3
While unambiguous scienfic advice in areas of polical and scienfic controversy is appealing, in reality it is probably un- aainable. There is therefore a need for extra-informaonal decision-making mechanisms, of which the Precauonary and Innovaon Principles are examples. Oſten seen as being in op- posion, in the right policy environment precauon exists in unison with innovaon. Furthermore, benefits of an Innovaon Principle may be overstated due to underesmaon of both the cost of failure to ancipate potenal harm and of society’s abil- ity to solve the challenges of implemenng precauonary ap- proaches to chemical risk management. Innovation, precaution or both? ANALYSIS OF EMERGING ISSUES IN TOXICOLOGY AND CHEMICALS POLICY RESEARCH ISSUE #76B OCT. 2014 A PUBLICATION OF THE CANCER PREVENTION AND EDUCATION SOCIETY Health and Environment by the Cancer Prevenon and Educaon Society (CPES) is licensed under a Creave Commons Aribuon-Non- Commercial-Share Alike 3.0 UK: England & Wales License. H&E was jointly created by CPES & Health Care Without Harm Europe (HCWHE) in 2009 and moved to be the sole publicaon of CPES in January 2010. CPES gratefully acknowledges all the work done by HCWHE in creang H&E and for agreeing that CPES should take over its producon and distribuon in 2010 and beyond. The Cancer Prevenon and Educaon Society is a Charity (No. 1089082) & Company Limited by Guarantee (No. 4157505). Regis- tered in England and Wales. Registered Office: The Cancer Prevenon & Educaon Society, Meads House, Leighterton, Tetbury, Gloucester- shire, GL8 8UW. Editorial contact details Paul Whaley (editor) [email protected] Although there is a conventional wisdom that science clarifies, the truth of the mat- ter may instead be that the more expert scientists you add to a debate the more complex and confusing it becomes. In fact, if scientists are brought in because there is societal disagreement about the policy which ought to be enacted or uncertainty about the evidence supporting it, it is pos- sible their contributions will exacerbate rather than resolve the complexity and confusion (e.g. Sarewitz 2004; Pielke Jr 2007). This makes policy-makers’ work very difficult. While the need for clear, unam- biguous scientific advice is understanda- ble, the possibility that science may make controversies worse renders this ap- proach highly problematic. (It is an unfor- tunate irony that scientific advice in fact becomes most problematic in the very areas it is most highly prized and there- fore most sought-after: issues such as fracking, stem cell research, climate poli- cy, genetic engineering, chemicals policy and so forth.) If scientists are unlikely to give politi- cians the whole truth they may be seek- ing, because scientific input in combina- tion with other social determinants of policy-making can produce runaway com- plexity at least as often as it resolves de- bate, it means we cannot expect to solve our problems simply by doing more re- search or getting more advice (note this does not amount to saying that advice should not be sought). In turn, this means we need mecha- nisms which cut through complexity and produce democratic policy decisions which give society more of what it wants and less of what it does not, which do not simply hinge on adding information to the system. Image: DodgertonSkillhause / morgueFile

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Page 1: ANALYSIS OF EMERGING ISSUES IN TOXICOLOGY ISSUE #76B … · 2014-10-10 · 4. Regulation creates pressure that motivates innovation and progress. 5. Regulation levels the transitional

While unambiguous scientific advice in areas of political and scientific controversy is appealing, in reality it is probably un-

attainable. There is therefore a need for extra-informational

decision-making mechanisms, of which the Precautionary and

Innovation Principles are examples. Often seen as being in op-

position, in the right policy environment precaution exists in unison with innovation. Furthermore, benefits of an Innovation

Principle may be overstated due to underestimation of both the

cost of failure to anticipate potential harm and of society’s abil-

ity to solve the challenges of implementing precautionary ap-proaches to chemical risk management.

Innovation, precaution or both?

ANALYSIS OF EMERGING ISSUES IN TOXICOLOGY AND CHEMICALS POLICY RESEARCH

ISSUE #76B OCT. 2014

A PUBLICATION OF THE CANCER PREVENTION AND EDUCATION SOCIETY

Health and Environment by the Cancer Prevention and Education Society (CPES) is licensed under a Creative Commons Attribution-Non-

Commercial-Share Alike 3.0 UK: England & Wales License.

H&E was jointly created by CPES & Health Care Without Harm Europe

(HCWHE) in 2009 and moved to be the sole publication of CPES in

January 2010. CPES gratefully acknowledges all the work done by HCWHE in creating H&E and for agreeing that CPES should take over its

production and distribution in 2010 and beyond.

The Cancer Prevention and Education Society is a Charity (No. 1089082) & Company Limited by Guarantee (No. 4157505). Regis-

tered in England and Wales. Registered Office: The Cancer Prevention

& Education Society, Meads House, Leighterton, Tetbury, Gloucester-

shire, GL8 8UW.

Editorial contact details Paul Whaley (editor)

[email protected]

Although there is a conventional wisdom that science clarifies, the truth of the mat-

ter may instead be that the more expert

scientists you add to a debate the more complex and confusing it becomes. In fact, if scientists are brought in because there

is societal disagreement about the policy

which ought to be enacted or uncertainty about the evidence supporting it, it is pos-

sible their contributions will exacerbate

rather than resolve the complexity and confusion (e.g. Sarewitz 2004; Pielke Jr 2007).

This makes policy-makers’ work very difficult. While the need for clear, unam-biguous scientific advice is understanda-

ble, the possibility that science may make controversies worse renders this ap-proach highly problematic. (It is an unfor-

tunate irony that scientific advice in fact

becomes most problematic in the very areas it is most highly prized and there-

fore most sought-after: issues such as

fracking, stem cell research, climate poli-cy, genetic engineering, chemicals policy and so forth.)

If scientists are unlikely to give politi-

cians the whole truth they may be seek-ing, because scientific input in combina-

tion with other social determinants of

policy-making can produce runaway com-plexity at least as often as it resolves de-

bate, it means we cannot expect to solve our problems simply by doing more re-

search or getting more advice (note this

does not amount to saying that advice should not be sought). In turn, this means we need mecha-

nisms which cut through complexity and

produce democratic policy decisions which give society more of what it wants

and less of what it does not, which do not

simply hinge on adding information to the system.

Image: DodgertonSkillhause / morgueFile

Page 2: ANALYSIS OF EMERGING ISSUES IN TOXICOLOGY ISSUE #76B … · 2014-10-10 · 4. Regulation creates pressure that motivates innovation and progress. 5. Regulation levels the transitional

Extra-Informational Decision-Making So far, so esoteric. The purpose of these reflections is to draw attention to the pos-sibility of necessary uncertainty in deci-

sion-making and a subsequent require-

ment for extra-informational decision-making mechanisms, because this gives us a lens through which to view the Pre-

cautionary Principle and its perceived competitive partner, the Innovation Prin-ciple, with regard to chemicals policy.

In a system operating under conditions of uncertainty, there are inevitably going to be mistakes made about which chemi-

cals are safe for market and which are not. It follows that there is a decision to be made as to whether one takes a re-

laxed regulatory approach which allows

products to market which may later end up proving to be harmful, or if one sets more stringent safety data requirements

prior to market approval, which may pre-vent from coming to market products which could well have been safe.

The former represents the historic lais-sez-faire approach to chemical regulation, while the latter represents the modern-

ised and more precautionary approach to

chemical regulation which (for example) REACH is supposed to effect in the EU.

The Precautionary Principle (PP) is the

legal instrument developed to allow mod-ernised approaches to be implemented, as

it enables policy-makers to restrict the use of chemicals when there are

“reasonable grounds for concern” about

their effects on the environment and health but there is uncertainty about the

nature and magnitude of those effects (European Commission 2000).

There is a vigorous and on-going debate

over which of the historic and modern approaches to chemical regulation is most

beneficial to society. Some argue that cur-rent trends in chemical policy are too pre-

cautionary and that regulatory schemes

such as REACH are stifling innovation, job creation and economic growth because of excess concerns about potential harms to

health posed by chemicals, and that an

Innovation Principle should be preferred or at least applied as a brake on precau-

tionary policy (European Risk Forum

2013; Cookson 2013). Others dispute the truth of the premises

on which the innovation vs. precaution

debate is based, arguing that the opposi-tion between precaution and innovation is largely illusory and society can, in the

right circumstances, help itself to both. The question is: how so?

Eating Our Cake and Having It Firstly, there is the observation that both the nature and extent of harm from many

chemical, pharmaceutical and physical

agents tends to be under- rather than over-estimated, as documented in the

European Environment Agency’s “Late

Lessons” case studies of lead, asbestos, PCBs, CFCs, DES, BSE, antibiotics in ani-

mal feed, pesticides and many other well-

studied agents (Harremoe s et al. eds. 2002; Gee et al. eds. 2013): whatever it is we think we know now about safe expo-

sure levels or environmental distribution

of a compound, in future the levels will reduce and information about distribu-

tion will lead to exposure being more ra-

ther than less problematic. Since this is a function of the way

knowledge develops over time, rather

than a function of interpretation of infor-mation which is accessible at the point of decision-making, this suggests that esti-

mates of cost/benefit trade-offs need to

be approached cautiously by decision-makers, as there is a risk that relative ben-

efit will be systematically overstated in

any such calculation, and no amount of examination of currently available data can fully ameliorate that risk.

Secondly, there is a question as to

whether or not acting earlier on emerging evidence of harm from, for example, lead-

ed petrol or asbestos and acting to en-

courage adoption of alternatives would really have been anti-innovative, or if in-

stead it would simply have brought for-

ward (in some cases by several decades) the safer innovations that finally emerged, producing the same beneficial result with-

out the interim period of damage to the environment and associated health costs. Thirdly, there is the observation that

investment in innovation currently vastly favours product function while neglecting other important risk factors in the longev-

ity of the product’s market lifecycle, in particular the health or environmental impact of the product (Hansen & Gee 2014). Thus, encouraging investment in

anticipating hazards from emerging prod-ucts may in fact benefit chemical produc-ers and downstream users by reducing

the risk of later market rejection. This type of risk exposure is being taken

increasingly seriously by sustainable in-

vestment funds such as the WHEB Group

(Beloe 2014). Reduction of such risk is being facilitated by initiatives such as the

GreenScreen and the US National Research

Council’s framework on the selection of chemical alternatives (National Research

Council 2014). These responses suggest

not only a perceived need among a num-ber of market actors for guidance on chemical substitution, but also that re-

searchers and the marketplace can render

tractable the problem of selecting safer chemicals.

Fourthly, this transition can be facilitat-

ed by well-designed environmental taxes and regulations which create the space for

innovation by encouraging investment in

aspects of product performance which have previously been undervalued

(Wilson & Schwarzman 2009a). As argued by research from Harvard Business School

(e.g. Porter & van der Linde 1995; Ambec

et al. 2011), MIT (e.g. Ashford 1979; Ash-ford & Hall 2011) and the Late Lessons

project, it need not be assumed that such regulations will stymie rather than stimu-

late innovation. Indeed, the notion that

regulation can drive innovation has been embraced in the establishment of Califor-

nia’s Green Chemistry Initiative (Wilson &

Five Arguments for Regulation Porter and van der Linde’s five reasons why well-crafted regulation may lead to “innovation offsets” that will not only improve environmental performance but par-

tially or even fully offset the additional cost of regulation. (Ambec et al. 2013) 1. Regulation signals companies about likely resource inefficiencies and potential

technological improvements. 2. Regulation focused on information gathering can achieve major benefits by raising

corporate awareness.

3. Regulation reduces the uncertainty that investments to address the environment

will be valuable. 4. Regulation creates pressure that motivates innovation and progress. 5. Regulation levels the transitional playing field. During the transition period to

innovation-based solutions, regulation ensures that one company cannot oppor-tunistically gain position by avoiding environmental investments.

Page 3: ANALYSIS OF EMERGING ISSUES IN TOXICOLOGY ISSUE #76B … · 2014-10-10 · 4. Regulation creates pressure that motivates innovation and progress. 5. Regulation levels the transitional

Schwarzman 2009b) and is a rationale which continues to inform Californian

chemicals policy today (Raphael 2014).

Fifthly, there is recognition that a wholesale transition to safer materials requires the appropriate policy and eco-

nomic underpinnings, going hand-in-hand

with investment and education in green chemistry (e.g. National Research Council

2007). Access to university graduates

with skills in designing chemicals which are not only useful but pose lower envi-

ronmental risk would increase the capaci-

ty of the chemical industry to innovate in line with regulatory strategies aimed at reducing risks to health posed by chemi-

cal products. Finally, there is the argument that while

precautionary approaches to chemicals

policy do demand more information about products before they are brought to

market, this itself is not necessarily a bad thing. For example, it can open up new

opportunities for SMEs to do high-skill

laboratory work: the TiPED tool is a lab-base screening tool for identifying poten-tial endocrine disruptors early in the

product development phase (Schug et al.

2012) and is being field-tested with pri-vate companies (Birnbaum 2013).

Conclusion The point of this piece is to argue that

the Precautionary Principle is one way of

meeting society’s requirement for an ex-tra-informational mechanism for making

decisions in developing chemicals policy.

A potential alternative is the Innovation Principle; however, there is an argument

to be made that precautionary policy, if

implemented in the right research envi-ronment and nurtured by investment in

green chemistry, need not be interpreted as anti-innovation but actually gives soci-

ety more of the sort of innovation it needs

and less of the innovation it does not, by opening up new high-skill business oppor-tunities while lowering the burden which

modern society’s use of chemicals has

historically placed on public and environ-mental health.

With thanks to David Gee for clarifications and contribution of references.

HEALTH AND ENVIRONMENT ON-LINE: WWW.HEALTHANDENVIRONMENTONLINE.COM VISIT FOR NEWS AND RESEARCH BULLETINS. SIGN UP TO RECEIVE H&E IN YOUR INBOX.

Ambec, S.; Cohen, M. A.; Elgie, S.; Lanoie, P., 2013, The Porter

Hypothesis at 20: Can Env ironmental Regulation Enhance

Innovation and Competitiveness? In Review of Environ-mental Economics and Policy 7 (1), pp. 2–22. DOI: 10.1093/

reep/re s016.

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health and safety regulations and technological innovation',

in: Hill. C. T. and Utterback, J. M. (eds), Technological inno-

vation for a dynamic economy, Pergamon Press, NY.

Ashford, N.A. and Hall, R.P., 2011, 'The importance of regula-

tion-induced innovation for sustainable deve lopment',

Sustainabil ity, (3/1) 270–292.

Beloe, S., 2014, A sustainable investor’ s view on the chemicals

sector. Presentation at SINnovation, 8 October 2014, Brus-

sels.

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Perspect. 2013 Jan;121(1):A9. doi: 10.1289/ehp.1206349.

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ary Principle’. Brussels.

Cookson, C., 2013, ‘Government in danger of stifling bright

ideas’, Financial Times, 17 October 2013.

European Risk Forum, 2013, ‘Open letter to Mr. Jose Manuel

Barroso. The Innovation Principle, Stimulating Economic

Recovery’. Brusse ls. Gee, D. et al. (eds)., 2013, Late lessons from early warnings:

science, precaution, innovation. European Environment

Agency, Copenhagen.

Hansen, S. F., and D. Gee. 2014. “Adequate and Anticipatory

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gies: A Case of Myopia and Ine rtia?” Journal of Epidemiolo-

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an Environment Agency, Copenhagen.

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