Environmental Ris k Assessment - App roac hes, experiences and information sources

Environmental Ris k Assessment - App roac hes, experiences and information sources

T h e mission of the European Environment Age ncy (EEA) is "to pro vide the Com mu nity and th e Member States with objective. reliable and com para ble informa- lion at the Europe an level", Amon g the differ- e nt go als. the EEA sha ll provide infor matio n for environmental policy development and implementation and ensure broad dissemina- tion and accessibility. Impo rtant principles in th is context are: pooling of exist ing inform a- tion and know how and facilitating harmonisa- tion of data .

This is the general background to this product on Environmental Risk Assessment produced by the Monitoring and Assessm e nt Resear c h Centre at King's College. London. UK Th e primar y object ive of the work ha s been to increase the accessi bility

(0

approaches. expe- riences and informa tion sources to this exten - sive area. Althou gh, the focus of this book is on chemicals. the topic of risk assessment is chosen because of its importance for policy developme nt and implem ent ati on , demon- strate d in the wor k with radiation.chemicals.

accid ent s. cons ume r products. food and gen e modified or g-anisms (GMOs). Th e managing of the human risks has an espe cially long tradi- tion. but th e re is now an evolving inter est to apply the concept on ecological effects. In the developm e nt of environmental management systems and tools as a basis for dec ision making (expressed in th e work with ISO 14

(00).

env ironmental risk asse ssm ent can also be see n as a suppleme nt to finan cial risk assessment. Age nda 21 also re cogni ses risk assessment as an impo rta nt tool to improve the environment.

Environmental risk asse ssm ent within the broader con cep t of risk manag em ent is not an undisp uted concept. Th e case studies described in the book dearly demonstrate the opinions about environmental risk assessment bet wee n different actors on the e nvir onme nta l sce ne, such as indust ry . NGOs . authorities and the g eneral publi c. Asse ssi ng. manag ing and comm unicating th e risk s of endocrine dis- ruptor s, BSE a nd dumping the Brent Spar ar c only a fe w rec ent ex am ples.

Th e inte rpretations of the word "ris k" as a positive or negative pro bability or a conse- q uen ce reinforce the different percept ions in dis cu ssing risks .

The ma in adva ntages of risk assessm en t are the encourageme nt to use scientific data and competence as a basis for decision making.

and in that process , discri minating betwee n sc ientific fact s (as far as poss ible) a nd values.

In this contex t. this ambition is ver y close to the mandat e of the Agen cy.

Th e re are howe ve r many drawback s that are . or should be . addressed in development work co ncerning for example .Isee section Ill) :

Environmental risk assessment

• Har moni sati on of ris k assessme nt method s,

• filling the gap of data de ficien cies.

• harmonisation of test protocols for chemicals.

• under stan ding of mixtu res or multip le strcssors.

• improvement of exposure ass es sment.

• inte rnat ionally harrncnised as sessment fact ors.

• speeding up risk a sse ssmen ts. and

• tak ing into acco unt se nsitive groups.

Environmental risk management

• Explicit methodologies for risk

management.

• increased transparency of decision-making,

• peer-review of risk management assessments, and

• increased participation in risk management.

This need of deve lopment work and uncertain- ties in connection

with

risk assessment (espe- cially concerning "new'' agents, like

000-

assessed chemicals or GMOs) , must not delay the implementation work reducing the use of chemicals or other exposures. TIle precau- tionary principle is of uttermost importance for risk assessment/management.

111edevelopment and finalization of this publi- cation has involved many contributors other than the three authors involved. The report has been reviewed by the Scientific Comm it- tee of the EEA for which EEAis thankful.

The EEA hopes that this publication and the Internet -version with the prepared meta database containing information sources, will give increased accessibility to informa tion in the area of environmental risk assessment.

Domingo Jimenez -Beltran Executive Director

European Environment Agency

T ^{he aim of th is} book is to Rive an overview of the metho ds for. and app lication of, en viron - mental risk asse ssm ent in th e Euro pean Union.

It is not a technical "how to' g uide but examines the basic concepts applicable to all environmental risk assessments including human health risk assessments. ecologica l risk assessments and industrial applications of risk assessme nt. Exis ting knowled ge and research in this field is vast and th is book aims to identify unifying concepts. discuss currently used methodologies. examine their application and give examples of risk assessment in practice.

and guide the user to information sources relevant to their needs.

The book consists of an introductory text (Part

I)

and an information so urce-book (Pa r t II) . Th e first section of the text (Chapters 1-4) introdu ce s the concepts of risk assess me nt. summaris ing- its rol e as an enviro nmental ma nag em ent too l and th e method ologi e s currently be ing used . Thi s section is tar get ed towar ds a wide , ge ne ral audience. The inform at io n should be useful for individ uals in government. NGOs. as well as se mi-experts, studen ts and th e public inter ested in env iro nmental ma nagement. Th e second section (Chapters

5--7)

provides details of two general methodologies used primarily in a regu - Iatory capacity (health risk assessment and eco- logical risk assessment) and the application of env ironmental risk assessment in industry (pri- marily site-specific application of health and/or ecological risk assessment) . Chapters 5 and 6 are ta rgeted at semi-experts in local govern- me nt, indu str y. interest groups o r th e ge neral public req uiring inform ation on how risk assess- ments used to protect human he alth and the enviro nment are de rived , the methods used , and th e cons traints and lim itat ion s of eac h. The cha pters will also prove inter e stin g to

~GOs

and students. Cha pter 7 is prima rily tar ge ted

towards small to m ed ium sized enterpr ises (SMEs) to provide th em wit h a back ground know ledge of risk assess me nt proce sses bein g car ried out by major industria l org anisations and to provide information all how th is enviro nmen- ta l managem e nt tool ca n be used to be nefit industry. Ce rtain par ts of the text target particu- lar indus tria l sectors such as off-shore. contami- nated land and was te management. Much of the chapter will also be of inte re s t to the general public and inte re s t groups. '111(' third section (Chapters 8 and 9) is devoted to risk manage- ment and evaluation (Chapter 8) and future policy and development directions (Chapter 9) for risk assessment. Chapter 8 includes the examination of the important trade-off be tween perceived risk s and benefits in evaluation.

Cha pter 9 ex ami nes current thoughts on the pro ble ms of ris k assessme nt and the proposed solutions. It also look s a t possible future policy moves in ERA This section is relevant to tho se decision-maker s conte mplating-risk-based deci- sions and needing an introdu ction to evaluation an d manage me nt princip les. and a wide aud ience inter ested in t he soc iologicalas pec ts of the risk manage me nt proce ss and the pro blems associate d with risk assessment and manage-- ment.

Part I of the guidebook provides an introduction or a "taste" of the subject area, Part II provides comprehensive sources of specific, further infor- mation for each area covered in the text. It is a guide to "wh at is out there" on environmental risk assessment.

Part II of the gu idebook is an informatio n

:;;OUflX'S

direc tory comprised o fseven sec tions:

1)

Organtsattons; informat io n

Oil

in terna-

tional. EU and na tion al o rg-anisa tions

involved in a br oad range of wo rk o n e nvi-

ronme ntal risk assessment.

2) Da ta ba s e s ; information on databases providing data which can be used in the environmental risk assessment process such as toxicological data on chemicals and information used in food safety and industrial site-specific risk assessments.

3) Softwa re Model s; information on a wide range of risk assessment software models available.

4) Publicati ons; bibliographic lists of books and journals covering all aspects of risk assessment and management, and a list of bibliographic databases available in the EU.

5) Directories; lists ofdirec tor ies of environ- mental consultants availab le in the E D and sources of relevant information.

6) \Veb Sites; infor mation on web s ites pro- viding material relevant to environmen tal risk assessment.

7) Legislation; European legislation re levant

to environmental risk assessment.

Introduction

This first section of the book provides informa- tion on the general aspects of environmental risk assessment and management; the core concepts, definitions and terminology, its use and application. its limitat ions and the scien- tific unce rtainly involved.

It is comprised of four pha ses:

i. An intro duction to th e concept of risk. risk assessment and risk management and how these concepts. in combination. can be used as an effective tool in environ- mental management and protection.

ii. Specific uses of environmental risk assess- ment such as regulatory and policy design and decisio n-making. and site-specific decision-making, and the good and bad points of the tech niques.

iii. A typology of usc.

iv. An atte mpt to dra w togethe r common pr inciples underlying all environme ntal risk assessments and prod uce a ge neric mod el. using a pract ical exa mple, to clarify and illustrate the stages of the envi- ronmental risk assessment process.

Chapter 1 provides an introduction to envi- ronmental risk assessment. It assumes the reade r does not have a detailed knowledge of risk assessment but under stands the basic concepts of science. It cover s the definitions used in environmental risk ass essment and

"sets the sccnc'' for the rest of th e book.

Chapter 2 looks specifically at the use of risk ass essme nt as an enviro nmental management tool. Th e chapter aims to outline the major ways in which risk assessment is used and gives specific examples of such use in Europe.

This allows the reader to see how the concepts

discussed in Chapter 1 are applied in practical situat ions, from the regulation of chemicals, to the dumping of the Brent Spar. The chapter also points out the advantages of the tech - niques and the criticisms.

Chapter 3 is designed to illustrate the wide variety of uses of environmental risk assess- me nt. For each use, the speci fic metho dology may vary but the cor e prin ciples and the stag es in the process are funda mentally the sa me. Recognisi ng this variation in applied meth od ology. Chapter 4 ide nti fies the common thread and ru ns throug h the e nvi- ronmental risk assessment process. step by step . using a site-specific example of the siting of a new refuse incinerator. It describes a generic environmental risk assessment meth odology which inclu des the steps required in all types of risk assess ment.

This secti on of the book is target ed at a wide

audience. from those with little or no kno wl -

edge of e nvironmen tal risk assessmen t to

those who are familiar with it in their own pro-

fessional field. but are interes ted in

approaches used in other areas. It is educa-

tional. but familiar in style, and is pitched at a

level which should provide interesting reading

to anyone who needs. or wants, to find out

about measures in place or use d to protect the

environme nt. from an international to a l ocal

scale.

T ^{his chapter is a general} introduction to environmental risk as sessment and exam ines its basic concepts - hazard. risk. risk assessment. risk man agement. risk pcrcep- tion and risk communication.

The tech nique of risk assessment is used in a wide r ange of profes sions and academic subjects. Engineers "risk assess" bridges to determ ine the likelihood and effect of f ailure of components , and social welfare workers

"risk assess" their clients to determine th e likelihood of the reoccurrence of anti-social behaviour. Ri sk assess ment has become a commonl y use d approach in examining environme ntal problems. It is used to examine risks of ver y differ ent natures. For instance, the approach is used to assess the environmental risks posed by Genetically Mod ified Organ ism s (GMO s). chemical s.

ionising- radiation and specific industrial plants. Definitions in risk assessment are all- important beca use of the wide range of uses of the approach. and different mea nings of terms used by different groups of expe r ts and practitioners.

In this introductor y chapter some basic defin- itions are necessary.

Box 1.1

There has been a gradual move in environmental policy and regulation from hazard-based to risk-based approaches. A risk -based approac h attempts to examine the actual risks imposed by an environmental issu e rather than the potential hazards that may, or may not arise. An example can be draw n from the approaches used in dealing- with l and co ntam inated by toxic age nts. A hazard approach would be to identi fy the toxic age nts in the soil and requir e rem ediat ion measures that reduced the toxic concentra- tion to agreed stan da rds. A risk-based approach to so il contamination would begin

with

an identificat ion of the toxic agents" The level of dean-up req uire d would depend on the likelihood of people being exposed to the toxic agents and the likely effects of that level of exposure. The level of dean-up would depend heavily on how th e land is to be used and th e risk posed by this land -use.

'Illis move to risk-based approach es is partly

in recogn ition that. for ma ny environ mental issues. there can never be a sol ution tha t results in zero risk , and that in some instances aim ing for complete "safety" will impose heavy comp lianc e costs when att empting to re ach a standard which may not be necessary

Haza rd is commonly defined as "thepot entialto cause harm".A hazardcanbe de finedas"apropertyor situation that in particularcircu ms ta ncescould lead to hann" (RoyalSociety.1~r2) .Risk is a moredifficultconcept10 define .Theterm risk is used in everyday languageto mean"chance of disaster".when used in the process of risk assessment ithas specific rh-finltions. the most commonly accepted being "Thecombination ofthe proba- bility.or freq uency ,ofoccurrencenf adefined haza rd andth e magnitude ofth econse q ue nce s oftheoccurr e nce"

(RoyalSociety, 1992).

Alarge numberofche micals havehazar dou sprope-rtie s . Acids maybecorrosive or irritantto humanbeingsfor example .Thisisthehazardassociated withthechemical.Therisk of the add causingski nirritati onor havinga corrosiveeffect....illbedetermined by thelike lih ood that, in specificcircums tances.it....i11causeaspecificdegree ofharm.Ifthe personis only~oi nR"10rome intocontactwiththe acid afterit has beenheavilydiluted, the risk of skin irritation willbeminimal but the hazardous property of the chemicalwil lbeunchanged.This illustrates a fundamental concept. underpinning the theory of risk assessment;the nature of the hazard remains thesame,but exposure dictateswhether harm will actually OI.'TUr.

to protect humans an d the environment. For agen ts tha t are a ssumed tu have no thre shold of action , such as genotoxic carcinogens like benzen e. there is no level at which they can be regulated for "safety" or zero risk. Policy makers and regulators have to develop strate- gies for dealing with such agents, strategies tha t present an "acceptable" risk. Opponents to this view advocat e the pr ecaut ionar y princi- ple, minimis ing exposure to levels lower than those considered "acceptable" in th e risk- based approach, and removing or substitu ting those age nts considered to have no threshold of action.

Box 1.2

Ris k asses smentis the procedurein whichthe risks posedby inherenthazardsinvolvedinproces ses or situations are estimated either quantitativelyor qualitatively. In the lifecycle of a chemical for ins tance,risks canariseduringmanufacture,distri- bution,in use. orthedisposal process.Risk assess- rnent of thechemical Involves theidentification of the inhere nt hazards atevery stag"pand an estima- tionof therisk sposed bythese hazards. Risk is esti- matedby incorpora tinga measur eof thelikelihood ofthe hazardactually causingharm anda measure ofthe scvcrtrvof hann inter ms ofthe conseq uence s topeople orthe environment.

The scope and range of risk ass essments var y widely. Some look at single risks in a range of expo sure scenarios , an example is th e Environmental Health Criteria Document series produced by the International Programme on Che mical Safety. Others are site-specific an d look at the range of risk s posed by a particular installati on. An individual age nt in a particular enviro nme ntal medi a can be examined, such as a particular air or water pollutant. Some assessm ents go as far as to attempt to examine all t he environmental risk s posed to a town or city.

Th e foundations for risk assessment method- ologies have traditionally been based on the examination of effect s to human health but much more emphasis is now being place d on all environmental damage . Methodologie s to examine the threat s to ecosystem s from envi- ronmental risks are now being developed and used. In compar ison to hum an health risk asses sm ent , wh ich is in itse lf a relatively new field, risk assessment for ecological effects is ver y much in its infancy and the field is con- stantly developin g.

Box 1.3

In this report,environmentalris k assessm en t (ERA) is the examinati onof risks resulting from technology thatthreaten ecosystems. animals and people. It includeshumanhealth risk aSSeSSlll('IlIS.ecological or ecctoxicological riskassessments. and specific indu s trial applications of risk assessment that examineend-pointsinpeo ple.biotaorecosystems.

I n r ecent years th ere has been cons ide rable

activity in the field of envir onme ntal risk

ass essment. A larg e number of international

organisation s, such as the Organi sation of

Econ omi c Co-operation and Developm ent

(DECO), the \Vorld Health Organization

(WHO) and the European Centre for

Ecoto xicology and Toxicology of Chemicals

(ECETOC) . have been important in the devel-

opm ent of methodologie s, particularl y for the

assessment of chemical risks (van Leeu wen et

al., 1996). '111e Commi ss ion of the European

Communities has used risk ass essment as a

major approach to environmental issu es . The

regulation of GMO s, ionising radiation and

chemicals are im port ant examples. Becau se of

the wide range of organisation s involved in the

development of risk ass essment. there are dif-

ferences in appr oaches to risk asse ssmen t

This has lead to calls for harmoni sation . In the

field of chemical safety, the International

Programme on Chemical Safety opeS) is leading a project that aims to develop an understanding of the methods and principles used by countries and organisations . The development of a willingness to work towards convergence of these approaches is seen as a long-term goal. IPes are also working with OEeD on a harmonisation of hazard/risk assessment terminology (van Leeuwen et al..

1996) .

Difficulties in using many environmental man- agement tools include the availability and treatment of the basic scientific data on toxicity, ecotoxicity, fate and transport models, and exposure models. In approaches that are dependent upon estimates of risk as their basis, this area becomes crucial. The basic data. if available.

afe

often loaded with uncer- tainty.

When

faced with using data fraught with scientific uncertainty, two approaches are possible. Some people would choose to assume that substances or agents are harmless until proved (by science) to have harmful effects. Others would assume that agents are harmful until proved to be "safe".

The precautionary principle is fundamental in the European Union's approach to environ- mental issues. At the Bergen conference in 1990, ministers declared that "Environmental measures must anticipate, prevent, and attack the cause of environmental degradation.

Where there are threats of serious and irre- versible environmental damage, lack of scien - tific certainty should not be used as a reason for postponing measures to prevent environ- mental degradation"

(O'Riordan

and Cameron.

19<-)4). In the use of risk assessment as part of a risk-based approach. complex methodologies have been developed to attempt to deal with uncertainty. These are used so that uncertain data can still be used in assessments and deci- sions can be based on those assessments.

Where causation between the agent and an effect are not proved. the data are unlikely to be used . Many see this as in opposition to the precautionary principle (Gee, 1997). A precau- tionary approach would be to do as much as possible to reduce the emission of the agent potentially causing a serious environmental threat before science has proved or disproved causation. An approach based on risk would be to do as much as is necessary to achieve

"acceptable" risk based on the results of the risk assessment. The results of these two approaches could lead to very different outcomes.

11](' risk assessment may include an evalua- tion of what the risks mean in practice to those affected. This will depend heavily upon how the risk being assessed is perceived. For example, the risks from hazards that are borne voluntarily will be evaluated differently to those that are imposed. Risk evaluation is fundamentally subjective and for this reason some practitioners prefer to separate this stage from the more 'scientific' estimation of risk. This traditional view of a risk assessment being a wholly scientific process has been challenged in recent years and there is a growing acceptance that judgement and values form an integ-ral part of any risk esti- mation and assessment. In the US, this issue has been recognised by the National Research Council who arc influential in developing risk assessment methodology (l'\RC. 1994). A recent NRC report actually recognises that for successful risk assessment. the characterisation of the risk must be undertaken at the outset in a way which addresses the divergent value judgements of different interested parties and groups (l'\RC, 1996).

An issue that has been important in risk

assessment. especially for those who are trying

to examine the decisions arising from it, is the

8011.4

Riskmanagem e nthithedecision-makingprocess through which chokes can be made between a range of options that achieve the "required outcome ". The "requiredoutcome" maybespecified bylegislationbyway of environmentalstandards.

may be determinedbyitformalismrisk-rust-benefit analysisor may bedetermined by another proc ess for instance "industrynorms' or"goodpractice".It shouldresultinrisks being reduced to an"accept- able"level withinthe constraints ofthe available resources.

Ri" k perception involves people's beliefs. attj- tudes. judgements and feelings. aswenas the wider social or cultural values thaipeopleadopt towards hazards and their benefits. TheW3)"in which people perceive risk is vital in theprocessofassesss,ing and managing risk. Risk perception ....ill be a major determinant in ....hether a risk is deemed. to be

"acce ptable" and whether the risk management measuresimposed areseen10rt'SOlve the problem.

Riskcom m u n ica tionis an increasingly important Mea ofrisk management. Risk communicationis concerned with the way in wh ich informat ion relating to risks is communicated and is closely linkedtorisk perception.Ris k communication ran bea one-way trans mission of infor mation.impart ing safety propaganda for ins ta nce.throuch to atwo- way exchange of views Oil the risk between the

"expert' assessor andthe"public",

separation of risk assessment and risk man- agement. In the United Slates this has been a major issue as recommendations for the sepa- ration of the "scientific"process of risk assess- ment and the policy process of risk manage- ment were made by the National Research Council and others (:\ RC, 1 983: Carnegie Commission, 1993). and this has been the approach of regulator y bodies. such as the US Environmental Protection Azcncy. A recogni- tion of the

difficulties

in attempting to separate science from policy has also occurred in the US and there has been a move away from this view. This issue is less relevant in Europe where there has always been recognition of the blurred dividing lint' between assessment and policy. In Europe more emphasis tends to

be put on stating defined decision criteria and recog-nising the influence of societal values on the conduct of environmental policy (McCarty and Power. 1996).

Ris k can be managed in many ways:

• The risk can be eliminated. A total ban on th e use or market ing of a hazard ous chemical is an example of risk elimination.

H owever, risk eliminat ion is often not possible as other chemicals will be used to replace the one banned. In this case , one risk had been substituted for another.

• The risk can be transferred to other bodies. for instance industry may transfer the risk of envi- ronmentalliability to insurance companies.

• 'Th e risk can be retained by a company or government. This loan be done knowingly, for instance where a company assesses the risk and makes provision to cover the costs of any harm that may arise. Risks are more often re tained without knowledge, for instance where assess ments have not been carr ied out or the hazards have not been identified.

• The risk can be reduced. In most policy and regulatory decisions, risk reduction i s the 1110st common approach to risk management.

Although risk reduction is usually associ- ated

with

regu lation, there are may other ways in which it can be achieved. Examples are voluntary industry agreements and the provision of good risk information to con- sumers who can then choose lower risk products.

Ri sk reduction choices are based on much

wi der i ssues than the resu lts of the assess-

ment alone. Factors. such as the health and

environmental goals of the industry and gov-

er nment, the economic, political and social

importance of the industry and the agent that

is creating the ris k. the influen ce of consumer.

environ mental and worker organ isation s and their perception of the risk. and the availability of substitutes for the ag ent s creating the risk , are al1 impor tant. TIll' level of risk remaining after ris k reduc tion has been impleme nted will be decided upon

by

indus try and govern- ments, taking into account th e views of the stakeho lders. Economic. social, political and cultural factors all 11('('d to be cons idere d.

which may vary from co untry to country, This often means that achieving internationa l con- sensus on risk reduction is very difficult.

It is important to note that although risk assessment is used extensively in environ- me ntal policy and regul ation. it is not without contro versy. Althou gh it provides the scientific

found ation for much legislation an d enviro n-

mental policy, the re sults of risk assessme nts

ar e often 110t univer sally accepted. 111C major

contentiou s areas includ e the availability and

qu ality of data used in risk assess me nt. the

interp retat ion of the data and results of the

assessm ent, the basis and motivations behind

th e judgeme nts tha t are funda me ntal in the

assessment of risk. and the treat men t of uncer-

tainty. Risk mana gemen t is also hugely contro-

versial and issues such as the ineq uitable dis-

tribution of the costs and benefits of risk, the

methods and validity of valuing costs and

benefits. and the incorporation of people's

values and perceptions into decision-making

are all important. These issues are discussed

in Chap te r 8.

T his chapter examines

IIt(·

role of risk assess- mcnt and management in environm ental management. The us e of risk assessment by go vernments and regu lators in

policy

and reg- ulato r y decisions is discu sse d. as is the use of the tool by European ind ustr y. TIle cha pter aims to outline th e majo r ways in which ris k assessment is used and gives spec ific examples of such usc in Europe. TIle examples highlight som e of the difficult ies involved in the usc of risk assessment and the subtle differences that a rise in different EU s tates.

.\l ore discu ss ion of t he ben efits of. and pitfa lls associated with the usc of risk assessme nt and management as an enviro nme ntal man- agement tool is contained in Ch ap ter 9.

2.1 The use 01 risk assessment and managemenltechniques in policy and regulatory decisions

In recent years, risk assessm ent and manage- ment approaches to environmental issues hav e become incr easingly important.At a globallevel.

for instance, risk assessment is the major approach to controlling chemical risks in Agend a 21of the United Nations Confe rence on Environment and Development

(UNEI~

1992). A r isk-based approac h to environmental problems is also bec oming common in European cnvi- ronm cnt al legisl ation and policy.

Risk assess ment and man agem ent techn ique s are used as decision-making tools in regulation . The range of applications is wide and includes :

• th e des lgu of regu lation . for insta nce in deter- min ing socie tally "acceptable" risk lev els which may form the bas is of enviro nme ntal

standards;

• providin g a basi s fo r site-specific decisio ns . for instance in land-use planning or s itinJ! of hazardous ins tallations:

• prioritis aticn of environmental r isk s, for inst an c e in the det e r m inat ion of which chemicals to regulate first:

• comparison of risks, for instance to enable comparisons to be made between th e resources be ing alloca ted to the con trol of dif fe ren t types of risk . or to allow risk s ub- stitution de cision s to be mad e.

2.1.1 Risk assessment and management in regulatory design

Risk assessm ent can be used a s a de cisi on- making tool at nat ional and regional le vel in the design of re gul at ion. Whe n assessment of ris k is used as part of a risk ma nageme nt approach:

• targets for regulation can be selected:

• societally "acceptab le" risk levels ca n be determin ed ;

• deci sion s can be mad e on the appropriate level of ris k redu ction .

R isk assessment and managem ent ap pr oach es attempt to pro vide a form alise d framework with in wh ich de cision-make rs can compare the harm caused by the ris k with the ben e fits associated with it and choose ap prop riate risk reduction measures.

For ins tance. when examining th e risks posed

by che mical use. the overrid ing aim of a risk

assessme nt and man agement approach is to

enable objective decisions to be made on

wheth e r the risks po sed by a che mical, at a

certain do se. outweigh the b enefits pro ffered

by its use. Risk ass es sm e nt an d manag eme nt

techniqu es offer reg ulators (bot h nation al and

region al) of che mical ris ks a methodology to

evaluate bot h th e be nefic ial and negat ive

impacts of a chemical on society, A fundamen-

tal. and ultimately political decision . has to be

made by regulators in weighing up the costs

and benefits. Numerous approaches arc used to determine "acceptable" risk levels. Th ese are discussed in more detail in Chapter

8.

It is clear, however. that a political decision has to be taken as to what extent the costs of the

chemicalhaveto exceed the benefits of its use

before risk reduction measures are required.

By us ing risk assessment and management techniques, the risks of defined health or eco- logical end-points occurring can be explicitly estimated using scientific techniques within the limits of the available data. Various options to

reduce the risk can then be examined

by

using criteri asuch as; the cost requiredfor achieving a certainreduction in risk, the feasibility and practica lityin reducingthe risk and the social im pact

of

reducing the risk.

One very common approach used in defining a level of risk that is"acce pta ble '! and to assist in choosing

between

risk reduction optionsis the concept of

AIAHP

(as low asis reasonably prac- ticable).

AIAH P

compares the costs of the risk existing with the costs that

will

be imposed by tryingto reduce the risk.

The

riskneedsto be reducedto aslow as itis reasonablypractica ble.

This is fundamental in

the regulatory

frame- work of the United Kingdom where leg al case law and policy exists defining

AlARP

in the realm of occupationalhealth and safety. AlARP is also enshrined in Dutch policy on environ- mental risk(see Box2.1).

A

very

important

step in the use of risk assess- mentin regulatory design carne

with

the approach taken

by

the EC legislation relating to new and existing hazardous substances.

The risks

from new and existing substances are assessed and risk

management

decisions taken on the basis of th e results.

This will

be considered

in

more detail in Chapters 5 and 6 wherethe EU approach to risk assessmentof chemicalsisexamined.

Box 2.1 The use of risk assessment and management in environmental regulation in the Netherlands

In the Net herla nds. risk management approaches werefirst introdu ced in the1986-1990Program me for Environ ment al Manage me nt of the Dutch Government. This concept of risk managem e nt recognised the impo rta nce ofan"effects-oriented approach" (e.g.. environmental quality sta ndards andeffectsstand ar ds) in additio n to a"source-o rie-n- tared approac h" (e.g'..emissionstand ardsbasedon thebest available tec hniqu es notentailingexces sive cost (BAThEEC»).TIle risk management policy sets outcriteria for judgingrisks oftechnological hazardsbasedon the followingconcepts:

•That amaximum acceptableleve lofrisk can be lden rlfied which should not beexcee ded irre- spectiveofthe economicor soc ialbenefit that could resu lt[tom the activityunderccnsidcr a- tion.

•Th ata negligible risk level can be identified at which it not sensible to try to reduce the risk further.

•Thatbetween these two levelsthe risk shou ldbe reduc ed to as lowas is reasonably practicable WARP).

111('risk criteriaderivingfrom suchapolicy arc laid outexplicitlyin'Premisesfor Risk Managem e nt' which is partofthe National EnvlrnnmentalPlan (Mi nis try of Ho usi ng'. Physical Plan ning and Environment.1991).

The

use of risk assessmentandmanagement at regional or international levelscan cause difficul- ties due to the varying social.economic and envi- ronmental conditionsin different nations. See

Box 2.2.

Har monisation of nationalapproachesto risk assessmentandmanagementwithin theregu- lato r y frameworkcan be restrictedbecauseof the differencesin the policyobjectivesofthe nat ionsconcerned.

This

is illustrat ed by the differences in approach and outcome of risk assessmentson CMOs between different states.

See Box 2.3.

Box 2.2 DECO'srisk reduction programme · difficultiesof agreeing international ris k reduction measures

TheGECD progr amme on che micalriskreduction set up in1990attempts to agree substantiveinternational action. In the pilotstage five chcmlcals . lead. brorninated flame retardants.cadmium. mercuryand methylene chlonde.weresck-c'ted for examination. Agreements were reached on cadmium, lead and brominared flame retardants.

Theagreement reach ed onlead falls shortof the-prescriptive action called forbythe liSA and ECunder the CouncilActs.TIlt' Decla ration unlead "recognisesthe differi ng needs and circu mstances of theMem ber coun- tries which callfor flexiblenationalrisk reduction strategies and time frame s." Den mark wasparticularly unhappyaboutthelead declaration and wish ed to secall OEeDcountr ies follow a principle of minimisation of risks andsubstitutionofthemetal.

Oncadmium, theOECD has staledthai "because ofthe varianceinIhC' natureofexposures andin environmen- talconditionsinOECDmembercountries. it wasaccepted thaidirectaction10reduce risk from exposure to cadmiumis mostappropriately taken at thelocal, national or regicnallevel." Scandinavian countries. backed b)' the Dutch. Swiss and Germansled a push for international controls on cadmium use. citing the transbcundary impact s of exports of food. fertilisers and other products such as batteries. The International Cadmium Association backed by theUK.Australia. Canada andthe UShasargued foractionbasedonnationalneeds . Sweden andether Nordiccountrieshave alrea dy imposed stringent controlsandphase-outs10contr ol exposu re to cadm ium. The variation in national views 011 cadm iumhij{hli~ht differences in the interpretation ofthe precautionaryprinciplein Europe .

The agreementofbrormna tcd flam e retardantsinvolves a weak voluntarycomnnnmen ttocontrolthe-manufac- tureofcertainretard an ts.

The pilotscheme indicatescwarl)' the huge difficulties in aj..,'IT't"ing internationalaction on chemical risk reduction wherevariationsin riskexist indifferent states (due to different patternsof use. exposure and environme ntal conditions)and the proposedactionhas differe ntsocio-economicimplications indifferent states.

The riskreductionprogramme s oftheOECDwill takeanew approachof focusing onmethodologiesratherthan specificchemicals. In additionthe GECDis10hold workshop stoexaminethe valueof non-regulatorylnitlatives .

2.1.2 Risk assessment and management in site-specific Dr regional decisions Anexample of the incorporation of risk assess- ment in regulation for site-specific problems is the 'Scveso' Directive (EEC. 1982). Th is requires operators of relevant industria l sites to provide evidence that the potential major accident hazards for the site have been identi- fied. and that adequate steps have been taken.

both to prevent such accidents and to limit their possible consequences to persons and the environment. This legislation requires a form of site-specifi c ERA See Box 2,4,

Site-specific probl ems such as a geographicall y distinct area of contaminated w ater or land can be dealt with by ERA This characterises the health and ecological risks.

posed

by the site

and identifi es risk reduction options. Using defined criteria, the most appropriate risk reduction measures are chosen that reduce the risks to an "acc eptable" level at an "acceptable"

Box 2.3 Disharmony between GMO risk assessment approaches

Because of several difficulties discovered in the implementationof the 1990 Directiveon Deflberare Releases of Genetically ~todified Organisms into the Envi ron me nt. the Directive has been under review. The Direc tive specifies the data ...hich member states mustobtainfrom companies and asse ss todecide whetherto approve expe rimenta l or commercial releases.However.it appea rs tha t theyhaveapproached assessments with different objectivesin mind.resultingin a "lackof harmo ni.

sation". Guidelines an-currentlybein~dra..vn up by the European Commission in an attempt to address this problem (ENDS.1996),

repo rts layouta well- definedandstandardmethodologyfor quantified riskasses sme nt (Ministry of Soda! Affairs andEmployment ,1988, HJH!:l, 1990.ThelJKGovern lllcul hasproducedguidance on theeffectsonthe environment that wouldconsnrutca major accide nt.Itisatte mpting. with industrial collaboration. to relatethese cffl-l'tsto the amountofche micalinthe environmentthatwould causethisamountofdamage. A majordiff ....uIty thathas been experienced is thedeterminationofthe si!{TIificann'of thedamage.Workis beingcarried out to develop a semi- quantitative ranking system for environmentaldamagebasedon a compilation of all criteria used tu value the environment (DoE, 1991).

cost. ERA is thu s useful in land-use plan ning- o r siting deci sion s. A diffi c ulty in such decision-m aking is that th e risks a nd ben efits generated

by

new hazardous installat ion s are neve r d istributed equ itably.

The

qu est ion of

"acce ptable to whom " always arise s.

PhotO· Graham Bums. fnVlroomentallmages

l

Contaminated land sites a re an example whe re risk-based regulation is being used in Europe.

In the UK and Sweden . the risks posed by co nta minated lan d sites are assesse d in rel ation to th e land' s propo se d use and re me- diation mea sures are required based on a risk manag-ement approach.

Deci sions on the be st approach

10

be taken in resp ect of sectors of industry or distin ct

regi ons

can be tak en after considering the risks po se d by eith er the specific industr y sector or the industri al sources within a region. See Box 2.5.

2.1.3 Risk assessment as a tool for priorilisation of agents for risk reduction

Risk asses sme nt ca n enable com parison s to be mad e between differen t ris ks. This is useful in the prioritisation of chemicals and in evaluat- ing' the bas is of regulatory action for different risks. See Box 2.6.

Risk assessment incorporates bo th available hazar d and

exposure

data. It thus e nables pri- orities for action to be made on the basis of the act ual risk pose d rather tha n pote ntial haza rd . In its mos t complete form. the results of a risk asse ssment will give detailed infor mation on the effects of the risk. the likely actual exposure to the chemical in a range of exposure scenarios , and estimates of likelihood of the chem ical

Box 2.5 Integrated regional risk assessment

A four-year collaborative research programme in Switzerland has been carried out to support aplan to providea "co-ordinatedstrategy for riskreduction andsafety/ha7.ard ruanazementin a spatially defined region atTOSSa broadrange ofhazard source sthat includessynergistireffect s"(GIll'org-heand Nicole t- Monnie r, 199[)).The project addresses the risks frumboth routinerelease s from industryandat-c·i- dental releases. This. method of regional risk assessment could prove a useful tool for risk managers and regional planners.Itmay assistinthe determinationof "acceptable"levels of risk tothe publicand environmentintheface of theincreasing complexity oftechnologicalrisks andtheincreasing density of hazard sources suchasindus trialdevol- opm entsand road tran sport.

Anexample ofan integrated regionalrisk a....·;j··,;..."iITIt'IlL the ChesterRi.",kA....scesrentProject.ulI..wporares1101 onlyindustrial risksbut thoseposedbytransportation and natural sources in the city of Chester, CSA

(I1ttrx!/www·.emiro1ink.orWorxs/pen/rn:qVuKb.htrnl).

TheCommission will use the following steps in prior-itisation:

Part I: Consolidate and distribute 111(' International Unifonn Chemical InformationDatabase([LieUD;held at the Joint Research Centre inIspra.

Part II: Rank the IlJCLlD substances using an automated ranking method. This methnd . InformalPriority Setting uses criteria such as physico-chemical properties, environmental fate and pathwaysdata,toxicityandeco- toxicity data'

Part III :Di~tributethe ranking and underlying data used10Member States and Industry:

Part IV:Introduce expert judgement into the ranking by Member States andIndustry and finalise unking:

Part V: Produce a proposal for a priority list.

TIll'priority setting stage will use data available from IlJCt.l 1J and will be similar to the final risk.ls..;ess nw nl.

However the priorityranking-isconcern ed withrelativeconcern between all1l.:CUDsubstance-and canhe based on much less data than the risk assessment (CECjECB,Hl93).

The major difficulty inthe lise of Stich an assessment system is the availability ofthebasicdata. TIle'titvclo pnu'nt oftheIUCLlD database is inprogressbuttronly includes those few thousandchemicalsthat arcmnrkeredand sold in amounts exceedingWOO tons per year.Before-1998,producers and importers wi\l have to submit(limited) documentation on substances marketed in amountsaboveIO tonsperyear if the data is alreadyavailable.The huge data deficiencies are highlightedin a report from theDanish Board of Techn ologythat slate" "The vast majority of the chemicals onthe EIKECSlist havenotbeen assessed for hazards orris ks10man and the envi- ronment, or they may be short of data for proper assessments"(DanishBoard ofTechnology.1996).

having the effects identified at the exposu res estimated. On this basis it is possible to rank chemical risks. TIle ability to provide detailed risk assessments for che micals is depende nt on the availability of good quality toxicological data. 11 1is is a major problem in lise of risk assessment as an environmental management tool. as complete data are available for ver y few chem icals.

Risks are ver y rarely ranked purely on their negative impacts. Regulators can choose to incorporate the following issues:

• the social, economic and political impact of the

riskreduction

measures foreach of the chemicals

• th e practicality of risk reduction and

• the constraints of existing national policy and legislation that define how certain risks have to be dealt with.

2.1.4 Risk assessment as a tool for comparisons to be made between risks

A risk assessment may point to inadequacies in existing action on controlling risks by contra sting the resources that are devoted to comparatively

lower risk agents to those with higher risks.

Th is enables regions and nations to select targets for regulation.TIle aim is to ensure that the most severe risks are dealt with first and that the costs imposed on industr y to achieve a societally agreed level of control is appropri- ate to the degr ee of risk. Risk assessment and managemen t approach es are therefore an import ant tool for environmental manageme nt in a climate oflimited r esources (see Box 2.7).

TIle ultimate use of this type of risk comparison has occurred in the United States. Govern ment studies have examined the effectiveness and basis of environmental regulation by calculating the

Box 2.7 The use of risk assessment and management in the UK regulatory system

IntheUKrisk assessment and management are beingincreasinglyusedin regulation.TIlt'Department of Trade andIndustry (IfIl) for instance,set-srisk assessment as a technique for enabling decisions about regulation to be in proportion to the risk. Risk assessment ofregulatory proposals is required to ensure that regulationis justified on a formal risk benefit basis as part of theUKGovernment's dcrcg- ulaticninitiative (DT!. 1993. t994).

co-n of e ach life saved by en vironmentallegis- lat'on regulating specific risk s (US EPA.

1% 7) . Rec en t US legi slation also requires ris k ass essment and risk-benefit analysis for all new

rec-rlation (RiskAssessment and

Cost-Ben efit Act 1995 available on the inter ne t at httpr/ ywww.thomas.loc.gov) .

'Inc use of such risk comparison s is justifiable from the viewpoint of the e fficie nt man age- ment of enforcemen t resources. A quest ion shou ld be raised as to whe ther all environ- mental ris ks need to be dealt with in the sa me way. Why should the amount of money it c osts to save a lift' through regulation he the basis of whether. and how, risks are controlled by Government s? This approach does not take into accou nt how e nviro nme ntal risk s are per- ceived and the priorities of the public. which sh ould be a fundamental consideration in any leg islative frame work.

An

example can be

drawn from risks in food. TIll' health risks posed by eating barbecued foods are assessed scie nti fica lly as being g reater than those posed by pesticide residues in food. Shou ld the fact that the majority of the public would not wish to see the barbecu ing of food con- trolle d by le gislation have any effect on the regu lation of pesticide residues ?

The use of risk comparisons does illuminate many areas where the decisions on controlling the risk are dominated by factors other than the science involved. '111(' difficult decisions have to be made once the compa risons are made .

Comparative risk is a relatively new field in Europe .

Risk

co mpariso ns are becoming ens hri ne d in en vironm enta l legi slation, however. and their use is likely to increase, See Box 2.8 and Box 2.9.

Box 2,8 The Proposed EC Biocides Directive

~

a contentious use ot risk comparisons

The draftDirectiveon biocides sets up aharmo nised system of control over the placing on the EC marketof a wide range of products- from householddeter ge nts toind ustrial rodenticides and anti-fouling"agents - based on an assessment ofthe risks they poseto human health and the environment. Arevised proposal incorporatesan annexcontaining" a framework ofcommon principlesuponwhichmemberstatescanbase decisions toauthorise products(EC,1995).

One proposa l in the Dire ctive th athas provok edinten seopposit io n is "comparativeassessment". TIll' debate is signiflrumbecause the BiocidcsDirectivewouldbethefirst10ensh rine thisconcept. TIll'Directiv ewouldallow the inclusion ofanactiveingredient10 be refu se d "if the re is ano th e ract ivesu bsta nce...forthe same produ ct type or ano th ermeth od ofruntmlexists, which in theliR"hl ofscieruific ortec hnica lknowled g e pre sents sign ifi- cantlyless risktohe alth orthe environment."T11Cprinci ple of subs titu tionbased on comparative analysis has long been supported b)'the Scandinavian Stales.AttheEnviro n me nt Council inDec e mber 1994, sevenMe m be r States - Belgium, Denmark,Germany.Austria.thexerncrtands.Finland and Sweden-entered astatementin the minutesasserting their bellefthat "bycomparativeassessmentas pro posed in the Commission proposal ...itis pos sible toreach ahighle vel ofprotectionof theenvironmentand health respecting thol''l.-oncmlcandpractical consequences for the user."TheFren ch and thoL:Kopposesuch com parat iveasses snu-nt.

TheSwedish Experience

In Swede nareview of:111 bioclde s onthe marketwas initiatedin1990,Produ ctsforparticu lar applications arc assessed simultaneously. enab ling regulat orsto take aholisticviewonthecomparative risksof substancesand theirimpact of theirwithdrawal fro m themar ke t. Swedenrecognises the limitati onsof comparativeassessme nt.

The differences in risk muslbesig"nifil'anttomake acomparisonjustified.andcomparativeassessment cannot be used. where a substance poses less risk in one area butthe alternativespost'less risk in others.The Swedish recognise that the economic and practical costs to the user must be considered.

Box 2.9 Controlon o ff·shore use ofchemicals - Oslo and Paris Commission (OSPAR)

At the OSPARmeeting in Oslo in June 1996, membercountriesag-reeda Declslon to introduce a manda torynotification and screening system for chemicals used by the off-shoreoiland gasindustry.

The scheme willrun [or atrial periodof 2 years.

Allapplicationsmade to the nationalauthor ities for the lise and discharge of chemicals will have to include standardised toxicity data inthe formof a

"harmcnised off-shore chemicalnotificationformat' (HOC;...rn.ln the case of currentlypermittedchem- icals. HO C ~Fdata willbe required on it priority basis, Chemicalswillbe runthrough a pre-screen- ing" processto enab lenational authorities Lodecid e whether they should be authorised or substituted.

As a basis fur such decisions, chemicals willbe subjectto a risk assessmentand ranked according tothe risksthey pose.Risk wil lbemeasuredusinR a methodologyknown asCHARM-chemicalhazard assessmentand riskmanageme nt. This bases risk on a Quotientbctv..con the predicted environmental concentration(PEC)and the no-effectconcentration (NEC)in a standardiseddischarge-scenario.Ifan operator decides to replace a chemical for an economic or performance reasons. the preferred chemical'sPEC/ I\E Cratiomustnot be higher than that of the substance currently in use.National aut horities "shall when taking regulatory action ensure that over time ashiftis rea lise d towards lowerrelativePEC/NEeratios".

2.2 The use of risk assessment and management techniques in industry

ERAhas traditionally been a function of policy and regu lator y agencies and most develop- ment has take n place ill these fields. ERA is becoming more- common in indus tr y part ly as a result of th e use of ERA in regulation.

2.2.1 Comp liance with legislat ion

In r ecent years, the focus of much Euro pean regu lation of chem icals and ionising radiation has been risk assessment. Many industries have been at the forefront of the development of ERA

techniques but nowthe approach is beingimposed on industr y by enviro nme ntal regulation .

TIll' I Seveso' (EEC. 1982) and COMAH direc- tives (CEC, 1994) requ ire major hazard indus- tries to produ ce

II

safety cases'' which include health and environmental risk assessments.

Th e COl\l AH dire ctive extend s the 'Seveso' directive by placing emphasis on safety man- ageme nt systems, and extended public infor- mation requirem ent on operators. and gives new right s to the public on siting and land use.

Th ese extensions to the 'Seves c' dire ctive rel ating to public involveme nt and information mean that major hazard industries will need to concentrate on how the public perceive risk.

This will become important within the regula- tor y framework (the way consumers per ceive risk has always been important for commer- cial purpo ses. now residents of local commu- nities will have a legal role in environmen tal decisions).

2.2.2 P rodu ct safety

TIle new and existi ng substances legislation on chem icals requires th at manufacturer s of chemicals assess environme ntal risks. This is examined in more detail in Chapte r 5.

Photo.Graham Bums,Environmental/mages

Manufacturers of products carry out ERAs.

Prueter and Gamble. for instance. have examined the fate of hypochlorite bleach used domestically (Schowanek et al.. 1996). This type of research is fundamental to good ERA.

2.2.3 Financial planning

Environmental risk assessme nt call be an important tool in fin ancial plan n ing for companies. As the methodology allows for the quantification of risk . this can be valued and financial appraisal based on monetary values performed. The risk assessment can form the basis for evalua ting the cos ts In the company of differ ent options for risk red uc tion. for instance in deciding how far risk reduction measures should go. Th e risks posed by different processes or operations can be eval- uated. for instance in deciding whether to transport hazardous materials by road or rail.

From the point of view of the company. the valua tion of environmental damage and life will be different fro m tha t carried out to reflect values at socie tal level. At a company level.

environmental valuation is likely to include only those aspects that directly effect them - insurance costs. compliance costs with lepisla- rton. cos ts incurred from contravention of legal liabilities - and as such may exclu de exte rn alities. 11 1(' risk of the costs of external- ifics bein g impose d on the compa ny is often insured against which may become a part of the environmental valuation by the company.

2.2.4 Site-specific decision making·

choosing between risk management options

Comp anies use ERAto deter mine the levels of ris k th at exist in a cer-tain proces s or plant to enable effective decisions to be made on how to deal with the risk.

For instance. th e risks posed by a par ticular process can be examined. 'Ole assessment of risk estimates the level of risk and an evaluation may be carried out to determine the significance of the presence of the risk.

Based upon this infor mation. decisions can be made as to whether the risk is retained. reduced to an "acceptable. tolerable or desir ed" level or transferred to an ins urance company.

2.2.5 Prioritisation and evaluation of risk reduction measures

Risk assessment and management can be important decision-making tools in evaluating risk re ducti on measures in industr y. The decision by a company to reduce the risk may be prompted by legislation. by financial considerations such as potential reduction in insurance premiums. by environmental or humanitarian considerations or by other commercia l factors. Risk assessment and man- agement can be used to de termine how far the risk has to be reduced. This will usua lly be in the absence of regulatory standards or where the company wishes to set their

0\1,11

internal

"acceptability" or "tolerability" standards.

111e

tec hniqu es

can be used to examine the

implications of risk reduct ion measures. Risk assessment and management in this con text is not a finite pro cess. All ris k reduction measures can be exami ned and the new situa- tion. post reduction. should be analysed. An important role for risk assessment and man- agement is to determine when to commence and importantly (for commercial organisa- tions) cease risk reduction measures. An exa mple of thi s appr oach is the guidance produced by CONCAWE, th e petrochemical industry group on risk red uction measures to be used in the petrochemical industr y

(CO~CA\\"E.

1996) or that produced

by

the

UK Petroleum Institute for petrol filling stations.

2.3 What risk assessment can and cannot do

Although risk assessment and management have, and will, continued to become increas- ingly impo r tant environmental ma nageme nt tools. it is im portant to look at what the tec h- niques can actually achieve and equally as importantly, what they cannot.

2.3.1 What is good about environmental risk assessment and management techniques?

They can be successful:

• whe re a technique is necessary

10

weig h up inform ation that is basically in different "lan- guages''. R isk assessment and management are often used in pub lic policy decision- making which demands that science and social. economic and political information is taken into account. Risk management tech- niques attemp t to provide a bridge between the scientific and the social.

• as a mech anism to aid decision-making espe- cially the choice betwee n options for action.

e.a., risk reduction options. Once you have determined the criteria on which cho ices are to be made then risk assessment and man- agement methods will aid decision-making.

• as a means of comparison betwee n risks to deter mine whether there is equity of action or that the action is proportionate to the risk.

• as they can break dOM! complex systems and identify areas of processes or plant where risk r eduction options can be most effective.

• as a basis for effective risk commu nication.

Ri sk assessment ran give a risk communicator the effective base for communication. However.

the limitations are clear. If the commu nicator wishes to convince a sceptical public or other interest group, they will have to address the value issues that underlie the perception of the risk.

• as a method for highlighting and prioritising research needs.

2.3.2 What are the pitfalls 01 environmental risk assessment and management techniques?

T h e techniques have been criticised for a number of reasons. some of which are not real criticisms of the techniques but are related to the philosoph ical basis of carrying out such assessments in the first place. The dumping of the Brent Spar is one such examp le. See Box 2.10.

'Ill

ere

are mar ry

criticisms that are focused

Oil

the use of the techniques. These include:

• That the use of scientific techniques such as risk assessment encourages an over-reliance on and over-confi dence in the results. This is par ticularlyfocused at risk areas where there are great uncertainties and conservative approac hes and safety factors are common . T h ose who query the certainty of the science will often claim that reliance on risk assess- ments based upo n uncertain science is ill-judged.

• Risk assessment focuses on parts of a problem rather than the whole. The most commonly performed risk assessments con- centrate on single chem icals. Site-specificrisk assessments may examine a number of risks but each will be done in isolation as the scientific data are not available for looking at mixtures of agents yet.

• In th e United States risk assessment is generally disliked by trade unionists, environ- mentalists and consumerists due in part to the valuation of life and environmental quality involved in many risk management procedures.

«The relationship between risk assessment and

manag emen t and th e precautionar y principle

is somewhat awkward - how precautionary do

Photo.OdVld Stmm.£nvironfll#Nl~I ITTlJges

The pointcrucia ltoenvironme ntalrisk asses s me nt andmanagementis thatmost of the publicargum e nt on the dumping concer ned the conten ts of the Bre ntSpar and the amountof damag e tothe deep- sea ecosyste ms that this would cause.These public argume nt!'> concern ed the technical and scienriflc aspects of the risk assessment.111('values of the

environmentalists and thoseopooshur the dumping meant that they believed thai nothingshould br-dumped in the sea.;-';0amount of scientific discussion andargumentwould haw counteractedthis belief.Itwas, however, these scientific and technicalissueson which thedecision-makingwas based,Itcan be seen that thetech nical assesso rsand thoseoppt)!'>in~rhr-dumpingwereactually arguingfrom differen tviewpointsandanswering dif- fe ren tquestions.Tothoseoppos ingthe dumping,afundament al issuewas notthe actualk-v elofdamagethe Bren t Sparwou ld causebutthe wholepolicyofallowingdumpingat sea.The recommen dationof the t.:K KERC formoreopendedslonmakingca nbeseenasanattem pt to addressthisprob lem,Controversialenvironmental dedstonssuch asthattak eninrela tion totheBrentSparneed tobemade inas tra nsparent<I ...ay aspossible, Theques tions that thedecision-mak ers were atte mptingtoanswer neededtobe clearly defined at thebeginning ofthe assessmentprocess. Therole of the wider polky issuessuchastheapplication ofthe precautionary prin- ciplenee dedtobedefinedat the initial stages oftheassessme nt.

TheBPEOdocumentsproduced by consultantsfor Shell contained anumber oferrors which lead to criticism with in the srier nificcommu nity. Thisleadto the UK government asking the UK Xarural EnvironmentRese arc hCouncil to set up an indcpen- de ntexpe rt group to"exa minethescientificevidence in relation tothe potential environmental impacts of larJ,l;{' off-shore structures.using till'BrentSpar as an example". l11C outcome ofthe inquiry was a call fur mort' open. independentdecis io n-making bUI thr -y did nut comme nt ondeep-seadumping.

Firstlytherewas a101 of confusiona!'>10 the make-up and contentsof theBrent Sparandtbc second issue concerned theargu ments intheBPEO study. The first iss ue was cleared in Novem be r 1995 when Det NorskcVcritaspublishedits independent luven- lory of the Spar's contentsconfirming the figures provided by Shelland correcting the Creenpcacc estimates .especiallyon hydrocarbon s.The second issu e, onthe BPEOi..more contentiou s.

Ultimatelythedec ision by Shell001todump inthe deep-seawasbased not unthe scientific evidence but011cum- mercialreality-theyrealised the potential commercial damage of g-oingahead anddumping .Thisindicates that values and other factor!'>were justas vital in Shell's decision-making as they wereinShell's opponents.

you have to be? Global w arming is an example of an issue where the science surrounding- an issu e is very uncertain but the consequence s of inaction an' huge. Doubt exists as to wheth er a technique such as risk assessment can be applied, A totally precautionary stance would be tha t as we are nol sure, then all action to prevent the conseque nces that have been hypothesised. should be take n, In the rea l world where the action req uired for pre-

venting global war ming has enormous social,

political and eco nomic repercussions this

may not be possible, A techn ique such as risk

assessment and management that is able to

incorporate such issues 'hill look attra ctive

but how precautionary do we nee d to be in

the assessment to take account of the unccr-

tainty? The need of dev elopm ent work

addressing the se problems are describ ed in

sectio n III

A s seen in Chapter 2, the uses of risk assessments are wide and varied. The risks examined in the assessment can be physical such as radiation. biological such as a genetically modified organism or pathogen, or chemical such as an immuno-toxic substance.

The target /receptor to be examined in the ris k assessment can vary. Human beings are the species most extensively considered in risk assessments - human hea lth risk assessments - but other single species risk assessments are common. Many ecological risk assessmen ts can be considered single species. since only a few types of representative organisms are selected as assessment end-points (Landis et al., 1995). TIle end-points examined in th e risk assessment are varied. They can be mor tality or morbidity in human health assessments or other single species assessments. For some ecological risk assessments, end-points may be extinction or total catch. Some ecological risk assessments use end-points that indicate biodiversity or disturbance to ecological systems.

In this Chapter, a typology of risk assessment methods in use or development will be oullined. 111e typology is shown in Figure

:~.1

and breaks environmental risk assessment into:

• Human Health Risk Assessment

• Ecological Risk Assessment

• Applied Industrial Risk Assessment The basis of the human health /ecological split is that although the two processes are conceptually similar (in fact ecological risk assessment has developed from human hea lth risk assessment), the two have a differing historical development and regu latory and policy imperatives. Applied indus trial applications have been separated as many of

these assessments do not look in isolation at people or ecological syste ms. Th ey look at real situations and lend not to be as "pure" as the first two categories. 111ey are likely to include engineeri ng risk assessme nts as part of the overall enviro nme ntal risk assessments and may take an integrated approach to h uman and environmental risks. They are likely to lay much more importance to ensu ring that the risk assessment can be used in risk manageme nt decisio ns as the object ive is more dear-cut - to make a risk management decision intended to protect hum ans and the env ironment (an d the co mpany) within defined spatial boundaries.

It willbe noted that the human health typology and th e industrial use typology arc more detailed th an tha t for ecolog ical risk assessment. 111 is is because these are the areas in which the met h odo logy is most developed.

Th e typology does not outline all the poss ible types of risk assessment. In the area of ecological risk assessme nt, there are many developing techniques and much research is being car ried out to de fine suitab le end-points.

TIle typology of ecological risk assessment shown, is tha t currently practised, or tha t in an advanced state of deve lopme nt in govern ment or indus try.

The typology for indust rial application for risk

assessment is based on use of the me thod

rather than the type of metho d.

Figure.1.1:

A typology 0/ risk assessment

Source:Fairmanand Mead. 1996

T h iS chapte r exa mines the st.e ps required in all type s of ris k assessment. As see n in Chapter 3, the number of hazards that ca n be examined th rough ERA is vast, and numerous specific tech niques have developed to

('01)(>

with the characte ristics of different hazards . Techniques have also evolved differently due to th e institutional basis of the risk assesso r and th e inte nded usc of the risk assessme nt.

On first sight. the type of risk assessment carried out within an industrial plant will bear little relation to that carried out by a reg u latory agency. In the scientific literature. the model developed by the National Academy of Sciences (NAS) in th e US in 1 983 (NAS/I\RC. 1 983) which looks at chemical risks to hu man health is widely use d and accepted. This method . whic h has formed the basis of the El.I's new and existing chem icals legis lation. is the pre- dominant model in huma n healt h risk asses s-

merit. used by regulatory or policy-makin g orga nis ations and the meth odol ogy doe s not fit well with site-specific o r process /plant risk asses sments. In site-specific asse ssments . an add itional step examin ing how. why and when the hazards are going to ge t into the environ - men t is re qu ired .

'IlH."

NAS model is most easily applied to chemicals and e xcludes any of the social aspec ts of ris k tha t mak e risk asse s sment such a co mplex task.

The HAS model

This involves four steps:

1. Hazard Ide ntification 2. Dose-Respon se Assessme nt 3. Expos u re Assessme nt 4. Risk Characterisation

Figure 4.1 sh ows th e NAS model in diagram- matic form .

Figure 4.1: Elements o/n'sk ass essment and management

RESEARCH RISKASSESSMENT RISKMANAGEMENT

LlboJ\ltOlY~M ~e\ll -, DevtlOlll1ltntot

observ~bons01

- I

^{: anl}Iden1,l'caboo

e l

reglollal.ory Opl>Oll5

... _-

(Dces!hll;agentQll5l!

aro;l.rpos.uteSlO !hIl~~etl?)

j

~iWlar"IS

f'4IolaloonolllUbllC

--

:~:m--::,_

I

~Aespgnst~lWlwolis1llorela\lOllShlp

- -- ^...

foI ....'olowdoR ~l~llcMnllflCilllllt.

--

lIl(!aroITIIltol\urIwl

"-

^".~lWhII " Ihoesbma:~

_rceol'llO~

offllCt11'11g,oen

r-'~~

^hPOSu~Assessm"'" IIOPlAnoo?1

"",,,o.lod.l(jlOSurM. (WhaleqlOSures are turrenlly

,

_~

e"'ractflllsahOllot e'rMlIienclldor anloetp,lted

POPUIa~OllS unde,Mte~eood1fOoO(;?) Agency dllCISlons

i!ldscncns

Source,NAS/NRC, 1983