Document V3e4KyDXoL3zjv9QL0bg32wON

Krtfcsrtw E. Rwd, PM*. StaffVice PrcrideM 900 Buril Avenue BuHdng 42-2E-26 PO Box 33331 S leali, VW 55133-3331 1 7784331 CERTIFIED MAIL February 1,2002 Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e) Office o f Pollution Prevention and Toxics US EPA 1200 Pennsylvania Ave., NW Washington, DC 20460-0001 Re: TSCA 8(e) SUPPLEMENTAL NOTICE ON: Perfluorooctanesulfonate Docket Noe. 8EHO-118Q-374 Dear Sir. 3M has received draft reports o f reproduction studies o f northern bobwhite and mallard and Perfluorooctanesulfonate (PFOS) from W ildlife International, LTD., indicating effects as described below. The studies were done according to FIFRA Guideline 71-4 and OECD Guideline 206 and followed a pilot range-finding study Out was deemed inconclusive as to treatment-related reproductive effects. The studies were based on 21week feedings containing PFOS. Draft histopsthology results are available at this time, but analytical results o f serum and liver levels will not be obtained for at least two months. Therefore, it is not yet possible to correlate the findings described herein with present levels o f PFOS in wildlife. I. Mallard Dietary Study Results: 16 pairs o f ducks were exposed via feed for 21 weeks; hatchlings were reared without exposure for 2 weeks. The 50ppm feed level group was terminated at week 7 due to overt signs o f toxicity. The ISOppm feed level group was dropped to 20ppm at week 3, but terminated at week 5 due to overt signs o f toxicity. The lOppm feed level group showed no difference in reproductive performance from foe control, no treatment-related mortalities (adult and young), no overt signs o f toxicity, no body weight o r liver weight differences from foe control, no difference in degeneration/atrophy o f seminiferous tubules from foe control, no difference in eggshell thickness from foe control, no feed consumption differences from foe control and no offspring differences from foe control offspring. However, reduced testes size was noted in 2 control males and 7 treated males. Histopsthology showed 1 control and 4 treated males had decreased spermatogenesis. The pathology report noted that foe reduced testicular size, with or without microscopic evidence o f decreased spermatogenesis, is a feature most consistent with early post- Office o f Pollution Prevention and Toxics Page No. 2 February 1,2002 reproductive phase regressions, a normal physiological phenomenon. The degeneration/atrophy noted in the control and treated adult birds may simply represent a later stage o f this normal change. However, the increased incidence o f reduced size suggests that treatment may have accelerated the normal post-reproductive phase regression. I I Northern Bobwhite Quail 16 pairs o f northern bobwhite quail were exposed for 21 weeks; hatchlings were reared without exposure for 2 weeks. The SOppm feed level group was terminated at week 7 due to overt signs o f toxicity. The ISOppm feed level group was dropped to 20ppm at week 3 and terminated after week 4 due to overt signs o f toxicity. The lOppm feed level group showed no adult treatment-related mortality, no body weight differences from control, no feed consumption differences from control, no differences in eggshell thickness from the control, and no differences in spermatogenesis or morphology o f testes from control. However, there were treatment-related effects: - reduced reaction to stimuli, ruffled appearance and lethargy (adults) - female liver weights were higher than controls (adults) - offspring survival rate was affected (fewer number o f 14-day survivors per eggs set) - necropsy indicated reduced testes size in 1 control male and 7 treated males (adults) No other reproductive end points were affected. The pathology report noted that the reduced testicular size, with or without microscopic evidence o f decreased spermatogenesis, is a feature most consistent with early postreproductive phase regressions, a normal physiological phenomenon. The degeneration/atrophy noted in the control and treated adult birds may simply represent a later stage o f this normal change. However, the increased incidence o f reduced size suggests that treatment may have accelerated the normal post-reproductive phase regression. The final GLP studies and the data from the pilot study will be submitted to EPA, along with the analytical reports on sera and liver concentrations o f PFOS as soon as they are available. For further information, please contact me at 651-778-4331. Sincerely, Katnerine E. Reed Staff Vice President, Environmental Technology and Safety Services