Environment Health Safety Brochure 2013

8/11/2019 Environment Health Safety Brochure 2013

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THE ENVIRONMENT,HEALTH AND SAFETY

PROGRAMME

2013-16


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THE ENVIRONMENT, HEALTH AND SAFETYPROGRAMME

2 The Organisation for Economic Co-operation and Development

3 Preface

4 OECD and the Environment

5 OECDs 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 and safety

31 Publications on the internet

32 Selected databases

33 Selected software


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The 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 nd solutions to common problems. Dialogue, consensus and peer review arefundamental elements of the OECDs work.

The OECD is one of the worlds 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 agr iculture, 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 of

things, 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 OECDs work, and the Organisation works on specic issues with many other countries.

Organisation for Economic Co-operation

and DevelopmentAustraliaAustriaBelgiumCanadaChileCzech RepublicDenmarkEstoniaFinlandFranceGermanyGreeceHungaryIceland

IrelandIsraelItaly

JapanKoreaLuxembourgMexicoNetherlandsNew ZealandNorwayPolandPortugalSlovak RepublicSloveniaSpainSwedenSwitzerland

TurkeyUnited KingdomUnited States

* M e m

b e r c o u n

t r i e s


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save OECD governments and the chemical industry at least

EUR 150 million a year.

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.

Projected chemicals production by region (in sales):Baseline, 2010-2050

Source: OECD (2012) OECD Environmental Outlook to 2050, OECD publishing, Paris.

For 40 years, the OECD has been dedicated to protecting health

and the environment by promoting chemical safety worldwide.

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.

The chemical industry is one of the worlds 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 science-based, 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 efcientand effective. These OECD activities have been estimated to

Preface

0

2 000

4 000

6 000

8 000

10 000

12 000

14 000

16 000

2010 2030 2010

RoWChinaBRIICSOECDWorld


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environmental policies that are economically efcient andenvironmentally effective.

key publication The OECD Environmental Outlook to 2050 projects

demographic 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 signicant costsof inaction, both in economic and human terms.

key link www.oecd.org/env

T he OECD Environment Programme has been workingon environmental policy issues for over 40 years andconcentrates on four work areas:

environmental reviews, indicators and outlooks climate change, biodiversity, water and waste decoupling environmental pressures from economic growth environment, health and safety.

The OECD provides advice to both OECD and partnereconomies, providing policy analysis, statistical informationand recommendations to help them develop and implement

OECD and the Environment

A healthy economy needs a healthyenvironment. In line with its missionto promote sustainable economicgrowth and rising living standards, theOECD promotes better integrationof environmental concerns intoeconomic and sectoral policies.

Angel GurraOECD Secretary-General


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By 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 of

T his 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).

Its aims are: to protect health and the environment, whileavoiding duplication of effort and ensuring that efciencies aremade and barriers to trade avoided.

A short historyThe OECD has been working on environment, health and safetysince 1971, initially focusing on specic industrial chemicalsknown to pose health or environmental problems, such asmercury or CFCs (chlorouorocarbons 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 rst time concerted international action was used tocontrol the risks of specic chemicals.

OECDs Environment, Health and SafetyProgramme


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Working together on chemical safetyOECD governments regulate chemicals based on a systemof testing to identify hazards, determining exposure andassessing risks. This system requires chemical manufacturers

to 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 efciencies 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 signicant efciencieswhile maintaining high levels of safety.

key link www.oecd.org/ehs

pesticides, biocides and products of modern biotechnology,as well as on PRTRs . In 2006 the safety of nanomaterials wasadded as a new area of activity.


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OECD Council Acts, which are international legally bindinginstruments, may be issued to support the work more formallyat a political level. Around 20 Acts deal specically withchemical safety issues and cover areas as diverse as chemicalaccidents, exchange of condential data on chemicals or thepolluter-pays pr inciple.

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.

Percent increase of savings from 1998 to 2008

Source: OECD (2010) Cutting Costs in Chemicals Management. OECD publishing, Paris.

Global Sales of Chemicals

Cost of OECD EHS Secretariat

Savings to Governments and Industry

135%

8%

164%

Savings to governments and industry

For non-clinical health and safety testing, for

example, 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.


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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 acceptance

and 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.

key link www.iomc.info

The following texts are important international references thattake into account OECD work on chemical safety:

Chapters 19 and 20 of the UNCEDs Agenda 21 adopted

in 1992 in Rio de Janeiro The OECD Environmental Strategy for the FirstDecade of the 21st Century, adopted by OECD EnvironmentalMinisters in 2001

Paragraph 23 of the Johannesburg Plan ofImplementation, adopted at the World Summit on SustainableDevelopment in 2002

Strategic Approach to International ChemicalsManagement, adopted by the International Conference onChemicals Management (ICCM) in Dubai in 2006.

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.

In 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.


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There is an ongoing need to develop new OECD Test Guidelines,or update existing ones to meet new regulatory needs, reectscientic 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/testguidelines

The 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 ammability and watersolubility), effects on human health and wildlife (such as shortand long-term toxicity), environmental fate, biocide efcacyand 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 providessufcient detail for chemicals to be tested in the same mannerin laboratories around the world.

Common policies and high-qualityinstruments for chemical safetyTesting: Developing international testing and quality standards


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inspections and study audits. It also gives governmentsguidance for ensuring international liaison.

Work continues to produce new documents to assist test

facilities 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

condence in one anothers 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-membereconomies.

key link www.oecd.org/env/glp

Good Laboratory PracticeThe OECD Principles of Good Laboratory Practice (GLP )complement the OECD Test Guidelines by setting qualitystandards for the organisation and management of test

facilities 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 laboratorys 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 submitted

to regulatory authorities, to notify or register chemicals, are ofsufcient quality and rigour and are veriable.

Like the Test Guidelines, the GLP Principles are acceptedworldwide as the quality standard for non-clinicalenvironmental health and safety testing of chemicals . Therst set of Principles was published in 1981. They were updatedin 1997 to take into account new requirements and techniquessuch as eld studies, and electronic capture and storage ofdata.

A 1989 OECD Council Decision requires governments toestablish and maintain procedures for ensuring that testfacilities have complied with the OECD GLP Principles through


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key link www.oecd.org/env/newchemicals

New chemicalsNew chemicals are chemicals that companies wish to

introduce to the market for the rst 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 new

chemicals notications among countries . Under such anapproach, countries would review and accept each others newchemical notication decisions, and companies could submitone notication and then market globally.

For the OECD, this involves working on administrativeprocedures, providing guidance on denitions of key termsand harmonisation of country notication 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.

Assessment: Increasing global assessments of chemicals


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Existing chemicalsExisting chemicals are the thousands of chemicals that wereput on the market before new chemical notication systemswere established and whose hazards have not been thoroughly

evaluated 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/hazard

Key database The OECD eChemPortal , launched in 2007, offers free

public 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. Classication results as well as exposureand use information are provided when available

key link www.oecd.org/ehs/eChemPortal


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HazardIdentification

HazardCharacterisation

EnvironmentalHazard Assessment

EnvironmentalExposure

Assessment

RiskCharacterisation

Risk Evaluation

Emission and ExposureControl

Risk Monitoring

Risk Communication

RiskAssessment

RiskManagement

Harmonising assessment methodsIn simple terms, risk to human health and the environmentposed by chemicals is determined by the equation:

hazard (chemical-specic properties that lead to

harmful 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 quantied estimates of chemical emissions fromspecic industries (for example, in the semiconductor and

microelectronics manufactur ing industries or in industrial andinstitutional laundries) or from specic 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

Flowchart on Environmental Risk Assessmentand Management of Chemicals


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Innovation: Encouraging sustainable chemistrySustainable chemistry involves the design, manufacture anduse of efcient, effective, safe and more environmentally benignchemical products and processes. This implies maximising

resource efciency through activities such as energy and non-renewable resource conservation, risk minimisation, pollutionprevention, minimisation of waste at all stages of a productslife-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. The

OECD 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

Management: Reducing chemical risksThe term risk management applies to the nal step inregulatory oversight of chemicals: how to manage the life-cycles of chemicals so that society can take advantage of their

benets while minimising their risks.

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 r isk management of specic chemicals of

concern for human health and the environment, such as PFCs(peruorinated compounds), which can be found in outdoorclothing, re-ghting 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/pfc


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(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, chemical

industry and other stakeholders in lling gaps in(eco)toxicity data needed for assessing the hazardsof chemicals. It incorporates information and toolsfrom various sources into a logical workow. Groupingchemicals into chemical categories is crucial to thisworkow.

The OECD promotes the regulatory use of various promisingnew instruments for gathering information on the safety of

chemicals and for making best use of scientic advances inchemicals management. With these tools, it becomes possibleto obtain more safety information and maintain quality whilereducing costs, time and animal testing.

Non-animal testing The 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 on

animals, 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 rene 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.

New methodologies: Working towards regulatory use


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proling (metabolomics), in combination with bioinformaticmethods and conventional toxicology.

OECDs activity on Molecular Screening and Toxicogenomics

takes 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.


Adverse 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 rst reach and then interact with aninitial target in the organism and how this molecular initiatingevent triggers a sequential series of biological activities or keyevents that ultimately culminate in a nal adverse effect in theorganism.

These 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

The seminal features of the Toolbox are:

Identication of relevant structural characteristics andpotential mechanism or mode of action of a target chemical.

Identication of other chemicals that have the samestructural characteristics and/or mechanism or mode ofaction.

Use of existing experimental data to ll data gap(s) by read-across, interpolation or extrapolation.

key link www.oecd.org/env/hazard/qsar

Toxicogenomics and molecular screening 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 metabolite

Endpoint 1

Endpoint 2

Endpoint 3

Chemical 1 Chemical 3Chemical 2 Chemical 4

read-across

extrapolation

interpolation

available experimental data data pap


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technologies as well as the development of methods to groupchemicals into chemical categories that can be programmedinto the QSAR Toolbox.


Common (electronic) formatsThe formats used by companies and governments to reportsummary results of chemical tests vary widely, making itdifcult for governments to share this information. As aresult, for every Test Guideline, the OECD has developed

corresponding 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, cross-check of data and cost saving in chemical testing.

key link www.oecd.org/ehs/templates


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The OECD promotes convergence of policies among membercountries in order to create a level playing eld in areaswhere information sharing, understanding and condence,if not harmonisation, are of great mutual benet. 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 efcient 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 Acceptance of 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 Council

Decision on Compliance with GLP ensures that compliancewith the latter is monitored by countries in a harmonised andinternationally acceptable manner.

OECD and the rest of the worldConvergence of policies and tools for managing chemicals

Key Legal Decision

The Council Decision on MAD decides that the datagenerated in the testing of chemicals in an OECD membercountry in accordance with OECD Test Guidelines and OECDPrinciples of Good Laboratory Practice shall be acceptedin other member countries for purposes of assessmentand other uses relating to the protection of man and theenvironment.


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that non-OECD economies share of world production willsurpass OECD production by 2050. As non-member economiesplay an ever-increasing role in the manufacturing of chemicals,convergence of their chemicals safety frameworks with those

of OECD countries will have economic, environmental andhealth advantages for all concerned.

OECD countries are working with non-member economies toestablish similar chemicals management systems that helpprotect the environment and human health from the risks ofchemicals, limit the time it takes for chemicals to reach themarket, minimise duplication and resources needed for testingand assessment, and avoid trade barriers.

In this context, in 2008, the OECD Council adopted a Resolutionon the Implementation of the UN Strategic Approach toInternational Chemicals Management (SAICM) . This calls forcountries to work together in OECD to ensure that, as chemicalsmanagement programmes are established or upgraded,OECD products will be accessible, relevant and useful to non-members in order to assist them in developing their capacitiesfor managing chemicals.

Together, these Council Decisions mean that new non-clinical environment, health and safety data for notication orregistration of a chemical have to be developed only once byindustry and can then be used for regulatory purposes across

OECD countries and non-OECD countries which adhere to thesystem.

MAD increases the efciency and effectiveness of chemicalnotication and registration procedures for both governmentsand industry. It ensures high-quality test data and a commonbasis of information for assessing risks to human health andthe environment, thereby facilitating government evaluationsand work sharing. MAD also helps limit the number of animals

used in testing and their suffering, and saves time and moneyfor industry by avoiding duplicative testing. The combined netsavings for governments and industry are estimated to be atleast EUR 150 mill ion a year.

Assisting non-OECD economies to managechemicalsWorking with non-member economies is increasinglyimportant for OECD.

While production in OECD countries still accounts for almost60% of the world total, production in non-OECD economies (bothdomestic companies and multinational rms), particularlyin Brazil, Russian Federation, India and China, is rapidlyincreasing. The recent OECD Environmental Outlook projects


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Thailand is now a provisional adherent to the system and morecountries are expected to join MAD in the coming years.

OECD biosafety work also increasingly involves key non-

member economies (e.g. Argentina, Brazil, China, India, Latvia,the Philippines, Russian Federation, South Africa, Thailand,African countries through NEPAD). The OECD also benetsfrom input provided by the UN Convention on BiologicalDiversity, FAO (UN Food and Agriculture Organization), WHO(UN World Health Organization) and industry representatives.

key link www.saicm.org

Participation of non-member economiesThe MAD system has been open to non-OECD economies since1997, allowing them to participate with the same rights andobligations as member countries once they have implementedthe two Council Decisions mentioned above. South Africawas the rst to participate as a full adherent to the CouncilDecisions and other full adherents now include Argentina,Brazil, India, Malaysia and Singapore.

A key international strategy on chemical safety

The 2006 UN Strategic Approach to International ChemicalsManagement (SAICM) is having an impact on national

policies in OECD and non-member economies alike. As aresult, increased efforts related to chemicals managementare required in all countries. The instruments alreadydeveloped in the OECD are being made as accessibleand useful to non-members as possible. Through thedevelopment, implementation and distribution of thesetools, countries are working together in OECD to ensurethat the chemical safety policies of OECD and non-membersconverge in view of global regulatory efciency and related

trade issues.


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New safety issues?

Nanotechnology exploits the novel attributes of materialswhen their atoms and molecules are manipulated. But couldthese different technological properties also mean thatnanomaterials are different from conventional substanceswith respect to human health and environmental safety?

In 2006, the QECD agreed to work on the implications of themanufacture and use of nanomaterials for the safety of humanhealth and the environment, addressing whether traditional

testing and assessment methods used to determine the safetyof traditional chemicals were applicable to nanomaterials.After more than six years of work, the OECD and its membercountries concluded that the approaches for the testingand assessment of chemicals are in general appropriate fornanomaterials but may have to be adopted to the specicatesof nanomaterials . There is still a need to ensure that certainTest Guidelines can be used without being adapted fornanomaterials such as those that address physical-chemicalproperties or environmental fate and ecotoxicity. Such issuesare currently being addressed at OECD.

OECD work continues to evolve in response to the safety of

emerging and converging technologies such as manufacturednanomaterials.

What are nanomaterials?Nano comes from the Greek word for dwarf. It is used inthe metric measurement system to refer to a billionth so ananometre (nm) is a billionth of a metre.

Nanotechnology is the engineering of materials at the atomic or

molecular level to produce nanomaterials. Nanotechnologistsnormally work with nanomaterials which have dimensionstypically within the range of 1-100nm. A nanometer is about1/80,000th the width of a human hair and a sheet of ofcepaper is about 100,000nm thick.

Nanomaterials are not specic to one industrial sector butappear in many, from electronics and computing, to thechemicals industry, environmental technologies, medicine,cosmetics, foods, the military and the energy sector.Nanomaterials are already used in a number of commercialapplications ranging from lotions, creams and shampoos inthe cosmetics sector to self-cleaning glass or fabrics.

Focus: Safety of manufactured nanomaterials

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Test Guidelines and the on-going work on chemical accidentsand on pesticides.

There is still much to learn to fully understand how to worksafely with some nanomaterials. However, countries arecondent that they can do this if they continue to work together.This should ensure that as the economic opportunities of thetechnology advance, the human health and environmentalsafety aspects are addressed appropriately and efciently atthe same time.

key link www.oecd.org/env/nanosafety

Much of the work is based largely on the testing of arepresentative set of manufactured nanomaterials, agreed bycountries, such as carbon nanotubes or cerium oxide or silvernanoparticles, using appropriate test methods. This testinghas helped understand the types of information on intrinsicproperties of manufactured nanomaterials that may berelevant to exposure and effects assessment.

Areas of priority for the OECDOECD aims to promote international co-operation in humanhealth and environmental safety aspects of manufacturednanomaterials, notably in six specic areas:

facilitating international co-operation on riskassessment

developing testing methods for MNs (or adaptingconventional ones, such as the OECD Test Guidelines) andevaluating the potential of alternative methods, such as in vitrotests

promoting international co-operation on riskassessment and regulatory programmes

developing guidance on exposure measurement andexposure mitigation

exploring the sustainable use of nanomaterials.

The OECD ensures that the project on nanomaterials builds onexisting OECD activities on chemical safety such as the OECD

The En ironment Health and Safet Programme 23


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OECDs activities focus on both pesticides (chemical orbiological products to protect plants, used in agricultureand related areas) and biocides (a diverse group of productsincluding disinfectants used in homes and hospitals, productsto preserve wood, products to prevent fouling on boats

and products to control insects, mice or rats in homes andindustries).

Agricultural pesticidesThe OECD helps governments to co-operate in assessing andreducing the risks of agricultural pesticides by sharing thework of pesticide registration and developing tools to monitorand minimise risk to health and the environment.

To assist countries to co-operate in the review of pesticides,the OECD has created internationally agreed formats for thetwo main documents used in registering agricultural chemicalpesticides: the dossiers of pesticide test data submitted byindustry, and the monographs containing OECD governmentsevaluation of the test data.

These agreed formats improve the quality and consistency ofpesticide reviews. They also make it easier for OECD countriesto work together and reduce the workload for industry bymaking it possible to submit similar data packages to differentcountries.

In parallel, the OECD is developing electronic tools to facilitateexchanges of pesticide data and promote work sharing amongcountries.

The OECD has developed similar dossier and monographguidance for the registration of microbials and pheromones/semiochemicals which are used as biological pesticides.

The OECD also promotes pesticide risk reduction by facilitatinginformation exchange, proposing strategic options for riskreduction and promoting international awareness for certainrisk reduction tools and measures. It has reviewed and testedseveral pesticide risk indicators that can be used to measureprogress in risk reduction. To date, the OECD has addressed

Co-operation in other areas of environment,

health and safetyImproving the safety of pesticides and biocides

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several issues related to pesticide risk reduction, includingbetter user compliance, container management and labelling,better training and education programmes, and reducingpesticide spray drift. Other risk reduction issues beingaddressed include protecting pollinators from the risks ofpesticides and ghting illegal trade of pesticides.

The OECD also deals with the issue of minor uses (i.e. a small-scale pesticide use for pest control in a low acreage cropor a small pest problem in a large acreage crop). Due to theplanned insufcient return on investment of the expendituresnecessary to get regulatory approval for minor uses, thepesticide industry is reluctant to conduct research for minor

crops and farmers lack the authorised options to control pestsand diseases. The OECD project should facilitate mechanismsthat enable international co-operation on minor use issues,including work-sharing, technical guidance on the preparationof data submissions and minimising barriers to approval ofsafe products for minor uses.

The OECD goal is also to promote sustainable pest managementstrategies and in particular strategies for the adoption and

implementation of Integrated Pest Management in agriculture.

key link www.oecd.org/env/pesticides

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BiocidesAs with agricultural pesticides, the OECD has been helpinggovernments to increase efciency in the registration ofbiocides. Facilitating the sharing of biocide data and reviewsamong governments has been a primary objective.

In addition, the OECD carries out a number of activitiesrelated to biocides testing and management. These includethe harmonisation of the testing of product efcacy toensure the validity of label claims of biocidal products suchas disinfectants or insecticides. Emission scenarios aredeveloped that estimate how much of certain biocides will getinto the environment, how long they will last and their effects.

key link www.oecd.org/env/biocides

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For more than two decades, OECD has been addressing issuesrelated to chemical accidents, a subject that concerns everyonewho works in a chemical plant, l ives near one or is involved inan emergency response. The OECD has been helping countriesnot only to prevent chemical accidents but also to respond inan appropriate manner if one occurs.

The most important achievement of the OECD work has beenthe publication of three policy guidance documents: the G uidingPrinciples for Chemical Accident Prevention, Preparedness and

Preventing and responding to chemical accidents

Response ; the Guidance on Safety Performance Indicators ; andthe Principles for Corporate Governance for Process Safety. They are intended for public authorities, industry (includingmanagement and labour) and the general public.

The OECD Guiding Principles for Chemical AccidentPrevention, Preparedness and Response describe theresponsibilities of all parties involved in the production, useand handling of hazardous chemicals. They address all aspectsof preventing and managing chemical accidents, from the



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The OECD also organises international workshops to identifyand recommend best practices for specic issues of concern,such as inter alia, environmental consequences of chemicalaccidents, training of engineers, human factors in chemicalaccidents, cost of accidents versus cost of prevention, orlessons learned from chemical accidents and incidents.

Finally, the OECD helps countries share information and learnfrom each others experiences. Current activities includemanagement of the joint OECD-EU accident reporting scheme,the collection and analysis of data on chemical accidents,including economic data, and the development of scienticmethods to establish acute exposure levels.

key link www.oecd.org/env/accidents

planning and construction of installations to operation andmaintenance, training and education, community awareness,and emergency planning and response. The Guiding Principleshave been translated into several languages. An Internetversion allows the user to navigate the document and searchby keyword and topic.

The Safety Performance Indicators serve to helpstakeholders in determining whether their implementationof the OECD Guiding Principles has led to improved safety. Itgives them tools with which they can design their own safetyperformance indicators programme. A navigable web versionallows the user to search the document and create a customised

indicator programme.

The Principles for Corporate Governance for ProcessSafety (CGPS) are mainly directed to senior managers. Theyaim to strike a balance between risk and benet by drawingattention of those at the top of industry to the need forhigh standards of corporate governance in relation to themanagement of high hazard industries. As such, it is focusedon: (i) raising the prole of process safety governance; (ii)

setting out the essential elements of corporate governancefor process safety; (iii) providing a common framework; (iv)taking some of the guesswork out of establishing CorporateGovernance Programmes; (v) providing a self-assessmenttoolkit; and (vi) providing a demonstration of commitment. ACGPS booklet has been translated into several languages.

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A key tool that governments use to provide data to the publicabout the releases and transfers of potentially hazardouschemicals and other pollutants is the Pollutant Release andTransfer Register (PRTR).

A PRTR is a database or inventory of potentially harmfulchemicals and/or pollutants released to air, water and soil, andtransferred off-site for treatment. A PRTR, which is publiclyavailable, brings together information about which pollutantsare being released, where, how much and by whom.

Communicating through Pollutant Release and Transfer Registers

PRTRs are an invaluable resource for tracking pollution trendsin industries, identifying hot spots and setting priorities forenvironmental protection. A variety of stakeholders use PRTRdata on a regular basis. PRTRs can provide valuable informationand data for industries who want to improve chemicalmanagement and environmental performance, for governmentregulators, for citizens living near industrial facilities whowant to know about potential exposure, for environmental

justice movements, for the investment community to movetowards sustainable investments and for research purposes in

academia.

OECD has developed a guidance manual to assist countries toset up PRTRs. Since 1996, when the OECD started to encouragethe development of PRTRs, the number of OECD countries withoperating PRTR systems has dramatically increased. Today,all OECD countries have an operational PRTR in place or arepreparing to establish one, and many non-member economieshave also taken concrete steps towards establishing a PRTR.

The OECD activity on PRTRs therefor mainly consists ofhelping countries to implement and their PRTRs. OECD expertscurrently work: to improve release estimation techniques fromvarious sources such as point sources and diffuse sourcesincluding releases from products; to provide guidance on the



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application, use and presentation of PRTR data; to describe therole a PRTR can play in global sustainability; and to improve thecomparability of national PRTRs by harmonizing the elementsof a PRTR system across countries.

Key database Three databases on PRTRs have been developed which

provide a global portal to PRTR information, contactpoints in OECD countries, release estimation techniquesand national PRTR data (see page 28: Selected databases).

Finally, the OECD is developing a geographic informationsystem (GIS) for the global portal to PRTR information

key link www.oecd.org/env/prtr

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The OECD has two programmes related to safety of the productsof modern biotechnology: Harmonisation of RegulatoryOversight in Biotechnology , dealing with environmental safety,and Safety of Novel Foods and Feeds , addressing human foodand animal feed safety. They both focus on one of the mostchallenging issues that countries have faced in recent years:safety of products derived from modern biotechnology.Transgenic crops are increasingly cultivated worldwide whilehuman food and animal feeds derived from them are beingmarketed. Such products have to be rigorously assessedby governments to ensure that they meet high-level safety

standards.

The main focus of the OECD work is to ensure that the types ofelements used in risk/safety assessment, as well as the methodsused to collect such information, are as similar as possibleamong countries. Both programmes identify a common baseof scientic information that may be useful in assessing thesafety of specic genetically-engineered products with respectto human food and animal feed as well as the environment.

The new biotechnology techniques now developed in additionto transgenesis (synthetic biology, omics techniques, others)should also be evaluated for their potential safety impact.

The main OECD publications are consensus documents,providing key information on major crops, trees (biology of

Reaching consensus on biosafety and food safetyplants, food/feed composition), micro-organisms, modiedcharacteristics, which member countries believe are relevantto risk and safety assessment. More than 70 consensusdocuments are now available.

An emerging issue: a publication on the biology ofAtlantic Salmon is under development. This is the rst time theOECD is addressing a genetically engineered animal species.This document will use a similar safety approach as has beenused for documents on plants.

key database BioTrack Online provides ready access to food/feed/

environment safety information for those products thathave been approved for commercialisation in membercountries. The products are listed with their basicdescription, unique identiers, and with access to theirregulatory approval texts for their use in agriculture andfood or feed processing. Biotrack Online also makes theOECD consensus documents available.

key link www.oecd.org/biotrack



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All outputs of the OECD Environment, Health and Safety Programme are available for downloading free of charge on the EHS webpage at www.oecd.org/ehs/publications. Hard copies are also available on request on a limited basis.

All publications below are available in English; some have been translated into other languages.

There are series of publications in the following areas:

Testing and Assessment

Good Laboratory Practice and Compliance and Monitoring Emission Scenario DocumentsRisk ManagementSafety of Manufactured NanomaterialsPesticidesBiocidesChemical AccidentsPollutant Release and Transfer RegistersHarmonisation of Regulatory Oversight in Biotechnology

Safety of Novel Foods and Feeds

Publications on the Internet

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eChemPortalwww.oecd.org/ehs/eChemPortal

Offers free public access to information on properties of chemicals. It allows forsimultaneous search of reports and datasets by chemical name and number and bychemical property. It provides direct access to collections of chemical hazard and riskinformation prepared for government chemical review programmes. Classicationresults as well as exposure and use information are provided when available.

Database on Research intothe Safety of ManufacturedNanomaterialswww.oecd.org/env/nanosafety/database

Includes information on research projects that address safety issues of manufacturednanomaterials. It holds details of completed, current and planned research projects onsafety, which are to be updated and managed electronically by OECD counrty delegates.

The Global Portal to PRTRInformationwww.PRTR.net

Provides free access to PRTR information and activities from countries andorganisations around the world, such as the Resource Centre for PRTR ReleaseEstimation Techniques (www.oecd.org/env/prtr/rc) and the Centre for PRTR Datapresenting national PRTR data at one Internet location (www.oecd.org/env/prtr/data).

BioTrack Onlinewww.oecd.org/biotrack

Provides ready access to food/feed/environment safety information for thosegenetically-engineered products that have been approved for commercialisation(use for crops and/or food & feed processing) in countries. It also makesthe OECD Consensus Documents available for risk and safety assessment.

Selected databases



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Selected softwareQSAR Toolboxwww.oecd.org/env/hazard/qsar

Is used by governments, chemical industry and other stakeholders in llinggaps in (eco) toxicity data needed for assessing the hazards of chemicals. Itincorporates information and tools from various sources into a logical workow.Grouping chemicals into chemical categories is crucial to this workow.

Pov and LRTP Screening Toolwww.oecd.org/env/riskassessment

Has been developed with the aim of using multimedia models for estimatingoverall persistence (Pov) and long-range transport potential (LRTP) of organicchemicals at a screening level in the context of PBTs/POPs assessments.

Environmental Risk AssessmentToolkit http://envriskassessmenttoolkit.oecd.org

Gives access to practical tools on environmental risk assessment of chemicals.It describes the general work ow of environmental risk assessment andprovides links to relevant tools developed by OECD and member countries thatcan be used in each step of the work ow. Examples are provided in the formof roadmaps that illustrate the process for specic risk assessment examples,showing the steps involved in each case and the tools which were used.

IOMC Toolbox for Decision makingin Chemicals Management http://iomctoolbox.oecd.org

Is a problem-solving tool that enables countries to identify the most appropriate andefcient national actions to address specic national problems related to chemicalsmanagement. The toolbox identies the available tools that will help the countryaddress the identied national problems or objectives. Special focus is ven toidentifying simple cost effectice solutions to national chemicals management issues.

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Moreinformation

Write to us:OECDEnvironment, Health and Safety DivisionEnvironment Directorate2, rue Andr Pascal75775 Paris Cedex 16FRANCE

Email us:[email protected]

Find us on:www.oecd.org/chemicalsafety

Subscribe to our OECDiLibrary and statistics services:www.oecdilibrary.org

Find Job Vacancies on the OECD Human Resources website at www.oecd.org/hrm .

Photo credits:Front cover: Uladzimir Bakunovich- FotoliaPage 6: Steve Cole GettyPage 11: iStockphoto - ThinkstockPage 12: gunnar3000 - Fotolia

Page 17: Adam Gault GettyPage 20: Aspireimages/Inmagine GettyPage 22: Ekaterina Shilova FotoliaPage 24: Julius Khn-Institut (JKI), Germany

Page 25: Hemera ThinkstockPage 26: Kevin Phillips - GettyPage 28: Soizick de Tilly

OECD PUBLICATIONS, 2 rue Andr-Pascal, 75775 PARIS CEDEX 16PRINTED IN FRANCE ( 00 2012 42 1) NO. 90127 2012

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THE ENVIRONMENT, HEALTH AND SAFETY PROGRAMMEwww.oecd.org/chemicalsafety