Document VKE46Yw4nge830w0KbNekqg5q

3M General Offices 3M Center St. Paul, MN 55144-1000 651 733 1110 August 21,2000 C O N FID EN TIA L - FO R S E TTLE M E N T PURPO SES O N LY Mr. Jesse Baskerville Director, Toxics &Pesticides Enforcement Division U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, N. W. Suite 4109 Washington D C. 20044 Re 3M C o m p a n y T S C A S e c tio n 8 (e ) C o m p lia n c e A u d it - D isclosure O f Phase One Findings P ursuant To "Incentives For S elf-P o licing, Discovery, D isclo su re And C o rrection A nd P revention O f V iolations," 65 Fed. R eg. 19618 (Apr. 11, 2000) Dear Mr. Baskerville: Pursuant toour recent conversation with Mr. Gerry Stubbs andothers fromyour staff, 3MCompany ("3M") is writing todisclose potential violations ofTSCA Section 8 (e)'s "substantial risk" reporting requirements pursuant to EPA's Self-Audit Policy. See "Incentives For Self-Policing, Discovery, Disclosure And Correction And Prevention OfViolations," 65 Fed. Reg. 19618 (Apr. 11, 2000). We appreciated the opportunitytospeak with Mr. Stubbs and the others and theirwillingness toarrange a meeting with 3Mtodiscuss this matter further. 3Mis anxious toarrange ameeting as soon as possible, but has experienced difficulty infinding a mutually convenient time due tosummer vacation schedules. 3Mwould like topropose either September 11 or 13 as meeting dares. We will contact Mr. Stubbs inhopes of confirming a meeting. In this letter, 3Mwould like toreviewthe background and context for theTSCA Section 8 (e) compliance audit under which the potential violations were discovered; toreview the specifics ofthe potential violations; andtoclose with proposed topics for our upcoming meeting. I. A U D IT S C O P E . B A C K G R O U N D A N D C O N T E X T 3Mis conducting a systematic and comprehensive TSCA Section 8(e) compliance audit. 3Mhas retained outside counsel fromLatham&Watkins tomanage M a d e A vailab le by 3 M for Inspection and C opying as C onfidential Inform ation: S u b je c t to P ro tective O rd e r In P a lm e r v. 3 M , N o. C 2 -0 4 -6 3 0 9 3M A 01220040 Mr. Jesse Baskerville August 21,2000 Page 3 => P h a s e Tw o The second phase of the audit will address the remaining FYI Submissions, which include studies and information on PFOS mixtures as well as additional studies and information on PFOS, the PFOS-related compounds and PFOA. 3Malready has commenced the second phase of the audit and expects tocomplete this phase of the audit by October 1, 2000 or shortly thereafter. => P h a s e T h ree In light ofthe phase one results, 3Mhas decided to performa third phase of the audit toaddress studies and information not encompassed by the FYI Submissions. For the most part, phase threewill focus on non-FC studies and information, but it may also include other materials relating to FCs not covered bythe FYI Submissions, such as, for example, studies and information onperfluorocarbon gases. Although scoping for phase three is not yet complete, 3Manticipates that phase three could involve as many studies and pieces of information as thefirst two phases of the audit combined, andthus, may require additional time and resources. 3Mhas targeted tocomplete phase three by March of 2001. As we indicated to Mr. Stubbs andthe others inour recent telephone conversation, there is some background behind3M's decision toundertake the audit and tofocus initially onthe FYI Submissions. Although we lookforward toprovidingthe details at our meeting, some preliminary background may be useful inadvance of the meeting. 3Mhas been involved inan ongoing dialogue with Dr. Charlie Auer, Dr. Oscar Hernandez and others fromOPPT for nearly two years regarding FCs. This dialogue stems froma series ofTSCA Section 8(e) submissions by 3Mbeginning in May of 1998, which reported the measurement of PFOS and other FCs ingeneral population human serumand inwildlife at lowparts per billion (ppb) levels. The measurement of PFOS and other fluorochemicals at such lowlevels became possible only due tostate-of-the-art analytical developments. 3Mhad previously reportedtothe TSCA Section 8(e) docket the detection of FCs inthe serumof its production workers at lowparts per million (ppm) levels Early on inthis dialogue, 3Msubmitted a paper toOPPT inJanuary of 1999 - often referred toas the "Health Effects White Paper" --which summarized the toxicological, epidemiology and serumdata on PFOS and provided a risk characterization based onthese data.4 OPPT placed this White Paper intotheTSCA Section 8 (e) docket as a supplement tothe FC-related docket numbers 373/374. In "Perfluorooctane Sulfonate: Current Summary Of Human Serum'Health & Toxicology Data" (January 1999) (contained in TSCA 8(e) docket number 8EHQ-0299-373). M a d e A vailab le by 3 M fo r Inspection and C opying as C onfidential Inform ation: S u b je c t to P ro te c tiv e O rd e r In P a lm e r v. 3 M , No. C 2 -0 4 -6 3 0 9 3MA01220041 Mr. Jesse Baskervilie August 21, 2000 Page 4 March of 2000, 3Msubmitted as a supplement tothese same docket numbers a paper --often referredtoas the "Environmental White Paper" ~which summarized the environmental fate and effects data on PFOS and other FCs.5 Both of these White Papers were intended by 3Mtofacilitate OPPT's consideration of FCs. As discussed further inSection II beiow, theWhite Papers review either the specific data or similar data for all of the 30 studies identified by 3Mas potentially reportable under the current EPA guidance. Inlate March 2000. Dr. Auer requested that 3Mmake available additional studies and other information on FCs not previously submitted tothe TSCA Section 8 (e) docket. The FYI Submissions comprise 3M's voluntary response tothis request. The first FYI Submission occurred onApril 21.2000, and submissions have occurred thereafter ona periodic basis under an informal schedule. 3M's file search is continuing, and at least one more submission will occur at the end ofAugust 2000. Shortly after thefirst FYI Submission, 3Minitiatedthe current TSCA Section 8(e) compliance audit. Over the years, 3Mhas made a significant number of TSCA Section 8(e) submissions on FCs. Nevertheless, questions have arisen about the application of EPA's TSCA Section 8 (e) reporting guidance to some of the studies and information inthe FYI Submissions as well as about which of these studies and information had been either published or made available toEPA through other reporting mechanisms, such as FIFRA registration. 3Mfelt that it was important under the circumstances toundertake a retrospective assessment of all of the studies and information inthe FYI Submissions against EPA's current TSCA 8 (e) reporting guidance and toplace into the 8 (e) docket any material that potentially meets the reporting guidance . Other notable FC-related developments have occurred inrecent months. 3Mannounced on May 16, 2000 its intention substantially tophase out production of all perfiuorooctanyl-based chemistries - including PFOS, PFOA and the other FCs addressed by the FYI Submissions --by theend of 2000. 3Mmade this decision because of its commitment toresponsible environmental management and sound business principles. -3Mhas continued towork with OPPT since its May 16, 2000 announcement onthe specifics of the phase out plan. Inaddition, 3Mis currently preparing a screening level risk assessment for PFOS incoordination with OPPT and other regulators through the Organization For Economic And Community Development ("OECD"). ' "Sulfonated Perfluorochemicals In The Environment: Sources, Dispersion, Fate And Effects" (March 2000) (contained in 8(e) docket number 8EHQ-0300-0373). M a d e A vailable by 3 M fo r Inspection and C opying as C onfidential Inform ationS u b je c t to P ro te c tiv e O rd e r In P a lm e r v. 3 M , N o. C 2 -0 4 -6 3 0 9 3MA01220042 Mr. Jesse Baskerville August 21,2000 Page 5 II. D IS C L O S U R E O F P H A S E O N E A U D IT R E S U L T S Phase one ofthe audit was completed on July 31, 2000. Based onthe audit findings and recommendations, 3Mhas submitted a request that EPA redesignate 30 studies (or pieces of information) out ofthe over 600 studies nowcontained inFYI Docket Number 1378 as a supplement totheTSCA Section 8 (e) dockets for PFOS and related FCs - Docket Numbers 373/374. (See Attachment A). Inour upcoming meeting, 3Mwould like totake the opportunity toreview the details ofour audit protocol and results andtoaddress any specific questions that theAgency may have regarding the audit. As background prior toour meeting, it is important toemphasize that 3Mhas submitted a substantial body of data on FCs tothe TSCA Section 8 (e) docket over the years. These submissions reflect the seriousness with which 3Mregards its reporting obligation. We have voluntarily augmented these data throughthe January 1999 Health Effects White Paper, the March 2000 Environmental White Paper andthe extensive FYI Submissions. Out ofthe over 600 FC studies audited so far inphase one, 3Midentified 30 studies that appear potentially reportable under a strict application of the current EPA guidance. In all cases, these 30 studies are consistent with prior 8 (e) submissions and information inthe published literature; also, some of these studies are of questionable reliability, and in several cases, subsequently have been (or are being) performed under more sound methods. Nevertheless, it appears that these studies may not qualify, strictly speaking, as "corroborative" or "unreliable" under current EPA guidance, and for this reason, may qualify as potentially reportable under the guidance. To place these studies infurther perspective, 3Mreviews the studies belowon a categorical basis. => -A n im a l D a ta A c u te T o x ic ity Four acute toxicity studies appear potentially to meet EPA's current reportingguidance. All four of these studies fall intothe "moderate" toxicity category under EPA's reportingguidance. These data are consistent with published data and/or previous 8 (e) submissions on other, structurally similar FCs. For example, one study addresses the acute toxicity of one formof PFOS, whereas comparable published acute toxicity data are for a salt formof PFOS. Moreover, acute toxicity data were included intheJanuary 1999 Health Effects White Paper placed by OPPT inthe 373/373 8 (e) dockets. => -A n im a l D a ta S u b c h ro n ic a n d C h ro n ic T o x ic ity Four studies appear potentially tomeet EPA's current reporting guidance due toliver weight changes and liver effects. Three of these four studies are on PFOS, andthe data is consistent with previous 8 (e) submissions and/or published information on PFOS. Moreover, toxicology data on PFOS, including liver weight changes and liver effects, were addressed inthe January 1999 Health Effects White Paper. Similarly, thefourth study is on N-methyl FOSE, which is structurally similar toN- M ad e A vailab le by 3 M fo r Inspection and C opying as C onfidential Inform ation: S u b je c t to P ro te c tiv e O rd e r In P a lm e r v. 3 M , N o. C 2 -0 4 -6 3 0 9 3M A 01220043 Mr. Jesse Baskerville August 21,2000 Page 6 ethyl FOSE, for which 3Mhas already submitted information totheTSCA Section 8(e) docket showing comparable effects. => A n im a l D a ta -- N e u ro to x ic ity . Two studies --a two-week rangefinding study on PFOS inrats and a 28-day study on N-ethyl FOSE inrats --appear potentially to meet EPA's current reporting guidance due tothe observation of effects identified inthe guidance as being potential indicators of neurotoxicity. The extensive data base on both PFOS and N-ethyl FOSE suggests, however, that neither of these compounds is a neurotoxin. => -A n im a t D a ta D e v e lo p m e n ta l T o x ic ity Four studies --one study on PFOS in rabbits and three studies on N-ethyl FOSE - appear potentiallytomeet EPA's current reportingguidance due tothe observation of developmental effects, even though these effects occurred inconjunctionwith maternal toxicity. The January 1999 Health Effects White Paper reviewed some of this data as well as similar data: prior 8(e) submissions also have covered similar data onthese chemicals. => A n im a l D a ta - D e rm a l/E y e Irrita tio n Four studies - one on PFOS; one on Nethyl FOSE; and two on PFOA-related compounds -- appear potentiallytomeet EPA's current reporting guidance duetoobservation of continued irritation effects 21 days after cessation of dosing. Prior 8(e) submissions have covered similar data onthese and other FCs. => A n im a l T o x ic ity - P h a r m a c o k in e tic s A n d :M e ta b o lis m Two studies appear potentially tomeet EPA's current reporting guidance: one study showing the half life of PFOS in rabbits tobe greaterthan one month and one study showing PFOS as a metabolite of N-ethyl FOSE inrats. Previous 8 (e) submissions have addressed bothof these specific aspects of FC metabolism; these aspects of FC metabolismalso were discussed indepth inthe January 1999 Health Effects White Paper. => H u m a n S e ru m D ata: 3Mhas made 8 (e) submissions of human serumdata over the years. Most recently, as indicated above, 3Mreported inMay of 1998 its finding of PFOS ingeneral population human serum; this May of 1998 report was followed by a detailed summary of PFOS toxicology, medical surveillance, epidemeology and serumdata inthe January 1999 Health Effects White Paper. 3Mmade afurther 8 (e) submission with human serum data on PFOS and other FCs inMay of 1999. Nevertheless, twoadditional pieces of serumdata obtained subsequent tothe May 1999 Submission - a 1999 analytical report on measurements of FC metabolites in3Mworker serumand a 1999 analytical report onmeasurements of FCs inserumsamples fromten children --appear M a d e A vailab le by 3 M fo r Inspection and C opying as C onfidential Inform ation: S u b je c t to P ro te c tiv e O rd e r In P a lm e r v. 3 M , N o. C 2 -0 4 -6 3 0 9 3MA01220044 Mr. Jesse Baskerville August 21, 2000 Page 7 potentially reportable under EPA's current guidance because these data are not, strictly speaking, "corroborative" of prior submissions. => E n v iro n m e n ta l F a te D ata: 3M's May of 1998 8 (e) submission with the human serumdata also included data onthe measurement of PFOS inblood bank animal serum. Subsequently, inMay of 1999, 3Mmade a supplemental 8 (e) submission that included measurements of PFOS inthe serumofwildlife species. The March 2000 Environmental White Paper also provided a detailed reviewof the animal serumdata. Nevertheless, twoadditional pieces of serum data - the 1999finding of certain FCs innaive rats and the 2000 finding of FCs inadditional wildlife species - appear potentially reportable under the EPA guidance. Inaddition, six environmental fate studies on FCs --four studies from various years measuring an n-octanol/water partitioning coefficient for N-ethyl FOSE and N-methyl FOSE; one study detecting N-ethyl FOSE ina limited number of fish fromthe Tennessee River; and one study detecting N-ethyl FOSE invarious fish tissues under experimental conditions --appear potentially reportable under the EPA guidance. Notably, all ofthese studies are of questionable reliability, and 3Mis currently conducting state-of-the-art studies to measure an n-octanol/water partitioning coefficient for these compounds. => E n v iro n m e n ta l T o x ic ity D ata: One recent acute toxicity study of PFOS in bobwhite produced an LC50 at the "high" toxicity category under EPA's current reporting guidance. Although the draft results fromthis studywere included in the March 2000 Environmental White Paper, this study was never identified with particularity inany 8(e) submission. III. N E X T S T E P S 3Mhas requested the opportunity tomeet with the Agency. We believe that a meetingwould provide the opportunitytoaddress two principal aspects ofthis matter. First, 3Mhas endeavored toconduct this audit inaccordancewiththe Self-Audit Policy. Given the breadth of 3M's audit, we believe that it is important to develop an understanding of howthe Self-Audit Policy applies toour effort andtoagree with theAgency ona process for self-reporting onfuture phases ofthe audit under the Self-Audit Policy. As we discussed with Mr. Stubbs and others, 3Mhas been operating over the last one and one-half years under an agreement that provides for auditing of TSCA systems and of PMNnomenclature. (See Attachment B). This agreement expired on July 24, 2000. 3Mdidnot initiate its current TSCA Section 8 (e) compliance audit under this agreement forthe principal reason that this agreement does not seem tocontemplate extensive TSCA Section 8 (e) compliance auditing, but rather, onlyTSCA systems audits with compliance "sampling" tobolster those audits. Thus, 3Minitiated M a d e A vailab le by 3 M fo r Inspection and C opying as C onfidential Inform ation: S u b je c t to P ro te c tiv e O rd e r In P a lm e r v. 3 M , No. C 2 -0 4 -6 3 0 9 3MA01220045 Mr. Jesse Baskerville August 21, 2000 Page 8 the current compliance audit under the Self-Audit Policy as opposed tothis agreement. Nevertheless, 3Mbelieves that this agreement epitomizes the cooperative approach that 3Mwould like topursue for this matter and provides a model togovern the compliance audit. Second, 3Mwould like touse our meeting toprovidefurther details tothe Agency onthe FC context for the audit. As we mentioned toMr. Stubbs andthe others, Dr. Auer and Dr. Hernandez fromOPPT, inparticular, also may be able toprovide useful background inthis regard. Their attendance at the meeting may be beneficial. Thank you againfor yourwillingness tomeet with 3Mregarding this matter. As we prepare for the meeting, please use our outside counsel fromLatham& Watkins, Julie Hatcher, as your central point of contact. You also shouldfeel free to direct any questions regarding this matter toJulie, who can be reached at (202) 637 2238. ' ~ `' Very truly yours, W. ^ j Katherine E. Reed, Ph.D Executive Director Environmental Technology and Safety Services Enclosure cc: Gerald B. Stubbs, Chief, Case Development, Policy and Enforcement Branch Julia A. Hatcher, Esq. DC_DOCS\321116.2 6vrw02I.DOC |W97] M ad e A vailab le by 3 M fo r Inspection and C opying as C onfidential Inform ation: S u b je c t to P ro te c tiv e O rd e r In P a lm e r v. 3 M , N o. C 2 -0 4 -6 3 0 9 3MA01220046