Scientific advice, innovation and the Precautionary Principle

October 29, 2014 at 12:42 pm | Posted in H&E Features | Leave a comment
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Innovation, precaution or both?

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While unambiguous scientific advice in areas of political and scientific controversy is appealing, in reality it is probably unattainable. There is therefore a need for extra-informational decision-making mechanisms, of which the Precautionary and Innovation Principles are two examples. Often seen as existing in opposition, in the right policy environment precaution exists in unison with innovation. Furthermore, benefits of an Innovation Principle may be overstated due to underestimation of the cost of failure to anticipate potential harm and society’s ability to solve the challenges of implementing precautionary approaches to chemical risk management.

Scientific Advice

Although there is a conventional wisdom that science clarifies, the truth of the matter 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 possible 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, unambiguous scientific advice is understandable, the possibility that science may make controversies worse renders this approach highly problematic. (It is an unfortunate irony that scientific advice in fact becomes most problematic in the very areas it is most highly prized and therefore most sought-after: issues such as fracking, stem cell research, climate policy, genetic engineering, chemicals policy and so forth.)

If scientists are unlikely to give politicians the whole truth they may be seeking, because scientific input in combination with other social determinants of policy-making can produce runaway complexity at least as often as it resolves debate, it means we cannot expect to solve our problems simply by doing more research or getting more advice (note this does not amount to saying that advice should not be sought).

In turn, this means we need mechanisms 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.

Extra-Informational Decision-Making

So far, so esoteric. The purpose of these reflections is to draw attention to the possibility of necessary uncertainty in decision-making and a subsequent requirement for extra-informational decision-making mechanisms, because this gives us a lens through which to view the Precautionary Principle and its perceived competitive partner, the Innovation Principle, with regard to chemicals policy.

In a system operating under conditions of uncertainty, there are inevitably going to be mistakes made about which chemicals are safe for market and which are not. It follows that there is a decision to be made as to whether one takes a relaxed 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 prevent from coming to market products which could well have been safe.

The former represents the historic laissez-faire approach to chemical regulation, while the latter represents the modernised 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 modernised 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 current trends in chemical policy are too precautionary 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 precautionary 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 opposition 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 animal feed, pesticides and many other well-studied agents (Harremoës et al. eds. 2002; Gee et al. eds. 2013): whatever it is we think we know now about safe exposure levels or environmental distribution of a compound, in future the levels will reduce and information about distribution will lead to exposure being more rather than less problematic.

Since this is a function of the way knowledge develops over time, rather than a function of interpretation of information which is accessible at the point of decision-making, this suggests that estimates of cost/benefit trade-offs need to be approached cautiously by decision-makers, as there is a risk that relative benefit 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, leaded petrol or asbestos and acting to encourage adoption of alternatives would really have been anti-innovative, or if instead it would simply have brought forward (in some cases by several decades) the safer innovations that finally emerged, producing the same beneficial result without 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 longevity 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 products may in fact benefit chemical producers and downstream users by reducing the risk of later market rejection.

This type of risk exposure is being taken increasingly seriously by sustainable investment 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 number of market actors for guidance on chemical substitution, but also that researchers and the marketplace can render tractable the problem of selecting safer chemicals.

Fourthly, this transition can be facilitated 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; Ashford & Hall 2011) and the Late Lessons project, it need not be assumed that such regulations will stymie rather than stimulate innovation. Indeed, the notion that regulation can drive innovation has been embraced in the establishment of California’s Green Chemistry Initiative (Wilson & Schwarzman 2009b) and is a rationale which continues to inform Californian chemicals policy today (Raphael 2014).

5 Reasons for Regs

Fifthly, there is recognition that a wholesale transition to safer materials requires the appropriate policy and economic 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 environmental risk would increase the capacity of the chemical industry to innovate in line with regulatory strategies aimed at reducing risks to health posed by chemical 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 potential endocrine disruptors early in the product development phase (Schug et al. 2012) and is being field-tested with private 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 extra-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 environment and nurtured by investment in green chemistry, need not be interpreted as anti-innovation but actually gives society more of the sort of innovation it needs and less of the innovation it does not, by opening up new high-skill business opportunities while lowering the burden which modern society’s use of chemicals has historically placed on public and environmental health.

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

Bibliography

Ambec, S.; Cohen, M. A.; Elgie, S.; Lanoie, P., 2013, The Porter Hypothesis at 20: Can Environmental Regulation Enhance Innovation and Competitiveness? In Review of Environmental Economics and Policy 7 (1), pp. 2–22. DOI: 10.1093/reep/res016.

Ashford, N., Heaton, G.R., Priest, W. C., 1979, ‘Environmental health and safety regulations and technological innovation’, in: Hill. C. T. and Utterback, J. M. (eds), Technological innovation for a dynamic economy, Pergamon Press, NY.

Ashford, N.A. and Hall, R.P., 2011, ‘The importance of regulation-induced innovation for sustainable development’, Sustainability, (3/1) 270–292.

Beloe, S., 2014, A sustainable investor’s view on the chemicals sector. Presentation at SINnovation, 8 October 2014, Brussels.

Birnbaum LS. Designing safer chemicals. Environ Health Perspect. 2013 Jan;121(1):A9. doi: 10.1289/ehp.1206349. PubMed PMID: 23287533; PubMed Central PMCID: PMC3553447.

Commission of the European Communities, 2000, ‘Communication from the Commission on the Precautionary 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. José Manuel Barroso. The Innovation Principle, Stimulating Economic Recovery’. Brussels.

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 Research on the Potential Hazards of Emerging Technologies: A Case of Myopia and Inertia?” Journal of Epidemiology & Community Health 68 (9): 890–95. doi:10.1136/jech-2014-204019.

Harremoës, P. et al. (eds)., 2002, Late lessons from early warnings: the precautionary principle 1896-2000. European Environment Agency, Copenhagen.

National Research Council (US) Chemical Sciences Roundtable; Anastas P, Wood-Black F, Masciangioli T, et al., editors., 2007. Exploring Opportunities in Green Chemistry and Engineering Education: A Workshop Summary to the Chemical Sciences Roundtable. Washington (DC): National Academies Press (US);

National Research Council (US) Committee on the Design and Evaluation of Safer Chemical Substitutions. 2014. A Framework to Guide Selection of Chemical Alternatives. National Academies Press (US).

Pielke, Roger A., 2007, The honest broker. Making sense of science in policy and politics. Cambridge, New York: Cambridge University Press.

Porter, M. and van der Linde, C., 1995, ‘Toward a New Conception of the Environment‑Competitiveness Relationship’, Journal of Economic Perspectives, (9/4) 97–118.

Raphael, D. 2014. Regulation as the “Mother of Innovation”: Stories from California. Presentation at SINnovation, 8 October 2014, Brussels.

Sarewitz, D., 2004, How science makes environmental controversies worse. In Environmental Science & Policy 7 (5), pp. 385–403. DOI: 10.1016/j.envsci.2004.06.001.

Schug TT, Abagyan R, Blumberg B, Collins TJ, Crews D, DeFur PL, et al. 2012. Designing endocrine disruption out of the next generation of chemicals. Green Chem; doi:10.1039/c2gc35055f

Wilson MP, Schwarzman MR. 2009a. Toward a New U.S. Chemicals Policy: Rebuilding the Foundation to Advance New Science, Green Chemistry, and Environmental Health. Environ Health Perspect 117:1202–1209. DOI: 10.1289/ehp.0800404

Wilson MP, Schwarzman MR. 2009b. Green Chemistry: Wilson and Schwarzman Respond. Environ Health Perspect 117. DOI:10.1289/ehp.0900835R

Green chemistry as leadership opportunity; BPA and behavioural abnormalities in mice; and more // October 2014 science digest #2 (non-human & policy)

October 16, 2014 at 2:46 pm | Posted in 5&5 News & Science | Leave a comment
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October 2014 Science Digest #2:
Non-Human and Policy Research

Green chemistry | Green Chemistry as a Leadership Opportunity for Toxicology: We Must Take the Wheel. Imagine how great it would be to be invited by Ferrari, Mercedes, or Tesla to help design their next new car. From the steering wheel to the engine, sound system, cup holders, and everything else, you would able to have everything just how you want it. Then you could have the best car builders in the world produce what you have helped them design. For a car enthusiast, it would perhaps be a dream come true, but what if you are not into cars? What if your interests lean more toward the scientific and you are more into, say, chemicals? (Tox Sci)

BPA, behavioural abnormalities | Bisphenol-A exposures and behavioural aberrations: Median and linear spline and meta-regression analyses of 12 toxicity studies in rodents. Exposures to bisphenol-A, a weak estrogenic chemical, largely used for the production of plastic containers, can affect the rodent behaviour. Thus, we examined the relationships between bisphenol-A and the anxiety-like behaviour, spatial skills, and aggressiveness, in 12 toxicity studies of rodent offspring from females orally exposed to bisphenol-A, while pregnant and/or lactating, by median and linear splines analyses. Overall, our study showed that developmental exposures to low-doses of bisphenol-A, e.g. ≤120μg/day, were associated to behavioural aberrations in offspring. (Toxicology)

Phthalates, diabetes | Phthalate exposure in utero causes epigenetic changes and impairs insulin signalling. These findings indicate that gestational DEHP exposure predisposes F1 offspring to glucometabolic dysfunction at adulthood by down-regulating the expression of critical genes involved in the insulin signalling pathway. Furthermore, DEHP-induced epigenetic alterations in Glut4 appear to play a significant role in disposition towards this metabolic abnormality. (J Endocrinol)

Epigenetics | The lure of the epigenome. The assertion that multiple mechanisms of inheritance exist, and that variation in genomic sequences alone cannot account for phenotypic differences, inevitably raises ontological concerns similar to those apparent in the days of Lamarck. If the gene is no longer understood as the fundamental force of human life and is not “part physicist’s atom and part Plato’s soul”, as the philosopher of science Evelyn Fox Keller put it, then the hoary problem of the relationship of nature and nurture must once again be confronted. (The Lancet)

Air pollution and stroke; pesticides and depression; and more // October 2014 Science Digest #1 (human studies)

October 15, 2014 at 1:23 pm | Posted in 5&5 News & Science | Leave a comment
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October 2014 Science Digest #1:
Human Studies

Air pollution, stroke | Long-Term Exposure to Ambient Air Pollution and Incidence of Cerebrovascular Events: Results from 11 European Cohorts within the ESCAPE Project. A 5-μg/m3 increase in annual PM2.5 exposure was associated with 19% increased risk of incident stroke [hazard ratio (HR) = 1.19, 95% CI: 0.88, 1.62]. Similar findings were obtained for PM10. The results were robust to adjustment for an extensive list of cardiovascular risk factors and noise co-exposure.

Other recently-published epidemiological studies looking at the effects of air pollution on health:

Pesticides, depression | Pesticide Exposure and Depression among Male Private Pesticide Applicators in the Agricultural Health Study. After weighting for potential confounders, the fumigants aluminum phosphide and ethylene dibromide; the phenoxy herbicide (2,4,5-trichlorophenoxy)acetic acid (2,4,5-T); the organochlorine insecticide dieldrin; and the organophosphate insecticides diazinon, malathion, and parathion were all positively associated with depression in each case group, with ORs between 1.1 and 1.9.

Phthalate exposure in infants | A Longitudinal Study of Urinary Phthalate Excretion in 58 Full-Term and 67 Preterm Infants from Birth through 14 Months. Most PT infants and approximately one-third of healthy FT newborns were exposed to phthalates during early life at a potentially harmful level according to the European Food Safety Authority’s recommended limits of daily exposure.

Phthalates, asthma | Asthma in Inner-City Children at 5–11 Years of Age and Prenatal Exposure to Phthalates: The Columbia Center for Children’s Environmental Health Cohort. Prenatal exposure to BBzP and DnBP may increase the risk of asthma among inner-city children. However, because this is the first such finding, results require replication.

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