Document 108b0kvvxk76e58V0RNV9Ln3j

' 3M Specialty Materials Fil-W ' /37S3M Center St. Paul, MN 55144-1000 651 733 1100 if f May 26, 2000 3M Dr. Charles Auer, Director Chemical Control Division Office of Pollution Prevention and Toxics United States Environmental Protection Agency 401 M Street, Southwest Room 403, East Tower (Mail Code 7405) Washington, D.C. 20460 FYI-00-001378 FYI-0 0 -0 0 3 7 0 Dear Charlie: I wanted to follow-up on recent discussions regarding 3M's voluntary effort to provide EPA with information on perfluorooctane sulfonates and related compounds. Initially, it may be useful to review the information that 3M already has provided in the last month: *April 20, 2000: Letter to Oscar Hernandez enclosing additional materials relating to the two-generation reproductive study and related studies on perfluorooctane sulfonates. (Materials also submitted separately to the TSCA Section 8(e) docket). Cq *April 21, 2000: Letter to Charlie Auer enclosing health effects studies on perfluorooctane sulfonates relating to the following areas: (i) pharmacokinetics; (ii) teratology; and (iii) epidemiology and medical surveillance. *April 28, 2000: Letter to Oscar Hernandez enclosing Use Exposure Information Profile (UEIP) for perfluorooctane sulfonates. *May 3, 2000: Letter to Dr. Jennifer Seed from John Butenhoff conveying analyses of PFOS in serum from two pharmacokinetic studies. *May 4, 2000: Letter to Charlie Auer enclosing information on perfluorooctane sulfonates as follows: (i) Copies of post-1975 environmental science studies along with a robust summary for each study; executive summaries for each environmental science sub-area and a detailed index; (ii) Copies of post-1975 health effects studies along with a detailed index; (iii) Lists of all PFOS studies planned or in progress along with protocols/study plans, where available; (iv) Bibliographies of pre-1976 studies and non-key acute toxicity studies; and (v) An index of all perfluorochemical-related submissions to the TSCA Section 8(e) docket. 85000000017 8500000001? 0~"tG73m3o \.o -H p n O m<L.W oo C3 rv> Page 2 Dr. Charles Auer, Director *May 11, 2000: Letter to Charlie Auer enclosing information on the different applications for perfluorooctane sulfonates and on composition of certain perfluorooctane sulfonates-containing products. *May 12, 2000: Letter to Charlie Auer enclosing additional data on wildlife measurements of perfluorooctane sulfonates and related compounds. *May 15, 2000: Letter to Charlie Auer providing summaries for certain studies included in the May 4, 2000 package of materials. *May 18, 2000: Letter to Charlie Auer enclosing additional perfluorooctane sulfonates studies located subsequent to the May 4, 2000 package of materials as well as health effects and environmental science studies on 13 related compounds listed in Table 1 of the document entitled: "Sulfonated Perfluorochemicals In The Environment: Sources, Dispersion, Fate And Effects", at 12 (March 1, 2000). The May 18, 2000 package of materials included robust summaries and detailed indices similar to the May 4, 2000 package. *May 26, 2000: Letter to Charlie Auer enclosing environmental science and health effects studies and other information on perfluorooctanoic acid (PFOA) as well as supplemental information on perfluorooctane sulfonates and related compounds. 3M's fde review is continuing, and we will supplement the areas already covered in these previous packages of materials as appropriate. What I am hoping to clarify with you, however, is the path forward for providing information on other areas where EPA has expressed an interest. To this end, 3M would propose the following schedule: *May 31, 2000: UEIPs for the 13 perfluorooctane sulfonates-related compounds listed in Table 1 of the document entitled: "Sulfonated Perfluorochemicals In The Environment: Sources, Dispersion, Fate And Effects", at 12 (March 1, 2000). *June 9, 2000: UEIP for PFOA and environmental science and health effects studies and other information on mixtures containing PFOS. For purposes of this submittal, we are applying a definition of "mixtures" where PFOS is an intentional component of the mixture. Page 3 Dr. Charles Auer, Director We continue to work diligently to provide EPA with the information requested in as timely a manner as possible and in a format that is effective for the agency's review. We will continue to use our best judgement in providing this information to EPA, including consideration of the human effort involved in completing this task. 3M has discussed with you the question of environmental science and health effects studies on mixtures containing the 13 PFOS-related compounds. It is 3M's recommendation that such studies not be provided to EPA at this time for several reasons. First, the vast majority of these studies do not involve products in current (or even recent) commercialization. Second, many of these studies are acute studies and would not qualify as "key studies". Third, being mixtures, it is difficult to determine the contribution of the fluorochemical on toxicity in any given study. Finally, the process of identifying, reviewing, cataloguing and copying all such mixture studies in 3M's files would involve an extraordinary effort at a time when we are very involved in executing our business decision regarding the manufacture of perfluorooctanyl chemistry. I would like to suggest that 3M focus specifically on completing the submission of data on PFOS, the identified chemistries made from POSF, and PFOA. 3M will then submit to EPA information on studies regarding mixtures containing PFOS specifically before the end of June. 3M would like the agency to first review the data on mixtures containing PFOS and assess the utility of such information before requesting the submission of data on mixtures containing the 13 PFOS-related compounds. At that time we would be pleased to discuss approaches and a timetable for providing such information. Please give me or Mike Nash of 3M (651-733-0134) or Julie Hatcher of Latham & Watkins (202637-2238) a call to discuss this matter. In the meantime, 3M will proceed in accordance with the foregoing schedule. Best regards, William A. Weppner, Ph.D. Director Environmental, Health, Safety & Regulatory Affairs Specialty Material Markets Group 3M Center, Building 236-1B-10 St. Paul, MN 55144-1000 3