for arranging Panel m e etings and/or deliberations, and acting as f acilitator during Panel m eetings and/or deliberations; coordinating exchange of inf o rm ation to Panel m e m b ers; subm itting all Panel reports to EPA and DuPont, with a sanitized version concurrently subm itted to AR 226; and for carrying out all other functions necessary to im plem ent and adm i nister the Peer Consultation process under this Biodegradation SEP. 8. Information Exchange

. W h en the Panel Adm i nistrator provides any inf o rm ation in oral or written f o rm to EPA or DuPont concerning the Peer Consultation process, the Panel Adm i nistrator shall provide such inform ation to the other party in the sam e form as soon as practicable. The Panel Adm i nistrator is not responsible for sharing inform ation it receives in oral or written form from EPA or Du Pont; the party providing such inform ation to the Panel Adm i nistrator shall concurrently provide the inform ation in the sam e form to the other party. However, when the Panel Adm i nistrator receives a substantive oral or written

com m unication from DuPont or EPA that im pacts the Panel Adm i nistrator’s im plem entation and/or adm i nistration of the Peer Consultati on process, it shall notify both parties of the

441 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 com m unication and provide a brief written description of the content of the com m unication. 9. Recom m e ndations, Advice, and Conclusions of the Panel

a. Final Panel Reports submitted to the Parties . W ithin forty-five (45) days of each Panel m eeting, the Panel Adm i nistrator shall subm it a final written report, on behalf of the Panel, to EPA and DuPont, that addresses the charge or charges under consideration at such m eeting. b. Final Panel Reports submitted to AR 226. W ithin thirty (30) days af

ter the Panel Adm i nistrator has subm itted a f i nal written report to EPA and DuPont, such f i nal written report and a sanitized version of such final written report shall be subm itted to AR 226. VI. Miscellaneous A. Eligible SEP Costs 1. The cost f o r providing suf f i cient quantities, as described in Sections II.D-E, above, of the Fluorotelom er Products for char acterization, biodegradation pilot tests, and biodegradation studies shall not be an eligible SEP Cost. 2. The cost of preparing suf f i cient quantities, as described in Sections II.D-E, f o r characterization of Corresponding Polym e rs identified for pilot testing in Attachm e nt A, and up to two additional Corresponding Polym e rs that the Panel recomm e nds pursuant to charge V.A.2.c, shall not be an eligible SEP Cost. 3. The cost of preparing suf f i cient quantities, as described in Sections II.D-E, f o r biodegradation pilot tests of the Corresponding Polym e rs, as identified on Attachm e nt A, shall not be an eligible SEP cost. 4. The cost of preparing suf f i cient quantities, as described in Sections II.D-E, f o r

451 2 3 4 5 6 7 8 9 10 11 12 13 biodegradation studies of up to two of the Corresponding Polym e rs 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 docum ent and have no legal m eaning 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 Attachm e nts, term s shall have the

sam e m eaning as provided in 15 U.S.C §§ 2601 et seq . and 40 C.F.R. Parts 2 and 792. Term s 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 Attachm e nts, shall be given the m eaning as defined in this Appendix or its Attachm e nts. E. Except as otherwise provided, all comm unications between the parties, including DuPont’s third party contractors, shall be in writing.

46APPENDIX A – BIODEGRADATION SUPPLEM ENTAL ENVIRONMENTAL PROJECT ATTACHMENT A The following table (which contains Toxic S ubstances Control Act Conf idential Business Inform ation) identifies the sequence and grouping of: (1) biodegradation pilot tests for the nine com m e rcial fluorotelom er-based products identified in Table 1 of this Attachm e nt (“Fluorotelom er Products”), (2) biodegradation pilot tests for corresponding synthesized or purified polym ers equivalent to the Fluorotelom er Products with respect to the chem ical com position that creates their fluorotelom er functionality (“Corresponding Polym e rs”), (3) biodegradation studies for the Fluorotelom er Pr oducts, and (4) biodegradation studies for any Corresponding Polym e rs. The first column, Pilot Test Group, identifies the order of the Fluorotelom er Products (and their Corresponding Polym e rs) for pilot testing and then specifies which of the Fluorotelom er Products (and their Corresponding Polym e rs) 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 Fluorotelom er Products separately from the Corresponding Polym e rs. The laboratory shall follow the alphabetical sequence ( i.e. , A, B, C, D) to determ ine the order for the Fluorotelom er Product pilot tests. The laboratory shall follow the num erical sequence within a group ( i.e. , A1, A2, A3) to determ ine which Fluorotelom er Products (and their Corresponding Polym e rs) in the group should be pilot tested first. The laboratory shall determ ine whether to pilot test the second or third chem ical in a group ( e.g. , in the A group, A2 and/or A3), by using the following approach. Using the A group as an exam ple, if the test substances in A1 (the Fluorotelom er Product and its Corresponding Polym e rs) can be evenly dispersed in the experim e ntal m a trix 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 rem a in dispersed in the experim e ntal m a trix or if the 8-2 FTOH and PFOA analytes are not quantifiable in the test system , the laboratory shall m a ke appropriate adjustm e nts during the pilot of A1 and shall pilot A2, applying the adjustm e nts it m a de during the pilot of A1 in its pilot of A2. If any of the test substances in A2 do not rem a in dispersed in the experim e ntal m a trix or if the 8-2 FTOH and PFOA analytes are not quantifiable in the test system , the laboratory shall m a ke appropriate adjustm e nts during the pilot of A2 and shall pilot A3, applying the adjustm e nts it m a de during the pilot of A2 in its pilot of A3. The laboratory shall f o llow this pilot testing approach for groups A, B, C, and D. The second column, Test Sequence Group, identifies the order of the Fluorotelom er Products and their Corresponding Polym e rs for biodegradation studies. This columnidentifies which Fluorotelom er Products and Corresponding Polym e rs can be grouped together for biodegradation studies, to m a xim i ze laboratory efficiency, capacityallowing. If the laboratory does not have the capacity to perf orm the biodegradation studies on m u ltiple chem icals at one tim e, then the laboratory shall follow the sequence order by Group num ber and Substance num ber to establish the testing sequence for each Fluorotelom er Product and any Corresponding Polym e rs. The TPL shall run the f i rst pilot ( i.e. , the pilot for test substance A1) and the 8-2 Alcohol control pilot concurrently.Table 1(Non-CBI)Pilot Test GroupTest Sequence OrderNon-CBI Chemical NameCAS NumberControl1Telomer B Alcohol1-Decanol,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10-heptadecafluoro678-39-7A1Group 1 Substance 2Polysubstituted urethaneA2Group 1 Substance 3Polysubstituted urethaneA3Group 1 Substance 1Fluorinated substituted urethaneBGroup 2 Substance 1Polysubstituted phosphate saltC1Group 3 Substance 3Polysubstituted acrylic copolymerC2Group 3 Substance 2Perfluoroalkyl acrylate copolymer latexC3Group 3 Substance 1Perfluoroalkyl acrylate copolymer latexD1Group 4 Substance 1Polysubstituted acrylic copolymerD2Group 4 Substance 2Polysubstituted methacrylic copolymerAPPENDIX A – BIODEGRADATION SUPPLEM ENTAL ENVIRONMENTAL PROJECT ATTACHMENT B: Characteriz a tion of Fluorotelomer Products and Corresponding Polymers

I. Purposes The characterization of the nine com m e rcial fluorotelom er-based products identified in Table 1 of Attachm e nt A to this Appendix (“Fluorotelom er Products”) and the corresponding synthesized or purified polym ers equivalent to the Fluorotelom er Products with respect to the chem ical com position that creates their fluorotelom er functionality (“Corresponding Polym e rs”) serves the following purposes: A. To Address the identity, purity, quantity and com position of the Fluorotelom er Products and Corresponding Polym e rs. B. To Explain the outcom e of the biodegradation studies perform e d on the Fluorotelom er Products and Corresponding Polym e rs. II. Characterization Procedures A. Analysis of Fluorotelom er Products and Corresponding Polym e rs The laboratory perform i ng characterizati on of the Fluorotelom er Products and Corresponding Polym e rs shall determ ine the m o lecular weight distribution of each Fluorotelom er Product and any Corresponding Po lym e rs. The Fluorotelom er Products and Corresponding Polym e rs shall be dissolved in AK-225G:THF. If the laboratory determ ines that AK-225G:THF is not an effective solvent, the laboratory shall use another, m o re effective, solvent. The actual solvent that the laboratory uses shall be docum ented in laboratory records and the reasoning for the alternative choice provided to EPA as part of the final report. The laboratory shall determ ine the weight percent of undissolved solids and provide such inform ation to EPA as part of the final report. The laboratory shall wash or leach the Fluorotelom er Products and any Purified Fluorotelom er Products, as that term is defined in Appendix A, using a scientifically acceptable m e thod that is approved by EPA. The laboratory shall determ ine the num ber average m o lecular weight and weight average m o lecular weight of the dissolved Fluorotel om er Products and Corresponding Polym e rs by size exclusion chrom a tography (“SEC”) pursuant to OECD Guidelines 118 ("Determ ination of the Num b er-Average Molecular W e ight and the Molecular W e ight Distribution of Polym e rs using Gel Perm eation Chrom a tography") and 119 ("Determ ination of the Low Molecular W e ight Content of a Polym e r using Gel Perm eation Chrom a tography"). The laboratory shall use Polym e thyl m e thacrylate (PMMA) or another appr opriate polym er standard. Molecular W e ight 1(MW ) of the standards m u st bracket the MW of the Fluorotelom er Products and Corresponding Polym e rs being determ ined. B. Concentration of im purities in Fluorotelom er Products and Corresponding Polym e rs The laboratory shall m easure the levels of im purities specif i ed in Table 1 of this Attachm e nt using the m o st accurate instrum e ntation and procedures as of the tim e of testing. Values shall be expressed in weight concentrations (m g analyte /kg polym er) and m o le concentrations (m ole analyte /kg polym er). The final report shall include test and reference standards, equipm ent, preparation of standards and sam p les, calibration curve with at least five standards and r2 >0.99, fortifications bracketing the sam p le concentrations, and docum entation that standard recoveries of 70 to 130% were achieved. C. Analysis of total f l uorine The laboratory shall com bust reference standards and blanks using W i ckbold torch m e thod. Mineralized inorganic fluoride (F-) shall be trapped in distilled water or aqueous sodium hydroxide. Fluoride ions shall be quantitate d with fluoride ion selective electrode or ion chrom a tography. Values shall be expressed in weight concentrations (m g /kg polym er) and m o le concentrations (m ole /kg polym er). Successful recovery of the reference standard is defined as 70-130%. Following successful recovery of the reference standard, the Fluorotelom er Products and Corresponding Polym e rs shall be com busted and total fluorine of the com busted Fluorotelom er products and Corresponding Polym e rs shall be quantified. D. W e ight percent of total carbon The laboratory shall calculate the weight percent of total carbon. E. Particle size of solid Corresponding Polym e rs W h en a Fluorotelom er Product, as a solution, is purified to form its corresponding Purified Fluorotelom er Product, it is anticipated that the Purified Fluorotelom er Product m a y be in a solid form

. If the Purified Fluorotelom er Product rem a ins as a liquid, no particle size determ ination is possible. If the Purified Fluorotelom er Product is in a solid form , it shall be ground to a uniform particle size of < 250 : m under low tem p erature conditions using liquid nitrogen. The ground Purified Fluorotelom er Product preparation will be visually inspected for uniform ity and particle size < 250 : m . This particle size will help ensure that the Purif i ed Fluorotelom er Products will be uniform ly suspended in aqueous test solutions. The pilot test shall determ ine whether the studies require addition of the test substance in solid or liquid form

.

2III. Docum e ntation A. The identity of each Fluorotelom er Product and any Corresponding Polym e rs m

u st be docum ented including: 1. Nam e of the polym eric product (including lot or batch num ber) 2. Concentration of active ingredient 3. Date of purification B. The following supporting analytical data m u st be docum ented for each Fluorotelom er Product and any Corresponding Polym e rs: 1. Equipm ent and reagents used to generate data 2. Test and reference substances 3. Preparation of standards and sam p les 4. Analytical equipm ent operating conditions 5. Calibration and analysis results 6. Calculations C. The following characterization data m u st be docum ented for each Fluorotelom er Product and any Corresponding Polym e rs, and included in the final report: 1. Ppm and m o le/kg of each im purity listed in Table 1, below. 2. Molecular weight distribution of each Fluorotelom er Product and Corresponding Polym e rs including: a. If >90% solubilized, include % of undissolved solids b. Num b er average m o lecular weight (Mn) of the polym er fraction c. W e ight average m o lecular weight (Mw) of the polym er fraction d. W e ight of fluorochem i cal charged to polym er (as m a nufactured) 3. Calculation of total carbon weight % 4. Total organic fluorine 5. Particle size inspection

3Table 1 List of Analytes Name CAS Number 6-2 Fluorotelom er Alcohol 647-42-7 8-2 Fluorotelom er Alcohol 678-39-7 10-2 Fluorotelom er Alcohol 865-86-1 8-2 Fluorotelom er ethene 21652-58-4 8-2 Fluorotelom er Iodide 2043-53-0 10-2 Fluorotelom er Iodide 2043-54-1 Perfluorooctyl Iodide 507-63-1 Perfluorodecyl Iodide 423-62-1 8-2 Fluorotelom er acrylate ( only for polyacrylates) 27905-45-9 8-2 Fluorotelom er saturated Acid 27854-31-5 8-2-Fluorotelom er 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 Fluorotelom er Acid 812-70-4 7-2 Fluorotelom er iso-ethanol 24015-83-6 7-2 Fluorotelom er unsaturated Acid 755-03-3 7-3 Fluorotelom er unsaturated Am ide 56017-64-2 PFOA telom e r 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

4APPENDIX A – BIODEGRADATION SUPPLEM ENTAL ENVIRONMENTAL PROJECT ATTACHMENT C List of Analytes Name CAS Number 6-2 Fluorotelom er Alcohol 647-42-7 8-2 Fluorotelom er Alcohol 678-39-7 10-2 Fluorotelom er Alcohol 865-86-1 8-2 Fluorotelom er ethene 21652-58-4 8-2 Fluorotelom er Iodide 2043-53-0 10-2 Fluorotelom er Iodide 2043-54-1 Perfluorooctyl Iodide 507-63-1 Perfluorodecyl Iodide 423-62-1 8-2 Fluorotelom er acrylate ( only for polyacrylates) 27905-45-9 8-2 Fluorotelom er saturated Acid 27854-31-5 8-2-Fluorotelom er 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 Fluorotelom er Acid 812-70-4 7-2 Fluorotelom er iso-ethanol 24015-83-6 7-2 Fluorotelom er unsaturated Acid 755-03-3 7-3 Fluorotelom er unsaturated Am ide 56017-64-2

1PFOA telom e r 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 im purities that the laboratory perf orm i ng the biodegradation studies detects shall be identified, and quantified, if possible. Analysis Analyses shall be conducted using the m o st accurate instrum e ntation and procedures as of the tim e of testing. It is anticipated that analytical detection lim its for the analytes will be in the sub parts per billion. All analytical data, including any estim ated or laboratory qualified values that are below quantitation lim its, and all raw data including, but not lim ited to, laboratory notebook entries, chrom a tographs, and m a ss spectra will be included in the f i nal reports and in the m onthly reports subm itted 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 com m e rcial fluorotelom er-based products identified in Table 1 of Attachm e nt A to this Appendix (“Fluorotelom er Products”) and any corresponding synthesized or purified polym ers equivalent to the Fluorotelom er Products with respect to the chem ical com position that creates their fluorotelom er functionality (“Corresponding Polym e rs”) following the guidelines for SCAS and OECD Guideline 303A provided below. Since these test m e thods were not developed to test polym er m a terials, appropriate m odifications to the protocols m a y 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, Dock et Nos. TSCA-HQ-2004-0016, RCRA-HQ 2004-0016, TSCA-HQ-2005-5001.

To purchase a copy of OECD Guideline 303, visit: w w w .oecdbookshop.org (ISBN # 9264070427). To viewa 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 viewOPPT-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 Cent er Reading Room telephone number is (202) 566–1744 and the telephone number for the OPPT Docket, w h ich 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

### I NTRODUCTION 

### 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 theNational 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 proceduresthat 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.’’



### iOPPTS 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 theinterpretation 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 chemicalto 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 O t – O c Percent Test chemical O T (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 9 5.3 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 14 

### C-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 chemicalis 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 thatare 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 maybe 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 endogenouslyfor 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 froma 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 mLof 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 controlunits, 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 isthen 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 μ m 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).



### 5APPENDIX A – BIODE GRADATI ON S U PPL EMENTAL ENVIRONMENTAL PROJECT ATT ACH MENT D: Chain of Custody Procedures for Shipping Test Substances I. Purpose In order to ensure accurate generation of test substances and da ta, DuPont and/or the laboratories used by DuPont handling test subs tances and conducting te sts and studies must follow acceptable p r ocedures that d o cum e nt a nd/or exp l ain how the tes tsubstances were packed and shipped. This Attachm e nt outlines th e m i ni m u m procedures that m u st be followed and the docum entation that m u st be retained for the study records when packing and shipping test substances. As used in this Attachm e nt , test substances include , the nine comm e r cial fluorotelom er-based products identif ied in Table 1 of Attachm e nt A to this Appendix (“Fluorotelom er Products”), corres ponding synthesized or purified polym ers equivalent to the Fluorotelomer Products with respect to the chem i cal com position that creates their fluorotelom er functionality (“Correspondi ng Polym e rs”), and other chem icals. II. Test Substance Iden tif ic ation Before a test substance can be shipped, each test s ubstance m u st have a un ique identification num b er and this num ber must be entered on th e chain of custody for m and test substance inform ation for m . DuPont or the laboratory pr eparing or providing th e test substance must provide the nam e of the test substance, the id entif ication number and the date by which the test substance w ill b e ready f o r shipm e nt eithe r to EP A or to another th ird part y labo rato r y, 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 labo ratory, with the test substance inf o rm ation f o rm . The identif ica tion num b er ser v es to re la te the te st subs tance with inf o rm ation on the ac tivities and con d itions tha tf u llydescribe the origin of the test substance. Test substan ce iden tif ica tion wi ll also include a project numbe r in ord e r to link the te st substance w ith a specific study. III. Packaging T e st Substances For test subs tances that are not regulated by DOT, place the vo lum e of each test sub s tance specified by the study protocol in to duplicate containers appropriate for shipm e nt. Double-bag each test sub s tance, us in g zip-lock plastic ba gs. Com p lete th e Identification Sheet for the study records. For test subs tances that are re gulated by DOT, ship in separate 30 m L contain e rs and use the n u m b ering sy stem as specified above. Also includ e on each label num b er X of total num be r Y. IV. Shipping to Laboratories and to EPA A. Packing Each tes tsu bstance sho u ld be lab e le d withthe id entif ica tion nu m b er. Fluorotelom er Products and Corresponding Polym e rs should no t be shipped in the sam e package to reduce the potential for contam ination. To avoid contam ination, sam p ling equipm ent and

Page 1 o f 3containers m a de from fluoropolym ers s hould be avoided. Carefully cleaned polypropylene and polystyrene sam p le contai ners and centrifuge tubes have been satisfactorily used for the analysis of fluor inated com pounds. However, all containers that com e in contact with treated and untreated test substances m u st be confirm e d to be free of PFOA. Containers that are not fr ee of PFOA should be triple washed in high purity o r gan i c solv ent, i. e. , m e thanol, aceton itrile or isoprop anol, and reconfirm e d to be free of PFOA before use. The use of disposab le labware is recommended, i.e., pipets. The contain e rs should b e placed in a zip-lock plastic b a g that is lab e led with the test substance Id entif ica tion Num b er and Project Number as descri bed above. Be sure that the bag is tightly closed and puncture-free. Pl ace the label with the identification number, project number and lot num b er 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 shipm e nt requirem e nts. B. Mater i al Sa fety Data S h eets Appropriate MSD sheets should be included. Ensure that th e MSD sheet can be rem o ved from the box without disturb i ng the packi ng contents. Place th e MSD sheet in an envelope an d place th e envelope on top of the test subs tances in the bo x. The chain of custody form m u st also be placed in the box. C. Shipping Papers The chain of custody form serves as a packi ng list for the shipm e nt and to docum ent the contents of the shipm e nt. It m u st accurately re f l e c t the conten ts of th e shipm e nt. It is to be includ ed in the package with the test substance(s). Each chain of custody form must include the following: -Projec t number -Unique tes t substance nu m b er of each tes tsubstance in the s h ipm e nt -Unique shipm e nt num ber -Signature of investigator responsible fo r test substances and date on which the shipm e nt left this person’s custody The packer of the shipment has the responsibil ity to verify that th e test substance listed on the chain of custody form corresponds to th e test substance actua lly shipped and that the test substance descri ption on th e chain of custody for m is accurate. A ny discrepancies m u st be rectified befo re the test substance is shipped. The chain of custody form m u st be placed in the box. Place the chain of custody form in an envelope and place th e envelope o nt op of the test subs tances in th e box

. D. Commercia l Air Deliv ery Service Ship each package using a door-to

- do or carrier so that the pack age/ articles will arriv e during the norm al 5-day workweek. Do not ship packages if the arr i val d a te does no t f a ll on a business work day.

Page 2 o f 3E. Airbills /Bill-of Lading A separate Airbill or th e like is pr ef erred for each shipm e nt num b er, even if several different shipm e nt num bers are sen tat the sam e tim e. In this way, one Airbill can be associated w ith one shipm e nt num b e r . If this is n o t prac tic al, at le ast c l ear l y indicate o n the Airb ill e ach shipm e nt num ber that was inc l ud ed in the shipm e nt. A space is g e nerally provided by the shipper for special notations. When sam p les are surren d ered to a carrier , docum entation m u st be obtained from the carrier such as a copy of the Airb ill o r Bill -of-Lading that ind i cates that th e chain of custody of the shipm e nt has been transferred to the carrier. This document m u st bear the shipm e nt number, the carrier’s nam e , the date of transfer of custody, and signature of the sender. This docum entation m u st be retained and becom e pa rt of the study records. Retain th e o r igin al Airb ill f o r the stu dy records. F. Shipment Notification Imm e diately upon shipment, notif y the recipient and include: Date of Shipm e nt Carrie r Overnight or Two-day delivery Date of Anticipated Arrival Tracking Number Approxim a te Size of Package Approxim a te W e ight of Package Type of Test Substance

Page 3 o f 3

# Quality Quality Quality United States Office of Environmental EPA/240/B-01/003 Environmental Protection Information March 2001 Agency Washington, DC 20460 

# EP A Requirements for Quality Assurance Project Plans EP A QA/R-5FOREWORD 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

Final EPA QA/R-5 i March 2001ACKNOWLEDGMENTS 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 2001TABLE 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 Final EPA QA/R-5 iii March 2001Page 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

Final EPA QA/R-5 iv March 2001CHAPTER 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 2001includes 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 Final EPA QA/R-5 2 March 2001ORGANIZATION/PROGRAMPROJECTPOLICY

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

IMPLEMENTATION PLANNING 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 2001Quality 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 2001C 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(This page is intentionally blank.)

Final EPA QA/R-5 6 March 2001CHAPTER 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, workassignments, 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 2001those 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 manager 1 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 2001Plan. 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, EPAmay 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 2001CHAPTER 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 2001The 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

Final EPA QA/R-5 12 March 2001that 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 2001Section 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.

Final EPA QA/R-5 14 March 20013.2.7 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;

Final EPA QA/R-5 15 March 2001C 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. Final EPA QA/R-5 16 March 20013.3.2 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

Final EPA QA/R-5 17 March 2001method 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 Final EPA QA/R-5 18 March 2001specified 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 Final EPA QA/R-5 19 March 2001Transmission 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 2001problems 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 MethodsDescribe 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.

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Final EPA QA/R-5 22 March 2001REFERENCES 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 2001U.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 2001APPENDIX 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 2001QAMS-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 2001A.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 2001Elements 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 2001Elements 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 verifyingand 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

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Final EPA QA/R-5 A-6 March 2001APPENDIX 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 2001environmental 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 2001management 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 2001staff, 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 2001APPENDIX A – BIODEGRADATION SUPPLEM ENTAL 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 • De ns i t y ( g •m L ) g• mL
• Weight percent solids (w t% solids) w t %

• Weight percent active ingredient (w t% a.i.) w t %

• 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• m g-1* nmol• m g-1 * 6-2 Fluorotelom er Alcohol 647-42-7 8-2 Fluorotelom er Alcohol 678-39-7 10-2 Fluorotelom er Alcohol 865-86-1 8-2 Fluorotelom er ethene 21652-58-4 8-2 Fluorotelom er Iodide 2043-53-0 10-2 Fluorotelom er Iodide 2043-54-1 Perfluorooctyl Iodide 507-63-1 Perfluorodecyl Iodide 423-62-1 8-2 Fluorotelom er acrylate (only for polyacrylates) 27905-45-9

18-2 Fluorotelom er saturated Acid 27854-31-5 8-2-Fluorotelom er 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 Fluorotelom er Acid 812-70-4 7-2 Fluorotelom er iso-ethanol 24015-83-6 7-2 Fluorotelom er unsaturated Acid 755-03-3

7-3 Fluorotelom er unsaturated Am ide 56017-64-2

PFOA telom e r 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: _________________

2APPENDIX A – BIODEGRADATION SUPPLEM ENTAL ENVIRONMENTAL PROJECT ATTACHMENT G: List of Laboratories for Biodegradation and Characteriz a tion Biodegradation Laboratories Springborn Sm ithers Laboratories Massachusetts Research Center 790 Main Street W a reham , MA 02571 Phone (508) 295-2550 Fax (508) 295-8107 http://www.springbornsm ithers.com / sim ltest.htm l ABC Laboratories, Inc. 7200 E. ABC Lane Colum b ia, Missouri 65202 USA (573) 443 9000 Telephone (573) 443 9033 Facsim ile http://www.abclabs.com / cd/fate/fate_biodeg_m etabolism

. HTM W ildlif e International 8598 Com m e rce 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 Facsim ile: 814.272.1019 Em ail: info@exygen.com <m ailto: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 Pharm aceutical Services 3 Innovation W a y, 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 Ch em istry and Green Chem istry Program that Respondent E.I. du Pont de Ne m ours and Com p any ( “ DuPont” or “the Company”) will im ple m ent in five junior high schools and thre e high schools in the publ ic school system of Wood County, W e st Virginia. [Schools nam e d in a ttachm e nt 1 to this docum e nt.] The program will be im pl em ented as a Supplem e n tal Environ m enta l Project (“SEP”) p u rsuant to Section III of the Consent Agreem ent and Final Order (“CAFO”). This SEP is subje c t to the applicab le te rm s and conditions specified in the CAFO and to th e additional specifications set forth in this Appendix. The effective date of this SEP is th e sam e as the effective date of the CAFO. The goals of this SEP are to (1) reduce the adverse im pact to public health by m i nim i zing the potential exposure to chem icals in schools, (2 ) reduce the adverse im p act to the environm ent in and around W ood County, W e st Virginia by m i nim i zing disposal of hazardous waste generated at schools and (3) enhan ce science safety in all of thes e schools (hereinafter referred to as “the SEP Goals.” The total co st of this SE P is one m illion two hundred fifty th ousand dollars ($1,250,0 00). DuPont plans to engage Education P l anning & Oversight, Dover, Delaware, (“EPO”) to lead the design and adm i nistration of th is SEP and act as project m a nager. The im ple m entation of this SEP will invol ve close coordination between EPO and the teachers and adm i nistrators in th e participati ng schools. The W ood Coun ty school d i strict m a y wish to m o dif y certa in a s pects of th is SEP inorder to best accommodate local resources and objectives (if, for exa m ple, the district converts curre nt junior high schools to grade 6-9 m i ddle schools) bu t such m odifi cation s will al ways m a intain the SEP Goals. Consequently, EPA and DuPont reco gnize and ag ree th at th is SEP will be im plem ented flexibly although rem a in consistent with the SE P Goals. DuPont m a y request adjustm e nts of the schedules an d will inf o r

mEPA of SEP im plem en tation in de tailed prog re ss reports. EPA and DuPont reco gnize th at th e schedules for im plem entation of each Program of this SEP set forth in the following work plan are good faith estim at es that depend on, am ong ot her things, tim ely actions and responses by third parties in W ood County, WV a nd the pa rticipating schools, includ ing adm i nistrators and teach ers . 12 DuPont agrees that the cost of EPO’s serv ices 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 co sts of substitute teachers to cover instructional time during teacher training periods) as a result of participating in SEP act ivities, and would not otherwise incur, and that this compensati on will be an allowable cost of the SEP

. It is understood that this SEP does not require DuPont to und ertake any action that would render DuPont liable to any person for persona l injury, property damage, economic loss or any other claim whatsoever. Work Plan and Schedule Microscale Chemistry & Green Chemis try Program in Wood County, WV Microscale chemistry reduces risk by reducing exposure to chemicals. Microscale involves using very small, pre-measured quanti ties of chemicals when conducting experiments in the 7-12 science classroom. This approach is associated with pre-packaged consumable materials for science education. The ke y feature of these materials is the use of nominal amounts of chemicals, often in pre-measured devices th at allow a student to pa rticipate 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 su ch substances is reduced by cont rolling 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 st udent labs is called a “clo ck reaction.” In such a reaction, a sudden color change occurs when the reaction is complete. Th e color change allows students to measure reaction time. Instead of us ing formaldehyde or bisulf ites 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 ove rview 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 sch ool district, EPO will assi st in the development of a plan for implementation of instructional units, modules, and activities using pre-packaged (micro-scale and small scale) consumable materi als, whether purchased from science materials vendors or refurbished through the sc hool 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 member s representing school3 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 enco mpassing the five elements of education enhancement: curriculum selection; teacher pr ofessional 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 equivale nt, or EPO will design a 3-4 day planning meeting during which SPLT will write a draft Strategic Plan

. EPO anticipates that these strategic planni ng activities will requi re 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 wi ll 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 remai nder 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 hi gh 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 ac tivities using pre-pack aged (micro-scale and small-scale) consumable materials. Curriculum Selection Committee : EPO will conduct a Curriculum Selection workshop(s) to introduce the district to Nati onal 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 Technol ogy for Children), and SEPUP (The Science Education for Public Understanding Program) ─ and those approved for high school use in high school science classes where chemi cals are used (which are set forth in Attachment 2 to this SEP). The Curriculum Selection Committee will sele ct 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 catalogu ing, distributing, and refurbishing materials. The Committ ee will develop a budget for ongoing operation. Professional Development Committee : During Years 1 and 2, out side consultants (i.e., science specialists from ot her school districts and/or kit vendors or materials publishers) will provide professional development for Lead Teache rs. Following the initia l phase of professional development, Lead Teachers and district sc ience 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 professi onal development of all teachers4 of science in the district that enables them to use the mate rials 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 sc hool district approves th e 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 e ffective date of the CAFO. Th is 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 expend itures 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 chemistr y concepts and (b) use of one micro-scale chemistry curricular unit or module at their grade level, to be provi ded. School principals will be strongly urged to attend these workshops. EPO w ill conduct a formative evaluation of the initial professional development workshops. Th e 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 curr icular scope and sequence within grades 7-12). EPO will organize 2 peer observation and reflec tion 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 pe rmanent Steering Committee charged with ongoing implementation of the inte rvention 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 pr ogram to date, and a pr ojection 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 chem istry 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 wi ll write a plan for teacher professional development related to formative assessm ent 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 EP A at the completion of these activities but not later than 3 years of the effective date of th e CAFO, that will be the fi nal 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 e ffective 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 CA FO 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 m eetings, training and other activities occurring under this SEP and EPA will be entitled to monito r or participate in any such meetings, training or other activities, provided that such activities do not interfer e 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 Pl an 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 schedu le above or cannot be co mpleted 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 ac tivities, provided that DuPont shall not be required to spend more than $1,250,000 in eligible cost s 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 estima te. 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-concurrenc e, 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.N ATIONAL S CIENCE F OUNDATION -F UNDED S CIENCE I NSTRUCTIONAL M ATERIALS 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 (C 3 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 Appro ach 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 & Sustainabi lity 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 Workpl ace 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 34 th 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 31 st Street Parkersburg, WV 26104 Phone: 304-420-9645 Fax: 304-420-9647 Principal: Mr. Steven Taylor E-mail: staylor@access.k12.wv.us Enrollment: 380High 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 5 th 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