Document 7Mv6pBBYRrxmeMORe2gJ19BwB

NORTHERN KENTUCKY OFFICE SUITE *40 1*1' OlXiE HIGHWAY COVINGTON KENTUCKY4ian-A7C4 506-331-2036 513-361-2638 FAX 513-381-6613 Ro b e r t a . Bilott (513) 357-9638 iiott@taftlaw.com TAFT, STETT1NIUS & HOLLISTER LLP 425 WALNUT STREET, SUITE 1800 CINCINNATI, OHIO 4520 2 -3 9 5 7 513-381-2838 FAX 513-381-0205 www taftlaw com A R S .J 1 6 October 25, 2002 TELECOPY AiND REGULAR U.S. MAIL Perry D. McDaniel. Esq. West Virginia Department o f Environmental Protection Office o f Legal Services 1356 Hansford Street Charleston, WV 25301 CLEVELANO OHIO OFFICE 3500 BP TOWER 200 PUBLIC SQUARE CLEVELAND OHIO i-4 .;3 0 2 2'S-24i-2aSB FAX 2-S-24-.3707 COLUMBUS OHIO OFFICE 21 EAST STATE STREET COLUMBUS OHIO 432*5-422' 514-22' -2S38 FAX 614-22' -2007 _ r*o CtAZ>> O~V' r- ; -o o cn (33 C3 en Re: Response To WVDEP's September 13. 2002. Letter Regarding CAT Team Activities Involving C-8_______________________________________ _ Dear Perry: This letter responds to the letter from your office dated September 13. 2002. As you are aware, we did not receive a copy o f that letter until October 10. 2002 - the day we reviewed files made available to us at WVDEP's offices and noticed copies o f the letter in those files. Based on our review o f WVDEP's files on October 10, 2002. which included several earlier drafts o f the September 13. 2002. letter in the files o f Dr. Dee .Ann Staats. we understand that Dr. Staats drafted the letter for your signature to respond to questions raised in our letter dated August 19. 2002. As explained below, WVDEP's response confirms that WVDEP inexplicably deviated from the express requirements o f the Consent Order entered between the State and E.I. duPont de Nemours and Company (the "Consent Order") that set up the process that the C-8 Assessment of Toxicity Team ("CAT Team") was supposed to follow in its assessment o f C-8 toxicity issues. The Consent Order clearly and expressly provided tor the CAT Team to perform its activities in three basic "Phases" as set forth on Pages C-4-C-9 o f the Consent Order. Phase I involved public meetings to discuss the CAT Team process. During Phase II. WVDEP's consultant. TERA. was to assume primary responsibility for each o f the following tasks: 1. Review o f the toxicological information regarding C-8 provided by WVDEP and development o f a proposal for selecting provisional reference doses, screening levels, and a risk assessment for C-8: liT * i 'R ; Perry D. McDaniel, Esq. October 25. 2002 Page 2 2. Consultation with the other toxicologists on the CAT Team, as coordinated by Dr. Staats. regarding TERA's proposed approach for developing provisional reference doses, screening levels, and risk assessment activities for C-8; 3. Development o f provisional reference doses for C-8 for the oral, inhalation, and dermai (if possible) routes o f exposure: 4. Calculation o f screening levels for C-8 in water, soil, and air based on the risk factors estimated by TERA; 5. Performance o f one general risk assessment involving comparison o f exposure concentrations to screening levels (using data obtained from other ongoing C-8 efforts such as WVDEP's and DuPont's air modeling) for the Letart Landfill. Dry Run Landfill. Local Landfill, Washington Works Plant, and Lubeck Public Service District water supply, that focuses on current risk to human health, including workers and residents, with such risk assessment to include: A. Identification o f reasonably anticipated land use, surface water and groundwater use; B. Identification o f receptors; C. Identification o f exposure pathways: D. Identification o f exposure concentrations; and E. Comparison o f exposure concentrations to appropriate screening levels. 6. Review o f available information to determine whether sufficient studies have been performed and data have been collected to develop C-8 screening criteria for protection o f ecological health, particularly aquatic health: and 7. Preparation o f a draft and final document that discusses the results o f TERA's efforts and summarizes the data utilized from other C-8 efforts. (Consent Order, at C-4 through C-5.) Under the Consent Order. Phase III o f the CAT Team's work is to involve a "second public meeting" designed to "present to the citizenry the results of the efforts o f the GIST and CAT Teams including C-8 concentrations in groundwates residential wells and public wells the screening levels and the general risk assessment. Air (M m Perry D. McDaniel, Esq. October 25, 2002 Page 3 modeling results o f the efforts o f WVDEP and DuPont will be discussed also. The WVDEP will address any further actions that may be necessary." {Id. at C-5.) It is now clear from the Final CAT Team Report and the September 13, 2002. letter from your office that tasks to be accomplished by TERA as part o f the "Phase II" activities o f the CAT Team were not performed by TERA. as required under the Consent Order. More specifically. WVDEP confirmed in the September 13, 2002. letter that TERA did not perform the general risk assessment it was supposed to perform under the Consent Order, and that the one page "Comparison o f Screening Levels to Site-Related Data" that now appears as Section 3 o f the Final CAT Team Report was, in fact, drafted by WVDEP and not by any representatives o f TERA. In fact, it has now been confirmed that "TERA did not have the information necessary' to draft" the information set out in Section 3 o f the Report. (WVDEP's September 13, 2002, letter at 1.) No explanation has been provided as to why TERA was not provided the information necessary to complete the actual risk assessment activity it was supposed to perform as part o f the Phase II CAT Team work, or why WVDEP unilaterally took over the task o f completing that entire Section o f the Final CAT Team Report. In addition, no explanation has been provided as to why the risk assessment information prepared solely by WVDEP inexplicably omits the information required under the Consent Order relating to: identification o f reasonably anticipated land use, surface water, and groundwater use; identification o f receptors; identification o f exposure pathways; identification o f all exposure concentrations: and actual exposure concentrations at the three DuPont landfills specified in the Consent Order. WVDEP's one page "risk assessment" also says nothing about the cumulative risk posed to those living in the communities surrounding DuPont's Washington Works facility who are being exposed to C-8 in both air and water, and possibly soils. It is not clear whether WVDEP now even intends to collect any soil data. In addition, despite the express requirements o f the Consent Order that TERA should have been provided data obtained from the ongoing DuPont and WVDEP air modeling o f C-8 emissions, {see Consent Order, at C-5), WVDEP's September 13. 2002. letter confirms that WVDEP did not share that information with the other members o f the CAT Team, including TERA. {See WVDEP September 13. 2002, letter, at 3 (WVDEP confirms that, although Dr. Staats and WVDEP were aware o f the level o f DuPont's C-8 air emissions, "the other members o f the [CAT Team] toxicology panel were not provided with information on the air modeling.").) The lack o f any involvement by TERA or any o f the other members o f the CAT Team in any o f the actual risk assessment activities required under the Consent Order beyond selection of screening levels is further confirmed by the lack o f any reference to those additional risk assessment activities or evaluations in any o f the meeting notes from the CAT Team members or in the final CAT Team Report itself, except for the one page "Comparison o f Screening Levels to Site Related Data" that we now understand was prepared solely by WVDEP. It is noted that the N llH Perry D. McDaniel, Esq. October 25, 2002 Page 4 "final" CAT Team Report also inexplicably omits any information with respect to the development o f screening criteria for protection o f ecological health, as expressly required under the Consent Order, other than a reference at the beginning o f the CAT Team Report that such information may be forthcoming in "an addendum to [the final CAT Team] Report. . . to be released in fall 2002." It is not clear why WVDEP chose to ignore the express requirements of the Consent Order to include the results o f all o f the risk assessment activities required under the Consent Order, along with the screening criteria for protection o f ecological health, in one final CAT Team Report before the report was released to the public. It is also unclear as to why WVDEP apparently chose not to complete "Phase III" o f the CAT Team work, which requires a second public meeting to present to the citizenry the results o f the "general risk assessment" activities required under the Consent Order, and "air modeling results o f the efforts o f WVDEP and DuPont." (See Consent Order, at C-5.) O f particular concern to our clients is WVDEP's failure to explain why. WVDEP has said nothing publically with respect to whether DuPont is exceeding the screening levels selected by the CAT Team for C-8 in air. Although WVDEP wasted no time releasing to the public assurances that DuPont was not exceeding the CAT Team's screening level for C-8 in water within only a matter o f davs after the CAT Team selected that screening level, it has now been several months since the CAT Team selected its screening levels for C-8 in air but there has been no comment from WVDEP with respect to whether WVDEP's and DuPont's air emissions data indicate that DuPont has exceeded the appropriate air levels in either West Virginia or Ohio. The lack o f comment from WVDEP on this issue is puzzling, given that the Year 2000 air modeling data contained within WVDEP's own public files confirms and has confirmed for several months that those air emissions exceed the lower end o f the CAT Team's air screening level range (from 0.3 ug/m3 to 10 ug/m3) for C-8 in the local community, and indisputably exceed the "median value" air screening level o f 1 ug/m3 at the Washington Works property line. Although the Consent Order expressly provides WVDEP the authority to promptly issue a notice to DuPont that "DuPont's operations have resulted in C-8 exposures above the screening levels," which would trigger DuPont's obligation to prepare a plan to reduce its C-8 air emissions, we are unaware o f WVDEP having taken any steps to send such a notice to DuPont. Instead, we understand that, rather than relying upon the year 2000 air modeling data generated by DuPont and WVDEP to determine DuPont's compliance with the C-8 air screening levels, the generation o f which was required under the terms o f the Consent Order, WVDEP apparently is now providing DuPont the opportunity to try to generate new. different air emissions data. This point was confirmed on page 46 o f the final CAT Team Report where WVDEP notes that "the air modeling effort continues and is currently focusing on determining the results o f air emissions reduction efforts by DuPont required in the Consent Order . . . by the end o f 2003." (Final CAT Team Report, at 46.) mM h Perry D. McDaniel, Esq. October 25, 2002 Page 5 Consequently, we understand that, rather than making a determination as to whether DuPont is exceeding the CAT Team's screening level for C-8 in air using the Year 2000 modeling data required under the Consent Order that would confirm such exceedances. WVDEP is holding o ff making any such determination until after DuPont has been given a chance to try to generate new, and different air emissions data. WVDEP should explain promptly whether DuPont has exceeded the air screening range for C-8 established by the CAT Team in either West Virginia or Ohio using the Year 2000 modeling data already generated and possessed by both DuPont and WVDEP, or at least explain how long DuPont will be given to try to generate new, different data and why. The comment in your September 13, 2002 letter that DEP has not received on behalf of our clients "any substantive comments about the process used by the agency in the evaluation of the scientific studies" by the CAT Team is disingenuous, at best. Numerous letters have been submitted to WVDEP setting out specific objections to and concerns with the methodology and results o f the CAT Team process. In particular, we forwarded to your agency, along with each of the members o f the CAT Team, including Dr. Staats, a letter dated June 10, 2002, providing very detailed substantive comments relating to our clients' concerns with respect to the process used by WVDEP and the CAT Team in evaluating C-8, and the CAT Team's evaluation o f the scientific studies relating to C-8. That letter identified numerous problems inherent in the methodology used by CAT Team and the CAT Team's results. As pointed out in that letter, these problems resulted in the generation o f C-8 screening levels over 150 times higher than the levels that should have been selected after reviewing the relevant studies according to the appropriate agency guidance and methodology. This point is confirmed by WVDEP's own C-8 screening level calculations from the summer o f 2001. which were based on an evaluation o f all o f the exact same studies reviewed by the CAT Team, with the exception o f a later two- generation rat reproduction study that was not finalized until the Spring o f 2002.. (See Attachment A (copy o f WVDEP's C-8 screening level calculations from the summer o f 2001. which were retrieved from the computer files that had been deleted by Dr. Staats).) As confirmed in the "Revised Draft Hazard Assessment o f PFOA and Its Salts" released to the public on October 17, 2002, by the United States Environmental Protection Agency ("USEPA s C-8 Report"), that later two-generation rat reproduction study confirmed the existence o f certain adverse effects that require an even more conservative approach to protecting public health - not less conservative. (See USEPA's C-8 Report, at 5-6, 64-73.) Now that the Final CAT Team Report has been released, we note that WVDEP has failed to explain the extent to which its screening level calculations are based on exposures in adults versus children. As confirmed in one o f the earlier draft screening level charts sent by TERA only to Dr. Staats, the screening level numbers can vary dramatically depending on whether the exposure group is assumed to be adults or children. (See Attachment B (also a document retrieved from computer files that had been deleted by Dr. Staats).) Screening levels for children 000180 Peny D. McDaniel, Esq. October 25. 2002 Page 6 would be less than half the screening levels derived for adults, according to TERA's calculations. (See id) Although we presume, for example, that the 150 ppb water screening level is based on adult exposures, there is no explanation as to how the lower screening levels for children have been handled in selecting the final screening levels set forth in the CAT Team Report. WVDEP's September 13. 2002. letter also now confirms that WVDEP derived its screening levels for C-8 through a process that was designed to identify those screening levels that could be agreed to by a "majority" o f a committee that included DuPont. Thus, rather than follow standard agency procedures for selecting the screening levels that are the most protective o f human health justifiable under the existing toxicological data, the CAT Team's screening levels represent only those levels that could be agreed to through a majority voting process for a group that included DuPont. The practical effect o f such a process is highlighted in WVDEP's description o f the manner in which the screening level for C-8 in air was selected. Although it is undisputed that members o f the CAT Team believed that a screening level for C-8 in air o f 0.3 ug/m3 was justifiable under the existing toxicological data for C-8, WVDEP has confirmed that that particular screening level was not selected, because some o f the other members o f the CAT Team preferred to rely on toxicological data that could support an air screening level for C-8 as high as 10 ug/m3. Yet, rather than select the more conservative C-8 screening level for air o f 0.3 mg/m3 in order to be the most protective o f public heath, the CAT Team selected a "median" value o f 1 ug/m3 as its final screening level for C-8 in air as a compromise. There is, therefore, no doubt that the CAT Team did not select the most conservative screening level for C-8 in air that was supportable by the available toxicological data. Our clients look forward to prompt confirmation from WVDEP as to when a CAT Team report will be released containing the results o f all o f the ecological screening levels and risk assessment activities that are required under the Consent Order. Once all o f that information is finalized and available, we would like to proceed with completing the deposition o f Dr. Staats. We also look forward to prompt confirmation from WVDEP as to what actions will be taken by WVDEP to immediately enforce DuPont's obligations under the Consent Order to ensure that its C-8 emissions do not exceed applicable C-8 screening levels in the surrounding West Virginia and Ohio communities. Thank you. Very truly yours. / RAB/mdm Attachments Roberf A , m ax Perry D. McDaniel, Esq. October 25, 2002 Page 7 cc: R. Edison Hill. Esq. (w/ attachments) Larry A. Winter. Esq. (w/ attachments) Heather Heiskell Jones, Esq. (w/ attachments) John R. McGhee, Jr., Esq. (w/ attachments) Richard A. Hayhurst, Esq. (w/ attachments) Greg Smith, Esq. (Ohio EPA. Legal) (w/ attachments) Janusz Z. Byczkowski, Ph.D. (Ohio EPA) (w/ attachments) Janet Sharke. Esq. (USEPA. Region 3) (w/ attachments) Lillian Pinzon. Esq. (USEPA. Region 5) (w/ attachments) OM HI DRAFT: DEVELOPMENT OF PROVISIONAL ORAL AND INHALATION REFERENCE DOSES AND PRELIMINARY SCREENING LEVELS FOR AMMONIUM PERFLUOROOCTANOATE A Provisional Oral Reference Dose (PRfDo) o f 3 x 10-5E or 0.00003 m gk gd av tor .Ammonium Perfluorooctanoate (C8) and a Provisional Inhalation Reference Concentration IPRfCi) o f 0.02 |ig/m 3 have been developed by WVDEP. Subsequently, a Preliminary Screening Level (PSLw) for groundwater o f l ppb was calculated based on this PRfDo and on the model for the water ingestion exposure pathway with default parameters commonly used by USEPA and WVDEP. The PRfCi o f 0.02 pg/m3 would serve as the Preliminary Screening Level (PSLi) for air. The scientific rationale used to develop the PRfCi and the PRfDo, and to calculate the PSLw is described below. Development of the Provisional Oral Reference Dose: .Ammonium perfluorooctanoate (C8 or APFO) is a potent synthetic surfactant. In biologic media, the ammonium quickly dissociates. C8, as perfluorooctanoic acid (PFOA), comprises 93 - 98% o f FC-143 FLUORAD Brand Fluorochemical Surfactant. Toxicity studies have been conducted on APFO, PFOA, and FC-143. The USEPA has conducted a literature search and review o f toxicological data regarding PFOA; their findings are summarized in the Draft Hazard Assessment o f PFOA (in preparation). This document, including supporting references, and information provided to WVDEP by DuPont, and the data contained on 7 compact discs as part o f the TSCA submittal by 3M were the major sources o f toxicological information utilized in the development o f the reference doses. The first step in the development o f a reference dose is to identify appropriate exposure studies. Chronic studies utilizing the appropriate route o f exposure and animal model are most highly desirable. However if such studies are not available, then subchronic studies utilizing other routes o f exposure may be employed for reference dose development by including additional uncertainty factors. Ideally a NOAEL. No Observable Adverse Effect Level, was determined in the study; however, if a NOAEL was not determined, then a LOAEL, Lowest Observable Adverse Effect Level, may be employed in reference dose development by including an additional uncertaintly factor. The only chronic oral exposure study available was conducted in male and female rats fed FC-143 over a two-year period (3M. 1987). A LOAEL o f 300 ppm ( l 4.2 mg'kg/day for male, and 16.1 mg/kg/day female) was determined in rats based on decreased body weight gains; increased liver and kidney weight; and toxicity in the hematological and hepatic systems. However, a LOAEL for female rates o f 30 ppm (1.6 mg'kg/day) was determined based on incidence o f ataxia and reversible ovarian tubular hyperplasia. To date, four 90-day subchronic oral exposure animal studies have been conducted - two in monkeys and two in rats. A LOAEL o f 30 ppm ( l .72 mg(kg/day) was determined by Goldenthal (1978a) in male rats exposed to a diet including FC-143 based im h WVDEP ! rs on increased liver weight; increased blood glucose; and decreased red cell counts. Palazzolo 1 1993) found a NOAEL o f 30 ppm (1.44 mg/kg/day) and a LOAEL o f 100 ppm (4.97 mg'kd/day) based on decreased body weight and body weight gain, and on increased absolute and relative liver weights with hepatocellular hypertrophy in male rats exposed to PFOA in the diet for 13 weeks. Goldenthal (1978b) determined an oral NOAEL o f 3 m g k g d a v in rhesus monkeys. How ever, this dose group occasionally had soft stools or moderate to marked diarrhea, and frothy emesis. Also, there were trends toward increased glucose levels, and decreased alkaline phosphatase levels in this dose group. Butenhoff. et al.. (2001) found an oral LOEL o f 3 mgkg'day based on increased liver weight in cynomolgus monkeys, which occurred at serum concentrations that overlapped those observed in some workers with high exposure; therefore the liver enlargement was considered to be a significant effect by the authors. A NOEL was not determined in this study. Because the monkey is most physiologically similar to humans, as evidenced by the long half-life o f C8 in humans (l - 3.5 years) and monkeys. This LOEL was utilized to estimate an the PRfDo as decnbed below: Calculation of the Oral Provisional Reference Dose: PRfDo = LOEL (L7H) (UFA) (UFS) (UFL) (MF) where: PRfDo = Provisional Oral Reference Dose (mg/kg/day); LOEL = Lowest Observable Effect Level (mg'kg/day) = 3; LT = Uncertainty Factors (unitless); H = intrahuman variability accounts for variation in sensitivity among the human population =10; A = animal to human extrapolation = 10; S = extrapolation from subchronic exposure to chronic exposure = 10; L = extrapolation from a LOEL to a NOEL = 10; D = insufficiency in the toxicological database * 3; MF = Modifying Factor (umtless) = 3 A modifying factor o f 3 was used because o f the following characteristics o f C8: Long half-life in humans (approximately 1 - 3 . 5 years); Potential for bioaccumulation; Potential for biopersistence; Unusual physical properties such as solubility and partition coefficient. Therefore, the PRfDo equals 3 x 10E-5. U U 4 WVDEP Calculation of the Preliminary Screening Level for C8 in Water: The PSL o f t |ig/L or ppb was calculated using a Hazard Quotient o f 1 and the following equation and default parameters: GW = (PRfDo) (BWa) (CF) ( [RWai where: GW = concentration in Groundwater (|ig/L); PRfDo = Provisional Oral Reference Dose (mg/kg/day) = 3 x 10E-5; BWa = adult body weight (kg) = 70; CF = conversion factor (from mg to |ig) =* 1000; [RWa = Ingestion Rate o f Water for an adult (L/day) =>2. Development of Provision Inhalation Reference Concentration: No monkey inhalation exposure studies have been conducted for PFOA. However, two two-week (6 hr/day; five days/week) inhalation exposure studies were conducted in rats by DuPont (1994). In the first study, a LOAEL o f 11 mg/m3was found based on decreased body weight and hepatic injury. In the second study, a NOAEL o f 1 mg m ; was determined. This NOAEL agreed with a NOAEL o f l m gm 3 found by Staples et al. (1984) in female rats during a developmental toxicity study o f PFOA. Inhalation reference doses were calculated for the NOAEL and the LOAEL as described below. Based on the LOAEL: Conversion from intermittent exposure to continuous exposure: LOAEL = E x D (h/24h) x W (days/7 days) Where: LOAEL * 11 mg/m3; E = exposure level in mg/m3; D = hours o f exposure (6); W = days o f exposure (5); Thus the continuous exposure LOAELc = 1.95 mg/m3; PRfCi = LOAELc (LTH) (UFA) (UFS) (UFL) (MF) 000*5 WVDEP where: PRfCi = Provisional Inhalation Reference Concentration (mg/m3); LOAELc = Lowest Observable Effect Level (m g n r) =11; LT = Uncertainty Factors (unitless); H = intrahuman variability accounts for variation in sensitivity among the human population =10; A = animal to human extrapolation = 10; S = extrapolation from subchronic exposure to chronic exposure = 10; L = extrapolation from a LOEL to a NOEL = 10; D = insufficiency in the toxicological database = 3; MF = Modifying Factor (umtless) = 3 A modifying factor o f 3 was used because o f the following characteristics o f C8: Long half-life in humans (approximately 1 - 3.5 years); Potential for bioaccumulation; Potential for biopersistence; Unusual physical properties such as solubility and partition coefficient. Therefore, the PRfUi equals 0.022|ig/m 3 based on the LOAEL o f 11 mg/m3. Based on the NOAEL: Conversion from intermittent exposure to continuous exposure: NOAEL = E x D (h/24h) x W (days/7 days) Where: NOAEL = l mg'tn3; E = exposure level in mg/m3; D = hours o f exposure (6); W = days of exposure (5); Thus the continuous exposure NOAELc = 0.18 mg/nr'; PRfCTi = NOAELc (UFH) (UFA) (UFS) (UTL) (MF) where: PRfCi = Provisional Inhalation Reference Concentration (mg/m3); NOAELc = No Observable Effect Level (mg/m3) = l; LT = Uncertainty Factors (unttless); H = mtrahuman variability accounts for variation in sensitivity among the human population 10; A = animal to human extrapolation = 10; S extrapolation from subchromc exposure to chrome exposure * 10; D = insufficiency in the toxicological database = 3; o tn u WVDEP MF = Modifying Factor (unitless) * 3 A modifying factor o f 3 was used because o f the following characteristics o f CS: Long half-life in humans (approximately 1 - 3.5 years); Potential for bioaccumulation; Potential for biopersistence; Unusual physical properties such as solubility and partition coefficient. Therefore, the PRfCi equals 0.02ng/m 3 based on the NOAJEL o f l m g m \ The PRfCi estimated using the NOAEL and the LOAEL are approximately equal. o m i7 WVDEP References: Butenhoff. J.L. et al. 2001. Toxicity o f ammonium perfluorooctanoate (APFO) in cvnomolgus monkeys after twenty-six weeks o f oral dosing (in preparation). DuPont Haskell Laboratory 1994 update. Toxicology review o f C8. Gilliland. F. 1992. Fluorochemicals and Human Health: Studies in an Occupational Cohort. Doctoral thesis. Division o f Environmental and Occupational Health, University of Minnesota. Gilliland. F.D. and Mandel. J.S. 1993. Mortality among employees o f a perfluorooctanoic acid production plant. JOM 35(9):950-954. Gilliland. F.D. and Mandel, J.S. 1996. Serum perfluorooctanoic acid and hepatic enzymes, lipoproteins, and cholesterol: A study o f occupational exposed men. Am. J. Ind. Med 29:560-568. Goldenthal. E.I. 1978a. Ninety Day Subacute Rat Toxicity Study. Final Report. Prepared for 3M, St. Paul, Minnesota, by International Research and Development Corporation, St. Paul, Minnesota, November 6, 1978. Goldenthal. E.I. 1978b. Ninety Day Subacute Rhesus Monkey Toxicity Study. Final Report. Prepared for 3M, St. Paul, Minnesota, by International Research and Development Corporation, St. Paul, Minnesota, November 10, 1978. 3M. 1987. Two-Year Oral (Diet) Toxicity and Carcinogenicity Study o f Fluorochemical FC-143 (Perfluorooctanane Ammonium Carboxylate) in Rats. Final Report. Vol. 1-4, 3M RIKER Exp. No. 0281CR0012; 8EHQ-1087-0394, October 16. Olsen. GW; Gilliland, FD; Burlew, MM; Burris. JM; Mandel, JS; Mandel. JH. 1998a. .An epidemiologic investigation o f reproductive hormones in men with occupational exposure to perfluorooctanoic acid. JOEM 40(7):614-622. Olsen. GW; Burris, JM; Burlew, MM; Mandel, JH. 1998b. An Epidemiologic Inv estigation o f Plasma Cholecystokinin and Hepatic Function in Perfluorooctanoic Acid Production Workers. Final Report. 3M Company. Palazzolo, M.J. 1993. Thirteen -W eek Dietary Toxicity Study with T -5180, Ammonium Perfluorooctanoate (CAS No. 3825-26-1) in Male Rats. Final Report. Laboratory Project Indentification H W I6329-100. Hazleton Wisconsin, Inc. Staples. R.E.. Burgess. B.A., and Kems, W.D. 1984. The Embryo-Fetal Toxicity and Teratogenic Potential o f Ammonium Perfluorooate (APFO) in the Rat. Fund. Appl. Tox. 4, 429-440. 000188 WVDEP R eference O ral Studies P a la r/n ln c l al. (1901) York cl at (2002) 1M (1981) 1hom ford cl al (2001 ) Inhalation Stndies Kennedy cl al ( I986)a D erm al Stndies C ritical F.fTeel l,cvcl N n n c a n c rr S c re e n in g L ev e l V a lu e s fo r C'8 Com posite RfD/ UF RfC W ater A du lt ( wr/L ) W ater C hild ( mr/L> Soil A dult (m g/kg) Soil C h ild (wg/lig) A ir (ug/m ') 0 4 7 (N ()A i:i, 100 in m ales) 0 005 mi 78 1650 191 1 (IX )A FJ, in m ales) 100 0001 HO 47 2190 215 0.42 (BM I)I. in m ales) 100 0 004 146 61 2920 111 16(IO A IX in fem ales) 1000 0 0 0 2 71 11 1460 156 0.71 (RM DL in m ales) 100 0007 256 110 5110 547 .1 (NOAF.I, in m ales) 1000 0001 no 47 2190 215 0.6 (N O A I'I, (lll-C i* in m ales) 1000 0.04 (N O A M . - M IX ',, in m ales) 1000 0 000 2 0.000 01 21 .01 WVDEP 12584 M ia s kcim cdv *1 il ( (a I 11 H A I I h i malcv) toon (I 001 a I hese studies arc not adequate for derivation of an IR IS quality R fD /R H ol m en l<m confidence I lie values shown would represen! only a provisional value, and not recommended for use as the basis of a screening level I icrivnlion ol lire R R or R ID via roule-lo-routc extrapola!ion is not supported by the available toxicokinctic data. Calculations for Screening Levels: Default Lxpostirc Parameters for calculations: Target Hazard Quotient (TIIQ): Body Weight (BW): Averaging l ime (AT): Lxpostirc Trcqucncy(T'l:): Exposure Duration (I'D): Water Ingestion Rate (IRW): Srril Ingestion Rate (IRS): 1 70 leg adult; 15 kg child 10950 days (RDx 365) 350 days/year 30 years 2 L/day adult; I l,/day child 100 mg/day adult; 200 mg/day child (iencral Assumptions: C'R's low vapor pressure and Ilenry's Law constant suggest that volatilization of C8 from water and soil is unlikely; therefore parameters estimating volatilization were not included in the screening level equations. Inadequate data exist to develop a dermal toxicity value either from dermal data or by route-to-routc extrapolation; therefore parameters estimating contribution from dermal exposure to water or soil were not included in the screening level equations. Water: RBC (ug/L) RIDx TIIQ* BW* AT* lOOOug/mg I I * I D * IRW H I VA'DEP 12585 fo r .hlnll expnsiue p it > \ 1 * 70 lll'JM) * I (Min isu* to * : - R fl) x 16500 1 or ch ilil exposure R fl) x 1 * 1 5 * 10950 * 1000 .150 * 10 * 1 = R f l)* 15641 Soi/: RIM' (mg/kg) Rfl)x 1IIO * BW * AT I l * I I) * 1RS * 10* mg/kg l or adult exposure RIDx 1* 70 *10950 150* 10 * 100 * 10* - Rff) x 710,000 Tor child exposure Rfl) x 1 * 1 5 * 10950 150 * 10 * 200 *10* = Rfl) x 78,214 Air: Note, both Region 1 and Region 9 Screening level guidance indicate that an Rfl)i. in units (*f mg/kg-day, is to be used in the air screening level calculation. The Rf!)i is obtained from the Rfl' by multiplying by the default breathing rate and dividing by the default WVDEP 12586 mm i l i ii il u n i, . U \ i l i ili ni idoli'; lor ;iit liu t i m u lh | 'l\ In (In- i K I.n il I In <K n e ij 'lit .uul l i m i l i I ' il' * " lu u l\ n v if'lil H m u - v i - i llu M u t n m v K w U . i K ' i i . u ,.| ,.| i k a m i l u e a l l m u ' r a t e s " t a n t e l n u l . llu-re ts ,l,n, ,1. n i,. . . . . . . . . . . . . motliUeil lo eliminale lite retluiulanl slep -M I <'..1.1 1 ' " ll `"m RIK' (U(i/m!) RR x MIO* Al * IOOOuE/mg I l * I I) RITx 1 10950 * 1000 350 * 30 = RIC * 1043 WVDEP 12587 000192