Environews | Focus - Oregon State University

Environews | Focus

Focus | Outside Looking InOutside Looking InWhen Rachel Carson tookon the task of definingenvironmental healthadvocacy in the early 1960s, she madethe business of government oversight looksimple and straightforward. “Much ofthe necessary knowledge is now available,help populate a regulatory galaxy thatextends from the humblest of municipalbailiwicks to the global economy. Nevertheless,the unfolding of this new world ofprevention and protection has been neithertidy nor consistent. The scientific communitygenerates volumes of data aboutUnderstanding the Roleof Science in RegulationDave Cutler/Images.combut we do not use it,” she wrote in her1962 book Silent Spring. “We train ecologistsin our universities and even employthem in our government agencies, butwe seldom take their advice. We allowthe chemical death rain to fall as thoughthere were no alternative, whereas in factthere are many, and our ingenuity couldsoon discover more if given opportunity.”Carson would likely be dazzled by theextent to which governments of all stripeshave since called on scientific experts topotential hazards to human health, butthe process of interpretation—resultingultimately in the development of policy—is often heavily shaped by political, economic,and even cultural interests, whichcan vary dramatically from one hazard tothe next, as well as from one jurisdictionto the next.The outcome of any regulatory deliberationcan therefore be unexpected anddownright frustrating. A given agentmight be labeled a toxic threat in oneEnvironmental Health Perspectives VOLUME 117 | NUMBER 3 | March 2009 A 105

Focus | Outside Looking Inplace while being tolerated without prejudicesomewhere else, even as the architectsof each policy looked at the very same data.That prospect might puzzle many thoughtfuland earnest observers who believe definitivescientific findings should yield equallydefinitive responses.Daniel Sarewitz recalls his early days asa Congressional Science Fellow in 1989.“The scales fell from my eyes after about aweek of being [in Washington, DC],” hesays. “When you’re a scientist working inacademia, what you see is scientists arguingabout difficult problems to try to arrive atthe truth. When you’re on the Hill, you realizewhat’s really going on is these problemsare complicated both in terms of the scienceinsist that current knowledge warrants doingsomething, while the latter point to uncertaintiesin that same knowledge as justificationfor doing less, or perhaps nothing.A Case in PointThe example of bisphenol A (BPA) hasrecently testified to the ever more intricatesubtleties of the regulatory review process.This organic compound is a buildingblock in a number of widely used polymers,including the protective coatingapplied to the inside of food cans and theplastics used to form beverage containerssuch as baby bottles. Agencies in NorthAmerica and Europe have regularly consideredthe potential health implicationseffects, it is better to be safe than sorry.And so, if no new, relevant, and compellinginformation comes forward during the publicconsultation period, it is our intention toban the importation, sale, and advertisingof polycarbonate baby bottles.”Meanwhile, in 2006, the EuropeanFood Safety Authority (EFSA), an independentrisk assessment agency under the EuropeanUnion, had conducted its own evaluationof BPA and concluded that, for thegeneral population, exposure to the chemicalwas well below the tolerable daily intake(TDI), or the highest dose that can be toleratedevery day without adverse effects. ThisTDI was based on the findings of severaltoxicity studies in rats, which together hadIt’s possible to bring many different scientific lenses—interpretations of data,choices of what data to use, what theories to use—to any given complex problem.Not surprisingly, those choices end up mapping onto value preferences andpolitical preferences.— Daniel SarewitzConsortium for Science, Policy, & Outcomesand in terms of the values. It’s possible tobring many different scientific lenses—interpretationsof data, choices of what data touse, what theories to use—to any given complexproblem. Not surprisingly, those choicesend up mapping onto value preferences andpolitical preferences.”Today Sarewitz is director of the Consortiumfor Science, Policy, & Outcomes,which, in its own words, seeks to enhancethe capacity of public policy to link scientificresearch to beneficial societal outcomes. ButSarewitz says the consortium faces resistancein moving these perspectives into open publicdebate. The difficulty, as he outlined in anarticle in the October 2004 issue of EnvironmentalScience & Policy, stems from a commondesire of both advocates and opponentsof any given regulation to invoke science tomake their respective cases. The former willof this product ever since it entered commercialuse more than 50 years ago.Although various animal modelsraised questions about specific hazards—such as altering hormonal balances inrats—regulators generally concluded thatany effect on humans was too small to yieldmeasurable effects. Canada broke with internationalconsensus in 2008, however, whenit declared BPA toxic under its 1999 CanadianEnvironment Protection Act (CEPA),which applies to activities of two key federaldepartments, Environment Canada andHealth Canada. “We have concluded thatearly development is sensitive to the effectsof bisphenol A,” stated Health MinisterTony Clement in his formal announcementof the government’s move. “Although ourscience tells us exposure levels to newbornsand infants are below the levels that causeyielded a specific NOAEL (no-observedadverse-effectlevel, or the highest dose atwhich an adverse effect is not seen).In July 2008, EFSA re-examined thesafety of BPA, focusing on the possible differencesbetween neonates and adults (inboth humans and rats) in eliminating BPAfrom the body. EFSA’s scientific panel concludedthat neonates are sufficiently capableof eliminating BPA from the body and that,because of metabolic differences, rats aremore exposed to BPA than are humans.Shortly before Canada declared BPA toxic,EFSA made a public statement contendingthat the existing body of data on BPA didnot warrant such action on its part.The U.S. Food and Drug Administration(FDA), for its part, made specific referenceto that EFSA observation and to a similarreport from the Japanese National InstituteTop to bottom: CreditA 106VOLUME 117 | NUMBER 3 | March 2009 Environmental Health Perspectives

Focus | Outside Looking InComplexity and Competing InterestsIn the view of Peter Andrée, a politicalscientist at Carleton University in Ottawa,government actors will incorporate otherfactors outside of scientific evidence intotheir decisions, regardless of how muchrespect they have for the pertinent science.In this way he explains discrepancies inbureaucratic attitudes toward recombinantbovine somatotropin (rbST, also knownas recombinant bovine growth hormone,rbGH) a synthetic version of a protein producedin the pituitary glands of cattle thatenhances milk output.The FDA sanctioned the use of rbSTacross the United States in 1993, whileHealth Canada eventually banned it inthen suggested that “the Canadian reviewersdid not interpret the study results correctlyand that there are no new scientific concernsregarding the safety of milk from cowstreated with rbGH.”For his part, Andrée regards thisexchange from a different perspective. “Mytendency is to look first towards the politicaleconomy of the issue,” he says. Morespecifically, he notes significant distinctionsbetween each country’s dairy industry. Thelarger, corporation-centered U.S. pro ducerswould welcome the prospect of getting moremilk from the same number of cows, hesays. Sentiments tended the other way inCanada, where more of those producers arefamily-run operations.impact of bovine spongiform encephalo pathy(BSE) continues to reverberate. As thousandsof animals were diagnosed with this condition,politicians initially found themselvesdefending the safety of meat, offering assurancesthat the best science of the day hadfound no implications for human health.Then, when further inquiry revealed thatBSE was caused by a strange class of misfoldedproteins called prions, many of thesesame politicians had to do a very publicabout-face, acknowledging that a link withhuman health might exist.The BSE experience has unquestionablyshaped the European outlook on environmentalhealth regulation, says Kogevinas.In particular, EU lawmakers have adoptedThe tipping point is public political concern. When you raisepublic political concern, then it seems that regulators can takeaction. If there’s no public concern and only scientific concern,it’s a different kettle of fish, unfortunately.\— Barbara McElgunnLearning Disabilities Association of Canada1999, despite the findings of an independentreview panel that there was “no biologicallyplausible reason for concern about humansafety if rbST were to be approved for sale inCanada.” That panel’s only proviso was anrbST oral toxicity study in rats that resultedin a single test animal developing an antibodyresponse at low dosage.In its 1999 Report on the Food and DrugAdministration’s Review of the Safety of RecombinantBovine Somatotropin, the FDA wrotethat “such response was consistent with thatproduced by a number of food proteins and isnot necessarily an indication of absorption ofintact rbGH. As rbGH produces significantbiological effects when injected into rats, thisstudy supported the inability of rbGH tocause significant biological effects followingoral administration even at doses 50 timesgreater than the injected dose.” The FDA“There’s a whole supply managementsystem that keeps farm sizes reasonably smalland allows them to be profitable,” explainsAndrée, adding that these producers wouldbe more likely to lobby the Canadian governmentto restrict rbST, thereby maintainingthe existing level of milk output withina protected market. Any ban would thus winfavor from an organized political constituencywhile allowing government administratorsto claim they are championing publichealth, regardless of scientific testimony thatlittle or no hazard existed.The urgency to act grows once a hazardhas actually been demonstrated, evenif the nature of the hazard is not yet fullyunderstood, says Manolis Kogevinas, an epidemiologistwith the Center for Research inEnvironmental Epidemiology in Barcelona.That has been the case in Europe, where thea critical stance toward claims associatedwith the use of genetically modified organisms(GMOs) in food and pharmaceuticalprocessing. In 1998, this ongoing suspicionthreatened to undermine an economic pillarof Switzerland, where voters were offeredthe opportunity to all but outlaw geneticresearch on plants and animals within thecountry. The defeat of this referendum wasa boon for Swiss-based drug giants such asNovartis and Hoffmann-La Roche, whichdepend heavily on their ability to engagein this kind of research. Had this measurepassed, such work and the people conductingit likely would have migrated elsewhere, hollowingout a mainstay of the Swiss economy.Nor did this 1998 decision put the matterto rest. In 2005 another referendumsuccessfully installed a five-year moratoriumon the use of GMO products in SwissTop to bottom: CreditA 108VOLUME 117 | NUMBER 3 | March 2009 Environmental Health Perspectives

Focus | Outside Looking Inagriculture. Although this latest decisiondoes not have a direct impact on laboratorywork, organizations such as the SwissBiotech Association and Swiss Trade Associationhave voiced their fears that such legislativemaneuvers will restrict the freedomof researchers, fostering an internationalperception of their nation as one that isunfriendly to scientific activity.Kogevinas concedes that the hue and cryover GMOs has no counterpart in NorthAmerica. He suggests that this distinctionreflects a more fundamental difference inthe nature of public engagement, particularlythe manner in which administrativeprocedures are executed. “In North Americayou have a much more structured andactually they are political questions, andsometimes we mix things up and try torespond to political questions using strictlyscientific criteria,” he explains. The realquestion, he says, is not whether dioxinemissions should be limited to 0.1 ng/m 3 orsome other value. Instead, he says, “the realquestion is ‘What do we do with all the residues?’The real question is whether we needa particular incinerator—or incinerators ingeneral—as a means of waste reduction.”Precautionary TalesSimilar distractions crop up in U.S. discussions,whether the participants are lookingat incinerators, stem cells, or GMOs. Whatoften sets European conclusions apart,Members of the European Union tooknote, and within two years had adopted asimilar statement as the foundation for EUenvironmental regulation. The result hasimposed the juridical equivalent of “guiltyuntil proven innocent” on any manufacturerseeking permission to introduce aproduct into the marketplace, demandingthat public protection from potential harmbe placed ahead of commercial interests.Such a requirement accounts for muchof the administrative distance that separatesEurope from the United States, accordingto John Bucher, associate director of theNational Toxicology Program (NTP), amultiagency toxicology and testing programhoused at the National Institute ofThe government asks certain questions as if they were scientificquestions, when actually they are political questions, and sometimeswe mix things up and try to respond to political questions usingstrictly scientific criteria.— Manolis KogevinasCenter for Research in Environmental EpidemiologyTop to bottom: Credittransparent system for contact with institutions,with organizations, with communities,”he says. “We have less of a traditionof that in Europe.” In fact, new rules haveopened up EU regulatory review committeemeetings that formerly provided little or nopublic access.Still, says Kogevinas, having long beenexcluded from such proceedings, manymembers of the scientific community havelittle appetite for contributing to the developmentof public policy except in the mosttechnical manner. That reluctance can playinto the strategies adopted by many policymakers, as Kogevinas discovered when hewaded into Spanish deliberations over theapproval of municipal garbage incinerators,a potential source of dioxin emissions.“The government asks certain questionsas if they were scientific questions, whenhowever, is commitment to a tenet knownas the precautionary principle.The precautionary principle—anotherway of saying “better safe than sorry”—hasbeen making its way into the regulatorypractices of governments since the 1930s.By the 1990s, major events such as the Riode Janeiro Earth Summit began casting theidea in legal language. In 1998, the Scienceand Environmental Health Networkconvened an international gathering of scientists,philosophers, lawyers, and environmentalactivists at the Johnson FoundationWingspread Conference Center in Wisconsin,yielding this succinct definition of theprinciple: “When an activity raises threats ofharm to the environment or human health,precautionary measures should be takeneven if some cause-and-effect relationshipsare not fully established scientifically.”Environmental Health Sciences. “The U.S.system has evolved around the suppositionthat the government is responsible for providinginformation, or utilizing and actingon information supplied by industry, thatwould suggest that a particular chemicalshouldn’t be used in commerce,” he says.In other words, precaution is not imposedupon commercial interests as a default position;instead, hazards and risks are definedby government on a case-by-case basis.Bucher suggests that although regulatoryagencies evaluate the risks of agents fairlyuniformly, they may pay more attention tocases that rise to political or social prominence.Nor can he and his colleagues in theNTP sway this tendency, since they lackthe mandate of a regulatory agency andcannot define or assess risk as part of theirobservations. “So we must couch things inEnvironmental Health Perspectives VOLUME 117 | NUMBER 3 | March 2009 A 109

Focus | Outside Looking Interms of whether we have concerns over aparticular level of human exposure that’sgoing on in the population,” he says. “Wedo however, select agents for evaluationthrough our programs . . . that we feel warrantregulatory agency consideration.”The precautionary approach in the UnitedStates has been further stalled by a modestrider added to a congressional spendingbill in 2001—two sentences with no officialname but known alternately as the InformationQuality Act or the Data QualityAct. This seemingly minor legislation hasbecome contentious for requiring federalagencies to optimize the “quality, objectivity,utility, and integrity” of the informationsupporting regulatory activities.considered reliable for regulatory purposes,”argued members of the Center for RegulatoryEffectiveness (CRE) in correspondencepublished in the January 2004 issue of EHP.A self-styled regulatory watchdog, the CREapplauded the introduction of the legislationas a brake against an overzealous embrace ofpreliminary or incomplete research findings.That said, the precautionary principle isnot altogether absent from U.S. regulations.In 2000, the FDA submitted a paper on itsnational food safety system to the Organisationfor Economic Co-operation and Development,complete with an annex illustratingthe role that precaution plays in the system.This document outlined various adjustmentfactors that would be applied to account forwrote in the 20 January 2009 edition of theVancouver newspaper The Province. “Sensibleregulations should evaluate the risks posedby chemicals to humans and the environmentbased on sound scientific evidence.Regulators shouldn’t be solely concerned withwhether a pesticide is hazardous in the lab.Most important is how the pesticide is usedand how diluted the active ingredient is.”Observers such as McElgunn take anotherview. “Dilution of toxicants is not a solution,even when all the science is in and we have aNOAEL for sensitive end points,” she says.“Others would argue that sound scientificevidence should include both low-dose testingto uncover endocrine effects and neurodevelopmentaleffects, and cumulative assessmentsWhen an activity raises threats of harm to the environment orhuman health, precautionary measures should be taken even ifsome cause-and-effect relationships are not fully establishedscientifically.— Wingspread Statement on the Precautionary PrincipleJanuary 1998Critics have highlighted this stipulationas a loophole for corporations to hold upthe implementation of restrictions on theirproducts. For Chris Mooney, author of the2005 book The Republican War on Science,this move represented “an unprecedented andcumbersome process by which governmentagencies must field complaints over the data,studies, and reports they release to the public.It is a science abuser’s dream come true.”On the other hand, when the EPA consideredthe endocrine-disrupting potential of theherbicide atrazine in 2003, the Data QualityAct was invoked to clarify the experimentalmethods that were being used to argue thatsuch effects from this agent had been observedin frogs. “Publication of a research article in apeer-reviewed scientific journal does not meanthat the research has been accepted as valid bythe scientific community and that it should beprospects such as sensitive subgroups withina tested population, extrapolation from shorttermstudy data to assess chronic effects,extrapolation from animal data to humanapplication, and variations within a humanpopulation, such as age or sex.Still, the enforcement of precaution canraise new challenges that scientists do not yetknow how to meet. Early in 2009, the EuropeanParliament was putting the finishingtouches on regulations banning chemicalsthat go into some of the world’s most widelyused pesticides. Richard Tren, director ofthe nonprofit organization Africa FightingMalaria, insists that the ban will promptmany nations on that continent to abandontheir use of pesticides that are effectively andsafely managing a public health scourge.“This is a victory for the environmentallobby and a defeat of sound science,” heof substances that have similar properties orthat produce similar adverse effects.”For her part, Rachel Carson did not dismissthe use of chemical products, only theirindiscriminate use—and she charged policymakers with the responsibility to discriminate.But weighing the scientific evidence infulfillment of that responsibility is no simpletask. According to Sarewitz, policy makersmust deal with the harsh reality that there isnot always one best way to use chemical compounds,which is why it can be so difficultto identify and eliminate toxicants. “We’revery glib about how easy that task is,” he says,“both in terms of the question of identifyingwhat things do and the costs and consequencesof getting rid of stuff.”Tim LougheedA 110VOLUME 117 | NUMBER 3 | March 2009 Environmental Health Perspectives