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~ S ~ S Taft Stettinius 5 Hollister LLP 425 Walnut Street, Suite 1800/ Cincinnati, OH 45202-3957 / Tel: 513381.2838/ Fax: 513381.0205/ www taftlaw corn Cincinnati I Cleveland I Columbus I Dayton / Indianapolis / Northern Kentucky/ Phoenix ROBERT A. BILOTT 513.357.9638 bilott@taftlaw. corn Apnl 8, 2013 BY EMAIL AND REGULAR US MAIL Bruce C. Tierney, M.D. Captain, US Public Health Service Agency for Toxic Substances and Disease Registry Chamblee Campus, Bldg. 106, Room 5018 4770 Buford Highway NE, MS F-59 Atlanta, GA 30341 Re: Health Consultation Exposure Investigation Report: Perfluorochemical Serum Sampling In the Vicinity of Decatur, Alabama Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We are writing to you on behalf of our thousands of individual clients whose residential drinking water has been contaminated with PFOA to address and correct certain statements your Agency has made to the public through the referenced Health Consultation document (the "Report" )" and associated Summary sheet, which are scientifically and factually inaccurate and/or misleading with respect to human PFOA exposures and associated health risks. In particular, we address the existing scientific literature with respect to documented and/or published adverse human health effects associated and/or linked to exposures to PFOA and recent toxicological data that has either been mischaracterized or inexplicably omitted from the Report and/or Summary. We hope that this letter will assist the Agency in promptly revising/correcting the language at issue in its Report and Summary to more accurately reflect the actual, current scientific data in this regard, so that affected residents can more accurately assess and understand any potential risks to their health from their PFOA exposures. I. Summary/Overview of PFOA Scientific Data/Developments As explained in our prior communications and submissions to your Agency over the last several years on matters relating to PFOA human health risks, (see, e.g., Ex. A), our law firm has been representing individuals with PFOA-contaminated drinking " It does not appear as if any draft or earlier version of the Report or Summary was made available to the public for review or comment, during which the types of issues addressed herein could have been resolved/avoided. 13428246.1

2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

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Page 1: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

~ S ~ S

Taft Stettinius 5 Hollister LLP425 Walnut Street, Suite 1800/ Cincinnati, OH 45202-3957 / Tel: 513381.2838/ Fax: 513381.0205/ www taftlaw corn

Cincinnati I Cleveland I Columbus I Dayton / Indianapolis / Northern Kentucky/ Phoenix

ROBERT A. BILOTT513.357.9638bilott@taftlaw. corn

Apnl 8, 2013

BY EMAIL AND REGULAR US MAIL

Bruce C. Tierney, M.D.Captain, US Public Health ServiceAgency for Toxic Substances and Disease RegistryChamblee Campus, Bldg. 106, Room 50184770 Buford Highway NE, MS F-59Atlanta, GA 30341

Re: Health Consultation —Exposure Investigation Report: PerfluorochemicalSerum Sampling In the Vicinity of Decatur, Alabama —Morgan, Lawrence,and Limestone Counties (ATSDR, April 1, 2013)

Dear Dr. Tierney:

We are writing to you on behalf of our thousands of individual clients whoseresidential drinking water has been contaminated with PFOA to address and correctcertain statements your Agency has made to the public through the referenced HealthConsultation document (the "Report" )" and associated Summary sheet, which arescientifically and factually inaccurate and/or misleading with respect to human PFOAexposures and associated health risks. In particular, we address the existing scientificliterature with respect to documented and/or published adverse human health effectsassociated and/or linked to exposures to PFOA and recent toxicological data that haseither been mischaracterized or inexplicably omitted from the Report and/or Summary.We hope that this letter will assist the Agency in promptly revising/correcting thelanguage at issue in its Report and Summary to more accurately reflect the actual,current scientific data in this regard, so that affected residents can more accuratelyassess and understand any potential risks to their health from their PFOA exposures.

I. Summary/Overview of PFOA Scientific Data/Developments

As explained in our prior communications and submissions to your Agency overthe last several years on matters relating to PFOA human health risks, (see, e.g., Ex.A), our law firm has been representing individuals with PFOA-contaminated drinking

"It does not appear as if any draft or earlier version of the Report or Summary was

made available to the public for review or comment, during which the types of issuesaddressed herein could have been resolved/avoided.

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Bruce C. Tierney, M.D.April 8, 2013Page 2

water for more than a dozen years, including serving as plaintiffs'lass counsel forapproximately 80,000 people whose drinking water supplies in Ohio and West Virginiawere contaminated by PFOA released from a nearby manufacturing facility owned andoperated by E.l. du Pont de Nemours and Company ("DuPont" ). As a result of ourclass-wide settlement of that case with DuPont in 2005 (known as the Leach v. DuPontcase), a panel of three world-renowned epidemiologists (known as the "C8 SciencePanel" ) were jointly selected by plaintiffs'lass counsel and DuPont and charged with

independently determining whether there are any "probable links" between humanexposure to PFOA and serious disease. Under the court-approved class settlementterms, once the C8 Science Panel finds any such "probable links" (defined to mean thatdisease is "more likely than not" linked to the PFOA exposure), that "probable link"

finding conclusively resolves the issue of "general causation" (defined to mean that "it isprobable that exposure to [PFOA] is capable of causing" the disease at issue) for all theaffected residents in the class. (See Ex. B, at Sections 1.25, 1.49, and 3.3.) Withrelease of the final "probable link" reports from the C8 Science Panel being completedin October of 2012, we now know that human exposure to PFOA is directly linked to:

1. Testicular Cancer;

2. Kidney cancer;

3. Ulcerative colitis;

4. Thyroid Disease;

5. Pregnancy-induced hypertension/preeclampsia; and

6. Hypercholesterolemia (medically-diagnosed high cholesterol).

As the C8 Science Panel explained in their final reports, the C8 Science Paneldid not rely on just one study or one particular population for their conclusions butperformed a type of "meta —analysis" of all of the existing data on the particular endpointat issue, including all available human studies (including both occupational and non-occupational populations), relevant animal toxicology studies, exposure studies, andpharmocokinetics data. In other words, the "probable link" conclusions were not theresult of any one, isolated study or "association" found in only one population, but werethe result of a careful assessment of a/I of the available scientific literature (from 3M,from DuPont, from EPA, from everyone else) which the panel then independentlyweighed and evaluated, as is done in typical peer review processes. That overall linkassessment process is described in the C8 Science Panel's final reports reporting the"probable links", copies of which we sent to your Agency when they were released, (seeEx. A), and each of which have all been publicly-available on the C8 Science Panel'swebsite since their release. (See www.c8sciencevanel.orq .)

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Bruce C. Tierney, M.D.April 8, 2013Page 3

Moreover, with respect to data from several of the non-occupational communitiesthat the C8 Science Panel considered within the scope of their overall "probable link"analysis and in which such "links" were found, the levels of PFOA in the

communities'rinking

water (such as in Mason County, Ohio) were only around 0.05 ppb (more than10 times lower than US EPA's current 0.4 ppb provisional health advisory ("PHA"),which, as confirmed in US EPA's own PHA document for PFOA, governs only "short-term exposures" to PFOA in drinking water.— not exposures over many years. (See Ex.C, at 3.) Thus, the C8 Science Panel considered PFOA health effects amongthousands of community members exposed to levels of PFOA similar to those found inthe West Morgan/East Lawrence water system in Alabama ("WM/EL") when it found itsprobable links with the serious diseases listed above. (See Ex. D., at 19-20 (indicatingapproximately 0.03 ppb PFOA in WM/EL water in 2009).) Alabama residents using thedrinking water wells where PFOA was found above the 0.4 ppb short-term PHA (whichwere then connected to alternative water supplies) would most likely have had evenhigher exposures.

The C8 Science Panel has not, however, been the only group generating andreviewing scientific data relating to human health effects and risks from PFOAexposures. The issue has been the subject of a significant amount of research,particularly over the last two to three years, as reflected by the numerous publicationsand papers that we have been forwarding to your Agency since 2009, after ATSDR firstattempted to assess this body of data. (See Ex. A.) For your convenience, we haveattached a chart summarizing those particular publications and papers where the actualdata has revealed one or more links between PFOA exposures and adverse humanhealth effects from PFOA exposures. (See Ex. E.)

As made clear from the attached chart of PFOA studies where such links havebeen found, PFOA has been linked by scientific research to at least the followingadditional adverse human health effects in one or more occupational and/or non-occupational populations (even though the C8 Science Panel did not find "probablelinks" with these particular diseases/outcomes):

1. Increased trig lycerides;

2. Increased uric acid;

As of today's date, no federal agency, including EPA, has released any guideline orPHA for long-term exposures to PFOA in drinking water (lasting for several years ormore), which is the more relevant exposure scenario for residents who have beenexposed to such sources for several years. Thus, neither ATSDR nor EPA has everidentified a level for PFOA in water below which is considered "safe" for any such long-term exposures. The State of New Jersey has, however, released such a long-termexposure guideline of 0.04 ppb —approximately 10 times lower than the short-tern PHAreferenced by ATSDR. (See Ex. F.)

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Bruce C. Tierney, M.D.April 8, 2013Page 4

3. Increased cardiovascular/heart disease;

4. Increased stroke/cerebrovascular disease;

5. Increased diabetes;

6. Increased prostate, pancreatic, ovarian, and breast cancers;

7. Adverse immune system effects/asthma;

8. Adverse effects on liver function;

9. Adverse effects on kidney function;

10. Adverse effects on hormone balance;

11. Adverse reproductive/developmental outcomes/birth defects;

12. Adverse neurological effects;

13. Increased pancreatic problems; and

14. Increased osteoarthritis.

We have been making an effort to promptly forward these studies to ATSDR asthey have been released, most of which have come out within the last two to threeyears. (See Exs; A and E.) It is unclear, therefore, why many of these importantstudies are not mentioned as even existing anywhere in your Report. In fact, AppendixD of your Report (which purports to provide a "Review of PFC Studies and HealthEffects" upon which ATSDR's conclusions on such health issues are drawn forpurposes of the Report), does not even mention or list a single study/paper/publicationfrom within the last 2 years. (See Report, at App. D (the most recent listed reference isfrom 2011).) That "review" also fails to even mention most of the important humanhealth effects studies relied upon by the C8 Science Panel to confirm serious diseaselinks with PFOA, and appears to have been written several years earlier, rendering itoutdated and inaccurate.

As made clear in the chart of available data finding links between PFOA exposuresand adverse human health effects, increased cancer rates, specifically includingincreased prostate and kidney cancers, have been found by even 3M and DuPont inpublished/peer reviewed studies of their own occupational workers —not just incommunity settings. (See Ex. E, at 8-11.)

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Bruce C. Tierney, M.D.April 8, 2013Page 5

II. ATSDR Should Correct/Revise its Report and Summary to Reflect theCorrect Human Health Data for PFOA.

Although review of the information referenced above and attached hereto shouldclarify the general scope and nature of the types of revisions/changes that arenecessary to insure that the information regarding PFOA human health effectscontained in ATSDR's Report (including a complete rewrite and update of Appendix D)and Summary is not inaccurate or misleading, we specifically request that ATSDRcorrect at least the following specific statements:

A. Report Statements

All references to the 0.4 ppb PHA for PFOA throughout theReport should be qualified to make clear that the existingPHA is only a PHA for "short-term exposures," and clarifythat there is no existing long-term PHA from either EPA orATSDR.

On page 7, ATSDR states that only "[t]hree recent studies"have found "possible" links with PFOA health effects. Asnoted above, there are far more than three such studies andfar more than three links. Moreover, the "links" that werefound by the C8 Science Panel were "probable" links (morelikely than not) —not just merely "possible" links. Many ofthe other associations/links found in the cited literature byother researchers were coupled with even strongerassertions of causality.

On page 19, ATSDR states that "PFCs have been shown tohave health effects on animals" but only "at serumconcentrations that are higher than observed in humanexposure studies" or at "doses that are higher than havebeen observed in the general human population." Thosestatements are incorrect. For example, one of

NIEHS'ecent

published, peer-reviewed studies showed significantadverse effects in animals exposed to PFOA in their drinkingwater at levels "approximating those found in human watersupplies." (See White, S.S.,et al, "Gestational and chroniclow-dose PFOA exposures and mammary gland growth anddifferentiation in three generations of CD-1 mice," 119 (8)Environ. Health Perspec.1070-6 (Aug. 2011).)

4. In its discussion of the C8 Science Panel "probable link"

results, ATSDR fails to even mention the Panel's finding of aprobable link between PFOA exposure and

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Bruce C. Tierney, M.D.April 8, 2013Page 6

hypercholesterolemia (medically-diagnosed highcholesterol). ATSDR also implies that the Panel's work iscontinuing, which it is not. The C8 Science Panel completedits work with release of its final reports in October 2012 andhas been disbanded.

Summary Sheet Statements

As with the Report, in each place that ATSDR refers to theexisting 0.4 ppb PHA, it should clarify that the PHA is forshort-term exposures only and that neither US EPA norATSDR has any PHA for longer-term exposures.

On page 4, ATSDR refers to the existing human healthstudies as revealing nothing more than "several recentstudies" showing only a "possible" link to adverse healtheffects. As noted above, that statement is misleading in thatit significantly underestimates the number of studies actuallyfinding links dating back many years, and is inaccurate to theextent it refers to any of the C8 Science Panel final linkreports, which found "probable" (more likely than not) links-not the mere "possibility" of such links.

Also on page 4, ATSDR states that adverse effects haveonly been found in laboratory animals exposed to PFQA "atmuch higher levels than the levels found in thisinvestigation." It is not clear if ATSDR considered the lowdoses at issue in the White paper referenced above beforemaking that statement.

ATSDR also states on page 4 that "research has not clearlyshown that PFCs are related to specific illnesses" inhumans. That statement (as confirmed by all the studieslisted and/or referenced in Exs. A and E) is not accurate.The C8 Science Panel, for example, found probable linkswith several serious diseases (as mentioned and identifiedabove) after spending more than seven years peer reviewingall the available evidence —human, animal, and otherwise-and carefully evaluating the entire body of evidence from allsources before rendering their ultimate independent findingsas to the links with disease. If this type of independent peerreview and meta-analysis is not sufficient for ATSDR to

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Bruce C. Tierney, M.D.April 8, 2013Page 7

acknowledge a link, ATSDR needs to explain what more it

needs (short of direct human experimentation).

5. On page 5, ATSDR provides an outdated and inaccuratedescription of the work of the C8 Science Panel. As notedabove, this work and related studies were all completed lastyear and all the final link reports have been released—nothing is still on-going.

On page 5, ATSDR incorrectly represents to the public that"[n]one" of the occupational exposure studies involvingworkers exposed to PFOA "have found a link betweenexposures to PFCs and cancer." That statement is notaccurate. As made clear in the papers cited/referenced in

Exs. A and E, both 3M and DuPont, for example, havereported links between PFC exposures and cancer(including prostate and/or kidney cancers) in their ownworkers through published, peer reviewed papers. It is notclear why ATSDR has ignored those studies.

We look forward to receiving a copy of ATSDR's written corrections addressingthe inaccurate and/or misleading statements referenced above.

ly yours,

obert A. Bilo

RAB:mdmExhibitsCC: Elizabeth A. Doyle (USEPA) (w/Exs.)

Joyce Donahue (USEPA ) w/Exs.)

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A

Page 9: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

Taft Stettinius 8 Hollister LLP

425 Walnut Street, Suite 1800/Cincinnati, OH 45202-3957 /Tel: 513.381.2838/Fax: 513.381.0205/www.taftlaw.cornCincinnati /Cleveland /Columbus /Dayton /indianapolis /Northern Kentucky /Phoenix /Bering

ROBERT A. BTLOTT

[email protected]

October 30, 2009

VIA ELECTRONIC AND REGULAR U.S. MAlL

Ms. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Comment On Draft Toxicological Profile ForPerfluoroalkyls

Ms. Roney:

On behalf of our clients in various States whose residential drinking water iscontaminated with one or more perfluoroalkyls, including PFOA and/or PFOS, and in

response to ATSDR's July 23, 2009, Federal register notice, we are submitting thefollowing comments on ATSDR's Draft Toxicological Profile for Perfluoroalkyls {the"Profile" ). In general, we believe that the current draft Profile inappropriately down-playsthe significance of the available data confirming significant risks of adverse healtheffects among humans exposed to one or more perfluoroalkyls, particularly amongperfluoroalkyl workers and those living near industrial sources of perfluoroalkyls thathave contaminated nearby drinking water supplies.

Although we recognize that research relating to the potential adverse healtheffects of perfluoroalkyls is on-going and will be continuing for quite some time, webelieve that there is a considerable amount of recent data that does not appear to havebeen considered within the scope of the existing draft Profile that should be before theProfile is finalized. In particular, recently-published studies of perfluoroalkyl workershave strengthened and reaffirmed the consistency of associations previously reportedbetween perfluoroalkyl exposure and adverse health outcomes, and new studies of tensof thousands of community residents exposed to perfluoroalkyls in their drinking water,including new published, peer-reviewed articles, confirm similar and additionalassociations at even lower internal serum levels. We believe this additional datarenders inaccurate and misleading statements in the current draft Profile such as "long-term exposure to perfluoroalkyls at work has not been associated with significant

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Ms. Nickolette RoneyOctober 30, 2009Page 2

adverse health effects"" and that the available data on "people whose drinking watercontained perfluoroalkyls did not find problems."'n behalf of our clients, we requestthat all portions of the draft Profile be revised to the extent necessary to thoroughly andproperly reflect the impact of this more-recent data now available through the followingpublications, studies, and reports

1, Lundin, J.l., et al., "Ammonium Perfluorooctanoate Production and OccupationalMortality." 20 Epidem. 921-28 {Nov. 2009);

2. West Virginia University, "C-8 Health Project Results," (available online Oct. 30,2009 at www.hsc.wvu.edu/som/cmed/c8/results/index.asp );10/

C-8 Science Panel, "Status Report: Association of Perfluorooctanoic Acid(C8/PFOA) and Perfluorooctane Sulfonate (PFOS) With Lipids Among Childrenin the Mid-Ohio Valley," {available online at www.c8sciencepanel.or@ ) (Oct. 28,2009);

Steenland, K., et al., "Association of Perfluorooctanoic Acid (PFOA} andPerfluorooctane Sulfonate (PFOS) with Uric Acid Among Adults with ElevatedCommunity Exposure to PFOA," Environ. Health Persp. (online doi:10.1289/ehp/0900940 {Oct. 22, 2009)};

Bartell. S.M., et al., "Rate of Decline in Serum PFOA Concentrations AfterGranular Activated Carbon Filtration at Two Public Water Systems in Ohio andWest Virginia," Environ. Health Persp. (online doi: 10.128S/ehp.0901252 (Oct.22, 2009));

6. Steenland, K., et al., "Association of Perfluorooctanoic Acid and PerfluorooctaneSulfonate With Serum Lipids Among Adults Living Near A Chemical Plant," Am.J. Epi dam. (online doi:10.1093/aje/kwp279 (Oct. 21, 2009));

7. Dallaire, R,, et al., "Thyroid Function And Plasma Concentrations OfPolyhalogenatal Compounds ln lnuit Adults," 117(9)Environ. Health Persp.1380-86 (Sept. 200S);

"Draft Profile, at 4./d.

Because all of these materials are available either in the published literature, have been submitted intopublic files (including USEPA public dockets EPA-HQ-OPPT-2203, AR-226, EPA-HQ-ORD-2003-00'i 6,and/or TSCA 8{e)),or are available through public websites sponsoring the work (such as the DuPontPFOA MOU peer review work), we have not enclosed additional copies of any of these materials. Pleaselet us know, however, if the Agency is unable to locate any of the documents and would like for us toforward a copy.

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Ms. Nickolette RoneyOctober 30, 2009Page 3

10.

12.

13.

14.

16.

17.

18.

Stein, C.R., et al., "Serum Levels of Perfluorooctanoic Acid and PerfluorooctaneSulfonate and Pregnancy Outcome." Am. J, Epidem. (onlinedoi:10.1093/aje/kwp212 (Aug. 19, 2009});

MacNeil, J., et al., "A Cross-Sectional Analysis of Type II Diabetes ln ACommunity With Exposure To Perfluorooctanoic Acid (PFOA)," Environ. Res.(online doi.10.1016/j.envres.2009.08.002 (Aug. 2009)};

Minnesota Department of Health, "East Metro Perfluorochemcial BiomonitoringPilot Project" (available online atwww.health. state.mn.us/divs/eh/hazardous/tonics/pcs/index. html} (July 21,2009);

"Final Report of the Peer Consultation Panel: Scientific Peer ConsultationProcess For A Site Environmental Assessment Program as Part of the DuPont-EPA Memorandum of Understanding and Phase II Workplan" {available online athttp: //itp-pfoa.ce.cmu.edu/) (July 15, 2009);

Steenland, K., et al., "Predictors of PFOA Levels In A Community Surrounding AChemical Plant." 117 Environ. Health Persp. 1083-88 {July 2009);

Frisbee, S.J.,et al., "The C8 Health Project: Design, Methods, and Participants,"Environ. Health Persp. (online doi:10.1289/ehp.0800379 (July 13, 2009));

Sakr, C.J.,et al,, "Ischemic Heart Disease Mortality Study Among Workers WithOccupational Exposure To Ammonium Perfluorooctanoate," Occp. Environ. Med.(online doi:10.1136/oem.2008.041582 (June 23, 2009);

Fenton, S.E.,et al., "Analysis Of PFOA In Dosed CD-1 Mice Part 2: DispositionOf PFOA tn Tissues And Fluids From Pregnant And Lactating Mice And TheirPups," Reprod. Toxico/. (online doi:10.1016/j.reprotox.2009.02.012 {2009));

von Ehrenstein, O.S., et al., "Perfluoroalkyl Chemicals In The Serum And Milk OfBreastfeeding Women," Reprod. Toxicol. (onlinedoi:10.1016/j.reprotox.2009.03.001 (2009));

Hines, E.P., et al., "Phenotypic Dichotomy Following Developmental Exposure ToPerfluorooctanoic Acid (PFOA) In Female CD-1 IVlice: Low Doses InduceElevated Serum Leptin And insulin, And Overweight In Mid-I ife." 304 Molecular8 Cellular Endocrinology 97-105 (2009);

Guyton, K.Z., et al., "A Reexamination of the PPAR-a Activation Mode of Actionas a Basis for Assessing Human Cancer Risks of Environmental Contaminants,"Environ. Health Persp. (online doi: 10.1289/ehp.0900758 (May 15, 2009));

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Ms. Nickolette RoneyOctober 30, 2009Page 4

19. Post, G.B.,et al., "Occurrence And Potential Significance Of PerfluorooctanoicAcid (PFOA) Detected In New Jersey Public Drinking Water Systems." 43(12)Environ. Sci. Techno'. 4547-54 (May 8, 2009));

20. C-8 Science Panel, "Status Report: PFOA And Immune Biomarkers In AdultsExposed To PFOA In Drinking Water fn The Mid Ohio Valley" (available online atwww.c8sciencepanel.org }(March 16, 2009);

21. Costa, G., et al., "Thirty Years Of Medical Surveillance In Perfluorooctanoic AcidProduction Workers," 51 J.O.E.M. 1-9 (March 2009);

22. Joensen, U.N., et al., "Do Perfluoroalkyl Compounds Impair Human SerumQuality?" Environ, Health Persp. (online doi:10.1289/ehp.0800517 (March 2,2009)};

23 Kato, K., et a!., "Polyfluoroalkyl Compounds In Pooled Sera From ChildrenParticipating ln The National Health And Nutrition Examination Survey 2001-2002," Eviron. Sci. Technol. (online doilabs/1 0.1021/es803156p (Feb. 19, 2009});

Fei, C., et al., "Maternal Levels Of Perfluorinated Chemicals And Subfecundity,"1 Hum. Reprod. 1-6 {January 28, 2009);

25. Minnesota Pollution Control Agency, "PFCs In Minnesota's AmbientEnvironment: 2008 Progress Report" (available online atwww.pca.state.mn.us/cleanup/ofclindex.html) {Jan. 2009);

26. Chen-Yu Lin, et al., "Association Among Serum Perfiuoroalkyl Chemicals,Glucose Homeostasis and Metabolic Syndrome In Adolescents And Adults,"Diabetes Care (online December 29, 2008);

27. Monroy, R., et al., "Serum Levels Of Perfiuoroalkyl Compounds In HumanMaternal And Umbilical Cord Blood Samples," 108(1)Environ. Res. 56-62 {Sept.2008);

28, Anderson-Mahoney, P., et al., "Self-Reported Health Effects Among CommunityResidents Exposed to Perfluorooctanoate," 18{2)New Solutions 129-43 (2008);

29. Vieira, V., et al., "PFOA Community Health Studies: Exposure Via DrinkingWater Contaminated By A Teflon Manufacturing Facility" (Abstract 2008);

30. White, S., et al., "Eftects Of Perfluorooctanoic Acid On Mouse Mammary GlandDevelopment and Differentiation Resulting From Cross-Foster And RestrictedGestational Exposures," Repro. Toxicol. (onlinedoi:10.1016/j.reprotox.2008.11.054 (2008)); and

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Ms. Nickolette RoneyOctober 30, 2009Page 5

31. DeWitt, Jr., et al., "immunotoxicity Of Perftuorooctanoic Acid And PerfiuorooctaneSulfonate And The Role Of Peroxisome Proliferator-Activated Receptor Alpha,"Critical Rev. In Toxico/. (online doi:10.1080/1 0408440802209804 (2008)).

ln addition to the heaith and toxicology data referenced above, we recognize thatthe Agency also has specifically requested "any additional studies, particularlyunpublished data" that might be of use to the Agency as it finalizes its Profile. in thatregard, we believe the Agency should consider and incorporate all available datareflecting levels of perfluoroalkyis in the serum/blood of residents exposed to thechemicals in their drinking water, even if that data is not formally published or peer-reviewed. On that issue, our law firm has submitted voluminous data to USEPA overthe last several years confirming the levels of PFOA, PFOS, and other perfluoroalkylsdetected in the serum/blood of residents in West Virginia, Ohio, Minnesota, and NewJersey whose residential source of drinking water has been contaminated with one ormore perfluoroalkyls. A listing of several of those letters to USEPA (each of which ispublicly-available in one or more USEPA public dockets, such as AR-226, EPA-HQ-OPPT-2003, and/or TSCA 8(e), along with the supporting analytical data sheets (withnames redacted for privacy)) follows:

Letter from R. Bilott to C. Aver, et al. Re: PFOA-ExposedCommunity Blood Sample Results —Lubeck PSD, Washington,County, West Virginia (Sept. 15, 2004);

Letter from R. Bilott to C. Auer, et al. Re: PerfluorochemicalResidential Exposure Data For Washington County, Minnesota(May 12, 2005);

Letter from R. Bilott to C. Auer, et al. Re: PerfluorochemicalResidential Exposure Data For Washington County, Minnesota(Oct. 20, 2005);

Letter from R. Bilott to C. Auer, et al, Re: PerfluorochemicalResidential Exposure Data For Washington County, Minnesota(Jan. 13, 2006);

i etter from R. Bilott to C. Auer, et al. Re: PerfluorochemicalResidential Exposure Data For Washington County, Minnesota(Feb. 2, 2007);

Letter from R. Bilott to C. Auer, et al. Re: Perfluorochemical BloodExposure Data For New Jersey (April 16, 2007); and

To assist in retrieving the letters and supporting data from the public files, we have enclosed additionalcopies of the text of these letters.

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Ms. Nickolette RoneyOctober 30, 2009Page 6

Letter from R. Bilott to C. Auer, et al. Re: PFOA/C-8 Blood LevelsFrom Ohio/West Virginia Drinking Water Contamination (April 9,2008).

We appreciate the opportunity to provide these comments and to submitthis additional data for consideration and incorporation into any final Profilereleased by the Agency for perfluoroalkyls. We hope that such information willassist the Agency in promptly developing and releasing to the public a MinimalRisk Level to help ensure the protection and safety of our clients'rinking water.

Ve truly urs,

Robert A. Bilott

RAB:mdmEnclosures

Page 15: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

Taft Stettinius 8 Hollister LLP

425 Walnut Street, Suite 1800/Cincinnati, OH 45202-3957 /Tel: 513.38'l.2838 /Fax: 513.381.0205/www.taftlaw.corn

Cincinnati /Cleveland /Columbus / Dayton /indianapolis /Northern Kentucky /Phoenix /8eijing

ROBERT A BILOTT

[email protected]

November 3, 2009

VIA ELECTRONIC AND REGULAR U.S. MAlL

Ms. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, 2009, comments on the referenced draftToxicological Profile For Perfluoroalkyls, we wish to include references to threeadditional documents that we believe should be reviewed and considered beforefinalizing the current draft Profile:

1. Nelson, J.W., "Exposure to Polyfluoroalkyl Chemicals and Cholesterol, BodyWeight, and insulin Resistance in the General U.S. Population," Environ HealthPersp. (online doi: 10.1289/ehp.0901165 (Nov. 2, 2009));

2. Hoffman, K., et al., "Exposure to Polyfluoroalkyl Chemicals and Attention DeficitHyperactivity Disorder in U.S. Children Aged 12-15 Years," 20 (6) Epidem. S70(Nov. 2009) (lSEE 2009 Conference Abstract/Poster); and

3. Pinney, S.M., et al., "Perfluorooctanoic Acid (PFOA) and Pubertal Maturation in

Young Girls," 20 (6) Epidem. S80 (Nov. 2009) (lSEE 2009 ConferenceAbstract/Poster).

Although these materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to peopleexposed to perfluoroalkyls, we believe that consideration of these materials is in the

11532654.1

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Ms. Nickolette RoneyNovember 3, 2009Page 2

best interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

~~tt'uly y

obert A. Bilott

RAB mdmEnclosures

Page 17: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

Taft Stettinius & Hollister LLP

425 Walnut Street, Suite 1800/ Cincinnati, OH 45202-3957 / Tei: 513.381.2838/Fax: 513.381.0205/www taftlaw cornCinonnati / Cl eve!and / Columbus / Dayton / Indianapolis / Northern Kentucky / Phoenix / Beijing

ROBERT A. BILOTT

513 [email protected]

January 21, 2010

YIA ELECTRONIC AND REGULAR U.S. MAIL

Ms Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, and November 3, 2009, comments on thereferenced draft Toxicological Profile For Perfluoroalkyls, we wish to include referencesto two additional documents that we beiieve should be reviewed and considered beforefinalizing the current draft Profile:

1. Lin, C.-Y., et al., "investigation of the Association Between Low-Dose SerumPerfluorinated Chemicals and Liver Enzymes in US Adults," Am. J.Gastroenterology (online doi: 10.1038/ajg.2009.707) (Dec. 15, 2009); and

2. Melzer, D., et al., "Association Between Serum Perfluorooctanoic Acid (PFOA)and Thyroid Disease in the NHANES Study," Environ. Health Persp., (online doi:10.1289/ehp.0901584) (Jan. 20, 2010).

Although these materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of the

. general public." As these new materials relate to potential health risks to peopleexposed to perfluoroalkyls, we believe that consideration of these materials is in the

11617376.1

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Ms. Nickolette RoneyJanuary 21, 2010Page 2

best interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

truly yo

(a-~ . Robert A. Bilott

RAB:mdmEnclosures

Page 19: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

3Taft Stettinius 8 Hollister LLP

425 Walnut Street, Suite 1800/ Cincinnati, OH 45202-3957 / Tel: 513 381.2838/ Fax'13 381.0205 /www taftlaw cornCincinnab / Cleveland / Columbus! Dayton / Indianapolis / Northern Kentucky / Phoenix / Beijing

RO8ERT A 6ILOTT513.357.9636biio tata ftla w.

corn

September 19, 2011

VIA ELECTRONIC AND REGULAR U.S. MAIL

Ms. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, 2009, November 3, 2009, and January 21,2010, comments on the referenced draft Toxicological Profile For Perfluoroalkyls, wewish to include references to the following additional documents/data that we believeshould be reviewed and considered before finalizing the current draft Profile:

1, Hoffman, K., et al., "Exposure to Polyfluoroalkyl Chemicals and Attention DeficitHyperactivity Disorder in U.S. Children Aged 12-15 Years," Environ. HealthPersp. {doi 10.1289/ehp.1001898) {on-line June 15, 2010);

2. Frisbee, S.J.,et al., "Perfluorooctanoic Acid, Perfluorooctane Sulfonate, andSerum Lipids in Children and Adolescents," 164 Arch. Pediatr. Ado/esc. Med. (9)860-69 (Sept. 2010);

3. Lopez-Espinosa, M.J., et al., "Association of Perfluorooctanoic Acid (PFOA) andPerfluorooctane Sulfonate (PFOS) with Age of Puberty among Children Livingnear a Chemical Plant," Environ. Sci. & Techno/. (doi:10.1021/es1038694) (on-line May 2, 2011) (9/11 ISEE 2011 presentation slides attached at Exhibit A);

4. Stein, C.R. & Savitz, D.A., "Serum Perfluorinated Compound Concentration andAttention Deficit/Hyperactivity Disorder in Children Aged 5 to 18 Years," Environ.Health Persp. {doi:10.1289/ehp.1003538) (on-line June 10, 2011) (9/1 1 ISEE2011 Presentation Slides attached at Exhibit B);

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Ms. Nickolette RoneySeptember 19, 2011Page 2

5. Knox, S.S.,et al., "Implications of Early Menopause in Women Exposed toPerfluorocarbons," 96 J. Clin Endoenno/. Metab. (6) (doi:10.1210/jc.2010-2401)(on-line March 16, 2011);

lnnes, K.E., et al., "Association of Osteoarthritis with Serum Levels ofEnvironmental Contaminants Perfluorooctanoate and Perfluorooctane Sulfonatein a Large Appalachian Population," Am, J. Epidem. (doi:10.1093/aje/kwrl 07)(on-line June 2?, 2011);

7. C-8 Science Panel, "Status Report: The mortality of DuPont workers in relationto exposure to PFOA (C8)," {available on-line at www.c8sciencepanel.orq) (July15, 20'l1) (9/11 ISEE 2011 presentation slides attached at Exhibit C);

C-8 Science Panel, "Status Report: Serum PFOA and liver function markers inthe blood of adults in the Mid-Ohio Valley," (available on-line atwww.c8scienceoanel.or@ ) (July 15, 2011) (9/11 ISEE 2011 presentation slidesattached at Exhibit D);

C-8 Science Panel, "Status Report: PFOA (C8) exposure and pregnancyoutcome among participants in the C8 Health Project," {available on-line atwww.c8scienceoanel.oro) (July 15, 2011) (9/11 ISEE 2011 presentation slidesattached at Exhibit E);

10. Knox, S S., et al., "Perfluorocarbon exposure, gender and thyroid function in theC8 Health Project," 36 (4) J. Toxico/. Sci. 403-410 (Aug. 2011);

11. C-8 Science Panel, "Status Report. Serum PFOA and Markers of ThyroidFunction in Children in the Mid-Ohio Valley," (available on-line atwww.c8sciencepanel,org) {Aug. 11, 2011) (9/11 ISEE 2011 poster attached atExhibit F); and

12; Shankar, A &, Ducatman, A., "Perfluoroalkyl Chemicals and Chronic KidneyDisease in U.S. Adults," Am. J. Epidem. {doi:10.1093/aje/kwr1 71) (on-line Aug.26, 2011).

Although these materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to people

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Ms. Nickolette RoneySeptember 19, 2011Page 3

exposed to perfluoroalkyls, we believe that consideration of these materials is in thebest interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

Ve truly

rRobe A. Bilott

RAB:mdmEnclosurescc: Elizabeth A. Doyle (USEPA) (w/encls.)

Joyce Donahue (USEPA) (w/encls.)

Page 22: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

8Taft Stettinius & Hollister LLP

425 Walnut Street, Suite 1800/ Cincinnati, OH 45202-3957/ Tel: 513.381.2838/ Fax: 513.381.0205/ www taftiaw cornCincinnati / Cleveland / Columbus / Dayton / Indianapolis / Northern Kentucky / Phoenix

ROBERT A, [email protected]

January 17, 2012

YIA ELECTRONIC AND REGULAR U.S. MAIL

Ms. Nickoiette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, 2009, November 3, 2009, January 21, 2010,and September 19, 2011, comments on the referenced draft Toxicological Profile ForPerfluoroalkyls, we wish to include references to the following additionaldocuments/data that we believe should be reviewed and considered before finalizingthe current draft Profile:

1. Shankar, A. et al., "Perfluoroalkyl chemicals and elevated serum uric acid in

adults," 3 Clin. Epidem. 251-58 (Sept. 2011);

2. Bonefeld-Jorgensen, E.C.,et al., "Perfluorinated compounds are related to breastcancer risk in Greenland Inuit: A case control study," 10:88Environ. Health 2011(doi: 10.1186/1476-069X-10-88) (on-line 10/6/1 1);

3. C-8 Science Panel, "Probable.Link Report: Probable Link Evaluation ofPregnancy Induced Hypertension and Preeclampsia," (available on-line atwww. c8scienceoanel.os) (Dec. 5, 2011);

4. C-8 Science Panel, "Status Report: PFOA and adult thyroid disease in the mid-Ohio Valley," (available on-line at www.c8sciencenanel.os) (Dec. 5, 2011);

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Ms. Nickolette RoneyJanuary 17, 2012Page 2

5. C-8 Science Panel, "Status Report: Prospective study of reproductive healthoutcomes in the mid-Ohio Valley," {available on-line at www.c8sciencepanel.os)(Dec. 5, 2011); and

6. C-8 Science Panel, "Status Report: Changes in serum PFONPFOS and serumlipids between 2005 and 2010 in the mid-Ohio Valley," (available on-line atwww.c8sciencepanel.os) {Dec.5, 2011).

Although these materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to peopleexposed to peifluoroalkyls, we believe that consideration of these materials is in thebest interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

..~erygtr Iy yours

Robert A. Bilott

RAB:mdrncc: Elizabeth A. Doyle (USEPA)

Joyce Donahue (USEPA)

Page 24: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

3Taft Stettinius 5 Hollister LLP

425 Walnut Street, Suite 1800/ Cincinnati, OH 45202-3957/ Tel: 513.381.2838/ Fax: 513.381.0205/ www.taftlaw.cornCincinnati/ Cleveland / Columbus / Dayton/ Indianapolis/ Northern Kentucky/ Phoenix

ROBERT A. 13ILOTT

[email protected]

February 6, 2012

VIA ELECTRONIC ANO REGULAR U.S. MAIL

Ms. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Taxies Substances and Disease RegistryMailstop; F-621600 Cliffon Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, 2009, November 3, 2009, January 21, 2010,September 19, 2011, and January 17, 2012, comments on the referenced draftToxicological Profile For Perfluoroalkyls, we wish to include references to the followingadditional documents/data that we believe should be reviewed and considered beforefinalizing the current draft Profile:

1. Grandjean, P., ef al., "Serum Vaccine Antibody Concentrations in ChildrenExposed to Perfluorinated Compounds," 307 (4) J.A.M.A. 391-97 (Jan. 25, 2012);

2. Gallo, V., et ai., "Serum Perfluorooctanoate (PFOA) and PerfluorooctaneSulfonate (PFOS) Concentrations and Liver Function Biomarkers in a Populationwith Elevated PFOA Exposure," Environ. Health Perspec.(dx.doi.org/1 0.1289/ehp.1104436) (on-line Jan. 30, 2012); and

3. Halldorsson, T. I., et ai,, "Prenatal Exposure to Perfluorooctanoate and Risk ofOverweight at 20 Years of Age: A Prospective Cohort Study," Environ. HealthPerspec. (dx.doi.org/1 0.1289/ehp.1104034) (on-line Feb. 3, 2012).

Although these materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to people

116173/6.1

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Ms. Nickolette RoneyFebruary 6, 2012Page 2

exposed to perfluoroalkyls, vve believe that consideration of these materials is in thebest interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

Very ruly y s,

+kJ~ Robert A. Bilott

RAB:rndmcc: Elizabeth A. Doyle (USEPA)

Joyce Donahue (USEPA)

Page 26: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

Taft Stettinius & Hollister LLP

/125 Walnut Street, Suite 1800 / Cinonnati, OH 45202-3957 / Tel: 513.381.2838/ Fax: 513.381.0205/ www taftlawcomCinonnati / Cleveland / Columbus / Dayton / Indianapolis / Nortliern Kentucky / Phoenix

ROBERT A. BILOTT

[email protected]

April 20, 2012

VIA ELECTRONIC AItID REGULAR U.S. MAIL

Ms. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, 2009, November 3, 2009, January 21, 2010,September 19, 2011, January 17, 2012, and February 6, 2012, comments on thereferenced draft Toxicological Profile For Perfluoroalkyls, we wish to include referencesto the following additional documents/data that we believe should be reviewed andconsidered before finalizing the current draft Profile:

1 C-8 Science Panel Probable Link Report: "Probable Link Evaluation of Diabetes"(April 13, 2012); and

2. C-8 Science Panel Probable Link Report: "Probable Link Evaluation of Cancer"(April 15, 2012).

Although these materials became available after the October 30, 2009, public commentdeadline, we riote that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to peopleexposed to perfluoroalkyls, we believe that consideration of these materials is in the

11617376.1

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Ms. Nickolette RoneyApril 20, 2012Page 2

best interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

Very truly yours,

RAB:mdmcc: Elizabeth A. Doyle (USEPA)

Joyce Donahue (USEPA)

Page 28: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

Taft Stettinlus 8 Hollister LLP

425 Walnut Street, Suite 1800/ Cincinnati, OH 452023957 / Tel: 5133812838/ Fax: 5133810205/ www taftlaw cornCincinnati / Cleveland / Columbus / Dayton / fndianapofis / Northern Kentucky / Phoenix

ROBERT A. [email protected]

August 14, 2012

VIA ELECTRONIC AND REGULAR U.S. MAIL

Ms. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, 2009, November 3, 2009, January 21, 2010,September 19, 2011, January 17, 2012, February 6, 2012, and April 20, 2012,comments on the referenced draft Toxicological Profile For Perfluoroalkyls, we wish toinclude references to the following additional documents/data that we believe should bereviewed and considered before finalizing the current draft Profile:

1. C-8 Science Panel Probable Link Report: "Probable Link Evaluation of ThyroidDisease" (July 30, 2012); and

2. C-8 Science Panel Probable Link Report: "Probable Link Evaluation ofAutoimmune Disease*'July 30, 2012).

Although these materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to peopleexposed to perfluoroalkyls, we believe that consideration of these materials is in the

12983641.1

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Ms. Nickolette RoneyAugust 14, 2012Page 2

best interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

truly yours

Robert A. ilott

RAB:rndmcc: Elizabeth A. Doyle (USEPA)

Joyce Donahue {USEPA)

Page 30: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

Taft Stettinius & Hollister LLP

425 Walnut Street, Suite 1800/ Cincinnati, OK 452023957 / Tel: 5133812838/ Fax: 5133810205 / www taftlawcomCincinnati / Cleveland / Columbus / Dayton / Indianapolis / Northern Kentucky / Phoenix

ROBERT A. [email protected]

November 28, 2012

VIA ELECTRONIC AND REGULAR U.S. WIAIL

IVls. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton.Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253; Supplemental Comment On DraftP

Ms. Roney:

As a supplement to our October 30, 2009, November 3, 2009, January 21, 2010,September 19, 2011, January 17, 2012, February 6, 2012, April 20, 2012, and August14, 2012, comments on the referenced draft Toxicological Profile For Perfluoroalkyls,we wish to include references to the following additional documentsldata that we believeshould be reviewed and considered before finalizing the current draft Profile:

C-8 Science Panel Probable Link Report: "Probable Link Evaluation for heartdisease (including high blood pressure, high cholesterol, coronary arterydisease)" (October 29, 2012).

Although these materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to peopleexposed to perfluoroalkyls, we believe that consideration of these materials is in the

13176507.1

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Ms. Nickolette RoneyNovember 28, 2012Page 2

best interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

Very truly yours,

Robert A. Bilott

RAB:mdmcc: Elizabeth A. Doyle {USEPA)

Joyce Donahue (USEPA)

Page 32: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

~ W ~ W~ ~

Taft Stettinius 8 Hollister LLP425 Walnut Street, Suite 1800/ Cincinnati, OH 45202-3957/ Tel: 513.381.2838/ Fax: 513.381.0205/ www.taftlaw.corn

Cincinnati / Cleveland / Columbus / Dayton / Indianapolis / Northern Kentucky / PhoenIx

ROBERT A. BILOTT

[email protected]

January 9, 2013

VIA ELECTRONIC AND REGULAR U.S. MAIL

Ms. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, 2009, November 3, 2009, January 21, 2010,September 19, 2011, January 17, 2012, February 6, 2012, April 20, 2012, August 14,2012, and November 28, 2012, comments on the referenced draft Toxicological ProfileFor Perfluoroalkyls, we wish to include references to the following additionaldocuments/data that we believe should be reviewed and considered before finalizingthe current draft Profile:

1. Javins, B., et al., "Circulating Maternal Perfluoroalkyl Substances during- Pregnancy in the C8 Health Study," Environ. Sci. 8 Tech. (doi:

10.1021/es3028082) .(on-line Jan. 7, 2013);

2. Dong, G-H., et al., "Serum Polyfluoroalkyl Concentrations, Asthma Outcomes,and Immunological Markers in a Case-Control Study of Taiwanese Children,"Environ. Health Perspec. (dx.doi.org/10.1289/ehp.1205351) (on-line Jan. 8,2013); and

3. Vieira, V;M., et al., "Perfluorooctanoic Acid Exposure and Cancer Outcomes in aContaminated Community: A Geographic Analysis," Environ. Health Perspec.(dx.doi.org/10.1289/ehp.1205829) (on-line Jan. 8, 2013).

Although these'materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after the

13235536.1

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Ms. Nickolette. RoneyJanuary 9, 2013Page 2

public comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to peopleexposed to perfluoroaikyls, we believe that consideration of these materials is in thebest interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you,

tru urs,

Robert A. Bi[ott

RA8:mdmcc; Elizabeth A. Doyle (USEPA)

Joyce Donahue (USEPA)

Page 34: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

a":Taft Stettinius 8 Hollister LLP

425 Walnut Street, Suite 1800 / Cincinnati, OH 45202-3957 / Tel: 513.381.2838/ Fax: 513 381.0205/ www taftlaw cornCincinnati / Cleveland / Columbus / Dayton / Indianapolis / Northern Kentucky / Phoenix

RQBERT A. EITLQTT

[email protected]

January 30, 2013

YIA ELECTRONIC AND REGULAR U.S. NIAIL

Ms. Nickolette RoneyDivision of Toxicology and Environmental MedicineAgency For Toxics Substances and Disease RegistryMailstop: F-621600 Clifton Road, NEAtlanta, GA 30333

Re: Docket ATSDR-253: Supplemental Comment On DraftToxicological Profile For Perfluoroalkyls

Ms. Roney:

As a supplement to our October 30, 2009, November 3, 2009, January 21, 2010,September 19, 2011, January 17, 2012, February 6, 2012, April 20, 2012, August 14,2012, November 28, 2012, and January 9, 2013, comments on the referenced draffToxicological Profile For Perfluoroalkyls, we wish to include references to the followingadditional documents/data that we believe should be reviewed and considered beforefinalizing the current draft Profile:

Granurn, B., et ai., "Pre-natal exposure to perfluoroalkyl substances may beassociated with altered vaccine antibody levels and immune-related healthoutcomes in early childhood," J. Immunotoxicol., Early Online (doi:10.3109/1547691X.2012.755580){on-line Jan. 25, 2013); and

2. Vested. A., et al., "Associations of in Ufe/o Exposure to Perfluorinated Alkyl Acidswith Human Semen Quality and Reproductive Hormones in Adult Men," Environ.Health Perspec. (htti3:Ildx.doi.orci/1 0.1289/eh'.1205118) {on-line Jan. 28, 2013).

Although these materials became available after the October 30, 2009, public commentdeadline, we note that ATSDR has committed to consider "comments received after thepublic comment period" on "the basis of what is deemed to be in the best interest of thegeneral public." As these new materials relate to potential health risks to peopleexposed to perfluoroalkyls, we believe that consideration of these materials is in the

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Ms. Nickolette RoneyJanuary 30, 2013Page 2

best interest of the general public and that ATSDR should afford the information dueconsideration prior to any finalization of the current draft Profile. Thank you.

..---~cry'July yoal"),

--Robe& A. Bilott

RAB:mdmEnclosurescc: Elizabeth A. Doyle (USEPA)(w/encls.)

Joyce Donahue (USEPA)(w/encls.)

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JI:I

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CLASS ACTION SETTLEMENT AGREEMENT

This Class Action Settlement Agreement (the "Agreement" ) is entered into as of the 17th

day of November, 2004, by and among E. I. du Pont de Nemours and Company, a Delaware

corporation (the "Defendant" ), on the one hand, and Jack W. Leach, William Parish, Joseph K.Kige:, Darlene G. Kiger, Judy See, Rick See, Jack L. Cottrell, Virginia L. Cottrell, Came K.Allinan, Roger D. Allman, Sandy Cowan, and Aaron B.McConnell (the "Named Plaintiffs") onbehalf of themselves and the Class Members (as defined in Section 1.11below) on the otherhand. This Agreement memorializes the settlement among the Named Plaintiffs on behalf ofthemselves and the Class Members (as hereinafter defined) and the Defendant (collectively the"Settling Parties" ).

RECITALS

A. There is currently pending in the Circuit Court of Wood County, West Virginia(the "Court"), an action captioned Jack W. Leach. et al. v. E. I. du Pont de Nemours andCompany and Lubeck Public Service District, Case No. 01-C-608 (the "Lawsuit" ). The Lawsuithas been certified as a class action pursuant to an Order on Class Certification and RelatedMotions entered by the Court on April 10, 2002. The Court clarified the definition of the Classin an Order entered on June 26, 2003.

B. The Settling Parties wish to promptly and fully resolve and settle the differencesamong them with respect to the Lawsuit, on the terms and conditions set forth in this Agreement,which Class Counsel believe are fair, reasonable, adequate, and beneficial to and in the bestinterests of the Class Members.

C. The Amended Complaint filed in this Lawsuit included claims against the LubeckPublic Service District. Those claims have since been resolved in a settlement approved by theCourt in an order entered on April 22, 2003. Lubeck Public Service District is not a party to thisAgreeinent and is not in any way bound by the terms of the Settlement (as hereinafter defined).

NOW THEREFORE, in consideration of the mutual promises contained in thisAgreement, the parties hereto hereby agree as follows:

1. DEFINITIONS. Capitalized terms and phrases not otherwise defined in thisAgreement shall have the meanings set forth below.

10 hereof.1.1 "Administrator" shall mean the neutral administrator described in Article

hereof1.2 "Administrator Contract" shall have the meaning provided in Section 10.2

Agreement.1.3 "Agreement*'hall have the meaning provided in the Preamble of this

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2.1.1hereof.1.19 "Eligible Private Sources" shall have the meaning provided in Section

hereof.1.20 "Employee Study" shall have the meaning provided in Section 12.1

1 21 "Fairness Hearing" shall have the meaning provided in Section 2. l,.5.

1.22 'Fee Percentage" shall have the meaning provided in Article 8 hereof.

1.23 "Final" shall mean: with respect to any judicial ruling or order, that the

period for any petitions for appeals, appeals, petitions, writs, motions for rehearing or certiorarior any other motions required to seek review by any court with appellate or original jurisdictionhas expired without the initiation of a review proceeding, or, if a review proceeding has beentimely initiated, that there has occurred a full and final. disposition of ariy such reviewproceeding, including the exhaustion of proceedings in any remand and/or subseq'uent appeal onremand.

1.24 "Final Settlement Order" shall have the meaning provided in Section

1.25 "General Causation" shall mean that it is probable that exposure to C-8 is

capable of causing a particular Human Disease.

1 26 "Health Studies" shall incan the Employee Study, the Community Study,the "Hypothesis Testing Studies," all as more particularly defined in Article 12.

12.2.3hereof.1.27 "Hypothesis Testing Studies" shall have the meaning provided in Section

1.28 "Human Disease" shall mean a serious latent disease that results in aninterruption, cessation, or disorder of body functions, systems, or organs. The term "HumanDisease" as used herein includes birth defects.

hereof.1.29 "Initial Funding Level" shall have the meaning provided in Section 12.4.1

Agreement

1.30 "Itutial Released Claims" shall have the meaning provided in Section 3.2

1.31 "Lawsuit" shall have the meaning provided in Recital A of this

1.32 "Medical Monitoring" shall mean diagnostic medical examinations, testsor procedures utilized to detect Human Disease.

12.4 hereof.1.33 "Medical Monitoring Fund" shall have the meaning provided in Section

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1.34 "Medical Monitoring Protocol" shall have the meaning provided inSection 12.3.2hereof.

1.35 'Medical Panel" shall have the meaning provided in Section 12.3 hereof.

1.36 "Medical Panel Contracts" shall have the meaning provided in Section10.2.2(b)(l) hereof.

1.37 "Minimum Participation Level" shall have the meaning provided inSection 2 1.4hereof

L3Sthis Agreement.

"Named Plaintiffs" shall have the meaning provided in the Preamble to

1.39 "Non-Employee Opt Outs" shall mean those "Opt Outs" who are notcurrent or former employees of the Defendant.

1.40 "Notice of Clarification Regarding Class Member Status" shall mean theNotice of Clarification Regarding Class Meinber Status sent to certain current and formeremployees of the Defendant in accordance with the Agreed Order entered by the Court onAugust 16, 2004.

hereof.1.41 "No Association Finding" shall have the meaning provided in 12.2.3(a)(2)

1.42 "No Probable Link Finding" shall have the meaning provided in Section12.2.3(b)(2)hereof.

1.43 "Notice" shall have the meaning provided in Section 2.1.2hereof.

1.44 "Opt Out" shall refer to the process for individuals to exercise their rightto exclude themselves from the Certified Class in accordance with Rule 23(c)(2) of the WestVirginia Rules of Civil Procedure.

1.45 "Opt Outs" shall mean those individuals included in the Certified Classwho have exercised the right to Opt Out and thus are not Class Members.

2.1.2hereof.

1.46 "Phase I" shall have the meaning provided in Section 12.2.3(a)hereof.

1.47 "Phase II" shall have the meaning provided in Section 12.2.3(b)hereof.

1.48 "Preliminary Approval Order" shall have the meaning provided in Section

1.49 "Probable Link" shall mean that based upon the weight of the availablescientific evidence, it is more likely than not that there is a link between exposure to C-8 and aparticular Human Disease among Class Members.

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subsidiaries, insurers and counsel, and its or their predecessors, successors or assigns ("ReleasedParties" ).

3.2 Initial Release and Covenant Not to Sue. Effective upon the disbursementof the Settlement Amount pursuant to Section 9.1,the Named Plaintiffs, on their own behalf and

on behalf of the Class Members, release and forever discharge the Released Parties &om any and

all claims, losses, damages, attorneys'ees, costs, and expenses, whether asserted or not, accruedor not, known or unknown including, but not limited to, claims for medical monitoring, propertydamage (including claims based upon alleged diminution of value or stigma), injunctive reliefand special, general and punitive damages associated with such claims that: (a) are not covered

by the Conditional Release provided in Section 3.3;(b) relate to exposure to C-8 of ClassMembers from any and all pathways including, but not limited to, air, water and soil; and (c) arebased on the same factual predicate as raised in the Lawsuit (collectively, the "Initial ReleasedClaims" ). This release is intended to include the release of unknown ~d unsuspected claims, aswell as any claim or right obtained by assignment. This release is not i'ntendhd'o include therelease of any rights or duties created by or that could be created by this Agreement, including,but not limited to, the express warranties and covenants set forth herein. The Named Plaintiffs,on their own behalf and on behalf of the Class Members, further covenant and agree not to fileany action or proceedings against the Released Parties or their counsel based on the InitialReleased Clauns. Nothing in this Agreement releases any person other than the Released Parties.

3.3 Conditional Release and Covenant Not to Sue Effective upon theoccurrence of (a) the disbursement of the Settlement Amount pursuant to Section 9.1,and (b) theearlier of (i) the date on which the Science Panel delivers a No Association Finding with respectto a Human Disease to the Administrator as described in Section 12.2 3(a)(2) and (ii) the date onwhich the Science Panel delivers a No Probable Link Finding with respect to a Human Diseaseto the Administrator as described in Section 12,2.3(b)(2), the Named Plaintiffs on their ownbehalf and on behalf of the Class Members, release and forever discharge the Released PartiesRom any and all claims, losses, damages, attorneys'ees, costs, and expenses, whether assertedor not, accrued or not, known or unknown, for personal injury and wrongful death, including but

not limited to any claims for injunctive relief and special, general and punitive and any otherdamages whatsoever associated with such claims, that: (a) relate to exposure to C-8 of ClassMembers from any and all pathways including, but not limited to, air, water and soil; (b) arebased on the same factual predicate as raised in the Lawsuit; and (c) relate to any Human Diseasefor which the Science Panel has delivered a No Association Finding or No Probable LinkFinding to the Administrator as described in Section 12.2.3(collectively the "ConditionallyReleased Claims" ). This release is intended to include the release of unknown and unsuspectedclaims, as well as any claim or right obtained by assignment. This release is not intended toinclude the release of any rights or duties created by or that could be created by this Agreement,including, but not limited to, the express warranties and covenants set forth herein. The SettlingParties acknowledge and agree that the release of Conditionally Released Claims as provided in

this Section 3.3 may become effective, if at al 1, at different times'for different Human Disease(s),as the Science Panel'ompletes Phase I, and if necessary, Phase II of its work in accordancewith Section 12.2.3. The Named P taintiffs on their own behalf and on behalf of the ClassMembers further covenant and agree not to file any action or proceedings against the ReleasedParties based on the Conditionally Released Claims unless and until the Science Panel delivers aProbable Link Finding to the Administrator as described in Section 12 2.3(b)(1)with respect to

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the specific Human Disease at issue in the Conditionally Released Claim. In the event that theScience Panel delivers a Probable Link Finding to the Administrator as described in Section12.2.3(b)(1),the release of Conditionally Released Claims described in this Section 3.3 shall notbecome effective with respect only to those Conditionally Released Claims in which the specificHuman Disease(s) for which a Probable Link Finding has been delivered is/are at issue, Upondelivery of any Probable Link Finding to the Administrator, Defendant agrees that, in anypersonal injury or wrongful death action brought by, on behalf of, or otherwise pertaining to aClass Member, Defendant will not contest the issue of General Causation between C-8 and anyHuman Disease(s) as to which a Probable Link Finding has been delivered, but reserves the rightto contest Specific Causation and damages as to any individual Class Member or plaintiff and toassert any other defenses not barred by this Agreement. Nothing in this Agreement releases anyperson other than the Released Parties.

4. NO ADMISSION OF LIABILITY.

4.1 The Settling Parties understand and agree that this Agreement embodies acompromise settlement of disputed claims, and that nothing in this Agreement, including thefurnishing of consideration for this Agreement, shall be deemed to constitute any finding oradmission of wrongdoing by Defendant, or give rise to any inference of wrongdoing oradmission of wrongdoing or liability in this or any other proceeding. Moreover, Defendantspecifically denies any such liability or wrongdoing. Subject to the provisions set forth inSection 3.3 and Article 6 hereof with respect to the tolling and potential preservation of theConditionally Released Claims and the findings of the Science Panel, Defendant states that it isentering into this Settlement to avoid the time, expense and distraction of embroilment in thecurrent Lawsuit and potential future litigation and disputes relating to present, past or future C-8exposure claimed to be attributable to the operations of Washington Works.

4.2 Any agreement, stipulation and/or the Court's Preliminary Approval Orderrelated to the definition of the Certified Class in accordance with Section 2.1.1shall notconstitute and shall not be construed as an admission on the part ofany Released Party that thisaction (in the event that this Agreement is terminated under the conditions described in Article7), or any other proposed or certified class action is appropriate for class treatment pursuant toW'est Virginia Rule of Civil Procedure 23 or any other class action statute or rule, and does notconstitute a waiver of any substantive or procedural defenses. This Agreement is without

prejudice to the rights of Released Parties (a) in the event that this Agreement is terminatedunder the conditions described in Article 7, to seek decertification or modification of the trialclass as certified in the Court's Order of April 10, 2002, as clarified by the Court's Order of June

26, 2003, or (b) to oppose certification in any other proposed or certified class action.

4.3 Neither the terms, nor the existence of this Agreement shall be admissiblein any other proceeding, except for proceedings brought by, on behalf of, or pertaining to ClassMembers for (a) alleged breach of this Agreement or (b) Conditionally Released Claims forwhich the release does not become effective as provided in Section 3.3.

4.4 Defendant's agreement not to contest General Causation for Human

Disease(s) for which the Science Panel has delivered a Probable Link Finding to theAdministrator in any personal injury or wrongful death action brought by, on behalf of, or

10

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January 8, 2009

Provisional Health Advisories forPerfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS)

l. Introduction

EPA recently concluded limited testing of agricultural sites in Alabama where sewagesludge was applied from a local wastewater treatment plant that receives wastewater fromnumerous industrial sources, including facilities that manufacture and useperfluorooctanoic acid (PFOA) and other perfluorinated chemicals (PFCs). The resultsfrom this limited testing indicated elevated levels of PFCs in the sludge and the soil thatreceived the sludge. As a result, EPA has conducted sampling of public drinking water.The levels of PFOA and perfluorooctane sulfonate (PFOS) recently analyzed incommunity water systems in Lawrence and Morgan Counties are all lower than 0.04 ppb.Based on its current understanding, EPA believes these levels are not of concern andresidents may rely upon public water systems. EPA will soon begin groundwater andsurface water sampling to determine if PFOA or PFOS has migrated into any privatedrinking water supplies and ponds in the affected area.

The Office of Water (OW) has developed Provisional Health Advisory values'or PFOAand PFOS to assess potential risk from exposure to these chemicals through drinkingwater. Other PFCs have been found at this site. However, information on the toxicity ofPFCs other than PFOS and PFOA is limited and therefore no attempt is made at thepresent time to develop Provisional Health Advisory values for these other PFCs.

2. Summary of Data for PFOA

Epidemiological studies of exposure to PFOA and adverse health outcomes in humansare inconclusive at present.

Several animal toxicological studies have been conducted using PFOA. These includesubchronic, developmentaVreproductive, and chronic toxicity/carcinogenicity studies inseveral animal species, in both sexes. An evaluation of these studies was conducted bythe European Food Safety Authority (EFSA) and no-observed-adverse-effect level(NOAEL), lowest-observed-adverse-effect level (LOAEL), and critical endpointsidentified (EFSA, 2008).

Among these studies, a recent and well conducted developmental toxicity study in micewas selected by the Office of Water (OW) as the critical study for the derivation of the

I Provisional Health Advisory values are developed to provide information in response to an urgent orrapidly developing situation. They reflect reasonable, health-based hazard concentrations above whichaction should be taken to reduce exposure to unregulated contaminants in drinking water. They will beupdated as additional information becomes available and can be evaluated.

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Provisional Health Advisory for PFOA (Lau et al., 2006). In this study, CD-1 mice weregiven the ammonium salt of PFOA by oral gavage from gestational day (GD) 1 to 17 atdoses of 0, 1, 3, 5, 10, 20 or 40 mg/kg/day. Significant increase in the incidence of full-litter resorption occurred at 5 mg/kg/day and higher doses. Weight gain in dams thatcarried pregnancy to term was significantly lower in the 20-mg/kg/day group. At GD 18,some dams were sacrificed for maternal and fetal examinations (group A), and the restwere treated once more with PFOA and allowed to give birth (group B).Postnatalsurvival, growth, and development of the offspring were monitored. PFOA inducedenlarged liver in group A dams at all dosages, but did not alter the number ofimplantations. The percent of live fetuses was lower only in the 20-mg/kg/day group (74vs. 94% in controls), and fetal weight was also significantly lower in this group.However, no significant increase in malformations was noted in any treatment group. Theincidence of live birth in group B mice was significantly lowered by PFOA: ca. 70% forthe 10- and 20-mg/kg/day groups compared to 96% for controls. Postnatal survival wasseverely compromised at 10 or 20 mg/kg/day, and moderately so at 5 mg/kg/day. Dose-dependent growth deficits were detected in all PFOA-treated litters except the 1-mg/kg/day group. Significant delays in eye-opening (up to 2—3 days) were noted at 5mg/kg/day and higher dosages. Accelerated sexual maturation was observed in maleoffspring, but not in females. These data indicate maternal and developmental toxicity ofPFOA in the mouse, leading to early pregnancy loss, compromised postnatal survival,delays in general growth and development, and sex-specific alterations in pubertalmaturation (Lau et al., 2006).

Toxicity endpoints identified in the Lau et al. (2006) study included a number ofdevelopmental landmarks: neonatal eye opening, neonatal survival and body weight atweaning, reduced phalangeal ossification at term, live fetus weight at term, maternal liverweight at term, and maternal weight gains during pregnancy. The most sensitiveendpoint was for increased maternal liver weight at term. This endpoint for liver effectswas identified in a number of other studies described in EFSA (2008).

Benchmark dose (BMDip) and the 95% lower bound on the BMD (BMDLip) werecalculated for these toxicity endpoints by the EFSA on the basis of raw data provided bythe principal author (Lau, personal communication, November 18, 2008). The lowestBMDLip in the Lau et al. (2006) study was 0.46 mg/kg/day for increase in maternal liverweight at teil. This value was used as the point of departure for the derivation of theProvisional Health Advisory value for PFOA. It should be noted that liver effects werealso reported in studies in rats and monkeys. BMDLip values for increased liver weightin studies in mice and rats ranged from 0.29 to 0.74 mg/kg/day (EFSA, 2008). TheBMDLip for Lau et al. (2006) was in the middle of this range.

3. Summary of Data for PFOS

Epidemiological studies of exposure to PFOS and adverse health outcomes in humans areinconclusive at present.

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Several animal toxicological studies have been conducted with PFOS. These includesubchronic, developmentaVreproductive, and chronic toxicity/carcinogenicity studies inseveral animal species, in both sexes. An evaluation of these studies was conducted bythe EFSA (2008) and NOAEL, LOAEL and critical endpoints identified.

The subchronic toxicity study in Cynomolgus monkeys (Seacat et al., 2002) was selectedby the OW as the critical study for the derivation of the Provisional Health Advisoryvalue for PFOS. In the study by Seacat et al. (2002), groups of male and female monkeysreceived orally potassium PFOS at doses of 0, 0.03, 0.15 or 0.75 mg/kg/day for 183 days.Compound-related mortality in 2 of 6 male monkeys, decreased body weights, increasedliver weights, lowered serum total cholesterol, lowered triiodothyronine (T3)concentration, and lowered estradiol levels were seen at the highest dose tested. At 0.15mg/kg/day, increased levels of thyroid-stimulating hormone (TSH) in males, reducedtotal T3 levels in males and females, and reduced levels of high-density lipoproteins(HDL) in females were seen. A NOAEL of 0.03 mg/kg/day was identified in this study.

4. Calculation of Provisional Health Advisories for PFOA and PFOS

The general equation for the derivation of a Provisional Health Advisory is:

(NOAEL or BMDL&p) x BW x RSCUF x Extrapolation Factor x Water intake

Where BW = body weight; RSC = relative source contribution; UF = uncertainty factors

The OW is using the exposure scenario of a 10-kg child consuming 1 L/day of drinkingwater to calculate the Provisional Health Advisories for PFOA and PFOS. Thispopulation subgroup was used because children, who consume more drinking water on abody weight basis than adults, have a higher exposure on a body weight basis than adults.The selection of children's exposure parameters will help to ensure that this ProvisionalHealth Advisory is protective of sensitive populations potentially exposed. A defaultrelative source contribution (RSC) of 20% was used to allow for exposure from othersources such as food, dust and soil. The relevant period of exposure for the HealthAdvisory is a short-term exposure. This time period is consistent with the toxicity dataused for PFOA and PFOS, both of which rely upon subchronic data, The value should beprotective of all population subgroup and lifestages.

Data derived extrapolation factors for toxicokinetics were developed to betterapproximate internal doses for PFOA and PFOS. This step was deemed importantbecause of the marked differences in retention time among humans and the test species inwhich toxicological data were collected. Available data for PFOA from female miceindicate a half-life of 17 days and from humans, a half-life of 3.8 years (1387 days).Critically, measures of internal exposure should be used as the basis for interspeciesextrapolation; the assessment is somewhat complicated by the lack of area under thecurve (AUC) or clearance (CL) data. However, the one-compartment model foundation

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is useful to convert half-life data to clearance data, assuming steady-state has beenreached (Equation 1).

Half-life = (ln 2 or 0.693) x Volume of Distribution / CL (1)

The volume of distribution of 198 + 69 ml/kg has been estimated in female monkeys(Butenhoff et al., 2004). Olsen et al. (2007) summarized other findings on PFOS andPFOA as indicating primarily an extracellular distribution volume. Olsen et al. (2007)also cited other reports that these agents were highly bound to plasma proteins in rats,monkeys and humans. Together, these data support using the same volume ofdistribution for rodents and humans, based on the findings (198 ml/kg) in monkeys.

The mouse half-life of 17 days converts:CL = (0.693 x 198 ml/kg) / 17 days = 8.07 mVkg/day

The human half-life of 1387 days converts:CL = (0.693 x 198 ml/kg) / 1387 days = 0.10mVkg/day

Calculating the toxicokinetic portion of the interspecies on the basis of plasma CL wouldbe:

CL animal / CL human = 8.07 ml/kg/day / 0.10ml/kg/day = 80.7

The total interspecies correction derived from using a 3X for toxicodynamics and 81X fortoxicokinetics is 243X.

To calculate the Provisional Health Advisory for PFOA, a default intraspecies uncertaintyfactor of 10 was applied to the BMDL&p of 0.46 mg/kg/day to account for variation insusceptibility within the human population. A default uncertainty factor of 3 was usedfor toxicodynamic differences between animals and humans.

The following Provisional Health Advisory is obtained:

PFOA Provisional Health Advisory = 0.46 x 1000 x 10 x 0.2 = 0.4 pg/L10x3 x 81 x 1

Similarly, a data-derived extrapolation factor was developed for PFOS. The half-lives ofPFOS in humans and in male and female monkeys were estimated by Lau et al., (2007) tobe 5.4 years and 150 days, respectively.

The monkey half-life of 150 days converts:CL = (0.693 x 198 ml/kg) / 150 days = 0.915mVkg/day

The human half-life of 1971 days converts:CL = (0.693 x 198 ml/kg) / 1971 days = 0.07 ml/kg/day

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Calculating the toxicokinetic portion of the interspecies on the basis of plasma clearancewould be:

CL animal / CL human = 0.915ml/kg/day / 0.07 ml/kg/day = 13.1

The total interspecies correction derived from using a 3X for toxicodynamics and 13X fortoxicokinetics is 39X.

To calculate the Provisional Health Advisory for PFOS, a default intraspecies uncertaintyfactor of 10 was applied to the NOAEL of 0.03 mg/kg/day to account for variation insusceptibility within the human population. A default uncertainty factor of 3 was used fortoxicodynamic differences between animals and humans.

The following value is obtained:

PFOS Provisional Health Advisory = 0.03 x 1000 x 10 x 0.2 = 0.2 pg/L10x3 x 13 x 1

REFERENCES

Butenhoff JL, Kennedy GL Jr, Hinderliter PM et al. (2004). Pharmacokinetics ofperfluorooctanoate in cynomolgus monkeys. Toxicol Sci. 82:394-406.

EFSA (2008) European Food Safety Authority. Opinion of the Scientific Panel onContaminants in the Food Chain on Perfluorooctane sulfonate (PFOS) andPerfluorooctanoic acid (PFOA) and their Salts. EFSA Journal, 2008, Journal number653, 1-131;available at http: //www.efsa.europa.eu/EFSA/efsa locale-1178620753812 1211902012410.htm).

Lau C, Thibodeaux JR, Hanson RG et al. (2006). Effects of perfluorooctanoic acidexposure during pregnancy in the mouse. Toxicol. Sci. 90 (2) 510-518.

Lau C, Anitole K, Hodes C et al. (2007). Perfluoroalkyl acids: A review of monitoringand toxicological findings. Toxicol. Sci. 99 (2) 366-394.

Olsen GW, Burris JM, Ehresman DJ et al. (2007). Half-life of serum elimination ofperfluorooctanesulfonate, perfluorohexanesulfonate, and perfluorooctanoate in retiredfluorochemical production workers. Environ Health Perspect. 115: 1298—1305.

Seacat AM, Thomford PJ, Hansen KJ et al. (2002). Subchronic toxicity studies onperfluorooctanesulfonate potassium salt in Cynomolgus monkeys. Toxicol. Sci. 68, 249-264.

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:I

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IV ~RESEARCH

3058 Research Orive

State Collage, Pennsylvania 16801 USA

Telephone: 814.272.l039

Fax: 814.272.1019

Report ofAnalysis

Fluorochemical Characterization of Aqueous Samples

Project Name: P0005113

MPl Research Laboratory Report No. L0018925, L0018927, L0018958,

L0019129

Initial Report Date: 11/10/09

Revision Report Date: 11/23/09

Testing Laboratory

MPt Research, Inc.3058 Research Drive

State College, PA 16801

Requester

Blair D. Burgess, Jr.AECOM Inc.

2809 West Mall DriveFlorence, AL 35630

Phone: 256-740-2382

PAGE1 OF5

Page 50: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

IV~RESEARCH

3058 Research Drive

State College, Pennsyivanla 16801 USA

Telephone: 814.272.1039

Fax: 814.272.1019 Analytical Report

Sufnmary of Fluorochemical Residues in Water Samples by LC/h6/MS

Sample ID

Sample ¹1 Horton Springs

Sample ¹1 Duplicate Horton Springs

Sample ¹2 Lawson fk Newby Wells

Sampie ¹2 Lawson B Newby Wells Duplfcate

Sample ¹3 Swan Creek Community Well

Sample ¹3 Swan Creek Communfty Well Duplkate

Trfp Blank

Finished Water Sample 1

Finished Water Sample 1 Duplicate

Trip Blank

WTP Sample 1

WTP Sample 1 Duplicate

Sinking Creek Sample 1

Stnking Creek Sample 1 Duplicate

Turkey Creek Sample 2

Turkey Creek Sample 2 Duplkate

Trip Blank

PFOA

Porfluorooctanok Add

Analyte

Found

(ng/mL)

& 0.025'~

0.025'4

& 0.025'.025"

0.025'"

& 0.025'

0.025 n

0 025"& 0.025 '

0.025'.

0317'.02e2'"

~ 0.025"«0.025 '

0.010

& 0.010& 0.025

PFOS

Pertfuor octanosulfonate

Analyte

Found

(ng/mL)

& 0.010'

0.010

& 0.010'

0.010'

0.010'

0.010'

0.0100.0102'

0.010

& 0.0100.0208'

0.0155'.0110'

0.010

& 0.025k n

& 0 025"'

0.010

FOSA

Porfluor otanasufphonamide

Analyte

Found

(ng/mL}

& 0.010'

0.010

& 0.010'

0.010'

0.010'

0.010'

0.010& 0.010'

0.010'

0.010& 0,010'

0.010'

0.010

& 0.010'

0.010'

O.ON'

0.010

'he second and third injections of the LLOQ CCY standard {0.005ng/mL) were outstde the acceptance

criteria of 70-130K, but were disregarded because the LLOQ calibration standard was excluded from the

calibration curve (see Note 2}.

The lowest calibratfon standard (0.005 ng/mL) was excluded from the calculation of the calibration curve

because the average peak area of the method blanks was greater than 50% of the standartfs peak area,

resuiting in an increased LOQ,

'he High Field Matrix recovery was outside the QC acceptance criteria of 50-150%. The Low Ffeld Matrfx recovery was within

the acceptance criteria of 50-150% and the spikfng concentration is within the Exhibit C criteria of 0.5 to 10 ttmes

endogenous sample levels, this data is considered reportable.

'he High and Low Field Matrix Spike recovery were outside the QC acceptance criteria of 50-150K, therefore the

data is considered not reportable.

'The low Field Matrix spike recovery was outside the acceptance criteria of 70-13os.

'his individual sample was prepared and run again on 10/12/2009 after being reanalyzed for PFOS on

10/09/2009 because ft was inadvertently skipped during the addition of internal standard to the samples.

'Outside the QC acceptance criteria of &20% relathe percent difference (RPD) of duplicate samples

'he High Field Matrix Spike recovery was outside the acceptance criteria of 70-t 30S.

Page 51: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

AECOIN

1360 s-oevsrirra Shel NE, Spec 500ASaran. Georgia 80KB

Facsimile

To

Fax

Page - 1

Tracey HaI

November 24, 200S

With everyone isravaltabls because of the hoIdays, I wNl have ta watt unI Monday ta deHvsr thefull MPl lab report I have attached the sfsTfmafy page of the municipal sample r '. None ofthe resuls far PFOA and PFOS wenp above the PHA. Below is the correlation between samplesand utiNy cam pany.

~ Decatur UtiQiee (Ffnished ~Sample 1);~ Umestone County Water and Sewer Authaf1ty (Sample 41 Harlan Springs and Samptff If2

Lawson S Newby Wels);~ Swan Creek Carnmiailty (Sampler C3 Swan Creek CorrITafnity);~ City af Moult!0n (Sinking Creek Sample 1 and Turkey Creek Sample 2); and~ West Morgan - East Lawrence Water Authority (WTP Sampte1).

Please let me knaw if you need anything before Monday, feel free la give me a.catt (4044B5-9695).

Tracey Mall

tracey. hallaecom.corn

To wawae arxf arrernin pre aorlrn fnnk, nnklral sxl norse enlewrrmw

This fir is ~ ~.~~crarrnarragHan ~, ~ for Ire~er ener nernerf ebrnre. p ee rerafer ef fhie ir~ ia rnxihe infanded ear!kienf. pfaaare riafefa end nao eras rs~nkresnir, rsakknsion, a cnprins or ciarxnra~Thank You.Onralaas2

Page 52: 2013 - Green Science Policy Institute · Serum Sampling In the Vicinity of Decatur, Alabama — Morgan, Lawrence, and Limestone Counties (ATSDR, April 1, 2013) Dear Dr. Tierney: We

Vi:~'%5bbeseartb Drie

Shh Oolsye, hwnsyhwds IOSN IISA

Toesborsc Ni22Z. 1055

yac ffr AXPLIN5 Analytical Report

~v5upplq~Cchl 5

Seeps N llorlaa Springsl~ b~ Swnrde dt Oopihute Itcston

seraph pt Loosen h Ihwby woth

Sea@le Alt Lawsen 4 Ihwby Ways Outdkate

Swnpte PS Swen CraakC "y Wey

Swnple 03 Swan Creak Cowununhy Well OupUcatoCrees

Q5c~Y ybdrbsd Wsaar Saerpbr 1

i+5, Rrddwd War Senode I QupMcste

Trip Qenk

T ~ts / ~ VyfP Swnple 1

Qnkhg Creek Samphr 1~md.re.I

Stnkhy Cnreb Sarnpie I Oupthste

Turkey Creek Sarrade 2

pnelyae

(nylrnL)

.4OZS'"

~ OAIISre

~ 40ISre

«OAQ5m

«40IS

«OASIS~

40IS&« ILOSS«A

«OAIIS

OAQIV'A

O.CIST.4m''

«0.010

«O.NO

«4OISP

Seudyte

yoswd

OsyrseL)

«4010

«0,010

«4010'4NO'4NO

«4010O.OIOZ

«ILNO'O.NO

O.ytoy

OAI155

0.0110'

IL010

« ILIKI

«0.010

y —,

«O.ytty

«0.010'O.NO'0.010'O.NO'0.&'4NO

«O.NO'0.010'

0.010«

ILNO'0.010'OAIIO'O.NO

«OPN'O.NO'0.0'10

'The uicond and thbd%$ ectkess of the LLOO CCV ktandanl f405 eNrreLI wwa snaskh the ~~crhwse of 70-150S, but were~~ been«re the ILOII~stendanl uws euctoded from thecaldaatim erose Isee Note 14

'he lowest calhaatkm standenf OLOOS eyrsnLI wso — fram the ~r of the ~~r steve

because tl»~peak ~of Ihe seethed btaaks was praeter than 505 ef ore atandenfu peek «ee.reeutthy ln en ausasaed LOLL

«The Ihgh phbt Itso1x ractnory was oatsid» the tie == —.=—- criteria of 50-15tsL Tbe Lew yteld ttsertu race«ery wws wtttdn

the acceptenm sraarh of 50150S end Ihe rpydny crau ~ IS whhln tae Exbtra C crkorh of tl5 to 10 tonessesatde h«ala, tbh data 1c--~-~~,

'be Iyyh and Low yhld )herbs splaetaceuury were ewndde the w aocepcwwa crkerh ef 50-1500, barefoot the

data Is r««~«d nst «r«

'Ttds ldsubhtsl sernple-wes prepared end rses ayah on Ior tsystop ~tudeg saalyesd ter pyos on

Io/Oe/2000 because lt was bsecheramtly yapped archy tbe eddkha ef internet standard to the swntees.

'Outskie the QC «ceptwrce crtterh of «205 retuthe percent dffferonce OIPPI of optimate scruples

s The llama ybed tssertu sfutw uccnrery arm oowsde tbe accspace crherh of 70 130t,