Document yQzL3MKoy0xKjEEzzd9oYX1X

& f 6? - O q 0 4 - - September 17, 2004 By Certified Mail Document Processing Center [7407M] Attention TSCA 8(e) Coordinator Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 CO M PANY SANITIZED - DO ES NO T CO NTAIN CO NFIDENTIAL BUSINESS INFO RM ATIO N il in imi unii il in 8 E HQ - 15 6 6 6 8804000023 Re: Information Submission Under TSCA Section 8(e) Dear Sir or Madam: Pursuant to Section 8(e) of the Toxic Substances Control Act ("TSCA"), [CBI Deleted] is submitting information pertaining to the following three substances: 1. perfluorooctanoic acid ("PFOA"), CAS No. 335-67-1 2. perfluorononanoic acid ("PFNA"), CAS No. 375-95-1; and 3. perfluorodecanoic acid ("PFDA"), CAS No. 335-76-2. The information we are providing, which is attached to this letter, consists of worker monitoring data that were recently obtained and tabulated by [CBI Deleted] . These data reflect measured levels of the subject chemicals in blood samples taken from workers at the [CBI Deleted] facility located at [CBI Deleted] . Blood levels were monitored in a total of 281 individuals working on three production lines: a production line for [CBI Deleted] , in which [CBI Deleted] was used as a processing aid; a production line for [CBI Deleted] , and a production line for [CBI Deleted] . In addition, a small number of workers in [CBI Deleted] research and development and quality assurance divisions were also included among the 281 individuals sampled. [CBI Deleted] believes that the attached information does not rise to the level of "substantial risk" information that must be submitted under TSCA Section 8(e), for the following reasons.-o rv) First, [CBI Deleted] believes that the worker monitoring data on PFOA that were obtained by [CBI Deleted] are merely corroborative of information that is already well known to EPA. We are aware that extensive information has previously been submitted to the Agency under TSCA Section 8(e) and other provisions of TSCA pertaining to co blood levels of PFOA in workers at U.S. facilities that produce and/or utilize [CBI Deleted]. O' f- ^ T I O s Document Processing Center [7407M] Attention TSCA 8(e) Coordinator September 17, 2004 Page 2 Second, [CBI Deleted] believes that worker monitoring data gathered from the [CBI Deleted] are irrelevant to assessing potential exposures and risks in the United States, because [CBI Deleted] employs a unique process for using [CBI Deleted] , that is not utilized in any facility in the United States. To the extent that differences in blood levels are observed between workers in the United States and workers at [CBI Deleted], those differences are likely attributable to the unique manufacturing process employed by [CBI Deleted] . Third, to the best of our knowledge, there are no facilities in the United States that manufacture [CBI Deleted] . Consequently, blood monitoring data from the [CBI Deleted] are irrelevant to assessing risks and/or exposures to workers in the United States. Thus, the worker monitoring data obtained by [CBI Deleted] are either (i) corroborative of information that is already well known to EPA and has previously been submitted to the Agency under TSCA Section 8(e) and other provisions or (ii) irrelevant to assessing risks in the United States. As a consequence, the data do not constitute "substantial risk" information that must be reported under TSCA Section 8(e). Nevertheless, [CBI Deleted] is submitting this information under Section 8(e) to bring these data to the Agency's attention, consistent with our company's commitment to product stewardship, and out of an abundance of caution. If you have any questions regarding this submission, please contact me at [CBI Deleted] Also, please note that this submission contains confidential business information ("CBI") that should be protected against public disclosure. A "sanitized" version of this submission, from which CBI has been deleted is also being submitted herewith. Sincerely, [CBI Deleted] Attachment COMPANY SANITIZED DOES NOT CONTAIN CONFIDENTIAL BUSINESS INFORMATION Worker Monitoring Results for PFOA at the [CBI Deleted] PFOA 250 218 200 150 Number of Workers 100 50 19 6 3 3 2 13 7 4 2 1 2 0 n I;.1.l u l l |B B S !-- [ 1 ^ 1 -1 [ , m m m j I i r i m ,|i ,, IT tT I , ,, |m , -- mm. 0 - 0 . 5 1 .0 -2 .0 3 .0 -4 .0 5 .0 - 10.0 1 5 - 2 0 3 0 - 4 0 Blood Concentration of PFOA (ppm) 01 5 0 -6 0 70 60 Blood Concentration of PFOA (ppm) 50 ^ 30 20 10 0 PFOA 2 .1 Average o Minimum 60. 5 j ........... Maximum COMPANY SANITIZED DOES NOT CONTAIN CONFIDENTIAL BUSINESS INFORMATION Worker Monitoring Results for PFNA at the [CBI Deleted] PFNA Number of Workers PFNA Blood Concentration of PFNA (ppm) Average Minimum Maximum COMPANY SANITIZED DOES NOT CONTAIN CONFIDENTIAL BUSINESS INFORMATION Worker Monitoring Results for PFDA at the [CBI Deleted] 250 200 150 Number of Workers 100 50 0 PFDA 0 0 ~ 0.05 0.05 ~ 0.1 Blood Concentration of PFDA (ppm) 0.07 0.06 0.05 Blood 0.04 0.03Concentration of PFDA(ppm) 0.02 0.01 0 PFDA Average Minimum Maximum