The Delay Game. How the Chemical Industry Ducks Regulation of the Most Toxic Substances. Authors Jennifer Sass, PhD Daniel Rosenberg, JD.

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1 The Delay Game How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces October 2011 Authors Jeifer Sass, PhD Daiel Roseberg, JD

2 About NRDC NRDC (Natural Resources Defese Coucil) is a atioal oprofit evirometal orgaizatio with more tha 1.3 millio members ad olie activists. Sice 1970, our lawyers, scietists, ad other evirometal specialists have worked to protect the world s atural resources, public health, ad the eviromet. NRDC has offices i New York City, Washigto, D.C., Los Ageles, Sa Fracisco, Chicago, Motaa, ad Beijig. Visit us at Ackowledgmets The authors are very grateful for fudig for this project from: The Bauma Foudatio, The Forrest & Fraces Latter Foudatio, The Joh Merck Fud, The Johso Family Foudatio, the Passport Foudatio, ad the Zierig Family Foudatio. We would like to thak the followig idividuals for their expert peer review: Drs. Richard Clapp, Ro Melick, ad David Ozaoff. We are also grateful to aoymous govermet peer reviewers. We thak the followig NRDC colleagues for their assistace with research ad peer review of this paper: Drs. Lida Greer, Gia Solomo, Sarah Jasse, ad David Leett. We thak James Meiert for help with formattig ad referece checkig. NRDC Director of Commuicatios: Phil Gutis NRDC Deputy Director of Commuicatios: Lisa Goffredi NRDC Publicatios Director: Lise Steves NRDC Publicatios Editor: Carlita Salazar Productio: Taja Bos

3 Table of Cotets Executive Summary...2 Itroductio...3 The Four Dog Defese...3 Case #1: Trichloroethylee...6 Case #2: Formaldehyde...10 Case #3: Styree...16 Coclusio ad Recommedatios...18 Edotes...19 PAGE 1 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

4 Executive Summary For decades, the Evirometal Protectio Agecy s (EPA) efforts to protect the public from health risks of hazardous chemicals have bee hidered by chemical compaies ad the Toxic Substaces Cotrol Act (TSCA), the mai law used to regulate chemicals i the Uited States. This paper examies the role of the chemical idustry, polluters, their paid cosultats, ad trade associatios i prevetig the EPA from reachig coclusios about the toxicity ad huma health risks of hazardous chemicals. Through the case studies of three commo chemicals ad widespread pollutats trichloroethylee (TCE), formaldehyde, ad styree this paper reveals how idustry has maipulated the regulatory process to prevet sciece-based assessmets of toxicity ad huma health risks from becomig policy. The Toxic Substaces Cotrol Act (TSCA) is i desperate eed of reform. Its weakesses have allowed chemical compaies to exploit the act by thwartig the EPA s attempts to fialize health assessmets ad delayig regulatio of chemicals sometimes for decades. The chemical idustry s roadblocks ofte follow predictable patters: Attack early drafts of health assessmets Force ew reviews Hold workshops populated with idustry-fuded paelists Itroduce ew idustry-fuded studies whe assessmets are close to fial Force more reviews Elist elected officials to assist with political iterferece Attack ew assessmet drafts Usig these tactics, the chemical idustry has effectively preveted the EPA from achievig its missio to protect huma health. This report details how the U.S. legal system ad TSCA itself have helped the chemical idustry to be effective i its efforts to delay regulatios. Cogress eeds to reform TSCA to make it a more effective regulatory tool. The chemical idustry should ot be able to edlessly postpoe regulatory decisios while profitig from uregulated chemical sales util all scietific cotroversies ad ucertaities, large ad small, have bee elimiated. With good public policy, the EPA should be empowered to make the best decisios it ca o a timely basis usig existig iformatio, ad apply ew sciece to update its evaluatios as it becomes available. PAGE 2 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

5 Itroductio The legal system has give the chemical idustry home field advatage for 35 years by placig the burde of proof o the govermet to establish that chemicals are harmful. This approach has allowed the idustry to wi almost every fight over whether a chemical is harmful, simply by raisig repeated questios about scietific studies, askig for assessmets to be revisited, ad otherwise playig what we call the delay game. The Itegrated Risk Iformatio System (IRIS) is a EPA program i which staff scietifically assess the health effects of chemicals already i commercial use. I the IRIS program, the EPA risk assessors evaluate all the relevat sciece ad determie the acceptable level of exposure to a chemical, i the air, water, food, or soil. IRIS assessmets are ot regulatios themselves, but they are frequetly used by regulators at the EPA, i the 50 states, ad aroud the world to set health-based stadards for chemicals. To maitai profits, the chemical idustry is motivated to prevet the EPA from updatig assessmets of a chemical s hazard uder the IRIS system, especially if the assessmet is likely to provide a first-time evaluatio that a chemical is hazardous, or to show that the chemical is more dagerous tha previously thought. The idustry has goe to great legths to prevet may of these assessmets icludig the three detailed i this report from beig completed. The loger the EPA is preveted from updatig its assessmets of formaldehyde, styree, TCE, ad other chemicals, the less pressure is leveraged o the idustry to stop makig, sellig, ad usig those chemicals, ad to replace them with safer alteratives. Ufortuately, uder the curret law there is o eforceable deadlie for the EPA to complete its chemical assessmets, o harmful util prove safe iterim stadards to limit chemical exposures util assessmets ca be completed, ad o cosequeces for idustry if the EPA fails to complete (or is preveted from completig) a assessmet. Combied with the iocet util prove guilty approach of the curret law toward chemicals where the EPA must cosider a chemical safe util it ca reach a official coclusio that it is harmful above certai levels idustry has every icetive to resist data collectio ad data requests, ad to argue with every study i order to delay the completio of those assessmets. 1 The Four Dog Defese The delay game ivolves what is by ow a well-recogized series of tactics that started decades ago whe idustry challeged the hazards of lead, tobacco, ad asbestos. These methods have eared a ickame the Four Dog Defese. The basic steps of the defese are: 1. My dog does ot bite. At first, the compay deies that its product is harmful. This may iclude attempts to discredit scietific studies, or authors of studies, that show harm ad geerate its ow studies desiged to show o harm. 2. My dog bites, but it did t bite you. Idustry cocedes that the chemical is potetially harmful, but isists that o oe is exposed to it. This argumets works best if idustry does t test or moitor for the chemical absece of data is ofte used as a reaso to argue that there is o exposure. PAGE 3 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

6 3. My dog bit you, but it did t hurt you. Idustry admits that people or wildlife are exposed to the chemical, but deies that the exposure caused harm. Idustry cocedes that the chemical is harmful at very high doses or uder urealistic test coditios, but ot at the lower levels or real-world scearios to which people or wildlife are actually exposed. Or the argumet may focus o differeces betwee humas ad laboratory aimals, allegig that harm such as cacer observed i aimal experimets is ot relevat to people. 4. My dog bit you, ad hurt you, but it was t my fault. Idustry admits the chemical is makig people sick, but tries to shift the blame to avoid regulatio ad liability. Possible culprits are improper use, use uder past practices o loger followed (before we kew better), other chemicals, medicatios, smokig, or poor health. Routiely, idustry will ask the govermet to delay fializig a health assessmet while it coducts a ew study, which it promises will settle ay scietific cotroversies that the idustry has itself geerated alog the way. These additioal studies ca add years if ot decades to regulatory decisiomakig, leavig the exposed public with old ad outdated iformatio ad iadequate protectios i the meatime. I fact, the ew studies promised by idustry to resolve cotroversies it has created rarely resolve the debate. More typically, ew studies simply force additioal aalyses upo the EPA, addig to the delay. Sometimes, oce the idustrysposored studies are completed, compaies will sposor a workshop of scietists who are called idepedet but have fiacial ties to chemical firms, to reach their ow coclusios about the real toxicity of a chemical. This ew aalysis ca the be deployed to challege the EPA s assessmet. Other times, idustry simply pluks all its ew studies dow for the EPA to sort through. I either case, by the time the EPA fially gets back o track with its assessmet possibly modified i light of the idustry data, possibly ot idustry will ofte ask for a ew delay so it ca sposor more studies. The process is caught i a time loop, except time is oly stopped for the regulatios, while the use, maufacture, sale, ad evirometal exposure to chemicals cotiues uabated. The recurrig failure of the EPA to complete IRIS assessmets ad set ew legal limits o chemicals is so extreme that it became the focus of a ivestigatio ad report i 2009 by the Govermet Accoutability Office (GAO), a idepedet ivestigative arm of Cogress, which cocluded that the EPA s chemical assessmet programs were some of the highest risk of failure programs i the etire federal govermet. 2,3 Oe of the most fudametal problems idetified i the report was the lack of legal authority uder TSCA for the EPA to obtai risk iformatio from chemical compaies. TSCA is widely cosidered to be the largest failure of the major evirometal laws eacted i the 1970s. The law gradfathered 62,000 chemicals, with o requiremet for them to be tested or to meet a safety stadard. The law also placed the burde of proof o the EPA to establish that a chemical was usafe before it could take actio, rather tha requirig the chemical idustry to prove that its products were safe before they could be marketed. What is worse, the law set impossibly high hurdles for the EPA to require testig of chemicals, or to take actio agaist those chemicals already kow to be usafe. As a result, the EPA has oly bee able to require testig o approximately 300 of the 62,000 gradfathered chemicals, ad take limited regulatory actio o oly five chemicals. As a example of the problem, despite a 10-year effort to ba asbestos ad overwhelmig evidece that it is deadly, the EPA lost a idustry challege i court ad was ot allowed to ba existig uses. As a result, although compaies o loger mie asbestos i the Uited States, we cotiue to import products cotaiig asbestos ad te thousad people die each year from past ad o-goig exposures to asbestos. These deaths represet the devastatig failure of TSCA that cotiues today. Marily s Story Asbestos has destroyed our family. Joe died whe our kids were oly 8 ad 10 [2003]. They ve had to go through critical parts of their lives without the woderful father that they kew ad loved. As a widow, I had to lear to care for myself ad our youg childre without the comfort ad love from [the] ma I loved so much. Asbestos made me both a mother ad a father. I 2009, all three of us are baffled that asbestos is still legal ad that o real cure is available for mesothelioma victims. 4 Marily, Pesylvaia. I additio to TSCA s failure to regulate existig chemicals, the law strictly limits how much risk iformatio the EPA ca require from chemical maufacturers for ew chemicals. As a result, most of the 22,000 ew chemicals that have bee added for use sice 1976 were approved with little or o data o risks to health or the eviromet. The Natioal Toxicology Program (NTP), a public chemical testig program housed withi the Natioal Istitutes of Evirometal Health Sciece (NIEHS) was created i 1978 partly to address this deficiecy of risk iformatio. However, the umber of chemicals NTP ca test is severely limited by its small budget, ad it caot hope to fill the gap created by the weak TSCA. Although the chemical idustry has claimed sice August 2009 to be i support of reformig TSCA ad achievig better regulatio of chemicals to protect the public, it has challeged virtually every EPA actio, assessmet, or fidig that might lead to such icreased protectio. PAGE 4 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

7 The three case studies preseted i this report demostrate the idustry s effectiveess i blockig the EPA s attempts to fialize a health assessmet. The roadblocks follow a patter: Step 1: Attack the EPA assessmet Step 2: Prevet the EPA from fializig assessmet by: Submittig volumes of data or public commets to challege or discredit studies showig harm Callig for additioal review by aother scietific committee Usig Cogress to delay the assessmet via letters or budget riders Gettig the assessmet delayed by the Office of Maagemet ad Budget Step 3: Sposor ew studies to support oe or more dogs from the Four Dog Defese Step 4: Sposor a meetig to review ew studies Step 5: Require the EPA to review ew studies Step 6: Require the EPA to redraft its assessmet Step 7: Attack the EPA reassessmet (back to Step 1) The three chemicals i our case studies are represetative of a sigificat problem. Accordig to a recet aalysis of the IRIS Program by the Ceter for Progressive Reform (CPR), there are roughly 500 chemicals i the IRIS public database ad about 300 to 400 that are more tha 10 years old, awaitig either iitial or updated assessmets. This is a backlog that, at the curret rate of ie assessmets per year (up from two per year durig the Bush admiistratio), would take 55 years to complete. Headlies from The Delay Game To illustrate the attempts of the chemical idustry to block risk assessmets ad regulatios, below is a sample of headlies i the Washigto beltway publicatio Iside EPA. Note that there were o headlies i 2009 of idustry commedig the EPA for ay risk assessmet ad oe aoucig that idustry was takig precautioary or proactive steps to remove a existig chemical from the market. Idustry Fears New Formaldehyde Cacer Data May Guide EPA Risk Study Idustry officials fear that ew studies that are leadig iteratioal ad federal toxicology researchers to call for a upgrade i formaldehyde s listig as a huma carcioge may ifluece ad tighte EPA s pedig study of the chemical s risks, which the agecy is uder pressure to sed to the Natioal Academy of Scieces (NAS) for review. (Iside EPA, December 15, 2009) Idustry Eyes Studies To Rebut Fidig Of Formaldehyde-Leukemia Lik Formaldehyde makers ad users are strivig to rebut a ew study likig exposure to the chemical with myeloid leukemia by lauchig their ow studies of hudreds of formaldehyde-exposed workers, as EPA works o a assessmet of the chemical that idustry fears will adopt several expert bodies fidig that it is a huma carcioge. (Iside EPA, February 23, 2010) Idustry Urges EPA To Await New Formaldehyde Study For Air Toxics Rule Idustry is criticizig EPA's reliace o what critics say is a flawed 1991 risk assessmet of formaldehyde i settig a proposed air toxics stadard for wood furiture maufacturig facilities, sayig EPA should stall the rule util the Natioal Academy of Scieces (NAS) completes its review of a ew agecy formaldehyde risk study. (Iside EPA, March 8, 2011) Court Blocks Idustry Suit O Styree Cacer Listig, Clearig EPA s Path A federal court has coditioally deied a idustry motio seekig to remove styree from the Natioal Toxicology Program's (NTP) listig as a carcioge, a decisio which could pave the way for EPA to move forward o its ow logstalled risk assessmet of the chemical that is expected to iclude a first-time estimate of its cacer risks. (Iside EPA, July 14, 2011) Idustry Hopes NAS Study Defese Bolsters Bid To Softe EPA s TCE Limits Chemical idustry officials are poitig to a recetly released Natioal Academy of Scieces (NAS) letter defedig its 2009 report o chemicals i drikig water at a North Carolia Marie Corps Base to bolster their efforts to softe EPA s draft risk assessmet o the solvet trichloroethylee (TCE), oe of the chemicals NAS studied. (Iside EPA, Jue 3, 2011) PAGE 5 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

8 Case #1: Trichloroethylee Trichloroethylee (TCE), a chloriated solvet used primarily for metal degreasig most otably for jet parts is a widespread drikig water cotamiat that is leachig from military bases ad idustrial sites throughout the coutry. I additio to cacer, TCE has bee liked with harmful effects to the cetral ervous system, kidey, liver, immue system, male reproductive system, ad developig fetus. The EPA has bee tryig to fialize its assessmet of TCE for 22 years. The EPA s latest goal is to fialize it by the ed of Although it is still used today, most TCE pollutio comes from the improper disposal of waste from past uses. Approximately 2.9 millio pouds of TCE waste is produced aually i the Uited States, with most of it emitted ito air, accordig to the most recet data available. 5 TCE has bee idetified at approximately 760 Superfud sites, icludig may old military sites. 6 The public is exposed through drikig ad washig with cotamiated water, as well as breathig air cotamiated with TCE vapor that ca itrude ito homes via cotamiated soil. 7 The EPA s assessmet of TCE last doe through the IRIS program i 1987 is early 25 years old. 8 It had classified TCE as a probable huma carcioge. The Food ad Drug Admiistratio (FDA) had baed the use of TCE i food te years earlier. I 1989, the EPA started to update its TCE cacer assessmet, but did t issue a draft for public ad peer review for a doze years, util The 2001 draft classified TCE as highly likely to cause cacer, cosistet with the World Health Orgaizatio s (WHO) classificatio of probably carciogeic to humas (IARC 1995, Group 2A), ad the Natioal Toxicology Program s listig of reasoably aticipated to cause cacer through both ihalig cotamiated air ad through drikig cotamiated water (9 th Report o Carcioges, 2002). 10 Ulike other programs that oly describe the qualitative hazards of chemicals, the EPA IRIS program calculates umerical risk estimates. The 2001 EPA draft for TCE calculated that the chemical was five to 65 times more toxic tha previously estimated. 11 It also idetified childre as a susceptible populatio, ad oted that co-exposure to some other chemicals may augmet the toxicity of TCE, emphasizig that it is importat to cosider the cumulative effects of TCE alog with other evirometal cotamiats whe coductig a risk assessmet. 12,13 This approach, ahead of its time, foreshadowed a umber of the recommedatios that would be made eight years later i a 2009 ladmark report of the Natioal Academies called Sciece ad Decisios: Advacig Risk Assessmet. 14 PAGE 6 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

9 Attack Agecy Assessmets Because the TCE draft risk assessmet laid the groudwork for much more striget cleaup stadards ad exposure limits tha the origial 1987 assessmet, it triggered a decade-log firestorm of criticism from the chemical idustry, the Departmet of Defese (DOD) ad the Departmet of Eergy (DOE). The DOD ad DOE together are resposible for about 1,400 TCE-cotamiated dump sites i the atio, 15 givig them a icetive to avoid striget cleaup requiremets. The criticism paralyzed the EPA, ad kept it from fializig its aalysis. I a good-will effort to achieve a level of scietific cosesus, the EPA hosted meetigs i 1993 ad 1995, ad co-sposored a series of workshops with the Petago ad the Halogeated Solvets Idustry Alliace, Ic. (HSIA) leadig up to the draft. 16, 17,18 Despite this early effort to cosider broad viewpoits, the Petago, the biggest TCE polluter, protested that the EPA s 2001 draft was based o flawed sciece, ad lauched a aggressive campaig to have the assessmet withdrw. 19 Debbie s Story We discovered i August 2005 that our home was cotamiated with TCE. My husbad passed i November Prior to his passig he had bee diagosed first with Parkiso s disease, reyolds pheomea ad peripheral europathy, ad later, lug cacer. I too had peripheral europathy ad respiratory problems. I foud two immediate eighbors who also passed from respiratory problems. Oe of my eighbors was diagosed with cacer of the thymus, ad has started a health study of our eighborhood. Debbie, Otario, Caada. Idustry-sposored scietists joied i the campaig, writig a letter objectig to the 2001 EPA draft assessmet of TCE risks. 20,21 The Air Force eve wet so far as to sed a official letter opposig use of the 2001 risk estimates at its Lowry Air Force Base i Colorado, specifically i order to block better cleaup. 22 The letter argued that the EPA s remediatio plas should be based o its previous cacer risk estimates, give that the Departmet of Defese (DOD) officially disagrees with the coclusios ad methodologies used by the EPA ad called the EPA assessmet ivalid, still i draft form, ad subject to chage. 23 Usig circular logic, the DOD criticized the EPA assessmet, which blocked it from beig fialized ad the suggested that regulators reject the assessmet because it was beig criticized ad still i draft form. Despite tremedous pressure to delay, ad i spite of the criticism from idustry ad the Petago, the EPA wet ahead ad set its TCE draft assessmet to its Scietific Advisory Board (SAB) i 2002 for peer review by idepedet scietific experts. The SAB issued a very favorable report, supportig the EPA s characterizatio of TCE s cacer risk ad advisig the agecy to fialize the draft followig mior revisios. 24 Noetheless, Bush Admiistratio political appoitees forced the EPA to pull back the assessmet. 25 EPA scietist Vicet Cogliao, the mai author of the 2001 assessmet ad ow Actig Director of the EPA s IRIS chemical review program, idetified both the Bush White House ad the Petago as havig created sigificat behid the scees oppositio to the assessmet. 26 Prevet the Agecy from Fializig Assessmet Some states, desperate for a updated TCE hazard umber i order to begi cleaup at hazardous waste sites withi their borders, adopted the more health-protective 2001 risk estimates despite their still-draft status, sice they represeted the best available sciece at the time. By early 2003, the Colorado Departmet of Public Health ad Eviromet was oe of these states, ad it had begu to apply the 2001 risk estimates to clea up requiremets. Bush Admiistratio political appoitee Paul Gilma pressed regioal Superfud directors to adopt weaker toxicity stadards tha those outlied i the draft assessmet. 27 Colorado stood its groud. It was joied by New Jersey ad eight other regioal EPA offices i implemetig the 2001 draft assessmet recommedatios. 28 I early 2003 a Court of Appeals rulig allowed a classactio suit to proceed agaist a Illiois factory pollutig earby eighborhoods with TCE. The decisio opeed the way for future tort liability claims agaist idustry for TCE cotamiatio. 29 I order to try ad fialize its assessmet, i 2004 the EPA hosted a symposium of ew sciece. At the symposium, however, several DOD-sposored scietists preseted data arguig that TCE was ot as toxic as the EPA had foud. 30 Joe s Story I worked as a mechaic for about six years. Day i ad day out I used solvet cleaers [whose mai igrediet was TCE]. Sometimes we would had-fill small bottles of the chemicals, ad it would spill all over our hads. I felt lightheaded ad auseous whe usig the cleaers, but mostly it irritated my lugs ad my eyes bured. Several mechaics I worked with have sice died from lymphoid cacers. Joe, West Virgiia Sposor New Studies The data itroduced at the 2004 symposium focused o the third ad fourth dogs i the Four Dog defese my dog bit you but did ot hurt you (TCE is ot as harmful as the EPA supposes; rat cacers are ot predictive of humas) ad my dog bit you ad hurt you but it was ot my fault (past practices were at higher doses; the people who claim TCE gave them cacer also smoked). PAGE 7 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

10 Require the Agecy to Review New Studies The Petago forced the draft ito a further delay by isistig o a cosultatio from the Natioal Research Coucil of the Natioal Academies (NRC, or Academies). This cosultatio took two more years ad three quarters of a millio dollars of taxpayer moey. Noetheless, whe it was over, the 2006 NRC report defeded the EPA s assessmet, ad urged the EPA to fialize it expeditiously. 31 The same year, the Los Ageles Times reported that TCE had cotamiated 23 sites i the Eergy Departmet's uclear weapos complex. 32 Hudreds of waste sites i the Uited States are cotamiated with trichloroethylee, ad it is well documeted that idividuals i may commuities are exposed to the chemical, with associated health risks. Thus, the committee recommeds that federal agecies fialize their risk assessmet with curretly available data so that risk maagemet decisios ca be made expeditiously. Natioal Academies report o TCE, I the sprig of 2007, six years after issuace of the 2001 draft, the Bush Admiistratio side-stepped the sciece by issuig a rule exemptig the military ad certai idustries from laws that would put a limit o air emissios of TCE ad other halogeated solvets. 34 This exemptio was challeged i court by evirometal groups. I 2009, the Obama Admiistratio agreed to recosider the Bush-era air emissio exemptios. The outcome of that process is still pedig. 35 Challege the Agecy s New Draft Assessmet I 2009, the EPA staff agai updated its still-draft TCE assessmet, this time classifyig TCE as carciogeic to humas by all routes of exposure, based maily o its high risk of causig kidey cacers, but also o No-Hodgki s lymphoma ad liver cacer. 36, 37 I additio to cacer, the 2009 draft liks TCE exposure with elevated risks of harmful o-cacer effects o the huma cetral ervous system, kidey, liver, immue system, male reproductive system, ad the developig fetus. 38 Not surprisigly, polluters lied up i oppositio to the 2009 draft. 39 A ew Scietific Advisory Board was coveed to review the ew draft, ad oce agai it backed up the EPA s scietific assessmet. The review process, though, took time ad allowed cotiued exposure while stricter clea up ad emissios stadards were delayed. I the case of TCE, idustry achieved two decades of delay, but ultimately the EPA s sciece wo out. 40 I the ed, idustry was dealt a harsher blow because the scietific stadards were raised as a result of ew sciece: 1. The cacer data stregtheed sigificatly, leadig the EPA to classify TCE as carciogeic rather tha likely carciogeic to humas. 2. Evidece of immue toxicity emerged. 3. Data o fetal cardiac effects associated with TCE stregtheed. Iroically, oe of the key kidey cacer studies used i the stroger 2009 assessmet was sposored by the chemical idustry (Charbotel et al, 2006) Fuded by the Europea Chloriated Solvets Associatio, the study showed a twofold elevated risk of kidey cacer i TCE exposed workers. Curretly, the idustry is attemptig to discredit this study by sayig that it has methodological flaws. 41,42 The 2009 assessmet was rumored to be fialized ad issued to the public i the last few work days before the September 5 Labor Day log weeked, However, i a surprise retreat it was held back o the Friday before the log weeked. O the same day IRIS draft assessmets of two other chemicals 1,4 dioxae ad -butaol that had already bee made available for public commet o August 31 were pulled back without ay explaatio other tha a website ote that the two assessmets were temporarily uavailable. 43 Although it is ot kow whether this order origiated with EPA Admiistrator Lisa Jackso or at a higher level, co-icidetally o the same day the White House ordered the EPA to withdraw proposed health-protective ozoe air quality stadards that were calculated to reduce risks of heart attacks, asthma attacks, ad eve deaths from smog-related diseases. 44,45 The TCE health assesmet was fialized o September 28, as this report wet to press. PAGE 8 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

11 TCE Timelie Food & Drug Admiistratio bas TCE from food uses 1987 TCE assessmet first o-lie (EPA IRIS database) classifies TCE as probably causes cacer 2001 The EPA issues a draft for review classifies TCE as highly-likely to cause cacer 2001 Departmet of Defese opposes the draft assessmet 2006 Natioal Academy of Scieces recommeds that the EPA fialize its assessmet as soo as possible 2007 Bush Admiistratio exempts military ad others from limitig TCE air emissios 1989 The EPA withdraws cacer assessmet ad iitiates a ew assessmet 2004 The EPA hosts a symposium to review ew sciece 2009 Obama Admiistratio reviews Bush era exemptios States start to use the draft risk estimates for clea ups The EPA s Scietific Advisory Board peer reviews assessmet ad recommeds it be fialized 2009 The EPA updates draft assessmet agai classifies TCE as kow to cause cacer by all routes of exposure PAGE 9 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

12 Case #2: Formaldehyde Formaldehyde is a cacer-causig chemical used primarily to maufacture plywood, particleboard, resis, ad glues. It off-gasses from these household products ad cotamiates idoor air. Formaldehyde also pollutes outdoor air as a igrediet i vehicle fuel emissios. I additio to causig cacer, formaldehyde is a powerful irritat, creatig a burig sesatio i the eyes, ose ad throat ad triggerig respiratory difficulty i some asthmatics. The EPA has bee workig o a updated health assessmet sice 1998 ad has just recetly begu a ew draft. Formaldehyde is a high volume idustrial chemical; several millio workers are occupatioally exposed to it i the Uited States at ay give time. 46, 47 Approximately 14.5 millio pouds of formaldehyde waste is produced aually i the Uited States, with almost five millio pouds emitted ito air ad most of the rest goig to waste disposals, accordig to the most recet data available. 48 The geeral public is commoly exposed whe idoor air is cotamiated with formaldehyde fumes emitted from the adhesives used to make the particleboard ad plywood i our home furiture, ad kitche cupboards. 49 Although idoor air levels ted to be about 10 times higher tha outdoor air levels, formaldehyde is also a cotamiat of cocer outdoors because it is emitted from vehicles ad other sources of fuel combustio. 50 Attack Agecy Assessmets There is o loger ay questio that formaldehyde causes cacer i people. It causes cacer of the ose ad asal cavity i lab rats ad, ufortuately, i people who are ulucky eough to be exposed to this chemical through workplace cotamiated air. Formaldehyde was classified i 2009 as kow to cause cacer i humas by the Iteratioal Agecy for Cacer (IARC), the sciece arm of the WHO, ad also the Natioal Toxicology Program (NTP), a part of the Natioal Istitutes of Health. 51,52 However, the EPA s job with formaldehyde, as with TCE, is more challegig tha the jobs of IARC ad NTP; it must coduct a quatitative aalysis to develop a safe level of exposure. Thus these coclusios from other authoritative bodies do ot allow the EPA to complete its task. Although the lik betwee formaldehyde PAGE 10 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

13 ihalatio ad cacers of the ose ad asal cavity has bee widely accepted, a log debate has raged over whether or ot formaldehyde also causes leukemia, ad over the cacer potecy of formaldehyde (how much formaldehyde causes how much cacer). Sposor New Studies For more tha 12 years, the EPA has attempted to update its formaldehyde risk assessmet. The formaldehyde idustry has blocked the assessmet from beig fialized by usig the first dog of the Four Dog Defese: my dog does t bite. Idustry has objected to the EPA s classificatio of formaldehyde as a kow huma carcioge (Group A), ad has vehemetly opposed the EPA s fidig that formaldehyde may be liked with cacers other tha i the ose ad asal cavity. Part of the idustry s cocer may be its potetial legal liability if formaldehyde is recogized as a more harmful chemical. If formaldehyde is officially liked to the more commo leukemia ad lymphoma cacers, that opes the possibility of litigatio from exposed workers ad members of the public (icludig all the people livig i govermetprovided trailer housig after hurricaes Katria ad Rita). The IRIS Program published its first formaldehyde risk assessmet olie i 1989, more tha 20 years ago, idetifyig risks oly from eatig or drikig formaldehyde, but ot from breathig it. 53 I 1991, the EPA added a risk estimate for breathig formaldehyde-cotamiated air, ad classified the chemical as a probable huma carcioge (Group B1) based o strog evidece of respiratory tract cacer i laboratory aimal studies ad some cacer data from exposed people. 54 Challege the Agecy s New Draft Assessmet Several years later, i 1998, the EPA iitiated a systematic update. I respose, i 2001 the idustry research group Chemical Idustry Istitute of Toxicology (CIIT) challeged the EPA exposure limit with a mathematical (theoretical) model ad ew risk estimates from research that it sposored. 55 Sigificatly, the CIIT model oly accouted for cacers of the ose ad asal cavity; other cacers such as leukemia of the blood were ot icluded. Also, because of mechaistic assumptios i the model (e.g. excessive reliace o cytotoxic/irritat effects at high doses), lowdose risks due to this chemical s potetial to damage a cell s geetic material may have bee uderestimated. The cacer risk estimates predicted by the CIIT model were thus thousads of times lower tha the estimate from the EPA, suggestig it was a very weak carcioge. 56 I other words, idustry called out the third dog of the Four Dog Defese: my dog bit you, but it did ot hurt you. INDUSTRY GROUP FAILS TO REPORT FORMALDEHYDE FINDINGS I 1981, the Chemical Idustry Istitute of Toxicology (CIIT), sposored rodet studies that demostrated formaldehyde ihalatio over a lifetime was associated with death from boe marrow hyperplasia ad leukemia. 57 However, CIIT failed to report o these fidigs i its 1983 publicatio of the study. 58 CIIT also failed at the time to report to the EPA its fidigs o blood ad boe cacer, eve though it is required by law for idustry groups to provide toxicity iformatio to the EPA. Moreover, i 2004 two CIIT researchers appear to have dow-played their ow fidigs, istead statig publicly: The possibility that ihaled formaldehyde might iduce various forms of distat-site toxicity has bee proposed, but o covicig evidece for such toxicity has bee obtaied i experimetal studies. 59 Public health suffered a blow i 2003 whe, i the absece of a fialized IRIS assessmet, the EPA Air Office adopted the idustry-modeled umbers i its proposed rule, exemptig dozes of plywood facilities from adoptig legally-required pollutio cotrols for formaldehyde. 60 The rule was adopted a year later, despite sigificat public outrage. The rule was evetually overtured by a NRDC court challege i 2007, after a federal court foud that the EPA had created a illegal loophole ad ulawfully exteded the compliace deadlie. 61 Prevet the Agecy from Fializig Assessmet I order for the Air Office to use risk umbers from idustry i its proposed rule, it eeded to delay the IRIS program from fializig its assessmet. It did this with pressure from high level Bush Admiistratio political maagers at the EPA, who used the argumet that IRIS should await a update of the epidemiology studies before completig its assessmet. 62 I the meatime, the sciece showig harm from formaldehyde, icludig leukemia, cotiued to stregthe. I 2003, the NCI reported evidece of a associatio betwee workplace formaldehyde ad leukemia i a study of 26,000 workers. 63 This was followed by aother large govermet study reportig similar results, this time i 11,000 garmet workers studied by the Natioal Istitute of Occupatioal Safety ad Health (NIOSH). 64 Sposor New Studies I respose to the ew sciece, i 2004 idustry formed a ew coalitio called the Formaldehyde Coucil, Ic. (FCI), self-described as represetig the leadig producers ad users of formaldehyde i the Uited States. 65 Almost immediately after its formatio, FCI-sposored scietists published its ow re-aalysis of the govermet fidigs to specifically dispute the lik betwee leukemia ad formaldehyde. 66 PAGE 11 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

14 Require the Agecy to Review New Studies I 2004, at the behest of the FCI, Seator James Ihofe demaded that the EPA postpoe the revisios of the formaldehyde risk assessmet util the study could take ito accout idustry data, a move that would delay ew protective regulatios. 67, 68 The EPA acquiesced to Seator Ihofe s demad, meaig that usafe exposures would cotiue. TRAILER RESIDENTS SUFFER AFTER HURRICANES I 2005, hurricaes Rita ad Katria devastated the Gulf Coast, triggerig a eed for temporary housig. The Federal Emergecy Maagemet Agecy (FEMA) provided approximately 100,000 trailers to homeless residets i Louisiaa ad Mississippi. Soo after movig i, however, residets bega complaiig about respiratory symptoms that were subsequetly liked to formaldehyde off-gassig iside the trailers. More tha three years later, followig various Cogressioal hearigs ad ivestigative reports, the Director of the Ceters for Disease Cotrol ad Prevetio (CDC), Dr. Julie Gerberdig, fially aouced publicly that levels of formaldehyde i the trailers were high eough to icrease the risk of cacer ad respiratory illess. She advised that people relocate. 69 I 2006, the Iteratioal Agecy for Research o Cacer (IARC, 2006), the sciece arm of the WHO, reclassified formaldehyde as kow to cause cacer i humas (Group 1) ad specifically oted the compellig evidece of leukemia i the workplace studies. 70 I sprig 2008, the GAO released a report idetifyig iterferece by Seator Ihofe as cotributig to the delay ad complicatig the EPA s attempts to complete its assessmet of formaldehyde. The GAO also testified to this i Cogress. 71 Prevet the Agecy from fializig assessmet I Jue 2009, to prevet the EPA from fializig its assessmet, The Formaldehyde Coucil worked with Louisiaa Seator David Vitter to block the cofirmatio of Presidet Obama s omiee, Dr. Paul Aastas, to ru the EPA s Office of Research ad Developmet (locatio of the IRIS program). Seator Vitter held the omiatio hostage util the EPA agreed to sed its assessmet to the Natioal Academies for yet aother review esurig a delay of at least two years before the EPA could update its formaldehyde assessmet. 72 Iroically, Vitter s home state of Louisiaa is a place where his costituets have reported health problems sice beig housed i formaldehyde-cotamiated trailers after hurricae Katria. The formaldehyde idustry expressed its gratitude to Seator Vitter for his iterferece. 73 I the fall of 2009 IARC ad the NTP ot oly cofirmed previous determiatios that formaldehyde causes ose ad asal cavity cacer i humas, but wet further ad specified that there was sufficiet evidece likig formaldehyde 74, 75, 76,77 exposure to icreased leukemia risk i people. I Jue 2010, the EPA fially released its log-awaited draft assessmet to the public. 78 The draft assessmet idetified formaldehyde as causig cacer i the ose ad asal cavity, ad also elevatig the risk of leukemia. Importatly, it estimated that the cacer risks posed by a full lifetime ihalatio exposure to average idoor air formaldehyde levels could be as high as oe i 1,000 cacers above backgroud, approximately five-fold more carciogeic tha the old 1991 risk estimate still o IRIS. Challege the Agecy New Draft Assessmet After a 14-moth process, i April 2011 the Academies issued its review of the EPA draft assessmet. The Academies cofirmed the EPA s determiatio that formaldehyde causes cacer i humas, but recommeded that the EPA rewrite its report to more clearly commuicate the scietific reasoig uderpiig its assessmet. The Academies urged the EPA to fialize its rewritte report as soo as possible. While askig the EPA to state its reasoig more cocisely, ad to separate out leukemia risks from lymphoma risks, the Academies supported the EPA s determiatio to iclude leukemia i its calculatio of cacer risks. 79 Joseph V. Rodricks, a cosultat with Eviro who briefed the America Chemistry Coucil about the [Academies ] report, ackowledged that the pael did ot say EPA got it wrog by cocludig formaldehyde causes leukemia ad lymphoma, the trade press reported. Istead, the pael told EPA to better support its coclusio. Rodricks said he iterprets the evidece o leukemia risks as virtually oexistet. The pael s report, however, says EPA must address the topic ad hece urges EPA to do so clearly ad cosistetly, [Rodricks] said. 80 PAGE 12 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

15 Formaldehyde Timelie Formaldehyde assessmet first o-lie (EPA IRIS database) 1998 The EPA iitiates update of assessmet 2003 Natioal Cacer Istitute publishes study showig lik betwee workplace formaldehyde exposure ad leukemia 2003 Bush Admiistratio proposes to exempt plywood facilities from formaldehyde pollutio cotrols Natioal Toxicology Program pael votes to list formaldehyde as a kow huma carcioge 2009 Seator Vitter (R-LA) blocks presidetial omiee util EPA agrees to have formaldehyde assessmet reviewed FCI thaks Vitter i a press release Occupatioal Safety ad Health Admiistratio (OSHA) tightes formaldehyde workplace exposure limit Formaldehyde classified by the EPA as a probable huma carcioge Idustry scietists develop model to challege ew EPA assessmet Idustry forms the Formaldehyde Coucil, Ic (FCI) Govermet Accoutability Office (GAO) issues report documetig idustry political iterferece with IRIS program Natural Resources Defese Coucil (NRDC) wis court challege to overtur proposed rule to exempt plywood reportig 2010 America Chemistry Coucil attacks both the EPA draft assessmet ad pedig NTP Report o carcioges 2010 The EPA issues ew draft assessmet, estimatig that formaldehyde is a 5-fold more potet carcioge tha 1991 estimate PAGE 13 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

16 Attack the Redrafted Agecy Assessmet The America Chemistry Coucil (ACC, formerly called the Chemical Maufacturers Associatio), a chemical idustry trade associatio, wasted o time i usig the Natioal Academies report to attack both the EPA draft assessmet ad the NTP s assessmet of formaldehyde i its pedig Report o Carcioges. I both cases, the ACC refereced the Academies report as justificatio for its attacks. A week after the Natioal Academies report came out, ACC set a letter to EPA Admiistrator Lisa Jackso, askig that all IRIS assessmets curretly i draft form, or expected to be issued as drafts i 2011 ad 2012, be submitted for review by the Natioal Academies. 81 This request would ot oly be cost-prohibitive, sice each review by the Academies costs about three-quarters of a millio dollars, but directly cotradicts the actual recommedatios of the Academies report, which specifically said, The committee recogizes that revisio of the approach will ivolve a extesive effort by EPA staff ad others, ad it is ot recommedig that EPA delay the revisio of the formaldehyde assessmet to implemet the ew approach. 82 A week later, the ACC wrote aother letter pressurig the Departmet of Health ad Huma Services (HHS) to revise its Report o Carcioges, specifically challegig the lik with leukemia. 83 The trade press, reportig o these delay tactics, said Idustry has already seized upo the [Academies'] report i their efforts to pressure EPA ad HHS to alter their coclusios. 84 The ACC s bid was ultimately usuccessful i holdig back the Report o Carcioges. After a four year delay, the NTP issued the 12 th Report o Carcioges i Jue 2011, ad listed formaldehyde as kow to cause cacer i humas. 85 While the report ackowledged that the mechaism by which formaldehyde causes leukemia is ot well uderstood, it relied upo existig evidece: studies of workers exposed to high levels of formaldehyde, such as idustrial workers ad embalmers, foud that formaldehyde causes myeloid leukemia, ad rare cacers icludig sioasal ad asopharygeal cacer. 86 The NTP icluded a addedum with its formaldehyde assessmet that discussed the Academies review of the EPA s formaldehyde assessmet uder IRIS. The addedum made clear why the Academies critique did ot udermie or coflict with the NTP s listig of formaldehyde as a huma carcioge. Iroically, the ACC was quoted i the New York Times as rejectig the report s coclusios ad expressig cocer that politics may have hijacked the scietific process. 87 I July 2011, the EPA aouced a set of plaed chages to the IRIS program i respose to the recommedatios of the Natioal Academies pael. 88 However, sice the release of the Academies report, it is the chemical idustry that has bee workig actively to politicize the scietific process, icludig callig o the White House to assert greater cotrol over both the IRIS program ad the NTP, ad pressig for the Natioal Academies to be required to review all IRIS assessmets. I spite of all the politics ad bureaucracy, the sciece o formaldehyde has remaied steady: the EPA, the IARC, ad a expert scietific advisory committee all cocluded that the Natioal Cacer Istitute data show statistically sigificat icreased icideces of leukemia or lymphoma i workers exposed to formaldehyde. 89 The formaldehyde saga, with its years of delayed assessmets ad aggressive lobbyig by the formaldehyde idustry, demostrates the eed for clear statutory deadlies for chemical evaluatios. If deadlies are missed, cosequeces eed to be stipulated ad eforced. The 13 years of delay caused by the chemical idustry ploys o formaldehyde has likely brought them billios of dollars worth of sales, while costig the public more tha a decade of exposures to a potet carcioge, resultig i ucouted cases of cacer atiowide. PAGE 14 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

17 Case #3: Styree Styree is used to maufacture may plastics, latex paits, sythetic rubbers, polyesters ad coatigs. It is also approved for use i food-cotact materials, ad is a FDA-approved sythetic flavorig i ice cream ad cady. 90 Styree, also foud i tobacco smoke, is regulated as a Hazardous Air Pollutat by the EPA. The EPA has bee tryig to update its styree assessmet sice 1998, with o ed i sight. Approximately 4 to 5 billio pouds of styree are produced aually i the Uited States, resultig i over 20 millio pouds of waste styree, with 17.8 millio pouds emitted ito air ad 1.7 millio pouds discharged ito surface waters, accordig to the most recet data available. 91,92 Styree is listed uder the Clea Air Act as a Hazardous Air Pollutat ad is classified by the World Health Orgaizatio (WHO) chemical assessmet program, the Iteratioal Agecy for Research o Cacer (IARC) as possibly carciogeic to humas. 93 I additio, styree oxide, a major metabolite of styree, is listed by the Natioal Toxicology Program s Report o Carcioges as reasoably aticipated to be a huma carcioge. 94 Noetheless, the EPA s old assessmet of styree, which was first o-lie i 1987 ad last revised i 1993, fails to accout for styree s cacer risks; the outdated assessmet provides risk estimates for oly o-cacer effects. 95 Sposor New Studies The EPA s efforts to update the sciece o its styree hazard assessmets started i That year, the styree idustry itself voluteered to perform a updated risk assessmet of the chemical, supposedly to relieve the EPA from havig to udertake the task. 96 I a serious misstep that the EPA would evetually come to regret, the agecy accepted the styree idustry s offer. A idustry trade associatio The Styree Iformatio ad Research Ceter (SIRC) bega draftig a toxicological review of styree for the EPA. 97,98 With this review, the EPA essetially allowed idustry to parse the evidece ad reach its ow coclusios i a literature review ad scietific assessmet of styree s cacer ad o-cacer risks. SIRC was ot the oly idustry-based group workig to ifluece the EPA s styree toxicity assessmet. I 2000, PAGE 15 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

18 the Iteratioal Istitute of Sythetic Rubber Producers (IISRP), a idustry trade associatio, submitted a study to the EPA that tried to shift the blame for a observed excess i leukemia deaths amog a group of styree-butadiee rubber workers from styree to butadiee, aother hazardous chemical that is also resposible for workplace cacers ad deaths. 99 However, the fact that workers are ofte exposed to both deadly chemicals does t make either oe ay safer. I 2002 the WHO udertook its ow extesive scietific review with its IARC committee. This review cocluded that styree was possibly carciogeic to humas (Group 2B), based o limited evidece i both humas ad experimetal aimals. 100 The committee was comprised of 29 scietists, of whom three had fiacial ties to the styree idustry; two of the 29 were paid cosultats for SIRC. This coflict was brought to light i a public letter from NRDC scietists ad a letter from the former Director of IARC a iteratioallyreowed cacer expert siged by thirty promiet scietists ad chemical experts. 101,102 Followig these public revelatios of SIRC s participatio i the IARC review ad i draftig the EPA assessmet, 16 members of the Califoria Legislature asked Seator Barbara Boxer to lauch a ivestigatio ito idustry-sposored groups beig ivited by the EPA to draft EPA chemical assessmets. Styree was metioed specifically as a example of this outrageous practice. 103 Later i 2002, a styree idustry cosultat submitted to the EPA a study arguig that the cacers i lab rodets related to styree are caused by a uique cellular process that is ot likely to cause cacer i humas. 104 Idustry was agai callig out the Four Dog Defese, arguig the third dog: my dog bites, but it will ot hurt you. I 2003, SIRC submitted its draft styree assessmet to the EPA, havig take five years to complete it. However, the EPA foud that SIRC s draft assessmet was so poorly doe that it could ot be used; the agecy subsequetly aouced its itetios to abado the use of idustry first drafts altogether. EPA maagemet was eve quoted i trade press expressig frustratio with the failed program, sayig it did ot save EPA staff time or effort ad created substatial cocers about coflict of iterest. 105 I 2004, the America Composites Maufacturers Associatio (ACMA), a idustry trade orgaizatio represetig over 1000 compaies that maufacture composite materials icludig fiberglass, plastics, ad wood composites that are made with styree resi, asked the EPA to avoid causig uwarrated public cocer ad ecoomic harm whe alertig the public about styree s cacer risks. 106 ACMA, cocered that a EPA classificatio of a cacer risk will harm their idustry, estimates that 80,000 workers are exposed to styree as a result of work activities, ad that most Americas use products every day that may cotai very small residual levels of styree icludig toys ad eve some foods. 107 They are cocered that a EPA classificatio of a cacer risk will harm their idustry. I a cotiuig effort at damage cotrol, later that year SIRC opposed the omiatio of styree for iclusio i the govermet s Report o Carcioges. 108 The challege was largely based o the coclusios of a expert pael sposored by SIRC at the Harvard Ceter for Risk Aalysis. The idustry-fuded pael cocluded that the balace of epidemiologic evidece does ot suggest a causal associatio 109, 110, 111 betwee styree ad ay form of cacer i humas. SIRC also criticized the IARC cacer classificatio of styree by poitig out weakesses i the studies ad otig that idustry-sposored reaalysis foud o cacer risks. 112 Delay by Requirig the Agecy to Review New Studies I the sprig of 2011, cosultats for the styree idustry preseted the results of their ew studies at a professioal meetig of the Society of Toxicology. I a to the EPA s scietists, they claimed to have demostrated that styree ad styree oxide are both NOT toxic i mouse lugs 113 [caps i origial ] uless the chemicals are further metabolized. Oe cosultat wrote, I am ot sure where you are i the draft developmet process, but I hope you will seriously cosider these data ad the impact o a cacer evaluatio of styree mouse lug tumors. 114 Note that this argumet appears to be of questioable scietific relevace sice styree oxide, the metabolite of styree, damages DNA directly, whereas the idustry study addresses cellular damage, which does t pose ay scietific challege to the cacer risks. This is aother example of the third dog i the Four Dog Defese my dog bit you but did ot hurt you. As oted i our formaldehyde case study above, the chemical idustry ra a aggressive but ultimately usuccessful campaig to prevet the 12th Report o Carcioges from beig published by the NTP. I additio to formaldehyde, aother primary motivatio for the campaig was the listig of styree as reasoably aticipated to cause cacer i humas. 115 The fial NTP report idetified limited evidece for cacer from worker studies showig icreased risk of cacers such as leukemia ad lymphoma, some evidece of elevated cacer risks of the pacreas or esophagus amog styree workers; ad evidece from mice studies of lug cacer. PAGE 16 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

19 Attack the Agecy s assessmet Immediately after the publicatio of the Report o Carcioges, the styree idustry filed a lawsuit to have the listig withdraw. That lawsuit cotiues to be litigated. 116 Meawhile, although the EPA assessmet of styree was lauched i 1998, eve ow, 13 years later, o deadlies or milestoes have bee completed. Eve the very first step, writig the first draft of the assessmet, has ot bee completed. Therefore, at this time the 1993 assessmet, still lackig a cacer risk estimate, is the oe that is posted o the EPA s IRIS database represetig the EPA s most curret scietific estimate of styree s health risks twety years out of date. Styree Timelie Sytree assessmet first o-lie (EPA IRIS database); oral o-cacer risk 1998 Styree Idustry drafts update of the EPA s chemical assessmet 2011 Styree idustry files a legal challege to have styree withdraw from the Report o Carcioges 2004 Sytree idustry opposes listig of styree i the Report o Carcioges The EPA adds a ihalatio ocacer risk estimate to the o-lie assessmet 2002 Styree idustry fiishes its draft assessmet for the EPA, but the EPA rejects it. The Iteratioal Agecy for Research o Cacer classifies styree as possibly carciogeic to people (Group 2B) PAGE 17 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

20 Coclusios ad Recommedatios The EPA eeds the authority to protect health. Meaigful TSCA reform must take away the icetive ad rewards for the chemical idustry to play the delay game while the public pays the price. The Toxic Substaces Cotrol Act (TSCA) is i eed of serious structural reform. Ay effective system established for assessig chemicals uder TSCA will eed to iclude both eforceable deadlies for completig chemical assessmets ad meaigful cosequeces for the failure to complete a assessmet withi those deadlies. This should iclude settig default iterim health-protective stadards util the EPA ca complete assessmets, ad restrictios o the expasio or ew use of a chemical pedig completio of the assessmet. Such cosequeces will be ecessary to elimiate the chemical idustry s icetive to prevet assessmets from beig fialized, as is the curret case with the IRIS program. I this report, NRDC has documeted the attempts to assess three high-volume workhorse chemicals commoly used i our coutry: TCE, formaldehyde, ad styree. Each of these chemicals has a extesive record of hazard data ad has bee the subject of study by govermet ad ogovermetal bodies for more tha a decade. People are regularly made sick by these chemicals through household ad idustrial uses, ad may have died as result. Nevertheless, health assessmets that IRIS staff estimate should ormally take two years have dragged o for a decade or more. 117 There are scores of other chemicals that we kow cause serious health effects (cacer, eurological problems, ad reproductive harm) ad for which exposure is widespread ad commo. The atio urgetly eeds a law i place that eables the EPA to test, assess, ad regulate chemicals i a timely maer i order to protect public health ad evirometal safety. TSCA as curretly writte is ot that law. Meaigful reform must take away the icetive ad rewards for the chemical idustry to play the delay game while the public pays the price. Cogress eeds to adopt several major reforms i order to make TSCA a effective regulatory tool: Shift the burde of proof from the EPA to the chemical idustry to show that chemicals ca be used without harmig huma health or the eviromet. Establish firm ad eforceable deadlies for the EPA to complete its chemical assessmets. Reverse the presumptio of iocece, so that chemicals are presumed harmful i the absece of a assessmet. Set default iterim health-protective stadards ad restrictios o a chemical s use pedig completio of a risk assessmet. Give the EPA clear authority to obtai iformatio o chemicals, require testig, ad take actio to protect the public whe chemicals are kow to be usafe. Chemicals ca be desiged to be o-toxic or less toxic. May iovative busiesses are already patetig ad producig products that are safer for our families ad the eviromet. But eve these ew, safer chemicals ad materials will eed to be tested ad regulated. The public has the right to expect that the govermet will review the risks of chemicals ad regulate them correctly. Cogress ad the Obama admiistratio must act quickly to make the logoverdue reform of TSCA a reality. PAGE 18 The Delay Game: How the Chemical Idustry Ducks Regulatio of the Most Toxic Substaces

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