Document nmZ079Gg25xEaoo7R305xEEO1

31VI General Offices April 21, 2000 3M Center St. Paul, MN 55144-1000 612 733 1110 Dr. Charles Auer Room 7405 US EPA Headquarters Ariel Rios Bldg. 1200 Pennsylvania Avenue, N. W. Washington, D. C. 20460 Dear Charlie: R <7 A R ttfe-0003 v- ' C-7- S1 U) ~--'J.3bo i -1P1 o --r .'* c r. Pursuant to our recent communications, 3M is enclosing additional information relating to perfluorooctanesulfonate (PFOS). We are providing this information to you on a voluntary basis as part o f our continuing discussions with EPA regarding fluorochemistry. This information includes studies on PFOS relating to the following areas: (i) pharmacokinetics; (ii) teratology; and (iii) epidemiology and medical surveillance. A listing o f the enclosed studies has been attached to this letter, and summaries also have been provided for each category o f studies. Please note that incorrectly applied legends relating to legal privileges and proprietary protections have been removed from certain documents. Finally, you should be receiving under separate cover additional studies on PFOS relating to reproductive toxicology that 3M will also be submitting to the TSCA Section 8(e) docket. 3M plans to provide you with additional information on PFOS and other fluorochemicals in the near future. In this regard, we have been trying to contact you to address scope and procedural matters, and we hope to talk with you the week o f April 24, 2000. Please do not hesitate to call me or Dr. Larry Zobel, 3M 's Medical Director, with any questions. I look forward to talking with you. Very truly yours, William A. Weppner, Ph D Director o f Environmental, Health, Safety, and Regulatory Affairs Specialty Materials Markets 3M Bldg 236-IB -10 3M Center St. Paul, MN 55144 rOc-=o> X --< PO CJ Opo ~---oCAromn c ~o q p n --V-' 7 > r<xo 000008 Corporate Health Physics Corporate Industrial Hygiene & Ergonomics Corporate Occupational Medicine Corporate Toxicology 3M Medical Department 3M Center, Building 220-2E-02 PO Box 33220 St. Paul, MN 55133-3220 651 733 1110 3M Attachments to April 21, 2000 letter to C. Auer from W. Weppner (Radiolabel Oral Absorption and Intravenous Pharmacokinetic Studies in Rats) 3M Technical 1. Synthesis and Characterization of FC-95-14C, November 2, 1979. 2. Extent and Route of Excretion and Tissue Distribution of Total Carbon-14 in Rats after a Single Intravenous Dose of FC-95-14C, December 28, 1979. 3. Absorption of FC-95-14C in Rats after a Single Oral Dose, October 26, 1976 4. J. D. Johnson, et. al., Cholestyramine-Enhanced Fecal Elimination of Carbon-14 in Rats after Administration of Ammonium [14C]Perfluorooctanoate or Potassium [14C]Perfluorooctanesulfonate, Fundamental and Applied Toxicology 4, pages 972976(1984). 000009 Medicine, Health Physics Industrial Hygiene, Toxicology 3M Medical Department 3M Center, Building 220-2E-02 PO Box 33220 St. Paul, MN 55133-3220 612 733 1110 3M Attachments to April 21, 2000 letter to C. Auer from W. Weppner (Dermal Absorption and Intravenous Pharmacokinetics in Rabbits) 3M Technical Reports 1. Single-Dose Intravenous Pharmacokinetic Study of T-6246 in Rabbits. 3M Environmental Laboratory Study # AMDT-042095.1 2. Single-Dose Dermal Absorption/Toxicity Study of T-6049 in Rabbits. 3M Environmental Laboratory Study # AMDT020895.1 3. Single-Dose Intravenous Pharmacokinetic Study of T-6049 in Rabbits. 3M Environmental Laboratory Study #AMDT-112294.1 o o o o io Corporate Health Physics Corporate Industrial Hygiene & Ergonomics Corporate Occupational Medicine Corporate Toxicology 3M Medical Department 3M Center, Building 220-2E-02 PO Box 33220 St. Paul, MN 55133-3220 651 733 1110 3M Attachments to April 21, 2000 letter to C. Auer from W. Weppner (Teratology Studies in Rats and Rabbits) 1. Rat Teratology Study T-3351 Final Report Dec 19, 1983, Hazelton Laboratories America Project #154-160. 2. December 7, 1983 Letter to Mr. William C. McCormick, III from E. Marshall Johnson, Ph.D., reviewing draft of above. 3. Oral Teratology Study of FC-95 in Rats, Riker Laboratory, Experiment # 068TR0008, December, 1980. 4. November 12, 1982, Letter to Franklin D. Griffith, Ph.D. from E. Marshall Johnson, Ph.D., reviewing the above. 5. Oral (Stomach Tube) Developmental Toxicity Study of PFOS in Rabbits, Study #418-012, January 11, 1999, Argus Laboratories. oooon Corporate Health Physics Corporate Occupational Medicine Corporate Product Responsibility Corporate Toxicology 3M Medical Department 3M Center, 220-2E-02 PO Box 33220 St. Paul, MN 55133-3220 651 733 1110 April 21, 2000 Attachments To April 21, 2000 Letter to C. Auer from W. Weppner (Medical Surveillance and Epidemiology) Final Reports 1. An Epidemiologic Investigation of Clinical Chemistries, Hematology and Hormones in Relation to Serum Levels of Perfluorooctanesulfonate in Male Fluorochemical Production Employees. [Included is a 3M report of medical surveillance data. Also included is a published paper from this 3M report.] 2. Fluorochemical Exposure (Serum) Assessment of (3M) Decatur Chemical and Film Plant Employees. [Included are a 3M study protocol and report ] 3. Mortality Study of Employees at 3M Plant in Decatur, Alabama [Included is a University of Minnesota final report.] 4. Determination of Serum Fluorochemical Levels in Sumitomo 3M Employees [Included are a 3M study protocol and final report.] 5. Analysis of Selected Decatur Employee Serum for Sulfonic and Carboxylic Fluorochemicals [Included is a 3M technical report ] 6. Fluorochemical Control Study [Included is a 3M report of medical surveillance data.] 7. Working Memorandum on Data Quality Assessment [Included is a Battelle Laboratory memorandum regarding the mean and range of perfluorooctanesulfonate sera sample data collected by 3M from current and historical human populations.) 000012 Attachments to April 21, 2000 letter to C. Auer from W. Weppner (Tissue Extraction and Analysis Methods) 1. 3M Environmental Laboratory Method. Extraction o f Potassium Perfluorooctanesulfonate or Other Fluorochemical Compounds from Serum for Analysis Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-4.1. Adoption Date: 03/01/99. 2. 3M Environmental Laboratory Method. Analysis o f Potassium Perfluorooctanesulfonate or Other Fluorochemicals in Serum Extracts Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-5.1. Adoption Date: 03/01/99. 3. 3M Environmental Laboratory Method. Extraction o f Potassium Perfluorooctanesulfonate or Other Fluorochemical Compounds from Liver for Analysis Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-6.0. Adoption Date: 07/22/99. 4. 3M Environmental Laboratory Method. Analysis o f Potassium Perfluorooctanesulfonate or Other Fluorochemicals in Liver Extracts Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-7.0. Adoption Date: 07/22/99. 5. 3M Environmental Laboratory Method. Extraction o f Potassium Perfluorooctanesulfonate or Other Fluorochemical Compounds from Urine for Analysis Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-96.0. Adoption Date: 07/28/99. 6. 3M Environmental Laboratory Method. Analysis o f Potassium Perfluorooctanesulfonate or Other Fluorochemicals in Urine Extracts Using HPLC-Electrospray/Mass Spectrometry. Method Number: ETS-8-97.0. Adoption Date: 07/28/99. 000013 Study Protocols/Proposals of Ongoing Research 1. Identification of Fluorochemicals in Sera of Children in the United States. [Included is a 3M study protocol. Study is on-going. Final report due January 1, 2001] 2. Serum fluorochemical trends of out-of-county residents in CLUE I (1974) and Clue II (1989) epidemiologic investigations. [Included is a Johns Hopkins University study protocol. Study is on-going. Joint 3M/Johns Hopkins University final report is due January 1, 2001.] 3. Identification of Fluorochemicals in Human Tissue. [Included is 3M study protocol. Suty is on-going. Final report is due January 1, 2001.] 4. An Epidemiologic Analysis of the Inpatient and Outpatient Claims Event and Episode Experience of 3M Decatur Employees, 1993-1998. [Included is a 3M study protocol. The study is on-going. Final report is due September 15, 2000.] 5. Determination of Serum Elimination Half-Lives of Ammonium Perfluorooctanoate, Perfluorooctane Sulfonic Acid, Perfluorohexane Sulfonic Acid and Total Organic Fluorine in Decatur Chemical Plant Retirees. [Included is a 3M study protocol. The study is on-going. Final report is due June 1, 2004. Interim draft reports will be issued ] 1 000014 Document Services CustOtP'-oJAntumeatmnaaement $ m>J U.-i f t o *M.D,U*H_SP m 55144 OCTlft HCI 22 L8S 90U Dot s i z fiDDRESS lmL m pflCKRE FR THIS SHIPMENT T0 dc 20460 1 ^ 8 0 7 7 8211 8191 ffedgjj. OaWB0?7 8211 $191 REF : P 10279722 220mr Bus! Di PRIORITY QUERNIGHT MON cad # 0085471 21APR00 Dlier by: . e u TRt# R 0 7 7 R711 P1P1 Q/QPD0IGI PRIORI TV OVERNIGHT MON enp* 171513 25APR08 - 8077 8211 8191 FORM B201 20460 -DC' US 9 WASA 153078-077 BIT 06/99 M gna C o p ie: Fax El Dhtributio faxequipm Copier & Supply* Technica Mr. Charles Auer 5 Director Chemical Control DivisiopN Room 7405 U.S. EPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, N.W. Washington, DC 20460 1 h L? Corporate Health Physics Corporate Industrial Hygiene & Ergonomics Corporate Occupational Medicine Corporate Toxicology 3M Medical Department 3M Center, Building 220-2E-02 PO Box 33220 St. Paul, MN 55133-3220 651 733 1110 3M Attachments to April 21,2000 letter to C. Auer from W. Weppner (Radiolabel Oral Absorption and Intravenous Pharmacokinetic Studies in Rats) 3M Technical 1. Synthesis and Characterization of FC-95-14C, November 2, 1979. 2. Extent and Route of Excretion and Tissue Distribution of Total Carbon-14 in Rats after a Single Intravenous Dose of FC-95-14C, December 28, 1979. 3. Absorption of FC-95-14C in Rats after a Single Oral Dose, October 26,1976 4. J. D. Johnson, et. al., Cholestyramine-Enhanced Fecal Elimination of Carbon-14 in Rats after Administration of Ammonium [14C]Perfluorooctanoate or Potassium [14C]Perfluorooctanesulfonate, Fundamental and Applied Toxicology 4, pages 972976 (1984). 000016