ROBERT A. BILOTT 859.547.4306 Taft/ 1717 Dixie Highway, Suite 910 Covington, Kentucky 41011?4704 Tel: 859.331.2838 Fax: 513.381.6613 December 13, 2017 BY EMAIL AND REGULAR U.S. MAIL Dr. Patrick Breysse Director of Office of the Director National Center for Environmental Health/Agency for Toxic Substances and Disease Registry 4770 Buford Highway NE, Mailstop F61 Atlanta, GA 30341 Dr. Pamela Protzel Berman Associate Director for Policy Office of the Director National Center for Environmental Health/Agency for Toxic Substances and Disease Registry 4770 Buford Highway NE, Mailstop F61 Atlanta, GA 30341 Ms. Kimberly Dills Congressional Affairs Team Lead Office of the Director National Center for Environmental Health/Agency for Toxic Substances and Disease Registry 4770 Buford Highway NE, Mailstop F61 Atlanta, GA 30341 Taft Stettinius Hollister LLP Dr. Rachel Worley Environmental Health Scientist Division of Community Health lnves?ga?ons Agency for Toxic Substances and Disease Registry 4770 Buford Highway NE, Mailstop F59 Atlanta, GA 30341 Ms. Felicia Suite Assistant Director for Policy Division of Toxicology and Human Health Sciences Agency for Toxic Substances and Disease Registry 4770 Buford Highway NE, Mailstop 57 Atlanta, GA 30341 Ms. Debora Tress Senior Attorney Office of the General Counsel Centers for Disease Control and Prevention 1600 Clifton Rd., NE, Mailstop D53 Atlanta, GA 30329 Chicago Cincinnati Cleveland/ Columbus/ Dayton lndianapolis/ Northern Kentucky] Phoenix December 13, 2017 Page 2 Ms. Kerry Caudwell Associate Director for Policy and Strategy Division of Community Health Investigations Agency for Toxic Substances and Disease Registry 4770 Buford Highway NE Mailstop F59 Atlanta, GA 30341 Re: Request for Coordinated Nationwide PFAS health Studies and Testing Ladies and Gentlemen: Thank you for speaking with me in connection with the referenced matter during our conference call on November 20, 2017. As we discussed, our firm had sent letters to your Agencies on September 5, 2017, (extra copies of text attached), asking for immediate implementation of nationwide, coordinated, comprehensive studies and/or investigations of the impacts to human health from the presence of PFAS in drinking water across the country and among fire fighters and other emergency responders exposed to PFAS through either firefighting foams or their gear. As noted in those original letters, we believe your Agencies could build upon the work done through the C8 Health Project, C8 Science Panel, and C8 Medical Panel arising from our settlement of legal claims relating to PFOA, and expand those models to investigations, studies, and testing for the broader range of PFAS exposures. Based upon our call, and Director Breysse?s letter of November 6, 2017' (attached), we understand that ATSDR shares our concerns with respect to this important public health issue and has taken steps to begin discussing the issues with other federal agencies. On December 4, 2017', US EPA also announced that it plans to try to participate in coordinated activities among various federal agencies with respect to PFAS exposures. (See attached.) To date, however, we are unaware of any nationwide studies of the nature we requested being actually initiated by any such federal agencies. We understand that funding historically has been perceived to be an impediment to initiating such work. Yet, we now understand that, under the National Defense Authorization Act for Fiscal Year 2018 that the President signed yesterday, Congress has now made at least $7 Million available for CDC and ATSDR to ?commence a study on the human health implications of per- and polyfluoroalkyl substances (PFAS) contamination in drinking water and any other sources of water and relevant exposure pathways,? which must include an ?exposure assessment? that includes ?no less than 8 current or former domestic military installations known to have PFAS contamination in drinking water, ground water, and any other sources of water and relevant exposure pathways.? Please confirm whether this means that your Agencies will now move forward immediately with the types of studies we requested (without the December 13, 2017 Page 3 need for formal legal action to force such work), and the schedule by which such work will be conducted. As for the type of study and testing of firefighters and emergency responders we requested, please confirm whether your Agencies understand this new legislation and funding to include such work. We understand from our November 20 conference call that ATSDR may have been interpreting the work we were requesting in this regard to be something that had to be handled and coordinated through Please confirm whether that remains the case or whether firefighter and emergency responder exposures can be incorporated within the scope of any new PFAS work by your Agencies. Also, as we discussed during our November 20 conference call, we continue to seek to work with your Agencies and to participate as fully as possible in the design and implementation of any PFAS studies and/or testing. Please let us know if and when any such activities are planned and the manner and extent to which we can assist and/or participate. Our clients, Dr. Brooks and Mr. Hermes, remain available to meet with and assist in this regard. Finally, we understand from our November 20 conference call that ATSDR may be in the process of updating and revising its Toxicological Profile for the current version of which was last released several years ago. Please let us know when that material will be available and released to the public for review and comment. Thank YOU. Sincerely yours,? . 1 4' if," if . in?IV' Robert A. Bilott Attachs. cc: Dr. Paul Brooks (w/attachs) Mr. John Jeffrey Hermes (w/attachs) Taft/ 1717 Dixie Highway, Suite 910/ Covington, Kentucky 41011-4704 Tel: 859.331 .2838/Fax: 513 381.6513 ROBERT A. BILOTT 859.547.4306 bilott@tafllaw.c0m September 5, 2017' CERTIFIED MAIL RETURN RECEIPT REQUESTED Brenda Fitzgerald, M.D. Scott Pruitt Director - Administrator Centers for Disease Control and Prevention Administrator, Agency for Toxic Substances and Disease Registry US. Department of Health Human Services 1600 Clifton Road Atlanta, GA 30329-4027 Patrick Breyese, Director Agency for Toxic Substances and Disease Registry United States Environmental Protection Agency William Jefferson Clinton Building 1200 Ave., N.W. Mail Code: 1101A Washington, DC 20460 Jeff Sessions, Esq. United States Attorney General United States Department of Justice 950 Ave, N.W. Center for Disease Control 200 Independence Ave, SW. Washington, DC 20201 Washington, DC 20530-0001 Re: Request for Coordinated Nationwide PFAS Health Study and Testing and Notice of Intent to Sue Ladies and Gentlemen: For many years, unusually high rates of cancer and other adverse health effects have been observed among our nation?s fire ?ghters and emergency responders (collectively ?Responders?), particularly among Responders who handle or use firefighting foams made with highly fluorinated chemicals (per? and polyfluoralkyl substances, including PFOA and PFOS) collectively referred to as or wear gear Taft Stettlnius 8: Hollister LLP Chicago I Cincinnati Cleveland Columbus Dayton Indianapolis 1 Northern Kentucky! Phoenix September 5, 2017 Page 2 treated or made with such PFAS materials (collectively Equipment?). EPA acknowledged the risks posed by the entire family of In its "Long?Chain Perfluorinated Chemicals (PFCs) Action Plan which was released over seven years ago, but has never been fully implemented. (See Ex. A (excerpts).) EPA has, however, recently confirmed that at least one poses sufficient' ?potential adverse effects for the environment and human health based on its toxicity, mobility, and bioaccumulation potential? to support investigating and addressing its presence under the federal Superfund law codified in the Comprehensive Environmental Response and Liability Act of 1980, as amended, 42 U.S.C. 9601'et seq. (See Ex. (excerpts) at 9.) Through the authority granted to ATSDR under that same Superfund law, ATSDR has classified PFAS as a class ?of chemicals that meet the definition of ?toxic sI'Jbstance" within the scope of purview.1 Consequently, ATSDR has developed a draft toxicological profile for PFAS, issued various statements and guidance to impacted individuals and physicians dealing with certain PFAS exposures, and even agreed to partner with a handful of state or local entities investigating specific instances of specific types of PFAS contamination in specific communities. (See Ex. C.) To date, however, ATSDR has not embarked on any coordinated, comprehensive nationwide study or investigation of the impacts on the health of Responders from their use and exposure to PFAS Equipment, or associated testing of_ all such impacted individuals. We write to request that ATSDR move fonNard immediately with such a national study and testing. As explained below, ATSDR has the clear power and authority to mandate a national study of PFAS health impacts and associated testing among Responders exposed to PFAS Equipment, has access to mechanisms to secure funding from responsible parties, and has a proven model to follow to implement such a study/testing. Based on our past decade of experience designing and overseeing a project to assess human health impacts from one such PFAS PFOA we stand ready to assist ATSDR in overseeing the design and implementation of a nationwide study and testing focusing on Responder exposure to the entire class of PFAS chemicals through a program that could encompass and involve all affected parties, including manufacturers, impacted Responders and affected governmental entities/contractors and regulators, in a way that provides everyone with independent, credible scienti?c answers and certainty. l. ATSDR Has The Authority To Require A National PFAS Health Study and Testing And Ability To Secure Full Funding For Such Work. Under Section 104 of CERCLA, ATSDR shall ?provide medical care and testing to exposed individuals, including but not limited to tissue sampling, chromosomal testing where appropriate, epidemiological studies, or any other assistance appropriate under the circumstances? in situations involving ?public health emergencies caused or believed to be caused by exposure to toxicsubstances." (42 U.S.C. 1 See also 42 use :5 9604(i)(18). September 5,2017 Page 3 This is a non~discretionary mandate. Thus, under this provision of CERCLA, ATSDR (which, as noted above, already has classified PFAS asa ?toxic substance?) is not only authorized to conduct epidemiological studies and testing in circumstances where there have been excessive PFAS exposures, but is required to do so. EPA repeatedly has indicated that situations involving excessive levels of PFAS exposure qualify as public health emergencies mandating cessation of such exposures; For example, as early as 2002, EPA entered a consent order in which it found that levels of a PFAS (PFOA) exceeding the non-regulatory threshold used by EPA at that time presented a sufficient threat of ?imminent and substantial endangerment? to warrant the provision soon as practicable? of alternative drinking water to those exposed. (See Ex. (excerpts).) EPA entered similar orders noting the threat of such ?imminent and substantial endangerment? from excessive PFAS levels in drinking water, mandating immediatealternate drinking water supplies, after EPA adopted its first provisional health advisory guidelines for short-term exposures to two different PFAS materials (PFOA and PFOS) in 2009. (See Ex. reaffirmed this position as recently as January 2017 when it modified one of?those same consent orders to require immediate _clean water if levels of PFAS exceeded new long term health advisory level of no more than 0.07 for individual or ?combined levels of PFOA and PFOS. (See Ex. F.) EPA noted that these new, lower PFAS drinking water guidelines were based on review of "the best available peer-reviewed studies? indicating that exposure to these PFAS "may result in adverse health effects, including developmental effects to fetuses during pregnancy or to breastfed infants low birth weight, accelerated puberty, skeletal variations), cancer testicular, kidney) liver effects tissue effects antibody production and immunity), thyroid. effects and other effects cholesterol changes)? (Ex. G.) actions to date confirm its recognition that studying PFAS contamination issues falls squarely within its broad authority. As recently as May 23 of this year, ATSDR released the results of its own assessment of whether an 7 epidemiological study by the Agency of those exposed to PFAS contamination would be feasible. (Ex. (excerpts).) ATSDR confirmed in the context of evaluating the feasibility of studying adverse health effects among the adults, children, and military personnel exposed to multiple PFAS compounds in drinking water at the Pease international Tradeport that undertaking such a study could generate important ?scientific knowledge about the health effects of PFAS exposures? in particular, PFOS and exposures," if the study could be designed to encompass a sufficiently large population of impacted people. (Id. at 2.) In order to properly and thoroughly study certain types of less common diseases (including cancer) associated with these PFAS exposures, ATSDR acknowledged that there would need to be far more than the couple hundred or even couple thousand anticipated study participants at that one site, which might be feasible if a much larger number of individuals was incorporated into the study. (Id. at 43.) September 5, 2017 Page 4 II. A Proven Model EXists For Developing A National PFAS Health Study. Settlement of a prior class action lawsuit in which we represented the plaintiff class resulted in the creation of an independent scientific panel that studied the effects of PFOA?contaminated drinking water among a class of approximately 70,000 people whose drinking water supplies in West Virginia and Ohio had. been contaminated with quantifiable levels of the chemical (0.05 at the time) attributable to releases. from the Washington Works manufacturing plant then?owned by E. l. du Pont de Nemours Company (?DuPont?). Through an innovative settlement with DuPont in that case (known as the ?Leach Case"), we were able to secure sufficient funds to pay for: 1) blood testing of approximately 69,000 people through a ?08 Health Project?; 2) creation of a new ?08 Science Panel? of independent, world?class epidemiologists charged with confirming which diseases were linked to PFOA exposu're among the class being studied; 3) the design and implementation by the 08 Science Panel of approximately a dozen extensive epidemiological studies and retrospective exposure modeling work, including Class-wide studies of the exposed population; 4) provisions for immediate and long?term clean water/water filtration; and 5) medical monitoring/testing for all class members for each disease linked to their PFOA exposure. (See and Through . that settlement, we also were able to secure a binding agreement up front on how the results of the independent scientific work would be used in connection with future injury and compensation claims among the Leach Case class members, including the extent to which the independent scientific work would conclusively resolve issues of general causation as between the PFAS chemical at issue and the class member exposures. The settlement also included an agreement that all active litigation among the parties would be stayed and future ?lings barred (yet with all claims preserved and statutes of limitations tolled), pending the final outcome of the agreed scientific process. The work of the (38 Science Panel (and the related 08 Health Project) under this prior class settlement involved only one PFAS compound (PFOA) and only one responsible party (DuPont). There is no reason, however, why this same model cannot be expanded to the current situation facing Responders across the United States involving one or more (or a combination of) the other PFAS compounds in PFAS Equipment, potentially attributable to the actions of multiple responsible parties. Infect, expanding the model to include multiple responsible parties and regulators provides the . opportunity for creating a much bigger pool of funds and the opportunity to spread costs among a-much bigger and more diverse group. Likewise, addressing the issue within the context of a national class provides the opportunity for the responsible parties to fashion common, global remedies that allow for uniform, consistent relief and treatment of impacted parties and greater financial, scientific, and regulatory certainty. ATSDR already has acknowledged the significance and utility of the 08 Science Panel/CB Health Project model and work for addressing health issues related to PFAS exposures. As noted by ATSDR in its May 23, 2017, draft feasibility assessment for September 5, 2017 Page 5 studies at the Pease International Tradeport, the C8 Science Panel?s/08 Health Project?s work, which focused on human impacts from PFOA contamination, allows ATSDR to focus future PFAS studies on the effects from exposure to other PFAS compounds, such as PFOS and and the synergistic/combined effects of being exposed. to multiple PFAS compounds (including PFOA) at the same time. (See Ex. at 3.) in short, the 08 Science Panel and C8 Health Project work allows ATSDR to start from what is already known and addressed by the CS Science Panel and 08 Health Project with respect to the adverse effectsof PFOA, and direct its resources toward studying the effects of Responders being exposed to one or more (or a combination) of the other PFAS materials through their use of PFAS Equipment. Now Is The Time To Act. it is imperative that ATSDR take action now to respond to this ongoing, imminent and substantial threat to the health of Responders across this country. Every day, more Responders are being diagnosed with cancer or other serious illnesses after working for years with PFAS?based firefighting foams or other PFAS Equipment. Every day Responders across the country are spraying PFAS-based, foams or donning gear that was made or coated with PFAS materials. (See e.g. Ex. J.) Our nation?s Responders deserve nothing less than immediate, credible, scientific answers to exactly what this mix of PFAS compounds in PFAS Equipment has done or will do to them. We already know that this particular group of Americans suffers from unusually high levels of serious disease, including multiple forms of cancer. (See Ex. 1 (example health study excerpts).) They hate a right to know whether the same equipment they relied upon?to help save lives the fire?ghting foam, fire-protection gear, and other PFAS Equipment has put their own lives at risk for these terrible diseases. ATSDR is-uniquely endowed with the legal authority and ability to fashion a response that addresses this problem in a comprehensive, coordinated, national basis among all necessary parties. ATSDR also has the rare ability and power to require those deemed responsible for such harm, including any military or other governmental entities, to pay2 for and/orfund such work. (See e. 42 U. S. C. 9604(i)(5)(D), 9607(a)(4)(D). 2) Given own recognition of the feasibility, importance, and need to study the effects of multiple PFAS exposures and its statutory authority and authorization to do so, ATSDR's continuing failure to do so provides a basis for a national class of all Responders whoused PFAS Equipment to bring a citizens? suit against ATSDR to force such action, in the United States District Court for the District of Columbia, sixty days after ATSDR receives written notice of its failure to comply with this statutory mandate. (See id. 9659.) . This letter serves as such a notice to ATSDR on behalf of our client, Mr. John Jeffrey Hermes, 6441 Cottontail Trail, Burlington, Kentucky 41005 (859689?2941), as a representative of a national class of all such Responders. Mr. Hermes is a prostate cancer Survivor who has been a career Responder for over 25 years and has used 2 See also 42 use 9604(i)(17), 9620. September 5, 2017 Page 6 PFAS Equipment during most of that career, including PFAS?based firefighting foams and gear made and/or coated with PFAS chemicals. We remain hopeful that this matter can be resolved within the next sixty days without the need for pursuing any citizens? suit. We are available to meet with you to discuss and fashion a Consent Order or other document that will allow the matterto be addressed and resolved in a coordinated, uniform manner among all impacted parties, using the prior 08 Science Panel/CB Health Project and related settlement model. Ince?r/ely, i "no/Robert A. Site RAB: Encls. (Exs. A-J) Cc: Mr. John Jeffrey Hermes (w/encls.) ROBERT A. 859.547.4306 bilott@taftlaw.com September 5, 2017 CERTIFIED MAIL RETURN RECEIPT REQUESTED Brenda Fitzgerald, MD. Director Centers for Disease Control and Prevention Administrator, Agency for Toxic - Substances and Disease Registry US. Department of Health Human Services 1600 Clifton Road Atlanta, 30329?4027 Patrick Breyese, CIH Director Agency for Toxic Substances and Disease Registry Center for Disease Control 200 Independence Ave, SW. Washington, DC 20201 Re: Request for Coordinated Nationwide PFAS Health Study and Testing and Notice of Intent to Sue Taft/ 1717 Dixie Highway, Suite 910/ Covington, Kentucky 41011 -)447( Tel. 859. 331 .:2838/Fax 513.381. 66 Scott Pruitt Administrator United States Environmental Protection Agency William Jefferson Clinton Building 1200 Ave., N.W. Mail Code: 1101A Washington, DC 20460 Jeff Sessions, Esq. United States Attorney General United States Department of Justice 950 Ave, N.W. Washington, DC 20530?0001 Ladies and Gentlemen: Millions of people across the country have been exposed to highly fluorinated chemicals (per? and polyfluoralkyl substances, including PFOA and PFOS) collectively referred to as in their drinking water supplies. EPA acknowledged the risks posed by the entire family of PFAS in its ?Long?Chain Perfluorinated Chemicals (PFCs) Action Plan,? which was released over seven years ago, but has never been fully Taft Stettinius Hollister LLP Chicago Cincinnati Cleveland [Columbus [Dayton Indianapolis] Northern Kentucky] Phoen 3 September 5, 2017 Page 2 implemented. (See Ex. A (excerpts).) EPA has, however, recently confirmed that at least one PFAS PFOA poses sufficient ?potential adverse effects for the environment and human health based on its toxicity, mobility, and bioaccumulation potential? to support investigating and addressing its presence in drinking water under the federal Superfund law, codified in the Comprehensive Environmental Response and Liability Act of 1980, as amended, 42 U.S.C. 9601 et seq. (See Ex. (excerpts) at 9.) Through the authority granted to ATSDR under that same Superfund law, ATSDR has classified PFAS as a class of chemicals that meet the definition of ?toxic substance? within the scope of purview.1 Consequently, ATSDR has developed a draft toxicological profile for PFAS, issued various statements and guidance to impacted individuals and physicians dealing with certain PFAS exposures, and even agreed to partner with a handful of state or local entities investigating specific instances of specific types of PFASdrinking water contamination in specific communities. (See Ex. C.) To date, however, ATSDR has not embarked on any coordinated, comprehensive nationwide study or investigation of the impacts on human health from the presence-of the entire class of PFAS in drinking water, or associated testing of all such impacted individuals. We write to request that ATSDR move forward immediately with sUch a national study and testing. As explained below, ATSDR has the clear power and authority to mandate a national study of PFAS health impacts and associated testing, has access to mechanisms to secure funding from responsible parties, and has a proven model to follow to implement such a study/testing. Based on our past decade of experience designing and overseeing a project to assess human health impacts from one such PFAS PFOA we stand ready to assist ATSDR in overseeing the design and implementation of a nationwide study and testing focusing on the entire class 'of PFAS chemicals through a program that could encompass and involve all affected parties, including PFAS manufacturers, PFAS users, impacted water supplies, impacted residents, and affected governmental entities/contractors and regulators, in a way that provides everyone with independent, credible scientific answers and certainty. l. ATSDR Has The Authority To Require A National PFAS Health Study and Testing And Ability To Secure Full Funding For Such Work. Under Section 104 of CERCLA, ATSDR shall ?provide medical care and testing to exposed individuals, including but not limited to-tissue sampling, chromosomal testing where appropriate, epidemiological studies, or any other assistance appropriate under the circumstances? in situations involving ?public health emergencies caused or believed to be caused by exposure to toxic substances?. (42 U.S.C. This is a non-discretionary mandate. Thus, under this provision of CERCLA, ATSDR (which, as noted above, already has classified PFAS as a ?toxic substance?) is not only See also 42 03.0. 9604(i)(18). September 5, 2017 Page 3 authorized to conduct epidemiological studies and testing in circumstances where there have been excessive PFAS eXposures, but is required to do so. EPA repeatedly has indicated that situations involving excessive levels of PFAS in drinking water quality as public health emergencies mandating immediate alternate water supplies. For example, as early as 2002, EPA entered a consent order in which it found that levels of a PFAS (PFOA) exceeding the non-regulatory threshold used by EPA at that time presented a sufficient threat of ?imminent and substantial endangerment? to warrant the provision soon as practicable? of alternative drinking water to those exposed. (See Ex. (excerpts).) EPA entered similar orders noting the threat of such ?imminent and substantial endangerment? from excessive PFAS levels in drinking water, mandating immediate alternate drinking water supplies, after EPA adopted its first provisional health advisory guidelines for short?term exposures to two different PFAS materials (PFOA and PFOS) in 2009. (See Ex. (excerpts).) EPA reaf?rmed this position as recently as January 2017 when it modified one of those same consent orders to require immediate clean water-if levels of PFAS exceeded new long-term health advisory level of no more than 0.07 for individual or combined levels of PFOA and PFOS. (See Ex. F.) EPA noted that these new, lower PFAS drinking water guidelines were based on review of "the best available peer? reviewed studies? indicating that exposure to these PFAS ?may result in adverse health effects, including developmental effects to fetuses during pregnancy or to breastfed infants low birth weight, accelerated puberty, skeletal variations), cancer . testicular, kidney) liver effects tissue damage), immune effects antibody production and immunity), thyroid effects and other effects cholesterol changes)? (Ex. G.) - actions to date confirm its recognition that studying PFAS contamination issues falls squarely within its broad authority. As recently as May 23 of this year, ATSDR released the results of its own assessment of whether an epidemiological study by the Agency of those exposed to PFAS contamination in their drinking water would be feasible. (Ex. (excerpts).) ATSDR confirmed in the context of evaluating the feasibility of studying adverse health effects amongthe adults, children, and military personnel exposed to multiple PFAS compounds in drinking water at the Pease International Tradeport that undertaking such a study could generate important ?scientific knowledge about the health effects of PFAS exposures, in particular, PFOS and exposures,? if the study could be designed to encompass a sufficiently large population of impacted people. (Id. at 2.) In order to properly and thoroughly study certain types of less common diseases (including cancer) associated with these PFAS exposures, ATSDR acknowledged that there would need to be far more than the couple hundred or even couple thousand anticipated study participants at that one site, which might be feasible if multiple sites were incorporated into the study. (Id. at 43.) even listed over 100 sites identified to date across the country where PFOS and/or have been confirmed to be present in drinking water at levels above reporting limit forthe chemicals under Unregulated September 5, 2017 Page 4 Contaminant Monitoring Rule 3 which could provide the needed, larger pool of study participants. (Id. at Table A. 1 .) II. A Proven Model Exists For Developing A National PFAS Health Study. Settlement of a prior class action lawsuit in which we represented the plaintiff class resulted in the creation of an independent scientific panel that studied the effects of PFOA-contaminated drinking water among a class of approximately 70,000 people whose drinking water supplies in West Virginia and Ohio had been contaminated with quantifiable levels of the chemical (0.05 at the'time) attributable to releases from the Washington Works manufacturing plant then?owned by E. l. du Pont de Nemours Company (?DuPont?). Through an innovative settlement with DuPont in that case (known as the ?Leach Case?), we were able to secure sufficient funds to pay for: 1) blood testing of approximately 69,000. people through a Health Project?; 2) creation of a new ?08 Science Panel? of independent world- class epidemiologists charged with con?rming which diseases Were linked to PFOA exposure among the class being studied; 3) the design and implementation by the CB Science Panel of approximately a dozen extensive epidemiological studies and retrospective exposure modeling work, including class-wide studies of the expOsed population; 4) provisions for immediate and long-term clean water/water filtration; and 5) medical monitoring/testing for all class members for each disease linked to their PFOA exposure. (See and Through that settlement, we also were able to secure a binding agreement up front Oh how the results of the independent scientific work would be used in connection with future Injury and compensation claims among the Leach Case class members including the extent to which the independent scientific work would conclusively resolve Issues of general causation as between the PFAS chemical at Issue and the class member exposures The settlement also included an agreement that all active litigation among the parties would be stayed and future filings barred (yet with all claims preserved and statutes of limitations tolled), pending the final outcome of the agreed scientific process. The work of the CB Science Panel (and the related C8 Health Project) under this prior class settlement involved only one PFAS compound (PFOA) and only one responsible party (DuPont). There is no reason, however, why this same model cannot be expanded to the current situation facing communities across the United States involving one or more (or a combination of) the other PFAS compounds in their drinking water potentially attributable to the actions of multiple responsible parties In fact, expanding the model to include multiple responsible parties and regulators provides the opportunity for creating a much bigger pool of funds and the opportunity to spread costs - among a much bigger and more diverse group. Likewise addressing the Issue within the context of a national class provides the opportunity for the reaponsible parties to fashion common, global remedies that allow for uniform, consistent relief and treatment of impacted parties and greater financial, scientific, and regulatory certainty. September 5, 2017 Page 5 ATSDR already has acknowledged the significance and utility of the 08 Science Panel/C8 Health Project model and work for addressing health issues related to PFAS exposures. As noted by ATSDR in its May 23, 2017, draft feasibility assessment for studies at the Pease International Tradeport, the 08 Science Panel?s/08 Health Project?s work, which focused on human impacts from PFOA contamination in drinking water, allows ATSDR to focus future PFAS studies on the effects from exposure to other PFAS compounds, such as PFOS and and the synergistic/combined effects of multiple PFAS compounds (including PFOA) being present in drinking water at the same time. (See Ex. at 3.) in short, the 08 Science Panel and CB Health Project workallows ATSDR to start from what is already known and addressed by the 08 Science Panel and (38 Health Project with respect to the adverse effects of PFOA, and direct its resources toward studying the effects of having one or more (or combination) of the other PFAS materials in drinking water. Ill. Now Is The Time To Act. it is imperative that ATSDR take action now to respond to this ongoing, imminent and substantial threat to the health of millions of Americans across this country. Every day, another community somewhere in the United States wakes up to news that one or more (or some combination) of an ever-expanding class of PFAS compounds (some being identified for the first time as even existing) are poisoning the drinking water that they and their families rely upon. Every day another community is being told not to drink its water or to immediately get on bottled water because the concentration of PFAS exceeds current guidelines or other health benchmarks. Residents, water suppliers, local, state and national elected officials, governmental entities, NGOs, business leaders, scientists all are demanding credible, scientific answers to exactly what this mix of PFAS compounds in the water will do to people over time? especially those who have had long term exposures over many years or may be in sensitive subpopulations, such as infants, the elderly, or the infirm. Recently, the leaders of the health departments in ?ve states New York, Michigan, New Hampshire, Vermont, and Alaska all signed a joint letter specifically asking ATSDR to undertake a national PFAS health study. (Ex. I.) In the meantime, an ever-growing number of lawsuits are being filed by a variety of lawyers asserting a myriad of different claims and theories against multiple parties under varying state laws and standards. ATSDR is uniquely endowed with the legal authority and ability to fashion a response that addresses this problem in a comprehensive, coordinated, national basis among all necessary parties. ATSDR also has the rare ability and power to require those deemed responsible for such PFAS contamination of the country?s drinking water supplies, including any military or other governmental entities, to pay for and/or fund such work. (See 42 U.S.C. 9604(i)(5)(D), 9607(a)(4)(D). Given own . recognition of the feasibility, importance, and need to study the effects of multiple PFAS 2 See also 42 u.s.c 9604(i)(17), 9620. September 5, 2017 Page 6 exposures in drinking water and its statutory authority and authorization to do so, ATSDR's continuing failure to do so provides a basis for a national class of all those negatively impacted by unstudied PFAS contamination of their drinking water supplies to bring a citizens? suit against ATSDR to force such action in the United States District Court for the District of Columbia, sixty days after ATSDR receives written notice of its failure to comply with this statutory mandate. (See id. 9659.) This letter serves as such a notice to ATSDR on behalf of our client, Dr. Arlo Paul Brooks, Jr., 92 Bella Vista Drive, Vienna, West Virginia 26105 (304-481-2946), as a representative of a national class of all persons whose primary source of residential drinking water for at least one year or more has been found to contain one or more PFAS- chemicals at a concentration above the Method Reporting Limit (MRL) for such PFAS chemical(s) established by EPA for purposes of UCMR-S, excluding any such water supply where the only PFAS found above such MRL is PFOA or is a water supply falling within the scope of the Leach Case settlement. ATSDR has identified in Table A1 to Exhibit attached hereto over 100 such water supplies across the country meeting this definition, including the municipal water supply for Vienna, West Virginia, which Dr. Brooks has used as his primary source of residential drinking water for many years. (See Ex. Table A1.) Dr. Brooks was one of the founding partners of Brookmar the entity that designed, managed, and implemented the highly successful C8 Health Project. Dr. Brooks stands ready to share his unparalleled experience with ATSDR to help the Agency- move fon/vard with the type of national PFAS study that is now required. We remain hopeful that this matter can be resolved within the next sixty days without the need for pursuing any citizens? suit. We are available to meet with you to discuss and fashion a Consent Order or other document that will allow the matter to be addressed and resolved in a coordinated, uniform manner among all impacted parties, using the prior CS Science Panel/C8 Health Project and related settlement model. f' \?fRobert A. Bilott RAB: Encls. (Exs. A?l) Cc: Dr. A. Paul Brooks, Jr. (w/encls.) DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry (ATSDR) Atlanta, GA 30333 November 6, 2017 Robert A. Bilott Taft, Stettinius Hollister LLP 1717 Dixie Highway, Suite 910 Covington, Kentucky 41 01 1 -4704 Dear Mr. Bilott: Thank you for your letters of September 5, 2017, and October 6, 2017, to Dr. Brenda Fitzgerald, Director of the Centers for Disease Control and Prevention (CDC), and Administrator, Agency for Toxic Substances and Disease Registry Mr. Scott Pruitt, Administrator of the US. Environmental Protection Agency Mr. Jeff Sessions, US. Attorney General, Department of Justice; and me regarding per- and poly?uoralkyl substances (PF AS) in drinking water. I am responding on behalf of shares your concerns about this important public health issue. Over the last several months, we developed a strategy to provide guidance and direction for carrying out a potential national study on PFAS. Earlier this year, we initiated a federal inter-agency coordination meeting on PF AS that included the EPA, National Institutes of Health, Food and Drug Administration, and others. The purpose of the meeting was to engage other federal agencies on PF AS-related activities and identify areas of synergy and opportunities for coordination across government agencies. This cross-collaboration with other agencies and departments allows us to identify expertise, share current research, and identify resources to address our approach to understanding the health impact of PFAS exposure. Thank you again for your letter. We hope this information is helpful to you. If you would like to set up a call to discuss efforts related to PFAS, please contact Ms. Kimberly Dills on my staff at kid4@cdc. gov or (404) 639-2720. Sincerely, Patrick Breysse, IH Director National Center for Environmental EPA Launches Cross-Agency Effort to Address PFAS U.S. EPA News Releases US EPA Page 1 of 2 We?ve made some changes to EPA. gov. If the information you are looking for is not here, you may be able to ?nd it on the EPA Web Archive or the January 19, 2017 Web Snapshot. (5. Unilud Sum ?13 Environmental PKG-EMWH . News Releases from Headquarters Research and Development (0RD) EPA Launches Cross-Agency Effort to Address PFAS 12/04/2017 Contact Information: EPA Press Of?ce (pi'essggepagov) WASHINGTON ??Today, the U.S. Environmental Protection Agency (EPA) is announcing a cross- agency effort to address per and polyfluoroalkyl Substances (PFAS). PFAS, which includes PFOA, PFOS and GenX, are a diverse group of compounds resistant to heat, water, and oil that are persistent in the environment and resist degradation. ?Protecting public health is highest priority and through these efforts we are taking the lead to ensure that communities across the country have the tools they need to address these chemicals,? said EPA Administrator Scott Pruitt. ?The work we are doing shows our commitment to clean air, land, and water and to working side-by-side with our state, local, and tribal partners.? As part of the agency?s work, EPA will: Identify a set of near-term actions that EPA will take to help support local communities. - Enhance coordination with states, tribes and federal partners to provide communities with critical information and tools to address PFAS. - Increase ongoing research efforts to identify new methods for measuring PFAS and filling data gaps. 0 Expand proactive communications efforts with states, tribes, partners and the American public about PF AS and their health effects. efforts will build on the work that the Agency has done to establish non?regulatory drinking water health advisories for PFOA and PFOS. The Agency?s water and research of?ces will lead these efforts and they will bring together expertise from across the Agency including top scientists from 12/13/201 7 EPA Launches Cross-Agency Effort to Address PFAS US. EPA News Releases I US EPA Page 2 of 2 air, chemicals, land, research, and water of?ces. In addition to a cross-program effort, EPA is also tapping its regional of?ces to enhance cooperation with partners at the state and local levels and to provide on?the-ground knowledge about speci?c issues?and address PF AS nationwide. Additional information: LAST UPDATED ON DECEMBER 4, 2017 12/13/2017