The Underlying Foundation of Science Used in the Regulation of Industrial Chemicals
by Joseph Plamondon
Published by iSmithers—A Smithers Group Company
Shawbury, Shrewsbury, Shropshire, UK, 2009
ISBN: 978-1-84735-148-7 (Softback)
A new book by Joseph Plamondon presents a survey of the different approaches to regulating chemicals in the United States and Europe, with the occasional comment about the Canadian system. The Underlying Foundation of Science Used in the Regulation of Industrial Chemicals compares the U.S. federal government’s Toxic Substances Control Act (TSCA) and the European Commission’s (EC) Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) legislation.
Plamondon presents the rationale for developing these regulations clearly as a balance of risk versus benefit. The survey of the risk factors and the way in which each jurisdiction handles the risks is explained and is a valuable insight into the different approaches. While he comments on the underling theory of risk analysis, he does not comment on the bigger political problem of the outrage factor described in Sandman’s work.1 Sandman describes Risk as the Hazard multiplied by Outrage. An equation, which drives the formulation of regulation and the basis for banning products, overwhelming the more logical scientific approach.
The chapter on substance naming conventions is also very thorough and underlines the difference between the U.S. and E.U. approaches, namely that the E.U. relies upon the IUPAC naming conventions and the USA relies upon the Chemical Abstract Services naming. The problems of multiple naming, even within the IUPAC convention, clearly shows that there is a need for a common convention. No doubt this is wishful thinking, as this would reduce the opportunity for playing non-tariff item games in the future.
One common approach that is being pursued is the Simplified Molecular Input Line Entry Specification (SMILES), which is effectively a computer code for a given structure of substance. IUPAC is developing something similar called The International Chemical Identifier (InChI). Again, we need to develop a truly international standard, not a two solitudes approach. However, an interesting thought about these approaches is that they might be more amenable to dealing with characterizing the sizes and shapes of substances, which will likely be needed for regulation of nanomaterials in the future.
Chapters 4 and 5 of the book describe, with examples, some of the difficulties arising from naming issues under TSCA and the challenges arising under REACH. Chapter 6 takes a look at the thorny problem of polymers and the contrasting approaches of the different jurisdictions. Very large molecular weight polymers are treated as benign by systems, but the shorter chain polymers can be reactive and the systems vary in how they handle them.
Chapter 7 discusses the problems that nanotechnology presents to both systems of regulation and outlines some of the recent examples of how each system is handling the issues. It will be some time before any broad approaches are developed, but meanwhile individual issues are being regulated. At some point, there will need to be standardized ways of characterizing “new” substances that are on a nanoscale and shape. Perhaps an extended application of SMILE or InChI would be helpful.
The final chapter provides a summary and an indication of where substantial work to improve the weaknesses of both systems should occur.
We would like to see an attempt to develop a common worldwide system for characterizing substances. IUPAC would be a good vehicle for this. The interpretation of the information and translation into regulations could remain a national prerogative, but it would certainly help to have a common approach there, too. Such a system would help with the risks of chemicals down the value chain and into places where there is no production and no regulation.
TSCA is a mature system that is being improved incrementally. REACH is new, having replaced the former, much weaker E.U. system, and is therefore a step change. It is clear that both systems have their challenges and this book provides a broad understanding of the challenges and an idea about some of the needs for the future.
The number of new and existing acronyms are a challenge for anyone who has an aversion to AFA (Another Flipping Acronym); however, there is a fulsome list of abbreviations in the appendix. IUPAC also comments on the use of abbreviations.2
In summary, we recommend this book to anyone who faces the need to get a new substance registered in North America or Europe. It is not only useful to regulatory affairs practitioners, but also useful background for researchers and marketers, as it indicates the enormity of the task of bringing a product to market.
Outrage and Technical Detail: The Impact of Agency Behaviour on Community Risk Perception, Branden B. Johnson PhD Project Manager, Peter M. Sandman PhD Principal Investigator. Published by New Jersey Department of Environmental Protection, November 1992.
“Use of Abbreviations in the Chemical Literature (IUPAC Recommendations 1979),” David R. Lide, Jr. Pure and Applied Chemistry, 1980, Vol. 52, No. 9, pp. 2229–2232; doi:10.1351/pac198052092229
Bernard West <firstname.lastname@example.org> has a extensive experience in the chemical industry, most recently as CEO of Cansolv Technologies of Montreal, Canada. He is chair of several boards involved in new chemistry developments and is a member of the IUPAC Committee on Chemistry and Industry.
Michael Booth <email@example.com> is the secretary/treasurer of the IUPAC Committee on Chemistry and Industry. He is currently the director of information resources at the Chemical & Allied Industries’ Association in South Africa.
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About the article
Published Online: 2009-09-01
Published in Print: 2009-11-01