Document zQRN9dX8XY0gOOy4On7xe5B1g
3M Specialty Materials
3M Center
St. Paul, MN 55144-1000 651 733 1110
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December 16, 2002
VIA FEDERAL EXPRESS
Dr. Charles Auer US Environmental Protection Agency EPA East, Room 3166 1201 Constitution Avenue, NW
Washington, DC 20460
Dr. Oscar Hernandez US Environmental Protection Agency EPA East, Room 6220A 1201 Constitution Avenue, NW Washington, DC 20460
Re: Information on Perfluorooctane Sulfonates and Related Compounds
Dear Charlie and Oscar:
Attached herewith is a copy of a recent submittal to the Docket No. AR-226 and the FYI Docket of a biodegradation study and analytical reports pertaining to perfluorooctanoic acid and its homologues. The reports are part of the continuing 3M voluntary submissions of data on perfluorooctane sulfonates and related compounds and our ongoing dialogue with EPA regarding fluorochemicals.
Included in this submission are the following:
"Biodegradation Study Report: Biodegradation Screen Study for Telomer Type Alcohol", Pace Analytical Services, Inc. Study Number CA085, 3M Sponsor Study Number E01-0684.
"Comparative Analysis of Fluorochemicals in Human Serum Samples Collected by 3M and Obtained Commercially", 3M Environmental Laboratory Study Number E02-1053.
"Analysis of Endogenous Fluorochemicals in Normal Pooled Human Serum and Plasma", 3M Environmental Laboratory Study Number E02-1039.
Page 2 Dr. Charles Auer Dr. Oscar Hernandez
"Analysis of Pooled Human Sera and Plasma and Monkey Sera for Fluorocarbons Using Exygen Method ExM-023-071", Exygen Research Study Number 023-082, 3M Sponsor Study.
The analytical reports provide information of the isomer distribution of perfluorooctanoate. This information submittal responds to an ongoing question related to the widespread presence of PFOA in human sera samples. The analytical method used for the respective analytical studies has been fully validated for PFOS in rat liver and plasma matrices down to 50 ppb. Limited cross validation for PFOS, PFOA and the other perfluorinated carboxylates in human sera and plasma down to 0.1 ppb was performed. Additional validation is recommended.
3M would appreciate the opportunity to meet with you at your convenience to discuss the content of these reports. In the meantime, if you have any questions, please contact me at 651/733-6374.
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Michael A/Santoro Director of Environmental, Health Safety and Regulatory Affairs Specialty Materials Markets 3M Center, Building 236-1B-10 St. Paul, MN 55144 651-733-6374 (phone) 651-733-1958 (fax) E-mail: masantoro@mmm.com
3M Specialty Materials
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3M Center St. Paul, MN 55144-1000 651 733 1110
'W
December 16, 2002
VIA FEDERAL EXPRESS
Document Control Office (DCO) Office of Pollution Prevention and Toxics (OPPT) US Environmental Protection Agency EPA East, Room 6428 1201 Constitution Avenue, NW Washington, DC 20460
Attention: Docket No. AR-226 and the FYI Docket
Dear Sir or Madam:
This continues 3M's voluntary submissions of data on perfluorooctane sulfonates and related compounds, as part of our ongoing dialogue with EPA regarding fluorochemicals.
Included in this submission are the following:
"Biodegradation Study Report: Biodegradation Screen Study for Telomer Type Alcohol", Pace Analytical Services, Inc. Study Number CA085, 3M Sponsor Study Number E01-0684.
"Comparative Analysis of Fluorochemicals in Human Serum Samples Collected by 3M and Obtained Commercially", 3M Environmental Laboratory Study Number E02-1053.
"Analysis of Endogenous Fluorochemicals in Normal Pooled Human Serum and Plasma", . 3M Environmental Laboratory Study Number E02-1039.
"Analysis of Pooled Human Sera arid Plasma and Monkey Sera for Fluorocarbons Using Exygen Method ExM-023-071", Exygen Research Study Number 023-082, 3M Sponsor Study.
Page 2 Document Control Office (DCO)
The analytical method used for the respective analytical studies has been fully validated for PFOS in rat liver and plasma matrices down to 50 ppb. Limited cross validation for PFOS, PFOA and the other perfluorinated carboxylates in human sera and plasma down to 0.1 ppb was performed. Additional validation is recommended.
We will continue to provide information as it becomes available. Please feel free to contact me if you have any questions.
Very truly yours,
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Cc: Dr. Charles Auer Dr. Oscar Hernandez
Michael A. Santoro Director of Environmental, Health Safety and Regulatory Affairs Specialty Materials Markets 3M Center, Building 236-IB-10 St. Paul, MN 55144 651-733-6374 (phone) 651-733-1958 (fax) E-mail: masantoro@minm.com