16
Rethinking the role of information in chemicals policy: implications for TSCA and REACH Lars Koch a , Nicholas A. Ashford b, * a Cologne Center for Public Economics, University of Cologne, Germany b Massachusetts Institute of Technology (MIT) (E40-239), 77 Mass Avenue, Cambridge MA 02139, United States Received 20 May 2005; accepted 20 June 2005 Available online 28 September 2005 Abstract This article analyses the role of different kinds of information for minimizing or eliminating the risks due to the production, use, and disposal of chemical substances and contrasts it with present and planned (informational) regulation in the United States and the European Union, respectively. Some commentators who are disillusioned with regulatory approaches have argued that informational tools should supplant mandatory regulatory measures unflatteringly described as ‘‘command and control.’’ Critics of this reformist view are concerned with the lack of technology-innovation forcing that results from informational policies alone. We argue that informational tools can be made more technology inducing e and thus more oriented towards environmental innovations e than they are under cur- rent practices, with or without complementary regulatory mechanisms, although a combination of approaches may yield the best results. The conventional approach to chemicals policy envisions a sequential process that includes three steps of (1) producing or collect- ing risk-relevant information, (2) performing a risk assessment or characterization, followed by (3) risk management practices, often driven by regulation. We argue that such a sequential process is too static, or linear, and spends too many resources on searching for, or generating information about present hazards, in comparison to searching for, and generating information related to safer alter- natives which include input substitution, final product reformulation, and/or process changes. These pollution prevention or cleaner technology approaches are generally acknowledged to be superior to pollution control. We argue that the production of risk infor- mation necessary for risk assessment, on the one hand, and the search for safer alternatives on the other hand, should be approached simultaneously in two parallel quests. Overcoming deficits in hazard-related information and knowledge about risk reduction alter- natives must take place in a more synchronized manner than is currently being practiced. This parallel approach blurs the alleged bright line between risk assessment and risk management, but reflects more closely how regulatory agencies actually approach the regulation of chemicals. These theoretical considerations are interpreted in the context of existing and planned informational tools in the United States and the European Union, respectively. The current political debate in the European Union concerned with reforming chemicals policy and implementing the REACH (Registration, Evaluation and Authorization of Chemicals) system is focused on improving the production and assessment of risk information with regard to existing chemicals, although it also contains some interesting risk management elements. To some extent, REACH mirrors the approach taken in the United States under the Toxics Substances Control Act (TSCA) of 1976. TSCA turned out not to be effectively implemented and provides lessons that should be relevant to REACH. In this context, we discuss the opportunities and limits of existing and planned informational tools for achieving risk reduction. Ó 2005 Elsevier Ltd. All rights reserved. Keywords: Chemicals policy; Chemical regulation; Information; REACH; Risk assessment; Risk management; Testing; TSCA * Corresponding author. Tel./fax: C1 617 253 1664. E-mail addresses: koch@fifo-koeln.de (L. Koch), nashford@ mit.edu (N.A. Ashford). 0959-6526/$ - see front matter Ó 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.jclepro.2005.06.003 Journal of Cleaner Production 14 (2006) 31e46 www.elsevier.com/locate/jclepro

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Page 1: Rethinking the role of information in chemicals policy: implications for TSCA and REACH

Journal of Cleaner Production 14 (2006) 31e46

www.elsevier.com/locate/jclepro

Rethinking the role of information in chemicalspolicy: implications for TSCA and REACH

Lars Koch a, Nicholas A. Ashford b,*

a Cologne Center for Public Economics, University of Cologne, Germanyb Massachusetts Institute of Technology (MIT) (E40-239), 77 Mass Avenue, Cambridge MA 02139, United States

Received 20 May 2005; accepted 20 June 2005

Available online 28 September 2005

Abstract

This article analyses the role of different kinds of information for minimizing or eliminating the risks due to the production, use, anddisposal of chemical substances and contrasts it with present and planned (informational) regulation in the United States and theEuropean Union, respectively. Some commentators who are disillusioned with regulatory approaches have argued that informational

tools should supplantmandatory regulatorymeasures unflatteringly described as ‘‘command and control.’’ Critics of this reformist vieware concernedwith the lack of technology-innovation forcing that results from informational policies alone.Weargue that informationaltools can be made more technology inducinge and thus more oriented towards environmental innovationse than they are under cur-rent practices, with orwithout complementary regulatorymechanisms, although a combination of approachesmay yield the best results.

The conventional approach to chemicals policy envisions a sequential process that includes three steps of (1) producing or collect-ing risk-relevant information, (2) performing a risk assessment or characterization, followed by (3) risk management practices, oftendriven by regulation. We argue that such a sequential process is too static, or linear, and spends too many resources on searching for,

or generating information about present hazards, in comparison to searching for, and generating information related to safer alter-natives which include input substitution, final product reformulation, and/or process changes. These pollution prevention or cleanertechnology approaches are generally acknowledged to be superior to pollution control. We argue that the production of risk infor-

mation necessary for risk assessment, on the one hand, and the search for safer alternatives on the other hand, should be approachedsimultaneously in two parallel quests. Overcoming deficits in hazard-related information and knowledge about risk reduction alter-natives must take place in a more synchronized manner than is currently being practiced. This parallel approach blurs the allegedbright line between risk assessment and risk management, but reflects more closely how regulatory agencies actually approach the

regulation of chemicals.These theoretical considerations are interpreted in the context of existing and planned informational tools in the United States and

the European Union, respectively. The current political debate in the European Union concerned with reforming chemicals policy and

implementing the REACH (Registration, Evaluation and Authorization of Chemicals) system is focused on improving the productionand assessment of risk information with regard to existing chemicals, although it also contains some interesting risk managementelements. To some extent, REACHmirrors the approach taken in the United States under the Toxics Substances Control Act (TSCA)

of 1976. TSCA turned out not to be effectively implemented and provides lessons that should be relevant toREACH. In this context, wediscuss the opportunities and limits of existing and planned informational tools for achieving risk reduction.� 2005 Elsevier Ltd. All rights reserved.

Keywords: Chemicals policy; Chemical regulation; Information; REACH; Risk assessment; Risk management; Testing; TSCA

* Corresponding author. Tel./fax: C1 617 253 1664.

E-mail addresses: [email protected] (L. Koch), nashford@

mit.edu (N.A. Ashford).

0959-6526/$ - see front matter � 2005 Elsevier Ltd. All rights reserved.

doi:10.1016/j.jclepro.2005.06.003

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32 L. Koch, N.A. Ashford / Journal of Cleaner Production 14 (2006) 31e46

1. Introduction

Chemicals are ubiquitous in manifold applications ofour daily life. They have different properties and fulfila wide range of functions. However, apart from their in-tended purposes, many chemicals also have unintendedadverse consequences for human health and the envi-ronment. Thus, the production, use and disposal ofchemical substances are accompanied by ‘‘negative ex-ternalities,’’ expressed as human and environmentalrisks. These risks legitimate and sometimes require gov-ernment action to ensure human and environmentalprotection. For risk management purposes, basic infor-mation is needed about hazards and exposures to poten-tially harmful substances. The acquisition of sufficientknowledge concerning negative effects is necessary toassess and manage risks. Adequate means are also re-quired to force producers and manufacturers to reducerisks in a cost-effective way by adopting or developingbetter safety measures that improve the production pro-cess or substitute less- or non-hazardous substances bysafer alternatives.

Due to the existence of externalities of chemical pro-duction, use, and disposal, informational tools alone,without complementary remediating measures, are notexpected to achieve an internalization of these adverseeffects by the firms.1 Often, additional needed regulatorymeasures are not likely to be created or enforced, andinformational tools2 can at most only partially mitigatethe problems connected with chemicals’ hazards andrisks (see [12]). We focus here on the role of differenttypes of information in chemicals policy either as pre-cedent and complementary to regulatory policy e orto economic-based incentives e or as a self-standingpolicy.

1.1. Types of information

In considering the effects of information on risk re-duction, it is necessary to distinguish between differenttypes of information. The risk management processconventionally includes the three sequential steps of(1) producing or collecting risk-relevant information,(2) performing a risk assessment, followed by (3) riskmanagement practices. The first two steps are necessaryto overcome the problem of informational deficits,

1 In the special case where only the buyer/user of a product is affected

by the hazards of contained substances, informational asymmetries

may exist between seller and buyer, but external effects may be absent.

In this case, it has been argued that informational tools can theoretically

compensate market failures without additional regulatory measures.2 Informational tools have been described as ‘‘the third wave’’ of

environmental policy, following command-and-control and

market-based instruments.

whereas the third step of risk management refers tothe mitigation of the external effects in terms of hazardsand risks.3

Categories of information, which are useful in termsof this process, are scientific information, technologicalinformation, and legal information (see [7, p. 311]). Sci-entific information encompasses (1) product ingredientsand the specific composition of pollution in air, water,soil, and waste, (2) the inherent toxicity and safety haz-ard of the related chemicals, materials, and industrialprocesses, and (3) information related to exposure ofvarious vulnerable groups to harmful substances andprocesses. Technological information includes (1) moni-toring technologies, (2) options for controlling or pre-venting pollution, waste, and chemical accidents, and(3) available substitute inputs, final products, and pro-cesses. Legal information refers to notification of theinformational and other rights and obligations of pro-ducers, employers, consumers, workers, and the generalpublic. Though important, legal information is nota fundamental type of information, but rather the (man-dated) diffusion of information about rights and dutiesstemming from the nature and exposure profiles of haz-ardous substances and processes, and options for theircontrol.

All types of information are potentially helpful inidentifying and reducing the risk of hazardous substan-ces. Knowing the costs, time horizons to acquire infor-mation, and asymmetries in accessing or holding ofinformation by government,4 it is important to focuson the diminishing marginal utility of using resourcesto acquire more information of each type. Moreover,industry and other stakeholders are all importantparticipants in determining how effective different(information) policies might be expected to be in reduc-ing health and environmental risks. Therefore, the appli-cation and usefulness of different kinds of informationin different stages of the risk management process willbe considered.

1.2. The risk management process and problemswith a sequential process

Scientific information basically refers to the twosteps of production and assessment of information con-cerning the identity of, and exposure to, hazards. Pro-duction and assessment of risk information are costly

3 With regard to the large amount of existing chemicals which have

not been adequately tested, an additional step of priority setting

ranked by expected severity is useful. Different ways of priority setting,

as well as their advantages and disadvantages, will not be discussed in

this paper, but see [4].4 For a detailed analysis with regard to the problems of generating

and distributing risk information see [21].

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33L. Koch, N.A. Ashford / Journal of Cleaner Production 14 (2006) 31e46

and time-consuming. Furthermore, there are informa-tion asymmetries between firms and government, aswell as among other stakeholders, because the produc-ing firms are generally acknowledged to have easieraccess to risk information of substances that theyproduce. Thus it is useful and commonplace to requirethe necessary information from the producing firms.Were it not for mandatory requirements, the firmswould have disincentives to produce as well as to dif-fuse information about hazards and risks, becausethis could endanger their production opportunitiesand sales e even though those potentially exposed ex-pect those substances to be safe.5 The correctness andcompleteness of risk information produced by the firmscorrelate directly with the capacity of the governmentor other stakeholders to audit the information. Thisprocess is influenced by two considerations: firstly, itis important to construct regulatory informationalmeasures in such a way that accurate and completerisk information is produced and disclosed. Secondly,the testing requirements for the firms should not un-necessarily burden the production of substances dueto the associated costs of producing those data.

The process of producing risk information is embod-ied in risk assessment: ‘‘a way of ordering, structuringand interpreting existing information with the aim ofcreating a qualitatively new type of information, namelyestimations on the likelihood (or probability) of the oc-currence of adverse effects’’ [24, p. 135]. Risk assessmentinvolves four steps6:

- hazard identification- doseeresponse assessment- exposure assessment- risk characterization

Within the first two steps, existing hazards (e.g., tox-icity, flammability, etc.) of a substance are analyzedand the quantitative relationship between differentlevels of exposure and health/environmental effects isdetermined. The Probable No-Effect Concentration(PNEC) (i.e., the no-effect threshold) or No ObservedAdverse Effect Level (NOAEL) for different exposurepathways and media are identified. However, the rela-tion between dose and (hazardous) response is noteasy to determine. Furthermore, tests for effects onhuman are conducted on animals, which often react

5 To the extent that regulatory requirements impose a responsibility

to disseminate risk-relevant information, rather than to generate infor-

mation, the resulting disincentive to produce useful information could

have serious consequences. See [7, chapter 7].6 See [30].

differently to the same exposure (see [24, p. 139]).Moreover, it is difficult to assess the effects of low ex-posures over a long period of time. This often cannotbe simulated by animal testing with high exposuresover a shorter period. Therefore, long-term and chroniceffects often cannot be accurately predicted. Thus, thedata are usually highly uncertain vis-a-vis human healthrisks.7

Exposure assessment refers to the (temporal) de-scription of the amount and concentration of a sub-stance that is released to different media over time byproduction, use and disposal and that leads to humanand environmental exposure and uptake. From this,the Predicted Environmental Concentration (PEC)and Biologically-Relevant Dose (BRD) are determined.In general, a comprehensive exposure assessment ishardly possible. The final step of risk characteri-zation relates the PNEC to the PEC and BRD, todetermine whether e and to what extent e the expo-sure exceeds the thresholds of different pathways ofexposure and biological action. In this case, risk assess-ment may be followed by risk management, a processthat heroically assumes that a bright line can bedrawn between the assessment of risk and the decisionwhether and to what extent to reduce (i.e., manage)that risk.

However, quantitative risk assessment presents majorchallenges and is e depending on the tests required forrisk assessment for several endpoints e costly andtime-consuming as well. Due to the arguments men-tioned above, a comprehensive risk assessment is prob-lematic. Thus, uncertainty vis-a-vis hazards and risksof substances often cannot be easily overcome by morerisk information and risk assessment. It is also ques-tionable whether better future science can reduce uncer-tainty sufficiently and thereby create a more certainbasis for risk management.8 Uncertainty will also be ag-gravated by the problem of not adequately accountingfor possible combined effects/interactions between dif-ferent substances. In contrast, an initial rough estima-tion of potential risks is often possible, based onreadily-available fundamental information about certainproperties of chemicals. In this case, the analysis ofquantitative StructureeActivity Relationships (SARs)of substances gains significance, because the informationis readily available, is far less expensive, and is predictive

7 See also [23, p. 79] concerning the uncertainty of the data.8 This statement reflects the inherent limitations of risk assessment.

Of course, conducting toxicological or epidemiological studies where

there are little or no prior data does reduce uncertainty to a point.

See [5, 2nd page].

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34 L. Koch, N.A. Ashford / Journal of Cleaner Production 14 (2006) 31e46

of potential hazardousness of substances to someextent.9

It should be noted that due to the character of infor-mation, its value often cannot be known before havingthe information. It cannot be determined in advancewhether e or to what extent e additional testing signif-icantly increases the knowledge of safety or lack of safetyof a substance and thus creates a better decision basisfor the risk management process. In general, the morerisk information that is required, the longer and morecostly the risk assessment is, and the longer it takesbefore risk reductionmeasures can be implemented.How-ever, a comprehensive risk assessment is often requiredin European and American law before regulatory actionlimiting the production, use, or disposal of the productis justified. But the collection of these data neither re-duces risks per se nor stimulates technological innova-tion. Thus, we argue that an overly comprehensive andprotracted risk assessment process may unjustifiably post-pone the implementation of desirable risk reductionmeasures.

1.3. Making the case for a more balanced andsynchronized process

Relevant to the consideration of the timing e or theright moment e for undertaking risk reduction meas-ures are two types of risk management errors one mightmake. A Type I error occurs when a substance is regu-lated which later on turns out to be either not hazardousor less hazardous than expected, whereas a Type II error

9 See, for example, [32]. In 1970s, with the beginning of mandatory

regulation in the United States, for example under the Clean Air Act

and the Occupational Safety and Health Act, knowledge about struc-

tureeactivity relationships e i.e., the relationship between chemical

structure and toxic action e was limited. Substituting a chemical for

which little actual toxicity/epidemiological data existed, for a known

toxic material was very risky. Thirty-five years later, we have accumu-

lated a great deal of experience and our confidence about clearly-safer

substitutes is much more soundly-based. Our chances of unfortunate

surprises are probably greatly diminished. A recent United States Gov-

ernment Accounting Office report stresses the increasing importance of

SARs (see [43]). The report observes: ‘‘.EPA predicts potential expo-

sure levels and toxicity of new chemicals by using scientific models and

by comparing them with chemicals with similar molecular structures

(analogues) for which toxicity information is available.EPA believes

that the models are generally useful as screening tools for identifying

potentially harmful chemicals.EPA believes that, based on limited

validation studies, its models are more likely to identify a false pos-

itive.than a false negative.’’ OECD member countries are currently

leading collaborative efforts to develop and harmonize SAR methods

for assessing chemical hazards.

One further consideration is that our technological options are far

more varied than ‘‘drop-in’’ chemical substitutes. Alternative synthetic

pathways e the focus of ‘‘green chemistry’’ and ‘‘green engineering’’ e

allow us to alter inputs, change final products, and use different pro-

duction methods that eliminate or drastically reduce the probability

of harmful chemical releases and exposures (see [2,3,9]).

occurs when a suspected hazardous substance is not reg-ulated and it turns out to be hazardous or more hazard-ous than expected [5,45]. Undertaking a comprehensiverisk assessment (and delaying in taking a risk man-agement decision) could substantially minimize Type Ierrors, whereas risk management at an early stage ofknowledge about potential risks minimizes the likeli-hood of Type II errors [19].

The avoidance of Type II errors also embodies theprecautionary principle. One formulation of the precau-tionary principle is as follows: ‘‘Where there are threatsof serious and irreversible damage, lack of full scientificcertainty shall not be used as a reason for postponingcost-effective measures to prevent environmental degra-dation.’’10 Thus, essential conditions for applying theprecautionary principle are uncertainty and irreversibil-ity.11 In contrast, avoidance of Type I errors presuppo-ses that a substance is safe, until the opposite has beenshown.

Obviously, the relative merits of making a decisionbetween avoiding a Type I error and a Type II errorreflect a present trade-off based on currently limitedknowledge of the risks of both currently-used technol-ogy and alternative technologies, and can hardly bebased on strictly quantitatively-rational criteria. Theregulatory authorities in the European Union and inthe United States historically have acted to avoidType I as well as Type II errors. The industrial pro-ducers of chemicals are more concerned with avoidingType I errors, especially with regard to existing chem-icals. In this context, a central question to consider iswhether it is possible to decrease the probability ofType II errors, without significantly increasing Type Ierrors by appropriate information-enhancing activities.In this regard, we argue that on the one hand a roughcomparative risk estimation of potential hazards ofalternative technologies (inputs, final products, or pro-cesses) to the technology presenting the putative hazardunder scrutiny is possible with relatively low-cost infor-mation-enhancing activities, while, on the other hand,a comprehensive and costly risk assessment of the pu-tative hazard alone often does not significantly increasethe certainty about risks. Note that comparative assess-ments do not need to entail protracted risk assess-ments, but rather a comparison of alternatives againstcurrently-used technologies. Thus, we argue later thatimposing a requirement for comparative analyses on theproponents of a particular technology is not necessarilya burdensome one.

10 Principle 15 of the Declaration of the 1992 UN Conference on

Environment and Development (the Rio Declaration).11 For an extension of the criteria for the application of the precau-

tionary principle see also [5].

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35L. Koch, N.A. Ashford / Journal of Cleaner Production 14 (2006) 31e46

1.4. Risk management

‘‘[Risk management] attempts to develop a suitableresponse to a hazard, taking into account all relevantregulatory, political, environmental, engineering and so-cial factors which might be relevant.’’12 Risk manage-ment is based on a described scientific risk assessmentas well as upon a socio-economic assessment of alterna-tive measures to reduce risks. The socio-economic riskassessment is incorporated into a special case of costebenefit-analysis and is termed riskebenefit analysis.13

Within these analyses, all relevant costs and benefits ofa risk reduction measure are accounted for e startingfrom a baseline without any regulatory action e andconverted into a single unit (usually money) for compar-ison of both benefits and costs. The consideration be-tween risks and costs for risk reduction is combinedwith several normative decisions within present trade-offs. There is no inherently unique value of risk reduc-tion, but it is always determined by political andsocietal weighting. What is supposed to be a reasonableor unreasonable risk e or an ‘‘acceptable risk’’ e reflectsa normative basis. By converting several costs and ben-efits into a single unit, different normative decisionsmust be made, e.g., evaluating environmental and healthdamages and choosing an adequate discount rate for fu-ture damages. By taking only the social costs and bene-fits into account, distributional effects are often notconsidered. The assumptions that are taken for compen-sating remaining uncertainties with regard to risks andcosts are also of great importance. The problems ofrisk-benefit studies in general and arguments for usinginstead trade-off-analysis, which leaves all costs andbenefits in their original units as well as considers thedistribution of costs and benefits and thus does not ob-scure the present trade-offs of risk reduction measures,are comprehensively discussed elsewhere by one of theauthors (see [4 (p. 70), 5]).

What we emphasize here, instead, is the significanceof examining or obtaining information about the ex-pected costs and risks of risk reduction measures (riskcontrol/reduction technologies, as well as safer alterna-tives) (see [5, p. 5]). When hazards are expected to exist,it is useful to force the search for safer alternatives at anearly stage of the process, instead of undertaking a com-prehensive risk assessment process first.14 This implies

12 See [40].13 Whereas the United States has a tradition of applying costebenefitanalysis before implementing regulatory measures, in Europe the dis-

cussion about a stronger application of costebenefit approaches is

a more recent and an increasingly recommended practice.14 The REACH proposal envisions that EU member regulators will

consider alternatives only after substances are determined not to be

‘‘adequately controlled’’, and the burden of demonstrating the exis-

tence and efficacy of alternatives is on the regulators, not the producer,

although the proponents of substitutes are invited to make their case.

a change from performing an extensive risk assessmentof the putatively hazardous substance to undertakingat an early stage, a comparative risk assessment of knownrisks of other substances and processes is known to becharacterized by recognized safer options and knowncosts15 for their application. This process involves a syn-chronized and iterative process involving the three stepsof risk information production, risk assessment and theselection of risk management options. To illustrate this,different scenarios can be distinguished:

(1) The present substance is either known to be safe orknown to be unsafe in a well-characterized manner:This causes neither a problem with a sequential norwith a more synchronized approach.

(2) The present substance is known to be unsafe but lack-ing important details/characterization:In this case, following a sequential process createscost and time problems. Instead of analyzing thelack of safety in detail, it may be more useful to starta comparative socio-economic risk assessment.Whether to explore alternative solutions dependson the costs and benefits (risk advantages) of variouscontrol options, including but not limited to input orfinal product substitution. On the risk side, if therisks associated with the existing alternatives are un-certain, a determination must be made of whether toundertake a process to (1) further clarify the risks ofthe original substance/chemical, (2) clarify the risksof the existing alternatives or (3) instead to searchfor (or design) clearly-safer alternatives. On the costside, if control or risk reduction is expensive, it maybe very usefule and cost savinge to search for alter-natives, preferably e but not necessarily e at consid-erably cheaper costs that control the original hazard.The necessity for shifting the information activitiesaway from expanding our knowledge about risk eand towards elucidating risk reduction measures andsearch for information about safer alternatives andsubsequent application of known alternatives edepends on the societal costebenefit calculus of thevalues of different kinds of information. Simply put,the strategic question becomes one of whether riskof the original substance/chemical or existing alterna-tives should be further clarified, or new technicaloptions should be explored instead. Even if shifting

15 If the safer alternatives are in existence or use, even if in a minority

of cases, costs will be known. If the safer alternatives still need to be

developed, it could be argued that they could be of unknown cost or

likely to be expensive. History, however, shows that regulations that

force the development of new technologies are three to five times

cheaper than industry alleges [44] and that technology-forcing leads

to many opportunities to modernize production processes that often

yields cost and other savings [6,34,35]. Here, too, absolute cost esti-

mates are not necessary, but rather comparative cost analysis.

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36 L. Koch, N.A. Ashford / Journal of Cleaner Production 14 (2006) 31e46

to an alternative technology (substitute inputs/finalproducts or process changes) is more expensive, itsadoption could be justified because of the greater cer-tainty of lower risks from clearly-safer substitutes.

(3) The hazardous nature of the present substance isuncertain:In this case it is necessary to specify the kind and ex-tent of the uncertainty. Starting from the propertiesof a substance, an assessment of the hazardous po-tential of a substance is fundamental. If a substancecontains hazardous potential, a synchronized pro-cess of further risk assessment, and comparativerisk and cost analyses of substitute technologies, asdescribed under scenario (2) is useful.

Comparative cost and risk assessments in this discus-sion thus mean a rough assessment of costs and risks be-tween (1) continuing present production (or startingproduction) and (2) pursuing future alternatives. Dueto the uncertainties associated with scientific risk assess-ment, the socio-economic-risk assessment could involveeven more uncertainties where not only the risks are un-certain, but so are the costs and effects of risk reductionmeasures.

Given that no Type I error (i.e., regulating a clearlynon-hazardous substance) was [yet] made, and assumingthat new products or processes that are expected to besafer will be developed/identified and applied by thefirms, two types of error can occur in adopting substi-tute technologies. First, the new technology could turnout to be no safer e or even more hazardous than theformer one e (an environmental risk error), and second,the new technology is not able to fulfil the same func-tionality (a technological function error). The substitu-tion of presently existing products and processestherefore could create both future technological and en-vironmental risks. In practice, this could stifle their sub-stitution for hazardous substances. Developing andimplementing alternative products and processes couldbe a difficult process. Both incurring the costs of substi-tution and introducing new risks remain problems.However, depending on the nature of the uncertaintiesof the risks, undertaking comparative risk assessmentson substitutes could be easier (and certainly less contro-versial) in some cases. For example, the substitutescould create smaller toxicological risks, or equivalenttoxicological risks, but not flammability risks associatedwith the original substance/chemical.

Finally, a conventional sequential risk managementprocess postpones risk management measures, butsometimes not by significantly decreasing uncertaintywith regard to the risks of chemical substances. There-fore, it is useful to establish the steps of the risk manage-ment process in a more synchronized way. Instead offirst doing a comprehensive risk assessment of existingchemicals, it may be more reasonable to start the process

of comparative risk assessment and risk managementearlier and thus encourage the development and adop-tion of safer (and cheaper) alternatives. Thus, when haz-ards are expected to exist, the focus does not lieexclusively in revealing all present hazards of a sub-stance, but creating knowledge about future alterna-tives. This means a shift of focus from scientificinformation to technological options information.

Unlike a hazard, risk, or technology assessment, tech-nology options analysis seeks to identify where and whatsuperior technologies could be adopted to eliminate thepossibility, or to dramatically reduce the probability,of pollution and accidental releases.16 Ashford [5]explains:

In order to facilitate pollution prevention or the shift tocleaner technologies, options for technological changemust be articulated and evaluated according to multi-variate criteria, including economic, environmental andhealth/safety factors.[T]rade-off analysis.can beused to document the aspects of the different technologyoptions and, further, it can be used to compare improve-ments that each option might offer over existing techno-logical solutions. The identification of these options andtheir comparison against the technology in use is whatconstitutes Technology Options Analysis (TOA). Horn-stein [25] points out that ‘‘it is against the range of pos-sible solutions that the economist analyzes the efficiencyof existing risk levels’’ and that ‘‘to fashion governmentprograms based on a comparison of existing preferencescan artificially dampen the decision makers’ actual pref-erence for changes were government only creativeenough to develop alternative solutions to problems’’[25].

At first blush, it might appear that TOA is nothing morethan a collection of multivariate impact assessments forexisting industrial technology and alternative options.However, it is possible to bypass extensive cost, environ-mental, health and safety, and other analyses or model-ling by performing comparative analyses of these factors(such as comparative technological performance and rel-ative risk and ecological assessment). Comparative

16 A risk assessment, in practice, is generally limited to an evaluation

of the risks associated with the firm’s established production technol-

ogy and does not include the identification or consideration of alterna-

tive production technologies that may be environmentally-sounder or

inherently-safer than the ones currently being employed. Consequently,

risk assessments tend to emphasize pollution control or secondary

accident prevention and mitigation strategies, which impose engineer-

ing and administrative controls on an existing production technology,

rather than primary prevention strategies, which utilize input substitu-

tion and process redesign to modify a production technology. In con-

trast to a risk assessment, a technology options analysis would expand

the evaluation to include alternative production technologies and

would facilitate the development of primary pollution and accident

prevention strategies.

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37L. Koch, N.A. Ashford / Journal of Cleaner Production 14 (2006) 31e46

analyses are much easier to do than analyses requiringabsolute quantification of variables, are likely to beless sensitive to initial assumptions than, for example,costebenefit analysis, and will enable easier identifica-tion of winewin options. Thus, while encompassinga greater number of technological options than simpletechnology assessment (TA), the actual analysis wouldbe easier and probably more believable.

TOAs can identify technologies used in a majority offirms that might be diffused into greater use, or technol-ogies that might be transferred from one industrial sec-tor to another. In addition, opportunities for technologydevelopment (i.e., innovation) can be identified. Gov-ernment might merely require the firms or industries toundertake a TOA. On the other hand, governmentmight either ‘‘force’’ or assist in the adoption or devel-opment of new technologies. If government takes onthe role of merely assessing (through TA) new technolo-gies that industry itself decided to put forward, it maymiss the opportunity to encourage superior technologi-cal options. Only by requiring firms to undertake TOAs,or undertaking TOAs itself, is government likely tofacilitate major technological change. Both industryand government have to be sufficiently technologicallyliterate to ensure that the TOAs are sophisticated andcomprehensive.

Encouraging technological change may have payoffs, notonly with regard to environmental goals, but also to en-ergy, workplace safety, and other such goals [8]. Becausemany different options might be undertaken, the payoffsare somewhat open-ended. Hence, looking to prioritizedifferent problem areas cannot be the same kind of exer-cise as a risk-assessment-based approach. A fraction ofthe amount of money devoted to a single animal studycould instead yield some rather sophisticated knowledgeconcerning what kinds of technology options exist or arelikely in the future. Expert technical talent in engineeringdesign and product development (through green chemis-try or green engineering) can no doubt produce valuableinformation and identify fruitful areas for investment intechnology development [3,2].

1.5. Informational tools for an orientation towardssafer alternatives

For reaching a more synchronized risk managementprocess, risk reduction measures are needed whichpush firms efforts towards the search for safer alterna-tives at an early stage. Where regulatory tools are notimplemented or enforceable, it is useful to explore thelimits and opportunities of informational tools. As dis-cussed earlier, informational tools can be based on thethree types of information e scientific, technological

and legal information e with different effects. Question-ing the importance of scientific information as a precon-dition for risk management measures has been discussedabove in detail. The availability and the assessment ofscientific information alone does not reduce risks, with-out complementary risk reduction measures. Thus, in-formational tools useful for risk management shouldbe based on technological information as well. Thismainly includes:

(1) Requirements for firms to disclose risk information tothe public. Here, the disclosure refers to the exposureprofiles of produced substances and to their toxicity,flammability etc. Information disclosure creates theopportunity for the public to react and avoid expo-sure to existing hazards and risks by, e.g., changingconsumer behaviour or applying pressure on firms.These can be effective parts of the risk managementprocess, without making risk reduction measuresobligatory for the firms.17 Information regulationcan help lessen the need for more formal regulatoryrisk reduction requirements. Information disclosurecan motivate firms to search for safer alternativesby public or market pressure.18 The effectiveness ofinformation disclosure depends on the informationalvalue for different stakeholders, and their reactionon the information. This is discussed later in the con-text of the Toxic Release Inventory in the UnitedStates.

(2) Requirements for the firms to identify and generatetechnological options to reduce existing risks. This in-formational requirement obligates firms to go be-yond reporting what they have done in the past toreduce risks. A more far-reaching requirement is torequire the firms to focus on future options for de-veloping and implementing safer alternatives. Thiscan take place e.g., by having the firm undertakea technological options analysis. By being requiredto think about alternatives, firms increase their ca-pacities to undertake changes.19

(3) Complementary informational tools include databasesof preferred and disfavoured technologies, as well aslabels for safe or hazardous products (or processes).‘‘Negative’’ lists can increase the pressure on firms,that use these substances (analogous to (1)), whereaspositive lists increase their capacity to substitute haz-ardous substances or processes (analogous to (2)).Although important as well, these tools will not bediscussed here.

17 See [27].18 It has been suggested that increased requirements for risk assess-

ment under REACH may have this effect. See later discussion.19 See later discussion in Sections 2.4 and 2.5 of the effectiveness for

stimulating technological change of different reporting requirements

that divulge cleaner production/pollution prevention practices.

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2. The legal frameworks in the United States and

the European Union

In the first section of this article, it was argued thatimplementing risk management practices at an earlystage, instead of trying first to overcome the existinglack of information concerning the riskiness of chemicalsubstances/processes, could be a more productive ap-proach. Achieving risk management goals using infor-mational tools has been suggested where regulatorymeasures are not implemented or are not likely to beenforced. Therefore, it is useful to distinguish differentinformational tools vis-a-vis their potential to strengthenrisk management. This section describes the strengthsand weaknesses of the legal frameworks in the UnitedStates and the European Union, focussing on informa-tional requirements to collect data on chemical substan-ces as well as to implement risk reduction measures.20

Due to the fact that the restriction or ban of substancesis used only very rarely e although more often in theEuropean Union than in the United States e we willargue that alternative informational tools could compen-sate for the lack of stringent regulatory risk reductionmeasures.21

While in the United States, as well as in the Euro-pean Union, regulations creating testing obligationsfor new chemicals22 were implemented in the seventies,no routine tests were required for chemicals whichwere already on the market e the so called ‘‘existingchemicals’’. The vast majority of the substances onthe market e over 90% e are existing substances[49, p. 11]. Therefore, the different ways of data collec-tion and risk management especially with regard to theexisting chemicals will be highlighted here,23 althoughthe United States and the European Union also differin their legal frameworks for new chemicals. Due tothe fact that European directives have to be imple-mented into the national legal frameworks, there arealso differences between the member states. Notwith-standing these differences, the description here occasion-ally refers to the German implementation of Europeanlaw.

20 See [43] for a comparison of United States European Union, and

Canadian approaches to testing chemicals.21 Here we do not focus on laws that regulate hazardous emissions to

water, air, waste, etc., although these laws are also helpful for reducing

the production, consumption and disposal of hazardous substances.22 These regulations refer to chemicals, which were not regulated

under other acts such as pesticides, nuclear material, food additives,

drugs, cosmetics, alcohol and tobacco.23 There also exist many programs on the national as well as interna-

tional level to overcome the lack of knowledge with regard to existing

chemicals e most of them voluntary e which are not considered here.

2.1. Legal framework in the European Union

The current legal framework for new chemicals in theEuropean union is based on the 6th amendment (issuedin 1979) of the Council Directive 67/548/EEC. Thosesubstances, produced before 1981 had to be registeredin the European Inventory of Existing CommercialChemical Substances (EINECS) without any furthertesting obligations. EINECS contains 100,106 entries.The latest data from the European Commission’s JointResearch Centre [33] indicates that the numbers of sub-stances in the different tonnage categories are as follows:

� 1e10 t/y (tonnes per annum) e 17,500 substances� 10e100 t/y e 4977 substances� 100e1000 t/y e 2641 substances� O1000 t/y e 7204 substances (High Production Vol-ume Chemicals)

Within the implementation of the directive in Ger-many, there was also codified legal possibility for theauthorities to require tests for existing chemicals, incase of supposed hazards. This legal possibility was neverapplied. Instead there was chosen a cooperative way towork up the information deficit with regard to existingchemicals, which will not be discussed here.24 The otherEU member states mostly abandoned work on thisproblem until the promulgation of a joint regulation in1993. The unequal treatment of new and existing chemi-cals is considered as having a negative impact on the in-novation of new chemicals. This is due to the testingcosts for new chemicals, which increases the incentiveto find new applications for existing chemicals insteadof inventing and registering new (and safer) ones.

In 1993, the European Union implemented the Exist-ing Substances Regulation (EC Regulation 93/793) toovercome the lack of knowledge with regard to theproperties (hazards) and uses of existing chemicals.The regulation required some producers, manufacturersand importers to present a base data set for existingchemicals. The deadline for substances produced orused in amounts greater than 1000 t/y was March 23,1994 and for amounts greater than 10 t/y June 4, 1998.On the basis of the data, the European Commission de-veloped four priority lists, which include 141 existinghigh-volume chemicals. For each chemical a memberstate was chosen to be responsible for the risk assess-ment including risk management proposals, on the basisof all available data within the firms about hazards andexposition. Afterwards, the proposals of the memberstates have to be discussed on the European level andchanged where required, until all member states agreewith it [37, p. 60]. Since there were only few incentives

24 For a detailed analysis of this cooperative committee see [28].

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for the firms to provide risk information e and due tothe extensive regulatory procedure of risk assessment eso far only 70 risk assessment reports have been finished[14].25 The risk assessment reports end up with one ofthe following conclusions for each report.

i. There is need for further information and/or testing.ii. There is at present no need for further information

and/or testing or for risk reduction measures beyondthose which are being applied.

iii. There is need for limiting the risks: risk reductionmeasures which are already being applied shall betaken into account.

These conclusions are different for risks for workersand consumers, and are different for health effects ingeneral and environment.

Warhurst [49] provides an assessment of the data onHigh Production Volume (HPV) substances:

In 1999, the ECB analyzed the data it had received fromindustry on the properties of their HPV chemicals [1].This study found that:

� Only 14% of the EU High Production VolumeChemicals had data publicly available at the levelof the base-set;

� 65% had some data but less than base-set;� 21% had no data.

Without this data it was impossible to assess whichchemicals were a priority for further evaluation in theexisting chemicals program, and unclear how industrywas managing to carry out its other responsibilities,such as classification and labelling chemicals and assess-ing risks to workers. As a result of these studies aSwedish government official stated, ‘‘most substanceson the market are in reality not covered by the currentlegislation’’ [13].

The risk assessment reports offer a basis for risk re-duction measures, but they give no advice about howto reduce risks. An evaluation of the regulation showsthat for 34 out of 41 chemicals the reports concludewith either (i) or (iii). Vis-a-vis workers, the reports con-clude in 70% of the cases that further risk reductionmeasures are needed [10, p. 1041]. Comparing the sup-posed risks, which led to the setting on the prioritylist, with the found risks, underestimations have beenapproximately three times more often than instancesof overestimations. Thus, the Type 1 errors e not regu-lating a hazardous substance e has been significantlyhigher than Type 2 errors e regulating a non-hazardous

25 Indeed for 127 substances, there already exists a first draft Risk

Assessment Report.

substance. This strengthens the argument for adoptingrisk reduction measures at an earlier stage of knowledgein the conducting of risk assessment.

The Legal basis for restrictions of new as well as ex-isting chemicals is the Council Directive 76/769/EEC, astransposed into the laws, regulations and administrativeprovisions of the Member States relating to restrictionson the marketing and use of certain dangerous substan-ces and preparations. Whereas the data collection andassessment takes place under the authority of the EUEnvironmental Directorate, the implementation ofrestrictions is under the authority of the EU InternalMarket Directorate. As a consequence, the informationcollected by the first directorate is only partly used asa basis for actions with regard to market restrictions.As a result, most of the few procedures for market re-strictions within the European Union are not initiatedby the European Commission, but by a single memberstate.

In turn, the possibilities for national risk reductionmeasures are restricted due to the European legal frame-work. Before a national implementation, initiatives formarket restrictions have to be reported to the EuropeanCommission. This can be a long process, especially, ifthe Commission decides to aim at restrictions on theEuropean level. For these reasons, market restrictionsfor chemical substances were a very rarely used instru-ment on the national, as well as on the European level.

2.2. Registration, Evaluation and Authorization ofChemicals (REACH)

Since Regulation 93/793 could not resolve the infor-mation deficit because of the slow risk assessment pro-cess,26 the European Commission developed proposalsfor a new regulation, which were published in 2003.27

The political process started with the publication ofthe whitepaper in 2001 focusing on strategies for a futurechemicals policy. The new system is called REACH eRegistration, Evaluation and Authorization of Chemi-cals.28 The main elements are uniform procedures ofregistration and evaluation for new and existing chemi-cals in place until 2012 and the transfer of responsibilityfor producing and assessing data to the industry, as wellas the expansion of responsibilities to the downstreamusers. As for new chemicals, the required data set de-pends on the amount produced annually. Generallythe system is three-tiered. All chemicals produced inhigher amounts than 1 t/y have to be registered without

26 The failure of Regulation 93/793 has been analyzed and discussed

in both scientific and political contexts. For the former, see [50,51];

for the latter, see [15].27 See [17,18].28 See [16].

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any further evaluation (ca. 30,000 substances). A safetyassessment report is necessary for substances producedin amounts over 10 t/y (ca. 15,000 substances). This re-port contains not only data about substances’ propertiesand exposure profiles, but also data about necessary riskreduction measures that need to be taken to assure safeapplication/use from the producer through the down-stream users. A safety data sheet that also contains in-formation about necessary risk reduction measures hasto be passed onto, and if necessary modified, withinthe actors in the supply chain. All substances producedin higher amounts than 100 t/y (ca. 10,000 substances)and the substances which are produced in loweramounts, but are suspected to be hazardous, will beevaluated by the authorities after registration (ca. 5000substances).29

In contrast to the well-defined data requirements forrisk assessment, the responsibility for risk managementis defined only cursorily and superficially in REACH(Article 13, 6)

Any manufacturer or importer shall identify and applythe appropriate measures to adequately control the risksidentified in the chemical safety assessment, and wheresuitable, recommend them in the safety data sheetswhich he supplies in accordance with Article 29.

The function of this risk management element inREACH highly depends on clear definition of ‘‘ade-quate control’’ and sanctions for non-compliance. Thepoint of reference for adequate control seems to be thedetermination and shortfall of the Probable No-EffectConcentration (PNEC) for the environment and theDerived No-Effect Level (DNEL) for human health.30

But so far, the consequences and sanctions31 for an ex-ceeding PNEC and DNEL, respectively, are not quiteclear.32 Moreover, due to the negative incentives for theenterprises to identify risks, control mechanism andsanctions for inadequate registration dossiers are alsoimportant and so far very limited.

Chemicals with certain hazardous properties must beseparately authorized. This includes substances whichcan cause cancer or mutations or are toxic to reproduc-tion (the so called CMR-substances), or are either per-sistent, bioaccumulative and toxic (PBT), or verypersistent and very bioaccumulative (vPvB). For thesesubstances the burden of proof shifts from the

29 The authorities have to evaluate the underlying test plan of an en-

terprise for a substance, whereas other evaluations like completeness

and quality of the registration dossier are optional.30 See REACH, Annex I.31 In REACH, Title XIII sanctions are defined very vaguely.32 Apart from the authorization system, the legal opportunities to

restrict the marketing and use of a substance by the authorities where

essentially adopted from the existing regulatory framework (see

REACH, Title VIII).

authorities to the producers, who are now in charge todemonstrate the safety of a substance to get the autho-rization. The authorization in turn does not automati-cally take place for all, but only for safe applications.In the latest version of the draft law, an authorization(for production and use) is possible, if the risks of anapplication can be ‘‘adequately controlled’’ or if the pro-ducer is able to prove, that the socio-economic benefitexceeds the risks.33 These conditions create wide discre-tion for the authorities.

The main motivation in revising the European chem-icals policy is the past failure in mitigating the informa-tion deficit with regard to the existing chemicals. Despitethe planned changes of the new system, this approachbasically follows the path of first solving the risk infor-mation problem, before risk management can takeplace. Nevertheless, due to the shift of responsibilityfor the risk assessment to the industry this system isargued to be more feasible than the existing regulation.Moreover, the testing demands are more flexible in com-parison to the existing regulation that demands a verycomprehensive risk assessment. Identifying risk reduc-tion measures is also integrated into the responsibilityof the producers and users of chemical substances. Butso far, this responsibility is described only very vaguelyin contrast to the detailed requirements of reportingdata about risk information. To guarantee, that the sys-tem of controlled self-responsibility of industry with re-gard to risk management works, it must be accompaniedby adequate control mechanisms and sanctions. Other-wise, REACH will collect data about risk informationwithout significantly forcing or encouraging risk reduc-tion measures.

In principle, the Authorization system could establisha new form of (regulatory) risk management, on the ba-sis of the reversal of the burden of proof for substanceswith certain properties. The system can be seen as theembodiment of the precautionary principle, becausesubstances are to be screened for their possible potentialeffects and not only because risk has been scientificallyvalidated. How this system will work depends on theform and application of this system by the authorities,but the system has come under criticism [48,49]. Thewide discretion within the authorization system containsthe danger of not making use of the potentially availableprecautionary approach in REACH. As past experienceshows, discretion has often weakened the application ofa regulation in practice (see also Section 2.3). Thus, toensure the application of the precautionary principle,it is important to strengthen its requirements in theauthorization process.

33 However, a decision based on the socio-economic benefit has also

to take into account existing safer alternatives. See REACH, Article

57, 3.

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2.3. The Toxic Substances Control Act (TSCA)

In the United States the Toxic Substances ControlAct was passed in 1976 and confers the EnvironmentalProtection Agency (EPA) manifold rights to requiretesting or reporting activities for new and existing chem-icals and to regulate them.34 The main goals of TSCAare receiving adequate data about the negative effectsof chemical substances and regulating such substances,which present or will present an ‘‘unreasonable risk ofinjury to health or the environment’’.35 Negative im-pacts for the economy and innovation should beavoided by using the ‘‘least burdensome [regulatory]requirements’’.

For new chemicals, a Premarket Manufacturing No-tice (PMN) is required. Thereupon EPA decides ona case-by-case basis if more tests are necessary, butmost often no new testing was required. Existing chem-icals are registered in the ‘‘Inventory of Chemical Sub-stances (ICS)’’, the United States equivalent toEINECS. In contrast to the European union, where dif-ferent inventories for new and existing chemicals exist,the new substances are added to the ICS after the Pre-market Manufacturing Notice (PMN) as well. The ICScontains some 75,000 existing substances [22, p. 153].

Under TSCA, testing for existing chemicals is re-quired by the establishment of testing rules for asmany as 50 chemicals per year following recommenda-tions by the Interagency Testing Committee (ITC). Onthis basis EPA requires tests from industry or EPAhas to justify why tests from their point of view arenot necessary. In practice, a relatively small number ofthose rules were actually promulgated. In the first 15years of TSCA, the ITC proposed tests for 175 chemi-cals to EPA, but EPA thereupon required testing fromindustry for only 25 chemicals. For 34 other chemicals,EPA and industry agreed on voluntary testing, and for 8other chemicals, tests were only proposed [47]. In con-trast to the European attempts to improve the legalframework for existing chemicals, TSCA has notchanged substantially in this regard since its first imple-mentation. However, in the late 1990s, EPA did imple-ment its High Production Volume (HPV) Challenge

34 See [7, 193ff].35 In the early implementation years of TSCA (1976e1980), EPA

adopted a risk-driven approach to existing chemicals by constructing

different classes of chemicals based on production volume and toxicity.

This was seen as a logical necessary first step on the way to efficient

regulation. This allegedly ‘‘rational’’ approach, which consumed

most of the resources of the EPA Office of Toxic Substances, left little

agency resources for actually promulgating regulations. This ultimately

led to an essential failure of TSCA to live up to expectations. A

‘‘death blow’’ was delivered in 1991 by the Fifth Circuit Court of

Appeals in rejecting EPA’s attempt to ban asbestos, perhaps the most

notorious and well-acknowledged carcinogenic chemical substance in

commerce (see Footnote 36).

Program under which chemical companies have begunto voluntarily provide test data on 2800 chemicals pro-duced in amounts greater than 1 million pounds peryear, although they have not agreed to test 300 of thechemicals originally on the HPV list [43].

TSCA also requires the firms to deliver new informa-tion about hazards of the produced substances to EPA.EPA has to be notified of ‘‘significant new uses’’ of reg-istered chemicals, as well. It is within the administrativediscretion of EPA to determine what constitutes signifi-cant new uses. Along the lines of German/Europeanlaw, EPA has also the right to require a toxicity analysisof existing chemicals, if an ‘‘unreasonable risk’’ is sup-posed. The basis for risk reduction measures in TSCAis the existence of an unreasonable risk. It is not the in-tention of TSCA to prevent any risk, but to take into ac-count the benefits as well as risks of a substance. In fact,only few chemicals are restricted by TSCA. Within thefirst 20 years of the passage of TSCA, limitations weredetermined only for 17 substances [47, p. 185]. As of2005, only five chemicals or classes of chemicals: poly-chlorinated biphenyls, fully halogenated chlorofluoroal-kanes, dioxin, asbestos36 and hexavalent chromium wererestricted or banned comprehensively. In conclusion,although the opportunities for the authorities availableto EPA under TSCA are very comprehensive, EPA essen-tially did not use the variety of available options forrequiring data and for minimizing risks in the past. TSCAcould truly be described as a ‘‘paper tiger.’’ Given the

36 The regulation for asbestos was nullified by the Fifth Circuit Court

of Appeals [Corrosion Proof Fittings v. EPA 947 F.2d 1201 (5th

Cir.1991)]. TSCA requires EPA to consider, along with the toxic effects

on human health and the environment, ‘‘the benefits of such sub-

stance[s] and mixture[s] and the availability of substitutes for such

uses.(emphasis added)’’. Because EPA did not explore regulatory

options other than a ban, and more specifically, because EPA did

not evaluate the toxicity (and costs) of likely substitute products in

a search for ‘‘least burdensome requirements’’, the court vacated the

proposed standard and remanded it to EPA for further proceedings.

While arguably the court incorrectly interpreted TSCA’s requirements

as to mandating substitutes’ toxicity (and cost) comparisons e and

could have sought the regulation in another circuit court to give

a more favorable result e the EPA chose not to attempt to reinstate

the asbestos ban, primarily because of the likely extensive burden on

agency resources to perform extensive risk and economic assessments

for substitutes. For all intents and purposes, EPA regards TSCA as

a ‘‘dead letter’’. There is a danger that REACH suffers the same

fate, with the result that regulation (authorization and restrictions) is

not often vigorously pursed. Note, as discussed earlier, that compara-

tive assessment of risks and costs are not nearly as burdensome as con-

ducting separate risk and cost assessments. Whether using comparative

assessment could circumvent the hurdle EPA needs to overcome to sat-

isfy the requirements laid out in Corrosion Proof Fittings needs to be

explored. Because the issue of alternatives needs to be considered in

formulating regulations under TSCA, this may well be possible. In

contrast, because risk assessment seems to drive the REACH process,

and because the consideration of alternatives seems to come in later,

whether the use of comparative analysis in the context of REACH

can circumvent the need for extensive risk analyses is unclear.

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broad regulatory discretion of EU under REACH, thereis a legitimate concern thate although containing differentrisk management elements e it could suffer a similar fate.

2.4. The Toxic Release Inventory (TRI)

In addition to the testing rules for existing chemicals,there are other mechanisms which focus on the publicdisclosure of hazardous expositions in terms of releases,mainly represented by the Toxics Release Inventory(TRI). TRI is part of the federal Emergency Planningand Community Right-to-Know Act (EPCRA), whichwas established in 1986.37 The implementation of EP-CRA can be seen as a reaction of the chemical accidentin Bhopal, India, where several thousand people werekilled and hundred of thousands were injured due toreleases of methyl isocyanate. The main purpose ofEPCRA ‘‘is to inform communities and citizens ofchemical hazards in their areas.’’ EPCRA requires cer-tain industries to announce the releases and transfersof certain chemical substances to air, water, land ortransferred off-site. The data have to be brought in viaa standardized form and are collected by the Environ-mental Protection Agency (EPA) in the Toxics ReleaseInventory (TRI) which is publicly available.38 Theamount of chemicals which are covered has meanwhiledoubled since 1987 to about 650 chemicals.

TRI covers firms that have more than 10 employeesand that produce, manufacture or import over 25,000pounds per year, or use 10,000 pounds per year of thesechemicals. For some persistent, bioaccumulative andtoxic chemicals (PBT) EPA lowered the reportingthresholds in 1999 to 100 pounds, for highly persistentand highly bioaccumulative chemicals to 10 poundsand for dioxin and dioxin-like compounds to 0.1 g [42,p. 1]. All facilities of the manufacturing sector and sev-eral other industries are required to deliver data, thus6100 facilities are charged to report their releases. Alto-gether, approximately 6e7% of all chemical releases aresubject of TRI. Apart from the reporting requirementsfor chemicals releases, EPCRA itself does not includeany other regulatory measures.39 The costs of complying

37 The reporting requirements for TRI can be found in EPCRA, Sec-

tion 313. Apart from TRI, EPCRA also includes three other legislative

parts: emergency planning, emergency release notification, and hazard-

ous chemical storage reporting requirements. See [20].38 The data can be found on EPA’s webpage: http://www.epa.gov/tri/.39 The 1990 Pollution Prevention Act (PPA) represents a stricter

movement from pollution control to pollution prevention. The PPA

augments EPCRA and adds further requirements related to pollution

prevention activities to industrial reporting. Firms are asked to report

source reduction activities they are undertaking and additional data

about their waste management practices. The list of substances

required to be reported as ‘‘releases’’ has also been expanded. Very

few pollution prevention activities have in fact resulted from the

PPA requirements.

with TRI mainly consist in the working hours neededwithin the firms to provide the data. These costs amountabout $475 million a year. For the role for PBT-substan-ces in 2000 the costs are estimated with $147 million inthe first reporting year 2000, and $81.6 in the subsequentyears.40 These costs do not include further indirect costsof TRI for the firms. The administration costs for EPAare estimated as relatively low.

Our assessment of TRI mainly focuses on two issues:(1) whether the TRI-data represent a good indicator offirms’ environmental performance, and (2) whether theTRI-data were treated as if they were a good indicatorof firms’ environmental performance, revealed by thefirms’ direct reaction as well as to reactions of otherstakeholders that resulted in a change of the firms’behaviour.

2.4.1. Limits of TRIThe purpose of TRI is to overcome part of the infor-

mation deficit with regard to the present hazards ofchemicals by informing the public. The potential powerof TRI depends on quality and quantity of the data, aswell as the capacity of the public to understand and in-terpret the data. More available information does notnecessarily mean increased knowledge. ‘‘If informationis not provided in a clear and useable form, it may actu-ally make people less knowledgeable than they werebefore, producing over-reactions, or under-reactions,based on an [in]ability to understand what the informa-tion actually means [38, p. 626].’’

First, considering the quantity of existing chemicalsthat are covered, TRI focuses only on the releases ofchemicals from manufacturing plants and does not in-clude the whole life cycle of a product. Moreover, only6e7% of all releases are covered. A reported reductionin chemical releases does not necessarily mean a total re-duction of releases but could also be a result of shifts inreleases from covered to not covered chemicals. Sincethere is little knowledge vis-a-vis the existing chemicals,it is difficult to estimate whether TRI covers the mosthazardous chemicals. Moreover, the firms are not re-quired to produce risk information about the coveredsubstances, but only have to report their releases. Inaddition, within the covered substances, no difference ismade between the different severity (i.e., health or envi-ronmental consequences) of releases. With regard to thequality of the data, all hazards of the reported chemicalsare equally treated e apart from the recent exception ofthe persistent, bioaccumulative and toxic chemicals. Byonly looking on the total amount of releases, the widelyvarying risks of hazardous substances are not factoredin. No matter which releases were reduced, they were

40 See [36, p. 9].

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all implicitly dealt with as if they were equally hazard-ous. The total decrease in all releases, can neverthelessincrease the releases of more hazardous chemicals andthus increase the total risks [46].

This is also true for different types of releases. A shiftfrom one emission type to another can also cause moreproblems, although the total amount of releases remainsequal or is decreasing. Moreover, TRI does not requirea uniform reporting system, and firms are also allowedto change their reporting system in time. Several exam-ples show that a firm can create paper reductions of sub-stances’ releases by changing the reporting system,although the releases have not decreased. Thus reportedreductions can partly be attributed to changes in report-ing methods [46]. By taking all these limitations of TRIinto account, the potential power of the data is verydoubtful. Neither is it clear that all relevant releasesare covered, nor that the reduction of reported releasesalso means a real decrease in releases on the one handand a decrease in risks due to hazards on the other hand.

2.4.2. Effects of TRIAlthough there are limitations to consider the TRI-

data as a good environmental indicator, the publicationof the data appeared to have an enormous positive im-pact on the reduction of reported releases. During theperiod from 1988 to 2001 on- and off-site releases ofthe core chemicals were reduced by 54.5% while the pro-duction increased. 39.6% of the decrease was alreadyreached by 1995 (EPA [42]). Actually, while emissionsto air and water decreased, there were corresponding in-creases in hazardous waste. Due to the fact that hazard-ous waste may be more problematic than the decreasedemissions, the success of TRI is far from clear.

According to EPA, the TRI-data are widely used bythe industry itself, the government, communities, publicinterest groups, the stock market, insurance companies,consultants, etc. [20]. The data are used to evaluate andimprove firms’ environmental performance, to set pres-sure on firms, to localize further regulatory call for ac-tion, to educate the public about hazards in theirneighbourhoods, etc. Due to the fact that the firms areonly required to report their releases without any furtherregulatory requirements, it is important to explore thefactors that have caused the (reported) reductions.Konar and Cohen [29] show in their study that the stockmarket reacts on unexpected high releases of firms withinthe first publication of TRI-data in 1989 with decrease inabnormal stock value. This does not mean that the worstperforming facilities also experienced the highest stockdecreases, because the stock market could have expectedthat in advance because of reports in the media and there-fore has already reacted [29, p. 13]. But all of the firmswith abnormal stock decreases were in the upper thirdof polluting firms. These firms with the worst stock mar-ket reaction, thereupon decreased their TRI-releases

significantly to a larger extent than the average perform-ing firms. Thus it can be concluded that the stock marketincorporates and evaluates TRI-data as an indicator forenvironmental performance or for the efficiency of firms.Firms with high releases are supposed to be vulnerablewith regard to costs to comply with potential futureenvironmental regulations or are considered not to beorganized efficiently. As a reaction, these firms havea higher incentive to improve their TRI-performancefor being better evaluated by the stock market. It isnot clear if this is more than a one-time effect with an ex-pected decreasing significance in time.

Furthermore, the representation of workers in envi-ronmental management within firms plays an importantrole. The more worker representatives are involved infirms’ decisions, the more the firms tend to reduce thereported releases (see [11, p. 9]). In contrast, there are noempirical findings for a significant influence of the publicto push firms in decreasing their releases (see [31]). How-ever, this could be also due to the difficulties in measur-ing this correlation.

2.5. The Massachusetts Toxics Use Reduction Act(TURA)

The Massachusetts Toxics Use Reduction Act(TURA) was passed in 1989 with the goal to reducethe use of hazardous substances by 50% by 1997(Massachusetts Toxics Use Reduction Institute [41,p.1-1]). ‘‘TURA is a ‘‘planning tool’’ for more efficientindustrial operations that would produce less waste’’[41]. It requires facilities to report their releases of toxicsubstances along the lines of EPCRA. But under TURAover 1400 chemicals are subject to reporting,41 althoughonly 250 of the listed chemicals are relevant forMassachusetts.42 Over 1000 facilities took part in theprogram at the beginning, where today only about600 are left. The others mostly quit using the reportedchemicals [41,27].

In contrast to EPCRA, TURA also contains twoessential extensions: TURA not only requires data aboutchemical releases but also about chemical use. Thus,TURA demands a mass balance of toxic substances forthe whole production process. Furthermore, TURA re-quires facilities ‘‘to undergo a planning process to iden-tify opportunities for toxics use reduction’’ [41, p. 1-1].

41 All of the substances on the federal Toxics Release Inventory (TRI)

under Section 313 of the federal Emergency Planning and Community

Right to Know (EPCRA) are regulated. Also, substances found on the

federal Comprehensive Environmental Response and Compensation

Liability Act (CERCLA) list are subject to TURA reporting and plan-

ning, except for chemicals that are delisted.42 Other states like New Jersey or Oregon have also implemented sim-

ilar mandatory programs, but TURA is seen as the most ambitious.

See [27].

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44 L. Koch, N.A. Ashford / Journal of Cleaner Production 14 (2006) 31e46

While EPCRA requires firms to report only what pollu-tion prevention actions they are currently taking, it callsfirms to focus on future alternatives by asking not onlywhat they have been doing, but also what they could do,to reduce the use and releases of hazardous substances.Firms have to prepare a Toxics Use Reduction Plan toshow how toxic chemicals are used and how they couldbe reduced within the whole life cycle (this is the essenceof Technology Options Analysis):

‘‘Each plan must provide a corporate policy statementand two- and five-year goals for by-product reductionof each listed chemical. In addition, each plan must in-clude information about current and projected toxicchemical use, the technical feasibility of implementingvarious techniques, and the economic impacts of eachtechnique; a description of each technique or procedurethat is to be implemented; and a schedule for implemen-tation’’ [41].

Basic toxic use reduction techniques are: input substi-tution, product reformulation, production unit redesignor modification, production unit modernization and im-proved operation and maintenance [41]. The costs of theregulation between 1990 and 1997 have been estimatedto be $76.6 Million (including fees the firms have topay) according to calculations of the MassachusettsToxics Use Reduction Institute, whereas the benefitsonly for the firms have been savings of $90.5 Million.This sum does not include environmental and healthbenefits (see [41, p. ES-5]).

As a result of including the whole production processof toxic substances and focussing on future options,Massachusetts is seen as the most successful state of theUnited States with regard to reducing use and releasesof toxic substances. Comparable success can be founde.g., in New Jersey, where similar regulations took place.Between 1990 and 2000 the reporting facilities have re-duced the use of toxic substances by 45%, by-productsand waste per unit of products by 69% and releases by92%. Toxics shipped in products were reduced by 60%[41]. Thus, the success of TURA in reducing hazardoussubstances within the whole production process is muchmore far-reaching than for TRI. Furthermore, firmswere able to save money by implementing safer alterna-tives into the production process, thus the costs ofTURA already appear to be exceeded by the benefits.

2.6. TRI and TURA: opportunities and limitations

Despite the limits of the TRI-data, they seem to bewidely recognized as an indicator for firms’ environmen-tal performance. Thereby especially the stock marketand the workers representation have a significant impacton the decrease of the reported firms’ releases. Thus, thedisclosure of hazardous releases can be a potentiallypowerful tool. Therefore, it seems to be useful to

increase the potential power of TRI by improving quan-tity as well as quality of the data (see for example [39]).With regard to the quantity, TURA shows the way byfocusing on the whole production process. Moreover,more firms and substances could be subject to TRI.

Improving the quality of the data means, amongother things, the distinction between the varying degreeof severity of hazardous substances. This is combinedwith increasing complexity for the processing of thedata, as well as the public capacity to interpret thedata. ‘‘However, too much information can producecognitive overload and lower the effectiveness of disclo-sure’’ [39]. It is also important for the quality of the datato establish a unique reporting standard. Otherwisefirms have an incentive to use the reporting standardto reduce their releases on the paper. Basically it is im-portant to ask whether it is possible to create a compre-hensive information system at acceptable costs thatadequately measures different environmental perform-ances of firms. Otherwise it could be useful to focuson other measures to reduce risks. Looking at the actualcosts of TRI, a further extension of its application toother chemicals may not be as useful as other initiatives.

In contrast, the tools implemented by TURA are in-expensive and also cost-effective for the firms. One ofthe key success factors of TURA in this regard e apartfrom the extension of requirements for the delivereddata to the whole production process e was the focuson identifying future technological options to reducehazardous substances. By requiring the firms to make al-ternatives explicit, it increases firms’ capacities to findsolutions to reduce risks and save money at the sametime. Thus, TURA seems to be a successful informationaltool to encourage risk reduction measures. It is arguablethat there are limits to the amount of chemicals a systemlike TURA is able to handle in this comprehensive man-ner. However, if one assumes that the total number ofchemicals that actually present significant toxic expo-sures are of the order of a few thousand or less, theTURA approach could well be sufficient.

3. Conclusions

In this paper we argued for a more synchronized riskmanagement process, as well as for the application of in-formational risk management tools, especially if regula-tory risk management measures are not likely to beenforced. Different kinds of information are useful forall stages of risk management. For existing chemicals,there is both a lack of knowledge about hazards (risk)and a lack of regulatory risk reduction measures. Inthis context, informational tools as a complement ofrisk management, can be helpful to encourage firms toreduce risks. Therefore, the simultaneous promotion offirms’ public disclosure, on the one hand, and capacity

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45L. Koch, N.A. Ashford / Journal of Cleaner Production 14 (2006) 31e46

building by drawing their attention to future options, onthe other hand, as applied in Massachusetts seems to bea promising approach. In particular, learning fromTURA could help to force the planned risk managementelements under REACH.

In contrast, the European reorganization of chemi-cals policy continues to focus on a solution drivenmainly by addressing the lack of knowledge about riskwith regard to the existing chemicals. The essential fail-ure of TSCA in the United States should awaken the EUauthorities to the possibilities of a similar result. Indeedthere are some important novel elements of REACH,e.g., the responsibility shift from the authorities to theindustry and the integration of identification of risk re-duction measures in the safety assessment report; andthe authorization system could possibly offer a promis-ing tool with regard to the improvement of risk manage-ment. But to be effective, these elements highly dependupon aggressive interpretation and implementation bythe EU. If this turns out not to be the case, it is very likelythat REACH will mainly result in the collection of dataabout risk, and the risk reduction opportunities will re-main greatly underutilized.

In finalizing REACH, serious consideration shouldbe given to replacing the sequential process involvingthe production of risk assessment data and analysis,followed by authorization, by a more synchronized anditerative process. The production of risk informationnecessary for risk assessment, on the one hand, andthe search for safer alternatives on the other hand,should be approached simultaneously in two parallelquests. Overcoming deficits in hazard-related informa-tion and knowledge about risk reduction alternativesmust take place in a more synchronized manner thanis implicit in REACH.

Acknowledgments

The authors are indebted to the following who cri-tiqued earlier versions of this paper: Paul Anastas,Michael Warhurst, Nicolas Sadeleer, and Gerd Winter.The authors, of course, are responsible for the final paper.

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