Six Classes

Environmental Activism, Government Regulation and YOU

Chemicals used in commerce become regulated in one of two ways: proactively and reactively. Historically, chemical regulation (i.e., restriction, disclosure, labeling, etc.) has been reactive and narrowly focused. Something – often horrible – happens, investigation shows it was due to a particular substance (or class thereof), and that substance becomes regulated.

One classic example is the restriction of polychlorinated biphenyls (PCBs) under the US Environmental Protection Agency’s (EPA) Toxic Substance Control Act (TSCA). In the mid-1970s, just as the US Environmental Protection Agency was starting to flex its muscle (it had been formed in 1970) and the Toxic Substance Control Act was coming into existence, the fact that “General Electric polluted the Hudson River by dispensing polychlorinated biphenyls (PCBs), causing a range of harmful effects to wildlife and people who eat fish from the river or drink the water” for decades finally came to a head. The EPA banned the substance in 1979 as a result.

Many products and production processes were dependent upon PCBs; those all had to be redesigned. This cost time, money and – in the near term – revenue and brand equity.

In the USA, nearly all chemical regulation has been reactive and, due to fundamental weaknesses of TSCA (and thus the EPA), implemented at the state level.

Countries across the world based their national chemical policies on TSCA and ended up mostly being reactive followers – if another market banned a substance, they would ban it too.

In 2006, the European Union passed the Registration, Evaluation, Authorisation and Restriction of Chemicals regulation REACH, which took a fundamentally different approach to the problem. REACH aimed to identify all chemical substances in commerce, identify the manufacturers and importers responsible for placing them on the European markets, and making them responsible for ensuring the safety of these chemicals. It created the European Chemicals Agency (ECHA), in order to manage this process and identify which substances should be considered for regulatory activity. REACH identifies several methods to assess substances (“evaluation”) and control them (“authorisation” and “restriction”, as well as disclosure).

Fundamentally, REACH is more proactive and precautionary in its approach, since it does not necessarily wait for a disaster to occur before allowing ECHA to decide that regulation is needed. Based on toxicological properties as well as use, ECHA can propose ways to improve the safety of the European population and environment (the proposals must then be approved and implemented into regulations by agreement between the European Commission, Parliament and Council). Disasters as well as pressure from EU Member States, environmental groups and others can prioritize its activity (the restriction of bisphenol-A in thermal paper is an example – France proposed that it be restricted through REACH across the entire EU, and it was).

The Challenge to Manufacturers

This approach to chemical control is fundamentally problematic for manufacturers. Chemicals that are already in use in products may become unavailable or disclosable to customers, causing manufacturers to have to “go back to the drawing board” and redesign manufacturing processes and products in order to replace the problematic substance (which, of course, is being used because it has technical properties that meet the necessary functionality/cost/etc. requirements). Replacement is seldom easy or straightforward. I have often written about the study I worked on with Pamela Gordon of Technology Forecasters (now Antea Group) in 2007 to determine the cost to the electronics industry of complying with the EU RoHS Directive. We estimated it had cost US$32.7 billion to implement compliance to RoHS at the time (contact me for the report). This was a Big Deal for the industry.

Manufacturers do not want to have to revisit decisions related to products and manufacturing processes that have already been made because it takes already stretched resources away from new product development and support of existing products, with little direct return (besides the ability to continue selling the product). Fundamentally, manufacturers are broadsided every time something like this happens. In the product development process, decisions are made based on technical properties (e.g., thermal, electrical, mechanical, optical), form/fit/function, and business properties (e.g., availability, cost, volume, etc.). What is missing is the consideration of toxicity, hazard and exposure as technical properties themselves; yet understanding and evaluating them can lead to a determination of likelihood of future regulation.

Assessment of toxicological properties that can lead to restriction or control of substances is not an area most manufacturers are prepared to incorporate as part of the product design process. Industry-maintained lists such as IEC 62474, developed to identify substances that are restricted and “reportable” in electronic products, help to avoid non-compliance right out the gate, but how does a manufacturer “future-proof” a product or production process?

NGOs and Tools to the Rescue?

There are a number of “alternative assessment process” documents to help manufacturers work through the process of comparing substances for a particular use in order to be able to compare toxicological and other “green chemistry” properties (such as energy use, renewable feedstocks, etc.) before deciding. But that requires in-house or contract expertise. Scientists and engineers already perform “alternatives assessments” at every single step of the product design process for a wide variety of technical and functional parameters, but not for toxicity and “greenness”; manufacturers must improve their awareness of and capabilities to address the human health and environmental performance of their products if they want to avoid the frustration and costs of product redesign due to an unforeseen substance restriction.

Green Science Policy Institute (GSP, which, oddly, I helped found quite a few years ago) focuses on bringing science into policy and purchasing decision-making. The Institute is effective at educating regulators and working with manufacturers to anticipate regulation and proactive decisions about substances. A few years ago they developed the “Six Classes” approach to reduce the use of whole families of chemicals of concern in manufactured goods. This science-based approach can prevent “regrettable substitutions” whereby a new molecule has similar capabilities to an existing restricted substance (e.g., decabromodiphenyl ether was replaced by decabromodiphenyl ethane – a molecule with small physical difference, but a very similar toxicological profile).

The Six Classes that “contain many of the harmful substances found in everyday products” are:

• Highly fluorinated chemicals
• Antimicrobials
• Flame retardants
• Bisphenols & phthalates
• Organic solvents
• Certain metals

All are used to one extent or another in electronic products (e.g., antimicrobials can be found in some wearable products) or in production (e.g., solvents). The main message here is one of focus: rather than trying to “boil the ocean” by analyzing every substance, focus on substances in these classes now: they have done the Pareto analysis and these are the “big hitters”. GSP is holding a series of webinars on June 22, June 29 and July 6 to introduce their new short videos and hold discussions with distinguished scientists and thought leaders (I will participate in the one on July 6). The goal is to share information about the Six Classes.

NGOs like GSP are more interested in helping governments regulate in a more effective and sensible manner, while helping manufacturers understand what drives regulation and working with them to both avoid being in its cross-hairs and produce (toxicologically) safer products.

Please sign up and attend these webcasts, ask questions, and think about how your company operates. What will taking a more proactive approach require in terms of information, expertise, business process and funding? Is there a marketing advantage? Can you justify it to management?

If you attend, please participate! And please let me know what you think.

Contact

Visit DCA at www.DesignChainAssociates.com or email me with any questions or comments on this post.