Document LgRwY35w4aD9xmmOprkZX2jmd

0PmMHatkal Ukarrtarv 1 BUS(B^hiBSSStSBUiB^iB RUbAob4 * O.Bm M Nbwb* D1I 71M W DuPont Haskell Laboratory G tn id L Ktnktdy Director, Applied Toxicology DuPont Haskell Laboratory P.O. Box SO EUctonRoad Newark. Delaware 19714-0050 ' Phone: (302) 366-5239 ~ 4 & 2 2 t> -/ S 5 $ * * * .4i Document Control Office (7407) Room G99 East Tower ATTN: FYI Office of Pollution Prevention and Toxics CJ.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460-0001 Dear Sir/Madanx ** b'YT-Difll-001378 March 8.2001 This letter is in reply to Richard H. HeflerN letter dated February 14, 2001 to me concerning the above-referenced FYI submission. The information provided in the January 2 5 ,2<XH and June 23,2000 submissions was provided voluntarily fo UPA in response to a request from Mr. Charles Auer for exposure and use information from DuPont pertaining to ibe substance in issue. The blood serum test results reflect exposure data. No adverse health effeets associated with this substance have been found among exposed employees. It is further noted that studies submitted by the 3M Company, which is the manufacturer of the substance, also conclude that no health effects associated with this substance have been found amongst its exposed employees (see JM .XEHQ-0200-1459ft. dated January 2 8 .2(XXJ). Those studies, eillicr themselves or through reference to other studies published in the open scientific literature, report that this substance is mown ui he found in human blood serum o f employees exposed to the substance'. 1See (1) Oilliluad 1*0. Mitmlot IS. Mortality Aiming Empluyw* of i PeffluarooctiiOoit: Add Pmducuu Plant. J. Cvxup. Mud. 1WVJJrMO 951; ibj Gilliland PD. Mnadci IS. Swum PalluurooetaaoiK Acid dad GK003126 SSZ'ON 0/20: 0 0-60 10/S0/70 9297 LS7 20C & 000036 AVI TI3NSVM INOdfM GK003126 n rw u i-o iT n i HMarch 2N1 h |i2 t* Per E P A 'i June 19 9 1TSCA Section 8(e) Reporting Guide, it is provided that "In deciding whether information is 'substantial risk* information, one most consider I) the seriousness of the advene effect, and 2) the Tact nr probability of the effect's Occurrence." As stated above, no adverse health effects associated with ibis substance have been found among exposed employees. In the absence of on advene effect, the information was deemed to not meet EPA TSCA Section 8(e) reporting criteria. In addition, per the 1991 TSCA Section 8(c) Reporting Guide, information need not he submitted if it is published in the open scientific literature. As referenced above, prior published studies have reported that this substance is present in the blood serum o f workers exposed to the substance. Also, in 1980, it was reported in the American Industrial Hygiene Association Journal that periluorooctanoaic anion was found in the blood of workers exposed to ammonium perfhiorooctanoate1. The blond scram infbmiution provided in the DuPont submissions is not indicative of information not known to the Agency. It is consistent with information already published in the open scientific literature and as such, was deemed to not meet the criteria for TSCA section 8(e) reporting. Please contact me directly if you need further clarification ur wish to discuss this matter in more detail. Very truly yours, Gerald Kennedy GK003127 Hcpotic Enzym**, Lipoproteins. and Choiestcml: A Study nf Occupeliunally Rxpoeed Men. Am. J. fad. Med. IWfe29-3W-56I; (c) Olren GW. Glllilsnd HD, Burlcw MM, Iturru JM. Mandel JS. Mandel TH. An Epidemiologie Investigation of Reproduetive Hormone* in Men wiih Oeeopedanu! Uxpomre tu Pcriluoruoctanmc Aeid. i. Ocvup. Bnv. Med. I99*;40:614-622. 1 U M P A Soren** SD, RoaeH, DE. Health Summ >fPteni Werken Expaeed to Fhmrochemicaie - a Preliiumaor Report. American Industrial Hygiene AwweiMian Journal. 1960,4184-5SV. S&:ON 0 / 0 : 0 SO:60 L0/C0/90 8289 IS9 2 0 & B n TI35ISVH INOdfid 000037 6K003127