The Environment, Health And Safety Programme - Oecd
THE ENVIRONMENT,HEALTH AND SAFETYPROGRAMME2013-16
THE ENVIRONMENT, HEALTH AND SAFETYPROGRAMME2The Organisation for Economic Co-operation and Development3Preface4OECD and the Environment5OECD’s Environment, Health and Safety Programme9Common policies and high-quality instruments for chemical safety18OECD and the rest of the world21Focus: Safety of manufactured nanomaterials23Co-operation in other areas of environment, health and safety31Publications on the internet32Selected databases33Selected software
2*M e mbe r countr ie sOrganisation for Economic Co-operationand ourgCanadaMexicoChileNetherlandsCzech RepublicNew anceSlovak landSwitzerlandIrelandTurkeyIsraelUnited KingdomItalyUnited StatesThe OECD is an intergovernmental organisation whose mission is to promote policies thatwill improve the economic and social well-being of people around the world. It groups34 member countries committed to democratic government and the market economy. Itprovides a forum where governments can work together to share experiences, identify goodpractices and find solutions to common problems. Dialogue, consensus and peer review arefundamental elements of the OECD’s work.The OECD is one of the world’s largest and most reliable sources of comparable statistical,economic and social data. It monitors trends, collects data, analyses and forecasts economicdevelopment, and investigates evolving patterns in a broad range of public policy areassuch as agriculture, development co-operation, education, employment, taxation and trade,science, technology, industry and innovation, in addition to environment.Using this data, the OECD works with governments to understand what drives economic,social and environmental change. It also sets international standards on a wide range ofthings, from agriculture and tax to the safety of chemicals. Above all, drawing on facts andreal-life experience, the OECD recommends policies designed to make the lives of ordinarypeople better.The OECD partners are in accession talks with the Russian Federation. Brazil, China, India, Indonesia and South Africa participatein the OECD’s work, and the Organisation works on specific issues with many other countries. OECD 2013
The Environment, Health and Safety ProgrammePrefaceFor 40 years, the OECD has been dedicated to protecting healthand the environment by promoting chemical safety worldwide.save OECD governments and the chemical industry at leastEUR 150 million a year.Modern life without chemicals would be inconceivable;chemicals are part of our daily life, from paints and insect sprayto computers, kitchen appliances, medicines or sun cream.New challenges are ahead for the OECD. Some deal with theemergence of new products, such as nanomaterials for whichthe OECD is leading the international effort on their safety.Another challenge is the rapid expansion of the chemicalsindustry in non-member economies, which increases thepotential for risks and hightens the need for co-operation. TheOECD aims to work more closely with non-member economiesand all partners worldwide to create synergies and facilitatethe sound management of chemicals.The chemical industry is one of the world’s largest, withproducts worth more than EUR 4 000 billion annually. OECDcountries account for about 60% of global chemical production.Their governments and the chemical industry therefore havea major responsibility to ensure that chemicals are producedand used as safely as possible.The OECD has been helping its member governments todevelop and implement high-quality chemicals managementpolicies and instruments. These countries now have sciencebased, rigorous and comprehensive systems for assessing andmanaging the risks of chemicals. But implementation of suchregulatory systems can be time-consuming and expensive.Therefore OECD countries work together to combine theirskills and knowledge, avoid duplication of testing, minimisenon-tariff distortions to trade and ultimately be more efficientand effective. These OECD activities have been estimated toProjected chemicals production by region (in sales):Baseline, 2010-205020302010201016 00014 00012 00010 0008 0006 0004 0002 0000WorldOECDBRIICSChinaRoWSource: OECD (2012) OECD Environmental Outlook to 2050, OECD publishing, Paris. OECD 20133
4OECD and the Environmenthealthy economy needs a healthy“ Aenvironment.In line with its missionto promote sustainable economicgrowth and rising living standards, theOECD promotes better integrationof environmental concerns intoeconomic and sectoral policies.Angel GurríaOECD Secretary-GeneralT”he OECD Environment Programme has been workingon environmental policy issues for over 40 years andconcentrates on four work areas:environmental reviews, indicators and outlooksclimate change, biodiversity, water and wastedecoupling environmental pressures from economic growthenvironment, health and safety.environmental policies that are economically efficient andenvironmentally effective.key publication The OECD Environmental Outlook to 2050 projectsdemographic and economic trends over the next fourdecades and assesses the impacts of these trendson the environment if more ambitious policies tobetter manage natural assets are not introduced. Italso examines some of the policies that could changethat picture for the better. This Outlook focuses onfour urgent areas: climate change, biodiversity, waterand the health impacts of pollution. It concludes thaturgent action is needed now to avoid significant costsof inaction, both in economic and human terms.key link www.oecd.org/envThe OECD provides advice to both OECD and partnereconomies, providing policy analysis, statistical informationand recommendations to help them develop and implement OECD 2013
The Environment, Health and Safety ProgrammeOECD’s Environment, Health and SafetyProgrammeThis programme deals with the safe use of industrialchemicals, nanomaterials, pesticides, biocides, and novelfoods and feeds. It also addresses related areas of concern andinterest, such as chemical accidents and Pollutant Release andTransfer Registers (PRTRs).It’s aims are: to protect health and the environment, whileavoiding duplication of effort and ensuring that efficiencies aremade and barriers to trade avoided.A short historyThe OECD has been working on environment, health and safetysince 1971, initially focusing on specific industrial chemicalsknown to pose health or environmental problems, such asmercury or CFCs (chlorofluorocarbons responsible for depletingthe ozone layer). The purpose was to share information aboutthe risks of these chemicals and to act jointly to reduce them.One of the important achievements of the early years was the1973 OECD Council Decision to restrict the use of PCBs. Thiswas the first time concerted international action was used tocontrol the risks of specific chemicals. OECD 2013By the mid-1970s, however, it became clear that concentratingon a few chemicals at a time would not be enough to protecthuman health and the environment. With thousands of newchemical products entering the global market every year, OECDcountries agreed that a more comprehensive strategy wasneeded. The OECD therefore began developing harmonised,common tools that countries could use to test and assessthe risks of new chemicals before they were manufacturedand marketed. This led to a system of mutual acceptance ofchemical safety data among OECD countries, a crucial steptowards international harmonisation and reduction of tradebarriers.During the 1980s, the OECD launched new projects to developmethods for risk assessment, approaches to risk management,and principles for chemical accident prevention, preparednessand response. To complement the work on new chemicals,member countries began a systematic investigation of highproduction volume “existing” chemicals that had been placedon the market before safety evaluations for new chemicalswere required. In the 1990s, new work began on the safety of5
6pesticides, biocides and products of modern biotechnology,as well as on PRTRs. In 2006 the safety of nanomaterials wasadded as a new area of activity.Working together on chemical safetyOECD governments regulate chemicals based on a systemof testing to identify hazards, determining exposure andassessing risks. This system requires chemical manufacturersto carry out a battery of tests in order to determine howindividual chemicals might affect human health and theenvironment. Governments then evaluate the test resultsand potential exposure in order to decide how each chemicalshould be managed. The advantage of this system is that it isrigorous and comprehensive. But it is very resource intensiveand time-consuming for both governments and industry.In order to achieve its twin objectives of protecting humanhealth and the environment and making efficiencies forgovernments and industry, the OECD has developed highquality common policies and instruments (further describedin the next section), that form the frameworks for co-operationand work sharing among countries. These frameworks helpgovernments and industry achieve significant efficiencieswhile maintaining high levels of safety.key link www.oecd.org/ehs OECD 2013
The Environment, Health and Safety ProgrammeSavings to governments and industryFor non-clinical health and safety testing, forexample, the results of studies done in one OECDcountry must be accepted by the others as long asthey follow the OECD Test Guidelines and Principlesof Good Laboratory Practice. This saves the chemicalsindustry expensive duplicate tests, allows countriesto “work share” and reduces the number of animalsneeded for testing. All total, OECD estimates thatthis approach saves governments and industryabout EUR 150 million each year. Despite minimalgrowth in the budget of the OECD Environment,Health and Safety Programme in recent years, thesavings to governments and industry continue togrow, as does the size of the chemicals industry.Percent increase of savings from 1998 to 2008164%135%Global Sales of ChemicalsCost of OECD EHS SecretariatSavings to Governments and Industry8%Source: OECD (2010) Cutting Costs in Chemicals Management. OECD publishing, Paris.The foundations of OECD work on chemicalsThe OECD work draws on the common interests and valuesthat member countries share because they often face the samedomestic problems. OECD 2013OECD Council Acts, which are international legally bindinginstruments, may be issued to support the work more formallyat a political level. Around 20 Acts deal specifically withchemical safety issues and cover areas as diverse as chemicalaccidents, exchange of confidential data on chemicals or thepolluter-pays principle.7
8The following texts are important international references thattake into account OECD work on chemical safety:Chapters 19 and 20 of the UNCED’s Agenda 21 adoptedin 1992 in Rio de JaneiroThe OECD Environmental Strategy for the FirstDecade of the 21st Century, adopted by OECD EnvironmentalMinisters in 2001Paragraph 23 of the Johannesburg Plan ofImplementation, adopted at the World Summit on SustainableDevelopment in 2002Strategic Approach to International ChemicalsManagement, adopted by the International Conference onChemicals Management (ICCM) in Dubai in 2006.In addition, experts from industry, academia, labour,environmental and animal welfare organisations, and severalpartner economies participate in projects and meetings. Theparticipation of all these stakeholders ensures the acceptanceand use of the products developed and agreed on in OECD.The OECD also co-operates closely with other internationalorganisations, most notably the eight other UN organisationsinvolved in chemical safety, through the Inter-organizationProgramme for the Sound Management of Chemicals (IOMC,www.iomc.info) towards in the implementation of the StrategicApproach to International Chemicals Management (SAICM,www.saicm.org) which bring together governments from morethan 150 countries and many stakeholders.CollaborationOECD work on chemicals takes places on various levels.An international team of about 30 experts in the variousdisciplines dealing with chemical safety, e.g. biology, chemistry,toxicology and also economics or statistics, work together atOECD Headquarters in Paris.key link www.iomc.infoIn member countries, OECD government representatives fromvarious ministries or agencies (health, labour, environment,agriculture, etc.) work on OECD projects at the national level.These key policy and technical experts all meet regularly inOECD meetings, workshops or fora. OECD 2013
The Environment, Health and Safety ProgrammeCommon policies and high-qualityinstruments for chemical safetyTesting: Developing international testing and quality standardsThe OECD Test GuidelinesSince 1981, the OECD has been developing the OECDGuidelines for the Testing of Chemicals, a collection of morethan 150 harmonised test methods for determining physicaland chemical properties (such as flammability and watersolubility), effects on human health and wildlife (such as shortand long-term toxicity), environmental fate, biocide efficacyand pesticide residue chemistry. Test Guidelines are preparedusing expertise from governments, academia, industry andother non-governmental organisations such as environmentalorganisations and the animal welfare community.The OECD Test Guidelines are recognised internationally asthe standards for non-clinical environment and health safetytesting of chemicals and chemical products. They are anintegral part of the Council Decision on the Mutual Acceptanceof Data (see page 18) and are used to support chemical safetyregulations in many countries. Each Test Guideline providessufficient detail for chemicals to be tested in the same mannerin laboratories around the world. OECD 2013There is an ongoing need to develop new OECD Test Guidelines,or update existing ones to meet new regulatory needs, reflectscientific progress, improve the cost-effectiveness of methods,and reduce the number and suffering of test animals. Over thelast few years, the OECD has been particularly active in thedevelopment of non-animal and alternative test methods. Inaddition, there has been considerable activity to develop testmethods to detect endocrine disrupters (chemicals that haveeffects on hormone systems of humans and wildlife).Test Guidelines are available free of charge on the publicwebsite. Draft Test Guidelines and guidance documents areavailable on the OECD website and the public is invited tocomment on these drafts.key link www.oecd.org/env/testguidelines9
10Good Laboratory PracticeThe OECD Principles of Good Laboratory Practice (GLP)complement the OECD Test Guidelines by setting qualitystandards for the organisation and management of testfacilities and for performing and reporting studies. ThePrinciples are an integral part of the Council Decision onMutual Acceptance of Data (see page 18). The GLP Principlescover all aspects of a laboratory’s daily activity, such as thelayout of testing and storage areas to prevent contamination,cleaning and calibration of equipment, handling of testanimals, and recording and archiving of test results.The GLP Principles thereby help ensure that studies submittedto regulatory authorities, to notify or register chemicals, are ofsufficient quality and rigour and are verifiable.Like the Test Guidelines, the GLP Principles are acceptedworldwide as the quality standard for non-clinicalenvironmental health and safety testing of chemicals. Thefirst set of Principles was published in 1981. They were updatedin 1997 to take into account new requirements and techniquesinspections and study audits. It also gives governmentsguidance for ensuring international liaison.Work continues to produce new documents to assist testfacilities interpret and apply the GLP Principles and to provideguidance to government authorities who inspect test facilitiesand audit studies, in order to help them monitor compliancewith the OECD GLP Principles.The OECD works with the heads of GLP inspectorates in OECDand certain non-member economies, and they meet regularlyto discuss compliance issues. This process strengthensinternational ties and builds inspectors’ and governments’confidence in one another’s monitoring systems. A continuingprogramme of peer reviews of national compliance monitoringprocedures ensures harmonisation in the way test facilities areinspected worldwide. To expand the use of the GLP Principlesand compliance monitoring procedures on an internationallyharmonised basis, the OECD also undertakes activities suchas training courses for inspectors, workshops to develop thevarious guidance documents and outreach to non-membersuch as field studies, and electronic capture and storage ofdata.economies.A 1989 OECD Council Decision requires governments toestablish and maintain procedures for ensuring that testfacilities have complied with the OECD GLP Principles throughkey link www.oecd.org/env/glp OECD 2013
The Environment, Health and Safety ProgrammeAssessment: Increasing global assessments of chemicalsNew chemicals“New chemicals” are chemicals that companies wish tointroduce to the market for the first time. Since many newchemicals will be marketed in more than one country, andeach government reviews much the same information,governments and industry work together with the OECD toreduce duplication of work and animal testing, speed up newproduct introduction to markets and reduce non-tariff tradebarriers due to different systems for managing new chemicals.The ultimate objective is the mutual acceptance of newchemicals notifications among countries. Under such anapproach, countries would review and accept each others’ newchemical notification decisions, and companies could submitone notification and then market globally.For the OECD, this involves working on administrativeprocedures, providing guidance on definitions of key termsand harmonisation of country notification exemptions, andreducing requirements for some chemical groups (such aspolymers of low concern). Also, the OECD Clearing House onNew Chemicals is developing and implementing work sharingarrangements in which companies can notify new chemicals tomultiple jurisdictions and governments can share informationwhen conducting their reviews. OECD 2013key link www.oecd.org/env/newchemicals11
12Existing chemicals“Existing chemicals” are the thousands of chemicals that wereput on the market before new chemical notification systemswere established and whose hazards have not been thoroughlyevaluated by governments. In this OECD activity, industry andgovernments gather (or generate) data on a chemical and carryout a co-operative initial hazard assessment. Governmentsand stakeholders then participate in a meeting where thesehazard assessments are agreed.key link www.oecd.org/env/hazardKey database The OECD eChemPortal, launched in 2007, offers freepublic access to information on chemical propertiesand hazards of chemicals. It allows for simultaneoussearch of reports and datasets by chemical name andnumber and by chemical property. It provides directaccess to collections of chemical hazard and riskinformation prepared for government chemical reviewprogrammes. Classification results as well as exposureand use information are provided when availablekey link www.oecd.org/ehs/eChemPortal OECD 2013
The Environment, Health and Safety ProgrammeHarmonising assessment methodsIn simple terms, risk to human health and the environmentposed by chemicals is determined by the equation:“hazard” (chemical-specific properties that lead toharmful effects) x “exposure” to chemicals (amount ofhuman intake or environmental concentration)The OECD assists countries in developing and harmonisingmethods for assessing such risk, including methodologies forhazard and exposure assessment.The OECD develops documents on emission scenariosthat give quantified estimates of chemical emissions fromspecific industries (for example, in the semiconductor andmicroelectronics manufacturing industries or in industrial andinstitutional laundries) or from specific uses. The scenariosdescribe releases of a chemical into water, air, soil and/orwaste, during different life stages such as production, use anddisposal.OECD has also developed an interactive environmental riskassessment toolkit that gives access to practical tools onenvironmental risk assessment of chemicals (see page 33:Selected software).key links www.oecd.org/env/riskassessment http://envriskassessmenttoolkit.oecd.org OECD 2013Flowchart on Environmental Risk Assessmentand Management of ChemicalsHazardIdentificationEnvironmentalHazard k EvaluationEmission and ExposureControlRisk MonitoringRisk CommunicationRiskManagement13
14Management: Reducing chemical risksInnovation: Encouraging sustainable chemistryThe term “risk management” applies to the final step inregulatory oversight of chemicals: how to manage the lifecycles of chemicals so that society can take advantage of theirbenefits while minimising their risks.Sustainable chemistry involves the design, manufacture anduse of efficient, effective, safe and more environmentally benignchemical products and processes. This implies maximisingresource efficiency through activities such as energy and non-The OECD develops tools to support the efforts of governmentand industry to manage and reduce risks posed by chemicals,and, when appropriate, to harmonise risk managementactivities on particular chemicals. The OECD also encouragesexchange of information and experiences on useful policiesand practical tools. For example, the OECD currently focuses onassisting countries in risk management of specific chemicals ofconcern for human health and the environment, such as PFCs(perfluorinated compounds), which can be found in outdoorclothing, fire-fighting foams and various surface coatings.The OECD recognises the global nature of the problems posedby these pollutants and has teamed up with UNEP to engagenon-member economies that are major producers and users ofthese chemicals in risk management activities.key link www.oecd.org/ehs/pfcrenewable resource conservation, risk minimisation, pollutionprevention, minimisation of waste at all stages of a product’slife-cycle, and the development of products that are durableand can be reused and recycled.The OECD promotes the exchange of information related toresearch and development in order to help governments supportthe development of inherently safer chemical products. TheOECD has also developed an Internet Platform for informationexchange and review of new developments and incentives forsustainable chemistry and analysed the role of environmentallegislation and innovation in promoting sustainable chemistry.A new project has been launched to promote the use of toolsand approaches that can support industry and regulators intheir efforts to substitute harmful chemicals.key link www.oecd.org/env/riskmanagement OECD 2013
The Environment, Health and Safety ProgrammeNew methodologies: Working towards regulatory useThe OECD promotes the regulatory use of various promisingnew instruments for gathering information on the safety ofchemicals and for making best use of scientific advances inchemicals management. With these tools, it becomes possibleto obtain more safety information and maintain quality whilereducing costs, time and animal testing.Non-animal testingThe OECD is committed to reducing or avoiding animal sufferingand limiting the number of test animals used. Many of thecurrent OECD Test Guidelines are based on tests conducted onanimals, with clear guidance to minimise pain and sufferingin the animals during testing. The OECD is actively workingtowards the development of methods to replace animaltests where possible, or to refine existing tests to reduce thenumber of animals used and minimise suffering. A number ofOECD Test Guidelines are already based on non- animal tests,including but not limited to skin corrosion, phototoxicity andskin absorption, eye corrosion, genotoxicity and endocrinedisruption. As new tests which meet the regulatory safetyrequirements of the OECD member countries are developedand validated, the range of non-animal Test Guidelinesavailable will increase. OECD 2013(Q)SARs(Quantitative) Structure-Activity Relationships [(Q)SARs] aremethods involving computer simulations which estimateproperties of a chemical from its molecular structure. Whilethe use of (Q)SARs in chemicals regulation is still relativelylimited, the OECD is looking at how these approaches can beimplemented in member countries.key software The QSAR Toolbox is used by governments, chemicalindustry and other stakeholders in filling gaps in(eco)toxicity data needed for assessing the hazardsof chemicals. It incorporates information and toolsfrom various sources into a logical workflow. Groupingchemicals into chemical categories is crucial to thisworkflow.15
16The seminal features of the Toolbox are:profiling (metabolomics), in combination with bioinformaticmethods and conventional toxicology.Identification of relevant structural characteristics andpotential mechanism or mode of action of a target chemical.Identification of other chemicals that have the samestructural characteristics and/or mechanism or mode ofaction.Use of existing experimental data to fill data gap(s) by readacross, interpolation or extrapolation.Chemical 1 Chemical 2 Chemical 3 Chemical 4Endpoint 1read-acrossEndpoint 2interpolationEndpoint 3extrapolationavailable experimental datadata papkey link www.oecd.org/env/hazard/qsarOECD’s activity on Molecular Screening and Toxicogenomicstakes stock of advances made worldwide on omics tools (e.g.the US ToxCast Programme) to establish long term strategiesfor rationally and economically prioritising chemicals forfurther evaluation.key link www.oecd.org/env/testguidelinesAdverse Outcome PathwaysTo facilitate the development of the novel methods outlinedabove and to promote their regulatory use, OECD has launchedan activity to improve the mechanistic understanding of howchemicals interact with living organisms. The OECD developsadverse outcome pathway which describe how a chemical orgroup of chemicals can first reach and then interact with aninitial target in the organism and how this molecular initiatingToxicogenomics and molecular screeningevent triggers a sequential series of biological activities or keyevents that ultimately culminate in a final adverse effect in theorganism.Toxicogenomics is the study of the response of a genome tohazardous substances and uses “omics” technologies such asgenomic-scale mRNA expression (transcriptomics), cell andtissue-wide protein expression (proteomics), and metaboliteThese adverse outcome pathways will inform the developmentof new Test Guidelines for key events (e.g. based on in vitrotest methods), the interpretation of results from “omics” OECD 2013
The Environment, Health and Safety Programmetechnologies as well as the development of methods to groupchemicals into chemical categories that can be programmedinto the QSAR Toolbox.key link www.oecd.org/env/testguidelinesCommon (electronic) formatsThe formats used by companies and governments to reportsummary results of chemical tests vary widely, making itdifficult for governments to share this information. As aresult, for every Test Guideline, the OECD has developedcorresponding “harmonised templates” which constitute aguide for structuring data when reporting summaries of theresults from those tests. OECD has also created commonelectronic data export/import formats for these templates tofacilitate the exchange of such information across computersystems, as increasingly needed for meta-analyses, crosscheck of data and cost saving in chemical testing.key link www.oecd.org/ehs/templates OECD 201317
18OECD and the rest of the worldConvergence of policies and tools for managing chemicalsThe OECD promotes convergence of policies among membercountries in order to create a level playing field in areaswhere information sharing, understanding and confidence,if not harmonisation, are of great mutual benefit. OECD alsoaddresses the new challenges of globalisation by making itsmaterial accessible and useful to non-member economieswhich are establishing their own chemicals managementframework.For the last four decades the role of OECD has been to assistmember countries to meet the aims of developing andimplementing policies and high-quality instruments toprotect human health and the environment, and to make theirchemicals management systems and processes as efficient aspossible. While trying to eliminate duplication of work as faras possible and avoid non-tariff barriers to trade, emphasis hasbeen on developing frameworks for work sharing in gatheringand assessing information on the potential risks of chemicalsand chemical production. The MAD system is a foundation forharmonisation of chemicals management policies throughoutOECD.MAD: Mutual Acceptance of DataThe 1981 OECD Council Decision on the Mutual Acceptanceof Data (MAD ) is the cornerstone for the system of standardsrepresented by the OECD Test Guidelines and GLP Principles(see pages 9 & 10). This Council Decision requires OECDcountries to accept test data developed for regulatory purposesin another country if these data were developed in accordancewith the Test Guidelines and GLP Principles. The 1989 CouncilDecision on Compliance with GLP ensures that compliancewith the latter is monitored by countries in a harmonised andinternationally acceptable manner.Key Legal DecisionThe Council Decision on MAD “decides that the datagenerated in the testing of chemica
THE ENVIRONMENT, HEALTH AND SAFETY PROGRAMME 2 The Organisation for Economic Co-operation and Development 3 Preface 4 OECD and the Environment 5 OECD's Environment, Health and Safety Programme 9 Common policies and high-quality instruments for chemical safety 18 OECD and the rest of the world 21 Focus: Safety of manufactured nanomaterials 23 Co-operation in other areas of environment, health .
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